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Clinical NLP Lab 29

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Early diagnosis of human immunodeficiency virus ( HIV ) allows for appropriately timed interventions with improved outcomes , but HIV screening among asymptomatic persons and the general population in Singapore remains low . In 2008 , Singapore ’s Ministry of Health implemented HIV voluntary opt-out screening ( VOS ) for hospitalised adults . We evaluated the outcome of VOS and surveyed reasons for its low uptake in our institution . Methods We assessed the outcomes of the VOS programme from January 2010 to December 2013 at National University Hospital , a 1081-bed tertiary hospital in Singapore . We also examined reasons for opting-in and opting-out using an interviewer – administered structured question naire in a representative sample in January 2013 . Results 107,523 patients fulfilled VOS criteria and were offered HIV screening , of which 5215 ( 4.9 % ) agreed to testing . 4850 ( 93.1 % ) of those who opted-in had an HIV test done . Three ( 0.06 % ) tested positive for HIV . 238 patients ( 14.2 % ) were surveyed regarding reasons for opting-in or out of VOS . 21 ( 8.8 % ) had opted-in . Patients who opted-in were likely to be younger , more educated and reported having more regular sexual partners . Type of housing , number of casual sexual partners , sexual orientation , intravenous drug use , condom use and previous sexually transmitted infection were not associated with deciding to opt-in/out . Patients ’ most common reasons for opting-out were : belief that they were at low risk ( 50.2 % ) , belief that they were too old ( 26.8 % ) , cost ( 6.9 % ) and aversion to venepuncture ( 6.5 % ) . The most common reason for opting-in was desire to know their HIV status ( 47.6 % ) . Conclusion The success of an HIV-VOS program is largely determined by test uptake . Our study showed that the majority of eligible VOS patients opted-out of HIV screening . Given the considerable cost and low yield of this programme , more needs to be done to better equip patients in self-risk assessment and opting in to testing OBJECTIVE We compare outcomes of opt-in and opt-out HIV screening approaches in an urban emergency department . METHODS This was a 1-year prospect i ve observational study comparing 2 6-month screening approaches . Eligibility for opt-in and opt-out screening was identical : aged 15 years or older , medically stable , and able to complete general consent . During the opt-in phase , triage nurses referred patients to HIV testers stationed at triage , who obtained separate opt-in written consent and performed rapid oral fluid tests . During the opt-out phase , registration staff conducted integrated opt-out consent and then referred patients to HIV testers . We assessed the proportion of potentially eligible patients who were offered screening ( screening offer rate ) , the proportion offered screening who accepted ( screening acceptance rate ) , the proportion who accepted screening and subsequently completed testing ( test completion rate ) , and the proportion of potentially eligible patients who completed testing ( overall screening rate ) during each phase . RESULTS For the opt-in versus the opt-out phases , respectively , there were 23,236 potentially eligible patients versus 26,757 , screening offer rate was 27.9 % versus 75.8 % ( P<.001 ) , screening acceptance rate was 62.7 % versus 30.9 % ( P<.001 ) , test completion rate was 99.8 % versus 74.6 % ( P<.001 ) , and overall screening rate was 17.4 % versus 17.5 % ( P = .90 ) . CONCLUSION A significantly higher proportion of patients were offered HIV screening with an opt-out approach at registration . However , this was offset by much higher screening acceptance and test completion rates with the opt-in approach at triage . Overall screening rates with the 2 approaches were nearly identical Background The Centers for Disease Control and Prevention recommends nontargeted opt-out HIV screening in healthcare setting s. Cost effectiveness is critical when considering potential screening methods . Our goal was to compare programmatic costs of nontargeted opt-out rapid HIV screening with physician-directed diagnostic rapid HIV testing in an urban emergency department ( ED ) as part of the Denver ED HIV Opt-Out Trial . Methods This was a prospect i ve cohort study nested in a larger quasi-experiment . Over 16 months , nontargeted rapid HIV screening ( intervention ) and diagnostic rapid HIV testing ( control ) were alternated in 4-month time blocks . During the intervention phase , patients were offered HIV testing using an opt-out approach during registration ; during the control phase , physicians used a diagnostic approach to offer HIV testing to patients . Each method was fully integrated into ED operations . Direct program costs were determined using the perspective of the ED . Time-motion methodology was used to estimate personnel activity costs . Costs per patient newly-diagnosed with HIV infection by intervention phase , and incremental cost effectiveness ratios were calculated . Results During the intervention phase , 28,043 eligible patients were included , 6,933 ( 25 % ) completed testing , and 15 ( 0.2 % , 95 % CI : 0.1%–0.4 % ) were newly-diagnosed with HIV infection . During the control phase , 29,925 eligible patients were included , 243 ( 0.8 % ) completed testing , and 4 ( 1.7 % , 95 % CI : 0.4%–4.2 % ) were newly-diagnosed with HIV infection . Total annualized costs for nontargeted screening were $ 148,997 , whereas total annualized costs for diagnostic HIV testing were $ 31,355 . The average costs per HIV diagnosis were $ 9,932 and $ 7,839 , respectively . Nontargeted HIV screening identified 11 more HIV infections at an incremental cost of $ 10,693 per additional infection . Conclusions Compared to diagnostic testing , nontargeted HIV screening was more costly but identified more HIV infections . More effective and less costly testing strategies may be required to improve the identification of patients with undiagnosed HIV infection in the ED OBJECTIVES The Centers for Disease Control and Prevention recommends routine opt-out HIV screening in health care setting s. Our goal was to evaluate the feasibility and yield of this strategy in the emergency department ( ED ) and to compare it to the expected yield of physician-directed testing . METHODS This is a cross-sectional study in an urban ED during r and om shifts over 1 year . Patients were ineligible for screening if they were younger than 18 years or older than 64 , a prisoner , a victim of sexual assault , in an ED resuscitation room , or had altered mental status . Research associates administered rapid HIV tests and conducted st and ardized interviews . The patients ' ED physician , blinded to the HIV result , was asked if they would have ordered a rapid HIV test if it had been available . RESULTS Of 7756 ED patients , 3957 ( 51 % ) were eligible for HIV screening , and 2811 ( 71 % ) of those did not opt out . Routine testing yielded 9 new HIV cases ( 0.32 % of those tested ; 95 % confidence interval , 0.16%-0.63 % ) . Physician-directed testing would have missed most of these infections : 2 of the 785 patients identified by physicians for testing would have been newly diagnosed with HIV ( 0.25 % ; 95 % confidence interval , 0.04%-1.0 % ) . Of the 9 new HIV cases , 5 established HIV care , and their median CD4 count was 201 cells/μL ( range , 71 - 429 cells/μL ) . CONCLUSIONS Routine opt-out HIV screening was feasible and accepted by a majority of ED patients . The yield of this strategy only modestly exceeded what may have been observed with physician-directed testing STUDY OBJECTIVE A clinical prediction tool , the Denver HIV Risk Score , was recently developed to help identify patients with increased probability of undiagnosed HIV infection . Our goal was to compare targeted rapid HIV screening using the Denver HIV Risk Score to nontargeted rapid HIV screening in an urban emergency department ( ED ) and urgent care . METHODS We used a prospect i ve , before-after design at an urban medical center with an approximate annual census of 110,000 visits . Patients aged 13 years or older were eligible for screening . Targeted HIV screening of patients identified as high-risk by nurses using the Denver HIV Risk Score during medical screening was compared to nontargeted HIV screening offered by medical screening nurses during 2 separate 4-month time periods . The primary outcome was newly diagnosed HIV-infected patients . RESULTS 28,506 patients presented during the targeted phase , 1,718 were identified as high-risk , and 551 completed HIV testing . Of these , 7 ( 1.3 % , 95 % confidence interval [ CI ] 0.5 % to 2.6 % ) were newly diagnosed with HIV infection . 29,510 patients presented during the nontargeted phase and 3,591 completed HIV testing . Of these , 7 ( 0.2 % , 95 % CI 0.1 % to 0.4 % ) were newly diagnosed with HIV infection . Targeted HIV screening was significantly associated with identification of newly diagnosed HIV infection when compared to nontargeted screening , adjusting for patient demographics and payer status ( relative risk [ RR ] 10.4 , 95 % CI 3.4 to 32.0 ) . CONCLUSION Targeted HIV screening using the Denver HIV Risk Score was strongly associated with new HIV diagnoses when compared to nontargeted screening . Although both HIV screening methods identified the same absolute number of newly diagnosed patients , significantly fewer tests were required during the targeted phase to achieve the same effect OBJECTIVES The objective was to evaluate patient acceptance and underst and ing of nontargeted opt-out and opt-in rapid human immunodeficiency virus ( HIV ) screening using computerized kiosks in the emergency department ( ED ) . METHODS This study was a prospect i ve quasi-experiment in an urban hospital with an annual ED and urgent care census of 120,000 visits . During medical screening , patients 13 years and older were offered rapid HIV screening using kiosks and opt-out consent ( October 2009 ) or opt-in consent ( December 2009 ) . R and om time blocks were used to administer structured surveys to evaluate patient underst and ing of the testing process . RESULTS During the opt-out phase , 6,602 were offered testing , and of these 3,993 ( 61 % ) did not opt-out and 886 ( 13 % ) completed screening . During the opt-in phase , 5,781 were offered testing , and of these 930 ( 16 % ) opted-in and 389 ( 7 % ) completed screening ( absolute difference = 6 % , 95 % confidence interval [ CI ] = 5 % to 8 % ) . During the opt-out phase , 330 patients completed the survey . Of these , 201 ( 61 % ) did not opt-out , but 108 ( 54 % , 95 % CI = 47 % to 61 % ) responded that they had not been informed about an HIV test . Of the 84 patients who had been informed , 32 ( 38 % , 95 % CI = 28 % to 49 % ) responded that they had not agreed to an HIV test . During the opt-in phase , 416 completed the survey . Of these , 80 ( 19 % ) agreed to testing and two ( 3 % , 95 % CI = 0.3 % to 9 % ) responded that they had not been informed about an HIV test . Of the 74 patients who had been informed , only two ( 3 % , 95 % CI = 0.3 % to 9 % ) responded that they had not agreed to an HIV test . CONCLUSIONS Computerized kiosks can be successfully used to perform nontargeted rapid HIV screening in EDs . However , when using this approach , patient underst and ing of opt-in consent is significantly better than opt-out consent BACKGROUND To lower the number of undiagnosed infections and to improve early detection , international health agencies have promoted nontargeted human immunodeficiency virus ( HIV ) screening in health care setting s , including emergency departments ( EDs ) . This strategy remains controversial and has yet to be tested on a large scale . We assessed the public health impact of nontargeted HIV-rapid test ( RT ) screening among ED patients in the metropolitan area of Paris ( 11.7 million inhabitants ) , where half of France 's new HIV cases are diagnosed annually . METHODS During a r and omly assigned 6-week period for each of the 29 participating EDs , 18- to 64-year-old patients who were able to provide consent for HIV testing were offered a fingerstick whole-blood HIV RT . Main outcome measures were the number of patients tested for HIV and their characteristics vs those of the general metropolitan Paris population and the proportion of newly diagnosed HIV-positive patients among those tested and their characteristics vs those from the national HIV case surveillance . RESULTS Among 138,691 visits , there were 78,411 eligible patients , 20,962 of whom ( 27.0 % ) were offered HIV RT ; 13,229 ( 63. \n Output:\n " }, { "from": "agent", "value": "In this meta- analysis , the testing uptake of the opt-out strategy was not different from that of the opt-in strategy to detect new cases of HIV infection in EDs" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Examination of differences between primary alcohol and drug abusing adolescents can provide valuable direction to intervention efforts , though little research in this area has been conducted . The current study compared primary alcohol and primary drug abusing runaway adolescents who were r and omly assigned to family therapy or treatment as usual . Baseline differences , as well as response to treatment , were examined separately for alcohol and drug use and by gender . Although few baseline differences were found , hierarchical linear modeling indicated that alcohol and drug abusing male and female adolescents responded differently to therapy . Primary drug using males showed poorer alcohol use outcomes than did primary alcohol abusers . Specifically , alcohol use increased for primary drug using males receiving family therapy , while drug use decreased in all groups . Findings suggest that alcohol and drug use outcomes might be improved at treatment planning through consideration of client 's gender and primary alcohol versus drug use PURPOSE We evaluate the efficacy of a short family intervention in reducing sexual risk behavior , drug use , and delinquent behaviors among homeless youth . METHODS A r and omized controlled trial of 151 families with a homeless adolescent aged 12 to 17 years . Between March 2006 and June 2009 , adolescents were recruited from diverse sites in Southern California and were assessed at recruitment ( baseline ) , and at 3 , 6 , and 12 months later . Families were r and omly assigned to an intervention condition with five weekly home-based intervention sessions or a control condition ( st and ard care ) . Main outcome measures reflect self-reported sexual risk behavior , substance use , and delinquent behaviors over the past 90 days . RESULTS Sexual risk behavior ( e.g. , mean number of partners ; p < .001 ) , alcohol use ( p = .003 ) , hard drug use ( p < .001 ) , and delinquent behaviors ( p = .001 ) decreased significantly more during 12 months in the intervention condition compared with the control condition . Marijuana use , however , significantly increased in the intervention condition compared with the control condition ( p < .001 ) . CONCLUSIONS An intervention to reengage families of homeless youth has significant benefits in reducing risk over 12 months Runaway youth report a broader range and higher severity of substance-related , mental health and family problems relative to non-runaway youth . Most studies to date have collected self-report data on the family and social history ; virtually no research has examined treatment effectiveness with this population . This study is a treatment development project in which 124 runaway youth were r and omly assigned to ( 1 ) ecologically based family therapy ( EBFT ) or ( 2 ) service as usual ( SAU ) through a shelter . Youth completed an intake , posttreatment , 6 and 12 months follow-up assessment . Youth assigned to EBFT reported greater reductions in overall substance abuse compared to youth assigned to SAU while other problem areas improved in both conditions . Findings suggest that EBFT is an efficacious intervention for this relatively severe population of youth This prospect i ve review was design ed to determine the effectiveness of a broad-spectrum health intervention program for homeless and runaway youth . Diagnosis , treatment , and counseling for drug use , sexually transmitted diseases ( STDs ) , and other health issues were provided all new admissions to a residential care facility during a 2-month enrollment . Education was continued during a 9-month follow-up period based on the program entitled Bright Futures , previously developed and published by the National Center for Education in Maternal and Child Health . Sixty percent of the 106 study residents had STDs on admission and 7 % developed new STDs after completing therapy and undergoing counseling . Drug dependence was reduced from 41 % to 3 % , and 42 % achieved full-time or part-time employment . Fifty-nine percent completed hepatitis B immunization with the 3-dose series . This experience suggests that an organized program of interventions in a residential care facility for homeless teenagers can significantly reduce drug dependence and STDs The broad objective of this study was to underst and the incidence and severity of aggression among sexually abused girls who were trafficked and who were then further used for commercial sexual exploitation ( referred to subsequently as sexually abused trafficked girls ) . In addition , the impact of counseling for minimizing aggression in these girls was investigated . A group of 120 sexually abused trafficked Indian girls and a group of 120 nonsexually abused Indian girls , aged 13 to 18 , participated in the study . The sexually abused trafficked girls were purposively selected from four shelters located in and around Kolkata , India . The nonsexually abused girls were selected r and omly from four schools situated near the shelters , and these girls were matched by age with the sexually abused trafficked girls . Data were collected using a Background Information Schedule and a st and ardized psychological test , that is , The Aggression Scale . Results revealed that 16.7 % of the girls were first sexually abused between 6 and 9 years of age , 37.5 % between 10 and 13 years of age , and 45.8 % between 14 and 17 years of age . Findings further revealed that 4.2 % of the sexually abused trafficked girls demonstrated saturated aggression , and 26.7 % were highly aggressive , that is , extremely frustrated and rebellious . Across age groups , the sexually abused trafficked girls suffered from more aggression ( p < .05 ) , compared with the nonvictimized girls . Psychological interventions , such as individual and group counseling , were found to have a positive impact on the sexually abused trafficked girls . These findings should motivate counselors to deal with sexually abused children . It is also hoped that authorities in welfare homes will underst and the importance of counseling for sexually abused trafficked children , and will appoint more counselors for this purpose Homeless youth face various health challenges . The effectiveness of a short intervention to promote sexual health in 572 homeless 16—23-year-olds ( M = 19.467 + 1.89 ) was conducted using a quasi-experimental repeated measures design . Data collected at three time points ( pre-intervention , immediately post-intervention and follow-up ) via laptop computers were analyzed using multivariate general linear mixed models . A significant condition by time interaction was found for self-reported AIDS/STD knowledge ; intervention participants had higher scores at first post-test . Females scored significantly higher on cognitive and behavioral outcomes while males reported significantly more sexual risk-taking behaviors . Findings support gender-specific interventions Runaway youth are 6–12 times more likely to become infected with HIV than other youth . Using a quasi-experimental design , the efficacy of an HIV prevention program was evaluated over 2 years among 2 groups of runaways : ( 1 ) those at 2 shelters who received Street Smart , an intensive HIV intervention program , and ( 2 ) youth at 2 control shelters . Street Smart provided youth with access to health care and condoms and delivered a 10-session skill-focused prevention program based on social learning theory to youth . Prior to analysis of the intervention 's outcomes , propensity scores were used to identify comparable subgroups of youth in the intervention ( n = 101 ) and control conditions ( n = 86 ) . Compared to females in the control condition , females in the intervention condition significantly reduced their unprotected sexual acts at 2 years and alcohol use , marijuana use , and the number of drugs used over 12 months . Male adolescents in the intervention condition showed significant reductions in marijuana use over 6 months compared to control youth . Adolescent HIV prevention programs must proactively identify mechanisms for maintaining behavior change over the long-term , and innovative research design s are needed to allow examination of agency-level interventions While many studies provide useful information on the risk behaviors in which homeless youth engage , few prior studies evaluate Human Immunodeficiency Virus ( HIV ) risk related reduction strategies . In this study , homeless youth ( n = 180 ) were recruited from a drop-in center and r and omly assigned to one of two conditions , either an integrated individual cognitive-behavioral treatment and HIV prevention intervention that focused on skills building and education or to treatment as usual . All youth were assessed at entry into the program and at 3 and 6 month follow-up points . Findings showed an interaction between treatment condition , age and time . In the interaction , youth assigned to the integrated treatment reported greater condom usage than youth assigned to treatment as usual , with younger youth assigned to treatment as usual showing no change in condom use . The number of sexual partners reported by youth in both treatment conditions was also reduced over time . However , youth in both conditions continued to engage in other high-risk behaviors . The integrated treatment findings are promising and suggest that interventions which target both HIV risk behavior in addition to other life areas ( substance use , mental health and housing ) among homeless youth may be necessary in order to significantly impact high-risk behaviors among this unique group The short-term results of a r and omized trial testing a brief feedback and motivational intervention for substance use among homeless adolescents are presented . Homeless adolescents ages 14 - 19 ( N = 285 ) recruited from drop-in centers at agencies and from street intercept were r and omly assigned to either a brief motivational enhancement ( ME ) group or 1 of 2 control groups . The 1-session motivational intervention presented personal feedback about patterns of risks related to alcohol or substance use in a style consistent with motivational interviewing . Follow-up interviews were conducted at 1 and 3 months postintervention . Youths who received the motivational intervention reported reduced illicit drug use other than marijuana at 1-month follow-up compared with youths in the control groups . Treatment effects were not found with respect to alcohol or marijuana . Post hoc analyses within the ME group suggested that those who were rated as more engaged and more likely to benefit showed greater drug use reduction than did those rated as less engaged . Limitations of the study are discussed as are implication s for development of future substance use interventions for this high-risk group This prospect i ve review was design ed to determine the effectiveness of a broad-spectrum health intervention program for homeless and runaway youth . Diagnosis , treatment , and counseling for drug use , sexually transmitted diseases ( STDs ) , and other health issues were provided to all new admissions to a residential care facility during a 7(1/2)-year enrollment . Education was continued during a minimum follow-up period of 9 months based on the program entitled Bright Futures , previously developed and published by the National Center for Education in Maternal and Child Health . Fifty-four percent of the study residents had STDs on admission , and 9 % developed new STDs after completing therapy and undergoing counseling . Drug dependence was reduced from 47 % to 4 % , and 46 % achieved full-time or part-time employment . Sixty-three percent completed hepatitis B immunization with the 3-dose series . This experience suggests that an organized program of interventions in a residential care facility for homeless teenagers can significantly reduce drug dependence and STDs ABSTRACT This study compared the costs and outcomes associated with three treatment programs that served 149 individuals with dual disorders ( i.e. , individuals with co-occurring severe mental illness and substance use disorders ) who were homeless at baseline . The three treatment programs were : Integrated Assertive Community Treatment ( IACT ) , Assertive Community Treatment only ( ACTO ) , and st and ard care ( Control ) . Participants were r and omly assigned to treatment and followed for a period of 24 months . Clients in the IACT and ACTO programs were more satisfied with their treatment program and reported more days in stable housing than clients in the Control condition . There were no significant differences between treatment groups on psychiatric symptoms and substance use . The average total costs associated with the IACT and Control conditions were significantly less than the average total costs for the ACTO condition A brief motivational intervention with 117 homeless adolescents was evaluated using a r and omized design and 3-month follow-up . The intervention was design ed to raise youths ' concerns about their substance use , support harm reduction , and encourage greater service utilization at a collaborating agency . The study was design ed to strengthen initial promising results of an earlier study ( P. L. Peterson , J. S. Baer , E. A. Wells , J. A. Ginzler , & S. B. Garrett , 2006 ) . Several modifications in the clinical protocol were included to enhance engagement with the intervention . Analyses revealed no significant benefits for intervention participants when homeless youths ' substance use rates were compared with those of control participants . Service utilization during the intervention period increased for those receiving the intervention but returned to baseline levels at follow-up . Participants reported overall reductions in substance use over time . Differences between sampling methods for the current and previous study are discussed , as are the limitations of brief interventions with this population . Future research needs to eluci date mechanisms of change and service engagement for highly vulnerable youth OBJECTIVE This research examined the impact of completing a question naire about blood donation on subsequent donation behavior among a large sample of experienced blood donors . DESIGN Participants ( N=4672 ) were r and omly assigned to an experimental condition that received a postal question naire measuring cognitions about donation or a control condition that did not receive a question naire . MAIN OUTCOME MEASURES Number of registration s at blood drives and number of successful blood donations were assessed using objective records both 6 months and 12 months later . RESULTS Findings indicated that , compared to control participants , the mean frequency of number of registration s at blood drives among participants in the experimental group was 8.6 % greater at 6 months ( p<.0.007 ) , and was 6.4 % greater at 12 months ( p<.035 ) . Significant effects were also observed for successful blood donations at 6 months ( p<.001 ) and 12 months ( p<.004 ) . CONCLUSION These findings provide the first evidence that the mere measurement is relevant to promoting consequential health behaviors . Implication s of the research for intervention evaluation are discussed This study examined the effects of cognitive- \n Output:\n " }, { "from": "agent", "value": "The interventions being evaluated consisted of time limited therapeutically based programmes which did not prove more effective than st and ard shelter or drop-in services for most outcomes and in most studies .\nThere were favourable changes from baseline in outcomes for most particpants in therapy interventions and also in st and ard services .\nThe review discussion section included consideration of the relevance of the findings for LMIC setting s. AUTHORS ' CONCLUSIONS Analysis across the included studies found no consistently significant benefit for the ' new ' interventions compared to st and ard services for street-connected children and young people ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND AND OBJECTIVES Vascular calcification and endothelial dysfunction contribute to the development of cardiovascular disease in patients with chronic kidney disease ( CKD ) . Sevelamer , a non-calcium-based phosphate binder , has been shown to attenuate cardiovascular calcification in CKD patients , although the exact mechanism has not been clarified . This study was design ed to investigate the effect of short-term sevelamer treatment on both serum fetuin-A concentrations and endothelial dysfunction seen in CKD patients . DESIGN , SETTING , PARTICIPANTS , & MEASUREMENTS Fifty nondiabetic stage 4 CKD patients whose phosphate levels were > or = 5.5 mg/dl were enrolled in this 8-wk r and omized prospect i ve study . Thirty-six healthy volunteers served as matched controls . Patients were treated with either sevelamer ( n = 25 , 12 males ) or calcium acetate ( n = 25 , 13 males ) . Fetuin-A , high-sensitivity C-reactive protein , Ca x PO4 product , flow-mediated dilation ( FMD ) , insulin , and homeostasis model assessment ( HOMA ) were obtained at baseline and after the treatment period . RESULTS As expected , CKD patients had significantly lower levels of fetuin-A and FMD , and significantly higher levels of intact parathyroid hormone , Ca x PO4 product , and high-sensitivity C-reactive protein than controls ( P < 0.001 for all ) . The use of sevelamer led to a significant increase in the fetuin-A concentration with improvement in FMD , whereas no significant difference was observed in the calcium acetate group . In a multiple regression analysis , FMD levels were independently related to fetuin-A both before ( beta = 0.63 , P < 0.001 ) and after ( beta = 0.38 , P = 0.004 ) treatment . CONCLUSIONS This small , r and omized , prospect i ve study shows that short-term sevelamer treatment significantly increases fetuin-A levels and improves FMD in nondiabetic stage 4 CKD patients Background . Sevelamer carbonate is an improved , buffered form of sevelamer hydrochloride developed for the treatment of hyperphosphataemia in CKD patients . Sevelamer carbonate formulated as a powder for oral suspension presents a novel , patient-friendly alternative to tablet phosphate binders . This study compared the safety and efficacy of sevelamer carbonate powder with sevelamer hydrochloride tablets in CKD patients on haemodialysis . Methods . This was a multi-centre , open-label , r and omized , crossover design study . Thirty-one haemodialysis patients were r and omly assigned to either sevelamer carbonate powder or sevelamer hydrochloride tablets for 4 weeks followed by a crossover to the other regimen for an additional 4 weeks . Results . The mean serum phosphorus was 1.6 ± 0.5 mmol/L ( 5.0 ± 1.5 mg/dL ) during sevelamer carbonate powder treatment and 1.7 ± 0.4 mmol/L ( 5.2 ± 1.1 mg/dL ) during sevelamer hydrochloride tablet treatment . Sevelamer carbonate powder and sevelamer hydrochloride tablets are equivalent in controlling serum phosphorus ; the geometric least square mean ratio was 0.95 ( 90 % CI 0.87–1.03 ) . No statistically significant or clinical ly meaningful differences were observed in calcium × phosphorus product and lipid levels between sevelamer carbonate powder and sevelamer hydrochloride tablets . Serum bicarbonate levels increased 2.7 ± 3.7 mmol/L ( 2.7 ± 3.7 mEq/L ) during sevelamer carbonate treatment . No statistically significant change in bicarbonate was observed during sevelamer hydrochloride treatment . Sevelamer carbonate powder and sevelamer hydrochloride were well tolerated during this study . Conclusions . Sevelamer carbonate powder and sevelamer hydrochloride tablets are equivalent in controlling serum phosphorus and well tolerated in CKD patients on haemodialysis . Bicarbonate levels improved only during sevelamer carbonate treatment . Sevelamer carbonate powder should provide a welcomed new option for the treatment of hyperphosphataemia for CKD patients on dialysis BACKGROUND JTT-751 is a novel phosphate binder containing ferric citrate as the active ingredient . METHODS In this Phase 3 , multicenter , r and omized , open-label , parallel-group study , we compared the efficacy and safety of JTT-751 and sevelamer hydrochloride in patients undergoing hemodialysis . A total of 230 patients with a serum phosphate ≥1.97 and < 3.23 mmol/L were r and omized to JTT-751 ( dose adjusted between 1.5 and 6.0 g/day ) or sevelamer hydrochloride ( dose adjusted between 3.0 and 9.0 g/day ) for 12 weeks . The primary outcome was change in serum phosphate from baseline to end of treatment . Secondary outcomes included the changes in corrected serum calcium and intact parathyroid hormone ( PTH ) . The changes in ferritin , transferrin saturation and erythropoiesis-stimulating agent dose were additional outcomes . RESULTS Changes in serum phosphate at the end of treatment were -0.82 mmol/L in the JTT-751 group and -0.78 mmol/L in the sevelamer group , establishing non-inferiority of JTT-751 compared with sevelamer ( least squares mean , -0.03 mmol/L ; 95 % confidence interval , -0.13 to 0.07 mmol/L ) . Corrected serum calcium increased and PTH decreased from baseline within both groups ; changes between groups were similar . Gastrointestinal disorders were the most common adverse events in both groups ; the incidence of diarrhea was higher in the JTT-751 group , while constipation occurred frequently in the sevelamer group . Treatment with JTT-751 result ed in significant relative increases in serum ferritin and transferrin saturation . CONCLUSIONS Efficacy and safety of JTT-751 was comparable to sevelamer in patients on hemodialysis with hyperphosphatemia . Differential adverse effects were observed ; biochemical markers of iron status increased in patients treated with JTT-751 . TRIAL REGISTRATION NUMBER CTI-111433 ( The Japan Pharmaceutical Information Center at : http//www . clinical trials.jp ) . Date of registration : 7 March 2011 Background and Aims : Calcium-containing phosphate binders have been shown to increase the progression of vascular calcification in hemodialysis patients . This is a prospect i ve study that compares the effects of calcium acetate and sevelamer on coronary calcification ( CAC ) and bone histology . Methods : 101 hemodialysis patients were r and omized for each phosphate binder and su bmi tted to multislice coronary tomographies and bone biopsies at entry and 12 months . Results : The 71 patients who concluded the study had similar baseline characteristics . On follow-up , the sevelamer group had higher levels of intact parathyroid hormone ( 498 ± 352 vs. 326 ± 236 pg/ml , p = 0.017 ) , bone alkaline phosphatase ( 38 ± 24 vs. 28 ± 15 U/l , p = 0.03 ) and deoxypyridinoline ( 135 ± 107 vs. 89 ± 71 nmol/l , p = 0.03 ) and lower LDL cholesterol ( 74 ± 21 vs. 91 ± 28 mg/dl , p = 0.015 ) . Phosphorus ( 5.8 ± 1.0 vs. 6 ± 1.0 mg/dl , p = 0.47 ) and calcium ( 1.27 ± 0.07 vs. 1.23 ± 0.08 mmol/l , p = 0.68 ) levels did not differ between groups . CAC progression ( 35 vs. 24 % , p = 0.94 ) and bone histological diagnosis at baseline and 12 months were similar in both groups . Patients of the sevelamer group with a high turnover at baseline had an increase in bone resorption ( eroded surface , ES/BS = 9.0 ± 5.9 vs. 13.1 ± 9.5 % , p = 0.05 ) , whereas patients of both groups with low turnover at baseline had an improvement in bone formation rate ( BFR/BS = 0.015 ± 0.016 vs. 0.062 ± 0.078 , p = 0.003 for calcium and 0.017 ± 0.016 vs. 0.071 ± 0.084 μm3/μm2/day , p = 0.010 for sevelamer ) . Conclusions : There was no difference in CAC progression or changes in bone remodeling between the calcium and the sevelamer groups BACKGROUND AND OBJECTIVES Higher phosphate is associated with mortality in dialysis patients but few prospect i ve studies assess this in nondialysis patients managed in an outpatient nephrology clinic . This prospect i ve longitudinal study examined whether phosphate level was associated with death in a referred population . DESIGN , SETTING , PARTICIPANTS & MEASUREMENTS Patients ( 1203 ) of nondialysis chronic kidney disease ( CKD ) in the Chronic Renal Insufficiency St and ards Implementation Study were assessed . Survival analyses were performed for quartiles of baseline phosphate relative to GFR , 12-month time-averaged phosphate , and baseline phosphate according to published phosphate targets . RESULTS Mean ( SD ) eGFR was 32 ( 15 ) ml/min per 1.73 m(2 ) , age 64 ( 14 ) years , and phosphate 1.2 ( 0.30 ) mmol/L. Cox multivariate adjusted regression in CKD stages 3 to 4 patients showed an increased risk of all-cause and cardiovascular mortality in the highest quartile compared with that in the lowest quartile of phosphate . No association was found in CKD stage 5 patients . Patients who had values above recommended targets for phosphate control had increased risk of all-cause and cardiovascular death compared with patients below target . The highest quartile compared with the lowest quartile of 12-month time-averaged phosphate was associated with an increased risk of mortality . CONCLUSIONS In CKD stages 3 to 4 patients , higher phosphate was associated with a stepwise increase in mortality . As phosphate levels below published targets ( as opposed to within them ) are associated with better survival , guidelines for phosphate in nondialysis CKD patients should be re-examined . Intervention trials are required to determine whether lowering phosphate will improve survival Objective . To evaluate the influence of sevelamer hydrochloride and calcium acetate on biomarkers of bone turnover in patients with hyperphosphatemia receiving hemodialysis . Methods . In this prospect i ve , open-label , r and omized , active-controlled study , 70 patients ( 38 men and 32 women ) with hyperphosphatemia ( serum phosphorus level > 6.0 mg/dL ) underwent a two-week washout period and were r and omly selected to receive sevelamer hydrochloride ( n = 37 ) or calcium acetate ( n = 33 ) for eight weeks . Changes in serum levels of intact parathyroid hormone ( iPTH ) , alkaline phosphatase ( Alk-P ) , phosphorus , and calcium were measured and compared . Results . After eight weeks of treatment , calcium acetate lowered iPTH levels significantly more than sevelamer hydrochloride did ( −178.0 vs. −69.0 pg/mL , p = 0.0019 ) . Levels of Alk-P were significantly elevated in patients given sevelamer hydrochloride compared with levels in those given calcium acetate treatment ( 24.09 vs. 7.45 U/L , p = 0.0014 ) . Changes in serum phosphorus levels did not differ between sevelamer hydrochloride ( −1.93 mg/dL ) and calcium acetate ( −2.5 mg/dL ) at the end of the study ( p = 0.0514 ) . Changes in the calcium and phosphorous product did not significantly differ between the sevelamer-hydrochloride group ( −18.06 mg2/dL2 ) and the calcium-acetate group ( −19.05 mg2/dL2 , p = 0.6764 ) . Fifteen patients ( 45.5 % ) treated with calcium acetate had hypercalcemia ( serum-adjusted calcium level > 10.5 mg/dL ) ; the rate was significantly higher than that of patients treated with sevelamer ( five [ 13.5 % ] of 37 , p = 0.0039 ) . Conclusion . Treatment with sevelamer hydrochloride had the advantage of maintaining stable iPTH levels and elevating Alk-P levels while lowering serum phosph \n Output:\n " }, { "from": "agent", "value": "Compared with calcium-based binders , sevelamer reduced serum calcium , low-density lipoprotein and coronary artery calcification , but increased intact parathyroid hormone .\nLanthanum had less favorable impact on biochemical parameters .\nSevelamer was associated with a nonsignificant reduction in mortality and significantly lower hospitalization rates and hypercalcemia compared with calcium-based binders .\nHowever , differences in important outcomes , such as cardiac events , fractures , calciphylaxis , hyperchloremic acidosis and health-related quality of life remain understudied .\nLanthanum and iron-based binders did not show superiority for any clinical ly relevant outcomes ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: PURPOSE In metastatic colorectal cancer , phase III studies have demonstrated the superiority of fluorouracil ( FU ) with leucovorin ( LV ) in combination with irinotecan or oxaliplatin over FU + LV alone . This phase III study investigated two sequences : folinic acid , FU , and irinotecan ( FOLFIRI ) followed by folinic acid , FU , and oxaliplatin ( FOLFOX6 ; arm A ) , and FOLFOX6 followed by FOLFIRI ( arm B ) . PATIENTS AND METHODS Previously untreated patients with assessable disease were r and omly assigned to receive a 2-hour infusion of l-LV 200 mg/m(2 ) or dl-LV 400 mg/m(2 ) followed by a FU bolus 400 mg/m(2 ) and 46-hour infusion 2,400 to 3,000 mg/m(2 ) every 46 hours every 2 weeks , either with irinotecan 180 mg/m(2 ) or with oxaliplatin 100 mg/m(2 ) as a 2-hour infusion on day 1 . At progression , irinotecan was replaced by oxaliplatin ( arm A ) , or oxaliplatin by irinotecan ( arm B ) . RESULT Median survival was 21.5 months in 109 patients allocated to FOLFIRI then FOLFOX6 versus 20.6 months in 111 patients allocated to FOLFOX6 then FOLFIRI ( P = .99 ) . Median second progression-free survival ( PFS ) was 14.2 months in arm A versus 10.9 in arm B ( P = .64 ) . In first-line therapy , FOLFIRI achieved 56 % response rate ( RR ) and 8.5 months median PFS , versus FOLFOX6 which achieved 54 % RR and 8.0 months median PFS ( P = .26 ) . Second-line FOLFIRI achieved 4 % RR and 2.5 months median PFS , versus FOLFOX6 which achieved 15 % RR and 4.2 months PFS . In first-line therapy , National Cancer Institute Common Toxicity Criteria grade 3/4 mucositis , nausea/vomiting , and grade 2 alopecia were more frequent with FOLFIRI , and grade 3/4 neutropenia and neurosensory toxicity were more frequent with FOLFOX6 . CONCLUSION Both sequences achieved a prolonged survival and similar efficacy . The toxicity profiles were different Background : The impact of thymidylate synthase ( TYMS ) and UDP-glucoronosyltransferase 1A ( UGT1A ) germline polymorphisms on the outcome of colorectal cancer ( CRC ) patients treated with irinotecan plus 5-fluorouracil ( irinotecan/5FU ) is still controversial . Our objective was to define a genetic-based algorithm to select patients to be treated with irinotecan/5FU . Methods : Genotyping of TYMS ( 5′TRP and 3′UTR ) , UGT1A1 * 28 , UGT1A9 * 22 and UGT1A7 * 3 was performed in 149 metastatic CRC patients treated with irinotecan/5FU as first-line chemotherapy enrolled in a r and omised phase 3 study . Their association with response , toxicity and survival was investigated by univariate and multivariate statistical analysis . Results : TYMS 3TRP/3TRP genotype was the only independent predictor of tumour response ( OR=5.87 , 95 % confidence interval (CI)=1.68–20.45 ; P=0.005 ) . UGT1A1 * 28/*28 was predictive for haematologic toxicity ( OR=6.27 , 95 % CI=1.09–36.12 ; P=0.04 ) , specifically for neutropenia alone ( OR=6.40 , 95 % CI=1.11–37.03 ; P=0.038 ) or together with diarrhoea ( OR=18.87 , 95 % CI=2.14–166.67 ; P=0.008 ) . UGT1A9 * 1/*1 was associated with non-haematologic toxicity ( OR=2.70 , 95 % CI=1.07–6.82 ; P=0.035 ) . Haplotype VII ( all non-favourable alleles ) was associated with non-haematologic toxicity ( OR=2.11 , 95 % CI=1.12–3.98 ; P=0.02 ) . Conclusion : TYMS and UGT1A polymorphisms influence on tumour response and toxicities derived from irinotecan/5FU treatment in CRC patients . A genetic-based algorithm to optimise treatment individualisation is proposed The aim of this study ( JGOG1063 ) was to determine the recommended dose ( RD ) for combination chemotherapy with irinotecan hydrochloride ( CPT-11 ) and nedaplatin ( NDP ) for advanced cervical squamous cell carcinoma . CPT-11 was given intravenously in fixed doses of 60 mg/m2 on days 1 and 8 and NDP , in escalating doses , on day 1 , every 4 weeks . A total of 15 patients were enrolled in the study . At level 1 ( NDP : 50 mg/m2 ) , one of the 3 patients developed grade 3 diarrhea , so 3 additional patients were enrolled at this level . As none of the 3 additional patients exhibited dose-limiting toxicity , level 1 was elevated to level 2 ( NDP : 60 mg/m2 ) . The maximum tolerated dose was not reached , even at the highest dose level ( level 4 ; NDP : 80 mg/m2 ) . No further dose escalation was carried out , and level 4 ( CPT-11 : 60 mg/m2 , NDP : 80 mg/m2 ) was determined as the RD Purpose To investigate the activity of gemcitabine combined with irinotecan in patients with relapsed small cell lung cancer ( SCLC ) . Patients and methods SCLC patients who had experienced treatment failure with one prior chemotherapy were eligible . Patients were required to have a performance status of 0–2 and adequate organ function . Treatment consisted of gemcitabine ( 1,000 mg/m2 ) and irinotecan ( 150 mg/m2 ) on days 1 and 15 of a 28 day cycle . Results Thirty-one patients were enrolled and 30 patients received protocol treatment ( 10 had refractory disease and 20 had sensitive disease ) . The median age was 64 years , and the median performance status was one . An objective response was obtained in 36.7 % ( 95 % CI : 17.3.1–56.0 % ) of the patients . The median overall survival time was 14.4 months , and the 1 year survival rate was 51 % . The chief grade 3/4 toxicities included neutropenia ( 42 % ) , thrombocytopenia ( 3 % ) , diarrhea ( 9 % ) , and liver dysfunction ( 3 % ) . The only grade 4 toxicities were one case of grade 4 neutropenia ( 3.3 % ) and one case of grade 4 thrombocytopenia ( 3.3 % ) . Conclusion Gemcitabine plus irinotecan is an active regimen that seems to be well-tolerated by patients with previously treated SCLC Background : We investigated the efficacy and safety of biweekly irinotecan and cisplatin ( IP ) as first-line treatment in advanced gastric cancer patients . Methods : Irinotecan 125 mg/m2 on day 1 and cisplatin 60 mg/m2 on day 2 were administrated every 14 days . UGT1A1 * 28/*6 and toxicities were analyzed . Results : Forty-one eligible patients were enrolled . Fifteen patients , who were defined as the high-dose group , received starting doses of irinotecan 125 mg/m2 . Twenty-six patients , who were defined as the low-dose group , received starting doses of irinotecan 80 mg/m2 and cisplatin 50 mg/m2 . The response rate was 53.3 % in the irinotecan high-dose group and 53.8 % in the irinotecan low-dose group . The most common grade 3/4 toxicity was neutropenia ( 68.3 % ) . No significant difference in grade 3/4 neutropenia was found between patients with the wild-type genotype and those with variant genotypes for UGT1A1 * 28 or UGT1A1 * 6 . Conclusions : The combination of biweekly irinotecan 80 mg/m2 and cisplatin 50 mg/m2 was active and tolerable . The role of the UGT1A1 genotype in clinical toxicity of an IP regimen requires further investigation Background : To assess the efficacy and safety of individualised dose optimisation of irinotecan monotherapy as salvage treatment for advanced gastric cancer ( AGC ) . Methods : A total of 43 patients were enrolled . Intravenous irinotecan ( 350 mg m−2 ) was administered every 3 weeks . The dose was increased ( 425 mg m−2 and 500 mg m−2 ) or decreased ( 250 mg m−2 ) depending on patient tolerance . UGT1A1 genotypes were determined by direct sequencing of genomic DNA extracted from peripheral blood . Results : A total of 183 cycles of irinotecan were administered , with a median of four cycles per patient . The overall response rate was 9.3 % , and the disease control rate was 62.8 % . Median time to disease progression was 2.8 months , and median overall survival was 8.0 months . Grade 3–4 neutropenia was the most common toxicity ( 53.5 % ) , and febrile neutropenia was the least common toxicity ( 4.6 % ) . Compared with defective allele groups , UGT1A1 * 1/*1 was associated with a lower incidence of grade 3–4 neutropenia during the first cycle ( P=0.018 ) . Conclusion : Individualised irinotecan dose escalation based on patient tolerance was not associated with increased toxicity and shows modest activity as salvage chemotherapy for AGC . The role of UGT1A1 genotype in clinical toxicity requires further evaluation Irinotecan‐induced severe neutropenia is associated with homozygosity for the UGT1A1 * 28 or UGT1A1 * 6 alleles . In this study , we determined the maximum‐tolerated dose ( MTD ) of irinotecan in patients with UGT1A1 polymorphisms . Patients who had received chemotherapy other than irinotecan for metastatic gastrointestinal cancer were enrolled . Patients were divided into three groups according to UGT1A1 genotypes : wild‐type ( * 1/*1 ) ; heterozygous ( * 28/*1 , * 6/*1 ) ; or homozygous ( * 28/*28 , * 6/*6 , * 28/*6 ) . Irinotecan was given every 2 weeks for two cycles . The wild‐type group received a fixed dose of irinotecan ( 150 mg/m2 ) to serve as a reference . The MTD was guided from 75 to 150 mg/m2 by the continual re assessment method in the heterozygous and homozygous groups . Dose‐limiting toxicity ( DLT ) and pharmacokinetics were evaluated during cycle 1 . Of 82 patients enrolled , DLT was assessable in 79 patients ( wild‐type , 40 ; heterozygous , 20 ; and homozygous , 19 ) . Dose‐limiting toxicity occurred in one patient in the wild‐type group , none in the heterozygous group , and six patients ( grade 4 neutropenia ) in the homozygous group . In the homozygous group , the MTD was 150 mg/m2 and the probability of DLT was 37.4 % . The second cycle was delayed because of neutropenia in 56.3 % of the patients given the MTD . The AUC0–24 h of SN‐38 was significantly greater ( P < 0.001 ) and more widely distributed in the homozygous group . Patients homozygous for the UGT1A1 * 28 or UGT1A1 * 6 allele can receive irinotecan in a starting dose of 150 mg/m2 , but many required dose reductions or delayed treatment in subsequent cycles . UMIN Clinical Trial Registration number : UMIN000000618 . ( Cancer Sci 2011 ; 102 : 1868–1873 Introduction : Paclitaxel plus carboplatin ( TC ) is generally considered to be the \" gold st and ard \" regimen for treatment of epithelial ovarian carcinomas . Little data are available , however , on the use of this regimen in patients with clear cell adenocarcinoma of the ovary ( CCC ) . Combination chemotherapy with irinotecan hydrochloride plus cisplatin has been reported to be effective for primary and recurrent or resistant CCC . We compared these 2 combinations in patients with CCC . Methods : Patients ( \n Output:\n " }, { "from": "agent", "value": "In conclusion , in this meta- analysis , the UGT1A1 * 6 polymorphisms were associated with an increased risk of IRI-induced neutropenia in cancer patients , and increased incidences of severe neutropenia could be correlated with diverse regions , cancer type , low dose of IRI and the duration of treatment" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: PURPOSE To evaluate quality of life ( QoL ) , an important outcome owing to poor long-term survival , after stereotactic body radiation therapy ( SBRT ) to the liver . METHODS AND MATERIAL S Patients ( n=222 ) with hepatocellular carcinoma ( HCC ) , liver metastases , or intrahepatic cholangiocarcinoma and Child-Pugh A liver function received 24 - 60 Gy of 6-fraction image-guided SBRT . Prospect i ve QoL assessment was completed with the European Organization for Research and Treatment of Cancer Quality of Life Question naire Core-30 ( QLQ-C30 ) and /or Functional Assessment of Cancer Therapy-Hepatobiliary ( FACT-Hep , version 4 ) question naires at baseline and 1 , 3 , 6 , and 12 months after treatment . Ten HCC patients with Child-Pugh B liver function were also treated . RESULTS The QLQ-C30 was available for 205 patients , and 196 completed the FACT-Hep . No difference in baseline QoL ( P = .17 ) or overall survival ( P = .088 ) was seen between the HCC , liver metastases , and intrahepatic cholangiocarcinoma patients . Appetite loss and fatigue measured by the QLQ-C30 clinical ly and statistically worsened by 1 month after treatment but recovered by 3 months . At 3 and 12 months after treatment , respectively , the FACT-Hep score had improved relative to baseline in 13%/19 % , worsened in 36%/27 % , and remained stable in 51%/54 % . Using the QLQ-C30 Global Health score , QoL improved in 16%/23 % , worsened in 34%/39 % , and remained stable in 50%/38 % at 3 and 12 months , respectively . Median survival was 17.0 months ( 95 % confidence interval [ CI ] 12.3 - 19.8 months ) . Higher baseline scores on both FACT-Hep and QLQ-C30 Global Health were associated with improved survival . Hazard ratios for death , per 10-unit decrease in QoL , were 0.90 ( 95 % CI 0.83 - 0.98 ; P = .001 ) and 0.88 ( 95 % CI 0.82 - 0.95 ; P = .001 ) , respectively . Tumor size was inversely correlated with survival . CONCLUSIONS Liver SBRT temporarily worsens appetite and fatigue , but not overall QoL. Stereotactic body radiation therapy is well tolerated and warrants comparison against other liver-directed therapies PURPOSE We performed a Phase I dose-escalation study to explore the feasibility and safety of treating primary and metastatic liver tumors with single-fraction stereotactic body radiotherapy ( SBRT ) . METHODS AND MATERIAL S Between February 2004 and February 2008 , 26 patients were treated for 40 identifiable lesions . Nineteen patients had hepatic metastases , 5 had intrahepatic cholangiocarcinomas , and 2 had recurrent hepatocellular carcinomas . The prescribed radiation dose was escalated from 18 to 30 Gy at 4-Gy increments with a planned maximum dose of 30 Gy . Cumulative incidence functions accounted for competing risks to estimate local failure ( LF ) incidence over time under the competing risk of death . RESULTS All patients tolerated the single-fraction SBRT well without developing a dose-limiting toxicity . Nine acute Grade 1 toxicities , one acute Grade 2 toxicity , and two late Grade 2 gastrointestinal toxicities were observed . After a median of 17 months follow-up ( range , 2 - 55 months ) , the cumulative risk of LF at 12 months was 23 % . Fifteen patients have died : 11 treated for liver metastases and 4 with primary liver tumors died . The median survival was 28.6 months , and the 2-year actuarial overall survival was 50.4 % . CONCLUSIONS It is feasible and safe to deliver single-fraction , high-dose SBRT to primary or metastatic liver malignancies measuring ≤5 cm . Moreover , single-fraction SBRT for liver lesions demonstrated promising local tumor control with minimal acute and long-term toxicity . Single-fraction SBRT appears to be a viable nonsurgical option , but further studies are warranted to evaluate both control rates and impact on quality of life BACKGROUND & AIMS Quality of life ( QoL ) is an important aspect of any palliative treatment . However , few data are available from studies comparing how embolotherapy affects QoL for patients with hepatocellular carcinoma ( HCC ) . We performed a health-related QoL study in patients with HCC treated by transarterial chemoembolization ( TACE ) or (90)Y radioembolization . METHODS We performed a prospect i ve study of patients undergoing (90)Y radioembolization ( n = 29 ) or TACE ( n = 27 ) for HCC . We assessed patients before treatment and 2 and 4 weeks after treatment using the Functional Assessment of Cancer Therapy-Hepatobiliary ( FACT-Hep ) survey . We compared differences in health-related QoL between the treatment groups using linear regression repeated- measures analysis . RESULTS At baseline , the groups had comparable baseline Child-Pugh class and performance statuses , although patients undergoing TACE had lower tumor burdens ( P = .018 ) and less-advanced disease , based on United Network for Organ Sharing and Barcelona stage ( P = .03 and P = .02 , respectively ) , permitting injections at segmental arteries ( P < .0001 ) . There were no significant differences between groups in overall FACT-Hep health-related QoL scores ( P = .055 , effect size [ ES ] , .54 ) , owing to a limited sample size . Despite the more advanced disease of patients who received (90)Y radioembolization , they had a significantly better QoL , based on social well being ( P = .019 ; ES , .65 ) , functional well-being ( P = .031 ; ES , .60 ) , and embolotherapy-specific scores ( P = .018 ; ES , .67 ) . They also had a trend toward better overall QoL ( P = .055 ; ES , .54 ) and higher Trial Outcome Index ( P = .05 ; ES , .56 ) and FACT-Hep scores ( P = .071 ; ES , .52 ) . CONCLUSIONS In a prospect i ve study , although (90)Y radioembolization was used to treat patients with more advanced disease , those who received this treatment had significant increases in several features of QoL , whereas patients who received TACE had decreases in QoL scores . However , because of the limited sample size , there was no significant difference in overall FACT-Hep health-related QoL scores . The increase was greatest in the embolotherapy-specific score . Clinical Trials.gov , number NCT00739167 \n Output:\n " }, { "from": "agent", "value": "Despite this there were few statistically significant declines in QOL scores following SABR .\nAll studies showed no significant QOL decline in any domain at their respective endpoints .\nConclusion Results of this systematic review demonstrate well-preserved post liver SABR QOL ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Introduction Many intensive care patients experience sleep disruption potentially related tonoise , light and treatment interventions . The purpose of this study was tocharacterise , in terms of quantity and quality , the sleep of intensive care patients , taking into account the impact of environmental factors . Methods This observational study was conducted in the adult ICU of a tertiary referralhospital in Australia , enrolling 57 patients . Polysomnography ( PSG ) was performedover a 24-hour period to assess the quantity ( total sleep time : hh : mm ) and quality ( percentage per stage , duration of sleep episode ) of patients ' sleep while in ICU.Rechtschaffen and Kales criteria were used to categorise sleep . Interrater checkswere performed . Sound pressure and illuminance levels and care events weresimultaneously recorded . Patients reported on their sleep quality in ICU using theRichards Campbell Sleep Question naire and the Sleep in Intensive Care Question naire . Data were summarised using frequencies and proportions or measures of central tendency and dispersion as appropriate and Cohen 's Kappa statistic wasused for interrater reliability of the sleep data analysis . Results Patients ' median total sleep time was 05:00 ( IQR : 02:52 to 07:14 ) . The majority ofsleep was stage 1 and 2 ( medians : 19 and 73 % ) with scant slow wave and REM sleep . The median duration of sleep without waking was 00:03 . Sound levels were high(mean Leq 53.95 dB(A ) during the day and 50.20 dB(A ) at night ) and illuminancelevels were appropriate at night ( median < 2 lux ) but low during the day(median : 74.20 lux ) . There was a median 1.7 care events/h . Patients ' meanself-reported sleep quality was poor . Interrater reliability of sleep staging washighest for slow wave sleep and lowest for stage 1 sleep . Conclusions The quantity and quality of sleep in intensive care patients are poor and may berelated to noise , critical illness itself and treatment events that disturb sleep . The study highlights the challenge of quantifying sleep in the critical care setting and the need for alternative methods of measuring sleep . The results suggest that a sound reduction program is required and other interventions toimprove clinical practice s to promote sleep in intensive care patients .Trial registration Australian New Zeal and clinical trial registry(http://www.anzctr.org.au/ ) : ACTRN12610000688088 Introduction Environmental stimulus , especially noise and light , is thought to disrupt sleep in patients in the intensive care unit ( ICU ) . This study aim ed to determine the physiological and psychological effects of ICU noise and light , and of earplugs and eye masks , used in these conditions in healthy subjects . Methods Fourteen subjects underwent polysomnography under four conditions : adaptation , baseline , exposure to recorded ICU noise and light ( NL ) , and NL plus use of earplugs and eye masks ( NLEE ) . Urine was analyzed for melatonin and cortisol levels . Subjects rated their perceived sleep quality , anxiety levels and perception of environmental stimuli . Results Subjects had poorer perceived sleep quality , more light sleep , longer rapid eye movement ( REM ) latency , less REM sleep when exposed to simulated ICU noise and light ( P < 0.05 ) . Nocturnal melatonin ( P = 0.007 ) and cortisol secretion levels ( P = 0.004 ) differed significantly by condition but anxiety levels did not ( P = 0.06 ) . Use of earplugs and eye masks result ed in more REM time , shorter REM latency , less arousal ( P < 0.05 ) and elevated melatonin levels ( P = 0.002 ) . Conclusions Earplugs and eye masks promote sleep and hormone balance in healthy subjects exposed to simulated ICU noise and light , making their promotion in ICU patients reasonable BACKGROUND Post-anaesthesia care units ( PACUs ) with 24/7 activity and consequently artificial light and noise may disturb the sleep of patients who require prolonged medical supervision . After one postoperative night , we compared sleep quality in patients with and without noise ( earplug ) and light ( eye mask ) protection . METHODS After ethical board approval , 46 patients without any neurological or respiratory failure undergoing major non-cardiac surgery were prospect ively included . They were r and omized to sleep with or without protective devices during the first postoperative night in the PACU . Sleep quality was simultaneously measured by sleep- quality scales ( Spiegel score and Medical Outcomes Study Sleep ) , nurses ' assessment , and through a wrist actigraph ( Actiwatch ) . Secondary outcomes such as pain control and nocturnal activity were recorded . Comparisons between groups were made by Student 's t-test or non-parametric test for repeated measures as appropriate ( SPSS 10.0 ) . A P-value < 0.05 was considered significant . RESULTS Data from 41 patients were analysed . Protective devices during the first postoperative night prevented a decrease in sleep quality compared with st and ard care , as evaluated by the Spiegel scale : 20 ( 4 ) vs 15 ( 5 ) , P=0.006 . These devices significantly decreased the need for a nap [ 50 % 95 % confidence interval ( CI ) ( 20 - 80 ) vs 95 % 95 % CI ( 85 - 100 ) , P<0.001 ] , but had no effect on sleep length evaluated by Actiwatch . The total consumption of morphine was significantly reduced in the first 24 h [ respectively , 15(12 ) mg and 27(17 ) mg , P=0.02 ] . CONCLUSIONS Earplugs and eye masks applied in the PACU during the first postoperative night significantly preserve sleep quality . Such non-invasive and cheap devices may be generalized in the PACU or in intensive care units Introduction This study hypothesised that a reduction of sound during the night using earplugs could be beneficial in the prevention of intensive care delirium . Two research questions were formulated . First , does the use of earplugs during the night reduce the onset of delirium or confusion in the ICU ? Second , does the use of earplugs during the night improve the quality of sleep in the ICU ? Methods A r and omized clinical trial included adult intensive care patients in an intervention group of 69 patients sleeping with earplugs during the night and a control group of 67 patients sleeping without earplugs during the night . The research ers were blinded during data collection . Assignment was performed by an independent nurse research er using a computer program . Eligible patients had an expected length of stay in the ICU of more than 24 hours , were Dutch- or English-speaking and scored a minimum Glasgow Coma Scale of 10 . Delirium was assessed using the vali date d NEECHAM scale , sleep perception was reported by the patient in response to five questions . Results The use of earplugs during the night lowered the incidence of confusion in the studied intensive care patients . A vast improvement was shown by a Hazard Ratio of 0.47 ( 95 % confidence interval ( CI ) 0.27 to 0.82 ) . Also , patients sleeping with earplugs developed confusion later than the patients sleeping without earplugs . After the first night in the ICU , patients sleeping with earplugs reported a better sleep perception . Conclusions Earplugs may be a useful instrument in the prevention of confusion or delirium . The beneficial effects seem to be strongest within 48 hours after admission . The relation between sleep , sound and delirium , however , needs further research .Trial registration Current Controlled Trials IS RCT Objectives : To determine the relationship between the number of delirium days experienced by intensive care patients and mortality , ventilation time , and intensive care unit stay . Design : Prospect i ve cohort analysis . Setting : Patients from 68 intensive care units in five countries . Patients : Three hundred fifty-four medical and surgical intensive care patients enrolled in the SEDCOM ( Safety and Efficacy of Dexmedetomidine Compared with Midazolam ) trial received a sedative study drug and completed at least one delirium assessment . Interventions : Sedative drug interruption and /or titration to maintain light sedation with daily arousal and delirium assessment s up to 30 days of mechanical ventilation . Measurements and Main Results : The primary outcome was all-cause 30-day mortality . Multivariable analysis using Cox regression incorporating delirium duration as a time-dependent variable and adjusting for eight relevant baseline covariates was conducted to quantify the relationship between number of delirium days and the three main outcomes . Overall , delirium was diagnosed in 228 of 354 patients ( 64.4 % ) . Mortality was significantly lower in patients without delirium compared to those with delirium ( 15 of 126 [ 11.9 % ] vs. 69 of 228 [ 30.3 % ] ; p < .001 ) . Similarly , the median time to extubation and intensive care unit discharge were significantly shorter among nondelirious patients ( 3.6 vs. 10.7 days [ p < .001 ] and 4 vs. 16 days [ p < .001 ] , respectively ) . In multivariable analysis , the duration of delirium exhibited a nonlinear relationship with mortality ( p = .02 ) , with the strongest association observed in the early days of delirium . In comparison to 0 days of delirium , an independent dose-response increase in mortality was observed , which increased from 1 day of delirium ( hazard ratio , 1.70 ; 95 % confidence interval , 1.27–2.29 ; p < .001 ) , 2 days of delirium ( hazard ratio , 2.69 ; confidence interval , 1.58–4.57 ; p < .001 ) , and ≥3 days of delirium ( hazard ratio , 3.37 ; confidence interval , 1.92–7.23 ; p < .001 ) . Similar independent relationships were observed between delirium duration and ventilation time and intensive care length of stay . Conclusions : In ventilated and lightly se date d intensive care unit patients , the duration of delirium was the strongest independent predictor of death , ventilation time , and intensive care unit stay after adjusting for relevant covariates Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Rationale Delirium incidence in intensive care unit ( ICU ) patients is high and associated with poor outcome . Identification of high-risk patients may facilitate its prevention . Purpose To develop and vali date a model based on data available at ICU admission to predict delirium development during a patient ’s complete ICU stay and to determine the predictive value of this model in relation to the time of delirium development . Methods Prospect i ve cohort study in 13 ICUs from seven countries . Multiple logistic regression analysis was used to develop the early prediction ( E-PRE-DELIRIC ) model on data of the first two-thirds and vali date d on data of the last one-third of the patients from every participating ICU . Results In total , 2914 patients were included . Delirium incidence was 23.6 % . The E-PRE-DELIRIC model consists of nine predictors assessed at ICU admission : age , history of cognitive impairment , history of alcohol abuse , blood urea nitrogen , admission category , urgent admission , mean arterial blood pressure , use of corticosteroids , and respiratory failure . The area under the receiver operating characteristic curve ( AUROC ) was 0.76 [ 95 % confidence interval ( CI ) 0.73–0.77 ] in the development data set and 0.75 ( 95 % CI 0.71–0.79 ) in the validation data set . The model was well calibrated . AUROC increased from 0.70 ( 95 % CI 0.67–0.74 ) , for delirium that developed < 2 days , to 0.81 ( 95 % CI 0.78–0.84 ) , for delirium that developed > 6 days . Conclusion Patients ’ delirium risk for the complete ICU length of stay can be predicted at admission using the E-PRE-DELIRIC model , allowing early preventive interventions aim ed to reduce incidence and severity of ICU delirium Purpose : Sleep deprivation may be particularly detrimental to intensive care unit ( ICU ) patients . Polysomnography has demonstrated abnormal sleep in medical and surgical ICU population s. Both environmental factors and circadian disruption have been implicated . We hypothesized that patients in a neurologic ICU would demonstrate similar sleep disturbances and that a combination of sleep-promoting interventions would increase sleep time . Methods : Twelve patients were enrolled in this pilot-r and omized , controlled , study in a neurologic ICU . For adult patients undergoing continuous EEG for clinical purpose s , noise-cancelling headphones and eye masks were worn , and an oral dose of melatonin was administered for 3 days , or until EEG was stopped . Sleep was scored according to st and ard criteria ; EEG was characterized and analyzed quantitatively . Results : Sixty-five percent of the patients ' recordings were unscorable based on accepted st and ardized criteria ; therefore , sleep measures could not be compared . For those with sleep that could be scored , total sleep time was normal , although sleep was fragmented and time spent in slow-wave or rapid eye movement sleep was notably decreased . Patients with unscorable recordings had worse injury severity measures , absent or significantly slower posterior dominant rhythm , and less coherence of posterior faster frequencies . Clinical outcomes were similar between intervention and control groups . Conclusions : Although sleep-promoting interventions were feasible , sleep quantification based on currently accepted criteria limited the ability to score sleep . Similar to other ICUs , sleep in \n Output:\n " }, { "from": "agent", "value": "Placement of earplugs in patients admitted to the ICU , either in isolation or as part of a bundle of sleep hygiene improvement , is associated with a significant reduction in risk of delirium ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Pain on injection is a recognized adverse event ( AE ) of propofol administration for the induction of general anesthesia . Preceded by venous occlusion , flurbiprofen axetil , a prodrug of the NSAID flurbiprofen , has been associated with a reduction in pain induced by propofol injection . A review of the literature determined that no published data were available on the influence of age on the requirements for flurbiprofen axetil dose . OBJECTIVE This study was undertaken to examine the influence of age on flurbiprofen axetil requirements for the treatment of propofol-induced pain on injection in Japanese adult surgical patients . METHODS This prospect i ve , r and omized , double-blind , vehicle-controlled , parallel-group , dose-ranging study was conducted at the Department of Anesthesiology , Institute of Clinical Medicine , University of Tsukuba , Tsukuba , Japan . Young ( age 20 - 40 years ) and older ( age 60 - 80 years ) Japanese patients scheduled for various types of surgery ( eg , cholecystectomy ) were eligible . Patients were r and omized to receive flurbiprofen axetil at 1 of 2 doses ( 25 or 50 mg , regardless of body weight ) or inactive vehicle ( saline ) , preceded by manual venous occlusion with a rubber tourniquet for 2 minutes and followed by the infusion of the first 25 % of calculated propofol dose ( 0.5 mg/kg at room temperature , 23 degrees C ) into the largest dorsal vein of the h and through a 20-G IV cannula ( without local anesthesia ) , followed by the release of the occlusion and delivery of propofol 2 mg/kg . An investigator blinded to treatment question ed each patient about pain intensity during propofol injection which was assessed using a verbal rating scale : 0 = none ; 1 = mild ; 2 = moderate ; and 3 = severe . The overall prevalence of pain was calculated in each group . AEs at the injection site ( pain , edema , wheal , inflammation ) were assessed by the study investigator for 24 hours after surgery using spontaneous reporting and patient interview . RESULTS A total of 150 patients , 75 young adults ( 38 men , 37 women ; mean [ SD ] age , 31 [ 5 ] years ; mean [ SD ] height , 163 [ 7 ] cm ; mean [ SD ] body weight , 58 [ 9 ] kg ) and 75 older adults ( 38 men , 37 women ; mean [ SD ] age , 70 [ 6 ] years ; mean [ SD ] height , 154 [ 8 ] cm ; mean [ SD ] body weight , 53 [ 10 ] kg ) , were enrolled . Each treatment group comprised 25 patients . No differences in demographic characteristics were observed among the 3 study groups . In young patients , the overall prevalence of propofol-induced pain was significantly lower in patients who received flurbiprofen axetil 50 mg ( 12 [ 48 % ] ) compared with that in patients who received flurbiprofen axetil 25 mg ( 20 [ 80 % ] ) or vehicle ( 22 [ 88 % ] ) ( P < 0.05 and P < 0.01 , respectively ) . The median pain intensity score was significantly lower in patients who received flurbiprofen axetil 50 mg ( 0 ) compared with that in patients who received flurbiprofen axetil 25 mg ( 1 ) or vehicle ( 2 ) ( P < 0.05 and P < 0.01 , respectively ) . In older patients , the overall prevalences of pain on propofol injection were 9 ( 36 % ) in the flurbiprofen axetil 50-mg group and 11 ( 44 % ) in the flurbiprofen axetil 25-mg group compared with 21 ( 84 % ) in the vehicle group ( both , P < 0.01 ) . The median pain score was significantly lower in patients who received flurbiprofen 50 mg ( 0 ) or 25 mg ( 0 ) than in those who received vehicle ( 1 ) ( both , P < 0.01 ) . All treatments were well tolerated . CONCLUSIONS In this small clinical trial in Japanese surgical patients undergoing general anesthesia , flurbiprofen axetil requirements for the reduction of pain during injection of propofol were found to be 50 mg in young adults ( age 20 - 40 years ) and 25 or 50 mg in older adults ( age 60 - 80 years ) , regardless of weight , preceded by venous occlusion for 2 minutes Purpose To examine the analgesic effect of preoperative administration of flurbiprofen axetil and that of postoperative administration of a combination of flurbiprofen axetil and fentanyl , as well as perioperative plasma β-endorphin ( β-EP ) levels in patients undergoing esophagectomy . Methods Forty-five patients were r and omly divided into three groups : group A : 100 mg flurbiprofen axetil preoperative , 10 μg/kg fentanyl + 10 ml placebo postoperative ; group B : 100 mg flurbiprofen axetil preoperative , 10 μg/kg fentanyl + 100 mg flurbiprofen axetil postoperative ; group C : 10 ml placebo preoperative , 10 μg/kg fentanyl + 10 ml placebo postoperative . Postoperative analgesia was achieved by intravenous infusion containing flurbiprofen axetil and /or fentanyl at 2.0 ml/h ( total volume , 100 ml ) using infusion pumps . The β-EP was measured at preanesthesia ( T1 ) , the end of surgery ( T2 ) , 24 h ( T3 ) , and 48 h ( T4 ) after surgery . Visual analog scale scores ( VAS ) at T3 , T4 ( at rest ) , and rescue analgesic tramadol requirement was recorded . Results The VAS of group B was significantly lower than group A and C ( P < 0.01 ) at T3 and T4 . The β-EP levels at T2–T4 in group A did not differ significantly from those at T1 ( P > 0.05 ) ; however , the β-EP levels in group B at T3–T4 increased significantly ( P < 0.05 ) , while those in group C increased at T2 and decreased at T4 ( P < 0.05 ) . The β-EP levels in group B at T3 and T4 were the highest as compared to its levels in groups A and C ( P < 0.01 ) . Tramadol consumption in group B was significantly lower than in groups A and C ( P < 0.01 ) . Conclusion These results show that flurbiprofen axetil enhances the analgesic effect of fentanyl associated with increase in β-EP levels BACKGROUND Pain on injection is a recognized adverse event ( AE ) of propofol administration for the induction of general anesthesia . Pretreatment with lidocaine , metoclopramide , or flurbiprofen axetil has been reported to be effective in reducing propofol-induced pain . However , no studies comparing the efficacy of these 3 drugs for preventing pain on injection of propofol have been identified . OBJECTIVE The aim of this study was to compare the efficacy of lidocaine , metoclopramide , and flurbiprofen axetil for reducing pain on injection of propofol in Japanese adult surgical patients . METHODS This prospect i ve , r and omized , double-blind , parallel-group , placebo-controlled study was conducted at the Department of Anesthesiology , Ushiku Aiwa General Hospital , Ibaraki , Japan . Japanese patients scheduled to undergo elective surgery were eligible for inclusion in the study . Patients were r and omized into 4 groups to receive IV lidocaine 40 mg , metoclopramide 10 mg , flurbiprofen axetil 50 mg , or placebo ( saline ) , preceded by venous occlusion with a rubber tourniquet for 2 minutes , and followed by the administration of propofol 0.5 mg/kg into the largest vein of the h and through a 20-gauge IV cannula . Immediately after the administration of propofol , an investigator blinded to treatment interviewed each patient on injection-site pain . Responses were scored on a 4-point verbal rating scale ( 0 = none , 1 = mild pain , 2 = moderate pain , and 3 = severe pain ) . Incidence and intensity of pain ( as assessed by mean pain scores ) were determined in each of the 4 study groups . AEs at the injection site ( eg , pain , edema , wheal , inflammation ) , extrapyramidal disturbance , and symptoms or signs associated with gastrointestinal ( GI ) ulceration were assessed by the study investigator for 24 hours following surgery using spontaneous reporting and patient interview . RESULTS A total of 100 patients ( 54 women , 46 men ) aged 22 to 65 years were enrolled in the study . The patients ' mean ( SD ) age was 42 ( 12 ) years . Their mean ( SD ) height was 161 ( 8) cm and their mean ( SD ) weight was 59 ( 9 ) kg . Each treatment group comprised 25 patients . There were no significant differences in demographic characteristics between treatment groups . The overall incidence of propofol-induced pain was 24 % ( 6/25 patients ) with lidocaine ( P = 0.001 ) , 28 % ( 7/25 patients ) with metoclopramide ( P = 0.001 ) , and 36 % ( 9/25 patients ) with flurbiprofen axetil ( P = 0.001 ) , compared with placebo ( 92 % , [ 23/25 patients ] ) . The median pain score was less in patients who had received lidocaine ( 0 ) , metoclopramide ( 0 ) , or flurbiprofen axetil ( 0 ) than in those who received placebo ( 2 ) ( all , P = 0.001 ) . The incidence and severity of such pain were not significantly different between the lidocaine- , metoclopramide- , and flurbiprofen axetil-treated groups . There were no reported injection-site AEs , extrapyramidal disturbance , or symptoms or signs associated with GI ulceration observed . CONCLUSIONS In this study of Japanese adult surgical patients , lidocaine 40 mg , metoclopramide 10 mg , and flurbiprofen axetil 50 mg , preceded by venous occlusion for 2 minutes , were effective in reducing pain during the injection of propofol . The analgesic efficacy of these 3 drugs was comparable for minimizing such pain OBJECTIVE To explore whether perioperative intravenous flurbiprofen axetil can reduce the incidence and intensity of chronic pain for breast cancer after surgical treatment . METHODS This r and omized , double-blind , controlled trial enrolled 60 patients undergoing mastectomy and axillary lymph node dissection under general anesthesia . All patients accepted Hospital Anxiety and Depression Scale ( HAD ) tests the day before the surgery to evaluate depression and anxiety . The patients were r and omly assigned to receive either 50 mg flurbiprofen axetil intravenously 15 minutes before the surgical incision and 6 hours later ( group F ) or intravenous 5 mL intralipid as a control ( group C ) . All patients received patient-controlled intravenous analgesia ( PCIA ) with fentanyl postoperatively . Peripheral venous blood sample s were drawn before the surgery , at 4 and 24 h after the surgery to detect the plasma level of PGE2 and tumor necrosis factor-α ( TNF-α ) . Postoperative fentanyl consumption , Numerical Rating Scale ( NRS ) scores and adverse effects were recorded at 2 , 6 , 12 , 24 and 48 h after the surgery . The duration and intensity of pain were followed up by telephone at the 2nd-12th month after the surgery . RESULTS The incidence of pain at 2 , 4 , 6 , and 12 months after the breast surgery was 33 % , 20 % , 15 % , and 10 % , respectively , and the average pain score was 0.77 , 0.57 , 0.28 , and 0.18 , respectively . Compared with group C , the scores of pain in group F were significantly lower at 2 , 4 , 6 and 12 months postoperatively ( F=7.758 , P=0.007 ) . The incidence of pain in group F was significantly lower at 2 , 4 and 6 months postoperatively ( P<0.05 ) . There was no significant difference in the incidence of pain between the groups at 12 months postoperatively ( P>0.05 ) . Preoperatively and at 4 and 24 h after the surgery , there was no significant difference in the level of TNF-α between the two groups ( F=0.530 , P=0.470 ) ; but plasma concentration of PGE2 in group F was significantly lower than that in group C ( F=5.646 , P=0.021 ) . No patients developed abnormal bleeding , peptic ulcer , impaired liver or renal function and respiratory depression . CONCLUSION Perioperative intravenous infusion of 100 mg flurbiprofen axetil can decrease the intensity and incidence of chronic pain for breast cancer after surgical treatment Background A microemulsion propofol causes a high incidence of pain during intravenous injection . \n Output:\n " }, { "from": "agent", "value": "In terms of drug safety , there were no adverse effects ( AEs ) reported between flurbiprofen axetil-based regimens and placebo regimens .\nFlurbiprofen axetil , an injectable prodrug of flurbiprofen , can significantly prevent or relieve the pain induced by propofol injection ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background : The use of administrative data bases to perform epidemiological studies in asthma has increased in recent years . The absence of clinical parameters to measure the level of asthma severity and control is a major limitation of data base studies . A study was undertaken to develop and vali date two data base indexes to measure the control and severity of asthma . Methods : Data base indexes of asthma severity and control were derived from definitions in the Canadian Asthma Consensus Guidelines based on dispensed prescriptions and on medical services recorded in two large administrative data bases from the Canadian province of Québec ( Régie de l’Assurance Maladie du Québec ( RAMQ ) and MED-ECHO ) over 12 months . The data base indexes of asthma severity and control were vali date d against the pulmonary function test results of 71 patients with asthma r and omly selected from two asthma clinics , and they were also applied to a cohort of patients with asthma followed up for 139 283 person-years selected from the RAMQ and MED-ECHO data bases between 1 January 1997 and 31 December 2004 . Results : According to the data base indexes , 49.3 % , 29.6 % and 21.1 % of patients recruited at the asthma clinics were found to have mild , moderate and severe asthma , respectively , while 53.5 % were found to have controlled asthma . The mean predicted value of the forced expiratory volume in 1 s ( FEV1 ) ranged from 89.8 % for mild asthma to 61.5 % for severe asthma ( p<0.001 ) , whereas the range from controlled to uncontrolled asthma was 89.5 % to 67.3 % ( p<0.001 ) . The ratio of the FEV1 to the forced vital capacity ( FEV1/FVC ratio ) measured in 56 patients ranged from 75.8 % for mild asthma to 61.8 % for severe asthma ( p = 0.030 ) , whereas the range from controlled to uncontrolled asthma was 75.3 % to 65.7 % ( p<0.001 ) . Conclusion : In the absence of clinical data , these data base indexes could be used in epidemiological studies to assess the severity and control of asthma BACKGROUND Isl and and mainl and Puerto Rican children have the highest rates of asthma and asthma morbidity of any ethnic group in the United States . OBJECTIVE We evaluated the effectiveness of a culturally adapted family asthma management intervention called CALMA ( an acronym of the Spanish for \" Take Control , Empower Yourself and Achieve Management of Asthma \" ) in reducing asthma morbidity in poor Puerto Rican children with asthma . METHODS Low-income children with persistent asthma were selected from a national health plan insurance cl aims data base by using a computerized algorithm . After baseline , families were r and omly assigned to either the intervention or a control group . RESULTS No significant differences between control and intervention group were found for the primary outcome of symptom-free days . However , children in the CALMA intervention group had 6.5 % more symptom-free nights , were 3 times more likely to have their asthma under control , and were less likely to visit the emergency department and be hospitalized as compared to the control group . Caregivers receiving CALMA were significantly less likely to feel helpless , frustrated , or upset because of their child 's asthma and more likely to feel confident to manage their child 's asthma . CONCLUSION A home-based asthma intervention program tailored to the cultural needs of low income Puerto Rican families is a promising intervention for reducing asthma morbidity Our objective was to vali date the Council of State and Territorial Epidemiologists ( CSTE ) definition of \" probable \" asthma and the Health Plan Employer Data and Information Set ( HEDIS ) definition of persistent asthma for diagnosis of pediatric asthma , and examine modifications that improve case recognition . CSTE and HEDIS criteria were applied to a cross-sectional study of 3,905 Medicaid children with physician-confirmed diagnosis of asthma/no asthma using a vali date d survey instrument based upon National Asthma Education and Prevention Program ( NAEPP ) Guidelines . Modified criteria were applied to another group of 1,458 non-Medicaid children from a managed care organization ( MCO ) . Of 1,852 Medicaid children with physician-confirmed asthma , 906 had persistent asthma . CSTE identified 61 % of children with \" probable \" asthma ; HEDIS identified 44 % of children with persistent asthma . Correct identification increased with greater disease severity . A modified CSTE increased sensitivity from 0.61 to 0.90 , while maintaining high specificity . Three new HEDIS algorithms increased sensitivity from 0.44 to > 0.84 , with specificity > 0.89 . When applied prospect ively to MCO children , these new algorithms demonstrated improved sensitivity . In conclusion , studies using current CSTE or HEDIS algorithms for case recognition underestimate asthma prevalence and overestimate asthma severity in children . Modified algorithms improve the identification of \" probable \" and persistent asthma OBJECTIVE To assess the practice -level effects of ( 1 ) a physician peer leader intervention and ( 2 ) peer leaders in combination with the introduction of asthma education nurses to facilitate care improvement . And , to compare findings with previously reported patient-level outcomes of trial enrollees . STUDY SETTING Data were included on children 5 - 17 years old with asthma in 40 primary care practice s , affiliated with managed health care plans enrolled in the Pediatric Asthma Care Patient Outcomes Research Team ( PORT ) r and omized trial . STUDY DESIGN Primary care practice s were r and omly assigned to one of two care improvement arms or to usual care . Automated cl aims data were analyzed for 12-month periods using a repeated cross-sectional design . The primary outcome was evidence of at least one controller medication dispensed among patients with persistent asthma . Secondary outcomes included controller dispensing among all identified asthmatics , evidence of chronic controller use , and the dispensing of oral steroids . Health service utilization outcomes included numbers of ambulatory visits and hospital-based events . PRINCIPAL FINDINGS The proportion of children with persistent asthma prescribed controllers increased in all study arms . No effect of the interventions on the proportion receiving controllers was detected ( peer leader intervention effect 0.01 , 95 percent confidence interval [ CI ] : -0.07 , 0.08 ; planned care intervention effect -0.03 , 95 percent CI : -0.09 , 0.02 ) . A statistical trend was seen toward an increased number of oral corticosteroid bursts dispensed in intervention practice s. Significant adjusted increases in ambulatory visits of 0.08 - 0.10 visits per child per year were seen in the first intervention year , but only a statistical trend in these outcomes persisted into the second year of follow-up . No differences in hospital-based events were detected . CONCLUSIONS This analysis showed a slight increase in ambulatory asthma visits as a result of asthma care improvement interventions , using automated data . The absence of detectable impact on medication use at the practice level differs from the positive intervention effect observed in patient self-reported data from trial enrollees . Analysis of automated data on nonenrollees adds information about practice -level impact of care improvement strategies . Benefits of practice -level interventions may accrue disproportionately to the subgroup of trial enrollees . The effect of such interventions may be less apparent at the level of practice s or health plans Objective . Although the Health Plan Employer Data Information Set ( HEDIS ) is a common method for evaluating the quality of asthma care , its accuracy in characterizing persistent asthma in children is unknown . The objective of this study was to compare the assessment of asthma severity ( persistent vs nonpersistent asthma ) using the HEDIS criteria versus clinical criteria using National Heart , Lung , and Blood Institute ( NHLBI ) guidelines . Methods . In a cross-sectional study , we analyzed baseline data from interviews with the parents of 896 children who had asthma and participated in a r and omized controlled trial . Patients had an active clinical diagnosis of asthma , were between 2 and 12 years of age , and had no other pulmonary diseases . Patients had persistent asthma by parent report according to the HEDIS criteria when , within the last year , they had 1 asthma inpatient admission or emergency department visit or 4 asthma medication dispensing events , or 4 outpatient asthma visits and at least 2 asthma medication dispensing events . Patients had persistent asthma by parent report according to the NHLBI criteria when , within the last 2 months , they had nighttime asthma symptoms > 2 nights/mo or daytime asthma symptoms > 2 days/wk . We calculated the sensitivity of each HEDIS criterion , separately and then combined , using the NHLBI criteria as a gold st and ard . Results . On the basis of HEDIS criteria , 656 ( 73 % ) patients had persistent asthma , compared with 338 ( 38 % ) using NHLBI criteria . Although the HEDIS criteria for persistent asthma were fairly sensitive ( 0.89 ) , they were not very specific ( 0.70 ) . For children without daily controller medications ( n = 346 ) , the sensitivity was even lower ( 0.45 ) , but the specificity was similar ( 0.68 ) . We found that the test characteristics were fairly consistent across different age group strata ( 2–4 , 5–9 , and 10–12 years of age ) . Conclusions . HEDIS criteria used to determine the quality of asthma care should be interpreted with caution . Although the criteria for persistent disease — used to determine which children require daily controller medications — are fairly sensitive , they are not very specific and include children who may not require such medications Introduction Asthma is associated with a substantial economic burden on the German Statutory Health Insurance . Aims and objectives To determine costs and re source utilization associated with asthma and to analyze the impact of disease severity on subgroups based on age and gender . Methods A cl aims data base analysis from the statutory health insurance perspective was conducted . Patients with an ICD-10-GM code of asthma were extracted from a 10 % sample of a large German sickness fund . Five controls for each asthma patient matched by age and gender were r and omly selected from the same data base . Costs and re source utilization were calculated for each individual in the asthma and control group . Incremental asthma-related costs were calculated as the mean cost difference . Based on prescribed asthma medication , patients were classified as intermittent or persistent . In addition , age groups of ≤5 , 6–18 , and > 18 years were analyzed separately and gender differences were investigated . Results Overall , 49,668 individuals were included in the asthma group . On average , total annual costs per patient were € 753 higher ( p = 0.000 ) compared to the control group ( € 2,168 vs. € 1,415 ) . Asthma patients had significantly higher ( p = 0.000 ) outpatient ( € 217 ) , inpatient ( € 176 ) , and pharmacy costs ( € 259 ) . Incremental asthma-related total costs were higher for patients with persistent asthma compared to patients with intermittent asthma ( € 1,091 vs. € 408 ) . Women aged > 18 years with persistent asthma had the highest difference in costs compared to their controls ( € 1,207 ; p < 0.0001 ) . Corresponding healthcare re source utilization was significantly higher in the asthma group ( p = 0.000 ) . Conclusions The treatment of asthma is associated with an increased level of healthcare re source utilization and significantly higher healthcare costs . Asthma imposes a substantial economic burden on sickness funds BACKGROUND The risk of invasive pneumococcal disease among persons with asthma is unknown . METHODS We conducted a nested case-control study to examine the association between asthma and invasive pneumococcal disease . The study population included persons 2 to 49 years of age who were enrolled in Tennessee 's Medicaid program ( TennCare ) for more than one year during the study period ( 1995 through 2002 ) and who resided in counties participating in a prospect i ve laboratory-based program of surveillance for invasive pneumococcal disease . For each subject with invasive pneumococcal disease , 10 age-matched controls without invasive pneumococcal disease were r and omly selected from the same population . TennCare files were queried to identify the presence of coexisting conditions that confer a high risk of pneumococcal disease . For the purpose of our study , asthma was defined by documentation of one or more inpatient or emergency-department diagnoses of asthma , two outpatient diagnoses , or the use of asthma-related medications . High-risk asthma was defined as asthma requiring admission to a hospital or a visit to an emergency department , the use of rescue therapy or long-term use of oral corticosteroids , or the dispensing of three or more prescriptions for beta-agonists within the year before enrollment in the study . RESULTS A total of 635 persons with invasive pneumococcal disease and 6350 controls were identified , of whom 114 ( 18.0 percent ) and 516 ( 8.1 percent ) , respectively , had asthma . Persons with asthma had an increased risk of invasive pneumococcal disease ( adjusted odds ratio , 2.4 ; 95 percent confidence interval , 1.9 to 3.1 ) as compared with controls . Among those without coexisting conditions , the annual incidence of invasive pneumococ \n Output:\n " }, { "from": "agent", "value": "Conclusion There is no best practice method for the categorisation of asthma severity with cl aims data .\nRather , a combination of algorithms seems to be a pragmatic approach ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background —Cigarette smoking causes endothelial dysfunction , possibly through increased oxidant stress . The enzyme xanthine oxidase produces oxidative free radicals . We tested the hypothesis that xanthine oxidase contributes to endothelial dysfunction in cigarette smokers by administering the inhibitor allopurinol . Methods and Results —Fourteen cigarette smokers ( 31±4 pack years ) and 14 age- and sex-matched healthy non-smoking control subjects participated in a single-blinded , r and omized , 2-phase crossover study . All subjects had no other risk factors for atherosclerosis . Inhibition of xanthine oxidase was achieved by a single oral dose of 600 mg of allopurinol on the day of the study . Stimulated nitric oxide endothelial responses were assessed by forearm blood flow responses to intraarterial administration of acetylcholine and bradykinin 4 to 7 hours later ; basal nitric oxide was assessed using the nitric oxide synthase inhibitor NG-monomethyl-l-arginine ( L-NMMA ) ; and nitroprusside was used to assess sensitivity to nitric oxide . Dilatation produced by acetylcholine was significantly less in smokers ( 254±57 % ) than healthy controls ( 390±55 % ) ( P = 0.009 ) . Allopurinol reversed endothelial dysfunction in smokers ( acetylcholine , 463±78 % , P = 0.001 ) without affecting responses in non-smokers ( 401±80 % ) . Bradykinin responses were also impaired in smokers ( P = 0.003 ) , and improved with allopurinol , though not significantly ( P = 0.06 ) . Responses to nitroprusside and L-NMMA were not significantly different between smokers and controls and were not altered by allopurinol . Conclusions —Smoking-induced endothelial dysfunction of resistance vessels is rapidly reversed with oral allopurinol . These data suggest that xanthine oxidase contributes importantly to endothelial dysfunction caused by cigarette smoking Background —Endothelial function is impaired in coronary artery disease and may contribute to its clinical manifestations . Increased oxidative stress has been linked to impaired endothelial function in atherosclerosis and may play a role in the pathogenesis of cardiovascular events . This study was design ed to determine whether endothelial dysfunction and vascular oxidative stress have prognostic impact on cardiovascular event rates in patients with coronary artery disease . Methods and Results —Endothelium-dependent and -independent vasodilation was determined in 281 patients with documented coronary artery disease by measuring forearm blood flow responses to acetylcholine and sodium nitroprusside using venous occlusion plethysmography . The effect of the coadministration of vitamin C ( 24 mg/min ) was assessed in a subgroup of 179 patients . Cardiovascular events , including death from cardiovascular causes , myocardial infa rct ion , ischemic stroke , coronary angioplasty , and coronary or peripheral bypass operation , were studied during a mean follow-up period of 4.5 years . Patients experiencing cardiovascular events ( n=91 ) had lower vasodilator responses to acetylcholine ( P < 0.001 ) and sodium nitroprusside ( P < 0.05 ) , but greater benefit from vitamin C ( P < 0.01 ) . The Cox proportional regression analysis for conventional risk factors demonstrated that blunted acetylcholine-induced vasodilation ( P = 0.001 ) , the effect of vitamin C ( P = 0.001 ) , and age ( P = 0.016 ) remained independent predictors of cardiovascular events . Conclusions —Endothelial dysfunction and increased vascular oxidative stress predict the risk of cardiovascular events in patients with coronary artery disease . These data support the concept that oxidative stress may contribute not only to endothelial dysfunction but also to coronary artery disease activity Background —Dilated cardiomyopathy is characterized by an imbalance between left ventricular performance and myocardial energy consumption . Experimental models suggest that oxidative stress result ing from increased xanthine oxidase ( XO ) activity contributes to this imbalance . Accordingly , we hypothesized that XO inhibition with intracoronary allopurinol improves left ventricular efficiency in patients with idiopathic dilated cardiomyopathy . Methods and Results — Patients ( n=9 ; ejection fraction , 29±3 % ) were instrumented to assess myocardial oxygen consumption ( M&OV0312;o2 ) , peak rate of rise of left ventricular pressure ( dP/dtmax ) , stroke work ( SW ) , and efficiency ( dP/dtmax/M&OV0312 ; o2 and SW/M&OV0312;o2 ) at baseline and after sequential infusions of intracoronary allopurinol ( 0.5 , 1.0 , and 1.5 mg/min , each for 15 minutes ) . Allopurinol caused a significant decrease in M&OV0312;o2 ( peak effect , −16±5%;P < 0.01 ; n=9 ) with no parallel decrease in dP/dtmax or SW and no change in ventricular load . The net result was a substantial improvement in myocardial efficiency ( peak effects : dP/dtmax/M&OV0312 ; o2 , 22±9 % , n=9 ; SW/M&OV0312 ; o2 , 40±17 % , n=6 ; both P < 0.05 ) . These effects were apparent despite concomitant treatment with st and ard heart failure therapy , including ACE inhibitors and & bgr;-blockers . XO and its parent enzyme xanthine dehydrogenase were more abundant in failing explanted human myocardium on immunoblot . Conclusions —These findings indicate that XO activity may contribute to abnormal energy metabolism in human cardiomyopathy . By reversing the energetic inefficiency of the failing heart , pharmacological XO inhibition represents a potential novel therapeutic strategy for the treatment of human heart failure Background and Purpose — Elevated serum uric acid level is associated with poor outcome and increased risk of recurrent events after stroke . The xanthine oxidase inhibitor allopurinol lowers uric acid but also attenuates expression of inflammatory adhesion molecules in murine models , reduces oxidative stress in the vasculature , and improves endothelial function . We sought to investigate whether allopurinol alters expression of inflammatory markers after acute ischemic stroke . Methods — We performed a r and omized , double-blind , placebo-controlled trial to investigate the safety , tolerability , and effect of 6 weeks ' treatment with high- ( 300 mg once a day ) or low- ( 100 mg once a day ) dose allopurinol on levels of uric acid and circulating inflammatory markers after ischemic stroke . Results — We enrolled 50 patients with acute ischemic stroke ( 17 , 17 , and 16 in the high , low , and placebo groups , respectively ) . Mean ( ±SD ) age was 70 ( ±13 ) years . Groups had similar characteristics at baseline . There were no serious adverse events . Uric acid levels were significantly reduced at both 7 days and 6 weeks in the high-dose group ( by 0.14 mmol/L at 6 weeks , P=0.002 ) . Intercellular adhesion molecule-1 concentration ( ng/mL ) rose by 51.2 in the placebo group , rose slightly ( by 10.6 ) in the low-dose allopurinol group , but fell in the high-dose group ( by 2.6 ; difference between groups P=0.012 , Kruskal-Wallis test ) . Conclusion — Allopurinol treatment is well tolerated and attenuates the rise in intercellular adhesion molecule-1 levels seen after stroke . Uric acid levels were lowered with high doses . These findings support further evaluation of allopurinol as a preventive measure after stroke Increased oxidative stress in obstructive sleep apnoea is thought to contribute to endothelial dysfunction . The objective of this study was to test the hypothesis that inhibition of xanthine oxidase by allopurinol can improve endothelial function in patients with obstructive sleep apnoea . A r and omised double-blind placebo-controlled crossover study was performed on 12 patients with moderate-to-severe obstructive sleep apnoea , comparing 300 mg allopurinol daily for 2 weeks with placebo . Endothelial function was assessed using hyperaemia-induced flow-mediated vasodilation ( FMD ) at baseline and following treatment . Plasma malondialdehyde levels were compared in order to assess significant changes in oxidative stress . Baseline FMD correlated significantly with the severity of sleep apnoea and the time spent with an arterial oxygen saturation of < 90 % . Allopurinol caused a significant increase in FMD compared to placebo ( 10.4±3.2 versus 7.4±2.8 % , respectively ) . Plasma malondialdehyde levels were significantly reduced with allopurinol treatment ( 1.5±0.3 versus 1.2±0.3 μmol·L−1 ) , consistent with reduced oxidative stress . Allopurinol improves endothelial dysfunction in patients with moderate-to-severe obstructive sleep apnoea . These observations suggest that xanthine oxidase contributes significantly to vasodilatory impairment AIMS Allopurinol improves endothelial function in chronic heart failure by reducing oxidative stress . We wished to explore if such an effect would attenuate autonomic dysfunction in CHF in line with many other effective therapies in CHF . METHODS We performed a prospect i ve , r and omized , double-blind cross-over study in 16 patients with NYHA Class II-IV chronic heart failure ( mean age 67 + /- 10 years , 13 male , comparing allopurinol ( 2 months ) at a daily dose of 300 mg ( if creatinine < 150 micromol l-1 ) or 100 mg ( if creatinine > 150 micromol l-1 ) with matched placebo . Mean heart rate and dysrhythmia counts were recorded from 24 h Holter tapes at monthly intervals for 6 months . We assessed autonomic function using st and ard time domain heart rate variability parameters ( HRV ) : SDNN , SDANN , SDNN index , rMSSD and TI . RESULTS Allopurinol had no significant effect on heart rate variability compared with placebo ; the results are expressed as a difference in means + /- s.d . with 95 % confidence interval ( CI ) between allopurinol and placebo : SDNN mean = 6.5 + /- 4.8 ms , P = 0.18 and 95 % CI ( -3.7 , 17 ) ; TI mean = -2.1 + /- 1.4 , P = 0.16 and 95 % CI ( -5.2 , 0.8 ) ; SDANN mean = -2.8 + /- 7 ms , P = 0.68 and 95 % CI ( -18 , 12 ) ; SDNNi mean = 2 + /- 6.6 , P = 0.7 and 95 % CI ( -12 , 16 ) ; RMSSD mean = -0.9 + /- 2 , P = 0.68 and 95 % CI ( -5.6 , 3.7 ) . For mean heart rate the corresponding results were 0.9 + /- 1.4 , P = 0.5 and 95 % CI ( -2 , 3.8 ) . Log 24 h ventricular ectopic counts ( VEC ) were 0.032 + /- 0.37 , P = 0.7 and 95 % CI ( -0.1 , 0.2 ) . Patient compliance with study medication was good since allopurinol showed its expected effect of reducing plasma uric acid ( P < 0.001 ) . CONCLUSIONS Allopurinol at doses , which are known to reduce oxidative stress appear to have no significant effect on resting autonomic tone , as indicated by time domain heart rate variability or on dysrhythmia count in stable heart failure patients Background —In patients with chronic heart failure ( CHF ) , hyperuricemia is a common finding and is associated with reduced vasodilator capacity and impaired peripheral blood flow . It has been suggested that the causal link of this association is increased xanthine oxidase (XO)–derived oxygen free radical production and endothelial dysfunction . We therefore studied the effects of XO inhibition with allopurinol on endothelial function and peripheral blood flow in CHF patients after intra-arterial infusion and after oral administration in 2 independent placebo-controlled studies . Methods and Results —In 10 CHF patients with normal serum uric acid ( UA ) levels ( 315±42 & mgr;mol/L ) and 9 patients with elevated UA ( 535±54 & mgr;mol/L ) , endothelium-dependent ( acetylcholine infusion ) and endothelium-independent ( nitroglycerin infusion ) vasodilation of the radial artery was determined . Coinfusion of allopurinol ( 600 & mgr;g/min ) \n Output:\n " }, { "from": "agent", "value": "XOI improves endothelial function and circulating markers of oxidative stress in patients with , or at risk of , cardiovascular disease ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The possible role of cows milk intolerance in the aetiology of infant colic was evaluated in 19 babies presenting to their health visitor or general practitioner in one town . Over a three week period a st and ard modified cows milk formula was compared with a soya milk formula on a double blind basis . The duration of colic symptoms was significantly reduced during the week on soya milk ( P less than 0.01 ) , with 11 out of 19 babies fulfilling the diagnostic criteria for cows milk intolerance . Four babies whose symptoms failed to improve either spontaneously or with soya milk were given a hydrolysed protein milk with a positive response in two , confirmed by challenge testing . Thus in 13 out of 19 babies ( 68 % ) the symptoms of infant colic resolved almost completely with dietary change Transient lactose intolerance has been identified as a possible causative factor in infant colic . A double-blind r and omised placebo-controlled crossover study to investigate this has been undertaken in 53 babies with symptoms of colic . Pre-incubation of the feed with lactase result ed in breath hydrogen levels and total crying time which were both at least 45 % lower than figures with placebo treatment , in 26 % of the full trial group ( 95 % confidence interval 12.9 % to 44.4 % ) , and in 38 % of compliers ( 95 % confidence interval 18.8 % to 59.4 % ) . The remainder did not respond to the same extent . These findings suggest that infant colic may have a multiple aetiology , and that in a significant number of cases the immediate cause is transient lactose intolerance , in which cases pretreatment of feeds with lactase can result in considerable symptomatic benefits OBJECTIVE To determine the effectiveness of whey hydrolysate formula in the treatment of infantile colic in a primary care setting in the Netherl and s. STUDY DESIGN R and omized , double-blind , parallel trial with a 1-week qualification period and a 1-week intervention period . Participants . Forty-three healthy , thriving , formula-fed infants , < 6 months old , crying > 3 hours per day on at least 3 days per week . Infants were r and omized to whey hydrolysate formula ( n = 23 ) or st and ard formula ( n = 20 ) . MAIN OUTCOME MEASURE Difference in duration of crying ( minutes per day ) between qualification week and intervention week . RESULTS Analysis according to the intention to treat principle showed a difference in the decrease of crying duration of 63 minutes per day [ 95 % confidence interval : 1 - 127 minutes per day ] in favor of the whey hydrolysate formula . Five infants did not complete the trial . The scope of the study was not sufficient to expect significant differences in the subgroup analyses . CONCLUSIONS An extensively hydrolyzed whey formula is effective in reducing the duration of crying in a primary care setting BACKGROUND The effect of diet change in 38 bottle-fed and 77 breast-fed \" colicky \" infants , referred from community-based pediatric facilities was studied over a 1-week period in a double-blind ( within each feeding mode ) , r and omized , placebo-controlled trial . METHODS Bottle-fed infants were assigned to either casein hydrolysate or cow 's milk formula . All mothers of breast-fed infants were started on an artificial color-free , preservative-free , additive-free diet and also r and omized to an active low allergen diet ( milk- , egg- , wheat- , nut-free ) or a control diet . RESULTS The response to diet was assessed on day 1 and day 8 with the use of a previously vali date d infant distress chart on which parents recorded distress levels . If successful outcome was defined as a reduction in distress of 25 % or more , after adjusting for age and feeding mode , infants on active diet had a significantly higher rate of improvement than those on the control diet ( odds ratio , 2.32 ; 95 % confidence interval , 1.07 - 5.0 ; p = 0.03 ) . Analysis of the day 8 to day 1 distress ratio , again adjusted for age and feeding mode , showed that infants on the active diet had distress reduced by 39 % ( 95 % confidence interval , 26 - 50 ) compared with 16 % ( 95 % confidence interval , 0 - 30 ) for those on the control diet ( p = 0.012 ) . CONCLUSION The results suggest a period of dietary modification with a low allergen diet and appropriate nutritional support should be considered in healthy infants with colic The role of cow 's milk in infantile colic in formula-fed infants was estimated in a double-blind study . Sixty colicky infants were given a cow 's milk-containing formula ( Enfamil ) and a cow 's milk-free formula based on soy ( ProSobee ) . Eleven infants ( 18 % ) were free of symptoms while receiving soy formula . Symptoms of 32 infants ( 53 % ) were unchanged or worse when they were fed cow 's milk formula and soy formula , but symptoms disappeared when they were fed a formula containing hydrolyzed casein ( Nutramigen ) . Symptoms of 17 infants ( 29 % ) could not be related to the diet ; these infants were permitted to continue on a cow 's milk-based formula . A challenge with cow 's milk-based formula after one month ( at approximately age 3 months ) produced symptoms of infantile colic in 22 infants ( 36 % ) . At age 6 months , a challenge with cow 's milk was positive in 11 infants ( 18 % ) with epidermal and gastrointestinal symptoms . Eight infants ( 13 % ) at 12 months of age and five infants ( 8 % ) at 16 months of age were still intolerant to cow 's milk . Cow 's milk seems to be a major cause of infantile colic in formula-fed infants . A dietary treatment is suggested for moderate or severe forms of the colic . Cow 's milk protein intolerance is common later in infancy in these infants \n Output:\n " }, { "from": "agent", "value": "There is insufficient evidence to support the cl aims that removing or reducing lactose , using hydrolyzed or soy protein or adding pre-/probiotics to formula benefits infants with fussiness , gas , or colic yet cl aims like “ soy for fussiness and gas ” encourage parents who perceive their infants to be fussy to purchase modified formula ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE To determine the effectiveness of community based occupational therapy on daily functioning of patients with dementia and the sense of competence of their care givers . DESIGN Single blind r and omised controlled trial . Assessors were blinded for treatment allocation . SETTING Memory clinic and day clinic of a geriatrics department and participants ' homes . PARTICIPANTS 135 patients aged > or = 65 with mild to moderate dementia living in the community and their primary care givers . INTERVENTIONS 10 sessions of occupational therapy over five weeks , including cognitive and behavioural interventions , to train patients in the use of aids to compensate for cognitive decline and care givers in coping behaviours and supervision . MAIN OUTCOME MEASURES Patients ' daily functioning assessed with the assessment of motor and process skills ( AMPS ) and the performance scale of the interview of deterioration in daily activities in dementia ( IDDD ) . Care giver burden assessed with the sense of competence question naire ( SCQ ) . Participants were evaluated at baseline , six weeks , and three months . RESULTS Scores improved significantly relative to baseline in patients and care givers in the intervention group compared with the controls ( differences were 1.5 ( 95 % confidence interval 1.3 to 1.7 ) for the process scale ; -11.7 ( -13.6 to -9.7 ) for the performance scale ; and ( 11.0 ; 9.2 to 12.8 ) for the competence scale ) . This improvement was still significant at three months . The number needed to treat to reach a clinical ly relevant improvement in motor and process skills score was 1.3 ( 1.2 to 1.4 ) at six weeks . Effect sizes were 2.5 , 2.3 , and 1.2 , respectively , at six weeks and 2.7 , 2.4 , and 0.8 , respectively , at 12 weeks . CONCLUSIONS Occupational therapy improved patients ' daily functioning and reduced the burden on the care giver , despite the patients ' limited learning ability . Effects were still present at 12 weeks , which justifies implementation of this intervention . TRIAL REGISTRATION Clinical Trials NCT00295152 [ Clinical Trials.gov ] Spouse-caregivers of Alzheimer 's disease patients were r and omly assigned to either a treatment group ( individual and family counseling , support group participation , and ad hoc consultation ) or a control group ( only routine support ) . In the first year after intake , the treatment group had less than half as many nursing home placements as the control group . This suggests that a comprehensive counseling program can reduce the socioeconomic impact of Alzheimer 's disease . Nursing home placement also was affected by the patient 's need for assistance with activities of daily living , patient income , and the age of the patients and caregivers CONTEXT Optimal treatment to postpone functional decline in patients with dementia is not established . OBJECTIVE To test a nonpharmacologic intervention realigning environmental dem and s with patient capabilities . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve 2-group r and omized trial ( Care of Persons with Dementia in their Environments [ COPE ] ) involving patients with dementia and family caregivers ( community-living dyads ) recruited from March 2006 through June 2008 in Pennsylvania . INTERVENTIONS Up to 12 home or telephone contacts over 4 months by health professionals who assessed patient capabilities and deficits ; obtained blood and urine sample s ; and trained families in home safety , simplifying tasks , and stress reduction . Control group caregivers received 3 telephone calls and educational material s. MAIN OUTCOME MEASURES Functional dependence , quality of life , frequency of agitated behaviors , and engagement for patients and well-being , confidence using activities , and perceived benefits for caregivers at 4 months . RESULTS Of 284 dyads screened , 270 ( 95 % ) were eligible and 237 ( 88 % ) r and omized . Data were collected from 209 dyads ( 88 % ) at 4 months and 173 ( 73 % ) at 9 months . At 4 months , compared with controls , COPE patients had less functional dependence ( adjusted mean difference , 0.24 ; 95 % CI , 0.03 - 0.44 ; P = .02 ; Cohen d = 0.21 ) and less dependence in instrumental activities of daily living ( adjusted mean difference , 0.32 ; 95 % CI , 0.09 - 0.55 ; P = .007 ; Cohen d = 0.43 ) , measured by a 15-item scale modeled after the Functional Independence Measure ; COPE patients also had improved engagement ( adjusted mean difference , 0.12 ; 95 % CI , 0.07 - 0.22 ; P = .03 ; Cohen d = 0.26 ) , measured by a 5-item scale . COPE caregivers improved in their well-being ( adjusted mean difference in Perceived Change Index , 0.22 ; 95 % CI , 0.08 - 0.36 ; P = .002 ; Cohen d = 0.30 ) and confidence using activities ( adjusted mean difference , 0.81 ; 95 % CI , 0.30 - 1.32 ; P = .002 ; Cohen d = 0.54 ) , measured by a 5-item scale . By 4 months , 64 COPE dyads ( 62.7 % ) vs 48 control group dyads ( 44.9 % ) eliminated 1 or more caregiver-identified problems ( chi(2/1 ) = 6.72 , P = . 01 ) . CONCLUSION Among community-living dyads , a nonpharmacologic biobehavioral environmental intervention compared with control result ed in better outcomes for COPE dyads at 4 months . Although no group differences were observed at 9 months for patients , COPE caregivers perceived greater benefits . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00259454 The goal of this study was to evaluate a community-based psychoeducational-nursing intervention design ed to teach home caregivers to manage behavioral problems of persons with Alzheimer 's disease and related dementias ( ADRD ) using the Progressively Lowered Stress Threshold ( PLST ) model , and to compare this intervention with routine information and referrals for case management , community-based services , and support groups . Previous caregiver studies have overwhelmingly pointed to the adverse effects of caregiving on the caregivers ' physical and mental health , and high prevalence rates of depression among caregivers of persons with ADRD have consistently been reported . Therefore , a primary aim was to evaluate the impact of the intervention on caregivers ' affective responses , especially depression . Data from both the Profile of Moods States and the Geriatric Depression Rating Scale support the effectiveness of this intervention in decreasing depression among caregivers who received the experimental training . Additional analysis of factors associated with caregiver depression are also reported . The pivotal role of psychiatric nurses in the assessment and treatment of depression among caregivers of persons with ADRD is discussed Seven caregivers of a home-dwelling spouse with Alzheimer 's disease were trained during 12 weekly home visits to implement behavior management programs including written cuing procedures in response to repetitive verbalizations . Data from 7 trained caregivers and 7 matched control caregivers who only tracked repetitive behavior were compared . Results revealed that trained caregivers were successful at decreasing patient repetitions using written cues . Patients of control subjects showed no systematic changes in behavioral disturbances due to behavior tracking . In addition , intervention effects lasted for 16 weeks or longer and several caregivers reported applying the cuing intervention to other , nontargeted behaviors . Trained caregivers ' perceptions of their efficacy in managing difficult patient behavior improved significantly at the 3-month follow-up assessment when program staff were no longer visiting them weekly Although the literature is replete with studies examining the psychological concomitants and interventions for Alzheimer 's disease ( AD ) family caregivers , a surprisingly small amount of research exists on anxiety . Given prevalence rates suggesting that anxiety significantly impacts one in three family caregivers , brief group cognitive-behavioral therapy ( CBT ) interventions may offer assistance . To assess CBT 's effectiveness , 38 anxious AD family caregivers were recruited and r and omly assigned to a nine-week group CBT intervention or to a waitlist control . Caregivers r and omized to CBT demonstrated less anxiety on self-report and clinician-administered question naires than waitlist group participants at posttreatment and six-week follow-up assessment s. A sub sample of caregivers also demonstrated improved sleep , as assessed through actigraph measurements . Additional study is recommended with diverse anxious family caregiving groups to further investigate the effectiveness of brief CBT group interventions PURPOSE This study examines the short-term impact of two theoretically based psychoeducational small group interventions with distressed caregivers , and it also examines the role of specific moderator and mediator variables on caregiver outcomes . DESIGN AND METHODS Female participants ( N = 169 ) aged 50 and older who were caring for a community-dwelling relative with a dementing illness were r and omly assigned to one of three treatment interventions : anger management , depression management , or a wait-list control group . These interventions took place over a 3- to 4-month period . The primary outcomes examined were anger or hostile mood , depressed mood , frequency of use of positive and negative coping strategies , and perceived caregiving self-efficacy . RESULTS Significant main effects in the expected direction were found for changes in most of these measures . Participants in both anger management and depression management groups had significant reductions in their levels of anger or hostility and depression from Time 1 to Time 2 in comparison to participants in the wait-list control group . Use of positive cognitive coping strategies increased in the anger management group only . Self-efficacy significantly increased for participants in both intervention groups , and it was also demonstrated to function as a mediator of intervention effects . Pretreatment levels of depressive symptoms and anger expression style ( Anger Expression-Out ) moderated the relative effects of the two interventions on mood and coping . IMPLICATION S These data are consistent with a growing body of evidence supporting the effectiveness of skills training , in small groups , to improve both the affective states and the type of coping strategies used by caregivers . In addition , this study underscores the need to evaluate key pretreatment variables in order to determine which form of treatment may be more compatible with caregiver characteristics and thus more likely to be beneficial to individuals The current study is a controlled clinical investigation of two nonpharmacological treatments of depression in patients with Alzheimer 's disease . Two active behavioral treatments , one emphasizing patient pleasant events and one emphasizing caregiver problem solving , were compared to an equal- duration typical care condition and a wait list control . Seventy-two patient-caregiver dyads were r and omly assigned to one of four conditions and assessed pre- , post- , and at 6-months follow-up . Patients in both behavioral treatment conditions showed significant improvement in depression symptoms and diagnosis as compared with the two other conditions . These gains were maintained at 6-month follow-up . Caregivers in each behavioral condition also showed significant improvement in their own depressive symptoms , while caregivers in the two other conditions did not . Results indicate that behavioral interventions for depression are important and effective strategies for treating demented patients and their caregivers PURPOSE We determine the main outcome effects of a 12-month computer-mediated automated interactive voice response ( IVR ) intervention design ed to assist family caregivers managing persons with disruptive behaviors related to Alzheimer 's disease ( AD ) . DESIGN AND METHODS We conducted a r and omized controlled study of 100 caregivers , 51 in the usual care control group and 49 in the technology intervention group , who received yearlong access to an IVR-mediated system . The system provided caregiver stress monitoring and counseling information , personal voice-mail linkage to AD experts , a voice-mail telephone support group , and a distraction call for care recipients . We conducted analyses by using a repeated measures approach for longitudinal data and an intention-to-treat analytic approach . Outcomes included the caregiver 's appraisal of the bothersome nature of caregiving , anxiety , depression , and mastery at baseline , 6 , 12 , and 18 months . RESULTS There was a significant intervention effect as hypothesized for participants with lower mastery at baseline on all three outcomes : bother ( p = .04 ) , anxiety ( p = .01 ) , and depression ( p = .007 ) . Additionally , wives exhibited a significant intervention effect in the reduction of the bothersome nature of caregiving ( p = .02 ) . IMPLICATION S Wives who exhibited low mastery and high anxiety benefited the most from the automated telecare intervention . Findings suggest that , to optimize outcome effects , similar interventions should be tailored to match the users ' characteristics and preferences BACKGROUND The study objective was to determine the health and quality -of-life effects of moderate-intensity exercise among older women family caregivers . METHODS This 12-month r and omized controlled trial involved a volunteer sample of 100 women aged 49 to 82 years who were sedentary , free of cardiovascular disease , and caring for a relative with dementia . Participants were r and omized to 12 months of home-based , telephone-supervised , moderate-intensity exercise training or to an attention-control ( nutrition education ) program . Exercise consisted of four 30- to 40-minute endurance exercise sessions ( brisk walking ) prescribed per week at 60 % to 75 % of heart rate reserve based on peak treadmill exercise heart rate . Main out \n Output:\n " }, { "from": "agent", "value": "Most positive effects were found in caregivers of people with a diagnosis of ' dementia not otherwise specified ' and in the subgroup of female caregivers .\nExamples of outcomes were decreased depression and improved self-efficacy .\nCONCLUSIONS This study gives a first overview of successful psychosocial interventions in subgroups of caregivers of people with dementia ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Sentinel lymph node biopsy ( SLNB ) is the st and ard surgical procedure for the axilla in early node-negative breast cancer . To date , the \" gold st and ard \" to localize the sentinel lymph node ( SLN ) is the radiotracer (99m)Tc with or without blue dye . The aim of this study was to evaluate potential equivalency of the new SentiMag ( ® ) technique in comparison to the \" gold st and ard \" . Within this prospect i ve , multicentric and multinational non-inferiority study including 150 patients (99m)Tc was compared with the magnetic technique , using superparamagnetic iron oxide particles ( SPIOs , Sienna+ ( ® ) ) for localization of SLNs . The results showed a detection rate per patient of 97.3 % ( 146/150 ) for (99m)Tc vs. 98.0 % ( 147/150 ) for Sienna+ ( ® ) with a similar average number of removed SLNs per patient and a higher per patient malignancy detection rate for the SPIO tracer . We obtained convincing results that magnetic SLNB can be performed easily , safely and equivalently well in comparison to the radiotracer method Background Sentinel lymph node biopsy ( SLNB ) in melanoma is currently performed using the st and ard dual technique ( radioisotope and blue dye ) . The magnetic technique is non-radioactive and provides a brown color change in the sentinel lymph node ( SLN ) through an intradermal injection of a magnetic tracer , and utilizes a h and held magnetometer . The MELAMAG Trial compared the magnetic technique with the st and ard technique for SLNB in melanoma . Methods Clinical ly node-negative patients with primary cutaneous melanoma were recruited from four centers . SLNB was undertaken after intradermal administration of both the st and ard ( blue dye and radioisotope ) and magnetic tracers . The SLN identification rate per patient , with the two techniques , was compared . Results A total of 133 patients were recruited , 129 of which were available for final analysis . The sentinel node identification rate was 97.7 % ( 126/129 ) with the st and ard technique and 95.3 % ( 123/129 ) with the magnetic technique [ 2.3 % difference ; 95 % upper confidence limit ( CL ) 6.4 ; 5.4 % discordance ] . With radioisotope alone , the SLN identification rate was 95.3 % ( 123/129 ) , as with the magnetic technique ( 0 % difference ; 95 % upper CL 4.5 ; 7.8 % discordance ) . The lymph node retrieval rate was 1.99 nodes per patient overall , 1.78 with the st and ard technique and 1.87 with the magnetic technique . Conclusions The magnetic technique is feasible for SLNB in melanoma with a high SLN identification rate , but is associated with skin staining . When compared with the st and ard dual technique , it did not reach our predefined non-inferiority margin BACKGROUND AND OBJECTIVES The French Sentimag feasibility trial evaluated a new method for the localization of breast cancer sentinel lymph node ( SLN ) using Sienna+ ® , superparamagnetic iron oxide particles , and Sentimag ® detection in comparison to the st and ard technique ( isotopes ± blue dye ) . METHODS We conducted a prospect i ve multicentric paired comparison trial on 115 patients . SLN localization was performed using both the magnetic technique and the st and ard method . Detection rate and concordance between magnetic and st and ard tracers were calculated . Post-operative complications were assessed after 30 days . RESULTS Results are based on 108 patients . SLN identification rate was 98.1 % [ 93.5 - 99.8 ] for both methods , 97.2 % [ 92.1 - 99.4 ] for Sienna+ ® and 95.4 % [ 89.5 - 98.5 ] for st and ard technique . A mean of 2.1 SLNs per patient was removed . The concordance rate was 99.0 % [ 94.7 - 100.0 % ] per patient and 97.4 % [ 94.1 - 99.2 ] per node . Forty-six patients ( 43.4 % ) had nodal involvement . Among involved SLNs , concordance rate was 97.7 % [ 88.0 - 99.9 ] per patient and 98.1 % [ 90.1 - 100.0 ] per node . CONCLUSIONS This new magnetic tracer is a feasible method and a promising alternative to the isotope . It could offer benefits for ambulatory surgery or sites without nuclear medicine departments . J. Surg . Oncol . 2016;113:501 - 507 . © 2016 Wiley Periodicals , Background The r and omized EORTC 10981 - 22023 AMAROS trial investigates whether breast cancer patients with a tumor-positive sentinel node biopsy ( SNB ) are best treated with an axillary lymph node dissection ( ALND ) or axillary radiotherapy ( ART ) . The aim of the current sub study was to evaluate the identification rate and the nodal involvement . Methods The first 2,000 patients participating in the AMAROS trial were evaluated . Associations between the identification rate and technical , patient- , and tumor-related factors were evaluated . The outcome of the SNB procedure and potential further nodal involvement was assessed . Results In 65 patients , the sentinel node could not be identified . As a result , the sentinel node identification rate was 97 % ( 1,888 of 1,953 ) . Variables affecting the success rate were age , pathological tumor size , histology , year of accrual , and method of detection . The SNB results of 65 % of the patients ( n = 1,220 ) were negative and the patients underwent no further axillary treatment . The SNB results were positive in 34 % of the patients ( n = 647 ) , including macrometastases ( n = 409 , 63 % ) , micrometastases ( n = 161 , 25 % ) , and isolated tumor cells ( n = 77 , 12 % ) . Further nodal involvement in patients with macrometastases , micrometastases , and isolated tumor cells undergoing an ALND was 41 , 18 , and 18 % , respectively . Conclusions With a 97 % detection rate in this prospect i ve international multicenter study , the SNB procedure is highly effective , especially when the combined method is used . Further nodal involvement in patients with micrometastases and isolated tumor cells in the sentinel node was similar — both were 18 % BACKGROUND Sentinel lymph node biopsy in women with operable breast cancer is routinely used in some countries for staging the axilla despite limited data from r and omized trials on morbidity and mortality outcomes . We conducted a multicenter r and omized trial to compare quality -of-life outcomes between patients with clinical ly node-negative invasive breast cancer who received sentinel lymph node biopsy and patients who received st and ard axillary treatment . METHODS The primary outcome measures were arm and shoulder morbidity and quality of life . From November 1999 to October 2003 , 1031 patients were r and omly assigned to undergo sentinel lymph node biopsy ( n = 515 ) or st and ard axillary surgery ( n = 516 ) . Patients with sentinel lymph node metastases proceeded to delayed axillary clearance or received axillary radiotherapy ( depending on the protocol at the treating institution ) . Intention-to-treat analyses of data at 1 , 3 , 6 , and 12 months after surgery are presented . All statistical tests were two-sided . RESULTS The relative risks of any lymphedema and sensory loss for the sentinel lymph node biopsy group compared with the st and ard axillary treatment group at 12 months were 0.37 ( 95 % confidence interval [ CI ] = 0.23 to 0.60 ; absolute rates : 5 % versus 13 % ) and 0.37 ( 95 % CI = 0.27 to 0.50 ; absolute rates : 11 % versus 31 % ) , respectively . Drain usage , length of hospital stay , and time to resumption of normal day-to-day activities after surgery were statistically significantly lower in the sentinel lymph node biopsy group ( all P < .001 ) , and axillary operative time was reduced ( P = .055 ) . Overall patient-recorded quality of life and arm functioning scores were statistically significantly better in the sentinel lymph node biopsy group throughout ( all P < or = .003 ) . These benefits were seen with no increase in anxiety levels in the sentinel lymph node biopsy group ( P > .05 ) . CONCLUSION Sentinel lymph node biopsy is associated with reduced arm morbidity and better quality of life than st and ard axillary treatment and should be the treatment of choice for patients who have early-stage breast cancer with clinical ly negative nodes A mini-symposium was held in Montreal , Canada , at the International Surgical Week for the Breast Surgical International in 2007 addressing the question whether breast cancer is the same disease in Asian and Western countries . Numerous investigators from Asian and Western countries presented the epidemiologic and clinical outcome data of women with breast cancer . Although there are significant similarities , the striking difference is that the peak age for breast cancer is between 40 and 50 years in the Asian countries , whereas the peak age in the Western countries is between 60 and 70 years . Also , the incidence of breast cancer in Asia is rising and is associated with increased mortality . In the West , although the incidence is increasing , the mortality rate is definitely decreasing . Future prospect i ve data collection from Asian and Western countries may provide further interesting epidemiologic and outcome data regarding the outcome of women with breast cancer from Asian and Western countries . Background Whether breast cancer is the same disease in Asian and Western countries was the topic of a 2007 Breast Surgery International symposium at International Surgical Week . Methods Participating investigators from China , Taiwan , India , Japan , South Korea , Sweden , Canada , and the United States were asked beforeh and to provide data on the epidemiology and treatment outcome of women in their countries . Results Comparisons of the epidemiologic and clinical outcome data of women with breast cancer showed significant similarities , but the striking difference is that the peak age is between 40 and 50 years in Asian countries , but is between 60 and 70 years in Western countries . The incidence of breast cancer in Asia is rising and is associated with increased mortality . In the West , although the incidence is also increasing , the mortality rate is definitely decreasing . Discussion Future prospect i ve data collection from Asian and Western countries may provide further interesting epidemiologic and outcome data regarding the outcome of women with breast cancer from Asian and Western countries Background [99mTc]Tilmanocept is a CD206 receptor-targeted radiopharmaceutical design ed for sentinel lymph node ( SLN ) identification . Two nearly identical nonr and omized phase III trials compared [99mTc]tilmanocept to vital blue dye . Methods Patients received [99mTc]tilmanocept and blue dye . SLNs identified intraoperatively as radioactive and /or blue were excised and histologically examined . The primary end point , concordance , was the proportion of blue nodes detected by [99mTc]tilmanocept ; 90 % concordance was the prespecified minimum concordance level . Reverse concordance , the proportion of radioactive nodes detected by blue dye , was also calculated . The prospect i ve statistical plan combined the data from both trials . Results Fifteen centers contributed 154 melanoma patients who were injected with both agents and were intraoperatively evaluated . Intraoperatively , 232 of 235 blue nodes were detected by [99mTc]tilmanocept , for 98.7 % concordance ( p < 0.001 ) . [99mTc]Tilmanocept detected 364 nodes , for 63.7 % reverse concordance ( 232 of 364 nodes ) . [99mTc]Tilmanocept detected at least one node in more patients ( n = 150 ) than blue dye ( n = 138 , p = 0.002 ) . In 135 of 138 patients with at least one blue node , all blue nodes were radioactive . Melanoma was identified in the SLNs of 22.1 % of patients ; all 45 melanoma-positive SLNs were detected by [99mTc]tilmanocept , whereas blue dye detected only 36 ( 80 % ) of 45 ( p = 0.004 ) . No positive SLNs were detected exclusively by blue dye . Four of 34 node-positive patients were identified only by [99mTc]tilmanocept , so 4 ( 2.6 % ) of 154 patients were correctly staged only by [99mTc]tilmanocept . No serious adverse events were attributed to [99mTc]tilmanocept . Conclusions [99mTc]Tilmanocept met the prespecified concordance primary end point , identifying 98.7 % of blue nodes . It identified more SLNs in more patients , and identified more melanoma-containing nodes than blue dye Background The SentiMAG Multicentre Trial evaluated a new magnetic technique for sentinel lymph node biopsy ( SLNB ) against the st and ard ( radioisotope and blue dye or radioisotope alone ) . The magnetic technique does not use radiation \n Output:\n " }, { "from": "agent", "value": "The magnetic technique for SLNB is non-inferior to the st and ard technique , with a high identification rate but with a significantly higher lymph node retrieval rate" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results BACKGROUND Greater thoracic kyphosis is associated with increased biomechanical loading of the spine which is potentially problematic in individuals with osteoporotic vertebral fractures . Conservative interventions that reduce thoracic kyphosis warrant further investigation . This study aim ed to investigate the effects of therapeutic postural taping on thoracic posture . Secondary aims explored the effects of taping on trunk muscle activity and balance . METHODS Fifteen women with osteoporotic vertebral fractures participated in this within-participant design study . Three taping conditions were r and omly applied : therapeutic taping , control taping and no taping . Angle of thoracic kyphosis was measured after each condition . Force plate-derived balance parameters and trunk muscle electromyographic activity ( EMG ) were recorded during three static st and ing tasks of 40s duration . RESULTS There was a significant main effect of postural taping on thoracic kyphosis ( p=0.026 ) , with a greater reduction in thoracic kyphosis after taping compared with both control tape and no tape . There were no effects of taping on EMG or balance parameters . CONCLUSIONS The results of this study demonstrate that the application of postural therapeutic tape in a population with osteoporotic vertebral fractures induced an immediate reduction in thoracic kyphosis . Further research is needed to investigate the underlying mechanisms associated with this decrease in kyphosis Background It is possible that cross-over studies included in current systematic review s are being inadequately assessed , because the current risk of bias tools do not consider possible biases specific to cross-over design . We performed this study to evaluate whether this was being done in cross-over studies included in Cochrane Systematic Review s ( CSRs ) . Methods We search ed the Cochrane Library ( up to 2013 issue 5 ) for CSRs that included at least one cross-over trial . Two authors independently undertook the study selection and data extraction . A r and om sample of the CSRs was selected and we evaluated whether the cross-over trials in these CSRs were assessed according to criteria suggested by the Cochrane h and book . In addition we reassessed the risk of bias of these cross-over trials by a checklist developed form the Cochrane h and book . Results We identified 688 CSRs that included one or more cross-over studies . We chose a r and om sample of 60 CSRs and these included 139 cross-over studies . None of these CSRs undertook a risk of bias assessment specific for cross-over studies . In fact items specific for cross-over studies were seldom considered anywhere in quality assessment of these CSRs . When we reassessed the risk of bias , including the 3 items specific to cross-over trials , of these 139 studies , a low risk of bias was judged for appropriate cross-over design in 110(79 % ) , carry-over effects in 48(34 % ) and for reporting data in all stages of the trial in 114(82 % ) . Assessment of biases in cross-over trials could affect the GRADE assessment of a review ’s findings . Conclusion The current Cochrane risk of bias tool is not adequate to assess cross-over studies . Items specific to cross-over trials leading to potential risk of bias are generally neglected in CSRs . A proposed check list for the evaluation of cross-over trials is provided OBJECT External supports serve as a traditional treatment option for osteoporotic vertebral fractures ( OVFs ) . However , the role of external supports in the treatment of OVF remains inconclusive . The purpose of this study was to determine the role of a rigid external support in the healing of OVFs by prospect ively evaluating union ( fracture settling ) rates and prognostic variables for patients suffering from an incident OVF . METHODS Fifty-five patients with acute back pain were enrolled in this study after being diagnosed with an OVF based on MRI findings . Patients were treated using a plastic thoracolumbosacral orthosis ( TLSO ) and underwent follow-up at 2 , 3 , and 6 months . Vertebrae were referred to as \" settled \" when there was no dynamic mobility on sitting lateral and supine lateral radiographs . At the time of the 3- and 6-month follow-up visits , the patients were divided into 2 groups , the \" settled group \" and the \" unsettled group . \" Patients in these groups were compared with regard to clinical and radiographic features . RESULTS Of the 55 patients enrolled , 53 patients were followed up for 6 months . There were 14 men and 39 women with an average age of 75.3 years . Fracture settling of the affected vertebra was defined in 54.7 % of the patients at 2 months , in 79.2 % at 3 months , and in 88.7 % at 6 months . All 5 components of the Japanese Orthopaedic Association Back Pain Evaluation Question naire improved significantly both at 3 months and 6 months . Patients in the unsettled group exhibited a statistically greater likelihood of having fractures at the thoracolumbar junction , Type A3 fractures , and fractures with a diffuse low-intensity area on T2-weighted MRI studies at 3 months . In contrast , at 6 months , the only statistically significant difference between the groups was patient age . CONCLUSIONS The biomechanical disadvantages of OVFs ( location , type , and size ) adversely influencing the fracture healing were overcome by the treatment using a TLSO within 6 months . The authors ' findings show that a TLSO plays a biomechanical role in the healing of OVFs OBJECTIVE To assess the changes in static and dynamic balance and movement strategies in patients with severe osteoporotic vertebral compression fracture while wearing and not wearing the Knight-Taylor ( K-T ) spinal brace . SUBJECTS 47 patients with severe osteoporotic vertebral compression fracture , which was confirmed on radiographs and with bone density measurements obtained by dual energy X-ray absorption . INTERVENTION Patients were r and omly subjected to computerized dynamic posturography , which contained sensory organization tests , motor control balance test at 75 % limit of stability ( LOS ) in 8 movement directions , and left/right rhythmic weight shift test ( L/R RWS ) , while wearing and not wearing the K-T spinal brace , respectively . RESULTS Patients wearing the spinal brace had significantly increased average stability , significantly increased average maximal stability under the swayed vision with fixed support surface condition and under the eye open with swayed support surface condition , significantly increased ankle strategy and decreased average velocity of COG target sway under the eye open with swayed support surface condition , significantly reduced the frequency of falls under the eye closed with swayed support surface condition and swayed vision with swayed support surface condition , and significantly decreased in the percentage of directional control with no difference of reaction time in the LOS test , and an increase in the on-axis velocity in the L/R RWS test . CONCLUSIONS The K-T spinal brace efficiently enables the subjects to maintain static and dynamic motor balance . Its use decreases the fall frequency but limits the directional control in severe osteoporotic patients with vertebral compression fracture Summary In a prospect i ve cohort study of 395 geriatric out patients , mortality after 3 years was associated with prevalent vertebral fractures at baseline . The mortality risk was independently associated with the presence of three or more vertebral fractures at baseline . In the surviving patients , the risk of incident fractures was noteworthy , occurring in 26 % of these patients . Introduction The purpose of this study is to determine mortality rate and the incidence of vertebral fractures in a geriatric outpatient group , during a 3-year follow-up period , in a teaching hospital in Amsterdam , The Netherl and s. Methods This study includes a prospect i ve cohort study of 395 geriatric patients who had their baseline visit at a diagnostic day hospital in 2007 and 2008 . They were invited for follow-up 3 years later . Lateral X-rays of the lumbar spine and chest were performed at baseline and after 3 years ; vertebral fractures were scored in all patients according to the semi-quantitative method of Genant . Results After 3 years , mortality was 46 % and associated with prevalent vertebral fractures at baseline ( odds ratio ( OR ) , 1.83 ; 95 % CI , 1.23–2.74 ) . The presence of three or more vertebral fractures at baseline was an independent risk factor for mortality ( OR , 3.32 ; 95 % CI , 1.56–7.07 ) . Other independently associated risk factors were greater age , higher co-morbidity score , and having more prescriptions . Higher cognitive capacity protected against mortality after 3 years . In 72 patients , radiography was repeated . Nineteen patients ( 26 % ) had an incident radiographic vertebral fracture : 16 in those with a prevalent fracture , and 3 in those without a prevalent vertebral fracture at baseline . Conclusions In geriatric out patients , mortality after 3 years was associated with prevalent vertebral fractures at baseline , and the mortality risk was independently associated with 3 or more vertebral fractures at baseline . In survivors , the risk of incident fractures was noteworthy , since these occurred in 26 % of the patients , particularly in those with a prevalent vertebral fracture Objectives : We conducted a prospect i ve r and omized study to evaluate the efficacy of two newly developed spinal orthoses in patients with vertebral fractures . Design : We conducted a prospect i ve , r and omized , cross-over study to evaluate the efficacy of two newly developed spinal orthoses in patients with osteoporotic vertebral fractures . Measurements include trunk muscle strength , angle of kyphosis , body height , body sway , and parameters of quality -of-life such as pain , well-being , and limitations of daily living . Results : Wearing the orthosis Spinomed during a 6-mo period ( results of Spinomed active are given in parentheses ) was associated with a 72 % ( 64 % ) increase in back extensor strength ( P < 0.01 ) , a 44 % ( 56 % ) increase in abdominal flexor strength ( P < 0.01 ) , an 11 % ( 11 % ) decrease in the angle of kyphosis ( P < 0.01 ) , a 23 % ( 20 % ) decrease in body sway ( P = 0.03 and P = 0.02 ) , a 19 % ( 18 % ) increase in vital capacity ( P < 0.01 and P = 0.03 ) , a 41 % ( 47 % ) decrease in average pain ( P < 0.01 ) , an 18 % ( 18 % ) increase in well-being ( P < 0.01 ) , and a 49 % ( 54 % ) decrease in limitations of daily living ( P < 0.01 ) , respectively . The overall tolerability of the orthoses was good ; no adverse effects were reported and the dropout rate with 7 % was rather low . Conclusions : The use of an orthosis increases trunk muscle strength and therefore improves posture in patients with vertebral fractures caused by osteoporosis . In addition , a better quality -of-life is achieved by pain reduction , decreased limitations of daily living , and improved well-being . Thereby , the use of an orthosis may represent an efficacious nonpharmacologic treatment option for spinal osteoporosis Pfeifer M , Begerow B , Minne HW : Effects of a new spinal orthosis on posture , trunk strength , and quality of life in women with postmenopausal osteoporosis : A r and omized trial . Am J Phys Med Rehabil 2004;83:177–186 . Objective One fourth of women ≥50 yrs of age in the general population have one or more vertebral fractures . The orthotic treatment modality in the management of vertebral fractures caused by osteoporosis remains subjective because no objective data from clinical trials are available . The objective of this research was to evaluate the efficacy of a newly developed spinal orthosis in patients with osteoporotic vertebral fractures . Design We conducted a study that measured trunk muscle strength , angle of kyphosis , body height , body sway , and variables of quality of life such as pain , well-being , and limitations of daily living . Results Wearing the orthosis for 6-mo period was associated with a 73 % increase in back extensor strength , a 5 \n Output:\n " }, { "from": "agent", "value": "A wide range of outcomes assessing impairments , activities and participation were assessed but the findings were mixed ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: PURPOSE To investigate the benefit of chemotherapy in patients with symptomatic hormone-resistant prostate cancer using relevant end points of palliation in a r and omized controlled trial . PATIENTS AND METHODS We r and omized 161 hormone-refractory patients with pain to receive mitoxantrone plus prednisone or prednisone alone ( 10 mg daily ) . Nonresponding patients on prednisone could receive mitoxantrone subsequently . The primary end point was a palliative response defined as a 2-point decrease in pain as assessed by a 6-point pain scale completed by patients ( or complete loss of pain if initially 1 + ) without an increase in analgesic medication and maintained for two consecutive evaluations at least 3 weeks apart . Secondary end points were a decrease of > or = 50 % in use of analgesic medication without an increase in pain , duration of response , and survival . Health-related quality of life was evaluated with a series of linear analog self- assessment scales ( LASA and the Prostate Cancer-Specific Quality -of-Life Instrument [ PROSQOLI ] ) , the core question naire of the European Organization for Research and Treatment of Cancer ( EORTC ) , and a disease-specific module . RESULTS Palliative response was observed in 23 of 80 patients ( 29 % ; 95 % confidence interval , 19 % to 40 % ) who received mitoxantrone plus prednisone , and in 10 of 81 patients ( 12 % ; 95 % confidence interval , 6 % to 22 % ) who received prednisone alone ( P = .01 ) . An additional seven patients in each group reduced analgesic medication > or = 50 % without an increase in pain . The duration of palliation was longer in patients who received chemotherapy ( median , 43 and 18 weeks ; P < .0001 , log-rank ) . Eleven of 50 patients r and omized to prednisone treatment responded after addition of mitoxantrone . There was no difference in overall survival . Treatment was well tolerated , except for five episodes of possible cardiac toxicity in 130 patients who received mitoxantrone . Most responding patients had an improvement in quality -of-life scales and a decrease in serum prostate-specific antigen ( PSA ) level . CONCLUSION Chemotherapy with mitoxantrone and prednisone provides palliation for some patients with symptomatic hormone-resistant prostate cancer BACKGROUND Enzalutamide ( formerly called MDV3100 ) targets multiple steps in the and rogen-receptor-signaling pathway , the major driver of prostate-cancer growth . We aim ed to evaluate whether enzalutamide prolongs survival in men with castration-resistant prostate cancer after chemotherapy . METHODS In our phase 3 , double-blind , placebo-controlled trial , we stratified 1199 men with castration-resistant prostate cancer after chemotherapy according to the Eastern Cooperative Oncology Group performance-status score and pain intensity . We r and omly assigned them , in a 2:1 ratio , to receive oral enzalutamide at a dose of 160 mg per day ( 800 patients ) or placebo ( 399 patients ) . The primary end point was overall survival . RESULTS The study was stopped after a planned interim analysis at the time of 520 deaths . The median overall survival was 18.4 months ( 95 % confidence interval [ CI ] , 17.3 to not yet reached ) in the enzalutamide group versus 13.6 months ( 95 % CI , 11.3 to 15.8 ) in the placebo group ( hazard ratio for death in the enzalutamide group , 0.63 ; 95 % CI , 0.53 to 0.75 ; P<0.001 ) . The superiority of enzalutamide over placebo was shown with respect to all secondary end points : the proportion of patients with a reduction in the prostate-specific antigen ( PSA ) level by 50 % or more ( 54 % vs. 2 % , P<0.001 ) , the soft-tissue response rate ( 29 % vs. 4 % , P<0.001 ) , the quality -of-life response rate ( 43 % vs. 18 % , P<0.001 ) , the time to PSA progression ( 8.3 vs. 3.0 months ; hazard ratio , 0.25 ; P<0.001 ) , radiographic progression-free survival ( 8.3 vs. 2.9 months ; hazard ratio , 0.40 ; P<0.001 ) , and the time to the first skeletal-related event ( 16.7 vs. 13.3 months ; hazard ratio , 0.69 ; P<0.001 ) . Rates of fatigue , diarrhea , and hot flashes were higher in the enzalutamide group . Seizures were reported in five patients ( 0.6 % ) receiving enzalutamide . CONCLUSIONS Enzalutamide significantly prolonged the survival of men with metastatic castration-resistant prostate cancer after chemotherapy . ( Funded by Medivation and Astellas Pharma Global Development ; AFFIRM Clinical Trials.gov number , NCT00974311 . ) BACKGROUND Mitoxantrone-based chemotherapy palliates pain without extending survival in men with progressive and rogen-independent prostate cancer . We compared docetaxel plus estramustine with mitoxantrone plus prednisone in men with metastatic , hormone-independent prostate cancer . METHODS We r and omly assigned 770 men to one of two treatments , each given in 21-day cycles : 280 mg of estramustine three times daily on days 1 through 5 , 60 mg of docetaxel per square meter of body-surface area on day 2 , and 60 mg of dexamethasone in three divided doses before docetaxel , or 12 mg of mitoxantrone per square meter on day 1 plus 5 mg of prednisone twice daily . The primary end point was overall survival ; secondary end points were progression-free survival , objective response rates , and post-treatment declines of at least 50 percent in serum prostate-specific antigen ( PSA ) levels . RESULTS Of 674 eligible patients , 338 were assigned to receive docetaxel and estramustine and 336 to receive mitoxantrone and prednisone . In an intention-to-treat analysis , the median overall survival was longer in the group given docetaxel and estramustine than in the group given mitoxantrone and prednisone ( 17.5 months vs. 15.6 months , P=0.02 by the log-rank test ) , and the corresponding hazard ratio for death was 0.80 ( 95 percent confidence interval , 0.67 to 0.97 ) . The median time to progression was 6.3 months in the group given docetaxel and estramustine and 3.2 months in the group given mitoxantrone and prednisone ( P<0.001 by the log-rank test ) . PSA declines of at least 50 percent occurred in 50 percent and 27 percent of patients , respectively ( P<0.001 ) , and objective tumor responses were observed in 17 percent and 11 percent of patients with bidimensionally measurable disease , respectively ( P=0.30 ) . Grade 3 or 4 neutropenic fevers ( P=0.01 ) , nausea and vomiting ( P<0.001 ) , and cardiovascular events ( P=0.001 ) were more common among patients receiving docetaxel and estramustine than among those receiving mitoxantrone and prednisone . Pain relief was similar in both groups . CONCLUSIONS The improvement in median survival of nearly two months with docetaxel and estramustine , as compared with mitoxantrone and prednisone , provides support for this approach in men with metastatic , and rogen-independent prostate cancer Purpose : With the approval of immunotherapies for a variety of indications , methods to assess treatment benefit addressing the response patterns observed are important . We evaluated RECIST criteria –based overall response rate ( ORR ) and progression-free survival ( PFS ) as potential surrogate endpoints of overall survival ( OS ) , and explored a modified definition of PFS by altering the threshold percentage determining disease progression to assess the association with survival benefit in immunotherapy trials . Experimental Design : Thirteen r and omized , multicenter , active-control trials containing immunotherapeutic agents su bmi tted to the FDA were analyzed . Associations between treatment effects of ORR , PFS , modified PFS , and OS were evaluated at individual and trial levels . Patient-level responder analysis was performed for PFS and OS . Results : The coefficient of determination ( R² ) measured the strength of associations , where values near 1 imply surrogacy and values close to 0 suggest no association . At the trial level , the association between hazard ratios ( HR ) of PFS and OS was R2 = 0.1303 , and between the odds ratio ( OR ) of ORR and HR of OS was R2 = 0.1277 . At the individual level , the Spearman rank correlation coefficient between PFS and OS was 0.61 . Trial-level associations between modified PFS and OS ranged between 0.07 and 0.1 , and individual-level correlations were approximately 0.6 . HRs of PFS and OS for responders versus nonresponders were 0.129 [ 95 % confidence interval ( CI ) , 0.11–0.15 ] and 0.118 ( 95 % CI , 0.11–0.13 ) , respectively . Conclusions : Although responders exhibited longer survival and PFS than nonresponders , the trial-level and individual-level associations were weak between PFS/ORR and OS . Modifications to PFS did not improve associations . Clin Cancer Res ; 24(10 ) ; 2268–75 . © 2018 AACR . See related commentary by Korn and Freidlin , p. PURPOSE To evaluate the efficacy and safety of atrasentan ( ABT-627 ) , an endothelin-A receptor antagonist , in the treatment of asymptomatic , hormone-refractory prostatic adenocarcinoma . PATIENTS AND METHODS A double-blind , r and omized , placebo-controlled clinical trial of hormone-refractory prostate cancer ( HRPCa ) patients was conducted in the United States and Europe . Two hundred eighty-eight asymptomatic patients with HRPCa and evidence of metastatic disease were r and omly assigned to one of three study groups receiving a once-daily oral dose of placebo , 2.5 mg atrasentan , or 10 mg atrasentan , respectively . Primary end point was time to progression ; secondary end points included time to prostate-specific antigen ( PSA ) progression , bone scan changes , and changes in bone and tumor markers . RESULTS The three treatment groups were similar in all baseline characteristics . Median time to progression in intent-to-treat ( ITT ) patients ( n = 288 ) was longer in the 10-mg atrasentan group compared with the placebo group : 183 v 137 days , respectively ; ( P = .13 ) . Median time to progression in evaluable patients ( n = 244 ) was significantly prolonged , from 129 days ( placebo group ) to 196 days ( 10-mg atrasentan group ; P = .021 ) . For both ITT and evaluable population s in the 10-mg atrasentan group , median time to PSA progression was twice that of the placebo group ( 155 v 71 days ; P = .002 ) . Patients who received placebo continued to have significant increases from baseline in serum ( lactate dehydrogenase [ LDH ] ) , a marker of disease burden ; elevations in LDH were uniformly attenuated by atrasentan in the ITT population . Headache , peripheral edema , and rhinitis were primary side effects , typically of mild to moderate severity . Quality of life was not adversely affected by atrasentan . CONCLUSION Atrasentan is an oral , targeted therapy with favorable tolerability and the potential to delay progression of HRPCa BACKGROUND The alpha-emitter radium-223 ( (223)Ra ) is a bone-seeking radionuclide studied as a new treatment for patients with bone metastases from hormone-refractory prostate cancer . We aim ed to study mature outcomes from a r and omised , multicentre , phase II study of (223)Ra . METHODS Patients with hormone-refractory prostate cancer and bone pain needing external-beam radiotherapy were assigned to four intravenous injections of (223)Ra ( 50 kBq/kg , 33 patients ) or placebo ( 31 patients ) , given every 4 weeks . Primary endpoints were change in bone-alkaline phosphatase ( ALP ) concentration and time to skeletal-related events ( SREs ) . Secondary endpoints included toxic effects , time to prostate-specific-antigen ( PSA ) progression , and overall survival . All tests were done at a 5 % significance level , based on intention to treat . FINDINGS Median relative change in bone-ALP during treatment was -65.6 % ( 95 % CI -69.5 to -57.7 ) and 9.3 % ( 3.8 - 60.9 ) in the (223)Ra group and placebo groups , respectively ( p<0.0001 , Wil \n Output:\n " }, { "from": "agent", "value": "Measurable tumor responses in phase 2 trials were higher for successful therapies in phase 3 trials in chemotherapy-naive men with mCRPC , but were less correlated with success in trials investigating docetaxel combination regimens or the post chemotherapy mCRPC setting .\nMany failed agents did not produce higher than expected response rates over control arms ; however , several agents such as anti-angiogenic therapies or orteronel produced higher than expected responses without survival benefit .\nConclusions Objective responses in men with mCRPC may be associated with prolonged survival , but this association is mechanism dependent and inconsistent across trials or disease states ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: We tested the hypothesis that active and passive airway humidification minimize hypothermia in infants , but that maintaining normothermia does not decrease the duration of postoperative recovery . A circle system was used to ventilate the lungs of anesthetized , intubated infants who were r and omly assigned to active airway humidification and warming with use of an MR450 Servo airway heater and humidifier set at 37 ° C ( n = 10 ) , passive airway humidification with use of the Humid-Vent Mini heat and moisture exchanger placed between the Y-piece of the circle and the endotracheal tube ( n = 10 ) , or no airway humidification and heating ( control , n = 10 ) . Anesthesia was induced with thiopental and maintained with isoflurane and nitrous oxide in oxygen . The relative humidity of inspired respiratory gases was ∼35 % in the control group and ∼90 % in the group undergoing active airway humidification . Initial inspired humidity in the passive humidification group ( 45 % ) increased to ∼80 % after 1 h of anesthesia . Humidity differed significantly across groups at all times ( P ≤ 0.05 ) . Steady-state rectal temperatures ( 100 - -120 min after induction ) were 36.2 ± 0.7 ° C in patients given active humidification and heating , 35.7 ± 0.9 ° C in the passively humidified group , and 35.2 ± 0.4 ° C in the control group ( P ≤ 0.05 between each group ) . Recovery from general anesthesia was rapid in all patients and did not correlate with central temperature changes or type of humidification ( P = NS ) . We conclude that heat and moisture exchangers are less effective than active heating and humidification , but significantly better than no humidification BACKGROUND The purpose of this study was to compare the performance of heat and moisture exchanger filters with heated humidifying systems in the mechanical ventilator circuit on the incidence of ventilator-associated pneumonia ( VAP ) and bacterial colonization . METHOD Two hundred and forty-three consecutive patients who required mechanical ventilation for 48 hours or more in the adult intensive care unit were r and omized to either a heat and moisture exchanger ( HME ) or a heated humidifying breathing circuit . RESULTS The VAP rate among the group with HME was 11.4 % ; the rate among the group with heated humidifying system ( HHS ) was 15.8 % . The difference was not statistically significant . Approximately 68 % of the patients in the HME group had no pathogen isolated compared with 50 % of the patients in the HHS group . This difference was statistically significant ( P = .006 ) . However , the distribution of the pathogens among those patients who had the isolated pathogens was mostly identical in the 2 groups . CONCLUSION Even though the study did not find HME to be significantly advantageous over the HHS , in as much as VAP rate is concerned , other advantages such as reduced nurses workload , reduced financial cost , and better safety made HME a more favorable device for use in our adult intensive care unit STUDY OBJECTIVE Determine the utility of a proposed algorithm in allowing safe , efficient humidification in mechanically ventilated patients using both a hygroscopic condenser humidifier ( HCH ) and heated humidifier ( HH ) . DESIGN A prospect i ve study using an algorithm to chose humidification devices based on physical examination and sputum characteristics . SETTING All patients admitted to the surgical ICU . PATIENTS One hundred twenty consecutive patients requiring mechanical ventilation ( MV ) were studied . INTERVENTIONS Patients were examined by the attending respiratory care practitioner and given either an HCH or HH . If patients demonstrated any of the following -- thick or tenacious secretions , core temperature < 32 degrees C , or bloody secretions -- they were given an HH . All others used an HCH . If any of the above conditions occurred during HCH use , the patient was given an HH . MEASUREMENTS AND RESULTS Duration of ventilation , incidence of nosocomial pneumonia , ventilator circuit colonization , and mortality were determined for patients in each group . Cost of humidification devices , number of suctioning procedures per day , and volume of saline solution instilled were also recorded . Initially , 27 percent ( 32/120 ) of patients used an HH and 73 percent ( 88/120 ) used an HCH . During the study , ten patients required changing to an HH during HCH use . Patients in the HH group were more likely to have preexisting lung disease and had a longer duration of ventilation ( 83 + /- 21 h ) and higher mortality ( 21 percent ) . Patients in the HCH group were more likely to be postoperative , had shorter duration s of ventilation ( 38 + /- 14 h ) , and lower mortality ( 9 percent ) . There was no difference in the incidence of nosocomial pneumonia between the two groups ( 9 percent vs 6 percent ) and endotracheal tube occlusion did not occur in either group . Circuit colonization was common in the HH group ( 64 percent ) but rate in the HCH group ( 5 percent ) . Cost per day was significantly less for the HCH group ( $ 4 vs $ 19.80 ) . Patients who required a change from HCH to HH did so at a mean of 5 days . CONCLUSION The proposed algorithm result ed in cost-efficient and safe application of humidification devices in patients in the surgical ICU Critically ill patients in the intensive care unit ( ICU ) are at high risk for infections associated with increased morbidity , mortality , and health care costs ( 1 - 3 ) . The overall infection rate in critically ill patients approaches 40 % and may be as high as 50 % or 60 % in patients who remain in the ICU for more than 5 days ( 4 , 5 ) . Respiratory tract infections account for 30 % to 60 % of all such infections . The incidence of pneumonia acquired in the ICU ranges from 10 % to 65 % ( 6 - 11 ) . Among patients at high risk for ventilator-associated pneumonia ( VAP ) are those who have chronic obstructive pulmonary disease , burns , neurosurgical conditions , the acute respiratory distress syndrome , and witnessed aspiration ; those who are reintubated ; and those who receive paralytic agents or enteral nutrition ( 12 , 13 ) . The attributable morbidity and mortality of VAP are clinical ly important . In a prospect i ve , matched cohort study , patients with VAP remained in the ICU 4.3 days ( 95 % CI , 1.5 to 7.0 days ) longer than patients who did not have VAP and had a trend toward an increased risk for death ( absolute risk increase , 5.8 % [ CI , 2.4 % to 14.0 % ] ) ( 14 ) . Six other studies using a matching strategy found a prolonged length of ICU stay associated with VAP ( range , 5 to 13 days ) and attributable mortality ranging from an absolute risk increase of 0 % to 50 % ( 15 - 20 ) . Therefore , strategies to decrease the incidence of VAP could decrease morbidity , mortality , and health care costs and improve patient safety . A survey of the use of VAP prevention strategies identified differences across countries ( 21 ) . For example , changing the ventilator circuit for each new patient was reported more frequently by French ICU directors than those in Canada ( 21 ) . This survey also showed that some effective strategies were used infrequently , suggesting inadequate translation of r and omized trial results into practice . One potential catalyst for knowledge translation is an evidence -based clinical practice guideline . Therefore , a Joint Planning Group of the Canadian Critical Care Society and Canadian Critical Care Trials Group commissioned the development of an evidence -based clinical practice guideline for the prevention of VAP . In this paper , we describe the methods used to create the guideline and the recommendations generated . Methods The Joint Planning Group selected an 11-member VAP Prevention Guideline Panel made up of 9 intensivists from university-affiliated and community hospitals , an ICU nurse , and an ICU respiratory therapist . Panel members were experts in critical care medicine ( n= 9 ) , VAP ( n= 4 ) , evidence -based medicine ( n= 4 ) , and guideline development ( n= 3 ) . The context was mechanically ventilated adult patients cared for in the ICU . The target audience was ICU clinicians in university-affiliated and community hospitals . To identify potentially relevant evidence , we search ed 3 bibliographic data bases ( MEDLINE , EMBASE , and the Cochrane Data base of Systematic Review s ) to 1 April 2003 for r and omized trials that evaluated interventions influencing VAP ( Appendix ) . We had no language restrictions . We also review ed personal files and practice guidelines on this subject previously published by the Centers for Disease Control and Prevention ( 22 ) and the American Thoracic Society ( 23 ) . We included r and omized trials and systematic review s of r and omized trials that 1 ) studied adult critically ill patients ; 2 ) had VAP as an outcome ; and 3 ) evaluated any of the following interventions : physical strategies ( route of endotracheal intubation , systematic search for maxillary sinusitis , frequency of ventilator circuit changes , type of airway humidification , frequency of humidifier changes , endotracheal suctioning system , subglottic secretion drainage , chest physiotherapy , and tracheostomy timing ) , positional strategies ( kinetic beds , semi-recumbent positioning , and prone positioning ) , and pharmacologic strategies ( stress ulcer prophylaxis and prophylactic antibiotics , including selective decontamination of the digestive tract ) . Since study authors used various definitions of VAP , we used the definitions they provided . The most common definition was a new or persistent radiographic infiltrate plus fever , leukocytosis , change in the volume or color of sputum , or isolation of a pathogen . If available , histologic evidence of pneumonia was also used . A priori , we decided to review only systematic review s of r and omized clinical trials for antibiotic prophylaxis and only r and omized clinical trials for all other topics . We excluded crossover and beforeafter studies . We also excluded r and omized trials of ventilator weaning , including noninvasive mechanical ventilation , and nutritional interventions evaluating VAP because guidelines addressing these topics have recently been published ( 24 , 25 ) . In duplicate and independently , 3 pairs of panel members critically appraised each trial ( 26 , 27 ) and systematic review ( 28 ) . Each member of a pair compared his or her independent appraisal of a given trial or systematic review with that of the other member of the pair . For each r and omized trial , we abstract ed sample , allocation , intervention , co- interventions , exclusions after r and omization , blinding of outcome assessment , definition of VAP , crude VAP events , relative risk for VAP , and other outcomes . For each intervention , we summarized the risk differences and calculated a pooled risk difference . For each systematic review , we abstract ed number of trials , population , intervention , selection criteria , search strategy , validity assessment , method of pooling results , homogeneity assessment , VAP definition , pooled event rates , and other outcomes . Before the panel meeting , each pair of appraisers achieved consensus on the validity and results of the trials they review ed . One month before the panel meeting , panel members received the evidence tables for review prepared by the 3 pairs of appraisers . A priori , panel members agreed to read all circulated documents and evidence tables in advance , to use levels of evidence to generate a status statement for each item , and to abide by the group process and consensus methods . The Canadian Critical Care Society appointed a chair to ensure that the panel achieved its objectives through group process ( 29 ) . At the panel meeting , each member recorded any potential conflicts of interest ( 30 ) . The pair of panel members responsible for critical appraisal of each intervention provided a structured written and oral presentation of the evidence . After the panel discussion , the initial evidence summary was revised if necessary . The panel members assigned levels of evidence , semi-quantitative scores to summarize the evidence and describe the intervention , and a status statement . We classified trials as level 1 if they had all of the following : concealed r and omization , blinded outcome adjudication , an intention-to-treat analysis , and an explicit definition of VAP . Trials were classified as level 2 if any one of these characteristics was unfulfilled and as level 3 if allocation was not strictly r and omized . We used a semi-quantitative score ( 0 , 1 , 2 , or 3 ) to evaluate each intervention with respect to the validity of the r and omized trials ; the effect size of each intervention ; the confidence intervals around the estimate of effect ; the homogeneity of the trial results ; and the safety , feasibility , and economic consequences of the intervention . The language of the status statement for each item was keyed to the levels of evidence and the semi-quantitative scores . We used the term recommended if there were no reservations about endorsing an intervention and the term considered if the evidence supported an intervention but there were minor uncertainties about the benefits , harms , or costs . No recommendation was made if evidence regarding an intervention was inadequate or if there were major uncertainties about the benefits , harms , or costs . After the panel meeting , the chair compiled the summaries and status statements and sent them to all panel members to check accuracy and clarity . In addition , the pairs of evidence appraisers wrote background documents for the interventions they appraised , including the rationale for each intervention , appraisal of r and omized trials and systematic review s , and harms and costs of the interventions . The chair and the writing committee organized the background documents , the evidence summaries , a table of the semi-quantitative scores , and the status statement for each \n Output:\n " }, { "from": "agent", "value": "There was no overall effect on artificial airway occlusion , mortality , pneumonia , or respiratory complications ; however , the PaCO(2 ) and minute ventilation were increased when HMEs were compared to HHs and body temperature was lower .\nThe cost of HMEs was lower in all studies that reported this outcome .\nThere was some evidence that hydrophobic HMEs may reduce the risk of pneumonia and that blockages of artificial airways may be increased with the use of HMEs in certain subgroups of patients .\nThere is little evidence of an overall difference between HMEs and HHs .\nHowever , hydrophobic HMEs may reduce the risk of pneumonia and the use of an HME may increase artificial airway occlusion in certain subgroups of patients .\nTherefore , HMEs may not be suitable for patients with limited respiratory reserve or prone to airway blockage ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background The success of in vitro fertilization techniques is defined by multiple factors including embryo culture conditions , related to the composition of the culture medium . In view of the lack of solid scientific data and in view of the current general belief that sequential media are superior to single media , the aim of this r and omized study was to compare the embryo quality in two types of culture media . Methods In this study , the embryo quality on day 3 was measured as primary outcome . In total , 147 patients younger than 36 years treated with IVF/ICSI during the first or second cycle were included in this study . Embryos were r and omly cultured in a sequential ( group A ) or a single medium ( group B ) to compare the embryo quality on day 1 , day 2 and day 3 . The embryo quality was compared in both groups using a Chi-square test with a significance level of 0.05 . Results At day 1 , the percentage of embryos with a cytoplasmic halo was higher in group B ( 46 % ) than in group A ( 32 % ) . At day 2 , number of blastomeres , degree of fragmentation and the percentage of unequally sized blastomeres were higher in group B than in group A. At day 3 , a higher percentage of embryos had a higher number of blastomeres and unequally sized blastomeres in group B. The number of good quality embryos ( GQE ) was comparable in both groups . The embryo utilization rate was higher in group B ( 56 % ) compared to group A ( 49 % ) . Conclusions Although , no significant difference in the number of GQE was found in both media , the utilization rate was significantly higher when the embryos were cultured in the single medium compared to the sequential medium . The results of this study have a possible positive effect on the cumulative cryo-augmented pregnancy rate . Trial registration BACKGROUND Optimal culture conditions are crucial for embryonic development and blastocyst formation after in vitro fertilization ( IVF ) or Intracytoplasmic sperm injection ( ICSI ) . A prospect i ve r and omized trial was carried out to compare the effects of two different sequential media ( Vitrolife and MediCult ) on embryo development and implantation . MATERIAL / METHODS 176 couples were included in this prospect i ve r and omized study . All couples undergoing the IVF ( n=84 ) or ICSI ( n=92 ) program at the University of Würzburg were r and omly assigned to either Vitrolife ( n=87 ) or MediCult ( n=89 ) sequential culture media . RESULTS The overall median fertilization rate ( FR ) was 84.0 % and was similar in the Vitrolife ( FR=87.5 % ) and MediCult group ( FR=80.0 % ) . A mean of 2.7 embryos were replaced into the uterus , not significantly different between both groups . The pronuclear development was significantly enhanced in embryos cultured in Vitrolife than in those cultured in MediCult media ( p=0.035 ) . The embryonic development on day 3 was also superior in the Vitrolife group , but only in ICSI cycles ( p<0.01 ) . After 5 days of culturing , the blastocyst development was equivalent in both groups . The clinical pregnancy rate was 31.0 % per transfer in the Vitrolife group and 28.1 % in the MediCult group ( not significant ) . CONCLUSIONS The results demonstrate that implantation and clinical pregnancy rates with both media are comparable . Embryonic development until day three seemed to be enhanced when the embryos were cultured in Vitrolife media Aim of the study : Pilot study to analyse the efficacy and embryo morphology using a new human embryo culture medium ( GM501 ) versus the conventional used medium ( ISM1 ) . Methods : Over a four-month period , all patients at the Leuven Institute of Fertility and Embryology ( LIFE ) were r and omly allocated to have their embryos cultured in either the st and ard sequential culture medium ISM1 ( control ) or in a new universal medium ( GM501 ) ( study group ) . Primary outcome parameters were clinical pregnancy and live birth rate . The secondary outcome parameter was the correlation of embryo fragmentation rate with pregnancy outcome . Results : We did not observe any differences between the ISM1 control group and GM501 study group with regard to fertilization , pregnancy , implantation rates , ongoing pregnancy , and babies born . The number of embryos with a minimal fragmentation rate ( less than 30 % ) was significantly higher in the GM501 study group . Conclusion : Although a significant higher embryo fragmentation rate was seen in In vitro culture of embryos in GM501 , pregnancy outcome results were comparable to those of embryos cultured in ISM1 . According to our results the value of embryo morphological criteria as a parameter for pregnancy outcome should be examined and discussed again BACKGROUND We aim ed to examine the efficacy of using an embryo transfer medium enriched with hyaluronan ( HA ) to improve implantation in a selected group of patients aged < 43 years with repeated ( > 4 ) implantation failures after IVF-embryo transfer . METHODS About 101 patients , meeting our selection criteria , were r and omly allocated to undergo embryo transfer either using our routine embryo transfer medium without HA ( control group ) or a HA enriched commercial embryo transfer medium ( study group ) . The primary outcome was clinical pregnancy rate . RESULTS After a similar treatment protocol , the ovarian hormonal response , the mean number of ova retrieved and injected per patient , fertilization and cleavage rates and mean embryo quality were comparable between the study and control groups . Although a similar number of embryos was transferred in both groups ( 3.1 + /- 0.7 versus 2.9 + /- 0.6 , mean + /- SD ) , a significantly higher implantation rate ( 16.3 % versus 4.8 % , P = 0.002 ) and clinical pregnancy rate ( 35.2 % versus 10.0 % , P = 0.004 ) and delivered or ongoing pregnancy rate ( 31.3 % versus 4.0 % , P = 0.0005 ) were observed in the study group . When mean implantation rate per patient was calculated , the difference between the study ( 0.148 + /- 0.23 ) and control ( 0.04 + /- 0.13 ) group was significant ( P = 0.003 ) . CONCLUSIONS In this selected group of patients after multiple IVF-embryo transfer failures , the use of HA enriched embryo transfer medium is beneficial Abstract Purpose : The aim of this prospect i ve , r and omized study was to compare the results obtained in ICSI with two culture media , P-1 ( Irvine Scientific ) and IVF-50 ( Sc and inavian IVF Science ) . Methods : A total of 182 patients undergoing ICSI treatment were r and omly included in this study and divided in two groups : Group I : P-1 medium ( n = 91 ) or Group II : IVF-50 medium ( n = 91 ) . All the embryos were transferred on the second day . Results : Patient age did not differ ( p = .29 ) between Group I ( 34.8 ± 4.8 ) and Group II ( 34.0 ± 4.5 ) . The number of oocytes retrieved from Group I ( 10.6 ± 6.7 ) was also similar ( p = .49 ) to that retrieved from Group II ( 11.1 ± 6.4 ) . In addition , there was no difference ( p = .25 ) in the number of oocytes retrieved at metaphase II between Group I ( 7.9 ± 4.6 ) and Group II ( 8.7 ± 4.6 ) . Normal fertilization rates , abnormal fertilization rates , and cleavage rates were similar ( p = .62 , p = .48 , and p = .9 , respectively ) between Group I ( 68.4 ± 23.3 % , 6.7 ± 10.3 % , and 98.7 ±4.6 % ) and Group II ( 65.3 ± 26.2 % , 9.0 ± 13.8 % , and 98.9 ± 3.9 % , respectively ) . The embryo score was also similar ( p = .62 ) for both groups ( Group I : 31.9 ± 14.0 and Group II : 33.4 ± 15.8 ) . There was no difference in the number of embryos transferred ( p = .69 ) between Group I ( 2.8 ± 1.0 ) and Group II ( 2.8 ± 1.1 ) . In addition , pregnancy rates/puncture , pregnancy rates/transfer , implantation rates , and abortion rates were also similar for Group I ( 36.2 % , 37.0 % , 17.4 % , and 12.1 % , respectively ) and Group II ( 31.8 % , 33.7 % , 15.8 % , and 10.3 % , respectively ) ( p = .64 , p = .75 , p = .72 , and p = 1.0 , respectively ) . Conclusions : There were no differences in the results obtained with culture media P-1 ( Irvine Scientific ) and IVF-50 ( Sc and inavian IVF Science ) for ICSI and embryo culture This study was undertaken to compare the outcome of day 3 , day 5 , and frozen-thawed embryo transfer cycles where embryo culture was undertaken using the G1.2-G2.2 versus GIII series sequential media . A total of 400 day 3 , 73 day 5 and 126 frozen-thawed embryo transfer cycles were analysed . Treatment cycles were quasi-r and omized on the day of oocyte retrieval to embryo culture in G1.2-G2.2 versus GIII series sequential media . R and omization was undertaken according to alternating weekdays . Significantly more embryos were of grade 1 or 2 quality on day 3 in the GIII group ( P < 0.05 ) . Likewise , more embryos in the GIII group had eight blastomeres on day 3 ( P < 0.05 ) and were able to hatch spontaneously ( P < 0.05 ) . For day 3 embryo transfer cycles , implantation and clinical pregnancy rates were 14.4 and 25.7 % versus 37.8 and 50.3 % in G1.2-G2.2 and GIII groups respectively ( P < 0.05 ) . For day 5 embryo transfer cycles , implantation rates were significantly higher ( 29 versus 45 % ; P < 0.05 ) in the GIII group . There was a trend towards higher pregnancy rates ; however , this did not reach statistical significance due to fewer cycles analysed in this group . In-vitro culture in GIII series sequential media yields better quality embryos that implant more efficiently , compared with culture in G1.2-G2.2 media Since the metabolic requirements of fertilization and early embryonic development are very different , we have tested a new culture medium ( EllioStep2 , Ellios Bio-Media , Paris , France ) specially design ed for the first cleavages and compared it with two conventional media : BM1 ( Ellios Bio-Media , Paris , France ) and IVF50 ( Sc and inavian IVF Science , Gothenburg , Sweden ) . In order to avoid any interference with fertilization , the test was performed as part of an intracytoplasmic sperm injection ( ICSI ) study . A total of 416 ICSI attempts were r and omly performed using one or other of the media . After sperm injection , oocytes were incubated either in EllioStep2 or in BM1 or in IVF50 . The embryo quality , pregnancy and implantation rates , number of frozen embryos were compared in the different media . The percentage of fair embryos ( grade s 4 and 3 ) was significantly higher when EllioStep2 was used than when oocytes was cultured in BM1 medium ( 54 versus 47 % ; P < 0.01 ) or in IVF50 ( 69 versus 61 % ; P < 0.01 ) . The pregnancy rate per transfer and the implantation rate were not significantly higher with EllioStep2 than with BM1 or IVF50 . However , the percentage of embryo freezings per attempt was significantly higher with EllioStep2 than with BM1 ( 47/105 versus 28/105 ; P < 0.01 ) . In conclusion , the use of EllioStep2 is associated with an increase in embryo quality permitting a higher number of embryo freezings Purpose : Our purpose wax to evaluate the efficiency of a medium , devoid of any human or animal compound and specially design ed for early embryo development ( from the zygote to the eight-cell stage ) , SMART2 , in intracytoplasmic sperm injection ( ICSI ) and to compare it with a medium containing human serum albumin ( EllioStep2 ) . Methods : Oocytes from 50 ICSI attempts were r and omly placed , after sperm injection , into either SMART2 or EllioStep2 . After a 48-hr incubation , the embryos were examined for quality scoring before transfer or freezing . Results : The percentage of normally fertilized oocytes per intact oocytes was slightly higher using SMART2 ( 139/199 vs. 135/224 , respectively , for SMART2 and EllioStep2 : P < 0.05 ) . The distribution of embryo scores and the percentage of embryos with a fair morphology ( 71/143 vs. 72/148 , respectively , for SMART2 and EllioStep2 ; not significant ) were identical in both media . Conclusions : These data show that SMART2 medium can be \n Output:\n " }, { "from": "agent", "value": "It is yet unknown what culture medium leads to the best success rates in IVF/ICSI ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: INTRODUCTION Chronic kidney disease ( CKD ) is an independent cardiovascular risk factor . The knowledge of prevalence in general population may help to early detection of CKD and prevent or delay its progression . METHODS Sociodemographic , baseline characteristics , and CKD prevalence ( measured by central ized serum creatinine and MDRD equation ) were evaluated in a r and omly selected sample of general population aged 20 years or older , collected in all Spanish regions and stratified by habitat , age and sex according to 2001 census ( n=2746 ) . Univariate and multivariate logistic regression analyses were used to evaluate associations with CKD risk factors . RESULTS Mean age was 49.5 years . The overall prevalence of Kidney Disease Outcomes Quality Initiative grade s 3 - 5 CKD was 6.8 % , with a 95 % confidence interval ( CI ) of 5.4 to 8.2 ( 3.3 % for age 40 - 64 years and 21.4 % for age > 64 years ) . The prevalence estimates of CKD stages were : 0.99 % for stage 1 ( glomerular filtration rate [ GFR ] > or=90 ml/min per 1.73 m2 with proteinuria ) ; 1.3 % for stage 2 ( GFR 60 - 89 ) ; 5.4 % for stage 3a ( GFR 45 - 59 ) ; 1.1 % for stage 3b ( GFR 30 - 44 ) ; 0.27 % for stage 4 ( GFR 15 - 29 ) ; and 0.03 % for stage 5 ( GFR < 15 ) . An important prevalence of classical cardiovascular risk factors was observed : dyslipemia ( 29.3 % ) , obesity ( 26.1 % ) , hypertension ( 24.1 % ) , diabetes ( 9.2 % ) and current smoking ( 25.5 % ) . The independent predictor factors for CKD were age , obesity and previously diagnosed hypertension . CONCLUSION The prevalence of CKD at any stage in general population from Spain is relatively high , especially in the elderly , and similar to countries of the same geographical area . Independently of age , two modifiable risks factors , hypertension and obesity , are associated with an increased prevalence of CKD Background . The prognostic value of reduced glomerular filtration rate ( GFR ) was examined in a community-based cohort of British women . Methods . Serum creatinine measurements were available for 90 % ( n = 3851 ) of a representative r and om sample of 4286 women aged 60 - 79 years . GFR was estimated using the Modification of Diet in Renal Disease equation . Hazard ratios ( HR ) were calculated using Cox regression with outcomes of all-cause and cardiovascular disease ( CVD ) mortality . Results . Eight hundred and thirty-two women ( 21.6 % ) had a GFR < 60 ml/min/1.73 m(2 ) . Over a median follow-up of 5.6 years , there were 318 deaths ( 100 CVD deaths ) . Women with GFR < 60 ml/min/1.73 m(2 ) compared to all others showed only a borderline increased risk of all-cause mortality [ HR 1.35 ( 95 % confidence intervals : 0.99 , 1.85 ) ] and CVD mortality [ 1.34 ( 0.97 , 1.85 ) ] . Adjustment for conventional CVD risk factors had little impact . The association with CVD mortality was attenuated in women with pre-existing CVD [ adjusted HR : 0.51 ( 0.24 , 1.04 ) ] . Only the subset of women without CVD at baseline were at risk for later CVD death [ adjusted HR : 1.80 ( 1.13 , 2.88 ) ] . Conclusions . A substantial proportion of older British women have GFR < 60 ml/min/1.73 m(2 ) without strong evidence for statistical association with all-cause mortality . The effect on CVD mortality is partly explained by existing CVD and its risk factors . GFR measurement appears only to play a useful role in the subset of older women without pre-existing CVD who are at higher risk of premature CVD death BACKGROUND In older adults , current equations to estimate glomerular filtration rate ( GFR ) are not vali date d and may misclassify elderly persons in terms of their stage of chronic kidney disease . OBJECTIVE To derive the Berlin Initiative Study ( BIS ) equation , a novel estimator of GFR in elderly participants . DESIGN Cross-sectional . Data were split for analysis into 2 sets for equation development and internal validation . SETTING R and om community-based population of a large insurance company . PARTICIPANTS 610 participants aged 70 years or older ( mean age , 78.5 years ) . INTERVENTION Iohexol plasma clearance measurement as gold st and ard . MEASUREMENTS GFR , measured as the plasma clearance of the endogenous marker iohexol , to compare performance of existing equations of estimated GFR with measured GFR of the gold st and ard ; estimation of measured GFR from st and ardized creatinine and cystatin C levels , sex , and age in the learning sample ; and comparison of the BIS equations ( BIS1 : creatinine-based ; BIS2 : creatinine- and cystatin C-based ) with other estimating equations and determination of bias , precision , and accuracy in the validation sample . RESULTS The new BIS2 equation yielded the smallest bias followed by the creatinine-based BIS1 and Cockcroft-Gault equations . All other equations considerably overestimated GFR . The BIS equations confirmed a high prevalence of persons older than 70 years with a GFR less than 60 mL/min per 1.73 m2 ( BIS1 , 50.4 % ; BIS2 , 47.4 % ; measured GFR , 47.9 % ) . The total misclassification rate for this criterion was smallest for the BIS2 equation ( 11.6 % ) , followed by the cystatin C equation 2 ( 15.1 % ) proposed by the Chronic Kidney Disease Epidemiology Collaboration . Among the creatinine-based equations , BIS1 had the smallest misclassification rate ( 17.2 % ) , followed by the Chronic Kidney Disease Epidemiology Collaboration equation ( 20.4 % ) . LIMITATION There was no validation by an external data set . CONCLUSION The BIS2 equation should be used to estimate GFR in persons aged 70 years or older with normal or mild to moderately reduced kidney function . If cystatin C is not available , the BIS1 equation is an acceptable alternative . PRIMARY FUNDING SOURCE Kuratorium für Dialyse und Nierentransplatation ( KfH ) Foundation of Preventive Medicine Background The prevalence of chronic kidney disease ( CKD ) using available estimating equations with the Republic of Irel and is unknown . Methods A r and omly selected population based cross-sectional study of 1,098 adults aged 45 years and older was conducted using data from the 2007 Survey of Lifestyle , Attitudes and Nutrition ( SLÁN ) . Estimated Glomerular Filtration Rate ( eGFR ) was calculated from a single IDMS aligned serum creatinine using the CKD-EPI and the MDRD equations , and albumin to creatinine ratio was based on a single r and om urine sample . Results The sample clinical characteristics and demography was similar to middle and older age adults in the general Irish population , though with an underrepresentation of subjects > 75 years and of males . All results are based on subjects with available blood and urine sample s. Applying weighting to obtain survey based population estimates , using Irish population census data , the estimated weighted prevalence of CKD-EPI eGFR<60 mL/min/1.73m2 was 11.6 % , ( 95 % confidence interval ; 9.0 , 14.2 % ) , 12.0 % ( 9.0 , 14.2 % ) of men and 11.2 % ( 7.3 , 15.2 % ) of women . Unweighted prevalence estimates were similar at 11.8 % ( 9.9 , 13.8 % ) . Albuminuria increased with lower CKD-EPI eGFR category . 10.1 % of all subjects had albuminuria and an eGFR≥60 mL/min/1.73 m2 giving an overall weighted estimated prevalence of National Kidney Foundation ( NKF ) defined CKD 21.3 % ( 18.0 , 24.6 % ) , with the unadjusted estimate of 21.9 % ( 19.5 , 24.4 % ) . MDRD related estimates for eGFR < 60 mL/min/1.73 m2 , and NFK defined CKD were higher than CKD-EPI and differences were greater in younger and female subjects . Conclusions CKD is highly prevalent in middle and older aged adults within the Republic of Irel and . In this population , there is poor agreement between CKD-EPI and MDRD equations especially at higher GFRs . CKD is associated with lower educational status and poor self rated health BACKGROUND We investigate whether the urinary proteome refines the diagnosis of renal dysfunction , which affects over 10 % of the adult population . METHODS We measured serum creatinine , estimated glomerular filtration rate ( eGFR ) and 24-h albuminuria in 797 people r and omly recruited from a population . We applied capillary electrophoresis coupled with mass spectrometry to measure multi-dimensional urinary proteomic classifiers developed for renal dysfunction ( CKD273 ) or left ventricular dysfunction ( HF1 and HF2 ) . Renal function was followed up in 621 participants and the incidence of cardiovascular events in the whole study population . RESULTS In multivariable-adjusted cross-sectional analyses , higher biomarker levels analysed separately or combined by principal component analysis into a single factor ( SF ) , correlated ( P ≤ 0.010 ) with worse renal function . Over 4.8 years , higher HF1 and SF predicted ( P ≤ 0.014 ) lowering of eGFR ; higher HF2 predicted ( P ≤ 0.049 ) increase in serum creatinine and decrease eGFR . HF1 , HF2 and SF predicted progression from CKD Stages 2 or ≤2 to Stage ≥3 , with risk estimates for a 1-SD increment in the urinary biomarkers ranging from 38 to 71 % ( P ≤ 0.039 ) . HF1 , HF2 and SF yielded a net reclassification improvement of 31 - 51 % ( P ≤ 0.029 ) . Over 6.1 years , 47 cardiovascular events occurred . HF2 and SF , independent of baseline eGFR , 24-h albuminuria and other covariables were significant predictors of cardiovascular complications with risk estimates for 1-SD increases ranging from 32 to 41 % ( P ≤ 0.047 ) . CONCLUSIONS The urinary proteome refines the diagnosis of existing or progressing renal dysfunction and predicts cardiovascular complications Background Increasing evidence suggests a mechanistic link between the glycemic environment and renal and cardiovascular events , even below the threshold for diabetes . We aim ed to assess the association between HbA1c and chronic kidney disease ( CKD ) and cardiovascular disease ( CVD ) . Methods A cross-sectional study involving a r and om representative sample of 2270 adults from southern Spain ( Malaga ) was undertaken . We measured HbA1c , serum creatinine and albuminuria in fasting blood and urine sample s. Results Individuals without diabetes in the upper HbA1c tertile had an unfavorable cardiovascular and renal profile and shared certain clinical characteristics with the patients with diabetes . Overall , a higher HbA1c concentration was strongly associated with CKD or CVD after adjustment for traditional risk factors . The patients with known diabetes had a 2-fold higher odds of CKD or CVD . However , when both parameters were introduced in the same model , the HbA1c concentration was only significantly associated with clinical endpoints ( OR : 1.4 , 95 % CI , 1.1 - 1.6 , P = 0.002 ) . An increase in HbA1c of one percentage point was associated with a 30 % to 40 % increase in the rate of CKD or CVD . This relationship was apparent in persons with and without known diabetes . ROC curves illustrated that a HbA1c of 37 mmol/mol ( 5.5 % ) was the optimal value in terms of sensitivity and specificity for predicting endpoints in this population . Conclusion HbA1c levels were associated with a higher prevalence of CKD and CVD cross-sectionally , regardless of diabetes status . These data support the value of HbA1c as a marker of cardiovascular and renal disease in the general population BACKGROUND national policy is focused on early identification , referral and management of chronic kidney disease ( CKD ) to prevent both progression to endstage renal failure and cardiovascular disease . However , the significance of identifying CKD in older people is unclear . OBJECTIVE to determine the frequency of CKD in older people using estimated glomerular filtration rate ( eGFR ) , and its associations with morbidity and functional measures . DESIGN observational cross-sectional analysis of baseline data from a large cluster r and omised trial of health and social assessment of older people in the community . \n Output:\n " }, { "from": "agent", "value": "Conclusions The findings from this systematic review showed considerable variation in methods for sampling the general population and assessment of kidney function across studies reporting CKD prevalence .\nThese results are utilized to provide recommendations to help optimize both the design and the reporting of future CKD prevalence studies , which will enhance comparability of study results" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background : No r and omised studies have addressed whether self-management for asthma can be successfully delivered by community pharmacists . Most r and omised trials of asthma self-management have recruited participants from secondary care ; there is uncertainty regarding its effectiveness in primary care . A r and omised controlled study was undertaken to determine whether a community pharmacist could improve asthma control using self-management advice for individuals recruited during attendance at a community pharmacy . Methods : Twenty four adults attending a community pharmacy in Tower Hamlets , east London for routine asthma medication were r and omised into two groups : the intervention group received self-management advice from the pharmacist with weekly telephone follow up for 3 months and the control group received no input from the pharmacist . Participants self-completed the North of Engl and asthma symptom scale at baseline and 3 months later . Results : The groups were well matched at baseline for demographic characteristics and mean ( SD ) symptom scores ( 26.3 ( 4.8 ) and 27.8 ( 3.7 ) in the intervention and control groups , respectively ) . Symptom scores improved in the intervention group and marginally worsened in the control group to 20.3 ( 4.2 ) and 28.1 ( 3.5 ) , respectively ( p<0.001 ; difference adjusted for baseline scores = 7.0 ( 95 % CI 4.4 to 9.5 ) . Conclusions : A self-management programme delivered by a community pharmacist can improve asthma control in individuals recruited at a community pharmacy . Further studies should attempt to confirm these findings using larger sample s and a wider range of outcome measures Background Asthma is a prevalent and costly disease result ing in reduced quality of life for a large proportion of individuals . Effective patient self-management is critical for improving health outcomes . However , key aspects of self-management such as self-monitoring of behaviours and symptoms , coupled with regular feedback from the health care team , are rarely addressed or integrated into ongoing care . Health information technology ( HIT ) provides unique opportunities to facilitate this by providing a means for two way communication and exchange of information between the patient and care team , and access to their health information , presented in personalized ways that can alert them when there is a need for action . The objective of this study is to evaluate the acceptability and efficacy of using a web-based self-management system , My Asthma Portal ( MAP ) , linked to a case-management system on asthma control , and asthma health-related quality of life . Methods The trial is a parallel multi-centered 2-arm pilot r and omized controlled trial . Participants are r and omly assigned to one of two conditions : a ) MAP and usual care ; or b ) usual care alone . Individuals will be included if they are between 18 and 70 , have a confirmed asthma diagnosis , and their asthma is classified as not well controlled by their physician . Asthma control will be evaluated by calculating the amount of fast acting beta agonists recorded as dispensed in the provincial drug data base , and asthma quality of life using the Mini Asthma Related Quality of Life Question naire . Power calculations indicated a needed total sample size of 80 subjects . Data are collected at baseline , 3 , 6 , and 9 months post r and omization . Recruitment started in March 2010 and the inclusion of patients in the trial in June 2010 . Discussion Self-management support from the care team is critical for improving chronic disease outcomes . Given the high volume of patients and time constraints during clinical visits , primary care physicians have limited time to teach and reinforce use of proven self-management strategies . HIT has the potential to provide clinicians and a large number of patients with tools to support health behaviour change . Trial Registration Current Controlled Trials IS RCT N34326236 BACKGROUND Whether asthma morbidity in minority groups can be reduced by preventative health care measures delivered in the relevant ethnic dialects requires further evaluation . This study reports clinical outcomes and quality of life from a community based project investigating white European ( W/E ) and Indian subcontinent ( ISC ) ethnic groups with asthma living in deprived inner city areas of Birmingham , UK . METHODS Six hundred and eighty nine asthmatic subjects ( 345 W/E , 344 ISC ) of mean ( SD ) age 34.5 ( 15 ) years ( range 11–59 ) and mean forced expiratory volume in one second ( FEV1 ) of 80 % predicted were interviewed in English , Punjabi , Hindi , or Urdu . Subjects r and omised to the active limb of a prospect i ve , open , r and omised , controlled , parallel group , 12 month follow up study underwent individually based asthma education and optimisation of drug therapy with four monthly follow up ( active intervention ) . Control groups were seen only at the beginning and end of the study . Urgent or emergency interactions with primary and secondary health care ( clinical outcomes ) and both cross sectional and longitudinal data from an Asthma Quality of Life Question naire ( AQLQ ) were analysed . RESULTS Clinical outcomes were available for 593 subjects . Fewer of the active intervention group consulted their GP ( 41.8 % versus 57.8 % , odds ratio ( OR ) 0.52 ( 95 % CI 0.37 to 0.74 ) ) or were prescribed antibiotics ( 34.9 % versus 51.2 % , OR 0.51 ( 95 % CI 0.36 to 0.72 ) ) , but by ethnicity statistically significant changes occurred only in the W/E group with fewer also attending A&E departments and requiring urgent home visits . Active intervention reduced the number of hospital admissions ( 10 versus 30 ) , GP consultations ( 341 versus 476 ) , prescriptions of rescue oral steroids ( 92 versus 177 ) , and antibiotics ( 220 versus 340 ) , but again significant improvements by ethnicity only occurred in the active W/E group . AQLQ scores were negatively skewed to the higher values ; regression analysis showed that lower values were associated with ISC ethnicity . Longitudinal changes ( for 522 subjects ) in the mean AQLQ scores were small but statistically significant for both ethnic groups , with scores improving in the active and worsening in the control groups . CONCLUSIONS Active intervention only improved clinical outcomes in the W/E group . AQLQ scores , although lower in the ISC group , were improved by active intervention in both ethnic groups OBJECTIVE To report the results of a 2-year pilot program of asthma education based on National Heart , Lung , and Blood Institute treatment guidelines . PATIENTS AND METHODS Asthmatic members ( n = 6698 ) of a managed care organization received education about their condition directly or through their primary care physician . Medical and pharmacy administrative cl aims data were review ed to measure acute asthma events and prescribed therapies in the first ( the baseline ) and second years of the study . The cl aims data were augmented by member surveys from a stratified r and om sample of 2734 asthmatic patients who were members ( 6 years of age or older ) in the baseline year . RESULTS Compared with the first year , asthmatic members received fewer inpatient services and the proportion of asthmatic members prescribed oral inhaled corticosteroids increased 30 % in the second year . Health-related quality of life , measured with vali date d general and disease-specific instruments ; satisfaction with the quality of care ; exposure to patient education ; knowledge of the disease ; and member 's confidence in their ability to manage their disease showed statistically significant improvements during the follow-up year of the program for both adult and child asthmatic members . CONCLUSION For asthmatic members of this health plan , a comprehensive asthma health management program improved processes of care and outcomes Background Many studies have shown the effectiveness of self-management for patients with asthma . In particular , possession and use of a written asthma action plan provided by a doctor has shown to significantly improve patients ’ asthma control . Yet , uptake of a written asthma action plan and preventative asthma management is low in the community , especially amongst adults . Objective A Web-based personally controlled health management system ( PCHMS ) called Healthy.me will be evaluated in a 2010 CONSORT-compliant 2-group ( static websites verse PCHMS ) parallel r and omized controlled trial ( RCT ) ( allocation ratio 1:1 ) . Methods The PCHMS integrates an untethered personal health record with consumer care pathways and social forums . After eligibility assessment , a sample of 300 adult patients with moderate persistent asthma will be r and omly assigned to one of these arms . After 12 months of using either Healthy.me or information websites ( usual care arm ) , a post- study assessment will be conducted . Results The primary outcome measure is possession of or revision of an asthma action plan during the study . Secondary outcome measures include : ( 1 ) adherence to the asthma action plan , ( 2 ) rate of planned and unplanned visits to healthcare providers for asthma issues , ( 3 ) usage patterns of Healthy.me and attrition rates , ( 4 ) asthma control and asthma exacerbation scores , and ( 5 ) impact of asthma on life and competing dem and s , and days lost from work . Conclusions This RCT will provide insights into whether access to an online PCHMS will improve uptake of a written asthma action plan and preventative asthma actions . Trial Registration Trial Registration : Australian New Zeal and Clinical Trials Registry ACTRN12612000716864 ; https://www.anzctr.org.au/Trial/ Registration /Trial Review .aspx?id=362714 ( Archived by WebCite at http://www.webcitation.org/6IYBJGRnW ) Abstract Objectives : To evaluate the effectiveness of an asthma re source centre in improving treatment and quality of life for asthmatic patients Design : Community based r and omised controlled trial Setting : 41 general practice s in Greenwich with a practice nurse Subjects : All registered patients aged 15 - 50 years Intervention : Nurse specialists in asthma who educated and supported practice nurses , who in turn educated patients in the management of asthma according to the British Thoracic Society 's guidelines Main outcome measures : Quality of life of asthmatic patients , attendance at accident and emergency departments , admissions to local hospitals , and steroid prescribing by general practitioners Results : Of 24 400 patients r and omly selected and surveyed in 1993 , 12 238 replied ; 1621 were asthmatic of whom 1291 were sent a repeat question naire in 1996 and 780 replied . Of 24 400 patients newly surveyed in 1996 , 10 783 ( 1616 asthmatic ) replied . No evidence was found for an improvement in asthma related quality of life among newly surveyed patients in intervention practice s compared with control practice s. Neither was there evidence of an improvement in other measures of the quality of asthma care . Weak evidence was found for an improvement in quality of life in intervention practice s among asthmatics registered with study practice s in 1993 and followed up in 1996 . Neither attendances at accident and emergency departments nor admissions for asthma showed any tendency to diverge in intervention and control practice s over the study period . Steroid prescribing rates rose steadily during the study period . The average annual increase in steroid prescribing was 3 % per year higher in intervention than control practice s ( 95 % confidence interval −1 % to 6 % , P=0.10 ) Conclusions : This model of service delivery is not effective in improving the outcome of asthma in the community . Further development is required if cost effective management of asthma is to be A prospect i ve controlled trial of home monitoring of peak expiratory flow rate ( PEFR ) was conducted to determine the usefulness of an objective measure of lung function in association with an education program and a medication self-management plan in reducing morbidity in adult patients with asthma . Thirty-five patients managed themselves , using peak flow readings as the basis for the therapeutic plan coupled with educational intervention , whereas 35 control patients used symptoms and spirometric data for following physicians ' treatment plans . After a 6-mo study period , patients in the experimental group showed statistically significant improvements in morbidity parameters ( days lost from work , acute asthma attacks , days on antibiotic therapy , physician consultations , and emergency room admissions for asthma ) , increases in FVC , FEV1 , and FEV1/FVC , mean PEFR and mean morning PEFR , decrease in percentage of the mean PEFR amplitude , and a reduction in the use of inhaled beta-agonists , oral theophylline , and oral prednisone . Although improvements in some of these parameters were also found in the control group , they did not reach the levels of significance obtained in the experimental group . The personal use of an objective measure of lung function in association with a medication self-management plan leads to improvement in the patient 's condition OBJECTIVES Despite advances in recent years , asthma morbidity and mortality have been noted to be on the increase in the past decade . The present study examined the failures and recommendations of past studies and introduced a new milieu for asthma care -- the community pharmacy . The study incorporated a care protocol with the important ingredients of asthma education on medications , triggers , self-monitoring and an asthma plan , with pharmacists taking responsibility for outcomes , assessment of a patient 's readiness to change and tailoring education to that readiness , compliance monitoring and physician consultation to achieve asthma prescribing guidelines . METHODS Thirty-three pharmacists in British Columbia , specially trained and certified in asthma care , agreed to participate in a study in which experienced pharmacists would have asthma patients allocated to enhanced ( pharmaceutical ) care ( EC ) or usual care ( UC ) . Pharmacists less experienced were clustered by geography and had their pharmacies r and omized \n Output:\n " }, { "from": "agent", "value": "There is moderate to low quality evidence that chronic disease management programmes for adults with asthma can improve asthma-specific quality of life , asthma severity , and lung function tests .\nOverall , these results provide encouraging evidence of the potential effectiveness of these programmes in adults with asthma when compared with usual care ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: This article reports the severity and profile of neuropsychological impairment on a prevalent cohort of patients with a clinical diagnosis of either multiple system atrophy ( n=372 ) or progressive supranuclear palsy ( n=311 ) from the Neuroprotection and Natural History in Parkinson Plus Syndromes cohort . The Dementia Rating Scale and Frontal Assessment Battery were used to assess global cognition and executive dysfunction . For the Dementia Rating Scale impairment was observed in approximately 57 % of the progressive supranuclear palsy group and 20 % of the multiple system atrophy group . In the former , impairment in a single cognitive domain was observed in 40 % , with the same number showing impairment in multiple domains , while in the latter the figures were 28.6 and 13.5 % , respectively . On the Frontal Assessment Battery , impairment was observed in 62.0 % of patients with progressive supranuclear palsy and 31.8 % of those with multiple system atrophy . Although the progressive supranuclear palsy group performed worse overall , the cognitive profiles of the two groups on the Dementia Rating Scale subscales were identical , with the main impairment of the Initiation and Perseveration subscale . The impaired patients in the two groups were largely indistinguishable , qualitatively and quantitatively . Impairment was associated with greater age and clinical disability in both groups and was evident even in the early stages ( 22 % in multiple system atrophy and 50 % in progressive supranuclear palsy ) . Where a pathological diagnosis was available , the original clinical diagnosis was confirmed in the majority of cases , including those with significant cognitive impairment . The rate of impairment in those with a confirmed pathological diagnosis was comparable to that of the sample as a whole . These results demonstrate , in the largest prospect ively recruited cohort of patients with progressive supranuclear palsy and multiple system atrophy studied to date , the existence of a cognitive profile similar to that previously reported in idiopathic Parkinson 's disease . The results indicate a high level of cognitive impairment associated with progressive supranuclear palsy , but also point to comparable dysfunction in a substantial proportion of the patients with multiple system atrophy . Significant cognitive impairment appears consistent with a diagnosis of multiple system atrophy , even early in the disease , with important implication s for diagnosis , research and management Abstract Bilateral deep brain stimulation is an effective treatment for most motor signs of Parkinson 's disease ( PD ) , but the effects on cognitive functions are less clear . We therefore examined the effects of bilateral deep brain stimulation on central information processing , using the event-related auditory P300 potential as an electrophysiological index of mental chronometry . Eight PD patients with bilateral stimulators within the subthalamic nuclei ( STN ) and eight age-matched controls participated . Patients were examined after overnight withdrawal of antiparkinson medication , both “ on ” and “ off ” stimulation ( in r and om sequence ) . The P300 and reaction times were recorded using an auditory oddball paradigm . P300 latencies were prolonged in PD patients off stimulation ( 440 ± 45 ms ) compared to controls ( 397 ± 16 ms ; P < 0.05 ) . STN stimulation significantly reduced clinical disease severity ( as indexed by the Unified Parkinson 's Disease Rating Scale ) and markedly improved reaction times , but did not improve the prolonged P300 latencies in PD patients ( 429 ± 36 ms ) . These results confirm that P300 latencies are prolonged in PD . Significantly , bilateral STN stimulation did not improve this electrophysiological measure of cognitive impairment , even though motor disability was markedly reduced . This suggests that some dopa-responsive features are resistant to STN stimulation , possibly due to involvement of dopaminergic deficits outside the nigrostriatal pathway , which are not influenced by outflow from the STN In this study , individuals with Parkinson ’s disease were tested as a model for basal ganglia dysfunction to infer how these structures contribute to the processing of emotional speech tone ( emotional prosody ) . Nondemented individuals with and without Parkinson ’s disease ( n = 21/group ) completed neuropsychological tests and tasks that required them to process the meaning of emotional prosody in various ways ( discrimination , identification , emotional feature rating ) . Individuals with basal ganglia disease exhibited abnormally reduced sensitivity to the emotional significance of prosody in a range of context s , a deficit that could not be attributed to changes in mood , emotional-symbolic processing , or estimated frontal lobe cognitive re source limitations in most conditions . On the basis of these and broader findings in the literature , it is argued that the basal ganglia provide a critical mechanism for reinforcing the behavioral significance of prosodic patterns and other temporal representations derived from cue sequences ( Lieberman , 2000 ) , facilitating cortical elaboration of these events We previously reported that the P1 or P50 midlatency evoked potential underwent decreased habituation or disinhibition in patients with Parkinson 's Disease . This sleep state-dependent response appears to be generated by cholinergic elements of the reticular activating system . We attempted to determine if the decreased habituation or disinhibition of the P1 potential would be altered by bilateral pallidotomy . Twenty-three patients who met inclusion criteria for surgery underwent pre- and post-operative evaluation using a Modified United Parkinson 's Disease Rating Scale ( UPDRS ) and P1 potential recordings . Decreased habituation of the P1 potential was determined using a paired stimulus paradigm in which click stimuli were presented at 250 , 500 and 1000 msec interstimulus intervals ( ISI ) . Pre-operatively , patients showed disinhibition of the P1 potential at the 250 msec ISI ( 60 37 % vs. 21 20 % ) and 500 msec ISI ( 78 47 % vs. 43 31 % ) compared to age-matched control subjects . Post-operatively , the same patients showed a significant improvement in habituation of the P1 potential at the same ISIs ( 250 msec 37 21 % ; 500 msec 43 32 % ) . UPDRS scores for these patients pre-operatively were 59 18 and 24 11 post-operatively , result ing in a significant reduction in symptom severity . We conclude that bilateral pallidotomy result ed in a significant improvement in symptom ratings and reduced the disinhibition of the P1 midlatency evoked response To assess cortical and subcortical contributions to phonemic processing , patients with left frontal , temporal-parietal , or cerebellar lesions as well as those with Parkinson 's disease were tested on phonemic identification and production tasks . In Experiment 1 , patients and controls were asked to identify syllables on both a voicing and place of articulation continuum . Subcortical patients were relatively unimpaired at this task whereas cortical patients were less accurate at identifying the endpoints of both continua and exhibited little evidence of categorical perception . For Experiment 2 , controls and patients were asked to produce syllables . Subcortical patients were able to produce contrastive voice onset times ( VOTs ) for voicing cognates although VOT of the voiceless phoneme was more variable for cerebellar patients . Cortical patients showed greater overlap in the production of both VOT and formant transition intervals . These results are discussed in terms of the type of computations hypothesized to originate from each neural area Auditory event-related potentials were recorded using the oddball paradigm in 26 patients with Parkinson 's disease , all treated with L-Dopa . The latency of the P3 wave was significantly greater than in an age-matched controls , and was also correlated with the disease duration , but not with scores on two scales measuring cognitive deficit . One year later , when treatment with a dopaminergic agonist , bromocriptine 20 - 30 mg/day , had been added to the therapeutic regimen , N2 and P3 latencies had increased , whereas several clinical parameters had improved . Thus a longer P3 latency does not seem to be linked to a global cognitive deficit . The use of neuropsychological tests exploring more limited tasks should show the prospect i ve utility of event-related potentials in Parkinson 's disease Auditory event related potentials ( ERPs ) and visual evoked potentials ( VEPs ) were recorded from eight patients with Parkinson 's disease , before and after a single dose of apomorphine . To assess the treatment effects , the patients ' motor state , Benton visual retention test ( BVRT ) , and digit span tests were also examined . After apomorphine , although motor performance improved , the ERP latencies were delayed and the N2-P3 ERP amplitude was significantly diminished by comparison with pretreatment values . These data suggest that apomorphine induces , besides its motor effects in patients with Parkinson 's disease , a slowing down of cognitive processing . Preferential stimulation of dopamine autoreceptors in mesocortical and mesolimbic systems may represent a neural mechanism for these effects . Also , the posttreatment BVRT rotation errors significantly increased , suggesting an apomorphine induced impairment of visuospatial perception Abstract . Rationale : Cholecystokinin ( CCK ) is a neuropeptide which is colocalized with dopamine ( DA ) in neurons of the mesolimbic-frontocortical and nigrostriatal DA system . In animals CCK enhances DA activity in these systems . Objectives : The present study examined the effects of a single intranasal administration of CCK-8 on auditory brain potential ( AEP ) signs of cognitive processing and on motor performance in patients with Parkinson 's disease ( PD ) , known to originate from degeneration of DA neurons primarily in the nigrostriatal DA system . Methods : Thirteen PD patients were examined after medication withdrawal , on two occasions after administration of placebo and 25 µg CCK-8 , and compared with healthy controls matched for age and sex . AEPs were recorded while subjects performed an attention task ( oddball paradigm ) . Results : In the placebo condition , AEPs in the PD patients did not show marked alteration but were rather comparable to those in the controls . In healthy controls , CCK-8 enhanced the P3 complex ( P<0.05 ) and shortened latencies of the N2 and P3 components of the AEP evoked by task relevant target stimuli ( P<0.05 ) . Contrary to expectations , in PD patients these AEP components were distinctly delayed after CCK–8 ( P<0.05 ) . Motor performance was not changed by CCK-8 in PD patients or in controls . Conclusion : Data indicate a deleterious rather than beneficial effect of CCK on cognitive processing in PD patients that might result from a prevailing effect of the neuropeptide on transmitter systems ( e.g. GABAergic ) other than the DA system Nondemented Parkinson ’s disease ( PD ) patients showed increased amplitude of event-related potential component P3 . We recorded 18-channel spontaneous eyes-closed resting EEG and auditory oddball event-related potentials in 29 PD patients and 11 age-matched controls . Combining Mini-Mental State Examination score and oddball P3 counting performance , 15 patients were intellectually normal , 7 moderately , and 7 severely demented . P3 and N1 amplitude and latency , mean amplitude of 1,024 ms post-stimulus ( separate after rare and after frequent stimuli ) , and resting EEG total power for 40 s were computed , and linearly regressed for age , sex , and L-dopa dosage . In nondemented PD patients , increased P3 amplitude was confirmed , but N1 amplitude and mean amplitude after rare and frequent stimuli were also increased as well as – most important – resting EEG total power . With increasing dementia , amplitude and power decreased , and P3 latency increased . Task dem and s can not explain increased P3 amplitude , since similarly increased EEG total power was found during no-task resting . Prospect i ve studies must determine whether P3 amplitude and EEG power in nondemented PD patients can serve as predictors of dementia Recent evidence suggests that the frontal lobe plays an important role in an orienting response to novel events , and that frontal lobe dysfunction is linked to attentional and cognitive deficits in Parkinson 's disease ( PD ) . We tested the hypothesis that the neural network involved in novelty detection may be impaired in PD patients by study ing event-related brain potentials to target and novel stimuli and their correlation to performance in neuropsychological tests in non-demented PD patients . The PD patients showed prolonged P3 latency to novel stimuli compared with age-matched controls , whereas their P3 latency to target stimuli was not different from that in controls . The PD patients also manifested amplitude reduction and less habituation of the P3 to novel stimuli over frontal scalp sites compared with controls . The prolonged latency and frontal reduction of novelty P3 correlated with a poor performance in the Wisconsin Card Sorting Test . These results suggest that the orienting response of PD patients to novel events is impaired and that recording novelty P3 might provide a neurophysiological and quantitative measure of attentional and cognitive deficits linked to the frontal lobe in non-demented PD patients In the present study , we compared the performance of normal subjects in three age groups and of medicated Parkinson 's disease patients on auditory selective attention processes . Two tone sequences were dichotically presented . Subjects responded to deviant tones in the attended location . Event-related potentials ( ERPs ) were recorded from nine scalp electrodes . The old group showed significant decline in hit rate , increase in N1 amplitude , and reduction in P3a , P3b , target negativity , and mismatch negativity amplitude . The amplitude and duration of late Nd increased with age , reflecting modulation of both attended and unattended st and ard ERPs \n Output:\n " }, { "from": "agent", "value": "The collected data revealed distinct impairments in a range of central auditory processes in PD , including altered deviance detection of basic auditory features , auditory brainstem processing , auditory gating and selective auditory attention .\nIn contrast to PD , literature on central auditory processing in MSA and PSP was relatively scarce , but provided some evidence for impaired central auditory processing in MSA and PSP ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Ultrafiltration is an alternative strategy to diuretic therapy for the treatment of patients with acute decompensated heart failure . Little is known about the efficacy and safety of ultrafiltration in patients with acute decompensated heart failure complicated by persistent congestion and worsened renal function . METHODS We r and omly assigned a total of 188 patients with acute decompensated heart failure , worsened renal function , and persistent congestion to a strategy of stepped pharmacologic therapy ( 94 patients ) or ultrafiltration ( 94 patients ) . The primary end point was the bivariate change from baseline in the serum creatinine level and body weight , as assessed 96 hours after r and om assignment . Patients were followed for 60 days . RESULTS Ultrafiltration was inferior to pharmacologic therapy with respect to the bivariate end point of the change in the serum creatinine level and body weight 96 hours after enrollment ( P=0.003 ) , owing primarily to an increase in the creatinine level in the ultrafiltration group . At 96 hours , the mean change in the creatinine level was -0.04±0.53 mg per deciliter ( -3.5±46.9 μmol per liter ) in the pharmacologic-therapy group , as compared with + 0.23±0.70 mg per deciliter ( 20.3±61.9 μmol per liter ) in the ultrafiltration group ( P=0.003 ) . There was no significant difference in weight loss 96 hours after enrollment between patients in the pharmacologic-therapy group and those in the ultrafiltration group ( a loss of 5.5±5.1 kg [ 12.1±11.3 lb ] and 5.7±3.9 kg [ 12.6±8.5 lb ] , respectively ; P=0.58 ) . A higher percentage of patients in the ultrafiltration group than in the pharmacologic-therapy group had a serious adverse event ( 72 % vs. 57 % , P=0.03 ) . CONCLUSIONS In a r and omized trial involving patients hospitalized for acute decompensated heart failure , worsened renal function , and persistent congestion , the use of a stepped pharmacologic-therapy algorithm was superior to a strategy of ultrafiltration for the preservation of renal function at 96 hours , with a similar amount of weight loss with the two approaches . Ultrafiltration was associated with a higher rate of adverse events . ( Funded by the National Heart , Lung , and Blood Institute ; Clinical Trials.gov number , NCT00608491 . ) UNLABELLED Slow continuous ultrafiltration ( SCUF ) , continuous veno venous haemofiltration ( CVVHF ) are alternative to diuretics methods of treatment of patients with chronic heart failure ( CHF ) , edematous syndrome . METHODS Patients of both sexes aged 30 - 82 years with functional class II-IV CHF were included because of decompensation of CHF . R and omization : experiment - 19 patients , 3 - 4 component therapy plus SCUF or CVVHF ; control - 3 - 4 component therapy plus intravenous furosemide . EXAMINATION I ñ at baseline , II ñ after compensation of CHF . RESULTS Delta weight ( kg ) - experiment -10.1+/-1.08 , control -1.92+/-0.83 , p=0.00001 ; Delta left ventricular ejection fraction - experiment + 10.09+/-2.26 , control + 0.52+/-1.14 , p=0.0007 ; pulmonary artery systolic pressure ( mm Hg ) - experiment -12.32+/-3,43 , control -4.05 + /-2.07 , p=0.029 ; Delta 6 min walk test : experiment + 304.22+/-39.4 , control + 91.91+/-23.4 , p=0.00003 ; Delta glomerular filtration rate - experiment -1.16+/-3.23 , control + 4.44+/-3.68 , p=0.85 ; duration of hospitalization ( days ) - experiment 17.26+/-1.43 , control 17.52+/-1.02 , p=0.59 . We did not observe complications related to renal replacement therapy . CONCLUSION SCUF and CVVHF are safe for patients . In decompensated CHF SCUF and CVVHF provide greater weight reduction and fluid removal than intravenous diuretics , abolish hypervolemia what cause improvement of myocardial contractility OBJECTIVES The AVOID-HF ( Aquapheresis versus Intravenous Diuretics and Hospitalization for Heart Failure ) trial tested the hypothesis that patients hospitalized for HF treated with adjustable ultrafiltration ( AUF ) would have a longer time to first HF event within 90 days after hospital discharge than those receiving adjustable intravenous loop diuretics ( ALD ) . BACKGROUND Congestion in hospitalized heart failure ( HF ) patients portends unfavorable outcomes . METHODS The AVOID-HF trial , design ed as a multicenter , 1-to-1 r and omized study of 810 hospitalized HF patients , was terminated unilaterally and prematurely by the sponsor ( Baxter Healthcare , Deerfield , Illinois ) after enrollment of 224 patients ( 27.5 % ) . Aquadex FlexFlow System ( Baxter Healthcare ) was used for AUF . A Clinical Events Committee , blinded to the r and omized treatment , adjudicated whether 90-day events were due to HF . RESULTS A total of 110 patients were r and omized to AUF and 114 to ALD . Baseline characteristics were similar . Estimated days to first HF event for the AUF and ALD group were , respectively , 62 and 34 ( p = 0.106 ) . At 30 days , compared with the ALD group , the AUF group had fewer HF and cardiovascular events . Renal function changes were similar . More AUF patients experienced an adverse effect of special interest ( p = 0.018 ) and a serious study product-related adverse event ( p = 0.026 ) . The 90-day mortality was similar . CONCLUSIONS Compared with the ALD group , the AUF group trended toward a longer time to first HF event within 90 days and fewer HF and cardiovascular events . More patients in the AUF group experienced special interest or serious product-related adverse event . Due to the trial 's untimely termination , additional AUF investigation is warranted Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Background and Objectives In the Ultrafiltration versus Intravenous Diuretics for Patients Hospitalized for Acute Decompensated Heart Failure trial , ultrafiltration ( UF ) removed volume more effectively than usual care ( UC ) . Hypothetically , UF may be superior to UC due to increased sodium ( Na ) removal and less neurohormonal activation . We compared UF and UC in a r and omized pilot trial of target weight guided therapy for acute decompensated heart failure ( ADHF ) . Subjects and Methods Sixteen patients with ADHF were enrolled and target weights established prospect ively , prior to r and omization to UC or UF . UF patients did not receive diuretics and UC patients were all treated with a continuous furosemide drip . All urine and ultrafiltrate were collected and Na concentrations measured . Results Similar volumes were removed in UC and UF groups ( 110105 mL and 107415 mL , respectively ) and the UF group also produced 45325 mL of urine . Na concentration was 138±6 meq/L in the ultrafiltrate , 85±73 meq/L in the UC group 's urine , and 26±23 meq/L in the UF group 's urine . Given the relevant associated volumes , total meq of the Na removed was similar ( 1168 in UC vs. 1216 in UF ) . The UF group produced isotonic ultrafiltrate and a higher volume of dilute urine than anticipated . Conclusion In a r and omized pilot study of target weight guided therapy with UC or UF for ADHF , there were no differences in total volumes or Na removed , and lengths of hospital stays were similar . Isotonic fluid loss by UF was accompanied by the production of very dilute urine OBJECTIVES The purpose of this research was to assess the safety and efficacy of ultrafiltration ( UF ) in patients admitted with decompensated congestive heart failure ( CHF ) . BACKGROUND Ultrafiltration for CHF is usually reserved for patients with renal failure or those unresponsive to pharmacologic management . We performed a r and omized trial of UF versus usual medical care using a simple UF device that does not require special monitoring or central intravenous access . METHODS Patients admitted for CHF with evidence of volume overload were r and omized to a single , 8 h UF session in addition to usual care or usual care alone . The primary end point was weight loss 24 h after the time of enrollment . RESULTS Forty patients were enrolled ( 20 UF , 20 usual care ) . Ultrafiltration was successful in 18 of the 20 patients in the UF group . Fluid removal after 24 h was 4,650 ml and 2,838 ml in the UF and usual care groups , respectively ( p = 0.001 ) . Weight loss after 24 h , the primary end point , was 2.5 kg and 1.86 kg in the UF and usual care groups , respectively ( p = 0.240 ) . Patients tolerated UF well . CONCLUSIONS The early application of UF for patients with CHF was feasible , well-tolerated , and result ed in significant weight loss and fluid removal . A larger trial is underway to determine the relative efficacy of UF versus st and ard care in acute decompensated heart failure Background : There are limited data comparing ultrafiltration with st and ard medical therapy as first-line treatment in patients with severe congestive heart failure ( HF ) . We compared ultrafiltration and conventional therapy in patients hospitalized for HF and overt fluid overload . Methods and Results : Fifty-six patients with congestive HF were r and omized to receive st and ard medical therapy ( control group ; n = 29 ) or ultrafiltration ( ultrafiltration group ; = 27 ) . The primary endpoint of the study was rehospitalizations for congestive HF during a 1-year follow-up . Despite similar body weight reduction at hospital discharge in the 2 groups ( 7.5 ± 4.5 and 7.9 ± 5.0 kg , respectively;P = .75 ) , a lower incidence of rehospitalizations for HF was observed in the ultrafiltration-treated patients during the following year ( hazard ratio 0.14 , 95 % confidence interval 0.04 - 0.48 ; P = .002).Ultrafiltration-induced benefit was associated with a more stable renal function , unchanged furosemide dose , and lower B-type natriuretic peptide levels . At 1 year , 7 deaths ( 30 % ) occurred in the ultrafiltration group and 11 ( 44 % ) in the control group ( P = .33 ) . Conclusions : In HF patients with severe fluid overload , first-line treatment with ultrafiltration is associated with a prolonged clinical stabilization and a greater freedom from rehospitalization for congestive HF Compared with conventional diuretic ( CD ) therapy , ultrafiltration ( UF ) is associated with greater weight loss and fewer re-hospitalizations in patients admitted with decompensated heart failure ( HF ) . Concerns have been raised regarding its safety and efficacy in patients with more advanced heart failure . The authors conducted a single-center , prospect i ve , r and omized controlled trial in patients with advanced HF admitted to an intensive care unit for hemodynamically guided therapy , comparing UF ( n=17 ) with CD ( n=19 ) at admission . The primary end point was the time required for pulmonary capillary wedge pressure ( PCWP ) to be maintained at a value of ≤18 mm Hg for at least 4 consecutive hours . Secondary end points included levels of cytokines and neurohormones , as well as several clinical outcomes . In our study cohort , the time to achieve the primary end point was lower in the UF group but did not reach statistical significance ( P = .08 ) . UF result ed in greater weight reduction , higher total volume removed , and shorter hospital length of stay . There were no differences in kidney function , biomarkers , or adverse events . In patients with advanced HF under hemodynamically tailored therapy , UF can be safely performed to achieve higher average volume removed than CD therapy without leading to adverse outcomes CONTEXT Vasopressin mediates fluid retention in heart failure . Tolvaptan , a vasopressin V2 receptor blocker , shows promise for management of heart failure . OBJECTIVE To investigate the effects of tolvaptan initiated in patients hospitalized with heart failure . DESIGN , SETTING , AND PARTICIPANTS The Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study With Tolvaptan ( EVEREST ) , an event-driven , r and omized , double-blind , \n Output:\n " }, { "from": "agent", "value": "Ultrafiltration showed significantly higher fluid removal and weight loss .\nUltrafiltration showed reduced 90 days heart failure readmissions and trend towards reduced cumulative hospital readmissions ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: CONTEXT Of the 200 million adults worldwide who undergo noncardiac surgery each year , more than 1 million will die within 30 days . OBJECTIVE To determine the relationship between the peak fourth-generation troponin T ( TnT ) measurement in the first 3 days after noncardiac surgery and 30-day mortality . DESIGN , SETTING , AND PARTICIPANTS A prospect i ve , international cohort study that enrolled patients from August 6 , 2007 , to January 11 , 2011 . Eligible patients were aged 45 years and older and required at least an overnight hospital admission after having noncardiac surgery . MAIN OUTCOME MEASURES Patients ' TnT levels were measured 6 to 12 hours after surgery and on days 1 , 2 , and 3 after surgery . We undertook Cox regression analysis in which the dependent variable was mortality until 30 days after surgery , and the independent variables included 24 preoperative variables . We repeated this analysis , adding the peak TnT measurement during the first 3 postoperative days as an independent variable and used a minimum P value approach to determine if there were TnT thresholds that independently altered patients ' risk of death . RESULTS A total of 15,133 patients were included in this study . The 30-day mortality rate was 1.9 % ( 95 % CI , 1.7%-2.1 % ) . Multivariable analysis demonstrated that peak TnT values of at least 0.02 ng/mL , occurring in 11.6 % of patients , were associated with higher 30-day mortality compared with the reference group ( peak TnT ≤ 0.01 ng/mL ) : peak TnT of 0.02 ng/mL ( adjusted hazard ratio [ aHR ] , 2.41 ; 95 % CI , 1.33 - 3.77 ) ; 0.03 to 0.29 ng/mL ( aHR , 5.00 ; 95 % CI , 3.72 - 6.76 ) ; and 0.30 ng/mL or greater ( aHR , 10.48 ; 95 % CI , 6.25 - 16.62 ) . Patients with a peak TnT value of 0.01 ng/mL or less , 0.02 , 0.03 - 0.29 , and 0.30 or greater had 30-day mortality rates of 1.0 % , 4.0 % , 9.3 % , and 16.9 % , respectively . Peak TnT measurement added incremental prognostic value to discriminate those likely to die within 30 days for the model with peak TnT measurement vs without ( C index = 0.85 vs 0.81 ; difference , 0.4 ; 95 % CI , 0.2 - 0.5 ; P < .001 for difference between C index values ) . The net reclassification improvement with TnT was 25.0 % ( P < .001 ) . CONCLUSION Among patients undergoing noncardiac surgery , the peak postoperative TnT measurement during the first 3 days after surgery was significantly associated with 30-day mortality Background — To identify patients at risk for postoperative myocardial injury and death , measuring cardiac troponin routinely after noncardiac surgery has been suggested . Such monitoring was implemented in our hospital . The aim of this study was to determine the predictive value of postoperative myocardial injury , as measured by troponin elevation , on 30-day mortality after noncardiac surgery . Methods and Results — This observational , single-center cohort study included 2232 consecutive intermediate- to high-risk noncardiac surgery patients aged ≥60 years who underwent surgery in 2011 . Troponin was measured on the first 3 postoperative days . Log binomial regression analysis was used to estimate the association between postoperative myocardial injury ( troponin I level > 0.06 & mgr;g/L ) and all-cause 30-day mortality . Myocardial injury was found in 315 of 1627 patients in whom troponin I was measured ( 19 % ) . All-cause death occurred in 56 patients ( 3 % ) . The relative risk of a minor increase in troponin ( 0.07–0.59 & mgr;g/L ) was 2.4 ( 95 % confidence interval , 1.3–4.2 ; P<0.01 ) , and the relative risk of a 10- to 100-fold increase in troponin ( ≥0.60 & mgr;g/L ) was 4.2 ( 95 % confidence interval , 2.1–8.6 ; P<0.01 ) . A myocardial infa rct ion according to the universal definition was diagnosed in 10 patients ( 0.6 % ) , of whom 1 ( 0.06 % ) had ST-segment elevation myocardial infa rct ion . Conclusions — Postoperative myocardial injury is an independent predictor of 30-day mortality after noncardiac surgery . Implementation of postoperative troponin monitoring as st and ard of care is feasible and may be helpful in improving the prognosis of patients undergoing noncardiac surgery BACKGROUND Dual-antiplatelet therapy with aspirin and a thienopyridine is a cornerstone of treatment to prevent thrombotic complications of acute coronary syndromes and percutaneous coronary intervention . METHODS To compare prasugrel , a new thienopyridine , with clopidogrel , we r and omly assigned 13,608 patients with moderate-to-high-risk acute coronary syndromes with scheduled percutaneous coronary intervention to receive prasugrel ( a 60-mg loading dose and a 10-mg daily maintenance dose ) or clopidogrel ( a 300-mg loading dose and a 75-mg daily maintenance dose ) , for 6 to 15 months . The primary efficacy end point was death from cardiovascular causes , nonfatal myocardial infa rct ion , or nonfatal stroke . The key safety end point was major bleeding . RESULTS The primary efficacy end point occurred in 12.1 % of patients receiving clopidogrel and 9.9 % of patients receiving prasugrel ( hazard ratio for prasugrel vs. clopidogrel , 0.81 ; 95 % confidence interval [ CI ] , 0.73 to 0.90 ; P<0.001 ) . We also found significant reductions in the prasugrel group in the rates of myocardial infa rct ion ( 9.7 % for clopidogrel vs. 7.4 % for prasugrel ; P<0.001 ) , urgent target-vessel revascularization ( 3.7 % vs. 2.5 % ; P<0.001 ) , and stent thrombosis ( 2.4 % vs. 1.1 % ; P<0.001 ) . Major bleeding was observed in 2.4 % of patients receiving prasugrel and in 1.8 % of patients receiving clopidogrel ( hazard ratio , 1.32 ; 95 % CI , 1.03 to 1.68 ; P=0.03 ) . Also greater in the prasugrel group was the rate of life-threatening bleeding ( 1.4 % vs. 0.9 % ; P=0.01 ) , including nonfatal bleeding ( 1.1 % vs. 0.9 % ; hazard ratio , 1.25 ; P=0.23 ) and fatal bleeding ( 0.4 % vs. 0.1 % ; P=0.002 ) . CONCLUSIONS In patients with acute coronary syndromes with scheduled percutaneous coronary intervention , prasugrel therapy was associated with significantly reduced rates of ischemic events , including stent thrombosis , but with an increased risk of major bleeding , including fatal bleeding . Overall mortality did not differ significantly between treatment groups . ( Clinical Trials.gov number , NCT00097591 [ Clinical Trials.gov ] . OBJECTIVE The aim of this trial was to evaluate the bleeding after dental extraction s among patients on uninterrupted antiplatelet therapy . MATERIAL S AND METHODS A total of 190 patients under oral antiplatelet drugs requiring extraction of a single molar tooth were r and omly assigned to two groups . Group A consisted of 95 patients on uninterrupted antiplatelet therapy and Group B consisted of 95 patients who have discontinued antiplatelet medication 5 days prior to extraction . The bleeding time of all patients was checked prior to extraction . The surgical procedure involved simple extraction of a single molar tooth under local anesthesia . The extraction socket was sutured with 3 - 0 silk . Pressure pack with gauze was given for 1 h. Bleeding after 1 h , 24 h , 48 h , and 5 days were compared between two groups . Chi-square test was used to compare the variables . P < 0.05 was taken as significant . RESULTS None of the patients in either group had any significant uncontrollable bleeding after extraction . CONCLUSION Hence , we recommend routine single tooth extraction s in patients on long-term antiplatelet medication , without interruption or alteration of their medication . Such patients do not have an increased risk of prolonged or excessive postoperative bleeding BACKGROUND Variation in and irreversibility of platelet inhibition with clopidogrel has led to controversy about its optimum dose and timing of administration in patients with acute coronary syndromes . We compared ticagrelor , a more potent reversible P2Y12 inhibitor with clopidogrel in such patients . METHODS At r and omisation , an invasive strategy was planned for 13 408 ( 72.0 % ) of 18 624 patients hospitalised for acute coronary syndromes ( with or without ST elevation ) . In a double-blind , double-dummy study , patients were r and omly assigned in a one-to-one ratio to ticagrelor and placebo ( 180 mg loading dose followed by 90 mg twice a day ) , or to clopidogrel and placebo ( 300 - 600 mg loading dose or continuation with maintenance dose followed by 75 mg per day ) for 6 - 12 months . All patients were given aspirin . The primary composite endpoint was cardiovascular death , myocardial infa rct ion , or stroke . Analyses were by intention to treat . This trial is registered with Clinical Trials.gov , number NCT00391872 . FINDINGS 6732 patients were assigned to ticagrelor and 6676 to clopidogrel . The primary composite endpoint occurred in fewer patients in the ticagrelor group than in the clopidogrel group ( 569 [ event rate at 360 days 9.0 % ] vs 668 [ 10.7 % ] , hazard ratio 0.84 , 95 % CI 0.75 - 0.94 ; p=0.0025 ) . There was no difference between clopidogrel and ticagrelor groups in the rates of total major bleeding ( 691 [ 11.6 % ] vs 689 [ 11.5 % ] , 0.99 [ 0.89 - 1.10 ] ; p=0.8803 ) or severe bleeding , as defined according to the Global Use of Strategies To Open occluded coronary arteries , ( 198 [ 3.2 % ] vs 185 [ 2.9 % ] , 0.91 [ 0.74 - 1.12 ] ; p=0.3785 ) . INTERPRETATION Ticagrelor seems to be a better option than clopidogrel for patients with acute coronary syndromes for whom an early invasive strategy is planned BACKGROUND There is substantial variability in the perioperative administration of aspirin in patients undergoing noncardiac surgery , both among patients who are already on an aspirin regimen and among those who are not . METHODS Using a 2-by-2 factorial trial design , we r and omly assigned 10,010 patients who were preparing to undergo noncardiac surgery and were at risk for vascular complications to receive aspirin or placebo and clonidine or placebo . The results of the aspirin trial are reported here . The patients were stratified according to whether they had not been taking aspirin before the study ( initiation stratum , with 5628 patients ) or they were already on an aspirin regimen ( continuation stratum , with 4382 patients ) . Patients started taking aspirin ( at a dose of 200 mg ) or placebo just before surgery and continued it daily ( at a dose of 100 mg ) for 30 days in the initiation stratum and for 7 days in the continuation stratum , after which patients resumed their regular aspirin regimen . The primary outcome was a composite of death or nonfatal myocardial infa rct ion at 30 days . RESULTS The primary outcome occurred in 351 of 4998 patients ( 7.0 % ) in the aspirin group and in 355 of 5012 patients ( 7.1 % ) in the placebo group ( hazard ratio in the aspirin group , 0.99 ; 95 % confidence interval [ CI ] , 0.86 to 1.15 ; P=0.92 ) . Major bleeding was more common in the aspirin group than in the placebo group ( 230 patients [ 4.6 % ] vs. 188 patients [ 3.8 % ] ; hazard ratio \n Output:\n " }, { "from": "agent", "value": "Conclusion It was concluded that the clinical trials were classified as good quality and that it was not necessary to suspend antiplatelet therapy prior to surgical procedures such as dental extraction and transurethral resection of bladder cancer ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: A prospect i ve study was undertaken to compare the accuracy of the Lachman test , anterior drawer test and jerk test with the KT1000 knee arthrometer in patients with proven anterior cruciate ligament deficiency . The Lachman and anterior drawer tests were found to be the most accurate indicators of anterior cruciate ligament deficiency . The KT1000 knee arthrometer was found to be totally inaccurate , which precludes its use as an objective measure of anteroposterior laxity of the knee The Losee repair controls rotational subluxation of the lateral femoral condyle , or pivot shift , but does not reliably eliminate Lachman laxity . Despite this surgical limitation , many patients who were operated on continued to do high-dem and activities at the last followup . We hypothesized that Lachman findings alone did not predict poor surgical outcome or progression to osteoarthritis . We report on 87 patients evaluated at an average of 9 years ( range , 5 - 21 years ) postoperatively . Prospect ively collected examinations and radiographic , subjective , and objective outcome measures were recorded and statistically evaluated . The presence of a postoperative pivot shift or residual varus laxity correlated with poor patient subjective evaluations and poor scoring outcomes . Lachman laxity with an absent pivot shift had no correlation with the outcome measures or onset of radiographic progression to osteoarthritis . Meniscectomy , additional knee surgery , increased valgus or varus laxity , and time from injury until the final radiograph positively correlated with the onset of osteoarthritis . Elimination of the pivot shift was necessary to achieve successful relief of symptoms and functional outcome . In the absence of a pivot shift , Lachman laxity was not solely predictive of poor outcomes . Level of Evidence : Prognostic study , Level II-1 ( retrospective study ) . See the Guidelines for Authors for a complete description of levels of evidence We conducted a prospect i ve r and omised study of anatomical single-bundle ( A-SB group ) versus double-bundle ( A-DB group ) anterior cruciate ligament ( ACL ) reconstruction using the hamstrings tendons . Twenty patients with unilateral ACL deficiency were r and omised into two groups . We created the bone tunnels at the position of the original insertion of the anteromedial bundle footprint and posterolateral bundle footprint in the A-DB group and at the central position between these two bundles in the A-SB group . All of the patients were tested before ACL reconstruction and one year after surgery . The KT-1000 measurements , isokinetic muscle peak torque and heel-height difference were evaluated and the general knee condition was assessed by Lysholm score . For pre- and postoperative stability assessment , we used the six-degrees-of-freedom of knee kinematic measurement system using an electromagnetic device ( the EMS ) for quantitative assessment during the Lachman test and the pivot shift test . There were no significant differences in the KT-1000 measurements , isokinetic muscle peak torque , heel-height difference , and Lysholm score at one-year follow-up between these two groups . The EMS data showed there were significant differences in the acceleration of the pivot shift test between the operated knee and the contralateral normal knees in the A-SB group . In conclusion , clinical outcomes were equally good in both groups . However , the EMS data showed the anatomical double-bundle ACL reconstruction tended to be biomechanically superior to the single-bundle reconstruction Purpose Combinations of intra- and extra-articular procedures have been proposed for anterior cruciate ligament reconstruction with the aim of achieving an optimal control of translational and rotational knee laxities . Recently , the need for better reproducing the structural and functional behavior of the native anterior cruciate ligament led to the definition of anatomic double-bundle surgical approach . This study aim ed to quantitatively verify whether the in vivo static and dynamic behavior obtained using over-the-top single-bundle with extra-articular tenodesis reconstruction was comparable to the results achieved by anatomic double-bundle approach . Methods Thirty-five consecutive patients , with an isolated anterior cruciate ligament injury , were included in the study . St and ard clinical laxities and pivot-shift test were quantified before and after anterior cruciate ligament reconstruction by means of a surgical navigation system dedicated to kinematic assessment ; displacements of medial and lateral compartment during stress tests were also analyzed . Results Single-bundle with extra-articular tenodesis approach presented statistically better laxity reduction in varus/valgus stress test at full extension and in internal/external rotation at 90 ° of flexion ; lateral plasty controlled better the lateral compartment during drawer test and varus/valgus stress test both at 0 ° and 30 ° of flexion and both the compartments during internal/external rotation at 90 ° of flexion . On the other h and , pivot-shift phenomenon was better controlled by anatomic double-bundle reconstruction . Conclusions Both the reconstructions worked similarly for static knee laxity . The extra-articular procedure played an important role in better constraining the displacement of lateral tibial compartment , whereas the anatomic double-bundle reconstruction better restored the dynamic behavior of knee joint highlighted under pivot-shift stress test . Study design Case series Abstract Although magnetic resonance imaging ( MRI ) has improved the diagnostic accuracy of meniscal pathology , the authors believe that physical examination remains essential to the evaluation of knee pathology . In this study , the diagnostic accuracy of five clinical tests for meniscal pathology was prospect ively evaluated in 160 patients , who thereafter underwent arthroscopy . 69 % ( 109 knees ) of the knees tested had associated ACL deficiency . There were 144 meniscal lesions in 130 of the 160 knees which were examined . The sensitivity of the tests was lower than the specificity . Conventional tests such as McMurray and Apley tests showed a low accuracy rate of 45 % and 28 % respectively . The diagnostic value of the axially loaded pivot shift test was significantly higher , indicating that this remains a useful diagnostic aid . Résumé Ils évaluent prospect ivement la précision diagnostique de cinq différentes épreuves cliniques employées pour confirmer des déchirures méniscales chez des 160 sujets ayant subi une évaluation arthroscopique . Soixante – neuf pour cent ( 109 ) des genoux contrôlés par les auteurs présentaient une carence arthrocinétique complexe . Ils ont observé 144 déchirures méniscales sur 130 genoux . Toutes les épreuves cliniques présentaient généralement une sensibilité inférieure à leur spécificité . Quant au test de déplacement du pivot sous charge axiale , le fait que sa valeur diagnostique est , dans l’ensemble , significativement supérieure à celle des autres manoeuvres diagnostiques en fait un supplément de choix dans l’arsenal diagnostique Double-bundle anterior cruciate ligament ( ACL ) reconstruction reproduces anteromedial and posterolateral bundles , and thus has theoretical advantages over conventional single-bundle reconstruction in controlling rotational torque in vitro . However , its superiority in clinical practice has not been proven . We analyzed rotational stability with three reconstruction techniques in 60 consecutive patients who were r and omly divided into three groups ( double-bundle , anteromedial single-bundle , posterolateral single-bundle ) . In the reconstructive procedure , the hamstring tendon was harvested and used as a free tendon graft . Followup examinations were performed 1 year after surgery . Anteroposterior laxity of the knee was examined with a KT-1000 arthrometer , whereas rotatory instability , as elicited by the pivot shift test , was assessed using a new measurement system incorporating three-dimensional electromagnetic sensors . Routine clinical evaluations , including KT examination , demonstrated no differences among the three groups . However , using the new measurement system , patients with double-bundle ACL reconstruction showed better pivot shift control of complex instability than patients with anteromedial and posterolateral single-bundle reconstruction . Level of Evidence : Level II , therapeutic study . See the Guideline for Authors for a complete description of levels of evidence Clinical evaluation of knee instability is often difficult to reproduce , and several different physical tests have become popular . In an attempt to eluci date reasons for variations in the degree of pivot shift phenomenon seen with the use of the various tests , we have prospect ively evaluated a group of 37 patients with surgically docu mented ACL injuries , noting the effects of hip position and tibial rotation . The patients were examined under anesthesia , and the pivot shift was grade d as 0 ( absent , or negative ) , 0.5 + ( trace ) , 1 + , 2 + , or 3 + ( with locking ) . All knees were tested in hip abduction , neutral , and hip adduction , and with the tibia in external and internal rotation , so that six positions were evaluated . Hip position strongly correlated with the degree of pivot shift regardless of tibial rotation . Overall , abduc tion produced the greatest degree of pivot shift , fol lowed by neutral and finally adduction . External tibial rotation increased the pivot shift score in abduction and neutral , but not in adduction . A grading system for the subject population showed that abduction/external ro tation ( ABDER ) result ed in the highest pivot shift scores , and that adduction/external rotation ( ADDER ) and adduction/internal rotation ( ADDIR ) result ed in the lowest scores . Nine patients out of 20 with a 3 + pivot shift in ABDER were negative in ADDER . The pivot shift score was dampened at least one grade from ABDER to ADDER in 92 % of the patients . We conclude that hip position and tibial rotation affect the degree of pivot shift phenomenon , and it is our impression that the iliotibial b and plays a significant role in controlling the degree of pivot shift observed . When examining a knee for ACL insufficiency , it is critical to pay attention to the position of the leg because varia tions in hip position and tibial rotation affect the gra dation of the pivot shift sign and a false negative test may be elicited CLINICAL QUESTION In patients presenting with possible rupture of the anterior cruciate ligament ( ACL ) , which diagnostic test can provide an accurate diagnosis during the physical examination ? DATA SOURCES Two review ers search ed MEDLINE ( 1966 to February 14 , 2003 ) and EMBASE ( 1980 to February 14 , 2003 ) . Articles written in English , French , German , or Dutch were included . The key search terms were knee injuries , knee joint , and knee . These terms were combined with the headings joint instability and anterior cruciate ligament , as well as the text words laxity , instability , cruciate , and effusion . The results of these search es were combined with the subject headings sensitivity and specificity , physical examination , and not ( animal not [ human and animal ] ) . Additional text words search ed were sensitivit * , specificit * , false positive , false negative , accuracy , screening , physical examination , and clinical examination . The reference lists of included articles were examined . STUDY SELECTION Inclusion criteria consisted of ( 1 ) investigation of at least one physical diagnostic test for assessment of ACL ruptures in the knee and ( 2 ) the use of a reference st and ard of arthrotomy , arthroscopy , or magnetic resonance imaging . DATA EXTRACTION Two independent review ers extracted data from each included study . The method ologic quality of each test was assessed and recorded on a checklist for the screening of diagnostic tests ( www.cochrane.de/cochrane/sadtdoc1.htm ) . The 3 diagnostic tests vali date d in this review were the pivot shift test , the anterior drawer test , and the Lachman test . A summary receiver operating characteristic curve was performed for each test , and the sensitivity , specificity , and predictive values were reported . MAIN RESULTS The search strategy produced 1090 potentially eligible studies , of which 17 studies were selected . One study was included via reference list examination and 2 reports referred to the same study . Thus , 17 studies met the inclusion criteria and were used for this review . For the included studies , the sample size ranged from 32 to 300 patients . As for the age of the subjects , the authors of 4 studies failed to report it . Thus , the average age of patients across 13 of the 17 studies was 28.6 years . Authors of all studies failed to measure the clinical test and reference st and ard separately and with blinding . In addition , all but two studies had a significant degree of verification bias . Arthrotomy was the lone reference st and ard in 4 studies whereas arthrotomy/arthroscopy was the reference st and ard in 5 studies . Arthroscopy alone was the reference st and ard in 6 studies where only 2 studies used MRI as the reference st and ard . Authors of 8 studies examined the anterior drawer test and reported sensitivity values ranging from 0.18 - 0.92 and specificity values ranging from 0.78 - 0.98 . When pooled together using the bivariate r and om effects model ( BREM ) , the sensitivity value of the 8 studies was 0.2 and the specificity value was 0.88 . Authors of 9 studies examined the Lachman test and reported sensitivity values ranging from 0.63 - 0.93 and specificity values ranging from 0.55 - 0.99 . Pooled together using the BREM , the sensitivity value was 0.86 and the specificity value was 0.91 . Lastly , authors of 6 studies examined the pivot shift test and reported sensitivity values ranging from 0.18 - 0.48 and specificity values ranging from 0.97 - 0.99 . Data for the pivot shift test could not be pooled using the BREM because of the low number of available studies . Predictive values were reported graphically , with the pivot shift test having the highest positive predictive value and the Lachman test having the best negative predictive value . CONCLUSIONS Based on predictive value statistics \n Output:\n " }, { "from": "agent", "value": "The pivot shift test has been quantified by means of 25 parameters , but most of the studies focused on anterior-posterior translations , internal – external rotation and acceleration in anterior-posterior direction ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVES To evaluate the cost-effectiveness of a 9-month preventive occupational therapy ( OT ) program in the Well-Elderly Study : a r and omized trial in independent-living older adults that found significant health , function , and quality of life benefits attributable to preventive OT . DESIGN A r and omized trial . SETTING Two government-subsidized apartment complexes . PARTICIPANTS One hundred sixty-three culturally diverse volunteers aged 60 and older . INTERVENTION An OT group , a social activity group ( active control ) , and a nontreatment group ( passive control ) . MEASUREMENTS Use of healthcare services was determined by telephone interview during and after the treatment phase . A conversion algorithm was applied to the R AND 36-item Short Form Health Survey to derive a preference-based health-related quality of life index , quality -adjusted life years ( QALYs ) , and the incremental cost-effectiveness ratio for preventive OT relative to the combined control group . RESULTS Costs for the 9-month OT program averaged $ 548 per subject . Postintervention healthcare costs were lower for the OT group ( $ 967 ) than for the active control group ( $ 1,726 ) , the passive control group ( $ 3,334 ) , or a combination of the control groups ( $ 2,593 ) . The quality of life index showed a 4.5 % QALY differential ( OT vs combined control ) , P < .001 . The cost per QALY estimates for the OT group was $ 10,666 ( 95 % confidence interval = $ 6,747-$25,430 ) . For the passive and active control groups , the corresponding costs per QALY were $ 13,784 and $ 7,820 , respectively . CONCLUSION In this study , preventive OT demonstrated cost-effectiveness in conjunction with a trend toward decreased medical expenditures Background : multifactorial falls prevention programmes for older people have been proved to reduce falls . However , evidence of their cost-effectiveness is mixed . Design : economic evaluation alongside pragmatic r and omised controlled trial . Intervention : r and omised trial of 364 people aged ≥70 , living in the community , recruited via GP and identified as high risk of falling . Both arms received a falls prevention information leaflet . The intervention arm were also offered a ( day hospital ) multidisciplinary falls prevention programme , including physiotherapy , occupational therapy , nurse , medical review and referral to other specialists . Measurements : self-reported falls , as collected in 12 monthly diaries . Levels of health re source use associated with the falls prevention programme , screening ( both attributed to intervention arm only ) and other health-care contacts were monitored . Mean NHS costs and falls per person per year were estimated for both arms , along with the incremental cost-effectiveness ratio ( ICER ) and cost effectiveness acceptability curve . Results : in the base-case analysis , the mean falls programme cost was £ 349 per person . This , coupled with higher screening and other health-care costs , result ed in a mean incremental cost of £ 578 for the intervention arm . The mean falls rate was lower in the intervention arm ( 2.07 per person/year ) , compared with the control arm ( 2.24 ) . The estimated ICER was £ 3,320 per fall averted . Conclusions : the estimated ICER was £ 3,320 per fall averted . Future research should focus on adherence to the intervention and an assessment of impact on quality of life OBJECTIVES Falls and fall injuries are common-potentially preventable-causes of morbidity , functional decline , and increased health-care use among elderly persons . The current analyses , performed on data obtained as part of a r and omized controlled trial conducted within a health maintenance organization , describe the costs of a multifactorial , targeted prevention program for falls , present total net health-care costs , estimate the cost per fall prevented , and describe acute fall-related health-care costs . METHODS The 301 participants were at least 70 years of age and possessed at least one of eight targeted risk factors for falling . The 153 participants r and omized to the targeted intervention ( TI ) group received a combination of medication adjustment , behavioral recommendations , and exercises as determined by their baseline assessment . The 148 participants r and omized to the usual care ( UC ) group received a series of home visits by a social work student . RESULTS The mean intervention cost per TI participant was $ 925 ( range $ 588 to $ 1,346 ) . Total mean health-care costs were approximately $ 2,000 less in the TI than UC group , whereas median costs were approximately $ 1,100 higher in the TI than UC group . The TI strategy was unequivocally cost effective when mean costs were used because the intervention was associated with both lowered total health-care costs and fewer total and medical care falls . In sensitivity analyses , the cost-effectiveness of the TI strategy appeared robust to widely differing assumptions about total health-care costs ( 25th to 75th percentile of the actual distribution ) and intervention costs ( minimum to maximum costs ) . In subgroup analyses , the TI strategy showed its strongest effect among individuals at high risk of falling , defined as possession of at least four of the eight targeted risk factors . CONCLUSIONS Consideration should be given toward incorporating and reimbursing the cost of fall-prevention programs within the usual health care of community-living elderly persons , particularly for those persons at high risk for falling OBJECTIVE To determine the effectiveness of community based occupational therapy on daily functioning of patients with dementia and the sense of competence of their care givers . DESIGN Single blind r and omised controlled trial . Assessors were blinded for treatment allocation . SETTING Memory clinic and day clinic of a geriatrics department and participants ' homes . PARTICIPANTS 135 patients aged > or = 65 with mild to moderate dementia living in the community and their primary care givers . INTERVENTIONS 10 sessions of occupational therapy over five weeks , including cognitive and behavioural interventions , to train patients in the use of aids to compensate for cognitive decline and care givers in coping behaviours and supervision . MAIN OUTCOME MEASURES Patients ' daily functioning assessed with the assessment of motor and process skills ( AMPS ) and the performance scale of the interview of deterioration in daily activities in dementia ( IDDD ) . Care giver burden assessed with the sense of competence question naire ( SCQ ) . Participants were evaluated at baseline , six weeks , and three months . RESULTS Scores improved significantly relative to baseline in patients and care givers in the intervention group compared with the controls ( differences were 1.5 ( 95 % confidence interval 1.3 to 1.7 ) for the process scale ; -11.7 ( -13.6 to -9.7 ) for the performance scale ; and ( 11.0 ; 9.2 to 12.8 ) for the competence scale ) . This improvement was still significant at three months . The number needed to treat to reach a clinical ly relevant improvement in motor and process skills score was 1.3 ( 1.2 to 1.4 ) at six weeks . Effect sizes were 2.5 , 2.3 , and 1.2 , respectively , at six weeks and 2.7 , 2.4 , and 0.8 , respectively , at 12 weeks . CONCLUSIONS Occupational therapy improved patients ' daily functioning and reduced the burden on the care giver , despite the patients ' limited learning ability . Effects were still present at 12 weeks , which justifies implementation of this intervention . TRIAL REGISTRATION Clinical Trials NCT00295152 [ Clinical Trials.gov ] Objective To assess the cost effectiveness of community based occupational therapy compared with usual care in older patients with dementia and their care givers from a societal viewpoint . Design Cost effectiveness study alongside a single blind r and omised controlled trial . Setting Memory clinic , day clinic of a geriatrics department , and participants ’ homes . Patients 135 patients aged ≥65 with mild to moderate dementia living in the community and their primary care givers . Intervention 10 sessions of occupational therapy over five weeks , including cognitive and behavioural interventions , to train patients in the use of aids to compensate for cognitive decline and care givers in coping behaviours and supervision . Main outcome measures Incremental cost effectiveness ratio expressed as the difference in mean total care costs per successful treatment ( that is , a combined patient and care giver outcome measure of clinical ly relevant improvement on process , performance , and competence scales ) at three months after r and omisation . Bootstrap methods used to determine confidence intervals for these measures . Results The intervention cost € 1183 ( £ 848 , $ 1738 ) ( 95 % confidence interval € 1128 ( £ 808 , $ 1657 ) to € 1239 ( £ 888 , $ 1820 ) ) per patient and primary care giver unit at three months . Visits to general practitioners and hospital doctors cost the same in both groups but total mean costs were € 1748 ( £ 1279 , $ 2621 ) lower in the intervention group , with the main cost savings in informal care . There was a significant difference in proportions of successful treatments of 36 % at three months . The number needed to treat for successful treatment at three months was 2.8 ( 2.7 to 2.9 ) . Conclusions Community occupational therapy intervention for patients with dementia and their care givers is successful and cost effective , especially in terms of informal care giving Background Major depressive disorder is among the medical conditions with the highest negative impact on work outcome . However , little is known regarding evidence -based interventions targeting the improvement of work outcomes in depressed employees . In this paper , the design of a r and omized controlled trial is presented in order to evaluate the effectiveness of adjuvant occupational therapy in employees with depression . This occupational intervention is based on an earlier intervention , which was design ed and proven effective by our research group , and is the only intervention to date that specifically targets work outcome in depressed employees . Methods / Design In a two-arm r and omized controlled trial , a total of 117 participants are r and omized to either ' care as usual ' or ' care as usual ' with the addition of occupational therapy . Patients included in the study are employees who are absent from work due to depression for at least 25 % of their contract hours , and who have a possibility of returning to their own or a new job . The occupational intervention consists of six individual sessions , eight group sessions and a work-place visit over a 16-week period . By increasing exposure to the working environment , and by stimulating communication between employer and employee , the occupational intervention aims to enhance self-efficacy and the acquisition of more adaptive coping strategies . Assessment s take place at baseline , and at 6 , 12 , and 18-month follow-ups . Primary outcome measure is work participation ( hours of absenteeism and time until work resumption ) . Secondary outcome measures are work functioning , symptomatology , health-related quality of life , and neurocognitive functioning . In addition , cost-effectiveness is evaluated from a societal perspective . Finally , mechanisms of change ( intermediate outcomes ) and potential patient-treatment matching variables are investigated . Discussion This study hopes to provide valuable knowledge regarding an intervention to treat depression , one of the most common and debilitating diseases of our time . If our intervention is proven ( cost- ) effective , the personal , economic , and health benefits for both patients and employers are far-reaching . Trial registration The effectiveness and cost of day hospital care in rehabilitation were studied in a r and omised controlled trial in 120 elderly patients who were assessed at referral and six weeks and five months later in activities of daily living skills and mood . Day hospital patients were compared with a control group , who were managed as they would have been before the availability of day hospital care . Day hospital patients showed a significant improvement in performance of activities of daily living at six weeks but not at five months ; however , they had a sustained improvement in mood . The cost of day hospital rehabilitation was one third greater than that of rehabilitation by alternative means . In its current form the geriatric day hospital is not a cheap alternative to other means of rehabilitation . Expensive components of the day hospital should be critically re-examined and renewed emphasis placed on sufficient inpatient beds , domiciliary services , and day care centres Background Annually , about 30 % of the persons of 65 years and older falls at least once and 15 % falls at least twice . Falls often result in serious injuries , such as fractures . Therefore , the prevention of accidental falls is necessary . The aim is to describe the design of a study that evaluates the efficacy and cost-effectiveness of a multidisciplinary assessment and treatment of multiple fall risk factors in independently living older persons with a high risk of falling . Methods / Design The study is design ed as a r and omised controlled trial ( RCT ) with an economic evaluation . Independently living persons of 65 years and older who recently experienced a fall are interviewed in their homes and screened for risk of recurrent falling using a vali date d fall risk profile . Persons at low risk of recurrent falling are excluded from the RCT . Persons who have a high risk of recurrent falling are blindly r and omised into an intervention ( n = 100 ) or usual care ( n = 100 ) group . The intervention consists of a multidisciplinary assessment and treatment of multifactorial fall risk factors . The transmural multidisciplinary appraoch entails close cooperation between geriatrician , primary care physician , physical therapist and occupational therapist and can be extended with other specialists if relevant . A fall calendar is used to record falls during one year of follow-up . Primary outcomes are time to first and second falls . Three , six and twelve months after the home visit , question naires for economic evaluation are completed . After one year , during a second home visit , the secondary outcome measures are reassessed and the adherence to the interventions is evaluated . Data will be analysed according to the intention-to-treat principle and also an on-treatment analysis \n Output:\n " }, { "from": "agent", "value": "These studies found that occupational therapy for older people was clinical ly effective and cost-effective in comparison with st and ard care or other therapies .\nWith reference to their clinical implication , these intervention studies ( using a client-centred approach ) suggested potentially cost-effective means to motivate clients to maintain their own health ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity The aim of this study was to assess to what extent adult Herbst treatment is an alternative to orthognathic surgery by comparing the dentoskeletal treatment effects in 46 adult Class II Division 1 subjects treated with a combined orthodontic-orthognathic surgery approach ( m and ibular sagittal split osteotomy without genioplasty ) and 23 adult Class II Division 1 subjects treated with the Herbst appliance . Lateral headfilms in habitual occlusion from before and after treatment ( multibracket appliance treatment after surgery or Herbst treatment ) were analyzed . All surgery and Herbst subjects were treated successfully to Class I occlusal relationships with normal overjet and overbite . In the surgery group , the improvement in sagittal occlusion was achieved by skeletal more than dental changes ; in the Herbst group , the opposite was the case . Skeletal and soft tissue facial profile convexity was reduced significantly in both groups , but the amount of profile convexity reduction was larger in the surgery group . The success and predictability of Herbst treatment for occlusal correction was as high as for surgery . Thus , Herbst treatment can be considered an alternative to orthognathic surgery in borderline adult skeletal Class II malocclusions , especially when a great facial improvement is not the main treatment goal Aim : It was the aim of this clinical study to compare the skeletal and dentoalveolar effects as well as those on the profile of three different treatment approaches in Class II patients ( camouflage orthodontics , dentofacial orthopedics , and combined orthodontic and surgical treatment ) . Patients and Method : Our study cohort consisted of 60 young adults presenting a skeletal Class II , Division 1 malocclusion : 20 patients whose overjet was reduced by camouflage following premolar extraction , 20 patients whose occlusions were corrected by placement of a fixed functional orthopedic appliance , and 20 who underwent orthognathic surgery ( bilateral sagittal split osteotomy of the m and ible without genioplasty ) . We documented the therapeutic progress using cephalometry . Results : Each patient group achieved a reduction in overjet via their respective treatment . While no treatment-related changes in the maxillary area were assessable , the effects on the m and ible differed . We observed advancement of the bony chin and an increase in m and ibular length in the sagittal-diagonal dimension in the surgical and functional orthopedic groups . However , the extent of the treatment-related changes was significant only in the group of patients that had undergone orthognathic surgery . Only the surgical group presented changes in vertical relationships . Incisor repositioning as an outcome of the respective treatments differed fundamentally , with those in the surgical group revealing significant protrusion of the upper incisors . The maxillary incisors were retruded and m and ibular incisors proclined in the functional orthopedic group , whereas the upper and lower incisors both retruded significantly in the extraction group . Softtissue remodeling bore no linear relationship to treatment-induced skeletal and dental effects . Still , orthognathic surgery led to the most marked profile changes . Treatment using fixed functional orthopedic appliances reduced the convexity of the soft-tissue profile at least moderately . Camouflage orthodontics , on the other h and , result ed in an increase in the nasolabial angle . Conclusions : In young adults fixed functional appliances are a treatment alternative to extraction therapy but to a lesser extent to orthognathic surgery . Because of their limited skeletal effects and minor changes in the profile they are indicated only in patients with a moderately severe Class II malocclusion . Pre-treatment proclined m and ibular incisors limit the scope of indications for fixed functional appliances , as they can cause an increase in lower incisor proclination . Significant reductions in profile convexity are achievable only by combined orthodontic and surgical treatment of the malocclusion . When performing camouflage orthodontics in conjunction with maxillary premolar extraction s in adults , an increase in the nasolabial angle , which is often esthetically undesirable , has to be discussed as a potential side effect and has to be taken into account when considering the different therapeutic approaches . ZusammenfassungZiel : Ziel einer klinischen Studie war es , skelettale und dentoalveoläre Effekte sowie Auswirkungen auf das Profil bei drei unterschiedlichen Beh and lungen von Distalbisslagen ( Camouflage-Orthodontie , dentofaziale Orthopädie , Kombinationsbeh and lung Orthodontie und Dysgnathiechirurgie ) zu vergleichen . Patienten und Method e : Das Prob and engut umfasste 60 junge Adulte mit einer skelettalen Klasse-II/1-Anomalie : 20 Patienten , bei denen nach Prämolarenextraktionen durch Camouflage-Orthodontie die sagittale Frontzahnstufe verringert wurde , 20 Patienten , bei denen ein festsitzendes funktionskieferorthopädisches Gerät zur Korrektur der Bisslagen eingegliedert wurde , sowie 20 Dysgnathiechirurgiefälle ( bilaterale sagittale Spaltosteotomie der M and ibula ohne Genioplastik ) . Die Beh and lungsverläufe wurden kephalometrisch dokumentiert . Ergebnisse : Bei allen Patientengruppen konnte infolge der jeweiligen Beh and lung eine Reduktion der sagittalen Frontzahnstufe erreicht werden . Während keine therapiebedingten Veränderungen i m maxillären Bereich evaluiert werden konnten , differierten die Effekte auf die M and ibula : Vorverlagerungen des knöchernen Kinns und Längenzunahmen der M and ibula in sagittal-diagonaler Richtung waren bei den Patienten der Chirurgie- und der Funktionskieferorthopädie-(FKO-)Gruppe nachweisbar , jedoch war das Ausmaß der therapeutischen Veränderung nur in der Gruppe der dysgnathiechirurgisch beh and elten Patienten signifikant . Veränderungen der vertikalen Relation f and en lediglich in der Chirurgiegruppe statt . Die infolge der jeweiligen Beh and lung result ierenden Positionsveränderungen der Schneidezähne unterschieden sich grundlegend : Eine signifikante Protrusion der oberen Schneidezähne konnte bei den Patienten der Chirurgiegruppe festgestellt werden . In der FKO-Gruppe wurden die oberen Inzisivi retrahiert und die unteren Schneidezähne nach labial gekippt . In der Extraktionsgruppe hingegen wurden beide Schneidezahnpartien signifikant retrahiert . Die Weichgewebeadaptationen st and en in keinem linearen Zusammenhang zu den therapeutisch erzielten skelettalen und dentalen Effekten . Dennoch result ierten infolge der Dysgnathiechirurgie die ausgeprägtesten Veränderungen des Profils . Durch eine Beh and lung mit festsitzenden funktionskieferorthopädischen Geräten erfuhr auch das Weichteilprofil eine zumindest moderate Konvexitätsreduzierung . Eine Camouflage-Orthodontie hingegen führte insbesondere zu einer Vergrößerung des Nasolabialwinkels . Schlussfolgerungen : Aufgrund der nur eingeschränkten skelettalen Wirkungen und der geringen Auswirkungen auf das Profil sind festsitzende funktionskieferorthopädische Geräte bei jungen Adulten eine therapeutische Alternative zur Extraktionstherapie , weniger zur Dysgnathiechirurgie und nur bei Patienten mit einer moderat ausgeprägten Klasse-II-Anomalie indiziert . Eine bereits prätherapeutisch vorh and ene Protrusion der Unterkieferfront stellt aufgrund einer therapiebedingten Progredienz eine Indikationseinschränkung für festsitzende funktionskieferorthopädische Geräte dar . Eine signifikante Reduktion der Profilkonvexität kann nur infolge einer kombiniert orthodontisch-dysgnathiechirurgischen Beh and lung erzielt werden . Bei Durchführung einer Camouflage-Orthodontie mit Extraktion von Prämolaren des Oberkiefers muss bei Erwachsenen eine ästhetisch oft unerwünschte Vergrößerung des Nasolabialwinkels als mögliche Nebenwirkung diskutiert und bei differentialtherapeutischen Überlegungen beachtet werden INTRODUCTION Previous research has demonstrated that current methods of informed consent are relatively ineffective as shown by poor recall and comprehension by adolescent patients and their parents . The purpose of this study was to determine whether adding a short videotape presentation reiterating the issues related to informed consent to a modified informed consent document that emphasizes a limited number of core and patient-specific custom \" chunks \" at the beginning of an informed consent presentation improved the recall and comprehension of the risks , benefits , and alternatives of orthodontic treatment . A second objective was to evaluate the current related data for recommendable practice s. METHODS Seventy patient-parent pairs were r and omly divided into 2 groups . The intervention group ( group A ) patients and parents together review ed a customized slide show and a short videotape presentation describing the key risks of orthodontic treatment . Group B followed the same protocol without viewing the videotape . All patients and parents were interviewed independently by research assistants using an established measurement tool with open-ended questions . Interviews were transcribed and scored for the appropriateness of responses using a previously established codebook . Lastly , the patients and parents were given 2 reading literacy tests , 1 related to health and 1 with general content followed by the self-administered demographic and psychological state question naires . RESULTS There were no significant differences between the groups for sociodemographic variables . There were no significant differences between the groups for overall recall and comprehension ; recall and comprehension for the domains of treatment , risk , and responsibility ; and recall and comprehension for core , general , and custom items . The positional effects were limited in impact . When compared with previous studies , these data further demonstrate the benefit of improved readability and audiovisual supplementation with the addition of \" chunking . \" CONCLUSIONS There is no benefit to adding a short video to the previously established improved readability and audiovisual supplementation . There is a significant benefit of improved readability and audiovisual slide supplementation with the addition of \" chunking \" over traditional informed consent methods in terms of patient improvement in overall comprehension , treatment recall , and treatment comprehension . The treatment domain is the most affected OBJECTIVE To compare two groups of subjects at the peak of the pubertal growth period treated with the Functional M and ibular Advancer ( FMA ; Forestadent , Pforzheim , Germany ) appliance using either single-step or stepwise m and ibular advancement . MATERIAL S AND METHODS This study was conducted on 34 Class II division 1 malocclusion subjects at or just before the peak phase of pubertal growth as assessed by h and -wrist radiographs . Subjects were assigned to two groups of m and ibular advancement , using matched r and omization . Both groups were treated with the FMA . While the m and ible was advanced to a super Class I molar relation in the single-step advancement group ( SSG ) , patients in the stepwise m and ibular advancement group ( SWG ) had a 4-mm initial bite advancement and subsequent 2-mm advancements at bimonthly intervals . The material consisted of lateral cephalograms taken before treatment and after 10 months of FMA treatment . Data were analyzed by means paired t-tests and an independent t-test . RESULTS There were statistically significant changes in SNB , Pg horizontal , ANB , Co-Gn , and Co-Go measurements in both groups ( P < .001 ) ; these changes were greater in the SWG with the exception of Co-Go ( P < .05 ) . While significant differences were found in U1-SN , IMPA , L6 horizontal , overjet , and overbite appraisal s in each group ( P < .001 ) , these changes were comparable ( P > .05 \n Output:\n " }, { "from": "agent", "value": "The difference between treatments was not statistically significant regarding SNA angle , linear measurement of the lower lip to Ricketts ' aesthetic line , convexity of the skeletal profile , or the soft tissue profile excluding the nose .\nIn contrast , surgical-orthodontic treatment was more effective with regard to ANB , SNB , and ML/NSL angles and the soft tissue profile including the nose .\nDifferent treatment effects on overjet and overbite were found according to the severity of the initial values ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE To evaluate aripiprazole once-monthly ( AOM ) , a long-acting injectable suspension of aripiprazole , as acute treatment in patients with schizophrenia ( DSM-IV-TR ) . METHOD Adults experiencing an acute psychotic episode were r and omized to 12 weeks of double-blind treatment with AOM 400 mg or placebo ( October 2012-August 2013 ) . The primary efficacy outcome was change from baseline to endpoint ( week 10 ) in Positive and Negative Syndrome Scale ( PANSS ) total score . The key secondary efficacy outcome was change from baseline in Clinical Global Impressions-Severity of Illness scale ( CGI-S ) score . Secondary efficacy outcomes included change from baseline in PANSS positive and negative subscale and Personal and Social Performance Scale ( PSP ) scores . The study took place from October 2012 through August 2013 . RESULTS Patients ( N = 340 ; 79 % male , 66 % black ) were r and omized to AOM ( n = 168 ) or placebo ( n = 172 ) . Least squares ( LS ) mean change from baseline to endpoint ( week 10 ) favored AOM versus placebo in PANSS total ( treatment difference , -15.1 [ 95 % CI , -19.4 to -10.8 ] ; P < .0001 ) and CGI-S ( treatment difference , -0.8 [ 95 % CI , -1.1 to -0.6 ] ; P < .0001 ) scores , as it did at all other timepoints through 12 weeks ( all P ≤ .0005 ) . LS mean change from baseline in PANSS positive and negative subscale and PSP scores favored AOM versus placebo ( P < .0001 ) . Common ( > 10 % ) treatment-emergent adverse events ( AOM vs. placebo ) were increased weight ( 16.8 % vs 7.0 % ) , headache ( 14.4 % vs. 16.3 % ) , and akathisia ( 11.4 % vs 3.5 % ) . CONCLUSIONS Symptoms and functioning improved with AOM 400 mg versus placebo in patients with acute schizophrenia , with acceptable safety and tolerability . These data suggest that AOM 400 mg is a viable treatment option for patients experiencing an acute schizophrenia episode . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT01663532 BACKGROUND Persons with schizophrenia often come in contact with the criminal justice system ( CJS ) . This analysis of subjects with schizophrenia and a history of contact with the CJS estimated and compared mean cumulative function ( MCF ) of treatment failure events when treated with paliperidone palmitate ( PP ) or oral antipsychotics ( OAs ) . All events identified during the full study period of the Paliperidone Palmitate Research in Demonstrating Effectiveness ( PRIDE ) trial were evaluated . METHODS Subjects were r and omly assigned to flexibly dosed , monthly , injectable PP ( 78 - 234 mg ) or daily OA in a 15-month prospect i ve , open-label , multicenter US study ( May 5 , 2010-December 9 , 2013 ) . Subjects could continue participation after a treatment failure event . Multiple treatment failures in individual subjects were analyzed as recurrent events . Analyses estimated MCF of treatment failure events and MCF of institutionalizations ( arrests , incarcerations , or psychiatric hospitalizations ) during the 15-month study period . RESULTS The ITT population included 226 ( PP ) and 218 ( OA ) subjects , of whom 41.2 % and 40.4 % , respectively , completed 15 months of follow-up . The MCF of treatment failures and institutionalizations differed significantly in favor of PP compared with OA ( P=0.007 and P=0.005 , respectively ) . Overall , TEAEs were reported by 86.3 % of subjects in the PP group and 81.7 % in the OA group . CONCLUSIONS This pragmatic analysis suggests that , compared with OA , PP is not only more effective in delaying median time to treatment failure , but it also reduces the number of treatment failures and institutionalizations per person-year follow-up . CLINICAL TRIALS REGISTRATION Clinical trials.gov identifier : NCT01157351 Abstract Background QUALIFY was a 28-week , r and omized , open-label , head-to-head trial that assessed improvements across multiple measures in stable patients with schizophrenia with aripiprazole once-monthly 400 mg vs paliperidone palmitate . Methods Secondary effectiveness assessment s included physician-rated readiness for work using the Work Readiness Question naire , the Clinical Global Impression – Severity and Clinical Global Impression – Improvement scales , and quality of life with the rater-blinded Heinrichs-Carpenter Quality of Life Scale . Patients assessed their treatment satisfaction and quality of life with Subjective Well-Being under Neuroleptic Treatment−short version and Tolerability and Quality of Life question naires . Results Odds of being ready for work at week 28 were significantly higher with aripiprazole once-monthly 400 mg vs paliperidone palmitate ( adjusted odds ratio , 2.67 ; 95 % CI , 1.39−5.14 ; P=.003 ) . Aripiprazole once-monthly 400 mg produced numerically or significantly greater improvements from baseline vs paliperidone palmitate in all Quality of Life Scale items . With aripiprazole once-monthly 400 mg vs paliperidone palmitate at week 28 , there were significantly more Clinical Global Impression – Severity and Clinical Global Impression – Improvement responders ( adjusted odds ratio , 2.26 ; P=.010 , and 2.51 ; P=.0032 ) and significantly better Clinical Global Impression – Improvement scores ( least squares mean treatment difference , −0.326 ; 95 % CI , −0.60 to −0.05 ; P=.020 ) . Numerically larger improvements with aripiprazole once-monthly 400 mg vs paliperidone palmitate were observed for patient-rated scales Subjective Well-Being under Neuroleptic Treatment−short version and Tolerability and Quality of Life . Partial correlations were strongest among clinician-rated and among patient-rated scales but poorest between clinician and patient-rated scales . Conclusions Consistently greater improvements were observed with aripiprazole once-monthly 400 mg vs paliperidone palmitate across all measures . Partial correlations between scales demonstrate the multidimensionality of various measures of improvement . More patients on aripiprazole once-monthly 400 mg were deemed ready to work by the study end . Trial registry National Institutes of Health registry , NCT01795547 , https:// clinical trials.gov/ct2/ results ? id = NCT01795547 OBJECTIVE To directly compare aripiprazole once-monthly 400 mg ( AOM 400 ) and paliperidone palmitate once-monthly ( PP ) on the Heinrichs-Carpenter Quality -of-Life Scale ( QLS ) , a vali date d health-related quality of life and functioning measure in schizophrenia . METHOD This 28-week , r and omized , non-inferiority , open-label , rater-blinded , head-to-head study ( QUALIFY ) of AOM 400 and PP in adult patients ( 18 - 60 years ) comprised oral conversion , initiation of AOM 400 or PP treatment , and continuation with intramuscular injections every 4weeks . The primary endpoint assessed non-inferiority and superiority on QLS total score analyzed using a mixed model for repeated measurements . RESULTS Of 295 r and omized patients , 100/148 ( 67.6 % ) of AOM 400 and 83/147 ( 56.5 % ) of PP patients completed 28weeks of treatment . A statistically significant least squares mean difference in change from baseline to week 28 on QLS total score ( 4.67 [ 95%CI : 0.32;9.02 ] , p=0.036 ) confirmed non-inferiority and established superiority of AOM 400 vs PP . There were also significant improvements in Clinical Global Impression - Severity scale and the Investigator 's Assessment Question naire for AOM 400 vs PP , and pre-defined sub-group analyses revealed a consistent pattern of significance favoring AOM 400 in patients ≤35years . Common treatment-emergent adverse events in the treatment continuation phase were more frequent with PP vs AOM 400 , and adverse events were the most frequent reason for discontinuation ( 27/137 [ 19.7 % ] for PP and 16/144 [ 11.1 % ] for AOM 400 ) . All-cause discontinuation was numerically lower with AOM 400 . CONCLUSION Superior improvements on clinician-rated health-related quality of life and a favorable tolerability profile suggest greater overall effectiveness for aripiprazole once-monthly vs paliperidone palmitate . Clinical Trials.gov identifier : NCT01795547 This study assessed the efficacy and the safety of a dosing regimen that was revised from earlier studies for the investigational injectable atypical antipsychotic paliperidone palmitate ( approved in the USA , August 2009 ) for adult patients with acutely exacerbated schizophrenia . The patients ( N = 652 ) were r and omly assigned ( 1:1:1:1 ) to paliperidone palmitate at 25 , 100 , or 150 mg eq. or placebo in this 13-week double-blind study . The patients received an injection of paliperidone palmitate at 150 mg eq. or placebo in the deltoid muscle on day 1 and the assigned fixed dose or placebo in the deltoid or muscle on day 8 and then once monthly ( days 36 and 64 ) . No oral supplementation was used . Target plasma levels were achieved by day 8 in all paliperidone palmitate groups . The mean change in Positive and Negative Syndrome Scale total score from baseline to end point improved significantly ( P ≤ 0.034 ) in all the paliperidone palmitate dose-groups versus placebo . Paliperidone palmitate treatment with this revised dosing regimen led to the achievement of rapid and consistent therapeutically effective plasma levels that were maintained by once-monthly dosing in either the deltoid or gluteal muscle . Common treatment-emergent adverse events ( ≥2 % of patients in any of the treatment groups ) that occurred more frequently in the total paliperidone palmitate group versus the placebo group ( with ≥1 % difference ) were injection-site pain ( 7.6 % vs 3.7 % ) , dizziness ( 2.5 % vs 1.2 % ) , sedation ( 2.3 % vs 0.6 % ) , pain in the extremity ( 1.6 % vs 0.0 % ) , and myalgia ( 1.0 % vs 0.0 % ) . The paliperidone palmitate treatment was efficacious and generally tolerated across the dose range ( 25 , 100 , or 150 mg eq. ) in adult patients with acutely exacerbated schizophrenia . Abbreviations : BMI - body mass index , CGI-S - Clinical Global Impression-Severity , EPS - extrapyramidal symptoms , ER - extended release , ITT - intent-to-treat , LAI - long-acting injectable , PANSS - Positive and Negative Syndrome Scale , PK - pharmacokinetic , PSP - Personal and Social Performance Scale , TEAE - treatment-emergent adverse events , VAS - Visual Analogue OBJECTIVE The superiority of risperidone long-acting injection ( RLAI ) over oral typical and atypical antipsychotics demonstrated in previous studies may be related to the improved drug compliance . The aim of the 12-week r and omized , single-blind study was to test whether the superiority of RLAI remained among hospitalized patients that drug compliance could be optimally controlled . METHODS Fifty hospitalized stable schizophrenic patients , who had maintained on oral risperidone for more than 3 months , were r and omized to the RLAI and oral risperidone group . Finally 49 patients ( 98 % ) completed the study , and no dose change of oral risperidone , or RLAI was noted among all patients . RESULTS The RLAI group showed significantly increased positive score of Positive and Negative Syndrome Scale ( PANSS ) than the risperidone group ( 0.72 + /- 3.52 vs. -1.24 + /- 3.81 , p = 0.022 ) , but without significance difference for the PANSS total , negative and general psychopathology scores . The RLAI group also showed a significantly improved Udvalg for Kliniske Undersogelser ( UKU ) Scale ( p = 0.037 ) , social life domains of Short-Form Health Survey ( SF-36 ) ( p = 0.011 ) , and reduced prolactin level ( p = 0.001 ) . CONCLUSION The \n Output:\n " }, { "from": "agent", "value": "Poor psychosocial function was predicted by longer treatment duration , severe symptoms , poor cognition and poor insight .\nFunctioning was assessed by either a single or a combination of measures , but was not the primary outcome in most studies .\nConclusion : Long-acting injectable atypical antipsychotics are beneficial for recovery of psychosocial function in comparison with placebo , but the magnitude of superiority over oral antipsychotic treatment was small .\nSevere psychopathology at baseline predicted poor psychosocial function ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE It has been postulated that prasugrel might be the preferred treatment option in diabetes mellitus ( DM ) patients with acute coronary syndrome ( ACS ) undergoing percutaneous coronary intervention ( PCI ) . We aim ed to compare the pharmacodynamic action of ticagrelor versus prasugrel . RESEARCH DESIGN AND METHODS In a prospect i ve , single-center , single-blind , crossover study , 30 consecutive ACS patients with DM who had been pretreated with clopidogrel were r and omized to either 90 mg ticagrelor twice daily or 10 mg prasugrel once daily with a 15-day treatment period . Platelet reactivity ( PR ) was assessed with the VerifyNow P2Y12 function assay , measured in P2Y12 reaction units ( PRU ) . RESULTS PR was significantly lower after ticagrelor ( 45.2 PRU [ 95 % CI 27.4–63.1 ] ) compared with prasugrel ( 80.8 PRU [ 63.0–98.7 ] ) , with a least squares mean difference of –35.6 PRU ( −55.2 to −15.9 , P = 0.001 ) . High PR rate was 0 % for ticagrelor and 3.3 % for prasugrel ( P = 1.0 ) . CONCLUSIONS In DM patients with ACS who had been pretreated with clopidogrel and who undergo PCI , ticagrelor achieves a significantly higher platelet inhibition than prasugrel . Both antiplatelet agents effectively treat high PR . The relevance of these findings to the clinical efficacy and safety of ticagrelor and prasugrel in DM patients needs further elucidation BACKGROUND / PURPOSE Diabetes mellitus ( DM ) disproportionately affects Hispanic patients . DM patients have enhanced platelet reactivity and reduced sensitivity to clopidogrel . Ticagrelor demonstrated a more rapid onset and greater magnitude of platelet inhibition than clopidogrel in Hispanic patients with stable coronary artery disease ( CAD ) . This subgroup analysis examined the onset and level of platelet inhibition of ticagrelor and clopidogrel in Hispanic patients with DM . METHODS / MATERIAL S This was a subgroup analysis of a r and omized , open-label , crossover study in which 40 Hispanic patients with stable CAD received ticagrelor 180 mg loading dose (LD)/90 mg twice-daily maintenance dose ( MD ) then clopidogrel 600 mg LD/75 mg once-daily MD , or vice versa . The primary end point was on-treatment platelet reactivity at 2 hours post-LD using the VerifyNow ™ P2Y12 test . RESULTS 21 patients had DM and 19 were non-diabetic . At 2 hours post-LD , mean platelet reactivity in the diabetic group was 34.5 PRU with ticagrelor versus 219.3 PRU with clopidogrel ( P<0.001 ) , and in the non-diabetic group was 33.7 PRU with ticagrelor versus 181.0 PRU with clopidogrel ( P<0.001 ) . In both diabetic and non-diabetic subgroups , mean platelet reactivity declined to a significantly greater extent with ticagrelor than clopidogrel at all time points evaluated ( 0.5 , 2 , and 8 hours post LD and after 7 - 9 days of MD ) . Patients were significantly more likely to have high on-treatment platelet reactivity ( ≥208 PRU ) during treatment with clopidogrel compared with ticagrelor , regardless of diabetic status . CONCLUSIONS Among Hispanic patients with stable CAD , ticagrelor achieves a faster onset and greater magnitude of platelet inhibition compared with clopidogrel , irrespective of diabetic status OBJECTIVES Ticagrelor reduces thrombotic events compared with clopidogrel in patients with acute coronary syndrome , but may also increase bleeding complications . Coronary artery bypass grafting (CABG)-related bleeding complications have not previously been compared in clopidogrel and ticagrelor-treated patients outside the controlled environment of clinical trials . METHODS Four hundred and five consecutive CABG patients with acute coronary syndrome were included in a prospect i ve observational study . The patients were treated with aspirin and ticagrelor ( n = 173 ) or aspirin and clopidogrel ( n = 232 ) . Ticagrelor/clopidogrel was discontinued 5 days before surgery whenever deemed possible . Major bleeding complications according to modified blood conservation using antifibrinolytics in a r and omized trial criteria ( postoperative blood loss > 1500 ml/12 h , re-exploration , red blood cell transfusion > 10 units or death because of bleeding ) were compared in all patients and when ticagrelor/clopidogrel was discontinued ≥5 days ( n = 280 ) , 2 - 4 days ( n = 40 ) or 0 - 1 day before surgery ( n = 85 ) . RESULTS Major bleeding complications did not differ significantly between ticagrelor- and clopidogrel-treated patients when all patients were compared ( 14.5 vs 13.8 % , P = 0.89 ) . Likewise , there were no significant differences between ticagrelor and clopidogrel when either drug was discontinued ≥5 days before surgery ( 6.8 vs 9.9 % , P = 0.40 ) or 2 - 4 days before surgery ( 6.3 vs 25.0 % , P = 0.21 ) . When ticagrelor/clopidogrel was discontinued 0 - 1 day before surgery , there was a strong trend towards higher incidence of major bleeding in ticagrelor-treated patients ( 41.0 vs 21.7 % , P = 0.063 ) . CONCLUSIONS There was no difference in major bleeding complications overall or when ticagrelor or clopidogrel was used in accordance with guidelines . In patients on dual antiplatelet medication up to 1 day before surgery , there tended to be more bleeding complications in ticagrelor-treated patients BACKGROUND Dual-antiplatelet therapy with aspirin and a thienopyridine is a cornerstone of treatment to prevent thrombotic complications of acute coronary syndromes and percutaneous coronary intervention . METHODS To compare prasugrel , a new thienopyridine , with clopidogrel , we r and omly assigned 13,608 patients with moderate-to-high-risk acute coronary syndromes with scheduled percutaneous coronary intervention to receive prasugrel ( a 60-mg loading dose and a 10-mg daily maintenance dose ) or clopidogrel ( a 300-mg loading dose and a 75-mg daily maintenance dose ) , for 6 to 15 months . The primary efficacy end point was death from cardiovascular causes , nonfatal myocardial infa rct ion , or nonfatal stroke . The key safety end point was major bleeding . RESULTS The primary efficacy end point occurred in 12.1 % of patients receiving clopidogrel and 9.9 % of patients receiving prasugrel ( hazard ratio for prasugrel vs. clopidogrel , 0.81 ; 95 % confidence interval [ CI ] , 0.73 to 0.90 ; P<0.001 ) . We also found significant reductions in the prasugrel group in the rates of myocardial infa rct ion ( 9.7 % for clopidogrel vs. 7.4 % for prasugrel ; P<0.001 ) , urgent target-vessel revascularization ( 3.7 % vs. 2.5 % ; P<0.001 ) , and stent thrombosis ( 2.4 % vs. 1.1 % ; P<0.001 ) . Major bleeding was observed in 2.4 % of patients receiving prasugrel and in 1.8 % of patients receiving clopidogrel ( hazard ratio , 1.32 ; 95 % CI , 1.03 to 1.68 ; P=0.03 ) . Also greater in the prasugrel group was the rate of life-threatening bleeding ( 1.4 % vs. 0.9 % ; P=0.01 ) , including nonfatal bleeding ( 1.1 % vs. 0.9 % ; hazard ratio , 1.25 ; P=0.23 ) and fatal bleeding ( 0.4 % vs. 0.1 % ; P=0.002 ) . CONCLUSIONS In patients with acute coronary syndromes with scheduled percutaneous coronary intervention , prasugrel therapy was associated with significantly reduced rates of ischemic events , including stent thrombosis , but with an increased risk of major bleeding , including fatal bleeding . Overall mortality did not differ significantly between treatment groups . ( Clinical Trials.gov number , NCT00097591 [ Clinical Trials.gov ] . BACKGROUND Variation in and irreversibility of platelet inhibition with clopidogrel has led to controversy about its optimum dose and timing of administration in patients with acute coronary syndromes . We compared ticagrelor , a more potent reversible P2Y12 inhibitor with clopidogrel in such patients . METHODS At r and omisation , an invasive strategy was planned for 13 408 ( 72.0 % ) of 18 624 patients hospitalised for acute coronary syndromes ( with or without ST elevation ) . In a double-blind , double-dummy study , patients were r and omly assigned in a one-to-one ratio to ticagrelor and placebo ( 180 mg loading dose followed by 90 mg twice a day ) , or to clopidogrel and placebo ( 300 - 600 mg loading dose or continuation with maintenance dose followed by 75 mg per day ) for 6 - 12 months . All patients were given aspirin . The primary composite endpoint was cardiovascular death , myocardial infa rct ion , or stroke . Analyses were by intention to treat . This trial is registered with Clinical Trials.gov , number NCT00391872 . FINDINGS 6732 patients were assigned to ticagrelor and 6676 to clopidogrel . The primary composite endpoint occurred in fewer patients in the ticagrelor group than in the clopidogrel group ( 569 [ event rate at 360 days 9.0 % ] vs 668 [ 10.7 % ] , hazard ratio 0.84 , 95 % CI 0.75 - 0.94 ; p=0.0025 ) . There was no difference between clopidogrel and ticagrelor groups in the rates of total major bleeding ( 691 [ 11.6 % ] vs 689 [ 11.5 % ] , 0.99 [ 0.89 - 1.10 ] ; p=0.8803 ) or severe bleeding , as defined according to the Global Use of Strategies To Open occluded coronary arteries , ( 198 [ 3.2 % ] vs 185 [ 2.9 % ] , 0.91 [ 0.74 - 1.12 ] ; p=0.3785 ) . INTERPRETATION Ticagrelor seems to be a better option than clopidogrel for patients with acute coronary syndromes for whom an early invasive strategy is planned Background : No r and omized head-to-head comparison of the efficacy and safety of ticagrelor and prasugrel has been published in the 7 years since the higher efficacy of these newer P2Y12 inhibitors were first demonstrated relative to clopidogrel . Methods : This academic study was design ed to compare the efficacy and safety of prasugrel and ticagrelor in acute myocardial infa rct ion treated with primary or immediate percutaneous coronary intervention . A total of 1230 patients were r and omly assigned across 14 sites to either prasugrel or ticagrelor , which was initiated before percutaneous coronary intervention . Nearly 4 % were in cardiogenic shock , and 5.2 % were on mechanical ventilation . The primary end point was defined as death , reinfa rct ion , urgent target vessel revascularization , stroke , or serious bleeding requiring transfusion or prolonging hospitalization at 7 days ( to reflect primarily the in-hospital phase ) . This analysis presents data from the first 30 days ( key secondary end point ) . The total follow-up will be 1 year for all patients and will be completed in 2017 . Results : The study was prematurely terminated for futility . The occurrence of the primary end point did not differ between groups receiving prasugrel and ticagrelor ( 4.0 % and 4.1 % , respectively ; odds ratio , 0.98 ; 95 % confidence interval , 0.55–1.73 ; P=0.939 ) . No significant difference was found in any of the components of the primary end point . The occurrence of key secondary end point within 30 days , composed of cardiovascular death , nonfatal myocardial infa rct ion , or stroke , did not show any significant difference between prasugrel and ticagrelor ( 2.7 % and 2.5 % , respectively ; odds ratio , 1.06 ; \n Output:\n " }, { "from": "agent", "value": "Ticagrelor could reduce the incidence of composite endpoint of cardiovascular death , myocardial infa rct ion and stroke as well as platelet reactivity in DM patients with ACS , while not increasing the risk of bleeding ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective : Postoperative care for ankle fractures is generally 1 of 2 regimens : 1 ) functional treatment combined with early weightbearing ( EWB ) , or 2 ) immobilization in a cast/orthosis for 6 weeks without weightbearing ( 6WC ) . The objective of this study was 2-fold : 1 ) to follow a prospect i ve group treated with EWB as to long-term subjective and objective outcomes , and 2 ) to compare a subset of this group with a matched group of historic controls treated with 6WC . Design : Prospect i ve , clinical , cohort observation , and retrospective matched pair analysis . Setting : University hospital , level 1 trauma center . Patients : Forty-three patients ( 20 males ; mean age , 49 ± 14 years ) with operated Weber B/C fractures underwent EWB . For comparison , 23 patients of this group were matched to a same number of historic controls with respect to age , gender , body mass index , and fracture type . Intervention : Open reduction and internal fixation ( ORIF ) using a 1/3-tubular-fibula-plate for the fibula , and malleolar screws for the medial malleolus fracture ( in cases with a bimalleolar ankle fracture ) followed by EWB or 6WC . Main Outcome Measurements : Olerud and Tegner scores at follow-up ( at least 12 months after surgery ) , time to full weightbearing , return to work , pain intensity ( numerical rating scale ( NRS ) ) , and hospital stay . Statistical comparisons were performed by using the Mann-Whitney U test or Fisher exact test ( P < 0.05 ) . Results : Patients with EWB were full weightbearing at 7 ± 3 weeks and returned to work at 8 ± 5 weeks after surgery . At follow-up ( mean , 20 ± 11 months after surgery ) , all EWB patients showed good results in the Olerud score ( 90 ± 13 points ) . Matched-pair analysis in 23 patients in each group revealed differences between EWB and 6WC groups for hospital stay ( mean , 10.8 ± 4.7 vs. 13.6 ± 6 days ; P = 0.12 ) , time to full weightbearing ( mean , 7.7 ± 3.1 vs. 13.5 ± 9.4 weeks ; P = 0.01 ) , and time until return to work ( mean 9.2 ± 5.5 vs. 10.8 ± 7 weeks ; P = 0.63 ) . No differences concerning pain intensities were observed ( EWB vs. 6WC : NRS = 1.9 vs. 1.7 ; P = 0.12 ) . At follow-up , Olerud scores were generally considered good for both groups ; however , mean values in EWB patients were slightly higher ( 87 ± 14 vs. 79 ± 19 points ; P = 0.25 ) . In both groups , the majority of patients reached their preinjury level of activity as demonstrated by Tegner scores . Conclusions : EWB patients tolerated earlier full weightbearing compared with 6WC patients , and there were no disadvantages with EWB compared with 6WC concerning hospital stay , pain intensities , time until return to work , and Olerud/Tegner Scores . Potential c and i date s for EWB are patients with a stable osteo synthesis of their fractured ankles as judged by the responsible surgeon , compliance , and high motivation STUDY DESIGN Prospect i ve inception cohort study of 62 consecutive patients seen in 2 orthopaedic clinics following ankle fracture . OBJECTIVES To investigate 4 putative predictors ( age , fracture classification , acute management [ surgical or nonsurgical ] , and ankle dorsiflexion range of motion measured at the time of cast removal ) of outcome after ankle fracture and to develop simple predictive models of outcome after ankle fracture . BACKGROUND Ankle fracture is a common condition . However , few studies have investigated factors that predict outcome after ankle fracture . METHODS AND MEASURES Sixty-two consecutive subjects aged 17 or older with ankle fractures were recruited from 2 hospital orthopaedic clinics . Outcome measures recorded at 6 weeks and 6 months after cast removal included 2 functional question naires , patients ' ratings of global improvement , and a measure of ankle dorsiflexion . The predictive value of 4 variables selected a priori was analyzed using bivariate and stepwise multiple linear regression . RESULTS Ankle dorsiflexion and fracture classification predicted outcome 6 weeks and 6 months after cast removal for all outcome measures used ( P < .05 , r2 = 0.09 - 0.47 ) . Fracture management ( surgical or nonsurgical ) inconsistently predicted outcome at both 6 weeks and 6 months , and age did not predict outcome at either 6 weeks or 6 months after cast removal . The predictive models explain between 19 % and 58 % of the variance in outcomes 6 weeks after cast removal and 19 % to 52 % of the variance in outcomes 6 months after cast removal . CONCLUSION Ankle dorsiflexion measured at the time of cast removal and fracture classification are clinical ly significant predictors of outcome after ankle fracture ; however , much unexplained variation in outcomes still exists 40 patients with dislocated bimalleolar and trimalleolar ankle fractures took part in this r and omized study . All ankles were operated on using cerclage , staples and pins . Active ankle movement with weight bearing in an orthosis was compared with active ankle movement without weight bearing using a dorsal splint . Stereophotogrammetric analysis showed small movements in the ankle mortise in both groups but conventional radiography revealed no fracture redislocation . The clinical results did not differ . This study was design ed as the second part of a consecutive project . In the first part , early and late weight bearing in a cast without ankle movements was compared ( Ahl et al. 1987b ) . In comparing the first and the second parts of the study , a small but significant increase in fracture instability was observed in the early motion group . No lasting superior clinical result was achieved by early ankle movement . After operation on dislocated bimalleolar ankle fractures , early postoperative weight bearing in a walking cast is recommended Background Despite conflicting results after surgically treated ankle fractures few studies have evaluated the effects of different types of training programs performed after plaster removal . The aim of this study was to evaluate the effects of a 12-week st and ardised but individually suited training program ( training group ) versus usual care ( control group ) after plaster removal in adults with surgically treated ankle fractures . Methods In total , 110 men and women , 18 - 64 years of age , with surgically treated ankle fracture were included and r and omised to either a 12-week training program or to a control group . Six and twelve months after the injury the subjects were examined by the same physiotherapist who was blinded to the treatment group . The main outcome measure was the Olerud-Mol and er Ankle Score ( OMAS ) which rates symptoms and subjectively scored function . Secondary outcome measures were : quality of life ( SF-36 ) , timed walking tests , ankle mobility tests , muscle strength tests and radiological status . Results 52 patients were r and omised to the training group and 58 to the control group . Five patients dropped out before the six-month follow-up result ing in 50 patients in the training group and 55 in the control group . Nine patients dropped out between the six- and twelve-month follow-up result ing in 48 patients in both groups . When analysing the results in a mixed model analysis on repeated measures including interaction between age-group and treatment effect the training group demonstrated significantly improved results compared to the control group in subjects younger than 40 years of age regarding OMAS ( p = 0.028 ) , muscle strength in the plantar flexors ( p = 0.029 ) and dorsiflexors ( p = 0.030 ) . Conclusion The results of this study suggest that when adjusting for interaction between age-group and treatment effect the training model employed in this study was superior to usual care in patients under the age of 40 . However , as only three out of nine outcome measures showed a difference , the beneficial effect from an additional st and ardised individually suited training program can be expected to be limited . There is need for further studies to eluci date how a training program should be design ed to increase and optimise function in patients middle-aged or older . Trial Registration Current Controlled Trials OBJECTIVE The primary aim of this study was to determine the effectiveness and cost-effectiveness of adding manual therapy to a physiotherapy programme for ankle fracture . DESIGN Assessor-blinded r and omized controlled trial . PARTICIPANTS Ninety-four adults were recruited within one week of cast removal for isolated ankle fracture . Inclusion criteria were : they were able to weight-bear as tolerated or partial weight-bear , were referred for physiotherapy , and experienced pain . Ninety-one participants completed the study . METHODS Participants were r and omly allocated to receive manual therapy ( anterior-posterior joint mobilization over the talus ) plus a st and ard physiotherapy programme ( experimental ) , or the st and ard physiotherapy programme only ( control ) . They were assessed by a blinded assessor at baseline , and at 4 , 12 and 24 weeks . The main outcomes were activity limitation and quality of life . Information on costs and healthcare utilization was collected every 4 weeks up to 24 weeks . RESULTS There were no clinical ly worthwhile differences in activity limitation or quality of life between groups at any time-point . There was also no between-group difference in quality -adjusted life-years , but the experimental group incurred higher out-of-pocket costs ( mean between-group difference = AU$200 , 95 % confidence interval 26 - 432 ) . CONCLUSION When provided in addition to a physiotherapy programme , manual therapy did not enhance outcome in adults after ankle fracture In a prospect i ve , r and omized study , 30 patients were evaluated after ankle fracture treated by means of open reduction and internal fixation . The patients were r and omized to either postoperative immobilization in a plaster cast for 6 weeks or early mobilization ( 1–2 weeks after surgery ) in an ankle brace . Both regimens allowed weightbearing . Evaluation after 10 weeks and after 12 months included clinical assessment and isokinetic muscle strength measurements . Patients with impaired ankle function , as shown by means of an ankle score at 12 months , were followed for 3 years . At 10 weeks , impaired muscle torque and restricted range of motion was found on the affected side . This impairment was significantly less in the brace group . At 12 months , range of motion of the ankle and subtalar joints was restored , but dorsiflexion was still better in the brace group . Score values from a functional score did not correlate with muscle strength In a monocenter r and omized controlled trial , 45 patients with isolated malleolar fracture type OTA/AO 44 A1–B2 undergoing ORIF were allocated r and omly to a postoperative treatment either with a vacuum-stabilized orthesis with prescribed full weight bearing after the second week ( 23 patients ) ( orthesis group — OG ) or with functional aftertreatment with partial weight bearing of 15 kg for 6 weeks ( 22 patients ) ( control group — CG ) . Outcomes were compared at 6- and 10-week follow-up examinations . The Olerud and Mol and er ankle ( OMA ) score , ankle swelling , usage of crutches , range of motion , Short Form 12 , patient-reported visual analogue scales ( VAS ) ( pain , comfort , walking confidence ) and time to return to work were evaluated . All patients of OG showed reduced swelling at discharge . The median OMA scores after 6 weeks were 42 and 42.5 ( p = 0.46 ) and after 10 weeks 69 and 72 ( p = 0.55 ) in the OG and CG , respectively . The time to achieve secure walking capacity was reduced by 1 day ( p = 0.03 ) in the OG . After ORIF of simple malleolar fractures , patients with a vacuum-stabilized orthesis can bear full weight 2 weeks postoperatively . This group experienced no adverse events . Postoperative swelling was significantly reduced and of the ability to walk on stairs confidently was shorter as compared to a functional aftertreatment without any external stabilization of the ankle In the prospect i ve cohort study reported here , we used the Short Musculoskeletal Function Assessment ( SMFA ) question naire to assess rate of return of functional outcome after open reduction and internal fixation of unstable ankle fractures ( Orthopaedic Trauma Association/Arbeitsgemeinschaft für Osteosynthesefragen [ OTA/AO ] 44B and 44C ) at a level II trauma center over the course of 1 year . The entire group of 69 consecutive adults improved significantly ( P<.01 ) on the SMFA Emotional Status and Dysfunction scales from 2 to 4 months and on the Mobility and Daily Activities scales from 2 to 4 months and from 4 to 6 months . There were no significant changes on the Arm/H and Function and Bother scales . There was a significant effect of age on Mobility , Daily Activities , and Dysfunction , with older patients ( > or = 50 years ) obtaining higher ( worse ) scores . There was no significant effect on patient sex on any of the scales . Patients with 44C fractures ( vs 44B fractures ) had significantly ( P = .05 ) higher mean Bother scores at 6 months . There were no significant differences arising from presence or absence of a fracture of the medial malleolus . Our SMFA data show that older \n Output:\n " }, { "from": "agent", "value": "Studies with older participants and predominantly male participants tended to report worse functional outcomes ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background : Dance and yoga have been shown to produce improvements in psychological well-being . Purpose : The aim of this study was to examine some of the psychological and neuroendocrine responses to these activities . Methods : Sixty-nine healthy college students participated in one of three 90-min classes : African dance ( n = 21 ) , Hatha yoga ( n = 18 ) , or a biology lecture as a control session ( n = 30 ) . Before and after each condition participants completed the Perceived Stress Scale ( PSS ) , completed the Positive Affect and Negative Affect Schedule , and provided a saliva sample for cortisol . Results : There were significant reductions in PSS and negative affect ( ps < .0001 ) and Time × Treatment interactions ( ps < .0001 ) such that African dance and Hatha yoga showed significant declines , whereas there was no significant change in biology lecture . There was no significant main effect for positive affect ( p = .53 ) , however there was a significant interaction effect ( p < .001 ) such that positive affect increased in African dance , decreased in biology lecture , and did not change significantly in Hatha yoga . There was a significant main effect for salivary cortisol ( p < .05 ) and a significant interaction effect ( p < .0001 ) such that cortisol increased in African dance , decreased in Hatha yoga , and did not change in biology . Changes in cortisol were not significantly related to changes in psychological variables across treatments . There was 1 significant interaction effect ( p = .04 ) such that change in positive affect and change in cortisol were negatively correlated in Hatha yoga but positively correlated in African dance and biology . Conclusions : Both African dance and Hatha yoga reduced perceived stress and negative affect . Cortisol increased in African dance and decreased in Hatha yoga . Therefore , even when these interventions produce similar positive psychological effects , the effects may be very different on physiological stress processes . One factor that may have particular salience is the amount of physiological arousal produced by the intervention Smith 's ( 2001 ) Attentional Behavioral Cognitive ( ABC ) relaxation theory proposes that all approaches to relaxation ( including music ) have the potential for evoking one or more of 15 factor-analytically derived relaxation states , or \" R-States \" ( Sleepiness , Disengagement , Rested / Refreshed , Energized , Physical Relaxation , At Ease/Peace , Joy , Mental Quiet , Childlike Innocence , Thankfulness and Love , Mystery , Awe and Wonder , Prayerfulness , Timeless/Boundless/Infinite , and Aware ) . The present study investigated R-States and stress symptom-patterns associated with listening to Mozart versus New Age music . Students ( N = 63 ) were divided into three relaxation groups based on previously determined preferences . Fourteen listened to a 28-minute tape recording of Mozart 's Eine Kleine Nachtmusik and 14 listened to a 28-minute tape of Steven Halpern 's New Age Serenity Suite . Others ( n = 35 ) did not want music and instead chose a set of popular recreational magazines . Participants engaged in their relaxation activity at home for three consecutive days for 28 minutes a session . Before and after each session , each person completed the Smith Relaxation States Inventory ( Smith , 2001 ) , a comprehensive question naire tapping 15 R-States as well as the stress states of somatic stress , worry , and negative emotion . Results revealed no differences at Session 1 . At Session 2 , those who listened to Mozart reported higher levels of At Ease/Peace and lower levels of Negative Emotion . Pronounced differences emerged at Session 3 . Mozart listeners uniquely reported substantially higher levels of Mental Quiet , Awe and Wonder , and Mystery . Mozart listeners reported higher levels , and New Age listeners slightly elevated levels , of At Ease/Peace and Rested/Refreshed . Both Mozart and New Age listeners reported higher levels of Thankfulness and Love . In summary , those who listened to Mozart 's Eine Kleine Nachtmusik reported more psychological relaxation and less stress than either those who listened to New Age music or read popular recreational magazines . Results suggest the usefulness of ABC relaxation theory in comparing the different effects of music and relaxation techniques Objective : Negative symptoms of patients with Schizophrenia are resistant to medical treatment or conventional group therapy . Underst and ing schizophrenia as a form of disembodiment of the self , a number of scientists have argued that the approach of embodiment and associated embodied therapies , such as Dance and Movement Therapy ( DMT ) or Body Psychotherapy ( BPT ) , may be more suitable to explain the psychopathology underlying the mental illness and to address its symptoms . Hence the present r and omized controlled trial ( DRKS00009828 , http://apps.who.int/trial search / ) aim ed to examine the effectiveness of manualized movement therapy ( BPT/DMT ) on the negative symptoms of patients with schizophrenia . Method : A total of 68 out- patients with a diagnosis of a schizophrenia spectrum disorder were r and omly allocated to either the treatment ( n = 44 , 20 sessions of BPT/DMT ) or the control condition [ n = 24 , treatment as usual ( TAU ) ] . Changes in negative symptom scores on the Scale for the Assessment of Negative Symptoms ( SANS ) were analyzed using Analysis of Covariance ( ANCOVA ) with Simpson-Angus Scale ( SAS ) scores as covariates in order to control for side effects of antipsychotic medication . Results : After 20 sessions of treatment ( BPT/DMT or TAU ) , patients receiving movement therapy had significantly lower negative symptom scores ( SANS total score , blunted affect , attention ) . Effect sizes were moderate and mean symptom reduction in the treatment group was 20.65 % . Conclusion : The study demonstrates that embodied therapies , such as BPT/DMT , are highly effective in the treatment of patients with schizophrenia . Results strongly suggest that BPT/DMT should be embedded in the daily clinical routine Objective : This study evaluated whether harp therapy reduces levels of stress and improves clinical outcomes in patients undergoing embryo transfer . Design : This prospect i ve r and omized trial enrolled 181 women undergoing embryo transfer , who were r and omized to harp therapy during embryo transfer or st and ard treatment . Patients underwent st and ardized psychological testing and physiologic assessment of stress . Setting : The study was conducted in a reproductive medicine practice . Results : No statistically significant differences were found in the heart and respiratory rates , nor was there a significant difference in event-based anxiety at baseline . Harp therapy had a significantly larger decrease in state anxiety from pre– to post – embryo transfer . Clinical pregnancy was 53 % versus 48 % for the harp therapy and st and ard treatment groups , respectively . Conclusion : Harp therapy decreases state , or event-based , anxiety , significantly lowering state scores posttransfer and having a positive effect on acute levels of stress . There was an increased pregnancy rate , but larger sample sizes are needed to evaluate whether harp therapy has an effect on clinical outcomes BACKGROUND Work with families and families at risk within the field of music therapy have been developing for the last decade . To diminish risk for unhealthy child development , families with emotionally neglected children need help to improve their emotional communication and develop healthy parent-child interactions . While some research ers have investigated the effect of music therapy on either the parent or the child , no study has investigated the effect of music therapy on the observed interaction between the parent and child within the field of child protection . OBJECTIVE The purpose of this study was to investigate the effect of a dyadic music therapy intervention on observed parent-child interaction ( mutual attunement , nonverbal communication , emotional parental response ) , self-reported parenting stress , and self-reported parent-child relationship in families at risk and families with emotionally neglected children , ages 5 - 12 years . METHOD This was a r and omized controlled trial study conducted at a family care center in Denmark . Eighteen parent-child dyads were r and omly assigned to receive 10 weekly music therapy sessions with a credentialed music therapist ( n = 9 ) or treatment as usual ( n = 9 ) . Observational measures for parent-child interaction , self-reported measures for parenting stress and parent-child relationship were completed at baseline and 4 months post-baseline assessment . RESULTS Results of the study showed that dyads who received music therapy intervention significantly improved their nonverbal communication and mutual attunement . Similarly , parents who participated in dyadic music therapy reported themselves to be significantly less stressed by the mood of the child and to significantly improve their parent-child relationship in terms of being better at talking to and underst and ing their children than parents who did not receive music therapy . Both groups significantly improved in terms of increased positive and decreased negative emotional parental response , parenting stress and stress in general . There were no significant between group differences in self-perceived autonomy , attachment , and parental competence . CONCLUSIONS The dyadic music therapy intervention examined in this study improved emotional communication between parent and child and interaction after 6 to 10 sessions and can be considered as a viable treatment alternative or supplement for families at risk and families with emotionally neglected children AIMS AND OBJECTIVES The purpose of this study was to examine the effects of music therapy on stress , anxiety and depression in Taiwanese pregnant women . BACKGROUND The value of music therapy is slowly being realized by nurses in various clinical areas , including obstetrics . Previous studies have demonstrated a high prevalence of psychological stress during pregnancy . Few studies have examined the effects of music therapy on reducing psychological stress during pregnancy . DESIGN A r and omized experimental study design was developed and implemented . METHODS Two hundred and thirty-six pregnant women were r and omly assigned to music therapy ( n = 116 ) and control ( n = 120 ) groups . The music therapy group received two weeks of music intervention . The control group received only general prenatal care . Psychological health was assessed using three self-report measures : Perceived Stress Scale ( PSS ) , State Scale of the State-Trait Anxiety Inventory ( S-STAI ) and Edinburgh Postnatal Depression Scale ( EPDS ) . RESULTS In a paired t-test , the music therapy group showed significant decrease in PSS , S-STAI and EPDS after two weeks . The control group only showed a significant decrease in PSS after two weeks . This decrease was not as substantial as in the experimental group . An ancova test with the pretest scores as the control revealed that the changes in PSS , S-STAI and EPDS after two weeks were significantly decreased in the experimental group compared with the control group . CONCLUSIONS This controlled trial provides preliminary evidence that two-week music therapy during pregnancy provides quantifiable psychological benefits . RELEVANCE TO CLINICAL PRACTICE The findings can be used to encourage pregnant women to use this cost-effective method of music in their daily life to reduce their stress , anxiety and depression . Further research is needed to test the long-term benefits OBJECTIVES To determine whether tango dancing is as effective as mindfulness meditation in reducing symptoms of psychological stress , anxiety and depression , and in promoting well-being . DESIGN This study employed analysis of covariance ( ANCOVA ) and multiple regression analysis . PARTICIPANTS Ninety-seven people with self-declared depression were r and omised into tango dance or mindfulness meditation classes , or to control/waiting-list . SETTING classes were conducted in a venue suitable for both activities in the metropolitan area of Sydney , Australia . INTERVENTIONS Participants completed six-week programmes ( 1½h/week of tango or meditation ) . The outcome measures were assessed at pre-test and post-test . MAIN OUTCOME MEASURES Depression , Anxiety and Stress Scale ; The Self Esteem Scale ; Satisfaction with Life Scale , and Mindful Attention Awareness Scale . RESULTS Sixty-six participants completed the program and were included in the statistical analysis . Depression levels were significantly reduced in the tango ( effect size d=0.50 , p=.010 ) , and meditation groups ( effect size d=0.54 , p=.025 ) , relative to waiting-list controls . Stress levels were significantly reduced only in the tango group ( effect size d=0.45 , p=.022 ) . Attending tango classes was a significant predictor for the increased levels of mindfulness R(2)=.10 , adjusted R(2)=.07 , F (2,59)=3.42 , p=.039 . CONCLUSION Mindfulness-meditation and tango dance could be effective complementary adjuncts for the treatment of depression and /or inclusion in stress management programmes . Subsequent trials are called to explore the therapeutic mechanisms involved PURPOSE To test the efficacy of a creative arts intervention ( CAI ) with family caregivers of patients with cancer . DESIGN A pre-posttest quasi-experimental design , with participation in the CAI as the independent variable and stress , anxiety , and emotions as the dependent variables . METHOD The 6-month study was implemented at a regional cancer treatment center with family caregivers . The CAI consisted of several creative arts activities design ed for delivery at the bedside . FINDINGS Forty family caregivers reported significantly reduced stress , lowered anxiety , and increased positive emotions following CAI participation . CONCLUSIONS The CAI promoted short-term well being in this family caregiver sample . Caregivers also increased positive communication with cancer patients and health care providers while expressing delight over their h and made pieces of art BACKGROUND Long-term stress-related sick leave constitutes a serious health threat and an economic burden on both the single worker and the society . Effective interventions for the rehabilitation and facilitation of return to work are needed . OBJECTIVE The aim of the study was to examine the effects of Guided Imagery and Music ( GIM ) , a psychotherapy intervention including relaxation , music listening , and imagery , on biopsychosocial measures of work-related stress . MET \n Output:\n " }, { "from": "agent", "value": "81.1 % of the included studies reported a significant reduction of stress in the participants due to interventions of one of the four arts modalities" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: PURPOSE To determine overall survival , progression-free survival , rate of voice preservation , and patterns of failure in locoregionally advanced laryngeal cancer treated with induction chemotherapy with or without surgery followed by concomitant chemoradiation . BACKGROUND Locoregionally advanced laryngeal cancer has been conventionally treated with either surgery and adjuvant radiotherapy or radiotherapy alone , and clinical and functional outcomes have been poor . Chemoradiotherapy has been demonstrated to improve functional outcome and disease control over conventional treatment in recent r and omized head and neck trials . PATIENTS AND METHODS Advanced head and neck cancer patients were enrolled onto two consecutive phase II studies . Induction treatment consisted of three cycles of cisplatin , 5-fluorouracil ( 5-FU ) , leucovorin , and interferon-alpha 2b ( PFL-IFN ) followed by surgery for residual disease . Surgical intent was to spare the larynx when possible . All patients then proceeded to concomitant chemoradiation consisting of seven or eight cycles of 5-FU , hydroxyurea , and a planned total radiotherapy dose of 7000 cGy ( FHX ) . RESULTS A subset of thirty-two laryngeal cancer patients with predominantly stage IV disease comprises the study group for this report . Clinical CR was observed in 59 % of patients following induction therapy . The median follow-up was 63.0 months for surviving patients and 44.5 months for all patients . At five years , overall survival is 47 % , progression-free survival is 78 % , and locoregional control is 78 % . No distant failures were observed . Voice preservation with disease control was 75 % at five years . Only two total laryngectomies were performed during the course of treatment and follow-up . Treatment-related toxicity accounted for two deaths . CONCLUSIONS The addition of concomitant chemoradiotherapy to induction chemotherapy for locoregionally advanced laryngeal cancer appears to increase locoregional control and survival rates . PFL-IFN-FHX result ed in high rates of disease cure and voice preservation in a group of patients that has traditionally fared poorly in both clinical and functional outcome PURPOSE Taxane-based concurrent chemoradiotherapy ( CCR ) for head and neck cancers has proven to have a favorable toxicity profile compared with cisplatin and radiation . This phase II multi-institutional trial evaluates taxane-based induction chemotherapy followed by CCR for organ preservation in resectable stage III/IVA and IVB larynx and oropharynx ( OP ) cancer patients . PATIENTS AND METHODS Eligibility required resectable stage T2N+ , or T3-T4N0 - 3M0 biopsy-proven squamous carcinoma , age at least 18 years , PS 0 to 2 , good organ function , and no prior chemotherapy or radiation . Treatment was induction paclitaxel 175 mg/m(2 ) and carboplatin area under the concentration-time curve ( AUC ) 6 for two cycles every 21 days followed by concurrent paclitaxel 30 mg/m(2 ) every 7 days with 70 Gy if no evidence of tumor progression . Weekly erythropoietin alpha 40 kU was used for suboptimal hemoglobin ( < 14 gm/dL men , < 13 gm/dL women ) . The primary end point was organ preservation ( freedom from primary site salvage surgery or primary tumor recurrence ) . RESULTS One hundred five of 111 patients ( 36 larynx , 69 OP ) were eligible . Median follow-up was 36.7 months . Ninety-four percent received full-dose radiotherapy and 91 % received at least five cycles of concurrent paclitaxel . No patient progressed while receiving chemotherapy . Organ preservation was 81 % at 2 years after completion of therapy ( larynx 74 % , OP 84 % ) . Thirteen patients required primary -site salvage surgery ( seven larynx , six OP ) , and six of these have progressed and died ( three larynx , three OP ) . Thirteen patients developed distant metastases ( seven larynx , six OP ; P = .02 ) and 10 of 36 larynx and 11 of 69 OP patients have died as a result of their disease . Two-year survival is 76 % ( 63 % larynx v 83 % OP ) . CONCLUSION A high organ preservation rate was obtained with this regimen for OP but not for larynx patients . Toxicity was low , and induction chemotherapy did not preclude delivery of concurrent chemoradiotherapy PURPOSE The efficacy and toxicity of neoadjuvant chemotherapy followed by radiotherapy and concurrent chemoradiotherapy and their impact on larynx preservation have been studied in patients with advanced ( stage III , IVa , and IVb ) squamous cell cancer of the larynx . PATIENTS AND METHODS Fifty patients were treated with either 2 - 4 cycles of induction chemotherapy with cisplatin 100 mg/m(2 ) , day 1 and infusional 5-fluorouracil ( 5-FU 1000 mg/m(2 ) , days 1 - 5 ) , followed by radiotherapy 70 Gy , 1.8 - 2 Gy per fraction , or concurrent chemoradiotherapy ( the above-mentioned radiotherapy concurrently with carboplatin 300 mg/m(2 ) every 21 days or weekly paclitaxel 80 mg/m(2 ) ) . Patients were allocated in the 2 arms by 1:1 selection . At the end of both protocol s , patients without complete response ( CR ) underwent laryngectomy and /or neck lymph node dissection . Assessed were response and toxicity rates , overall survival ( OS ) and disease-free survival ( DFS ) . RESULTS A total of 31 ( 62 % ) patients achieved larynx preservation with acceptable organ function . No statistically significant difference in response rate and OS was found between the two treatment arms . Patients su bmi tted to concurrent chemoradiotherapy showed significantly longer DFS ( 14 vs. 10 months , p= 0.0397 ) and higher rates of larynx preservation ( p < 0.05 ) . All grade IV side effects occurred in the concurrent chemoradiotherapy group . CONCLUSION Concurrent compared to alternating chemoradiotherapy was more toxic , but achieved significantly longer DFS and higher rate of larynx preservation BACKGROUND Locally advanced laryngeal and hypopharyngeal cancers ( LHC ) represent a group of cancers for which surgery , laryngectomy-free survival ( LFS ) , overall survival ( OS ) , and progression-free survival ( PFS ) are clinical ly meaningful end points . PATIENTS AND METHODS These outcomes were analyzed in the subgroup of assessable LHC patients enrolled in TAX 324 , a phase III trial of sequential therapy comparing docetaxel plus cisplatin and fluorouracil ( TPF ) against cisplatin and fluorouracil ( PF ) , followed by chemoradiotherapy . RESULTS Among 501 patients enrolled in TAX 324 , 166 had LHC ( TPF , n = 90 ; PF , n = 76 ) . Patient characteristics were similar between subgroups . Median OS for TPF was 59 months [ 95 % confidence interval ( CI ) : 31-not reached ] versus 24 months ( 95 % CI : 13 - 42 ) for PF [ hazard ratio ( HR ) for death : 0.62 ; 95 % CI : 0.41 - 0.94 ; P = 0.024 ] . Median PFS for TPF was 21 months ( 95 % CI : 12 - 59 ) versus 11 months ( 95 % CI : 8 - 14 ) for PF ( HR : 0.66 ; 95 % CI : 0.45 - 0.97 ; P = 0.032 ) . Among operable patients ( TPF , n = 67 ; PF , n = 56 ) , LFS was significantly greater with TPF ( HR : 0.59 ; 95 % CI : 0.37 - 0.95 ; P = 0.030 ) . Three-year LFS with TPF was 52 % versus 32 % for PF . Fewer TPF patients had surgery ( 22 % versus 42 % ; P = 0.030 ) . CONCLUSIONS In locally advanced LHC , sequential therapy with induction TPF significantly improved survival and PFS versus PF . Among operable patients , TPF also significantly improved LFS and PFS . These results support the use of sequential TPF followed by carboplatin chemoradiotherapy as a treatment option for organ preservation or to improve survival in locally advanced LHC BACKGROUND We performed a prospect i ve , r and omized study in patients with previously untreated advanced ( Stage III or IV ) laryngeal squamous carcinoma to compare the results of induction chemotherapy followed by definitive radiation therapy with those of conventional laryngectomy and postoperative radiation . METHODS Three hundred thirty-two patients were r and omly assigned to receive either three cycles of chemotherapy ( cisplatin and fluorouracil ) and radiation therapy or surgery and radiation therapy . The clinical tumor response was assessed after two cycles of chemotherapy , and patients with a response received a third cycle followed by definitive radiation therapy ( 6600 to 7600 cGy ) . Patients in whom ther was no tumor response or who had locally recurrent cancers after chemotherapy and radiation therapy underwent salvage laryngectomy . RESULTS After two cycles of chemotherapy , the clinical tumor response was complete in 31 percent of the patients and partial in 54 percent . After a median follow-up of 33 months , the estimated 2-year survival was 68 percent ( 95 percent confidence interval , 60 to 76 percent ) for both treatment groups ( P = 0.9846 ) . Patterns of recurrence differed significantly between the two groups , with more local recurrences ( P = 0.0005 ) and fewer distant metastases ( P = 0.016 ) in the chemotherapy group than in the surgery group . A total of 59 patients in the chemotherapy group ( 36 percent ) required total laryngectomy . The larynx was preserved in 64 percent of the patients overall and 64 percent of the patients who were alive and free of disease . CONCLUSIONS These preliminary results suggest a new role for chemotherapy in patients with advanced laryngeal cancer and indicate that a treatment strategy involving induction chemotherapy and definitive radiation therapy can be effective in preserving the larynx in a high percentage of patients , without compromising overall survival AIM Survival in head and neck cancers reflect loco-regional control . With an aim of organ and function preservation the present study was undertaken to compare local failure and survivals . MATERIAL AND METHODS Between August 1991-December 1995 , 72 patients with resectable advanced supraglottic cancers , were r and omized to radical surgery followed by post-operative radiation therapy ( Sx+PORT ) ( Arm I ) or radical radiation therapy followed by salvage surgery ( RRT+/-SSx ) ( Arm II ) . RESULTS Sixty-four of 72 patients were evaluable , 55 were T3 ( 86 % ) and 9 were T4 ( 14 % ) tumors . In Arm I ( n=35 ) with a mean follow-up of 24 months ( 2 - 86 months ) , 21 patients were alive without disease . Six patients had recurrence , one each at local and tracheostomy stoma , four had nodal recurrence only , and two developed 2nd primary in soft palate/tonsil and parotid at 15 and 18 months respectively . In Arm II ( n=29 ) , with a mean follow-up of 24 months ( 3 - 81 months ) , 14 patients were alive without disease . Thirteen patients had recurrence , eight had local ( one patient had persistent disease ) , two nodal only , three loco-regional and two patients developed distant metastasis ( lung ) . One out of eight local recurrence and 2/2 nodal recurrences were salvaged with Sx . There was a significant difference in disease-free survival between the two treatment arms , DFS ( 5 years ) of 70 % in Arm I vs 50 % in Arm II ( p=0.04 ) , but did not have any impact on overall survival OAS ( 5 years ) ; 73 % vs 77 % ( p=0.79 ) . Voice/laryngeal preservation was possible in 18/29 patients ( 62 % ) treated with RRT+/- Sx , without significantly affecting the OAS . \" Pathological upstaging \" was another significant finding seen in 64 % of clinical T3 after radical surgery . CONCLUSION RRT+/-SSx can be a feasible option in low volume , favourable resectable stage III and IV supraglottic lesions for better quality of life BACKGROUND AND PURPOSE To compare in a phase III study the loco-regional control , disease-free survival and overall survival induced by an accelerated regimen ( AF ) as compared with conventional regimen ( CF ) and to analyze the early and late post-radiation morbidity in both arms . MATERIAL S AND METHODS Patients with age < or = 75 , WHO 0 - 1 , suitable for a radical course of radiotherapy T1-T3 , N0 , M0 , stage of glottic and supraglottic laryngeal cancer were r and omized to either CF : 66Gy given in 33 fractions over 45 days or \n Output:\n " }, { "from": "agent", "value": "Conclusion These findings suggest that of the larynx-preserving treatments , RT alone was associated with highest rates of OS , DFS , and LFS in patients with locally advanced cancer of the larynx and hypopharynx .\nLaryngectomy provided a better rate of DFS than CT and RT , but OS were similar across the different larynx-preserving treatments and laryngectomy" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: PURPOSE To determine if photodynamic therapy with verteporfin ( Visudyne ; Novartis AG , Bülach , Switzerl and ) , termed verteporfin therapy , can safely reduce the risk of vision loss compared with a placebo ( with sham treatment ) in patients with subfoveal choroidal neovascularization caused by age-related macular degeneration who were identified with a lesion composed of occult with no classic choroidal neovascularization , or with presumed early onset classic choroidal neovascularization with good visual acuity letter score . METHODS This was a double-masked , placebo-controlled ( sham treatment ) , r and omized , multicenter clinical trial involving 28 ophthalmology practice s in Europe and North America . The study population was patients with age-related macular degeneration , with subfoveal choroidal neovascularization lesions measuring no greater than 5400 microm in greatest linear dimension with either 1 ) occult with no classic choroidal neovascularization , best-corrected visual acuity score of at least 50 ( Snellen equivalent approximately 20/100 ) , and evidence of hemorrhage or recent disease progression ; or 2 ) evidence of classic choroidal neovascularization with a best-corrected visual acuity score of at least 70 ( better than a Snellen equivalent of approximately 20/40 ) ; assigned r and omly ( 2:1 ) to verteporfin therapy or placebo therapy . Verteporfin ( 6 mg per square meter of body surface area ) or placebo ( 5 % dextrose in water ) was administered by means of intravenous infusion of 30 ml over 10 minutes . Fifteen minutes after the start of the infusion , a laser light at 689 nm delivered 50 J/cm(2 ) by application of an intensity of 600 mW/cm(2 ) over 83 seconds using a spot size with a diameter 1000 microm larger than the greatest linear dimension of the choroidal neovascularization lesion on the retina . At follow-up examinations every 3 months , retreatment with the same regimen was applied if angiography showed fluorescein leakage . The main outcome measure was at least moderate vision loss , that is , a loss of at least 15 letters ( approximately 3 lines ) , adhering to an intent-to-treat analysis with the last observation carried forward to impute for missing data . RESULTS Two hundred ten ( 93 % ) and 193 ( 86 % ) of the 225 patients in the verteporfin group compared with 104 ( 91 % ) and 99 ( 87 % ) of the 114 patients in the placebo group completed the month 12 and 24 examinations , respectively . On average , verteporfin-treated patients received five treatments over the 24 months of follow-up . The primary outcome was similar for the verteporfin-treated and the placebo-treated eyes through the month 12 examination , although a number of secondary visual and angiographic outcomes significantly favored the verteporfin-treated group . Between the month 12 and 24 examinations , the treatment benefit grew so that by the month 24 examination , the verteporfin-treated eyes were less likely to have moderate or severe vision loss . Of the 225 verteporfin-treated patients , 121 ( 54 % ) compared with 76 ( 67 % ) of 114 placebo-treated patients lost at least 15 letters ( P = .023 ) . Likewise , 67 of the verteporfin-treated patients ( 30 % ) compared with 54 of the placebo-treated patients ( 47 % ) lost at least 30 letters ( P = .001 ) . Statistically significant results favoring verteporfin therapy at the month 24 examination were consistent between the total population and the subgroup of patients with a baseline lesion composition identified as occult choroidal neovascularization with no classic choroidal neovascularization . This subgroup included 166 of the 225 verteporfin-treated patients ( 74 % ) and 92 of the 114 placebo-treated patients ( 81 % ) . In these patients , 91 of the verteporfin-treated group ( 55 % ) compared with 63 of the placebo-treated group ( 68 % ) lost at least 15 letters ( P = .032 ) , whereas 48 of the verteporfin-treated group ( 29 % ) and 43 of the placebo-treated group ( 47 % ) lost at least 30 letters ( P = .004 ) . Other secondary outcomes , including visual acuity letter score worse than 34 ( approximate Snellen equivalent of 20/200 or worse ) , mean change in visual acuity letter score , development of classic choroidal neovascularization , progression of classic choroidal neovascularization and size of lesion , favored the verteporfin-treated group at both the month 12 and month 24 examination for both the entire study group and the subgroup of cases with occult with no classic choroidal neovascularization at baseline . Subgroup analyses of lesions composed of occult with no classic choroidal neovascularization at baseline suggested that the treatment benefit was greater for patients with either smaller lesions ( 4 disc areas or less ) or lower levels of visual acuity ( letter score less than 65 , an approximate Snellen equivalent of 20/50(-1 ) or worse ) at baseline . Prospect ively planned multivariable analyses confirmed that these two baseline variables affected the magnitude of treatment benefit . ( ABSTRACT TRUNCATED OBJECTIVE To report 24-month vision and fluorescein angiographic outcomes from trials evaluating photodynamic therapy with verteporfin ( Visudyne ; CIBA Vision Corp , Duluth , Ga ) in patients with subfoveal choroidal neovascularization ( CNV ) caused by age-related macular degeneration ( AMD ) . DESIGN Two multicenter , double-masked , placebo-controlled , r and omized clinical trials . SETTING Twenty-two ophthalmology practice s in Europe and North America . PARTICIPANTS Patients with subfoveal CNV lesions caused by AMD with greatest linear dimension on the retina measuring 5400 micrometer or less , with evidence of classic CNV and best-corrected visual acuity ( approximate Snellen equivalent ) between 20/40 and 20/200 . METHODS The methods were similar to those described in our 1-year results , with follow-up examinations beyond 1 year continuing every 3 months ( except for Photograph Reading Center evaluations , which occurred only at month 18 and month 24 examinations ) . During the second year , the same regimen ( with verteporfin or placebo as applied at baseline ) was used if angiography showed fluorescein leakage from CNV . The primary outcome was the proportion of eyes with fewer than 15 letters ( approximately 3 lines ) of visual acuity loss at the month 24 examination , adhering to an intent-to-treat analysis . The last observation was carried forward to impute for any missing data . RESULTS Three hundred fifty-one ( 87 % ) of 402 patients in the verteporfin group compared with 178 ( 86 % ) of 207 patients in the placebo group completed the month 24 examination . Beneficial outcomes with respect to visual acuity and contrast sensitivity noted at the month 12 examination in verteporfin-treated patients were sustained through the month 24 examination . At the month 24 examination for the primary outcome , 213 ( 53 % ) of 402 verteporfin-treated patients compared with 78 ( 38 % ) of 207 placebo-treated patients lost fewer than 15 letters ( P<.001 ) . In subgroup analyses for predominantly classic lesions ( in which the area of classic CNV makes up at least 50 % of the area of the entire lesion ) at baseline , 94 ( 59 % ) of 159 verteporfin-treated patients compared with 26 ( 31 % ) of 83 placebo-treated patients lost fewer than 15 letters at the month 24 examination ( P<.001 ) . For minimally classic lesions ( in which the area of classic CNV makes up < 50 % but > 0 % of the area of the entire lesion ) at baseline , no statistically significant differences in visual acuity were noted . Few additional photosensitivity adverse reactions and injection site adverse events were associated with verteporfin therapy in the second year of follow-up . CONCLUSIONS The visual acuity benefits of verteporfin therapy for AMD patients with predominantly classic CNV subfoveal lesions are safely sustained for 2 years , providing more compelling evidence to use verteporfin therapy for these cases . For AMD patients with subfoveal lesions that are minimally classic , there is insufficient evidence to warrant routine use of verteporfin therapy OBJECTIVE To report vision and safety outcomes from an extension of a 2-year investigation evaluating verteporfin photodynamic therapy in patients with age-related macular degeneration with subfoveal choroidal neovascularization ( CNV ) . DESIGN AND SETTING Open-label extension of selected patients from 2 multicenter , double-masked , placebo-controlled , r and omized clinical trials , the Treatment of Age-Related Macular Degeneration With Photodynamic Therapy ( TAP ) Investigation , at 22 ophthalmology practice s in Europe and North America . PARTICIPANTS Patients enrolled in the TAP Investigation and followed up for at least 24 months in whom verteporfin therapy to CNV might reduce the risk of further vision loss . METHODS Before receiving verteporfin therapy in the extension , eligible patients signed a written informed consent form accompanied by an oral consent process approved by local institutional review boards . Methods were similar to those described for 1- and 2-year results , with follow-up examinations beyond 2 years continuing at 3-month intervals with a few exceptions , including that extension patients with fluorescein leakage from CNV were to receive open-label verteporfin therapy irrespective of their original treatment assignment . RESULTS Of 402 patients in the verteporfin group , 351 ( 87.3 % ) completed the month 24 examination ; 320 ( 91.2 % ) of these enrolled in the extension study . The enrolled participants included 124 ( 78.0 % ) of the 159 verteporfin-treated patients with lesions composed of predominantly classic CNV at baseline , of whom 105 ( 84.7 % ) completed the month 36 examination . Verteporfin-treated patients with this lesion composition at baseline who participated in the extension study , with or without a month 36 examination , appeared more likely to have a younger age , better level of visual acuity , absence of fluorescein leakage from classic CNV , or no progression of classic CNV beyond the baseline boundaries of the lesion at the month 24 examination compared with those who did not enroll in the extension . For the 105 patients with a predominantly classic baseline lesion composition who completed the month 36 examination , an average of 1.3 treatments were given from the month 24 examination up to , but not including , the month 36 examination . A letter score loss in the study eye of at least 15 from baseline for these patients occurred in 39 ( 37.5 % ) at the month 24 examination compared with 44 ( 41.9 % ) of these patients at the month 36 examination . Visual acuity changed little from the month 24 examination ( mean , -1.9 lines ) to the month 36 examination ( mean , -2.0 lines ) for these eyes . Verteporfin-treated patients had little change in the mean visual acuity lost and few or no additional instances of infusion-related back pain or photosensitivity reactions from month 24 to month 36 . Two patients originally assigned to placebo had acute severe vision decrease within 7 days after verteporfin treatment during the extension . One patient originally assigned to verteporfin had acute severe vision decrease after verteporfin treatment of the fellow eye during the extension . CONCLUSIONS Vision outcomes for verteporfin-treated patients with predominantly classic lesions at baseline remained relatively stable from month 24 to month 36 , although only approximately one third of the verteporfin-treated patients originally enrolled with this lesion composition had a month 36 examination . From these results , the TAP Study Group identified no safety concerns to preclude repeating photodynamic therapy with verteporfin . Additional treatment was judged likely to reduce the risk of further vision loss . Caution appears warranted in the absence of comparison with an untreated group during the extension and since not all patients in the TAP Investigation participated in the TAP Extension OBJECTIVE To determine if photodynamic therapy with verteporfin ( Visudyne ; CIBA Vision Corp , Duluth , GA ) can improve the chance of stabilizing or improving vision ( < 8 letter loss ) safely in patients with subfoveal choroidal neovascularization ( CNV ) caused by pathologic myopia . DESIGN Multicenter , double-masked , placebo-controlled , r and omized clinical trial at 28 ophthalmology practice s in Europe and North AMERICA : PARTICIPANTS One hundred twenty patients with subfoveal CNV caused by pathologic myopia with a greatest linear dimension no more than 5400 microM and best-corrected visual acuity ( Snellen equivalent ) of approximately 20/100 or better . INTERVENTION Patients were r and omly assigned ( 2:1 ) to verteporfin ( 6 mg per square meter of body surface area ; n = 81 ) or placebo ( 5 % dextrose in water ; n = 39 ) \n Output:\n " }, { "from": "agent", "value": "Subgroup analyses suggest that the benefits may be confined to people with no occult choroidal neovascularisation .\nREVIEW ER 'S CONCLUSIONS Photodynamic therapy in people with classic choroidal neovascularisation due to age-related macular degeneration is effective in preventing visual loss .\nThere is no evidence that photodynamic therapy is beneficial for people with evidence of occult choroidal neovascularisation ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: UNLABELLED Chinese research indicates that the Qigong method reduces psychosomatic and physical symptoms through an effect on the sympathetic nervous system . OBJECTIVES The aim was to investigate the effects of Qigong on stress among computer operators . DESIGN Ten women were included in a Qigong group and an equal number in a control group . Heart rate , blood pressure , and finger temperature were measured at the beginning and at the end of the working day during 5 weeks . twenty four-hours urine sample s were collected in the first and last weeks to measure catecholamine excretion in urine . Participants kept a daily record of psychological measures of strain and weekly measures of stress levels . RESULTS AND CONCLUSIONS Qigong reduced noradrenaline excretion in urine ( p<0.05 ) , and influenced the heart rate and temperature , indicating reduced activity of the sympathetic nervous system . Moreover , Qigong reduced low-back symptoms ( p<0.05 ) . In conclusion , Qigong exercise may reduce stress at computerised work OBJECTIVE Based on individual cases of treatment , we were interested in whether the effects of a special kind of qigong , the \" White Ball \" exercises , can be objectified by physically measurable parameters and psychological scores . METHODS We performed a preliminary prospect i ve controlled interventional study with the waiting list design . In the qigong group eight children were included . They received specific qigong lessons of the \" White Ball \" qigong over seven weeks , twice a week , for 30 min with a waiting list design and instructions to perform the same exercises at home daily . In the control group eight children were included in a waiting list design with no qigong instruction . Subjective perception of anxiety was measured by the Portuguese version of the Depression , Anxiety and Stress Scale adapted for children . In addition , salivary cortisol , heart rate variability , blood pressure , surface electromyography of the trapezius muscle and reaction time were measured at the beginning and the end of the study prior to the regular public auditions . RESULTS In comparison to the changes in the control group , the qigong group scored significantly lower in heart rate . Otherwise the groups did not differ significantly ; however , the effect size was large for salivary cortisol , surface electromyography of the trapezius muscle and blood pressure . There were relevant reductions of subjective perception of anxiety , salivary cortisol levels and heart rate . CONCLUSION The heart rate of performing schoolchildren can be potentially reduced by \" White Ball \" exercises . Based on a sample of 8/8 , positive tendencies were also observed for anxiety and blood pressure . The next steps of objectifying possible qigong effects are to increase the sample size , to study young people in other situations arousing anxiety , to develop an appropriate control intervention , to solve the problem of blinding and double blinding , to find additional parameters that may be influenced by the \" White Ball \" qigong , and to compare the qigong effects with other methods reducing anxiety such as more traditional biofeedback or systematic desensitization OBJECTIVE The aim of this study was to investigate the effectiveness of a qigong training program in reducing stress in hospital staff . METHODS Subjects were r and omly assigned to a 6-week intervention of either qigong practice ( n = 16 ) or a waiting list ( n = 21 ) . The primary measure of stress was the Perceived Stress Scale . Secondary measures included the Short Form 36 ( SF-36 ) quality -of-life measure and a 100-mm analog pain scale . RESULTS The qigong group demonstrated a statistically significant reduction of perceived stress compared to the control group ( p = 0.02 ) . On the Social Interaction subscale of the SF-36 , the qigong group demonstrated greater improvement compared to controls ( p = 0.04 ) . Within-groups analyses demonstrated that the qigong group ( p = 0.03 ) , but not the control group , experienced a significant reduction of pain intensity . A regression analysis demonstrated an association between higher baseline stress levels and greater improvement within the qigong group ( R(2 ) = 0.34 ; p = 0.02 ) . CONCLUSIONS These results suggest that short-term exposure to qigong was effective in reducing stress in hospital staff . Further studies are needed to evaluate the possible effectiveness of qigong in reducing pain and in improving quality of life Background Distressed individuals in Korea may benefit from the practice of mind – body exercises such as Qigong . However , the effectiveness of such techniques needs to be investigated . Methods Fifty participants who were eligible to this study were r and omized into a group receiving a 4-week intervention of a brief Qigong-based stress reduction program ( BQSRP ) or a wait-list control group . Before and after the intervention period , saliva sample s were collected and question naires were completed on perceived stress , anxiety , “ Hwa-Byung ” ( anger syndrome ) , and quality of life . Salivary cortisol has emerged in mind-body therapy research as an easy-to-collect , relatively inexpensive , biologic marker of stress . Salivary corisol were collected to evaluate physiological effect of BQSRP . Between-group comparisons of change from baseline to study completion were analyzed by analysis of covariance for the Perceived Stress Scale and independent two sample t- tests for other measures . Results Compared with the control group , the BQSRP intervention group displayed significantly larger decreases in Perceived Stress Scale scores ( p = 0.0006 ) , State Anxiety scores ( p = 0.0028 ) , Trait Anxiety scores ( p < 0.0001 ) , personality subscale scores of the Hwa-Byung Scale ( p = 0.0321 ) , symptoms scores of the Hwa-Byung Scale ( p = 0.0196 ) , and a significantly larger increase in World Health Organization Quality of Life Abbreviated version scores ( p s < .05 ) . Salivary cortisol levels were not changed . Conclusions The BQSRP appears to be effective in reducing stress perception , anxiety , anger , and improving quality of life ( KCT0000056 ) OBJECTIVES Psychologic problems is increasing among pupils and has become a major problem in Sweden as well as in other Western countries . The aim of this study was to explore whether scheduled qigong exercise could have an effect on well-being at school , psychologic distress , self-image , and general stress . SUBJECTS Pupils , 13 - 14 years , were assigned to either a qigong group or a control group . INTERVENTION The qigong group had scheduled qigong 2 times a week for 8 weeks . MEASURES Self-reported well-being at school , psychologic distress , self-image , and stress were measured pre- and postintervention . RESULTS The control group had reduced well-being at school during the semester and the qigong group was stable . The qigong group reduced psychologic distress and stress , and had a tendency to improved self-image , whereas no changes were found in the control group . Self-image explains 47 % ( R(2 ) = 0.47 ) of well-being at school , and stress explains 29 % ( R(2 ) = 0.29 ) of psychologic distress . CONCLUSIONS Scheduled qigong , meditative movement , is a possible way to improve well-being at school BACKGROUND Qigong is a Chinese health promoting exercise with a rhythmic pattern of slow movements and breathing affecting the autonomous nervous system . OBJECTIVES To examine the implementation of Qigong for half an hour daily in a computerised office , and to study effects on health state , general health , neck-shoulder and lumbar spine symptoms and stress after six weeks training DESIGN A crossover intervention study with 37 employees r and omised in two groups . A question naire was completed one week before starting study and every second week during the training period . After 6 weeks the first group stopped and the second group started the training . RESULTS There was a small significant improvement of neck pain and disability following therapy . CONCLUSION Qigong training may reduce neck disability in office workers . A longer training period might be needed in further Qigong studies in healthy , normal population Qigong exercise has been shown to induce acute psychological changes of a positive nature ; but whether longer duration s have greater effects than shorter ones is not known . Forty-one regular qigong practitioners therefore engaged in either 30 or 60 min of qigong exercise within a r and omized cross-over design . Measures of mood , anxiety , activation , and hedonic tone were obtained pre- and post-exercise . Results showed benefits of the same magnitude in the two conditions : more positive mood states , reduced state anxiety , and enhanced perceived pleasure . Thirty minutes of qigong exercise thereby seems to be sufficient to provide psychological benefits , and with no additional benefits detected after 60 min . This finding is important for those having little time or motivation to engage in activities of longer duration s. In addition , health professionals prescribing exercise for health benefits can prescribe shorter exercise sessions with confidence knowing that positive psychological effects can also occur after a shorter exercise bout This cross-sectional investigation evaluated the trend of psychological changes by ChunDoSunBup ( CDSB ) Qi-training using a self-report inventory of emotional distress , Symptom Check List-90-Revision ( SCL-90-R ) . 41 normal healthy subjects ( mean age = 20.98 + /- 5.39 ) and 123 CDSB Qi-trainees ( divided into three groups , Q1 , Q2 and Q3 ) participated in this study . Group Q1 has received 1 - 4 months CDSB Qi-training ( age 21.95 + /- 7.82 , n = 41 ) ; Q2 has 5 - 12 months Qi-training ( age 20.0 + /- 7.75 , n = 41 ) ; and Q3 has more than 13 months Qi-training ( age 22.68 + /- 6.72 , n = 41 ) . Our results show that Qi-trainees over 13 months had significantly lower scores compared to controls . A significant negative correlation was found between the Qi-training period and all SCL-90-R subscales except phobic anxiety . These results suggest that CDSB Qi-training is effective in protection as well as reduction of psychological symptomatology \n Output:\n " }, { "from": "agent", "value": "Conclusions The available evidence suggests that qigong exercise reduces stress and anxiety in healthy adults ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE In a platelet/endothelial biomarker sub study of the Sertraline AntiDepressant Heart Attack R and omized Trial ( SADHART ) , the authors sought to determine whether plasma levels of sertraline and its primary metabolite N-desmethylsertraline affect the release of platelet/endothelial biomarkers . METHOD Fifty-five acute coronary syndrome patients with depression were r and omly assigned to receive sertraline ( N=23 ) or placebo ( N=32 ) . Twenty-six serial plasma sample s collected at week 6 ( N=12 ) and week 16 ( N=14 ) were analyzed . Platelet factor 4 ( PF4 ) , beta-thromboglobulin ( beta-TG ) , platelet/endothelial cell adhesion molecule 1 ( PECAM-1 ) , P-selectin , thromboxane B(2 ) ( TxB(2 ) ) , prostacyclin ( 6-keto-PGF1alpha ) , vascular cell adhesion molecule 1 ( VCAM-1 ) , and E-selectin were measured by enzyme-linked immunosorbent assay . Concentrations of sertraline and N-desmethylsertraline were determined by liquid chromatography with fluorescence detection in autologous sample s. RESULTS Strong , mostly time-dependent negative correlations were found for the plasma levels of sertraline and N-desmethylsertraline with PF4 ( week 6 : r=-0.69 and -0.33 , respectively ; week 16 : r=-0.63 for both ) , beta-TG ( week 6 : r=-0.43 and -0.29 ; week 16 : r=-0.66 and -0.57 ) , PECAM-1 ( week 6 : r=-0.82 and -0.49 ; week 16 : r=-0.60 for both ) , P-selectin ( week 6 : r=-0.82 and -0.49 ; week 16 : r=-0.73 and -0.43 ) , and TxB(2 ) ( week 6 : r=-0.66 and -0.59 ; and week 16 : r=-0.64 and -0.41 ) . Regression analysis revealed some borderline correlations for endothelial markers such as 6-keto- PGF1alpha and E-selectin and a positive correlation for VCAM-1 . CONCLUSIONS This is the first documented evidence that plasma release of platelet/endothelial biomarkers is directly related to the levels of sertraline and N-desmethylsertraline in acute coronary syndrome patients receiving SSRI treatment for depression . The clinical significance of these findings should be assessed in the setting of a r and omized clinical trial CONTEXT Depression and low perceived social support ( LPSS ) after myocardial infa rct ion ( MI ) are associated with higher morbidity and mortality , but little is known about whether this excess risk can be reduced through treatment . OBJECTIVE To determine whether mortality and recurrent infa rct ion are reduced by treatment of depression and LPSS with cognitive behavior therapy ( CBT ) , supplemented with a selective serotonin reuptake inhibitor ( SSRI ) antidepressant when indicated , in patients enrolled within 28 days after MI . DESIGN , SETTING , AND PATIENTS R and omized clinical trial conducted from October 1996 to April 2001 in 2481 MI patients ( 1084 women , 1397 men ) enrolled from 8 clinical centers . Major or minor depression was diagnosed by modified Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition criteria and severity by the 17-item Hamilton Rating Scale for Depression ( HRSD ) ; LPSS was determined by the Enhancing Recovery in Coronary Heart Disease Patients ( ENRICHD ) Social Support Instrument ( ESSI ) . R and om allocation was to usual medical care or CBT-based psychosocial intervention . INTERVENTION Cognitive behavior therapy was initiated at a median of 17 days after the index MI for a median of 11 individual sessions throughout 6 months , plus group therapy when feasible , with SSRIs for patients scoring higher than 24 on the HRSD or having a less than 50 % reduction in Beck Depression Inventory scores after 5 weeks . MAIN OUTCOME MEASURES Composite primary end point of death or recurrent MI ; secondary outcomes included change in HRSD ( for depression ) or ESSI scores ( for LPSS ) at 6 months . RESULTS Improvement in psychosocial outcomes at 6 months favored treatment : mean ( SD ) change in HRSD score , -10.1 ( 7.8 ) in the depression and psychosocial intervention group vs -8.4 ( 7.7 ) in the depression and usual care group ( P<.001 ) ; mean ( SD ) change in ESSI score , 5.1 ( 5.9 ) in the LPSS and psychosocial intervention group vs 3.4 ( 6.0 ) in the LPSS and usual care group ( P<.001 ) . After an average follow-up of 29 months , there was no significant difference in event-free survival between usual care ( 75.9 % ) and psychosocial intervention ( 75.8 % ) . There were also no differences in survival between the psychosocial intervention and usual care arms in any of the 3 psychosocial risk groups ( depression , LPSS , and depression and LPSS patients ) . CONCLUSIONS The intervention did not increase event-free survival . The intervention improved depression and social isolation , although the relative improvement in the psychosocial intervention group compared with the usual care group was less than expected due to substantial improvement in usual care patients CONTEXT Depressive symptoms predict adverse cardiovascular outcomes in patients with coronary heart disease , but the mechanisms responsible for this association are unknown . OBJECTIVE To determine why depressive symptoms are associated with an increased risk of cardiovascular events . DESIGN AND PARTICIPANTS The Heart and Soul Study is a prospect i ve cohort study of 1017 out patients with stable coronary heart disease followed up for a mean ( SD ) of 4.8 ( 1.4 ) years . SETTING Participants were recruited between September 11 , 2000 , and December 20 , 2002 , from 12 outpatient clinics in the San Francisco Bay Area and were followed up to January 12 , 2008 . MAIN OUTCOME MEASURES Baseline depressive symptoms were assessed using the Patient Health Question naire ( PHQ ) . We used proportional hazards models to evaluate the extent to which the association of depressive symptoms with subsequent cardiovascular events ( heart failure , myocardial infa rct ion , stroke , transient ischemic attack , or death ) was explained by baseline disease severity and potential biological or behavioral mediators . RESULTS A total of 341 cardiovascular events occurred during 4876 person-years of follow-up . The age-adjusted annual rate of cardiovascular events was 10.0 % among the 199 participants with depressive symptoms ( PHQ score > or = 10 ) and 6.7 % among the 818 participants without depressive symptoms ( hazard ratio [ HR ] , 1.50 ; 95 % confidence interval , [ CI ] , 1.16 - 1.95 ; P = .002 ) . After adjustment for comorbid conditions and disease severity , depressive symptoms were associated with a 31 % higher rate of cardiovascular events ( HR , 1.31 ; 95 % CI , 1.00 - 1.71 ; P = .04 ) . Additional adjustment for potential biological mediators attenuated this association ( HR , 1.24 ; 95 % CI , 0.94 - 1.63 ; P = .12 ) . After further adjustment for potential behavioral mediators , including physical inactivity , there was no significant association ( HR , 1.05 ; 95 % CI , 0.79 - 1.40 ; P = .75 ) . CONCLUSION In this sample of out patients with coronary heart disease , the association between depressive symptoms and adverse cardiovascular events was largely explained by behavioral factors , particularly physical inactivity CONTEXT There has been little research on the treatment of depression after coronary artery bypass surgery . OBJECTIVE To test the efficacy of 2 nonpharmacological interventions for depression after coronary artery bypass surgery compared with usual care . DESIGN A 12-week , r and omized , single-blind clinical trial with outcome evaluations at 3 , 6 , and 9 months . SETTING Outpatient research clinic at Washington University School of Medicine , St Louis , Missouri . PATIENTS One hundred twenty-three patients who met the DSM-IV criteria for major or minor depression within 1 year after surgery . INTERVENTION Twelve weeks of cognitive behavior therapy or supportive stress management . Approximately half of the participants were taking non study antidepressant medications . MAIN OUTCOME MEASURE Remission of depression , defined as a score of less than 7 on the 17-item Hamilton Rating Scale for Depression . RESULTS Remission of depression occurred by 3 months in a higher proportion of patients in the cognitive behavior therapy ( 71 % ) and supportive stress-management ( 57 % ) arms than in the usual care group ( 33 % ) ( chi(2)(2 ) = 12.22 , P = .002 ) . Covariate-adjusted Hamilton scores were lower in the cognitive behavior therapy ( mean [ st and ard error ] , 5.5 [ 1.0 ] ) and the supportive stress-management ( 7.8 [ 1.0 ] ) arms than in the usual care arm ( 10.7 [ 1.0 ] ) at 3 months . The differences narrowed at 6 months , but the remission rates differed again at 9 months ( 73 % , 57 % , and 35 % , respectively ; chi(2)(2 ) = 12.02 , P = .003 ) . Cognitive behavior therapy was superior to usual care at most points on secondary measures of depression , anxiety , hopelessness , stress , and quality of life . Supportive stress management was superior to usual care only on some of the measures . CONCLUSIONS Both cognitive behavior therapy and supportive stress management are efficacious for treating depression after coronary artery bypass surgery , relative to usual care . Cognitive behavior therapy had greater and more durable effects than supportive stress management on depression and several secondary psychological outcomes . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00042198 Background —Depression after acute coronary syndromes ( ACSs ) has been identified as an independent risk factor for subsequent cardiac death . Enhanced platelet activation has been hypothesized to represent 1 of the mechanisms underlying this association . Selective serotonin reuptake inhibitors ( SSRIs ) are known to inhibit platelet activity . Whether treatment of depressed post-ACS patients with SSRIs alters platelet function was not known . Accordingly , we serially assessed the release of established platelet/endothelial biomarkers in patients treated with sertraline vs placebo in the Sertraline AntiDepressant Heart Attack R and omized Trial ( SADHART ) . Methods and Results —Plasma sample s ( baseline , week 6 , and week 16 ) were collected from patients r and omized to sertraline ( n=28 ) or placebo ( n=36 ) . Anticoagulants , aspirin , and ADP-receptor inhibitors were permitted in this study . Platelet factor 4 , & bgr;-thromboglobulin ( & bgr;TG ) , platelet/endothelial cell adhesion molecule-1 , P-selectin , thromboxane B2 , 6-ketoprostagl and in F1a , vascular cell adhesion molecule-1 , and E-selectin were measured by ELISA . Treatment with sertraline was associated with substantially less release of platelet/endothelial biomarkers than was treatment with placebo . These differences attained statistical significance for & bgr;TG ( P = 0.03 ) at weeks 6 and 16 and for P-selectin ( P = 0.04 ) at week 16 . Repeated- measures ANOVA revealed a significant advantage for sertraline vs placebo for diminishing E-selectin and & bgr;TG concentrations across the entire treatment period . Conclusions —Treatment with sertraline in depressed post-ACS patients is associated with reductions in platelet/endothelial activation despite coadministration of widespread antiplatelet regimens including aspirin and clopidogrel . The antiplatelet and endothelium-protective properties of SSRIs might represent an attractive additional advantage in patients with depression and comorbid coronary artery and /or cerebrovascular disease This study investigated the effects of antidepressant treatment on platelet activation in depressed patients with ischemic heart disease ( IHD ) . Plasma levels of platelet alpha-granule release products beta-thromboglobulin ( BTG ) and platelet factor 4 ( PF4 ) were measured in 17 depressed patients with IHD who were treated in a 6-week , double-blind trial with either paroxetine ( 10 patients ) or nortriptyline ( 7 patients ) . Baseline measurements of BTG and PF4 were significantly elevated in both drug treatment groups before the initiation of antidepressant therapy compared with those of healthy control subjects . In the paroxetine group , mean PF4 and BTG levels significantly decreased from these elevated baseline values within 1 week of treatment and remained low at 3- and 6- \n Output:\n " }, { "from": "agent", "value": "Based on one trial per outcome , no beneficial effects on mortality rates , cardiac events , cardiovascular hospitalizations and QoL were found , except for the psychosocial dimension of QoL. Furthermore , no differences on treatment outcomes were found between the varying psychological approaches .\nPsychological interventions and pharmacological interventions with SSRIs may have a small yet clinical ly meaningful effect on depression outcomes in CAD patients .\nNo beneficial effects on the reduction of mortality rates and cardiac events were found ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE This study was design ed to prospect ively compare helical CT with pulmonary angiography in the detection of pulmonary embolism in patients with an unresolved clinical and scintigraphic diagnosis . SUBJECTS AND METHODS Twenty patients with an unresolved suspicion of pulmonary embolism were evaluated with contrast-enhanced helical CT and with selective pulmonary angiography . An average of 11 hr separated the two studies . The CT scans were obtained during one 24-sec or two 12-sec breath-holds . CT scans were interpreted without knowledge of the results of scintigraphy or angiography . Selective pulmonary angiograms were obtained with knowledge of the findings on the ventilation/perfusion scan only . The sensitivity and specificity of CT were compared with those of angiography for central vessels ( segmental and larger ) only and for all vessels . RESULTS Eleven of the 20 patients had proved pulmonary embolism ( seven in central vessels and four in subsegmental vessels only ) . When only central vessels were analyzed , CT sensitivity was 86 % , specificity was 92 % , and the likelihood ratio was 10.7 . However , when subsegmental vessels were included , CT results were 63 % , 89 % , and 5.7 , respectively . CONCLUSION In our subset of patients , helical CT was only 63 % sensitive . Subsegmental emboli are difficult to diagnose . Pulmonary angiography remains the study of choice . CT has a limited role in the evaluation of acute pulmonary embolism Background —Serial ultrasonography is reliable for the diagnosis of deep venous thrombosis in symptomatic patients , but the low prevalence of thrombosis in this group renders the approach costly and inconvenient to patients . We studied the clinical validity of the combination of a pretest clinical probability score and a D-dimer test in the initial evaluation of patients suspected of deep venous thrombosis . Methods and Results — Patients with a normal D-dimer concentration ( < 500 fibrin equivalent units [ FEU ] & mgr;g/L ) and a non-high probability score ( <3 ) had no further testing . Patients with a normal D-dimer concentration and a high probability score ( ≥3 ) underwent one ultrasonogram . Serial ultrasonography was performed in patients with an abnormal D-dimer concentration . Patients were followed for 3 months . A total of 812 patients were evaluable for efficacy . Only 1 of 176 patients ( 0.6 % ; 95 % CI , 0.02 % to 3.1 % ) with a normal D-dimer concentration and a non-high probability score developed thrombosis during follow-up . A normal D-dimer concentration and a high probability score were found in 39 patients ; 3 of them ( 7.7 % ; 95 % CI , 1.6 % to 20.9 % ) had thrombosis at presentation , and one ( 2.8 % ; 95 % CI , 0.07 % to 14 . 5 % ) developed pulmonary embolism during follow-up . In 306 of 597 patients ( 51.3 % ) with an abnormal D-dimer concentration , thrombosis was detected by serial ultrasonography . Six patients ( 2.1 % ; 95 % CI , 0.8 % to 4 . 4 % ) developed thrombosis during follow-up . No deaths due to thromboembolism occurred during follow-up . The total need for ultrasonography was reduced by 29 % . Conclusion —The combination of a non-high pretest clinical probability score and a normal D-dimer concentration is a safe strategy to rule out deep venous thrombosis and to withhold anticoagulation OBJECTIVE To vali date the predictive value of the Canadian clinical probability model for acute venous thrombosis , which , to the best of the authors ' knowledge , has not been done in emergency department ( ED ) setting s outside of Canada . METHODS Demographic and clinical information , rapid D-dimer testing , and venous ultrasound imaging were obtained among patients presenting with clinical ly suspected venous thrombosis at a university-affiliated ED . A diagnosis of deep venous thrombosis ( DVT ) was made based on venous ultrasound test results or objective ly documented venous thromboembolism during a 12-week follow-up period . The probability of venous thrombosis was calculated using the Canadian clinical probability model . RESULTS Among 102 patients , 17 ( 17 % ) were diagnosed as having venous thrombosis initially or during the three-month follow-up period . The frequency of venous thrombosis among patients categorized as having high probability was 10 of 17 [ 59 % , 95 % confidence interval ( 95 % CI ) = 35 % to 82 % ] , 6 of 44 ( 14 % , 95 % CI = 4 % to 24 % ) with intermediate probability , and 1 of 41 ( 2 % , 95 % CI = 0.1 % to 11 % ) with low probability . This compares with respective values of 49 % , 14 % , and 3 % , reported by Canadian research ers in an ED study . Forty-one of 102 ( 40 % ) patients had an alternate diagnosis as likely or more likely than venous thrombosis , but only three ( 7 % , 95 % CI = 2 % to 18 % ) of these had venous thrombosis . CONCLUSIONS Use of the Canadian probability model for DVT in this ED result ed in effective risk stratification , comparable to previously published results PURPOSE Although clinical examination has been reported to be unreliable in the diagnosis of deep vein thrombosis ( DVT ) , this conclusion has often been derived from hospitalized patients ( HP ) and may not be applicable in an outpatient setting . This study was undertaken to define clinical parameters that might predict the diagnostic value of emergency venous duplex scanning ( VDS ) . METHODS Venous duplex scans performed over a 9-month period ( interval I ) in 154 out patients ( 154 limbs ) and 145 HP ( 145 limbs ) with suspected DVT were review ed . RESULTS Eighteen percent of scans of out patients and 31 % of scans of HP were interpreted as positive for lower extremity DVT . With stepwise logistic regression analysis , criteria predictive of a negative result of outpatient VDS included ( 1 ) duration of symptoms greater than 7 days ( p = 0.003 ) , ( 2 ) thigh circumference difference relative to the uninvolved side of less than 3 cm ( p = 0.001 ) , and ( 3 ) no history of neoplasia ( p = 0.03 ) . This model , when applied prospect ively to 68 out patients ( 68 limbs ) over the next 5 months ( interval II ) , yielded a negative predictive value ( NPV ) of 96.7 % ( sensitivity 90.9 % , specificity 50.9 % , positive predictive value 26.3 % ) . Of the 222 out patients examined during intervals I and II , 98 ( 44 % ) met these three clinical criteria . Three of these 98 out patients had DVT on VDS and thus would have been misclassified as having a negative result . With a similar logistic regression analysis for HP , clinical criteria achieved an NPV of only 75 % ( sensitivity 36 % , specificity 90 % , positive predictive value 62 % ) . CONCLUSION Clinical assessment is unreliable in the diagnostic evaluation of HP with suspected DVT . In an outpatient population , however , clinical evaluation with the above criteria achieved an NPV of 96.7 % in the diagnosis of DVT . These parameters may be useful as guidelines in determining the appropriateness of emergency outpatient VDS We have previously demonstrated that a clinical model can be safely used in a management strategy in patients with suspected pulmonary embolism ( PE ) . We sought to simplify the clinical model and determine a scoring system , that when combined with D-dimer results , would safely exclude PE without the need for other tests , in a large proportion of patients . We used a r and omly selected sample of 80 % of the patients that participated in a prospect i ve cohort study of patients with suspected PE to perform a logistic regression analysis on 40 clinical variables to create a simple clinical prediction rule . Cut points on the new rule were determined to create two scoring systems . In the first scoring system patients were classified as having low , moderate and high probability of PE with the proportions being similar to those determined in our original study . The second system was design ed to create two categories , PE likely and unlikely . The goal in the latter was that PE unlikely patients with a negative D-dimer result would have PE in less than 2 % of cases . The proportion of patients with PE in each category was determined overall and according to a positive or negative SimpliRED D-dimer result . After these determinations we applied the models to the remaining 20 % of patients as a validation of the results . The following seven variables and assigned scores ( in brackets ) were included in the clinical prediction rule : Clinical symptoms of DVT ( 3.0 ) , no alternative diagnosis ( 3.0 ) , heart rate > 100 ( 1.5 ) , immobilization or surgery in the previous four weeks ( 1.5 ) , previous DVT/PE ( 1.5 ) , hemoptysis ( 1.0 ) and malignancy ( 1.0 ) . Patients were considered low probability if the score was < 2.0 , moderate of the score was 2.0 to 6.0 and high if the score was over 6.0 . Pulmonary embolism unlikely was assigned to patients with scores < or = 4.0 and PE likely if the score was > 4.0 . 7.8 % of patients with scores of less than or equal to 4 had PE but if the D-dimer was negative in these patients the rate of PE was only 2.2 % ( 95 % CI = 1.0 % to 4.0 % ) in the derivation set and 1.7 % in the validation set . Importantly this combination occurred in 46 % of our study patients . A score of < 2.0 and a negative D-dimer results in a PE rate of 1.5 % ( 95 % CI = 0.4 % to 3.7 % ) in the derivation set and 2.7 % ( 95 % CI = 0.3 % to 9.0 % ) in the validation set and only occurred in 29 % of patients . The combination of a score < or = 4.0 by our simple clinical prediction rule and a negative SimpliRED D-Dimer result may safely exclude PE in a large proportion of patients with suspected PE An optimal approach to the diagnosis of deep vein thrombosis ( DVT ) in lower limbs in the emergency department is still unknown . In this prospect i ve cohort study , we aim ed to evaluate the accuracy of the widely available plasma D-dimer test ( VIDAS ) and establish the usefulness of combining D-dimer testing with a clinical model to reduce the need for serial ultra-sonographies and improve the diagnostic strategy of DVT . We performed a cohort study in 383 consecutive out patients referred to the emergency department of Hospital La Princesa , with clinical suspicion of DVT . The patients were stratified into three pre-test probability categories using an explicit clinical model ( Wells score ) , and underwent a quantitative automated ELISA D-dimer assay ( VIDAS D-Dimer bioMérieux ) . Patients were managed according to the diagnostic strategy based on clinical probability and compression ultrasonography ( CU ) . Patients for whom DVT was considered a high pre-test probability with negative ultrasonographic findings in the initial CU , returned the following week for repeat ultrasonography . All patients with DVT excluded did not receive anticoagulant therapy , and were followed up for three months to monitor the development of venous thromboembolic complications . DVT was confirmed in 102 patients ( 26.6 % ) : 95 in the initial test , four in the second test , and three who developed venous thromboembolic complications in the three-month follow-up period . The calculated D-dimer cut-off level was 1 micro g/ml . One hundred patients ( 98 % ) with DVT had positive D-dimer . D-dimer had a sensitivity of 98 % and a negative predictive value of 98.6 % . Among the high-probability patients with positive D-dimer tests and initial negative CU , 9.75 % had DVT on repeat CU at one week . The study results suggest that the addition of VIDAS D-dimer to this diagnostic algorithm could improve the management of patients with suspected DVT in daily practice . A diagnostic approach of DVT based on D-dimer ( cut-off > or = 1 microg/ml ) as the first diagnostic tool for the exclusion of DVT , and the clinical probability model as the tool that identifies those patients requiring a second ultrasonography is useful and suitable for daily medical practice BACKGROUND The st and ard diagnostic approach in patients with suspected deep vein thrombosis is to repeat the compression ultrasonography after 1 week in all patients with an initial normal result . We hypothesized that a normal finding of a D-dimer assay safely obviates the need for repeated ultrasonography . In addition , we evaluated the potential value of a pretest probability assessment for this purpose . METHODS At presentation , consecutive out patients with suspected thrombosis underwent independent assessment by means of ultrasonography of the proximal veins , a whole-blood D-dimer assay , and a pretest clinical model . Patients with normal ultrasonographic findings and an abnormal D-dimer assay result were scheduled for repeated ultrasonography . We evaluated the incidence of symptomatic venous thromboembolic complications during a 3-month follow-up , and the value of clinical pretest probability with ultrasonography or D-dimer assay in scenario analyses . RESULT \n Output:\n " }, { "from": "agent", "value": "The evidence strongly supports the use of clinical prediction rules , particularly the Wells model , for establishing the pretest probability of DVT or pulmonary embolism in a patient before ordering more definitive testing ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Malignant melanoma has been one of the most rapidly increasing cancers within the United States with few modifiable risk factors . This study investigates risk related to dietary factors , which are potentially modifiable . METHODS Newly diagnosed patients with melanoma ( n = 502 ) were recruited from pigment lesion clinics and controls ( n = 565 ) were recruited from outpatient clinics . To investigate the relationship between melanoma and dietary factors in this case-control study , study subjects were requested to complete a food frequency question naire , which assessed diet over the previous year . Using logistic regression , odds ratios ( ORs ) for melanoma were computed for nutrient and alcohol intake . RESULTS Persons in high versus low quintiles of energy-adjusted vitamin D , alpha-carotene , beta-carotene , cryptoxanthin , lutein , and lycopene had significantly reduced risk for melanoma ( ORs < or = 0.67 ) , which remained after adjustment for presence of dysplastic nevi , education , and skin response to repeated sun exposure . Addition of micronutrients from supplements did not add an additional reduction in risk . High alcohol consumption was associated with an increased risk for melanoma , which remained after adjustment for confounders [ OR ( 95 % confidence interval ) in highest versus lowest quintiles , 1.65 ( 1.09 - 2.49 ) ] . CONCLUSIONS Diets consisting of foods rich in vitamin D and carotenoids and low in alcohol may be associated with a reduction in risk for melanoma . These analyses should be repeated in large , prospect i ve studies In a prospect i ve study of 102 patients with pre-neoplasia and /or manifest squamous-cell carcinoma of the lower lip the synchronous occurrence of intra-oral , pharyngeal or laryngeal leukoplakia and carcinoma was assessed . There was a coincidence rate of almost 15 % leukoplakias , including individual carcinomas . This high coincidence is probably due to a combination of various \" risk profiles \" in patients with threatened or manifest lower-lip cancer . Chronic exposure to sunlight , especially in the presence of a genetic disposition , is the most important risk factor in lower-lip cancer and its preceding stages , while chronic alcoholism and smoking abuse have little etiological significance We prospect ively investigated whether alcohol intake and smoking affect the risk of basal cell carcinoma ( BCC ) in subjects from the United States Radiological Technologists ( USRT ) cohort study . We evaluated 68,371 radiological technologists certified during 1926 - 1982 who were free of cancer at the time they answered a first question naire ( 1983 - 1989 ) and who completed a second question naire ( 1994 - 1998 ) . The first question naire provided baseline information on numerous risk factors , including smoking and alcohol intake , and the second provided self-reported cancer diagnoses . During 698,190 person-years of follow-up , we identified 1,360 cases of BCC : 1,036 in women and 324 in men . Cox proportional hazards regression indicated that the trend in BCC was significantly associated with increased alcohol intake ( P for trend = 0.001 ) . Compared with those who reported no alcohol consumption , those who drank < 1 - 2 , 3 - 6 , 7 - 14 , and > 14 drinks/week had multivariate risks of 1.1 [ 95 % confidence interval ( CI ) , 0.9 - 1.3 ] , 1.3 ( 95 % CI , 1.1 - 1.5 ) , 1.4 ( 95 % CI , 1.2 - 1.7 ) , and 1.0 ( 95 % CI , 0.7 - 1.6 ) , respectively . We found no clear association between smoking and BCC . This is the second large prospect i ve study to report a significant but nonmonotonic trend in increased risk associated with alcohol consumption The aim of this study was to identify factors related to lip cancer ( LC ) considering individual characteristics and sociodemographic factors . A case – control study was carried out in the province of Granada ( And alusia , southern Spain ) . The cases were 105 males with squamous-cell carcinoma of the lip , diagnosed between 1987 and 1989 ( aged 20–70 years ) and identified by means of a population -based Cancer Registry . As controls , a r and omised population al sample of 239 males , stratified by age , was used . Multiple logistic regression analysis showed that risk factors are lifetime cumulative tobacco consumption and alcohol consumption . An interaction was found between alcohol consumption and the smoking habit ( leaving the cigarette on the lip ) : OR=23.6 ; 95 % CI : 3.9–142.0 . Other risk factors identified are clear eyes ( OR=3.5 ; CI : 95 % 1.5–8.0 ) , sun exposure early in life and cumulative sun exposure during outdoor work ( OR=11.9 ; 95 % : CI : 1.3–108.9 ) , and skin reaction to sun exposure ( Fitzpatrick levels ) . Another interaction was found between skin reaction and a previous history of common sporadic warts ( OR=4.4 ; 95 % CI : 1.01–19.1 ) . We conclude that LC is related to phenotype , skin reaction to sun exposure , cumulative and early sunlight exposure , and tobacco and alcohol consumption , as well as a low educational level . Leaving the cigarette on the lip is predictive of LC risk irrespective of cumulative tobacco consumption To determine the relationship between 25(OH ) vitamin D levels and non-melanoma skin cancer ( NMSC ) , we performed a nested case – control study in ambulatory , elderly men enrolled in the Osteoporotic Fractures in Men ( MrOS ) Study . Health habit and medical history , including self-reported history of NMSC were recorded and 25(OH)D levels were measured on serum collected at baseline from a r and om sample of Caucasian MrOS subjects . Mean age ( 73 ± 5 ) , BMI , daily vitamin D and calcium intake were similar in the men with ( n = 178 ) and without NMSC ( n = 930 ) , but higher levels of 25(OH)D were associated with a decreased risk of having a history of NMSC ( Ptrend = 0.04 ) . Men in the highest quintile of 25(OH)D ( > 30 ng/mL ) had 47 % lower odds of NMSC ( 95 % CI : 0.30–0.93 , p = 0.026 ) compared to those in the lowest quintile . Our results suggest that a diagnosis of NMSC is not a surrogate for adequate 25(OH)D levels or increased UV exposure , and high 25(OH)D levels may be associated with a reduced risk of NMSC OBJECTIVES This study evaluated the influence of occupational exposure on cancer risk among female Norwegian nurses . METHODS A historical prospect i ve cohort study was performed . The cohort was established from the Norwegian Board of Health 's registry of nurses and included women who graduated from a nursing school before 1985 . The cohort ( N=43 316 ) was linked to the Cancer Registry of Norway . The observed number of cases was compared with the expected number on the basis of national rates . Time since first employment , period of first employment , and duration of employment were used as indicators of exposure . Poisson regression analyses were used for internal comparisons , adjusting for age , period , and fertility . RESULTS The nurses were followed over 1473931 person-years . During the follow-up ( 1953 - 2002 ) , 6193 cancer cases were observed . The st and ardized incidence ratio ( SIR ) for all cancers combined was close to unity . Significantly lower risks were found for cancers with a known association with alcohol and tobacco consumption and sexual activity . A significantly increased risk was found for breast cancer ( SIR 1.14 , 95 % confidence interval ( 95 % CI ) 1.09 - 1.19 ) , ovarian cancer ( SIR 1.14 , 95 % CI 1.04 - 1.25 ) , malignant melanoma ( SIR 1.15 , 95 % CI 1.04 - 1.28 ) , and borderline significant risk appeared for other skin cancer ( SIR 1.12 , 95 % CI 0.98 - 1.29 ) . A positive trend for increasing time since first exposure was found for breast cancer and malignant melanoma . CONCLUSIONS The results indicate an association between working as a nurse and an increased risk of breast cancer and malignant melanoma . Decreased risks , found for several cancers , indicate favorable lifestyle habits among nurses In a prospect i ve study of self-reported demographic , constitutional , and life-style factors in relation to basal cell carcinoma of the skin , we followed a cohort of 73,366 nurses in the United States who were 34 to 59 years of age in 1980 and who had no previous skin or other cancer . In 4 years of follow-up , compared with women living in the Northeast , women residing in California ( age-adjusted relative risk [ RR ] = 1.57 ; 95 % confidence interval [ CI ] = 1.30 to 1.89 ) and Florida ( RR = 2.12 ; 95 % CI = 1.54 to 2.92 ) were more likely to develop basal cell carcinoma . Compared with women having naturally dark brown hair , the age-adjusted relative risk of basal cell carcinoma was increased among women with red ( RR = 2.45 ; 95 % CI = 1.89 to 3.19 ) , blonde ( RR = 1.37 ; 95 % CI = 1.09 to 1.71 ) , or light brown hair ( RR = 1.27 ; 95 % CI = 1.08 to 1.49 ) and was decreased among women with black hair ( RR = 0.66 ; 95 % CI = 0.41 to 1.06 ) . Risk was positively associated in a dose-response manner both with tendency to sunburn as a child or adolescent and with lifetime number of severe and painful sunburns on the face or arms . These risk factors remained significant predictors of disease when included simultaneously in multivariate analyses . Tendency to tan was associated with decreased risk , although this risk was not significant after controlling for the other constitutional determinants and region . Cigarette smoking did not alter the risk of basal cell carcinoma . These prospect i ve data emphasize the importance of sunlight , and skin response to sunlight , as determinants of basal cell carcinoma among women Objective : To investigate the association between total alcohol intake and intake of different types of alcoholic beverages in relation to the risk of basal cell ( BCC ) and squamous cell ( SCC ) carcinoma of the skin . Design : Prospect i ve cohort study . Setting : Follow-up data from a community-based skin cancer study in Australia . Subjects : R and omly selected sample of 1360 adult residents of the township of Nambour who completed a food frequency question naire in 1992 and were monitored for BCC and SCC until 31 December 2002 . Results : No significant association was found between overall BCC or SCC risk and total alcohol intake , or intake of beer , white wine , red wine or sherry and port . However , among those with a prior skin cancer history , there was a significant doubling of risk of SCC for above-median consumption of sherry and port ( multivariable adjusted relative risk 2.46 , 95 % confidence interval 1.06–5.72 ) compared with abstainers . Conclusions : There are no associations between first occurrence of skin cancers and alcoholic beverage consumption . People with a history of skin cancer who consume above-average quantities of sherry or port may be at a raised risk of SCC , although replication of these findings in different study population s is needed to confirm this possible role of specific alcoholic beverages in secondary keratinocytic skin cancer risk We prospect ively examined the intake of alcoholic beverages in relation to the risk of basal cell carcinoma BCC in two large cohorts of men and women . Alcohol intake was assessed with food frequency question naires every 2 - 4 years , and BCC was ascertained by self-report . We used a pooled logistic regression to model the association between alcohol intake and BCC adjusting for various health , sun exposure , and sun-sensitivity factors . During 8 years of follow-up in women ( 1986 - 1994 ) we recorded 3060 cases of BCC , and during 10 years ( 1986 - 1996 ) , we recorded 3028 cases in men . Significant positive associations were observed between total alcohol intake ( P for trend < 0.0001 ) , alcohol from liquor ( P for trend = 0.003 ) , and white wine ( P for trend = 0.01 ) intake and risk of BCC . Compared with those who abstained , those who drank 0.1 - 4.9 g , 5.0 - 14.9 g , 15.0 - 14.9 g , and 30 g or more alcohol a day had multivariate relative risks of 1.11 [ 95 % confidence interval ( CI ) , 1.03 , 1.19 ] , 1.26 ( 95 % CI , 1.12 , 1.41 ) , 1.29 ( 95 % CI , 1.18 , 1.42 ) , and \n Output:\n " }, { "from": "agent", "value": "This study clearly demonstrates that smoking increases the risk of cutaneous squamous cell carcinoma ; however , smoking does not appear to modify the risk of basal cell carcinoma" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: IMPORTANCE Although many patients with end-stage cancer are offered chemotherapy to improve quality of life ( QOL ) , the association between chemotherapy and QOL amid progressive metastatic disease has not been well-studied . American Society for Clinical Oncology guidelines recommend palliative chemotherapy only for solid tumor patients with good performance status . OBJECTIVE To evaluate the association between chemotherapy use and QOL near death ( QOD ) as a function of patients ' performance status . DESIGN , SETTING , AND PARTICIPANTS A multi-institutional , longitudinal cohort study of patients with end-stage cancer recruited between September 2002 and February 2008 . Chemotherapy use ( n = 158 [ 50.6 % ] ) and Eastern Cooperative Oncology Group ( ECOG ) performance status were assessed at baseline ( median = 3.8 months before death ) and patients with progressive metastatic cancer ( N = 312 ) following at least 1 chemotherapy regimen were followed prospect ively until death at 6 outpatient oncology clinics in the United States . MAIN OUTCOMES AND MEASURES Patient QOD was determined using vali date d caregiver ratings of patients ' physical and mental distress in their final week . RESULTS Chemotherapy use was not associated with patient survival controlling for clinical setting and patients ' performance status . Among patients with good ( ECOG score = 1 ) baseline performance status , chemotherapy use compared with nonuse was associated with worse QOD ( odds ratio [ OR ] , 0.35 ; 95 % CI , 0.17 - 0.75 ; P = .01 ) . Baseline chemotherapy use was not associated with QOD among patients with moderate ( ECOG score = 2 ) baseline performance status ( OR , 1.06 ; 95 % CI , 0.51 - 2.21 ; P = .87 ) or poor ( ECOG score = 3 ) baseline performance status ( OR , 1.34 ; 95 % CI , 0.46 - 3.89 ; P = .59 ) . CONCLUSIONS AND RELEVANCE Although palliative chemotherapy is used to improve QOL for patients with end-stage cancer , its use did not improve QOD for patients with moderate or poor performance status and worsened QOD for patients with good performance status . The QOD in patients with end-stage cancer is not improved , and can be harmed , by chemotherapy use near death , even in patients with good performance status A self-control , r and omized , and open-label clinical trial was performed to test the effects of the unicellular green algae Chlorella and hot water extract supplementation on quality of life ( QOL ) in patients with breast cancer . Forty-five female patients with breast cancer who were living at home and not hospitalized were r and omly assigned to 3 groups receiving vitamin mix tablet ( control ) , Chlorella granules ( test food-1 ) , or Chlorella extract drink ( test food-2 ) daily for one month . The Functional Assessment of Cancer Therapy-Breast ( FACT-B ) , the Izumo scale for abdominal symptom-specific QOL , and a narrative-form question naire were used to determine outcomes . Data of thirty-six subjects were included for final analysis . FACT-B scores at presupplementation found no significant group differences in all subscales . Scores on the breast cancer subscale in the Chlorella granule group significantly increased during the supplementation period ( P = 0.042 ) . Fifty percent of the Chlorella extract group reported positive effects by the test food such as reduction of fatigue and improvements of dry skin ( P < 0.01 versus control group ) . The findings suggested the beneficial effects of Chlorella on breast cancer-related QOL and of Chlorella extract on vitality status in breast cancer patients . These findings need to be confirmed in a larger study Ginger supplementation could be an effective adjuvant treatment for chemotherapy-induced nausea ( CIN ) . The aim of this clinical trial was to address significant method ological limitations in previous trials . Patients ( N = 51 ) were r and omly allocated to receive either 1.2 g of st and ardised ginger extract or placebo per day , in addition to st and ard anti-emetic therapy , during the first three cycles of chemotherapy . The primary outcome was CIN-related quality of life ( QoL ) measured with the Functional Living Index- Emesis ( FLIE ) question naire . Secondary outcomes included acute and delayed nausea , vomiting , and retching as well as cancer-related fatigue , nutritional status , and CIN and vomiting-specific prognostic factors . Over three consecutive chemotherapy cycles , nausea was more prevalent than vomiting ( 47 % vs. 12 % ) . In chemotherapy Cycle 1 , intervention participants reported significantly better QoL related to CIN ( p = 0.029 ) , chemotherapy-induced nausea and vomiting (CINV)-related QoL ( p = 0.043 ) , global QoL ( p = 0.015 ) and less fatigue ( p = 0.006 ) than placebo participants . There were no significant results in Cycle 2 . In Cycle 3 , global QoL ( p = 0.040 ) and fatigue ( p = 0.013 ) were significantly better in the intervention group compared to placebo . This trial suggests adjuvant ginger supplementation is associated with better chemotherapy-induced nausea-related quality of life and less cancer-related fatigue , with no difference in adverse effects compared to placebo Purpose Aromatase inhibitor (AI)-induced joint symptoms negatively impact drug adherence and quality of life in breast cancer survivors . Mechanisms underlying symptoms may include inflammation . It is hypothesized that n − 3 polyunsaturated fatty acids ( PUFAs ) have anti-inflammatory properties and may reduce symptoms . Methods We conducted a r and omized , double-blind , placebo-controlled study comparing 4.3 g/day n − 3 PUFA supplements vs placebo for 24 weeks in postmenopausal breast cancer patients starting adjuvant AIs . Primary endpoints were adherence and tolerability ; secondary outcomes included inflammatory cytokines and symptoms assessed by the Brief Pain Inventory short form ( BPI-SF ) and Functional Assessment of Cancer Treatment-Endocrine Symptoms ( FACT-ES ) at 0 , 12 , and 24 weeks . Results Forty-four women were r and omized , of which 35 completed the study . Adherence was ≥ 88 % based on these 35 patients with pill counts as well as change in red blood cell ( RBC ) n − 3 PUFAs . Common toxicities included grade 1 flatulence ( 55 % of both groups ) and belching ( 45 % of n − 3 group ) . Mean pain severity scores ( BPI-SF ) did not change significantly by time or treatment arm . Quality of life , based on FACT-ES scores , significantly decreased within placebo ( p = 0.04 ) , but not the n − 3 group ( p = 0.58 ) , with a trend toward between-group differences ( p = 0.06 ) at 12 weeks , but no significant differences at 24 weeks . RBC n − 3 levels were strongly positively correlated with FACT-ES at 12 weeks , but attenuated at 24 weeks . Conclusion High-dose n − 3 PUFA supplementation is feasible and well tolerated when administered with AIs . Additional studies are needed to evaluate efficacy in prevention of joint symptoms PURPOSE A r and omized phase II study was performed to measure the potential therapeutic effects of yoga on fatigue , erectile dysfunction , urinary incontinence , and overall quality of life ( QOL ) in prostate cancer ( PCa ) patients undergoing external beam radiation therapy ( RT ) . METHODS AND MATERIAL S The participants were r and omized to yoga and no-yoga cohorts ( 1:1 ) . Twice-weekly yoga interventions were offered throughout the 6- to 9-week courses of RT . Comparisons of st and ardized assessment s were performed between the 2 cohorts for the primary endpoint of fatigue and the secondary endpoints of erectile dysfunction , urinary incontinence , and QOL before , during , and after RT . RESULTS From October 2014 to January 2016 , 68 eligible PCa patients underwent informed consent and agreed to participate in the study . Of the 68 patients , 18 withdrew early , mostly because of treatment schedule-related time constraints , result ing in 22 and 28 patients in the yoga and no-yoga groups , respectively . Throughout treatment , those in the yoga arm reported less fatigue than those in the control arm , with global fatigue , effect of fatigue , and severity of fatigue subscales showing statistically significant interactions ( P<.0001 ) . The sexual health scores ( International Index of Erectile Function Question naire ) also displayed a statistically significant interaction ( P=.0333 ) . The International Prostate Symptom Score revealed a statistically significant effect of time ( P<.0001 ) but no significant effect of treatment ( P=.1022 ) . The QOL measures had mixed results , with yoga having a significant time by treatment effect on the emotional , physical , and social scores but not on functional scores . CONCLUSIONS A structured yoga intervention of twice-weekly classes during a course of RT was associated with a significant reduction in pre-existing and RT-related fatigue and urinary and sexual dysfunction in PCa patients OBJECTIVE Although chemotherapy-induced cognitive impairment is common among breast cancer patients , evidence for effective interventions addressing cognitive deficits is limited . This r and omized controlled trial examined the feasibility and preliminary efficacy of a Tibetan Sound Meditation ( TSM ) program to improve cognitive function and quality of life in breast cancer patients . METHODS Forty-seven breast cancer patients ( mean age 56.3 years ) , who were staged I-III at diagnosis , 6 - 60 months post-chemotherapy , and reported cognitive impairment at study entry were recruited . Participants were r and omized to either two weekly TSM sessions for 6 weeks or a wait list control group . Neuropsychological assessment s were completed at baseline and 1 month post-treatment . Self-report measures of cognitive function ( Functional Assessment of Cancer Therapy (FACT)-Cog ) , quality of life ( SF-36 ) , depressive symptoms ( Center for Epidemiologic Studies Depression Scale ) , sleep disturbance ( Pittsburgh Sleep Quality Index ) , fatigue ( Brief Fatigue Inventory ) , and spirituality ( FACT-Sp ) were completed at baseline , the end of treatment , and 1 month later . RESULTS Relative to the control group , women in the TSM group performed better on the verbal memory test ( Rey Auditory Verbal Learning Test trial 1 ) ( p = 0.06 ) and the short-term memory and processing speed task ( Digit Symbol ) ( p = 0.09 ) and reported improved cognitive function ( p = 0.06 ) , cognitive abilities ( p = 0.08 ) , mental health ( p = 0.04 ) , and spirituality ( p = 0.05 ) at the end of treatment but not 1 month later . CONCLUSIONS This r and omized controlled trial revealed that TSM program appears to be a feasible and acceptable intervention and may be associated with short-term improvements in objective and subjective cognitive function as well as mental health and spirituality in breast cancer patients Purpose This study was to evaluate the efficacy of a complementary Chinese treatment modality Guolin-Qigong ( GLQG ) for patients with breast cancer on the body-mind health . Methods A r and omized controlled clinical trial was conducted among 158 women with breast cancer . Subjects were r and omized to receive GLQG ( test group ) versus a physical stretching program ( control group ) following conventional treatment for breast cancer . GLQG and stretching interventions were performed twice a week over 24 weeks . The primary outcome was the change in quality of life ( QoL ) . Secondary outcome measures included anxiety , depression , and clinical indicators . All participants were assessed at four time-points , at the beginning of the study ( T1 ) , after 12 weeks of the intervention ( T2 ) , immediately after 24-week intervention ( T3 ) , and at 48-week follow-up visit ( T4 ) . Results Improvements in QoL were evident in both groups but the test group fared better than the control group at the 12th week ( P < 0.01 ) and particularly in emotional well-being ( P < 0.01 ) and breast cancer-specific well-being ( P < 0.001 ) . The test group showed an improvement in anxiety levels ( P < 0.01 ) , whereas the control group showed improvements in depression ( P < 0.05 ) but there was no significant difference between groups ( P > 0.05 ) . Both groups showed improvements in immunological function and the test group fared better than the control in TNF-α levels ( P < 0.05 ) . The results in subjects who practice d more than 4 times and 6 h per week were similar to that of all subjects ; however , the improvement in anxiety in the GLQG group was more obvious . There are positive correlations between QoL and anxiety and depression . Conclusions Both GLQG and physical stretching are beneficial during recovery following breast cancer . GLQC was more effective in terms of Qol improvements than physical stretching . Both programs brought improvements in anxiety or depression but had were comparable . GLQC group had a greater effect on immunological function than physical exercise BACKGROUND Bojungikki-tang ( Bu-Zhong-Yi-Qi-Tang in Chinese or Hochu-ekki-to in Japanese ) is a widely used herbal prescription in traditional medicine in China , Japan , and Korea . The aim of this study was to investigate the effectiveness of Bojungikki-tang for cancer-related fatigue . METHODS A total of 40 patients with cancer-related fat \n Output:\n " }, { "from": "agent", "value": "As a whole , the results showed clearly superior efficacy of CIM in improving HRQOL .\nFor different domains of HRQOL , different CIM interventions may play different roles .\nIn conclusion , CIM may improve the HRQOL of cancer patients ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias Background Few reports described outcomes of complete compared with infa rct -related artery (IRA)-only revascularisation in patients with ST-elevation myocardial infa rct ion ( STEMI ) and multivessel coronary artery disease ( CAD ) . Moreover , no studies have compared the simultaneous treatment of non-IRA with the IRA treatment followed by an elective procedure for the other lesions ( staged revascularisation ) . Methods The outcomes of 214 consecutive patients with STEMI and multivessel CAD undergoing primary angioplasty were studied . Before the first angioplasty patients were r and omly assigned to three different strategies : culprit vessel angioplasty-only ( COR group ) ; staged revascularisation ( SR group ) and simultaneous treatment of non-IRA ( CR group ) . Results During a mean follow-up of 2.5 years , 42 ( 50.0 % ) patients in the COR group experienced at least one major adverse cardiac event ( MACE ) , 13 ( 20.0 % ) in the SR group and 15 ( 23.1 % ) in the CR group , p<0.001 . Inhospital death , repeat revascularisation and re-hospitalisation occurred more frequently in the COR group ( all p<0.05 ) , whereas there was no significant difference in re-infa rct ion among the three groups . Survival free of MACE was significantly reduced in the COR group but was similar in the CR and SR groups . Conclusions Culprit vessel-only angioplasty was associated with the highest rate of long-term MACE compared with multivessel treatment . Patients scheduled for staged revascularisation experienced a similar rate of MACE to patients undergoing complete simultaneous treatment of non-IRA BACKGROUND As compared with thrombolytic therapy , primary coronary angioplasty results in a higher rate of patency of the infa rct -related coronary artery , lower rates of stroke and reinfa rct ion , and higher in-hospital or 30-day survival rates . However , the comparative long-term efficacy of these two approaches has not been carefully studied . METHODS We r and omly assigned a total of 395 patients with acute myocardial infa rct ion to treatment with angioplasty or intravenous streptokinase . Clinical information was collected for a mean ( + /-SD ) of 5+/-2 years , and medical charges associated with the two treatments were compared . RESULTS A total of 194 patients were assigned to undergo primary angioplasty , and 201 to receive streptokinase . Mortality was 13 percent in the angioplasty group , as compared with 24 percent in the streptokinase group ( relative risk , 0.54 ; 95 percent confidence interval , 0.36 to 0.87 ) . Nonfatal reinfa rct ion occurred in 6 percent and 22 percent of the two groups , respectively ( relative risk , 0.27 ; 95 percent confidence interval , 0.15 to 0.52 ) . The combined incidence of death and nonfatal reinfa rct ion was also lower among patients assigned to angioplasty than among those assigned to streptokinase , with a relative risk of 0.13 ( 95 percent confidence interval , 0.05 to 0.37 ) for early events ( within the first 30 days ) and a relative risk of 0.62 ( 95 percent confidence interval , 0.43 to 0.91 ) for late events ( after 30 days ) . The rates of readmission for heart failure and ischemia were also lower among patients in the angioplasty group than among patients in the streptokinase group . Total medical charges per patient were lower in the angioplasty group ( 16,090 dollars ) than in the streptokinase group ( 16,813 dollars , P=0.05 ) . CONCLUSIONS During five years of follow-up , primary coronary angioplasty for acute myocardial infa rct ion was associated with lower rates of early and late death and nonfatal reinfa rct ion , fewer hospital readmissions for ischemia or heart failure , and lower total medical charges than treatment with intravenous streptokinase BACKGROUND Patients with acute ST-segment elevation myocardial infa rct ion ( STEMI ) and multivessel coronary disease have a worse prognosis compared with individuals with single-vessel disease . We aim ed to study the clinical outcome of patients with STEMI treated with fractional flow reserve (FFR)-guided complete revascularisation versus treatment of the infa rct -related artery only . METHODS We undertook an open-label , r and omised controlled trial at two university hospitals in Denmark . Patients presenting with STEMI who had one or more clinical ly significant coronary stenosis in addition to the lesion in the infa rct -related artery were included . After successful percutaneous coronary intervention ( PCI ) of the infa rct -related artery , patients were r and omly allocated ( in a 1:1 ratio ) either no further invasive treatment or complete FFR-guided revascularisation before discharge . R and omisation was done electronically via a web-based system in permuted blocks of varying size by the clinician who did the primary PCI . All patients received best medical treatment . The primary endpoint was a composite of all-cause mortality , non-fatal reinfa rct ion , and ischaemia-driven revascularization of lesions in non-infa rct -related arteries and was assessed when the last enrolled patient had been followed up for 1 year . Analysis was on an intention-to-treat basis . This trial is registered with Clinical Trials.gov , number NCT01960933 . FINDINGS From March , 2011 , to February , 2014 , we enrolled 627 patients to the trial ; 313 were allocated no further invasive treatment after primary PCI of the infa rct -related artery only and 314 were assigned complete revascularization guided by FFR values . Median follow-up was 27 months ( range 12–44 months ) . Events comprising the primary endpoint were recorded in 68 ( 22 % ) patients who had PCI of the infa rct -related artery only and in 40 ( 13 % ) patients who had complete revascularisation ( hazard ratio 0∙56 , 95 % CI 0∙38–0∙83 ; p=0∙004 ) . INTERPRETATION In patients with STEMI and multivessel disease , complete revascularisation guided by FFR measurements significantly reduces the risk of future events compared with no further invasive intervention after primary PCI . This effect is driven by significantly fewer repeat revascularisations , because all-cause mortality and non-fatal reinfa rct ion did not differ between groups . Thus , to avoid repeat revascularisation , patients can safely have all their lesions treated during the index admission . Future studies should clarify whether complete revascularization should be done acutely during the index procedure or at later time and whether it has an effect on hard endpoints . FUNDING Danish Agency for Science , Technology and Innovation and Danish Council for Strategic Research In the GRADE approach , r and omized trials are classified as high quality evidence and observational studies as low quality evidence but both can be rated down if a body of evidence is associated with a high risk of publication bias . Even when individual studies included in best- evidence summaries have a low risk of bias , publication bias can result in substantial overestimates of effect . Authors should suspect publication bias when available evidence comes from a number of small studies most of which have been commercially funded . A number of approaches based on examination of the pattern of data are available to help assess publication bias . The most popular of these is the funnel plot ; all , however , have substantial limitations . Publication bias is likely frequent , and caution in the face of early results , particularly with small sample size and number of events , is warranted BACKGROUND In acute ST-segment elevation myocardial infa rct ion ( STEMI ) , the use of percutaneous coronary intervention ( PCI ) to treat the artery responsible for the infa rct ( infa rct , or culprit , artery ) improves prognosis . The value of PCI in noninfa rct coronary arteries with major stenoses ( preventive PCI ) is unknown . METHODS From 2008 through 2013 , at five centers in the United Kingdom , we enrolled 465 patients with acute STEMI ( including 3 patients with left bundle-branch block ) who were undergoing infa rct -artery PCI and r and omly assigned them to either preventive PCI ( 234 patients ) or no preventive PCI ( 231 patients ) . Subsequent PCI for angina was recommended only for refractory angina with objective evidence of ischemia . The primary outcome was a composite of death from cardiac causes , nonfatal myocardial infa rct ion , or refractory angina . An intention-to-treat analysis was used . RESULTS By January 2013 , the results were considered conclusive by the data and safety monitoring committee , which recommended that the trial be stopped early . During a mean follow-up of 23 months , the primary outcome occurred in 21 patients assigned to preventive PCI and in 53 patients assigned to no preventive PCI ( infa rct -artery-only PCI ) , which translated into rates of 9 events per 100 patients and 23 per 100 , respectively ( hazard ratio in the preventive-PCI group , 0.35 ; 95 % confidence interval [ CI ] , 0.21 to 0.58 ; P<0.001 ) . Hazard ratios for the three components of the primary outcome were 0.34 ( 95 % CI , 0.11 to 1.08 ) for death from cardiac causes , 0.32 ( 95 % CI , 0.13 to 0.75 ) for nonfatal myocardial infa rct ion , and 0.35 ( 95 % CI , 0.18 to 0.69 ) for refractory angina . CONCLUSIONS In patients with STEMI and multivessel coronary artery disease undergoing infa rct -artery PCI , preventive PCI in noninfa rct coronary arteries with major stenoses significantly reduced the risk of adverse cardiovascular events , as compared with PCI limited to the infa rct artery . ( Funded by Barts and the London Charity ; PRAMI Current Controlled Trials number , IS RCT N73028481 . ) DESIGN : Prospect i ve r and omized , multicentre study . RATIONALE : Recanalisation of the culprit lesion is the main goal of primary angioplasty for acute myocardial infa rct ion . With the exception of cardiogenic shock , staged procedures are performed in the presence of multivessel disease . The study hypothesis is that with modern non-thrombogenic stents ( heparin coated ) complete revascularization with multivessel treatment can be safely achieved during the primary angioplasty procedure with a lower need of subsequent revascularization procedures and at a lower cost . ENDPOINTS : PRIMARY : 12-month incidence of repeat revascularization ( any revascularization , infa rct related artery as well as non-infa rct -related artery ) . SECONDARY : ( 1 ) in hospital repeat revascularization , reinfa rct ion and death ; ( 2 ) total hospital cost ( including a 12 months follow-up period ) . METHODS : 69 patients with ST elevation Acute Myocardial Infa rct ion ( AMI ) , < 12 hours after symptoms onset , undergoing primary angioplasty , with documented multivessel disease and both culprit lesion and 1 to 3 other lesions suitable for stent implantation . Unbalanced r and omization between culprit lesion treatment only ( n = 17 ) and complete multivessel treatment ( n = 52 , with 71 additional lesions treated ) . RESULTS : The two groups were well balanced in terms of clinical characteristics , number of diseased vessels and angiographic characteristics of the culprit lesion . In the complete multivessel treatment group 2.36 ± 0.64 lesions per patient were treated using 2.73 ± 0.78 heparin coated stents ( 1.00 lesions and 1.29 ± 0.61 stents in the culprit treatment group , bothp < 0.001 ) . The duration of the procedure increased from 53 ± 21 min ( culprit treatment group ) to 69 ± 32 min ( p = 0.032 ) and the amount of contrast used from 242 ± 102 ml ( culprit treatment group ) to 341 ± 163 ml ( multivessel complete treatment),p = 0.025 . A similar low incidence of in-hospital major adverse cardiac events was observed in the 2 groups ( 0 and 3.8 % in culprit and \n Output:\n " }, { "from": "agent", "value": "CONCLUSIONS Pooled data provide moderate-certainty evidence that performance of multivessel PCI will provide an appreciable reduction in nonfatal MI and high-certainty evidence that it will reduce need for repeat revascularization .\nPatients are likely to place a high value on these benefits" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVES Prophylactic acetylcysteine along with hydration seems to be better than hydration alone in preventing the reduction in renal function induced by a contrast dye . BACKGROUND Contrast media can lead to acute renal failure that may occasionally require hemodialysis . METHODS One hundred eighty-three consecutive patients with impairment of renal function , undergoing coronary and /or peripheral angiography and /or angioplasty , were r and omly assigned to receive 0.45 % saline intravenously and acetylcysteine ( 600 mg orally twice daily ; group A , n = 92 ) or 0.45 % saline intravenously alone ( group B , n = 91 ) before and after nonionic , low-osmolality contrast dye administration . RESULTS The baseline serum creatinine concentrations were similar ( 1.5 + /- 0.4 mg/dl in group A vs. 1.5 + /- 0.4 mg/dl in group B ; p = 0.37 ) . An increase of > or = 25 % in the baseline creatinine level 48 h after the procedure occurred in 6 ( 6.5 % ) of 92 patients in group A and in 10 ( 11 % ) of 91 patients in group B ( p = 0.22 ) . In the subgroup with a low ( < 140 ml ) contrast dose , renal function deterioration occurred in 5 ( 8.5 % ) of 60 patients in group B and in 0 of 60 patients in group A ( p = 0.02 ; odds ratio [ OR ] 0.44 , 95 % confidence interval [ CI ] 0.35 to 0.54 ) . In the subgroup with a high contrast dose , no difference was found ( 5/31 vs. 6/32 patients , p = 0.78 ) . By multivariate analysis , the amount of contrast agent , but not the treatment strategy , was a predictor of the occurrence of contrast dye-associated nephrotoxicity ( OR 2.58 , 95 % CI 1.1 to 4.9 ; p = 0.035 ) . CONCLUSIONS In patients with reduced renal function undergoing angiography and /or angioplasty , the amount of contrast agent , but not the administration of prophylactic acetylcysteine , was a predictor of renal function deterioration . Prophylactic acetylcysteine might provide better protection than hydration alone , only when a small volume of contrast agent is used The nephroprotective role of N-acetylcysteine ( NAC ) against contrast-induced nephropathy ( CIN ) in patients undergoing peripheral arterial angiography remains unclear . A total of 40 patients undergoing peripheral arterial angiography were r and omized to receive intravenous ( iv ) hydration only ( group 1 ) or oral NAC in addition to iv hydration ( group 2 ; IS RCT N : 35882618 ) . Primary outcome was reduction in the elevation of urinary retinol binding protein ( RBP ) , albumin — creatinine ratio ( ACR ) , and serum creatinine ( serC ) . Groups 1 and 2 had equivocal percentage reduction in RBP and ACR levels from baseline ( P = .80 and .30 ) . A significant reduction in serC was , however , observed with NAC by third postprocedure day ( P = .04 ) . One patient in the treatment arm developed CIN compared with 3 patients in the control group ( P = .33 ) . Equivocal changes in RBP and ACR levels by both treatments seem to indicate that either is equally effective in affording renal protection Purpose To determine the role of prophylactic N-acetylcysteine in the prevention of contrast-induced nephrotoxicity . Methods One hundred and sixteen patients undergoing noncoronary angiography , with or without pre-existing renal impairment , were r and omly assigned to receive prophylactic oral N-acetylcysteine or no treatment . Serum creatinine ( sCr ) was measured prior to angiography and 48 hr after the procedure . Urine sample s were collected before and after the examination for measurement of malondialdehyde ( MDA ) concentration . Contrast-induced nephrotoxicity ( CIN ) was defined as a rise in serum creatinine of 0.5 mg/dl ( 44 mmol/l ) at 48 hr . Results Complete data were available on 106 patients , 53 of whom had received N-acetylcysteine . There were no significant differences between the two groups in baseline characteristics , type of angiogram , or volume and concentration of contrast used . Three patients ( 2.8 % ) , all of whom had received N-acetylcysteine , developed CIN . In the N-acetylcysteine group , the mean serum creatinine in patients with renal impairment was 151.0 ± 44.2 μmol/l prior to the procedure and 155.6 ± 48.6 μmol/l ( p = 0.49 ) after the procedure . Respective values for those without renal impairment were 79.6 ± 15.1 μmol/l and 81.2 ± 20.0 μmol/l ( p = 0.65 ) . In the group that had not received N-acetylcysteine , the mean serum creatinine levels before and after the procedure were 150.0 ± 58.1 and 141.4 ± 48.0 μmol/l ( p = 0.17 ) in patients with renal impairment and 79.7 ± 14.2 and 81.4 ± 15.4 μmol/l ( p = 0.34 ) in those without renal impairment . In both groups , no significant change in urinary MDA concentration was observed . Conclusion There is no benefit to the prophylactic administration of N-acetylcysteine in patients undergoing peripheral angiography using current contrast media BACKGROUND Radiographic contrast agents can cause a reduction in renal function that may be due to reactive oxygen species . Whether the reduction can be prevented by the administration of antioxidants is unknown . METHODS We prospect ively studied 83 patients with chronic renal insufficiency ( mean [ + /-SD ] serum creatinine concentration , 2.4+/-1.3 mg per deciliter [ 216+/-116 micromol per liter ] ) who were undergoing computed tomography with a nonionic , low-osmolality contrast agent . Patients were r and omly assigned either to receive the antioxidant acetylcysteine ( 600 mg orally twice daily ) and 0.45 percent saline intravenously , before and after administration of the contrast agent , or to receive placebo and saline . RESULTS Ten of the 83 patients ( 12 percent ) had an increase of at least 0.5 mg per deciliter ( 44 micromol per liter ) in the serum creatinine concentration 48 hours after administration of the contrast agent : 1 of the 41 patients in the acetylcysteine group ( 2 percent ) and 9 of the 42 patients in the control group ( 21 percent ; P=0.01 ; relative risk , 0.1 ; 95 percent confidence interval , 0.02 to 0.9 ) . In the acetylcysteine group , the mean serum creatinine concentration decreased significantly ( P<0.001 ) , from 2.5+/-1.3 to 2.1+/-1.3 mg per deciliter ( 220+/-118 to 186+/-112 micromol per liter ) 48 hours after the administration of the contrast medium , whereas in the control group , the mean serum creatinine concentration increased nonsignificantly ( P=0.18 ) , from 2.4+/-1.3 to 2.6+/-1.5 mg per deciliter ( 212+/-114 to 226+/-133 micromol per liter ) ( P<0.001 for the comparison between groups ) . CONCLUSIONS Prophylactic oral administration of the antioxidant acetylcysteine , along with hydration , prevents the reduction in renal function induced by contrast agents in patients with chronic renal insufficiency Despite myriad improvements in the care of hospitalized patients , a decline in renal function remains a common event . Renal function in 4,622 consecutive patients admitted to the medical and surgical services of an urban tertiary care hospital was followed up prospect ively from the time of admission . Some degree of renal insufficiency developed in 7.2 % of patients . Decreased renal perfusion , medications , surgery , and radiographic contrast media were the most common causes of hospital-acquired renal insufficiency ( HARI ) . The overall mortality rate was 19.4 % and was similar among patients for all causes of renal insufficiency , except sepsis . For patients with a greater than 3.0-mg/dL increase in serum creatinine level , the mortality rate was 37.8 % . As shown by previous investigators , age and preexisting renal insufficiency were risk factors for HARI . Women and blacks had less hospital-acquired renal failure . The increasing acuity of hospital admissions has been accompanied by a greater incidence of acute renal insufficiency in patients admitted to hospitals . There is a trend toward better survival in patients with a severe deterioration in renal function AIMS Prophylactic administration of N-acetylcysteine ( NAC ) ( 600 mg orally twice daily ) , along with hydration , prevents contrast agent-associated nephrotoxicity ( CAN ) induced by a low dose of non-ionic , low-osmolality contrast dye . We tested whether a double dose of NAC is more effective to prevent CAN . METHODS AND RESULTS Two-hundred-twenty-four consecutive patients with chronic renal insufficiency ( creatinine level > or = 1.5mg/dl and /or creatinine clearance < 60ml/min ) , referred to our institution for coronary and /or peripheral procedures , were r and omly assigned to receive 0.45 % saline intravenously and NAC at the st and ard dose ( 600 mg orally twice daily ; SD Group ; n=110 ) or at a double dose ( 1200 mg orally twice daily ; DD Group ; n=114 ) before and after a non-ionic , low-osmolality contrast dye administration . Increase of at least 0.5mg/dl of the creatinine concentration 48h after the procedure occurred in 12/109 patients ( 11 % ) in the SD Group and 4/114 patients ( 3.5 % ) in the DD Group ( P=0.038 ; OR=0.29 ; 95 % CI=0.09 - 0.94 ) . In the subgroup with low ( < 140ml , or contrast ratio < = 1 ) contrast dose , no significant difference in renal function deterioration occurred between the 2 groups . In the subgroup with high ( > or = 140ml , or contrast ratio > 1 ) contrast dose , the event was significantly more frequent in the SD Group . Conclusions Double dose of NAC seems to be more effective than the st and ard dose in preventing CAN , especially with high volumes of non-ionic , low-osmolality contrast agent OBJECTIVE ( S ) Apart from proper hydration , only oral N-acetylcysteine ( NAC ) has shown efficacy in reducing radiographic contrast media (RCM)-induced acute renal failure , though its benefit has been challenged . We investigated the effect of intravenous ( i.v . ) NAC on renal function in patients with vascular disease receiving RCM for angiography . METHODS Single-center , r and omized , double-blind , placebo-controlled trial . Based on a previous study , a trial with 44 patients each in placebo and treatment arms would give at least 80 % power to show a statistically significant difference at the 5 % level . Vascular patients undergoing angiography were consented and segregated into those whose serum creatinine ( SC ) level was normal or raised ( men > 1.32 mg/dl ; women > 1.07 mg/dL ) . All patients received 500 mL i.v . normal saline 6 to 12 hours prior to and then after angiography . Groups with normal SC and raised SC were r and omly assigned to either 1 g of NAC with normal saline before and after angiography or nothing ( placebo ) . Main outcome measures were change in SC and creatinine clearance ( CrCl ) as measured 1 , 2 , and 7 days postangiography ( with comparison between active and placebo groups using unpaired t test ) and incidence of acute renal decline ( > 25 % or 0.5 mg/dL rise in SC ) at 48 hours ( with comparison between active and placebo using the Fisher exact test ) . RESULTS Forty-six patients received NAC ( 29 normal SC , 17 raised SC ) , and 48 received placebo ( 27 normal SC , 21 raised SC ) . There was no significant difference in postangiography SC or CrCl at any of the time points measured between NAC and placebo in patients with either normal or raised SC . In the raised SC group , 3 patients from both the NAC and placebo groups suffered acute renal declines . Importantly , at 48 hours , the impaired SC group had a significant reduction in CrCl ( -14 % + /- 41 % vs + 18 % + /- 58 % : P = .0142 ) and a significant rise in SC ( + \n Output:\n " }, { "from": "agent", "value": "In conclusion , insufficient evidence exists to recommend NAC for the prevention of CIN in patients undergoing peripheral angiography" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background : Although patients with cancer are often accompanied by a relative during breaking bad news ( BBN ) consultations , little is known regarding the efficacy of training programmes design ed to teach residents the communication skills needed to break bad news in a triadic consultation . Methods : Residents were r and omly assigned to a 40-h dyadic and triadic communication skills training programme ( n=48 ) or a waiting list ( n=47 ) . A simulated BBN triadic consultation was audiotaped at baseline , and after training for the training group , and 8 months after baseline for the waiting list group . Transcripts were analysed using content analysis software ( LaComm ) . A coder determined the moment of bad news delivery and the relative ’s first turn of speech regarding the bad news . A generalised estimating equation was used to evaluate residents ’ communication skills , BBN timing , and the relative ’s inclusion in the consultation . Results : Ninety-five residents were included . After training , the duration of the pre-delivery phase was found to be longer for the trained residents ( relative risk (RR)=3.04 ; P<0.001 ) . The simulated relative ’s first turn of speech about the bad news came more often during the pre-delivery phase ( RR=6.68 ; P=0.008 ) , and was more often initiated by the trained residents ( RR=19.17 ; P<0.001 ) . Trained residents also used more assessment ( RR=1.83 ; P<0.001 ) and supportive utterances ( RR=1.58 ; P<0.001 ) . Conclusion : This study demonstrates that a training programme that focuses on the practice of dyadic and triadic communication skills can improve the communication skills of the participating residents in a BBN triadic consultation . Such a training should be included in resident curriculum Abstract Objective : Although communication skills represent an increasingly important aspect of medical care , little has been done to assess the best method of teaching these skills . Our study was design ed to assess simulation-debriefing compared to lecture in teaching skills for Breaking Bad News ( BBN ) in obstetrics . Methods : This is a r and omized prospect i ve trial of house staff from a large academic medical center . Subjects initially underwent baseline simulation , followed by evaluation on BBN skills by themselves , a faculty observer , and the st and ardized patient ( SP ) . The subjects were then immediately r and omized to a debriefing session by faculty or to a lecture about BBN . Subsequently , both groups underwent a second simulation with the same three assessment s , yielding post-intervention data . Results : 35 subjects completed both simulations . Both debriefing and lecture curricula showed improvement in scores by self ( p = 0.010 ) and faculty ( p < 0.001 ) . The debriefing group improved significantly more than the lecture group for self-evaluation ; additionally , improvements were greater for the debrief group in verbal and nonverbal skills . Long-term follow-up three months after both interventions demonstrated continued improvement in BBN . Conclusions : Simulation training with debriefing is effective for teaching communication skills , and superior to lecture for self-perceived improvement . Long-term follow-up suggested retention of confidence in BBN skills Background : Physician-patient communication skills help determine the nature and quality of diagnostic information elicited from patients , the quality of the physician 's counseling , and the patient 's adherence to treatment . In spite of their importance , surveys have demonstrated a wide variability and deficiencies in the teaching of these skills . Aim : Describe two specific method ologies for teaching physician-patient communication skills developed at our institution and pilot test them for effectiveness . Methods : Between 2004 and 2009 we developed “ doc.com , ” a series of 41 media-rich online modules on all aspects of healthcare communication jointly with the American Academy on Communication in Healthcare . Starting in 2006 , we exp and ed our pre-existing experience with the videoconferencing system “ WebOSCE ” into the online application “ WebEncounter . ” This new methodology combines practice of communication skills on st and ardized patients with structured assessment and constructive feedback . We had three r and omized groups : controls who did only the assessment parts of a WebOSCE on two occasions , a doc.com group who had doc.com in between the assessment occasions , and a combined group that had both doc.com and a WebEncounter between assessment s. Results / Conclusion : We found significant improvement in skills as components were added , and the training program was well received BACKGROUND Previous end-of-life and palliative care curricula for surgical residents have shown improved learner confidence , but have not measured cognitive knowledge or skill acquisition . METHODS A nonr and omized trial evaluated a structured palliative care curriculum for 7 postgraduate year 2 surgical residents ( intervention group ) compared with 6 postgraduate year 5 surgical residents ( comparison group ) . Outcomes were measured using an 18-item knowledge test , a 20-minute objective structured clinical examination simulating an intensive care unit family conference , and a survey measuring self-confidence . RESULTS The mean knowledge test scores for the intervention group , both before and after undergoing the structured palliative care curriculum , were no different from the comparison group . There was also no difference in objective structured clinical examination scores between the 2 groups . The intervention group felt less comfortable managing pain , breaking bad news , or addressing ethical issues . CONCLUSIONS Junior surgical residents have similar palliative care knowledge to senior residents without a palliative care curriculum . After participating in a palliative care curriculum , they have simulated skills that are similar to chief residents . However , self-confidence is lower among junior residents despite undergoing a palliative care curriculum Intensive care medical and nursing staff self-rate their communication skills as improved following attendance at the European Donor Hospital Education Programme ( EDHEP ) workshop . A prospect i ve study was conducted to determine what impact EDHEP has on communication skills . Doctor-nurse pairs from 10 experimental and 10 control Intensive Care Units undertook two st and ardized simulated relative encounters ( Breaking Bad News and Donation Request ) at three measurement points ( pre , post and follow-up ) . Nurses showed no change in communication skills . Experimental group doctors showed significant improvement in breaking bad news and requesting donation ; most of these improvements were not maintained . Control group doctors showed some improvement in breaking bad news , indicating that participating in measurement by itself initiates some transient change in communication skills . Attendance at EDHEP does lead to significant improvement in some , but not all , communication skills essential in breaking bad news and requesting donation . Further research is necessary to determine what factors additional to EDHEP will contribute to enduring change in these particular skills BACKGROUND Internal medicine residents are largely unprepared to carry out end-of-life ( EOL ) conversations . There is evidence that these skills can be taught , but data from r and omized controlled trials are lacking . PURPOSE We studied whether a day-long communication skills training retreat would lead to enhanced performance of and confidence with specific EOL conversations . We also studied the effect of the retreat on residents ' ability to respond to patient emotions . METHODS PGY-2 resident volunteers were r and omly assigned to a retreat group or a control group . The retreat involved a combination of teaching styles and skills practice with st and ardized patients . All participants completed question naires and were evaluated carrying out two types of conversations ( breaking bad news or discussing direction of care ) with a st and ardized patient before ( T1 ) and after ( T2 ) the intervention phase . Conversations were audio-taped and later rated by a research er blinded to group assignment and time of assessment . RESULTS Forty-nine residents agreed to r and omization ( 88 % ) with 23 residents r and omized to the retreat group and 26 to the control group . Compared to controls , retreat participants demonstrated higher T2 scores for breaking bad news , discussing direction of care , and responding to emotion . Comparing T2 to T1 , the retreat group 's improvement in responding to emotion was statistically significant . The retreat group 's confidence improved significantly only for the breaking bad news construct . CONCLUSIONS A short course for residents can significantly improve specific elements of resident EOL conversation performance , including the ability to respond to emotional cues OBJECTIVE Breaking bad news ( BBN ) is a complex task which involves dealing cognitively with different relevant dimensions and a challenging task which involves dealing with intense emotional contents . No study however has yet assessed in a r and omized controlled trial design the effect of a communication skills training on residents ' physiological arousal during a BBN task . METHODS Residents ' physiological arousal was measured , in a r and omized controlled trial design , by heart rate and salivary cortisol before , during and after a BBN simulated task . RESULTS Ninety-eight residents were included . MANOVA showed significant group-by-time effects . Trained residents ' mean heart rate levels remained elevated after training and cortisol areas under the curve increased after training compared to untrained residents . CONCLUSION Communication skills training has an effect on residents ' physiological arousal . Residents ' self-efficacy and communication skills improvements in a BBN simulated task are associated with an elevated physiological arousal , which becomes proportional to the complexity of the task and reflects a better engagement and performance . PRACTICE IMPLICATION S Residents should be informed that , to perform a task , they need to engage in the task with a physiological arousal proportional to the complexity of this task . Communication skills training should be adapted Purpose High- quality palliative care requires physicians who communicate effectively , yet many do not receive adequate training . Leading efforts to demonstrate the effectiveness of such training have involved time-intensive programs that included primarily attending physicians , which have been conducted outside of the United States . The goal was to evaluate the effect of a short course to improve residents ' communication skills delivering bad news and eliciting patients ' preferences for end-of-life care . Method This prospect i ve trial enrolled internal medicine residents at Duke University Medical Center from 1999 to 2001 . The course consisted of small-group teaching with lecture , discussion , and role-play . The outcome measure was observed communication skills delivering bad news and eliciting patients ' preferences for end-of-life treatment , assessed via audio-recorded st and ardized patient encounters before and after receiving the intervention . Results Thirty-seven residents received the intervention and 19 were in the control group . Residents attending the course demonstrated statistically significant increases in their overall skill ratings in the delivery of bad news , with improvement in the specific areas of information giving and responding to emotional cues . Although cumulative scores for discussion s about patient preferences for treatment did not increase , residents demonstrated enhanced specific skills including discussing probability , presenting clinical scenarios , and asking about prior experience with end-of-life decision making . Conclusion A relatively short , intensive course can improve the end-of-life communication skills of U.S. medical residents BACKGROUND Physicians typically learn to communicate bad news to patients through trial and error or observation of more senior physicians . To give medical students initial instruction and experience in this area , we developed two st and ardized patient instructor ( SPI ) experiences in \" breaking bad news . \" METHODS Twenty-one junior medical students had an SPI experience discussing a new diagnosis of rectal cancer or pregnancy loss . These 21 students , and 17 students having neither experience , interviewed the pregnancy loss SPI on the clinical performance examination ( CPE ) at the end of the junior year . RESULTS Students who had previously had a \" breaking bad news \" SPI experience performed significantly better on the CPE pregnancy loss station than students without this experience . There was no significant difference in performance between students who had previously had the pregnancy loss versus rectal cancer SPI . CONCLUSIONS This research provides evidence for the effectiveness of bad news communication skills teaching , and its potential for transfer across content areas PURPOSE The aim of this study was to identify the effects of a communication skills training ( CST ) program for oncologists , developed based on patient preferences regarding oncologists ' communication . PARTICIPANTS AND METHODS Thirty oncologists were r and omly assigned to either an intervention group ( IG ; 2-day CST workshop ) or control group ( CG ) . Participants were assessed on their communication performance during simulated consultation and their confidence in communicating with patients at baseline and follow-up . A total of 1,192 patients ( response rate , 84.6 % ) who had consultations with the participating oncologists at baseline and /or follow-up were assessed regarding their distress using the Hospital Anxiety and Depression Scale , satisfaction with the consultation , and trust in their oncologist after the consultation . RESULTS At the follow-up survey , the performance scores of the IG had improved significantly , in terms of their emotional support ( P = .011 ) , setting up a supportive environment ( P = .002 ) , and ability to deliver information ( P = .001 ) , compared with those of the CG . Oncologists in the IG were rated higher at follow-up than those in the CG in terms of their confidence in themselves ( P = .001 ) . Patients who met with oncologists after they had undergone the CST were significantly less depressed than those who met with oncologists in the CG ( P = .027 ) . However , the CST program did not affect patient satisfaction with oncologists ' style of communication . CONCLUSION A CST program based on patient preferences is effective for both oncologists and patients with cancer . Oncologists should consider CST as an approach to enhancing their communication skills OBJECTIVE We have previously described a breaking bad news ( BBN ) training program for primary care physicians [ Ungar L , Alperin M , Amiel GE , Beharier Z , Reis S. Breaking bad news : structured training for family medicine residents . Patient Educ Couns 2002;48:63 - 68 ] . In this paper , we present the assessment of an educational intervention aim ed at improving this important skill . METHODS The assessment tool was an eight station objective structured clinical examination ( OSCE ) utilizing st and ardized patients ( SPs ) . Intervention and control groups of 17 general practitioners ( GP ) each were evaluated before and after an educational intervention , or a Balint group ( control ) . RESULTS Intervention group GPs significantly increased their average grade on the post-test as compared to the pre-test ( 58.5 \n Output:\n " }, { "from": "agent", "value": "Conclusions Interventions are effective for improving news delivery and physician confidence ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND The clinical oral examination ( COE ) is the criterion st and ard for the initial detection of oral lesions that harbor dysplasia or oral squamous cell carcinoma ( OSCC ) at an early stage when they are most treatable . The authors conducted a systematic review to assess the effectiveness of the COE in predicting histologic diagnosis of dysplasia or OSCC . METHODS The authors conducted automated search es of PubMed , Web of Knowledge , and the Cochrane Library from 1966 through 2010 for r and omized controlled trials and observational studies that included the terms \" oral mucosal lesion screening \" and \" oral lesions . \" They determined the quality ( sensitivity , specificity , positive predictive value , negative predictive value and diagnostic odds ratio ) of selected studies by using the Quality Assessment of Diagnostic Accuracy Studies tool . RESULTS The overall diagnostic odds ratio was 6.1 ( 95 % confidence interval , 2.1 - 17.6 ) ; therefore , the COE was considered to have poor overall performance as a diagnostic method for predicting dysplasia and OSCC . CLINICAL IMPLICATION S On the basis of the available literature , the authors determined that a COE of mucosal lesions generally is not predictive of histologic diagnosis . The fact that OSCCs often are diagnosed at an advanced stage of disease indicates the need for improving the COE and for developing adjuncts to help detect and diagnose oral mucosal lesions BACKGROUND The aim of this prospect i ve study was to evaluate the efficacy of a new form of autofluorescence imaging and tissue reflectance spectroscopy ( Identafi , DentalEZ ) in examining patients with oral mucosal lesions . METHODS The authors examined 88 patients with 231 oral mucosal lesions by conventional oral examination ( COE ) using white-light illumination and ×2.5 magnification loupes , followed by examination using Identafi . The authors noted fluorescence visualization loss , the presence of blanching , and diffuseness of vasculature . They performed incisional biopsies to provide definitive histopathologic diagnosis . RESULTS Identafi 's white light produced lesion visibility and border distinctness equivalent to COE . Identafi 's violet light displayed a sensitivity of 12.5 % and specificity of 85.4 % for detection of oral epithelial dysplasia ( OED ) . The authors noted visible vasculature using the green-amber light in 40.9 % of lesions . CONCLUSIONS Identafi 's intraoral white light provided detailed visualization of oral mucosal lesions comparable with examination using an extraoral white-light source with magnification . A high level of clinical experience is required to interpret the results of autofluorescence examination as the violet light displayed low sensitivity for detection of OED . The green-amber light provided additional clinical information in relation to underlying vasculature and inflammation of lesions . PRACTICAL IMPLICATION S Examination using Identafi can provide clinicians with more clinical data than a st and ard COE with yellow inc and escent light , but the clinical and optical findings should be interpreted as a whole and not in isolation . Clinicians should use the light features of Identafi in a sequential and differential manner The prognosis for patients with oral squamous cell carcinoma remains poor despite advances in multimodal treatment concepts . Early diagnosis and treatment is the key to improved patient survival . A device ( VELscope ) that uses autofluorescence technology , allowing direct fluorescence visualization of the oral cavity , might be a useful tool for oral cancer detection or as an adjunct to st and ard clinical examination . A total of 289 patients with oral premalignant lesions were r and omly divided into two groups for clinical examination of precancerous oral lesions . In group 1 , 166 patients were examined conventionally with white light , and in group 2 , 123 patients were examined with the autofluorescence visualization device ( VELscope ) in addition to the white light examination . Biopsies were obtained from all suspicious areas identified in both examination groups ( n=52 ) . In the first step , baseline characteristics of the two groups ( only white light vs. white light and VELscope ) were compared to exclude selection bias . In the second step , for the group examined with white light and VELscope ( 123 patients ) , the diagnostic strategies were compared with regard to sensitivity and specificity using biopsy as the gold st and ard . The results showed that using the VELscope leads to higher sensitivity ( 100 % instead of 17 % ) , but to lower specificity ( 74 % instead of 97 % ) . Thus , we can conclude that the VELscope is a useful new diagnostic device for detection of oral cancer diseases The survival of patients with oral cancer is decreased by locoregional recurrence after an initial multimodal treatment . In order to identify lesions in the oral cavity for a possible recurrence , clinical evaluation as well as MRI or CT scanning is advised . The evaluation of mucosa lesions is hampered by changes related to radio- and chemotherapy as well as reconstruction with tissue flaps . Several techniques for easier identification of tissue abnormalities in the oral cavity have been advocated as adjuncts in order to facilitate identification . Especially methods using altered tissue fluorescence have gained much interest during the last decade . The aim of our prospect i ve study was to evaluate fluorescence properties of undiagnosed mucosa lesions with the VELscope device in patients with multimodal treated oral cancer prior to histological confirmation . In total , 41 patients with a history of oral squamous cell carcinomas ( OSCC ) ( 19 females and 22 males ) with undiagnosed mucosa lesions where included in the study . After clinical evaluation , examination and documentation using the VELscope ® device were performed . Then , an incisional biopsy was performed . An autofluorescence loss indicating a malignant or dysplastic mucosa condition could be detected in six patients ( 14.6 % ) ; however , only one OSCC and one SIN revealed a complete autofluorescence loss . In four patients , OSCC was present in lesions with retained autofluorescence . Sensitivity and specificity for the VELscope ® examination to identify malignant oral lesions by autofluorescence were 33.3 and 88.6 % , respectively . The positive and negative predictive values were 33.3 and 88.6 % , respectively . No statistical correlation between gender and lesion appearance versus autofluorescence loss could be detected . In contrast to mucosa lesions in patients with no prior treatment , the autofluorescence evaluation with the VELscope reveals no additional information in our analysis . Accordingly , invasive biopsies as gold st and ard are still needed to get sufficient evidence regarding potential malignancy in patients after multimodal treatment for oral cancer BACKGROUND An expert panel convened by the American Dental Association ( ADA ) Council on Scientific Affairs and the Center for Evidence -Based Dentistry conducted a systematic review and formulated clinical recommendations to inform primary care clinicians about the potential use of adjuncts as triage tools for the evaluation of lesions , including potentially malignant disorders ( PMDs ) , in the oral cavity . TYPES OF STUDIES REVIEW ED This is an up date of the ADA 's 2010 recommendations on the early diagnosis of PMDs and oral squamous cell carcinoma . The authors conducted a systematic search of the literature in MEDLINE and Embase via Ovid and the Cochrane Central Register of Controlled Trials to identify r and omized controlled trials and diagnostic test accuracy studies . The authors used the Grading of Recommendations Assessment , Development and Evaluation approach to assess the certainty in the evidence and to move from the evidence to the decisions . RESULTS The panel formulated 1 good practice statement and 6 clinical recommendations that concluded that no available adjuncts demonstrated sufficient diagnostic test accuracy to support their routine use as triage tools during the evaluation of lesions in the oral cavity . For patients seeking care for suspicious lesions , immediate performance of a biopsy or referral to a specialist remains the single most important recommendation for clinical practice . In exceptional cases , when patients decline a biopsy or live in rural areas with limited access to care , the panel suggested that cytologic testing may be used to initiate the diagnostic process until a biopsy can be performed ( conditional recommendation , low- quality evidence ) . CONCLUSIONS AND PRACTICAL IMPLICATION S The authors urge clinicians to remain alert and take diligent action when they identify a PMD . The authors emphasize the need for counseling because patients may delay diagnosis because of anxiety and denial OBJECTIVE AND STUDY DESIGN Several noninvasive adjunctive methods have been proposed for identification of potentially malignant mucosa lesions . The VELscope is an optical device for detecting spatial changes in mucosa autofluorescence caused by premalignant lesions in conjunction with an intraoral exam . The aim of our prospect i ve study was to correlate loss of autofluorescence from undiagnosed mucosa lesions with histology . RESULTS In total 64 patients considered at risk for squamous cell carcinoma ( 20 had previous OSCC ) were included in the study . Regions with fluorescence visualization loss were considered as malignant or dysplastic . All patients underwent biopsy after VELscope examination . In 22 patients ( 34.4 % ) a loss of autofluorescence indicating a squamous intraepithelial neoplasia ( SIN ) or malignant mucosal lesion was detected . The sensitivity of identification of malignant and dysplastic areas with the VELscope was 100 % and the specificity was 80.8 % , respectively , compared with histology as gold st and ard . The positive predictive value was 54.5 % and the negative predictive value was 100 % respectively . CONCLUSION Evaluation of autofluorescence imaging with VELscope can assist in the identification of malignant and potentially malignant oral lesions from normal mucosa in high-risk patients but does not help discriminating benign lesions from malignant or premalignant mucosal conditions BACKGROUND To analyze the efficacy of fluorescence visualization in early detection of oral early neoplastic processes when used by an inexperienced and an adept oral examiner . METHODS A dental student and an expert professional in oral diagnosis examined 15 r and omly selected patients using conventional oral examination and fluorescence visualization search ing for early signs of epithelial dysplasia and oral potentially malignant disorders . Patients detected with oral lesions in any of examinations were su bmi tted to incisional biopsy for definitive diagnosis . RESULTS Taking histopathologic analysis as Gold St and ard , sensitivity , specificity , positive and negative predictive values and accuracy of inexperienced examiner for detecting both epithelium dysplasia and oral potentially malignant disorders increased when using fluorescence visualization compared to conventional white light examination , matching the same values found for expert professional in oral diagnosis . Furthermore , it was possible to observe discrete increase in the efficacy of expert professional 's examination when using fluorescence visualization . CONCLUSION This study indicates fluorescence visualization is capable of improve inexperienced professionals ' efficacy for early detecting oral lesions more prone to be dysplastic and oral potentially malignant disorders Objective . Although approved by the US Food and Drug Administration for clinical use , the utility of h and held tissue reflectance and autofluorescence devices for screening head and neck cancer patients is poorly defined . There is limited published evidence regarding the efficacy of these devices . The authors investigated the sensitivity and specificity of these modalities compared with st and ard examination . Study Design . Prospect i ve , cross-sectional analysis . Setting . Tertiary care medical center . Subjects and Methods . Patients who were treated previously for head and neck cancer ( n = 88 ) between 2009 and 2010 were included . Patients were screened using white light visualization ( st and ard of care ) and compared with tissue reflectance and autofluorescence visualization . Screening results were compared with biopsy or long-term follow-up . Results . Autofluorescence visualization had a specificity of 81 % and a sensitivity of 50 % for detecting oral cavity cancer , whereas white light visualization had a specificity of 98 % and a sensitivity of 50 % . Tissue reflectance visualization had low sensitivity ( 0 % ) and good specificity ( 86 % ) . The power of this study was insufficient to compare the positive and negative predictive values of st and ard white light examination ( 50 % and 98 % , respectively ) to tissue autofluorescence ( 11 % and 97 % ) or reflectance ( 0 % and 95 % ) . In addition , stratification by previous radiation therapy found no statistically significant difference in screening results . Conclusion . St and ard clinical lighting has a higher specificity than tissue reflectance and autofluorescence visualization for detection of disease in patients with a history of head and neck cancer . This study does not support the added costs associated with these devices OBJECTIVE To determine the usefulness of the VELscope in detecting malignant and premalignant oral cavity lesions . STUDY DESIGN Prospect i ve clinical study . SETTING Head and neck oncology clinic at an academic tertiary care centre . SUBJECTS AND METHODS Eighty-five patients with a history of smoking , alcohol use , and /or head and neck cancer were recruited into the study . The VELscope was used to examine patients ' oral cavities after a clinical examination . Biopsies were then taken from suspicious areas . RESULTS Of the 85 patients included in the study , 33 underwent biopsies prompted by a clinical examination , the VELscope \n Output:\n " }, { "from": "agent", "value": "Optical fluorescence imaging demonstrated positive results , with higher sensitivity scores , increased lesion detection and visualisation than comprehensive oral examination alone in the clinical evaluation of oral squamous cell carcinoma and oral potentially malignant disorders ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND It is generally accepted that smoking increases blood pressure and inhibits muscle sympathetic nerve activity ( SNA ) . The decrease in muscle SNA with cigarette smoking might be secondary to baroreflex responses to the pressor effect of smoking , thus obscuring a sympathetic excitatory effect of smoking . We tested the hypothesis that smoking increases sympathetic outflow . METHODS AND RESULTS We examined the effects of sham smoking , cigarette smoking , and cigarette smoking in combination with nitroprusside on muscle ( baroreflex-dependent ) SNA in 10 healthy habitual smokers . The 3 sessions were performed in r and om order , each study on a separate day . In an additional study , we also investigated the effects of sham smoking and cigarette smoking on skin ( baroreflex-independent ) SNA in 9 subjects . Compared with sham smoking , cigarette smoking alone increased blood pressure and decreased muscle SNA . When the blood pressure increase in response to smoking was blunted by nitroprusside infusion , there was a striking increase in muscle SNA . Muscle SNA increased up to 3-fold the levels seen before smoking ( P<0.001 ) , accompanied by an increase in heart rate of up to 37+/-4 bpm . Cigarette smoking also induced a 102+/-22 % increase in skin SNA ( P=0.03 ) . CONCLUSIONS These data provide the first direct evidence that cigarette smoking increases sympathetic outflow Cigarette smoking is associated with impaired endothelium‐dependent dilatation in human veins and arteries . An in vivo study in animals suggests that nicotine may contribute to this abnormality . We tested the hypothesis that local administration of nicotine at a dose reproducing the plasma concentration observed during smoking would impair endothelium‐dependent vasodilatation in human veins in vivo Using a reliable , newly developed assay for ascorbic acid ( reduced form ) and dehydroascorbic acid ( DHAA ; the oxidized form ) in plasma , we studied the influence of age , sex , and smoking on 219 healthy , age-stratified , and r and omly selected subjects representing the Danish population . The mean ( + /-SD ) plasma total ascorbic acid ( ascorbic acid + DHAA ) concentration was lower in smokers ( 62.8 + /- 24.9 mumol/L ) than in nonsmokers ( 74.9 + /- 23.6 mumol/L ) ( P < 0.001 ) and the DHAA content was 1.8 + /- 4.0 % of the total ascorbic acid in smokers compared with 0.1 + /- 3.1 % in nonsmokers ( P < 0.001 ) . A significant inverse correlation between the DHAA fraction and the total ascorbic acid concentration was found in smokers ( P < 0.002 ) but not in smokers ; the slopes of the linear regressions were significantly different in the two groups ( P < 0.005 ) . The mean plasma concentration of total ascorbic acid was higher in females than in males ( P < 0.005 ) ; this difference persisted in multivariate analysis when smoking was adjusted for . No age dependence could be identified . The data show that smoking results in severe oxidative stress , depletion of the ascorbic acid pool , and insufficient reduction capacity to maintain ascorbic acid in the reduced form in plasma . We suggest that the additional analysis of DHAA allows further differentiation in the assessment of oxidative stress and may provide an objective way of determining vitamin C requirements in smokers . Preliminary findings suggest that a vitamin C dose that results in a plasma concentration of approximately 70 mumol/L or higher is required in smokers BACKGROUND An association between smoking and impaired wound healing has been reported in retrospective studies . The smoking status of a surgical patient may be confounded by social and medical parameters . We have evaluated the effect of smoking in a test wound in volunteers , with special reference to a reliable scientific match between smokers and nonsmokers . METHODS In a prospect i ve open study with blinded assessment , 19 smoking ( 20 cigarettes/day ) and 18 nonsmoking healthy volunteers were matched with respect to baseline characteristics . The deposition of total protein and mature collagen ( expressed as hydroxyproline ) was assessed in an exp and ed polytetrafluoroethylene wound healing model implanted subcutaneously for 10 days . RESULTS The nonsmokers had a 1.8 times higher median amount of hydroxyproline than the smokers ( p < 0.01 ) . The deposition of hydroxyproline was negatively correlated with the consumption of tobacco both before ( r = -0.44 ; p < 0.01 ) and during the study ( r = -0.48 ; p < 0.005 ) . The impairment was specific for the production of collagenous proteins and not other proteins . CONCLUSIONS The synthesis of subcutaneous collagen in smokers is specifically impeded , indicating an impaired wound-healing process . Because mature collagen is the main determinator of strength of an operative wound , the results support the view that patients should be advised to stop smoking before an operation Objective —The role of antioxidants in preventing vascular disease remains controversial . Vascular endothelial growth factor ( VEGF-A ) is important for endothelial and monocyte function . This study investigated the negative effects of smoking on monocyte migratory responsiveness to VEGF-A and the usefulness of vitamin C to prevent smoking-induced monocyte dysfunction . Methods and Results —The chemotactic response of isolated monocytes from a cohort of 17 non-smokers and 10 smokers toward VEGF-A was assessed . VEGF-A significantly stimulated the migration of monocytes in non-smokers ; the monocytes from smokers failed to respond to VEGF-A. Repeated analysis after 2 weeks of vitamin C intake ( 2g/d ) showed a fully restored VEGF-A – induced monocyte migration in smokers . VEGF-A serum levels were not altered by vitamin C. VEGF-A – inducible kinase activity was intact in monocytes from smokers as assessed by in vitro kinase assay . Monocyte dysfunction can be mimicked in vitro by challenging monocytes with a range of reactive oxygen species ( ROS ) . Conclusions —Stimulation of monocyte migration by VEGF-A was severely attenuated in smokers , and the deficit observed was surmounted by vitamin C supplementation . The negative effects of smoking on monocyte function may translate into adverse impacts on VEGF-A – dependent repair processes such as arteriogenesis . These results propose a causative role of oxidative stress in smoking-induced monocyte dysfunction Higher white blood cell counts in smokers compared with nonsmokers have been well documented , but the longitudinal relation between changes in smoking and changes in white blood cells has not been well described . Since 1984 , data have been collected semiannually by the Multicenter AIDS Cohort Study ( MACS ) , a four-center prospect i ve cohort study of acquired immunodeficiency syndrome ( AIDS ) in homosexual men . The study population includes 2,435 participants who were human immunodeficiency virus ( HIV ) seronegative as of September 1994 and who contributed 20,918 person-visits for this analysis . For individuals who modified their smoking behavior , changes in white blood cell counts occurred primarily during the first 6 months following changes in the amount of cigarettes smoked . Among former smokers who resumed smoking , the extent of the increase in white blood cell count depended on the number of cigarettes smoked . Specifically , increases of 241 , 340 , and 740 cells/microliter were observed for smokers who resumed smoking < 1 , 1 to < 2 , and > or = 2 packs/day , respectively . Conversely , smokers who quit smoking had a decrease of white blood cell count : -32 , -629 , and -1,122 cells/microliter for men who previously smoked < 1 , 1 to < 2 , and > or = 2 packs/day , respectively . Long-term ex-smokers , however , still had higher white blood cell counts than did never smokers . There was a high within-individual correlation of white blood cell count in persons who reported a consistent level of smoking ( i.e. , average correlations between two white blood cell counts 6 years apart were 0.51 for never smokers , 0.48 for ex-smokers , 0.56 for men who smoked < 1 pack/day , and 0.43 for men who smoked > or = 1 pack/day ) . These analyses indicate an acute effect of changes in smoking on changes in white blood cell count , a residual effect of having been a smoker , and high long-term tracking for white blood cell count BACKGROUND Smokers are at higher risk of cardiopulmonary and wound-related postoperative complications than non-smokers . Our aim was to investigate the effect of preoperative smoking intervention on the frequency of postoperative complications in patients undergoing hip and knee replacement . METHODS We did a r and omised trial in three hospitals in Denmark . 120 patients were r and omly assigned 6 - 8 weeks before scheduled surgery to either the control ( n=60 ) or smoking intervention ( 60 ) group . Smoking intervention was counselling and nicotine replacement therapy , and either smoking cessation or at least 50 % smoking reduction . An assessor , who was masked to the intervention , registered the occurrence of cardiopulmonary , renal , neurological , or surgical complications and duration of hospital admittance . The main analysis was by intention to treat . FINDINGS Eight controls and four patients from the intervention group were excluded from the final analysis because their operations were either postponed or cancelled . Thus , 52 and 56 patients , respectively , were analysed for outcome . The overall complication rate was 18 % in the smoking intervention group and 52 % in controls ( p=0.0003 ) . The most significant effects of intervention were seen for wound-related complications ( 5 % vs 31 % , p=0.001 ) , cardiovascular complications ( 0 % vs 10 % , p=0.08 ) , and secondary surgery ( 4 % vs 15 % , p=0.07 ) . The median length of stay was 11 days ( range 7 - 55 ) in the intervention group and 13 days ( 8 - 65 ) in the control group . INTERPRETATION An effective smoking intervention programme 6 - 8 weeks before surgery reduces postoperative morbidity , and we recommend , on the basis of our results , this programme be adopted Delayed wound healing may explain postoperative tissue and wound dehiscence in smokers , but the effects of smoking and smoking cessation on the cellular mechanisms remain unclear . Suction blisters were raised in 48 smokers and 30 never smokers . The fluid was retrieved and the epidermal roof was excised . Transepidermal water loss ( TEWL ) was measured after 2 , 4 , and 7 days . Then , the smokers were r and omized to continuous smoking or abstinence with a transdermal nicotine patch or a placebo by concealed allocation . The sequence was repeated after 4 , 8 , and 12 weeks in all smokers and abstainers and in 6 never smokers . Matrix metalloproteinase (MMP)-8 and MMP-1 levels in suction blister fluid were assessed by an enzyme-linked immunosorbent assay . R and om-effects models for repeated measurements were applied and p < or = 0.05 was considered significant . One week after wounding the TEWL was 17.20 ( 14.47 - 19.92 ) g/cm(2 ) hour ( mean , 95 % CI ) in smokers and 13.89 ( 9.46 - 18.33 ) in never smokers ( p<0.01 ) . In abstinent smokers TEWL was 18.95 (15.20 - 22.70)(p<0.01 , when compared with smokers ) . In smokers , MMP-8 was 36.4 ( 24.3 - 48.5 ) ng/mL ( mean , 95 % CI ) and 15.2 ( 1.4 - 30.2 ) ng/mL in never smokers ( p<0.01 ) . Abstinent smokers ' MMP-8 level was 21.2 ng/mL ( 6.6 - 43.0 ) ( p=0.02 , when compared with smokers ) . MMP-1 was unaffected by smoking and abstention . Transdermal nicotine patch did not affect any parameter . We conclude that smoking attenuates epidermal healing and may enhance extracellular matrix degradation . Three months of abstinence from smoking does not restore epidermal healing , whereas 4 weeks of abstinence normalizes suction blister MMP-8 levels . These findings suggest sustained impaired wound healing in smokers and potential reversibility of extracellular matrix degradation OBJECTIVES We sought to determine the effects of nicotine patch therapy , when used to promote smoking cessation , on myocardial ischemia in patients with coronary artery disease . BACKGROUND Nicotine patches substantially increase quit rates among cigarette smokers , but their safety in patients with myocardial ischemia who are attempting to quit smoking is unknown . METHODS This is a \n Output:\n " }, { "from": "agent", "value": "RESULTS Smoking decreases tissue oxygenation and aerobe metabolism temporarily .\nThe inflammatory healing response is attenuated by a reduced inflammatory cell chemotactic responsiveness , migratory function , and oxidative bactericidal mechanisms .\nIn addition , the release of proteolytic enzymes and inhibitors is imbalanced .\nThe proliferative response is impaired by a reduced fibroblast migration and proliferation in addition to a downregulated collagen synthesis and deposition .\nSmoking cessation restores tissue oxygenation and metabolism rapidly .\nInflammatory cell response is reversed in part within 4 weeks , whereas the proliferative response remains impaired .\nNicotine does not affect tissue microenvironment , but appears to impair inflammation and stimulate proliferation .\nCONCLUSIONS Smoking has a transient effect on the tissue microenvironment and a prolonged effect on inflammatory and reparative cell functions leading to delayed healing and complications .\nSmoking cessation restores the tissue microenvironment rapidly and the inflammatory cellular functions within 4 weeks , but the proliferative response remain impaired .\nNicotine and nicotine replacement drugs seem to attenuate inflammation and enhance proliferation but the effect appears to be marginal" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: CONTEXT The prevalence of medical disorders is high among substance abuse patients , yet medical services are seldom provided in coordination with substance abuse treatment . OBJECTIVE To examine differences in treatment outcomes and costs between integrated and independent models of medical and substance abuse care as well as the effect of integrated care in a subgroup of patients with substance abuse-related medical conditions ( SAMCs ) . DESIGN R and omized controlled trial conducted between April 1997 and December 1998 . SETTING AND PATIENTS Adult men and women ( n = 592 ) who were admitted to a large health maintenance organization chemical dependency program in Sacramento , Calif. INTERVENTIONS Patients were r and omly assigned to receive treatment through an integrated model , in which primary health care was included within the addiction treatment program ( n = 285 ) , or an independent treatment-as-usual model , in which primary care and substance abuse treatment were provided separately ( n = 307 ) . Both programs were group based and lasted 8 weeks , with 10 months of aftercare available . MAIN OUTCOME MEASURES Abstinence outcomes , treatment utilization , and costs 6 months after r and omization . RESULTS Both groups showed improvement on all drug and alcohol measures . Overall , there were no differences in total abstinence rates between the integrated care and independent care groups ( 68 % vs 63 % , P = .18 ) . For patients without SAMCs , there were also no differences in abstinence rates ( integrated care , 66 % vs independent care , 73 % ; P = .23 ) and there was a slight but nonsignificant trend of higher costs for the integrated care group ( $ 367.96 vs $ 324.09 , P = .19 ) . However , patients with SAMCs ( n = 341 ) were more likely to be abstinent in the integrated care group than the independent care group ( 69 % vs 55 % , P = .006 ; odds ratio [ OR ] , 1.90 ; 95 % confidence interval [ CI ] , 1.22 - 2.97 ) . This was true for both those with medical ( OR , 3.38 ; 95 % CI , 1.68 - 6.80 ) and psychiatric ( OR , 2.10 ; 95 % CI , 1.04 - 4.25 ) SAMCs . Patients with SAMCs had a slight but nonsignificant trend of higher costs in the integrated care group ( $ 470.81 vs $ 427.95 , P = .14 ) . The incremental cost-effectiveness ratio per additional abstinent patient with an SAMC in the integrated care group was $ 1581 . CONCLUSIONS Individuals with SAMCs benefit from integrated medical and substance abuse treatment , and such an approach can be cost-effective . These findings are relevant given the high prevalence and cost of medical conditions among substance abuse patients , new developments in medications for addiction , and recent legislation on parity of substance abuse with other medical benefits OBJECTIVE This article examines client drinking and related psychosocial functioning during the course of alcoholism treatment . It focuses on ( 1 ) the main effects of the three Project MATCH treatments , ( 2 ) the prognostic value of client attributes employed in the matching hypotheses , and ( 3 ) the attribute by treatment interaction effects . METHOD Clients recruited from outpatient setting s ( n = 952 ) or from aftercare setting s ( n = 774 ) were r and omized to one of the following treatments : Motivational Enhancement Therapy ( MET ) , Cognitive Behavioral Therapy ( CBT ) and Twelve-Step Facilitation ( TSF ) . Alcohol consumption and psychosocial functioning during treatment were assessed at the end of the 12-week treatment phase . RESULTS During the treatment phase , small but statistically significant differences among treatments were found only in the outpatient arm on measures of alcohol consumption and alcohol-related negative consequences . Forty-one percent ( 41 % ) of CBT and TSF clients were abstinent or drank moderately without alcohol-related consequences , compared with 28 % of MET clients . Tests of 10 a priori primary client-treatment matching hypotheses failed to find any interaction effects that had an impact on drinking throughout the treatment phase . CONCLUSIONS In the outpatient setting there appears to be a temporary advantage to assigning individuals to CBT or TSF rather than MET . When there is a need to quickly reduce heavy drinking and alcohol-related consequences , it appears that CBT or TSF should be the treatment of choice Objective : Mobile technology has the potential to radically improve addiction treatment and continuing care by offering emotional and instrumental support anywhere and just in time . This is particularly important in addiction because timing is critical to preventing relapse . Although most experts consider alcoholism to be a chronic disease , providers do not typically offer ongoing support for relapse prevention after patients complete treatment , even though a central characteristic of alcoholism and other addictive behaviors is their chronically relapsing nature . A-CHESS is a smartphone-based system for preventing relapse to heavy drinking among people leaving active alcohol dependence treatment . A-CHESS is design ed to improve competence , social relatedness , and motivation , the three tenets of self-determination theory . This paper reports on the relative impact and use of A-CHESS 4 months after patients entered the study and discusses implication s of the results on treating addiction and chronic diseases generally . Methods : A total of 349 individuals with alcohol dependence leaving residential treatment were r and omly assigned to either receive A-CHESS + Treatment as usual or treatment as usual ( st and ard aftercare ) . Patients came from two treatment agencies , one in the Midwest and one in the Northeast . Patients assigned to A-CHESS received a smartphone for 8 months and were followed for 12 . The authors analyzed use patterns during the first 4 months of use by those receiving A-CHESS . Results : Participants used A-CHESS heavily and sustained their use over time . Ninety-four percent of A-CHESS participants used the application during the first week after residential treatment . At week 16 , almost 80 % continued to access A-CHESS . Participants with alcohol and drug dependence showed higher levels of system use than those with alcohol dependence only . Participants with a mental health diagnosis had slightly lower levels of use at the end of the intervention period ( week 16 ) , although more than 70 % still accessed the system . Conclusions : These findings illustrate that patients with alcohol dependence , alcohol and drug dependence , and mental health issues will use smartphone applications such as A-CHESS for ongoing support , re sources , and information , thus extending patient care if given the opportunity . Further analysis is needed to determine whether sustained A-CHESS use improves outcomes . This clinical trial is registered at www . clinical trials.gov as trial # NCT01003119 Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Developed and evaluated a home-based contracting program to determine its effect on the compliance rates of discharged alcohol patients to a disulfiram ( antabuse ) regimen . The three comparison groups included ( a ) no contract/no recording ; ( b ) contract/recording ; and ( c ) contract/recording plus instructions for positive reinforcement . Twenty-five patients who had been treated in a behaviorally oriented inpatient alcohol dependence treatment program and who lived with a significant other ( i.e. , spouse , sibling , parent ) participated in the study . At the end of the 3-month period for which the disulfiram was prescribed , those Ss who were involved in contracting and recording reached criterion more frequently than those who were in the minimal treatment group . Furthermore , 84 % of this S sample were abstinent at the 3-month follow-up according to collateral reports . The discussion centers on the use of home-based contracting as an inexpensive alternative to other , more costly disulfiram programs . Additional methods for obtaining measures of reliability on self-report of disulfiram usage also are discussed Alcoholics from two hospital-based treatment centers participated in an experimental test of the effects of extended aftercare on inpatient recovery rates . At discharge from inpatient treatment , subjects were r and omly assigned either to an experimental group scheduled to be called by a center counselor every 2 weeks for 1 year or to a control group that experienced only the usual treatment . Follow-up interviews conducted approximately 12 months after hospital discharge found that the experimental group had no higher recovery rates than the control group . There was weak evidence that the calls reduced the burden that alcoholics place on community control and service agencies . There was no evidence that either the phone calls were more effective for some patients than for others or that some kinds of phone calls were more effective than others . Although most subjects said they liked the calls , wanted them to continue and perceived them as \" good treatment , \" only one subject gave the calls credit for helping him maintain sobriety This study evaluated whether alcoholics who received couples relapse prevention ( RP ) sessions in the year after short-term behavioral marital therapy ( BMT ) did better than those who did not receive additional RP . Couples ( n = 59 ) with an alcoholic husb and , after participating in weekly BMT couples sessions for 5 months , were assigned r and omly to receive or not receive 15 additional conjoint couples relapse prevention ( RP ) sessions over the next 12 months . Outcome measures were collected before and after BMT and at quarterly intervals for the year after BMT . Significant improvements in the alcoholics ' drinking and the couple 's marital adjustment occurred from before to after BMT replicating results of our own and other 's earlier studies of BMT with alcoholics , and outcomes remained significantly improved through 12-months follow-up independent of the amount of aftercare received . Given these favorable outcomes overall , the present study provided a stringent test of the hypothesized utility of RP . As predicted , alcoholics who received RP after BMT had more days abstinent and fewer days drinking , maintained their improved marriages better and used behaviors targeted by BMT more than those who received BMT alone . The prediction that greater continued use of behaviors targeted by BMT would be associated with better outcomes irrespective of the amount of aftercare received also was supported . The final prediction that couples with more severe alcohol and marital problems at study entry would show the greatest additional benefit from RP was not supported . The relatively clear-cut findings favoring RP may be due to the fact that RP in this study was an intensive , multifaceted booster maintenance intervention delivered in a couples format over a lengthy period of time . Moreover , the present results occurred during the time that couples were still getting RP . Limitations to the generalizability and interpretation of the results are discussed OBJECTIVE To examine the impact of three common comorbid disorders on a variety of outcomes 3 years after inpatient alcoholism treatment . METHOD Using a prospect i ve cohort design , we examined the frequency and intensity of drinking , the severity of alcohol-related symptoms , global alcohol-related outcome and severity of psychiatric symptoms in a group of 225 ( 74 % male ) alcoholics . At the index admission , patients were categorized as to the lifetime presence of major depression , antisocial personality disorder ( ASP ) and drug abuse/dependence . Multiple linear regression was used hierarchically to step in blocks of predictors in a logical sequence : ( 1 ) gender and age ; ( 2 ) number of comorbid psychiatric diagnoses and the presence or absence of the three individual comorbid psychiatric disorders ; and ( 3 ) the interaction between gender and each of the three diagnostic groups . RESULTS Men showed greater intensity of drinking , more alcohol-related symptoms and poorer global alcohol-related outcome . Younger patients also showed more alcohol-related symptoms . Although the number of comorbid diagnoses was correlated with both the intensity of drinking and the severity of psychopathology , each of the specific comorbid diagnoses accounted for unique variance in outcome . Comorbid drug abuse/dependence was associated with more drinking days and more alcohol-related symptoms . In contrast , the presence of comorbid major depression was associated with lower intensity of drinking . Finally , ASP was associated with poorer global alcohol-related outcome . CONCLUSIONS Outcomes 3 years after alcoholism treatment are related to the presence of specific lifetime comorbid psychiatric diagnoses . Since such disorders may positively influence the course of alcoholism , trials of clinical interventions that target these disorders are warranted AIMS To measure the effect of community nurse follow-up on abstinence and retention rates in the outpatient treatment of alcohol-dependent patients treated with acamprosate . METHODS Recently detoxified alcohol-dependent patients were prescribed acamprosate for 26 weeks and r and omized to either physician-only follow-up , or physician plus regular visits from a community nurse . Drinking behaviour in the next 26 weeks was assessed at monthly visits to non-blind clinicians . RESULTS The cumulative abstinence duration proportion ( CADP ) was significantly longer in ( P=0.03 ) the subjects who had received community nurse support ( 0.57 ) than in those who had not ( 0.39 ) . This might , in part , be an artefact of the higher retention rate among those followed up by the nurse , in that , the method of calculating CADP allocates 100 % days of drinking for the month before a failed attendance . Differences favouring nurse in the follow-up were seen for time to first drink , and clinical global impression . CONCLUSIONS For recently detoxified alcohol-dependent patients treated with acamprosate , follow-up by a community nurse improves patient retention and probably also improves the 6-month drinking outcome Objective : In spite of the increasing interest in out‐patient treatment programmes for alcoholics , there still exist only a few experimental studies on this issue . In this still ongoing study the efficacy of different behaviour therapy strategies is \n Output:\n " }, { "from": "agent", "value": "Adding an active intervention to usual continuing care seems to improve treatment outcomes ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: A r and omized comparison group pretest-posttest experimental design was used to quantitatively determine the effects of environmental control measures on patients with allergic rhinitis . Environmental controls included wrapping the mattress with a vinyl cover , washing the top bedding cover with 55 degrees C hot water every two weeks , removal of soft furniture , and wet cleaning of the bedroom floor every day . Thirty subjects were r and omly assigned to experimental and control groups . The amount of house dust mites in dust sample s collected from the bedroom floor , bedding and mattress , as well as the nasal symptoms of patients , were measured twice at one-month intervals . A significant decrease in house dust mites in dust sample s and relief in patients ' nasal symptoms were observed in the experimental group who had environmental controls Background : Environmental control has been put forward as an integral part of the management of house dust mite ( HDM ) allergy in sensitized patients . To vali date this statement allergic disorders involved in HDM allergy – allergic asthma , rhinitis and atopic eczema/dermatitis syndrome ( AEDS ) – should be taken together and studied in terms of the efficacy of environmental control . Because a generic quality of life question naire exceeds the border of disease , this may be used as major outcome parameter BACKGROUND Encasing bedding in impermeable covers reduces exposure to house-dust mites , but the clinical benefit of this intervention as part of mite-avoidance measures for patients with allergic rhinitis is not known . We performed a multicenter , r and omized , placebo-controlled trial of one year of use of impermeable bedding covers in the bedrooms of patients with rhinitis who were sensitized to house-dust mites to determine the effects on the signs and symptoms of disease . METHODS Three participating university medical centers enrolled 279 patients with allergic rhinitis who were r and omly assigned to receive impermeable or non-impermeable ( control ) covers for their mattress , pillow , and duvet or blanket . At the start of the study , all participants received information on general allergen-avoidance measures . The severity of rhinitis was measured on a rhinitis-specific visual-analogue scale and by means of a daily symptom score and nasal allergen provocation testing . We also measured the concentrations of Dermatophagoides pteronyssinus ( Der p1 ) and D. farinae ( Der f1 ) in dust from patients ' mattresses , bedroom floors , and living-room floors at base line and after 12 months as a measure of the efficacy of the intervention . RESULTS A total of 232 patients completed the study . There was a significant reduction in Der p1 and Der f1 concentrations in the mattresses of the impermeable-cover group , whereas there was no significant reduction in the control group . However , there was no significant effect on the clinical outcome measures . Analyses of subgroups defined according to age , level of exposure , type and severity of sensitization , or characteristics of the patient 's home had similar results . CONCLUSIONS Mite-proof bedding covers , as part of a structured allergy-control program , reduced the level of exposure to mite allergens . Despite the success of the intervention , this single avoidance measure did not lead to a significant improvement of clinical symptoms in patients with allergic rhinitis A double blind , r and omized , comparative study versus placebo , was done during 6 months in 32 children , aged 4 - 12 years , who suffer from either allergic asthma or rhinitis or both , slept in a bedroom rich in dust mite , have well documented allergy solely to house dust mite ( H.D.M. ) , and a condition severe enough to require continuous medication . After thorough cleaning , their bedrooms were sprayed on day 0 and day 90 with the total content of a canister containing either Acardust or Placebo . Rooms were cleaned regularly throughout the study period . Each child completed an individual daily score card ( scales from 0 - 3 ) for asthma , and rhinitis symptoms , medication taken , and any additional symptoms . Peak flow was recorded twice weekly . All the children were examined every month ( at the clinic ) when also PFF , FEVI , doctor 's and patient 's opinion of clinical symptoms were recorded according to the same scale ( 0 - 3 ) and dust sample s from child 's bedroom were examined for H.D.M. antigen content . At day 0 , 90 and 180 , total IgE and dust mite specific IgE determination was done . At the end of the study , patient 's and doctor 's opinion about the spray 's efficacy were recorded on a scale from 0 - 3 . The results were in favor of Acardust for asthma , according to patient 's opinion ( p = 0.001 ) , doctor 's opinion ( p = 0.04 ) and individual score cards ( p = 0.03 ) , and for nasal secretion ( p = 0.01 ) , sneezing and lacrimation ( p = 0.02 ) ; concurrent medication dropped significantly ( p = 0.01 ) in the Acardust group . No side-effects were reported . We consider Acardust a safe and valuable preventive treatment in H.D.M. allergy BACKGROUND Data for trends in prevalence of asthma , allergic rhinoconjunctivitis , and eczema over time are scarce . We repeated the International Study of Asthma and Allergies in Childhood ( ISAAC ) at least 5 years after Phase One , to examine changes in the prevalence of symptoms of these disorders . METHODS For the ISAAC Phase Three study , between 2002 and 2003 , we did a cross-sectional question naire survey of 193,404 children aged 6 - 7 years from 66 centres in 37 countries , and 304,679 children aged 13 - 14 years from 106 centres in 56 countries , chosen from a r and om sample of schools in a defined geographical area . FINDINGS Phase Three was completed a mean of 7 years after Phase One . Most centres showed a change in prevalence of 1 or more SE for at least one disorder , with increases being twice as common as decreases , and increases being more common in the 6 - 7 year age-group than in the 13 - 14 year age-group , and at most levels of mean prevalence . An exception was asthma symptoms in the older age-group , in which decreases were more common at high prevalence . For both age-groups , more centres showed increases in all three disorders more often than showing decreases , but most centres had mixed changes . INTERPRETATION The rise in prevalence of symptoms in many centres is concerning , but the absence of increases in prevalence of asthma symptoms for centres with existing high prevalence in the older age-group is reassuring . The divergent trends in prevalence of symptoms of allergic diseases form the basis for further research into the causes of such disorders This study was design ed to assess the effectiveness of a high-efficiency particulate air ( HEPA ) filter in alleviating allergic respiratory symptoms . Thirty-two patients were studied who had symptomatic perennial rhinitis and /or asthma during the fall and winter months and had a positive skin test with house dust or house dust -- mite extract . An ENVIRACAIRE room air cleaner was placed in the bedroom for 8 weeks . In a r and om manner , the active filter was used for 4 weeks and a blank filter for 4 weeks . There was an average 70 % reduction in the particulate matter greater than or equal to 0.3 micron with the HEPA filter . In a double-blind design , results were assessed by analysis of the patients ' symptom/medication scores and subjective evaluation . For the total study , there was no difference in the total symptom/medication scores or individual symptom scores during the placebo and active-filter periods . Analysis of the last 2 weeks of each filter period in which respiratory infection was absent demonstrated definite differences in total and individual symptoms , suggesting active-filter benefit . Patients ' subjective responses also suggested benefit from the filter . The overall impression is that the HEPA filter can reduce allergic respiratory symptoms UNLABELLED The aim of this intervention study was to identify any health improvements in the upper and lower airways of office workers after the installation of local electrostatic air cleaners . Eighty persons with airways symptoms were recruited and r and omly assigned to an intervention or control group . Half of the air cleaners had a non-functioning electrostatic unit . Both participants and field research ers were blinded to the group status . Subjective symptoms were recorded using a question naire , and indexes calculated for general , irritation and skin symptoms . Objective respiratory health indicators were recorded , with acoustic rhinometry and peak expiratory flow ( PEF ) meters . In the intervention group there was a decrease in mean dust concentration from 65 to 35 microg/m(3 ) , and a reduction from 57 to 47 microg/m(3 ) in the control group ( P < 0.05 for difference in decline ) . The reduction was observed for all particles sizes . The irritation and general symptom indices decreased in both groups , but there was no improvement in the intervention group , compared with the control group . Median PEF increased 3 ml/s in the intervention group , and decreased 4 ml/s in the control group . The adjusted odds ratio for an increase above the 70th percentile was 5.7 ( 95 % CI 1.0 - 32 ) . PRACTICAL IMPLICATION S Electrostatic air cleaners can reduce the dust concentration effectively in the office environment . Small , medium and large sized particles can be reduced by approximately 50 % , relatively most effectively for the respirable particles . However , the air cleaners tested in this study produced an annoying fan noise . Cleaning efficiency and noise data should be given consideration before installation . This experimental field study suggests that office workers with airways symptoms may benefit from installation of local electrostatic air cleaners N-(3,4-dimethoxycinnamoyl ) anthranilic acid ( N-5 ' ) , a new orally useable mast cell stabilizer , was investigated for its efficacy , safety and usefulness in the treatment of 302 patients with perennial nasal allergy by an intergroup , double-blind comparative test using disodium cromoglycate ( DSCG ) and an inactive placebo as control . The results indicated that N-5 ' , as a mild mast cell stabilizer , was comparable to DSCG in efficacy and minimum in side effect The efficacy of an air‐cleaning device equipped with a high efficiency particulate air ( HEPA ) filter ( without further avoidance measures ) was studied in patients allergic to house dust mite . The effects of the air‐cleaner on indoor Dermatophagoides sp. levels , symptom score and bronchial hyperresponsiveness in nine mite‐allergic patients were assessed using a cross‐over controlled study . No significant effect was demonstrated on indoor Dermatophagoides sp. levels when comparing the period of air‐cleaner activity ( 2 months ) with the control period ( 2 months ) . The Dermatophagoides sp. levels in the houses studied were lower than the risk level for asthmatic attacks , making it difficult to assess any effect on asthma ; however , neither bronchial hyperresponsiveness nor rhinitis symptom score were changed by air‐cleaner activity . During the trial period , however the mean level of Dermatophagoides sp. allergen in the houses changed spontaneously from 4.4 Hg/g ( mean level in the first 2 trial months ) to 1 . 75 μg/g of dust ( second 2 months ) ( P < 0.05 ) . Owing to this change , the mean rhinitis symptom score also decreased ( P < 0.05 ) , even if no significant correlation was demonstrated ( r = 0.4 P= 0.089 ) . HEPA filter air‐cleaners appear insufficient as substitutes for st and ard avoidance measures in mite allergic patients Inheritance and allergen exposure are key factors in the development and the course of atopic allergy , expressed as conjunctivitis , rhinitis , asthma or dermatitis . This study concerns the clinical significance of mite and mite‐allergen avoidance measures based on intensive cleaning with acaricide ( solidified benzylbenzoate ) added ( 10 dwellings ) , and without biocidal activity ( 10 other homes ) as a control in a double‐blind trial with matched pairs . Twenty subjects with persisting rhinitic complaints were selected . They lived in 20 different dwellings and were ail sensitized to pyroglyphid mites ; 12 of them were also sensitized to stored product miles ( Acari ) . Daily symptoms and medication score , guanine and dust exposure , total and mite‐specific IgE in serum , eosinophilia in the blood and in the nasal smear , intracutaneous tests with house dust mite and storage mite extracts were compared in both pairs and groups . Acarological data , physiochemical aspects and exposure assessment are discussed in detail elsewhere . Symptom scores dropped significantly , as did the total IgE and exposure to dust and mite products in the acaricidal cleaner treatment group . After 1 year , the daily symptoms median was 47 % ( P= 0.025 ) , total IgE was 38 % ( P=0.0049 ) , and exposure to dust and mite products ( guanine exposure ) was 53 % ( P= 0.0449 ) better or lower than in the controls . Intensive cleaning , without acaricidal treatment performed twice a year , result ed in clinical improvement in four out of 10 subjects , of whom none became free of complaints . In the Acarosan treatment group ( cleaning+ benzylbenzoate ) eight out of 10 subjcets improved , in three cases subjective symptoms disappeared . The conclusion is that mite avoidance in homes can be carried out successfully with a special acaricidal cleaning formulation Acarosan We report on the mechanisms , the environmental changes and patient compliance with regard to conventional and new dust and mite avoidance measures to prevent allergic symptoms caused by mite allergens , taking into account both allergen contamination and the developmental success of pyroglyph \n Output:\n " }, { "from": "agent", "value": "House dust mite impermeable bedding as an isolated intervention is unlikely to offer clinical benefit .\nTrials to date have on the whole been small and of poor method ological quality , making it difficult to offer any definitive recommendations on the role , if any , of house dust mite avoidance measures in the management of house dust mite sensitive perennial allergic rhinitis .\nThe results of these studies suggest that use of acaricides and extensive bedroom-based environmental control programmes may be of some benefit in reducing rhinitis symptoms and , if considered appropriate , these should be the interventions of choice .\nIsolated use of house dust mite impermeable bedding is unlikely to prove effective" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: GS-5816 is an inhibitor of the hepatitis C virus ( HCV ) NS5A protein that has demonstrated pan-genotypic activity and a high barrier to resistance in HCV replicon assays . The aim of this study was to evaluate the safety , antiviral activity and pharmacokinetics of once-daily doses of GS-5816 in patients with genotype 1 - 4 HCV infection . Patients with genotype 1 - 4 HCV infection were r and omized to 3 days of GS-5816 at doses ranging from 5 to 150 mg or placebo . Adverse events were recorded , and plasma sample s obtained for analysis of pharmacokinetics , HCV RNA and NS5A sequencing studies . GS-5816 5 - 150 mg for 3 days was well tolerated and result ed in rapid declines in HCV RNA that were sustained over the dosing period . In patients treated with the 150 mg dose of GS-5816 , the mean maximal HCV RNA declines were 4.0 , 4.0 , 4.4 , 3.3 and 3.5 log10 IU/mL in patients with genotype 1a , 1b , 2 , 3 and 4 HCV infection , respectively . Pretreatment NS5A resistance-associated polymorphisms were detected in 31 % ( 22/70 ) of patients . Genotype 1 and 3 HCV-infected patients without pretreatment NS5A resistance-associated polymorphisms had greater declines in HCV RNA than patients with resistance-associated polymorphisms . Plasma pharmacokinetics were supportive of once-daily dosing . GS-5816 demonstrated pangenotypic antiviral activity in patients with genotype 1 - 4 HCV infection . It will be further evaluated in combination with other pangenotypic direct-acting antivirals to achieve the goal of developing a well-tolerated , highly effective treatment for all HCV genotypes BACKGROUND Patients chronically infected with hepatitis C virus ( HCV ) genotype 2 or 3 for whom treatment with peginterferon is not an option , or who have not had a response to prior interferon treatment , currently have no approved treatment options . In phase 2 trials , regimens including the oral nucleotide polymerase inhibitor sofosbuvir have shown efficacy in patients with HCV genotype 2 or 3 infection . METHODS We conducted two r and omized , phase 3 studies involving patients with chronic HCV genotype 2 or 3 infection . In one trial , patients for whom treatment with peginterferon was not an option received oral sofosbuvir and ribavirin ( 207 patients ) or matching placebo ( 71 ) for 12 weeks . In a second trial , patients who had not had a response to prior interferon therapy received sofosbuvir and ribavirin for 12 weeks ( 103 patients ) or 16 weeks ( 98 ) . The primary end point was a sustained virologic response at 12 weeks after therapy . RESULTS Among patients for whom treatment with peginterferon was not an option , the rate of a sustained virologic response was 78 % ( 95 % confidence interval [ CI ] , 72 to 83 ) with sofosbuvir and ribavirin , as compared with 0 % with placebo ( P<0.001 ) . Among previously treated patients , the rate of response was 50 % with 12 weeks of treatment , as compared with 73 % with 16 weeks of treatment ( difference , -23 percentage points ; 95 % CI , -35 to -11 ; P<0.001 ) . In both studies , response rates were lower among patients with genotype 3 infection than among those with genotype 2 infection and , among patients with genotype 3 infection , lower among those with cirrhosis than among those without cirrhosis . The most common adverse events were headache , fatigue , nausea , and insomnia ; the overall rate of discontinuation of sofosbuvir was low ( 1 to 2 % ) . CONCLUSIONS In patients with HCV genotype 2 or 3 infection for whom treatment with peginterferon and ribavirin was not an option , 12 or 16 weeks of treatment with sofosbuvir and ribavirin was effective . Efficacy was increased among patients with HCV genotype 2 infection and those without cirrhosis . In previously treated patients with genotype 3 infection , 16 weeks of therapy was significantly more effective than 12 weeks . ( Funded by Gilead Sciences ; POSITRON and FUSION Clinical Trials.gov numbers , NCT01542788 and NCT01604850 , respectively . ) BACKGROUND The uridine nucleotide analogue sofosbuvir is a selective inhibitor of hepatitis C virus ( HCV ) NS5B polymerase . We assessed the safety and efficacy of sofosbuvir in combination with pegylated interferon alfa-2a ( peginterferon ) and ribavirin in non-cirrhotic treatment-naive , patients with HCV . METHODS For this open-label , r and omised phase 2 trial , we recruited patients from 42 centres in the USA and Puerto Rico between March 23 , 2011 , and Sept 21 , 2011 . Patients were eligible for inclusion if they had chronic HCV infection ( genotypes 1 , 4 , 5 , or 6 ) , were aged 18 years or older , and had not previously received treatment for HCV infection . Using a computer-generated r and omisation sequence , we r and omly assigned patients with HCV genotype-1 to one of three cohorts ( A , B , and C ; in a 1:2:3 ratio ) , with r and omisation stratified by IL28B ( CC vs non-CC allele ) and HCV RNA ( < 800,000 IU/mL vs ≥800,000 IU/mL ) . Patients received sofosbuvir 400 mg plus peginterferon and ribavirin for 12 weeks ( cohort A ) or for 24 weeks ( cohort B ) , or 12 weeks of sofosbuvir plus peginterferon and ribavirin followed by 12 weeks of either sofosbuvir monotherapy or sofosbuvir plus ribavirin ( cohort C ) . We enrolled patients with all other eligible genotypes in cohort B. The primary efficacy endpoint was sustained virological response at post-treatment week 24 ( SVR24 ) by intention-to-treat analysis . This trial is registered with Clinical Trials.gov , number NCT01329978 . RESULTS We enrolled 316 patients with HCV genotype-1 : 52 to cohort A , 109 to cohort B , and 155 to cohort C. We assigned 11 patients with HCV genotype-4 and five patients with genotype-6 to cohort B ( we detected no patients with genotype 5 ) . In patients with HCVgenotype-1 , SVR24 was achieved by 46 patients ( 89 % , 95 % CI 77 - 96 ) in cohort A , 97 patients ( 89 % , 82 - 94 ) in cohort B , and by 135 ( 87 % , 81 - 92 ) in cohort C. We detected no difference in the proportion of patients achieving SVR24 in cohort A compared with cohort B ( p=0·94 ) , or in cohort C ( p=0·78 ) . Nine ( 82 % ) of 11 patients with genotype-4 and all five with genotype-6 achieved SVR24 . Seven patients , all with genotype-1 infection , relapsed after completion of assigned treatment . The most common adverse events that led to the discontinuation of any study drug -- anaemia and neutropenia -- were associated with peginterferon and ribavirin treatment . Three ( 6 % ) patients in cohort A , 18 ( 14 % ) patients in cohort B , and three ( 2 % ) patients in cohort C discontinued treatment because of an adverse event . INTERPRETATION Our findings suggest that sofosbuvir is well tolerated and that there is no additional benefit of extending treatment beyond 12 weeks , but these finding will have to be substantiated in phase 3 trials . These results lend support to the further assessment of a 12 week sofosbuvir regimen in a broader population of patients with chronic HCV genotype-1 infection , including those with cirrhosis . FUNDING Gilead Sciences Context Options are needed when initial therapy fails for hepatitis C virus ( HCV ) infection . Contribution In a phase 2 trial , treatment-experienced patients with genotype 3 HCV infection who either did not have cirrhosis or had compensated cirrhosis , as well as patients with genotype 1 HCV infection that was unsuccessfully treated with a protease inhibitor plus peginterferon or ribavirin , received sofosbuvir plus 1 of 2 doses of velpatasvir with or without ribavirin . Sustained virologic response rates 12 weeks after treatment were high in all groups that received sofosbuvir plus 100 mg of velpatasvir . Treatment was well-tolerated . Caution The number of patients was small . Implication Larger trials of sofosbuvir plus velpatasvir are indicated for patients with HCV infection for whom initial therapy fails . Of the 6 hepatitis C virus ( HCV ) genotypes , 1 and 3 are the most common and account for approximately 46 % and 22 % of all global infections , respectively ( 1 ) . Chronic infection with genotype 1 HCV is most prevalent in the Americas , Europe , and China , and genotype 3 HCV infection is most prevalent in India , Pakistan , and Southeast Asia ( 1 ) . With the advent of direct-acting antiviral agents , effective interferon-free combination regimens are now available for most patients chronically infected with genotype 1 or 3 HCV ( 2 , 3 ) . However , some subgroups of patients do not achieve optimal rates of sustained virologic response ( SVR ) with existing 12-week regimensin particular , cirrhotic patients with genotype 1 or 3 HCV infection who previously received unsuccessful treatment of HCV infection ( 46 ) . These patients , who are at increased risk for progression to decompensated cirrhosis , hepatocellular carcinoma , and other liver complications , have a medical need for more effective and well-tolerated treatment ( 7 , 8) . Velpatasvir ( Gilead Sciences ) is a novel inhibitor of the HCV NS5A protein , which is involved in HCV replication , virion assembly , and modulation of host cellular response . Velpatasvir ( formerly GS-5816 ) has demonstrated potent pangenotypic antiviral activity in vitro ( 9 ) and in a 3-day monotherapy study in patients with genotype 1 , 2 , 3 , or 4 HCV infection ( 10 , 11 ) . Pharmacology studies showed no clinical ly important drug interactions between sofosbuvir and velpatasvir ( 12 ) . A recent phase 2 study demonstrated the safety and efficacy of 12 weeks of the combination of sofosbuvir and velpatasvir in treatment-naive patients with genotype 1 to 6 HCV infection , with rates of SVR at week 12 after treatment ( SVR12 ) of 93 % to 100 % ( 13 ) . We evaluated the antiviral activity , safety , and tolerability of sofosbuvir administered with 25 or 100 mg of velpatasvir with and without ribavirin for 12 weeks in treatment-experienced patients with genotype 1 or 3 HCV infection . Because previously treated patients have historically had a poorer response than treatment-naive patients , we chose to evaluate sofosbuvir plus velpatasvir with ribavirin , as well as sofosbuvir plus velpatasvir alone . Methods Design Overview This phase 2 , multicenter , r and omized , open-label study was conducted from June 2013 ( when the first patient was enrolled ) to August 2014 ( when the last patient completed follow-up ) . The study was originally design ed to enroll 2 cohorts of patients with chronic genotype 3 HCV infection who had not achieved SVR after previous therapy with an interferon-based regimenapproximately 100 patients without cirrhosis and 100 patients with compensated cirrhosis . Favorable results in treatment-naive patients with genotype 1 HCV infection in a phase 2 trial of similar design ( 13 ) prompted us to amend our protocol to enroll a third cohort of approximately 100 patients with chronic genotype 1 HCV infection who did not achieve SVR after previous therapy with an approved or experimental NS3/4A protease inhibitor in combination with peginterferon and ribavirin . Up to 50 % of patients with genotype 1 HCV infection could have compensated cirrhosis . The protocol was approved by the institutional ethics committees at all sites , and the study was conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki . Setting and Participants The study was conducted at 58 clinical sites : 7 in Australia , 2 in New Zeal and , and 49 in the United States . Some patients were recruited partly through a posting of study details on Clinical Trials.gov and others through referral by their treating physicians . Adults ( aged 18 years ) with HCV RNA levels greater than 10000 IU/ \n Output:\n " }, { "from": "agent", "value": "In conclusion , the 12-week regimen of sofosbuvir plus velpatasvir was highly effective in HCV patients , including those with cirrhosis and former treatment experience .\nExcept for genotype-3 , adding ribavirin was not associated with significant improvements in SVR12 rates ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND AND PURPOSE The TEAM trial investigated the efficacy and safety of adjuvant endocrine therapy consisting of either exemestane or the sequence of tamoxifen followed by exemestane in postmenopausal hormone-sensitive breast cancer . The present analyses explored the association between locoregional therapy and recurrence ( LRR ) in this population . MATERIAL AND METHODS Between 2001 and 2006 , 9779 patients were r and omized . Local treatment was breast conserving surgery plus radiotherapy ( BCS+RT ) , mastectomy without radiotherapy ( MST-only ) , or mastectomy plus radiotherapy ( MST+RT ) . Patients with unknown data on surgery , radiotherapy , tumor or nodal stage ( n=199 ) , and patients treated by lumpectomy without radiotherapy ( n=349 ) were excluded . RESULTS After a median follow-up of 5.2 years , 270 LRRs occurred ( 2.9 % ) among 9231 patients . The 5-years actuarial incidence of LRR was 4.2 % ( 95 % CI 3.3 - 4.9 % ) for MST-only , 3.4 % ( 95 % CI 2.4 - 4.2 % ) for MST+RT and 1.9 % ( 95 % CI 1.5 - 2.3 % ) for BCS+RT . After adjustment for prognostic factors , the hazard ratio ( HR , reference BCS+RT ) for LRR remained significantly higher for MST-only ( HR 1.53 ; 95 % CI 1.10 - 2.11 ) , not for MST+RT ( HR 0.78 ; 95 % CI 0.50 - 1.22 ) . CONCLUSION This explorative analysis showed a higher LRR risk after MST-only than after BCS+RT , even after adjustment for prognostic factors . As this effect was not seen for MST+RT versus BCS+RT , it might be explained by the beneficial effects of radiation treatment Introduction This study had three aims : to establish the incidence of ipsilateral breast tumour recurrence ( IBTR ) in a community treatment setting , to evaluate known factors – in particular younger age ( < 40 years ) – predictive for local recurrence , and to assess the impact of local recurrence on disease-specific survival ( DSS ) . Methods A consecutive series of 1,540 women with node-negative breast cancer , diagnosed between the ages of 18–75 years , were prospect ively accrued between September 1987 and September 1999 . All had undergone a resection of the primary breast cancer with clear margins , an axillary lymph node dissection with a minimum of four sample d nodes , and breast-conserving surgery ( of any type ) . Results During the study follow-up period , 98 ( 6.4 % ) IBTRs and 117 ( 7.6 % ) deaths from or with breast cancer were observed . The median time to IBTR was 3.1 years and to death from or with disease was 4.3 years . In the multivariate Cox proportional hazards ( PH ) regression model for IBTR with adjuvant therapy factors , independent risk factors included age < 40 years ( relative risk ( RR ) = 1.89 , 95 % confidence interval ( CI ) of 1.00 – 3.58 ) , presence of intraductal disease ( RR = 1.81 , 95 % CI = 1.15–2.85 ) and histological grade ( ' G2 ' or G3 versus G1 : RR = 1.59 , 95 % CI = 0.87–2.94 ) . In the multivariate Cox PH regression model for DSS with adjuvant therapy factors , independent risk factors included previous IBTR ( RR = 2.58 , 95 % CI = 1.41–4.72 ) , tumor size ( 1–2 cm versus < 1 cm : RR = 1.95 , 95 % CI = 1.05–3.64 , > 2 cm versus < 1 cm : RR = 2.94 , 95 % CI = 1.56–5.56 ) , progesterone receptor status ( negative or equivocal versus positive or unknown : RR = 2.15 , 95 % CI = 1.36–3.39 ) , lymphatic invasion ( RR = 1.78 , 95 % CI = 1.17–2.72 ) , and histological grade ( ' G2 ' or G3 versus G1 : RR = 8.59 , 95 % CI = 2.09–35.36 ) . The effects of competing risks could be ignored . Conclusion The Cox PH analyses confirmed the importance of known risk factors for IBTR and DSS in a community treatment setting . This study also revealed that the early occurrence of an IBTR is associated with a relatively poor five-year survival rate Abstract Objectives Breast-conserving therapy ( BCT ) , including postoperative whole breast irradiation ( WBI ) , is generally accepted as the treatment of choice for most patients with early-stage breast cancer . The question whether WBI is m and atory in all patients remains one of the most controversial issues in BCT . To answer this question , a r and omized , prospect i ve , multicentre study was launched in January 2001 . Primary endpoints of the study were to assess the cumulative incidence of in-breast-recurrences ( IBR ) and overall survival ( OAS ) after conservative surgery ( BCS ) with or without WBI . Methods From January 2001 until December 2005 , 749 patients with unifocal infiltrating breast cancer up to 25 mm , 0–3 positive axillary lymph nodes , no extensive intraductal component or lymphvascular invasion from 11 centres in Italy , were r and omly assigned to BCS+WBI ( arm 1:373 patients ) or BCS alone ( arm 2:376 patients ) . Treatment arms were well balanced in terms of baseline characteristics . Systemic adjuvant therapy was administered according to the institutional policies . Kaplan – Meier method was used for survival analysis and log-rank test to evaluate the difference between the two arms . Results ( Last Analysis 31.12.2012)After median follow-up of 108 months , 12 ( 3.4 % ) IBR were observed in arm 1 and 16 ( 4.4 % ) in arm 2 . OAS was 81.4 % in arm 1 and 83.7 % in arm 2 . There was no statistically significant difference regarding IBR and death in the two treatment groups . Conclusions These data are promising and suggest that WBI after BCS can be omitted in selected patients with early stage breast cancer without exposing them to an increased risk of local recurrence and death . Longer follow-up is needed to further consoli date these results Purpose All Dutch hospitals are obliged to report their 5-year ipsilateral breast tumor recurrence ( IBTR ) rate after breast cancer surgery . Experts decided that these rates should not exceed 5 % . This study determined the value of IBTR as an indicator to compare quality of care between hospitals . Methods All patients with breast cancer ( pT1–3 , any N , M0 ) who underwent surgery in 1 of 92 Dutch hospitals from 2003 to 2006 were identified in the Netherl and s Cancer Registry . Data of recurrence was retrieved from hospital records . Five-year IBTR rates for breast-conserving surgery ( BCS ) and mastectomy were calculated by using the Kaplan – Meier method . Hospital variation was presented in funnel plots . Multivariate analysis was used to assess hospital characteristics associated with IBTR rates . Results A total of 40,892 breast cancer patients were included . The overall 5-year IBTR rate was 2.85 % ( 95 % confidence interval 2.68–3.03 ) and was significantly lower for BCS than for mastectomy ( 2.38 vs. 3.45 % , p < 0.001 ) . IBTR rates decreased over time in both groups . Rates varied between 0.77 and 5.70 % between hospitals . When r and om variation is taken into account , only extremely high IBTR rates can be detected as deviant from the target value of 5 % . Adjusting for tumor and patient characteristics , analyses showed that a higher volume of mastectomies is associated with lower IBTR rates . Conclusions Our population -based findings show that IBTR rates in the Netherl and s are low and have improved over time . The 5-year IBTR rate as an indicator for quality of care of individual hospitals is of limited value PURPOSE Postmastectomy radiotherapy ( RT ) in high-risk breast cancer patients can reduce locoregional recurrences ( LRRs ) and improve disease-free and overall survival . The aim of this analysis was to examine the overall disease recurrence pattern among patients r and omly assigned to receive treatment with or without RT . PATIENTS AND METHODS A long-term follow-up was performed among the 3,083 patients from the Danish Breast Cancer Cooperative Group 82 b and c trials , except in those already recorded with distant metastases ( DM ) or contralateral breast cancer ( CBC ) . The end points were LRR , DM , and CBC , and the follow-up continued until DM , CBC , emigration , or death . Information was selected from medical records , general practitioners , and the National Causes of Death Registry . The median potential follow-up time was 18 years . RESULTS The 18-year probability of any first breast cancer event was 73 % and 59 % ( P < .001 ) after no RT and RT , respectively ( relative risk [ RR ] , 0.68 ; 95 % CI , 0.63 to 0.75 ) . The 18-year probability of LRR ( with or without DM ) was 49 % and 14 % ( P < .001 ) after no RT and RT , respectively ( RR , 0.23 ; 95 % CI , 0.19 to 0.27 ) . The 18-year probability of DM subsequent to LRR was 35 % and 6 % ( P < .001 ) after no RT and RT , respectively ( RR , 0.15 ; 95 % CI , 0.11 to 0.20 ) , whereas the probability of any DM was 64 % and 53 % ( P < .001 ) after no RT versus RT , respectively ( RR , 0.78 ; 95 % CI , 0.71 to 0.86 ) . CONCLUSION Postmastectomy RT changes the disease recurrence pattern in high-risk breast cancer patients ; fewer patients have LRR as first site of recurrence , and overall fewer patients have DM BACKGROUND The EORTC 10801 trial compared breast-conserving therapy ( BCT ) with modified radical mastectomy ( MRM ) in patients with tumours 5 cm or smaller and axillary node negative or positive disease . Compared with BCT , MRM result ed in better local control , but did not affect overall survival or time to distant metastases . We report 20-year follow-up results . METHODS The EORTC 10801 trial was open for accrual between 1980 and 1986 in eight centres in the UK , the Netherl and s , Belgium , and South Africa . 448 patients were r and omised to BCT and 420 to MRM . R and omisation was done central ly , stratifying patients by institute , carcinoma stage ( I or II ) , and menopausal status . BCT comprised of lumpectomy and complete axillary clearance , followed by breast radiotherapy and a tumour-bed boost . The primary endpoint was time to distant metastasis . This analysis was done on all eligible patients , as they were r and omised . FINDINGS After a median follow-up of 22·1 years ( IQR 18·5 - 23·8 ) , 175 patients ( 42 % ) had distant metastases in the MRM group versus 207 ( 46 % ) in the BCT group . Furthermore , 506 patients ( 58 % ) died ( 232 [ 55 % ] in the MRM group and 274 [ 61 % ] in the BCT group ) . No significant difference was observed between BCT and MRM for time to distant metastases ( hazard ratio 1·13 , 95 % CI 0·92 - 1·38 ; p=0·23 ) or for time to death ( 1·11 , 0·94 - 1·33 ; 0·23 ) . Cumulative incidence of distant metastases at 20 years was 42·6 % ( 95 % CI 37·8 - 47·5 ) in the MRM group and 46·9 % ( 42·2 - 51·6 ) in the BCT group . 20-year overall survival was estimated to be 44·5 % ( 95 % CI 39·3 - 49·5 ) in the MRM group and 39·1 % ( 34·4 - 43·9 ) in the BCT group . There was no difference between the groups in time to distant metastases or overall survival by age ( time to distant metastases : < 50 years 1·09 [ 95 % CI 0·79 - 1·51 ] vs ≥50 years 1·16 [ 0·90 - 1·50 ] ; overall survival < 50 years 1·17 [ 0·86 - 1·59 ] vs ≥50 years 1·10 [ 0·89 - 1·37 ] ) . INTERPRETATION BCT , including radiotherapy , offered as st and ard care to patients with early breast cancer seems \n Output:\n " }, { "from": "agent", "value": "The presented rates are therefore the best available estimates of isolated IBTR and CBC annual incidence rates based on the current literature ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Approximately 10%–15 % of people with diabetes develop at least one foot ulcer during their lifetime . Treatment of diabetic foot ulcers ( DFUs ) represents a significant economic burden . Enzymatic debridement with clostridial collagenase ointment ( CCO ) can be used to remove necrotic tissue from wounds . This study examined the impact of CCO as an effective adjunct therapy to serial sharp debridement ( SSD ) and assessed the cost-effectiveness of CCO compared with st and ard DFU treatments over 1 year . Methods Adults 18 years or older with a diagnosis of type 1 or type 2 diabetes who had a neuropathic DFU were enrolled in a 12-week , r and omized , open-label trial . Patients were r and omly assigned to either treatment with CCO + SSD or to investigator-selected supportive care + SSD ( Control ) . A 3-state Markov model with a 1-week cycle length was developed using wound-closure rates from the trial to estimate the number of healed-wound weeks and the expected DFU cost per patient . The 3 states included unhealed , healed , and death . Results were extrapolated to 1 year to estimate the number of healed-wound weeks per treatment and the average cost to achieve epithelialization . The perspective of the analysis was that of the payer , specifically , the third party payer . Results The study sample included 55 patients ( 28 in CCO group ; 27 Control ) . The majority were men ( 74.5 % ) with a mean age of 57.9 years . Projected healing rates were greater for the CCO + SSD group compared to Control ( 89 % vs. 80 % , respectively ) . The expected number of epithelialized weeks accumulated over 1 year was 25 % greater in the CCO + SSD group than for Control ( 35 vs. 28 weeks , respectively ) . Over a 1-year time horizon , the expected cost per DFU was greater in the Control group than the CCO group ( $ 2,376 vs. $ 2,099 , respectively ) . The estimated cost per ulcer-free week was 40 % higher for Control ( $ 85/closed-wound week ) than for CCO + SSD ( $ 61/closed-wound week ) . Conclusions CCO + SSD therapy is a cost-effective method of debridement in the management of patients with DFUs , providing better outcomes at a lower cost . Further high quality trials are needed to confirm this finding . Trial registration This study was registered at Clinical Trials.gov as NCT01408277 BACKGROUND Despite significant advances , the treatment of diabetic foot ulcers ( DFUs ) remains a major therapeutic challenge for clinicians , surgeons , and other health care professionals . There is an urgent need for new strategies with clinical ly effective interventions to treat DFUs to reduce the burden of care in an efficient and cost-effective way . OBJECTIVE This r and omized trial evaluated and compared the clinical effectiveness , tolerability , and costs of clostridial collagenase ointment ( CCO ) debridement to that of debridement using saline moistened gauze ( SMG ) and selective sharp debridement for the treatment of DFUs . METHODS R and omized , controlled , parallel group , multicenter , open-label , 12-week study of 48 patients with neuropathic DFUs r and omized to 4 weeks of treatment with either CCO or SMG after baseline surgical debridement . The primary end point was the condition of the ulcer bed at the end of treatment as measured using a st and ardized wound assessment tool . Secondary end points were the percentage of reduction in wound area and therapeutic response rates . Adverse events were monitored for the tolerability analysis . In addition , a comparative cost-effectiveness analysis was performed from the perspective of the Centers for Medicare and Medicaid Services as a payer . RESULTS Both the CCO and SMG groups had significantly improved wound assessment scores after 4 weeks of treatment ( CCO , -2.5 , P = 0.007 ; SMG , -3.4 , P = 0.006 ) . Only CCO treatment result ed in a statistically significant decrease from baseline in the mean wound area at the end of treatment ( P = 0.0164 ) and at the end of follow-up ( P = 0.012 ) . In addition , the CCO group exhibited a significantly better response rate at the end of follow-up compared with the SMG group ( 0.92 vs 0.75 , P < 0.05 ) . Reported adverse events were similar between the 2 treatment groups . None of the reported adverse events were considered to be related to treatment . The economic analysis indicated that the direct mean costs per responder in the physician office setting of care were $ 832 versus $ 1042 for the CCO group versus the SMG group , whereas the direct mean costs per responder in the hospital outpatient department setting were $ 1607 versus $ 1980 . CONCLUSIONS CCO treatment provides equivalent debridement of DFUs similar to SMG while fostering better progress toward healing as measured by decreasing wound area over time and improved response rates at the end of follow-up . In addition , CCO yields a more favorable cost-effectiveness ratio in both the physician office and hospital outpatient department setting s of care . Clinical Trials.gov identifier : NCT01056198 INTRODUCTION The purpose of this study is to determine the cost-effectiveness of collagenase ointment relative to autolysis with a hydrogel dressing when debriding necrotic pressure ulcers in a long-term care setting . METHODS A Markov decision process model with 2 states ( necrotic nonviable wound bed transitioning to a granulated viable wound bed ) was developed using data derived from a prospect i ve , r and omized , 6-week , single-center trial of 27 institutionalized subjects with pressure ulcers that were ≥ 85 % necrotic nonviable tissue . Direct medical costs from the payer perspective included study treatments , wound treatment supplies , and nursing time . Clinical benefit was measured as \" granulation days \" and was derived from the time-dependent debridement rates of the alternative products . RESULTS The average cost per patient for 42 days of pressure ulcer care was $ 1,817 in 2012 for the collagenase group and $ 1,611 for the hydrogel group . Days spent with a granulated wound were 3.6 times higher for collagenase ( 23.4 vs 6.5 ) than with the hydrogel . The estimated cost per granulation day was > 3.2 times higher for hydrogel ( $ 249 ) vs collagenase ( $ 78 ) . CONCLUSIONS In this economic analysis based on a r and omized , controlled clinical trial , collagenase ointment result ed in a faster time to complete debridement and was more cost-effective than hydrogel autolysis for pressure ulcers in a long-term care setting . Even though collagenase ointment has a higher acquisition cost than hydrogel , the clinical benefit offsets the initial cost difference , result ing in lower cost per granulation day to the nursing home over the course of the 42-day analysis UNLABELLED  The role of maintenance debridement in wound healing has been well described , yet little is known regarding comparative methods and associated outcomes with this process when using collagenase or hydrogel . OBJECTIVE Evaluation of maintenance debridement and wound closure with collagenase compared to hydrogel in institutionalized adults with pressure ulcers from time of necrotic tissue removal up to 84 days from enrollment . METHODS This second phase of a rollover evaluation enrolled only subjects who successfully completed phase 1 ( previously reported ) from time of necrotic tissue debridement . Subjects received daily dressing changes with either hydrogel or collagenase followed by a st and ard semiocclusive dressing to evaluate wound-healing parameters and wound closure from initial enrollment to day 84 . Investigators blinded to r and omization evaluated weekly wound photographs using a digital planimetry software package for wound-healing parameters . Additionally , Pressure Ulcer Scale for Healing ( PUSH ) © Tool and wound bed scores ( WBS ) were monitored . RESULTS Eleven of 13 subjects from the collagenase group entered into phase 2 , with 4 of the 14 subjects from the hydrogel group . One subject from each group was eliminated within the first week of phase 2 . All subjects ( n = 3 ) in the hydrogel group reached complete epithelialization with a mean of 32.6 days . Nine of 10 subjects in the collagenase group reached completed epithelialization with a mean of 45 days . An independent sample s t test showed no statistical significance between the 2 groups ( P = 0.121 ) in days to healing . A Fisher 's exact test performed on the primary endpoint of complete epithelialization also demonstrated no significant difference in outcomes between the groups ( P = 0.99 ) . Mean WBS at the onsetof phase 2 was 13.7 ( range 12 - 16 ) , and the PUSH Tool mean score was 1.0 ( range 0 - 3 ) . In aggregating phase 1 and phase 2 data , a difference in the closure rates at the end of the study , 69 % ( collagenase ) vs 21 % ( hydrogel ) , was statically significant ( P = 0.0213 ) using a Fisher 's exact test . CONCLUSION Facilitating maintenance debridement by either collagenase or hydrogel can be used to complete wound closure when used in conjunction with a vali date d predictive wound-healing tool that closely monitors therapy . This study showed statistical significance in favor of collagenase when evaluating closure rates from the onset of the pressure ulcer . OBJECTIVE A r and omised clinical trial ( n = 42 ) compared the effectiveness of two approaches to debriding chronic leg ulcers : TenderWet 24 , which is design ed to support the autolytic degradation process , and Iruxol N ( Santyl ) , an enzymatic treatment cl aim ed to enhance the degradation process . METHOD Patients were r and omly assigned to one of the two treatment groups for three weeks . Wounds were evaluated weekly for the amount of eschar/slough , the area of healthy granulation and the re-epithelialised area . RESULTS During days 1 - 14 slough within the groups was reduced by almost 19 % for TenderWet 24 and by 9 % for Iruxol N , followed by an increase of 26 % and 10 % respectively in granulation tissue . These effects were less accentuated during days 7 - 21 . There was a further 11 % improvement in tissue debridement for the TenderWet 24 group and a relapse ( + 9.1 % ) in the Iruxol N group . CONCLUSION Although TenderWet 24 appeared to be more efficient in a few cases , the general efficacy of the two products appeared to be almost the same as no statistically significant superiority of either product was found UNLABELLED  Comparisons of collagenase to other methods of debridement , including wet to dry dressings , have been reported in the literature ; however , studies comparing collagenase to hydrogel have not been reported . OBJECTIVE Time to complete necrotic tissue debridement with collagenase compared to hydrogel in institutionalized adults with pressure ulcers . METHODS R and omization occurred after obtaining informed consent to avoid selection bias . Subjects received daily dressing changes with either hydrogel or collagenase followed by a st and ard semi-occlusive dressing to evaluate time to debridement up to Day 42 . Investigators , who were blinded to r and omization , evaluated weekly wound photographs for necrotic tissue debridement and wound healing parameters using a digital planimetry software package . Nonviable tissue was not cross-hatched in either group . RESULTS Twenty-seven nursing home residents were enrolled over a period of 1 year . According to a Student 's t test , there were no significant differences between groups for age , gender , age of wound , or percentage of nonviable tissue at the time of enrollment ( P = .03 ) . Using a Pearson Chi square analysis , the collagenase group was found to have statistical ( P = .003 ) significance in achieving full debridement by Day 42 . CONCLUSION This study showed statistical significance in favor of collagenase when used to debride nonviable tissue in pressure ulcers . Despite recommendations to cross-hatch eschar , statistical significance was still achieved when wounds were not cross-hatched , indicating clinical utility in setting s without clinician availability for the cross-hatching procedure During burn care the wounds must be repeatedly debrided of adherent and loose debris until the decision is made to surgically excise and graft the wound or to await epithelialization . Though native proteolytic enzymes in the skin or those produced by colonizing bacteria can speed eschar separation , the use of exogenous enzymes for wound debridement may accelerate wound cleaning and healing . Collagenase digests native and denatured collagen in necrotic tissue . This multicenter trial of 79 patients with partial-thickness wounds compared the efficacy of collagenase ointment applied with polymyxin B sulfate/bacitracin powder with the efficacy of st and ard topical antimicrobial therapy ( control ) in which silver sulfadiazine cream ( 1 % ) was used to debride paired burn sites . Patients selected for the study had two noncontiguous , partial-thickness , comparably sized , and anatomically similar burn wounds . Ages of patients ranged from 5 to 60 years ( mean 33 years ) . The total body surface area burned ranged from 2 % to 30 % ( mean 13.6 % ) . Mean burn sizes used for study treatment were 366 cm2 ( 26 to 2310 cm2 ) for col \n Output:\n " }, { "from": "agent", "value": "Results support the use of collagenase for enzymatic debridement in pressure ulcers , diabetic foot ulcers and in conjunction with topical antibiotics for burns ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Optimal management of patients with relapsed/refractory chronic lymphocytic leukemia ( CLL ) is dictated by patient characteristics , prior therapy , and response to prior therapy . We report the final analysis of combined fludarabine , cyclophosphamide , and rituximab ( FCR ) for previously treated patients with CLL and identify patients who benefit most from this therapy . We explore efficacy of FCR in patients beyond first relapse , patients with prior exposure to fludarabine and alkylating agent combinations , and patients with prior exposure to rituximab . The FCR regimen was administered to 284 previously treated patients with CLL . Patients were assessed for response and progression by 1996 National Cancer Institute-Working Group ( NCI-WG ) criteria for CLL and followed for survival . The overall response rate was 74 % , with 30 % complete remission . The estimated median overall survival was 47 months and median progression-free survival for all patients was 21 months . Subgroup analyses indicated that the following patients were most suitable for FCR treatment : patients with up to 3 prior treatments , fludarabine-sensitive patients irrespective of prior rituximab exposure , and patients without chromosome 17 abnormalities . FCR is an active and well-tolerated therapy for patients with relapsed CLL . The addition of rituximab to FC improved quality and durability of response in this patient population Background The efficacy and safety of adding rituximab to fludarabine and cyclophosphamide ( R-FC ) for the treatment of chronic lymphocytic leukaemia ( CLL ) has been demonstrated in two r and omised trials : CLL-8 was conducted in previously untreated patients , and REACH was conducted in previously treated patients . In both trials , progression-free survival was increased in the R-FC treatment groups compared with the FC treatment groups . In CLL-8 , overall survival was also significantly increased . Objective To develop an economic model to assess the cost effectiveness , from the Australian healthcare perspective , of rituximab when used as a treatment for both previously untreated and relapsed/refractory CLL . Methods A Markov model with three health states ( unprogressed , progressed and death ) was developed to extrapolate the trial results over a 15-year time horizon . A treatment algorithm was developed with Australian haematologists to inform the treatments to be modelled . The base-case compares up to three courses of six cycles of R-FC ( ‘ first-line ’ treatment ) followed by three courses of post-progression salvage ( ‘ Salvage ’ ) treatment ( including rituximab ) with three courses of FC followed by three courses of Salvage treatment ( excluding rituximab ) . Subsequent treatments are incorporated into the model by repeating the unprogressed and progressed health states for each treatment . Time-dependent transition probabilities for the model were estimated from an analysis of individual patient data from CLL-8 and REACH . Comparisons of the hazard rates for the CLL-8 and REACH trials enabled an assessment of the impact on the transitions of receiving the same regimen as the first or second treatment , and hence inform assumptions regarding transitions for third and subsequent treatments . Costs applied in the model were based on published Australian prices in 2009 . Results The model predicts patients receive an average of approximately two courses of treatment , and the addition of rituximab results in an incremental gain of 0.94 quality -adjusted life-years ( QALYs ) . The incremental cost associated with the addition of rituximab is A$ 40,268 , and hence the cost per QALY gained ( QALYG ) is A$ 42,906 . Conclusion Rituximab , in combination with chemotherapy , when used multiple times throughout the treatment algorithm , appears to be cost effective for CLL from the Australian healthcare perspective , with a cost/QALYG within the range generally accepted as providing value BACKGROUND The monoclonal anti-CD20 antibody rituximab , combined with chemotherapeutic agents , has been shown to prolong overall survival in physically fit patients with previously untreated chronic lymphocytic leukemia ( CLL ) but not in those with coexisting conditions . We investigated the benefit of the type 2 , glycoengineered antibody obinutuzumab ( also known as GA101 ) as compared with that of rituximab , each combined with chlorambucil , in patients with previously untreated CLL and coexisting conditions . METHODS We r and omly assigned 781 patients with previously untreated CLL and a score higher than 6 on the Cumulative Illness Rating Scale ( CIRS ) ( range , 0 to 56 , with higher scores indicating worse health status ) or an estimated creatinine clearance of 30 to 69 ml per minute to receive chlorambucil , obinutuzumab plus chlorambucil , or rituximab plus chlorambucil . The primary end point was investigator-assessed progression-free survival . RESULTS The patients had a median age of 73 years , creatinine clearance of 62 ml per minute , and CIRS score of 8 at baseline . Treatment with obinutuzumab-chlorambucil or rituximab-chlorambucil , as compared with chlorambucil monotherapy , increased response rates and prolonged progression-free survival ( median progression-free survival , 26.7 months with obinutuzumab-chlorambucil vs. 11.1 months with chlorambucil alone ; hazard ratio for progression or death , 0.18 ; 95 % confidence interval [ CI ] , 0.13 to 0.24 ; P<0.001 ; and 16.3 months with rituximab-chlorambucil vs. 11.1 months with chlorambucil alone ; hazard ratio , 0.44 ; 95 % CI , 0.34 to 0.57 ; P<0.001 ) . Treatment with obinutuzumab-chlorambucil , as compared with chlorambucil alone , prolonged overall survival ( hazard ratio for death , 0.41 ; 95 % CI , 0.23 to 0.74 ; P=0.002 ) . Treatment with obinutuzumab-chlorambucil , as compared with rituximab-chlorambucil , result ed in prolongation of progression-free survival ( hazard ratio , 0.39 ; 95 % CI , 0.31 to 0.49 ; P<0.001 ) and higher rates of complete response ( 20.7 % vs. 7.0 % ) and molecular response . Infusion-related reactions and neutropenia were more common with obinutuzumab-chlorambucil than with rituximab-chlorambucil , but the risk of infection was not increased . CONCLUSIONS Combining an anti-CD20 antibody with chemotherapy improved outcomes in patients with CLL and coexisting conditions . In this patient population , obinutuzumab was superior to rituximab when each was combined with chlorambucil . ( Funded by F. Hoffmann-La Roche ; Clinical Trials.gov number , NCT01010061 . ) Chronic lymphocytic leukemia ( CLL ) has an extremely heterogeneous prognosis . Nowadays , the median survival of patients with this form of leukemia is 8–10 years , compared with 5–6 years in series reported in the 1970s . This is largely due to the higher number of patients who are now being diagnosed in early phase ( up to 80 % ) and , hence , with better prognosis [ 1 , 2 ] . Individual survival , however , is highly variable . Classically , clinical stages have been used to predict the behavior of the disease [ 3 , 4 ] . Although easy to apply and reproducible ( a necessary condition for any prognostic factor to be accepted as such ) , staging systems have some weaknesses . For example , the mechanisms accounting for cytopenias ( i.e. bone marrow infiltration , hypersplenism , autoimmune basis ) are not taken into consideration . As a result , patients are classified as being in advanced stage independently of the origin of the anemia or thrombocytopenia . Yet there is some indication that the mechanism of the cytopenia is also a factor in prognosis [ 5 ] . Even more important is the prognostic heterogeneity within each of the clinical stages . Thus , staging systems do not allow identification of individuals in early stage who are likely to progress and those in whom the disease will have an indolent course . This is important , since patients in early stage who are likely to progress might benefit from being treated immediately after diagnosis , before progression occurs , and also because of the uncertainty of the prognosis in individuals otherwise in good clinical condition in whom the diagnosis has been made on a routine medical examination . Conversely , some patients presenting in advanced stage run an indolent course and for long periods of time may not require therapy ; the staging systems do not identify these patients either . All this is essentially due to the fact that clinical stages are a mere reflection of the biological diversity of the disease [ 6 , 7 ] . Such heterogeneity , fortunately , is rapidly unfolding . For example , cytogenetic abnormalities , as studied by fluorescence in situ hybridization , can be detected in up to 90 % of the patients . Although they are not specific , there are interesting correlates between some cytogenetic aberrations and clinical features . Thus , patients with del(13q ) as sole abnormality have good prognosis ; in contrast , those with del(11q ) or del(17p ) tend to have a rapidly evolving disease and do not respond to treatment . Furthermore , trisomy 12 is associated with atypical morphology and immunophenotype , and del(6q ) may be observed more frequently in cases with plasmacytoid features [ 8–11 ] . On the other h and , CLL has long been considered a homogeneous disease of naı̈ve CD5 + B cells , pre-germinal cells not exposed to antigenic stimulation . In 1999 , two different groups made an important breakthrough in the underst and ing of CLL by showing that , whereas in some cases IgVH genes are unmutated , in others they are [ 12 , 13 ] . Since somatic mutation takes place in the germinal center of lymphoid follicles , CLL can be a tumor of either preor post-germinalcenter B cells . These two forms , however , share the same genetic signature as determined by microarrays and , because of this , CLL is considered to be a single disease with two variants ( i.e. mutated and unmutated ) [ 14 ] . The mutational status of IgVH genes separates CLL into two forms with distinct presenting features and outcome . Compared with those with IgVH mutations , patients with unmutated IgVH genes have a more malignant disease , including advanced stage , atypical cell morphology , adverse cytogenetic features and resistance to therapy [ 12 , 13 ] . Unfortunately , study ing IgVH mutations on a routine basis is not yet easy . CD38 expression correlates , although not absolutely , with IgVH mutations ; in addition , CD38 expression may vary over time [ 15 ] . Recently , it has been demonstrated that ZAP-70 expression , as evaluated by cytofluorometry or PCR , correlates strongly with IgVH mutations and has important prognostic significance by itself [ 16–19 ] . Of great importance , these new biological prognostic parameters have independent prognostic value and discriminate , among patients in early clinical stage , those who are likely to progress and those who will remain stable . As the mysteries of the biology of CLL are revealed , important biological prognostic parameters are cl aim ing a place in the prognostic assessment of the disease . The staging systems developed in the early 1970s have been crucial in the progress of our underst and ing on CLL . Because of their simplicity and reproducibility they have been widely employed . They have also been critical in conducting r and omized treatment studies in comparable series of patients , and in attracting the interest of a new generation of younger physicians and investigators to an old disease . To ab and on the clinical staging systems would be not only precipitous , but unwise . Rather than replace clinical stages and other simple prognostic parameters ( e.g. degree of bone marrow infiltration , white blood cell count , doubling time ) , these new factors should currently be employed to refine the prognostic power of classical prognostic factors . Finally , clinical staging systems and other prognostic factors were developed in an era in which no effective therapy existed for CLL . Since prognostic indicators may change as more effective therapies become available , prognosis should be assessed prospect ively in patients treated with the newer and more effective therapies . Only in that manner will the most relevant prognostic factors for CLL eventually be identified , a quarter of a century after the introduction of clinical stages . Annals of Oncology 15 : 1450–1451 , 2004 Early results of the fludarabine , cyclophosphamide , and rituximab ( FCR ) regimen in 224 patients showed that it was highly active as initial therapy of chronic lymphocytic leukemia . In this report , we present the final results of all 300 study patients at a median follow up of 6 years . The overall response rate was 95 % , with complete remission in 72 % , nodular partial remission in 10 % , partial remission due to cytopenia in 7 % , and partial remission due to residual disease in 6 % . Two patients ( < 1 % ) died within 3 months of starting therapy . Six-year overall and failure-free survival were 77 % and 51 % , respectively . Median time to progression was 80 months . Pretreatment characteristics independently associated with inferior response were age 70 years or older , beta2-microglobulin twice the upper limit of normal ( 2N ) or more , white cell count 150 x 10(9)/L or more , abnormal chromosome 17 , \n Output:\n " }, { "from": "agent", "value": "While the cohort Markov approach has been acceptable to the National Institute for Health and Care Excellence , the review identifies a number of key uncertainties with these models , including the extrapolation of survival outcomes beyond the period observed by the trial , the effectiveness of second-line therapies , and estimates of health state utility ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objectives : To determine the effects of risk and payment on subjects ’ willingness to participate , and to examine how payment influences subjects ’ potential behaviours and risk evaluations . Methods : A 3 ( level of risk ) × 3 ( level of monetary payment ) , between subjects , completely r and omised factorial design was used . Students enrolled at one of five US pharmacy schools read a recruitment notice and informed consent form for a hypothetical study , and completed a question naire . Risk level was manipulated using recruitment notices and informed consent documents from hypothetical biomedical research projects . Payment levels were determined using the payment models evaluated by Dickert and Grady as a guide . Five dependent variables were assessed in the question naire : willingness to participate , willingness to participate with no payment , propensity to neglect to tell about restricted activities , propensity to neglect to tell about negative effects , and risk rating . Results : Monetary payment had positive effects on respondents ’ willingness to participate in research , regardless of the level of risk . However , higher monetary payments did not appear to blind respondents to the risks of a study . Payment had some influence on respondents ’ potential behaviours regarding concealing information about restricted activities . However , payment did not appear to have a significant effect on respondents ’ propensity to neglect to tell research ers about negative effects . Conclusions : Monetary payments appear to do what they are intended to do : make subjects more willing to participate in research . Concerns about payments blinding subjects to risks could not be substantiated in the present study . However , the findings do raise other concerns — notably the potential for payments to diminish the integrity of a study ’s findings . Future research is critical to make sound decisions about the payment of research subjects OBJECTIVE A feasibility study for a trial of strategies for the prevention of atherosclerosis in patients with systemic lupus erythematosus ( SLE ) was stopped because of inadequate recruitment . There is little underst and ing of the factors influencing patients ' decisions about participation in prevention trials . Our goal was to determine factors that patients with SLE consider in deciding about participating in prevention trials , to uncover concerns about SLE trials , and to investigate how study design and purpose affect participation decisions . METHODS We conducted focus groups with trial participants ( n = 13 ) , trial non participants ( n = 8) , and a group of patients with diabetes ( n = 9 ) . We conducted telephone interviews with SLE patients who refused participation in the trial and the focus groups ( n = 10 ) . A trained facilitator elicited factors influencing participation decisions . Transcripts were coded and grouped into themes using grounded theory . RESULTS Demographic characteristics of the groups were similar . Seven factors emerged as important in decision making : current health status , study design , physician involvement , personal benefit , altruism , time , and incentives . These factors were considered by individuals who elected to participate and those who did not , but weighed differently . Among the trial participants , good health status , encouragement from one 's physician , and desires to learn and to contribute stimulated participation . Reasons for nonparticipation included current health status , medication and r and omization concerns , and personal factors . CONCLUSION We observed that similar factors were weighed differently by participants and non participants . Our results suggest that strategies such as health education , enlistment of personal physicians , and limitation of time requirements may enhance recruitment of patients with SLE into clinical prevention trials One of the most influential factors in science and medicine has been the development of placebo-controlled clinical trials . However , recruitment of patients for clinical trials is sometimes a major problem in clinical research . Successful patient recruitment may be enhanced with a clear underst and ing of the motivating factors that determine a patient 's decision to enter a study . We have developed the Patients ' Expectations , Attitudes and Knowledge ( PEAK ) Program consisting of question naires design ed to study the factors motivating patients to enter a clinical trial , as well as capturing the experiences of research participants . A total of 247 female patients with dyspepsia ( mean age : 43.9 ; range : 18.0 - 78.0 years ) who entered either of two prospect i ve double-blind , r and omized , placebo-controlled multicenter trials in the USA completed PEAK Entry question naires during the first study visit . Based on their responses , the top three factors motivating patients to join the clinical trial were : interest in receiving investigational treatment with average score ( AS ) of 4.33 + /- 0.08 ( M + /- SEM ) on a 5-point scale , possibility of getting skilled professional care ( AS = 4.07 + /- 0.09 ) , and altruism expressed as an intention to help develop a new drug for the sake of other people ( AS = 3.89 + /- 0.09 ) . Age , ethnicity , and educational status significantly affected motivational factors of patients . These results indicate that recruitment can be enhanced by targeting these motivations in physician/patient communications , informed consent process and advertising for study participants OBJECTIVES Gender and ethnicity are factors affecting the incidence and severity of vascular disease as well as subsequent treatment outcomes . Although well studied in other fields , balanced enrollment of patients with relevant demographic characteristics in vascular surgery r and omized controlled trials ( RCTs ) is not well known . This study describes the reporting of gender and ethnicity data in vascular surgery RCTs and analyzes whether these studies adequately represent our diverse patient population . METHODS We conducted a retrospective review of United States-based RCTs from 1983 through 2007 for three broadly defined vascular procedures : aortic aneurysm repair ( AAR ) , carotid revascularization ( CR ) , and lower extremity revascularization ( LER ) . Included studies were examined for gender and ethnicity data , study parameters , funding source , and geographic region . The Nationwide Inpatient Sample ( NIS ) data base was analyzed to obtain group-specific procedure frequency as an estimate of procedure frequency in the general population . RESULTS We review ed 77 studies , and 52 met our inclusion criteria . Only 85 % reported gender , and 21 % reported ethnicity . Reporting of ethnicity was strongly associated with larger ( > 280 participants ) , multicenter , government-funded trials ( P < .001 for all ) . Women are disproportionately under-represented in RCTs for all procedure categories ( AAR , 9.0 % vs 21.5 % ; CR , 30.0 % vs 42.9 % ; LER , 22.4 % vs 41.3 % ) . Minorities are under-represented in AAR studies ( 6.0 % vs 10.7 % ) and CR studies ( 6.9 % vs 9.5 % ) but are over-represented in LER studies ( 26.0 % vs 21.8 % , P < .001 for all ) . CONCLUSIONS Minority ethnicity and female gender are under-reported and under-represented in vascular surgery RCTs , particularly in small , non-government-funded and single-center trials . The generalizability of some trial results may not be applicable to these population s. Greater effort to enroll a balanced study population in RCTs may yield more broadly applicable results The study objective was to assess willingness of men who have sex with men ( MSM ) enrollled in a vaccine preparedness study ( ' Projeto Rio ' ) to participate in phase III anti-HIV/AIDS vaccine trials . Overall , 57 % of Projeto Rio participants stated they would participate in a putative vaccine trial . MSM who reported commercial sex work were significantly ( p<0.05 ) more likely to engage in risky behaviours than others . In bivariate analysis , commercial sex workers ( CSWs ) were significantly ( p<0.05 ) more likely than non-commercial sex workers ( NCSWs ) to be willing to participate in vaccine trials ( 62.6 % versus 51.4 % ) . Among those willing , CSWs reported significantly more often ( p<0.05 ) ( 50.5 % ) than NCSWs ( 38.0 % ) that they would enroll to protect themselves from HIV . In multivariate analyses , variables associated with willingness to participate ( WTP ) were lower educational level , positive serology for syphilis , and ' engagement , under the influence of alcohol , in risky sexual practice s that would normally be avoided ' , but not commercial sex work . The potential enrollment in vaccine trials of MSM CWSs , as well as participants of low socio-economic status and high risk , seems thus to be possible Summary : Underst and ing why people join HIV vaccine efficacy trials is critical for trial recruitment and education efforts . We assessed participants ' motivations for joining the VaxGen VAX004 study , a r and omized , double-blind , placebo-controlled , phase 3 multicenter trial . Of 5417 participants , 94 % were men who have sex with men ( MSM ) and 6 % were women at risk for heterosexual transmission of HIV . Most participants gave altruistic reasons for trial participation : 99 % reported having joined to help find an HIV vaccine , and 98 % reported having joined to help their community . Some gave more personal reasons : 56 % joined to reduce risk behavior and 46 % joined to get protection from HIV . Additional reasons related to receiving services or compensation included to obtain information about HIV ( 75 % ) , to receive free HIV testing ( 34 % ) , and for financial reimbursement ( 14 % ) . Multivariate logistic regression analysis showed that female participants were significantly more motivated than male participants to join the trial for protection and to receive services or compensation ( all P < 0.05 ) . Participants with 13 or more sex partners in the 6 months before enrollment were more likely than those with fewer sex partners to report having joined the trial for protection but less likely to have joined to reduce risk behavior ( both P < 0.05 ) . Because many participants reported personal protection from HIV as their reason for joining , vaccine trial risk-reduction counseling should continue to emphasize the placebo-controlled trial design and unknown efficacy of the test product , particularly for women and persons with large numbers of sex partners . Because a significant minority of participants reported joining to receive HIV information , HIV testing , and financial reimbursement , a need is indicated for provision of HIV prevention services outside research trials and for monitoring to ensure that participants are not motivated to join trials for financial gain BACKGROUND Paying patients to participate in clinical trials is ethically controversial . However , there has been no empirical documentation regarding whether payment represents an undue or unjust inducement . METHODS To evaluate these questions , we described hypothetical placebo-controlled trials of a new antihypertensive drug to 126 patients with mild-to-moderate hypertension recruited from hypertension and general medicine clinics at a university hospital . Using a 3 x 3 , within-subjects design , we altered a risk to participation ( either adverse effect rate or rate of r and omization to placebo ) and the payment participants would receive ( $ 100 , $ 1000 , and $ 2000 ) and asked patients to indicate their willingness to participate ( WTP ) in each trial using a 6-point scale . RESULTS Clustered ordinal logistic regression models revealed that patients ' WTP decreased with higher risk of adverse effects ( P<.001 ) , higher risk of being assigned to placebo ( P = .02 ) , and lower payment level ( P<.001 ) . There were no significant interactions between payment level and either risk variable , suggesting that increasing payments do not alter peoples ' perceptions of risk . There was a trend toward a positive interaction between income and the influence of payment on WTP ( P = .09 ) , suggesting that payment more strongly influences WTP among wealthier people . Wealthier patients were more likely to state that payment was important in their participation decision ( 37 % vs 20 % , P = .05 ) . CONCLUSION Although higher payment motivates research participation , we found no evidence that commonly used payment levels represent undue or unjust inducements Injection drug users ( IDUs ) represent an important risk group for HIV infection . We assessed correlates of IDUs ' willingness to participate ( WTP ) in HIV vaccine trials , and examined temporal changes in WTP . Participants were enrolled in ALIVE , a prospect i ve study of HIV among IDUs in Baltimore ; semi-annual visits include interviews and HIV serology . Question naires regarding WTP were administered in 1993–1994 and again in 2001–2002 . Logistic regression was conducted to identify correlates of WTP . Wave 1 of the survey included 440 participants ; Wave 2 included 582 participants ( 189 participated in both waves ) . WTP increased modestly over time ( 83.4 vs. 86.3 % ; p = 0.16 ) . Monetary incentives were the strongest predictor of WTP ( adjOR = 2.73 ; 95 % CI : 1.72–4.35 ) . High expectations of HIV treatment effectiveness did not predict WTP . In this cohort , WTP remained strong and modestly increased over the study period . These results should be considered in the planning of sampling and retention strategies for future vaccine trials Objective : To evaluate the representation of minority groups in r and omized control trials ( RCTs ) , and the frequency with which this information is reported . Study Design : Review ers collected data on the racial/ethnic composition of study sample s from all RCTs published in six leading medical journals in 1999 . Results : Of the 280 RCTs , most ( 204 , 71.3 % ) provided no information on the race/ethnicity of participants . Of the 89 U.S.-based RCTs , 50 ( 56.1 % ) reported their minority distribution . Relative to other trials , those funded by the National Institute of Health ( NIH ) ( n = 52 ) were more likely to report race/ethnicity data ( 55. \n Output:\n " }, { "from": "agent", "value": "Our main findings are 1 ) the major motivation for Brazilian patients to participate in clinical trials is altruism , 2 ) monetary reimbursement is the least important factor motivating Brazilian patients , 3 ) the major barrier for Brazilian patients to not participate in clinical trials is the fear of side effects , and 4 ) Brazilian patients are more likely willing to participate in clinical trials than Indians ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE Insulin degludec ( IDeg ) is a basal insulin that forms soluble multihexamers after subcutaneous injection , result ing in an ultra-long action profile . We assessed the efficacy and safety of IDeg formulations administered once daily in combination with mealtime insulin aspart in people with type 1 diabetes . RESEARCH DESIGN AND METHODS In this 16-week , r and omized , open-label trial , participants ( mean : 45.8 years old , A1C 8.4 % , fasting plasma glucose [ FPG ] 9.9 mmol/L , BMI 26.9 kg/m2 ) received subcutaneous injections of IDeg(A ) ( 600 μmol/L ; n = 59 ) , IDeg(B ) ( 900 μmol/L ; n = 60 ) , or insulin glargine ( IGlar ; n = 59 ) , all given once daily in the evening . Insulin aspart was administered at mealtimes . RESULTS At 16 weeks , mean A1C was comparable for IDeg(A ) ( 7.8 ± 0.8 % ) , IDeg(B ) ( 8.0 ± 1.0 % ) , and IGlar ( 7.6 ± 0.8 % ) , as was FPG ( 8.3 ± 4.0 , 8.3 ± 2.8 , and 8.9 ± 3.5 mmol/L , respectively ) . Estimated mean rates of confirmed hypoglycemia were 28 % lower for IDeg(A ) compared with IGlar ( rate ratio [ RR ] : 0.72 [ 95 % CI 0.52–1.00 ] ) and 10 % lower for IDeg(B ) compared with IGlar ( RR : 0.90 [ 0.65–1.24 ] ) ; rates of nocturnal hypoglycemia were 58 % lower for IDeg(A ) ( RR : 0.42 [ 0.25–0.69 ] ) and 29 % lower for IDeg(B ) ( RR : 0.71 [ 0.44–1.16 ] ) . Mean total daily insulin dose was similar to baseline . The frequency and pattern of adverse events was similar between insulin treatments . CONCLUSIONS In this clinical exploratory phase 2 trial in people with type 1 diabetes , IDeg is safe and well tolerated and provides comparable glycemic control to IGlar at similar doses , with reduced rates of hypoglycemia BACKGROUND Intensive basal-bolus insulin therapy has been shown to improve glycaemic control and reduce the risk of long-term complications that are associated with type 1 diabetes mellitus . Insulin degludec is a new , ultra-longacting basal insulin . We therefore compared the efficacy and safety of insulin degludec and insulin glargine , both administered once daily with mealtime insulin aspart , in basal-bolus therapy for type 1 diabetes . METHODS In an open-label , treat-to-target , non-inferiority trial , undertaken at 79 sites ( hospitals and centres ) in six countries , adults ( aged ≥18 years ) with type 1 diabetes ( glycated haemoglobin [ HbA(1c ) ] ≤10 % [ 86 mmol/mol ] ) , who had been treated with basal-bolus insulin for at least 1 year , were r and omly assigned in a 3:1 ratio , with a computer-generated blocked allocation sequence , to insulin degludec or insulin glargine without stratification by use of a central interactive response system . The primary outcome was non-inferiority of degludec to glargine , assessed as a reduction in HbA(1c ) after 52 weeks , with the intention-to-treat analysis . This trial is registered with Clinical Trials.gov , number NCT00982228 . FINDINGS Of 629 participants , 472 were r and omly assigned to insulin degludec and 157 to insulin glargine ; all were analysed in their respective treatment groups . At 1 year , HbA(1c ) had fallen by 0·40 % points ( SE 0·03 ) and 0·39 % points ( 0·07 ) , respectively , with insulin degludec and insulin glargine ( estimated treatment difference -0·01 % points [ 95 % CI -0·14 to 0·11 ] ; p<0·0001 for non-inferiority testing ) and 188 ( 40 % ) and 67 ( 43 % ) participants achieved a target HbA(1c ) of less than 7 % ( < 53 mmol/mol ) . Rates of overall confirmed hypoglycaemia ( plasma glucose < 3·1 mmol/L or severe ) were similar in the insulin degludec and insulin glargine groups ( 42·54 vs 40·18 episodes per patient-year of exposure ; estimated rate ratio [ degludec to glargine ] 1·07 [ 0·89 to 1·28 ] ; p=0·48 ) . The rate of nocturnal confirmed hypoglycaemia was 25 % lower with degludec than with glargine ( 4·41 vs 5·86 episodes per patient-year of exposure ; 0·75 [ 0·59 to 0·96 ] ; p=0·021 ) . Overall serious adverse event rates ( 14 vs 16 events per 100 patient-years of exposure ) were similar for the insulin degludec and insulin glargine groups . INTERPRETATION Insulin degludec might be a useful basal insulin for patients with type 1 diabetes because it provides effective glycaemic control while lowering the risk of nocturnal hypoglycaemia , which is a major limitation of insulin therapy . FUNDING Novo Nordisk OBJECTIVE To evaluate efficacy and tolerability of a co-formulation of insulin degludec and insulin aspart ( IDegAsp ) with insulin aspart ( IAsp ) at other meals compared with basal-bolus therapy using insulin detemir ( IDet ) and IAsp . RESEARCH DESIGN AND METHODS Adults ( n = 548 ) with type 1 diabetes ( A1C 7.0–10.0 % ; BMI ≤35.0 kg/m2 ) were r and omized 2:1 in a 26-week , multinational , parallel-group , treat-to-target trial to IDegAsp or IDet . IDegAsp was given with a meal , and IDet was given in the evening , with a second ( breakfast ) dose added if needed . RESULTS Non-inferiority for IDegAsp versus IDet was confirmed ; A1C improved by 0.75 % with IDegAsp and 0.70 % with IDet to 7.6 % in both groups ( estimated treatment difference IDegAsp − IDet : –0.05 % [ 95 % CI –0.18 to 0.08 ] ) . There was no statistically significant difference between IDegAsp and IDet in the rates of severe hypoglycemia ( 0.33 and 0.42 episodes/patient-year , respectively ) or overall confirmed ( plasma glucose < 3.1 mmol/L ) hypoglycemia ( 39.17 and 44.34 episodes/patient-year , respectively ) . Nocturnal confirmed hypoglycemia rate was 37 % lower with IDegAsp than IDet ( 3.71 vs. 5.72 episodes/patient-year , P < 0.05 ) . Weight gain was 2.3 and 1.3 kg with IDegAsp and IDet , respectively ( P < 0.05 ) . Total insulin dose was 13 % lower in the IDegAsp group ( P < 0.0001 ) . No treatment differences were detected in Health-Related Quality of Life , laboratory measurements , physical examination , vital signs , electrocardiograms , fundoscopy , or adverse events . CONCLUSIONS IDegAsp in basal-bolus therapy with IAsp at additional mealtimes improves overall glycemic control and was non-inferior to IDet , with a reduced risk of nocturnal hypoglycemia and fewer injections in comparison with IDet + IAsp basal-bolus therapy AIMS Insulin is lipogenic and may invoke inflammation . We wished to determine if well controlled human and mice with type 1 diabetes had iatrogenic hyperinsulinemia as an explanation for the increased rate of coronary artery disease ( CAD ) in type 1 diabetes . METHODS Type 1 diabetic subjects with HbA1C less than 7.0 % had plasma insulin measured before and one hour after a Boost ® challenge and a dose of subcutaneously administered insulin . These levels were compared with non-diabetic humans . Plasma insulin levels in well controlled NOD mice with type 1 diabetes were measured 3 h and 17 h after their usual dose of insulin . Hepatic cholesterol-relevant CAD and inflammation markers were measured in the NOD mice . RESULT Marked iatrogenic hyperinsulinemia was observed in patients at levels of approximately two times higher than in non-diabetic controls . Similar findings were present in the NOD mice . Hepatic CAD risk markers were increased by insulin , but did not exceed normal expression levels in non-diabetic mice with lower insulin . In contrast , insulin-mediated stimulation of pro-inflammatory mediators TNF-α and IL-1β remained significantly higher in hyperinsulinemic NOD than non-diabetic mice . CONCLUSION Optimal insulin therapy in mice and humans with type 1 diabetes causes iatrogenic hyperinsulinemia and subsequently promotes pro-inflammatory macrophage response independent of hepatic cholesterol-relevant CAD markers . The tight glycemic control in type 1 diabetes may thus increase the risk for atherogenesis via inflammation \n Output:\n " }, { "from": "agent", "value": "Conclusions Basal – bolus treatment with insulin degludec was superior to long-acting insulin analogues detemir and glargine in reducing the rate of nocturnal hypoglycaemia .\nIn comparison with other long-acting analogues , treatment with insulin degludec was safe and patients obtained similar metabolic control expressed by HbA1c and FPG levels with the added benefit of a reduced basal and total insulin dose" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background As a result of inappropriate feeding , poor health and hygiene , and poor caring practice s , the nutritional status of many young infants deteriorates with advancing age . Objective To explore the effectiveness of a nutrition education package to prevent malnutrition among young children . Methods A community-based , r and omized , controlled trial was conducted among 605 normal and mildly malnourished children aged 6 to 9 months in 121 Community Nutrition Centers ( CNCs ) of the Bangladesh Integrated Nutrition Project ( BINP ) in four regions of Bangladesh from 2000 to 2002 . The intervention group received weekly nutrition education based on the nutrition triangle concept of UNICEF for 6 months , whereas the control group received regular BINP services . Both groups were observed for a further 6 months to assess the sustainability of the effects . Information on socio-economic status , feeding patterns , morbidity , and anthropometric features was collected . Results A significant increase in the frequency of complementary feeding was observed in the intervention group as compared with the control group , and the increase was sustained throughout the observation period . The intervention group had a higher weight gain than the control group after the end of the intervention ( 0.86 vs. 0.77 kg , p = 0.053 ) and after the end of the observation period ( 1.81 vs. 1.39 kg , p < .001 ) . The proportion of normal and mildly malnourished children was greater in the intervention group than in the control group after the end of the observations ( 88.9 % vs. 61.5 % , p < .001 ) . Nutrition education successfully prevented malnutrition in all the areas . Variation in the outcome of nutrition education among the regions was observed . Conclusions This culturally appropriate nutrition education package based on the nutrition triangle model effectively prevented growth faltering and malnutrition among young children ABSTRACT OBJECTIVE To assess the effect of educational dietary intervention offered in the child ’s first year of life , as well as teenage mothers and gr and mothers in carrying out the dietary recommendations at four to seven years . METHODS R and omized clinical trial initiated in 2006 , in Porto Alegre , RS , involving 323 teenage mothers and gr and mothers who cohabited . The intervention consisted of six counseling sessions on breastfeeding and healthy complementary feeding . The first session occurred in the maternity ward and the other ones in the households of mothers at seven , 15 , 30 , 60 , and 120 days of the child ’s life . The information about the child ’s diet were obtained on a monthly basis in the first six months , every two months in the second half-year , and at four to seven years , using a food frequency question naire . To assess the adequacy of food consumption to the recommendations from the Ministry of Health , we elaborated a score system that would reflect the compliance with the Ten Steps for Healthy Toddlers from 2 to 10 Years . The average scores of intervention and control groups were compared using the t-test . RESULTS Low adherence to recommendations on child nutrition was found in the study population , with no difference in implementation the steps between the groups . The score on the compliance with the steps was similar in both groups ( 9.6 [ SD = 1.63 ] and 9.3 [ SD = 1.60 ] in the intervention and control groups , respectively ) and no influence of the cohabitation with the gr and mother was found . CONCLUSIONS Educational dietary intervention in the first four months of the child ’s life for teenage mothers and gr and mothers had no effect on the compliance with the recommendations at four to seven years of the child ’s life Summary Background Many countries now offer support to teenage mothers to help them to achieve long-term socioeconomic stability and to give a successful start to their children . The Family Nurse Partnership ( FNP ) is a licensed intensive home-visiting intervention developed in the USA and introduced into practice in Engl and that involves up to 64 structured home visits from early pregnancy until the child 's second birthday by specially recruited and trained family nurses . We aim ed to assess the effectiveness of giving the programme to teenage first-time mothers on infant and maternal outcomes up to 24 months after birth . Methods We did a pragmatic , non-blinded , r and omised controlled , parallel-group trial in community midwifery setting s at 18 partnerships between local authorities and primary and secondary care organisations in Engl and . Eligible participants were nulliparous and aged 19 years or younger , and were recruited at less than 25 weeks ' gestation . Field-based research ers r and omly allocated mothers ( 1:1 ) via remote r and omisation ( telephone and web ) to FNP plus usual care ( publicly funded health and social care ) or to usual care alone . Allocation was stratified by site and minimised by gestation ( < 16 weeks vs ≥16 weeks ) , smoking status ( yes vs no ) , and preferred language of data collection ( English vs non-English ) . Mothers and assessors ( local research ers at baseline and 24 months ' follow-up ) were not masked to group allocation , but telephone interviewers were blinded . Primary endpoints were biomarker-calibrated self-reported tobacco use by the mother at late pregnancy , birthweight of the baby , the proportion of women with a second pregnancy within 24 months post-partum , and emergency attendances and hospital admissions for the child within 24 months post-partum . Analyses were by intention to treat . This trial is registered with IS RCT N , number IS RCT N23019866 . Findings Between June 16 , 2009 , and July 28 , 2010 , we screened 3251 women . After enrolment , 823 women were r and omly assigned to receive FNP and 822 to usual care . All follow-up data were retrieved by April 25 , 2014 . 304 ( 56 % ) of 547 women assigned to FNP and 306 ( 56 % ) of 545 assigned to usual care smoked at late pregnancy ( adjusted odds ratio [ AOR ] 0·90 , 97·5 % CI 0·64–1·28 ) . Mean birthweight of 742 babies with mothers assigned to FNP was 3217·4 g ( SD 618·0 ) , whereas birthweight of 768 babies assigned to usual care was 3197·5 g ( SD 581·5 ; adjusted mean difference 20·75 g , 97·5 % CI −47·73 to 89·23 . 587 ( 81 % ) of 725 assessed children with mothers assigned to FNP and 577 ( 77 % ) of 753 assessed children assigned to usual care attended an emergency department or were admitted to hospital at least once before their second birthday ( AOR 1·32 , 97·5 % CI 0·99–1·76 ) . 426 ( 66 % ) of 643 assessed women assigned to FNP and 427 ( 66 % ) 646 assigned to usual care had a second pregnancy within 2 years ( AOR 1·01 , 0·77–1·33 ) . At least one serious adverse event ( mainly clinical events associated with pregnancy and infancy period ) was reported for 310 ( 38 % ) of 808 participants ( mother – child ) in the usual care group and 357 ( 44 % ) of 810 in the FNP group , none of which were considered related to the intervention . Interpretation Adding FNP to the usually provided health and social care provided no additional short-term benefit to our primary outcomes . Programme continuation is not justified on the basis of available evidence , but could be reconsidered should supportive longer-term evidence emerge . Funding Department of Health Policy Research Programme OBJECTIVE To assess the impact of a child feeding training program for primary care health professionals about breastfeeding and complementary feeding practice s. METHODS Cluster-r and omized field trial conducted in the city of Porto Alegre , ( RS ) , Brazil . Twenty primary health care centers ( HCC ) were r and omized into intervention ( n = 9 ) and control ( n = 11 ) groups . The health professionals ( n = 200 ) at the intervention group centers received training about healthy feeding practice s. Pregnant women were enrolled at the study . Up to six months of child 's age , home visits were made to obtain variables related to breastfeeding and introduction of foods . RESULTS 619 children were evaluated : 318 from the intervention group and 301 from the control group . Exclusive breastfeeding prevalence in the first ( 72.3 versus 59.4 % ; RR = 1.21 ; 95%CI 1.08 - 1.38 ) , second ( 62.6 versus 48.2 % ; RR = 1.29 ; 95%CI 1.10 - 1.53 ) , and third months of life ( 44.0 % versus 34.6 % ; RR = 1.27 ; 95%CI 1.04 - 1.56 ) was higher in the intervention group compared to the control group . The prevalence of children who consumed meat four or five times per week was higher in the intervention group than in the control group ( 36.8 versus 22.6 % ; RR = 1.62 ; 95%CI 1.32 - 2.03 ) . The prevalence of children who had consumed soft drinks ( 34.9 versus 52.5 % ; RR = 0.66 ; 95%CI 0.54 - 0.80 ) , chocolate ( 24.5 versus 36.7 % RR = 0.66 95%CI 0.53 - 0.83 ) , petit suisse ( 68.9 versus 79.7 ; 95%CI 0.75 - 0.98 ) and coffee ( 10.4 versus 20.1 % ; RR = 0.51 ; 95%CI 0.31 - 0.85 ) in their six first months of life was lower in the intervention group . CONCLUSION The training of health professionals had a positive impact on infant feeding practice s , contributing to the promotion of child health The WHO ( 2001 ) recommends exclusive breast-feeding and delaying the introduction of solid foods to an infant 's diet until 6 months postpartum . However , in many countries , this recommendation is followed by few mothers , and earlier weaning onto solids is a commonly reported global practice . Therefore , this prospect i ve , observational study aim ed to assess compliance with the WHO recommendation and examine weaning practice s , including the timing of weaning of infants , and to investigate the factors that predict weaning at ≤ 12 weeks . From an initial sample of 539 pregnant women recruited from the Coombe Women and Infants University Hospital , Dublin , 401 eligible mothers were followed up at 6 weeks and 6 months postpartum . Quantitative data were obtained on mothers ' weaning practice s using semi-structured question naires and a short dietary history of the infant 's usual diet at 6 months . Only one mother ( 0.2 % ) complied with the WHO recommendation to exclusively breastfeed up to 6 months . Ninety-one ( 22.6 % ) infants were prematurely weaned onto solids at ≤ 12 weeks with predictive factors after adjustment , including mothers ' antenatal reporting that infants should be weaned onto solids at ≤ 12 weeks , formula feeding at 12 weeks and mothers ' reporting of the maternal gr and mother as the principal source of advice on infant feeding . Mothers who weaned their infants at ≤ 12 weeks were more likely to engage in other sub-optimal weaning practice s , including the addition of non-recommended condiments to their infants ' foods . Provision of professional advice and exploring antenatal maternal misperceptions are potential areas for targeted interventions to improve compliance with the recommended weaning practice The effectiveness of in-hospital self-care patient education , delivered to patients following heart surgery , is question able , as evidence indicates individuals are not able to absorb and /or retain information at this time . In the absence of adequate instruction , individuals will not have the relevant information to engage in specific self-care behaviors , result ing in the onset of complications and /or hospital readmissions . The purpose of this pilot study was to collect preliminary evidence to demonstrate the impact of an individualized education intervention given above and beyond usual care , delivered , at two points in time , following hospital discharge . A r and omized controlled trial was used in which 34 patients were r and omly assigned to one of two groups . Chi-square analyses to examine differences between groups on complications and hospital readmission rates were conducted . Findings point to the impact of the intervention in reducing the number of hospital readmissions and complications at 3 months following hospital discharge Background Many HIV/AIDS patients experience pain often due to advanced HIV/AIDS infection and side effects of treatment . In sub-Saharan Africa , pain management for people with HIV/AIDS is suboptimal . With survival extended as a direct consequence of improved access to antiretroviral therapy , the prevalence of HIV/AIDS related pain is increasing . As most care is provided at home , the management of pain requires patient and family involvement . Pain education is an important aspect in the management of pain in HIV/AIDS patients . Studies of the effectiveness of pain education interventions for people with HIV/AIDS have been conducted almost exclusively in western countries . Methods / design A r and omised controlled trial is being conducted at the HIV and palliative care clinics of two public hospitals in Malawi . To be elig \n Output:\n " }, { "from": "agent", "value": "There was limited ( low to very low- quality ) evidence of an effect for all growth outcomes .\nQuality of evidence There is moderate to very low- quality evidence that educational interventions can improve complementary feeding practice s but insufficient evidence to conclude that it impacts growth outcomes .\nAUTHORS ' CONCLUSIONS Overall , we found evidence that education improves complementary feeding practice" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective To vali date use of the Manchester triage system in paediatric emergency care . Design Prospect i ve observational study . Setting Emergency departments of a university hospital and a teaching hospital in the Netherl and s , 2006 - 7 . Participants 17 600 children ( aged < 16 ) visiting an emergency department over 13 months ( university hospital ) and seven months ( teaching hospital ) . Intervention Nurses triaged 16 735/17 600 patients ( 95 % ) using a computerised Manchester triage system , which calculated urgency levels from the selection of discriminators embedded in flowcharts for presenting problems . Nurses over-ruled the urgency level in 1714 ( 10 % ) children , who were excluded from analysis . Complete data for the reference st and ard were unavailable in 1467 ( 9 % ) children leaving 13 554 patients for analysis . Main outcome measures Urgency according to the Manchester triage system compared with a predefined and independently assessed reference st and ard for five urgency levels . This reference st and ard was based on a combination of vital signs at presentation , potentially life threatening conditions , diagnostic re sources , therapeutic interventions , and follow-up . Sensitivity , specificity , and likelihood ratios for high urgency ( immediate and very urgent ) and 95 % confidence intervals for subgroups based on age , use of flowcharts , and discriminators . Results The Manchester urgency level agreed with the reference st and ard in 4582 of 13 554 ( 34 % ) children ; 7311 ( 54 % ) were over-triaged and 1661 ( 12 % ) under-triaged . The likelihood ratio was 3.0 ( 95 % confidence interval 2.8 to 3.2 ) for high urgency and 0.5 ( 0.4 to 0.5 ) for low urgency ; though the likelihood ratios were lower for those presenting with a medical problem ( 2.3 ( 2.2 to 2.5 ) v 12.0 ( 7.8 to 18.0 ) for trauma ) and in younger children ( 2.4 ( 1.9 to 2.9 ) at 0 - 3 months v 5.4 ( 4.5 to 6.5 ) at 8 - 16 years ) . Conclusions The Manchester triage system has moderate validity in paediatric emergency care . It errs on the safe side , with much more over-triage than under-triage compared with an independent reference st and ard for urgency . Triage of patients with a medical problem or in younger children is particularly difficult OBJECTIVES Initial studies have shown improved reliability and validity of a new triage tool , the Emergency Severity Index ( ESI ) , over conventional three-level scales at two university medical centers . After pilot implementation and validation , the ESI was revised to include pediatric and up date d vital signs criteria . The goal of this study was to assess ESI version ( v. ) 2 reliability and validity at seven emergency departments ( EDs ) in three states . METHODS In part 1 , interrater reliability was assessed using weighted kappa analysis of written training cases and postimplementation by a r and om sampling of actual patient triages . In part 2 , validity was analyzed using a prospect i ve cohort with stratified r and om sampling at each site . The ESI was compared with outcomes including re source consumption , inpatient admission , ED length of stay , and 60-day all-cause mortality . RESULTS Weighted kappa analysis of interrater reliability ranged from 0.70 to 0.80 for the written scenarios ( n = 3289 ) and 0.69 to 0.87 for patient triages ( n = 386 ) . Outcomes for the validity cohort ( n = 1042 ) included hospitalization rates by ESI triage level : level 1 , 83 % ; 2 , 67 % ; 3 , 42 % ; 4 , 8 % ; level 5 , 4 % . Sixty-day all-cause mortality by triage level was as follows : level 1 , 25 % ; 2 , 4 % ; 3 , 2 % ; 4 , 1 % ; and 5 , 0 % . CONCLUSIONS ESI v. 2 triage produced reliable , valid stratification of patients across seven sites . ESI triage should be evaluated as an ED casemix identification system for uniform data collection in the United States and compared with other major ED triage methods Introduction The FRench Emergency Nurses Classification in Hospital scale ( FRENCH ) is the first French triage tool for patients visiting an emergency department . The FRENCH scale modified in 2006 , based on about 100 determinants ( complaints , signs , and vital parameters ) , allows the triage of adult patients according to five increasing levels of complexity/severity . We evaluated FRENCH version 2 ( v.2 ) in our emergency department . Methods Reliability was evaluated on 300 prospect ively selected patient records ( 50 % of patients admitted ) . Three nurse pairs , blinded with respect to the original triage , retrospectively and independently triaged 100 patients . Interrater reliability within the pairs was measured with a weighted κ . Validity was evaluated on all triaged patients ( N=941 ) over 14 days by study ing the relationships between the original triage category assigned by the triage nurse and re source consumption and the admission rate . Results Interrater reliability was good [ K=0.77 ( 95 % confidence interval : 0.71–0.82 ) ] . Distribution of the 941 patients included in the validation study ( 18 % of whom were admitted ) was as follows [ n ( % ) ] : 2 ( 0.2 ) , 33 ( 4 ) , 258 ( 27 ) , 451 ( 48 ) , and 197 ( 21 ) for a triage from 1 to 5 , respectively . Re source consumption correlated well with case severity as assessed by the triage category ( R=−0.643 , P<0.0001 ) . Finally , the area under the receiver operating characteristic curve for prediction of admission as a function of triage was 0.858 ( 95 % confidence interval : 0.831–0.885 ) . Conclusion FRENCH v.2 is a reliable and vali date d triage tool to predict the complexity/severity of a patient in our emergency department Background The Manchester Triage System ( MTS ) determines an inappropriately low level of urgency ( undertriage ) to a minority of children . The aim of the study was to assess the clinical severity of undertriaged patients in the MTS and to define the determinants of undertriage . Methods Patients who had attended the emergency department ( ED ) were triaged according to the MTS . Undertriage was defined as a ‘ low urgent ’ classification ( levels 3 , 4 and 5 ) under the MTS ; as a ‘ high urgent ’ classification ( levels 1 and 2 ) under an independent reference st and ard based on abnormal vital signs ( level 1 ) , potentially life-threatening conditions ( level 2 ) , and a combination of re source use , hospitalisation , and follow-up for the three lowest urgency levels . In an expert meeting , three experienced paediatricians used a st and ardised format to determine the clinical severity . The clinical severity had been expressed by possible consequences of treatment delay caused by undertriage , such as the use of more interventions and diagnostics , longer hospitalisation , complications , morbidity , and mortality . In a prospect i ve observational study we used logistic regression analysis to assess predictors for undertriage . Results In total , 0.9 % ( 119/13,408 ) of the patients were undertriaged . In 53 % ( 63/119 ) of these patients , experts considered undertriage as clinical ly severe . In 89 % ( 56/63 ) of these patients the high reference urgency was determined on the basis of abnormal vital signs . The prospect i ve observational study showed undertriage was more likely in infants ( especially those younger than three months ) , and in children assigned to the MTS ‘ unwell child ’ flowchart ( adjusted OR<3 months 4.2 , 95 % CI 2.3 to 7.7 and adjusted ORunwell child 11.1 , 95 % CI 5.5 to 22.3 ) . Conclusion Undertriage is infrequent , but can have serious clinical consequences . To reduce significant undertriage , the authors recommend a systematic assessment of vital signs in all children OBJECTIVES The objective was to compare the validity of an existing informally structured triage system with the Emergency Severity Index ( ESI ) and the Manchester Triage System ( MTS ) . METHODS A total of 900 patients were prospect ively triaged by six trained triage nurses using the three systems . Triage ratings of 421 ( 48 % ) patients treated only by emergency department ( ED ) physicians were compared with a reference st and ard determined by an expert panel . The percentage of undertriage , the sensitivity , and the specificity for each urgency level were calculated . The relationship between urgency level , re source use , hospitalization , and length of stay ( LOS ) in the 900 triaged patients was determined . RESULTS The percentage of undertriage using the ESI ( 86 of 421 ; 20 % ) was significantly higher than in the MTS ( 48 of 421 ; 11 % ) . When combining urgency levels 4 and 5 , the percentage of undertriage was 8 % for the informally structured system ( ISS ) , 14 % for the ESI , and 11 % for the MTS . In all three systems , sensitivity for all urgency levels was low , but specificity for levels 1 and 2 was high ( > 92 % ) . Sensitivity and specificity were significantly different between ESI and MTS only in urgency level 4 . In all 900 patients triaged , urgency levels across all systems were associated with significantly increased re source use , hospitalization rate , and LOS . CONCLUSIONS All three triage systems appear to be equally valid . Although the ESI showed the highest percentage of undertriage and the ISS the lowest , it seems preferable to use a verifiable , formally structured triage system Objective : To assess the reliability and validity of the Manchester Triage System ( MTS ) in a general emergency department patient population . Methods : A prospect i ve evaluation study was conducted in two general hospitals in the Netherl and s. Emergency department nurses from both hospitals triaged 50 patient vignettes into one of five triage categories in the MTS . Triage ratings were compared with the ratings of two Dutch MTS experts to measure inter-rater reliability . Nineteen days after triaging the patient vignettes , triage nurses were asked to rate the same vignettes again to measure test-retest reliability . Reliability in relation to the work experience of emergency department nurses was also studied . Validity was assessed by calculating percentages for overtriage , undertriage , sensitivity and specificity . Results : Inter-rater reliability was “ substantial ” ( weighted kappa 0.62 ( 95 % CI 0.60 to 0.65 ) ) and test-retest reliability was high ( intraclass correlation coefficient 0.75 ( 95 % CI 0.72 to 0.77 ) ) . No significant association was found between the experience of emergency department nurses and the reliability score ( kappa ) . Undertriage occurred more frequently than overtriage , especially in elderly patients ( 25.3 % vs 7.6 % ) . Sensitivity for urgent patients in the MTS was 53.2 % and specificity was 95.1 % . The patient vignettes representing children aged < 16 years revealed a higher sensitivity ( 83.3 % ) . Conclusions : Inter-rater reliability is “ moderate ” to “ substantial ” and test-retest reliability is high . The reliability of the MTS is not influenced by nurses ’ work experience . Undertriage mainly occurs in the MTS categories orange and yellow . The MTS is more sensitive for children who need immediate or urgent care than for other patients in the emergency department INTRODUCTION Each of the two most commonly used five-level triage tools in North America , the Emergency Severity Index and the Canadian Triage and Acuity Scale have been used as a measure of emergency department re source utilization in addition to acuity . In both cases , it is believed that patients triaged as having a higher level of acuity require a greater number of emergency department re sources . We compared the ability of each tool to predict the emergency department re sources for each emergency department visit and associated hospital admission and in-hospital mortality rates . METHODS This is an observational , cohort study of a population -based r and om sample of patients triaged at two emergency departments over a 4-month period . Correlational analyses were performed to examine the relationship between the triage assessment and : ( i ) re source utilization , ( ii ) hospital admission , and ( iii ) in-hospital mortality . RESULTS From 486 patients , analyses revealed the greatest correlation was between Emergency Severity Index and diagnostic re sources [ -0.54 ( 95 % confidence intervals : -0.58 , -0.50 ) ] and the poorest correlation was between Canadian Triage and Acuity Scale and mortality [ -0.16 ( 95 % confidence intervals : -0.20 , -0.12 ) ] . No statistically significant differences ( P<0.005 ) were observed between each tool 's ability to predict any of the outcomes measured . CONCLUSION No statistically significant difference was observed in the ability of Emergency Severity Index v. 3 and Canadian Triage and Acuity Scale to predict emergency department re source utilization or immediate patient outcomes . This ability is , at best , only moderate indicating that other , more accurate tools than measures of triage acuity are required for this purpose OBJECTIVES Triage is the initial clinical sorting process in hospital emergency departments ( EDs ) . Because of poor reproducibility and validity of three-level triage , the authors developed and vali date d a new five-level triage instrument , the Emergency Severity Index ( ESI ) . The study objectives were : 1 ) to vali \n Output:\n " }, { "from": "agent", "value": "Its safety was low because of the high rate of undertriage and the low sensitivity in predicting higher urgency levels .\nThe high rate of overtriage could cause unnecessarily high use of re sources in the emergency department ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND home-based telecare ( TC ) is utilised to manage risks of independent living and provide prompt emergency responses . This study examined the effect of TC on health-related quality of life ( HRQoL ) , anxiety and depressive symptoms over 12 months in patients receiving social care . DESIGN a study of participant-reported outcomes [ the Whole Systems Demonstrator ( WSD ) Telecare Question naire Study ; baseline n = 1,189 ] was nested in a pragmatic cluster-r and omised trial of TC ( the WSD Telecare trial ) , held across three English Local Authorities . General practice ( GP ) was the unit of r and omisation and TC was compared with usual care ( UC ) . METHODS participant-reported outcome measures were collected at baseline , short-term ( 4 months ) and long-term ( 12 months ) follow-up , assessing generic HRQoL , anxiety and depressive symptoms . Primary intention-to-treat analyses tested treatment effectiveness and were conducted using multilevel models to control for GP clustering and covariates for participants who completed question naire measures at baseline assessment plus at least one other assessment ( n = 873 ) . RESULTS analyses found significant differences between TC and UC on Short Form-12 mental component scores ( P < 0.05 ) , with parameter estimates indicating being a member of the TC trial-arm increases mental component scores ( UC-adjusted mean = 40.52 ; TC-adjusted mean = 43.69 ) . Additional significant analyses revealed , time effects on EQ5D ( decreasing over time ) and depressive symptoms ( increasing over time ) . CONCLUSIONS TC potentially contributes to the amelioration in the decline in users ' mental HRQoL over a 12-month period . TC may not transform the lives of its users , but it may afford small relative benefits on some psychological and HRQOL outcomes relative to users who only receive UC . International St and ard R and omised Controlled Trial Number Register : IS RCT N 43002091 BACKGROUND Mild frailty or pre-frailty is common and yet is potentially reversible . Preventing progression to worsening frailty may benefit individuals and lower health/social care costs . However , we know little about effective approaches to preventing frailty progression . OBJECTIVES ( 1 ) To develop an evidence - and theory-based home-based health promotion intervention for older people with mild frailty . ( 2 ) To assess feasibility , costs and acceptability of ( i ) the intervention and ( ii ) a full-scale clinical effectiveness and cost-effectiveness r and omised controlled trial ( RCT ) . DESIGN Evidence review s , qualitative studies , intervention development and a feasibility RCT with process evaluation . INTERVENTION DEVELOPMENT Two systematic review s ( including systematic search es of 14 data bases and registries , 1990 - 2016 and 1980 - 2014 ) , a state-of-the-art review ( from inception to 2015 ) and policy review identified effective components for our intervention . We collected data on health priorities and potential intervention components from semistructured interviews and focus groups with older people ( aged 65 - 94 years ) ( n = 44 ) , carers ( n = 12 ) and health/social care professionals ( n = 27 ) . These data , and our evidence review s , fed into development of the ' HomeHealth ' intervention in collaboration with older people and multidisciplinary stakeholders . ' HomeHealth ' comprised 3 - 6 sessions with a support worker trained in behaviour change techniques , communication skills , exercise , nutrition and mood . Participants addressed self-directed independence and well-being goals , supported through education , skills training , enabling individuals to overcome barriers , providing feedback , maximising motivation and promoting habit formation . FEASIBILITY RCT Single-blind RCT , individually r and omised to ' HomeHealth ' or treatment as usual ( TAU ) . SETTING Community setting s in London and Hertfordshire , UK . PARTICIPANTS A total of 51 community-dwelling adults aged ≥ 65 years with mild frailty . MAIN OUTCOME MEASURES Feasibility - recruitment , retention , acceptability and intervention costs . Clinical and health economic outcome data at 6 months included functioning , frailty status , well-being , psychological distress , quality of life , capability and NHS and societal service utilisation/costs . RESULTS We successfully recruited to target , with good 6-month retention ( 94 % ) . Trial procedures were acceptable with minimal missing data . Individual r and omisation was feasible . The intervention was acceptable , with good fidelity and modest delivery costs ( £ 307 per patient ) . A total of 96 % of participants identified at least one goal , which were mostly exercise related ( 73 % ) . We found significantly better functioning ( Barthel Index + 1.68 ; p = 0.004 ) , better grip strength ( + 6.48 kg ; p = 0.02 ) , reduced psychological distress ( 12-item General Health Question naire -3.92 ; p = 0.01 ) and increased capability-adjusted life-years [ + 0.017 ; 95 % confidence interval ( CI ) 0.001 to 0.031 ] at 6 months in the intervention arm than the TAU arm , with no differences in other outcomes . NHS and carer support costs were variable but , overall , were lower in the intervention arm than the TAU arm . The main limitation was difficulty maintaining outcome assessor blinding . CONCLUSIONS Evidence is lacking to inform frailty prevention service design , with no large-scale trials of multidomain interventions . From stakeholder/public perspectives , new frailty prevention services should be personalised and encompass multiple domains , particularly socialising and mobility , and can be delivered by trained non-specialists . Our multicomponent health promotion intervention was acceptable and delivered at modest cost . Our small study shows promise for improving clinical outcomes , including functioning and independence . A full-scale individually RCT is feasible . FUTURE WORK A large , definitive RCT of the HomeHealth service is warranted . STUDY REGISTRATION This study is registered as PROSPERO CRD42014010370 and Current Controlled Trials IS RCT N11986672 . FUNDING This project was funded by the National Institute for Health Research ( NIHR ) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol . 21 , No. 73 . See the NIHR Journals Library website for further project information Background : Achieving earlier stage diagnosis is one option for improving lung cancer outcomes in the United Kingdom . Patients with lung cancer typically present with symptoms to general practitioners several times before referral or investigation . Methods : We undertook a mixed methods feasibility individually r and omised controlled trial ( the ELCID trial ) to assess the feasibility and inform the design of a definitive , fully powered , UK-wide , Phase III trial of lowering the threshold for urgent investigation of suspected lung cancer . Patients over 60 , with a smoking history , presenting with new chest symptoms to primary care , were eligible to be r and omised to intervention ( urgent chest X-ray ) or usual care . Results : The trial design and material s were acceptable to GPs and patients . We r and omised 255 patients from 22 practice s , although the proportion of eligible patients who participated was lower than expected . Survey responses ( 89 % ) , and the fidelity of the intervention ( 82 % patients X-rayed within 3 weeks ) were good . There was slightly higher anxiety and depression in the control arm in participants aged > 75 . Three patients ( 1.2 % ) were diagnosed with lung cancer . Conclusions : We have demonstrated the feasibility of individually r and omising patients at higher risk of lung cancer , to a trial offering urgent investigation or usual care Background This study explored the effectiveness of a pro-active , integrated care model for community-dwelling frail older people compared to care as usual by evaluating the effects on a comprehensive set of outcomes : health outcomes ( experienced health , mental health and social functioning ) ; functional abilities ; and quality of life ( general , health-related and well-being ) . Methods The design of this study was quasi-experimental . In this study , 184 frail older patients of three GP practice s that implemented the Walcheren Integrated Care Model were compared with 193 frail older patients of five GP practice s that provided care as usual . In the Walcheren Integrated Care Model , community-dwelling elderly were pro-actively screened for frailty from the GP practice using the Groningen Frailty Indicator , and care needs were assessed with the EASYcare instrument . The GP practice functioned as single entry point from which case management was provided , and the GP was the coordinator of care . The entire process was supported by multidisciplinary meetings , multidisciplinary protocol s and web-based patient files . The outcomes of this study were obtained at baseline , after 3 months and after 12 months and analyzed with linear mixed models of repeated measures . Results The Walcheren Integrated Care Model had a positive effect on love and friendship and a moderately positive effect on general quality of life . The ability to receive love and friendship and general quality of life decreased in the control group but was preserved in the experimental group . No significant differences were found on health outcomes such as experienced health , mental health , social functioning and functional abilities . Conclusions The results indicated that pro-active , integrated care can be beneficial for frail older people in terms of quality of life and love and friendship but not in terms of health outcomes and functional abilities . Recommendations for future research are to gain greater insight into what specific outcomes can be achieved with proactive and integrated care , considering the specific content of this care , and to allow for the heterogeneity of frail older people in evaluation research .Trial registration Current Controlled Trials IS RCT N05748494 . Registration date : 14/03/2013 Background Lifestyle factors represent prime targets for behaviour change interventions to promote healthy ageing and reduce dementia risk . We evaluated a goal - setting intervention aim ed at promoting increased cognitive and physical activity and improving mental and physical fitness , diet and health . Methods This was a pilot r and omised controlled trial design ed to guide planning for a larger-scale investigation , provide preliminary evidence regarding efficacy , and explore feasibility and acceptability . Primary outcomes were engagement in physical and cognitive activity . Participants aged over 50 living independently in the community were recruited through a community Agewell Centre . Following baseline assessment participants were r and omly allocated to one of three conditions : control ( IC ) had an interview in which information about activities and health was discussed ; goal - setting ( GS n = 24 ) had an interview in which they set behaviour change goals relating to physical , cognitive and social activity , health and nutrition ; and goal - setting with mentoring ( GM , n = 24 ) had the goal - setting interview followed by bi-monthly telephone mentoring . Participants and research ers were blinded to group assignment . Participants were reassessed after 12 months . Results Seventy-five participants were r and omised ( IC n = 27 , GS n = 24 , GM n = 24 ) . At 12-month follow-up , the two goal - setting groups , taken together ( GS n = 21 , GM n = 22 ) , increased their level of physical ( effect size 0.37 ) and cognitive ( effect size 0.15 ) activity relative to controls ( IC n = 27 ) . In secondary outcomes , the two goal - setting groups taken together achieved additional benefits compared to control ( effect sizes ≥ 0.2 ) in memory , executive function , cholesterol level , aerobic capacity , flexibility , balance , grip strength , and agility . Adding follow-up mentoring produced further benefits compared to goal - setting alone ( effect sizes ≥ 0.2 ) in physical activity , body composition , global cognition and memory , but not in other domains . Implementation of the recruitment procedure , assessment and intervention was found to be feasible and the approach taken was acceptable to participants , with no adverse effects . Conclusions A brief , low-cost goal - setting intervention is feasible and acceptable , and has the potential to achieve increased activity engagement . Trial registration Current Controlled Trials IS RCT Abstract Purpose : To evaluate the impact of a person-centred , community rehabilitation service on outcomes for people with a neurological condition , in the first year of service . Method : A prospect i ve , observational , pre-post study was conducted with 206 people who had a neurological condition and attended the rehabilitation service to restore function ( e.g. , Stroke ) ; maximize recovery in an ongoing situation ( e.g. , Spina Bifida ) ; or maximize function and independence while preparing for inevitable decline ( e.g. , Parkinson ’s Disease ) . Outcomes were measured via self-report question naires , prior to , and following three months of rehabilitation . The primary outcome was achievement of self-identified goals , measured by the Patient-Specific Functional scale . Secondary outcomes included the Lawton Instrumental Activities of Daily Living ( IADL ) scale , EQ-5D-5L European Quality of Life scale , and ICECAP-O – Index of Capability for Older Adults and health and medical re source use . Results : Participants demonstrated significant goal achievement and a significant reduction in health and medical re source use . There were small positive changes in the Lawton IADL , EQ-5D-5L , and ICECAP-O however these changes were not significant . Conclusions : In the first year of operation , the community rehabilitation service made a significant impact on outcomes for individuals with a neurological condition . Further research is required to identify appropriate measures of activities of daily living and quality of life that reflect person-centred rehabilitation outcomes for restoring function , maximizing function , or preparing for functional decline . Implication s for Rehabilitation Self-identified goals are an important guide for achievement of meaningful outcomes for individuals with a neurological condition . Person-centred outcome measures are required to evaluate the benefits of a \n Output:\n " }, { "from": "agent", "value": "The ICECAP-O has good construct validity and responsiveness , but there is evidence of some issues relating to content validity .\nConclusion Focus , in terms of publications , appears to have shifted now from assessment of psychometric properties to the utilisation of the ICECAP-O within economic evaluation ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Cigarette smoking is a tough addiction to break . Therefore , improved approaches to smoking cessation are necessary . The electronic-cigarette ( e-Cigarette ) , a battery-powered electronic nicotine delivery device ( ENDD ) resembling a cigarette , may help smokers to remain abstinent during their quit attempt or to reduce cigarette consumption . Efficacy and safety of these devices in long-term smoking cessation and /or smoking reduction studies have never been investigated . Methods In this prospect i ve proof-of-concept study we monitored possible modifications in smoking habits of 40 regular smokers ( unwilling to quit ) experimenting the ' Categoria ' e-Cigarette with a focus on smoking reduction and smoking abstinence . Study participants were invited to attend a total of five study visits : at baseline , week-4 , week-8 , week-12 and week-24 . Product use , number of cigarettes smoked , and exhaled carbon monoxide ( eCO ) levels were measured at each visit . Smoking reduction and abstinence rates were calculated . Adverse events and product preferences were also review ed . Results Sustained 50 % reduction in the number of cig/day at week-24 was shown in 13/40(32.5 % ) participants ; their median of 25 cigs/day decreasing to 6 cigs/day ( p < 0.001 ) . Sustained 80 % reduction was shown in 5/40(12.5 % ) participants ; their median of 30 cigs/day decreasing to 3 cigs/day ( p = 0.043 ) . Sustained smoking abstinence at week-24 was observed in 9/40(22.5 % ) participants , with 6/9 still using the e-Cigarette by the end of the study . Combined sustained 50 % reduction and smoking abstinence was shown in 22/40 ( 55 % ) participants , with an overall 88 % fall in cigs/day . Mouth ( 20.6 % ) and throat ( 32.4 % ) irritation , and dry cough ( 32.4 % ) were common , but diminished substantially by week-24 . Overall , 2 to 3 cartridges/day were used throughout the study . Participants ' perception and acceptance of the product was good . Conclusion The use of e-Cigarette substantially decreased cigarette consumption without causing significant side effects in smokers not intending to quit ( http:// Clinical Trials.gov number NCT01195597 ) Electronic cigarettes ( e-Cigarette ) are battery-operated devices design ed to vaporise nicotine that may aid smokers to quit or reduce their cigarette consumption . Research on e-Cigarettes is urgently needed to ensure that the decisions of regulators , healthcare providers and consumers are evidence based . Here we assessed long-term effectiveness and tolerability of e-Cigarette used in a ‘ naturalistic ’ setting . This prospect i ve observational study evaluated smoking reduction/abstinence in smokers not intending to quit using an e-Cigarette ( ‘ Categoria ’ ; Arbi Group , Italy ) . After an intervention phase of 6 months , during which e-Cigarette use was provided on a regular basis , cigarettes per day ( cig/day ) and exhaled carbon monoxide ( eCO ) levels were followed up in an observation phase at 18 and 24 months . Efficacy measures included : ( a ) ≥50 % reduction in the number of cig/day from baseline , defined as self-reported reduction in the number of cig/day ( ≥50 % ) compared to baseline ; ( b ) ≥80 % reduction in the number of cig/day from baseline , defined as self-reported reduction in the number of cig/day ( ≥80 % ) compared to baseline ; ( c ) abstinence from smoking , defined as complete self-reported abstinence from tobacco smoking ( together with an eCO concentration of ≤10 ppm ) . Smoking reduction and abstinence rates were computed , and adverse events review ed . Of the 40 subjects , 17 were lost to follow-up at 24 months . A > 50 % reduction in the number of cig/day at 24 months was shown in 11/40 ( 27.5 % ) participants with a median of 24 cig/day use at baseline decreasing significantly to 4 cig/day ( p = 0.003 ) . Smoking abstinence was reported in 5/40 ( 12.5 % ) participants while combined > 50 % reduction and smoking abstinence was observed in 16/40 ( 40 % ) participants at 24 months . Five subjects stopped e-Cigarette use ( and stayed quit ) , three relapsed back to tobacco smoking and four up grade d to more performing products by 24 months . Only some mouth irritation , throat irritation , and dry cough were reported . Withdrawal symptoms were uncommon . Long-term e-Cigarette use can substantially decrease cigarette consumption in smokers not willing to quit and is well tolerated . ( http:// Clinical Trials.govnumberNCT01195597 ) Background While electronic cigarettes are forbidden in several countries , their sales are exploding in many others . Although e-cigarettes have been proposed as long-term substitutes for traditional smoking or as a tool for smoking cessation , very scarce data are available on their efficacy and safety . We describe the protocol of a 5-year multicentric prospect i ve study aim ed to evaluate short- and long-term adherence to e-cigarette smoking and the efficacy of e-cigarettes in reducing and /or quitting traditional cigarette smoking . The study will also compare the health effects of electronic vs traditional vs mixed cigarette smoking . Methods / design From June to December 2013 , we will enroll adult smokers of : ( EC ) e-cigarettes ( self-reported inhaling ≥ 50 puffs per week since ≥ 6 months ) ; ( TC ) traditional cigarettes ( ≥ 1 per day since ≥ 6 m ) ; ( Mixed ) both electronic and traditional cigarettes ( ≥1 per day since ≥ 6 m ) . Eligible subjects will be requested participation through newspaper advertisements and direct contact at the shops . Each subject will have to compile a structured question naire at enrolment and after 6 , 12 , 24 , 36 and 60 months . The level of carbon monoxide in expired after breath will be evaluated in all subjects declaring no traditional cigarette smoking in any follow-up phase , using portable carbon monoxide analyzers . The primary outcomes are traditional smoking cessation rates and number of smoked cigarettes . Secondary outcomes include adherence to e-cigarettes , self-reported adverse events , quality of life , and time to hospital admission for one among cardiovascular diseases , chronic obstructive pulmonary diseases , cancer of the lung , esophagus , larynx , oral cavity , bladder , pancreas , kidney , stomach , cervix , and myeloid leukemia . Admissions will be checked using official discharge data of the Abruzzo Region . A minimum of 500 subjects in each group will be enrolled , for a total of 1500 participants . Cox proportional hazards analysis will be used to calculate adjusted relative hazards of smoking cessation by each variable . Discussion Data on long-term efficacy and safety of e-cigarettes will be of utmost importance to form the basis for guidelines and regulatory decisions on e-cigarettes . Trial registration The protocol has been registered ( NCT01785537 ) and approved by the Ethics Committee of the University of Chieti ( Record n. 6 ; 25 - 03 - 2013 ) Background Electronic cigarettes ( e-cigarettes ) are becoming increasingly popular with smokers worldwide . Users report buying them to help quit smoking , to reduce cigarette consumption , to relieve tobacco withdrawal symptoms , and to continue having a ‘ smoking ’ experience , but with reduced health risks . Research on e-cigarettes is urgently needed in order to ensure that the decisions of regulators , healthcare providers and consumers are based on science . Methods ECLAT is a prospect i ve 12-month r and omized , controlled trial that evaluates smoking reduction/abstinence in 300 smokers not intending to quit experimenting two different nicotine strengths of a popular e-cigarette model ( ‘ Categoria ’ ; Arbi Group Srl , Italy ) compared to its non-nicotine choice . GroupA ( n = 100 ) received 7.2 mg nicotine cartridges for 12 weeks ; GroupB ( n = 100 ) , a 6-week 7.2 mg nicotine cartridges followed by a further 6-week 5.4 mg nicotine cartridges ; GroupC ( n = 100 ) received no-nicotine cartridges for 12 weeks . The study consisted of nine visits during which cig/day use and exhaled carbon monoxide ( eCO ) levels were measured . Smoking reduction and abstinence rates were calculated . Adverse events and product preferences were also review ed . Results Declines in cig/day use and eCO levels were observed at each study visits in all three study groups ( p<0.001 vs baseline ) , with no consistent differences among study groups . Smoking reduction was documented in 22.3 % and 10.3 % at week-12 and week-52 respectively . Complete abstinence from tobacco smoking was documented in 10.7 % and 8.7 % at week-12 and week-52 respectively . A substantial decrease in adverse events from baseline was observed and withdrawal symptoms were infrequently reported during the study . Participants ’ perception and acceptance of the product under investigation was satisfactory . Conclusion In smokers not intending to quit , the use of e-cigarettes , with or without nicotine , decreased cigarette consumption and elicited enduring tobacco abstinence without causing significant side effects . Trial Registration Clinical Trials.gov NCT01164072 Background : Smoking reduction remains a pivotal issue in public health policy , but quit rates obtained with traditional quit-smoking therapies remain disappointingly low . Tobacco Harm Reduction ( THR ) , aim ing at less harmful ways of consuming nicotine , may provide a more effective alternative . One promising c and i date for THR are electronic cigarettes ( e-cigs ) . The aim of this study was to investigate the efficacy of second-generation e-cigs both in terms of acute craving-reduction in the lab and in terms of smoking reduction and experienced benefits /complaints in an eight-month R and omized Controlled Trial ( RCT ) . Design : RCT with three arms . Methods : Participants ( N = 48 ) unwilling to quit smoking were r and omized into two e-cig groups and one control group . During three lab sessions ( over two months ) participants , who had been abstinent for four hours , vaped/smoked for five minutes , after which we monitored the effect on craving and withdrawal symptoms . eCO and saliva cotinine levels were also measured . In between lab sessions , participants in the e-cig groups could use e-cigs or smoke ad libitum , whereas the control group could only smoke . After the lab sessions , the control group also received an e-cig . The RCT included several question naires , which repeatedly monitored the effect of ad libitum e-cig use on the use of tobacco cigarettes and the experienced benefits /complaints up to six months after the last lab session . Results : From the first lab session on , e-cig use after four hours of abstinence result ed in a reduction in cigarette craving which was of the same magnitude as when a cigarette was smoked , while eCO was unaffected . After two months , we observed that 34 % of the e-cig groups had stopped smoking tobacco cigarettes , versus 0 % of the control group ( difference p < 0.01 ) . After five months , the e-cig groups demonstrated a total quit-rate of 37 % , whereas the control group showed a quit rate of 38 % three months after initiating e-cig use . At the end of the eight-month study , 19 % of the e-cig groups and 25 % of the control group were totally abstinent from smoking , while an overall reduction of 60 % in the number of cigarettes smoked per day was observed ( compared to intake ) . eCO levels decreased , whereas cotinine levels were the same in all groups at each moment of measurement . Reported benefits far outweighed the reported complaints . Conclusion : In a series of controlled lab sessions with e-cig naïve tobacco smokers , second generation e-cigs were shown to be immediately and highly effective in reducing abstinence induced cigarette craving and withdrawal symptoms , while not result ing in increases in eCO . Remarkable ( > 50 pc ) eight-month reductions in , or complete abstinence from tobacco smoking was achieved with the e-cig in almost half ( 44 % ) of the participants BACKGROUND Electronic cigarettes ( e-cigarettes ) can deliver nicotine and mitigate tobacco withdrawal and are used by many smokers to assist quit attempts . We investigated whether e-cigarettes are more effective than nicotine patches at helping smokers to quit . METHODS We did this pragmatic r and omised-controlled superiority trial in Auckl and , New Zeal and , between Sept 6 , 2011 , and July 5 , 2013 . Adult ( ≥18 years ) smokers wanting to quit were r and omised ( with computerised block r and omisation , block size nine , stratified by ethnicity [ Māori ; Pacific ; or non-Māori , non-Pacific ] , sex [ men or women ] , and level of nicotine dependence [ \n Output:\n " }, { "from": "agent", "value": "There is evidence from a recent Cochrane review of RCTs that ECs can support smoking cessation .\nThere are emerging data indicating that potentially harmful components of ECs such as tobacco-specific nitrosamines , polyaromatic hydrocarbons , and heavy metals could be linked to possible urologic health risks .\nCONCLUSIONS ECs might be a useful tool to encourage cessation of conventional cigarette smoking .\nPATIENT SUMMARY While electronic cigarettes might help some people to stop smoking , their overall impact on urologic health is not clear" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Study Design . A r and omized trial . Objective . To evaluate the effectiveness of a semi-intensive multidisciplinary rehabilitation for patients with chronic low back pain in an outpatient setting . Summary and Background Data . Systematic review s have shown that there is strong evidence that intensive multidisciplinary treatment ( > 100 hours ) , which includes functional restoration , improves function among chronic patients with low back pain , and moderate evidence that it reduces pain but contradictory evidence regarding improvement of working ability . However , there is paucity of data whether semi-intensive outpatient multidisciplinary rehabilitation in groups is more effective than individual physiotherapy . Material s and Methods . A total of 120 women employed as healthcare and social care professionals with nonspecific chronic low back pain were recruited from two occupational healthcare centers . The patients were r and omized into two intervention programs . Multidisciplinary rehabilitation ( n = 59 ) was conducted in groups and comprised of physical training , workplace interventions , back school , relaxation training , and cognitive-behavioral stress management methods for 70 hours . The individual physiotherapy ( n = 61 ) included physical exercise and passive treatment methods administered for 10 hours . Main outcome measures were : back pain and sciatic pain intensity , disability , sick leaves , healthcare consumption , symptoms of depression , and beliefs of working ability after 2 years . Results . There were no statistically significant differences between the two treatment groups in main outcome measures just after rehabilitation , at 6- , at 12- , or 24-month follow-up . In both intervention arms , however , the before- and -after comparison showed favorable effects , and the effects were still maintained at 2 years follow-up . Conclusions . The results of this study indicate that semilight outpatient multidisciplinary rehabilitation program for female chronic low back pain patients does not offer incremental benefits when compared with rehabilitation carried out by a physiotherapist having a cognitive-behavioral way of administering the treatment OBJECTIVES To evaluate the effectiveness of a back school program in pain , functional status , quality of life , and in anxiety and depression in patients with non-specific low back pain . METHODS Sixty patients with low back pain were r and omized to an intervention and control group . The intervention group underwent a five-weekly back school program . The control group was seen in weekly medical visits , without educative approaches . Both groups took acetaminophen as analgesic medication . All subjects were evaluated by a blind physiotherapist after r and omization , 30 , 60 and 120 days . Roll and -Morris , SF-36 , STAI and Beck question naires , pain visual analogical scale and Schober 's test were applied . Non-steroidal anti-inflammatory drugs ( NSAID ) consumption was considered co-intervention . The statistical analyses were performed using Pearson 's Chi-Square analysis and Student 's t-test to compare the baseline characteristics of the groups and the analysis of variance ( ANOVA ) with repeated measures to assess changes inter/intra groups . RESULTS There were no significant differences in the baseline characteristics between the two groups . Fifty-five patients completed the study . The intervention group showed a significant improvement in the general health domain , assessed by SF-36 , and also in the reduction of acetaminophen and NSAID intake . There was no significant difference between the groups in pain , functional status , anxiety or depression . CONCLUSION The back school program was more effective than any educational intervention in general health status and in decreasing acetaminophen and NSAID intake . It was ineffective in the other quality of life domains , in pain , functional status , anxiety and depression OBJECTIVE To evaluate the effectiveness of the addition of back school to exercise and physical treatment modalities in relieving pain and improving the functional status of patients with chronic low back pain . DESIGN A r and omized controlled trial . PATIENTS A total of 146 patients with chronic low back pain were enrolled in the study . METHODS Subjects were divided into 2 groups : the back school group received exercise , physical treatment modalities and a back school programme ; and the control group received exercise and physical treatment modalities . Treatment efficacy was evaluated at the end of treatment and 3 months post-treatment , in terms of pain , measured with the Visual Analogue Scale , and functional status , measured with the Oswestry Low Back Pain Disability Question naire . RESULTS In both groups , Visual Analogue Scale and Oswestry Low Back Pain Disability Question naire were significantly reduced after therapy ( p < 0.01 ) , but the difference between the scores at the end of treatment and 3 months post-treatment was not significant . There was a significant improvement in Visual Analogue Scale and Oswestry Low Back Pain Disability Question naire in the back school group compared with the control group at the end of therapy and 3 months post-treatment ( p < 0.05 ) . CONCLUSION The addition of back school was more effective than exercise and physical treatment modalities alone in the treatment of patients with chronic low back pain Background Different interventions can reduce the burden of the chronic low back pain . One example is the use of a ' Back School Programme ' . This is a brief therapy that uses a health education method to empower participants through a procedure of assessment , education and skill development . This study aim ed to evaluate to what extent the programme could improve quality of life in those who suffer from the condition . Methods This was a r and omized controlled trial . One-hundred and two female patients with low back pain ( n = 102 ) were r and omly allocated into two groups , matched in terms of age , weight , education , socioeconomic status , occupation and some aspects of risk behavior . Group 1 ( back school group , n = 50 ) but not group 2 ( clinic group , n = 52 ) received the ' Back School Programme ' . Then quality of life using the Short Form Health Survey ( SF-36 ) was assessed at two time points : at baseline and at three months follow-up . The findings were compared both within and between two groups . Results The ' Back School Programme ' was effective in improving patients ' quality of life ; significant differences were found on all eight subscales of the SF-36 for group 1 . In the clinic group ( group 2 ) , improvement was observed on three scales ( bodily pain , vitality and mental health ) but these improvements were less than in group 1 . The mean improvement over all eight subscales of the SF-36 was significantly better for the ' Back School Programme ' group . Conclusion The ' Back School Programme ' is an effective intervention and might improve the quality of life over a period of 3 months in patients who experience chronic low back pain Intensive group training using principles of grade d activity has been proven to be effective in occupational care for workers with chronic low back pain . Objective of the study was to compare the effects of an intensive group training protocol aim ed at returning to normal daily activities and guideline physiotherapy for primary care patients with non-specific chronic low back pain . The study was design ed as pragmatic r and omised controlled trial with a setup of 105 primary care physiotherapists in 49 practice s and 114 patients with non-specific low back pain of more than 12 weeks duration participated in the study . In the intensive group training protocol exercise therapy , back school and operant-conditioning behavioural principles are combined . Patients were treated during 10 individual sessions along 20 group sessions . Usual care consisted of physiotherapy according to the Dutch guidelines for Low Back Pain . Main outcome measures were functional disability ( Rol and Morris disability question naire ) , pain intensity , perceived recovery and sick leave because of low back pain assessed at baseline and after 6 , 13 , 26 and 52 weeks . Both an intention-to-treat analysis and a per- protocol analysis were performed . Multilevel analysis did not show significant differences between both treatment groups on any outcome measures during the complete follow-up period , with one exception . After 26 weeks the protocol group showed more reduction in pain intensity than the guideline group , but this difference was absent after 52 weeks . We finally conclude that an intensive group training protocol was not more effective than usual physiotherapy for chronic low back pain Study Design . R and omized , single blind , controlled trial . Objective . To determine the efficacy of 2 components of musculoskeletal physiotherapy on chronic low back disorder . Summary of Background Data . Musculoskeletal physiotherapy encompasses many treatment methods , however , manual therapy and exercises to rehabilitate spinal stabilization are the most frequently used . Despite their popularity , scant evidence supports their use on subjects with chronic low back disorder . Methods . A total of 346 subjects were r and omized to manual therapy , a 10-week spinal stabilization rehabilitation program , or a minimal intervention control group . Data were collected at baseline , and 3 , 6 , 12 , and 24 months after intervention . Outcome measures recorded intensity of low back pain , disability , h and icap , medication , and quality of life . There were 4 main variables combined in a primary component analysis to form a single outcome measure ( i.e. , a measure of dysfunction ) . Results . The results indicated statistically significant improvements in favor of the spinal stabilization group at the 6-month stage in pain ( 65.9 % reduction in symptoms ) and dysfunction ( combined mean reduction of 134 , st and ard error 23.84 ) , and at the 1-year stage in medication ( 34.3 % reduction in medication ) , dysfunction ( combined mean reduction of 134 , st and ard error 18.2 ) , and disability ( mean difference in change 15.71 Oswestry Disability Index , 95 % confidence interval 19.3–10.01 ) . Conclusions . As a component of musculoskeletal physiotherapy , the spinal stabilization program is more effective than manually applied therapy or an education booklet in treating chronic low back disorder over time . Both manual therapy and the spinal stabilization program are significantly effective in pain reduction in comparison to an active control . To our knowledge and up until now , this result has not been shown in patients with chronic low back disorder OBJECTIVE To evaluate a progressive fitness programme for patients with chronic low back pain . DESIGN Single blind r and omised controlled trial . Assessment s were carried out before and after treatment by an observer blinded to the study and included a battery of vali date d measures . All patients were followed up by postal question naire six months after treatment . SETTING Physiotherapy department of orthopaedic hospital . SUBJECTS 81 patients with chronic low back pain referred from orthopaedic consultants for physiotherapy . The patients were r and omly allocated to a fitness programme or control group . INTERVENTION Both groups were taught specific exercises to carry out at home and referred to a back-school for education in back care . Patients allocated to the fitness class attended eight exercise classes over four weeks in addition to the home programme and backschool . RESULTS Significant differences between the groups were shown in the changes before and after treatment in scores on the Oswestry low back pain disability index ( P < 0.005 ) , pain reports ( sensory P < 0.05 and affective P < 0.005 ) , self efficacy reports ( P < 0.05 ) , and walking distance ( P < 0.005 ) . No significant differences between the groups were found by the general health question naire or question naire on pain locus of control . A benefit of about 6 percentage points on the disability index was maintained by patients in the fitness group at six months . CONCLUSION There is a role for supervised fitness programmes in the management of moderately disabled patients with chronic low back pain . Further clinical trials , however , need to be established in other centres to confirm these findings BACKGROUND AND OBJECTIVES The aim of this trial is to search effectiveness of specifically adapted exercise programs on its own and with low back school on pain , disability , trunk and quadriceps muscle strength , walking performance , spinal mobility , quality of life ( QOL ) , and depression in the patients with chronic low back pain ( CLBP ) . MATERIAL AND METHOD A total of 121 patients with definite CLBP were included in this study . The patients were r and omized into two groups . Group 1 ( n=60 ) was given exercises only and accepted as the control group . Group 2 ( n=61 ) received back school program and exercises . The exercise treatment was performed 3 days a week , for 3 months . The pain ( visual analog scale , VAS ) , disability ( Oswestry Disability Question naire , ODQ ) , walking performance ( 6 minute walking test , 6MWT ) , depression ( Beck Depression Inventory scores , BDI ) , and QOL ( Short Form 36 , SF-36 ) of all participants were evaluated . The trunk and knee muscle strength were measured with a h and held dynamometer . Patients were assessed at baseline ( BT ) , at the end of treatment ( AT ) , and at the six month follow-up ( F ) . RESULTS Statistically significant improvements were found between groups regarding all of the clinical parameters over time . Pain , disability , muscle strength , endurance , 6MWT , mobility , QOL , and depression of both groups also showed improvements AT . These improvements persisted at 6-months follow-ups ( P < 0.05 ) . There were statistically significant differences between the groups for pain , disability , muscle strength , endurance , 6MWT , QOL , and depression regarding the change scores between AT-BT test and F-BT test ( P < 0.05 ) . Group 2 improved more than group 1 except for mobility . CONCLUSION Exercise programs can be modified and used successfully in CLBP and this effect can be increased with addition of back school further . LEVEL OF EVIDENCE Diagnostic study Level-I-I ( prospect i ve study ) Inpatient and outpatient treatments were compared with a control intervention in 288 men and 168 women , aged 35 - 54 , who were at work , but suffered from chronic or recurrent low back pain . Physical measurements and back pain assessment s were carried out before the intervention and at a 3-month follow-up . Physical fitness improved most in the in patients , but the out patients did not differ from the controls . Correl \n Output:\n " }, { "from": "agent", "value": "Meta-analyses for pain scores and functional outcomes revealed statistical superiority of back schools vs no intervention for some comparisons but not others .\nNo meta- analysis was feasible for the comparison of back schools vs other active treatments .\nAdverse events were poorly reported so that no reliable conclusions regarding the safety of back schools can be drawn , although some limited reassurance in this regard may be derived from the fact that few adverse events and no serious adverse events were reported in the back school groups in the studies that did report on safety .\nOverall , the evidence base for the use of back schools to treat chronic low back pain is weak ; in nearly a half-century since back schools were first trialled , no unequivocal evidence of benefit has emerged" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective : To determine if ketoconazole , a thromboxane A2 synthetase inhibitor , given within the first 24 hrs after diagnosis and arrival in the intensive care unit ( ICU ) would decrease the frequency of adult respiratory distress syndrome in the septic patient population . Design : Prospect i ve , r and omized , double-blind , placeocontrolled study . Setting : Twelve-bed , surgical ICU in a university-affiliated hospital . Patients : Fifty-four consecutive patients admitted to the surgical ICU with the diagnosis of sepsis composed the study sample . Sepsis was defined as including two or more of the following signs in a patient with a systolic blood pressure of < 80 mm Hg or a systemic vascular resistance of < 800 dyne-sec/cm5 : a ) temperature ≥39 ° C or ≤35 ° C ; b ) white blood cell count of > 12,000 leukocytes , or ≤4000 leukocytes/μL , or ≥20 % immature cells ; c ) positive blood culture ; d ) known or strongly suspected source of infection from which a known pathogen was cultured . Interventions : Patients were r and omized to receive either ketoconazole ( 400 mg ) or placebo in a double-blind fashion as early as possible and in < 24 hrs after surgical ICU admission or after the diagnosis of sepsis was established . Measurements and Main Results : Adult respiratory distress syndrome ( ARDS ) was diagnosed if the following criteria were met : a ) intrapulmonary shunt of > 20 % , or a PaO2/Fio2 ratio of < 150 requiring ventilatory support for > 48 hrs ; b ) pulmonary artery occlusion pressure of < 18 nun Hg and no clinical signs of heart failure ; and c ) diffuse infiltrates on chest radiograph . Treatment result ed in significant ( p = .002 ) reduction in the frequency of ARDS compared with the placebo group , 64 % vs. 15 % in the ketoconazole treated group . The mortality rate was also reduced from 39 % in the placebo group to 15 % in the ketoconazole group ( p = .05 ) . A statistically significant reduction in ventilator and ICU days was not achieved . Conclusions : Ketoconazole ( 400 mg through the gastrointestinal tract ) given early in the septic course may prevent ARDS and decrease the mortality rate in high-risk , septic patients . ( Crit Care Med 1993 ; 21:1635–1642 Objective To determine whether caloric intake is associated with risk of nosocomial bloodstream infection in critically ill medical patients . Design Prospect i ve cohort study . Setting Urban , academic medical intensive care unit . Patients Patients were 138 adult patients who did not take food by mouth for ≥96 hrs after medical intensive care unit admission . Measurements Daily caloric intake was recorded for each patient . Participants subsequently were grouped into one of four categories of caloric intake : < 25 % , 25–49 % , 50–74 % , and ≥75 % of average daily recommended calories based on the American College of Chest Physicians guidelines . Simplified Acute Physiology Score II and serum albumin were measured on medical intensive care unit admission . Serum glucose ( average value and maximum value each day ) and route of feeding ( enteral , parenteral , or both ) were collected daily . Nosocomial bloodstream infections were identified by infection control surveillance methods . Main Results The overall mean ( ±sd ) daily caloric intake for all study participants was 49.4 ± 29.3 % of American College of Chest Physicians guidelines . Nosocomial bloodstream infection occurred in 31 ( 22.4 % ) participants . Bivariate Cox analysis revealed that receiving ≥25 % of recommended calories compared with < 25 % was associated with significantly lower risk of bloodstream infection ( relative hazard , 0.24 ; 95 % confidence interval , 0.10–0.60 ) . Simplified Acute Physiology Score II also was associated with risk of nosocomial bloodstream infection ( relative hazard , 1.27 ; 95 % confidence interval , 1.01–1.60 ) . Average daily serum glucose , admission serum albumin , time to initiating nutritional support , and route of nutrition did not affect risk of bloodstream infection . After adjustment for Simplified Acute Physiology Score II in a multivariable analysis , receiving ≥25 % of recommended calories was associated with a significantly lower risk of bloodstream infection ( relative hazard , 0.27 ; 95 % confidence interval , 0.11–0.68 ) . Conclusions In the context of reducing risk of nosocomial bloodstream infections , failing to provide ≥25 % of the recommended calories may be harmful . Higher caloric goals may be necessary to achieve other clinical ly important outcomes We examined the effect of ventilation strategy on lung inflammatory mediators in the presence and absence of a preexisting inflammatory stimulus . 55 Sprague-Dawley rats were r and omized to either intravenous saline or lipopolysaccharide ( LPS ) . After 50 min of spontaneous respiration , the lungs were excised and r and omized to 2 h of ventilation with one of four strategies : ( a ) control ( C ) , tidal volume ( Vt ) = 7 cc/kg , positive end expiratory pressure ( PEEP ) = 3 cm H2O ; ( b ) moderate volume , high PEEP ( MVHP ) , Vt = 15 cc/kg ; PEEP = 10 cm H2O ; ( c ) moderate volume , zero PEEP ( MVZP ) , Vt = 15 cc/kg , PEEP = 0 ; or ( d ) high volume , zero PEEP ( HVZP ) , Vt = 40 cc/kg , PEEP = 0 . Ventilation with zero PEEP ( MVZP , HVZP ) result ed in significant reductions in lung compliance . Lung lavage levels of TNFalpha , IL-1beta , IL-6 , IL-10 , MIP-2 , and IFNgamma were measured by ELISA . Zero PEEP in combination with high volume ventilation ( HVZP ) had a synergistic effect on cytokine levels ( e.g. , 56-fold increase of TNFalpha versus controls ) . Identical end inspiratory lung distention with PEEP ( MVHP ) result ed in only a three-fold increase in TNFalpha , whereas MVZP produced a six-fold increase in lavage TNFalpha . Northern blot analysis revealed a similar pattern ( C , MVHP < MVZP < HVZP ) for induction of c-fos mRNA . These data support the concept that mechanical ventilation can have a significant influence on the inflammatory/anti-inflammatory milieu of the lung , and thus may play a role in initiating or propagating a local , and possibly systemic inflammatory response OBJECTIVES Recent studies in animal models of sepsis-induced acute respiratory distress syndrome ( ARDS ) have shown that a low-carbohydrate , high-fat diet combining the anti-inflammatory and vasodilatory properties of eicosapentaenoic acid ( EPA ; fish oil ) , gamma-linolenic acid ( GLA ; borage oil ) ( EPA+GLA ) , and antioxidants improves lung microvascular permeability , oxygenation , and cardiopulmonary function and reduces proinflammatory eicosanoid synthesis and lung inflammation . These findings suggest that enteral nutrition with EPA+GLA and antioxidants may reduce pulmonary inflammation and may improve oxygenation and clinical outcomes in patients with ARDS . DESIGN Prospect i ve , multicentered , double-blind , r and omized controlled trial . SETTING Intensive care units of five academic and teaching hospitals in the United States . PATIENTS We enrolled 146 patients with ARDS ( as defined by the American-European Consensus Conference ) caused by sepsis/pneumonia , trauma , or aspiration injury in the study . INTERVENTIONS Patients meeting entry criteria were r and omized and continuously tube-fed either EPA+GLA or an isonitrogenous , isocaloric st and ard diet at a minimum caloric delivery of 75 % of basal energy expenditure x 1.3 for at least 4 - 7 days . MEASUREMENTS AND MAIN RESULTS Arterial blood gases were measured , and ventilator setting s were recorded at baseline and study days 4 and 7 to enable calculation of PaO2/FIO2 , a measure of gas exchange . Pulmonary neutrophil recruitment was assessed by measuring the number of neutrophils and the total cell count in bronchoalveolar lavage fluid at the same time points . Clinical outcomes were recorded . Baseline characteristics of 98 evaluable patients revealed that key demographic , physiologic , and ventilatory variables were similar at entry between both groups . Multiple bronchoalveolar lavages revealed significant decreases ( approximately 2.5-fold ) in the number of total cells and neutrophils per mL of recovered lavage fluid during the study with EPA+GLA compared with patients fed the control diet . Significant improvements in oxygenation ( PaO2/FIO2 ) from baseline to study days 4 and 7 with lower ventilation variables ( FIO2 , positive end-expiratory pressure , and minute ventilation ) occurred in patients fed EPA+GLA compared with controls . Patients fed EPA+GLA required significantly fewer days of ventilatory support ( 11 vs. 16.3 days ; p = .011 ) , and had a decreased length of stay in the intensive care unit ( 12.8 vs. 17.5 days ; p = .016 ) compared with controls . Only four of 51 ( 8 % ) patients fed EPA+GLA vs. 13 of 47 ( 28 % ) control patients developed a new organ failure during the study ( p = .015 ) . CONCLUSIONS The beneficial effects of the EPA+GLA diet on pulmonary neutrophil recruitment , gas exchange , requirement for mechanical ventilation , length of intensive care unit stay , and the reduction of new organ failures suggest that this enteral nutrition formula would be a useful adjuvant therapy in the clinical management of patients with or at risk of developing ARDS Objective : It has been shown in a two-center study that high positive end-expiratory pressure ( PEEP ) and low tidal volume ( LTV ) improved outcome in ARDS . However , that study involved patients with underlying diseases unique to the study area , was conducted at only two centers , and enrolled a small number of patients . We similarly hypothesized that a ventilatory strategy based on PEEP above the lower inflection point of the pressure volume curve of the respiratory system ( Pflex ) set on day 1 with a low tidal volume would result in improved outcome in patients with severe and persistent acute respiratory distress syndrome ( ARDS ) . Design : R and omized , controlled clinical trial . Setting : Network of eight Spanish multidisciplinary intensive care units ( ICUs ) under the acronym of ARIES ( Acute Respiratory Insufficiency : España Study ) . Patients : All consecutive patients admitted into participating Spanish ICUs from March 1999 to March 2001 with a diagnosis of ARDS were considered for the study . If 24 hrs after meeting ARDS criteria , the Pao2/Fio2 remained ≤200 mm Hg on st and ard ventilator setting s , patients were r and omized into two groups : control and Pflex/LTV . Interventions : In the control group , tidal volume was 9–11 mL/kg of predicted body weight ( PBW ) and PEEP ≥5 cm H2O . In the Pflex/LTV group , tidal volume was 5–8 mL/kg PBW and PEEP was set on day 1 at Pflex + 2 cm H2O . In both groups , Fio2 was set to maintain arterial oxygen saturation > 90 % and Pao2 70–100 mm Hg , and respiratory rate was adjusted to maintain Paco2 between 35 and 50 mm Hg . Measurements and Main Results : The study was stopped early based on an efficacy stopping rule as described in the methods . Of 103 patients who were enrolled ( 50 control and 53 Pflex ) , eight patients ( five in control , three in Pflex ) were excluded from the final evaluation because the r and om group assignment was not performed in one center according to protocol . Main outcome measures were ICU and hospital mortality , ventilator-free days , and nonpulmonary organ dysfunction . ICU mortality ( 24 of 45 [ 53.3 % ] vs. 16 of 50 [ 32 % ] , p = .040 ) , hospital mortality ( 25 of 45 [ 55.5 % ] vs. 17 of 50 [ 34 % ] , p = .041 ) , and ventilator-free days at day 28 ( 6.02 ± 7.95 in control and 10.90 ± 9.45 in Pflex/LTV , p = .008 ) all favored Pflex/LTV . The mean difference in the number of additional organ failures postr and omization was higher in the control group ( p < .001 ) . Conclusions : A mechanical ventilation strategy with a PEEP level set on day 1 above Pflex and a low tidal volume compared with a strategy with a higher tidal volume and relatively low PEEP has a beneficial impact on outcome in patients with severe and persistent ARDS OBJECTIVE To determine whether the implementation of a nutritional management protocol in the ICU leads to the increased use of enteral nutrition , earlier feeding , and improved clinical outcomes in patients . DESIGN Prospect i ve evaluation of critically ill patients before and after the introduction of an \n Output:\n " }, { "from": "agent", "value": "Grasso S , Stripoli T , De Michele M , et al. ARDSnet ventilatory protocol and alveolar hyperinflation : role of positive endexpiratory pressure ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND The results of FASTACT , a r and omised , placebo-controlled , phase 2 study , showed that intercalated chemotherapy and erlotinib significantly prolonged progression-free survival ( PFS ) in patients with advanced non-small-cell lung cancer . We undertook FASTACT-2 , a phase 3 study in a similar patient population . METHODS In this phase 3 trial , patients with untreated stage IIIB/IV non-small-cell lung cancer were r and omly assigned in a 1:1 ratio by use of an interactive internet response system with minimisation algorithm ( stratified by disease stage , tumour histology , smoking status , and chemotherapy regimen ) to receive six cycles of gemcitabine ( 1250 mg/m(2 ) on days 1 and 8 , intravenously ) plus platinum ( carboplatin 5 × area under the curve or cisplatin 75 mg/m(2 ) on day 1 , intravenously ) with intercalated erlotinib ( 150 mg/day on days 15 - 28 , orally ; chemotherapy plus erlotinib ) or placebo orally ( chemotherapy plus placebo ) every 4 weeks . With the exception of an independent group responsible for monitoring data and safety monitoring board , everyone outside the interactive internet response system company was masked to treatment allocation . Patients continued to receive erlotinib or placebo until progression or unacceptable toxicity or death , and all patients in the placebo group were offered second-line erlotinib at the time of progression . The primary endpoint was PFS in the intention-to-treat population . This trial is registered with Clinical Trials.gov , number NCT00883779 . FINDINGS From April 29 , 2009 , to Sept 9 , 2010 , 451 patients were r and omly assigned to chemotherapy plus erlotinib ( n=226 ) or chemotherapy plus placebo ( n=225 ) . PFS was significantly prolonged with chemotherapy plus erlotinib versus chemotherapy plus placebo ( median PFS 7·6 months [ 95 % CI 7·2 - 8·3 ] , vs 6·0 months [ 5·6 - 7·1 ] , hazard ratio [ HR ] 0·57 [ 0·47 - 0·69 ] ; p<0·0001 ) . Median overall survival for patients in the chemotherapy plus erlotinib and chemotherapy plus placebo groups was 18·3 months ( 16·3 - 20·8 ) and 15·2 months ( 12·7 - 17·5 ) , respectively ( HR 0·79 [ 0·64 - 0·99 ] ; p=0·0420 ) . Treatment benefit was noted only in patients with an activating EGFR gene mutation ( median PFS 16·8 months [ 12·9 - 20·4 ] vs 6·9 months [ 5·3 - 7·6 ] , HR 0·25 [ 0·16 - 0·39 ] ; p<0·0001 ; median overall survival 31·4 months [ 22·2-undefined ] , vs 20·6 months [ 14·2 - 26·9 ] , HR 0·48 [ 0·27 - 0·84 ] ; p=0·0092 ) . Serious adverse events were reported by 76 ( 34 % ) of 222 patients in the chemotherapy plus placebo group and 69 ( 31 % ) of 226 in the chemotherapy plus erlotinib group . The most common grade 3 or greater adverse events were neutropenia ( 65 [ 29 % ] patients and 55 [ 25 % ] , respectively ) , thrombocytopenia ( 32 [ 14 % ] and 31 [ 14 % ] , respectively ) , and anaemia ( 26 [ 12 % ] and 21 [ 9 % ] , respectively ) . INTERPRETATION Intercalated chemotherapy and erlotinib is a viable first-line option for patients with non-small-cell lung cancer with EGFR mutation-positive disease or selected patients with unknown EGFR mutation status . FUNDING F Hoffmann-La Roche A quantitative systematic review , or meta- analysis , uses statistical methods to combine the results of multiple studies . Meta-analyses have been done for systematic review s of therapeutic trials , diagnostic test evaluations , and epidemiologic studies . Although the statistical methods involved may at first appear to be mathematically complex , their purpose is simple : They are trying to answer four basic questions . Are the results of the different studies similar ? To the extent that they are similar , what is the best overall estimate ? How precise and robust is this estimate ? Finally , can dissimilarities be explained ? This article provides some guidance in underst and ing the key technical aspects of the quantitative approach to these questions . We have avoided using equations and statistical notations ; interested readers will find implementations of the described methods in the listed references . We focus here on the quantitative synthesis of reports of r and omized , controlled , therapeutic trials because far more meta-analyses on therapeutic studies than on other types of studies have been published . For practical reasons , we present a stepwise description of the tasks that are performed when statistical methods are used to combine data . These tasks are 1 ) deciding whether to combine data and defining what to combine , 2 ) evaluating the statistical heterogeneity of the data , 3 ) estimating a common effect , 4 ) exploring and explaining heterogeneity , 5 ) assessing the potential for bias , and 6 ) presenting the results . Deciding Whether To Combine Data and Defining What To Combine By the time one performs a quantitative synthesis , certain decisions should already have been made about the formulation of the question and the selection of included studies . These topics were discussed in two previous articles in this series [ 1 , 2 ] . Statistical tests can not compensate for lack of common sense , clinical acumen , and biological plausibility in the design of the protocol of a meta- analysis . Thus , a reader of a systematic review should always address these issues before evaluating the statistical methods that have been used and the results that have been generated . Combining poor- quality data , overly biased data , or data that do not make sense can easily produce unreliable results . The data to be combined in a meta- analysis are usually either binary or continuous . Binary data involve a yes/no categorization ( for example , death or survival ) . Continuous data take a range of values ( for example , change in diastolic blood pressure after antihypertensive treatment , measured in mm Hg ) . When one is comparing groups of patients , binary data can be summarized by using several measures of treatment effect that were discussed earlier in this series [ 3 ] . These measures include the risk ratio ; the odds ratio ; the risk difference ; and , when study duration is important , the incidence rate . Another useful clinical measure , the number needed to treat ( NNT ) , is derived from the inverse of the risk difference [ 3 ] . Treatment effect measures , such as the risk ratio and the odds ratio , provide an estimate of the relative efficacy of an intervention , whereas the risk difference describes the intervention 's absolute benefit . The various measures of treatment effect offer complementary information , and all should be examined [ 4 ] . Continuous data can be summarized by the raw mean difference between the treatment and control groups when the treatment effect is measured on the same scale ( for example , diastolic blood pressure in mm Hg ) , by the st and ardized mean difference when different scales are used to measure the same treatment effect ( for example , different pain scales being combined ) , or by the correlation coefficients between two continuous variables [ 5 ] . The st and ardized mean difference , also called the effect size , is obtained by dividing the difference between the mean in the treatment group and the mean in the control group by the SD in the control group . Evaluating the Statistical Heterogeneity of the Data This step is intended to answer the question , Are the results of the different studies similar ( homogeneous ) ? It is important to answer this question before combining any data . To do this , one must calculate the magnitude of the statistical diversity ( heterogeneity ) of the treatment effect that exists among the different sets of data . Statistical diversity can be thought of as attributable to one or both of two causes . First , study results can differ because of r and om sampling error . Even if the true effect is the same in each study , the results of different studies would be expected to vary r and omly around the true common fixed effect . This diversity is called the within- study variance . Second , each study may have been drawn from a different population , depending on the particular patients chosen and the interventions and conditions unique to the study . Therefore , even if each study enrolled a large patient sample , the treatment effect would be expected to differ . These differences , called r and om effects , describe the between- study variation with regard to an overall mean of the effects of all of the studies that could be undertaken . The test most commonly used to assess the statistical significance of between- study heterogeneity is based on the chi-square distribution [ 6 ] . It provides a measure of the sum of the squared differences between the results observed and the results expected in each study , under the assumption that each study estimates the same common treatment effect . A large total deviation indicates that a single common treatment effect is unlikely . Any pooled estimate calculated must account for the between- study heterogeneity . In practice , this test has low sensitivity for detecting heterogeneity , and it has been suggested that a liberal significance level , such as 0.1 , should be used [ 6 ] . Estimating a Common Effect The questions that this step tries to answers are , 1 ) To the extent that data are similar , what is their best common point estimate of a therapeutic effect , and 2 ) how precise is this estimate ? The mathematical process involved in this step generally involves combining ( pooling ) the results of different studies into an overall estimate . Compared with the results of individual studies , pooled results can increase statistical power and lead to more precise estimates of treatment effect . Each study is given a weight according to the precision of its results . The rationale is that studies with narrow CIs should be weighted more heavily than studies with greater uncertainty . The precision is generally expressed by the inverse of the variance of the estimate of each study . The variance has two components : the variance of the individual study and the variance between different studies . When the between- study variance is found to be or assumed to be zero , each study is simply weighted by the inverse of its own variance , which is a function of the study size and the number of events in the study . This approach characterizes a fixed-effects model , as exemplified by the Mantel-Haenszel method [ 7 , 8 ] or the Peto method [ 9 ] for dichotomous data . The Peto method has been particularly popular in the past . It has the advantage of simple calculation ; however , although it is appropriate in most cases , it may introduce large biases if the data are unbalanced [ 10 , 11 ] . On the other h and , r and om-effects models also add the between- study variance to the within- study variance of each individual study when the pooled mean of the r and om effects is calculated . The r and om-effects model most commonly used for dichotomous data is the DerSimonian and Laird estimate of the between- study variance [ 12 ] . Fixed- and r and om-effects models for continuous data have also been described [ 13 ] . Pooled results are generally reported as a point estimate and CI , typically a 95 % CI . Other quantitative techniques for combining data , such as the Confidence Profile Method [ 14 ] , use Bayesian methods to calculate posterior probability distributions for effects of interest . Bayesian statistics are based on the principle that each observation or set of observations should be viewed in conjunction with a prior probability describing the prior knowledge about the phenomenon of interest [ 15 ] . The new observations alter this prior probability to generate a posterior probability . Traditional meta- analysis assumes that nothing is known about the magnitude of the treatment effect before r and omized trials are performed . In Bayesian terms , the prior probability distribution is noninformative . Bayesian approaches may also allow the incorporation of indirect evidence in generating prior distributions [ 14 ] and may be particularly helpful in situations in which few data from r and omized studies exist [ 16 ] . Bayesian analyses may also be used to account for the uncertainty introduced by estimating the between- study variance in the r and om-effects model , leading to more appropriate estimates and predictions of treatment efficacy [ 17 ] . Exploring and Explaining Heterogeneity The next important issue is whether the common estimate obtained in the previous step is robust . Sensitivity analyses determine whether the common estimate is influenced by changes in the assumptions and in the protocol for combining the data . A comparison of the results of fixed- and r and om-effects models is one such sensitivity analysis [ 18 ] . Generally , the r and om-effects model produces wider CIs than does the fixed-effects model , and the level of statistical significance may therefore be different depending on the model used . The pooled point estimate per se is less likely to be affected , although exceptions are possible [ 19 ] . Other sensitivity analyses may include the examination of the residuals and the chi-square components [ 13 ] and assessment of the effect of deleting each study in turn . Statistically significant results that depend on a single study may require further exploration . Cumulative Meta- Analysis PURPOSE To determine the proportion of lung adenocarcinomas from East Asian never-smokers who harbor known oncogenic driver mutations . PATIENTS AND METHODS In this surgical series , 52 resected lung adenocarcinomas from never-smokers ( < 100 cigarettes in a lifetime ) at a single institution ( Fudan University , Shanghai , China ) were analyzed concurrently for mutations in EGFR , KRAS , NRAS , HRAS , HER2 , BRAF , ALK , PIK3CA , TP53 and LKB1 . RESULTS Forty-one tumors harbored EGFR mutations , three harbored EML4-ALK fusions , two harbored HER2 insertions , and one harbored a KRAS mutation . All mutations were mutually exclusive . Thus , 90 % ( 47 of 52 ; 95 % CI , 0.7896 to 0.9625 ) of lung adenocarcinomas from never-smokers were found to harbor well-known oncogenic mutations in just four genes . No BRAF , NRAS , HRAS , or LKB1 mutations were detected , while \n Output:\n " }, { "from": "agent", "value": "Conclusions This meta- analysis suggests that EGFR mutation is an important predictive factor linked to improved OS for NSCLC patients with brain metastases .\nIt can serve as a useful index in the prognostic assessment of NSCLC patients with brain metastases" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: A r and omized , open clinical trial was performed to compare azithromycin and amoxycillin/clavulanate potassium in children with acute otitis media with effusion . Patients were allocated to therapy with azithromycin ( 10 mg/kg once daily for 3 days ) or amoxycillin/clavulanate potassium ( 40 mg/kg/day divided into three equal doses for 10 days ) . Clinical examination and tympanometric evaluation were performed at baseline , and at day 3 to 5 , day 10 to 14 , day 28 to 30 and day 55 to 60 after the initiation of therapy . Tympanocentesis fluid cultures were collected at enrolment , and urine and blood sample s were obtained at baseline and at day 10 to 11 . Of 100 patients enrolled , 92 were considered evaluable . Middle ear cultures were positive in 53.2 % of the patients ; the most common pathogens were Streptococcus pneumoniae ( 33 % ) and Haemophilus influenzae ( 33 % ) . The response was satisfactory in 47 ( 100 % ) patients treated with azithromycin and 42 ( 95.4 % ) patients receiving A/C. Rates of persistence of middle ear effusion were comparable . Nausea and loose stools were more common in children treated with amoxycillin/clavulanate potassium ( P < or = 0.02 ) . Based on the comparable efficacy noted in this study , the lower incidence of side-effects and the convenience of a shorter duration of treatment , azithromycin represents an attractive therapeutic alternative to amoxycillin/clavulanate potassium and should be further evaluated in larger-scale clinical trials including patients with penicillin-resistant organisms A double-blind controlled trial of cefroxadine ( CXD ) 250 mg t.i.d . was undertaken to objective ly evaluate its safety and effectiveness in the treatment of acute suppurative otitis media and acute exacerbation of chronic suppurative otitis media , using cephalexin ( CEX ) 250 mg q.i.d . as a control drug , and the following results were obtained . In the treatment of acute suppurative otitis media , the 2 drugs produced almost equal outcomes , showing no significant difference in assessment s of both overall effects and usefulness . In the treatment of acute exacerbation of chronic suppurative otitis media , the 2 drugs exhibited no significant difference as well in overall effects by Wilcoxon 's two- sample test . However , the CEX group had significantly more nonresponsive patients , i.e. 35.5 % as compared with 9.7 % of the CXD group ( chi 2-test , P less than 0.05 ) . In the assessment of clinical usefulness as well , no significant difference was observed between the 2 groups . In the assessment of overall effects based on the patients whose isolated organisms were sensitive to the drugs , CEX group had more patients not responding to the treatment of acute exacerbation of chronic suppurative otitis media ( chi 2-test , P less than 0.05 ) . Bacteriological effects were not significantly different between the 2 drugs in both acute suppurative otitis media and acute exacerbation of chronic suppurative otitis media . Overall safety rating was not significantly different between the 2 drugs . Side effects occurred as the symptoms of digestive organ in 2 patients each in both groups ( equally an incidence of 2.6 % ) . As for the improvement of each symptom after treatment ( assessed on day 3 ) , CXD was superior in the improvement rate of otorrhea volume as the main symptom of acute exacerbation of chronic suppurative otitis media , while CEX was superior in that of otoobstruction feeling . From the above findings , it is presumed that CXD is a safe drug which can exhibit equal or superior therapeutic effects to CEX in the treatment of acute suppurative otitis media and acute exacerbation of chronic suppurative otitis media , at 3/4 of the CEX dose level An open multicentre study was conducted in 484 children between the ages of 6 months and 12 years with otitis media to compare the efficacy , the safety and the tolerance of once-daily azithromycin given for three days versus thrice-daily amoxicillin/clavulanic acid ( CA ) given for ten days . A satisfactory response ( cure plus improvement ) was noted 10 to 14 days after the start of treatment in 199 of 215 ( 92.6 % ) azithromycin-treated children and in 186 of 198 ( 93.9 % ) amoxicillin/CA-treated children . The relationship between treatment and clinical response was independent of chronicity of infection and the presence or absence of a perforated eardrum . Improvement in signs and symptoms of otitis media occurred significantly more rapidly in the children treated with azithromycin . Treatment-related or possibly treatment-related adverse events were recorded in 11 of 243 ( 4.5 % ) azithromycin-treated patients and in 20 of 240 ( 8.3 % ) treated with amoxicillin/CA . No patients in the azithromycin treatment group were withdrawn from treatment , but six amoxicillin/CA patients , including two < 2 years of age , discontinued treatment prematurely because of adverse events ; the difference between treatment groups was statistically significant ( p=0.0146 ) . It is concluded that azithromycin given as an oral suspension once daily for three days is as safe and effective as amoxicillin/CA given thrice daily for ten days in the treatment of children with otitis media ABSTRACT Infants and young children , especially those in day care , are at risk for recurrent or persistent acute otitis media ( AOM ) . There are no data on oral alternatives to high-dose amoxicillin-clavulanate for treating AOM in these high-risk patients . In this double-blind , double-dummy multicenter clinical trial , we compared a novel , high-dose azithromycin regimen with high-dose amoxicillin-clavulanate for treatment of children with recurrent or persistent AOM . Three hundred four children were r and omized ; 300 received either high-dose azithromycin ( 20 mg/kg of body weight once a day for 3 days ) or high-dose amoxicillin-clavulanate ( 90 mg/kg divided twice a day for 10 days ) . Tympanocentesis was performed at baseline ; clinical response was assessed at day 12 to 16 and day 28 to 32 . Two-thirds of patients were aged ≤2 years . A history of recurrent , persistent , or recurrent plus persistent AOM was noted in 67 , 18 , and 14 % of patients , respectively . Pathogens were isolated from 163 of 296 intent-to-treat patients ( 55 % ) . At day 12 to 16 , clinical success rates for azithromycin and amoxicillin-clavulanate were comparable for all patients ( 86 versus 84 % , respectively ) and for children aged ≤2 years ( 85 versus 79 % , respectively ) . At day 28 to 32 , clinical success rates for azithromycin were superior to those for amoxicillin-clavulanate for all patients ( 72 versus 61 % , respectively ; P = 0.047 ) and for those aged ≤2 years ( 68 versus 51 % , respectively ; P = 0.017 ) . Per-pathogen clinical efficacy against Streptococcus pneumoniae and Haemophilus influenzae was comparable between the two regimens . The rates of treatment-related adverse events for azithromycin and amoxicillin-clavulanate were 32 and 42 % , respectively ( P = 0.095 ) . Corresponding compliance rates were 99 and 93 % , respectively ( P = 0.018 ) . These data demonstrate the efficacy and safety of high-dose azithromycin for treating recurrent or persistent AOM In r and omized , double-blind trials of antibiotic therapy for acute otitis media that determined both clinical and bacteriologic outcomes , clinical success rates were ( 93 % ) 236 of 253 for patients with bacteriologic success , ( 62 % ) 25 of 40 for those with bacteriologic failure , and ( 80 % ) 124 of 155 for those with nonbacterial acute otitis media . These rates were used to calculate the effectiveness of three strategies for assessing drug efficacy : ( 1 ) tympanocentesis and culture before and during therapy ( bacteriologic efficacy ) , ( 2 ) tympanocentesis before therapy and assessment of clinical efficacy in bacterial acute otitis media , and ( 3 ) no tympanocentesis and assessment of clinical efficacy in clinical ( total ) acute otitis media . For a drug with a bacteriologic efficacy of 100 % , calculated clinical efficacy was 93 % for bacterial acute otitis media and 89 % for clinical acute otitis media . For a drug with bacteriologic efficacy of 27 % , a rate consistent with no antibacterial therapy , efficacy was 71 % for bacterial acute otitis media and 74 % for clinical acute otitis media . We conclude that if efficacy is measured by symptomatic response , drugs with excellent antibacterial activity will appear less efficacious than they really are and drugs with poor antibacterial activity will appear more efficacious than they really are . The predominant phenomenon is that drugs with poor antibacterial activity will appear to be clinical ly effective in the treatment of acute otitis media Abstract Objective To assess the efficacy of three days versus five days of treatment with oral amoxicillin for curing non-severe pneumonia in children . Design R and omised , double blind , placebo controlled multicentre trial . Setting Outpatient departments of seven referral hospitals in India . Participants 2188 children aged 2 - 59 months , 1095 given three days of treatment and 1093 given five days . Intervention Oral amoxicillin 31 - 54 mg/kg/day in three divided doses . Main outcome measures Treatment failure : defined as development of chest indrawing , convulsions , drowsiness , or inability to drink at any time ; respiratory rate above age specific cut points on day 3 or later ; or oxygen saturation by pulse oximetry < 90 % on day 3 . Results The clinical cure rates with three days and five days of treatment were 89.5 % and 89.9 % , respectively ( absolute difference 0.4 ( 95 % confidence interval - 2.1 to 3.0 ) ) . Adherence to treatment regimen was 94 % and 85 % for three day and five day treatments , respectively . Loss to follow up was 5.4 % by day 5 . There were no deaths , 41 hospitalisations , and 36 minor adverse reactions . There were 225 ( 10.3 % ) clinical failures and 106 ( 5.3 % ) relapses , and rates were similar in both treatments . At enrolment , 513 ( 23.4 % ) children tested positive for respiratory syncytial virus , and Streptococcus pneumoniae and Haemophilus influenzae were isolated from the nasopharynx in 878 ( 40.4 % ) and 496 ( 22.8 % ) children , respectively . Clinical failure was associated with isolation of respiratory syncytial virus ( adjusted odds ratio 1.95 ( 95 % confidence interval 1.0 to 3.8 ) ) , excess respiratory rate of > 10 breaths/minute ( 2.89 ( 1.83 to 4.55 ) ) , and non-adherence with treatment at day 5 ( 11.57 ( 7.4 to 18.0 ) ) . Conclusions Treatment with oral amoxicillin for three days was as effective as for five days in children with non-severe pneumonia Abstract Two hundred and fifteen children aged 4 months–6 years with acute otitis media ( AOM ) were r and omized to be treated either by a single i.m . injection of ceftriaxone , 50 mg/kg , with a second dose in the event of unsatisfactory response after 48 h or a history of recurrent AOM ( 109 patients ) or amoxicillin clavulanate 12.5 mg tid ( 106 patients ) . The failure rate was similar in children treated by ceftriaxone and amoxicillin clavulanate , 4.6 % and 4.7 % , respectively ( st and ard error for intergroup difference −2.87 % , 95 % confidence interval −5.62 % to 5.87 % ) . No significant differences between the groups were found in the dynamics of the resolution of the acute symptomatology , otoscopy findings , relapse rate at 30 days or tympanographic evidence of middle ear effusion at the scheduled visits on days 30 , 60 and 90 . Recurrence of AOM between days 31 and 90 was observed significantly in more children treated with amoxicillin clavulanate than with ceftriaxone – 25 out of 84 ( 29.4 % ) versus 11 out of 81 ( 13.6 % ) ( P=0.012 ) . Conclusion Ceftriaxone injection(s ) is as efficient at least as 10-day oral amoxicillin clavulanate for \n Output:\n " }, { "from": "agent", "value": "Conclusion There is no evidence of an increased risk of treatment failure with short course of antibiotics for acute otitis media .\nAmong the short-course regimens , azithromycin use was associated with a lower risk of treatment failure while short-acting oral antibiotics and parenteral ceftriaxone may be associated with a higher risk of treatment failure" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Persons with human immunodeficiency virus ( HIV ) infection are at risk for premature cardiovascular disease ( CVD ) . Predictors of atherosclerotic disease progression in contemporary patients have not been well described . METHODS Using data from a prospect i ve observational cohort of adults infected with HIV ( Study to Underst and the Natural History of HIV/AIDS in the Era of Effective Therapy ) , we assessed common carotid artery intima-media thickness ( CIMT ) at baseline and year 2 by ultrasound . We examined HIV-associated predictors of CIMT progression after adjusting for age , sex , race/ethnicity , body mass index , smoking , hypertension , diabetes , low-density lipoprotein cholesterol level , and baseline CIMT using linear regression . RESULTS Among 389 participants ( median age at baseline , 42 years ; male sex , 77 % ; median CD4 + cell count at baseline , 485 cells/mm³ ; 78 % receiving antiretroviral therapy ) , the median 2-year CIMT change was 0.016 mm ( interquartile range , -0.003 to 0.033 mm ; P < .001 ) . Lesser CIMT progression was associated with a suppressed viral load at baseline ( -0.009 mm change ; P = .015 ) and remaining virologically suppressed throughout follow-up ( -0.011 mm change ; P < .001 ) . After adjusting for additional risk factors and a suppressed viral load during follow-up , nonnucleoside reverse transcriptase inhibitor versus protease inhibitor exposure was associated with lesser CIMT progression ( -0.011 mm change ; P = .02 ) . CONCLUSIONS Suppressing HIV replication below clinical thresholds was associated with less progression of atherosclerosis . The proatherogenic mechanisms of HIV replication and the net CVD benefit of different antiretroviral drugs should be a focus of future research BACKGROUND Human immunodeficiency virus (HIV)-infected patients are at increased risk of cardiovascular disease , which may be related to chronic inflammation and endothelial dysfunction despite virological control with antiretroviral therapy . The relationship between carotid intima-media thickness ( IMT ) , a surrogate marker for cardiovascular disease , proinflammatory cytokines , and endothelial activation markers has not been fully explored in HIV-infected patients who are receiving antiretroviral therapy . METHODS We conducted a prospect i ve , cross-sectional , observational study of treated HIV-infected patients and healthy control subjects to evaluate the relationship between carotid IMT , proinflammatory cytokines , endothelial activation biomarkers , and metabolic parameters in treated HIV-infected patients , compared with healthy control subjects . RESULTS We enrolled 73 HIV-infected patients and 21 control subjects . Common carotid artery and internal carotid artery IMT measurements , as well as tumor necrosis factor-alpha , high-sensitivity C-reactive protein , interleukin-6 , myeloperoxidase , and soluble vascular cell adhesion molecule-1 levels were higher in the HIV-infected group . High-sensitivity C-reactive protein was the only biomarker that was positively correlated with carotid IMT in both groups . In the HIV-infected group , soluble vascular cell adhesion molecule-1 was positively correlated with all inflammatory cytokine levels . In multiple regression analysis , soluble vascular cell adhesion molecule-1 , myeloperoxidase , and tumor necrosis factor-alpha levels were all associated with internal carotid artery IMT in the HIV-infected group , whereas age was associated with both common carotid artery and internal carotid artery IMT . CONCLUSIONS Enhanced endothelial activation , inflammation , and increased carotid IMT occur in HIV-infected patients despite antiretroviral therapy . Inflammatory markers are associated with endothelial activation , and both are associated with internal carotid artery IMT , supporting a potential role of inflammation in endothelial activation and cardiovascular disease in HIV infection OBJECTIVE Combined antiretroviral therapy ( cART ) has significantly improved the survival rate and quality of life for HIV-infected subjects , but it contributes to the development of metabolic complications including coronary artery disease ( CAD ) . Recent studies have reported that high plasma levels of the soluble receptor for advanced glycation end products ( sRAGE ) were associated with a lower incidence of CAD in non-HIV infected patients . However , there has been no report of an association of sRAGE and sub clinical carotid atherosclerosis in HIV-infected patients receiving cART . METHODS We examined the association of circulating sRAGE in HIV-infected patients with carotid intima-media thickness ( IMT ) and other metabolic variables . We prospect ively enrolled 76 HIV-infected patients receiving cART for ≥ 6 months . RESULTS sRAGE had a significantly negative correlation with body mass index ( r = -0.324 , p = 0.005 ) , waist-to-hip ratio ( r = -0.335 , p = 0.003 ) , systolic blood pressure ( BP ) ( r=-0.359 , p=0.002 ) , diastolic BP ( r = -0.343 , p = 0.004 ) , total cholesterol ( r = -0.240 , p = 0.037 ) , low-density lipoprotein-cholesterol ( r=-0.284 , p=0.024 ) , log(homeostasis model assessment of insulin resistance [ HOMA-IR ] ) ( r = -0.380 , p = 0.002 ) and carotid IMT including max-IMT and mean-IMT ( r = -0.358 , p = 0.001 and r = -0.329 , p = 0.004 , respectively ) . By the use of multiple stepwise regression analyses , systolic BP ( p=0.001 ) and log[HOMA-IR ] ( p = 0.001 ) remained significant independently . CONCLUSIONS These results suggest that sRAGE may have a protective effect against sub clinical atherosclerosis by preventing inflammatory responses mediated by the activation of cell surface RAGE in HIV-infected patients receiving cART BACKGROUND Marked changes in the prevalence of noncommunicable diseases such as obesity , diabetes , and cardiovascular disease have occurred in developed and developing countries in recent decades . The overarching aim of the study is to examine the relationship of societal influences on human lifestyle behaviors , cardiovascular risk factors , and incidence of chronic noncommunicable diseases . METHODS The Prospect i ve Urban Rural Epidemiology ( PURE ) study is a large-scale epidemiological study that plans to recruit approximately 140,000 individuals residing in > 600 communities in 17 low- , middle- , and high-income countries around the world . Individual data collection includes medical history , lifestyle behaviors ( physical activity and dietary profile ) , blood collection and storage for biochemistry and future genetic analysis , electrocardiogram , and anthropometric measures . In addition , detailed information is being collected with respect to 4 environmental domains of interest-the built environment , nutrition and associated food policy , psychosocial/socioeconomic factors , and tobacco environment . A minimum follow-up of 10 years is currently planned . RESULTS This report describes the design , justification , and methodology of the PURE study . The PURE study has been recruiting since 2002 and has enrolled 139,506 individuals by March 31 , 2009 . CONCLUSIONS The PURE study builds on the work and experience gained through conduct of the INTERHEART study . Its design and extensive data collection are geared toward addressing major questions on causation and development of the underlying determinants of cardiovascular disease in population s at varying stages of epidemiologic transition Rosiglitazone may be useful for the treatment of antiretroviral therapy-associated lipoatrophy , but an association with cardiovascular disease ( CVD ) has been question ed in diabetics . We evaluated rosiglitazone 's effect on surrogate markers of CVD in HIV-infected individuals with lipoatrophy . HIV(+ ) patients with lipoatrophy on thymidine-sparing regimens were r and omized to rosiglitazone vs. placebo for 48 weeks . We serially assessed carotid IMT , fasting metabolic profiles , tumor necrosis factor (TNF)-α , soluble receptors ( sTNFRI and II ) , interleukin (IL)-6 , high-sensitivity C-reactive protein ( hsCRP ) , myeloperoxidase ( MPO ) , and endothelial activation markers [ von Willebr and factor ( vWF ) , soluble intercellular cell adhesion molecules-1 ( sICAM-1 ) , and vascular cell adhesion molecules-1 ( sVCAM-1 ) ] . Seventy-one subjects enrolled : 17 % were female and 51%were white . Baseline characteristics were similar between groups except for higher total cholesterol in the placebo group ( p = 0.04 ) . At 48 weeks , common carotid artery ( CCA ) IMT changed significantly ( p ≤ 0.05 ) within but not between the groups ( p = 0.36 ) : the median ( IQR ) increase was 0.10 ( 0.05 , 0.25 ) mm and 0.15 ( 0 , 0.25 ) mm in the rosiglitazone and placebo groups , respectively . hsCRP , sTNFRI and II , sVCAM-1 , and vWF changed significantly ( p ≤ 0.02 ) within but not between groups . Total cholesterol increased significantly in the rosiglitazone group ( p = 0.008 ) . In our study of virologically controlled subjects with lipoatrophy , rosiglitazone did not independently increase carotid IMT , endothelial activation , and inflammatory cytokines Chronic HIV infection is associated with increased risk of cardiovascular disease ( CVD ) , including in patients with virological suppression . Persistent innate immune activation may contribute to the development of CVD via activation of monocytes in these patients . We investigated whether changes in monocyte phenotype predict sub clinical atherosclerosis in virologically suppressed HIV-positive individuals with low cardiovascular risk . We enroled 51 virologically suppressed HIV-positive individuals not receiving protease inhibitors or statins and 49 age-matched uninfected controls in this study . Carotid artery intima-media thickness ( cIMT ) was used as a surrogate marker for CVD , and traditional risk factors , including Framingham risk scores , were recorded . Markers of monocyte activation ( CD14 , CD16 , CCR2 , CX3CR1 , CD38 , HLA-DR and CD11b ) were measured in whole-blood sample s by flow cytometry . Associations were assessed using univariate and multivariate median regressions . Median cIMT was similar between HIV-positive and HIV-negative participants ( P=0.3 ) , although HIV-positive patients had significantly higher Framingham risk score ( P=0.009 ) and systemic inflammation . Expression of two monocyte markers , CD11b and CX3CR1 , independently predicted carotid artery thickness in HIV-positive individuals after controlling for Framingham risk score ( P=0.025 and 0.015 , respectively ) . These markers were not predictive of carotid artery thickening in controls . Our study indicates that monocyte surface markers may serve as novel predictors of CVD in HIV-positive individuals and is consistent with an important role for monocyte activation in the progression of HIV-related cardiovascular pathology BACKGROUND The relationships between soluble CD14 ( sCD14 ) , endotoxin ( lipopolysaccharide [ LPS ] ) , and progression of atherosclerosis have not been defined in human immunodeficiency virus ( HIV ) infection . METHODS We retrospectively assessed serum sCD14 and LPS levels of 91 subjects in a prospect i ve 3-year study of carotid artery intima-media thickness ( CIMT ) ( AIDS Clinical Trials Group [ ACTG ] 5078 ) , where subjects were enrolled as risk factor-controlled triads of HIV-uninfected ( n = 36 ) and HIV-infected individuals with ( n = 29 ) or without ( n = 26 ) protease inhibitor (PI)-based therapy for ≥2 years . The primary end point was the yearly rate of change of CIMT ( ΔCIMT ) . RESULTS In multivariate analysis of the HIV-infected subjects , each 1 µg/mL above the mean of baseline serum sCD14 corresponded to an additional 1.52 µm/y ( 95 % confidence interval , .07 - 2.98 ; P = .04 ) in the ΔCIMT . Every 100 pg/mL above the mean of baseline serum LPS corresponded to an additional 0.49 µm/y ( 95 % confidence interval , .18-.81 ; P = .003 ) in the ΔCIMT . However , in univariate \n Output:\n " }, { "from": "agent", "value": "CRP , IL-6 and soluble vascular cell adhesion molecule ( sVCAM-1 ) were the most studied markers in relation to CIMT .\nNone of the inflammatory markers showed an association with CIMT .\nInterpretation This review showed a relation between some inflammatory markers and CVD , however , no consistent relation is observed for CIMT ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Long-acting injectable formulations of antipsychotics are treatment alternatives to oral agents . AIMS To assess the efficacy of aripiprazole once-monthly compared with oral aripiprazole for maintenance treatment of schizophrenia . METHOD A 38-week , double-blind , active-controlled , non-inferiority study ; r and omisation ( 2:2:1 ) to aripiprazole once-monthly 400 mg , oral aripiprazole ( 10 - 30 mg/day ) or aripiprazole once-monthly 50 mg ( a dose below the therapeutic threshold for assay sensitivity ) . ( TRIAL REGISTRATION clinical trials.gov , NCT00706654 . ) RESULTS A total of 1118 patients were screened , and 662 responders to oral aripiprazole were r and omised . Kaplan-Meier estimated impending relapse rates at week 26 were 7.12 % for aripiprazole once-monthly 400 mg and 7.76 % for oral aripiprazole . This difference ( -0.64 % , 95 % CI -5.26 to 3.99 ) excluded the predefined non-inferiority margin of 11.5 % . Treatments were superior to aripiprazole once-monthly 50 mg ( 21.80 % , P < or = 0.001 ) . CONCLUSIONS Aripiprazole once-monthly 400 mg was non-inferior to oral aripiprazole , and the reduction in Kaplan-Meier estimated impending relapse rate at week 26 was statistically significant v. aripiprazole once-monthly 50 mg OBJECTIVE Despite the frequent use of the Positive and Negative Syndrome Scale ( PANSS ) for rating the symptoms of schizophrenia , the clinical meaning of its total score and of the cut-offs that are used to define treatment response ( e.g. at least 20 % or 50 % reduction of the baseline score ) are as yet unclear . We therefore compared the PANSS with simultaneous ratings of Clinical Global Impressions ( CGI ) . METHOD PANSS and CGI ratings at baseline ( n = 4091 ) , and after one , two , four and six weeks of treatment taken from a pooled data base of seven pivotal , multi-center antipsychotic drug trials on olanzapine or amisulpride in patients with exacerbations of schizophrenia were compared using equipercentile linking . RESULTS Being considered \" mildly ill \" according to the CGI approximately corresponded to a PANSS total score of 58 , \" moderately ill \" to a PANSS of 75 , \" markedly ill \" to a PANSS of 95 and severely ill to a PANSS of 116 . To be \" minimally improved \" according to the CGI score was associated with a mean percentage PANSS reduction of 19 % , 23 % , 26 % and 28 % at weeks 1 , 2 , 4 and 6 , respectively . The corresponding figures for a CGI rating \" much improved \" were 40 % , 45 % , 51 % and 53 % . CONCLUSIONS The results provide a better framework for underst and ing the clinical meaning of the PANSS total score in drug trials of schizophrenia patients with acute exacerbations . Such studies may ideally use at least a 50 % reduction from baseline cut-off to define response rather than lower thresholds . In treatment resistant population s , however , even a small improvement can be important , so that a 25 % cut-off might be appropriate PURPOSE The aim of this longitudinal study was to determine whether the depot formulation of an antipsychotic reduces violence in out patients with schizophrenia as compared to oral administration of the same antipsychotic . METHODS Forty-six previously violent patients with schizophrenia were r and omised to receive treatment with oral or depot zuclopenthixol for 1 year . Clinicians interviewed patients at baseline and every month thereafter to assess treatment adherence . An interviewer blinded to treatment assignments interviewed an informant about any violent behaviour during the previous month . RESULTS Violence during the follow-up year was inversely proportional to treatment adherence , better compliance , and greater reduction of positive symptoms . Lower frequency of violent acts was observed in the depot group . The level of insight at baseline was not significantly associated with violence recidivism . Regardless of route of administration , treatment non-adherence was the best predictor of violence . CONCLUSIONS Some patients with schizophrenia and prior violent behaviour may benefit from the depot formulation of antipsychotic medication OBJECTIVE Potency equivalents for anti-psychotic drugs are required to guide clinical dosing and for design ing and interpreting research studies . Available dosing guidelines are limited by the methods and data from which they were generated . METHOD With a two-step Delphi method , the authors surveyed a diverse group of international clinical and research experts , seeking consensus regarding antipsychotic dosing . The authors determined median clinical dosing equivalents and recommended starting , target range , and maximum doses for 61 drugs , adjusted for selected clinical circumstances . RESULTS Participants ( N=43 ) from 18 countries provided dosing recommendations regarding treatment of psychotic disorders for 37 oral agents and 14 short-acting and 10 long-acting parenteral agents . With olanzapine 20 mg/day as reference , estimated clinical equivalency ratios of oral agents ranged from 0.025 for sulpiride to 10.0 for trifluperidol . Seventeen patient and treatment characteristics , including age , hepatic and renal function , illness stage and severity , sex , and diagnosis , were associated with dosing modifications . CONCLUSIONS In the absence of adequate prospect i ve , r and omized drug-drug comparisons , the present findings provide broad , international , expert consensus-based recommendations for most clinical ly employed antipsychotic drugs . They can support clinical practice , trial design , and interpretation of comparative antipsychotic trials A double-blind cross-over trial comparing oral fluphenazine and fluphenazine enanthate in 43 chronic in-patient male schizophrenics showed that both were efficacious . On the total score assessment fluphenazine was statistically superior to fluphenazine enanthate , but the overall clinical impression showed a slight superiority for fluphenazine enanthate . Fewer patients needed anti-parkinson medication during the trial period . Patients were as adequately controlled as they had been before the trial on a variety of phenothiazines . The results are discussed , and important factors , such as the certainty that the patients are receiving their medication with the long-acting injection and the saving of time for overworked nursing staff , are stressed IMPORTANCE Long-acting , injectable , second-generation antipsychotic medication has tremendous potential to bring clinical stability to persons with schizophrenia . However , long-acting medications are rarely used following a first episode of schizophrenia . OBJECTIVE To compare the clinical efficacy of the long-acting injectable formulation of risperidone with the oral formulation in the early course of schizophrenia . DESIGN , SETTING , AND PARTICIPANTS A r and omized clinical trial performed at a university-based research clinic , between 2005 and 2012 . Eighty-six patients with recent onset of schizophrenia were r and omized to receive long-acting injectable risperidone or oral risperidone . Half of each group was simultaneously r and omized to receive cognitive remediation to improve cognitive functioning or healthy-behaviors training to improve lifestyle habits and well-being . An intent-to-treat analysis was performed between October 4 , 2012 , and November 12 , 2014 . INTERVENTIONS A 12-month trial comparing the long-acting injectable vs oral risperidone and cognitive remediation vs healthy-behaviors training . MAIN OUTCOMES AND MEASURES Psychotic relapse and control of breakthrough psychotic symptoms . RESULTS Of the 86 patients r and omized , 3 refused treatment in the long-acting injectable risperidone group . The psychotic exacerbation and /or relapse rate was lower for the long-acting risperidone group compared with the oral group ( 5 % vs 33 % ; χ21 = 11.1 ; P < .001 ; relative risk reduction , 84.7 % ) . Long-acting injectable risperidone better controlled mean levels of hallucinations and delusions throughout follow-up ( β = -0.30 ; t68 = -2.6 , P = .01 ) . The cognitive remediation and healthy-behaviors training groups did not differ significantly regarding psychotic relapse , psychotic symptom control , or hospitalization rates , and there were no significant interactions between the 2 medications and the 2 psychosocial treatments . Discontinuations owing to inadequate clinical response were more common in the oral group than in the long-acting risperidone group ( χ21 = 6.1 ; P = .01 ) . Adherence to oral risperidone did not appear to differ before r and omization but was better for the long-acting risperidone group compared with the oral group ( t80 = 5.3 ; P < .001 ) . Medication adherence was associated with prevention of exacerbation and /or relapse ( χ21 = 11.1 ; P = .003 ) and control of breakthrough psychotic symptoms ( β = 0.2 ; t79 = 2.1 ; P = .04 ) . CONCLUSIONS AND RELEVANCE The use of long-acting injectable risperidone after a first episode of schizophrenia has notable advantages for clinical outcomes . The key clinical advantages are apparently owing to the more consistent administration of the long-acting injectable . Such formulations should be offered earlier in the course of illness . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00333177 Long-acting injectable antipsychotics ( LAIs ) should offer better efficacy and tolerability , compared to oral antipsychotics due to improved adherence and more stable pharmacokinetics . However , data on LAIs has been mixed , with some studies finding that they are more effective and tolerable than oral antipsychotics , and others finding the contrary . One possibility for the disparate results may be that some studies administered different antipsychotics in the oral and injectable form . The present systematic review examined the efficacy and tolerability of LAIs versus their oral equivalents in r and omized and naturalistic studies . In addition , it examined the impact of LAIs on special population s such as patients with first-episode psychosis , substance use disorders , and a history of violence or on involuntary outpatient commitment . R and omized studies suggest that not all LAIs are the same ; for example , long-acting risperidone may be associated with equal or less side effects than oral risperidone , whereas fluphenazine decanoate and enanthate may be associated with equal or more side effects than oral fluphenazine . They also suggest that LAIs reduce risk of relapse versus oral antipsychotics in schizophrenia out patients when combined with quality psychosocial interventions . For their part , naturalistic studies point to a larger magnitude of benefit for LAIs , relative to their oral equivalents particularly among first-episode patients OBJECTIVES The aim of the study was to assess whether the well-tolerated serotonin re-uptake inhibitor paroxetine hydrochloride could prevent vasovagal syncope in young patients resistant to or intolerant of previous traditional therapies . BACKGROUND Serotonergic mechanisms may play a major role in the pathophysiology of neurocardiogenic syncope , and serotonin re-uptake inhibitors have been recently reported to be effective in preventing episodes . METHODS Forty-one consecutive young patients ( 13 male and 28 female ) , aged less than thirty years with recurrent syncope and positive head-up tilt test , and in whom st and ard therapies with beta-blocking , vagolytic , negative inotropic or mineral corticoid agents were ineffectual , poorly tolerated or contraindicated , r and omly received either paroxetine at 20 mg once a day or a placebo . A head-up tilt test was then re-performed after one month of treatment , and the clinical effect was noted over a mean follow-up of 27.1 + /- 6.6 months . RESULTS The response rates ( negative tilt test ) after one month of treatment were 57.1 versus 33.3 % ( p < 0.001 ) in the paroxetine and placebo groups , respectively . During follow-up , spontaneous syncope was observed in 4 patients ( 19 % ) in the paroxetine group and in 12 patients ( 60 % ) in the placebo group ( p < 0.001 ) . Only one patient ( 4.8 % ) asked to be discontinued from the drug for severe recurrent headache . CONCLUSIONS Paroxetine significantly improved symptoms of young patients with recurrent vasovagal syncope unresponsive to or intolerant of traditional medications and was well tolerated by patients OBJECTIVE Previous studies showed clinical benefit of risperidone long-acting injection in the treatment of schizophrenia . However , the equivalent switching dose from oral risperidone to risperidone long-acting injection was still in debate . This study , conducted among hospitalized patients , included a long-enough study period and optimal control of drug compliance to test the equivalent switching dose . METHOD Fifty symptomatic , stable hospitalized patients with DSM-IV schizophrenia were r and omly assigned to receive either daily oral risperidone or risper \n Output:\n " }, { "from": "agent", "value": "Similarly , no differences emerged in terms of dropouts for adverse events , extrapyramidal symptoms , prolactin increase ( except for a small advantage for LAI risperidone ) , weight gain , non-response rate , relapse rate , and dropouts for inefficacy ( except for a small advantage for oral olanzapine ) .\nIn conclusion , there is no robust evidence to support doctors in choosing LAI instead of oral formulations in order to obtain better tolerability and efficacy" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The effect on serum high density lipoprotein subfractions of a low fat diet with a high ratio of polyunsaturated-to-saturated fatty acids was studied in 38 middle-aged volunteers ( 19 men and 19 women ) in North Karelia , Finl and . The mean serum HDL2 cholesterol decreased from 32 + /- 2 mg/dl ( mean + /- SE ) to 28 + /- 2 mg/dl ( p less than 0.001 ) during the experimental diet and returned to 33 + /- 2 mg/dl ( p less than 0.001 ) after a return to the original diet . No changes were observed in the concentration of HDL3 cholesterol . A highly significant decrease was observed in serum apoprotein A-I concentration , but not in apoprotein A-II concentration during the experimental diet . It is concluded that a low-fat , high-P/S ratio diet lowers LDL and HDL2 cholesterol in healthy volunteers , but does not influence the level of HDL3 subfraction The Minnesota Coronary Survey was a 4.5-year , open enrollment , single end-time , double-blind , r and omized clinical trial that was conducted In six Minnesota state mental hospitals and one nursing home . It Involved 4393 Institutionalized men and 4664 Institutionalized women . The trial compared the effects of a 39 % fat control diet ( 18 % saturated fat , 5 % polyunsaturated fat , 16 % monounsaturated fat , 446 mg dietary cholesterol per day ) with a 38 % fat treatment diet ( 9 % saturated fat , 15 % polyunsaturated fat , 14 % monounsaturated fat , 166 mg dietary cholesterol per day ) on serum cholesterol levels and the Incidence of myocardlal Infa rct ions , sudden deaths , and all-cause mortality . The mean duration of time on the diets was 384 days , with 1568 subjects consuming the diet for over 2 years . The mean serum cholesterol level In the pre-admission period was 207 mg/dl , falling to 175 mg/dl in the treatment group and 203 mg/dl In the control group . For the entire study population , no differences between the treatment and control groups were observed for cardiovascular events , cardiovascular deaths , or total mortality . A favorable trend for all these end-points occurred In some younger age groups It has been suggested that alpha-tocopherol , a safe and effective antioxidant , be used in clinical trials to evaluate the ability of antioxidant therapy to inhibit atherosclerosis . Recent reports , however , have raised the possibility that there may be greater enrichment of plasma low density lipoprotein ( LDL ) in alpha-tocopherol result ing from the use of the naturally occurring RRR-alpha-tocopherol isomer compared with the other isomers present in the synthetic racemic form of alpha-tocopherol . Therefore , we fed equal dosages ( 1,600 mg/day ) of the two forms of vitamin E to 16 men and women for 8 weeks and compared the effects of this supplementation on the susceptibility of isolated lipoproteins to oxidation . Neither form of vitamin E had appreciable effects on lipid or lipoprotein levels . alpha-Tocopherol levels in LDL increased at a similar rate in both groups and were nearly twofold higher than baseline levels by the end of the study . The susceptibility of LDL to oxidation was measured by formation of conjugated dienes , lipid peroxides , and thiobarbituric acid-reactive substances , as well as by macrophage degradation of LDL exposed to oxidizing conditions in vitro . The susceptibility of LDL to oxidation was decreased in both vitamin E groups compared with the baseline value , and this reduction occurred to a similar extent in both vitamin E-supplemented groups . alpha-Tocopherol levels in LDL also strongly correlated with all measures of LDL oxidation . This study demonstrates that , at this dosage , supplementation with either the natural or synthetic form of alpha-tocopherol provided equal antioxidant protection to LDL The effects of high oleic acid rapeseed oil compared with polyunsaturated fats on serum lipoprotein levels are largely unknown . Therefore , we fed 30 women and 29 men a baseline diet rich in saturated fat , which was followed by a diet rich in high oleic and low erucic acid rapeseed oil ( total energy content of fat , 38 % ; saturates , 12.4 % ; monounsaturates , 16 % ; n-6 polyunsaturates , 6 % ; and n-3 polyunsaturates , 2 % ) and one rich in sunflower oil ( total energy content of fat , 38 % ; saturates , 12.7 % ; monounsaturates , 10 % ; n-6 polyunsaturates , 13 % ; and n-3 polyunsaturates , 0 % ) . The oils were incorporated into mixed natural diets that were dispensed in a r and om order for 3.5 weeks each in a blinded crossover design . The diet composition was confirmed by analysis of duplicate diets . Both test diets reduced serum total cholesterol ( TC ) and low density lipoprotein ( LDL ) cholesterol levels from baseline , the monounsaturated rapeseed oil diet more than the polyunsaturated sunflower oil diet ( TC : -15 % versus -12 % , p less than 0.01 ; LDL cholesterol : -23 % versus -17 % , p less than 0.01 ) . Very low density lipoprotein ( VLDL ) cholesterol and total , VLDL , and LDL triglyceride levels were lower during the sunflower oil diet compared with the rapeseed oil diet . Total high density lipoprotein ( HDL ) cholesterol levels remained unchanged by both diets . The consumption of rapeseed oil result ed in a more favorable HDL2 to LDL cholesterol ratio ( 0.43 + /- 0.19 versus 0.39 + /- 0.18 , p less than 0.01 ) and an apolipoprotein A-I to B ratio ( 3.0 + /- 1.4 versus 2.4 + /- 1.6 , p less than 0.001 ) than did the sunflower oil . ( ABSTRACT TRUNCATED AT 250 WORDS This report describes the effects of feeding linoleate- or oleate-enriched diets to subjects who were concurrently taking 1200 mg/d of alpha-tocopherol on the susceptibility of low-density lipoprotein ( LDL ) and buoyant and dense LDL subfractions to oxidation . LDL isolated from subjects who consumed linoleate-enriched diets was more susceptible to copper-mediated oxidation , as measured by formation of conjugated dienes and lipid peroxides and loss of unsaturated fatty acids , compared with LDL isolated from subjects who consumed their usual or oleate-enriched diets . In all subjects , buoyant LDL had a higher content of alpha-tocopherol per particle and a lower 18:2 to 18:1 ratio and was considerably more resistant to oxidation than dense LDL . Although dense LDL from all groups had comparable alpha-tocopherol levels , dense LDL from the linoleate group was most susceptible to oxidation , followed by that from the st and ard diet , whereas dense LDL isolated from the oleate diet group was most resistant . In summary , high dosages of alpha-tocopherol did not prevent enhanced susceptibility to oxidation of LDL isolated from subjects fed linoleate-enriched diets . Furthermore , dense LDL was more susceptible to oxidation than was buoyant LDL , and this effect was greatly exaggerated in the dense LDL isolated from subjects fed linoleate-enriched diets . Conversely , dense LDL isolated from subjects fed oleate-enriched diets was the most protected . If oxidation of LDL is important in the pathogenesis of atherosclerosis , then these data suggest that in people with increased amounts of small , dense LDL , dietary enrichment in oleic acid may decrease the susceptibility of their LDL to oxidation Effects of small amounts of sitosterol , sitostanol and sitostanol esters ( < 1 g/day of free sterols ) dissolved in rapeseed oil ( RSO ) were studied on serum lipids and cholesterol metabolism in patients with primary hypercholesterolemia and different apolipoprotein E phenotypes on an RSO diet . One of the four groups was an RSO-fed control . Serum total and LDL cholesterol reductions were small in different plant sterol-fed groups , tended to be highest in the sitostanol ester group ( -7 % ) , but were significantly reduced by about 5 % in the combined plant sterol groups . The reductions were -8 % in the subjects with epsilon 4 allele and insignificant in those with apo E3/3 phenotype . Cholesterol precursor sterols in serum , markers of cholesterol synthesis , were increased only in the subjects with epsilon 4 allele . Cholesterol absorption was reduced by 7 % , being 31 % in the subjects with epsilon 4 allele , and fecal elimination of cholesterol was increased , a finding also indicating increased cholesterol synthesis . The changes in cholesterol absorption were related to those in fecal plant sterols ( change in dietary intake ) and serum total and LDL cholesterol ( P = 0.04 , 0.01 and 0.05 , respectively ) . Thus , small amounts of dietary plant sterols ( < 1 g/day ) , especially sitostanol esters dissolved in dietary fats , decrease serum total and LDL cholesterol by a proportional decrease in cholesterol absorption which , in turn , is associated with a compensatory increase in cholesterol synthesis . The effects are most consistent in subjects with epsilon 4 allele , but for effective hypocholesterolemic treatment dietary amount of sitostanol ester should exceed 1 g/day Background Do the benefits of intensive lipid-lowering therapy seen in symptomatic patients extend to high-risk subjects who have never had symptoms ? Methods and ResulsOf 120 men completing the FATS trial , 91 were symptomatic and 29 asymptomatic . All had apolipoprotein B 2125 mg/dL , a positive family history , and coronary atherosclerosis . All were counseled in diet and r and omized to intensive therapy : colestipol 10 g TID plus either niacin 1 g QID or lovastatin 20 mg BID or to conventional therapy : placebos , or colestipol if low-density lipoprotein cholesterol was elevated . End points included quantitative arteriographic disease change and clinical events over a 2.5-year interval . At baseline , symptomatic and asymptomatic patients had comparable risk profiles , but proximal stenosis severity averaged 36 % for symptomatic and 23 % for asymptomatic patients ( P<.001 ) . Among the 91 symptomatic patients , those in the intensive group experienced definite ( .101%S ) proximal lesion progression less frequently than conventional ( 24 % of intensive versus 48 % of conventional ) and definite regression more frequently ( 36 % of intensive versus 15 % of conventional ) ( P=.009 ) . Similarly , among the 29 asymptomatic patients , 19 % of intensive versus 38 % of conventional had progression and 31 % of intensive versus 0%1 of conventional , regression ( P=.04 ) . Ischemia on baseline exercise tolerance testing was associated with significantly greater proximal disease progression among the asymptomatic patients . Clinical cardiovascular events ( death , infa rct ion , or revascularization ) occurred in 10 of 38 symptomatic patients originally assigned to conventional therapy , compared with 5 of 76 symptomatic patients assigned to intensive ( P<.01 ) ; no asymptomatic patient had an event . ConcluionsAsymptomatic subjects with this high-risk profile have less coronary disease at baseline than comparable symptomatic patients , and they have an excellent short-term clinical prognosis . However , asymptomatic subjects are indistinguishable from symptomatic patients in terms of their arterial disease progression with conventional therapy and their regression with intensive . These findings may justify an active treatment strategy in such subjects , particularly those with provokable ischemia The primary aim of this study was to estimate the relation between cholesterol reduction and total mortality and coronary heart disease ( CHD ) incidence . Secondarily , the clinical issues of whether the efficacy of cholesterol lowering is dependent on the treatment modality , presence of CHD at baseline , or the simultaneous introduction of other interventions was explored . All r and omized clinical intervention trials of cholesterol reduction were used in an overview analysis of total mortality rate and CHD incidence ; analysis was performed with weighted linear regression . The trials include those that used primary and secondary intervention , diet and drugs , and single or multifactor design . Nineteen trials were analyzed for total mortality , and of the 19 , 16 were analyzed for CHD incidence rate . Net difference in cholesterol change between study groups was used as the independent variable , and the three previously mentioned dichotomous design characteristics were used as additional independent variables . For every 1 % reduction in cholesterol , an estimated 2.5 % reduction in CHD incidence is indicated ( 95 % CL : 1.1 , 3.9 ) . With regard to CHD drug trials tended toward better efficiency in cholesterol lowering than did dietary trials . \n Output:\n " }, { "from": "agent", "value": "No significant difference was noted for the majority of secondary outcomes for any of the planned comparisons ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Residential treatment for substance use disorders ( SUD ) provides opportunity for smoking intervention . A r and omized controlled trial compared : ( 1 ) motivational interviewing ( MI ) to brief advice ( BA ) , ( 2 ) in one session or with two booster sessions , for 165 alcoholics in SUD treatment . All received nicotine replacement ( NRT ) . MI and BA produced equivalent confirmed abstinence , averaging 10 % at 1 month , and 2 % at 3 , 6 and 12 months . However , patients with more drug use pretreatment ( > 22 days in 6 months ) given BA had more abstinence at 12 months ( 7 % ) than patients in MI or with less drug use ( all 0 % ) . Boosters produced 16 - 31 % fewer cigarettes per day after BA than MI . Substance use was unaffected by treatment condition or smoking cessation . Motivation to quit was higher after BA than MI . Thus , BA plus NRT may be a cost-effective way to reduce smoking for alcoholics with comorbid substance use who are not seeking smoking cessation BACKGROUND Motivational interviewing ( MI ) is widely used for adolescent smoking cessation but empirical support for this approach is mixed . METHODS Adolescent cigarette smokers 14 - 18 years old ( N=162 ) were recruited from medical , school , and community setting s and r and omly assigned to enhanced MI or brief advice ( BA ) for smoking cessation . MI comprised an in-person individual session , a telephone booster session one week later , and a brief telephone-based parent intervention . BA consisted of st and ardized brief advice to quit smoking . Assessment s occurred at baseline , post-treatment and at 1- , 3- , and 6-month follow ups . RESULTS Biochemically-confirmed 7-day point prevalence abstinence rates were low ( e.g. , 4.5 % for MI ; 1.4 % for BA at 1 month ) and did not differ significantly by group at any follow up . Only those in MI reported significant decreases in cigarettes smoked per day ( CPD ) from baseline to 1 month . At 3 and 6 months , smokers in both groups reported significantly reduced CPD with no differences between groups . MI reduced perceived norms regarding peer and adult smoking rates , while BA had no effect on normative perceptions . No group differences emerged for self-reported motivation or self-efficacy to quit smoking . CONCLUSIONS Findings support the efficacy of MI for addressing normative misperceptions regarding peer and adult smoking and for modestly reducing CPD in the short-term ; however , these effects did not translate to greater smoking abstinence . MI may have more promise as a prelude to more intensive smoking intervention with adolescents than as a st and -alone intervention INTRODUCTION The efficacy of contingency-management ( CM ) and motivational enhancement therapy ( MET ) for college student smoking cessation was examined . METHODS Nontreatment-seeking daily smokers ( N = 110 ) were r and omly assigned to 3 weeks of CM versus noncontingent reinforcement ( NR ) and to three individual sessions of MET versus a relaxation control in a 2 x 2 experimental design . Expired carbon monoxide ( CO ) sample s were collected twice daily for 3 weeks . Participants earned 5 US dollars for providing each sample ; additionally , those r and omized to CM earned escalating monetary rewards based on CO reductions ( Week 1 ) and smoking abstinence ( Weeks 2 - 3 ) . RESULTS Compared with NR , CM result ed in significantly lower CO levels and greater total and consecutive abstinence during the intervention . Those in the CM and MET groups reported greater interest in quitting smoking posttreatment , but rates of confirmed abstinence at follow-up were very low ( 4 % at 6-month follow-up ) and did not differ by group . DISCUSSION Findings support the short-term efficacy of CM for reducing smoking among college students . Future research should explore enhancements to CM in this population , including a longer intervention period and the recruitment of smokers who are motivated to quit ABSTRACT Background : Tobacco use is higher among homeless individuals than the general population . Homeless individuals are also more likely to have symptoms of depression . Depression symptoms may add to the burden of homelessness by increasing psychological distress and serve as a barrier to quitting smoking . Objectives : The primary goal of this study is to assess the impact of depression symptoms on psychological distress in homeless smokers . The effect of depression symptoms on abstinence and the effect of Motivational Interviewing ( MI ) on cessation among smokers is also explored . Methods : Homeless smokers ( N = 430 ) enrolled in a smoking cessation study were r and omized to Motivational Interviewing ( MI ) or st and ard care ( SC ) . Participants received nicotine replacement therapy and were followed for 26 weeks . Participants were categorized into a depression symptoms ( DS ) group or control group using the Patient Health Question naire-9 . Between group differences of perceived stress , hopelessness , confidence , craving and abstinence were assessed at weeks 8 and 26 . The interaction between depression symptoms ( levels : DS and control ) and the intervention ( levels : MI and SC ) was also assessed . Results : Homeless smokers in the DS group reported higher levels of hopelessness , perceived stress , and craving . There was no effect of DS status on abstinence at week 8 or week 26 . There was no significant interaction between depression symptoms ( DS vs. Control ) and the intervention ( MI vs. SC ) . Conclusion : Despite reporting greater psychological distress , homeless smokers with depression symptoms in this sample had abstinence levels similar to the control group . Future research should explore protective factors among depressed smokers OBJECTIVE To evaluate the effectiveness of a lifestyle intervention for male workers in the construction industry at risk of cardiovascular disease ( CVD ) . METHODS In a r and omized controlled trial performed in the Netherl and s between 2007 and 2009 , usual care was compared to 6 months of individual counseling using motivational interviewing techniques , delivered face to face and by telephone . Participants aim ed at improving energy balance-related behavior or smoking cessation . Linear regression analyses were performed to determine the effects . RESULTS Body weight had significantly decreased at 6 ( β=-1.9 , 95 % CI -2.6 ; -1.2 ) and 12 months ( β=-1.8 , 95%CI -2.8 ; -1.1 ) . The intervention effects were also significant for diastolic blood pressure at 6 months ( β=-1.7 , 95 % CI -3.3 ; -0.1 ) . Among participants who had aim ed at energy balance , the intervention had a significant favorable effect on body weight at 6 ( β=-2.1 , 95 % CI -2.9 ; -1.3 ) and 12 months ( β=-2.2 , 95 % CI -3.1 ; -1.3 ) and at HDL cholesterol ( β=0.05 , 95 % CI 0.01 ; 0.10 ) and HbA1c ( β=-0.06 , 95%CI -0.12 ; -0.001 ) at 12 months , although there was no intervention effect on these variables over time . CONCLUSION Individual-based counseling result ed in significant beneficial long-term effects on body weight . This is an important finding for occupational health , considering the rising prevalence of obesity and CVD INTRODUCTION Smokers with serious mental illness ( SMI ) have a high smoking prevalence and a low quit rate . Motivational interviewing ( MI ) is an empirically supported approach for addressing substance use disorders and may motivate smokers with SMI to quit . METHODS We r and omized smokers ( N = 98 ) with SMI to receive a single 45-minute session of ( 1 ) MI with personalized feedback or ( 2 ) interactive education . We hypothesized that participants receiving the MI intervention would be more likely to follow-up on a referral for tobacco dependence treatment , to make a quit attempt , and to quit smoking than those receiving the interactive educational intervention . RESULTS Smokers receiving an MI intervention were significantly more likely to make a quit attempt by the 1-month follow-up ( 34.7 % vs. 14.3 % ; OR = 4.39 [ 95 % CI = 1.44 to 13.34 ] , P = .009 ) ; however , these quit attempts did not translate into abstinence . In addition , 32.7 % of those receiving MI followed-up on a referral for tobacco dependence treatment ( vs. 20.4 % receiving interactive education ; OR = 2.02 [ 95 % CI = 0.76 to 3.55 ] , P = .157 ) . MI Treatment Integrity Code ratings indicated that the interventions were easily distinguishable from each other and that MI was delivered with proficiency . Despite the intervention 's brevity , participants reported high levels of therapeutic alliance with their therapist . CONCLUSIONS A brief adaptation of MI with personalized feedback appears to be a promising approach for increasing quit attempts in smokers with SMI , but future research is required to determine how to best help smokers with SMI to attain sustained abstinence Background Intensive lifestyle interventions in well-controlled setting s are effective in lowering the risk of chronic diseases such as type 2 diabetes ( T2DM ) and cardiovascular diseases ( CVD ) , but there are still no effective lifestyle interventions for everyday practice . In the Hoorn Prevention Study we aim ed to assess the effectiveness of a primary care based lifestyle intervention to reduce the estimated risk of developing T2DM and for CVD mortality , and to motivate changes in lifestyle behaviors . Methods The Hoorn Prevention Study is a parallel group r and omized controlled trial , implemented in the region of West-Friesl and , the Netherl and s. 622 adults with ≥10 % estimated risk of T2DM and /or CVD mortality were r and omly assigned and monitored over a period of 12 months . The intervention group ( n=314 ) received a theory-based lifestyle intervention based on an innovative combination of motivational interviewing and problem solving treatment , provided by trained practice nurses in 12 general practice s. The control group ( n=308 ) received existing health brochures . Primary outcomes was the estimated diabetes risk according to the formula of the Atherosclerosis Risk In Communities ( ARIC ) Study , and the estimated risk for CVD mortality according to the Systematic COronary Risk Evaluation ( SCORE ) formula . Secondary outcomes included lifestyle behavior ( diet , physical activity and smoking ) . The research assistants , the principal investigator and the general practitioners were blinded to group assignment . Linear and logistic regression analysis was applied to examine the between-group differences in each outcome measure , adjusted for baseline values . Results 536 ( 86.2 % ) of the 622 participants ( age 43.5 years ) completed the 6-month follow-up , and 502 ( 81.2 % ) completed the 12-month follow-up . The mean baseline T2DM risk was 18.9 % ( SD 8.2 ) and the mean CVD mortality risk was 3.8 % ( SD 3.0 ) . The intervention group participated in a median of 2 sessions . Intention-to-treat analyses showed no significant differences in outcomes between the two groups at 6 or 12-months follow-up . Conclusions The lifestyle intervention was not more effective than health brochures in reducing risk scores for T2DM and CVD or improving lifestyle behavior in an at-risk population .Trial registration Current Controlled Trials : IS RCT INTRODUCTION Concerns about retention are a major barrier to conducting studies enrolling homeless individuals . Since smoking is a major problem in homeless communities and research on effective methods of promoting smoking cessation is needed , we describe strategies used to increase retention and participant characteristics associated with retention in smoking cessation study enrolling homeless adults . METHODS The parent study was a 2-group r and omized controlled trial with 26-week follow-up enrolling 430 homeless smokers from emergency shelters and transitional housing units in Minneapolis/Saint Paul , MN , USA . Multiple strategies were used to increase retention , including conducting visits at convenient locations for participants , collecting several forms of contact information from participants , using a schedule that was flexible and included frequent low-intensity visits , and providing incentives . Participant demographics as well as characteristics related to tobacco and drug use and health status were analyzed for associations with retention using univariate and multivariate analysis . RESULTS Overall retention was 75 % at 26 weeks . Factors associated with increased retention included greater age ; having healthcare coverage ; history of multiple homeless episodes , lower stress level ; and higher PHQ-9 ( Patient Health Question naire-9 ) score . A history of excessive drinking and drug use were associated with decreased retention . CONCLUSIONS It is possible to successfully retain homeless individuals in a smoking cessation study if the study is design ed with participants ' needs in mind BACKGROUND Smoking reduction has been introduced as an alternative to smokers unable or unwilling to quit but has never been implemented in a population -based intervention . METHODS Two thous and four hundred eight daily smokers in all motivational stages were included in a r and omised population -based intervention study , in Copenhagen , Denmark . Smokers , unwilling or unable to quit , were encouraged to reduce their tobacco consumption . Furthermore , smokers in the high-intensity intervention \n Output:\n " }, { "from": "agent", "value": "Single-session treatments might increase the likelihood of quitting over multiple sessions , but both regimens produced positive outcomes .\nEvidence is unclear at present on the optimal number of follow-up calls .\nMotivational interviewing may assist people to quit smoking ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: PURPOSE The purpose of this article was to investigate the role of control beliefs in mediating the relationship between driving cessation and change in depressive symptoms in a population -based sample of older adults . DESIGN AND METHODS We report results from a prospect i ve , community-based cohort study that included two waves of data collected in 1992 and 1994 . Participants consisted of 700 men and women aged 70 and older , including 647 drivers and 53 participants who ceased driving between baseline ( 1992 ) and follow-up ( 1994 ) . Participants took part in interviews that included assessment s of driving status , sociodemographic characteristics , self-rated health , sensory function , depressive symptoms ( through the Center for Epidemiologic Studies -Depression scale ) , and expectancy of control . Using multilevel general linear models , we examined the extent to which driving status , expectancy of control , and relevant covariates explained change in depressive-symptom scores between baseline and follow-up . RESULTS Driving cessation was associated with an increase in depressive symptoms from baseline to follow-up . The higher depressive-symptom scores of ceased drivers relative to those of individuals who remained drivers at both waves was partly explained by a corresponding decrease in the sense of control among ceased drivers , and increased control beliefs among drivers . IMPLICATION S Interventions aim ed at promoting the maintenance of personal agency and associated control beliefs could be protective against the negative psychological concomitants of driving cessation Driving has been regarded as an activity of daily living that is important in maintaining a person 's independence in the community , access to employment , and social activities . Many patients , however , using opioid medications on a regular basis ( Chronic Opioid Analgesic Therapy : COAT ) to ameliorate their intractable pain have been restricted from driving out of concern that skills would be impaired and driving safety compromised by these medications . Yet there are no driving studies which have explored the effects of using opioid analgesics for an extended period of time . This pilot study was design ed to determine the effects of medically prescribed , stable opioid use on the driving abilities of patients with persistent , nonmalignant pain . Sixteen patients with chronic nonmalignant pain on COAT , who met criteria for participation in the study , underwent a comprehensive off-road driving evaluation using measures which have been shown to be sensitive in predicting on-road driving performance . The evaluation consisted of a pre-driver evaluation ( PDE ) , a simulator evaluation ( SDE ) , and behavioral observation during simulator performance . Patients in the COAT group were compared to a historical control group of 327 cerebrally compromised patients ( CComp ) who had undergone the same evaluation and then passed an on-road , behind-the-wheel evaluation ( BTW Pass ; n = 162 ) or failed ( BTW Fail ; n = 165 ) . Results revealed that COAT patients generally outperformed the CComp patients as a group by equaling or exceeding PDE and SDE scores of the BTW Fail patients as well as the BTW Pass patients on all measures that differentiated the groups . Notably , COAT patients had a relatively poorer performance than CComp patients on specific neuropsychometric tests in the PDE ; however , the differences were not statistically significant and did not imply a systematic pattern of scores that reflected domain-specific deficits . Behaviorally , COAT patients were generally superior to CComp patients , also ; however , COAT patients had greater difficulty in following instructions and as well as a tendency toward impulsivity , like the BTW fail group . While there was general support for the notion that COAT did not significantly impair the perception , cognition , coordination , and behavior measured in off-road tests that have been regarded as requisite for on-road driving , method ological problems may limit the generalizability of results and recommendations are made for research beyond a pilot study & NA ; Pain intensity is frequently measured on an 11‐point pain intensity numerical rating scale ( PI‐NRS ) , where 0=no pain and 10=worst possible pain . However , it is difficult to interpret the clinical importance of changes from baseline on this scale ( such as a 1‐ or 2‐point change ) . To date , there are no data driven estimates for clinical ly important differences in pain intensity scales used for chronic pain studies . We have estimated a clinical ly important difference on this scale by relating it to global assessment s of change in multiple studies of chronic pain . Data on 2724 subjects from 10 recently completed placebo‐controlled clinical trials of pregabalin in diabetic neuropathy , postherpetic neuralgia , chronic low back pain , fibromyalgia , and osteoarthritis were used . The studies had similar design s and measurement instruments , including the PI‐NRS , collected in a daily diary , and the st and ard seven‐point patient global impression of change ( PGIC ) , collected at the endpoint . The changes in the PI‐NRS from baseline to the endpoint were compared to the PGIC for each subject . Categories of ‘ much improved ’ and ‘ very much improved ’ were used as determinants of a clinical ly important difference and the relationship to the PI‐NRS was explored using graphs , box plots , and sensitivity/specificity analyses . A consistent relationship between the change in PI‐NRS and the PGIC was demonstrated regardless of study , disease type , age , sex , study result , or treatment group . On average , a reduction of approximately two points or a reduction of approximately 30 % in the PI‐NRS represented a clinical ly important difference . The relationship between percent change and the PGIC was also consistent regardless of baseline pain , while higher baseline scores required larger raw changes to represent a clinical ly important difference . The application of these results to future studies may provide a st and ard definition of clinical ly important improvement in clinical trials of chronic pain therapies . Use of a st and ard outcome across chronic pain studies would greatly enhance the comparability , validity , and clinical applicability of these studies Abstract Objective To determine the efficacy of oral morphine in relieving the sensation of breathlessness in patients in whom the underlying aetiology is maximally treated . Design R and omised , double blind , placebo controlled crossover study . Setting Four outpatient clinics at a hospital in South Australia . Participants 48 participants who had not previously been treated with opioids ( mean age 76 , SD 5 ) with predominantly chronic obstructive pulmonary disease ( 42 , 88 % ) were r and omised to four days of 20 mg oral morphine with sustained release followed by four days of identically formulated placebo , or vice versa . Laxatives were provided as needed . Main outcome measures Dyspnoea in the morning and evening as shown on a 100 mm visual analogue scale , quality of sleep , wellbeing , performance on physical exertion , and side effects as measured at the end of the four day treatment period . Results 38 participants completed the study ; three withdrew because of definite and two because of possible side effects of morphine ( nausea , vomiting , and sedation ) . Participants reported significantly different dyspnoea scores when treated with morphine : an improvement of 6.6 mm ( 95 % confidence interval 1.6 mm to 11.6 mm ) in the morning and of 9.5 mm ( 3.0 mm to 16.1 mm ) in the evening ( P = 0.011 and P = 0.006 , respectively ) . During the period in which they were taking morphine participants also reported better sleep ( P = 0.039 ) . More participants reported distressing constipation while taking morphine ( 9 v 1 , P = 0.021 ) in spite of using laxatives . All other side effects were not significantly worse with morphine , although the study was not powered to address side effects . Conclusions Sustained release , oral morphine at low dosage provides significant symptomatic improvement in refractory dyspnoea in the community setting OBJECTIVES Increasing age , socioeconomic factors , and declining function and health have been linked to driving cessation , but little is known about the consequences of stopping driving . This study was design ed to test the hypothesis that driving cessation leads to a decline in out-of-home activity levels . METHODS In 1989 a survey of driving practice s was administered to surviving noninstitutionalized members of the New Haven Established Population s for Epidemiologic Studies of the Elderly ( EPESE ) cohort . Of 1,316 respondents , 502 were active drivers as of 1988 , 92 had stopped driving between 1982 and 1987 , and 722 never drove or stopped before 1982 . Information on sociodemographic and health-related variables came from in-home EPESE interviews in 1982 , 1985 , and 1988 , and from yearly phone interviews . Activity was measured at all three in-home interviews , and an activity measure was created based on self-reported participation in nine out-of-home activities . A repeated measures r and om-effects model was used to test the effect of driving cessation on activity while controlling for potential confounders . RESULTS Driving cessation was strongly associated with decreased out-of-home activity levels ( coefficient-1.081 , st and ard error 0.264 , p < .001 ) after adjustment for sociodemographic and health-related factors . DISCUSSION The potential consequences of driving limitations or cessation should be taken into account when advising older drivers and developing alternative transportation strategies to help maintain their mobility Context Obstructive sleep apnea ( OSA ) is associated with sleepiness and poor concentration , symptoms that could impair driving performance . Contribution This study evaluated simulated driving performance in 38 patients with untreated OSA and 20 control participants under 3 conditions : unrestricted sleep , sleep restriction , and consumption of alcohol . Compared with control participants , patients with untreated OSA had worse simulated driving performance . Patients with OSA also had greater decrements in driving performance after sleep restriction and after alcohol consumption . Implication Consider alerting patients about the potential negative influence of untreated OSA on driving performance and their heightened vulnerability after sleep deprivation and alcohol consumption . The Editors Obstructive sleep apnea ( OSA ) causes excessive daytime somnolence and reduced vigilance , concentration , and neurocognitive function ( 1 , 2 ) . Patients with OSA , particularly those with moderate to severe disease , have a 2- to 7-fold increased risk for motor vehicle accidents ( 310 ) . Community surveys have shown that approximately 7 % of the middle-aged population has at least mild OSA ( > 10 obstructive events per hour of sleep ) ( 1113 ) , and up to 80 % of these cases are undiagnosed ( 1416 ) . For patients whose condition is diagnosed , delays in instituting treatment are common ( 17 ) . Between 46 % and 83 % of patients do not adhere to treatment over the long term ( 18 ) . The many patients with undiagnosed or untreated OSA represent a serious public health concern with respect to road safety . Accidents related to OSA result in an estimated 1400 road fatalities and cost $ 15.9 billion annually in the United States alone ( 19 ) . Improving access to diagnosis and treatment may help reduce this public health burden . However , even with improved sleep medicine services , many unidentified or untreated patients with OSA will probably remain at increased risk for motor vehicle accidents . A better underst and ing of the factors contributing to motor vehicle accidents among patients with OSA is therefore needed to develop cost-effective prevention strategies . This study was design ed to compare the effects of 2 common lifestyle factors , low-dose alcohol and acute partial sleep deprivation , on driving simulator performance between untreated patients with OSA and healthy matched control participants . We postulated that because of previous chronic sleep disruption and possible hypoxia-induced brain damage ( 2 , 2026 ) , patients with OSA would be more vulnerable to the effects of these common , mild central nervous system stressors and would experience significantly greater decrements in driving performance . Methods The study was approved by the Human Research Ethics Committees of the Repatriation General Hospital , University of South Australia , and University of Adelaide . Participants were introduced to the study objectives and protocol during an introductory session , gave written informed consent , and were remunerated for their participation . Study Design Patients with OSA and control participants underwent driving simulator assessment s under 3 conditions that were presented in r and om and counterbalanced order : after a normal nighttime sleep , after a single night of sleep restriction ( 4 hours in bed from 2:00 a.m. to 6:00 a.m. ) , and after acute administration of low-dose alcohol ( target blood alcohol concentration , 0.05 g/dL ) . All driving simulator sessions began at 2:00 p.m. and were conducted at least 5 days apart to avoid carryover effects from the previous interventions . Participant Selection Thirty-eight untreated patients with OSA of varying severity were recruited after diagnostic polysomnography . Neither they nor their referring physician had specific concerns about their driving . To minimize selection bias , patients were told that the study objective was to investigate general neurocognitive performance ; they were unaware that the trial measured driving performance until after they agreed to attend an introductory session . Twenty healthy control participants matched for age and sex were recruited from the general population through newspaper advertisements , which only generally described the study and did not mention driving performance measures . Exclusion criteria were employment as a professional driver or shift worker ; history of driving less than 2 years or less than 2 hours per week ; notable medical comorbid conditions ( such as cardiac or respiratory failure ) , periodic limb movement disorder ( periodic limb movement arousal index > 5 per hour ) , or past head injury or depression ; use of alertness-altering prescription medications that may change neurocognitive function ( such as antihistamines , opiates , or antidepressants ) ; and history of alcohol abuse or current use of recreational drugs . Control participants were also excluded if they had higher-than-normal scores on sleep quality and daytime drowsiness question naires . Baseline Measures Before the driving simulator assessment , all participants completed question naires that evaluated general health ( medical conditions , medication , alcohol intake , caffeine \n Output:\n " }, { "from": "agent", "value": "No significant impact of regular therapeutic opioid agonists on people ’s driving-related psychomotor skills was reported ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: A double-blind , parallel group , multicenter clinical trial of pentoxifylline compared with placebo enrolled 150 patients with moderately severe chronic occlusive arterial disease ( COAD ) at three centers in Sc and inavia . The study consisted of a 4 - 6 week single-blind , placebo-controlled run-in phase , during which the stabilization of the initial claudication distance of all patients was assessed before r and omization to a 6-month double-blind observation period . The diagnosis of COAD was established by clinical findings , conventional angiography , and noninvasive peripheral Doppler pressure assessment at rest and after exercise . The results of the overall intention-to-treat analysis of the study population show statistically significant superiority of pentoxifylline over placebo for all absolute claudication distance summary and end point measures . By using two clinical ly relevant parameters , which are a resting ankle/arm pressure ratio 0.8 or less and a duration of COAD for greater than 1 year , a target population could be defined in whom trial results became highly significant . For nontarget patients with mild COAD , we conclude that basic therapeutic measures should include the treatment of risk factors and the initiation of physical training . For target patients , however , a multifactorial therapeutic approach , including the use of pentoxifylline , is justified The influence of the xanthine derivative pentoxifylline ( ' Trental ' or BL191 ; Hoechst-Roussel ) on exercise tolerance was measured in 38 subjects with stable , severe to moderately severe , intermittent claudication who completed a r and omised , double-blind , placebo controlled , cross-over clinical trial . Patients received placebo tablets or 400 mg slow-release pentoxifylline tablets ( ' Trental 400 ' ) twice a day for one week , followed by three times daily for seven weeks , and then crossed over to receive the alternate preparation for another eight weeks . Claudication distance and walking distance were measured on a treadmill before starting treatment and again at four-week intervals during the trial . At the same times , red blood cell filterability , plasma fibrinogen concentration and blood viscosity , resting and post-ischemic calf muscle blood flow , and the resting and post-exercise ankle/brachial systolic pressure ratio were also measured . In this study , the observed effects of pentoxifylline treatment were no greater than those of placebo , even though serum levels of pentoxifylline and its hydroxy-metabolite were within the anticipated range . This was shown by a ' therapeutic effect ratio ' of 0.98 for treadmill claudication distance and 0.96 for treadmill walking distance after within-patient analysis at the end of the cross-over ( where a ratio of 1.0 means the test drug and placebo effects are identical ) . These ratios have 95 % confidence limits of 0.72 - 1.34 and 0.74 - 1.25 , respectively In a r and omized open study , the combination of either prostagl and in E1 ( PGE1 ) or pentoxifylline with controlled vascular training was compared with vascular training alone in patients with peripheral arterial occlusive disease in stage IIb . Forty-four patients were r and omly assigned to treatment either of intensive vascular training alone ( n = 15 ) or in combination with either i.v . pentoxifylline ( 200 mg over 2 hours BID , n = 15 ) or PGE1 ( 40 micrograms over 2 hours BID , n = 14 ) . The basic therapy was a well-defined routine for vascular training , which was identical for all groups . The duration of therapy was 4 weeks . In all three test groups , there was a significant increase in the walking distance . There was a 119 % increase in symptom-free walking distance in the exercise-only group . In comparison with exercise alone , the additional administration of pentoxifylline produced no greater effect ; the increase was 105 % . In contrast , administration of PGE1 combined with exercise achieved a remarkable improvement of 604 % . Between-group comparison revealed the significant superiority of treatment with PGE1 ( P < .05 ) . During the 1-year follow-up , there was a reduction in the walking performance in all groups , albeit of variable extent . In the exercise-only and the pentoxifylline groups , the maintained increase in walking distance was only 30 % compared with baseline values before the beginning of therapy . In the PGE1 group , on the other h and , the maintained improvement was 149 % . Nine of 14 patients were still in stage IIa of peripheral arterial occlusive disease 1 year after PGE1 therapy The efficacy , safety , and tolerance of pentoxifylline ( Trental , Hoechst-Roussel Pharmaceuticals , Inc. ) in the treatment of intermittent claudication associated with chronic occlusive arterial disease ( COAD ) were evaluated in a double-blind , placebo-controlled , parallel-group , multicenter clinical trial involving a total of 128 out patients . The response to treatment was ascertained at regular intervals during the trial by measuring the distance walked prior to the onset of claudication when patients were subjected to a st and ardized treadmill test . Pentoxifylline given orally in doses up to 1200 mg/day was significantly more effective than placebo in increasing both the initial and absolute claudication distances in patients with COAD . Reduction of lower limb paresthesias also suggested greater clinical improvement in the pentoxifylline treated patients . These results support the hypothesis that pentoxifylline reduces blood viscosity by improving red cell flexibility , and thereby enhances blood flow in patients with COAD . White the precise mode of therapeutic action requires clarification , pentoxifylline was well tolerated with minimal unwanted effects A multicenter , prospect i ve , pla cebo-controlled , double-blind trial was conducted to investigate the effi cacy of intravenous infusion therapy with pentoxifylline over fourteen days in patients suffering from angio graphically confirmed chronic pe ripheral occlusive arterial disease , Fontaine stage II , with at least a six- month history . After a washout phase of one week , the patients received in accordance with a r and omization scheme either an i.v . infusion of 300 mg of pentoxifylline ( 15 mL am poules ) or 15 mL of a 0.9 % NaCl so lution in 250 mL of 5 % laevulose , administered over three hours twice daily . The main efficacy parameters were treadmill-assessed initial claudi cation distance ( ICD ) and absolute claudication distance ( ACD ) . Base line testing revealed a mean ICD of 131 m in the pentoxifylline group and 126 m in the placebo cohort ; mean ACD values were 239 m and 225 m respectively . The group of patients treated with pentoxifylline ( n=75 ) displayed a significantly greater i m provement ( p < 0.0001 ) in ICD ( + 70 % ) and ACD ( + 60 % ) than the placebo group did ( + 33 % and 32 % , respectively ) ( n=79 ) . The infusions were well tolerated in both groups The efficacy of pentoxifylline ( PXF ) in severe intermittent claudication was studied comparing PXF and placebo . Patients were r and omized into two treatment plans : PXF ( 2400 mg , four 600-mg tablets daily ) or equivalent placebo was administered for 10 days . The exercise protocol associated with treatment was conducted under supervision . Skin flux ( RF ) was measured at rest and after 1 minute of exercise ( AEF = after exercise flux ; 3 km/hr , 12 % inclination ) with laser Doppler . PO2 and PCO2 were measured at the dorsum of the foot . All 20 included patients completed the study . The two groups were comparable . In the PXF group there was a significant increase in RF , AEF , and in PO2 ( p<0.05 ) ; PCO2 was decreased ( p<0.05 ) . There were also changes in the placebo group , significantly lower than those observed in the PXF group ( p<0.05 ) . In conclusion high-dose PXF treatments improved all microcirculatory parameters in subjects with short-range claudication even with a short period of treatment The effects of a five-week course of haemodilution or pentoxifylline were compared in two matched groups of 10 patients each ( 18 men , 2 women ; mean age 63 [ 47 - 77 ] years ) with peripheral vascular disease of the legs , using clinical findings and Doppler ultrasound measurements as the criteria . Ten patients ( group I ) had six venesections of 400 ml each followed by the injection of 500 ml low-molecular dextran ( 10 % ) , while the other ten ( group II ) received 400 mg pentoxifylline four times daily by mouth after initial intravenous loading . Pain-free and maximal walking distance increased in group I by 139 and 598 m , respectively ( P less than 0.01 ) , and by 155 ( P less than 0.01 ) and 191 m in group II . The greater increase in maximal walking distance in group I was significant as calculated by regression analysis ( P less than 0.05 ) . Only in group I was there a significant prestenotic maximal and effective increase in blood flow velocity ( by 66 % : P less than 0.001 and 68 % : P less than 0.05 , respectively ) , while the poststenotic effective velocity also increased significantly by 66 % ( P less than 0.01 ) . There was no significant change in group II patients The LONFLIT1 and 2 studies established that in high-risk subjects after long ( > 10 hours ) flights , the incidence of deep venous thrombosis ( DVT ) may be between 4 % and 6 % . The LONFLIT3 study aim ed to evaluate methods of prevention in high-risk subjects . Of 467 subjects contacted for the study , 300 were included . These 300 subjects at high risk for DVT were r and omized , after informed consent , into three groups : 1 ) a control group that had no prophylaxis ; 2 ) an aspirin treatment group , in which patients were treated with 400 mg , ( tablets of oral , soluble aspirin ; one dose daily for 3 days , starting 12 hours before the beginning of the flight ) ; and 3 ) a low-molecular-weight heparin ( LMWH ) group , in which one dose of enoxaparine was injected between 2 and 4 hours before the flight . The dose was weight-adjusted ( 1000 IU [ equivalent to 0.1 mL ] per 10 kg of body weight ) . Subjects with potential problems due to prophylaxis with aspirin or LMWH or at risk of drug interactions were excluded . Of the 100 included subjects in each group , a total of 249 subjects completed the study ( dropouts due to low compliance or traveling/connections problems were 17 % ) . Age and sex distribution were comparable in the three groups as well as risk distributions . Mean age was 47 ( range , 28 - 75 ; SD , 11 ; 65 % males ) . Of the 82 subjects in the control group , there were 4.82 % of subjects with DVT with two superficial thromboses . In total 4.8 % of limbs suffered a thrombotic event . Of 84 subjects in the aspirin treatment group , there were 3.6 % of patients with DVT and three superficial thrombosis . In total 3.6 % of limbs had a throm botic event . In the LMWH group ( 82 subjects ) , there were no cases of DVT . One superficial thrombosis was documented . In total only 0.6 % of limbs had a thrombotic event ( p < 0.002 in comparison with the other two groups ) . DVT was asymptomatic in 60 % of subjects ; 85 % of DVTs were observed in passengers in non-aisle seats . Mild gastrointestinal symptoms were reported in 13 % of patients taking aspirin . One dose of LMWH is an important option to consider in high-risk subjects during long-haul flights Peripheral artery disease is associated with altered blood rheologic properties , including increased viscosity and decreased red blood cell ( RBC ) deformability . Pentoxifylline and cilostazol are available therapies for intermittent claudication . Improvement of blood viscosity and erythrocyte deformability have been cited as potential mechanisms of action for pentox ifylline . Cilostazol is a new drug with antiplatelet and vasodilating activity , but the mechanism by which it promotes an improvement in walking is not known . This study was performed to evaluate and compare the hemorheologic effects of pentoxifylline and cilostazol on viscosity , fibrinogen levels , and erythrocyte deformability when administered to adults with moderate to severe claudication . A double-blind , controlled study was conducted and included 59 patients ( 46 male , 13 female ; mean age 65 yr ) r and omized to pentoxifylline 400 mg orally thrice daily ( n=20 ) , cilostazol 100 mg orally twice daily ( n=19 ) , or placebo ( n=20 ) ; all subjects were observed for 24 weeks . Walking ability was assessed before , during , and at the conclusion of treatment by st and ard constant speed , variable grade treadmill testing . Erythrocyte deforma bility was measured by passage of washed RBCs , 10 % hematocrit in phosphate buffered saline ( PBS ) , through a polycarbonate membrane with 4.7 to 5.0 μm pores . Whole blood and plasma viscos \n Output:\n " }, { "from": "agent", "value": "Most included studies suggested improvement in PFWD and TWD for pentoxifylline over placebo and other treatments , but the statistical and clinical significance of findings from individual trials is unclear .\nPentoxifylline generally was well tolerated ; the most commonly reported side effects consisted of gastrointestinal symptoms such as nausea .\nAUTHORS ' CONCLUSIONS Given the generally poor quality of published studies and the large degree of heterogeneity evident in interventions and in results , the overall benefit of pentoxifylline for patients with Fontaine class II intermittent claudication remains uncertain .\nPentoxifylline was shown to be generally well tolerated .\nBased on total available evidence , high- quality data are currently insufficient to reveal the benefits of pentoxifylline for intermittent claudication" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Introduction This study examined the effectiveness of telemedicine in providing psychotherapy to patients with medically unexplained pain ( MUP ) who may not have access to in-person treatment . The impact of Internet-delivered intensive short-term dynamic psychotherapy ( ID-ISTDP ) was investigated for MUP via video teleconferencing ( Skype ™ ) . Methods A r and omized , controlled trial of ISTDP , an evidence -based intervention for MUP , was conducted to compare delivery modalities on variations in MUP symptoms . Eighty-one participants with MUP were r and omized to either ID-ISTDP ( n = 39 ) or in-person ISTDP ( n = 42 ) . Outcome variables included the Numeric Pain Rating Scale , Depression Anxiety Stress Scale-21 , Emotion Regulation Question naire , Mindful Attention Awareness Scale and the Quality of Life Inventory . In addition , exploratory analyses were used to examine acceptability , satisfaction and compliance in both conditions . Participants were assessed prior to intervention , immediately following the intervention , and 12 months after . Results In the intention-to-treat analysis , in-person ISTDP participants had significantly lower pain intensity than ID-ISTDP participants , both immediately following the intervention ( d = 0.97 ) and at the 12-month follow-up ( d = 0.82 ) . Moreover , there were significant decreases in depression , anxiety and stress as well as a greater increase in emotion regulation functioning , mindfulness and quality of life observed in the in-person ISTDP group at the end of the intervention and 12 months after the treatment when compared to the ID-ISTDP group . Participants rated both treatment conditions as equally credible and satisfying . Conclusion ISTDP seems most effective when delivered in person in treating MUP patients with highly comorbid conditions with benefits maintained over 12 months BACKGROUND AND OBJECTIVE Affect and how it is regulated plays a role in pain perception , maintenance of pain , and its resolution . This r and omized , controlled trial evaluated an innovative affective self-awareness ( ASA ) intervention , which was design ed to reduce pain and improve functioning in individuals with fibromyalgia . PARTICIPANTS AND METHODS Forty-five women with fibromyalgia were r and omized to a manualized ASA intervention ( n = 24 ) or wait-list control ( n = 21 ) . The intervention began with a one-time physician consultation , followed by 3 weekly , 2-h group sessions based upon a mind-body model of pain . Sessions focused on structured written emotional disclosure and emotional awareness exercises . Outcomes in both conditions were measured by a blinded assessor at baseline , post-intervention , and 6-month follow-up . MEASURES The primary outcome was pain severity ( Brief Pain Inventory ) ; secondary outcomes included tender-point threshold and physical function ( SF-36 Physical Component Summary ) . Intent-to-treat analyses compared groups on outcomes using analysis of covariance and on the proportion of patients achieving ≥30 % and ≥50 % pain reduction at 6 months . RESULTS Adjusting for baseline scores , the intervention group had significantly lower pain severity ( p < 0.001 ) , higher self-reported physical function ( p < 0.001 ) , and higher tender-point threshold ( p = 0.02 ) at 6 months compared to the control group . From baseline to 6 months , 45.8 % of the ASA intervention group had ≥30 % reduction in pain severity , compared to none of the controls ( p < 0.001 ) . CONCLUSIONS The affective self-awareness intervention improved pain , tenderness , and self-reported physical function for at least 6 months in women with fibromyalgia compared to wait-list control . This study suggests the value of interventions targeting emotional processes in fibromyalgia , although further studies should evaluate the efficacy of this intervention relative to active controls OBJECTIVES Although high levels of distress are associated with the onset and severity of Irritable bowel syndrome ( IBS ) , it is unclear how this relates to emotional processing , particularly in relation to maintenance of symptoms and treatment outcome . This qualitative study embedded within a r and omized controlled trial aim ed to explore how individuals with refractory IBS experience , express , and manage their emotions after either therapist-delivered cognitive behavioural therapy ( TCBT ) or Web-based CBT ( WBCBT ) compared to treatment as usual ( TAU ) . DESIGN Cross-sectional qualitative study . METHODS Fifty-two semi-structured interviews were conducted at post-treatment with 17 TCBT , 17 WBCBT , and 18 TAU participants . The transcripts were analysed using inductive thematic analysis with grounded theory elements . NVivo 11 was used to compare themes across groups . RESULTS Across all groups , high expectations of self was a recurring reason for how participants experienced and expressed their emotions . Three themes with subthemes captured how high expectations related to specific aspects of emotional processing : perceived causes of emotions , strategies for coping with emotions ( bottling up , avoiding emotions , and active coping strategies ) , and the perceived interplay between emotions and IBS symptoms . CONCLUSIONS Patients recognized that their IBS symptoms both triggered and were triggered by negative emotions . However , there was a tendency to bottle up or avoid negative emotions for reasons of social desirability regardless of whether patients had CBT for IBS or not . Future psychological interventions in IBS may benefit from addressing negative beliefs about expressing emotions , promoting assertive emotional expression , and encouraging the experience of positive emotions . Statement of contribution What is already known on this subject ? High levels of distress are consistently associated with both the onset and maintenance of IBS symptoms . Little is known about how this relates to the concept of emotional processing . Preliminary findings suggest a positive correlation between poor emotional processing and IBS . However , further studies need to confirm its role in relation to aetiology , maintenance of symptoms , and response to treatment . What does this study add ? High expectations of self and social desirability seem to be important aspects shaping the way individuals with IBS experience , express , and manage their emotions . Emotional avoidance and bottling up were reported as key strategies to cope with negative emotions . The study revealed that bottling up is not perceived as an all-or-nothing strategy but can be applied selectively depending on the context . Psychological interventions in IBS may benefit from addressing not only illness-related causes of negative emotions but also personal and social triggers of distress OBJECTIVE Current psychological and behavioral therapies for chronic musculoskeletal pain only modestly reduce pain , disability , and distress . These limited effects may be due to the failure of current therapies : a ) to help patients learn that their pain is influenced primarily by central nervous system psychological processes ; and b ) to enhance awareness and expression of emotions related to psychological trauma or conflict . METHODS We developed and conducted a preliminary , uncontrolled test of a novel psychological attribution and emotional awareness and expression therapy that involves an initial individual consultation followed by 4 group sessions . A series of 72 patients with chronic musculoskeletal pain had the intervention and were assessed at baseline , post-treatment , and 6-month follow-up . RESULTS Participation and satisfaction were high and attrition was low . Intent-to-treat analyses found significant improvements in hypothesized change processes : psychological attributions for pain , emotional awareness , emotional approach coping , and alexithymia . Pain , interference , depression , and distress showed large effect size improvements at post-treatment , which were maintained or even enhanced at 6 months . Approximately two-thirds of the patients improved at least 30 % in pain and other outcomes , and one-third of the patients improved 70 % . Changes in attribution and emotional processes predicted outcomes . Higher baseline depressive symptoms predicted greater improvements , and outcomes were comparable for patients with widespread vs. localized pain . CONCLUSION This novel intervention may lead to greater benefits than available psychological interventions for patients with chronic musculoskeletal pain , but needs controlled testing Background Fibromyalgia ( FM ) is a syndrome primarily characterised by chronic , widespread musculoskeletal pain . In the aetiology of this syndrome a crucial role is played by complex interactions among biological , genetic , psychological , and socio-cultural factors . Recently , research ers have started to explore emotional functioning in FM , with their attention focused on alexithymia , a personality construct that affects the regulation of a person ’s own emotions . On the other h and , the detection and experience of emotional signals from other people have only been sparsely investigated in FM syndrome and no studies have investigated the ability to represent other people ’s mental states ( i.e. Theory of Mind , ToM ) in these patients . Here we present the first study investigating a large set of social-cognitive abilities , and the possible relationships between these abilities and the performance on executive-function tasks , in a homogenous sample of patients with FM . Methodology Forty women with FM and forty-one healthy women matched for education and age were involved in the study . Social cognition was assessed with a set of vali date d experimental tasks . Measures of executive function were used to test the correlations between this dimension and the social-cognitive profile of patients with FM . Relationships between social-cognitive abilities and demographic , clinical and psychological variables were also investigated . Principal Findings Patients with FM have impairments both in the regulation of their own affect and in the recognition of other ’s emotions , as well as in representing other people ’s mental states . No significant correlations were found between social cognition tasks and the subcomponents of the executive function that were analysed . Conclusions The results show the presence of several impairments in social cognition skills in patients with FM , which are largely independent of both executive function deficits and symptoms of psychological distress . The impairments reported highlight the importance of adequately assessing ToM and emotional functioning in clinical practice OBJECTIVE The present study examines the possibility that a chronic pain condition , such as fibromyalgia , was associated with deficits in decision making and associative learning . METHODS Fifteen patients with fibromyalgia ( aged 42 - 59 years ) and 15 healthy controls ( aged 39 - 61 years ) participated in the experiment . Subjects completed anxiety ( STAI ) and depression ( BDI ) question naires , as well as st and ardized neuropsychological tests ( Stroop and WAIS subscales ) . In addition , an emotional decision-making task ( Iowa Gambling Task ) and a conditional associative learning task ( CALT ) were administered to all participants . RESULTS Results indicated that fibromyalgia had a poorer performance than healthy controls in both tasks , showing more perseveration errors in the learning task , and more disadvantageous decisions , as well as a more r and om behavior in the gambling task . Moreover , we observed that poor performance on the associative learning task was mediated by depression , whereas performance on the gambling task was not influenced by depression . No group differences were found on the st and ardized neuropsychological tests . CONCLUSION These findings indicate that pain and depressive symptoms in fibromyalgia might lead to significant deficits in emotionally charged cognitive tasks . Furthermore , it suggests that chronic pain might impose a high cost on executive control , undermining mainly affective processes involved in learning , memory , attention , and decision-making Summary Within‐day associations between behavioral anger expression and momentary chronic pain intensity show significant lagged effects , with elevated behavioral anger expression linked to greater subsequent pain intensity . ABSTRACT Links between elevated trait anger expressiveness ( anger‐out ) and greater chronic pain intensity are well documented , but pain‐related effects of expressive behaviors actually used to regulate anger when it is experienced have been little explored . This study used ecological momentary assessment methods to explore prospect i ve associations between daily behavioral anger expression and daily chronic pain intensity . Forty‐eight chronic low back pain ( LBP ) patients and 36 healthy controls completed electronic diary ratings of momentary pain and behavioral anger expression in response to r and om prompts 4 times daily for 7 days . Across groups , greater trait anger‐out was associated with greater daily behavioral anger expression ( P < 0.001 ) . LBP participants showed higher levels of daily anger expression than controls ( P < 0.001 ) . Generalized estimating equation analyses in the LBP group revealed a lagged main effect of greater behavioral anger expression on increased chronic pain intensity in the subsequent assessment period ( P < 0.05 ) . Examination of a trait × situation model for anger‐out revealed prospect i ve associations between elevated chronic pain intensity and later increases in behavioral anger expression that were restricted largely to individuals low in trait anger‐out ( P < 0.001 ) . Trait × situation interactions for trait anger suppression ( anger‐in ) indicated similar influences of pain intensity on subsequent behavioral anger expression occurring among low anger‐in persons ( P < 0.001 ) . Overlap with trait and state negative affect did not account for study findings . This study for the first time documents lagged within‐day influences of behavioral anger expression on subsequent chronic pain intensity . Trait anger regulation style may moderate associations between behavioral anger expression and chronic pain intensity It is now widely accepted that individuals with autism have a Theory of Mind ( ToM ) or mentalizing deficit . This has traditionally been assessed with false‐belief tasks and , more recently , with silent geometric animations , an on‐line ToM task . In adults with milder forms of autism st and ard false‐belief tests , originally devised for children , often prove insensitive , while the Frith‐Happé animations have had rather better success at capturing the on‐line ToM deficit in this population . However , analysis of participants ' verbal descriptions of these animations , which span scenarios from “ R and om ” to “ Goal ‐Directed ” and “ ToM , ” is time consuming and subjective . In this study , we developed and established the feasibility of an objective method of response through a series of multiple‐choice questions . Sixteen adults with aut \n Output:\n " }, { "from": "agent", "value": "The results indicate that patients show a reduced engagement with cognitive content of emotions .\nOn the other h and , bodily constituents of ER seem to depict an over-reactive pattern .\nSimilarly , the patients tend to encounter difficulties in flexibly disengaging their ( spontaneous ) attention from emotional material ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE Referral for colposcopy because of abnormal Pap test results is likely to be distressing , but the extent and duration of these effects are unknown . We aim ed to fill this gap . METHODS We conducted a prospect i ve observational study at two departments of Obstetrics and Gynecology ( an academic and a non-academic setting ) . Women referred for colposcopy completed question naires before colposcopy , and at 1 , 3 , and 6 months afterwards . A reference group of 706 screen participants , aged 29 - 60 years old , was included and completed question naires once . Main outcome measures were generic health-related quality of life ( HRQoL ) , assessed through the EQ-5D and the SF-12 physical and mental scores ( PCS-12 and MCS-12 ) ; anxiety as assessed by STAI-6 , and screen-specific anxiety as assessed by the psychological consequences question naire ( PCQ ) . RESULTS 154 women responded to the question naire , of whom 132 were included in the analyses . Histological results were CIN 1 in 17/115 women ( 15 % ) and CIN 2 + in 62 ( 54 % ) . In 36 women ( 31 % ) there was no histologically confirmed neoplasia . Before colposcopy physical HRQoL scores were similar or slightly better than in the reference group , while mental HRQoL ( MSC-12 ) and ( screen-specific ) anxiety were worse ( p<0.001 ) . Irrespective of CIN- grade s , anxiety washed out during follow-up ( p<0.001 ) , with changes being clinical ly relevant . CONCLUSIONS Referral for gynecological evaluation because of abnormal PAP-test results was distressing . Anxiety-- and not the physical burden of management -- seemed to be the most bothersome to women . For all CIN- grade s , distress disappeared over six months following colposcopy , suggesting a reassuring effect of gynecological management BACKGROUND Data on the impact of abnormal cervical smear results on health-related quality of life ( HrQoL ) are scarce . We aim ed to ( i ) prospect ively assess the HrQoL of women who were informed of an abnormal smear result ; ( ii ) identify predictors of greater negative psychosocial impact of an abnormal result ; and ( iii ) prospect ively estimate the quality -adjusted life-years ( QALYs ) lost following an abnormal result . METHODS Between 08/2006 and 08/2008 , 492 women with an abnormal result and 460 women with a normal result , frequency matched for age and clinic , were recruited across Canada . HrQoL was measured at recruitment and 4 and 12 weeks later with the EuroQol , Short Form-12 , short Spielberg State-Trait Anxiety Inventory ( STAI ) and HPV Impact Profile . Three blocks of potential predictors of higher psychosocial impact were tested by hierarchical modeling : ( i ) socio-demographics ; ( ii ) sexual activity ; and ( iii ) smear result severity , communication , and underst and ing . RESULTS Receiving an abnormal result significantly increased anxiety ( STAI mean difference between both groups = 8.3 ) . Initial anxiety decreased over time for the majority of women . However , 35 % of women had clinical ly meaningful anxiety at 12 weeks ( i.e. STAI scores ≥0.5 st and ard deviation of the controls ) . These women reported a lower socio-economic level , did not completely underst and the information about their result and perceived themselves at higher risk of cancer . QALY lost following an abnormal result were between 0.007 and 0.009 . CONCLUSIONS Receiving an abnormal smear has a statistically significant and clinical ly meaningful negative impact on mental health . However , this negative impact subsides after 12 weeks for the majority of women State anxiety ( S-STAI-6 ) , distress ( GHQ-12 ) , concern and quality of life ( EuroQoL-EQ-5D ) 6 months after human papillomavirus ( HPV ) testing in women with borderline or mildly dyskaryotic smear test results were assessed based on a prospect i ve question naire study , with 6-month follow-up after the smear test result . Two centres participated in an English pilot study of HPV testing . Participants included two groups of women receiving abnormal smear test results : ( tested for HPV and found to be ( a ) HPV positive ( n=369 ) or ( b ) HPV negative ( n=252 ) ) and two groups not tested for HPV ( those receiving ( c ) abnormal smear test results ( n=102 ) or ( d ) normal smear test results ( n=288 ) ) . There were no differences in anxiety , distress or health-related quality of life between the four study groups at 6 months . Levels of concern about the smear test result remained elevated in all groups receiving an abnormal smear test result , and were highest in the group untested for HPV . Predictors of concern across all groups receiving an abnormal smear test were perceived risk of developing cancer , being HPV positive or untested for HPV , sexual health worries and the smear being a woman 's first smear test . The raised anxiety and distress observed in women immediately after being informed of an abnormal smear test result and that they are HPV positive was no longer evident at 6 months . Concern about the smear test result was however still raised in these women and those who tested negative for HPV , and particularly among those who did not undergo HPV testing CONTEXT Every year approximately 2 million US women are diagnosed as having a cervical cytological result of atypical squamous cells of undetermined significance ( ASC-US ) . OBJECTIVE To determine the most efficient and cost-effective management strategy for women in the United States diagnosed as having ASC-US . DESIGN AND SETTING Cost-effectiveness analysis of data from clinical trials , prospect i ve studies , and other published literature . A computer-based model was used to compare 4 management strategies for a cytological result of ASC-US : immediate colposcopy ; human papillomavirus ( HPV ) triage , which includes colposcopy if high-risk HPV types are detected ; repeat cytology , which includes follow-up cytology at 6 and 12 months and referral for colposcopy if a repeat abnormal result occurs ; and reclassifying ASC-US as normal in which a cytological result of ASC-US is ignored . Reflex HPV DNA testing uses either residual liquid-based cytological specimens or sample s co-collected at the time of the initial screening for conventional cytology . Another method , referred to as the 2-visit HPV DNA triage , requires a woman with an ASC-US result to return within 1 month to provide another speciman sample . MAIN OUTCOME MEASURES Years of life saved ( YLS ) , quality -adjusted life-years ( QALYs ) , and incremental cost-effectiveness ratios . RESULTS The least costly strategy for biennial screening was to reclassify ASC-US as normal , result ing in a reduction in total cancer incidence of 75 % for conventional cytology and 84 % for liquid-based cytology compared with no screening . The next least costly strategy was HPV DNA testing result ing in a reduction in total cancer incidence of 86 % for conventional cytology and 90 % for liquid-based cytology , followed by immediate colposcopy with a reduction of 87 % and 91 % , respectively . Compared with reflex HPV DNA testing , a strategy of repeat cervical cytology or delayed HPV testing costs more but is less effective . When all strategies were compared simultaneously , varying frequency and type of cytological test , biennial ( vs every 3 years ) liquid-based cytology with reflex HPV testing had a cost of $ 174 200 per YLS . In a similar comparison , liquid-based cytology with reflex HPV testing conducted every 3 years ( vs every 5 years ) had a cost of $ 59 600 per YLS and was more effective and less costly than a strategy of conventional cytology incorporating repeat cytology or immediate colposcopy conducted biennially . CONCLUSION Reflex HPV DNA testing provides the same or greater life expectancy benefits and is more cost-effective than other management strategies for women diagnosed as having ASC-US OBJECTIVE To evaluate health-related quality of Life ( HRQoL ) in patients with abnormal cervical cytology referred for colposcopy . STUDY DESIGN An observational study with prospect i ve and retrospective cohorts . In the prospect i ve arm 240 women referred for colposcopy filled in the 15D HRQoL and the State Anxiety Inventory ( STAI ) question naires and were followed up for 12 months . In the retrospective arm 208 patients who had been treated for cervical dysplasia eight years earlier filled in the 15D HRQoL question naire . Results were compared with the age- and sex-st and ardized general population . RESULTS In the prospect i ve part of the study , the mean 15D score of the patients did not differ from that of the general population . On the dimensions of sleeping , distress and sexual activity , however , the patients scored lower than the general population ( p<0.001 ) . Patients with higher levels of anxiety at baseline , according to the STAI question naire , had lower HRQoL during the whole 12-month observation period ( p<0.001 ) . The overall HRQoL score of the patients treated for cervical dysplasia eight years earlier did not differ from that of the general population . CONCLUSIONS Abnormal cytology and referral for colposcopy were associated with anxiety and slightly impaired psychosocial components of HRQoL but did not reduce the overall HRQoL. High anxiety levels at baseline were associated with impaired HRQoL. Previous treatment for cervical dysplasia was not associated with impaired overall Cervical screening reduces the risk of cervical cancer by detecting and treating cervical intraepithelial neoplasia ( CIN ) . The management of women with low- grade cervical abnormalities is controversial . Two management policies exist : repeat smears in primary care and colposcopy examination . It is not clear which of these is the more effective and efficient . There is also uncertainty as to the most effective and efficient management of women at colposcopy when an area of abnormality is seen on the cervix - immediate treatment or biopsy and selective recall for treatment if the biopsy result suggests this is necessary . The result of a human papillomavirus ( HPV ) test might assist in deciding the appropriate management of women with low- grade abnormalities . TOMBOLA , a pragmatic r and omised-controlled trial set within the cervical screening programmes in Scotl and and Engl and , addresses these three areas of uncertainty . Almost four and a half thous and women aged 20 - 59 with a low- grade cervical abnormality have been recruited and r and omised to either repeat smears or colposcopy examination . Women in the colposcopy arm of the trial are further r and omised to a policy of either immediate treatment or biopsy and selective recall for treatment if they have an abnormal transformation zone . Women are followed up to an exit examination at 3 years . HPV testing is undertaken at recruitment and at the exit examination . The primary endpoint is cumulative incidence of CIN2/3 . A range of other clinical , psychosocial and economic outcomes is being considered . This paper describes the design of the trial , and discusses the rationale underlying aspects of the design and the challenges faced in design ing and implementing the trial Abstract Objectives Genital human papillomavirus ( HPV ) infections and associated precancerous lesions adversely affect health-related quality of life ( HRQoL ) . HPV vaccines provide effective protection against these conditions . We therefore investigated the impact of HPV vaccination on HRQoL in young women five years after participation in a phase III HPV vaccination trial . Methods A total of 4808 originally 16- to 17-year-old Finnish girls had participated in the PATRICIA trial and received either bivalent HPV 16/18 vaccine or hepatitis A-virus ( HAV ) vaccine in 2004 to 2005 . Unvaccinated girls ( n = 9602 ) , from adjacent birth cohorts , had participated in the control cohort in 2005 . From 2009 to 2011 , at 22 to 23 years of age , all participants received a question naire consisting of two generic HRQoL instruments ( R AND 36 and EQ VAS ) and a disease-specific question naire ( CECA10 ) . Results We analysed responses of 1143 HPV 16/18-vaccinated , 980 HAV-vaccinated , and 3753 unvaccinated young women . The unadjusted mean outcome measures of the different HRQoL estimates were similar in the three different responder cohorts . Conclusions Five years after vaccination the health-related quality of life of HPV 16/ 18- vaccinated young women did not differ from those of HAV-vaccinated or unvaccinated controls representing the general population BACKGROUND Cervical intraepithelial neoplasia grade 2 or greater ( CIN2 + ) is the surrogate endpoint used in licensure trials of human papillomavirus ( HPV ) vaccines . Vaccine efficacy against CIN3 + , the immediate precursor to invasive cervical cancer , is more difficult to measure because of its lower incidence , but provides the most stringent evidence of potential cancer prevention . We report vaccine efficacy against CIN3 + and adenocarcinoma in situ ( AIS ) in the end-of- study analysis of PATRICIA ( PApilloma TRIal against Cancer In young Adults ) . METHODS Healthy women aged 1 \n Output:\n " }, { "from": "agent", "value": "Conclusions Our results reveal the challenges of sourcing reliable estimates of HRQoL for use in CEAs of cervical cancer prevention and treatment .\nThe EQ-5D appears insufficiently sensitive for some health states .\nA more general problem is the paucity of HRQoL estimates for many health states and their change over time" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: CONTEXT The herbal product Ginkgo biloba is taken frequently with the intention of improving cognitive health in aging . However , evidence from adequately powered clinical trials is lacking regarding its effect on long-term cognitive functioning . OBJECTIVE To determine whether G. biloba slows the rates of global or domain-specific cognitive decline in older adults . DESIGN , SETTING , AND PARTICIPANTS The Ginkgo Evaluation of Memory ( GEM ) study , a r and omized , double-blind , placebo-controlled clinical trial of 3069 community-dwelling participants aged 72 to 96 years , conducted in 6 academic medical centers in the United States between 2000 and 2008 , with a median follow-up of 6.1 years . INTERVENTION Twice-daily dose of 120-mg extract of G. biloba ( n = 1545 ) or identical-appearing placebo ( n = 1524 ) . MAIN OUTCOME MEASURES Rates of change over time in the Modified Mini-Mental State Examination ( 3MSE ) , in the cognitive subscale of the Alzheimer Disease Assessment Scale ( ADAS-Cog ) , and in neuropsychological domains of memory , attention , visual-spatial construction , language , and executive functions , based on sums of z scores of individual tests . RESULTS Annual rates of decline in z scores did not differ between G. biloba and placebo groups in any domains , including memory ( 0.043 ; 95 % confidence interval [ CI ] , 0.034 - 0.051 vs 0.041 ; 95 % CI , 0.032 - 0.050 ) , attention ( 0.043 ; 95 % CI , 0.037 - 0.050 vs 0.048 ; 95 % CI , 0.041 - 0.054 ) , visuospatial abilities ( 0.107 ; 95 % CI , 0.097 - 0.117 vs 0.118 ; 95 % CI , 0.108 - 0.128 ) , language ( 0.045 ; 95 % CI , 0.037 - 0.054 vs 0.041 ; 95 % CI , 0.033 - 0.048 ) , and executive functions ( 0.092 ; 95 % CI , 0.086 - 0.099 vs 0.089 ; 95 % CI , 0.082 - 0.096 ) . For the 3MSE and ADAS-Cog , rates of change varied by baseline cognitive status ( mild cognitive impairment ) , but there were no differences in rates of change between treatment groups ( for 3MSE , P = .71 ; for ADAS-Cog , P = .97 ) . There was no significant effect modification of treatment on rate of decline by age , sex , race , education , APOE*E4 allele , or baseline mild cognitive impairment ( P > .05 ) . CONCLUSION Compared with placebo , the use of G. biloba , 120 mg twice daily , did not result in less cognitive decline in older adults with normal cognition or with mild cognitive impairment . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00010803 Soybean-derived phosphatidylserine ( Soy-PS ) is a phosphatidylserine made from soybean lecithin by enzymatic reaction with L-serine . A double-blind , r and omized controlled study was conducted to investigate the effects of Soy-PS on the cognitive functions of the elderly Japanese subjects with memory complaints . Seventy-eight elderly people with mild cognitive impairment ( 50–69 years old ) were r and omly allocated to take Soy-PS ( 100 mg , 300 mg/day ) or placebo for 6 months . As a result , there was no difference in blood markers and vital signs during Soy-PS treatment and any side effect caused by Soy-PS treatment was not observed . Neuropsychological test scores were similarly increased in all groups including placebo group . However , in the subjects with relatively low score at baseline , the memory scores in PS treated groups were significantly increased against the baseline , while those of placebo group remained unchanged . And the memory improvements in Soy-PS-treated groups were mostly attributed to the increase in delayed verbal recall , a memory ability attenuated in the earliest stage of dementia . In conclusion , Soy-PS used in this study is considered as safety food ingredient and 6 months of Soy-PS supplementation could improve the memory functions of the elderly with memory complaints BACKGROUND Despite widespread use of multivitamin supplements , their effect on cognitive health-a critical issue with aging-remains inconclusive . To date , no long-term clinical trials have studied multivitamin use and cognitive decline in older persons . OBJECTIVE To evaluate whether long-term multivitamin supplementation affects cognitive health in later life . DESIGN R and omized , double-blind , placebo-controlled trial of a multivitamin from 1997 to 1 June 2011 . The cognitive function sub study began in 1998 . Up to 4 repeated cognitive assessment s by telephone interview were completed over 12 years . ( Clinical Trials.gov : NCT00270647 ) SETTING : The Physicians ' Health Study II . PATIENTS 5947 male physicians aged 65 years or older . INTERVENTION Daily multivitamin or placebo . MEASUREMENTS A global composite score averaging 5 tests of global cognition , verbal memory , and category fluency . The secondary end point was a verbal memory score combining 4 tests of verbal memory , which is a strong predictor of Alzheimer disease . RESULTS No difference was found in mean cognitive change over time between the multivitamin and placebo groups or in the mean level of cognition at any of the 4 assessment s. Specifically , for the global composite score , the mean difference in cognitive change over follow-up was -0.01 SU ( 95 % CI , -0.04 to 0.02 SU ) when treatment was compared with placebo . Similarly , cognitive performance did not differ between the multivitamin and placebo groups on the secondary outcome , verbal memory ( mean difference in cognitive change over follow-up , -0.005 SU [ CI , -0.04 to 0.03 SU ] ) . LIMITATION Doses of vitamins may be too low or the population may be too well-nourished to benefit from a multivitamin . CONCLUSION In male physicians aged 65 years or older , long-term use of a daily multivitamin did not provide cognitive benefits . PRIMARY FUNDING SOURCE National Institutes of Health , BASF , Pfizer , and DSM Nutritional Products BACKGROUND Prior investigations have reported a link between poor status of antioxidants , folate , and cobalamin result ing in elevated total plasma homocysteine ( tHcy ) and methylmalonic acid ( MMA ) concentrations with an increased risk for reduced cognitive performance . The aim of the study was to evaluate the effect of a 6-month multivitamin supplementation on the cognitive performance of female seniors and to assess cognitive functioning in relation to vitamin status , tHcy , and MMA values at baseline . METHODS The study was performed as a r and omized placebo-controlled double-blind trial . 220 healthy , free-living women ( aged 60 - 91 years ) were included . Blood drawings and cognitive tests were performed at the Institute of Food Science of the University of Hanover , Germany . Vitamin and cognitive status have been evaluated prior to and 6 months after supplementation . Plasma ascorbic acid , serum concentrations of alpha-tocopherol , beta-carotene , and coenzyme Q10 , serum and erythrocyte folate as well as serum cobalamin , serum MMA , and plasma tHcy concentrations were measured . Activity coefficient of erythrocyte alpha aspartic aminotransferase was used as functional index for vitamin B(6 ) status . The cognitive performance was assessed by the Symbol Search test , a subtest of the Wechsler Adult Intelligence Scale ( WAIS-III ) and the pattern-recognition test . Intelligence as assessed by the ' Kurztest für Allgemeine Intelligenz ' ( KAI ) was a further variable . RESULTS No significant differences in pattern-recognition and intelligence score were observed between vitamin and placebo group prior to and after multivitamin supplementation . In the Symbol Search test , the vitamin group exhibited better test results than the placebo group at both measure points . One-way ANOVA showed a marginally significant linear trend between the baseline tHcy concentration and the pattern-recognition score ( P = 0.051 ) in the total sample . Multiple backward regression revealed only a significant influence of the school graduation on baseline cognitive function test results . A general linear model showed that the changes in cognitive function scores could not be explained by the type of treatment or blood parameters . CONCLUSIONS Our data indicate that 6 months supplementation of physiological dosages of antioxidants and B vitamins have no effect on cognitive performance in presumedly healthy and well-nourished female seniors . An intervention period of only 6 months may be too short for improving cognitive performance in well-educated elderly women without dementia Background Observational studies have frequently reported an association between cognitive function and nutrition in later life but r and omised trials of B vitamins and antioxidant supplements have mostly found no beneficial effect . We examined the effect of daily supplementation with 11 vitamins and 5 minerals on cognitive function in older adults to assess the possibility that this could help to prevent cognitive decline . Methods The study was carried out as part of a r and omised double blind placebo controlled trial of micronutrient supplementation based in six primary care health centres in North East Scotl and . 910 men and women aged 65 years and over living in the community were recruited and r and omised : 456 to active treatment and 454 to placebo . The active treatment consisted of a single tablet containing eleven vitamins and five minerals in amounts ranging from 50–210 % of the UK Reference Nutrient Intake or matching placebo tablet taken daily for 12 months . Digit span forward and verbal fluency tests , which assess immediate memory and executive functioning respectively , were conducted at the start and end of the intervention period . Risk of micronutrient deficiency at baseline was assessed by a simple risk question naire . Results For digit span forward there was no evidence of an effect of supplements in all participants or in sub-groups defined by age or risk of deficiency . For verbal fluency there was no evidence of a beneficial effect in the whole study population but there was weak evidence for a beneficial effect of supplementation in the two pre-specified subgroups : in those aged 75 years and over ( n 290 ; mean difference between supplemented and placebo groups 2.8 ( 95 % CI -0.6 , 6.2 ) units ) and in those at increased risk of micronutrient deficiency assessed by the risk question naire ( n 260 ; mean difference between supplemented and placebo groups 2.5 ( 95 % CI -1.0 , 6.1 ) units ) . Conclusion The results provide no evidence for a beneficial effect of daily multivitamin and multimineral supplements on these domains of cognitive function in community-living people over 65 years . However , the possibility of beneficial effects in older people and those at greater risk of nutritional deficiency deserves further attention Is it possible to prevent atrophy of key brain regions related to cognitive decline and Alzheimer ’s disease ( AD ) ? One approach is to modify nongenetic risk factors , for instance by lowering elevated plasma homocysteine using B vitamins . In an initial , r and omized controlled study on elderly subjects with increased dementia risk ( mild cognitive impairment according to 2004 Petersen criteria ) , we showed that high-dose B-vitamin treatment ( folic acid 0.8 mg , vitamin B6 20 mg , vitamin B12 0.5 mg ) slowed shrinkage of the whole brain volume over 2 y. Here , we go further by demonstrating that B-vitamin treatment reduces , by as much as seven fold , the cerebral atrophy in those gray matter ( GM ) regions specifically vulnerable to the AD process , including the medial temporal lobe . In the placebo group , higher homocysteine levels at baseline are associated with faster GM atrophy , but this deleterious effect is largely prevented by B-vitamin treatment . We additionally show that the beneficial effect of B vitamins is confined to participants with high homocysteine ( above the median , 11 µmol/L ) and that , in these participants , a causal Bayesian network analysis indicates the following chain of events : B vitamins lower homocysteine , which directly leads to a decrease in GM atrophy , thereby slowing cognitive decline . Our results show that B-vitamin supplementation can slow the atrophy of specific brain regions that are a key component of the AD process and that are associated with cognitive decline . Further B-vitamin supplementation trials focusing on elderly subjets with high homocysteine levels are warranted to see if progression to dementia can be prevented Background — Cardiovascular factors are associated with cognitive decline . Antioxidants may be beneficial . Methods and Results — The Women ’s Antioxidant Cardiovascular Study was a trial of vitamin E ( 402 mg every other day ) , beta carotene ( 50 mg every other day ) , and vitamin C ( 500 mg daily ) for the secondary prevention of cardiovascular disease . From 19 \n Output:\n " }, { "from": "agent", "value": "Overall , studies provided low-strength evidence suggesting that -3 fatty acids do not improve cognitive performance in adults with normal cognition compared with placebo ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Prognosis studies are investigations of future events or the evaluation of associations between risk factors and health outcomes in population s of patients ( 1 ) . The results of such studies improve our underst and ing of the clinical course of a disease and assist clinicians in making informed decisions about how best to manage patients . Prognostic research also informs the design of intervention studies by helping define subgroups of patients who may benefit from a new treatment and by providing necessary information about the natural history of a disorder ( 2 ) . There has recently been a rapid increase in the use of systematic review methods to synthesize the evidence on research questions related to prognosis . It is essential that investigators conducting systematic review s thoroughly appraise the method ologic quality of included studies to be confident that a study 's design , conduct , analysis , and interpretation have adequately reduced the opportunity for bias ( 3 , 4 ) . Caution is warranted , however , because inclusion of method ologically weak studies can threaten the internal validity of a systematic review ( 4 ) . This follows abundant empirical evidence that inadequate attention to biases can cause invalid results and inferences ( 5 - 9 ) . However , there is limited consensus on how to appraise the quality of prognosis studies ( 1 ) . A useful framework to assess bias in such studies follows the basic principles of epidemiologic research ( 10 , 11 ) . We focus on 6 areas of potential bias : study participation , study attrition , prognostic factor measurement , confounding measurement and account , outcome measurement , and analysis . The main objectives of our review of review s are to describe methods used to assess the quality of prognosis studies and to describe how well current practice s assess potential biases . Our secondary objective is to develop recommendations to guide future quality appraisal , both within single studies of prognostic factors and within systematic review s of the evidence . We hope this work facilitates future discussion and research on biases in prognosis studies and systematic review s. Methods Literature Search and Study Selection We identified systematic review s of prognosis studies by search ing MEDLINE ( 1966 to October 2005 ) using the search strategy recommended by McKibbon and colleagues ( 12 ) . This strategy combines broad search terms for systematic review s ( systematic review .mp ; meta- analysis .mp ) and a sensitive search strategy for prognosis studies ( cohort , incidence , mortality , follow-up studies , prognos * , predict * , or course ) . We also search ed the reference lists of included review s and method ologic papers to identify other relevant publications . We restricted our search to English- language publications . One review er conducted the search and selected the studies . Systematic review s , defined as review s of published studies with a comprehensive search and systematic selection , were included if they assessed the method ologic quality of the included studies by using 1 or more explicit criteria . We excluded studies if they were meta-analyses of independent patient data only , if their primary goal was to investigate the effectiveness of an intervention or specific diagnostic or screening tests , or if they included studies that were not done on humans . Data Extraction and Synthesis Individual items included in the quality assessment of the systematic review s were recorded as they were reported in the publication ( that is , the information that would be available to readers and future review ers ) . We review ed journal Web sites and contacted the authors of the systematic review s for additional information when authors made such an offer in their original papers . When review s assessed different study design s by using different sets of quality items , we extracted only those items used to assess cohort studies . We constructed a comprehensive list of distinct items that the review s used to assess the quality of their included studies . The full text of each review was screened . All items used by the review authors to assess the quality of studies were extracted into a computerized spreadsheet by 1 review er . Two experienced review ers , a clinical epidemiologist and an epidemiologist , independently synthesized the quality items extracted from the prognosis review s to determine how well the systematic review s assessed potential biases . We did this in 3 steps : 1 ) identified distinct concepts or domains addressed by the quality items ; 2 ) grouped each extracted quality item into the appropriate domain or domains ; and 3 ) identified the domains necessary to assess potential biases in prognosis studies . We then used this information to assess how well the review s ' quality assessment included items from the domains necessary to assess potential biases . After completing each of the first 3 steps , the review ers met to attempt to reach a consensus . The consensus process involved each review er presenting his or her observations and results , followed by discussion and debate . A third review er was available in cases of persistent disagreement or uncertainty . In the first step , all domains addressed by the quality items were identified . The first review er iteratively and progressively defined the domains as items were extracted from the included review s. The second review er defined domains from a r and om list of all extracted quality items . Limited guidance was provided to the review ers so that their assessment s and definitions of domains would be independent . The review ers agreed on a final set of domains that adequately and completely defined all of the extracted items . In the second step , review ers independently grouped each extracted item into the appropriate domains . Review ers considered each extracted item by asking , What is each particular quality item addressing ? or What are the review 's authors getting at with the particular quality assessment item ? . Items were grouped into the domain or domains that best represented the concepts being addressed . For example , the extracted items at least 80 % of the group originally identified was located for follow-up and follow-up was sufficiently complete or does n't jeopardize validity were each independently classified by both review ers as assessing the domain completeness of follow-up adequate , whereas the extracted item quantification and description of all subjects lost to follow-up was classified as assessing the domain completeness of follow-up described . In the third step , we identified the domains necessary to assess potential biases . Each review er considered the ability of the identified domains to adequately address , at least in part , 1 of the following 6 potential biases : 1 ) study participation , 2 ) study attrition , 3 ) prognostic factor measurement , 4 ) confounding measurement and account , 5 ) outcome measurement , and 6 ) analysis . Domains were considered to adequately address part of the framework if information garnered from that domain would inform the assessment of potential bias . For example , both review ers judged that the identified domain study population represents source population or population of interest assessed potential bias in a prognosis study , whereas the domain research question definition did not , although the latter is an important consideration in assessing the inclusion of studies in a systematic review . Finally , on the basis of our previous ratings , we looked at whether each review included items from the domains necessary to assess the 6 potential biases . We calculated the frequency of systematic review s by assessing each potential bias and the number of review s that adequately assessed bias overall . From this systematic synthesis , we developed recommendations for improving quality appraisal in future systematic review s of prognosis studies . We used Microsoft Access and Excel 2002 ( Microsoft Corp. , Redmond , Washington ) for data management and SAS for Windows , version 9.1 ( SAS Institute , Inc. , Cary , North Carolina ) for descriptive statistics . Role of the Funding Sources The funding sources , the Canadian Institutes of Health Research , the Canadian Chiropractic Research Foundation , the Ontario Chiropractic Association , and the Ontario Ministry of Health and Long Term Care , did not have a role in the collection , analysis , or interpretation of the data or in the decision to su bmi t the manuscript for publication . Results We identified 1384 potentially relevant articles . Figure 1 shows a flow chart of studies that were included and excluded . Figure 2 shows the number of review s identified by year of publication . We excluded 131 systematic review s of prognosis studies that did not seem to include any quality assessment of the included studies ; this represented 44 % of prognosis review s. We included 163 review s of prognosis studies in our analysis ( 13 - 175 ) . The most common topics were cancer ( 15 % ) , musculoskeletal disorders and rheumatology ( 13 % ) , cardiovascular ( 10 % ) , neurology ( 10 % ) , and obstetrics ( 10 % ) . Other review s included a wide range of health and health care topics . Sixty-three percent of the review s investigated the association between a specific prognostic factor and a particular outcome ; the remainder investigated multiple prognostic factors or models . The number of primary studies included in each systematic review ranged from 3 to 167 ( median , 18 [ interquartile range , 12 to 31 ] ) . A complete description of the included review s is available from the authors on request . Figure 1 . Flow diagram of inclusion and exclusion criteria of systematic review s. Figure 2 . Number of systematic review s of prognosis studies identified over time . Quality Items One hundred fifty-three review s provided adequate detail to allow extraction of quality items . Eight hundred eighty-two distinct quality items were extracted from the review s. Most review s developed their own set of quality items , with only a few applying criteria from previous review s. Most quality items BACKGROUND Severity scores are useful to guarantee similar disease severity among groups in clinical trials and to enable comparison between different studies . The aim of this study was to assess the performance of the third generation models of severity scoring systems [ simplified acute physiology score ( SAPS ) 3 , acute physiology and chronic health evaluation ( APACHE ) IV and mortality probability model (MPM)-III ] in acute kidney injury ( AKI ) patients in the intensive care unit ( ICU ) . METHODS Three hundred and sixty-six consecutive AKI critically ill patients were prospect ively assessed in six ICUs of an academic tertiary care center . Scores were applied on AKI diagnosis day ( DD ) and on the day of nephrology consultation ( NCD ) . Discrimination was assessed by area under the receiver operating characteristic curve ( AUCROC ) and calibration by Hosmer-Lemeshow ( HL ) goodness-of-fit test . RESULTS Hospital mortality rate was 67.8 % . SAPS 3 general and Central and South America ( CSA ) customized equations presented identical good discrimination ( AUCROC curve : 0.80 on NCD ) and satisfactory HL tests on both analyzed days ( P > 0.100 ) . CSA SAPS 3 equation predicted mortality more accurately [ st and ardized mortality ratio ( SMR ) on NCD = 1.00 ( 95 % confidence interval ( CI ) 0.84 - 1.34 ) ] . APACHE IV and MPM-III scores presented similar discrimination compared to SAPS 3 on both analyzed days ( P > 0.05 ) . APACHE IV presented satisfactory HL tests over time ( P > 0.100 ) but underestimated mortality [ SMR on DD = 1.92 ( 95 % CI 1.61 - 2.23 ) ; SMR on NCD = 1.46 ( 95 % CI 1.48 - 1.96 ) ] . MPM-III showed unsatisfactory HL test results ( P = 0.027 on DD ; P = 0.045 on NCD ) and underestimated mortality [ SMR on NCD = 2.09 ( 95 % CI 1.48 - 1.96 ) ] . CONCLUSIONS SAPS 3 , especially the geographical customized equation , presented good discrimination and calibration performances , accurately predicting mortality in this group of AKI critically ill patients BACKGROUND The Simplified Acute Physiology Score ( SAPS ) 3 has recently been developed , but not yet vali date d in surgical intensive care unit ( ICU ) patients . We compared the performance of SAPS 3 with SAPS II and the Acute Physiology and Chronic Health Evaluation ( APACHE ) II score in surgical ICU patients . METHODS Prospect ively collected data from all patients admitted to a German university hospital postoperative ICU between August 2004 and December 2005 were analysed . The probability of ICU mortality was calculated for SAPS II , APACHE II , adjusted APACHE II ( adj-APACHE II ) , SAPS 3 , and SAPS 3 customized for Europe [ C-SAPS3 ( Eu ) ] using st and ard formulas . To improve calibration of the prognostic models , a first-level customization was performed , using logistic regression on the original scores , and the corresponding probability of ICU death was calculated for the customized scores ( C-SAPS II , C-SAPS 3 , and C-APACHE II ) . RESULTS The study included 1851 patients . Hospital mortality was 9 % . Hosmer and Lemeshow statistics showed poor calibration for SAPS II , APACHE II , adj-APACHE II , SAPS 3 , and C-SAPS 3 ( Eu ) , but good calibration for C-SAPS II , C-APACHE II , and C-SAPS 3 . Discrimination was generally good for all models [ area under the receiver operating characteristic curve ranged from 0.78 ( C-APACHE II ) to 0.89 ( C-SAPS 3 ) ] . The C-SAPS 3 score appeared to have the best calibration curve on visual inspection . CONCLUSIONS In this group of surgical ICU patients , the performance of SAPS 3 was similar to that of APACHE II and SAPS II . Customization improved the calibration of all prognostic models Objective To evaluate the SAPS 3 score predictive ability of hospital mortality in a large external validation cohort . Design Prospect i ve observational study . Setting and patients A total of 28,357 patients from 147 Italian ICUs joining the Project Margherita national data base of the Gruppo italiano per la Valutazione degli interventi in Terapia Intensiva ( GiViTI ) . Interventions None . MeasurementEvaluation of discrimination through ROC analysis and of overall goodness-of-fit through the Cox calibration test . Main results Although discrimination was good , calibration turned out to be poor . The general and the South-Europe Mediterranean countries equations overestimated hospital mortality overall ( SMR values 0.73 with 95 % CI 0.72–0.75 for both equations ) and homogeneously across risk classes . Overprediction was confirmed among important subgroups , with SMR values ranging between 0.47 and 0.82 . Con \n Output:\n " }, { "from": "agent", "value": "Conclusions Statistically significant departure from perfect calibration for the SAPS 3 general equation was common in validation studies and was correlated with larger studies , as should be expected , since H-L statistics ( both C and H ) are strongly dependent on sample size This finding was also present when major geographic customized equations were evaluated .\nLocal customizations , on the other h and , improved SAPS 3 calibration .\nDiscrimination was almost always very good or excellent , which gives excellent perspectives for local customization when a precise local estimate is needed" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Reduction in hippocampal volume is a hallmark of schizophrenia and already present in the clinical high-risk state . Nevertheless , other subcortical structures , such as the thalamus , amygdala and pallidum can differentiate schizophrenia patients from controls . We studied the role of hippocampal and subcortical structures in clinical high-risk individuals from two cohorts . High-resolution T1-weighted structural MRI brain scans of a total of 91 clinical high-risk individuals and 64 healthy controls were collected in two centers . The bilateral volume of the hippocampus , the thalamus , the cau date , the putamen , the pallidum , the amygdala , and the accumbens were automatically segmented using FSL-FIRST . A linear mixed-effects model and a prospect i ve meta- analysis were applied to assess group-related volumetric differences . We report reduced hippocampal and thalamic volumes in clinical high-risk individuals compared to healthy controls . No volumetric alterations were detected for the cau date , the putamen , the pallidum , the amygdala , or the accumbens . Moreover , we found comparable medium effect sizes for group-related comparison of the thalamus in the two analytical methods . These findings underline the relevance of specific alterations in the hippocampal and subcortical volumes in the high-risk state . Further analyses may allow hippocampal and thalamic volumes to be used as biomarkers to predict psychosis Studies with proton magnetic resonance spectroscopy ( MRS ) have reported abnormalities in N-acetyl-aspartate ( NAA ) , amino acids ( AA ) and choline ( Cho ) to creatine ( Cr ) ratios associated with schizophrenia . We report data on the three ratios in a sample of 18 neuroleptic naive patients with first-episode schizophrenia ( eight studied in the dorsolateral prefrontal and 10 in the midtemporal lobe ) and 24 healthy controls ( 14 studied in prefrontal and 10 in midtemporal lobes ) . Frontal lobe proton spectra were acquired with the stimulated-echo acquisition mode ( STEAM ) pulse sequence ( echo time 21 ms , repetition time 2 s ) . Temporal lobe proton spectra were acquired with the point-resolved spectroscopy ( PRESS ) pulse sequence ( echo time 16–21 ms , repetition time 2 s ) . Upon comparison with normal controls , NAA/Cr ratios were reduced in patients both for the frontal and the temporal lobe . By contrast , Cho/Cr ratios were slightly elevated in frontal and reduced in temporal lobes ; whereas , AA/Cr ratios were normal in frontal and markedly increased in the temporal lobe . The reduced NAA/Cr ratios suggest lower neuronal viability in patients and is consistent with findings of reduced brain volume in both frontal and temporal regions IMPORTANCE Increased glutamate levels in the right associative striatum have been described in patients during a first episode of psychosis . Whether this increase would persist after effective antipsychotic treatment is unknown . OBJECTIVES To compare the glutamate levels in antipsychotic-naive patients with first-episode psychosis in the right associative striatum and right cerebellar cortex using proton magnetic resonance spectroscopy before and 4 weeks after antipsychotic treatment and to compare these results with normative data from sex-matched healthy control subjects . DESIGN , SETTING , AND PARTICIPANTS Before-after trial in an inpatient psychiatric research unit among 24 antipsychotic-naive patients with first-episode psychosis and 18 healthy controls matched for age , sex , h and edness , and cigarette smoking . INTERVENTIONS Participants underwent 2 proton magnetic resonance spectroscopy studies : patients were imaged at baseline and after 4 weeks of antipsychotic treatment , while controls were imaged at baseline and at 4 weeks after the baseline measurement . Patients were treated with oral risperidone ( open label ) for 4 weeks with dosages that were titrated on the basis of clinical judgment . MAIN OUTCOMES AND MEASURES Glutamate levels were estimated using LCModel ( version 6.2 - 1 T ) and were corrected for the cerebrospinal fluid proportion within the voxel . RESULTS Patients with first-episode psychosis had higher levels of glutamate in the associative striatum and the cerebellum during the antipsychotic-naive condition compared with controls . After clinical ly effective antipsychotic treatment , glutamate levels significantly decreased in the associative striatum , with no significant change in the cerebellum . No differences in glutamate levels were observed between groups at 4 weeks . CONCLUSIONS AND RELEVANCE Increased glutamate levels observed at baseline in patients with first-episode psychosis normalized after 4 weeks of clinical ly effective antipsychotic treatment . These results provide support for the hypothesis that improvement in clinical symptoms might be related to a decrease in glutamate levels OBJECTIVES To develop and vali date a new risk-of-bias tool for nonr and omized studies ( NRSs ) . STUDY DESIGN AND SETTING We developed the Risk of Bias Assessment Tool for Nonr and omized Studies ( RoBANS ) . A validation process with 39 NRSs examined the reliability ( interrater agreement ) , validity ( the degree of correlation between the overall assessment s of RoBANS and Method ological Index for Nonr and omized Studies [ MINORS ] , obtained by plotting the overall risk of bias relative to effect size and funding source ) , face validity with eight experts , and completion time for the RoBANS approach . RESULTS RoBANS contains six domains : the selection of participants , confounding variables , the measurement of exposure , the blinding of the outcome assessment s , incomplete outcome data , and selective outcome reporting . The interrater agreement of the RoBANS tool except the measurement of exposure and selective outcome reporting domains ranged from fair to substantial . There was a moderate correlation between the overall risks of bias determined using RoBANS and MINORS . The observed differences in effect sizes and funding sources among the assessed studies were not correlated with the overall risk of bias in these studies . The mean time required to complete RoBANS was approximately 10 min . The external experts who were interviewed evaluated RoBANS as a \" fair \" assessment tool . CONCLUSIONS RoBANS shows moderate reliability , promising feasibility , and validity . The further refinement of this tool and larger validation studies are required \n Output:\n " }, { "from": "agent", "value": "Conclusions : Our findings suggest that impaired neuronal integrity in the thalamus may be a potential trait maker in the early stages of schizophrenia .\nThis study replicated the finding of lower NAA levels in the Thalamus .\nImpaired thalamic neuronal integrity may be a trait maker in early schizophrenia" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Summary Bone pain and spinal axial deformity are major concerns in aged patients suffering from osteoporotic vertebral compression fracture ( VCF ) . Pain can be relieved by vertebroplasty or kyphoplasty procedures , in which the compressed vertebral body is filled with substitutes . We r and omly assigned 100 patients with osteoporotic compression fracture at the thoraco-lumbar ( T-L ) junction into two groups : vertebroplasty and kyphoplasty ; we used polymethylmethacrylate ( PMMA ) as the bone filler . Pain before and after treatment was assessed with visual analog scale ( VAS ) scores and vertebral body height and kyphotic wedge angle were measured from reconstructed computed tomography images . More PMMA was used in the kyphoplasty group than in the vertebroplasty group ( 5.56 ± 0.62 vs. 4.91 ± 0.65 mL , p < 0.001 ) . Vertebral body height and kyphotic wedge angle of the T-L spine were also improved ( p < 0.001 ) . VAS pain scores did not differ significantly between the treatment groups . The duration of follow-up was 6 months . Two patients in the kyphoplasty group had an adjacent segment fracture . In terms of clinical outcome there was little difference between the treatment groups . Thus , owing to the higher cost of the kyphotic balloon procedure , we recommend vertebroplasty over kyphoplasty for the treatment of osteoporotic VCFs . Introduction Spinal axial deformities are major concerns in aged patients suffering from osteoporotic vertebral compression fracture . Pain may be relieved by vertebroplasty or kyphoplasty . We investigated the radiological and clinical outcomes of these procedures . Methods One hundred cases of VCF at the thoraco-lumbar junction were r and omly assigned into two groups : vertebroplasty or kyphoplasty ( 50 cases each ) . We used polymethylmethacrylate as the bone filler . Pain before and after treatment was assessed with visual analog scale scores and vertebral body height and kyphotic wedge angle were measured from reconstructed computed tomography images . Results More PMMA was used in the kyphoplasty group than in the vertebroplasty group ( 5.56 ± 0.62 vs. 4.91 ± 0.65 mL , p < 0.001 ) . Vertebral body height and kyphotic wedge angle of the T-L spine were also improved ( p < 0.001 ) . VAS pain scores did not differ significantly between the treatment groups . The duration of follow-up was 6 months . Two patients in the kyphoplasty group had an adjacent segment fracture . Conclusions In terms of clinical outcome there was little difference between the treatment groups . Thus , with the higher cost of the kyphotic balloon procedure , we recommend vertebroplasty over kyphoplasty for the treatment of osteoporotic VCFs Abstract : The purpose of this r and omized , double-masked , placebo-controlled study was to determine the efficacy and safety of risedronate in the prevention of vertebral fractures in postmenopausal women with established osteoporosis . The study was conducted at 80 study centers in Europe and Australia . Postmenopausal women ( n= 1226 ) with two or more prevalent vertebral fractures received risedronate 2.5 or 5 mg/day or placebo ; all subjects also received elemental calcium 1000 mg/day , and up to 500 IU/day vitamin D if baseline levels were low . The study duration was 3 years ; however , the 2.5 mg group was discontinued by protocol amendment after 2 years . Lateral spinal radiographs were taken annually for assessment of vertebral fractures , and bone mineral density was measured by dual-energy X-ray absorptiometry at 6-month intervals . Risedronate 5 mg reduced the risk of new vertebral fractures by 49 % over 3 years compared with control ( p<0.001 ) . A significant reduction of 61 % was seen within the first year ( p= 0.001 ) . The fracture reduction with risedronate 2.5 mg was similar to that in the 5 mg group over 2 years . The risk of nonvertebral fractures was reduced by 33 % compared with control over 3 years ( p= 0.06 ) . Risedronate significantly increased bone mineral density at the spine and hip within 6 months . The adverse-event profile of risedronate , including gastrointestinal adverse events , was similar to that of control . Risedronate 5 mg provides effective and well-tolerated therapy for severe postmenopausal osteoporosis , reducing the incidence of vertebral fractures and improving bone density in women with established disease UNLABELLED Oral daily ( 2.5 mg ) and intermittent ib and ronate ( between-dose interval of > 2 months ) , delivering a similar cumulative exposure , were evaluated in 2946 osteoporotic women with prevalent vertebral fracture . Significant reduction in incident vertebral fracture risk by 62 % and 50 % , respectively , was shown after 3 years . This is the first study to prospect ively show antifracture efficacy for the intermittent administration of a bisphosphonate . INTRODUCTION Bisphosphonates are important therapeutics in postmenopausal osteoporosis . However , they are currently associated with stringent dosing instructions that may impair patient compliance and hence therapeutic efficacy . Less frequent , intermittent administration may help to overcome these deficiencies . This study assessed the efficacy and safety of oral ib and ronate administered either daily or intermittently with a dose-free interval of > 2 months . MATERIAL S AND METHODS This r and omized , double-blind , placebo-controlled , parallel-group study enrolled 2946 postmenopausal women with a BMD T score < or = -2.0 at the lumbar spine in at least one vertebra ( L1-L4 ) and one to four prevalent vertebral fractures ( T4-L4 ) . Patients received placebo or oral ib and ronate administered either daily ( 2.5 mg ) or intermittently ( 20 mg every other day for 12 doses every 3 months ) . RESULTS AND CONCLUSIONS After 3 years , the rate of new vertebral fractures was significantly reduced in patients receiving oral daily ( 4.7 % ) and intermittent ib and ronate ( 4.9 % ) , relative to placebo ( 9.6 % ) . Thus , daily and intermittent oral ib and ronate significantly reduced the risk of new morphometric vertebral fractures by 62 % ( p = 0.0001 ) and 50 % ( p = 0.0006 ) , respectively , versus placebo . Both treatment groups also produced a statistically significant relative risk reduction in clinical vertebral fractures ( 49 % and 48 % for daily and intermittent ib and ronate , respectively ) . Significant and progressive increases in lumbar spine ( 6.5 % , 5.7 % , and 1.3 % for daily ib and ronate , intermittent ib and ronate , and placebo , respectively , at 3 years ) and hip BMD , normalization of bone turnover , and significantly less height loss than in the placebo group were also observed for both ib and ronate regimens . The overall population was at low risk for osteoporotic fractures . Consequently , the incidence of nonvertebral fractures was similar between the ib and ronate and placebo groups after 3 years ( 9.1 % , 8.9 % , and 8.2 % in the daily , intermittent , and placebo groups , respectively ; difference between arms not significant ) . However , findings from a posthoc analysis showed that the daily regimen reduces the risk of nonvertebral fractures ( 69 % ; p = 0.012 ) in a higher-risk subgroup ( femoral neck BMD T score < -3.0 ) . In addition , oral ib and ronate was well tolerated . Oral ib and ronate , whether administered daily or intermittently with an extended between-dose interval of > 2 months , is highly effective in reducing the incidence of osteoporotic fractures in postmenopausal women . This is the first time that significant fracture efficacy has been prospect ively shown with an intermittently administered bisphosphonate in the overall study population of a r and omized , controlled clinical trial . Thus , oral ib and ronate holds promise as an effective and convenient alternative to current bisphosphonate therapies We report a prospect i ve , r and omized , multicenter , open-label 2-year trial of 81 postmenopausal women aged 53 - 79 years with at least one minimal-trauma vertebral fracture ( VF ) and low ( T-score below - 2 ) lumbar bone mineral density ( BMD ) . Group HRT received piperazine estrone sulfate ( PES ) 0.625 – 1.25 mg/d ± medroxyprogesterone acetate ( MPA ) 2.5 – 5 mg/d ; group HRT/D received HRT plus calcitriol 0.25 µg bd . All with a baseline dietary calcium ( Ca ) of < 1 g/d received Ca carbonate 0.6 g nocte . Final data were on 66 – 70 patients . On HRT/D , significant ( P < 0.001 ) BMD increases from baseline by DXA were at total body – head , trochanter , Ward ’s , total hip , intertrochanter and femoral shaft ( % group mean Δ 4.2 , 6.1 , 9.3 , 3.7 , 3.3 and 3.3 % , respectively ) . On HRT , at these 6 sites , significant Δs were restricted to the trochanter and Wards . Significant advantages of HRT/D over HRT were in BMD of total body ( - head ) , total hip and trochanter ( all P= 0.01 ) . The differences in mean Δ at these sites were 1.3 , 2.6 and 3.9 % . At the following , both groups improved significantly -lumbar spine ( AP and lateral ) , forearm shaft and ultradistal tibia/fibula . The weightbearing , site — specific benefits of the combination associated with significant suppression of parathyroid hormone — suggest a beneficial effect on cortical bone . Suppression of bone turnover was significantly greater on HRT/D ( serum osteocalcin P= 0.024 and urinary hydroxyproline/creatinine ratio P= 0.035 ) . There was no significant difference in the number of patients who developed fresh VFs during the trial ( HRT 8/36 , 22 % ; HRT/D 4/34 , 12 % - intention to treat ) ; likewise in the number who developed incident nonvertebral fractures . This is the first study comparing the 2 treatments in a fracture population . The results indicate a significant benefit of calcitriol combined with HRT on total body BMD and on BMD at the hip , the major site of osteoporotic fracture BACKGROUND Osteoporotic structural damage and bone fragility result from reduced bone formation and increased bone resorption . In a phase 2 clinical trial , strontium ranelate , an orally active drug that dissociates bone remodeling by increasing bone formation and decreasing bone resorption , has been shown to reduce the risk of vertebral fractures and to increase bone mineral density . METHODS To evaluate the efficacy of strontium ranelate in preventing vertebral fractures in a phase 3 trial , we r and omly assigned 1649 postmenopausal women with osteoporosis ( low bone mineral density ) and at least one vertebral fracture to receive 2 g of oral strontium ranelate per day or placebo for three years . We gave calcium and vitamin D supplements to both groups before and during the study . Vertebral radiographs were obtained annually , and measurements of bone mineral density were performed every six months . RESULTS New vertebral fractures occurred in fewer patients in the strontium ranelate group than in the placebo group , with a risk reduction of 49 percent in the first year of treatment and 41 percent during the three-year study period ( relative risk , 0.59 ; 95 percent confidence interval , 0.48 to 0.73 ) . Strontium ranelate increased bone mineral density at month 36 by 14.4 percent at the lumbar spine and 8.3 percent at the femoral neck ( P<0.001 for both comparisons ) . There were no significant differences between the groups in the incidence of serious adverse events . CONCLUSIONS Treatment of postmenopausal osteoporosis with strontium ranelate leads to early and sustained reductions in the risk of vertebral fractures Raloxifene is a selective estrogen receptor modulator that in experimental animals acts as an estrogen receptor antagonist in breast and endometrium but as an estrogen receptor agonist in the skeletal and cardiovascular systems . We conducted a 1-year prospect i ve , r and omized , double-blind trial in 143 postmenopausal osteoporotic women ( mean + /- SD age , 68.4+/-5.0 years ) with at least one prevalent vertebral fractures and low bone mineral density ( BMD ) , comparing groups receiving raloxifene at 60 mg/day ( RLX \n Output:\n " }, { "from": "agent", "value": "The weak recommendations address the use of ib and ronate and strontium ranelate to prevent additional symptomatic fractures , the use of L2 nerve root blocks to treat the pain associated with L3 or L4 fractures , and the use of kyphoplasty to treat symptomatic fractures in patients who are neurologically intact" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: A multicenter retrospective audit of carotid endarterectomies performed during 1981 was completed with 46 institutions contributing 3,328 cases . Overall , there was a 2.5 % risk of transient neurological dysfunction following surgery and a 6 % risk of stroke or death . The intra-institutional combined major morbidity and mortality varied from 21 % to 0 . Those institutions with greater than 700 beds had a statistically lower incidence of stroke or death than did other institutions . The incidence of stroke or death postoperatively was significantly lower for patients who were operated on for amaurosis fugax or for unspecified reasons . Those patients who were operated on for a progressing stroke had a higher incidence of stroke but this group was at greatest risk for stroke without surgery . The incidence of postoperative stroke or death was related to the type of arterial repair ; vein patch grafting was statistically better than both fabric patch grafting and primary closure . When all patients who were not monitored during surgery were compared to all patients who had electroencephalographic ( EEG ) monitoring , there was found to be a significant statistical difference in favor of the EEG group . Endarterectomy combined with coronary artery bypass or simultaneous bilateral endarterectomies had a statistically significant higher incidence of stroke or death than did unilateral carotid endarterectomy OBJECTIVE To compare the extent of subtle cerebral damage ( SCD ) in patients undergoing carotid endarterectomy with or without shunt placement . DESIGN Prospect i ve , r and omised study . PATIENTS AND METHODS We assessed a consecutive series of 96 patients undergoing endarterectomy for severe unilateral left carotid stenosis who had been r and omly assigned to receive a shunt ( 48 ) or not ( 48 ) . Eligibility criteria included age up to 80 years and Mini-Mental State Examination score > 24 points . Patients underwent neuropsychological testing before surgery . Serum concentrations of S100 protein , neuron-specific enolase ( NSE ) and interleukin-6 ( IL-6 ) were measured intraoperatively before and after carotid clamping . Finally , each patient underwent neuropsychological testing 3 weeks after surgery . RESULTS Patients with and without shunt had similar serum concentrations of S100 protein , NSE and IL-6 as well as similar neuropsychological test scores , all p>0.05 . CONCLUSIONS There was no difference in subtle cerebral damage between patients r and omized to receive a shunt or not A prospect i ve study was undertaken to determine the efficacy of performing carotid endarterectomy without an intraluminal shunt . During a two-year period , 240 patients , ranging in age from 36 to 89 years , underwent 309 consecutive carotid endarterectomies . The indication for operation was transient ischemic attacks in 151 ( 63 % ) patients , asymptomatic carotid bruit in 67 ( 28 % ) , and previous stroke in 22 ( 9 % ) . Internal shunts were not used in any patients and all arteriotomies were patched with a preclotted knitted Dacron@ velor patch . Systemic heparinization was used during the procedure . The early postoperative mortality was 0.64 % ( 2/309 ) . Both deaths were caused by myocardial infa rct ion . The incidence of stroke after operation was 1.29 % ( 4/309 ) . Neither carotid clamp time nor the presence of contralateral disease correlated with the occurrence of postoperative stroke . According to results of angiography , 22 patients had total occlusion of the contralateral internal carotid artery with satisfactory intracranial circulation . No postoperative strokes occurred in this subgroup . Results of this study revealed that equally good or superior results may be obtained without a temporary shunt in performing carotid endarterectomy Because of controversies in the cerebrovascular literature regarding the use of an intraluminal shunt in carotid endarterectomy , we report a r and omized prospect i ve study of 118 consecutive symptomatic patients receiving surgery within a single neurosurgical practice . Over 4 years , 138 carotid endarterectomies were performed in the 118 patients , 63 operations with intraluminal shunting and 75 without . St and ard rationale for surgery included ipsilateral cerebral infa rct ion in 38 % of the operations and ipsilateral transient ischemic attacks in 36 % . Unilateral angiographic stenosis of greater than 90 % was seen in 58 % of the operations ; there were no ipsilateral occlusions . Surgery was performed under general anesthesia with barbiturate induction and mild blood pressure elevation . The 30-day complication rate included a mortality rate of 0.7 % with a 5.1 % incidence of postoperative neurologic deficit and a 1.4 % rate of myocardial infa rct ion . In the 24 hours after surgery there were no cerebral infa rct ions in the shunted group and six in the unshunted group . This 8 % rate in the unshunted group compared with 0 % in the shunted group was significant at p = 0.023 with a power of 0.95 by Fisher 's exact test and chi 2 analysis . This suggests that in our neurosurgical practice ( resident training program ) the use of an intraluminal shunt during carotid endarterectomy significantly reduces the risk of intraoperative neurologic deficit without increasing the incidence of other complications One hundred and thirty-one patients undergoing 142 carotid endarterectomy procedures were r and omized to have their operation performed either with or without intra-operative electroencephalographic ( EEG ) monitoring . Patients with EEG monitoring were shunted if both the internal carotid back pressure ( ICBP ) was less than 50 mmHg and ipsilateral change was evident on the EEG after clamping . Patients without EEG monitoring were shunted if ICBP was less than 50 mmHg . There one postoperative death ( 0.7 % ) with neurological deficits occurring in five patients ( 3.5 % ) . There were significantly fewer neurological deficits ( P = 0.02 ) in patients with no EEG change ( one of 59 ) compared with those with EEG change ( two of 13 ) . There was a highly significant increase ( P = 0.005 ) in incidence of neurological deficit ( two of five patients ) when ICBP was considered ' adequate ' at 50 mmHg or greater but EEG change occurred . No neurological deficit occurred in 14 patients who were not shunted with ICBP less than 50 mmHg but with no EEG change . There was no difference in the incidence of neurological deficit in patients with low and high ICBP when both 50 and 55 mmHg were used as the cut-off points . It is concluded that EEG monitoring is useful in identifying patients requiring shunting during carotid endarterectomy . Use of a shunt is recommended if there is EEG change regardless of ICBP ; conversely , if ICBP is low but there is no EEG change it would appear safe to proceed without shunting BACKGROUND Among patients with substantial carotid artery narrowing but no recent neurological symptom ( stroke or transient ischaemia ) , the balance of surgical risks and long-term benefits from carotid endarterectomy ( CEA ) was unclear . METHODS During 1993 - 2003 , 3120 asymptomatic patients with substantial carotid narrowing were r and omised equally between immediate CEA ( half got CEA by 1 month , 88 % by 1 year ) and indefinite deferral of any CEA ( only 4 % per year got CEA ) and were followed for up to 5 years ( mean 3.4 years ) . Kaplan-Meier analyses of 5-year risks are by allocated treatment . FINDINGS The risk of stroke or death within 30 days of CEA was 3.1 % ( 95 % CI 2.3 - 4.1 ) . Comparing all patients allocated immediate CEA versus all allocated deferral , but excluding such perioperative events , the 5-year stroke risks were 3.8 % versus 11 % ( gain 7.2 % [ 95 % CI 5.0 - 9.4 ] , p<0.0001 ) . This gain chiefly involved carotid territory ischaemic strokes ( 2.7 % vs 9.5 % ; gain 6.8 % [ 4.8 - 8.8 ] , p<0.0001 ) , of which half were disabling or fatal ( 1.6 % vs 5.3 % ; gain 3.7 % [ 2.1 - 5.2 ] , p<0.0001 ) , as were half the perioperative strokes . Combining the perioperative events and the non-perioperative strokes , net 5-year risks were 6.4 % versus 11.8 % for all strokes ( net gain 5.4 % [ 3.0 - 7.8 ] , p<0.0001 ) , 3.5 % versus 6.1 % for fatal or disabling strokes ( net gain 2.5 % [ 0.8 - 4.3 ] , p=0.004 ) , and 2.1 % versus 4.2 % just for fatal strokes ( net gain 2.1 % [ 0.6 - 3.6 ] , p=0.006 ) . Subgroup-specific analyses found no significant heterogeneity in the perioperative hazards or ( apart from the importance of cholesterol ) in the long-term postoperative benefits . These benefits were separately significant for males and females ; for those with about 70 % , 80 % , and 90 % carotid artery narrowing on ultrasound ; and for those younger than 65 and 65 - 74 years of age ( though not for older patients , half of whom die within 5 years from unrelated causes ) . Full compliance with allocation to immediate CEA or deferral would , in expectation , have produced slightly bigger differences in the numbers operated on , and hence in the net 5-year benefits . The 10-year benefits are not yet known . INTERPRETATION In asymptomatic patients younger than 75 years of age with carotid diameter reduction about 70 % or more on ultrasound ( many of whom were on aspirin , antihypertensive , and , in recent years , statin therapy ) , immediate CEA halved the net 5-year stroke risk from about 12 % to about 6 % ( including the 3 % perioperative hazard ) . Half this 5-year benefit involved disabling or fatal strokes . But , outside trials , inappropriate selection of patients or poor surgery could obviate such benefits OBJECTIVES To investigate the in vivo haemodynamic performance and neurological outcome of two types of carotid shunt . DESIGN R and omised single surgeon study of consecutive symptomatic patients . SETTING 163 consecutive patients undergoing carotid endarterectomy for symptomatic carotid disease were r and omised to the Javid or Pruitt shunt . CHIEF OUTCOME MEASURES Middle cerebral artery velocity ( MCAV ) , preoperatively , during clamping , during shunting and post-restoration of flow , embolic episodes , neurological outcome . MAIN RESULTS The MCAV preoperatively , at carotid clamping , and postoperatively was the same for both groups ( p > 0.15 ) . During shunting the MCAV was significantly lower in the Pruitt group , p < 0.005 , 59 % of the Javid and 34 % of the Pruitt shunts maintained MCAV at preoperative levels p < 0.005 , chi 2 = 8.92 . The Javid shunt produced significantly more emboli ( 73 % of cases ) at declamping than the Pruitt ( 41 % ) , p < 0.0002 , chi 2 = 14.7 . Four Javid patients and one Pruitt had disabling thromboembolic strokes ; overall thromboembolic stroke rate 3.7 % . The difference in stroke rates was not statistically significant ( p = 0.14 ) . CONCLUSIONS The Pruitt shunt was unable to maintain preoperative MCAV in 66 % of cases , the Javid shunt had a higher incidence of emboli on declamping . These factors may lead to an increased risk of stroke ; however , the numbers required for statistical confirmation would be large BACKGROUND Without strong evidence of benefit , the use of carotid endarterectomy for prophylaxis against stroke rose dramatically until the mid-1980s , then declined . Our investigation sought to determine whether carotid endarterectomy reduces the risk of stroke among patients with a recent adverse cerebrovascular event and ipsilateral carotid stenosis . METHODS We conducted a r and omized trial at 50 clinical centers throughout the United States and Canada , in patients in two predetermined strata based on the severity of carotid stenosis--30 to 69 percent and 70 to 99 percent . We report here the results in the 659 patients in the latter stratum , who had had a hemispheric or retinal transient ischemic attack or a nondisabling stroke within the 120 days before entry and had stenosis of 70 to 99 percent in the symptomatic carotid artery . All patients received optimal medical care , including antiplatelet therapy . Those assigned to surgical treatment underwent carotid endarterectomy performed by neurosurgeons or vascular surgeons . All patients were examined by neurologists 1 , 3 , 6 , 9 , and 12 months after entry and then \n Output:\n " }, { "from": "agent", "value": "No significant difference was found between the groups in terms of postoperative neurological deficit between selective shunting with and without near-infrared refractory spectroscopy monitoring , However , this analysis was inadequately powered to reliably detect the effect .\nThere was no significant difference between the risk of ipsilateral stroke in participants selected for shunting with the combination of electroencephalographic and carotid pressure assessment compared with pressure assessment alone , although again the data were limited .\nNo method of monitoring in selective shunting has been shown to produce better outcomes" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Abstract The relationship of the degree of use of each of ten types of illicit drugs with each of eight types of violent criminal offenses , is reported for an African-American , inner-city , low SES , young adult study sample ( N = 612 ) . Prospect i ve data from the time of birth was available for the statistical analyses , to provide 51 control variables on factors other than substance use which might predict to later violent behavior . Findings : Greater frequency of use of marijuana was found unexpectedly to be associated with greater likelihood to commit weapons offenses ; and this association was not found for any of the other drugs , except for alcohol . Marijuana use was also found associated with commission of Attempted Homicide/Reckless Endangerment offenses . Cocaine/crack and marijuana were the only two types of drugs the frequency of use of which was found , for this sample , to be significantly related to the frequency of being involved in the selling of drugs . These findings may not apply to a middle-class African-American sample Long-term cocaine and alcohol use is associated with neuropsychological impairments that implicate poor inhibitory mechanisms of behavioural control . This study tested acquisition and discrimination-reversal learning in a group of polydrug users ( n 20 ) with a history of cocaine and heavy alcohol use and a group of age-matched controls ( n 20 ) . A cued go/nogo task measured subjects ’ ability to learn stimulus-response associations that involved the quick activation and sudden inhibition of responses . Compared with controls , drug users displayed similar acquisition , but impaired discrimination-reversal learning of both inhibitory and activational responses . The results suggest that some drug-related neuropsychological deficits might reflect specific impairments of the ability to inhibit interference from prior learning . The findings contribute to growing evidence that suggests cocaine and alcohol use could produce broad inhibitory impairments that increase the risk for learning deficits and poor impulse control Deficits in cognitive control are implicated in cocaine dependence . Previously , combining functional magnetic resonance imaging and a stop signal task , we demonstrated altered cognitive control in cocaine-dependent individuals . However , the clinical implication s of these cross-sectional findings and , in particular , whether the changes were associated with relapse to drug use , were not clear . In a prospect i ve study , we recruited 97 treatment-seeking individuals with cocaine dependence to perform the stop signal task during functional magnetic resonance imaging and participate in follow-up assessment s for 3 months , during which time cocaine use was evaluated with timeline follow back and ascertained by urine toxicology tests . Functional magnetic resonance imaging data were analysed using general linear models as implemented in Statistical Parametric Mapping 8 , with the contrast ' stop error greater than stop success trials ' to index error processing . Using voxelwise analysis with logistic and Cox regressions , we identified brain activations of error processing that predict relapse and time to relapse . In females , decreased error-related activations of the thalamus and dorsal anterior cingulate cortex predicted relapse and an earlier time to relapse . In males , decreased error-related activations of the dorsal anterior cingulate cortex and left insula predicted relapse and an earlier time to relapse . These regional activations were vali date d with data resampling and predicted relapse with an average area under the curve of 0.849 in receiver operating characteristic analyses . These findings provide direct evidence linking deficits in cognitive control to clinical outcome in a moderate-sized cohort of cocaine-dependent individuals . These results may provide a useful basis for future studies to examine how psychosocial factors interact with cognitive control to determine drug use and to evaluate the efficacy of pharmacological or behavioural treatment in remediating deficits of cognitive control in cocaine addicts Chronic and recreational use of cocaine has been shown to impair inhibitory output control ( response inhibition ) but whether input control is also affected is an open question . For the first time , this study compared the ability to perform a cued target-discrimination task that measured inhibition of return ( IOR ) , a reflexive inhibitory mechanism that delays attention from returning to a previously attended location , in adult recreational users and in a cocaine-free-matched sample controlled for age , race , gender distribution , and level of intelligence . Results show that the recreational use of cocaine eliminates IOR , suggesting that input control is strongly impaired Two experiments investigated attentional biases for smoking-related cues in smokers and nonsmokers , using the visual probe task . In Experiment 1 , when pictures were displayed for 500 ms , smokers who had made repeated quit attempts showed an attentional bias for smoking-related scenes . Experiment 2 replicated this finding and revealed that when pictures were presented for 2,000 ms , the smoker group as a whole showed vigilance for smoking-related cues , but nonsmokers did not . The findings from the 500-ms exposure condition suggest that initial orienting of attention to smoking cues was associated with repeated unsuccessful attempts at abstinence in smokers . Results are discussed with reference to incentive-sensitization theories of addiction and to component processes of selective attention , such as initial orienting versus maintenance \n Output:\n " }, { "from": "agent", "value": "In 90 % of the studies review ed the presence of inhibitory control deficits was reported , verified by impaired cognitive processing and response monitoring , as well as high levels of impulsiveness , regardless of the pattern of crack and /or cocaine consumption ( recreational or chronic ) .\nFormer users showed high levels of impulsiveness even after long periods of abstinence .\nCrack and /or cocaine users may have inhibitory control deficits , irrespective of different consumption patterns .\nHigh levels of impulsiveness can represent a factor of vulnerability to drug use and relapse" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background : Nonselective systemic vasodilators worsen ventilation perfusion ( V/Q ) matching and gas exchange in patients with chronic obstructive pulmonary disease ( COPD ) . Inhaled iloprost has the potential to act preferentially in ventilated regions of the lung , thereby reducing pulmonary hypertension ( PH ) while alveolar ventilation is still maintained . Objectives : To investigate the acute effects of inhaled iloprost on V/Q matching in patients with COPD and PH . Methods : Ten males with COPD and PH on echocardiography were evaluated before and after inhaling 2 doses of iloprost ( 2.5 µg ) . Measurements included lung function , arterial blood gas , 6-min walk test ( 6MWT ) as well as ventilatory equivalents for oxygen ( VE/VO2 ) and carbon dioxide ( VE/VCO2 ) taken at baseline , 30 min following each dose of iloprost , and 2 h after the second dose . Results : Mean differences in VE/VCO2 and VE/VO2 were –13.3 ( 95 % CI –36.5 to –2.7 ; p = 0.002 ) and –15.0 ( 95 % CI –36.7 to –0.4 ; p = 0.02 ) , respectively , and the mean change in ( A-a ) gradient was –3.7 mm Hg ( 95 % CI –6.1 to –1.0 ; p = 0.01 ) after a single dose of iloprost , whereas mean improvement in 6MWT was 49.8 m ( 95 % CI 14.8 to 84.7 ; p = 0.02 ) . Arterial blood gas , venous admixture , dead space fraction and lung functions were maintained after iloprost . The effects of iloprost were reproducible after the second dose . All measurements returned to baseline 2 h after the last dose . No adverse effects on systemic blood pressure or oxygen saturation were seen . Conclusions : Iloprost inhalation was safe in patients with COPD and PH , and was associated with improved V/Q matching and exercise tolerance Abstract Rationale : Pulmonary hypertension with exercise is common in chronic obstructive pulmonary disease ( COPD ) and may contribute to exercise limitation in this disease . We aim ed to determine the effects of treatment with sildenafil on exercise capacity in patients with COPD and emphysema . Methods : We performed a r and omized , double-blind , placebo-controlled 2-period crossover trial of sildenafil thrice daily in ten adults with COPD and emphysema on CT scan without pulmonary hypertension . We r and omized study participants to 4 weeks of sildenafil ( or placebo ) followed by a 1-week washout and then 4 weeks of placebo ( or sildenafil ) . The 2 primary outcomes were the 6-minute walk distance and oxygen consumption at peak exercise . Results : Sildenafil had no effect on 6-minute walk distance ( placebo-corrected difference = -7.8 m , 95 % confidence interval , -23.2 to 7.5 m , p = 0.35 ) or oxygen consumption at peak exercise ( placebo-corrected difference = -0.1 ml/kg/min , 95 % confidence interval -2.1 to 1.8 ml/kg/min , p = 0.89 ) . Sildenafil increased the alveolar-arterial oxygen gradient ( p = 0.02 ) , worsened symptoms ( p = 0.04 ) , and decreased quality -of-life ( p = 0.03 ) . Adverse events were more frequent while receiving sildenafil ( p = 0.005 ) . Conclusions : Routine sildenafil administration did not have a beneficial effect on exercise capacity in patients with COPD and emphysema without pulmonary hypertension . Sildenafil significantly worsened gas exchange at rest and quality of life . ( clinical trials.gov NCT00104637 ) BACKGROUND Sildenafil inhibits phosphodiesterase type 5 , an enzyme that metabolizes cyclic guanosine monophosphate , thereby enhancing the cyclic guanosine monophosphate-mediated relaxation and growth inhibition of vascular smooth-muscle cells , including those in the lung . METHODS In this double-blind , placebo-controlled study , we r and omly assigned 278 patients with symptomatic pulmonary arterial hypertension ( either idiopathic or associated with connective-tissue disease or with repaired congenital systemic-to-pulmonary shunts ) to placebo or sildenafil ( 20 , 40 , or 80 mg ) orally three times daily for 12 weeks . The primary end point was the change from baseline to week 12 in the distance walked in six minutes . The change in mean pulmonary-artery pressure and World Health Organization ( WHO ) functional class and the incidence of clinical worsening were also assessed , but the study was not powered to assess mortality . Patients completing the 12-week r and omized study could enter a long-term extension study . RESULTS The distance walked in six minutes increased from baseline in all sildenafil groups ; the mean placebo-corrected treatment effects were 45 m ( + 13.0 percent ) , 46 m ( + 13.3 percent ) , and 50 m ( + 14.7 percent ) for 20 , 40 , and 80 mg of sildenafil , respectively ( P<0.001 for all comparisons ) . All sildenafil doses reduced the mean pulmonary-artery pressure ( P=0.04 , P=0.01 , and P<0.001 , respectively ) , improved the WHO functional class ( P=0.003 , P<0.001 , and P<0.001 , respectively ) , and were associated with side effects such as flushing , dyspepsia , and diarrhea . The incidence of clinical worsening did not differ significantly between the patients treated with sildenafil and those treated with placebo . Among the 222 patients completing one year of treatment with sildenafil monotherapy , the improvement from baseline at one year in the distance walked in six minutes was 51 m. CONCLUSIONS Sildenafil improves exercise capacity , WHO functional class , and hemodynamics in patients with symptomatic pulmonary arterial hypertension BACKGROUND Sildenafil has been found to improve exercise capacity and haemodynamic parameters in patients with various pulmonary disorders . This study was undertaken to evaluate its efficacy in severe chronic obstructive pulmonary disease ( COPD ) . METHODS In this double-blind , r and omised , placebo-controlled study , 37 patients with severe COPD received either sildenafil or placebo for 12 weeks . Distance covered in six-minute walk test ( 6MWD ) was taken as primary end-point . Pulmonary artery pressure ( PAP ) was measured as secondary end point . RESULTS Thirty-three patients ( 15 in sildenafil arm and 18 in placebo arm ) completed the study . Non-parametric tests were used for comparison . There was significant increase in 6MWD from baseline after three months of follow-up in sildenafil users ( median change in distance covered in six-minute walk test ( delta6MWD ) = 190 m ) as compared to placebo users ( delta6MWD = 0 m , p < 0.05 ) . The PAP decreased significantly ( chi2 = 14.94 , p < 0.05 ) in sildenafil group after three months , while it did not change significantly among placebo group ( chi2 = 3.84 , p > 0.05 ) . CONCLUSION Sildenafil improved 6MWD and PAP in patients with severe COPD Pulmonary hypertension is a life-threatening complication of lung fibrosis . Vasodilator therapy is difficult owing to systemic side effects and pulmonary ventilation-perfusion mismatch . We compared the effects of intravenous prostacyclin and inhaled NO and aerosolized prostacyclin in r and omized order and , in addition , tested for effects of oxygen and systemic calcium antagonists ( CAAs ) in eight patients with lung fibrosis and pulmonary hypertension . Aerosolized prostagl and in (PG)I(2 ) caused preferential pulmonary vasodilatation with a decrease in mean pulmonary arterial pressure from 44.1 + /- 4.2 to 31.6 + /- 3.1 mm Hg , and pulmonary vascular resistance ( RL ) from 810 + /- 226 to 386 + /- 69 dyn . s. cm(-)(5 ) ( p < 0.05 , respectively ) . Systemic arterial pressure , arterial oxygen saturation , and pulmonary right-to-left shunt flow , measured by multiple inert gas analysis , were not significantly changed . Inhaled NO similarly result ed in selective pulmonary vasodilatation , with RL decreasing from 726 + /- 217 to 458 + /- 81 dyn . s. cm(-)(5 ) . In contrast , both intravenous PGI(2 ) and CAAs were not pulmonary selective , result ing in a significant drop in arterial pressure . In addition , PGI(2 ) infusion caused a marked increase in shunt flow . Long-term therapy with aerosolized iloprost ( long-acting PGI(2 ) analog ) result ed in unequivocal clinical improvement from a state of immobilization and severe resting dyspnea in a patient with decompensated right heart failure . We concluded that , in pulmonary hypertension secondary to lung fibrosis , aerosolization of PGI(2 ) or iloprost causes marked pulmonary vasodilatation with maintenance of gas exchange and systemic arterial pressure . Long-term therapy with inhaled iloprost may be life saving in decompensated right heart failure from pulmonary hypertension secondary to lung fibrosis Pulmonary hypertension is a serious complication of chronic obstructive pulmonary disease ( COPD ) that currently has no established pharmacological treatment . This study aim ed to assess whether concomitant treatment with sildenafil would enhance the results of pulmonary rehabilitation in patients with COPD and increased pulmonary arterial pressure ( PAP ) . In this double-blind , r and omised controlled trial patients received 20 mg sildenafil or placebo three times daily and underwent pulmonary rehabilitation for 3 months . The primary end-point was the gain in the cycle endurance time at a constant work-rate . Secondary end-points included performance in the incremental exercise test , 6-min walk distance and quality of life . 63 patients with severe COPD and moderately increased PAP were r and omised . Cycle endurance time increased by 149 s ( 95 % CI 26–518 s ) in the sildenafil group and by 169 s ( 95 % CI 0–768 s ) in the placebo group ( median change difference -7 s , 95 % CI -540–244 s ; p=0.77 ) . Gains in the incremental exercise test , 6-min walk distance and quality of life at the end of the study did not differ between groups . Measurements of arterial oxygenation and adverse events were similar in both groups . In patients with severe COPD and moderately increased PAP , concomitant treatment with sildenafil does not improve the results of pulmonary rehabilitation in exercise tolerance . Sildenafil did not improve respiratory rehabilitation outcomes in patients with severe COPD and moderately increased PAP Pulmonary hypertension during exercise is common in severe chronic obstructive pulmonary disease ( COPD ) . It was hypothesised that the use of the endothelin-receptor antagonist bosentan can improve cardiopulmonary haemodynamics during exercise , thus increasing exercise tolerance in patients with severe COPD . In the present double-blind , placebo-controlled study , 30 patients with severe or very severe COPD were r and omly assigned in a 2:1 ratio to receive either bosentan or placebo for 12 weeks . The primary end-point was change in the 6-min walking distance . Secondary end-points included changes in health-related quality of life , lung function , cardiac haemodynamics , maximal oxygen uptake and pulmonary perfusion patterns . Compared with placebo , patients treated with bosentan during 12 weeks showed no significant improvement in exercise capacity as measured by the 6-min walking distance ( mean±sd 331±123 versus 329±94 m ) . There was no change in lung function , pulmonary arterial pressure , maximal oxygen uptake or regional pulmonary perfusion pattern . In contrast , arterial oxygen pressure dropped , the alveolar – arterial gradient increased and quality of life deteriorated significantly in patients assigned bosentan . The oral administration of the endothelin receptor antagonist bosentan not only failed to improve exercise capacity but also deteriorated hypoxaemia and functional status in severe chronic obstructive pulmonary disease patients without severe pulmonary hypertension at rest RATIONALE Sildenafil , a phosphodiesterase-5 inhibitor , could be useful for treating pulmonary hypertension ( PH ) in chronic obstructive pulmonary disease ( COPD ) . However , vasodilators may inhibit hypoxic pulmonary vasoconstriction and impair gas exchange in this condition . OBJECTIVES To assess the acute hemodynamic and gas exchange effects of sildenafil in patients with COPD -associated PH . METHODS We conducted a r and omized , dose comparison trial in 20 patients with COPD -associated PH . Eleven patients were assigned to 20 mg , and 9 patients to 40 mg , of sildenafil . Pulmonary hemodynamics \n Output:\n " }, { "from": "agent", "value": "In conclusion , PH specific drugs ( especially sildenafil ) could improve exercise capacity and decrease PAP in COPD patients with severe PH" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective To determine whether outcomes of resuscitation with albumin or saline in the intensive care unit depend on patients ' baseline serum albumin concentration . Design Analysis of data from a double blind , r and omised controlled trial . Setting Intensive care units of 16 hospitals in Australia and New Zeal and . Participants 6045 participants in the saline versus albumin fluid evaluation ( SAFE ) study . Interventions Fluid resuscitation with 4 % albumin or saline in patients with a baseline serum albumin concentration of 25 g/l or less or more than 25 g/l . Main outcome measures Primary outcome was all cause mortality at 28 days . Secondary outcomes were length of stay in the intensive care unit , length of stay in hospital , duration of renal replacement therapy , and duration of mechanical ventilation . Main results The odds ratios for death for albumin compared with saline for patients with a baseline serum albumin concentration of 25 g/l or less and more than 25 g/l were 0.87 and 1.09 , respectively ( ratio of odds ratios 0.80 , 95 % confidence interval 0.63 to 1.02 ) ; P=0.08 for heterogeneity . No significant interaction was found between baseline serum albumin concentration as a continuous variable and the effect of albumin and saline on mortality . No consistent interaction was found between baseline serum albumin concentration and treatment effects on length of stay in the intensive care unit , length of hospital stay , duration of renal replacement therapy , or duration of mechanical ventilation . Conclusion The outcomes of resuscitation with albumin and saline are similar irrespective of patients ' baseline serum albumin concentration . Trial registration IS RCT N76588266 Objective Both albumin and synthetic colloids such as hydroxyethyl starch ( HES ) solution are used to optimize hemodynamics in the critically ill . The influence of different long-term infusion regimes on platelet function was studied . Design Prospect i ve , r and omized study . Setting Clinical investigation on a university hospital surgical intensive care unit . Patients Twenty-eight consecutive trauma patients ( injury severity score>15 points ) and 28 consecutive nontraumatized surgical patients with sepsis . Interventions The patients received either 20 % human albumin ( HA trauma , n=14 ; HA sepsis , n=14 ) or 10 % low-molecular-weight HES solution HES 200/0.5 ( HES trauma , n=14 ; HES sepsis;n=14 ) for 5 days to maintain central venous pressure and /or pulmonary capillary wedge pressure between 12 and 16 mmHg . Measurements and results Platelet function was assessed by aggregometry ( = turbidimetric technique ) using adenosine diphosphate 2.0 μmol/l , collagen 4 μl/ml , and epinephrine 25 μmol/l as inductors . Arterial blood was sample d on the day of admission or the day of diagnosis of sepsis ( = baseline value ) and over the next 5 days . St and ard coagulation parameters ( antithrombin III , fibrinogen , partial thromboplastin time ) were also measured . Total use of HES by the 5th day totalled 4870±990 ml in the trauma and 3260±790 ml in the sepsis patients ( HA trauma : 1850±380 ml ; HA sepsis : 1790±400 ml ) . Maximum platelet aggregation decreased significantly during the first 2–3 days after baseline in all groups . At the end of the investigation period , platelet aggregation variables had recovered and reached ( or even exceeded ) baseline values . Within the entire investigation period , the course of platelet aggregation variables did not differ significantly between HA and HES-treated patients irrespective of whether they were trauma or sepsis patients . Conclusions Alterations in hemostasis may occur for several reasons in the critically ill . Human albumin is the preferred first-line volume therapy in patients at risk for coagulation disorders . With respect to platelet function , volume replacement with ( lower-priced ) low-molecular-weight HES solutions can be recommended in this situation without any risk BACKGROUND It remains uncertain whether the choice of resuscitation fluid for patients in intensive care units ( ICUs ) affects survival . We conducted a multicenter , r and omized , double-blind trial to compare the effect of fluid resuscitation with albumin or saline on mortality in a heterogeneous population of patients in the ICU . METHODS We r and omly assigned patients who had been admitted to the ICU to receive either 4 percent albumin or normal saline for intravascular-fluid resuscitation during the next 28 days . The primary outcome measure was death from any cause during the 28-day period after r and omization . RESULTS Of the 6997 patients who underwent r and omization , 3497 were assigned to receive albumin and 3500 to receive saline ; the two groups had similar baseline characteristics . There were 726 deaths in the albumin group , as compared with 729 deaths in the saline group ( relative risk of death , 0.99 ; 95 percent confidence interval , 0.91 to 1.09 ; P=0.87 ) . The proportion of patients with new single-organ and multiple-organ failure was similar in the two groups ( P=0.85 ) . There were no significant differences between the groups in the mean ( + /-SD ) numbers of days spent in the ICU ( 6.5+/-6.6 in the albumin group and 6.2+/-6.2 in the saline group , P=0.44 ) , days spent in the hospital ( 15.3+/-9.6 and 15.6+/-9.6 , respectively ; P=0.30 ) , days of mechanical ventilation ( 4.5+/-6.1 and 4.3+/-5.7 , respectively ; P=0.74 ) , or days of renal-replacement therapy ( 0.5+/-2.3 and 0.4+/-2.0 , respectively ; P=0.41 ) . CONCLUSIONS In patients in the ICU , use of either 4 percent albumin or normal saline for fluid resuscitation results in similar outcomes at 28 days BACKGROUND Baseline data collected on each patient at r and omisation in controlled clinical trials can be used to describe the population of patients , to assess comparability of treatment groups , to achieve balanced r and omisation , to adjust treatment comparisons for prognostic factors , and to undertake subgroup analyses . We assessed the extent and quality of such practice s in major clinical trial reports . METHODS A sample of 50 consecutive clinical -trial reports was obtained from four major medical journals during July to September , 1997 . We tabulated the detailed information on uses of baseline data by use of a st and ard form . FINDINGS Most trials presented baseline comparability in a table . These tables were often unduly large , and about half the trials inappropriately used significance tests for baseline comparison . Methods of r and omisation , including possible stratification , were often poorly described . There was little consistency over whether to use covariate adjustment and the criteria for selecting baseline factors for which to adjust were often unclear . Most trials emphasised the simple unadjusted results and covariate adjustment usually made negligible difference . Two-thirds of the reports presented subgroup findings , but mostly without appropriate statistical tests for interaction . Many reports put too much emphasis on subgroup analyses that commonly lacked statistical power . INTERPRETATION Clinical trials need a predefined statistical analysis plan for uses of baseline data , especially covariate-adjusted analyses and subgroup analyses . Investigators and journals need to adopt improved st and ards of statistical reporting , and exercise caution when drawing conclusions from subgroup findings Symptomatic severe malarial anaemia ( SMA ) has a high fatality rate of 30–40 % ; most deaths occur in children awaiting blood transfusion . Blood transfusion services in most of Africa are not capable of delivering adequate supplies of safe blood in a timely manner to critically ill children with SMA . Contrary to widely held belief , hypovolaemia , rather than heart failure , has emerged as a common complication in such children . We examined the safety of pre‐transfusion management ( PTM ) by volume expansion , aim ed at stabilizing children and obviating the urgency for blood transfusion . Kenyan children with severe falciparum anaemia ( haemoglobin < 5 g/dl ) and respiratory distress were r and omly assigned to 20 ml/kg of 4·5 % albumin or 0·9 % saline or maintenance only ( control ) while awaiting blood transfusion . PTM was apparently safe since it did not lead to the development of pulmonary oedema or other adverse events . There was no significant difference in the primary outcome [ mean percentage reduction in base excess between admission and 8 h ( 95 % confidence interval ) ] between the control group 42 % ( 19–66 % ) albumin group 44 % ( 32–57 % ) and saline group 36 % ( 16–57 % ) ; adjusted analysis of variance F = 0·31 , P = 0·7 . However , the number of children requiring emergency interventions was significantly greater in the control group , four of 18 ( 22 % ) than the saline group 0 of 20 ( P = 0·03 ) . We have established the safety of this PTM in children with SMA whilst awaiting blood transfusion at a hospital with an adequate blood‐banking program . The impact on mortality should be assessed where blood transfusion services are unable to supply emergency transfusions BACKGROUND / AIMS Recent studies demonstrated that extravascular lung water ( EVLW ) is a reliable and independent marker for outcome . The primary therapeutically goal in critically ill patients is to resuscitate and retain adequate organ perfusion by fluid administration , where is necessary to achieve adequate intravascular filling , but avoid initiation of pulmonary edema . METHODOLOGY Patients with severe sepsis were r and omly allocated to a group treated with 20 % Albumin 100 ml every 12 hours ( ALB ; n = 30 ) or with 6 % hydroxyethylstarch 130/0 , 4 250 ml every 6 hours ( HES ; n = 26 ) . Both treatments were completed by crystalloids or norephinephrin as necessary . We analyzed amount of developed EVLW , and relation with mortality , PaO2/FiO2 and alveolo-arterial oxygen difference . RESULTS We observed significantly greater decrease of EVLW when compared with baseline during whole monitored period of 72 hours in ALB group in contrast to HES patients ( p < 0.05 ) . Despite no significant changes of EVLW in HES group , we noted improve of PaO2/FiO2 and AaDO2 in both groups . We did not observed significant difference in mortality . CONCLUSION The present study results show can summarize that albumin reduces in a higher amount and earlier the extravascular lung water than HES , but this reduction was not associated with improvement of oxygenation functions , which was better in HES group BACKGROUND Metabolic acidosis is the best predictor of death in children with severe falciparum malaria ; however , its treatment presents a therapeutic dilemma , because acidosis and hypovolemia may coexist with coma , which can be associated with elevated intracranial pressure . We postulated that volume resuscitation with albumin might correct acidosis and hypovolemia with a lower risk of precipitating cerebral edema than crystalloid . In an open-label , r and omized , controlled trial , we compared the safety of resuscitation with albumin to saline in Kenyan children with severe malaria . METHODS We r and omly assigned children with severe malaria and metabolic acidosis ( base deficit , > 8 mmol/L ) to receive fluid resuscitation with either 4.5 % albumin or normal saline . A control ( maintenance only ) group was only included for patients with a base deficit of < 15 mmol/L. The primary outcome measure was the percentage reduction in base deficit at 8 h. Secondary end points included death , the requirement for rescue therapies , and neurological sequelae in survivors . RESULTS Of 150 children recruited for the trial , 61 received saline , 56 received albumin , and 33 served as control subjects . There was no significant difference in the resolution of acidosis between the groups ; however , the mortality rate was significantly lower among patients who received albumin ( 3.6 % [ 2 of 56 patients ] ) than among those who received saline ( 18 % [ 11 of 61 ] ; relative risk , 5.5 ; 95 % confidence interval , 1.2 - 24.8 ; P=.013 ) . CONCLUSIONS In high-risk children with severe malaria and acidosis , fluid resuscitation with albumin may reduce mortality . Our study design did not enable us to determine whether saline administration is preferable to fluid restriction or whether saline administration is actually hazardous . Further studies are needed to confirm our findings before definitive treatment recommendations can be made Various vasoactive substances are involved in the regulation of the macro- and microcirculation . We have investigated if these regulators change during long-term volume therapy with human albumin ( HA ) or hydroxyethylstarch solution ( HES ) in trauma and sepsis patients . To maintain pulmonary capillary wedge pressure ( PCWP ) at 10 - 15 mm Hg , either 20 % HA ( HA-trauma , n = 14 ; HA-sepsis , n = 14 ) or 10 % low-molecular weight HES solution ( HES-trauma , n = 14 ; HES-sepsis , n = 14 ) were infused for 5 days , otherwise patient management did not differ between the two groups ( trauma/sepsis ) . Mean \n Output:\n " }, { "from": "agent", "value": "In this meta- analysis , the use of albumin-containing solutions for the resuscitation of patients with sepsis was associated with lower mortality compared with other fluid resuscitation regimens ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE To determine whether a single session of anodal transcranial direct current stimulation to the left dorsolateral prefrontal cortex improves attention in patients with traumatic brain injury . DESIGN Double-blinded , cross-over design . PATIENTS Nine patients with attention deficit after traumatic brain injury . METHODS Patients underwent a computerized contrast reaction time task before and after the administration of real transcranial direct current stimulation ( 2 mA for 20 min ) or sham transcranial direct current stimulation ( 2 mA for 1 min ) to the left dorsolateral prefrontal cortex in a double-blind , crossover manner . RESULTS Immediately post-stimulation , the transcranial direct current stimulation group showed a tendency of shortened reaction time relative to baseline ( 87.3 ± 7.8 % ) , whereas the sham stimulation group ( 122.4 ± 715.5 % ) did not ( p = 0.056 ) . However , this difference was not significant 3 or 24 h after stimulation ( p > 0.05 ) . The numbers of correct responses were not changed at any time after stimulation . CONCLUSION Anodal transcranial direct current stimulation applied to the left dorsolateral prefrontal cortex improves attention compared with sham stimulation in patients with traumatic brain injury , which suggests a potential role for this intervention in improving attention during cognitive training after traumatic brain injury . A further prospect i ve r and omized trial is required to confirm the benefits conferred by transcranial direct current stimulation in this patient population The present study investigated emotional memory following bilateral transcranial electrical stimulation ( direct current of 1 mA , for 20 minutes ) over fronto-temporal cortical areas of healthy participants during the encoding of images that differed in affective arousal and valence . The main result was a significant interaction between the side of anodal stimulation and image emotional valence . Specifically , right anodal/left cathodal stimulation selectively facilitated the recall of pleasant images with respect to both unpleasant and neutral images whereas left anodal/right cathodal stimulation selectively facilitated the recall of unpleasant images with respect to both pleasant and neutral images . From a theoretical perspective , this double dissociation between the side of anodal stimulation and the advantage in the memory performance for a specific type of stimulus depending on its pleasantness supported the specific-valence hypothesis of emotional processes , which assumes a specialization of the right hemisphere in processing unpleasant stimuli and a specialization of the left hemisphere in processing pleasant stimuli . From a method ological point of view , first we found tDCS effects strictly dependent on the stimulus category , and second a pattern of results in line with an interfering and inhibitory account of anodal stimulation on memory performance . These findings need to be carefully considered in applied context s , such as the rehabilitation of altered emotional processing or eye-witness memory , and deserve to be further investigated in order to underst and their underlying mechanisms of action Cognitive control ( CC ) over emotional distraction is of particular importance for adaptive human behaviour and is associated with activity in the left dorsolateral prefrontal cortex ( dlPFC ) . Deficient CC , e.g. , presenting as negativity bias , has been suggested to underlie many of the core symptoms of major depression ( MD ) and is associated with impairments of dlPFC function . Correspondingly , enhancement of dlPFC activity with anodal transcranial direct current stimulation ( tDCS ) can ameliorate these impairments in patients with MD . Here , we tested the hypothesis that a reduction of dlPFC activity by cathodal tDCS induces CC deficits , thus triggering a depression-like negativity bias in healthy subjects . Twenty-eight individuals participated in a double-blinded , balanced r and omized crossover trial of cathodal ( 1 mA , 20 min ) and sham tDCS applied to the left dlPFC . To assess CC we conducted a delayed response working memory ( DWM ) task and an arithmetic inhibition task ( AIT ) with pictures of varying valent content ( negative , neutral , positive ) during and immediately after stimulation . Cathodal tDCS led to impaired CC specifically over negative material as assessed by reduced response accuracy in the DWM and prolonged response latency in the AIT . Hence , the current study supports the notion that left dlPFC is critically involved in CC over negative material . Together with previously reported beneficial anodal effects , it indicates that the hypoactivation of left dlPFC causes deficits in CC over negative material , which is a possible aetiological mechanism of depression In this study , we explored the representation of an incongruent action ( instrumentally incorrect use of an object ) in comparison with sentences ending with an incongruent action word , taking into account the role of the activation of the left dorsolateral pFC ( DLPFC ) . This activity was appositely modulated by transcranial direct current stimulation ( tDCS ) . The effect of tDCS when participants processed congruent/incongruent object-related actions ( Experiment 1 ) or sentences ( Experiment 2 ) was verified by measuring changes in the ERP N400 , error rates ( ERs ) , and RTs . In Experiment 1 , 30 participants performed the detection task within a dynamic context ( video tapes representing a sequence of four action frames ) . In Experiment 2 , 28 participants read sentences that represented object-related actions . The stimulation effect ( a cathode applied to the DLPFC and an anode to the right supraorbital region ) was analyzed by comparing the ER , RT , and ERP profiles before and after stimulation ( or sham treatment ) . A significant reduction of the N400 was observed for incongruent stimuli in the case of cathodal ( inhibitory ) stimulation of the DLPFC in comparison with prestimulation conditions for Experiment 1 , but not Experiment 2 . Moreover , ERs were increased , and RTs were reduced in response to incongruent conditions after tDCS , but not after sham stimulation in Experiment 1 . It is suggested that perturbation of the DLPFC may limit the ability to analyze a semantically anomalous action sequence as a reduced N400 ERP effect and increased r and om responses was observed . Finally , the contribution of the frontal area to the semantic processing of actions is discussed BACKGROUND Transcranial direct current stimulation ( tDCS ) is increasingly discussed as a new option to support the cognitive rehabilitation in neuropsychiatric disorders . However , the therapeutic impact of tDCS is limited by high inter-individual variability . Genetic factors most likely contribute to this variability by modulating the effects of tDCS . OBJECTIVES We aim ed to investigate the influence of the COMT Val(108/158)Met polymorphism on cathodal tDCS effects on executive functioning . METHODS Cathodal tDCS was applied to the left dorsolateral prefrontal cortex ( dlPFC ) during the performance of a parametric Go/No-Go test . RESULTS We demonstrate an impairing effect of cathodal tDCS to the dlPFC on response inhibition . This effect was only found in individuals homozygous for the Val-allele of the COMT Val(108/158)Met polymorphism . No effects of stimulation on executive functions in Met-allele carriers were detected . CONCLUSION Our data indicate that i ) cathodal , excitability reducing tDCS , interferes with inhibitory cognitive control , ii ) the left dlPFC is critically involved in the neuronal network underlying the control of response inhibition , and iii ) the COMT Val(108/158)Met polymorphism modulates the impact of cathodal tDCS on inhibitory control . Together with our previous finding that anodal tDCS selectively impairs set-shifting abilities in COMT Met/Met homozygous individuals , these results indicate that genetic factors modulate effects of tDCS on cognitive performance . Therefore , future tDCS research should account for genetic variability in the design and analysis of neurocognitive as well as therapeutic applications to reduce the variability of results and facilitate individualized neurostimulation approaches The time-dependent effect of transcranial direct current stimulation ( tDCS ) on working memory was investigated by applying anodal stimulation over the left prefrontal cortex . This single-blind , sham-controlled crossover study recruited 15 healthy participants . A three-back verbal working-memory task was performed before , during , and 30 min after 1 mA anodal or sham tDCS . Anodal tDCS , compared with sham stimulation , significantly improved working-memory performance . Accuracy of response was significantly increased after 20 min of tDCS application , and was further enhanced after 30 min of stimulation . This effect was maintained for 30 min after the completion of stimulation . These results suggest that tDCS at 1 mA enhances working memory in a time-dependent manner for at least 30 min in healthy participants Background : Word retrieval during verbal fluency tasks invokes both automatic and controlled cognitive processes . A distinction has been made between the generation of words clusters and switches between such clusters on verbal fluency tasks . Clusters , defined by the reporting of contiguous words that constitute semantic or phonemic subcategories , are thought to reflect relatively automatic processing . In contrast , switching from one subcategory to another is thought to require a more controlled , effortful form of cognitive processing . Objective : In this single-blind , sham-controlled experiment , we investigated whether anodal and cathodal transcranial direct current stimulation ( tDCS ) can differentially modify controlled or automatic processes that support lexical retrieval , as assessed by clustering and switching on verbal fluency tasks , in 24 healthy right-h and ed adults . Methods : Participants were r and omly assigned to receive 1 mA of either anodal ( excitatory ) or cathodal ( inhibitory ) active tDCS over the left dorsolateral prefrontal cortex in addition to sham stimulation over the same region in counterbalanced order . Participants engaged in various cognitive activities during the first 23 min of stimulation . Then , during the final segment of each 30-min session , they completed letter- and category-cued word fluency tasks . Results : Participants reported more words on category-cued word fluency tasks during anodal than sham stimulation ( 25.9 vs. 23.0 words ; p = 0.055 ) . They also showed a net increase in the number of clustered words during anodal stimulation compared to a net decrease during cathodal stimulation ( 1.3 vs. −1.5 words ; p = 0.038 ) . Conclusion : tDCS can selectively alter automatic aspects of speeded lexical retrieval in a polarity-dependent fashion during a category-guided fluency task PURPOSE Attention decline after stroke is common and hampers the rehabilitation process , and non-invasive transcranial direct current stimulation ( tDCS ) has the potential to elicit behavioral changes by modulating cortical excitability . The authors tested the hypothesis that a single session of non-invasive cortical stimulation with excitatory anodal tDCS applied to the left dorsolateral prefrontal cortex ( DLPFC ) can improve attention in stroke patients . METHODS Ten patients with post-stroke cognitive decline ( MMSE 25 ) and 10 age-matched healthy controls participated in this double blind , sham-controlled , crossover study involving the administration of real ( 2 mA for 20 min ) or sham stimulation ( 2 mA for 1 min ) to the left DLPFC . Attention was measured using a computerized Go/No-Go test before and after intervention . Improvements in accuracy and speed after stimulation relative to baseline were compared for real and sham stimulations . RESULTS In healthy controls , no significant improvement in Go/No-Go test was observed after either real or sham stimulation . However , in stroke patients , tDCS led to a significant improvement in response accuracy at 1 hour post-stimulation relative to baseline , and this improvement was maintained until 3 hours post-stimulation ( P < 0.05 ) , whereas sham stimulation did not lead to a significant improvement in response accuracy ( P > 0.05 ) . Changes in reaction times were comparable for the two stimulations ( P > 0.05 ) . CONCLUSION Non invasive anodal tDCS applied to the left DLPFC was found to improve attention versus sham stimulation in stroke patients , which suggests that non-invasive cortical intervention could potentially be used during rehabilitative training to improve attention Introduction Working memory plays a critical role in cognitive processes which are central to our daily life . Neuroimaging studies have shown that one of the most important areas corresponding to the working memory is the dorsolateral prefrontal cortex ( DLFPC ) . This study was aim ed to assess whether bilateral modulation of the DLPFC using a noninvasive brain stimulation , namely transcranial direct current stimulation ( tDCS ) , modifies the working memory function in healthy adults . Methods In a r and omized sham-controlled cross-over study , 60 subjects ( 30 Males ) received sham and active tDCS in two subgroups ( anode left/cathode right and anode right/cathode left ) of the DLPFC . Subjects were presented working memory n-back task while the reaction time and accuracy were recorded . Results A repeated measures , mixed design ANOVA indicated a significant difference between the type of stimulation ( sham vs. active ) in anodal stimulation of the left DLPFC with cathodal stimulation of the right DLPFC [ F(1,55)= 5.29 , P=0.019 ] , but not the inverse polarity worsened accuracy in the 2-back working memory task . There were also no statistically significant changes in speed of working memory [ F(1,55)= 0.458,P=0.502 ] related to type or order of stimulation . Discussion The results would imply to a polarity dependence of bilateral tDCS of working memory . Left anodal/ right cathodal stimulation of DLP \n Output:\n " }, { "from": "agent", "value": "Importantly , different stimulation parameters affected a-tDCS effects , but not c-tDCS effects , on accuracy in healthy sample s vs. PATIENTS increased current density and density charge result ed in improved accuracy in healthy sample s , most prominently in females ; for neuropsychiatric patients , task performance during a-tDCS result ed in stronger increases in accuracy rates compared to task performance following a-tDCS .\nCONCLUSIONS Healthy participants respond faster , but not more accurate on cognitive tasks after a-tDCS .\nHowever , increasing the current density and /or charge might be able to enhance response accuracy , particularly in females .\nIn contrast , online task performance leads to greater increases in response accuracy than offline task performance in neuropsychiatric patients ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: INTRODUCTION There is growing evidence that the mailed distribution of free nicotine replacement therapy ( NRT ) , usually as part of smokers ' helplines , can been effective in increasing the odds of cessation on a population level . However , limited information is available on the utilization of NRT when it is provided for free , and factors associated with regimen adherence have remained largely unexplored . METHODS In the context of a r and omized controlled trial , 500 adult smokers across Canada hypothetically interested in free NRT were mailed a 5week supply of nicotine patches , but no other support was offered . Analyses evaluated which a priori-defined demographic and smoking characteristics predicted nicotine patch use at 8week follow-up of 421 patch recipients , as well as examined the association between patch use and smoking cessation at 6months . RESULTS At 8weeks , 10.9 % had used all , 47.5 % had used some but not all , and 41.6 % had not used any of the provided nicotine patches . Lower age , unemployment , past NRT use and intent to quit in the next 30days at baseline ( preparation stage of change ) were all identified as independent predictors of some nicotine patch use . Only use of all patches was associated with greater odds of smoking cessation , compared to non-users ( Adj . OR=2.96 ; 95%CI=1.06 - 8.27 ) . CONCLUSIONS The mailed distribution of free nicotine patches to smokers at large can be effective at promoting cessation , particularly among financially disadvantaged groups , those with previous NRT experience and among individuals with already advanced intent to quit AIMS To propose a hierarchy of method ological criteria to consider when determining whether a study provides sufficient information to answer the question of whether e-cigarettes can facilitate cigarette smoking cessation or reduction . DESIGN A PubMed search to 1 February 2017 was conducted of all studies related to e-cigarettes and smoking cessation or reduction . SETTING S Australia , Europe , Iran , Korea , New Zeal and and the United States . PARTICIPANTS AND STUDIES 91 articles . MEASUREMENTS Coders organized studies according to six proposed method ological criteria : ( 1 ) examines outcome of interest ( cigarette abstinence or reduction ) , ( 2 ) assesses e-cigarette use for cessation as exposure of interest , ( 3 ) employs appropriate control/comparison groups , ( 4 ) ensures that measurement of exposure precedes the outcome , ( 5 ) evaluates dose and duration of the exposure and ( 6 ) evaluates the type and quality of the e-cigarette used . FINDINGS Twenty-four papers did not examine the outcomes of interest . Forty did not assess the specific reason for e-cigarette use as an exposure of interest . Twenty papers did not employ prospect i ve study design s with appropriate comparison groups . The few observational studies meeting some of the criteria ( duration , type , use for cessation ) triangulated with findings from three r and omized trials to suggest that e-cigarettes can help adult smokers quit or reduce cigarette smoking . CONCLUSIONS Only a small proportion of studies seeking to address the effect of e-cigarettes on smoking cessation or reduction meet a set of proposed quality st and ards . Those that do are consistent with r and omized controlled trial evidence in suggesting that e-cigarettes can help with smoking cessation or reduction \n Output:\n " }, { "from": "agent", "value": "We found mixed patterns of e-cigarette current use by SES , with evidence of higher use among low-income adults but unclear or mixed findings by education and occupation .\nIn contrast , smokeless tobacco current use was consistently higher among low SES adults .\nThere was very limited evidence on the SES distribution of NRT in adults and of all NCNPs in young people .\nThe only NCNP for which there are clear patterns of use by SES is smokeless tobacco , where prevalence is higher among low SES groups .\nWhile this suggests a potentially positive impact on inequalities in smoking ( if NCNP use displaces smoked tobacco use ) , this has not been seen in practice .\nThese findings do not support the suggestion that e-cigarettes have the potential to reduce social inequalities in smoking , since i ) current evidence does not show a clear trend of higher e-cigarette use in population groups with higher tobacco consumption , and ii ) the experience of smokeless tobacco suggests that – even where NCNP use is higher among low SES groups – this does not necessarily replace smoked tobacco use in these groups" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The effects of vascular endothelial growth factor ( VEGF ) blockade on the vascular biology of human tumors are not known . Here we show here that a single infusion of the VEGF-specific antibody bevacizumab decreases tumor perfusion , vascular volume , microvascular density , interstitial fluid pressure and the number of viable , circulating endothelial and progenitor cells , and increases the fraction of vessels with pericyte coverage in rectal carcinoma patients . These data indicate that VEGF blockade has a direct and rapid antivascular effect in human tumors PURPOSE Mutations affecting the KRAS gene are established predictive markers of outcome with anti-epithelial growth factor receptor ( EGFR ) antibodies in advanced colorectal cancer ( CRC ) . The relevance of these markers for anti-vascular endothelial growth factor ( VEGF ) therapy is controversial . This analysis was performed to assess the predictive and prognostic impact of KRAS and BRAF gene mutation status in patients receiving capecitabine with bevacizumab ( CG ) or capecitabine without bevacizumab in the phase III AGITG MAX ( Australasian Gastrointestinal Trials Group MAX ) study . PATIENTS AND METHODS Mutation status was determined for 315 ( 66.9 % ) of the original 471 patients . Mutation status was correlated with efficacy outcomes ( response rate , progression-free survival [ PFS ] , and overall survival [ OS ] ) , and a predictive analyses was undertaken . RESULTS Mutations in KRAS and BRAF genes were observed in 28.8 % and 10.6 % of patients , respectively . KRAS gene mutation status ( wild type [ WT ] v mutated [ MT ] ) had no prognostic impact for PFS ( hazard ratio [ HR ] , 0.89 ; CI , 0.69 to 1.14 ) or OS ( HR , 0.97 ; CI , 0.73 to 1.28 ) . BRAF mutation status ( WT v MT ) was not prognostic for PFS ( HR , 0.80 ; CI , 0.54 to 1.18 ) but was prognostic for OS ( HR , 0.49 ; CI , 0.33 to 0.73 ; P = .001 ) . By using the comparison of capecitabine versus capecitabine and bevacizumab ( CB ) and CB plus mitomycin ( CBM ) , KRAS gene mutation status was not predictive of the effectiveness of bevacizumab for PFS or OS ( test for interaction P = .95 and 0.43 , respectively ) . Similarly , BRAF gene mutation status was not predictive of the effectiveness of bevacizumab for PFS or OS ( test for interaction P = .46 and 0.32 , respectively ) . CONCLUSION KRAS gene mutation status was neither prognostic for OS nor predictive of bevacizumab outcome in patients with advanced CRC . BRAF gene mutation status was prognostic for OS but was not predictive of outcome with bevacizumab This study evaluates the efficacy of capecitabine using data from a large , well-characterised population of patients with metastatic colorectal cancer ( mCRC ) treated in two identically design ed phase III studies . A total of 1207 patients with previously untreated mCRC were r and omised to either oral capecitabine ( 1250 mg m−2 twice daily , days 1−14 every 21 days ; n=603 ) or intravenous ( i.v . ) bolus 5-fluorouracil/leucovorin ( 5-FU/LV ; Mayo Clinic regimen ; n=604 ) . Capecitabine demonstrated a statistically significant superior response rate compared with 5-FU/LV ( 26 vs 17 % ; P<0.0002 ) . Subgroup analysis demonstrated that capecitabine consistently result ed in superior response rates ( P<0.05 ) , even in patient subgroups with poor prognostic indicators . The median time to response and duration of response were similar and time to progression ( TTP ) was equivalent in the two arms ( hazard ratio ( HR ) 0.997 , 95 % confidence interval ( CI ) 0.885–1.123 , P=0.95 ; median 4.6 vs 4.7 months with capecitabine and 5-FU/LV , respectively ) . Multivariate Cox regression analysis identified younger age , liver metastases , multiple metastases and poor Karnofsky Performance Status as independent prognostic indicators for poor TTP . Overall survival was equivalent in the two arms ( HR 0.95 , 95 % CI 0.84–1.06 , P=0.48 ; median 12.9 vs 12.8 months , respectively ) . Capecitabine results in superior response rate , equivalent TTP and overall survival , an improved safety profile and improved convenience compared with i.v . 5-FU/LV as first-line treatment for MCRC . For patients in whom fluoropyrimidine monotherapy is indicated , capecitabine should be strongly considered . Following encouraging results from phase I and II trials , r and omised trials are evaluating capecitabine in combination with irinotecan , oxaliplatin and radiotherapy . Capecitabine is a suitable replacement for i.v . 5-FU as the backbone of colorectal cancer therapy Objective : The objective of this phase III trial was to compare chemotherapy combined with bevacizumab versus chemotherapy alone in the treatment of patients with advanced colorectal cancer . Methods : From September 2004 till September 2008 , 222 treatment-naive patients were enrolled and divided into 2 arms : 114 arm A patients were treated with leucovorin , 5-fluorouracil plus irinotecan in combination with bevacizumab , and 108 arm B patients were treated as above without bevacizumab . All patients were stage IV with histologically confirmed adenocarcinoma . Results : The median overall survival of arm A patients was 22.0 months ( 95 % CI : 18.1–25.9 ) and 25.0 months ( CI : 18.1–31.9 ) for arm B patients . There was no statistically significant difference between the 2 arms ( p = 0.1391 ) . No statistically significant difference between the 2 arms regarding the response ratewas observed : partial response , 42 patients ( 36.8 % ) and 38 patients ( 35.2 % ) for arms A and B , respectively . Hematologic toxicity did not differ in the comparison of the 2 arms . Nonhematologic toxicity in arm A involved hypertension in 23 ( 20.2 % ) of the patients and proteinuria in 7 ( 6.1 % ) ; 3 patients experienced hemorrhage and 1 patient intestinal perforation . None of these side effects was observed in arm B patients . Conclusion : No statistically significant difference in median overall survival in patients with advanced colorectal cancer treated with bevacizumab plus a combination therapy ( arm A ) and those treated with the combination only , without bevacizumab ( arm B ) , was observed This multicenter , Phase II trial was performed to evaluate the antitumor activity and toxicity of irinotecan ( CPT‐11 ) in patients with metastatic colorectal carcinoma that had recurred or progressed after 5‐fluorouracil (5‐FU)‐based chemotherapy PURPOSE Tumor angiogenesis mediated by vascular endothelial growth factor ( VEGF ) is inhibited by the recombinant humanized ( rhu ) monoclonal antibody ( MAb ) rhuMAbVEGF , which has synergy with chemotherapy in animal models . The present study was design ed to assess the safety and pharmacokinetics of weekly intravenous ( IV ) rhuMAbVEGF with one of three st and ard chemotherapy regimens . PATIENTS AND METHODS Twelve adult patients were enrolled four on each combination . rhuMAbVEGF , 3 mg/kg IV , was administered weekly for 8 weeks with ( 1 ) doxorubicin 50 mg/m(2 ) every 4 weeks ; ( 2 ) carboplatin at area under the curve of 6 plus paclitaxel 175 mg/m(2 ) every 4 weeks ; and ( 3 ) fluorouracil ( 5-FU ) 500 mg/m(2 ) with leucovorin 20 mg/m(2 ) weekly , weeks 1 to 6 every 8 weeks . RESULTS The median number of rhuMAbVEGF doses delivered was eight ( range , four to eight doses ) . Grade 3 toxicities were diarrhea ( one 5-FU patient ) , thrombocytopenia ( two patients on carboplatin plus paclitaxel ) , and leukopenia ( one patient on carboplatin plus paclitaxel ) . These toxicities were likely attributable to the chemotherapy component of the regimen . The mean ( + /- SD ) peak serum level of rhuMAbVEGF was 167 + /- 46 microg/mL , and the mean terminal half-life was 13 days . Total ( free plus bound ) serum VEGF levels increased from 51 + /- 39 pg/mL ( day 0 ) to 211 + /- 112 ( day 49 ) pg/mL. Three responding patients continued treatment with rhuMAbVEGF and chemotherapy , receiving the equivalent of 36 , 20 , and 40 total rhuMAbVEGF doses with no cumulative or late toxicities . CONCLUSION rhuMAbVEGF can be safely combined with chemotherapy at doses associated with VEGF blockade and without apparent synergistic toxicity . Its contribution to the treatment of advanced solid tumors should be evaluated in r and omized treatment trials On June 20 , 2006 , the U.S. Food and Drug Administration ( FDA ) approved bevacizumab ( Avastin ; Genentech , Inc. , South San Francisco , CA ) , administered in combination with FOLFOX4 ( 5-fluorouracil , leucovorin , and oxaliplatin ) for the second-line treatment of metastatic carcinoma of the colon or rectum . Efficacy and safety were demonstrated in one Eastern Cooperative Oncology Group ( ECOG ) open-label , multicenter , r and omized , three-arm , active-controlled trial enrolling 829 adult patients . Patients had received a fluoropyrimidine- and irinotecan-based regimen as initial therapy for metastatic disease ; or they had received prior adjuvant irinotecan-based chemotherapy and had recurred within 6 months of completing therapy . Treatments included bevacizumab , 10 mg/kg , as a 90-minute i.v . infusion on day 1 , every 2 weeks , either alone or in combination with FOLFOX4 , or FOLFOX4 alone . The bevacizumab monotherapy arm was closed to accrual after an interim efficacy analysis suggested a possibly shorter survival in that arm . Overall survival ( OS ) , the primary study endpoint , was significantly longer for patients receiving bevacizumab in combination with FOLFOX4 than for those receiving FOLFOX4 alone . The objective response rate was significantly higher in the FOLFOX4 plus bevacizumab arm than in the FOLFOX4 alone arm . The duration of response was approximately 6 months for both treatment arms . Patients treated with the bevacizumab combination were also reported , based on investigator assessment , to have significantly longer progression-free survival . There were no new bevacizumab safety signals . The most serious , and sometimes fatal , bevacizumab toxicities are gastrointestinal perforation , wound-healing complications , hemorrhage , arterial thromboembolic events , hypertensive crisis , nephrotic syndrome , and congestive heart failure PURPOSE The National Surgical Adjuvant Breast and Bowel Project C-08 trial was design ed to investigate the safety and effectiveness of adding bevacizumab to modified infusional fluorouracil , leucovorin , and oxaliplatin ( FOLFOX ) 6 regimen for the adjuvant treatment of patients with stage II or III colon cancer . We present safety information in advance of the planned analysis of efficacy . PATIENTS AND METHODS Among 2,710 r and omly assigned patients , demographic factors were balanced . Patients received modified FOLFOX6 every 2 weeks x 12 or modified FOLFOX6 plus bevacizumab ( 5 mg/kg every 2 weeks x 26 , experimental group ) . RESULTS Overall rates of grade 4 or 5 toxicities were nearly identical in the FOLFOX6 and FOLFOX6 plus bevacizumab arms ( 15.2 % and 15.0 % , respectively ) . Six-month mortality rates were 0.96 % and 0.90 % for the control and experimental groups , respectively . Grade 3 + toxicities that occurred more often in the experimental arm versus control arm included hypertension ( 12 % v 1.8 % , respectively ) , wound complications ( abdominal incisional hernia or infusion port dehiscence/inflammation ; 1.7 % v 0.3 % , respectively ) , pain ( 11.1 % v 6.3 % , respectively ) , and proteinuria ( 2.7 % v 0.8 % , respectively ) . Grade 2 + neuropathy was increased in the experimental arm versus \n Output:\n " }, { "from": "agent", "value": "Subgroup analyses stratified by CTX was also performed , evident benefits of additional BEV in OS and PFS can be identified in all subgroups , except for the CTX containing capecitabine in OS .\nMoreover , the increased rate of incidence was also identified in hypertension , thrombosis , proteinuria , gastrointestinal perforation , and fatigue .\nBEV , acting as a targeted agent to CTX , its additional benefit to CTX is at the cost of increased toxicity" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Ocular adnexal MALT lymphoma ( OAML ) is linked to Chlamydophila psittaci ( Cp ) infection . Viability and infectivity of Cp , demonstrated by growth in culture , has not been yet investigated in these patients . We conducted a single-center prospect i ve case-control study to assess the prevalence , viability and infectivity of Cp in 20 OAML patients and 42 blood donors registered in a 6-month period . The presence of Cp in conjunctival swabs and peripheral blood mononuclear cells ( P BMC ) of patients and donors was assessed by TETR-PCR and in vitro cultures . From an epidemiological point of view , OAML patients often resided in rural areas , and reported a history of chronic conjunctivitis and prolonged contact with household animals ( 85 % vs. 38 % of donors ; p = 0.00001 ) . Cp was detected in lymphoma tissue in 15 ( 75 % ) patients . Cp DNA was detected in conjunctival swabs and /or P BMC from 10 ( 50 % ) patients and in P BMC from 1 ( 2 % ) donor ( p = 0.01 ) . Viability and infectivity of Cp , demonstrated by growth in culture , were confirmed in conjunctival swabs and /or P BMC from 5 ( 25 % ) patients , but not in donors ( p = 0.002 ) . This prospect i ve study demonstrates , for the first time , that Cp present in the conjunctiva and P BMC of OAML patients is capable to grow and be isolated in cell cultures . Cp infection is common in OAML patients and exceptional in blood donors . Epidemiological data of OAML patients ( prolonged contact with household animals and chronic conjunctivitis ) are consistent with Cp exposure risk Infectious agents have been identified as a major cause of specific types of human cancers worldwide . Several microorganisms have been identified as potential aggravators of ocular adnexal neoplasms ; however , given the rarity of these neoplasms , large epidemiological studies are difficult to coordinate . This study aim ed to conduct an exhaustive search for pathogenic DNA in lymphoproliferative disorders ( LPD ) of the ocular adnexa in a total of 70 patients who were diagnosed with LPD of the ocular adnexa between 2008 and 2013 . Specimens were screened for bacterial , viral , fungal , and parasitic DNA by multiplex polymerase chain reaction ( PCR ) and quantitative real-time PCR . Among cases of conjunctival mucosa-associated lymphoid tissue lymphoma , human herpes virus (HHV)-6 , HHV-7 , chlamydia , Epstein-Barr virus ( EBV ) and bacterial 16S ribosomal DNA were detected . In cases of IgG4-related ocular disease , similar pathogens were detected but in a larger number of patients . Our PCR assays detected DNAs of various infectious agents in tumor specimens , especially HHV6 , HHV7 , and EBV , with different positive rates in various types of LPD . Chronic inflammatory stimulation or activation of oncogenes from these infectious agents might be involved in the pathogenesis of LPD of the ocular adnexa Purpose : Chlamydia psittaci ( Cp ) has been associated to ocular adnexal lymphomas ( OAL ) with variable geographic distribution . Herein , we used multiple Chlamydia detection tools to identify Cp elementary bodies – containing cell and to assess Cp prevalence in both nodal and extranodal lymphomas . Experimental Design : TETR-PCR , immunohistochemistry , immunofluorescence , electron microscopy , and laser-capture microdissection were done in 35 OALs to define their effect in Chlamydia detection and , moreover , to identify the Cp cellular carrier . Cp prevalence was screened by TETR-PCR in 205 extraorbital lymphomas and 135 nonneoplastic controls . Results : Twenty-six ( 74 % ) OALs were associated with Cp infection : immunohistochemistry , immunofluorescence , and laser-capture microdissection-assisted PCR showed that monocytes/macrophages were the Cp carriers ; electron microscopy showed the presence of intact Cp elementary bodies into these cells . Immunohistochemistry and TETR-PCR showed a 70 % concordance rate ( P = 0.001 ) . Cp DNA was equally prevalent in non-OAL , nodal , and extranodal lymphomas : among the latter , it was more common in diffuse large B-cell lymphomas of the skin ( P = 0.03 ) and Waldeyer 's ring . Conclusions : This multiparametric approach shows , for the first time , that monocytes/macrophages are the carriers of Cp , Cp seems preferentially associated with lymphomas arising in organs primarily exposed to antigens . The clinical implication s of these findings deserve to be prospect ively investigated CHLAMYDIA AND OCULAR ADNEXAL LYMPHOMAS AN INDIAN EXPERIENCE : Ocular adnexal lymphomas ( OALs ) are a heterogeneous group of malignancies , majority being extranodal mucosa-associated lymphoid tissue ( MALT ) type . Different geographical regions have reported association of Chlamydia with OALs ( MALT type ) . In India , role of Chlamydia in OALs remains unexplored . The aim of this study was to detect Chlamydia and to correlate with clinicopathological features of OALs in India . The clinicopathological features of 41 OAL cases were studied prospect ively . Chlamydia DNA was detected by genus specific PCR amplifying major outer membrane protein ( MOMP ) gene followed by DNA sequencing . Chlamydia immunoexpression was evaluated by immunofluorescence and immunohistochemistry . The results were correlated with clinicopathological features including follow-up and survival . Chlamydia genome was detected in 3/41 ( 7.3 % ) OAL cases by PCR . Direct sequencing revealed C. trachomatis in 3 positive cases . Immunofluorescence and immunohistochemistry showed Chlamydia antigen in 5/41 and 1/41 cases respectively . Immunofluorescence demonstrated higher sensitivity than immunohistochemistry . A significant association was observed between Chlamydia positivity and orbital location ( P=0.05 ) . Follow-up revealed relapse in 2 Chlamydia positive cases ( P=0.056 ) . Our results demonstrate for the first time presence of C. trachomatis genome in 7.3 % OAL cases in India . As no other reports are documented , more detailed studies from different regions within India are needed to explore status of Chlamydia in OALs BACKGROUND An association between ocular adnexal MALT lymphoma ( OAL ) and Chlamydia psittaci ( Cp ) infection has been proposed , and recent reports suggest that doxycycline treatment causes tumor regression in patients with Cp-related OAL . The effectiveness of doxycycline treatment in Cp-negative OAL has not been tested . METHODS In a prospect i ve trial , 27 OAL patients ( 15 newly diagnosed and 12 having experienced relapse ) were given a 3-week course of doxycycline therapy . Objective lymphoma response was assessed by computerized tomography scans or magnetic resonance imaging at 1 , 3 , and 6 months after the conclusion of therapy and every 6 months during follow-up . Cp infection in patients was determined by touchdown enzyme time-release polymerase chain reaction ( TETR-PCR ) . Statistical tests were two-sided . RESULTS Eleven patients were Cp DNA-positive and 16 were Cp DNA negative . Doxycycline was well tolerated . At a median follow-up of 14 months , lymphoma regression was complete in six patients , and a partial response ( > or = 50 % reduction of all measurable lesions ) was observed in seven patients ( overall response rate [ complete and partial responses ] = 48 % ) . Lymphoma regression was observed in both Cp DNA-positive patients ( seven of 11 experienced regression ) and Cp DNA-negative patients ( six of 16 experienced regression ) ( 64 % versus 38 % ; P = .25 , Fisher 's exact test ) . The three patients with regional lymphadenopathies and three of the five patients with bilateral disease achieved objective response . In relapsed patients , response was observed both in previously irradiated and nonirradiated patients . The 2-year failure-free survival rate among the doxycycline-treated patients was 66 % ( 95 % confidence interval = 54 to 78 ) , and 20 of the 27 patients were progression free . CONCLUSIONS Doxycycline is a fast , safe , and active therapy for Cp DNA-positive OAL that was effective even in patients with multiple failures involving previously irradiated areas or regional lymphadenopathies . The responses observed in PCR-negative OAL may suggest a need for development of more sensitive methods for Cp detection and investigation of the potential role of other doxycycline-sensitive bacteria PURPOSE To measure the genomic DNA of ocular infectious pathogens in ocular fluids and to analyze the clinical relevance of these pathogens in uveitis and endophthalmitis . DESIGN Prospect i ve clinical case series . PARTICIPANTS A total of 500 patients with infectious uveitis and endophthalmitis were examined at Tokyo Medical and Dental University , Tokyo Medical University , Kyushu University , Osaka University , and Kyoto Prefectural University , all in Japan . METHODS Genomic DNA of bacteria , fungi , parasites , and viruses in collected intraocular sample s were examined by comprehensive polymerase chain reaction ( PCR ) . Sample s were analyzed first by multiplex PCR and quantitative real-time PCR for human herpes viruses ( HHVs ) 1 through 8 and toxoplasma . Subsequently , sample s were examined by broad-range real-time PCR for bacterial 16S and fungal 18S/28S ribosomal DNA ( rDNA ) . MAIN OUTCOME MEASURES Infectious uveitis and endophthalmitis diagnoses were obtained when using the PCR system . Calculations of the positivity and the diagnostic parameters such as sensitivity , specificity , positive predictive value ( PPV ) , and negative predictive value ( NPV ) also were evaluated . RESULTS In all of the tested infectious uveitis and endophthalmitis patients , either herpes simplex virus type 1 ( n = 18 ) , herpes simplex virus type 2 ( n = 4 ) , varicella-zoster virus ( n = 55 ) , Epstein-Barr virus ( n = 17 ) , cytomegalovirus ( n = 68 ) , HHV type 6 ( n = 2 ) , toxoplasma ( n = 6 ) , bacterial 16S ( n = 33 ) , or fungal 18S/28S ( n = 11 ) genome was detected . Neither HHV type 7 nor HHV type 8 DNA was detected in any of the sample s. Of the 21 false-negative results found during the PCR analyses , 12 cases were negative for patients clinical ly suspected of having bacterial endophthalmitis . Conversely , false-positive results for the comprehensive PCR examinations occurred in only 3 cases that subsequently were found to have bacterial 16S rDNA . Diagnostic parameters for the sensitivity , specificity , PPV , and NPV of our PCR examinations were 91.3 % , 98.8 % , 98.6 % , and 92.4 % , respectively . CONCLUSIONS Use of our comprehensive PCR assay to examine ocular sample s in patients with endophthalmitis and uveitis seems to be clinical ly useful for detecting infectious antigen DNA . Thus , this PCR method is a reliable tool for both diagnosing ocular disorders and further screening of patients for intraocular infections . FINANCIAL DISCLOSURE(S ) The author(s ) have no proprietary or commercial interest in any material s discussed in this article PURPOSE The pathogenic association between Chlamydophila psittaci ( Cp ) and ocular adnexal marginal zone lymphoma ( OAMZL ) and the efficacy of doxycycline monotherapy have been investigated in retrospective series with variations in stage , management , and follow-up duration . To our knowledge , this is the first international phase II trial aim ed at clarifying Cp prevalence and activity of first-line doxycycline in a homogeneous series of consecutive patients with newly diagnosed stage I OAMZL . PATIENTS AND METHODS Forty-seven patients were registered . Tumor tissue , conjunctival swabs , and peripheral blood from 44 patients were assessed for seven Chlamydiaceae infections by three polymerase chain reaction protocol s. Thirty-four patients with measurable or parametrable disease were treated with doxycycline and assessed for chlamydial eradication and lymphoma response ( primary end point ) . RESULTS Cp DNA was detected in biopsies of 39 patients ( 89 % ) ; no other Chlamydiaceae were detected . Twenty-nine patients had Cp DNA in baseline swabs and /or blood sample s and were evaluable for chlamydial eradication , which was achieved in 14 patients ( 48 % ) . Lymphoma regression was complete in six patients and partial in 16 ( overall response rate , 65 % ; 95 % CI , 49 % to 81 % ) ; 11 had stable disease , and one had progressive disease . At a \n Output:\n " }, { "from": "agent", "value": "The involvement of C psittaci in OAL is highly variable , with the highest prevalence in Italy and Korea .\nChlamydia is associated with MALT histotype" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Alterations in circulating angiogenic cells ( CAC ) and endothelial progenitor cells ( EPC ) , known to contribute to endothelial repair , could explain the reversal of endothelial function in response to exercise training . Moreover , training-induced vascular remodeling might affect the acute response of EPC and CAC following a single exercise bout . We studied the impact of exercise training on CAC function and numbers of CD34+/KDR+ EPC in patients with chronic heart failure ( CHF ) and we assessed the effect of acute exercise on CAC and EPC in sedentary and trained patients . Twenty-one sedentary CHF patients underwent 6-month exercise training and were compared to a non-trained control group ( n = 17 ) and 10 healthy age-matched subjects . At baseline and follow-up , flow-mediated dilation was assessed and grade d exercise testing ( GXT ) was performed . Before and immediately after GXT , CAC migratory capacity was assessed in vitro and circulating CD34+/KDR+ EPC were quantified using flow cytometry . At baseline , CAC migration was significantly impaired in sedentary CHF patients but normalized acutely after GXT . Training corrected endothelial dysfunction , which coincided with a 77 % increase in CAC migration ( P = 0.0001 ) . Moreover , the GXT-induced improvement detected at baseline was no longer observed after training . Numbers of CD34+/KDR+ EPC increased following 6-month exercise training ( P = 0.021 ) , but were not affected by GXT , either prior or post-training . In conclusion , the present findings demonstrate for the first time that exercise training in CHF reverses CAC dysfunction and increases numbers of CD34+/KDR+ EPC , which is accompanied by improvement of peripheral endothelial function . The acute exercise-induced changes in CAC function wane with exercise training , suggesting that repetitive exercise bouts progressively lead to functional endothelial repair Background — Exercise training reduces the symptoms of chronic heart failure . Which exercise intensity yields maximal beneficial adaptations is controversial . Furthermore , the incidence of chronic heart failure increases with advanced age ; it has been reported that 88 % and 49 % of patients with a first diagnosis of chronic heart failure are > 65 and > 80 years old , respectively . Despite this , most previous studies have excluded patients with an age > 70 years . Our objective was to compare training programs with moderate versus high exercise intensity with regard to variables associated with cardiovascular function and prognosis in patients with postinfa rct ion heart failure . Methods and Results — Twenty-seven patients with stable postinfa rct ion heart failure who were undergoing optimal medical treatment , including & bgr;-blockers and angiotensin-converting enzyme inhibitors ( aged 75.5±11.1 years ; left ventricular [ LV ] ejection fraction 29 % ; & OV0312;o2peak 13 mL · kg−1 · min−1 ) were r and omized to either moderate continuous training ( 70 % of highest measured heart rate , ie , peak heart rate ) or aerobic interval training ( 95 % of peak heart rate ) 3 times per week for 12 weeks or to a control group that received st and ard advice regarding physical activity . & OV0312;o2peak increased more with aerobic interval training than moderate continuous training ( 46 % versus 14 % , P<0.001 ) and was associated with reverse LV remodeling . LV end-diastolic and end-systolic volumes declined with aerobic interval training only , by 18 % and 25 % , respectively ; LV ejection fraction increased 35 % , and pro-brain natriuretic peptide decreased 40 % . Improvement in brachial artery flow-mediated dilation ( endothelial function ) was greater with aerobic interval training , and mitochondrial function in lateral vastus muscle increased with aerobic interval training only . The MacNew global score for quality of life in cardiovascular disease increased in both exercise groups . No changes occurred in the control group . Conclusions — Exercise intensity was an important factor for reversing LV remodeling and improving aerobic capacity , endothelial function , and quality of life in patients with postinfa rct ion heart failure . These findings may have important implication s for exercise training in rehabilitation programs and future studies Introduction Physical fitness is an important prognostic factor in heart failure ( HF ) . To improve fitness , different types of exercise have been explored , with recent focus on high-intensity interval training ( HIT ) . We comprehensively compared effects of HIT versus continuous training ( CT ) in HF patients NYHA II-III on physical fitness , cardiovascular function and structure , and quality of life , and hypothesize that HIT leads to superior improvements compared to CT . Methods Twenty HF patients ( male : female 19:1 , 64±8 yrs , ejection fraction 38±6 % ) were allocated to 12-weeks of HIT ( 10 * 1-minute at 90 % maximal workload — alternated by 2.5 minutes at 30 % maximal workload ) or CT ( 30 minutes at 60–75 % of maximal workload ) . Before and after intervention , we examined physical fitness ( incremental cycling test ) , cardiac function and structure ( echocardiography ) , vascular function and structure ( ultrasound ) and quality of life ( SF-36 , Minnesota living with HF question naire ( MLHFQ ) ) . Results Training improved maximal workload , peak oxygen uptake ( VO2peak ) related to the predicted VO2peak , oxygen uptake at the anaerobic threshold , and maximal oxygen pulse ( all P<0.05 ) , whilst no differences were present between HIT and CT ( N.S. ) . We found no major changes in resting cardiovascular function and structure . SF-36 physical function score improved after training ( P<0.05 ) , whilst SF-36 total score and MLHFQ did not change after training ( N.S. ) . Conclusion Training induced significant improvements in parameters of physical fitness , although no evidence for superiority of HIT over CT was demonstrated . No major effect of training was found on cardiovascular structure and function or quality of life in HF patients NYHA II-III . Trial Registration Nederl and s Trial Register Background A reduction in number and function of endothelial progenitor cells ( EPCs ) occurs in both physiologic aging and chronic heart failure ( CHF ) . We assessed whether disease and aging have additive effects on EPCs or whether beneficial effects of exercise training are diminished in old age . Methods We r and omized 60 patients with stable CHF and 60 referent controls to a training or a control group . To detect possible aging effects we included subjects below 55 ( young ) and above 65 years ( older ) . Subjects in the training group exercised four times daily at 60 % to 70 % of VO2max for four weeks under supervision . At baseline and after the intervention the number and function of EPCs were assessed . Results As compared with young referent controls , older referent controls showed at baseline a reduced EPC number ( young : 190 ± 37 CD34/KDR positive cells/ml blood ; older : 131 ± 26 CD34/KDR positive cells/ml blood ; p < 0.05 ) and function ( young : 230 ± 41 migrated cells/1000 plated cells ; older : 185 ± 28 cells/1000 plated cells ; p < 0.05 ) . In young and older CHF patients EPC-number ( young : 85 ± 21 CD34/KDR positive cells/ml blood ; older : 78 ± 20 CD34/KDR positive cells/ml blood ) and EPC-function ( young : 113 ± 26 cells/1000 plated cells ; older : 120 ± 27 cells/1000 plated cells ) were impaired . As a result of exercise training , EPC function improved by 24 % in older referent controls ( p < 0.05 ) , while it remained unchanged in young training referent controls and controls respectively . In young and older patients with CHF four weeks of exercise training result ed in a significant improvement in EPC numbers and EPC function ( young : number + 66 % function + 43 % ; p < 0.05 ; older : number + 69 % function + 36 % ; p < 0.05 ) . These results were accompanied by a significant increase in flow mediated dilatation in the training groups of young/older CHF patients and in older referent controls . Conclusions Four weeks of exercise training are effective in improving EPC number and EPC function in CHF patients . These training effects were not impaired among older patients , emphasizing the potentials of rehabilitation interventions in a patient group where CHF has a high prevalence Introduction : Several established tools are available to assess study quality and reporting of r and omized controlled trials ; however , these tools were design ed with clinical intervention trials in mind . In exercise training intervention trials some of the traditional study quality criteria , such as participant or research er blinding , are extremely difficult to implement . Methods : We developed the Tool for the assEssment of Study qualiTy and reporting in EXercise ( TESTEX ) – a study quality and reporting assessment tool , design ed specifically for use in exercise training studies . Our tool is a 15-point scale ( 5 points for study quality and 10 points for reporting ) and addresses previously unmentioned quality assessment criteria specific to exercise training studies . Results : There were no systematic differences between the summated TESTEX scores of each observer [ H(2 ) = 0.392 , P = 0.822 ] . There was a significant association between the summated TESTEX scores of the three observers , with almost perfect agreement between observers 1 and 2 [ intra-class correlation coefficient ( ICC ) = 0.93 , 95 % confidence interval ( CI ) 0.82–0.97 , P < 0.001 ] , observers 1 and 3 ( ICC = 0.96 , 95 % CI 0.89–0.98 , P < 0.001 ) and observers 2 and 3 ( ICC = 0.91 , 95 % CI 0.75–0.96 , P < 0.001 ) . Conclusions : The TESTEX scale is a new , reliable tool , specific to exercise scientists , that facilitates a comprehensive review of exercise training trials Background —In stable coronary artery disease ( CAD ) , exercise training has well-documented positive effects on arterial endothelial function . NO derived from endothelial NO synthase ( eNOS ) is regarded as a protective factor against atherosclerosis . The aim of the present study was to investigate the effects of exercise training on the endothelial function in relation to the expression of eNOS and Akt-dependent eNOS phosphorylation in the left internal mammary artery ( LIMA ) of patients with stable CAD . Methods and Results —In 17 training patients ( T ) and 18 control patients ( C ) , endothelium-dependent vasodilation and average peak flow velocity ( APV ) in response to acetylcholine were measured invasively at study beginning and after 4 weeks in the LIMA . In LIMA tissue sample d during bypass surgery , eNOS expression and content of pospho-eNOS-Ser1177 , Akt , and phospho-Akt were determined by Western blot and quantitative reverse transcriptase – polymerase chain reaction . After exercise training , LIMA APV in response to acetylcholine was increased by 56±8 % ( from + 48±8 % at beginning to + 104±11 % after 4 weeks , P < 0.001 ) . Patients in T had a 2-fold higher eNOS protein expression ( T 1.0±0.7 versus C 0.5±0.3 arbitrary units , P < 0.05 ) and 4-fold higher eNOS Ser1177-phosphorylation levels in LIMA-endothelium ( 1.2±0.9 versus 0.3±0.2 arbitrary units , P < 0.01 ) . A linear correlation was confirmed between Akt phosphorylation and phospho-eNOS levels ( R = 0.80 , P < 0.05 ) and between phospho-eNOS and & Dgr ; APV ( R = 0.59 , P < 0.05 ) . Conclusions —Exercise training in stable CAD leads to an improved agonist-mediated endothelium-dependent vasodilatory capacity . The change in acetylcholine-induced vasodilatation was closely related to a shear stress – induced/Akt-dependent phosphorylation of eNOS on Ser1177 BACKGROUND The purpose of this study was to determine the effects of systemic exercise training on endothelium-mediated arteriolar vasodilation of the lower limb and its relation to exercise capacity in chronic heart failure ( CHF ) . Endothelial dysfunction is a key feature of CHF , contributing to increased peripheral vasoconstriction and impaired exercise capacity . Local h and grip exercise has previously been shown to enhance endothelium-dependent vasodilation in conduit and resistance vessels in CHF . METHODS AND RESULTS Twenty patients were prospect ively r and omized to a training group ( n=10 , left ventricular ejection fraction [ LVEF ] 24+/-4 % ) or a control group ( n=10 , LVEF 23+/-3 % ) . At baseline and after 6 months , peak flow velocity was measured in the left femoral artery using a Doppler wire ; vessel diameter was determined by quantitative angiography . Peripheral blood flow was calculated from average peak velocity ( APV ) and arterial cross-sectional area . After exercise training , nitroglycerin-induced endothelium-independent vasodilation remained unaltered ( 271 % versus 281 % , P = NS ) . Peripheral blood flow improved \n Output:\n " }, { "from": "agent", "value": "CONCLUSION Overall exercise training improved endothelial function , assessed via FMD , and endothelial progenitor cells in heart failure patients" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND : It is not known if combination therapy of epinephrine injection and multipolar electrocoagulation or hemoclips are a more efficient or effective treatment for patients with acute nonvariceal upper gastrointestinal ( GI ) bleeding . METHODS : Adult patients with active nonvariceal upper GI bleeding , a nonbleeding visible vessel , or after removal of an adherent clot findings of active bleeding or a visible vessel were studied . Patients were r and omized to either therapy and the outcomes were assessed at 30 days . RESULTS : Forty-seven patients were studied : 26 patients r and omized to hemoclips and 21 to combination therapy . There were 22 patients with active bleeding , 13 with a nonbleeding visible vessel , and 12 with an adherent clot . The median duration of endoscopic therapy was 17 min in the hemoclip group versus 20 min for the combination therapy , p= 0.29 . Primary hemostasis with successful initial control of bleeding occurred in 26 ( 100 % ) of 26 hemoclip patients and 20 ( 95.2 % ) of 21 combination therapy patients , p= 0.45 . The rebleeding rates were : 4 ( 15.4 % ) of 26 hemoclip patients versus 5 ( 23.8 % ) of 21 combination therapy patients , p= 0.49 . Overall , the length of hospital stay , units of blood transfused , surgery rates , and mortality were not different . CONCLUSIONS : In this prospect i ve , r and omized controlled trial of endoscopic hemoclips versus combination therapy in the nonvariceal upper GI bleeding , the efficiency , efficacy , and complications of the two treatment modalities were not significantly different AIM To define the optimal injection volume of epinephrine with high efficacy for hemostasis and low complication rate in patients with actively bleeding ulcers . METHODS This prospect i ve , r and omized , comparative trial was conducted in a medical center . A total of 228 patients with actively bleeding ulcers ( spurting or oozing ) were r and omly assigned to three groups with 20 , 30 and 40 mL endoscopic injections of an 1:10000 solution of epinephrine . The hemostatic effects and clinical outcomes were compared between the three groups . RESULTS There were no significant differences in all background variables between the three groups . Initial hemostasis was achieved in 97.4 % , 98.7 % and 100 % of patients respectively in the 20 , 30 and 40 mL epinephrine groups . There were no significant differences in the rate of initial hemostasis between the three groups . The rate of peptic ulcer perforation was significantly higher in the 40 mL epinephrine group than in the 20 and 30 mL epinephrine groups ( P < 0.05 ) . The rate of recurrent bleeding was significantly higher in the 20 mL epinephrine group ( 20.3 % ) than in the 30 ( 5.3 % ) and 40 mL ( 2.8 % ) epinephrine groups ( P < 0.01 ) . There were no significant differences in the rates of surgical intervention , the amount of transfusion requirements , the days of hospitalization , the deaths from bleeding and 30 d mortality between the three groups . The number of patients who developed epigastric pain due to endoscopic injection , was significantly higher in the 40 mL epinephrine group ( 51/76 ) than in the 20 ( 2/76 ) and 30 mL ( 5/76 ) epinephrine groups ( P < 0.001 ) . Significant elevation of systolic blood pressure after endoscopic injection was observed in the 40 mL epinephrine group ( P < 0.01 ) . Significant decreasing and normalization of pulse rates after endoscopic injections were observed in the 20 mL and 30 mL epinephrine groups ( P < 0.01 ) . CONCLUSION Injection of 30 mL diluted epinephrine ( 1:10000 ) can effectively prevent recurrent bleeding with a low rate of complications . The optimal injection volume of epinephrine for endoscopic treatment of an actively bleeding ulcer ( spurting or oozing ) is 30 Acute upper gastrointestinal bleeding is the commonest emergency managed by gastroenterologists . It has an incidence ranging from approximately 50 to 150 per 100 000 of the population each year , the incidence being highest in areas of the lowest socioeconomic status . An audit of patients admitted to hospital in the UK published in 1995 reported 11 % mortality in patients admitted to hospital because of bleeding and 33 % mortality in those who developed gastrointestinal bleeding while hospitalised for other reasons .1 Most deaths occur in elderly patients who have significant comorbidity and the majority are inevitable , despite improvements in medical and surgical expertise . Mortality is reported to be lower in specialist units2,3 and this is probably not related to technical developments but because of adherence to protocol s and guidelines . Thus guidelines do have the potential to improve prognosis and in addition may be of value in making the best use of re sources by fast tracking low risk patients , thereby optimising duration of hospital stay . “ Medline ” and “ EMBASE ” were search ed to identify the evidence used in formulating these guidelines . The term “ gastrointestinal hemorrhage ” was used to identify general review s , leading articles , meta-analyses , and r and omised clinical trials . Not all of the recommendations have been subjected to clinical trial but represent what , in the view of the British Society of Gastroenterology ( BSG ) endoscopy committee , defines best clinical practice . Guidelines can not replace clinical judgment in the management of any specific patient . Best management depends on close cooperation between medical and surgical gastroenterologists and “ combined care ” is essential in managing the critically ill bleeding patient . The specific management of acute variceal haemorrhage is a special subject and is not considered in detail . # # # 1.1 Grading of recommendations # # # # Grade A # # # # Grade B # # # # Grade Clip application is increasingly used in gastrointestinal endoscopy . Its safety and efficacy in the treatment of gastrointestinal bleeding has been demonstrated in r and omized controlled studies of peptic ulcer , Dieulafoy ’s lesion , and Mallory Weiss tear bleeding as well as case series of postpolypectomy and diverticular bleeding . In addition , the use of endoscopic clipping has been reported in the closure of mucosal defects such as perforations , anastomotic leaks , and fistulas ; the attachment of enteral tube and stent devices to the luminal wall ; and radiographic marking in order to direct fluoroscopic stent placement and target surgical , interventional radiologic or radiation therapy . In this article , we will focus on our technique of using endoscopic clipping for primary hemostasis in severe upper gastrointestinal bleeding BACKGROUND Treating patients of bleeding peptic ulcers with heater probe thermocoagulation and haemoclip is considered to be safe and very effective . Yet , there is no report comparing the haemostatic effects of endoscopic haemoclip versus heater probe thermocoagulation plus hypertonic saline-epinephrine injection in these patients . AIM To compare the clinical outcomes of both therapeutic modalities in patients with peptic ulcer bleeding . METHODS A total of 93 patients with active bleeding or non-bleeding visible vessels were r and omised to receive either endoscopic haemoclip ( n = 46 ) or heater probe thermocoagulation plus hypertonic saline-epinephrine injection ( n = 47 ) . Five patients from the haemoclip group were excluded because of the inability to place the haemoclip . RESULTS Initial haemostasis was achieved in 39 patients ( 95.1 % ) of the haemoclip group and 47 patients ( 100 % ) of the heater probe group ( P > 0.1 ) . Rebleeding occurred in four patients ( 10.3 % ) of the haemoclip group and three patients ( 6.4 % ) of the heater probe group ( P > 0.1 ) . The volume of blood transfused after entry into the study , duration of hospital stay , number of patients requiring urgent surgery and the mortality rates were not statistically different between the two groups . CONCLUSIONS If the haemoclip can be applied properly , the clinical outcomes of the haemoclip group would be similar to those of the heater probe group in patients with peptic ulcer bleeding . However , if the bleeders are located at the difficult-to-approach sites , heater probe plus hypertonic saline injection is the first choice therapy BACKGROUND Effective hemostatic treatment is m and atory for patients with actively bleeding Mallory-Weiss syndrome . This study evaluated the respective efficacy and the safety of endoscopic b and ligation and endoscopic epinephrine injection in Mallory-Weiss syndrome . METHODS Thirty-four consecutive patients with actively bleeding Mallory-Weiss syndrome were prospect ively enrolled and were r and omly assigned to undergo endoscopic b and ligation or endoscopic injections of a 1:10,000 solution of epinephrine . Demographic characteristics , endoscopic variables , and outcome parameters , including rates of hemostasis and recurrent bleeding , were analyzed . RESULTS The number of elastic b and s applied was one or two ; the mean volume of epinephrine injected was 18.0 mL : 95 % CI[16.8 , 19.2 ] . There was no significant difference between the groups with respect to age , gender , alcohol ingestion , presenting symptoms , Hb level , shock , comorbid diseases , coagulopathy , tear location , blood transfusion , or duration of hospitalization . Primary hemostasis was achieved in all 17 patients in the b and ligation group and in 16 of 17 patients ( 94.1 % ) in the epinephrine injection group . There was no recurrence of bleeding or major complication in either group . CONCLUSIONS In this small study , no difference was detected in the efficacy or the safety of b and ligation vs. epinephrine injection for the treatment of actively bleeding Mallory-Weiss syndrome BACKGROUND Endoscopic application of hemoclips ( HC ) was prospect ively compared with heat probe ( HP ) treatment in patients with bleeding ulcers . METHODS One hundred thirteen patients with major stigmata of ulcer hemorrhage were r and omly assigned to receive HP ( n = 57 ) or HC ( n = 56 ) . Clinical and endoscopic features were comparable in both groups . Recurrent bleeding was retreated with the modality previously used . Patients in whom treatment or retreatment was unsuccessful underwent emergency surgery . RESULTS Hemostasis , adequate treatment of visible vessel , 30-day mortality , and emergency surgery rates were similar for both groups . Recurrent bleeding was 21 % for HP and 1.8 % for HC ( p < 0.05 ) . Length of hospital stay and transfusion requirements were significantly lower in the HC group . There was no evidence of clip-induced tissue injury or impaired ulcer healing . Clips dislodged spontaneously in most patients within 8 weeks of treatment . No further hemorrhage occurred on a median follow-up of 11 months ( range 1 - 23 ) . CONCLUSIONS The hemoclip is safe and effective in the treatment of severe ulcer bleeding and is superior to HP in preventing early recurrent bleeding BACKGROUND AND STUDY AIMS The endoscopic hemostatic method has been introduced as a safe and effective mechanical approach to hemostasis for upper gastrointestinal bleeding related to Mallory-Weiss syndrome ( MWS ) . However , the indications for when to use endoscopic treatment are debatable because many patients need only medical observation . The study was design ed to evaluate the necessity and efficacy of endoscopic hemostasis in upper gastrointestinal bleeding related to MWS . PATIENTS AND METHODS From July 1994 to May 2000 , we conducted a clinical trial in 76 patients who were found by endoscopy to have active bleeding ( I , spurting ; II , oozing ) , protruding visible vessels ( III ) , and /or adherent clots ( IV ) . Two study periods can be differentiated : in the first 3 years endoscopic treatment ( n = 30 ) was prospect ively analyzed and in the final 3 years medical treatment ( n = 46 ) was analyzed in both cases to compare the outcome in MWS bleeding II-IV . In the first study period , in addition , endoscopic treatment was r and omised to an injection method , using a mixture of hypertonic saline and epinephrine ( HSE ) ( n = 14 ) and a hemoclipping or b and ligation method ( n = 16 ) . RESULTS Rebleeding was observed in four of 14 patients who had received endoscopic hemostasis with HSE injection and one of 46 patients who had been managed with medical treatment . No rebleeding was found following hemoclipping or b and ligation . While all rebleeding was in bleeding stigmata of the I ( 1 ) and II ( 4 ) grade s , there was no rebleeding in protruding visible vessels ( III ) or in adherent clots ( IV ) , regardless of treatment methods . CONCLUSIONS Our results suggested that endoscopic hemostasis is not necessary in patients without active bleeding stigmata , and the mechanical hemostatic method is more effective than HSE injection in patients with active bleeding stigmata BACKGROUND / AIMS The use of hemostatic clips is conceptually attractive for achieving definitive hemostasis in peptic ul \n Output:\n " }, { "from": "agent", "value": "Current evidence suggests that the hemoclip is not superior to other endoscopic modalities in terms of initial hemostasis , rebleeding rate , emergency surgery , and the mortality rate for treatment of PUB" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background — Persons of lower socioeconomic status have greater cardiovascular risk than those of higher socioeconomic status . However , the mechanism through which socioeconomic status affects cardiovascular disease ( CVD ) is uncertain . Virtually no data are available that examine the prospect i ve association between novel inflammatory and hemostatic CVD risk indicators , socioeconomic status , and incident CVD events . Methods and Results — We assessed the relationship between 2 indicators of socioeconomic status ( education and income ) , traditional and novel CVD risk factors ( high sensitivity C-reactive protein , soluble intercellular adhesion molecule-1 , fibrinogen , and homocysteine ) , and incident CVD events among 22 688 apparently healthy female health professionals participating in the Women 's Health Study . These women were followed up for 10 years for the development of myocardial infa rct ion , ischemic stroke , coronary revascularization , and cardiovascular death . More educated women were less likely to be smokers ; had a lower prevalence of hypertension , diabetes , and obesity ; and were more likely to participate in vigorous physical activity than less educated women . At baseline , median total cholesterol , low-density lipoprotein , triglyceride , C-reactive protein , intercellular adhesion molecule-1 , fibrinogen , and homocysteine levels for women in 5 categories of education ( < 2 years of nursing education , 2 to < 4 years of nursing education , a bachelor 's degree , a master 's degree , and a doctoral degree ) and 6 categories of income [ ≤$19 999 , $ 20 000 to $ 29 999 , $ 30 000 to $ 39 999 , $ 40 000 to $ 49 999 , $ 50 000 to $ 99 999 , and ≥$100 000 ) decreased progressively with increasing education or income levels ( all P<0.001 ) , whereas an opposite pattern was observed for high-density lipoprotein ( P<0.001 ) . Overall , in age-adjusted Cox proportional hazards models , the relative risk of incident CVD events decreased with increasing education ( 1.0 , 0.7 , 0.5 , 0.4 , and 0.5 ; P for trend < 0.001 ) and income ( 1.0 , 1.0 , 0.9 , 0.7 , 0.6 , and 0.4 ; P for trend < 0.001 ) categories . In multivariate models that assessed the impact of traditional and novel CVD risk factors on the relationship between education/income and CVD events , the relative hazard of incident CVD associated with a 1-category-higher level of education changed from 0.79 in age- and race-adjusted analysis to 0.89 in fully adjusted analysis . The 11 % lower risk per 1 category of education remained significant ( P for trend=0.006 ) , suggesting that controlling for both novel and traditional risk factors could not explain the protective effect of education . A similar analysis for income revealed that its relationship with CVD events was explained largely by these noted risk factors . Conclusions — In this prospect i ve analysis , we observed a decrease in incident CVD events with increasing levels of education and income . In contrast to the relationship between income and CVD events , the relationship of CVD events with education was explained only partially by traditional and novel risk factors for CVD Importance Increased left ventricular ( LV ) mass and diastolic dysfunction are associated with cardiovascular disease . Prospect i ve data on effects of childhood socioeconomic status ( SES ) on measures of LV structure and function are lacking . Objective To examine whether family SES in childhood was associated with LV mass and diastolic function after adjustment for conventional cardiovascular disease risk factors in childhood and adulthood . Design , Setting , and Participants The analyses were performed in 2016 using data gathered in 1980 and 2011 within the longitudinal population -based Cardiovascular Risk in Young Finns Study . The sample comprised 1871 participants who reported family SES at ages 3 to 18 years and were evaluated for LV structure and function 31 years later . Exposures Socioeconomic status was characterized as annual income of the family and classified on a 3-point scale . Main Outcomes and Measures Left ventricular mass indexed according to height at the allometric power of 2.7 and the E/e′ ratio describing LV diastolic performance at ages 34 to 49 years . Results The participants were aged 3 to 18 years at baseline ( mean [ SD ] , 10.8 [ 5.0 ] years ) , and the length of follow-up was 31 years . Family SES was inversely associated with LV mass ( mean [ SD ] LV mass index , 31.8 [ 6.7 ] , 31.0 [ 6.6 ] , and 30.1 [ 6.4 ] g/m2.7 in the low , medium , and high SES groups , respectively ; differences [ 95 % CI ] , 1.7 [ 0.6 to 2.8 ] for low vs high SES ; 0.8 [ −0.3 to 1.9 ] for low vs medium ; and 0.9 [ 0.1 to 1.6 ] for medium vs high ; overall P = .001 ) and E/e′ ratio ( mean [ SD ] E/e′ ratio , 5.0 [ 1.0 ] , 4.9 [ 1.0 ] , and 4.7 [ 1.0 ] in the low , medium , and high SES groups , respectively ; differences [ 95 % CI ] , 0.3 [ 0.1 to 0.4 ] for low vs high SES ; 0.1 [ −0.1 to 0.3 ] for low vs medium ; and 0.2 [ 0 to 0.3 ] for medium vs high ; overall P < .001 ) in adulthood . After adjustment for age , sex , and conventional cardiovascular disease risk factors in childhood and adulthood , and participants ’ own SES in adulthood , the relationship with LV mass ( differences [ 95 % CI ] , 1.5 [ 0.2 to 2.8 ] for low vs high SES ; 1.3 [ 0 to 2.6 ] for low vs medium ; and 0.2 [ −0.6 to 1.0 ] for medium vs high ; P = .03 ) and E/e′ ratio ( differences [ 95 % CI ] , 0.2 [ 0 to 0.5 ] for low vs high SES ; 0.1 [ −0.1 to 0.4 ] for low vs medium ; and 0.1 [ 0 to 0.3 ] for medium vs high ; P = .02 ) remained significant . Conclusions and Relevance Low family SES was associated with increased LV mass and impaired diastolic performance more than 3 decades later . These findings emphasize that approaches of cardiovascular disease prevention must be directed also to the family environment of the developing child BACKGROUND The incidence of congestive heart failure ( CHF ) has been increasing steadily in the United States during the past 2 decades . We studied risk factors for CHF and their corresponding attributable risk in the First National Health and Nutrition Examination Survey Epidemiologic Follow-up Study . PARTICIPANTS AND METHODS A total of 13 643 men and women without a history of CHF at baseline examination were included in this prospect i ve cohort study . Risk factors were measured using st and ard methods between 1971 and 1975 . Incidence of CHF was assessed using medical records and death certificates obtained between 1982 and 1984 and in 1986 , 1987 , and 1992 . RESULTS During average follow-up of 19 years , 1382 CHF cases were documented . Incidence of CHF was positively and significantly associated with male sex ( relative risk [ RR ] , 1.24 ; 95 % confidence interval [ CI ] , 1.10 - 1.39 ; P<.001 ; population attributable risk [ PAR ] , 8.9 % ) , less than a high school education ( RR , 1.22 ; 95 % CI , 1.04 - 1.42 ; P = .01 ; PAR , 8.9 % ) , low physical activity ( RR , 1.23 ; 95 % CI , 1.09 - 1.38 ; P<.001 ; PAR , 9.2 % ) , cigarette smoking ( RR , 1.59 ; 95 % CI , 1.39 - 1.83 ; P<.001 ; PAR , 17.1 % ) , overweight ( RR , 1.30 ; 95 % CI , 1.12 - 1.52 ; P = .001 ; PAR , 8.0 % ) , hypertension ( RR , 1.40 ; 95 % CI , 1.24 - 1.59 ; P<.001 ; PAR , 10.1 % ) , diabetes ( RR , 1.85 ; 95 % CI , 1.51 - 2.28 ; P<.001 ; PAR , 3.1 % ) , valvular heart disease ( RR , 1.46 ; 95 % CI , 1.17 - 1.82 ; P = .001 ; PAR , 2.2 % ) , and coronary heart disease ( RR , 8.11 ; 95 % CI , 6.95 - 9.46 ; P<.001 ; PAR , 61.6 % ) . CONCLUSIONS Male sex , less education , physical inactivity , cigarette smoking , overweight , diabetes , hypertension , valvular heart disease , and coronary heart disease are all independent risk factors for CHF . More than 60 % of the CHF that occurs in the US general population might be attributable to coronary heart disease Objective To investigate the association between low functional health literacy ( ability to read and underst and basic health related information ) and mortality in older adults . Design Population based longitudinal cohort study based on a stratified r and om sample of households . Setting Engl and . Participants 7857 adults aged 52 or more who participated in the second wave ( 2004 - 5 ) of the English Longitudinal Study of Ageing and survived more than 12 months after interview . Participants completed a brief four item test of functional health literacy , which assessed underst and ing of written instructions for taking an aspirin tablet . Main outcome measure Time to death , based on all cause mortality through October 2009 . Results Health literacy was categorised as high ( maximum score , 67.2 % ) , medium ( one error , 20.3 % ) , or low ( more than one error , 12.5 % ) . During follow-up ( mean 5.3 years ) 621 deaths occurred : 321 ( 6.1 % ) in the high health literacy category , 143 ( 9.0 % ) in the medium category , and 157 ( 16.0 % ) in the low category . After adjusting for personal characteristics , socioeconomic position , baseline health , and health behaviours , the hazard ratio for all cause mortality for participants with low health literacy was 1.40 ( 95 % confidence interval 1.15 to 1.72 ) and with medium health literacy was 1.15 ( 0.94 to 1.41 ) compared with participants with high health literacy . Further adjustment for cognitive ability reduced the hazard ratio for low health literacy to 1.26 ( 1.02 to 1.55 ) . Conclusions A third of older adults in Engl and have difficulties reading and underst and ing basic health related written information . Poorer underst and ing is associated with higher mortality . The limited health literacy capabilities within this population have implication s for the design and delivery of health related services for older adults in Engl and A process to identify and target a selected population at risk of heart failure ( HF ) could facilitate screening and prevention . We sought to develop an effective screening process from clinical characteristics , functional capacity , and electrocardiogram ( ECG ) . Asymptomatic subjects ≥65 years , with ≥1 HF risks were recruited from the community . Subjects with valvular disease , ejection fraction < 40 % , and atrial fibrillation were excluded . All underwent clinical evaluation including assessment of HF risk using Framingham HF score and Atherosclerosis Risk in Communities ( ARIC ) score , ECG , echocardiography , and 6-minute walk ( 6 MW ) test . After 14 ± 4 months , new HF was assessed using Framingham criteria . A r and omly selected derivation cohort was used to integrate ARIC score and 6 MW in a classification and regression tree ( CART ) analysis , with the remaining population used for validation . Of the 419 subjects ( age 70 ± 5 ; 48 % men ) , 52 developed HF . ARIC was more effective than the Framingham HF score ( area under the curve 0.65 vs 0.53 , p = 0.01 ) . CART selected ARIC ( > 9.5 % ) and 6 MW ( < 501 m ) as cutoffs to define low- , intermediate- , and high-risk groups . Abnormal ECG further divided the intermediate group into high and low risks . The 134 subjects identified as high risk by a combined clinical and electrocardiographic strategy showed more echocardiographic features of cardiac dysfunction including LV mass , mitral e ' , mitral E/e ' , and longitudinal strain ( p < 0.01 ) . New HF was significantly more frequent than in the remaining \n Output:\n " }, { "from": "agent", "value": "Low SES assessed by all common measures confers independent risk for incident HF ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective : To investigate the effect of two contrasting physical activity worksite interventions versus a reference intervention ( REF ) on various health outcomes . Methods : A 1-year r and omized controlled trial was conducted with specific resistance training ( SRT ) , all-round physical exercise ( APE ) , and REF . Results : SRT and APE compared with REF showed significant reductions in systolic blood pressure ( ∼6 mm Hg ) , body fat percentage ( ∼2.2 body fat% ) , as well as shoulder and back pain ( ∼30 % reduction in duration ) . Muscle strength ( APE and SRT ) and maximal oxygen uptake ( APE ) increased approximately 10 % . Conclusions : Worksite intervention with both SRT as well as APE is recommended , since these activities compared with REF result ed in clinical ly relevant reductions of cardiovascular and metabolic syndrome-related risk factors as well as musculoskeletal pain symptoms , in combination with minor increases in physical capacity Purpose of review This review highlights recent work evaluating the relationship between exercise , physical activity and physical and mental health . Both cross-sectional and longitudinal studies , as well as r and omized clinical trials , are included . Special attention is given to physical conditions , including obesity , cancer , cardiovascular disease and sexual dysfunction . Furthermore , studies relating physical activity to depression and other mood states are review ed . The studies include diverse ethnic population s , including men and women , as well as several age groups ( e.g. adolescents , middle-aged and older adults ) . Recent findings Results of the studies continue to support a growing literature suggesting that exercise , physical activity and physical-activity interventions have beneficial effects across several physical and mental-health outcomes . Generally , participants engaging in regular physical activity display more desirable health outcomes across a variety of physical conditions . Similarly , participants in r and omized clinical trials of physical-activity interventions show better health outcomes , including better general and health-related quality of life , better functional capacity and better mood states . Summary The studies have several implication s for clinical practice and research . Most work suggests that exercise and physical activity are associated with better quality of life and health outcomes . Therefore , assessment and promotion of exercise and physical activity may be beneficial in achieving desired benefits across several population s. Several limitations were noted , particularly in research involving r and omized clinical trials . These trials tend to involve limited sample sizes with short follow-up periods , thus limiting the clinical implication s of the benefits associated with physical activity . Abbreviations CAD : coronary artery disease ; COPD : chronic obstructive pulmonary disease ; CRP : cardiac rehabilitation program ; CVD : cardiovascular disease ; GMCB : group-mediated cognitive – behavioural ; HRQOL : health-related quality of life Objectives : To determine the effects of sporting activity on absenteeism in a working population . Methods : Data were used from a prospect i ve cohort study in a working population with a follow up period of 3 years and were collected with yearly question naires or collected from company records . Complete data on absenteeism , sporting activity , and potential confounders were collected for 1228 workers . ANOVA was used to test differences in frequency and duration of absenteeism , correlations were computed to measure the association between number of sporting years ( divided by age ) and frequency and duration of absenteeism , and survival analysis , according to the Cox proportional hazards model , was used to test differences in relative risk at absenteeism and recovery . All analyses were adjusted for age , gender , smoking , and alcohol consumption , and were stratified for employees with sedentary and with more active jobs . Results : ANOVA showed a statistically significant higher mean duration of absenteeism among employees not practicing sports , of approximately 20 days over a period of 4 years . The survival analysis showed an increased relative risk at absenteeism ( relative risk ( RR ) 1.09 ; confidence interval ( CI ) 1.01 to 1.18 ) and a decreased relative risk at recovery ( RR 0.90 ; CI 0.85 to 0.95 ) for employees not practicing sports . The effect of sporting activity is larger in employees with sedentary work . No associations were found between number of sporting years and absenteeism . Conclusion : Employees practicing sports take sick leave significantly less often than their colleagues not practicing sports , while their periods of sick leave are shorter , especially when their work is sedentary Highly stressed employees are subject to greater health risks , increased cost , and productivity losses than those with normal stress levels . To address this issue in an evidence -based manner , worksite stress management programs must be able to engage individuals as well as capture data on stress , health indices , work productivity , and health care costs . In this r and omized controlled pilot , our primary objective was to evaluate the viability and proof of concept for two mind-body workplace stress reduction programs ( one therapeutic yoga-based and the other mindfulness-based ) , in order to set the stage for larger cost-effectiveness trials . A second objective was to evaluate 2 delivery venues of the mindfulness-based intervention ( online vs. in-person ) . Intention-to-treat principles and 2 ( pre and post ) × 3 ( group ) repeated- measures analysis of covariance procedures examined group differences over time on perceived stress and secondary measures to clarify which variables to include in future studies : sleep quality , mood , pain levels , work productivity , mindfulness , blood pressure , breathing rate , and heart rate variability ( a measure of autonomic balance ) . Two hundred and thirty-nine employee volunteers were r and omized into a therapeutic yoga worksite stress reduction program , 1 of 2 mindfulness-based programs , or a control group that participated only in assessment . Compared with the control group , the mind-body interventions showed significantly greater improvements on perceived stress , sleep quality , and the heart rhythm coherence ratio of heart rate variability . The two delivery venues for the mindfulness program produced basically equivalent results . Both the mindfulness-based and therapeutic yoga programs may provide viable and effective interventions to target high stress levels , sleep quality , and autonomic balance in employees Integrating organizationally targeted wellness strategies into the routine conduct of business has shown promise in engaging captive audiences at highest risk of obesity and obesity-related health consequences . This paper presents a process evaluation of the implementation of the University of California , Los Angeles , Working Out Regularly Keeps Individuals Nurtured and Going ( WORKING ) pilot study . WORKING focuses on integrating physical activity and nutrition practice s into workplace routine during non-discretionary paid work time . The purpose of the evaluation was to assess the quality of implementation and to underst and factors that facilitated or hindered organizations ' full uptake of the intervention . Fifteen worksites were r and omly assigned to an intervention condition . Qualitative data were gathered through routine site visits and informant interviews conducted throughout each worksite 's intervention period . Worksites were classified into one of four implementation success categories based on their level of adoption and maintenance of core intervention strategies . Six key factors emerged that were related to implementation success : site layout and social climate , wellness infrastructure , number and influence of Program Champions , leadership involvement , site innovation and creativity . This pilot study has informed the conduct of WORKING II ; a cluster r and omized controlled trial aim ed at enrolling 60 - 70 worksites in Los Angeles County Background Only a few workplace initiatives among cleaners have been reported , even though they constitute a job group in great need of health promotion . The purpose of this trial was to evaluate the effect of either physical coordination training or cognitive behavioural training on musculoskeletal pain , work ability and sickness absence among cleaners . Methods A cluster-r and omised controlled trial was conducted among 294 female cleaners allocated to either physical coordination training ( PCT ) , cognitive behavioural training ( CBTr ) or a reference group ( REF ) . Question naires about musculoskeletal pain and work ability were completed at baseline and after one year 's intervention . Sickness absence data were obtained from the managers ' records . Analyses were performed according to the intention-to-treat-principle ( ITT ) . Results No overall reduction in musculoskeletal pain , work ability or sickness absence from either PCT or CBTr compared with REF was found in conservative ITT analyses . However , explorative analyses revealed a treatment effect for musculoskeletal pain of the PCT . People with chronic neck/shoulder pain at baseline were more frequently non-chronic at follow-up after PCT compared with REF ( p = 0.05 ) . Conclusions The PCT intervention appeared effective for reducing chronic neck/shoulder pain among the female cleaners . It is recommended that future interventions among similar high-risk job groups focus on the implementation aspects of the interventions to maximise outcomes more distal from the intervention such as work ability and sickness absence . Trial registration IS RCT N : IS RCT Objective .The objective of this work was to develop a psychometrically sound question naire for measuring the on-the-job impact of chronic health problems and /or treatment ( “ work limitations ” ) . Research Design .Three pilot studies ( focus groups , cognitive interviews , and an alternate forms test ) generated c and i date items , dimensions , and response scales . Two field trials tested the psychometric performance of the question naire ( studies 1 and 2 ) . To test recall error , study 1 subjects were r and omly assigned to 2 different question naire groups , a question naire with a 4-week reporting period completed once or a 2-week version completed twice . Responses were compared with data from concurrent work limitation diaries ( the gold st and ard ) . To test construct validity , we compared question naire scores of patients with those of healthy job-matched control subjects . Study 2 was a cross-sectional mail survey testing scale reliability and construct validity . Subjects . The study subjects were employed individuals ( 18–64 years of age ) from several chronic condition groups ( study 1 , n = 48 ; study 2 , n = 121 ) and , in study 1 , 17 healthy matched control subjects . Measures . Study 1 included the assigned question naires and weekly diaries . Study 2 included the new question naire , SF-36 , and work productivity loss items . Results .In study 1 , question naire responses were consistent with diary data but were most highly correlated with the most recent week . Patients had significantly higher ( worse ) limitation scores than control subjects . In study 2 , 4 scales from a 25-item question naire achieved Cronbach alphas of ≥0.90 and correlated with health status and self-reported work productivity in the hypothesized manner ( P ≤0.05 ) . Conclusions .With 25 items , 4 dimensions ( limitations h and ling time , physical , mental-interpersonal , and output dem and s ) , and a 2-week reporting period , the Work Limitations Question naire demonstrated high reliability and validity Background Whether the association of alcohol consumption and cardiovascular disease is the product of confounding and the degree to which this concern applies to other behaviors are unclear . Methods Using the 2003 Behavioral Risk Factor Surveillance System , a population -based telephone survey of adults in the US , we compared chronic disease risk factors between 123,359 abstainers and 126,674 moderate drinkers , defined as intake of ≤ 2 drinks per day among men and ≤ 1 drink per day among women , using age- and sex- and multivariable-adjusted models . We also compared sedentary and active individuals , defined as moderate physical activity ≥ 30 minutes per day for ≥ 5 days per week , or vigorous activity for ≥ 20 minutes per day on ≥ 3 days . Results Chronic disease risk factors and features of unhealthy lifestyle were generally more prevalent among abstainers than drinkers in age- and sex-adjusted analyses , but these differences were generally attenuated or eliminated by additional adjustment for race and education . For low fruit and vegetable intake , divorced marital status , and absence of a personal physician , adjustment for race and education reversed initially positive age- and sex-adjusted associations with abstention . Comparison of sedentary and active individuals produced similar findings , with generally lower levels of risk factors among more physical active individuals . Conclusion The differences between abstainers and drinkers are attenuated after adjustment for limited sociodemographic features , and sedentary and active individuals share a similar pattern . Although observational studies of both factors may be susceptible to uncontrolled confounding , our results provide no evidence that moderate drinking is unique in this regard . Ultimately , r and omized trials of all such lifestyle factors will be needed to answer these questions definitively AIM This paper is the report of a pilot study to assess if an Integrated Health Programme would reduce sick leave and subjective health complaints , and increase coping in a population of nursing personnel . BACKGROUND . The work group in Norway with most sick leave is healthcare workers . More than 50 % of the sick leave is because of subjective health complaints . Work place physical exercise interventions have a documented positive effect on sick leave . METHOD After baseline screening , employees who had agreed to participate ( n=40 ) were r and omized to an intervention or control group . The intervention group participated in an Integrated Health Programme twice weekly during working hours . The programme consisted of physical exercise , stress management training , health information and an examination of the participants ' workplace . The control group was offered the same intervention after the project was finished . This study was carried out from 2001 to 2002 . FINDINGS There were no statistically significant effects on sick leave or health-related quality of life . The intervention group reported fewer neck complaints compared to the control group , but otherwise there were no effects on subjective health complaints . However , the subjective effects were large and highly statistically significant , the intervention group reporting improvement in health , physical fitness , muscle pain , stress management , maintenance of health and work situation . CONCLUSION The Integrated Health Programme was not effective in reducing sick leave and subjective health complaints , but may be of use to employers wanting to increase employee job satisfaction and well-being BACKGROUND It is a common belief that physical exercise at the workplace decreases subjective health complaints and reduces sickness absence , but this is not supported by previous r and omized studies . AIMS To evaluate the effectiveness of physical exercise at the workplace . METHODS One hundred and \n Output:\n " }, { "from": "agent", "value": "There is consistent evidence that onsite workplace HEPA programmes do not reduce levels of sick leave .\nThere is inconsistent evidence that onsite workplace HEPA programmes improve self-reported worker productivity ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: It has previously been shown that unproductive coughing in both healthy subjects and patients with airways obstruction is not effective in clearing lung secretions . This study investigates the regional mucus transport in a group of subjects with airways obstruction who failed to expectorate following instructed cough and forced expiration technique . Fourteen patients ( mean + /- SEM age : 68 + /- 2 years ) with airways obstruction ( mean + /- SEM percent predicted . FEV1 : 54 + /- 5 ; daily wet weight sputum : 9.1 + /- 2.0 g ) took part in the study which was a r and omized , three-way crossover within-patient design . Each patient underwent three treatment maneuvers : control , cough ( 30 coughs over a 10-min period ) , and forced expiration ( 30 forced expirations over a 10-min period ) . An objective radioaerosol technique was used to monitor regional mucus movement within the lungs of the patients . The lungs were divided arbitrarily into four regions of interest : tracheal , inner , intermediate , and outer . Peak expiratory flow rate during cough and forced expiration was measured at the mouth . There was no correlation between the radioaerosol clearance from all regions and ( 1 ) mean peak flow during cough and forced expiration , and ( 2 ) mean 24-h sputum production prior to the study day . There were no differences in regional radioaerosol clearance between cough and forced expiration . However , both cough and forced expiration result ed in significant clearance compared with control for all regions with the exception of the forced expiration in the outer region . To our knowledge , this study is the first to demonstrate that unproductive cough and forced expiration result in movement of secretions proximally from all regions of the lung in patients with airways obstruction Eight patients with Young 's syndrome were treated with four \" mucoregulatory \" agents for eight weeks in a r and omised , open crossover study . There was no improvement in tracheobronchial clearance , pulmonary function , or sperm count The effectiveness of bromhexine in the treatment of patients with bronchiectasis , in a stage of clinical exacerbation , was assessed in a double-blind , placebo-controlled trial involving 88 in- patients . Bronchiectasis was diagnosed by bronchography and /or CT scan . Bromhexine or matched placebo was administered as 30-mg capsules three times daily per os . Ceftazidine , 1 g i.m . , was given to all patients once a day for the first week only . Bromhexine seemed to improve the clinical picture , with significantly positive trends for expectoration , quantity of sputum and auscultatory findings . It also increased the FEV1 and was well-tolerated . Both patients and investigators judged it efficacious BACKGROUND --In vitro studies have suggested that both the viscoelastic properties of lung secretions and the peak flow attained during simulated cough influence clearance . This study examines the possible association of the viscoelastic properties of sputum and maximum expiratory flow with measured effectiveness of mucus clearance induced by instructed cough and by forced expiration technique ( FET ) in patients with airways obstruction . METHODS --Nineteen patients ( 11 men and eight women ) of mean ( SE ) age , % predicted FEV1 , and daily sputum wet weight of 64 ( 2 ) years , 52 (6)% , and 37.5 ( 7.9 ) g respectively participated in the study . Mucus movement from proximal and peripheral lung regions was measured by an objective non-invasive radioaerosol technique . Each patient underwent three assessment s : control , cough , and FET . During cough and FET , maximum expiratory flow was measured at the mouth level . Apparent viscosity and elasticity of the expectorated sputum sample s were measured with a viscometer . RESULTS --Compared with the control run ( mean ( SE ) clearance : 16 (3)% ) there was an increase in clearance from the whole lung during cough ( 44 (5)% ) and FET ( 42 (5)% ) , and also an enhanced clearance of inhaled , deposited radioaerosol from the trachea , inner and intermediate regions of the lungs , but not from the outer region . There were , however , no differences in regional clearance between cough and FET . Neither regional nor total clearance correlated with maximum expiratory flow , apparent viscosity , elasticity , or daily sputum wet weight . CONCLUSIONS --These results confirm that cough and FET both promote effective clearance but suggest that , unlike in vitro studies , sputum production and viscoelasticity , as well as maximum expiratory flow , provide no guide to clearance efficacy in humans The authors report the results of a study design ed to evaluate the possible increase of penetration into bronchial secretions of antibiotics when combined with a fluidifying agent : bromhexine . The study was carried out in a double-blind experiment : erythromycin in 22 patients ( group I ) or amoxycillin in 26 patients ( group II ) were administered orally ; in both groups several patients were given a placebo , instead of bromhexine . Antibiotics were administered at the usual dosage : 0.5 g X 2 for erythromycin ( 3 days ) ; 1 g X 2 for amoxycillin ( 7 days ) ; with the latter , two different doses of bromhexine were administered simultaneously : 48 mg/day and 96 mg/day in ten and eight patients respectively . Sample s of bronchial secretions were collected by means of fibreoptic bronchoscopy at the second hour for erythromycin and for amoxycillin ; simultaneous serum sample s were also collected . The results of the study showed in both groups a significant increase of the ratios between bronchial levels and simultaneous serum concentrations when combined with bromhexine ; in patients receiving amoxycillin with 96 mg of bromhexine the percentage penetration was noticeably higher ( 7.5 % ) than in those treated with 48 mg bromhexine ( 4.3 % ) . These results confirm the efficacy of bromhexine as a drug able to disrupt mucopolysaccharides of bronchial secretions and , as a result , to increase the bronchial penetration of antimicrobial drugs as evaluated on the basis of percentage penetration ratio The effect of peroral N-acetylcysteine ( NAC ) in patients with cystic fibrosis ( CF ) and primary ciliary dyskinesia ( PCD ) was investigated . 41 CF patients and 13 PCD patients completed the study which was a double-blind , placebo-controlled , cross-over trial . The patients received either NAC or placebo for two periods of three months followed by a three month follow-up period . Active treatment consisted of NAC , either 200 mg x 3 daily ( patients weighing less than 30 kg ) or 400 mg x 2 daily ( greater than 30 kg ) . The effect was evaluated in terms of a subjective clinical score , weight , sputum bacteriology , blood leucocyte count , sedimentation rate , titres of specific antimicrobial antibodies , lung function parameters and measurement of the ciliary function . No effect was seen in PCD patients , but in CF patients an improved lung function was seen in the period when the patients suffer most from lower airway infections We report a double blind placebo-controlled phase II study of the efficacy and safety of nebulized recombinant human DNase ( rhDNase ) administered for 14 d to adults with bronchiectasis not caused by cystic fibrosis . All were in a stable clinical state at the commencement of the study , and they received ( 1 ) rhDNase 2.5 mg twice daily , ( 2 ) rhDNase once daily , or ( 3 ) placebo ( excipient only ) inhalation . The outcome measures were spirometry , subjective quality of life/dyspnea , and safety . We also measured the ciliary transportability of the sputum expectorated before and after the treatment period , using the mucus-depleted bovine trachea . The drug was well tolerated , but it produced no significant change in any of the outcome variables or in sputum transportability . When the drug was incubated with bronchiectatic sputum in vitro , a fall in transportability was observed . We discuss possible explanations for the lack of a measurable benefit from rhDNase in this study population , which appears to contrast with the improvements shown in cystic fibrosis using studies of similar design Bromhexeine has been widely used as an adjunct in the management of lower respiratory infections and is useful in altering the physical characteristics of sputum . Its effect on the sputum penetration of an antibiotic has been sparsely studied . The present study highlights the improvement in sputum amoxycillin ( amoxy ) levels when a combination tablet , amoxy 500 mg plus bromhexeine 8 mg , is administered as compared to plain amoxy 500 mg . Sputum amoxy levels were significantly higher in the combination group ( 0.674 + /- 0.588 micrograms ml-1 ) as compared to 0.272 + /- 0.19 micrograms ml-1 in the amoxy group ( P = 0.028 ) . The clinical responses assessed by the physician as well as the patient were significantly better in the amoxy plus bromhexeine group as compared to the amoxy group . The radiological and bacteriological responses were similar in both groups . There was no increase in the side-effects due to bromhexeine and , overall , its use can be recommended in the treatment of acute lower respiratory infections STUDY OBJECTIVE To study the safety and efficacy of aerosolized recombinant human DNase I in the treatment of idiopathic bronchiectasis . DESIGN Double-blind , r and omized , placebo-controlled , multicenter study . POPULATION S Three hundred forty-nine adult out patients in stable condition with idiopathic bronchiectasis from 23 centers in North America , Great Britain , and Irel and . INTERVENTIONS AND MEASUREMENTS Study patients received aerosolized rhDNase or placebo twice daily for 24 weeks . Primary end points were incidence of pulmonary exacerbations and mean percent change in FEV1 from baseline over the treatment period . RESULTS Pulmonary exacerbations were more frequent and FEV1 decline was greater in patients who received rhDNase compared with placebo during this 24-week trial . CONCLUSIONS rhDNase was ineffective and potentially harmful in this group of adult out patients in stable condition with idiopathic bronchiectasis . This contrasts with previously published results that demonstrated efficacy of rhDNase in patients with cystic fibrosis bronchiectasis Summary : A double-blind crossover clinical trial design ed to evaluate the mucolytic activity of bromhexine hydrochloride on sputum was completed by 15 patients with chronic lung disease . All the subjects chosen were troubled by production of tenacious mucoid or mucopurulent sputum at the beginning of the trial . Each subject received 16 mg of bromhexine by mouth , three times daily and identical appearance placebo tablets , for an equal number of weeks , in r and om sequence . Twenty-four-hour sputum production was collected for each subject throughout the trial . Viscosity of sputum was evaluated with a Wells-Brookfield Micro-Viscometer Model RVT , study ing the highest viscosity sample produced per 24-hour period . In eight patients some significant decrease in sputum viscosity was observed during bromhexine therapy . In one patient a significant decrease in sputum viscosity was observed while he was receiving the placebo . The mean sputum viscosity for all 15 patients considered as a group was significantly lower during bromhexine therapy than during the placebo therapy . It is concluded from the results obtained that bromhexine has a demonstrable mucolytic effect on tenacious sputum and consequently may play a useful role in the management of patients with chronic lung disease involving the production of high viscosity bronchial secretions BACKGROUND The synthetic mucolytic neltene-xine is an amide derivative of ambroxol and thiophencarboxylic acid . The aim of this open , r and omised , controlled study versus sobrerol was to evaluate the efficacy and tolerability of neltenexine ( oral granules in sachets ) as compared with sobrerol ( oral granules in sachets ) , administered to patients with obstructive airways disease . METHODS Thirty male and female patients were recruited . The exclusion criteria were allergy to neltenexine or sobrerol , an assessed diagnosis of severe bronchospasm requiring beta2-agonists , corticosteroids or aminophylline , pregnant or nursing women , cystic fibrosis , active tuberculosis or an assessed diagnosis of bronchiectasis . No infections of other organs ( such as urinary tract infections ) were present at baseline . Concomitant treatment with antitussives or other mucolytic agents was not allowed during the course of the study . Fifteen patients were r and omised to treatment with neltenexine , 1 sachet thrice daily for 20 days orally ( neltenexine group ) and 15 patients to treatment with sobrerol , 1 sachet thrice daily for 20 days orally ( sobrerol group ) . The efficacy parameters were : sputum characteristics and volume , difficulty in expectorating , cough , dyspnoea , pulmonary auscultation . Tolerability was monitored and adverse events were reported . RESULTS The study highlighted that neltenexine has a good efficacy in the treatment of patients with obstructive airways disease entailing significant impairment of clinical parameters . CONCLUSIONS Neltenexine can be an effective therapeutic alternative to sobrerol Bronchiectasis is a disease characterized by hypersecretion and retention of mucus requiring physical and ph \n Output:\n " }, { "from": "agent", "value": "There was no difference in forced expiratory volume .\nIn a second study , compared to placebo , recombinant human DNase showed no difference in forced expiratory volume or forced vital capacity .\nAdverse effects , including influenza-like symptoms , were more common in the group receiving recombinant human DNase .\nREVIEW ER 'S CONCLUSIONS There is not enough evidence to evaluate the routine use of mucolytics for bronchiectasis .\nHigh doses of bromhexine coupled with antibiotics may help with sputum production and clearance" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background and Purpose — Exposure to vascular risk factors has a gradual deleterious effect on brain MRI and cognitive measures . We explored whether a pattern of these measures exists that predicts stroke and Alzheimer disease ( AD ) risk . Methods — A cognitive battery was administered to 1679 dementia and stroke-free Framingham offspring ( age , > 55 years ; mean , 65.7±7.0 ) between 1999 and 2004 ; participants were also free of other neurological conditions that could affect cognition and > 90 % also had brain MRI examination . We related cognitive and MRI measures to risks of incident stroke and AD ⩽10 years of follow-up . As a secondary analysis , we explored these associations in The Framingham Heart Study original cohort ( mean age , 67.5±7.3 and 84.8±3.3 years at the cognitive assessment and MRI examination , respectively ) . Results — A total of 55 Offspring participants sustained strokes and 31 developed AD . Offspring who scored < 1.5 SD below predicted mean scores , for age and education , on an executive function test , had a higher risk of future stroke ( hazard ratio [ HR ] , 2.27 ; 95 % confidence interval [ CI ] , 1.06–4.85 ) and AD ( HR , 3.60 ; 95 % CI , 1.52–8.52 ) ; additional cognitive tests also predicted AD . Participants with low ( < 20 percentile ) total brain volume and high ( > 20 percentile ) white matter hyperintensity volume had a higher risk of stroke ( HR , 1.97 ; 95 % CI , 1.03–3.77 and HR , 2.74 ; 95 % CI , 1.51–5.00 , respectively ) but not AD . Hippocampal volume at the bottom quintile predicted AD in the offspring and original cohorts ( HR , 4.41 ; 95 % CI , 2.00–9.72 and HR , 2.37 ; 95 % CI , 1.12–5.00 , respectively ) . A stepwise increase in stroke risk was apparent with increasing numbers of these cognitive and imaging markers . Conclusions — Specific patterns of cognitive and brain structural measures observed even in early aging predict stroke risk and may serve as biomarkers for risk prediction BACKGROUND Analyses of some r and omised trials show that calcium-channel blockers reduce the risk of stroke more than expected on the basis of mean blood pressure alone and that beta blockers are less effective than expected . We aim ed to investigate whether the effects of these drugs on variability in blood pressure might explain these disparities in effect on stroke risk . METHODS The Anglo-Sc and inavian Cardiac Outcomes Trial Blood Pressure Lowering Arm ( ASCOT-BPLA ) compared amlodipine-based regimens with atenolol-based regimens in 19 257 patients with hypertension and other vascular risk factors and the Medical Research Council ( MRC ) trial compared atenolol-based and diuretic-based regimens versus placebo in 4396 hypertensive patients aged 65 - 74 years . We expressed visit-to-visit variability of blood pressure during follow-up in the two trials as st and ard deviation ( SD ) and as transformations uncorrelated with mean blood pressure . For ASCOT-BPLA , we also studied within-visit variability and variability on 24 h ambulatory blood-pressure monitoring ( ABPM ) . RESULTS In ASCOT-BPLA , group systolic blood pressure ( SBP ) SD was lower in the amlodipine group than in the atenolol group at all follow-up visits ( p<0.0001 ) , mainly because of lower within-individual visit-to-visit variability . Within-visit and ABPM variability in SBP were also lower in the amlodipine group than in the atenolol group ( all p<0.0001 ) . Analysis of changes from baseline showed that variability decreased over time in the amlodipine group and increased in the atenolol group . The lower risk of stroke in the amlodipine group ( hazard ratio 0.78 , 95 % CI 0.67 - 0.90 ) was partly attenuated by adjusting for mean SBP during follow-up ( 0.84 , 0.72 - 0.98 ) , but was abolished by also adjusting for within-individual SD of clinic SBP ( 0.99 , 0.85 - 1.16 ) . Findings were similar for coronary events . In the ABPM sub study , reduced variability in daytime SBP in the amlodipine group ( p<0.0001 ) partly accounted for the reduced risk of vascular events , but reduced visit-to-visit variability in clinic SBP had a greater effect . In the MRC trial , group SD SBP and all measures of within-individual visit-to-visit variability in SBP were increased in the atenolol group compared with both the placebo group and the diuretic group during initial follow-up ( all p<0.0001 ) . Subsequent temporal trends in variability in blood pressure during follow-up in the atenolol group correlated with trends in stroke risk . INTERPRETATION The opposite effects of calcium-channel blockers and beta blockers on variability of blood pressure account for the disparity in observed effects on risk of stroke and expected effects based on mean blood pressure . To prevent stroke most effectively , blood-pressure-lowering drugs should reduce mean blood pressure without increasing variability ; ideally they should reduce both Background and Purpose — The association between stroke and subsequent dementia or Alzheimer disease is well established . What is less understood is the extent to which this association is dependent on prestroke cognitive functioning . The study estimated the occurrence in poststroke dementia as a function of prestroke cognitive status and incident stroke . Methods — Study data were derived from the English Longitudinal Study of Ageing , a 10-year long prospect i ve cohort study of older adults living in Engl and . Baseline data ( 2002/2003 ) were used to group participants into tertiles of cognitive , memory , and executive functioning before an incident stroke . Data from 4 follow-up surveys were used to identify new stroke and poststroke dementia events . Results — The analyses were based on 10 809 participants aged ≥50 years at baseline . High prestroke executive functioning was associated with lower relative risk ( RR ) of dementia ( RR , 0.24 ; 95 % confidence interval , 0.13–0.45 ; P<0.001 ) . Stroke was associated with increased RR of poststroke dementia ( RR , 2.63 ; 95 % confidence interval , 1.80–3.84 ; P<0.001 ) . The association of stroke with poststroke dementia was greater for participants with higher prestroke executive functioning ( interaction term RR , 4.4 ; 95 % confidence interval , 1.35–14.63 ; P=0.014 ) . For participants with higher executive functioning , the probability of dementia was 0.3 % without stroke and 3.1 % after stroke , compared with 1.9 % and 5.2 % for lower executive functioning . Conclusions — Stroke and prestroke cognition were independently associated with increased probability of poststroke dementia . Stroke results in disproportionate increase in the risk of dementia when premorbid cognitive functioning is high BACKGROUND Silent brain infa rcts are frequently seen on magnetic resonance imaging ( MRI ) in healthy elderly people and may be associated with dementia and cognitive decline . METHODS We studied the association between silent brain infa rcts and the risk of dementia and cognitive decline in 1015 participants of the prospect i ve , population -based Rotterdam Scan Study , who were 60 to 90 years of age and free of dementia and stroke at base line . Participants underwent neuropsychological testing and cerebral MRI at base line in 1995 to 1996 and again in 1999 to 2000 and were monitored for dementia throughout the study period . We performed Cox proportional-hazards and multiple linear-regression analyses , adjusted for age , sex , and level of education and for the presence or absence of subcortical atrophy and white-matter lesions . RESULTS During 3697 person-years of follow-up ( mean per person , 3.6 years ) , dementia developed in 30 of the 1015 participants . The presence of silent brain infa rcts at base line more than doubled the risk of dementia ( hazard ratio , 2.26 ; 95 percent confidence interval , 1.09 to 4.70 ) . The presence of silent brain infa rcts on the base-line MRI was associated with worse performance on neuropsychological tests and a steeper decline in global cognitive function . Silent thalamic infa rcts were associated with a decline in memory performance , and nonthalamic infa rcts with a decline in psychomotor speed . When participants with silent brain infa rcts at base line were subdivided into those with and those without additional infa rcts at follow-up , the decline in cognitive function was restricted to those with additional silent infa rcts . CONCLUSIONS Elderly people with silent brain infa rcts have an increased risk of dementia and a steeper decline in cognitive function than those without such lesions OBJECTIVES To investigate the effect of cognitive impairment on fatal and nonfatal incident stroke in older adults . DESIGN A large , national , prospect i ve , population -based study of a representative cohort of older Canadians followed over a 10-year period . SETTING Secondary analyses were conducted using data from the Canadian Study of Health and Aging , a population -based study of older adults followed prospect ively from 1991 to 2001 . PARTICIPANTS Nine thous and four hundred fifty-one adults aged 65 and older who had not previously been diagnosed with stroke at baseline ( in 1991 ) . MEASUREMENTS In addition to known risk factors , the independent contribution of cognitive function ( diagnosed in a clinical examination ) was examined as a risk for stroke in older adults . RESULTS Multinomial logistic regression analyses showed that cognitive impairment was associated with twice the odds of fatal incident stroke , controlling for well-established risk factors . CONCLUSION This study provides further evidence for the need to consider cognitive function in relation to stroke risk in older population OBJECTIVE Recent studies have suggested that vascular dementia in older persons is more common than previously hypothesized . A substantial proportion of dementia in old age may be an early manifestation of cerebrovascular disease ( CVD ) , that eventually becomes clinical ly evident as an acute cerebrovascular accident . This study was aim ed at assessing whether cognitive impairment and cognitive decline in older persons free of stroke are associated with higher risk of future stroke , independently of other risk factors . DESIGN Population -based prospect i ve study . PARTICIPANTS A total of 5024 subjects from the Established Population s for Epidemiologic Studies of the Elderly , who were alive and had no history of previous stroke at the sixth follow-up visit . Subjects who had reported a stroke in a previous interview or with a diagnosis of cerebrovascular disease in a hospitalization record during the previous 3 years were excluded . MEASUREMENTS Cognitive function was assessed by the Short Portable Mental Status Question naire ( SPMSQ ) . Occurrence of a stroke was prospect ively assessed by examining hospital discharge diagnoses and death certificates . RESULTS During 19,533 person-years of follow-up , 259 strokes were recorded ( 13.3/1000 person-years ) . Stroke incidence was lowest in those with normal SPMSQ score ( 12.1/1000 person-years ) , intermediate in those with moderate impairment ( 16.3/1000 person-years ) , and highest in those with severe impairment ( 30.9/1000 person-years ) . Adjusting for age , education , smoking , history of hypertension , blood pressure , heart attack , diabetes , and disability , the relative risks of stroke for moderate and severe cognitive impairment were 1.2 ( 0.9 - 1.6 ) and 2.2 ( 1.2 - 3.8 ) , respectively . The association between cognitive impairment and incident stroke was not mediated by hypertension or diabetes . Compared with subjects with stable or improved SPMSQ score in the previous 3 years , those who declined had higher risk of stroke . CONCLUSIONS The elevated risk of subsequent strokes in older persons with cognitive impairment suggests that CVD may play larger role in causing cognitive impairment then previously suspected . It remains to be demonstrated whether reducing modifiable risk factors for CVD decreases the burden of cognitive impairment in older persons without stroke Background and Purpose — Several studies indicate that stroke increases the risk of dementia . Most of these studies lacked the ability to take accurately assessed prestroke cognitive function into account . Whether the effects of stroke merely unravel an ongoing underlying dementing process or in fact cause the dementia has implication s for the prevention of dementia in persons with cerebrovascular disease . We explored in a prospect i ve cohort study whether stroke occurrence was related to a higher risk of subsequent dementia and whether this association was dependent on prestroke slope of cognitive function . Methods — Cox proportional hazard models were used to relate incident stroke as a time-varying exposure with the risk of dementia in 6724 participants of the Rotterdam Study without dementia or stroke at baseline ( 49 361 person years of follow-up ) . Subsequently Cox proportional hazard models were performed to assess whether this association was dependent on slope of prestroke cognitive performance and other risk factors for cognitive decline . Results — Independent \n Output:\n " }, { "from": "agent", "value": "INTERPRETATION Baseline cognitive impairment was associated with a significantly higher risk of future stroke , especially ischemic and fatal stroke" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The efficacy and acceptability of two third generation oral contraceptives in Thai women were evaluated in a prospect i ve , open , group-comparative , r and omized , multicenter trial of women asking for contraception . In six Family Planning Centers and Outpatient Gynaecological Clinics in urban areas in Thail and , 783 healthy women who were at risk for pregnancy and did not have contraindications to oral contraceptive use were r and omly allocated to one of the two study groups . An oral contraceptive containing 30 mcg ethinylestradiol and 150 mcg desogestrel was given to 394 women and an oral contraceptive with the same amount of ethinylestradiol and 75 mcg gestodene to 389 women during 6 cycles . Criteria of cycle control , side effects and the presence and severity of acne vulgaris were assessed and blood pressure and body weight measured at pretreatment and after cycles 1 , 3 and 6 . Furthermore , the efficacy was evaluated after the last cycle . No pregnancies occurred with either of the contraceptives . The incidences of irregular bleeding and minor side effects in both groups were very low and decreased after an initial increase in the first cycle . Acne improved in both groups . Blood pressure and body weight remained unchanged . The two oral contraceptives were found to be effective and acceptable in Thai women . Compared to Caucasian women , the incidences of irregular bleeding and side effects were apparently lower in these Asian women . Furthermore , the effects of both oral contraceptives were comparable Two monophasic oral contraceptives containing gestodene ( GTD , 75 micrograms ) and ethinylestradiol ( EE , 30 micrograms ) or norgestimate ( NGS , 250 micrograms ) and EE ( 35 micrograms ) were compared during the first six cycles of use . The subjects were r and omly assigned to receive either type : 97 received GTD/EE and 92 NGS/EE . Six women in the GTD/EE group and nine in the NGS/EE group withdrew from the study ; three ( 3 % ) and two ( 2 % ) , respectively , withdrew because of adverse reactions . A total of 562 cycles for GTD/EE and 523 for NGS/EE were available . No woman became pregnant during the study . Overall , 94.4 % of cycles in the GTD/EE group and 92.8 % in the NGS/EE group were normal . A similar incidence of breakthrough bleeding ( 0.2 % of cycles for GTD and 1.6 % for NGS ) and spotting ( 5.4 % vs. 5.6 % ) was observed . Amenorrhea was never reported . Duration of withdrawal bleeding tended to be slightly longer in the NGS/EE group , significantly so for cycles 2 ( 0.5 days , p = 0.016 ) , 4 ( 0.5 days , p = 0.031 ) and 5 ( 0.4 days , p = 0.045 ) . Cycle 2 was significantly longer in the GTD/EE group ( 0.3 days , p = 0.027 ) . Side-effects were reported by 12 ( 12 % ) women in the GTD/EE group and 13 ( 14 % ) in the NGS/EE group . The most common side-effects were headache ( five cases ( 5 % ) in the GTD/EE group and two ( 2 % ) in the NGS/EE group ) and breast pain ( three ( 3 % ) and eight ( 9 % ) cases respectively ) . There were no statistically significant differences between the two groups with respect to change in body weight or changes in blood pressure and in laboratory data . ( ABSTRACT TRUNCATED AT 250 WORDS The efficacy , cycle control , subjective complaints , and safety of monophasic preparations of the oral contraceptives containing gestodene 75 mcg plus ethinyl estradiol 30 mcg versus desogestrel 150 mcg plus ethinyl estradiol 30 mcg were compared in a 6-cycle , open-label , parallel , r and omized , multicenter phase IV clinical study in Latin America . Of a total of 176 women in each group , 163 in the gestodene group and 160 in the desogestrel group completed 6 cycles , providing data for 1,015 and 1,006 cycles , respectively . Subject compliance was excellent ; pills were missed during only 6.9 % of the cycles in each group . No woman became pregnant during the study . Gestodene group exhibited significantly better cycle control as evidence d by the lower incidence of breakthrough bleeding and spotting . Spotting in some cycles was reported by 11.9 % of women taking the gestodene-combination compared with 21 % of women taking the desogestrel-combination . Based on number of women , 86.4 % of the gestodene group reported all cycles were normal ( no BTB ) compared with 76.7 % of the desogestrel group . Also , the women in the gestodene group reported a significantly lower incidence of nuisance side effects during treatment cycles . No amenorrhea was observed for either group . There were no clinical ly significant differences between groups with respect to body weight , blood pressure , or laboratory evaluations . Seven women withdrew from the gestodene group and 8 women withdrew from the desogestrel group because of adverse reactions . The results of this study indicate that , although both OCs provided effective contraception , in comparison to the desogestrel-combination , the gestodene-containing OC is associated with better cycle control , less bleeding , and fewer subjective complaints OBJECTIVES Our purpose was to define the frequency and reasons for oral contraceptive discontinuation and subsequent contraceptive behavior . STUDY DESIGN A nationwide prospect i ve study of 1657 women initiating or switching to the use of a new contraceptive from private practice s , clinics , and a health maintenance organization was performed . RESULTS Six months after a new oral contraceptive prescription , 68 % of new starts and 84 % of switchers still used oral contraceptives . Of women who discontinued , 46 % did so because of side effects , whereas 23 % had no continuing need . More than four fifths of women who discontinued oral contraceptives but remained at risk of unintended pregnancy either failed to adopt another method or adopted a less effective method . Fifteen percent of women who discontinued oral contraceptives resumed their use within the 7-month follow-up period . CONCLUSIONS Counseling should emphasize the possibility of side effects , stressing the fact that most will be transient , and the need to identify a backup method . Follow-up visits should be scheduled for 1 to 2 months after a prescription is written The efficacy , cycle-control and tolerance of Microgynon-30 , a widely prescribed levonorgestrel containing oral contraceptive , and Femodene , a new oral-contraceptive containing gestodene , were compared in a r and omised , double-blind study involving 456 healthy women over a 6 month period . 229 women were allocated to receive Femodene and 227 received Microgynon-30 . No differences between the groups in terms of obstetric and gynaecological history , previous contraceptive history , smoking habits , blood-pressure or body weight at admission were observed . No pregnancies were reported in either group , despite tablet-taking errors recorded in 6.3 % of the Femodene group and 7.6 % of the Microgynon-30 group . Both oral contraceptives were compared in terms of cycle length , intensity of the withdrawal bleed and side effects . Cycle-control was similar in the two groups . However , significantly fewer subjects reported breakthrough bleeding ( with or without spotting ) in the Femodene group ( 18 % of patients ) compared with the Microgynon-30 group ( 26 % of patients ) . The incidence of absent withdrawal bleeds was 1 % or less in both groups and no significant effects on body weight or blood pressure were observed OBJECTIVE The primary objective of this study was to compare the safety , contraceptive efficacy , and menstrual cycle patterns in women using triphasic oral contraceptive pills , namely CTR-05 , containing 50/100/150 micrograms desogestrel and 35/30/30 micrograms ethinylestradiol , and Orthonovum777 containing 500/750/1000 micrograms norethindrone and 35/35/35 micrograms ethinylestradiol . METHOD Forty-six female volunteers , satisfying the selection criteria , were evaluated for six cycles , in an open-label , r and omized study . Volunteers using CTR-05 were studied for 13 additional cycles for efficacy and safety . RESULTS No serious adverse effects were observed in either group . The incidences of other drug-related adverse effects , such as headache and nausea , were transient in both groups . CTR-05 did not lower levels of high density lipoprotein ( HDL ) cholesterol . This may be attributed to the lower and rogenicity of its progestin component , desogestrel . No pregnancies were reported in either group . Clinical and laboratory parameters remained within normal limits in both groups . In the CTR-05 group , the lower dose of ethinylestradiol did not affect the safety , efficacy and acceptability of the product . CONCLUSION Desogestrel , with little estrogenic activity and only minimal and rogenic activity , leads to lipoprotein changes , result ing in a favorable cardiovascular profile , as well as minimal and rogen-related effects , such as hirsutism and acne Oral contraceptives have the highest theoretic efficacy of all reversible forms of contraception , yet in practice they have an actual failure rate equivalent to that of some barrier methods . The efficacy of oral contraceptives depends primarily on patient compliance . So-called \" nuisance \" side effects , such as intermenstrual bleeding ( breakthrough bleeding or spotting ) , play a major role in their discontinuation . The Triphasic R and omized Clinical Trial compared the incidence of these side effects in three groups of subjects taking NET ( A ) ( Ortho-Novum 7/7/7 ) , LNG ( Tri-Levlen ) , or NET ( B ) ( Tri-Norinyl ) . Subjects taking NET ( A ) had the highest incidence of intermenstrual bleeding ( 63 % ) followed by NET ( B ) ( 44 % ) and LNG ( 33 % ) . Only the difference between NET ( A ) and LNG attained statistical significance ( p less than 0.030 ) . Control subjects had no breakthrough bleeding and a 4 % incidence of spotting . Further research is warranted to establish the cause of the disparity in the incidence of intermenstrual bleeding among patient groups assigned to the three oral triphasic contraceptives OBJECTIVE To assess the contraceptive efficacy , cycle control and acceptability of two monophasic oral contraceptives containing either 30 micrograms ethinylestradiol plus 150 micrograms desogestrel or 30 micrograms ethinylestradiol plus 75 micrograms gestodene . METHODS In a r and omized , open-label , six-cycle , group-comparative , multicenter study performed in Brazil , pregnancies , cycle-control parameters , incidence of side-effects and the presence and severity of acne vulgaris were assessed , and blood pressure and body weight were measured at pretreatment and after one , three and six cycles of oral contraceptive use . RESULTS Of the 595 women enrolled , 274 ( 86.7 % ) in the desogestrel/ethinylestradiol group and 227 ( 81.4 % ) in the gestodene/ethinylestradiol group completed the six cycles , providing data for 1753 and 1487 treatment cycles , respectively . Two pregnancies occurred , one of which ( in the desogestrel/ethinylestradiol group ) was attributed to user failure , whilst the other ( in the gestodene/ethinylestradiol group ) was thought to result from method failure . Cycle control was observed to be excellent ; the incidences of irregular bleeding and minor side-effects were low in both groups and decreased after an initial increase in the first cycle . Pre-existing acne improved in both groups , whereas blood pressure and body weight remained essentially unchanged . CONCLUSIONS Both desogestrel/ethinylestradiol and gestodene/ethinylestradiol provide effective oral contraception with comparable cycle control and acceptability OBJECTIVE To assess the contraceptive reliability , cycle control and tolerance of a new monophasic oral contraceptive ( Yasmin ) containing 30 microg ethinylestradiol and 3 mg drospirenone and compare it with a preparation containing an equal dose of ethinylestradiol combined with 150 microg desogestrel ( Marvelon ) . METHODS A multicenter , open-label , r and omized study was carried out in 26 European centers . Contraceptive efficacy , cycle control and tolerance ( including body weight , blood pressure and heart rate ) were assessed over 26 cycles , plus a 3-month follow-up period . RESULTS Of 900 women who were r and omized , 887 started treatment and 627 completed the 26 cycles plus follow-up ( 310 in the ethinylestradiol/drospirenone group and 317 in the ethinylestradiol/desogestrel group ) . Both study preparations were found to be effective with regard to contraceptive reliability and cycle control was good . There were six pregnancies ( three in each group ) , but none were considered to have been the result of method failures . The subjective and objective tolerances were good in both groups . A statistically significant difference was found in body weight changes between the two groups . While there \n Output:\n " }, { "from": "agent", "value": "Intermenstrual bleeding was less with third- compared to second-generation pills ( RR 0.71 ; 95 % CI 0.55–0.91).Contraceptive effectiveness of gestodene ( GSD ) was comparable to that of levonorgestrel ( LNG ) , and had similar pattern of spotting , breakthrough bleeding and absence of withdrawal bleeding ) .\nDrospirenone ( DRSP ) was similar compared to desogestrel ( DSG ) regarding contraceptive effectiveness , cycle control and side effects .\nConclusion The third- and second-generation progestogens are preferred over first generation in all indices of acceptability .\nCurrent evidence suggests that GSD is comparable to LNG in terms of contraceptive effectiveness and for most cycle control indices .\nGSD is also comparable to DSG .\nDRSP is comparable to DSG ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Abdominal aortic aneurysm is a multifactorial disorder in which inflammation is an important pathophysiological feature . In explant culture , aneurysm biopsies secrete large amounts of interleukin-6 ( IL-6 ) , and among aneurysm patients , the circulating concentration of IL-6 appears to be increased . Methods and Results We investigated , in 19 patients , whether aneurysm wall was an important source of circulating IL-6 . We also tested the hypotheses , in 466 patients with a small aneurysm , that ( 1 ) high concentrations of circulating IL-6 signaled rapid aneurysm growth and ( 2 ) the −174 G→C polymorphism in the IL-6 promoter predicted survival . For 19 patients with large or inflammatory aneurysms , the concentration of IL-6 was higher in the iliac arteries than the brachial arteries ( median difference 26.5 pg/mL , this difference increasing with aneurysm diameter , P = 0.01 ) . In 466 patients with small aneurysms , the frequency of the −174 C allele ( 0.40 ) was similar to that in a normal healthy population . Patients of GG genotype had lower plasma concentrations of IL-6 than patients of GC and CC genotypes ( medians 1.9 , 4.8 , and 15.6 pg/mL , respectively , Kruskal-Wallis P = 0.047 ) . Cardiovascular and all-cause mortalities were lower for patients of GG genotype than for patients of GC and CC genotype : hazard ratios 0.32 ( 95 % CI 0.12 to 0.93 ) , P = 0.036 , and 0.51 ( 95 % CI 0.25 to 1.00 ) , P = 0.05 , respectively . There was no association between plasma IL-6 or IL-6 genotype and aneurysm growth . Conclusions Aortic aneurysms appear to be an important source of circulating IL-6 , the concentration being influenced by genotype . For patients with small aneurysms , the −174 G→C IL-6 genotype predicts future cardiovascular mortality CONTEXT Among patients with abdominal aortic aneurysm ( AAA ) who have high operative risk , repair is usually deferred until the AAA reaches a diameter at which rupture risk is thought to outweigh operative risk , but few data exist on rupture risk of large AAA . OBJECTIVE To determine the incidence of rupture in patients with large AAA . DESIGN AND SETTING Prospect i ve cohort study in 47 Veterans Affairs medical centers . PATIENTS Veterans ( n = 198 ) with AAA of at least 5.5 cm for whom elective AAA repair was not planned because of medical contraindication or patient refusal . Patients were enrolled between April 1995 and April 2000 and followed up through July 2000 ( mean , 1.52 years ) . MAIN OUTCOME MEASURE Incidence of AAA rupture by strata of initial and attained diameter . RESULTS Outcome ascertainment was complete for all patients . There were 112 deaths ( 57 % ) and the autopsy rate was 46 % . Forty-five patients had probable AAA rupture . The 1-year incidence of probable rupture by initial AAA diameter was 9.4 % for AAA of 5.5 to 5.9 cm , 10.2 % for AAA of 6.0 to 6.9 cm ( 19.1 % for the subgroup of 6.5 - 6.9 cm ) , and 32.5 % for AAA of 7.0 cm or more . Much of the increased risk of rupture associated with initial AAA diameters of 6.5 - 7.9 cm was related to the likelihood that the AAA diameter would reach 8.0 cm during follow-up , after which 25.7 % ruptured within 6 months . CONCLUSION The rupture rate is substantial in high-operative-risk patients with AAA of at least 5.5 cm in diameter and increases with larger diameter PURPOSE Chlamydia Pneumoniae has been shown to be associated with atherosclerosis , myocardial infa rct ion , and abdominal aortic aneurysms ( AAAs ) . The possible association between AAA expansion and C pneumoniae infection was therefore assessed . METHODS Blood sample s were taken from patients with an AAA that was considered for surgical repair after having been diagnosed by means of the Chichester aneurysm screening program ( UK ) as having an initially infrarenal aortic diameter of 3.0 to 5.9 cm . The patients were examined prospect ively for as long as 11.5 years ( mean , 4.1 years ) with ultrasound scanning . Of 110 patients considered for surgery , 90 men and 10 women had blood sample s taken . Their IgG and IgA antibodies against C pneumoniae were measured by means of a microimmunofluorescence test . Unpaired t tests , multiple linear regression analyses , and logistic regression analyses were used for statistical analysis . RESULTS A total of 44 % ( 95 % CI , 31%-55 % ) of the men with an AAA had an IgA titer of 64 or more , an IgG titer of 128 or more , or both , compared with 10 % of the women with an AAA ( OR = 7.2 ; 95 % CI , 1.05 - 160.8 ) . A titer of IgG of 128 or more was significantly associated with higher expansion ( 5.3 vs 2.6 mm per year ) , even after adjustment for initial AAA size and age . A significant positive correlation between both IgA and IgG titers and mean annual expansion was observed ( r = 0.28 ; 95 % CI , 0.05 - 0.49 ; and r = 0.45 ; 95 % CI , 0.24 - 0.62 , respectively ) , persisting after adjusting for initial AAA size and age . An IgG titer of 128 or more was present significantly more often in cases with an expansion greater than 1 cm annually ( adjusted OR = 12.6 ; 95 % CI , 1.37 - 293 ) . CONCLUSION A high proportion of men with an AAA has signs of infection with C pneumoniae . The progression of their AAAs was positively correlated with the presence of indicators of C pneumoniae infection OBJECTIVES endothelin 1,2 plays a significant role in the process of atherogenesis and vascular wall injury . The aim of this study was to assess whether plasma endothelin 1,2 levels were elevated in patients with large or symptomatic abdominal aortic aneurysms ( AAAs ) . DESIGN a prospect i ve open study . MATERIAL S AND METHODS plasma endothelin 1,2 levels were measured in 65 consecutive patients with infrarenal aortic aneurysms and compared with the levels in 44 healthy volunteer controls . The data for abdominal aneurysm patients was analysed in four subgroups : ( i ) small aneurysms ( < 5 cm ) , ( ii ) large aneurysms ( > /=5 cm ) , ( iii ) asymptomatic aneurysms and ( iv ) symptomatic aneurysms . Comparisons were made between endothelin 1,2 levels in aneurysm patients and controls and between the different aneurysm subgroups . RESULTS a highly significant difference ( p<0.0001 ) was found between aneurysm patients and controls . Patients with large aneurysms had significantly higher levels than patients with small aneurysms ( p<0.01 ) . There was no statistical difference in endothelin 1,2 levels between symptomatic and asymptomatic patients ; however , the highest levels were found in large , symptomatic aneurysms and the lowest in small , asymptomatic aneurysms . CONCLUSIONS plasma endothelin 1,2 is an endogenous marker of aneurysm diameter . Further studies are required to determine whether it relates to the rate of growth of aneurysms Abstract The pathogenesis of abdominal aortic aneurysms ( AAA ) is a complex process in which atherosclerosis and inflammation play a leading role . Cytokines are important mediators of both processes . The aim of our study was to determine whether plasma levels of cytokines which are most involved in AAA pathogenesis can be used as endogenous markers of AAA development , and thus to facilitate the decision on surgical intervention in cases when this is clinical ly unclear ( e.g. small AAA ) . In the prospect i ve study a total of 90 patients with AAA were examined . These patients were divided into the following groups according to symptoms and AAA diameter : symptomatic AAAs , including ruptures ( n=16 ) ; asymptomatic AAAs ( n=74 ) ; AAAs with a diameter of up to 5 cm ( n=30 ) , AAAs of 5–8 cm ( n=38 ) , and AAAs with a diameter over 8 cm ( n=22 ) . The average age of the patients was 70.7 ( 56–82 ) years . The male to female ratio was 4:1 ( 71:19 ) . A control group consisted of 30 healthy individuals of similar age and sex presentation with no manifestation of atherosclerosis . Plasma levels of cytokines were assessed in venous blood by means of radio- or enzymo-immunoassay . Statistical processing of the results was conducted with ANOVA and Wilcoxon tests with Spearman correlation , where p<0.05 was considered to be statistically significant . Plasma concentrations of cytokines were significantly higher in AAA patients than in healthy individuals . In AAA patients the tumour necrosis factor-α ( TNF-α ) and interleukin ( IL-8 ) levels were low in large and in symptomatic AAAs . IL-6 levels were increased with increasing AAA diameter and symptoms . IL-8 levels ( p<0.05 ) showed a statistically significant correlation with the diameter , and TNF-α ( p<0.05 ) with the symptoms of AAA . IL-1β , IL-2 and IL-6 did not show any significant changes with different AAA diameter or symptomatology . In Conclusion : IL-8 and TNF-α can be used as endogenous markers of the process of AAA development , in deciding for either surgical or endovascular treatment of patients when the clinical indication is not entirely clear BACKGROUND Serum C-reactive protein ( CRP ) has proven to be an independent marker of the extent of atherosclerosis in patients with coronary , cerebrovascular , and peripheral arterial disease . In this prospect i ve observational study , we wanted to assess the relationship between serum CRP and extent of disease transversely and longitudinally in time , as well as future cardiovascular complications in patients with peripheral arterial disease ( PAD ) . Hypothesizing that CRP not only is a marker of but also actively participates in atherogenesis , we explored the possibility of CRP production by femoral atherosclerotic plaques . METHODS Serum CRP was measured as highly sensitive ( hsCRP ) in 387 patients with PAD attending the vascular clinic of a university and 2 affiliated teaching hospitals . Serum hsCRP was related to the ankle-brachial pressure index ( ABPI ) as an indication of severity of disease at inclusion and at 12 months ' follow-up and to future events ( death and coronary , cerebral , and peripheral arterial events ) . In femoral plaques , the production of CRP was analyzed with reverse transcription-polymerase chain reaction , and CRP plaque localization was assessed with immunostaining on serial tissue sections with antibodies toward CRP , smooth muscle cells , T cells , and macrophages . RESULTS The hsCRP ( average + /- SD ) was 3.26 + /- 2.41 mg/L. Serum hsCRP showed a correlation with baseline and 12-month follow-up ABPI ( Spearman rank correlation ; P < .05 for both correlations ) . When the patients were divided into three equally sized groups according to baseline serum hsCRP , the ABPI at baseline and at 12 months decreased significantly from the low- to the high-hsCRP group ( baseline ABPI : 0.70 , 0.65 , and 0.57 , P < .01 ; 12-month follow-up ABPI : 0.78 , 0.70 , and 0.65 , P < .01 ) . These associations persisted after correction for conventional risk factors . Furthermore , serum hsCRP was related to the combined end point \" death and /or any cardiovascular event \" ( log-rank test ; P = .04 ) during a median 24-month follow-up period . Reverse transcription-polymerase chain reaction analysis showed CRP production in 4 of 14 femoral plaques . CRP was detected in all femoral plaques , but not in healthy brachial arteries . Immunoreactivity for CRP was observed in smooth muscle cells , macrophages , and T cells . CONCLUSIONS Serum hsCRP was related to the severity of PAD , showing a relation to future hemodynamic function and cardiovascular events in PAD patients . In addition to coronary plaques , aneurysmal aortas , and failed venous coronary bypasses , femoral plaques also produce CRP , thus illustrating that the production of CRP may represent a universal response to vascular injury and suggesting that vascular CRP may contribute to plaque development OBJECTIVE plasmin is a common activator of the known proteolytic systems involved in the aneurysmal degradation , and is reported to be associated with the expansion of abdominal aortic aneurysms ( AAA ) . The aim of this study was to \n Output:\n " }, { "from": "agent", "value": "Several potential biomarkers were identified .\nThe strongest association with AAA was obtained with serum elastin peptides ( SEP ) and plasmin-antiplasmin ( PAP ) complexes .\nMatrix-degrading metalloproteinase 9 ( MMP9 ) and interferon-gamma ( IFN-gamma ) could have clinical potential while many putative biomarkers showed poor association .\nSeveral circulating agents in peripheral blood may predict AAA size , expansion rate or rupture ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE To compare the therapeutic effectiveness of daily exposure to narrowb and ( NB ) UV-B vs broadb and ( BB ) UV-B with and without tar . DESIGN Half-body exposures to NB UV-B or BB UV-B were given daily for 4 weeks in this comparative treatment study . Narrowb and UV-B was delivered from TL-01 fluorescent bulbs and BB UV-B from conventional bulbs in the same phototherapy cabinet . Narrowb and UV-B was compared using a paired treatment approach to BB UV-B above the waist and to BB UV-B with tar ( Goeckerman treatment ) below the waist . SETTING General clinical research center of a university hospital inpatient unit . PATIENTS Twenty-two patients with moderate-to-severe plaque-type psoriasis completed the study . MAIN OUTCOME MEASURES Clinical efficacy was measured weekly using psoriasis severity scoring . Therapeutic outcomes after 4 weeks were compared in paired biopsy sample s from treated lesions using objective histopathological measures ( quantitative reduction in epidermal acanthosis and keratin 16 expression ) . RESULTS Clinical resolution of psoriasis was achieved on 86 % of paired sites treated with NB UV-B vs 73 % treated with BB UV-B. Histopathological resolution of epidermal hyperplasia ( marked by keratin 16 expression ) was achieved in 88 % of lesions treated with NB UV-B vs 59 % treated with BB UV-B. Epidermal acanthosis was reduced more completely by NB UV-B treatment . Clinical resolution of psoriatic lesions occurred more rapidly following NB UV-B treatment , with some patients achieving complete resolution after 2 to 3 weeks of treatment . CONCLUSIONS Narrowb and UV-B offers a significant therapeutic advantage over BB UV-B in the treatment of psoriasis , with faster clearing and more complete disease resolution . The erythema response to NB UV-B treatment was significantly more intense and persistent compared with BB UV-B. Considerably more necrotic keratinocytes were observed in histopathological sections of skin treated with NB UV-B after a single 2.0-minimum erythema dose exposure . Treatment should be coupled with obligate minimum erythema dose testing to NB UV-B and close clinical observation during dose increases BACKGROUND A narrow-b and UVB lamp ( Philips TL 01 ) emitting a peak of approximately 311 nm was developed to improve the phototherapy for psoriasis . Only a few studies have been performed with promising results . OBJECTIVE The therapeutic efficacy of the Philips TL 01 lamp in a new 100 W version was compared with conventional broad-b and lamps ( Sylvania UV 6 ) in a controlled trial . METHODS Twenty-three patients with psoriasis were treated with half-body exposures from the different UVB sources . The rate of clearing was monitored by estimation of the Psoriasis Area and Severity Index . All patients used emollients ; excessive scaling was removed with salicylic acid in yellow petrolatum . In 13 patients dithranol in a modified Ingram regimen was added . In most cases the study was discontinued once a difference between the two sides was evident . RESULTS In 20 of 23 cases the TL 01 lamp proved to be significantly more effective than the conventional source . Application of dithranol provided a substantial additional therapeutic effect . With the high-intensity TL 01/100W bulbs , exposure times were comparable to broad-b and UVB phototherapy . CONCLUSION The therapeutic efficacy of Philips TL 01/100W and its practicability for psoriasis phototherapy have been demonstrated The efficacy of trimethylpsoralen bath PUVA and UVB TL01 were compared in chronic plaque psoriasis . Patients were r and omly assigned to receive UVB TL01 on one side and bath PUVA on the contra-lateral side . Altogether 17 patients received treatments and 15 completed the trial . The decrease in the PASI score was greater with UVB TL01 than PUVA . At the end of the treatment period , the difference was highly significant ( p < 0.001 ) . The difference was already significant at week 3 ( p = 0.014 ) . The relative median decrease in the PASI score was 77 % ( 24 - 100 % ) with UVB and 45 % ( 8 - 100 % ) with PUVA . The median cumulative UVB dose was 39.92 ( range 13.95 - 81.56 ) J/cm2 and the corresponding UVA dose was 8.06 ( range 3.31 - 12.51 ) J/cm2 . All patients relapsed within 4 months . Narrowb and UVB improved psoriasis clinical ly and statistically more efficiently than trimethylpsoralen bath PUVA , and UVB was better tolerated Forty patients with pustulosis palmaris et plantaris were treated with tetracycline 250 mg twice daily or with placebo , in a double‐blind trial . In twenty‐eight patients the lesions were confined to the palms and soles , whereas twelve had psoriatic lesions affecting other parts of the skin and /or nails . Radiological signs of focal infection were found in eighteen patients . In thirty‐five patients positive bacteriological culture from pustules was obtained , the most common strain being Staphylococcus albus Twenty-nine patients with psoriasis took part in a study which compared the therapeutic effect of Philips TL12 with a new narrow-b and UVB lamp ( Philips TL01 ) . The patients were treated on an out-patient basis and treatment were given 3 - 5 times weekly for a maximum of 8 weeks . The study was conducted in a r and omized left-right double-blind fashion . The total score on the TL01-side decreased rather more than on the TL12-side . Eleven patients preferred the TL01 lamp and one the TL12-side , whereas 17 patients had no preference . One of the drawbacks with the new lamp is that radiation times are almost doubled INTRODUCTION Studies carried out to date comparing treatment with PUVA baths and narrow-b and UVB ( NBUVB ) in psoriasis show that better results are obtained with NBUVB . Certain features of the protocol s may interfere with the results . MATERIAL AND METHODS Prospect i ve study in a psoriasis unit , with treatment assigned according to availability . Of 167 patients with psoriasis plaques , 32 received PUVA baths ( photosensitizer 8-methoxypsoralen at a concentration of 2.6 mg/l ) and 135 received NBUVB radiation . A clearing rate of over 70 % was considered a good response . The data were described and compared between the two groups , including multivariate analysis techniques , in order to statistically control the effects of gender , number of sessions necessary for success , minimum phototoxic dose and minimum erythema dose . RESULTS A good response was obtained in 87.5 % of the cases with PUVA baths ( 95 % CI : 71.0 - 96.5 ) and in 87.4 % of the cases with NBUVB ( 95 % CI : 80.6 - 92.5 ) . No significant differences were found in the success and ab and onment percentages . Among the patients who responded to the treatment , no differences were found in the number of sessions or in the cumulative dose . Gender , cumulative dose or minimum phototoxic dose and minimum erythema dose values were not associated with the response to the treatments either . CONCLUSIONS With psoriasis plaques , similar response percentages can be expected with both treatments , using the proposed protocol s. The response is regardless of gender , cumulative dose and minimum phototoxic dose and minimum erythema dose values OBJECTIVE This was a double-blind , r and omized multicentre trial comparing efficacy and safety of brivudin ( 125 mg , once a day ) and famciclovir ( 250 mg , three times a day ) , both given orally for 7 days , in the treatment of herpes zoster . METHODS A total of 2027 immunocompetent zoster patients > or=50 years with zoster-related pain at presentation were included . Outcome measures embraced prevalence of postherpetic neuralgia ( PHN ) , defined as at least moderate pain 3 months after treatment initiation , duration of PHN , prevalence and duration of zoster-associated pain ( ZAP ) , duration of vesicle formation and rash healing . RESULTS The prevalence of PHN at month 3 was 11.3 % with brivudin and 9.6 % with famciclovir [ per- protocol ( PP ) population ] . Equivalence of the two drugs could be demonstrated ( P=0.01 , PP and intention-to-treat analysis ) . The median duration of PHN was 46.5 days with brivudin and 58 days with famciclovir ( P=0.54 , PP analysis ) . Prevalence and duration of ZAP did not differ significantly between treatment groups . The prevalence of PHN was higher in patients > or=65 years ( brivudin : 16.4 % , famciclovir : 16.4 % ) , and in patients with severe rash ( brivudin : 13.4 % , famciclovir : 15.7 % ) , without significant differences between treatment groups . In patients > or=65 years , median duration of PHN was shorter with brivudin than with famciclovir ( 39.5 vs. 57.5 days ) , although the difference was not statistically significant . The two drugs had equivalent efficacy in being able to accelerate the stop of vesicle formation , and lesion healing . Adverse events were similar in nature and prevalence among groups . CONCLUSIONS The study demonstrated equivalent efficacy of brivudin and famciclovir in the treatment of herpes zoster regarding the prevention of chronic pain and the resolution of signs and symptoms of acute herpes zoster . Compared with famciclovir , brivudin provides equivalent efficacy and safety at a more convenient once-daily dose schedule BACKGROUND Although PUVA treatment of psoriasis is more effective than conventional or broad-b and UVB phototherapy , two small studies have suggested that narrow-b and or TL-01 phototherapy may have a therapeutic effect equal to PUVA . If confirmed , this would be of considerable importance as TL-01 therapy is likely to be considerably safer in the long term than PUVA . OBJECTIVE The purpose of this study was to compare PUVA with narrow-b and ( TL-01 ) phototherapy in psoriasis . METHODS We studied 100 patients with plaque-type psoriasis who were r and omly allocated to twice-weekly treatment with PUVA or narrow-b and UVB . RESULTS Clearance of psoriasis was achieved in a significantly greater proportion of patients treated with PUVA ( 84 % ) than with TL-01 ( 63 % ) ( P = .018 ) , and with significantly fewer treatments ( median number of treatments for clearance with PUVA , 16.7 ; with TL-01 , 25.3 ; P = .001 ) . Only 12 % of those treated with TL-01 were clear of psoriasis 6 months after finishing treatment compared with 35 % for PUVA ( P = .002 ) . CONCLUSION When given twice weekly , PUVA is more effective for psoriasis than narrow-b and UVB phototherapy Continued prospect i ve study of the 1,380 patients enrolled in the PUVA study for 10 years after first exposure to PUVA demonstrates a strong association between cumulative exposure to PUVA and an increased risk of squamous cell carcinoma of the skin . For tumors occurring at least 58 months after first treatment , after adjustment for age , sex , and area of residence , we observed that patients with more than 260 treatments had an 11-fold increase in risk compared to patients who had received 160 or fewer treatments during the same interval ( P less than 0.01 ) . Comparable increases in relative risk were noted in patients of all skin types , irrespective of prior ionizing radiation exposure . We also noted a modest dose-dependent increase in the risk for the development of basal cell carcinoma for patients who received an excess of 200 treatments compared to those who had received fewer than 160 treatments within the same time period ( P less than 0.05 ) . Tumors detected in our cohort exhibit biologic behavior similar to non-melanoma skin cancers associated with sun exposure . Careful monitoring and early detection should limit the morbidity associated with these tumors A bilateral comparison study of the therapeutic effects of broad-b and ultraviolet ( UBV ) ( FS-40 Sunlamp bulbs ) radiation versus UVB radiation plus methoxsalen was conducted in patients with psoriasis . Ten patients were given up to 30 exposures to the two treatments on paired , similarly affected limbs . There was no detectable difference in the response of limbs treated with UVB plus methoxsalen versus UVB phototherapy alone although all patients did show a therapeutic response . Other areas of the body treated with methoxsalen and broad-b and UVA radiation ( PUVA bulbs ) responded more rapidly and to a greater extent than areas exposed to UVB radiation OBJECTIVE To compare the efficacy of oral psoralen-UV-A ( PUVA ) therapy with that of narrowb and UV-B ( NB-UVB ) therapy in patients with chronic plaque psoriasis . DESIGN Double-blind r and omized study . SET \n Output:\n " }, { "from": "agent", "value": "Evidence regarding NB-UVB versus bath PUVA is also inconsistent .\nRe-NB-UVB and re-PUVA are similarly effective for treating people with CPP or GP .\nIn practice , NB-UVB may be more convenient to use since exogenous photosensitiser is not required before phototherapy .\nNB-UVB is considered ineffective for PPP in clinical practice , and a small RCT did not detect a statistically significant difference between NB-UVB and topical PUVA for clearing PPP ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Benzydamine hydrochloride rinse was shown to prevent oral mucositis in radiation therapy . Prevention of mucositis allows reduction in morbidity of one of the therapy limiting complications of radiotherapy for cancer therapy OBJECTIVE To assess the microbiological effects of an antiseptic , non-alcohol based mouth-rinse containing chlorhexidine and cetylpyridinium chloride , in patients undergoing radiation therapy for head- and -neck cancer . STUDY DESIGN This was a parallel , double-blind , prospect i ve , r and omized clinical trial , including patients irradiated as part of the therapy of head- and -neck cancer , aged 18 - 75 , with at least 10 teeth , and willing to sign an informed consent . Cancer patients were r and omly assigned to one of the two treatments ( test mouth-rinse or a placebo ) . Three visits were scheduled ( baseline , 14 and 28 days ) . Microbiological findings were evaluated in tongue , mucosa and subgingival sample s , by means of culture . Microbiological variables were assessed by means of the Mann-Whitney , Wilcoxon and chi-square tests . RESULTS 70 patients were screened and 36 were included . The detection of C and ida species in mucosa and tongue sample s showed significant reductions in the test group . Total bacterial counts decreased in both groups from baseline to the 2-week visit , while minor changes occurred between 2 and 4 weeks ( effects on P. gingivalis , P. intermedia , C. rectus , E. corrodens ) . CONCLUSIONS Within the limitations of the small sample size , this study suggests that the use of the tested mouth-rinse may lead to improvements in microbiological parameters in patients irradiated for head- and -neck cancer Patients receiving cytotoxic antineoplastic therapy often have treatment-associated stomatitis . A 0.12 % chlorhexidine digluconate mouthrinse was evaluated ( 15 ml , three times a day ) in a prospect i ve , double-blind r and omized trial as prophylaxis against cytotoxic therapy-induced damage to oral soft tissues . Seventy subjects , forty in patients receiving high-dose chemotherapy and thirty out patients receiving high-dose head and neck radiation therapy , were evaluated . Chlorhexidine mouthrinse significantly reduced the incidence of oral mucositis in the chemotherapy group on day 14 ( p less than 0.02 ) and at 1 week follow-up on day 28 ( p less than 0.002 ) . Mucositis in the patients undergoing chemotherapy who received chlorhexidine also resolved more rapidly . Mucositis severity was significantly less compared to the control chemotherapy group on day 14 ( p less than 0.03 ) , day 21 ( p less than 0.04 ) , and on 1 week follow-up ( p less than 0.02 ) . Concomitant trends in the reduction in oral streptococci and yeast were noted in the chemotherapy group receiving chlorhexidine mouthrinse . Although no differences were observed in oral mucositis between the control and chlorhexidine groups of patients undergoing high-dose radiotherapy , similar reductions of oral microflora to those seen in the chemotherapy population were also noted for patients undergoing radiation therapy who received chlorhexidine . Although generally not significant , some increase in gram-negative bacilli was noted in the chlorhexidine-treated patients in both the chemotherapy and radiotherapy groups , but there was no correlation with increased systemic infection . Prophylactic chlorhexidine mouthrinse reduces oral mucositis and microbial burden in patients with cancer undergoing intensive chemotherapy Oral mucosal ulceration complicating bone marrow transplantation interferes with patients ' comfort , nutrition and may lead to systemic infection derived from the mouth . The mucosal injury results from epithelial damage due to the cytotoxic effects of chemotherapy and radiation conditioning as well as from superficial oropharyngeal infection . Because chlorhexidine gluconate is a broad spectrum topical antimicrobial which has been demonstrably effective in preventing oral infection and gingivitis , we performed a r and omized , placebo controlled , double-blind trial of chlorhexidine as a mouth rinse in BMT recipients to study the severity of oral mucositis and both oral and systemic infectious complications . One hundred patients were r and omly assigned to receive either chlorhexidine gluconate 0.12 % mouth rinse or placebo three times daily from the initiation ( day -8 ) of chemoradiotherapy conditioning until day + 35 post-BMT . Chlorhexidine use result ed in a trend toward improved oral hygiene index ( reduced dental plaque ) ( p = 0.06 ) but did not modify the oral mucositis . Patients using chlorhexidine developed a maximum ulceration of 18 + /- 22 % of their oral mucosa , while placebo patients ulcerated 25 + /- 31 % of the mouth . Ulcerative mucositis was significantly worse in adults compared with children , in individuals who received methotrexate for graft-versus-host disease prophylaxis , and was most prominent on non-keratinized epithelium . Overall , there was no clinical ly demonstrable additional therapeutic advantage to the use of chlorhexidine in either reducing the mucositis , controlling oral pain , facilitating oral nutrition , shortening hospital stay , or reducing oral infection with herpes simplex virus . There was a trend toward diminished oral c and idiasis in chlorhexidine users ( p = 0.06 ) . ( ABSTRACT TRUNCATED AT 250 WORDS PURPOSE To determine whether a chlorhexidine mouthwash could alleviate radiation-induced oral mucositis . PATIENTS AND METHODS Patients scheduled to receive radiation therapy to include greater than one third of the oral cavity mucosa were selected for study . Following stratification , they were r and omized in a double-blind manner to receive a chlorhexidine mouthwash or a placebo mouthwash . Both groups were then similarly evaluated for mucositis and mouthwash toxicity . RESULTS Twenty-five patients were r and omized to receive the chlorhexidine mouthwash , while 27 received the placebo mouthwash . Treatment arms were well balanced . There was a trend for more mucositis and there was substantially more toxicity ( eg , mouthwash-induced discomfort , taste alteration , and teeth staining ) on the chlorhexidine arm . CONCLUSION In contrast to the pre study hypothesis that a chlorhexidine mouthwash might provide benefit for patients receiving radiation therapy to the oral mucosa , this study provides strong evidence suggesting that a chlorhexidine mouthwash is detrimental in this clinical situation PURPOSE / OBJECTIVES To test the effectiveness of a nurse-initiated systematic oral hygiene teaching program-PRO-SELF : Mouth Aware (PSMA)-in conjunction with two mouthwashes ( 0.12 % chlorhexidine or sterile water ) in preventing chemotherapy-induced oral mucositis . DESIGN R and omized , double-blind , placebo-controlled , clinical trial . SETTING S 23 outpatient clinics and office practice s in California . SAMPLE 222 patients who were starting a cycle of mucositis-inducing chemotherapy . METHOD Participants were followed over three chemotherapy cycles . All patients were provided the PSMA program . R and om assignment to a mouthwash occurred prior to the development of oral mucositis . Research ers used the Oral Assessment Guide to assess the patients oral cavities monthly ( with the patients cycles of chemotherapy ) and when patients reported any oral changes between cycles . MAIN RESEARCH VARIABLES Type of mouthwash , incidence , days to onset , and severity of chemotherapy-induced oral mucositis . FINDINGS No significant differences existed between the two mouthwashes in regard to incidence , days to onset , and severity of mucositis . CONCLUSIONS Because chlorhexidine ( S20 per pint ) was no more effective than water , a substantial cost savings can be realized by rinsing with water . Interestingly , the PSMA program appeared to reduce the incidence of mucositis from on a prior estimate of 44 % to less than 26 % . IMPLICATION S FOR NURSING PRACTICE A nursing prescription of a systematic oral hygiene program using water as a mouth rinse is cost efficient and may be effective in preventing oral mucositis The goal of reducing oral complications during chemotherapy and bone marrow transplantation has received attention at several centers . The current r and omized study of 86 adults with leukemia treated with chemotherapy or bone marrow transplantation assessed the potential role of chlorhexidine , nystatin , and saline solution rinses to reduce the findings of oral mucositis , gingivitis , and oral infection . The results of this study did not show a reduction in mucositis with the use of these rinses . However , potential bacterial and fungal pathogens were identified less frequently in the patients using chlorhexidine rinse OBJECTIVE To assess the effects of an antiseptic , non-alcohol based mouth-rinse containing chlorhexidine and cetylpyridinium chloride , in preventing the oral complications associated to radiation therapy in head- and -neck cancer patients . STUDY DESIGN This was a parallel , double blind , prospect i ve , r and omized clinical trial . Cancer patients were r and omly assigned to one of the two treatments ( test mouth-rinse or a placebo ) . Three visits were scheduled ( baseline , 14 and 28 days ) . Different outcome variables were evaluated : mucositis , plaque and gingival indices , stimulated saliva and salivary pH. RESULTS 70 patients were screened and 36 were included . The presence and the degree of mucositis significantly increased in both groups and no significant differences were detected between groups , although the median increase in the placebo group ( 1.81 ) at 2 weeks was higher than in the test group ( 1.20 ) . CONCLUSIONS Within the limitations of the small sample size , this study suggests that the use of the tested mouth-rinse may lead to some improvements in clinical parameters in patients irradiated for head- and -neck cancer AIMS The present study was done to assess the effect of three alcohol-free mouthwashes on radiation-induced oral mucositis in patients with head and neck malignancies . MATERIAL S AND METHODS Eighty patients with head and neck malignancies , scheduled to undergo curative radiotherapy , were r and omly assigned to receive one of the three alcohol-free test mouthwashes ( 0.12 % chlorhexidine , 1 % povidone-iodine , or salt/soda ) or a control . The patients were instructed to rinse with 10 ml of the mouthwash , twice a day , for a period of 6 weeks . Mucositis was assessed at baseline and at weekly intervals during radiation therapy , using the World Health Organization criteria for grading of mucositis . The baseline demography of the four groups was matched for age , sex , stage of cancer , and whether the patient had cancer of oral or extraoral regions . A post hoc test for repeated measures was used to find the difference of mean mucositis scores between the groups at various week intervals . RESULTS Among the 76 patients who completed the study , patients in the povidone-iodine group had significantly lower mucositis scores when compared to the control group from the first week of radiotherapy . Their scores were also significantly lower when compared to the salt/soda and chlorhexidine groups from the fourth and fifth week , respectively , after radiotherapy . CONCLUSIONS This study demonstrates that use of alcohol-free povidone-iodine mouthwash can reduce the severity and delay the onset of oral mucositis due to antineoplastic radiotherapy Conditioning chemoradiotherapy damages the mucosal barrier of the mouth and throat and often produces severe oral inflammation and infection . In a prospect i ve , double-blind , r and omized study , we examined the use of a chlorhexidine digluconate mouthrinse for prophylaxis against oral mucosal complications in 51 bone marrow transplant patients . Use of chlorhexidine mouthrinse produced significant reductions in the incidence and severity of oral mucositis . Mucositis also resolved more quickly in patients receiving chlorhexidine . Concomitant reductions in total oral streptococci ( p less than 0.02-p less than 0.001 ) and oral c and ida ( p less than 0.004 ) were seen in patients using chlorhexidine . Persistent clinical oral c and idiasis ( thrush ) was observed in 15 to 27 control group patients ( 56 % ) , but only transiently in two ( 8 % ) of 24 patients who used chlorhexidine rinse ( p less than 0.001 ) . Five of 27 control group patients ( 19 % ) had c and idemia , while no c and idemia was observed in the chlorhexidine group ( p less than 0.03 ) . Three deaths from disseminated c and idiasis occurred in the placebo group ; none occurred in patients who received chlorhexidine . Prophylactic use of chlorhexidine mouthrinse produces reductions in oral soft tissue disease and oral microbial burden in patients undergoing bone marrow transplantation . The reductions in mucositis and in oral c and ida infections observed with prophylactic chlorhexidine mouthrinse represent a significant advantage for patients undergoing marrow transplantation Mucositis induced by irradiation is the \n Output:\n " }, { "from": "agent", "value": "CONCLUSIONS This systematic review found that chlorhexidine is not significantly effective in reducing the severity of mucositis ( moderate quality of evidence ) nor in preventing the incidence of mucositis ( low quality of evidence ) ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: PURPOSE To evaluate the safety and efficacy of intravenous ( IV ) sodium ferric gluconate complex ( FG ) , oral ferrous sulfate , or no iron to increase hemoglobin ( Hb ) in anemic cancer patients receiving chemotherapy and epoetin alfa . PATIENTS AND METHODS In this open-label , multicenter trial , 187 patients with chemotherapy-related anemia ( Hb < 11 g/dl ; serum ferritin > or = 100 ng/ml or transferrin saturation > or = 15 % ) scheduled to receive chemotherapy and epoetin alfa ( 40,000 U subcutaneously weekly ) were r and omized to 8 weeks of 125 mg of IV FG weekly , 325 mg of oral ferrous sulfate three times daily , or no iron . The primary outcome was a change in Hb from baseline to endpoint , first whole-blood or red blood cell transfusion , or study withdrawal . RESULTS One hundred twenty-nine patients were evaluable for efficacy ( FG , n = 41 ; oral iron , n = 44 ; no iron , n = 44 ) . Mean increase in Hb was 2.4 g/dl ( 95 % confidence interval [ CI ] , 2.1 - 2.7 ) for FG ( p = .0092 vs. oral iron ; p = .0044 vs. no iron ) , 1.6 g/dl ( 95 % CI , 1.1 - 2.1 ) for oral iron ( p = .7695 vs. no iron ) , and 1.5 g/dl ( 95 % CI , 1.1 - 1.9 ) for no iron . Hb response ( increase > or = 2 g/dl ) was 73 % for FG ( p = .0099 vs. oral iron ; p = .0029 vs. no iron ) , 46 % for oral iron ( p = .6687 vs. no iron ) , and 41 % for no iron . FG was well tolerated . CONCLUSION For cancer patients with chemotherapy-related anemia receiving epoetin alfa , FG produces a significantly greater increase in Hb and Hb response compared with oral iron or no iron , supporting more aggressive treatment with IV iron supplementation for these patients Aims Therapy with i.v . iron in patients with chronic heart failure ( CHF ) and iron deficiency ( ID ) improves symptoms , functional capacity , and quality of life . We sought to investigate whether these beneficial outcomes are independent of anaemia . Methods and results FAIR-HF r and omized 459 patients with CHF [ NYHA class II or III , LVEF ≤40 % ( NYHA II ) or ≤45 % ( NYHA III ) ] and ID to i.v . iron as ferric carboxymaltose ( FCM ) or placebo in a 2:1 ratio . We analysed the efficacy and safety according to the presence or absence of anaemia ( haemoglobin ≤120 g/L ) at baseline . Of 459 patients , 232 had anaemia at baseline ( 51 % ) . The effect of FCM on the primary endpoints of self-reported Patient Global Assessment ( PGA ) and NYHA class at week 24 was similar in patients with and without anaemia [ odds ratio ( OR ) for improvement , 2.48 vs. 2.60 , P = 0.97 for PGA and 1.90 vs. 3.39 , P = 0.51 for NYHA ) . Results were also similar for the secondary endpoints , including PGA and NYHA at weeks 4 and 12 , 6 min walk test distance , Kansas City Cardiomyopathy Question naire overall score , and European Quality of Life-5 Dimensions Visual Analogue Scale at most time points . Regarding safety , no differences were noticed in the rates of death or first hospitalization between FCM and placebo both in anaemic and in non-anaemic patients . Conclusions Treatment of ID with FCM in patients with CHF is equally efficacious and shows a similar favourable safety profile irrespective of anaemia . Iron status should be assessed in symptomatic CHF patients both with and without anaemia and treatment of ID should be considered BACKGROUND Iron deficiency may impair aerobic performance . This study aim ed to determine whether treatment with intravenous iron ( ferric carboxymaltose ) would improve symptoms in patients who had heart failure , reduced left ventricular ejection fraction , and iron deficiency , either with or without anemia . METHODS We enrolled 459 patients with chronic heart failure of New York Heart Association ( NYHA ) functional class II or III , a left ventricular ejection fraction of 40 % or less ( for patients with NYHA class II ) or 45 % or less ( for NYHA class III ) , iron deficiency ( ferritin level < 100 microg per liter or between 100 and 299 microg per liter , if the transferrin saturation was < 20 % ) , and a hemoglobin level of 95 to 135 g per liter . Patients were r and omly assigned , in a 2:1 ratio , to receive 200 mg of intravenous iron ( ferric carboxymaltose ) or saline ( placebo ) . The primary end points were the self-reported Patient Global Assessment and NYHA functional class , both at week 24 . Secondary end points included the distance walked in 6 minutes and the health-related quality of life . RESULTS Among the patients receiving ferric carboxymaltose , 50 % reported being much or moderately improved , as compared with 28 % of patients receiving placebo , according to the Patient Global Assessment ( odds ratio for improvement , 2.51 ; 95 % confidence interval [ CI ] , 1.75 to 3.61 ) . Among the patients assigned to ferric carboxymaltose , 47 % had an NYHA functional class I or II at week 24 , as compared with 30 % of patients assigned to placebo ( odds ratio for improvement by one class , 2.40 ; 95 % CI , 1.55 to 3.71 ) . Results were similar in patients with anemia and those without anemia . Significant improvements were seen with ferric carboxymaltose in the distance on the 6-minute walk test and quality -of-life assessment s. The rates of death , adverse events , and serious adverse events were similar in the two study groups . CONCLUSIONS Treatment with intravenous ferric carboxymaltose in patients with chronic heart failure and iron deficiency , with or without anemia , improves symptoms , functional capacity , and quality of life ; the side-effect profile is acceptable . ( Clinical Trials.gov number , NCT00520780 ) OBJECTIVES Anaemia is a frequent complication after cardiopulmonary bypass surgery . Iron therapy has been variably employed by medical centres over the years . In our study we test the clinical effectiveness of intravenous and oral iron supplementation in correcting anaemia , and its impact on blood transfusion requirements , in patients undergoing cardiopulmonary bypass surgery . METHODS A double-blind , r and omized , placebo-controlled clinical trial with three parallel groups of patients . Group I ( n = 54 ) : intravenous iron(III)-hydroxide sucrose complex , three doses of 100 mg/24 h during pre- and postoperative hospitalization and 1 pill/24 h of oral placebo in the same period and during 1 month after discharge . Group II ( n = 53 ) : oral ferrous fumarate iron 1 pill/24 h pre- and postoperatively and during 1 month after discharge , and intravenous placebo while hospitalized . Group III ( n = 52 ) : oral and intravenous placebo pre- and postoperatively , following the same protocol . Data were collected preoperatively , at theatre , at intensive care unit admission , before hospital discharge and 1 month later . RESULTS ( 1 ) Baseline clinical and demographic characteristics and surgical procedures were similar in the three groups ; ( 2 ) no inter-group differences were found in haemoglobin and haematocrit during the postoperative period ; ( 3 ) the intravenous iron group showed higher serum ferritin levels at hospital discharge ( 1321 ± 495 ng/ml ; P < 0.001 ) and 1 month later ( 610 ± 387 ; P < 0.001 ) compared with the other groups and ( 4 ) we did not observe statistical differences in blood transfusion requirements between the three groups . CONCLUSIONS The use of intravenous or oral iron supplementation proved ineffective in correcting anaemia after cardiopulmonary bypass and did not reduce blood transfusion requirements . [ Current Controlled Trials number : NCT01078818 ( oral and intravenous iron in patients postoperative cardiovascular surgery under EC ) ] To determine if high doses of oral iron could shorten the duration of therapy necessary to treat Fe deficiency anemia , high-dose Fe 600 mg three times per day ( given as nontoxic carbonyl Fe ) was compared with st and ard ferrous sulfate 60 mg Fe++ three times per day in a r and omized , double-blind , 3-wk trial involving 36 female blood donors with mild Fe deficiency anemia . In animal studies , both forms of Fe have similar bioavailability when administered in equal amounts . High-dose carbonyl Fe was well tolerated with gastrointestinal side effects similar those observed with st and ard FeSO4 therapy . The 10-fold larger amount of Fe result ed in a mean 1.5-fold increase in estimated Fe absorption . Both regimens corrected anemia but neither replenished storage Fe . These results suggest that the principal advantage to the use of carbonyl Fe would derive from its safety rather than from the large doses that can be given OBJECTIVE Sub clinical hypothyroidism is a health state that is associated with hypercholesterolemia , infertility , iron-deficiency anemia , and poor obstetric outcome . This article summarizes the results of a prospect i ve clinical investigation of whether treatment of sub clinical hypothyroidism and iron-deficiency anemia with a combination of levothyroxine plus iron salt would be superior to each treatment alone . METHODS In a r and omized , double-blind , active-controlled trial , 60 patients with sub clinical hypothyroidism and iron-deficiency anemia received iron salt+placebo ( 20 patients ) , levothyroxine+placebo ( 20 patients ) , or levothyroxine+iron salt ( 20 patients ) for 3 months . Change from baseline ( before ) to end of study ( after ) in hemoglobin , ferritin , and thyroid-stimulating hormone levels were compared among groups . RESULTS The increase from baseline in hemoglobin and ferritin in the levothyroxine+iron group was superior to the other groups , in which a decrease in thyroid-stimulating hormone in the 2 groups that received levothyroxine was superior to the group treated with iron salt . CONCLUSION Sub clinical hypothyroidism was investigated in iron-deficient patients with no acceptable response to iron salt alone . A combination of levothyroxine and iron salt is better than each one alone Background : The aim of this study was to compare the efficacy , safety and achievement of the target hemoglobin level ( Hb ≥10 g/dl ) in patients with preoperative anemia due to menorrhagia who received intravenous iron sucrose compared with oral iron protein succinylate for anemia management . Methods : Seventy-six patients with Hb levels < 9.0 g/dl who were scheduled to undergo surgical treatment were r and omized to receive either intravenous iron sucrose ( based on the calculated total iron deficit divided into 2 ampoule infusions intravenously 3 times a week , beginning 3 weeks before surgery ) or oral iron ( 80 mg/day of oral iron protein succinylate daily ) . Results : The intravenous iron group had higher increases in Hb ( 3.0 vs. 0.8 g/dl ; p < 0.0001 ) and ferritin levels ( 170.1 vs. 4.1 μg/l ; p < 0.0001 ) than the oral iron group . Achieving the target Hb was also higher in the intravenous iron group than in the oral iron group ( 76.7 vs. 11.5 % ; p < 0.0001 ) . There were tolerable adverse events in both groups . Conclusion : Preoperative intravenous iron sucrose administration is more effective than oral iron and is as safe as oral iron therapy in the correction of preoperative anemia due to menorrhagia 8612 Background : Patients ( pts ) with cancer receiving chemotherapy often have chemotherapy-induced anemia ( CIA ) and reduced quality of life . Darbepoetin alfa ( DA ) is an erythropoiesis-stimulating agent ( ESA ) that can effectively treat CIA when administered once every 3 weeks ( Q3W ) . In patients with CIA , limited data in the literature suggest that administration of intravenous ( IV ) iron with ESA therapy may increase clinical response . METHODS This r and omized , multicenter , open-label , 16-week study evaluated the safety and efficacy of DA 500 mcg administered Q3W using the SureClick injection device in pts with CIA ( Hb < 11 g/dL ) who received either IV iron or st and ard practice for iron administration ( oral iron or no iron ) . The dose of IV iron was 200 mcg administered either Q3W with DA Q3W or , if required , as 2 doses ( 200 mcg total ) within a 3-week period . Pts who received ≥ 1 do \n Output:\n " }, { "from": "agent", "value": "Adverse effects related to oral iron treatment included nausea , diarrhoea and constipation ; most were mild .\nThus , little evidence was found to support the use of one preparation or regimen over another .\nSubgroup analyses did not reveal consistent results ; therefore we were unable to determine whether iron is useful in specific clinical situations , or whether iron therapy might be useful for people who are receiving erythropoietin .\n• Very low- quality evidence suggests that oral iron might decrease the proportion of people who require blood transfusion , and no evidence indicates that it decreases mortality ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Study C210 was a Phase IIa , exploratory trial to assess the activity of telaprevir on hepatitis C virus ( HCV ) early viral kinetics in treatment-naïve patients infected with genotype 4 ( G4 ) HCV . Methods Patients were r and omized to receive peginterferon and ribavirin alone , telaprevir monotherapy ( T arm ) , or telaprevir in combination with peginterferon/ribavirin ( TPR arm ) for 15 days , followed by a 46- or 48-week st and ard treatment phase . The current analysis aim ed to characterize the genotype and phenotype of HCV G4 variants emerging during telaprevir treatment . Results Five of the 8 ( 62.5 % ) patients in the telaprevir ( T ) arm had viral breakthrough ( vBT ) during the investigational treatment phase ( between baseline and Day 15 ) , compared to no patients in the TPR arm . HCV G4 viral variants with a T54A/T mutation were detected in two of these patients , as well as two other patients with detectable HCV RNA at the end of telaprevir treatment . Emergence of the T54A/T mutation was associated with a 2- to 4-fold decreased susceptibility to telaprevir . All patients with vBT during the investigational treatment phase or with a T54A/T mutation achieved undetectable HCV RNA 12 or 24 weeks after end of treatment with subsequent peginterferon/ribavirin treatment . Conclusions In this analysis in G4 HCV-infected patients , more patients in the telaprevir monotherapy arm experienced vBT with resistant variants compared to none with telaprevir combination therapy . The most commonly selected mutation T54A in telaprevir-treated G4 HCV patients was previously described in the context of G1 infection . Trial registration The trial was registered with Clinical Trials.gov ( NCT00580801 ) Vaniprevir is a competitive inhibitor of the hepatitis C virus ( HCV ) NS3/4A protease that has potent anti-HCV activity in pre clinical models . This placebo-controlled dose-ranging study assessed the safety , tolerability , and antiviral efficacy of vaniprevir monotherapy in patients with genotype 1 chronic HCV infection . Treatment-naive and treatment-experienced non-cirrhotic adult patients with baseline HCV RNA > 10(6)IU/ml were r and omized to receive placebo or vaniprevir at doses of 125 mg qd , 600 mg qd , 25 mg bid , 75 mg bid , 250 mg bid , 500 mg bid , and 700 mg bid for 8 days . Forty patients ( 82.5 % male , 75 % genotype 1a ) received at least one dose of placebo or vaniprevir . After 1 week of vaniprevir , the decrease in HCV RNA from baseline ranged from 1.8 to 4.6 log₁₀IU/ml across all treatment groups , and there was a greater than dose-proportional increase in vaniprevir exposure at doses above 75 mg bid . The most commonly reported drug-related adverse events ( AEs ) were diarrhea ( n=5 ) and nausea ( n=5 ) . No pattern of laboratory or ECG abnormalities was observed , all AEs resolved during the study , and there were no discontinuations due to AEs . No serious AEs were reported . Resistance-associated amino acid variants were identified at positions R155 and D168 in patients infected with genotype 1a virus . Vaniprevir monotherapy demonstrated potent antiviral activity in patients with chronic genotype 1 HCV infection , and was generally well tolerated with no serious AEs or discontinuations due to AEs . Further development of vaniprevir , including studies in combination with other anti-HCV agents , is ongoing BACKGROUND New direct-acting antiviral agents are currently being developed to treat chronic HCV . The efficacy and safety of daclatasvir combined with peginterferon alfa-2a ( alfa-2a ) and ribavirin were assessed in a r and omized , double-blind Phase IIa study of Japanese patients with chronic HCV genotype-1 infection . METHODS Japanese patients who were treatment-naive ( n=25 ) or prior null ( n=12 ) or partial ( n=5 ) responders received once-daily daclatasvir 10 mg or 60 mg or placebo in combination with alfa-2a and ribavirin . Daclatasvir recipients with a protocol -defined response ( HCV RNA<15 IU/ml at week 4 and undetectable at week 12 ) were treated for 24 weeks ; placebo recipients and patients without a protocol -defined response were treated for 48 weeks . RESULTS Sustained virological response at 24 weeks post-treatment ( SVR24 ) was achieved by 89 % and 100 % of treatment-naive patients receiving daclatasvir 10 mg and 60 mg , respectively , versus 75 % in placebo recipients . Virological failure was more frequent in prior non-responder patients , with 50 % and 78 % achieving SVR24 in daclatasvir 10 mg and 60 mg groups , respectively . Adverse events occurred with similar frequency among treatment groups and were consistent with the adverse event profile of alfa-2a/ribavirin alone . The most commonly reported adverse events included pyrexia , alopecia , anaemia , lymphopenia , neutropenia , pruritus and diarrhoea . Three patients discontinued treatment due to anaemia . CONCLUSIONS Daclatasvir combined with alfa-2a/ribavirin in treatment-naive patients showed greater efficacy than alfa-2a/ribavirin alone and was generally well tolerated . The 60-mg dose of daclatasvir achieved the highest rates of SVR24 in both treatment-naive and non-responder population s and will be evaluated in a Phase III clinical trial BACKGROUND Faldaprevir ( BI 201335 ) and deleobuvir ( BI 207127 ) are direct-acting antiviral agents under development for the treatment of chronic HCV infection . This article describes the final results of the Phase Ib SOUND-C1 study that evaluated the interferon-free oral combination of faldaprevir , deleobuvir and ribavirin in 32 treatment-naive patients infected with HCV genotype 1 . METHODS Patients were r and omized to receive deleobuvir 400 mg ( n=15 ) or 600 mg ( n=17 ) three times daily plus faldaprevir 120 mg once daily and weight-based ribavirin for 4 weeks . Interferon-free therapy was followed by response-guided faldaprevir plus pegylated interferon-α2a/ribavirin to week 24 or 48 . RESULTS At week 4 , 73 % ( 11/15 ) and 100 % ( 17/17 ) of patients in the deleobuvir 400 mg and 600 mg groups achieved HCV RNA<25 IU/ml , respectively . During interferon-free treatment , virological breakthrough was reported in one patient and re-increase of HCV RNA in one patient . Both patients were successfully treated with interferon-containing therapy . The rate of sustained virological response 24 weeks after completion of treatment was 73 % ( 11/15 ) in the deleobuvir 400 mg group and 94 % ( 16/17 ) in the 600 mg group . During faldaprevir plus pegylated interferon-α2a/ribavirin treatment , the most common adverse events were pruritus ( 38 % of patients ) , rash ( 31 % ) and asthenia ( 31 % ) ; these were severe in approximately 3 % of patients . CONCLUSIONS Potent antiviral activity and favourable safety of the treatment regimen were demonstrated . Furthermore , the results suggest that patients with breakthrough at week 4 may be rescued with an interferon-containing regimen . Clinical trials.gov number NCT01132313 BACKGROUND & AIMS MK-7009 ( vaniprevir ) is a non-covalent competitive inhibitor of the hepatitis C virus ( HCV ) NS3/4A protease . This report presents the primary analysis results ( safety and sustained viral response ) of a phase 2b study of MK-7009 given in combination with peginterferon ( PegIFN ) alfa2a 180 μg weekly and ribavirin ( RBV ) 1000 - 1200 mg/day , for 24 - 48 weeks to non-cirrhotic patients who have failed previous PegIFN and RBV treatment . METHODS We present results of a r and omized , placebo-controlled , double-blind study of MK-7009 administered for 24 - 48 weeks in combination with PegIFN and RBV in 4 regimens to at least 40 patients per arm . Stratification by prior response to PegIFN and RBV was as follows : null response , partial response , breakthrough and relapse . HCV RNA was determined by Roche Cobas Taqman with a lower limit of detection ( LLoD ) of 10 IU/ml and a lower limit of quantification ( LLoQ ) of 25 IU/ml . RESULTS SVR24 in patients on MK-7009+PegIFN and ribavirin ( P/R ) was statistically superior to placebo+P/R in all treatment groups ( p<0.001 ) . MK-7009 at 300 mg b.i.d . and 600 mg b.i.d . is generally well tolerated for use for up to 48 weeks of therapy . Patients in MK-7009 regimens had higher rates of gastrointestinal adverse events as compared to control ( mostly mild to moderate ) . There were no significant differences in rates of anemia and rash between the MK-7009 regimens and control . CONCLUSIONS In conclusion , patients treated with MK-7009 plus P/R experienced significant improvement in SVR compared to P/R control in a population of GT 1 experienced patients BACKGROUND Patients with genotype 1 hepatitis C virus ( HCV ) who do not have a sustained response to therapy with peginterferon alfa and ribavirin have a low likelihood of success with retreatment . METHODS We r and omly assigned patients with HCV genotype 1 who had not had a sustained virologic response after peginterferon alfa-ribavirin therapy to one of four treatment groups : 115 patients to the T12PR24 group , receiving telaprevir ( 1125-mg loading dose , then 750 mg every 8 hours ) for 12 weeks and peginterferon alfa-2a ( 180 microg per week ) and ribavirin ( 1000 or 1200 mg per day , according to body weight ) for 24 weeks ; 113 patients to the T24PR48 group , receiving telaprevir for 24 weeks and peginterferon alfa-2a and ribavirin for 48 weeks ( at the same doses as in the T12PR24 group ) ; 111 patients to the T24P24 group , receiving telaprevir and peginterferon alfa-2a for 24 weeks ( at the same doses as in the T12PR24 group ) ; and 114 patients to the PR48 ( or control ) group , receiving peginterferon alfa-2a and ribavirin for 48 weeks ( at the same doses as in the T12PR24 group ) . The primary end point was sustained virologic response ( undetectable HCV RNA levels 24 weeks after the last dose of study drugs ) . RESULTS The rates of sustained virologic response in the three telaprevir groups--51 % in the T12PR24 group , 53 % in the T24PR48 group , and 24 % in the T24P24 group -- were significantly higher than the rate in the control group ( 14 % ; P<0.001 , P<0.001 , and P=0.02 , respectively ) . Response rates were higher among patients who had previously had relapses than among nonresponders . One of the most common adverse events in the telaprevir groups was rash ( overall , occurring in 51 % of patients , with severe rash in 5 % ) . Discontinuation of study drugs because of adverse events was more frequent in the telaprevir groups than in the control group ( 15 % vs. 4 % ) . CONCLUSIONS In HCV-infected patients in whom initial peginterferon alfa and ribavirin treatment failed , retreatment with telaprevir in combination with peginterferon alfa-2a and ribavirin was more effective than retreatment with peginterferon alfa-2a and ribavirin alone . ( Clinical Trials.gov number , NCT00420784 . A r and om-primed complementary DNA library was constructed from plasma containing the uncharacterized non-A , non-B hepatitis ( NANBH ) agent and screened with serum from a patient diagnosed with NANBH . A complementary DNA clone was isolated that was shown to encode an antigen associated specifically with NANBH infections . This clone is not derived from host DNA but from an \n Output:\n " }, { "from": "agent", "value": "The evidence for our main outcomes of interest come from short-term trials , and we are unable to determine the effect of long-term treatment with DAAs .\nThe rates of hepatitis C morbidity and mortality observed in the trials are relatively low and we are uncertain as to how DAAs affect this outcome .\nOverall , there is very low quality evidence that DAAs on the market or under development do not influence serious adverse events .\nThere is insufficient evidence to judge if DAAs have beneficial or harmful effects on other clinical outcomes for chronic HCV .\nSimeprevir may have beneficial effects on risk of serious adverse event .\nIn all remaining analyses , we could neither confirm nor reject that DAAs had any clinical effects .\nDAAs may reduce the number of people with detectable virus in their blood , but we do not have sufficient evidence from r and omised trials that enables us to underst and how SVR affects long-term clinical outcomes ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background : Dysphagia is common after stroke . The onset time of swallowing rehabilitation following stroke has an important role in the recovery of dysphagia and preventing of its complications , but it was either highly variable or was not stated in previous trials . The aim of this study was investigation effects of onset time of swallowing therapy on recovery from dysphagia following stroke . Methods : Sixty dysphagia patients due to stroke range of age 60 - 74 ( 67.1 ± 3.8 ) , participated in this r and omized clinical trial study . The patients allocated in Early , Medium and Late groups , on the base of initiation of swallowing therapy after the stroke . After basic clinical and video fluoroscopic swallowing study assessment s , traditional swallowing therapy was initiated 3 times per week for 3 months . The outcome measures were North-Western dysphagia patient check sheet , functional oral intake scale , video fluoroscopy , and frequency of pneumonia . Statistical analysis was done by repeated measure ANOVA , Bonferroni and χ2 tests . Results : Three groups of patients in terms of demographic and clinical characteristics were similar in the pre-treatment P > 0.050 . Onset time of swallowing therapy after stroke was effective on swallowing recovery on the main outcome variables . So that in first group patients , recovery was rather than other groups P < 0.050 . Furthermore , the frequency of pneumonia in the early group was less than other groups and in the early group no patients experienced pneumonia P = 0.002 . Conclusion : Our data suggested that early interventions for dysphagia in stroke have an important role in recovery from dysphagia and prevention of complications like aspiration pneumonia Background — Outpatient cardiac rehabilitation ( CR ) decreases mortality rates but is underutilized . Current median time from hospital discharge to enrollment is 35 days . We hypothesized that an appointment within 10 days would improve attendance at CR orientation . Methods and Results — At hospital discharge , 148 patients with a nonsurgical qualifying diagnosis for CR were r and omized to receive a CR orientation appointment either within 10 days ( early ) or at 35 days ( st and ard ) . The primary end point was attendance at CR orientation . Secondary outcome measures were attendance at ≥1 exercise session , the total number of exercise sessions attended , completion of CR , and change in exercise training workload while in CR . Average age was 60±12 years ; 56 % of participants were male and 49 % were black , with balanced baseline characteristics between groups . Median time ( 95 % confidence interval ) to orientation was 8.5 ( 7–13 ) versus 42 ( 35 to NA [ not applicable ] ) days for the early and st and ard appointment groups , respectively ( P<0.001 ) . Attendance rates at the orientation session were 77 % ( 57/74 ) versus 59 % ( 44/74 ) in the early and st and ard appointment groups , respectively , which demonstrates a significant 18 % absolute and 56 % relative improvement ( relative risk , 1.56 ; 95 % confidence interval , 1.03–2.37 ; P=0.022 ) . The number needed to treat was 5.7 . There was no difference ( P>0.05 ) in any of the secondary outcome measures , but statistical power for these end points was low . Safety analysis demonstrated no difference between groups in CR-related adverse events . Conclusions — Early appointments for CR significantly improve attendance at orientation . This simple technique could potentially increase initial CR participation nationwide . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT01596036 BACKGROUND Triage liaison physicians ( TLPs ) have been employed in overcrowded emergency departments ( EDs ) ; however , their effectiveness remains unclear . OBJECTIVES To evaluate the implementation of TLP shifts at an academic tertiary care adult ED using comprehensive outcome reporting . METHODS A six-week TLP clinical research project was conducted between December 9 , 2005 , and February 9 , 2006 . A TLP was deployed for nine hours ( 11 AM to 8 PM ) daily to initiate patient management , assist triage nurses , answer all medical consult or transfer calls , and manage ED administrative matters . The study was divided into three two-week blocks ; within each block , seven days were r and omized to TLP shifts and the other seven to control shifts . Outcomes included patient length of stay , proportion of patients who left without complete assessment , staff satisfaction , and episodes of ambulance diversion . RESULTS TLPs assessed a median of 14 patients per shift ( interquartile range , 13 - 17 ) , received 15 telephone calls per shift ( interquartile range , 14 - 20 ) , and spent 17 - 81 minutes per shift consulting on the telephone . The number of patients and their age , gender , and triage score during the TLP and control shifts were similar . Overall , length of stay was decreased by 36 minutes compared with control days ( 4:21 vs. 4:57 ; p = 0.001 ) . Left without complete assessment cases decreased from 6.6 % to 5.4 % ( a 20 % relative decrease ) during the TLP coverage . The ambulance wait time and number of episodes of ambulance diversion were similar on TLP and control days . CONCLUSIONS A TLP improved important outcomes in an overcrowded ED and could improve delivery of emergency medical care in similar tertiary care EDs Study Design . A single blind r and omized controlled trial comparing two models of care for patients with acute simple low back pain . Objectives . To compare two research -based models of care for acute low back pain and investigate the effect of the timing of physical intervention . Summary of Background Data . National guidelines offer conflicting information on the delivery of physical treatment in the management of acute low back pain . The guidelines suggest two different models of care . Direct comparisons between these models are lacking in the literature . The present study aims to compare these approaches to the management of acute low back pain . Methods . Among 804 referred patients , 102 subjects met the specific admission criteria and were r and omly assigned to an “ assess/advise/treat ” group or an “ assess/advise/wait ” group . The intervention consisted of biopsychosocial education , manual therapy , and exercise . Assessment of short-term outcome enables comparison to be made between intervention and advice to stay active . Assessment of long-term outcome enables comparison to be made between early and late intervention . Study outcomes of reported pain ( Visual Analogue Scale ) , functional disability ( the Rol and and Morris Disability Question naire ) , mood ( Modified Zung Self Rated Depression Score , Modified Somatic Perception Question naire , State-Trait Anxiety Inventory ) , general health ( Euroqol ) , and quality of life ( Short Form 36 ) were assessed at baseline , 6 weeks , 3 months , and 6 months . Results . At 6 weeks , the assess/advise/treat group demonstrated greater improvements in disability , mood , general health , and quality of life than patients in the assess/advise/wait group ( P < 0.05 ) . Disability and pain were not significantly different between the groups at long-term follow up ( P > 0.05 ) . However , mood , general health , and quality of life remained significantly better in the assess/advise/treat group ( P < 0.05 ) . Conclusions . At short-term , intervention is more effective than advice on staying active , leading to more rapid improvement in function , mood , quality of life , and general health . The timing of intervention affects the development of psychosocial features . If treatment is provided later , the same psychosocial benefits are not achieved . Therefore , an assess/advise/treat model of care seems to offer better outcomes than an assess/advise/wait model of care Objectives : To assess whether initial patient consult by senior clinicians reduces numbers of patients waiting to be seen as an indirect measure of waiting time throughout the emergency department ( ED ) . Methods : An emergency medicine consultant and a senior ED nurse ( G or F grade ) , known as the IMPACT team , staffed the triage area for four periods of four hours per week , Monday to Friday between 9 am to 5 pm for three months between December 2001 and February 2002 when staffing levels permitted . Patients normally triaged by a nurse in this area instead had an early consultation with the IMPACT team . Data were collected prospect ively on all patients seen by the IMPACT team . The number of patients waiting to be seen ( for triage , in majors and in minors ) was assessed every two hours during the IMPACT sessions and at corresponding times when no IMPACT team was operational . Results : There was an overall reduction in the number of patients waiting to be seen in the department from 18.3 to 5.5 ( p<0.0001 ) at formal two hourly assessment s. The largest difference was seen in minors . Of the patients seen at triage by the IMPACT team , 48.9 % were discharged home immediately after assessment and treatment . With the IMPACT team present , no patient waited more than four hours for initial clinical consult . Conclusions : By using a senior clinical team for initial patient consultation , the numbers of patients waiting fell dramatically throughout the ED . Many patients can be effectively treated and discharged after initial consult by the IMPACT team Objective To evaluate the effectiveness of a structured group education programme on biomedical , psychosocial , and lifestyle measures in people with newly diagnosed type 2 diabetes . Design Multicentre cluster r and omised controlled trial in primary care with r and omisation at practice level . Setting 207 general practice s in 13 primary care sites in the United Kingdom . Participants 824 adults ( 55 % men , mean age 59.5 years ) . Intervention A structured group education programme for six hours delivered in the community by two trained healthcare professional educators compared with usual care . Main outcome measures Haemoglobin A1c levels , blood pressure , weight , blood lipid levels , smoking status , physical activity , quality of life , beliefs about illness , depression , and emotional impact of diabetes at baseline and up to 12 months . Main results Haemoglobin A1c levels at 12 months had decreased by 1.49 % in the intervention group compared with 1.21 % in the control group . After adjusting for baseline and cluster , the difference was not significant : 0.05 % ( 95 % confidence interval −0.10 % to 0.20 % ) . The intervention group showed a greater weight loss : −2.98 kg ( 95 % confidence interval −3.54 to −2.41 ) compared with 1.86 kg ( −2.44 to −1.28 ) , P=0.027 at 12 months . The odds of not smoking were 3.56 ( 95 % confidence interval 1.11 to 11.45 ) , P=0.033 higher in the intervention group at 12 months . The intervention group showed significantly greater changes in illness belief scores ( P=0.001 ) ; directions of change were positive indicating greater underst and ing of diabetes . The intervention group had a lower depression score at 12 months : mean difference was −0.50 ( 95 % confidence interval −0.96 to −0.04 ) ; P=0.032 . A positive association was found between change in perceived personal responsibility and weight loss at 12 months ( β=0.12 ; P=0.008 ) . Conclusion A structured group education programme for patients with newly diagnosed type 2 diabetes result ed in greater improvements in weight loss and smoking cessation and positive improvements in beliefs about illness but no difference in haemoglobin A1c levels up to 12 months after diagnosis . Trial registration Current Controlled Trials IS RCT N17844016 Background : Although effective treatment of depressed patients requires regular follow-up contacts and symptom monitoring , an efficient method for assessing treatment outcome is lacking . We investigated responsiveness to treatment , reproducibility , and minimal clinical ly important difference of the Patient Health Question naire-9 ( PHQ-9 ) , a st and ard instrument for diagnosing depression in primary care . Methods : This study included 434 intervention subjects from the IMPACT study , a multisite treatment trial of late-life depression ( 63 % female , mean age 71 years ) . Changes in PHQ-9 scores over the course of time were evaluated with respect to change scores of the SCL-20 depression scale as well as 2 independent structured diagnostic interviews for depression during a 6-month period . Test-retest reliability and minimal clinical ly important difference were assessed in 2 subgroups of patients who completed the PHQ-9 twice exactly 7 days apart . Results : The PHQ-9 responsiveness as measured by effect size was significantly greater than the SCL-20 at 3 months ( −1.3 versus −0.9 ) and equivalent at 6 months ( −1.3 versus −1.2 ) . With respect to structured diagnostic interviews , both the PHQ-9 and the SCL-20 change scores accurately discriminated patients with persistent major depression , partial remission , and full remission . Test-retest reliability of the PHQ-9 was excellent , and its minimal clinical ly important difference for individual change , estimated as 2 st and ard errors of measurement , was 5 points on the 0 to 27 point PHQ-9 scale . Conclusions : Well-vali date d as a diagnostic measure , the PHQ-9 has now proven to be a responsive and reliable measure of depression treatment outcomes . Its responsiveness to treatment coupled with its brevity makes the PHQ-9 an attractive tool for gauging response to treatment in individual patient care as well as in clinical research Study Design An inception cohort design was used in which 421 patients were evaluated systematic ally with a st and ard battery of psychosocial assessment tests ( Structured Interview for DSM-III-R Diagnosis , Minnesota Multiphasic Personality Inventory , and Million Visual Pain Analog Scale ) within 6 weeks of acute back pain onset . Objectives \n Output:\n " }, { "from": "agent", "value": "There was low-level evidence that reduced wait time is associated with moderate improvement in workplace participation for patients seeking care for musculoskeletal conditions ; and moderate improvement in exercise tolerance for patients referred to cardiac rehabilitation .\nThere was inconsistent evidence that improvements in quality of life , patient satisfaction and psychological symptoms may be associated with shorter wait times .\nPain , function and physical activity outcomes were not associated with wait time .\nConclusions This review found low-level evidence suggesting an association between early access to community outpatient services and improvement of some patient outcomes .\nSpecifically , shorter wait times from referral to first visit for musculoskeletal pain services may improve patient work participation .\nShorter wait times for cardiac rehabilitation may improve patient exercise capacity .\nThe effects of a short wait time for other patient conditions and patient outcomes , including quality of life , psychological symptoms and patient experience , are inconclusive ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE To test the hypothesis that missing primary care follow-up plans in the discharge summary is associated with higher 30-day readmissions . STUDY DESIGN This retrospective cohort study included pediatric patients discharged from Mattel Children 's Hospital , University of California , Los Angeles between July 2008 and July 2010 . Exclusions included deaths , transfers , neonatal discharges , stays under 24 hours , and patients over 18 years of age . Bivariate and propensity weighted multivariate logistic regressions tested relationships between 30-day readmission and patient demographics , illness severity , and documentation of primary care provider ( PCP ) follow-up plans at discharge . RESULTS There were 7794 index discharges ( representing 5056 unique patients ) , with 1457 readmissions within 30 days ( 18.7 % ) . Average length of stay was 6.3 days . Being 15 - 18 years old , ( OR 1.42 [ 1.02 - 1.96 ] ) , having public insurance ( OR 1.48 [ 1.20 - 1.83 ] ) , or having higher All-Patient Refined Diagnosis-Related Group severity scores ( for severity = 4 vs 1 , OR 6.88 [ 4.99 - 9.49 ] ) was associated with increased odds of 30-day readmission . After adjusting for insurance status , Asian ( OR 1.46 [ 1.01 - 2.12 ] ) but not Black or Hispanic , race/ethnicity was associated with greater odds of readmission . Fifteen percent of 172 medical records from a r and omly selected month in 2010 documented PCP follow-up plans . After adjusting for demographics , length of stay and severity , documenting PCP follow-up plans was associated with significantly increased odds of 30-day readmission ( OR 4.52 [ 1.01 - 20.31 ] ) . CONCLUSION Readmission rates are complex quality measures , and documenting primary care follow-up may be associated with higher rather than lower 30-day readmissions . Additional studies are needed to underst and the inpatient-outpatient transition BACKGROUND Patients with complex care needs who require care across different health care setting s are vulnerable to experiencing serious quality problems . A care transitions intervention design ed to encourage patients and their caregivers to assert a more active role during care transitions may reduce rehospitalization rates . METHODS R and omized controlled trial . Between September 1 , 2002 , and August 31 , 2003 , patients were identified at the time of hospitalization and were r and omized to receive the intervention or usual care . The setting was a large integrated delivery system located in Colorado . Subjects ( N = 750 ) included community-dwelling adults 65 years or older admitted to the study hospital with 1 of 11 selected conditions . Intervention patients received ( 1 ) tools to promote cross-site communication , ( 2 ) encouragement to take a more active role in their care and to assert their preferences , and ( 3 ) continuity across setting s and guidance from a \" transition coach . \" Rates of rehospitalization were measured at 30 , 90 , and 180 days . RESULTS Intervention patients had lower rehospitalization rates at 30 days ( 8.3 vs 11.9 , P = .048 ) and at 90 days ( 16.7 vs 22.5 , P = .04 ) than control subjects . Intervention patients had lower rehospitalization rates for the same condition that precipitated the index hospitalization at 90 days ( 5.3 vs 9.8 , P = .04 ) and at 180 days ( 8.6 vs 13.9 , P = .046 ) than controls . The mean hospital costs were lower for intervention patients ( $ 2058 ) vs controls ( $ 2546 ) at 180 days ( log-transformed P = .049 ) . CONCLUSION Coaching chronically ill older patients and their caregivers to ensure that their needs are met during care transitions may reduce the rates of subsequent rehospitalization OBJECTIVE To determine whether parent-reported quality of primary care was associated with subsequent health care use for children with special health care needs . DESIGN Secondary analysis of prospect ively collected data . SETTING The 2004 - 2005 and 2005 - 2006 Medical Expenditure Panel Survey panels . PARTICIPANTS A total of 1591 children with special health care needs . MAIN EXPOSURES Composite measures for family centeredness of care , timeliness of care , and realized access derived from the Consumer Assessment of Healthcare Providers and Systems survey . MAIN OUTCOME MEASURES Rates of parent-reported emergency department visits ( nonurgent and urgent ) and hospitalizations . Only encounters occurring after completion of the Consumer Assessment of Healthcare Providers and Systems survey were assessed . Weighted multivariate Poisson regression analyses , yielding incident rate ratios , were used for analysis . RESULTS Of the parents of the 1591 children included , 68.3 % rated family centeredness , 51.5 % rated timeliness , and 80.4 % rated realized access as high quality . Low- quality family centeredness was associated with higher rates ( incident rate ratio , 2.24 ; 95 % confidence interval , 1.32 - 3.80 ) of nonurgent emergency department visits compared with corresponding rates associated with high- quality family centeredness . There were no associations between quality -of-care domains and rates of urgent emergency department visits . For privately insured children , low- quality family centeredness was associated with higher rates ( incident rate ratio , 3.87 ; 95 % confidence interval , 1.23 - 12.13 ) of hospitalizations compared with corresponding rates associated with high- quality family-centered care . For publicly insured children , no significant associations were found . CONCLUSIONS Parent-reported , low- quality family centeredness was associated with higher rates of subsequent nonurgent emergency department visits and hospitalizations among children with special health care needs . These findings highlight family-centered care as a critical area for primary care intervention to reduce potentially preventable health care use IMPORTANCE Socioeconomic and behavioral factors can negatively influence posthospital outcomes among patients of low socioeconomic status ( SES ) . Traditional hospital personnel often lack the time , skills , and community linkages required to address these factors . OBJECTIVE To determine whether a tailored community health worker ( CHW ) intervention would improve posthospital outcomes among low-SES patients . DESIGN , SETTING , AND PARTICIPANTS A 2-armed , single-blind , r and omized clinical trial was conducted between April 10 , 2011 , and October 30 , 2012 , at 2 urban , academically affiliated hospitals . Of 683 eligible general medical in patients ( ie , low-income , uninsured , or Medicaid ) that we screened , 237 individuals ( 34.7 % ) declined to participate . The remaining 446 patients ( 65.3 % ) were enrolled and r and omly assigned to study arms . Nearly equal percentages of control and intervention group patients completed the follow-up interview ( 86.6 % vs 86.9 % ) . INTERVENTIONS During hospital admission , CHWs worked with patients to create individualized action plans for achieving patients ' stated goals for recovery . The CHWs provided support tailored to patient goals for a minimum of 2 weeks . MAIN OUTCOMES AND MEASURES The prespecified primary outcome was completion of primary care follow-up within 14 days of discharge . Prespecified secondary outcomes were quality of discharge communication , self-rated health , satisfaction , patient activation , medication adherence , and 30-day readmission rates . RESULTS Using intention-to-treat analysis , we found that intervention patients were more likely to obtain timely posthospital primary care ( 60.0 % vs 47.9 % ; P = .02 ; adjusted odds ratio [ OR ] , 1.52 ; 95 % CI , 1.03 - 2.23 ) , to report high- quality discharge communication ( 91.3 % vs 78.7 % ; P = .002 ; adjusted OR , 2.94 ; 95 % CI , 1.5 - 5.8 ) , and to show greater improvements in mental health ( 6.7 vs 4.5 ; P = .02 ) and patient activation ( 3.4 vs 1.6 ; P = .05 ) . There were no significant differences between groups in physical health , satisfaction with medical care , or medication adherence . Similar proportions of patients in both arms experienced at least one 30-day readmission ; however , intervention patients were less likely to have multiple 30-day readmissions ( 2.3 % vs 5.5 % ; P = .08 ; adjusted OR , 0.40 ; 95 % CI , 0.14 - 1.06 ) . Among the subgroup of 63 readmitted patients , recurrent readmission was reduced from 40.0 % vs 15.2 % ( P = .03 ; adjusted OR , 0.27 ; 95 % CI , 0.08 - 0.89 ) . CONCLUSIONS AND RELEVANCE Patient-centered CHW intervention improves access to primary care and quality of discharge while controlling recurrent readmissions in a high-risk population . Health systems may leverage the CHW workforce to improve posthospital outcomes by addressing behavioral and socioeconomic drivers of disease . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01346462 ABSTRACT BACKGROUND Patient activation is linked to better health outcomes and lower rates of health service utilization . The role of patient activation in the rate of hospital readmission within 30 days of hospital discharge has not been examined . METHODS A secondary analysis using data from the Project RED-LIT r and omized controlled trial conducted at an urban safety net hospital . Data from 695 English-speaking general medical inpatient subjects were analyzed . We used an adapted , eight-item version of the vali date d Patient Activation Measure ( PAM ) . Total scores were categorized , according to st and ardized methods , as one of four PAM levels of activation : Level 1 ( lowest activation ) through Level 4 ( highest activation ) . The primary outcome measure was total 30-day post-discharge hospital utilization , defined as total emergency department ( ED ) visits plus hospital readmissions including observation stays . Poisson regression was used to control for confounding . RESULTS Of the 695 subjects , 67 ( 9.6 % ) were PAM Level 1 , 123 ( 17.7 % ) were Level 2 , 193 ( 27.8 % ) were Level 3 , and 312 ( 44.9 % ) were Level 4 . Compared with highly activated patients ( PAM Level 4 ) , a higher rate of 30-day post-discharge hospital utilization was observed for patients at lower levels of activation ( PAM Level 1 , incident rate ratio [ IRR ] 1.75 , 95 % CI,1.18 to 2.60 ) and ( PAM Level 2 , IRR 1.50 , 95 % CI 1.06 to 2.13 ) . The rate of returning to the hospital among patients at PAM Level 3 was not statistically different than patients with PAM Level 4 ( IRR 1.30 , 95 % CI , 0.94 to 1.80 ) . The rate ratio for PAM Level 1 was also higher compared with Level 4 for ED use alone ( 1.68(1.07 to 2.63 ) ) and for hospital readmissions alone ( 1.93 [ 1.22 to 3.06 ] ) . CONCLUSION Hospitalized adult medical patients in an urban academic safety net hospital with lower levels of Patient Activation had a higher rate of post-discharge 30-day hospital utilization OBJECTIVES To evaluate an integrated telehealth intervention ( Integrated Telehealth Education and Activation of Mood ( I-TEAM ) ) to improve chronic illness ( congestive heart failure , chronic obstructive pulmonary disease ) and comorbid depression in the home healthcare setting . DESIGN R and omized controlled trial . SETTING Hospital-affiliated home healthcare setting . PARTICIPANTS Medically frail older homebound individuals ( N = 102 ) . INTERVENTION The 3-month intervention consisted of integrated telehealth chronic illness and depression care , with a telehealth nurse conducting daily telemonitoring of symptoms , body weight , and medication use ; providing eight weekly sessions of problem-solving treatment for depression ; and providing for communication with participants ' primary care physicians , who also prescribed antidepressants . Control participants were allocated to usual care with in-home nursing plus psychoeducation ( UC+P ) . MEASUREMENTS The two groups were compared at baseline and 3 and 6 months after baseline on clinical measures ( depression , health , problem-solving ) and 12 months after baseline on health utilization ( readmission , episodes of care , and emergency department ( ED ) visits ) . RESULTS Depression scores were 50 % lower in the I-TEAM group than in the UC+P group at 3 and 6 months . Those who received the I-TEAM intervention significantly improved their problem-solving skills and self-efficacy in managing their medical condition . The I-TEAM group had significantly fewer ED visits ( P = .01 ) but did not have significantly fewer days in the hospital at 12 months after baseline . CONCLUSION Integrated telehealth care for older adults with chronic illness and comorbid depression can reduce symptoms and postdischarge ED use in home health setting OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised \n Output:\n " }, { "from": "agent", "value": "Postsurgical patients , those with neurologic disorders , and those with medical devices had higher preventable hospitalization rates , as did those with public insurance and nonwhite race/ethnicity .\nPassive smoke exposure , nonadherence to medications , and lack of follow-up after discharge were additional risks .\nHospitalizations for ambulatory care sensitive conditions were less common in more complex patients .\nPatients receiving home visits , care coordination , chronic care-management , and continuity across setting s had fewer preventable hospitalizations .\nRisk of bias was moderate due primarily to limited controlled experimental design s. Reductions in hospital use among CMC might be possible ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVES : Though the greatest proportion of irritable bowel syndrome ( IBS ) patients report a mixed bowel pattern ( IBS-Mixed ) , no available therapies have been rigorously evaluated in this subgroup . This study aim ed to evaluate the efficacy and safety of the 5-HT4 agonist tegaserod in women with IBS-Mixed and IBS with constipation ( IBS-C ) . METHODS : This prospect i ve , double-blind , r and omized , placebo-controlled , multicenter study was conducted in 100 centers in North America , South America , and Europe . Women with IBS-Mixed or IBS-C received tegaserod 6 mg or placebo twice daily . The primary efficacy variable was the patient 's assessment of satisfactory relief over the 4-wk treatment period . The proportion of patients reporting satisfactory relief for ≥3 of 4 treatment weeks ( 75 % rule ) and individual IBS symptoms were assessed . RESULTS : In total , 661 women were r and omized ( IBS-Mixed 324 , IBS-C 337 ) . Baseline symptom assessment s identified clear differences between the two cohorts . Tegaserod provided significant improvement in satisfactory relief of IBS symptoms over 4 wk ( OR 1.75 , 95 % CI 1.35–2.25 , P < 0.001 ) in both IBS-Mixed and IBS-C patients . Using the 75 % rule , 52.3 % of tegaserod-receiving IBS-M patients and 43.3 % of IBS-C patients were responders ( vs 36.3 , OR 1.88 , 95 % CI 1.16–3.04 , P < 0.010 ; and 28.9 , OR 1.90 , 95 % CI 1.19–3.05 , P < 0.008 for placebo , respectively ) . The most frequent adverse events leading to study discontinuation in tegaserod-treated patients were diarrhea ( 1.5 % ) and abdominal pain ( 0.9 % ) . Overall 7 % of IBS-C patients reported diarrhea compared to 12 % of IBS-Mixed ( placebo 2.4 % , 1.8 % , respectively ) . CONCLUSIONS : Tegaserod is effective in treating overall IBS symptoms in patients with IBS-Mixed and OBJECTIVES : To assess long-term safety and efficacy of alosetron in women with severe , chronic diarrhea-predominant IBS and in a subset having more frequent urgency ( i.e. , bowel urgency at least 10 of 14 days during screening ) . METHODS : R and omized patients received either alosetron 1 mg ( n = 351 ) or placebo ( n = 363 ) twice daily during a 48-wk , double-blind study . The primary endpoint was the 48-wk average rate of adequate relief of IBS pain and discomfort . Secondary endpoints included 48-wk average satisfactory control rates of urgency , stool frequency , stool consistency , and bloating . Other efficacy endpoints were average monthly adequate relief and urgency control rates and impact of provided rescue medication . RESULTS : Alosetron-treated patients had significantly greater 48-wk average adequate relief ( p = 0.01 ) and urgency control ( p < 0.001 ) rates , regardless of rescue medication use , compared with placebo . Results in subjects with more frequent urgency were more robust than those in the overall population ( p = 0.005 ) . In weeks without rescue medication use , satisfactory control rates for stool frequency and stool consistency were significantly greater in alosetron-treated patients than placebo . Alosetron-treated patients had significantly greater adequate relief than placebo-treated patients ( p < 0.05 ) in 9 of 12 months and significantly greater urgency control ( p < 0.001 ) in all months . Adequate relief and urgency control were maintained throughout the treatment . Adverse events and serious adverse events were similar between treatment groups , except for constipation . Neither ischemic colitis nor serious events related to bowel motor dysfunction was reported . CONCLUSIONS : Long-term use of alosetron is effective and well-tolerated in women with chronic , diarrhea-predominant IBS , including those with more frequent urgency : No currently available treatment provides consistent relief of irritable bowel syndrome . Colonic sensory and motor function are modulated partly through 5HT3‐receptors Herbal remedies , particularly peppermint , have been reported to be helpful in controlling symptoms of irritable bowel syndrome ( IBS ) . We conducted a r and omized double-blind placebo-controlled study on 90 out patients with IBS . Subjects took one capsule of enteric-coated , delayed-release peppermint oil ( Colpermin ) or placebo three times daily for 8 weeks . We visited patients after the first , fourth , and eighth weeks and evaluated their symptoms and quality of life . The number of subjects free from abdominal pain or discomfort changed from 0 at week 0 to 14 at week 8 in the Colpermin group and from 0 to 6 in controls ( P < 0.001 ) . The severity of abdominal pain was also reduced significantly in the Colpermin group as compared to controls . Furthermore , Colpermin significantly improved the quality of life . There was no significant adverse reaction . Colpermin is effective and safe as a therapeutic agent in patients with IBS suffering from abdominal pain or discomfort OBJECTIVES : Bowel urgency is one of the most bothersome symptoms for nonconstipated IBS patients . The efficacy of alosetron in control of bowel urgency and Global Improvement of IBS symptoms were evaluated in a multicenter double-blind , r and omized , placebo-controlled study . METHODS : Female IBS patients with lack of satisfactory control of bowel urgency were r and omized 2:1 to alosetron 1 mg twice daily or placebo treatment groups . The primary endpoint was the proportion of days with satisfactory control of bowel urgency during the 12-wk treatment period and 2-wk follow-up period . Secondary endpoints included IBS Global Improvement ( responder defined as patient-reported moderate or substantial improvement in IBS symptoms ) and improvements in bowel function ( stool frequency , consistency , and sensation of incomplete evacuation ) . RESULTS : A total of 801 women were r and omized to the alosetron ( n = 532 ) or placebo groups ( n = 269 ) . Physicians classified 98 % of patients with diarrhea-predominant IBS . Patients treated with alosetron had a significantly greater proportion of days with satisfactory control of urgency compared to placebo for the treatment period ( 73 % vs 57 % , p < 0.001 ) . A significantly greater number of patients treated with alosetron were IBS Global Improvement responders compared to placebo at week 12 ( 76 % vs 44 % , p < 0.001 ) . IBS Global Improvement responders had more days with satisfactory control of urgency at week 12 ( 88 % vs 48 % ) as well as firmer stools , fewer stools/day , and fewer days with incomplete evacuation compared with nonresponders . Alosetron-treated patients showed improvements in bowel functions compared to placebo-treated patients . Constipation was the most commonly reported adverse event . CONCLUSIONS : Alosetron is effective at managing bowel urgency in women with diarrhea-predominant IBS . The IBS Global Improvement assessment correlated with improvements in bowel function and may be a useful tool in future IBS clinical trials Are meta-analyses the brave new world , or are the critics of such combined analyses right to say that the biases inherent in clinical trials make them uncombinable ? Negative trials are often unreported , and hence can be missed by meta-analysts . And how much heterogeneity between trials is acceptable ? A recent major criticism is that large r and omised trials do not always agree with a prior meta- analysis . Neither individual trials nor meta-analyses , reporting as they do on population effects , tell how to treat the individual patient . Here we take a more rounded approach to meta-analyses , arguing that their strengths outweigh their weaknesses , although the latter must not be brushed aside A double-blind controlled therapeutic trial of factorial design was used to study the therapeutic effects of lorazepam , hyoscine butylbromide , and ispaghula husk in 12 r and omised blocks of eight patients with the irritable bowel syndrome ( IBS ) . Each of the three agents caused a sustained symptomatic improvement in some of the patients , although only with ispaghula was the difference between the real and dummy preparation statistically significant . When the eight possible combinations of treatment were analysed none of the 12 patients who received only dummy preparations of the three agents had maintained any improvement over the three months of the trial . Seven patients improved among the 12 who received potent preparations of all three agents , and between four and six patients improved in the groups receiving one or two of the potent preparations . These therapeutic results , though far from perfect , show that the types of drug commonly used to treat IBS are of some value and may be additive in their effects . Similar combinations of other therapeutic agents may be more effective , but it will be possible to determine this only by carrying out factorial therapeutic trials Background / objective In order to follow the most recent developments and recommendations in trial methodology for drug evaluation in patients with irritable bowel syndrome , we performed an extended analysis of a large clinical trial from a previously published study of otilonium bromide , using an assessment that integrates the key symptoms of irritable bowel syndrome . Material s and methods A large-scale clinical trial with a double-blind , placebo-controlled , parallel-group study design was conducted in 378 patients , treated for 15 weeks with the recommended st and ard dose of 40 mg otilonium bromide or placebo three times daily . The study was based on the collection of 12 single efficacy endpoints . The new efficacy assessment was based on the data reported by the patients . Rather than demonstrating score differences between the treatment groups of the study , we carried out an assessment that integrates the most frequent symptoms reported ( pain frequency and intensity , presence of meteorism and distension ) by the patient . Results The rate of response to treatment within 2–4 months ( the primary efficacy outcome measure ) was significantly higher in the otilonium bromide group ( 36.9 % ) than in the placebo group ( 22.5 % ; P = 0.007 ) . In each month of treatment , the rate of monthly response was higher in the otilonium bromide group as compared to the placebo group ( P < 0.05 ) . The total monthly and weekly responses to the single endpoints ( intensity and frequency of pain and discomfort , meteorism/abdominal distension , severity of diarrhoea or constipation and mucus in the stool ) were significantly more frequent in the group treated with otilonium bromide than in the placebo-treated group , with differences ranging from 10 % to 20 % . The subgroup analysis of the intestinal habits endpoint indicates that patients with diarrhoea have an additional benefit . Conclusion The present re-evaluation of a previously published study confirms that otilonium bromide is more effective than placebo for the treatment of irritable bowel syndrome , being very efficient in relieving pain and discomfort BACKGROUND AND AIM Previous studies with cisapride reported conflicting results in patients with constipation-predominant irritable bowel syndrome ( IBS ) . To gain further evidence , this r and omized double-blind study was carried out . METHODS Eighty-two symptomatic out patients were r and omized to receive either 5 mg oral cisapride or placebo three times daily for a period of 12 weeks . In patients without satisfactory improvement after 4 weeks , the dose was doubled . Symptom evaluation used visual analog scales ( VAS ) and the investigators ' global assessment . RESULTS After 4 weeks , in 18 ( 45 % ) cisapride and 24 ( 57 % ) placebo patients the dose was doubled because of insufficient improvement of symptoms . The mean VAS score for patients ' global rating of IBS symptoms at baseline was 67.5 mm for cisapride versus 70.7 mm for placebo , and improved to 38.4 mm versus 44.5 mm after 12 weeks of treatment . Investigators rated the overall effect of therapy as good or excellent in 70 % of the cisapride and 50 % of the placebo group . Neither these nor further efficacy parameter differences reached statistical significance . CONCLUSIONS These results indicate that the effect of 15 - 30 mg cisapride daily on symptoms of constipation-predominant IBS is not significantly superior to placebo . During the 12 week treatment of this trial cisapride proved to be safe and tolerable BACKGROUND : A r and omized , double blind , placebo-controlled dose-ranging study was conducted to assess the efficacy of alosetron in men with diarrhea-predominant irritable bowel syndrome ( IBS ) . METHODS : Six hundred and sixty-two men were r and omized to treatment with alosetron 0.5 , 1.0 , 2.0 , 4.0 mg , or placebo twice daily for 12 wk , followed by a 4-wk posttreatment period . Adequate relief of IBS pain and discomfort during week 5–12 of the treatment phase was the primary endpoint ; secondary endpoints included bowel urgency , stool frequency , and consistency , incomplete evacuation , bloating , and abdominal pain or discomfort . RESULTS : Subjects ranked urgency and abdominal pain as their most bothersome IBS symptoms . \n Output:\n " }, { "from": "agent", "value": "Placebo response rates across RCTs of pharmacological therapies in IBS were high ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Advances in technology allowed the development of a novel smoking cessation program delivered by video messages sent to mobile phones . This social cognitive theory-based intervention ( called “ STUB IT ” ) used observational learning via short video diary messages from role models going through the quitting process to teach behavioral change techniques . Objective The objective of our study was to assess the effectiveness of a multimedia mobile phone intervention for smoking cessation . Methods A r and omized controlled trial was conducted with 6-month follow-up . Participants had to be 16 years of age or over , be current daily smokers , be ready to quit , and have a video message-capable phone . Recruitment targeted younger adults predominantly through radio and online advertising . Registration and data collection were completed online , prompted by text messages . The intervention group received an automated package of video and text messages over 6 months that was tailored to self-selected quit date , role model , and timing of messages . Extra messages were available on dem and to beat cravings and address lapses . The control group also set a quit date and received a general health video message sent to their phone every 2 weeks . Results The target sample size was not achieved due to difficulty recruiting young adult quitters . Of the 226 r and omized participants , 47 % ( 107/226 ) were female and 24 % ( 54/226 ) were Maori ( indigenous population of New Zeal and ) . Their mean age was 27 years ( SD 8.7 ) , and there was a high level of nicotine addiction . Continuous abstinence at 6 months was 26.4 % ( 29/110 ) in the intervention group and 27.6 % ( 32/116 ) in the control group ( P = .8 ) . Feedback from participants indicated that the support provided by the video role models was important and appreciated . Conclusions This study was not able to demonstrate a statistically significant effect of the complex video messaging mobile phone intervention compared with simple general health video messages via mobile phone . However , there was sufficient positive feedback about the ease of use of this novel intervention , and the support obtained by observing the role model video messages , to warrant further investigation . Trial registration Australian New Zeal and Clinical Trials Registry Number : ACTRN12606000476538 ; http://www.anzctr.org.au/trial_view.aspx?ID=81688 ( Archived by WebCite at http://www.webcitation.org/5umMU4sZi Background Web-based and mobile health interventions ( also called “ Internet interventions ” or \" eHealth/mHealth interventions \") are tools or treatments , typically behaviorally based , that are operationalized and transformed for delivery via the Internet or mobile platforms . These include electronic tools for patients , informal caregivers , healthy consumers , and health care providers . The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement was developed to improve the suboptimal reporting of r and omized controlled trials ( RCTs ) . While the CONSORT statement can be applied to provide broad guidance on how eHealth and mHealth trials should be reported , RCTs of web-based interventions pose very specific issues and challenges , in particular related to reporting sufficient details of the intervention to allow replication and theory-building . Objective To develop a checklist , dubbed CONSORT-EHEALTH ( Consoli date d St and ards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth ) , as an extension of the CONSORT statement that provides guidance for authors of eHealth and mHealth interventions . Methods A literature review was conducted , followed by a survey among eHealth experts and a workshop . Results A checklist instrument was constructed as an extension of the CONSORT statement . The instrument has been adopted by the Journal of Medical Internet Research ( JMIR ) and authors of eHealth RCTs are required to su bmi t an electronic checklist explaining how they addressed each subitem . Conclusions CONSORT-EHEALTH has the potential to improve reporting and provides a basis for evaluating the validity and applicability of eHealth trials . Subitems describing how the intervention should be reported can also be used for non- RCT evaluation reports . As part of the development process , an evaluation component is essential ; therefore , feedback from authors will be solicited , and a before-after study will evaluate whether reporting has been improved Background Mobile phone-based psychological interventions enable real time self-monitoring and self-management , and large-scale dissemination . However , few studies have focussed on mild-to-moderate symptoms where public health need is greatest , and none have targeted work and social functioning . This study reports outcomes of a CONSORT-compliant r and omised controlled trial ( RCT ) to evaluate the efficacy of myCompass , a self-guided psychological treatment delivered via mobile phone and computer , design ed to reduce mild-to-moderate depression , anxiety and stress , and improve work and social functioning . Method Community-based volunteers with mild-to-moderate depression , anxiety and /or stress ( N = 720 ) were r and omly assigned to the myCompass program , an attention control intervention , or to a waitlist condition for seven weeks . The interventions were fully automated , without any human input or guidance . Participants ’ symptoms and functioning were assessed at baseline , post-intervention and 3-month follow-up , using the Depression , Anxiety and Stress Scale and the Work and Social Adjustment Scale . Results Retention rates at post-intervention and follow-up for the study sample were 72.1 % ( n = 449 ) and 48.6 % ( n = 350 ) respectively . The myCompass group showed significantly greater improvement in symptoms of depression , anxiety and stress and in work and social functioning relative to both control conditions at the end of the 7-week intervention phase ( between-group effect sizes ranged from d = .22 to d = .55 based on the observed means ) . Symptom scores remained at near normal levels at 3-month follow-up . Participants in the attention control condition showed gradual symptom improvement during the post-intervention phase and their scores did not differ from the myCompass group at 3-month follow-up . Conclusions The myCompass program is an effective public health program , facilitating rapid improvements in symptoms and in work and social functioning for individuals with mild-to-moderate mental health problems . Trial registration Australian New Zeal and Clinical Trials Registry ACTRN Background Prevention of the onset of depression in adolescence may prevent social dysfunction , teenage pregnancy , substance abuse , suicide , and mental health conditions in adulthood . New technologies allow delivery of prevention programs scalable to large and disparate population s. Objective To develop and test the novel mobile phone delivery of a depression prevention intervention for adolescents . We describe the development of the intervention and the results of participants ’ self-reported satisfaction with the intervention . Methods The intervention was developed from 15 key messages derived from cognitive behavioral therapy ( CBT ) . The program was fully automated and delivered in 2 mobile phone messages/day for 9 weeks , with a mixture of text , video , and cartoon messages and a mobile website . Delivery modalities were guided by social cognitive theory and marketing principles . The intervention was compared with an attention control program of the same number and types of messages on different topics . A double-blind r and omized controlled trial was undertaken in high schools in Auckl and , New Zeal and , from June 2009 to April 2011 . Results A total of 1348 students ( 13–17 years of age ) volunteered to participate at group sessions in schools , and 855 were eventually r and omly assigned to groups . Of these , 835 ( 97.7 % ) self-completed follow-up question naires at postprogram interviews on satisfaction , perceived usefulness , and adherence to the intervention . Over three-quarters of participants viewed at least half of the messages and 90.7 % ( 379/418 ) in the intervention group reported they would refer the program to a friend . Intervention group participants said the intervention helped them to be more positive ( 279/418 , 66.7 % ) and to get rid of negative thoughts ( 210/418 , 50.2%)—significantly higher than proportions in the control group . Conclusions Key messages from CBT can be delivered by mobile phone , and young people report that these are helpful . Change in clinician-rated depression symptom scores from baseline to 12 months , yet to be completed , will provide evidence on the effectiveness of the intervention . If proven effective , this form of delivery may be useful in many countries lacking widespread mental health services but with extensive mobile phone coverage . Clinical Trial Australia New Zeal and Clinical Trials Registry ( ACTRN ) : 12609000405213 ; http://www.anzctr.org.au/trial_view.aspx?ID=83667 ( Archived by WebCite at http://www.webcitation.org/64aueRqOb Objective To evaluate the impacts of using SMS on improving laboratory test levels and Knowledge , Attitude , Practice ( KAP ) and Self Efficacy ( SE ) of patients with type 2 diabetes mellitus ( DM ) in Iran . Material s and methods In this r and omized controlled trial study , a total of 81 type 2 diabetes patients were r and omly assigned into two groups exp . group ( n = 43 ) and cont . group ( n = 38 ) . Only exp . group received 4 messages weekly consisted of diet , exercise , medication taking and . The research ers provided the intervention for 12 weeks . Data were collected with results of laboratory tests and KAP , SE reliable and valid question naires and demographic characteristics list . Data gathering at the baseline of the study and after 3 months intervention and was analyzed by SPSS11.5 software using descriptive and inferential statistics methods . Results The results of this study showed that exp . group compared with cont . group improved significantly in HbA1C ( p = 0.024 ) , LDL ( p = 0.019 ) , cholesterol ( p = 0.002 ) , BUN ( p ≤ 0.001 ) , micro albumin ( p ≤ 0.001 ) , knowledge ( p ≤ 0.001 ) , practice ( p ≤ 0.001 ) and self efficacy ( p ≤ 0.001 ) . Conclusion The finding of this study demonstrate the effectiveness of intervention using SMS via mobile phone in the management of type 2 diabetes mellitus ( DM ) . Thus , further studies are recommended for wide usage of distance education with mobile phone utilization Background — Indirect evidence shows that alerting users with clinical decision support systems seems to change behavior more than requiring users to actively initiate the system . However , r and omized trials comparing these methods in a clinical setting are lacking . We studied the effect of both alerting and on-dem and decision support with respect to screening and treatment of dyslipidemia based on the guidelines of the Dutch College of General Practitioners . Methods and Results — In a clustered r and omized trial design , 38 Dutch general practice s ( 77 physicians ) and 87 886 of their patients ( 39 433 men 18 to 70 years of age and 48 453 women 18 to 75 years of age ) who used the ELIAS electronic health record participated . Each practice was assigned to receive alerts , on-dem and support , or no intervention . We measured the percentage of patients screened and treated after 12 months of follow-up . In the alerting group , 65 % of the patients requiring screening were screened ( relative risk versus control=1.76 ; 95 % confidence interval , 1.41 to 2.20 ) compared with 35 % of patients in the on-dem and group ( relative risk versus control=1.28 ; 95 % confidence interval , 0.98 to 1.68 ) and 25 % of patients in the control group . In the alerting group , 66 % of patients requiring treatment were treated ( relative risk versus control=1.40 ; 95 % confidence interval , 1.15 to 1.70 ) compared with 40 % of patients ( relative risk versus control=1.19 ; 95 % confidence interval , 0.94 to 1.50 ) in the on-dem and group and 36 % of patients in the control group . Conclusion — The alerting version of the clinical decision support systems significantly improved screening and treatment performance for dyslipidemia by general practitioners Background and Aims Internet-based cognitive-behavioral therapy ( iCBT ) for social anxiety disorder has been found effective , as attested by independently conducted r and omized controlled trials in four language s. The study aim is to test the efficacy of an iCBT program in a culture where it was not tested before ( i.e. Romania ) . Methods Participants ( n = 76 ) were recruited , screened and r and omized to either a nine-week guided iCBT or a wait-list control group in April and May 2012 . Self-report measures were collected before ( April 2012 ) and after the intervention ( July 2012 ) , as well as six months later ( January 2013 ) . Although social anxiety was assessed with multiple measures , the Liebowitz Social Anxiety Scale - Self Report version ( LSAS-SR ) and Social Phobia Inventory ( SPIN ) were used as the primary outcome measures . Results A significant difference with a large between-group effect size in favor of iCBT was found ( Cohen´s d = 1.19 for LSAS-SR and d = 1.27 for SPIN ) . Recovery rates show that 36.8 % ( n = 14 ) in the treatment group score below the SPIN clinical cut-off compared to only 2.6 % ( n = 1 ) in the wait-list control group . Post-intervention clinical interviews also revealed that 34.2 % ( n = 13 ) of the treatment group was completely recovered ( full remission ) while additionally 36.8 % ( n = 14 ) retained some social anxiety symptoms ( partial remission \n Output:\n " }, { "from": "agent", "value": "We also confirmed that RCTs are valuable tools for assessing the effectiveness , acceptability , safety , privacy , appropriateness , satisfaction , performance , usefulness and adherence ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND The aim of the present study was to evaluate the efficacy of alpha-human atrial natriuretic peptide ( hANP ) in cardiac surgery under cardiopulmonary bypass ( CPB ) . METHODS AND RESULTS A prospect i ve r and omized study was conducted with 150 patients who underwent scheduled coronary artery bypass grafting to compare a group of patients receiving 0.02 microg x kg(-1 ) x min(-1 ) of hANP from the initiation of CPB with a group not receiving hANP . Hemodynamics , levels of atrial and brain natriuretic peptides ( BNP ) , angiotensin-II and aldosterone , renin activity , and left ventricular ( LV ) function were examined . The hANP group showed significantly lower renin activity and lower levels of angiotensin-II and aldosterone during the early postoperative period , compared with the non-hANP group . The incidence of postoperative ventricular arrhythmia and the postoperative peak level of creatine kinase-MB were significantly lower in the hANP group . BNP at 1 month after surgery and measures of LV function were also significantly lower in the hANP group . CONCLUSIONS Low-dose continuous infusion of hANP during cardiac surgery not only had a compensatory effect for the imperfections of CPB during the early postoperative period but also an inhibitory effect on postoperative LV remodeling and a reduction in ischemia/reperfusion injury . hANP should be part of the postoperative care for cardiac surgery BACKGROUND We evaluated the effects of human atrial natriuretic peptide ( hANP ) during cardiopulmonary bypass ( CPB ) . METHODS Forty patients undergoing coronary artery bypass grafting were investigated . A group of patients given hANP for 24 hours from the start of CPB ( hANP group ) was compared with a non-hANP group . Parameters examined were hemodynamics , urine volume , dosage of furosemide , respiratory index , pleural effusion , ANP , cyclic guanosine monophosphate , renin activity ( renin ) , angiotensin-II , aldosterone , and glomerular filtration rate . RESULTS Central venous pressure , systemic vascular resistance index , and pulmonary vascular resistance index were significantly lower in the hANP group than in the non-hANP group . The hANP group showed significantly higher levels of ANP , cyclic guanosine monophosphate , glomerular filtration rate , and respiratory index , and significantly lower levels of renin , angiotensin-II , aldosterone , and pleural effusion , as compared with the non-hANP group . The dosage of furosemide was significantly lower and the urine volume was significantly larger in the hANP group . CONCLUSIONS hANP can satisfactorily compensate for the shortcomings of CPB by decreasing the peripheral vascular resistance , suppressing the renin-angiotensin-aldosterone system , and exerting a strong diuretic effect Atrial natriuretic factor ( ANF ) ameliorates renal damage in animal models of acute ischemic renal failure . Consequently , ANF could blunt acute tubular necrosis related to ischemia that occurs frequently in cadaveric renal transplants . Ten pairs of cadaveric kidneys were transplanted into 20 recipients . Paired recipients received either alpha-human ANF ( hANF ) or vehicle alone in a prospect i ve , double-blind protocol . Upon revascularization of the allograft , either hANF or vehicle was administered intravenously as a 50-micrograms bolus , followed by a 4-h infusion ( 0.1 microgram/kg/min ) . Glomerular filtration rate ( [125I]iothalamate clearance ) was measured between 4 and 7 days posttransplant and again between 14 and 21 days posttransplant . Serum creatinine was measured daily when patients were in the hospital , then twice weekly as patients were examined in the outpatient clinic . Between the groups , there was no significant difference in age of the recipients or donors , cold ischemia time , or histocompatibility leukocyte antigen match . Infusion of hANF had no adverse effects . When subjects receiving hANF were compared with those treated with vehicle alone , there were no significant differences in serum creatinine or glomerular filtration rate . Three hANF and four vehicle recipients required dialysis postoperatively . At 1 month posttransplant , 19 of 20 patients had functioning allografts ; an allograft from one hANF recipient never functioned . It was concluded that hANF , when given by the protocol of this study , had no beneficial effect on the outcome of cadaveric renal transplantation in humans This study was performed to investigate the effects of atrial natriuretic peptide ( ANP ) and mannitol on renal blood flow ( RBF ) and radiocontrast-induced nephropathy ( RCIN ) in human subjects with chronic renal failure . ANP preserves glomerular filtration rate or RBF ( or both ) in severe animal models of acute renal failure . Radiocontrast is known to substantially decrease RBF and can induce acute renal failure . Twenty consecutive patients with chronic renal failure ( 60 % with diabetes ) were r and omized in a prospect i ve , double-blind fashion to receive either ANP ( 50 micrograms bolus , then 1 microgram/min infusion ) or mannitol ( 15 % at 100 ml/hr ) for 2 hours before and during cardiac catheterization with diatrizoate . Baseline serum creatinine level ( ANP 2.4 + /- 0.7 mg/dl , mannitol 2.5 + /- 0.8 mg/dl ) , medications , and quantity of radiocontrast were similar in both groups . Direct measurements of RBF were made with thermodilution catheters placed in the left renal vein . RBF rose significantly ( p less than 0.05 ) , to 198 % of baseline at 15 minutes and 166 % of baseline at 65 minutes in the group receiving ANP and remained stable in the group receiving mannitol . ANP levels rose significantly from baseline at 5 , 15 , 65 and 120 minutes in both groups ( p less than 0.05 ) . Acute renal failure defined as a 0.5 mg/dl rise of creatinine within 24 hours of cardiac catheterization , developed only in patients with diabetes mellitus and was similar in both experimental groups ( ANP , 50 % ; mannitol , 30 % ) . Only patients with diabetes mellitus responded with an increase in RBF after a 5-minute infusion of either ANP or mannitol ( diabetes , 165 % + /- 28 % baseline ; no diabetes , 96 % + /- 8 % baseline ) ( p less than 0.05 ) . In conclusion , RBF was maintained or increased despite administration of radiocontrast , a documented renal vasoconstrictor . Patients with diabetes mellitus had a renal vasodilatory response to drug infusion . Acute renal failure occurred to a similar extent in both groups . Plasma ANP levels rose significantly in both groups . Mannitol may induce ANP release , thus contributing to mannitol 's renal effects Acute renal failure is a serious problem following heart transplantation . In first uncontrolled clinical trials , Urodilatin revealed beneficial effects in the prophylaxis and therapy of acute renal failure following heart and liver transplantation . Here , we present the first r and omized , placebo-controlled , double-blind study on 24 patients following heart transplantation to investigate whether prophylactic i.v . Urodilatin infusion can prevent acute renal failure requiring renal replacement therapy . Postoperative drug management was characterized by intravenous application of high furosemide , cyclosporine , and vancomycin doses . Urodilatin infusion was started postoperatively with a dose of 40 ng / kg bw / min for 6 days . 6 of the 12 patients in the Urodilatin group and 6 of the 12 patients in the placebo group had a stable diuresis ( 3 - 4 l / day ) during the study period of 6 days . In contrast , the remaining 6 patients of each group developed oliguria / anuria and required subsequent hemofiltration / hemodialysis . Cumulative duration of hemofiltration ( 88 + /- 7.39 hours in the placebo treated patients versus 44 + /- 5.35 hours in the Urodilatin treated patients , p < 0 . 05 ) as well as frequency of hemodialysis ( 3.0 + /- 0.49 times in the placebo group vs 1.2 + /- 0.29 times in the Urodilatin group , p < 0 . 05 ) were significantly reduced using Urodilatin . Mean arterial blood pressure was stable during the Urodilatin infusion period and was not different to that observed in placebo patients . We conclude that Urodilatin does not reduce the incidence of acute renal failure and the subsequent requirement for hemofiltration / hemodialysis in our patient population , but seems to reduce the duration of hemofiltration and frequency of hemodialysis compared to the placebo group Summary Renal failure after heart transplantation ( HTx ) still remains a serious problem , especially when cyclosporin A is used for immunosuppression in the early postoperative therapy . To preserve good renal function without reducing immunosuppressive cyclosporin A treatment , we administered urodilatin ( CDD/ANP-95 - 126 ) in a long-term , low-dose infusion in addition to the usual medication after heart transplantation . From November 1990 to June 1991 , 51 patients ( 46 male and 5 female ; mean age 48 years ) were treated with a 620 ng/kg bw·min infusion for 96 h after HTx . The renal function and hemodynamic parameters of these urodilatin-treated patients were compared in this sequential study with 40 patients ( 33 male and 7 female ; mean age 49 years ) who had undergone HTx previously from May to November , 1990 , as controls . In this phase IIa study , both groups did not differ significantly with respect to age , sex , indication for HTx , and preoperative renal function . In comparison with controls patients treated with urodilatin had a significantly better renal function : a reduction in the peak plasma creatinine ( PC values day 4 : 1.5 ± 0.11 vs. 2.19 ± 0.19 mg/dl ; P = 0.002 ) , a lower peak serum urea ( SU values day 4 : 109 ± 8 vs. 154.7 ± 8.94 mg/dl ; P = 0.0036 ) , and a lower incidence of hemodialysis ( 6 % vs. 10 % ) were observed . Adequate diuresis was maintained in spite of the reduction of furosemide by more than 60 % ( P = 0.005 ) on each day of urodilatin infusion in comparison with controls . The mean central venous pressure was significantly lower by about 50 % ( P = 0.02 ) during the administration of urodilatin in spite of reduced vasodilator medication with nitroglycerin . From this phase IIa study , we may conclude that urodilatin could be an important drug in intensive care treatment . For patients undergoing HTx , this peptide seems to be indicated for the improvement of renal function and cardiovascular status , especially in postoperative therapy using high-dose cyclosporin A treatment Many therapeutic measures have been employed to prevent or at least ameliorate postoperative renal impairment following liver transplantation . Recent clinical phase II studies have demonstrated that the new natriuretic peptide urodilatin has beneficial effects on renal function following heart and liver transplantation . The present study reports the first prospect i ve r and omized placebo-controlled trial of prophylactic urodilatin administration following liver transplantation . Seventy consecutive recipients of primary liver transplants were included in the study following r and omization , and 33 patients continuously received urodilatin at a dose of 20 ng/kg/min for 7 d. The remaining 37 patients received a placebo infusion for the same time period . The course of serum creatinine and urea did not differ between the two groups nor did the daily urine production . However , the urodilatin group showed a higher preoperative median serum creatinine and a significant reduction on days 1 and 2 , whereas this observation was not made in the placebo group . Furthermore , less furosemide was administered to the patients in the urodilatin group during the first 2 d. The incidence of postoperative hemodialysis and the number of treatments did not differ between the groups either ( urodilatin group 4 , vs. placebo group 6 and 22 for both groups , respectively ) . Side effects of the urodilatin therapy were not detected . The prophylactic low-dose urodilatin administration result ed in a trend towards amelioration of the renal function , but did not result in significant differences between the two experimental groups . Further studies , using higher doses , will be required to define the value of urodilatin for prevention of renal impairment after liver transplantation Objective Imbalance in the renal medullary oxygen supply/dem and relationship can cause hypoxic medullary damage and ischemic acute renal failure . Human atrial natriuretic peptide ( h-ANP ) increases glomerular filtration rate in clinical acute renal failure . This would increase renal oxygen consumption due to increased tubular load of sodium . Loop diuretics are commonly used in acute renal failure . Data on the effects of loop diuretics on glomerular \n Output:\n " }, { "from": "agent", "value": "For the treatment of established AKI , ANP , particularly in high doses , was associated with a trend toward increased mortality and more adverse events .\nAnalysis of the existing literature suggests ANP might be associated with beneficial clinical effects when administered in patients undergoing major surgery such as cardiovascular surgery ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objectives To test the inter-rater reliability of the RoB tool applied to Physical Therapy ( PT ) trials by comparing ratings from Cochrane review authors with those of blinded external review ers . Methods R and omized controlled trials ( RCTs ) in PT were identified by search ing the Cochrane Data base of Systematic Review s for meta- analysis of PT interventions . RoB assessment s were conducted independently by 2 review ers blinded to the RoB ratings reported in the Cochrane review s. Data on RoB assessment s from Cochrane review s and other characteristics of review s and trials were extracted . Consensus assessment s between the two review ers were then compared with the RoB ratings from the Cochrane review s. Agreement between Cochrane and blinded external review ers was assessed using weighted kappa ( κ ) . Results In total , 109 trials included in 17 Cochrane review s were assessed . Inter-rater reliability on the overall RoB assessment between Cochrane review authors and blinded external review ers was poor ( κ = 0.02 , 95%CI : −0.06 , 0.06 ] ) . Inter-rater reliability on individual domains of the RoB tool was poor ( median κ = 0.19 ) , ranging from κ = −0.04 ( “ Other bias ” ) to κ = 0.62 ( “ Sequence generation ” ) . There was also no agreement ( κ = −0.29 , 95%CI : −0.81 , 0.35 ] ) in the overall RoB assessment at the meta- analysis level . Conclusions Risk of bias assessment s of RCTs using the RoB tool are not consistent across different research groups . Poor agreement was not only demonstrated at the trial level but also at the meta- analysis level . Results have implication s for decision making since different recommendations can be reached depending on the group analyzing the evidence . Improved guidelines to consistently apply the RoB tool and revisions to the tool for different health areas are needed Objective : The aim of this study was to develop and evaluate a pedagogical tool to enhance the underst and ing of a checklist that evaluates reports of nonpharmacological trials ( CLEAR NPT ) . Design : Paired r and omised controlled trial . Participants : Clinicians and systematic review ers . Interventions : We developed an Internet-based computer learning system ( ICLS ) . This pedagogical tool used many examples from published r and omised controlled trials to demonstrate the main coding difficulties encountered when using this checklist . R and omised participants received either a specific Web-based training with the ICLS ( intervention group ) or no specific training . Outcome measures : The primary outcome was the rate of correct answers compared to a criterion st and ard for coding a report of r and omised controlled trials with the CLEAR NPT . Results : Between April and June 2006 , 78 participants were r and omly assigned to receive training with the ICLS ( 39 ) or no training ( 39 ) . Participants trained by the ICLS did not differ from the control group in performance on the CLEAR NPT . The mean paired difference and corresponding 95 % confidence interval was 0.5 ( −5.1 to 6.1 ) . The rate of correct answers did not differ between the two groups regardless of the CLEAR NPT item . Combining both groups , the rate of correct answers was high or items related to allocation sequence ( 79.5 % ) , description of the intervention ( 82.0 % ) , blinding of patients ( 79.5 % ) , and follow-up schedule ( 83.3 % ) . The rate of correct answers was low for items related to allocation concealment ( 46.1 % ) , co- interventions ( 30.3 % ) , blinding of outcome assessors ( 53.8 % ) , specific measures to avoid ascertainment bias ( 28.6 % ) , and intention-to-treat analysis ( 60.2 % ) . Conclusions : Although we showed no difference in effect between the intervention and control groups , our results highlight the gap in knowledge and urgency for education on important aspects of trial conduct UNLABELLED We describe our experience of using a modified version of the Cochrane risk of bias ( RoB ) tool for r and omised and non-r and omised comparative studies . OBJECTIVES To assess time to complete RoB assessment . To assess inter-rater agreement . To explore the association between RoB and treatment effect size METHODS Cochrane risk of bias assessment was performed on a sample of full text primary reports included in a systematic review comparing operative techniques for radical prostatectomy . Inter-rater agreement was assessed using the kappa statistic . RESULTS Twenty-four studies were judged as high overall RoB , 13 were judged as low RoB and 11 were unclear . The weighted Kappa value was 0.35 indicating fair agreement . The median ( range ) time taken to rate each study was 30 min ( 10 - 49 ) . The effect estimate for all studies was 0.61 ( 95 % credible interval ( CrI ) 0.46 - 0.83 ) and 0.73 ( 95 % CrI 0.29 - 1.75 ) for low risk studies . CONCLUSIONS Although the process was time consuming , using a modified version of the RoB tool proved useful for demonstrating conservative effect estimates . That we only achieved a fair agreement between review ers demonstrates the urgent need for further validation to improve inter-rater agreement . We suggest additional RoB levels could improve inter-rater reliability Overwhelming evidence shows the quality of reporting of r and omised controlled trials ( RCTs ) is not optimal . Without transparent reporting , readers can not judge the reliability and validity of trial findings nor extract information for systematic review s. Recent method ological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects . Such systematic error is seriously damaging to RCTs , which are considered the gold st and ard for evaluating interventions because of their ability to minimise or avoid bias . A group of scientists and editors developed the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to improve the quality of reporting of RCTs . It was first published in 1996 and up date d in 2001 . The statement consists of a checklist and flow diagram that authors can use for reporting an RCT . Many leading medical journals and major international editorial groups have endorsed the CONSORT statement . The statement facilitates critical appraisal and interpretation of RCTs . During the 2001 CONSORT revision , it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports . A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement . After an expert meeting in January 2007 , the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement . This up date improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition , such as selective outcome reporting bias . This explanatory and elaboration document-intended to enhance the use , underst and ing , and dissemination of the CONSORT statement-has also been extensively revised . It presents the meaning and rationale for each new and up date d checklist item providing examples of good reporting and , where possible , references to relevant empirical studies . Several examples of flow diagrams are included . The CONSORT 2010 Statement , this revised explanatory and elaboration document , and the associated website ( www.consort-statement.org ) should be helpful re sources to improve reporting of r and omised trials Three years ago , we founded this journal focusing on publishing systematic review s , systematic review protocol s , and associated method ological development papers . Systematic review s , which developed in the social sciences in the 1970s , began to gain rapid momentum during the 1990s in response to concerns by policymakers and clinicians about the scientific validity of the prevailing paradigm of traditional narrative review s written by authoritative experts . What distinguished systematic review s was the use of formal explicit methods , in other words pre-specification , of what exactly was the question to be answered , how evidence was search ed for and assessed , and how it was synthesized in order to reach the conclusion . Importantly , these formal methods were described as part of the review itself in a Methods section . In turn , these methods themselves became the subject of hypothesis-testing studies , as investigators sought how best to search for evidence , assess studies for quality or risk of bias , determine under what conditions meta- analysis was justified , and how to best determine and characterize our confidence in the conclusions . The results of these hypothesis-testing studies led over time to improvements in the methods we use for systematic review s. Thus , systematic review s and this journal are part of an ever-evolving process whose foundations are rooted in the scientific method . Today , new forms of review s are appearing . These have emerged in response to policymakers and other stakeholders ’ needs for information , sometimes emergently or urgently , for which the existing systematic review model does not quite fit . Hence , the rapid review , when time is of the essence ; the scoping review , when what is needed is not detailed answers to specific questions but rather an overview of a broad field ; the evidence map , a cousin of scoping review s that commonly has a specific visual presentation of the evidence across a broad field ; and the realist review , where the question of interest includes how and why complex social interventions work in certain situations , rather than assume they either do or do not work at all . As Editors , we regularly get contacted by prospect i ve authors asking whether realist review s , or scoping review s , etc . , are “ within the scope ” for Systematic Review s , and therefore we judge it an opportune time to state our position on this matter . It is our view that all of these new forms of review s are related to systematic review s , similar to the way that different biological Species within the same Family are related to each other . We consider “ systematic review s ” to be the Family and the different forms of review s to be the different species . Just as in the biological classification , where the related organisms must share certain characteristics , so too must the different types of review s share a common characteristic . In this case , what is shared is their foundation in the scientific method , with their methods articulated in advance in sufficient detail that the review can be reproduced by others . A further defining feature is that there are scholars devoted to improving the methods over time via hypothesis-testing studies . Systematic Review s has responded to these emerging techniques and already publishes papers reporting methods and findings from the systematic review family and has for example published an extremely popular series on rapid review s. We would like to consoli date this position and invite su bmi ssion of these new species of review s , as long as they meet the qualifications just listed . We expect this process of evolution to continue and to refine the methods such that in 10 years ’ time , there will appear new , as yet unimagined species of review s— and perhaps some current species of review will become extinct . Thus , it is with the scientific method , which we believe is the foundation that unites the Family of systematic review Introduction Quality assessment of included studies is an important component of systematic review s. Objective The authors investigated inter-rater and test – retest reliability for quality assessment s conducted by inexperienced student raters . Design Student raters received a training session on quality assessment using the Jadad Scale for r and omised controlled trials and the Newcastle – Ottawa Scale ( NOS ) for observational studies . Raters were r and omly assigned into five pairs and they each independently rated the quality of 13–20 articles . These articles were drawn from a pool of 78 papers examining cognitive impairment following electroconvulsive therapy to treat major depressive disorder . The articles were r and omly distributed to the raters . Two months later , each rater re-assessed the quality of half of their assigned articles . Setting McMaster Integrative Neuroscience Discovery and Study Program . Participants 10 students taking McMaster Integrative Neuroscience Discovery and Study Program courses . Main outcome measures The authors measured inter-rater reliability using κ and the intraclass correlation coefficient type 2,1 or ICC(2,1 ) . The authors measured test – retest reliability using ICC(2,1 ) . Results Inter-rater reliability varied by scale question . For the six-item Jadad Scale , question -specific κs ranged from 0.13 ( 95 % CI −0.11 to 0.37 ) to 0.56 ( 95 % CI 0.29 to 0.83 ) . The ranges were −0.14 ( 95 % CI −0.28 to 0.00 ) to 0.39 ( 95 % CI −0.02 to 0.81 ) for the NOS cohort and −0.20 ( 95 % CI −0.49 to 0.09 ) to 1.00 ( 95 % CI 1.00 to 1.00 ) for the NOS case – control . For overall scores on the six-item Jadad Scale , ICC(2,1)s for inter-rater and test – retest reliability ( accounting for systematic differences between raters ) were 0.32 ( 95 % CI 0.08 to 0.52 ) and 0.55 ( 95 % CI 0.41 to 0.67 ) , respectively . Corresponding ICC(2,1)s for the NOS cohort were −0.19 ( 95 % CI −0.67 to 0.35 ) and 0.62 ( 95 % CI 0.25 to 0.83 ) , and for the NOS case – control , the ICC(2,1)s were 0.46 ( 95 % CI −0.13 to 0.92 ) and 0.83 ( 95 % CI 0.48 to 0.95 ) . Conclusions Inter-rater reliability was generally poor to fair and test – retest reliability was fair to excellent . A pilot rating phase following rater training may be one way to improve agreement Objective To evaluate the reliability of risk of bias assessment s based on published trial reports , for determining trial inclusion in meta-analyses . Design Reliability evaluation of risk of bias assessment s. Data sources 13 published individual participant data ( IPD ) meta-analyses in cancer were used to source \n Output:\n " }, { "from": "agent", "value": "For quality appraisal , studies supported intensive training , piloting quality assessment tools , providing decision rules for poorly reported studies , contacting authors , and using structured tools if different study design s are included ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: AIMS To evaluate the efficacy and safety of orally administered naltrexone , alone or in combination with nicotine patches , as a treatment for cigarette smoking . DESIGN R and omized , partially-blinded , 2 x 2 factorial trial using naltrexone ( active vs. placebo ) and nicotine patches ( active vs. none ) . PARTICIPANTS One hundred cigarette smokers . INTERVENTION Twelve weeks of either placebo-only , naltrexone-only , placebo with nicotine patches or naltrexone with nicotine patches . The naltrexone dose was 50 mg taken once daily , and the nicotine patch dose was 21 mg/24-hour for the first 8 weeks and 14 mg/24-hour for the remaining 4 weeks . Brief behavioral intervention was provided at each visit . MEASUREMENTS One-week point-prevalence smoking abstinence rates confirmed by an expired air carbon monoxide level of 8 parts per million ( ppm ) or less , daily cigarette smoking and cigarette craving . FINDINGS At the end of treatment , there was no effect of naltrexone on smoking abstinence . The smoking abstinence rates were 19 % and 22 % for the placebo only and naltrexone only treatment groups , respectively , and 48 % and 46 % for the placebo with nicotine patch and naltrexone with nicotine patch groups , respectively . However , the effect of the nicotine patch at this time was significant ( p = 0.006 ) , but not at the 6-month follow-up . No significant effect of naltrexone was observed on daily cigarette smoking on cigarette craving during the study . CONCLUSIONS The opioid antagonist naltrexone was not found to be effective for smoking cessation and had no significant effect on daily cigarette consumption or craving . The results of the present study provide no support for the use of naltrexone , alone or in combination with nicotine patches , as a therapeutic treatment for smoking cessation A promising option in substance abuse treatment is the Community Reinforcement Approach ( CRA ) . The opioid antagonist naltrexone ( NTX ) may work in combination with nicotine replacement therapy ( NRT ) to block the effects of smoking stimuli in abstinent smokers . Effects of lower doses than 50 mg/dd . have not been reported . A study was conducted in Amsterdam in 2000/2001 with the objective to explore the effects of the combination NTX ( 25/50-mg dd . ) , NRT , and CRA in terms of craving and abstinence . In a r and omized open label , 2 × 2 between subjects design , 25 recovered spontaneous pneumothorax ( SP ) participants received 8 weeks of treatment . Due to side effects , only 3 participants were compliant in the 50-mg NTX condition . Craving significantly declined between each measurement and there was a significant interaction between decline in craving and craving measured at baseline . The abstinence rate in the CRA group was nearly double that in the non-psychosocial therapy group ( 46 % vs. 25 % ; NS ) at 3 months follow-up after treatment Rationale Human behavioral pharmacology studies can examine how medications that target different neurotransmitter systems influence different aspects of smoking . Naltrexone and bupropion have been shown to alter ad lib smoking behavior ; however , medication effects on nicotine reward in a cigarette choice paradigm have yet to be investigated . Objective This study explored the effects of an acute dose of naltrexone , bupropion , or placebo on the relative reinforcing value of nicotine from cigarette smoking using new nicotine and de-nicotinized ( Quest , 0.6 and 0.05 mg = “ denicotinized ” ) cigarettes . Methods In a double-blind , within-subjects design , 26 dependent smokers participated in three experimental cigarette smoking sessions following pretreatment with either naltrexone ( 50 mg ) , bupropion ( 300 mg ) , or placebo . After medication administration and 2 h of monitored deprivation from cigarettes and food , participants rated their responses to the initial exposure to the cigarettes and then participated in four choice sessions over a 2-h period during which they could take four puffs from either cigarette . Results The relative reinforcing value of nicotine , as measured by the number of nicotine puffs chosen out of 16 , was significantly lower following naltrexone compared to placebo . There were no effects of an acute dose of bupropion on nicotine choices . Conclusions These results suggest that naltrexone may reduce the relative reinforcing effects of nicotine via cigarette smoking and support ongoing investigation of opioid antagonists as potential smoking cessation pharmacotherapies E FOR AN association between nicotine and the endogenous opioid system comes from several lines of research . Studies have shown that administration of nicotine and /or stimulation of nicotinic receptors activates -endorphin and enkephalin release and bio synthesis ( Eiden et al. , 1984 ; Gilbert et al. , 1992 ; Houdi et al. , 1991 ; Pomerleau et al. , 1983 ) . In addition to having higher rates of smoking than in the general population , heroin addicts have been shown to smoke more during heroin selfinjection ( Mello et al. , 1980 ) and smoke less during methadone dose tapering ( Bigelow et al. , 1981 ) . Furthermore , opioid antagonists block certain effects of nicotine , including antinociception , operant responding , and prolactin release ( Aceto et al. , 1993 ; Corrigall et al. , 1988 ; Flores et al. , 1989 ) . The opioid antagonist naloxone has also been shown to induce withdrawal-like states in nicotine-dependent rats and humans ( Krishnan-Sarin et al. , 1999 ; Malin et al. , 1993 , 1996 ) . Conversely , nicotine has also been shown to suppress opioid antagonist effects such as decreasing naloxone-induced jumping in morphine-dependent mice ( Brase et al. , 1974 ; Zarrindast and Farzin , 1996 ) . Although there seems to be evidence of an opioid – nicotine interaction from in vivo and in vitro studies , human pre clinical studies have largely shown mixed results . Specifically , there are varied results from laboratory studies on the effects of the opioid antagonists naltrexone ( or intravenous naloxone ) on aspects of smoking response . Some studies have shown that naltrexone or naloxone significantly reduce subjects ’ self-reported pleasure or satisfaction from smoking ; perceived difficulty in abstaining , craving , and urge to smoke ; and the number of cigarettes smoked or puffs taken ( Gorelick et al. , 1989 ; Houtsmuller et al. , 1997 ; Karras and Kane , 1980 ; King and Meyer , 2000 ; Palmer and Berens , 1983 ; Sutherl and et al. , 1995 ; Wewers et al. , 1998 ) . In conjunction with the nicotine patch , naltrexone has also been shown to significantly decrease negative affect and craving after presentation of a smoking cue ( Hutchison et al. , 1999 ) . However , these findings are not ubiquitous , as other studies have failed to show significant effects of opioid antagonists on altering ad libitum smoking , number of cigarettes or puffs taken , or desire to smoke ( Gorelick et al. , 1989 ; Houtsmuller et al. , 1997 ; NemethCoslett and Griffiths , 1986 ; Sutherl and et al. , 1995 ) . Also , naltrexone or naloxone has been shown to increase smokers ’ negative mood and withdrawal-like symptoms ( Brauer et al. , 1999 ; Krishnan-Sarin et al. , 1999 ) . Collectively , there seems to be a lack of consistency in findings from pre clinical human laboratory studies on opioid antagonist effects on smoking behaviors . Although there are no simple explanations , several method ological issues may be contributing to this disparity , such as the use of small sample sizes , lack of statistical power , a range of naltrexone or naloxone doses or routes of administration , and fundamental differences in paradigms ( timing issues , degree of naturalism , baseline abstinence , etc . ) . A few studies have examined naltrexone in smoking cessation , and no studies have examined concurrent smoking and alcohol behaviors in study patients . As in laboratory studies , the results from clinical trials using adjunct treatment with naltrexone for nicotine dependence have shown mixed results , with negative findings in one study ( Wong et al. , 1999 ) and positive or mixed findings in two other studies ( Covey et al. , 1999 ; O’Malley et al. , 1997 ) . Although it is well established that alcohol may increase the risk for smoking relapse ( Baer and Lichtenstein , 1988 ; Br and on et al. , 1990 ; Shiffman 1982 , 1986 ) , smoking cessation trials have not systematic ally targeted pharmacological treatment strategies that may affect both behaviors . It is possible that naltrexone , a medication used for alcohol dependence ( O’Malley et al. , 1992 ; Volpicelli et al. , 1992 ) and posited to block alcohol ’s pleasurable effects ( King et al. , 1997 ; O’Malley et al. , 1996 ; Swift et al. , 1994 ; Volpicelli et al. , 1995 ) , might theoretically be an effective smoking cessation treatment agent , especially in smokers who drink . This may be due in part to direct nicotine – opioid system interactions ( as stated earlier ) , as well as blockade of alcohol reward and concomitant drinking episodes , which bode poorly for smoking outcome . Finally , the timing of naltrexone may be an important variable . Data from our previous laboratory study ( King and Meyer , 2000 ) indicate that naltrexone attenuated smoking urge and pleasure during and after cigarette exposure ; therefore , medication r and omization From the Department of Psychiatry , University of Chicago Pritzker School of Medicine , Chicago , Illinois . Received for publication August 2 , 2002 ; accepted September 5 , 2002 . Supported by NIH K08-AA00276 , P30 CA14599 - 28 , and M01-RR00055 . Reprint requests : Reprint requests : And rea King , PhD , University of Chicago , Department of Psychiatry , 5841 S. Maryl and Avenue , Chicago , IL 60637 ; Fax : 773 - 702 - 6454 ; E-mail : [email protected] Copyright © 2002 by the Research Society on Alcoholism Rationale : The role of endogenous opiate systems in cigarette smoking remains unclear . In laboratory animals , opiate antagonists block many of the effects of nicotine , but in humans they do not consistently alter smoking behavior . Objective : This study explored the effects of naltrexone , alone and in combination with nicotine , on smoking behavior . Methods : In a double-blind , double-dummy , within-subjects design , 19 regular smokers received four treatments of 1 week duration : naltrexone tablet ( 50 mg ) plus placebo skin patch , placebo tablet plus nicotine skin patch ( 21 mg/24 h ) , naltrexone tablet plus nicotine skin patch , and placebo tablet plus placebo skin patch . During each treatment , subjects rated their responses to nicotine-containing and denicotinized cigarettes in the laboratory , and to their own br and of cigarette smoked ad libitum outside the laboratory . Results : Pretreatment with the nicotine patch attenuated smoking-induced decreases in craving , negative affect , and rates of ad lib smoking , and potentiated the aversiveness of a cigarette . Naltrexone reversed these effects of the nicotine patch , and produced negative effects on mood . Conclusions : The blockade of nicotine ’s effects by naltrexone supports a role for opioid mechanisms in cigarette smoking This within-subjects , placebo-controlled laboratory study was design ed to examine the effects of naltrexone on cigarette response in 44 chronic smokers ( 23 male , 21 female ) . Each participant received either 50-mg oral naltrexone or identical placebo during the morning of the session after maintaining overnight abstinence . Subsequently , the participant was administered a smoking cue ( holding lit cigarette ) to examine craving and associated features of smoking , and instructed to smoke a cigarette 1 h later . This was followed by a smoking interval in which participants could choose to smoke up to four more cigarettes over a 2-h period . Subjective measures ( withdrawal , craving , affect , and side effects ) and smoking behavior were assessed throughout the session . Naltrexone significantly reduced the total number of choice cigarettes smoked and expired carbon monoxide levels ( Ps<.05 ) . Naltrexone significantly increased total side effects , especially for sedation ( P<.01 ) . Further , naltrexone significantly increased overall negative \n Output:\n " }, { "from": "agent", "value": "AUTHORS ' CONCLUSIONS Based on data from eight trials and over 1200 individuals , there was no evidence of an effect of naltrexone alone or as an adjunct to NRT on long-term smoking abstinence , with a point estimate strongly suggesting no effect and confidence intervals that make a clinical ly important effect of treatment unlikely ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Currently , no pharmacological treatments for bipolar depression exist that exert rapid ( within hours ) antidepressant or antisuicidal effects . We previously reported that intravenous administration of the N-methyl-D-aspartate antagonist ketamine produced rapid antidepressant effects in patients with treatment-resistant bipolar depression . The present study sought to replicate this finding in an independent sample . METHODS In this double-blind , r and omized , crossover , placebo-controlled study , 15 subjects with DSM-IV bipolar I or II depression maintained on therapeutic levels of lithium or valproate received a single intravenous infusion of either ketamine hydrochloride ( .5 mg/kg ) or placebo on 2 test days 2 weeks apart . The primary outcome measure was the Montgomery-Asberg Depression Rating Scale , which was used to rate overall depressive symptoms at baseline ; at 40 , 80 , 110 , and 230 minutes postinfusion ; and on days 1 , 2 , 3 , 7 , 10 , and 14 postinfusion . RESULTS Within 40 minutes , depressive symptoms , as well as suicidal ideation , significantly improved in subjects receiving ketamine compared with placebo ( d = .89 , 95 % confidence interval = .61 - 1.16 , and .98 , 95 % confidence interval = .64 - 1.33 , respectively ) ; this improvement remained significant through day 3 . Seventy-nine percent of subjects responded to ketamine and 0 % responded to placebo at some point during the trial . The most common side effect was dissociative symptoms , which occurred only at the 40-minute time point . CONCLUSIONS This study replicated our previous finding that patients with bipolar depression who received a single ketamine infusion experienced a rapid and robust antidepressant response . In addition , we found that ketamine rapidly improved suicidal ideation in these patients Several electrical neural oscillatory abnormalities have been associated with schizophrenia , although the underlying mechanisms of these oscillatory problems are unclear . Animal studies suggest that one of the key mechanisms of neural oscillations is through glutamatergic regulation ; therefore , neural oscillations may provide a valuable animal– clinical interface on study ing glutamatergic dysfunction in schizophrenia . To identify glutamatergic control of neural oscillation relevant to human subjects , we studied the effects of ketamine , an N-methyl-D-aspartate antagonist that can mimic some clinical aspects of schizophrenia , on auditory-evoked neural oscillations using a paired-click paradigm . This was a double-blind , placebo-controlled , crossover study of ketamine vs saline infusion on 10 healthy subjects . Clinical ly , infusion of ketamine in subanesthetic dose significantly increased thought disorder , withdrawal – retardation , and dissociative symptoms . Ketamine significantly augmented high-frequency oscillations ( gamma b and at 40–85 Hz , p=0.006 ) and reduced low-frequency oscillations ( delta b and at 1–5 Hz , p<0.001 ) compared with placebo . Importantly , the combined effect of increased gamma and reduced delta frequency oscillations was significantly associated with more withdrawal – retardation symptoms experienced during ketamine administration ( p=0.02 ) . Ketamine also reduced gating of the theta-alpha ( 5–12 Hz ) range oscillation , an effect that mimics previously described deficits in schizophrenia patients and their first-degree relatives . In conclusion , acute ketamine appeared to mimic some aspects of neural oscillatory deficits in schizophrenia , and showed an opposite effect on scalp-recorded gamma vs low-frequency oscillations . These electrical oscillatory indexes of subanesthetic ketamine can be potentially used to cross-examine glutamatergic pharmacological effects in translational animal and human studies We administered ketamine to schizophrenic individuals in a double-blind , placebo-controlled design using a range of subanesthetic doses ( 0.1 , 0.3 , and 0.5 mg/kg ) to evaluate the nature , dose characteristics , time course , and neuroleptic modulation of N-methyl-D-aspartate ( NMDA ) antagonist action on mental status in schizophrenia . Ketamine induced a dose-related , short ( < 30 minutes ) worsening in mental status in the haloperidol-treated condition , reflected by a significant increase in BPRS total score for the 0.3 mg/kg ( p = . 005 ) and 0.5 mg/kg ( p = . 01 ) challenges . Positive symptoms ( hallucinations , delusions , thought disorder ) , not negative symptoms accounted for these changes . These ketamine-induced psychotic symptoms were strikingly reminiscent of the subject 's symptoms during active episodes of their illness . Results from six patients who were retested in the same design after being neuroleptic-free for 4 weeks failed to indicate that haloperidol blocks ketamine-induced psychosis . Several subjects evidence d delayed or prolonged ( 8–24 hours ) psychotomimetic effects such as worsening of psychosis with visual hallucinations . These data suggest that antagonism of NMDA-sensitive glutamatergic transmission in brain exacerbates symptoms of schizophrenia OBJECTIVE To investigate the effects of ketamine on the electroencephalogram ( EEG ) of the horse . STUDY DESIGN Prospect i ve experimental study . ANIMALS Eight Welsh mountain pony geldings weighing between 280 and 330 kg , 5 to 9 years old . METHODS During halothane anesthesia at an end-tidal halothane concentration between 0.75 and 0.85 % , the EEG frequency power spectrum and the auditory evoked potential were recorded while an infusion of ketamine was given . Ketamine 200 mg was infused over 5 minutes in 8 ponies . The effects of ketamine on the EEG were recorded continuously during the infusion and for a further 55 minutes . RESULTS The ketamine infusion produced a plasma ketamine concentration that was significantly greater than the baseline until 7 minutes after the start of the infusion . The highest recorded ketamine concentration was 4.2+/-1.1 microg/ml recorded at 5 minutes after the start of the infusion . The spectral edge and median frequency of the EEG and the midlatency of the auditory evoked potential were compared with those recorded before the start of the infusion . The spectral edge , median frequencies and mid-latency of the auditory evoked potential were reduced by 21+/-13 % , 31+/-20 % and 19+/-36 % respectively ( mean + /- SD ) . Only the reduction in spectral edge frequency reached statistical significance . CONCLUSIONS These results compared with those from other anesthetic and sedative agents suggest that the spectral edge frequency is an indicator of general central nervous system depression whereas the median frequency may be an indicator of antinociception This r and omized , placebo-controlled , double-blind study was the first to evaluate the antidepressant efficacy , safety , and tolerability of an NR2B subunit-selective N-methyl-D-aspartate receptor antagonist , CP-101,606 . Subjects had major depression , according to Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition criteria and a history of treatment refractoriness to least 1 adequate trial of a selective serotonin reuptake inhibitor . The study had 2 treatment periods . In period 1 , subjects first received a 6-week open-label trial of paroxetine and a single-blind , intravenous placebo infusion . Period 1 nonresponders ( n = 30 ) then received a r and omized double-blind single infusion of CP-101,606 or placebo plus continued treatment with paroxetine for up to an additional 4 weeks ( period 2 ) . Depression severity was assessed using the Montgomery-Åsberg Depression Rating Scale and 17-item Hamilton Depression Rating Scale . On the prespecified main outcome measure ( change from baseline in the Montgomery-Åsberg Depression Rating Scale total score at day 5 of period 2 ) , CP-101,606 produced a greater decrease than did placebo ( mean difference , 8.6 ; 80 % confidence interval , −12.3 to −4.5 ) ( P < 0.10 ) . Hamilton Depression Rating Scale response rate was 60 % for CP-101,606 versus 20 % for placebo . Seventy-eight percent of CP-101,606-treated responders maintained response status for at least 1 week after the infusion . CP-101,606 was safe , generally well tolerated , and capable of producing an antidepressant response without also producing a dissociative reaction . Antagonism of the NR2B subtype of the N-methyl-D-aspartate receptor may be a fruitful target for the development of a new antidepressant with more robust effects and a faster onset compared with those currently available and capable of working when existing antidepressants do not Background : The potential adverse effects of ketamine in neurosurgical anesthesia have been well established and involve increased intracranial pressure ( ICP ) and cerebral blood flow . However , reexamination of ketamine is warranted because data regarding the effects of ketamine on cerebral hemodynamics are conflicting . Methods : Eight patients with traumatic brain injury were studied . In all patients , ICP monitoring was instituted before the study . Control of ICP ( less than 25 mmHg ) , hemodynamic values , and blood gas tension ( partial pressure of carbon dioxide in arterial blood between 35–38 mmHg ) was obtained with propofol infusion ( 3 mg [ center dot ] kg sup ‐1 [ center dot ] h sup ‐1 ) and mechanical ventilation . The effects of three doses of ketamine , 1.5 , 3 , and 5 mg/ kg , respectively , on ICP , cerebral perfusion pressure , jugular vein bulb oxygen saturation , middle cerebral artery blood flow velocity , and electric activity of the brain ( EEG ) were measured . The three doses were administered intravenously at 6‐h intervals over 30 s through a central venous line . Systemic and cerebral hemodynamics and end‐tidal carbon dioxide were continuously monitored and recorded at 1‐min intervals throughout the 30‐min study periods . Results : Ketamine , in all three doses studied ( 1.5 , 3 , and 5 mg/kg ) was associated with a significant decrease in ICP ( mean + /‐ SD : 2 + /‐ 0.5 mmHg [ P < 0.05 ] , 4 + /‐ 1 mmHg [ P < 0.05 ] , and 5 + /‐ 2 mmHg [ P < 0.05 ] ) among the study patients regardless of the ketamine dose used . There were no significant differences in cerebral perfusion pressure , jugular vein bulb oxygen saturation , and middle cerebral artery blood flow velocity . Ketamine induced a low‐amplitude fast‐activity electroencephalogram , with marked depression , such as burst suppression . Conclusions : These results suggest that ketamine may not adversely alter cerebral hemodynamics of mechanically ventilated head‐trauma patients se date d with propofol . These encouraging results should be confirmed in larger groups of similar patients The electroencephalographic ( EEG ) effects of ketamine anaesthesia have been a subject of earlier studies in man ' and in a n i r n a l ~ . ~ ~ ~ The present investigation was part of a larger study into the cardiovascular and electroencephalographic changes following the injection of various anaesthetics including A l t h e ~ i n . ~ . ~ Equivalent doses of ketamine were given twice at different rates of administration in two groups of patients and cerebral electrical activity was assessed . This was done both by conventional EEG recording and a single channel monitoring device ( cerebral function monitor or CFM),6 the use of which has already been described both in relation to anae ~ thesia,~ cerebral anoxia ' and cardiovascular surgery . ' The aim of this study was to determine the time of onset and the sequence of changes in the cerebral activity due to ketamine BACKGROUND To characterize further behavioral , cognitive , neuroendocrine , and physiological effects of subanesthetic doses of ketamine hydrochloride in healthy human subjects . Ketamine , a phencyclidine hydrochloride derivative , is a dissociative anesthetic and a noncompetitive antagonist of the N-methyl-D-aspartate subtype of excitatory amino acid receptor . METHODS Nineteen healthy subjects recruited by advertisements from the community participated in this r and omized , double-blind , placebo-controlled study . Subjects completed three test days involving the 40-minute intravenous administration of placebo , ketamine hydrochloride ( 0.1 mg/kg ) , or ketamine hydrochloride ( 0.5 mg/kg ) . Behaviors associated with the positive and negative symptoms of schizophrenia were assessed by using the Brief Psychiatric Rating Scale . Changes in perception and behaviors associated with dissociative states were assessed by the Perceptual Aberration Subscale of the Wisconsin Psychosis Proneness Scale and the Clinician-Administered Dissociative States Scale . Cognitive function was assessed by using the ( 1 ) Mini-Mental State Examination ; ( 2 ) tests sensitive to frontal cortical dysfunction , including \n Output:\n " }, { "from": "agent", "value": "We also discuss some of the current hypotheses that are considered to account for the actions of NMDAR antagonists on these frequency b and s. The data emphasize a close relationship between altered oscillatory activity and NMDAR blockade , with both local and large-scale networks accounting for their effects .\nThese findings may have fundamental implication s for the psychotomimetic effects produced by NMDAR antagonists" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Keeping abdominal surgery patients warm is common and warming methods are needed in power outages during natural disasters . We aim ed to evaluate the efficacy of low-cost , low-power warming methods for maintaining normothermia in abdominal surgery patients . Methods Patients ( n = 160 ) scheduled for elective abdominal surgery were included in this prospect i ve clinical study . Five warming methods were applied : heated blood transfusion/fluid infusion vs. unheated ; wrapping patients vs. not wrapping ; applying moist dressings , heated or not ; surgical field rinse heated or not ; and applying heating blankets or not . Patients ’ nasopharyngeal and rectal temperatures were recorded to evaluate warming efficacy . Significant differences were found in mean temperatures of warmed patients compared to those not warmed . Results When we compared temperatures of abdominal surgery patient groups receiving three specific warming methods with temperatures of control groups not receiving these methods , significant differences were revealed in temperatures maintained during the surgeries between the warmed groups and controls . Discussion The value of maintaining normothermia in patients undergoing abdominal surgery under general anesthesia is accepted . Three effective economical and practically applicable warming methods are combined body wrapping and heating blanket ; combined body wrapping , heated moist dressings , and heating blanket ; combined body wrapping , heated moist dressings , and warmed surgical rinse fluid , with or without heating blanket . These methods are practically applicable when low-cost method is indeed needed BACKGROUND Mild perioperative hypothermia , which is common during major surgery , may promote surgical-wound infection by triggering thermoregulatory vasoconstriction , which decreases subcutaneous oxygen tension . Reduced levels of oxygen in tissue impair oxidative killing by neutrophils and decrease the strength of the healing wound by reducing the deposition of collagen . Hypothermia also directly impairs immune function . We tested the hypothesis that hypothermia both increases susceptibility to surgical-wound infection and lengthens hospitalization . METHODS Two hundred patients undergoing colorectal surgery were r and omly assigned to routine intraoperative thermal care ( the hypothermia group ) or additional warming ( the normothermia group ) . The patient 's anesthetic care was st and ardized , and they were all given cefam and ole and metronidazole . In a double-blind protocol , their wounds were evaluated daily until discharge from the hospital and in the clinic after two weeks ; wounds containing culture-positive pus were considered infected . The patients ' surgeons remained unaware of the patients ' group assignments . RESULTS The mean ( + /- SD ) final intraoperative core temperature was 34.7 + /- 0.6 degrees C in the hypothermia group and 36.6 + /- 0.5 degrees C in the normothermia group ( P < 0.001 ) Surgical-wound infections were found in 18 of 96 patients assigned to hypothermia ( 19 percent ) but in only 6 of 104 patients assigned to normothermia ( 6 percent , P = 0.009 ) . The sutures were removed one day later in the patients assigned to hypothermia than in those assigned to normothermia ( P = 0.002 ) , and the duration of hospitalization was prolonged by 2.6 days ( approximately 20 percent ) in hypothermia group ( P = 0.01 ) . CONCLUSIONS Hypothermia itself may delay healing and predispose patients to wound infections . Maintaining normothermia intraoperatively is likely to decrease the incidence of infectious complications in patients undergoing colorectal resection and to shorten their hospitalizations In this prospect i ve trial a study was made of the effect of warm irrigation on blood loss during transurethral prostatectomy ( TURP ) . A control group of 21 patients in whom irrigating fluid at operating room temperature ( mean 21.5 degrees C ) had been used was compared with a statistically comparable group of 19 patients in whom warm irrigating fluid ( mean 33.1 degrees C ) had been used . Blood loss in ml , in ml/g of tissue resected and in ml/min of resection time was not increased by the use of warm rather than room temperature irrigation . It was found that warm irrigation decreased heat loss and shivering in the patient during TURP and led to improved comfort both for patient and operator . The method of heating the irrigation bags was safe and economical Changes in mean body temperature and muscle protein metabolism were studied in elderly patients undergoing large bowel surgery . Two groups were studied : in one , efforts were made to maintain the patients normothermic during and after surgery by warming the fresh gases , the i.v . fluids , by placing warmed cotton padding around the exposed parts of the body and by covering the patients with a metallized plastic sheet in the recovery period . The other group received routine management . Otherwise the anaesthetic technique was comparable . The excretion of the amino acid 3-methylhistidine ( 3-MeH ) , an indicator of muscle protein breakdown , and urea nitrogen loss were measured in the urine collected the day before , and on the 2nd and 4th postoperative days . Prevention of heat loss during and after surgery caused a significant decrease in muscle protein degradation and nitrogen loss OBJECTIVE to verify the effectiveness of warmed intravenous infusion for hypothermia prevention in patients during the intraoperative period . METHOD experimental , comparative , field , prospect i ve and quantitative study undertaken at a federal public hospital . The sample was composed of 60 adults , included based on the criteria of axillary temperature between 36ºC and 37.1ºC and surgical abdominal access , divided into control and experimental groups , using the systematic probability sampling technique . RESULTS 22 patients ( 73.4 % ) from both groups left the operating room with hypothermia , that is , with temperatures below 36ºC ( p=1.0000 ) . The operating room temperature when patients arrived and patients ' temperature when they arrived at the operating room were statistically significant to affect the occurrence of hypothermia . CONCLUSION the planning and implementation of nursing interventions carried out by baccalaureate nurses are essential for preventing hypothermia and maintaining perioperative normothermia Mild intraoperative hypothermia is common . We therefore studied the effects of mild hypothermia on propofol pharmacokinetics , hepatic blood flow , and atracurium duration of action in healthy volunteers . Six young volunteers were studied on two r and omly assigned days , at either 34 degrees C or 37 degrees C. Anesthesia was induced with thiopental , 3 mg/kg , and maintained with 70 % N2 O and 0.6 % isoflurane . Core hypothermia was induced by conductive and convective cooling . On the other study day , normothermia was maintained by a Bair Hugger Registered Trademark ( Augustine Medical , Inc. , Eden Prairie , MN ) forced-air warmer . Propofol , 1 mg/kg lean body mass ( LBM ) , then was given , followed by a 4-h infusion at 5 mg centered dot kg-1 centered dot h-1 . After 2 h , atracurium 0.5 mg/kg was administered as an intravenous bolus . Indocyanine green was administered for estimation of hepatic blood flow . Arterial blood was assayed for propofol and indocyanine green concentration . Pharmacokinetic analysis was performed using NONMEM . Results are reported as means + /- SEM . Propofol blood concentrations averaged approximate equals 28 % more at 34 degrees C than at 37 degrees C ( P < 0.05 ) . Hepatic blood flow decreased 23 % + /- 11 % in normothermic volunteers during the propofol infusion , and 33 % + /- 11 % in hypothermic volunteers ( P = not significant ) . A three-compartment mamillary model fitted the data best . Inclusion of hepatic blood flow change from the prepropofol baseline as a covariate for total body clearance significantly improved the fit . The intercompartmental clearances were decreased in the presence of hypothermia . Core hypothermia prolonged the time to recovery of the first twitch in the train-of-four to 10 % of its control value ( T1 = 10 % ) after atracurium administration by approximate equals 60 % ( P < 0.05 ) , from 44 + /- 4 min to 68 + /- 7 min . In contrast , T1 = 25%-75 % remained unchanged . We conclude that 3 degrees C of core hypothermia increased propofol blood concentrations and prolonged atracurium duration of action . Hepatic blood flow was decreased during propofol administration , and this change was a significant predictor of propofol clearance , indicating that the effect of propofol on hepatic blood flow impairs the clearance of propofol itself . ( Anesth Analg 1995;80:1007 - 14 Twenty-four unpremedicated patients of ASA class II or III undergoing TURP were given esia with 10 mg of tetracaine at level L3 - 4 or L4 - 5 . These patients were r and omly given \" warm \" or \" ambient temperature \" irrigating fluids . Those with irrigating fluids of temperature between 25.5 degrees C and 33 degrees C were arranged as Group 1 and those of temperature between 21.5 and 23 degrees C as Group 2 . The results failed to show that the incidence of shivering could be decreased by the use of warm irrigating fluids Background Postoperative hypothermia and shivering is a frequent event in patients during cesarean section under spinal anesthesia . We assessed the effect of preoperative warming during cesarean delivery under spinal anesthesia for prevention of hypothermia and shivering . Methods Forty five patients undergoing elective cesarean section were r and omly assigned to three groups . Group F received warmed intravenous fluid ( 40 ℃ ) . Group A patients were actively warmed by forced air-warming . Group C was the control group . Forced air-warming and warmed fluid was maintained for the 15 min preceding spinal anesthesia . Core temperature ( tympanic membrane ) and the skin temperature of arm and thigh were measured and shivering was grade d simultaneously . Results The core temperature at 45 min decreased less in Groups F and A than Group C ( -0.5 ℃ ± 0.3 ℃ vs -0.6 ℃ ± 0.4 ℃ vs -0.9 ℃ ± 0.4 ℃ , respectively ; P = 0.004 ) . The arm temperature at 15 min and 30 min exhibited a greater increase in Group A than Group F and Group C ( P = 0.001 and P = 0.012 , respectively ) . Leg temperature increased similarly among the three groups . The incidence of shivering was significantly less in Group A and Group F than Group C ( 20 % , 13.3 % , and 53.3 % , respectively ; P = 0.035 ) . Conclusions Preoperative forced air-warming and warmed fluid prevents hypothermia and shivering in patients undergoing elective cesarean delivery with spinal anesthesia OBJECTIVES To investigate the effect using irrigation fluid at body temperature ( isothermic ) on patients ' ( core ) temperature during a transurethral resection of the prostate ( TURP ) and on the amount of peri-operative blood loss , the resection time and the subjective assessment of comfort by the patients . PATIENT AND METHODS In a r and omized study , patients undergoing TURP under spinal anaesthesia were divided into those receiving either isothermic irrigation fluid ( Group 1.28 patients ) or fluid at room temperature ( Group 2.31 patients ) . In Group 1 , a fluid heater maintained the irrigation fluid at body temperature until it reached the bladder . The body temperature of the patients was recorded rectally and orally during and after TURP and the peri-operative blood loss was also measured . The patients were interviewed on the first day after TURP to determine their assessment of comfort during the procedure . RESULTS The decrease in body temperature was 0.74 degree C in Group 1 and 1.71 degrees C in Group 2 , which was significantly different ( P < 0.001 ) . There was no significant difference in blood loss or resection-time . In Group 1 , only four ( 14 % ) of the patients were aware that their body was cooler , compared to 15 ( 50 % ) in Group 2 ( P = 0.038 ) . CONCLUSION Isothermic irrigation during TURP prevents excessive cooling and reduces the level of hypothermia . The reported increased mortality after TURP is probably related to peri-operative cardiac stress , an important factor which could be caused by the rapid decrease in body temperature which accompanies normal irrigation . Because the heating equipment presently available does not interfere with TURP , there are strong arguments for performing every TURP with irrigation fluid at body temperature Purpose To determine the relative efficacy of heat conservation and convective warming in maintaining penoperative normothermia . ( central temperature ≥36 ° C ) . Methods Thirty-seven patients undergoing elective gynaecological , orthopaedic , or general surgery scheduled to last two hours were prospect jvely studied . Patients were r and omized to one of two groups . Group I patients received heat conservation with reflective blankets ( Thermadrape ™ , Vital Signs , Inc. , Totowa , NJ ) applied preoperatively and warmed iv fluids ( Hotline ™ SIMS Level I Technologies , Inc , Rockl and , MA ) . Group 2 patients received convective warming ( BairHugger , Augustine Medical , Inc. , Eden Prairie , MN ) after induction of anaesthesia and iv flu \n Output:\n " }, { "from": "agent", "value": "Evidence was unclear regarding the effects of fluid warming on bleeding .\nWarmed intravenous fluids also further reduced the risk of shivering compared with room temperature intravenous fluidsInvestigators reported no statistically significant differences in core body temperature or shivering between individuals given warmed and room temperature irrigation fluids .\nAUTHORS ' CONCLUSIONS Warm intravenous fluids appear to keep patients warmer during surgery than room temperature fluids .\nIt is unclear whether the actual differences in temperature are clinical ly meaningful , or if other benefits or harms are associated with the use of warmed fluids .\nIt is also unclear if using fluid warming in addition to other warming methods confers any benefit , as a ceiling effect is likely when multiple methods of warming are used" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Behavioral conditioned immunosuppression has been described in rodents as the most impressive demonstration of brain-to-immune system interaction . To analyze whether behavioral conditioned immunosuppression is possible in humans , healthy subjects in this double-blind , placebo-controlled study were conditioned in four sessions over 3 consecutive days , receiving the immunosuppressive drug cyclosporin A as an unconditioned stimulus paired with a distinctively flavored drink ( conditioned stimulus ) each 12 h. In the next week , re-exposure to the conditioned stimulus ( drink ) , but now paired with placebo capsules , induced a suppression of immune functions as analyzed by the IL-2 and IFN-gamma mRNA expression , intracellular production , and in vitro release of IL-2 and IFN-gamma , as well as lymphocyte proliferation . These data demonstrate for the first time that immunosuppression can be behaviorally conditioned in humans BACKGROUND This study aims to determine the role of patient expectations as potentially modifiable factor of side-effects , quality of life , and adherence to endocrine treatment of breast cancer . PATIENTS AND METHODS A 2-year prospect i ve clinical cohort study was conducted in routine primary care with postoperative patients with hormone-receptor-positive breast cancer , scheduled to start adjuvant endocrine treatment . Structured patient-reported assessment s of side-effects , side-effect expectations , quality of life , and adherence took place during the first week post-surgery and after 3 and 24 months of endocrine treatment . RESULTS Of 111 enrolled patients , at 3 and 24 months , 107 and 88 patients , respectively , were assessed . After 2 years of endocrine treatment , patients reported high rates of side-effects ( arthralgia : 71.3 % , weight gain : 53.4 % , hot flashes : 46.5 % ) , including symptoms not directly attributable to the medication ( breathing problems : 28.1 % , dizziness : 25.6 % ) . Pre-treatment expectations significantly predicted patient-reported long-term side-effects and quality of life in multivariate models controlling for relevant medical and psychological variables . Relative risk of side-effects after 2 years of endocrine treatment was higher in patients with high negative expectations at baseline than in those with low negative expectations ( RR = 1.833 , CI 95 % , 1.032 - 3.256 ) . A significant interaction confirmed this expectation effect to be particularly evident in patients with high side-effects at 3 months . Furthermore , baseline expectations were associated with adherence at 24 months ( r = -0.25 , P = 0.006 ) . CONCLUSIONS Expectations are a genuine factor of clinical outcome from endocrine treatment for breast cancer . Negative expectations increase the risk of treatment-specific side-effects , nocebo side-effects , and non-adherence . Yet , controlled studies are needed to analyze potential causal relationships . Optimizing individual expectations might be a promising strategy to improve side-effect burden , quality of life , and adherence during longer-term drug intake . TRIAL REGISTRATION Clinical Trials.gov Identifier : NCT02088710 OBJECTIVE To further develop and trial a brief in-hospital illness perception intervention for myocardial infa rct ion ( MI ) patients . METHODS One hundred and three patients admitted with acute MI were r and omized to receive either st and ard care or st and ard care plus an illness perception intervention , which consisted of three half-hour patient sessions and one half-hour patient- and -spouse session delivered in hospital . Patients were followed up to 6 months . The main outcome was the difference between groups in rate of return to work . RESULTS The intervention group had a faster rate of return to work than the control group , and more patients in the intervention group had returned to full time work by 3 months than in the control group . At discharge , patients in the intervention group demonstrated changes in causal attributions regarding their MI and higher perceived underst and ing of their condition , which remained at the 6-month follow-up . They also reported a better underst and ing of the information given in hospital , higher intentions to attend cardiac rehabilitation classes , lower anxiety about returning to work , greater increases in exercise , and made fewer phone calls to their general practitioner about their heart condition at follow-up . CONCLUSION This study replicates the findings of an earlier trial that a brief in-hospital illness perception intervention can change perceptions and improve rates of return to work in MI patients . It increases the generalizability of the intervention to the current broader definition of MI and to patients who have had previous infa rcts The placebo and nocebo effect is believed to be mediated by both cognitive and conditioning mechanisms , although little is known about their role in different circumstances . In this study , we first analyzed the effects of opposing verbal suggestions on experimental ischemic arm pain in healthy volunteers and on motor performance in Parkinsonian patients and found that verbally induced expectations of analgesia/hyperalgesia and motor improvement/worsening antagonized completely the effects of a conditioning procedure . We also measured the effects of opposing verbal suggestions on hormonal secretion and found that verbally induced expectations of increase/decrease of growth hormone ( GH ) and cortisol did not have any effect on the secretion of these hormones . However , if a preconditioning was performed with sumatriptan , a 5-HT1B/1D agonist that stimulates GH and inhibits cortisol secretion , a significant increase of GH and decrease of cortisol plasma concentrations were found after placebo administration , although opposite verbal suggestions were given . These findings indicate that verbally induced expectations have no effect on hormonal secretion , whereas they affect pain and motor performance . This suggests that placebo responses are mediated by conditioning when unconscious physiological functions such as hormonal secretion are involved , whereas they are mediated by expectation when conscious physiological processes such as pain and motor performance come into play , even though a conditioning procedure is performed We examined whether personality traits are differently associated with coronary heart disease and stroke mortality . Participants were pooled from three prospect i ve cohort studies ( Health and Retirement Study , Wisconsin Longitudinal Study graduate and sibling sample s ; n = 24,543 men and women , mean age 61.4 years , mortality follow-up between 3 and 15 years ) . There were 423 coronary heart disease deaths and 88 stroke deaths during 212,542 person-years at risk . Higher extraversion was associated with an increased risk of stroke ( hazard ratio per each st and ard deviation increase in personality trait HR = 1.41 , 95 % CI 1.10–1.80 ) but not with coronary heart disease mortality ( HR = 0.93 , 0.83–1.05 ) . High neuroticism , in turn , was more strongly related to the risk of coronary heart disease ( HR = 1.16 , 1.04–1.29 ) than stroke deaths ( HR = 0.95 , 0.78–1.17 ) . High conscientiousness was associated with lower mortality risk from both coronary heart disease ( HR = 0.74 , 0.67–0.81 ) and stroke ( HR = 0.78 , 0.63–0.97 ) . Cardiovascular risk associated with personality traits appears to vary between main cardiac and cerebral disease endpoints Background Illness perceptions have been shown to predict patient activities . Therefore , studies of the effectiveness of a targeted illness-perception intervention on chronic nonspecific low back pain ( CLBP ) are needed . Objective The purpose of this study was to compare the effectiveness of treatment of illness perceptions against a waiting list for patients with CLBP . Design This was a prospect ively registered r and omized controlled trial with an assessor blinded for group allocation . Setting The study was conducted in an outpatient rehabilitation clinic . Participants The participants were 156 patients ( 18–70 years of age ) with CLBP ( > 3 months ) . Intervention Patients were r and omly assigned to either a treatment group or to a waiting list ( control ) group . Trained physical therapists and occupational therapists delivered 10 to 14 one-hour treatment sessions according to the treatment protocol . Measurements The primary outcome measure was change in patient-relevant physical activities ( Patient-Specific Complaints question naire ) . The secondary outcome measures were changes in illness perceptions ( Illness Perceptions Question naire ) and generic physical activity level ( Quebec Back Pain Disability Scale ) . Measurements were taken at baseline ( 0 weeks ) and after treatment ( 18 weeks ) . Results A baseline-adjusted analysis of covariance showed that there were statistically significant differences between intervention and control groups at 18 weeks for the change in patient-relevant physical activities . This was a clinical ly relevant change ( 19.1 mm ) for the intervention group . Statistically significant differences were found for the majority of illness perception scales . There were no significant differences in generic physical activity levels . Limitations Longer-term effectiveness was not studied . Conclusions This first trial evaluating cognitive treatment of illness perceptions concerning CLBP showed statistically significant and clinical ly relevant improvements in patient-relevant physical activities at 18 weeks Background : Myocardial infa rct ion ( MI ) is one of the major causes of death and disability worldwide , which can reduces quality of life in patients . Some disabilities are depression and anxiety which delay returning to work . The aim of this study was to evaluate the effect of illness perception focused intervention on quality of life , anxiety , and depression in MI patients . Material s and Methods : A r and omized controlled trial study of 48 recently hospitalized MI patients was conducted ( 24 in intervention group and 24 in control group ) . Intervention group was trained to underst and the disease by a mental health counselor in three half-an-hour sessions for three consecutive days . Data were collected from three question naires : hospital anxiety and depression scale , the World Health Organization Quality of Life Question naire ( short form ) , and Illness Perceptions Question naire Brief at admission , 1.5 , and 3 months postdischarge . Data were analyzed with ANOVA repeated measure . Results : The mean duration of returning to work was 28.7 ± 8.1 days in intervention groups and 46 ± 7.6 days in control group which was statistically significant ( P < 0.001 ) . Moreover , anxiety , depression , and illness perceptions score were significantly decreased in intervention groups which were 8.3 ± 3.3 , 6.8 ± 3.5 , and 36.5 ± 5 in intervention groups and 15.8 ± 2.1(P < 0.001 ) , 17.1 ± 2.3 ( P < 0.001 ) , and 41.9 ± 4 ( P < 0.001 ) in control group , respectively . Mean of quality of life subscales scores just physical health subscale showed a significant reduction after 3 months in the control group . Conclusion : Training MI patients to underst and the disease in three half-an-hour sessions for 3 consecutive days can decrease the duration of returning to work , anxiety and depression , and increase illness perceptions which can make a better outcome Objective This study was design ed to examine whether a brief hospital intervention design ed to alter patients ’ perceptions about their myocardial infa rct ion ( MI ) would result in a better recovery and reduced disability . Design In a prospect i ve r and omized study , 65 consecutive patients with their first MI aged were assigned to receive an intervention design ed to alter their perceptions about their MI or usual care from rehabilitation nurses . Patients were assessed in hospital before and after the intervention and at 3 months after discharge from hospital . Results The intervention caused significant positive changes in patients ’ views of their MI . Patients in the intervention group also reported they were better prepared for leaving hospital ( p < .05 ) and subsequently returned to work at a significantly faster rate than the control group ( p < .05 ) . At the 3-month follow-up , patients in the intervention group reported a significantly lower rate of angina symptoms than control subjects ( 14.3 vs. 39.3 , p < .03 ) . There was no significant differences in rehabilitation attendance between the two groups . Conclusions An in-hospital intervention design ed to change patients ’ illness perceptions can result in improved functional outcome after MI Background Placebo effects contribute substantially to outcome in most fields of medicine . While clinical trials typically try to control or minimize these effects , the potential of placebo mechanisms to improve outcome is rarely used . Patient expectations about treatment efficacy and outcome are major mechanisms that contribute to these placebo effects . We aim ed to optimize these expectations to improve outcome in patients undergoing coronary artery bypass graft ( CABG ) surgery . Methods In a prospect i ve three-arm r and omized clinical trial with a 6 month follow-up , 124 patients scheduled for CABG surgery were r and omized to either a brief psychological pre-surgery intervention to optimize outcome expectations ( EXPECT ) ; or a psychological control intervention focusing on emotional support and general advice , but not on expectations ( SUPPORT ) ; or to st and ard medical care ( SMC ) . Interventions were kept brief to be feasible with a heart surgery environment ; “ dose ” of therapy was identical for both pre-surgery interventions . Primary outcome was disability 6 months after surgery . Secondary outcomes comprised further clinical and immunological variables . Results Patients in the EXPECT group showed significantly larger improvements in disability ( −12.6 ; −17.6 to −7.5 ) than the SMC group ( −1.9 ; −6.6 to + 2.7 ) ; patients in the SUPPORT group ( −6.7 ; −11.8 to 1.7 ) did not differ from the SMC group . Comparing follow-up scores and controlling for baseline scores of EXPECT versus SUP \n Output:\n " }, { "from": "agent", "value": "Expectation optimization approaches yielded particularly promising results .\nConclusion This review highlights the potential of EFPI for optimizing treatment of patients with medical conditions ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Telemedicine is widely considered as an efficient approach to manage the growing problem of chronic wounds . However , to date , there is no convincing evidence to support the clinical efficacy of telemedicine in wound management . In this prospect i ve cluster controlled study , we tested the hypothesis that advice on wound management provided by a team of wound-care specialists through telemedicine would significantly improve the likelihood of wound healing compared with the best available conventional practice . A total of 90 chronic wound patients in home care met all study criteria and were included : 50 in the telemedicine group and 40 in the conventional group . Patients with pressure ulcers , surgical wounds , and cancer wounds were excluded . During the 1-year follow-up , complete wound healing was achieved in 35 patients ( 70 % ) in the telemedicine group compared with 18 patients ( 45 % ) in the conventional group . After adjusting for important covariates , offering advice on wound management through telemedicine was associated with significantly increased healing compared with the best available conventional practice ( telemedicine vs. conventional practice : adjusted hazard ratio 2.19 ; 95 % confidence interval : 1.15 - 4.17 ; P=0.017 ) . This study strongly supports the use of telemedicine to connect home-care nurses to a team of wound experts in order to improve the management of chronic wounds HIV-positive adolescents and young adults often experience suboptimal medication adherence , yet few interventions to improve adherence in this group have shown evidence of efficacy . We conducted a r and omized trial of a two-way , personalized daily text messaging intervention to improve adherence to antiretroviral therapy ( ART ) among N = 105 poorly adherent HIV-positive adolescents and young adults , ages 16–29 . Adherence to ART was assessed via self-reported visual analogue scale ( VAS ; 0–100 % ) at 3 and 6-months for mean adherence level and proportion ≥90 % adherent . The average effect estimate over the 6-month intervention period was significant for ≥90 % adherence ( OR = 2.12 , 95 % CI 1.01–4.45 , p < .05 ) and maintained at 12-months ( 6 months post-intervention ) . Satisfaction scores for the intervention were very high . These results suggest both feasibility and initial efficacy of this approach . Given study limitations , additional testing of this intervention as part of a larger clinical trial with objective and /or clinical outcome measures of adherence is warranted BACKGROUND Cognitive-behavioural therapy (CBT)-based guided self-help is recommended as a first step in the treatment of bulimia nervosa . AIMS To evaluate in a r and omised controlled trial ( Clinical trials.gov registration number : NCT00461071 ) the long-term effectiveness of internet-based guided self-help ( INT-GSH ) compared with conventional guided bibliotherapy ( BIB-GSH ) in females with bulimia nervosa . METHOD A total of 155 participants were r and omly assigned to INT-GSH or BIB-GSH for 7 months . Outcomes were assessed at baseline , month 4 , month 7 and month 18 . RESULTS The greatest improvement was reported after 4 months with a continued reduction in eating disorder symptomatology reported at month 7 and 18 . After 18 months , 14.6 % ( n = 7/48 ) of the participants in the INT-GSH group and 25 % ( n = 7/28 ) in the BIB-GSH group were abstinent from binge eating and compensatory measures , 43.8 % ( n = 21/48 ) and 39.2 % ( n = 11/28 ) respectively were in remission . No differences regarding outcome between the two groups were found . CONCLUSIONS Internet-based guided self-help for bulimia nervosa was not superior compared with bibliotherapy , the gold st and ard of self-help . Improvements remain stable in the long term Background — Despite effective treatments to reduce cardiovascular disease risk , their translation into practice is limited . Methods and Results — Using a parallel arm cluster-r and omized controlled trial in 60 Australian primary healthcare centers , we tested whether a multifaceted quality improvement intervention comprising computerized decision support , audit/feedback tools , and staff training improved ( 1 ) guideline -indicated risk factor measurements and ( 2 ) guideline -indicated medications for those at high cardiovascular disease risk . Centers had to use a compatible software system , and eligible patients were regular attendees ( Aboriginal and Torres Strait Isl and er people aged ≥35 years and others aged ≥45 years ) . Patient-level analyses were conducted using generalized estimating equations to account for clustering . Median follow-up for 38 725 patients ( mean age , 61.0 years ; 42 % men ) was 17.5 months . Mean monthly staff support was < 1 hour/site . For the co primary outcomes , the intervention was associated with improved overall risk factor measurements ( 62.8 % versus 53.4 % risk ratio ; 1.25 ; 95 % confidence interval , 1.04–1.50 ; P=0.02 ) , but there was no significant differences in recommended prescriptions for the high-risk cohort ( n=10 308 ; 56.8 % versus 51.2 % ; P=0.12 ) . There were significant treatment escalations ( new prescriptions or increased numbers of medicines ) for antiplatelet ( 4.3 % versus 2.7 % ; P=0.01 ) , and BP lowering ( 18.2 % versus 11.0 % ; P=0.02 ) but not lipid-lowering medications . Conclusions — In Australian primary healthcare setting s , a computer-guided quality improvement intervention , requiring minimal support , improved cardiovascular disease risk measurement but did not increase prescription rates in the high-risk group . Computerized quality improvement tools offer an important , albeit partial , solution to improving primary healthcare system capacity for cardiovascular disease risk management . Clinical Trial Registration — URL : https://www.anzctr.org.au/Trial/ Registration /Trial Review .aspx?id=336630 . Australian New Zeal and Clinical Trials Registry No. 12611000478910 Adults with type 2 diabetes mellitus often struggle with their antihyperglycemic medication regimens . To improve medication management , providers must ensure that their patients underst and potential benefits , harms , and burdens of available options and elicit patients ' preferences and barriers to taking medications . Patients who are actively involved in treatment decision making tend to be more satisfied with their health care , be more adherent to treatment , and have improved clinical outcomes ( 13 ) . Such discussion s , however , can be too time-consuming for clinic visits . For inner-city low-income African American and Latino adults , low health literacy and limited English proficiency are often additional barriers ( 4 ) that reduce the exchange of information and decrease patient participation during primary care visits ( 58 ) . This contributes to less optimal treatment decisions and lower patient satisfaction , leading to poor medication adherence and outcomes ( 3 , 911 ) . There is therefore an urgent need for cost-effective approaches to enable low-re source health systems to help these high-risk population s gain information and decision support so that they can more actively participate in and improve satisfaction with their treatment decision making . Since 2000 , the REACH ( Racial and Ethnic Approaches to Community Health 2010 ) Detroit Partnership , a coalition of community , health system , and academic partners , has used community-based participatory research principles to guide development , implementation , and evaluation of interventions to meet this need among African American and Latino adults with diabetes in Detroit , Michigan . These interventions have built on evidence that community health workers ( CHWs ) are effective in improving diabetes outcomes , particularly among racial and ethnic minority communities ( 12 ) . CHW interventions train community members to work as bridges between their ethnic , cultural , or geographic communities and health care providers ( 13 ) . Two cohorts of participants in our previous CHW-led diabetes self-management support interventions improved hemoglobin A1c ( HbA1c ) levels and diabetes distress compared with usual care ( 14 , 15 ) . An important next step in increasing the potential effect of CHWs and other lay health care workers is to develop and test effective tools they can use to better present evidence -based information to patients and to help patients make better self-management decisions ( 16 ) . Little is known about the effectiveness of different approaches for nontraditional care providers , such as CHWs , to deliver health information to ethnic minority and low-literacy population s ( 17 ) . By definition , CHWs and other lay workers do not have medical expertise and thus rely on effectively sharing printed educational and support material s with patients as part of their coaching and counseling efforts . Decision aids can increase satisfaction with treatment decisions and result in treatments that better reflect patients ' preferences ( 18 , 19 ) . There is also evidence that tailored health messages are more effective than generic group messages ( 20 , 21 ) , including for patients with diabetes ( 22 , 23 ) . Tailoring individualizes information and behavior change strategies to reach each person based on characteristics unique to that person derived from an individual assessment and related to the outcome of interest ( 24 ) . Software programs that are being developed to automatically embed tailored content into portable e-health Web applications show promise in improving health behaviors and outcomes ( 25 , 26 ) . To date , however , most e-health applications have been design ed for use by patients with relatively high literacy and the skills to navigate them ( 27 ) . Do more sophisticated , tailored , interactive e-health tools increase the effectiveness of CHW outreach with underserved patients compared with reliance on printed educational material s alone ? We addressed this question by developing and evaluating a personally tailored , interactive diabetes medication decision aid ( iDecide [ in English ] or iDecido [ in Spanish ] ) design ed for CHWs to deliver on tablet computers with 3 G wireless access to African American and Latino adults with diabetes and low health literacy . We then evaluated the effectiveness of iDecide in improving key diabetes outcomes compared with CHW delivery of the same evidence -based information , without tailoring , through print consumer booklets developed by the Agency for Healthcare Research and Quality ( AHRQ ) . Methods Setting This study was developed and implemented by using community-based participatory research principles ( 28 ) in partnership with the REACH Detroit Partnership and the Community Health and Social Services Center ( CHASS ) , a federally qualified health center in Southwest Detroit serving more than 13000 patients with 47099 visits in 2012 ( 29 ) . The University of Michigan and CHASS institutional review boards approved the study . Content of AHRQ Consumer Guides The AHRQ guides ( Pills for Type 2 Diabetes and Premixed Insulin for Type 2 Diabetes ) ( 30 , 31 ) provide information on diabetes and summarize the effectiveness of currently available medication classes ( oral and insulin ) on HbA1c . They also provide information on administration methods , costs , medication adverse effects , risks for diabetes complications , suggested questions to discuss with health care providers , and prompts to make notes of any questions for the doctor . The booklets include pictures of patients and tables and graphs summarizing information . Content of iDecide The development process and content of the iDecide program have been described in detail elsewhere ( 32 ) . Briefly , we used community-based participatory research and user-centered design ( 33 , 34 ) principles to iteratively develop and refine the iDecide tool . iDecide is available in English and Spanish , can be delivered via tablet computers , and enables navigation by the CHW and participant to selectively explore issues most important to the participant . The iDecide program is organized into 4 main sections and includes the same content as the AHRQ consumer guides . However , its information is presented in a more graphical style suited to patients with low literacy . Table 1 summarizes key differences between the presentation of information in iDecide and the printed material s. The first section illustrates , through animations , how diabetes affects the way glucose is processed in the body and how different medication classes , foods , and physical activity affect blood glucose . The second section includes pictographs showing participants ' own risk for diabetes complications ( tailored according to their baseline HbA1c ) and enabling participants to explore how their risk for different complications changes with their HbA1c levels . In the third section , participants review their current diabetes medications and barriers to taking the medications they had reported on the baseline survey . This section includes an interactive issue card approach to help elicit patient preferences and priorities about different medication characteristics ( for example , cost , adverse effects , effects on weight , and dosing schedules ) ( 22 , 35 ) . The fourth section prompts participants to set goals and develop specific action plans to address identified barriers or other concerns and identify specific questions and concerns to discuss with their doctor about their medications or making lifestyle changes . Personal information from the baseline assessment is interwoven throughout the program ( high-depth tailoring within sentences ) . Motivational interviewingbased , tailored discussion prompts encourage autonomy-supportive CHWpatient interactions at key points with open-ended questions and values exploration to help participants discover their motivation , overcome barriers to change , and develop an action plan ( 36 ) . Table 1 . Comparison of Content and Mode of Delivery Between the iDecide Study Group and the Printed Material s Group Recruitment and R and omization From September 2011 to August 2012 , potentially eligible participants were identified from a computer-generated list of CHASS patients with physician-diagnosed type 2 diabetes . Inclusion criteria required a HbA1c value greater than 7.5 % in the previous 6 months or expressed concerns about current diabetes medications during the screen \n Output:\n " }, { "from": "agent", "value": "A strong majority of the literature shows positive effects of HIT on the effectiveness of medical outcomes , which positively supports efforts that prepare for stage 3 of meaningful use ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Recent reports have drawn attention to the importance of pulse pressure as a predictor of cardiovascular events . Pulse pressure is used neither by clinicians nor by guidelines to define treatable levels of blood pressure . METHODS In the Cardiovascular Health Study , 5888 adults 65 years and older were recruited from 4 US centers . At baseline in 1989 - 1990 , participants underwent an extensive examination , and all subsequent cardiovascular events were ascertained and classified . RESULTS At baseline , 1961 men and 2941 women were at risk for an incident myocardial infa rct ion or stroke . During follow-up that averaged 6.7 years , 572 subjects had a coronary event , 385 had a stroke , and 896 died . After adjustment for potential confounders , systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , and pulse pressure were directly associated with the risk of incident myocardial infa rct ion and stroke . Only SBP was associated with total mortality . Importantly , SBP was a better predictor of cardiovascular events than DBP or pulse pressure . In the adjusted model for myocardial infa rct ion , a 1-SD change in SBP , DBP , and pulse pressure was associated with hazard ratios ( 95 % confidence intervals ) of 1.24 ( 1.15 - 1.35 ) , 1.13 ( 1.04 - 1.22 ) , and 1.21 ( 1.12 - 1.31 ) , respectively ; and adding pulse pressure or DBP to the model did not improve the fit . For stroke , the hazard ratios ( 95 % confidence intervals ) were 1.34 ( 1.21 - 1.47 ) with SBP , 1.29 ( 1.17 - 1.42 ) with DBP , and 1.21 ( 1.10 - 1.34 ) with pulse pressure . The association between blood pressure level and cardiovascular disease risk was generally linear ; specifically , there was no evidence of a J-shaped relationship . In those with treated hypertension , the hazard ratios for the association of SBP with the risks for myocardial infa rct ion and stroke were less pronounced than in those without treated hypertension . CONCLUSION In this population -based study of older adults , although all measures of blood pressure were strongly and directly related to the risk of coronary and cerebrovascular events , SBP was the best single predictor of cardiovascular events The effect of conventional propranolol and bendrofluazide tablets given twice daily has been compared with an equivalent dosage combined in a single capsule given twice daily in fourteen patients with essential hypertension . Good blood pressure control was achieved on both regimes in the majority of patients and there was no significant difference in treatment response between the two regimes . Use of the combined capsule is convenient and may improve patient compliance BACKGROUND Short-term studies have suggested that the use of initial combination therapy for the control of blood pressure improves early effectiveness . We tested whether a combination of aliskiren and amlodipine is superior to each monotherapy in early control of blood pressure without excess of adverse events , and if initial control by monotherapy impairs subsequent control by combination therapy . METHODS We did a double-blind , r and omised , parallel-group , superiority trial at 146 primary and secondary care sites in ten countries , with enrolment from Nov 28 , 2008 , to July 15 , 2009 . Patients eligible for enrolment had essential hypertension , were aged 18 years or older , and had systolic blood pressure between 150 and 180 mm Hg . Patients were r and omly assigned ( 1:1:2 ) to treatment with 150 mg aliskiren plus placebo , 5 mg amlodipine plus placebo , or 150 mg aliskiren plus 5 mg amlodipine . R and om assignment was through a central interactive voice response system and treatment allocation was masked from the patients . From 16 - 32 weeks , all patients received combination therapy with 300 mg aliskiren plus 10 mg amlodipine . Our primary endpoints , assessed on an intention-to-treat basis ( ie , in patients who received the allocated treatment ) , were the adjusted mean reduction in systolic blood pressure from baseline over 8 to 24 weeks , and then the final reduction at 24 weeks . This trial is registered with Clinical Trials.gov , number NCT00797862 . FINDINGS 318 patients were r and omly assigned to aliskiren , 316 to amlodipine , and 620 to aliskiren plus amlodipine . 315 patients initially allocated to aliskiren , 315 allocated to amlodipine , and 617 allocated to aliskiren plus amlodipine were available for analysis . Patients given initial combination therapy had a 6·5 mm Hg ( 95 % CI 5·3 to 7·7 ) greater reduction in mean systolic blood pressure than the monotherapy groups ( p<0·0001 ) . At 24 weeks , when all patients were on combination treatment , the difference was 1·4 mm Hg ( 95 % CI -0·05 to 2·9 ; p=0·059 ) . Adverse events caused withdrawal of 85 patients ( 14 % ) from the initial aliskiren plus amlodipine group , 45 ( 14 % ) from the aliskiren group , and 58 ( 18 % ) from the amlodipine group . Adverse events were peripheral oedema , hypotension , or orthostatic hypotension . INTERPRETATION We believe that routine initial reduction in blood pressure ( > 150 mm Hg ) with a combination such as aliskiren plus amlodipine can be recommended . FUNDING Novartis Pharma AG ABSTRACT Objective : Free combination hypertension medication is associated with a lower compliance and less persistence compared to fixed combination therapy and can , therefore , be associated with insufficient blood pressure reductions . This non-r and omized study investigated whether valsartan 160 mg/ hydrochlorothiazide 25 mg ( Val 160/HCTZ 25 ) in fixed dose combination could provide additional blood pressure control in hypertensive patients not adequately controlled by the free combination of c and esartan 32 mg plus HCTZ 25 mg . Research design and methods : One hundred and ninety-seven patients with a mean sitting diastolic blood pressure ( MSDBP ) between 100 and 110 mmHg entered a 4-week treatment phase with 32 mg of c and esartan in free combination with 25 mg of HCTZ once daily . One hundred and thirty-eight patients with uncontrolled BP at Week 4 , entered a second 4-week treatment phase with Val160/ HCTZ 25 once daily . Main outcome measures : The primary efficacy parameter was the reduction in MSDBP at trough between Week 4 and Week 8 in the intent-to-treat population . Results : At baseline , MSDBP was 103.0 ± 2.8 mmHg . After Week 4 , MSDBP had decreased to 93.8 ± 4.5 mmHg . Subsequent treatment with Val 160/HCTZ 25 for 4 weeks reduced MSDBP to 88.7 ± 8.6 mmHg . This represented an additional decrease in MSDBP of 5.1 ± 7.9 mmHg ( p < 0.0001 ) . Val 160/ HCTZ 25 reduced mean sitting systolic BP by 3.4 ± 13.0 mmHg ( p = 0.0029 ) . Conclusions : The fixed dose combination of valsartan 160/HCTZ 25 mg provided a statistically and clinical ly significant additional BP reduction in patients not controlled by the free combination of c and esartan 32 mg and HCTZ 25 mg The importance of number of tablets for patient compliance was investigated in 160 patients with mild-moderate essential hypertension treated with a beta-adrenoceptor blocker and a thiazide diuretic . Mean BP at entry 146 + /- 16/92 + /- 8 mm Hg . All patients were given pindolol 10 mg and clopamide 5 mg in one combination tablet or in separate tablets for 4 months respectively . Approximately 90 % of the patients took greater than 90 % of the prescribed dose throughout the study . Mean BP decreased progressively and heart rate increased slightly . Side effects were more frequently reported during the first month of the study than previously , and 30 patients discontinued the treatment . No differences in this respect were seen between 1 and 2 tablets daily . Approximately 75 % of the patients preferred 1 tablet daily , but combining two drugs in one tablet had no effect upon compliance OBJECTIVES To assess medication adherence , persistence , and costs between cohorts of patients in managed care setting s using a fixed-dose combination ( FDC ) or individual components ( IC ) of valsartan and hydrochlorothiazide in an insurance cl aims data base . METHODS Medical and prescription cl aims for hypertensive patients using a combination of valsartan and HCTZ were identified from the IHCIS National Managed Care Benchmark Data base via a retrospective cohort analysis . Study subjects had at least 110 days prior to start of study medications during which no other antihypertensive medications were prescribed , and were followed for 12 months . Cl aims for 8711 adult patients were analyzed for adherence , persistence and costs . General linear regression was conducted to detect differences in adherence among groups . Covariates included age , gender , persistence , number on concomitant cardiovascular drugs , and number of cardiovascular diagnoses . RESULTS Most subjects used an FDC product ( N=8150 , 93.6 % ) vs. the IC ( N=561 , 6.4 % ) . The FDC group had a larger portion of males and less concomitant cardiovascular medications or disease . A r and om sample of 1628 of the FDC subjects had improved values for medication adherence compared to the IC group ( 62.1 vs. 53.0 % , p<0.001 ) and persistence values were improved at both 180 days ( 73 vs. 28 % , p<0.001 ) and 365 days ( 54 vs. 19 % , p<0.001 ) . Both prescription drug costs ( $ 1587 vs. $ 2050 , p<0.001 ) and medical costs ( $ 3343 vs. $ 3817 , p<0.001 ) were lower in the FDC cohorts . CONCLUSIONS The use of fixed-dose therapy in hypertension may lead to increased adherence and persistence with a positive financial impact on both prescription and total medical costs . As with any retrospective cl aims data base analysis , unobserved systematic differences between the two medication groups may exist Most systematic review s rely substantially on the assessment of the method ological quality of the individual trials . The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of r and omized clinical trials ( RCTs ) . The invited participants were experts in the field of quality assessment of RCTs . The initial item pool contained all items from existing criteria lists . Subsequently , we reduced the number of items by using the Delphi consensus technique . Each Delphi round comprised a question naire , an analysis , and a feedback report . The feedback report included staff team decisions made on the basis of the analysis and their justification . A total of 33 international experts agreed to participate , of whom 21 completed all question naires . The initial item pool of 206 items was reduced to 9 items in three Delphi rounds . The final criteria list ( the Delphi list ) was satisfactory to all participants . It is a starting point on the way to a minimum reference st and ard for RCTs on many different research topics . This list is not intended to replace , but rather to be used alongside , existing criteria lists Background and Purpose — The benefits of antihypertensive ( AH ) drugs on the risks of major cardiovascular outcomes have been demonstrated in clinical trials . However , approximately half of hypertensive patients do not adhere well to their prescribed AH therapy in actual practice . The purpose of this study was to assess the impact of adherence to AH agents on the incidence of cerebrovascular disease ( CD ) in real-world practice . Methods — A cohort of 83 267 hypertensive patients was reconstructed from the Régie de l'assurance maladie du Québec data bases . Subjects included were between 45 and 85 years old , initially free of cardiovascular disease , and newly treated for hypertension with AH agents between 1999 and 2004 . A nested case – control design was conducted to study CD occurrence . Every case was matched for age and duration of follow-up with up to 15 r and omly selected control subjects . The adherence to AH drugs was measured by calculating the medication possession ratio . Conditional logistic regression models were performed to assess the association between adherence to AH agents and CD adjusting for various potential confounders . Results — At cohort entry , the mean patient age was 65 years , 37.3 % were male , 8.6 % had diabetes , and 19.5 % had dyslipidemia . High adherence ( ≥80 % ) to AH drugs significantly decreased the risk of CD by 22 % ( rate ratio , 0.78 ; 95 % CI , 0.70 to 0.87 ) compared with lower adherence \n Output:\n " }, { "from": "agent", "value": "For endpoints correlated with higher adherence ( e.g. , a reduction in blood pressure ) , a nonsignificant benefit was observed for FDCs .\nMoreover , it was demonstrated that higher adherence can lead to a lower risk of cardiovascular events .\nConclusions In comparison with FECs , the FDC treatment is associated with a significant improvement in the cooperation between a doctor and a patient and with increased patients ' adherence to the treatment schedule" } ]