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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: Objective To examine the prevalence of outcome reporting bias — the selection for publication of a subset of the original recorded outcome variables on the basis of the results — and its impact on Cochrane review s. Design A nine point classification system for missing outcome data in r and omised trials was developed and applied to the trials assessed in a large , unselected cohort of Cochrane systematic review s. Research ers who conducted the trials were contacted and the reason sought for the non-reporting of data . A sensitivity analysis was undertaken to assess the impact of outcome reporting bias on review s that included a single meta- analysis of the review primary outcome . Results More than half ( 157/283 ( 55 % ) ) the review s did not include full data for the review primary outcome of interest from all eligible trials . The median amount of review outcome data missing for any reason was 10 % , whereas 50 % or more of the potential data were missing in 70 ( 25 % ) review s. It was clear from the publications for 155 ( 6 % ) of the 2486 assessable trials that the research ers had measured and analysed the review primary outcome but did not report or only partially reported the results . For reports that did not mention the review primary outcome , our classification regarding the presence of outcome reporting bias was shown to have a sensitivity of 88 % ( 95 % CI 65 % to 100 % ) and specificity of 80 % ( 95 % CI 69 % to 90 % ) on the basis of responses from 62 trialists . A third of Cochrane review s ( 96/283 ( 34 % ) ) contained at least one trial with high suspicion of outcome reporting bias for the review primary outcome . In a sensitivity analysis undertaken for 81 review s with a single meta- analysis of the primary outcome of interest , the treatment effect estimate was reduced by 20 % or more in 19 ( 23 % ) . Of the 42 meta-analyses with a statistically significant result only , eight ( 19 % ) became non-significant after adjustment for outcome reporting bias and 11 ( 26 % ) would have overestimated the treatment effect by 20 % or more . Conclusions Outcome reporting bias is an under-recognised problem that affects the conclusions in a substantial proportion of Cochrane review s. Individuals conducting systematic review s need to address explicitly the issue of missing outcome data for their review to be considered a reliable source of evidence . Extra care is required during data extraction , review ers should identify when a trial reports that an outcome was measured but no results were reported or events observed , and contact with trialists should be encouraged In clinical measurement comparison of a new measurement technique with an established one is often needed to see whether they agree sufficiently for the new to replace the old . Such investigations are often analysed inappropriately , notably by using correlation coefficients . The use of correlation is misleading . An alternative approach , based on graphical techniques and simple calculations , is described , together with the relation between this analysis and the assessment of repeatability Background Systematic review s ( SRs ) can help decision makers interpret the deluge of published biomedical literature . However , a SR may be of limited use if the methods used to conduct the SR are flawed , and reporting of the SR is incomplete . To our knowledge , since 2004 there has been no cross-sectional study of the prevalence , focus , and completeness of reporting of SRs across different specialties . Therefore , the aim of our study was to investigate the epidemiological and reporting characteristics of a more recent cross-section of SRs . Methods and Findings We search ed MEDLINE to identify potentially eligible SRs indexed during the month of February 2014 . Citations were screened using prespecified eligibility criteria . Epidemiological and reporting characteristics of a r and om sample of 300 SRs were extracted by one review er , with a 10 % sample extracted in duplicate . We compared characteristics of Cochrane versus non-Cochrane review s , and the 2014 sample of SRs versus a 2004 sample of SRs . We identified 682 SRs , suggesting that more than 8,000 SRs are being indexed in MEDLINE annually , corresponding to a 3-fold increase over the last decade . The majority of SRs addressed a therapeutic question and were conducted by authors based in China , the UK , or the US ; they included a median of 15 studies involving 2,072 participants . Meta- analysis was performed in 63 % of SRs , mostly using st and ard pairwise methods . Study risk of bias/ quality assessment was performed in 70 % of SRs but was rarely incorporated into the analysis ( 16 % ) . Few SRs ( 7 % ) search ed sources of unpublished data , and the risk of publication bias was considered in less than half of SRs . Reporting quality was highly variable ; at least a third of SRs did not report use of a SR protocol , eligibility criteria relating to publication status , years of coverage of the search , a full Boolean search logic for at least one data base , methods for data extraction , methods for study risk of bias assessment , a primary outcome , an abstract conclusion that incorporated study limitations , or the funding source of the SR . Cochrane SRs , which accounted for 15 % of the sample , had more complete reporting than all other types of SRs . Reporting has generally improved since 2004 , but remains suboptimal for many characteristics . Conclusions An increasing number of SRs are being published , and many are poorly conducted and reported . Strategies are needed to help reduce this avoidable waste in research A report of a r and omized , controlled trial ( RCT ) should convey to the reader , in a transparent manner , why the study was undertaken and how it was conducted and analyzed . For example , a lack of adequately reported r and omization has been associated with bias in estimating the effectiveness of interventions ( 1 , 2 ) . To assess the strengths and limitations of an RCT , readers need and deserve to know the quality of its methods . Despite several decades of educational efforts , RCTs still are not being reported adequately ( 3 - 6 ) . For example , a review of 122 recently published RCTs that evaluated the effectiveness of selective serotonin-reuptake inhibitors as first-line management strategy for depression found that only 1 ( 0.8 % ) paper described r and omization adequately ( 5 ) . Inadequate reporting makes the interpretation of RCT results difficult if not impossible . Moreover , inadequate reporting borders on unethical practice when biased results receive false credibility . History of CONSORT In the mid-1990s , two independent initiatives to improve the quality of reports of RCTs led to the publication of the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement ( 7 ) , which was developed by an international group of clinical trialists , statisticians , epidemiologists , and biomedical editors . CONSORT has been supported by a growing number of medical and health care journals ( 8 - 11 ) and editorial groups , including the International Committee of Medical Journal Editors ( ICMJE , also known as the Vancouver Group ) ( 12 ) , the Council of Science Editors ( CSE ) , and the World Association of Medical Editors ( WAME ) . CONSORT is also published in Dutch , English , French , German , Japanese , and Spanish . It can be accessed on the Internet , along with other information about the CONSORT group ( 13 ) . The CONSORT statement comprises a checklist and flow diagram for reporting an RCT . For convenience , the checklist and diagram together are called simply CONSORT . They are primarily intended for use in writing , review ing , or evaluating reports of simple two-group , parallel RCTs . Preliminary data indicate that the use of CONSORT does indeed help to improve the quality of reports of RCTs ( 14 , 15 ) . In an evaluation ( 14 ) of 71 RCTs published in three journals in 1994 , allocation concealment was not clearly reported in 43 ( 61 % ) of the RCTs . Four years later , after these three journals required that authors reporting an RCT use CONSORT , the proportion of papers in which allocation concealment was not clearly reported had dropped to 39 % ( 30 of 77 ; mean difference , 22 % [ 95 % CI of the difference , 38 % to 6 % ] ) . The usefulness of CONSORT is enhanced by continuous monitoring of the biomedical literature ; this monitoring allows CONSORT to be modified depending on the merits of maintaining or dropping current items and including new items . For example , when Meinert ( 16 ) observed that the flow diagram did not provide important information about the number of participants who entered each phase of an RCT ( enrollment , treatment allocation , follow-up , and data analysis ) , the diagram could be modified to accommo date the information . The checklist is similarly flexible . This iterative process makes the CONSORT statement a continually evolving instrument . While participants in the CONSORT group and their degree of involvement vary over time , members meet regularly to review the need to refine CONSORT . At the 1999 meeting , the participants decided to revise the original statement . This report reflects changes determined by consensus of the CONSORT group , partly in response to emerging evidence on the importance of various elements of RCTs . Revision of the CONSORT Statement Thirteen members of the CONSORT group met in May 1999 with the primary objective of revising the original CONSORT checklist and flow diagram , as needed . The group discussed the merits of including each item in the light of current evidence . As in developing the original CONSORT statement , our intention was to keep only those items deemed fundamental to reporting st and ards for an RCT . Some items not considered essential may well be highly desirable and should still be included in an RCT report even though they are not included in CONSORT . Such items include approval of an institutional ethical review board , sources of funding for the trial , and a trial registry number ( as , for example , the International St and ard R and omized Controlled Trial Number [ IS RCT N ] used to register an RCT at its inception [ 17 ] ) . Shortly after the meeting , a revised version of the checklist was circulated to the group for additional comments and feedback . Revisions to the flow diagram were similarly made . All these changes were discussed when CONSORT participants met in May 2000 , and the revised statement was finalized shortly afterward . The revised CONSORT statement includes a 22-item checklist ( Table ) and a flow diagram ( Figure ) . Its primary aim is to help authors improve the quality of reports of simple two-group , parallel RCTs . However , the basic philosophy underlying the development of the statement can be applied to any design . In this regard , additional statements for other design s will be forthcoming from the group ( 13 ) . CONSORT can also be used by peer review ers and editors to identify reports with inadequate description of trials and those with potentially biased results ( 1 , 2 ) . Table . Checklist of Items To Include When Reporting a R and omized Trial Figure . Flow diagram of the progress through the phases of a r and omized trial ( enrollment , intervention allocation , follow-up , and data analysis ) . During the 1999 meeting , the group also discussed the benefits of developing an explanatory document to enhance the use and dissemination of CONSORT . The document is patterned on reporting of statistical aspects of clinical research ( 18 ) , which was developed to help facilitate the recommendations of the ICMJE 's Uniform Requirements for Manuscripts Su bmi tted to Biomedical Journals . Three members of the CONSORT group , with assistance from members on some checklist items , drafted an explanation and elaboration document . That document ( 19 ) was circulated to the group for additions and revisions and was last revised after review at the latest CONSORT group meeting . Changes to CONSORT 1 . In the revised checklist , a new column for Paper Section and Topic integrates information from the Subheading column that was contained in the original statement . 2 . The Was It Reported ? column has been integrated into a Reported on Page Number column , as requested by some journals . 3 . Each item of the checklist is now numbered , and the syntax and order have been revised to improve the flow of information . 4 . Title and Abstract are now combined in the first item . 5 . While the content of the revised checklist is similar to that of the original one , some items that previously were combined are now separate . For example , authors had been asked to describe primary and secondary outcome ( s ) measure(s ) and the minimum important difference(s ) , and indicate how the target sample size was projected . In the new version , issues pertaining to outcomes ( item 6 ) and sample size ( item 7 ) are separate , enabling authors to be more explicit about each . Moreover , some items request additional information . For example , for outcomes ( item 6 ) authors are asked to report any methods used to enhance the quality of measurements , such as multiple observations . 6 . The item asking for the unit of r and omization ( for example , cluster ) has been dropped because specific checklists have been developed for reporting cluster RCTs ( 20 ) and other design types ( 13 ) since publication of the original checklist . 7 . Whenever possible , new evidence is incorporated into the revised checklist . For example , authors are asked to be explicit about whether the analysis reported is by intention to treat ( item 16 ) . This request is based in part on the observations ( 21 ) that authors do not adequately describe and apply intention-to-treat analysis and that reports not providing this information are less likely to provide other relevant information , such as losses to follow-up ( 22 ) . 8 . The revised flow diagram depicts information from four stages of a trial ( enrollment , intervention allocation , follow-up , and analysis ) . The revised diagram explicitly includes the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers lets the reader know whether the authors have performed an intention-to-treat analysis ( 21 - 23 ) . Because some of the information may not always be known and to accommo date other information , the structure of the flow diagram may need to be modified for a particular trial . Inclusion of the participant flow diagram in the report is strongly recommended but may be unnecessary for simple trials , such as those without any participant withdrawals or dropouts . Discussion Specifically developed to guide authors about how to improve the quality of reporting of simple two-group , parallel RCTs , CONSORT encourages transparency with reporting of the methods and results so that reports of RCTs can be interpreted both readily and accurately . However , CONSORT does not address other facets of reporting that also require attention , \n Output:\n " }, { "from": "agent", "value": "On average , meta- analysis HRs from published AD slightly tended to favour the research interventions whether based on fixed-effect ( HRAD to HRIPD ratio = 0.97 , p = 0.088 ) or r and om-effects ( HRAD to HRIPD ratio = 0.96 , p = 0.044 ) models , but the limits of agreement show that for individual meta-analyses , agreement was much more variable .\nWe utilised the results to construct a decision tree for assessing whether an AD meta- analysis includes sufficient information , and when estimates of effects are most likely to be reliable .\nIn this study we found that HRs from published AD were most likely to agree with those from IPD when the information size was large ." } ]

[ { "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: AIM Oral health is a reflection of general health and significantly influences the quality of life . Dental caries is one of the most common chronic diseases of childhood which may adversely affect physical , mental and social growth of children . Oral hygiene methods can effectively prevent oral and dental diseases , and oral hygiene education plays an important role in this regard . The aim of the present study was then to assess the effect of oral hygiene education on the oral and dental health of 6-year-olds . MATERIAL S AND METHODS A hundred and sixty 6-year-old children from 4 pre-school centers were divided into two groups , case and control , in this cluster r and omised controlled trail . The children in the case group received oral and dental education in one session . The parents of the case group were also instructed in one session . The children and parents of the control group did not receive any instructions . Plaque index ( PI ) : Turesky-Gilmore-Glickman ; gingival index ( GI ) : Loe & Silness ; at a ) baseline , b ) 1.5 and c ) 6 months after the first examination . Data were analysed by repeated measure ANOVA . RESULTS PI : A significant difference was found between the baseline examination and the first follow-up ( p < 0.01 ) , and between the baseline examination and the second follow-up ( p < 0.001 ) . GI : Although values in the case group were lower , no statistically significant difference was found between the two groups and within each group ( p > 0.05 ) . Regarding the number of brushing times , a statistically significant difference was found between the first and the second follow-ups of the study groups ( p > 0.05 ) . The brushing type and the application of other hygienic measures did not show any difference ( p > 0.05 ) . CONCLUSION Within the limitations of the present study it may be concluded that oral hygiene instruction to 6-year-old children and their parents improves their dental health Background School based oral health education through traditional lecturing has been found successful only in improving oral health knowledge , while has low effectiveness in oral hygiene and gingival health . The aim of this study was to evaluate the effectiveness of experiential learning ( EL ) oral health education to traditional lecturing ( TL ) , on enhancing oral health knowledge , attitude and behavior as well as oral hygiene , gingival health and caries of 10-year-old children . Methods Eighty-four children were recruited for the EL and 100 for the TL group from 3 locations in Greece . Data regarding oral health knowledge , attitude and behavior were collected via question naires . Data regarding dental plaque , gingivitis and caries were collected by clinical examination . The evaluation using question naires and clinical examination was assessed at baseline and 6 and 18 months afterwards . Two calibrated pediatric dentists examined the students using a periodontal probe and artificial light . Modified hygiene index ( HI ) was used for dental plaque recording , the simplified gingival index ( GI-S ) was used for gingivitis and DMFT , based on BASCD criteria , for dental caries . Based on a dedicated manual , the teacher applied in the classroom the oral health educational program using EL . Results EL group had statistically significant better hygiene than the TL at 6 months ( p < 0.05 ) . Within the same group , both groups had enhanced oral health knowledge at 6 and 18 months ( p < 0.05 ) and improved oral health behavior ( p > 0.05 ) and attitude ( p > 0.05 ) at 6 months in comparison to baseline . Conclusion EL program was found more successful than TL in oral hygiene improvement . Both oral health education programs improved the oral health knowledge , attitude and behavior of children . Trial registration Clinical Trials.gov ( NCT02320162 ) OBJECTIVES The aim of this study was to evaluate the effect of a 6-year oral health education programme in primary schoolchildren . METHODS This programme was part of the Signal-T and mobiel project , a longitudinal collaborative project combining the registration of oral health data and oral health promotion . The intervention group comprised 3291 children with a mean age of 7.1 years ( SD 0.43 ) at the start of the programme . Every year these children were examined clinical ly and a question naire , to be filled in by the parents , was administered to assess oral health behaviour . These children received an oral health education programme which consisted of a yearly 1-h instruction . Data collected using the same question naire and clinical examination in 676 12-year-old children were included as control group . The sample s were obtained using stratified cluster sampling . The effect of the interventional programme was assessed by measuring differences in caries prevalence and incidence , levels of dental care and reported oral health behaviour . RESULTS Mean DMFT/S values , although higher in the control group , were not significantly different . The reported frequency of brushing was the same in both groups . Significant differences in favour of the intervention group were found in the number of between-meal snacks ( P < 0.001 ) and the proper use of topical fluorides ( P < 0.05 ) . Children in the control group showed a significantly lower proportion of filled teeth than those in the intervention group ( P < 0.01 ) , with a care index of 73 % versus 80 % . CONCLUSION In conclusion , the implemented minimal school-based oral health education programme did not result in a significant reduction of the caries prevalence measured . The programme has been effective in improving reported dietary habits and the proper use of topical fluorides and result ed in a higher care index OBJECTIVE The aim of this study is to assess the impact of three different health education methods among preschoolers . STUDY DESIGN The study group included 100 preschoolers of the same socio-economic status r and omly selected and divided into four groups . Debris index ( DI-S ) was recorded for all children followed by the dental health education . Group A received dental health education from the Dentist ; Group B from the class teacher trained by the Dentist and Group C from the dental residents dressed mimicking cartoon characters . Group D acted as the control group . Post-intervention evaluation program was carried out after 3 months . Data were analyzed by Chi-square test , paired t-test and analysis of variance ( ANOVA ) appropriately using the SPSS Version 17.1 . RESULTS Comparison of pre- and post-intervention data showed that there was a statistically significant improvement in the ( DI-S ) scores in all groups except the control group . Group C showed a significant improvement compared to the other Groups A , B , and D ( P<0.04 ) . CONCLUSION Drama as a method of health education can have a bigger impact on the oral health attitude and practice s of the preschoolers . These modes can serve to reinforce as well as improve the oral health practice s among pre-school children Background Oral health education ( OHE ) in schools has largely been imparted by dental professionals . Considering the substantial cost of this expert-led approach , the strategies relying on teachers , peer-leaders and learners themselves have also been utilized . However the evidence for comparative effectiveness of these strategies is lacking in the dental literature . The present study was conducted to compare the effectiveness of dentist-led , teacher-led , peer-led and self-learning strategies of oral health education . Methods A two-year cluster r and omized controlled trial following a parallel design was conducted . It involved five groups of adolescents aged 10 - 11 years at the start of the study . The trial involved process as well as four outcome evaluations . The present paper discusses the findings of the study pertaining to the baseline and final outcome evaluation , both comprising of a self-administered question naire , a structured interview and clinical oral examination . The data were analyzed using Generalized Estimating Equations . Results All the three educator-led strategies of OHE had statistically higher mean oral health knowledge ( OHK ) , oral health behavior ( OHB ) , oral hygiene status ( OHS ) and combined knowledge , behavior and oral hygiene status ( KBS ) scores than the self-learning and control groups ( p<0.001 ) . The mean OHK , OHS and KBS scores of the three educator-led strategies did not differ significantly . The peer-led strategy was , however , found to have a significantly better OHB score than the respective score of the teacher-led strategy ( p<0.05 ) . The self-learning group had significantly higher OHB score than the control group ( p<0.05 ) but the OHK , OHS and KBS scores of the two groups were not significantly different . Conclusions The dentist-led , teacher-led and peer-led strategies of oral health education are equally effective in improving the oral health knowledge and oral hygiene status of adolescents . The peer-led strategy , however , is almost as effective as the dentist-led strategy and comparatively more effective than the teacher-led and self-learning strategies in improving their oral health behavior . Trail registration S RCT The aim of our study was to compare the changes in children 's oral health-related behavior , knowledge , and attitudes obtained using an oral health-promotion approach , a risk- strategy and promotion approach , and reference area , and to report changes in the behavior of children between the experimental and the control groups of a r and omized clinical trial ( RCT ) . The study population consisted of all fifth and sixth grade rs who started the 2001 - 2002 school year in Pori , Finl and ( n = 1,691 ) , where the RCT and program of oral health promotion were implemented for 3.4 yr . Children with at least one active caries lesion were r and omly assigned to experimental ( n = 250 ) and control ( n = 247 ) groups . Children in Rauma ( n = 807 ) acted as the reference . Changes in children 's self-reported behavior , knowledge , and attitudes were compared between groups . The subjects in the oral health-promotion group and in the risk- strategy and promotion group in Pori tended to show greater improvement in most of their oral health-related behaviors than those in the reference group , and children in the RCT experimental group showed greater improvement in most of their oral health-related behaviors than those in the RCT control group . Children can be helped to improve their oral health-related behavior by intervention , including oral hygiene and dietary counseling , or by implementing a multilevel-approach oral health-promotion program Non-r and omised studies of the effects of interventions are critical to many areas of healthcare evaluation , but their results may be biased . It is therefore important to underst and and appraise their strengths and weaknesses . We developed ROBINS-I ( “ Risk Of Bias In Non-r and omised Studies - of Interventions ” ) , a new tool for evaluating risk of bias in estimates of the comparative effectiveness ( harm or benefit ) of interventions from studies that did not use r and omisation to allocate units ( individuals or clusters of individuals ) to comparison groups . The tool will be particularly useful to those undertaking systematic review s that include non-r and omised studies The purpose of the study was to assess the outcome of school‐based oral health education ( OHE ) and a sugar‐free chewing gum program on the oral health status of children in terms of reduced caries increment and gingival bleeding over a period of 2 years . Nine primary schools r and omly chosen from one district were divided into three groups : OHE group ( Group E ) , sugar‐free chewing gum in addition to OHE group ( Group G ) , and the control group ( Group C ) . All children of grade 1 ( aged 6–7 years ) were recruited ( n = 1342 ) . After 2 years , 1143 children remained in the study group at follow‐up . The overall drop‐out rate was about 15 % . Data on dental caries and gingival bleeding were collected by clinical examination . The results showed that the mean increment of DMFS in Group G was 42 % lower than in groups E and C ( P < 0.05 ) . The mean increments in F‐S were higher in Groups G and E than in Group C ( P < 0.01 ) . The gingival bleeding scores were statistically significant among the three groups . Compared to Group C , the mean increment in bleeding scores of Group G was 71 % lower ( P < 0.01 ) and in Group E 42 % lower ( P < 0.05 ) . The school‐based OHE programs had some positive effect improving children 's oral hygiene ; in certain circumstances children may benefit from using polyol‐containing chewing gum in terms of reduced dental caries OBJECTIVES To assess the outcome of oral health promotion in schoolchildren over a 3-year period in Yichang City , Hubei , China . METHODS In a cluster r and omized controlled trial , the concept of the World Health Organization Health Promoting Schools Project was applied to primary schoolchildren . Seven intervention schools and eight control schools were r and omly selected from one district by stratified cluster sampling . The study was conducted as a 3-year follow-up study . After 3 years , 661 children remained in the intervention group and 697 children in the control group . Data on dental caries , plaque accumulation , and sulcus bleeding were collected by clinical examination , while behavioural data were gathered by self-administered question naires . RESULTS The 3-year net mean DMFS increment score was 0.22 in the intervention schools and 0.35 in the control schools ( P < 0.013 ) . A statistically significant difference in mean plaque ( P < 0.013 ) and sulcus bleeding ( P < 0.005 ) increment scores after 3 years was found between the two groups . Statistically significant higher scores were observed in restorations received and sealants placed , and a lower score in untreated dental caries , in children from the intervention group than the control group after 3 years ( P < 0.01 ) . In addition , more children in the intervention schools adopted regular oral health behavioural practice s such as brushing their teeth at least twice a day , visiting the dentist within the past calendar year , and using fluoride toothpaste . CONCLUSION The study suggests that the school-based oral health promotion was an effective way to reduce \n Output:\n " }, { "from": "agent", "value": "Oral health-related knowledge improved in children .\nOral health-related practice behaviors such as frequency and duration of brushing improved .\nUse of fluori date d toothpaste was increased .\nPlaque scores and gingival bleeding scores reduced .\nConclusion : School dental health education had a positive impact on the oral health status , knowledge , and practice behavior of children ." } ]

[ { "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 Septic shock is one of the most frequent causes of admission to the intensive care unit ( ICU ) and is associated with a poor prognosis . Early and late death in septic shock should be distinguished because they may involve different underlying mechanisms . In various conditions , the neutrophil-to-lymphocyte count ratio ( NLCR ) has been described as an easily measurable parameter to express injury severity . In the present study , we investigated whether the timing of death was related to a particular NLCR . Methods We conducted a prospect i ve , single-center , observational study that included consecutive septic shock patients . Severity scores , early ( before day 5 ) or late ( on or after day 5 of septic shock onset ) ICU mortality , and daily leukocyte counts were collected during the ICU stay . We assessed the association between leukocyte counts at admission and their evolution during the first 5 days with early or late death . The association between patient characteristics ( including cell counts ) and prognosis was estimated using Cox proportional cause-specific hazards models . Results The study included 130 patients who were diagnosed with abdominal ( n = 99 ) or extra-abdominal ( n = 31 ) septic shock . The median ( interquartile range ) NLCR was 12.5 ( 6.5–21.2 ) in survivors and 6.2 ( 3.7–12.6 ) in nonsurvivors ( p = 0.001 ) . The NLCR at admission was significantly lower in patients who died before day 5 than in survivors ( 5 [ 3.5–11.6 ] versus 12.5 [ 6.5–21.2 ] , respectively ; p = 0.01 ) . From day 1 to day 5 , an increased NLCR related to an increase in neutrophil count and a decrease in lymphocyte count was associated with late death ( + 34.8 % [ −8.2 to 305.4 ] versus −20 % [ −57.4 to 45.9 ] ; p = 0.003 ) . Those results were present in patients with abdominal origin sepsis as well as in those with extra-abdominal sepsis , who were analyzed separately . Conclusions In the present study , a reversed NLCR evolution was observed according to the timing of death . Septic shock patients at risk of early death had a low NLCR at admission , although late death was associated with an increased NLCR during the first 5 days Patients with sepsis have impaired host defenses that contribute to the lethality of the disorder . Recent work implicates lymphocyte apoptosis as a potential factor in the immunosuppression of sepsis . If lymphocyte apoptosis is an important mechanism , specific subsets of lymphocytes may be more vulnerable . A prospect i ve study of lymphocyte cell typing and apoptosis was conducted in spleens from 27 patients with sepsis and 25 patients with trauma . Spleens from 16 critically ill nonseptic ( 3 prospect i ve and 13 retrospective ) patients were also evaluated . Immunohistochemical staining showed a caspase-9-mediated profound progressive loss of B and CD4 T helper cells in sepsis . Interestingly , sepsis did not decrease CD8 T or NK cells . Although there was no overall effect on lymphocytes from critically ill nonseptic patients ( considered as a group ) , certain individual patients did exhibit significant loss of B and CD4 T cells . The loss of B and CD4 T cells in sepsis is especially significant because it occurs during life-threatening infection , a state in which massive lymphocyte clonal expansion should exist . Mitochondria-dependent lymphocyte apoptosis may contribute to the immunosuppression in sepsis by decreasing the number of immune effector cells . Similar loss of lymphocytes may be occurring in critically ill patients with other disorders Introduction The neutrophil-to-lymphocyte ratio ( NLR ) is a biological marker that has been shown to be associated with outcomes in patients with a number of different malignancies . The objective of this study was to assess the relationship between NLR and mortality in a population of adult critically ill patients . Methods We performed an observational cohort study of unselected intensive care unit ( ICU ) patients based on records in a large clinical data base . We computed individual patient NLR and categorized patients by quartile of this ratio . The association of NLR quartiles and 28-day mortality was assessed using multivariable logistic regression . Secondary outcomes included mortality in the ICU , in-hospital mortality and 1-year mortality . An a priori subgroup analysis of patients with versus without sepsis was performed to assess any differences in the relationship between the NLR and outcomes in these cohorts . Results A total of 5,056 patients were included . Their 28-day mortality rate was 19 % . The median age of the cohort was 65 years , and 47 % were female . The median NLR for the entire cohort was 8.9 ( interquartile range , 4.99 to 16.21 ) . Following multivariable adjustments , there was a stepwise increase in mortality with increasing quartiles of NLR ( first quartile : reference category ; second quartile odds ratio ( OR ) = 1.32 ; 95 % confidence interval ( CI ) , 1.03 to 1.71 ; third quartile OR = 1.43 ; 95 % CI , 1.12 to 1.83 ; 4th quartile OR = 1.71 ; 95 % CI , 1.35 to 2.16 ) . A similar stepwise relationship was identified in the subgroup of patients who presented without sepsis . The NLR was not associated with 28-day mortality in patients with sepsis . Increasing quartile of NLR was statistically significantly associated with secondary outcome . Conclusion The NLR is associated with outcomes in unselected critically ill patients . In patients with sepsis , there was no statistically significant relationship between NLR and mortality . Further investigation is required to increase underst and ing of the pathophysiology of this relationship and to vali date these findings with data collected prospect ively BACKGROUND The neutrophil-to-lymphocyte ratio is an independent predictor of worse prognosis in both infectious and cardiovascular disease . We hypothesized that an increased neutrophil-to-lymphocyte ratio at admission would predict in-hospital unfavourable outcomes in patients with infective endocarditis ( IE ) . METHODS We retrospectively analyzed clinical , laboratory , and echocardiographic data in a total of 121 consecutive adult patients ( 64 men ; mean age , 54.7 ± 14.2 years ) with definite IE . RESULTS Among all patients , the prespecified clinical outcomes were experienced in 46 patients ( 38 % ) . In-hospital mortality and central nervous system ( CNS ) events occurred in 29 ( 24 % ) and 21 patients ( 17 % ) , respectively . The neutrophil-to-lymphocyte ratio at admission was found to be significantly higher for either composite end point . On using multiple Cox regression analysis , vegetation size ≥ 10 mm , end-stage renal disease , Staphylococcus aureus infection , low hemoglobin level , increased C-reactive protein ( CRP ) level , and high neutrophil-to-lymphocyte ratio at admission emerged as independent predictors of in-hospital unfavourable outcomes . In the receiver operating characteristics ( ROC ) curve analysis , a neutrophil-to-lymphocyte ratio > 7.1 had 80 % sensitivity and 83 % specificity in predicting adverse outcomes . CONCLUSION High neutrophil-to-lymphocyte ratio at admission is an independent predictor of in-hospital mortality and CNS events in patients with IE . However , prospect i ve validation of these findings is required OBJECTIVE Infection with the bacterial pathogen Helicobacter pylori ( HP ) clearly results in chronic mucosal inflammation in the stomach and duodenum , which , in turn , might lead to abnormalities in gastroduodenal motility and sensitivity and is the most frequent cause of dyspepsia and peptic disease . Some studies have shown that there was a correlation between low- grade inflammation as C-reactive protein ( CRP ) and HP infection . The aim of this study was to investigate the relationship between the presence of gastritis due to HP infection and neutrophil/lymphocyte ratio ( NLR ) , a simple and reliable indicator of inflammation . DESIGN Fifty patients met the HP criteria and half of them have had severe symptoms and upper endoscopy showed atrophic gastritis , and fifty age- and sex-matched control subjects with gastritis without HP infection were included in this r and omized controlled trial . Patients were diagnosed to have HP according to the use of urea breath testing ( UBT ) and multiple biopsies . NLR was calculated from complete blood count at the time of diagnosis and before initiating the treatment to all groups . RESULTS Patients with HP infection had significantly higher NLR compared to those without HP . Moreover , the patients with symptomatic HP and grade 4 gastritis had higher NLR than those asymptomatic with past history of peptic disease ( P 0.007 and P 0.068 , respectively ) . Although NLR increased as the severity of gastritis and HP symptoms increased ( r = 0.564 , P < 0.001 ) , Receiver operating characteristic ( ROC ) Curve analysis was performed . The cut-off level for NLR with optimal sensitivity and specificity was calculated as 1.82 ( area under curve [ AUC ] = 0.825 [ 0.753 - 0.884 ] , P < 0.001 ) . CONCLUSION The present study indicated , for the first time , a significant correlation between HP infection and inflammation on the basis of NLR , a simple and reliable indicator of inflammation . Furthermore , there is an increase in NLR as the severity of gastritis with HP increases . This elevated ratio gets normalized with treatment Lymphopenia and lymphoid depletion occur in adults dying of sepsis . Prolactin increases Bcl-2 expression , suppresses stress-induced lymphocyte apoptosis , and improves survival from experimental sepsis . We hypothesized that prolonged lymphopenia , lymphoid depletion , and hypoprolactinemia occur in children dying with sepsis and multiple organ failure ( MOF ) . Fifty-eight critically ill children with and 55 without MOF admitted to a university hospital pediatric intensive care unit were enrolled in a prospect i ve , longitudinal , observational clinical study . Prolactin levels and absolute lymphocyte count were measured on days 1 , 3 , 7 , 14 , and 21 . Lymph node , thymus , and spleen autopsy specimens were examined for lymphoid depletion , with immunohistochemical staining for CD4 , CD20 , and CD21 and for lymphoid apoptosis . Prolonged lymphopenia ( absolute lymphocyte count < 1000 for > 7 days ) occurred only in children with MOF ( 29 vs 0 % , p < 0.05 ) and was associated independently with nosocomial infection ( odds ratio ( OR ) , 5.5 , 95 % confidence interval ( CI ) , 1.7–17 , p < 0.05 ) , death ( OR , 6.8 , 95 % CI , 1.3–34 , p < 0.05 ) , and splenic and lymph node hypocellularity ( OR , 42 , 95 % CI , 3.7–473 , p < 0.05 ) . Lymphocyte apoptosis and ante/postmortem infection were observed only in children with lymphoid depletion . Prolonged hypoprolactinemia ( > 7 days ) was more common in children with MOF ( 17 vs 2 % , p < 0.05 ) and was associated independently with prolonged lymphopenia ( OR , 8.3 , 95 % CI , 2.1–33 , p < 0.05 ) and lymphoid depletion ( OR , 12.2 , 95 % CI , 2.2–65 , p < 0.05 ) . Prolonged lymphopenia and apoptosis-associated depletion of lymphoid organs play a role in nosocomial sepsis-related death in critically ill children . Prolonged hypoprolactinemia is a previously unrecognized risk factor for this syndrome Although the sensitivity and specificity of the Duke criteria for the diagnosis of infective endocarditis ( IE ) have been vali date d by investigators from Europe and the United States , several shortcomings of this schema remain . The Duke IE data base contains records collected prospect ively on > 800 cases of definite and possible IE since 1984 . Data bases on echocardiograms and on patients with Staphylococcus aureus bacteremia at Duke University Medical Center are also maintained . Analyses of these data bases , our experience with the Duke criteria in clinical practice , and analysis of the work of others have led us to propose the following modifications of the Duke schema . The category \" possible IE \" should be defined as having at least 1 major criterion and 1 minor criterion or 3 minor criteria . The minor criterion \" echocardiogram consistent with IE but not meeting major criterion \" should be eliminated , given the widespread use of transesophageal echocardiography ( TEE ) . Bacteremia due to S. aureus should be considered a major criterion , regardless of whether the infection is nosocomially acquired or whether a removable source of infection is present . Positive Q-fever serology should be changed to a major criterion Study Objective The neutrophil-lymphocyte count ratio ( NLCR ) has been identified as a predictor of bacteremia in medical emergencies . The aim of this study was to investigate the value of the NLCR in patients with community \n Output:\n " }, { "from": "agent", "value": "Potential clinical utility was also demonstrated in pneumonia ( NLR ) , pertussis ( NLR ) , urinary tract infection ( NLR ) , diabetic foot infections ( NLR ) and Crimean Congo Haemorrhagic Fever ( PLR ) .\nLongitudinal measurement of LMR during respiratory virus infection reflected symptoms and NLR during sepsis and bacteraemia predicted mortality .\nConclusions Peripheral blood leucocyte ratios are useful infection biomarkers , with the most evidence related to diagnosis of bacteraemia and influenza virus infection ." } ]

[ { "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: Reports of cluster r and omised trials require additional information to allow readers to interpret them accurately The effective reporting of r and omised controlled trials has received useful attention in recent years . Many journals now require that reports conform to the guidelines in the Consoli date d St and ards of Reporting Trials ( CONSORT ) statement , first published in 1996 and revised in 2001 . The statement includes a checklist of items that should be included in the trial report . These items are evidence based whenever possible and are regularly review ed . The statement also recommends including a flow diagram to show the flow of participants from group assignment through to the final analysis . The CONSORT statement focused on reporting parallel group r and omised trials in which individual participants are r and omly assigned to study groups . However , in some situations it is preferable to r and omly assign groups of individuals ( such as families or medical practice s ) rather than individuals . Reasons include the threat of contamination of some interventions ( such as dietary interventions ) if individual r and omisation is used . 5 Also , in certain setting s r and omisation by group may be the only feasible method of conducting a trial . Trials with this design are variously known as field trials , community based trials , place based trials , or ( as in this paper ) cluster r and omised trials . In an earlier discussion paper we considered the implication s of the CONSORT statement for the reporting of cluster r and omised trials . Here we present up date d guidance , based on the 2001 revision of the CONSORT statement Under the Medicare diagnosis-related group ( DRG ) based inpatient prospect i ve payment system ( IPPS ) , payments to hospitals can increase when a post-admission complication occurs . This article proposes a re design of IPPS that reduces , but does not eliminate , the increase in payment due to post-admission complications . Using California data that contained a specification of whether each diagnosis was present at admission , and applying a conservative approach to identifying potentially preventable complications , the impact of post-admission complications on DRG assignment was determined . Based on the re design ed IPPS , the increase in Medicare payments due to post-admission complications was reduced by more than one billion dollars annually Objective . Immunizations and other cost-effective preventive services remain underused by many children , especially those living in poverty . Given the effectiveness of provider-based tracking systems and the widespread use by managed care organizations of financial incentives to influence physician practice patterns , we design ed and tested an intervention combining these strategies . We studied whether a system of semiannual assessment and feedback , coupled with financial incentives , could improve pediatric preventive care in a Medicaid health maintenance organization ( HMO ) . Methodology . We r and omly assigned primary care sites serving children in a Medicaid HMO to one of three groups : a feedback group ( where physicians received written feedback about compliance scores ) , a feedback and incentive group ( where physicians received feedback and a financial bonus when compliance criteria were met ) , and a control group . We evaluated compliance with pediatric preventive care guidelines through semiannual chart audits during the years 1993 to 1995 . Results . Compliance with pediatric preventive care improved dramatically in the study period . Repeated measures ANOVA demonstrated a significant increase in all three study groups throughout the time in total compliance scores ( from 56%–73 % ) , as well as scores for immunizations ( from 62%–79 % ) and other preventive care ( from 54%–71 % ) . However , no significant differences were observed between either intervention group and the control group , nor were there any interaction ( group-by-time ) effects . Conclusions . Feedback to physicians , with or without financial incentives , did not improve pediatric preventive care in this Medicaid HMO during a time of rapid , secular improvements in care . Possible explanations include the context and timing of the intervention , the magnitude of the financial incentives , and lack of physician awareness of the intervention Adequate reporting of r and omized , controlled trials ( RCTs ) is necessary to allow accurate critical appraisal of the validity and applicability of the results . The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement , a 22-item checklist and flow diagram , is intended to address this problem by improving the reporting of RCTs . However , some specific issues that apply to trials of nonpharmacologic treatments ( for example , surgery , technical interventions , devices , rehabilitation , psychotherapy , and behavioral intervention ) are not specifically addressed in the CONSORT Statement . Furthermore , considerable evidence suggests that the reporting of nonpharmacologic trials still needs improvement . Therefore , the CONSORT group developed an extension of the CONSORT Statement for trials assessing nonpharmacologic treatments . A consensus meeting of 33 experts was organized in Paris , France , in February 2006 , to develop an extension of the CONSORT Statement for trials of nonpharmacologic treatments . The participants extended 11 items from the CONSORT Statement , added 1 item , and developed a modified flow diagram . To allow adequate underst and ing and implementation of the CONSORT extension , the CONSORT group developed this elaboration and explanation document from a review of the literature to provide examples of adequate reporting . This extension , in conjunction with the main CONSORT Statement and other CONSORT extensions , should help to improve the reporting of RCTs performed in this field OBJECTIVE To examine the extent to which medical group and market factors are related to individual primary care physician ( PCP ) performance on patient experience measures . DATA SOURCES This study employs Clinician and Group CAHPS survey data ( n=105,663 ) from 2,099 adult PCPs belonging to 34 diverse medical groups across California . Medical group directors were interviewed to assess the magnitude and nature of financial incentives directed at individual physicians and the adoption of patient experience improvement strategies . Primary care services area ( PCSA ) data were used to characterize the market environment of physician practice s. STUDY DESIGN We used multilevel models to estimate the relationship between medical group and market factors and physician performance on each Clinician and Group CAHPS measure . Models statistically controlled for respondent characteristics and accounted for the clustering of respondents within physicians , physicians within medical groups , and medical groups within PCSAs using r and om effects . PRINCIPAL FINDINGS Compared with physicians belonging to independent practice associations , physicians belonging to integrated medical groups had better performance on the communication ( p=.007 ) and care coordination ( p=.03 ) measures . Physicians belonging to medical groups with greater numbers of PCPs had better performance on all measures . The use of patient experience improvement strategies was not associated with performance . Greater emphasis on productivity and efficiency criteria in individual physician financial incentive formulae was associated with worse access to care ( p=.04 ) . Physicians located in PCSAs with higher area-level deprivation had worse performance on the access to care ( p=.04 ) and care coordination ( p<.001 ) measures . CONCLUSIONS Physicians from integrated medical groups and groups with greater numbers of PCPs performed better on several patient experience measures , suggesting that organized care processes adopted by these groups may enhance patients ' experiences . Physicians practicing in markets with high concentrations of vulnerable population s may be disadvantaged by constraints that affect performance . Future studies should clarify the extent to which performance deficits associated with area-level deprivation are modifiable OBJECTIVES Mathematical modeling is used widely in economic evaluations of pharmaceuticals and other health-care technologies . Users of models in government and the private sector need to be able to evaluate the quality of models according to scientific criteria of good practice . This report describes the consensus of a task force convened to provide modelers with guidelines for conducting and reporting modeling studies . METHODS The task force was appointed with the advice and consent of the Board of Directors of ISPOR . Members were experienced developers or users of models , worked in academia and industry , and came from several countries in North America and Europe . The task force met on three occasions , conducted frequent correspondence and exchanges of drafts by electronic mail , and solicited comments on three drafts from a core group of external review ers and more broadly from the membership of ISPOR . RESULTS Criteria for assessing the quality of models fell into three areas : model structure , data used as inputs to models , and model validation . Several major themes cut across these areas . Models and their results should be represented as aids to decision making , not as statements of scientific fact ; therefore , it is inappropriate to dem and that models be vali date d prospect ively before use . However , model assumptions regarding causal structure and parameter estimates should be continually assessed against data , and models should be revised accordingly . Structural assumptions and parameter estimates should be reported clearly and explicitly , and opportunities for users to appreciate the conditional relationship between inputs and outputs should be provided through sensitivity analyses . CONCLUSIONS Model-based evaluations are a valuable re source for health-care decision makers . It is the responsibility of model developers to conduct modeling studies according to the best practicable st and ards of quality and to communicate results with adequate disclosure of assumptions and with the caveat that conclusions are conditional upon the assumptions and data on which the model is built BACKGROUND Evidence from cost-effective smoking cessation programs is scarce . This study determined the cost-effectiveness of 3 smoking cessation strategies as provided by general practitioners ( GPs ) in Germany . METHODS In a cluster-r and omized smoking cessation trial , rates and intervention costs for 577 smoking patients of 82 GPs were followed up for 12 months . Three smoking cessation treatments were tested : ( 1 ) GP training plus GP remuneration for each abstinent patient , ( 2 ) GP training plus cost-free nicotine replacement medication and /or bupropion hydrochloride for the patient , and ( 3 ) a combination of both strategies . Smoking abstinence at 12 months was the primary outcome used to calculate incremental cost-effectiveness ratios and net monetary benefits . RESULTS Intervention 1 was not effective compared with treatment as usual ( TAU ) . Interventions 2 and 3 each proved to be cost-effective compared separately with TAU . When applying a 95 % level of certainty of cost-effectiveness against TAU , euro 9.80 or euro 6.96 , respectively , had to be paid for each additional 1 % of patients abstinent at 12 months ( maximum willingness to pay ) . That means that in intervention 2 , euro 92.12 per patient in the program must be invested to gain 1 additional quitter ( as opposed to euro 39.10 paid per patient during the trial ) . In intervention 2 , the cost was euro 82.82 , as opposed to euro 50.04 . Neither of these 2 cost-effective treatments proved to be superior to the other . The cost-effectiveness of both treatments was stable against TAU in sensitivity analyses . ( The exchange rate from October 1 , 2003 , was used ; euro1 = $ 1.17 . ) CONCLUSIONS Both treatments have a high potential to reduce smoking-related morbidity at a low cost . It is highly recommended that they be implemented as a routine service offered by GPs because in many countries , health insurance plans currently do not fund nicotine replacement therapy BACKGROUND Tobacco quitlines offer clinicians a means to connect their patients with evidence -based treatments . Innovative methods are needed to increase clinician referral . METHODS This is a clinic r and omized trial that compared usual care ( n = 25 clinics ) vs a pay-for-performance program ( intervention ) offering $ 5000 for 50 quitline referrals ( n = 24 clinics ) . Pay-for-performance clinics also received monthly up date s on their referral numbers . Patients were eligible for referral if they visited a participating clinic , were 18 years or older , currently smoked cigarettes , and intended to quit within the next 30 days . The primary outcome was the clinic 's rate of quitline referral ( ie , number of referrals vs number of smokers seen in clinic ) . RESULTS Pay-for-performance clinics referred 11.4 % of smokers ( 95 % confidence interval [ CI ] , 8.0%-14.9 % ; total referrals , 1483 ) compared with 4.2 % ( 95 % CI , 1.5%-6.9 % ; total referrals , 441 ) for usual care clinics ( P = .001 ) . Rates of referral were similar in intervention vs usual care clinics ( n = 9 ) with a history of being very engaged with quality improvement activities ( 14.1 % vs 15.1 % , respectively ; P = .85 ) . Rates were substantially higher in intervention vs usual care clinics with a history of being engaged ( n = 22 clinics ; 10.1 % vs 3.0 % ; P = .001 ) or less engaged ( n = 18 clinics ; 10.1 % vs 1.1 % ; P = .02 ) with quality improvement . The rate of patient contact after referral was 60.2 % ( 95 % CI , 49.7%-70.7 % ) . Among those contacted , 49.4 % ( 95 % CI , 42.8%-55.9 % ) enrolled , representing 27.0 % ( 95 % CI , 21.3%-32.8 % ) of all referrals . The marginal cost per additional quitline enrollee was $ 300 . CONCLUSION A pay-for-performance program increases referral to tobacco quitline services , particularly among clinics with a history of less engagement in quality improvement activities OBJECTIVE To determine the probable effect of the Vaccines for Children ( VFC ) program on immunization coverage . DESIGN Preintervention and postintervention study design , with data collected before and after enrollment in the VFC program . SETTING Twenty-three inner-city neighborhood physicians ' offices in New York City . PARTICIPANTS In 1993 , 30 physicians were r and omly selected from 8 neighborhoods with the highest proportions of Medicaid-eligible individuals in New York City . In 1995 - 1996 , the 30 physicians were contacted again . Twenty-three \n Output:\n " }, { "from": "agent", "value": "Results One hundred twenty-eight evaluation studies provide a large body of evidence -to be interpreted with caution - concerning the effects of P4P on clinical effectiveness and equity of care .\nHowever , less evidence on the impact on coordination , continuity , patient-centeredness and cost-effectiveness was found .\nP4P effects can be judged to be encouraging or disappointing , depending on the primary mission of the P4P program : supporting minimal quality st and ards and /or boosting quality improvement .\nMoreover , the effects of P4P interventions varied according to design choices and characteristics of the context in which it was introduced .\nConclusions P4P programs result in the full spectrum of possible effects for specific targets , from absent or negligible to strongly beneficial ." } ]

[ { "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 Cognitive deficits are stable features of schizophrenia that are linked to functional outcome . Cognitive remediation approaches have been proven successful in ameliorating these deficits , although effect sizes vary considerably . Whether cognitive deficits are serious predictors of clinical outcome is less clear . Methods Sixty patients suffering from schizophrenia were included in our sample , thirty of them received computer-assisted cognitive training , and thirty received occupational therapy . For a sub sample of 55 patients , who could be traced over a period of five years after the end of the cognitive remediation intervention , time until first relapse and time in psychosis were determined retrospectively from their medical records . Results Cognitive remediation significantly improved problem solving , memory and attention with high effect sizes . Employment status , a post test verbal memory performance measure and a measure of executive functioning outperformed all other measures in the prediction of time to relapse , while allocation to treatment group outperformed all other variables in the prediction of both cognitive measures . Conclusions Cognitive remediation of neurocognitive deficits thus makes sense in a twofold fashion : It enhances cognition directly and positively acts on clinical course indirectly via improved neurocognition . Trial registration German Clinical Trials Register : This study examined the benefits of adding game elements to st and ard computerized working memory ( WM ) training . Specifically , it examined whether game elements would enhance motivation and training performance of children with ADHD , and whether it would improve training efficacy . A total of 51 children with ADHD aged between 7 and 12 years were r and omly assigned to WM training in a gaming format or to regular WM training that was not in a gaming format . Both groups completed three weekly sessions of WM training . Children using the game version of the WM training showed greater motivation ( i.e. , more time training ) , better training performance ( i.e. , more sequences reproduced and fewer errors ) , and better WM ( i.e. , higher scores on a WM task ) at post-training than children using the regular WM training . Results are discussed in terms of executive functions and reinforcement models of ADHD . It is concluded that WM training with game elements significantly improves the motivation , training performance , and working memory of children with ADHD . The findings of this study are encouraging and may have wide-reaching practical implication s in terms of the role of game elements in the design and implementation of new intervention efforts for children with ADHD Cognitive control is defined by a set of neural processes that allow us to interact with our complex environment in a goal -directed manner . Humans regularly challenge these control processes when attempting to simultaneously accomplish multiple goals ( multitasking ) , generating interference as the result of fundamental information processing limitations . It is clear that multitasking behaviour has become ubiquitous in today ’s technologically dense world , and substantial evidence has accrued regarding multitasking difficulties and cognitive control deficits in our ageing population . Here we show that multitasking performance , as assessed with a custom- design ed three-dimensional video game ( NeuroRacer ) , exhibits a linear age-related decline from 20 to 79 years of age . By playing an adaptive version of NeuroRacer in multitasking training mode , older adults ( 60 to 85 years old ) reduced multitasking costs compared to both an active control group and a no-contact control group , attaining levels beyond those achieved by untrained 20-year-old participants , with gains persisting for 6 months . Furthermore , age-related deficits in neural signatures of cognitive control , as measured with electroencephalography , were remediated by multitasking training ( enhanced midline frontal theta power and frontal – posterior theta coherence ) . Critically , this training result ed in performance benefits that extended to untrained cognitive control abilities ( enhanced sustained attention and working memory ) , with an increase in midline frontal theta power predicting the training-induced boost in sustained attention and preservation of multitasking improvement 6 months later . These findings highlight the robust plasticity of the prefrontal cognitive control system in the ageing brain , and provide the first evidence , to our knowledge , of how a custom- design ed video game can be used to assess cognitive abilities across the lifespan , evaluate underlying neural mechanisms , and serve as a powerful tool for cognitive enhancement BACKGROUND People with autism spectrum disorders ( ASDs ) experience executive function ( EF ) deficits . There is an urgent need for effective interventions , but in spite of the increasing research focus on computerized cognitive training , this has not been studied in ASD . Hence , we investigated two EF training conditions in children with ASD . METHODS In a r and omized controlled trial , children with ASD ( n = 121 , 8 - 12 years , IQ > 80 ) were r and omly assigned to an adaptive working memory ( WM ) training , an adaptive cognitive flexibility-training , or a non-adaptive control training ( mock-training ) . Braingame Brian , a computerized EF-training with game-elements , was used . Outcome measures ( pretraining , post-training , and 6-week-follow-up ) were near-transfer to trained EFs , far-transfer to other EFs ( sustained attention and inhibition ) , and parent 's ratings of daily life EFs , social behavior , attention deficit hyperactivity disorder (ADHD)-behavior , and quality of life . RESULTS Attrition-rate was 26 % . Children in all conditions who completed the training improved in WM , cognitive flexibility , attention , and on parent 's ratings , but not in inhibition . There were no significant differential intervention effects , although children in the WM condition showed a trend toward improvement on near-transfer WM and ADHD-behavior , and children in the cognitive flexibility condition showed a trend toward improvement on near-transfer flexibility . CONCLUSION Although children in the WM condition tended to improve more in WM and ADHD-behavior , the lack of differential improvement on most outcome measures , the absence of a clear effect of the adaptive training compared to the mock-training , and the high attrition rate suggest that the training in its present form is probably not suitable for children with ASD Patients with amnestic mild cognitive impairment are at high risk for developing Alzheimer 's disease . Besides episodic memory dysfunction they show deficits in accessing context ual knowledge that further specifies a general spatial navigation task or an executive function ( EF ) virtual action planning . Virtual reality ( VR ) environments have already been successfully used in cognitive rehabilitation and show increased potential for use in neuropsychological evaluation allowing for greater ecological validity while being more engaging and user friendly . In our study we employed the in-house platform of virtual action planning museum ( VAP-M ) and a sample of 25 MCI and 25 controls , in order to investigate deficits in spatial navigation , prospect i ve memory , and executive function . In addition , we used the morphology of late components in event-related potential ( ERP ) responses , as a marker for cognitive dysfunction . The related measurements were fed to a common classification scheme facilitating the direct comparison of both approaches . Our results indicate that both the VAP-M and ERP averages were able to differentiate between healthy elders and patients with amnestic mild cognitive impairment and agree with the findings of the virtual action planning supermarket ( VAP-S ) . The sensitivity ( specificity ) was 100 % ( 98 % ) for the VAP-M data and 87 % ( 90 % ) for the ERP responses . Considering that ERPs have proven to advance the early detection and diagnosis of \" presymptomatic AD , \" the suggested VAP-M platform appears as an appealing alternative Cognitive decline in aging is a pressing issue associated with significant healthcare costs and deterioration in quality of life . Previously , we reported the successful use of a novel brain-computer interface ( BCI ) training system in improving symptoms of attention deficit hyperactivity disorder . Here , we examine the feasibility of the BCI system with a new game that incorporates memory training in improving memory and attention in a pilot sample of healthy elderly . This study investigates the safety , usability and acceptability of our BCI system to elderly , and obtains an efficacy estimate to warrant a phase III trial . Thirty-one healthy elderly were r and omized into intervention ( n = 15 ) and waitlist control arms ( n = 16 ) . Intervention consisted of an 8-week training comprising 24 half-hour sessions . A usability and acceptability question naire was administered at the end of training . Safety was investigated by querying users about adverse events after every session . Efficacy of the system was measured by the change of total score from the Repeatable Battery for the Assessment of Neuropsychological Status ( RBANS ) before and after training . Feedback on the usability and acceptability question naire was positive . No adverse events were reported for all participants across all sessions . Though the median difference in the RBANS change scores between arms was not statistically significant , an effect size of 0.6SD was obtained , which reflects potential clinical utility according to Simon ’s r and omized phase II trial design . Pooled data from both arms also showed that the median change in total scores pre and post-training was statistically significant ( Mdn = 4.0 ; p<0.001 ) . Specifically , there were significant improvements in immediate memory ( p = 0.038 ) , visuospatial/constructional ( p = 0.014 ) , attention ( p = 0.039 ) , and delayed memory ( p<0.001 ) scores . Our BCI-based system shows promise in improving memory and attention in healthy elderly , and appears to be safe , user-friendly and acceptable to senior users . Given the efficacy signal , a phase III trial is warranted . Trial Registration Clinical Trials.gov Although st and ard psychological treatments have been successful in treating several core features in eating disorders ( ED ) , other characteristics such as emotional regulation or impulsivity appear to be more resistant to change . There is a growing body of evidence to support the efficacy of cognitive remediation for cognitive and emotional difficulties in ED . Playmancer/ Isl and s is a video game ( VG ) design ed to specifically treat mental disorders , characterized by problems in impulse control . The objective of the game is to increase self-control over emotions , decision making and behaviours . The aim of this study is to describe the results from a consecutive series of nine bulimia nervosa patients who were treated with the VG in addition to cognitive behaviour therapy ( CBT ) . The outcomes included clinical and psychopathological question naires , and physiological measures were obtained during the VG . Emotional regulation improved , heart rate variability increased , and respiratory rate and impulsivity measures reduced after the treatment . These findings suggest that VG training may enhance treatment for ED Introduction Executive functions ( EFs ) training interventions aim ed at ADHD-symptom reduction have yielded mixed results . Generally , these interventions focus on training a single cognitive domain ( e.g. , working memory [ WM ] , inhibition , or cognitive-flexibility ) . However , evidence suggests that most children with ADHD show deficits on multiple EFs , and that these EFs are largely related to different brain regions . Therefore , training multiple EFs might be a potentially more effective strategy to reduce EF-related ADHD symptoms . Methods Eighty-nine children with a clinical diagnosis of ADHD ( aged 8–12 ) were r and omized to either a full-active-condition where visuospatial WM , inhibition and cognitive-flexibility were trained , a partially-active-condition where inhibition and cognitive-flexibility were trained and the WM-training task was presented in placebo-mode , or to a full placebo-condition . Short-term and long-term ( 3-months ) effects of this gamified , 25-session , home-based computer-training were evaluated on multiple outcome domains . Results During training compliance was high ( only 3 % failed to meet compliance criteria ) . After training , only children in the full-active condition showed improvement on measures of visuospatial short-term-memory ( STM ) and WM . Inhibitory performance and interference control only improved in the full-active- and the partially-active condition . No Treatment-condition x Time interactions were found for cognitive-flexibility , verbal WM , complex-reasoning , nor for any parent- , teacher- , or child-rated ADHD behaviors , EF-behaviors , motivational behaviors , or general problem behaviors . Nonetheless , almost all measures showed main Time-effects , including the teacher-ratings . Conclusions Improvements on inhibition and visuospatial STM and WM were specifically related to the type of treatment received . However , transfer to untrained EFs and behaviors was mostly nonspecific ( i.e. , only interference control improved exclusively in the two EF training conditions ) . As such , in this multiple EF-training , mainly nonspecific treatment factors – as opposed to the specific effects of training EFs — seem related to far transfer effects found on EF and behavior . Trial Registration trialregister.nl NTR2728 . Registry name : improving executive functioning in children with ADHD : training executive functions within the context of a computer game ; registry number : NTR2728 Impaired executive function and impulsiveness or intolerance to boredom in adult attention deficit/hyperactivity disorder ( ADHD ) are thought to compromise performance at work . Several task parameters help people with ADHD to perform better on computerized cognitive tasks , namely reduced response-to-stimulus interval , discriminative feedback , or a format resembling a videogame . However , still very little is known about how these context s might be helpful in a real work environment . We developed a computerized task resembling a fast-paced videogame with no response-to-stimulus interval and constant and diverse discriminative error feedback . The task included several measurements of high-order executive function ( planning , working memory , and prospect i ve memory ) formatted as a single multitask simulating occupational activities ( SOA ) . We also administered the Continuous Performance Test-II ( CPT-II ) , a very simple vigilance task without discriminative feedback and with long response-to-stimulus intervals . We tested 30 adults answering to DSM-IV criteria of ADHD ( combined type ) and 30 IQ-matched adults without ADHD . As has been reported many times , the ADHD participants made significantly more errors of commission than the control participants on the CPT-II , whereas the two groups made the same number of errors of commission on the SOA . The ADHD group also sought discriminative feedback significantly more \n Output:\n " }, { "from": "agent", "value": "We found that working memory and general executive functions were common targets for both gamified assessment and training .\nGamified tests were typically vali date d successfully , although mixed-domain measurement was a problem .\nGamified training appears to be highly engaging and does boost participant motivation , but mixed effects of gamification on task performance were 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: Background Coffee consumption has been associated with a lower risk of type 2 diabetes in prospect i ve cohort studies , but the underlying mechanisms remain unclear . The aim of this study was to evaluate the effects of regular and decaffeinated coffee on biological risk factors for type 2 diabetes . Methods R and omized parallel-arm intervention conducted in 45 healthy overweight volunteers who were nonsmokers and regular coffee consumers . Participants were assigned to consumption of 5 cups ( 177 mL each ) per day of instant caffeinated coffee , decaffeinated coffee , or no coffee ( i.e. , water ) for 8 weeks . Results Average age was 40 years and body mass index was 29.5 kg/m2 . Compared with consuming no coffee , consumption of caffeinated coffee increased adiponectin ( difference in change from baseline 1.4 μg/mL ; 95 % CI : 0.2 , 2.7 ) and interleukin-6 ( difference : 60 % ; 95 % CI : 8 , 138 ) concentrations and consumption of decaffeinated coffee decreased fetuin-A concentrations ( difference : -20 % ; 95 % CI : -35 , -1 ) . For measures of glucose tolerance , insulin sensitivity , and insulin secretion , no significant differences were found between treatment groups . Conclusions Although no changes in glycemia and /or insulin sensitivity were observed after 8 weeks of coffee consumption , improvements in adipocyte and liver function as indicated by changes in adiponectin and fetuin-A concentrations may contribute to beneficial metabolic effects of long-term coffee consumption . Trial Registration clinical trials.gov BACKGROUND Early studies suggested that coffee consumption may increase the risk of chronic disease . OBJECTIVE We investigated prospect ively the association between coffee consumption and the risk of chronic diseases , including type 2 diabetes ( T2D ) , myocardial infa rct ion ( MI ) , stroke , and cancer . DESIGN We used data from 42,659 participants in the European Prospect i ve Investigation into Cancer and Nutrition (EPIC)-Germany study . Coffee consumption was assessed by self-administered food-frequency question naire at baseline , and data on medically verified incident chronic diseases were collected by active and passive follow-up procedures . HRs and 95 % CIs were calculated with multivariate Cox regression models and compared by competing risk analysis . RESULTS During 8.9 y of follow-up , we observed 1432 cases of T2D , 394 of MI , 310 of stroke , and 1801 of cancer as first qualifying events . Caffeinated ( HR : 0.94 ; 95 % CI : 0.84 , 1.05 ) or decaffeinated ( HR : 1.05 ; 95 % CI : 0.84 , 1.31 ) coffee consumption ( ≥4 cups/d compared with < 1 cup/d ; 1 cup was defined as 150 mL ) was not associated with the overall risk of chronic disease . A lower risk of T2D was associated with caffeinated ( HR : 0.77 ; 95 % CI : 0.63 , 0.94 ; P-trend 0.009 ) and decaffeinated ( HR : 0.70 ; 95 % CI : 0.46 , 1.06 ; P-trend : 0.043 ) coffee consumption ( ≥4 cups/d compared with < 1 cup/d ) , but cardiovascular disease and cancer risk were not . The competing risk analysis showed no significant differences between the risk associations of individual diseases . CONCLUSION Our findings suggest that coffee consumption does not increase the risk of chronic disease , but it may be linked to a lower risk of T2D Caffeine increases blood pressure ( BP ) . In men , acute BP elevations after caffeine intake are due to an increase in vascular resistance , with no change in cardiac output . The hemodynamic effects of caffeine have not been studied in women . Accordingly , BP and hemodynamic responses to caffeine were measured in a double-blind trial comparing age-matched men and women at rest and during mental stress . Caffeine ( 3.3 mg/kg , equivalent to 2 to 3 cups of brewed coffee ) or placebo was given to separate groups of women ( n = 21 and 21 ) and men ( n = 16 and 19 ) ( mean ages 29 and 27 years , respectively ) . BP , cardiac output , and vascular resistance were observed at rest , during a stressful public-speaking simulation , reading aloud , and recovery . Caffeine caused nearly identical systolic and diastolic BP elevations in women ( 4.5 and 3.3 mm Hg , respectively ) and men ( 4.1 and 3.8 mm Hg , respectively ) . Men given caffeine versus placebo showed the expected elevation in vascular resistance throughout the remainder of the protocol ( p < 0.001 ) , with no difference in cardiac output . In contrast , women responded to caffeine with increases in stroke volume ( p < 0.001 ) and cardiac output ( p < 0.001 ) , with no difference in vascular resistance from women taking placebo . Men and women have similar BP responses to caffeine , but the BP responses may arise from different hemodynamic mechanisms . Women who consume a dietary dose of caffeine showed an increase in cardiac output , whereas men showed increased vascular resistance Context Previous studies have examined the association between coffee consumption and a variety of specific diseases , such as type 2 diabetes , different types of cancer , and cardiovascular disease . However , the relationship between coffee consumption and all-cause mortality remains unclear . Contribution This study followed 2 large cohorts of men and women who provided data on coffee consumption , other behaviors , and health outcomes every 2 to 4 years over 2 decades . High coffee consumption was not related to increased mortality and may even be associated with lower total and cardiovascular mortality . Caution Misclassification of coffee consumption or confounding by other behavioral factors may account for these observations . The Editors Several epidemiologic studies have examined coffee consumption and risk for coronary heart disease and other chronic diseases , but data on coffee consumption in relation to all-cause and disease-specific mortality are sparse . Some studies found that those who drank coffee were the healthiest cohort members ( 15 ) , an inverse association that has been attributed to a possible confounding effect by morbidity . However , it has recently been suggested that the inverse association between coffee and all-cause mortality is attributable to the beneficial effect of coffee consumption on inflammation ( 6 ) . The Appendix Table lists the previous studies that have examined coffee consumption and the risk for mortality by different causes . Appendix Table . Cohort Studies Addressing the Association between Coffee Consumption and All-Cause and Disease-Specific Mortality In support of this hypothesis , we found in a previous study an inverse association between coffee consumption and several markers of inflammation and endothelial dysfunction ( 7 ) . In addition , in the NHS ( Nurses ' Health Study ) and HPFS ( Health Professionals Follow-up Study ) , consumption of 6 or more cups of coffee per day was associated with a slightly lower risk for fatal coronary heart disease versus nonconsumers in both men and women ( 8) . Moreover , epidemiologic studies have consistently found an association between higher coffee consumption and lower risk for type 2 diabetes ( 9 ) . Finally , several studies have suggested that coffee might decrease the risk for some types of cancer , such as liver , colon , oral , pharyngeal , and esophageal ( 1012 ) . The objective of this study was to assess the association of coffee consumption with all-cause , cardiovascular disease ( CVD ) , and cancer mortality . The long follow-up and the use of repeated dietary measurements allowed us to assess long-term coffee consumption . In addition , information about incident diseases during the follow-up and up date d measurements of main risk factors for CVD and cancer allowed us to control for potential confounders in detail . Methods Study Population The HPFS was established in 1986 and the NHS in 1976 . Information ( excluding diet ) on the cohort members has been up date d every 2 years . Further details have been published elsewhere ( 13 ) . We used 1980 as baseline for the NHS because this was the first year in which dietary information was collected in this cohort . After excluding participants with CVD or cancer at baseline or those with no information about coffee consumption at baseline ( 1183 persons in the HPFS and 879 in the NHS ) , we included 41736 men and 86214 women who were followed until 2004 . The Harvard School of Public Health and Brigham and Women 's Hospital Human Subjects Committee Review Board approved the study protocol . Assessment of Coffee Consumption Dietary question naires were sent to the HPFS participants in 1986 , 1990 , 1994 , and 1998 and to the NHS participants in 1980 , 1984 , 1986 , 1990 , 1994 , and 1998 . In each question naire , participants were asked how often on average during the previous year they had consumed coffee and tea . The participants could choose from 9 responses . Decaffeinated coffee and different types of caffeinated soft drinks were first assessed in 1986 in the HPFS and in 1984 in the NHS . We also inquired at baseline about whether the participant 's consumption for each beverage had greatly increased or decreased during the preceding 10 years . Using the U.S. Department of Agriculture food composition sources supplemented with other sources , we estimated that the caffeine content was 137 mg per cup of coffee , 47 mg per cup of tea , 46 mg per can or 12-ounce bottle of a soft drink , and 7 mg per 1-ounce serving of chocolate c and y. We assessed the total intake of caffeine by summing the caffeine content for a unit of each food during the previous year multiplied by a weight proportional to the frequency of its consumption . In our validation study , we obtained high correlations between consumption of coffee and other caffeinated beverages estimated from the food frequency question naire and consumption estimated from repeated 1-week diet records ( coffee , r= 0.78 ; tea , r= 0.93 ; and caffeinated soft drinks , r= 0.85 ) ( 14 ) . Ascertainment of Mortality Deaths were reported by the next of kin or the postal authorities or were ascertained through the National Death Index . We estimated that follow-up for deaths was more than 98 % complete ( 15 ) . For all deaths , we sought death certificates and , when appropriate , requested permission from the next of kin to review medical records . The underlying cause of death was assigned according to the International Classification of Diseases , Eighth Revision ( ICD-8 ) . The primary end point in this analysis was death from any cause . We also conducted analyses according to the main causes of deaths in the cohorts , which were CVD ( ICD-8 codes 390.0 through 458.9 and 795.0 to 795.9 ) and cancer ( ICD-8 codes 140.0 through 207.9 ) , and according to secondary causes of death , such as chronic liver disease and cirrhosis ( ICD-8 code 571.0 ) , chronic obstructive pulmonary disease ( ICD-8 codes 492.0 , 496.0 , and 519.0 ) , diabetes ( ICD-8 codes 250.0 , 250.1 , and 250.9 ) , neurodegenerative diseases ( ICD-8 codes 331.0 and 332.0 ) , and sudden death ( ICD-8 code 798.0 ) . Assessment of Medical History , Anthropometric Data , and Lifestyle Factors In the baseline question naires , we requested information about age ; weight and height ; smoking status ; parental history with respect to myocardial infa rct ion ; menopausal status and use of hormone therapy in women ; and history of hypertension , hypercholesterolemia , and type 2 diabetes mellitus . We up date d this information , with the exception of height and parental history , in the biennial follow-up question naires . We assessed perceived health in 2000 by asking the participants to describe their health as excellent , very good , good , fair , or poor . We calculated body mass index , and we also assessed physical activity biennially . In the HPFS , participants were queried about the average time spent per week during the preceding year in specific activities ( for example , walking outdoors , jogging , and bicycling ) ( 16 ) . The time spent in each activity in hours per week was multiplied by its typical energy expenditure , expressed in metabolic equivalent tasks and then summed over all activities to yield a metabolic equivalent task or hour score . In the NHS , physical activity was reported in hours per week of moderate ( for example , brisk walking ) and vigorous exercise ( for example , strenuous sports and jogging ) ( 17 ) . St and ard portion sizes for alcoholic drinks were specified as a can , bottle , or glass for beer ; 4-oz glass for wine ; and 1 drink or shot for liquor . Detailed information on the validity and reproducibility of the information from the question naires about self-reported weight , physical activity , and alcohol consumption has been reported elsewhere ( 1820 ) . Statistical Analysis We classified participants according to levels of coffee consumption . We calculated person-years of exposure from the date of return of the baseline question naire to the date of death or 1 June 2004 , whichever came first . To reduce within-participant variation and best represent long-term diet , we used the cumulative average of coffee consumption from all available di \n Output:\n " }, { "from": "agent", "value": "This observation might reflect the long-term effects of coffee manifested in habitual drinkers who developed tolerance to the acute effects of caffeine .\nFor example , phenolic compounds in coffee ( chlorogenic acid , ferulic acid , p-coumaric acid ) , magnesium , trigonelline , and quinides have been associated with improved insulin sensitivity ( 4 ) .\nPhenolic compounds also have antioxidant activity ( 5 ) .\nIn addition , diterpenes in coffee ( cafestol and kahweol ) have anticarcinogenic properties ( 6 ) .\nThus , it is plausible that the harmful effects of caffeine could be offset by the beneficial effects of these other components .\nThe results showed that neither caffeinated nor decaffeinated coffee consumption was associated with an increased risk of total chronic disease , CVD , or cancer ; furthermore , both types of coffee showed an inverse association with the risk of type 2 diabetes .\nThis indicates that coffee improves adipocyte and liver function , which may decrease the risk of type 2 diabetes .\nThe work by Floegel et al ( 7 ) adds to the evidence on the null association between habitual coffee consumption and CVD , cancer , and total mortality , another indicator of the global effect on health ( 11 ) , and suggests that this beverage may produce health benefits .\nIn short-term studies , nonfiltered coffee has been shown to" } ]

[ { "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 — Mechanical thrombectomy has the potential to improve recanalization rates and outcomes for patients with ischemic stroke , but potential gains could be offset by procedural complications and costs . We evaluated the cost and utility of combined intravenous ( IV ) tissue-type plasminogen activator ( tPA ) and mechanical thrombectomy compared to IV tPA alone for acute large-vessel ischemic stroke . Methods — We constructed a decision tree for a hypothetical 68-year-old with a large-vessel ischemic stroke who is eligible for IV tPA . The interventional strategy was IV tPA , a cerebral angiogram , and mechanical thrombectomy and thrombolysis if indicated . Recanalization , hemorrhage complications , and outcomes for the interventional strategy were from the Multi-MERCI study . The medical strategy was IV tPA using inputs from a comprehensive systematic review . Costs were estimated from Medicare reimbursements . We modeled lifetime costs and utilities for disability using a Markov model and Monte-Carlo multivariable sensitivity analysis . Results — For the baseline scenario , the recanalization rate was 72.9 % for the interventional strategy and 46.2 % for the medical strategy . For the interventional strategy , the symptomatic hemorrhage rate was 8.6 % with recanalization and 15.4 % without . For the medical strategy , the corresponding rates were 3.6 % and 13.3 % , respectively . The interventional strategy was cost-effective in 97.6 % of simulations ( incremental cost-effectiveness ratio $ 16 001/ quality -adjusted life year ; 95 % CI , $ 2736–$39 232 ) . Conclusions — Based on observational data , the combination of IV tPA and mechanical thrombectomy for large-vessel ischemic stroke appears to be cost-effective compared to IV tPA alone . These findings require additional validation with r and omized trial data Background and Purpose — Clinical trials have demonstrated improved 90-day outcomes for patients with acute ischemic stroke treated with stent retriever thrombectomy plus tissue-type plasminogen activator ( SST+tPA ) compared with tPA . Previous studies suggested that this strategy may be cost-effective , but models were derived from pooled data and older assumptions . Methods — In this prospect i ve economic sub study conducted alongside the SWIFT-PRIME trial ( Solitaire With the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke ) , in-trial costs were measured for patients using detailed medical re source utilization and hospital billing data . Utility weights were assessed at 30 and 90 days using the EuroQol-5 dimension question naire . Post-trial costs and life-expectancy were estimated for each surviving patient using a model based on trial data and inputs derived from a contemporary cohort of ischemic stroke survivors . Results — Index hospitalization costs were $ 17 183 per patient higher for SST+tPA than for tPA ( $ 45 761 versus $ 28 578 ; P<0.001 ) , driven by initial procedure costs . Between discharge and 90 days , costs were $ 4904 per patient lower for SST+tPA than for tPA ( $ 11 270 versus $ 16 174 ; P=0.014 ) ; total 90-day costs remained higher with SST+tPA ( $ 57 031 versus $ 44 752 ; P<0.001 ) . Higher utility values for SST+tPA led to higher in-trial quality -adjusted life years ( 0.131 versus 0.105 ; P=0.005 ) . In lifetime projections , SST+tPA was associated with substantial gains in quality -adjusted life years ( 6.79 versus 5.05 ) , cost savings of $ 23 203 per patient and was economically dominant when compared with tPA in 90 % of bootstrap replicates . Conclusions — Among patients with acute ischemic stroke enrolled in the SWIFT-PRIME trial , SST increased initial treatment costs , but was projected to improve quality -adjusted life-expectancy and reduce healthcare costs over a lifetime horizon compared with tPA . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT01657461 Objective : To evaluate the cost-effectiveness of adding endovascular thrombectomy to st and ard care in patients with acute ischemic stroke . Methods : The cost-effectiveness analysis of endovascular thrombectomy in patients with acute ischemic stroke was based on a decision-analytic Markov model . Primary outcomes from ESCAPE , Extending the Time for Thrombolysis in Emergency Neurological Deficits – Intra-Arterial ( EXTEND-IA ) , Multicenter R and omized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherl and s ( MR CLEAN ) , Endovascular Revascularization With Solitaire Device Versus Best Medical Therapy in Anterior Circulation Stroke Within 8 Hours ( REVASCAT ) , and Solitaire with the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke ( SWIFT PRIME ) along with data from published studies and registries were used in this analysis . We used a health care payer perspective and a lifelong time horizon to estimate costs and effects . Results : The model showed that adding thrombectomy with stent retrievers to guideline -based care ( including IV thrombolysis ) result ed in a gain of 0.40 life-years and 0.99 quality -adjusted life-years along with a cost savings of approximately $ 221 per patient . The sensitivity analysis showed that the results were not sensitive to changes in uncertain parameters or assumptions . Conclusions : Adding endovascular treatment to st and ard care result ed in substantial clinical benefits at low costs . The results were consistent throughout irrespective of whether data from ESCAPE , EXTEND-IA , MR CLEAN , REVASCAT , or SWIFT PRIME were used in this model OBJECT Mechanical thrombectomy is increasingly being used for the treatment of large-vessel ischemic stroke in patients who arrive outside of the 3-hour tissue plasminogen activator time window . In this study , the authors evaluated the cost and effectiveness of mechanical thrombectomy compared with st and ard medical therapy in patients who are ineligible to receive tissue plasminogen activator . METHODS Clinical outcomes of an open-label study of mechanical thrombectomy were compared with a hypothetical control group with a lower recanalization rate ( 18 vs 60 % ) and a lower rate of symptomatic intracranial hemorrhage ( 0.6 vs 7.8 % ) than the active treatment group . A Markov cost-effectiveness model was built to compare the health benefits and costs associated with mechanical thrombectomy compared with st and ard medical therapy . All probabilities , quality -of-life factors , and costs were estimated from the published literature . Univariate sensitivity analyses were performed to assess how variations in model parameters affect health and economic outcomes . RESULTS Treatment of acute ischemic stroke with mechanical thrombectomy increased survival time by 0.54 quality -adjusted life years ( QALYs ) , compared with st and ard medical therapy ( 2.37 vs 1.83 QALYs ) , at an increased cost of $ 6600 . This yielded an incremental cost-effectiveness ratio ( ICER ) of $ 12,120 per QALY gained , a value generally considered cost-effective . Sensitivity analysis showed that mechanical thrombectomy remained cost-effective ( ICER < $ 50,000 per QALY gained ) for all model inputs varied over a reasonable range , except for age at stroke treatment . For patients older than 82 years of age , the treatment was only borderline cost-effective ( ICER of $ 50,000 - 100,000 per QALY gained ) . CONCLUSIONS The treatment of large-vessel ischemic stroke with mechanical thrombectomy appears to be costeffective . These results require validation when data from a r and omized , controlled trial of mechanical thrombectomy become available Background and Purpose — The objective of this study was to determine the cost-effectiveness of intra-arterial treatment within the 0- to 6-hour window after intravenous tissue-type plasminogen activator within 0- to 4.5-hour compared with intravenous tissue-type plasminogen activator alone , in the US setting and from a social perspective . Methods — A decision analytic model estimated the lifetime costs and outcomes associated with the additional benefit of intra-arterial therapy compared with st and ard treatment with intravenous tissue-type plasminogen activator alone . Model inputs were obtained from published literature , the Multicenter R and omized Clinical Trial of Endovascular Therapy for Acute Ischemic Stroke in the Netherl and s ( MR CLEAN ) study , and cl aims data bases in the United States . Health outcomes were measured in quality -adjusted life years ( QALYs ) . Treatment benefit was assessed by calculating the cost per QALY gained . One-way and probabilistic sensitivity analyses were performed to estimate the overall uncertainty of model results . Results — The addition of intra-arterial therapy compared with st and ard treatment alone yielded a lifetime gain of 0.7 QALY for an additional cost of $ 9911 , which result ed in a cost of $ 14 137 per QALY . Multivariable sensitivity analysis predicted cost-effectiveness ( ⩽$50 000 per QALY ) in 97.6 % of simulation runs . Conclusions — Intra-arterial treatment after intravenous tissue-type plasminogen activator for patients with anterior circulation strokes within the 6-hour window is likely cost-effective . From a societal perspective , increased investment in access to intra-arterial treatment for acute stroke may be justified BACKGROUND AND PURPOSE : It is unclear whether the costs and risks of mechanical therapies make them cost-effective . We examined whether interventions such as mechanical clot removal or disruption with angioplasty are cost-effective for acute ischemic stroke compared with best medical therapy . MATERIAL S AND METHODS : We performed a cost-utility analysis of patients with acute stroke due to large intracranial artery occlusion presenting beyond the 3-hour window for IV tPA . Model inputs for the mechanical arm were derived from Multi MERCI trial data and a recent meta- analysis . For best medical therapy , we used rates of spontaneous recanalization , ICH , and functional outcomes based on a systematic literature review . Discounted QALYs were determined by using the Markov modeling for 65-year-old patients with acute ischemic stroke . RESULTS : On the basis of a systematic literature review , we modeled an 84 % rate of recanalization with mechanical intervention and a 6.3 % rate of symptomatic ICH . For best medical therapy , we modeled a spontaneous recanalization rate of 24 % with a 2 % rate of symptomatic ICH . Mechanical therapies were associated with a $ 7718 net cost and a gain of a 0.82 QALYs for each use , thus yielding a net of $ 9386/QALY gained . In sensitivity analyses , results were dependent on the rates of recanalization , symptomatic ICH rates , and costs of treatment . CONCLUSIONS : On the basis of available data , mechanical therapies in qualified patients with acute stroke beyond the window for IV tPA appear to be cost-effective . However , the inputs are not derived from r and omized trials , and results are sensitive to several assumptions BACKGROUND Thrombolytic therapy for acute ischemic stroke has been approached cautiously because there were high rates of intracerebral hemorrhage in early clinical trials . We performed a r and omized , double-blind trial of intravenous recombinant tissue plasminogen activator ( t-PA ) for ischemic stroke after recent pilot studies suggested that t-PA was beneficial when treatment was begun within three hours of the onset of stroke . METHODS The trial had two parts . Part 1 ( in which 291 patients were enrolled ) tested whether t-PA had clinical activity , as indicated by an improvement of 4 points over base-line values in the score of the National Institutes of Health stroke scale ( NIHSS ) or the resolution of the neurologic deficit within 24 hours of the onset of stroke . Part 2 ( in which 333 patients were enrolled ) used a global test statistic to assess clinical outcome at three months , according to scores on the Barthel index , modified Rankin scale , Glasgow outcome scale , and NIHSS : RESULTS In part 1 , there was no significant difference between the group given t-PA and that given placebo in the percentages of patients with neurologic improvement at 24 hours , although a benefit was observed for the t-PA group at three months for all four outcome measures . In part 2 , the long-term clinical benefit of t-PA predicted by the results of part 1 was confirmed ( global odds ratio for a favorable outcome , 1.7 ; 95 percent confidence interval , 1.2 to 2.6 ) . As compared with patients given placebo , patients treated with t-PA were at least 30 percent more likely to have minimal or no disability at three months on the assessment scales . Symptomatic intracerebral hemorrhage within 36 hours after the onset of stroke occurred in 6.4 percent of patients given t-PA but only 0.6 percent of patients given placebo ( P < 0.001 ) . Mortality at three months was 17 percent in the t-PA group and 21 percent in the placebo group ( P = 0.30 ) . CONCLUSIONS Despite an increased incidence of symptomatic intracerebral hemorrhage , treatment with intraven \n Output:\n " }, { "from": "agent", "value": "Conclusions If the outcomes of the trials underpinning the evidence of clinical effectiveness can be replicated , then mechanical thrombectomy is likely to be cost-effective by typical willingness-to-pay thresholds .\nThis finding holds under the assumption that no investment is required to develop stroke centres to the st and ard required to provide a safe emergency endovascular service and that additional expenditure on timely patient transport is not required" } ]

[ { "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 the effectiveness of neuromuscular training in reducing the rate of acute knee injury in adolescent female football players . Design Stratified cluster r and omised controlled trial with clubs as the unit of r and omisation . Setting 230 Swedish football clubs ( 121 in the intervention group , 109 in the control group ) were followed for one season ( 2009 , seven months ) . Participants 4564 players aged 12 - 17 years ( 2479 in the intervention group , 2085 in the control group ) completed the study . Intervention 15 minute neuromuscular warm-up programme ( targeting core stability , balance , and proper knee alignment ) to be carried out twice a week throughout the season . Main outcome measures The primary outcome was rate of anterior cruciate ligament injury ; secondary outcomes were rates of severe knee injury ( > 4 weeks ’ absence ) and any acute knee injury . Results Seven players ( 0.28 % ) in the intervention group , and 14 ( 0.67 % ) in the control group had an anterior cruciate ligament injury . By Cox regression analysis according to intention to treat , a 64 % reduction in the rate of anterior cruciate ligament injury was seen in the intervention group ( rate ratio 0.36 , 95 % confidence interval 0.15 to 0.85 ) . The absolute rate difference was −0.07 ( 95 % confidence interval −0.13 to 0.001 ) per 1000 playing hours in favour of the intervention group . No significant rate reductions were seen for secondary outcomes . Conclusions A neuromuscular warm-up programme significantly reduced the rate of anterior cruciate ligament injury in adolescent female football players . However , the absolute rate difference did not reach statistical significance , possibly owing to the small number of events . Trial registration Clinical trials NCT00894595 Background : Anterior knee pain ( AKP ) is the most common activity-related injury of the knee . The authors investigated the effect of an exercise intervention on the incidence of AKP in UK army recruits undergoing a 14-week physically arduous training program . Hypothesis : Modifying military training to include targeted preventative exercises may reduce the incidence of AKP in a young recruit population . Study Design : R and omized controlled trial ; Level of evidence , 1 . Methods : A single-blind cluster r and omized controlled trial was performed in 39 male and 11 female training groups ( median age : 19.7 years ; interquartile range , 17 - 25 ) undergoing phase 1 of army recruit training . Each group was r and omly assigned to either an intervention ( n = 759 ) or control ( n = 743 ) protocol . The intervention consisted of 4 strengthening and 4 stretching exercises completed during supervised physical training lessons ( 7 per week ) . The control group followed the existing training syllabus warm-up exercises . The primary outcome was a diagnosis of AKP during the 14-week training program . Results : Forty-six participants ( 3.1 % ; 95 % confidence interval [ CI ] , 2.3 - 4.1 ) were diagnosed with AKP . There were 36 ( 4.8 % ; 95%CI , 3.5 - 6.7 ) new cases of AKP in the control group and 10 ( 1.3 % ; 0.7 - 2.4 ) in the intervention group . There was a 75 % reduction in AKP risk in the intervention group ( unadjusted hazard ratio = 0.25 ; 95 % CI , 0.13 - 0.52 ; P < .001 ) . Three participants ( 0.4 % ) from the intervention group were discharged from the military for medical reasons compared to 25 ( 3.4 % ) in the control group . Conclusion : A simple set of lower limb stretching and strengthening exercises result ed in a substantial and safe reduction in the incidence of AKP in a young military population undertaking a physical conditioning program . Such exercises could also be beneficial for preventing this common injury among nonmilitary participants in recreational physical activity Abstract Zouita , S , Zouita , ABM , Kebsi , W , Dupont , G , Ben Abderrahman , A , Ben Salah , FZ , and Zouhal , H. Strength training reduces injury rate in elite young soccer players during one season . J Strength Cond Res 30(5 ) : 1295–1307 , 2016—The purpose of this study was to examine the effect of strength training on physical fitness parameters and injuries occurrence in young elite soccer players . Fifty-two elite young soccer players ( 13–14 years ) were divided on a r and omized order into experimental group ( EG , n = 26 ) and control group ( CG , n = 26 ) . For EG , 2 to 3 sessions of strength training ( 90 minutes ) were introduced weekly in their training program for 12 weeks ( 4 × 3 weeks separated by 1-week recovery ) . Sprint tests ( 10 - 20 - 30 m ) , T-test time , and jumping tests were measured at the start ( T0 ) , at the middle ( T1 ) , and at the end of the experiment period ( T2 ) . The injury rate was recorded by the medical and fitness training staff throughout the soccer season . Compared to CG , EG performed significantly better in sprint running and T-test time at T2 ( p < 0.01 ) . Similarly , the improvement amount for jumping tests was significantly greater ( p ⩽ 0.05 ) in EG than in CG . A total of 17 injuries were recorded over the soccer season . The rate was higher in CG ( 13 injuries ) than in training group ( 4 injuries ) . This study showed that strength training accurately and efficiently scheduled in youth soccer players , induced performance improvement , and reduced the rate of injuries BACKGROUND The risk of musculoskeletal injury with the introduction of moderate-to-vigorous exercise in sedentary adults is not well established . The purpose of this report is to examine the effect of a 12-month exercise intervention on musculoskeletal injury and bodily pain in predominately overweight , sedentary men ( n = 102 ) and women ( n = 100 ) , ages 40 to 75 years . METHODS Participants were r and omized to a moderate-to-vigorous aerobic exercise intervention ( EX ) ( 6 d/wk , 60 min/d , 60 % to 85 % max . heart rate ) or usual lifestyle control ( CON ) . Participants completed a self-report of musculoskeletal injury and body pain at baseline and 12-months . RESULTS The number of individuals reporting an injury ( CON ; 28 % vs. EX ; 28 % , P = .95 ) did not differ by group . The most commonly injured site was lower leg/ankle/foot . The most common causes of injury were sports/physical activity , home maintenance , or \" other . \" In the control group , bodily pain increased over the 12 months compared with the exercise group ( CON -7.9 , EX -1.4 , P = .05 ) . Baseline demographics and volume of exercise were not associated with injury risk . CONCLUSIONS Previously sedentary men and women r and omized to a 12-month aerobic exercise intervention with a goal of 360 min/wk reported the same number of injuries as those in the control group and less bodily pain Sometimes interventions in r and omized clinical trials are not allocated to individual patients , but rather to patients in groups . This is called cluster allocation , or cluster r and omization , and is particularly common in health services research . Similarly , in some types of observational studies , patients ( or observations ) are found in naturally occurring groups , such as neighborhoods . In either situation , observations within a cluster tend to be more alike than observations selected entirely at r and om . This violates the assumption of independence that is at the heart of common methods of statistical estimation and hypothesis testing . Failure to account for the dependence between individual observations and the cluster to which they belong can have profound implication s on the design and analysis of such studies . Their p-values will be too small , confidence intervals too narrow , and sample size estimates too small , sometimes to a dramatic degree . This problem is similar to that caused by the more familiar \" unit of analysis error \" seen when observations are repeated on the same subjects , but are treated as independent . The purpose of this paper is to provide an introduction to the problem of clustered data in clinical research . It provides guidance and examples of methods for analyzing clustered data and calculating sample sizes when planning studies . The article concludes with some general comments on statistical software for cluster data and principles for planning , analyzing , and presenting such studies STUDY DESIGN An explorative , 1-year prospect i ve cohort study . Objective To examine whether an association between a sudden change in weekly running distance and running-related injury varies according to injury type . BACKGROUND It is widely accepted that a sudden increase in running distance is strongly related to injury in runners . But the scientific knowledge supporting this assumption is limited . METHODS A volunteer sample of 874 healthy novice runners who started a self-structured running regimen were provided a global-positioning-system watch . After each running session during the study period , participants were categorized into 1 of the following exposure groups , based on the progression of their weekly running distance : less than 10 % or regression , 10 % to 30 % , or more than 30 % . The primary outcome was running-related injury . RESULTS A total of 202 runners sustained a running-related injury . Using Cox regression analysis , no statistically significant differences in injury rates were found across the 3 exposure groups . An increased rate of distance-related injuries ( patellofemoral pain , iliotibial b and syndrome , medial tibial stress syndrome , gluteus medius injury , greater trochanteric bursitis , injury to the tensor fascia latae , and patellar tendinopathy ) existed in those who progressed their weekly running distance by more than 30 % compared with those who progressed less than 10 % ( hazard ratio = 1.59 ; 95 % confidence interval : 0.96 , 2.66 ; P = .07 ) . CONCLUSION Novice runners who progressed their running distance by more than 30 % over a 2-week period seem to be more vulnerable to distance-related injuries than runners who increase their running distance by less than 10 % . Owing to the exploratory nature of the present study , r and omized controlled trials are needed to verify these results , and more experimental studies are needed to vali date the assumptions . Still , novice runners may be well advised to progress their weekly distances by less than 30 % per week over a 2-week period Background : The incidence of acute hamstring injuries is high in several sports , including the different forms of football . Purpose : The authors investigated the preventive effect of eccentric strengthening of the hamstring muscles using the Nordic hamstring exercise compared with no additional hamstring exercise on the rate of acute hamstring injuries in male soccer players . Study Design : R and omized controlled trial ; Level of evidence , 1 . Methods : Fifty Danish male professional and amateur soccer teams ( 942 players ) were allocated to an intervention group ( 461 players ) or a control group ( 481 players ) . Players in the intervention group conducted a 10-week progressive eccentric training program followed by a weekly seasonal program , whereas players in the control group followed their usual training program . The main outcome measures were numbers of overall , new , and recurrent acute hamstring injuries during 1 full soccer season . Results : Fifty-two acute hamstring injuries in the control group compared with 15 injuries in the intervention group were registered . Comparing intervention versus the control group , overall acute hamstring injury rates per 100 player seasons were 3.8 versus 13.1 ( adjusted rate ratio [ RR ] , 0.293 ; 95 % confidence interval [ CI ] , 0.150 - 0.572 ; P < .001 ) . New injury rates per 100 player seasons were 3.1 versus 8.1 ( RR , 0.410 ; 95 % CI , 0.180 - 0.933 ; P = .034 ) , whereas recurrent injury rates per 100 player seasons were 7.1 versus 45.8 ( RR , 0.137 ; 95 % CI , 0.037 - 0.509 ; P = .003 ) . Number needed to treat [ NNT ] to prevent 1 acute hamstring injury ( new or recurrent ) is 13 ( 95 % CI , 9 - 23 ) players . The NNT to prevent 1 new injury is 25 ( 95 % CI , 15 - 72 ) players , and NNT to prevent 1 recurrent injury is 3 ( 95 % CI , 2 - 6 ) players . Conclusion : In male professional and amateur soccer players , additional eccentric hamstring exercise decreased the rate of overall , new , and recurrent acute hamstring injuries Abstract Pedersen , MT , And ersen , LL , Jørgensen , MB , Søgaard , K , and Sjøgaard , G. Effect of specific resistance training on musculoskeletal pain symptoms : Dose-response relationship . J Strength Cond Res 27(1 ) : 229–235 , 2013—The purpose of this study was to investigate the dose-response of strength training for relieving musculoskeletal pain in female office workers . The relation between the dose of training in terms of total training volume ( sets × repetitions × load reported in training diaries ) during a 16-week strength training program and changes in pain ( calculated as pain index , 0–100 % , from self-reported intensities and duration s of pain in the upper body and low back ) was determined by regression analysis . The women were part of a r and omized controlled trial with specific strength training ( SRT ) , all-round physical exercise ( APE ) , and a reference group ( REF ) . Results showed that pain index in SRT and APE decreased significantly from baseline to follow-up \n Output:\n " }, { "from": "agent", "value": "Conclusion The included studies were generally well design ed and executed , had high compliance rates , were safe , and attained consistently favourable results across four different acute and overuse injury outcomes despite considerable differences in population s and interventions .\nIncreasing strength training volume and intensity were associated with sports injury risk reduction .\nThree characteristically different approaches to prevention mechanisms were identified and incorporated into contemporary strength training recommendations" } ]

[ { "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 , r and omized study of 158 patients undergoing in-vitro fertilization ( IVF ) and embryo transfer was conducted to evaluate whether a shortened exposure of oocytes to spermatozoa enhances oocyte development , and subsequently influences the IVF outcome . A comparison was made between conventional treatment time and shorter exposure of retrieved oocytes to spermatozoa . Fertilization and cleavage rates , embryo quality , implantation and pregnancy rates in the study group ( short exposure ) versus controls ( st and ard IVF procedure ) were evaluated . Fertilization ( 56 versus 61 % ) and cleavage rates ( 96 versus 92 % ) were similar in the two groups respectively . However , embryo quality was significantly higher in the study group ( P < 0.05 ) . Moreover , the pregnancy and implantation rates were significantly increased ( 42.4 versus 26 % per embryo transfer , and 16 versus 10 % respectively ; P < 0.05 ) . Our results demonstrated that shorter exposure of oocytes to spermatozoa is superior to the st and ard time in IVF and may have a favourable effect on implantation rates by improving embryo quality OBJECTIVE To confirm whether brief exposure of human oocytes to spermatozoa in vitro results in equivalent fertilization rates and possibly better quality embryos than overnight coincubation and to determine if there was a difference in outcome with regard to the type of culture medium used . DESIGN Prospect i ve distribution of gametes between treatments in sequential patients . SETTING Assisted reproductive technology program in private hospital . PATIENT(S ) Consecutively treated subfertile couples entering an infertility program . INTERVENTION(S ) Assisted reproductive technology treatment for infertility involving oocyte retrieval and in vitro fertilization . MAIN OUTCOME MEASURE(S ) When possible , the outcome of fertilization and embryo quality were compared when gametes were coincubated for 1 hour or overnight . Two different formulations of human tubal fluid were compared in some cases . RESULT ( S ) There was no statistically significant difference in fertilization rates between a brief or overnight coincubation of gametes or between the two treatment groups with regard to the type of culture medium used . The quality of the embryos was significantly better in the 1-hour exposure group . The embryos in Basal XI human tubal fluid medium were of significantly better morphological quality than their siblings in D3 + human tubal fluid medium . CONCLUSION ( S ) Coincubation of oocytes and spermatozoa for a shorter period produced embryos of superior morphological quality than the generally accepted overnight protocol . A simple glucose and phosphate-free human tubal fluid medium result ed in early cleavage embryos of better morphological quality than a medium supplemented with glucose , taurine , and glutathione Human oocyte development was evaluated after a reduced time exposure to spermatozoa in vitro . A total of 119 patients were assigned to two study groups in a r and omized prospect i ve study in which each patient 's oocytes were exposed to spermatozoa for either 1 h ( group 1 - 58 patients ) or the st and ard 16 h incubation period ( group 2 - 61 patients ) . The fertilization rate obtained in group 1 was higher than in group 2 ( 285/393 , 73 % , and 272/410 , 66 % respectively ) , suggesting that the spermatozoa-oocyte interaction occurs within 1 h. This was confirmed in a study in vitro using fluorescently labelled spermatozoa and normal oocyte-cumulus complexes . Spermatozoa enter the cumulus complex within 15 min , traverse the cumulus layer within 3 h , and first appear in the oocyte cortex at 4 h post-insemination . The incidence of polyspermy was higher in oocytes exposed to spermatozoa for 16 h ( 3 % ) than for 1 h ( 1 % ) . There was no difference in the cleavage rate or morphological characteristics of embryos from both study groups . However , when evaluating the timing of embryo development , group 1 generated a significantly higher percentage of four to five cell embryos when compared to group 2 ( 55 versus 39 % ; P < 0.001 ) , documented at 40 h post-insemination . The implantation and pregnancy rates for group 1 were 11 and 28 % , while the corresponding rates for group 2 were 8 and 15 % . This suggests that a reduced exposure of oocyte to spermatozoa favours embryo viability , possibly due to a decrease in potential damage from sperm metabolic waste products Purpose : Recent studies showed a beneficial effect of reducing the time of sperm – oocyte interaction on fertilization , division , and implantation rates of the oocytes obtained from r and omized patients . In the present study , the effects of reduced insemination time on fertilization and embryo development were evaluated by using sibling oocytes from the same patient . Methods : A total of 464 oocytes from 36 patients was r and omly allocated to be inseminated for either 1 hr ( reduced ) or 18 hr ( regular ) . Results : Fertilization rates were not significantly different between reduced ( 135/229 ; 59 % ) and regular ( 150/235 ; 64 % ) groups . Cleavage rates and embryo quality were similar in both groups . A total of 135 embryos ( 73 from the reduced and 62 from the regular group ) was transferred to 36 patients . Thirty-four embryos implanted in 18 patients ( 25.2 % implantation and 50.0 % pregnancy rates ) . Conclusions : Fertilization , cleavage , and embryo development from 1-hr insemination is comparable , not superior , to those from an 18-hr insemination time , which is commonly used in in vitro fertilization programs . These data suggest that reduced insemination time can be used during in vitro fertilization to avoid unnecessarily longer exposure to spermatozoa BACKGROUND Traditionally oocytes have been exposed to sperm overnight , for 16 - 20 h. This long period of co-incubation , however , has been shown to create problems with high levels of reactive oxygen species ( ROS ) , which may affect embryo viability and cause hardening of the zona pellucida . Recently , a positive effect of reducing the co-incubation time to 90 - 120 min was reported . The objective of this study was to evaluate whether a further reduction of the co-incubation period could benefit the outcome of IVF . METHODS In this prospect i ve study , 777 sibling oocytes from 81 women undergoing IVF were divided via alternate allocation to co-incubation for either 30 s ( ultrashort co-incubation ) ( group A ) or for 90 min ( st and ard co-incubation ) ( group B ) . Endpoints were normal fertilization ( two-pronuclear , 2PN ) , polyspermy ( > 2PN ) , embryo quality ( EQ ) , clinical pregnancy ( CP ) and implantation ( IR ) . RESULTS The normal fertilization rates of the two groups were comparable : group A 58.6 % versus group B 58.0 % . Significantly lower rates of polyspermy were seen in group A compared to group B ( 2.8 versus 7.2 % , P = 0.008 ) . No statistically significant differences in EQ , CP or IR were seen . CONCLUSION This is the first study demonstrating the achievement of good fertilization rates in IVF with ultrashort co-incubation . Significantly lower rates of polyspermy were seen in the group with ultrashort compared to the st and ard co-incubation group . Further studies are , however , needed in order to evaluate whether ultrashort co-incubation has any effect on the outcome of IVF Comparisons were made among techniques used to treat male factor infertility . Patients with semen quality below that recognized by World Health Organization criteria as normal had a better success rate when treated by gamete intrafallopian transfer than by in vitro fertilization ( 25 % v. 7 % pregnancy rate per patient ) . When < 2 x 10(6 ) motile sperm were recovered , the fertilization rate and embryo cleavage rate were higher for microdrop insemination than for conventional insemination . When 7000 - 370,000 motile sperm were recovered , microdrop insemination result ed in a higher fertilization rate ( 46 % ) and a higher incidence of pregnancies ( 23 % of patients treated ) than subzonal sperm microinjection ( SUSM ) . However , for patients with 5000 - 50,000 motile sperm , the immediate transfer of SUSM oocytes to the Fallopian tube increased pregnancy rates for this technique to 24 % of patients treated . Direct microinjection of epididymal sperm from azoospermic men into the cytoplasm of oocytes result ed in pronuclear formation in 27 % of oocytes ; in comparison , pronuclear formation occurred in 5 % of SUSM oocytes . These data led to formulation of a logical treatment programme for male factor infertility Altering the coincubation time for spermatozoa and oocytes in vitro leads to varying results . Some authors suggest that longer exposure of spermatozoa to oocytes through coincubation is detrimental to fertilization and /or embryo development , possibly because of reactive oxygen species produced by the spermatozoa ( 1–5 ) . Other studies indicate that a decreased exposure time does not alter fertilization rates ( 3,6–9 ) and may even improve such rates ( 10–13 ) . In this report , we describe the results of our r and omized study on the effects of two coincubation times on in vitro fertilization ( IVF ) rates and embryo quality OBJECTIVE To examine the benefits of short coincubation of gametes compared to prolonged incubation in in vitro fertilization ( IVF ) . DESIGN Prospect i ve r and omized controlled study . SETTING Hospital-based fertility center . PATIENT(S ) One hundred thirty patients ( group 1 ) and 129 patients ( group 2 ) . INTERVENTION(S ) Oocytes from group 1 were exposed to spermatozoa for 2 hours , and oocytes from group 2 were exposed to spermatozoa for 20 hours . MAIN OUTCOME MEASURE(S ) Fertilization and cleavage rates , embryo quality , and pregnancy and implantation rates were evaluated . Estradiol ( E(2 ) ) and progesterone ( P(4 ) ) levels were measured in the wells of culture dishes after 2-hour exposure of oocytes/zygotes to spermatozoa in group 1 and after 20-hour exposure in both the groups . RESULT ( S ) There was no difference between the two groups in the fertilization rate and the number of embryos obtained . However , the proportion of grade 1 embryos was significantly higher among group 1 compared to group 2 patients . Clinical pregnancy and implantation rates were significantly higher among group 1 compared to group 2 . The significantly higher levels of E(2 ) and P(4 ) in the 20-hour cultures compared with the 2-hour cultures may have been detrimental to embryo quality , pregnancy , and implantation rates . CONCLUSION ( S ) Coincubation of gametes for 2 hours with st and ard or high insemination concentrations of spermatozoa significantly improved embryo quality and the pregnancy and implantation rates compared with overnight incubation of gametes Purpose Evaluate the effect of short gamete incubation on fertilization rate and embryo quality . Methods A prospect i ve study has been performed . Two thous and five hundred and forty seven sibling oocytes from 240 couples undergoing IVF attempts were allocated to a short ( 1 h ) or a st and ard ( 18 h ) insemination procedure . Diploid fertilization rate ( two pronuclei , 2PN ) , polyspermy ( > 2PN ) and embryo quality were compared . Results The fertilization rate was statistically lower in the short insemination group compared to the st and ard insemination one ( 64.9 % and 70.1 % ; P = 0.039 ) , with a similar polyspermy rate observed between the two groups . A slight , but non significant , increase was observed concerning good embryo quality rate in the short insemination group when compared to the st and ard insemination , both at day 2 ( 60.1 vs. 58.1 % ; P = 0.06 ) and day 3 ( 53.2 vs. 48.5 % ; P = 0.22 ) . Conclusion This new study highlights that a 1 h gamete exposure decreases the fertilization rate and does not improve embryo quality compared with a st and ard 18 h insemination procedure Abstract Purpose : To investigate whether very short exposure ofmature oocytes to sperm in vitro may affect the fertilizationrates , embryo cleavage rates , and embryo quality betweensibling oocytes in the same patient . Methods : Sibling oocytes of the same patient from 23 oocyte collection cycles were r and omly allocated to the study group , with a 1-hr or 3-hr sperm — oocyte incubation , or the controlgroup with the st and ard overnight gamete co-incubation . The fertilization rates , cleavage rates , and subsequentembryo quality were evaluated . Results : Our results showed no statistically significant differencesin fertilization rates , embryo cleavage rates , and quality of the embryos between the study group and thecontrol group . Conclusions : Since the present study showed that long exposureof the oocyte to sperm has no advantage over shortexposure , we prefer shortening the oocyte — \n Output:\n " }, { "from": "agent", "value": "Reduced gamete exposure time may be associated with beneficial 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 Aim - PREDICTIVE ( Predictable Results and Experience in Diabetes Through Intensification and Control to Target : an International Variability Evaluation ) is a multi-national study design ed to evaluate the safety and efficacy of insulin detemir ( Levemir ® ) in \" real world \" medical practice . The aim of the study is to report the PREDICTIVE results of the Belgian type 1 diabetic cohort . Methods – Two hundred and thirty-two patients treated with a basal-bolus insulin scheme were considered for analysis . Seventy-eight percent of those patients were previously treated with insulin glargine as a basal insulin , while 22 % received NPH , before switching to Levemir ® . Results - Mean age and duration of diabetes were 45±15 and 18±13 years , respectively ( means±SD ) . HbA1C was 8.3±1.2 % . We observed ( at weeks 12 and 26 after baseline ) a significant reduction in all hypoglycaemic events including major hypoglycaemias after switching to detemir ( p<0.0001 ) . There was no change in HbA1C . Fasting blood glucose decreased from 170±49 to 158±45 mg/dl at week 26 ( p<0.009 ) , while fasting blood glucose variability was reduced from 69±35 to 57±30 mg/dl at week 26 ( p<0.0001 ) . Total insulin doses increased during the trial from 0.74±0.28 to 0.82±0.14 U/kg/day ( p<0.0001 ) . No weight gain was observed during the study . Patient ’s satisfaction increased significantly ( from 6.3±1.5 to 7.2±1.6 at week 26 , p<0.0001 ) . Conclusion - This report from the Belgian cohort of PREDICTIVE extends the safety and efficacy data of insulin detemir in type 1 diabetic patients treated with a basal-bolus insulin scheme AIMS The IMPROVE observational study evaluated the safety profile and effectiveness of biphasic insulin aspart 30/70 ( BIAsp 30 ) in patients with type 2 diabetes in routine practice in 11 countries . METHODS Patients who initiated insulin therapy with , or switched existing insulin therapy to , BIAsp 30 in routine care were eligible for this 26-week , non-interventional observational study . Data on adverse events , hypoglycaemia and glycaemic parameters were obtained from patients ' diaries and medical notes . Question naire-based patient treatment satisfaction was also measured . We report global results and , uniquely for a diabetes observational study , country-specific data . RESULTS A total of 52,419 patients were enrolled from three pre study treatment groups : no pharmaceutical therapy ( n = 8966 , diabetes duration 2.0 years , baseline HbA1c 9.9 % ) , oral antidiabetic drugs ( OADs ) only ( n = 33,797 , diabetes duration 7.4 years , baseline HbA1c 9.2 % ) and insulin + /- OADs ( n = 9568 , diabetes duration 10.4 years , baseline HbA1c 9.3 % ) . At final visit , HbA1c , fasting and postpr and ial blood glucose were significantly reduced from baseline in all subgroups ( no pharmaceutical therapy : -3.1 % , -5.9 and -9.0 mmol/l , respectively ; OADs-only : -2.1 % , -4.1 and -6.1 mmol/l ; insulin + /- OADs : -2.0 % , -3.3 and -5.1 mmol/l ) . Major hypoglycaemia rates decreased in all subgroups ; minor hypoglycaemia increased in the insulin-naïve groups . There was no mean weight gain across subgroups . Across all countries , glycaemic parameters and major hypoglycaemia were reduced ; weight increases were seen in some countries . Treatment satisfaction increased in all subgroups and countries following BIAsp 30 therapy . CONCLUSIONS Initiating insulin with , or switching insulin therapy to , BIAsp 30 in routine care result ed in improved glycaemic control , reduced major hypoglycaemia and greater treatment satisfaction Aims : The international IMPROVE ™ observational study investigated the safety profile and effectiveness of biphasic insulin aspart 30/70 ( BIAsp 30 ) in the routine treatment of patients with type 2 diabetes . We present analyses for the subgroup of patients who switched from basal insulin to BIAsp 30 . Methods : Patients in routine care who started insulin therapy with or switched to BIAsp 30 from existing insulin regimens were eligible for this 26-week study . This analysis includes only patients previously treated with basal insulin . Outcomes including adverse events , hypoglycaemic events and glycaemic profile were recorded from patients ’ notes , recall and diaries . Results : Of the 748 patients included ( age 59.7 ± 11.8 years , diabetes duration 11.4 ± 7.3 years , baseline HbA1c 9.1 ± 1.6 % ) , 497 were previously using human neutral protamine Hagedorn ( NPH ) insulin and 245 analogue basal insulin . Overall , major and minor hypoglycaemia rates decreased from baseline to final visit ( major : 0.171 to 0.011 ; minor : 9.70 to 5.89 events/patient-year ) and were similar between the subgroups . HbA1c and fasting blood glucose were significantly reduced from baseline ( NPH pre study : −1.6 % , −2.4 mmol/l ; analogue basal pre study : −1.8 % , −2.4 mmol/l ) , as was postpr and ial blood glucose , with 33.8 % of patients achieving the HbA1c target < 7 % without hypoglycaemia . Insulin dose increased slightly from pre study ( 0.33 ± 0.21 U/kg ) , baseline ( 0.40 ± 0.20 U/kg ) to final visit ( 0.52 ± 0.26 U/kg ) ; most patients ( 76 % ) followed a twice-daily regimen at final visit . Body weight did not change significantly and treatment satisfaction increased . Conclusions : Patients with type 2 diabetes inadequately controlled on basal insulins may improve their glycaemic control by intensification to BIAsp 30 therapy Background : The First Basal Insulin Evaluation ( FINE ) Asia study is a multinational , prospect i ve , observational study of insulin-naïve Type 2 diabetes mellitus ( T2DM ) patients in Asia , uncontrolled ( A1c ≥ 8 % ) on oral hypoglycemic agents , design ed to evaluate the impact of basal insulin initiation . Methods : Basal insulin was initiated with or without concomitant oral therapy and doses were adjusted individually . All treatment choices , including the decision to initiate insulin , were at the physician 's discretion to reflect real-life practice . Results : Patients ( n= 2679 ) from 11 Asian countries were enrolled ( mean [ ±SD ] duration of diabetes 9.3 ± 6.5 years ; weight 68.1 ± 12.7 kg ; A1c 9.8 ± 1.6 % ) . After 6 months of basal insulin ( NPH insulin , insulin glargine , or insulin detemir ) , A1c decreased to 7.7 ± 1.4 % ; 33.7 % patients reached A1c < 7 % . Fasting blood glucose ( FBG ) decreased from 11.7 ± 3.6 to 7.2 ± 2.5 mmol/L and 36.8 % of patients reached FBG < 6.1 mmol/L. The mean daily insulin dose prescribed increased marginally from 0.18 to 0.23 U/kg per day at baseline to 0.22–0.24 U/kg per day at Month 6 . Mean changes in body weight and reported rates of hypoglycemia were low over the duration of the study . Conclusions : Initiation of insulin therapy is still being delayed by approximately 9 years , result ing in many Asian patients developing severe hyperglycemia . Initiating insulin treatment with basal insulin was effective and safe in Asian T2DM patients in a real-world setting , but insulin needs may differ from those in Western countries BACKGROUND The Initiation of Insulin to reach A1C Target ( INITIATEplus ) trial studied the effect of self-titrating biphasic insulin aspart 70/30 ( BiAsp 30 ) twice daily during 24 weeks in insulin-naïve patients with type 2 diabetes who were poorly controlled by oral medication , and originally r and omized according to frequency of dietary counseling interventions . OBJECTIVE The purpose of this study was to compare the efficacy and tolerability of biphasic insulin aspart 70/30 ( BIAsp 30 , NovoLog Mix 70/30 ) in INITIATEplus patients ≤65 versus > 65 years old , irrespective of dietary counseling frequency , and to test the hypothesis that self-titrating BIAsp 30 in patients > 65 years old could be well-tolerated and effective in this age group . METHODS An exploratory post hoc sub analysis , using st and ard statistical methods , was performed on patients stratified according to age . Data collected from 3492 patients in the intent-to-treat population who were ≤65 years old and 716 patients who were > 65 years old compared glycosylated hemoglobin ( HbA(1c ) ) and plasma glucose changes from baseline . Hypoglycemia rates and adverse event ( AE ) incidence were compared for the tolerability population of 4007 patients ≤65 years old and 805 patients > 65 years old . RESULTS Baseline-adjusted HbA(1c ) changes for patients ≤65 versus > 65 years old were -2.38 % versus -2.73 % ( P < 0.0001 ) , with final HbA(1c ) achieving 7.55 % and 7.06 % , respectively . Thirty-nine percent of patients ≤65 years old achieved HbA(1c ) ≤7 % compared with 51 % of patients > 65 years old . Baseline-adjusted fasting plasma glucose decreases were greater for the > 65 year old population ( 85.2 vs 91.2 mg/dL ; P = 0.004 ; ≤65 vs > 65 years old , respectively ) . Minor hypoglycemia was reported in 9.7 % and 7.7 % of patients ≤65 versus > 65 years old , respectively ( 0.52 vs 0.41 episodes per patient per year [ ppy ] ; P = 0.01 ) . Major hypoglycemia occurred in 1.5 % and 3.1 % of patients ( 0.05 vs 0.14 episodes ppy , ≤65 vs > 65 years old , respectively ; P < 0.0001 ) . Nocturnal major hypoglycemia was reported for 0.4 % and 0.6 % of patients ( P = 0.0028 ) , whereas nocturnal minor hypoglycemia was reported for 3.8 % and 2.6 % ( P = 0.007 ) of patients ≤65 and > 65 years old , respectively . AEs were reported for 24 % and 28 % of patients ≤65 and > 65 years old , respectively , serious AEs were reported for 4 % and 9 % of patients , respectively , and AE-related withdrawals were reported for 1.3 % and 2 % of patients , respectively . CONCLUSIONS Self-titrated biphasic insulin aspart 70/30 was found to be well-tolerated and effective in type 2 diabetes patients > 65 years old , as well as in patients ≤65 years old . HbA(1c ) and fasting plasma glucose decreases were significantly ( P < 0.05 ) higher for patients > 65 years old versus patients ≤65 years old . Tolerability was indicated by major and minor hypoglycemia rates at or below < 0.5 episodes ppy in both age groups . Overall rates of AE and serious AEs were higher among patients > 65 years ; withdrawals related to AEs were 2 % compared with 1.3 % in the younger age group AIM To examine the criteria that may influence physicians ' choice of starting insulin in type 2 diabetes patients in routine practice in Algeria as a sub- analysis of the A₁chieve study . METHODS A₁chieve was a 24-week international , prospect i ve , non-interventional study conducted to evaluate the safety and effectiveness of biphasic insulin aspart 30 ( BIAsp 30 ) , insulin detemir ( IDet ) , or insulin aspart alone or in combination , in real-life clinical setting s. We report an analysis of baseline data from insulin-naive patients initiating basal or premix insulin from the Algeria cohort ( n = 1494 ) . Demographic and anthropometric data , blood glucose control at inclusion , microvascular complications , and pre- study therapy was compared between the two groups . RES \n Output:\n " }, { "from": "agent", "value": "Conclusions Our review indicates that SHE rates differ between patients depending on treatment regimen .\nHowever , SHEs are also driven by other factors ." } ]

[ { "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 Antidepressants are effective in adults with pain-related functional gastrointestinal disorders . We investigated the effectiveness of citalopram in the treatment of childhood functional abdominal pain ( FAP ) . METHODS Children with FAP , based on the Rome III criteria ( n = 115 , aged 6 - 18 years ) , were r and omized to receive either citalopram 20 mg/day or placebo for 4 weeks . Treatment response was defined as ≥ 2 point reduction in the 6-point Faces pain rating scale or ' no pain ' . Depression , anxiety , somatization , and physician-rated global severity and improvement were also evaluated . Patients were followed up for 8 weeks after medication period . KEY RESULTS Eighty-six patients completed the medication ( 43 in each group ) . Response rate in the citalopram and placebo groups based on per- protocol ( intention-to-treat ) analysis was 55.8 % ( 40.6 % ) and 39.5 % ( 30.3 % ) at week 4 ( p = 0.097 [ 0.169 ] ) and 72.0 % ( 52.5 % ) and 53.4 % ( 41.0 % ) at week 12 ( p = 0.059 [ 0.148 ] ) , respectively . In per- protocol analysis , more reduction was observed in pain ( F = 3.84 , p = 0.024 ) and global severity scores ( F = 4.12 , p = 0.021 ) in the citalopram group compared with the placebo group over the study period . Such differences were not present in the intention-to-treat analysis . No difference was found between the two groups regarding change in depression , anxiety , or somatization score over the study . CONCLUSIONS & INFERENCES Overall , we found a trend toward the effectiveness of citalopram in the treatment of children with FAP . Trials with longer treatment duration in larger sample s of patients are required in this regard Background There are no approved medications for juvenile fibromyalgia ( JFM ) , a disorder that is often under-diagnosed . The effects of milnacipran , a drug approved for the management of fibromyalgia ( FM ) in adults , was assessed in a clinical trial program for JFM . Methods Patients , ages 13–17 years who met the Yunus and Masi criteria for JFM and /or 1990 American College of Rheumatology criteria for FM , were enrolled in a responder-enriched , r and omized withdrawal trial . After receiving open-label milnacipran ( 8 weeks ) , patients with ≥50 % improvement in pain underwent double-blind r and omization ( 1:2 ) to either placebo or continuing treatment with milnacipran ( 8 weeks ) . All patients , including those who did not meet the r and omization criteria for double-blind withdrawal , were allowed to enter an extension study with open-label milnacipran ( up to 52 weeks ) . The primary endpoint was loss of therapeutic response ( LTR ) during the double-blind period . Additional outcome measures included the Patient Global Impression of Severity ( PGIS ) , Pediatric Quality of Life Inventory ( PedsQL : Generic Core Scales , Multidimensional Fatigue Scale ) , and Multidimensional Anxiety Scale for Children ( MASC ) . Safety assessment s included adverse events ( AEs ) , vital signs , electrocardiograms , and laboratory tests . Results The milnacipran program was terminated early due to low enrollment . Because only 20 patients were r and omized into the double-blind withdrawal period , statistical analyses were not conducted for the LTR endpoint . However , 116 patients entered the open-label period of the initial study and 57 participated in the open-label extension study . Their experience provides preliminary information about the use of milnacipran in JFM patients . During both open-label periods , there were mean improvements in pain severity , PGIC , PedsQL , and MASC scores . No unexpected safety issues were detected . The most commonly reported treatment-emergent AEs were nausea , headache , vomiting , and dizziness . Mean increases in heart rate and blood pressure were observed , and were consistent with the AE profile in adults with FM . Conclusions The open-label findings provide preliminary evidence that milnacipran may improve symptoms of JFM , with a safety and tolerability profile that is consistent with the experience in adult FM patients . Future trial design s for JFM should consider the relatively low recognition of this condition compared to adult FM and the difficulties with enrollment . Trial registration NCT01328002 ; & NA ; The current analysis compares changes in pain with changes in function and health status in individuals with painful diabetic peripheral neuropathy ( DPN ) . The post hoc analysis is based on a 12 week , multinational , placebo‐controlled trial of pregabalin in which 401 patients were r and omized to treatment . Study measures included the Brief Pain Inventory short‐form ( BPI‐sf ) , EQ‐5D and other patient‐reported outcomes . Cutpoints were derived on the BPI‐sf 0–10 average pain numeric rating scale [ NRS ] to classify pain grade s of “ mild ” ( 1–3 ) , moderate ( 4–6 ) and severe ( 7–10 ) , adjusting for geographical regions where data were collected . Two different metrics were used to classify the importance of change in pain severity from baseline to 12 weeks : changes in pain severity grade s ( defined by cutpoint categories ) and percent reduction in the NRS ( categories ranging from 0–9 % to ≥50 % ) . An improvement in one pain grade or a ≥30 % reduction in the NRS served as determinants of a clinical ly important difference . Patients with a one‐ grade reduction in pain severity , either from “ severe‐to‐moderate ” or “ moderate‐to‐mild , ” had a 3‐point improvement the BPI‐sf Pain Interference Index ( PII ; a composite measure of function ) ; a reduction from “ severe‐to‐mild ” pain corresponded to a 6‐point improvement in the PII . Similarly , a reduction in the NRS of ≥30 % and ≥50 % corresponded to a 3‐point and a 5‐point improvement in the PII , respectively . Changes in pain were also associated with changes in health status . Results suggest that patients whose pain is not reduced to a mild level of severity can still experience clinical ly important changes in function and health status Objectives Evaluate the efficacy and safety of duloxetine at doses up to 120 mg once daily in patients with fibromyalgia . Methods This was a phase 3 , 60-week study , which included an 8-week open-label period followed by a 52-week , r and omized , double-blind period . Patients received duloxetine 30 mg daily for 1 week and duloxetine 60 mg daily for 7 weeks and were then r and omized to receive either 60 or 120 mg daily ( 1:2 ratio ) . Results Enrolled patients ( N=350 , 95.7 % female ) exhibited moderate disease symptoms at study entry ( Brief Pain Inventory average pain=6.7 , Clinical Global Impression of Severity=4.1 , and Patient 's Global Impression of Severity=4.1 ) . Significant pain reduction in patients was observed during the open-label study phase . This pain reduction continued during the 52-week double-blind study phase , as demonstrated by additional mean decreases in the Brief Pain Inventory average pain score within both duloxetine groups . The most common ( ≥15 % ) treatment-emergent adverse events ( overall phase ) were nausea , headache , insomnia , dizziness , constipation , and dry mouth . Seventy-four ( 21.1 % ) patients reported adverse events as a reason for discontinuation [ most common ( > 1 % ) were insomnia , vomiting , diarrhea , dizziness , and nausea ] . The mean change ( SD ) in sitting systolic blood pressure ( mm Hg ) was −0.1 ( 14.4 ) , in sitting diastolic blood pressure was −0.2 ( 9.6 ) , in sitting pulse rate was 1.9 ( 10.4 ) bpm , and in weight was 0.7 ( 4.3 ) kg . Discussion The profile of duloxetine for the long-term treatment of fibromyalgia was consistent with that seen in other indications for which the drug is currently marketed Abstract Background Treatment of neuropathic pain in children is challenging , and requires a multimodal approach of pharmacologic , physical , and psychological therapies ; however there is little evidence to guide practice . Amitriptyline and gabapentin are first-line drugs for treating neuropathic pain in adults , yet no studies have examined their efficacy , or compared them directly , to determine which might be better for pain relief and sleep disturbance in children . Methods After informed consent was obtained , 34 patients aged 7–18 years diagnosed with complex regional pain syndrome type I ( CRPS I ) or a neuropathic pain condition were r and omly allocated to receive either amitriptyline or gabapentin . Patients were followed for 6 weeks and assessed for pain intensity , sleep quality and adverse events . We blinded study personnel , including health-care providers , participants , parents , the research coordinator and the data analyst . Patients then completed quantitative sensory testing ( QST ) and a psychosocial pain assessment with the team psychologist , within 1–3 days of the start of the trial . Results At the end of the 6-week trial , patients on both drugs had important reductions in pain , having surpassed the minimally important difference ( MID ) of 1 . The difference between the groups however was not statistically significant . For the secondary outcomes , we found no statistically significant difference between the two drugs in sleep score or adverse events suggesting that both drugs improve sleep score to a similar degree and are equally safe . Conclusions Amitriptyline and gabapentin significantly decreased pain intensity scores and improved sleep . There were no significant differences between the two drugs in their effects on pain reduction or sleep disability . Implication s Although larger , multi-centred trials are needed to confirm our findings , including longterm follow-up , both drugs appear to be safe and effective in treating paediatric patients in the first-line treatment of CRPS I and neuropathic pain over 6-weeks AIMS To compare the effectiveness of adding cyclobenzaprine , tizanidine , or placebo to patient education and a self-care management program for patients with myofascial pain and specifically presenting with jaw pain upon awakening . METHODS Forty-five patients with a diagnosis of myofascial pain based on the guidelines of the American Academy of Orofacial Pain participated in this 3-week study . The subjects were r and omly assigned into one of three groups : placebo group , TZA group ( tizanidine 4 mg ) , or CYC group ( cyclobenzaprine 10 mg ) . Patients were evaluated for changes in pain intensity , frequency , and duration by using the modified Severity Symptoms Index and changes in sleep quality with the use of the Pittsburgh Sleep Quality Index . Data were analyzed by ANOVA and post-hoc or nonparametric statistical tests as appropriate . RESULTS All three groups had a reduction in pain symptoms and improvement of sleep quality based on a comparison of pretreatment and treatment scores . However , no significant differences among the groups were observed at the posttreatment evaluation . CONCLUSION The use of tizanidine or cyclobenzaprine in addition to self-care management and patient education was not more effective than placebo for the management of patients with myofascial jaw pain upon awakening & NA ; Chronic pain is associated with a range of other problems , including disturbed sleep , depression , anxiety , fatigue , reduced quality of life , and an inability to work or socialise . We investigated whether good symptom control of pain ( using definitions of moderate and substantial benefit ) is associated with improvement in other symptoms . Individual patient data from four r and omised trials in fibromyalgia ( 2575 patients ) lasting 8–14 weeks were used to calculate percentage pain reduction for each completing patient ( 1858 ) , divided into one of five groups according to pain reduction , irrespective of treatment : substantial benefit – ≥50 % pain reduction ; moderate – 30 % to < 50 % ; minimal – 15 % to < 30 % ; marginal – 0 % to < 15 % ; worse – < 0 % ( increased pain intensity ) . We then calculated change from baseline to end of trial for measures of fatigue , function , sleep , depression , anxiety , ability to work , general health status , and quality ‐adjusted life year ( QALY ) gain over a 12‐month period . Substantial and moderate pain intensity reductions were associated with statistically significant reduction from baseline by end of trial in all measures , with values by trial end at or approaching normative values . Substantial pain intensity reduction result ed in 0.11 QALYs gained , and moderate pain intensity reduction in 0.07 QALYs gained over a 12‐month period . Substantial and moderate pain intensity reduction predicts broad beneficial outcomes and improved quality of life that do not occur without pain relief . Pain intensity reduction is a simple and effective predictor of which patients should continue treatment , and which should discontinue and try an alternative therapy Objective ( Background ): Amitriptyline ( AT ) is a st and ard therapy for postherpetic neuralgia ( PHN ) . Our hypothesis was that nortriptyline ( NT ) , a noradrenergic metabolite of AT , may be more effective . Methods : A r and omized , double-blind , crossover trial of AT versus NT was conducted in 33 patients . Results : Thirty-one patients completed the trial . Twenty-one of 31 ( 67.7 % ) had at least a good response to AT or NT , or both . We found no difference with regard to relief of steady , brief , or skin pain by visual analog scales for pain and pain relief ; mood ; disability ; satisfaction ; or \n Output:\n " }, { "from": "agent", "value": "The clinical impression from extended use over many years is that antidepressants are useful for some neuropathic pain symptoms , and that effects on pain relief are divorced and different from effects on depression ; for example , the effects of tricyclic antidepressants on pain may occur at different , and often lower , doses than those on depression .\nWe identified only a small number of studies with small numbers of participants and insufficient data for analysis .As we could undertake no meta- analysis , we are unable to comment about efficacy or harm from the use of antidepressants to treat chronic non-cancer pain in children and adolescents .\nThere is evidence from adult r and omised controlled trials that some antidepressants , such as amitriptyline , can provide some pain relief in certain chronic non-cancer pain conditions .\nThere is no evidence from r and omised controlled trials to support or refute the use of antidepressants to treat chronic non-cancer pain in children or adolescents" } ]

[ { "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 compare intraoperative blood loss , perioperative hematocrit , and transfusion requirements in patients undergoing radical retropubic prostatectomy ( RRP ) versus robotic-assisted laparoscopic prostatectomy ( RALP ) by a single surgeon . METHODS During a 14-month period , 279 patients with localized carcinoma of the prostate were prospect ively enrolled in this comparative study . The decision of which surgical approach to use was by patient choice . Of the 279 patients , 176 underwent RALP and 103 underwent RRP . The serum hematocrit was obtained preoperatively and 24 hours postoperatively in all patients . The intraoperative blood loss was recorded , and transfusion requirements were noted . RESULTS Patients in the RALP group had significantly less intraoperative blood loss compared with the RRP group ( mean 191 mL versus 664 mL , P < 0.001 ) . Additionally , the difference in the discharge hematocrit ( 36.8 % versus 32.8 % , P < 0.001 ) and the mean perioperative change in hematocrit ( 8.0 % decrease versus 10.7 % decrease , P < 0.001 ) were significant between the RALP and RRP groups , respectively . Three patients in the RRP group ( 2.9 % ) and one in the RALP group ( 0.5 % ) required transfusion of blood products ( P = 0.14 ) . CONCLUSIONS The results of this study have shown that RALP is associated with less intraoperative bleeding than RRP , and patients undergoing RALP have a greater serum hematocrit at hospital discharge . The lack of a statistically significant difference in blood transfusion was partially attributable to the low transfusion rate in both groups in this series OBJECTIVES Robotic assistance may enhance the precision of anatomic dissection and increase the feasibility of performing laparoscopic radical prostatectomy for most surgeons . We performed a prospect i ve comparison of 30 consecutive patients undergoing conventional radical retropubic prostatectomy ( RRP ) and 30 initial patients undergoing robot-assisted anatomic prostatectomy ( RAP ) at our institution . METHODS The study design was a prospect i ve nonr and omized comparison of anatomic RRP performed using the technique of Walsh and RAP performed with the da Vinci surgical system . We evaluated the baseline patient and tumor characteristics ( age , body mass index , serum prostate-specific antigen , Gleason score , and clinical stage ) , intraoperative parameters ( operative time , blood loss , and need for transfusion ) , postoperative parameters ( pain score , hospitalization duration , catheter duration ) , histopathologic parameters , and complications in the two groups . RESULTS The preoperative parameters were comparable for both groups of patients . The mean setup time for RAP was 0.95 hours . The mean operating time was 2.3 hours for RRP and 4.8 hours for RAP ( P < 0.001 ) . One patient required conversion from RAP to RRP because of a lack of progress . The mean blood loss was 970 mL for RRP and 329 mL for RAP ( P < 0.001 ) . The drop in hemoglobin was greater in the RRP group ( 4.4 versus 1.2 g in RAP ; P < 0.05 ) . The mean pain score on postoperative day 1 was 7 in the RRP group and 4 in RAP group ( P = 0.05 ) . The mean hospital stay was 56 hours in the RRP group and 36 hours in the RAP group ( P value not significant ) . Sixty-three percent of the RAP and 0 % of the RRP groups were discharged within 23 hours ( P < 0.001 ) . The mean duration of postoperative catheterization was 14 days for the RRP and 11 days for the RAP groups ( difference not significant ) . The pathologic stage , margin status , and prostate-specific antigen values were not different between the two groups . The setup time , operative time , blood loss amount , and catheterization duration were significantly reduced after the first 20 patients . CONCLUSIONS Currently , RAP is a longer procedure than RRP . However , the blood loss is minimal and patients feel less pain and are discharged earlier from the hospital . In our h and s , the margin status and complication rates were comparable for both techniques PURPOSE We developed a preoperative nomogram for prediction of lymph node metastases in patients with clinical ly localized prostate cancer . MATERIAL S AND METHODS The study was a retrospective , nonr and omized analysis of 7,014 patients treated with radical prostatectomy at 6 institutions between 1985 and 2000 . Exclusion criteria consisted of preoperative and rogen ablation therapy , salvage radical prostatectomy and pretreatment prostate specific antigen ( PSA ) greater than 50 ng/ml . Preoperative predictors of lymph node metastases consisted of pretreatment PSA , clinical stage ( 1992 TNM ) and biopsy Gleason sum . These predictors were used in logistic regression analysis based nomograms to predict the probability of lymph node metastases . RESULTS Overall 5,510 patients with complete clinical and pathological information were included in the study . Lymph nodes metastases were present in 206 patients ( 3.7 % ) . Pretreatment PSA , biopsy Gleason sum , clinical stage and institution represented predictors of lymph node status ( p < 0.001 ) . Bootstrap corrected predictive accuracy of the 3-variable nomogram ( clinical stage , Gleason sum and PSA ) was 0.76 . Inclusion of a fourth variable , which accounts for institutional differences in lymph node metastases , yielded an area under the receiver operating characteristics curve of 0.78 . The negative predictive value of our nomograms was 0.99 when they predicted 3 % or less chance of positive lymph nodes . CONCLUSIONS Using clinical information , we produced 2 calibrated and vali date d nomograms , which accurately predict pathologically negative lymph nodes in men with localized prostate cancer who are c and i date s for radical prostatectomy PURPOSE Minimally invasive surgery has been shown to decrease postoperative morbidity and length of stay for a number of surgical procedures . Furthermore , length of stay after open radical prostatectomy has decreased dramatically during the last decade . We examined differences in length of stay between a prospect ively evaluated cohort of patients who underwent radical retropubic prostatectomy and robot assisted laparoscopic prostatectomy . MATERIAL S AND METHODS Between January 2003 and March 2006 , 1,003 radical prostatectomies were performed at our hospital . Data were collected in prospect i ve fashion and a comparison was made between 374 patients who underwent radical retropubic prostatectomy and 629 who underwent robot assisted laparoscopic prostatectomy . Length of stay , factors influencing length of stay , readmission rates and unscheduled clinic or emergency room visits were evaluated . Patients in the 2 groups were treated using the same clinical care pathway . RESULTS Overall 94.3 % of patients in the radical retropubic prostatectomy group and 97.5 % in the robot assisted laparoscopic prostatectomy group were discharged home on or before postoperative day 1 . Mean length of stay in the radical retropubic and robot assisted laparoscopic prostatectomy groups was 1.25 ( median 1.09 ) and 1.17 days ( median 1.03 ) , which was similar and not statistically different ( p=0.27 ) . Readmission rates were similar in robot assisted laparoscopic and radical retropubic prostatectomy patients ( 7 % and 5 % , respectively , p=0.12 ) . Unscheduled clinic or emergency room visits were the same in the robot assisted laparoscopic and radical retropubic prostatectomy groups ( 10 % , p=0.95 ) . CONCLUSIONS Patients who underwent radical retropubic prostatectomy or robot assisted laparoscopic prostatectomy can be treated on the same clinical pathway . A targeted hospital discharge date of postoperative day 1 can be achieved in the majority of patients who underwent radical prostatectomy . Readmission rates or unscheduled hospital visits are necessary in a small percent of patients treated with an early discharge program , of which the majority are caused by ileus Background : The best technique of radical prostatectomy - open versus robot-assisted approach - is controversially discussed . In this study , we compared the complication rates of open and robot-assisted radical prostatectomy during the introduction and subsequent routine use of a da Vinci ® robotic device while open surgery remained the st and ard approach . Patients and Methods : Between January 1st , 2006 , and June 4th , 2012 , 2,754 men underwent radical prostatectomy at our department . Among them , 317 received robot-assisted and 2,438 open surgery . According to the requirements for prostate cancer centers certified by the Deutsche Krebsgesellschaft ( German Cancer Society ) , a prospect i ve data base recording perioperative complications was built up . The complication rates of open and robot-assisted radical prostatectomy were compared with the χ2 or Fisher exact test . The distributions of quantitative variables were compared with U tests . Results : Whereas the demographic factors favored patients selected for robot-assisted radical prostatectomy , there were no differences between open and robot-assisted surgery concerning length of stay , autologous blood transfusion rates and the incidence of perioperative complications . Conclusions : Open and robot-assisted radical prostatectomy had comparable complication rates . With better patient- and tumor-related parameters as well as decreasing transfusion rates in the robot-assisted subgroup , this observation might reflect the learning curves of the involved robotic surgeons We prospect ively compared , within the same center and during the same period of time , the perioperative parameters as well as the oncological and functional results of both open retropubic ( ORP ) and laparoscopic radical prostatectomy ( LRP ) . From September 1999 to September 2001 , 162 patients with prostate cancer were treated with radical prostatectomy , 77 using an open retropubic technique , and 85 by the laparoscopic extraperitoneal approach . We prospect ively recorded pre- , per- and postoperative parameters and complications , and evaluated the carcinological and functional results , comparing both approaches . There were no significant differences in the preoperative characteristics of the two groups . Mean operative time was statistically longer with LRP than with ORP ( 288 vs 168 min , P<0.0001 ) but median blood loss was decreased ( 400 vs 1,300 ml , P<0.0001 ) . Major complications occurred in a similar number of cases ( 5 % vs 2.4 % , NS ) while minor complications occurred more frequently with ORP ( 24.6 vs 11.8 % , P=0.003 ) . Pathological examination revealed a similar distribution of Gleason scores and stages in each group . Positive surgical margins in pT2 cases occurred in 7.8 % of LRP and 7.3 % of ORP . Continence rates ( no pad and no leakage at all ) were similar ( 83.9 % in ORP vs 80.7 % in LRP , NS ) . Potency rates were similar after 1 year in patients undergoing bilateral nerve sparing ( 55 % in ORP vs 65 % in LRP , NS ) . However , patients operated by LRP had more spontaneous erections . We conclude that this prospect i ve , comparative study shows that LRP , when performed in specialized centers , gives oncological and functional results comparable to open surgery OBJECTIVE To compare morbidity in two groups of patients who underwent retropubic or laparoscopic radical prostatectomy in the same period . PATIENTS AND METHODS The clinical and pathological data obtained in 50 consecutive patients who underwent retropubic radical prostatectomy ( RRP ) from January 2001 to December 2001 were compared to those obtained in 71 consecutive patients who were treated in the same year by extraperitoneal laparoscopic radical prostatectomy ( LRP ) . The two groups were comparable in terms of mean pre-operative PSA and biopsy Gleason score . The peri-operative data included operative time , intra-operative and post-operative transfusion rates , complication rates , hospitalization length , and duration of catheterization . The following pathological parameters were considered : Gleason score , pathological stage , and positive surgical margin rate . A comparative evaluation of continence recovery ( no pads and any leakage ) was made only in patients with follow-up longer than 12 months . RESULTS The two groups were comparable in terms of pathological stage and definitive Gleason score . Operating times were significantly shorter in RRP ( p<0.0001 ) . LRP patients showed higher autologous ( p<0.001 ) and eterologous transfusion ( p=0.03 ) . No significant difference was observed in terms of complication rates ( p=0.07 ) . The rectal injury rate was 2.8 % in the laparoscopic group . The mean post-operative hospital stay was 10.2+/-2 days in the surgery group and 7.2+/-3.4 days in the laparoscopy group ( p<0.001 ) . Catheterization time was 8.4+/-0.9 days in the surgery group and 8+/-2.8 days in the laparoscopy group ( p=0.27 ) . After 12 months , complete continence was achieved in \n Output:\n " }, { "from": "agent", "value": "With regard to the perioperative outcome , LRP and RALP were more time-consuming than RRP , but blood loss , transfusion rates , catheterisation time , hospitalisation duration , and complication rates were the most optimal in the laparoscopic approaches .\nWith regard to the functional and oncological results , RALP was found to have the best outcomes .\nConclusion : Our study confirmed the well-known perioperative advantage of minimally invasive techniques ; however , available data were not sufficient to prove the superiority of any surgical approach in terms of functional and oncologic outcomes .\nOn the contrary , cost comparison clearly supports RRP" } ]

[ { "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 purpose of this investigation was to study risk factors for Clostridium difficile infection ( CDI ) in an endemic setting . In a 34-month prospect i ve case – control study , we compared the risk factors and clinical characteristics of all consecutively diagnosed hospitalised CDI patients ( n = 93 ) with those of patients without diarrhoea ( n = 76 ) and patients with non-CDI diarrhoea ( n = 64 ) . The incidence of CDI was 17.5 per 10,000 hospital admissions . C. difficile polymerase chain reaction ( PCR ) ribotype 014 was the most frequently found type ( 15.9 % ) , followed by types 078 ( 12.7 % ) and 015 ( 7.9 % ) . Independent risk factors for endemic CDI were the use of second-generation cephalosporins , previous hospital admission and previous stay at the intensive care unit ( ICU ) . The use of third-generation cephalosporins was a risk factor for diarrhoea in general . We found no association of CDI with the use of fluoroquinolones or proton pump inhibitors ( PPIs ) . The overall 30-day mortality among CDI patients , patients without diarrhoea and patients with non-CDI diarrhoea was 7.5 % , 0 % and 1.6 % , respectively . In this endemic setting , risk factors for CDI differed from those in outbreak situations . Some risk factors that have been ascribed to CDI earlier were , in this study , not specific for CDI , but for diarrhoea in general . The 30-day mortality among CDI patients was relatively high There is a lack of information about the effectof omeprazole or other antisecretory drugs onintraduodenal pH. Aim of the study was to document thevariation over time of intraduodenal pH during a 24-hr period and to simultaneously study the effectof omeprazole 40 mg once daily on intragastric and intraduodenal pH in healthy H. pylori-negative subjects . In a r and omized , placebo-controlled study , eight subjects ( five women , three men , mean age 22.7years ) received oral 40 mg omeprazole or placebo oncedaily for eight days . On day 7 , intragastric and intraduodenal pH was measured continuously for 24 hr , using two miniature glass-membrane electrodesplaced in the stomach ( fundus ) and in the distal thirdof the duodenum . The 24-hr median intraduodenal pH was5.95 with placebo and 5.85 with omeprazole . Median intragastric pH was 1.68 without and 4.93 withomeprazole . During omeprazole therapy , intragastric pHfell below 4.0 in five of eight subjects . In the 2- and 3-hr postpr and ial periods , the percentage of time with pH < 5 was significantly reducedwith omeprazole . In healthy subjects , 24-hr median and postpr and ial pH in the distal part of the duodenum waslower than previously thought . Omeprazole significantly reduced the percentage of time with pH < 5postpr and ially . At night , intragastric pH fell below 4.0with omeprazole 40 mg once daily . Omeprazole does notchange 24-hr median intraduodenal pHsignificantly BACKGROUND Previous studies have examined the association between proton pump inhibitor ( PPI ) use and the risk of Clostridium difficile-associated disease ( CDAD ) , with conflicting results . Whether outpatient PPI use influences the risk of hospital admission for CDAD among older patients who have recently been treated with antibiotics is unknown . METHODS We conducted a population -based , nested case-control study of linked health care data bases in Ontario , Canada , from 1 April 2002 through 31 March 2005 . We identified patients aged > or = 66 years who were hospitalized for CDAD within 60 days of receiving outpatient antibiotic therapy . Each case patient with CDAD was matched with 10 control subjects on the basis of age , sex , and details of antibiotic use ( antibiotic class , timing , and number of antibiotics used ) . PPI use by case patients and control subjects was categorized as current ( within 90 days ) , recent ( 91 - 180 days ) , or remote ( 181 - 365 days ) . We used conditional logistic regression to estimate the odds ratio for the association between outpatient PPI use and risk of hospitalization for CDAD . RESULTS We identified 1389 case patients and 12,303 matched control subjects . Case patients were no more likely than control subjects to have received a PPI in the preceding 90 days ( adjusted odds ratio , 0.9 ; 95 % confidence interval , 0.8 - 1.1 ) . Similarly , we found no association between hospitalization for CDAD and more remote use of PPIs . CONCLUSIONS Among community-dwelling older patients , PPI use is not a risk factor for hospitalization with CDAD Background —The effect of histamine H2receptor antagonists on gastric emptying is controversial . Aims —To determine the effects of ranitidine , famotidine , and omeprazole on gastric motility and emptying . Patients and methods —Fifteen normal subjects underwent simultaneous antroduodenal manometry , electrogastrography ( EGG ) , and gastric emptying with dynamic antral scintigraphy ( DAS ) . After 30 minutes of fasting manometry and EGG recording , subjects received either intravenous saline , ranitidine , or famotidine , followed by another 30 minutes recording and then three hours of postpr and ial recording after ingestion of a radiolabelled meal . Images were obtained every 10–15 minutes for three hours to measure gastric emptying and assess antral contractility . Similar testing was performed after omeprazole 20 mg daily for one week . Results —Fasting antral phase III migrating motor complexes ( MMCs ) were more common after ranitidine ( 9/15 subjects , 60 % ) , famotidine ( 12/15 , 80 % ) , and omeprazole ( 8/12 , 67 % ) compared with placebo ( 4/14 , 29 % ; p<0.05 ) . Postpr and ially , ranitidine , famotidine , and omeprazole slowed gastric emptying , increased the amplitude of DAS contractions , increased the EGG power , and increased the antral manometric motility index . Conclusions —Suppression of gastric acid secretion with therapeutic doses of gastric acid suppressants is associated with delayed gastric emptying but increased antral motility The acid environment of the stomach serves as an important defense against intestinal colonization by potentially pathogenic bacteria . The purpose of this study was to examine the effect of increased gastric pH on bacterial translocation in a neonatal rabbit model . Fifty-nine rabbit pups were delivered by cesarean section and r and omly divided into normal acid ( NA ) and reduced acid ( RA ) groups . All were gavage fed and challenged with Enterobacter cloacae , 1 x 10(6 ) CFU/mL. The RA group received ranitidine , 20 mg/kg/d with all feeds . Gastric pH was measured by pH probe before and 4 hours after bacterial challenge . Mesenteric lymph node ( MLN ) , spleen , liver , midjejunum , and cecum were harvested for culture at 72 hours . Gastric pH in the RA group was significantly increased before and 4 hours after the bacterial challenge . The incidence of bacterial translocation to the MLN , spleen , and liver was significantly higher in the RA group . Log cecal and jejunal colony counts were significantly increased in the RA animals . The authors conclude that the gastric acidity is protective against intestinal colonization and translocation of potentially pathogenic bacteria in this neonatal rabbit model The extent of duodenal bacterial overgrowth during the pronounced inhibition of acid secretion that occurs with omeprazole treatment is unknown . The bacterial content of duodenal juice of patients treated with omeprazole was therefore examined in a controlled prospect i ve study . Duodenal juice was obtained under sterile conditions during diagnostic upper endoscopy . Aspirates were plated quantitatively for anaerobic and aerobic organisms . Twenty five out patients with peptic ulcer disease were investigated after a 5.7 ( 0.5 ) weeks ( mean ( SEM ) ) treatment course with 20 mg ( nine patients ) or 40 mg ( 16 patients ) . The control group consisted of 15 out patients referred for diagnostic endoscopy without prior antisecretory treatment . No patient in the control group had duodenal bacterial overgrowth . In the omeprazole group bacterial overgrowth ( > or = 10(5 ) cfu/ml ) was found in 14 ( 56 % ) patients ( p = 0.0003 ) . The number of bacteria ( log10 ) in duodenal juice in patients treated with omeprazole was distinctly higher ( median 5.7 ; range < 2 - 8.7 ) when compared with the control group ( median < 2 ; range < 2 - 5.0 ; p = 0.0004 ) . As well as orally derived bacteria , faecal type bacteria were found in seven of 14 and anaerobic bacteria in three of 14 patients . Bacterial overgrowth was similar with the two doses of omeprazole . These results indicate that duodenal bacterial overgrowth of both oral and faecal type bacteria occurs often in ambulatory patients treated with omeprazole . Further studies are needed to determine the clinical significance of these findings , particularly in high risk groups during long term treatment with omeprazole BACKGROUND The incidence and severity of Clostridium difficile infections are increasing . Acid-suppressive therapy has been suggested as a risk factor for C difficile , but this remains controversial . METHODS We conducted a pharmacoepidemiologic cohort study , performing a secondary analysis of data collected prospect ively on 101 796 discharges from a tertiary care medical center during a 5-year period . The primary exposure of interest was acid suppression therapy , classified by the most intense acid suppression therapy received ( no acid suppression , histamine(2)-receptor antagonist [ H(2)RA ] therapy , daily proton pump inhibitor [ PPI ] , and PPI more frequently than daily ) . RESULTS As the level of acid suppression increased , the risk of nosocomial C difficile infection increased , from 0.3 % ( 95 % confidence interval [ CI ] , 0.21%-0.31 % ) in patients not receiving acid suppressive therapy to 0.6 % ( 95 % CI , 0.49%-0.79 % ) in those receiving H(2)RA therapy , to 0.9 % ( 95 % CI , 0.80%-0.98 % ) in those receiving daily PPI treatment , and to 1.4 % ( 1.15%-1.71 % ) in those receiving more frequent PPI therapy . After adjustment for comorbid conditions , age , antibiotics , and propensity score-based likelihood of receipt of acid-suppression therapy , the association persisted , increasing from an odds ratio of 1 ( no acid suppression [ reference ] ) to 1.53 ( 95 % CI , 1.12 - 2.10 ) ( H(2)RA ) , to 1.74 ( 95 % CI , 1.39 - 2.18 ) ( daily PPI ) , and to 2.36 ( 95 % CI , 1.79 - 3.11 ) ( more frequent PPI ) . Similar estimates were found with a matched cohort analysis and with nested case-control techniques . CONCLUSIONS Increasing levels of pharmacologic acid suppression are associated with increased risks of nosocomial C difficile infection . This evidence of a dose-response effect provides further support for the potentially causal nature of iatrogenic acid suppression in the development of nosocomial C difficile infection In the period April-September 2005 , an outbreak of Clostridium difficile infection ( CDI ) due to PCR ribotype 027 occurred among 50 patients in a 341-bed community hospital in Harderwijk , The Netherl and s. A retrospective case-control study was performed to identify risk factors specific for CDI , using a group of patients with CDI ( n = 45 ) , a group of r and omly selected control patients without diarrhoea ( n = 90 ) , and a group of patients with non-infectious diarrhoea ( n = 109 ) . Risk factors for CDI and for non-CDI diarrhoea were identified using multiple logistic regression analysis . Independent risk factors for CDI were : age above 65 years ( OR 2.6 ; 95 % CI 1.0 - 5.7 ) , duration of hospitalization ( OR 1.04 per additional day ; 95 % CI 1.0 - 1.1 ) , and antibiotic use ( OR 12.5 ; 95 % CI 3.2 - 48.1 ) . Of the antibiotics used , cephalosporins and fluoroquinolones were identified as the major risk factors for development of CDI . The risk of developing CDI was particularly high in people receiving a combination of a cephalosporin and a fluoroquinolone ( OR 57.5 ; 95 % CI 6.8 - 483.6 ) . The main factors affecting the risk of \n Output:\n " }, { "from": "agent", "value": "RESULTS The use of PPIs increases gastric pH , encourages growth of the gut microflora , increases bacterial translocation and alters various immunomodulatory and anti-inflammatory effects .\nSevere hypochlorhydria generated by PPI use leads to bacterial colonisation and increased susceptibility to enteric bacterial infection ." } ]

[ { "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 effects of two Mediterranean diet ( MedDiet ) interventions versus a low-fat diet on incidence of diabetes . RESEARCH DESIGN AND METHODS This was a three-arm r and omized trial in 418 nondiabetic subjects aged 55–80 years recruited in one center ( PREDIMED-Reus , northeastern Spain ) of the Prevención con Dieta Mediterránea [ PREDIMED ] study , a large nutrition intervention trial for primary cardiovascular prevention in individuals at high cardiovascular risk . Participants were r and omly assigned to education on a low-fat diet ( control group ) or to one of two MedDiets , supplemented with either free virgin olive oil ( 1 liter/week ) or nuts ( 30 g/day ) . Diets were ad libitum , and no advice on physical activity was given . The main outcome was diabetes incidence diagnosed by the 2009 American Diabetes Association criteria . RESULTS After a median follow-up of 4.0 years , diabetes incidence was 10.1 % ( 95 % CI 5.1–15.1 ) , 11.0 % ( 5.9–16.1 ) , and 17.9 % ( 11.4–24.4 ) in the MedDiet with olive oil group , the MedDiet with nuts group , and the control group , respectively . Multivariable adjusted hazard ratios of diabetes were 0.49 ( 0.25–0.97 ) and 0.48 ( 0.24–0.96 ) in the MedDiet supplemented with olive oil and nuts groups , respectively , compared with the control group . When the two MedDiet groups were pooled and compared with the control group , diabetes incidence was reduced by 52 % ( 27–86 ) . In all study arms , increased adherence to the MedDiet was inversely associated with diabetes incidence . Diabetes risk reduction occurred in the absence of significant changes in body weight or physical activity . CONCLUSIONS MedDiets without calorie restriction seem to be effective in the prevention of diabetes in subjects at high cardiovascular risk Aims /hypothesisThe role of diet in the prevention of diabetes remains uncertain . The aim of this study was to investigate two different dietary aspects , i.e. adherence to the Mediterranean diet and glycaemic load ( GL ) , in relation to diabetes occurrence . Methods We analysed data from the Greek cohort of the population -based European Prospect i ve Investigation into Cancer and Nutrition ( EPIC ) . From a total of 22,295 participants , actively followed for a median of 11.34 years , 2,330 cases of incident type 2 diabetes were recorded . All participants completed a vali date d , interviewer-administered semi-quantitative food frequency question naire at enrolment . From this information , we calculated a ten point Mediterranean diet score ( MDS ) , reflecting adherence to the traditional Mediterranean diet , as well as the dietary GL . We estimated HRs and the corresponding 95 % CIs of diabetes using Cox proportional hazards regression models adjusted for potential confounders . Results A higher MDS was inversely associated with diabetes risk ( HR 0.88 [ 95 % CI 0.78 , 0.99 ] for MDS ≥6 vs MDS ≤3 ) . GL was positively associated with diabetes ( HR 1.21 [ 95 % CI 1.05 , 1.40 ] for the highest vs the lowest GL quartile ) . A significant protection of about 20 % was found for a diet with a high MDS and a low GL . Conclusions /interpretationA low GL diet that also adequately adheres to the principles of the traditional Mediterranean diet may reduce the incidence of type 2 diabetes Background Hypertension can be prevented by adopting healthy dietary patterns . Our aim was to assess the 4-year effect on blood pressure ( BP ) control of a r and omized feeding trial promoting the traditional Mediterranean dietary pattern . Methods The PREDIMED primary prevention trial is a r and omized , single-blinded , controlled trial conducted in Spanish primary healthcare centers . We recruited 7,447 men ( aged 55 to 80 years ) and women ( aged 60 to 80 years ) who had high risk for cardiovascular disease . Participants were assigned to a control group or to one of two Mediterranean diets . The control group received education on following a low-fat diet , while the groups on Mediterranean diets received nutritional education and also free foods ; either extra virgin olive oil , or nuts . Trained personnel measured participants ’ BP at baseline and once yearly during a 4-year follow-up . We used generalized estimating equations to assess the differences between groups during the follow-up . Results The percentage of participants with controlled BP increased in all three intervention groups ( P-value for within-group changes : P<0.001 ) . Participants allocated to either of the two Mediterranean diet groups had significantly lower diastolic BP than the participants in the control group ( −1.53 mmHg ( 95 % confidence interval ( CI ) −2.01 to −1.04 ) for the Mediterranean diet supplemented with extra virgin olive oil , and −0.65 mmHg ( 95 % CI -1.15 to −0.15 ) mmHg for the Mediterranean diet supplemented with nuts ) . No between-group differences in changes of systolic BP were seen . Conclusions Both the traditional Mediterranean diet and a low-fat diet exerted beneficial effects on BP and could be part of advice to patients for controlling BP . However , we found lower values of diastolic BP in the two groups promoting the Mediterranean diet with extra virgin olive oil or with nuts than in the control group . Trial registration Current Controlled Trials IS RCT BACKGROUND Adherence to the Mediterranean diet ( Med-Diet ) is associated with a reduced risk of cardiovascular disease ( CVD ) . However , the molecular mechanisms involved are not fully understood . OBJECTIVE The objective was to compare the effects of 2 Med-Diets with those of a low-fat diet on immune cell activation and soluble inflammatory biomarkers related to atherogenesis in subjects at high risk of CVD . DESIGN In a controlled study , we r and omly assigned 112 older subjects with diabetes or > or =3 CVD risk factors to 3 dietary intervention groups : Med-Diet with supplemental virgin olive oil ( VOO ) , Med-Diet with supplemental nuts , and low-fat diet . Changes from baseline in cellular and serum inflammatory biomarkers were assessed at 3 mo . RESULTS One hundred six participants ( 43 % women ; average age : 68 y ) completed the study . At 3 mo , monocyte expression of CD49d , an adhesion molecule crucial for leukocyte homing , and of CD40 , a proinflammatory lig and , decreased ( P < 0.05 ) after both Med-Diets but not after the low-fat diet . Serum interleukin-6 and soluble intercellular adhesion molecule-1 , inflammatory mediators crucial in firm adhesion of leukocytes to endothelial surfaces , decreased ( P < 0.05 ) in both Med-Diet groups . Soluble vascular cellular adhesion molecule-1 and C-reactive protein decreased only after the Med-Diet with VOO ( P < 0.05 ) , whereas interleukin-6 , soluble vascular cellular adhesion molecule-1 , and soluble intercellular adhesion molecule-1 increased ( P < 0.05 ) after the low-fat diet . CONCLUSIONS Med-Diets supplemented with VOO or nuts down-regulate cellular and circulating inflammatory biomarkers related to atherogenesis in subjects at high risk of CVD . The results support the recommendation of the Med-Diet as a useful tool against CVD & NA;The PREvención con DIeta MEDiterránea ( PREDIMED ) trial showed that Mediterranean diets ( MedDiets ) supplemented with either extravirgin olive oil or nuts reduced cardiovascular events , particularly stroke , compared with a control , lower fat diet . The mechanisms of cardiovascular protection remain unclear . We evaluated the 1-year effects of supplemented MedDiets on 24-hour ambulatory blood pressure ( BP ) , blood glucose , and lipids . R and omized , parallel- design , controlled trial was conducted in 2 PREDIMED sites . Diets were ad libitum , and no advice on increasing physical activity or reducing sodium intake was given . Participants were 235 subjects ( 56.5 % women ; mean age , 66.5 years ) at high cardiovascular risk ( 85.4 % with hypertension ) . Adjusted changes from baseline in mean systolic BP were −2.3 ( 95 % confidence interval [ CI ] , −4.0 to −0.5 ) mm Hg and −2.6 ( 95 % CI , −4.3 to −0.9 ) mm Hg in the MedDiets with olive oil and the MedDiets with nuts , respectively , and 1.7 ( 95 % CI , −0.1 to 3.5 ) mm Hg in the control group ( P<0.001 ) . Respective changes in mean diastolic BP were −1.2 ( 95 % CI , −2.2 to −0.2 ) , −1.2 ( 95 % CI , −2.2 to −0.2 ) , and 0.7 ( 95 % CI , −0.4 to 1.7 ) mm Hg ( P=0.017 ) . Daytime and nighttime BP followed similar patterns . Mean changes from baseline in fasting blood glucose were −6.1 , −4.6 , and 3.5 mg/dL ( P=0.016 ) in the MedDiets with olive oil , MedDiets with nuts , and control diet , respectively ; those of total cholesterol were −11.3 , −13.6 , and −4.4 mg/dL ( P=0.043 ) , respectively . In high-risk individuals , most with treated hypertension , MedDiets supplemented with extravirgin olive oil or nuts reduced 24-hour ambulatory BP , total cholesterol , and fasting glucose . Clinical Trial Registration —URL : http://www . clinical trials.gov . Unique identifier : IS RCT N35739639 Context Some experts attribute a low incidence of heart disease in Mediterranean countries to dietary habits . Contribution In this multicenter , 3-group trial , investigators r and omly assigned 772 adults at high risk for cardiovascular disease to a low-fat diet or to a Mediterranean diet supplemented with either virgin olive oil ( 1 L per week ) or nuts ( 30 g per day ) . After 3 months , the Mediterranean diet groups had lower mean plasma glucose level , systolic blood pressure , and total cholesterolhigh-density lipoprotein cholesterol ratio than the low-fat diet group . Caution s The Mediterranean diet groups received more nutritional education than the low-fat diet group . Implication s Mediterranean diets supplemented with olive oil or nuts may improve cardiovascular risk factors . The Editors Cardiovascular disease is the main cause of death in industrialized countries , but incidence rates have marked geographic differences . The low incidence of coronary heart disease ( CHD ) in Mediterranean countries has been partly ascribed to dietary habits ( 1 - 3 ) . Recent findings from large European cohort studies ( 4 - 6 ) suggest that a high degree of adherence to the Mediterranean diet is associated with a reduction in mortality . In small clinical studies , the Mediterranean diet or some of its components have reduced blood pressure ( 7 ) and have improved lipid profiles ( 8 , 9 ) and endothelial function ( 10 ) . Moreover , a recent cross-sectional study ( 11 ) and a 2-year feeding trial ( 12 ) have shown that adherence to the Mediterranean diet is associated with reduced markers of vascular inflammation . These beneficial effects on surrogate markers of cardiovascular risk add biological plausibility to the epidemiologic evidence that supports a protective effect of the Mediterranean diet . Olive oil , a rich source of monounsaturated fatty acids , is a main component of the Mediterranean diet . Virgin olive oil retains all the lipophilic components of the fruit , -tocopherol , and phenolic compounds with strong antioxidant and anti-inflammatory properties ( 13 , 14 ) . Tree nuts , which are also typical in the Mediterranean diet , have a favorable fatty acid profile and are a rich source of nutrients and other bioactive compounds that may beneficially influence the risk for CHD , such as fiber , phytosterols , folic acid , and antioxidants ( 15 ) . Frequent nut intake has been associated with decreased CHD rates in prospect i ve studies ( 15 ) . Walnuts differ from all other nuts through their high content of polyunsaturated fatty acids , particularly -linolenic acid , a plant n-3 fatty acid ( 16 ) , which may confer additional antiatherogenic properties ( 17 ) . Therefore , we design ed a large-scale feeding trial in high-risk participants to assess the effects of 2 Mediterranean diets , one supplemented with virgin olive oil and the other supplemented with mixed nuts , compared with a low \n Output:\n " }, { "from": "agent", "value": "The results of the PREDIMED study , a r and omized trial providing a higher level of scientific evidence than cohort studies , confirmed that the Mediterranean diet reduces the incidence of cardiovascular events .\nThis effect may be exerted by reducing blood pressure ; improving glucose metabolism , lipid profile , and lipoprotein particle characteristics ; and decreasing inflammation and oxidative stress .\nIt may also stem from a favorable interaction between diet and gene polymorphisms related to cardiovascular risk factors and events ." } ]

[ { "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 introduce a new method of external chest compression ( ECC ) , an essential part of cardiopulmonary resuscitation , using a thumb and index finger method ( TIFM ) on infants , and compares , this with two st and ard methods of the two finger method ( TFM ) and the two-thumb encircling h and s method ( TTEM ) . Sixty trained PALS ( Pediatric Advanced Life Support ) providers were r and omly assigned into three groups and provided one-rescuer ECC for a period of five continuous minutes . Results without coaching or feedback were recorded on a recording CPR simulator ( Laerdal , Inc ) . ECC was performed according to the BLS recommendations of the International Liaison Committee on Resuscitation ( ILCOR ) . The quality of ECC in the TFM group deviated considerably from guideline recommendations . The same parameters in the TTEM and new TIFM groups during this study were in accordance with the parameters recommended by the guidelines . Thus , our new TIFM technique of chest compression , in infants was shown to be better than the currently TFM , especially for achieving adequate compression depth and avoiding fatigue , and is equally as effective as the TTEM . We propose this new method ( TIFM ) should be considered as the method of choice in single rescuer situations CONTEXT The survival benefit of well-performed cardiopulmonary resuscitation ( CPR ) is well-documented , but little objective data exist regarding actual CPR quality during cardiac arrest . Recent studies have challenged the notion that CPR is uniformly performed according to established international guidelines . OBJECTIVES To measure multiple parameters of in-hospital CPR quality and to determine compliance with published American Heart Association and international guidelines . DESIGN AND SETTING A prospect i ve observational study of 67 patients who experienced in-hospital cardiac arrest at the University of Chicago Hospitals , Chicago , Ill , between December 11 , 2002 , and April 5 , 2004 . Using a monitor/defibrillator with novel additional sensing capabilities , the parameters of CPR quality including chest compression rate , compression depth , ventilation rate , and the fraction of arrest time without chest compressions ( no-flow fraction ) were recorded . MAIN OUTCOME MEASURE Adherence to American Heart Association and international CPR guidelines . RESULTS Analysis of the first 5 minutes of each resuscitation by 30-second segments revealed that chest compression rates were less than 90/min in 28.1 % of segments . Compression depth was too shallow ( defined as < 38 mm ) for 37.4 % of compressions . Ventilation rates were high , with 60.9 % of segments containing a rate of more than 20/min . Additionally , the mean ( SD ) no-flow fraction was 0.24 ( 0.18 ) . A 10-second pause each minute of arrest would yield a no-flow fraction of 0.17 . A total of 27 patients ( 40.3 % ) achieved return of spontaneous circulation and 7 ( 10.4 % ) were discharged from the hospital . CONCLUSIONS In this study of in-hospital cardiac arrest , the quality of multiple parameters of CPR was inconsistent and often did not meet published guideline recommendations , even when performed by well-trained hospital staff . The importance of high- quality CPR suggests the need for rescuer feedback and monitoring of CPR quality during resuscitation efforts AIMS To compare quality of CPR during out-of-hospital cardiac arrest with and without automated feedback . MATERIAL S AND METHODS Consecutive adult , out-of-hospital cardiac arrests of all causes were studied . One hundred and seventy-six episodes ( March 2002-October 2003 ) without feedback were compared to 108 episodes ( October 2003-September 2004 ) where automatic feedback on CPR was given . Automated verbal and visual feedback was based on measured quality with a prototype defibrillator . Quality of CPR was the main outcome measure and survival was reported as specified in the protocol . RESULTS Average compression depth increased from ( mean + /- S.D. ) 34 + /- 9 to 38 + /- 6 mm ( mean difference ( 95 % CI ) 4 ( 2 , 6 ) , P < 0.001 ) , and median percentage of compressions with adequate depth ( 38 - 51 mm ) increased from 24 % to 53 % ( P < 0.001 , Mann-Whitney U-test ) with feedback . Mean compression rate decreased from 121 + /- 18 to 109 + /- 12 min(-1 ) ( difference -12 ( -16 , -9 ) , P = 0.001 ) . There were no changes in the mean number of ventilations per minute ; 11 + /- 5 min(-1 ) versus 11 + /- 4 min(-1 ) ( difference 0 ( -1 , 1 ) , P = 0.8 ) or the fraction of time without chest compressions ; 0.48 + /- 0.18 versus 0.45 + /- 0.17 ( difference -0.03 ( -0.08 , 0.01 ) , P = 0.08 ) . With intention to treat analysis 7/241 control patients were discharged alive ( 2.9 % ) versus 5/117 with feedback ( 4.3 % ) ( OR 1.5 ( 95 % CI ; 0.8 , 3 ) , P = 0.2 ) . In a logistic regression analysis of all cases , witnessed arrest ( OR 4.2 ( 95 % CI ; 1.6 , 11 ) , P = 0.004 ) and average compression depth ( per mm increase ) ( OR 1.05 ( 95 % CI ; 1.01 , 1.09 ) , P = 0.02 ) were associated with rate of hospital admission . CONCLUSIONS Automatic feedback improved CPR quality in this prospect i ve non-r and omised study of out-of-hospital cardiac arrest . Increased compression depth was associated with increased short-term survival . TRIAL REGISTRATION Clinical Trials.gov ( NCT00138996 ) , http://www . clinical Background : The impact of high‐ quality chest compressions during CPR for the patients ' outcome is undisputed , as it is essential for maintaining vital organ perfusion . The aim of our study is to compare the quality of chest compression ( CC ) and ventilation among the two current st and ard techniques with our novel “ nTTT ” technique in infant CPR . Methods : In this r and omized crossover , manikin trial , participants performed CCs using three techniques in a r and omized sequence : st and ard two finger technique ( TFT ) ; st and ard two thumb technique ( TTHT ) , and the ‘ new two‐thumb technique ’ ( nTTT ) . The novel method of CCs in an infant consists in using two thumbs directed at the angle of 90 ° to the chest while closing the fingers of both h and s in a fist . Results : Median depth compression using the distinct chest compression techniques varied and amounted to 26 [ IQR , 25–28 ] mm for TFT , and 39 [ IQR , 39–39 ] mm for TTHT as well as for nTTT . Best percentage of fully released compressions were received using TFT ( 100[100 − 100 ] % ) , then in the case of nTTT ( 99[98–100 ] % ) , and the worst in situation where TTHT ( 18[14–19 ] % ) . was used . The fastest chest compression rate was achieved with TFT ( 134[IQR , 129–135]/min ) and the slowest when using nTTT ( 109 [ IQR , 105–111]/min ) . Conclusions : We found that our new nTTT technique 's performance , in terms of compression depth , h and s‐off time , and ventilation quality , is comparable to the current st and ards . Based on our findings of this initial manikin study , the nTTT technique is superior to TFT in many of parameters that are vital to a quality chest compression during pediatric CPR CONTEXT Out-of-hospital cardiac arrest is a major public health problem . OBJECTIVE To investigate whether the survival of patients with out-of-hospital cardiac arrest would improve with minimally interrupted cardiac resuscitation ( MICR ) , an alternate emergency medical services ( EMS ) protocol . DESIGN , SETTING , AND PATIENTS A prospect i ve study of survival-to-hospital discharge between January 1 , 2005 , and November 22 , 2007 . Patients with out-of-hospital cardiac arrests in 2 metropolitan cities in Arizona before and after MICR training of fire department emergency medical personnel were assessed . In a second analysis of protocol compliance , patients from the 2 metropolitan cities and 60 additional fire departments in Arizona who actually received MICR were compared with patients who did not receive MICR but received st and ard advanced life support . INTERVENTION Instruction for EMS personnel in MICR , an approach that includes an initial series of 200 uninterrupted chest compressions , rhythm analysis with a single shock , 200 immediate postshock chest compressions before pulse check or rhythm re analysis , early administration of epinephrine , and delayed endotracheal intubation . MAIN OUTCOME MEASURE Survival-to-hospital discharge . RESULTS Among the 886 patients in the 2 metropolitan cities , survival-to-hospital discharge increased from 1.8 % ( 4/218 ) before MICR training to 5.4 % ( 36/668 ) after MICR training ( odds ratio [ OR ] , 3.0 ; 95 % confidence interval [ CI ] , 1.1 - 8.9 ) . In the subgroup of 174 patients with witnessed cardiac arrest and ventricular fibrillation , survival increased from 4.7 % ( 2/43 ) before MICR training to 17.6 % ( 23/131 ) after MICR training ( OR , 8.6 ; 95 % CI , 1.8 - 42.0 ) . In the analysis of MICR protocol compliance involving 2460 patients with cardiac arrest , survival was significantly better among patients who received MICR than those who did not ( 9.1 % [ 60/661 ] vs 3.8 % [ 69/1799 ] ; OR , 2.7 ; 95 % CI , 1.9 - 4.1 ) , as well as patients with witnessed ventricular fibrillation ( 28.4 % [ 40/141 ] vs 11.9 % [ 46/387 ] ; OR , 3.4 ; 95 % CI , 2.0 - 5.8 ) . CONCLUSIONS Survival-to-hospital discharge of patients with out-of-hospital cardiac arrest increased after implementation of MICR as an alternate EMS protocol . These results need to be confirmed in a r and omized trial Background — Population -based data for pediatric cardiac arrest are scant and largely from urban areas . The Resuscitation Outcomes Consortium ( ROC ) Epistry – Cardiac Arrest is a population -based emergency medical services registry of out-of-hospital nontraumatic cardiac arrest ( OHCA ) . This study examined age-stratified incidence and outcomes of pediatric OHCA . We hypothesized that survival to hospital discharge is less frequent from pediatric OHCA than adult OHCA . Methods and Results — This prospect i ve population -based cohort study in 11 US and Canadian ROC sites included persons < 20 years of age who received cardiopulmonary resuscitation or defibrillation by emergency medical service providers and /or received byst and er automatic external defibrillator shock or who were pulseless but received no resuscitation by emergency medical services between December 2005 and March 2007 . Patients were stratified a priori into 3 age groups : < 1 year ( infants ; n=277 ) , 1 to 11 years ( children ; n=154 ) , and 12 to 19 years ( adolescents ; n=193 ) . The incidence of pediatric OHCA was 8.04 per 100 000 person-years ( 72.71 in infants , 3.73 in children , and 6.37 in adolescents ) versus 126.52 per 100 000 person-years for adults . Survival for all pediatric OHCA was 6.4 % ( 3.3 % for infants , 9.1 % for children , and 8.9 % for adolescents ) versus 4.5 % for adults ( P=0.03 ) . Unadjusted odds ratio for pediatric survival to discharge compared with adults was 0.71 ( 95 % confidence interval , 0.37 to 1.39 ) for infants , 2.11 ( 95 % confidence interval , 1.21 to 3.66 ) for children , and 2.04 ( 95 % confidence interval , 1.24 to 3.38 ) for adolescents . Conclusions — This study demonstrates that the incidence of OHCA in infants approaches that observed in adults but is lower among children and adolescents . Survival to discharge was more common among children and adolescents than infants or adults OBJECTIVE Infant CPR guidelines recommend two-finger chest compression with a lone rescuer and two-thumb with two rescuers . Two-thumb provides better chest compression but is perceived to be associated with increased ventilation h and s-off time . We hypothesized that lone rescuer two-thumb CPR is associated with increased ventilation cycle time , decreased ventilation quality and fewer chest compressions compared to two-finger CPR in an infant manikin model . DESIGN Crossover observational study r and om \n Output:\n " }, { "from": "agent", "value": "This study indicates that the two-thumb-encircling h and s technique is a more appropriate technique for a single rescuer to perform high- quality chest compression in consideration of chest compression depth than the two-finger technique in infant manikin studies" } ]

[ { "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 Studies with pertuzumab , a novel anti-HER2 antibody , show improved efficacy when combined with the established HER2-directed antibody trastuzumab in breast cancer therapy . We investigated the combination of pertuzumab or trastuzumab , or both , with docetaxel and the combination of pertuzumab and trastuzumab without chemotherapy in the neoadjuvant setting . METHODS In this multicentre , open-label , phase 2 study , treatment-naive women with HER2-positive breast cancer were r and omly assigned ( 1:1:1:1 ) central ly and stratified by operable , locally advanced , and inflammatory breast cancer , and by hormone receptor expression to receive four neoadjuvant cycles of : trastuzumab ( 8 mg/kg loading dose , followed by 6 mg/kg every 3 weeks ) plus docetaxel ( 75 mg/m(2 ) , escalating , if tolerated , to 100 mg/m(2 ) every 3 weeks ; group A ) or pertuzumab ( loading dose 840 mg , followed by 420 mg every 3 weeks ) and trastuzumab plus docetaxel ( group B ) or pertuzumab and trastuzumab ( group C ) or pertuzumab plus docetaxel ( group D ) . The primary endpoint , examined in the intention-to-treat population , was pathological complete response in the breast . Neither patients nor investigators were masked to treatment . This study is registered with Clinical Trials.gov , number NCT00545688 . FINDINGS Of 417 eligible patients , 107 were r and omly assigned to group A , 107 to group B , 107 to group C , and 96 to group D. Patients given pertuzumab and trastuzumab plus docetaxel ( group B ) had a significantly improved pathological complete response rate ( 49 of 107 patients ; 45·8 % [ 95 % CI 36·1 - 55·7 ] ) compared with those given trastuzumab plus docetaxel ( group A ; 31 of 107 ; 29·0 % [ 20·6 - 38·5 ] ; p=0·0141 ) . 23 of 96 ( 24·0 % [ 15·8 - 33·7 ] ) women given pertuzumab plus docetaxel ( group D ) had a pathological complete response , as did 18 of 107 ( 16·8 % [ 10·3 - 25·3 ] ) given pertuzumab and trastuzumab ( group C ) . The most common adverse events of grade 3 or higher were neutropenia ( 61 of 107 women in group A , 48 of 107 in group B , one of 108 in group C , and 52 of 94 in group D ) , febrile neutropenia ( eight , nine , none , and seven , respectively ) , and leucopenia ( 13 , five , none , and seven , respectively ) . The number of serious adverse events was similar in groups A , B , and D ( 15 - 20 serious adverse events per group in 10 - 17 % of patients ) but lower in group C ( four serious adverse events in 4 % of patients ) . INTERPRETATION Patients given pertuzumab and trastuzumab plus docetaxel ( group B ) had a significantly improved pathological complete response rate compared with those given trastuzumab plus docetaxel , without substantial differences in tolerability . Pertuzumab and trastuzumab without chemotherapy eradicated tumours in a proportion of women and showed a favourable safety profile . These findings justify further exploration in adjuvant trials and support the neoadjuvant approach for accelerating drug assessment in early breast cancer . FUNDING F Hoffmann-La Roche BACKGROUND We studied the effect on tumour response to neoadjuvant therapy of the substitution of lapatinib for trastuzumab in combination with weekly paclitaxel after doxorubicin plus cyclophosphamide treatment , and of the addition of lapatinib and trastuzumab combined after doxorubicin plus cyclophosphamide treatment in patients with HER2-positive operable breast cancer to determine whether there would be a benefit of dual HER2 blockade in these patients . METHODS For this open-label , r and omised phase 3 trial we recruited women aged 18 years or older with an ECOG performance status of 0 or 1 with operable HER2-positive breast cancer . Each received four cycles of st and ard doxorubicin 60 mg/m(2 ) and cyclophosphamide 600 mg/m(2 ) intravenously on day 1 every 3 weeks followed by four cycles of weekly paclitaxel ( 80 mg/m(2 ) ) intravenously on days 1 , 8 , and 15 , every 4 weeks . Concurrently with weekly paclitaxel , patients received either trastuzumab ( 4 mg/kg load , then 2 mg/kg intravenously ) weekly until surgery , lapatinib ( 1250 mg orally ) daily until surgery , or weekly trastuzumab plus lapatinib ( 750 mg orally ) daily until surgery . After surgery , all patients received trastuzumab to complete 52 weeks of HER2-targeted therapy . R and omisation ( ratio 1:1:1 ) was done central ly with stratification by clinical tumour size , clinical nodal status , hormone-receptor status , and age . The primary endpoint was the pathological complete response in the breast , and analysis was performed on an intention-to-treat population . FINDINGS Patient accrual started on July 16 , 2007 , and was completed on June 30 , 2011 ; 529 women were enrolled in the trial . 519 patients had their pathological response determined . Breast pathological complete response was noted in 93 ( 52·5 % , 95 % CI 44·9 - 59·5 ) of 177 patients in the trastuzumab group , 91 ( 53·2 % , 45·4 - 60·3 ) of 171 patients in the lapatinib group ( p=0·9852 ) ; and 106 ( 62·0 % , 54·3 - 68·8 ) of 171 patients in the combination group ( p=0·095 ) . The most common grade 3 and 4 toxic effects were neutropenia ( 29 [ 16 % ] patients in the trastuzumab group [ grade 4 in five patients ( 3 % ) , 28 [ 16 % ] in the lapatinib group [ grade 4 in eight patients ( 5 % ) ] , and 29 [ 17 % ] in the combination group [ grade 4 in nine patients ( 5 % ) ] ) and grade 3 diarrhoea ( four [ 2 % ] patients in the trastuzumab group , 35 [ 20 % ] in the lapatinib group , and 46 [ 27 % ] in the combination group ; p<0·0001 ) . Symptomatic congestive heart failure defined as New York Heart Association Class III or IV events occurred in seven ( 4 % ) patients in the trastuzumab group , seven ( 4 % ) in the lapatinib group , and one ( < 1 % ) in the combination group ; p=0·185 ) . INTERPRETATION Substitution of lapatinib for trastuzumab in combination with chemotherapy result ed in similar high percentages of pathological complete response . Combined HER2-targeted therapy produced a numerically but insignificantly higher pathological complete response percentage than single-agent HER2-directed therapy ; these findings are consistent with results from other studies . Trials are being undertaken to further assess these findings in the adjuvant setting Overexpression of human epidermal growth factor receptor-2 ( HER2 ) in metastatic breast cancer ( MBC ) is associated with poor prognosis . This single-arm open-label trial ( EGF109491 ; NCT00508274 ) was design ed to confirm the efficacy and safety of lapatinib in combination with capecitabine in 52 heavily pretreated Chinese patients with HER2-positive MBC . The primary endpoint was clinical benefit rate ( CBR ) . Secondary endpoints included progression-free survival ( PFS ) , time to response ( TTR ) , duration of response ( DoR ) , central nervous system ( CNS ) as first site of relapse , and safety . The results showed that there were 23 patients with partial responses and 7 patients with stable disease , result ing in a CBR of 57.7 % . The median PFS was 6.34 months ( 95 % confidence interval , 4.93–9.82 months ) . The median TTR and DoR were 4.07 months ( range , 0.03–14.78 months ) and 6.93 months ( range , 1.45–9.72 months ) , respectively . Thirteen ( 25.0 % ) patients had new lesions as disease progression . Among them , 2 ( 3.8 % ) patients had CNS disease reported as the first relapse . The most common toxicities were palmar-plantar erythrodysesthesia ( 59.6 % ) , diarrhea ( 48.1 % ) , rash ( 48.1 % ) , hyperbilirubinemia ( 34.6 % ) , and fatigue ( 30.8 % ) . Exploratory analyses of oncogenic mutations of PIK3CA suggested that of 38 patients providing a tumor sample , baseline PIK3CA mutation status was not associated with CBR ( P = 0.639 ) or PFS ( P = 0.989 ) . These data confirm that the lapatinib plus capecitabine combination is an effective and well-tolerated treatment option for Chinese women with heavily pretreated MBC , irrespective of PIK3CA status BACKGROUND The anti-HER2 monoclonal antibody trastuzumab and the tyrosine kinase inhibitor lapatinib have complementary mechanisms of action and synergistic antitumour activity in models of HER2-overexpressing breast cancer . We argue that the two anti-HER2 agents given together would be better than single-agent therapy . METHODS In this parallel groups , r and omised , open-label , phase 3 study undertaken between Jan 5 , 2008 , and May 27 , 2010 , women from 23 countries with HER2-positive primary breast cancer with tumours greater than 2 cm in diameter were r and omly assigned to oral lapatinib ( 1500 mg ) , intravenous trastuzumab ( loading dose 4 mg/kg [ DOSAGE ERROR CORRECTED ] , subsequent doses 2 mg/kg ) , or lapatinib ( 1000 mg ) plus trastuzumab . Treatment allocation was by stratified , permuted blocks r and omisation , with four stratification factors . Anti-HER2 therapy alone was given for the first 6 weeks ; weekly paclitaxel ( 80 mg/m(2 ) ) was then added to the regimen for a further 12 weeks , before definitive surgery was undertaken . After surgery , patients received adjuvant chemotherapy followed by the same targeted therapy as in the neoadjuvant phase to 52 weeks . The primary endpoint was the rate of pathological complete response ( pCR ) , analysed by intention to treat . This trial is registered with Clinical Trials.gov , NCT00553358 . FINDINGS 154 patients received lapatinib , 149 trastuzumab , and 152 the combination . pCR rate was significantly higher in the group given lapatinib and trastuzumab ( 78 of 152 patients [ 51·3 % ; 95 % CI 43·1 - 59·5 ] ) than in the group given trastuzumab alone ( 44 of 149 patients [ 29·5 % ; 22·4 - 37·5 ] ; difference 21·1 % , 9·1 - 34·2 , p=0·0001 ) . We recorded no significant difference in pCR between the lapatinib ( 38 of 154 patients [ 24·7 % , 18·1 - 32·3 ] ) and the trastuzumab ( difference -4·8 % , -17·6 to 8·2 , p=0·34 ) groups . No major cardiac dysfunctions occurred . Frequency of grade 3 diarrhoea was higher with lapatinib ( 36 patients [ 23·4 % ] ) and lapatinib plus trastuzumab ( 32 [ 21·1 % ] ) than with trastuzumab ( three [ 2·0 % ] ) . Similarly , grade 3 liver-enzyme alterations were more frequent with lapatinib ( 27 [ 17·5 % ] ) and lapatinib plus trastuzumab ( 15 [ 9·9 % ] ) than with trastuzumab ( 11 [ 7·4 % ] ) . INTERPRETATION Dual inhibition of HER2 might be a valid approach to treatment of HER2-positive breast cancer in the neoadjuvant setting . FUNDING GlaxoSmithKline PURPOSE This is a noncomparative , r and omized , phase II trial of preoperative taxane-anthracycline in combination with trastuzumab , lapatinib , or combined trastuzumab plus lapatinib in patients with human epidermal growth factor receptor 2 ( HER2 ) -positive , stage II to IIIA operable breast cancer . The primary aim was to estimate the percentage of pathologic \n Output:\n " }, { "from": "agent", "value": "Subgroup analyses indicated that the addition of chemotherapy to dual anti-HER2 therapy could greatly improve pCR in the neoadjuvant setting s. However , in the metastatic setting , similar PFS and OS were found in patients receiving dual anti-HER2 therapy with or without chemotherapy .\nDual anti-HER2 therapy was associated with more frequent adverse events than monotherapy , but no statistical differences were observed in cardiac toxicity .\nConclusions This systematic review provides a summary of all the data currently available , and confirms the benefits and risks of dual anti-HER2 therapy for HER2-positive breast 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: The frequency of the 235 T and 174 M alleles of the angiotensinogen gene , previously reported to be associated with hypertension in Caucasians and Japanese , was compared between 57 hypertensive African Americans and 130 normotensive African Americans sample d as part of a community survey of hypertension in the Chicago area . The frequency of the 235 T allele was unrelated to hypertension status ( cases , 83 % , control subjects , 82 % ) , as was true for the 174 M allele . Compared with Caucasians , the frequency of the 235 T allele was twice as high in this African American population , while the frequency of the 174 M allele was similar . Even higher frequencies of the 235 T allele ( 93 % ) were noted in a sample of 122 Nigerians . It appears that the 235 T allele is very common in population s of West African origin , although we found no evidence that it confers risk of hypertension Abstract —The genes of the renin-angiotensin system have been subjected to intense molecular scrutiny in cardiovascular disease studies , but their contribution to risk is still uncertain . In this study , we sample d 192 African American and 153 European American families ( 602 and 608 individuals , respectively ) to evaluate the contribution of variations in genes that encode renin-angiotensin system components of susceptibility to hypertension . We genotyped 25 single-nucleotide polymorphisms in the renin-angiotensin system genes ACE , AGT , AGTR1 , and REN . The family-based transmission/disequilibrium test was performed with each single-nucleotide polymorphism and with the multilocus haplotypes . Two individual single-nucleotide polymorphisms were significantly associated with hypertension among African Americans , and this result persisted when both groups were combined . The associations were confirmed in haplotype analysis for REN , AGTR1 , and ACE in African Americans . Consistent but less significant evidence was found in European Americans . We also r and omly sample d unrelated individuals across families to obtain 84 cases and 108 controls among the African Americans and 41 cases and 113 controls in the European Americans . Single-nucleotide polymorphism and haplotype analyses again showed consistent , albeit weaker , results . Thus , in this biracial population sample , we find evidence that interindividual variation in the renin-angiotensin system genes contributes to hypertension risk BACKGROUND The angiotensin II type 1 receptor A1166C polymorphism has been associated with increased risks of hypertension and myocardial infa rct ion in several small studies . We examined the association between this polymorphism and new-onset hypertension , blood pressure ( BP ) control , and incident cardiovascular events in a large population -based cohort of older adults . METHODS Eight hundred self-identified African Americans and 1,371 r and omly selected white participants in the Cardiovascular Health Study were genotyped . The median duration of follow-up was 8.1 years . RESULTS The A1166C polymorphism was not associated with new-onset hypertension , with BP control , or with incident cardiovascular events in the overall population . In white participants , the CC genotype was associated with higher baseline systolic BP and pulse pressure , compared to the AC or AA genotype . In whites with treated hypertension at baseline , compared to the AA genotype , the CC genotype was associated with increased risks of incident congestive heart failure ( hazard ratio = 2.5 , 95 % confidence interval [ CI ] 1.3 - 4.9 ) and incident ischemic stroke ( hazard ratio = 2.6 , 95 % CI 1.1 - 6.0 ) . These associations were not observed among white participants without treated hypertension , but the interaction of genotype with treated hypertension on ischemic stroke and heart failure was only marginally significant . CONCLUSIONS On the whole , in this large cohort of older adults , the A1166C polymorphism was not associated with BP control or incident cardiovascular events . The subgroup findings in treated hypertensives need to be confirmed in additional studies \n Output:\n " }, { "from": "agent", "value": "Concordance between these two population s was found for some SNPs ." } ]

[ { "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: Both menstrual phase and nicotine have been shown to affect task performance . Though conflicting results have been reported , at least one well-controlled study has demonstrated that women at midluteal phase show superior performance on speech articulation and speeded motor coordination tests , but poorer performance on perceptual-spatial tests , than during menses . Smokers have demonstrated superior performance on numerous tasks following nicotine than following placebo . To explore the separate and combined influence of these factors , we studied 13 regularly-menstruating smokers using a two ( smoking vs. 12 hours ' abstinence ) by two ( menstrual vs. midluteal phase ) factorial design . During each session , subjects completed a test battery including two speeded motor coordination tasks , a computerized reaction time test , and the Stroop ( 1935 ) color/word test . Subjects completed the Stroop color and color-word tasks significantly faster after ad lib smoking than after overnight abstinence . No other significant differences emerged . Our findings replicate , in an all-female sample , previous reports that speed of cognitive processing is reduced by nicotine abstinence ( or enhanced by nicotine administration ) . Our failure to observe menstrual cycle effects raises the possibility that the anti-estrogenic effects of smoking may attenuate phase differences in performance Much research has shown that individuals exhibit an attentional bias to stimuli related to their current concerns or pathologies . Using the emotional Stroop task , we investigated attentional bias in smokers . Ninety-six smokers either abstained from smoking for 24 hr or smoked normally before color-naming smoking-related and neutral words . Both a blocked format ( smoking and neutral words presented in separate blocks ) and an unblocked format ( smoking and neutral words presented in a mixed r and om sequence ) were used . In the blocked format , abstinence caused an attentional bias to smoking-related stimuli , and the degree of attentional bias predicted the latency to the first cigarette of the morning . However , different results were obtained from the unblocked version of the task . We conclude that the emotional Stroop task is a useful tool to measure attentional bias in smokers and could be used in cessation studies The emotional Stroop task was used to examine the influence of opportunity to smoke on attentional bias to smoking-related stimuli . At the outset of the study , 92 nicotine-deprived smokers were told that they ( a ) would , ( b ) would not , or ( c ) might be able to smoke during the experiment . Next , participants completed an emotional Stroop task , in which they were presented with smoking-related or -unrelated words in an unblocked format . Smokers demonstrated interference to the smoking words , relative to matched neutral words , F(1 , 87 ) = 18.0 , p < .0001 . Moreover , smoking opportunity affected the degree of interference , F(2 , 87 ) = 4.35 , p < .02 , with participants who had been told they would be able to smoke during the study showing the most interference . The results suggest that smoking opportunity affects the salience of smoking-related stimuli among nicotine-deprived smokers Recent theories of addiction suggest that an attentional bias for drug-related cues plays an important role in maintaining drug-taking behaviours . A key feature of the present study is that it used three different meas ures of processing bias for linguistic and pictorial smoking-related cues : masked and unmasked conditions of the modified Stroop task , and a pictorial version of the visual probe task . Participants were smokers ( n= 27 ) , who were tested twice , with deprivation level manipulated as a within-subjects variable . They were asked to abstain from smoking for 12 h before one session , and to smoke normally before the other . Results were consistent with an attentional bias for smoking-related pictures on the visual probe task , and for smoking-related words in the unmasked condition of the modified Stroop task . The latter bias was most strongly predicted by self-reported urge to smoke , rather than by the deprivation manipulation . There was no evidence of a preconscious bias for smoking cues . The three measures of cognitive bias ( from masked and unmasked Stroop and visual probe tasks ) were not significantly correlated with each other , which suggests they may tap different underlying mechanisms . We discuss the results with respect to conceptualizations ofselective attention , addiction and motivational states in general As many as one-half of smokers relapse in the first week following a quit attempt , and subjective reports of cognitive deficits in early abstinence are associated with increased relapse risk . This study examined whether objective cognitive performance after 3 days of abstinence predicts smoking resumption in a 7-day simulated quit attempt . Sixty-seven treatment-seeking smokers received either varenicline or placebo ( r and omized double-blind ) for 21 days . Following medication run-up ( days 1 - 10 ) , there was a 3-day m and atory ( biochemically confirmed ) abstinence period ( days 11 - 13 ) during which working memory ( Letter-N-Back Task ) and sustained attention ( Continuous Performance Task ) were assessed ( day 13 ) . Participants were then exposed to a scheduled smoking lapse and instructed to try to remain abstinent for the next 7 days ( days 15 - 21 ) . Poorer cognitive performance ( slower correct reaction time on Letter-N-Back task ) during abstinence predicted more rapid smoking resumption among those receiving placebo ( p=0.038 ) but not among those receiving varenicline . These data lend further support for the growing recognition that cognitive deficits involving working memory are a core symptom of nicotine withdrawal and a potential target for the development of pharmacological and behavioral treatments Rationale Attentional biases and executive control deficits may play a role in smoking cessation failure . Objectives The object of this study was to determine whether smokers ' pre-quit reaction times on a computerized modified Simon task ( which assesses attentional biases and executive control deficits ) predict abstinence following a quit attempt . Methods Participants ( N = 365 ) in a larger smoking cessation clinical trial completed the modified Simon task twice ( while 10-h nicotine-deprived vs. not deprived ) . In the task , two photographs ( i.e. , two digital slides ) were displayed — one always neutral , the other positive , negative , smoking-relevant , or neutral . A probe ( < < < or > > > ) then appeared to the left or right of center , and participants indicated the arrow 's direction ( left or right ) which was either congruent or incongruent with the arrow 's location on the screen . The incongruency effect , a measure of executive control , was calculated by subtracting the reaction time to congruent probes from the reaction time to incongruent probes . Results Greater impairment in executive control ( i.e. , greater probe incongruency effects ) after viewing positive and smoking slides relative to negative slides predicted an inability to establish initial cessation and to maintain abstinence up to 8 weeks post-quit . Conclusions These effects may be because smokers who avoid/escape from processing negative affect are more likely to fail in a cessation attempt . Differences in relatively automatic responses to affective cues distinguish smokers who are successful and unsuccessful in their smoking cessation attempts , but effects were modest in size The discovery of the role of nicotinic receptors in attention and memory has led to the testing of nicotinic analogs as cognitive enhancing agents in patient population s. Empirical information about nicotine 's ability to enhance elements of attention and memory in normal individuals might guide development of therapeutic uses of nicotine in cognitively impaired population s. The purpose of this study was to determine the effect of nicotine on continuous attention , working memory , and computational processing in tobacco-deprived and nondeprived smokers . A total of 28 smokers ( 14 men , 14 women ) participated in a double-blind , placebo-controlled , within-subject study , in which they were overnight ( 12 h ) tobacco deprived at one session and smoked ad libitum before the other session . At each session , participants received 0 , 1 , and 2 mg nicotine via nasal spray in r and om order at 90 min intervals . Before and after each dose , a battery of cognitive , subjective , and physiological measures was administered , and blood sample s were taken for plasma nicotine concentration . Overnight tobacco deprivation result ed in impaired functioning on all cognitive tests and increased self-reports of tobacco craving and negative mood ; nicotine normalized these deficits . In the nondeprived condition , nicotine enhanced performance on the continuous performance test ( CPT ) and an arithmetic test in a dose-related manner , but had no effect on working memory . In general , women were more sensitive than men to the subjective effects of nicotine . These results provide an unequivocal determination that nicotine enhanced attentional and computational abilities in nondeprived smokers and suggest these cognitive domains as substrates for novel therapeutic indications INTRODUCTION A significant percentage of smokers attempting cessation lapse to smoking within a matter of days , and current models of relapse devote insufficient attention to such early smoking lapse . Studies attempting to relate severity of nicotine withdrawal symptoms to short-term smoking cessation outcomes have yielded equivocal results . How one reacts to the discomfort of nicotine withdrawal and quitting smoking ( i.e. , distress tolerance ) may be a more promising avenue of investigation with important treatment implication s. METHODS The present investigation examined distress tolerance and early smoking lapse using a prospect i ve design . Participants were 81 adult daily smokers recruited through newspaper advertisements targeted at smokers planning to quit smoking without assistance ( i.e. , no pharmacotherapy or psychosocial treatment ; 42 males and 39 females ; mean age = 42.6 years , SD = 12.20 ) . RESULTS As hypothesized , both greater breath-holding duration and carbon dioxide-enriched air persistence were associated with a significantly lower risk of smoking lapse following an unaided quit attempt . These effects were above and beyond the risk associated with levels of nicotine dependence , education , and history of major depressive disorder , suggesting that distress tolerance and task persistence may operate independently of risk factors such as nicotine dependence and depressive history . In contrast to expectation , persistence on the Paced Auditory Serial Addition Test ( a psychological challenge task ) was not a significant predictor of earlier smoking lapse . DISCUSSION These results are discussed in relation to refining theoretical models of the role of distress tolerance in early smoking lapse and the utility of such models in the development of specialized treatment approaches for smoking cessation Rationale Smokers report enhanced concentration after cigarette smoking and difficulty concentrating when abstinent from smoking . These perceived effects may contribute to smoking cessation failures , and if so , clarification of their cognitive bases could inform treatment strategies . Selective attention may be important in this regard , but earlier literature presents inconsistent findings on how smoking abstinence and resumption of smoking influence this cognitive function . Objectives We aim ed to compare smokers and nonsmokers on selective attention , and in smokers , to test the effects of overnight abstinence from smoking and of acute smoking on selective attention . Material s and methods Smokers and nonsmokers ( n = 43 ) performed a Stroop test ( two test days , two test blocks per day ) . Smokers participated after overnight abstinence and also within 1-h of ad libitum smoking . Smokers each smoked a cigarette between test blocks on each day ; nonsmokers did not . Results Smokers demonstrated longer response latencies for both congruent and incongruent stimuli after overnight than brief abstinence , but no deficit specifically related to selective attention . Whereas nonsmokers showed no changes in performance in the second test block , smoking between blocks reduced the Stroop effect when smokers were abstinent overnight . Conclusions These data are consistent with the hypothesis that abstinence from smoking among nicotine-dependent individuals has deleterious effects on cognitive performance , but do not indicate that selective attention is adversely effected . Improvement in selective attention after terminating abstinence with one cigarette may also contribute to smokers ’ perceived enhanced ability to concentrate after smoking The aim of this study was to investigate selective processing biases towards smoking-related stimuli in relation to acute abstinence and smoking history . Differences in the processing of smoking-related and control cues in current smokers , ex-smokers and never-smokers on the modified Stroop task were investigated , with smokers r and omized to either abstain or smoke normally for a period of 24 h. The results indicated no significant effect of deprivation ( abstinent versus non-abstinent smokers ) , or of smoking history ( ex- versus never-smokers ) on colour-naming times for smoking-related versus control words . However , there was a significant effect of smoking status ( current versus non-smokers ) on colour-naming times for smoking words compared to control words ( i.e. slower colour-naming of smoking-related words in smokers ) . This effect approached significance when stimuli were presented in a masked exposure condition . Among smokers , colour-naming interference was associated with the personality trait of Sensitivity to Reward . These results indicate a processing bias for smoking-related cues in current smokers . However , this bias does not appear to be a permanent feature of nicotine addiction , given the lack of difference between ex-smokers and never-smokers Smokers ( n = 315 ) who wished to quit were r and omly assigned in a double-blind manner to groups using either nicotine or placebo gum . Self-reported and observed symptoms of tobacco withdrawal were collected before cessation and at follow-ups of 1 to 2 weeks , 1 month , and 6 months . Self-reported and /or observed anger , anxiety , craving , difficulty concentr \n Output:\n " }, { "from": "agent", "value": "Compared with satiated smokers , acutely abstinent smokers display higher delay discounting , lower response inhibition , impaired arithmetic and recognition memory performance .\nHowever , reaction-time measures of cognitive bias appear to be unaffected by acute tobacco abstinence ." } ]

[ { "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 examine the relationship of diabetes mellitus to depression , cognition , and structural brain anatomical variables in a 60 - 64-year-old community-dwelling sample . The authors hypothesized that subjects with Type 2 diabetes are more likely to be depressed , have more brain atrophy , and poorer cognitive function compared with nondiabetic comparison subjects . METHODS A r and om sample of 478 subjects aged 60 - 64 years from a larger community sample were interviewed and underwent physical examinations , assessment of depression , st and ard cognitive assessment s , brain magnetic resonance imaging ( MRI ) scans , and fasting blood tests . Subjects were considered diabetic if they were on treatment for diabetes or recorded a fasting blood glucose level of greater than 10 mmol/L. The MRI scans were analyzed for brain atrophy , gray matter ( GM ) , white matter ( WM ) , cerebrospinal fluid ( CSF ) , hippocampal , and white matter hyperintensity ( WMH ) volumes . RESULTS MRI data were available for 39 subjects with diabetes and 428 subjects without diabetes . Descriptive analyses showed that subjects with diabetes were more likely to have poor physical health , a higher body mass index , and higher scores of depression and anxiety compared with comparison subjects without diabetes . In multiple regression analyses , diabetes was associated with greater total brain atrophy and larger CSF volume , but did not differ in the WM , GM , and WMH volumes . Diabetes patients performed less well on a task of fine motor dexterity . CONCLUSIONS Diabetes is related to increased brain atrophy and poor motor function in 60 - 64 year olds , independent of depression , vascular risk factors , and small vessel disease of the brain AIM To assess whether an intensive multifactorial treatment can reduce cognitive decrements and cognitive decline in screen-detected type 2 diabetes . METHODS The multinational ADDITION- study , a cluster-r and omized parallel group trial in patients with screen-detected type 2 diabetes , compared the effectiveness of intensive multifactorial treatment ( IT ; lifestyle advice and strict regulation of metabolic parameters ) with routine care ( RC ) on cardiovascular outcome . In The Netherl and s r and omization was stratified according to practice organization . Allocation was concealed from patients . The present study assessed the effect of IT on cognition through two neuropsychological assessment s ( NPA ) on two occasions . The assessment s took place three and six years after the start of the intervention . Non-diabetic controls served as reference group . The first NPA was performed in 183 patients ( IT : 97 ; RC : 86 ) and 69 controls . The second NPA was performed in 135 patients ( IT : 71 ; RC : 64 ) and 55 controls . Primary outcome was a composite score , including the domains memory , information-processing speed and attention and executive function . Comparisons between the treatment groups were performed with multi-level analyses . RESULTS The first NPA showed no differences between the treatment groups ( mean difference composite z-score : 0.00 ; 95%-CI -0.16 to 0.16 ; IT vs RC ) . Over the next three years cognitive decline in the diabetic groups was within the range of the reference group and did not differ between the treatment arms ( difference decline between diabetic groups -0.12 ; -0.24 to 0.01 ; IT vs RC ) . CONCLUSIONS Six years of IT in screen-detected type 2 diabetes had no benefit on cognitive functioning over RC BACKGROUND Few prospect i ve studies have assessed diabetes mellitus as a risk factor for incident Alzheimer disease ( AD ) and decline in cognitive function . OBJECTIVE To evaluate the association of diabetes mellitus with risk of AD and change in different cognitive systems . DESIGN Longitudinal cohort study . PARTICIPANTS For up to 9 years , 824 older ( those > 55 years ) Catholic nuns , priests , and brothers underwent detailed annual clinical evaluations . MAIN OUTCOME MEASURES Clinical ly diagnosed AD and change in global and specific measures of cognitive function . RESULTS Diabetes mellitus was present in 127 ( 15.4 % ) of the participants . During a mean of 5.5 years of observation , 151 persons developed AD . In a proportional hazards model adjusted for age , sex , and educational level , those with diabetes mellitus had a 65 % increase in the risk of developing AD compared with those without diabetes mellitus ( hazard ratio , 1.65 ; 95 % confidence interval , 1.10 - 2.47 ) . In r and om effects models , diabetes mellitus was associated with lower levels of global cognition , episodic memory , semantic memory , working memory , and visuospatial ability at baseline . Diabetes mellitus was associated with a 44 % greater rate of decline in perceptual speed ( P = .02 ) , but not in other cognitive systems . CONCLUSIONS Diabetes mellitus may be associated with an increased risk of developing AD and may affect cognitive systems differentially BACKGROUND The long-term effect of type 2 diabetes on cognitive function is uncertain . OBJECTIVE To determine whether older women with diabetes have an increased risk of cognitive impairment and cognitive decline . DESIGN Prospect i ve cohort study . SETTING Four research centers in the United States ( Baltimore , Md ; Portl and , Ore ; Minneapolis , Minn ; and the Monongahela Valley , Pennsylvania ) . PARTICIPANTS Community-dwelling white women 65 years and older ( n = 9679 ) . MEASUREMENTS Physician-diagnosed diabetes and other aspects of health history were assessed by interview . Three tests of cognitive function , the Digit Symbol test , the Trails B test , and a modified version of the Mini-Mental State Examination ( m-MMSE ) , were administered at baseline and 3 to 6 years later . Change in cognitive function was defined by the change in the score for each test . Major cognitive decline was defined as the worst 10th percentile change in the score for each test . RESULTS Women with diabetes ( n = 682 [ 7.0 % ] ) had lower baseline scores than those without diabetes on all 3 tests of cognitive function ( Digit Symbol and Trials B tests , P<.01 ; m-MMSE , P = .03 ) and experienced an accelerated cognitive decline as measured by the Digit Symbol test ( P<.01 ) and m-MMSE ( P = .03 ) . Diabetes was also associated with increased odds of major cognitive decline as determined by scores on the Digit Symbol ( odds ratio = 1.63 ; 95 % confidence interval , 1.20 - 2.23 ) and Trails B ( odds ratio , 1.74 ; 95 % confidence interval , 1.27 - 2.39 ) tests when controlled for age , education , depression , stroke , visual impairment , heart disease , hypertension , physical activity , estrogen use , and smoking . Women who had diabetes for more than 15 years had a 57 % to 114 % greater risk of major cognitive decline than women without diabetes . CONCLUSION Diabetes is associated with lower levels of cognitive function and greater cognitive decline among older women Objective : To determine the influence of type 2 diabetes mellitus on the risk of dementia and AD . Background : Both dementia and diabetes are frequent disorders in elderly people . Methods : Prospect i ve population -based cohort study among 6,370 elderly subjects . At baseline study participants were examined for presence of diabetes mellitus . Nondemented participants were followed up , on average , for 2.1 years . Incident dementia was diagnosed using a three-step screening and comprehensive diagnostic workup . To complete the follow-up , medical files were studied of persons who could not be reexamined . We estimated relative risks with proportional hazard regression , adjusting for age , sex , and possible confounders . Results : During the follow-up , 126 patients became demented , of whom 89 had AD . Diabetes mellitus almost doubled the risk of dementia ( relative risk [ RR ] 1.9 [ 1.3 to 2.8 ] ) and AD ( RR 1.9 [ 1.2 to 3.1 ] ) . Patients treated with insulin were at highest risk of dementia ( RR 4.3 [ 1.7 to 10.5 ] ) . Conclusion : The diabetes attributable risk for dementia of 8.8 % suggests that diabetes may have contributed to the clinical syndrome in a substantial proportion of all dementia patients OBJECTIVES To relate diabetes mellitus ( DM ) status and duration to late-life cognitive impairment and decline in men and women . DESIGN Prospect i ve cohort . SETTING Community . PARTICIPANTS Five thous and nine hundred seven men in the Physicians ' Health Study II and 6,326 women in the Women 's Health Study ( mean age 74.1 and 71.9 , respectively , at baseline cognitive assessment ) ; 553 men and 405 women had DM . MEASUREMENTS Primary outcomes were general cognition ( the Telephone Interview for Cognitive Status ( TICS ) and a global score averaging five tests ) and verbal memory . All participants had second assessment s approximately 2 years later ; women had third assessment s an average of 4 years later . RESULTS In adjusted linear regression models , participants with DM had significantly lower baseline scores for all outcomes , and longer duration of DM was associated with lower scores ( P-trends < .001 ) . Men with DM had significantly greater 2-year cognitive decline than men without DM , and longer duration of DM was associated with worse decline ( P-trends < or = .01 ) . In repeated- measures analyses of response profiles , women with DM had significantly greater 4-year cognitive decline in all outcomes than women without DM . In women , as in men , there was generally greater cognitive decline with longer duration of DM ( e.g. , the adjusted mean difference in decline on the TICS associated with duration of > or = 5 years was -0.74 ( 95 % confidence interval = -1.05 to -0.43 ) points ( P-trend < .001 ) . There were no significant sex-DM interactions . CONCLUSION Type 2 DM and longer duration of DM are similarly related to cognitive impairment and decline in men and women \n Output:\n " }, { "from": "agent", "value": "We found no difference in the sub-domains of verbal short-term memory and working memory .\nThe meta- analysis revealed a detrimental effect of T2DM on cognitive sub-domains , namely , episodic memory and cognitive flexibility .\nThere was a trend for the logical memory , phonemic fluency and processing speed to be affected .\nThe analysis indicates that T2DM is a detrimental factor on certain cognitive sub-domains , rendering the person vulnerable to subsequent 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: BACKGROUND / OBJECTIVE Repetitive transcranial magnetic stimulation ( rTMS ) has been mainly studied as adjunctive treatment for drug-resistant patients . We assessed the effectiveness of rTMS started concomitantly with antidepressant medications in non-drug-resistant major depressive disorder patients . We also evaluated if , among the 3 antidepressants administered , one had a better synergy with rTMS . METHOD In this 5-week , double-blind , r and omized , sham-controlled study , we recruited 99 in patients suffering from a major depressive episode ( DSM-IV criteria ) . They were r and omly assigned to receive venlafaxine , sertraline , or escitalopram in combination with a 2-week period of sham or active 15-Hz rTMS on the left dorso-lateral prefrontal cortex . Data were gathered from February 2004 to June 2005 . RESULTS The active rTMS group showed a significantly faster reduction in Hamilton Rating Scale for Depression ( HAM-D ) scores compared with the sham group ( p = .0029 ) . The response and remission rates were significantly greater in the active rTMS group after the stimulation period ( p = .002 and p = .003 , respectively ) , but not at the endpoint . We found no significant difference in HAM-D score reduction among the 3 drugs administered , either in the active or in the sham group . CONCLUSION These findings support the efficacy of rTMS in hastening the response to antidepressant drugs in patients with major depressive disorder . The effect of rTMS seems to be unaffected by the specific concomitantly administered drug BACKGROUND Carefully design ed controlled studies are essential in further evaluating the therapeutic efficacy of transcranial magnetic stimulation ( TMS ) in psychiatric disorders . A major method ological concern is the design of the \" sham \" control for TMS . An ideal sham would produce negligible cortical stimulation in conjunction with a scalp sensation akin to real treatment . Strategies employed so far include alterations in the position of the stimulating coil , but there has been little systematic study of their validity . In this study , we investigated the effects of different coil positions on cortical activation and scalp sensation . METHODS In nine normal subjects , single TMS pulses were administered at a range of intensities with a \" figure eight \" coil held in various positions over the left primary motor cortex . Responses were measured as motor-evoked potentials in the right first dorsal interosseus muscle . Scalp sensation to TMS with the coil in various positions over the prefrontal area was also assessed . RESULTS None of the coil positions studied met the criteria for an ideal sham . Arrangements associated with a higher likelihood of scalp sensation were also more likely to stimulate the cortex . CONCLUSIONS The choice of a sham for TMS involves a trade-off between effective blinding and truly inactive \" stimulation . \" Further research is needed to develop the best sham condition for a range of applications This 5-week , r and omized , double-blind , placebo-controlled trial investigated the efficacy and tolerability of high frequency repetitive transcranial magnetic stimulation ( rTMS ) directed to the left prefrontal cortex in drug-resistant depressed patients . Fifty-four patients were r and omly assigned to receive 10 daily applications of either real or sham rTMS . Subjects assigned to receive active stimulation were divided into two further subgroups according to the intensity of stimulation : 80 % vs. 100 % of motor threshold ( MT ) . At study completion , the response rates were 61.1 % ( n=11 ) , 27.8 % ( n=5 ) and 6.2 % ( n=1 ) for the 100 % MT group , 80 % MT group and sham group , respectively . A significant difference ( Pearson chi(2 ) test ) was found between the 100 % MT and sham groups , while the 80 % MT group did not differ significantly from the sham group . Between the two active groups , a marginally significant difference was observed . Analysis of variance with repeated measures on Hamilton Depression Rating Scale scores revealed a significantly different decrease over time of depressive symptomatology among the three treatment groups . Treatment response appeared to be unrelated to the demographic and clinical characteristics recorded , and on the whole the technique was well tolerated . The results of this double-blind trial showed that rTMS may be a useful and safe adjunctive treatment for drug-resistant depressed patients BACKGROUND The role of high-frequency rTMS over the left cortex as an add-on strategy in the treatment of major depression is still uncertain even in patients resistant to pharmacotherapy . We had planned a large sham TMS controlled study in the acute phase with a placebo-controlled relapse-prevention phase with escitalopram . However , because a recent meta- analysis showed only a small effect size of rTMS over sham TMS in the acute treatment phase of depressed patients , we decided to make an interim analysis . METHOD In patients with medication-resistant major depression we administered in a r and omised trial 15 sessions of sham-controlled rTMS over three weeks in combination with 20 mg escitalopram daily . After the last rTMS , the patients were followed for another 9 weeks on 20 mg escitalopram daily . The antidepressant effect was measured by the HAM-D(6 ) as primary outcome scale . RESULTS A total of 45 patients with complete data were r and omised so that 23 patients received sham TMS and 22 patients received active , high-frequency rTMS over the left cortex . Over the 3 weeks , the active rTMS treatment was superior to sham TMS with effect sizes on the HAM-D(6 ) above 0.70 , which indicates not only a statistically but also a clinical ly significant effect . The patients had typically been through two failed antidepressant treatment attempts with non-tricyclics before inclusion in the study . Both the rTMS and escitalopram were well-tolerated . CONCLUSION High-frequency rTMS over the left cortex is an add-on strategy of clinical significance in combination with escitalopram in patients with major depression resistant to non-tricyclic antidepressants OBJECTIVE The present study examined the efficacy and tolerability of acute escitalopram treatment in depressed patients aged 60 years or older . METHODS Patients aged > or = 60 years with Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition major depressive disorder were r and omized to 12 weeks of double-blind , flexible-dose treatment with escitalopram ( 10 - 20 mg/day ; N = 130 ) or placebo ( N = 134 ) . The prospect ively defined primary efficacy end point was change from baseline to week 12 in Montgomery-Asberg Depression Rating Scale ( MADRS ) total score using the last observation carried forward approach . RESULTS A total of 109 ( 81 % ) patients in the placebo group and 96 ( 74 % ) patients in the escitalopram group completed treatment . Mean age in both groups was approximately 68 years . Mean baseline MADRS scores were 28.4 and 29.4 for the placebo and escitalopram treatment groups , respectively . Escitalopram did not achieve statistical significance compared with placebo in change from baseline on the MADRS ( least square mean difference : -1.34 ; last observation carried forward ) . Discontinuation rates result ing from adverse events were 6 % for placebo and 11 % for escitalopram . Treatment-emergent adverse events reported by > 10 % of patients in the escitalopram group were headache , nausea , diarrhea , and dry mouth . CONCLUSIONS Escitalopram treatment was not significantly different from placebo treatment on the primary efficacy measure , change from baseline to week 12 in MADRS . In patients aged 60 years or older with major depression , acute escitalopram treatment appeared to be well tolerated BACKGROUND Transcranial magnetic stimulation ( TMS ) is a noninvasive method to stimulate the cortex , and the treatment of depression is one of its potential therapeutic applications . Three recent meta analyses strongly suggest its benefits in the treatment of depression . The present study investigates whether repetitive TMS ( rTMS ) accelerates the onset of action and increases the therapeutic effects of amitriptyline . METHODS Forty-six out patients meeting DSM-IV criteria for nonpsychotic depressive episode were r and omly assigned to receive rTMS ( n = 22 ) or sham repetitive TMS ( sham ) ( n = 24 ) during 4 weeks over dorsolateral prefrontal cortex ( DLPFC ) in this double-blind controlled trial . All patients were concomitantly taking amitriptyline ( mean dose 110 mg/d ) . The rTMS group received 20 sessions ( 5 sections per week ) of 5 Hz rTMS ( 120 % of motor threshold and 1250 pulses per session ) . Sham stimulation followed the same schedule , however , using a sham coil . The efficacy variables were the Hamilton Depression Rating Scale-17 items ( HAM-D/17 ) , the Montgomery-Asberg Depression Rating Scale ( MADRS ) , a Visual Analogue Scale ( VAS ) , and the Clinical Global Impression ( CGI ) . Tolerability was assessed by clinical examination and a safety screening of TMS side effects . RESULTS Repetitive TMS had a significantly faster response to amitriptyline . There was a significant decrease in HAM-D/17 scores , already after the first week of treatment ( p < .001 compared with baseline and p < .001 compared with sham ) . The decrease in HAM-D/17 scores in the rTMS group was significantly superior compared with the sham group throughout the study ( p < .001 at fourth week ) . CONCLUSIONS Repetitive TMS at 5 Hz accelerated the onset of action and augmented the response to amitriptyline Objective : This study investigated the impact of latency ( the time between illness onset and initiation of prophylactic treatment ) on the outcome of prophylaxis in bipolar disorders Escitalopram , a selective serotonin reuptake inhibitor ( SSRI ) , was compared to placebo in a study of patients with major depressive disorder ( DSM-IV ) who had baseline Montgomery – Åsberg Depression Rating Scale ( MADRS ) total scores ≥22 and ≤40 . After a 1-week , single-blind placebo period , patients were r and omized to receive escitalopram 10 mg/day ( n = 191 ) or placebo ( n = 189 ) in an 8-week , double-blind period . The primary efficacy analysis of adjusted mean change in MADRS total score from baseline showed a statistically significantly larger effect for escitalopram than for placebo with a treatment difference at week 8 ( last observation carried forward , LOCF ) of 2.7 points ( SE 0.85;P = 0.002 ) . In further by-week efficacy analyses , the effect of escitalopram was consistently larger than that of placebo ( P < 0.05 ) beginning at week 1 ( Clinical Global Impression – Improvement score ) , week 2 ( MADRS score ) or week 3 ( Clinical Global Impression – Severity score ) . Escitalopram was very well tolerated with a low overall withdrawal rate similar to that for placebo . Nausea was the only adverse event reported significantly more in escitalopram-treated patients than in placebo-treated patients , although it was infrequent and transient . Escitalopram 10 mg/day had a statistically significantly better antidepressant effect than placebo as early as week 1 , and was safe and very well tolerated BACKGROUND / OBJECTIVE There is evidence for an antidepressant effect of repetitive transcranial magnetic stimulation ( rTMS ) , but little is known about posttreatment course . Therefore , we conducted a placebo-controlled , double-blind study in depressed patients in order to investigate the effect of rTMS on depression over 12 weeks after completion of the 2-week stimulation period . METHOD 55 patients with a moderate or severe DSM-IV major depressive episode were r and omly assigned to rTMS or sham treatment . rTMS was given daily for 10 days over the left dorsolateral prefrontal cortex with the following treatment parameters : 20 Hz , 20 trains of 2 seconds , 30 seconds between trains , and 80 % motor threshold . The effect of rTMS on depression was rated repeatedly with the 17-item Hamilton Rating Scale for Depression ( HAM-D ) during the 2-week period of stimulation and the 12-week follow-up period conducted from 1997 to 2001 . RESULTS We found a modest , clinical ly nonrelevant decrease in HAM-D scores in both rTMS and sham patients over 2 weeks of treatment . However , over the subsequent 12-week follow-up , the rTMS group continued to improve significantly compared with the placebo group . CONCLUSION Decrease of depressive symptoms may continue after the cessation of rTMS stimulation BACKGROUND Studies of repetitive transcranial magnetic stimulation ( rTMS ) in depression have mostly involved once-daily treatment , with positive but modest clinical results . This study tested the efficacy and safety of twice-daily rTMS over 2 weeks . METHOD Thirty-eight depressed subjects enrolled in a double-blind , sham-controlled trial of twice-daily rTMS ( left prefrontal cortex , 10 Hz , 110 % intensity , 1500 stimuli per session ) over 2 weeks . Mood and neuropsychological functioning were assessed weekly by blind raters , using the Montgomery-Asberg Depression Rating \n Output:\n " }, { "from": "agent", "value": "Exploratory analyses show that sham response is associated with refractoriness and with the use of rTMS as an add-on therapy , but not with age , gender and sham method utilized .\n/ SIGNIFICANCE We confirmed that placebo response in MDD is large regardless of the intervention and is associated with depression refractoriness and treatment combination ( add-on rTMS studies ) .\nThe magnitude of the placebo response seems to be related with study population and study design rather than the intervention itself" } ]

[ { "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 examine demographic , behavioral and dietary correlates of frequency of fast food restaurant use in a community-based sample of 891 adult women . DESIGN : A survey was administered at baseline and 3 y later as part of a r and omized , prospect i ve intervention trial on weight gain prevention . SUBJECTS : Women ( n=891 ) aged 20–45 y who enrolled in the Pound of Prevention study . MEASUREMENTS : Frequency of fast food restaurant use , dietary intake , demographic and behavioral measures were self-reported . Dietary intake was measured using the 60-item Block Food Frequency Question naire . Body weight and height were directly measured . RESULTS : Twenty-one percent of the sample reported eating ≥3 fast food meals per week . Frequency of fast food restaurant use was associated with higher total energy intake , higher percentage fat energy , more frequent consumption of hamburgers , French fries and soft drinks , and less frequent consumption of fiber and fruit . Frequency of fast food restaurant use was higher among younger women , those with lower income , non-White ethnicity , greater body weight , lower dietary restraint , fewer low-fat eating behaviors , and greater television viewing . Over 3 y , increases in frequency of fast food restaurant use were associated with increases in body weight , total energy intake , percentage fat intake , intake of hamburgers , French fries and soft drinks , and with decreases in physical activity , dietary restraint and low-fat eating behaviors . Intake of several other foods , including fruits and vegetables , did not differ by frequency of fast food restaurant use . CONCLUSION : Frequency of fast food restaurant use is associated with higher energy and fat intake and greater body weight , and could be an important risk factor for excess weight gain in the population OBJECTIVE To compare the average out-of-home ( OH ) consumption of foods and beverages , as well as energy intake , among population s from 10 European countries and to describe the characteristics of substantial OH eaters , as defined for the purpose of the present study , in comparison to other individuals . DESIGN Cross-sectional study . Dietary data were collected through single 24-hour dietary recalls , in which the place of consumption was recorded . For the present study , substantial OH eaters were defined as those who consumed more than 25 % of total daily energy intake at locations other than the household premises . Mean dietary intakes and the proportion of substantial OH eaters are presented by food group and country . Logistic regression analyses were used to estimate the odds of being a substantial OH eater in comparison to not being one , using mutually adjusted possible non-dietary determinants . SETTING Ten European countries participating in the European Prospect i ve Investigation into Cancer and Nutrition ( EPIC ) . SUBJECTS The subjects were 34 270 individuals , 12 537 men and 21 733 women , aged 35 - 74 years . RESULTS The fraction of energy intake during OH eating was generally higher in northern European countries than in the southern ones . Among the food and beverage groups , those selectively consumed outside the home were coffee/tea/waters and sweets and , to a lesser extent , cereals , meats , added lipids and vegetables . Substantial OH eating was positively associated with energy intake and inversely associated with age and physical activity . Substantial OH eating was less common among the less educated compared with the more educated , and more common during weekdays in central and north Europe and during the weekend in south Europe . CONCLUSIONS Eating outside the home was associated with sedentary lifestyle and increased energy intake ; it was more common among the young and concerned in particular coffee/tea/waters and sweets The influence of information about the fat content of food and cardiovascular disease ( CVD ) prevention on taste ratings and food intake in a test meal was examined . Forty Ss were allocated at r and om to CVD information or control conditions . Ss rated 2 br and s of yogurt and 2 cheese s and wiches , with 1 flavor of each food labeled full-fat and the other low-fat . In fact , fat levels were identical , and the label-flavor pairings were counterbalanced . Overall , Ss gave lower liking ratings to the low-fat labeled foods . However , Ss in the information condition tended to eat a smaller proportion of the full-fat s and wiches . The results supported the utility of a laboratory setting for evaluating the influence of health-relevant information on responses to food The purpose of this study was to investigate the impact of nutritional labelling on energy intake , appetite perceptions and attitudes towards food . During a 10-d period , seventy normal-weight ( BMI < 25 kg/m2 ) and seventy-one obese women ( BMI ≥30 kg/m2 ) were given three meals per d under ad libitum conditions . Participants were r and omly assigned to one of three experimental labelling groups in which the only difference was the label posted on lunch meal entrée : ( 1 ) low-fat label , ( 2 ) energy label ( energy content of the entrée and average daily needs ) and ( 3 ) no label ( control ) . Average energy intake was calculated by weighing all foods before v. after daily consumption . Hunger and fullness perceptions were rated on visual analogue scales immediately before and after each meal . Satiety efficiency was assessed through the calculation of the satiety quotient ( SQ ) . The appreciation and perceived healthiness of the lunch entrées were rated on eight-point Likert scales . There was no difference in energy intake , SQ and attitudes towards food between the three labelling groups . Fasting hunger perception was higher in the low-fat label group compared with the two others groups ( P=0·0037 ) . No interactions between labelling groups and BMI categories were observed . In conclusion , although labelling does not seem to influence energy intake , a low-fat label may increase women 's fasting hunger perceptions compared with an energy label or no label Background There has been a trend towards increased dining out in many countries . Consuming food prepared out of the home has been linked to poor diet quality , weight gain , and diabetes risk , but whether having meals prepared at home ( MPAH ) is associated with risk of type 2 diabetes ( T2D ) remains unknown . Methods and Findings We followed 58,051 women ( from 1986 to 2012 ) and 41,676 men ( from 1986 to 2010 ) in two prospect i ve cohort studies of health professionals . Frequencies of consuming midday or evening MPAH were assessed at baseline and during follow-up . Incident T2D was identified through self-report and confirmed using a vali date d supplementary question naire . During 2.1 million person-years of follow-up , 9,356 T2D cases were documented . After adjusting for demographic , socioeconomic , and lifestyle factors , hazard ratios ( HRs ) and 95 % confidence intervals ( 95 % CIs ) of T2D were 1 ( reference ) , 0.93 ( 0.88–0.99 ) , 0.96 ( 0.90–1.03 ) , and 0.86 ( 0.81–0.91 ) for those eating 0–6 , 7–8 , 9–10 , and 11–14 MPAH ( p-trend < 0.001 ) per week , respectively . Participants eating 5–7 midday MPAH had 9 % lower T2D risk than those with 0–2 midday MPAH , and participants having 5–7 evening MPAH had 15 % lower risk than those with 0–2 evening MPAH ( both p-trend < 0.001 ) . In the first 8 y of follow-up , women and men who consumed 11–14 MPAH per week had 0.34 kg ( 95 % CI : 0.15–0.53 ; p < 0.001 ) and 1.23 kg ( 95 % CI : 0.92–1.54 ) less weight gain than those with 0–6 MPAH , respectively . Among participants who were nonobese ( body mass index [ BMI ] < 30 kg/m2 ) at baseline , pooled HR ( 95 % CI ) of developing obesity ( BMI ≥ 30 kg/m2 ) was 0.86 ( 0.82–0.91 ; p-trend < 0.001 ) when extreme MPAH groups ( 11–14 MPAH versus 0–6 MPAH ) were compared . When midday and evening MPAH were analyzed separately , HRs comparing extreme groups ( 5–7 MPAH versus 0–2 MPAH ) were 0.93 ( 95 % CI : 0.89–0.97 , p-trend = 0.003 ) for midday MPAH and 0.76 ( 95 % CI : 0.70–0.83 ; p-trend < 0.001 ) for evening MPAH . Further adjusting for BMI during follow-up attenuated the association between MPAH and T2D risk : the HR ( 95 % CI ) for participants with 11–14 MPAH was 0.95 ( 0.89–1.01 , p-trend = 0.13 ) . The main limitations of our study were that it lacked assessment s on individual foods constituting the MPAH and that the findings were limited to health professionals with a relatively homogeneous socioeconomic status . Conclusions In two large prospect i ve cohort studies , frequent consumption of MPAH is associated with a lower risk of developing T2D , and this association is partly attributable to less weight gain linked with this dining behavior The present study examined whether low-fat labeling and caloric information affect food intake , calorie estimates , taste preference , and health perceptions . Participants included 175 female undergraduate students who were r and omly assigned to one of four experimental conditions . A 2 × 2 between subjects factorial design was used in which the fat content label and caloric information of chocolate c and y was manipulated . The differences in food intake across conditions did not reach statistical significance . However , participants significantly underestimated the calorie content of low-fat-labeled c and y. Participants also rated low-fat-labeled c and y as significantly better tasting when they had caloric information available . Participants endorsed more positive health attributions for low-fat-labeled c and y than for regular-labeled c and y , independent of caloric information . The inclusion of eating attitudes and behaviors as covariates did not alter the results . The study findings may be related to the \" health halo \" associated with low-fat foods and add to the research base by examining the interaction between low-fat and calorie labeling Purpose . Determine the effect of menu labels displaying the energy content of food items or the exercise equivalent on energy ordered and consumed at lunch and energy intake for the remainder of the day in young adults . Design . Subjects were r and omized to a menu with no labels ( no-labels ) , menu with kilocalorie labels displaying the energy content of the food items ( kcal-labels ) , or menu with exercise labels displaying the minutes of brisk walking needed to burn the food energy ( exercise-labels ) . Setting . The study was conducted in one dining area located in a metabolic kitchen at the Texas Christian University and another located in a residence occupied by graduate students . Subjects . Of the 300 subjects , 55.7 % were female , 77.3 % were college students , 88 % were white , and 88 % were non-Hispanic . Mean body mass index and age were 24.2 ± 4.5 kg/m2 and 21.9 ± 2.3 years , respectively . Intervention . All menus contained the same food/beverage choices . Subjects ordered and consumed foods/beverages for lunch from the menu to which they were assigned . Subjects were blinded to study purpose . Measures . Energy ordered and consumed at lunch were assessed from the weight of the food ordered and consumed , respectively , and the energy content of the same foods available on the restaurant Web site . Postlunch energy intake was assessed by food recall . Analysis . Analysis of covariance , adjusted for premeal hunger levels and gender , determined the effect of menu type on energy ordered and consumed and postlunch energy intake . Results . Significant menu effect was observed for energy ordered ( p = .008 ) and consumed ( p = .04 ) at lunch . The exercise-labels group ordered significantly ( p = .002 ) less energy ( adjusted mean [ confidence intervals ] : 763 [ 703 , 824 ] kcal ) at lunch , compared to the no-labels group ( 902 [ 840 , 963 ] kcal ) but not compared to the kcal-labels group ( 827 [ 766 , 888 ] kcal ) . The exercise-labels group also consumed significantly ( p = .01 ) less energy ( 673 [ 620 , 725 ] kcal ) at lunch , compared to the no-labels group ( 770 ( 717 , 823 ) kcal ) but not compared to the kcal-labels group ( 722 [ 669 , 776 ] kcal ) . Energy ordered and consumed were not different between kcal-labels and no-labels groups . There was no difference in postlunch energy intake by menu type . Conclusion . The menu with exercise-labels result ed in less energy ordered and consumed and this did not lead to greater energy consumption post lunch , compared to the menu with no-labels in young adults largely made up of normal-weight , non-Hispanic white college students Increased visibility of food labels is a potential method to reduce the rate of obesity . However , few empirical studies have investigated the impact of nutrition labeling on food selection or energy intake . This study tested the hypothesis that nutrition labeling in combination with nutrition label education would promote reductions in energy int \n Output:\n " }, { "from": "agent", "value": "Conclusions Nutrition and health information presented on food labels has varying impacts on portion sizes consumed , from increased to decreased intake ." } ]

[ { "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 Central venous access devices ( CVADs ) are a mainstay of current medical therapy but often become occluded by thrombus . Tissue plasminogen activator ( alteplase ) , at a dose of 2 mg per 2 mL , has been shown to be effective in restoring flow to catheters proven by radiographic contrast injection to be occluded by thrombus . The purpose of this double-blind placebo-controlled multicenter trial was to determine the efficacy of alteplase in occluded catheters without earlier contrast injections or radiographic examinations . MATERIAL S AND METHODS Patients were eligible for inclusion if blood could not be withdrawn from their catheter after a period of normal function of at least 48 hours . Single or multiple catheters , peripherally inserted central catheters , catheters with valves , and implanted ports were eligible ; catheters used for hemodialysis were not included . Patients were r and omly assigned to one of two groups . In one group , patients received a first dose of 2 mg alteplase followed , if needed , by a second dose of 2 mg alteplase and a third dose of placebo . The other group received placebo first followed by one 2-mg dose of alteplase and then a second , if needed . Each dose was allowed to dwell for 2 hours and ability to withdraw blood from the catheter was reassessed . The endpoint was restoration of the ability to withdraw and infuse through the catheter . One hundred forty-nine patients were r and omized : 74 received placebo first , 75 received alteplase first . RESULTS After the first 2-hour treatment , function was restored to 74 % in the alteplase arm and 17 % in the placebo arm ( P < .0001 compared to placebo ) . After one or two treatments , function was restored in 90 % of patients . There were no serious study -drug-related adverse events , no intracranial hemorrhage , no major hemorrhage , and no embolic events . CONCLUSION Infusion of alteplase appeared to be safe and effective in restoring flow to occluded catheters without need for pretreatment radiographic evaluation The function of long term indwelling venous access devices is commonly perturbed by postinsertion catheter‐related complications ( CRC ) . In an effort to assess the patterns of CRC in our community accurately , a prospect i ve analysis of Groshong catheters in adult cancer patients was undertaken PURPOSE To evaluate , in a phase III , single-arm study , the safety and efficacy of the thrombolytic agent tenecteplase in restoring function to dysfunctional central venous catheters ( CVCs ) . MATERIAL S AND METHODS Pediatric and adult patients with dysfunctional CVCs were eligible to receive as much as 2 mL ( 2 mg ) of intraluminal tenecteplase , which was left to dwell in the CVC lumen for a maximum of 120 minutes . If CVC function was not restored at 120 minutes , a second dose was instilled for an additional 120 minutes . RESULTS Tenecteplase was administered to 246 patients . Mean patient age was 44 years ( range , 0 - 92 y ) ; 72 patients ( 29 % ) were younger than 17 years of age . Chemotherapy was the most common reason for catheter insertion . Restoration of CVC function was achieved in 177 patients ( 72 % ) within 120 minutes after the first dose . After instillation of a maximum of two doses of tenecteplase , CVC function was restored in 200 patients ( 81 % ) , with similar frequencies in pediatric ( 83 % ) and adult ( 80 % ) patients . Adverse events ( AEs ) were reported in 31 patients ( 13 % ) ; fever ( 2 % ) , neutropenia ( 1 % ) , and nausea ( 0.8 % ) were most common . One serious AE , an allergic hypersensitivity reaction , was judged to be related to tenecteplase and /or a chemotherapeutic agent that the patient was receiving concurrently . CONCLUSIONS Consecutive administration of one or two doses of tenecteplase into CVCs showed efficacy in the restoration of catheter function in patients with dysfunctional CVCs PURPOSE This study was undertaken to determine the role of low-dose urokinase infusions in treating fibrinous occlusions of venous access devices ( VADs ) in cancer patients . PATIENTS AND METHODS Forty-two patients with VAD occlusions refractory to routine urokinase instillations were documented by x-ray ( cathetergram ) to have fibrin sleeves at the catheter tips . They were r and omized to receive infusions of either urokinase ( 40,000 U/h ) or urokinase with heparin ( 320 U/h ) through their catheters . After 1 , 3 , 6 , and 12 hours of treatment , the function of the VADs was reassessed . Whenever the obstruction had been relieved , the infusion was stopped and a repeat cathetergram was performed . The status of the unoccluded catheters was followed to determine the longevity of the restored function . RESULTS Twenty-one catheters were treated with urokinase alone and 21 with the combination of urokinase and heparin . In each group , 16 VADs opened within 12 hours of treatment and five did not . By actuarial analysis , the probability was only 0.28 that a reopened catheter would reocclude within 6 months . CONCLUSION Low-dose urokinase infusions can restore function to the majority of catheters occluded by fibrin sleeves . Adding heparin to the urokinase does not enhance the efficacy of the infusions . The restored function often persists until the VADs are removed PURPOSE Recombinant urokinase ( r-UK ) is a high-molecular-weight urokinase produced in transfected , non-human , mammalian cells . A Phase II , r and omized , double-blind , parallel , placebo-controlled , dose-ranging study was performed to compare the safety and efficacy of one or two instillations of three intraluminal concentrations of r-UK ( 5,000 ; 15,000 ; and 25,000 IU/mL ) with a placebo for reestablishment of total function to occluded central venous access devices ( CVADs ) . MATERIAL S AND METHODS One-hundred eight patients with CVAD withdrawal or total occlusion were enrolled and r and omized to treatment ; 104 patients received at least one instillation of study drug and 101 patients completed treatment . All but one patient had cancer . RESULTS All three concentrations of r-UK were significantly superior to placebo in restoring total CVAD function ( patency of all occluded lumens ) after one or two instillations of study medication ( 25,000 IU/mL r-UK , 68 % vs. placebo , 28 % [ P = .007 ] ; 15,000 IU/mL r-UK , 69 % vs. placebo , 24 % [ P = .004 ] ; 5,000 IU/mL r-UK , 70 % vs. placebo , 28 % [ P = .003 ] ) . Comparisons of the three r-UK concentrations indicated no difference after one or two instillations with regards to patency restoration . Treatment-emergent hemorrhagic events occurring within 72 hours after study drug exposure were experienced by four patients ( 17 % ) in the 25,000 IU/mL r-UK group , two patients ( 7 % ) in the 15,000 IU/mL r-UK group , no patients in the 5,000 IU/mL r-UK group , and no patients in the placebo group . CONCLUSIONS Efficacy and safety results of this study support further evaluation of a 5,000 IU/mL concentration of r-UK for treatment of occluded CVADs in adult and pediatric patients from 1 year of age PURPOSE To evaluate the incidence and management of catheter occlusion in implantable arm ports . MATERIAL S AND METHODS Findings were prospect ively examined in 391 patients in whom 393 arm ports were placed . The indications for port placement included chemotherapy ( n = 347 ) , antibiotic administration ( n = 35 ) , combination chemotherapy/antibiotic use ( n = 7 ) , transfusion ( n = 3 ) , and phlebotomy ( n = 1 ) . Of the total catheters , 323 ( 82.2 % ) underwent tip modification prior to placement . Malfunctioning catheters were usually treated with urokinase instillation . RESULTS Three hundred ninety-three devices were implanted with 247 mean days of catheter use ( total , 97,256 days ; range , 1 - 694 days ) . The overall incidence of catheter occlusion was 0.14 per 100 catheter days . A single catheter occlusion occurred in 90 ( 22.9 % ) catheters , with a mean of 90.1 days before the event . A second occlusion occurred in 36 ( 9.2 % ) of the above catheters , with a mean of 60.1 catheter days before the second event . Eighty-five ( 24.0 % ) of the 347 cancer patients had at least one occlusive event , yielding a complication rate of 0.098 per 100 catheter days at risk ( 95 % confidence interval [ CI ] ; 0.079 - 0.114 ) . Of the 35 patients receiving antibiotics , three ( 8.6 % ) had at least one occlusive event . This represented a complication rate of 0.032 per 100 catheter days at risk ( 95 % CI ; 0.010 - 0.061 ) . Seventeen ( 24.3 % ) of the nonmodified catheters developed an occlusion versus 72 ( 22.3 % ) of the modified ( P > .05 ; Fisher exact test ) . Of the catheters with a first occlusive event , 75 ( 98.7 % ) were treated successfully with urokinase instillation . Four ( 1.0 % ) patients developed symptomatic subclavian vein thrombosis . No bleeding complications occurred . CONCLUSION Catheter occlusion is a common complication of long-term arm port placement , with a significantly higher incidence in the cancer patients in our series ( P < . 05 , Fisher exact test ) . Catheter tip modification , however , does not considerably affect the incidence of occlusion . Low-dose urokinase therapy is a safe and efficacious treatment of catheter occlusion , obviating the need for catheter removal PURPOSE Alfimeprase is a recombinantly produced , genetically modified variant of the metalloproteinase , fibrolase . Alfimeprase proteolytically cleaves fibrin , independent of plasminogen activation to plasmin , and directly dissolves thrombi . Based on the direct fibrin degradation effect of alfimeprase , rapid activity in patients with occluded central venous access devices ( CVADs ) was hypothesized . PATIENTS AND METHODS We performed a phase II , r and omized , double-blind , active-control , multicenter , dose-ranging study to compare the safety and efficacy of one or two instillations of three intraluminal doses of alfimeprase ( 0.3 , 1.0 , and 3.0 mg ) and alteplase 2.0 mg in re-establishing patency to occluded CVADs in 55 adult patients . RESULTS All three alfimeprase doses were more successful than alteplase during the first 15 and 30 minutes of treatment . The alfimeprase 3.0-mg dose result ed in 40 % , 50 % , and 60 % patency restoration rates at 5 , 15 , and 30 minutes , respectively , compared with 0 % , 0 % , and 23 % for alteplase . The difference at 15 minutes was highly significant ( P = .0075 ) . Alfimeprase 3.0 mg produced the highest patency rate at 120 minutes after the first ( 60 % ) and second ( 80 % ) doses . No major hemorrhagic or embolic events were reported . CONCLUSION A single 1- or 3-mg dose of alfimeprase has the potential to restore function to occluded CVADs rapidly and safely , and to facilitate on-time infusion of vital therapies PURPOSE To evaluate the efficacy and safety of reteplase for central venous catheter ( CVC ) occlusion in patients with cancer . MATERIAL S AND METHODS An open-label , single-arm , prospect i ve study was conducted . Reteplase ( 0.4 U ) was instilled into each catheter lumen with a dwell time of 30 minutes in patients with cancer with a dysfunctional CVC . If the function of the catheter was not restored in 30 minutes , an additional dwell time of 30 minutes was allowed ( a total of 60 minutes possible dwell time for the first dose ) . A second dose was repeated at 60 minutes after the first dose if catheter function was not restored ( a total of 120 minutes for up to two doses ) . The primary efficacy outcome was the restoration of CVC function . RESULTS Of 139 patients who received reteplase , the first-attempt success rate after a 30-minute dwell time was 66.9 % \n Output:\n " }, { "from": "agent", "value": "Conclusion The most common interventions used to treat thrombotic catheter occlusion in cancer patients were urokinase and alteplase ." } ]

[ { "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 Damage to the inferior alveolar nerve when extracting lower third molars is often caused by the intimate relationship between the nerve and the roots of the teeth . The technique of coronectomy , or intentional root retention , may minimize this problem . PATIENTS AND METHODS Forty-one patients underwent coronectomy on 50 lower third molars with follow-up of at least 6 months . The technique of coronectomy deliberately protected the lingual nerve as part of the surgical procedure . All roots were left at least 3 mm below the buccal and lingual plates of bone . All patients were radiographed preoperatively , immediately postoperatively , and after 6 months . RESULTS There were no cases of inferior alveolar nerve-involved damage in this study of 41 patients who underwent 50 coronectomies . There was 1 case of transient lingual nerve involvement , probably from the use of the lingual retractor . One patient required subsequent removal of the roots of both lower third molars because of failure to heal , and 1 patient required subsequent removal of a root because of subsequent migration to the surface . Root migration was noted in approximately 30 % of patients over a 6 month period . CONCLUSION Coronectomy appears to be a viable technique in those cases where removal of the whole tooth might put the inferior alveolar nerve at considerable risk of damage . The technique appears to be associated with a low incidence of complications , but subsequent migration of the roots may be an issue in the long term PURPOSE Studies have suggested that coronectomy reduces the risk of inferior alveolar nerve injury ( IANI ) when a close relationship with the inferior alveolar canal is indicated on panoramic imaging . However , the relationship between the inferior alveolar canal and the root are unclear on panoramic imaging . Our aim was to compare coronectomy with traditional extraction for the treatment of m and ibular third molars that had clear high IANI risks as evaluated by dental computed tomography . PATIENTS AND METHODS We design ed a case-control study of subjects with high-risk signs of IANI on panoramic images evaluated by dental computed tomography before enrollment . The 220 patients enrolled were assigned to extraction ( control group , n = 118 ) or coronectomy ( case group , n = 102 ) . RESULTS The mean follow-up time was 13 months in the extraction group and 13.5 months in the coronectomy group . Six IANIs ( 5 % ) were found in the extraction group . In the coronectomy group , 1 patient ( 1 % ) had symptoms of neurapraxia , which disappeared within 1 month . Four remaining roots had signs of postoperative infection , and the patients underwent extraction of the root . No nerve damage result ed in these patients after repeat extraction . CONCLUSIONS Coronectomy might reduce the risk of nerve injury for patients at true high risk of IANI as evaluated by dental computed tomography . A long-term postoperative review is needed to assess the incidence of root migration and the root extraction and infection rates after coronectomy PURPOSE There is no long-term evaluation on the safety of coronectomy of the lower third molar . The aim of this study was to investigate the 3-year morbidity of coronectomy of the lower third molars and to monitor the behavior and migration pattern of the retained roots after coronectomy . MATERIAL S AND METHODS This was a prospect i ve cohort study . Patients with lower third molars with specific radiographic sign(s ) showing proximity of the roots to the inferior alveolar nerve who underwent coronectomy in a previous r and omized clinical trial were review ed postoperatively in the first week and the third , sixth , 12th , 24th , and 36th months . The morbidities of infection , pain , root eruption , reoperation to remove the root , and the development of any pathology were recorded . The pattern of any root migration was analyzed . RESULTS Ninety-eight patients ( 35 men and 63 women ; mean age , 25.7 yrs ; st and ard deviation , 7.9 yrs ) with 135 coronectomies completed the 36-month review . None presented with infection or pain from the postoperative third month onward . Root eruption causing sensitivity occurred in 3 % ( 4/135 ) of the sample and the erupted roots were removed . None of the reoperated cases presented with a postoperative inferior alveolar nerve deficit . No pathology developed in any of the retained roots after coronectomy . Root migration was noted in most cases in the first 12 months , and all roots stopped migrating from the 24th month onward . The mean root migration at 36 months was 2.8 mm ( st and ard deviation , 1.4 mm ) . CONCLUSIONS This study confirms that retained roots after coronectomy in the lower third molars produce no complications in terms of infection , pain , or the development of pathologies within the first 3 years . Root eruption can occur in a very small percentage of patients and may require reoperation to remove the root OBJECTIVE The objective of this study was to compare the surgical complications and neurosensory disturbances of coronectomy and total excision of lower wisdom teeth with roots in close proximity to the inferior dental nerve ( IDN ) . STUDY DESIGN A r and omized controlled trial was conducted to compare the surgical complications and IDN deficit of coronectomy and total removal of wisdom teeth . Patients with specific radiographic signs of close proximity of wisdom teeth roots to the IDN were r and omized . RESULTS A total of 231 patients underwent surgery for 349 lower wisdom teeth ( 171 coronectomies , 178 controls ) ; 16 coronectomies failed and were removed in total . Nine patients in the control group presented with IDN deficit , compared with 1 in coronectomy group ( P = .023 ) . Pain and dry socket incidence was significantly lower in the coronectomy group , and there were no statistical differences in infection rate between the 2 groups . Reoperation of one coronectomy case was performed owing to persistent root exposure . CONCLUSION There are fewer complications in terms of IDN deficit , pain , and dry socket after coronectomy , but the infection rate is similar to that of total excision We r and omised 128 patients who required operations on m and ibular third molars and who had radiological evidence of proximity of the third molar to the canal of the inferior alveolar nerve to one of two operations : extraction [ n=102 ] , and coronectomy [ n=94 ] . Some roots were dislodged during intended coronectomy and were therefore removed , result ing in two subgroups ( successful coronectomy n=58 , and failed coronectomy n=36 ) . The mean ( S.D. ) follow up was 25 ( 13 ) months . Nineteen nerves were damaged ( 19 % ) after extraction , none after successful coronectomy , and three ( 8 % ) after failed coronectomy ( p=0.01 ) . The incidence of dry socket infection was similar in the three groups ( 10/102 , 10 % , 7/58 , 12 % , and 4/36 , 11 % , respectively ) . No root required removal or reoperation . To our knowledge this is the first clinical trial of the efficacy of coronectomy in preserving the inferior alveolar nerve . The length of follow up was about 2 years , which for the assessment of delayed eruption of the root fragments is not sufficient as this process may continue for up to 10 years . However , it seems that coronectomy reduces the incidence of injury to the inferior alveolar nerve without increasing the risk of dry socket or infection Coronectomy involves removal of a crown from roots of a healthy tooth in healthy patients indicated to prevent inferior alveolar nerve injury in a high risk case . Since the original paper in 2005 ( 2005 ; 43 : 7–12 ) describing a prospect i ve r and omised study on coronectomy , there has been a lot of interest in this procedure and it has become routine practice in many oral surgery departments within the UK and USA . A significant variance in thresholds for prescribing coronectomy and also for the technique of its delivery has been highlighted by a recent review . This has result ed in frequent queries about the technique and which patients may be suitable . Thus this paper aims to highlight some finer points of the coronectomy technique and how to avoid potential pitfalls PURPOSE Close proximity of the inferior alveolar nerve ( IAN ) to the third molar roots can result in nerve injuries during extraction of third molars . Consequently , it is necessary to determine the relationship of the nerve and roots to avoid damage to the IAN . Computed tomography scans are widely used to determine the correct relationship between the IAN and lower third molars . PATIENTS AND METHODS The study consisted of 10 patients with 16 lower third molars in close relationship with the IAN who were divided into a study group and a control group . The patients in the study group were treated via coronectomies performed with endodontic treatments . The patients in the control group underwent coronectomies without endodontic treatment . The patients were followed up for at least 1 year . RESULTS We had to extract 7 of the roots because of the infection in 8 patients belonging to the study group , which were treated endodontically . Moreover , there were 3 cases of IAN damage because of the extraction in the study group . However , in the control group , no infection was determined and IAN damage was absent . CONCLUSION Coronectomy appears to be a reliable technique to protect the IAN from damage . This procedure has a low incidence of complications . Endodontic treatment does not affect the success of this method according to our results \n Output:\n " }, { "from": "agent", "value": "RESULTS The following articles were obtained which represents a total of 17 : 1 systematic review , 2 r and omized clinical trials and 2 non-r and omized clinical trials , 3 cohort studies , 2 retrospective studies , 3 case studies and 4 literature review s. CONCLUSIONS Coronectomy is an adequate preventative technique in protecting the inferior alveolar nerve , which is an alternative to the conventional extraction of third molars , which unlike the former technique , presents a high risk of injury to the inferior alveolar nerve ." } ]

[ { "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 . This prospect i ve r and omized intervention investigated whether training on a balance board could reduce the amount of traumatic injuries of the lower extremities in female soccer players . A total of 221 female soccer players from 13 different teams playing in the second and third Swedish divisions volunteered to participate in the study . Seven teams ( n=121 ) were r and omized to an intervention group and six teams ( n=100 ) to a control group and were followed during one outdoor season ( April – October ) . Before and after the season muscle flexibility and balance/postural sway of the lower extremities were measured in the players . There were no significant differences in age , height , weight , muscle flexibility and balance/postural sway of the lower extremities between the intervention and the control group . During the season the players in the intervention group performed a special training program consisting of 10–15 min of balance board training in addition to their st and ard soccer practice and games . After a 37 % drop-out the intervention group consisted of 62 players and the control group of 78 players . The results showed no significant differences between the groups with respect either to the number , incidence , or type of traumatic injuries of the lower extremities . The incidence rate of \" major \" injuries was higher in the intervention group than in the control group . Four of five anterior cruciate ligament injuries occurred in the intervention group , which means that we could not prevent severe knee injuries in female soccer players with balance board training . However , among the players who had been injured during the 3-month period prior to this investigation there were significantly more players from the control group than from the intervention group who sustained new injuries during the study period Background : Sport is the leading cause of injury requiring medical attention among adolescents . We studied the effectiveness of a home-based balance-training program using a wobble board in improving static and dynamic balance and reducing sports-related injuries among healthy adolescents . Methods : In this cluster r and omized controlled trial , we r and omly selected 10 of 15 high schools in Calgary to participate in the fall of 2001 . We then recruited students from physical education classes and r and omly assigned them , by school , to either the intervention ( n = 66 ) or the control ( n = 61 ) group . Students in the intervention group participated in a daily 6-week and then a weekly 6-month home-based balance-training program using a wobble board . Students at the control schools received testing only . The primary outcome measures were timed static and dynamic balance , 20-m shuttle run and vertical jump , which were measured at baseline and biweekly for 6 weeks . Self-reported injury data were collected over the 6-month follow-up period . Results : At 6 weeks , improvements in static and dynamic balance were observed in the intervention group but not in the control group ( difference in static balance 20.7 seconds , 95 % confidence interval [ CI ] 10.8 to 30.6 seconds ; difference in dynamic balance 2.3 seconds , 95 % CI 0.7 to 4.0 seconds ) . There was evidence of a protective effect of balance training in over 6 months ( relative risk of injury 0.2 , 95 % CI 0.05 to 0.88 ) . The number needed to treat to avoid 1 injury over 6 months was 8 ( 95 % CI 4 to 35 ) . Interpretation : Balance training using a wobble board is effective in improving static and dynamic balance and reducing sports-related injuries among healthy adolescents The purpose of this study was to determine the effect of a 4-week balance training program on specified functional tasks . Thirty-six subjects ( age = 22.7 ± 2.10 years ; height = 168.30 ± 9.55 cm ; weight = 71.15 ± 16.40 kg ) were r and omly placed into control ( C ; n = 19 ) and experimental groups ( Tx ; n = 17 ) . The Tx group trained using a commercially available balance training device ( BOSU ) . Postural limits ( displacement and sway ) and functional task ( time on ball , shuttle run , and vertical jump ) were assessed during a pretest ( T1 ) , a posttest ( T2 ) , and 2 weeks posttraining ( T3 ) . Multivariate repeated measures analysis ( a = 0.05 ) revealed significant differences in time on ball , shuttle run , total sway , and fore/aft displacement after the exercise intervention ( T2 ) . T3 assessment revealed that total sway and time on ball remained controlled ; however , no other measures were retained . Balance training improved performance of selected sport-related activities and postural control measures , although it is unclear whether the effect of training would transfer to general functional enhancement Balancing exercises on instable bases ( sensorimotor training [ SMT ] ) are often used in the rehabilitation process of an injured athlete to restore joint function . Recently it was shown that SMT was able to enhance rate of force development ( RFD ) in a maximal voluntary muscle contraction . The purpose of this study was to compare adaptations on strength capacity following ballistic strength training ( BST ) with those following an SMT during a training period of 1 microcycle ( 4 weeks ) . Maximum voluntary isometric strength ( MVC ) , maximum RFD ( RFDmax ) and the corresponding neural activation of M. soleus ( SOL ) , M. gastrocnemius ( GAS ) , and M. tibialis anterior ( TIB ) were measured during plantar flexion in 33 healthy subjects . The subjects were r and omly assigned to a SMT , BST , or control group . RFDmax increased significantly stronger following BST ( 48 ± 16 % ; p < 0.01 ) compared to SMT ( 14 ± 5 % ; p < 0.05 ) , whereas MVC remained unchanged in both groups . Median frequencies of the electromyographic power spectrum during the first 200 ms of contraction for GAS increased following both BST ( 45 ± 21 % ; p < 0.05 ) and SMT ( 45 ± 22 % ; p < 0.05 ) , but median frequencies for SOL increased only after SMT ( 13 ± 4 % ; p < 0.05 ) . Additionally , mean amplitude voltage increased following BST for SOL ( 38 ± 12 % ; p < 0.01 ) and for GAS ( 73 ± 23 % ; p < 0.01 ) during the first 100 ms , whereas it remained unchanged after SMT . It is concluded that BST and SMT may induce different neural adaptations that specifically affect recruitment and discharge rates of motor units at the beginning of voluntary contraction . Specific neural adaptations indicate that SMT might be used complementarily to BST , especially in sports that require contractile explosive properties in situations with high postural dem and s , e.g. , during jumps in ball sports Background : A number of studies have shown that proprioception training can reduce the risk of injuries in pivoting sports , but the mechanism is not clearly understood . Aim : To determine the contributing effects of propioception on knee joint position sense among team h and ball players . Study design : Prospect i ve cohort study . Methods : Two professional female h and ball teams were followed prospect ively for the 2005–6 season . 20 players in the intervention team followed a prescribed proprioceptive training programme while 19 players in the control team did not have a specific propioceptive training programme . The coaches recorded all exposures of the individual players . The location and nature of injuries were recorded . Joint position sense ( JPS ) was measured by a goniometer on both knees in three angle intervals , testing each angle five times . Assessment s were performed before and after the season by the same examiner for both teams . In the intervention team a third assessment was also performed during the season . Complete data were obtained for 15 subjects in the intervention team and 16 in the control team . Absolute error score , error of variation score and SEM were calculated and the results of the intervention and control teams were compared . Results : The proprioception sensory function of the players in the intervention team was significantly improved between the assessment s made at the start and the end of the season ( mean ( SD ) absolute error 9.78–8.21 ° ( 7.19–6.08 ° ) vs 3.61–4.04 ° (3.71–3.20 ° ) , p<0.05 ) . No improvement was seen in the sensory function in the control team between the start and the end of the season ( mean ( SD ) absolute error 6.31–6.22 ° (6.12–3.59 ° ) vs 6.13–6.69 ° (7.46–6.49 ° ) , p>0.05 ) . Conclusion : This is the first study to show that proprioception training improves the joint position sense in elite female h and ball players . This may explain the effect of neuromuscular training in reducing the injury rate The purpose of the present study was to investigate the effects of a soccer training session on the balance ability of the players and assess whether the effectiveness of a balance program is affected by its performance before or after the regular soccer training . Thirty-nine soccer players were r and omly divided into three subject groups ( n=13 each ) , one control group ( C group ) , one training group that followed a balance program ( 12 weeks , 3 times per week , 20 min per session ) before the regular soccer training ( TxB group ) , and one training group that performed the same balance program after the soccer training ( TxA group ) . St and ard testing balance boards and the Biodex Stability System were used to assess balance ability in the C , TxB , and TxA groups at baseline ( T0 ) and after completing the balance program ( T12 ) . The same tests and additional isokinetic knee joint moment measurements were carried out in the TxB and TxA groups pre- and post-soccer training . Two main results were obtained : ( 1 ) No differences ( p>0.05 ) were found in balance ability and knee joint moment production between pre- and post-soccer training . ( 2 ) The balance program increased ( p<0.01 ) the balance ability in the TxB and TxA groups , and the improvement in the TxA group was greater ( p<0.05 ) than that in the TxB group post-soccer training . Result ( 1 ) is in contrast to the notion of a link between fatigue induced by a soccer training session or game and injury caused by impaired balance , and result ( 2 ) has implication s for athletic training and rehabilitation The isolated effect of balance training on muscle strength of the flexors and extensors of the knee , without accompanying strength training , has not been addressed in the past . Effects of a balance training program alone were compared to a strength training program . Balance and strength training were performed by 15 persons each for 6 weeks including 12 training units of 25 min . Balance training was performed on instability training devices such as rolling board , mini trampoline and large rubber ball . The 15 persons of the strength training group trained on machines for leg curls and on leg presses for 25 min per unit . Measurements for balance were performed with one-leg balance on a narrow edge and a tilting stabilometer for 30 s ; maximum isometric strength was measured using an isokinetic device for each leg separately . The muscular balance between dominant and non-dominant leg was calculated . Strength gain was similar for the flexors and extensors in both groups . One-leg balance improved after balance training ( P < 0.01 ) with a 100 % increase over the strength training group ( P < 0.05 ) and the stabilometer test for each person in the balance ( P < 0.01 ) , but not in the strength training group . In the balance group the initial difference between right and left diminished . The results indicate balance training to be effective for gain in muscular strength , and secondly , in contrast to strength training , equalisation of muscular imbalances may be achieved after balance training Total sagittal knee laxity and postural control in the sagittal and frontal planes were measured in 25 patients at a mean of 36 months ( range , 27 to 44 ) after anterior cruciate ligament reconstruction and in a control group consisting of 20 uninjured age- and activity-matched subjects . Body sway was measured in the sagittal plane on a stable and on a sway-referenced force plate in single-legged stance , double-legged stance , or both , with the eyes open and closed . Postural reactions to perturbations in the sagittal and frontal planes were recorded in the single-legged stance with the eyes open . Total sagittal plane laxity was significantly greater in the anterior cruciate ligament-reconstructed knee ( 11.2 mm ; range , 6 to 15 ) than in the uninjured knee ( 8.9 mm ; range , 6 to 12 ) or in the control group ( 6.0 mm ; range , 5 to 8) . In spite of this , the patients , in comparison with the controls , exhibited normal postural control except in two variables — the reaction time and the latency between the start of force movement to maximal sway in the sagittal plane perturbations . This supports the hypothesis that rehabilitation , with proprioceptive and agility training , is an important component in restoring the functional stability in the anterior cruciate ligament-reconstructed knee Background Ankle sprains are the most common musculoskeletal injuries that occur in athletes , and they have a profound impact on health care costs and re sources . Hypothesis A balance training program can reduce the risk of ankle sprains in high school athletes . Study Design R and omized controlled clinical trial ; Level of evidence , 1 . Methods Seven hundred and sixty-five high school soccer and basketball players ( 523 girls and 242 boys ) were r and omly assigned to either an intervention group ( 27 teams , 373 subjects ) that participated in a balance training program or to a control group ( 28 teams , 392 subjects ) that performed only st and ard conditioning exercises . On-site athletic trainers recorded athlete exposures and sprains . Results The rate of ankle sprains was significantly lower for subjects in the intervention group ( 6.1 % , 1.13 of 1000 exposures vs 9.9 % , 1.87 of 1000 exposures ; P = . \n Output:\n " }, { "from": "agent", "value": "Balance training was effective in improving postural sway and functional balance when compared with untrained control participants .\nLarger effect sizes were shown for training programs of longer duration .\nAlthough controversial findings were reported for jumping performance , agility , and neuromuscular control , there are indications for the effectiveness of balance training in these outcomes .\nWhen compared with plyometric or strength training , conflicting results or no effects of balance training were reported for strength improvements and changes in sprint performance .\nCONCLUSIONS We conclude that balance training can be effective for postural and neuromuscular control improvements ." } ]

[ { "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 sole focus of models of insight on bio-medical perspectives to the complete exclusion of local , non-medical and cultural constructs m and ates review . This study attempted to investigate the impact of insight , psychopathology , explanatory models of illness on outcome of first episode schizophrenia . Method Patients diagnosed to have DSM IV schizophrenia ( n = 131 ) were assessed prospect ively for insight , psychopathology , explanatory models of illness at baseline , 6 , 12 and 60 months using st and ard instruments . Multiple linear and logistic regression and generalized estimating equations ( GEE ) were employed to assess predictors of outcome . Results We could follow up 95 ( 72.5 % ) patients . Sixty-five of these patients ( 68.4 % ) achieved remission . There was a negative relationship between psychosis rating and insight scores . Urban residence , fluctuating course of the initial illness , and improvement in global functioning at 6 months and lower psychosis rating at 12 months were significantly related to remission at 5 years . Insight scores , number of non-medical explanatory models and individual explanatory models held during the later course of the illness were significantly associated with outcome . Analysis of longitudinal data using GEE showed that women , rural residence , insight scores and number of non-medical explanatory models of illness held were significantly associated with BPRS scores during the study period . Conclusions Insight , the disease model and the number of non-medical model positively correlated with improvement in psychosis arguing for a complex interaction between the culture , context and illness variables . These finding argue that insight and explanatory models are secondary to psychopathology , course and outcome of the illness . The awareness of mental illness is a narrative act in which people make personal sense of the many challenges they face . The course and outcome of the illness , cultural context , acceptable cultural explanations and the prevalent social stigma interact to produce a complex and multifaceted underst and ing of the issues . This complexity calls for a nuanced framing of insight OBJECTIVES The authors used nationwide survey data to characterize current public conceptions related to recognition of mental illness and perceived causes , dangerousness , and desired social distance . METHODS Data were derived from a vignette experiment included in the 1996 General Social Survey . Respondents ( n = 1444 ) were r and omly assigned to 1 of 5 vignette conditions . Four vignettes described psychiatric disorders meeting diagnostic criteria , and the fifth depicted a \" troubled person \" with sub clinical problems and worries . RESULTS Results indicate that the majority of the public identifies schizophrenia ( 88 % ) and major depression ( 69 % ) as mental illnesses and that most report multicausal explanations combining stressful circumstances with biologic and genetic factors . Results also show , however , that smaller proportions associate alcohol ( 49 % ) or drug ( 44 % ) abuse with mental illness and that symptoms of mental illness remain strongly connected with public fears about potential violence and with a desire for limited social interaction . CONCLUSIONS While there is reason for optimism in the public 's recognition of mental illness and causal attributions , a strong stereotype of dangerousness and desire for social distance persist . These latter conceptions are likely to negatively affect people with mental illness 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 Based on experiences and empirical evidence gained in studies using the Lancashire Quality of Life Profile ( LQLP ) , the Manchester Short Assessment of Quality of Life ( MANSA ) has been developed as a condensed and slightly modified instrument for assessing quality of life . Its properties have been tested in a sample of community care patients . Method Fifty-five r and omly selected patients on the Care Programme Approach were interviewed using the LQLP , the MANSA and the Brief Psychiatric Rating Scale . Results Correlations between subjective quality of life scores on MANSA and LQLP were all 0.83 or higher ( 0.94 for the satisfaction mean score ) . Cronbach 's alpha for satisfaction ratings was 0.74 , and association with psychopathology was in line with results for LQLP as reported in the literature . Conclusions The MANSA is a brief instrument for assessing quality of life focusing on satisfaction with life as a whole and with life domains . Its psychometric properties appear satisfactory Background and aims : There is a dearth of data on the predictors of insight in schizophrenia . This study attempted to assess the predictors of insight in a cohort of first-episode schizophrenia followed up over 5 years . Methods : Patients diagnosed to have Diagnostic and statistical manual of mental disorders ( 4th ed . ; DSM-IV ) schizophrenia ( n = 131 ) were assessed prospect ively for insight , psychopathology and explanatory models of illness over a 5-year period using st and ard instruments . Multiple linear regression and generalized estimating equations ( GEE ) were employed to assess predictors of insight . Results : We could follow up 95 ( 72.5 % ) patients , 5 years after recruitment . A total of 65 of these patients interviewed at 60 months ( 68.4 % ) achieved remission . Cross-sectional evaluations suggest a relationship between insight , psychosis rating and explanatory models of illness with good insight and medical models associated with good outcome . However , baseline and early illness data do not predict insight scores at 5 years . Serial longitudinal assessment of insight is negatively associated with Brief Psychiatric Rating Scale ( BPRS ) scores and positively associated with the number of nonmedical explanatory models of illness held by patients . Conclusion : These findings argue that insight and explanatory models of illness are secondary to psychopathology , course and outcome . They are dependent on the trajectory of the person ’s illness , are not independent of the condition and call for multifaceted underst and ing of the issues \n Output:\n " }, { "from": "agent", "value": "There is an indication that causal explanations are associated with various treatment outcomes , including attitudes towards treatment and satisfaction with therapeutic relationships as well as internalized stigma .\nSpiritual beliefs appeared to be adopted as a coping mechanism and a way to reduce stigma but did not appear to be associated with treatment outcome .\nIndividuals with psychosis do appear to develop causal beliefs that may be associated with engagement with services and treatment , as well as impacting on their attitudes towards themselves and others with mental illness .\nThis may have important implication s for clinical practice .\nAn individual 's causal explanation may influence how they engage with services and treatment , as well as providing a way of coming to terms with their difficulties .\nCausal explanations may also contribute to the experience of stigma , which is often a significant barrier to recovery for this client group" } ]

[ { "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: Aminophylline and caffeine are commonly used for prophylaxis of apnea in premature infants . Previous studies have indicated different effects of the drugs on cerebral circulation . Therefore , we have compared the acute effects of bolus administration of caffeine citrate or aminophylline on left ventricular output , heart rate , blood pressure and global cerebral blood flow . The study group consisted of 33 newborn , spontaneously breathing , preterm infants r and omly assigned to receive either aminophylline 5mg/kg ( n= 19 ) or caffeine citrate 20mg/kg ( n= 14 ) . Two hours after iv drug administration , global cerebral blood flow measured by the Xe‐clearance technique was significantly lower after aminophylline than after caffeine ( mean(SD ) ) : 13.2 ( + 2.9/ ‐ 2.3 ) versus 17.2 ( + 7.1/ ‐ 5.1 ) ml/100 g/min ) ( p= 0.01 ) . There were no other statistically significant differences in circulatory or ventilatory parameters between the groups . Further studies are needed to clarify the clinical relevance of these results To determine if the use of oxygen in the delivery room influences subsequent global cerebral blood flow ( CBF ) , 70 infants of gestational age of less than 33 completed weeks were r and omly assigned to receive room air ( group I ) or 80 % oxygen ( group II ) during the initial stabilisation at birth . In group I supplemental oxygen was administered on clinical indications , when required . After being admitted to the neonatal intensive care unit all infants were treated according to our normal practice . At a postnatal age of 2 hours CBF was measured by xenon clearance . Seventy four per cent of the infants in group I were successfully stabilised without the need for supplemental oxygen . CBF was significantly higher in group I than in group II ( CBF median ( interquartile range ) : 15.9 ( 13.6 - 21.9 ) v 12.2 ( 10.7 - 13.8 ) ml/100 g/minute ) . Differences in oxygen exposure seemed to be the only explanation for the differences in CBF . No differences in short term outcome were found between the groups OBJECTIVE To investigate the effects on oxygenation of targeting the higher versus the lower end of the currently recommended range for pulse oximetry ( Spo2 ) . DESIGN Nonr and omized crossover trial with the use of within-subject comparisons ( two-tailed paired t test ) . SETTING Level III neonatal intensive care unit of a university hospital . PATIENTS Twenty infants whose lungs were mechanically ventilated ( mean + /- SD : birth weight , 1192 + /- 396 gm ; gestational age , 28.7 + /- 2.7 weeks ; age at time of study , 42 + /- 26 hours ) . INTERVENTIONS The inspired oxygen concentration was adjusted to achieve Spo2 readings of 93 % to 96 % versus 89 % to 92 % ( Ohmeda pulse oximeter ) or 95 % to 98 % versus 91 % to 94 % ( Nellcor oximeter ) . MEASUREMENTS Cardiac output was measured by echocardiography , oxygen content of arterial blood sample s by cooximetry , and oxygen consumption by indirect calorimetry . RESULTS The inspired oxygen concentrations required to achieve the Spo2 target ranges were 39.8 % + /- 8.3 % versus 28.7 % + /- 6.1 % ( p < 0.001 ) . The respective arterial oxygen contents were 18.0 + /- 2.6 ml/dl versus 16.9 + /- 2.5 ml/dl ( p < 0.001 ) . Oxygen consumption was unchanged . In the lower-oxygen condition no compensatory increase in cardiac output was detected ; thus the estimated mixed venous oxygen tension decreased and the oxygen extraction ratio increased . Venous admixture increased from 15 % + /- 6 % to 31 % + /- 9 % in the lower-oxygen condition ( p < 0.001 ) . CONCLUSIONS The \" low normal \" Spo2 target range allowed for less oxygen exposure . No signs of mismatch between systemic oxygen delivery and dem and could be detected Sleep fragmentation , decreased rapid eye movement ( REM ) sleep time , and REM sleep hypoxemia have been reported in infants with chronic neonatal lung disease ( CNLD ) in early infancy despite an awake hemoglobin oxygen saturation ( SaO2 ) > 93 % . Interestingly , higher inspired O2 concentrations have been demonstrated to reduce REM sleep fragmentation in CNLD patients in middle infancy . However , the effect of increased SaO2 on sleep architecture in infants with CNLD near the time of discharge from neonatal intensive care has not been reported . We performed paired overnight polysomnography in a sleep laboratory on 16 infants with CNLD ( 4 weeks median corrected age ) in air or their usual inspired oxygen ( SaO2 > 93 % ) and again when receiving 0.25 L/min higher than baseline inspired oxygen via nasal catheters ( SaO2 > 97 % ) . A control group of seven healthy preterm infants was similarly studied . For CNLD infants on supplemented O2 , sleep duration decreased by 15 % ( 422+/-66 min vs. 359+/-89 min ; P < 0.005 ) , and sleep efficiency decreased by 7 % ( 73.2+/-10.6 % vs. 66.4+/-14.0 % ; P < 0.005 ) but percentage of time in REM sleep ( REM% ) ( 31.5+/-8.9 % vs. 29.8+/-8.6 % ; P=0.560 ) , REM epoch duration ( 12.4+/-2.8 min vs. 13.4+/-4.3 min ; P=0.420 ) , and REM arousal index ( 18.6+/-6.5 vs. 18.8+/-7.2 ; P=0.990 ) were not significantly affected . Conversely , higher O2 did not alter sleep architecture in the control group . The mean non-REM ( NREM ) respiratory rate decreased ( CNLD : P=0.003 ; controls : P=0.02 ) , NREM SaO2 increased ( P < 0.05 ) , although the mean transcutaneous CO2 was unaltered in both CNLD and control groups . This study confirmed low REM% in CNLD infants in early infancy and demonstrated that a higher SaO2 adversely affected sleep time but did not influence REM sleep duration or arousal frequency . A target SaO2 > 93 % is , therefore , as efficacious as an SaO2 > 97 % in optimizing sleep architecture in CNLD infants A previous report has shown no difference between the clinical outcome of infants exposed to a high oxygen ( O2 ) regimen and those exposed to a low O2 regimen for the treatment of respiratory distress syndrome ( RDS ) . Mechanical ventilation was not used in either group . In the present study , pulmonary function tests were performed on 14 survivors receiving the low O2 regimen ( low O2 group ) and on nine receiving the high O2 regimen ( high O2 group ) ten years after their initial illness . Similar evidence of abnormalities of large airways was found in both groups of prematurely born children that was comparable with that previously reported for normal prematurely born children . There was evidence in the high O2 group similar to that reported for ventilated survivors with RDS exposed to a high concentration of O2 . From these data , it was concluded that neonatal exposure to high O2 concentrations in the absence of mechanical ventilation is capable of causing long-term change in small airways This study was performed to determine whether the use of continuous transcutaneous oxygen tension ( tcPO2 ) monitoring could reduce the incidence of retinopathy of prematurity in preterm infants receiving oxygen therapy . A total of 296 infants with birth weights less than or equal to 1,300 g were r and omly assigned to a continuous monitoring or a st and ard care group . Infants in the continuous monitoring group had tcPO2 monitored continuously as long as they required supplemental oxygen , and infants in the st and ard care group had tcPO2 monitored only during the more acute state of their illness . Management of both groups was otherwise identical . Of 148 infants in the continuous monitoring group , 101 survived ; of the 148 patients in the st and ard care group , 113 survived . Mean birth weights and gestational ages were similar for both groups . Duration of mechanical ventilation and oxygen therapy was also similar . The overall incidence of retinopathy of prematurity was 51 % in the continuous monitoring group and 59 % in the st and ard care group . As birth weight for infants greater than or equal to 1,000 g increased , a higher risk of retinopathy of prematurity developing was noted in the st and ard care group . Cicatricial retinopathy of prematurity developed in four infants in the continuous monitoring group and five in the st and ard care group . These results suggest that continuous tcPO2 monitoring may reduce the incidence of retinopathy of prematurity in infants with birth weights greater than 1,000 g but not in the smaller infants in whom this complication occurs more frequently and is more severe Between 1966 and 1970 , infants with birthweights between 1000 and 1500 g entered a r and omized controlled trial to determine the short‐term and long‐term results of neonatal intensive care . Of 158 long‐term survivors , five were lost to follow‐up , but the multidisciplinary research team prospect ively followed 143 children up to the age of eight years . Useful data were available for the other 10 children . Of the long‐term survivors 74 had received routine , and 84 had received intensive nursery care Oxygen saturation determined by pulse oximetry was monitored in 152 pediatric surgical patients divided into two groups . In one group , the oximeter data and alarms were available ( N = 76 ) to the anesthesia team , and , in the other group , these data were unavailable ( N = 76 ) . A trained observer recorded all intraoperative hypoxic episodes and informed the anesthesia team of all major events ( i.e. , oxygen saturation less than or equal to 85 % for greater than or equal to 30 s ) ( PaO2 approximately 52 mmHg ) . Thirty-five major events occurred : 24 in the unavailable group , and 11 in the available group ( P = 0.021 ) . A greater number of major events occurred in children less than or equal to 2 yr of age ( P = 0.013 ) . Hypoxic events diagnosed by the oximeter , but not by the anesthesiologist , were more frequent in the unavailable group ( 13 ) than in the available group ( 5 ) ( P = 0.0495 ) . ASA Physical Status 3 and 4 patients were more likely to suffer a major event ( P = 0.009 available , 0.006 unavailable ) . The pulse oximeter diagnosed hypoxemia before the signs and symptoms of hypoxemia were apparent ( i.e. , prior to observed cyanosis or bradycardia ) . Major hypoxic events were unrelated to duration of anesthesia . Major events were evenly distributed among induction , maintenance , and awakening from anesthesia ; a greater number of hypoxic events occurred during induction in the unavailable group ( P = 0.031 ) . No morbidity was documented in any patient who suffered an hypoxic event . ( ABSTRACT TRUNCATED AT 250 WORDS The relation between PaO2 and retrolental fibroplasia ( RLF ) was studied prospect ively in 719 premature infants born in or treated in the intensive care units of a group of university hospitals . Blood gas studies were performed on 589 of these infants , 66 of whom had a diagnosis of RLF ; in 27 of these 66 , some grade of mostly nonblinding cicatricial disease developed . The frequency of RLF was highest among infants of lowest birth weight . A multivariate statistical method was used to analyze simultaneously the effect of possible etiologic factors associated with RLF . The occurrence of RLF was found to be unrelated to PaO2 , as determined by the limited information available from intermittent sampling . RLF is associated with concentration of oxygen administered in the lightest birth weight group , but the strongest association , aside from birth weight , was with time in oxygen . None of the other variables involving blood chemical values appeared to be associated with RLF . The severity of cicatricial RLF is clearly greater in infants weighing less than 1,200 g at birth . Conservative administration of oxygen may have been responsible for failure to demonstrate quantitative association between PaO2 levels and disease . Agreement between the observed and predicted numbers of infants with RLF demonstrate the strength of the multivariate technique employed in making the statistical analyses AIMS : To determine if decreasing arterial blood saturation from 95 % to 90 % could cause vasoconstriction of the pulmonary vasculature and dilatation of a patent ductus arteriosus in preterm newborn infants with respiratory distress syndrome ( RDS ) . METHODS : Doppler echocardiographic studies were compared at 95 % and 90 % pulse oxygen saturation ( SpO2 ) in 13 preterm infants aged 61.7 ( 4.3 ) hours with RDS and Doppler echocardiographic evidence of tricuspid regurgitation . RESULTS : The mean (SD)Doppler echocardiographic indices \n Output:\n " }, { "from": "agent", "value": "The one trial that specifically addressed the question of lower versus higher PaO2 found no effect on death , but did not report ( in sufficient detail to warrant inclusion ) the effect of this intervention on eye or other outcomes .\nREVIEW ER 'S CONCLUSIONS The results of this meta- analysis confirm the commonly held view of today 's clinicians that a policy of unrestricted , unmonitored oxygen therapy has potential harms , without clear 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: BACKGROUND Low albumin level is a strong predictor of mortality and morbidity among hemodialysis patients , yet few interventions are available to improve albumin levels . Moreover , the relative importance of nutritional barriers versus inflammation in contributing to hypoalbuminemia is unclear . We sought to determine whether targeting specific nutritional barriers will improve albumin levels . METHODS We conducted a r and omized controlled trial involving 180 patients with baseline albumin levels less than 3.7 g/dL ( < 37 g/L ) at 44 long-term hemodialysis facilities . Study coordinators identified and intervened on specific barriers present among intervention patients , whereas control patients continued to receive the usual care . Barriers targeted included poor nutritional knowledge , poor appetite , help needed with shopping or cooking , low fluid intake , inadequate dialysis dose , depression , difficulty chewing , difficulty swallowing , gastrointestinal symptoms , and acidosis . RESULTS At baseline , intervention and control patients had similar albumin levels , dietary intakes , levels of inflammatory markers , and numbers of nutritional barriers . After 12 months , intervention patients had greater increases in albumin levels compared with control patients ( + 0.21 versus + 0.06 g/dL [ + 2.1 versus + 0.6 g/L ] ; P < 0.01 ) , as well as greater increases in energy intake ( + 4.1 versus -0.6 Kcal/d/kg ; P < 0.001 ) and protein intake ( + 0.13 versus -0.06 g/d/kg ; P < 0.001 ) . The intervention appeared most effective for barriers related to poor nutritional knowledge , help needed with shopping or cooking , and difficulty swallowing . About half the subjects had elevated levels of inflammatory markers , but there was no relationship between change in levels of albumin and inflammatory markers . CONCLUSION A nutrition intervention tailored to patient-specific barriers result ed in modest improvements in albumin levels regardless of levels of inflammatory markers BACKGROUND Compared with in-center hemodialysis , self-care dialysis ( including home and self-care hemodialysis and peritoneal dialysis ) is less re source intensive and associated with similar clinical outcomes . However , utilization of self-care dialysis has been very low . We performed a r and omized controlled trial in predialysis patients with chronic kidney disease ( CKD ) ( GFR < 30 mL/min ) to determine the impact of a patient-centered educational intervention on patients ' intention to initiate dialysis with self-care dialysis . METHODS Seventy patients with CKD who were receiving care in a multidisciplinary predialysis clinic were r and omized to receive either ( 1 ) a two-phase patient-centered educational intervention ( phase 1 included educational booklets and a 15-minute video on self-care dialysis ; phase 2 included a 90-minute small group interactive educational session on self-care dialysis ) in addition to their regular multidisciplinary care , or ( 2 ) ongoing st and ard care and education in the multidisciplinary predialysis clinic . The primary outcome was patients ' intention to initiate dialysis with self-care dialysis , assessed by question naire . RESULTS Thirty-five patients were r and omized to st and ard care ; 34 completed the study . Thirty-five patients were r and omized to the educational intervention ; 30 completed phase 1 and 28 completed phase 2 . By study end , significantly more patients in the intervention group ( 82.1 % ) intended to start dialysis with self-care dialysis compared with the st and ard care group ( 50 % , P= 0.015 ) . This difference persisted after controlling for the small baseline differences among patients in the two study groups ( P= 0.004 ) . CONCLUSION A two-phase educational intervention can increase the proportion of patients who intend to initiate dialysis with self-care dialysis Purpose The purpose of the study is to investigate the effect of an emotional intelligence program on the health-related quality of life and well-being of individuals with type 2 diabetes . Methods The BarOn Emotional Intelligence Scale ( EQ-I ) , WHO Well-Being Question naire ( WHO-WBQ-22 ) , WHO Quality of Life Measure ( WHOQOL-Bref ) , and the Medical Outcomes Study 36-Item Health Survey ( SF-36 ) were administered to 184 patients with type 2 diabetes who volunteered to participate . Thirty-six patients with the lowest test scores on the WHO-WBQ-22 , WHOQOL-Bref , and SF-36 were r and omized into study and control groups ( 18 patients each ) . A 12-week emotional intelligence program was administered to the study group . At the end of the program , scales were readministered to both groups and again at 3 and 6 months . Results There were no differences between the quality of life , well-being , and emotional intelligence levels of the study and control groups before the commencement of the program ( P > .05 ) . At the conclusion of the program , quality of life , well-being , and emotional intelligence levels of study group patients increased in comparison with those in the control group ( P < .001 ) . The positive effect of the program on study groups ' quality of life , wellbeing , and emotional intelligence persisted at the 3- and 6-month follow-up . Conclusion The emotional intelligence program may have positive effects on quality of life and well-being of individuals with type 2 diabetes A nurse-delivered haemodialysis patient education programme incorporating cognitive behavioural therapy ( CBT ) was developed . The effects of the CBT programme were compared with those of a st and ard patient education ( SPE ) programme on patients ' salt intake and weight gain using a quasi-experimental design . There were 22 participants ( 11 CBT , 11 SPE ) undergoing outpatient haemodialysis therapy at one clinic . Daily weight gain rates decreased in the intervention period compared with the baseline period in both the CBT and SPE groups . This effect lasted for 12 weeks in the CBT group but for only eight weeks in the SPE group . In addition , daily salt intake decreased in the intervention period compared with the baseline period in both the CBT and SPE groups , persisting for 12 weeks . From these results , both programmes were shown to be effective , but CBT had a longer effect OBJECTIVES We investigated the effect of achieved continuous tight blood pressure control and intensified insulin therapy on the rate of progression of renal failure in patients with overt diabetic nephropathy and already impaired renal function . DESIGN AND SETTING Prospect i ve , r and omized , multicentre , follow-up study . PATIENTS AND INTERVENTIONS From a screened group of the 66 hypertensive type 1 diabetic patients ( IDDM ) with overt diabetic nephropathy and reduced glomerular filtration rate who participated in two intensified treatment programmes , 39 patients fulfilled the study inclusion criteria and were enrolled into the 2-year follow-up period . The choice of antihypertensive drugs was based on a r and omized allocation to open antihypertensive treatments starting with felodipine , metoprolol , or ramipril . OUTCOME MEASURES Progression of renal failure was assessed by measurement of glomerular filtration rate ( GFR ) on insulin clearance every 6 months . MAIN RESULTS During the study period mean HbA1c was 8.1 + /- 1.6 % and the office blood pressure 143 + /- 14/88 + /- 8 mmHg . The change in GFRinulin ( mean and 95 % CI ) was + 1.9 ( -2.2 ; + 6.1 ) ml/min/year . GFR improved in 51 % , deteriorated in 39 % , and remained stable in 10 % of the patients . CONCLUSION This study shows that stabilization of glomerular filtration rate , as assessed by inulin clearance , is possible in patients with overt diabetic nephropathy who reach the goals of intensified antihypertensive treatment even if kidney function is already impaired Aims To examine whether motivating patients to gain expertise and closely follow their risk parameters will attenuate the course of microvascular and cardiovascular sequelae of diabetes AIMS This paper reports a study investigating the effectiveness of an adaptation training programme ( ATP ) to help patients with end-stage renal disease ( ESRD ) to cope with illness-related stresses and , thus , to alleviate depression and improve quality of life . BACKGROUND Patients with ESRD who receive dialysis must confront the burdens of long-term illness and numerous treatment-associated stressors . The ability of these patients to cope with and adapt to these stresses , whether related to their medical regimen or to the dem and s of daily life , has an important influence on physical and psychological well-being . METHODS The study was a r and omized controlled trial using a convenience sample of 57 eligible , fully informed and consenting patients with ESRD who were assigned to experimental ( ATP plus usual care ) or control ( usual care ) groups . Participants in the ATP took part in weekly small group sessions over an 8-week period and monthly follow-up to help them to cope with stressors . A clinical nurse specialist and an experienced psychotherapist led them in three small groups ( 8 - 10 per group ) . Participants in the usual care group received routine care . Instruments comprised the Haemodialysis Stressor Scale , Beck Depression Inventory and Medical Outcomes Study SF-36 . Data were collected at baseline and at three months following the intervention . RESULTS The major stressors for these patients were limitations on time and place related to employment , limitations on fluid intake , transport difficulties , loss of bodily function , length of dialysis treatment , and limitation of physical activities . The ATP had a beneficial effect on perceived stress ( P = 0.005 ) , depression ( P = 0.001 ) and quality of life ( P = 0.02 ) 3 months after the intervention . CONCLUSIONS This study supports the effectiveness of an ATP to decrease stress and depression levels , and to improve the quality of life of ATP patients receiving haemodialysis BACKGROUND Self-care dialysis ( SCD ) is associated with cost savings and possibly improved quality of life compared to in-centre haemodialysis . Despite this , less than one in four dialysis patients are currently treated with SCD . Our objectives were to identify perceived advantages of SCD associated with increased odds of selecting SCD , and to evaluate the effect of an educational intervention on patients ' perceptions of these advantages . METHODS We r and omized patients with GFR<30 ml/min to st and ard pre-dialysis education or a multifaceted educational intervention . After each component of the intervention , participants completed a question naire on which they identified advantages of SCD and indicated their preferred dialysis modality . We used inductive coding to identify perceived advantages of SCD . RESULTS Seventy patients participated in the study . We identified three advantages of SCD : freedom , lifestyle and control . Of these , freedom and lifestyle were associated with increased odds of selecting SCD [ OR 9.1 ( 2.0 , 41.3 ) and 7.0 ( 1.6 , 29.7 ) , respectively ] . We combined these advantages for receiver-operating characteristic ( ROC ) analysis to assess accuracy in predicting patients ' intended choice of dialysis . The area under the ROC curve was 0.82 ( 0.70 , 0.93 ) . Patients who received the educational intervention were more likely to perceive freedom and control as advantages , and were less likely to identify no advantages of SCD . CONCLUSION Patients who identify freedom and lifestyle advantages of SCD are more likely to choose SCD . Providing additional education on dialysis modalities increases patients ' perceptions of the advantages of SCD and the odds of them selecting SCD BACKGROUND Intensified multifactorial intervention - with tight glucose regulation and the use of renin-angiotensin system blockers , aspirin , and lipid-lowering agents - has been shown to reduce the risk of nonfatal cardiovascular disease among patients with type 2 diabetes mellitus and microalbuminuria . We evaluated whether this approach would have an effect on the rates of death from any cause and from cardiovascular causes . METHODS In the Steno-2 Study , we r and omly assigned 160 patients with type 2 diabetes and persistent microalbuminuria to receive either intensive therapy or conventional therapy ; the mean treatment period was 7.8 years . Patients were subsequently followed observationally for a mean of 5.5 years , until December 31 , 2006 . The primary end point at 13.3 years of follow-up was the time to death from any cause . RESULTS Twenty-four patients in the intensive-therapy group died , as compared with 40 in the conventional-therapy group ( hazard ratio , 0.54 ; 95 % confidence interval [ CI ] , 0.32 to 0.89 ; P=0.02 ) . Intensive therapy was associated with a lower risk of death from cardiovascular causes ( hazard ratio , 0.43 ; 95 % CI , 0.19 to 0.94 ; P=0.04 ) and of cardiovascular events ( hazard ratio , 0.41 ; 95 % CI , 0.25 to 0.67 ; P<0.001 ) . One patient in the intensive-therapy group had progression to end-stage renal disease , as compared with six patients in the conventional-therapy group ( P=0.04 ) . Fewer patients in the intensive-therapy group required retinal photocoagulation ( relative risk , 0.45 ; 95 % CI , 0.23 to 0.86 ; P=0.02 ) . Few \n Output:\n " }, { "from": "agent", "value": "AUTHORS ' CONCLUSIONS Education programmes appear to have beneficial effects on improving patients ' knowledge of diabetes and some self-management behavioural changes for patients with diabetes on dialysis or with microalbuminuria .\nEducational programmes appear to have beneficial effects on improving patients ' self-efficacy and result in some beliefs changes for patients with diabetes and microalbuminuria .\nThere is , therefore , inadequate evidence to support the beneficial effects of education programmes for people with DKD" } ]

[ { "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 S-1 or capecitabine plus oxaliplatin are considered active and tolerable in gastric cancer patients . We conducted a r and omized phase II trial in gastric cancer patients to compare the activity and safety of these combinations . METHODS The patients received S-1 at 80 mg/m2 for 14 days , followed by a 7-day rest period within a 3-week schedule in the S-1/oxaliplatin ( SOX ) arm , and capecitabine at 2000 mg/m2 for 14 days , followed by a 7-day rest period within a 3-week schedule in the capecitabine/oxaliplatin ( CAPOX ) arm . Oxaliplatin 130 mg/m2 was administered every 3 weeks in both arms . RESULTS One hundred twenty-nine patients were r and omly assigned to SOX ( N=65 ) or CAPOX ( N=64 ) . The median time to progression and the overall survival were 6.2 and 12.4 months with SOX , respectively ; and 7.2 and 13.3 months with CAPOX , respectively . The overall response rates were 40 % and 44 % for SOX and CAPOX , respectively . The most frequent grade 3 or 4 toxicities were thrombocytopenia ( 15.4 % ) for SOX and neutropenia ( 18.8 % ) for CAPOX . The median time to 10 % deteriorations in global health scores was similar in both arms ( SOX , 4.3 months , CAPOX , 4.9 months ) . CONCLUSION Both the SOX and CAPOX regimens were equally active and well tolerated in advanced gastric cancer patients Objectives : To evaluate the efficacy and safety of capecitabine in patients with advanced or recurrent gastric cancer , we conducted a pilot phase II study in Japan . Methods : Patients with advanced or recurrent gastric cancer were given oral capecitabine 828 mg/m2 twice daily for 3 weeks , followed by 1 week of no treatment . Two or more cycles were administered . From July 1996 to December 1997 , 32 patients were enrolled in the study . The response to capecitabine was evaluated in 31 patients , excluding 1 found to be ineligible . Results : The overall response rate was 19.4 % ( 6/31 , 95 % confidence interval : 7.5–37.5 % ) . The median duration of response was 124.5 days , the median time to disease progression 85.0 days , and the median survival time 247.5 days . Drug-related adverse events of grade 3 or higher were infrequent : in 2 patients ( 6.3 % ) total bilirubin concentration increased , and 1 patient ( 3.1 % ) each had elevation of GOT , anemia , lymphopenia , increased creatinine , and h and -foot syndrome . No patient had gastrointestinal toxicity of grade 3 or higher . Conclusion : Capecitabine was suggested to be safe and effective in the treatment of advanced or recurrent gastric cancer . Further phase II studies of capecitabine on a large scale are warranted A phase III r and omised study , comparing treatment with fluorouracil , epidoxorubicin and methotrexate ( FEMTX ) with the best supportive care , was conducted in patients with unresectable or metastatic gastric cancer . During the period from July 1986 to June 1992 , 41 patients were r and omised to receive FEMTX or best supportive care . MTX was given in a dose of 1500 mg m-2 intravenously ( i.v . ) followed after 1 h by 5-FU 1500 mg m-2 i.v . on day 1 ; leucovorin rescue was started after 24 h ( 30 mg orally every 6 h for 48 h ) and epidoxorubicin 60 mg m-2 i.v . was administered on day 15 . In addition both groups received tablets containing vitamins A and E. Response rates for FEMTX were as follows : complete response ( CR ) , 19 % ( 4/21 ) ; partial response ( PR ) , 10 % ( 2/21 ) ; no change ( NC ) , 33 % ( 7/21 ) ; and progressive disease ( PD ) , 24 % ( 5/21 ) . Response rates in the control group were : NC , 20 % ( 4/20 ) ; and PD , 80 % ( 16/20 ) . Increased pain was observed in one patient in the treated group and in 11 patients in the control group within the first 2 months . WHO grade III/IV toxicity in the chemotherapy group was as follows : nausea/vomiting 40 % , diarrhoea 10 % , stomatitis 15 % , leucopenia 50 % and thrombocytopenia 10 % . One possible treatment-related death was due to sepsis . The median time to progression in the FEMTX group was 5.4 months [ 95 % confidence interval ( CI ) 3.1 - 11.7 months ] , but only 1.7 months in the control group ( 95 % CI 1.2 - 2.7 months ) ( P = 0.0013 ) . Similarly , the FEMTX group displayed significantly ( P = 0.0006 ) prolonged survival compared with the control group , i.e. median survival 12.3 months ( 95 % CI 7.1 - 15.6 months ) vs 3.1 months ( 95 % CI 1.6 - 4.6 months ) . In conclusion , FEMTX combined with vitamin A and E is a fairly well-tolerated treatment , giving a response rate of 29 % in patients with advanced gastric cancer , and also prolonging patients ' survival . It can be used as a reference treatment in testing new investigational combinations BACKGROUND This study aim ed to evaluate the safety and efficacy of oral fluoropyrimidines and cisplatin therapy in elderly patients with untreated advanced gastric cancer ( AGC ) retrospectively . In addition , we evaluated the relative activity and toxicity of these agents in this patient population . METHODS Clinical data from 72 patients with previously untreated AGC , who were treated with capecitabine/cisplatin and S-1/cisplatin , were review ed . Oral fluoropyrimidines were administered orally twice a day on Days 1 - 14 . The dose of capecitabine was 1250 mg/m(2 ) and that of S-1 was 50 mg [ body surface area ( BSA ) < 1.5 m(3 ) ] or 60 mg ( BSA > 1.5 m(3 ) ) twice a day . Cisplatin was administered intravenously on Day 1 ( before the first dose of capecitabine or S-1 ) at a dose of 70 mg/m(2 ) over a 2 h period . The chemotherapy cycle was of 3 weeks ( with oral capecitabine or S-1 ) . RESULTS Thirty-two and 40 patients received the S-1 and capecitabine regimens , respectively , and were included in the analysis . The S-1 protocol had a response rate of 40.6 % , a median time-to-progression ( TTP ) of 5.4 months and a median survival of 9.6 months . The capecitabine had a response rate of 55 % , a median TTP of 5.9 months and a median survival of 10.2 months . Each protocol had a similar incidence of Grade 3 or 4 adverse events . However , there was a higher rate of the h and -foot syndrome ( 6 versus 37 % ) and diarrhea ( 25 versus 32 % ) in the capecitabine group . CONCLUSION Oral fluoropyrimidines and cisplatin in elderly patients with untreated AGC showed encouraging results . The treatment was well tolerated with a manageable toxicity profile . The comparison of S-1 with capecitabine showed that capecitabine had a slightly higher response rate ( statistically not significant ) in addition to a higher rate of adverse events such as the h and -foot syndrome and diarrhea . These data should be warranted with further prospect i ve studies Background . In an attempt to decrease the toxic effects of fluorouracil , doxorubicin , and methotrexate ( FAMTX ) by reducing the dose of methotrexate from 1500 mg/m2 , according to the original regimen , to 1000 mg/m2 , the authors design ed the modified FAMTX treatment that was evaluated in a prospect i ve Phase II‐III r and omized trial Purpose S-1 is a fourth-generation oral fluoropyrimidine that was developed to mimic the effects achieved with protracted continuous infusion of 5-fluorouracil ( 5-FU ) . This phase II study evaluated the efficacy and safety of S-1 salvage chemotherapy in patients with paclitaxel- and cisplatin-refractory gastric cancer . The primary end point was progression-free survival ; secondary end points were overall survival , safety , and clinical benefit . Methods Patients were eligible for the study if they had histologically documented gastric adenocarcinoma previously treated with paclitaxel and cisplatin , age ≥ 18 years , Eastern Clinical Oncology Group performance status ≤2 , adequate organ function , and no evidence of gastrointestinal obstruction or passage disturbance . Patients were treated with a dose of S-1 based on body surface area ( BSA ) as follows : BSA < 1.25 m2 , 80 mg/day ; 1.25 ≤ BSA < 1.5 m2 , 100 mg/day ; BSA ≥ 1.5 m2 , 120 mg/day . The total dose was divided in two and administered twice daily for 4 weeks followed by a 2-week rest period . Results Of the 53 patients enrolled in this study , 49 were evaluable . A total of 190 chemotherapy cycles were administered , and the median number of cycles was 2 . Five patients ( 9.4 % ) had a partial response , and 18 ( 34 % ) had stable disease . Median progression-free survival and overall survival were 4.9 and 10.4 months , respectively . Grade 3/4 hematological toxicities included neutropenia in six patients ( 11 % ) but no cases of febrile neutropenia were found . Most of the non-hematological toxicities were diarrhea , asthenia , and mucositis , but none reached grade 3 or grade 4 in severity . Improvement of pain was observed in 17 patients ( 32.1 % ) . Conclusions S-1 monotherapy provides active and safe salvage chemotherapy for patients with advanced gastric cancer who have been previously treated with paclitaxel and cisplatin PURPOSE To investigate the side effects , determine the maximum-tolerated dose ( MTD ) , and study the pharmacokinetics of S-1 , an oral fluoropyrimidine-based antineoplastic agent consisting of the fluorouracil ( 5-FU ) prodrug tegafur combined with two modulators , 5-chloro-2,4-dihydroxypyridine and potassium oxonate . PATIENTS AND METHODS Patients with advanced solid tumors received S-1 bid for 28 days , followed by 1 week of rest . 5-FU pharmacokinetics were investigated after a single initial dose of S-1 during the first 24 hours and weekly thereafter . RESULTS Twenty-eight patients received S-1 at the four consecutive dose levels of 25 , 45 , 35 , and 40 mg/m(2 ) . The MTD was initially found at 45 mg/m(2 ) , with diarrhea as the dose-limiting toxicity ( DLT ) . Diarrhea was also the DLT at the dose of 40 mg/m(2 ) , which was the MTD for patients exposed to extensive prior chemotherapy . Other toxicities were generally mild . Two patients had a reduction of more than 50 % in tumor dimension . Plasma pharmacokinetics of 5-FU were linear ; at the highest S-1 dose level , 5-FU plasma peak concentrations reached 1 to 2 micromol/L , and the half-life of 5-FU was 3 to 4 hours . A statistically significant relationship was observed between the severity of diarrhea and pharmacokinetic parameters of 5-FU . CONCLUSION The recommended dose of S-1 in chemotherapy-naive or minimally chemotherapy-exposed patients is 40 mg/m(2 ) bid on 28 consecutive days , every 5 weeks . In heavily pretreated patients , the recommended dose is 35 mg/m(2 ) bid . Phase II trials are warranted in tumors known to be responsive to 5-FU treatment OBJECTIVE To observe the efficacy and safety of chemotherapy regimens oxaliplatin combined with capecitabine ( CAPOX ) or oxaliplatin combined with tegafur , gimeracil and oteracil potassium capsules (S-1)(SOX ) , and to investigate the value of expression of thymidine phosphorylase ( TP ) and dihydropyrimidine dehydrogenase ( DPD ) proteins in tumor tissue for predicting the efficacy of CAPOX and SOX regimens in advanced gastric cancer patients . METHODS A total of 107 newly-diagnosed , stage Ⅲc/Ⅳ gastric \n Output:\n " }, { "from": "agent", "value": "Conclusion This systematic review showed that for Asian patients , Cap shows superiority in ORR but not 1-year OS or PFS , and it will increase the risk of all- grade HFS and neutropenia .\nUntil now , S-1 containing treatment might be a better choice for advanced gastric 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: We evaluated the efficacy of LifeWindows , a theory-based , computer-administered antiretroviral ( ARV ) therapy adherence support intervention , delivered to HIV + patients at routine clinical care visits . 594 HIV + adults receiving HIV care at five clinics were r and omized to intervention or control arms . Intervention vs. control impact in the intent-to-treat sample ( including participants whose ARVs had been entirely discontinued , who infrequently attended care , or infrequently used LifeWindows ) did not reach significance . Intervention impact in the On Protocol sample ( 328 intervention and control arm participants whose ARVs were not discontinued , who attended care and were exposed to LifeWindows regularly ) was significant . On Protocol intervention vs. control participants achieved significantly higher levels of perfect 3-day ACTG-assessed adherence over time , with sensitivity analyses maintaining this effect down to 70 % adherence . This study supports the utility of LifeWindows and illustrates that patients on ARVs who persist in care at clinical care sites can benefit from adherence promotion software . ResumenEvaluamos la eficacia de LifeWindows , una intervención de apoyo para la adherencia a la terapia antirretroviral ( TAR ) basada en teoría y con administración informatizada para pacientes con VIH + en sus visitas clínicas rutinarias . 594 adultos de cinco clínicas con VIH + y bajo tratamiento fueron aleatoriamente asignados a un grupo de intervención o de control . No se alcanzó significación estadística al comparar ambos grupos bajo la estrategia de ‘ intención de tratar ’ ( incluyendo los participantes cuyos TAR se habían interrumpido por completo , habían asistido a la clínica en pocas ocasiones , o usaron LifeWindows con poca frecuencia ) . Sin embargo , la intervención obtuvo un impacto significativo cu and o se evaluó con la muestra bajo Protocol o ( un total de 328 participantes cuyos TAR no fueron interrumpidos , asistieron a sus visitas clínicas y se expusieron a LifeWindows regularmente ) . Los participantes bajo Protocol o de intervención obtuvieron niveles más altos de adherencia que el grupo control en tres días de Estudios de Grupos Clinicos con SIDA ( EGCS ) con repetidas evaluaciones y manteniendo como mínimo un 70 % de la adherencia . Este estudio apoya la utilidad de LifeWindows e indica que los pacientes con TAR que asisten a las visitas clínicas , pueden beneficiarse de este software de promoción de la adherencia Background Human re source limitations are a challenge to the delivery of antiretroviral therapy ( ART ) in low-re source setting s. We conducted a cluster r and omized trial to assess the effect of community-based peer health workers ( PHW ) on AIDS care of adults in Rakai , Ug and a. Methodology /Principal Findings 15 AIDS clinics were r and omized 2∶1 to receive the PHW intervention ( n = 10 ) or control ( n = 5 ) . PHW tasks included clinic and home-based provision of counseling , clinical , adherence to ART , and social support . Primary outcomes were adherence and cumulative risk of virologic failure ( > 400 copies/mL ) . Secondary outcomes were virologic failure at each 24 week time point up to 192 weeks of ART . Analysis was by intention to treat . From May 2006 to July 2008 , 1336 patients were followed . 444 ( 33 % ) of these patients were already on ART at the start of the study . No significant differences were found in lack of adherence ( < 95 % pill count adherence risk ratio [ RR ] 0.55 , 95 % confidence interval [ CI ] 0.23–1.35 ; < 100 % adherence RR 1.10 , 95 % CI 0.94–1.30 ) , cumulative risk of virologic failure ( RR 0.81 , 95 % CI 0.61–1.08 ) or in shorter-term virologic outcomes ( 24 week virologic failure RR 0.93 , 95 % CI 0.65–1.32 ; 48 week , RR 0.83 , 95 % CI 0.47–1.48 ; 72 week , RR 0.81 , 95 % CI 0.44–1.49 ) . However , virologic failure rates ≥96 weeks into ART were significantly decreased in the intervention arm compared to the control arm ( 96 week failure RR 0.50 , 95 % CI 0.31–0.81 ; 120 week , RR 0.59 , 95 % CI 0.22–1.60 ; 144 week , RR 0.39 , 95 % CI 0.16–0.95 ; 168 week , RR 0.30 , 95 % CI 0.097–0.92 ; 192 week , RR 0.067 , 95 % CI 0.0065–0.71 ) . Conclusions / Significance A PHW intervention was associated with decreased virologic failure rates occurring 96 weeks and longer into ART , but did not affect cumulative risk of virologic failure , adherence measures , or shorter-term virologic outcomes . PHWs may be an effective intervention to sustain long-term ART in low-re source setting s. Trial Registration Clinical Trials.gov Background As highly active antiretroviral therapy ( HAART ) becomes increasingly available to African children , it is important to evaluate simple and feasible methods of improving adherence in order to maximize benefits of therapy . Methods HIV-1-infected children initiating World Health Organization non-nucleoside reverse transcriptase-inhibitor-containing first-line HAART regimens were r and omized to use medication diaries plus counselling , or counselling only ( the control arm of the study ) . The diaries were completed daily by caregivers of children r and omized to the diary and counselling arm for nine months . HIV-1 RNA , CD4 + T cell count , and z-scores for weight-for-age , height-for-age and weight-for-height were measured at a baseline and every three to six months . Self-reported adherence was assessed by question naires for nine months . Results Ninety HIV-1-infected children initiated HAART , and were followed for a median of 15 months ( interquartile range : 2–21 ) . Mean CD4 percentage was 17.2 % in the diary arm versus 16.3 % in the control arm at six months ( p = 0.92 ) , and 17.6 % versus 18.9 % at 15 months ( p = 0.36 ) . Virologic response with HIV-1 RNA of < 100 copies/ml at nine months was similar between the two arms ( 50 % for the diary arm and 36 % for the control , p = 0.83 ) . The weight-for-age , height-for-age and weight-for-height at three , nine and 15 months after HAART initiation were similar between arms . A trend towards lower self-reported adherence was observed in the diary versus the control arm ( 85 % versus 92 % , p = 0.08 ) . Conclusion Medication diaries did not improve clinical and virologic response to HAART over a 15-month period . Children had good adherence and clinical response without additional interventions . This suggests that paediatric HAART with conventional counselling can be a successful approach . Further studies on targeted approaches for non-adherent children will be important OBJECTIVES To describe health-care use by persons with HIV in an urban area of Switzerl and ( Zurich ) . Further , to compare the different health-care setting s. DESIGN A 1-year prospect i ve cohort study recruiting 60 patients at general practice s and 60 patients at a specialized university outpatient clinic . METHODS Patients and their treating physicians were interviewed or answered question naires , respectively , at baseline , month 6 and 12 . RESULTS During the study period , five patient groups were identified among the 106 enrolled patients , of whom ( i ) 42 % saw a general practitioner exclusively , ( ii ) 31 % were treated at the specialized outpatient clinic , ( iii ) 8 % were in shared care , ( iv ) 10 % changed health-care model , and ( v ) 9 % were lost to follow-up . Baseline demographic , psychosocial and clinical data were similar among patient groups . At study end , the proportion of patients with HIV-1 RNA < 400 copies/mL was 72 % , 74 % , 88 % , 55 % among groups ( i ) to ( iv ) , respectively ( ns ) , and 22 % at month 6 among those lost to follow-up . Indicators for quality of care were similarly good among all patient groups . CONCLUSIONS A well-working system offers high- quality healthcare to persons living with HIV , where existing teams of specialty and primary health-care professionals efficiently and effectively co-operate Adherence to antiretroviral therapy ( ART ) represents one of the strongest predictors of progression to AIDS , yet it is difficult for most patients to sustain high levels of adherence . This study compares the efficacy of a personalized cell phone reminder system ( ARemind ) in enhancing adherence to ART versus a beeper . Twenty-three HIV-infected subjects on ART with self-reported adherence less than 85 % were r and omized to a cellular phone ( CP ) or beeper ( BP ) . CP subjects received personalized text messages daily ; in contrast , BP subjects received a reminder beep at the time of dosing . Interviews were scheduled at weeks 3 and 6 . Adherence to ART was measured by self-report ( SR , 7-day recall ) , pill count ( PC , past 30 days at baseline , then past 3 weeks ) , Medication Event Monitoring System ( MEMS ; cumulatively at 3 and 6 weeks ) , and via a composite adherence score constructed by combining MEMS , pill count , and self report . A mixed effects model adjusting for baseline adherence was used to compare adherence rates between the intervention groups at 3 and 6 weeks . Nineteen subjects completed all visits , 10 men and 9 females . The mean age was 42.7 ± 6.5 years , 37 % of subjects were Caucasian and 89 % acquired HIV heterosexually . The average adherence to ART was 79 % by SR and 65 % by PC at baseline in both arms ; over 6 weeks adherence increased and remained significantly higher in the ARemind group using multiple measures of adherence . A larger and longer prospect i ve study is needed to confirm these findings and to better underst and optimal reminder messages and user fatigue We evaluated a nurse-delivered adherence intervention in a preliminary r and omized controlled trial among 70 HIV-positive out patients initiating antiretroviral therapy ( ART ) in Beijing , China . In both arms , participants received a 30-min educational session , a pillbox , and a referral to a peer support group . In the enhanced arm , participants could choose an electronic reminder device , three sessions of counseling either alone or with a treatment adherence partner , or both reminder and counseling . Survey assessment s and blood draws occurred at baseline , post-intervention ( 13 weeks ) , and follow-up ( 25 weeks ) . Primary outcomes were 7-day and 30-day adherence assessed by self-report and electronic drug monitoring ( EDM ) , and secondary outcomes were HIV-1 RNA viral load and CD4 count . The intervention was feasible and well received . It led to some improvement in self-reported and EDM-assessed adherence but not the biological outcomes . Providing counseling and facilitating the use of electronic reminders to patients initiating ART merits further investigation as a culturally viable means of promoting adherence in China Background : There is a lack of effective behavioral interventions for HIV-positive injection drug users ( IDUs ) . We sought to evaluate the efficacy of an intervention to reduce sexual and injection transmission risk behaviors and to increase utilization of medical care and adherence to HIV medications among this population . Methods : HIV-positive IDUs ( n = 966 ) recruited in 4 US cities were r and omly assigned to a 10-session peer mentoring intervention or to an 8-session video discussion intervention ( control condition ) . Participants completed audio computer-assisted self-interviews and had their blood drawn to measure CD4 cell count and viral load at baseline and at 3-month ( no blood ) , 6-month , and 12-month follow-ups . Results : Overall retention rates for r and omized participants were 87 % , 83 % , and 85 % at 3 , 6 , and 12 months , respectively . Participants in both conditions reported significant reductions from baseline in injection and sexual transmission risk behaviors , but there were no significant differences between conditions . Participants in both conditions reported no change in medical care and adherence , and there were no significant differences between conditions . Conclusions : Both interventions led to decreases in risk behaviors but no changes in medical outcomes . The characteristics of the trial that may have contributed to these results are examined , and directions for future research are identified The principal objective of these multisite studies ( Florida , New York , New Jersey : epicenters for human immunodeficiency virus [ HIV ] among women ) was to develop and implement effective combinations of behavioral interventions to optimize the health status of the most neglected and understudied population affected by the acquired immunodeficiency syndrome ( AIDS ) epidemic in the United States : poor women of color living with HIV . The \n Output:\n " }, { "from": "agent", "value": "Although there is strong evidence that all five of these interventions can significantly increase ART adherence in some setting s , each intervention has also been found not to produce significant effects in several studies .\nCombination interventions tended to have effects that were similar to those of single interventions .\nThe evidence base on interventions in key population s was weak , with the exception of interventions for people who inject drugs ." } ]

[ { "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: Eighteen months after the 1980 initiation of the Canadian National Breast Screening Study ( NBSS ) ( a multicenter r and omized controlled trial that will involve 90,000 women ) , the Toronto center experience such severe problems with recruitment that the study as a whole was jeopardized . Impediments to recruitment arose in five areas . The design of the protocol was criticized by some physicians and participants , a problem that could only be met by justifying the design . A second problem was a lack of underst and ing of the concept of screening and mistaken assumptions about what participation in the NBSS entailed . Thirdly , recruitment problems occurred at a time when the media were focusing much attention on the hazards of low-level ionizing radiation . Fourthly , women were found to have a variety of personal reasons for delaying or avoiding entry into the study . Finally , factors characteristic of the Canadian milieu such as universal health coverage may have acted as a disincentive to entry . To improve physician underst and ing , NBSS personnel made presentations at medical rounds and scientific meetings ; articles were written for medical journals . To win support from the lay public , talks were given to recreation or work-based groups . Appearances on radio and television talk shows were sought out . Mass mailings to university staff and professional associations did not produce large responses , nor did advertisements on television , radio , or in newspapers . The distribution of a check insert in a government mailing gave rise to hundreds of appointments across Canada . However , for generating an ongoing adequate level of recruitment , the best measure has been the mailing of personally addressed letters to eligible women followed by a telephone call . Data on response rates , cost and women 's attitudes toward the study are reported . By early 1983 , Toronto met its recruitment target of 12,000 Identifying strategies for successful recruitment of ethnic minorities into scientific studies is critical . Without effective methods , investigators may fail to recruit the desired sample size , take longer to recruit than planned , and delay progress for research in minority health . Direct mail is an appealing recruitment method because of the potential for reaching large target population s and producing a high volume of inquiries about a study with relatively little staff effort . To determine which of three direct mail strategies yielded higher recruitment , 561 Hispanic employees were r and omly assigned to receive either : ( a ) a flyer about a worksite dietary intervention ; ( b ) the same flyer plus a personalized h and -signed letter containing heart disease risk statistics for the general American population ; or ( c ) the flyer plus a personalized h and -signed letter containing statistics for Hispanics . Two orthogonal chi-square comparisons were examined . The personalized letters plus flyer yielded a significantly higher response rate ( 7.8 % ) than the flyer alone ( 2.1 % ) , X2(1 , N=561)=7.5 , p=.006 . However , the personalized letter with Hispanic heart disease risk statistics did not yield a statistically significant higher response rate ( 9.1 % ) than the letter with the general population risk statistics ( 6.5 % ) , X2(1 , N=370)=0.9 , p>.34 . These findings suggest that personalized approaches can increase the effectiveness of direct mail efforts for recruiting ethnic minorities into interventions and may be particularly helpful for large-scale interventions BACKGROUND Latinas have low rates of participation in breast cancer prevention trials . We evaluated the feasibility and effectiveness of a r and omized trial of brief counseling and print material s compared to print material s alone to increase intent to participate in a breast cancer prevention trial . METHODS We enrolled 450 women Spanish-speaking women from three urban community primary care clinics . The outcome was intent , defined as might , probably , or definitely would enroll in the trial . We also examined results using a more stringent definition restricted to probably and definitely intend to participate . RESULTS The trial was feasible within these busy clinics , and 96 % of women agreed to participate . The level of breast cancer knowledge was fairly high ( 66 % correct answers ) , but underst and ing about clinical trials was lower ( 40.5 % correct answers ) . Using the less stringent criteria for intent , 72 % of women stated that they intended to enroll in the STAR trial if eligible , but rates of intent decreased to 52 % with framing that included medication side effects and 45 % if uterine cancer was mentioned ( P < 0.01 for trend ) . Using the more stringent definition , slightly fewer than half of the women indicated an interest in participating , with the same trend towards decreasing intent with increasing presentation of side effects . The intervention was only effective using the less stringent definition and if no side effects were mentioned ( 77 % intent vs. 67 % in the intervention and control groups , respectively , P = 0.03 ) . Intention was independently associated with greater worry about breast cancer and younger age , but not acculturation or knowledge . CONCLUSIONS Latina women are interested in participating in clinical trials to prevent breast cancer , although interest declines with increasing discussion of side effects . Unfortunately , brief education only increased rates of intention using the least stringent definition and when no side effects were presented in framing the question . Future work should focus on qualitative research to underst and the theoretical foundations of preventive health behaviors in this population PURPOSE Studies have documented that the majority of consent documents for medical diagnosis and treatment are written at a reading level above that of the majority of the U.S. population . This study hypothesized that use of an easy-to-read consent statement , when compared with a st and ard consent statement , will result in higher patient comprehension of the clinical treatment protocol , lower patient anxiety , higher patient satisfaction , and higher patient accrual . METHODS A r and omized controlled trial was conducted in 44 institutions that were members or affiliates of three cooperative oncology groups . Institutions were r and omly assigned to administer either an easy-to-read consent statement or the st and ard consent statement to patients being recruited to participate in selected cancer treatment trials . Telephone interviews were conducted with a total of 207 patients to assess study outcomes . RESULTS Patients in the intervention arm demonstrated significantly lower consent anxiety and higher satisfaction compared with patients in the control arm . Patient comprehension and state anxiety were not affected by the intervention . Accrual rates into the parent studies also did not differ significantly between the two study groups . CONCLUSION Clinical trial informed consent statements can be modified to be easier to read without omitting critical information . Patient anxiety and satisfaction can be affected by the consent document . The generalizability of these study results is limited by the characteristics of the patient sample . Ninety percent of the sample were white women , and the mean Rapid Estimate of Adult Literacy in Medicine score was approximately 64 , indicating a literacy level at or above the ninth grade Recruitment to cancer clinical trials needs to be improved , as does patient knowledge and underst and ing about clinical trials , in order for patients to make an informed choice about whether or not to take part . Audiovisual patient information ( AVPI ) has been shown to improve knowledge and underst and ing in various areas of practice , but there is limited information about its effect in the cancer clinical trial setting , particularly in relation to consent rates . In this study , 173 patients were r and omised to receive either the AVPI , in addition to the st and ard trial-specific written information , or the written information alone . There was no difference in clinical trial recruitment rates between the two groups with similar study entry rates : 72.1 % in the AVPI group and 75.9 % in the st and ard information group . The estimated odds ratio for refusal ( intervention/no intervention ) was 1.19 ( 95 % CI 0.55–2.58 , P=0.661 ) . Knowledge scores increased more in the AVPI group compared to the st and ard group ( P=0.0072 ) . The change in anxiety score between the arms was also statistically significant ( P=0.011 ) with anxiety improving in the intervention arm more than in the no intervention arm . Audiovisual patient information was shown to be a useful tool in improving patient knowledge and anxiety , but further work is necessary in relation to its effect on clinical trial recruitment rates A common question in clinical consultations is : “ For this person , what are the likely effects of one treatment compared with another ? ” The central tenet of evidence based medicine is that this task is achieved by using the best evidence combined with consideration of that person 's individual needs.1 A further question then arises : “ What is the best evidence ? ” Two recent studies in the New Engl and Journal of Medicine have caused uproar in the research community by finding no difference in estimates of treatment effects between r and omised controlled trials and non-r and omised trials . The r and omised controlled trial and , especially , systematic review s of several of these trials are traditionally the gold st and ards for judging the benefits of treatments , mainly because it is conceptually easier to attribute any observed effect to the treatments being compared . The role of non-r and omised ( observational ) studies in evaluating treatments is contentious : deliberate choice of the treatment for each person implies that observed outcomes may be caused by differences among people being given the two treatments , rather than the treatments alone . Unrecognised confounding factors can always interfere with attempts to correct for identified differences between groups . These considerations have supported a hierarchy of evidence , with r and omised controlled trials and derivatives at the top , controlled Background and Purpose — Methods to increase recruitment into acute stroke trials are needed . The purpose s of this study were to evaluate the safety and acceptability of initiating acute stroke trials during early helicopter evacuation and to test an intervention to facilitate informed consent . Methods — A r and omized , controlled trial was done with patients with acute stroke who were transferred by helicopter to the University of Iowa Hospitals and Clinics from February 2007 to January 2008 . The intervention to be evaluated was the use of fax and a telephone call to the patient/surrogate ahead of helicopter arrival at the outside emergency department . The aim was to improve the rate of subsequent consent ( primary outcome ) for a pilot trial of a potentially beneficial , low-risk medical intervention ( ranitidine ) to prevent aspiration pneumonitis . Consenting eligible patients received the infusion during the flight to University of Iowa Hospitals and Clinics . Results — One hundred patients were enrolled . Consent rate was 54 % in the intervention group and 50 % in the control group ( P=0.69 ) . However , the consent rate was higher ( 69 % ) when prearrival communications between the coinvestigator and potential subjects were successful ( P=0.04 ) . This approach result ed in an average gain of 59 minutes as compared with initiating recruitment on arrival to University of Iowa Hospitals and Clinics . Conclusions — Enrollment into stroke intervention trials is feasible during helicopter transportation from a community hospital emergency department to a tertiary stroke center . This underused re source may improve trial efficiency by enabling and expediting participation of remote population s currently excluded from research . Consent rates might be further improved by communication strategies that are more successful in reaching patients at outside emergency departments BACKGROUND To evaluate the impact of an educational booklet on women 's knowledge of and willingness to participate in a r and omized clinical trial of treatment for breast cancer . MATERIAL S AND METHODS Women undergoing surgery for newly diagnosed early stage breast cancer were r and omized to receive , or not , an information booklet explaining the need for and manner in which r and omized trials are conducted . RESULTS Eighty-three women with newly diagnosed early stage breast cancer completed a question naire assessing attitudes to r and om clinical trials ( RCTs ) and were r and omized to receive usual information treatment options provided from their oncologist , or the educational booklet in addition to usual information from their oncologist ( 42 usual information , 41 booklet ) . Fewer women who received the clinical trials booklet ( 40 % versus 47 % ) would consider participating in the hypothetical clinical trial ( P = 0.6 ) . Mean knowledge scores increased for both groups ; moreover , women who did not receive the booklet showed similar improvements to women who received the booklet [ mean difference 0.09 , 95 % confidence interval ( CI ) -0.66 to 0.83 ] . In a multivariate analysis women who would consider participating in the clinical trial were more anxious [ odds ratio ( OR ) 5.9 , P = 0.02 ] had involved lymph nodes ( OR 5.8 , P = 0.02 ) and were less influenced by negative aspects of clinical trials ( OR 7.7 , P = 0.0001 ) . After adjustment for these variables women who received the educational booklet were significantly less likely to consider trial participation ( OR 0.22 , P = 0.05 ) . CONCLUSIONS Educating women about clinical trials in this manner appears ineffective in improving recruitment to RCTs . Women appear to be more influenced by their perception of risk than underst and ing . This finding has ethical implication s for communication of information about RCTs Recruitment into public health intervention trials can be costly and time-consuming . We examined two components of recruitment for an exercise trial : ( a ) a r and omized pilot study of mailing strategies ; and ( b ) the results from the entire recruitment process . In the pilot study , 4,999 women were r and omized into one of four groups using a factorial design . The first factor was the inclusion or exclusion of a personal invitation letter , and the second was the use of first-class stamps versus bulk mail . We received 580 ( 11.6 % ) responses . Responses from interested women were nonsignificantly higher ( odds ratio , 1.19 ; P = 0.10 ) for first-class versus bulk-rate postage . However , the cost to r and omize one participant using first-class mail was $ 56.14 ( in 1998 dollars ) more than for bulk mail . We found no difference in response when including the invitation letter ( odds ratio , 1.00 ; P > 0.50 ) . The general recruitment process identified potentially eligible women primarily through mass mailings but also through media and other sources . We mailed recruitment material s , via bulk mail and including an invitation letter , to 103,577 women in the Seattle area over 2 years . Response rates were different ( P < 0. \n Output:\n " }, { "from": "agent", "value": "Patrina Caldwell and colleagues performed a systematic review of r and omized studies that compared methods of recruiting individual study participants into trials , and found that strategies that focus on increasing potential participants ' awareness of the specific health problem , and that engaged them , appeared to increase recruitment" } ]

[ { "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 Diabetes mellitus is a strong risk factor for cardiovascular and renal disease . We investigated whether the angiotensin-converting-enzyme ( ACE ) inhibitor ramipril can lower these risks in patients with diabetes . METHODS 3577 people with diabetes included in the Heart Outcomes Prevention Evaluation study , aged 55 years or older , who had a previous cardiovascular event or at least one other cardiovascular risk factor , no clinical proteinuria , heart failure , or low ejection fraction , and who were not taking ACE inhibitors , were r and omly assigned ramipril ( 10 mg/day ) or placebo , and vitamin E or placebo , according to a two-by-two factorial design . The combined primary outcome was myocardial infa rct ion , stroke , or cardiovascular death . Overt nephropathy was a main outcome in a sub study . FINDINGS The study was stopped 6 months early ( after 4.5 years ) by the independent data safety and monitoring board because of a consistent benefit of ramipril compared with placebo . Ramipril lowered the risk of the combined primary outcome by 25 % ( 95 % CI 12 - 36 , p=0.0004 ) , myocardial infa rct ion by 22 % ( 6 - 36 ) , stroke by 33 % ( 10 - 50 ) , cardiovascular death by 37 % ( 21 - 51 ) , total mortality by 24 % ( 8 - 37 ) , revascularisation by 17 % ( 2 - 30 ) , and overt nephropathy by 24 % ( 3 - 40 , p=0.027 ) . After adjustment for the changes in systolic ( 2.4 mm Hg ) and diastolic ( 1.0 mm Hg ) blood pressures , ramipril still lowered the risk of the combined primary outcome by 25 % ( 12 - 36 , p=0.0004 ) . INTERPRETATION Ramipril was beneficial for cardiovascular events and overt nephropathy in people with diabetes . The cardiovascular benefit was greater than that attributable to the decrease in blood pressure . This treatment represents a vasculoprotective and renoprotective effect for people with diabetes The primary results of a three-year prospect i ve , double-blind , placebo-controlled trial in non-insulin-dependent diabetic ( NIDDM ) patients show that an anti-hypertensive regimen , which includes the ACE inhibitor enalapril , preserves renal function to a greater extent than therapy with antihypertensive agents excluding ACE inhibitors ( J Am Soc Nephrol 3:335 , 1992 ) . The influence of baseline urinary albumin excretion on the renal protective effects of enalapril treatment in these subjects was the objective of this further analysis . Adequate data were available in 121 patients of the 165 hypertensive NIDDM individuals studied [ baseline glomerular filtration rate ( GFR ) 30 to 100 ml/min/1.73 m2 ] . Twenty-four hour urinary excretion of albumin ( UAE ) , protein , urea nitrogen , creatinine and isotopically determined GFR were measured at baseline and six month intervals . Glycemic control and blood pressure regulation were assessed every three months . The rate of loss of GFR was significantly greater in patients with overt proteinuria at baseline ( UAE > 300 mg/24 hr ) as compared to patients with baseline sub- clinical proteinuria ( UAE < or = 300 mg/24 hr ) . Antihypertensive treatment with enalapril preserved GFR significantly better ( P < 0.01 ) in the patients with sub- clinical proteinuria at baseline ( UAE < or = 300 mg/24 hr ) than other antihypertensive treatments which excluded the ACE inhibitor . Furthermore , only 7 % of the enalapril-treated group progressed to clinical albuminuria compared to 21 % of control treated patients . Although the enalapril-treated group had a lower mean blood pressure during the maintenance period , no correlation between blood pressure ( systolic , diastolic or mean arterial ) and rate of change of GFR was observed . ( ABSTRACT TRUNCATED AT 250 WORDS OBJECTIVE Determine the prevalence of microalbuminuria in patients with type 2 diabetes mellitus ( DM ) in general practice , as an independent risk factor for cardiovascular diseases . DESIGN Prospect i ve , descriptive . METHOD Data were collected on patients with type 2 DM in the Zwolle region of the Netherl and s , all of whom were being treated by their general practitioner . The inclusion period was 1 February 2000 - 31 January 2001 . The study formed part of a larger investigation , in which the albumin concentration in a urine sample and the albumin-creatinin ratio were determined once per year . A total of 32 general practitioners took part in the study . RESULTS In the general practice s studied , 2094 patients were known with type 2 DM and 1653 ( 79 % ) were treated exclusively by the general practitioner . Of these 1653 patients , 67 ( 4 % ) were excluded and of the 1586 invited patients remaining , 1441 ( 91 % ) participated . Microalbuminuria was present in 33 % of the patients and macroalbuminuria in 7 % of the patients , and the prevalences increased with age : < 50 , 50 - 70 and > 70 years . 18 % ( 6/33 ) of the patients aged < 50 years with microalbuminuria were treated with an ACE inhibitor or angiotensin II antagonist compared to 33 % ( 183/548 ) of patients > or = 50 years . 91 % ( 488/539 ) of the patients > or = 50 years with microalbuminuria had hypertension and /or lipid profile abnormalities and 82 % ( 402/488 ) of them were not treated or did not receive adequate treatment for this condition . CONCLUSION Microalbuminuria and macroalbuminuria were present in respectively 33 % and 7 % of the patients with type 2 DM in primary care . The treatment of hypertension and lipid profile abnormalities was often inadequate . Therefore , screening patients aged 50 years and older with type 2 DM for albuminuria is justified Background —The aim of this study was to assess the level of urinary albumin excretion ( microalbuminuria ) , which is associated with increased risk of coronary heart disease and death , in the population . Microalbuminuria has been suggested as an atherosclerotic risk factor . However , the lower cutoff level of urinary albumin excretion is unknown . It is also unknown whether impaired renal function confounds the association . Methods and Results —In the Third Copenhagen City Heart Study in 1992 to 1994 , 2762 men and women 30 to 70 years of age underwent a detailed cardiovascular investigation program , including a timed overnight urine sample . The participants were then followed up prospect ively by registers until 1999 with respect to coronary heart disease and until 2001 with respect to death . During follow-up , 109 incident cases of coronary heart disease and 276 deaths were traced . A urinary albumin excretion above the upper quartile , ie , 4.8 μg/min , was associated with increased risk of coronary heart disease ( RR , 2.0 ; 95 % CI , 1.4 to 3.0 ; P < 0.001 ) and death ( RR , 1.9 ; 95 % CI , 1.5 to 2.4 ; P < 0.001 ) independently of age , sex , renal creatinine clearance , diabetes mellitus , hypertension , and plasma lipids . Lower levels of urinary albumin excretion were not associated with increased risk . Conclusions —Microalbuminuria , defined as urinary albumin excretion > 4.8 μg/min ( corresponding to ≈6.4 μg/min during daytime ) , is a strong and independent determinant of coronary heart disease and death . Our suggestion is to redefine microalbuminuria accordingly and perform intervention studies Objective The aim of this open-labelled , r and omised , parallel-group study was to evaluate the effect of long-term monotherapy with manidipine or lisinopril on albumin excretion rate ( AER ) and left ventricular mass index ( LVMI ) in hypertensive patients with type-2 diabetes and microalbuminuria . Methods After a 4-week wash-out period , 174 patients with essential hypertension [ diastolic blood pressure ( DBP ) > 80 mmHg and < 100 mmHg ] , type-2 diabetes and microalbuminuria were r and omised to manidipine 10 mg o.d . or lisinopril 10 mg o.d . ; after 8 weeks , the dose was doubled in non-responders ( DBP > 80 mmHg ) ; after 3 months , treatment was discontinued in the non-responder patients and in those complaining of side effects ; the remaining 121 patients continued their therapy with manidipine or lisinopril , and 99 completed the 2-year study . At the end of the wash-out period , of the titration period and after 6 , 12 , 18 and 24 months of treatment , BP was measured , AER , creatinine clearance , glycosylated haemoglobin ( HbA1c ) and body mass index ( BMI ) were evaluated and an echocardiographic evaluation was performed . Results The 99 patients who completed the study were statistically analysed according to a per- protocol evaluation . Manidipine and lisinopril significantly reduced systolic blood pressure ( SBP ) and DBP levels ( at 24 months , −22.3/15.5 mmHg , P<0.001 versus baseline and −21.4/15.7 mmHg , P<0.01 versus baseline , respectively ) . Both drugs provided a significant decrease in AER , but it was significantly more pronounced with lisinopril ( at 24 weeks , −37.2 mg/24 h , P<0.001 versus baseline ) than with manidipine ( –29.9 mg/24 h , P<0.05 versus baseline ) and became evident earlier in the lisinopril group ( after 3 months versus 6 months of treatment ) . Manidipine produced a greater reduction of LVMI than lisinopril ( −14.9 g/m2 versus –10.8 g/m2 at 24 months ) . The effect was more pronounced in patients with left ventricular hypertrophy at baseline ( −19.8 g/m2 versus –12.8 g/m2 , P<0.05 ) . Conclusion These data suggest that , despite similar BP lowering , non-haemodynamic factors play an important role in the pharmacological reduction of AER and LVMI in diabetic hypertensive patients The aim of this study was to compare the effects of ramipril and nitrendipine chronic treatment on urinary albumin excretion ( UAE ) in hypertensive patients with type II non-insulin-dependent diabetes mellitus ( NIDDM ) and impaired renal function . A 2-year , prospect i ve , r and omised study was conducted on 51 men with a diastolic blood pressure ( DBP ) ⩾95 and ⩽105 mm Hg , stable NIDDM , serum creatinine between 1.6 and 3.0 mg/dl and persistent UAE > 300 and < 2000 mg/24 h. after a 3-month preliminary observation period , during which patients began a low-protein , low-sodium diet , and a subsequent 4-week run-in period on placebo , patients were r and omly treated with ramipril 5 mg or nitrendipine 20 mg for 2 years . both drugs similarly reduced bp without affecting glucose homeostasis . in the ramipril group uae significantly decreased after only 3 months of treatment , whereas in the nitrendipine group a significant although lesser reduction in uae was observed only after 1 year . during the second year the uae% change was not statistically different between the two treatments . serum creatinine and creatinine clearance showed no significant change with both drugs . the progression of renal insufficiency as assessed by the rate of reduction of creatinine clearance over the 2 years of the study was similar in the ramipril and the nitrendipine groups . in conclusion both ramipril and nitrendipine were associated with a decrease in uae although such a reduction was earlier and more marked with ramipril . the decline of renal function did not differ significantly between the two treatments Mixed treatment comparison ( MTC ) meta- analysis is a generalization of st and ard pairwise meta- analysis for A vs B trials , to data structures that include , for example , A vs B , B vs C , and A vs C trials . There are two roles for MTC : one is to strengthen inference concerning the relative efficacy of two treatments , by including both ' direct ' and ' indirect ' comparisons . The other is to facilitate simultaneous inference regarding all treatments , in order for example to select the best treatment . In this paper , we present a range of Bayesian hierarchical models using the Markov chain Monte Carlo software WinBUGS . These are multivariate r and om effects models that allow for variation in true treatment effects across trials . We consider models where the between-trials variance is homogeneous across treatment comparisons as well as heterogeneous variance models . We also compare models with fixed ( unconstrained ) baseline study effects with models with r and om baselines drawn from a common distribution . These models \n Output:\n " }, { "from": "agent", "value": "The ACEI/ARB benefit over placebo was significant for all outcomes except microalbuminuria .\nA network meta- analysis detected significant treatment effects across all outcomes for both active drugs and placebo comparisons .\nConclusions /interpretationOur review suggests a consistent reno-protective effect of ACEI/ARB over other antihypertensive drugs , mainly CCBs , and placebo in type 2 diabetes .\nThe lack of any differences in BP decrease between ACEI/ARB and active comparators suggest this benefit is not due simply to the antihypertensive effect" } ]

[ { "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 Because universal psychoeducational eating disorder prevention programs have had little success , we developed and evaluated two interventions for high-risk population s : a healthy weight control intervention and a dissonance-based intervention . METHOD Adolescent girls ( N = 148 ) with body image concerns were r and omized to one of these interventions or to a waitlist control group . Participants completed baseline , termination , and 1 , 3 , and 6-month follow-up surveys . RESULTS Participants in both interventions reported decreased thin-ideal internalization , negative affect , and bulimic symptoms at termination and follow-up relative to controls . However , no effects were observed for body dissatisfaction or dieting and effects diminished over time . DISCUSSION Results provide evidence that both interventions effectively reduce bulimic pathology and risk factors for eating disturbances A population -based , r and omized universal classroom intervention trial for the prevention of disruptive behavior ( i.e. , attention-deficit/hyperactivity problems , oppositional defiant problems , and conduct problems ) is described . Impact on developmental trajectories in young elementary schoolchildren was studied . Three trajectories were identified in children with high , intermediate , or low levels of problems on all 3 disruptive behaviors at baseline . The intervention had a positive impact on the development of all disruptive behavior problems in children with intermediate levels of these problems at baseline . Effect sizes of mean difference at outcome were medium or small . In children with the highest levels of disruptive behavior at baseline , a positive impact of the intervention was found for conduct problems BACKGROUND The high prevalence and incidence of obesity and eating disorders in US adolescent girls are serious health problems . Because of the shared risk factors for obesity and eating disorders , a targeted prevention of both conditions is a priority . OBJECTIVE We determined whether an adapted interpersonal psychotherapy prevention program is more efficacious for reducing excess weight gain and worsening disordered eating than health education in adolescent girls at high risk of obesity and eating disorders . DESIGN A parallel-group , r and omized controlled trial was conducted between September 2008 and January 2013 in a university-based laboratory and a federal research hospital . The study included 113 adolescent ( 12 - 17-y-old ) girls deemed at high risk of adult obesity and eating disorders because of a body mass index ( BMI ) between the 75th and 97th percentiles and reports of episodes of a loss of control over their eating . Girls were r and omly assigned to participate in an adapted interpersonal psychotherapy or a health-education group program for 12 weekly 90-min group sessions . Follow-up assessment s occurred immediately after group programs and at 6 and 12 mo . RESULTS Participation in both conditions was associated with decreases in expected BMI gain , age-adjusted BMI metrics , the percentage of fat by using dual-energy X-ray absorptiometry , symptoms of depression and anxiety , and the frequency of loss-of-control eating over 12 mo of follow-up ( Ps < 0.001 ) with no group difference . In follow-up analyses , interpersonal psychotherapy was more efficacious than health education at reducing objective binge eating at the 12-mo follow-up ( P < 0.05 ) . CONCLUSIONS The intervention with adolescent girls with loss-of-control eating is associated with lower age-adjusted BMI and percentage of adiposity as well as improved mood symptoms over 1 y. Interpersonal psychotherapy further reduced objective binge eating . Additional research is needed to eluci date the mechanisms by which physical and psychological improvements were observed . This trial was registered at clinical trials.gov as NCT00680979 OBJECTIVE Body dissatisfaction in females is common and a risk factor for the development of an eating disorder . This study tested whether body dissatisfaction could be improved using a brief conditioning intervention in which photographs of participants ' bodies were selectively paired with positive social stimuli ( smiling faces ) and photographs of other bodies were paired with neutral or negative social stimuli ( neutral and frowning faces ) . METHOD 39 women ( mean age = 22.46 ; 64.1 % Caucasian ) with high body dissatisfaction were r and omized to either the evaluative conditioning intervention ( n = 22 ) or to a delayed waitlist control condition ( n = 17 ) . Body dissatisfaction ( specifically , shape and weight concern ) , restraint , eating concern , and self-esteem were assessed at baseline , post treatment and again after four and 12 weeks . RESULTS Compared to women in the delayed waitlist control condition , women in the treatment condition demonstrated a significant decrease in shape and weight concern , and a significant increase in self-esteem . Similar trends were found for the control condition after they completed the intervention . Changes at post treatment related to body dissatisfaction were maintained at 12-week follow-up . CONCLUSIONS Repeatedly pairing photographs of an individual 's body with positive social feedback may lead to improved body image and self-esteem OBJECTIVE A group dissonance-based eating disorder prevention program , in which young women critique the thin ideal , reduces eating disorder risk factors and symptoms , but it can be difficult to identify school clinicians with the time and expertise to deliver the intervention . Thus , we developed a prototype Internet version of this program and evaluated it in a preliminary trial . METHOD Female college students with body dissatisfaction ( N = 107 ; M age = 21.6 years , SD = 6.6 ) were r and omized to the Internet intervention , group intervention , educational video condition , or educational brochure condition . RESULTS Internet and group participants showed greater pre-post reductions in eating disorder risk factors and symptoms than video controls ( M ds = 0.47 and 0.54 , respectively ) and brochure controls ( M ds = 0.75 and 0.72 , respectively ) , with many effects reaching significance . Effects did not differ significantly for Internet versus group participants ( M ds = -0.13 ) or for video versus brochure controls ( M d = 0.25 ) . Effect sizes for the Internet intervention were similar to those previously observed for group versions of this intervention . CONCLUSIONS Results suggest that this prototype Internet intervention is as efficacious as the group intervention , implying that there would be merit in completing this intervention and evaluating it in a fully powered trial Oral healthcare providers have a clinical opportunity for early detection of disordered eating behaviors because they are often the first health professionals to observe overt oral and physical signs . Curricula regarding early recognition of this oral/systemic medical condition are limited in oral health educational programs . Web-based learning can supplement and reinforce traditional learning and has the potential to develop skills . The study purpose was to determine the efficacy of a theory-driven Web-based training program to increase the capacity of oral health students to perform behaviors related to the secondary prevention of disordered eating behaviors . Using the Reach , Effectiveness , Adoption , Implementation and Maintenance evaluation framework , a longitudinal group-r and omized controlled trial involving 27 oral health classes from 12 oral health education programs in the United States was implemented to assess the efficacy of the Web-based training on attitudes , knowledge , self-efficacy and skills related to the secondary prevention of disordered eating behaviors . Mixed-model analysis of covariance indicated substantial improvements among students in the intervention group ( effect sizes : 0.51 - 0.83 ) on all six outcomes of interest . Results suggest that the Web-based training program may increase the capacity of oral healthcare providers to deliver secondary prevention of disordered eating behaviors . Implication s and value of using the Reach , Effectiveness , Adoption , Implementation and Maintenance framework are discussed This study evaluated a targeted intervention design ed to alleviate body image and eating problems in adolescent girls that was delivered over the internet so as to increase access to the program . The program consisted of six , 90-minute weekly small group , synchronous on-line sessions and was facilitated by a therapist and manual . Participants were 73 girls ( mean age=14.4 years , SD=1.48 ) who self-identified as having body image or eating problems and were r and omly assigned to an intervention group ( n=36 ) ( assessed at baseline , post-intervention and at 2- and 6-months follow-up ) or a delayed treatment control group ( n=37 ) ( assessed at baseline and 6–7 weeks later ) . Clinical ly significant improvements in body dissatisfaction , disordered eating , and depression were observed at post-intervention and maintained at follow-up . Internet delivery was enthusiastically endorsed . The program offers a promising approach to improve body image and eating problems that also addresses geographic access problems Proper r and omisation means little if investigators can not include all r and omised participants in the primary analysis . Participants might ignore follow-up , leave town , or take aspartame when instructed to take aspirin . Exclusions before r and omisation do not bias the treatment comparison , but they can hurt generalisability . Eligibility criteria for a trial should be clear , specific , and applied before r and omisation . Readers should assess whether any of the criteria make the trial sample atypical or unrepresentative of the people in which they are interested . In principle , assessment of exclusions after r and omisation is simple : none are allowed . For the primary analysis , all participants enrolled should be included and analysed as part of the original group assigned ( an intent-to-treat analysis ) . In reality , however , losses frequently occur . Investigators should , therefore , commit adequate re sources to develop and implement procedures to maximise retention of participants . Moreover , research ers should provide clear , explicit information on the progress of all r and omised participants through the trial by use of , for instance , a trial profile . Investigators can also do secondary analyses on , for instance , per- protocol or as-treated participants . Such analyses should be described as secondary and non-r and omised comparisons . Mish and ling of exclusions causes serious method ological difficulties . Unfortunately , some explanations for mish and ling exclusions intuitively appeal to readers , disguising the seriousness of the issues . Creative mismanagement of exclusions can undermine trial validity BACKGROUND Body image dissatisfaction during adolescence is common but not benign . School-based interventions have the potential for wide reach , but scalability of previous programmes is limited by a reliance on external facilitators . AIMS To assess the acceptability , feasibility and efficacy of a teacher-delivered body image intervention . METHOD A pilot clustered r and omised controlled trial in which 16 classes of adolescent girls were allocated to a 6-session body image programme ( n = 261 ) , or usual curriculum control ( n = 187 ) ( registration : IS RCT N42594993 ) . RESULTS Students in the intervention group had significantly improved body esteem and self-esteem and reduced thin-ideal internalisation . Effects for body esteem and thin-ideal internalisation were maintained for 3 months . There were no group differences for eating pathology , peer factors or depression . Acceptability , feasibility and efficacy varied between schools . CONCLUSIONS Teacher-delivered body image lessons have promise but further work is needed to increase efficacy and make interventions suitable across a range of schools OBJECTIVE Lifestyle interventions that promote physical activity and healthy dietary habits may reduce binge eating symptoms and be more feasible and sustainable among ethnic minority women , who are less likely to seek clinical treatment for eating disorders . The purpose of this study was to investigate ( 1 ) whether participating in a lifestyle intervention is a feasible way to decrease binge eating symptoms ( BES ) and ( 2 ) whether changes in BES differed by intervention ( physical activity vs. dietary habits ) and binge eating status at baseline ( binger eater vs. non-binge eater ) in African American and Hispanic women . METHOD Health Is Power ( HIP ) was a longitudinal r and omized controlled trial to promote physical activity and improve dietary habits . Women ( N = 180 ) who completed anthropometric measures and question naires assessing fruit and vegetable and dietary fat intake , BES and demographics at baseline and post-intervention six months later were included in the current study . RESULTS Over one-fourth ( 27.8 % ) of participants were categorized as binge-eaters . Repeated measures ANOVA demonstrated significant two- and three-way interactions . Decreases in BES over time were greater in binge eaters than in non-binge eaters ( F(1,164 ) = 33.253 , p < .001 ) , and women classified as binge eaters who participated in the physical activity intervention reported greater decreases in BES than non-binge eaters in the dietary habits intervention ( F(1,157 ) = 5.170 , p = .024 ) . DISCUSSION Findings suggest behavioral interventions to increase physical activity may lead to reductions in BES among ethnic minority women and ultimately reduce the prevalence of binge eating disorder and health disparities in this population OBJECTIVE This study examined the outcome of a body image and disordered eating intervention for midlife women . The intervention was specifically design ed to address risk factors that are pertinent in midlife . METHOD Participants were 61 women aged 30 to 60 years ( M = 43.92 , SD = 8.22 ) r and omly assigned to intervention ( n = 32 ) or ( delayed treatment ) control ( n = 29 ) groups . Following an 8-session facilitated group cognitive behavioral therapy-based intervention , outcomes from the Body Shape Question naire ; Eating Disorder Examination Question naire ; Body Image Avoidance Question naire ; Physical Appearance Comparison Scale ; Sociocultural Attitudes Towards Appearance Scale , Internalization subscale ; measures of appearance importance , cognitive re appraisal , and self-care ; Dutch Eating Behavior Question naire ; and Kessler Psychological Distress Scale were compared for statistical and clinical significance from baseline to posttest and 6-month follow-up . RES \n Output:\n " }, { "from": "agent", "value": "RESULTS Media literacy had the most support for universal prevention .\nMost universal approaches showed significant modest effects on risk factors .\nDissonance-based was the best supported approach for selective prevention .\nCognitive-behavior therapy ( CBT ) , a healthy weight program , media literacy , and psychoeducation , were also effective for selective prevention and effects were maintained at follow-up .\nCBT was supported for indicated prevention and effects were maintained at follow-up .\nDISCUSSION The modest effects for universal prevention were likely due to floor effects ." } ]

[ { "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 Several studies have shown that nonfixation of mesh in total extraperitoneal ( TEP ) inguinal hernia repair is safe and has no disadvantage compared to mesh fixation in terms of recurrence rate , pain scores , and other morbidity parameters . The aim of this study was to compare the effect of nonfixation of mesh with fixation in laparoscopic TEP inguinal hernia repair in a rural hospital in India . Methods One hundred four patients were r and omized to mesh nonfixation group or a fixation group during TEP . The postoperative pain scores on a visual analog scale ( VAS ) at 24 h , 1 week , 1 month , and 1 year , urinary retention , seroma formation , length of hospital stay , days taken to resume normal activities , and recurrence after 2 years were analyzed . The trial was registered at www . clinical trials.gov ( ID : NCT01117337 ) . Results One hundred four patients ( 194 hernias ) were r and omized to mesh nonfixation or fixation . The pain scores at 24 h were comparable ( Fix , 1.31 ± 0.4 ; Nonfix , 1.42 ± 0.5 , P = 0.23 ) . The length of hospital stay ( Fix , 1.12 ± 0.3 days ; Nonfix , 1.15 ± 0.4 days , P = 0.7 ) and days taken to resume normal activities ( Fix , 7.77 ± 1.3 days ; Nonfix , 7.96 ± 1.15 days , P = 0.44 ) were also similar for both groups . The mean pain scores at 1 week ( Fix , 1.25 ± 0.5 ; Nonfix , 1.34 ± 0.6 , P = 0.42 ) , 1 month ( Fix , 1.06 ± 0.2 ; Nonfix , 1.17 ± 0.4 , P = 0.12 ) , 1 year ( Fix , 1.04 ± 0.2 ; Nonfix , 1.13 ± 0.4 , P = 0.11 ) , and 2 years ( Fix , 1.03 ± 0.2 ; Nonfix , 1.0 , P = 0.17 ) were comparable for both groups . There was no recurrence in either group at a minimum follow-up of 2 years . Conclusions There was no significant difference between fixation and nonfixation of mesh in TEP inguinal hernia repair with respect to postoperative pain , length of hospital stay , resumption of normal activities , seroma formation , and recurrence rate . Nonfixation of mesh is safe and recommended in TEP inguinal hernia repair when done by an experienced surgeon , even in a rural setting . The study highlights the potential for universal application of the procedure Background The open tension-free mesh-plug hernia technique , transabdominal preperitoneal ( TAPP ) technique , and totally extraperitoneal ( TEP ) laparoscopic technique all are common surgical procedures for primary unilateral inguinal hernia repair . However , the choice of the right surgical procedure still is controversial in China . This study aim ed to compare open tension-free hernioplasty with two laparoscopic hernia repairs . Methods In this study , 164 male patients with primary unilateral inguinal hernia were r and omized to undergo an open operation with mesh-plug and patch , TAPP , or TEP . Results Completion of the study required 3 years , from February 2006 to February 2009 . Of the 164 patients , 62 underwent open repair , 50 had TAPP , and 52 had TEP . The patients then were followed up for 15.6 ± 8.5 months . The average operating time for the open repair group was significantly shorter than for the other two groups ( p < 0.001 ) . The cost for the open repair group also was significantly less than for the other two groups ( p < 0.001 ) . By contrast , the pain scores in the open mesh group were significantly higher than in the other two groups ( p < 0.001 ) . The hospital stay and the recovery time both were significantly longer in open repair group than in the other two groups ( p < 0.001 ) . No major complications or recurrence was found in any of the groups . Conclusions The findings show that open tension-free mesh-plug hernia repair , TAPP , and TEP are safe and effective for patients with primary unilateral inguinal hernia . Both TAPP and TEP are superior to open repair in terms of less postoperative pain and faster recovery time . The authors therefore recommend laparoscopic repair techniques as the preferable choice of surgical procedure . However , they think open repair will remain a practical solution in China because of its lower cost , short learning period , and need for no special equipment Background : The laparoscopic repair of inguinal hernias remains a controversial subject . Advantages in terms of reduced postoperative pain and improved functional status have been demonstrated in some studies and refuted in others . We performed a prospect i ve study of a group of young healthy patients to measure pain levels and time to return to normal activity following totally extraperitoneal laparoscopic ( TEP ) hernia repair and compared these outcomes to those seen following conventional anterior repair . Methods : A total of 151 patients were entered into a prospect i ve nonr and omized study . Forty-eight patients underwent anterior repair ; 103 underwent TEP repair . Patients were followed at 2 and 6 weeks to assess their level of function on a five-point scale . Their use of pain medication was also assessed , and total days away from work and days until return to full activity were documented . Results : The open group returned to work at 11.5 days and to full activity at 26.7 days . The TEP group returned to work at 6.4 days and to full activity at 14.2 days ( p < 0.001 for both data ) . There was no statistically significant difference in the use of pain medication . The TEP group reported better functional status at 2 weeks than the open group . At 6 weeks , this difference was no longer statistically significant . Conclusion : As compared to conventional open repair , TEP hernia repair offers advantages in postoperative function and an earlier return to full activity Background Data are insufficient to compare transabdominal preperitoneal repair ( TAPP ) and total extraperitoneal ( TEP ) techniques of laparoscopic inguinal hernia repair . There is very scant data comparing the two techniques in terms of long-term outcomes , which include chronic groin pain , quality of life , and time to return to normal activity . This prospect i ve , r and omized , controlled trial compared TEP versus TAPP techniques of laparoscopic inguinal hernia repair in terms of these long-term outcomes . Methods This study was conducted from May 1 , 2007 to March 30 , 2012 . Patients with uncomplicated groin hernia were r and omized to transabdominal preperitoneal ( TAPP ) or totally extraperitoneal ( TEP ) techniques . A total of 160 patients were r and omized to group I ( TEP ) and 154 patients to group II ( TAPP ) . Pain was assessed with Visual Analogue Scale ( VAS ) preoperatively and postoperatively at 24 h , 1 week , 6 weeks , 3 , 6 , and 12 months , and yearly thereafter . Quality of life was assessed with Short Form–36 version 2 ( SF 36v2 ) preoperatively and postoperatively at 3 months follow-up . Results Demographic , clinical profiles , intraoperative , and early postoperative parameters were well matched . There was significantly higher acute pain following TAPP repair ; however , the chronic groin pain was comparable in both TEP and TAPP . Preoperative pain and immediate postoperative pain had significant correlation with chronic groin pain . Significant improvement from preoperative to postoperative quality of life was seen in both TEP and TAPP repairs , but there was no difference between TEP and TAPP in postoperative period . Time to return to normal activity also was similar between the two groups . Conclusions The TEP and TAPP techniques of laparoscopic repair of inguinal hernia have comparable long-term outcomes in terms of incidence of chronic groin pain , quality of life , and resumption of normal activities . Chronic groin pain had a significant correlation with preoperative pain and early postoperative pain . However , TAPP was associated with significantly higher incidence of early postoperative pain , longer operative time , and cord edema , whereas TEP was associated with a significant higher incidence of seroma formation . The cost was comparable between the two OBJECTIVE To compare outcome and costs between laparoscopic and open hernia repair . DESIGN Prospect i ve r and omised study . SETTING One university and two district hospitals in Sweden . SUBJECTS 200 men aged 25 - 75 years . MAIN OUTCOME MEASURES Operating time , hospital stay , complications , and time to recovery . A cost-minimisation- analysis was used in which the total costs were calculated for a defined period of time for each option . RESULT The one year follow-up rate was 98 % . Mean ( SD ) operation times in the laparoscopic and open groups were 72 ( 30 ) and 62 ( 25 ) minutes , respectively ( p = 0.009 ) . Hospital stay and complication rates did not differ between the groups . Among employees the mean ( SD ) periods off work in the laparoscopic and open groups were 10 ( 8) and 23 ( 21 ) days , respectively ( p = 0.0001 ) . The mean direct costs of the laparoscopic operation were increased by SEK 4037 ( US$ 483 ) but the savings in indirect costs result ing from earlier return to work were SEK 11392 ( US$ 1364 ) . CONCLUSIONS Laparoscopic hernia repair gave the employed patients faster recovery and return to work , and was the most cost-effective strategy provided that both direct and indirect costs were included Practice guidelines are valid if “ they lead to the health gains and costs predicted for them.”1 When implemented , valid guidelines lead to changes in clinical practice and improvements in outcomes for patients .2 - 5 Invalid guidelines , however , may lead to the use of ineffective interventions that waste re sources , or even to harm . Guidelines must offer recommendations for both effective and efficient care , and these have not previously been available in the United Kingdom . We have reported the development and content of guidelines for primary care in the United Kingdom based explicitly on evidence of effectiveness.6 - 9 Here , we present the methods used to develop evidence based guidelines on the use in primary care of four important groups of drugs — angiotensin converting enzyme inhibitors in patients with heart failure , choice of antidepressants , non-steroidal anti-inflammatory drugs in patients with osteoarthritis , and aspirin as an antithrombotic agent.10 - 13 Abridged versions of the guidelines on angiotensin converting enzyme inhibitors , aspirin , and non-steroidal anti-inflammatory drugs will be published in subsequent articles.14 - 16 # # # # Summary points Guideline development groups defined important clinical questions , produced search criteria , and drew up protocol s for systematic review and , where appropriate , meta- analysis Medline and Embase were search ed for systematic review s and meta-analyses , r and omised trials , quality of life studies , and economic studies Meta- analysis was used extensively by the group to answer specific clinical questions Statements on evidence were categorised in relation to study design , reflecting their susceptibility to bias Strength of recommendations was grade d according to the category of evidence and its applicability , economic issues , values of the guideline group and society , and the groups ' awareness of practical issues Recommendations cease to apply in December 1999 , by which time relevant results that may affect recommendations may be known Guideline development groups comprised three broad classes of members — relevant healthcare professionals ( up to five general practitioners ( all with Background : This r and omized controlled trial was design ed to compare the most common technique for open mesh repair ( Lichtenstein ) with the currently preferred minimally invasive technique ( total extra peritoneal , TEP ) for the surgical correction of inguinal hernia . Methods : A total of 660 patients were r and omized to Lichtenstein or TEP procedure . Primary outcomes were postoperative pain , length of hospital stay , period until complete recovery , and quality of life ( QOL ) . Recurrences , operating time , complications , chronic pain , and costs were secondary endpoints . This study was registered at www . clinical trials.gov and carries the ID : NCT00788554 . Results : About 336 patients were r and omized to TEP , and 324 to Lichtenstein repair . TEP was associated with less postoperative pain until 6 weeks postoperatively ( P = 0.01 ) . Chronic pain was comparable ( 25 % vs. 29 % ) . Less impairment of inguinal sensibility was seen after TEP ( 7 % vs. 30 % , P = 0.01 ) . Mean operating time for a unilateral hernia with TEP was longer ( 54 vs. 49 minutes , P = 0.03 ) but comparable for bilateral hernias . Incidence of adverse events during surgery was higher with TEP ( 5.8 % vs. 1.6 % , P < 0.004 ) , but postoperative complications ( 33 % vs. 33 % ) , hospital stay and QOL were similar . After TEP , patients had a faster recovery of daily activities ( ADL ) and less absence from work ( P = 0.01 ) . After a mean follow-up of 49 months , recurrences ( 3.8 % vs. 3.0 % , P = 0.64 ) and total costs ( & U20AC;3.096 vs. & U20AC;3.198 ) were similar . Conclusion : TEP procedure was associated with more adverse events during surgery but less postoperative pain , faster recovery of daily activities , quicker return to work , \n Output:\n " }, { "from": "agent", "value": "Trials using non-restrictive recommendations of 1–2 days or “ as soon as possible to return to all activities ” reported overall a shorter duration of convalescence compared with trials not using recommendations for convalescence .\nStrenuous physical activity at work , strenuous leisure activity and patients with expectations of a prolonged period of convalescence may be risk factors for prolonged convalescence extending more than a few days after laparoscopic inguinal hernia repair .\nShort and non-restrictive recommendations may reduce duration of convalescence without increasing risk of pain , complications or recurrence 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: Abstract Difficulties in the palpation of anatomical l and marks in pregnancy due to obesity may create problems in the regional anaesthesia . Objective of this study was to compare ultrasound examination carried out before the procedure with conventional spinal anaesthesia method with papation of bony l and marks in caesarean sections performed under spinal anaesthesia in obese pregnants . Ninety-seven obese pregnants having pre- and post-pregnancy body mass index > 30 kg/m2 were prospect ively examined . Patients were r and omised to two groups as l and mark group ( n = 49 ) and ultrasound group ( n = 48 ) . The needle insertion point was determined at L4–L5 level before the procedure through palpation in the l and mark group and with the examination in the ultrasound . The numbers of skin punctures and needle passes , total procedure time ( TPT ) and spinal block occurrence time ( SBOT ) were recorded . TPT was significantly longer in the ultrasound than in the l and mark group ( p < 0.001 ) ( 8 ± 2 and 5 ± 1 ; respectively ) . Whereas SBOT values were similar ( p = 0.063 ) . The numbers of skin punctures and needle passes were significantly fewer in the ultrasound than in the l and mark group ( p < 0.001 ) . We believe that , accurate determination of the needle introducing site before the procedure by viewing the vertebral structures through ultrasound examination in obese pregnants could increase the success rate Ultrasound assistance for neuraxial techniques may improve technical performance ; however , it is unclear which population s benefit most . Our study aim ed to investigate the efficacy of neuraxial ultrasound in women having caesarean section with combined spinal‐epidural anaesthesia , and to identify factors associated with improved technical performance . Two‐hundred and eighteen women were r and omly allocated to ultrasound‐assisted or control groups . All the women had a pre‐procedure ultrasound , but only women in the ultrasound group had this information conveyed to the anaesthetist . Primary outcomes were first‐pass success ( a single needle insertion with no redirections ) and procedure difficulty . Secondary outcomes were block quality , patient experience and complications . Exploratory sub‐group analysis and regression analysis were used to identify factors associated with success . Data from 215 women were analysed . First‐pass success was achieved in 67 ( 63.8 % ) and 42 ( 38.2 % ) women in the ultrasound and control groups , respectively ( adjusted p = 0.001 ) . Combined spinal‐epidural anaesthesia was ‘ difficult ’ in 19 ( 18.1 % ) and 33 ( 30.0 % ) women in the ultrasound and control groups , respectively ( adjusted p = 0.09 ) . Secondary outcomes did not differ significantly . Anaesthetists misidentified the intervertebral level by two or more spaces in 23 ( 10.7 % ) women . Sub‐group analysis demonstrated a benefit for ultrasound in women with easily palpable spinous processes ( adjusted p = 0.027 ) . Regression analysis identified use of ultrasound and easily palpable spinous processes to be associated with first‐pass success BACKGROUND Ultrasound imaging of the spine is thought to reduce failed and traumatic neuraxial procedures . Most of the evidence supporting this assumption has been produced in the context of an expert sonographer performing the ultrasound assessment , and it remains unknown whether this technique is useful when used by multiple individual operators . OBJECTIVE To invesstigate the impact of preprocedural spinal ultrasound on the ease of insertion of labour epidurals by a group of trainees . We hypothesised that the ultrasound-assisted technique would improve the ease of insertion when compared with the conventional palpation technique . DESIGN A r and omised controlled trial . SETTING Academic hospital in Toronto , Canada . PARTICIPANTS AND INTERVENTION A group of 17 second-year anaesthesia residents and five anaesthesia fellows underwent a training programme in ultrasound assessment of the spine . Parturients with easily palpable lumbar spines were r and omised to either ultrasound or palpation group . Residents and fellows performed both the assessment ( ultrasound or palpation ) and the epidural procedure . MAIN OUTCOME MEASURES Primary outcome : ease of insertion of epidural catheter composed of the time taken to insert the epidural catheter , number of interspace levels attempted and number of needle passes . Secondary outcomes : total procedural time ( assessment and insertion ) ; first pass success rate ; number of attempts required to thread the epidural catheter ; failure of epidural analgesia ; and patient satisfaction . RESULTS We analysed 128 epidural catheter insertions ( residents 84 , fellows 44 ) . There was no difference in median ( interquartile range , IQR ) epidural insertion time between the ultrasound and palpation groups [ 174 ( 120 to 241 ) versus 180 ( 130 to 322.5 ) s , respectively ; P = 0.14 ] . The number of interspace levels attempted and needle passes were also similar in both groups . The total procedural time was longer in the ultrasound group . CONCLUSION The use of preprocedural spinal ultrasound by a cohort of anaesthesia trainees did not improve the ease of insertion of labour epidural catheters in patients with easily palpable lumbar spines , as compared with the traditional palpation technique based on anatomical l and marks . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT00996905 STUDY OBJECTIVE To assess the clinical use of ultrasonographic localization of the epidural space , and to evaluate the clinical efficacy of ultrasound diagnostics in obstetric anesthesia . DESIGN R and omized prospect i ve study . SETTING University Clinic of Obstetrics and Gynecology . PATIENTS 300 parturients , 85 of whom had conventional delivery and 65 who underwent cesarean section . INTERVENTIONS Patients underwent ultrasonography for the identification of the intervertebral structures . Puncture depth and angle were measured to improve the placement of the Tuohy needle . MEASUREMENTS In the ultrasound group , additional puncture data , optimized puncture point , expected puncture depth , and angle were used to optimize the puncture technique . To control for side effects , we compiled data on the number of puncture attempts and the number of necessary puncture levels , visual analog scale ( VAS ) scores , the rate of side effects , and the patient acceptance of the technique . MAIN RESULTS The two groups were similar regarding demographic data . Using ultrasound for structure detection , the rate of puncture attempts were significantly ( p < 0.013 ) reduced from 2.18 + /- 1.07 to 1.35 + /- 0.61 . The mean rate of necessary puncture levels was 1.30 + /- 0.55 and with ultrasound detection 1.136 + /- 0.36 ( p < 0.029 ) . Complete analgesia was achieved in 147 patients with ultrasound detection versus 138 patients in the Control group ( p < 0,03 ) . The maximum VAS pain score in the control group was 1.3 + /- 2.1 versus 0.8 + /- 1.5 in the Ultrasound group ( p < 0.006 ) . The rate of side effects were reduced significantly : 99 patients in the Control group had no side effects compared with 120 patients from the Ultrasound group who were free of side effects . Patient acceptance of the technique in the Ultrasound group was significantly higher than in the Control group . CONCLUSION The clinical use of ultrasound for epidural catheter placement may improve regional anesthesia . The use of ultrasound result ed in superior quality in all measured endpoints Palpation method is widely used in clinical practice to identify the puncture site during combined spinal-epidural ( CSE ) blocks . Tuffier ’s line , is an anatomical l and mark between two iliac crests ( inter-cristal ) , which is widely used to identify the puncture site during CSE blocks is not always an indicator for specific vertebral level or inter-vertebral space . One hundred and Ten ( 110 ) women were scheduled for normal vaginal delivery and were r and omized into two equal groups ; palpation group and an ultrasound guided group to detect the efficacy of puncture ultrasound before CSE blocks to increase chances of successful CSE procedure on the first attempt and to reduce the number of attempts or punctures during insertion of CSE catheter . There were no significant differences between two studied groups regarding ; maternal age , weight and height , while , there was a significant difference between two studied groups regarding ; parity . Percentage of successful CSE procedure on the first attempt was significantly higher ( 67.27 % ) in ultrasound compared to palpation group ( 40 % ) . Number of punctures ( attempts ) were significantly less in ultrasound ( 1.2 ± 0.6 ) compared to palpation group ( 2.3 ± 0.8 ) and the number of redirections was also significantly less in ultrasound ( 1.4 ± 0.5 ) compared to palpation group ( 2.8 ± 1.6 ) . Although , time to identify puncture site was significantly longer in ultrasound compared to palpation group and total procedure time was longer in ultrasound ( 9.1 ± 1.5 min ) compared to palpation group ( 6.2 ± 1.2 min ) , there was no significant difference between two studied groups regarding ; time to identify puncture site and total procedure time . Two cases of dural puncture in palpation versus no cases in ultrasound group and two cases of intravascular catheter placement ( one in each group ) , with no significant difference between two groups . Pre- puncture ultrasound guided epidural insertion before vaginal delivery , increases the chance of a successful CSE procedure on the first attempt and reduces the number of attempts during insertion of CSE catheter BACKGROUND Data are scarce on the advantage of ultrasound-guided spinal anaesthesia in patients with easily identifiable bony l and marks . In this study , we compared the use of ultrasound to the l and mark method in patients with no anticipated technical difficulty , presenting for caesarean delivery under spinal anaesthesia . METHODS A total of 150 pregnant women were recruited in this r and omized , controlled study . Ultrasound examination and spinal anaesthesia were performed by three anaesthetists with experience in ultrasound-guided neuraxial block . Patients were r and omized to either the Ultrasound Group ( n=75 ) or the L and mark Group ( n=75 ) . In both groups the level of L3 - 4 or L4 - 5 was identified by ultrasound ( transverse and longitudinal approach ) or palpation . The primary outcome was the procedure time , measured from the time of skin puncture by the introducer to the time of viewing cerebrospinal fluid at the hub of the spinal needle . Secondary outcomes were the number of skin punctures , number of passes , and incidence of successful spinal blockade . RESULTS The average procedure time , number of skin punctures and needle passes , were similar in both groups . The number of patients with successful spinal anaesthesia after one puncture was not statistically different between the groups . CONCLUSION The present results indicate that when performed by anaesthetists experienced in both ultrasound and l and mark techniques , the use of ultrasound does not appear to increase the success rate of spinal anaesthesia , or reduce the procedure time or number of attempts in obstetric patients with easily palpable spines Background and Aims : Identification of subarachnoid space in pregnant patients can pose a great challenge to anaesthesiologists . This study was design ed to compare conventional l and mark technique with pre-procedural ultrasonography-assisted midline approach for identification of the subarachnoid space in elective caesarean section . Methods : After institute ethics committee approval and written informed consent , 100 parturients scheduled for elective caesarean section under spinal anaesthesia were included in this prospect i ve r and omised control trial and divided into Group L ( n = 50 ) ( l and mark technique ) and Group U ( n = 50 ) ( ultrasound-guided technique ) . Parameters such as time taken for the identification of the interspace , distance between skin and dura mater , number of insertion attempts ( the primary outcome ) , number of passes and time taken were recorded in both the groups . Statistical analysis was done using SPSS software 16 . Results : Demographic profiles of both groups were comparable . The number of attempts for needle insertion ( 1.04 ± 0.19 vs. 1.97 ± 0.77 ) , number of passes in the same interspinous space ( 1.26 ± 0.44 vs. 1.90 ± 0.51 ) and the total time for successful lumbar puncture ( 31.90 ± 6.30 vs. 51.80 ± 12.28 s ) were significantly less in Group U as compared to Group L , but the time of identification of interspinous space was significantly more in Group U ( 56.70 ± 13.08 s ) as compared to Group L ( 47.10 ± 10.45 s ) . Conclusion : Pre-procedural ultrasound is a useful tool for successful lumbar puncture in parturients as it reduces the number of attempts with fewer side effects as compared to conventional l and mark technique STUDY OBJECTIVE This r and omized controlled trial was design ed to evaluate the efficacy of additional information from preprocedure ultrasound examination to aid anesthesiology trainees performing spinal anesthesia for obstetric patients . DESIGN Trainee residents were r and omly allocated to \n Output:\n " }, { "from": "agent", "value": "The primary results showed that preprocedural ultrasound increased the FPS rate in patients with predicted puncture difficulty but not in patients who were easily punctured .\nPreprocedural ultrasound reduced the number of redirections and punctures and decreased the incidence of vascular puncture and backache .\nThere was no evidence of a reduction in failed punctures .\nWe also noted that preprocedural ultrasound prolonged the identification time but not the procedure time .\nThus , this systematic review provides evidence that preprocedural ultrasound does not improve the FPS rate of neuraxial anesthesia in patients who are easily palpated , although it increases the FPS rate in patients who are difficult to palpate" } ]

[ { "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 Background Systemic endothelial dysfunction has been identified as one of the main events in preeclampsia ( PE ) . A nonhealthy vascular endothelium can be pointed out as the pathophysiological explanation of the clinical manifestations and complications of PE . Once normal pregnancy is characterized by a constant increase in endothelial function , a follow-up of this physiological event could be used as an early marker or a prediction tool to predict PE . Objectives To perform a longitudinal assessment of endothelial function , using an ultrasound study of brachial artery flow Flow-mediated dilation ( FMD ) , in normotensive and preeclamptic pregnancies , to evaluate the difference of FMD values along the second trimester of pregnancy to predict PE . Patients and methods In a prospect i ve cohort study , 91 pregnant women with a high risk of developing PE were subjected to FMD of the brachial artery . The difference in the FMD values , between 16 + 0 and 19 + 6 and 24 + 0 and 27 + 6 weeks of gestation were compared , taking PE development into consideration . Receiver operator characteristics ( ROC ) curves were created to determine the sensibility and specificity of FMD difference to predict PE . Results A total of 19 patients developed PE and the other 72 women remained normotensive until 1 week after delivery . When considering a cut off of + 2.50 % , FMD difference , between the two evaluations , sensitivity for PE prediction was 87.5 % for early onset PE and 95.5 % for late PE . Conclusion The difference of FMD values between the second trimester of pregnancy can be used for PE prediction for both , early and late forms of PE Background Preterm preeclampsia is an important cause of maternal and perinatal death and complications . It is uncertain whether the intake of low‐dose aspirin during pregnancy reduces the risk of preterm preeclampsia . Methods In this multicenter , double‐blind , placebo‐controlled trial , we r and omly assigned 1776 women with singleton pregnancies who were at high risk for preterm preeclampsia to receive aspirin , at a dose of 150 mg per day , or placebo from 11 to 14 weeks of gestation until 36 weeks of gestation . The primary outcome was delivery with preeclampsia before 37 weeks of gestation . The analysis was performed according to the intention‐to‐treat principle . Results A total of 152 women withdrew consent during the trial , and 4 were lost to follow up , which left 798 participants in the aspirin group and 822 in the placebo group . Preterm preeclampsia occurred in 13 participants ( 1.6 % ) in the aspirin group , as compared with 35 ( 4.3 % ) in the placebo group ( odds ratio in the aspirin group , 0.38 ; 95 % confidence interval , 0.20 to 0.74 ; P=0.004 ) . Results were material ly unchanged in a sensitivity analysis that took into account participants who had withdrawn or were lost to follow‐up . Adherence was good , with a reported intake of 85 % or more of the required number of tablets in 79.9 % of the participants . There were no significant between‐group differences in the incidence of neonatal adverse outcomes or other adverse events . Conclusions Treatment with low‐dose aspirin in women at high risk for preterm preeclampsia result ed in a lower incidence of this diagnosis than placebo . ( Funded by the European Union Seventh Framework Program and the Fetal Medicine Foundation ; EudraCT number , 2013‐003778‐29 ; Current Controlled Trials number , IS RCT N13633058 . This pilot aims to better underst and the market for childcare in Saudi Arabia – both the supply and dem and sides – and to design a r and omized controlled experiment to test whether access to affordable day care ( in the form of subsidies , for example ) would incentivize Saudi mothers to search actively for employment and to remain employed once they are hired . In addition , the study seeks to underst and the degree to which employment early on in one ’s life impacts employment in later stages . The pilot will provide information on the groups of women the experiment should target , appropriate levels for the childcare subsidy , and the quality and current geographic locations of daycare sites . Expected Impact Determine the effects of facilitating childcare access on Saudi women ’s employment . PRINCIPAL INVESTIGATORS  Boston University Patricia Cortes  Harvard University Claudia Goldin  Swarthmore College Jennifer Background — Preeclampsia is a life-threatening pregnancy syndrome of uncertain origin . To eluci date the pathogenesis , we evaluated the temporal relationships between changes in vascular function and circulating biomarkers of angiogenic activity before and after the onset of preeclampsia and gestational hypertension . Methods and Results — Maternal mean arterial pressure , uterine artery pulsatility index , brachial artery flow-mediated dilatation , and serum concentrations of placental growth factor ( PlGF ) , soluble fms-like tyrosine kinase 1 ( sFlt-1 ) , and soluble endoglin were prospect ively measured in 159 women from 10 weeks gestation until 12 weeks postpartum . At 10 to 17 weeks , women who developed preterm preeclampsia had lower serum PlGF ( P=0.003 ) , higher soluble endoglin ( P=0.006 ) , and higher sFlt-1:PlGF ratio ( P=0.005 ) compared with women who later developed term preeclampsia , gestational hypertension , or normotensive pregnancy . At 10 to 17 weeks , mean arterial pressure inversely correlated with serum PlGF ( r=−0.19 , P=0.02 ) ; at 18 to 25 weeks , with soluble endoglin ( r=0.18 , P=0.02 ) ; and at 26 to 33 weeks , with sFlt-1 ( r=0.28 , P<0.001 ) . At 23 to 25 weeks , uterine artery pulsatility index correlated with serum soluble endoglin ( r=0.19 , P=0.02 ) and sFlt-1 levels ( r=0.17 , P=0.03 ) . Flow-mediated dilatation was higher during a pregnancy with gestational hypertension compared with preeclampsia ( P=0.001 ) . Twelve weeks postpartum , serum PlGF was higher in women who had a hypertensive pregnancy compared with a normotensive pregnancy ( P<0.001 ) . Conclusions — These observations support a role for placenta-derived angiogenic biomarkers in the control of maternal vascular resistance of preeclampsia . Gestational hypertension develops differently , with a hyperdynamic circulation and angiogenic biomarker profile similar to normotensive pregnancy . Larger studies of unselected women are needed to ascertain whether measures of these angiogenic biomarkers assist with the prediction and prognosis of preeclampsia and whether postpartum measures of serum PlGF have a role in predicting future cardiovascular disease Background — Coronary artery calcium ( CAC ) has been demonstrated to be associated with the risk of coronary heart disease . The Multi-Ethnic Study of Atherosclerosis ( MESA ) provides a unique opportunity to examine the distribution of CAC on the basis of age , gender , and race/ethnicity in a cohort free of clinical cardiovascular disease and treated diabetes . Methods and Results — MESA is a prospect i ve cohort study design ed to investigate sub clinical cardiovascular disease in a multiethnic cohort free of clinical cardiovascular disease . The percentiles of the CAC distribution were estimated with nonparametric techniques . Treated diabetics were excluded from analysis . There were 6110 included in the analysis , with 53 % female and an average age of 62 years . Men had greater calcium levels than women , and calcium amount and prevalence were steadily higher with increasing age . There were significant differences in calcium by race , and these associations differed across age and gender . For women , whites had the highest percentiles and Hispanics generally had the lowest ; in the oldest age group , however , Chinese women had the lowest values . Overall , Chinese and black women were intermediate , with their order dependent on age . For men , whites consistently had the highest percentiles , and Hispanics had the second highest . Blacks were lowest at the younger ages , and Chinese were lowest at the older ages . At the MESA public website ( http://www.mesa-nhlbi.org ) , an interactive form allows one to enter an age , gender , race/ethnicity , and CAC score to obtain a corresponding estimated percentile . Conclusions — The information provided here can be used to examine whether a patient has a high CAC score relative to others with the same age , gender , and race/ethnicity who do not have clinical cardiovascular disease or treated diabetes Preeclampsia is a leading cause of maternal morbidity and mortality . The degree of maternal cardiovascular dysfunction that precedes the onset of preeclampsia is largely unknown . This prospect i ve cohort study aim ed to characterize differences in vivo in retinal microvascular caliber and blood pressure throughout pregnancy in relation to preeclampsia development . Women were recruited from Royal Prince Alfred Hospital , Sydney , Australia , of which 92 women were included in the study . Retinal images and blood pressures were collected at 13 , 19 , 29 , and 38 weeks of gestation . Retinal vessels were analyzed as the central retinal arteriolar equivalent corrected for mean arterial blood pressure and the central retinal venular equivalent corrected for mean arterial blood pressure , using generalized linear models adjusted for age and body mass index . The preeclampsia group were significantly older ( P=0.002 ) and had a significantly higher mean body mass index ( P=0.005 ) . The central retinal arteriolar equivalent corrected for mean arterial blood pressure was significantly reduced at 13 ( P=0.03 ) , 19 ( P=0.007 ) , and 38 ( P=0.03 ) weeks of gestation in the preeclampsia group . The central retinal venular equivalent corrected for mean arterial blood pressure was also significantly lower at 13 ( P=0.04 ) and 19 ( P=0.001 ) weeks of gestation in the women who progressed to preeclampsia . This study directly documents increased peripheral resistance in vivo , observed as the combination of constricted retinal arterioles or venules and elevated blood pressure , in women who later developed preeclampsia . This difference preceded the clinical signs of preeclampsia OBJECTIVES The purpose of this study was to determine the prognostic accuracy of electron beam computed tomographic ( CT ) scanning of the coronary arteries and the relationship of coronary calcification to st and ard coronary disease risk factors and C-reactive protein ( CRP ) in the prediction of atherosclerotic cardiovascular disease ( ASCVD ) events in apparently healthy middle-age persons . BACKGROUND As a screening test for coronary artery disease ( CAD ) , electron beam CT scanning remains controversial . METHODS In a prospect i ve , population -based study , 4,903 asymptomatic persons age 50 to 70 years underwent electron beam CT scanning of the coronary arteries . RESULTS At 4.3 years , follow-up was available in 4,613 participants ( 94 % ) , and 119 had sustained at least one ASCVD event . Subjects with ASCVD events had higher baseline coronary calcium scores ( median [ interquartile range ] , Agatston method ) than those without events : 384 ( 127 , 800 ) versus 10 ( 0 , 86 ) ( p < 0.0001 ) . For coronary calcium score threshold > or = 100 versus < 100 , relative risk ( 95 % confidence interval ) was 9.6 ( 6.7 to 13.9 ) for all ASCVD events , 11.1 ( 7.3 to 16.7 ) for all CAD events , and 9.2 ( 4.9 to 17.3 ) for non-fatal myocardial infa rct ion and death . The coronary calcium score predicted CAD events independently of st and ard risk factors and CRP ( p = 0.004 ) , was superior to the Framingham risk index in the prediction of events ( area under the receiver-operating characteristic curve of 0.79 + /- 0.03 vs. 0.69 + /- 0.03 , p = 0.0006 ) , and enhanced stratification of those falling into the Framingham categories of low , intermediate , and high risk ( p < 0.0001 ) . CONCLUSIONS The electron beam CT coronary calcium score predicts CAD events independent of st and ard risk factors , more accurately than st and ard risk factors and CRP , and refines Framingham risk stratification OBJECTIVES To assess the evolution of the soluble fms-like tyrosine kinase-1 ( sFlt-1 ) to placental growth factor ( PlGF ) ratio in women with suspected or confirmed pre-eclampsia ( PE ) , and to investigate the changes in sFlt-1 and PlGF levels in pre-eclamptic women after delivery . METHODS This was an exploratory study in which secondary analysis was performed on a prospect i ve cohort study that enrolled women with a singleton pregnancy and suspected or confirmed PE from 18 weeks ' gestation , carried out between December 2013 and April 2016 at the Department of Obstetrics of the Erasmus Medical Center in Rotterdam . sFlt \n Output:\n " }, { "from": "agent", "value": "Accelerated coronary calcification and plaque deposition was identified , with greater rates of increased calcium scores and sub clinical coronary artery disease shown by CTCA in women with a history of pre-eclampsia at 30 years postpartum .\nThe evidence was less conclusive for the persistence of long-term endothelial dysfunction ." } ]

[ { "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 total of 105 “ high‐risk ” infants born in 1988 were studied prospect ively from birth to 18 months of age . The infants were recommended breastfeeding and /or hypoallergenic formula ( Nutramigen or Profylac ) combined with avoidance of solid foods during the first 6 months of life . All mothers had unrestricted diet . Avoidance of daily exposure to tobacco smoke , furred pets and dust‐collecting material s in the bedroom were advised . This prevention group was compared with a control group consisting of 54 identically defined “ high‐risk ” infants born in 1985 in the same area . All infants had either severe single atopic predisposition combined with cord blood IgE ≥ 0.5 KU/1 or biparental atopic predisposition . The control group had unrestricted diet and was not advised about environmental factors . Apart from the prevention programme and year of birth the prevention group and the control group were comparable . The parents were highly motivated and compliance was good . The rate of participation was 97 % , and 85 % followed the dietary measures strictly . The cumulative prevalence of atopic symptoms was significantly lower at 18 months in the prevention group ( 32 % ) , as compared with the control group ( 74 % ) ( p<0.01 ) , due to reduced prevalence of recurrent wheezing ( 13 % , versus 37 % ; p<0.01 ) , atopic dermatitis ( 14 % versus 31 % ; p<0.01 ) , vomiting/diarrhoea ( 5 % versus 20 % ; p<0.01 ) and infantile colic ( 9 % versus 24 % ; p<0.01 ) . The cumulative prevalence of food allergy was significantly lower in the prevention group ( 6 % versus 17 % ; p<0.05 ) . In both high‐risk groups daily exposure to tobacco smoke increased the risk of recurrent wheezing significantly ( p<0.01 ) . The main difference between the prevention group and the control group was the diet . Thus , feeding with breastmilk and /or hypoallergenic formula combined with avoidance of solid foods until the age of 6 months appeared to reduce the cumulative prevalence of atopic symptoms during the first 18 months of life We have previously reported a protective effect of maternal omega-3 long-chain polyunsaturated fatty acids ( ω-3 LCPUFA ) supplementation in pregnancy and lactation on IgE-associated eczema and food allergy in the infant during the first year of life . Here we investigate whether the effects of the LCPUFA supplementation on IgE-associated diseases last up to 2 yr of age and assess the relationship between plasma proportions of ω-3 PUFAs and the frequency and severity of infant allergic disease . 145 pregnant women , at risk of having an allergic infant , were r and omized to daily supplementation with 1.6 g eicosapentaenoic acid ( EPA ) and 1.1 g docosahexaenoic acid ( DHA ) or placebo starting in the 25th gestational week and continuing through 3.5 months of breastfeeding . Clinical examinations , skin prick tests and analysis of maternal and infant plasma phospholipid fatty acids and infant specific IgE were performed . No difference in the prevalence of allergic symptoms was found between the intervention groups . The cumulative incidence of IgE-associated disease was lower in the ω-3-supplemented group ( 6/54 , 13 % ) compared with the placebo group ( 19/62 , 30 % , p=0.01 ) . Higher maternal and infant proportions of DHA and EPA were associated with lower prevalence of IgE associated disease ( p=0.01 - 0.05 ) in a dose-dependent manner . Higher maternal and infant proportions of DHA and EPA were found if the infants presented none , when compared with multiple allergic symptoms , ( p<0.05 ) regardless of sensitization . In summary , the ω-3 supplementation offered no obvious preventive effect on the prevalence of clinical symptoms of allergic disease , but the decrease in cumulative incidence of IgE-associated disease seen during the first year still remained until 2 yr of age . Furthermore , high proportions of DHA and EPA in maternal and infant plasma phospholipids were associated with less IgE-associated disease and a reduced severity of the allergic phenotype BACKGROUND Partially hydrolyzed whey formula ( pHWF ) has been recommended for infants with a family history of allergic disease at the cessation of exclusive breast-feeding to promote oral tolerance and prevent allergic diseases . OBJECTIVE To determine whether feeding infants pHWF reduces their risk of allergic disease . METHODS A single-blind ( participant ) r and omized controlled trial was conducted to compare allergic outcomes between infants fed a conventional cow 's milk formula , a pHWF , or a soy formula . Before birth , 620 infants with a family history of allergic disease were recruited and r and omized to receive the allocated formula at cessation of breast-feeding . Skin prick tests to 6 common allergens ( milk , egg , peanut , dust mite , rye grass , and cat d and er ) were performed at 6 , 12 , and 24 months . The primary outcome was development of allergic manifestations ( eczema and food reactions ) measured 18 times in the first 2 years of life . RESULTS Follow-up was complete for 93 % ( 575/620 ) at 2 years and 80 % ( 495/620 ) at 6 or 7 years of age . There was no evidence that infants allocated to the pHWF ( odds ratio , 1.21 ; 95 % CI , 0.81 - 1.80 ) or the soy formula ( odds ratio , 1.26 ; 95 % CI , 0.84 - 1.88 ) were at a lower risk of allergic manifestations in infancy compared with conventional formula . There was also no evidence of reduced risk of skin prick test reactivity or childhood allergic disease . CONCLUSION Despite current dietary guidelines , we found no evidence to support recommending the use of pHWF at weaning for the prevention of allergic disease in high-risk infants BACKGROUND Maternal diet during pregnancy might be one of the factors that influences fetal immune responses associated with childhood allergy . OBJECTIVE We analyzed the association between maternal diet during the last 4 wk of pregnancy and allergic sensitization and eczema in the offspring at 2 y of age . DESIGN Data from 2641 children at 2 y of age were analyzed within a German prospect i ve birth cohort study ( LISA ) . Maternal diet during the last 4 wk of pregnancy was assessed with a semiquantitative food-frequency question naire , which was administered shortly after childbirth . RESULTS High maternal intake of margarine [ adjusted odds ratio ( aOR ) : 1 . 49 ; 95 % CI : 1.08 , 2.04 ] and vegetable oils ( aOR : 1.48 ; 95 % CI : 1.14 , 1.91 ) during the last 4 wk of pregnancy was positively associated and high maternal fish intake ( aOR : 0.75 ; 95 % CI : 0.57 , 0.98 ) was inversely associated with eczema during the first 2 y in the offspring . High celery ( aOR : 1.85 ; 95 % CI : 1.18 , 2.89 ) and citrus fruit ( aOR : 1.73 ; 95 % CI : 1.18 , 2.53 ) intakes increased the risk of sensitization against food allergens . In turn , sensitization against inhalant allergens was positively related to a high maternal intake of deep-frying vegetable fat ( aOR : 1.61 ; 95 % CI : 1.02 , 2.54 ) , raw sweet pepper ( aOR : 2.16 ; 95 % CI : 1.20 , 3.90 ) , and citrus fruit ( aOR : 1.72 ; 95 % CI : 1.02 , 2.92 ) . CONCLUSIONS We suggest that the intake of allergenic foods and foods rich in n-6 polyunsaturated fatty acids during pregnancy may increase and foods rich in n-3 polyunsaturated fatty acids may decrease the risk of allergic diseases in the offspring BACKGROUND Early feeding with cow 's milk ( CM ) may increase the risk of cow 's milk allergy ( CMA ) . OBJECTIVE We sought to examine prospect ively whether supplementary feeding of CM at the maternity hospital would increase the risk when compared with feeding with pasteurized human milk or hydrolyzed formula . METHODS We studied 6209 unselected healthy , full-term infants , of whom 5385 ( 87 % ) required supplementary milk while in the hospital . The infants were r and omly assigned to receive CM formula ( 1789 infants ) , pasteurized human milk ( 1859 infants ) , or whey hydrolysate formula ( 1737 infants ) . The comparison group ( 824 infants ) was composed of infants who were exclusively breast-fed . The infants were followed for 18 to 34 months for symptoms suggestive of CMA . The primary endpoint was a challenge-proven adverse reaction to CM after a successful CM elimination diet . RESULTS The cumulative incidence of CMA in the infants fed CM was 2.4 % compared with 1.7 % in the pasteurized human milk group ( odds ratio [ OR ] , 0.70 ; 95 % confidence interval [ CI ] , 0 . 44 - 1.12 ) and 1.5 % in the whey hydrolysate group ( OR , 0.61 ; 95 % CI , 0 . 38 - 1.00 ) . In the comparison group , CMA developed in 2.1 % of the infants . Among the infants who required supplementary feeding at hospital , both exposure to CM while in the hospital ( OR , 1.54 ; 95 % CI , 1.04 - 2.30 ; P = .03 ) and obvious parental atopy ( OR , 2.32 ; 95 % CI , 1.53 - 3.52 ; P < .001 ) increased the risk of CMA . CONCLUSIONS Our data indicate that feeding of CM at maternity hospitals increases the risk of CMA when compared with feeding of other supplements , but exclusive breast-feeding does not eliminate the risk The aim of this study was to assess the preventive effect of exclusive breast-feeding and early solid food avoidance on atopic dermatitis ( AD ) in infancy . This study is part of a dietary clinical trial in a prospect i ve cohort of healthy term newborns at risk of atopy . It was recommended to breast-feed for at least 4 months and to avoid solid food in the same time-period . Eight hundred and sixty-five infants exclusively breast-fed , and 256 infants partially or exclusively formula-fed , were followed-up until the end of the first year following birth . AD and sensitization to milk and egg were considered as study end-points . The 1-year incidence of AD was compared between the two study groups . Adjusted odds ratios ( OR ) with 95 % confidence intervals ( CI ) were calculated by multiple logistic regression . The incidence of AD was calculated in relation to age at introduction of solid food and amount of food given . In the breast-fed group , the adjusted OR for AD was 0.47 ( 95 % CI 0.30 - 0.74 ) . The strongest risk factor was the occurrence of AD in the subject 's core family . The risk of infants with AD to be sensitized to milk was four times higher , and to egg eight times higher , than in infants without AD . Age at first introduction of solid food and diversity of solid food showed no effect on AD incidence . We conclude that in infants at atopic risk , exclusive breast-feeding for at least 4 months is effective in preventing AD in the first year of life This prospect i ve , long-term study assessed the effects of a protein hydrolysate formula on allergy prevention in infants with a family history of allergy . Infants were r and omly assigned to receive either the hydrolysate formula ( n = 92 ) or an adapted cow milk formula ( n = 85 ) alone or with breast-feeding for 4 months . The groups did not differ in family allergy history scores or cord blood IgE levels . After 4 months , total IgE levels and allergic reactions did not differ significantly between groups , although the hydrolysate group had a lower prevalence of eczema . At 12 months of age , neither IgE levels nor allergic reactions were significantly different . At 2 years of age , however , 18 allergic reactions had occurred in the hydrolysate group and 31 had occurred in the control group ; the differences were significant for eczema ( p < 0.001 ) but not for asthma . At 4 years of age , allergic signs were found in 11 children in the hydrolysate group and in 17 children in the control group ; the difference was significant only for eczema ( p < 0.01 ) . These results suggest that early feeding of a protein hydrolysate formula to infants at risk for allergies had a long-term preventive effect on the prevalence of eczema but not of asthma In a prospect i ve study of a 1-year birth cohort of 158 high-risk infants the effect of feeding breastmilk , a casein hydrolysate ( Nutramigen ) or a new ultrafil \n Output:\n " }, { "from": "agent", "value": "There was no good evidence to recommend that pregnant or breastfeeding women should change their diet or take supplements to prevent allergies in infants at high or normal risk .\nThere were mixed findings about the preventive benefits of breastfeeding for infants at high or normal risk , but there was evidence to recommend avoiding cow 's milk and substituting with extensively or partially hydrolyzed whey or casein formulas for infants at high risk for the first 4 months .\nSoy milk and delaying the introduction of solid foods beyond 4 months did not have preventive benefits in those at high or normal risk .\nThere was very little evidence about strategies for preventing food allergy in older children or 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: BACKGROUND CONTEXT Few studies have analyzed the results of an interspinous distraction device in patients with lumbar spinal stenosis . It is still unknown whether the outcomes of an interspinous implant are related to the severity of stenosis . PURPOSE To determine the success rate of the Aperius implant and open decompression with the aim of defining better the indications for the two modalities of treatment . STUDY DESIGN Comparison of two cohorts of patients with moderate or severe stenosis treated with the Aperius or by open decompression . PATIENT SAMPLE The sample comprises 36 patients who had the Aperius implant and 35 who underwent open decompression , both groups followed prospect ively . In the two cohorts , central or lateral stenosis was present in similar proportions , and in both , the patients had pure intermittent claudication or symptoms at rest and on walking . In both groups , preoperative diagnosis was made by magnetic resonance imaging ( MRI ) . OUTCOME MEASURES Patients of both groups were evaluated with the Zurich Claudication Question naire ( ZCQ ) and Oswestry Disability Index . The results were rated as good or poor based on the ZCQ . METHODS The patients of both cohorts were evaluated at 1 month and 3 , 6 , and 12 months after operation , the final follow-up being carried out at least 2 years after surgery . Severity of stenosis was determined based on preoperative MRI scans . In 17 patients of the Aperius group , MRI studies were repeated at the 6-month or final follow-up and compared with the preoperative studies . RESULTS Of the patients in the Aperius group , six had removal of the implant and open surgical decompression at 2 to 17 months after operation ; these patients were considered to have a poor result . At the final follow-up , the result was rated as good in 47 % of all patients who had had the Aperius implant . The percentage of good outcomes was 60 % in moderate stenosis and 31 % in severe stenosis . When considering all not reoperated patients , 57 % had good outcomes ; however , if only the scores in the patient satisfaction domain of the ZCQ were considered , 67 % of these patients were somewhat satisfied with the result of Aperius . No significant relationship was found between patients with pure intermittent claudication and those with leg symptoms also at rest . In 71 % of cases in which preoperative and postoperative MRIs were compared , no significant change in size of the spinal canal was found after operation , whereas in the remaining patients a slight increase in size of the canal was detected . In the open decompression cohort , the results were good in 80 % of cases and poor in 20 % . The outcomes were satisfactory in 69 % of moderate stenosis , with no significant difference with the similar subgroup of the Aperius series . In severe stenosis , the 89 % rate of good results was significantly higher than in the severe Aperius subgroup ( p<.0001 ) . CONCLUSIONS The Aperius interspinous implant is poorly indicated for severe lumbar stenosis , which is significantly improved only in a small minority of cases , whereas decompression procedures ensure high chances of good results . The implant may be indicated for selected patients with moderate stenosis . The outcomes of the Aperius are not influenced by the type of clinical presentation of lumbar stenosis Purpose Interspinous process devices ( IPDs ) are implanted to treat patients with intermittent neurogenic claudication ( INC ) based on lumbar spinal stenosis . It is hypothesized that patients with lumbar spinal stenosis treated with IPD have a faster short-term recovery , an equal outcome after 2 years and less back pain compared with bony decompression . Methods A r and omized design with variable block sizes was used , with allocations stratified according to center . Allocations were stored in prepared opaque , coded and sealed envelopes , and patients and research nurses were blind throughout the follow-up . Five neurosurgical centers ( including one academic and four secondary level care centers ) included participants . 211 participants were referred to the Leiden – The Hague Spine Prognostic Study Group . 159 participants with INC based on lumbar spinal stenosis at one or two levels with an indication for surgery were r and omized into two groups . Patients and research nurses were blinded for the allocated treatment throughout the study period . 80 participants received an IPD and 79 participants underwent spinal bony decompression . The primary outcome at long-term ( 2-year ) follow-up was the score for the Zurich Claudication Question naire . Repeated measurement analyses were applied to compare outcomes over time . Results At two years , the success rate according to the Zurich Claudication Question naire for the IPD group [ 69 % ( 95 % CI 57–78 % ) ] did not show a significant difference compared with st and ard bony decompression [ 60 % ( 95 % CI 48–71 % ) p value 0.2 ] . Reoperations , because of absence of recovery , were indicated and performed in 23 cases ( 33 % ) of the IPD group versus 6 ( 8 % ) patients of the bony decompression group ( p < 0.01 ) . Furthermore , long-term VAS back pain was significantly higher [ 36 mm on a 100 mm scale ( 95 % CI 24–48 ) ] in the IPD group compared to the bony decompression group [ 28 mm ( 95 % CI 23–34 ) p value 0.04 ] . Conclusions This double-blinded study could not confirm the advantage of IPD without bony decompression over conventional ‘ simple ’ decompression , two years after surgery . Moreover , in the IPD treatment arm , the reoperation rate was higher and back pain was even slightly more intense compared to the decompression treatment arm OBJECT To assess the safety and efficacy of the DIAM implant , the authors compared the mean 12-month outcomes in patients who underwent lumbar surgery with DIAM placement and in those who underwent lumbar surgery only . METHODS Of 62 patients who underwent simple lumbar surgery ( laminectomy and /or microdiscectomy ) in a 24-month period , 31 underwent concomitant surgical placement of a DIAM interspinous process spacer ( 33 devices total ) . Radiographic imaging , pain scores , and clinical assessment s were obtained postoperatively to a mean of 12 months ( range 8 - 25 months ) . Patients who did not undergo implantation of an interspinous process spacer ( Group C ) were compared with and stratified against patients who underwent placement of a DIAM implant ( Group D ) . In Group D , no statistically significant differences were noted in anterior or posterior disc height when comparing patients pre- and postoperatively . Compared with Group C , a relative kyphosis of less than 2 degrees was noted on postoperative images obtained in Group D. No statistically significant differences in visual analog scale ( VAS ) pain scores or MacNab outcomes were noted between Groups C and D at a mean of 12 months of follow up . Complications in Group D included three intraoperative spinous process fractures and one infection . CONCLUSIONS After simple lumbar surgery , the placement of a DIAM interspinous process spacer did not alter disc height or sagittal alignment at the mean 12-month follow-up interval . No adverse local or systemic reaction to the DIAM was noted . No difference in VAS or MacNab outcome scores was noted between the groups treated with or without the DIAM implants , particularly when the DIAM was used to alleviate low-back pain Study Design . Prospect i ve r and omized controlled study . Objective . To compare the outcome of indirect decompression by means of the X-Stop ( Medtronics Inc. , Minneapolis , MN ) implant with conventional decompression in patients with neurogenic intermittent claudication due to lumbar spinal stenosis . Summary of Background Data . Decompression is currently the “ gold st and ard ” for lumbar spinal stenosis but is afflicted with complications and a certain number of dissatisfied patients . Interspinous implants have been on the market for more than 10 years , but no prospect i ve study comparing its outcome with decompression has been performed . Methods . After power calculation , 100 patients were included : 50 in the X-Stop group and 50 in the decompression group . Patients with symptomatic 1- or 2-level lumbar spinal stenosis and neurogenic claudication relieved on flexion were included . X-Stop operations were performed under local anesthesia . The mean patient age was 69 ( 49–89 ) years , and the male/female distribution was 56/44 . Minimal dural sac area was in all cases except two 80 mm2 or less . The noninferiority hypothesis included 6 , 12 , and 24 months of follow-up , and included . intention-to-treat as well as as-treated analyses . The primary outcome meansure was the Zürich Claudication Question naire , and the secondary outcome measures was the visual analogue scale pain , Short-Form 36 ( SF-36 ) , complications , and reoperations . Results . The primary and secondary outcome measures of patients in both groups improved significantly . The results were similar at 6 , 12 , and 24 months and at no time point could any statistical difference between the 2 types of surgery be identified . Three patients ( 6 % ) in the decompression group underwent further surgery , compared with 13 patients ( 26 % ) in the X-Stop group ( P = 0.04 ) . Results were identical in intention-to-treat and as-treated analyses . Conclusion . For spinal stenosis with neurogenic claudication , decompressive surgery as well as X-Stop are appropriate procedures . Similar results were achieved in both groups , however , with a higher number of reoperations in the X-Stop group . Patients having X-Stop removal and decompression experienced results similar to those r and omized to primary decompression . Level of Evidence : Study Design . R and omized clinical trial with 2-year follow-up . Objective . To compare the cost-effectiveness of X-stop to minimally invasive decompression in patients with symptomatic lumbar spinal stenosis . Summary of Background Data . Lumbar spinal stenosis is the most common indication for operative treatment in elderly . Although surgery is more costly than nonoperative treatment , health outcomes for more than 2 years were shown to be significantly better . Surgical treatment with minimally invasive decompression is widely used . X-stop is introduced as another minimally invasive technique showing good results compared with nonoperative treatment . Methods . We enrolled 96 patients aged 50 to 85 years , with symptoms of neurogenic intermittent claudication within 250-m walking distance and 1- or 2-level lumbar spinal stenosis , r and omized to either minimally invasive decompression or X-stop . Quality -adjusted life-years were based on EuroQol EQ-5D . The hospital unit costs were estimated by means of the top-down approach . Each cost unit was converted into a monetary value by dividing the overall cost by the amount of cost units produced . The analysis of costs and health outcomes is presented by the incremental cost-effectiveness ratio . Results . The study was terminated after a midway interim analysis because of significantly higher reoperation rate in the X-stop group ( 33 % ) . The incremental cost for X-stop compared with minimally invasive decompression was & OV0556;2832 ( 95 % confidence interval : 1886–3778 ) , whereas the incremental health gain was 0.11 quality -adjusted life-year ( 95 % confidence interval : −0.01 to 0.23 ) . Based on the incremental cost and effect , the incremental cost-effectiveness ratio was & OV0556;25,700 . Conclusion . The majority of the bootstrap sample s displayed in the northeast corner of the cost-effectiveness plane , giving a 50 % likelihood that X-stop is cost-effective at the extra cost of & OV0556;25,700 ( incremental cost-effectiveness ratio ) for a quality -adjusted life-year . The significantly higher cost of X-stop is mainly due to implant cost and the significantly higher reoperation rate . Level of Evidence : Purpose Percutaneous interspinous st and -alone spacers offer a simple and effective technique to treat lumbar spinal stenosis with neurogenic claudication . Nonetheless , open decompressive surgery remains the st and ard of care . This study compares the effectiveness of both techniques and the validity of percutaneous interspinous spacer use . Methods Forty-five patients were included in this open prospect i ve non-r and omized study , and treated either with percutaneous interspinous st and -alone spacers ( Aperius ® ) or bilateral open microsurgical decompression at L3/4 or L4/5 . Patient data , operative data , COMI , SF-36 , PCS and MCS , ODI , and walking distance were collected 6 weeks , 3 , 6 , 9 , 12 , and 24 months post-surgery . Results Group 1 ( n = 12 ) underwent spacer implantation , group 2 ( n = 33 ) open decompression . Five patients from group 1 required implant removal and open decompression during follow-up ( FU ) ; one patient was lost to FU . From group 2 , seven patients were lost to FU . Remaining patients were assessed as above . After 2 years , back pain , leg pain , ODI , and quality of life improved significantly for group 2 . Remaining group 1 patients ( n = 6 ) reported worse results . Walking distance improved for both groups . Conclusion Decompression proved superior to percutaneous st and -alone spacer implantation in our two observational cohorts . Therapeutic failure was too high for interspinous spacers Study Design . A r and omized , controlled , prospect i ve multicenter trial comparing the outcomes of neurogenic intermittent claudication ( NIC ) patients treated with the interspinous process decompression system \n Output:\n " }, { "from": "agent", "value": "There was no significant difference in VAS back pain , leg pain or ODI scores for st and alone interspinous process device ( IPD ) vs. bony decompression .\nIPD as an adjunct to decompression had comparable patient-reported scores , complications and reoperation rates to decompression alone .\nCurrent evidence indicates no superiority for mid- to long-term patient-reported outcomes for IPD compared with traditional bony decompression , with lesser surgical complications but at the risk of significantly higher reoperation rates and costs" } ]

[ { "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 Recent reports demonstrated in vitro the efficacy of fluvastatin in inhibiting hepatitis C virus ( HCV ) replication and a synergistic effect in association with interferon-alpha ( IFN-alpha ) . In vivo the inhibition of HCV replication by statins has not been demonstrated . We evaluated in this open-label , r and omized controlled study the efficacy of fluvastatin as adjuvant to pegylated-(PEG)-IFN and ribavirin in HIV/HCV genotype 1 co-infected patients . PATIENTS AND METHODS Forty-four HIV/HCV co-infected patients were r and omized to receive , in addition to PEG-IFN-alpha 2b and ribavirin , 80 mg of fluvastatin once daily or no medication . Primary and secondary endpoints were the achievement of sustained virological response ( SVR ) and rapid virological response ( RVR ) , respectively . RESULTS By intent-to-treat analysis , 25 % of the patients achieved an SVR . An SVR was observed in 8/21 patients in the fluvastatin arm and in 3/23 patients in the st and ard therapy arm ( P = 0.08 ) . A significantly higher RVR rate was obtained in the fluvastatin arm compared with the st and ard therapy [ 7/21 ( 33 % ) and 1/23 ( 4 % ) , respectively ; P = 0.02 ] . Baseline alanine aminotransferase ( ALT ) values and fluvastatin treatment arm were the only predictors of RVR at the univariate analysis ; however , no predictors were independently associated with RVR or SVR at the multivariate analysis . CONCLUSIONS Fluvastatin addition to st and ard therapy did not significantly increase the SVR rate in HIV/HCV genotype 1 co-infected patients ; however , it did significantly improve the RVR . Further studies are needed to confirm these promising results and to investigate the mechanisms of action of statins in HCV infection This pilot aims to better underst and the market for childcare in Saudi Arabia – both the supply and dem and sides – and to design a r and omized controlled experiment to test whether access to affordable day care ( in the form of subsidies , for example ) would incentivize Saudi mothers to search actively for employment and to remain employed once they are hired . In addition , the study seeks to underst and the degree to which employment early on in one ’s life impacts employment in later stages . The pilot will provide information on the groups of women the experiment should target , appropriate levels for the childcare subsidy , and the quality and current geographic locations of daycare sites . Expected Impact Determine the effects of facilitating childcare access on Saudi women ’s employment . PRINCIPAL INVESTIGATORS  Boston University Patricia Cortes  Harvard University Claudia Goldin  Swarthmore College Jennifer Pegylated interferon (PEG-IFN)/ribavirin combination therapy is the st and ard-of-care ( SOC ) treatment for chronic hepatitis C patients infected with hepatitis C virus ( HCV ) genotype 1b and high viral load . The addition of fluvastatin to SOC treatment has been suggested to be effective for better outcome in retrospective pilot analyses . We investigated whether the combination of fluvastatin with PEG-IFN/ribavirin could actually improve sustained viral response ( SVR ) in patients with HCV genotype 1b and high viral load . A r and omized , open-labeled , controlled study was conducted between July 2008 and December 2009 in 101 chronic hepatitis C patients allocated to PEG-IFN/ribavirin combination therapy with or without fluvastatin . SVR rates were calculated in groups , stratifying host and viral factors . We also analyzed predictive factors for SVR among patients on fluvastatin with multivariate regression analysis . Rapid and early virological , and end of treatment response rates in the fluvastatin group were not significantly different from those in the non-fluvastatin group . Notwithst and ing , SVR rate was significantly higher in the fluvastatin group than in the non-fluvastatin group ( 63.0%vs 41.7 % , P = 0.0422 ) . Comparison of the two groups stratifying demographic data and HCV characteristics showed significantly higher SVR rates to more than 80 % in males , more than two mutations in the interferon sensitivity determining region ( ISDR ) , and a history of relapse among the fluvastatin group than the non-fluvastatin group . Being male and major genotype IL28B single nucleotide polymorphisms ( SNPs ) were independent predictive factors for SVR among patients on fluvastatin with multivariate analysis . Fluvastatin-combined with PEG-IFN/ribavirin therapy significantly improves SVR rates in patients with HCV genotype 1b and high viral load . Male and major genotype IL28B SNPs were independent predictors for SVR among patients on fluvastatin combination therapy Cholesterol bio synthesis is an integral part of HCV RNA replication . Not only does HCV RNA replicate on lipid rafts , but it also requires cholesterol intermediates to replicate . In addition , it has been shown in vitro that several HMG‐CoA reductase inhibitors can decrease HCV RNA replication by ≥ 1 log . Therefore , we design ed a clinical trial to evaluate the effect of atorvastatin on HCV RNA levels . In this prospect i ve clinical trial , where patients served as their own control , 10 HCV‐infected patients who required treatment for high cholesterol were given 20 mg atorvastatin per day . Although serum cholesterol and LDL predictably decreased significantly , there was no statistically significant change in week 4 and week 12 HCV RNA levels compared to pretreatment HCV RNA levels by the paired Student t test . It is unclear whether the addition of an HMG‐CoA reductase inhibitor to interferon or a more potent inhibitor of cholesterol bio synthesis may be required to inhibit HCV RNA replication in vivo . In conclusion , atorvastatin , and likely all HMG‐CoA reductase inhibitors , does not inhibit HCV RNA replication in vivo at conventional doses . ( HEPATOLOGY 2007;45:895–898 . Background Nonalcoholic fatty liver disease develops in patients with chronic hepatitis C. Interferon and ribavirin combination therapy is the st and ard treatment for chronic hepatitis C , but if present , NAFLD can reduce the virological response to anti-HCV therapies . Objectives We determined whether the addition of rosuvastatin to interferon and ribavirin improves the sustained virological response ( SVR ) and reduces steatosis . Patients and Methods This study was a prospect i ve , r and omized , open-label trial . Between January 2004 and December 2007 , 65 patients with chronic hepatitis ( 27 women and 38 men , mean age 48 years ) aged 32 - 63 years ( median 46 years ) were consecutively enrolled . Patients were r and omly assigned to receive leukocyte interferon alpha ( 3 MIU 3 times per week ) plus ribavirin ( 1200 mg per day ) for 12 months or interferon alpha and ribavirin at the same dosages plus rosuvastatin ( 5 mg per day ) . The primary endpoints were measurements in SVR , liver enzyme , cholesterol , triglyceride , CRP , glucose , and insulin levels ; and Homa-IR , fibrosis , and steatosis scores . Results After 12 months of treatment , we observed a significant improvement in SVR in 51 % of patients who received interferon plus ribavirin plus rosuvastatin compared with 18 % of relapsers ( OR 1.52 ; 95 % CI = 0.41 - 5.64 ; RR 1.13 ) . There were 23 responders ( 69 % ) and 10 nonresponders ( 30 % ) ( OR 1.38 ; 95 % CI = 0.49 - 16.5 ; RR 1.11 ) . When comparing interferon plus ribavirin group vs interferon plus ribavirin and rosuvastatin group after 12 months , we observed a significant difference in AST ( 85.70 vs.106.5.00 IU/ml ) ( OR 1.2 ; 95 % CI= 0.29 - 4.94 ; RR 1.04 ; p<0.001 ) , ALT ( 81.80 vs. 126.2 IU/ml ) ( OR 1.2 ; 95 % CI = 0.29 - 4.94 ; RR 1.04 ; p < 0.001 ) , LDL-cholesterol ( 0.01 vs. 0.60 mmol/l ) ( OR 14 ; 95 % CI = 3.98 - 49.16 ; p RR 2.96 ; < 0.001 ) , triglycerides ( 0.17 vs. 0.2 mmol/l ) ( OR 20 ; 95 % CI = 4.94 - 80.89 ; RR 5.38 ; p < 0.05 ) , and Viremia ( 1.8 vs. 2.48 UI/ml , p < 0.05 ) . Mean fibrosis score decreased 0.10 vs. 0.50 ( OR 4.5 ; 95 % CI = 0.89 - 22.66 ; RR 1.5 ; p < 0.05 ) , and mean steatosis score declined 0.30 vs. 0.50 ( OR 11.2 ; CI = 2.88 - 43.53 ; RR 2.75 ; p < 0.001 ) . Conclusions In HCV patients with NAFLD , the addition of rosuvastatin to interferon and ribavirin significantly reduces viremia , steatosis , and fibrosis without causing side effects BACKGROUND Hepatitis C viral ( HCV ) infection is the leading cause of death due to liver disease in the United States . Currently , pegylated interferon and ribavirin produce sustained viral remission in only 50 % of patients . Additional agents are needed to increase the cure rate . In vitro experiments show strong antiviral effects of fluvastatin against HCV . OBJECTIVES : To assess the safety and antiviral effects of fluvastatin in chronic HCV carriers . METHODS : 31 veterans with chronic HCV were prospect ively given oral doses of fluvastatin , 20 to 320 mg/day , for 2–12 weeks with weekly monitoring of HCV RNA and liver tests . Reductions of viral load ( P < 0.01 ) versus a control group were considered suppressive . RESULTS : With 80 mg a day or less , 11/22 ( 50 % ) patients responded by lowering HCV RNA . The first lowering occurred within 4 weeks ( 9/11 , 82 % ) . The greatest weekly change in HCV RNA level was a 1.75 log10 reduction . When lowered in responders , the viral load remained relatively constant for 2–5 weeks ( 7/9 , 78 % ) , or on the next test rebounded immediately to a non-significant change from , baseline ( n = 2 ) . Continued lowering of virus was seen in 2/19 ( 22 % ) patients when the study ended . We found no evidence of liver tests worsening . CONCLUSIONS : FLV used as monotherapy in vivo showed suppressive effects of HCV clinical ly that are modest , variable , and often short-lived . These findings support “ proof-of-concept ” for pilot trials combining fluvastatin with st and ard therapy . Statins and fluvastatin , in particular , appear to be safe for use in hepatitis Fluvastatin showed anti-hepatitis C virus ( HCV ) activity in vitro , through the inhibition of geranylgeranylation of cellular proteins , and a synergistic effect with interferon (IFN)-alpha . Nevertheless statins up-regulate low-density lipoprotein ( LDL ) receptor , required for HCV cell entry , and the closely related scavenger receptors SRBI and CD36 ; moreover they reduce class II major histocompatibility complex expression on antigen presenting cell , modulating T-cell activation . In vivo LDL levels have been identified as prognostic indicator of sustained viral response to IFN in patients with HCV infection , suggesting that lipid-lowering agents might conversely favour HCV entry into the hepatocytes and translate into higher viral replication . We evaluated the effect of fluvastatin on HCV-RNA levels , CD36 expression and T-cell homeostasis in HCV-RNA positive patients . HCV-RNA was measured at baseline and after 4 weeks in 42 HCV/HIV-1 co-infected patients , r and omized to receive either fluvastatin 80 mg qd or no treatment . CD36 expression and markers of T-cell activation were evaluated by means of flow cytometry . Plasma interleukin (IL)-10 , IFN-gamma and IL-7 were measured by ELISA . Serum cholesterol and LDL decreased significantly in the treatment group ( P = 0.0001 and 0.01 , respectively ) . Surprisingly a significant increase of HCV-RNA levels was seen after 4 weeks of fluvastatin ( P = 0.03 ) . The percentages of naive/activated/ \n Output:\n " }, { "from": "agent", "value": "There were no significant increases in adverse events and withdrawals with the addition of statins ." } ]

[ { "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 diagnostic accuracy of otitis media with effusion ( OME ) has been shown to be poor among medical students , residents , and practicing physicians . OBJECTIVE to determine if the use of pneumatic video-otoendoscopic examination ( VOE ) improves the diagnostic accuracy of OME among residents . METHODS pediatric residents were r and omized into a \" pneumatic \" examination group ( intervention ) and a \" still \" examination group ( control ) . The control group viewed a set of 25 still VOE images of the tympanic membranes of both normal and OME ears . The intervention group viewed the same still images but with the addition of pneumatic VOE assessment s. Each resident documented each of his or her diagnoses as normal or OME . The accuracy of assessment for both the static and the pneumatic methods was compared . RESULTS twenty-nine pediatric residents participated in this study : 15 in the intervention group and 14 in the control group . The overall diagnostic accuracy was 91 % for the intervention group versus 78 % for the control group ( p = .0003 ) . CONCLUSION pneumatic video-otoscopy teaching improves the diagnostic accuracy of OME among residents Background Recently , medical education in surgery has experienced several modifications . We have implemented a blended learning module in our teaching curriculum to evaluate its effectiveness , applicability , and acceptance in surgical education . Methods In this prospect i ve study , the traditional face-to-face learning of our teaching curriculum for fourth-year medical students ( n = 116 ) was augmented by the Inmedea Simulator , a web-based E-learning system , with six virtual patient cases . Student results were documented by the system and learning success was determined by comparing patient cases with comparable diseases ( second and sixth case ) . The acceptance among the students was evaluated with a question naire . Results After using the Inmedea Simulator , correct diagnoses were found significantly ( P < 0.05 ) more often , while an incomplete diagnostic was seen significantly ( P < 0.05 ) less often . Significant overall improvement ( P < 0.05 ) was seen in sixth case ( 62.3 ± 5.6 % ) vs. second case ( 53.9 ± 5.6 % ) . The question naire revealed that our students enjoyed the surgical seminar ( score 2.1 ± 1.5 ) and preferred blended learning ( score 2.5 ± 1.2 ) to conventional teaching . Conclusion The blended learning approach using the Inmedea Simulator was highly appreciated by our medical students and result ed in a significant learning success . Blended learning appears to be a suitable tool to complement traditional teaching in surgery Introduction Video teaching modules are proven effective tools for enhancing student competencies and technical skills in the operating room . Integration into post-graduate surgical curricula , however , continues to pose a challenge in modern surgical education . To date , video teaching modules for neck dissection have yet to be described in the literature . Purpose To develop and vali date an HD video-based teaching module ( HDVM ) to help instruct post-graduate otolaryngology trainees in performing neck dissection . Methods This prospect i ve study included 6 intermediate to senior otolaryngology residents . All consented subjects first performed a control selective neck dissection . Subjects were then exposed to the video teaching module . Following a washout period , a repeat procedure was performed . Recordings of the both sets of neck dissections were de-identified and review ed by an independent evaluator and scored using the Observational Clinical Human Reliability Assessment ( OCHRA ) system . Results In total 91 surgical errors were made prior to the HDVM and 41 after exposure , representing a 55 % decrease in error occurrence . The two groups were found to be significantly different . Similarly , 66 and 24 staff takeover events occurred pre and post HDVM exposure , respectively , representing a statistically significant 64 % decrease . Conclusion HDVM is a useful adjunct to classical surgical training . Residents performed significantly less errors following exposure to the HD-video module . Similarly , significantly less staff takeover events occurred following exposure to the HDVM OBJECTIVE To evaluate students ' overall assessment and effectiveness of the web-based blended learning conception \" Unified Patient Project \" ( UPP ) for medical students rotating on their otolaryngology internship ( ear , nose , and throat [ ENT ] tertiary ) . DESIGN Prospect i ve comparison group design of the quasiexperimental type . SETTING Medical education . SUBJECTS The experimental group ( preintervention test [ pretest ] , intervention , and postintervention test [ posttest ] ) comprised 117 students , and the comparison group ( pretest , alternative intervention , and posttest ) , 119 . INTERVENTIONS In the experimental group , lecturing of case studies was replaced by the blended learning concept UPP . A st and ardized question naire evaluated students ' overall assessment of teaching otolaryngology . A pretest and posttest using multiple choice questions was administered to clarify whether the UPP has led to a knowledge gain . RESULTS The comparison group was more satisfied with their teaching ; however , this was not statistically significant ( P = .26 ) compared with the UPP . Students with higher preknowledge benefitted from the UPP , while students with lower preknowledge did not ( P = .01 ) . On average , posttest results in the experimental group exceeded those of the comparison group by 8.7 percentage points for a 75 % preknowledge of the maximum attainable score , while they fell below those of the comparison group by 8.1 percentage points for a 25 % preknowledge . CONCLUSIONS Students ' satisfaction with the blended learning concept UPP was lower than in the face-to-face teaching , although this was not statistically significant . The new web-based UPP leads to an improved knowledge in clinical otolaryngology for all students . Students with lower preknowledge benefitted more from face-to-face teaching than from the UPP , while students with higher preknowledge benefitted more from the UPP . This implies students with poor preknowledge need special promotion programs INTRODUCTION The use of computer-generated 3-dimensional ( 3-D ) anatomical models to teach anatomy has proliferated . However , there is little evidence that these models are educationally effective . The purpose of this study was to test the educational effectiveness of a computer-generated 3-D model of the middle and inner ear . METHODS We reconstructed a fully interactive model of the middle and inner ear from a magnetic resonance imaging scan of a human cadaver ear . To test the model 's educational usefulness , we conducted a r and omised controlled study in which 28 medical students completed a Web-based tutorial on ear anatomy that included the interactive model , while a control group of 29 students took the tutorial without exposure to the model . At the end of the tutorials , both groups were asked a series of 15 quiz questions to evaluate their knowledge of 3-D relationships within the ear . RESULTS The intervention group 's mean score on the quiz was 83 % , while that of the control group was 65 % . This difference in means was highly significant ( P < 0.001 ) . DISCUSSION Our findings st and in contrast to the h and ful of previous r and omised controlled trials that evaluated the effects of computer-generated 3-D anatomical models on learning . The equivocal and negative results of these previous studies may be due to the limitations of these studies ( such as small sample size ) as well as the limitations of the models that were studied ( such as a lack of full interactivity ) . Given our positive results , we believe that further research is warranted concerning the educational effectiveness of computer-generated anatomical models BACKGROUND Mannequin and computer-based simulators are useful for the practice of patient management , physical procedures , and competency . However , they are ineffective in teaching clinical medicine . StepStone Interactive Medical Software ( SS ) is a web-based medical learning modality that provides the user with a highly focused set of evaluative and interventional tasks to treat memorable virtual patients in a visual case-based format . OBJECTIVE To determine whether the SS learning modality is superior to traditional lecture format in medical student learning and retention . METHODS After Institutional Review Board ( IRB ) approval was obtained and the consents were signed , 30 third-year medical students were assigned r and omly to 2 groups of 15 students each : The control group received two 30-minute PowerPoint lectures ( Microsoft Corporation , Redmond , Washington ) about torsades de pointes ( TdP ) and pulseless electrical activity ( PEA ) , and the SS group was given 1 hour to review 2 SS cases teaching TdP and PEA . A preintervention test was given to assess their baseline knowledge . An immediate postintervention test was given to both groups . Twenty-two days later , a long-term retention test was administered . The results were analyzed using a Student t test for continuous variables . RESULTS The mean scores for the preintervention test in the control and SS groups were 44.9 ± 3 % and 44.1 ± 2 % , respectively ( p = 0.41 ) . The mean scores for the postintervention test in the control and SS groups were 61.7 ± 2 % and 86.7 ± 2 % , respectively ( p < 0.001 ) . Improvement from baseline knowledge was calculated , and the mean improvement was 16.8 ± 3 % in the control group and 42.5 ± 2 % in the SS group ( p < 0.001 ) . The long-term retention test revealed the mean scores of 55.8 ± 3 % in the control group and 70.1 ± 3 % in the SS group ( p < 0.001 ) . Long-term improvement from baseline knowledge was calculated and the control group improved by 10.9 ± 4 % , whereas the SS group improved by 26 ± 3 % ( p = 0.002 ) . CONCLUSIONS The SS learning modality demonstrated a significant improvement in student learning retention compared to traditional didactic lecture format . SS is an effective web-based medical education tool Introduction : Plastic surgery training has traditionally been modeled as an “ apprenticeship , ” where faculty teach surgical skills to residents on live patients . Although this is a well-established process , the dem and by the public and healthcare agencies for improved patient care , outcomes , and patient safety has led to the development of adjunct methods of teaching . The goal of this project is to assess the effectiveness of a web-based microsurgical curriculum . Methods : We developed an interactive Web site to teach essential microsurgical competencies . Residents were r and omly divided into 2 cohorts : one experimental group completed this online re source and the other control group did not . Pre- and post assessment s were administered , consisting of a written test and a recorded microsurgery skills session . Results : A total of 17 plastic surgery residents of various training levels participated in the study . Residents who completed the web-based curriculum showed dramatic improvement in their knowledge and skills , with a 17-percentage point increase in their test scores ( P = 0.01 ) compared with controls ( P = 0.80 ) . The experimental group was more likely to perform microanastomoses faster with an average of 4.5-minute improvement compared with 1.25-minute change among the control group . Residents performed self- assessment s , and those who rated themselves as “ very confident ” had higher overall test scores ( 85 % test score vs. 59 % , P = 0.004 ) , as well as shorter times to complete the microsurgical task ( 7.5 minutes vs. 13.6 minutes , P = 0.007 ) . Overall , 62 % of residents rated the online webpage as extremely valuable . The majority of residents reported the webpage improved their knowledge and markedly improved their microsurgical technique , which was confirmed by faculty experts . Conclusions : Our interactive Web-based curriculum is a novel re source , teaching microsurgery in an organized , competency-based manner , which we believe is the first Web site of this nature . An individualized , self-paced Web site is ideal for plastic surgery trainees of all levels . Overall , the widespread implementation of our proposed curriculum — online self-directed training combined with regular practice sessions — will establish a strong foundation of microsurgery knowledge and skills acquisition for all plastic surgery residents OBJECTIVES To establish discriminant validity of the endoscopic sinus surgery simulator ( ES3 ) ( Lockheed Martin , Akron , Ohio ) between various health care provider experience levels and to define benchmarking criteria for skills assessment . DESIGN Prospect i ve multi-institutional comparison study . SETTING University-based tertiary care institution . PARTICIPANTS Ten expert otolaryngologists , 14 otolaryngology residents , and 10 medical students . INTERVENTIONS Subjects completed the ES3 's virtual reality curriculum ( 10 novice mode , 10 intermediate mode , and 3 advanced mode trials ) . Performance scores were recorded on each trial . Performance differences were analyzed using analysis of variance for repeated measures ( experience level as between-subjects factor ) . MAIN OUTCOME MEASURES Simulator performance scores , accuracy , time to completion , and hazard disruption . RESULTS The novice mode accurately distinguished the 3 groups , particularly at the onset of training ( mean scores : senior otolaryngologists , 66.0 ; residents , 42.7 ; students , 18.3 ; for the paired comparisons between groups 1 and 2 and groups 1 and 3 , P = .04 and .03 , respectively ) . Subjects were not distinguished beyond trial 5 . The intermediate mode only discriminated students from other subjects ( P = .008 ) . The advanced mode did not show performance differences between groups . Scores on the novice mode predicted those on the intermediate mode , which predicted advanced mode scores ( r = 0.687 ) , but no relationship was found between novice and advanced scores . All groups performed equally well and with comparable consistency at the outset of training . Expert scores were used to define benchmark criteria of optimal performance . CONCLUSIONS This study completes the construct validity assessment of the ES3 by demonstrating its discriminant capabilities . It establishes expert surgeon benchmark performance criteria and shows that the ES3 can train novice subjects to attain those . The refined analysis of trial performance scores could serve educational and skills assessment purpose s. Current studies are evaluating the transfer of surgical skills acquired on the ES3 to the \n Output:\n " }, { "from": "agent", "value": "E-learning proves to be a powerful alternative to st and ard teaching techniques within otolaryngology education for both residents and medical students ." } ]

[ { "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: 200 adult respiratory distress syndrome patients were included in a prospect i ve multicenter r and omized trial to determine the efficacy of computerized decision support . The study was done in 10 medical centers across the United States . There was no significant difference in survival between the two treatment groups ( mean 2 = 0.49 p = 0.49 ) or in ICU length of stay between the two treatment groups when controlling for survival ( F(1df ) = 0.88 , p = 0.37 . ) There was a significant reduction in morbidity as measured by multi-organ dysfunction score in the protocol group ( F(1df ) = 4.1 , p = 0.04 ) as well as significantly lower incidence and severity of overdistension lung injury ( F(1df ) = 45.2 , p < 0.001 ) . We rejected the null hypothesis . Efficacy was best for the protocol group . Protocol s were used for 32,055 hours ( 15 staff person years , 3.7 patient years or 1335 patient days ) . Protocol s were active 96 % of the time . 38,546 instructions were generated . 94 % were followed . This study indicates that care using a computerized decision support system for ventilator management can be effectively transferred to many different clinical setting s and significantly improve patient morbidity We developed a computer-stored medical record system containing a limited set of the total clinical data base -- primarily diagnostic studies and treatments . This system responds to its own content according to physician-authored reminder rules . To determine the effect of the reminder messages generated by 1490 rules on physician behavior , we r and omly assigned practitioners in a general medicine clinic to study or control groups . The computer found indications for six different actions per patient in 12 467 patients during a 2-year study : 61 study group residents who received computer reminders responded to 49 % of these indications ; 54 control group residents , to only 29 % ( p less than 0.0001 ) . Preventive care ( occult blood testing , mammographic screening , weight reduction diets , influenza and pneumococcal vaccines ) was affected . The intentions of the study group to use a given action for an indication predicted their response to the indications ( p less than 0.03 , r2 = 0.33 ) . The intentions of the control residents did not Three dosage-prediction methods for initial in-hospital stabilization of warfarin therapy were evaluated . Adult in patients who had received warfarin sodium 10 mg daily for less than three days were eligible for the study . After receiving their third warfarin dose , patients were r and omly assigned to have their warfarin dosages adjusted using one of three dosage-prediction methods : by analog computer ( n = 31 ) , linear regression ( n = 22 ) , or empiric dosing by the physician ( n = 34 ) . A prothrombin time ( PT ) ratio ( patient PT divided by control PT ) between 1.3 and 2.5 was considered to be in the therapeutic range . For patients who achieved a stable PT ratio ( defined as a PT ratio between 1.3 and 2.5 that varied by less than 0.05 on two consecutive days or by less than 0.1 on three consecutive days without a dosage change ) before discharge , the number of days ( time to stabilization ) from administration of the first warfarin dose to achievement of the warfarin dosage that produced a stable PT ratio ( stabilization dosage ) was compared . A total of 54 patients met the study criteria for a stable PT ratio before hospital discharge ( analog computer , n = 20 ; linear regression , n = 15 ; empiric dosing , n = 19 ) . The mean times to stabilization were 6.8 days in the analog-computer group , 7.3 days in the linear-regression group , and 8.4 days in the empiric-dosing group ; these times were not significantly different . All 20 stabilized patients in the analog-computer group achieved a stable PT ratio by the fourth dosage prediction . ( ABSTRACT TRUNCATED AT 250 WORDS OBJECTIVE To compare effects on premature infants ' weight gain of a computer-generated and a nurse-determined incubator humidity strategy . An optimal humidity protocol is thought to reduce time to regain birthweight . DESIGN Prospect i ve r and omized controlled design . SETTING Level IIIC neonatal intensive care unit in the Netherl and s. PARTICIPANTS Infants of 24 to 30 weeks gestational age with a birthweight less than 1,500 g. INTERVENTION Two incubator humidity strategies were studied : computer-generated and nurse-determined humidity . MAIN OUTCOME MEASURE Time needed to regain birthweight . RESULTS One hundred thirty six infants were enrolled : 65 were exposed to the computer-generated strategy and 71 to the nurse-determined strategy . Demographic characteristics were well balanced between groups , with birthweight 981 + /- 245 versus 991 + /- 213 g , mean gestational age 27.7 + /- 1.7 versus 27.7 + /- 1.6 weeks . Main outcome did not significantly differ between strategies : survival analysis showed an equal number of days needed to regain birthweight ( median 9 days , with 95 % CIs 8 - 10 and 7 - 11 for infants exposed to the computer-generated and nurse-determined humidity strategy , respectively ) . CONCLUSION Computer-generated strategy does not reduce the time needed to regain birthweight Guided dosing within a computerized provider order entry ( CPOE ) system is an effective method of individualizing therapy for patients . Physicians ' responses to guided dosing decision support have not been extensively studied . As part of a r and omized trial evaluating efficacy of dosing advice on reducing falls in the elderly , CPOE prompts to physicians for 88 drugs included tailored messages and guided dose lists with recommended initial doses and frequencies . The study captured all prescribing activity electronically . The primary outcome was the ratio between prescribed dose and recommended dose . Over 9 months , 778 providers entered 9111 study -related medication orders on 2981 patients . Physicians using guided orders chose recommended doses more often than controls(28.6 % vs. 24.1 % , p<0.001 ) . Selected doses were significantly lower in the intervention group ( median ratio of actual to recommended 2.5 , interquartile range [ 1.0,4.0 ] ) than the control group ( median 3.0 interquartile range [ 1.5,5.0 ] , p<0.001 ) . While physicians selected the recommended dose less than a third of the time , guided geriatric dosing modestly improved compliance with guidelines Background : To investigate whether intensive treatment with methotrexate ( MTX ) according to a strict protocol and a computerised decision program is more beneficial compared to conventional treatment with MTX in early rheumatoid arthritis . Methods : In a two-year multicentre open label strategy trial , 299 patients with early rheumatoid arthritis were r and omly assigned to the intensive strategy group or the conventional strategy group . Patients in both groups received MTX , the aim of treatment being remission . Patients in the intensive treatment group came to the outpatient clinic once every month ; adjustment of the MTX dosage was tailored to the individual patient on the basis of predefined response criteria , using a computerised decision program . Patients of the conventional strategy group came to the outpatient clinic once every three months ; they were treated according to common practice . Cyclosporine was added if patients had an inadequate response to maximal tolerated MTX doses . Results : Seventy six ( 50 % ) patients in the intensive strategy group achieved at least one period of remission during the two year trial , versus 55 patients ( 37 % ) in the conventional strategy group ( p = 0.03 ) . Areas under the curve for nearly all clinical variables were significantly lower — that is , there was a better clinical effect for the intensive treatment group compared with the conventional treatment group . Conclusion : The results of this study show that it is possible to substantially enhance the clinical efficacy early in the course of the disease by intensifying treatment with MTX , aim ing for remission , tailored to the individual patient . Furthermore , participating rheumatologists indicated that the computerised decision program could be a helpful tool in their daily clinical practice This study was undertaken to determine if a computerized pharmacokinetic program for adjusting theophylline infusion rates could attain a goal serum theophylline level more accurately than physician‐derived adjustments and what clinical impact this would have . Thirty‐five patients with diagnoses of asthma or chronic obstructive pulmonary disease were r and omized to a control group ( empiric ) or experimental group ( kinetic ) after initial theophylline levels were drawn from each group . After second levels were drawn , patients in the kinetic group had their infusion rates adjusted by the computerized pharmacokinetic program to achieve a level of 15 mg/L , whereas patients in the empiric group had their infusions adjusted empirically by the primary care physicians to achieve a serum theophylline level of 15 mg/L. A final theophylline level was obtained just before the infusion was discontinued . The kinetic group was closer to the goal level of 15 mg/L than the empiric group , but this was not statistically significant ( 14.8 ± 4.4 versus 12.6 ± 4.1 ; p > 0.05 ) . The total number of days that patients were receiving intravenous theophylline was slightly longer for the kinetic group ( 4.1 ± 3.3 versus 3.2 ± 1.5 ; p > 0.05 ) as was the total number of hospital days , but neither of these were statistically significant ( 11.4 ± 21.6 versus 8.8 ± 15.4 days ; p > 0.05 ) . There were no differences between the two groups in the number of subtherapeutic or toxic levels , and there were no significant differences in arterial blood gas measurements . We were unable to show in this study any clinical advantage to adjusting the dosage of a theophylline infusion by a computerized pharmacokinetic program compared with adjustments made empirically by a physician OBJECTIVE To assess the impact of an automated intraoperative alert to redose prophylactic antibiotics in prolonged cardiac operations . DESIGN R and omized , controlled , evaluator-blinded trial . SETTING University-affiliated hospital . PATIENTS Patients undergoing cardiac surgery that lasted more than 4 hours after the preoperative administration of cefazolin , unless they were receiving therapeutic antibiotics at the time of surgery . INTERVENTION R and omization to an audible and visual reminder on the operating room computer console at 225 minutes after the administration of preoperative antibiotics ( reminder group , n = 137 ) or control ( n = 136 ) . After another 30 minutes , the circulating nurse was required to indicate whether a follow-up dose of antibiotics had been administered . RESULTS Intraoperative redosing was significantly more frequent in the reminder group ( 93 of 137 ; 68 % ) than in the control group ( 55 of 136 ; 40 % ) ( adjusted odds ratio , 3.31 ; 95 % confidence interval , 1.97 to 5.56 ; P < .0001 ) . The impact of the reminder was even greater when compared with the 6 months preceding the study period ( 129 of 480 ; 27 % ; P < .001 ) , suggesting some spillover effect on the control group . Redosing was formally declined for 19 of the 44 patients in the reminder group without redosing . The rate of surgical-site infection in the reminder group ( 5 of 137 ; 4 % ) was similar to that in the control group ( 8 of 136 ; 6 % ; P = .42 ) , but significantly lower than that in the pre- study period ( 48 of 480 ; 10 % ; P = .02 ) . CONCLUSION The use of an automatic reminder system in the operating room improved compliance with guidelines on perioperative antibiotic prophylaxis OBJECTIVES To evaluate the effectiveness of computer-assisted decision support in reducing potentially inappropriate prescribing to older adults . DESIGN R and omized , controlled trial . SETTING An academic emergency department ( ED ) in Indianapolis , Indiana , where computerized physician order entry was used to write all medication prescriptions . PARTICIPANTS Sixty-three emergency physicians were r and omized to the intervention ( 32 physicians ) or control ( 31 physicians ) group . INTERVENTION Decision support that advised against use of nine potentially inappropriate medications and recommended safer substitute therapies . MEASUREMENTS The primary outcome was the proportion of ED visits by seniors that result ed in one or more prescriptions for an inappropriate medication . The main secondary outcomes were the proportions of medications prescribed that were inappropriate and intervention physicians ' reasons for rejecting the decision support . RESULTS The average age of the patients was 74 , two-thirds were female , and just over half were African American . Decision support was provided 114 times to intervention physicians , who accepted 49 ( 43 % ) of the recommendations . Intervention physicians prescribed one or more inappropriate medications during 2.6 % of ED visits by seniors , compared with 3.9 % of visits managed by control physicians ( P=.02 ; odds ratio=0.55 , 95 % confidence interval=0.34 - 0.89 ) . The proportion of all prescribed medications that were inappropriate significantly decreased from 5.4 % to 3.4 % . The most common reason for rejecting decision support was that the patient had no prior problems with the medic \n Output:\n " }, { "from": "agent", "value": "Conclusion The majority of CCDSSs demonstrated improvements in process of care , but patient outcomes were less likely to be evaluated and far less likely to show positive 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: Objective To investigate the adrenocortical function in brain-dead patients , potential organ donors . Design Prospect i ve study . Setting Intensive care units in two teaching hospitals . Patients A total of 37 patients ( 28 men , nine women ) with severe brain injury , having a mean age of 42 ± 18 yrs , were included in the study . Group A consisted of 20 brain-injured patients who did not deteriorate to brain death . Group B included 17 brain-injured patients who were brain dead ; of these , ten patients developed brain death during ICU stay and seven patients were admitted to the ICU after clinical brain death . Interventions In all patients ( group A and group B ) , a morning blood sample was obtained at admission to the ICU to determine baseline plasma cortisol . Subsequently , 1 & mgr;g of corticotropin ( adrenocorticotropic hormone , Synacthen ) was administered intravenously , and a blood sample was taken 30 mins after the injection . In group B patients who became brain dead while being treated in the ICU ( n = 10 ) , the same procedure was repeated the morning after the confirmation of brain death . Patients having a cortisol level of at least 18 & mgr;g/dL after the administration of adrenocorticotropic hormone were defined as responders . Measurements and Main Results After the occurrence of brain death , group B patients had significantly lower values for baseline ( 8.5 ± 6.2 vs. 17.0 ± 6.6 & mgr;g/dL , p < .001 ) and stimulated ( 16.9 ± 6.3 vs. 23.9 ± 5.7 & mgr;g/dL , p = .001 ) plasma cortisol compared with group A patients . Thirteen group B patients ( 76 % ) and two group A patients ( 10 % ) were nonresponders to adrenocorticotropic hormone ( p < .001 ) . In group B patients , baseline and stimulated cortisol concentrations were significantly related ( r = .71 , p = .001 ) , whereas there was no correlation between baseline cortisol and the increment in cortisol ( r = −.37 , p = .15 ) . Mean hormonal data of the ten brain-dead patients studied at admission in the ICU and after the occurrence of brain death were the following : baseline plasma cortisol ( 23.5 ± 11.4 vs. 6.8 ± 4.2 & mgr;g/dL , p = .003 ) and stimulated serum cortisol ( 28.8 ± 9.9 vs. 16.3 ± 4.3 & mgr;g/dL , p = .008 ) . Conclusions Adrenal cortisol secretion after dynamic stimulation is deficient in a substantial proportion of brain-dead potential organ donors 34 cadaveric donor grafts were r and omized in a blind study of the effect of pretreatment of 5 g each of methylprednisolone and cyclophosphamide on kidney graft outcome . There was no difference in overall survival or functioning after 3 , 6 or 12 months between grafts from pretreated ( 33 kidneys ) or control ( 29 kidneys ) cadaveric donors . In addition , this pretreatment protocol did not modify the recipient immune response against B-lymphocyte alloantigens which developed in unsuccessful transplants . Our data , thus , neither confirm the high rate of kidney graft survival attributed to cadaveric donor treatment nor the supposition that treatment is effective in suppressing recipient antidonor B-lymphocyte antibodies BACKGROUND Posttransplantation acute renal failure ( ARF ) occurs in roughly 25 % of recipients of organs from deceased donors . Inflammation in the donor organ is associated with risk for ARF . OBJECTIVE To determine whether administering corticosteroids to deceased organ donors reduces the incidence and duration of ARF in organ recipients more than placebo . DESIGN Parallel , blocked r and omized trial , performed between February 2006 and November 2008 , with computer-generated r and omization and central ized allocation . Investigators were masked to group assignment . ( Controlled-trials.com registration number : IS RCT N78828338 ) SETTING : 3 renal transplantation centers in Austria and Hungary . PATIENTS 306 deceased heart-beating donors and 455 renal transplant recipients . INTERVENTIONS Organ donors were administered an intravenous infusion of either 1000 mg of methylprednisolone ( 136 donors ) or placebo ( 0.9 % saline ) ( 133 donors ) at least 3 hours before organ harvesting . MEASUREMENTS Incidence of ARF , defined as more than 1 dialysis session in the first week after transplantation , was the primary end point . Secondary and other end points included duration of ARF and trajectories of serum creatinine level . The suppression of immune response and inflammation by the intervention was assessed in the donor organ on a genome-wide basis . RESULTS 52 of 238 recipients ( 22 % ) of kidneys from steroid-treated donors and 54 of 217 recipients ( 25 % ) of kidneys from placebo-treated donors had ARF ( difference , 3 percentage points [ 95 % CI , -11 to 5 percentage points ] ) . One graft was lost on day 1 in each group , and 1 recipient in the placebo group died of cardiac arrest on day 2 . The median duration of ARF was 5 days ( interquartile range , 2 days ) in the steroid group and 4 days ( interquartile range , 2 days ) in the placebo group ( P = 0.31 ) . The groups had similar trajectories of serum creatinine level in the first week ( P = 0.72 ) . Genomic analysis showed suppressed inflammation and immune response in kidney biopsies from deceased donors who received corticosteroids . LIMITATION Donors and recipients were mainly white , and all were from 3 transplantation centers in central Europe , which may limit generalizability . CONCLUSION Systemic suppression of inflammation in deceased donors by corticosteroids did not reduce the incidence or duration of posttransplantation ARF in allograft recipients . PRIMARY FUNDING SOURCE Austrian Science Fund and Austrian Academy of Science OBJECTIVE To test the reliability and validity of specific instructions to classify blinding , when unclearly reported in r and omized trials , as \" probably done \" or \" probably not done . \" STUDY DESIGN AND SETTING We assessed blinding of patients , health care providers , data collectors , outcome adjudicators , and data analysts in 233 r and omized trials in duplicate and independently using detailed instructions . The response options were \" definitely yes , \" \" probably yes , \" \" probably no , \" and \" definitely no. \" We contacted authors for data verification ( 46 % response ) . For each of the five questions , we assessed reliability by calculating the agreement between the two review ers and validity by calculating the agreement between review ers ' consensus and verified data . RESULTS The percentage with unclear blinding status varied between 48.5 % ( patients ) and 84.1 % ( data analysts ) . Reliability was moderate for blinding of outcome adjudicators ( κ=0.52 ) and data analysts ( κ=0.42 ) and substantial for blinding of patients ( κ=0.71 ) , providers ( κ=0.68 ) , and data collectors ( κ=0.65 ) . The raw agreement between the consensus record and the author-verified record varied from 84.1 % ( blinding of data analysts ) to 100 % ( blinding of health care providers ) . CONCLUSION With the possible exception of blinding of data analysts , use of \" probably yes \" and \" probably no \" instead of \" unclear \" may enhance the assessment of blinding in trials AIMS The aim of this study was to assess the haemodynamic effects of tri-iodothyronine ( T3 ) and methylprednisolone in potential heart donors . METHODS AND RESULTS In a prospect i ve r and omized double-blind trial , 80 potential cardiac donors were allocated to receive T3 ( 0.8 microg kg(-1 ) bolus ; 0.113 microg kg(-1 ) h(-1 ) infusion ) ( n = 20 ) , methylprednisolone ( 1000 mg bolus ) ( n = 19 ) , both drugs ( n = 20 ) , or placebo ( n = 21 ) following initial haemodynamic assessment . After hormone or placebo administration , cardiac output-guided optimization was initiated , using vasopressin as a pressor and weaning norepinephrine and inotropes . Treatment was administered for 5.9 + /- 1.3 h until retrieval or end- assessment . Cardiac index increased significantly ( P < 0.001 ) but administration of T3 and methylprednisolone alone or in combination did not affect this change or the heart retrieval rate . Thirty-five per cent ( 14/40 ) of initially marginal or dysfunctional hearts were suitable for transplant at end- assessment . At end- assessment , 50 % of donor hearts fulfilled criteria for transplant suitability . CONCLUSION Cardiac output-directed donor optimization improves donor circulatory status and has potential to increase the retrieval rate of donor hearts . Tri-iodothyronine and methylprednisolone therapy do not appear to acutely affect cardiovascular function or yield 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 Introduction Circulatory failure during brain death organ donor resuscitation is a problem that compromises recovery of organs . Combined administration of steroid , thyroxine and vasopressin has been proposed to optimize the management of brain deceased donors before recovery of organs . However the single administration of hydrocortisone has not been rigorously evaluated in any trial . Methods In this prospect i ve multicenter cluster study , 259 subjects were included . Administration of low-dose steroids composed the steroid group ( n = 102 ) . Results Although there were more patients in the steroid group who received norepinephrine before brain death ( 80 % vs. 66 % : P = 0.03 ) , mean dose of vasopressor administered after brain death was significantly lower than in the control group ( 1.18 ± 0.92 mg/H vs. 1.49 ± 1.29 mg/H : P = 0.03 ) , duration of vasopressor support use was shorter ( 874 min vs. 1160 min : P < 0.0001 ) and norepinephrine weaning before aortic clamping was more frequent ( 33.8 % vs. 9.5 % : P < 0.0001 ) . Using a survival approach , probability of norepinephrine weaning was significantly different between the two groups ( P < 0.0001 ) with a probability of weaning 4.67 times higher in the steroid group than in the control group ( 95 % CI : 2.30 – 9.49 ) . Conclusions Despite no observed benefits of the steroid administration on primary function recovery of transplanted grafts , administration of glucocorticoids should be a part of the resuscitation management of deceased donors with hemodynamic instability BACKGROUND Lung transplantation activity is frustrated by donor lung availability . We sought to examine the effect of active donor management and hormone administration on pulmonary function and yield in cadaveric heart-beating potential lung donors . METHODS We studied 182 potential lung donors ( arterial oxygen tension [PaO2]/fractional inspired oxygen [ FIO2 ] ratio > or = 230 ) . From this group , 60 patients ( 120 lungs ) were allocated , within a r and omized trial , to receive methylprednisolone ( 1 g ) , triiodothyronine ( 0.8 microg/kg bolus and 0.113 microg/kg/h infusion ) , both methylprednisolone and triiodothyronine , or placebo as soon as feasible after consent and initial assessment . Trial donors underwent protocol -guided optimization of ventilation and hemodynamics , lung water assessment , and bronchoscopy . Function was assessed by PaO2/FIO2 ratio , extravascular lung water index ( EVLWI ) , and pulmonary vascular resistance ( PVR ) . A nontrial group of 122 donors ( 244 lungs ) received similar management without bronchoscopy , pulmonary artery flotation catheter monitoring , or lung water assessment . RESULTS \n Output:\n " }, { "from": "agent", "value": "In the face of these results , administering or withholding steroids both appear reasonable courses of action" } ]

[ { "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 a multinational , double-blind , placebo-controlled trial ( NCT00474058 ) , 287 subjects with Parkinson 's disease ( PD ) and unsatisfactory early-morning motor symptom control were r and omized 2:1 to receive rotigotine ( 2–16 mg/24 hr [ n = 190 ] ) or placebo ( n = 97 ) . Treatment was titrated to optimal dose over 1–8 weeks with subsequent dose maintenance for 4 weeks . Early-morning motor function and nocturnal sleep disturbance were assessed as co primary efficacy endpoints using the Unified Parkinson 's Disease Rating Scale ( UPDRS ) Part III ( Motor Examination ) measured in the early morning prior to any medication intake and the modified Parkinson 's Disease Sleep Scale ( PDSS-2 ) ( mean change from baseline to end of maintenance [ EOM ] , last observation carried forward ) . At EOM , mean UPDRS Part III score had decreased by −7.0 points with rotigotine ( from a baseline of 29.6 [ st and ard deviation ( SD ) 12.3 ] and by −3.9 points with placebo ( baseline 32.0 [ 13.3 ] ) . Mean PDSS-2 total score had decreased by −5.9 points with rotigotine ( from a baseline of 19.3 [ SD 9.3 ] ) and by −1.9 points with placebo ( baseline 20.5 [ 10.4 ] ) . This represented a significantly greater improvement with rotigotine compared with placebo on both the UPDRS Part III ( treatment difference : −3.55 [ 95 % confidence interval ( CI ) −5.37 , −1.73 ] ; P = 0.0002 ) and PDSS-2 ( treatment difference : −4.26 [ 95 % CI −6.08 , −2.45 ] ; P < 0.0001 ) . The most frequently reported adverse events were nausea ( placebo , 9 % ; rotigotine , 21 % ) , application site reactions ( placebo , 4 % ; rotigotine , 15 % ) , and dizziness ( placebo , 6 % ; rotigotine 10 % ) . Twenty-four-hour transdermal delivery of rotigotine to PD patients with early-morning motor dysfunction result ed in significant benefits in control of both motor function and nocturnal sleep disturbances . © 2010 Movement Disorder ABSTRACT – The effects of bromocriptine in patients with Parkinson 's disease manifesting various problems in levodopa therapy were tested in a double‐blind manner with the collaboration of 59 institutions . The slow and low principle was in part adopted . Either bromocriptine or placebo was added to levodopa Abstract Objective : Rasagiline is a second-generation , irreversible MAO-B inhibitor ( MAOB-I ) previously shown to be efficacious and well-tolerated compared to placebo in the treatment of early Parkinson ’s disease ( PD ) . ACTOR ( ACceptabilité TOlérance Rasagiline ) was a 15-week , multi-center , r and omized , double-blind study aim ed to assess the safety and tolerability of rasagiline compared to the dopaminergic agonist pramipexole in the treatment of early PD . Methods : Patients with early , untreated idiopathic PD were r and omized to receive 1 mg rasagiline ( n = 53 ) or 1.5 mg pramipexole ( n = 56 ) daily . The primary outcome was the number of patients experiencing a ‘ clinical ly important adverse event ’ ( classified as a serious adverse event , an event leading to withdrawal or severe according to the patient ) . Safety outcomes were evaluated by the investigator and the patient . Analysis of the primary criterion was a comparative analysis using the chi-squared test . The Wilcoxon Mann – Whitney test was conducted to test the severity of patient-reported adverse events . Other tests performed include a covariance analysis and Student ’s t-tests . Results : Mean disease duration was 3.4 months , and mean age was 62.6 years . Of patients taking pramipexole , 44.6 % reported at least one ‘ clinical ly important ’ adverse event compared to 32.1 % of patients taking rasagiline ; non-inferiority of rasagiline was reached , with a difference in proportions of −12.6 % [ confidence interval of −27.8 % ; 2.6 % ] . There were no significant differences in clinical effectiveness between the treatments , measured by clinical and patient global impression of improvement ( CGI-I , PGI-I ) and PDQ-8 scales . A significant decrease in the incidence of gastrointestinal symptoms ( p = 0.015 ) and sleep disorders ( p = 0.027 ) was reported by physicians in the rasagiline group compared to the pramipexole group ; the propensity to sleepiness improved significantly in the rasagiline group ( p = 0.020 ) , and worsened in the pramipexole group ( p = 0.042 ) . Limitations : Limitations of this study include the limited sample size due to the lower than anticipated recruitment and the accidental inclusion of a patient who had taken contraindicated medication . Conclusions : In this study , the safety profile of rasagiline had clinical ly favorable differences in gastrointestinal and sleep adverse events compared to pramipexole , whilst showing comparable clinician and patient-rated clinical effectiveness as a monotherapy for the treatment of early idiopathic PD BACKGROUND There is debate about whether the initial treatment for patients with Parkinson 's disease should be levodopa or a dopamine agonist . METHODS In this prospect i ve , r and omized , double-blind study , we compared the safety and efficacy of the dopamine D2-receptor agonist ropinirole with that of levodopa over a period of five years in 268 patients with early Parkinson 's disease . If symptoms were not adequately controlled by the assigned study medication , patients could receive supplementary levodopa , administered in an open-label fashion . The primary outcome measure was the occurrence of dyskinesia . RESULTS Eighty-five of the 179 patients in the ropinirole group ( 47 percent ) and 45 of the 89 patients in the levodopa group ( 51 percent ) completed all five years of the study . In the ropinirole group 29 of the 85 patients ( 34 percent ) received no levodopa supplementation . The analysis of the time to dyskinesia showed a significant difference in favor of ropinirole ( hazard ratio for remaining free of dyskinesia , 2.82 ; 95 percent confidence interval , 1.78 to 4.44 ; P<0.001 ) . At five years , the cumulative incidence of dyskinesia ( excluding the three patients who had dyskinesia at base line ) , regardless of levodopa supplementation , was 20 percent ( 36 of 177 patients ) in the ropinirole group and 45 percent ( 40 of 88 patients ) in the levodopa group . There was no significant difference between the two groups in the mean change in scores for activities of daily living among those who completed the study . Adverse events led to the early withdrawal from the study of 48 of 179 patients in the ropinirole group ( 27 percent ) and 29 of 89 patients in the levodopa group ( 33 percent ) . The mean ( + /-SD ) daily doses given by the end of the study were 16.5+/-6.6 mg of ropinirole ( plus 427+/-221 mg of levodopa in patients who received supplementation ) and 753+/-398 mg of levodopa ( including supplements ) . CONCLUSIONS Early Parkinson 's disease can be managed successfully for up to five years with a reduced risk of dyskinesia by initiating treatment with ropinirole alone and supplementing it with levodopa if necessary OBJECTIVE This study compares once-daily ropinirole 24-h prolonged release and three-times-daily ropinirole immediate release in patients with early Parkinson 's disease . METHODS This multicentre , double-blind , non-inferiority crossover study involved 161 patients r and omized to one of four formulation sequences : ( 1 ) immediate release-immediate release-prolonged release ; ( 2 ) immediate release-prolonged release-prolonged release ; ( 3 ) prolonged release-prolonged release-immediate release ; ( 4 ) prolonged release-immediate release-immediate release . During a 12-week dose-titration period , ropinirole immediate release was titrated according to the approved labelling ; titration of ropinirole 24-h prolonged release started at a higher dose and was more rapid . Patients then entered three consecutive , flexible-dose , 8-week maintenance periods . At the end of the first maintenance period , half of the patients in each formulation group switched to the same or closest dose of the alternative formulation ; remaining patients switched at the end of the second maintenance period . RESULTS At the end of titration , before the first dose switch , there were substantial reductions in mean Unified Parkinson 's Disease Rating Scale ( UPDRS ) motor scores . During maintenance periods , both groups showed similar efficacy on the UPDRS motor score . Overall mean ( st and ard error ) change from period baseline was -0.1 ( 0.28 ) for ropinirole 24-h prolonged release , and 0.6 ( 0.30 ) for ropinirole immediate release ( adjusted mean treatment difference -0.7 ; 95 % confidence interval [ CI ] : -1.51 , 0.10 ; p = 0.0842 ) . The upper limit of the 95 % CI was less than the predefined threshold of 3 points for non-inferiority . Ropinirole 24-h prolonged release was well-tolerated when titrated more rapidly than ropinirole immediate release ; overnight switching between formulations was also well-tolerated . Study limitations included complexity of the non-inferiority study design and the forced dose-titration schedule . CONCLUSION Ropinirole 24-h prolonged release was effective and well-tolerated in patients with early Parkinson 's disease We compared the antitremor effect of pramipexole , pergolide , or placebo in Parkinson 's disease ( PD ) . A double-blind , r and omly controlled , parallel protocol was deployed to examine the effects of placebo , pergolide , and pramipexole [ doses escalated to 1.5 mg three times daily ( t.i.d . ) over 3 months ] on a compound Tremor Index ( TI ) and Unified Parkinson 's Disease Rating Scale ( UPDRS ) part III . Thirty PD patients ( 19 men , 11 women ; mean age 69 years , range 54 - 80 years ; mean disease duration 3.9 years , range , 0.5 - 10 years ) participated in the study , with 10 patients in each arm . Six subjects failed to complete the study ( 4 on pergolide and 2 on placebo ) . Analysis of covariance demonstrated strong evidence for a treatment effect on both TI and UPDRS III . There was no significant difference between the active treatments on either TI or UPDRS III . Both pergolide and pramipexole were significantly better than placebo . The results indicate that pergolide and pramipexole ( 1.5 mg t.i.d . ) have similar anti-PD tremor and UPDRS III actions that are significantly superior to placebo . Patients on pergolide were more likely to drop out because of adverse events than those on pramipexole We compared the efficacy , safety , an tolerability of pramipexole , an aminobenzathiazol-derived dopamine agonist with novel properties , with those of placebo in advanced PD patients with motor fluctuations under levodopa treatment . Pramipexole improved motor function of patients during \" on \" and \" off \" periods , decreased the time spent in \" off \" periods , reduced the severity of \" off \" periods , decreased disability and PD severity during \" on \" and \" off \" periods , as assessed by the Unified Parkinson Disease Rating Scale , and permitted a reduction in levodopa dosage . Adverse effects related to the central nervous system were similar to those reported with other dopamine agonists , and the gastrointestinal and cardiovascular tolerability of the compound was satisfactory OBJECTIVE The common cold ( acute viral respiratory tract infection ) is one of the most frequent diseases in man , world-wide . Clinical ly relevant efficacy should include early improvement of all symptoms . Results of a clinical trial of a commercially available fixed combination herbal remedy ( Radix echinaceae , Radix baptisiae , Herba thujae ) are reported here . The aim of this study was to verify clinical efficacy shown in recent studies under ( i ) good clinical practice ( GCP ) quality assurance and ( ii ) common situations at family doctors . METHODS Patients attending one of 15 study centres ( practitioners ) as a result of an acute common cold were r and omised to the double-blind placebo-controlled study . Three tablets of study medication were applied t.i.d . for 7 to 9 days . Patients daily documented the intensity of 18 cold symptoms , as well as the cold overall , using a 10-point scale and estimated their general well-being using the Welzel-Kohnen colour scales . Additionally , the severity of illness was assessed by the physician on days 4 and 8 ( CGI-1 ) . The main and confirmatory outcome measure was expressed as a total efficacy value . This was gauged from the z-st and ardised AUC values of the primary endpoints ( \n Output:\n " }, { "from": "agent", "value": "Results of NMA indicate that patients with levodopa , pramipexole , ropinirole and selegiline exhibited a significantly improved UPDRS III than those with lazabemide .\nTo sum up , levodopa , selegiline , ropinirole and rotigotine were recommended for PD patients as they appeared relatively high efficacy and tolerability" } ]

[ { "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 The aim of the present study was to determine if a sugarless mint containing CaviStat ( an arginine bicarbonate calcium carbonate complex ) is capable of preventing the development of dental caries in the primary molars and first permanent molars of 10 1/2- to 11-year-old Venezuelan children . METHODS Two-hundred children were entered into this one-year study who showed the following : ( i ) age between 10 1/2 and 11 years ; ( ii ) first and second primary molars still present ; ( iii ) sound primary molars or early caries lesions in any of these teeth ; and ( iv ) at least some caries in the primary or permanent teeth as evidence of caries activity . Out of the 200 children initially selected , 195 finished and provided complete data . Children entered into the study were examined and then r and omly divided into two groups ( A and B ) , with distribution performed on the basis of the DMFS levels of the first permanent molars . All subjects were examined visually by a single examiner using good artificial light , mirror , and probe . Group A received a sugarless confection containing CaviStat ( BasicMints ) ; Group B received a sugarless mint control that contained all ingredients except for the CaviStat . Packaging and appearance of both types of mints were identical , except for their A and B design ations . RESULTS Mean differences in DMFS , defs , and DMFS + defs scores between Groups A and B were determined . In the first permanent molars and some early erupting premolars and second molars , the data showed 75.6 % fewer caries in Group A than in Group B children after six months , and 50.7 % fewer after 12 months . Corresponding defs scores showed reduced development of dental caries in deciduous molars of 76.7 % after six months and 131.3 % after 12 months . Combined DMFS and defs scores showed 76.2 and 74.8 % fewer caries lesions at six and 12 months , respectively . As exfoliation of primary molars occurred during the study period ( approximately equal in the two groups ) , a proportion correction was made to allow for caries score reductions due to lesions lost because of such exfoliation . When this was done , the results at the end of the study still showed larger caries reductions in Group A than in the Group B subjects , and statistical analyses showed these differences were still highly significant ( p < 0.001 ) . Noncavitated caries lesions in the first permanent molars were also determined . These showed once again less caries development in Group A than in Group B subjects , and did so at both six and twelve months ( 57.0 and 52.4 % , respectively ) . Levels of statistical significance at these times were p = 0.013 and 0.005 . CONCLUSION It was evident from this clinical trial that mint confections containing CaviStat are able to inhibit both caries onset and caries progression . As a result , one can conclude that CaviStat mint confection technology is a simple and economical means for reducing substantially one of the most prevalent diseases in these children Objective : We aim ed to evaluate the efficacy of oral hygiene instruction , fluoride varnish and casein phosphopeptide-amorphous calcium phosphate ( CPP-ACP ) for remineralizing white spot lesions ( WSL ) , and the effect of these on the dmft index in primary teeth . Subjects and Methods : In this 1-year , r and omized clinical trial , 140 children aged 12 - 36 months with WSL in the anterior maxillary teeth were selected and r and omly divided into 4 groups of 35 children each . Group 1 ( control ) received no preventive intervention . In group 2 , there was oral hygiene and dietary counseling . In group 3 , there was oral hygiene and the application of fluoride varnish at 4 , 8 and 12 months after baseline . In group 4 , there was oral hygiene and tooth mousse was applied by the parents twice a day over a 12-month period . At baseline and 4 , 8 and 12 months after the intervention , the size of WSL in millimeters and the dmft index were recorded . One hundred and twenty-two children completed the study . Data were analyzed using the repeated- measures ANOVA test . Results : In group 1 , the mean percent WSL area and dmft index values had increased significantly at 12 months after baseline ( p < 0.001 ) . The interventions led to significant decreases in the size of the WSL ; the greatest reduction was in group 4 ( 63 % ) followed by group 3 ( 51 % ) and group 2 ( 10 % ) after 12 months . The smallest increase in the dmft index was in group 4 ( 0.17 ) , followed by groups 3 ( 0.3 ) and 2 ( 0.42 ) . However , there were no significant differences between the groups ( p < 0.001 ) . Conclusions : Oral hygiene along with four fluoride varnish applications or constant CPP-ACP during the 12- month period reduced the size of WSL in the anterior primary teeth and caused a small increase in dmft index values PURPOSE The purpose of this study was to compare twice daily tooth-brushing using 0.304 percent fluoride toothpaste alone with : ( 1 ) twice daily tooth-brushing plus once daily 10 % casein phosphopeptide-amorphous calcium phosphate ( CPP-ACP ) paste ; and ( 2 ) twice daily tooth-brushing plus once daily 0.12 % chlorhexidine gel ( CHX ) for reducing early childhood caries ( ECC ) and mutans streptococci ( MS ) colonization . METHODS Subjects ( n=622 ) recruited at birth were r and omized to receive either CPP-ACP or CHX or no product ( study control [ SC ] ) . All children were examined at 6 , 12 , and 18 months old in their homes , and at 24 months old in a community dental clinic . RESULTS At 24 months old , the caries incidence was 1 % ( 2/163 ) in CPP-ACP , 2 % ( 4/180 ) in CHX , and 2 % ( 3/188 ) in SC groups . In children who were previously MS colonized at 12 and 18 months old , 0 % ( 0/11 ) and 5 % ( 3/63 ) , respectively , of the CPP-ACP group remained MS-positive versus 22 % ( 2/9 ) and 72 % ( 18/25 ) in CHX and 16 % ( 4/25 ) and 50 % ( 7/14 ) in SC groups ( P<.001 ) . CONCLUSIONS There is insufficient evidence to justify the daily use of casein phosphopeptide-amorphous calcium phosphate or chlorhexidine gel to control early childhood caries OBJECTIVES . This r and omised , controlled trial compared the effectiveness of 0.12 % chlorhexidine ( CHX ) gel and 304 % fluoride toothpaste to prevent early childhood caries ( ECC ) in a birth cohort by 24 months . METHODS . The participants were r and omised to receive either ( i ) twice daily toothbrushing with toothpaste and once daily 0.12 % CHX gel ( n = 110 ) or ( ii ) twice daily toothbrushing with toothpaste only ( study controls ) ( n = 89 ) . The primary outcome measured was caries incidence and the secondary outcome was percentage of children with mutans streptococci ( MS ) . All mothers were contacted by telephone at 6 , 12 , and 18 months . At 24 months , all children were examined at a community dental clinic . RESULTS . At 24 months , the caries prevalence was 5 % ( 3/61 ) in the CHX and 7 % ( 4/58 ) in the controls ( P = 0.7 ) . There were no differences in percentages of MS-positive children between the CHX and control groups ( 54%vs 53 % ) . Only 20 % applied the CHX gel once daily and 80 % less than once daily . CONCLUSIONS . Toothbrushing using 304 % fluoride toothpaste with or without the application of chlorhexidine gel ( 0.12 % ) reduces ECC from 23 % found in the general community to 5 - 7 % . The lack of effect with chlorhexidine is likely to be due to low compliance All field studies have unequivocally reported significant reductions in dental caries occurrence associated with the use of chewing gum containing xylitol . No other xylitol products besides chewing gum have so far been tested in field trials . A 5-year follow-up study with 2- or 3-year xylitol consumption periods began in Estonia in 1994 with 740 10-year-old children in 12 schools at baseline examinations . For the study , 3 clusters each including 3 - 5 schools were formed on the basis of baseline caries experience . The products were used under the supervision of the teachers 3 times per day during school days but not during weekends or during the 3-month summer holiday . The daily dose of xylitol was 5 g in all groups . The children were examined every year in September by two experienced clinicians . Dental caries was recorded according to WHO criteria . After 3 years , all xylitol groups showed a highly significant 35%-60 % reduction in caries incident , compared with the corresponding control groups . The differences between c and ies , between c and ies and chewing gum , and between 2- and 3-year users in the xylitol groups were non- systematic , indicating no trends between the groups . The results suggest that not only xylitol chewing gum but also xylitol c and ies are effective in caries prevention , and that a school-based delivery system seems to offer a practical way to distribute and control the use of the xylitol products OBJECTIVE The aim of this study was to investigate the caries prevention efficacy of chlorhexidine-thymol ( CHX-T ) varnish on newly erupted permanent first molars . METHODS Fifty-seven six- to eight-year-old school children were included in a program of sequential CHX-T varnish application . For inclusion , they had to have at least two homologous , newly erupted first permanent molars with visually sound occlusal surfaces . A clinical examination was used to determine the molar eruption stage , biofilm presence , and whole caries status . There were 99 pairs of molars in the study population . A split-mouth design was used where each child r and omly had one first molar treated with six applications of CHX-T varnish , and the other with a placebo varnish , every 15 days for 75 days . The children were then revaluated for caries one year following the conclusion of treatment . RESULTS Fourteen pairs of teeth presented incipient enamel caries lesions in both molars ( one CHX-T and one placebo varnish ) , four developed lesions in the placebo-treated molars only , and eight developed lesions in CHX-T varnish-treated molar only . No significant statistical differences were found between the two groups with regard to caries increment ( p = 0.20 ) . CONCLUSION Six applications of CHX-T varnish had no protective effect against caries development Objective . The aim was to investigate the effect of high and low amounts of xylitol on the interdental plaque-pH , directly and after sucrose challenge , in schoolchildren with habitual consumption . Material and methods . The study group consisted of 11 healthy children ( 10–15 years ) with low caries risk and the experiment had a single-blind crossover ( Latin square ) design . After a 2-week run-in period with a daily 4.0 g xylitol intake , the children were subjected to single-dose exposures of chewing gums with ( i ) paraffin ( CTR ; no xylitol ) , ( ii ) low-dose xylitol ( LX ; 2.0 g xylitol ) , and ( iii ) high-dose xylitol ( HX ; 6.0 g xylitol ) in a r and omized order separated by a washout period of 1 week . Sample s of chewing-stimulated whole saliva were collected prior to and after the experimental period for determination of bacterial counts . The outcome measures were in situ plaque-pH ( micro-touch method ) and area under the pH curve ( AUC ) . Results . The AUC was significantly greater ( p<0.05 ) in the HX group compared to the LX and control groups during the first 5 min after chewing . After a 10 % sucrose rinse , the interdental plaque-pH dropped in all groups but the HX regimen displayed significantly less reduction 0–5 min after chewing ( p<0.05 ) . No significant alterations of the total viable counts or mutans streptococci levels in saliva were disclosed during the 4-week experimental period . Conclusions . The present results suggested that a high single dose of xylitol had a short and limited beneficial effect on interdental plaque-pH in habitual xylitol consumers , while a low single dose , resembling normal chewing gum use , did not differ from the control The aim was to evaluate the effect of chlorhexidine gel treatment on the incidence of approximal caries in preschool children . One hundred and seventeen 4-year-olds , divided into two groups , participated : ( 1 ) chlorhexidine gel group ( n = 59 ) , and ( 2 ) placebo gel group ( n = 58 ) . Group 1 was treated 4 times a year with a 1 % chlorhexdine gel and group 2 with a placebo gel . Approximately 0.7 ml of gel was applied interdentally by means of a flat dental floss . A control group ( group 3 ) , which did not receive any flossing or \n Output:\n " }, { "from": "agent", "value": "There is evidence that the use of certain doses of xylitol may be effective in arresting dental caries in primary dentition .\nChlorhexidine and CPP-ACP may be more effective than a placebo in managing caries in primary dentition , but their effectiveness is borderline when compared with fluoride .\nArginine-containing mint confection and 0.3 % triclosan varnish were found to reduce caries development in primary teeth but the evidence was at high risk of bias ." } ]

[ { "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 height gain of vertebral bodies after vertebroplasty and geometrical stability was evaluated over a one-year period . Osteoporotic fractures were treated with vertebroplasty . The vertebral geometry and disc spaces were analysed using reformatted computed tomography ( CT ) images : heights of the anterior , posterior , and lateral vertebral walls , disc spaces , endplate angles , and minimal endplate distances . Vertebrae were assigned to group I [ severe compression ( anterior height/posterior height ) < 0.75 ] and group II ( moderate compression index > 0.75 ) . A total of 102 vertebral bodies in 40 patients ( 12 men , 28 women , age 70.3 ± 9.5 ) were treated with vertebroplasty and prospect ively followed for 12 months . Group I showed a greater benefit compared with group II with respect to anterior height gain ( + 2.1 ± 1.9 vs + 0.7 ± 1.6 mm , P < 0.001 ) , reduction of endplate angle ( −3.6 ± 4.2 vs −0.8 ± 2.3 ° , P < 0.001 ) , and compression index ( + 0.09 ± 0.11 vs + 0.01 ± 0.06 , P < 0.001 ) . At one-year follow-up , group I demonstrated preserved anterior height gain ( + 1.5 ± 2.8 mm , P < 0.015 ) and improved endplate angle ( −3.4 ± 4.9 ° , P < 0.001 ) . In group II , the vertebral heights returned to and were fixed at the pre-interventional levels . Vertebroplasty provided vertebral height gain over one year , particularly in cases with severe compression . Vertebrae with moderate compression were fixed and stabilized at the pre-treatment level over one year BACKGROUND Previous studies have shown that alendronate can increase bone mineral density ( BMD ) and prevent radiographically defined ( morphometric ) vertebral fractures . The Fracture Intervention Trial aim ed to investigate the effect of alendronate on the risk of morphometric as well as clinical ly evident fractures in postmenopausal women with low bone mass . METHODS Women aged 55 - 81 with low femoral-neck BMD were enrolled in two study groups based on presence or absence of an existing vertebral fracture . Results for women with at least one vertebral fracture at baseline are reported here . 2027 women were r and omly assigned placebo ( 1005 ) or alendronate ( 1022 ) and followed up for 36 months . The dose of alendronate ( initially 5 mg daily ) was increased ( to 10 mg daily ) at 24 months , with maintenance of the double blind . Lateral spine radiography was done at baseline and at 24 and 36 months . New vertebral fractures , the primary endpoint , were defined by morphometry as a decrease of 20 % ( and at least 4 mm ) in at least one vertebral height between the baseline and latest follow-up radiograph . Non-spine clinical fractures were confirmed by radiographic reports . New symptomatic vertebral fractures were based on self-report and confirmed by radiography . FINDINGS Follow-up radiographs were obtained for 1946 women ( 98 % of surviving participants ) . 78 ( 8.0 % ) of women in the alendronate group had one or more new morphometric vertebral fractures compared with 145 ( 15.0 % ) in the placebo group ( relative risk 0.53 [ 95 % Cl 0.41 - 0.68 ] ) . For clinical ly apparent vertebral fractures , the corresponding numbers were 23 ( 2.3 % ) alendronate and 50 ( 5.0 % ) placebo ( relative hazard 0.45 [ 0.27 - 0.72 ] ) . The risk of any clinical fracture , the main secondary endpoint , was lower in the alendronate than in the placebo group ( 139 [ 13.6 % ] vs 183 [ 18.2 % ] ; relative hazard 0.72 [ 0.58 - 0.90 ] ) . The relative hazards for hip fracture and wrist fracture for alendronate versus placebo were 0.49 ( 0.23 - 0.99 ) and 0.52 ( 0.31 - 0.87 ) . There was no significant difference between the groups in numbers of adverse experiences , including upper-gastrointestinal disorders . INTERPRETATION We conclude that among women with low bone mass and existing vertebral fractures , alendronate is well tolerated and substantially reduces the frequency of morphometric and clinical vertebral fractures , as well as other clinical fractures Previously , we reported significantly reduced pain and improved mobility persisting for 6 months after kyphoplasty of chronically painful osteoporotic vertebral fractures in the first prospect i ve controlled trial . Since improvement of spinal biomechanics by restoration of vertebral morphology may affect the incidence of fracture , long-term clinical benefit and thereby cost-effectiveness , here we extend our previous work to assess occurrence of new vertebral fractures and clinical parameters 1 year after kyphoplasty compared with a conservatively treated control group . Sixty patients with osteoporotic vertebral fractures due to primary osteoporosis were included : 40 patients were treated with kyphoplasty , 20 served as controls . All patients received st and ard medical treatment . Morphological characteristics , new vertebral fractures , pain ( visual analog scale ) , physical function [ European Vertebral Osteoporosis Study ( EVOS ) score ] ( range 0–100 each ) and back-pain-related doctors ’ visits were re-assessed 12 months after kyphoplasty . There were significantly fewer patients with new vertebral fractures of the thoracic and lumbar spine , after 12-months , in the kyphoplasty group than in the control group ( P=0.0084 ) . Pain scores improved from 26.2 to 44.4 in the kyphoplasty group and changed from 33.6 to 34.3 in the control group ( P=0.008 ) . Kyphoplasty treated patients required a mean of 5.3 back-pain-related doctors ’ visits per patient compared with 11.6 in the control group during 12 months follow-up ( P=0.006 ) . Kyphoplasty as an addition to medical treatment and when performed in appropriately selected patients by an interdisciplinary team persistently improves pain and reduces occurrence of new vertebral fractures and healthcare utilization for at least 12 months in individuals with primary osteoporosis Vertebroplasty and kyphoplasty are associated with a recurrent fracture rate of 2.4 % to 23 % , which is lower than the general natural history of untreated osteoporotic fractures . Some authors suggest the risk of refracture at adjacent vertebra will be reduced by prophylactic stabilization . We therefore compared the refracture rate after prophylactic balloon kyphoplasty in 60 patients r and omized into groups with either monosegmental balloon kyphoplasty or adjacent prophylactic balloon kyphoplasty . The level ( superior versus inferior ) for prophylactic stabilization was chosen according to fracture type . We evaluated patients for 12 months using radiographs , visual analog scale scores , and SF-36 scores . We followed 23 of 30 patients in the monosegmental group and 27 of 30 patients in the prophylactic group . We observed no difference in the 1-year refracture rates between the two groups ( five patients in the monosegmental group and seven in the prophylactic group ) . Leakage into the disc was the presumed cause of adjacent fractures in 50 % of the patients . Disc leakage and refracture rate did not correlate as a result of the low patient number . Based on our data , we believe there is no indication for prophylactic stabilization of adjacent segments with balloon kyphoplasty . Level of Evidence : Level II , therapeutic study . See the Guidelines for Authors for a complete description of levels of evidence BACKGROUND Balloon kyphoplasty is a minimally invasive procedure for the treatment of painful vertebral fractures , which is intended to reduce pain and improve quality of life . We assessed the efficacy and safety of the procedure . METHODS Adults with one to three acute vertebral fractures were eligible for enrolment in this r and omised controlled trial at 21 sites in eight countries . We r and omly assigned 300 patients by a computer-generated sequence to receive kyphoplasty treatment ( n=149 ) or non-surgical care ( n=151 ) . The primary outcome was the difference in change from baseline to 1 month in the short-form (SF)-36 physical component summary ( PCS ) score ( scale 0 - 100 ) between the kyphoplasty and control groups . Quality of life and other efficacy measurements and safety were assessed up to 12 months . Analysis was by intention to treat . This trial is registered with Clinical Trials.gov , number NCT00211211 . FINDINGS 138 participants in the kyphoplasty group and 128 controls completed follow-up at 1 month . By use of repeated measures mixed effects modelling , all 300 r and omised participants were included in the analysis . Mean SF-36 PCS score improved by 7.2 points ( 95 % CI 5.7 - 8.8 ) , from 26.0 at baseline to 33.4 at 1 month , in the kyphoplasty group , and by 2.0 points ( 0.4 - 3.6 ) , from 25.5 to 27.4 , in the non-surgical group ( difference between groups 5.2 points , 2.9 - 7.4 ; p<0.0001 ) . The frequency of adverse events did not differ between groups . There were two serious adverse events related to kyphoplasty ( haematoma and urinary tract infection ) ; other serious adverse events ( such as myocardial infa rct ion and pulmonary embolism ) did not occur perioperatively and were not related to procedure . INTERPRETATION Our findings suggest that balloon kyphoplasty is an effective and safe procedure for patients with acute vertebral fractures and will help to inform decisions regarding its use as an early treatment option BACKGROUND Percutaneous vertebroplasty is increasingly used for treatment of pain in patients with osteoporotic vertebral compression fractures , but the efficacy , cost-effectiveness , and safety of the procedure remain uncertain . We aim ed to clarify whether vertebroplasty has additional value compared with optimum pain treatment in patients with acute vertebral fractures . METHODS Patients were recruited to this open-label prospect i ve r and omised trial from the radiology departments of six hospitals in the Netherl and s and Belgium . Patients were aged 50 years or older , had vertebral compression fractures on spine radiograph ( minimum 15 % height loss ; level of fracture at Th5 or lower ; bone oedema on MRI ) , with back pain for 6 weeks or less , and a visual analogue scale ( VAS ) score of 5 or more . Patients were r and omly allocated to percutaneous vertebroplasty or conservative treatment by computer-generated r and omisation codes with a block size of six . Masking was not possible for participants , physicians , and outcome assessors . The primary outcome was pain relief at 1 month and 1 year as measured by VAS score . Analysis was by intention to treat . This study is registered at Clinical Trials.gov , number NCT00232466 . FINDINGS Between Oct 1 , 2005 , and June 30 , 2008 , we identified 431 patients who were eligible for r and omisation . 229 ( 53 % ) patients had spontaneous pain relief during assessment , and 202 patients with persistent pain were r and omly allocated to treatment ( 101 vertebroplasty , 101 conservative treatment ) . Vertebroplasty result ed in greater pain relief than did conservative treatment ; difference in mean VAS score between baseline and 1 month was -5·2 ( 95 % CI -5·88 to -4·72 ) after vertebroplasty and -2·7 ( -3·22 to -1·98 ) after conservative treatment , and between baseline and 1 year was -5·7 ( -6·22 to -4·98 ) after vertebroplasty and -3·7 ( -4·35 to -3·05 ) after conservative treatment . The difference between groups in reduction of mean VAS score from baseline was 2·6 ( 95 % CI 1·74 - 3·37 , p<0·0001 ) at 1 month and 2·0 ( 1·13 - 2·80 , p<0·0001 ) at 1 year . No serious complications or adverse events were reported . INTERPRETATION In a subgroup of patients with acute osteoporotic vertebral compression fractures and persistent pain , percutaneous vertebroplasty is effective and safe . Pain relief after vertebroplasty is immediate , is sustained for at least a year , and is significantly greater than that achieved with conservative treatment , at an acceptable cost . FUNDING ZonMw ; COOK Medical PURPOSE Kyphoplasty and vertebroplasty offer two minimally invasive operative stabilization procedures for vertebral compression fractures . The purpose of this prospect i ve study was to investigate whether both procedures are able to reduce pain and to preserve postoperative vertebral height during a 1-year follow up . \n Output:\n " }, { "from": "agent", "value": "The combined odds ratio of vertebroplasty and kyphoplasty versus conservative treatment , namely 0.96 , gave a hint that there might be little difference ." } ]

[ { "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 Applying mobile phones in healthcare is increasingly prioritized to strengthen healthcare systems . Antenatal care has the potential to reduce maternal morbidity and improve newborns ’ survival but this benefit may not be realized in sub-Saharan Africa where the attendance and quality of care is declining . We evaluated the association between a mobile phone intervention and antenatal care in a re source -limited setting . We aim ed to assess antenatal care in a comprehensive way taking into consideration utilisation of antenatal care as well as content and timing of interventions during pregnancy . Methods This study was an open label pragmatic cluster-r and omised controlled trial with primary healthcare facilities in Zanzibar as the unit of r and omisation . 2550 pregnant women ( 1311 interventions and 1239 controls ) who attended antenatal care at selected primary healthcare facilities were included at their first antenatal care visit and followed until 42 days after delivery . 24 primary health care facilities in six districts were r and omized to either mobile phone intervention or st and ard care . The intervention consisted of a mobile phone text-message and voucher component . Primary outcome measure was four or more antenatal care visits during pregnancy . Secondary outcome measures were tetanus vaccination , preventive treatment for malaria , gestational age at last antenatal care visit , and antepartum referral . Results The mobile phone intervention was associated with an increase in antenatal care attendance . In the intervention group 44 % of the women received four or more antenatal care visits versus 31 % in the control group ( OR , 2.39 ; 95 % CI , 1.03 - 5.55 ) . There was a trend towards improved timing and quality of antenatal care services across all secondary outcome measures although not statistically significant . Conclusions The wired mothers ’ mobile phone intervention significantly increased the proportion of women receiving the recommended four antenatal care visits during pregnancy and there was a trend towards improved quality of care with more women receiving preventive health services , more women attending antenatal care late in pregnancy and more women with antepartum complications identified and referred . Mobile phone applications may contribute towards improved maternal and newborn health and should be considered by policy makers in re source -limited setting s . Trial registration Clinical Trials.gov , NCT01821222 Background Home visits by Community Health Workers [ In Ug and a Community Health Workers are given the collective term of Village Health Teams ( VHTs ) . Hereafter referred to as VHTs ] is recommended to improve maternal and newborn care . We investigated perceived maternal and newborn benefits of home visits made by VHTs , combined with mobile phone consultations with professional health workers for advice . Methods A qualitative study was conducted in Masindi and Kiry and ongo districts , Ug and a , in December-2013 to March-2014 . Study participants were drawn from the intervention arm of a r and omised community-intervention trial . In-depth interviews were conducted with 20 prenatal and 16 postnatal women who were visited by VHTs ; 5 group discussion s and 16 key informant interviews were held with VHTs and 10 Key Informant Interviews with professional health workers . Data were analysed using latent content analysis techniques . Results Majority women and VHTs contend that the intervention improved access to maternal and newborn information ; reduced costs of accessing care and facilitated referral . Women , VHTs and professional health workers acknowledged that the intervention induced attitudinal change among women and VHTs towards adapting recommended maternal and newborn care practice s. Mobile phone consultations between VHTs and professional health workers were considered to reinforce VHT knowledge on maternal newborn care and boosted the social status of VHTs in community . A minority of VHTs perceived the implementation of recommended maternal and newborn care practice s as difficult . Some professional health workers did not approve of the transfer of promotional maternal and newborn responsibility to VHTs . For a range of reasons , a number of professional health workers were not always available on phone or at the health centre to address VHT concerns . Conclusions Results suggest that home visits made by VHTs for maternal and newborn care are reasonably well accepted . Our study highlights potential benefits of combining home visits with phone consultations between VHTs and professional health workers . However , the challenge of attitudinal change among VHTs towards certain strongly culturally-embedded behavioural post-partum practice s , resistance from part of the professional health workforce to collaborate with VHTs and the problematic availability of professional health workers are important systemic problems that need to be addressed . Trial registration Current Controlled Trials NCT02084680.Registered 14 March 2014 Introduction The World Health Organisation recommends home visits conducted by Community Health Workers ( in Ug and a known as Village Health Teams — VHTs ) in order to improve maternal and newborn health . This study measured the effect of home visits combined with mobile phone consultations on maternal and newborn care practice s. Method In a community intervention trial design 16 health centres in Masindi and Kiry and ongo districts , Ug and a were r and omly and equally allocated to one of two arms : control and intervention arms . Eight control health centres received the usual maternal and newborn educational messages offered by professional health workers and eight intervention health centres that received an intervention package for maternal care and essential newborn care practice s. In the intervention arm VHTs made two prenatal and one postnatal home visit to households . VHTs were provided with mobile phones to enable them make regular telephone consultations with health workers at the health centre serving the catchment area . The primary outcome was health facility delivery . Other outcomes included antenatal attendances , birth preparedness , cord and thermal care and breastfeeding practice s. Analysis was by intention-to-treat . Results A total of 1385 pregnant women were analysed : 758 and 627 in the control and intervention arms respectively . Significant post-intervention differences were : delivery place [ adjusted Odds Ratio aOR : 17.94(95%CI : 6.26–51.37 ) ; p<0.001 ] , cord care [ aOR : 3.05(95%CI : 1.81–5.12 ) ; p<0.001 ] thermal care [ aOR : 7.58(95%CI : 2.52–22.82 ) ; p<0.001 ] , and timely care-seeking for newborn illness [ aOR : 4.93(95%CI : 1.59–15.31 ) ; p = 0.006 ] . Conclusion VHTs can have an effect in promoting proper cord and thermal care for the newborn and improve timely care-seeking for health facility delivery and newborn illness , because they could answer questions and refer patients correctly . However , VHTs should be supported by professional health workers through the use of mobile phones . Trial Registration Clinical Trials.gov Background Although there are studies showing that mobile phone solutions can improve health service delivery outcomes in the developed world , there is little empirical evidence that demonstrates the impact of mHealth interventions on key maternal health outcomes in low income setting s. Methods A non-r and omized controlled study was conducted in the Amhara region , Ethiopia in 10 health facilities ( 5 intervention , 5 control ) together serving around 250,000 people . Health workers in the intervention group received an and roid phone ( 3 phones per facility ) loaded with an application that sends reminders for scheduled visits during antenatal care ( ANC ) , delivery and postnatal care ( PNC ) , and educational messages on dangers signs and common complaints during pregnancy . The intervention was developed at Addis Ababa University in Ethiopia . Primary outcomes were the percentage of women who had at least 4 ANC visits , institutional delivery and PNC visits at the health center after 12 months of implementation of the intervention . Findings Overall 933 and 1037 women were included in the cross-sectional surveys at baseline and at follow-up respectively . In addition , the medical records of 1224 women who had at least one antenatal care visit were followed in the longitudinal study . Women who had their ANC visit in the intervention health centers were significantly more likely to deliver their baby in the same health center compared to the control group ( 43.1 % versus 28.4 % ; Adjusted Odds Ratio ( AOR ) : 1.98 ( 95%CI 1.53–2.55 ) ) . A significantly higher percentage of women who had ANC in the intervention group had PNC in the same health center compared to the control health centers ( 41.2 % versus 21.1 % : AOR : 2.77 ( 95%CI 2.12–3.61 ) ) . Conclusions Our findings demonstrated that a locally customized mHealth application during ANC can significantly improve delivery and postnatal care service utilization possibly through positively influencing the behavior of health workers and their clients Objective : Many sub-Saharan African countries report high postpartum loss to follow-up of mother – baby pairs . We aim ed to determine whether interactive text messages improved rates of clinic attendance and early infant HIV testing in the Nyanza region of Kenya . Design : Parallel-group , unblinded , r and omized controlled trial . Methods : HIV-positive pregnant women at least 18 years old and enrolled in the prevention of mother-to-child transmission of HIV programme were r and omized to receive either text messages ( SMS group , n = 195 ) or usual care ( n = 193 ) . Messages were developed using formative focus group research informed by constructs of the Health Belief Model . The SMS group received up to eight text messages before delivery ( depending on gestational age ) , and six messages postpartum . Primary outcomes included maternal postpartum clinic attendance and virological infant HIV testing by 8 weeks postpartum . The primary analyses were intention-to-treat . Results : Of the 388 enrolled women , 381 ( 98.2 % ) had final outcome information . In the SMS group , 38 of 194 ( 19.6 % ) women attended a maternal postpartum clinic compared to 22 of 187 ( 11.8 % ) in the control group ( relative risk 1.66 , 95 % confidence interval 1.02–2.70 ) . HIV testing within 8 weeks was performed in 172 of 187 ( 92.0 % ) infants in the SMS group compared to 154 of 181 ( 85.1 % ) in the control group ( relative risk 1.08 , 95 % confidence interval 1.00–1.16 ) . Conclusions : Text messaging significantly improved maternal postpartum visit attendance , but overall return rates for these visits remained low . In contrast , high rates of early infant HIV testing were achieved in both arms , with significantly higher testing rates in the SMS compared to the control infants BACKGROUND Missed scheduled HIV appointments lead to increased mortality , resistance to antiretroviral therapy , and suboptimum virological response . We aim ed to assess whether reminders sent to carers by text message , mobile phone call , or concomitant text message and mobile phone call increase attendance at medical appointments for HIV care in a population of children infected with or exposed to HIV in Cameroon . We also aim ed to ascertain the most cost-effective method of mobile-phone-based reminder . METHODS MORE CARE was a multicentre , single-blind , factorial , r and omised controlled trial in urban , semi-urban , and rural setting s in Cameroon . Carers of children who were infected with or had been exposed to HIV were r and omly assigned electronically in blocks of four and allocated ( 1:1:1:1 ) sequentially to receive a text message and a call , a text message only , a call only , or no reminder ( control ) . Investigators were masked to group assignment . Text messages were sent and calls made 2 or 3 days before a scheduled follow-up appointment . The primary outcomes were efficacy ( the proportion of patients attending a previously scheduled appointment ) and efficiency ( attendance/ [ measures of staff working time × cost of the reminders ] ) , as a measure of cost-effectiveness . The primary analysis was by intention to treat . This study is registered with the Pan African Clinical Trials Register , number PACTR201304000528276 . FINDINGS The study took place between Jan 28 and May 24 , 2013 . We r and omly assigned 242 adult-child ( carer-patient ) pairs into four groups : text message plus call ( n=61 ) , call ( n=60 ) , text message ( n=60 ) , and control ( n=61 ) . 54 participants ( 89 % ) in the text message plus call group , 51 ( 85 % ) in the call group , 45 ( 75 % ) in the text message group , and 31 ( 51 % ) in the control group attended their scheduled appointment . Compared with control , the odds ratios for improvement in the primary efficacy outcome were 7·5 ( 95 % CI 2·9 - 19·0 ; p<0·0001 ) for text message plus call , 5·5 ( 2·3 - 13·1 ; p=0·0002 ) for call , and 2·9 ( 1·3 - 6·3 ; p=0·012 ) for text message . No significant differences were seen in comparisons of the three intervention groups with each other , and there was no synergism between text messages and calls . For the primary efficiency outcome , the mean difference for text message versus text message plus call was 1·5 ( 95 % CI 0·7 to 2·4 ; p=0·002 ) , for call versus text message plus call was 1·2 ( 0·7 to 1·6 ; p<0·0001 ) , and for call versus text message was 0·4 ( -1·3 to 0·6 ; p=0·47 ) . INTERPRETATION Mobile-phone-based reminders of scheduled HIV appointments for carers of paediatric patients in low-re source setting s can increase attendance . The most effective method of reminder was text message plus phone call , but text messaging alone was the \n Output:\n " }, { "from": "agent", "value": "mHealth communication influenced mothers ’ intentions , skills , and environmental constraints associated with uptake of PNC .\nIntentions were influenced by attitudes , perceived norms and self-efficacy .\nPositive attitudes , as well as changed attitudes toward PNC practice s were observed .\nPerceived norms that were enhanced were delivery at a health facility with immediate PNC , seeking of reinforcement and professional health support of newborn care practice s , and male partner support .\nImproved self-efficacy was demonstrated by mothers who attended scheduled appointments and they were confident with regard to newborn care practice s. Skills for PNC that were improved included cord care , thermal care , appropriate breastfeeding and problem-solving .\nThe environmental constraints faced and which were addressed in the studies included inaccessibility , unavailability and unaffordability of PNC services in rural areas .\nConclusions Results from the literature included in this study show that one-way mobile phone messaging is the common type of mHealth communication used to strengthen PNC in rural areas .\nmHealth communication can influence intentions , skills and environmental constraints as determinants of PNC uptake ." } ]

[ { "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 Few studies have directly compared the renoprotective effects of angiotensin II-receptor blockers and angiotensin-converting-enzyme ( ACE ) inhibitors in persons with type 2 diabetes . METHODS In this prospect i ve , multicenter , double-blind , five-year study , we r and omly assigned 250 subjects with type 2 diabetes and early nephropathy to receive either the angiotensin II-receptor blocker telmisartan ( 80 mg daily , in 120 subjects ) or the ACE inhibitor enalapril ( 20 mg daily , in 130 subjects ) . The primary end point was the change in the glomerular filtration rate ( determined by measuring the plasma clearance of iohexol ) between the baseline value and the last available value during the five-year treatment period . Secondary end points included the annual changes in the glomerular filtration rate , serum creatinine level , urinary albumin excretion , and blood pressure ; the rates of end-stage renal disease and cardiovascular events ; and the rate of death from all causes . RESULTS After five years , the change in the glomerular filtration rate was -17.5 ml per minute per 1.73 m2 ( where the minus sign denotes a decrement ) in the telmisartan-treated subjects , as compared with -15.0 ml per minute per 1.73 m2 in the enalapril-treated subjects ; the treatment difference was thus -2.6 ml per minute per 1.73 m2 ( 95 percent confidence interval , -7.1 to 2.0 ml per minute per 1.73 m2)[corrected ] The lower boundary of the confidence interval , in favor of enalapril , was greater than the predefined margin of -10.0 ml per minute per 1.73 m2 , indicating that telmisartan was not inferior to enalapril . The effects of the two agents on the secondary end points were not significantly different after five years . CONCLUSIONS Telmisartan is not inferior to enalapril in providing long-term renoprotection in persons with type 2 diabetes . These findings do not necessarily apply to persons with more advanced nephropathy , but they support the clinical equivalence of angiotensin II-receptor blockers and ACE inhibitors in persons with conditions that place them at high risk for cardiovascular events Background —Microalbuminuria is associated with increased risk of cardiovascular events . We assessed whether therapeutic intervention aim ed at lowering urinary albumin excretion would reduce cardiovascular events in microalbuminuric subjects ( 15 to 300 mg/24 hours ) . Methods and Results —From the Prevention of Renal and Vascular Endstage Disease ( PREVEND ) cohort ( n=8592 ) , 1439 subjects fulfilled the inclusion criteria of the PREVEND Intervention Trial ( PREVEND IT ) . Of these subjects , 864 were r and omized to fosinopril 20 mg or matching placebo and to pravastatin 40 mg or matching placebo . The mean follow-up was 46 months , and the primary end point was cardiovascular mortality and hospitalization for cardiovascular morbidity . Mean age was 51±12 years ; 65 % of subjects were male , and 3.4 % had a previous cardiovascular event . Mean cholesterol level was 5.8±1.0 mmol/L , mean systolic/diastolic blood pressure was 130±18/76±10 mm Hg , and median urinary albumin excretion was 22.8 ( 15.8 to 41.3 ) mg/24 hours . The primary end point occurred in 45 subjects ( 5.2 % ) . Fosinopril reduced urinary albumin excretion by 26 % ( P<0.001 ) . Subjects treated with fosinopril showed a 40 % lower incidence of the primary end point ( hazard ratio 0.60 [ 95 % CI 0.33 to 1.10 ] , P=0.098 , log-rank ) . Pravastatin did not reduce urinary albumin excretion , and subjects treated with pravastatin showed a 13 % lower incidence of the primary end point than subjects in the placebo group ( 0.87 [ 0.49 to 1.57 ] , P=0.649 , log-rank ) . Conclusions —In microalbuminuric subjects , treatment with fosinopril had a significant effect on urinary albumin excretion . In addition , fosinopril treatment was associated with a trend in reducing cardiovascular events . Treatment with pravastatin did not result in a significant reduction in urinary albumin excretion or cardiovascular events BACKGROUND In patients who have vascular disease or high-risk diabetes without heart failure , angiotensin-converting-enzyme ( ACE ) inhibitors reduce mortality and morbidity from cardiovascular causes , but the role of angiotensin-receptor blockers ( ARBs ) in such patients is unknown . We compared the ACE inhibitor ramipril , the ARB telmisartan , and the combination of the two drugs in patients with vascular disease or high-risk diabetes . METHODS After a 3-week , single-blind run-in period , patients underwent double-blind r and omization , with 8576 assigned to receive 10 mg of ramipril per day , 8542 assigned to receive 80 mg of telmisartan per day , and 8502 assigned to receive both drugs ( combination therapy ) . The primary composite outcome was death from cardiovascular causes , myocardial infa rct ion , stroke , or hospitalization for heart failure . RESULTS Mean blood pressure was lower in both the telmisartan group ( a 0.9/0.6 mm Hg greater reduction ) and the combination-therapy group ( a 2.4/1.4 mm Hg greater reduction ) than in the ramipril group . At a median follow-up of 56 months , the primary outcome had occurred in 1412 patients in the ramipril group ( 16.5 % ) , as compared with 1423 patients in the telmisartan group ( 16.7 % ; relative risk , 1.01 ; 95 % confidence interval [ CI ] , 0.94 to 1.09 ) . As compared with the ramipril group , the telmisartan group had lower rates of cough ( 1.1 % vs. 4.2 % , P<0.001 ) and angioedema ( 0.1 % vs. 0.3 % , P=0.01 ) and a higher rate of hypotensive symptoms ( 2.6 % vs. 1.7 % , P<0.001 ) ; the rate of syncope was the same in the two groups ( 0.2 % ) . In the combination-therapy group , the primary outcome occurred in 1386 patients ( 16.3 % ; relative risk , 0.99 ; 95 % CI , 0.92 to 1.07 ) ; as compared with the ramipril group , there was an increased risk of hypotensive symptoms ( 4.8 % vs. 1.7 % , P<0.001 ) , syncope ( 0.3 % vs. 0.2 % , P=0.03 ) , and renal dysfunction ( 13.5 % vs. 10.2 % , P<0.001 ) . CONCLUSIONS Telmisartan was equivalent to ramipril in patients with vascular disease or high-risk diabetes and was associated with less angioedema . The combination of the two drugs was associated with more adverse events without an increase in benefit . ( Clinical Trials.gov number , NCT00153101 [ Clinical Trials.gov ] . ) OBJECTIVE ACE inhibitors and calcium antagonists may favorably affect serum lipids and glucose metabolism . The primary aim of the Fosinopril Versus Amlodipine Cardiovascular Events R and omized Trial ( FACET ) was to compare the effects of fosinopril and amlodipine on serum lipids and diabetes control in NIDDM patients with hypertension . Prospect ively defined cardiovascular events were assessed as secondary outcomes . RESEARCH DESIGN AND METHODS Inclusion criteria included a diagnosis of NIDDM and hypertension ( systolic blood pressure of > 140 mmHg or diastolic blood pressure of > 90 mmHg ) . Exclusion criteria included a history of coronary heart disease or stroke , serum creatinine > 1.5 mg/dl , albuminuria > 40 μg/min , and use of lipid-lowering drugs , aspirin , or antihypertensive agents other than beta-blockers or diuretics . A total of 380 hypertensive diabetics were r and omly assigned to open-label fosinopril ( 20 mg/day ) or amlodipine ( 10 mg/day ) and followed for up to 3.5 years . If blood pressure was not controlled , the other study drug was added . RESULTS Both treatments were effective in lowering blood pressure . At the end of followup , between the two groups there was no significant difference in total serum cholesterol , HDL cholesterol , HbA1c , fasting serum glucose , or plasma insulin . The patients receiving fosinopril had a significantly lower risk of the combined outcome of acute myocardial infa rct ion , stroke , or hospitalized angina than those receiving amlodipine ( 14/189 vs. 27/191 ; hazards ratio = 0.49 , 95 % CI = 0.26–0.95 ) . CONCLUSIONS Fosinopril and amlodipine had similar effects on biochemical measures , but the patients r and omized to fosinopril had a significantly lower risk of major vascular events , compared with the patients r and omized to amlodipine Few data are available to clarify whether changes in albuminuria over time translate to changes in cardiovascular risk . The aim of the present study was to examine whether changes in albuminuria during 4.8 years of antihypertensive treatment were related to changes in risk in 8206 patients with hypertension and left ventricular hypertrophy in the Losartan Intervention For Endpoint reduction in hypertension ( LIFE ) study . Urinary albumin/creatinine ratio ( UACR ) was measured at baseline and annually . Time-varying albuminuria was closely related to risk for the primary composite end point ( ie , when UACR decreased during treatment , risk was reduced accordingly ) . When the population was divided according to median baseline value ( 1.21 mg/mmol ) and median year 1 UACR ( 0.67 mg/mmol ) , risk increased stepwise and significantly for the primary composite end point from those with low baseline/low year 1 ( 5.5 % ) , to low baseline/high year 1 ( 8.6 % ) , to high baseline/low year 1 ( 9.4 % ) , and to high baseline/high year 1 ( 13.5 % ) values . Similar significant , stepwise increases in risk were seen for the components of the primary composite end point ( cardiovascular mortality , stroke , and myocardial infa rct ion ) . The observation that changes in UACR during antihypertensive treatment over time translated to changes in risk for cardiovascular morbidity and mortality was not explained by in-treatment level of blood pressure . We propose that monitoring of albuminuria should be an integrated part of the management of hypertension . If albuminuria is not decreased by the patient ’s current antihypertensive and other treatment , further intervention directed toward blood pressure control and other modifiable risks should be considered Background The R and omized Olmesartan and Diabetes Microalbuminuria Prevention ( ROADMAP ) study showed that 40 mg Olmesartan medoxomil ( OM ) versus placebo delayed microalbuminuria onset in patients with type 2 diabetes and normoalbuminuria . Methods and Results One thous and seven hundred and fifty‐eight ROADMAP patients ( placebo arm : 877 ; OM arm : 881 ) participated in the observational follow up ( OFU ) with an average of 3.3 years . They received st and ard medical care and micro‐ and macrovascular events were documented . During observational follow‐up 62.9 % and 60.1 % in the former OM and placebo group , respectively , received treatment with a RAS blocking agent . During the OFU period the systolic blood pressure ( SBP ) increased to mean values of 135 mm Hg in both groups . Patients who had developed microalbuminuria during ROADMAP had a higher incidence of cardio‐ and cerebrovascular events ( OR 1.77 , CI 1.03 to 3.03 , P=0.039 ) during the OFU period compared with patients in whom this was not the case . Diabetic retinopathy was significantly reduced in the former OM group ( 8 [ 0.9 % ] versus 23 [ 2.6 % ] , OR : 0.34 , CI 0.15 to 0.78 , P=0.011 ) and the rate of microalbuminuria was numerically reduced . Congestive heart failure requiring hospitalization ( 3 [ 0.3 % ] versus 12 [ 1.4 % ] , OR : 0.23 , CI 0.06 to 0.85 , P=0.027 ) was reduced and there was a trend of reduced cardio‐/cerebrovascular events ( OM versus Pb : 73 [ 8.3 % ] versus 86 [ 9.8 % ] patients ) . Seven ( 0.8 % ) deaths ( including 2 CV events ) were reported in former placebo patients versus 3 ( 0.3 % ) ( non‐CV events ) in \n Output:\n " }, { "from": "agent", "value": "Reduction in UAE under antihypertensive treatment is associated with reduced risk of clinical cardiovascular events .\nOur findings suggest that UAE changes may represent a valuable intermediate end point for cardiovascular events in primary hypertension" } ]

[ { "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 worldwide explosive increase in type 2 diabetes mellitus and its cardiovascular morbidity are becoming major health concerns . OBJECTIVE To evaluate the effect of decreasing postpr and ial hyperglycemia with acarbose , an alpha-glucosidase inhibitor , on the risk of cardiovascular disease and hypertension in patients with impaired glucose tolerance ( IGT ) . DESIGN , SETTING , AND PARTICIPANTS International , multicenter double-blind , placebo-controlled , r and omized trial , undertaken in hospitals in Canada , Germany , Austria , Norway , Denmark , Sweden , Finl and , Israel , and Spain from July 1998 through August 2001 . A total of 1429 patients with IGT were r and omized with 61 patients ( 4 % ) excluded because they did not have IGT or had no postr and omization data , leaving 1368 patients for a modified intent-to-treat analysis . Both men ( 49 % ) and women ( 51 % ) participated with a mean ( SD ) age of 54.5 ( 7.9 ) years and body mass index of 30.9 ( 4.2 ) . These patients were followed up for a mean ( SD ) of 3.3 ( 1.2 ) years . INTERVENTION Patients with IGT were r and omized to receive either placebo ( n = 715 ) or 100 mg of acarbose 3 times a day ( n = 714 ) . MAIN OUTCOME MEASURES The development of major cardiovascular events ( coronary heart disease , cardiovascular death , congestive heart failure , cerebrovascular event , and peripheral vascular disease ) and hypertension ( > or = 140/90 mm Hg ) . RESULTS Three hundred forty-one patients ( 24 % ) discontinued their participation prematurely , 211 in the acarbose-treated group and 130 in the placebo group ; these patients were also followed up for outcome parameters . Decreasing postpr and ial hyperglycemia with acarbose was associated with a 49 % relative risk reduction in the development of cardiovascular events ( hazard ratio [ HR ] , 0.51 ; 95 % confidence interval [ CI ] ; 0.28 - 0.95 ; P = .03 ) and a 2.5 % absolute risk reduction . Among cardiovascular events , the major reduction was in the risk of myocardial infa rct ion ( HR , 0.09 ; 95 % CI , 0.01 - 0.72 ; P = .02 ) . Acarbose was also associated with a 34 % relative risk reduction in the incidence of new cases of hypertension ( HR , 0.66 ; 95 % CI , 0.49 - 0.89 ; P = .006 ) and a 5.3 % absolute risk reduction . Even after adjusting for major risk factors , the reduction in the risk of cardiovascular events ( HR , 0.47 ; 95 % CI , 0.24 - 0.90 ; P = .02 ) and hypertension ( HR , 0.62 ; 95 % CI , 0.45 - 0.86 ; P = .004 ) associated with acarbose treatment was still statistically significant . CONCLUSION This study suggests that treating IGT patients with acarbose is associated with a significant reduction in the risk of cardiovascular disease and hypertension BACKGROUND Improved blood-glucose control decreases the progression of diabetic microvascular disease , but the effect on macrovascular complications is unknown . There is concern that sulphonylureas may increase cardiovascular mortality in patients with type 2 diabetes and that high insulin concentrations may enhance atheroma formation . We compared the effects of intensive blood-glucose control with either sulphonylurea or insulin and conventional treatment on the risk of microvascular and macrovascular complications in patients with type 2 diabetes in a r and omised controlled trial . METHODS 3867 newly diagnosed patients with type 2 diabetes , median age 54 years ( IQR 48 - 60 years ) , who after 3 months ' diet treatment had a mean of two fasting plasma glucose ( FPG ) concentrations of 6.1 - 15.0 mmol/L were r and omly assigned intensive policy with a sulphonylurea ( chlorpropamide , glibenclamide , or glipizide ) or with insulin , or conventional policy with diet . The aim in the intensive group was FPG less than 6 mmol/L. In the conventional group , the aim was the best achievable FPG with diet alone ; drugs were added only if there were hyperglycaemic symptoms or FPG greater than 15 mmol/L. Three aggregate endpoints were used to assess differences between conventional and intensive treatment : any diabetes-related endpoint ( sudden death , death from hyperglycaemia or hypoglycaemia , fatal or non-fatal myocardial infa rct ion , angina , heart failure , stroke , renal failure , amputation [ of at least one digit ] , vitreous haemorrhage , retinopathy requiring photocoagulation , blindness in one eye , or cataract extraction ) ; diabetes-related death ( death from myocardial infa rct ion , stroke , peripheral vascular disease , renal disease , hyperglycaemia or hypoglycaemia , and sudden death ) ; all-cause mortality . Single clinical endpoints and surrogate sub clinical endpoints were also assessed . All analyses were by intention to treat and frequency of hypoglycaemia was also analysed by actual therapy . FINDINGS Over 10 years , haemoglobin A1c ( HbA1c ) was 7.0 % ( 6.2 - 8.2 ) in the intensive group compared with 7.9 % ( 6.9 - 8.8 ) in the conventional group -- an 11 % reduction . There was no difference in HbA1c among agents in the intensive group . Compared with the conventional group , the risk in the intensive group was 12 % lower ( 95 % CI 1 - 21 , p=0.029 ) for any diabetes-related endpoint ; 10 % lower ( -11 to 27 , p=0.34 ) for any diabetes-related death ; and 6 % lower ( -10 to 20 , p=0.44 ) for all-cause mortality . Most of the risk reduction in the any diabetes-related aggregate endpoint was due to a 25 % risk reduction ( 7 - 40 , p=0.0099 ) in microvascular endpoints , including the need for retinal photocoagulation . There was no difference for any of the three aggregate endpoints between the three intensive agents ( chlorpropamide , glibenclamide , or insulin ) . Patients in the intensive group had more hypoglycaemic episodes than those in the conventional group on both types of analysis ( both p<0.0001 ) . The rates of major hypoglycaemic episodes per year were 0.7 % with conventional treatment , 1.0 % with chlorpropamide , 1.4 % with glibenclamide , and 1.8 % with insulin . Weight gain was significantly higher in the intensive group ( mean 2.9 kg ) than in the conventional group ( p<0.001 ) , and patients assigned insulin had a greater gain in weight ( 4.0 kg ) than those assigned chlorpropamide ( 2.6 kg ) or glibenclamide ( 1.7 kg ) . INTERPRETATION Intensive blood-glucose control by either sulphonylureas or insulin substantially decreases the risk of microvascular complications , but not macrovascular disease , in patients with type 2 diabetes . ( ABSTRACT TRUNCATED Background —Postpr and ial hyperglycemia may be a risk factor for cardiovascular disease . We compared the effects of two insulin secretagogues , repaglinide and glyburide , known to have different efficacy on postpr and ial hyperglycemia , on carotid intima-media thickness ( CIMT ) and markers of systemic vascular inflammation in type 2 diabetic patients . Methods and Results —We performed a r and omized , single-blind trial on 175 drug-naive patients with type 2 diabetes mellitus ( 93 men and 82 women ) , 35 to 70 years of age , selected from a population of 401 patients who participated in an epidemiological analysis assessing the relation of postpr and ial hyperglycemia to surrogate measures of atherosclerosis . Eighty-eight patients were r and omly assigned to receive repaglinide and 87 patients to glyburide , with a titration period of 6 to 8 weeks for optimization of drug dosage and a subsequent 12-month treatment period . The effects of repaglinide ( 1.5 to 12 mg/d ) and glyburide ( 5 to 20 mg/d ) on CIMT were compared by using blinded , serial assessment s of the far wall . After 12 months , postpr and ial glucose peak was 148±28 mg/dL in the repaglinide group and 180±32 mg/dL in the glyburide group ( P < 0.01 ) . HbA1c showed a similar decrease in both groups ( −0.9 % ) . CIMT regression , defined as a decrease of > 0.020 mm , was observed in 52 % of diabetics receiving repaglinide and in 18 % of those receiving glyburide ( P < 0.01 ) . Interleukin-6 ( P = 0.04 ) and C-reactive protein ( P = 0.02 ) decreased more in the repaglinide group than in the glyburide group . The reduction in CIMT was associated with changes in postpr and ial but not fasting hyperglycemia . Conclusions —Reduction of postpr and ial hyperglycemia in type 2 diabetic patients is associated with CIMT regression BACKGROUND New diagnostic criteria for diabetes based on fasting blood glucose ( FBG ) level were approved by the American Diabetes Association . The impact of using FBG only has not been evaluated thoroughly . The fasting and the 2-hour glucose ( 2h-BG ) criteria were compared with regard to the prediction of mortality . METHODS Existing baseline data on glucose level at fasting and 2 hours after a 75-g oral glucose tolerance test from 10 prospect i ve European cohort studies including 15 388 men and 7126 women aged 30 to 89 years , with a median follow-up of 8.8 years , were analyzed . Hazards ratios for death from all causes , cardiovascular disease , coronary heart disease , and stroke were estimated . RESULTS Multivariate Cox regression analyses showed that the inclusion of FBG did not add significant information on the prediction of 2h-BG alone ( P>.10 for various causes ) , whereas the addition of 2h-BG to FBG criteria significantly improved the prediction ( P<.001 for all causes and P<.005 for cardiovascular disease ) . In a model including FBG and 2h-BG simultaneously , hazards ratios ( 95 % confidence intervals ) in subjects with diabetes on 2h-BG were 1.73 ( 1.45 - 2.06 ) for all causes , 1.40 ( 1.02 - 1.92 ) for cardiovascular disease , 1.56 ( 1.03 - 2.36 ) for coronary heart disease , and 1.29 ( 0.66 - 2.54 ) for stroke mortality , compared with the normal 2h-BG group . Compared with the normal FBG group , the corresponding hazards ratios in subjects with diabetes on FBG were 1.21 ( 1.01 - 1.44 ) , 1.20 ( 0.88 - 1.64 ) , 1.09 ( 0.71 - 1.67 ) , and 1.64 ( 0.88 - 3.07 ) , respectively . The largest number of excess deaths was observed in subjects who had impaired glucose tolerance but normal FBG levels . CONCLUSION The 2h-BG is a better predictor of deaths from all causes and cardiovascular disease than is FBG Summary The Diabetes Intervention Study ( DIS ) is a prospect i ve population -based multicentre trial of newly detected cases of non-insulin-dependent diabetes mellitus ( NIDDM ) . This report analyses the risk factors for subsequent coronary heart disease and all-cause death during the 11-year follow-up . The prognostic significance of the categories of the NIDDM Policy Group was vali date d with respect to the incidence of coronary heart disease and mortality . At baseline 1139 subjects , aged 30–55 years at the time of diabetes detection and classified as diet controlled after a 6-week screening phase , were included . Of the patients 112 ( 15.2 % ) suffered from myocardial infa rct ion , 197 ( 19.82 % ) of 994 had died . The odds ratio for all-cause mortality compared to the general population for males at the age of 36–45 years was 5.1 and for females 7.0 . In multivariate analysis age , blood pressure and smoking were independent risk factors for myocardial infa rct ion and male sex , age , blood pressure , triglycerides , postpr and ial blood glucose and smoking for death , respectively . The categories of the NIDDM Policy Group target parameters for blood glucose , triglycerides and blood pressure were significant predictors of both CHD and death . Thus , it appears \n Output:\n " }, { "from": "agent", "value": "Despite this , the few available studies show that higher PPG is associated with increased all-cause and cardiovascular death , incidence of major cardiovascular events ( including myocardial infa rct ion and stroke ) , and progression of diabetic retinopathy" } ]

[ { "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: Fear of losing one 's cognitive ability to Alzheimer disease and related dementias ( ADRD ) and ultimately declining to a state considered by many to be worse than death ( 1 ) is driving a growing brain-training industry . Cognitive training programs , marketed to otherwise healthy adults and persons with a recent diagnosis of mild cognitive impairment ( MCI ) , make bold cl aims for reversing brain aging . Such cl aims include the ability to boost cognitive reserve in midlife ( with cognitive reserve referring to both the mismatch between clinical symptoms of dementia and pathologic brain lesion load at death and the repeatedly demonstrated association between educational achievement and dementia risk ) . However , few studies have evaluated the effect of cognitive training programs on cognitive decline or the onset of dementia , which is the outcome of interest for most people who buy these programs . This review systematic ally evaluates the existing literature on the effectiveness of cognitive training in preventing cognitive decline and ADRD . It is part of a larger systematic review commissioned by the National Institute on Aging to address a range of potential interventions to slow cognitive decline and prevent or delay dementia . Methods We developed and followed a st and ard protocol that was posted on the Agency for Healthcare Research and Quality ( AHRQ ) Web site ( www.effectivehealthcare.ahrq.gov ) . Full details of the methods , including literature search es , findings , and evidence tables , are available in the final report ( 2 ) . Data Sources and Search es We search ed Ovid MEDLINE , PsycINFO , EMBASE , and the Cochrane Central Register of Controlled Trials for relevant literature published between January 2009 and July 2017 ( see Part A of the Supplement , for search es ) and h and - search ed reference lists of selected articles . We identified studies published before 2009 by review ing studies included and excluded from the 2010 AHRQ review on preventing Alzheimer disease and cognitive decline ( 3 ) . Supplement . Cognitive Training Supplement Study Selection Two investigators independently review ed titles and abstract s of search results and screened the full text of potentially eligible references . We included r and omized trials of cognitive training interventions enrolling adults with either normal cognition or MCI if the studies followed participants for at least 6 months , provided cognitive performance or incident dementia outcomes , and were published in English . We excluded studies that enrolled only persons diagnosed with dementia . The final health outcome of interest was incident ADRD . Intermediate health outcomes of interest included performance on cognitive testing , biomarker protein levels , brain matter volume , and brain cell activity level . No restrictions were placed on sample size or comparator type . Data Extraction and Quality Assessment One review er extracted study , population , intervention , comparator , and setting characteristics as well as the funding source from all eligible studies . Risk of bias was assessed independently from full texts by 2 investigators using an instrument based on AHRQ guidance ( 4 ) . Risk of bias was individually review ed overall and for each outcome and time point , and was summarized as low , medium , or high on the basis of a summary of bias risk across risk-of-bias domains and confidence that results were credible given the study 's limitations . Outcomes and adverse events were extracted from studies with low to medium risk of bias . A second review er checked the quality of all data . Data Synthesis and Analysis Only studies with low or medium risk of bias were summarized , because we judged findings from studies with high risk of bias to lack validity , have little meaning , or be easily misinterpreted . Because studies used a highly varied set of outcome measures , neuropsychological tests were categorized by the following specific cognitive domains to facilitate analysis : executive function , attention , and processing speed ; memory ; language ; and visuospatial abilities ( Supplement Table A1 ) . The domains of executive function , attention , and processing speed were grouped together because cognitive tests frequently measure all 3 of these related domains . Because studies analyzed and reported cognitive test results in many different ways , making it difficult or impossible to determine effect size or to assess whether between-group differences in scores or subscores were clinical ly meaningful ( Supplement Table A2 ) , we analyzed and reported cognitive test results by direction of effect and statistical significance . When we identified at least 2 studies or 1 large study ( > 500 participants ) for a treatment comparison , 2 review ers grade d strength of evidence for each outcome on the basis of study limitations , directness , consistency , and precision ; otherwise , strength of evidence was grade d as insufficient . Assessment s were confirmed by consensus . Role of the Funding Source The National Institute on Aging of the National Institutes of Health requested this report from the AHRQ Evidence -based Practice Center Program . The funding agencies provided comments on draft reports but had no role in data collection , analysis , interpretation , or manuscript development . Results We identified 35 publications of 34 unique r and omized controlled trials of cognitive training interventions , 11 of which had medium or low risk of bias ( 516 ) . Only 1 trial was industry funded ( 8) , whereas in 3 cases , trial funding was not reported ( 9 , 15 , 16 ) . ( See the Supplement Figure and Supplement Tables C1 to C4 for the literature flow diagram , evidence tables , and risk-of-bias assessment s. ) The Table summarizes the overall strength-of- evidence findings . For cognitively normal adults , moderate-strength evidence suggests that cognitive training in a particular domain improves performance in that domain compared with inactive or attention control population s. These results are driven largely by the results from the ACTIVE ( Advanced Cognitive Training for Independent and Vital Elderly ) trial . Low-strength evidence suggests that for persons with MCI , cognitive training in a particular domain does not improve performance in that domain compared with controls . The MCI trials have more limitations and are less precise than the studies conducted with cognitively normal participants . Evidence is insufficient for incident MCI or ADRD outcomes . Table . Summary of Conclusions and Strength of Evidence for Cognitive Training in Adults With Normal Cognition or MCI * Studies in Cognitively Normal Population s Six trials with low to medium risk of bias tested training interventions in cognitively normal older adults ( 510 ) . Sample sizes for the selected studies ranged from 40 to 2832 participants . Interventions lasted from 2 weeks to 6 months ; follow-up ranged from 6 months to 2 years . Three of the 6 trials used only computer-based interventions ( 68 ) , 2 used a combination of computer and noncomputer ( paper- and -pencil ) interventions ( 5 , 9 ) , and 1 used group-based competition to increase divergent thinking ( 10 ) . Three of the computer-based interventions were design ed to increase performance on a specific cognitive domain ( such as processing speed ) ( 5 , 6 , 9 ) , 1 used computers for cognitive stimulation more generally ( 7 ) , and 1 used a computer program design ed to train several cognitive domains ( 8) . Comparators included both inactive ( 5 , 7 , 8 , 10 ) and attention controls ( 6 , 9 ) . No studies reported adverse effects . The largest trial of cognitive training , ACTIVE , r and omly assigned 2832 older adults ( mean age , 74 years ) without clinical ly significant cognitive impairment to 1 of 3 training groups or a no-contact control group ( 5 ) . In each training group , a different cognitive domain was targeted : memory , reasoning , or processing speed . Participants in the intervention groups received 10 trainings of 60 to 70 minutes over 6 weeks . Cognitive testing outcomes included measuring changes in domain-specific test performance . Patient-centered cognitive outcomes included measuring changes in everyday problem solving ( such as the ability to identify information on medication bottles ) , everyday speed ( such as the time required to find food items on a grocery shelf ) , driving , and degree of dependency in completing activities of daily living and instrumental activities of daily living . Incident MCI or ADRD was not a prespecified outcome . Although 5- and 10-year outcomes from the ACTIVE trial have been published ( 17 , 18 ) , only the results from the 2-year study had a medium risk of bias ( 5 ) . At 2 years , ACTIVE participants showed improvement in the cognitive domains in which they were trained ( for example , those who received memory training improved on memory-related tasks compared with control participants ) , but no statistically significant differences were found among groups with regard to other cognitive outcomes ( for example , persons who received training in memory did not do better than control participants on reasoning tasks ) . Intervention and control groups did not differ in other patient-centered cognitive outcomes at 2-year follow-up . Modeled on the visual process and speed training group of the ACTIVE trial , IHAMS ( the Iowa Healthy and Active Minds Study ) ( n= 681 ) ( 6 ) r and omly assigned adults by age group ( 50 to 64 years vs. 65 years ) to visual processing speed training at the study center , visual processing speed training on the participant 's home computer , or computerized crossword puzzles ( attention control group ) . Two-hour training sessions were held once a week for 5 weeks . Participants assigned to the intervention at the training center also received a booster training at 11 months . One year after training , both intervention groups showed statistically significant improvement in the primary outcome of the Useful Field of View test compared with the attention control group . The IHAMS participants also were administered 8 secondary cognitive tests on which they had not been Importance Oxidative stress is an established dementia pathway , but it is unknown if the use of antioxidant supplements can prevent dementia . Objective To determine if antioxidant supplements ( vitamin E or selenium ) used alone or in combination can prevent dementia in asymptomatic older men . Design , Setting , and Participants The Prevention of Alzheimer ’s Disease by Vitamin E and Selenium ( PREADViSE ) trial began as a double-blind r and omized clinical trial in May 2002 , which transformed into a cohort study from September 2009 to May 2015 . The PREADViSE trial was ancillary to the Selenium and Vitamin E Cancer Prevention Trial ( SELECT ) , a r and omized clinical trial of the same antioxidant supplements for preventing prostate cancer , which closed in 2009 owing to findings from a futility analysis . The PREADViSE trial recruited 7540 men , of whom 3786 continued into the cohort study . Participants were at least 60 years old at study entry and were enrolled at 130 SELECT sites , and Cox proportional hazards models were used in a modified intent-to-treat analysis to compare hazard rates among the study arms . Interventions Participants were r and omized to vitamin E , selenium , vitamin E and selenium , or placebo . While taking study supplements , enrolled men visited their SELECT site and were evaluated for dementia using a 2-stage screen . During the cohort study , men were contacted by telephone and assessed using an enhanced 2-stage cognitive screen . In both phases , men were encouraged to visit their physician if the screen results indicated possible cognitive impairment . Main Outcomes and Measures Dementia case ascertainment relied on a consensus review of the cognitive screens and medical records for men with suspected dementia who visited their physician for an evaluation or by review of all available information , including a functional assessment screen . Results The mean ( SD ) baseline age of the 7540 participants was 67.5 ( 5.3 ) years , with 3936 ( 52.2 % ) reporting a college education or better , 754 ( 10.0 % ) reporting black race , and 505 ( 6.7 % ) reporting Hispanic ethnicity . Dementia incidence ( 325 of 7338 men [ 4.4 % ] ) was not different among the 4 study arms . A Cox model , which adjusted incidence for participant demographic information and baseline self-reported comorbidities , yielded hazard ratios of 0.88 ( 95 % CI , 0.64 - 1.20 ) for vitamin E , 0.83 ( 0.60 - 1.13 ) for selenium , and 1.00 ( 0.75 - 1.35 ) for the combination compared with placebo . Conclusions and Relevance Neither supplement prevented dementia . To our knowledge , this is the first study to investigate the long-term association of antioxidant supplement use and dementia incidence among asymptomatic men Introduction Cognitive training improves cognitive performance and delays functional impairment , but its effects on dementia are not known . We examined whether three different types of cognitive training lowered the risk of dementia across 10 years of follow-up relative to control and if greater number of training sessions attended was associated with lower dementia risk . Methods The Advanced Cognitive Training in Vital Elderly ( NCT00298558 ) study was a r and omized controlled trial ( N = 2802 ) among initially healthy older adults , which examined the efficacy of three cognitive training programs ( memory , reasoning , or speed of processing ) relative to a no-contact control condition . Up to 10 training sessions were delivered over 6 weeks with up to four sessions of booster training delivered at 11 months and a second set of up to four booster sessions at 35 months . Outcome assessment s were taken immediately after intervention and at intervals over 10 years . Dementia was defined using a combination of interview- and performance-based methods . Results A total of 260 cases of dementia were identified during the follow-up . Speed training result ed in reduced risk of dementia ( hazard ratio [ HR ] 0.71 , 95 % confidence interval [ CI ] 0.50–0.998 , P = .049 ) compared to control , but memory and reasoning training did not ( HR 0.79 , 95 % CI 0.57–1.11 , P = .177 and HR 0.79 , 95 % CI 0.56–1.10 , P = .163 , respectively ) . Each additional speed training session was associated with a 10 % lower hazard for dementia ( unadjusted HR , 0. \n Output:\n " }, { "from": "agent", "value": "In conclusion , nonpharmacological therapy could have an indicative role in reducing the case of MCI or 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: Introduction Acute hemodynamic instability increases morbidity and mortality . We investigated whether early non-invasive cardiac output monitoring enhances hemodynamic stabilization and improves outcome . Methods A multicenter , r and omized controlled trial was conducted in three European university hospital intensive care units in 2006 and 2007 . A total of 388 hemodynamically unstable patients identified during their first six hours in the intensive care unit ( ICU ) were r and omized to receive either non-invasive cardiac output monitoring for 24 hrs ( minimally invasive cardiac output/MICO group ; n = 201 ) or usual care ( control group ; n = 187 ) . The main outcome measure was the proportion of patients achieving hemodynamic stability within six hours of starting the study . Results The number of hemodynamic instability criteria at baseline ( MICO group mean 2.0 ( SD 1.0 ) , control group 1.8 ( 1.0 ) ; P = .06 ) and severity of illness ( SAPS II score ; MICO group 48 ( 18 ) , control group 48 ( 15 ) ; P = .86 ) ) were similar . At 6 hrs , 45 patients ( 22 % ) in the MICO group and 52 patients ( 28 % ) in the control group were hemodynamically stable ( mean difference 5 % ; 95 % confidence interval of the difference -3 to 14 % ; P = .24 ) . Hemodynamic support with fluids and vasoactive drugs , and pulmonary artery catheter use ( MICO group : 19 % , control group : 26 % ; P = .11 ) were similar in the two groups . The median length of ICU stay was 2.0 ( interquartile range 1.2 to 4.6 ) days in the MICO group and 2.5 ( 1.1 to 5.0 ) days in the control group ( P = .38 ) . The hospital mortality was 26 % in the MICO group and 21 % in the control group ( P = .34 ) . Conclusions Minimally-invasive cardiac output monitoring added to usual care does not facilitate early hemodynamic stabilization in the ICU , nor does it alter the hemodynamic support or outcome . Our results emphasize the need to evaluate technologies used to measure stroke volume and cardiac output -- especially their impact on the process of care -- before any large-scale outcome studies are attempted . Trial Registration The study was registered at Clinical Trials.gov ( Clinical Trials identifier NCT00354211 CONTEXT Previous studies indicate that industry-sponsored trials tend to draw proindustry conclusions . OBJECTIVE To explore whether the association between funding and conclusions in r and omized drug trials reflects treatment effects or adverse events . DESIGN Observational study of 370 r and omized drug trials included in meta-analyses from Cochrane review s selected from the Cochrane Library , May 2001 . From a r and om sample of 167 Cochrane review s , 25 contained eligible meta-analyses ( assessed a binary outcome ; pooled at least 5 full-paper trials of which at least 1 reported adequate and 1 reported inadequate allocation concealment ) . The primary binary outcome from each meta- analysis was considered the primary outcome for all trials included in each meta- analysis . The association between funding and conclusions was analyzed by logistic regression with adjustment for treatment effect , adverse events , and additional confounding factors ( method ological quality , control intervention , sample size , publication year , and place of publication ) . MAIN OUTCOME MEASURE Conclusions in trials , classified into whether the experimental drug was recommended as the treatment of choice or not . RESULTS The experimental drug was recommended as treatment of choice in 16 % of trials funded by nonprofit organizations , 30 % of trials not reporting funding , 35 % of trials funded by both nonprofit and for-profit organizations , and 51 % of trials funded by for-profit organizations ( P<.001 ; chi2 test ) . Logistic regression analyses indicated that funding , treatment effect , and double blinding were the only significant predictors of conclusions . Adjusted analyses showed that trials funded by for-profit organizations were significantly more likely to recommend the experimental drug as treatment of choice ( odds ratio , 5.3 ; 95 % confidence interval , 2.0 - 14.4 ) compared with trials funded by nonprofit organizations . This association did not appear to reflect treatment effect or adverse events . CONCLUSIONS Conclusions in trials funded by for-profit organizations may be more positive due to biased interpretation of trial results . Readers should carefully evaluate whether conclusions in r and omized trials are supported by data BACKGROUND Some observational studies suggest that the use of pulmonary-artery catheters to guide therapy is associated with increased mortality . METHODS We performed a r and omized trial comparing goal -directed therapy guided by a pulmonary-artery catheter with st and ard care without the use of a pulmonary-artery catheter . The subjects were high-risk patients 60 years of age or older , with American Society of Anesthesiologists ( ASA ) class III or IV risk , who were scheduled for urgent or elective major surgery , followed by a stay in an intensive care unit . Outcomes were adjudicated by observers who were unaware of the treatment-group assignments . The primary outcome was in-hospital mortality from any cause . RESULTS Of 3803 eligible patients , 1994 ( 52.4 percent ) underwent r and omization . The base-line characteristics of the two treatment groups were similar . A total of 77 of 997 patients who underwent surgery without the use of a pulmonary-artery catheter ( 7.7 percent ) died in the hospital , as compared with 78 of 997 patients in whom a pulmonary-artery catheter was used ( 7.8 percent)--a difference of 0.1 percentage point ( 95 percent confidence interval , -2.3 to 2.5 ) . There was a higher rate of pulmonary embolism in the catheter group than in the st and ard-care group ( 8 events vs. 0 events , P=0.004 ) . The survival rates at 6 months among patients in the st and ard-care and catheter groups were 88.1 and 87.4 percent , respectively ( difference , -0.7 percentage point [ 95 percent confidence interval , -3.6 to 2.2 ] ; negative survival differences favor st and ard care ) ; at 12 months , the rates were 83.9 and 83.0 percent , respectively ( difference , -0.9 percentage point [ 95 percent confidence interval , -4.3 to 2.4 ] ) . The median hospital stay was 10 days in each group . CONCLUSIONS We found no benefit to therapy directed by pulmonary-artery catheter over st and ard care in elderly , high-risk surgical patients requiring intensive care Introduction Several studies have shown that goal -directed hemodynamic and fluid optimization may result in improved outcome . However , the methods used were either invasive or had other limitations . The aim of this study was to perform intraoperative goal -directed therapy with a minimally invasive , easy to use device ( FloTrac/Vigileo ) , and to evaluate possible improvements in patient outcome determined by the duration of hospital stay and the incidence of complications compared to a st and ard management protocol . Methods In this r and omized , controlled trial 60 high-risk patients scheduled for major abdominal surgery were included . Patients were allocated into either an enhanced hemodynamic monitoring group using a cardiac index based intraoperative optimization protocol ( FloTrac/Vigileo device , GDT-group , n = 30 ) or a st and ard management group ( Control-group , n = 30 ) , based on st and ard monitoring data . Results The median duration of hospital stay was significantly reduced in the GDT-group with 15 ( 12 - 17.75 ) days versus 19 ( 14 - 23.5 ) days ( P = 0.006 ) and fewer patients developed complications than in the Control-group [ 6 patients ( 20 % ) versus 15 patients ( 50 % ) , P = 0.03 ] . The total number of complications was reduced in the GDT-group ( 17 versus 49 complications , P = 0.001 ) . Conclusions In high-risk patients undergoing major abdominal surgery , implementation of an intraoperative goal -directed hemodynamic optimization protocol using the FloTrac/Vigileo device was associated with a reduced length of hospital stay and a lower incidence of complications compared to a st and ard management protocol .Trial Registration Clinical trial registration information : Unique identifier : The objective was to compare the impact of an early goal -directed hemodynamic therapy based on cardiac output monitoring ( Endotracheal Cardiac Output Monitor , ECOM ) with a st and ard of care on postoperative outcome following coronary surgery . This prospect i ve , controlled , parallel-arm trial r and omized 100 elective primary coronary artery bypass grafting patients to a study group ( ECOM ; n = 50 ) or a control group ( control ; n = 50 ) . In the ECOM group , hemodynamic therapy was guided by respiratory stroke volume variation and cardiac index given by the ECOM system . A st and ard of care was used in the control . Goal -directed therapy was started immediately after induction of anesthesia and continued until arrival in the intensive care unit ( ICU ) . The primary endpoint was the time when patients fulfilled discharge criteria from hospital ( possible hospital discharge ) . Secondary endpoints were the hospital discharge , the time to reach extubation , the length of stay in ICU , the number of major adverse cardiac events , and in-hospital mortality . Patients in the ECOM group received more often fluid loading and dobutamine . The time to reach extubation was reduced in the ECOM group : 510 min [ 360–1,110 ] versus 570 min [ 320–1,520 ] , P = 0.005 . No significant differences were found between both groups for possible hospital discharge [ Hazard Ratio = 0.96 ( 95 % CI 0.64–1.45 ) ] and hospital discharge [ Hazard Ratio = 1.20 ( 95 % CI 0.79–1.81 ) ] . A mini-invasive early goal -directed hemodynamic therapy based on ECOM can reduce the time to reach extubation but fails to significantly reduce the length of stay in hospital and the rate of major cardiac morbidity Background and Aims : Advanced monitoring targeting haemodynamic and oxygenation variables can improve outcomes of surgery in high-risk patients . We aim ed to assess the impact of goal directed therapy ( GDT ) targeting cardiac index ( CI ) and oxygen extraction ratio ( O 2 ER ) on outcomes of high-risk patients undergoing abdominal surgery . Methods : In a prospect i ve r and omised trial , forty patients ( American Society of Anaesthesiologists II and III ) undergoing major abdominal surgeries were r and omised into two groups . In-Group A mean arterial pressure ≥ 65 mmHg , central venous pressure ≥ 8 - 10 mmHg , urine output ≥ 0.5 mL/kg/h and central venous oxygen saturation ≥ 70 % were targeted intra-operatively and 12 h postoperatively . In-Group-B ( enhanced GDT ) , in addition to the monitoring in-Group-A , CI ≥ 2.5 L/min/m 2 and O 2 ER ≤ 27 % were targeted . The end-points were lactate levels and base deficit during and after surgery . The secondary end points were length of Intensive Care Unit ( ICU ) and hospital stay and postoperative complications . Wilcoxon Mann Whitney and Chi-square tests were used for statistical assessment . Results : Lactate levels postoperatively at 4 and 8 h were lower in-Group-B ( P < 0.05 ) . The mean base deficit at 3 , 4 , 5 and 6 h intra-operatively and postoperatively after 4 , 8 and 12 h were lower in-Group-B ( P < 0.05 ) . There were no significant differences in ICU stay ( 2.10 ± 1.52 vs. 2.90 ± 2.51 days ) or hospital stay ( 10.85 + 4.39 vs. 13.35 + 6.77 days ) between Group A and B. Conclusions : Implementation of enhanced GDT targeting CI and OER was associated with improved tissue oxygenation Background Major abdominal surgery is associated with significant risk of morbidity and mortality in the perioperative period . Optimising intraoperative fluid administration may result in improved outcomes . Our aim was to compare the effects of central venous pressure ( CVP ) , and central venous oxygen saturation (ScvO2)-assisted fluid therapy on postoperative complications in patients undergoing high risk surgery . Methods Patients undergoing elective major abdominal surgery were r and omised into control and ScvO2 groups . The target level of mean arterial pressure ( MAP ) was ≥ 60 mmHg in both groups . In cases of MAP < 60 mmHg patients received either a fluid or vasopressor bolus according to the CVP < 8 mmHg in the control group . In the ScvO2 group , in addition to the MAP , an ScvO2 of < 75 % or a > 3 % decrease indicated need for intervention , regardless of the actual MAP . Data are presented as mean ± st and ard deviation or median ( interquartile range ) . Results We observed a lower number of patients with complications in the ScvO2 group compared to the control group , however it did not reach statistical significance ( ScvO2 group : 10 vs. control group : 19 ; p = 0.07 ) . Patients in the ScvO2 group ( n = 3 \n Output:\n " }, { "from": "agent", "value": "No significant effect of GDHT was found on mortality .\nConclusions The available evidence does not suggest a close relationship between COI and study results in GDHT research .\nHowever , a potential association may exist between COI and an article ’s conclusion in GDHT research" } ]

[ { "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 : We evaluated the effectiveness of five training methods -four structured and one unstructured-for teaching intracorporeal knot tying . Methods : Forty-three graduate students without prior laparoscopic experience were r and omly assigned to one of five training groups , and their performance in 10 intracorporeal knot tying trials was evaluated , using time to complete a knot as the outcome measure . Results : The average knot tying times for the four structured groups were significantly faster than the unstructured group ( p < 0.0001 ) . AMONG THE FOUR STRUCTURED GROUPS , THE MINIMALLY INVASIVE SURGICAL TRAINER-VIRTUAL REALITY ( MIST-VR ) AND THE BOX TRAINER DRILLS SHOWED THE MOST RAPID IMPROVEMENTS . THE MIST-VR IMPROVED AVERAGE SUTURING TIME FROM TRIAL ONE TO TRIAL TWO ( P = 0.05 ) , THE BOX TRAINER DRILLS GROUP IMPROVED FROM TRIAL ONE TO TRIAL FOUR ( P = 0.01 ) , AND THE OTHER TWO GROUPS SHOWED SLOWER IMPROVEMENTS . STATISTICALLY SIGNIFICANT CORRELATIONS WERE OBSERVED BETWEEN SCORES ON MIST-VR TASKS AND AVERAGE KNOT TYING TIMES ( R > 0.7 , p < 0.05 ) . Conclusion : Structured training can be useful for the development of laparoscopic skills . MIST-VR is a valuable part of this training , particularly in the objective evaluation of performance Background Laparoscopic suturing is one of the most difficult tasks in endoscopic surgery , requiring extensive training . The aim of this study was to determine the transfer validity of knot-tying training on a virtual-reality ( VR ) simulator to a realistic laparoscopic environment . Methods Twenty surgical trainees underwent basic eye – h and coordination training on a VR simulator ( SIMENDO , DelltaTech , Delft , the Netherl and s ) until predefined performance criteria were met . Then , they were r and omized into two groups . Group A ( the experimental group ) received additional training with the knot-tying module on the simulator , during which they had to tie a double laparoscopic knot ten times . Group B ( controls ) did not receive additional manual training . Within a week the participants tied a double knot in the abdominal cavity of an anaesthetized porcine model . Their performance was captured on digital video and coded . Objective analysis parameters were : time taken to tie the knot and number of predefined errors made . Subjective assessment s were also made by two laparoscopic surgeons using a global rating list with a five-point Likert scale . Results Trainees in group A ( n = 9 ) were significantly faster than the controls ( n = 10 ) , with a median of 262 versus 374 seconds ( p = 0.034 ) . Group A made a significantly lower number of errors than the controls ( median of 24 versus 36 errors , p = 0.030 ) . Subjective assessment s by the laparoscopic experts did not show any significant differences in economy of movement and erroneous behavior between the two groups . ConclusionS urgical trainees who received knot-tying training on the VR simulator were faster and made fewer errors than the controls . The VR module is a useful tool to train laparoscopic knot-tying . Opportunities arose to improve simulator-based instruction that might enhance future training Background : The study aim was to compare the effectiveness of virtual reality and computer-enhanced video-scopic training devices for training novice surgeons in complex laparoscopic skills . Methods : Third-year medical students received instruction on laparoscopic intracorporeal suturing and knot tying and then underwent a pretraining assessment of the task using a live porcine model . Students were then r and omized to objectives -based training on either the virtual reality ( n=8 ) or computer-enhanced ( n=8 ) training devices for 4 weeks , after which the assessment was repeated . Results : Posttraining performance had improved compared with pretraining performance in both task completion rate ( 94 % versus 18 % ; P<0.001 * ) and time [ 181±58 ( SD ) versus 292±24 * ] . Performance of the 2 groups was comparable before and after training . Of the subjects , 88 % thought that haptic cues were important in simulators . Both groups agreed that their respective training systems were effective teaching tools , but computer-enhanced device trainees were more likely to rate their training as representative of reality ( P<0.01 ) . Conclusions : Training on virtual reality and computer-enhanced devices had equivalent effects on skills improvement in novices . Despite the perception that haptic feedback is important in laparoscopic simulation training , its absence in the virtual reality device did not impede acquisition of skill BACKGROUND We hypothesized that the Minimally Invasive Surgery Trainer ( MIST-VR ; VP Medical R , London , U.K. ) would be as effective as the Yale Laparoscopic Skills Course in improving laparoscopic intracorporeal suturing skills . MATERIAL S AND METHODS Each student made six attempts to tie a knot laparoscopically . Students were then r and omized to train on the MIST-VR for five sessions ( six skills/session ) or the Yale Skills for five sessions ( three skills/session ) over 5 days . On completion of training , all students were evaluated by a test consisting of six attempts to tie a laparoscopic knot . RESULTS The percentage improvement in knot tying time did not differ significantly in the pelvic trainer group ( 30 + /- 21 % ) ( from 443 + /- 135 to 311 + /- 137 seconds ) and the MIST-VR group ( 39 + /- 21 % ) ( from 409 + /- 109 to 256 + /- 140 seconds ) ( P = 0.308 ) . CONCLUSIONS The MIST-VR is equivalent to the Yale Skills Course for training in the advanced laparoscopic skill of intracorporeal suturing INTRODUCTION Laparoscopic surgery has become the st and ard of care for many surgical diseases . Haptic ( tactile ) feedback ( HFB ) is considered an important component of laparoscopic surgery . Virtual reality simulation ( VRS ) is an alternative method to teach surgical skills to surgeons in training . Newer VRS trainers such as the Simbionix Lap Mentor II provide significantly improved tactile feedback . However , VRSs are expensive and adding HFB software adds an estimated cost of $ 30,000 to the commercial price . The HFB provided by the Lap Mentor II has not been vali date d by an independent party . We used the Simbionix Lap Mentor II in this study to demonstrate the effect of adding an HFB mechanism in the VRS trainer . MATERIAL S AND METHODS The study was approved by the University of Cincinnati Institutional Review Board . Twenty laparoscopically novice medical students were enrolled . Each student was asked to perform three different tasks on the Lap Mentor II and repeat each one five times . The chosen tasks dem and ed significant amount of traction and counter traction . The first task was to pull leaking tubes enough and clip them . The second task was stretching a jelly plate enough to see its attachments to the floor and cut these attachments . In the third task , the trainee had to separate the gallbladder from its bed on the liver . The students were r and omized into two groups to perform the tasks with and without HFB . We used accuracy , speed , and economy of movement as scales to compare the performance between the two groups . The participants also completed a simple question naire that highlighted age , sex , and experiences in videogame usage . RESULTS The two groups were comparable in age , sex , and videogame playing . No differences in the accuracy , the economy , and the speed of h and movement were noticed . In fact , adding HFB to the Lap Mentor II simulator did not contribute to any improvement in the performance of the trainees . Interestingly , we found that videogame expert players tend to have faster and more economic motion in their dominant h and s. However , the performance accuracy was not significantly affected . CONCLUSION The presence of HFB has less effect than it thought to be on the performance of the novice trainees . This may suggest that better HFB is still needed . However , there may be visual compensation for the lack of haptics . Playing videogames has a positive impact on economy , and the speed of the dominant had motion without affecting its accuracy . Further research is needed to clarify the value of haptics to the expert surgeon and compare it to the new trainees Abstract Background : The fulcrum effect of the body wall on instrument h and ling poses a major obstacle to the mastery of instrument coordination for junior laparoscopic surgeons . This study evaluated three types of laparoscopic simulator training to assess their ability to promote the user 's adaptation to the fulcrum effect . Methods : Thirty-two participants with no previous experience in laparoscopic surgery were r and omly assigned to one of four groups representing different training conditions . One group was assigned to use a virtual reality simulator ( MIST VR ) ; two others were given a laparoscopic Z or U maze-tracking task . The control group received no training . Subjects were asked to perform a 2-min laparoscopic cutting task under normal laparoscopic imaging conditions first before and then after training . Results : In the test trial , subjects who trained on MIST VR made significantly more correct incisions ( p < 0.0001 ) and fewer incorrect incisions ( p < 0.0001 ) . Conclusion : Training on a virtual reality simulator such as MIST VR helps laparoscopic novices adapt to the fulcrum effect faster BACKGROUND Based on prior success of virtual-reality ( VR ) trainers in imparting surgical skills , a r and omized and controlled study was design ed to determine whether VR training improves angled-telescope operative performance . METHODS Third-year medical students received instruction on the use of an angled laparoscope and subsequently underwent performance assessment of angled telescope navigational tasks in an anesthetized porcine model . Subjects were then r and omized to objective -based training with an angled-telescope simulator ( EndoTower ; Verefi Technologies , Elizabethtown , PA ) versus no training , followed by re assessment of performance . RESULTS Initially , there were no significant differences between VR-trained ( n = 9 ) and control ( n = 10 ) groups . After training , object visualization , scope orientation , and horizon error scores were significantly better in VR-trained than control groups ; subject-matched improvement in orientation score was 50.9 % versus 10.8 % ( P < .05 ) . CONCLUSIONS VR training in angled laparoscope use improves operative performance of novices . These data support growing evidence that VR training is highly effective in improving surgical skills outside of the clinical setting Objective To assess the effect of virtual reality training on an actual laparoscopic operation . Design Prospect i ve r and omised controlled and blinded trial . Setting Seven gynaecological departments in the Zeel and region of Denmark . Participants 24 first and second year registrars specialising in gynaecology and obstetrics . Interventions Proficiency based virtual reality simulator training in laparoscopic salpingectomy and st and ard clinical education ( controls ) . Main outcome measure The main outcome measure was technical performance assessed by two independent observers blinded to trainee and training status using a previously vali date d general and task specific rating scale . The secondary outcome measure was operation time in minutes . Results The simulator trained group ( n=11 ) reached a median total score of 33 points ( interquartile range 32 - 36 points ) , equivalent to the experience gained after 20 - 50 laparoscopic procedures , whereas the control group ( n=10 ) reached a median total score of 23 ( 22 - 27 ) points , equivalent to the experience gained from fewer than five procedures ( P<0.001 ) . The median total operation time in the simulator trained group was 12 minutes ( interquartile range 10 - 14 minutes ) and in the control group was 24 ( 20 - 29 ) minutes ( P<0.001 ) . The observers ’ inter-rater agreement was 0.79 . Conclusion Skills in laparoscopic surgery can be increased in a clinical ly relevant manner using proficiency based virtual reality simulator training . The performance level of novices was increased to that of intermediately experienced laparoscopists and operation time was halved . Simulator training should be considered before trainees carry out laparoscopic procedures . Trial registration Clinical Trials.gov NCT00311792 Training on a video trainer or computer-based minimally invasive surgery trainer leads to improved benchtop laparoscopic skill . Recently , improved operative performance from practice on a video trainer was reported . The purpose of this study was three fold : ( a ) to compare psychomotor skill improvement after training on a virtual reality ( VR ) system with that after training on a video-trainer , ( VT ) ( b ) to evaluate whether skills learned on the one training system are transferable to the other , and ( c ) to evaluate whether VR or VT training improves operative performance . For the study , 50 junior surgery residents completed baseline skill testing on both the VR and VT systems . These subjects then were r and omized to either a VR or VT structured training group . After practice , the subjects were tested again on their VR and VT skills . To assess the effect of practice on operative performance , all second-year residents ( n = 19 ) were evaluated on their operative performance during a laparoscopic cholecystectomy before and after skill training . Data are expressed as percentage of improvement in mean score/time . Analysis was performed by Student 's paired t-test . The VR training group showed improvement of 54 % on the VR posttest , as compared with \n Output:\n " }, { "from": "agent", "value": "RESULTS Operation time was reduced by 17 - 50 % by VR training , depending on simulator type and training principles .\nProficiency-based training appeared superior to training based on fixed time or fixed numbers of repetition .\nSimulators offering training for complete operative procedures came out as more efficient than simulators offering only basic skills training .\nSkills in laparoscopic surgery can be increased by proficiency-based procedural VR simulator training .\nThere is substantial evidence ( grade IA - IIB ) to support the use of VR simulators in laparoscopic training" } ]

[ { "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: Two hundred and seventy-four women admitted for delivery of singleton infants were studied for the effects of a preparatory enema on faecal contamination , duration of labour , and the incidence of infection in the newborn . Altogether 149 of the women were given an enema ( controls ) and 125 were not . The two groups showed no significant difference in the degree of faecal contamination during the first and second stages of labour , and the incidences of gross contamination were similar . Contamination after an enema was especially difficult to control , since it was more likely to be fluid . Seven neonates in each group showed evidence of infection , bowel organisms being isolated from four in the no-enema group and two in the control group . Duration s of labour , though not strictly comparable , were similar in the two groups . The findings suggest that when preparing for normal labour the enema should be reserved for women who have not had their bowels open in the past 24 hours and have an obviously loaded rectum on initial pelvic examination The effect of a soap enema on the progress of labour was studied in 160 women admitted for delivery in Esigodini District Hospital . The study was set up as a 1:1 r and omised case control study in 200 women . It was changed to a 1:3 case control study after 82 subjects had been studied , when it became apparent that the midwives were no longer willing to follow the study protocol . Forty women received an enema and 120 did not . Two focus group discussion s were held with 16 women who had an enema . The 12 hospital midwives were asked to give their opinion on enemas . Focus group discussion s were also held with 28 traditional midwives . Dilation of the cervix was 2.19 cm/hour in the non-enema group ( 95pc confidence interval 1.86 - 2.52 ) and 2.00 cm/hour in the enema group ( 95pc confidence interval 1.38 - 2.62 ) . The difference is not significant ( t-test : p-value = 0.58 ) . Pregnant women did not like enemas , midwives preferred not to administer them and were not concerned with contamination during delivery . Traditional midwives do not use enemas in labouring women and consider the possible contamination as normal . It is concluded that there is no benefit from routine enemas in labour Abstract Background Enemas are used during labour in obstetric setting s with the belief that they reduce puerperal and neonatal infections , shorten labour duration , and make delivery cleaner for attending personnel . However , a systematic review of the literature found insufficient evidence to support the use of enemas . The objective of this RCT was to address an identified knowledge gap by determining the effect of routine enemas used during the first stage of labour on puerperal and neonatal infection rates . Methods Design : RCT ( r and omised controlled trial ; r and omized clinical trial ) . Outcomes : Clinical diagnosis of maternal or neonatal infections , labour duration , delivery types , episiotomy rates , and prescription of antibiotics Setting : Tertiary care referral hospital at the Javeriana University ( Bogotá , Colombia ) that attended 3170 births during study period with a caesarean section rate of 26 % . Participants : 443 women admitted for delivery to the obstetrics service ( February 1997 to February 1998 ) and followed for a month after delivery . Inclusion criteria were women with : low risk pregnancy and expected to remain in Bogotá during follow up ; gestational age ≥ 36 weeks ; no pelvic or systemic bacterial infection ; intact membranes ; cervix dilatation ≤7 cm . Intervention : 1 litre saline enema , versus no enema , allocated following a block r and om allocation sequence and using sealed opaque envelopes . Results Allocation provided balanced groups and 86 % of the participants were followed up for one month . The overall infection rate for newborns was 21 % , and 18 % for women . We found no significant differences in puerperal or neonatal infection rates ( Puerperal infection : 41/190 [ 22 % ] with enema v 26/182 [ 14 % ] without enema ; RR 0.66 CI 95 % : 0.43 to 1.03 ; neonatal infection 38/191 [ 20 % ] with enema v 40/179 [ 22 % ] without enema ; RR 1.12 , 95 % CI 95 % 0.76 to 1.66 ) , and median labour time was similar between groups ( 515 min . with enema v 585 min . without enema ; P = 0.24 ) . Enemas did n't significantly change episiorraphy dehiscence rates ( 21/182 [ 12 % ] with enema v 32/190 [ 17 % ] without enema ; P = 0.30 ) . Conclusion This RCT found no evidence to support routine use of enemas during labour . Although these results can not rule out a small clinical effect , it seems unlikely that enemas will improve maternal and neonatal outcomes and provide an overall benefit OBJECTIVE To compare the maternal and neonatal outcomes between enema and no-enema in pregnant women on admission in labor . MATERIAL AND METHOD One thous and and one hundred term pregnant women with labor pain were selected r and omly on admission to be assigned into two groups at Rajavithi Hospital from 1 February 2002 to 15 June 2002 . Five -hundred and thirty-nine cases received enema and five-hundred and sixty one cases received noenema . Seventy three women ( 39 and 34 cases from the enema and no-enema groups , respectively ) were excluded because of cesarean section due to obstetric indications . Five hundred cases received enema and five-hundred and twenty -seven cases received no-enema . All cases were delivered vaginally . RESULTS There was no statistical significant difference between the two groups with regards to maternal age , gestational age , gravidity , parity , mode of delivery , type of episiotomy and degree of perineal tear . Fecal contamination rate during the second stage of labor was significantly higher in the women who received no-enema ( 34.9 % ) in comparision with those receiving enema ( 22.8 % ( p < 0.001 ) . No neonatal infection occurred in both groups . Duration of labor was significantly longer in the women who received no-enema ( 459.8 min ) compared with those who received enema ( 409.4 min ) ( p < 0.001 ) . CONCLUSION No-enema methods on admission in labor had significantly more increase infecal contamination in the second stage of labor and longer duration of labor than the enema method But there was no difference in perineal wound infection and neonatal infection between both groups BACKGROUND Intervention rates in maternity practice s vary considerably across Canadian provinces and territories . The objective of this study was to describe the use of routine interventions and practice s in labor and birth as reported by women in the Maternity Experiences Survey of the Canadian Perinatal Surveillance System . Rates of interventions and practice s are considered in the light of current evidence and both Canadian and international recommendations . METHODS A sample of 8,244 estimated eligible women was identified from a r and omly selected sample of recently born infants drawn from the May 2006 Canadian Census and stratified primarily by province and territory . Birth mothers living with their infants at the time of interview were invited to participate in a computer-assisted telephone interview conducted by Statistics Canada on behalf of the Public Health Agency of Canada . Interviews averaged 45 minutes long and were completed when infants were between 5 and 10 months old ( 9 - 14 mo in the territories ) . Completed responses were obtained from 6,421 women ( 78 % ) . RESULTS Women frequently reported electronic fetal monitoring , a health care practitioner starting or speeding up their labor ( or trying to do so ) , epidural anesthesia , episiotomy , and a supine position for birth . Some women also reported pubic or perineal shaves , enemas , and pushing on the top of their abdomen . CONCLUSIONS Several practice s and interventions were commonly reported in labor and birth in Canada , although evidence and Canadian and international guidelines recommend against their routine use . Practice s not recommended for use at all , such as shaving , were also reported While taking an enema to induce labor is a controversial issue worldwide , in Taiwan it remains a routine procedure in many hospitals in preparation for birth . Episiotomy is also a prevalent procedure performed during the birthing process . Some physicians believe that enemas help reduce the risk of feces contamination of the episiotomy incision and , therefore , are justified as a routine procedure . This study compared the neonatal infection rates , times to appearance of fetal head , times to first post-labor bowel movement , and rates of episiotomy dehiscence of women receiving a pre-labor enema against those who did not . A total of 534 women classified with low-risk pregnancies were recruited from a medical center in central Taiwan and assigned r and omly into one of two groups for a six-month period . The first group ( 264 subjects ) received routine enema procedures prior to delivery in the first 6 months . The second group ( 270 subjects ) did not receive enemas . Study results revealed no significant difference between enema and non-enema groups in terms of infection rates in mothers or infants or in terms of average time to fetal head appearance . While labor duration was the same for the two groups in the first and third stages of labor , the enema group experienced a relatively shorter second stage . No significant difference was observed in times to first post-labor bowel movement or episiotomy dehiscence rates . The results of this study indicate that the administration of enemas as a routine practice prior to labor is not substantiated by medical necessity . However , limitations of the research design suggest that a r and omized clinical trial be adopted in the future to explore further the scientific validity of study results \n Output:\n " }, { "from": "agent", "value": "The evidence provided by the three included RCTs shows that enemas do not have a significant effect on infection rates such as perineal wound infection or other neonatal infections and women 's satisfaction ." } ]

[ { "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 hypotonic ( osmolality 224 mmol/l , sodium 60 mmol/l ) oral rehydration solution ( ORS ) was compared with an isotonic high glucose ORS ( osmolality 304 mmol/l , sodium 60 mmol/l ) in children with acute diarrhoea in a r and omised double blind study . The stool output and hence the mean consumption of ORS for maintenance hydration was less ( p = 0.036 ) in patients receiving hypotonic ( 69 ml/kg ) than isotonic ( 97 ml/kg ) ORS . Hypotonic ORS was more effective in patients with rotavirus positive than with rotavirus negative diarrhoea In a controlled trial in Petrozavodsk , Karelia , the effects of oral rehydration and Lactobacillus strain GG ( LGG ) on recovery from acute diarrhoea ( 27 % rotavirus , 21 % bacterial aetiology ) were studied in 123 children aged between 1 and 36 months of age . On admission to hospital , the patients were first r and omized to receive either isotonic oral rehydration solution ( ORS ) with osmolality 311mosmol/l and sodium 90mmol/l ( WHO‐ORS ) , or a hypotonic ORS with osmolality 224mosmol/l and sodium 60mmol/l ( Light‐ORS ) , and thereafter r and omized to receive either 5 × 109 colony forming units of LGG or a matching placebo . The two ORS performed equally for acute rehydration , and oral rehydration with either ORS was associated with a shorter duration of diarrhoea than intravenous rehydration ( p= 0.036 ) . Patients receiving LGG had a significantly shorter duration of watery diarrhoea [ mean ( SD ) 2.7 ( 2.2 ) days ] than those receiving the placebo [ 3.7 ( 2.8 ) days , p= 0.03 ] . LGG significantly shortened the duration of rotavirus diarrhoea but not diarrhoea with confirmed bacterial aetiology ABSTRACT . Two groups of infants aged 2 to 20 months with moderate to severe dehydration were r and omly assigned to either sucrose high sodium ( 90 mEq/l ) or sucrose low sodium ( 58 mEq/l ) solution in a double blind manner . Rehydration was assessed on clinical grounds and confirmed by serial determination of body weight , hematocrit , total serum protein and blood urea nitrogen . Twenty ( 80 % ) of 25 patients on sucrose high sodium solution and 20 ( 77 % ) of 26 patients on sucrose low sodium solution were successfully hydrated . Only the assigned sucrose‐electrolyte solution was given during the average rehydration period of about 7 hours when the serum electrolytes were remeasured . Three patients on high sodium solution developed mild hypernatremia . Slight hyponatremia was encountered in 2 patients on low sodium solution . Purging rate was significantly higher in patients who failed as compared to those who succeeded . The results of this study suggest that oral sugar electrolyte solution with sodium concentration of 90 mEq/l is safe and effective in the majority of infants with diarrhoeal dehydration of diverse causes . However , intravenous fluids must be available particularly for those with a high purging rate as a significant number of them may fail A r and omized , multicenter clinical trial comparing two oral rehydration solutions ( ORS ) with different sugar content and total osmolality was carried out in France . Solution A had 168 mmol/L of sugar and a total osmolarity of 326 mosm/kg ; solution D had 90 mmol/L of sugar and a total osmolarity of 240 mosm/kg . Weight gain , stool output , and biologic variables were analyzed . This interim analysis included 49 infants ( 27 in group A and 22 in group D ) . Patients in both groups gained weight without any significant difference between the two ORS . Between admission and day 4 , the overall number of stools and the number of liquid stools decreased . Laboratory values were within the normal range on admission and remained unchanged . The weight increase during the first 24 hours and the reduced frequency of stools was similar in both groups Oral rehydration among infants aged 0–3 months has not been adequately investigated . A controlled , r and omized study was thus conducted in 65 young infants hospitalized with acute noncholera dehydrating diarrhea . The study was design ed to compare the efficacy and safety of the st and ard WHO oral glucose-electrolyte solution containing 90 mmol of sodium per liter ( Group A : 22 infants ) with that of an oral glucose-electrolyte solution containing 60 mmol of sodium per liter ( Group B : 22 infants ) and with st and ard intravenous therapy ( Group C : 21 infants ) . Among the 44 infants in Groups A and B , none required intravenous therapy . Dehydration , acidosis , and initial hyponatremia or hypokalemia were corrected with equal efficacy in all the three groups . In the critical first 8 h , the mean sodium absorption was significantly higher ( p < 0.01 ) in Group A. This result ed in hypernatremia ( 50 % ) , periorbital edema ( 50 % ) , mild pedal edema ( 27 % ) , excessive irritability , and convulsions ( 4.5 % ) . The mean serum sodium levels at 8 , 24 , and even 48 h were significantly higher ( p < 0.05 ) than those in Groups B and C. It is concluded that glucose-electrolyte oral solution containing 60 mmol of sodium per liter is as safe and effective as intravenous rehydration for the treatment of noncholera neonatal and early infantile diarrhea , while the st and ard WHO solution carries a significant risk of hypernatremia under similar conditions Although oral glucose-electrolyte solutions containing 90 mmol of sodium per liter have been widely used in the treatment of acute diarrhea among under-nourished children in the developing world , they have rarely been studied in well-nourished children . We therefore conducted a controlled r and omized study among well-nourished children three months to two years who were hospitalized with acute diarrhea ( 52 in the United States , and 94 in Panama ) , to compare the efficacy of this solution with that of one containing 50 mmol of sodium per liter and with st and ard intravenous therapy . Oral rehydration with both solutions according to protocol was successful in 97 of 98 children ( one required unscheduled intravenous therapy ) , and in 87 ( 89 per cent ) no intravenous therapy was required . All of six children admitted with hypernatremia were successfully treated with oral therapy alone . We conclude that glucose-electrolyte oral solutions containing either 50 or 90 mmol of sodium per liter are effective and safe in the treatment of well-nourished children hospitalized with acute diarrhea , and that they may completely replace the intravenous fluids in the majority of such children The paper describes the first controlled trial of an oral glucose electrolyte solution design ed on the basis of the optimum pathophysiological needs for rehydration in infantile diarrahoea . The solution , having a sodium concentration of 50 mmol/l , was tried in a group of 20 infants with moderate to severe dehydration due to acute diarrhoea and was compared with a matched group of 19 infants predominantly under 2 years of age taking a ' st and ard ' oral solution with a sodium concentration of 90 mmol/l . They could be hydrated as well with a low sodium oral solution alone as with the st and ard solution . Intravenous fluid was not required in either group . The group treated with the high soldium ' st and ard ' solution appeared to develop hypernatraemia and /or periorbital oedema more frequently than the other group . Also , the low sodium solution eliminated the need for additional free water orally Two hypotonic oral rehydration solutions with osmolarities of 224 mosmol/l ( Na+ 60 mmol/l , glucose 84 mmol/l ) and 204 mosmol/l ( Na+ 60 mmol/l , glucose 64 mmol/l ) , respectively , and oral treatment withLactobacillus GG were evaluated in a double blind trial in children aged 6–36 months hospitalised for acute diarrhoea . Early administration ofLactobacillus GG at the start of oral rehydration result ed in the shortest duration of diarrhoea , best weight gain , and fastest correction of acidosis . A reduced osmolarity oral rehydration solution ( 224 mosmol/l ) combined with early administration of Lactobacillus GG is an effective treatment for acute diarrhoea in young children ; further reduction of osmolarity may not be beneficial Previously we reported that st and ard oral rehydration salts ( ORS ) solution is not as effective as a reduced-osmolarity glucose-based ORS for the treatment of children with acute noncholera diarrhoea : with st and ard ORS the diarrhoea lasts longer , stool output is greater , serum sodium is higher , and there is more need for supplemental intravenous infusion . We studied a reduced-osmolarity maltodextrin (MD)-based ORS to determine whether it had similar benefits , and also the effect of sugar malabsorption on the efficacy of st and ard and MD-based ORS . A total of 90 boys aged 3 - 24 months with acute noncholera diarrhoea and moderate dehydration were r and omly assigned to either st and ard ORS ( glucose 20 g/l , osmolarity 311 mmol/l ) or MD-ORS ( MD 50 g/l , osmolarity 227 mmol/l ) . There were no differences in treatment results . Some 46 % of subjects had a high total stool output ( > 300 g/kg ) , which was unrelated to the type of ORS given . High stool output was significantly associated with a longer duration of diarrhoea ( 33 vs. 15 hours ; P < 0.001 ) , a persistently elevated serum sodium ( 149 vs. 144 mmol/l at 24 h ; P < 0.02 ) , the need for intravenous infusion ( 11/41 vs. 0/48 ; P < 0.002 ) , and an increase in faecal reducing substances ( 10.8 vs. 3.4 g/l at 24 h ; P < 0.001 ) . We conclude that some children given st and ard ORS develop osmotic diarrhoea owing to the combined effect of transient sugar malabsorption and slight hypertonicity of the ORS . Earlier studies show that this adverse outcome can largely be avoided when extra water is given in reduced-osmolarity glucose-based ORS . Reduced osmolarity has no benefit , however , when glucose is replaced by maltodextrin , probably because the sugars released by hydrolysis of MD , when malabsorbed , raise the intraluminal osmolarity to equal or exceed that of st and ard ORS . Thus , reduced-osmolarity glucose-based ORS is superior to both st and ard ORS and reduced-osmolarity solutions based on maltodextrin and probably other complex carbohydrates . Studies are in progress to define the optimal formulation of reduced-osmolarity glucose-based ORS Male children ( N = 101 ) 6–35 months of age presenting with acute watery diarrhea for 48 h at home before hospitalization were admitted into a r and omized , double-blind clinical trial . Fifty-one children were treated with st and ard oral rehydration solution ( ORS ) ( World Health Organization [ WHO ] formulation containing citrate ) and 50 were treated with an improved ORS formulation ( containing , in addition to the st and ard formula , 20 g maltodextrin instead of glucose , and 4 g glycine and 4 g glycyl-glycine ) . None were given antibiotics . No i.v . infusions were given . Rotavirus was detected by enzyme-linked immunosorbent assay in stools of 43 children . Clinical characteristics of children in the two treatment groups were comparable . Improved ORS did not produce significant reduction in the volume of diarrhea stools . Children given improved ORS had greater weight gain than that observed in children treated with st and ard ORS , but the differences were not statistically significant except at the end of the first 24 h. Among children with rotavirus diarrhea , no significant differences were observed between the 23 children who received improved ORS and the 20 who received st and ard ORS Summary The clinical efficacy of a diluted oral rehydration salts ( ORS ) solution was compared in a pilot study with that of intravenous ( i.v . ) therapy and of st and ard World Health Organization (WHO)/United Nations Childrens Fund ( UNICEF ) ORS solution in children with acute diarrhea . Sixty-one boys aged 3 to 24 months , admitted to hospital with acute diarrhea and signs of dehydration , were r and omly assigned to groups receiving st and ard ORS solution , diluted ORS solution , or i.v . therapy . In children treated with st and ard ORS solution and small amounts of plain water , the total fluid \n Output:\n " }, { "from": "agent", "value": "REVIEW ER 'S CONCLUSIONS In children admitted to hospital with diarrhoea , reduced osmolarity ORS when compared to WHO st and ard ORS is associated with fewer unscheduled intravenous fluid infusions , lower stool volume post r and omization , and less vomiting .\nNo additional risk of developing hyponatraemia when compared with WHO st and ard ORS was detected" } ]

[ { "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 paced auditory serial addition test ( PASAT ) , a subtest of the multiple sclerosis functional composite score ( MSFC ) , is increasingly used in the evaluation of cognitive function in multiple sclerosis ( MS ) . While patient acceptance for the PASAT is low , its visual version , the paced visual serial addition test ( PVSAT ) , is perceived to be better tolerated . The aim of this study was to investigate the interchangeability of PVSAT and PASAT in the evaluation of cognitive function in MS . Twenty-one normal controls and 50 patients with clinical ly definite MS were tested with PASAT and PVSAT . Both for PASAT and PVSAT , 3 and 2-second versions of two parallel test forms were used . In the PVSAT , the PASAT stimuli were shown on a computer screen . Patients were also tested with the other two MSFC subtests , i.e. the nine-hole pegboard test and timed 25-foot walk test , to calculate MSFC scores . PASAT-3 correlated highly with both PVSAT-3 and PVSAT-2 . MSFC-v scores calculated with PVSAT-2 and PVSAT-3 values correlated highly with MSFC scores calculated with PASAT-3 results . The results suggest that the PVSAT can be used as an alternative for the PASAT in the MSFC RATIONALE Multiple sclerosis ( MS ) patients exhibit cognitive deficits that negatively impact quality of life . The Relative Consequence Model suggests that problems with information processing speed ( IPS ) may be the basis for many of these cognitive difficulties . OBJECTIVE To investigate , with functional magnetic resonance imaging ( fMRI ) , if an IPS task ( the Computerized Test of Information Processing ( CTIP ) ) would reveal neurophysiological differences between MS patients and matched controls . METHODS Performance and neural activation were investigated in twelve cognitively impaired MS patients and 12 matched controls as each performed the CTIP . The CTIP measures reaction time ( RT ) and errors on three tasks ( simple RT , choice RT and semantic search RT ) with increasing cognitive dem and s. RESULTS Participants demonstrated increased RT with increased task complexity . Patients showed longer RTs for the choice RT condition than controls but the pattern of performance across tasks did not vary between groups . Errors were not significantly different between groups . Imaging results for both the choice and the semantic search conditions revealed significant differences between groups involving a compensatory increase in activation in MS participants compared to controls in prefrontal cortex and right temporal gyri . However , there were also areas of decreased activity in MS participants when compared with controls in left temporal gyri . CONCLUSIONS Significantly different neural activation patterns between MS patients and controls were associated with IPS , as measured by the CTIP This study examined whether verbal and visual memory impairments in multiple sclerosis ( MS ) are attributable to deficits in acquisition , storage , or retrieval . Volunteers with MS ( n = 40 ) and healthy controls ( n = 20 ) rehearsed a word list and a checkerboard pattern using a selective reminding procedure until two consecutive error-free trials were attained . Recall and recognition were assessed after 30 min and 90 min ( and 1 week for verbal material ) delays . The MS group required significantly more trials to attain criterion on both learning tests . Once equated for acquisition , both groups performed similarly on verbal recall and recognition . However the MS group performed significantly worse on measures of visual recall and recognition . The results suggest that the verbal memory impairment in MS is due to deficient acquisition , while the visual memory impairment in MS is attributable to deficits in acquisition and storage Cognitive impairment is amongst the main symptoms affecting multiple sclerosis ( MS ) and should be comprehensively and accurately assessed . To study the added value of a computerized neuropsychological battery enabling the measurement of response times in the cognitive domains , 58 r and omly selected MS patients and 71 age- , gender- and education-matched healthy subjects were evaluated . Construct and discriminant validity were assessed for the st and ard Neuropsychological Screening Battery for Multiple Sclerosis ( NSBMS ) and the Mindstreams Computerized Cognitive Battery ( MCCB ) . The MCCB demonstrated good construct validity in comparison with the NSBMS in memory ( P < 0.001 ) , executive function ( P < 0.001 ) , attention ( P < 0.05 ) and information processing ( P < 0.05 ) domains . In addition , it showed high discriminant validity most prominently for executive function , attention and motor skills ( P < 0.001 ) . Response times measured by the computerized battery were longer in all cognitive domains and varied with cognitive load , demonstrating that response time deficits in MS are associated with particular task dem and s. We conclude that in MS prolonged response times on a range of cognitive tasks signify abnormal conduction within demyelinative tracts The initial step in the development of a new computer-based neuropsychological testing system is described . A new hardware-software system and a screening battery consisting of an orientation task and five cognitive tests has been implemented . This novel screening battery is design ed for use in identifying individuals among exposed groups who may require more extensive follow-up neuropsychological evaluation . Sophisticated , but currently available , and relatively inexpensive hardware and software technology are employed , introducing an improvement over existing computer-based batteries . Use of a digitized speech production device for producing instructions facilitates testing of illiterate subjects , use of auditory stimulus material s , and relatively easy translation of the testing instructions to other language s. Use of a pen-based notebook computer enables responding by the subject in a manner that is both natural and analogous to that used in existing paper- and -pencil testing instruments . Five neuropsychological tests were developed to cover a range of cognitive domains : 1 ) verbal list learning and recognition memory , 2 ) visual memory span , 3 ) conceptual and motor tracking , 4 ) psychomotor speed and accuracy , and 5 ) delayed verbal recognition . The screening instrument has been pilot-tested for feasibility of use among out patients at an occupational medicine clinic and among community-dwelling older adults . This instrument is intended to provide a st and ardized efficient , cost-effective method for widespread use in occupational medicine and public health to detect and track sub clinical neurotoxic effects and to prevent additional harmful exposure . Additional aspects of development of the computer-based testing system are discussed OBJECTIVE To examine the use of an innovative approach for assessing everyday life activities of people with multiple sclerosis ( MS ) : Actual Reality . Actual Reality is a performance-based assessment approach that involves the use of the internet to perform real , everyday life activities . DESIGN A between-subjects design . SETTING Outpatient rehabilitation institute . PARTICIPANTS Persons ( n=21 ) with clinical ly definite MS and healthy controls ( HCs ) ( n=18 ) without any reported neurologic disabilities participated in this study . Participants were between the ages of 21 to 60 years , and the sample consisted of volunteer sample . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Participants were asked to access the internet to purchase airline tickets for a round trip flight and were administered the Minimal Assessment of Cognitive Functioning in Multiple Sclerosis . Participants also completed question naires to assess quality of life ( Functional Assessment of Multiple Sclerosis ) , functional status ( Functional Behavior Profile ) , and prior Internet experience . RESULTS The MS group displayed significantly more difficulties than the HC group in accurately and independently completing the Actual Reality task primarily because of cognitive impairment . Self-report of quality of life and functional status were not correlated with Actual Reality performance in the group of people with MS . However , the self-report measures were significantly associated with affective symptomatology . CONCLUSIONS These results provide initial evidence supporting the use of the Actual Reality approach in assessing persons with MS performing everyday life activities . Actual Reality is a significant step forward in increasing the sensitivity , accessibility , and relevancy of functional assessment s in people with cognitive and physical disabilities \n Output:\n " }, { "from": "agent", "value": "Conclusion : We identified several CNADs that are valid to screen for MS-related cognitive impairment , or to supplement full , conventional neuropsychological assessment ." } ]

[ { "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 In the Sahel and sub-Sahelian regions of Africa , malaria transmission is highly seasonal . During a short period of high malaria transmission , mortality and morbidity are high in children under age 5 years . We assessed the efficacy of seasonal intermittent preventive treatment-a full dose of antimalarial treatment given at defined times without previous testing for malaria infection . METHODS We did a r and omised , placebo-controlled , double-blind trial of the effect of intermittent preventive treatment on morbidity from malaria in three health-care centres in Niakhar , a rural area of Senegal . 1136 children aged 2 - 59 months received either one dose of artesunate plus one dose of sulfadoxine-pyrimethamine or two placebos on three occasions during the malaria transmission season . The primary outcome was a first or single episode of clinical malaria detected through active or passive case detection . Primary analysis was by intention-to-treat . This study is registered with , number NCT00132561 . FINDINGS During 13 weeks of follow-up , the intervention led to an 86 % ( 95 % CI 80 - 90 ) reduction in the occurrence of clinical episodes of malaria . With passive case detection , protective efficacy against malaria was 86 % ( 77 - 92 ) , and when detected actively was 86 % ( 78 - 91 ) . The incidence of malaria in children on active drugs was 308 episodes per 1000 person-years at risk , whereas in those on placebo it was 2250 episodes per 1000 person-years at risk . 13 children were not included in the intention-to-treat analysis , which was restricted to children who received a first dose of antimalarial or placebo . There was an increase in vomiting in children who received the active drugs , but generally the intervention was well tolerated . INTERPRETATION Intermittent preventive treatment could be highly effective for prevention of malaria in children under 5 years of age living in areas of seasonal malaria infection In a controlled trial of weekly malaria chemoprophylaxis with chloroquine and pyrimethamine there were no significant differences in type and frequency of severe morbidity during chemoprophylaxis . Administration of chemoprophylaxis during the current and immediately preceding month was associated with significantly fewer episodes of severe morbidity in the chloroquine and pyrimethamine groups when each was compared with the control multivite group . After chemoprophylaxis had been stopped , significantly more episodes of severe morbidity occurred in the chloroquine group than the control group , but a similar trend in the pyrimethamine group was not statistically significant . In the control group most of the episodes of severe morbidity , including those episodes which were associated with heavy parasitaemia , occurred below the age of 4 years . In contrast , the children who received chemoprophylaxis continued to experience such illness at older ages . The difference between the chloroquine group and the control group in respect of age at time of severe morbidity was statistically significant A trial of suppression of malaria by administration of combined sulphadoxine-pyrimethamine tablets every 28 days was undertaken in West Malaysia during 1972 . One thous and subjects were followed over a 10-month period , including control groups on placebo and on weekly chloroquine . Subjects were examined monthly for parasitaemia , drug reactions , leucopenia , teratogenicity and haemolysis among the subjects deficient in glucose-6-phosphate dehydrogenase . Rates of new infections in the placebo group were 8.0 % with Plasmodium falciparum and 6.2 % with P. vivax ; in the group receiving weekly chloroquine , 5.1 % P. falciparum and 0.3 % P. vivax ; and in the group receiving monthly sulphadoxine-pyrimethamine , 0.3 % P. Falciparum and 1.0 % P. vivax . The effective rate of cure of new infections with P. falciparum by a single suppressive dose of combined sulphadoxine-pyrimethamine given the following month was 88.7 % . No serious side effects were observed After treatment with chloroquine and pyrimethamine/sulfadoxine , 118 school children aged 6 to 10 years living near the Kenyan coast were enrolled in a malaria chemoprophylaxis study and followed up for 20 weeks . Children were r and omly assigned to receive either chlorproguanil 20 mg weekly ( n = 78 ) or placebo ( n = 37 ) . The attack rate of Plasmodium falciparum infection was 42 % in chlorproguanil recipients ( 39.8 episodes per 1000 person-weeks of prophylaxis ) and 73 % in placebo recipients ( 69.2 episodes per 1000 person-weeks , p less than 0.02 ) . Sensitivity tests on 36 isolates successfully cultured in vitro showed that all 21 isolates from chloroproguanil recipients were resistant to dihydrofolate-reductase inhibitors , whereas only 3 of 15 isolates from the placebo group were resistant ( p less than 10(-6 ) ) . Chlorproguanil in a weekly adult dose of 40 mg does not provide adequate prophylaxis against P falciparum in Kenya , probably because drug levels between doses fall below those required to suppress parasites resistant to dihydrofolate-reductase inhibitors A double-blind , community-r and omized , placebo-controlled trial was conducted in a rural area of The Gambia between June and December 1999 to test whether a reduction in the infectious reservoir can reduce malaria transmission . Overall 14,017 ( 85 % ) individuals living in the study area were treated with either placebo or sulfadoxine-pyrimethamine ( SP ) combined with a single dose of artesunate ( AS ) . Following the mass drug administration ( MDA ) 1375 children aged 6 months to 10 years were kept under surveillance for clinical malaria in 18 villages throughout the 1999 malaria transmission season . During a 20-week surveillance period 637 episodes of malaria were detected . The mean incidence rate was 2.5/100 child-weeks in the placebo villages , and 2.3/100 child-weeks in villages that received SP + AS . The mean rate ratio , adjusted for individual and village-level covariates , was 0.91 ( 95 % CI 0.68 - 1.22 , P = 0.49 ) . During the first 2 months of surveillance , the malaria incidence was lower in treated villages . After 2 months the incidence was slightly higher in the MDA group but this was not statistically significant . Overall , no benefit of the MDA could be detected . The reason for the absence of an impact on malaria transmission is probably the very high basic reproductive number of malaria , and the persistence of mature gametocytes , which are not affected by AS treatment This study was aim ed at delineating characteristics of naturally acquired immunity against the merozoite surface antigen-1 ( MSP-1 ) of Plasmodium falciparum , a c and i date malaria vaccine antigen . A case/control study was performed on 75 case/control pairs of infants with febrile illness at the time of the first detected infection indicating a clinical case . The presence and level of antibodies at one month prior to the first infection and at the time of the first infection in the afebrile group was significantly higher than in the febrile group . Decreased parasite density and decreased infection-related loss of hemoglobin was seen in infants with anti-MSP-1(19kD ) IgG antibodies . In addition , mothers who were positive for the presence of these antibodies conferred protection against placental infection and infection in their infants . In this study , development of anti-MSP-1(19kD ) antibody responses in 24 infants were studied longitudinally using monthly serum sample s collected from birth until approximately one year of age . In addition , umbilical cord blood sera and respective mothers ' sera were analyzed . Longitudinal studies of antibody responses revealed several short-lived IgG and IgM peaks throughout an infant 's first year that correlated with detection of parasitemia . The protection against parasitemia and febrile illness was observed in infants when anti-MSP-1(19kD ) antibodies were present ; when infants were negative for IgG , they had a 10-times greater risk of becoming parasitemic . These data from a longitudinal and prospect i ve study of malaria suggest a protective role for anti-MSP-1(19kD ) antibodies in infants and pregnant women Stopping antimalarial chemoprophylaxis can be followed by increased risk of malaria , suggesting that it interferes with the development of antimalarial immunity . We report analysis of extended follow-up until age 2 years of a r and omised , placebo-controlled double-blind trial of intermittent preventive antimalarial treatment in infants . The rate of clinical malaria ( events per person-year at risk , starting 1 month after final dose of intermittent treatment ) was 0.28 in the sulfadoxine-pyrimethamine group and 0.43 in the placebo group ( protective effect 36 % , 95 % CI 11 - 53 ) . Intermittent treatment produced a sustained reduction in the risk of clinical malaria extending well beyond the duration of the pharmacological effects of the drugs , excluding a so-called rebound effect and suggesting that such treatment could facilitate development of immunity against Plasmodium falciparum BACKGROUND Intermittent preventive antimalarial treatment in infants ( IPTi ) with sulfadoxine-pyrimethamine reduces falciparum malaria and anemia but has not been evaluated in areas with intense perennial malaria transmission . It is unknown whether an additional treatment in the second year of life prolongs protection . METHODS A r and omized , double-blinded , placebo-controlled trial with administration of sulfadoxine-pyrimethamine therapy at 3 , 9 , and 15 months of age was conducted with 1070 children in an area in Ghana where malaria is holoendemic . Participants were monitored for 21 months after recruitment through active follow-up visits and passive case detection . The primary end point was malaria incidence , and additional outcome measures were anemia , outpatient visits , hospital admissions , and mortality . Stratified analyses for 6-month periods after each treatment were performed . RESULTS Protective efficacy against malaria episodes was 20 % ( 95 % confidence interval [ CI ] , 11%-29 % ) . The frequency of malaria episodes was reduced after the first 2 sulfadoxine-pyrimethamine applications ( protective efficacy , 23 % [ 95 % CI , 6%-36 % ] after the first dose and 17 % [ 95 % CI , 1%-30 % ] after the second dose ) . After the third treatment at month 15 , however , no protection was achieved . Protection against the first or single anemia episode was only significant after the first IPTi dose ( protective efficacy , 30 % ; 95 % CI , 5%-49 % ) . The number of anemia episodes increased after the last IPTi dose ( protective efficacy , -24 % ; 95 % CI , -50 % to -2 % ) . CONCLUSION In an area of intense perennial malaria transmission , sulfadoxine-pyrimethamine-based IPTi conferred considerably lower protection than reported in areas where the disease is moderately or seasonally endemic . Protective efficacy is age-dependent , and extension of IPTi into the second year of life does not provide any benefit In a r and omized controlled study of malaria prophylaxis , dapsone-pyrimethamine at a weekly dosage of dapsone 50 - 100 mg with pyrimethamine 6.25 - 12.5 mg or placebo was administered to 166 school children for 17 weeks . Fortnightly parasitological controls revealed 28 infections in the placebo group and none in the dapsone-pyrimethamine group . It is concluded that weekly dapsone-pyrimethamine is effective for the prophylaxis of falciparum malaria in Mozambique BACKGROUND Clinical malaria and severe anaemia are major causes of paediatric hospital admission and death in many malaria-endemic setting s. In the absence of an effective and affordable vaccine , control programmes continue to rely on case management while attempting the large-scale deployment of insecticide-treated nets . We did a r and omised , placebo-controlled trial to assess the efficacy and safety of intermittent sulphadoxine-pyrimethamine treatment on the rate of malaria and severe anaemia in infants in a rural area of Tanzania . METHODS We r and omly assigned 701 children living in Ifakara , southern Tanzania , sulphadoxine-pyrimethamine or placebo at 2 , 3 , and 9 months of age . All children received iron supplementation between 2 and 6 months of age . The intervention was given alongside routine vaccinations delivered through WHO 's Exp and ed Program on Immunisation ( EPI ) . The primary outcome measures were first or only episode of clinical malaria , and severe anaemia in the period from recruitment to 1 year of age . Morbidity monitoring through a hospital-based passive case-detection system was complemented by cross-sectional surveys at 12 and 18 months of age . Results were expressed in terms of protective efficacy ( 100 [ 1-hazard ratio]% ) and analysis was by intention to treat . FINDINGS 40 children dropped out ( 16 died , \n Output:\n " }, { "from": "agent", "value": "Prophylaxis and intermittent treatment with antimalarial drugs reduce clinical malaria and severe anaemia in preschool children" } ]

[ { "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 study estimates the relative importance of specific types of traumas experienced in the community in terms of their prevalence and risk of leading to posttraumatic stress disorder ( PTSD ) . METHODS A representative sample of 2181 persons in the Detroit area aged 18 to 45 years were interviewed by telephone to assess the lifetime history of traumatic events and PTSD , according to DSM-IV . Posttraumatic stress disorder was assessed with respect to a r and omly selected trauma from the list of traumas reported by each respondent , using a modified version of the Diagnostic Interview Schedule , Version IV , and the World Health Organization Composite International Diagnostic Interview . RESULTS The conditional risk of PTSD following exposure to trauma was 9.2 % . The highest risk of PTSD was associated with assaultive violence ( 20.9 % ) . The trauma most often reported as the precipitating event among persons with PTSD ( 31 % of all PTSD cases ) was sudden unexpected death of a loved one , an event experienced by 60 % of the sample , and with a moderate risk of PTSD ( 14.3 % ) . Women were at higher risk of PTSD than men , controlling for type of trauma . CONCLUSIONS The risk of PTSD associated with a representative sample of traumas is less than previously estimated . Previous studies have overestimated the conditional risk of PTSD by focusing on the worst events the respondents had ever experienced . Although recent research has focused on combat , rape , and other assaultive violence as causes of PTSD , sudden unexpected death of a loved one is a far more important cause of PTSD in the community , accounting for nearly one third of PTSD cases An altered function of the hypothalamic-pituitary-adrenal axis is assumed to be characteristic for Posttraumatic Stress Disorder ( PTSD ) , although there is inconsistent empirical evidence . Only few studies examined the awakening cortisol response and a daytime profile in PTSD . Salivary cortisol levels were measured at seven intervals from awakening until 8 PM in trauma-exposed subjects with ( N=29 ) and without PTSD ( N=19 ) and in 15 non-exposed controls . While the three groups did not differ with respect to their first cortisol level immediately after awakening , the expected cortisol increase to awakening 15 - 60 min later was significantly lower in PTSD patients compared to non-PTSD subjects and healthy controls . This effect remained stable when trauma-exposed subjects with comorbid major depression were excluded from the analysis . A significant negative correlation between the overall cortisol secretion ( AUC(G ) ) and overall PTSD symptomatology and hyper-arousal symptoms was found . The findings are discussed in light of the hypothesis of a counterregulation of hyper-arousal symptoms and chronic stress in PTSD BACKGROUND Exposure to intense physical and psychological stress during septic shock can result in posttraumatic stress disorder in survivors . Patients with chronic posttraumatic stress disorder often show sustained reductions in serum cortisol concentration . This investigation examines whether increasing serum cortisol levels with hydrocortisone treatment during septic shock reduces the incidence of posttraumatic stress disorder in survivors . METHODS Patients ( n = 20 ) were recruited from a prospect i ve , r and omized double-blind study on the hemodynamic effects of hydrocortisone during septic shock . Eleven patients had received placebo and nine stress doses of hydrocortisone . Posttraumatic stress disorder was diagnosed 31 months ( median ) after intensive care unit discharge using SCID-IV ( DSM-IV- criteria ) . Furthermore , the number of categories of traumatic memory from ICU treatment was determined in both groups at that time . RESULTS Only one of nine patients from the hydrocortisone group developed posttraumatic stress disorder , compared with seven of 11 patients in the placebo group ( p = .02 ) . There was no significant difference with regard to the number of categories of traumatic memory between the hydrocortisone and placebo groups . CONCLUSIONS The administration of hydrocortisone during septic shock in a dosage similar to the endogenous maximal production rate was associated with a lower incidence of posttraumatic stress disorder in long-term survivors , which seems to be independent of the number of categories of traumatic memory BACKGROUND We examine whether traumatic events increase the risk for major depression independent of their effects on posttraumatic stress disorder ( PTSD ) . METHODS Data come from the Epidemiologic Study of Young Adults in southeast Michigan ( N = 1007 ) . Retrospective and prospect i ve data were used to estimate the risk of major depression in persons with PTSD and persons exposed to trauma with no PTSD , compared with persons who did not experience a trauma . National Comorbidity Survey data were used to evaluate the influence of trauma type . RESULTS In the retrospective lifetime data , hazard ratios were , for first-onset major depression in exposed persons with PTSD , 2.8 and , in exposed persons with no PTSD , 1.3 ( not significant ) , as compared with persons who were not exposed . Corresponding estimates from the prospect i ve data were 11.7 and 1.4 ( not significant ) . The difference in the risk for depression associated with PTSD versus exposure without PTSD is unlikely to be due to differences in trauma type . CONCLUSIONS The findings of a markedly increased risk for major depression in persons with PTSD , but not in exposed persons without PTSD , do not support the hypothesis that PTSD and major depression in trauma victims are influenced by separate vulnerabilities BACKGROUND While enhanced cortisol suppression in response to dexamethasone is one of the most consistent biological findings in posttraumatic stress disorder ( PTSD ) , the relative contribution of trauma exposure to this finding remains unclear . METHODS Assessment of diurnal salivary cortisol levels and 1600 h salivary cortisol before and after oral administration of 0.5 mg dexamethasone in veterans with PTSD , veterans without PTSD ( trauma controls ) and healthy controls . Assessment of 1600 h plasma cortisol , ACTH and corticotrophin binding globulin ( CBG ) in response to dexamethasone in PTSD patients and trauma controls . RESULTS Both PTSD patients and trauma controls demonstrated significantly more salivary cortisol suppression compared to healthy controls . Salivary cortisol , plasma cortisol and ACTH suppression as well as CBG levels did not differ between PTSD patients and trauma controls . PTSD patients showed a reduced awakening cortisol response ( ACR ) compared to healthy controls that correlated significantly with PTSD symptoms . No significant differences were observed in ACR between PTSD patients and trauma controls . CONCLUSIONS These data suggest that enhanced cortisol suppression to dexamethasone is related to trauma exposure and not specifically to PTSD . The correlation between the ACR and PTSD severity suggests that a flattened ACR may be a result of clinical symptoms OBJECTIVE The purpose of this study was to prospect ively evaluate the onset , overlap , and course of posttraumatic stress disorder ( PTSD ) and major depression following traumatic events . METHOD The occurrence of PTSD and major depression and the intensity of related symptoms were assessed in 211 trauma survivors recruited from a general hospital 's emergency room . Psychometrics and structured clinical interview ( the Structured Clinical Interview for DSM-III-R and the Clinician-Administered PTSD Scale ) were administered 1 week , 1 month , and 4 months after the traumatic event . Heart rate was assessed upon arrival at the emergency room for subjects with physical injury . Twenty-three subjects with PTSD and 35 matched comparison subjects were followed for 1 year . RESULTS Major depression and PTSD occurred early on after trauma ; patients with these diagnoses had similar recovery rates : 63 survivors ( 29.9 % ) met criteria for PTSD at 1 month , and 37 ( 17.5 % ) had PTSD at 4 months . Forty subjects ( 19.0 % ) met criteria for major depression at 1 month , and 30 ( 14.2 % ) had major depression at 4 months . Comorbid depression occurred in 44.5 % of PTSD patients at 1 month and in 43.2 % at 4 months . Comorbidity was associated with greater symptom severity and lower levels of functioning . Survivors with PTSD had higher heart rate levels at the emergency room and reported more intrusive symptoms , exaggerated startle , and peritraumatic dissociation than those with major depression . Prior depression was associated with a higher prevalence of major depression and with more reported symptoms . CONCLUSIONS Major depression and PTSD are independent sequelae of traumatic events , have similar prognoses , and interact to increase distress and dysfunction . Both should be targeted by early treatment interventions and by neurobiological research BACKGROUND The hypothalamic-pituitary-adrenal axis and the catecholaminergic system are involved in the pathophysiology of post-traumatic stress disorder ( PTSD ) . This was a prospect i ve and longitudinal study of neuroendocrine physiology in children with PTSD following a motor vehicle accident ( MVA ) . METHODS Sixty children aged 7 - 18 were studied immediately after an MVA and 1 and 6 months later . Fasting morning plasma catecholamine and serum cortisol concentrations were measured . Salivary cortisol concentrations were measured serially five times daily to examine circadian variation in all three assessment s. Values were compared between those who did ( PTSD ) or did not develop PTSD ( non-PTSD ) after the trauma and a control group at months 1 and 6 . RESULTS Twenty-three of the children had PTSD at the 1-month and 9 children at the 6-month evaluations . 1 ) Plasma noradrenaline concentrations were higher in the PTSD group than in the other two groups at both months 1 and 6 ( p = .001 and p = .001 , respectively ) . Additionally , the PTSD patients presented with significantly higher salivary cortisol concentrations at 18.00 ( p = .03 ) and 21.00 ( p = .04 ) at month 1.2 ) Eight children suffering from PTSD at both months 1 and 6 had significantly elevated plasma noradrenaline concentrations at month 6 compared with those at month 1 and at baseline and to the other two groups ( within subjects : p < .001 ; between subjects : p = .005 ) . The initially elevated evening salivary cortisol concentrations in this group normalized at month 6 . CONCLUSIONS This progressive divergence of noradrenaline and cortisol concentrations over time might underlie the natural history and pathophysiology of PTSD BACKGROUND This study was design ed to examine the relationship between urinary hormone levels collected upon admission to the trauma unit following a motor vehicle accident and posttraumatic stress disorder symptomatology 1 month later . METHODS Fifteen-hour urine sample s were collected from 63 male and 36 female motor vehicle accident victims and were used to assess levels of catecholamines and cortisol reflecting peritraumatic and acute-phase posttraumatic levels . Presence of posttraumatic stress disorder symptomatology was assessed 1 month after the accident . RESULTS Motor vehicle accident victims subsequently diagnosed with acute posttraumatic stress disorder excreted significantly lower levels of cortisol in 15-hour urines collected upon admission to the hospital . In addition , urinary levels of cortisol predicted a significant percentage of the variance in intrusive and avoidant thoughts 1 month after the accident . CONCLUSIONS The results of our study suggest that initial cortisol levels in the immediate aftermath of a traumatic event contribute , in part , to subsequent symptoms of posttraumatic stress disorder BACKGROUND Because alterations in cortisol negative feedback inhibition associated with aging are generally opposite of those observed in posttraumatic stress disorder ( PTSD ) , we examined the cortisol and glucocorticoid receptor ( GR ) response to dexamethasone ( DEX ) in older trauma survivors . METHODS Twenty-three Holocaust survivors ( 9 men , 14 women ) , 27 combat veterans ( all male ) , and 10 comparison subjects ( 7 men , 3 women ) provided sample s for plasma or salivary cortisol and glucocorticoid receptor determination in mononuclear leukocytes at 8:00 AM on the day of , and following , 0.5 mg of DEX at 11:00 PM . RESULTS Greater percent suppression of cortisol and lymphocyte GR was observed in older trauma survivors with PTSD compared to survivors without PTSD and comparison subjects . There was a significant main effect of depression in the direction of reduced suppression following DEX , consistent with the effects of DEX in major depressive disorder patients . Responses to DEX were uncorrelated with PTSD symptom severity , but cortisol suppression was associated with years elapsed since the most recent , but not focal , traumatic event . CONCLUSIONS The response to DEX is generally similar in older and younger trauma survivors , but the findings suggest that age , symptom severity , and lifetime trauma exposure characteristics may influence this response OBJECTIVE To evaluate cortisol suppression following 0.5 mg of dexamethasone ( DEX ) in trauma survivors ( N=52 ) with posttraumatic stress disorder ( PTSD ) , major depressive disorder ( MDD ) , both , or neither disorder , and in subjects never exposed to trauma ( N=10 ) , in order to examine interactions between diagnosis and trauma history on cortisol negative feedback inhibition \n Output:\n " }, { "from": "agent", "value": "These findings suggest that enhanced HPA feedback function may be a marker of trauma-exposure rather than a specific mechanism of vulnerability for PTSD , whereas lower daily cortisol output may be associated with PTSD in particular" } ]

[ { "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: Epidemiologic data and animal experiments suggest that dietary fat may influence risk of breast cancer . To determine whether intervention with a low-fat , high-carbohydrate diet would reduce breast cancer incidence in women at increased risk of the disease , we carried out a r and omized controlled trial in Canada . We recruited 4,690 women with extensive mammographic density and r and omized them to an intervention group or a comparison group . The intervention group received intensive dietary counseling to reduce fat intake to a target of 15 % of calories and increase carbohydrate to 65 % of calories . Dietary intakes were assessed throughout using food records . Subjects were followed for at least 7 years and for an average of 10 years . The main outcome was invasive breast cancer . Percentage of calories from fat in the intervention group decreased from 30 % at baseline to 20 % after r and omization and remained 9 % to 10 % lower than the comparison group throughout . There were 118 invasive breast cancers in the intervention group and 102 in the comparison group [ adjusted hazard ratio = 1.19 ( 95 % CI : 0.91 - 1.55 ) ] . Analysis of food records showed that fat intake at baseline and after r and omization was not associated with total breast cancer incidence . Greater weight and lower carbohydrate intake at baseline and after r and omization were associated with an increased risk of estrogen receptor (ER)-positive breast cancer . Our findings suggest that a sustained reduction in dietary fat intake did not reduce risk of breast cancer in women with extensive mammographic density . Weight and carbohydrate intakes were associated with risk of ER-positive breast cancer Background Early life exposures , including diet , have been implicated in the etiology of breast cancer . Methods A nested case-control study was conducted among participants in the Nurses ' Health Study who completed a 24-item question naire about diet during high school . There were 843 eligible cases diagnosed between onset of study ( 1976 ) and before the return of the high school diet question naire ( 1986 ) , who were matched 10:1 with controls on the basis of age . Results Women who had , during adolescence , a higher consumption of eggs , vegetable fat and fiber had a lower risk of breast cancer , whereas risk of breast cancer was increased among women who consumed more butter . Conclusions A possible association of elements of adolescent diet with risk of breast cancer is reported , but the findings require confirmation in prospect i ve study The objective of this study was to evaluate the prospect i ve associations between dietary glycemic index ( GI ) and glycemic load ( GL ) and the risk for invasive breast cancer incidence in postmenopausal women at high cardiovascular disease ( CVD ) risk . This study was conducted within the framework of the PREvención con DIeta MEDiterránea ( PREDIMED ) study , a nutritional intervention trial for primary cardiovascular prevention . We included 4010 women aged between 60 and 80 years who were initially free from breast cancer but at high risk for CVD disease . Dietary information was collected using a vali date d 137-item food frequency question naire . We assigned GI values using the International Tables of GI and GL values . Cases were ascertained through yearly consultation of medical records and through consultation of the National Death Index . Only cases confirmed by results from cytology tests or histological evaluation were included . We estimated multivariable-adjusted hazard ratios for invasive breast cancer risk across tertiles of energy-adjusted dietary GI/GL using Cox regression models . We repeated our analyses using yearly repeated measures of GI/GL intakes . No associations were found between baseline dietary GI/GL and invasive breast cancer incidence . The multivariable hazard ratio and 95 % confidence interval ( CI ) for the top tertile of dietary GI was 1.02 ( 95 % CI : 0.42–2.46 ) and for dietary GL was 1.00 ( 95 % CI : 0.44–2.30 ) when compared with the bottom tertile . Repeated- measures analyses yielded similar results . In sensitivity analyses , no significant associations were observed for women with obesity or diabetes . Dietary GI and GL did not appear to be associated with an increased risk for invasive breast cancer in postmenopausal women at high CVD risk BACKGROUND Recent prospect i ve data suggest that intake of rapidly digested and absorbed carbohydrates with a high dietary glycemic load is associated with an increased risk of ischemic heart disease . OBJECTIVE We examined whether a high dietary glycemic load was associated with elevated hs-CRP concentrations and whether this association was modified by body mass index ( BMI ; in kg/m(2 ) ) . DESIGN In 244 apparently healthy women , we measured plasma hs-CRP concentrations and determined average dietary glycemic loads with a vali date d semiquantitative food-frequency question naire . Using multiple regression models , we evaluated the association between dietary glycemic load and plasma hs-CRP after adjusting for age ; treatment status ; smoking status ; BMI ; physical activity level ; parental history of myocardial infa rct ion ; history of hypertension , diabetes , and high cholesterol ; postmenopausal hormone use ; alcohol intake ; and other dietary variables . RESULTS We found a strong and statistically significant positive association between dietary glycemic load and plasma hs-CRP . The median hs-CRP concentration for the lowest quintile of dietary glycemic load was 1.9 mg/L and for the highest quintile was 3.7 mg/L ; corresponding multivariate-adjusted geometric means were 1.4 and 3.8 mg/L , respectively ( P for trend < 0.01 ) . This association was significantly modified by BMI . Among women with a BMI greater-than-or-equal 25 , the multivariate-adjusted geometric mean hs-CRP concentration in the lowest quintile was 1.6 mg/L and in the highest quintile was 5.0 mg/L ; however , among women with a BMI < 25 , the corresponding means were 1.1 and 3.1 mg/L , respectively ( P = 0.01 for interaction ) . CONCLUSIONS Dietary glycemic load is significantly and positively associated with plasma hs-CRP in healthy middle-aged women , independent of conventional risk factors for ischemic heart disease . Exacerbation of the proinflammatory process may be a mechanism whereby a high intake of rapidly digested and absorbed carbohydrates increases the risk of ischemic heart disease , especially in overweight women prone to insulin resistance BACKGROUND Diets high in carbohydrates may result in chronically elevated insulin concentrations and may affect breast cancer risk by stimulation of insulin receptors or through insulin-like growth factor I (IGF-I)-mediated mitogenesis . Insulin response to carbohydrate intake is increased in insulin-resistant states such as obesity . OBJECTIVE We sought to evaluate carbohydrate intake , glycemic index ( GI ) , and glycemic load ( GL ) and subsequent overall and hormone-receptor-defined breast cancer risk among postmenopausal women . DESIGN A prospect i ve cohort analysis of dietary carbohydrate and fiber intakes was conducted among 62 739 postmenopausal women from the E3N French study who had completed a vali date d dietary history question naire in 1993 . During a 9-y period , 1812 cases of pathology-confirmed breast cancer were documented through follow-up question naires . Nutrients were categorized into quartiles and energy-adjusted with the regression-residual method . Cox model-derived relative risks ( RRs ) were adjusted for known determinants in breast cancer . RESULTS Dietary carbohydrate and fiber intakes were not associated with overall breast cancer risk . Among overweight women , we observed an association between GI and breast cancer ( RR(Q1-Q4 ) : 1.35 ; 95 % CI : 1.00 , 1.82 ; P for trend = 0.04 ) . For women in the highest category of waist circumference , the RR(Q1-Q4 ) was 1.28 ( 95 % CI : 0.98 , 1.67 ; P for trend = 0.10 ) for carbohydrates , 1.35 ( 95 % CI : 1.04 , 1.75 ; P for trend = 0.01 ) for GI , and 1.37 ( 95 % CI : 1.05 , 1.77 ; P for trend = 0.003 ) for GL . We also observed a direct association between carbohydrate intake , GL , and estrogen receptor-negative breast cancer risk . CONCLUSIONS Rapidly absorbed carbohydrates are associated with postmenopausal breast cancer risk among overweight women and women with large waist circumference . Carbohydrate intake may also be associated with estrogen receptor-negative breast cancer BACKGROUND Limited scientific evidence has characterized the association between dietary fiber intake and risk of breast cancer ( BC ) by menopausal status and hormone receptor expression in tumors . OBJECTIVE We investigated the relation between total dietary fiber and its main food sources ( vegetables , fruit , cereals , and legumes ) and BC risk by using data from the European Prospect i ve Investigation into Cancer and Nutrition ( EPIC ) . DESIGN A total of 11,576 invasive BC cases in 334,849 EPIC women mostly aged 35 - 70 y at baseline were identified over a median follow-up of 11.5 y. Dietary fiber was estimated from country-specific dietary question naires . Multivariable Cox proportional hazards regression models were used to quantify the association between dietary variables and BC risk with energy adjustment by using the residual method . Subgroup analyses were performed by menopausal status and estrogen receptor ( ER ) and progesterone receptor ( PR ) expression in tumors . RESULTS BC risk was inversely associated with intakes of total dietary fiber [ hazard ratio comparing fifth quintile to first quintile ( HR(Q5-Q1 ) ) : 0.95 ; 95 % CI : 0.89 , 1.01 ; P-trend = 0.03 ] and fiber from vegetables ( 0.90 ; 0.84 , 0.96 ; P-trend < 0.01 ) but not with fiber from fruit , cereals , or legumes . Overall , associations were homogeneous by menopausal status and ER and PR expression in tumors . For vegetable fiber , stronger associations were observed for estrogen receptor-negative and progesterone receptor-negative ( HR(Q5-Q1):0.74 ; 95 % CI : 0.59 , 0.93 ; P-trend = 0.01 ) than for estrogen receptor-positive and progesterone receptor-positive tumors ( 0.92 : 0.81 , 1.03 ; P-trend = 0.05 ) , with P-heterogeneity = 0.09 . CONCLUSION Diets rich in dietary fiber and , particularly , fiber from vegetables may be associated with a small reduction in risk of BC , independently of menopausal status BACKGROUND The glycemic potential of a diet is associated with chronically elevated insulin concentrations , which may augment breast cancer ( BC ) risk by stimulating insulin receptor or by affecting insulin-like growth factor I (IGF-I)-mediated mitogenesis . It is unclear whether this effect differs by BC phenotype . OBJECTIVE The objective was to investigate the relation between glycemic index ( GI ) , glycemic load ( GL ) , and total carbohydrate intake with BC by using data from the European Prospect i ve Investigation into Cancer and Nutrition ( EPIC ) . DESIGN We identified 11,576 women with invasive BC among 334,849 EPIC women aged 34 - 66 y ( 5th to 95th percentiles ) at baseline over a median follow-up of 11.5 y. Dietary GI and GL were calculated from country-specific dietary question naires . We used multivariable Cox proportional hazards models to quantify the association between GI , GL , and carbohydrate intake and BC risk . BC tumors were classified by receptor status . RESULTS Overall GI , GL , and carbohydrates were not related to BC . Among postmenopausal women , GL and carbohy date intake were significantly associated with an increased risk of estrogen receptor-negative ( ER(- ) ) BC when extreme quintiles ( Q ) were compared [ multivariable HR(Q5-Q1 ) ( 95 % CI ) = 1.36 ( 1.02 , 1.82 ; P-trend = 0.010 ) and HR(Q5-Q1 ) = 1.41 ( 1.05 , 1.89 ; P-trend = 0.009 ) , respectively ] . Further stratification by progesterone receptor ( PR ) status showed slightly stronger associations with ER(-)/PR(- ) BC [ HR(Q5-Q1 ) ( 95 % CI ) = 1.48 ( 1.07 , 2.05 ; P-trend = 0.010 ) for GL and HR(Q5-Q1 ) = 1.62 ( 1.15 , 2.30 ; P-trend = 0.005 ) for \n Output:\n " }, { "from": "agent", "value": "Conclusions : Menopausal and hormone receptor status , but not BMI , might be potential influencing factors for the associations between carbohydrate intake , glycemic index , glycemic load , and breast 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: BACKGROUND African American men with hypertension in low socioeconomic urban population s achieve poor rates of hypertension control and suffer early from its complications . METHODS In a r and omized clinical trial with 309 hypertensive urban African American men aged 21 to 54 years , we evaluated the effectiveness of a more intensive comprehensive educational-behavioral-pharmacologic intervention by a nurse practitioner-community health worker-physician ( NP/CHW/MD ) team and a less intensive education and referral intervention in controlling blood pressure ( BP ) and minimizing progression of left ventricular hypertrophy ( LVH ) and renal insufficiency . Changes in BP , left ventricular mass ( LVM ) , and serum creatinine from baseline to 36 months were compared between groups . RESULTS At 36 months , the mean systolic BP/diastolic BP change from baseline was -7.5/-10.1 mm Hg for the more intensive group and + 3.4/-3.7 mm Hg for the less intensive group ( P = .001 and .005 for between-group differences in systolic BP and diastolic BP , respectively ) . The proportion of men with controlled BP ( < 140/90 mm Hg ) was 44 % in the more intensive group and 31 % in the less intensive group ( P = .045 ) . The LVM was significantly lower in the more intensive group than in the less intensive group ( more intensive , 274 g ; less intensive , 311 g ; P = .004 ) . There was a trend toward slowing of the progression of renal insufficiency ( incidence of 50 % increase in serum creatinine ) in the more intensive group compared to the less intensive group ( more intensive , 5.2 % ; less intensive , 8.0 % ; P = .08 ) . CONCLUSIONS During 36 months , the more intensive intervention led to a lower BP and decreased progression of LVH in a sample of hypertensive young African American men Background — Secondary prevention by risk factor modification improves patient outcomes , yet it is often not achieved in clinical practice . Reasons for failure stem from challenges of prioritizing risk factor reduction and engaging patients in changing their behaviors . We hypothesize that a novel telemedicine intervention with tailored patient education could improve cardiovascular risk factors . Methods — To evaluate this intervention , we propose enrolling 450 patients with a recent myocardial infa rct ion and hypertension into a 3-arm r and omized , controlled trial . The first arm ( n=150 ) will receive home blood pressure ( BP ) monitors plus a nurse-delivered , telephone-based tailored patient education intervention and will be enrolled into HealthVault , a Microsoft electronic health record platform . The second arm ( n=150 ) will also receive BP monitors plus a tailored patient education intervention and be enrolled in HeartVault . However , the patient education intervention will be delivered by a Web-based program and will cover topics identical to those in the nurse-delivered intervention . Both arms will be compared with a control group receiving st and ard care ( n=150 ) . All participants will have an in-person assessment at baseline and at completion of the study , including st and ardized measurements of BP , LDL cholesterol , and glycosylated hemoglobin ( in diabetic subjects ) . The study design will allow assessment of a telephone-based , nurse-administered disease management program versus st and ard care . The main outcome of interest is the reduction in systolic BP in each intervention group compared with the control group at 12 months . Secondary outcomes assessed will include reductions in LDL cholesterol , body weight , and glycosylated hemoglobin , as well as adherence to evidence -based therapies and improvement in health behaviors . Conclusion — If successful in optimizing BP control , managing other coronary heart disease risk factors , and demonstrating a lower cost , the Web-based disease management tool has the potential to enhance coronary artery disease management , quality of care , and ultimately , patient outcomes . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00901277 OBJECTIVE : To evaluate the effectiveness of a community pharmacist-based home blood pressure ( BP ) monitoring program . DESIGN : Trial of a high-intensity ( HI ) versus low-intensity ( LI ) intervention r and omized in 12 community pharmacies . The HI intervention comprised 4 face-to-face visits with a trained pharmacist . Pharmacists provided patient-specific education about hypertension . Following the first and third visits , patients were provided with a home BP monitoring device and instructed to measure their BP at least once daily for the next month . Home BP readings were used by the pharmacists to develop treatment recommendations for the patient ’s physician . Recommendations were discussed with the physician and , if approved , implemented by the pharmacist . In the LI intervention , pharmacists measured patients BP in the pharmacy and referred them to their physician for evaluation . PARTICIPANTS : Patients with uncontrolled BP at baseline . MEASUREMENTS : The main outcomes were the differences in systolic and diastolic BP ( SBP and DBP ) from baseline to follow-up between the HI and LI patients . RESULTS : The study enrolled 125 patients , 64 in the HI and 61 in the LI group . From baseline , SBP declined 13.4 mmHg in the HI group and 9.0 mmHg in the LI group . At the final visit , the difference in SBP/DBP change between the HI and LI group was −4.5/−3.2 mmHg ( P=.12 for SBP and P=.03 for DBP ) . CONCLUSIONS : The HI intervention achieved a lower DBP and this model could be a strategy for patients with hypertension OBJECTIVE To compare the effectiveness of an evidence -based , systematic approach to hypertension care involving comanagement of patients by primary care physicians and clinical pharmacists versus usual care in reducing blood pressure in patients with uncontrolled hypertension . METHODS Patients in a staff model medical group with uncontrolled hypertension were r and omized to either a usual care ( UC ) or a physician-pharmacist comanagement ( PPCM ) group . All physicians in the study received both group and individual education and participated in the development of an evidence -based hypertension treatment algorithm . Physicians were then given the names of their patients whose medical records documented elevated blood pressures ( defined as systolic > or = 140 mm Hg and /or diastolic > or = 90 mm Hg for patients aged < 65 yrs , and systolic > or = 160 mm Hg and /or diastolic > or = 90 mm Hg for those aged > or = 65 yrs ) . Patients r and omized to the UC group were managed by primary care physicians alone . Those r and omized to the PPCM group were comanaged by their primary care physician and a clinical pharmacist , who provided patient education , made treatment recommendations , and provided follow-up . Blood pressure measurements , antihypertensive drugs , and visit costs/patient were obtained from medical records . RESULTS One hundred ninety-seven patients with uncontrolled hypertension participated in the study . Both PPCM and UC groups experienced significant reductions in blood pressure ( systolic -22 and -11 mm Hg , respectively , p < 0.01 ; diastolic -7 and -8 mm Hg , respectively , p < 0.01 ) . The reduction in systolic blood pressure was greater in the PPCM group after adjusting for differences in baseline blood pressure between the groups ( p < 0.01 ) . More patients achieved blood pressure control in the PPCM than in the UC group ( 60 % vs 43 % , p = 0.02 ) . Average provider visit costs/patient were higher in the UC than the PPCM group ( $ 195 vs $ 160 , p = 0.02 ) . CONCLUSIONS An evidence -based , systematic approach using physician-pharmacist comanagement for patients with uncontrolled hypertension result ed in improved blood pressure control and reduced average visit costs/patient BACKGROUND St and ard office-based approaches to controlling hypertension show limited success . Such suboptimal hypertension control reflects in part the absence of both an infrastructure for patient education and frequent , regular blood pressure ( BP ) monitoring . We tested the efficacy of a physician-directed , nurse-managed , home-based system for hypertension management with st and ardized algorithms to modulate drug therapy , based on patients ' reports of home BP . METHODS We r and omized out patients requiring drug therapy for hypertension according to the Joint National Committee on Prevention , Detection , Evaluation , and Treatment of High Blood Pressure ( JNC VI ) criteria to receive usual medical care only ( UC , n = 76 ) or usual care plus nurse care management intervention ( INT , n = 74 ) over a 6-month period . RESULTS Patients receiving INT achieved greater reductions in office BP values at 6 months than those receiving UC : 14.2 + /- 18.1 versus 5.7 + /- 18.7 mm Hg systolic ( P < .01 ) and 6.5 + /- 10.0 versus 3.4 + /- 7.9 mm Hg diastolic , respectively ( P < .05 ) . At 6 months , we observed one or more changes in drug therapy in 97 % of INT patients versus 43 % of UC patients , and 70 % of INT patients received two or more drugs versus 46 % of UC . Average daily adherence to medication , measured by electronic drug event monitors , was superior among INT subjects ( mean + /- SD , 80.5 % + /- 23.0 % ) than among UC subjects ( 69.2 + /- 31.1 % ; t(113 ) = 2.199 , P = .03 ) . There were no significant adverse drug reactions in either group . CONCLUSIONS Telephone-mediated nurse management can successfully address many of the systems-related and patient-related issues that limit pharmacotherapeutic effectiveness for hypertension BACKGROUND Telemedicine is a promising but largely unproven technology for providing case management services to patients with chronic conditions who experience barriers to access to care or a high burden of illness . METHODS The authors conducted a r and omized , controlled trial comparing telemedicine case management to usual care , with blinding of those obtaining outcome data , in 1,665 Medicare recipients with diabetes , aged 55 years or greater , and living in federally design ated medically underserved areas of New York State . The primary endpoints were HgbA1c , blood pressure , and low-density lipoprotein ( LDL ) cholesterol levels . RESULTS In the intervention group ( n = 844 ) , mean HgbA1c improved over one year from 7.35 % to 6.97 % and from 8.35 % to 7.42 % in the subgroup with baseline HgbA1c > or = 7 % ( n = 353 ) . In the usual care group ( n = 821 ) mean HgbA1c improved over one year from 7.42 % to 7.17 % . Adjusted net reductions ( one-year minus baseline mean values in each group , compared between groups ) favoring the intervention were as follows : HgbA1c , 0.18 % ( p = 0.006 ) , systolic and diastolic blood pressure , 3.4 ( p = 0.001 ) and 1.9 mm Hg ( p < 0.001 ) , and LDL cholesterol , 9.5 mg/dL ( p < 0.001 ) . In the subgroup with baseline HgbA1c > or = 7 % , net adjusted reduction in HgbA1c favoring the intervention group was 0.32 % ( p = 0.002 ) . Mean LDL cholesterol level in the intervention group at one year was 95.7 mg/dL. The intervention effects were similar in magnitude in the subgroups living in New York City and upstate New York . CONCLUSION Telemedicine case management improved glycemic control , blood pressure levels , and total and LDL cholesterol levels at one year of follow-up BACKGROUND A patient-centered medical home ( PCMH ) demonstration was undertaken at 1 healthcare system , with the goals of improving patient experience , lessening staff burnout , improving quality , and reducing downstream costs . Five design principles guided development of the PCMH changes to staffing , scheduling , point-of-care , outreach , and management . OBJECTIVE To report differences in patient experience , staff burnout , quality , utilization , and costs in the first year of the PCMH demonstration . STUDY DESIGN Prospect i ve before and after evaluation . METHODS Baseline ( 2006 ) and 12-month ( 2007 ) measures were compared . Patient and staff experiences were measured using surveys from a r and om sample of patients and all staff at the PCMH and 2 control clinics . Automated data were used to measure and compare change components , quality , utilization , and costs for PCMH enrollees versus enrollees at 19 other clinics . Analyses included multivariate regressions for the different outcomes to account for baseline case mix . RESULTS After adjusting for baseline , PCMH patients reported higher ratings than controls on 6 of 7 patient experience scales . For staff burnout , 10 % of PCMH staff reported high emotional exhaustion at 12 months compared with 30 % of controls , despite similar rates at baseline . PCMH patients also had gains in composite quality between 1.2 % and 1.6 % greater than those of other patients \n Output:\n " }, { "from": "agent", "value": "These findings have been demonstrated in several meta-analyses and systematic review s. These review s have generally found that team-based care can reduce systolic blood pressure by 4 - 10 mm Hg over usual care .\nFew cost-effectiveness analyses have been performed but generally have found favorable costs for team-based care when considering the potential to reduce morbidity and 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 Community-based approaches have been increasing in the effort to raise awareness and early detection for cancer and other chronic disease . However , many times , such interventions are tested in r and omized trials , become evidence -based , and then fail to reach further use in the community . Project HEAL ( Health through Early Awareness and Learning ) is an implementation trial that aims to compare two strategies of implementing evidence -based cancer communication interventions in African American faith-based organizations . Method This article describes the community-engaged process of transforming three evidence -based cancer communication interventions into a coherent , br and ed strategy for training community health advisors with two delivery mechanisms . Peer community health advisors receive training through either a traditional classroom approach ( with high technical assistance/support ) or a web-based training portal ( with low technical assistance/support ) . Results We describe the process , outline the intervention components , report on the pilot test , and conclude with lessons learned from each of these phases . Though the pilot phase showed feasibility , it result ed in modifications to data collection protocol s and team and community member roles and expectations . Conclusions Project HEAL offers a promising strategy to implement evidence -based interventions in community setting s through the use of technology . There could be wider implication s for chronic disease prevention and control Colorectal cancer screening has clear benefits in terms of mortality reduction ; however , it is still underutilized and especially among medically underserved population s , including African Americans , who also suffer a disproportionate colorectal cancer burden . This study consisted of a theory-driven ( health belief model ) spiritually based intervention aim ed at increasing screening among African Americans through a community health advisor-led educational series in 16 churches . Using a r and omized design , churches were assigned to receive either the spiritually based intervention or a nonspiritual comparison , which was the same in every way except that it did not contain spiritual/religious content and themes . Trained and certified peer community health advisors in each church led a series of two group educational sessions on colorectal cancer and screening . Study enrollees completed a baseline , 1-month , and 12-month follow-up survey at their churches . The interventions had significant pre – post impact on awareness of all four screening modalities , and self-report receipt of fecal occult blood test , flexible sigmoidoscopy , and colonoscopy . There were no significant study group differences in study outcomes , with the exception of fecal occult blood test utilization , whereas those in the nonspiritual intervention reported significantly greater pre – post change . Both of these community-engaged , theory-driven , culturally relevant approaches to increasing colorectal cancer awareness and screening appeared to have an impact on study outcomes . Although adding spiritual/religious themes to the intervention was appealing to the audience , it may not result in increased intervention efficacy OBJECTIVES Body and Soul was a collaborative effort among two research universities , a national voluntary agency ( American Cancer Society ) , and the National Institutes of Health to disseminate and evaluate under real-world conditions the impact of previously developed dietary interventions for African Americans . METHODS Body and Soul was constructed from two successful research -based interventions conducted in African-American churches . Components deemed essential from the prior interventions were combined , and then tested in a cluster r and omized-effectiveness trial . The primary outcome was fruit and vegetable intake measured with two types of food frequency question naires at baseline and 6-month follow-up . RESULTS At the 6-month follow-up , intervention participants showed significantly greater fruit and vegetable ( F&V ) intake relative to controls . Post-test differences were 0.7 and 1.4 servings for the 2-item and 17-item F&V frequency measures , respectively . Statistically significant positive changes in fat intake , motivation to eat F&V , social support , and efficacy to eat F&V were also observed . CONCLUSIONS The results suggest that research -based interventions , delivered collaboratively by community volunteers and a health-related voluntary agency , can be effectively implemented under real-world conditions BACKGROUND Using community-based participatory research ( CBPR ) as a guiding framework , a faith-based diet , nutrition and physical activity intervention for African Americans was implemented and evaluated as a small-scale r and omized trial . METHODS Five churches were recruited ( intervention=3 , control=2 ) , result ing in an enrolled sample of 106 adults ( intervention=74 , control=32 ) . The control group received a minimal intervention consisting of one educational workshop . The Living Well By Faith intervention group received a more intensive 8-week program . Classes were held twice a week and included educational workshops and exercise sessions . Both interventions were delivered at participating churches . Assessment s for program evaluation occurred at baseline and 2-month follow-up . These included weight , blood pressure , percent body fat , and physical fitness using the step test . RESULTS The sample was predominantly African American , female and well educated . At baseline , no significant differences between intervention and control groups were found for any of the primary endpoints . At 2-months follow up , the intervention group , compared to the control group , showed significant decreases in weight ( P<.02 ) , BMI ( P<.05 ) , and % body fat ( P<.03 ) , with a significant increase in physical fitness ( P<.02 ) . Systolic blood pressure also showed group differences in the predicted direction ( P=.10 ) . CONCLUSION This study provides an exemplar of CBPR . The results obtained are sufficiently promising to support more research involving similar interventions of longer duration and with longer-term follow-up for evaluation Objective . The authors tested the impact on cardiovascular risk profiles of African American women ages 40 years and older after one year of participation in one of three church-based nutrition and physical activity strategies : a st and ard behavioral group intervention , the st and ard intervention supplemented with spiritual strategies , or self-help strategies . Methods . Women were screened at baseline and after one year of participation . The authors analyzed intention-to-treat within group and between groups using a generalized estimating equations adjustment for intra-church clustering . Because spiritual strategies were added to the st and ard intervention by participants themselves , the results from both active groups were similar and , thus , combined for comparisons with the self-help group . Results . A total of 529 women from 16 churches enrolled . Intervention participants exhibited significant improvements in body weight ( −1.1 lbs ) , waist circumference ( −0.66 inches ) , systolic blood pressure ( −1.6 mmHg ) , dietary energy ( −117 kcal ) , dietary total fat ( −8 g ) , and sodium intake ( −145 mg ) . The self-help group did not . In the active intervention group , women in the top decile for weight loss at one year had even larger , clinical ly meaningful changes in risk outcomes ( −19.8 lbs ) . Conclusions . Intervention participants achieved clinical ly important improvements in cardiovascular disease risk profiles one year after program initiation , which did not occur in the self-help group . Church-based interventions can significantly benefit the cardiovascular health of African American women Physical activity ( PA ) is low among African American women despite awareness of its positive impact on health . Learning and Developing Individual Exercise Skills for a Better Life ( L.A.D.I.E.S. ) compares three strategies for increasing PA among African American women using a cluster r and omized , controlled trial . Underactive adult women from 30 churches ( n=15 participants /church ) were recruited . Churches were r and omized to a faith-based intervention , a non-faith based intervention , or an information only control group . Intervention groups will meet 25 times in group sessions with other women from their church over a 10-month period . Control group participants will receive st and ard educational material promoting PA . All participants will be followed for an additional 12 months to assess PA maintenance . Data will be collected at baseline , 10 , and 22 months . The primary outcome is PA ( steps/day , daily moderate-to-vigorous PA ) . We expect treatment effects indicating that assignment to either of the active interventions is associated with greater magnitude of change in PA compared to the control group . In exploratory analyses , we will test whether changes in the faith-based intervention group are greater than changes in the non-faith-based intervention group . L.A.D.I.E.S. focuses on a significant issue-increasing PA levels-in a segment of the population most in need of successful strategies for improving health . If successful , L.A.D.I.E.S. will advance the field by providing an approach that is successful for initiating and sustaining change in physical activity , which has been shown to be a primary risk factor for a variety of health outcomes , using churches as the point of delivery BACKGROUND Faith-based interventions using a community-based participatory approach hold promise for eliminating ethnic health disparities . This study evaluated the effects of a volunteer-led statewide program to increase physical activity among members of African-American churches . METHODS African Method ist Episcopal churches within six regions ( Conferences ) were r and omly assigned to receive training in the program immediately or 1 year later . A cohort of 20 r and omly selected churches and 571 members within them took part in telephone surveys at baseline ( May-September 2003 ) and 1 year ( May-August 2004 ) and 2 years later ( June-September 2005 ) . Primary outcomes were physical activity participation , meeting physical activity recommendations , and stage of readiness for physical activity change . Statistical analyses were completed in April 2006 . RESULTS Volunteers ( N=889 ) from 303 churches were trained . Among survey respondents , physical activity did not increase significantly over time , although 67 % were aware of the program . Program awareness was significantly related to all three physical activity outcomes and to fruit and vegetable consumption . Pastoral support was significantly associated with physical activity . CONCLUSIONS Although this intervention reached a large number of churches and created awareness of intervention components , no effects on physical activity behaviors were found . Potential reasons for the lack of significant effects are discussed Despite multidisciplinary efforts to control the nation 's obesity epidemic , obesity has persisted as one of the U.S. 's top public health problems , particularly among African Americans . Innovative approaches to address obesity that are sensitive to the unique issues of African Americans are needed . Thus , a faith-based weight-loss intervention using a community-based participatory research approach was developed , implemented , and evaluated with a rural African American faith community . A two-group , quasi-experimental , delayed intervention design was used , with church as the unit of assignment ( treatment n = 2 , control n = 2 ) and individual as the unit of observation ( treatment n = 36 , control n = 37 ) . Weekly small groups led by trained community members met for 8 weeks and emphasized healthy nutrition , physical activity , and faith 's connection with health . The mean weight loss of the treatment group was 3.60 ± 0.64 lbs . compared to the 0.59 ± 0.59-lb loss of the control group OBJECTIVE To examine the extent to which participants in a combined physical activity ( PA ) and dietary intervention achieved changes in multiple health behaviors . DESIGN Group r and omized trial ; includes only participants assigned to the intervention group only . SETTING Thirty-six churches in South Carolina . PARTICIPANTS Three hundred sixty African American church members . INTERVENTION A 15-month PA and dietary intervention , guided by the structural ecological model , targeting environmental ( i.e. , social , cultural , physical ) and organizational ( ie , policies , practice s ) changes within the church . MAIN OUTCOME MEASURES Self-reported PA , fruit and vegetable consumption , fat- , and fiber-related behaviors . ANALYSIS Change in each behavior was defined as unadjusted pretest-posttest improvement ≥ 0.20 of the baseline st and ard deviation . The total number and each combination of behaviors changed were calculated . RESULTS Up to 19 % changed no health behaviors as defined above , 31 % changed 1 health behavior , 31 % changed 2 health behaviors , 13 % changed 3 health behaviors , and 5 % changed all 4 of the targeted health behaviors . Combinations of multiple behavior change included PA and dietary behaviors , which suggests that both behaviors can be changed simultaneously . CONCLUSIONS AND IMPLICATION S Nearly half of participants changed at least 2 health behaviors . Faith-based interventions targeting environmental and organizational change can successfully change multiple behaviors , potentially leading to greater improvements in public health BACKGROUND African Americans are at increased risk for cardiovascular disease and cancer morbidity and mortality . Physical activity and healthy dietary practice s can reduce this risk . The church is a promising setting to address health disparities , and community-based participatory research is a preferred approach . OBJECTIVES Using a community-based participatory approach and the social ecologic model , the FAN trial aims to increase self-reported moderate-intensity physical activity and fruit and vegetable consumption and reduce blood pressure in African American church members . Secondary aims are to increase objective ly measured moderate-intensity physical activity and fiber/whole grain consumption and reduce fat consumption . DESIGN FAN is a group r and omized trial ( GRT ) with two levels of clustering : participants ( N=1279 ; n=316 accelerometer subgroup ) within church and church within church cluster . In the first wave , seven clusters including 23 churches were r and omized to an immediate intervention or delayed intervention . In subsequent waves , 51 churches were r and omized to an immediate or delayed intervention . METHODS Church committee members , pastors , and cooks participate in full-day trainings to learn how to implement physical activity and dietary changes in the church . Monthly mailings and technical assistance calls are delivered over the 15-month intervention . Members complete measurements at baseline and 15 months . A detailed process evaluation is included . SUMMARY FAN focuses on modifying the social , cultural , and policy environment in a faith-based setting . The use of a community-based participatory research approach , engagement of church leaders , inclusion of a detailed process evaluation , and a formal plan for sustainability and dissemination make FAN unique BACKGROUND Faith-based interventions hold promise for \n Output:\n " }, { "from": "agent", "value": "A systematic review of topic-specific faith-based health programs determined that health outcomes can be improved though faith-based health interventions ." } ]

[ { "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 Successful treatment of chronic HCV with peginterferon ( PEGIFN ) and ribavirin ( RVN ) is often limited by anemia . We performed the present study to determine if utilizing epoetin alpha ( EPO ) with or without a higher dose of RVN could enhance sustained virologic response ( SVR ) . We r and omized 150 treatment-naive patients with chronic HCV genotype 1 into 3 treatment groups : ( 1 ) PEGIFN alpha-2b ( 1.5 microg/kg/week ) + weight-based RVN ( WBR ) 13.3 mg/kg/day ( 800 to 1400 mg/day ) ; ( 2 ) PEGIFN alpha-2b + WBRVN + EPO ( 40,000 U/week ) ; or ( 3 ) PEGIFN alpha-2b + higher dose WBR 15.2 mg/kg/day ( 1000 to 1600 mg/day ) + EPO . We initiated EPO at the onset of therapy to maintain the hemoglobin between 12 and 15 g/dL. When required , we reduced RVN by 200-mg steps . African Americans compose 36 % of the population . A significantly smaller percentage of group 2 patients had a decline in hemoglobin to less than 10 g/dL ( 9 % versus 34 % ; P < 0.05 ) and required that the RVN dose be reduced ( 10 % versus 40 % ; P < 0.05 ) compared to group 1 patients . Despite this , SVR was similar in these groups ( 19 % to 29 % ) . SVR was significantly greater ( P < 0.05 ) in group 3 patients ( 49 % ) . This result ed from a significant decline ( P < 0.05 ) in relapse rate ; only 8 % versus 38 % for groups 1 and 2 . CONCLUSION We conclude that using EPO in all subjects at the initiation of PEGIFN and RVN treatment will not enhance SVR given the same starting dose of RVN . In contrast , a higher starting dose of RVN was associated with a lower relapse rate and higher rate of SVR BACKGROUND In patients with chronic infection with hepatitis C virus ( HCV ) genotype 1 , treatment with peginterferon alfa and ribavirin for 48 weeks results in rates of sustained virologic response of 40 to 50 % . Telaprevir is a specific inhibitor of the HCV serine protease and could be of value in HCV treatment . METHODS A total of 334 patients who had chronic infection with HCV genotype 1 and had not been treated previously were r and omly assigned to receive one of four treatments involving various combinations of telaprevir ( 1250 mg on day 1 , then 750 mg every 8 hours ) , peginterferon alfa-2a ( 180 microg weekly ) , and ribavirin ( dose according to body weight ) . The T12PR24 group ( 81 patients ) received telaprevir , peginterferon alfa-2a , and ribavirin for 12 weeks , followed by peginterferon alfa-2a and ribavirin for 12 more weeks . The T12PR12 group ( 82 patients ) received telaprevir , peginterferon alfa-2a , and ribavirin for 12 weeks . The T12P12 group ( 78 patients ) received telaprevir and peginterferon alfa-2a without ribavirin for 12 weeks . The PR48 ( control ) group ( 82 patients ) received peginterferon alfa-2a and ribavirin for 48 weeks . The primary end point , a sustained virologic response ( an undetectable HCV RNA level 24 weeks after the end of therapy ) , was compared between the control group and the combined T12P12 and T12PR12 groups . RESULTS The rate of sustained virologic response for the T12PR12 and T12P12 groups combined was 48 % ( 77 of 160 patients ) , as compared with 46 % ( 38 of 82 ) in the PR48 ( control ) group ( P=0.89 ) . The rate was 60 % ( 49 of 82 patients ) in the T12PR12 group ( P=0.12 for the comparison with the PR48 group ) , as compared with 36 % ( 28 of 78 patients ) in the T12P12 group ( P=0.003 ; P=0.20 for the comparison with the PR48 group ) . The rate was significantly higher in the T12PR24 group ( 69 % [ 56 of 81 patients ] ) than in the PR48 group ( P=0.004 ) . The adverse events with increased frequency in the telaprevir-based groups were pruritus , rash , and anemia . CONCLUSIONS In this phase 2 study of patients infected with HCV genotype 1 who had not been treated previously , one of the three telaprevir groups had a significantly higher rate of sustained virologic response than that with st and ard therapy . Response rates were lowest with the regimen that did not include ribavirin . ( Clinical Trials.gov number , NCT00372385 . Background The conventional antiviral treatment of chronic hepatitis related to hepatitis C virus ( HCV ) often leads to anemia . In this case , it is necessary to reduce ribavirin dose or stop treatment , thus reducing the rate of sustained virological response . Aim We investigated whether epoetin alpha administration improves treatment adherence and leads to higher percentage of response at the end of therapy and sustained virological response . Methods Two hundred and fourteen individuals with genotype 1b HCV-related chronic hepatitis underwent treatment with pegylated (peg)-interferon alpha-2A 180 μg once weekly and ribavirin 1,000–1,200 mg/day ; 174 were responders . Forty individuals completed treatment with no hemoglobin reduction ; 134 developed anemia during therapy . Anemic responders were distributed r and omly into two groups : group 1 continued therapy with epoetin alpha addiction ; group 2 continued antiviral therapy with ribavirin reduction only . Results Patients in group 1 achieved better control of hemoglobin levels ( 13.8 ± 1.2 g/dl at the end of therapy ) than tthose in group 2 ( 11.5 ± 0.8 g/dl ) . Sustained virological response was 59.7 % in group 1 compared with 34.4 % in group 2 ( p < 0.01 ) . Conclusions In patients with 1b HCV-related chronic hepatitis who develop anemia during antiviral treatment , administration of epoetin alpha increases hemoglobin levels and the end-of-treatment rate and sustains virological response by improving treatment adherence BACKGROUND In patients with chronic infection with hepatitis C virus ( HCV ) genotype 1 who do not have a sustained response to therapy with peginterferon-ribavirin , outcomes after retreatment are suboptimal . Boceprevir , a protease inhibitor that binds to the HCV nonstructural 3 ( NS3 ) active site , has been suggested as an additional treatment . METHODS To assess the effect of the combination of boceprevir and peginterferon-ribavirin for retreatment of patients with chronic HCV genotype 1 infection , we r and omly assigned patients ( in a 1:2:2 ratio ) to one of three groups . In all three groups , peginterferon alfa-2b and ribavirin were administered for 4 weeks ( the lead-in period ) . Subsequently , group 1 ( control group ) received placebo plus peginterferon-ribavirin for 44 weeks ; group 2 received boceprevir plus peginterferon-ribavirin for 32 weeks , and patients with a detectable HCV RNA level at week 8 received placebo plus peginterferon-ribavirin for an additional 12 weeks ; and group 3 received boceprevir plus peginterferon-ribavirin for 44 weeks . RESULTS A total of 403 patients were treated . The rate of sustained virologic response was significantly higher in the two boceprevir groups ( group 2 , 59 % ; group 3 , 66 % ) than in the control group ( 21 % , P<0.001 ) . Among patients with an undetectable HCV RNA level at week 8 , the rate of sustained virologic response was 86 % after 32 weeks of triple therapy and 88 % after 44 weeks of triple therapy . Among the 102 patients with a decrease in the HCV RNA level of less than 1 log(10 ) IU per milliliter at treatment week 4 , the rates of sustained virologic response were 0 % , 33 % , and 34 % in groups 1 , 2 , and 3 , respectively . Anemia was significantly more common in the boceprevir groups than in the control group , and erythropoietin was administered in 41 to 46 % of boceprevir-treated patients and 21 % of controls . CONCLUSIONS The addition of boceprevir to peginterferon-ribavirin result ed in significantly higher rates of sustained virologic response in previously treated patients with chronic HCV genotype 1 infection , as compared with peginterferon-ribavirin alone . ( Funded by Schering-Plough [ now Merck ] ; HCV RESPOND-2 Clinical Trials.gov number , NCT00708500 . ) Pegylated interferon ( peg‐IFN ) and ribavirin ( RBV ) are effective in eradicating the hepatitis C virus in more than half of patients . However , anemia arising from RBV‐induced hemolysis can prompt dose reductions and lower sustained virologic response ( SVR ) rates . In early clinical trials , Viramidine ( VRD , renamed taribavirin ) , an RBV prodrug , was associated with less anemia and VRD given at 600 mg twice daily ( BID ) appeared to provide the best safety with comparable efficacy to RBV . The phase III Viramidine 's Safety and Efficacy versus Ribavirin 1 ( ViSER1 ) study r and omized 972 treatment‐naïve patients with chronic hepatitis C to fixed‐dose VRD ( 600 mg BID ) or weight‐based RBV ( 1000 or 1200 mg/day ) , each given with peg‐IFN alfa‐2b at 1.5 μg/kg/week . The primary efficacy endpoint was SVR rate , and the primary safety endpoint was hemoglobin ( Hb ) event rate ( percent of patients with Hb < 10 g/dL or at least a 2.5‐g/dL decrease from baseline ) . SVR rates were 37.7 % with VRD ( 244/647 ) and 52.3 % with RBV ( 170/325 ) . Thus , the ViSER1 study failed to demonstrate the primary noninferiority efficacy endpoint . Significantly fewer patients had Hb events with VRD ( 353/647 ; 54.6 % ) compared to those with RBV ( 272/325 ; 83.7 % ) ( P < 0.001 ) , and significantly fewer developed anemia ( Hb < 10 g/dL ) with VRD ( 34/647 ; 5.3 % ) compared to those with RBV ( 76/325 ; 23.5 % ) ( P < 0.001 ) . Conclusion : Fixed doses of VRD failed to demonstrate noninferiority to RBV in producing SVR rates . The incidence of anemia was approximately four‐fold significantly lower with VRD than with RBV . These results suggest fixed‐dose VRD given 600 mg BID is insufficient to treat patients with chronic hepatitis C ; a weight‐based dosing trial of viramidine is currently under way . ( HEPATOLOGY 2009 . Dose reductions of pegylated interferon alpha and ribavirin may be avoided by using growth factors . This phase II clinical trial assesses the dose , efficacy and safety of darbepoetin alpha and filgrastim for treatment of anaemia and neutropenia associated with combination therapy for hepatitis C virus ( HCV ) . Chronic hepatitis C patients ( n = 101 ) received pegylated interferon alpha-2b ( 1.5 mug/kg once weekly ) and ribavirin ( 800 - 1400 mg once daily ) . Patients with anaemia [ haemoglobin ( Hb ) < /= 10.5 g/dL ] received darbepoetin alpha ( 3 mug/kg once every 2 weeks ) ; the dose was titrated to achieve a Hb level of 12.0 g/dL. Patients with neutropenia [ absolute neutrophil count ( ANC ) < /= 0.75 x 10(9)/L ] received filgrastim with the dose titrated from 150 mug QW to 300 mug thrice weekly to maintain ANC > /= 0.75 x 10(9)/L and < 10 x 10(9)/L. During antiviral therapy , 52 % of patients required darbepoetin alpha , filgrastim or both . Hb at the time of darbepoetin alpha initiation was 10.2 + \n Output:\n " }, { "from": "agent", "value": "Ribavirin dose reductions have been recommended in the package inserts for the pegylated interferon products and studies have demonstrated the need for maintenance of 80 % of the initial ribavirin dose to achieve optimal sustained virologic response ( SVR ) with dual therapy .\nThe use of erythropoietin-stimulating agents has been shown to be effective for anemia caused by peginterferon and ribavirin without compromising SVR rates .\nLimited data have been published regarding the management of anemia with triple therapy ; however , efficacy studies for boceprevir and telaprevir have used ribavirin dose reduction and erythropoietin-stimulating agents to successfully manage anemia .\nCONCLUSIONS : Anemia is a common adverse event associated with the use of ribavirin , and , more recently , the new HCV protease inhibitors ." } ]

[ { "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: An intervention program was undertaken to assess dietary habits and the impact of nutrition education among pregnant women in the rural county of Florina , northern Greece . Analysis of dietary habits , nutrient intake , hemoglobin , and serum vitamin concentrations in an intervention and control group indicated that the population was adequately nourished although nutrient intake was below recommended levels for pregnant women . Nutrition counseling was associated with improvements in dietary intake and significantly greater maternal weight gain ( p less than 0.05 ) . Mean birth weight was slightly higher in the intervention group but so was the incidence of low birth weight ( 4.5 % vs 3.9 % ) . The prematurity rate was marginally lower in the intervention group ( p less than 0.04 ) , as was the number of perinatal deaths ( 9 vs 11 ) . The results indicate that nutrition counseling during pregnancy can improve dietary intake and maternal weight gain but the mediating influence on low frequency pregnancy outcomes is indeterminate in a population that is not nutritionally at risk OBJECTIVE : To determine whether group prenatal care improves pregnancy outcomes , psychosocial function , and patient satisfaction and to examine potential cost differences . METHODS : A multisite r and omized controlled trial was conducted at two university-affiliated hospital prenatal clinics . Pregnant women aged 14–25 years ( n=1,047 ) were r and omly assigned to either st and ard or group care . Women with medical conditions requiring individualized care were excluded from r and omization . Group participants received care in a group setting with women having the same expected delivery month . Timing and content of visits followed obstetric guidelines from week 18 through delivery . Each 2-hour prenatal care session included physical assessment , education and skills building , and support through facilitated group discussion . Structured interviews were conducted at study entry , during the third trimester , and postpartum . RESULTS : Mean age of participants was 20.4 years ; 80 % were African American . Using intent-to-treat analyses , women assigned to group care were significantly less likely to have preterm births compared with those in st and ard care : 9.8 % compared with 13.8 % , with no differences in age , parity , education , or income between study conditions . This is equivalent to a risk reduction of 33 % ( odds ratio 0.67 , 95 % confidence interval 0.44–0.99 , P=.045 ) , or 40 per 1,000 births . Effects were strengthened for African-American women : 10.0 % compared with 15.8 % ( odds ratio 0.59 , 95 % confidence interval 0.38–0.92 , P=.02 ) . Women in group sessions were less likely to have suboptimal prenatal care ( P<.01 ) , had significantly better prenatal knowledge ( P<.001 ) , felt more ready for labor and delivery ( P<.001 ) , and had greater satisfaction with care ( P<.001 ) . Breastfeeding initiation was higher in group care : 66.5 % compared with 54.6 % , P<.001 . There were no differences in birth weight nor in costs associated with prenatal care or delivery . CONCLUSION : Group prenatal care result ed in equal or improved perinatal outcomes at no added cost . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT00271960 LEVEL OF EVIDENCE : OBJECTIVE To evaluate the impact of a sustained , community-based collaborative approach to antenatal care services for Indigenous women . DESIGN Prospect i ve quality improvement intervention , the Mums and Babies program , in a cohort of women attending Townsville Aboriginal and Isl and ers Health Service , 1 January 2000 - 31 December 2005 ( MB group ) , compared with a historical control group ( PreMB group ) , 1 January 1998 - 30 June 1999 . MAIN OUTCOME MEASURES Proportion of women having inadequate antenatal care and screening ; perinatal indicators . RESULTS The number of antenatal visits per pregnancy increased from three ( interquartile range [ IQR ] , two to six ) in the PreMB group to six ( IQR , four to ten ) in the MB group ( P < 0.001 ) . There were significant improvements in care planning , completion of cycle-of-care , and antenatal education activities throughout the study period . About 90 % of all women attending for antenatal care were screened for sexually transmitted diseases , 89 % had measurement of haemoglobin level , and serological tests for hepatitis B and syphilis ( minimum antenatal screening ) . There was increased attendance for dating and morphology scans . In the MB group compared with the PreMB group , there was a significant reduction in perinatal mortality ( 14 v 60 per 1000 births ; P = 0.014 ) . CONCLUSION Sustained access to a community-based , integrated , shared antenatal service has improved perinatal outcomes among Indigenous women in Townsville OBJECTIVE : To determine whether engaging pregnant substance abusers in an integrated program of prenatal care and substance abuse treatment would improve neonatal outcomes . STUDY DESIGN : The subjects were women who voluntarily enrolled in Project Link , an intensive outpatient substance abuse treatment program at Women and Infants Hospital , Providence , RI . A total of 87 women received substance abuse treatment in conjunction with their prenatal care ; the comparison group of 87 women received equivalent prenatal care but did not enroll in the substance abuse treatment program until after they delivered . The two groups of women were similar demographically and socioeconomically and had similar substance abuse histories . Univariate and multivariate analyses were performed . The key outcomes were gestational age at delivery , birth weight , preterm delivery , Apgar scores , and neonatal intensive care admission rate . Factors controlled in the multivariate models included demographics , socioeconomic status , parity , and prenatal care . RESULTS : Infants born to women who enrolled prenatally were 400 gm heavier ( p < 0.001 ) , and their gestational age was 2 weeks longer ( p < 0.001 ) than infants of mothers enrolled postpartum . In addition , they were approximately one-third as likely to be born with a low birth weight ( p < 0.01 ) and approximately one-half as likely to be admitted to the neonatal intensive care unit ( p < 0.05 ) . CONCLUSION : Neonatal outcome is significantly improved for infants born to substance abusers who receive substance abuse treatment concurrent with prenatal care compared with infants born to substance abusers who enter treatment postpartum OBJECTIVES To evaluate the impact of a community-based , collaborative , shared antenatal care intervention ( the Mums and Babies program ) for Indigenous women in Townsville . DESIGN AND PARTICIPANTS Prospect i ve cohort study of women attending Townsville Aboriginal and Isl and er Health Service ( TAIHS ) for shared antenatal care with a singleton Indigenous birth between 1 January 2000 and 31 December 2003 ( 456 women ; the MB group ) , compared with a historical control group of 84 women who attended TAIHS for antenatal care before the intervention between 1 January 1998 and 30 June1999 , and a contemporary control group of 540 women who had a singleton birth at Townsville Hospital between 1 January 2000 and 30 June 2003 , but did not attend TAIHS for antenatal care . INTERVENTION Integration of previously autonomous service providers delivering shared antenatal care from TAIHS . MAIN OUTCOME MEASURES Patterns of antenatal visits , proportion of women undertaking key antenatal screening , and perinatal outcomes . RESULTS The number of Indigenous women who entered the MB program and gave birth at Townsville Hospital rose from 23.8 % in 2000 to 61.2 % in 2003 . The number of antenatal care visits per pregnancy increased from three ( interquartile [ IQ ] range , 2 - 6 ) in the historical control group to seven ( IQ range , 4 - 10 ) in the MB group ( P < 0.001 ) . 88 % of women in the MB group had at least one ultrasound . About 90 % of all women attending for antenatal care were screened for sexually transmitted infections . In the MB group , there was a significant reduction in preterm births compared with the contemporary control group ( 8.7 % v 14.3 % , P < 0.01 ) . There was no significant reduction in the prevalence of low birthweight births or perinatal mortality . CONCLUSION A community-based collaborative approach to shared antenatal care services increased access to antenatal care and was associated with fewer preterm births among Indigenous women in Townsville . The model may be adaptable in other urban centres with multiple antenatal care providers and significant numbers of Indigenous people across Australia Epidemiological evidence about the accuracy of diagnostic tests , the power of prognostic markers , and the efficacy and safety of interventions is the cornerstone of evidence -based health care.1 Practitioners of evidence -based health care require critical appraisal skills to judge the validity of this evidence . The Evidence -Based Medicine ( EBM ) Working Group members are international leaders in teaching critical appraisal skills , and their users ’ guides for appraising the validity of the healthcare literature 2 have long been the basis of teaching programmes worldwide . However , we found that many of our students took a reductionist “ paint by numbers ” approach when using the Working Group ’s guides . Students could answer individual appraisal questions correctly but would have difficulty assessing overall study quality . We believe this is due to a poor underst and ing of epidemiological study design . So over the past 15 years of teaching critical appraisal we have modified the EBM Working Group approach and developed the Graphic Appraisal Tool for Epidemiological studies ( GATE ) frame to help our students conceptualise the whole study as well as its component parts . GATE is a visual framework that illustrates the generic design of all epidemiological studies ( figure 1 ) . We now teach critical appraisal by “ hanging ” studies and the EBM Working Group ’s appraisal questions on the GATE frame . Figure 1 The GATE frame . This editorial outlines the GATE approach to critical appraisal , illustrated throughout using the Heart and Estrogen/progestin Replacement Study ( HERS ) , a r and omised , double blind , placebo controlled trial of the effect of daily oestrogen plus progestin on coronary heart disease ( CHD ) death in postmenopausal women.3 A detailed critical appraisal of HERS using a GATE-based checklist is available online.4 The GATE frame incorporates a triangle , circle , square , and arrow ( figure 1 ) , labelled with the acronym PECOT ( or PICOT ) . The triangle ( figure 2 ) represents the population studied : “ P ” for population or OBJECTIVES To determine the extent to which birth weight can be increased and the risk for adverse pregnancy outcome decreased when pregnant adolescents participated in the Higgins Nutrition Intervention Program ; and to describe the dietary components of the program , including their variation as a function of diagnosed risk for adverse pregnancy outcome . DESIGN Retrospective cohort study involving review of medical charts . SUBJECTS/ SETTING Developed as an adjunct to routine prenatal care , the Higgins Nutrition Intervention Program consists of an assessment of each pregnant adolescent 's risk profile for adverse pregnancy outcomes and an individualized nutritional rehabilitation program based on that profile . The intervention group for this evaluation consisted of 1,203 pregnant adolescents who participated in the Higgins program at the Montreal Diet Dispensary between 1981 and 1991 . The nonintervention group consisted of a r and omly selected group of 1,203 pregnant adolescents known not to have participated in the program . OUTCOMES MEASURED Birth weight ; rates of low birth weight , very low birth weight , preterm delivery , fetal growth retardation , perinatal morbidity and mortality ; and maternal morbidity . STATISTICAL ANALYSIS Means and proportions were used to describe risk profiles and pregnancy outcomes in the two groups . Analysis of covariance and logistic regression were used to compare pregnancy outcomes while controlling for the effect of key confounding variables . RESULTS Results from multivariable analyses showed that infants in the intervention group weighed an average of 55 g more ( P < .05 ) than infants in the nonintervention group ; their low-birth-weight rate was 39 % lower ( P < .001 ) and their very-low-birth-weight rate was 56 % lower ( P < .01 ) . Individually determined dietary prescriptions for the adolescents in the intervention group recommended increases in daily consumption averaging approximately 900 kcal energy and 52 g protein . The lowest daily increases ( approximately 150 kcal energy and 2 g protein ) were recommended to the group with no diagnosed risks ; the greatest increases ( approximately 1,300 kcal energy and 76 g protein ) were recommended to the group with multiple risk conditions . Although none of the risk/intervention groups achieved their prescribed increases during intervention , increases in actual intake generally followed the pattern of the prescribed increases ; that is , the greater the prescribed increase , the greater the actual increase . CONCLUSIONS These results suggest that the Higgins Nutrition Intervention Program , in which nutrition intervention is individualized as a function of diagnosed risk , significantly improves the outcome of adolescent pregnancy OBJECTIVE The primary objective of this prospect i ve study was to test whether preterm birth prevention education plus increased clinic visits and selected prophylactic interventions reduce preterm birth . STUDY DESIGN Eight West Los Angeles prenatal county clinics , compar \n Output:\n " }, { "from": "agent", "value": "Conclusions There was insufficient evidence of adequate quality to recommend routine implementation of any of the programmes as a means of reducing infant mortality in disadvantaged/vulnerable women ." } ]

[ { "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: Recent guidelines on exercise for weight loss and weight maintenance include resistance training as part of the exercise prescription . Yet few studies have compared the effects of similar amounts of aerobic and resistance training on body mass and fat mass in overweight adults . STRRIDE AT/RT , a r and omized trial , compared aerobic training , resistance training , and a combination of the two to determine the optimal mode of exercise for obesity reduction . Participants were 119 sedentary , overweight or obese adults who were r and omized to one of three 8-mo exercise protocol s : 1 ) RT : resistance training , 2 ) AT : aerobic training , and 3 ) AT/RT : aerobic and resistance training ( combination of AT and RT ) . Primary outcomes included total body mass , fat mass , and lean body mass . The AT and AT/RT groups reduced total body mass and fat mass more than RT ( P < 0.05 ) , but they were not different from each other . RT and AT/RT increased lean body mass more than AT ( P < 0.05 ) . While requiring double the time commitment , a program of combined AT and RT did not result in significantly more fat mass or body mass reductions over AT alone . Balancing time commitments against health benefits , it appears that AT is the optimal mode of exercise for reducing fat mass and body mass , while a program including RT is needed for increasing lean mass in middle-aged , overweight/obese individuals OBJECTIVE : In epidemiological studies , weight loss is usually associated with increased mortality rate . Contrarily , among obese people , weight loss reduces other risk factors for disease and death . We hypothesised that this paradox could exist because weight is used as an implicit adiposity index . No study has considered the independent effects of weight loss and fat loss on mortality rate . We studied mortality rate as a function of weight loss and fat loss . DESIGN : Analysis of ‘ time to death ’ in two prospect i ve population -based cohort studies , the Tecumseh Community Health Study ( 1890 subjects ; 321 deaths within 16 y of follow-up ) and the Framingham Heart Study ( 2731 subjects ; 507 deaths within 8 y of follow-up ) , in which weight and fat ( via skinfolds ) loss were assessable . RESULTS : In both studies , regardless of the statistical approach , weight loss was associated with an increased , and fat loss with a decreased , mortality rate ( P<0.05 ) . Each st and ard deviation ( s.d . ) of weight loss ( 4.6 kg in Tecumseh , 6.7 kg in Framingham ) was estimated to increase the hazard rate by 29 % ( 95 % confidence interval CI ) , ( 14 % , 47 % , respectively ) and 39 % ( 95 % CI , 25 % , 54 % respectively ) , in the two sample s. Contrarily , each s.d . of fat loss ( 10.0 mm in Tecumseh , 4.8 mm in Framingham ) was estimated to reduce the hazard rate 15 % ( 95 % CI , 4 % , 25 % ) and 17 % ( 95 % CI , 8 % , 25 % ) in Tecumseh and Framingham , respectively . Generalisability of these results to severely ( that is , body mass index BMI ) ≥34 ) obese individuals is unclear . CONCLUSIONS : Among individuals that are not severely obese , weight loss is associated with increased mortality rate and fat loss with decreased mortality rate OBJECTIVE To correlate anthropometric , computed tomography and fat cell data from abdominal regions with the levels of serum insulin , C-peptide , leptin , tumor necrosis factor-alpha ( TNF-alpha ) , testosterone , 17beta-estradiol , and rostenedione , dehydroepi and rosterone sulphate ( DHEA-S ) and sex hormone-binding globulin ( SHBG ) . DESIGN AND METHODS The sample consisted of 84 obese patients ( 29 men , 22 premenopausal women and 33 postmenopausal women ) who had undergone abdominal surgery . Weight , height , percentage of body fat by skinfolds , waist , hip and thigh circumferences , sagittal and coronal diameters , visceral and subcutaneous area , serum hormones and fat cell data were studied . RESULTS AND CONCLUSIONS Premenopausal women showed the lowest values in most abdominal distribution parameters , although , depending on the waist circumference criteria at the umbilicus level perimeter ( W1 ) or midway between lower rib margin and iliac crest perimeter ( W2 ) , the population was classified differently , as gynoid or and roid . Although there were no differences in fat cell size between genders , gynoid women had smaller and more numerous fat cells than the and roid type . Perivisceral fat cell size was significantly smaller than subcutaneous fat cell size . In women , central obesity was significantly correlated with an increase in serum insulin , leptin , TNF-alpha , testosterone and and rostenedione levels , and a decrease in 17beta-estradiol and DHEA-S , while in men significant correlations were positive with insulin and negative with testosterone and and rostenedione . Fat cell size was positively correlated with serum levels of leptin , insulin , DHEA-S , and rostenedione and inversely correlated with SHBG . These data indicate that hormones seem to interact not only with body fat distribution but also with fat cell size . This interaction differs between genders and between the different abdominal adipose tissue regions This prospect i ve , r and omized study investigated the effect of exercise on leptin , insulin , cortisol and lipid profiles in obese children . A total of 40 obese boys aged 10 - 12 years with a body mass index ( BMI ) ≥ 30 kg/m2 were r and omly separated into an exercise group ( n = 20 ) that underwent a 12-week aerobic exercise programme and a non-exercise ( control ) group ( n = 20 ) . The BMI , low-density lipoprotein , cortisol , leptin and insulin levels were significantly lower in the exercise group after 12 weeks compared with baseline values , whereas high-density lipoprotein levels were significantly higher . In contrast , in the control group , low-density lipoprotein , cortisol and leptin levels were significantly higher after 12 weeks compared with baseline values while high-density lipoprotein levels were significantly lower . These findings indicate the importance of regular exercise in the regulation of body weight and protection against cardiovascular risk factors in obese children Abstract The effects of a recreational soccer program ( RSP ) upon body composition , heart rate variability ( HRV ) , biochemical markers , cardio-respiratory fitness , and endothelial function in obese adolescents were investigated . A r and omised controlled clinical trial was conducted with 30 adolescents aged 12–17 years and body mass index ( BMI ) > 2 st and ard deviations of WHO reference values , which were assigned to RSP ( n = 10 , 2 girls ) and obese control ( n = 10 , 4 girls ) groups . The 12-week RSP included 60-min sessions performed 3 times/week . BMI , waist circumference , blood pressure , blood glucose , lipid profile , insulin , C-reactive protein , HRV , and maximal oxygen consumption ( VO2peak ) were evaluated following st and ardised procedures . Body composition was determined by dual-energy X-ray absorptiometry and endothelial function by venous occlusion plethysmography . After intervention , RSP exhibited significant reductions in BMI ( −0.7 ± 0.2 kg · m–2 ) , waist circumference ( −8.2 ± 1.4 cm ) , % body fat ( −2.2 ± 0.4 % ) , systolic blood pressure ( −5.0 ± 2.3 mmHg ) , total cholesterol ( −16.2 ± 5.8 mg · dL−1 ) , triglycerides ( −20.5 ± 12.9 mg · dL−1 ) , C-reactive protein ( −0.06 ± 0.01 mg · dL−1 ) , insulin resistance ( HOMA-IR , −1.4 ± 0.6 ) , and sympathetic activity ( LF , −13.9 ± 6.6 un ) vs. controls ( P < 0.05 ) . Significant increase was observed in parasympathetic activity ( HF , 13.9 ± 6.6 un ) , VO2peak ( 7.9 ± 2.8 ml · kg−1 · min−1 ) , and high-density lipoprotein cholesterol ( 11.0 ± 6.3 mg · dL−1 ) ( P < 0.05 ) . Vascular conductance ( 19.5 ± 8.1 ml · min−1 · 100 ml , P = 0.005 ) increased and vascular resistance ( −5.9 ± 2.4 ml · min−1 · 100 ml , P = 0.041 ) decreased in RSP , but not in controls . A 12-week recreational soccer intervention was effective to improve biochemical , cardiovascular , and fitness health markers in obese adolescents \n Output:\n " }, { "from": "agent", "value": "These results indicate that physical exercise improved the inflammatory state in children with obesity .\nIt is unclear whether this effect can reduce the risk of cardiovascular and metabolic disease in adulthood ." } ]

[ { "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: Caring for stroke patients in stroke units , compared with other hospital locations , leads to decreased mortality and disability at one year.1 A trial of a combined acute and rehabilitation ward in Trondheim , Norway , showed that hospital care improved survival and functional outcome at five years.2 The benefits were attributed to the treatment provided in the first few weeks after stroke . The purpose of this study was to examine the effects of care in a non-acute stroke unit on outcome at five years . The methods and findings of 315 patients at one year of our r and omised study comparing a non-acute stroke rehabilitation unit with care on conventional medical and geriatric wards have been published.3 In the present study , we ascertained survival to five years by using hospital records and death certificates . Survivors were traced to establish their residential status and visited by a research er who was Background Hyperglycaemia , fever , and swallowing dysfunction are poorly managed in the admission phase of acute stroke , and patient outcomes are compromised . Use of evidence -based guidelines could improve care but have not been effectively implemented . Our study aims to develop and trial an intervention based on multidisciplinary team-building to improve management of fever , hyperglycaemia , and swallowing dysfunction in patients following acute stroke . Methods and design Metropolitan acute stroke units ( ASUs ) located in New South Wales , Australia will be stratified by service category ( A or B ) and , within strata , by baseline patient recruitment numbers ( high or low ) in this prospect i ve , multicentre , single-blind , cluster r and omised controlled trial ( C RCT ) . ASUs then will be r and omised independently to either intervention or control groups . ASUs allocated to the intervention group will receive : unit-based workshops to identify local barriers and enablers ; a st and ardised core education program ; evidence -based clinical treatment protocol s ; and ongoing engagement of local staff . Control group ASUs will receive only an abridged version of the National Clinical Guidelines for Acute Stroke Management . The following outcome measures will be collected at 90 days post-hospital admission : patient death , disability ( modified Rankin Score ) ; dependency ( Barthel Index ) and Health Status ( SF-36 ) . Additional measures include : performance of swallowing screening within 24 hours of admission ; glycaemic control and temperature control . Discussion This is a unique study of research transfer in acute stroke . Providing optimal inpatient care during the admission phase is essential if we are to combat the rising incidence of debilitating stroke . Our C RCT will also allow us to test interventions focussed on multidisciplinary ASU teams rather than individual disciplines , an imperative of modern hospital services . Trial Registration Australia New Zeal and Clinical Trial Registry ( ANZCTR ) No : BACKGROUND We assessed patient outcomes 90 days after hospital admission for stroke following a multidisciplinary intervention targeting evidence -based management of fever , hyperglycaemia , and swallowing dysfunction in acute stroke units ( ASUs ) . METHODS In the Quality in Acute Stroke Care ( QASC ) study , a single-blind cluster r and omised controlled trial , we r and omised ASUs ( clusters ) in New South Wales , Australia , with immediate access to CT and on-site high dependency units , to intervention or control group . Patients were eligible if they spoke English , were aged 18 years or older , had had an ischaemic stroke or intracerebral haemorrhage , and presented within 48 h of onset of symptoms . Intervention ASUs received treatment protocol s to manage fever , hyperglycaemia , and swallowing dysfunction with multidisciplinary team building workshops to address implementation barriers . Control ASUs received only an abridged version of existing guidelines . We recruited pre-intervention and post-intervention patient cohorts to compare 90-day death or dependency ( modified Rankin scale [ mRS ] ≥2 ) , functional dependency ( Barthel index ) , and SF-36 physical and mental component summary scores . Research assistants , the statistician , and patients were masked to trial groups . All analyses were done by intention to treat . This trial is registered at the Australia New Zeal and Clinical Trial Registry ( ANZCTR ) , number ACTRN12608000563369 . FINDINGS 19 ASUs were r and omly assigned to intervention ( n=10 ) or control ( n=9 ) . Of 6564 assessed for eligibility , 1696 patients ' data were obtained ( 687 pre-intervention ; 1009 post-intervention ) . Results showed that , irrespective of stroke severity , intervention ASU patients were significantly less likely to be dead or dependent ( mRS ≥2 ) at 90 days than control ASU patients ( 236 [ 42 % ] of 558 patients in the intervention group vs 259 [ 58 % ] of 449 in the control group , p=0·002 ; number needed to treat 6·4 ; adjusted absolute difference 15·7 % [ 95 % CI 5·8 - 25·4 ] ) . They also had a better SF-36 mean physical component summary score ( 45·6 [ SD 10·2 ] in the intervention group vs 42·5 [ 10·5 ] in the control group , p=0·002 ; adjusted absolute difference 3·4 [ 95 % CI 1·2 - 5·5 ] ) but no improvement was recorded in mortality ( 21 [ 4 % ] of 558 in intervention group and 24 [ 5 % ] of 451 in the control group , p=0·36 ) , SF-36 mean mental component summary score ( 49·5 [ 10·9 ] in the intervention group vs 49·4 [ 10·6 ] in the control group , p=0·69 ) or functional dependency ( Barthel Index ≥60 : 487 [ 92 % ] of 532 patients vs 380 [ 90 % ] of 423 patients ; p=0·44 ) . INTERPRETATION Implementation of multidisciplinary supported evidence -based protocol s initiated by nurses for the management of fever , hyperglycaemia , and swallowing dysfunction delivers better patient outcomes after discharge from stroke units . Our findings show the possibility to augment stroke unit care . FUNDING National Health & Medical Research Council ID 353803 , St Vincent 's Clinic Foundation , the Curran Foundation , Australian Diabetes Society-Servier , the College of Nursing , and Australian Catholic University BACKGROUND AND PURPOSE The efficacy of stroke units has been extensively examined . It is unknown , however , whether the superiority of the stroke unit will remain after the increased focus on stroke treatment in general medicine . This study of patients admitted to the hospital early and with a short length of stay determines the effect and identifies certain important components of a stroke unit . METHODS Five hundred fifty patients aged 60 years or older with acute stroke were allocated by a quasi-r and omized design to a stroke unit or a general medical ward based on date of birth in the month . Patients admitted within 24 hours of onset were enrolled . Outcomes after 7 months were death , proportion needing long-term care , and change in neurological and functional state assessed by the Sc and inavian Stroke Scale and Barthel Index . RESULTS Seven months after admission there was a trend in favor of the stroke unit in all outcome measures , but no significant differences in clinical outcomes were found except for change in the Sc and inavian Stroke Scale score . Recurrent stroke during hospitalization occurred more often in the general medical ward ( P = .03 ) . The stroke unit was significantly more aggressive in mobilization out of bed ( P<.01 ) and use of parenteral fluid ( P<.0001 ) , aspirin ( P<.0001 ) , antipyretics ( P<.0001 ) , and antibiotics ( P<.0001 ) . CONCLUSIONS Our study confirms the benefit of the stroke unit , but the effects on the most reliable clinical outcomes were modest and insignificant . Treatment in this stroke unit hastened recovery . More aggressive rehabilitation and use of parenteral fluid , aspirin , antipyretics , and antibiotics appeared in the stroke unit BACKGROUND AND PURPOSE We have previously shown that treatment in our combined acute and rehabilitation stroke unit ( SU ) improves the outcome during the first 5 years after onset of stroke compared with that for stroke patients treated in general wards ( GW ) . The aim of the present trial was to examine the effects of SU care after 10 years of follow-up . METHODS In a r and omized controlled trial , 110 patients with symptoms and signs of an acute stroke were allocated to the SU and 110 to GW . No significant differences existed in baseline characteristics between the groups . The outcome after 10 years was measured by the proportion of patients at home , the proportion of patients in an institution , the mortality , and the functional state as assessed by the Barthel Index , in which a Barthel Index score of > /=60 was classified as independent or partly independent and a score of > /=95 was classified as independent . RESULTS After 10 years , 21 ( 19.1 % ) of the patients r and omized to the SU and 9 ( 8.2 % ) of the patients r and omized to the GW were at home ( P=0.0184 ) . Eighty-three ( 75.5 % ) of the patients from the SU and 96 ( 87.3 % ) of the patients from the GW were dead ( P=0.0082 ) , and 6 ( 5.4 % ) and 5 ( 4.5 % ) , respectively , were in an institution ( eg , nursing home ; NS ) . Twenty-two ( 20.0 % ) of the SU patients and 9 ( 8 . 2 % ) of the GW patients had a Barthel Index score of > /=60 ( P=0.0118 ) , and 14 ( 12.7 % ) and 6 ( 5.4 % ) , respectively , had a score of > /=95 ( P=0.0606 ) . CONCLUSIONS For the first time it has been shown that SU care improves survival and functional state and increases the proportion of patients able to live at home 10 years after their stroke . Treatment in combined acute and rehabilitation SU seems to have important long-term effects on outcome for stroke patients In a prospect i ve controlled trial we compared the clinical outcome for unselected acute stroke patients in a non-intensive stroke unit ( n = 110 ) and in general medical wards ( n = 183 ) . The patients were comparable in age , marital state and functional impairment on admission . Case fatality rates over the first year after the stroke were similar in the two groups . By three months after the stroke , 15 % of the survivors initially admitted to the stroke unit and 39 % of those admitted to general medical wards remained hospitalized ( p less than 0.001 ) . The corresponding figures by one year after the cerebrovascular accident were 12 % and 28 % , respectively ( p less than 0.05 ) . A greater proportion of surviving stroke unit patients was independent in walking ( 0.10 greater than p greater than 0.05 ) , personal hygiene ( p less than 0.05 ) and dressing ( p less than 0.001 ) . Essential features of the stroke unit are team work headed by a stroke nurse , staff , patient and family education and very early onset of rehabilitation . We conclude that this strategy improves functional outcome and reduces the need for long-term hospital care BACKGROUND AND PURPOSE We have previously shown that treatment in our combined acute and rehabilitation Stroke Unit improves outcome during the first year after onset of stroke compared with stroke patients treated in general wards . The aim of the present trial was to examine the long-term effects of the stroke unit care . METHODS In a r and omized controlled trial , 110 patients with symptoms and signs of an acute stroke were allocated to the Stroke Unit and 110 to general wards . No significant differences existed in baseline characteristics between the two groups . The outcome after 5 years was measured by the proportion of patients at home , the proportion of patients in an institution , the mortality , and the functional state assessed by Barthel Index . RESULTS After 5 years , 38 ( 34.5 % ) of the patients r and omized to the Stroke Unit and 20 ( 18.2 % ) of the patients r and omized to the general wards were at home ( P = .006 ) . Sixty-five ( 59.1 % ) of the patients from the Stroke Unit and 78 ( 70.9 % ) of the patients from the general wards were dead ( P = .041 ) , while 7 ( 6.4 % ) and 12 ( 10.9 % ) , respectively , were in an institution ( e.g. , nursing home ) ( P = NS ) . Functional state was significantly better for patients treated in the Stroke Unit . CONCLUSIONS For the first time it is shown that stroke unit care improves long-term survival and functional state and increases the proportion of patients able to live at home 5 years after the stroke . Combined acute and rehabilitation stroke units appear to be an effective way of organizing treatment for acute stroke patients Background and Purpose — The benefits of stroke unit management may vary according to stroke subtype . A post hoc analysis of the influence of stroke subtype on stroke unit effectiveness was undertaken by using prospect i ve data collected in a r and omized controlled trial . Methods — Two hundred sixty-seven patients with moderately severe ischemic stroke ( 164 with large-vessel infa rcts and 103 with lacunar infa rcts ) were r and omly allocated to treatment in stroke units or in general medical wards with specialist stroke team support . Mortality , institutionalization , neurological , functional , and quality -of-life scores and re source use were assessed at 3 and again at 12 months after stroke onset . An intention-to-treat analysis was undertaken , and logistic regression was used to evaluate \n Output:\n " }, { "from": "agent", "value": "Outcomes appeared to be independent of patient age , sex , initial stroke severity , stroke type , and duration of follow-up .\nWe found moderate- quality evidence that stroke patients who receive organised inpatient ( stroke unit ) care are more likely to be alive , independent , and living at home one year after the stroke .\nThe apparent benefits were independent of patient age , sex , initial stroke severity , or stroke type , and were most obvious in units based in a discrete stroke ward .\nWe observed no systematic increase in the length of inpatient stay , but these findings had considerable uncertainty" } ]

[ { "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 The 2-year , phase III trial design ated Anti-vascular endothelial growth factor ( VEGF ) Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization ( CNV ) in Age-related Macular Degeneration ( ANCHOR ) compared ranibizumab with verteporfin photodynamic therapy ( PDT ) in treating predominantly classic CNV . DESIGN Multicenter , international , r and omized , double-masked , active-treatment-controlled clinical trial . PARTICIPANTS Patients with predominantly classic , subfoveal CNV not previously treated with PDT or antiangiogenic drugs . INTERVENTION Patients were r and omized 1:1:1 to verteporfin PDT plus monthly sham intraocular injection or to sham verteporfin PDT plus monthly intravitreal ranibizumab ( 0.3 mg or 0.5 mg ) injection . The need for PDT ( active or sham ) retreatment was evaluated every 3 months using fluorescein angiography ( FA ) . MAIN OUTCOME MEASURES The primary , intent-to-treat efficacy analysis was at 12 months , with continued measurements to month 24 . Key measures included the percentage losing < 15 letters from baseline visual acuity ( VA ) score ( month 12 primary efficacy outcome measure ) , percentage gaining > or=15 letters from baseline , and mean change over time in VA score and FA-assessed lesion characteristics . Adverse events were monitored . RESULTS Of 423 patients ( 143 PDT , 140 each in the 2 ranibizumab groups ) , the majority ( > or=77 % in each group ) completed the 2-year study . Consistent with results at month 12 , at month 24 the VA benefit from ranibizumab was statistically significant ( P<0.0001 vs. PDT ) and clinical ly meaningful : 89.9 % to 90.0 % of ranibizumab-treated patients had lost < 15 letters from baseline ( vs. 65.7 % of PDT patients ) ; 34 % to 41.0 % had gained > or=15 letters ( vs. 6.3 % of PDT group ) ; and , on average , VA was improved from baseline by 8.1 to 10.7 letters ( vs. a mean decline of 9.8 letters in PDT group ) . Changes in lesion anatomic characteristics on FA also favored ranibizumab ( all comparisons P<0.0001 vs. PDT ) . Overall , there was no imbalance among groups in rates of serious ocular and nonocular adverse events . In the pooled ranibizumab groups , 3 of 277 ( 1.1 % ) patients developed presumed endophthalmitis in the study eye ( rate per injection = 3/5921 [ 0.05 % ] ) . CONCLUSIONS In this 2-year study , ranibizumab provided greater clinical benefit than verteporfin PDT in patients with age-related macular degeneration with new-onset , predominantly classic CNV . Rates of serious adverse events were low . FINANCIAL DISCLOSURE(S ) Proprietary or commercial disclosure may be found after the references Purpose This prospect i ve multi-center pilot study compares the use of half-fluence photodynamic therapy combined with ranibizumab with ranibizumab monotherapy for the treatment of neovascular age-related macular degeneration . Methods All patients presenting with untreated subfoveal neovascular age-related macular degeneration were considered for inclusion . Patients were r and omized to receive either ranibizumab with half-fluence photodynamic therapy or ranibizumab alone . Patients in the ranibizumab alone group were given three consecutive monthly ranibizumab injections and were followed monthly . They were treated with ranibizumab as needed , based on clinical discretion , using vision and optical coherence tomography . Patients in the combined group were given one same-day combined ranibizumab and half-fluence ( 25 j/cm2 ) photodynamic therapy treatment and were treated monthly as needed . Outcomes included changes in st and ardized visual acuity , optical coherence tomography foveal thickness , and percentage of as-needed injections to maintenance examinations . Results Fifty-six out of 60 enrolled patients completed the twelve month primary outcome visit ; this consisted of 27 patients receiving ranibizumab alone and 29 receiving combined treatment . The average age was 79.1 for the ranibizumab alone group and 79.3 for the combined group . The mean visual acuity in the ranibizumab alone group improved from 52.9 Early Treatment of Diabetic Retinopathy letters initially to 62.8 letters at twelve months . The mean visual acuity in the combined group improved from 49.2 letters to 51.8 letters at twelve months . The differences in visual acuity improvements were not statistically significant based on a two-tailed t-test ( P = 0.2 ) . Due to the presence of outliers in each group , a Mann – Whitney U test was performed to confirm the results ( U = 325 ; P = 0.28 ) . The mean optical coherence tomography foveal thickness improved 92.5 microns and 106.7 microns in the ranibizumab alone and the combined group , respectively . The difference was not significant based on a two-tailed t-test ( P = 0.6 ) . The ranibizumab alone group received an average of 6.8 injections , while the combined group received an average of three injections . This difference was not significant based on a chi-square test ( P = 0.11 ) . Conclusion The groups appeared similar based on statistical analysis , but larger studies are needed to determine possible small differences between combination therapy and monotherapy Purpose Combination verteporfin photodynamic therapy ( vPDT ) and antivascular endothelial growth factor ( anti-VEGF ) therapy may decrease the need for injections while maintaining visual acuity in exudative age-related macular degeneration . This pilot study was design ed to determine the threshold fluence dose of vPDT ( the dose required to demonstrate an effect on choroidal perfusion ) combined with ranibizumab . Methods Seven patients were r and omized to sham vPDT ( two patients ) , 20 % fluence vPDT ( two patients ) , or 40 % fluence vPDT ( three patients ) in combination with three-monthly intravitreal 0.5 mg ranibizumab injections . Intravitreal ranibizumab was reinjected if disease activity was seen on fluorescein angiography , optical coherence tomography , or clinical examination . Indocyanine green-determined choroidal hypoperfusion was grade d in a masked fashion . Results Patients with 20 % vPDT had mild hypoperfusion defects at seven days that resolved by week 4 ( threshold dose ) ; patients with 40 % fluence vPDT had marked hypoperfusion at seven days that persisted as long as 12 months . Recruitment was stopped after limited efficacy was observed . One patient with 20 % fluence vPDT lost 19 letters at one year ; no other patient lost or gained > 10 letters . Central retinal thickness decreased in six of seven patients , but ranibizumab injections did not decrease . Conclusion This pilot study shows that the threshold fluence dose of vPDT ( when combined with ranibizumab ) is approximately 20 % st and ard fluence , and that mild and transient choroidal hypoperfusion can occur . Forty percent fluence vPDT causes a more prolonged and striking hypoperfusion . Despite hypoperfusion , no decrease in visual acuity or injections required was noted , suggesting that even higher fluence levels of vPDT may be necessary to decrease the number of anti-VEGF injections 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 , place \n Output:\n " }, { "from": "agent", "value": "As major adverse events , the differences in the number of eye pain , endophthalmitis , hypertension and arterial thromboembolic events were not significant between the two groups , and the incidence of serious adverse events in the two groups was very low .\nFor the maintenance of vision , the comparison of the combination of ranibizumab with PDT vs ranibizumab monotherapy shows no apparent difference .\nCompared with the combination of ranibizumab and PDT , patients treated with ranibizumab monothearpy may gain more visual acuity ( VA ) improvement .\nThe combination treatment group had a tendency to reduce the number of ranibizumab retreatment .\nBoth the two treatment strategies were well tolerated" } ]

[ { "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 Cancer Information Service ( CIS ) of the National Cancer Institute ( NCI ) is a health communications program that disseminates information through two channels : to individuals through a toll-free telephone service and to organizations ( serving primarily underserved population s ) through an outreach program . People call the 1 - 800 - 4-CANCER line to meet a variety of information needs . The information specialists who respond to these calls are prepared to answer questions ranging from cancer prevention to early detection , treatment , and survivorship . In a 1996 r and om sample survey , 2,489 callers were asked why they called , how they valued the information , and what health-related actions they took or decisions they made since their call . Results show the CIS is highly valued by its users , with satisfaction high across gender , age , education , and racial/ethnic groups . While differences in satisfaction were observed by caller type and subject of inquiry , nearly all respondents reported that contact with the CIS increased knowledge , provided reassurance , and influenced decisionmaking and health behavior . Overall , 95 % were satisfied with CIS information , 98 % trusted the information , 92 % reported an increase in knowledge , 69 % felt reassured , and 73 % said the information helped them to better cope with their concerns . Eight out of 10 callers reported the information they received had a positive impact , with 56 % reporting taking a positive health action . Results demonstrate that health communications programs like the CIS can fill information gaps consumers must bridge to make informed health care decisions and can play an important public health role in motivating people to take actions to reduce risks and /or make decisions that lead to improved health status To test the feasibility and efficacy of a multifaceted model of shared care for men after completion of treatment for prostate cancer Background Supporting 21st century health care and the practice of evidence -based medicine ( EBM ) requires ubiquitous access to clinical information and to knowledge-based re sources to answer clinical questions . Many questions go unanswered , however , due to lack of skills in formulating questions , crafting effective search strategies , and accessing data bases to identify best levels of evidence . Methods This r and omized trial was design ed as a pilot study to measure the relevancy of search results using three different interfaces for the PubMed search system . Two of the search interfaces utilized a specific framework called PICO , which was design ed to focus clinical questions and to prompt for publication type or type of question asked . The third interface was the st and ard PubMed interface readily available on the Web . Study subjects were recruited from interns and residents on an inpatient general medicine rotation at an academic medical center in the US . Thirty-one subjects were r and omized to one of the three interfaces , given 3 clinical questions , and asked to search PubMed for a set of relevant articles that would provide an answer for each question . The success of the search results was determined by a precision score , which compared the number of relevant or gold st and ard articles retrieved in a result set to the total number of articles retrieved in that set . Results Participants using the PICO templates ( Protocol A or Protocol B ) had higher precision scores for each question than the participants who used Protocol C , the st and ard PubMed Web interface . ( Question 1 : A = 35 % , B = 28 % , C = 20 % ; Question 2 : A = 5 % , B = 6 % , C = 4 % ; Question 3 : A = 1 % , B = 0 % , C = 0 % ) 95 % confidence intervals were calculated for the precision for each question using a lower boundary of zero . However , the 95 % confidence limits were overlapping , suggesting no statistical difference between the groups . Conclusion Due to the small number of search es for each arm , this pilot study could not demonstrate a statistically significant difference between the search protocol s. However there was a trend towards higher precision that needs to be investigated in a larger study to determine if PICO can improve the relevancy of search results Background Carers provide extended and often unrecognized support to people with cancer . The aim of this study is to test the hypothesis that excessive carer burden is modifiable through a telephone outcall intervention that includes supportive care , information and referral to appropriate psycho-social services . Secondary aims include estimation of changes in psychological health and quality of life . The study will determine whether the intervention reduces unmet needs among patient dyads . A formal economic program will also be conducted . Methods / Design This study is a single-blind , multi-centre , r and omized controlled trial to determine the efficacy and cost-efficacy of a telephone outcall program among carers of newly diagnosed cancer patients . A total of 230 carer/patient dyads will be recruited into the study ; following written consent , carers will be r and omly allocated to either the outcall intervention program ( n = 115 ) or to a minimal outcall / attention control service ( n = 115 ) . Carer assessment s will occur at baseline , at one and six months post-intervention . The primary outcome is change in carer burden ; the secondary outcomes are change in carer depression , quality of life , health literacy and unmet needs . The trial patients will be assessed at baseline and one month post-intervention to determine depression levels and unmet needs . The economic analysis will include perspectives of both the health care sector and broader society and comprise a cost-consequences analysis where all outcomes will be compared to costs . Discussion This study will contribute to our underst and ing on the potential impact of a telephone outcall program on carer burden and provide new evidence on an approach for improving the wellbeing of carers . Trial registration Australian New Zeal and Clinical Trials RegistryACTRN : 12613000731796 Goal Men diagnosed with prostate cancer experience high decision-related distress concurrent with cancer-related distress . Psycho-education , problem solving and decision support were integrated in a novel telephone-delivered supportive care intervention targeting men at diagnosis and assessed for feasibility . Material s and Methods An exploratory single-group pre – post-test design tracked session frequency , duration and content . St and ardised measures assessed decisional conflict , cancer-related distress and decision involvement . Brief screening measures for psychological and decision-related distress were incorporated into the intervention protocol . Twenty men ( 77 % response ) newly diagnosed with localised prostate cancer received the intervention . Results Men who were undecided about treatment at study entry required more pre-treatment intervention calls ( p < 0.013 ) . Pre-treatment support calls were longer ( M = 40.2 min ) and more complex by comparison to post-treatment calls ( M = 30.9 min ; p < 0.002 ) . Brief screening for decision-related distress correlated with concurrent ( p < 0.008 ) and prospect i ve ( p < 0.046 ) decisional conflict . Decisional conflict and intrusion decreased at post-test ( p < 0.001 ; p < 0.005 ) . Men reported a high level of satisfaction with the support received with benefits identified including anonymity and accessibility . Conclusions In this setting , a tele-based supportive care and decision support intervention for men newly diagnosed with prostate cancer was feasible . The use of brief screening measures as within-intervention clinical tools appears promising Background Management of cancer treatment-related symptoms is an important safety issue given that symptoms can become life-threatening and often occur when patients are at home . With funding from the Canadian Partnership Against Cancer , a pan-Canadian steering committee was established with representation from eight provinces to develop symptom protocol s using a rigorous methodology ( CAN-IMPLEMENT © ) . Each protocol is based on a systematic review of the literature to identify relevant clinical practice guidelines . Protocol s were vali date d by cancer nurses from across Canada . The aim of this study is to build an effective and sustainable approach for implementing evidence -informed protocol s for nurses to use when providing remote symptom assessment , triage , and guidance in self-management for patients experiencing symptoms while undergoing cancer treatments . Methods A prospect i ve mixed- methods study design will be used . Guided by the Knowledge to Action Framework , the study will involve ( a ) establishing an advisory knowledge user team in each of three targeted setting s ; ( b ) assessing factors influencing nurses ’ use of protocol s using interviews/focus groups and a st and ardized survey instrument ; ( c ) adapting protocol s for local use , ensuring fidelity of the content ; ( d ) selecting intervention strategies to overcome known barriers and implementing the protocol s ; ( e ) conducting think-aloud usability testing ; ( f ) evaluating protocol use and outcomes by conducting an audit of 100 r and omly selected charts at each of the three setting s ; and ( g ) assessing satisfaction with remote support using symptom protocol s and change in nurses ’ barriers to use using survey instruments . The primary outcome is sustained use of the protocol s , defined as use in 75 % of the calls . Descriptive analysis will be conducted for the barriers , use of protocol s , and chart audit outcomes . Content analysis will be conducted on interviews/focus groups and usability testing with comparisons across setting s. Discussion Given the importance of patient safety , patient-centered care , and delivery of quality services , learning how to effectively implement evidence -informed symptom protocol s in oncology healthcare services is essential for ensuring safe , consistent , and effective care for individuals with cancer . This study is likely to have a significant contribution to the delivery of remote oncology services , as well as influence symptom management by patients at home OBJECTIVE There is a paucity of r and omized controlled trials ( RCTs ) to evaluate models of palliative care . Although interventions vary , all have faced a variety of method ological challenges including adequate recruitment , missing data , and contamination of the control group . We describe the ENABLE II intervention , methods , and sample baseline characteristics to increase intervention and method ological transparency , and to describe our solutions to selected method ological issues . METHODS Half of the participants recruited from our rural U.S. comprehensive cancer center and affiliated clinics were r and omly assigned to a phone-based , nurse-led educational , care coordination palliative care intervention model . Intervention services were provided to half of the participants weekly for the first month and then monthly until death , including bereavement follow-up call to the caregiver . The other half of the participants were assigned to care as usual . Symptoms , quality of life , mood , and functional status were assessed every 3 months until death . RESULTS Baseline data of 279 participants were similar to normative sample s. Solutions to method ological challenges of recruitment , missing data , and \" usual care \" control group contamination are described . SIGNIFICANCE OF RESULTS It is feasible to overcome many of the method ological challenges to conducting a rigorous palliative care RCT OBJECTIVE The purpose of this study was to investigate the accuracy of oncologists ' recognition of their patients ' supportive care needs and symptoms in breast cancer outpatient consultation in Japan . METHODS The participants included a sample of r and omly selected out patients with breast cancer and two oncologists . The patients responded to vali date d self-administered question naires to assess their supportive care needs and symptoms . The oncologists responded to a question naire in which they indicated their perception of level of the same set of needs or symptoms following consultation . The two data sets were compared statistically . RESULTS Complete data sets were available for 408 patients . Low negative predictive values for the psychological ( 30 % ) and information domain ( 30 % ) indicated that the patients often have psychological and information needs that the oncologists do not appropriately recognize . The sensitivity and specificity of the physicians ' assessment for all physical symptoms except pain were < 40 and > 85 % , respectively , indicating that the physicians could not detect , but could rule out the possibility of a patient experiencing physical symptoms . Borderline/ clinical depression and anxiety were the only two symptoms that the oncologists reported more frequently than the patients did . As a result , the specificity of the physicians ' assessment for the detection of borderline/ clinical depression and anxiety was relatively low ( 74 and 27 % ) . CONCLUSIONS Oncologists ' recognition may not accurately reflect their patients ' supportive care needs and symptoms in usual care . Incorporation of a st and ard assessment system for supportive care needs and symptoms in clinical practice must heighten the oncologists ' awareness of their patients ' these problems PURPOSE / OBJECTIVES To compare the effectiveness of two low-intensity approaches for distressed patients with cancer and caregivers who had called cancer helplines seeking support . Baseline distress was hypothesized as a moderator of intervention effect . DESIGN R and omized trial . SETTING Community-based cancer helplines in Queensl and and New South Wales , Australia . SAMPLE 354 patients with cancer and 336 caregivers . METHODS Participants were r and omized to either a single session of nurse-led self-management intervention or a five-session psychologist cognitive behavioral intervention delivered by telephone . Assessment s were undertaken at baseline ( preintervention ) and at 3 , 6 , and 12 months . MAIN RESEARCH VARIABLES Psychological and cancer-specific distress and post-traumatic growth . FINDINGS No significant moderation by baseline cancer-specific distress was noted . For low-education patients , only the psychologist intervention was associated with a significant drop in distress . For all other participants , distress decreased over time in both arms with small to large effect sizes ( Cohen 's ds = 0.05 - 0.82 ) . Post-traumatic growth increased over time for all participants ( Cohen 's ds = 0.6 - 0.64 ) . CONCLUSIONS Many distressed patients with cancer and their caregivers may benefit significantly from a single session of a nurse psychoeducation intervention that can be delivered remotely by telephone and supported by self-management material s. Research is needed to develop an algorithm that moves beyond the use of distress as the only indicator for referral to specialist psychological services . Survivors and caregivers with low education and low literacy may require more in-depth and targeted support . IMPLICATION S FOR NURSING Brief nurse psychoeducation and stress management for cancer survivors and care \n Output:\n " }, { "from": "agent", "value": "The review ed studies indicate that vali date d distress-screening tools are being used via telephone to identify distress , particularly in relation to cancer .\nScreening-driven supportive care referrals are also taking place in telephone-based services .\nHowever , not all services use an established referral protocol .\nOngoing rescreening of callers ’ distress is also limited despite it being an important recommendation from psycho-oncology guidelines" } ]

[ { "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 study was design ed to investigate the effect of tacrolimus ( FK506 ) and of cyclosporine ( CsA ) on tubular function in renal graft recipients . Patients were r and omised after renal transplantation to immunosuppressive treatment with FK506 ( n = 8) or CsA ( n = 8) . Patients had a mean age of 45.7 + /- 3.4 yr ; there was no difference in age , sex , HLA status or CMV mismatches . Neither was there any difference in the frequency of episodes of acute kidney failure between the groups , nor was there a significant difference in the frequency of episodes of kidney rejection within the first year . The mean FK506 level at the time lay at 14.7 + /- 14.4 ng/mL whole blood , and the mean CsA level at the time of study was 162 + /- 25 ng/mL whole blood . We performed renal function studies 6 months after transplantation : CIn , CPAH , NaHCO3 loading , and Na2SO4 loading . There was no significant impairment of GFR in patients treated with FK506 with 53.6 + /- 2.5 mL/min as compared to 58 + /- 6 mL in group 2 . Plasma renin activity ( 0.6 + /- 0.4 ng/mL vs 2.3 + /- 3 ; p < 0.01 ) and aldosterone ( 69 + /- 17 vs 157 + /- 28.2 pg/mL ; p < 0.05 ) were significantly decreased during treatment with FK506 . Fractional HCO3 excretion was low in both groups , indicating that bicarbonate reabsorption in the proximal nephron was unimpaired . Distal renal tubular acidosis was demonstrated in 4 patients of group 1 but in only 1 of group 2 . Potassium levels were slightly increased in patients treated with FK506 ( 5.4 + /- 0.2 mmoL/L ) as compared to cyclosporine ( 4.9 + /- 0.3 mmoL/L ; p < 0.05 ) . Distal hydrogen ion secretion , evaluated by the ability to increase urinary pCO2 in a highly alkaline urine , was impaired in patients treated with FK506 ( U-B pCO2 : 16.1 + /- 4 vs 36 + /- 5.8 ; p < 0.05 ) as compared to patients treated with CsA. The maximum acidification capability ( NAE ) was slightly lowered during therapy with FK506 ( 67.5 + /- 11.8 versus 86.6 + /- 16.5 mumoL/min , ns ) . We conclude that FK506 administration results in a decrease in the rate of hydrogen ion secretion by the collecting tubules . This defect was disclosed by the finding of a subnormal pCO2 in a highly alkaline urine . These results show that FK506 is able to induce distal tubular acidosis . Distal tubular acidosis is part of FK506 induced nephrotoxicity , the pathogenesis of this type of hyperkalemic metabolic acidosis found in patients treated with FK506 after renal transplantation has to be further eluci date BACKGROUND The economic impact of therapies has increasingly become part of the clinical decision-making process . Costs associated with kidney transplantation are substantial and economic evaluations are useful in identifying immunosuppressive regimens that yield optimal clinical and economic benefits . METHODS Utilisation of health care re sources during the first 6-months after renal transplantation was examined in 557 kidney transplant recipients participating in a European , multicentre , r and omised , parallel group study that compared the efficacy and safety of a tacrolimus-based regimen versus a cyclosporin-microemulsion-based regimen . Cost-minimisation and cost-effectiveness analyses were conducted from an Italian hospital perspective , including direct medical costs only ( e.g. medication , hospitalisation ) . RESULTS The incidence of acute rejection was significantly lower in the tacrolimus group than in the cyclosporin microemulsion ( ME ) group ( 32.5 % versus 51.3 % ; p<0.001 ) . Patient and graft survival were similar in both treatment groups . Renal transplant recipients receiving tacrolimus-based immunosuppression had lower utilisation of health care re sources and lower total costs per patient than cyclosporin-ME treated patients . When surviving patients with a rejection-free graft were analysed , tacrolimus therapy was cost-saving , since it was both more effective ( 18.8 % difference in the incidence of acute rejection ; 95%CI 10.7%-26.8 % ; p<0.001 ) and less costly than cyclosporin-ME based therapy ( cost difference euro9918 ) . The costs per patient with a functioning graft were euro2305 , the costs per surviving patient were euro1892 lower in tacrolimus treated patients . Sensitivity analyses using the key cost-drivers ( hospitalisation , study drug , and concomitant medication ) found the cost advantage of tacrolimus was maintained . CONCLUSION In the first 6 months after renal transplantation , tacrolimus-based therapy was less costly than cyclosporin-ME based therapy . When surviving patients with a rejection-free graft were considered , tacrolimus was the dominant therapy Lipoprotein patterns in renal transplant patients : a comparison between FK 506 and cyclosporine A patients The development of diabetes mellitus in the renal transplant population was first reported by Starzl in 1964 and was attributed to the use of steroids.1 Since then , posttransplant diabetes mellitus has been associated with the use of other immunosuppressive agents , such as cyclosporine ( CyA ) . Because FK 506 is also thought to be diabetogenic,2 We retrospectively looked at the incidence of new onset diabetes mellitus in patients treated primarily with either FK 506 or CyA in a r and omized trial of kidney transplantations done at the University of Pittsburgh from February 1990 to May 1991 BACKGROUND In previous comparative studies tacrolimus was superior to the st and ard formulation of ciclosporin in preventing acute rejection after renal transplantation . We have compared the microemulsion formulation of ciclosporin with tacrolimus in a multicentre r and omised trial . METHODS The 6-month open study involved 560 patients in 50 European centres . 287 patients were r and omly assigned tacrolimus and 273 ciclosporin microemulsion plus azathioprine and corticosteroids . The initial oral daily doses were 0.30 mg/kg for tacrolimus and 8 - 10 mg/kg for ciclosporin . The primary endpoint was the proportion of patients with biopsy-proven acute rejection and the time to this event . FINDINGS The two study groups were similar in terms of baseline characteristics . Three patients did not receive study treatment or did not undergo transplantation ( one tacrolimus , two ciclosporin ) . The rate of biopsy-confirmed acute rejection was significantly lower with tacrolimus than with ciclosporin microemulsion ( 56 patients [ 19.6 % ] vs 101 [ 37.3 % ] ; 17.7 % difference [ 95 % CI 10.3 - 25.1 ] ; p<0.0001 ) . Biopsy-confirmed corticosteroid-resistant rejection was also significantly lower with tacrolimus ( 27 [ 9.4 % ] vs 57 [ 21.0 % ] ; 11.6 % difference [ 5.7 - 17.5 ] ; p<0.0001 ) . Cross-over between therapies because of biopsy-proven rejection was judged necessary in one of 286 ( 0.3 % ) tacrolimus-group patients and 27 of 271 ( 10.0 % ) ciclosporin-group patients ( p<0.0001 ) . There were no significant differences in survival of patients or grafts or in renal function . The overall frequency of adverse events was similar in the two groups , though hypertension and hypercholesterolaemia were more common in the ciclosporin group and tremor and hypomagnesaemia were more frequent in the tacrolimus group . INTERPRETATION Tacrolimus was significantly more effective than ciclosporin microemulsion in preventing acute rejection after renal transplantation and had a superior cardiovascular-risk profile FK 506 was compared with cyclosporin in a r and omised trial in good-risk cadaveric renal transplant recipients . The objective was to evaluate whether oral FK 506 dosing was viable and whether blood concentrations in the range 10 - 20 ng/ml would prove to be practical . Thirty-one adult patients were r and omised to FK 506 and 16 to cyclosporin . Both groups received an identical regimen of azathioprine and corticosteroids . Serum creatinine concentrations decreased rapidly in both groups with mean values below 200 mumol/l within 2 weeks . One graft in the cyclosporin group was lost due to renal vein thrombosis . During the 6-week study period , 19.4 % of patients on FK 506 and 31.3 % on cyclosporin experienced acute rejection . One patient in each group experienced corticosteroid-resistant rejection that responded to anti-lymphocyte therapy . Infections were reported in 51.6 % of the FK 506 group compared with 37.5 % of the cyclosporin group . The spectrum of adverse events was similar in both groups . However , minor neurological disorders were more common in the FK 506 group ( 54.8 % versus 6.3 % ) whereas hypertension was less common ( 48.8 % versus 75.0 % ) . The results indicate that oral FK 506 rapidly achieves therapeutic blood concentrations and is an effective immunosuppressant for the initial treatment of renal allograft recipients CONTEXT Tacrolimus , microemulsion cyclosporine ( Neoral ) , and mycophenolate mofetil ( MMF ) at 2 and 3 grams daily have demonstrated superior immunosuppressive properties in several recent clinical trials involving solid-organ transplants . An effective immunosuppression may be maintained with lower doses of MMF administered with either tacrolimus or microemulsion cyclosporine . OBJECTIVE To compare tacrolimus plus \" low-dose \" MMF-based immunosuppressive regimen ( TMBIR ) with Neoral plus \" low-dose \" MMF-based immunosuppressive regimens ( NMBIR ) among kidney transplant recipients . DESIGN Prospect i ve , r and omized study . PATIENTS 53 consecutive adult recipients of kidney transplant . Both groups ( TMBIR and NMBIR ) were equally matched on demographic characteristics . INTERVENTIONS Participants were r and omized to receive orally either tacrolimus ( 0.08 mg/kg twice daily ) ( n = 27 ) or Neoral ( 4 mg/kg twice daily ) ( n = 26 ) . Both regimens were started before surgery and continued when allograft demonstrated no postoperative acute tubular necrosis . Both groups received similar \" low-dose \" MMF ( 500 mg twice daily ) and prednisone ( 2 mg/kg/day to taper off after 1 year ) . Switch from tacrolimus to Neoral or vice versa was allowed after refractory rejection or serious adverse events . MAIN OUTCOME MEASURE Acute rejection and patient and graft survival 1 year following kidney transplant . RESULTS One-year patient survival rates were 88.9 % for the TMBIR group and 100 % for the NMBIR group ; 1-year graft survival rates were 88.9 % for the TMBIR group and 96.1 % for the NMBIR group . No significant differences were found in the incidence of biopsy-confirmed acute rejection ( 14.8 % TMBIR vs 23 % NMBIR ) . Steroid-resistant rejections requiring cytolytic antibody therapy were higher in the NMBIR group ( 50 % vs 25 % ) . Three patients crossed over from NMBIR to TMBIR for refractory rejections and 1 patient crossed over from TMBIR to NMBIR for new onset seizure . Three episodes of cytomegalovirus infection were observed in the TMBIR group . Other adverse events were similar in both groups . CONCLUSIONS Both tacrolimus and microemulsion cyclosporine combined with \" low-dose \" MMF and corticosteroids provide effective immunosuppression and have similar adverse events in kidney transplant recipients BACKGROUND Our clinical trial was design ed to investigate the optimal combination of immunosuppressants for renal transplantation . METHODS A r and omized three-arm , parallel group , open label , prospect i ve study was performed at 15 North American centers to compare three immunosuppressive regimens : tacrolimus + azathioprine ( AZA ) versus cyclosporine ( Neoral ) + mycophenolate mofetil ( MMF ) versus tacrolimus + MMF . All patients were first cadaveric kidney transplants receiving the same maintenance corticosteroid regimen . Only patients with delayed graft function ( 32 % ) received antilymphocyte induction . A total of 223 patients were r and omized , transplanted , and followed for \n Output:\n " }, { "from": "agent", "value": "We demonstrated no differences in infection or malignancy .\nAUTHORS ' CONCLUSIONS Tacrolimus is superior to cyclosporin in improving graft survival and preventing acute rejection after kidney transplantation , but increases post-transplant diabetes , neurological and gastrointestinal side effects ." } ]

[ { "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 The pathophysiology of sepsis-associated delirium is not completely understood and the data on cerebral perfusion in sepsis are conflicting . We tested the hypothesis that cerebral perfusion and selected serum markers of inflammation and delirium differ in septic patients with and without sepsis-associated delirium . Methods We investigated 23 adult patients with sepsis , severe sepsis , or septic shock with an extracranial focus of infection and no history of intracranial pathology . Patients were investigated after stabilisation within 48 hours after admission to the intensive care unit . Sepsis-associated delirium was diagnosed using the confusion assessment method for the intensive care unit . Mean arterial pressure ( MAP ) , blood flow velocity ( FV ) in the middle cerebral artery using transcranial Doppler , and cerebral tissue oxygenation using near-infrared spectroscopy were monitored for 1 hour . An index of cerebrovascular autoregulation was calculated from MAP and FV data . C-reactive protein ( CRP ) , interleukin-6 ( IL-6 ) , S-100β , and cortisol were measured during each data acquisition . Results Data from 16 patients , of whom 12 had sepsis-associated delirium , were analysed . There were no significant correlations or associations between MAP , cerebral blood FV , or tissue oxygenation and sepsis-associated delirium . However , we found a significant association between sepsis-associated delirium and disturbed autoregulation ( P = 0.015 ) . IL-6 did not differ between patients with and without sepsis-associated delirium , but we found a significant association between elevated CRP ( P = 0.008 ) , S-100β ( P = 0.029 ) , and cortisol ( P = 0.011 ) and sepsis-associated delirium . Elevated CRP was significantly correlated with disturbed autoregulation ( Spearman rho = 0.62 , P = 0.010 ) . Conclusion In this small group of patients , cerebral perfusion assessed with transcranial Doppler and near-infrared spectroscopy did not differ between patients with and without sepsis-associated delirium . However , the state of autoregulation differed between the two groups . This may be due to inflammation impeding cerebrovascular endothelial function . Further investigations defining the role of S-100β and cortisol in the diagnosis of sepsis-associated delirium are warranted . Trial registration Clinical Trials.gov NCT00410111 Abstract . Objective : Perfusion abnormalities are an overall phenomenon in severe sepsis and septic shock , leading to organ dysfunction . We investigated whether carbon dioxide (CO2)-induced vasomotor reactivity ( VMR ) is impaired in septic patients , compared with values obtained outside sepsis . Design : Prospect i ve , clinical study . Setting : Six-bed neurologic critical care unit of a university hospital . Patients and participants : Eight consecutive patients with severe sepsis and septic shock . Measurements and results : CO2-reactivity was measured during and outside a period of severe sepsis or septic shock according to ACCP/SCCM criteria by means of transcranial Doppler sonography and near-infrared spectroscopy ( NIRS ) . VMR was calculated as the percentage change of cerebral blood flow velocity ( normalized CO2-reactivity , NCR ) and absolute changes in concentration of oxygenated hemoglobin , deoxygenated hemoglobin , total hemoglobin ( HbO2 , Hb , HbT ) and Hbdiff ( difference between HbO2 and Hb ) in µmol/l per 1 % increase in end-tidal CO2 ( CR-HbO2 , CR-Hb , CR-HbT , CR-Hbdiff ) . NCR and NIRS-reactivities were significantly reduced during severe sepsis and septic shock compared with values outside sepsis ( mean , SD , Wilcoxon ) : NCR 11.0 ( 7.1 ) versus 30.7 ( 13.0 ) , p<0.02 ; CR-HbO2 0.70 ( 0.61 ) versus 2.33 ( 1.11 ) , p<0.02 ; CR-Hb –0.17 ( 0.74 ) versus –1.42 ( 1.28 ) , p<0.04 ; CR-HbT 0.53 ( 0.48 ) versus 1.05 ( 0.40 ) , p<0.03 ; CR-Hbdiff 0.91 ( 1.33 ) versus 3.75 ( 2.33 ) , p<0.02 . This indicates a severely disturbed VMR . Conclusions : In the advent of a disturbed cerebral autoregulation , critical drops in blood pressure during sepsis are transferred directly into the vascular bed , leading to cerebral hypoperfusion . This mechanism might contribute to the pathogenesis of septic encephalopathy Introduction Pathophysiology of brain dysfunction due to sepsis remains poorly understood . Cerebral microcirculatory alterations may play a role ; however , experimental data are scarce . This study sought to investigate whether the cerebral microcirculation is altered in a clinical ly relevant animal model of septic shock . Methods Fifteen anesthetized , invasively monitored , and mechanically ventilated female sheep were allocated to a sham procedure ( n = 5 ) or sepsis ( n = 10 ) , in which peritonitis was induced by intra-abdominal injection of autologous faeces . Animals were observed until spontaneous death or for a maximum of 20 hours . In addition to global hemodynamic assessment , the microcirculation of the cerebral cortex was evaluated using Sidestream Dark-Field ( SDF ) videomicroscopy at baseline , 6 hours , 12 hours and at shock onset . At least five images of 20 seconds each from separate areas were recorded at each time point and stored under a r and om number to be analyzed , using a semi-quantitative method , by an investigator blinded to time and condition . Results All septic animals developed a hyperdynamic state associated with organ dysfunction and , ultimately , septic shock . In the septic animals , there was a progressive decrease in cerebral total perfused vessel density ( from 5.9 ± 0.9 at baseline to 4.8 ± 0.7 n/mm at shock onset , P = 0.009 ) , functional capillary density ( from 2.8 ± 0.4 to 2.1 ± 0.7 n/mm , P = 0.049 ) , the proportion of small perfused vessels ( from 95 ± 3 to 85 ± 8 % , P = 0.02 ) , and the total number of perfused capillaries ( from 22.7 ± 2.7 to 17.5 ± 5.2 n/mm , P = 0.04 ) . There were no significant changes in microcirculatory flow index over time . In sham animals , the cerebral microcirculation was unaltered during the study period . Conclusions In this model of peritonitis , the cerebral microcirculation was impaired during sepsis , with a significant reduction in perfused small vessels at the onset of septic shock . These alterations may play a role in the pathogenesis of septic encephalopathy Introduction The pathophysiology of sepsis-associated encephalopathy ( SAE ) is not entirely clear . One of the possible underlying mechanisms is the alteration of the cerebral microvascular function induced by the systemic inflammation . The aim of the present work was to test whether cerebral vasomotor-reactivity is impaired in patients with SAE . Methods Patients fulfilling the criteria of clinical sepsis and showing disturbance of consciousness of any severity were included ( n = 14 ) . Non-septic persons whithout previous diseases affecting cerebral vasoreactivity served as controls ( n = 20 ) . Transcranial Doppler blood flow velocities were measured at rest and at 5 , 10 , 15 and 20 minutes after intravenous administration of 15 mg/kgBW acetazolamide . The time course of the acetazolamide effect on cerebral blood flow velocity ( cerebrovascular reactivity , CVR ) and the maximal vasodilatory effect of acetazolemide ( cerebrovascular reserve capacity , CRC ) were compared among the groups . Results Absolute blood flow velocities after adminsitration of the vasodilator drug were higher among control subjects than in SAE . Assessment of the time-course of the vasomotor reaction showed that patients with SAE reacted slower to the vasodilatory stimulus than control persons . When assessing the maximal vasodilatory ability of the cerebral arterioles to acetazolamide during vasomotor testing , we found that patients with SAE reacted to a lesser extent to the drug than did control subjects ( CRC controls:46.2 ± 15.9 % , CRC SAE : 31,5 ± 15.8 % , P < 0.01 ) . Conclusions We conclude that cerebrovascular reactivity is impaired in patients with SAE . The clinical significance of this pathophysiological finding has to be assessed in further studies OBJECTIVE To determine whether the severity of septic encephalopathy is correlated with gram-negative bacteremia and mortality and whether there exists a single or combination of metabolic derangements(s ) that cause septic encephalopathy . DESIGN AND SETTING Prospect i ve case series in an academic medical center . PATIENTS Fifty patients selected according to clinical and laboratory criteria for severe sepsis . The criteria included temperature , heart rate , respiratory rate , and hypotension and /or signs of systemic hypoperfusion . MAIN OUTCOME MEASURES A single or combination of metabolic and laboratory derangements and organ failures , three different methods to grade the severity of septic encephalopathy , Acute Physiology and Chronic Health Evaluation II ( APACHE II ) scores , gram-negative bacteremia and infection , and mortality . RESULTS Encephalopathy was associated with an increase in mortality when grade d by the Glasgow Coma Score ; a score of 15 had 16 % mortality , 13 to 14 had 20 % , 9 to 12 had 50 % , and 3 to 8 had 63 % mortality ( P < .05 ) . Bacteremia was associated with encephalopathy ; 13 % of septic patients without encephalopathy vs 59 % of patients with encephalopathy had bacteremia ( P < .001 ) when grade d by altered mental status . Septic encephalopathic patients had elevated serum urea nitrogen and bilirubin levels , increased APACHE II scores , and a higher incidence of renal failure . CONCLUSIONS The severity of septic encephalopathy correlated with mortality , bacteremia , and renal and hepatic dysfunction . The Glasgow Coma Score is a useful tool for characterizing septic encephalopathy . Considerable variations can be found according to different criteria used to classify septic encephalopathy Objective To study the correlation between a dynamic index of cerebral autoregulation assessed with blood flow velocity ( FV ) using transcranial Doppler , and a tissue oxygenation index ( TOI ) recorded with near-infrared spectroscopy ( NIRS ) . Methods Twenty-three patients with sepsis , severe sepsis , or septic shock were monitored daily on up to four consecutive days . FV , TOI , and mean arterial blood pressure ( ABP ) were recorded for 60 min every day . An index of autoregulation ( Mx ) was calculated as the moving correlation coefficient between 10-s averaged values of FV and ABP over moving 5 min time-windows . The index Tox was evaluated as the correlation coefficient between TOI and ABP in the same way . The indices Mx and Tox , ABP and arterial partial pressure of CO2 were averaged for each patient . Results Synchronized slow waves , presenting with periods from 20 s to 2 min , were seen in the TOI and FV of most patients , with a reasonable coherence between the signals in this b and width ( coherence > 0.5 ) . The indices , Mx and Tox , demonstrated good correlation with each other ( R = 0.81 ; P < 0.0001 ) in the whole group of patients . Both indices showed a significant ( P < 0.05 ) tendency to indicate weaker autoregulation in the state of vasodilatation associated with greater values of arterial partial pressure of CO2 or lower values of ABP . Conclusion NIRS shows promise for the continuous assessment of cerebral autoregulation in adults INTRODUCTION The pathophysiology of sepsis-associated encephalopathy ( SAE ) is not entirely clear , but one of the possible underlying mechanisms is the alteration of the cerebral microvascular function . The aim of the present work was to test whether cerebral vasomotor reactivity is impaired in patients with severe sepsis . METHODS Patients fulfilling the criteria of clinical sepsis and showing at least 2 organ dysfunctions were included ( n = 16 ) . Nonseptic healthy persons without previous diseases affecting cerebral vasoreactivity served as controls ( n = 16 ) . Transcranial Doppler blood flow velocities were measured at rest and at 5 , 10 , 15 , and 20 minutes after intravenous administration of 15 mg/kg acetazolamide . The time course of the acetazolamide effect on cerebral blood flow velocity ( cerebrovascular reactivity [ CVR ] ) and the \n Output:\n " }, { "from": "agent", "value": "A temporal pattern of the evolution of the illness was found .\nIn early sepsis , the median blood flow velocity ( Vm ) and pulsatility index ( PI ) increased , and the cerebral autoregulation ( CA ) remained unchanged .\nIn contrast , Vm normalization , PI reduction and CA impairment were found in later sepsis ( patients with severe sepsis or septic shock ) .\nCerebral haemodynamic is impaired in sepsis .\nModifications in cerebral blood flow may be consequence to the endothelial dysfunction of the microvasculature induced by the release of inflammatory mediators .\nA better underst and ing of cerebral hemodynamics may improve the clinical management of patients with sepsis and , consequently , improve 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 : Dysmenorrhea is a common gynecologic disorder affecting as many as 60 % of menstruating women . In the United States , work absenteeism due to dysmenorrhea is estimated to be 600 million work hours per year , and the economic consequences are estimated at $ 2 billion per year ; therefore , it is a public problem nowadays . Aim : The purpose of this study was to compare the effects of combination of fennel extract/vitamin E with ibuprofen on the intensity of pain in primary dysmenorrhea among the students of Tabriz city in 2007 - 2009 . Material s and Methods : This study was done by using double-blinded quasi-experimental research method . After taking the required licenses from ethics committee , 68 students from Medical and Tabriz universities , who were living in the dormitory , suffering from primary dysmenorrhea , and were eligible for the study , were r and omly divided into two groups of 34 students each ( the two groups used combination of fennel extract/vitamin E and ibuprofen cross-over form in the 2 months ) . We used Visual Analogue Scale ( VAS ) tool for ranking the intensity of the pain . Data analysis was done by using SPSS Ver . 14 . Results : The mean of peak pain intensity in the first , second , third , sixth , and forty-eighth hours in the group that had used combination of fennel extract/vitamin E was lower than the group that had used ibuprofen , and statistical differences were observed between the two groups in the first and second hours ; combination of fennel extract/vitamin E was more effective than ibuprofen in the first hour ( P < 0.03 ) and second hour ( P < 0.04 ) . Conclusion : Combination of fennel extract/vitamin E is effective on decreasing the intensity of pain of primary dysmenorrhea , and it is advised to those who can not use chemical drugs Background Zingiber officinale R. rhizome ( ginger ) is a popular spice that has traditionally been used to combat the effects of various inflammatory diseases . The aim of this study was to evaluate the effects of ginger on pain relief in primary dysmenorrhea . Method This was a r and omized , controlled trial . The study was based on a sample of one hundred and twenty students with moderate or severe primary dysmenorrhea . The students were all residents of the dormitories of Shahed University . They were r and omly assigned into two equal groups , one for ginger and the other for placebo in two different treatment protocol s with monthly intervals . The ginger and placebo groups in both protocol s received 500 mg capsules of ginger root powder or placebo three times a day . In the first protocol ginger and placebo were given two days before the onset of the menstrual period and continued through the first three days of the menstrual period . In the second protocol ginger and placebo were given only for the first three days of the menstrual period . Severity of pain was determined by a verbal multidimensional scoring system and a visual analogue scale . Results There was no difference in the baseline characteristics of the two groups ( placebo n = 46 , ginger n = 56 ) . The results of this study showed that there were significant differences in the severity of pain between ginger and placebo groups for protocol one ( P = 0.015 ) and protocol two ( P = 0.029 ) . There was also significant difference in duration of pain between the two groups for protocol one ( P = 0.017 ) but not for protocol two ( P = 0.210 ) . Conclusion Treatment of primary dysmenorrhea in students with ginger for 5 days had a statistically significant effect on relieving intensity and duration of pain . Trial registration I RCT OBJECTIVE To evaluate the impact of valerian-a herb with sedative effects and antispasmodic effects on smooth muscles-on the severity of dysmenorrhea . METHODS In a double-blind , r and omized , placebo-controlled trial , 100 students were r and omly assigned to receive valerian ( n=49 ) or placebo ( n=51 ) . Valerian ( dose 255 mg ) was given 3 times daily for 3 days beginning at the onset of menstruation , for 2 consecutive menstrual cycles . At baseline and during the intervention cycles , the pain severity was evaluated with a visual analog scale and the systemic manifestations were assessed using a multidimensional verbal scale . RESULTS The pain severity at baseline did not differ significantly between the groups . After the intervention , the pain severity was significantly reduced in both groups ( P<0.001 ) , but the extent of the reduction was larger in the valerian group , with the difference between the 2 groups being statistically significant ( P<0.05 ) . The total scores of the systemic manifestations associated with dysmenorrhea decreased after the intervention , but there was no significant difference between the groups , with the exception for syncope ( P<0.05 ) . CONCLUSION Valerian seems to be an effective treatment for dysmenorrhea , probably because of its antispasmodic effects Background : Dysmenorrhea has negative effects on women 's life . Due to side-effects of chemical drugs , there is growing trend toward herbal medicine . The aim of this study was to assess the effect of Dill compared to mefenamic acid on primary dysmenorrhea . Material s and Methods : This double-blind , r and omized , clinical trial study was conducted on 75 single female students between 18 and 28 years old educating in Nursing and Midwifery School and Paramedical Faculty of Qom University of Medical Sciences of Iran in 2011 . They were allocated r and omly into one of the three groups : In Dill group , they took 1000 mg of Dill powder q12h for 5 days from 2 days before the beginning of menstruation for two cycles . Other groups received 250 mg mefenamic acid or 500 mg starch capsule as placebo , respectively . Dysmenorrhea severity was determined by a verbal multidimensional scoring system and a visual analog scale ( VAS ) . Students with mild dysmenorrhea were excluded . Data were analyzed by SPSS using the descriptive statistic , paired- sample s t-test , Wilcoxon signed-rank test , Mann-Whitney test , and Kruskal-Wallis test . Results : There were no significant differences between three groups for demographic or descriptive variables . Comprising the VAS showed that the participants of Dill and mefenamic acid groups had lower significant pain in the 1st and the 2nd months after treatment , whereas in the placebo group this was only significant in the 2nd month ( P < 0.05 ) . Conclusion : Dill was as effective as mefenamic acid in reducing the pain severity in primary dysmenorrhea . Further studies regarding side-effects of Dill and its interactivity are recommended OBJECTIVE Wujijing Oral Liquid ( WJJ ) contained principally the flesh essence of the black-boned chicken . As a kind of food and medicine in China , it was used to treat the menstrual disturbance traditionally , but the exact mechanism of the action was not yet clear . The clinical effects of the WJJ on the symptoms of the menstrual disturbance and the reproductive hormones were studied in this paper . MATERIAL S AND METHODS The 53 women with the menstrual disturbance were selected as the study object , and then they were r and omly divided to receive either WJJ 10mL twice daily ( n=28 ) or the placebo ( n=25 ) from the 1st day after menstrual flow for 2 menstrual cycles . On the 1st day after the discontinuation of the medication but before the treatment , the scores for the menstrual pattern and the related symptoms were obtained and the blood sample s were collected to test the reproductive hormones . The serum levels of the follicle-stimulating hormone ( FSH ) , luteinizing hormone ( LH ) , prolactin ( PRL ) and estradiol ( E2 ) were examined by enzyme-linked immunosorbent assay ( ELISA ) . The levels of progesterone ( P ) and testosterone ( T ) in serum were measured by the radioimmunoassay . RESULTS The score for the primary and related symptoms of the menstruation was increased significantly among patients treated with the WJJ . The differences on the FSH , PRL , and E2 levels of patients were significant before and after the treatment with WJJ . Comparing the WJJ group and the placebo group , the levels of P and T differed significantly after treatment . The oral liquid of WJJ was found to be safe , as it did not cause any change in the hepatic and renal functional parameters . CONCLUSION The oral liquid of Wujijing could improve the menstrual disturbance and were generally safe and well tolerated . The possible mechanism could be associated with its effects in reinforcing the kidney and regulating the hypothalamus-pituitary-ovary axis ( HPOA ) Our objective was to examine the effect of an Iranian herbal drug in the treatment of primary dysmenorrhea . A r and omized , double-blind , placebo-controlled pilot trial among 180 female students at Isfahan University dormitory aged 18 to 27 who suffered from primary dysmenorrhea was undertaken . The participants were r and omly divided into three groups : herbal drug , mefenamic acid , and placebo . The herbal drug group was given 500 mg of highly purified saffron , celery seed , and anise ( SCA ) extracts three times a day for three days , starting from the onset of bleeding or pain . Participants were followed for two to three cycles from the beginning of menstruation through the three days of bleeding . Main outcome measures were the severity and duration of pain at 2 and 3 months . A visual analogue scale was used to record pain . There were statistically significant reductions in pain scores and pain duration scores in the groups that took SCA ( P < . 001 ) and mefenamic acid ( P < . 01 ) . The decrease in pain score was reflected by a significant reduction in other drug use among the treatment groups compared with the women in the placebo group . The magnitude of the reduction was significantly greater in the SCA group than in the mefenamic acid and placebo groups . Both drugs effectively relieved menstrual pain as compared with the placebo . More clinical trials are needed to establish the efficacy of this herbal drug Objective Preliminary evaluation of efficacy and safety of uzara use in treatment of moderate and severe primary dysmenorrhea in comparison to ibuprofen . Material s and Methods This r and omized , comparative two way cross-over study comprised 60 single female students at Faculty of Medicine , Ain Shams University , Egypt , aged 19–28 years with moderate ( n = 46 ) or severe ( n = 14 ) primary dysmenorrhea . Participants were r and omized to take either uzara ( 80 mg/8 hours for two doses , then 40 mg/8 hours ) then ibuprofen ( 400 mg/6 hours ) in two subsequent cycles or vice versa . The pain intensity , using VAS , was recorded immediately before taking the medication ( 0 hour ) and after 4 , 12 , 24 , 48–60 , 96–120 hours . Main outcome measures included effectiveness of pain relief defined as drop of VAS to 3 or less , patient 's global evaluation of the drug , absence from school , the use of a rescue medication , and , in those who continued the treatment , the pain intensity difference ( PID ) at different points after start of medication and its sum ( SPID ) . Results Uzara was comparably effective to ibuprofen ( 78.3 % vs. 86.7 % of cycles ; respectively ) , with comparable rates of effectiveness on global evaluation ( being around 50 % for either drug ) , and rates of school absences ( 11.7 % vs. 13.3 % ; respectively ) . The need for rescue medication was different ( 18.3 % and 10 % ; respectively ) , albeit with no statistical significance . The means of PID at different time points and SPID were comparable , with significantly lower average mean of VAS scores compared to that felt with no medication ( 1.6 vs. 6.8 , p<0.001 ) . Side effects were less with uzara than ibuprofen ( 0 % vs. 8.3 % , p<0.05 ) . Conclusions Uzara might be as effective as ibuprofen in management of primary dysmenorrhea but with less side effects . These findings need to be confirmed by a properly design ed trial with a larger sample size . Trial Registration Current Controlled Trials IS RCT Background : Primary dysmenorrhea refers to the occurrence of painful menstrual cramps of uterus and is considered as a gynecological complaint . The common treatment for this problem is medical therapy such as mefenamic acid [ non-steroidal anti-inflammatory drugs ( NSAIDs ) ] and oral contraceptive pills , both of which work by reducing myometrial activity . Fennel contains an antispasmodic and anethol agents and may be helpful for management of primary dysmenorrhea . Material and Methods : The aim of this study was to evaluate the effects of oral fennel drop for treating primary dysmenorrhea . Sixty college students suffering from primary dysmenorrhea were r and omly assigned to two groups and followed up for two cycles . Statistical analysis was performed using SPSS version 16 . P < 0.05 was considered to be statistically significant . Parametric and non-parametric tests were adopted . Results : Comparison of pain intensity in the two groups showed that there was no significant difference in pain relief between the two groups . Comparison of bleeding severity in the study group before and after intervention was demonstrated from the first day to the fifth day ( PV on first day , second day , third day , fourth day , and fifth day 0.948 , 0.330 , 0.508 , 0.583 , 0.890 , respectively ) . Conclusion : It seems that fennel can be effective in reducing the severity of dysmenorrhea , but it \n Output:\n " }, { "from": "agent", "value": "Effectiveness of supplements for secondary dysmenorrhoea There was no strong evidence of benefit for melatonin compared to placebo for dysmenorrhoea secondary to endometriosis ( data were unsuitable for analysis ) .\nThere was no evidence of a difference between the groups but data were too scanty to reach any conclusions about safety .\nThere is no high quality evidence to support the effectiveness of any dietary supplement for dysmenorrhoea , and evidence of safety is lacking ." } ]

[ { "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 emergence and spread of bacterial resistance to antibiotics is a growing problem worldwide , which presents a significant threat to public health globally in the 21st century . A substantial evidence has shown that the general community plays a role in the increase and spread of antibiotic resistance . The present study was design ed to determine knowledge , attitude and practice towards antibiotic use . Methods A cross-sectional survey was performed using a pretested self-administered question naire on a sample of 770 r and omly selected Kuwaiti individuals . Descriptive and multivariate logistic regression analysis were used in data analysis . Results The response rate was 88.3 % . Nearly three-quarters ( 72.8 % ) of respondents had been prescribed antibiotics within 12 months prior to the study period , and 36 % of them had not finished the course of treatment . Over one-quarter ( 27.5 % ) were self-medicated with antibiotics to treat mainly common cold , sore throat and cough . Self-medication was more prevalent among those who were prescribed antibiotics and those who had attitudes towards using and accessing antibiotic inappropriately . Almost 47 % of participants had low knowledge regarding action , use , safety and resistance of antibiotics . Forty one percent of respondents had attitudes towards using and accessing antibiotic inappropriately . Better knowledge was found to be a predictor for positive attitude . Respondents level of agreement that doctors often prescribe antibiotics to meet the patient ’s expectation , and that doctors often take time to consider carefully the need for an antibiotic were 52.7 % and 35.3 % , respectively . Conclusions These findings will aid in the assessment of the adequacy of present public educational campaigns . Also , it will provide further insight in design ing future multifaceted interventions to promote specific messages to rationalize antibiotic use , and compensate for knowledge and attitude gaps as an effort towards preventing development of antibiotic resistance Background . Antibiotics are responsible for most dramatic improvement in medical therapy in history . These medications contributed significantly to the decreasing mortality and morbidity when prescribed based on evidence of microbial infection . Objective . The aim of this study was to determine the prevalence and predictors of self-prescription with antibiotics in Al Wazarat Health Center , Riyadh City , Kingdom of Saudi Arabia . Material and Methods . Cross-sectional study was conducted in Al Wazarat Health Center between February 2014 and November 2014 . Respondents were r and omly selected using a multistage clustered r and om sampling technique . Data was entered into SPSS version 21 and analyzed . Descriptive statistics and multiple logistic regression models were applied . Results . A total of 681 patients have participated in this study with a response rate of 92 % . The prevalence of self-prescription with antibiotics in Al Wazarat Health Center was 78.7 % . Amoxicillin was the most used self-prescribed antibiotic with prevalence of ( 22.3 % ) . Friend advice on self-prescription of antibiotics use ( p = 0.000 ) and pharmacy near to the participants ( p = 0.002 ) were the most common predictors for self-prescription with antibiotics . Conclusion . The level of self-prescribing antibiotics is relatively high among participants . Health education on the appropriate use of antibiotics is highly recommended . The proper use of treatment guidelines for antibiotic therapy will significantly reduce self-prescription with antibiotics Since the dawn of therapeutics , the prescribing of medications and their use by patients has been marked by substantial variability in both rationality and effectiveness . Drug use historically has reflected the highest principles of science as well as strikingly irrational behavior . This heterogeneity has been particularly vivid in the case of antibiotics . Antibiotics are among the most commonly used therapeutic agents , accounting for 12 % of ambulatory care prescriptions ( 1 ) . Their use ranges from treatment of minor self-limited outpatient symptoms to potentially fatal conditions in critically ill patients . Antibiotics loom large economically as well , accounting for approximately 15 % of the nearly $ 100 billion in annual medication expenditures in the United States ( 2 ) . Because of their role in treating infections , antibiotics tap into some of our most deeply held beliefs about bodily integrity and invasion . Furthermore , other than certain vaccines , antibiotics are the only drug class whose use influences not just the patient being treated but the entire ecosystem in which he or she lives , with potentially profound consequences . The determinants of antibiotic use and misuse are thus of particular importance . They include factors as diverse as the physicianpatient relationship , clinical microbiology , health economics , and the most basic definitions of illness and therapy ( 3 ) . Factors Leading to Antibiotic Misuse In their psychosocial dimension , medications can have properties that transcend pharmacology and may take center stage in some clinical situations . Social scientists and wise clinicians have long been aware that providing a patient with a drug is an interpersonal as well as a biochemical intervention ( 4 ) ; this is particularly true of antibiotics . The writing of a prescription signifies that the physician has made a diagnosis and that treatment is possible . A prescription officially ( and tangibly ) assigns the patient to the sick role , with all of its benefits and responsibilities ( 5 ) . It can also act as a termination strategy for an office visit , a sign that the visit has been consummated , the encounter is complete , and it is time for the patient to move on . This strategy creates a paradoxical outcome in the current environment , which is so preoccupied with throughput . A prescription for an antibiotic is often seen as the quickest way to end the visit of a patient with possible infectious symptoms . The number of patients seen per hour is increasing , and such increased productivity is frequently commended in the same management memor and um that criticizes out-of-control drug expenditures . Ironically , managers ' desire to reduce the use of diagnostic tests ( cultures ) and prevent return visits also creates pressures that favor heavy antibiotic use . Through the alchemy of the pharmacy , the paper prescription and its inscrutable ritualistic writings are transformed into a container of tablets or capsules . In a real sense , the drug prescription prolongs the physicianpatient encounter by enabling the patient to ingest a dose of the doctor several times a day . As Sir William Osler noted , The desire to ingest medicines is one of the principal features which distinguish man from the animals ( 6 ) . This perspective helps to explain the drug hunger that many symptomatic patients bring to the physician visit , in which they feel satisfied only by receiving a prescription ( 7 ) . Such dem and s are not based on clinical data as we know it ( 8 - 10 ) . Patient expectations have been further intensified by the advent of direct-to-consumer advertising of antibiotics by pharmaceutical manufacturers . Unlike the situation of depression , incontinence , or impotence , for which undertreatment is common , no logic exists for increasing the public 's dem and for antibiotics . These advertisements serve primarily to persuade patients to dem and newer , more costly antibiotics in clinical situations in which older , generic products , or no drug at all , would often work just as well . They are skillfully constructed to promote the ease or effectiveness of the target product and , of course , do not mention cost or note the similar effects of older therapies ( 11 ) . Two trends have intensified the effect of direct-to-consumer promotion of antibiotics . First , the credibility of many once-respected sources of authority is waning , taking a toll on physicians ' professional sovereignty ( 12 , 13 ) . Related to this trend is the parallel rise of consumer activism ; worried that their health maintenance organization will deny them needed therapy to reduce expenditures , patients dem and treatments that they fear might otherwise be withheld . Taken together , these trends turn therapeutic decision making into more of a dialogue ( at best ) or a tug-of-war ( at worst ) between patient and physician , a phenomenon that would have been unthinkable a generation ago . Add to this a growing if belated concern over patient satisfaction , the drive to shorten outpatient encounters as much as possible , and aggressive marketing directed at physicians , and the stage is set for the dem and and receipt of astoundingly large quantities of unnecessary antibiotics . Viewed in this context , it is not surprising that the small voice of therapeutic restraint and concern about microbial resistance is so difficult to hear above the din . The movement favoring adoption of clinical guidelines for rational antibiotic use often runs headlong into the pressures on the primary care physician as the proprietor of a small business , just trying to get through the day and satisfy his or her customers . For example , in focus groups design ed to reveal physicians ' knowledge about , attitudes toward , and motivations for prescribing , some clinicians presented with clinical vignettes that were constructed to sound compellingly viral in cause still favored use of antibiotics to improve symptoms and reduce the likelihood of superinfection ( 14 ) . However , a larger group argued that even if antibiotics were not indicated , they often felt obliged to prescribe them because of patient dem and . This problem is still more acute in the developing world , although a full discussion is beyond the scope of this paper . In the inpatient setting , a different set of forces conspires to encourage excessive antibiotic use . In teaching hospitals , prescribing decisions frequently are made by those with the least clinical experience ( interns and residents ) ; at the same time , each year hospitalized patients become more acutely ill and their cases increasingly complex . These factors , combined with the ubiquitous pressure to keep length of stays short ( the inpatient equivalent of the shrinking office visit ) , make it difficult to pursue a course of watchful waiting in managing a fever of unknown origin . Such temperance is particularly difficult if the prescribing physician has been in practice for only a few months . The first priority becomes the prevention of disaster within the next 24 hours , a goal often thought to be met best by broad-spectrum antibiotics or a cacophony of narrower-spectrum agents used in combination . Evidence for Antibiotic Misuse The perspective outlined above helps explain why analyses of antibiotic use patterns have consistently documented that prescribing is suboptimal ( 15 ) . Many r and omized , placebo-controlled trials of acute bronchitis , cough , and upper respiratory illnesses have found that outcomes are no better in typical patients taking antibiotics than in those given placebo ( 8 - 10 ) . However , of the 51 million visits for colds , upper respiratory tract infections , and bronchitis in the United States in one recent year , 50 % to 66 % culminated in an antibiotic prescription ( 16 , 17 ) . Clinical factors often seem to play a minor role in antibiotic decision making in these illnesses . Diagnostic uncertainty also plays a role ; a recent study of patients with sore throats found that two thirds of antibiotic prescriptions were written for patients whose cultures came back negative ( 18 ) . A large current survey of antibiotic use in treating infectious symptoms in children revealed widespread disregard of commonly recommended diagnostic strategies and therapeutic guidelines and frequent overuse of antibiotics in upper respiratory tract infections ( 65 % ) ( 19 ) . Several patient demographic factors have been found to increase the likelihood that antibiotics will be prescribed . These include being female , young , and white and living in a rural area ( 15 ) . In the developing world , social and economic factors as well as suboptimal drug use have driven the emergence and spread of multidrug-resistant tuberculosis ( 20 ) . In hospitalized patients , incorrect dosing or poor choice of drug occurs often . In a study performed at one teaching hospital ( 21 ) , we found that physicians usually ordered inappropriate doses or intervals for clindamycin , metronidazole , and cefazolin . At another large hospital , antibiotic prophylaxis before surgery was found to be correctly timed in only 40 % of cases ( 22 ) . At the same institution , physicians did not respond correctly to 25 % of instances in which culture and sensitivity data were available ( 23 ) . Overuse of such antibiotics as vancomycin raises concern about the emergence of resistant organisms as well as cost . One recent study found that only 40 % of orders at several hospitals were compatible with Centers for Disease Control and Prevention ( CDC ) guidelines ( 24 ) . Overuse of vancomycin is probably an important factor in the spread of resistance ( 25 ) ; during a period when vancomycin use was rapidly increasing , resistance rates increased from 0.8 % to 4.0 % ( 26 ) . Antibiotic Resistance and Costs The total costs associated with antibiotics come from multiple sources : medication , adverse events , and the often hidden cost of antimicrobial resistance ( 2 ) . Adverse events occur in a small proportion of antibiotic courses , but because of the frequency of antibiotic use , they accounted for 23 % of all adverse events recorded at one INTRODUCTION Antimicrobial resistance is a serious global health concern . It has considerable implication s on societies ' health and re sources . In Jordan , there is a large Iraqi community due to the ongoing turmoil in Iraq . Unfortunately , health awareness and practice s of this community are under-investigated due to scarcity of research . This paper assesses the awareness of antibiotic use and antimicrobial resistance in the Iraqi community residing in Amman , Jordan . Their level of interaction with health care professionals regarding antibiotics and differences in their antibiotic use between Iraq and Jordan are also discussed . METHODOLOGY A cross-sectional question naire-based survey involving r and omly selected Iraqis residing in Amman , Jordan was conducted . RESULTS The study involved 508 participants . Sixty-two percent of participants agreed with buying antibiotics without a prescription , 29 % agreed with obtain \n Output:\n " }, { "from": "agent", "value": "Age , sex , and educational and income levels were the main determinants of SMA .\nSocio-cultural , economic , and regulatory factors were the most commonly cited reasons for SMA .\nPenicillins were the antibiotics most commonly used ; the antibiotics were obtained mainly via stored leftover drugs , pharmacies without prescriptions , and friends/relatives .\nSMA was mainly for upper respiratory tract problems ." } ]

[ { "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 prospect ively study S-100B and neuron specific enolase ( NSE ) levels in subjects treated for severe head injury ( sTBI ) , and investigate the prognostic value of these biomarkers . Methods : Subjects included in a prospect i ve double blind r and omised study for sTBI . Inclusion criteria : Glasgow Coma Score ( GCS ) ⩽8 , age 15–70 years , first recorded cerebral perfusion pressure of > 10 mm Hg and arrival < 24 h after trauma . Subjects were treated with an intracranial pressure ( ICP ) targeted therapy . Blood sample s for S-100B and NSE were drawn immediately after arrival and every 12 h for 5 days . Outcome was evaluated as Glasgow Outcome Scale ( GOS ) by independent staff at 3 and 12 months . Results : 48 subjects , mean age 35.5 years , and median GCS 6 were included . The first blood sample was drawn at 15.6 ( 1.4 ) h after injury . Initial concentration of S-100B was 1.04 ( 0.21 ) μg/l and for NSE 18.94 ( 2.32 ) μg/l . The biomarkers were significantly higher in subjects with GCS 3 and in those who died compared with those with GCS 4–8 and GOS 2–5 , respectively . Receiver operated characteristic curve analyses of the initial S-100B and NSE levels to GOS dichotomised as unfavourable ( GOS 1–3 ) and favourable ( GOS 4–5 ) showed a weak correlation : AUC 0.585 and 0.555 , respectively . Using the dichotomisation dead ( GOS 1)/alive ( GOS 2–5 ) , the AUC values were 0.687 and 0.734 , respectively . Furthermore , a correlation was found between the biomarkers themselves and the biomarkers and ICP . Conclusion : At 3 and 12 months after trauma , no differences in prognostic values between the markers were apparent nor was there any clinical significant value of the markers as predictors of clinical outcome Purpose To identify factors associated with decisions to withdraw life-sustaining therapies in patients with severe traumatic brain injury ( TBI ) . Material s and Methods We conducted a 2-year multicenter retrospective cohort study ( 2005–2006 ) in mechanically ventilated patients aged 16 years and older admitted to the intensive care units ( ICUs ) of six Canadian level I trauma centers following severe TBI . One hundred and twenty charts were r and omly selected at each center ( n = 720 ) . Data on ICU management strategies , patients ’ clinical condition , surgical procedures , diagnostic imaging , and decision to withdraw life-sustaining therapies were collected . The association of factors pertaining to the injury , interventions , and management strategies with decisions to withdraw life-sustaining therapies was evaluated among non-survivors . Results Among the 228 non-survivors , 160 died following withdrawal of life-sustaining therapies . Patients were predominantly male ( 69.7 % ) with a mean age of 50.7 ( ±21.7 ) years old . Brain herniation was more often reported in patients who died following decisions to withdraw life-sustaining therapies ( odds ratio [ OR ] 2.91 , 95 % confidence interval [ CI ] 1.16–7.30 , p = 0.02 ) compared to those who died due to other causes ( e.g. , cardiac arrest , shock , etc . ) . Epidural hematomas ( OR 0.18 , 95 % CI 0.06–0.56 , p < 0.01 ) , craniotomies ( OR 0.12 , 95 % CI 0.02–0.68 , p = 0.02 ) , and other non-neurosurgical procedures ( OR 0.08 , 95 % CI 0.02–0.43 , p < 0.01 ) were less often associated with death following withdrawal of life-sustaining therapies than death from other causes . Conclusions Death following decisions to withdraw life-sustaining therapies is associated with specific patient and clinical factors , and the intensity of care Background : Severe traumatic brain injury often leads to death from withdrawal of life-sustaining therapy , although prognosis is difficult to determine . Methods : To evaluate variation in mortality following the withdrawal of life-sustaining therapy and hospital mortality in patients with critical illness and severe traumatic brain injury , we conducted a two-year multicentre retrospective cohort study in six Canadian level-one trauma centres . The effect of centre on hospital mortality and withdrawal of life-sustaining therapy was evaluated using multivariable logistic regression adjusted for baseline patient-level covariates ( sex , age , pupillary reactivity and score on the Glasgow coma scale ) . Results : We r and omly selected 720 patients with traumatic brain injury for our study . The overall hospital mortality among these patients was 228/720 ( 31.7 % , 95 % confidence interval [ CI ] 28.4%–35.2 % ) and ranged from 10.8 % to 44.2 % across centres ( χ2 test for overall difference , p < 0.001 ) . Most deaths ( 70.2 % [ 160/228 ] , 95 % CI 63.9%–75.7 % ) were associated with withdrawal of life-sustaining therapy , ranging from 45.0 % ( 18/40 ) to 86.8 % ( 46/53 ) ( χ2 test for overall difference , p < 0.001 ) across centres . Adjusted odd ratios ( ORs ) for the effect of centre on hospital mortality ranged from 0.61 to 1.55 ( p < 0.001 ) . The incidence of withdrawal of life-sustaining therapy varied by centre , with ORs ranging from 0.42 to 2.40 ( p = 0.001 ) . About one half of deaths that occurred following the withdrawal of life-sustaining therapies happened within the first three days of care . Interpretation : We observed significant variation in mortality across centres . This may be explained in part by regional variations in physician , family or community approaches to the withdrawal of life-sustaining therapy . Considering the high proportion of early deaths associated with the withdrawal of life-sustaining therapy and the limited accuracy of current prognostic indicators , caution should be used regarding early withdrawal of life-sustaining therapy following severe traumatic brain injury Elevated serum neuron-specific enolase levels are correlated with brain cell damage . Low scores according to Glasgow Coma Scale are also considered as serious poor prognostic factor . The aims of the study were to investigate whether there is a correlation between the two measurements in patients with traumatic brain injury and whether serum neuron-specific enolase levels have potential as a screening test to predict outcome . A total of 169 consecutive patients with traumatic brain injury admitted to our clinic between 2002 and 2005 are included in this study . Those patients , who had any major health problem before trauma , were excluded from the study . However , patients with isolated head injury were included in the study . Serial serum neuron-specific enolase concentrations taken at the first 2 , 24 , and 48 h after traumatic brain injury were analyzed . A computed tomography was performed on each patient on admission . Their Glasgow Coma Scale scores were recorded serially . The relationship between Glasgow Coma Scale scores and the serum neuron-specific enolase levels were assessed by statistical methods . There was a significant negative correlation between the serum neuron-specific enolase levels and Glasgow Coma Scale scores . The levels of neuron-specific enolase were significantly higher in the patients who died in 30 days after trauma and whose scores were lower than or equal to 8 points in Glasgow Coma Scale . Although there are several serious limitations of the use of neuron-specific enolase as a biomarker in traumatic brain injury ( i.e. , hypoperfusion , extracranial trauma , bleeding , liver , or kidney damage also increase the level of neuron-specific enolase ) , its concentrations may be useful as a practical and helpful screening test to identify neurotrauma patients who are at increased risk and may provide supplementary estimation with radiological and clinical findings In recent years , in addition to neurological examination and neuroradiologic examinations , attempts have been made to assess the severity of post-traumatic brain injury and to obtain an early idea of patient prognosis using biochemical markers with a high degree of brain tissue specificity . One such enzyme is neuron-specific enolase ( NSE ) . This study investigates the correlation between serum NSE levels , Glasgow Coma Score , and prognosis measured by Glasgow Outcome Scores in head trauma patients . This was a prospect i ve study conducted with 80 trauma patients presenting to the Emergency Department . Patients were divided into four groups . The first group consisted of patients with general body trauma , but no head trauma . The second group had minor head trauma . The third group had moderate head trauma , and the fourth group had severe head trauma . The relationship between subjects ' admission NSE levels and admission and discharge Glasgow Coma Scores ( GCS ) and Glasgow Outcome Scores ( GOS ) 1 month later was examined . A receiver operating characteristic ( ROC ) analysis was performed using a serum NSE cutoff level of 20.52 ng/mL and a GOS of 3 or less as the definition of poor neurologic outcome . There was a significant difference in the NSE levels between group 1 ( general trauma ) and group 3 ( moderate head trauma ) . There was also a statistically significant difference in NSE levels between group 1 ( general trauma ) and group 4 ( severe head trauma ) ( p < 0.05 ) . There was a statistically significant inverse relationship between NSE levels and GOS as determined within groups 3 ( moderate ) and 4 ( severe head trauma ) ( p < 0.05 ) . When NSE levels were compared with admission GCS , it was found that GCS fell as NSE levels rose . There was no significant correlation between NSE and GCS within groups 3 ( moderate ) or 4 ( severe ) . There was a statistically significant correlation within group 2 ( mild ) ( p < 0.05 ) . By ROC analysis , serum NSE was 87 % sensitive and 82.1 % specific in predicting poor neurologic outcome in the study patients . The area under the curve was 0.931 . This study shows that initial serum NSE levels in moderate and severe head trauma patients correlate inversely with GOS 1 month later , but only within the moderate and severe head trauma groups . However , serum NSE was 87 % sensitive and 82.1 % specific in predicting poor neurologic outcome in all of the study patients . This derived cutoff value now needs to be prospect ively vali date OBJECTIVE The aim of this study was to investigate S-100B protein and NSE as a serum marker of brain cell damage after traumatic brain injury . MATERIAL AND METHODS Forty-one patients with traumatic brain injury were included in this prospect i ve study . Venous blood sample s for S-100B protein and NSE were taken after admission and on the next day . Serum levels of S-100 protein and NSE were compared with Glasgow Coma Scale score , computed tomographic findings and outcome after 3 months . RESULTS Serum S-100B protein and NSE were significantly correlated with Glasgow Coma Scale score and outcome after 3 months . The significant correlation was found between the initial S-100B and NSE ( P < 0.001 ) . In patients without parenchymal injuries on computed tomographic scan such as epidural hematoma and concussion , the elevation of S-100B protein and NSE was observed . The initial values of S-100B and NSE in acute subdural hematomas with unfavorable outcome were significantly higher than in those with favorable outcome . Secondary increase of serum markers was associated with the presence of secondary insult such as hypoxia or hypotension , and was found to have an unfavorable outcome . CONCLUSIONS Serum concentration and kinetics of S-100B protein and NSE provide the clinical assessment of the primary brain damage and have a predictive value for outcome after traumatic brain injury Summary We investigated the time course of neuron specific enolase ( NSE ) and S-100 protein after severe head injury in correlation to outcome . We included 30 patients ( GCS<9 ) , who had been admitted within 5 hours after injury , in a prospect i ve study . Blood sample s were taken on admission , 6 , 12 . and 24 hours and every 24 hours up to the fifth day after injury . The outcome was estimated on discharge using the Glasgow Outcome Scale . 70 % reached a good outcome . All concentrations of NSE and 83 % of the S-100 sample s were elevated concerning the first probe ( 30.2 μg/l NSE mean and 2.6 μg/l S-100 mean ) . Patients with bad outcome had an NSE concentration of 38 μg/l ( mean ) compared with 26.9 μg/l ( mean ) in patients with good outcome . Patients with bad outcome had an S-100 concentration of 4.9 μg/l ( mean ) compared with 1.7 μg/l ( mean ) in patients with good outcome ( p<0.05 ) . The mean values of NSE and S-100 decreased during the first 5 days . Four patients with increasing intracranial pressure showed a quick increasing concentration of NSE , in two patients the S-100 level showed a slower rise . The NSE serum levels did not correlate with intracranial pressure values . Our results show that the first serum concentration of S-100 seems to be predictive for outcome after severe head injury Neuron-specific en \n Output:\n " }, { "from": "agent", "value": "INTERPRETATION In patients with moderate or severe traumatic brain injury , increased neuron-specific enolase serum levels are associated with unfavourable 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 —Arterial distensibility measures , generally from pulse-wave velocity ( PWV ) , are widely used with little knowledge of relationships to patient outcome . We tested whether aortic PWV predicts cardiovascular and all-cause mortality in type 2 diabetes and glucose-tolerance – tested ( GTT ) multiethnic population sample s. Methods and Results — Participants were r and omly sample d from ( 1 ) a type 2 diabetes outpatient clinic and ( 2 ) primary care population registers , from which nondiabetic control subjects were given a GTT . Brachial blood pressures and Doppler-derived aortic PWV were measured . Mortality data over 10 years ’ follow-up were obtained . At any level of systolic blood pressure ( SBP ) , aortic PWV was greater in subjects with diabetes than in controls . Mortality risk doubled in subjects with diabetes ( hazard ratio 2.34 , 95 % CI 1.5 to 3.74 ) and in those with glucose intolerance ( 2.12 , 95 % CI 1.11 to 4.0 ) compared with controls . For all groups combined , age , sex , and SBP predicted mortality ; the addition of PWV independently predicted all-cause and cardiovascular mortality ( hazard ratio 1.08 , 95 % CI 1.03 to 1.14 for each 1 m/s increase ) but displaced SBP . Glucose tolerance status and smoking were other independent contributors , with African-Caribbeans experiencing reduced mortality risk ( hazard ratio 0.41 , 95 % CI 0.25 to 0.69 ) . Conclusions —Aortic PWV is a powerful independent predictor of mortality in both diabetes and GTT population sample s. In displacing SBP as a prognostic factor , aortic PWV is probably further along the causal pathway for arterial disease and may represent a useful integrated index of vascular status and hence cardiovascular risk AIMS Increased arterial wave reflections are associated with the presence and extent of coronary atherosclerosis and with cardiovascular mortality in selected population s. We prospect ively evaluated their prognostic value in the short- and long-term following percutaneous coronary interventions ( PCIs ) . METHODS AND RESULTS We non-invasively quantified wave reflections [ expressed as augmentation index corrected for heart rate of 75 b.p.m . ( AIx@75 ) ] using applanation tonometry of the radial artery and a vali date d transfer function to obtain the corresponding aortic values in 262 patients undergoing PCI . During 2-year follow-up , 61 patients reached the primary endpoint [ death , myocardial infa rct ion ( MI ) , and restenosis ] . Increasing tertiles of Alx@75 were related to the rate of patients reaching the primary endpoint [ 15.2 , 20 and 35.3 % , respectively ( P = 0.001 ) ] , as well as the secondary endpoints total mortality , myocardial infa rct ion and death plus myocardial infa rct ion ( RR for the third vs. the first tertile 4.33 , 3.25 and 3.46 , respectively , P < 0.05 ) . In a multivariable Cox-regression model , AIx@75 added prognostic value above and beyond clinical risk factors , angiographic variables , and medications ( RR 1.8 , 95%CI 1.18 - 2.76 per increasing AIx@75-tertile , P < 0.01 ) . CONCLUSION Increased arterial wave reflections are independently associated with an increased risk for severe short- and long-term cardiovascular events in patients undergoing PCI Isolated systolic hypertension is an important risk factor for cardiovascular disease and results primarily from elastic artery stiffening . Although various drug therapies are used to lower peripheral blood pressure ( BP ) in patients with isolated systolic hypertension , the effects of the 4 major classes of antihypertensive agents on central BP , pulse pressure ( PP ) amplification , and arterial stiffness in this condition are not clear . Fifty-nine patients over the age of 60 years with untreated isolated systolic hypertension ( systolic BP ≥140 mm Hg and diastolic BP ≤90 mm Hg ) were r and omly assigned to receive 1 of the following 4 antihypertensive agents : perindopril , atenolol , lercanidipine , or bendrofluazide . BP was measured using a mercury sphygmomanometer , and augmentation index and carotid-femoral ( aortic ) pulse wave velocity were measured at baseline , after 2 weeks of placebo therapy , and at the end of 10 weeks of active therapy . Peripheral systolic BP and peripheral PP were reduced similarly after treatment with all 4 classes of drug . However , central PP was only reduced significantly by perindopril , lercanidipine , and bendrofluazide , whereas atenolol had no effect . Lercanidipine reduced the augmentation index , whereas atenolol increased it . Aortic pulse wave velocity was not changed by any of the drugs . In summary , despite similar reductions in peripheral systolic and PPs with the 4 classes of drug , changes in central pressure and augmentation index varied . Because central PP and increased wave reflections are considered important risk factors in patients with isolated systolic hypertension , the choice of therapy may be influenced by these findings in the future We compared the effect of losartan ( 50 mg/day ) to hydrochlorthiazide ( 12.5 mg/day ) on blood pressure ( BP ) and arterial stiffness in 11 untreated hypertensive patients aged 47 to 69 years in a 4-week single blind r and omized crossover study with an intervening 4-week washout period . Both drugs produced a significant ( P < .001 ) and similar decrease in brachial BP . Only losartan induced a significant decrease in arterial wave reflection ( P < .0001 ) , with a preferential reduction in aortic ( P < .001 ) compared to brachial pulse pressure . Losartan also significantly increased pulse pressure amplification and reduced pulse wave velocity . These results suggest that an AT(1 ) receptor antagonist induces a BP independent decrease in aortic stiffness and arterial wave reflection Recent studies have suggested a differential influence of mean pressure and pulse pressure on myocardial infa rct ion and stroke , and differences among the major drugs in their efficacy at preventing these individual endpoints . We hypothesized that antihypertensive drugs have differing influences upon the pulse wave even when their effects on blood pressure are the same . We studied 30 untreated hypertensive patients , aged 28 - 55 years , who were rotated through six 6-week periods of daily treatment with amlodipine 5 mg , doxazosin 4 mg , lisinopril 10 mg , bisoprolol 5 mg , bendrofluazide 2.5 mg or placebo . The best drug was repeated at the end of the rotation . Blood pressure readings and radial pulse tonometry ( by Sphygmocor ) were performed at each visit , and blood was taken for measurement of levels of atrial natriuretic peptide and brain natriuretic peptide ( BNP ) . The Sphygmocor derivation of the central aortic pulse wave was used to measure time for transmission of the reflected wave ( T(R ) ) and the augmentation index ( AI ) , which is the proportional increase in systolic pressure due to the reflected wave . There was a dissociation between the effects of the drugs on blood pressure and pulse wave analysis . Bisoprolol caused the greatest falls in blood pressure and T(R ) , but was the only drug to increase AI . This paradoxical response to bisoprolol was associated with a 3-fold increase in plasma BNP levels . There was a smaller elevation of BNP in women compared with men , as described previously , and this elevation also was associated with significantly higher values of AI . Other drugs reduced AI , and this was associated with a significant decrease in BNP by amlodipine . In conclusion , antihypertensive drugs differ in their short-term effects on augmentation of the systolic pulse wave and secretion of BNP from the heart , regarded as a sensitive measure of strain on cardiomyocytes . These differences may help to explain cause-specific differences in outcome in recent trials BACKGROUND The objective of this study was to examine the association of Joint National Committee ( JNC-V ) blood pressure and National Cholesterol Education Program ( NCEP ) cholesterol categories with coronary heart disease ( CHD ) risk , to incorporate them into coronary prediction algorithms , and to compare the discrimination properties of this approach with other noncategorical prediction functions . METHODS AND RESULTS This work was design ed as a prospect i ve , single-center study in the setting of a community-based cohort . The patients were 2489 men and 2856 women 30 to 74 years old at baseline with 12 years of follow-up . During the 12 years of follow-up , a total of 383 men and 227 women developed CHD , which was significantly associated with categories of blood pressure , total cholesterol , LDL cholesterol , and HDL cholesterol ( all P<.001 ) . Sex-specific prediction equations were formulated to predict CHD risk according to age , diabetes , smoking , JNC-V blood pressure categories , and NCEP total cholesterol and LDL cholesterol categories . The accuracy of this categorical approach was found to be comparable to CHD prediction when the continuous variables themselves were used . After adjustment for other factors , approximately 28 % of CHD events in men and 29 % in women were attributable to blood pressure levels that exceeded high normal ( > or = 130/85 ) . The corresponding multivariable-adjusted attributable risk percent associated with elevated total cholesterol ( > or = 200 mg/dL ) was 27 % in men and 34 % in women . CONCLUSIONS Recommended guidelines of blood pressure , total cholesterol , and LDL cholesterol effectively predict CHD risk in a middle-aged white population sample . A simple coronary disease prediction algorithm was developed using categorical variables , which allows physicians to predict multivariate CHD risk in patients without overt CHD Background Antihypertensive agents can reduce arterial stiffness . We hypothesized that an angiotensin receptor blocker ( ARB ) irbesartan and an angiotensin converting enzyme inhibitor ( ACEI ) lisinopril improved arterial compliance . Methods A r and omized , double-blind , double-dummy , controlled crossover trial . Fifteen hypertensive patients , mean age 65.5 ± 8.9 years ( mean ± SD ) were given irbesartan ( 150 to 300 mg/day ) or lisinopril ( 10 to 20 mg/day ) for 12 weeks and then crossed over for 12 weeks . Pulse wave velocity ( PWV ) in the carotid-femoral ( CF ) , carotid-radial ( CR ) , and femoral dorsalis-pedis ( FD ) were measured using a Complior ® PWV system . Results After 12 weeks , systolic blood pressure ( SBP ) decreased from 162.4 ± 12.9 to 134.5 ± 14.8 with irbesartan and to 145.2 ± 25 mmHg with lisinopril . Irbesartan and lisinopril reduced PWV ( CF ) in the elastic arterial system from 15.1 ± 5 to 13.3 ± 2.6 ( p < 0.005 ) and to 14 ± 4.7 ( p < 0.05 ) m/s respectively ( p = 0.345 ) . Irbesartan reduced PWV ( CR ) and PWV ( FD ) , whereas lisinopril did not . The difference between treatments was significant after SBP adjustment ( p = 0.037 for PWV ( CR ) and p < 0.001 for PWV ( FD ) ) . Conclusions Irbesartan improved arterial compliance in elastic and muscular arteries , whereas lisinopril improved it only in elastic arteries Background — Few population studies addressed the prognostic significance of aortic pulse wave velocity ( APWV ) above and beyond other cardiovascular risk factors . Methods and Results — We studied a sex- and age-stratified r and om sample of 1678 Danes aged 40 to 70 years . We used Cox regression to investigate the prognostic value of APWV , office pulse pressure ( PP ) , and 24-hour ambulatory PP while adjusting for mean arterial pressure ( MAP ) and other covariates . Over a median follow-up of 9.4 years , the incidence of fatal and nonfatal cardiovascular end points , cardiovascular mortality , and fatal and nonfatal coronary heart disease amounted to 154 , 62 , and 101 cases , respectively . We adjusted for sex , age , body mass index , MAP measured in the office ( conventional PP and APWV ) or by ambulatory monitoring ( 24-hour PP ) , smoking , and alcohol intake . With these adjustments , APWV maintained its prognostic significance in relation to each end point ( P<0.05 ) , whereas office and 24-hour PP lost their predictive value ( P>0.19 ) , except for office PP in relation to coronary heart disease ( P=0.02 ) . For each 1-SD increment in \n Output:\n " }, { "from": "agent", "value": "Our data suggested that ARBs had a similar effect as other anti-hypertensive agents in reducing ba-PWV and cf-PWV .\nUpon systematic review , the renin-angiotensin-axis system mechanism seems more significant than the direct vessel dilatation system in anti-arterial stiffness mechanism ." } ]

[ { "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 Critically ill patients are predisposed to venous thromboembolism . We hypothesized that higher doses of enoxaparin would improve thromboprophylaxis without increasing the risk of bleeding . Peak anti-factor Xa ( anti-Xa ) levels of 0.1 to 0.4 IU/ml reflect adequate thromboprophylaxis for general ward patients . Studies conducted in orthopaedic patients demonstrated a statistically significant relationship between anti-Xa levels and wound haematoma and thrombosis . Corresponding levels for critically ill patients may well be higher , but have never been vali date d in large studies . Methods Eighty critically ill patients weighing 50 to 90 kilograms were r and omised in a double-blinded study to receive subcutaneous ( sc ) enoxaparin : 40 mg once daily ( QD ) , 30 mg twice daily ( BID ) , 40 mg BID , or 1 mg/kg QD , each administered for three days . Anti-Xa activity was measured at baseline , and daily at 4 , 12 , 16 and 24 hours post administration . Antithrombin , fibrinogen , and platelets were measured at baseline and twice daily thereafter . Results Two patients were transferred prior to participation . On day 1 , doses of 40 mg QD ( n = 20 ) and 40 mg BID ( n = 19 ) yielded mean peak anti-Xa of 0.20 IU/ml and 0.17 IU/ml respectively . A dose of 30 mg BID ( n = 20 ) result ed in much lower levels ( 0.08 IU/ml ) . Patients receiving 1 mg/kg QD ( n = 19 ) achieved near steady-state mean peak anti-Xa levels from day 1 ( 0.34 IU/ml ) . At steady state ( day 3 ) , mean peak anti-Xa levels of 0.13 IU/ml and 0.15 IU/ml were achieved with doses of 40 mg QD and 30 mg BID respectively . This increased significantly to 0.33 IU/ml and 0.40 IU/ml for doses of 40 mg BID and 1 mg/kg QD respectively . Thus anti-Xa response profiles differed significantly over the three days between enoxaparin treatment groups ( P < 0.0001 ) . Doses of 40 mg BID and 1 mg/kg QD enoxaparin yielded target anti-Xa levels for over 80 % of the study period . There were no adverse effects . Conclusions Doses of 40 mg QD enoxaparin ( Europe ) or 30 mg BID ( North America ) yield levels of anti-Xa which may be inadequate for critically ill patients . A weight-based dose yielded the best anti-Xa levels without bioaccumulation , and allowed the establishment of near steady-state levels from the first day of enoxaparin administration . Trial registration Current Controlled Trials IS RCT N91570009 BACKGROUND Use of low-molecular-weight heparins is avoided in patients with renal insufficiency because of concerns about an excessive anticoagulant effect and increased bleeding risk . To challenge this premise , we evaluated if deep vein thrombosis ( DVT ) prophylaxis with dalteparin sodium confers an excessive anticoagulant effect in critically ill patients with severe renal insufficiency . METHODS We conducted a multicenter , single-arm clinical trial of DVT prophylaxis with dalteparin sodium , 5000 IU once daily in critically ill patients with a creatinine clearance lower than 30 mL/min ( to convert to milliliters per second , multiply by 0.0167 ) . Bioaccumulation was defined by a trough anti-Xa level higher than 0.40 IU/mL , measured twice weekly . The pharmacodynamic properties of dalteparin were assessed by serial anti-Xa levels measured on days 3 , 10 , and 17 . RESULTS We enrolled 156 patients with a mean ( SD ) creatinine clearance of 18.9 ( 6.5 ) mL/min ; 18 were excluded because they died or were discharged before testing ( n = 3 ) or had prevalent DVT ( n = 15 ) . Of 138 patients included , the median ( interquartile range [ IQR ] ) duration of dalteparin exposure was 7 ( 4 - 12 ) days . In 120 patients who had at least 1 trough anti-Xa level ( 427 total measurements ) , no patient had bioaccumulation ( 0 % ; 95 % confidence interval [ CI ] : 0%-3.0 % ) ; the median ( IQR ) trough anti-Xa level was undetectable ( < 0.10 IU/mL [ < 0.10 to < 0.10 IU/mL ] ) . Based on serial measurements , peak anti-Xa levels were 0.29 to 0.34 IU/mL and trough levels were lower than 0.06 IU/mL. Deep vein thrombosis occurred in 7 of 138 patients ( 5.1 % ; 95 % CI , 2.5%-10.1 % ) ; major bleeding occurred in 10 patients ( 7.2 % ; 95 % CI , 4.0%-12.8 % ) , all with trough anti-Xa levels of 0.18 IU/mL or lower . CONCLUSION In critically ill patients with severe renal insufficiency , DVT prophylaxis with dalteparin sodium , 5000 IU once daily , is not associated with an excessive anticoagulant effect due to drug bioaccumulation and is unlikely to contribute to bleeding . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00138099 WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT Venous thromboembolism is a frequent complication in critically ill patients that has a negative impact on patient outcomes . Critically ill patients have significantly lower plasma anti-factor-Xa activity levels compared with control patients after administration of subcutaneous heparin . The clinical relevance of the different anti-factor-Xa levels after prophylactic doses of low molecular weight heparin ( LMWH ) in critically ill patients is not completely understood . WHAT THIS STUDY ADDS The st and ard dose of 40 mg enoxaparin led to a significant increase in anti-FXa levels in this selected cohort of ICU patients with normal renal function . This study found only subtle pharmacokinetic differences , but a comparable pharmacodynamic action , after enoxaparin administration in critically ill and normal medical ward patients . Thrombin generation with TGA RC-low and TGARC-high reagents was significantly reduced in ICU and normal ward patients after receiving LMWH . Both readouts appear equally useful for estimating the pharmacodynamics of enoxaparin . The ex vivo model of thrombosis was used for the first time in patients to evaluate the anti-thrombotic activity of LMWH . This method did not show any difference in thrombus formation after administration of enoxaparin in the individual group of patients . AIM In critically ill patients , reduced anti-FXa plasma activity following subcutaneous administration of enoxaparin or nadroparin has been described . In this study , we aim ed to investigate the bioactivity of enoxaparin in critically ill patients and controls . METHODS A prospect i ve , controlled , open label study was performed on a medical intensive care unit ( ICU ) and a general medical ward . Fifteen ICU patients ( male = 12 , median age 52 years [ IQR 40 - 65 ] , with a median Simplified Acute Physiology Score of 30 [ IQR 18 - 52 ] ) and sex- and age-matched medical ward patients were included . The anti-FXa plasma activity was measured after a single subcutaneous dose of40 mg enoxaparin . The thrombus size of a clot formed in an ex vivo perfusion chamber and endogenous thrombin potential ( ETP ) were measured . RESULTS The anti-FXa plasma activity increased significantly after enoxaparin administration , with peak levels at 3 h after treatment , but was comparable between the ICU and medical ward groups ( median 0.16 IU ml-1 [ IQR 0 - 0.22 IU ml-1 ] vs. 0.2 IU ml-1 [ IQR 0.15 - 0.27 IU ml-1],respectively , P = 0.13 ) . The area under the anti-FXa activity curve from 0–12 h was similar between the groups ( median 0.97 IU ml-1 h [ IQR0.59 - 2.1 ] and 1.48 IU ml-1 h1 [ IQR 0.83 - 1.62 ] , P = 0.42 for the ICU group compared with the control group , respectively ) . The ETP was lower in the ICU group ( P < 0.05 ) at baseline , but it was comparable at 3 h between the groups . Thrombus size decreased at 3 h compared with pre-dose ( P = 0.029 ) and was not different between the groups . CONCLUSION Similar bioactivity was achieved with a st and ard dose of subcutaneous enoxaparin in this selected cohort of ICU and general ward patients with normal renal function Introduction Intensive care unit ( ICU ) patients often suffer from subcutaneous oedema , due to administration of large fluid volumes and the underlying pathophysiological condition . It is unknown whether the presence of subcutaneous oedema impairs the absorption of dalteparin , a low molecular weight heparin , when it is given by subcutaneous administration for venous thromboembolism prophylaxis . The objective of this study is to compare the anti-Xa activity of dalteparin after subcutaneous administration in ICU patients with and without subcutaneous oedema . Methods This non-r and omized open parallel group follow-up pilot study was conducted in two mixed medical-surgical intensive care units at two teaching hospitals . Seven ICU patients with subcutaneous oedema ( index group ) and seven ICU patients without subcutaneous oedema ( reference group ) were studied . Anti-Xa activity was determined at 0 , 3 , 4 , 6 , 8 , 12 and 24 hours after subcutaneous administration of 2,500 IU dalteparin . Plasma concentrations of factor anti-Xa activity were measured using a chromogenic factor Xa inhibition assay . Results The characteristics of the index group were : age , 58 years ; male/female ratio , 5/2 ; body mass index at admission , 23.4 kg/m2 ( at study day , 30.6 kg/m2 ) . The characteristics of the reference group were : age , 49 years ; male/female ratio , 6/1 ; body mass index at admission , 24.8 kg/m2 ( at study day , 25.0 kg/m2 ) . In the index group , creatinine clearance was lower compared to the reference group ( 71 versus 131 ml/minute , p = 0.003 ) . Sequential organ failure assessment score did not differ between index and reference groups ( 4 versus 5 ) . Mean arterial pressure was comparable between index and reference groups ( 91 versus 95 mmHg ) and within the normal range . The mean Cmax value was not different between ICU patients with and without subcutaneous oedema ( 0.15 ± 0.02 versus 0.14 ± 0.02 IU/ml , p = 0.34 ) . In the index group , the mean AUC(0–24 h ) value was slightly higher compared with the reference group ( 1.50 ± 0.31 versus 1.15 ± 0.25 h·IU/ml , p = 0.31 ) . This difference was not significant . Conclusion In this pilot study , there was no clinical ly relevant difference in anti-Xa activity after subcutaneous administration of 2,500 IU dalteparin for venous thromboembolism prophylaxis between ICU patients with and without subcutaneous oedema . Critically ill patients seem to have lower anti-Xa activity levels than healthy volunteers BACKGROUND Deep venous thromboses ( DVT ) continue to cause significant morbidity in critically ill patients . St and ard prophylaxis for high risk patients includes twice-daily dosing with 30 mg enoxaparin . Despite prophylaxis , DVT rates still exceed 10 % to 15 % . Anti-Xa levels are used to measure the activity of enoxaparin and 12-hour trough levels < or=0.1 IU/mL have been associated with higher rates of DVT in orthopedic patients . We hypothesized that low Anti-Xa levels would be found in critically ill trauma and surgical patients and that low levels would be associated with higher rates of DVT . METHODS All patients on the surgical intensive care unit ( ICU ) service were prospect ively followed . In the absence of contraindications , patients were given prophylactic enoxaparin and anti-Xa levels were drawn after the third dose . Trough levels < or=0.1 IU/mL were considered low . Screening duplex exams were obtained within 48 hours of admission and then weekly . Patients were excluded if they did not receive a duplex , if they had a prior DVT , or if they lacked correctly timed anti-Xa levels . DVT rates and demographic data were compared between patients with low and normal anti-Xa levels . RESULTS Data were complete for 54 patients . Eighty-five percent suffered trauma ( Injury Severity Score of 25 + /- 12 ) and 74 % were male . Overall , 27 patients ( 50 % ) had low anti-Xa levels . Patients with low anti \n Output:\n " }, { "from": "agent", "value": "Of note , none of the studies detected any correlation with bleeding events and anti-FXa levels .\nBased on the current literature , no definite conclusions can be drawn on targeted anti-FXa level in critically ill patients when using LMWH thromboprophylaxis" } ]

[ { "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 Gene expression signatures indicative of tumor proliferative capacity and tumor-immune cell interactions have emerged as principal biology-driven predictors of breast cancer outcomes . How these signatures relate to one another in biological and prognostic context s remains to be clarified . Results To investigate the relationship between proliferation and immune gene signatures , we analyzed an integrated data set of 1,954 clinical ly annotated breast tumor expression profiles r and omized into training and test sets to allow two-way discovery and validation of gene-survival associations . Hierarchical clustering revealed a large cluster of distant metastasis-free survival-associated genes with known immunological functions that further partitioned into three distinct immune metagenes likely reflecting B cells and /or plasma cells ; T cells and natural killer cells ; and monocytes and /or dendritic cells . A proliferation metagene allowed stratification of cases into proliferation tertiles . The prognostic strength of these metagenes was largely restricted to tumors within the highest proliferation tertile , though intrinsic subtype-specific differences were observed in the intermediate and low proliferation tertiles . In highly proliferative tumors , high tertile immune metagene expression equated with markedly reduced risk of metastasis whereas tumors with low tertile expression of any one of the three immune metagenes were associated with poor outcome despite higher expression of the other two metagenes . Conclusions These findings suggest that a productive interplay among multiple immune cell types at the tumor site promotes long-term anti-metastatic immunity in a proliferation-dependent manner . The emergence of a subset of effective immune responders among highly proliferative tumors has novel prognostic ramifications CONTEXT Prediction of high probability of survival from st and ard cancer treatments is fundamental for individualized cancer treatment strategies . OBJECTIVE To develop a predictor of response and survival from chemotherapy for newly diagnosed invasive breast cancer . DESIGN , SETTING , AND PATIENTS Prospect i ve multicenter study conducted from June 2000 to March 2010 at the M. D. And erson Cancer Center to develop and test genomic predictors for neoadjuvant chemotherapy . Patients were those with newly diagnosed ERBB2 ( HER2 or HER2/neu)-negative breast cancer treated with chemotherapy containing sequential taxane and anthracycline-based regimens ( then endocrine therapy if estrogen receptor [ER]-positive ) . Different predictive signatures for resistance and response to preoperative ( neoadjuvant ) chemotherapy ( stratified according to ER status ) were developed from gene expression microarrays of newly diagnosed breast cancer ( 310 patients ) . Breast cancer treatment sensitivity was then predicted using the combination of signatures for ( 1 ) sensitivity to endocrine therapy , ( 2 ) chemoresistance , and ( 3 ) chemosensitivity , with independent validation ( 198 patients ) and comparison with other reported genomic predictors of chemotherapy response . MAIN OUTCOME MEASURES Distant relapse-free survival ( DRFS ) if predicted treatment sensitive and absolute risk reduction ( [ ARR ] , difference in DRFS between 2 predicted groups ) at median follow-up ( 3 years ) . RESULTS Patients in the independent validation cohort ( 99 % clinical stage II-III ) who were predicted to be treatment sensitive ( 28 % ) had 56 % ( 95 % CI , 31%-78 % ) probability of excellent pathologic response and DRFS of 92 % ( 95 % CI , 85%-100 % ) , with an ARR of 18 % ( 95 % CI , 6%-28 % ) . Survival was predicted in ER-positive ( 30 % predicted sensitive ; DRFS , 97 % [ 95 % CI , 91%-100 % ] ; ARR , 11 % [ 95 % CI , 0.1%-21 % ] ) and ER-negative ( 26 % predicted sensitive ; DRFS , 83 % [ 95 % CI , 68%-100 % ] ; ARR , 26 % [ 95 % CI , 4%-48 % ] ) subsets and was significant in multivariate analysis . Other genomic predictors showed paradoxically worse survival for patients predicted to be responsive to chemotherapy . CONCLUSION A genomic predictor combining ER status , predicted chemoresistance , predicted chemosensitivity , and predicted endocrine sensitivity identified patients with high probability of survival following taxane and anthracycline chemotherapy \n Output:\n " }, { "from": "agent", "value": "However , high SIX3 mRNA level was a protective factor for OS and RFS of basal-like breast cancer patients .Our study suggested that members of SIX family played distinct roles in breast 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: Objective : To evaluate joint task force criteria -based screening for severe obstructive sleep apnea ( s-OSA ) in commercial drivers . Methods : Among a community-based cohort of licensed commercial vehicle drivers , we assessed utility of the joint task force criteria . We conducted full , 14-channel overnight polysomnography in all drivers , defining s-OSA as an apnea – hypopnea index of 30 or more per hour . Results : One hundred of 104 drivers with successful polysomnography studies were predominantly obese ( median body mass index = 32.8 kg/m2 ; interquartile range = 26.8 to 37.4 ) and had a median apnea — hypopnea index of 20.6 per hour ( interquartile range = 10.0 to 34.2 ) . Examination-based criteria were more effective ( sensitivity = 80 % ; negative posttest probability [ nPTP ] = 17 % ) than symptom-based criteria ( sensitivity = 63 % ; nPTP = 23 % ) . Examination and symptom-based criteria combined had high sensitivity ( 97 % ) and low nPTP ( 7 % ) , but poor specificity ( 19 % ) . Conclusions : Examination-based criteria missed 20 % of s-OSA cases . Combining examination with confidentially reported symptoms improved sensitivity but required confirmatory polysomnography in 86 % , supporting universal screening of all drivers Introduction Home respiratory polygraphy ( HRP ) may be a cost-effective alternative to polysomnography for the diagnosis of sleep apnoea-hypopnoea syndrome ( SAHS ) , but stronger evidence is needed . Normally , patients transport HRP equipment from the hospital to home and back , which may create difficulties for some patients . Objectives To determine both the diagnostic efficacy and cost of HRP ( with and without a transportation service moving the device and telematic transmission of data ) in a large sample compared with in-hospital polysomnography . Methods Patients suspected of having SAHS were included in a multicentre study ( eight hospitals ) . They were assigned to home and hospital protocol s in r and om order . Receiver operating characteristic curves were constructed for manual respiratory polygraphy scoring protocol and different polysomnographic cut-off points . Diagnostic efficacies for several polysomnographic cut-off points were explored and costs for two equally effective alternatives were calculated . Results Of 366 r and omised patients , 348 completed the protocol . The best receiver operating characteristic curve was obtained with a polysomnographic cut-off of the apnoea-hypopnoea index (AHI)≥5 . The sensitive HRP AHI cut-off point ( < 5 ) had a sensitivity of 96 % , a specificity of 57 % and a negative likelihood ratio ( LR ) of 0.07 ; the specific cut-off ( > 10 ) had a sensitivity of 87 % , a specificity of 86 % and a positive LR of 6.25 . The cost of HRP was half that of polysomnography . Telematic transmission costs were similar if the patients ' costs were taken in to account . Conclusion HRP is an alternative to polysomnography in patients with suspected SAHS . Telematic procedures may help patients with limited mobility and those who live a long way from the sleep centre BACKGROUND Obstructive sleep apnea hypopnea syndrome ( OSAHS ) is underdiagnosed . Screening patients at high risk of OSAHS is extremely important . Using the st and ard question naire to screen OSAHS is a practical method . This study aim ed to evaluate the value of the STOP-Bang question naire ( SBQ ) in screening OSAHS in sleep-disordered breathing clinic by comparing it with the Epworth sleepiness scales ( ESS ) , Berlin question naire , and STOP question naire . METHODS In this study , 212 patients at the sleep-disordered breathing clinic of the Peking Union Medical College Hospital between May 2011 and January 2012 were prospect ively included . They were asked to fill in the SBQ , ESS , Berlin question naire , and STOP question naire before overnight polysomnography ( PSG ) . Using PSG as gold st and ard , the sensitivities and specificities of SBQ were compared with those of ESS , Berlin question naire , and STOP question naire . RESULTS There was no significance in applying ESS score ≥11 to screen OSAHS and detect moderate and severe OSAHS ( P > 0.05 ) . SBQ was superior to Berlin question naire and STOP question naire in screening OSAHS and detecting the severity of OSAHS patients . The sensitivities of SBQ score ≥3 with apnea hypopnea index ( AHI ) ≥5/h , AHI ≥15/h , and AHI ≥30/h as gold st and ards were 94.9 % , 96.5 % , and 97.7 % , respectively . The specificities were 50.0 % , 28.6 % , and 17.9 % , respectively . The area upper curves were 0.815 ( 0.706 - 0.925 , P < 0.01 ) , 0.746 ( 0.665 - 0.828 , P < 0.01 ) , and 0.751 ( 0.686 - 0.817 , P < 0.01 ) , respectively . According to SBQ , the population was classified into high-risk group and low-risk group . The gender , BMI , neck circumference , AHI , LSpO2 , and number of subjects of AHI ≥5/h , AHI ≥15/h , and AHI ≥30/h of these two groups were significantly different . CONCLUSIONS The SBQ has superior predictive value compared with ESS , Berlin question naire , and STOP question naire . It should be used further in screening for OSAHS in the general population STUDY OBJECTIVES To test the utility of an integrated clinical pathway for obstructive sleep apnea ( OSA ) diagnosis and continuous positive airway pressure ( CPAP ) treatment using portable monitoring devices . DESIGN R and omized , open-label , parallel group , unblinded , multicenter clinical trial comparing home-based , unattended portable monitoring for diagnosis and autotitrating CPAP ( autoPAP ) compared with in-laboratory polysomnography ( PSG ) and CPAP titration . SETTING Seven American Academy of Sleep Medicine ( AASM ) accredited sleep centers . PARTICIPANTS Consecutive new referrals , age 18 yr or older with high probability of moderate to severe OSA ( apnea-hypopnea index [ AHI ] ≥ 15 ) identified by clinical algorithm and Epworth Sleepiness Scale ( ESS ) score ≥ 12 . INTERVENTIONS Home-based level 3 testing followed by 1 wk of autoPAP with a fixed pressure CPAP prescription based on the 90 % pressure from autotitration of PAP therapy ( autoPAP ) device ( HOME ) compared with attended , in-laboratory studies ( LAB ) . MEASUREMENTS CPAP acceptance , time to treatment , adherence at 1 and 3 mo ; changes in ESS , and functional outcomes . RESULTS Of 373 participants , approximately one-half in each study arm remained eligible ( AHI ≥ 15 ) to continue in the study . At 3 mo , PAP usage ( nightly time at pressure ) was 1 hr greater : 4.7 ± 2.1 hr ( HOME ) compared with 3.7 ± 2.4 hr ( LAB ) . Adherence ( percentage of night used ≥ 4 hr ) was 12.6 % higher : 62.8 ± 29.2 % compared with 49.4 ± 36.1 % in the HOME versus LAB . Acceptance of PAP therapy , titration pressures , effective titrations , time to treatment , and ESS score change did not differ between arms . CONCLUSIONS A home-based strategy for diagnosis and treatment compared with in-laboratory PSG was not inferior in terms of acceptance , adherence , time to treatment , and functional improvements . TRIAL REGISTRATION http://www . Clinical Trials.gov ; Identifier : NCT : 00642486 A simple screening method for sleep-disordered breathing ( SDB ) is desirable for primary care practice s. In the present study , a simple monitor , which utilises a new type of flow sensor and a novel algorithm , was prospect ively vali date d. Home recording for 2 nights with the monitor only , followed by in-laboratory recording with the monitor together with polysomnography , were carried out in consecutive patients ( n = 100 ) suspected of SDB . A subjective sleep log was also recorded . The signal was analysed using power spectral analysis , which yielded the flow respiratory disturbance index ( flow-RDI ) . There was no recording failure at home . The reproducibility of the flow-RDI between the 2 nights at home was high ( intraclass correlation coefficient = 0.92 ) . The sensitivity and specificity of the in-laboratory flow-RDI to diagnose SDB were 0.96 and 0.82 , 0.91 and 0.82 , and 0.89 and 0.96 , for apnoea/hypopnoea index ( AHI ) ≥5 , ≥15 and ≥30 events·h−1 , respectively . The diagnostic ability in low-severity subgroups ( female , normal weight , AHI < 15 events·h−1 ) was almost comparable to that in the entire group . Excluding subjective waking time on the sleep log from the recording time had no significant effect on the flow-RDI . The single-channel monitor is considered feasible for ambulatory sleep disordered breathing monitoring because of its easy applicability , high reproducibility and relatively high agreement with polysomnography results OBJECTIVES This study aims to assess the reliability of SleepStrip as a screening test in obstructive sleep apnea syndrome ( OSAS ) . PATIENTS AND METHODS Seventy-two patients ( 50 males , 22 females ; mean age 51.4±11.1 years ; range 20 to 74 years ) with OSAS were included in this prospect i ve , non-r and omized double-blinded single cohort study between May 2008 and February 2009 . Patients who underwent an attended overnight polysomnography ( PSG ) and consented to participate in the study were asked to use SleepStrip device within the week following PSG recording . The apnea-hypopnea index ( AHI ) was compared with the SleepStrip score ( Sscore ) . RESULTS The mean body mass index of patients was 31.1±4.3 . Both AHI and Sscore were obtained in 64 patients . There was a strong correlation between Sscore and AHI ( r=0.76 , p<0.001 ) . The sensitivity and specificity of the SleepStrip were 94.4 % and 93.5 % when used to diagnose cases with AHI = or > 40 . The sensitivity and specificity of the SleepStrip was reduced to 80 % and 87.2 % when AHI threshold was chosen as = or > 25 and 83.3 % and 76.5 % for AHI = or > 15 respectively . CONCLUSION There is a strong correlation between SleepStrip and AHI . SleepStrip was found to be effective in diagnosing severe OSAS with AHI = or > 40 , however , its diagnostic capability was reduced in patients with lower AHI 's who constitute the main target of screening BACKGROUND The STOP-Bang question naire is a vali date d screening tool for the identification of surgical patients with obstructive sleep apnea ( OSA ) . A STOP-Bang score ≥ 3 is highly sensitive but only moderately specific . Apnea/hypopnea during sleep can lead to intermittent hypercapnia and may result in serum bicarbonate ( HCO₃⁻ ) retention . The addition of serum HCO₃⁻ level to the STOP-Bang question naire may improve its specificity . METHODS Four thous and seventy-seven preoperative patients were approached for consent and screened by the STOP-Bang question naire . Polysomnography was performed and preoperative HCO₃⁻ level was collected in 384 patients . Study participants were r and omly assigned to a derivation or validation cohort . Predictive parameters ( sensitivity , specificity , positive and negative predictive values ) for STOP-Bang score and serum HCO₃⁻ level were calculated . RESULTS In the derivation cohort , with a STOP-Bang score ≥ 3 , the specificity for all OSA , moderate/severe OSA , and severe OSA was 37.0 % , 30.4 % , and 27.7 % , respectively . HCO₃⁻ level of 28 mmol/L was selected as a cutoff for analysis . With the addition of HCO₃⁻ level ≥ 28 mmol/L to the STOP-Bang score ≥ 3 , the specificity for all OSA , moderate/severe OSA , and severe OSA improved to 85.2 % , 81.7 % , and 79.7 % , respectively . Similar improvement was observed in the validation cohort . CONCLUSION Serum HCO₃⁻ level increases the specificity of STOP-Bang screening in predicting moderate/severe OSA . We propose a two-step screening process . The first step uses a STOP-Bang score to screen patients , and the second step uses serum HCO₃⁻ level in those with a STOP-Bang score ≥ 3 for increased specificity The obstructive sleep apnea syndrome ( OSAS ) is a sleep disorder associated with excessive day-time sleepiness ; sleep fragmentation ; intermittent hypoxia ; and increased risk for diurnal hypertension , myocardial infa rct ion , ventricular failure , pulmonary hypertension , cardiac dysrhythmias \n Output:\n " }, { "from": "agent", "value": "A WEAK recommendation reflects a lower degree of certainty regarding the outcome and appropriateness of the patient-care strategy for all patients .\nPolysomnography is the st and ard diagnostic test for the diagnosis of OSA in adult patients in whom there is a concern for OSA based on a comprehensive sleep 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: OBJECTIVES To evaluate the effectiveness of a multifactorial intervention to reduce the use of physical restraints in residents of nursing homes . DESIGN Cluster-r and omized controlled trial . SETTING Forty-five nursing homes in Germany . PARTICIPANTS Three hundred thirty-three residents who were being restrained at the start of the intervention . INTERVENTION Persons responsible for the intervention in the nursing homes attended a 6-hour training course that included education about the reasons restraints are used , the adverse effects , and alternatives to their use . Technical aids , such as hip protectors and sensor mats , were provided . The training was design ed to give the change agents tools for problem-solving to prevent behavioral symptoms and injuries from falls without using physical restraints . MEASUREMENTS The main outcome was the complete cessation of physical restraint use on 3 consecutive days 3 months after the start of the intervention . Secondary outcomes were partial reductions in restraint use , percentage of fallers , number of psychoactive drugs , and occurrence of behavioral symptoms . RESULTS The probability of being unrestrained in the intervention group ( IG ) was more than twice that in the control group ( CG ) at the end of the study ( odds ratio=2.16 , 95 % confidence interval=1.05 - 4.46 ) . A partial reduction of restraint use was also about twice as often achieved in the IG as in the CG . No negative effect was observed regarding medication or behavioral symptoms . The percentage of fallers was higher in the IG . CONCLUSION The intervention reduced restraint use without a significant increase in falling , behavioral symptoms , or medication At present , observational studies and expert opinion are the best evidence for the use of physical restraints . Large regional and national disparities are described in acute and long-term care . Epidemiological data demonstrate a prevalence of 3 - 5 % body-fixed or near body restraint devices . The hip fracture rate in Germany are approximately 50 per 1000 resident years . Between 40 - 50 % of the residents in nursing homes are treated with psycho-tropic medication potentially limiting their physical mobility . The presented study protocol was design ed to test the effectiveness of a multifactorial intervention to reduce physical restraints in long-term care ( LTC ) residents particularly with cognitive impairment . The intervention consists of an educational and an organizational part to empower staff members to improve their skills and practice in using restraints . Technical devices to reduce fall related injuries are additionally offered to the LTC facilities . The study population includes 200 LTC residents in 54 facilities in three states in Germany . The sample size calculation was based upon a 5 % prevalence rate in the control group and an expected reduction of 50 % in the intervention group . The protocol is a waiting-list control design . All waiting facilities will be offered to participate after their waiting period . Primary endpoints are the number of restrained residents and resident time ( hours ) of being restrained . The use of psychotropics , falls , fall-related injuries and the incidence of residents newly being restrained is being monitored . The study starts with a baseline documentation of all facilities followed by r and omization and a three month intervention . Change agents will be responsible for the intervention . Technical devices will include a newly developed soft hip protector and sensor mats which notice the intent of leaving the bed . The aim of the study is to develop an evidence -based model for a knowledge transfer project to implement minimum restraint environments in LTC Background Physical restraints are regularly applied in German nursing homes . Their frequency varies substantially between centres . Beneficial effects of physical restraints have not been proven , however , observational studies and case reports suggest various adverse effects . We developed an evidence -based guidance on this topic . The present study evaluates the clinical efficacy and safety of an intervention programme based on this guidance aim ed to reduce physical restraints and minimise centre variations . Methods / Design Cluster-r and omised controlled trial with nursing homes r and omised either to the intervention group or to the control group with st and ard information . The intervention comprises a structured information programme for nursing staff , information material s for legal guardians and residents ' relatives and a one-day training workshop for nominated nurses . A total of 36 nursing home clusters including approximately 3000 residents will be recruited . Each cluster has to fulfil the inclusion criteria of at least 20 % prevalence of physical restraints at baseline . The primary endpoint is the number of residents with at least one physical restraint at six months . Secondary outcome measures are the number of falls and fall-related fractures . Discussion If successful , the intervention should be implemented throughout Germany . In case the intervention does not succeed , a three-month pre-post- study with an optimised intervention programme within the control group will follow the r and omised trial . Trial registration IS RCT The prevention of injury associated with falls in older people is a public health target in many countries around the world . Although there is good evidence that interventions such as multifactorial fall prevention and individually prescribed exercise are effective in reducing falls , the effect on serious injury rates is unclear . Historically , trials have not been adequately powered to detect injury endpoints , and variations in case definition across trials have hindered meta- analysis . It is possible that fall-prevention strategies have limited effect on falls that result in injuries or are ineffective in population s who are at a higher risk of injury . Further research is required to determine whether fall-prevention interventions can reduce serious injuries . Prevention of Falls Network Europe ( ProFaNE ) is a collaborative project to reduce the burden of fall injury in older people through excellence in research and promotion of best practice ( www.profane.eu.org ) . The European Commission funds the network , which links clinicians , members of the public , and research ers worldwide . The aims are to identify major gaps in knowledge in fall injury prevention and to facilitate the collaboration necessary for large-scale clinical research activity , including clinical trials , comparative research , and prospect i ve meta- analysis . Work is being undertaken in a 4-year program . As a first step , the development of a common set of outcome definitions and measures for future trials or meta- analysis was considered \n Output:\n " }, { "from": "agent", "value": "In our view , bedrails should not be excluded from PR , even if this is in accordance with other studies in the field .\nIn conclusion , we would have expected the authors to adhere to the study protocol even if this would have led to a nonsignificant result .\nRather than ‘ ‘ fishing for P-values , ’ ’ analyses of strengths and weaknesses of the program would have been of great significance even if not ‘ ‘ statistically significant . ’ ’" } ]

[ { "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 Epidemiologic evidence suggests that tomato-based products could reduce the risk of cardiovascular diseases . One of the main cardiovascular risk factors is low levels of high-density lipoprotein cholesterol ( HDL-C ) . This study aim ed to prospect ively evaluate the effect of tomato consumption on HDL-C levels . Subject and methods We conducted a r and omized , single-blinded , controlled clinical trial . We screened 432 subjects with a complete lipid profile . Those individuals with low HDL-C ( men < 40 mg/dL and women < 50 mg/dL ) but normal triglyceride levels ( < 150 mg/dL ) were included . Selected participants completed a 2-week run-in period on an isocaloric diet and then were r and omized to receive 300 g of cucumber ( control group ) or two uncooked Roma tomatoes a day for 4 weeks . Results A total of 50 individuals ( women = 41 ; 82 % ) with a mean age of 42 ± 15.5 years and a mean body mass index of 27.6 ± 5.0 kg/m2 completed the study . A significant increase in HDL-C levels was observed in the tomato group ( from 36.5 ± 7.5 mg/dL to 41.6 ± 6.9 mg/dL , P < 0.0001 versus the control group ) . After stratification by gender , the difference in HDL-C levels was only significant in women . The mean HDL-C increase was 5.0 ± 2.8 mg/dL ( range 1–12 mg/dL ) . Twenty patients ( 40 % ) finished the study with levels > 40 mg/dL. A linear regression model that adjusted for those parameters that impact HDL-C levels ( age , gender , waist-to-hip ratio , body mass index , fasting triglyceride concentration , simple sugars , alcohol , physical activity , and omega-3 consumption ) showed an independent association between tomato consumption and the increase in HDL-C ( r2 = 0.69 ; P < 0.0001 ) . Conclusion Raw tomato consumption produced a favorable effect on HDL-C levels in overweight women In addition to the inverse association of dietary lycopene with various cancers , studies suggest a role for lycopene in cardiovascular disease ( CVD ) prevention . We determined whether the intake of lycopene or tomato-based foods is associated with the risk of CVD in a prospect i ve cohort of 39,876 middle-aged and older women initially free of CVD and cancer . Participants completed a food-frequency question naire and provided self-reports of coronary risk factors . Dietary lycopene levels were divided into quintiles , and primary lycopene food sources ( total tomato-based products , including tomatoes , tomato juice , tomato sauce and pizza ) were categorized . During 7.2 y of follow-up , 719 CVD cases ( including myocardial infa rct ion , stroke , revascularization and CVD death ) occurred . Compared with women in the 1st quintile of lycopene , those in increasing quintiles had multivariate relative risks ( RR ) of CVD of 1.11 , 1.14 , 1.15 and 0.90 ( P for trend = 0.34 ) . For the consumption of tomato-based products , women consuming 1.5 to < 4 , 4 to < 7 , 7 to < 10 and > or=10 servings/wk had RR ( 95 % CI ) of CVD of 1.02 ( 0.82 - 1.26 ) , 1.04 ( 0.82 - 1.31 ) , 0.68 ( 0.49 - 0.96 ) and 0.71 ( 0.42 - 1.17 ) ( P for trend = 0.029 ) compared with women consuming < 1.5 servings/wk . Among lycopene food sources , those in the highest levels of tomato sauce ( > or=2 servings/wk ) and pizza intake ( > or=2 servings/wk ) , with multivariate RR of 0.76 ( 0.55 - 1.05 ) and 0.66 ( 0.37 - 1.18 ) , respectively , had potential reductions in CVD risk . Dietary lycopene was not strongly associated with the risk of CVD . However , the possible inverse associations noted for higher levels of tomato-based products , particularly tomato sauce and pizza , with CVD suggest that dietary lycopene or other phytochemicals consumed as oil-based tomato products confer cardiovascular benefits Aims The mechanisms by which a ‘ Mediterranean diet ’ reduces cardiovascular disease ( CVD ) burden remain poorly understood . Lycopene is a potent antioxidant found in such diets with evidence suggesting beneficial effects . We wished to investigate the effects of lycopene on the vasculature in CVD patients and separately , in healthy volunteers ( HV ) . Methods and Results We r and omised 36 statin treated CVD patients and 36 healthy volunteers in a 2∶1 treatment allocation ratio to either 7 mg lycopene or placebo daily for 2 months in a double-blind trial . Forearm responses to intra-arterial infusions of acetylcholine ( endothelium-dependent vasodilatation ; EDV ) , sodium nitroprusside ( endothelium-independent vasodilatation ; EIDV ) , and NG-monomethyl-L-arginine ( basal nitric oxide ( NO ) synthase activity ) were measured using venous plethysmography . A range of vascular and biochemical secondary endpoints were also explored . EDV in CVD patients post-lycopene improved by 53 % ( 95 % CI : + 9 % to + 93 % , P = 0.03 vs. placebo ) without changes to EIDV , or basal NO responses . HVs did not show changes in EDV after lycopene treatment . Blood pressure , arterial stiffness , lipids and hsCRP levels were unchanged for lycopene vs. placebo treatment groups in the CVD arm as well as the HV arm . At baseline , CVD patients had impaired EDV compared with HV ( 30 % lower ; 95 % CI : −45 % to −10 % , P = 0.008 ) , despite lower LDL cholesterol ( 1.2 mmol/L lower , 95 % CI : −1.6 to −0.9 mmol/L , P<0.001 ) . Post-therapy EDV responses for lycopene-treated CVD patients were similar to HVs at baseline ( 2 % lower , 95 % CI : −30 % to + 30 % , P = 0.85 ) , also suggesting lycopene improved endothelial function . Conclusions Lycopene supplementation improves endothelial function in CVD patients on optimal secondary prevention , but not in HVs . Trial Registration Clinical Trials.gov Epidemiological studies suggest that consumption of tomato products reduces the risk of CVD via antioxidant , hypocholesterolaemic and anti-inflammatory mechanisms . Although experimental data also describe beneficial effects on endothelial function , clinical data in human subjects are lacking . To test the hypothesis that tomato ingestion ameliorates endothelial function , we r and omised healthy non-smoking postmenopausal women to consume a buttered roll with and without tomato purée ( 70 g ) in a cross-over design . Endothelial-dependent flow-mediated dilation ( FMD ) and endothelial-independent nitro-mediated dilation of the brachial artery were assessed with high-resolution ultrasound ( 13 MHz linear array transducer ) . Acute ( 24 h ) and long-term ( 7 d ) effects were examined after daily consumption of the described meal . Nineteen volunteers completed the protocol and provided technically suitable ultrasound measurement data . Plasma lycopene levels increased from 0·30 ( sem 0·04 ) ( baseline ) to 0·42 ( sem 0·04 ) and to 0·74 ( sem 0·06 ) μm after 24 h and 7 d , respectively , with tomato purée consumption . These data indicated an effective absorption of the tomato product . However , both acute and long-term tomato purée consumption had no effects on endothelium-dependent or -independent dilation of the brachial artery . In addition , we found no correlation between lycopene plasma levels and FMD . In conclusion , consumption of tomato products associated with a significant increase in plasma lycopene levels had no effects on endothelial function in healthy postmenopausal women It is well established that exercise induces excessive production of reactive species leading to oxidative stress , which has been implicated in oxidative damage of macromolecules , immune dysfunction , muscle damage and fatigue . The present study examined the effect of supplementation of ultra-marathon runners for a two-months-period with a special whey protein bar containing carbohydrates and protein in a specific ratio ( 1:1 ) ( N=16 ) , prepared using as starting material the by-products of cheese manufacturing , and supplementation with commercially available tomato juice ( N=15 ) . Thiobarbituric-acid reactive substances and protein carbonyls were significantly decreased in both supplementation groups , while a pronounced increased in reduced glutathione was observed in the protein bar group . Total anti-oxidant activity remained unchanged in both groups . Flow-mediated dilatation , used as an estimate of endothelial function , was increased in both groups , with a significant rise observed only in the tomato juice administration group . In conclusion , supplementation of ultra marathon runners for a two-months-period with a special protein bar and tomato juice significantly improved the oxidative status of the subjects , while tomato juice also improved vascular endothelial function in these athletes Consumption of tomato products is linked to beneficial outcomes through antioxidant and anti-inflammatory mechanisms . The aim of this study was to determine whether a 14-day period of tomato paste supplementation would improve endothelial function . Nineteen volunteers ( mean age , 39 ± 13 years ; 8 men/11 women ) were studied in a r and omized ( exposure sequence ) , single-blind ( operator ) , crossover design . The study consisted of a supplementation arm ( 70 g tomato paste containing 33.3 mg of lycopene ) and a control arm , during which no tomato paste was added to their regular diet . Volunteers maintained their regular diet during study arms . Two-week washout periods preceded each arm . Flow-mediated dilatation ( FMD ) measured by brachial artery ultrasonography was used as an estimate of endothelial function at day 1 ( acute response ) and day 15 ( midterm response ) . Plasma lipid peroxides were measured with a photometric enzyme-linked immunosorbent assay as an index of total oxidative status . Tomato supplementation led to an overall FMD increase compared with the control period ( P = .047 for repeated- measures 3 × 2 analysis of variance ) . At day 1 , FMD was not significantly increased ( P = .329 ) . By day 15 , tomato supplementation result ed in an increase in FMD by 3.3 % ± 1.4 % , whereas at the control arm , FMD declined by -0.5 % ± 0.6 % ( P = .03 ) ; magnitudes of change are absolute FMD values . Total oxidative status decreased at the end of the supplementation period compared with baseline values ( P = .038 ) . Daily tomato paste consumption exerts a beneficial midterm but not short-term effect on endothelial function . Further studies are warranted to explore the effects of tomato paste on endothelial dilation in different age groups and comorbidities AIM Menopause is a pro-atherogenic state with a sharp rise in the incidence of coronary artery disease . This pilot study was design ed as an equivalence r and omized clinical trial to explore the potential of LycoRed ( containing 2000 microg lycopene ) as an alternative to hormone replacement therapy ( HRT ) for the prevention of coronary artery disease in postmenopausal women . METHODS Forty-one healthy postmenopausal women were r and omly allocated to receive either continuous combined HRT ( n = 21 ) or LycoRed ( n = 20 ) for six months . Serum lipid profile , marker of lipid peroxidation ( malondialdehyde ) , and the level of endogenous antioxidant ( glutathione ) were measured at the baseline , and 3 and 6 months after the intervention in both groups . RESULTS At 6 months , HRT result ed in a significant decrease in total cholesterol ( TC ) level by 23.5 % , low-density lipoproteins ( LDL ) by 19.6 % , and an increase in high-density lipoproteins ( HDL ) by 38.9 % . The LycoRed group showed similar changes in TC ( -24.2 % ) , LDL ( -14.9 % ) and HDL ( + 26.1 % ) . Triglyceride levels showed a smaller though significant increase at 6 months , but not at 3 months , in both groups . There was no significant change in the very LDL ( VLDL ) level in either group . Malondialdehyde levels decreased significantly by 16.3 % and 13.3 % , whereas glutathione levels increased significantly by 5.9 % and 12.5 % in HRT and LycoRed groups , respectively . CONCLUSION Both HRT and LycoRed had a favorable effect on serum lipids and oxidative stress markers which were comparable . LycoRed can be used as an alternative to \n Output:\n " }, { "from": "agent", "value": "No other outcome was significantly affected by these interventions .\nThe available evidence on the effects of tomato products and lycopene supplementation on CV risk factors supports the view that increasing the intake of these has positive effects on blood lipids , blood pressure and endothelial function .\nThese results support the development of promising individualised nutritional strategies involving tomatoes to tackle CVD" } ]

[ { "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: Since its inception during the severe outbreak of poliomyelitis almost 50 years ago , the intensive care unit ( ICU ) has become a key feature in almost every hospital . Increasingly sick patient population s , improved life-support systems , newer , more effective therapeutic agents , and greater underst and ing of the pathophysiology of many disease processes have led to a growing need for ICU beds , with the ICU increasingly accounting for a larger and larger proportion of the hospital budget [ 1 ] . Intensive care is un question ably expensive care [ 2 , 3 ] and re sources are not always readily available . As an example , there are frequently insufficient ICU beds available to cater for dem and . Indeed , in a recent question naire survey of 504 ICUs in 16 Western European countries , 46 % of respondents stated that ICU admissions were generally or commonly affected by bed shortages [ 4 ] . With increasingly expensive technology being developed , ICU spending is likely further to exceed available funding , and the need for explicit rationing is rapidly becoming a reality . However rationing is applied , the aim must be to provide , without restriction , high- quality intensive care for those who will benefit from it . To this end , several suggestions have been made to limit ICU costs and improve the efficiency of the service . These include the development and implementation of strict admission and discharge criteria , and the use of intermediate care units . These intermediate care units , also termed high-dependency or astepdowno , units , generally have a higher nurse/patient ratio and greater facilities for intensive monitoring than would be found on a general ward , but fewer staff and less invasive equipment than on an ICU [ 5 , 6 ] ( Fig. 1 ) . Such areas cater for patients who do not require full ICU care but are thought to need more care than could be offered on the general ward . Intermediate care units have been adopted by some hospitals , particularly for specific patient groups , such as cardiac [ 7 ] , neurosurgical [ 8 ] , or respiratory [ 9 ] patients . The use of such units has been promoted as a means of enabling the earlier discharge of some ICU patients and of providing an alternative to intensive care for patients who merely require intensive monitoring , thus freeing ICU beds . However , such units are not necessarily the solution to overutilization of ICU beds and may merely divert the issue rather than solve it [ 10 ] . They may also have negative effects on patient care and staff morale . Importantly , there are few , if any , prospect i ve studies on the benefits of intensive care versus intermediate care which provide objective and hence comparable , admission and discharge criteria . In addition , the literature that is available comes predominantly from the United States , where intensive care training , organisation and management are very different than Europe . In this paper , we will discuss the pros and cons of intermediate care units and conclude with our thoughts and recommendations on the appropriate place of such units in our hospitals today Introduction The aim of the study was to assess whether adults admitted to hospitals with both Intensive Care Units ( ICU ) and Intermediate Care Units ( IMCU ) have lower in-hospital mortality than those admitted to ICUs without an IMCU . Methods An observational multinational cohort study performed on patients admitted to participating ICUs during a four-week period . IMCU was defined as any physically and administratively independent unit open 24 hours a day , seven days a week providing a level of care lower than an ICU but higher than a ward . Characteristics of hospitals , ICUs and patients admitted to study ICUs were recorded . The main outcome was all-cause in-hospital mortality until hospital discharge ( censored at 90 days ) . Results One hundred and sixty-seven ICUs from 17 European countries enrolled 5,834 patients . Overall , 1,113 ( 19.1 % ) patients died in the ICU and 1,397 died in hospital , with a total of 1,397 ( 23.9 % ) deaths . The illness severity was higher for patients in ICUs with an IMCU ( median Simplified Acute Physiology Score ( SAPS ) II : 37 ) than for patients in ICUs without an IMCU ( median SAPS II : 29 , P < 0.001 ) . After adjustment for patient characteristics at admission such as illness severity , and ICU and hospital characteristics , the odds ratio of mortality was 0.63 ( 95 % CI 0.45 to 0.88 , P = 0.007 ) in favour of the presence of IMCU . The protective effect of the IMCU was absent in patients who were admitted for basic observation , for example , after surgery ( odds ratio 1.15 , 95 % CI 0.65 to 2.03 , P = 0.630 ) but was strong in patients admitted to an ICU for other reasons ( odds ratio 0.54 , 95 % CI 0.37 to 0.80 , P = 0.002 ) . Conclusions The presence of an IMCU in the hospital is associated with significantly reduced adjusted hospital mortality for adults admitted to the ICU . This effect is relevant for the patients requiring full intensive treatment . Trial registration Clinical trials.gov NCT01422070 . Registered 19 August 2011 Objective To evaluate short- and long-term outcomes of elderly patients ( ≥ 65 years ) treated at an intermediate care unit ( IMCU ) and to identify outcome predictors . Design and setting Prospect i ve observational study in the IMCU of a university teaching hospital . Participants We studied 412 patients over 8 months , classified into three groups : under 65 years ( control group , n = 158 ) , 65–80 ( n = 186 ) , and > 80 ( n = 68 ) . Measurements At admission : APACHE II , TISS-28 first day , Charlson Index , diagnosis , and prior Barthel Index . Outcome measures : in-hospital mortality , length of stay , discharge destination , and 2-year mortality and readmissions . Data analysis included multivariate logistic regression and receiver operating characteristics area under the curve ( ROC AUC ) . Results No statistically significant differences between groups were observed in hospital mortality ( 14.1 % ) , discharge to a long-term facility ( 2.7 % ) , or 2-year readmissions ( 1.2 ± 2.1 ) . However , hospital stay was longer in patients aged 65–80 years ( 14 vs.10 days ) and 2-year mortality was higher in those 65 or over ( 34 % vs.10.6 % ) . In the overall series in-hospital mortality was predicted by APACHE II , first-day TISS-28 , and diagnosis ( ROC AUC 0.81 ) , and 2-year mortality by Charlson Index and age ( ROC AUC 0.77 ) . In the elderly patients 2-year mortality was predicted by Charlson and Barthel indices ( ROC AUC 0.70 ) . Conclusions Illness severity and therapeutic intervention at admission to IMCU were predictors of short-term mortality , whereas the strongest predictor of long-term mortality was comorbidity . Our results suggest that comprehensive assessment of elderly patients at admission to IMCUs may improve outcome prediction Objectives : Cardiorespiratory instability may be undetected in monitored step-down unit patients . We explored whether using an integrated monitoring system that continuously amalgamates single noninvasive monitoring parameters ( heart rate , respiratory rate , blood pressure , and peripheral oxygen saturation ) into AN instability index value ( INDEX ) correlated with our single-parameter cardiorespiratory instability concern criteria , and whether nurse response to INDEX alert for patient attention was associated with instability reduction . Design : Prospect i ve , longitudinal evaluation in sequential 8- , 16- , and 8-wk phases ( phase I , phase II , and phase III , respectively ) . Setting : A 24-bed trauma step-down unit in single urban tertiary care center . Patients : All monitored patients . Interventions : Phase I : Patients received continuous single-channel monitoring ( heart rate , respiratory rate , blood pressure , and peripheral oxygen saturation ) and st and ard care ; INDEX background was recorded but not displayed . Phase II : INDEX was background -recorded ; staff was educated on use . Phase III : Staff used a clinical response algorithm for INDEX alerts . Measurement and Main Results : Any monitored parameters even transiently beyond local cardiorespiratory instability concern triggers ( heart rate of < 40 or > 140 beats/min , respiratory rate of < 8 or > 36 breaths/min , systolic blood pressure of < 80 or > 200 mm Hg , diastolic blood pressure of > 110 mm Hg , and peripheral oxygen saturation of < 85 % ) defined INSTABILITYmin . INSTABILITYmin further judged as both persistent and serious defined INSTABILITYfull . The INDEX alert states were defined as INDEXmin and INDEXfull by using same classification . Phase I and phase III admissions ( 323 vs. 308 ) and monitoring ( 18,258 vs. 18,314 hrs ) were similar . INDEXmin and INDEXfull correlated significantly with INSTABILITYmin and INSTABILITYfull ( r = .713 and r = .815 , respectively , p < .0001 ) . INDEXmin occurred before INSTABILITYmin in 80 % of cases ( mean advance time 9.4 ± 9.2 mins ) . Phase I and phase III admissions were similarly likely to develop INSTABILITYmin ( 35 % vs. 33 % ) , but INSTABILITYmin duration /admission decreased from phase I to phase III ( p = .018 ) . Both INSTABILITYfull episodes/admission ( p = .03 ) and INSTABILITYfull duration /admission ( p = .05 ) decreased in phase III . Conclusion : The integrated monitoring system INDEX correlated significantly with cardiorespiratory instability concern criteria , usually occurred before overt instability , and when coupled with a nursing alert was associated with decreased cardiorespiratory instability concern criteria in step-down unit patients BACKGROUND Patients in step-down units are at higher risk for developing cardiorespiratory instability than are patients in general care areas . A triage tool is needed to identify at-risk patients who therefore require increased surveillance . OBJECTIVES To determine demographic ( age , race , sex ) and clinical ( Charlson Comorbidity Index at admission , admitting diagnosis , care area of origin , admission service ) differences between patients in step-down units who did and did not experience cardiorespiratory instability . METHODS In a prospect i ve longitudinal pilot study , 326 surgical-trauma patients had continuous monitoring of heart rate , respirations , and oxygen saturation and intermittent noninvasive measurement of blood pressure . Cardiorespiratory instability was defined as heart rate less than 40/min or greater than 140/min , respirations less than 8/min or greater than 36/min , oxygen saturation less than 85 % , or blood pressure less than 80 or greater than 200 mm Hg systolic or greater than 110 mm Hg diastolic . Patients ' status was classified as unstable if their values crossed these thresholds even once during their stay . RESULTS Cardiorespiratory instability occurred in 34 % of patients . The Charlson Comorbidity Index was the only variable associated with instability conditions . Compared with patients with no comorbid conditions ( 50 % ) , more patients with at least 1 comorbid condition ( 66 % ) experienced instability ( P = .006 ) . Each 1-unit increase in the Charlson Index increased the odds for cardiorespiratory instability by 1.17 ( P = .03 ) . CONCLUSION Although the relationship between Charlson Comorbidity Index and cardiorespiratory instability was weak , adding it to current surveillance systems might improve detection of instability BACKGROUND : The medium care unit ( MCU ) or “ stepdown ” unit is an increasingly important , but understudied care environment . With an aging population and more patients with complex multiple diseases , many patients often require a higher level of inpatient care even when full intensive care is not indicated . However , the nurse-to-patient ratio required on a MCU is neither well defined nor clear whether this ratio should be adjusted per shift . The Nursing Activities Score ( NAS ) is an effective instrument for measuring nursing workload in the intensive care unit ( ICU ) but has not been used in an MCU . The aim of this study was to measure the nursing workload per 8-hour shift on an MCU using the NAS and compare it with the NAS from an ICU in the same hospital . We also compared the NAS between groups of patients with different admission sources . METHODS : The NAS was prospect ively measured per patient per shift for 2 months in a 9-bed tertiary referral university hospital MCU and during a similar period in an ICU in the same hospital . RESULTS : The mean NAS per patient did not differ between day ( 7:30 AM to 4:00 PM ) and evening ( 3:00 PM to 11:30 PM ) shifts , but the NAS was significantly lower during the night shift ( 11:00 PM to 8:00 AM ) than during the day ( P < 0.0001 ) and evening ( P < 0.0001 ) shifts . The mean NASs in the ICU for day and night shifts were significantly lower than the scores in the MCU ( P = 0.0056 and P < 0.0001 , respectively ) , but NAS during the evening shift did not differ between the ICU and the MCU . The mean NAS for patients admitted to the MCU from the accident and emergency department was significantly higher than for those admitted from the ICU ( P = 0.002 ) , recovery ( P = 0.002 ) , and general ward ( P < 0.0001 ) . Patients on the MCU had a NAS comparable with that of IC \n Output:\n " }, { "from": "agent", "value": "IMCUs often have a specific task in a hospital , which is reflected in location , format , and utilisation .\nCommon IMCU denominators are continuous monitoring and respiratory support , without mechanical ventilation and multiple vasoactive medications" } ]

[ { "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 Falling is a common and morbid condition among elderly persons . Effective strategies to prevent falls have been identified but are underutilized . METHODS Using a nonr and omized design , we compared rates of injuries from falls in a region of Connecticut where clinicians had been exposed to interventions to change clinical practice ( intervention region ) and in a region where clinicians had not been exposed to such interventions ( usual-care region ) . The interventions encouraged primary care clinicians and staff members involved in home care , outpatient rehabilitation , and senior centers to adopt effective risk assessment s and strategies for the prevention of falls ( e.g. , medication reduction and balance and gait training ) . The outcomes were rates of serious fall-related injuries ( hip and other fractures , head injuries , and joint dislocations ) and fall-related use of medical services per 1000 person-years among persons who were 70 years of age or older . The interventions occurred from 2001 to 2004 , and the evaluations took place from 2004 to 2006 . RESULTS Before the interventions , the adjusted rates of serious fall-related injuries ( per 1000 person-years ) were 31.2 in the usual-care region and 31.9 in the intervention region . During the evaluation period , the adjusted rates were 31.4 and 28.6 , respectively ( adjusted rate ratio , 0.91 ; 95 % Bayesian credibility interval , 0.88 to 0.94 ) . Between the preintervention period and the evaluation period , the rate of fall-related use of medical services increased from 68.1 to 83.3 per 1000 person-years in the usual-care region and from 70.7 to 74.2 in the intervention region ( adjusted rate ratio , 0.89 ; 95 % credibility interval , 0.86 to 0.92 ) . The percentages of clinicians who received intervention visits ranged from 62 % ( 131 of 212 primary care offices ) to 100 % ( 26 of 26 home care agencies ) . CONCLUSIONS Dissemination of evidence about fall prevention , coupled with interventions to change clinical practice , may reduce fall-related injuries in elderly persons The aim of this evaluation study was to assess the impact of peer-presented education sessions on the falls-related attitude , knowledge and behaviour of older people . The evaluation was undertaken on the Bellarine Peninsula in Victoria , Australia , and adopted a non-r and omised pre-test post-test design . Baseline , 3 and 12 months follow-up data were collected for 107 individuals who attended the education sessions and 116 controls , matched by age range and sex . The groups were not strictly equivalent at baseline , with the intervention group having a greater knowledge about falls and falls prevention . Analyses which controlled for baseline differences showed that those who attended the education sessions maintained a greater knowledge of factors that can prevent falls at 12 months follow-up . The intervention group also made more changes in and around their home to prevent falls by 3 and 12 months follow-up . Younger participants who reported a previous history of falls and having taken action to prevent falls were most likely to take additional action . The results can help target this type of education program and suggest that their major benefit may lie in providing those who voluntarily attend with the impetus to take the most effective preventative action OBJECTIVES To determine whether a practice -based intervention can improve care for falls , urinary incontinence , and cognitive impairment . DESIGN Controlled trial . SETTING Two community medical groups . PARTICIPANTS Community-dwelling patients ( 357 at intervention sites and 287 at control sites ) aged 75 and older identified as having difficulty with falls , incontinence , or cognitive impairment . INTERVENTION Intervention and control practice s received condition case-finding , but only intervention practice s received a multicomponent practice -change intervention . MEASUREMENTS Percentage of quality indicators satisfied measured using a 13-month medical record abstract ion . RESULTS Before the intervention , the quality of care was the same in intervention and control groups . Screening tripled the number of patients identified as needing care for falls , incontinence , or cognitive impairment . During the intervention , overall care for the three conditions was better in the intervention than the control group ( 41 % , 95 % confidence interval (CI)=35 - 46 % vs 25 % , 95 % CI=20 - 30 % , P<.001 ) . Intervention group patients received better care for falls ( 44 % vs 23 % , P<.001 ) and incontinence ( 37 % vs 22 % , P<.001 ) but not for cognitive impairment ( 44 % vs 41 % , P=.67 ) than control group patients . The intervention was more effective for conditions identified by screening than for conditions identified through usual care . CONCLUSION A practice -based intervention integrated into usual clinical care can improve primary care for falls and urinary incontinence , although even with the intervention , less than half of the recommended care for these conditions was provided . More-intensive interventions , such as embedding intervention components into an electronic medical record , will be needed to adequately improve care for falls and incontinence BACKGROUND Since falling is associated with serious morbidity among elderly people , we investigated whether the risk of falling could be reduced by modifying known risk factors . METHODS We studied 301 men and women living in the community who were at least 70 years of age and who had at least one of the following risk factors for falling : postural hypotension ; use of sedatives ; use of at least four prescription medications ; and impairment in arm or leg strength or range of motion , balance , ability to move safely from bed to chair or to the bathtub or toilet ( transfer skills ) , or gait . These subjects were given either a combination of adjustment in their medications , behavioral instructions , and exercise programs aim ed at modifying their risk factors ( intervention group , 153 subjects ) or usual health care plus social visits ( control group , 148 subjects ) . RESULTS During one year of follow-up , 35 percent of the intervention group fell , as compared with 47 percent of the control group ( P = 0.04 ) . The adjusted incidence-rate ratio for falling in the intervention group as compared with the control group was 0.69 ( 95 percent confidence interval , 0.52 to 0.90 ) . Among the subjects who had a particular risk factor at base line , a smaller percentage of those in the intervention group than of those in the control group still had the risk factor at the time of re assessment , as follows : at least four prescription medications , 63 percent versus 86 percent , P = 0.009 ; balance impairment , 21 percent versus 46 percent , P = 0.001 ; impairment in toilet-transfer skills , 49 percent versus 65 percent , P = 0.05 ; and gait impairment , 45 percent versus 62 percent , P = 0.07 . CONCLUSIONS The multiple-risk-factor intervention strategy result ed in a significant reduction in the risk of falling among elderly persons in the community . In addition , the proportion of persons who had the targeted risk factors for falling was reduced in the intervention group , as compared with the control group . Thus , risk-factor modification may partially explain the reduction in the risk of falling BACKGROUND AND PURPOSE An abundance of evidence suggests that interventions targeting fall risk factors are effective ; however , it remains unknown whether , or to what extent , this body of evidence has affected the clinical practice of physical therapy providers . The purpose s of this study were : ( 1 ) to describe knowledge of , and attitudes toward , fall risk factors and fall reduction strategies ; ( 2 ) to assess self-reported use of fall reduction strategies with patients ; and ( 3 ) to identify factors associated with increased use of fall reduction strategies with patients among physical therapy providers exposed to a behavioral change strategy . SUBJECTS AND METHODS A cross-sectional survey of physical therapy providers from hospital-based and freest and ing outpatient physical therapy facilities throughout north- central Connecticut was conducted between October 2002 and April 2003 . The participants were 94 physical therapy providers who had been exposed to the Connecticut Collaboration for Fall Prevention ( CCFP ) behavioral change effort . The CCFP program uses multicomponent professional behavioral change strategies to embed fall risk factor assessment and management , based on evidence from r and omized controlled trials , into the clinical care of older patients . A telephone question naire -- focusing on fall risk factor knowledge and attitudes and self-reported fall risk factor assessment and management practice s before and after exposure to the CCFP efforts -- was administered to consenting physical therapy providers . RESULTS Environmental hazards and gait and balance deficits were named as fall risk factors by 86 ( 91 % ) and 73 ( 78 % ) participants , respectively . All of the targeted risk factors were mentioned by at least 30 % of the participants . Sixty-four participants ( 68 % ) reported increased fall reduction practice behaviors . The area of multiple medications was noted most frequently , with 77 participants ( 82 % ) noting new practice s related to medication use . Only knowledge of fall risk factors and pre-CCFP behaviors were associated with increased fall reduction practice s. DISCUSSION AND CONCLUSION Physical therapy providers reported an increase in practice behaviors in response to the multicomponent behavioral change strategy . Knowledge of fall risk factors was associated with increased fall reduction practice behaviors , most likely due to the focused nature of the education strategy \n Output:\n " }, { "from": "agent", "value": "The evidence around changing the way people who fall are managed within primary care practice s , and , layperson , peer or community delivered models was mixed .\nIMPACT ON INDUSTRY Translating the evidence -base into practice involves changing the attitudes and behaviours of older people , healthcare professionals and organisations ." } ]

[ { "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 studied 52 adults undergoing elective craniotomy , allocated r and omly to one of three opioid treatments : alfentanil 50 micrograms kg-1 followed by 0.833 microgram kg-1 min-1 until dural closure ( group Alf . ) ; alfentanil 50 micrograms kg-1 followed by 0.833 microgram kg-1 min-1 for 2 h , then remifentanil 0.25 microgram kg-1 min-1 ( group Alf.-Remi . ) ; or remifentanil 1 microgram kg-1 followed by 0.5 microgram kg-1 min-1 reducing to 0.25 microgram kg-1 min-1 after craniotomy ( group Remi . ) . Anaesthesia was maintained with infusion of propofol and 66 % nitrous oxide in oxygen . Infusions of propofol and remifentanil were stopped at head b and aging . Group Remi . had the least intraoperative haemodynamic responses and group Alf . the most ( P < 0.05 ) . Times to tracheal extubation and obey comm and s were similar in all groups . In all patients in group Alf.-Remi . and group Remi . , the trachea was extubated 27 min from the end of anaesthesia ; three patients in group Alf . were slower to recover . Use of analgesia in the recovery room and time to transfer to the neurosurgical unit were similar in the three groups OBJECTIVE Large bolus-dose remifentanil may be advantageous for use during induction of anesthesia because of its short duration of effect . Currently , there are little data on the use of large bolus-dose remifentanil because of reports of severe bradycardia and hypotension . The purpose of this study is to compare the hemodynamic effects of bolus remifentanil versus fentanyl with glycopyrrolate for induction of anesthesia in patients with heart disease . DESIGN A r and omized , double-blinded study . SETTING A tertiary-care academic medical center . PARTICIPANTS One hundred patients for coronary artery bypass or valvular surgery . INTERVENTION Subjects received either ( 1 ) remifentanil , 5 microg/kg , with glycopyrrolate , 0.2 mg , or ( 2 ) fentanyl , 20 microg/kg , with 0.2 mg of glycopyrrolate , and both groups also received midazolam , 70 microg/kg , for induction of anesthesia . MEASUREMENTS AND MAIN RESULTS Heart rate , mean arterial pressure , systemic vascular resistance , and cardiac output were similar between the 2 groups during induction of anesthesia and tracheal intubation . The incidence of adverse events such as bradycardia ( remifentanil 10 % , fentanyl 10 % ) , hypotension ( remifentanil 16 % , fentanyl 10 % ) , and ischemia ( remifentanil 0 % , fentanyl 2 % ) were also similar . A greater percentage of patients in the remifentanil group lost consciousness within 1 minute of opioid administration ( 86 % v 66 % , p = 0.034 ) . CONCLUSION Remifentanil with glycopyrrolate is associated with rapid and predictable clinical anesthetic effect , cardiac stability , and the ability to blunt the hemodynamic responses to tracheal intubation . Bolus remifentanil may be a feasible alternative to bolus fentanyl for induction of anesthesia in patients with heart disease because of its short duration of action and its ability to blunt the hemodynamic responses to tracheal intubation The purpose of this study was to test the hypothesis that using a 1:4 ratio of remifentanil to alfentanil , a remifentanil infusion would provide better suppression of intraoperative responses and comparable recovery profiles after ambulatory laparoscopic surgery than an alfentanil infusion , as part of total intravenous anesthesia . Two hundred ASA physical status I , II , or III adult patients participated in this multicenter , double-blind , parallel group study . Patients were r and omly assigned 2:1 to either the remifentanil-propofol or alfentanil-propofol regimens . The anesthesia sequence was propofol ( 2 mg/kg intravenously [ IV ] followed by 150 micro g [ centered dot ] kg ( -1 ) [ centered dot ] min-1 ) , and either remifentanil ( 1 micro g/kg IV followed by 0.5 micro g [ centered dot ] kg-1 [ centered dot ] min-1 ) or alfentanil ( 20 micro g/kg IV followed by 2 micro g [ centered dot ] kg-1 [ centered dot ] min ( -1 ) ) , and vecuronium . After trocar insertion , infusion rates were decreased ( propofol to 75 micro g [ centered dot ] kg-1 [ centered dot ] min-1 ; remifentanil to 0.25 micro g [ centered dot ] kg-1 [ centered dot ] min-1 ; alfentanil to 1 micro g [ centered dot ] kg-1 [ centered dot ] min-1 ) . Alfentanil and propofol were discontinued at 10 and 5 min , respectively , before the anticipated end of surgery ( last surgical suture ) ; remifentanil was discontinued at the end of surgery . Recovery times were calculated from the end of surgery . The median duration of surgery was similar between groups ( 39 min for remifentanil versus 34 min for alfentanil ) . A smaller proportion of remifentanil patients than alfentanil patients had any intraoperative responses ( 53 % vs 71 % , P = 0.029 ) , had responses to trocar insertion ( 11 % vs 32 % , P < 0.001 ) , or required dosage adjustments during maintenance ( 24 % vs 41 % , P < 0.05 ) . Early awakening times were similar . Remifentanil patients qualified for Phase 1 discharge later and were given postoperative analgesics sooner than alfentanil patients ( P < 0.05 ) . Actual discharge times from the ambulatory center were similar between groups ( 174 min for remifentanil versus 204 min for alfentanil ) ( P = 0.06 ) . In conclusion , remifentanil can be used for maintenance of anesthesia in a 1:4 ratio compared with alfentanil , for total IV anesthesia in ambulatory surgery . This dose of remifentanil provides more effective suppression of intraoperative responses and does not result in prolonged awakening . ( Anesth Analg 1997;84:515 - 21 INTRODUCTION The aim of this study was to investigate how many patients , after anesthesia with either propofol/remifentanil or propofol/fentanyl/alfentanil , within 20 minutes from the end of surgery could be transferred directly to the general ward . The number of undesired preoperative incidents , the anesthetists ' , the surgeons ' , and the patients ' evaluations of the anesthesia were registered . An evaluation of the economic consequences of the two methods was also intended . MATERIAL AND METHODS The study was clinical ly controlled , r and omised , and partly blinded . A total of 80 patients undergoing eye surgery were recruited . The patients were scored 10 , 15 , and 20 minutes after the end of surgery according to a modified Aldrete score . With sufficient awakening score , the patients were transferred to the general ward . RESULTS Thirty-six patients in each group underwent the examination . In the propofol/remifentanil-group 31 ( 86 % ) could be transferred to the general ward compared to 15 ( 42 % ) in the proponol/fentanyl/alfentanil-group . In the propofol/remifentanil-group there were less reactions to the start of surgery , more episodes with preoperative hypotension and postoperative shivering . Otherwise there were no differences between the groups . It was estimated that the additional expenses for medcine were by far outweighed by the lower costs postoperatively . DISCUSSION With a propofol/remifentanil-anesthesia , the patients had a predictably short awakening time , so they could be transferred directly to the general ward . This may , especially in ambulatory surgery , mean cost savings and perhaps higher patient satisfaction We compared a fentanyl/isoflurane/propofol regimen with a remifentanil/isoflurane/propofol regimen for fast-track cardiac anesthesia in a prospect i ve , r and omized , double-blinded study on patients undergoing elective coronary artery bypass graft surgery . Anesthesia was induced with a 1-min infusion of 0.5 mg/kg propofol followed by 10-mg boluses of propofol every 30 s until loss of consciousness . After 0.2 mg/kg cisatracurium , a blinded continuous infusion of remifentanil at 1 & mgr;g · kg−1 · min−1 or the equivalent volume rate of normal saline was then started . In addition , a blinded bolus syringe of 1 & mgr;g/kg remifentanil or 10 & mgr;g/kg fentanyl , respectively , was given over 3 min . Blinded remifentanil , 1 & mgr;g · kg−1 · min−1 ( or the equivalent volume rate of normal saline ) , together with 0.5 % isoflurane , were used to maintain anesthesia . Significantly more patients ( P < 0.01 ) in the fentanyl regimen experienced hypertension during skin incision and maximum sternal spread compared with patients in the remifentanil regimen . There were no differences between the groups in time until extubation , discharge from the surgical intensive care unit , ST segment and other electrocardiogram changes , catecholamine levels , or cardiac enzymes . The remifentanil-based anesthetic ( consisting of a bolus followed by a continuous infusion ) result ed in significantly less response to surgical stimulation and less need for anesthetic interventions compared with the fentanyl regimen ( consisting of an initial bolus , and followed by subsequent boluses only to treat hemodynamic responses ) with both drug regimens allowing early extubation STUDY OBJECTIVES To compare the intraoperative effects and recovery characteristics of remifentanil hydrochloride and alfentanil when administered as part of balanced anesthesia , and to assess the effects of an additional remifentanil infusion administered as analgesic pretreatment before removal of the uterus . DESIGN Multicenter , double-blind , r and omized , parallel-group study . SETTING Two university hospitals . PATIENTS 35 ASA physical status I , II , and III women scheduled for elective total abdominal hysterectomy with general endotracheal anesthesia . INTERVENTIONS Patients were premedicated with midazolam 0.05 mg/kg intravenously ( i.v . ) . Anesthesia was induced with thiopental 2 mg/kg , vecuronium 0.15 mg/kg , and a single dose of opioid over 60 seconds ( Pump 1 ) : remifentanil 2 micrograms/kg ( Remi/Placebo and Remi/Remi groups ) or alfentanil 50 micrograms/kg ( Alf/Placebo group ) . Anesthesia was maintained with a nitrous oxide/oxygen mixture ( 66:34 ratio ) and a continuous opioid infusion : remifentanil 0.25 microgram/kg/min ( Remi/Placebo and Remi/Remi ) or alfentanil 0.5 microgram/kg/min ( Alf/Placebo ) . At skin incision , a second blinded drug infusion was also initiated ( Pump 2 ) : remifentanil 0.25 microgram/kg/min ( Remi/Remi ) or saline placebo ( Remi/Placebo and Alf/Placebo ) . Intraoperative responses were controlled with single doses of opioid and /or rate titrations via Pump 1 . Pump 2 was terminated on removal of the uterus . Pump 1 was terminated at skin closure . MEASUREMENTS AND MAIN RESULTS The mean ( + /- SD ) opioid infusion rates administered for the duration of Pump 2 to suppress responses to removal of the uterus were 0.49 + /- 0.27 microgram/kg/min , 1.99 + /- 1.34 micrograms/kg/min , and 0.49 + /- 0.07 microgram/kg/min for the Remi/Placebo , Alf/Placebo , and Remi/Remi groups , respectively . At these rates , similar proportions of patients in the Remi/Placebo ( 67 % ) and the Alf/Placebo ( 60 % ) groups had responses . Fewer patients had responses in the Remi/Remi group ( 8 % ) compared with the Remi/Placebo and Alf/Placebo groups ( p < 0.05 ) . The mean total opioid doses used during maintenance were 84.6 micrograms/kg ( Remi/Placebo ) , 393 micrograms/kg ( Alf/Placebo ) , and 68.7 micrograms/kg ( Remi/Remi ) . Awakening times were significantly shorter ( p < 0.05 ) in the remifentanil population compared with the alfentanil population , but discharge times were similar . More patients received naloxone to reverse opioid effects in the alfentanil population ( 60 % ) than in the remifentanil population ( 20 % ) ( p < 0.0 \n Output:\n " }, { "from": "agent", "value": "Remifentanil does not seem to offer any advantage for lengthy , major interventions , but may be useful for selected patients , e.g. when postoperative respiratory depression is a concern" } ]

[ { "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 VEGFR-2 has a role in gastric cancer pathogenesis and progression . We assessed whether ramucirumab , a monoclonal antibody VEGFR-2 antagonist , in combination with paclitaxel would increase overall survival in patients previously treated for advanced gastric cancer compared with placebo plus paclitaxel . METHODS This r and omised , placebo-controlled , double-blind , phase 3 trial was done at 170 centres in 27 countries in North and South America , Europe , Asia , and Australia . Patients aged 18 years or older with advanced gastric or gastro-oesophageal junction adenocarcinoma and disease progression on or within 4 months after first-line chemotherapy ( platinum plus fluoropyrimidine with or without an anthracycline ) were r and omly assigned with a central ised interactive voice or web-response system in a 1:1 ratio to receive ramucirumab 8 mg/kg or placebo intravenously on days 1 and 15 , plus paclitaxel 80 mg/m(2 ) intravenously on days 1 , 8 , and 15 of a 28-day cycle . A permuted block r and omisation , stratified by geographic region , time to progression on first-line therapy , and disease measurability , was used . The primary endpoint was overall survival . Efficacy analysis was by intention to treat , and safety analysis included all patients who received at least one treatment with study drug . This trial is registered with Clinical Trials.gov , number NCT01170663 , and has been completed ; patients who are still receiving treatment are in the extension phase . FINDINGS Between Dec 23 , 2010 , and Sept 23 , 2012 , 665 patients were r and omly assigned to treatment-330 to ramucirumab plus paclitaxel and 335 to placebo plus paclitaxel . Overall survival was significantly longer in the ramucirumab plus paclitaxel group than in the placebo plus paclitaxel group ( median 9·6 months [ 95 % CI 8·5 - 10·8 ] vs 7·4 months [ 95 % CI 6·3 - 8·4 ] , hazard ratio 0·807 [ 95 % CI 0·678 - 0·962 ] ; p=0·017 ) . Grade 3 or higher adverse events that occurred in more than 5 % of patients in the ramucirumab plus paclitaxel group versus placebo plus paclitaxel included neutropenia ( 133 [ 41 % ] of 327 vs 62 [ 19 % ] of 329 ) , leucopenia ( 57 [ 17 % ] vs 22 [ 7 % ] ) , hypertension ( 46 [ 14 % ] vs eight [ 2 % ] ) , fatigue ( 39 [ 12 % ] vs 18 [ 5 % ] ) , anaemia ( 30 [ 9 % ] vs 34 [ 10 % ] ) , and abdominal pain ( 20 [ 6 % ] vs 11 [ 3 % ] ) . The incidence of grade 3 or higher febrile neutropenia was low in both groups ( ten [ 3 % ] vs eight [ 2 % ] ) . INTERPRETATION The combination of ramucirumab with paclitaxel significantly increases overall survival compared with placebo plus paclitaxel , and could be regarded as a new st and ard second-line treatment for patients with advanced gastric cancer . FUNDING Eli Lilly and Company Background Treatment of patients with advanced or metastatic esophagogastric adenocarcinoma should not only prolong life but also provide relief of symptoms and improve quality of life ( QOL ) . Esophagogastric adenocarcinoma mainly occurs in elderly patients , but they are underrepresented in most clinical trials and often do not receive effective combination chemotherapy , most probably for fear of intolerance . Using vali date d instruments , we prospect ively assessed QOL within the r and omized FLOT65 + phase II trial . Methods Within the FLOT65 + trial , a total of 143 patients aged ≥65 years were r and omly allocated to receive biweekly oxaliplatin plus 5-fluorouracil ( 5-FU ) continuous infusion and folinic acid ( FLO ) or the same regimen in combination with docetaxel 50 mg/m2 ( FLOT ) . The European Organisation for Research and Treatment of Cancer Quality of Life Question naire C30 ( EORTC QLQ-C30 ) and the gastric module STO22 were administered every 8 weeks until progression . Time to definitive deterioration of QOL parameters was analyzed and compared within the treatment arms . Results The median age of patients was 70 years . Patients receiving FLOT exhibited higher response rates and had improved disease-free and progression-free survival ( PFS ) . The proportions of patients with evaluable baseline EORTC QLQ-C30 and STO22 question naires were balanced ( 83 % in FLOT and 89 % in FLO ) . Considering evaluable patients with assessable question naires ( n = 123 ) , neither functioning nor symptom parameters differed significantly in favor of one of the two treatment groups . Particularly , there was no significant difference regarding time to definitive deterioration of global health status/ quality of life from baseline ( primary endpoint ) . Notably , patients receiving FLO or FLOT as palliative treatment ( n = 98 ) achieved comparable QOL results . Conclusions Although toxicity was higher in patients receiving FLOT , no negative impact of the addition of docetaxel on QOL parameters could be demonstrated . Thus , elderly patients in need of intensified chemotherapy may receive FLOT without compromising patient-reported outcome parameters BACKGROUND This r and omised study compared protracted venous infusion ( PVI ) fluorouracil ( 5-FU ) with PVI 5-FU plus mitomycin C ( MMC ) in patients with advanced oesophago-gastric cancer . PATIENTS AND METHODS Two hundred and fifty-four patients with adenocarcinoma , squamous cell carcinoma or undifferentiated carcinoma involving the oesophagus , oesophago-gastric junction or the stomach were r and omised . The major end points were tumour response , survival , toxicity and quality of life . RESULTS The median age of patients treated was 72 years and the two arms were well-balanced for baseline demographic factors . The overall response rate was 16.1 % [ 95 % confidence interval ( CI ) 9.5 % to 22.7 % ] in patients treated with PVI 5-FU alone compared with 19.1 % ( 95 % CI 12.0 % to 26.0 % ) for those treated with PVI 5-FU plus MMC ( P = 0.555 ) . Median time to treatment failure was 3.9 months for PVI 5-FU and 3.8 months for PVI 5-FU plus MMC ( P = 0.195 ) . Median survival was 6.3 months for PVI 5-FU and 5.3 months for PVI 5-FU plus MMC ( P = 1.0 ) . Toxicity was mild for both treatments . Symptomatic benefit measured by improvement in pain control , weight loss , dysphagia and oesophageal reflux was observed in over 64 % of patients in each arm . Quality of life scores were comparable in each arm . CONCLUSIONS PVI 5-FU is a safe , effective form of palliation for patients with advanced oesophago-gastric cancer although the addition of MMC adds little extra benefit We report the final results of a prospect ively r and omized study that compared the combination of epirubicin , cisplatin and protracted venous infusion fluorouracil ( 5-FU ) ( ECF regimen ) with the st and ard combination of 5-FU , doxorubicin and methotrexate ( FAMTX ) in previously untreated patients with advanced oesophagogastric cancer . Between 1992 and 1995 , 274 patients with adenocarcinoma or undifferentiated carcinoma were r and omized from eight oncology centres in the UK and analysed for response and survival . The overall response rate was 46 % ( 95 % confidence interval ( CI ) , 37–55 % ) with ECF , and 21 % ( 95 % CI , 13–28 % ) with FAMTX ( P = 0.00003 ) . The median survival was 8.7 months with ECF and 6.1 months with FAMTX ( P = 0.0005 ) . The 2-year survival rates were 14 % ( 95 % CI , 8–20 % ) for the ECF arm , and 5 % ( 95 % CI , 2–10 % ) for the FAMTX arm ( P = 0.03 ) . Histologically complete surgical resection following chemotherapy was achieved in ten patients in the ECF arm ( three pathological complete responses to chemotherapy ) and three patients in the FAMTX arm ( no pathological complete responses ) . The ECF regimen result ed in a response and survival advantage compared with FAMTX chemotherapy . The probability of long-term survival following surgical resection of residual disease is increased by this treatment . The high response rates seen with ECF support its use in the neoadjuvant setting BACKGROUND Irinotecan , in combination with 5-fluorouracil ( 5-FU ) or cisplatin , has demonstrated efficacy against advanced gastric cancer ( AGC ) . PATIENTS AND METHODS Chemotherapy-naive AGC patients were r and omly assigned to receive irinotecan 150 mg/m(2 ) on day 1 , leucovorin 20 mg/m(2 ) and a 22-h infusion of 5-FU 1000 mg/m(2 ) on days 1 and 2 ( ILF ) or ILF plus cisplatin 30 mg/m(2 ) on day 2 ( PILF ) . Treatment was repeated every 2 weeks . RESULTS Of 91 registered patients , 45 patients were treated with ILF and 45 with PILF . For both arms , 687 chemotherapy cycles were delivered ( median = 7 for ILF and 8 for PILF ) . Both ILF and PILF were generally well tolerated and there was no relevant difference in the occurrence of overall grade 3/4 toxic effects between the two arms . Four patients died during treatment : one in the ILF and three in the PILF arm . The objective response rate was 42 % for both arms . There was no significant difference in therapeutic efficacy between ILF and PILF with respect to progression-free survival ( 4.8 versus 6.2 months ; P = 0.523 ) and overall survival ( 10.7 versus 10.5 months ; P = 0.850 ) . CONCLUSION Both ILF and PILF are active as first-line chemotherapy for AGC . The addition of cisplatin , however , has no clear advantage over ILF BACKGROUND We aim ed to establish the superiority ( or noninferiority if superiority was not achieved ) in terms of time to progression ( TTP ) of irinotecan/5-fluorouracil ( IF ) over cisplatin/5-fluorouracil ( CF ) in chemonaive patients with adenocarcinoma of the stomach/esophagogastric junction . PATIENTS AND METHODS Patients received either IF : i.v . irinotecan 80 mg/m(2 ) 30 min , folinic acid 500 mg/m(2 ) 2 h , 5-fluorouracil ( 5-FU ) 2000 mg/m(2 ) 22 h , for 6/7 weeks or CF : cisplatin 100 mg/m(2 ) 1 - 3 h , with 5-FU 1000 mg/m(2)/day 24 h , days 1 - 5 , every 4 weeks . RESULTS In all , 333 patients were r and omized and treated ( IF 170 , CF 163 ) . Patient characteristics were balanced except more IF patients had Karnofsky performance status 100 % . TTP for IF was 5.0 months [ 95 % confidence interval ( CI ) 3.8 - 5.8 ] and 4.2 months ( 95 % CI 3.7 - 5.5 ) for CF ( P = 0.088 ) . Overall survival ( OS ) was 9.0 versus 8.7 months , response rate 31.8 % versus 25.8 % , time to treatment failure ( TTF ) 4.0 versus 3.4 months for IF and CF , respectively . The difference in TTF was statistically significant ( P = 0.018 ) . IF was better in terms of toxic deaths ( 0.6 % versus 3 % ) , discontinuation for toxicity ( 10.0 % versus 21.5 % ) , severe neutropenia , thrombocytopenia and stomatitis , but not diarrhea . CONCLUSION IF did not yield a significant TTP or OS superiority over CF , and the results of noninferiority of IF were borderline . However , IF may provide a viable , platinum-free front-line treatment alternative for metastatic gastric cancer OBJECTIVES More than half of cases of gastric cancer ( GC ) are diagnosed in elderly patients ( ≥70years ) . While doublet combination with fluoropyrimidines and platinum is currently considered st and ard first-line chemotherapy in advanced GC , the main goal of chemotherapy remains palliation . MATERIAL S \n Output:\n " }, { "from": "agent", "value": "HRQoL reporting did not improve over time , and it did not improve following the publication of the CONSORT-PRO statement in 2013 .\nThe publication of HRQoL findings in a separate article and second-line treatment were associated with better reporting .\nConclusions HRQoL reporting in RCTs concerning palliative systemic therapy for advanced esophagogastric cancer is limited and has not improved 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: Objectives This study aims to evaluate the efficacy of methadone as substitute for morphine and to investigate if the addition of acetaminophen could reduce the time to attain an equianalgesic dose of methadone and /or to improve the level of pain control in oncologic patients . Patients and methods Fifty patients on stable doses of morphine for 1 week were switched to methadone using a “ stop – start ” strategy and r and omized in a double-blind fashion to receive either acetaminophen ( 750 mg PO every 6 hours ) or placebo for a 7-day period . We collected data regarding level of pain , side effects , and quality of life . Results Substitution of morphine for methadone result ed in a significant reduction in constipation ( p < 0.001 ) and xerostomia ( p = 0.03 ) . There was also an improvement in the numeric pain scale ( p = 0.03 ) as well as a significant improvement in the functional level and symptomatology according to the QLQ-C30 question naire . Addition of acetaminophen did not improve pain control or reduce the time of stabilization of analgesia once methadone was introduced . At the end of the study , most patients ( 70.8 % , p = 0.001 ) preferred methadone to morphine . Conclusions Early switching from morphine to methadone was a safe and efficient strategy for the reduction of side effects and improvement of analgesia , allowing for a comfortable dosing regimen . In this scenario , the association with acetaminophen did not improve pain control or reduce the time to achieve an equianalgesic dose of methadone AIM Opioid switching is a treatment strategy in cancer patients with unacceptable pain and /or adverse effects ( AEs ) . We investigated whether patients switched to methadone by the stop and go ( SAG ) strategy have lower pain intensity ( PI ) than the patients switched over three days ( 3DS ) , and whether the SAG strategy is as safe as the 3DS strategy . METHODS In this prospect i ve , open , parallel-group , multicentre study , 42 cancer patients on morphine or oxycodone were r and omised to the SAG or 3DS switching- strategy to methadone . The methadone dose was calculated using a dose-dependent ratio . PI , AEs and serious adverse events ( SAEs ) were recorded daily for 14 days . Primary outcome was average PI day 3 . Secondary outcomes were PI now and AEs day 3 and 14 and number of SAEs . RESULTS Twenty one patients were r and omised to each group , 16 ( SAG ) and 19 ( 3DS ) patients received methadone . The mean preswitch morphine doses were 900 mg/day in SAG and 1330 mg/day in 3DS . No differences between groups were found in mean average PI day 3 ( mean difference 0.5 ( CI -1.2 - 2.2 ) ; SAG 4.1 ( CI 2.3 - 5.9 ) and 3DS 3.6 ( CI 2.9 - 4.3 ) or in PI now . The SAG group had more dropouts and three SAEs ( two deaths and one severe sedation ) . No SAEs were observed in the 3DS group . CONCLUSION The SAG patients reported a trend of more pain , had significantly more dropouts and three SAEs , which indicate that the SAG strategy should not replace the 3DS when switching from high doses of morphine or oxycodone to methadone Background : This study was design ed to evaluate the role of epidural methadone-lidocaine in cancer pain combined or not to epidural dexamethasone . Methods : In all , 72 cancer patients , 32- to 67-year-old were r and omized to six groups ( n=12 ) and prospect ively studied to examine analgesia and adverse effects for 3 weeks . Patients received single-dose protocol epidural test drugs : Control group ( CG ) received epidural 40-mg lidocaine diluted to 10-ml volume with saline . Dexamethasone group ( DG ) 40-mg lidocaine plus 10-mg dexamethasone . The 2.5MetG 2.5-mg epidural methadone with 40-mg lidocaine ; the 5MetG , 5-mg epidural methadone plus 40-mg lidocaine , the 7.5MetG , 7.5-mg epidural methadone plus 40-mg lidocaine and finally the 7.5Met-DexG , 7.5-mg methadone with 40-mg lidocaine and 10-mg dexamethasone . Results : Groups CG , DG and 2.5MetG were similar regarding analgesia and side effects . Patients from 5MetG and 7.5MetG took 3±1 and 5±1 days , respectively , to restart oral morphine . Patients from 7.5MetDG took 14±2 to restart oral morphine ( P<0.001 ) . Daily somnolence and appetite improved in the 7.5MetDG during 2-week evaluation ( P<0.005 ) . Fatigue improved for both DG and 7.5MetDG during 2-week evaluation ( P<0.005 ) . By the third week of evaluation , all patients were similar . Conclusions : Epidural methadone plus lidocaine result ed in dose-dependent analgesia , further improved by epidural dexamethasone , which also improved fatigue PURPOSE To compare the effectiveness and side effects of methadone and morphine as first-line treatment with opioids for cancer pain . PATIENTS AND METHODS Patients in international palliative care clinics with pain requiring initiation of strong opioids were r and omly assigned to receive methadone ( 7.5 mg orally every 12 hours and 5 mg every 4 hours as needed ) or morphine ( 15 mg sustained release every 12 hours and 5 mg every 4 hours as needed ) . The study duration was 4 weeks . RESULTS A total of 103 patients were r and omly assigned to treatment ( 49 in the methadone group and 54 in the morphine group ) . The groups had similar baseline scores for pain , sedation , nausea , confusion , and constipation . Patients receiving methadone had more opioid-related drop-outs ( 11 of 49 ; 22 % ) than those receiving morphine ( three of 54 ; 6 % ; P = .019 ) . The opioid escalation index at days 14 and 28 was similar between the two groups . More than three fourths of patients in each group reported a 20 % or more reduction in pain intensity by day 8 . The proportion of patients with a 20 % or more improvement in pain at 4 weeks in the methadone group was 0.49 ( 95 % CI , 0.34 to 0.64 ) and was similar in the morphine group ( 0.56 ; 95 % CI , 0.41 to 0.70 ) . The rates of patient-reported global benefit were nearly identical to the pain response rates and did not differ between the treatment groups . CONCLUSION Methadone did not produce superior analgesic efficiency or overall tolerability at 4 weeks compared with morphine as a first-line strong opioid for the treatment of cancer pain OBJECTIVES Neuropathic cancer pain ( NCP ) is a common manifestation of cancer and /or its treatment . Treatment following the WHO analgesic ladder provides relief for the majority of cancer pain patients ; however , concern remains that opioids may be less efficacious for neuropathic pain ( NP ) compared with nociceptive pain , often necessitating the use of higher doses . Adjuvants , such as pregabalin , have shown to be efficacious for the treatment of NP , although data come mostly from noncancer studies . The comparative efficacy and safety of opioids versus adjuvants has not been studied for NCP . The aim of this study was to directly compare pregabalin versus a strong opioid for the treatment of NCP . METHODS A total of 120 patients , diagnosed with \" definite \" NCP , were r and omized into two groups and received increasing doses of either oral pregabalin or transdermal fentanyl for 28 days . VAS score , patient satisfaction , need for opioid rescue , and adverse events ( AEs ) were recorded . RESULTS In the pregabalin group , a significantly higher proportion of patients achieved at least 30 % reduction in VAS compared with the fentanyl group ( 73.3 % , 95 % CI : 60.3%-83.93 vs. 36.7 % , 95 % CI : 24.5%-50.1 % , P < 0.0001 , respectively ) , while the percentage mean change from baseline was also significantly different [ 46 % ( 95 % CI : 39.5%-52.8 % ) for pregabalin and 22 % ( 95 % CI : 14.9%-29.5 % ) for fentanyl ( P < 0.0001 ) ] . Patient-reported satisfaction was more frequent with pregabalin , while AEs and treatment discontinuations were more frequent in the fentanyl group . DISCUSSION Prompt use of a neuropathic pain-specific adjuvant , such as pregabalin , in NCP may lead to better control of the neuropathic component , with opioid-sparing effects Eighteen patients suffering from cancer were entered into a study of the pharmacokinetics and efficacy of methadone and morphine in pain control . All patients had both clinical and radiological evidence of metastatic spread of their cancer and there were no significant differences in age , weight and sites of the primary cancer between the methadone ( n = 9 ) and morphine ( n = 9 ) groups . Blood opioid concentration , visual analogue pain scores ( VAPS ) and end-tidal percent carbon dioxide were measured before and after both an intravenous and oral dose of either methadone or morphine . Terminal half-lives ( mean + /- S.D. ) were 30.4 + /- 16.3 h and 2.7 + /- 1.2 h respectively for methadone and morphine while the clearance values ( mean + /- S.D. ) were 0.19 + /- 0.13 l/min and 1.16 + /- 0.47 l/min . The long half-life of methadone was associated with prolonged pain relief . However , the large variation in the half-life of methadone necessitated careful adjustment of the dosing interval in individual patients . There were pronounced differences in oral bioavailability between the two opioids : methadone , 79 + /- 11.7 % , compared to morphine , 26 + /- 13 % ( mean + /- S.D. ) . Of greater clinical significance was the variability in these bioavailability estimates with a coefficient of variation of 15 % for methadone compared to 50 % for morphine . The combined effects of low and variable oral bioavailability for morphine may result in sub-therapeutic doses being administered as practitioners may be inhibited by the size of the effective oral morphine dose and may be confused by the variability in this dose compared to intramuscular doses . The initial oral dose of morphine varied from 15 mg 4 hourly to 150 mg 3 hourly , while the initial dose for methadone varied from 15 mg on alternate nights to 20 mg twice daily . There was no rapid escalation of daily opioid dose for either methadone or morphine when adequate pain control was provided rapidly at the start of treatment by the technique described in this study PURPOSE The aim of this study was to compare the analgesic and adverse effects , doses , as well as cost of opioid drugs , supportive drug therapy and other analgesic drugs in patients treated with oral sustained-release morphine , transdermal fentanyl , and oral methadone . PATIENTS AND METHODS One hundred and eight cancer patients , no longer responsive to opioids for moderate pain , were selected to r and omly receive initial daily doses of 60 mg of oral sustained-release morphine , 15 mg of oral methadone , or 0.6 mg ( 25 microg/h ) of transdermal fentanyl . Oral morphine was used as breakthrough pain medication during opioid titration . Opioid doses , pain intensity , adverse effects , symptomatic drugs , were recorded at week intervals for 4 weeks . Costs of opioid therapy , supportive drugs , and other analgesic drugs were also evaluated . RESULTS Seventy patients completed the 4 weeks period of study . Five , five , and four patients , treated with oral morphine , transdermal fentanyl , and oral methadone , respectively , required opioid switching . No differences in pain and symptom intensity were observed . Opioid escalation index was significantly lower in patients receiving methadone ( p<0.0001 ) , although requiring up and down changes in doses . At the doses used , methadone was significantly less expensive ( p<0.0001 ) , while the use and costs of supportive drugs and other analgesics were similar in the three groups . No relevant differences in adverse effects were observed among the groups during either the titration phase and chronic treatment . CONCLUSION All the three opioids used as first-line therapy were effective , well tolerated , and required similar amounts of symptomatic drugs or co-analgesics . Methadone was significantly less expensive , but required more changes , up and down , of the doses , suggesting that dose titration of this drug requires major clinical expertise The analgesic effectiveness and adverse effect incidence of a daily \n Output:\n " }, { "from": "agent", "value": "None of the studies reported effects on appetite .\nBased on low- quality evidence , methadone is a drug that has similar analgesic benefits to morphine and has a role in the management of cancer pain in adults .\nOther opioids such as morphine and fentanyl are easier to manage but may be more expensive than methadone in many economies" } ]

[ { "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 and compare levels of patient discomfort and perioperative complications during phacoemulsification and implantation of a foldable intraocular lens under topical lidocaine hydrochloride and retrobulbar anesthesia in patients with cataract who also had exfoliation syndrome , uveitis , posterior synechia , phacodonesis , or previous intraocular surgery . DESIGN A prospect i ve , r and omized , controlled trial was carried out at 2 institutions . PARTICIPANTS A total of 476 eyes of 476 patients with various well-established risk factors fulfilled the inclusion criteria . In 238 eyes , phacoemulsification was performed under retrobulbar anesthesia , while the other 238 eyes received topical anesthesia . INTERVENTIONS All patients underwent temporal clear corneal phacoemulsification and implantation of a foldable intraocular lens . Patients under retrobulbar anesthesia received a single injection ( 3 . 5 - 5.5 mL ) of a combination of 0.75 % bupivacaine hydrochloride , 2 % lidocaine , and hyaluronidase into the retrobulbar space . Patients in the topical anesthesia group received a minimum of 5 doses ( approximately 40 microL per dose ) of 2 % topical lidocaine . No intracameral injection of any anesthetic was given . MAIN OUTCOME MEASURES The number of complications and adverse events . The intraoperative conditions were judged by the surgeon ( P.C.J. or F.K. J. ) , and a 10-point visual analog scale was used immediately after surgery to assess each patient 's overall severity of intraoperative pain . RESULTS The overall intraoperative complication rate was 1.9 % for capsular tear , 3.8 % for zonular tear , 1.5 % for vitreous loss , and 1.0 % for iris prolapse . Apart from the incidence of vitreous loss , which was significantly ( P = .041 ) lower in the topical anesthesia group , no statistically significant differences in intraoperative and early postoperative complications were found between the groups . A supplemental posterior sub-Tenon space injection was required in 1.3 % of the topical anesthesia group and in 0.8 % of the retrobulbar anesthesia group . Chemosis ( 2.5 % ) , subconjunctival hemorrhage ( 1.7 % ) , and periorbital hematoma ( 0.8 % ) were seen only in the retrobulbar anesthesia group . The mean + SE pain scores estimated by the patients were 0.84 + 1.30 in the topical anesthesia group and 0.73 + 1.50 in the retrobulbar anesthesia group ( P = .41 ) . Patient preference for topical anesthesia ( 91 % ) appeared to be significantly ( P = .01 ) higher than for retrobulbar anesthesia ( 62 % ) . The surgeons found anesthesia-related intraoperative difficulty to be slightly lower in the retrobulbar anesthesia group ( 8 % ) than in the topical anesthesia group ( 14 % ) . CONCLUSIONS Surgery-related complications and patient discomfort were similar for the 2 methods of anesthesia . Topical anesthesia is justified as a means of improving safety without causing discomfort to the patient even in complicated cases of cataract surgery . Arch Ophthalmol . 2000;118:1037 - AIMS The effect of local anaesthetics on optic nerve function can be investigated by quantifying the relative afferent pupillary defect ( RAPD ) . METHODS The study compared the depth of induced RAPD following posterior sub-Tenon 's , retrobulbar , and peribulbar local anaesthetics using crossed polarising filters before cataract surgery ( time 1 = 5 minutes ) , immediately after surgery ( time 2 = 42 minutes ( av ) ) , and once again on the ward ( time 3 = 107 minutes ( av ) ) . RESULTS All patients developed a RAPD . There was no significant difference in the depth of RAPD between the groups at any one time period . The peribulbar group had a significantly steeper decay in RAPD from time 1 to time 2 ( p = 0.014 ) . This effect was reduced when the shorter operation time for this group was entered as a cofactor ( p = 0.063 ) . By time 3 the RAPDs for all groups had decayed similarly so that no differences could be detected . CONCLUSION All three anaesthetic methods caused a similar level of disruption to optic nerve conduction immediately following administration and at the time of day case discharge BACKGROUND AND OBJECTIVE To evaluate the response of intraocular pressure ( IOP ) to retrobulbar and peribulbar anesthesia . PATIENTS AND METHODS Patients were prospect ively masked and r and omized to receive either 4 cc of retrobulbar anesthesia ( X = 29 ) or 6 cc of peribulbar anesthesia ( X = 30 ) , each consisting of a 50:50 mixture of 2 % xylocaine and 0.75 % bupivacaine with 150 units of hyaluronidase . IOPs were measured pre-anesthesia and 1 , 2 , and 5 minutes post-anesthesia in nonglaucoma patients undergoing cataract extraction and intraocular lens implantation . RESULTS Mean IOPs in the retrobulbar group as determined with a tonometer were 18.24 , 18.66 , 19.14 , and 17.86 mm Hg pre-anesthesia and 1 , 2 , and 5 minutes post-anesthesia , respectively . In the peribulbar group , the mean IOPs were 18.53 , 21.20 , 20.40 , and 19.20 mm Hg , respectively . The 1-minute pressures in the two groups were statistically different ( P = .023 ) . Within the peribulbar group , the 1- and 2-minute pressures were statistically different from the pre-anesthesia IOP ( P = .001 and P = .018 , respectively ) . CONCLUSION Peribulbar anesthesia , with its higher volume of anesthetic ( 6 vs 4 cc ) , results in a higher initial IOP . This difference was slight and short lived , and occurred in the absence of any external ocular compression . This study may have application in avoiding elevation of IOP in select patients undergoing a local procedure ABSTRACT One hundred patients having elective cataract surgery were evaluated in a prospect i ve , r and omized , double‐blinded study comparing retrobulbar and peribulbar anesthesia . Patients were divided into two study groups and evaluated on three criteria felt to be critical to intraocular surgery . Results showed that the efficacy of the oneinjection‐site peribulbar block was similar to that of the retrobulbar block for all three criteria . Because the one‐injection‐site anesthetic is administered outside the muscle cone , the potential for optic nerve and central nervous system complications should be minimized Abstract Although usually safe , retrobulbar anesthesia and peribulbar anesthesia have potentially sight‐ and life‐threatening complications . Although it has been suggested that peribulbar anesthesia is as effective and safer than retrobulbar anesthesia , no large study has addressed the true rate of complications . To determine the efficacy and safety of peribulbar anesthesia , this study prospect ively examined 16,224 consecutive peribulbar blocks . Twelve centers in the United States , Germany , and Chile participated in the study . After a peribulbar block was administered , the degree of akinesia , amaurosis , percentage of supplemental blocks required , and side effects and complications occurring after the block and for six weeks were recorded . Perioperative and late optic nerve complications were included . To approximate a real‐life situation , ophthalmologists , anesthesiologists , and certified registered nurse anesthetists performed the blocks . Ninety‐five percent of patients achieved a 95 % or greater degree of akinesia . The incidence of complications in the consecutive cases was low . Orbital hemorrhage occurred in 12 cases ( 0.74 % ) . There was one globe perforation ( 0.006 % ) , two expulsive hemorrhages ( 0.013 % ) , one gr and mal seizure ( 0.006 % ) , and no cases of cardiac or respiratory depression or deaths . Peribulbar is as effective as retrobulbar anesthesia and appears to lead to fewer sight‐ and life‐threatening complications , even when slightly different peribulbar techniques are used . This is especially true when the anesthetic is administered with a 1 1/4‐inch or shorter needle with the eye in the primary position , followed by ten to 15 minutes of ocular compression Complications of retrobulbar anesthesia are rare but significant . Periocular anesthesia has been advocated as an alternative to retrobulbar injections . In a prospect i ve , r and omized , masked study of 79 consecutive cataract extraction s with intraocular lens implantations , 40 patients received retrobulbar injections and 39 patients received periocular injections . In every instance , the volume of the injection was 5 mL. No significant difference in surgeon 's assessment of akinesia and anesthesia was found . Supplemental anesthesia was required in eight ( 21 % ) of the patients who received retrobulbar injections and in 11 ( 28 % ) of the patients who received periocular injections . A significant increase in chemosis was found with periocular injections . There was one complication with retrobulbar anesthesia and none with periocular anesthesia . No significant difference in patient assessment of comfort was found . The efficacy of periocular anesthesia appears to be comparable to that of retrobulbar anesthesia Two methods of periocular anaesthesia ( PI and PII ) were compared with the traditional retrobulbar block in a prospect i ve study of 450 patients undergoing elective cataract extraction and intraocular lens implantation . A solution of local anaesthetic containing equal amounts of 2 % lignocaine and 0.5 % bupivacaine was used in all the groups . Hyaluronidase ( 75 IU/10 ml of local anaesthetic solution ) was added . Three groups of patients were studied , with 150 patients in each group . The retrobulbar injection ( group R ) was performed with 4 ml of the anaesthetic solution through the lower eyelid inferotemporally and a further 6 ml was injected for seventh cranial nerve block . In the first periocular technique ( group PI ) the local anaesthetic was injected inferotemporally ( 5 ml ) through the lower lid and superonasally ( 5 ml ) through the upper lid . In the second periocular technique ( PII ) the injections were performed inferotemporally ( 5 ml ) and into the medial compartment ( 2 ml ) of the orbit at the medial canthus . Satisfactory anaesthesia could be achieved with all of these methods . Additional block because of insufficient akinesia of the muscles was required in 12 % ( 18/150 ) in group R , in 19 % ( 28/150 ) in group PI , and in 11 % ( 16/150 ) in PII . The medial compartment technique ( PII ) was associated with the highest percentage of total akinesia of the muscles and lowest reblock rate . All three methods produced sufficient analgesia during surgery and there were no differences in the requirements for additional analgesic drugs during surgery . It is concluded that the medial compartment technique represents a good alternative to retrobulbar block A prospect i ve trial was conducted on 142 patients who underwent cataract surgery , to compare the efficacy of a single point , low volume peribulbar with that of retrobulbar anaesthesia . It was found that peribulbar anaesthesia is as efficacious as retrobulbar anaesthesia without the associated complications . It also avoids the facial block used by most ophthalmologists to supplement a retrobulbar block , thus markedly reducing the post-operative patient discomfort as well as the total volume of anaesthetic used Purpose : To assess the effects of retrobulbar and peribulbar anesthesia on nerve function as detected by visual‐evoked potentials ( VEPs ) . Setting : University hospital in southern Brazil . Methods : In a prospect i ve study , 7 patients had peribulbar anesthesia and 9 had retrobulbar anesthesia for extracapsular cataract extraction . Visual‐evoked potentials with pattern reversal and flash stimulation were performed at least 1 month before and 1 month after surgery . Study participants did not have ocular pathology other than cataract . The Lens Classification System III was used to grade the opacities before surgery . Results : No significant difference was found between preoperative and postoperative evaluations in VEP flash and pattern‐reversal amplitude and latency in either group ( P > .05 ) . Postoperative amplitude and latency was not significantly different between the peribulbar and retrobulbar groups . Two cases in the peribulbar group had altered wave morphology without clinical manifestation postoperatively . All patients had a final best spectacle‐corrected visual acuity of 20/20 . Conclusion : Block anesthetic procedures were safely used in cataract surgery , with no clinical sequelae to the optic nerve Peribulbar anaesthesia is now established as an alternative to retrobulbar anaesthesia for cataract surgery . However , the larger volume of anaesthetic solution in the extraconal \n Output:\n " }, { "from": "agent", "value": "Three of the six trials had adequate sequence generation while all the trials had unclear allocation concealment There was no evidence of any difference in pain perception during surgery with either retrobulbar or peribulbar anaesthesia .\nBoth were largely effective .\nThere was no evidence of any difference in complete akinesia or the need for further injections of local anaesthetic .\nThere is little to choose between peribulbar and retrobulbar block in terms of anaesthesia and akinesia during surgery measuring acceptability to patients , need for additional injections and development of severe complications .\nSevere local or systemic complications were rare for both types of block" } ]

[ { "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: Although the incidence of carotid atheromatous disease is presumably equal between the right and left carotid arteries , right and left carotid endarterectomies ( CEs ) may not be performed with equal frequency on the two sides . This study sought to examine whether right and left CEs are performed with equal frequency and whether there are any differences in outcome between these groups . Detailed chart review was performed on all CEs performed from 1979 through 1998 at our institution , and those lacking side data were excluded . Data were collected on the side of the procedure , demographics , comorbid conditions , details of the procedure , hospital stay , and major complications . The surgeons performing CE were surveyed about their practice of considering side factors . CE was performed on the left in 1190 ( 52 % ) of 2305 procedures ; 1115 ( 48 % ) of the procedures were right CEs . This difference is statistically significant ( P = 0.014 ) . No significant differences in demographics , comorbidity , presence of symptoms before surgery , length of stay , or postoperative morbidity or mortality between the left and right groups were found . A majority of the surgeons surveyed indicated they do consider the relationship of side of the carotid disease to the patient 's dominant side . The significant difference in the performance of left CE more often than right has not been previously reported . This may reflect willingness by surgeons to intervene more frequently in carotid disease on the side supplying the dominant hemisphere . A prospect i ve CE outcome study that identifies the side of CE and the patient 's dominant side is needed for further exploration of this issue BACKGROUND The objective of this study was to assess whether carotid endarterectomy is an appropriate treatment for patients with recent cerebrovascular events in the territory supplied by a moderately stenosed ( 30 - 69 % ) internal carotid artery . Results have previously been reported for severe ( 70 - 99 % ) and mild ( 0 - 29 % ) stenosis . METHODS A multicentre r and omised controlled trial recruited 1599 patients with moderate stenosis treated in 97 hospitals from 15 countries . 60 % of patients were allocated to receive and 40 % to avoid carotid endarterectomy . The analysis was by intention to treat . FINDINGS Nine patients were omitted from the analysis because no follow-up data were received . Stroke-free life expectancy ( curtailed at 8 years ) was shorter in the surgery patients than in the non-surgery control groups ( patients with 30 - 49 % stenosis , life expectancy = 6.16 years [ controls : 6.63 years ] ; patients with 50 - 69 % stenosis , life expectancy = 5.93 [ 6.14 ] years ) . It remains possible that patients might derive some benefit from surgery in the very long term ; however , our data show that no benefit would be gained over a period of < 4 - 5 years in patients with 50 - 69 % stenosis and < 6 - 7 years in patients with 30 - 49 % stenosis . INTERPRETATION Previous interim results from this study showed that surgery is beneficial in patients with severe stenosis but harmful in those with mild stenosis . With more r and omised patients and longer follow-up , the study now shows that endarterectomy is not indicated for most , possibly all , patients with moderate symptomatic carotid stenosis BACKGROUND AND PURPOSE This study reports the surgical results in those patients who underwent carotid endarterectomy in the North American Symptomatic Carotid Endarterectomy Trial ( NASCET ) . METHODS The rates of perioperative stroke and death at 30 days and the final assessment of stroke severity at 90 days were calculated . Regression modeling was used to identify variables that increased or decreased perioperative risk . Non outcome surgical complications were summarized . The durability of carotid endarterectomy was examined . RESULTS In 1415 patients there were 92 perioperative outcome events , for an overall rate of 6.5 % . At 30 days the results were as follows : death , 1.1 % ; disabling stroke , 1.8 % ; and nondisabling stroke , 3.7 % . At 90 days , because of improvement in the neurological status of patients judged to have been disabled at 30 days , the results were as follows : death , 1.1 % ; disabling stroke , 0.9 % ; and nondisabling stroke , 4.5 % . Thirty events occurred intraoperatively ; 62 were delayed . Most strokes result ed from thromboembolism . Five baseline variables were predictive of increased surgical risk : hemispheric versus retinal transient ischemic attack as the qualifying event , left-sided procedure , contralateral carotid occlusion , ipsilateral ischemic lesion on CT scan , and irregular or ulcerated ipsilateral plaque . History of coronary artery disease with prior cardiac procedure was associated with reduced risk . The risk of perioperative wound complications was 9.3 % , and that of cranial nerve injuries was 8.6 % ; most were of mild severity . At 8 years , the risk of disabling ipsilateral stroke was 5.7 % , and that of any ipsilateral stroke was 17.1 % . CONCLUSIONS The overall rate of perioperative stroke and death was 6.5 % , but the rate of permanently disabling stroke and death was only 2.0 % . Other surgical complications were rarely clinical ly important . Carotid endarterectomy is a durable procedure The Feasibility And Safety Trial for its embolic protection device during transluminal intervention in coronary vessels : a European Registry ( FASTER ) was design ed to demonstrate that ( 1 ) the Proxis embolic protection system can control antero grade flow and reverse blood flow in native coronary arteries and saphenous vein grafts ; and ( 2 ) this system can capture embolic debris . Percutaneous coronary intervention on stenotic coronary lesions revolutionized treatment of coronary disease , but is associated with the risk of major adverse cardiac events . This prospect i ve , nonr and omized , multicenter clinical feasibility and safety study enrolled 40 patients with 51 lesions at 4 centers who underwent treatment of stenotic lesions with proximal emboli protection ( Proxis system ) . Proxis was successfully used 95 % of the time , and embolic debris was qualitatively identified in all cases . Major adverse cardiac events occurred in 2 patients ( 5.0 % ) : 1 late in-stent thrombosis result ing in death and 1 non-Q-wave infa rct ion when a lesion was crossed before deployment of the Proxis system . Mean vessel occlusion time was 4.3 + /- 2.4 minutes . Native flow reversal was sufficient in 31 patients , with a mean aspirate volume of 11.8 + /- 6.5 ml . When the infusion catheter was used to augment reflow , mean occlusion time was 4.6 minutes . In conclusion , this trial is the first to demonstrate that retro grade blood flow can be achieved during proximal occlusion and that the Proxis system can be used safely during intervention of saphenous vein grafts and native coronary arterial lesions to capture embolic material BACKGROUND The efficacy of carotid endarterectomy for selected patients has been evaluated with r and omized controlled clinical trials . The generalizability of these studies to average surgical practice remains an important public health concern . OBJECTIVE The objective of the study was to determine the predictors of outcome after carotid endarterectomy on a regional basis . PATIENTS AND METHODS The study was design ed as a retrospective cohort study and included all consecutive patients presented for carotid endarterectomy at the 8 University of Toronto-affiliated hospitals in the period from January 1 , 1994 , to December 31 , 1996 . The main outcome measure was 30-day postoperative stroke or death rate . RESULTS During the study interval , 1280 primary carotid endarterectomies were performed . The overall combined stroke and death rate was 6.3 % for all patients who underwent endarterectomy ( 4.0 % for patients who were asymptomatic ) . The significant predictors of poor outcome were the following : presenting symptoms ( odds ratio , 1.74 ; 95 % confidence interval [ CI ] , 0.96 , 3.12 ) , low surgeon volume ( < 6 cases per year ; odds ratio , 3.98 ; 95 % CI , 1.65 , 9.58 ) , and left-sided surgery ( odds ratio , 1.72 ; 95 % CI , 1.07 , 2.76 ) . CONCLUSION These data suggest that adoption of the recommendations of the symptomatic carotid endarterectomy trials is appropriate . However , endarterectomy for asymptomatic lesions remains of uncertain benefit on a regional basis and must be individualized to the experience of the specific surgeon . The surgeon volume/ outcome relationship that is identified in this study suggests a need for a minimum volume threshold for this procedure 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 every 4 months . End points were assessed by blinded , independent case review . No patient was lost to follow-up . RESULTS Life-table estimates of the cumulative risk of any ipsilateral stroke at two years were 26 percent in the 331 medical patients and 9 percent in the 328 surgical patients --an absolute risk reduction ( + /- SE ) 17 + /- 3.5 percent ( P less than 0.001 ) . For a major or fatal ipsilateral stroke , the corresponding estimates were 13.1 percent and 2.5 percent -- an absolute risk reduction of 10.6 + /- 2.6 percent ( P less than 0.001 ) . Carotid endarterectomy was still found to be beneficial when all strokes and deaths were included in the analysis ( P less than 0.001 ) . CONCLUSIONS Carotid endarterectomy is highly beneficial to patients with recent hemispheric and retinal transient ischemic attacks or nondisabling strokes and ipsilateral high- grade stenosis ( 70 to 99 percent ) of the internal carotid artery BACKGROUND Our objective was to assess the risks and benefits of carotid endarterectomy , primarily in terms of stroke prevention , in patients with recently symptomatic carotid stenosis . METHODS This multicentre , r and omised controlled trial enrolled 3024 patients . We enrolled men and women of any age , with some degree of carotid stenosis , who within the previous 6 months had had at least one transient or mild symptomatic ischaemic vascular event in the distribution of one or both carotid arteries . Between 1981 and 1994 , we allocated 1811 ( 60 % ) patients to surgery and 1213 ( 40 % ) to control ( surgery to be avoided for as long as possible ) . Follow-up was until the end of 1995 ( mean 6.1 years ) , and the main analyses were by intention to treat . FINDINGS The overall outcome ( major stroke or death ) occurred in 669 ( 37.0 % ) surgery-group patients and 442 ( 36.5 % ) control-group patients . The risk of major stroke or death complicating surgery ( 7.0 % ) did not vary substantially with severity of stenosis . On the other h and , the risk of major ischaemic stroke ipsilateral to the unoperated symptomatic carotid artery increased with severity of stenosis , particularly above about 70 - 80 % of the original luminal diameter , but only for 2 - 3 years after r and omisation . On average , the immediate risk of surgery was worth trading off against the long-term risk of stroke without surgery when the stenosis was greater than about 80 % diameter ; the Kaplan-Meier estimate of the frequency of a major stroke or death at 3 years was 26.5 % for the control group and 14.9 % for the surgery group , an absolute benefit from surgery of 11.6 % . However , consideration of variations in risk with age and sex modified this simple rule based on stenosis severity . We present a graphical procedure that should improve the selection of patients for surgery . INTERPRETATION Carotid endarterectomy is indicated for most patients with a recent non-disabling carotid-territory ischaemic event when the symptomatic stenosis is greater than about 80 % . Age and sex should also be taken into account in decisions on whether to operate OBJECTIVES Neurologic complications during carotid artery stenting ( CAS ) are most clearly associated with embolization of visible debris . Distal filter devices may provide cerebr \n Output:\n " }, { "from": "agent", "value": "Left-sided CE is consistently associated with higher postoperative adverse event 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: To investigate the influence of alcohol on glucose counterregulation and recovery during acute insulin-induced hypoglycemia in type 2 diabetic subjects , 8 diet-treated type 2 diabetic subjects were examined twice after an overnight fast . A grade d hyperinsulinemic ( 1 mU/kg/min , 60 to 195 minutes ) euglycemic/hypoglycemic clamp was performed with concomitant infusion of 3-(3)H-glucose to assess glucose turnover . After a euglycemic baseline period ( 150 to 180 minutes ) , 200 mL of water was taken either alone or with alcohol ( 0.4 g/kg body weight ) . Hypoglycemia ( plasma glucose nadir , 2.8 mmol/L ) was subsequently induced , and the recovery period followed after discontinuation of insulin and the variable glucose infusion . On both study days , circulating concentrations of insulin and glucose were comparable . Alcohol intake markedly increased plasma lactate ( area under the curve [ AUC ] , recovery period ) ( 244 + /- 30 v 12 + /- 4 mmol/L x 240 minutes ; P = .00009 ) and suppressed plasma nonesterified fatty acids ( NEFA ) ( AUC , recovery period ) ( 95 + /- 13 v 161 + /- 18 mmol/L x 240 minutes ; P = .0008 ) . No differences were found in the counterregulatory response of catecholamines , cortisol , and growth hormone ( GH ) . However , alcohol intake decreased peak glucagon significantly ( 155 + /- 12 v 200 + /- 17 pg/mL ; P = .038 ) . In diet-treated , mild type 2 diabetic subjects , alcohol does not modify recovery from insulin-induced hypoglycemia Meta-analytic investigations sometimes use assessment s of research quality according to a formal protocol as a tool for improving research synthesis . We asked whether a particular quality scoring system could have a direct use in adjusting the summary estimates of a treatment difference . In an empirical study of the relation of quality scores to treatment differences in published meta-analyses of 7 groups of controlled r and omized clinical trials comprising 107 primary studies , we found no relation between treatment difference and overall quality score . We also found no relation between quality score and variation in treatment difference . The level of quality scores has increased at a rate of 9 % per decade for three decades , averaging 0.51 on a scale of 0 to 1 for the 1980s , and leaving much room for improvement . Nevertheless , attention to quality of studies by editors , review ers , and authors may be raising both the level of research done and quality of the reports Dupuytren 's disease or palmar fibromatosis is a common disabling h and disorder , mainly confined to Caucasians of northwestern European origin . The prevalence of Dupuytren 's disease and possible risk factors related to the disease were evaluated in a r and om sample of 1297 males and 868 females , aged 46 to 74 years . Blood sample s were collected and biochemical parameters were evaluated . The possible relation between the disease and clinical , social , and biochemical parameters were estimated with age-adjusted univariate logistic regression analysis . Altogether 19.2 % of the males and 4.4 % of the female participants had clinical signs of Dupuytren 's disease . The prevalence increased with age , from 7.2 % among males in the age group 45 - 49 years up to 39.5 % in those 70 - 74 years old . The more severe form of the disease , finger contractures , was found in 5.0 % of the men and 1.4 % had required operation , while this was rarely seen among women . In men elevated fasting blood glucose ( P < 0.04 ) , low body weight , and body mass index were significantly correlated with the presence of the disease ( P < 0.001 ) . Dupuytren 's disease was common among heavy smokers ( P = 0.02 ) and those having manual labor as occupation ( P = 0.018 ) . These results show that Dupuytren 's disease is common in the Icel and ic population and occupation and lifestyle seem to be related to the disease A comparative prospect i ve study of 120 adult diabetics ( 60 insulin dependent , 60 non-insulin dependent ) and 120 non-diabetic adults as controls showed significantly higher incidence of Dupuytren 's disease , limited joint motion , carpal tunnel syndrome , and flexor tenosynovitis in the diabetic population . Of the diabetic patients one third had a mild non-progressive form of Dupuytren 's disease , which commonly involved the long and ring rays . Limited joint motion was noted in a third of diabetics , and carpal tunnel syndrome was observed in 15 - 25 % , and flexor tenosynovitis in about a fifth . Limited joint motion co-existed with Dupuytren 's disease in 57 % of insulin-dependent diabetics . Diabetic polyneuropathy was found in two thirds of insulin-dependent diabetics and in one third of non-insulin dependent diabetics . All these h and changes were more marked in insulin-dependent diabetics and they showed a positive correlation with increasing age of the patient , duration of the diabetes , and the presence of a microangiopathy This prospect i ve study was undertaken to assess the prevalence of Dupuytren 's contracture ( DC ) and its relationship with possible causes , especially alcohol consumption and chronic liver disease . Four hundred thirty-two consecutively hospitalized patients were examined for evidence of DC . They were divided into five groups based on the following clinical , biologic , and histologic criteria : alcoholic cirrhosis ( 89 patients ) , noncirrhotic alcoholic liver disease ( 55 patients ) , chronic alcoholism without liver disease ( 46 patients ) , nonalcoholic chronic liver disease ( 68 patients ) , and a control group ( 174 patients ) . The prevalence of DC in these five groups of patients was 32.5 % , 22 % , 28 % , 6 % , and 12 % , respectively ; the prevalence of DC was higher in patients with cirrhotic or noncirrhotic alcoholic liver disease ( 25.5 % ) than it was in patients with nonalcoholic liver disease ( 6 % ) , but it was not significantly different in alcoholic patients with or without liver disease . The relationship between DC and age , sex , manual labor , previous h and injuries , diabetes mellitus , alcohol consumption , and cigarette smoking was assessed by univariate and logistic regression methods . Nine variables were significantly different in patients with or without DC : age , sex , manual labor , previous h and injuries , diabetes mellitus , daily alcohol consumption , duration of alcohol consumption , total alcohol consumption , and duration of cigarette smoking . In our patients , variables that could explain DC were , in decreasing order , age , total alcohol consumption , sex ( male ) , and previous h and injuries . In alcoholic patients , these variables were age and previous h and injuries ; in nonalcoholic patients , these variables were age and cigarette smoking . These results emphasize the high prevalence of DC in alcoholic patients and the absence of a correlation between DC and chronic liver disease . Age and alcohol consumption are the best explanatory variables of DC in hospitalized patients The musculoskeletal complications of diabetes mellitus ( DM ) , which are the most common endocrine arthropathy , have been generally ignored and poorly treated compared with other complications such as neuropathy , retinopathy and nephropathy . Like other quality of life issues , the musculoskeletal disability of DM has not been investigated effectively . The incidence of diabetic foot has decreased thanks to excellent foot care , but the h and is still an important target for diabetic complications . The aim of this study was to investigate early diabetic musculoskeletal complications on the basis of a collaborative multidisciplinary study design . For this purpose 78 patients ( mean age 57.8 ± 11.9 years , 55 women and 23 men ) who had type II DM for 15 years maximally and 37 non-diabetic controls ( mean age : 55.7 ± 11.5 , 27 women and 10 men ) were r and omly selected for inclusion in the study . All patients were evaluated by the Rheumatology , Orthopedic Rehabilitation and H and Rehabilitation Divisions . Dupuytren 's disease was present in 17 ( 21.8 % ) of 78 diabetic subjects as the most frequent and statistically significant complication of the musculoskeletal system . In correlation and logistic regression analysis , only retinopathy was significantly associated with duration of diabetes and diabetic foot . Long-term prospect i ve r and omised controlled trials on the effects of exercise in preventing musculoskeletal complications and disability in diabetics are needed Sixty Type 1 ( insulin dependent ) and sixty Type 2 ( non insulin dependent ) diabetic patients attending a diabetology unit were examined in search of limited joint mobility , Dupuytren 's disease , flexor tenosynovitis and carpal tunnel syndrome , in comparison with two population s of 60 non diabetic controls matched for sex and age with the Type 1 and the Type 2 diabetic patients . Microangiopathic and neuropathic complications , glycaemic control , blood pressure and tobacco consumption were simultaneously assessed in 39 of the 60 type 1 and in all the type 2 diabetic patients . The prevalence of the various soft tissue h and lesions was higher in both diabetic population s ( respectively Type 1 and Type 2 ) than in their control population s : Limited joint mobility : 33.3 and 26.7 % vs 5.0 and 8.3 % ( both p < 0.01 ) ; Dupuytren 's disease : 35.0 and 30.0 % vs 6.7 and 10.0 % ( both p < 0.01 ) ; flexor tenosynovitis : 23.3 and 16.7 % vs 0.0 and 3.3 % ( p < 0.01 and p < 0.05 ) ; carpal tunnel syndrome : 26.7 and 15.0 % vs 3.3 and 5 % ( p < 0.01 and NS ) . The prevalence of limited joint mobility in Type 1 diabetes was independently associated with increasing age ( p < 0.05 ) and to lower extent with increasing duration of diabetes ( p = 0.05 ) , whereas the prevalence of Dupuytren 's disease only correlated with increasing age in both types of diabetes ( p < 0.05 ) . In Type 2 diabetes , the prevalence of flexor tenosynovitis also increased independently with age ( p < 0.05 ) , and the prevalence of limited joint mobility increased in the opposite way to the body mass index after adjustment on age , duration of diabetes and sex ( p < 0.05 ) . ( ABSTRACT TRUNCATED AT 250 WORDS Development of Dupuytren 's contractures , frozen shoulder , Ledderhose 's syndrome , Peyronie 's disease , fibromas , and general joint pain has been linked in retrospective studies and case reports to the use of antiepileptic drugs . We undertook a prospect i ve survey of the incidence of connective tissue disorders in 622 patients newly treated with carbamazepine , phenobarbital , phenytoin sodium , or primidone . Ten of the 406 patients who were treated for 6 months or more developed connective tissue disorders . All affected patients were taking a barbiturate ( primidone , 4 patients ; phenobarbital , 6 patients ) . Seven of the 10 problems occurred during the first year of treatment . These data are prospect i ve evidence of a statistically significant relationship between barbiturate use and the development of connective tissue disorders , and timing of appearance A study of 197 epileptic out patients consecutively observed by one Neurologist allowed a prospect i ve study of the side effects of antiepileptic drugs . This study shows essentially that a clinical improvement comparable to that generally reported can be obtained with side effects limited in their number and intensity . The main principle is the routine search of these effects which are not always spontaneously mentioned by the patients , especially intellectual slowness and loss of sexual activity . The detection of the side effects through history and physical examination is far more fruitful than are plasma concentrations of drugs which can be doubly misleading : some plasma concentrations lower than recognized therapeutical levels are efficient however while others are higher and nevertheless necessary and well tolerated . Among the side effects specific to certain antiepileptic drugs , shoulder-h and syndrome due to phenobarbital was noted in 10 per cent of the cases . Furthermore , the frequency of scapulo-humeral periarthritis was significantly higher in the epileptic group than in the controls . Dupuytren 's disease was less frequent ( 8 per cent ) and the difference with the controls was not significant . Among the non-specific side effects , nystagmus is a somewhat useful sign in treatments by phenytoin but as with drugs dosages , it must be weighed within the whole clinical picture Prospect i ve study of 280 diabetic adults and 100 control show an association of limited joint mobility ( LJM ) with Dupuytren 's contracture ( DC ) in 37 diabetic and no one of control case . In 80 diabetic with LJM , DC is found in 46.25 p. cent against 21 p. cent in 200 diabetic without LJM ( p less than 0.00003 ) . LJM and DC are significantly related to diabetic retinopath \n Output:\n " }, { "from": "agent", "value": "Conclusions : These findings demonstrate an association between Dupuytren disease and diabetes mellitus , liver disease , and epilepsy ." } ]

[ { "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 The purpose of this r and omized controlled trial was to test the efficacy and effectiveness of process consultation consisting of a series of nurse manager-consultant problem-solving meetings for leadership development that would lead to their staff 's improved morale , quality of care , and reduced absenteeism . METHODS Thirteen consenting clinical inpatient units were stratified for four variables known to affect outcome and were then r and omly assigned to treatment and control conditions . The nurse managers from the seven experimental units were paired with outside nurse consultants from the McMaster University School of Nursing ( Hamilton , Ontario , Canada ) in a cooperative form of retraining in problem-solving through process consultation . Morale was determined through measures of perceptions of the work environment , an attitude scale concerning work ( alienation ) , a personality measure ( hardiness ) , and one of each scale for work satisfaction and for sources of satisfaction and dissatisfaction . Demographic data and information regarding family life responsibilities were collected as well . Assessment of quality of care was determined by the frequency and type of incident reports and by patients ' perception of their satisfaction . A ratio of absence hours to total paid hours of work was used to compare experimental and control units ' absenteeism rates . RESULTS Experimental subjects reported a statistically significant improvement in the characteristics of their work setting and in the quality of working relationships . The consultation process facilitated a perceived change in the organizational context of the experimental hospital units with less central ization of authority and more clarity about expectation . These organizational changes were accompanied by improved working relationships and less alienation from work . There was no statistically significant difference in absenteeism . However , a sub analysis of the units by \" dose \" of the intervention identified those who benefited from the effects of the consultation . Subjects whose nurse managers participated more actively in the consultation process accounted for the changes in working relationships and perceived organizational changes . The \" low-dose \" experimental subjects were more like the control subjects , with the exception of absenteeism , for which they had higher rates . CONCLUSIONS The findings of this study suggest that process consultation can alter the staff 's perceptions of the characteristics of the work setting , can reverse negative attitudes ( alienation ) , and can create a more positive and supportive working environment ( improved working relationship ) . However , the results suggest the need to target this type of intervention to managers who have the personal re sources to engage in self-evaluation and personal development and thus to participate in the consultative process Purpose . This study analyzed correlates of workers ' perceptions of the extent to which their work environment is healthy and how these perceptions influence job satisfaction , employee commitment , workplace morale , absenteeism , and intent to quit . Design . One-time cross-sectional telephone survey . Setting . Canadian employees in 2000 . Subjects . A r and omly chosen , nationally representative sample of 2500 employed respondents , using a household sampling frame . The response rate was 39.2 % . Self-employed individuals were excluded , leaving a sub sample of 2112 respondents . Measures . The dependent variable was the response to the item , “ The work environment is healthy ” ( 5-point strongly agree – strongly disagree Likert scale ) . Independent variables used in bivariate and ordinary least-squares regression analyses included sociodemographic characteristics , employment status , organizational characteristics , and scales that measured job dem and s , intrinsic rewards , extrinsic rewards , communication/social support , employee influence , and job re sources . Perceptions of a healthy work environment were related to job satisfaction , commitment , morale ( measured on a 5-point scale ) , number of self-reported absenteeism days in the past 12 months , and whether or not the respondent had looked for a job with another employer in the past 12 months . Results . The strongest correlate of a healthy work environment was a scale of good communication and social support ( beta = .27 ) . The next strongest was a job dem and s scale ( beta = –.15 . ) Employees in self-rated healthier work environments had significantly ( p < 0.01 ) higher job satisfaction , commitment and morale , and lower absenteeism and intent to quit . Conclusions . The study supports a comprehensive model of workplace health that targets working conditions , work relationships , and workplace organization for health promotion interventions BACKGROUND High rates of work-related injuries are seen among health care workers involved in lifting and transferring patients . We studied the effects of a participatory worker-management ergonomics team among hospital orderlies . METHODS This prospect i ve intervention trial examined work injuries and other outcomes before and after the intervention , with other hospital employees used as a concurrent control . All orderlies in a 1,200-bed urban hospital were studied using passively collected data ( mean employment during study period 100 - 110 orderlies ) ; 67 orderlies ( preintervention ) and 88 orderlies ( postintervention ) also completed a question naire . The intervention was the formation of a participatory ergonomics team with three orderlies , one supervisor , and technical advisors . This team design ed and implemented changes in training and work practice s. RESULTS The 2-year postintervention period was marked by decreased risks of work injury ( RR = 0.50 , 95 % CI 0.35 - 0.72 ) , lost time injury ( RR = 0.26 , 95 % CI 0.14 - 0.48 ) , and injury with three or more days of time loss ( RR = 0.19 , 95 % CI 0.07 - 0.53 ) . Total lost days declined from 136.2 to 23.0 annually per 100 full-time worker equivalents ( FTE ) . Annual workers ' compensation costs declined from $ 237/FTE to $ 139/FTE . The proportion of workers with musculoskeletal symptoms declined and there were statistically significant improvements in job satisfaction , perceived psychosocial stressors , and social support among the orderlies . CONCLUSION Substantial improvements in health and safety were seen following implementation of a participatory ergonomics program The aim of this Intervention was to evaluate the effect of training on patient-h and ling skills and prospect ively to assess the effect of skill on subsequent back pain and back injuries in nursing . Of a total of 255 nurses , 199 were assessed for their skill in patient-h and ling . One-half ( control group ) received traditional training in patient-h and ling , and the other half ( trained group ) received a curriculum of instruction totaling 40 hours . The skills of both groups were assessed on graduation . The control group was rated as less competent in patient-h and ling . Nurses in both groups were question ed about the prevalence of back pain and incidence of back injuries in the first year after graduation . In multiple regression analysis , the major risk Indicators for back injuries were poor patient-h and ling skill , low numbers of repetitions in the sit-up test , and high work-load scores . High score on the hysteria scale of Middlesex Hospital Question naire was a risk Indicator for all kinds of back pain . Though back pain was Independent of patient-h and ling skill , those rated as “ bad ” or “ poor ” had more back injuries ( 24 % ) than those who had been rated as “ good ” or “ excellent ” ( 2 % ) ( P < 0.001 ) , but the difference between the trained and control groups was not statistically significant . It was concluded that back Injuries may be prevented by the teaching of patient-h and ling skills OBJECTIVE The effects and constancy of a worksite physical exercise intervention were examined in relation to the physical fitness , perceived health status , and work ability of female service workers during periods of 1 and 5 years . METHODS The subjects comprised female home care workers divided into an intervention group ( n = 50 , mean age 41.8 ( SD 10.4 ) years ) and a control group ( n = 37 , mean age 43.3 ( SD 8.8 ) years ) . The intervention group participated in 9 months of supervised exercise intervention twice a week during the workday . Functional capacity , perceived health , and work ability were assessed at the beginning of the study and after a 1- and a 5-year period of follow-up . RESULTS In the 1-year follow-up measurements , body fat had decreased ( 4 % ) and dynamic muscle performance and maximal oxygen consumption in relation to body mass ( 30 - 38 and 7 % , respectively ) had increased in the intervention group . The differences in outcome variables between the intervention and the control groups were significant ( from P = 0.014 to P < 0.001 ) . These positive effects of worksite exercise were observed despite the age of the subjects , and the changes were consistent during a 5-year period . In the control group the decline of the work ability index ( L smean ) was about three times faster than in the intervention group during the 5-year period . CONCLUSIONS Physical exercise executed in work units can be used to improve the physical capacity of female home care aides and prevent the early decline of their work ability . In jobs that are physically dem and ing , such as home care work , early prevention must start before the age-related deterioration of health and physical capacity CONTEXT Low back pain is a frequent and costly health problem . Prevention of low back pain is important both for the individual patient and from an economic perspective . OBJECTIVE To assess the efficacy of lumbar supports and education in the prevention of low back pain in industry . DESIGN A r and omized controlled trial with a factorial design . SETTING The cargo department of an airline company in the Netherl and s. PARTICIPANTS A total of 312 workers were r and omized , of whom 282 were available for the 6-month follow-up . INTERVENTIONS Subjects were r and omly assigned to 4 groups : ( 1 ) education ( lifting instructions ) and lumbar support , ( 2 ) education , ( 3 ) lumbar support , and ( 4 ) no intervention . Education consisted of 3 group sessions on lifting techniques with a total duration of 5 hours . Lumbar supports were recommended to be used during working hours for 6 months . MAIN OUTCOME MEASURES Low back pain incidence and sick leave because of back pain during the 6-month intervention period . RESULTS Compliance with wearing the lumbar support at least half the time was 43 % . In the 282 subjects for whom data were available , no statistically significant differences in back pain incidence ( 48 [ 36 % ] of 134 with lumbar support vs 51 [ 34 % ] of 148 without , P=.81 ) or in sick leave because of low back pain ( mean , 0.4 days per month with lumbar support vs 0.4 days without , P=.52 ) were found among the intervention groups . In a subgroup of subjects with low back pain at baseline , lumbar supports reduced the number of days with low back pain per month ( median , 1.2 vs 6.5 days per month ; P=.03 ) . CONCLUSIONS Overall , lumbar supports or education did not lead to a reduction in low back pain incidence or sick leave . The results of the subgroup analysis need to be confirmed by future research . Based on our results , the use of education or lumbar supports can not be recommended in the prevention of low back pain in industry Aims : To investigate the effectiveness of a worksite health promotion programme by individual counselling on sick leave . Methods : Three municipal services of Enschede , the Netherl and s , participated in this trial . A total of 299 civil servants were measured at baseline and were r and omised by cluster into the intervention ( n = 131 ) or the control group ( n = 168 ) . During nine months , subjects in the intervention group received a total of seven consultations , particularly aim ed at increasing their physical activity level and improving their dietary habits . Both the intervention and the control subjects received written information as to several lifestyle factors . Sick leave data regarding the nine month intervention period ( from May until January ) were collected from each municipal service ’s personnel department . In addition , sick leave data concerning the nine month period pre- and post-intervention were collected . Sick leave data were analysed using multilevel analysis . Results : For both groups , the mean sick leave rate during the intervention increased compared to before the intervention . After the intervention period , the control group increased even more ( from 22.9 to 27.6 days ) , whereas the intervention group slightly decreased ( from 21.5 to 20.5 days ) . Median values of sick leave rate decreased for both groups . No statistically significant intervention effect was found . In both groups , the mean sick leave frequency slightly decreased over time ( intervention effects were not significant ) . Conclusions : Results showed no significant effect of individual counselling on sick leave . Continued research investigating the effectiveness of this individual counselling programme on several health related outcomes is useful to clarify the trend observed in sick leave OBJECTIVES This multicentered r and omized controlled trial evaluated the effect of worksite exercise intervention on perceived work ability and sick leaves . METHODS Women ( N = 260 , mean age 40 years ) engaged in physically dem and ing laundry work were individually r and omized into an intervention ( N = 133 ) or control ( N = 127 ) group . Perceived work ability was assessed with question naires at 3 , 8 , 12 , and 15 months . Sick leave information was obtained from the personnel administration . Follow-up attendance was 100 % at 3 months but declined gradually to 90 % by 15 months . Both the intervention and control subjects received a 30-minute feedback on their physical capacity from a physiotherapist and individual exercise prescription and counseling . The intervention subjects also participated in worksite exercise training guided by a physiotherapist . Sixty-minute sessions ( N = 26 ) were held once a week for 8 months . About 50 % of the intervention group participated in at least two-thirds of the sessions . RESULTS According to a dichotomized work ability index , at 12 months , workers with \" good \" or \" excellent \" work ability increased more in the intervention group than in the control group ( 11.0 % , 95 % CI 0.2 - 21.9 ) , as did the health-related prognosis of work ability at 8 months ( 8.1 % , 95 % CI \n Output:\n " }, { "from": "agent", "value": "Exercise seems to increase overall well-being ( RR , 1.25 ; range , 1.05 to 1.47 ) and work ability ( RR , 1.38 ; range , 1.15 to 1.66 ) , but education and psychological methods do not seem to affect well-being or sickness absences .\nWork health promotion is valuable on employees ' well-being and work ability and productive in terms of less sickness absences .\nActivities involving exercise , lifestyle , and ergonomics are potentially effective .\nOn the other h and , education and psychological means applied alone do not seem 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: OBJECTIVES This pragmatic r and omized trial evaluated the effectiveness of a tailored educational intervention on oral health behaviors and new untreated carious lesions in low-income African-American children in Detroit , Michigan . METHODS Participating families were recruited in a longitudinal study of the determinants of dental caries in 1021 r and omly selected children ( 0 - 5 years ) and their caregivers . The families were examined at baseline in 2002 - 2004 ( Wave I ) , 2004 - 2005 ( Wave II ) and 2007 ( Wave III ) . Prior to Wave II , the families were r and omized into two educational groups . An interviewer trained in applying motivational interviewing principles ( MI ) review ed the dental examination findings with caregivers assigned to the intervention group ( MI + DVD ) and engaged the caregiver in a dialogue on the importance of and potential actions for improving the child 's oral health . The interviewer and caregiver watched a special 15-minute DVD developed specifically for this project based on data collected at Wave I and focused on how the caregivers can ' keep their children free from tooth decay ' . After the MI session , the caregivers developed their own preventive goals . Some families in this group chose not to develop goals and were offered the project-developed goals . The goals , if defined , were printed on glossy paper that included the child 's photograph . Families in the second group ( DVD-only ) were met by an interviewer , shown the DVD , and provided with the project 's recommended goals . Both groups of families received a copy of the DVD . Families in the MI + DVD group received booster calls within 6 months of the intervention . Both caregivers and the children were interviewed and examined after approximately 2 years ( Wave III : 2007 ) . RESULTS After 6-month of follow-up , caregivers receiving MI + DVD were more likely to report checking the child for ' precavities ' and making sure the child brushes at bedtime . Evaluation of the final outcomes approximately 2 years later found that caregivers receiving the MI + DVD were still more likely to report making sure the child brushed at bedtime , yet were no more likely to make sure the child brushed twice per day . Despite differences in one of the reported behaviors , children whose caregivers received the motivational intervention did not have fewer new untreated lesions at the final evaluation . CONCLUSIONS This study found that a single motivational interviewing intervention may change some reported oral health behaviors , it failed to reduce the number of new untreated carious lesions This cluster-r and omized pragmatic ( effectiveness ) trial tested maternal counseling based on Motivational Interviewing ( MI ) as an approach to control caries in indigenous children . Nine Cree communities in Quebec , Canada were r and omly allocated to test or control . MI-style counseling was delivered in test communities to mothers during pregnancy and at well-baby visits . Data on outcomes were collected when children were 30 months old . Two hundred seventy-two mothers were recruited from the 5 test and 4 control communities . Baseline characteristics were comparable but not equivalent for both groups . At trial ’s end , 241 children had follow-up . The primary analysis outcome was enamel caries with substance loss ( d2 ) ; no statistically significant treatment effect was detected . Prevalence of treated and untreated caries at the d2 level was 76 % in controls vs. 65 % in test ( p = 0.17 ) . Exploratory analyses suggested a substantial preventive effect for untreated decay at or beyond the level of the dentin , d3 ( prevalences : 60 % controls vs. 35 % test ) , and a particularly large treatment effect when mothers had 4 or more MI-style sessions . Overall , these results provide preliminary evidence that , for these young , indigenous children , an MI-style intervention has an impact on severity of caries ( clinical trial registration IS RCT N41467632 ) The purpose of the present study was to investigate the frequency of smoking cessation and the use of proximal tooth cleaning routines after a nonsurgical periodontal treatment phase in a Specialist clinic of Periodontology and to evaluate if these behaviour changes had any influence on the periodontal healing results . The investigation was conducted as a retrospective longitudinal study on a r and omly selected population of 100 patients referred for periodontal treatment . The variables were registered from the dental records and the radiographs . Forty-six individuals declared that they were smokers at baseline and one individual of those quitted smoking during the nonsurgical treatment period . The percentage of individuals who performed proximal tooth cleaning daily was significantly increased from 56 % to 72 % during the treatment period . The patients practising proximal tooth cleaning daily had significantly lower Plaque index before as well as after the nonsurgical periodontal treatment phase compared to those without the routine . The subjects who did not perform tooth cleaning daily before the treatment and who did not introduce this routine had significantly deeper periodontal pockets compared to those who performed inter-dental cleaning daily before treatment or who had adopted the routine during the treatment phase . However , there were no significant differences according to number of deepened periodontal pockets after nonsurgical treatment irrespective of proximal cleaning routines . In the future , motivational interviewing may be a more effective method to achieve a behaviour change if an extended education of dental hygienists within this area will be implemented AIM To develop and test the methodology of an intervention to reduce avoidance of dental care among adolescents , and to measure the respondents ' beliefs regarding the intervention ( credibility and cognitions ) . METHODS Based on a group comparison design a sample of 18 year olds ( n=50 ) with dental non-attendance behaviour was r and omly selected to three experimental and one control group . Subjects were surveyed with one baseline question naire and one post-intervention question naire , to evaluate their beliefs regarding the program . Two different instruments were tested : 1 ) cards representing different statements related to previous dental experiences , possible reasons for attending ( pros ) and not attending ( cons ) dental appointments , and preferences for future treatment . Cards were selected based on individual priority ; 2 ) a brief , structured telephone interview based on Motivational Interviewing . The instruments were tested separately ( groups I and II ) and in combination ( group III ) . Subjects in the control group ( group IV ) were given conventional health education . RESULTS Subjects in the experimental groups had significantly higher credibility scores to the statement \" How much easier do you perceive dental treatment to be for you , based on this program \" , compared with the control group ( p<0.05 ) . They had also more positive beliefs to the statement \" I think the interviewer liked to talk to me \" ( p<0.05 ) than controls . CONCLUSION A question naire sent to non-attending adolescents followed by a brief telephone call based on Motivational Interviewing appears to be a credible intervention for adolescents avoiding dental care 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 AIM Because patient adherence to oral hygiene is essential for periodontal treatment success , the aim of the study was to assess whether a motivational interview addressing the five dimensions of Leventhal 's theory performed better than conventional basic instruction on improving compliance with plaque control among patients with periodontitis . MATERIAL S AND METHODS A r and omized controlled clinical trial design was used in which a group of patients underwent a motivational interview in addition to classical consultation . A control group received only the st and ard consultation . The O'Leary Plaque Index was used to judge the oral hygiene at baseline and at 1 month follow-up . Patient satisfaction with the dental visit was scored using a specific question naire . RESULTS At baseline , the mean full mouth plaque score varied between 55 % ( experimental group ) and 58 % ( control group ) . Patients in the experimental group had a higher oral hygiene improvement ( 21 ± 20 % versus 4 ± 5 % , p < 0.001 ) 1 month post-treatment . The motivational interview result ed in greater satisfaction scores compared with those of patients in the control group : 10.55 ± 1.53 versus 8.82 ± 2.40 , p = 0.014 . CONCLUSIONS This new concept of motivational interview is a promising approach and can be useful for counselling-related periodontal disorders PURPOSE The purpose s of this r and omized controlled trial were to : ( 1 ) test motivational interviewing ( MI ) to prevent early childhood caries ; and ( 2 ) use Poisson regression for data analysis . METHODS A total of 240 South Asian children 6 to 18 months old were enrolled and r and omly assigned to either the MI or control condition . Children had a dental exam , and their mothers completed pretested instruments at baseline and 1 and 2 years postintervention . Other covariates that might explain outcomes over and above treatment differences were modeled using Poisson regression . Hazard ratios were produced . RESULTS Analyses included all participants whenever possible . Poisson regression supported a protective effect of MI ( hazard ratio [HR]=0.54 (95%CI=035 - 0.84)-that is , the M/ group had about a 46 % lower rate of dmfs at 2 years than did control children . Similar treatment effect estimates were obtained from models that included , as alternative outcomes , ds , dms , and dmfs , including \" white spot lesions . \" Exploratory analyses revealed that rates of dmfs were higher in children whose mothers had : ( 1 ) prechewed their food ; ( 2 ) been raised in a rural environment ; and ( 3 ) a higher family income ( P<.05 ) . CONCLUSIONS A motivational interviewing-style intervention shows promise to promote preventive behaviors in mothers of young children at high risk for caries BACKGROUND The purpose of this study was to compare the effect of a motivational interviewing ( MI ) counseling visit with traditional health education for mothers of young children at high risk of developing dental caries . METHODS The authors enrolled 240 infants aged 6 to 18 months and their mothers in the study and r and omly assigned them to MI or traditional health education ( control ) groups . Mothers in the control group received a pamphlet and watched a videotape . Those in the MI group received the pamphlet and watched the videotape , as well as received an MI counseling session and six follow-up telephone calls during the first year . There were no interventions in year 2 . RESULTS After two years , children in the MI group exhibited significantly less new caries ( decayed or filled surfaces ) than those in the control group ( that is , a protective effect of MI ) ( odds ratio = 0.35 , 95 percent confidence interval = 0.15 to 0.83 ) . CONCLUSIONS MI is a promising approach that warrants further attention in a variety of dental context s. CLINICAL IMPLICATION S The results of this study show that MI has a protective effect with regard to the development of early childhood caries . One reason for this clinical effect is greater compliance with recommended fluoride varnish treatment regimens in families who received MI counseling compared with families who received traditional education More knowledge is needed regarding what works to prevent oral health problems and reduce disparities in oral health . Motivational interviewing ( MI ) has demonstrated utility for improving health behavior , including among those with severe mental illness . This study tests whether MI enhances the efficacy of an oral health education intervention in individuals with severe mental illness . Sixty individuals were r and omly assigned to MI plus oral health education or oral health education alone . Plaque scores , oral health knowledge , and self-regulation were assessed at baseline and at 4 and 8 weeks . Repeated- measures ANOVA showed improvement ( p < 0.05 ) in plaque , autonomous regulation , and oral health knowledge across time for both groups ; however , individuals receiving MI improved significantly more when compared with those receiving oral health education \n Output:\n " }, { "from": "agent", "value": "Better quality of evidence was provided by studies that investigated dental caries , which also had the largest population sample s. The evidence of the effect of MI on improving oral health outcomes is conflicting .\nWe found inconclusive effectiveness for most oral health 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: Objective To evaluate the effectiveness of relapse prevention ( RP ) and brief intervention ( BI ) in reducing HIV risk-taking behaviours among injecting drug users ( IDU ) enrolled in methadone programmes . The hypotheses tested were : ( 1 ) that a six-session RP programme would be more effective in reducing HIV risk-taking behaviours than a one-session BI and a non-intervention control condition ( C ) ; and ( 2 ) that Bl would be more effective in reducing HIV risk-taking behaviours than C. Design Clients of methadone programmes were r and omly assigned to either RP , Bl , or C. Follow-up occurred 6 months after pre-intervention assessment and was conducted by independent research assistants who were not aware of subjects ' group allocations . Setting Confidential assessment interviews and interventions generally took place at the methadone unit treating the subject . Participants Ninety-five IDU enrolled in methadone programmes . Study entry criteria were : injection of any drug in the 6 months before the day of pre-intervention assessment ; literacy in English ; agreement to HIV-antibody testing for research purpose s ; and no known diagnosis of a serious mental illness . Eighty subjects were contacted successfully for a 6-month follow-up . Interventions The RP intervention was a six-session programme . Each 60–90-min session was conducted individually . The Bl was a one-session motivational interview lasting 60–90 min , accompanied by a self-help booklet . Main outcome measures All subjects were administered the Drug Use Scale and HIV Risk-Taking Behaviour Scale of the Opiate Treatment Index and consented to the collection of a capillary blood sample for HIV-antibody testing at pre-intervention assessment and follow-up . At follow-up , the Highest HIV Risk-Taking Behaviour Scale , collateral reports from subjects ' sexual partners pertaining to the previous month and urinalysis results for the month before follow-up were collected . Results Compliance with interventions was good . Correspondence of self-reports with urinalysis and collateral reports was satisfactory . There were no significant differences between groups in risk-taking behaviours during the month before follow-up . However , there was evidence of a lower rate of needle-risk behaviour ( sharing and cleaning ) during the heaviest risk-taking month since pre-intervention assessment in the group given RP . There were no indications that Bl was of greater benefit than the usual methadone treatment and neither intervention appeared to reduce sexual risk behaviour . Conclusions The results are cautiously interpreted as showing that individual RP programmes decrease the level of needle-risk behaviour during relapse episodes , but further research is required to replicate this finding Peer outreach models have been successful in addressing HIV risk behaviors of drug users . Patients in methadone maintenance treatment programs who were migrants from Puerto Rico and /or familiar with drug use there were trained to conduct HIV-related peer outreach . A group r and omized design was implemented ; patients in the Experimental ( E ) condition ( n = 80 ) received training and conducted 12 weeks of outreach . Half of the patients completed the training and outreach . At follow-up , patients in the E condition who conducted outreach felt they were more helpful to their community , showed a trend for engaging in more vocational activities , and were more likely to talk with others about HIV , compared to those who did not conduct outreach and those in the Control condition ( n = 78 ) . Drug treatment patients who are migrants can be trained as peer outreach workers and short-term benefits were found . Longer term maintenance of benefits should be assessed OBJECTIVES This study evaluated a theory-based community-level intervention to promote progress toward consistent condom and bleach use among selected population s at increased risk for HIV infection in 5 US cities . METHODS Role-model stories were distributed , along with condoms and bleach , by community members who encouraged behavior change among injection drug users , their female sex partners , sex workers , non-gay-identified men who have sex with men , high-risk youth , and residents in areas with high sexually transmitted disease rates . Over a 3-year period , cross-sectional interviews ( n = 15,205 ) were conducted in 10 intervention and comparison community pairs . Outcomes were measured on a stage-of-change scale . Observed condom carrying and intervention exposure were also measured . RESULTS At the community level , movement toward consistent condom use with main ( P < .05 ) and nonmain ( P < .05 ) partners , as well as increased condom carrying ( P < .0001 ) , was greater in intervention than in comparison communities . At the individual level , respondents recently exposed to the intervention were more likely to carry condoms and to have higher stage-of-change scores for condom and bleach use . CONCLUSIONS The intervention led to significant communitywide progress toward consistent HIV risk reduction AIM To assess the effectiveness of a sexual risk reduction intervention in the Russian narcology hospital setting . DESIGN , SETTING AND PARTICIPANTS This was a r and omized controlled trial from October 2004 to December 2005 among patients with alcohol and /or heroin dependence from two narcology hospitals in St Petersburg , Russia . INTERVENTION Intervention subjects received two personalized sexual behavior counseling sessions plus three telephone booster sessions . Control subjects received usual addiction treatment , which did not include sexual behavior counseling . All received a research assessment and condoms at baseline . MEASUREMENTS Primary outcomes were percentage of safe sex episodes ( number of times condoms were used / by number of sexual episodes ) and no unprotected sex ( 100 % condom use or abstinence ) during the previous 3 months , assessed at 6 months . FINDINGS Intervention subjects reported higher median percentage of safe sex episodes ( unadjusted median difference 12.7 % ; P = 0.01 ; adjusted median difference 23 % , P = 0.07 ) ; a significant difference was not detected for the outcome no unprotected sex in the past 3 months [ unadjusted odds ratio ( OR ) 1.6 , 95 % confidence interval ( CI ) 0.8 - 3.1 ; adjusted OR 1.5 , 95 % CI 0.7 - 3.3 ] . CONCLUSIONS Among Russian substance-dependent individuals , sexual behavior counseling during addiction treatment should be considered as one potential component of efforts to decrease risky sexual behaviors in this HIV at-risk population This study examined and compared the effectiveness of two counseling interventions design ed to reduce the HIV drug and sexual risk behaviors of 684 out-of-treatment drug users recruited from South Philadelphia , PA . All study participants received a st and ard intervention and one half were r and omly assigned to also receive the enhanced intervention . The st and ard intervention provided HIV risk reduction education , HIV testing with pretest and posttest counseling , and training in condom use and needle cleaning . The enhanced intervention provided additional information on STD risk reduction . Both interventions were effective in influencing behavior change between baseline and 6-month follow-up . A higher proportion of persons reduced their drug risk behaviors compared to their sexual risk behaviors . As sexual risk behaviors are more resistant to change , there is a need for tailored interventions that target out-of-treatment drug users Many early studies of injecting drug users ( IDUs ) suggested that most HIV infections in this population were due to needle sharing and that sexual transmission was negligible or was overshadowed by parenteral routes . A few of the early studies suggested a potentially important role for heterosexual transmission , but these tended to be limited to cross-sectional data or had only a few years of prospect i ve follow-up . Studies of sexual risk factors for HIV infection among non-injecting drug users ( NIDUs ) are similarly sparse . Recently , investigators prospect ively examined both drug-related and sexual risk factors for HIV seroconversion among male and female IDUs with an adequate number of person-years to identify statistically significant associations . Other studies among never and former IDUs have identified associations suggesting that sexual transmission accounts for a substantial number of HIV seroconversions in these population s. Herein , highlights are discussed from recent investigations among IDUs in Baltimore , Maryl and , and corroborating findings from the literature . Results from a 10-year prospect i ve analysis of the ALIVE study and an analysis of the REACH studies spanning a 7-year period indicate that sexual risk factors for HIV infection are important in both female and male IDUs . These findings underscore the need for HIV interventions among drug users that incorporate sexual risk reduction . Based on the existing literature , a narrow focus on injection-related risks is an ineffective prevention strategy . Interventions that target specific subgroups of high-risk IDUs , such as men who have sex with men and inject drugs ( MSM-IDUs ) , sex worker-IDUs and HIV-infected IDUs , deserve special attention OBJECTIVES We compared the effects of 2 interventions on alcohol use , use of a new syringe at last injection , and condom use at last sexual encounter in a community sample of injection drug users . METHODS Between 2003 and 2006 , 851 out-of-treatment injection drug users were recruited in Raleigh , NC , and Durham , NC , through street outreach and were r and omly assigned to either a 6-session educational intervention or a 6-session motivational intervention . Intervention effects were examined at 6 and 12 months after enrollment . RESULTS In multiple logistic regression analyses adjusted for baseline alcohol use and HCV status , participants assigned to the motivational intervention were significantly less likely than were participants in the educational intervention to be drinking at the 6-month follow-up ( odds ratio = 0.67 ; 95 % confidence interval = 0.46 , 0.97 ) . There were no significant between-group differences in use of a new syringe at last injection or condom use at last sexual encounter at either follow-up . CONCLUSIONS Reducing alcohol use among persons with HCV may slow disease progression and provide important health benefits . Additional strategies are needed for slowing HCV disease progression until more effective HCV treatments are available BACKGROUND Interventions are needed to assist drug abusers in reducing risky drug and sexual behavior . METHODS A r and omized controlled trial compared three small-group AIDS educational interventions among 567 clients of a 21-day inpatient drug detoxification program : a two-session informational intervention , given either during the first ( early ) or second ( late ) week of treatment ; and a six-session enhanced intervention . Changes in knowledge , attitudes , and psychomotor skills were assessed before and after each intervention , and behavioral outcomes were assessed at follow-up 10 to 18 weeks after admission . RESULTS Immediately after the interventions , enhanced group members reported significantly greater self-efficacy to talk themselves out of AIDS-risky behavior ; other knowledge and attitude scales did not differ by intervention . At follow-up , significant reductions in risky drug use were reported by all groups . Enhanced group members reported significantly greater reduction in injection frequency than did late informational subjects . CONCLUSIONS No beneficial effect was detected of delaying AIDS education for clients entering detoxification . At this early stage of follow-up , there is only weak evidence that an enhanced intervention improved outcomes Methadone maintenance programs ( MMP ) have the potential to play an important role in reducing HIV risk , given the appropriate type and level of ancillary treatments . In this study , we investigated the efficacy of a 12-session harm reduction group intervention for injection drug users , based upon the Information-Motivation-Behavioral skills model of behavior change , that focused on reducing both drug and sex risk . Two hundred and twenty patients entering an MMP were r and omized to receive either st and ard care (SC)-2 hours of counseling per month and a single-session risk reduction intervention-or SC plus the harm reduction group ( HRG ) . Results showed that during treatment , patients receiving HRG were more likely to be abstinent from cocaine and to report fewer unsafe sexual practice s. Post-treatment , HRG patients scored higher on a sexual risk quiz and reported increased self-efficacy in high risk sexual situations . Enhancing methadone maintenance with a weekly harm reduction group treatment was somewhat more expensive but can bring about positive changes in behaviors and attitudes that are associated with the transmission of HIV BACKGROUND Methamphetamine use has been associated with rising STI/HIV transmission rates , particularly among men who have sex with men ( MSM ) . Interventions which successfully reduce risk for HIV transmission among this population are a public health priority . This study examined the efficacy of a behavioral intervention for increasing safer sex behaviors in the context of ongoing methamphetamine use in a sample of HIV-positive , methamphetamine-using MSM . METHODS Three-hundred and forty-one participants from San Diego , CA were r and omly assigned to receive either a safer sex behavioral intervention ( EDGE ) or a time-equivalent diet- and -exercise attention-control condition . R and om effects regression analyses were used to evaluate change in safer sex behaviors over a 12-month period . RESULTS Participants in the EDGE intervention engaged in significantly more protected sex acts at the 8-month ( p=0.034 ) and 12-month assessment ( p=0.007 ) . By 12-months post-baseline , a greater percentage of protected sex acts was observed for EDGE ( 25.8 % ) vs. control participants ( 18.7 % ) ( p=0.038 ) . There was a significant time-by-intervention interaction ( p=0.018 ) for self-efficacy for condom use , suggesting that EDGE participants ' self-efficacy demonstrated a greater increase over time compared to control participants . CONCLUSIONS These results suggest that it is possible to reduce high risk sexual behaviors in the context of ongoing methamphetamine use among HIV-infected MSM A community-based HIV intervention for African-American women who are active injection drug users ( IDUs ) was evaluated . Seventy-one women ( aged 20–54 years ) were r and omly assigned to one of two enhanced gender- and culturally specific intervention conditions \n Output:\n " }, { "from": "agent", "value": "Comparison with previous meta-analyses suggested limited progress in recent years in developing more effective interventions .\nMultisession psychosocial and educational interventions provided similar modest sexual risk reduction justifying offering educational interventions in setting s with limited exposure to sexual risk reduction interventions , messages , and re sources" } ]

[ { "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 Patients with completely resected stages I-IV high grade uterine leiomyosarcoma are at high risk for recurrence . No adjuvant treatment has been shown to improve survival , although prospect i ve data are limited . We sought to determine whether adjuvant gemcitabine-docetaxel would yield a 2-year progression-free survival of at least 50 % in this leiomyosarcoma population . METHODS Eligible patients were treated with gemcitabine 900 mg/m(2 ) over 90 min days 1 and 8 plus docetaxel 75 mg/m(2 ) day 8 , every 3 weeks for 4 cycles . CT imaging was performed at baseline , after cycle 4 , and every 3 months . Progression was defined as evidence of new disease on CT . RESULTS Twenty-five patients ( median age 49 ; range , 37 - 73 ) enrolled ; 23 were evaluable ( 1-never treated , 1-ineligible ) . With median follow-up of 49 months for all patients , 10 ( 45 % ) of the 23 evaluable patients remained progression free at 2 years , with a median progression-free survival of 13 months . The median overall survival is not yet reached . Among the 18 patients with stages I or II uterine leiomyosarcoma , 59 % remain progression-free at 2 years , with a median progression-free survival of 39 months . Median overall survival for stages I and II patients is not yet reached with median follow-up duration of 49 months . Sites of first recurrence were : lung only - 3/23 ( 13 % ) ; pelvis only - 5/23 ( 22 % ) ; both - 5 ( 22 % ) . CONCLUSIONS Post-resection gemcitabine-docetaxel for stages I-IV high- grade uterine leiomyosarcoma yields 2-year progression-free survival rates that appear superior to historical rates . Gemcitabine-docetaxel merits further study as part of an adjuvant strategy for patients with completely resected , early-stage uterine leiomyosarcoma PURPOSE To determine the long-term outcome of uterine fibroid therapy ( UFE ) using tris-acryl gelatin microspheres ( TAGM ) . MATERIAL S This was a multicenter prospect i ve study of patients undergoing UFE with TAGM , and during this phase of the study , the clinical outcomes 3 years after treatment were assessed . Measures of outcome included the Ruta Menorrhagia Question naire , patient self- assessment s of symptoms and impact on activities , patient satisfaction and health-related quality of life as measured by the SF-12 . Long-term re-intervention rates were also assessed . The data were analyzed at each interval compared to baseline using appropriate statistical tests . RESULTS Of the 102 patients enrolled , 96 patients had complete baseline data and of these , 69 ( 72 % ) had known outcomes at 3 years after treatment . Sixty-one patients ( 64 % ) completed long-term follow-up without major intervention . An additional 8 patients ( 8.3 % ) underwent fibroid surgery ( 7 hysterectomies and 1 myomectomy ) . Among those without intervention , at 3 years after treatment , the mean Ruta Question naire Score was 19.3 , compared to 47.9 at baseline and 24.5 at 3 months ( P < .01 ) . At baseline , 57 % of patients had extremely heavy bleeding , while only 2 % had that complaint at 36 months . At 36 months , much or moderate improvement in pelvic pain occurred in 83 % of patients , pelvic discomfort in 83 % , and urinary problems in 69 % and 84 % were moderately or very satisfied with their outcome . CONCLUSIONS Over the long-term , UFE using TAGM is effective and safe , with high levels of durable symptom control , improved health-related quality of life and patient satisfaction AIM The purpose of this study was to compare the depth of vascular penetration of non-spherical polyvinyl alcohol ( PVA ) versus trisacryl gelatin microspheres ( MS ) in women undergoing uterine artery embolization ( UAE ) immediately before transabdominal myomectomy . MATERIAL S AND METHODS A total of 17 patients who had been referred for embolization before myomectomy underwent bilateral uterine artery embolization using either 355 - 500 microm PVA ( group A ) or 700 - 900 microm MS ( group B ) . The depth of penetration of the particles was assessed by identifying their presence and location in the resected specimen . RESULTS Of the 17 women enrolled in this study , 10 were in group A and 6 in group B. One woman underwent embolization using both types of particle and was excluded from the analysis . Embolic particles were significantly ( p = 0.048 ) more frequently located within the fibroid ( 4/6 , 67 % ) in Group B than Group A ( 1/10 , 10 % ) . Particles were also identified in the perifibroid tissues in 4/6 ( 67 % ) in Group B and 4/10 ( 40 % ) in Group A , with no statistical difference . There were no procedural complications . CONCLUSION MS particles ( 700 - 900 microm ) penetrate significantly deeper into leiomyomata compared with non-spherical PVA ( 355 - 500 microm ) . MS may therefore confer advantages in UAE , as they may more specifically target the fibroid , allowing an earlier end-point to embolization and minimizing ischaemic damage to normal myometrium and ovaries OBJECTIVE Uterine leiomyoma , or fibroid tumors , are the leading indication for hysterectomy in the United States , but the proportion of women in whom fibroid tumors develop is not known . This study screened for fibroid tumors , independently of clinical symptoms , to estimate the age-specific proportion of black and white women in whom fibroid tumors develop . STUDY DESIGN R and omly selected members of an urban health plan who were 35 to 49 years old participated ( n = 1364 women ) . Medical records and self-report were used to assess fibroid status for those women who were no longer menstruating ( most of whom had had hysterectomies ) . Premenopausal women were screened by ultrasonography . We estimated the age-specific cumulative incidence of fibroid tumors for black and white women . RESULTS Thirty-five percent of premenopausal women had a previous diagnosis of fibroid tumors . Fifty-one percent of the premenopausal women who had no previous diagnosis had ultrasound evidence of fibroid tumors . The estimated cumulative incidence of tumors by age 50 was > 80 % for black women and nearly 70 % for white women . The difference between the age-specific cumulative incidence curves for black and white women was highly significant ( odds ratio , 2.9 ; 95 % CI , 2.5 - 3.4 ; P < .001 ) . CONCLUSION The results of this study suggest that most black and white women in the United States develop uterine fibroid tumors before menopause and that uterine fibroid tumors develop in black women at earlier ages than in white women PURPOSE To compare tris-acryl microspheres and polyvinyl alcohol ( PVA ) microspheres as embolic agents in uterine artery embolization ( UAE ) for uterine leiomyomas in terms of clinical outcome , inflammatory response , and adverse reactions . MATERIAL S AND METHODS A double-blinded r and omized controlled trial was performed , with 27 patients in the tris-acryl microsphere group and 29 in the PVA microsphere group . The primary endpoint was clinical success , defined as a 2-year freedom from subsequent surgery as a result of persistent or deteriorated symptoms . Secondary endpoints included ( i ) posttreatment leiomyoma enlargement , ( ii ) leiomyoma volume reduction at 3 and 9 months , ( iii ) significant residual intratumoral perfusion , ( iv ) increase in inflammatory and stress markers , ( v ) incidence of complications , and ( vi ) duration of hospital stay . RESULTS There was no statistically significant difference between the two groups in patient demographics , clinical presentation , initial tumor findings , change in inflammatory and stress markers after treatment , incidence of complications , and duration of hospital stay . Tris-acryl microspheres were associated with a higher rate of clinical success than PVA microspheres ( 96.3 % [ 26 of 27 ] vs 69 % [ 20 of 29 ] ; P = .012 ) , a lower incidence of posttreatment leiomyoma enlargement ( P = .030 ) , and a lower incidence of significant residual intratumoral perfusion ( P = .030 ) . CONCLUSIONS In the treatment of uterine leiomyomas , UAE with tris-acryl microspheres was associated with a higher clinical success rate , a lower incidence of tumor enlargement , and no significant differences in adverse reactions and inflammatory response compared with the use of PVA microspheres . Tris-acryl microspheres therefore represent the preferred agent for UAE of uterine leiomyomas Objective To evaluate the efficacy of acrylamido polyvinyl alcohol microspheres ( a-PVAM ) as an embolic agent for uterine artery embolization ( UAE ) compared with Tris-acryl gelatin microspheres ( TAGM ) . Design , Setting , Participants Prospect i ve r and omized double-blind noninferiority trial . Conducted at two sites both with regional UAE practice s. Forty-six women with symptomatic leiomyomas . InterventionUAE procedure was performed with either of the two embolic agents . Either 700–900-μm a-PVAM or 500–700-μm TAGM was used . Main Outcome Measures Changes in leiomyoma perfusion , overall uterine volume , and dominant leiomyomas volume measured by contrast-enhanced magnetic resonance imaging at 1 week , 3 months , and 6 months after UAE by a reader blinded to the embolic agent used . Changes in Uterine Fibroid Symptoms and Quality of Life question naire scores were measured at 3 , 6 , and 12 months after UAE . Results Forty-six patients were r and omized and treated under the study protocol ( a-PVAM n = 22 , TAGM n = 24 ) . There were no procedure-related complications . Two patients were excluded from analysis ( one technical failure of the procedure , one withdrawal from study ) . Successful ( > 90 % ) leiomyoma devascularization was observed in 81 % of subjects at 1 week after UAE , 97 % at 3 months after UAE , and 95 % at 6 months after UAE . No significant differences were observed in 14 of 15 outcome measurements , consistent with noninferiority . TAGM was slightly superior to a-PVAM on one comparison ( overall quality of life at 3 months after UAE ) Purpose This study was design ed to compare quality of life ( QoL ) outcomes after uterine artery embolization ( UAE ) or myomectomy . Methods Women with symptomatic fibroids diagnosed by ultrasound who wished to preserve their uterus were r and omized to myomectomy ( n = 81 ) or UAE ( n = 82 ) . Endpoints at 1 year were QoL measured by a vali date d question naire , hospital stay , rates of complications , and need for reintervention . Results UAE patients had shorter hospitalization ( 2 vs. 6 days , p < 0.001 ) . By 1 year postintervention , significant and equal improvements in QoL scores had occurred in both groups ( myomectomy n = 59 ; UAE n = 61 ) . There had been two ( 2.9 % ) major complications among UAE versus 6 ( 8 % ) among myomectomy patients ( not significant ) . By 2 years , among UAE patients ( n = 57 ) there were eight ( 14.0 % ) re interventions for inadequate symptom control compared with one ( 2.7 % ) among myomectomy patients ( n = 37 ) . Half of the women who required hysterectomy had concomitant adenomyosis missed by US . Conclusions UAE and myomectomy both result in significant and equal improvements in QoL. UAE allows a shorter hospital stay and fewer major complications but with a higher rate of reintervention Purpose To report 5-year contrast-enhanced magnetic resonance imaging findings of the REST trial recruits who underwent either uterine artery embolization ( UAE ) or myomectomy . Methods A total of 157 patients were r and omized to UAE or surgery ( hysterectomy or myomectomy ) . Ninety-nine patients who had UAE and eight patients who had myomectomy were analyzed . MRI scans at baseline , 6 months , and 5 years were independently interpreted by two radiologists . Dominant fibroid diameter , uterine volume , total fibroid infa rct ion ( complete 100 % , almost complete 90–99 % , partial < 90 % ) , and new fibroid formation were the main parameters assessed and related to the need for reintervention . Results In the UAE group , mean ± st and ard deviation uterine volume was 670 ± 503 , 422 ± 353 , and 292 ± 287 mL at baseline , 6 months , and 5 years , respectively . Mean dominant fibroid diameter was 7.6 ± 3.0 , 5.8 ± 2.9 , and 5 ± 2.9 cm at baseline , 6 months , and \n Output:\n " }, { "from": "agent", "value": "Compared to polyvinyl alcohol , tris-acryl gelatin microsphere showed a significant benefit in improving the overall quality of life and in reducing uterine volume at three and six months , in reducing overall symptom severity at 6 and 12 months , and furthermore in reducing treatment failure .\nIn addition , tris-acryl gelatin microsphere could significantly reduce leiomyoma volume and decrease < 90 % complete leiomyoma infa rct ion rate at three months .\nThere were no differences in pain severity , other post-procedural symptoms or medication use in the two groups .\nConclusions : A better effect of tris-acryl gelatin microsphere in leiomyoma embolization for patients with symptomatic leiomyoma" } ]

[ { "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 object of this study was to compare the protective action of a new barrier cream ( Excipial Protect ® , Spirig Pharma AG , Egerkingen , Switzerl and ) to its vehicle in the context of h and irritation of apprentice hairdressers caused by repeated shampooing and exposure to hair‐care products . This was a double‐blind cross‐over comparing Excipial Protect ® ( containing aluminium chlorohydrate 5 % as active ingredient ) against its vehicle alone . The efficacy of the creams was evaluated taking into account : ( 1 ) clinical scores by research ers , ( 2 ) biometric measurements , ( 3 ) subjective opinions of the subjects . An analysis of variance was performed considering order of application , degree of atopy , and reported number of shampoos . We observed very little difference in efficacy between the protective cream and its vehicle . The presence , however , of aluminium chlorhydrate in the protective cream was shown to have a positive effect against work‐related irritation . The cosmetic qualities of the creams seemed , to the participants , to be as important as their real protective and hydrating properties , an important factor in compliance issues The purpose of this study was to develop a new model for the induction of chronic irritant contact dermatitis , which would reflect well the conditions of daily practice . Various weak irritant agents were tested for irritating potency on the skin and the sensitivity of transepidermal water loss ( TEWL ) measurements in the detection of early skin changes was also studied . 10 widely used surfactants and 1 solubilizer were applied to the skin of the forearms of healthy volunteers in aqueous solutions of 12.5 millimoles/1 for 45 min twice daily for 3 weeks . The effect on the skin was evaluated daily by means of TEWL measurements and by a visual scoring system . Each solution caused an increase in TEWL value over time due to the cumulative irritating action on the epidermal barrier . This increase in TEWL was different for the various solutions , result ing in different mean TEWL values on the last day of the experiment . Thus , it was possible to rank the agents according to irritating potency . This ranking order was the same in almost every individual and remained constant during the 3 weeks . In comparison with the visual scoring system , the TEWL measurements were more sensitive in the detection of early changes in the skin BACKGROUND Limited information documents the prevention and treatment benefits of a h and care regimen using moisturizer in a controlled manner for employees in typical manufacturing situations . OBJECTIVE The objective was to assess the effectiveness of a comprehensive skin care program including skin conditioning lotion in multiple manufacturing environments where employees are at high risk for skin disease . METHODS A r and omized trial test design with multiple measures , including skin bioengineering measurement techniques , visual grading , and self- assessment question naires , was used to broadly characterize skin condition . RESULTS Comparison of the change in the skin condition of workers using the full h and care regimen with moisturizer versus a control group using a regimen without moisturizer demonstrated significant ( p < .05 ) improvements in multiple measures after 1 to 2 weeks . Corneometer readings consistently showed significant improvement for employees using moisturizer , regardless of their work location . CONCLUSION Improved skin condition result ed from the regular use of an effective skin conditioning h and moisturizer as part of a skin care regimen in work environments in which workers were prone to experiencing occupational irritant contact dermatitis An in vivo method was developed to measure the effectiveness of skin protective creams against 2 dye indicator solutions : methylene blue in water and oil red O in ethanol , representative of model hydrophilic and lipophilic compounds , 3 representative barrier creams commercialized as effective against lipophilic , hydrophilic , or lipophilic and hydrophilic substances were assayed by measurements of the dye in cyanoacrylate strips of protected skin sample s after various application limes . The flexural surfaces of the forearms of 6 normal volunteers ( 3 female and 3 male , mean age 26.8±4.1 years ) were treated . The method was as follows : solutions of 5 % methylene blue in water and 5 % oil red O in ethanol were prepared , and applied to untreated skin and protective‐cream‐pretreated skin with the aid of aluminum occlusive chambers , for 0 h and 4 h , respectively . At the end of the application time , the creams were removed . Consecutive skin surface biopsies ( SSB ) from 1 to 4 strips were taken . The amount of stain in each strip was determined by colorimetry , and the cumulative amount of stain from 1 to 4 strips in each measurement was calculated . The cumulative amount represents the amount of permeation of each solution at each time point , and the efficacy of skin barrier cream . The results showed one formulation at both 0 h and 4 h reduced the amount of permeation of melhylene blue ( p<0.0l ) and oil red O ( p<0.01 ) compared with the control group . Another formulation was protective against the permeation of oil red O ( p < 0.0l ) . but not against methylene blue at 0 h and 4 h ; it was not significantly different at 0 h versus 4 h. The 3rd formulation produced increased cumulative amounts to oil red O at both 0 h and 4 h ( p<0.05 ) ; it also increased permeation amounts to methylene blue ( p<0.05 ) after 4 h. This model appears a facile , rapid and objective early screen to evaluate the efficacy of skin barrier creams in vivo , as well as their individual ingredients A total of 942 workers of 13 dyeing and printing factories in the area of Como ( N. Italy ) were examined in order to detect skin complaints on the h and s and forearms . Of these , 868 were eligible for and consented to participate in a controlled and r and omized experiment aim ed at assessing the efficacy of using barrier creams in practical circumstances . 657 workers underwent all three control examinations arranged over about one year . In the r and omized group for treatment with barrier creams the cumulative incidence of objective skin lesions was significantly lower than in the group in which no particular recommendation of use was made ( 44.5 % versus 54.4 % positive for objective examination in at least one of the three control examinations after recruitment : 95 % confidence limits of the difference between 2%-17 % percentages ; 39.9 % versus 47.0 % in subjects who were negative at the recruitment examination , 59.0 % versus 76.8 % in subjects who were positive at the recruitment examination ) . The use of a hydrocarbon cream was significantly more effective than using a silicone cream ( 95 % confidence limits of the differences of cumulative incidences : -10.9 % + 20.7 % comparing silicone creams with non-treatment ; 2.8%-20.2 % comparing hydrocarbon creams with non-treatment ) The effect on the skin of housewives of using a washing product in the home for all cleaning purpose s under conditions of maximal exposure has been studied . Tests conducted on over 4,000 housewives showed that detergents containing proteolytic enzymes had no greater effect on the skin than conventional detergents , even when the h and skin condition was initially poor . The same was true in a further test on 130 housewives with “ dishpan ” h and s. No adverse reactions attributable specifically to the enzyme products were seen . No eruptions from contact with clothes washed in enzyme products were reported from any of the families involved in these tests Objective . The objective of this controlled intervention study was to quantify the efficacy of skin protection ( SP ) measures and ultraviolet B ( UVB ) hardening in the prevention of h and dermatitis in bakers ' apprentices . Method . SP measures were compared against UVB hardening in a controlled clinical trial of 94 apprentices . The apprentices were assigned to the intervention arms class-wise . Bakers ' apprentices involved in a previous follow-up study served as additional controls representing no intervention . The apprentices were interviewed and examined in a st and ardised way at the beginning of the training and at 4 monthly follow-ups . Transepidermal water loss ( TEWL ) was measured at the back of the h and s. Results . Demographic profile and atopy criteria were equally distributed in the two intervention arms and the control group . Point prevalence of h and dermatitis after 6 months was highest in the controls ( 29.1 % ) followed by the UVB ( 19.4 % ) and the SP group ( 13.3 % ) . UVB hardening and SP measures reduced h and dermatitis prevalence by 9.7 % ( 95%CI : –8.5 to 28.1 ) and 15.7 % ( 95%CI : –2.4 to 33.9 ) , respectively . Application of SP measures reduced the odds ratios ( ORs ) for h and dermatitis 0.8-fold ( 95%CI : 0.17–3.70 ) and 0.33-fold ( 95%CI : 0.09–1.23 ) compared with the UVB group and the controls , respectively . These clinical trends were confirmed by statistically significant differences in TEWL values . TEWL values were consistently higher in the UVB group than in the SP group ( P=0.002 ) . Conclusions . This study provided evidence , based on significant differences in TEWL levels , that general SP measures may be more effective than UV light hardening of the skin , which in turn was more effective than no intervention . This trend was supported by the frequency of development of clinical h and dermatitis , although differences did not reach statistical significance . A multi-centre trial is recommended to confirm the efficacy of SP measures in a larger r and omised study Aims : To evaluate the effect of implementation of an evidence based skin care programme for wet work employees as part of an occupational health and safety management system . Methods : 375 wet work employees were included in a prospect i ve r and omised controlled trial , allocated to either intervention ( n = 207 ) or control ( n = 168 ) . The intervention group was exposed to a skin care programme during the five month study period . The intervention included an educational programme for a group of frontline employees , who underwent formalised training , and subsequently introduced the information to their colleagues . As part of the intervention a skin care policy including written instructions was established at each workplace . Both groups answered a test quiz , completed question naires on behaviour and symptoms , and underwent clinical examination of their h and s before and after the five month period . Results : No difference between the intervention and the control group was found at baseline with respect to clinical symptoms or behaviour . Evaluation after the five months of intervention revealed a significantly higher information level on skin care in the intervention group compared to the control group , a significant change in behaviour in the intervention group but not in the control group , and significantly less skin symptoms as evaluated clinical ly in the intervention group but not in the control group . No significant difference was found for self reported skin problems . Conclusions : The intervention was successful with respect to information level ( knowledge ) , behaviour , and clinical symptoms . Implementation of a skin care programme as part of an occupational health and safety management system is recommended as a prophylactic measure for employees in wet occupations Objectives : The objective of the present implementation study is to document how an intervention to reduce work-related skin problems by means of implementing an evidence -based skin protection programme in six gut-cleaning departments in swine slaughterhouses was understood , accepted and carried out . The association between the degree of implementation and the reduction of work-related skin problems in each department is examined . The intervention included a top-down strategy with establishment of a management system focusing on skin risks and a bottom-up strategy with participation of a selected group of shop floor workers and the safety representative , as change agents , as well as an empowerment-based educational programme , where the middle management and representatives from the top management also participated . Methods : The study design was a r and omized controlled intervention study with a 1-year study period . The outcome of the intervention was evaluated by telephone interviews . Data on the implementation process consisted of self-administered question naires , focus interviews and compiled written material s. Four indexes referring to the management system and the change agents ’ intervention activities were constructed . Finally , the Pearson correlation coefficient was used to test the correlation between the degree of implementation and the eczema frequency at 1-year follow-up . Results : There was a statistically significant association ( p < 0.05 ) between both the index for the combined implementation method and the eczema frequency after 1 year of intervention , and between the activities of the change agents and the eczema frequency . In contrast to this there was only a weak association between the establishment of a formal management system alone and the outcome . Conclusion : The study evidence s that a combination of a top-down and a bottom-up implementation method is effective to reduce work-related skin problems , and that the process of implementation is a significant determinant of the overall results The effect of three industrial h and cleansers on transepidermal water loss ( TWL ) was evaluated in groups of healthy volunteers . After 2 weeks , subjects using Baracaide averaged 47 % less TWL than those using Swarfega und 35 % less than with Go‐Jo . In a second study in printers , the use of Baracaide decreased TWL by 20 % after 2 weeks . Because it contains no volatile solvents , Baracaide may be less injurious to the barrier layer OBJECTIVE To examine the impact of introduction of an alcohol-based h and rub on h and hygiene knowledge and compliance and h and colonization of healthcare workers ( HCWs ) in a long-term-care facility ( LTCF ) . METHODS Two floors of an LTCF participated . Ward A used the h and rub as an adjunct to soap and water ; ward B was the control . HCWs ' h and s were cultured using the bag-broth technique for Staphylococcus aureus , gram-negative bacilli ( GNB ) , C and ida , and vancomycin-resistant enterococci ( VRE ) . HCWs completed a question naire at baseline and after an educational intervention and introduction of rub . RESULTS H and \n Output:\n " }, { "from": "agent", "value": "However , this risk reduction may not be clinical ly important .\nThe investigated interventions to prevent OIHD probably cause few or no serious adverse effects .\nAUTHORS ' CONCLUSIONS Moisturisers used alone or in combination with barrier creams may result in a clinical ly important protective effect , either in the long- or short-term , for the primary prevention of OIHD .\nBarrier creams alone may have slight protective effect , but this does not appear to be clinical ly important .\nFor skin protection education , the results varied substantially across the trials , the effect was imprecise , and the pooled risk reduction was not large enough to be clinical ly important .\nThe very low quality of the evidence means that we are unsure as to whether skin protection education reduces the risk of developing OIHD .\nThe interventions probably cause few or no serious adverse effects .\nWe conclude that at present there is insufficient evidence to confidently assess the effectiveness of interventions used in the primary prevention of OIHD .\nThis does not necessarily mean that current measures are ineffective ." } ]

[ { "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 Substantial evidence exists that positive therapy outcomes are related to the therapist – client working alliance . Objectives To report two studies that examined ( 1 ) the quality of the working alliance in online cognitive behavior therapy ( CBT ) , with minimal therapist contact , for anxiety disorders in youth , and ( 2 ) the role of working alliance and compliance in predicting treatment outcome . Methods Study 1 participants were 73 adolescents aged 12 to 18 years who met diagnostic criteria for an anxiety disorder , plus one or more of their parents . Participants were r and omly assigned to clinic or online delivery of CBT , with working alliance being assessed for youth and parents after session 3 . Study 2 participants were 132 children and adolescents aged 7 to 18 years who met diagnostic criteria for an anxiety disorder , plus one or more of their parents . Youths and parents participated in a minimally therapist-assisted online CBT program supported by brief , weekly emails and a single , short phone call . Results Study 1 revealed a strong working alliance for both online and clinic CBT , with no significant difference in working alliance between conditions for adolescents ( F 1,73 = 0.44 , P = .51 , ηp 2 = 0.006 , Cohen d = 0.15 ) . Parents also reported high working alliance in both conditions , although a slight but significantly higher working alliance in clinic-based therapy ( F 1,70 = 6.76 , P = .01 , ηp 2 = 0.09 , Cohen d = 0.64 ) . Study 2 showed a significant and substantial decrease in anxiety symptoms following online therapy ( P < .001 for all outcome measures ) . Adolescents improved significantly more in overall functioning when working alliance ( beta = .22 , t 79 = 2.21 , P = .03 ) and therapy compliance ( beta = .22 , t 84 = 2.22 , P = .03 ) were higher , with working alliance also predicting compliance ( beta = .38 , F 1,80 = 13.10 , P = .01 ) . No such relationships were evident among younger children . Conclusions Working alliance is important in determining clinical outcome for online treatment for anxiety among adolescents , with minimal therapist assistance , although this was not the case for younger children . Trial Registration Australian New Zeal and Clinical Trials Registry : ACTRN12611000900910 ; http://www.anzctr.org.au/trial_view.aspx?ID=343375 ( Archived by WebCite at http://www.webcitation.org/674C4N3JJ INTRODUCTION Although depression can be treated effectively with Cognitive Behaviour Therapy ( CBT ) , only a small percentage of Chinese Australians access evidence -based treatment due to practical and cultural barriers . The present study examined the efficacy and acceptability of an Internet delivered CBT ( iCBT ) program to treat Chinese Australians with depression . METHODS The Chinese depression iCBT program ( the Brighten Your Mood Program ) is a culturally adapted version of the clinical ly efficacious Sadness iCBT Program . Fifty-five Chinese Australians with depression were r and omly allocated to either an immediate treatment group or to a waitlist control group . Treatment consisted of an 8 week program with 6 CBT online educational lessons , homework assignments , additional re sources presented in Chinese and English , and weekly telephone support with M and arin/Cantonese-speaking support personnel . An intention-to-treat model was used for data analyses . RESULTS Seventeen of twenty-five ( 68 % ) treatment group participants completed all lessons within the timeframe . Compared to controls , treatment group participants reported significantly reduced symptoms of depression on the Chinese versions of the Beck Depression Inventory ( CBDI ) and Patient Health Question naire-9 item ( CB-PHQ-9 ) . The within- and between-group effect sizes ( Cohen 's d ) were 1.41 and 0.93 on the CBDI , and 0.90 and 0.50 on the CB-PHQ-9 , respectively . Participants rated the procedure as acceptable , and gains were sustained at three-month follow-up . LIMITATIONS The study included several sub clinical participants and some measures that have not been previously vali date d with Chinese Australians . CONCLUSIONS Results provide preliminary support for the efficacy and acceptability of an iCBT program at reducing symptoms of depression in Chinese Australians Background : Depression is an important health issue amongst older adults . Internet-delivered cognitive behaviour therapy ( iCBT ) may help to reduce barriers and improve access to treatment , but few studies have examined its use with older adults . The present study evaluated the efficacy , acceptability and feasibility of a brief iCBT program , the Managing Your Mood Program , to treat depression amongst adults aged 60 years and older . Method : Using an open trial design , 20 participants with elevated symptoms of depression ( Patient Health Question naire 9-item ( PHQ-9 ) total scores ≥ 10 ) received access to five educational lessons and homework summaries , additional re sources , a moderated discussion forum and weekly telephone or email contact from a clinical psychologist . Eighty percent of the sample met diagnostic criteria for a major depressive episode at pre-treatment . Results : Completion rates and response rates were high , with 16/20 participants completing the five lessons within the 8 weeks , and post-treatment and 3-month follow-up data being collected from 17/20 participants . Participants improved significantly on the PHQ-9 and Geriatric Depression Scale ( GDS ) , with large within-group effect sizes ( Cohen ’s d ) at follow-up of 1.41 and 2.04 , respectively . The clinician spent a mean time of 73.75 minutes ( SD = 36.10 minutes ) contacting participants within the trial and the program was rated as highly acceptable by participants . Conclusions : The results are encouraging and support the potential value of iCBT in the treatment of depressive symptoms amongst older adults Background Indigenous Australian youth ( aged 15 to 34 ) have up to four times the risk of suicide compared with their non-Indigenous counterparts . Barriers to help-seeking include shame , feared loss of autonomy and negative attitudes towards healthcare providers . The use of mobile devices and apps continues to rise amongst young people , thus presenting opportunities to utilize these aids in overcoming help-seeking barriers . Apps have been shown to assist in several health-related areas , including weight loss and smoking cessation , although no apps have as yet been evaluated for suicide prevention . Moreover , there is a lack of research that scientifically evaluates suicide prevention interventions within Indigenous communities . Methods / Design In this study , a recently developed self-help app will be evaluated in a r and omized controlled trial . The intervention is based on acceptance and commitment therapy and mindfulness-based cognitive behavioural therapy . It is aim ed at participants who have suicidal thoughts but who are not actively suicidal . In total , 150 participants will be r and omly allocated to the intervention-condition ( N = 75 ) or to the wait-list control condition ( N = 75 ) . Question naires will be completed at baseline , post-test and 6 weeks follow-up . The primary outcome measure is a reduction in frequency and intensity of suicidal thoughts . Secondary outcome measures are the reduction of depression , anxiety and impulsivity . Discussion This study is the first to evaluate the effectiveness of a self-help app for suicidal thoughts amongst young Indigenous people . Several limitations and strengths of the design are discussed . Trial registration Australian New Zeal and Clinical Trials Registry ( ANZCTR ) : ACTRN12613000104752 Fifty-five people with panic disorder ( PD ) were r and omised to internet-based cognitive behavioural panic treatment ( CBT ) ( with email contact ) , therapist-assisted CBT manual or information-only control ( both with telephone contact ) . Both CBT treatments were more effective in reducing PD symptomatology , panic-related cognition , negative affect , and number of GP visits and improving physical health ratings . Internet treatment was more effective than CBT manual in reducing clinician-rated agoraphobia and number of GP visits at post- assessment . At follow-up , these effects were maintained for both CBT groups , with internet CBT better at improving physical health ratings and reducing GP visits . This study provides support for the efficacy of internet-based CBT This study was an open trial evaluation of a 10-week therapist-assisted cognitive behavior therapy ( CBT ) internet intervention ( PTSD Online ) undertaken with people with a primary clinical diagnosis of posttraumatic stress disorder ( PTSD ) ( n=22 ) at pre- assessment . Participants were re-assessed at post- assessment and 3-month follow-up . Significant improvements on PTSD severity ratings and related PTSD symptomatology were observed at post- assessment and maintained at 3-month follow-up . At post- assessment , 69.2 % of the sample showed clinical ly significant improvement and 77 % of the sample at follow-up assessment . Non-significant , yet improved , change was observed on all other general psychological measures . Overall , treatment satisfaction was good ( 69 % ) , participant therapeutic alliance ratings were high ( 87.5 % ) , and the average total therapist time required was 194.5 min . PTSD Online appears to be an efficacious treatment option for people with PTSD that can be provided entirely remotely , with far less therapist time than traditional face-to-face treatment , and without compromising therapeutic alliance BACKGROUND Subthreshold depression is common , impairs functioning and increases the risk of major depression . Improving self-help coping strategies could help subthreshold depression and prevent major depression . AIMS To test the effectiveness of an automated email-based campaign promoting self-help behaviours . METHOD A r and omised controlled trial was conducted through the website : www.moodmemos.com . Participants received automated emails twice weekly for 6 weeks containing advice about self-help strategies . Emails containing general information about depression served as a control . The principal outcome was depression symptom level on the nine-item Patient Health Question naire ( PHQ-9 ) ( trial registration : ACTRN12609000925246 ) . RESULTS The study recruited 1326 adults with subthreshold depression . There was a small significant difference in depression symptoms at post-intervention , favouring the active group ( d = 0.17 , 95 % CI 0.01 - 0.34 ) . There was a lower , although non-significant , risk of major depression in the active group ( number needed to treat ( NNT ) 25 , 95 % CI 11 to ∞ to NNT(harm ) 57 ) . CONCLUSIONS Emails promoting self-help strategies were beneficial . Internet delivery of self-help messages affords a low-cost , easily disseminated and highly automated approach for indicated prevention of depression This study compared Panic Online ( PO ) , an internet-based CBT intervention , to best- practice face-to-face CBT for people with panic disorder with or without agoraphobia . Eighty-six people with a primary diagnosis of panic disorder were recruited from Victoria , Australia . Participants were r and omly assigned to either PO ( n=46 ) or best practice face-to-face CBT ( n=40 ) . Effects of the internet-based CBT program were found to be comparable to those of face-to-face CBT . Both interventions produced significant reductions in panic disorder and agoraphobia clinician severity ratings , self reported panic disorder severity and panic attack frequency , measures of depression , anxiety , stress and panic related cognitions , and displayed improvements in quality of life . Participants rated both treatment conditions as equally credible and satisfying . Participants in the face-to-face CBT treatment group cited higher enjoyment with communicating with their therapist . Consistent with this , therapists ' ratings for compliance to treatment and underst and ing of the CBT material was higher in the face-to-face CBT treatment group . PO required significantly less therapist time than the face-to-face CBT condition Background There have been no previous studies of the variables that predict adherence to online depression and anxiety intervention programs among adolescents . However , research of traditionally delivered intervention programs for a variety of health conditions in adolescence suggests that health knowledge , type and level of symptomatology , race , socioeconomic status , treatment setting , and support may predict adherence . Objective The aim was to compare adherence rates and identify the predictors of adherence to a cognitive behavior therapy website in two adolescent sample s that were offered the program in different setting s and under different conditions of support . Methods The first adolescent sample consisted of 1000 school students who completed the MoodGYM program in a classroom setting over five weeks as part of a r and omized controlled trial . The second sample consisted of 7207 adolescents who accessed the MoodGYM program spontaneously and directly through the open access URL . All users completed a brief survey before the start of the program that measured background characteristics , depression history , symptoms of depression and anxiety , and dysfunctional thinking . Results Adolescents in the school-based sample completed significantly more online exercises ( mean = 9.38 , SD = 6.84 ) than adolescents in the open access community sample ( mean = 3.10 , SD = 3.85 ; t 1088.62 = −28.39 , P < .001 ) . A multiple linear regression revealed that school-based setting ( P < .001 ) and female gender ( P < .001 ) were predictive of greater adherence , as were living in a rural area ( P < .001 ) and \n Output:\n " }, { "from": "agent", "value": "Studies indicate that e-mental health services are predominantly used by females , and those who are more educated and socioeconomically advantaged .\nStudies examining consumer preferences found a preference for face-to-face therapy over e-therapies , but not an aversion to e-therapy .\nContent relevant to governance was predominantly related to the organizational dimensions of e-mental health services , followed by implication s for community education .\nFinancing and payment for e-services and governance of the information communication technology were least commonly discussed ." } ]

[ { "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 : One of the main causes of stress in the lives of people is their jobs . Occupational stress is causing a wide range of significant issues in health and community services . Nursing is the most stressful profession in the health services . Massage therapy is one way of coping with stress . This study was conducted to determine the effect of massage therapy on stress in nurses . Material s and Methods : This study was a clinical trial on 66 male and female nurses working in intensive care units ( dialysis , ICU , and CCU ) of Isfahan University of Medical Sciences , Iran , in 2013 . Participants were selected according to the aims and inclusion criteria of the study . Then , they were r and omly divided into experimental and control groups . The Occupational Stress Inventory ( OSI ) ( Osipow and Spokane , 1987 ) was completed by participants of the two groups before , immediately after , and 2 weeks after the intervention . General Swedish massage was performed on participants of the experimental group for 25 min in each session , twice a week for 4 weeks . Data were analyzed by descriptive and inferential statistics [ Chi-square , t-test , and repeated measures analysis of variance ( ANOVA ) ] using SPSS software . Results : Results showed that the difference in overall mean occupation stress scores between experimental and control groups 2 weeks after the intervention was significant ( P < 0.001 ) . Conclusions : According to the results , it is recommended that massage , as a valuable noninvasive method , be used for nurses in intensive care units to reduce their stress , promote mental health , and prevent the decrease in quality of nursing work life Background Cardiac sonographers frequently have work-related muscular discomfort . We aim ed to assess the feasibility of having sonographers receive massages during working hours in an area adjacent to an echocardiography laboratory and to assess relief of discomfort with use of the massages with or without stretching exercises . Methods A group of 45 full-time sonographers was r and omly assigned to receive weekly 30-minute massage sessions , massages plus stretching exercises to be performed twice a day , or no intervention . Outcome measures were scores of the Quick DASH instrument and its associated work module at baseline and at 10 weeks of intervention . Data were analyzed with st and ard descriptive statistics and the separation test for early-phase comparative trials . Results Forty-four participants completed the study : 15 in the control group , 14 in the massage group , and 15 in the massage plus stretches group . Some improvement was seen in work-related discomfort by the Quick DASH scores and work module scores in the 2 intervention groups . The separation test showed separation in favor of the 2 interventions . Conclusion On the basis of the results of this pilot study , larger trials are warranted to evaluate the effect of massages with or without stretching on work-related discomfort in cardiac sonographers . Trial Registration NCT00975026 Clinical Objective . Stress-reducing therapies help maintain cognitive performance during stress . Aromatherapy is popular for stress reduction , but its effectiveness and mechanism are unclear . This study examined stress-reducing effects of aromatherapy on cognitive function using the go/no-go ( GNG ) task performance and event related potentials ( ERP ) components sensitive to stress . The study also assessed the importance of expectancy in aromatherapy actions . Methods . 81 adults were r and omized to 3 aroma groups ( active experimental , detectable , and undetectable placebo ) and 2 prime subgroups ( prime suggesting stress-reducing aroma effects or no-prime ) . GNG performance , ERPs , subjective expected aroma effects , and stress ratings were assessed at baseline and poststress . Results . No specific aroma effects on stress or cognition were observed . However , regardless of experienced aroma , people receiving a prime displayed faster poststress median reaction times than those receiving no prime . A significant interaction for N200 amplitude indicated divergent ERP patterns between baseline and poststress for go and no-go stimuli depending on the prime subgroup . Furthermore , trends for beneficial prime effects were shown on poststress no-go N200/P300 latencies and N200 amplitude . Conclusion . While there were no aroma-specific effects on stress or cognition , these results highlight the role of expectancy for poststress response inhibition and attention BACKGROUND Previous research has identified international and cultural differences in nurses ' workplace stress and coping responses . We hypothesised an association between problem-focused coping and improved health , emotion-focused coping with reduced health , and more frequent workplace stress with reduced health . OBJECTIVES Test the above hypotheses with Australian and New Zeal and nurses , and compare Australian and New Zeal and nurses ' experience of workplace stress , coping and health status . PARTICIPANTS AND SETTING S Three hundred and twenty-eight New South Wales ( NSW ) and 190 New Zeal and ( NZ ) volunteer acute care hospital nurses ( response rate 41 % ) from r and omly sample d nurses . DESIGN AND METHOD Postal survey consisting of a demographic question naire , the Nursing Stress Scale , the WAYS of Coping Question naire and the SF-36 Health Survey Version 2 . RESULTS Consistent with hypotheses , more frequent workplace stress predicted lower physical and mental health . Problem-focused coping was associated with better mental health . Emotion-focused coping was associated with reduced mental health . Contrary to hypotheses , coping styles did not predict physical health . NSW and NZ scored effectively the same on sources of workplace stress , stress coping methods , and physical and mental health when controlling for relevant variables . CONCLUSIONS Results suggest mental health benefits for nurses who use problem-solving to cope with stress by addressing the external source of the stress , rather than emotion-focused coping in which nurses try to control or manage their internal response to stress . Cultural similarities and similar hospital environments could account for equivalent findings for NSW and NZ OBJECTIVE The present study was conducted to determine the effect of massage on post-cesarean pain and anxiety . METHODS The present single-blind clinical trial was conducted on 156 primiparous women undergone elective cesarean section . The participants were r and omly divided into three groups , including a h and and foot massage group , a foot massage group and a control group ( n = 52 per group ) . The patients ' intensity of pain , vital signs and anxiety level were measured before , immediately after and 90 min after the massage . RESULTS A significant reduction was observed in the intensity of pain immediately and 90 min after massage ( P < 0.001 ) . Moreover , changes in some of the physiological parameters , including blood pressure and respiration rate , were significant after massage ( P < 0.001 ) ; however , this change was not significant for pulse rate . A significant reduction was also observed in the level of anxiety ( P < 0.001 ) and a significant increase in the frequency of breastfeeding ( P < 0.001 ) after massage . CONCLUSION As an effective nursing intervention presenting no side-effects , h and and foot massage can be helpful in the management of postoperative pain and stress BACKGROUND While massage has been removed from nursing curricula , studies have reported massage as safe and effective for stress reduction , relaxation , pain relief , fatigue , and quality of life . OBJECTIVE To compare the efficacy of two intensities of touch administered during two seated massages on the attitudes of nursing students toward touch for their self-care and patient care . PARTICIPANTS Nursing students who volunteered gave institutional review board-approved written informed consent to undergo massage by a licensed massage therapist . SETTING S/LOCATION A private room adjacent to the nursing lab in a school of nursing . INTERVENTION Brief seated massages of differing intensities . Each participant received low-intensity and high-intensity touch in a two-block , r and omized order , within-subjects design . Linear mixed models nested within subject and r and om intercept analyses were used to test hypotheses in this two-treatment , two-sequence , two-period crossover design . OUTCOME MEASURES Health question naires/visual analogue scales pertaining to physical/affective/ and attitudinal status were completed before and after each massage . RESULTS Twenty-nine participants ( 93 % female , 83 % single ) completed the study . Before massage , the optimal intensity of touch anticipated for self-comfort was 6.6 ( 0=no pressure;10=most intense pressure imaginable ) . The mean touch intensities were 6.7 for high-intensity massage and 0.5 for low-intensity ( p<0.001 ) . The overall percentage differences ( feeling better or worse ) following massage were as follows : low intensity , 37.5 % better ; high intensity , 62.7 % better ( p<0.001 ) . Significantly more improvement was reported for energy , pain , stress , and feeling physically uptight after high-intensity compared with low-intensity ( p<0.03 ) . Participants were more likely to both receive touch for self-care and provide touch for patient care after experiencing high- versus low-intensity massage ( p<0.01 ) . CONCLUSIONS High-intensity seated massage was more efficacious than low-intensity massage and positively influenced nursing student attitudes toward the inclusion of massage in self-care/patient care . The role of touch for self-care/patient care in the nursing curricula merits reconsideration AIMS AND OBJECTIVES This research aim ed to evaluate the use of aromatherapy massage and music as an intervention to cope with the occupational stress and anxiety that emergency department staff experience . The study also aim ed to compare any differences in results between a summer and winter 12-week massage plan . BACKGROUND Emergency nurses are subjected to significant stressors during their work and it is known that workloads and patient dem and s influence the role stress has on nurses . The perception that winter months are busier for emergency departments has long been held and there is some evidence that people with cardiac and respiratory dysfunction do present more frequently in the winter months . Massage has been found to decrease staff anxiety . DESIGN The study used a one-group pre-test , post-test quasi-experimental design with r and om assignment . METHOD Staff occupational stress was assessed pre- and post- 12 weeks of aromatherapy massage with music and anxiety was measured pre and post each massage session . Sick leave was also measured . Comparisons of summer and winter data were undertaken . RESULTS A total of 365 massages were given over two 12-week periods , one during summer and the other during winter . Analysis identified that aromatherapy massage with music significantly reduced anxiety for both seasonal periods . Premassage anxiety was significantly higher in winter than summer . No differences in sick leave and workload were found . There was no difference in the occupational stress levels of nurses following the two 12-week periods of massage . CONCLUSION Emergency nurses were significantly more anxious in winter than summer but this can not be attributed to increased sick leave or workloads . Aromatherapy massage with music significantly reduced emergency nurses ' anxiety . RELEVANCE TO CLINICAL PRACTICE High levels of anxiety and stress can be detrimental to the physical and emotional health of emergency nurses and the provision of a support mechanism such as on-site massage as an effective strategy should be considered OBJECTIVE To investigate the effectiveness of massage therapy in reducing physiological and psychological indicators of stress in nurses employed in an acute care hospital . DESIGN R and omised controlled trial . SETTING Acute care hospital in Queensl and . SUBJECTS Sixty nurses were recruited to the five week study and r and omly assigned to two groups . INTERVENTION A 15 minute back massage once a week . The control group did not receive any therapy . MAIN OUTCOME MEASURES Demographic information , a life events question naire and a brief medical history of all participants was completed at enrolment . Physiological stress was measured at weeks one , three and five by urinary cortisol and blood pressure readings . Psychological stress levels were measured at weeks one and five with the State-Trait Anxiety Inventory ( STAI ) . RESULTS Differences in the change in urinary cortisol and blood pressure between the two groups did not reach statistical significance . However , STAI scores decreased over the five weeks for those participants who received a weekly massage . The STAI scores of the control group increased over the five week period . These differences between the groups were statistically significant . CONCLUSION The results of this study suggest that massage therapy is a beneficial tool for the health of nurses as it may reduce psychological stress levels . It is recommended that further large studies be conducted to measure the symptoms of stress rather than the physiological signs of stress in nurses The goal of this study is to examine the effects of aromatherapy massage on sleep quality of nurses with monthly rotating night shifts . Subjects were enrolled at a medical center in central Taiwan with overall score ≥ 5 of Pittsburgh Sleep Quality Index ( PSQI ) and r and omly assigned to the treatment or control groups . They were vali date d by pretests during their first graveyard shift in the trial period and the sleep quality information was collected by using the PSQI and sleep detectors . During the second graveyard shift , the treatment group received aromatherapy massage and the control group rested in the same aromatherapy room after work . All subjects filled out the PSQI surveys and the sleep quality information was collected during massage or resting and the following night . We found that the total PSQI was significantly decreased in the treatment group following the aromatherapy massage . Specifically , the components such as subjective sleep quality , sleep disturbance , and daytime dysfunction were significantly decreased . However , there were no significant changes of average PSQI scores between the two groups before and after intervention . Taken together , our study suggested that aromatherapy massage could improve sleep quality of nurses with monthly rotating night shift OBJECTIVES Aromatherapy massage is commonly used for the stress management of healthy individuals , and also has been often employed as a thera \n Output:\n " }, { "from": "agent", "value": "Most studies reported that aromatherapy and massage exert a beneficial effect on the stress of nurses .\nThis review revealed that the evidence does not sufficiently prove that aromatherapy , massage and aromatherapy massage are effective for reducing job-related stress of nurses ." } ]

[ { "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 one-third of community-dwelling older adults fall each year , and approximately 10 % have falls requiring medical services . Among other factors , research studies have linked certain medications with an increased risk of falls . Objective The aim of this study was to examine the risk of falls relative to use patterns among new and continuing falls-related drug ( FRD ) users . Methods A 10 % r and om sample , insured in AARP ® Medicare Supplement and AARP Medicare Part D Rx plans , was utilized to define new and continuing FRD users . New users had a 12-month pre-period without FRD use , whereas continuing users had at least one FRD in the pre-period . Both groups had 12-month follow-up after initiating or continuing FRD use . Characteristics associated with the risk of falls for new and continuing users were determined using multivariate logistic regression models . Results Among insureds , 44 % used at least one of the FRD classes . Of these , 29 % were new users ( N = 35,340 ) and 71 % were continuing users ( N = 121,488 ) . Fall rates for the two subgroups were similar at 7 and 8 % , respectively . Characteristics associated with the risk of falls were previous injurious fall , use of two or more classes of FRDs , older age , poorer health , and being female . New users were at higher risk than continuing users . Conclusion New users of FRDs were at highest risk of falls , and continuing users were at increased risk , especially with higher numbers of FRD classes . Both groups could benefit from falls awareness and prevention programs BACKGROUND Insomnia is the most common of all sleep complaints and is under- research ed . The current treatments of choice are conventional hypnotics agents , but these have potential for serious adverse reactions . Uncontrolled and anecdotal evidence suggests that lavender oil is an effective treatment for insomnia , but this has not been formally investigated . OBJECTIVES The aims of this study were to evaluate the proposed trial methodology and the efficacy of Lav and ula augustifolia ( lavender ) on insomnia . INTERVENTIONS INTERVENTIONS consisted of Lav and ula augustifolia ( treatment ) and sweet almond oil as placebo/control . The aroma was supplied via an Aromastream device ( Tisser and Aromatherapy , Sussex , UK ) . DESIGN This was a pilot study with r and omized , single-blind , cross-over design ( baseline , two treatment periods , and a washout period , each of 1 week duration ) . SUBJECTS AND SETTING Volunteers with defined insomnia treated on a domiciliary basis participated in the study . OUTCOME MEASURES Outcomes were assessed with the following : Pittsburgh Sleep Quality Index ( PSQI ) indicating insomnia ( score > 5 at entry ) ; Borkovec and Nau ( B&N ) Question naire evaluating treatment credibility ; and Holistic Complementary and Alternative Medicine Question naire ( HCAMQ ) assessing attitudes to CAM and health beliefs . RESULTS Ten ( 10 ) volunteers ( 5 male and 5 female ) were entered and completed the 4 week study . Lavender created an improvement of -2.5 points in PSQI ( p = 0.07 , 95 % CI - 4.95 to - 0.4 ) . Each intervention was equally credible and belief in CAM did not predict outcome . Women and younger volunteers with a milder insomnia improved more than others . No period or carry-over effect was observed . CONCLUSION The methodology for this pilot study appeared to be appropriate . Outcomes favor lavender , and a larger trial is required to draw definitive conclusions Background In recent years , the number of prescriptions for sedative drugs has increased significantly , as has their long-term use . Moreover , sedative use is frequently initiated during hospital stays . Objectives This study aim ed to describe new prescriptions of sedative drugs during hospital stays and evaluate their maintenance as discharge medication . Methods This observational prospect i ve study took place in an internal medicine ward of a Swiss hospital over a period of 3 months in 2014 . Demographic ( age , sex , diagnosis , comorbidities ) and medication data [ long-term use of sedative drugs , new regular or pro re nata ( ‘ as needed ’ ) prescriptions of sedative drugs , drug-related problems ] were collected . Sedative medications included : benzodiazepines , Z-drugs , antihistamines , antidepressants , neuroleptics , herbal drugs , and clomethiazole . McNemar ’s test was used for comparison . Results Of 290 patients included , 212 ( 73 % ) were over 65 years old and 169 ( 58 % ) were women ; 34 % ( n = 98 ) were using sedative drugs long term before their hospital stay , and 44 % ( n = 128 ) had a prescription for sedative drugs at discharge — a 10 % increase ( p < 0.05 ) . Sedative drugs were newly prescribed to 37 % ( n = 108 ) of patients during their stay . Among these , 37 % ( n = 40 ) received a repeat prescription at discharge . Over half of the sedative drugs were prescribed within 24 h of admission . Drug-related problems were detected in 76 % of new prescriptions , of which 90 % were drug – drug interactions . Conclusion This study showed that hospital stays increased the proportion of patients who were prescribed a sedative drug at discharge by 10 % ( absolute increase ) . These prescriptions may generate long-term use and expose patients to drug-related problems . Promoting alternative approaches for managing insomnia are recommended This study was performed to investigate the anxiolytic efficacy of silexan , a new oral lavender oil capsule preparation , in comparison to placebo in primary care . In 27 general and psychiatric practice s 221 adults suffering from anxiety disorder not otherwise specified ( Diagnostic and Statistical Manual of Mental disorders – IV 300.00 or International Statistical Classification of Diseases and Related Health Problems , Tenth revision F41.9 ) were r and omized to 80 mg/day of a defined , orally administered preparation from Lav and ula species or placebo for 10 weeks with visits every 2 weeks . A Hamilton Anxiety Scale ( HAMA ) total score ≥18 and a total score > 5 for the Pittsburgh Sleep Quality Index ( PSQI ) were required . The primary outcome measures were HAMA and PSQI total score decrease between baseline and week 10 . Secondary efficacy measures included the Clinical Global Impressions scale , the Zung Self-rating Anxiety Scale , and the SF–36 Health Survey Question naire . Patients treated with silexan showed a total score decrease by 16.0±8.3 points ( mean±SD , 59.3 % ) for the HAMA and by 5.5±4.4 points ( 44.7 % ) for the PSQI compared to 9.5±9.1 ( 35.4 % ) and 3.8±4.1 points ( 30.9 % ) in the placebo group ( P<0.01 one-sided , intention to treat ) . Silexan was superior to placebo regarding the percentage of responders ( 76.9 vs. 49.1 % , P<0.001 ) and remitters ( 60.6 vs. 42.6 % , P=0.009 ) . Lav and ula oil preparation had a significant beneficial influence on quality and duration of sleep and improved general mental and physical health without causing any unwanted sedative or other drug specific effects . Lav and ula oil preparation silexan is both efficacious and safe for the relief of anxiety disorder not otherwise specified . It has a clinical ly meaningful anxiolytic effect and alleviates anxiety related disturbed sleep \n Output:\n " }, { "from": "agent", "value": "Conclusions : A comprehensive search of the literature uncovered no evidence related to the effectiveness of Silexan compared to inhaled lavender essential oil aromatherapy for sleep latency , sleep duration , sleep quality , disturbed sleep or anxiety in adult 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: AIM The purpose of the present study is to evaluate the healing of periapical lesions of teeth with positive and negative canal cultures at the time of obturation , and to evaluate the periapical healing of teeth treated in one visit ( without ) or in two visits with an interappointment dressing of calcium hydroxide . METHODOLOGY Thirty-nine patients received root-canal treatment . In the first visit , teeth were instrumented , and 18 of these teeth were filled ( after microbiological sampling ) with calcium hydroxide in sterile saline . The other 21 teeth were obturated with gutta-percha and AH-26 sealer after microbiological sampling . Four weeks later , the teeth with calcium hydroxide were accessed again and after microbiological sampling they were obturated with gutta-percha and AH-26 sealer . Healing of periapical radiolucency was recorded over a period up to 4.5 years . RESULTS In both the treatment groups , the size of the periapical lesions reduced significantly during the follow-up period . Complete radiographic healing was observed in 81 % of the cases in the one-visit group , and in 71 % of the cases in the two-visit group . The probability of success increased continuously over time for both treatment groups . Seven out of eight cases ( 87.5 % ) that showed a positive root-canal culture at the time of obturation healed . The number of colony forming units ( CFU ) in six out of eight positive canals was < 10(2 ) CFU mL(-1 ) . CONCLUSIONS Within the limitations of this study , no significant differences in healing of periapical radiolucency was observed between teeth that were treated in one visit ( without ) and two visits with inclusion of calcium hydroxide for 4 weeks . The presence of a positive bacterial culture ( CFU<10(2 ) ) at the time of filling did not influence the outcome of treatment OBJECTIVES This prospect i ve study was conducted to determine whether there is any significant difference in the incidence of postobturation pain after single- and multiple-visit root canal treatment ( RCT ) . METHODS The frequency of postobturation pain was recorded and evaluated over an observation period of 30 days in 291 of 300 consecutive patients receiving RCT . The patients were assigned r and omly and consecutively into either single- or multiple-visit groups . The canals of all teeth were prepared and filled by a single operator using the step-back and lateral condensation techniques . The data were analysed statistically to determine the relationship , if any , between the pain experienced and pulpal vitality , tooth type , pre-operative pain , and the sex and age of the patient . RESULTS Nine of the 300 patients were excluded from the analysis as they failed to attend for postoperative review s. A significantly higher incidence ( P < 0.01 ) of postobturation pain was found in the multiple-visit group ( 38 % ) than in the single-visit group ( 27 % ) within 24 h of obturation . The incidence of pain decreased thereafter , with all patients being sysmptom free at the end of the observation period . No significant correlation was found between postobturation pain and any other factor , with the exception that teeth which had nonvital pulp prior to treatment were associated with a significantly greater ( P < 0.005 ) incidence of postobutration pain . CONCLUSIONS Pain was significantly higher in the multiple-visit RCT group and significantly associated with the treatment of the nonvital pulp AIM This longitudinal , prospect i ve study ( 1 ) investigated the prevalence of post-obturation pain after root canal treatment and ( 2 ) evaluated the influence of factors affecting the pain experience . METHODOLOGY Twenty practitioners , comprising general dental practitioners , MSc graduates and Endodontists , participated in this study . The patient sample ( n = 415 ) was derived from consecutive patients attending the practitioners ' surgeries for root canal treatment on a single tooth . Demographic , medical history , preoperative and intra-operative data as well as pain experience on day 1 and day 2 after root canal obturation were recorded . Intensity of pain experienced was recorded on a visual analogue scale ( VAS ) of 0 - 5 . The data were analysed using logistic regression models . RESULTS The prevalence of post-obturation pain within 48 h after treatment was 40.2 % ( n = 167 ) but less than 12 % of patients experienced severe pain ( VAS 4 or 5 ) on either day 1 or day 2 . The factors that significantly influenced post-obturation pain experience were : gender ( OR = 0.434 , P < 0.001 ) , tooth type ( OR = 1.733 , P = 0.007 ) , size of periapical lesion ( OR = 0.493 , P = 0.004 ) , history of post-preparation pain ( OR = 4.110 , P = < 0.001 ) or generalized swelling ( OR = 3.435 , P = 0.005 ) and number of treatment visits ( OR = 2.604 , P < 0.001 ) . CONCLUSIONS The prevalence of post-obturation pain was high ( 40.2 % ) . The important prognostic determinants of post-obturation pain were female , molar tooth , size of periapical lesion smaller than 3 mm , history of post-preparation pain or generalized swelling and single-visit treatment Background Clincians have been providing single-visit and multiple-visit endodontic treatments for their patients . This study aims to compare the success rate , prevalence of postoperative pain and chairside time of single-visit and multiple-visit endodontic treatments . Method Patients who required primary endodontic treatment in a university dental clinic were r and omly allocated to two general dentists for single-visit or multiple-visit treatments using the same material s and procedures . Ni-Ti rotary files were used to prepare the root canals , which were subsequently obturated with a core-carrier technique . The chairside time was recorded . The treated teeth were followed up every 6 months on clinical ly signs and symptoms including pain , tenderness to percussion , sinus tract , mobility and abscess . Periapical radiographs were taken to assess periapical pathology . Successful treatments were neither clinical signs/symptoms noted nor radiographic periapical pathology found postoperatively . Results A total of 220 teeth from patients aged 46.4 ± 14.1 were followed up for at least 18 months . The mean ( ±SD ) follow-up period was 29.4 ± 9.3 months . The success rates of single-visit and multiple-visit treatments were 88.9 and 87.4 % , respectively ( p = 0.729 , effect size odds ratio = 1.156 ) . Maxillary teeth had odds ratios of 3.16 ( 95 % CI : 1.33 to 7.46 ; p = 0.009 ) and absence of preoperative apical periodontitis had odds ratios of 4.35 ( 95 % CI : 1.43 to 13.24 ; p = 0.010 ) were identified from logistic regression as having a higher success rate . The average chairside times of single-visit and multiple-visit treatments were 62.0 and 92.9 min , respectively ( mean difference = −30.9 , 95 % CI : −39.4 to −22.4 , p < 0.001 , effect size odds ratio = −0.996 ) . Single-visit and multiple-visit treatment had no significant difference in the prevalence of postoperative pain within 7 days ( 21 and 12 % , p = 0.055 , effect size odds ratio = 2.061 ) and after at least 18 months ( 0.9 and 1.0 % , p > 0.999 , effect size odds ratio = 0.879 ) . Conclusions The success rate and prevalence of postoperative pain of single-visit or multiple-visit treatment had no significant difference . The chairside time for single-visit treatment was shorter than multiple-visit treatment . Trial registration Clinical Trials ( WHO ) ChiCTR-IOR-15006117 registered on 20 March 2015 AIM This clinical study was undertaken to evaluate the postoperative sequelae following single-visit versus multiplevisit endodontic therapy at various interval of time in vital as well as nonvital teeth . MATERIAL S AND METHODS Thirty-two cases were r and omly assigned to the following four groups , group I , group II , group III and group IV . After gaining the access to the pulp chamber , establishing the working length , thorough cleaning and shaping was done for all the cases . Obturation was done by protaper ( variable taper ) gutta-percha and AH-PLUS sealer using lateral and vertical condensation technique . All the cases were recalled after 48 hours , 1 week , 4 weeks and 6 weeks following obturation and were evaluated for postoperative pain , tenderness and swelling . RESULTS There was no statistically significant difference amongst all the four groups in the incidence and severity of postoperative pain , tenderness and swelling at the end of one week . However , within 48 hours groups I , II and IV showed more pain when compared to group III . And groups I , II and III showed more tenderness compared with groups IV . Postoperative swelling was not reported . Radiographic investigation at the end of 6 weeks showed significant change in the appearance of the periapical region in group II and group IV cases . CONCLUSION On strict adherence to biological principles and proper case selection , no significant difference in the success , postoperative pain and tenderness exist when treated with either single-visit or multiple-visit therapy . CLINICAL SIGNIFICANCE No significant difference in the success rate or postoperative pain , tenderness , and swelling exists when treated with either single-visit or multiple-visit endodontic therapy . Hence , one can readily integrate one-visit endodontic therapy into the routine clinical practice of dentistry OBJECTIVES This prospect i ve study evaluated the frequency and intensity of postobturation pain and associated factors in adolescents undergoing one- and two-visit root canal treatment . METHODS 121 patients aged 11 - 18 years presenting with molars with pulp necrosis were assigned r and omly into two treatment groups : one- and two-visit ( including interappointment dressing with calcium hydroxide paste ) . The canals of all teeth were prepared using a preflaring ( 2/3 middle-cervical ) and step-back ( 1/3 apical ) preparation techniques and filled with laterally compacted gutta-percha and sealer . Postobturation pain was recorded on a visual analogue scale ( VAS ) of 0 - 5 . Data were statistically analyzed using multivariate logistic regression . RESULTS The frequencies of postobturation pain were 10.5 % ( 6/57 ) in the one-visit group and 23.0 % ( 14/61 ) in the two-visit group . There were no statistically significant differences between the groups ( p=0.07 ) . The intensity of the pain was similar in both groups , particularly flare-ups , with a prevalence of 1.75 % in the one-visit group and 1.65 % in the two-visit group . Postobturation pain was significantly associated with the presence of preoperative pain ( p=0.04 ; OR=3.54 ; CI 95%=1.02 - 12.30 ) and a positive culture at the time of obturation ( p=0.00 ; OR=9.43 ; CI 95%=2.93 - 30.35 ) . CONCLUSIONS Postobturation pain was more present in the two-visit group , but was not statistically significant . The intensity of postobturation pain was similar . Effective microbiological control and the presence of preoperative pain may influence the postobturation pain in adolescents Post obturation pain is the pain of any degree after endodontic treatment . There are different opinions regarding incidence of post obturation pain related to single and multi visit root canal treatment . This prospect i ve study was conducted to evaluate the incidence of post obturation pain in single visit and multi visit root canal treatment and to compare the incidence of pain between the two treatment groups . A total of 120 cases of endodontically involved asymptomatic non vital single rooted teeth were selected for this study . The patients were assigned and divided in to two treatment groups , sixty patients each . In single visit group , all teeth were prepared and filled using the st and ardized preparation and lateral condensation filling technique . In the multi visit treatment group , at the first appointment , the teeth were prepared , and dressed with calcium hydroxide paste for 7 days . At the second appointment , the teeth were prepared and obturated by using lateral condensation technique . The frequency of post obturation pain was recorded as no pain , slight , moderate and severe pain and evaluated at the day 1 and at the day 7 after obturation . The data were analyzed statistically by using SPSS version-12 . P value < 0.05 was taken as significant . The study showed that the post obturation pain in the single visit treatment group was more than multi visit treatment group , which is significant ( p value < 0.044 ) . Out of the 120 patients , 86(71.7 % ) patients had no pain , 19(15.8 % ) had slight pain and 15(12.5 % ) patients had moderate pain at the day 1 after obturation . At the day 7 after obturation , 108(90 % ) patients had no pain , 9(7.5 % ) had slight pain and 3(2.5 % ) patients had moderate pain . No patient noticed severe pain during the follow up period . Older patient had significantly more post obturation pain than the younger patient . There was higher incidence of post obturation pain following the single visit root canal treatment . In multi visit root canal treatment with intra- \n Output:\n " }, { "from": "agent", "value": "There is no evidence to suggest that one treatment regimen ( single-visit or multiple-visit root canal treatment ) is better than the other .\nNeither can prevent all short- and long-term complications .\nOn the basis of the available evidence , it seems likely that the benefit of a single-visit treatment , in terms of time and convenience , for both patient and dentist , has the cost of a higher frequency of late postoperative pain ( and as a consequence , painkiller 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: Abstract Background Diabetes prevalence is increasing . The Finnish Diabetes Prevention Study ( DPS ) showed a 58 % reduction in Type 2 Diabetes ( T2D ) incidence in adults with impaired glucose tolerance ( IGT ) . The European Diabetes Prevention Study ( EDIPS ) extends the DPS to different European population s , using the same study design . In the Newcastle arm of this study ( EDIPS-Newcastle ) , we tested the hypothesis that T2D can be prevented by lifestyle intervention and explored secondary outcomes in relation to diabetes incidence . Methods We recruited 102 participants ( 42 men and 60 women , mean age 57 years , mean BMI 34 kgm-2 ) with IGT to EDIPS-Newcastle and r and omised to Intervention and usual care Control groups . The intervention included individual motivational interviewing aim ed at : weight reduction , increase in physical activity , fibre and carbohydrate intake and reduction of fat intake ( secondary outcomes ) . The primary outcome was diagnosis of T2D . Results Mean duration of follow-up was 3.1 years . T2D was diagnosed in 16 participants ( I = 5 , C = 11 ) . Absolute incidence of T2D was 32.7 per 1000 person-years in the Intervention-group and 67.1 per 1000 person-years in the Control-group . The overall incidence of diabetes was reduced by 55 % in the Intervention-group , compared with the Control-group : RR 0.45 ( 95%CI 0.2 to 1.2).Explanatory survival analysis of secondary outcomes showed that those who sustained beneficial changes for two or more years reduced their risk of developing T2D . Conclusion Our results are consistent with other diabetes prevention trials . This study was design ed as part of a larger study and although the sample size limits statistical significance , the results contribute to the evidence that T2D can be prevented by lifestyle changes in adults with IGT . In explanatory analysis small sustained beneficial changes in weight , physical activity or dietary factors were associated with reduction in T2D incidence . Trial Registration International St and ard R and omised Controlled Trial Number registry ( IS RCT N)Registry number : IS RCT N 15670600 http://www.controlled-trials.com/is rct n/ search .html?srch=15670600%26sort=3%26dir = BACKGROUND Obesity exacerbates the age-related decline in physical function and causes frailty in older adults ; however , the appropriate treatment for obese older adults is controversial . METHODS In this 1-year , r and omized , controlled trial , we evaluated the independent and combined effects of weight loss and exercise in 107 adults who were 65 years of age or older and obese . Participants were r and omly assigned to a control group , a weight-management ( diet ) group , an exercise group , or a weight-management-plus-exercise ( diet-exercise ) group . The primary outcome was the change in score on the modified Physical Performance Test . Secondary outcomes included other measures of frailty , body composition , bone mineral density , specific physical functions , and quality of life . RESULTS A total of 93 participants ( 87 % ) completed the study . In the intention-to-treat analysis , the score on the Physical Performance Test , in which higher scores indicate better physical status , increased more in the diet-exercise group than in the diet group or the exercise group ( increases from baseline of 21 % vs. 12 % and 15 % , respectively ) ; the scores in all three of those groups increased more than the scores in the control group ( in which the score increased by 1 % ) ( P<0.001 for the between-group differences ) . Moreover , the peak oxygen consumption improved more in the diet-exercise group than in the diet group or the exercise group ( increases of 17 % vs. 10 % and 8 % , respectively ; P<0.001 ) ; the score on the Functional Status Question naire , in which higher scores indicate better physical function , increased more in the diet-exercise group than in the diet group ( increase of 10 % vs. 4 % , P<0.001 ) . Body weight decreased by 10 % in the diet group and by 9 % in the diet-exercise group , but did not decrease in the exercise group or the control group ( P<0.001 ) . Lean body mass and bone mineral density at the hip decreased less in the diet-exercise group than in the diet group ( reductions of 3 % and 1 % , respectively , in the diet-exercise group vs. reductions of 5 % and 3 % , respectively , in the diet group ; P<0.05 for both comparisons ) . Strength , balance , and gait improved consistently in the diet-exercise group ( P<0.05 for all comparisons ) . Adverse events included a small number of exercise-associated musculoskeletal injuries . CONCLUSIONS These findings suggest that a combination of weight loss and exercise provides greater improvement in physical function than either intervention alone . ( Funded by the National Institutes of Health ; Clinical Trials.gov number , NCT00146107 . ) OBJECTIVE To study the overall effect of the Active Prevention in High-Risk Individuals of Diabetes Type 2 in and Around Eindhoven ( APHRODITE ) lifestyle intervention on type 2 diabetes risk reduction in Dutch primary care after 0.5 and 1.5 years and to evaluate the variability between general practice s. RESEARCH DESIGN AND METHODS Individuals at high risk for type 2 diabetes ( Finnish Diabetes Risk Score ≥13 ) were r and omly assigned into an intervention group ( n = 479 ) or a usual-care group ( n = 446 ) . Comparisons were made between study groups and between general practice s regarding changes in clinical and lifestyle measures over 1.5 years . Participant , general practitioner , and nurse practitioner characteristics were compared between individuals who lost weight or maintained a stable weight and individuals who gained weight . RESULTS Both groups showed modest changes in glucose values , weight measures , physical activity , energy intake , and fiber intake . Differences between groups were significant only for total physical activity , saturated fat intake , and fiber intake . Differences between general practice s were significant for BMI and 2-h glucose but not for energy intake and physical activity . In the intervention group , the nurse practitioners ’ mean years of work experience was significantly longer in individuals who were successful at losing weight or maintaining a stable weight compared with unsuccessful individuals . Furthermore , successful individuals more often had a partner . CONCLUSIONS Risk factors for type 2 diabetes could be significantly reduced by lifestyle counseling in Dutch primary care . The small differences in changes over time between the two study groups suggest that additional intervention effects are modest . In particular , the level of experience of the nurse practitioner and the availability of partner support seem to facilitate intervention success OBJECTIVE Changing dietary and physical activity habits has the potential to postpone or prevent the development of type 2 diabetes . However , it needs to be assessed whether moderate interventions , in agreement with current guidelines for the general population , are effective . We evaluated the impact of a 2-year combined diet and physical activity intervention program on glucose tolerance in Dutch subjects at increased risk for developing diabetes . RESEARCH METHODS AND PROCEDURES Subjects with glucose intolerance were r and omly assigned to either the lifestyle intervention group ( INT ) or control group ( CON ) . The INT received regular dietary advice and was stimulated to increase their physical activity . The CON received a brief leaflet about healthy diet and increased physical activity . Primary outcome measure was the change in glucose tolerance . RESULTS In total , 88 subjects completed 2 years of intervention ( 40 subjects in the INT , 48 subjects in the CON , mean BMI 29.4 kg/m2 ) . Subjects in the INT reduced their body weight , waist circumference , and ( saturated ) fat intake and improved their aerobic capacity . Two-hour plasma glucose concentration declined from 8.7 to 8.0 mM in the INT and rose from 8.6 to 9.4 mM in the CON ( p < 0.01 ) . Subjects adherent to both the diet and exercise intervention showed the largest reduction in 2-hour glucose levels . DISCUSSION Our results showed that a lifestyle intervention program according to general recommendations improves glucose tolerance , even in a less obese and more physical active population . Furthermore , our results underscore the importance of combining diet and physical activity to improve glucose tolerance and insulin resistance Exercise is the best predictor of long-term weight loss . This study evaluated two strategies for improving exercise adherence and long-term weight loss in obese out patients . Obese men and women ( N = 193 ) were r and omized to 1 of 5 treatment groups for 18 months : st and ard behavior therapy ( SBT ) ; SBT with supervised walks ( SW ) 3 times per week ; SBT + SW with personal trainers ( PT ) , who walked with participants , made phone reminders , and did make-up SW ; SBT + SW with monetary incentives ( I ) for completing SW ; and SBT + SW + PT + I. Both PT and I enhanced attendance at SWs , the combination producing the best adherence . Increased walk attendance did not result in higher overall energy expenditure , however , and long-term weight loss was also not improved . Post hoc analyses suggest that the level of exercise needed for successful long-term weight loss is much higher than that usually recommended in behavioral treatment programs Summary Background The increasing prevalence of overweight and obesity needs effective approaches for weight loss in primary care and community setting s. We compared weight loss with st and ard treatment in primary care with that achieved after referral by the primary care team to a commercial provider in the community . Methods In this parallel group , non-blinded , r and omised controlled trial , 772 overweight and obese adults were recruited by primary care practice s in Australia , Germany , and the UK . Participants were r and omly assigned with a computer-generated simple r and omisation sequence to receive either 12 months of st and ard care as defined by national treatment guidelines , or 12 months of free membership to a commercial programme ( Weight Watchers ) , and followed up for 12 months . The primary outcome was weight change over 12 months . Analysis was by intention to treat ( last observation carried forward [ LOCF ] and baseline observation carried forward [ BOCF ] ) and in the population who completed the 12-month assessment . This trial is registered , number IS RCT N85485463 . Findings 377 participants were assigned to the commercial programme , of whom 230 ( 61 % ) completed the 12-month assessment ; and 395 were assigned to st and ard care , of whom 214 ( 54 % ) completed the 12-month assessment . In all analyses , participants in the commercial programme group lost twice as much weight as did those in the st and ard care group . Mean weight change at 12 months was −5·06 kg ( SE 0·31 ) for those in the commercial programme versus −2·25 kg ( 0·21 ) for those receiving st and ard care ( adjusted difference −2·77 kg , 95 % CI −3·50 to −2·03 ) with LOCF ; −4·06 kg ( 0·31 ) versus −1·77 kg ( 0·19 ; adjusted difference −2·29 kg , −2·99 to −1·58 ) with BOCF ; and −6·65 kg ( 0·43 ) versus −3·26 kg ( 0·33 ; adjusted difference −3·16 kg , −4·23 to −2·11 ) for those who completed the 12-month assessment . Participants reported no adverse events related to trial participation . Interpretation Referral by a primary health-care professional to a commercial weight loss programme that provides regular weighing , advice about diet and physical activity , motivation , and group support can offer a clinical ly useful early intervention for weight management in overweight and obese people that can be delivered at large scale . Funding Weight Watchers International , through a grant to the UK Medical Research Council Developing more effective behavioural interventions requires an underst and ing of the mechanisms of behaviour change , and methods to rigorously test their theoretical basis . The delivery and theoretical basis of an intervention protocol were assessed in ProActive , a UK trial of an intervention to increase the physical activity of those at risk of Type 2 diabetes ( N = 365 ) . In 108 intervention sessions , behaviours of facilitators were mapped to four theories that informed intervention development and behaviours of participants were mapped to 17 theoretical components of these four theories . The theory base of the intervention specified by the protocol was different than that delivered by facilitators , and that received by participants . Of the intervention techniques delivered , 25 % were associated with theory of planned behaviour ( TPB ) , 42 % with self-regulation theory ( SRT ) , 24 % with operant learning theory ( OLT ) and 9 % with relapse prevention theory ( RPT ) . The theoretical classification of participant talk showed a different pattern , with twice the proportion associated with OLT ( 48 % ) , 21 % associated with TPB , 31 % with SRT and no talk associated with RPT . This study demonstrates one approach to assessing the extent to which the theories used to guide intervention development account for any changes observed Background This study assessed the effect of a 1-year internet-based weight loss intervention for men . Methods Four hundred forty-one overweight and obese men were r and omized to intervention or delayed treatment . Participants completed a Web-based assessment of diet and physical activity behaviors and weekly tailored Web modules addressing weight-related behaviors . Results At 12 months compared to controls , intervention men decreased percent of energy from saturated fat and increased grams of fiber \n Output:\n " }, { "from": "agent", "value": "There was no evidence that other programme characteristics were associated with programme effectiveness .\nMost but not all behavioural weight management programmes are 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: BACKGROUND The antimigraine drugs ergotamine and sumatriptan may cause angina-like symptoms , possibly result ing from coronary artery constriction . We compared the coronary vasoconstrictor potential of a number of current and prospect i ve antimigraine drugs ( ergotamine , dihydroergotamine , methysergide and its metabolite methylergometrine , sumatriptan , naratriptan , zolmitriptan , rizatriptan , avitriptan ) . METHODS AND RESULTS Concentration-response curves to the antimigraine drugs were constructed in human isolated coronary artery segments to obtain the maximum contractile response ( Emax ) and the concentration eliciting 50 % of Emax ( EC50 ) . The EC50 values were related to maximum plasma concentrations ( Cmax ) reported in patients , obtaining Cmax/EC50 ratios as an index of coronary vasoconstriction occurring in the clinical setting . Furthermore , we studied the duration of contractile responses after washout of the acutely acting antimigraine drugs to assess their disappearance from the receptor biophase . Compared with sumatriptan , all drugs were more potent ( lower EC50 values ) in contracting the coronary artery but had similar efficacies ( Emax < 25 % of K+-induced contraction ) . The Cmax of avitriptan was 7- to 11-fold higher than its EC50 value , whereas those of the other drugs were < 40 % of their respective EC50 values . The contractile responses to ergotamine and dihydroergotamine persisted even after repeated washings , but those to the other drugs declined rapidly after washing . CONCLUSIONS All current and prospect i ve antimigraine drugs contract the human coronary artery in vitro , but in view of low efficacy , these drugs are unlikely to cause myocardial ischemia at therapeutic plasma concentrations in healthy subjects . In patients with coronary artery disease , however , these drugs must remain contraindicated . The sustained contraction by ergotamine and dihydroergotamine seems to be an important disadvantage compared with sumatriptan-like drugs OBJECTIVE To investigate the cost-effectiveness and cost-benefit of initiating sumatriptan therapy in patients with acute migraine who were previously taking nontriptan drugs . PATIENTS AND METHODS This is an economic analysis of a prospect i ve , pretest-posttest , observational 6-month outcomes study of 178 patients with a physician diagnosis of migraine who received their first prescription for sumatriptan between October 1994 and August 1996 and were members of a mixed-model managed care organization in western Pennsylvania . Migraine-related re source use data were obtained from the managed care organization 's medical and pharmacy cl aims data bases . The primary outcome measure for this economic analysis was the total disability time that patients experienced because of migraine . Patients reported time missed from work and usual nonwork activities because of migraine on self-administered question naires at baseline and at 3 and 6 months after initiation of sumatriptan . RESULTS Initiation of sumatriptan result ed in a decrease of 662 migraine-disability-days for work and 1236 migraine-disability-days for nonwork activities during the 6 months of the study ( decrease from 27.8 to 17.2 days per person ) , totaling 1898 migraine-disability-days averted with sumatriptan therapy . Migraine-related medical costs were lower after sumatriptan was initiated ( $ 18,351 vs $ 26,192 ) , whereas migraine-related pharmacy costs were lower with prior nontriptan drug therapy ( $ 22,209 vs $ 74,861 ) . The overall net cost savings after sumatriptan was initiated in these patients was $ 222,332 ( $ 1249 per patient ) with a benefit-to-cost ratio of $ 5.67 gained for each health care dollar spent from a societal perspective . The incremental cost-effectiveness ratio was $ 25 for each additional migraine-disability-day averted by using sumatriptan vs nontriptan drug therapy . Sensitivity analysis showed that changes in medical costs had little effect on the ratios and that sumatriptan remained cost-beneficial across a wide range of patient wages . CONCLUSION This study showed that initiation of sumatriptan in patients previously receiving nontriptan therapy was cost-effective and had an economic benefit for patients , employers , and society . Sumatriptan also helped patients and physicians achieve goals recommended by the US Headache Consortium by reducing patients ' disability and thus improving their ability to function at work and nonwork activities STUDY OBJECTIVE We compare prochlorperazine 10 mg intravenously versus metoclopramide 20 mg intravenously for the emergency department ( ED ) treatment of acute migraine . METHODS This was a r and omized , double-blind , clinical trial comparing 2 parenteral dopamine antagonists . Both drugs were administered during 15 minutes with 25 mg intravenous diphenhydramine . Pain scores on a numeric rating scale were assessed at baseline , every 30 minutes for 2 hours , and by telephone 24 hours after discharge . The primary endpoint was the between-group difference in change in numeric rating scale from baseline to 1 hour postbaseline . Secondary endpoints included mean differences in change in numeric rating scale at 2 and 24 hours , headache relief , adverse effects , and desire to receive the same treatment for future migraines . RESULTS Of 152 patients screened , 97 were eligible and 77 were r and omized . The mean change in numeric rating scale scores at 1 hour was 5.5 and 5.2 in subjects receiving prochlorperazine and metoclopramide , respectively ( difference=0.3 ; 95 % confidence interval [ CI ] -1.0 to 1.6 ) . Findings were similar at 2 hours and 24 hours . Forty-six percent ( 18/39 ) of prochlorperazine and 32 % ( 12/38 ) of metoclopramide subjects reported adverse events ( difference=15 % ; 95 % CI -6 % to 36 % ) . Seventy-seven percent ( 26/34 ) of prochlorperazine and 73 % ( 27/37 ) of metoclopramide subjects wanted to receive the same medication in future ED visits ( difference=4 % ; 95 % CI -16 % to 24 % ) . CONCLUSION Either prochlorperazine 10 mg intravenously or metoclopramide 20 mg intravenously , combined with diphenhydramine 25 mg intravenously , is an efficacious treatment for ED patients with acute migraine . Three quarters of subjects in both arms would want the same medication for their next migraine The aim of this prospect i ve , r and omised , double – blind study was to evaluate the efficacy of intramuscular ( IM ) tramadol 100 mg in emergency department treatment of acute migraine attack and to compare it with that of IM diclofenac sodium 75 mg . Forty patients who were admitted to our emergency department with acute migraine attack according to the International Headache Society criteria were included in the study . Patients were r and omised to receive either tramadol 100 mg ( n=20 ) or diclofenac sodium 75 mg ( n=20 ) intramuscularly . Patients rated their pain on a four – point verbal scale ( 0=none , 1=mild , 2=moderate , 3=severe ) at the beginning of the trial and at 30 , 60 , 90 and 120 min . At each time interval , severity of associated symptoms were also question ed and recorded . Global evaluation of the drugs by patients and doctors were also recorded . Patients were also asked if they would prefer the same injection in future visits . Any adverse events , whether related to the drug or not , were also recorded . Patients were followed up by telephone 48 h later to check for any headache recurrence . Two – hour pain response rate , which was the primary endpoint , was 80 % for both tramadol and diclofenac groups . There were no statistically significant differences among groups in terms of 48–h pain response , rescue treatment , associated symptoms ’ response , headache recurrence and adverse event rates . Fifteen ( 75 % ) patients in the tramadol group and 16 ( 80 % ) patients in the diclofenac group stated that they may prefer the same agent for future admissions . In selected patients , tramadol 100 mg IM may be an effective and reliable alternative treatment choice in acute migraine attacks OBJECTIVE To assess the efficacy and tolerability of subcutaneous dihydroergotamine mesylate ( DHE-45 ) vs subcutaneous sumatriptan succinate ( Imitrex ) for the treatment of acute migraine with or without aura . DESIGN Double-blind , r and omized trial with parallel treatment arms . SETTING Clinics and private neurology practice s. SUBJECTS Patients of either sex , with migraine with or without aura , between the ages of 18 and 65 years . INTERVENTIONS Patients with moderate or severe head pain were r and omized to receive either 1 mg of subcutaneous dihydroergotamine mesylate or 6 mg of subcutaneous sumatriptan succinate . Patients rated head pain , functional ability , nausea , and vomiting at baseline and at 0.5 , 1 , 2 , 4 , and 24 hours after the injection . Presence or absence of headache at 3 hours was calculated from collected data . If pain persisted after 2 hours , a second injection of the same study medication was allowed , and self-ratings were repeated 30 and 60 minutes later . Follow-up data were collected at 24 hours . MAIN OUTCOME MEASURES Relief of head pain and recurrence of successfully treated headache . RESULTS There were 295 evaluable patients . At 2 hours , 73.1 % of the patients treated with dihydroergotamine and 85.3 % of those treated with sumatriptan had relief ( P = .002 ) . There was no statistical difference in headache relief between the groups at 3 or 4 hours . Headache relief was achieved by 85.5 % of those treated with dihydroergotamine and by 83.3 % of those treated with sumatriptan by 4 hours . By 24 hours 89.7 % of dihydroergotamine-treated patients and 76.7 % of sumatriptan-treated patients had relief ( P = .004 ) . Headache recurred within 24 hours after treatment in 45 % of the sumatriptan-treated patients and in 17.7 % of the dihydroergotamine-treated patients ( P < or = .001 ) . CONCLUSIONS Both sumatriptan and dihydroergotamine were effective in aborting migraine headaches . Headache recurrence was two and a half time as likely with sumatriptan as with dihydroergotamine STUDY OBJECTIVE We test the hypothesis that intravenous magnesium sulfate is an effective adjunctive medication for treatment of acute migraine . METHODS In this r and omized , double-blind , placebo-controlled trial , adults presenting to 2 urban emergency departments with headache meeting International Headache Society criteria for acute migraine received either 20 mg of intravenous metoclopramide plus 2 g of intravenous magnesium sulfate or 20 mg of intravenous metoclopramide plus a placebo of intravenous saline solution at 15-minute intervals for a maximum of 3 doses or until pain relief occurred . At 0 , 15 , 30 , and 45 minutes , patients recorded pain intensity using a st and ard visual analog scale ( VAS ) . The primary study end point was the between-group difference in pain improvement when initial and final VAS scores were compared . RESULTS Of 44 patients enrolled ( 21 r and omized to metoclopramide plus magnesium and 23 to metoclopramide plus placebo ) , 42 ( 95 % ) were women . Baseline features were comparable in both groups . Each group experienced a more than 50-mm improvement in VAS score during the study . However , this improvement was smaller in the magnesium group for the primary end point ( 16-mm difference favoring placebo [ 95 % confidence interval ( CI ) -2 to 34 mm ] ) , as was the proportion with normal functional status at their final rating ( 36 % absolute difference also favoring placebo [ 95 % CI 7 % to 65 % ] ) . Using a 50 % reduction in pain to dichotomize VAS scores , the number needed to harm with magnesium plus metoclopramide versus metoclopramide alone is 4 patients ( 95 % CI 2 to 36 ) . CONCLUSION Although this result was unexpected , our data suggest that the addition of magnesium to metoclopramide may attenuate the effectiveness of metoclopramide in relieving migraine . Countertherapeutic cerebral vasodilatation caused by magnesium is a plausible , although unproven , explanation for this finding . Because of the preponderance of women in our trial , these data may not be generalizable to men Background There are many drugs recommended for pain relief in patients with migraine headache . Methods In a prospect i ve double blind r and omized clinical trial , 90 patients ( age ≥ 18 ) presenting to Emergency medicine Department with Migraine headache were enrolled in two equal groups . We used intravenous propofol ( 10 mg every 5–10 minutes to a maximum of 80 mg , slowly ) and intravenous dexamethasone ( 0. \n Output:\n " }, { "from": "agent", "value": "Interpretation We strongly recommend the use of prochlorperazine based on a high level of evidence , lysine acetylsalicylic acid , metoclopramide and sumatriptan , based on a moderate level of evidence , and ketorolac , based on a low level of evidence .\nWe weakly recommend the use of chlorpromazine based on a moderate level of evidence , and ergotamine , dihydroergotamine , lidocaine intranasal and meperidine , based on a low level of evidence .\nWe found evidence to recommend strongly against the use of dexamethasone , based on a moderate level of evidence , and granisetron , haloperidol and trimethobenzamide based on a low level of evidence .\nBased on moderate- quality evidence , we recommend weakly against the use of acetaminophen and magnesium sulfate .\nBased on low- quality evidence , we recommend weakly against the use of diclofenac , droperidol , lidocaine intravenous , lysine clonixinate , morphine , propofol , sodium valproate and tramadol" } ]

[ { "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: Guided bone regeneration ( GBR ) is frequently used in oral implantology . It is unclear to what extent GBR affects the periodontium of adjacent teeth . Therefore , the present study quantifies changes in the proximal gingiva and bone levels at these teeth in 30 patients . Staged surgery involved a st and ard GBR treatment , r and omly using resorbable membranes with a bone substitute or non-resorbable membranes with or without a bone substitute , followed by fixture installation at 6 months and abutment connection a further 6 months later . The data were sample d at each surgery and analysed using MANOVA . Twelve months after GBR , there was on average a small but statistically significant amount of proximal gingival recession ( 0.75 mm ) and bone resorption ( 0.34 mm ) observed , of which 50 % was the result of GBR surgery . No significant differences were found between the different GBR treatment modalities . It is concluded that GBR treatment may have a small negative effect on the levels of the free gingival margin and alveolar bone at adjacent teeth , which is in most patients not clinical ly relevant PURPOSE The aim of this study was to report on the rehabilitation of partial edentulism with immediate function implants placed in predominantly soft bone with flap and flapless surgical techniques . MATERIAL S AND METHODS The prospect i ve clinical study comprises 72 implants ( 50 in the maxilla and 22 in the m and ible ) placed in 41 consecutively included patients rehabilitated from partial edentulism , followed for 1 year . An implant specially design ed for immediate function was used . The evaluation included clinical examinations and radiographic assessment of the marginal bone level at 6 months and 1 year . The outcome measure was the implant success , evaluated using the following implant success criteria : clinical stability ( fixed dental prostheses removed and implants individually checked ) ; fulfilled purported function without any discomfort to the patient ; no suppuration or infection present ; no radiolucent areas around the implants at time of evaluation ; and no aesthetic complaints from the patient . RESULTS No dropouts were registered during the follow-up of the study . The overall cumulative survival rate at 1 year was 98.6 % ( 1 implant lost ) , with 100 % for the implants placed with the flap surgical technique , and 96.9 % for the implants placed with the flapless surgical technique . The overall average marginal bone resorption was 1.6 mm ( SD=1.1 mm ) at 1-year follow-up , with 1.4 mm ( SD=0.8 mm ) and 2.0 mm ( SD = 1.4 mm ) for the flap and flapless surgical technique study groups , respectively . The complications registered were : peri-implant pathology ( 3 implants in 3 patients ) ; fracture of the provisional crown/prosthesis ( 2 patients ) ; crown loosening ( 1 patient ) and prosthetic screw loosening ( 1 patient ) . CONCLUSIONS The placement of the specially design ed implant for immediate function in predominantly soft bone is viable , as given by the overall 98.6 % cumulative survival rate , and the rehabilitation using flapless surgery is safe and predictable . However , the flapless technique revealed more marginal bone resorption compared with the flap technique . Extra care should be taken in the flapless approach with respect to the inclusion criteria and difficulty of the surgery Background The association between periodontal conditions , oral yeast colonisation and salivary proteins in subjects with type 2 diabetes ( T2D ) is not yet documented . The present study aim ed to assess the relationship between these variables in type 2 diabetic subjects with reference to gender . Methods Fifty-eight type 2 diabetic subjects ( 23 males and 35 females ) with r and om blood glucose level ≥ 11.1 mmol/L were investigated . Periodontal conditions ( plaque index [ PI ] , bleeding on probing [ BOP ] , probing pocket depth [ PD ] ( 4 to 6 mm and ≥ 6 mm ) , oral yeasts , salivary immunoglobulin ( Ig ) A , IgG and total protein concentrations , and number of present teeth were determined . Results Periodontal conditions ( PI [ p < 0.00001 ] , BOP [ p < 0.01 ] and PD of 4 to 6 mm [ p < 0.001 ] , salivary IgG (μg)/mg protein ( p < 0.001 ) and salivary total protein concentrations ( p < 0.05 ) were higher in type 2 diabetic females with C and ida albicans ( C. albicans ) colonisation compared to males in the same group . Type 2 diabetic females with C. albicans colonisation had more teeth compared to males in the same group ( p < 0.0001 ) . Conclusion Clinical and salivary parameters of periodontal inflammation ( BOP and IgG (μg)/mg protein ) were higher in type 2 diabetic females with oral C. albicans colonisation compared to males in the same group . Further studies are warranted to evaluate the association of gender with these variables in subjects with T2D BACKGROUND The association among periodontal conditions , socioeconomic status ( SES ) , and diabetes has been reported . However , there is a lack of published data comparing periodontal conditions among individuals with poorly controlled type 2 diabetes mellitus ( T2D ) . The aim of the present study was to compare the periodontal conditions and SES between subjects with T2D and non-diabetic controls . METHODS A total of 75 ( 31 males and 44 females ) individuals with T2D ( 62 poorly controlled and 13 well-controlled ) and 99 non-diabetic patients ( healthy controls ; 51 males and 48 females ) participated in the study . Plaque index ( PI ) , bleeding on probing ( BOP ) , and probing depth ( PD ) were investigated . R and om blood glucose level was recorded . Premolar and molar marginal bone loss ( MBL ) was measured digitally on scanned orthopantomograms . RESULTS Individuals with poorly controlled T2D had increased MBL in molars and maxillary premolars ( P<0.05 ) compared to individuals with well-controlled T2D . PI , BOP , and PD of 4 to < 6 mm were increased in individuals with poorly controlled T2D compared to those with well-controlled T2D ( P<0.001 ) . There was no difference between the diabetic groups when PD was > or=6 mm . Individuals with poorly controlled T2D had a lower SES compared to patients with well-controlled T2D ( P<0.05 ) . Illiteracy and the number of missing teeth were not different between the groups . CONCLUSIONS Radiologic and clinical indicators of periodontal destruction were increased in individuals with poorly controlled T2D . Low SES aggravated the periodontal condition in individuals with T2D The purpose of this r and omized controlled clinical study was to compare the survival of a one-piece anodically oxidized surface implant when placed with a flapless or flap protocol . Bone loss measurements on radiographs and changes in clinical probing depths 1 year post-definitive restoration placement were recorded and compared . Fifty-two of 60 patients ( implants ) remained in the study at the 1-year follow-up . At the time of final evaluation , no implant was lost in either group . At the time of placement of the definitive restoration , there was a mean mesial and distal bone gain in both groups compared to bone levels present at the time of implant insertion . There were no significant changes in bone levels between placement of the definitive restoration and those recorded 12 months later , and no significant differences in bone levels between the flap or flapless group at 6 or 12 months were noted . No significant differences were seen either in pocket depth or change in pocket depth at 6 and 12 months in the flapless and flap groups . It was therefore concluded that one-piece anodically oxidized surface implants , 1 year post-definitive restoration insertion , had high survival rates ( 100 % ) and stable marginal bone and probing depth levels whether a flapless or flap protocol was used for implant insertion OBJECTIVES To evaluate and compare the outcome of dental implants placed using a flapless protocol and immediate loading with a conventional protocol and loading after 6 weeks . MATERIAL S AND METHODS Fourteen patients with bilateral maxillary edentulous areas were treated using Straumann SLA-implants . Using a r and omized split-mouth design , implants were placed in one side of the maxilla using a stereolithographic surgical guide for flapless surgery and immediately loaded on temporary abutments with a bridge ( test ) . Implants in the other side were placed using the conventional protocol and loaded after 6 weeks of healing ( control ) . Clinical and radiographic evaluation of peri-implant tissues was performed at time of implant surgery , and after 1 week , 6 weeks , 3 , 6 , 12 and 18 months . RESULTS A total of 70 implants were placed ( 36 test and 34 control ) . One implant ( test ) was lost after 3 months , result ing in a survival rate of 97.3 % for the test implants and 100 % for the control implants . Marginal bone levels were not statistically significantly different between the test and control implants but at baseline the marginal bone level was significantly lower compared to the other evaluation periods ( P < 0.05 ) . The mean bone level for test and control implants was 1.95 mm ± 0.70 and 1.93 mm ± 0.42 after 18 months , respectively . There was a significant change in height of the attached mucosa at implants placed with a conventional flap between post-operative and 1 week and between 1 week and 6 weeks . Statistically significant differences were found between the test side and the control side for opinion about speech , function , aesthetics , self-confidence and overall appreciation the first 6 weeks . CONCLUSION Implants can successfully integrate in the posterior maxilla using a flapless approach with immediate loading similar to a conventional protocol . The mucosal tissues around implants placed with a conventional flap changed significantly compared with flapless placed implants PURPOSE To evaluate and compare the changes in crestal bone height around implants placed with flapless surgery and with-flap surgery . MATERIAL S AND METHODS Ten implants were placed in six patients --five using flapless and five using with-flap techniques . Single-piece root-form implants and a one-stage approach with immediate nonfunctional loading protocol were used . The change in heights of crestal bone was measured on st and ardized digital periapical radiographs taken at 0 , 1 , and 3 months . RESULTS On mesial side , the mean change from months 0 - 1 , months 1 - 3 , and months 0 - 3 for flapless method was significantly lower than with-flap method [ 0.01 - 0.06 mm for flapless and 0.13 - 0.40 mm for with-flap ( P = 0.01 ) ] . On the distal side , the mean change from months 0 - 1 , months 1 - 3 , and months 0 - 3 for flapless method was significantly lower than with-flap method [ 0.02 - 0.05 mm for flapless and 0.09 - 0.30 mm for with-flap ( P = 0.01 ) ] . CONCLUSIONS During the three-month period , reduction of crestal bone height around the implants placed with flapless surgery ( 0.06 mm ) was not statistically significant , while the reduction of crestal bone height around the implants placed using with-flap surgery ( 0.4 mm ) was statistically significant . Comparitively , flapless approach showed lesser crestal bone height reduction , which was statistically significant OBJECTIVE To evaluate how bone-level implants maintain crestal bone stability after thickening of thin mucosal tissues with allogenic membrane . MATERIAL S AND METHODS Ninety-seven bone-level implants of 4.1 mm diameter ( Institute Straumann AG , Switzerl and ) were evaluated in 97 patients ( 28 men and 69 women , mean age 47.3 ± 1.2 years ) . According to vertical gingival thickness , patients were assigned into test T1 ( thin , 2 mm or less , n = 33 ) , test T2 ( thin thickened with allogenic membrane , n = 32 ) and control C groups ( thick , more than 2 mm , n = 32 ) . Implants were placed in posterior m and ible in one-stage approach and after integration were restored with single screw-retained metal-ceramic restorations . Radiographic examination was performed after implant placement , 2 months after healing , after prosthetic restoration and after 1-year follow-up . Crestal bone loss was calculated mesially and distally . Mann-Whitney U-test was applied and significance was set to 0.05 . RESULTS After 2 months , implants in group T1 had 0.75 ± 0.11 mm bone loss mesially and 0.73 ± 0.10 mm distally . Implants in group T2 had 0.16 ± 0.06 mm mesially and 0.20 ± 0.06 mm distally . C group implants lost 0.17 ± 0.05 mm mesially and 0.18 ± 0.03 mm distally . Differences between T1/T2 , and T1/C were statistically significant ( P = 0.000 ) both mesially and distally , while between T2 and C was not significant mesially ( P = 0.861 ) and distally ( P = 0.827 ) . \n Output:\n " }, { "from": "agent", "value": "CBL around dental implants placed in healed sites using flapped and flapless techniques is comparable" } ]

[ { "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 previously reported on a 7-day course of dexamethasone starting at 0.5 mg/kg/day in intubated very low birth weight ( VLBW ) infants , 7 - 14 days of age , with increased dynamic pulmonary compliance and decreased bronchopulmonary dysplasia ( BPD ) . The effect of low-dose dexamethasone on functional residual capacity ( FRC ) in VLBW infants is unknown . The objective of this study was to compare the effect of two regimens of moderately early dexamethasone on FRC and passive respiratory compliance ( Crs ) in VLBW infants at risk for BPD . Sixty-two intubated VLBW infants were r and omized ( double-blinded ) at 7 - 21 days of age ; 29 patients ( mean birth weight , 839 g ) received \" high \" dose dexamethasone ( 0.5 mg/kg/day for 3 days , 0.25 mg/kg/day for 3 days , and 0.1 mg/kg/day on day 7 , total dose of 2.35 mg/kg ) , and 33 infants ( mean birth weight , 830 g ) received \" low-dose \" dexamethasone ( 0.2 mg/kg/day for 3 days and 0.1 mg/kg/day for 4 days , total dose of 1 mg/kg ) . FRC and Crs were measured with the nitrogen washout technique and single breath occlusion technique , before and on days 2 , 5 , and 7 of therapy . Clinical outcome and early neurodevelopmental follow-up were evaluated . FRC significantly increased in the high-dose ( 19.3 ml/kg at baseline to 34 ml/kg on day 7 ; P < 0.001 ) and low-dose ( 18.1 ml/kg at baseline to 30.3 ml/kg on day 7 ; P < 0.001 ) dexamethasone groups when compared to baseline . There was a significant increase in Crs and a decrease in FiO2 within each group . The improvements in FRC and Crs were comparable between groups , and specific compliances ( Crs/FRC ) were not different . There were no significant differences in other clinical outcome parameters , including BPD and neurodevelopmental outcome . In conclusion , there are significant increases in FRC during a 7-day course of moderately early dexamethasone in VLBW infants . The lower total dose ( 1 mg/kg ) appears as effective as the higher total dose of dexamethasone ( 2.35 mg/kg ) in increasing FRC . Comparable significant increases in Crs were observed in both groups of infants . Additional long-term follow-up is underway In a multicenter trial of steroid therapy for chronic neonatal oxygen dependence , 287 neonates were r and omly allocated from around 3 weeks of age , to dexamethasone or placebo . Active treatment significantly reduced the duration of further assisted ventilation among infants who were ventilator dependent at entry ( median days for survivors , 11 vs 17.5 ) . There were no statistically significant differences between the total groups of survivors in time receiving supplemental oxygen and length of stay in hospital , although the trend favored the dexamethasone group . Twenty-five infants in each group died prior to hospital discharge ; most were ventilator dependent at trial entry . Open treatment with steroids was later given to 18 % in the active group and to 43 % in the placebo group . There was no evidence of serious side effects ; in particular , infection rates were similar in the two groups OBJECTIVE To compare duration of ventilation to mortality and adverse neurodevelopmental outcomes among extremely low birth weight ( ELBW ; 501 - 1000 g ) infants . STUDY DESIGN Retrospective analysis of prospect ively collected data from 5364 infants with a birthweight of 501 to 1000 g born at National Institute of Child Health and Human Development ( NICHD ) Neonatal Research Network centers from 1995 to 1998 . The main outcome measures were : survival , duration of mechanical ventilation , and neurodevelopmental outcome . RESULTS Overall survival was 71 % . The median duration of ventilation for survivors was 23 days ; 75 % were free of mechanical ventilation by 39 days , and 7 % were ventilated for > or = 60 days . Of those ventilated for > or = 60 days , 24 % survived without impairment . Of those ventilated for > or = 90 days , only 7 % survived without impairment . Of those ventilated > or = 120 days , all survivors were impaired . CONCLUSIONS The prognosis for ELBW with protracted ventilation remains grim . The cohort who remain intubated have diminished survival and high rates of impairment . Parents of these infants should be informed of changes in prognosis as the time of ventilation increases Two historical cohorts ( 1993–1994 and 2001 ) of preterm infants ventilated for respiratory distress syndrome were compared . Dexamethasone administration fell from 22 % to 6 % . Chronic lung disease in survivors rose slightly from 13 % to 17 % , and mortality fell from 21 % to 15 % ( other causes ) . The effect of restriction of dexamethasone use on chronic lung disease and mortality remains to be seen A r and omized trial was conducted of dexamethasone therapy in infants with bronchopulmonary dysplasia who were dependent on respirators and were not progressing clinical ly despite conventional treatment . Babies were admitted to the study if they had a roentgenogram and clinical diagnosis of bronchopulmonary dysplasia , were 2 to 6 weeks in age , weighed less than 1,500 g , had made no progress in weaning for the preceding five days , and were free of sepsis , patent ductus arteriosus , and congenital heart disease , and had had no intravenous fat for at least 24 hours . After parental consent was obtained , infants were r and omly assigned to control or treatment groups . The study hypothesis was that with steroid treatment , babies could be weaned from the respirator within 72 hours and would show a significant improvement in lung compliance within that time . Sequential analysis exceeded criterion ( P less than .05 ) when seven consecutive untied pairs showed weaning with dexamethasone and failure to wean in control infants . Pulmonary compliance improved by 64 % in the treated group and 5 % in the control group ( P less than .01 ) . No significant intergroup differences were noted in mortality , length of hospital stay , sepsis , hypertension , hyperglycemia , or electrolyte abnormalities . Study design permits the conclusion that dexamethasone can produce substantial short-term improvement in lung function , often permitting rapid weaning from the respirator , but long-term efficacy and safety must be demonstrated by further investigations OBJECTIVE . Low-dose dexamethasone facilitates extubation in chronically ventilator-dependent infants with no obvious short-term complications . The objective of this study was to determine the long-term effects of low-dose dexamethasone . METHODS . Very preterm ( < 28 weeks ' gestation ) or extremely low birth weight ( birth weight < 1000 g ) infants who were ventilator dependent after the first week of life for whom clinicians considered corticosteroids were indicated were eligible . After informed consent , infants were r and omly assigned to masked dexamethasone ( 0.89 mg/kg over 10 days ) or saline placebo . Survivors were assessed at 2 years ' corrected age by staff blinded to treatment group allocation to determine neurosensory outcome , growth , and health . RESULTS . The trial was ab and oned well short of its target sample size because of recruitment difficulties . Seventy infants were recruited from 11 centers , 35 in each group : 59 survived to 2 years of age , and 58 ( 98 % ) were assessed at follow-up , but data for cerebral palsy were available for only 56 survivors . There was little evidence for a difference in the major end point , the rate of the combined outcome of death , or major disability at 2 years of age ( dexamethasone group : 46 % ; controls : 43 % ) . Rates of mortality before follow-up ( 11 % vs 20 % ) , major disability ( 41 % vs 31 % ) , cerebral palsy ( 14 % vs 22 % ) , or of the combined outcomes of death or cerebral palsy ( 23 % vs 37 % ) were not substantially different between the groups . There were no obvious effects of low-dose dexamethasone on growth or readmissions to hospital after discharge . CONCLUSIONS . Although this trial was not able to provide definitive evidence on the long-term effects of low-dose dexamethasone after the first week of life in chronically ventilator-dependent infants , our data indicate no strong association with long-term morbidity Objective . To evaluate the effectiveness of nebulized pentoxifylline ( PTXF ) compared to intravenous dexamethasone ( DX ) or placebo ( nebulized distilled water ) for the prevention of bronchopulmonary dysplasia ( BPD ) . Methods . One hundred and fifty very low birth weight infants were r and omly assigned to three groups . Entry criteria were the need for oxygen administration on the fourth day of life , irrespective of whether ventilatory support was required . PTXF was administered with a nebulizer every 6 hours on three consecutive days ( a single course ) in a dose of 20 mg/kg when infants were breathing spontaneously or 10 mg/kg when they needed ventilatory support . DX was given every 12 hours on three consecutive days in a dose of 0.25 mg/kg . Nebulized distilled water was administered with the schedule of inhalation as in the PTXF group . When the need for ventilatory support or oxygen dependency persisted , the course of both drugs and placebo administration was repeated every seven days until the diagnosis of BPD was established . Results . Both PTXF and DX reduced the incidence of disease when compared with placebo . The respective data obtained for the PTXF-group versus the placebo group were as follows : difference in risk , 27 % ; OR : 0.32 ; CI : 0.11–0.94 ; p = 0.039 ; whereas the results for the DX-group versus the placebo group were : difference in risk , − 23 % ; OR : 0.39 ; CI : 0.14–1.14 ; p = 0.07 . Conclusion . Our data show that nebulized PTXF reduces the risk of BPD and may be a potential alternative to steroids in the prevention of this disease In order to assess the efficacy of a combination of systemic and nebulized corticosteroids in reducing the incidence and severity of chronic lung disease ( CLD ) in very low birthweight ( VLBW ) infants , 60 ventilator‐dependent infants ≤ 1500 g were r and omly assigned to receive either steroids or placebo as of 7d . The steroid group ( n= 30 , GA = 25:8 ± 1:6 weeks , BW = 731 ± 147 g ) received systemic dexamethasone for 3 d , followed by nebulized budesonide for 18 d. Control infants ( n= 30 , GA = 25:9 ± 1.8 weeks , BW = 796 ± 199 g ) received systemic and inhaled saline . Steroid‐treated infants required less ventilatory support between 9 and 17 d ( p < 0:01 ) , and had greater lung compliance at 10 d ( p= 0:01 ) , but not subsequently . CLD incidence at 36 weeks was 45.5 % vs 56.0 % in controls , and fewer steroid‐treated infants required dexamethasone rescue ( 23.3 % vs 56.7 % , p= 0:017 ) . Survival to discharge was similar ( 73.3 % vs 83.3 % ) , as were the duration s of mechanical ventilation , supplemental oxygen use , and hospitalization . Tracheal effluent elastase/albumin ratios and serum cortisol values did not differ between groups , and no adverse effects were noted . We conclude that early dexamethasone administration was associated with improved pulmonary function , which was not sustained with nebulized budesonide . However , the steroid regimen studied reduced the need for dexamethasone rescue in infants with CLD Background . Infection is a major complication of preterm infants , result ing in increased morbidity and mortality . We recently reported the results of a multicenter trial of dexamethasone initiated at 14 or 28 days in very low birth weight ( VLBW ) infants who were at risk for chronic lung disease ; the results showed an increase in nosocomial bacteremia in the group receiving dexamethasone . This study is an in-depth analysis of bacteremia/sepsis and meningitis among infants enrolled in the trial . Methods . Data on cultures performed and antibiotic therapy were collected prospect ively . Infections were classified as definite or possible/ clinical . Results . A total of 371 infants were enrolled in the trial . There were no baseline differences in risk factors for infection . For the first 14 days of study , infants received either dexamethasone ( group I , 182 ) or placebo ( group II , 189 ) . During this period , infants in group I were significantly \n Output:\n " }, { "from": "agent", "value": "Higher cumulative dexamethasone doses administered after the first week of life may decrease the risk for bronchopulmonary dysplasia without increasing the risk for neurodevelopmental sequelae in ventilated preterm infants ." } ]

[ { "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: Parkinson plus diseases , comprising mainly progressive supranuclear palsy ( PSP ) and multiple system atrophy ( MSA ) are rare neurodegenerative conditions . We design ed a double-blind r and omized placebo-controlled trial of riluzole as a potential disease-modifying agent in Parkinson plus disorders ( NNIPPS : Neuroprotection and Natural History in Parkinson Plus Syndromes ) . We analysed the accuracy of our clinical diagnostic criteria , and studied prognostic factors for survival . Patients with an akinetic-rigid syndrome diagnosed as having PSP or MSA according to modified consensus diagnostic criteria were considered for inclusion . The psychometric validity ( convergent and predictive ) of the NNIPPS diagnostic criteria were tested prospect ively by clinical and pathological assessment s. The study was powered to detect a 40 % decrease in relative risk of death within PSP or MSA strata . Patients were r and omized to riluzole or matched placebo daily and followed up to 36 months . The primary endpoint was survival . Secondary efficacy outcomes were rates of disease progression assessed by functional measures . A total of 767 patients were r and omized and 760 qualified for the Intent to Treat ( ITT ) analysis , stratified at entry as PSP ( 362 patients ) or MSA ( 398 patients ) . Median follow-up was 1095 days ( range 249–1095 ) . During the study , 342 patients died and 112 brains were examined for pathology . NNIPPS diagnostic criteria showed for both PSP and MSA excellent convergent validity with the investigators ’ assessment of diagnostic probability ( point-biserial correlation : MSA rpb = 0.93 , P < 0.0001 ; PSP , rpb = 0.95 , P < 0.0001 ) , and excellent predictive validity against histopathology [ sensitivity and specificity ( 95 % CI ) for PSP 0.95 ( 0.88–0.98 ) and 0.84 ( 0.77–0.87 ) ; and for MSA 0.96 ( 0.88–0.99 ) and 0.91 ( 0.86–0.93 ) ] . There was no evidence of a drug effect on survival in the PSP or MSA strata ( 3 year Kaplan – Meier estimates PSP-riluzole : 0.51 , PSP-placebo : 0.50 ; MSA-riluzole : 0.53 , MSA-placebo : 0.58 ; P = 0.66 and P = 0.48 by the log-rank test , respectively ) , or in the population as a whole ( P = 0.42 , by the stratified-log-rank test ) . Likewise , rate of progression was similar in both treatment groups . There were no unexpected adverse effects of riluzole , and no significant safety concerns . Riluzole did not have a significant effect on survival or rate of functional deterioration in PSP or MSA , although the study reached over 80 % power to detect the hypothesized drug effect within strata . The NNIPPS diagnostic criteria were consistent and valid . They can be used to distinguish between PSP and MSA with high accuracy , and should facilitate research into these conditions relatively early in their evolution Background : The pleiotropic effects of riluzole may antagonize common mechanisms underlying chronic cerebellar ataxia , a debilitating and untreatable consequence of various diseases . Methods : In a r and omized , double-blind , placebo-controlled pilot trial , 40 patients presenting with cerebellar ataxias of different etiologies were r and omly assigned to riluzole ( 100 mg/day ) or placebo for 8 weeks . The following outcome measures were compared : proportion of patients with a decrease of at least 5 points in the International Cooperative Ataxia Rating Scale ( ICARS ) total score after 4 and 8 weeks compared with the baseline score ; mean changes from the baseline to posttreatment ICARS ( total score and subscores at 8 weeks ) ; and occurrence of adverse events . Results : Riluzole and placebo groups did not differ in baseline characteristics . The number of patients with a 5-point ICARS drop was significantly higher in the riluzole group than in the placebo group after 4 weeks ( 9/19 vs 1/19 ; odds ratio [ OR ] = 16.2 ; 95 % confidence interval [ CI ] 1.8–147.1 ) and 8 weeks ( 13/19 vs 1/19 ; OR = 39.0 ; 95 % CI 4.2–364.2 ) . The mean change in the riluzole group ICARS after treatment revealed a decrease ( p < 0.001 ) in the total score ( −7.05 [ 4.96 ] vs 0.16 [ 2.65 ] ) and major subscores ( −2.11 [ 2.75 ] vs 0.68 [ 1.94 ] for static function , −4.11 [ 2.96 ] vs 0.37 [ 2.0 ] for kinetic function , and −0.74 [ 0.81 ] vs 0.05 [ 0.40 ] for dysarthria ) . Sporadic , mild adverse events occurred . Conclusions : These findings indicate the potential effectiveness of riluzole as symptomatic therapy in diverse forms of cerebellar ataxia . Classification of evidence : This study provides Class I evidence that riluzole reduces , by at least 5 points , the ICARS score in patients with a wide range of disorders that cause cerebellar ataxia ( risk difference 63.2 % , 95 % CI 33.5%–79.9 % ) We conducted a r and omized double‐blind trial of riluzole in Huntington 's disease to investigate the efficacy of this antiexcitotoxic drug in slowing disease progression Background : Riluzole retards striatal glutamate release and pathologic consequences in neurotoxic animal models of Huntington ’s disease ( HD ) . Objective : To determine the dosage-related impact of riluzole on chorea in HD . Methods : An 8-week double-blind dose-ranging multicenter study of riluzole was conducted in 63 subjects ( 32 women , 31 men ) with HD who were r and omized to receive placebo , riluzole 100 mg/day , or riluzole 200 mg/day . The prespecified outcome measure was change in the total maximal chorea score of the Unified Huntington ’s Disease Rating Scale ( UHDRS ) . Results : Fifty-six ( 89 % ) subjects completed the study . A reduction ( p < 0.01 ) in chorea at 8 weeks was found using a linear trend test with dose . Comparing the groups individually , the reduction in chorea for the riluzole 200-mg/day group ( −2.2 ± 3.3 ) was different ( p = 0.01 ) from placebo ( + 0.7 ± 3.4 ) , but the riluzole 100-mg/day group ( −0.2 ± 2.9 ) was not . Riluzole did not improve other motor , cognitive , behavioral , or functional components of the UHDRS . Alanine aminotransferase was elevated in a dosage-dependent fashion ( p = 0.01 ) . Conclusions : Over 8 weeks of treatment , riluzole 200 mg/day ameliorated chorea intensity in HD without improving functional capacity or other clinical features of illness . Riluzole 200 mg/day was attended by reversible liver transaminase abnormalities that would require monitoring in long-term studies The objective of this study was to evaluate the effect of riluzole on dyskinesia and the duration of the ON state in patients with Parkinson disease ( PD ) . The authors studied 16 PD patients with levodopa-induced dyskinesia . All patients initially received an apomorphine dose intended to induce the motor function benefit ( ON state ) generally accompanied by dyskinesia . They evaluated the patients during the OFF and ON states using the UPDRS-III , UPDRS-IV , and Larsen scales , and measured the duration of the ON state . Patients were r and omly assigned to receive either riluzole ( 50 mg bid ) or placebo for 7 consecutive days ( 8 patients in each group ) . The authors did not interrupt previously prescribed medication . Following the 7-day period , they carried out similar evaluation procedures before and after another apomorphine challenge . Mean UPDRS-IV scores were 6.1 points and 6.0 points before and after riluzole therapy respectively . For the placebo group , the scores were 6.9 points and 6.6 points for the initial and final evaluations respectively . Larsen scale had mean scores of 9.2 points and 9.9 points for the pre- and postriluzole periods , and 10.2 points and 9.6 points for pre- and post-placebo evaluations respectively . The ON state was 33.5 % lengthier after 7 days of riluzole and 28.0 % lengthier after placebo . They could not find any statistical differences between the 2 groups . Short-term riluzole administration in PD patients was not able to reduce apomorphine-induced dyskinesia but could extend the ON state duration , although this did not reach statistical significance BACKGROUND To the extent that excitotoxicity may play a role in the pathogenesis of certain neurodegenerative disorders , antagonists of glutamate , an excitatory neurotransmitter , should exert neuroprotective effects in these disorders , including Parkinson 's disease ( PD ) . METHODS Patients in early stages of PD , not previously treated with levodopa , were r and omized to receive riluzole 50 mg capsules orally , taken twice daily or a matching placebo . All subjects were evaluated at baseline ( pre-treatment ) , at 1 , 3 and 6 months ( post-treatment ) , and following a 6-week washout . After the washout , all subjects were offered an enrollment in an open label , 1-year , extension study . The principal investigator ( JJ ) , however , remained blinded to the original assignment during the entire study . The patients were assessed by the Unified Parkinson 's Disease Rating Scale ( UPDRS ) , Activities of Daily Living ( ADL ) , Hoehn & Yahr ( HY ) stage , and Schwab and Engl and ( SE ) ADL scale . The quantitative assessment s included Movement Time ( MT ) and Reaction Time ( RT ) . Additionally , the time to initiate dopaminergic therapy was assessed . Safety was determined at each visit by clinical history and examination , a panel of blood safety laboratory tests including complete blood count , chemistry profile , and liver function studies . RESULTS Twenty patients with a mean age of 62+/-9.02 ( range : 46 - 73 ) years and mean duration of symptoms of 18+/-9.53 ( range : 6 - 36 ) months were enrolled . One patient withdrew from the study because he needed more aggressive treatment of his symptoms . Analysis of the efficacy variables showed no meaningful symptomatic effect of riluzole on UPDRS score . Likewise , there was no significant change in the median HY stage , SE ADL rating , or the MT/RT . Seventeen patients ( mean age 62+/-9.26 ) elected to continue in the open label extension study . Although the observed deterioration in UPDRS scores seemed to be more pronounced in the placebo group than in the riluzole group , the difference did not reach statistical significance . There was no statistically significant difference in the latency between enrollment and start of symptomatic therapy when patients initially treated with riluzole were compared to those initially treated with placebo ( 8.3 vs 9 months ) . CONCLUSIONS This pilot and extension study showed that riluzole , 100mg/day , was well tolerated in patients with early PD . No evidence of symptomatic effect of riluzole was observed . Because of the exploratory nature of the design and small size of the study , it was not possible to determine whether riluzole affected the natural history of PD . The encouraging results from our study , however , suggest that larger , longitudinal studies are warranted BACKGROUND Our previous study in patients with cerebellar ataxias of different causes showed significant benefit of riluzole after 8 weeks . We aim ed to confirm these results in patients with spinocerebellar ataxia or Friedreich 's ataxia in a 1-year trial . METHODS Patients with spinocerebellar ataxia or Friedreich 's ataxia ( 2:1 ratio ) from three Italian neurogenetic units were enrolled in this multicentre , double-blind , placebo-controlled trial , and r and omly assigned to riluzole ( 50 mg orally , twice daily ) or placebo for 12 months . The r and omisation list was computer-generated and a central ised r and omisation system was implemented . Participants and assessing neurologists were masked to treatment allocation . The primary endpoint was the proportion of patients with improved Scale for the Assessment and Rating of Ataxia ( SARA ) score ( a drop of at least one point ) at 12 months . An intention-to-treat analysis was done . This trial is registered at Clinical Trials.gov , number NCT01104649 . FINDINGS Between May 22 , 2010 , and Feb 25 , 2013 , 60 patients were enrolled . Two patients in the riluzole group and three in the placebo group withdrew their consent before receiving treatment , so the intention-to-treat analysis was done on 55 patients ( 19 with spinocerebellar ataxia and nine with Friedreich 's ataxia in the riluzole group , and 19 with spinocerebellar ataxia and eight with Fried \n Output:\n " }, { "from": "agent", "value": "No significant difference was found in the number of participants with adverse events but with motor improvement in hereditary ataxia .\nRiluzole is well-tolerated in the patients with neurodegenerative movement disorders .\nMoreover , it makes sense to design long-term study focusing on neuroprotective effect of riluzole in disease-modifying" } ]

[ { "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 psychological consequences among family members given the option to be present during the CPR of a relative , compared with those not routinely offered the option . Methods Prospect i ve , cluster-r and omized , controlled trial involving 15 prehospital emergency medical services units in France , comparing systematic offer for a relative to witness CPR with the traditional practice among 570 family members . Main outcome measure was 1-year assessment included proportion suffering post-traumatic stress disorder ( PTSD ) , anxiety and depression symptoms , and /or complicated grief . Results Among the 570 family members [ intention to treat ( ITT ) population ] , 408 ( 72 % ) were evaluated at 1 year . In the ITT population ( N = 570 ) , family members had PTSD-related symptoms significantly more frequently in the control group than in the intervention group [ adjusted odds ratio , 1.8 ; 95 % confidence interval ( CI ) 1.1–3.0 ; P = 0.02 ] as did family members to whom physicians did not propose witnessing CPR [ adjusted odds ratio , 1.7 ; 95 % CI 1.1–2.6 ; P = 0.02 ] . In the observed cases population ( N = 408 ) , the proportion of family members experiencing a major depressive episode was significantly higher in the control group ( 31 vs. 23 % ; P = 0.02 ) and among family members to whom physicians did not propose the opportunity to witness CPR ( 31 vs. 24 % ; P = 0.03 ) . The presence of complicated grief was significantly greater in the control group ( 36 vs. 21 % ; P = 0.005 ) and among family members to whom physicians did not propose the opportunity to witness resuscitation ( 37 vs. 23 % ; P = 0.003 ) . Conclusions At 1 year after the event , psychological benefits persist for those family members offered the possibility to witness the CPR of a relative in cardiac arrest BACKGROUND Family presence during resuscitation ( FPDR ) is supported by patients and their family members . Nurses , however , including critical care nurses who frequently implement resuscitative care , have mixed views . OBJECTIVES To determine the impact of online learning on critical care nurses ' perception of and self-confidence with FPDR . METHODS A 2-group , r and om assignment , pretest and posttest quasi-experimental study was conducted with critical care nurses recruited nationally . An online learning module on FPDR was developed and administered to the intervention group . Perceptions and self-confidence for FPDR were measured by using the Family Presence Risk- Benefit Scale ( FPR-BS ) and the Family Presence Self-confidence Scale ( FPS-CS ) . Two-factor , mixed-model factorial analysis of variance was used to compare mean scores . RESULTS A total of 74 critical care nurses participated in the study . Mean FPR-BS and FPS-CS scores were significantly greater in the intervention group than in the control group . For the intervention group , mean scores on the FPR-BS increased from 3.63 to 4.07 ( P < .001 ) and on the FPS-CS increased from 4.24 to 4.57 ( P < .001 ) , signifying improved perception and self-confidence . Scores did not change significantly in the control group : mean FPR-BS score increased from 3.82 to 3.88 ( P = .23 ) and the mean FPS-CS score of 4.40 did not change ( P > .99 ) . CONCLUSIONS Online learning is a feasible and effective method for educating large numbers of critical care nurses about FPDR . Online learning can improve perceptions and self-confidence related to FPDR , which may promote more widespread adoption of FPDR into practice BACKGROUND Increasingly , patients ' families are remaining with them during cardiopulmonary resuscitation and invasive procedures , but this practice remains controversial and little is known about the practice s of critical care and emergency nurses related to family presence . OBJECTIVE To identify the policies , preferences , and practice s of critical care and emergency nurses for having patients ' families present during resuscitation and invasive procedures . METHODS A 30-item survey was mailed to a r and om sample of 1500 members of the American Association of Critical-Care Nurses and 1500 members of the Emergency Nurses Association . RESULTS Among the 984 respondents , 5 % worked on units with written policies allowing family presence during both resuscitation and invasive procedures and 45 % and 51 % , respectively , worked on units that allowed it without written policies during resuscitation or during invasive procedures . Some respondents preferred written policies allowing family presence ( 37 % for resuscitation , 35 % for invasive procedures ) , whereas others preferred unwritten policies allowing it ( 39 % for resuscitation , 41 % for invasive procedures ) , Many respondents had taken family members to the bedside ( 36 % for resuscitation , 44 % for invasive procedure ) or would do so in the future ( 21 % for resuscitation , 18 % for invasive procedures ) , and family members often asked to be present ( 31 % for resuscitation , 61 % for invasive procedures ) . CONCLUSIONS Nearly all respondents have no written policies for family presence yet most have done ( or would do ) it , prefer it be allowed , and are confronted with requests from family members to be present . Written policies or guidelines for family presence during resuscitation and invasive procedures are recommended BACKGROUND The effect of family presence during cardiopulmonary resuscitation ( CPR ) on the family members themselves and the medical team remains controversial . METHODS We enrolled 570 relatives of patients who were in cardiac arrest and were given CPR by 15 prehospital emergency medical service units . The units were r and omly assigned either to systematic ally offer the family member the opportunity to observe CPR ( intervention group ) or to follow st and ard practice regarding family presence ( control group ) . The primary end point was the proportion of relatives with post-traumatic stress disorder (PTSD)-related symptoms on day 90 . Secondary end points included the presence of anxiety and depression symptoms and the effect of family presence on medical efforts at resuscitation , the well-being of the health care team , and the occurrence of medicolegal cl aims . RESULTS In the intervention group , 211 of 266 relatives ( 79 % ) witnessed CPR , as compared with 131 of 304 relatives ( 43 % ) in the control group . In the intention-to-treat analysis , the frequency of PTSD-related symptoms was significantly higher in the control group than in the intervention group ( adjusted odds ratio , 1.7 ; 95 % confidence interval [ CI ] , 1.2 to 2.5 ; P=0.004 ) and among family members who did not witness CPR than among those who did ( adjusted odds ratio , 1.6 ; 95 % CI , 1.1 to 2.5 ; P=0.02 ) . Relatives who did not witness CPR had symptoms of anxiety and depression more frequently than those who did witness CPR . Family-witnessed CPR did not affect resuscitation characteristics , patient survival , or the level of emotional stress in the medical team and did not result in medicolegal cl aims . CONCLUSIONS Family presence during CPR was associated with positive results on psychological variables and did not interfere with medical efforts , increase stress in the health care team , or result in medicolegal conflicts . ( Funded by Programme Hospitalier de Recherche Clinique 2008 of the French Ministry of Health ; Clinical Trials.gov number , NCT01009606 . ) OBJECTIVE . When a child presents to a trauma center with a serious injury , family members are often excluded from the initial trauma team evaluation . The objective of this study was to evaluate the outcomes of a structured program of family presence during pediatric trauma team activations by measuring ( 1 ) the need for termination of family presence , ( 2 ) times to completion of key parts of the trauma evaluation , and ( 3 ) the opinions of staff surveyed immediately after conclusion of family presence . METHODS . This was a cross-sectional study that combined prospect ively obtained data and surveys from trauma team evaluations in which family presence occurred , with retrospective chart review of all trauma activations during an 18-month study period . The study was conducted at a level 1 pediatric trauma center with a preestablished family presence program that assigns a staff member to screen family members for family presence , provide support , and record events . Times to completion of key components of the trauma evaluation were calculated and compared for cases with and without family presence . Cross-sectional surveys were performed immediately after each trauma team evaluation . RESULTS . A total of 197 family members participated in family presence . There were no cases of interference with medical care by family members . Seven family members were asked to leave the trauma area by staff after initiation of family presence for various reasons . Times to completion of key components of the trauma evaluation did not differ significantly between enrolled patients with family presence and those without family presence . Surveys were completed for 136 cases , and the majority of providers reported that family presence either had no effect on or improved medical decision-making ( 97 % ) , institution of patient care ( 94 % ) , communication among providers ( 92 % ) , and communication with family members ( 98 % ) . CONCLUSIONS . This prospect i ve study suggests that there is an overall low prevalence of negative outcomes associated with family presence during pediatric trauma team evaluation after implementation of a structured family presence program . Excluding family members as a routine because of provider concerns about negative impact on clinical care does not seem to be indicated \n Output:\n " }, { "from": "agent", "value": "Study findings demonstrated educational interventions can improve support for FPDR , as well as intent to offer it as an option ." } ]

[ { "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 We sought to determine whether structured exercise training ( ET ) improves maximal exercise capacity , left ventricular diastolic function , and quality of life ( QoL ) in patients with heart failure with preserved ejection fraction ( HFpEF ) . BACKGROUND Nearly one-half of patients with heart failure experience HFpEF , but effective therapeutic strategies are sparse . METHODS A total of 64 patients ( age 65 ± 7 years , 56 % female ) with HFpEF were prospect ively r and omized ( 2:1 ) to supervised endurance/resistance training in addition to usual care ( ET , n = 44 ) or to usual care alone ( UC ) ( n = 20 ) . The primary endpoint was the change in peak Vo(2 ) after 3 months . Secondary endpoints included effects on cardiac structure , diastolic function , and QoL. RESULTS Peak Vo(2 ) increased ( 16.1 ± 4.9 ml/min/kg to 18.7 ± 5.4 ml/min/kg ; p < 0.001 ) with ET and remained unchanged ( 16.7 ± 4.7 ml/min/kg to 16.0 ± 6.0 ml/min/kg ; p = NS ) with UC . The mean benefit of ET was 3.3 ml/min/kg ( 95 % confidence interval [ CI ] : 1.8 to 4.8 , p < 0.001 ) . E/e ' ( mean difference of changes : -3.2 , 95 % CI : -4.3 to -2.1 , p < 0.001 ) and left atrial volume index ( milliliters per square meter ) decreased with ET and remained unchanged with UC ( -4.0 , 95 % CI : -5.9 to -2.2 , p < 0.001 ) . The physical functioning score ( 36-Item Short-Form Health Survey ) improved with ET and remained unchanged with UC ( 15 , 95 % CI : 7 to 24 , p < 0.001 ) . The ET-induced decrease of E/e ' was associated with 38 % gain in peak Vo(2 ) and 50 % of the improvement in physical functioning score . CONCLUSIONS Exercise training improves exercise capacity and physical dimensions of QoL in HFpEF . This benefit is associated with atrial reverse remodeling and improved left ventricular diastolic function . ( Exercise Training in Diastolic Heart Failure-Pilot Study : A Prospect i ve , R and omised , Controlled Study to Determine the Effects of Physical Training on Exercise Capacity and Quality of Life [ Ex-DHF-P ] ; IS RCT N42524037 ) Background —Heart failure ( HF ) with preserved left ventricular ejection fraction ( HFPEF ) is the most common form of HF in the older population . Exercise intolerance is the primary chronic symptom in patients with HFPEF and is a strong determinant of their reduced quality of life ( QOL ) . Exercise training ( ET ) improves exercise intolerance and QOL in patients with HF with reduced ejection fraction ( EF ) . However , the effect of ET in HFPEF has not been examined in a r and omized controlled trial . Methods and Results —This 16-week investigation was a r and omized , attention-controlled , single-blind study of medically supervised ET ( 3 days per week ) on exercise intolerance and QOL in 53 elderly patients ( mean age , 70±6 years ; range , 60 to 82 years ; women , 46 ) with isolated HFPEF ( EF ≥50 % and no significant coronary , valvular , or pulmonary disease ) . Attention controls received biweekly follow-up telephone calls . Forty-six patients completed the study ( 24 ET , 22 controls ) . Attendance at exercise sessions in the ET group was excellent ( 88 % ; range , 64 % to 100 % ) . There were no trial-related adverse events . The primary outcome of peak exercise oxygen uptake increased significantly in the ET group compared to the control group ( 13.8±2.5 to 16.1±2.6 mL/kg per minute [ change , 2.3±2.2 mL/kg per minute ] versus 12.8±2.6 to 12.5±3.4 mL/kg per minute [ change , −0.3±2.1 mL/kg per minute ] ; P=0.0002 ) . There were significant improvements in peak power output , exercise time , 6-minute walk distance , and ventilatory anaerobic threshold ( all P<0.002 ) . There was improvement in the physical QOL score ( P=0.03 ) but not in the total score ( P=0.11 ) . Conclusions —ET improves peak and submaximal exercise capacity in older patients with HFPEF . Clinical Trial Registration —URL : http://www . clinical trials.gov . Unique identifier : NCT01113840 BACKGROUND The health benefits of leisure-time physical activity are well known , but whether less exercise than the recommended 150 min a week can have life expectancy benefits is unclear . We assessed the health benefits of a range of volumes of physical activity in a Taiwanese population . METHODS In this prospect i ve cohort study , 416,175 individuals ( 199,265 men and 216,910 women ) participated in a st and ard medical screening programme in Taiwan between 1996 and 2008 , with an average follow-up of 8·05 years ( SD 4·21 ) . On the basis of the amount of weekly exercise indicated in a self-administered question naire , participants were placed into one of five categories of exercise volumes : inactive , or low , medium , high , or very high activity . We calculated hazard ratios ( HR ) for mortality risks for every group compared with the inactive group , and calculated life expectancy for every group . FINDINGS Compared with individuals in the inactive group , those in the low-volume activity group , who exercised for an average of 92 min per week ( 95 % CI 71 - 112 ) or 15 min a day ( SD 1·8 ) , had a 14 % reduced risk of all-cause mortality ( 0·86 , 0·81 - 0·91 ) , and had a 3 year longer life expectancy . Every additional 15 min of daily exercise beyond the minimum amount of 15 min a day further reduced all-cause mortality by 4 % ( 95 % CI 2·5 - 7·0 ) and all-cancer mortality by 1 % ( 0·3 - 4·5 ) . These benefits were applicable to all age groups and both sexes , and to those with cardiovascular disease risks . Individuals who were inactive had a 17 % ( HR 1·17 , 95 % CI 1·10 - 1·24 ) increased risk of mortality compared with individuals in the low-volume group . INTERPRETATION 15 min a day or 90 min a week of moderate-intensity exercise might be of benefit , even for individuals at risk of cardiovascular disease . FUNDING Taiwan Department of Health Clinical Trial and Research Center of Excellence and National Health Research Institutes Exercise training improves functional capacity in patients with exercise limitation attributed to systolic dysfunction ( SD ) , but exercise training effects in patients with diastolic dysfunction is unclear . The authors determined the functional capacity , quality of life , and echocardiography responses of heart failure with preserved ejection fraction ( HFpEF ) patients to 16 weeks exercise training . Thirty patients with HFpEF were r and omized to an exercise training or non-exercising control group . The patients had a baseline mean age of 64 ± 8 years , left ventricular ejection fraction 57 % ± 10 % , and peak oxygen consumption ( peak VO(2 ) ) of 13.3 ± 3.8 mL O(2 ) /kg/min . Minnesota Living With Heart Failure and Hare-Davis scores and echocardiographic measures ( ejection fraction , systolic and diastolic tissue velocity and filling pressure [ E/E ' ] ) were performed at baseline and after 16 weeks of exercise training . The exercise training and non-exercising control groups showed similar baseline VO(2 ) ( 12.2 ± 3.6 mL/kg/min vs 14.1 ± 4.1 mL/kg/min ) , ejection fraction ( 58 % ± 13 % vs 57 % ± 8 % ) , and systolic and diastolic function . After exercise training the increment in peak VO(2 ) in the exercise training group was ( 24.6 % , P=.02 ) , and the non-exercising control group ( 5.1 % , P=.19 ) . V(E ) /VCO(2 ) slope was reduced by 12.7 % in the exercise training group ( P=.02 ) but was unchanged in the non-exercising control group ( P=.03 ) . No significant changes in diastolic or systolic function were noted in either group . Quality -of-life and depression scores were unchanged with exercise training . Changes in peak VO(2 ) and V(E ) /VCO(2 ) slope were unrelated to measures of diastolic and systolic function . In patients with exercise limitation attributed to HFpEF , the improvement in peak VO(2 ) with exercise training was not clearly related to changes in cardiac function 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 Heart failure with preserved ejection fraction ( HFpEF ) is a major cause of morbidity and mortality . Exercise training is an established adjuvant therapy in heart failure ; however , the effects of high-intensity interval training ( HIIT ) in HFpEF are unknown . We compared the effects of HIIT vs. moderate-intensity aerobic continuous training ( MI-ACT ) on peak oxygen uptake ( V̇o₂peak ) , left ventricular diastolic dysfunction , and endothelial function in patients with HFpEF . Nineteen patients with HFpEF ( age 70 ± 8.3 yr ) were r and omized to either HIIT ( 4 × 4 min at 85 - 90 % peak heart rate , with 3 min active recovery ) or MI-ACT ( 30 min at 70 % peak heart rate ) . Fifteen patients completed exercise training ( HIIT : n = 9 ; MI-ACT : n = 6 ) . Patients trained 3 days/wk for 4 wk . Before and after training patients underwent a treadmill test for V̇o₂peak determination , 2D-echocardiography for assessment of left ventricular diastolic dysfunction , and brachial artery flow-mediated dilation ( FMD ) for assessment of endothelial function . HIIT improved V̇o₂peak ( pre = 19.2 ± 5.2 ml·kg(-1)·min(-1 ) ; post = 21.0 ± 5.2 ml·kg(-1)·min(-1 ) ; P = 0.04 ) and left ventricular diastolic dysfunction grade ( pre = 2.1 ± 0.3 ; post = 1.3 ± 0.7 ; P = 0.02 ) , but FMD was unchanged ( pre = 6.9 ± 3.7 % ; post = 7.0 ± 4.2 % ) . No changes were observed following MI-ACT . A trend for reduced left atrial volume index was observed following HIIT compared with MI-ACT ( -3.3 ± 6.6 vs. + 5.8 ± 10.7 ml/m(2 \n Output:\n " }, { "from": "agent", "value": "There were significant improvements in peak oxygen uptake , 6-min walking test distance , and ventilatory threshold , whereas quality of life and echocardiographic parameters improved only in some studies .\nEndothelial function/arterial stiffness remained unchanged .\nNo adverse events were reported .\nAppropriate exercise programs are able to get a favorable cardiovascular outcome in patients with HFpEF .\nThis could also benefit in terms of quality of life , even if more controversial ." } ]

[ { "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 — Ultrasound of carotid arteries provides measures of intima media thickness ( IMT ) and plaque , both widely used as surrogate measures of cardiovascular disease . Although IMT and plaques are highly intercorrelated , the relationship between carotid plaque and IMT and cardiovascular disease has been conflicting . In this prospect i ve , population -based study , we measured carotid IMT , total plaque area , and plaque echogenicity as predictors for first-ever myocardial infa rct ion ( MI ) . Methods — IMT , total plaque area , and plaque echogenicity were measured in 6226 men and women aged 25 to 84 years with no previous MI . The subjects were followed for 6 years and incident MI was registered . Results — During follow-up , MI occurred in 6.6 % of men and 3.0 % of women . The adjusted relative risk ( RR ; 95 % CI ) between the highest plaque area tertile versus no plaque was 1.56 ( 1.04 to 2.36 ) in men and 3.95 ( 2.16 to 7.19 ) in women . In women , there was a significant trend toward a higher MI risk with more echolucent plaque . The adjusted RR ( 95 % CI ) in the highest versus lowest IMT quartile was 1.73 ( 0.98 to 3.06 ) in men and 2.86 ( 1.07 to 7.65 ) in women . When we excluded bulb IMT from analyses , IMT did not predict MI in either sex . Conclusions — In a general population , carotid plaque area was a stronger predictor of first-ever MI than was IMT . Carotid atherosclerosis was a stronger risk factor for MI in women than in men . In women , the risk of MI increased with plaque echolucency Abstract — Plasma levels of C-reactive protein ( CRP , a marker of the reactant plasma protein component of the inflammatory response ) and of fibrin D-dimer ( a marker of cross-linked fibrin turnover ) have each been associated in recent studies with the risk of future ischemic heart disease ( IHD ) . Previous experimental studies have shown that fibrin degradation products , including D-dimer , have effects on inflammatory processes and acute-phase protein responses . In the Speedwell Prospect i ve Study , we therefore measured CRP and D-dimer levels in stored plasma sample s from 1690 men aged 49 to 67 years who were followed-up for incident IHD for an average of 75±4 months ( mean±SD ) and studied their associations with each other , with baseline and incident IHD , and with IHD risk factors . CRP and D-dimer levels were each associated with age , plasma fibrinogen , smoking habit , and baseline evidence of IHD . CRP was associated with D-dimer ( r = 0.21 , P < 0.00001 ) . On univariate analyses , both CRP and D-dimer were associated with incident IHD . The incidence of IHD increased with CRP independently of the level of D-dimer ( P = 0.0002 ) and also increased with D-dimer independently of the level of CRP ( P = 0.048 ) . In multivariate analyses , inclusion of D-dimer and conventional risk factors reduced the strength of the association between CRP and incident IHD ; likewise , inclusion of CRP and conventional risk factors reduced the strength of the association between D-dimer and incident IHD . We conclude that although these respective markers of inflammation and fibrin turnover show modest association with each other in middle-aged men , they may have additive associations with risk of incident IHD . Further larger studies are required to test this hypothesis BACKGROUND A high serum total homocysteine ( tHcy ) concentration is a risk factor for death , but the strength of the relation in patients with type 2 ( non-insulin-dependent ) diabetes mellitus compared with nondiabetic subjects is not known . A cross-sectional study suggested that the association between tHcy and cardiovascular disease is stronger in diabetic than in nondiabetic subjects . We therefore prospect ively investigated the combined effect of hyperhomocysteinemia and type 2 diabetes on mortality . METHODS AND RESULTS Between October 1 , 1989 , and December 31 , 1991 , serum was saved from 2484 men and women , 50 to 75 years of age , who were r and omly selected from the town of Hoorn , The Netherl and s. Fasting serum tHcy concentration was measured in 171 subjects who died ( cases ; 76 of cardiovascular disease ) and in a stratified r and om sample of 640 survivors ( control subjects ) . Mortality risks were calculated over 5 years of follow-up by means of logistic regression . The prevalence of hyperhomocysteinemia ( tHcy > 14 micromol/L ) was 25 . 8 % . After adjustment for major cardiovascular risk factors , serum albumin , and HbA(1c ) , the odds ratio ( 95 % CI ) for 5-year mortality was 1.56 ( 1.07 to 2.30 ) for hyperhomocysteinemia and 1.26 ( 1.02 to 1 . 55 ) per 5-micromol/L increment of tHcy . The odds ratio for 5-year mortality for hyperhomocysteinemia was 1.34 ( 0.87 to 2.06 ) in nondiabetic subjects and 2.51 ( 1.07 to 5.91 ) in diabetic subjects ( P=0.08 for interaction ) . CONCLUSIONS Hyperhomocysteinemia is related to 5-year mortality independent of other major risk factors and appears to be a stronger ( 1.9-fold ) risk factor for mortality in type 2 diabetic patients than in nondiabetic subjects In this nested case-control study , lipoprotein ( a ) [ Lp(a ) ] concentrations and apo(a ) isoform size were measured in serum sample s obtained from men participating in the prospect i ve Multiple Risk Factor Intervention Trial ( MRFIT ) . Serum from men aged 35 to 57 years and stored for up to 20 years were analyzed for Lp(a ) levels ( n=736 ) and isoform size ( n=487 ) , respectively . Cases involved nonfatal myocardial infa rct ions ( MI ; n=98 ) , documented during the active phase of the study that ended on February 28 , 1982 and coronary heart disease ( CHD ) deaths ( n=148 ) monitored through 1990 . Median Lp(a ) levels did not differ between cases and controls and mean apo(a ) size did not vary between cases and controls in the entire study population . When adjusted for age and Lp(a ) concentration , logistic regression analysis indicated that small apo(a ) isoforms were associated with CHD deaths among smokers ( OR 3.31 ; 95 % CI 1.07 - 10.28 ) BACKGROUND Epidemiologic studies have shown that C-reactive protein ( CRP ) is a risk factor for coronary heart disease . Whether routine measurement of CRP has a role in the prediction of future coronary disease in everyday clinical practice has not yet been investigated . METHODS Within the Rotterdam Study , a population -based cohort study of 7983 men and women 55 years and older , we conducted a nested case-control study to investigate the value of CRP in coronary disease prediction . Data are based on 157 participants who experienced a myocardial infa rct ion during follow-up and 500 r and omly selected controls . High-sensitivity CRP and traditional cardiovascular risk factors were measured at baseline . RESULTS The age- and sex-adjusted relative risk of myocardial infa rct ion for subjects in the highest quartile of the population distribution of CRP compared with the lowest quartile was 2.0 ( 95 % confidence interval , 1.1 - 3.4 ) . After additional adjustment for traditional cardiovascular risk factors , the increase in risk largely disappeared ( odds ratio , 1.2 ; 95 % confidence interval , 0.6 - 2.2 ) . Adding CRP to a coronary disease risk function based on risk factors that are routinely assessed in clinical practice or to the Framingham risk function did not improve the area under the receiver operating characteristic curve of these risk functions . Sensitivity and specificity of both risk functions , computed after dichotomizing the estimated disease probabilities using prespecified cutoff points , hardly improved when CRP was added . CONCLUSION Measurement of CRP in elderly people has no additional value in coronary disease risk prediction when traditional cardiovascular risk factors are known BACKGROUND We examined the relationship between granulocyte , lymphocyte and monocyte counts and risk of coronary heart disease ( CHD ) and cardiovascular disease ( CVD ) in men and women . There is paucity of data on the differential leucocyte count and its relationship with the risk of CHD and CVD . METHODS This prospect i ve study comprised 7073 men and 9035 women who were 45 - 79 years of age and were residents of Norfolk . United Kingdom . RESULTS During an average of 8 years of follow-up we identified 857 incident CHD events and 2581 CVD incident events . Increased total leucocyte count was associated with increased risk for both CHD and CVD . The highest quartile of granulocyte count was associated with increased risk when compared to lowest quartile for CHD ( men HR 1.70 95 % CI : 1.30 - 2.21 ; women HR 1.24 95 % CI : 0.91 - 1.69 ) and for CVD ( men HR 1.46 95 % CI : 1.24 - 1.71 ; women HR 1.20 95 % CI : 1.02 - 1.42 ) . The association remained unchanged when the analyses were restricted to nonsmokers and when risk was assessed for every 1000 cells L(-1 ) increase in cell count . In multivariable models , despite adjusting for C-reactive protein ( CRP ) , the granulocyte count remained an independent predictor of CHD and CVD risk , especially amongst men . Lymphocyte or monocyte counts were not significantly associated with increased risk . In all analyses , additionally adjusting for CRP did not affect the results material ly . CONCLUSIONS In conclusion , we found that the higher risk for CHD and CVD associated with increased total leucocyte count seems to be accounted for by the increased granulocyte count The relation of serum total homocysteine and lipoprotein(a ) ( Lp(a ) ) with the incidence of atherosclerotic disease was investigated among 7424 men and women aged 40 - 64 years free of atherosclerotic disease at baseline in 1977 . During the 9-year follow-up , 134 male and 131 female cases with either myocardial infa rct ion or stroke were identified . For each case a control subject was selected belonging to the same sex and 5-year age group . Serum sample s collected in 1977 were stored at -20 degrees C and analyzed in 1991 . The mean serum homocysteine concentration of male cases and controls was 9.99 mumol/l and 9.82 mumol/l at baseline and that of female cases and controls 9.58 mumol/l and 9.24 mumol/l , respectively . The median serum Lp(a ) concentration of male cases and controls was 73 mg/l and 108 mg/l and that of female cases and controls 113 mg/l and 91 mg/l , respectively . The differences between cases and controls were not statistically significant . There was also no significant association between either homocysteine or Lp(a ) and atherosclerotic disease , myocardial infa rct ion or stroke in logistic regression analyses . The odds ratios varied from 1.00 to 1.26 for homocysteine and from 0.81 to 1.06 for Lp(a ) . The results of this prospect i ve population -based study do not support the hypotheses that serum homocysteine or Lp(a ) are risk factors for atherosclerotic disease . The lack of association between serum homocysteine and atherosclerotic disease may be due to the exceptionally low gene frequency predisposing to homocysteinemia in Finl and In 1998 , the American Heart Association convened Prevention Conference V to examine strategies for the identification of high-risk patients who need primary prevention . Among the strategies discussed was the measurement of markers of inflammation.1 The Conference concluded that “ many of these markers ( including inflammatory markers ) are not yet considered applicable for routine risk assessment because of : ( 1 ) lack of measurement st and ardization , ( 2 ) lack of consistency in epidemiological findings from prospect i ve studies with endpoints , and ( 3 ) lack of evidence that the novel marker adds to risk prediction over and above that already achievable through the use of established risk factors . ” The National Cholesterol Education Program Adult Treatment Panel III Guidelines identified these markers as emerging risk factors,1a which could be used as an optional risk factor measurement to adjust estimates of absolute risk obtained using st and ard risk factors . Since these publications , a large number of peer- review ed scientific reports have been published relating inflammatory markers to cardiovascular disease ( CVD ) . Several commercial assays for inflammatory markers have become available . As a consequence of the exp and ing research base and availability of assays , the number of inflammatory marker tests ordered by clinicians for CVD risk prediction has grown rapidly . Despite this , there has been no consensus from professional societies or governmental agencies as to how these assays of markers \n Output:\n " }, { "from": "agent", "value": "This sequential approach provides a direct measure of the number or proportion of intermediate-risk persons who could be reclassified by the new test .\nThis type of analysis provides the best information about the clinical effect of using the new test to further stratify intermediate-risk patients ." } ]