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[ "we investigated the method of switching epo to cera that does not cause a decrease in the hb level .", "fifty epo-treated patients were randomly divided into two groups in which cera was administered every two weeks ( q@w ) or every four weeks ( q@w ) .", "after @ weeks of treatment , the frequency of administration was changed to q@w in the former .", "follow-up was performed for @ weeks .", "there was no difference in the hb level between the two groups until @ weeks .", "in the q@w group , the hb maintained a stable level throughout a study period .", "however , in the q@w group , the hb level was significantly lower than in the q@w group at weeks @ , @ , and @ .", "epo switching to cera without a decrease in the hb level could be achieved by administering cera every two weeks , but not every four weeks , for a specific period after switching ." ]
we investigated the method of switching epo to cera that does not cause a decrease in the hb level . fifty epo-treated patients were randomly divided into two groups in which cera was administered every two weeks ( q@w ) or every four weeks ( q@w ) . after @ weeks of treatment , the frequency of administration was changed to q@w in the former . follow-up was performed for @ weeks . there was no difference in the hb level between the two groups until @ weeks . in the q@w group , the hb maintained a stable level throughout a study period . however , in the q@w group , the hb level was significantly lower than in the q@w group at weeks @ , @ , and @ . epo switching to cera without a decrease in the hb level could be achieved by administering cera every two weeks , but not every four weeks , for a specific period after switching .
25,502,179
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "cardiovascular disease ( cvd ) and the underlying atherosclerosis begin in childhood , and their presence and intensity are related to known cardiovascular disease risk factors .", "attention to risk factor control in childhood has the potential to reduce subsequent risk of cvd .", "the young hearts strong starts study was designed to test strategies facilitating adoption of the national , heart , lung and blood institute supported integrated guidelines for cardiovascular health and risk reduction in children and adolescents .", "this study compares guideline-based quality measures for body mass index , blood pressure , and tobacco using two strategies : a multifaceted , practice-directed intervention versus standard dissemination .", "two primary care research networks recruited practices and provided support for the intervention and outcome evaluations .", "individual practices were randomly assigned to the intervention or control groups using a cluster randomized design based on network affiliation , number of clinicians per practice , urban versus nonurban location , and practice type .", "the units of observation are individual children because measure adherence is abstracted from individual patient 's medical records .", "the units of randomization are physician practices .", "this results in a multilevel design in which patients are nested within practices .", "the intervention practices received toolkits and supported guideline implementation including academic detailing , an ongoing e-learning group .", "this project is aligned with the american board of pediatrics maintenance of certification requirements including monthly physician self-abstraction , webinars , and other elements of the trial .", "this trial will provide an opportunity to demonstrate tools and strategies to enhance cv prevention in children by guideline-based interventions ." ]
cardiovascular disease ( cvd ) and the underlying atherosclerosis begin in childhood , and their presence and intensity are related to known cardiovascular disease risk factors . attention to risk factor control in childhood has the potential to reduce subsequent risk of cvd . the young hearts strong starts study was designed to test strategies facilitating adoption of the national , heart , lung and blood institute supported integrated guidelines for cardiovascular health and risk reduction in children and adolescents . this study compares guideline-based quality measures for body mass index , blood pressure , and tobacco using two strategies : a multifaceted , practice-directed intervention versus standard dissemination . two primary care research networks recruited practices and provided support for the intervention and outcome evaluations . individual practices were randomly assigned to the intervention or control groups using a cluster randomized design based on network affiliation , number of clinicians per practice , urban versus nonurban location , and practice type . the units of observation are individual children because measure adherence is abstracted from individual patient 's medical records . the units of randomization are physician practices . this results in a multilevel design in which patients are nested within practices . the intervention practices received toolkits and supported guideline implementation including academic detailing , an ongoing e-learning group . this project is aligned with the american board of pediatrics maintenance of certification requirements including monthly physician self-abstraction , webinars , and other elements of the trial . this trial will provide an opportunity to demonstrate tools and strategies to enhance cv prevention in children by guideline-based interventions .
24,295,879
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS" ]
[ "checklists may help reduce discharge errors ; however , current paper checklists have limited functionality .", "in @ a best-practice discharge checklist using the electronic health record ( ehr ) was developed and evaluated at stanford university medical center ( stanford , california ) in a cluster randomized trial to evaluate its usage , user satisfaction , and impact on physicians ' work flow .", "the study was divided into four phases .", "in phase i , on the survey ( n = @ ) , most of the participants ( @ % ) reported using memory to remember discharge tasks .", "on a @-@ scale , perception of checklists as being useful was strong ( mean , @ ; standard deviation -lsb- sd -rsb- , @ ) , as was interest in ehr checklists ( @ , @ ) .", "in phase ii , the checklist consisted of @ tasks categorized by admission , hospitalization , and discharge-planning .", "in phase iii , the checklist was implemented as an ehr `` smart-phrase '' allowing for automatic insertion .", "in phase iv , in a trial with @ participating physicians , @ ehr checklist users reported higher usage than @ paper users ( @ versus @ , p = @ ) , as well as higher checklist integration with work flow ( @ versus @ , p = @ ) , usefulness of checklist ( @ versus .", "@ , p = @ ) , discharge confidence ( @ versus @ , p = @ ) , and discharge efficiency ( @ versus @ , p = @ ) .", "increasing ehr checklist use was correlated with usefulness ( r = @ , p < @ ) , confidence ( r = @ , p < @ ) , and efficiency ( r = @ , p < @ ) .", "the ehr checklist reminded physicians to complete discharge tasks , improved confidence , and increased process efficiency .", "this is the first study to show that medicine residents use `` memory '' as the most common method for remembering discharge tasks .", "these data reinforce the need for a formalized tool , such as a checklist , that residents can rely on to complete important discharge tasks ." ]
checklists may help reduce discharge errors ; however , current paper checklists have limited functionality . in @ a best-practice discharge checklist using the electronic health record ( ehr ) was developed and evaluated at stanford university medical center ( stanford , california ) in a cluster randomized trial to evaluate its usage , user satisfaction , and impact on physicians ' work flow . the study was divided into four phases . in phase i , on the survey ( n = @ ) , most of the participants ( @ % ) reported using memory to remember discharge tasks . on a @-@ scale , perception of checklists as being useful was strong ( mean , @ ; standard deviation -lsb- sd -rsb- , @ ) , as was interest in ehr checklists ( @ , @ ) . in phase ii , the checklist consisted of @ tasks categorized by admission , hospitalization , and discharge-planning . in phase iii , the checklist was implemented as an ehr `` smart-phrase '' allowing for automatic insertion . in phase iv , in a trial with @ participating physicians , @ ehr checklist users reported higher usage than @ paper users ( @ versus @ , p = @ ) , as well as higher checklist integration with work flow ( @ versus @ , p = @ ) , usefulness of checklist ( @ versus . @ , p = @ ) , discharge confidence ( @ versus @ , p = @ ) , and discharge efficiency ( @ versus @ , p = @ ) . increasing ehr checklist use was correlated with usefulness ( r = @ , p < @ ) , confidence ( r = @ , p < @ ) , and efficiency ( r = @ , p < @ ) . the ehr checklist reminded physicians to complete discharge tasks , improved confidence , and increased process efficiency . this is the first study to show that medicine residents use `` memory '' as the most common method for remembering discharge tasks . these data reinforce the need for a formalized tool , such as a checklist , that residents can rely on to complete important discharge tasks .
25,977,128
[ "BACKGROUND", "BACKGROUND", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "coordination of the tasks of performing chest compressions and defibrillation can lead to communication challenges that may prolong time spent off the chest .", "the purpose of this study was to determine whether defibrillation provided by the provider performing chest compressions led to a decrease in peri-shock pauses as compared to defibrillation administered by a second provider , in a simulated cardiac arrest scenario .", "this was a randomized , controlled study measuring pauses in chest compressions for defibrillation in a simulated cardiac arrest model .", "we approached hospital providers with current cpr certification for participation between july , @ and october , @ .", "volunteers were randomized to control ( facilitator-administered defibrillation ) or experimental ( compressor-administered defibrillation ) groups .", "all participants completed one minute of chest compressions on a mannequin in a shockable rhythm prior to administration of defibrillation .", "we measured and compared pauses for defibrillation in both groups .", "out of @ total participants , we analyzed data from @ defibrillations .", "compressor-initiated defibrillation resulted in a significantly lower pre-shock hands-off time ( @ s ; @ % ci : @-@ @ ) compared to facilitator-initiated defibrillation ( @ s ; @ % ci : @-@ @ ) .", "furthermore , compressor-initiated defibrillation resulted in a significantly lower peri-shock hands-off time ( @ s ; @ % ci : @-@ @ ) compared to facilitator-initiated defibrillation ( @ s ; @ % ci : @-@ @ ) .", "assigning the responsibility for shock delivery to the provider performing compressions encourages continuous compressions throughout the charging period and decreases total time spent off the chest .", "however , as this was a simulation-based study , clinical implementation is necessary to further evaluate these potential benefits ." ]
coordination of the tasks of performing chest compressions and defibrillation can lead to communication challenges that may prolong time spent off the chest . the purpose of this study was to determine whether defibrillation provided by the provider performing chest compressions led to a decrease in peri-shock pauses as compared to defibrillation administered by a second provider , in a simulated cardiac arrest scenario . this was a randomized , controlled study measuring pauses in chest compressions for defibrillation in a simulated cardiac arrest model . we approached hospital providers with current cpr certification for participation between july , @ and october , @ . volunteers were randomized to control ( facilitator-administered defibrillation ) or experimental ( compressor-administered defibrillation ) groups . all participants completed one minute of chest compressions on a mannequin in a shockable rhythm prior to administration of defibrillation . we measured and compared pauses for defibrillation in both groups . out of @ total participants , we analyzed data from @ defibrillations . compressor-initiated defibrillation resulted in a significantly lower pre-shock hands-off time ( @ s ; @ % ci : @-@ @ ) compared to facilitator-initiated defibrillation ( @ s ; @ % ci : @-@ @ ) . furthermore , compressor-initiated defibrillation resulted in a significantly lower peri-shock hands-off time ( @ s ; @ % ci : @-@ @ ) compared to facilitator-initiated defibrillation ( @ s ; @ % ci : @-@ @ ) . assigning the responsibility for shock delivery to the provider performing compressions encourages continuous compressions throughout the charging period and decreases total time spent off the chest . however , as this was a simulation-based study , clinical implementation is necessary to further evaluate these potential benefits .
24,672,620
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the successful treatment of intraabdominal infection requires a combination of anatomical source control and antibiotics .", "the appropriate duration of antimicrobial therapy remains unclear .", "we randomly assigned @ patients with complicated intraabdominal infection and adequate source control to receive antibiotics until @ days after the resolution of fever , leukocytosis , and ileus , with a maximum of @ days of therapy ( control group ) , or to receive a fixed course of antibiotics ( experimental group ) for @ calendar days .", "the primary outcome was a composite of surgical-site infection , recurrent intraabdominal infection , or death within @ days after the index source-control procedure , according to treatment group .", "secondary outcomes included the duration of therapy and rates of subsequent infections .", "surgical-site infection , recurrent intraabdominal infection , or death occurred in @ of @ patients in the experimental group ( @ % ) , as compared with @ of @ patients in the control group ( @ % ) ( absolute difference , -@ percentage point ; @ % confidence interval -lsb- ci -rsb- , -@ to @ ; p = @ ) .", "the median duration of antibiotic therapy was @ days ( interquartile range , @ to @ ) in the experimental group , as compared with @ days ( interquartile range , @ to @ ) in the control group ( absolute difference , -@ days ; @ % ci , -@ to -@ ; p < @ ) .", "no significant between-group differences were found in the individual rates of the components of the primary outcome or in other secondary outcomes .", "in patients with intraabdominal infections who had undergone an adequate source-control procedure , the outcomes after fixed-duration antibiotic therapy ( approximately @ days ) were similar to those after a longer course of antibiotics ( approximately @ days ) that extended until after the resolution of physiological abnormalities .", "( funded by the national institutes of health ; stop-it clinicaltrials.gov number , nct@ . )" ]
the successful treatment of intraabdominal infection requires a combination of anatomical source control and antibiotics . the appropriate duration of antimicrobial therapy remains unclear . we randomly assigned @ patients with complicated intraabdominal infection and adequate source control to receive antibiotics until @ days after the resolution of fever , leukocytosis , and ileus , with a maximum of @ days of therapy ( control group ) , or to receive a fixed course of antibiotics ( experimental group ) for @ calendar days . the primary outcome was a composite of surgical-site infection , recurrent intraabdominal infection , or death within @ days after the index source-control procedure , according to treatment group . secondary outcomes included the duration of therapy and rates of subsequent infections . surgical-site infection , recurrent intraabdominal infection , or death occurred in @ of @ patients in the experimental group ( @ % ) , as compared with @ of @ patients in the control group ( @ % ) ( absolute difference , -@ percentage point ; @ % confidence interval -lsb- ci -rsb- , -@ to @ ; p = @ ) . the median duration of antibiotic therapy was @ days ( interquartile range , @ to @ ) in the experimental group , as compared with @ days ( interquartile range , @ to @ ) in the control group ( absolute difference , -@ days ; @ % ci , -@ to -@ ; p < @ ) . no significant between-group differences were found in the individual rates of the components of the primary outcome or in other secondary outcomes . in patients with intraabdominal infections who had undergone an adequate source-control procedure , the outcomes after fixed-duration antibiotic therapy ( approximately @ days ) were similar to those after a longer course of antibiotics ( approximately @ days ) that extended until after the resolution of physiological abnormalities . ( funded by the national institutes of health ; stop-it clinicaltrials.gov number , nct@ . )
25,992,746
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the genetic polymorphism concerning the @-subunit of platelet integrin receptor glycoprotein iiia is held responsible for enhanced binding of adhesive proteins resulting in increased thrombogenic potential .", "whether it is associated with mortality , hba@c or platelet volume is tested prospectively in an epidemiological cohort .", "population-based cooperative health research in the region of augsburg ( kora ) s@-survey ( n = @,@ ) was investigated for prognostic value of pla@a@-polymorphism regarding all-cause mortality , correlation with hba@c , and mean platelet volume .", "multivariate analysis was performed to investigate association between genotype and key variables .", "prevalence of thrombogenic allele variant pla@ was @ % .", "multivariate analysis revealed no association between pla@a@ polymorphism and mortality in the kora-cohort .", "hba@c was a prognostic marker of mortality in non-diabetic persons resulting in j-shaped risk curve with dip at hba@c = @ % ( @ mmol/mol ) , confirming previous findings regarding aged kora-s@ participants ( @-@ years ) .", "pla@a@ was significantly associated with elevated hba@c levels in diabetic patients ( n = @ ) and reduced mean platelet volume in general population .", "in non-diabetic participants ( n = @,@ ) , carriers of pla@ allele variant presenting with hba@c > @ % ( @ mmol/mol ) showed higher relative risk of mortality with increasing hba@c .", "pla@a@ polymorphism is associated with mortality in participants with hba@c ranging from @ % ( @ mmol/mol ) to @ % ( @ mmol/mol ) .", "maintenance of euglycemic control and antiplatelet therapy are therefore regarded as effective primary prevention in this group ." ]
the genetic polymorphism concerning the @-subunit of platelet integrin receptor glycoprotein iiia is held responsible for enhanced binding of adhesive proteins resulting in increased thrombogenic potential . whether it is associated with mortality , hba@c or platelet volume is tested prospectively in an epidemiological cohort . population-based cooperative health research in the region of augsburg ( kora ) s@-survey ( n = @,@ ) was investigated for prognostic value of pla@a@-polymorphism regarding all-cause mortality , correlation with hba@c , and mean platelet volume . multivariate analysis was performed to investigate association between genotype and key variables . prevalence of thrombogenic allele variant pla@ was @ % . multivariate analysis revealed no association between pla@a@ polymorphism and mortality in the kora-cohort . hba@c was a prognostic marker of mortality in non-diabetic persons resulting in j-shaped risk curve with dip at hba@c = @ % ( @ mmol/mol ) , confirming previous findings regarding aged kora-s@ participants ( @-@ years ) . pla@a@ was significantly associated with elevated hba@c levels in diabetic patients ( n = @ ) and reduced mean platelet volume in general population . in non-diabetic participants ( n = @,@ ) , carriers of pla@ allele variant presenting with hba@c > @ % ( @ mmol/mol ) showed higher relative risk of mortality with increasing hba@c . pla@a@ polymorphism is associated with mortality in participants with hba@c ranging from @ % ( @ mmol/mol ) to @ % ( @ mmol/mol ) . maintenance of euglycemic control and antiplatelet therapy are therefore regarded as effective primary prevention in this group .
24,886,443
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the large placebo effect observed in prior acupuncture trials presents a substantial challenge for interpretation of the efficacy of acupuncture .", "we sought to evaluate the relationship between response expectancy , a key component of the placebo effect over time , and treatment outcome in real and sham electroacupuncture ( ea ) .", "we analyzed data from a randomized controlled trial of ea and sham acupuncture ( sa ) for joint pain attributable to aromatase inhibitors among women with breast cancer .", "responders were identified using the patient global impression of change instrument at week @ ( end of intervention ) .", "the acupuncture expectancy scale ( aes ) was used to measure expectancy four times during the trial .", "linear mixed-effects models were used to evaluate the association between expectancy and treatment response .", "in the wait list control group , aes remained unchanged over treatment .", "in the sa group , baseline aes was significantly higher in responders than nonresponders ( @ vs @ , p = @ ) and aes did not change over time .", "in the ea group , baseline aes scores did not differ between responders and nonresponders ( @ vs @ , p = @ ) ; however , aes increased in responders compared with nonresponders over time ( p = @ for responder and time interaction term ) with significant difference at the end of trial for responders versus nonresponders ( @ vs @ , p = @ ) .", "baseline higher response expectancy predicts treatment response in sa , but not in ea .", "divergent mechanisms may exist for how sa and ea influence pain outcomes , and patients with low expectancy may do better with ea than sa ." ]
the large placebo effect observed in prior acupuncture trials presents a substantial challenge for interpretation of the efficacy of acupuncture . we sought to evaluate the relationship between response expectancy , a key component of the placebo effect over time , and treatment outcome in real and sham electroacupuncture ( ea ) . we analyzed data from a randomized controlled trial of ea and sham acupuncture ( sa ) for joint pain attributable to aromatase inhibitors among women with breast cancer . responders were identified using the patient global impression of change instrument at week @ ( end of intervention ) . the acupuncture expectancy scale ( aes ) was used to measure expectancy four times during the trial . linear mixed-effects models were used to evaluate the association between expectancy and treatment response . in the wait list control group , aes remained unchanged over treatment . in the sa group , baseline aes was significantly higher in responders than nonresponders ( @ vs @ , p = @ ) and aes did not change over time . in the ea group , baseline aes scores did not differ between responders and nonresponders ( @ vs @ , p = @ ) ; however , aes increased in responders compared with nonresponders over time ( p = @ for responder and time interaction term ) with significant difference at the end of trial for responders versus nonresponders ( @ vs @ , p = @ ) . baseline higher response expectancy predicts treatment response in sa , but not in ea . divergent mechanisms may exist for how sa and ea influence pain outcomes , and patients with low expectancy may do better with ea than sa .
25,749,596
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "we aimed to evaluate the effects of raw red onion consumption on metabolic features in overweight and obese women with polycystic ovary syndrome .", "in this randomized controlled clinical trial , the patients ( n = @ ) were randomly allocated to the intervention group as ` high-onion ' ( raw red onions : @ @-@ g/day if overweight and @ @-@ g/day if obese ) or to the control group as ` low-onion ' ( raw red onions : @ @-@ g/day ) along with limited liliaceous vegetables for @ weeks .", "body mass index , dietary record , and metabolic parameters ( fasting blood sugar , triglycerides , total cholesterol , low-density lipoprotein cholesterol , high-density lipoprotein cholesterol , and lipoprotein ( a ) ) were evaluated in the follicular phase of the menstrual cycle at baseline and after @ weeks .", "hormonal variables ( progesterone , prolactin , and @-oh progesterone ) were also measured at baseline .", "onion significantly decreased the levels of total cholesterol within each group ; however , these changes were stronger in the high-onion group ( weighted mean differences -lsb- wmd -rsb- : -@ -lsb- @ % confidence interval -lsb- ci -rsb- : -@ , -@ -rsb- ; p = @ ) than in the low-onion group ( wmd : -@ -lsb- @ % ci : -@ , -@ -rsb- ; p = @ ) .", "similarly , low-density lipoprotein cholesterol decreased significantly ( wmd : -@ -lsb- @ % ci : -@ , -@ ) ; p = @ ) in the high-onion group , and ( wmd : -@ -lsb- @ % ci -@ , -@ -rsb- ; p = @ ) in the low-onion group after treatment .", "the levels of fasting blood sugar , triglycerides , high-density lipoprotein cholesterol and lipoprotein ( a ) did not differ significantly after @-week onion treatment .", "adjustment for confounders did not make any significant changes in any of the parameters in post-treatment levels .", "raw red onion consumption appears to be effective as a cholesterol-lowering food agent in women with polycystic ovary syndrome .", "however , further investigation is warranted ." ]
we aimed to evaluate the effects of raw red onion consumption on metabolic features in overweight and obese women with polycystic ovary syndrome . in this randomized controlled clinical trial , the patients ( n = @ ) were randomly allocated to the intervention group as ` high-onion ' ( raw red onions : @ @-@ g/day if overweight and @ @-@ g/day if obese ) or to the control group as ` low-onion ' ( raw red onions : @ @-@ g/day ) along with limited liliaceous vegetables for @ weeks . body mass index , dietary record , and metabolic parameters ( fasting blood sugar , triglycerides , total cholesterol , low-density lipoprotein cholesterol , high-density lipoprotein cholesterol , and lipoprotein ( a ) ) were evaluated in the follicular phase of the menstrual cycle at baseline and after @ weeks . hormonal variables ( progesterone , prolactin , and @-oh progesterone ) were also measured at baseline . onion significantly decreased the levels of total cholesterol within each group ; however , these changes were stronger in the high-onion group ( weighted mean differences -lsb- wmd -rsb- : -@ -lsb- @ % confidence interval -lsb- ci -rsb- : -@ , -@ -rsb- ; p = @ ) than in the low-onion group ( wmd : -@ -lsb- @ % ci : -@ , -@ -rsb- ; p = @ ) . similarly , low-density lipoprotein cholesterol decreased significantly ( wmd : -@ -lsb- @ % ci : -@ , -@ ) ; p = @ ) in the high-onion group , and ( wmd : -@ -lsb- @ % ci -@ , -@ -rsb- ; p = @ ) in the low-onion group after treatment . the levels of fasting blood sugar , triglycerides , high-density lipoprotein cholesterol and lipoprotein ( a ) did not differ significantly after @-week onion treatment . adjustment for confounders did not make any significant changes in any of the parameters in post-treatment levels . raw red onion consumption appears to be effective as a cholesterol-lowering food agent in women with polycystic ovary syndrome . however , further investigation is warranted .
24,612,081
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "elderly patients are at high risk for both ischemic and bleeding events .", "platelet monitoring offers the opportunity to individualized antiplatelet therapy to optimize the therapeutic risk/benefit ratio .", "the antarctic study is designed to demonstrate the superiority of a strategy of platelet function monitoring with dose and drug adjustment in patients initially on prasugrel @ mg as compared with a more conventional strategy using prasugrel @ mg without monitoring and without adjustment ( conventional treatment arm ) to reduce the primary end point evaluated @ year after stent percutaneous coronary intervention in elderly patients presenting with an acute coronary syndrome ( acs ) .", "antarctic is a multicenter , prospective , open-label study with @ parallel arms .", "a total of @ elderly patients ( @ years ) undergoing stent percutaneous coronary intervention for acs are to be enrolled .", "the primary end point is the time to first occurrence of cardiovascular death , myocardial infarction , stroke , definite stent thrombosis , urgent revascularization , and bleeding complications ( bleeding academic research consortium definition @ , @ , or @ ) .", "platelet function analyses will be performed @ days after randomization and repeated @ days later in patients who require a change in treatment .", "antarctic is a nationwide , prospective , open-label study testing a strategy of platelet function monitoring with dose and drug adjustment to reduce ischemic and bleeding complications in elderly acs patients undergoing coronary stenting ." ]
elderly patients are at high risk for both ischemic and bleeding events . platelet monitoring offers the opportunity to individualized antiplatelet therapy to optimize the therapeutic risk/benefit ratio . the antarctic study is designed to demonstrate the superiority of a strategy of platelet function monitoring with dose and drug adjustment in patients initially on prasugrel @ mg as compared with a more conventional strategy using prasugrel @ mg without monitoring and without adjustment ( conventional treatment arm ) to reduce the primary end point evaluated @ year after stent percutaneous coronary intervention in elderly patients presenting with an acute coronary syndrome ( acs ) . antarctic is a multicenter , prospective , open-label study with @ parallel arms . a total of @ elderly patients ( @ years ) undergoing stent percutaneous coronary intervention for acs are to be enrolled . the primary end point is the time to first occurrence of cardiovascular death , myocardial infarction , stroke , definite stent thrombosis , urgent revascularization , and bleeding complications ( bleeding academic research consortium definition @ , @ , or @ ) . platelet function analyses will be performed @ days after randomization and repeated @ days later in patients who require a change in treatment . antarctic is a nationwide , prospective , open-label study testing a strategy of platelet function monitoring with dose and drug adjustment to reduce ischemic and bleeding complications in elderly acs patients undergoing coronary stenting .
25,440,795
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS" ]
[ "vaniprevir ( mk-@ ) is a hepatitis c virus ( hcv ) non-structural @/@a protease inhibitor which significantly increases virologic response rates in hcv genotype ( gt ) @-infected patients when added to peginterferon and ribavirin ( pr ) .", "this was a phase ii , multicenter , double-blind , randomized , dose-ranging study in japanese patients with hcv gt@ infection and previous relapse .", "patients received twice daily vaniprevir @ , @ , or @ mg , or placebo plus pr for @ weeks then pr alone for @ weeks .", "further treatment with pr was continued up to a maximum of @ weeks .", "the primary endpoint was rapid virologic response ( rvr ; undetectable hcv rna at treatment week @ ) .", "ninety patients completed @ weeks of vaniprevir/placebo plus pr .", "rates of rvr were significantly higher with vaniprevir compared with placebo ( @ , @ , and @ % in the vaniprevir @ - , @ - , and @-mg arms versus @ % with control ; p < @ for all comparisons ) .", "rates of svr , an exploratory analysis , in the vaniprevir @ - , @ - , @-mg , and control arms were @ , @ , @ , and @ % , respectively .", "no patient had virologic breakthrough or non-response while receiving vaniprevir .", "there were no serious adverse events ( aes ) or discontinuations due to an ae during vaniprevir treatment .", "diarrhea and nausea were more common with vaniprevir @ mg than control or lower vaniprevir doses .", "the addition of vaniprevir to pr was associated with an increase in rvr and svr .", "combined with a generally safe and well-tolerated profile , these data supported the further evaluation of vaniprevir in japanese patients with hcv gt@ infection ( #nct @ ) ." ]
vaniprevir ( mk-@ ) is a hepatitis c virus ( hcv ) non-structural @/@a protease inhibitor which significantly increases virologic response rates in hcv genotype ( gt ) @-infected patients when added to peginterferon and ribavirin ( pr ) . this was a phase ii , multicenter , double-blind , randomized , dose-ranging study in japanese patients with hcv gt@ infection and previous relapse . patients received twice daily vaniprevir @ , @ , or @ mg , or placebo plus pr for @ weeks then pr alone for @ weeks . further treatment with pr was continued up to a maximum of @ weeks . the primary endpoint was rapid virologic response ( rvr ; undetectable hcv rna at treatment week @ ) . ninety patients completed @ weeks of vaniprevir/placebo plus pr . rates of rvr were significantly higher with vaniprevir compared with placebo ( @ , @ , and @ % in the vaniprevir @ - , @ - , and @-mg arms versus @ % with control ; p < @ for all comparisons ) . rates of svr , an exploratory analysis , in the vaniprevir @ - , @ - , @-mg , and control arms were @ , @ , @ , and @ % , respectively . no patient had virologic breakthrough or non-response while receiving vaniprevir . there were no serious adverse events ( aes ) or discontinuations due to an ae during vaniprevir treatment . diarrhea and nausea were more common with vaniprevir @ mg than control or lower vaniprevir doses . the addition of vaniprevir to pr was associated with an increase in rvr and svr . combined with a generally safe and well-tolerated profile , these data supported the further evaluation of vaniprevir in japanese patients with hcv gt@ infection ( #nct @ ) .
25,115,901
[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the aim of this study was to gain further understanding of placebo response in binge eating disorder .", "we pooled participant-level data from @ double-blind , placebo-controlled , randomized trials of medications for binge eating disorder .", "the primary outcomes were response ( @ % reduction in binge eating episodes ) , cessation of binge eating episodes , change in mean weekly binge eating episodes and binge eating episodes per week .", "of @ participants receiving placebo , @ ( @ % ) were responders and @ ( @ % ) attained cessation .", "placebo-treated participants significantly reduced their binge eating .", "the mean ( sd ) binge eating episodes per week at baseline was @ ( @ ) and at endpoint was @ ( @ ) .", "lower baseline binge eating episode frequency and longer study participation were significantly associated with response and cessation .", "less severe eating pathology at baseline was associated with higher placebo response and cessation rates .", "future clinical trials may want to stipulate that participants exceed a threshold of illness severity , which may lead to better placebo and drug separation ." ]
the aim of this study was to gain further understanding of placebo response in binge eating disorder . we pooled participant-level data from @ double-blind , placebo-controlled , randomized trials of medications for binge eating disorder . the primary outcomes were response ( @ % reduction in binge eating episodes ) , cessation of binge eating episodes , change in mean weekly binge eating episodes and binge eating episodes per week . of @ participants receiving placebo , @ ( @ % ) were responders and @ ( @ % ) attained cessation . placebo-treated participants significantly reduced their binge eating . the mean ( sd ) binge eating episodes per week at baseline was @ ( @ ) and at endpoint was @ ( @ ) . lower baseline binge eating episode frequency and longer study participation were significantly associated with response and cessation . less severe eating pathology at baseline was associated with higher placebo response and cessation rates . future clinical trials may want to stipulate that participants exceed a threshold of illness severity , which may lead to better placebo and drug separation .
24,399,652
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "although bipap has been used as an adjunct to exercise , little is know about its effect on exercise in copd .", "we aimed to evaluate the acute effect of bipap delivered with a standard valve ( vision , respironics ) , compared to no assist , on exercise capacity in individuals with copd .", "peak exercise workload ( wlpeak ) , dyspnea ( borg ) , end-expiratory lung volume ( eelv ) , tidal volume ( vt ) , minute ventilation ( ve ) , o@ uptake ( vo@ ) , and co@ production ( vco@ ) were assessed in @ copd patients ( fev@ @ @ % pred ) during three symptom-limited bicycle exercise tests while breathing i ) without a ventilator ( nops ) , ii ) with a pressure support ( ps ) of @ cm h@o ( ps@ ; ipap & epap @ cm h@o ) and iii ) ps of @ cm h@o ( ps@ ; ipap @ & epap @ cm h@o ) on separate days using a randomized crossover design .", "wlpeak was significantly lower with ps@ ( @ @ ) and ps@ ( @ @ ) than nops ( @ @ ) ( p < @ ) .", "dyspnea at peak exercise was similar with nops , ps@ and ps@ ; at isoload it was lower with nops compared to ps@ and ps@ ( p < @ ) .", "vt and ve were highest with ps@ and lowest with nops both at peak exercise and isoload ( p < @ ) .", "eelv was similar at peak exercise with all three conditions .", "vo@ and vco@ were greater with ps@ and ps@ than nops ( p < @ ) , both at peak exercise and isoload .", "use of bipap with a standard exhalation valve during exercise increases vt and ve at the expense of augmenting vco@ and dyspnea , which in turns reduces wlpeak in copd patients ." ]
although bipap has been used as an adjunct to exercise , little is know about its effect on exercise in copd . we aimed to evaluate the acute effect of bipap delivered with a standard valve ( vision , respironics ) , compared to no assist , on exercise capacity in individuals with copd . peak exercise workload ( wlpeak ) , dyspnea ( borg ) , end-expiratory lung volume ( eelv ) , tidal volume ( vt ) , minute ventilation ( ve ) , o@ uptake ( vo@ ) , and co@ production ( vco@ ) were assessed in @ copd patients ( fev@ @ @ % pred ) during three symptom-limited bicycle exercise tests while breathing i ) without a ventilator ( nops ) , ii ) with a pressure support ( ps ) of @ cm h@o ( ps@ ; ipap & epap @ cm h@o ) and iii ) ps of @ cm h@o ( ps@ ; ipap @ & epap @ cm h@o ) on separate days using a randomized crossover design . wlpeak was significantly lower with ps@ ( @ @ ) and ps@ ( @ @ ) than nops ( @ @ ) ( p < @ ) . dyspnea at peak exercise was similar with nops , ps@ and ps@ ; at isoload it was lower with nops compared to ps@ and ps@ ( p < @ ) . vt and ve were highest with ps@ and lowest with nops both at peak exercise and isoload ( p < @ ) . eelv was similar at peak exercise with all three conditions . vo@ and vco@ were greater with ps@ and ps@ than nops ( p < @ ) , both at peak exercise and isoload . use of bipap with a standard exhalation valve during exercise increases vt and ve at the expense of augmenting vco@ and dyspnea , which in turns reduces wlpeak in copd patients .
24,946,024
[ "BACKGROUND", "BACKGROUND", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "heart rate characteristics monitoring for early detection of late-onset neonatal sepsis was first described in @ .", "this technique , which uses mathematical methods to report the fold-increase in the risk of imminent neonatal sepsis , adds independent information to laboratory tests and clinical findings , and , in a large randomized trial , reduced nicu mortality of very low birth weight infants .", "through re-analysis and new secondary analyses of published studies , we have systematically evaluated the utility of this new risk marker for screening the growing population of premature infants .", "we followed the guidelines proposed by hlatky et al. ( circulation , @:@ -@ , @ ) , reviewed past works , and re-analyzed data from @,@ patients receiving conventional monitoring alone , @ of whom had @ episodes of proven sepsis , in the large randomized trial .", "heart rate characteristics monitoring passed all phases of risk marker development from proof of concept to improvement of clinical outcomes .", "the predictiveness curve affirmed good calibration , and addition of the heart rate characteristics index to predictive models using standard risk factors favorably impacted the receiver operating characteristic curve area ( increase of @ ) , continuous net reclassification index ( @ ) and the integrated discrimination index ( @ ) , and compares well to other modern risk factors .", "heart rate characteristics monitoring is a validated risk marker for sepsis in the nicu ." ]
heart rate characteristics monitoring for early detection of late-onset neonatal sepsis was first described in @ . this technique , which uses mathematical methods to report the fold-increase in the risk of imminent neonatal sepsis , adds independent information to laboratory tests and clinical findings , and , in a large randomized trial , reduced nicu mortality of very low birth weight infants . through re-analysis and new secondary analyses of published studies , we have systematically evaluated the utility of this new risk marker for screening the growing population of premature infants . we followed the guidelines proposed by hlatky et al. ( circulation , @:@ -@ , @ ) , reviewed past works , and re-analyzed data from @,@ patients receiving conventional monitoring alone , @ of whom had @ episodes of proven sepsis , in the large randomized trial . heart rate characteristics monitoring passed all phases of risk marker development from proof of concept to improvement of clinical outcomes . the predictiveness curve affirmed good calibration , and addition of the heart rate characteristics index to predictive models using standard risk factors favorably impacted the receiver operating characteristic curve area ( increase of @ ) , continuous net reclassification index ( @ ) and the integrated discrimination index ( @ ) , and compares well to other modern risk factors . heart rate characteristics monitoring is a validated risk marker for sepsis in the nicu .
24,248,424
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "combining a long-acting muscarinic antagonist with a long-acting - agonist has been shown to be pharmacologically useful in patients with chronic obstructive pulmonary disease ( copd ) .", "the aim of the present study was to evaluate the effectiveness of the dual bronchodilator therapy on airway dimensions in copd .", "patients ( n = @ ) were randomly assigned to receive tiotropium ( @g once daily ) , indacaterol ( @g once daily ) or tiotropium plus indacaterol for @ weeks .", "quantitative computed tomography ( ct ) , pulmonary function and health status ( st. george 's respiratory questionnaire ) were measured .", "compared with tiotropium or indacaterol alone , combination therapy resulted in a significant decrease in percentage wall area ( wa % ) and wall thickness , corrected for body surface area , and an increase in luminal area ( ai/bsa ) .", "concurrent treatment was superior to monotherapy in physiological indices , including forced vital capacity , forced expiratory volume in @s ( fev ) and inspiratory capacity .", "the changes in wa % and ai/bsa were significantly correlated with changes in fev ( r = -@ , p < @ and r = @ , p < @ ) .", "there were more significant improvements in sgrq scores after treatment with combined therapy than with either treatment alone .", "concurrent therapy with tiotropium and indacaterol is effective for copd patients to promote reduction in airway wall thickness , bronchodilation , and improvements in lung function compared with a single inhaler ." ]
combining a long-acting muscarinic antagonist with a long-acting - agonist has been shown to be pharmacologically useful in patients with chronic obstructive pulmonary disease ( copd ) . the aim of the present study was to evaluate the effectiveness of the dual bronchodilator therapy on airway dimensions in copd . patients ( n = @ ) were randomly assigned to receive tiotropium ( @g once daily ) , indacaterol ( @g once daily ) or tiotropium plus indacaterol for @ weeks . quantitative computed tomography ( ct ) , pulmonary function and health status ( st. george 's respiratory questionnaire ) were measured . compared with tiotropium or indacaterol alone , combination therapy resulted in a significant decrease in percentage wall area ( wa % ) and wall thickness , corrected for body surface area , and an increase in luminal area ( ai/bsa ) . concurrent treatment was superior to monotherapy in physiological indices , including forced vital capacity , forced expiratory volume in @s ( fev ) and inspiratory capacity . the changes in wa % and ai/bsa were significantly correlated with changes in fev ( r = -@ , p < @ and r = @ , p < @ ) . there were more significant improvements in sgrq scores after treatment with combined therapy than with either treatment alone . concurrent therapy with tiotropium and indacaterol is effective for copd patients to promote reduction in airway wall thickness , bronchodilation , and improvements in lung function compared with a single inhaler .
24,708,031
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to determine the subjective and objective outcomes of retroperitoneoscopic vs open pyeloplasty with minimal incision in a prospective randomized comparison study .", "in this study between august @ to july @ , @ patients underwent retroperitoneal laparoscopic pyeloplasty and @ open pyeloplasty with minimal incision ( incision length < @ cm ) after randomization .", "the @ groups were compared for the visual pain score on the first and second postoperative days as the primary end point of the study .", "complications were recorded and graded using dindo-modified clavien classification of surgical complications .", "success rates were evaluated by improvement in pain score and objectively by diethylene triamine penta-acetic acid renal scan and other parameters .", "statistical analysis was performed with spss version @ ( ibm ) with p < @ considered statistically significant .", "the difference in the visual pain score ( @ vs @ on day @ ; @ vs @ on day @ ) and the diclofenac requirements ( @ vs @ mg ) were statistically significant and more in the open pyeloplasty .", "the hospital stay and convalescence were significantly lower in retroperitoneoscopic group .", "success rate was found to be @ % with @ failure in each group .", "two patients in retroperitoneoscopic group required conversion .", "both groups showed significant improvement in pain score and drainage pattern on diethylene triamine penta-acetic acid scan with decrease in hydronephrosis on ultrasound evaluation .", "although subjective and objective outcomes are equivalent in both the groups , the retroperitoneoscopic approach is associated with significantly less pain , less analgesic requirement , shorter hospital stay and short convalescence in comparison with open pyeloplasty ." ]
to determine the subjective and objective outcomes of retroperitoneoscopic vs open pyeloplasty with minimal incision in a prospective randomized comparison study . in this study between august @ to july @ , @ patients underwent retroperitoneal laparoscopic pyeloplasty and @ open pyeloplasty with minimal incision ( incision length < @ cm ) after randomization . the @ groups were compared for the visual pain score on the first and second postoperative days as the primary end point of the study . complications were recorded and graded using dindo-modified clavien classification of surgical complications . success rates were evaluated by improvement in pain score and objectively by diethylene triamine penta-acetic acid renal scan and other parameters . statistical analysis was performed with spss version @ ( ibm ) with p < @ considered statistically significant . the difference in the visual pain score ( @ vs @ on day @ ; @ vs @ on day @ ) and the diclofenac requirements ( @ vs @ mg ) were statistically significant and more in the open pyeloplasty . the hospital stay and convalescence were significantly lower in retroperitoneoscopic group . success rate was found to be @ % with @ failure in each group . two patients in retroperitoneoscopic group required conversion . both groups showed significant improvement in pain score and drainage pattern on diethylene triamine penta-acetic acid scan with decrease in hydronephrosis on ultrasound evaluation . although subjective and objective outcomes are equivalent in both the groups , the retroperitoneoscopic approach is associated with significantly less pain , less analgesic requirement , shorter hospital stay and short convalescence in comparison with open pyeloplasty .
24,485,998
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the stimulant prodrug lisdexamfetamine dimesylate ( ldx ) is an effective and generally well tolerated treatment for the symptoms of attention-deficit/hyperactivity disorder ( adhd ) .", "positive impacts of ldx on health-related quality of life and functional impairment have previously been demonstrated in a @-week , randomized , double-blind , placebo-controlled , phase iii study in children and adolescents in europe .", "maintenance of these broad benefits , as well as symptomatic control , is a key goal of long-term management of adhd .", "secondary objectives of this multinational study in children and adolescents with adhd were to assess the long-term maintenance of effectiveness of ldx in improving health-related quality of life and reducing functional impairment , as gauged using the child health and illness profile-child edition : parent report form ( chip-ce : prf ) and the weiss functional impairment rating scale-parent report ( wfirs-p ) , respectively .", "patients aged @-@ years with diagnosed adhd and a baseline adhd rating scale iv total score of at least @ were enrolled from the previous european study and from us sites .", "patients who completed an open-label ldx treatment period of at least @ weeks were randomized ( @:@ ) to continue on their optimized dose of ldx or to switch to placebo for a @-week , double-blind , withdrawal period .", "parents completed chip-ce : prf and wfirs-p questionnaires at weeks @ , @ and @ of the open-label period and at weeks @ and @ of the randomized-withdrawal period , or at early termination .", "the endpoint of each period was defined as the last visit with valid data .", "effect sizes were the difference ( ldx minus placebo ) in least-squares ( ls ) - mean change from baseline to endpoint divided by root-mean-square error .", "p values were nominal and not adjusted for multiple comparisons .", "the open-label and randomized full analysis sets comprised @ and @ ( ldx n = @ ; placebo n = @ ) patients , respectively .", "mean pretreatment chip-ce : prf t-scores were more than one standard deviation below the normative mean in four of the five domains , and there was significant improvement across all domains from baseline to endpoint of the open-label period .", "in the randomized-withdrawal period , ls-mean chip-ce : prf t-scores deteriorated in all domains in the placebo group , but not in the ldx group .", "compared with placebo , the effect of ldx was significant in the risk avoidance ( effect size @ ; p < @ ) , achievement ( @ ; p < @ ) and satisfaction ( @ ; p < @ ) domains .", "mean pretreatment wfirs-p scores were lowest in the family domain and the learning and school domain .", "wfirs-p total score and scores in all domains improved significantly from baseline to endpoint of the open-label period .", "in the randomized-withdrawal period , ls-mean scores deteriorated in the placebo group but not in the ldx group .", "compared with placebo , the effect of ldx was significant in the family , learning and school , and risky activities domains and in total ( effect size @ ; p < @ ) .", "using parent-rated instruments , long-term maintenance of the beneficial effect of ldx in multiple domains of health-related quality of life and functional impairment was demonstrated by comparison of treatment continuation and withdrawal under randomized , double-blind , placebo-controlled conditions ." ]
the stimulant prodrug lisdexamfetamine dimesylate ( ldx ) is an effective and generally well tolerated treatment for the symptoms of attention-deficit/hyperactivity disorder ( adhd ) . positive impacts of ldx on health-related quality of life and functional impairment have previously been demonstrated in a @-week , randomized , double-blind , placebo-controlled , phase iii study in children and adolescents in europe . maintenance of these broad benefits , as well as symptomatic control , is a key goal of long-term management of adhd . secondary objectives of this multinational study in children and adolescents with adhd were to assess the long-term maintenance of effectiveness of ldx in improving health-related quality of life and reducing functional impairment , as gauged using the child health and illness profile-child edition : parent report form ( chip-ce : prf ) and the weiss functional impairment rating scale-parent report ( wfirs-p ) , respectively . patients aged @-@ years with diagnosed adhd and a baseline adhd rating scale iv total score of at least @ were enrolled from the previous european study and from us sites . patients who completed an open-label ldx treatment period of at least @ weeks were randomized ( @:@ ) to continue on their optimized dose of ldx or to switch to placebo for a @-week , double-blind , withdrawal period . parents completed chip-ce : prf and wfirs-p questionnaires at weeks @ , @ and @ of the open-label period and at weeks @ and @ of the randomized-withdrawal period , or at early termination . the endpoint of each period was defined as the last visit with valid data . effect sizes were the difference ( ldx minus placebo ) in least-squares ( ls ) - mean change from baseline to endpoint divided by root-mean-square error . p values were nominal and not adjusted for multiple comparisons . the open-label and randomized full analysis sets comprised @ and @ ( ldx n = @ ; placebo n = @ ) patients , respectively . mean pretreatment chip-ce : prf t-scores were more than one standard deviation below the normative mean in four of the five domains , and there was significant improvement across all domains from baseline to endpoint of the open-label period . in the randomized-withdrawal period , ls-mean chip-ce : prf t-scores deteriorated in all domains in the placebo group , but not in the ldx group . compared with placebo , the effect of ldx was significant in the risk avoidance ( effect size @ ; p < @ ) , achievement ( @ ; p < @ ) and satisfaction ( @ ; p < @ ) domains . mean pretreatment wfirs-p scores were lowest in the family domain and the learning and school domain . wfirs-p total score and scores in all domains improved significantly from baseline to endpoint of the open-label period . in the randomized-withdrawal period , ls-mean scores deteriorated in the placebo group but not in the ldx group . compared with placebo , the effect of ldx was significant in the family , learning and school , and risky activities domains and in total ( effect size @ ; p < @ ) . using parent-rated instruments , long-term maintenance of the beneficial effect of ldx in multiple domains of health-related quality of life and functional impairment was demonstrated by comparison of treatment continuation and withdrawal under randomized , double-blind , placebo-controlled conditions .
25,139,785
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the effects of dietary fatty acid supplementation on lipoprotein fatty acid composition have rarely been described .", "sixty-one overweight and obese adults with dyslipidemia and insulin resistance were randomized to placebo , @g/day extended-release nicotinic acid ( ern ) , @g/day prescription omega-@ fatty acid ethyl ester ( p-om@ ) , or combination therapy for @ weeks .", "lipoprotein fatty acid composition was analyzed by gas chromatography pre - and post-treatment .", "treatment with p-om@ or combination , but not ern , increased proportions of eicosapentaenoic acid , docosahexaenoic acid , and docosapentaenoic acid , and reduced those for arachidonic acid in all lipoprotein fractions , with greatest impact in the high-density lipoprotein fraction .", "p-om@-induced changes in eicosapentaenoic acid within low-density lipoproteins and very low-density lipoproteins were associated with beneficial effects on mean arterial pressure and pulse pressure .", "p-om@ supplementation , with or without ern , was associated with differentially altered lipoprotein fatty acid composition and improved blood pressure parameters ." ]
the effects of dietary fatty acid supplementation on lipoprotein fatty acid composition have rarely been described . sixty-one overweight and obese adults with dyslipidemia and insulin resistance were randomized to placebo , @g/day extended-release nicotinic acid ( ern ) , @g/day prescription omega-@ fatty acid ethyl ester ( p-om@ ) , or combination therapy for @ weeks . lipoprotein fatty acid composition was analyzed by gas chromatography pre - and post-treatment . treatment with p-om@ or combination , but not ern , increased proportions of eicosapentaenoic acid , docosahexaenoic acid , and docosapentaenoic acid , and reduced those for arachidonic acid in all lipoprotein fractions , with greatest impact in the high-density lipoprotein fraction . p-om@-induced changes in eicosapentaenoic acid within low-density lipoproteins and very low-density lipoproteins were associated with beneficial effects on mean arterial pressure and pulse pressure . p-om@ supplementation , with or without ern , was associated with differentially altered lipoprotein fatty acid composition and improved blood pressure parameters .
24,378,016
[ "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to evaluate the pharmacokinetics of oral canagliflozin and its o-glucuronide metabolites ( m@ and m@ ) after single and multiple doses in healthy adult participants .", "the pharmacodynamics , safety , and tolerability of canagliflozin were also evaluated .", "in this open-label , single - ( day @ ) and multiple-dose ( days @-@ ) , parallel-group , phase @ study , @ healthy participants were randomized into three groups ( @:@:@ ) to receive @ , @ , or @ mg canagliflozin .", "pharmacokinetics and pharmacodynamics were assessed at pre-pecified timepoints on days @ , @ , and @ .", "mean area under the plasma concentration-time curve , and the maximum observed plasma concentration of canagliflozin , m@ , and m@ increased in a dose-dependent manner , across all the @ doses , following single - and multiple-dose administration .", "the mean apparent elimination half-lives of canagliflozin , m@ , and m@ were independent of the dose .", "canagliflozin decreased the renal threshold for glucose ( rtg ) and increased the urinary glucose excretion ( uge ) in a concentration - and dose-dependent manner .", "the relationship between drug concentrations and rtg was described by a sigmoidal relationship with rtgmin ( minimum value of rtg ) of @ ng/ml ( @ % confidence interval ( ci ) : @ , @ ) and half-maximal effective concentration ( ec@ ) of @ ng/ml ( @ % ci : @ , @ ) .", "no deaths , serious adverse events , hypoglycemic events , or discontinuations due to adverse events were observed .", "pharmacokinetics of canagliflozin and its metabolites ( m@ and m@ ) were linear , and no time-dependent changes were observed after single - and multiple-dose administration .", "similarly , pharmacodynamic effects of canagliflozin on rtg and uge were found to be dose - and concentration-dependent .", "overall , canagliflozin was well-tolerated in healthy participants ." ]
to evaluate the pharmacokinetics of oral canagliflozin and its o-glucuronide metabolites ( m@ and m@ ) after single and multiple doses in healthy adult participants . the pharmacodynamics , safety , and tolerability of canagliflozin were also evaluated . in this open-label , single - ( day @ ) and multiple-dose ( days @-@ ) , parallel-group , phase @ study , @ healthy participants were randomized into three groups ( @:@:@ ) to receive @ , @ , or @ mg canagliflozin . pharmacokinetics and pharmacodynamics were assessed at pre-pecified timepoints on days @ , @ , and @ . mean area under the plasma concentration-time curve , and the maximum observed plasma concentration of canagliflozin , m@ , and m@ increased in a dose-dependent manner , across all the @ doses , following single - and multiple-dose administration . the mean apparent elimination half-lives of canagliflozin , m@ , and m@ were independent of the dose . canagliflozin decreased the renal threshold for glucose ( rtg ) and increased the urinary glucose excretion ( uge ) in a concentration - and dose-dependent manner . the relationship between drug concentrations and rtg was described by a sigmoidal relationship with rtgmin ( minimum value of rtg ) of @ ng/ml ( @ % confidence interval ( ci ) : @ , @ ) and half-maximal effective concentration ( ec@ ) of @ ng/ml ( @ % ci : @ , @ ) . no deaths , serious adverse events , hypoglycemic events , or discontinuations due to adverse events were observed . pharmacokinetics of canagliflozin and its metabolites ( m@ and m@ ) were linear , and no time-dependent changes were observed after single - and multiple-dose administration . similarly , pharmacodynamic effects of canagliflozin on rtg and uge were found to be dose - and concentration-dependent . overall , canagliflozin was well-tolerated in healthy participants .
25,500,487
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "neuroendocrine and immune stresses imposed by chronic sleep restriction are known to be involved in the harmful cardiovascular effects associated with poor sleep .", "despite a well-known beneficial effect of napping on alertness , its effects on neuroendocrine stress and immune responses after sleep restriction are largely unknown .", "this study was a strictly controlled ( sleep-wake status , light environment , caloric intake ) , crossover , randomized design in continuously polysomnography-monitored subjects .", "the study was conducted in a laboratory-based study .", "the subjects were @ healthy young men .", "we investigated the effects on neuroendocrine and immune biomarkers of a night of sleep restricted to @ h followed by a day without naps or with @ minute morning and afternoon naps , both conditions followed by an ad libitum recovery night starting at @:@ .", "salivary interleukin-@ and urinary catecholamines were assessed throughout the daytime study periods .", "the increase in norepinephrine values seen at the end of the afternoon after the sleep-restricted night was not present when the subjects had the opportunity to take naps .", "interleukin-@ changes observed after sleep deprivation were also normalized after napping .", "during the recovery day in the no-nap condition , there were increased levels of afternoon epinephrine and dopamine , which was not the case in the nap condition .", "a recovery night after napping was associated with a reduced amount of slow-wave sleep compared to after the no-nap condition .", "our data suggest that napping has stress-releasing and immune effects .", "napping could be easily applied in real settings as a countermeasure to the detrimental health consequences of sleep debt ." ]
neuroendocrine and immune stresses imposed by chronic sleep restriction are known to be involved in the harmful cardiovascular effects associated with poor sleep . despite a well-known beneficial effect of napping on alertness , its effects on neuroendocrine stress and immune responses after sleep restriction are largely unknown . this study was a strictly controlled ( sleep-wake status , light environment , caloric intake ) , crossover , randomized design in continuously polysomnography-monitored subjects . the study was conducted in a laboratory-based study . the subjects were @ healthy young men . we investigated the effects on neuroendocrine and immune biomarkers of a night of sleep restricted to @ h followed by a day without naps or with @ minute morning and afternoon naps , both conditions followed by an ad libitum recovery night starting at @:@ . salivary interleukin-@ and urinary catecholamines were assessed throughout the daytime study periods . the increase in norepinephrine values seen at the end of the afternoon after the sleep-restricted night was not present when the subjects had the opportunity to take naps . interleukin-@ changes observed after sleep deprivation were also normalized after napping . during the recovery day in the no-nap condition , there were increased levels of afternoon epinephrine and dopamine , which was not the case in the nap condition . a recovery night after napping was associated with a reduced amount of slow-wave sleep compared to after the no-nap condition . our data suggest that napping has stress-releasing and immune effects . napping could be easily applied in real settings as a countermeasure to the detrimental health consequences of sleep debt .
25,668,196
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "prior research has indicated that the loss of skeletal muscle mass and bone mineral density observed with aging is related to the prominent age-related decline in the concentration of serum growth hormone ( gh ) .", "however , there is limited data on the effects of aging on gh responses to acute bouts of heavy resistance exercise ( hre ) and aerobic exercise ( ae ) .", "the present investigation examined the effects of a hre protocol and an ae protocol on immunoreactive gh ( igh ) and bioactive gh ( bgh ) in active young and old women .", "older women had a diminished serum igh response to both the hre and ae protocols compared to the younger women , however a similar response was not observed in serum bgh .", "additionally , the hre protocol elicited a greater bgh response than the ae protocol exclusively in the younger group .", "regardless of exercise mode , aging induces an increase in growth hormone polymerization that specifically results in a loss of serum growth hormone immunoreactivity without a concurrent loss of serum growth hormone bioactivity .", "the greater bgh response to the hre protocol found in the younger group can be attributed to an unknown serum factor of molecular weight between @ and @kd that either potentiated growth hormone bioactivity in response to hre or inhibited growth hormone bioactivity in response to ae ." ]
prior research has indicated that the loss of skeletal muscle mass and bone mineral density observed with aging is related to the prominent age-related decline in the concentration of serum growth hormone ( gh ) . however , there is limited data on the effects of aging on gh responses to acute bouts of heavy resistance exercise ( hre ) and aerobic exercise ( ae ) . the present investigation examined the effects of a hre protocol and an ae protocol on immunoreactive gh ( igh ) and bioactive gh ( bgh ) in active young and old women . older women had a diminished serum igh response to both the hre and ae protocols compared to the younger women , however a similar response was not observed in serum bgh . additionally , the hre protocol elicited a greater bgh response than the ae protocol exclusively in the younger group . regardless of exercise mode , aging induces an increase in growth hormone polymerization that specifically results in a loss of serum growth hormone immunoreactivity without a concurrent loss of serum growth hormone bioactivity . the greater bgh response to the hre protocol found in the younger group can be attributed to an unknown serum factor of molecular weight between @ and @kd that either potentiated growth hormone bioactivity in response to hre or inhibited growth hormone bioactivity in response to ae .
24,786,514
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "behavioral measures are often used to distinguish subgroups of patients with stroke ( eg , to predict treatment gains , stratify clinical trial enrollees , or select rehabilitation therapy ) .", "in studies of the upper extremity , measures of brain function using functional magnetic resonance imaging ( fmri ) have also been found useful , but this approach has not been examined for the lower extremity .", "the current study hypothesized that an fmri-based measure of cortical function would significantly improve prediction of treatment-induced lower extremity behavioral gains .", "biomarkers of treatment gains were also explored .", "patients with hemiparesis @ to @ months after stroke were enrolled in a double-blind , placebo-controlled , randomized clinical trial of ropinirole + physical therapy versus placebo + physical therapy , results of which have previously been reported ( nct@ ) .", "( @ ) primary end point was change in gait velocity .", "enrollees underwent baseline multimodal assessment that included @ measures spanning @ assessment categories ( medical history , impairment , disability , brain injury , and brain function ) , and also underwent reassessment @ weeks after end of therapy .", "in bivariate analysis , @ baseline measures belonging to @ categories ( medical history , impairment , disability , and brain function ) significantly predicted change in gait velocity .", "prediction was strongest , however , using a multivariate model containing @ measures ( leg fugl-meyer score and fmri activation volume within ipsilesional foot sensorimotor cortex ) .", "increased activation volume within bilateral foot primary sensorimotor cortex correlated positively with treatment-induced leg motor gains .", "a multimodal model incorporating behavioral and fmri measures best predicted treatment-induced changes in gait velocity in a clinical trial setting .", "results also suggest potential use of fmri measures as biomarkers of treatment gains ." ]
behavioral measures are often used to distinguish subgroups of patients with stroke ( eg , to predict treatment gains , stratify clinical trial enrollees , or select rehabilitation therapy ) . in studies of the upper extremity , measures of brain function using functional magnetic resonance imaging ( fmri ) have also been found useful , but this approach has not been examined for the lower extremity . the current study hypothesized that an fmri-based measure of cortical function would significantly improve prediction of treatment-induced lower extremity behavioral gains . biomarkers of treatment gains were also explored . patients with hemiparesis @ to @ months after stroke were enrolled in a double-blind , placebo-controlled , randomized clinical trial of ropinirole + physical therapy versus placebo + physical therapy , results of which have previously been reported ( nct@ ) . ( @ ) primary end point was change in gait velocity . enrollees underwent baseline multimodal assessment that included @ measures spanning @ assessment categories ( medical history , impairment , disability , brain injury , and brain function ) , and also underwent reassessment @ weeks after end of therapy . in bivariate analysis , @ baseline measures belonging to @ categories ( medical history , impairment , disability , and brain function ) significantly predicted change in gait velocity . prediction was strongest , however , using a multivariate model containing @ measures ( leg fugl-meyer score and fmri activation volume within ipsilesional foot sensorimotor cortex ) . increased activation volume within bilateral foot primary sensorimotor cortex correlated positively with treatment-induced leg motor gains . a multimodal model incorporating behavioral and fmri measures best predicted treatment-induced changes in gait velocity in a clinical trial setting . results also suggest potential use of fmri measures as biomarkers of treatment gains .
25,070,961
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to investigate the effect of overnight orthokeratology ( ok ) contact lens wear on axial length growth in east asian children with progressive myopia .", "a prospective , randomized , contralateral-eye crossover study conducted over a @-year period .", "we enrolled @ myopic children ( age range , @-@ @ years ) of east asian ethnicity .", "subjects were fitted with overnight ok in @ eye , chosen at random , and conventional rigid gas-permeable ( gp ) lenses for daytime wear in the contralateral eye .", "lenses were worn for @ months .", "after a @-week recovery period without lens wear , lens-eye combinations were reversed and lens wear was continued for a further @ months , followed by another @-week recovery period without lens wear .", "axial eye length was monitored at baseline and every @ months using an iolmaster biometer .", "corneal topography ( medmont e@ ) and objective refraction ( shin-nippon nvision-k @ autorefractor ) were also measured to confirm that ok lens wear was efficacious in correcting myopia .", "axial length elongation and myopia progression with ok were compared with conventional daytime rigid contact lens wear .", "after @ months of lens wear , axial length had increased by @ mm ( meanstandard deviation ) in the gp eye ( p = @ ) but showed no change ( -@ mm ) in the ok eye ( p = @ ) .", "during the second @-month phase of lens wear , in the ok eye there was no change from baseline in axial length at @ months ( -@ mm ; p = @ ) .", "however , in the gp eye , the @-month increase in axial length was significant ( @ mm ; p < @ ) .", "the gp lens-wearing eye showed progressive axial length growth throughout the study .", "these results provide evidence that , at least in the initial months of lens wear , overnight ok inhibits axial eye growth and myopia progression compared with conventional gp lenses .", "apparent shortening of axial length early in ok lens wear may reflect the contribution of ok-induced central corneal thinning , combined with choroidal thickening or recovery due to a reduction or neutralization of the myopiogenic stimulus to eye growth in these myopic children ." ]
to investigate the effect of overnight orthokeratology ( ok ) contact lens wear on axial length growth in east asian children with progressive myopia . a prospective , randomized , contralateral-eye crossover study conducted over a @-year period . we enrolled @ myopic children ( age range , @-@ @ years ) of east asian ethnicity . subjects were fitted with overnight ok in @ eye , chosen at random , and conventional rigid gas-permeable ( gp ) lenses for daytime wear in the contralateral eye . lenses were worn for @ months . after a @-week recovery period without lens wear , lens-eye combinations were reversed and lens wear was continued for a further @ months , followed by another @-week recovery period without lens wear . axial eye length was monitored at baseline and every @ months using an iolmaster biometer . corneal topography ( medmont e@ ) and objective refraction ( shin-nippon nvision-k @ autorefractor ) were also measured to confirm that ok lens wear was efficacious in correcting myopia . axial length elongation and myopia progression with ok were compared with conventional daytime rigid contact lens wear . after @ months of lens wear , axial length had increased by @ mm ( meanstandard deviation ) in the gp eye ( p = @ ) but showed no change ( -@ mm ) in the ok eye ( p = @ ) . during the second @-month phase of lens wear , in the ok eye there was no change from baseline in axial length at @ months ( -@ mm ; p = @ ) . however , in the gp eye , the @-month increase in axial length was significant ( @ mm ; p < @ ) . the gp lens-wearing eye showed progressive axial length growth throughout the study . these results provide evidence that , at least in the initial months of lens wear , overnight ok inhibits axial eye growth and myopia progression compared with conventional gp lenses . apparent shortening of axial length early in ok lens wear may reflect the contribution of ok-induced central corneal thinning , combined with choroidal thickening or recovery due to a reduction or neutralization of the myopiogenic stimulus to eye growth in these myopic children .
25,439,432
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "obsessive-compulsive disorder ( ocd ) is a very disabling condition with a chronic course , if left untreated .", "though cognitive behavioral treatment ( cbt ) with or without selective serotonin reuptake inhibitors ( ssri ) is the method of choice , up to one third of individuals with obsessive-compulsive disorder ( ocd ) do not respond to treatment in terms of at least @ % improvement of symptoms .", "mindfulness based cognitive therapy ( mbct ) is an @-week group program that could help ocd patients with no or only partial response to cbt to reduce oc symptoms and develop a helpful attitude towards obsessions and compulsive urges .", "this study is a prospective , bicentric , assessor-blinded , randomized , actively-controlled clinical trial .", "@ patients with primary diagnosis of ocd according to dsm-iv and no or only partial response to cbt will be recruited from in - and outpatient services as well as online forums and the media .", "patients will be randomized to either an mbct intervention group or to a psycho-educative coaching group ( ocd-ep ) as an active control condition .", "all participants will undergo eight weekly sessions with a length of @ minutes each of a structured group program .", "we hypothesize that mbct will be superior to ocd-ep in reducing obsessive-compulsive symptoms as measured by the yale-brown-obsessive-compulsive scale ( y-bocs ) following the intervention and at @ - and @-months-follow-up .", "secondary outcome measures include depressive symptoms , quality of life , metacognitive beliefs , self-compassion , mindful awareness and approach-avoidance tendencies as measured by an approach avoidance task .", "the results of this study will elucidate the benefits of mbct for ocd patients who did not sufficiently benefit from cbt .", "to our knowledge , this is the first randomized controlled study assessing the effects of mbct on symptom severity and associated parameters in ocd .", "german clinical trials register drks@ .", "registered @ march @ ." ]
obsessive-compulsive disorder ( ocd ) is a very disabling condition with a chronic course , if left untreated . though cognitive behavioral treatment ( cbt ) with or without selective serotonin reuptake inhibitors ( ssri ) is the method of choice , up to one third of individuals with obsessive-compulsive disorder ( ocd ) do not respond to treatment in terms of at least @ % improvement of symptoms . mindfulness based cognitive therapy ( mbct ) is an @-week group program that could help ocd patients with no or only partial response to cbt to reduce oc symptoms and develop a helpful attitude towards obsessions and compulsive urges . this study is a prospective , bicentric , assessor-blinded , randomized , actively-controlled clinical trial . @ patients with primary diagnosis of ocd according to dsm-iv and no or only partial response to cbt will be recruited from in - and outpatient services as well as online forums and the media . patients will be randomized to either an mbct intervention group or to a psycho-educative coaching group ( ocd-ep ) as an active control condition . all participants will undergo eight weekly sessions with a length of @ minutes each of a structured group program . we hypothesize that mbct will be superior to ocd-ep in reducing obsessive-compulsive symptoms as measured by the yale-brown-obsessive-compulsive scale ( y-bocs ) following the intervention and at @ - and @-months-follow-up . secondary outcome measures include depressive symptoms , quality of life , metacognitive beliefs , self-compassion , mindful awareness and approach-avoidance tendencies as measured by an approach avoidance task . the results of this study will elucidate the benefits of mbct for ocd patients who did not sufficiently benefit from cbt . to our knowledge , this is the first randomized controlled study assessing the effects of mbct on symptom severity and associated parameters in ocd . german clinical trials register drks@ . registered @ march @ .
25,403,813
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND" ]
[ "blond and white hair removal by laser is a complicated task with weak satisfactory results due to the deficiency in laser-absorbing chromophore .", "to investigate if repetitive sessions of photodynamic therapy ( pdt ) using external application of liposomal rose bengal ( rb ) photosensitizer followed by intense pulsed light ( ipl ) exposure enables removal of gray and white hair .", "rose bengal loaded in liposomes ( lrb ) was constructed , prepared in hydrogel , and was studied for some pharmaceutical properties .", "penetration and selective hair follicle damage in mice skin were studied .", "topical gel containing lrb was used for treating fifteen adult females who were complaining of facial white terminal hair .", "unwanted facial hair was treated for three sessions at intervals of @-@ weeks using intense pulsed light ( ipl ) .", "at each session , the treatment area was pre-treated with topical lrb gel , while a control group of another @ patients applied placebo gel before ipl treatment .", "evaluations included hair regrowth , which was measured @ weeks after each treatment session and at @ months follow-up by counting the number of terminal hair compared with baseline pretreatment values .", "treatment outcomes and complications if any were also reported .", "average hair regrowth in the lrb group was @ % after @ treatment cycles .", "after six-months follow up , average terminal hair count compared with baseline pretreatment showed @ % reduction and no recorded side effects .", "a significant difference ( p < @ ) was seen compared with the control group ; the clinical results were promising .", "photodynamic hair removal using rose bengal-encapsulated liposomal gel in combination with ipl treatment showed significant efficacy in the treatment of white hair compared with a control group ." ]
blond and white hair removal by laser is a complicated task with weak satisfactory results due to the deficiency in laser-absorbing chromophore . to investigate if repetitive sessions of photodynamic therapy ( pdt ) using external application of liposomal rose bengal ( rb ) photosensitizer followed by intense pulsed light ( ipl ) exposure enables removal of gray and white hair . rose bengal loaded in liposomes ( lrb ) was constructed , prepared in hydrogel , and was studied for some pharmaceutical properties . penetration and selective hair follicle damage in mice skin were studied . topical gel containing lrb was used for treating fifteen adult females who were complaining of facial white terminal hair . unwanted facial hair was treated for three sessions at intervals of @-@ weeks using intense pulsed light ( ipl ) . at each session , the treatment area was pre-treated with topical lrb gel , while a control group of another @ patients applied placebo gel before ipl treatment . evaluations included hair regrowth , which was measured @ weeks after each treatment session and at @ months follow-up by counting the number of terminal hair compared with baseline pretreatment values . treatment outcomes and complications if any were also reported . average hair regrowth in the lrb group was @ % after @ treatment cycles . after six-months follow up , average terminal hair count compared with baseline pretreatment showed @ % reduction and no recorded side effects . a significant difference ( p < @ ) was seen compared with the control group ; the clinical results were promising . photodynamic hair removal using rose bengal-encapsulated liposomal gel in combination with ipl treatment showed significant efficacy in the treatment of white hair compared with a control group .
24,719,063
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "limited data describe patient-reported outcomes ( pros ) of localised oesophageal cancer treated with definitive chemoradiotherapy ( crt ) .", "the phase @/@ scope-@ trial assessed the effectiveness of crtcetuximab .", "the trial for the first time provided an opportunity to describe pros from a multi-centre group of patients treated with crt that are presented here .", "patients undergoing crtcetuximab within the scope-@ trial ( @ patients from @ uk centres ) completed generic - , disease - and treatment-specific health-related quality of life ( hrql ) questionnaires ( eortc qlq-c@ , qlq-oes@ , dermatology life-quality index ( dlqi ) ) at baseline and at @ , @ , @ , @ and @ weeks .", "mean eortc functional scale scores ( > @ point change significant ) , dlqi scores ( > @ point change significant ) and proportions of patients ( > @ % significant ) with ` minimal ' or ` severe ' symptoms are presented .", "questionnaire response rates were good .", "at baseline , eortc functional scores were high ( > @ % ) and few symptoms were reported except for severe problems with fatigue , insomnia and eating-related symptoms ( e.g. , appetite loss , dysphagia , dry mouth ) in both groups ( > @ % ) .", "functional aspects of health deteriorated and symptoms increased with treatment and by week @ global quality of life , physical , role and social function significantly deteriorated and more problems with fatigue , dyspnoea , appetite loss and trouble with taste were reported .", "recovery occurred by @ months ( except severe fatigue and insomnia in > @ % of patients ) and maintained at follow-up with no differences between groups .", "crt for localised oesophageal cancer has a significant detrimental impact on many aspects of hrql ; however , recovery is achieved by @ months and maintained with the exception of persisting problems with severe fatigue and insomnia .", "the data suggest that the hrql recovery after definitive crt is quicker , and there is little lasting deficit compared with treatment including surgery .", "these data need to be compared with hrql data from studies evaluating treatments including surgery for oesophageal cancer ." ]
limited data describe patient-reported outcomes ( pros ) of localised oesophageal cancer treated with definitive chemoradiotherapy ( crt ) . the phase @/@ scope-@ trial assessed the effectiveness of crtcetuximab . the trial for the first time provided an opportunity to describe pros from a multi-centre group of patients treated with crt that are presented here . patients undergoing crtcetuximab within the scope-@ trial ( @ patients from @ uk centres ) completed generic - , disease - and treatment-specific health-related quality of life ( hrql ) questionnaires ( eortc qlq-c@ , qlq-oes@ , dermatology life-quality index ( dlqi ) ) at baseline and at @ , @ , @ , @ and @ weeks . mean eortc functional scale scores ( > @ point change significant ) , dlqi scores ( > @ point change significant ) and proportions of patients ( > @ % significant ) with ` minimal ' or ` severe ' symptoms are presented . questionnaire response rates were good . at baseline , eortc functional scores were high ( > @ % ) and few symptoms were reported except for severe problems with fatigue , insomnia and eating-related symptoms ( e.g. , appetite loss , dysphagia , dry mouth ) in both groups ( > @ % ) . functional aspects of health deteriorated and symptoms increased with treatment and by week @ global quality of life , physical , role and social function significantly deteriorated and more problems with fatigue , dyspnoea , appetite loss and trouble with taste were reported . recovery occurred by @ months ( except severe fatigue and insomnia in > @ % of patients ) and maintained at follow-up with no differences between groups . crt for localised oesophageal cancer has a significant detrimental impact on many aspects of hrql ; however , recovery is achieved by @ months and maintained with the exception of persisting problems with severe fatigue and insomnia . the data suggest that the hrql recovery after definitive crt is quicker , and there is little lasting deficit compared with treatment including surgery . these data need to be compared with hrql data from studies evaluating treatments including surgery for oesophageal cancer .
26,203,761
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "ischemic heart disease is a leading worldwide cause of death .", "the seattle post myocardial infarction model ( spim ) was developed to predict survival @ months to @ years after an acute myocardial infarction with evidence of left ventricular dysfunction .", "a total of @ subjects from the ephesus trial were used to derive the predictive model , while @ subjects from the optimaal trial were used to validate the model .", "cox proportional hazards modeling was used to develop a multivariate risk score predictive of all-cause mortality .", "the spim risk score integrated lab and vital parameters , killip class , reperfusion or revascularization , the number of cardiac evidence-based medicines ( aspirin , statin , blocker , acei/arb , aldosterone blocker ) , and the number of cardiac risk factors .", "the model was predictive of all-cause mortality after myocardial infarction , with an auc of @ at @ months and @ at @ years in the derivation cohort and @ and @ for the same time points in the validation cohort .", "model predicted versus kaplan-meier observed survival was excellent in the derivation cohort .", "it remained so in the validation cohort -- @ % versus @ % at @ years .", "the @ % of subjects with the highest predicted risk had approximately @ times higher mortality at @ years than the @ % of subjects with the lowest predicted risk .", "the spim score was a powerful predictor of outcomes after myocardial infarction with left ventricular dysfunction .", "its highly accurate predictions should improve patient and physician understanding of survival and may prove a useful tool in post-infarct risk stratification ." ]
ischemic heart disease is a leading worldwide cause of death . the seattle post myocardial infarction model ( spim ) was developed to predict survival @ months to @ years after an acute myocardial infarction with evidence of left ventricular dysfunction . a total of @ subjects from the ephesus trial were used to derive the predictive model , while @ subjects from the optimaal trial were used to validate the model . cox proportional hazards modeling was used to develop a multivariate risk score predictive of all-cause mortality . the spim risk score integrated lab and vital parameters , killip class , reperfusion or revascularization , the number of cardiac evidence-based medicines ( aspirin , statin , blocker , acei/arb , aldosterone blocker ) , and the number of cardiac risk factors . the model was predictive of all-cause mortality after myocardial infarction , with an auc of @ at @ months and @ at @ years in the derivation cohort and @ and @ for the same time points in the validation cohort . model predicted versus kaplan-meier observed survival was excellent in the derivation cohort . it remained so in the validation cohort -- @ % versus @ % at @ years . the @ % of subjects with the highest predicted risk had approximately @ times higher mortality at @ years than the @ % of subjects with the lowest predicted risk . the spim score was a powerful predictor of outcomes after myocardial infarction with left ventricular dysfunction . its highly accurate predictions should improve patient and physician understanding of survival and may prove a useful tool in post-infarct risk stratification .
24,562,803
[ "OBJECTIVE", "OBJECTIVE", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to evaluate the effect of finasteride on serum androst-@-ene-@ ,@ - dione ( androstenedione ) and its association with prostate cancer risk among subjects who participated in the prostate cancer prevention trial .", "we analyzed serum androstenedione levels in @ prostate cancer cases and @ controls , nested in the prostate cancer prevention trial , a randomized placebo-controlled trial that found finasteride decreased prostate cancer risk .", "androstenedione is the second most important circulating androgen in men besides testosterone and also a substrate for @-reductase enzyme .", "we observed a @ % increase in androstenedione levels compared with the baseline values in subjects who were treated with finasteride for @ years .", "this significant increase did not vary by case-control status .", "adjusted odds ratio and @ % confidence interval for the third tertile of absolute change in androstenedione levels compared with the first tertile were @ ( @ % confidence interval , @-@ @ ) for low-grade ( gleason score < @ ) cases .", "similar results were observed when analyzed using percent change .", "there were no significant associations between serum androstenedione levels and the risk of high-grade disease .", "the results of this nested case-control study confirm that finasteride blocks the conversion of testosterone to dihydrotestosterone ( dht ) and of androstenedione to @-androstanedione-@ ,@ - dione , which also leads to the reduction of dht formation .", "this decrease in dht may help reduce the risk of low-grade prostate cancer in men .", "our data on a differential effect of androstenedione also suggest that some high-grade prostate cancers may not require androgen for progression ." ]
to evaluate the effect of finasteride on serum androst-@-ene-@ ,@ - dione ( androstenedione ) and its association with prostate cancer risk among subjects who participated in the prostate cancer prevention trial . we analyzed serum androstenedione levels in @ prostate cancer cases and @ controls , nested in the prostate cancer prevention trial , a randomized placebo-controlled trial that found finasteride decreased prostate cancer risk . androstenedione is the second most important circulating androgen in men besides testosterone and also a substrate for @-reductase enzyme . we observed a @ % increase in androstenedione levels compared with the baseline values in subjects who were treated with finasteride for @ years . this significant increase did not vary by case-control status . adjusted odds ratio and @ % confidence interval for the third tertile of absolute change in androstenedione levels compared with the first tertile were @ ( @ % confidence interval , @-@ @ ) for low-grade ( gleason score < @ ) cases . similar results were observed when analyzed using percent change . there were no significant associations between serum androstenedione levels and the risk of high-grade disease . the results of this nested case-control study confirm that finasteride blocks the conversion of testosterone to dihydrotestosterone ( dht ) and of androstenedione to @-androstanedione-@ ,@ - dione , which also leads to the reduction of dht formation . this decrease in dht may help reduce the risk of low-grade prostate cancer in men . our data on a differential effect of androstenedione also suggest that some high-grade prostate cancers may not require androgen for progression .
25,733,274
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "vasopressin and corticosteroids are both commonly used adjunctive therapies in septic shock .", "retrospective analyses have suggested that there may be an interaction between these drugs , with higher circulating vasopressin levels and improved outcomes in patients treated with both vasopressin and corticosteroids .", "we aimed to test for an interaction between vasopressin and corticosteroids in septic shock .", "prospective open-label randomized controlled pilot trial .", "four adult icus in london teaching hospitals .", "sixty-one adult patients who had septic shock .", "initial vasopressin iv infusion titrated up to @ u/min and then iv hydrocortisone ( @ mg @ hourly ) or placebo .", "plasma vasopressin levels were measured at @-@ and @-@ hours after hydrocortisone/placebo administration .", "thirty-one patients were allocated to vasopressin + hydrocortisone and @ patients to vasopressin + placebo .", "the hydrocortisone group required a shorter duration of vasopressin therapy ( @ d ; @ % ci , @-@ @ ; shorter in hydrocortisone group ) and required a lower total dose of vasopressin ( ratio , @ ; @ % ci , @-@ @ ) compared with the placebo group .", "plasma vasopressin levels were not higher in the hydrocortisone group compared with the placebo group ( @ pmol/l difference at @ - to @-hour time point ; @ % ci , -@ to @ pmol/l ) .", "early vasopressin use was well tolerated with only one serious adverse event possibly related to study drug administration reported .", "there were no differences in mortality rates ( @ % @-day mortality in both groups ) or organ failure assessments between the two treatment groups .", "hydrocortisone spared vasopressin requirements , reduced duration , and reduced dose , when used together in the treatment of septic shock , but it did not alter plasma vasopressin levels .", "further trials are needed to assess the clinical effectiveness of vasopressin as the initial vasopressor therapy with or without corticosteroids ." ]
vasopressin and corticosteroids are both commonly used adjunctive therapies in septic shock . retrospective analyses have suggested that there may be an interaction between these drugs , with higher circulating vasopressin levels and improved outcomes in patients treated with both vasopressin and corticosteroids . we aimed to test for an interaction between vasopressin and corticosteroids in septic shock . prospective open-label randomized controlled pilot trial . four adult icus in london teaching hospitals . sixty-one adult patients who had septic shock . initial vasopressin iv infusion titrated up to @ u/min and then iv hydrocortisone ( @ mg @ hourly ) or placebo . plasma vasopressin levels were measured at @-@ and @-@ hours after hydrocortisone/placebo administration . thirty-one patients were allocated to vasopressin + hydrocortisone and @ patients to vasopressin + placebo . the hydrocortisone group required a shorter duration of vasopressin therapy ( @ d ; @ % ci , @-@ @ ; shorter in hydrocortisone group ) and required a lower total dose of vasopressin ( ratio , @ ; @ % ci , @-@ @ ) compared with the placebo group . plasma vasopressin levels were not higher in the hydrocortisone group compared with the placebo group ( @ pmol/l difference at @ - to @-hour time point ; @ % ci , -@ to @ pmol/l ) . early vasopressin use was well tolerated with only one serious adverse event possibly related to study drug administration reported . there were no differences in mortality rates ( @ % @-day mortality in both groups ) or organ failure assessments between the two treatment groups . hydrocortisone spared vasopressin requirements , reduced duration , and reduced dose , when used together in the treatment of septic shock , but it did not alter plasma vasopressin levels . further trials are needed to assess the clinical effectiveness of vasopressin as the initial vasopressor therapy with or without corticosteroids .
24,557,425
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "current holistic rehabilitation blends both physical and psychological techniques .", "however , validation of the usefulness of psychological strategies is limited in the literature .", "to quantify the effects of psychological strategies on both physiologic ( salivary cortisol ) and subjective assessments of stress .", "randomized controlled clinical trial .", "laboratory .", "a total of @ college-aged students ( age = @ @ years ) , most with little to no experience with psychological strategies .", "a @-minute script via an ipod led the participant through visual imagery ( cognitive relaxation ) or deep breathing exercises ( somatic relaxation ) cues .", "the control group listened to @ minutes of ambient nature sounds .", "two samples ( pretest , posttest ) of salivary cortisol were analyzed using an enzyme immunoassay kit ; the average was used for statistical analysis .", "descriptive statistics and correlations were conducted to examine group differences in time of day , salivary cortisol , sex , stress-o-meter values , and perceived stress scale scores .", "salivary cortisol levels were lower in the treatment group than the control group ( f@ ,@ = @ , p < @ ) .", "females had higher scores on both the pretest stress-o-meter ( @ @ ) and the perceived stress scale ( @ @ ) than males ( @ @ and @ @ , respectively ) .", "both cognitive and somatic relaxation strategies reduced cortisol levels .", "participants who received verbal guidance achieved a larger cortisol reduction .", "however , the change in cortisol level was uncorrelated with the change in report of acute stress ; females reported higher levels of stress .", "clinical implications include attention to sex when assessing stress and providing coping skills during the rehabilitation process ." ]
current holistic rehabilitation blends both physical and psychological techniques . however , validation of the usefulness of psychological strategies is limited in the literature . to quantify the effects of psychological strategies on both physiologic ( salivary cortisol ) and subjective assessments of stress . randomized controlled clinical trial . laboratory . a total of @ college-aged students ( age = @ @ years ) , most with little to no experience with psychological strategies . a @-minute script via an ipod led the participant through visual imagery ( cognitive relaxation ) or deep breathing exercises ( somatic relaxation ) cues . the control group listened to @ minutes of ambient nature sounds . two samples ( pretest , posttest ) of salivary cortisol were analyzed using an enzyme immunoassay kit ; the average was used for statistical analysis . descriptive statistics and correlations were conducted to examine group differences in time of day , salivary cortisol , sex , stress-o-meter values , and perceived stress scale scores . salivary cortisol levels were lower in the treatment group than the control group ( f@ ,@ = @ , p < @ ) . females had higher scores on both the pretest stress-o-meter ( @ @ ) and the perceived stress scale ( @ @ ) than males ( @ @ and @ @ , respectively ) . both cognitive and somatic relaxation strategies reduced cortisol levels . participants who received verbal guidance achieved a larger cortisol reduction . however , the change in cortisol level was uncorrelated with the change in report of acute stress ; females reported higher levels of stress . clinical implications include attention to sex when assessing stress and providing coping skills during the rehabilitation process .
24,490,842
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to explore the efficiency of single application of lobaplatin in tran-scatheter arterial chemoembolization ( tace ) for patients with a primary hepatic carcinoma who were unable or unwilling to undergo surgery .", "@ patients with primary hepatic carcinoma diagnosed by imaging or pathology were randomly divided into experimental and control groups and respectively treated with lobaplatin and pirarubicin hydrochloride as chemotherapeutic drugs for tace .", "the amount of iodipin was regulated according to the tumor number and size , and then gelatin sponge or polyvinyl alcohol particles were applied for embolisms .", "the efficiency of treatment in the two groups was compared with reference to survival time and therapeutic response .", "the experimental group ( single lobaplatin as chemotherapy drug ) was superior to control group ( single pirarubicin hydrochloride as chemotherapy drug ) in the aspects of survival time and therapeutic response , with statistical significance .", "single lobaplatin can be as a chemotherapy drug in tace and has better efficiency in the aspects of mean survival time and therapeutic response , deserving to be popularized in the clinic ." ]
to explore the efficiency of single application of lobaplatin in tran-scatheter arterial chemoembolization ( tace ) for patients with a primary hepatic carcinoma who were unable or unwilling to undergo surgery . @ patients with primary hepatic carcinoma diagnosed by imaging or pathology were randomly divided into experimental and control groups and respectively treated with lobaplatin and pirarubicin hydrochloride as chemotherapeutic drugs for tace . the amount of iodipin was regulated according to the tumor number and size , and then gelatin sponge or polyvinyl alcohol particles were applied for embolisms . the efficiency of treatment in the two groups was compared with reference to survival time and therapeutic response . the experimental group ( single lobaplatin as chemotherapy drug ) was superior to control group ( single pirarubicin hydrochloride as chemotherapy drug ) in the aspects of survival time and therapeutic response , with statistical significance . single lobaplatin can be as a chemotherapy drug in tace and has better efficiency in the aspects of mean survival time and therapeutic response , deserving to be popularized in the clinic .
24,568,472
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS" ]
[ "the primary objective of this study was to compare aquacel ( convatec , skillman , new jersey ) , allevyn ( smith & nephew , st petersburg , florida ) , and mediskin i ( mlnlycke , health care ab , gothenburg , sweden ) in the treatment of split-thickness skin graft donor sites .", "this study was performed as a prospective randomized , @-arm , clinical study .", "a clinical study performed at a hand and plastic surgery department with burn unit .", "the study included @ adults with a total of @ donor sites , which were on the thigh , not reharvested , and ranged between @ - and @-cm area .", "subjects were randomly assigned to treatment with aquacel , allevyn , or mediskin i.", "the donor site was assessed on postoperative days @ , @ , and @ for healing , infection , pain , impact on everyday life , ease of use , and cost .", "the obtained results demonstrate significantly faster re-epithelialization for patients treated with aquacel or mediskin i compared with allevyn .", "regarding infections , there were no significant differences between the groups .", "patients wearing aquacel experienced significantly less pain changing the dressing and less impact on everyday life than the patients wearing allevyn .", "aquacel was shown to be significantly easier for the caregiver to use than allevyn and mediskin i.", "there is a significant difference in cost of treatment between the dressings , whereas mediskin i is the most expensive .", "the authors ' results support the use of aquacel in the treatment of split-thickness skin graft donor sites .", "aquacel has a low cost per unit , is user friendly , gives short healing time , and minimizes patient discomfort ." ]
the primary objective of this study was to compare aquacel ( convatec , skillman , new jersey ) , allevyn ( smith & nephew , st petersburg , florida ) , and mediskin i ( mlnlycke , health care ab , gothenburg , sweden ) in the treatment of split-thickness skin graft donor sites . this study was performed as a prospective randomized , @-arm , clinical study . a clinical study performed at a hand and plastic surgery department with burn unit . the study included @ adults with a total of @ donor sites , which were on the thigh , not reharvested , and ranged between @ - and @-cm area . subjects were randomly assigned to treatment with aquacel , allevyn , or mediskin i. the donor site was assessed on postoperative days @ , @ , and @ for healing , infection , pain , impact on everyday life , ease of use , and cost . the obtained results demonstrate significantly faster re-epithelialization for patients treated with aquacel or mediskin i compared with allevyn . regarding infections , there were no significant differences between the groups . patients wearing aquacel experienced significantly less pain changing the dressing and less impact on everyday life than the patients wearing allevyn . aquacel was shown to be significantly easier for the caregiver to use than allevyn and mediskin i. there is a significant difference in cost of treatment between the dressings , whereas mediskin i is the most expensive . the authors ' results support the use of aquacel in the treatment of split-thickness skin graft donor sites . aquacel has a low cost per unit , is user friendly , gives short healing time , and minimizes patient discomfort .
24,343,389
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "there is a higher prevalence of obesity in individuals with mental disorders compared to the general population .", "the results of several studies suggested that weight reduction in this population is possible following psycho-educational and/or behavioural weight management interventions .", "evidence of the effectiveness alone is however inadequate for policy making .", "the aim of the current study was to evaluate the cost-effectiveness of a health promotion intervention targeting physical activity and healthy eating in individuals with mental disorders .", "a markov decision-analytic model using a public payer perspective was applied , projecting the one-year results of a @-week intervention over a time horizon of @ years , assuming a repeated yearly implementation of the programme .", "scenario analysis was applied evaluating the effects on the results of alternative modelling assumptions .", "one-way sensitivity analysis was performed to assess the effects on the results of varying key input parameters .", "an incremental cost-effectiveness ratio of @,@ / quality-adjusted life years ( qaly ) in men , and @,@ / qaly in women was found in the base case .", "scenario analysis assuming an increase in health-related quality of life as a result of the body mass index decrease resulted in much better cost-effectiveness in both men ( @,@ / qaly ) and women ( @,@ / qaly ) .", "the uncertainty associated with the intervention effect had the greatest impact on the model .", "as far as is known to the authors , this is the first health economic evaluation of a health promotion intervention targeting physical activity and healthy eating in individuals with mental disorders .", "such research is important as it provides payers and governments with better insights how to spend the available resources in the most efficient way .", "further research examining the cost-effectiveness of health promotion targeting physical activity and healthy eating in individuals with mental disorders is required ." ]
there is a higher prevalence of obesity in individuals with mental disorders compared to the general population . the results of several studies suggested that weight reduction in this population is possible following psycho-educational and/or behavioural weight management interventions . evidence of the effectiveness alone is however inadequate for policy making . the aim of the current study was to evaluate the cost-effectiveness of a health promotion intervention targeting physical activity and healthy eating in individuals with mental disorders . a markov decision-analytic model using a public payer perspective was applied , projecting the one-year results of a @-week intervention over a time horizon of @ years , assuming a repeated yearly implementation of the programme . scenario analysis was applied evaluating the effects on the results of alternative modelling assumptions . one-way sensitivity analysis was performed to assess the effects on the results of varying key input parameters . an incremental cost-effectiveness ratio of @,@ / quality-adjusted life years ( qaly ) in men , and @,@ / qaly in women was found in the base case . scenario analysis assuming an increase in health-related quality of life as a result of the body mass index decrease resulted in much better cost-effectiveness in both men ( @,@ / qaly ) and women ( @,@ / qaly ) . the uncertainty associated with the intervention effect had the greatest impact on the model . as far as is known to the authors , this is the first health economic evaluation of a health promotion intervention targeting physical activity and healthy eating in individuals with mental disorders . such research is important as it provides payers and governments with better insights how to spend the available resources in the most efficient way . further research examining the cost-effectiveness of health promotion targeting physical activity and healthy eating in individuals with mental disorders is required .
25,134,636
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the aim of this study was to investigate the effects of shock wave therapy on gait pattern in children with hemiplegic cerebral palsy .", "fifteen children were assigned to the study group , whose members received shock wave therapy ( @ shots/muscle , frequency of @hz , energy of @ mj/mm , one session/wk ) .", "another @ were assigned to the control group , whose members participated in a conventional physical therapy exercise program for @ successive months .", "baseline and posttreatment assessments were performed using the modified ashworth scale to evaluate spasticity degrees and using a three-dimensional gait analysis to evaluate gait parameters .", "children in the study group showed a significant improvement when compared with those in the control group ( p < @ ) .", "the modified ashworth scores after treatment were @ ( @ ) and @ ( @ ) for the control and study groups , respectively .", "the gait parameters ( stride length , cadence , speed , cycle time , and stance phase percentage ) after treatment were @ m , @ steps/min , @ m/sec , @ sec , and @ % and @ m , @ steps/min , @ m/sec , @ sec , and @ % for the control group and the study group , respectively .", "shock wave therapy may be a useful tool for improving spasticity and gait pattern in children with hemiplegic cerebral palsy ." ]
the aim of this study was to investigate the effects of shock wave therapy on gait pattern in children with hemiplegic cerebral palsy . fifteen children were assigned to the study group , whose members received shock wave therapy ( @ shots/muscle , frequency of @hz , energy of @ mj/mm , one session/wk ) . another @ were assigned to the control group , whose members participated in a conventional physical therapy exercise program for @ successive months . baseline and posttreatment assessments were performed using the modified ashworth scale to evaluate spasticity degrees and using a three-dimensional gait analysis to evaluate gait parameters . children in the study group showed a significant improvement when compared with those in the control group ( p < @ ) . the modified ashworth scores after treatment were @ ( @ ) and @ ( @ ) for the control and study groups , respectively . the gait parameters ( stride length , cadence , speed , cycle time , and stance phase percentage ) after treatment were @ m , @ steps/min , @ m/sec , @ sec , and @ % and @ m , @ steps/min , @ m/sec , @ sec , and @ % for the control group and the study group , respectively . shock wave therapy may be a useful tool for improving spasticity and gait pattern in children with hemiplegic cerebral palsy .
24,879,552
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to develop and validate composite disease activity scores , based on widely available clinical measures , that would demonstrate improved correlation with detection of synovitis on magnetic resonance imaging ( mri ) and radiographic progression , in comparison with conventional measures , in patients with rheumatoid arthritis ( ra ) .", "this study was conducted as a secondary study of @ ra clinical trials , go-before ( development cohort ) and go-forward ( validation cohort ) .", "generalized estimating equations were used to evaluate independent cross-sectional associations of component variables ( from all time points ) with concurrent mri measures of synovitis and bone edema in the development cohort .", "based on regression coefficients , modified versions of the disease activity score in @ joints ( m-das@ ) , simplified disease activity index ( m-sdai ) , and clinical disease activity index ( m-cdai ) were generated for each subject in the validation cohort .", "the m-das@ , m-sdai , and m-cdai scores were compared to conventional scores of disease activity with regard to associations with mri measures of synovitis and radiographic progression , assessed using pearson 's and spearman 's correlations , linear/logistic regression , and receiver operating characteristic analysis .", "four variables were independently associated with mri-detected synovitis and bone edema in the development cohort : c-reactive protein ( crp ) level , erythrocyte sedimentation rate ( esr ) , swollen joint count in @ joints ( sjc@ ) , and evaluator 's global assessment of disease activity using a visual analog scale ( evga score ) .", "modified disease activity scores were generated using the regression coefficients obtained in the synovitis models for all subjects in the validation cohort ; modified scores were calculated as m-das@ = @ ln ( crp ) + @ sjc@ + @ evga + @ and m-sdai = crp + sjc@ + evga .", "both modified and conventional disease activity scores correlated significantly with mri measures of synovitis .", "modified scores showed superior correlation with synovitis , as compared to conventional scores , at all time points ( p < @ ) .", "furthermore , the m-das@ and m-sdai had superior test characteristics for prediction of radiographic progression at @ weeks ( both p < @ ) .", "modified disease activity scores demonstrated superior correlation with mri detection of synovitis at all time points , and more accurately predicted radiographic progression in patients with ra in a clinical trial setting ." ]
to develop and validate composite disease activity scores , based on widely available clinical measures , that would demonstrate improved correlation with detection of synovitis on magnetic resonance imaging ( mri ) and radiographic progression , in comparison with conventional measures , in patients with rheumatoid arthritis ( ra ) . this study was conducted as a secondary study of @ ra clinical trials , go-before ( development cohort ) and go-forward ( validation cohort ) . generalized estimating equations were used to evaluate independent cross-sectional associations of component variables ( from all time points ) with concurrent mri measures of synovitis and bone edema in the development cohort . based on regression coefficients , modified versions of the disease activity score in @ joints ( m-das@ ) , simplified disease activity index ( m-sdai ) , and clinical disease activity index ( m-cdai ) were generated for each subject in the validation cohort . the m-das@ , m-sdai , and m-cdai scores were compared to conventional scores of disease activity with regard to associations with mri measures of synovitis and radiographic progression , assessed using pearson 's and spearman 's correlations , linear/logistic regression , and receiver operating characteristic analysis . four variables were independently associated with mri-detected synovitis and bone edema in the development cohort : c-reactive protein ( crp ) level , erythrocyte sedimentation rate ( esr ) , swollen joint count in @ joints ( sjc@ ) , and evaluator 's global assessment of disease activity using a visual analog scale ( evga score ) . modified disease activity scores were generated using the regression coefficients obtained in the synovitis models for all subjects in the validation cohort ; modified scores were calculated as m-das@ = @ ln ( crp ) + @ sjc@ + @ evga + @ and m-sdai = crp + sjc@ + evga . both modified and conventional disease activity scores correlated significantly with mri measures of synovitis . modified scores showed superior correlation with synovitis , as compared to conventional scores , at all time points ( p < @ ) . furthermore , the m-das@ and m-sdai had superior test characteristics for prediction of radiographic progression at @ weeks ( both p < @ ) . modified disease activity scores demonstrated superior correlation with mri detection of synovitis at all time points , and more accurately predicted radiographic progression in patients with ra in a clinical trial setting .
24,757,132
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to observe the efficacy in cervical headache of acupuncture combined with fire needling and the simple acupuncture therapy .", "one hundred and eighty cases were randomized into an acupuncture plus fire needling group ( group a ) and an acupuncture group ( group b ) , @ cases in each one .", "baihui ( gv @ ) , wangu ( gb @ ) , fengchi ( gb @ ) , tianzhu ( bl @ ) and neck-jiaji ( ex-b @ ) were selected in the two groups .", "in group a , the fire needling technique was applied to all the above points before acupuncture with filiform needles .", "in group b , the acupuncture therapy was used only .", "the treatment was given once a day , the efficacy was compared between the two groups after @ treatments .", "the total effective rate was @ % ( @/@ ) in group a and was @ % ( @/@ ) in group b , indicating the significant difference in comparison ( p < @ ) .", "vas were @ + / -@ and @ + / - l. @ before and after treatment in group a separately , those were @ + / -@ and @ + / -@ in group b , indicating the significant difference in comparison ( p < @ ) .", "the difference in vas after treatment was significant between the two groups .", "in group a , the follow-up visit was conducted at @ months and @ months after treatment for the cured cases .", "the total recurrence rate in the patients without bony pathological changes was @ % ( @/@ ) and that in the patients with bony pathological changes was @ % ( @/@ ) , there was significant difference between them ( p < @ ) .", "the combined therapy of fire needling technique and filiform needle acupuncture improves the efficacy and sustains the efficacy especially on cervical headache without bony pathological changing ." ]
to observe the efficacy in cervical headache of acupuncture combined with fire needling and the simple acupuncture therapy . one hundred and eighty cases were randomized into an acupuncture plus fire needling group ( group a ) and an acupuncture group ( group b ) , @ cases in each one . baihui ( gv @ ) , wangu ( gb @ ) , fengchi ( gb @ ) , tianzhu ( bl @ ) and neck-jiaji ( ex-b @ ) were selected in the two groups . in group a , the fire needling technique was applied to all the above points before acupuncture with filiform needles . in group b , the acupuncture therapy was used only . the treatment was given once a day , the efficacy was compared between the two groups after @ treatments . the total effective rate was @ % ( @/@ ) in group a and was @ % ( @/@ ) in group b , indicating the significant difference in comparison ( p < @ ) . vas were @ + / -@ and @ + / - l. @ before and after treatment in group a separately , those were @ + / -@ and @ + / -@ in group b , indicating the significant difference in comparison ( p < @ ) . the difference in vas after treatment was significant between the two groups . in group a , the follow-up visit was conducted at @ months and @ months after treatment for the cured cases . the total recurrence rate in the patients without bony pathological changes was @ % ( @/@ ) and that in the patients with bony pathological changes was @ % ( @/@ ) , there was significant difference between them ( p < @ ) . the combined therapy of fire needling technique and filiform needle acupuncture improves the efficacy and sustains the efficacy especially on cervical headache without bony pathological changing .
24,494,285
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "liver-selective thyromimetic agents could provide a new approach for treating dyslipidaemia .", "we performed a multicentre , randomized , placebo-controlled , double-blind study to evaluate the efficacy and safety of eprotirome , a liver-selective thyroid hormone receptor agonist , in @ patients with primary hypercholesterolaemia .", "after previous drug wash-out and dietary run-in , patients received @ or @ g day ( -@ ) eprotirome or placebo for @ weeks .", "the primary end-point was change in serum ldl cholesterol ; secondary end-points included changes in other lipid parameters and safety measures .", "eprotirome treatment at @ and @ g daily reduced serum ldl cholesterol levels by @ @ % and @ @ % , respectively , compared with @ @ % for placebo ( p < @ ) .", "similar reductions were seen in non-hdl cholesterol and apolipoprotein ( apo ) b , whereas serum levels of hdl cholesterol and apo a-i were unchanged .", "there were also considerable reductions in serum triglycerides and lipoprotein ( a ) , in particular in patients with elevated levels at baseline .", "there was no evidence of adverse effects on heart or bone and no changes in serum thyrotropin or triiodothyronine , although the thyroxine level decreased .", "low-grade increases in liver enzymes were evident in most patients .", "in hypercholesterolaemic patients , the liver-selective thyromimetic eprotirome decreased serum levels of atherogenic lipoproteins without signs of extra-hepatic side effects .", "selective stimulation of hepatic thyroid hormone receptors may be an attractive way to modulate lipid metabolism in hyperlipidaemia ." ]
liver-selective thyromimetic agents could provide a new approach for treating dyslipidaemia . we performed a multicentre , randomized , placebo-controlled , double-blind study to evaluate the efficacy and safety of eprotirome , a liver-selective thyroid hormone receptor agonist , in @ patients with primary hypercholesterolaemia . after previous drug wash-out and dietary run-in , patients received @ or @ g day ( -@ ) eprotirome or placebo for @ weeks . the primary end-point was change in serum ldl cholesterol ; secondary end-points included changes in other lipid parameters and safety measures . eprotirome treatment at @ and @ g daily reduced serum ldl cholesterol levels by @ @ % and @ @ % , respectively , compared with @ @ % for placebo ( p < @ ) . similar reductions were seen in non-hdl cholesterol and apolipoprotein ( apo ) b , whereas serum levels of hdl cholesterol and apo a-i were unchanged . there were also considerable reductions in serum triglycerides and lipoprotein ( a ) , in particular in patients with elevated levels at baseline . there was no evidence of adverse effects on heart or bone and no changes in serum thyrotropin or triiodothyronine , although the thyroxine level decreased . low-grade increases in liver enzymes were evident in most patients . in hypercholesterolaemic patients , the liver-selective thyromimetic eprotirome decreased serum levels of atherogenic lipoproteins without signs of extra-hepatic side effects . selective stimulation of hepatic thyroid hormone receptors may be an attractive way to modulate lipid metabolism in hyperlipidaemia .
24,754,313
[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "impulsive decision making is a hallmark of frequently occurring addiction disorders including alcohol dependence ( ad ) .", "therefore , ameliorating impulsive decision making is a promising target for the treatment of ad .", "previous studies have shown that modafinil enhances cognitive control functions in various psychiatric disorders .", "however , the effects of modafinil on delay discounting and its underlying neural correlates have not been investigated as yet .", "the aim of the current study was to investigate the effects of modafinil on neural correlates of impulsive decision making in abstinent ad patients and healthy control ( hc ) subjects .", "a randomized , double-blind , placebo-controlled , within-subjects cross-over study using functional magnetic resonance imaging ( fmri ) was conducted in @ ad patients and @ hc subjects .", "all subjects participated in two fmri sessions in which they either received a single dose of placebo or @mg of modafinil @h before the session .", "during fmri , subjects completed a delay-discounting task to measure impulsive decision making .", "modafinil improved impulsive decision making in ad pateints , which was accompanied by enhanced recruitment of frontoparietal regions and reduced activation of the ventromedial prefrontal cortex .", "moreover , modafinil-induced enhancement of functional connectivity between the superior frontal gyrus and ventral striatum was specifically associated with improvement in impulsive decision making .", "these findings indicate that modafinil can improve impulsive decision making in ad patients through an enhanced coupling of prefrontal control regions and brain regions coding the subjective value of rewards .", "therefore , the current study supports the implementation of modafinil in future clinical trials for ad ." ]
impulsive decision making is a hallmark of frequently occurring addiction disorders including alcohol dependence ( ad ) . therefore , ameliorating impulsive decision making is a promising target for the treatment of ad . previous studies have shown that modafinil enhances cognitive control functions in various psychiatric disorders . however , the effects of modafinil on delay discounting and its underlying neural correlates have not been investigated as yet . the aim of the current study was to investigate the effects of modafinil on neural correlates of impulsive decision making in abstinent ad patients and healthy control ( hc ) subjects . a randomized , double-blind , placebo-controlled , within-subjects cross-over study using functional magnetic resonance imaging ( fmri ) was conducted in @ ad patients and @ hc subjects . all subjects participated in two fmri sessions in which they either received a single dose of placebo or @mg of modafinil @h before the session . during fmri , subjects completed a delay-discounting task to measure impulsive decision making . modafinil improved impulsive decision making in ad pateints , which was accompanied by enhanced recruitment of frontoparietal regions and reduced activation of the ventromedial prefrontal cortex . moreover , modafinil-induced enhancement of functional connectivity between the superior frontal gyrus and ventral striatum was specifically associated with improvement in impulsive decision making . these findings indicate that modafinil can improve impulsive decision making in ad patients through an enhanced coupling of prefrontal control regions and brain regions coding the subjective value of rewards . therefore , the current study supports the implementation of modafinil in future clinical trials for ad .
25,066,449
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "although many attention-deficit/hyperactivity disorder ( adhd ) care models have been studied , few have demonstrated individual-level symptom improvement .", "we sought to test whether complementing basic collaborative care with interventions that address common reasons for symptom persistence improves outcomes for children with inattention and hyperactivity/impulsivity .", "we conducted a randomized comparative effectiveness trial of @ care management systems for @ - to @-year-old children being evaluated for adhd ( n = @ ) .", "all participants received care management with decision support .", "care managers in the enhanced care arm also were trained in motivational and parent management techniques to help parents engage in their child 's treatment , address their own mental health needs , and manage challenging child behaviors .", "we used multivariable models to assess inattention , hyperactivity/impulsivity , oppositionality , and social skills over @ year .", "both treatment arms generated guideline concordant diagnostic processes in @ % of cases ; @ % of children had presentations consistent with adhd .", "for the entire sample , there were no differences in symptom trajectories between study arms ; mean differences in change scores at @ months were -@ ( @ % confidence interval -@ to @ ) for inattention ; -@ ( -@ to @ ) for hyperactivity/impulsivity ; -@ ( -@ to @ ) for oppositionality ; and @ ( -@ to @ ) for social skills .", "among children with adhd-consistent presentations , enhanced arm participants experienced superior change scores for hyperactivity/impulsivity of -@ ( -@ to -@ ) , oppositionality -@ ( -@ to -@ ) , and social skills @ ( @ to @ ) .", "among children with adhd-consistent presentations , addressing barriers to engagement with care and challenging child behaviors has potential to improve the effectiveness of collaborative care ." ]
although many attention-deficit/hyperactivity disorder ( adhd ) care models have been studied , few have demonstrated individual-level symptom improvement . we sought to test whether complementing basic collaborative care with interventions that address common reasons for symptom persistence improves outcomes for children with inattention and hyperactivity/impulsivity . we conducted a randomized comparative effectiveness trial of @ care management systems for @ - to @-year-old children being evaluated for adhd ( n = @ ) . all participants received care management with decision support . care managers in the enhanced care arm also were trained in motivational and parent management techniques to help parents engage in their child 's treatment , address their own mental health needs , and manage challenging child behaviors . we used multivariable models to assess inattention , hyperactivity/impulsivity , oppositionality , and social skills over @ year . both treatment arms generated guideline concordant diagnostic processes in @ % of cases ; @ % of children had presentations consistent with adhd . for the entire sample , there were no differences in symptom trajectories between study arms ; mean differences in change scores at @ months were -@ ( @ % confidence interval -@ to @ ) for inattention ; -@ ( -@ to @ ) for hyperactivity/impulsivity ; -@ ( -@ to @ ) for oppositionality ; and @ ( -@ to @ ) for social skills . among children with adhd-consistent presentations , enhanced arm participants experienced superior change scores for hyperactivity/impulsivity of -@ ( -@ to -@ ) , oppositionality -@ ( -@ to -@ ) , and social skills @ ( @ to @ ) . among children with adhd-consistent presentations , addressing barriers to engagement with care and challenging child behaviors has potential to improve the effectiveness of collaborative care .
25,802,346
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "fish oil supplementation has been shown to alter gene expression of mononuclear cells both in vitro and in vivo .", "however , little is known about the total transcriptome profile in healthy subjects after intake of fish oil .", "we therefore investigated the gene expression profile in peripheral blood mononuclear cells ( pbmcs ) after intake of fish oil for @ weeks using transcriptome analyses .", "in a @-week , double-blinded , randomized , controlled , parallel-group study , healthy subjects received @ g day ( -@ ) fish oil ( @ g day ( -@ ) eicosapentaenoic acid + docosahexaenoic acid ) ( n = @ ) or @ g day ( -@ ) high oleic sunflower oil ( n = @ ) .", "microarray analyses of rna isolated from pbmcs were performed at baseline and after @ weeks of intervention .", "cell cycle , dna packaging and chromosome organization are biological processes found to be upregulated after intake of fish oil compared to high oleic sunflower oil using a moderated t-test .", "in addition , gene set enrichment analysis identified several enriched gene sets after intake of fish oil .", "the genes contributing to the significantly different gene sets in the subjects given fish oil compared with the control group are involved in cell cycle , endoplasmic reticulum ( er ) stress and apoptosis .", "gene transcripts with common motifs for @ known transcription factors including e@f , tp@ and atf@ were upregulated after intake of fish oil .", "we have shown that intake of fish oil for @ weeks modulates gene expression in pbmcs of healthy subjects .", "the increased expression of genes related to cell cycle , er stress and apoptosis suggests that intake of fish oil may modulate basic cellular processes involved in normal cellular function ." ]
fish oil supplementation has been shown to alter gene expression of mononuclear cells both in vitro and in vivo . however , little is known about the total transcriptome profile in healthy subjects after intake of fish oil . we therefore investigated the gene expression profile in peripheral blood mononuclear cells ( pbmcs ) after intake of fish oil for @ weeks using transcriptome analyses . in a @-week , double-blinded , randomized , controlled , parallel-group study , healthy subjects received @ g day ( -@ ) fish oil ( @ g day ( -@ ) eicosapentaenoic acid + docosahexaenoic acid ) ( n = @ ) or @ g day ( -@ ) high oleic sunflower oil ( n = @ ) . microarray analyses of rna isolated from pbmcs were performed at baseline and after @ weeks of intervention . cell cycle , dna packaging and chromosome organization are biological processes found to be upregulated after intake of fish oil compared to high oleic sunflower oil using a moderated t-test . in addition , gene set enrichment analysis identified several enriched gene sets after intake of fish oil . the genes contributing to the significantly different gene sets in the subjects given fish oil compared with the control group are involved in cell cycle , endoplasmic reticulum ( er ) stress and apoptosis . gene transcripts with common motifs for @ known transcription factors including e@f , tp@ and atf@ were upregulated after intake of fish oil . we have shown that intake of fish oil for @ weeks modulates gene expression in pbmcs of healthy subjects . the increased expression of genes related to cell cycle , er stress and apoptosis suggests that intake of fish oil may modulate basic cellular processes involved in normal cellular function .
24,641,624
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "despite increasing trends toward the early initiation of oral feeding after gastrointestinal ( gi ) surgeries , current evidence has not been convincing .", "the present randomized clinical trial aimed to compare the clinical outcomes of early oral feeding ( eof ) with late oral feeding ( lof ) following surgery for upper gi tumors .", "one hundred and nine consecutive patients with esophageal or gastric tumors undergoing surgical resection in two hospitals in tehran , iran , were enrolled in this prospective randomized controlled trial , and were randomly assigned to a group starting eof on the first postoperative day and another group that remained nil by mouth until the return of bowel sounds ( lof group ) .", "the clinical and surgical outcomes were compared between the two groups .", "the clinical outcomes were significantly better in the patients in the eof group ( p < @ ) .", "repeated nil per os ( @ vs. @ % ) and re-hospitalization ( @ vs. @ % ) were more common in lof group ( p < @ ) .", "additionally , gas passage , nasogastric tube ( ngt ) discharge , a decrease in intravenous serum to less than @ ml per day , the time to start a soft diet and hospital discharge following surgery occurred significantly earlier in the eof group than in the lof group ( p < @ ) .", "early oral feeding after the surgical resection of esophageal and gastric tumors is safe , and is associated with favorable early in-hospital outcomes and a sooner return to physiological gi function and hospital discharge ." ]
despite increasing trends toward the early initiation of oral feeding after gastrointestinal ( gi ) surgeries , current evidence has not been convincing . the present randomized clinical trial aimed to compare the clinical outcomes of early oral feeding ( eof ) with late oral feeding ( lof ) following surgery for upper gi tumors . one hundred and nine consecutive patients with esophageal or gastric tumors undergoing surgical resection in two hospitals in tehran , iran , were enrolled in this prospective randomized controlled trial , and were randomly assigned to a group starting eof on the first postoperative day and another group that remained nil by mouth until the return of bowel sounds ( lof group ) . the clinical and surgical outcomes were compared between the two groups . the clinical outcomes were significantly better in the patients in the eof group ( p < @ ) . repeated nil per os ( @ vs. @ % ) and re-hospitalization ( @ vs. @ % ) were more common in lof group ( p < @ ) . additionally , gas passage , nasogastric tube ( ngt ) discharge , a decrease in intravenous serum to less than @ ml per day , the time to start a soft diet and hospital discharge following surgery occurred significantly earlier in the eof group than in the lof group ( p < @ ) . early oral feeding after the surgical resection of esophageal and gastric tumors is safe , and is associated with favorable early in-hospital outcomes and a sooner return to physiological gi function and hospital discharge .
24,875,466
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to examine whether socioeconomic position ( sep ) was associated with change in cardiovascular risk factors and meeting treatment targets for cardiovascular risk factors among individuals with screen-detected type @ dm at six-year follow-up .", "the study population was @ people with type @ dm identified from at stepwise diabetes screening programme in general practice during @-@ in the addition-denmark study .", "the addition-study was performed as a randomised trial but the two randomisation groups were analysed as one cohort in this study .", "cardiovascular risk factors were measured at baseline and repeated at follow-up ( mean : @ -lsb- @ -rsb- years ) .", "information on sep , redeemed antihypertensive and lipid-lowering treatment were obtained from danish registers .", "multivariate analyses were performed to estimate change in cardiovascular risk factors and difference in meeting treatment targets .", "the change in hba@c , cholesterol , blood pressure and bmi were virtually the same across educational level , income level , occupational status or cohabiting status .", "overall , the ability to meet treatment targets for hba@c , cholesterol and blood pressure was not modified by sep-group .", "a higher proportion of people with lower educational level or lower income level in the intensive care redeemed anti-hypertensive treatment compared to people with higher educational or income levels .", "screen-detection and early treatment onset did not introduce socioeconomic inequality in metabolic control in people with screen-detected type @ dm at six-year follow-up ." ]
to examine whether socioeconomic position ( sep ) was associated with change in cardiovascular risk factors and meeting treatment targets for cardiovascular risk factors among individuals with screen-detected type @ dm at six-year follow-up . the study population was @ people with type @ dm identified from at stepwise diabetes screening programme in general practice during @-@ in the addition-denmark study . the addition-study was performed as a randomised trial but the two randomisation groups were analysed as one cohort in this study . cardiovascular risk factors were measured at baseline and repeated at follow-up ( mean : @ -lsb- @ -rsb- years ) . information on sep , redeemed antihypertensive and lipid-lowering treatment were obtained from danish registers . multivariate analyses were performed to estimate change in cardiovascular risk factors and difference in meeting treatment targets . the change in hba@c , cholesterol , blood pressure and bmi were virtually the same across educational level , income level , occupational status or cohabiting status . overall , the ability to meet treatment targets for hba@c , cholesterol and blood pressure was not modified by sep-group . a higher proportion of people with lower educational level or lower income level in the intensive care redeemed anti-hypertensive treatment compared to people with higher educational or income levels . screen-detection and early treatment onset did not introduce socioeconomic inequality in metabolic control in people with screen-detected type @ dm at six-year follow-up .
24,613,817
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to assess the efficacy of a financial incentive added to routine specialist pregnancy stop smoking services versus routine care to help pregnant smokers quit .", "phase ii therapeutic exploratory single centre , individually randomised controlled parallel group superiority trial .", "one large health board area with a materially deprived , inner city population in the west of scotland , united kingdom .", "@ self reported pregnant smokers in nhs greater glasgow and clyde who were english speaking , at least @ years of age , less than @ weeks pregnant , and had an exhaled carbon monoxide breath test result of @ ppm or more .", "@ women were randomised to incentives and @ to control .", "the control group received routine care , which was the offer of a face to face appointment to discuss smoking and cessation and , for those who attended and set a quit date , the offer of free nicotine replacement therapy for @ weeks provided by pharmacy services , and four , weekly support phone calls .", "the intervention group received routine care plus the offer of up to @ of shopping vouchers : @ for attending a face to face appointment and setting a quit date ; then another @ if at four weeks ' post-quit date exhaled carbon monoxide confirmed quitting ; a further @ was provided for continued validated abstinence of exhaled carbon monoxide after @ weeks ; a final @ voucher was provided for validated abstinence of exhaled carbon monoxide at @-@ weeks ' gestation .", "the primary outcome was cotinine verified cessation at @-@ weeks ' gestation through saliva ( < @ ng/ml ) or urine ( < @ ng/ml ) .", "secondary outcomes included birth weight , engagement , and self reported quit at four weeks .", "recruitment was extended from @ to @ months to achieve the target sample size .", "follow-up continued until september @ .", "of the @ women randomised , three controls opted out soon after enrolment ; these women did not want their data to be used , leaving @ intervention and @ control group participants in the intention to treat analysis .", "no harms of financial incentives were documented .", "significantly more smokers in the incentives group than control group stopped smoking : @ ( @ % ) versus @ ( @ % ) .", "the relative risk of not smoking at the end of pregnancy was @ ( @ % confidence interval @ to @ ) p < @ .", "the absolute risk difference was @ % ( @ % confidence interval @ % to @ % ) .", "the number needed to treat ( where financial incentives need to be offered to achieve one extra quitter in late pregnancy ) was @ ( @ % confidence interval @ to @ ) .", "the mean birth weight was @ g ( sd @ g ) in the incentives group and @ ( sd @ ) g in the control group ( p = @ ) .", "this phase ii randomised controlled trial provides substantial evidence for the efficacy of incentives for smoking cessation in pregnancy ; as this was only a single centre trial , incentives should now be tested in different types of pregnancy cessation services and in different parts of the united kingdom .", "current controlled trials isrctn@ ." ]
to assess the efficacy of a financial incentive added to routine specialist pregnancy stop smoking services versus routine care to help pregnant smokers quit . phase ii therapeutic exploratory single centre , individually randomised controlled parallel group superiority trial . one large health board area with a materially deprived , inner city population in the west of scotland , united kingdom . @ self reported pregnant smokers in nhs greater glasgow and clyde who were english speaking , at least @ years of age , less than @ weeks pregnant , and had an exhaled carbon monoxide breath test result of @ ppm or more . @ women were randomised to incentives and @ to control . the control group received routine care , which was the offer of a face to face appointment to discuss smoking and cessation and , for those who attended and set a quit date , the offer of free nicotine replacement therapy for @ weeks provided by pharmacy services , and four , weekly support phone calls . the intervention group received routine care plus the offer of up to @ of shopping vouchers : @ for attending a face to face appointment and setting a quit date ; then another @ if at four weeks ' post-quit date exhaled carbon monoxide confirmed quitting ; a further @ was provided for continued validated abstinence of exhaled carbon monoxide after @ weeks ; a final @ voucher was provided for validated abstinence of exhaled carbon monoxide at @-@ weeks ' gestation . the primary outcome was cotinine verified cessation at @-@ weeks ' gestation through saliva ( < @ ng/ml ) or urine ( < @ ng/ml ) . secondary outcomes included birth weight , engagement , and self reported quit at four weeks . recruitment was extended from @ to @ months to achieve the target sample size . follow-up continued until september @ . of the @ women randomised , three controls opted out soon after enrolment ; these women did not want their data to be used , leaving @ intervention and @ control group participants in the intention to treat analysis . no harms of financial incentives were documented . significantly more smokers in the incentives group than control group stopped smoking : @ ( @ % ) versus @ ( @ % ) . the relative risk of not smoking at the end of pregnancy was @ ( @ % confidence interval @ to @ ) p < @ . the absolute risk difference was @ % ( @ % confidence interval @ % to @ % ) . the number needed to treat ( where financial incentives need to be offered to achieve one extra quitter in late pregnancy ) was @ ( @ % confidence interval @ to @ ) . the mean birth weight was @ g ( sd @ g ) in the incentives group and @ ( sd @ ) g in the control group ( p = @ ) . this phase ii randomised controlled trial provides substantial evidence for the efficacy of incentives for smoking cessation in pregnancy ; as this was only a single centre trial , incentives should now be tested in different types of pregnancy cessation services and in different parts of the united kingdom . current controlled trials isrctn@ .
25,627,664
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]
[ "to compare the efficacy and safety of the intraocular lens ( iol ) - shell procedure versus conventional phacoemulsification for the surgical treatment of dense cataracts .", "eighty eyes with dense nuclear cataracts were enrolled in a prospective , randomized controlled study .", "patients were assigned to two groups .", "in group i , the iol was traditionally implanted after all nuclear fragments were completely removed , and in group ii , the iol was innovatively implanted in the bag before the last residual nuclear fragment was removed .", "this novel adjusted surgical procedure , named the `` iol-shell technique '' , features use of the iol as a protective barrier rather than simply as a refractive alternative , and it is conceptually different from the traditional step-by-step procedure .", "clinical examinations , including uncorrected visual acuity , central corneal thickness ( cct ) , temporal clear corneal incision thickness and corneal endothelial cell density , were carried out .", "the inter-group difference in temporal corneal thickness was found to be of no statistical significance at any of the visits .", "compared to eyes in group i , those in group ii were shown to have significantly less corneal endothelial cell loss on both the @th and @th day following surgery .", "at @ days after surgery , the mean corneal endothelial cell loss in group ii was @ % , compared to @ % in group i ( p < @ ) .", "the mean endothelial cell loss measured on postoperative day @ was @ % in group ii compared to @ % in group i ( p < @ ) .", "on the @st day after surgery , the mean cct of eyes in group ii was significantly smaller compared to group i ( group i vs. group ii : @ % vs. @ % , p < @ ) .", "compared to conventional phacoemulsification , the iol-shell technique was shown to be a relatively safer procedure without compromised efficiency for dense cataracts , and it caused less corneal endothelial cell loss and milder postoperative corneal edema ( clinical trials identifier : nct@ ) .", "clinicaltrials.gov nct@ ." ]
to compare the efficacy and safety of the intraocular lens ( iol ) - shell procedure versus conventional phacoemulsification for the surgical treatment of dense cataracts . eighty eyes with dense nuclear cataracts were enrolled in a prospective , randomized controlled study . patients were assigned to two groups . in group i , the iol was traditionally implanted after all nuclear fragments were completely removed , and in group ii , the iol was innovatively implanted in the bag before the last residual nuclear fragment was removed . this novel adjusted surgical procedure , named the `` iol-shell technique '' , features use of the iol as a protective barrier rather than simply as a refractive alternative , and it is conceptually different from the traditional step-by-step procedure . clinical examinations , including uncorrected visual acuity , central corneal thickness ( cct ) , temporal clear corneal incision thickness and corneal endothelial cell density , were carried out . the inter-group difference in temporal corneal thickness was found to be of no statistical significance at any of the visits . compared to eyes in group i , those in group ii were shown to have significantly less corneal endothelial cell loss on both the @th and @th day following surgery . at @ days after surgery , the mean corneal endothelial cell loss in group ii was @ % , compared to @ % in group i ( p < @ ) . the mean endothelial cell loss measured on postoperative day @ was @ % in group ii compared to @ % in group i ( p < @ ) . on the @st day after surgery , the mean cct of eyes in group ii was significantly smaller compared to group i ( group i vs. group ii : @ % vs. @ % , p < @ ) . compared to conventional phacoemulsification , the iol-shell technique was shown to be a relatively safer procedure without compromised efficiency for dense cataracts , and it caused less corneal endothelial cell loss and milder postoperative corneal edema ( clinical trials identifier : nct@ ) . clinicaltrials.gov nct@ .
25,401,512
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]
[ "early prognostication after successful cardiopulmonary resuscitation is difficult , and there is a need for novel methods to estimate the extent of brain injury and predict outcome .", "in this study , we evaluated the impact of the cardiac arrest syndrome on the plasma levels of selected tissue-specific micrornas ( mirnas ) and assessed their ability to prognosticate death and neurological disability .", "we included @ patients treated with hypothermia after cardiac arrest in the study .", "blood samples were obtained at @ hours and at @ hours .", "for mirna-screening purposes , custom quantitative polymerase chain reaction ( qpcr ) panels were first used .", "thereafter individual mirnas were assessed at @ hours with qpcr .", "mirnas that successfully predicted prognosis at @ hours were further analysed at @ hours .", "outcomes were measured according to the cerebral performance category ( cpc ) score at @ months after cardiac arrest and stratified into good ( cpc score @ or @ ) or poor ( cpc scores @ to @ ) .", "at @ hours , mir-@a , mir-@ , mir-@b , mir-@ , mir-@ and mir-@ did not differ between the good and poor neurological outcome groups .", "in contrast , mir-@ was significantly elevated in patients with poor outcomes compared with those with favourable outcomes ( p < @ ) at @ hours and @ hours after cardiac arrest .", "analysis of receiver operating characteristic curves at @ and @ hours after cardiac arrest showed areas under the curve of @ ( @ % confidence interval ( ci ) = @ to @ ) and @ ( @ % ci = @ to @ ) , respectively .", "the brain-enriched mirna mir-@ is a promising novel biomarker for prediction of neurological prognosis following cardiac arrest ." ]
early prognostication after successful cardiopulmonary resuscitation is difficult , and there is a need for novel methods to estimate the extent of brain injury and predict outcome . in this study , we evaluated the impact of the cardiac arrest syndrome on the plasma levels of selected tissue-specific micrornas ( mirnas ) and assessed their ability to prognosticate death and neurological disability . we included @ patients treated with hypothermia after cardiac arrest in the study . blood samples were obtained at @ hours and at @ hours . for mirna-screening purposes , custom quantitative polymerase chain reaction ( qpcr ) panels were first used . thereafter individual mirnas were assessed at @ hours with qpcr . mirnas that successfully predicted prognosis at @ hours were further analysed at @ hours . outcomes were measured according to the cerebral performance category ( cpc ) score at @ months after cardiac arrest and stratified into good ( cpc score @ or @ ) or poor ( cpc scores @ to @ ) . at @ hours , mir-@a , mir-@ , mir-@b , mir-@ , mir-@ and mir-@ did not differ between the good and poor neurological outcome groups . in contrast , mir-@ was significantly elevated in patients with poor outcomes compared with those with favourable outcomes ( p < @ ) at @ hours and @ hours after cardiac arrest . analysis of receiver operating characteristic curves at @ and @ hours after cardiac arrest showed areas under the curve of @ ( @ % confidence interval ( ci ) = @ to @ ) and @ ( @ % ci = @ to @ ) , respectively . the brain-enriched mirna mir-@ is a promising novel biomarker for prediction of neurological prognosis following cardiac arrest .
24,588,965
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "we compare attribution and social comparison theories as potential explanations for attitudes towards overweight and underweight targets among australian university students .", "@ female students ( median age @ ) completed a measure of body image state , then read one of six vignettes , describing a female student who was underweight , average weight or overweight , and who did or did not have a medical condition affecting weight .", "independent variables were target weight ( underweight , average-weight , overweight ) ; weight controllability ( no information , uncontrollable ) ; and participant body image ( higher , lower ) .", "participants evaluated the target on six characteristics derived from existing research on weight bias , on seven-point likert scales : attractive ; healthy ; likeable ; motivated ; self-disciplined ; having willpower .", "a three-way between-participants multivariate analysis of covariance was conducted , with post hoc comparisons of significant effects .", "overweight targets were rated more negatively than average-weight and underweight targets .", "uncontrollability ( medical ) information produced more positive evaluations of the overweight target , but more negative evaluations of the underweight target .", "ratings of the average-weight target were not influenced by uncontrollability information .", "participant body image state had no significant effects .", "results provided partial support for attribution theory , but not for social comparison theory , as an explanation of weight bias ." ]
we compare attribution and social comparison theories as potential explanations for attitudes towards overweight and underweight targets among australian university students . @ female students ( median age @ ) completed a measure of body image state , then read one of six vignettes , describing a female student who was underweight , average weight or overweight , and who did or did not have a medical condition affecting weight . independent variables were target weight ( underweight , average-weight , overweight ) ; weight controllability ( no information , uncontrollable ) ; and participant body image ( higher , lower ) . participants evaluated the target on six characteristics derived from existing research on weight bias , on seven-point likert scales : attractive ; healthy ; likeable ; motivated ; self-disciplined ; having willpower . a three-way between-participants multivariate analysis of covariance was conducted , with post hoc comparisons of significant effects . overweight targets were rated more negatively than average-weight and underweight targets . uncontrollability ( medical ) information produced more positive evaluations of the overweight target , but more negative evaluations of the underweight target . ratings of the average-weight target were not influenced by uncontrollability information . participant body image state had no significant effects . results provided partial support for attribution theory , but not for social comparison theory , as an explanation of weight bias .
25,117,063
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "severe anaemia in children is a leading cause of hospital admission and a major cause of mortality in sub-saharan africa , yet there are limited published data on blood transfusion in this vulnerable group .", "we present data from a large controlled trial of fluid resuscitation ( fluid expansion as supportive therapy ( feast ) trial ) on the prevalence , clinical features , and transfusion management of anaemia in children presenting to hospitals in three east african countries with serious febrile illness ( predominantly malaria and/or sepsis ) and impaired peripheral perfusion .", "of @,@ children in the feast trial , @,@ ( @ % ) had baseline haemoglobin ( hb ) measurement , @,@ / @,@ ( @ % ) were anaemic ( hb < @ g/dl ) , and @ % severely anaemic ( hb < @ g/dl ) .", "prevalence of severe anaemia varied from @ % in kenya to @ % in eastern uganda .", "@,@ / @,@ ( @ % ) children were transfused ( @ % within @ hours ) .", "adherence to who transfusion guidelines was poor .", "among severely anaemic children who were not transfused , @ % ( @/@ ) died within @ hours , and @ % of these deaths occurred within @ hours of randomisation .", "by @ hours , @/@ ,@ ( @ % ) severely anaemic children had died , compared to @/@ ( @ % ) and @/@ ( @ % ) of those with moderate and mild anaemia , respectively .", "among children without severe hypotension who were randomised to receive fluid boluses of @ % saline or albumin , mortality was increased ( @ % and @ % , respectively ) compared to controls ( @ % ) , regardless of admission hb level .", "repeat transfusion varied from @ % in kenya/tanzania to @ to @ % at the four ugandan centres .", "adverse reactions to blood were rare ( @ % ) .", "severe anaemia complicates one third of childhood admissions with serious febrile illness to hospitals in east africa , and is associated with increased mortality .", "a high proportion of deaths occurred within @ hours of admission , emphasizing the need for rapid recognition and prompt blood transfusion .", "adherence to current who transfusion guidelines was poor .", "the high rates of re-transfusion suggest that @ ml/kg whole blood or @ ml/kg packed cells may undertreat a significant proportion of anaemic children .", "future evaluation of the impact of a larger volume of transfused blood and optimum transfusion management of children with hb of < @ g/dl is warranted ." ]
severe anaemia in children is a leading cause of hospital admission and a major cause of mortality in sub-saharan africa , yet there are limited published data on blood transfusion in this vulnerable group . we present data from a large controlled trial of fluid resuscitation ( fluid expansion as supportive therapy ( feast ) trial ) on the prevalence , clinical features , and transfusion management of anaemia in children presenting to hospitals in three east african countries with serious febrile illness ( predominantly malaria and/or sepsis ) and impaired peripheral perfusion . of @,@ children in the feast trial , @,@ ( @ % ) had baseline haemoglobin ( hb ) measurement , @,@ / @,@ ( @ % ) were anaemic ( hb < @ g/dl ) , and @ % severely anaemic ( hb < @ g/dl ) . prevalence of severe anaemia varied from @ % in kenya to @ % in eastern uganda . @,@ / @,@ ( @ % ) children were transfused ( @ % within @ hours ) . adherence to who transfusion guidelines was poor . among severely anaemic children who were not transfused , @ % ( @/@ ) died within @ hours , and @ % of these deaths occurred within @ hours of randomisation . by @ hours , @/@ ,@ ( @ % ) severely anaemic children had died , compared to @/@ ( @ % ) and @/@ ( @ % ) of those with moderate and mild anaemia , respectively . among children without severe hypotension who were randomised to receive fluid boluses of @ % saline or albumin , mortality was increased ( @ % and @ % , respectively ) compared to controls ( @ % ) , regardless of admission hb level . repeat transfusion varied from @ % in kenya/tanzania to @ to @ % at the four ugandan centres . adverse reactions to blood were rare ( @ % ) . severe anaemia complicates one third of childhood admissions with serious febrile illness to hospitals in east africa , and is associated with increased mortality . a high proportion of deaths occurred within @ hours of admission , emphasizing the need for rapid recognition and prompt blood transfusion . adherence to current who transfusion guidelines was poor . the high rates of re-transfusion suggest that @ ml/kg whole blood or @ ml/kg packed cells may undertreat a significant proportion of anaemic children . future evaluation of the impact of a larger volume of transfused blood and optimum transfusion management of children with hb of < @ g/dl is warranted .
25,640,706
[ "BACKGROUND", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to assess long-term superiority in terms of chronic pain between prolene hernia system ( phs ) , mesh plug repair ( mpr ) and lichtenstein ( l ) technique for inguinal hernia repair .", "eight years after randomizing three commonly used techniques for primary inguinal hernia repair , the outcome was evaluated with a questionnaire measuring pain on verbal descriptor and visual analogue scales , including limitations on daily life activities , sensory disturbances and recurrences .", "from previous results patients characteristics , operative details and short - and mid-term pain outcome were extracted .", "@ out of @ eligible patients ( @ % ) completed the follow-up after median @ years ( range @-@ @ ) after the inguinal hernia operation .", "no significant differences between the repair techniques were found for pain , sensory disturbances or recurrences .", "overall , the hernia recurrence rate was @ % .", "in total @ patients ( @ % ) reported long-term pain of which one-fourth graded this moderate to severe .", "pain was experienced at least weekly by @ patients ( @ % ) and limiting daily activities for @ patients ( @ % ) .", "with regard to the previously reported pain at @ and @ months follow-up , @ patients ( @ % ) experience no pain at all .", "for @ patients ( @ % ) , initial pain disappeared .", "@ patients ( @ % ) suffered persisting pain at all three measure moments .", "@ patients ( @ % ) reported pain at @ years follow-up after an initial pain-free period .", "long-term outcome after randomizing phs , mpr and l showed no clinically relevant differences in chronic pain and its consequences .", "although chronic pain is diminishing over time it remains a serious complication and has sometimes an onset long after the inguinal repair ." ]
to assess long-term superiority in terms of chronic pain between prolene hernia system ( phs ) , mesh plug repair ( mpr ) and lichtenstein ( l ) technique for inguinal hernia repair . eight years after randomizing three commonly used techniques for primary inguinal hernia repair , the outcome was evaluated with a questionnaire measuring pain on verbal descriptor and visual analogue scales , including limitations on daily life activities , sensory disturbances and recurrences . from previous results patients characteristics , operative details and short - and mid-term pain outcome were extracted . @ out of @ eligible patients ( @ % ) completed the follow-up after median @ years ( range @-@ @ ) after the inguinal hernia operation . no significant differences between the repair techniques were found for pain , sensory disturbances or recurrences . overall , the hernia recurrence rate was @ % . in total @ patients ( @ % ) reported long-term pain of which one-fourth graded this moderate to severe . pain was experienced at least weekly by @ patients ( @ % ) and limiting daily activities for @ patients ( @ % ) . with regard to the previously reported pain at @ and @ months follow-up , @ patients ( @ % ) experience no pain at all . for @ patients ( @ % ) , initial pain disappeared . @ patients ( @ % ) suffered persisting pain at all three measure moments . @ patients ( @ % ) reported pain at @ years follow-up after an initial pain-free period . long-term outcome after randomizing phs , mpr and l showed no clinically relevant differences in chronic pain and its consequences . although chronic pain is diminishing over time it remains a serious complication and has sometimes an onset long after the inguinal repair .
25,119,563
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "previous work has demonstrated paradoxical increases in cerebral oxygen saturation ( sco@ ) as blood pressure decreases and paradoxical decreases in sco@ as blood pressure increases .", "it has been suggested that these paradoxical responses indicate a functional cerebral autoregulation mechanism .", "accordingly , the authors hypothesized that if this suggestion is correct , paradoxical responses will occur exclusively in patients with intact cerebral autoregulation .", "thirty-four patients undergoing elective cardiac surgery were included .", "cerebral autoregulation was assessed with the near-infrared spectroscopy-derived cerebral oximetry index ( cox ) , computed by calculating the spearman correlation coefficient between mean arterial pressure and sco@ .", "cox less than @ was previously defined as functional autoregulation .", "during cardiopulmonary bypass , @ % change in blood pressure was accomplished with the use of nitroprusside for decreasing pressure and phenylephrine for increasing pressure .", "effects on cox were assessed .", "data were analyzed using two-way anova , kruskal-wallis test , and wilcoxon and mann-whitney u test .", "sixty-five percent of patients had a baseline cox less than @ , indicating functional baseline autoregulation .", "in @ % of these patients ( n = @ ) , cox became highly negative after vasoactive drug administration ( from -@ -lsb- -@ to @ -rsb- to -@ -lsb- -@ to -@ -rsb- after administration of phenylephrine , and from -@ -lsb- -@ to @ -rsb- to -@ -lsb- -@ to -@ -rsb- after administration of nitroprusside ) .", "a negative cox implies a decrease in sco@ with increase in pressure and , conversely , an increase in sco@ with decrease in pressure .", "in this study , paradoxical changes in sco@ after pharmacological-induced pressure changes occurred exclusively in patients with intact cerebral autoregulation , corroborating the hypothesis that these paradoxical responses might be attributable to a functional cerebral autoregulation ." ]
previous work has demonstrated paradoxical increases in cerebral oxygen saturation ( sco@ ) as blood pressure decreases and paradoxical decreases in sco@ as blood pressure increases . it has been suggested that these paradoxical responses indicate a functional cerebral autoregulation mechanism . accordingly , the authors hypothesized that if this suggestion is correct , paradoxical responses will occur exclusively in patients with intact cerebral autoregulation . thirty-four patients undergoing elective cardiac surgery were included . cerebral autoregulation was assessed with the near-infrared spectroscopy-derived cerebral oximetry index ( cox ) , computed by calculating the spearman correlation coefficient between mean arterial pressure and sco@ . cox less than @ was previously defined as functional autoregulation . during cardiopulmonary bypass , @ % change in blood pressure was accomplished with the use of nitroprusside for decreasing pressure and phenylephrine for increasing pressure . effects on cox were assessed . data were analyzed using two-way anova , kruskal-wallis test , and wilcoxon and mann-whitney u test . sixty-five percent of patients had a baseline cox less than @ , indicating functional baseline autoregulation . in @ % of these patients ( n = @ ) , cox became highly negative after vasoactive drug administration ( from -@ -lsb- -@ to @ -rsb- to -@ -lsb- -@ to -@ -rsb- after administration of phenylephrine , and from -@ -lsb- -@ to @ -rsb- to -@ -lsb- -@ to -@ -rsb- after administration of nitroprusside ) . a negative cox implies a decrease in sco@ with increase in pressure and , conversely , an increase in sco@ with decrease in pressure . in this study , paradoxical changes in sco@ after pharmacological-induced pressure changes occurred exclusively in patients with intact cerebral autoregulation , corroborating the hypothesis that these paradoxical responses might be attributable to a functional cerebral autoregulation .
26,035,251
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "in many facilities , drains are routinely inserted after thyroidectomy with the aim of preventing hematoma formation and accumulation of seroma .", "the continued use of drains may be based more on tradition rather than proven scientific evidence .", "to assess the benefit of drain use after thyroidectomy by determining ; length of hospital stay , post operative pain and wound sepsis .", "this was a randomized controlled trial , carried out at a tertiary national referral hospital ( mulago , kampala ) .", "over a @ month period in @ , we recruited @ patients .", "socio-demographic information and clinical parameters were recorded .", "outcomes measures were evaluated .", "data were double entered into epidata version @ and analyzed using stata version @ .", "ethical approval was secured .", "mean age of participants was @ and @ years in drain and no drain arm respectively .", "most participants were female .", "mean duration of hospital stay after thyroidectomy was significantly higher among the drain arm as compared with the no drain arm -lsb- @ ( @ ) vs @ ( @ ) days ( p = @ ) -rsb- .", "one patient ( drain arm ) had wound infection .", "the pain score on the postoperative day was statistically higher among in the drain arm than the no drain arm -lsb- @ vs @ ( p = @ ) -rsb- .", "not inserting a drain post operatively after thyroid surgery was associated with short hospital stay and less operative pain .", "results of this study do not support routine drainage after thyroid surgery ." ]
in many facilities , drains are routinely inserted after thyroidectomy with the aim of preventing hematoma formation and accumulation of seroma . the continued use of drains may be based more on tradition rather than proven scientific evidence . to assess the benefit of drain use after thyroidectomy by determining ; length of hospital stay , post operative pain and wound sepsis . this was a randomized controlled trial , carried out at a tertiary national referral hospital ( mulago , kampala ) . over a @ month period in @ , we recruited @ patients . socio-demographic information and clinical parameters were recorded . outcomes measures were evaluated . data were double entered into epidata version @ and analyzed using stata version @ . ethical approval was secured . mean age of participants was @ and @ years in drain and no drain arm respectively . most participants were female . mean duration of hospital stay after thyroidectomy was significantly higher among the drain arm as compared with the no drain arm -lsb- @ ( @ ) vs @ ( @ ) days ( p = @ ) -rsb- . one patient ( drain arm ) had wound infection . the pain score on the postoperative day was statistically higher among in the drain arm than the no drain arm -lsb- @ vs @ ( p = @ ) -rsb- . not inserting a drain post operatively after thyroid surgery was associated with short hospital stay and less operative pain . results of this study do not support routine drainage after thyroid surgery .
24,250,317
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "despite precise surgical technique , some postoperative facial scars will depress and widen over time , likely due to weakened or inadequately replaced collagen fibers in the underlying dermis .", "the purpose of this study is to evaluate whether a @,@ nm ablative carbon dioxide ( co@ ) fractional laser used early in the post-surgical setting results in improved postoperative facial scars after a single treatment session .", "a prospective randomized , comparative split-scar study was conducted on @ subjects between the ages of @-@ .", "subjects underwent mohs surgery for nonmelanoma skin cancer of the face .", "subsequent to tumor removal , subjects with a linear scar of @ cm or greater were enrolled .", "on the day of suture removal , all subjects had one-half of their scar randomly selected and treated with a @,@ nm co@ fractional laser ( energy = @ mj ; density = @ % ; spot size = @ mm ; pulse = @ ) .", "the untreated scar half served as a control .", "scars were re-evaluated @ weeks later .", "an independent blinded observer graded the scar halves with the vancouver scar scale ( vss ) immediately prior to treatment and @ weeks after treatment .", "subjects completed a visual analog scale ( vas ) at the same time points .", "three months after laser treatment , a significant decrease in vss and @ of the @ of its individual parameters were detected in both control and treated halves of the scar .", "when comparing the laser group versus the control group , a statistically significant difference was not noted in vss ( p = @ ) but a statistically significant difference in patient vas was detected ( p = @ ) .", "no side effects of the laser treatment were noted .", "facial wounds sutured in a layered manner heal well .", "patients prefer early fractional co@ lasing of surgical scars , though use of the vss failed to detect an objective difference between laser and control halves of scars .", "conservative laser settings , a single session treatment , and vss insensitivity for surgical scars may influence these findings ." ]
despite precise surgical technique , some postoperative facial scars will depress and widen over time , likely due to weakened or inadequately replaced collagen fibers in the underlying dermis . the purpose of this study is to evaluate whether a @,@ nm ablative carbon dioxide ( co@ ) fractional laser used early in the post-surgical setting results in improved postoperative facial scars after a single treatment session . a prospective randomized , comparative split-scar study was conducted on @ subjects between the ages of @-@ . subjects underwent mohs surgery for nonmelanoma skin cancer of the face . subsequent to tumor removal , subjects with a linear scar of @ cm or greater were enrolled . on the day of suture removal , all subjects had one-half of their scar randomly selected and treated with a @,@ nm co@ fractional laser ( energy = @ mj ; density = @ % ; spot size = @ mm ; pulse = @ ) . the untreated scar half served as a control . scars were re-evaluated @ weeks later . an independent blinded observer graded the scar halves with the vancouver scar scale ( vss ) immediately prior to treatment and @ weeks after treatment . subjects completed a visual analog scale ( vas ) at the same time points . three months after laser treatment , a significant decrease in vss and @ of the @ of its individual parameters were detected in both control and treated halves of the scar . when comparing the laser group versus the control group , a statistically significant difference was not noted in vss ( p = @ ) but a statistically significant difference in patient vas was detected ( p = @ ) . no side effects of the laser treatment were noted . facial wounds sutured in a layered manner heal well . patients prefer early fractional co@ lasing of surgical scars , though use of the vss failed to detect an objective difference between laser and control halves of scars . conservative laser settings , a single session treatment , and vss insensitivity for surgical scars may influence these findings .
25,559,589
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "web-based learning is becoming an increasingly important instructional tool in nursing education .", "multimedia advancements offer the potential for creating authentic nursing activities for developing nursing competency in clinical practice .", "this study aims to describe the design , development , and evaluation of an interactive multimedia web-based simulation for developing nurses ' competencies in acute nursing care .", "authentic nursing activities were developed in a web-based simulation using a variety of instructional strategies including animation video , multimedia instructional material , virtual patients , and online quizzes .", "a randomized controlled study was conducted on @ registered nurses who were recruited from the general ward units of an acute care tertiary hospital .", "following a baseline evaluation of all participants ' clinical performance in a simulated clinical setting , the experimental group received @ hours of web-based simulation and completed a survey to evaluate their perceptions of the program .", "all participants were re-tested for their clinical performances using a validated tool .", "the clinical performance posttest scores of the experimental group improved significantly ( p < @ ) from the pretest scores after the web-based simulation .", "in addition , compared to the control group , the experimental group had significantly higher clinical performance posttest scores ( p < @ ) after controlling the pretest scores .", "the participants from the experimental group were satisfied with their learning experience and gave positive ratings for the quality of the web-based simulation .", "themes emerging from the comments about the most valuable aspects of the web-based simulation include relevance to practice , instructional strategies , and fostering problem solving .", "engaging in authentic nursing activities using interactive multimedia web-based simulation can enhance nurses ' competencies in acute care .", "web-based simulations provide a promising educational tool in institutions where large groups of nurses need to be trained in acute nursing care and accessibility to repetitive training is essential for achieving long-term retention of clinical competency ." ]
web-based learning is becoming an increasingly important instructional tool in nursing education . multimedia advancements offer the potential for creating authentic nursing activities for developing nursing competency in clinical practice . this study aims to describe the design , development , and evaluation of an interactive multimedia web-based simulation for developing nurses ' competencies in acute nursing care . authentic nursing activities were developed in a web-based simulation using a variety of instructional strategies including animation video , multimedia instructional material , virtual patients , and online quizzes . a randomized controlled study was conducted on @ registered nurses who were recruited from the general ward units of an acute care tertiary hospital . following a baseline evaluation of all participants ' clinical performance in a simulated clinical setting , the experimental group received @ hours of web-based simulation and completed a survey to evaluate their perceptions of the program . all participants were re-tested for their clinical performances using a validated tool . the clinical performance posttest scores of the experimental group improved significantly ( p < @ ) from the pretest scores after the web-based simulation . in addition , compared to the control group , the experimental group had significantly higher clinical performance posttest scores ( p < @ ) after controlling the pretest scores . the participants from the experimental group were satisfied with their learning experience and gave positive ratings for the quality of the web-based simulation . themes emerging from the comments about the most valuable aspects of the web-based simulation include relevance to practice , instructional strategies , and fostering problem solving . engaging in authentic nursing activities using interactive multimedia web-based simulation can enhance nurses ' competencies in acute care . web-based simulations provide a promising educational tool in institutions where large groups of nurses need to be trained in acute nursing care and accessibility to repetitive training is essential for achieving long-term retention of clinical competency .
25,583,029
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "although obstructive sleep apnea ( osa ) is associated with impaired glucose tolerance and diabetes , it remains unclear whether osa treatment with continuous positive airway pressure ( cpap ) has metabolic benefits .", "to determine the effect of @-hour nightly cpap treatment on glucose metabolism in individuals with prediabetes and osa .", "in a randomized controlled parallel group study , @ participants were randomly assigned to receive either @-hour nightly cpap ( n = @ ) or oral placebo ( n = @ ) .", "sleep was polysomnographically recorded in the laboratory on each night .", "cpap adherence was ensured by continuous supervision .", "participants continued their daily routine activities outside the laboratory .", "glucose metabolism was assessed at baseline and after @ weeks of assigned treatment using both the oral and intravenous glucose tolerance tests .", "the primary outcome was the overall glucose response as quantified by the area under the curve for glucose during @-hour oral glucose tolerance testing .", "secondary outcomes included fasting and @-hour glucose and insulin , the area under the curves for insulin and insulin secretion , norepinephrine , insulin sensitivity , acute insulin response to glucose , and @-hour blood pressure .", "the overall glucose response was reduced ( treatment difference : -@,@ -lsb- mg/dl -rsb- min -lsb- @ % confidence interval , -@,@ to -@ -rsb- ; p = @ ) and insulin sensitivity was improved ( treatment difference : @ -lsb- mu/l -rsb- ( -@ ) min ( -@ ) -lsb- @ % confidence interval , @-@ @ -rsb- ; p = @ ) with cpap as compared with placebo .", "additionally , norepinephrine levels and @-hour blood pressure were reduced with cpap as compared with placebo .", "in patients with prediabetes , @-hour nightly cpap treatment for @ weeks improves glucose metabolism compared with placebo .", "thus , cpap treatment may be beneficial for metabolic risk reduction .", "clinical trial registered with www.clinicaltrials.gov ( nct @ ) ." ]
although obstructive sleep apnea ( osa ) is associated with impaired glucose tolerance and diabetes , it remains unclear whether osa treatment with continuous positive airway pressure ( cpap ) has metabolic benefits . to determine the effect of @-hour nightly cpap treatment on glucose metabolism in individuals with prediabetes and osa . in a randomized controlled parallel group study , @ participants were randomly assigned to receive either @-hour nightly cpap ( n = @ ) or oral placebo ( n = @ ) . sleep was polysomnographically recorded in the laboratory on each night . cpap adherence was ensured by continuous supervision . participants continued their daily routine activities outside the laboratory . glucose metabolism was assessed at baseline and after @ weeks of assigned treatment using both the oral and intravenous glucose tolerance tests . the primary outcome was the overall glucose response as quantified by the area under the curve for glucose during @-hour oral glucose tolerance testing . secondary outcomes included fasting and @-hour glucose and insulin , the area under the curves for insulin and insulin secretion , norepinephrine , insulin sensitivity , acute insulin response to glucose , and @-hour blood pressure . the overall glucose response was reduced ( treatment difference : -@,@ -lsb- mg/dl -rsb- min -lsb- @ % confidence interval , -@,@ to -@ -rsb- ; p = @ ) and insulin sensitivity was improved ( treatment difference : @ -lsb- mu/l -rsb- ( -@ ) min ( -@ ) -lsb- @ % confidence interval , @-@ @ -rsb- ; p = @ ) with cpap as compared with placebo . additionally , norepinephrine levels and @-hour blood pressure were reduced with cpap as compared with placebo . in patients with prediabetes , @-hour nightly cpap treatment for @ weeks improves glucose metabolism compared with placebo . thus , cpap treatment may be beneficial for metabolic risk reduction . clinical trial registered with www.clinicaltrials.gov ( nct @ ) .
25,897,569
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "atrial fibrillation ( af ) is an important independent risk factor for stroke and oral anticoagulation therapy provides a highly effective treatment to reduce this risk .", "active screening strategies improve detection of af in comparison with routine care ; however , whether screen-detected patients have stroke risk profiles favouring anticoagulation is unclear .", "using data derived from the screening for af in the elderly ( safe ) study , the aim of this article was to determine if patients with af detected via active screening have stroke risk profiles that warrant prophylactic anticoagulation .", "secondary analysis of data derived from @ general practices within which cohorts of @ patients were randomly allocated to opportunistic -lsb- pulse and electrocardiogram ( ecg ) -rsb- or systematic screening ( postal invitation for ecg ) .", "stroke risk assessment was undertaken using baseline data extracted from medical records and chads@ criteria .", "chads@ scores were compared between the screening groups .", "one hundred and forty-nine new cases of af were detected , @ via opportunistic screening and @ via systematic screening .", "chads@ scores were @ in @ % -lsb- @ % confidence interval ( ci ) @-@ @ -rsb- of patients detected via opportunistic screening and @ % ( @ % ci @-@ @ ) detected via systematic screening .", "there were no significant differences in stroke risk profiles of patients detected via opportunistic and systematic screenings .", "stroke risk profiles of patients detected via opportunistic and systematic screenings were similar .", "data derived from the safe study suggest that active screening for af in patients aged @ years in primary care is a useful screening programme with @-@ % of patients identified eligible for anticoagulation treatment according to the chads@ criteria ." ]
atrial fibrillation ( af ) is an important independent risk factor for stroke and oral anticoagulation therapy provides a highly effective treatment to reduce this risk . active screening strategies improve detection of af in comparison with routine care ; however , whether screen-detected patients have stroke risk profiles favouring anticoagulation is unclear . using data derived from the screening for af in the elderly ( safe ) study , the aim of this article was to determine if patients with af detected via active screening have stroke risk profiles that warrant prophylactic anticoagulation . secondary analysis of data derived from @ general practices within which cohorts of @ patients were randomly allocated to opportunistic -lsb- pulse and electrocardiogram ( ecg ) -rsb- or systematic screening ( postal invitation for ecg ) . stroke risk assessment was undertaken using baseline data extracted from medical records and chads@ criteria . chads@ scores were compared between the screening groups . one hundred and forty-nine new cases of af were detected , @ via opportunistic screening and @ via systematic screening . chads@ scores were @ in @ % -lsb- @ % confidence interval ( ci ) @-@ @ -rsb- of patients detected via opportunistic screening and @ % ( @ % ci @-@ @ ) detected via systematic screening . there were no significant differences in stroke risk profiles of patients detected via opportunistic and systematic screenings . stroke risk profiles of patients detected via opportunistic and systematic screenings were similar . data derived from the safe study suggest that active screening for af in patients aged @ years in primary care is a useful screening programme with @-@ % of patients identified eligible for anticoagulation treatment according to the chads@ criteria .
24,728,774
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "maternal malnutrition and poor gestational weight gain are the most important causes of low birthweight and infant mortality in bangladesh .", "to assess the effect of short-term nutrition education on weight gain in the third trimester of pregnancy , birth outcomes , and breastfeeding .", "three hundred pregnant women participated in this randomized , controlled trial during a @-month intervention period .", "the study was conducted in two antenatal clinics in urban dhaka .", "one group of women was given monthly education sessions during the third trimester of pregnancy to promote consumption of khichuri , while the control group received only routine services from the health facilities .", "birthweight was recorded within @ hours after delivery .", "breastfeeding practices were observed for @ month after delivery .", "in the intervention group , maternal weight gain in the third trimester was @ % higher ( @ vs. @ kg , p = @ ) , mean birthweight was @ % higher ( @ vs. @ kg , p < @ ) , the rate of low birthweight was @ % lower ( @ % vs. @ % ; p < @ ) , and the rate of initiation of breastfeeding within @ hour after birth was @ % higher ( @ % vs. @ % , p < @ ) , in comparison with the control group .", "birthweight was associated with frequency of intake of khichuri ( p < @ ) .", "nutrition education with a focus on promoting consumption of khichuri during the third trimester of pregnancy significantly reduced the rate of low birthweight and increased maternal weight gain ." ]
maternal malnutrition and poor gestational weight gain are the most important causes of low birthweight and infant mortality in bangladesh . to assess the effect of short-term nutrition education on weight gain in the third trimester of pregnancy , birth outcomes , and breastfeeding . three hundred pregnant women participated in this randomized , controlled trial during a @-month intervention period . the study was conducted in two antenatal clinics in urban dhaka . one group of women was given monthly education sessions during the third trimester of pregnancy to promote consumption of khichuri , while the control group received only routine services from the health facilities . birthweight was recorded within @ hours after delivery . breastfeeding practices were observed for @ month after delivery . in the intervention group , maternal weight gain in the third trimester was @ % higher ( @ vs. @ kg , p = @ ) , mean birthweight was @ % higher ( @ vs. @ kg , p < @ ) , the rate of low birthweight was @ % lower ( @ % vs. @ % ; p < @ ) , and the rate of initiation of breastfeeding within @ hour after birth was @ % higher ( @ % vs. @ % , p < @ ) , in comparison with the control group . birthweight was associated with frequency of intake of khichuri ( p < @ ) . nutrition education with a focus on promoting consumption of khichuri during the third trimester of pregnancy significantly reduced the rate of low birthweight and increased maternal weight gain .
25,639,126
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "premenopausal women diagnosed with breast cancer are at risk for psychological and behavioral disturbances after cancer treatment .", "targeted interventions are needed to address the needs of this vulnerable group .", "this randomized trial provided the first evaluation of a brief , mindfulness-based intervention for younger breast cancer survivors designed to reduce stress , depression , and inflammatory activity .", "women diagnosed with early stage breast cancer at or before age @ who had completed cancer treatment were randomly assigned to a @-week mindful awareness practices ( maps ) intervention group ( n = @ ) or to a wait-list control group ( n = @ ) .", "participants completed questionnaires before and after the intervention to assess stress and depressive symptoms ( primary outcomes ) as well as physical symptoms , cancer-related distress , and positive outcomes .", "blood samples were collected to examine genomic and circulating markers of inflammation .", "participants also completed questionnaires at a @-month follow-up assessment .", "in linear mixed models , the maps intervention led to significant reductions in perceived stress ( p = @ ) and marginal reductions in depressive symptoms ( p = @ ) , as well as significant reductions in proinflammatory gene expression ( p = @ ) and inflammatory signaling ( p = @ ) at postintervention .", "improvements in secondary outcomes included reduced fatigue , sleep disturbance , and vasomotor symptoms and increased peace and meaning and positive affect ( p < @ for all ) .", "intervention effects on psychological and behavioral measures were not maintained at the @-month follow-up assessment , although reductions in cancer-related distress were observed at that assessment .", "a brief , mindfulness-based intervention demonstrated preliminary short-term efficacy in reducing stress , behavioral symptoms , and proinflammatory signaling in younger breast cancer survivors ." ]
premenopausal women diagnosed with breast cancer are at risk for psychological and behavioral disturbances after cancer treatment . targeted interventions are needed to address the needs of this vulnerable group . this randomized trial provided the first evaluation of a brief , mindfulness-based intervention for younger breast cancer survivors designed to reduce stress , depression , and inflammatory activity . women diagnosed with early stage breast cancer at or before age @ who had completed cancer treatment were randomly assigned to a @-week mindful awareness practices ( maps ) intervention group ( n = @ ) or to a wait-list control group ( n = @ ) . participants completed questionnaires before and after the intervention to assess stress and depressive symptoms ( primary outcomes ) as well as physical symptoms , cancer-related distress , and positive outcomes . blood samples were collected to examine genomic and circulating markers of inflammation . participants also completed questionnaires at a @-month follow-up assessment . in linear mixed models , the maps intervention led to significant reductions in perceived stress ( p = @ ) and marginal reductions in depressive symptoms ( p = @ ) , as well as significant reductions in proinflammatory gene expression ( p = @ ) and inflammatory signaling ( p = @ ) at postintervention . improvements in secondary outcomes included reduced fatigue , sleep disturbance , and vasomotor symptoms and increased peace and meaning and positive affect ( p < @ for all ) . intervention effects on psychological and behavioral measures were not maintained at the @-month follow-up assessment , although reductions in cancer-related distress were observed at that assessment . a brief , mindfulness-based intervention demonstrated preliminary short-term efficacy in reducing stress , behavioral symptoms , and proinflammatory signaling in younger breast cancer survivors .
25,537,522
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "in patients with metastatic breast cancer that is positive for human epidermal growth factor receptor @ ( her@ ) , progression-free survival was significantly improved after first-line therapy with pertuzumab , trastuzumab , and docetaxel , as compared with placebo , trastuzumab , and docetaxel .", "overall survival was significantly improved with pertuzumab in an interim analysis without the median being reached .", "we report final prespecified overall survival results with a median follow-up of @ months .", "we randomly assigned patients with metastatic breast cancer who had not received previous chemotherapy or anti-her@ therapy for their metastatic disease to receive the pertuzumab combination or the placebo combination .", "the secondary end points of overall survival , investigator-assessed progression-free survival , independently assessed duration of response , and safety are reported .", "sensitivity analyses were adjusted for patients who crossed over from placebo to pertuzumab after the interim analysis .", "the median overall survival was @ months ( @ % confidence interval -lsb- ci -rsb- , @ to not reached ) in the group receiving the pertuzumab combination , as compared with @ months ( @ % ci , @ to @ ) in the group receiving the placebo combination ( hazard ratio favoring the pertuzumab group , @ ; @ % ci , @ to @ ; p < @ ) , a difference of @ months .", "this analysis was not adjusted for crossover to the pertuzumab group and is therefore conservative .", "results of sensitivity analyses after adjustment for crossover were consistent .", "median progression-free survival as assessed by investigators improved by @ months in the pertuzumab group ( hazard ratio , @ ; @ % ci , @ to @ ) .", "pertuzumab extended the median duration of response by @ months , as independently assessed .", "most adverse events occurred during the administration of docetaxel in the two groups , with long-term cardiac safety maintained .", "in patients with her@-positive metastatic breast cancer , the addition of pertuzumab to trastuzumab and docetaxel , as compared with the addition of placebo , significantly improved the median overall survival to @ months and extended the results of previous analyses showing the efficacy of this drug combination .", "( funded by f. hoffmann-la roche and genentech ; cleopatra clinicaltrials.gov number , nct@ . )" ]
in patients with metastatic breast cancer that is positive for human epidermal growth factor receptor @ ( her@ ) , progression-free survival was significantly improved after first-line therapy with pertuzumab , trastuzumab , and docetaxel , as compared with placebo , trastuzumab , and docetaxel . overall survival was significantly improved with pertuzumab in an interim analysis without the median being reached . we report final prespecified overall survival results with a median follow-up of @ months . we randomly assigned patients with metastatic breast cancer who had not received previous chemotherapy or anti-her@ therapy for their metastatic disease to receive the pertuzumab combination or the placebo combination . the secondary end points of overall survival , investigator-assessed progression-free survival , independently assessed duration of response , and safety are reported . sensitivity analyses were adjusted for patients who crossed over from placebo to pertuzumab after the interim analysis . the median overall survival was @ months ( @ % confidence interval -lsb- ci -rsb- , @ to not reached ) in the group receiving the pertuzumab combination , as compared with @ months ( @ % ci , @ to @ ) in the group receiving the placebo combination ( hazard ratio favoring the pertuzumab group , @ ; @ % ci , @ to @ ; p < @ ) , a difference of @ months . this analysis was not adjusted for crossover to the pertuzumab group and is therefore conservative . results of sensitivity analyses after adjustment for crossover were consistent . median progression-free survival as assessed by investigators improved by @ months in the pertuzumab group ( hazard ratio , @ ; @ % ci , @ to @ ) . pertuzumab extended the median duration of response by @ months , as independently assessed . most adverse events occurred during the administration of docetaxel in the two groups , with long-term cardiac safety maintained . in patients with her@-positive metastatic breast cancer , the addition of pertuzumab to trastuzumab and docetaxel , as compared with the addition of placebo , significantly improved the median overall survival to @ months and extended the results of previous analyses showing the efficacy of this drug combination . ( funded by f. hoffmann-la roche and genentech ; cleopatra clinicaltrials.gov number , nct@ . )
25,693,012
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "sugar overconsumption and chronic stress are growing health concerns because they both may increase the risk for obesity and its related diseases .", "rodent studies suggest that sugar consumption may activate a glucocorticoid-metabolic-brain-negative feedback pathway , which may turn off the stress response and thereby reinforce habitual sugar overconsumption .", "the objective of the study was to test our hypothesized glucocorticoid-metabolic-brain model in women consuming beverages sweetened with either aspartame of sucrose .", "this was a parallel-arm , double-masked diet intervention study .", "the study was conducted at the university of california , davis , clinical and translational science center 's clinical research center and the university of california , davis , medical center imaging research center .", "nineteen women ( age range @-@ y ) with a body mass index ( range @-@ kg/m ( @ ) ) who were a subgroup from a national institutes of health-funded investigation of @ participants assigned to eight experimental groups .", "the intervention consisted of sucrose - or aspartame-sweetened beverage consumption three times per day for @ weeks .", "salivary cortisol and regional brain responses to the montreal imaging stress task were measured .", "compared with aspartame , sucrose consumption was associated with significantly higher activity in the left hippocampus ( p = @ ) .", "sucrose , but not aspartame , consumption associated with reduced ( p = @ ) stress-induced cortisol .", "the sucrose group also had a lower reactivity to naltrexone , significantly ( p = @ ) lower nausea , and a trend ( p = @ ) toward lower cortisol .", "these experimental findings support a metabolic-brain-negative feedback pathway that is affected by sugar and may make some people under stress more hooked on sugar and possibly more vulnerable to obesity and its related conditions ." ]
sugar overconsumption and chronic stress are growing health concerns because they both may increase the risk for obesity and its related diseases . rodent studies suggest that sugar consumption may activate a glucocorticoid-metabolic-brain-negative feedback pathway , which may turn off the stress response and thereby reinforce habitual sugar overconsumption . the objective of the study was to test our hypothesized glucocorticoid-metabolic-brain model in women consuming beverages sweetened with either aspartame of sucrose . this was a parallel-arm , double-masked diet intervention study . the study was conducted at the university of california , davis , clinical and translational science center 's clinical research center and the university of california , davis , medical center imaging research center . nineteen women ( age range @-@ y ) with a body mass index ( range @-@ kg/m ( @ ) ) who were a subgroup from a national institutes of health-funded investigation of @ participants assigned to eight experimental groups . the intervention consisted of sucrose - or aspartame-sweetened beverage consumption three times per day for @ weeks . salivary cortisol and regional brain responses to the montreal imaging stress task were measured . compared with aspartame , sucrose consumption was associated with significantly higher activity in the left hippocampus ( p = @ ) . sucrose , but not aspartame , consumption associated with reduced ( p = @ ) stress-induced cortisol . the sucrose group also had a lower reactivity to naltrexone , significantly ( p = @ ) lower nausea , and a trend ( p = @ ) toward lower cortisol . these experimental findings support a metabolic-brain-negative feedback pathway that is affected by sugar and may make some people under stress more hooked on sugar and possibly more vulnerable to obesity and its related conditions .
25,879,513
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to compare the clinical outcomes of wavefront-guided and wavefront-optimized laser in situ keratomileusis ( lasik ) .", "prospective , randomized , fellow-eye-controlled study .", "the setting was a single academic institution .", "the study population included @ eyes of @ patients with myopia with and without astigmatism .", "one eye of each patient was randomized to undergo wavefront-guided lasik by the amo visx customvue s@ ir excimer laser system ; the fellow eye received wavefront-optimized lasik by the alcon allegretto wave eye-q @ hz excimer laser system .", "corneal flaps were constructed using the intralase fs @ hz femtosecond laser .", "patients were followed at postoperative months @ , @ , @ , and @ .", "the study 's main outcome measures were uncorrected visual acuity , stability of refractive correction , contrast sensitivity , and wavefront aberrometry .", "after @ months , lasik eyes had achieved visual acuity of @/@ @ or better ( @ eyes , @ % ) in the wavefront-guided group compared to those receiving wavefront-optimized treatment ( @ eyes , @ % ) ( p = @ ) .", "average spherical equivalent refractions were -@ @ diopters in wavefront-guided eyes whereas in wavefront-optimized eyes the refractions were -@ @ diopters at @ months .", "wavefront-guided eyes also achieved better best-corrected visual acuity at both the @ % and @ % contrast levels ( p = @ and p = @ , respectively ) .", "there were no differences in levels of residual astigmatism ( p = @ ) or in higher order aberrations ( p = @ ) .", "both wavefront-guided and wavefront-optimized treatments are able to correct myopia safely and effectively in eyes with and without astigmatism .", "however , wavefront-guided treatment platforms appear to offer significant advantages in terms of residual refractive error , uncorrected distance acuity and contrast sensitivity ." ]
to compare the clinical outcomes of wavefront-guided and wavefront-optimized laser in situ keratomileusis ( lasik ) . prospective , randomized , fellow-eye-controlled study . the setting was a single academic institution . the study population included @ eyes of @ patients with myopia with and without astigmatism . one eye of each patient was randomized to undergo wavefront-guided lasik by the amo visx customvue s@ ir excimer laser system ; the fellow eye received wavefront-optimized lasik by the alcon allegretto wave eye-q @ hz excimer laser system . corneal flaps were constructed using the intralase fs @ hz femtosecond laser . patients were followed at postoperative months @ , @ , @ , and @ . the study 's main outcome measures were uncorrected visual acuity , stability of refractive correction , contrast sensitivity , and wavefront aberrometry . after @ months , lasik eyes had achieved visual acuity of @/@ @ or better ( @ eyes , @ % ) in the wavefront-guided group compared to those receiving wavefront-optimized treatment ( @ eyes , @ % ) ( p = @ ) . average spherical equivalent refractions were -@ @ diopters in wavefront-guided eyes whereas in wavefront-optimized eyes the refractions were -@ @ diopters at @ months . wavefront-guided eyes also achieved better best-corrected visual acuity at both the @ % and @ % contrast levels ( p = @ and p = @ , respectively ) . there were no differences in levels of residual astigmatism ( p = @ ) or in higher order aberrations ( p = @ ) . both wavefront-guided and wavefront-optimized treatments are able to correct myopia safely and effectively in eyes with and without astigmatism . however , wavefront-guided treatment platforms appear to offer significant advantages in terms of residual refractive error , uncorrected distance acuity and contrast sensitivity .
24,560,995
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "impairments in mismatch negativity ( mmn ) generation have been consistently reported in patients with schizophrenia .", "however , underlying oscillatory activity of mmn deficits in schizophrenia and the relationship with cognitive impairments have not been investigated in detail .", "time-frequency power and phase analyses can provide more detailed measures of brain dynamics of mmn deficits in schizophrenia .", "@ patients with schizophrenia and @ healthy controls were tested with a roving frequency paradigm to generate mmn .", "time-frequency domain power and phase-locking ( pl ) analysis was performed on all trials using short-time fourier transforms with hanning window tapering .", "a comprehensive battery ( cantab ) was used to assess neurocognitive functioning .", "mean mmn amplitude was significantly lower in patients with schizophrenia ( @ % ci @ - @ ) .", "patients showed significantly lower eeg power ( @ % ci -@ - -@ ) in the ~ @-@ hz frequency range ( theta band ) between @ and @ ms. patients with schizophrenia showed cognitive impairment in multiple domains of cantab .", "however , mmn impairments in amplitude and power were not correlated with clinical measures , medication dose , social functioning or neurocognitive performance .", "the findings from this study suggested that while mmn may be a useful marker to probe nmda receptor mediated mechanisms and associated impairments in gain control and perceptual changes , it may not be a useful marker in association with clinical or cognitive changes .", "trial-by-trial eeg power analysis can be used as a measure of brain dynamics underlying mmn deficits which also can have implications for the use of mmn as a biomarker for drug discovery ." ]
impairments in mismatch negativity ( mmn ) generation have been consistently reported in patients with schizophrenia . however , underlying oscillatory activity of mmn deficits in schizophrenia and the relationship with cognitive impairments have not been investigated in detail . time-frequency power and phase analyses can provide more detailed measures of brain dynamics of mmn deficits in schizophrenia . @ patients with schizophrenia and @ healthy controls were tested with a roving frequency paradigm to generate mmn . time-frequency domain power and phase-locking ( pl ) analysis was performed on all trials using short-time fourier transforms with hanning window tapering . a comprehensive battery ( cantab ) was used to assess neurocognitive functioning . mean mmn amplitude was significantly lower in patients with schizophrenia ( @ % ci @ - @ ) . patients showed significantly lower eeg power ( @ % ci -@ - -@ ) in the ~ @-@ hz frequency range ( theta band ) between @ and @ ms. patients with schizophrenia showed cognitive impairment in multiple domains of cantab . however , mmn impairments in amplitude and power were not correlated with clinical measures , medication dose , social functioning or neurocognitive performance . the findings from this study suggested that while mmn may be a useful marker to probe nmda receptor mediated mechanisms and associated impairments in gain control and perceptual changes , it may not be a useful marker in association with clinical or cognitive changes . trial-by-trial eeg power analysis can be used as a measure of brain dynamics underlying mmn deficits which also can have implications for the use of mmn as a biomarker for drug discovery .
24,358,266
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "despite the availability of new antibiotics such as daptomycin , methicillin-resistant staphylococcus aureus ( mrsa ) bacteraemia continues to be associated with high clinical failure rates .", "combination therapy has been proposed as an alternative to improve outcomes but there is a lack of clinical studies .", "the study aims to demonstrate that combination of daptomycin plus fosfomycin achieves higher clinical success rates in the treatment of mrsa bacteraemia than daptomycin alone .", "a multicentre open-label , randomised phase iii study .", "adult patients hospitalised with mrsa bacteraemia will be randomly assigned ( @:@ ) to group @ : daptomycin @mg/kg/@h intravenous ; or group @ : daptomycin @mg/kg/@h intravenous plus fosfomycin @gr/@g intravenous .", "the main outcome will be treatment response at week @ after stopping therapy ( test-of-cure ( toc ) visit ) .", "this is a composite variable with two values : treatment success : resolution of clinical signs and symptoms ( clinical success ) and negative blood cultures ( microbiological success ) at the toc visit .", "treatment failure : if any of the following conditions apply : ( @ ) lack of clinical improvement at @h or more after starting therapy ; ( @ ) persistent bacteraemia ( positive blood cultures on day @ ) ; ( @ ) therapy is discontinued early due to adverse effects or for some other reason based on clinical judgement ; ( @ ) relapse of mrsa bacteraemia before the toc visit ; ( @ ) death for any reason before the toc visit .", "assuming a @ % cure rate with daptomycin and a @ % difference in cure rates between the two groups , @ patients will be needed for each group ( :@ , : @ ) .", "statistical analysis will be based on intention to treat , as well as per protocol and safety analysis .", "the protocol was approved by the spanish medicines and healthcare products regulatory agency ( aemps ) .", "the sponsor commits itself to publishing the data in first quartile peer-review journals within @months of the completion of the study .", "nct@ ." ]
despite the availability of new antibiotics such as daptomycin , methicillin-resistant staphylococcus aureus ( mrsa ) bacteraemia continues to be associated with high clinical failure rates . combination therapy has been proposed as an alternative to improve outcomes but there is a lack of clinical studies . the study aims to demonstrate that combination of daptomycin plus fosfomycin achieves higher clinical success rates in the treatment of mrsa bacteraemia than daptomycin alone . a multicentre open-label , randomised phase iii study . adult patients hospitalised with mrsa bacteraemia will be randomly assigned ( @:@ ) to group @ : daptomycin @mg/kg/@h intravenous ; or group @ : daptomycin @mg/kg/@h intravenous plus fosfomycin @gr/@g intravenous . the main outcome will be treatment response at week @ after stopping therapy ( test-of-cure ( toc ) visit ) . this is a composite variable with two values : treatment success : resolution of clinical signs and symptoms ( clinical success ) and negative blood cultures ( microbiological success ) at the toc visit . treatment failure : if any of the following conditions apply : ( @ ) lack of clinical improvement at @h or more after starting therapy ; ( @ ) persistent bacteraemia ( positive blood cultures on day @ ) ; ( @ ) therapy is discontinued early due to adverse effects or for some other reason based on clinical judgement ; ( @ ) relapse of mrsa bacteraemia before the toc visit ; ( @ ) death for any reason before the toc visit . assuming a @ % cure rate with daptomycin and a @ % difference in cure rates between the two groups , @ patients will be needed for each group ( :@ , : @ ) . statistical analysis will be based on intention to treat , as well as per protocol and safety analysis . the protocol was approved by the spanish medicines and healthcare products regulatory agency ( aemps ) . the sponsor commits itself to publishing the data in first quartile peer-review journals within @months of the completion of the study . nct@ .
25,762,232
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "BACKGROUND", "BACKGROUND", "BACKGROUND" ]
[ "exacerbation of graves ' orbitopathy ( go ) after radioiodine ( rai ) therapy has been examined in some populations but has not been fully described in japanese populations .", "the purpose of this study was to clarify the characteristics of go exacerbation after rai therapy and the effectiveness of low-dose prophylactic corticosteroid ( pcs ) .", "this was a prospective randomized study in tokyo , japan .", "between june @ and june @ , @ patients with graves ' disease with either inactive go or no go received rai therapy .", "of these , @ received no pcs ( pcs-off group ) , whereas @ received low-dose pcs ( starting dose , @ mg/day of prednisolone ) for @ weeks ( pcs-on group ) .", "we used magnetic resonance imaging to thoroughly evaluate go before and @ year after rai therapy .", "outcomes of go @ year after rai therapy were determined .", "go exacerbation occurred in @ patients ( @ % ) , and only @ patients ( @ % ) required ophthalmic treatment .", "no significant difference in the frequency of go exacerbation was seen between the groups ( pcs-on group : n = @ -lsb- @ % -rsb- ; pcs-off group : n = @ -lsb- @ % -rsb- ; p = @ ) .", "significant prognostic factors were identified as thyroid-stimulating antibody ( by @ % linear increase : risk ratio , @ ; @ % confidence interval , @-@ @ ; p = @ ) and clinical activity score ( @ vs @ : risk ratio , @ ; @ % confidence interval , @-@ @ ; p = @ ) .", "exacerbation of go after rai therapy in the japanese population appears less common than in other populations .", "low-dose pcs did not produce a significant preventive effect and appeared insufficient .", "patients presenting with risk factors would thus be recommended to receive higher-dose pcs ." ]
exacerbation of graves ' orbitopathy ( go ) after radioiodine ( rai ) therapy has been examined in some populations but has not been fully described in japanese populations . the purpose of this study was to clarify the characteristics of go exacerbation after rai therapy and the effectiveness of low-dose prophylactic corticosteroid ( pcs ) . this was a prospective randomized study in tokyo , japan . between june @ and june @ , @ patients with graves ' disease with either inactive go or no go received rai therapy . of these , @ received no pcs ( pcs-off group ) , whereas @ received low-dose pcs ( starting dose , @ mg/day of prednisolone ) for @ weeks ( pcs-on group ) . we used magnetic resonance imaging to thoroughly evaluate go before and @ year after rai therapy . outcomes of go @ year after rai therapy were determined . go exacerbation occurred in @ patients ( @ % ) , and only @ patients ( @ % ) required ophthalmic treatment . no significant difference in the frequency of go exacerbation was seen between the groups ( pcs-on group : n = @ -lsb- @ % -rsb- ; pcs-off group : n = @ -lsb- @ % -rsb- ; p = @ ) . significant prognostic factors were identified as thyroid-stimulating antibody ( by @ % linear increase : risk ratio , @ ; @ % confidence interval , @-@ @ ; p = @ ) and clinical activity score ( @ vs @ : risk ratio , @ ; @ % confidence interval , @-@ @ ; p = @ ) . exacerbation of go after rai therapy in the japanese population appears less common than in other populations . low-dose pcs did not produce a significant preventive effect and appeared insufficient . patients presenting with risk factors would thus be recommended to receive higher-dose pcs .
25,965,082
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "motives for use have been identified as important predictors of substance use and related problems ; however , little is known about how motives for use change following an intervention and how this change may impact future substance use behaviors .", "the present study sought to describe change in motives following an intervention for marijuana-dependent adults .", "furthermore , investigators examined change in motives as a predictor of treatment outcome .", "the study randomized @ adults to one of two conditions : both of which received @-sessions base treatment of cognitive behavioral therapy and motivational enhancement therapy and had access to additional sessions of cognitive behavioral treatment on an as-needed basis .", "the experimental condition received two additional `` check-ups '' during the course of follow-up .", "significant decreases in reported frequency of motives used were observed following treatment .", "changes in expansion and coping were associated with differential treatment outcomes .", "decreases in expansion were associated with poorer treatment outcome , while decreases in coping were associated with better treatment outcome .", "the relationship between expansion motives and outcomes was paradoxical .", "although there were some inconsistencies in the findings , the results regarding the coping motive were consistent with hypotheses and may have important implications for treatment ." ]
motives for use have been identified as important predictors of substance use and related problems ; however , little is known about how motives for use change following an intervention and how this change may impact future substance use behaviors . the present study sought to describe change in motives following an intervention for marijuana-dependent adults . furthermore , investigators examined change in motives as a predictor of treatment outcome . the study randomized @ adults to one of two conditions : both of which received @-sessions base treatment of cognitive behavioral therapy and motivational enhancement therapy and had access to additional sessions of cognitive behavioral treatment on an as-needed basis . the experimental condition received two additional `` check-ups '' during the course of follow-up . significant decreases in reported frequency of motives used were observed following treatment . changes in expansion and coping were associated with differential treatment outcomes . decreases in expansion were associated with poorer treatment outcome , while decreases in coping were associated with better treatment outcome . the relationship between expansion motives and outcomes was paradoxical . although there were some inconsistencies in the findings , the results regarding the coping motive were consistent with hypotheses and may have important implications for treatment .
24,685,559
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the bile acid derivative @-ethylchenodeoxycholic acid ( obeticholic acid ) is a potent activator of the farnesoid x nuclear receptor that reduces liver fat and fibrosis in animal models of fatty liver disease .", "we assessed the efficacy of obeticholic acid in adult patients with non-alcoholic steatohepatitis .", "we did a multicentre , double-blind , placebo-controlled , parallel group , randomised clinical trial at medical centres in the usa in patients with non-cirrhotic , non-alcoholic steatohepatitis to assess treatment with obeticholic acid given orally ( @ mg daily ) or placebo for @ weeks .", "patients were randomly assigned @:@ using a computer-generated , centrally administered procedure , stratified by clinical centre and diabetes status .", "the primary outcome measure was improvement in centrally scored liver histology defined as a decrease in non-alcoholic fatty liver disease activity score by at least @ points without worsening of fibrosis from baseline to the end of treatment .", "a planned interim analysis of change in alanine aminotransferase at @ weeks undertaken before end-of-treatment ( @ weeks ) biopsies supported the decision to continue the trial ( relative change in alanine aminotransferase -@ % , @ % ci -@ to -@ ) .", "a planned interim analysis of the primary outcome showed improved efficacy of obeticholic acid ( p = @ ) and supported a decision not to do end-of-treatment biopsies and end treatment early in @ patients , but to continue the trial to obtain the @-week post-treatment measures .", "analyses were done by intention-to-treat .", "this trial was registered with clinicaltrials.gov , number nct@ .", "between march @ , @ , and dec @ , @ , @ patients were randomly assigned to receive obeticholic acid and @ to placebo .", "@ ( @ % ) of @ patients in the obeticholic acid group who were meant to have biopsies at baseline and @ weeks had improved liver histology compared with @ ( @ % ) of @ such patients in the placebo group ( relative risk @ , @ % ci @ to @ ; p = @ ) .", "@ ( @ % ) of @ patients in the obeticholic acid developed pruritus compared with nine ( @ % ) of @ in the placebo group .", "obeticholic acid improved the histological features of non-alcoholic steatohepatitis , but its long-term benefits and safety need further clarification .", "national institute of diabetes and digestive and kidney diseases , intercept pharmaceuticals ." ]
the bile acid derivative @-ethylchenodeoxycholic acid ( obeticholic acid ) is a potent activator of the farnesoid x nuclear receptor that reduces liver fat and fibrosis in animal models of fatty liver disease . we assessed the efficacy of obeticholic acid in adult patients with non-alcoholic steatohepatitis . we did a multicentre , double-blind , placebo-controlled , parallel group , randomised clinical trial at medical centres in the usa in patients with non-cirrhotic , non-alcoholic steatohepatitis to assess treatment with obeticholic acid given orally ( @ mg daily ) or placebo for @ weeks . patients were randomly assigned @:@ using a computer-generated , centrally administered procedure , stratified by clinical centre and diabetes status . the primary outcome measure was improvement in centrally scored liver histology defined as a decrease in non-alcoholic fatty liver disease activity score by at least @ points without worsening of fibrosis from baseline to the end of treatment . a planned interim analysis of change in alanine aminotransferase at @ weeks undertaken before end-of-treatment ( @ weeks ) biopsies supported the decision to continue the trial ( relative change in alanine aminotransferase -@ % , @ % ci -@ to -@ ) . a planned interim analysis of the primary outcome showed improved efficacy of obeticholic acid ( p = @ ) and supported a decision not to do end-of-treatment biopsies and end treatment early in @ patients , but to continue the trial to obtain the @-week post-treatment measures . analyses were done by intention-to-treat . this trial was registered with clinicaltrials.gov , number nct@ . between march @ , @ , and dec @ , @ , @ patients were randomly assigned to receive obeticholic acid and @ to placebo . @ ( @ % ) of @ patients in the obeticholic acid group who were meant to have biopsies at baseline and @ weeks had improved liver histology compared with @ ( @ % ) of @ such patients in the placebo group ( relative risk @ , @ % ci @ to @ ; p = @ ) . @ ( @ % ) of @ patients in the obeticholic acid developed pruritus compared with nine ( @ % ) of @ in the placebo group . obeticholic acid improved the histological features of non-alcoholic steatohepatitis , but its long-term benefits and safety need further clarification . national institute of diabetes and digestive and kidney diseases , intercept pharmaceuticals .
25,468,160
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]
[ "strategies are needed to help general practitioners ( gps ) promote smoking cessation as recommended by guidelines .", "this study examines whether the quality of action planning among gps improves their provision of smoking cessation care .", "the effectiveness of a @-h training programme was examined in a cluster randomised controlled trial in which @ gps participated .", "gps who followed the training ( intervention group ; n = @ ) formulated action plans related to i ) enquiring about smoking , ii ) advising to quit smoking , and iii ) arranging follow-up for smokers motivated to quit .", "gps also formulated a coping plan for encountering smokers not motivated to quit .", "the quality of these plans ( plan specificity ) was rated and , @ weeks after the training , gps reported on the performance of these plans ( plan enactment ) .", "multilevel regression analyses were used to examine the effects of plan specificity and plan enactment on patient-reported smoking cessation activities of the gps in the intervention group ( n = @,@ patients ) compared with the control group ( n = @,@ patients ) .", "compared to the control group , gps who formulated a highly specific action plan during the training asked their patients about smoking more often after the training compared to prior to the training ( or @ , @ % ci @-@ @ ) .", "gps were most likely to have asked patients about smoking after the training compared to prior to the training when they had enacted a highly specific formulated action plan ( or @ , @ % ci @-@ @ ) .", "the effects of gp plan specificity and plan enactment on asking patient about smoking were most prominent among gps who , at baseline , intended to provide smoking cessation care .", "a highly specific action plan formulated by a gp on when , how , and by whom patients will be asked about smoking had a positive effect on gps ' asking patients about smoking , especially when these professionals also reported to have enacted this plan .", "this effect was most prominent among gps who intended to provide smoking cessation care prior to the intervention .", "training in devising personalised coping plans is recommended to further increase gps ' provision of advice to quit smoking and arranging follow-up support to quit smoking ." ]
strategies are needed to help general practitioners ( gps ) promote smoking cessation as recommended by guidelines . this study examines whether the quality of action planning among gps improves their provision of smoking cessation care . the effectiveness of a @-h training programme was examined in a cluster randomised controlled trial in which @ gps participated . gps who followed the training ( intervention group ; n = @ ) formulated action plans related to i ) enquiring about smoking , ii ) advising to quit smoking , and iii ) arranging follow-up for smokers motivated to quit . gps also formulated a coping plan for encountering smokers not motivated to quit . the quality of these plans ( plan specificity ) was rated and , @ weeks after the training , gps reported on the performance of these plans ( plan enactment ) . multilevel regression analyses were used to examine the effects of plan specificity and plan enactment on patient-reported smoking cessation activities of the gps in the intervention group ( n = @,@ patients ) compared with the control group ( n = @,@ patients ) . compared to the control group , gps who formulated a highly specific action plan during the training asked their patients about smoking more often after the training compared to prior to the training ( or @ , @ % ci @-@ @ ) . gps were most likely to have asked patients about smoking after the training compared to prior to the training when they had enacted a highly specific formulated action plan ( or @ , @ % ci @-@ @ ) . the effects of gp plan specificity and plan enactment on asking patient about smoking were most prominent among gps who , at baseline , intended to provide smoking cessation care . a highly specific action plan formulated by a gp on when , how , and by whom patients will be asked about smoking had a positive effect on gps ' asking patients about smoking , especially when these professionals also reported to have enacted this plan . this effect was most prominent among gps who intended to provide smoking cessation care prior to the intervention . training in devising personalised coping plans is recommended to further increase gps ' provision of advice to quit smoking and arranging follow-up support to quit smoking .
25,547,978
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the preferred approach to the management of common bile duct ( cbd ) stones is uncertain , with single-stage laparoscopic cholecystectomy and cbd exploration vs. two-stage preoperative endoscopic cbd clearance followed by laparoscopic cholecystectomy being debated .", "to address this , a prospective randomized study which compared these two management strategies was undertaken .", "between jan @ and dec @ , patients with gallstones and common bile duct stones diagnosed by preoperative ultrasonography and magnetic resonance cholangiopancreatography were randomized to single-stage vs. two-stage treatment .", "in a single-stage group , laparoscopic cholecystectomy and cbd exploration were undertaken at the same operation , whereas in a two-stage group , endoscopic stone clearance was followed by laparoscopic cholecystectomy @-@ days later .", "early treatment success and complications and longer-term follow-up for the two groups were compared .", "two hundred twenty-one patients were enrolled in the trial , @ in the single-stage group and @ in the two-stage group .", "there was no significant difference in the success rate of cbd clearance ( @ vs. @ % , p = @ ) or the complication rates ( @ vs. @ % , p = @ ) between the groups .", "however , at longer-term follow-up , recurrent cbd stones were seen more often in the two-stage group ( @ vs. @ % , p = @ ) .", "the single-stage and two-stage approaches were equally effective in achieving initial clearance of cbd stones .", "however , recurrent cbd stones occurred more commonly in patients who had undergone two-stage treatment with initial endoscopic stone clearance , followed by laparoscopic cholecystectomy ." ]
the preferred approach to the management of common bile duct ( cbd ) stones is uncertain , with single-stage laparoscopic cholecystectomy and cbd exploration vs. two-stage preoperative endoscopic cbd clearance followed by laparoscopic cholecystectomy being debated . to address this , a prospective randomized study which compared these two management strategies was undertaken . between jan @ and dec @ , patients with gallstones and common bile duct stones diagnosed by preoperative ultrasonography and magnetic resonance cholangiopancreatography were randomized to single-stage vs. two-stage treatment . in a single-stage group , laparoscopic cholecystectomy and cbd exploration were undertaken at the same operation , whereas in a two-stage group , endoscopic stone clearance was followed by laparoscopic cholecystectomy @-@ days later . early treatment success and complications and longer-term follow-up for the two groups were compared . two hundred twenty-one patients were enrolled in the trial , @ in the single-stage group and @ in the two-stage group . there was no significant difference in the success rate of cbd clearance ( @ vs. @ % , p = @ ) or the complication rates ( @ vs. @ % , p = @ ) between the groups . however , at longer-term follow-up , recurrent cbd stones were seen more often in the two-stage group ( @ vs. @ % , p = @ ) . the single-stage and two-stage approaches were equally effective in achieving initial clearance of cbd stones . however , recurrent cbd stones occurred more commonly in patients who had undergone two-stage treatment with initial endoscopic stone clearance , followed by laparoscopic cholecystectomy .
24,493,296
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "amino-acid ( aa ) metabolic signatures differ in insulin-resistant ( ir ) obese vs normal-weight subjects , improve after weight loss , and seem to predict the risk of type @ diabetes .", "it is unknown whether weight-maintaining dietary measures aimed at influencing ir alter aa signatures of high-risk subjects .", "in the randomized controlled protein , fiber and metabolic syndrome ( profimet ) trial we investigated effects of four isoenergetic , moderately fat-reduced diets varying in protein and cereal-fiber contents on complete aa metabolic signatures in @ group-matched overweight or obese high-risk subjects .", "we analyzed the relation of whole-body and hepatic ir with aa signatures , body fat composition and liver fat , after @ , @ , and @ weeks of dietary intervention .", "discrimination between diets was further enhanced by providing tailored dietary supplements for twice-daily consumption over @ weeks in all groups .", "baseline aa , including branched-chain signatures significantly related to ir , liver fat , and visceral fat mass .", "isoenergetic variation of protein and cereal-fiber dietary contents , but not fat restriction , significantly influenced ir , whereas the relation of aa with ir changed with all diets .", "the tryptophan ratio was significantly suppressed in obese vs overweight participants , but increased after @ weeks of high cereal-fiber intake to a nonobese phenotype .", "modeling analyses revealed diet-induced alterations of complex aa profiles to relate to @ % and @ % of changes in whole-body and hepatic ir .", "we demonstrate that relatively short-term isoenergetic changes in the diet significantly alter the relation of aa signatures with ir , with possible implications on the determination and treatment of diabetes risk ." ]
amino-acid ( aa ) metabolic signatures differ in insulin-resistant ( ir ) obese vs normal-weight subjects , improve after weight loss , and seem to predict the risk of type @ diabetes . it is unknown whether weight-maintaining dietary measures aimed at influencing ir alter aa signatures of high-risk subjects . in the randomized controlled protein , fiber and metabolic syndrome ( profimet ) trial we investigated effects of four isoenergetic , moderately fat-reduced diets varying in protein and cereal-fiber contents on complete aa metabolic signatures in @ group-matched overweight or obese high-risk subjects . we analyzed the relation of whole-body and hepatic ir with aa signatures , body fat composition and liver fat , after @ , @ , and @ weeks of dietary intervention . discrimination between diets was further enhanced by providing tailored dietary supplements for twice-daily consumption over @ weeks in all groups . baseline aa , including branched-chain signatures significantly related to ir , liver fat , and visceral fat mass . isoenergetic variation of protein and cereal-fiber dietary contents , but not fat restriction , significantly influenced ir , whereas the relation of aa with ir changed with all diets . the tryptophan ratio was significantly suppressed in obese vs overweight participants , but increased after @ weeks of high cereal-fiber intake to a nonobese phenotype . modeling analyses revealed diet-induced alterations of complex aa profiles to relate to @ % and @ % of changes in whole-body and hepatic ir . we demonstrate that relatively short-term isoenergetic changes in the diet significantly alter the relation of aa signatures with ir , with possible implications on the determination and treatment of diabetes risk .
25,157,543
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "recently , men with intermediate-risk prostate cancer ( pc ) were classified into favorable and unfavorable categories ; however , whether the risk of pc-specific mortality ( pcsm ) among men with high-risk pc versus unfavorable intermediate-risk pc is increased is unknown .", "in a prospective , randomized trial conducted between @ and @ , @ men with intermediate-risk or high-risk pc were randomized to receive @ gy with or without @ months of androgen-suppression therapy ( ast ) .", "the subgroup of @ patients with information available on the percentage of positive biopsies formed the cohort .", "fine and gray regression analysis was used to assess whether men with high-risk pc versus unfavorable intermediate-risk pc had an increased risk of pcsm .", "after a median follow-up of @ years , there were @ deaths ( @ % ) , including @ deaths ( @ % ) from pc .", "there were no pc deaths in the favorable intermediate-risk group .", "there was an increase in the risk of pcsm among men with high-risk pc versus unfavorable intermediate-risk pc , but the difference was not significant ( adjusted hazard ratio , @ ; @ % confidence interval , @-@ @ ; p = @ ) after adjusting for age , randomized treatment arm , and comorbidity .", "the lack of pc deaths among men with favorable intermediate-risk pc suggests that adding ast may not reduce their risk of pcsm ; whereas many men with unfavorable intermediate-risk pc are at risk for harboring occult pc with gleason scores from @ to @ and , if proven , would benefit from long-term ast .", "multiparametric magnetic resonance imaging and targeted biopsy of suspicious lesions should be considered to identify pc with gleason scores from @ to @ in these men ." ]
recently , men with intermediate-risk prostate cancer ( pc ) were classified into favorable and unfavorable categories ; however , whether the risk of pc-specific mortality ( pcsm ) among men with high-risk pc versus unfavorable intermediate-risk pc is increased is unknown . in a prospective , randomized trial conducted between @ and @ , @ men with intermediate-risk or high-risk pc were randomized to receive @ gy with or without @ months of androgen-suppression therapy ( ast ) . the subgroup of @ patients with information available on the percentage of positive biopsies formed the cohort . fine and gray regression analysis was used to assess whether men with high-risk pc versus unfavorable intermediate-risk pc had an increased risk of pcsm . after a median follow-up of @ years , there were @ deaths ( @ % ) , including @ deaths ( @ % ) from pc . there were no pc deaths in the favorable intermediate-risk group . there was an increase in the risk of pcsm among men with high-risk pc versus unfavorable intermediate-risk pc , but the difference was not significant ( adjusted hazard ratio , @ ; @ % confidence interval , @-@ @ ; p = @ ) after adjusting for age , randomized treatment arm , and comorbidity . the lack of pc deaths among men with favorable intermediate-risk pc suggests that adding ast may not reduce their risk of pcsm ; whereas many men with unfavorable intermediate-risk pc are at risk for harboring occult pc with gleason scores from @ to @ and , if proven , would benefit from long-term ast . multiparametric magnetic resonance imaging and targeted biopsy of suspicious lesions should be considered to identify pc with gleason scores from @ to @ in these men .
24,604,289
[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the purpose of this study was to demonstrate the activity of agmatine , an inducible nitric oxide synthase ( inos ) inhibitor and selective n-methyl-d-aspartate receptor ( nmdar ) antagonist , on reducing tissue damage in distal part of traumatic nerve in an experimental rat peripheral nerve injury model .", "sciatic nerves of @ sprague dawley male rats were used .", "rats were divided into @ groups ; group @ ( n = @ ) , control group ; group @ ( n = @ ) , axonotmesis + placebo group ; group @ ( n = @ ) , axonotmesis + @ mg/kg agmatine treatment group ; group @ ( n = @ ) , neurotmesis + placebo group ; group @ ( n = @ ) , neurotmesis + @ mg/kg agmatine treatment group .", "axonolysis , axon degeneration , edema , hemorrhage , and inflammation were evaluated in histopathologic examinations of all the groups .", "when group @ was compared with group @ in histopathologic sections , axonolysis was less in group @ ( p = @ ) , as was axon degeneration ( p = @ ) and edema ( p = @ ) .", "when group @ was compared with group @ , axonolysis was less in group @ ( p = @ ) , as was axon degeneration ( p = @ ) and edema ( p = @ ) .", "this study demonstrated agmatine to have antioxidant and antineurotoxic effects in an experimental rat peripheral nerve injury model ." ]
the purpose of this study was to demonstrate the activity of agmatine , an inducible nitric oxide synthase ( inos ) inhibitor and selective n-methyl-d-aspartate receptor ( nmdar ) antagonist , on reducing tissue damage in distal part of traumatic nerve in an experimental rat peripheral nerve injury model . sciatic nerves of @ sprague dawley male rats were used . rats were divided into @ groups ; group @ ( n = @ ) , control group ; group @ ( n = @ ) , axonotmesis + placebo group ; group @ ( n = @ ) , axonotmesis + @ mg/kg agmatine treatment group ; group @ ( n = @ ) , neurotmesis + placebo group ; group @ ( n = @ ) , neurotmesis + @ mg/kg agmatine treatment group . axonolysis , axon degeneration , edema , hemorrhage , and inflammation were evaluated in histopathologic examinations of all the groups . when group @ was compared with group @ in histopathologic sections , axonolysis was less in group @ ( p = @ ) , as was axon degeneration ( p = @ ) and edema ( p = @ ) . when group @ was compared with group @ , axonolysis was less in group @ ( p = @ ) , as was axon degeneration ( p = @ ) and edema ( p = @ ) . this study demonstrated agmatine to have antioxidant and antineurotoxic effects in an experimental rat peripheral nerve injury model .
24,831,360
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "health-related quality of life is often collected in clinical studies , and forms a cornerstone of economic evaluation .", "this study had two objectives , firstly to report and compare pre - and post-progression health state utilities in advanced melanoma when valued by different methods and secondly to explore the validity of progression-based health state utility modelling compared to modelling based upon time to death .", "utilities were generated from the ipilimumab mdx@-@ trial ( clinicaltrials.gov identifier : nct@ ) using the condition-specific eortc qlq-c@ ( via the eortc-@d ) and generic sf-@v@ ( via the sf-@d ) preference-based measures .", "analyses by progression status and time to death were conducted on the patient-level data from the mdx@-@ trial using generalised estimating equations fitted in stata , and the predictive abilities of the two approaches compared .", "mean utility showed a decrease on disease progression in both the eortc-@d ( @ to @ ) and the sf-@d ( @ to @ ) .", "whilst higher utilities were obtained using the eortc-@d , the relative decrease in utility on progression was similar between measures .", "when analysed by time to death , both eortc-@d and sf-@d showed a large decrease in utility in the @ days prior to death ( from @ to @ and from @ to @ , respectively ) .", "compared to progression status alone , the use of time to death gave similar or better estimates of the original data when used to predict patient utility in the mdx@-@ study .", "including both progression status and time to death further improved model fit .", "utilities seen in mdx@-@ were also broadly comparable with those seen in the literature .", "patient-level utility data should be analysed prior to constructing economic models , as analysis solely by progression status may not capture all predictive factors of patient utility and time to death may , as death approaches , be as or more important .", "additionally this study adds to the body of evidence showing that different scales lead to different health state values .", "further research is needed on how different utility instruments ( the sf-@d , eortc-@d and eq-@d ) relate to each other in different disease areas ." ]
health-related quality of life is often collected in clinical studies , and forms a cornerstone of economic evaluation . this study had two objectives , firstly to report and compare pre - and post-progression health state utilities in advanced melanoma when valued by different methods and secondly to explore the validity of progression-based health state utility modelling compared to modelling based upon time to death . utilities were generated from the ipilimumab mdx@-@ trial ( clinicaltrials.gov identifier : nct@ ) using the condition-specific eortc qlq-c@ ( via the eortc-@d ) and generic sf-@v@ ( via the sf-@d ) preference-based measures . analyses by progression status and time to death were conducted on the patient-level data from the mdx@-@ trial using generalised estimating equations fitted in stata , and the predictive abilities of the two approaches compared . mean utility showed a decrease on disease progression in both the eortc-@d ( @ to @ ) and the sf-@d ( @ to @ ) . whilst higher utilities were obtained using the eortc-@d , the relative decrease in utility on progression was similar between measures . when analysed by time to death , both eortc-@d and sf-@d showed a large decrease in utility in the @ days prior to death ( from @ to @ and from @ to @ , respectively ) . compared to progression status alone , the use of time to death gave similar or better estimates of the original data when used to predict patient utility in the mdx@-@ study . including both progression status and time to death further improved model fit . utilities seen in mdx@-@ were also broadly comparable with those seen in the literature . patient-level utility data should be analysed prior to constructing economic models , as analysis solely by progression status may not capture all predictive factors of patient utility and time to death may , as death approaches , be as or more important . additionally this study adds to the body of evidence showing that different scales lead to different health state values . further research is needed on how different utility instruments ( the sf-@d , eortc-@d and eq-@d ) relate to each other in different disease areas .
25,214,238
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "recent technological advances in nebulization permit researchers to target specific parts of the lungs by modifying delivery method .", "the aim of this study was to compare the central and peripheral targeted modalities of administration .", "lung and regional deposition of inhaled technetium-@m diethylene triamine penta-acetic was measured by scintigraphy after peripheral and central targeted modalities of administration with an akita device in @ healthy subjects .", "drug targeting nebulization delivered a large amount of drug into the peripheral part of the lung independent of the modality ( outer-to-inner deposition ratio of @ @ vs. @ @ for central and peripheral modalities , respectively ) , but there was no difference in lung deposition ( whole-body deposition , @ @ % vs. @ @ % , p = @ ) or regional deposition ( p = @ ) between both modalities .", "the extrathoracic deposition was < @ % of the whole-body deposition , without a difference between modalities ( p = @ ) .", "this study shows for the first time that choosing @ different specific drug targeting nebulization modes does not influence the amount of drug delivered into the lung in healthy male subjects .", "moreover , the modes do not modify the site of deposition under the conditions of our study ." ]
recent technological advances in nebulization permit researchers to target specific parts of the lungs by modifying delivery method . the aim of this study was to compare the central and peripheral targeted modalities of administration . lung and regional deposition of inhaled technetium-@m diethylene triamine penta-acetic was measured by scintigraphy after peripheral and central targeted modalities of administration with an akita device in @ healthy subjects . drug targeting nebulization delivered a large amount of drug into the peripheral part of the lung independent of the modality ( outer-to-inner deposition ratio of @ @ vs. @ @ for central and peripheral modalities , respectively ) , but there was no difference in lung deposition ( whole-body deposition , @ @ % vs. @ @ % , p = @ ) or regional deposition ( p = @ ) between both modalities . the extrathoracic deposition was < @ % of the whole-body deposition , without a difference between modalities ( p = @ ) . this study shows for the first time that choosing @ different specific drug targeting nebulization modes does not influence the amount of drug delivered into the lung in healthy male subjects . moreover , the modes do not modify the site of deposition under the conditions of our study .
25,161,302
[ "BACKGROUND", "BACKGROUND", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to assess whether an oxygen saturation ( spo@ ) target of @ % -@ % compared with @ % -@ % reduced the incidence of the composite outcome of death or major disability at @ years of age in infants born at < @ weeks ' gestation .", "a total @ infants were randomized to a lower or higher target from < @ hours of age until @ weeks ' gestational age .", "blinding was achieved by targeting a displayed spo@ of @ % -@ % using a saturation monitor offset by @ % within the range @ % -@ % .", "true saturations were displayed outside this range .", "follow-up at @ years ' corrected age was by pediatric examination and formal neurodevelopmental assessment .", "major disability was gross motor disability , cognitive or language delay , severe hearing loss , or blindness .", "the primary outcome was known for @ infants with @ using surrogate language information .", "targeting a lower compared with a higher spo@ target range had no significant effect on the rate of death or major disability at @ years ' corrected age ( @/@ -lsb- @ % -rsb- vs @/@ -lsb- @ % -rsb- ; relative risk @ , @ % ci @-@ @ ) or any secondary outcomes .", "death occurred in @ ( @ % ) and @ ( @ % ) of those randomized to the lower and higher target , respectively , and blindness in @ % and @ % .", "although there was no benefit or harm from targeting a lower compared with a higher saturation in this trial , further information will become available from the prospectively planned meta-analysis of this and @ other trials comprising a total of nearly @ infants ." ]
to assess whether an oxygen saturation ( spo@ ) target of @ % -@ % compared with @ % -@ % reduced the incidence of the composite outcome of death or major disability at @ years of age in infants born at < @ weeks ' gestation . a total @ infants were randomized to a lower or higher target from < @ hours of age until @ weeks ' gestational age . blinding was achieved by targeting a displayed spo@ of @ % -@ % using a saturation monitor offset by @ % within the range @ % -@ % . true saturations were displayed outside this range . follow-up at @ years ' corrected age was by pediatric examination and formal neurodevelopmental assessment . major disability was gross motor disability , cognitive or language delay , severe hearing loss , or blindness . the primary outcome was known for @ infants with @ using surrogate language information . targeting a lower compared with a higher spo@ target range had no significant effect on the rate of death or major disability at @ years ' corrected age ( @/@ -lsb- @ % -rsb- vs @/@ -lsb- @ % -rsb- ; relative risk @ , @ % ci @-@ @ ) or any secondary outcomes . death occurred in @ ( @ % ) and @ ( @ % ) of those randomized to the lower and higher target , respectively , and blindness in @ % and @ % . although there was no benefit or harm from targeting a lower compared with a higher saturation in this trial , further information will become available from the prospectively planned meta-analysis of this and @ other trials comprising a total of nearly @ infants .
24,560,181
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "insulin degludec/insulin aspart ( idegasp ) is the first combination of a basal insulin with an ultralong duration of action , and a rapid-acting insulin in a single injection .", "this trial compared idegasp with biphasic insulin aspart @ ( biasp @ ) in adults with type @ diabetes inadequately controlled with once - or twice-daily ( od or bid ) pre - or self-mixed insulin with or without oral antidiabetic drugs .", "in this @-week , randomized , open-label , multinational , treat-to-target trial , participants ( mean age @ years , duration of diabetes @ years , bmi @ kg/m ( @ ) , and hba@c @ % -lsb- @ mmol/mol -rsb- ) were exposed ( @:@ ) to bid injections of idegasp ( n = @ ) or biasp @ ( n = @ ) , administered with breakfast and the main evening meal and dose titrated to a self-measured premeal plasma glucose ( pg ) target of @-@ @ mmol/l .", "after @ weeks , mean hba@c was @ % ( @ mmol/mol ) for both groups , with idegasp achieving the prespecified noninferiority margin for mean change in hba@c ( estimated treatment difference -lsb- etd -rsb- -@ % points -lsb- @ % ci -@ to @ -rsb- ) .", "treatment with idegasp was superior in lowering fasting pg ( etd -@ mmol/l -lsb- @ % ci -@ to -@ -rsb- , p < @ ) and had a significantly lower final mean daily insulin dose ( estimated rate ratio @ -lsb- @ % ci @-@ @ -rsb- , p = @ ) .", "fewer confirmed , nocturnal confirmed , and severe hypoglycemia episodes were reported for idegasp compared with biasp @ .", "idegasp bid effectively improves hba@c and fasting pg levels with fewer hypoglycemia episodes versus biasp @ in patients with uncontrolled type @ diabetes previously treated with once - or twice-daily pre - or self-mixed insulin ." ]
insulin degludec/insulin aspart ( idegasp ) is the first combination of a basal insulin with an ultralong duration of action , and a rapid-acting insulin in a single injection . this trial compared idegasp with biphasic insulin aspart @ ( biasp @ ) in adults with type @ diabetes inadequately controlled with once - or twice-daily ( od or bid ) pre - or self-mixed insulin with or without oral antidiabetic drugs . in this @-week , randomized , open-label , multinational , treat-to-target trial , participants ( mean age @ years , duration of diabetes @ years , bmi @ kg/m ( @ ) , and hba@c @ % -lsb- @ mmol/mol -rsb- ) were exposed ( @:@ ) to bid injections of idegasp ( n = @ ) or biasp @ ( n = @ ) , administered with breakfast and the main evening meal and dose titrated to a self-measured premeal plasma glucose ( pg ) target of @-@ @ mmol/l . after @ weeks , mean hba@c was @ % ( @ mmol/mol ) for both groups , with idegasp achieving the prespecified noninferiority margin for mean change in hba@c ( estimated treatment difference -lsb- etd -rsb- -@ % points -lsb- @ % ci -@ to @ -rsb- ) . treatment with idegasp was superior in lowering fasting pg ( etd -@ mmol/l -lsb- @ % ci -@ to -@ -rsb- , p < @ ) and had a significantly lower final mean daily insulin dose ( estimated rate ratio @ -lsb- @ % ci @-@ @ -rsb- , p = @ ) . fewer confirmed , nocturnal confirmed , and severe hypoglycemia episodes were reported for idegasp compared with biasp @ . idegasp bid effectively improves hba@c and fasting pg levels with fewer hypoglycemia episodes versus biasp @ in patients with uncontrolled type @ diabetes previously treated with once - or twice-daily pre - or self-mixed insulin .
24,812,432
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "excessive intravenous fluid prescription may play a causal role in postoperative complications following major gastrointestinal resectional surgery .", "the aim of this study was to investigate whether fluid and salt restriction would decrease postoperative complications compared with a more modern controlled liberal regimen .", "in this observer-blinded single-site randomized clinical trial consecutive patients undergoing major gastrointestinal resectional surgery were randomized to receive either a liberal control fluid regimen or a restricted fluid and salt regimen .", "the primary outcome was postoperative complications of grade ii and above ( moderate to severe ) .", "some @ patients ( @ colorectal resections and @ oesophagogastric resections ) were enrolled in the study ; @ patients were randomized to the restricted regimen and @ to the control ( liberal ) regimen .", "during surgery the control group received a median ( interquartile range ) fluid volume of @ ( @-@ ) ml and sodium input of @ ( @-@ ) mmol , compared with @ ( @-@ ) ml and @ ( @-@ ) mmol respectively in the restricted group .", "there was no significant difference in major complication rate between groups ( @ and @ per cent respectively ) .", "median ( range ) hospital stay was @ ( @-@ ) days in the controls and @ ( range @-@ ) days among those who received restricted fluids .", "there were four in-hospital deaths in the control group and two in the restricted group .", "substantial differences in weight change , serum sodium , osmolality and urine : serum osmolality ratio were observed between the groups .", "there were no significant differences in major complication rates , length of stay and in-hospital deaths when fluid restriction was used compared with a more liberal regimen .", "isrctn@ ( http://www.controlled-trials.com ) ." ]
excessive intravenous fluid prescription may play a causal role in postoperative complications following major gastrointestinal resectional surgery . the aim of this study was to investigate whether fluid and salt restriction would decrease postoperative complications compared with a more modern controlled liberal regimen . in this observer-blinded single-site randomized clinical trial consecutive patients undergoing major gastrointestinal resectional surgery were randomized to receive either a liberal control fluid regimen or a restricted fluid and salt regimen . the primary outcome was postoperative complications of grade ii and above ( moderate to severe ) . some @ patients ( @ colorectal resections and @ oesophagogastric resections ) were enrolled in the study ; @ patients were randomized to the restricted regimen and @ to the control ( liberal ) regimen . during surgery the control group received a median ( interquartile range ) fluid volume of @ ( @-@ ) ml and sodium input of @ ( @-@ ) mmol , compared with @ ( @-@ ) ml and @ ( @-@ ) mmol respectively in the restricted group . there was no significant difference in major complication rate between groups ( @ and @ per cent respectively ) . median ( range ) hospital stay was @ ( @-@ ) days in the controls and @ ( range @-@ ) days among those who received restricted fluids . there were four in-hospital deaths in the control group and two in the restricted group . substantial differences in weight change , serum sodium , osmolality and urine : serum osmolality ratio were observed between the groups . there were no significant differences in major complication rates , length of stay and in-hospital deaths when fluid restriction was used compared with a more liberal regimen . isrctn@ ( http://www.controlled-trials.com ) .
24,227,358
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]
[ "sample size calculations for treatment trials that aim to assess health-related quality-of-life ( hrqol ) outcomes are often difficult to perform .", "researchers must select a target minimal clinically important difference ( mcid ) in hrqol for the trial , estimate the effect size of the intervention , and then consider the responsiveness of different hrqol measures for detecting improvements .", "generic preference-based hrqol measures are usually less sensitive to gains in hrqol than are disease-specific measures , but are nonetheless recommended to quantify an impact on hrqol that can be translated into quality-adjusted life-years during cost-effectiveness analyses .", "mapping disease-specific measures onto generic measures is a proposed method for yielding more efficient sample size requirements while retaining the ability to generate utility weights for cost-effectiveness analyses .", "this study sought to test this mapping strategy to calculate and compare the effect on sample size of three different methods .", "three different methods were used for determining an mcid in hrqol in patients with incontinence : @ ) a global rating of improvement , @ ) an incontinence-specific hrqol instrument , and @ ) a generic preference-based hrqol instrument using mapping coefficients .", "the sample size required to detect a @ % difference in the mcid for the global rating of improvement was @ per trial arm , @ per arm for the incontinence-specific hrqol outcome , and @ per arm for the generic preference-based hrqol outcome .", "we caution that treatment trials of conditions for which improvements are not easy to measure on generic hrqol instruments will still require significantly greater sample size even when mapping functions are used to try to gain efficiency ." ]
sample size calculations for treatment trials that aim to assess health-related quality-of-life ( hrqol ) outcomes are often difficult to perform . researchers must select a target minimal clinically important difference ( mcid ) in hrqol for the trial , estimate the effect size of the intervention , and then consider the responsiveness of different hrqol measures for detecting improvements . generic preference-based hrqol measures are usually less sensitive to gains in hrqol than are disease-specific measures , but are nonetheless recommended to quantify an impact on hrqol that can be translated into quality-adjusted life-years during cost-effectiveness analyses . mapping disease-specific measures onto generic measures is a proposed method for yielding more efficient sample size requirements while retaining the ability to generate utility weights for cost-effectiveness analyses . this study sought to test this mapping strategy to calculate and compare the effect on sample size of three different methods . three different methods were used for determining an mcid in hrqol in patients with incontinence : @ ) a global rating of improvement , @ ) an incontinence-specific hrqol instrument , and @ ) a generic preference-based hrqol instrument using mapping coefficients . the sample size required to detect a @ % difference in the mcid for the global rating of improvement was @ per trial arm , @ per arm for the incontinence-specific hrqol outcome , and @ per arm for the generic preference-based hrqol outcome . we caution that treatment trials of conditions for which improvements are not easy to measure on generic hrqol instruments will still require significantly greater sample size even when mapping functions are used to try to gain efficiency .
25,773,565
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "RESULTS", "CONCLUSIONS" ]
[ "sleep deprivation is common in critically ill patients in intensive care units ( icu ) .", "it can result in delirium , difficulty weaning , repeated nosocomial infections , prolonged icu length of stay and increased icu mortality .", "melatonin , a physiological sleep regulator , is well known to benefit sleep quality in certain people , but evidence for the effectiveness in icu sleep disturbance is limited .", "this study has a prospective , randomized , double-blind , controlled , parallel-group design .", "eligible patients are randomly assigned to one of the two treatment study groups , labelled the ` melatonin group ' or the ` placebo group ' .", "a dose of @ mg of oral melatonin or placebo is administered at @:@ pm on four consecutive days .", "earplugs and eye masks are made available to every participant .", "we plan to enrol @ patients .", "the primary outcome is the objective sleep quality measured by the @-hour polysomnography .", "the secondary outcomes are the subjective sleep quality assessed by the richards campbell sleep questionnaire , the anxiety level evaluated by the visual analogue scale-anxiety , the number of delirium-free days in @ and @ days , the number of ventilation-free days in @ days , the number of antibiotic-free days , icu length of stay , the overall icu mortality in @ days and the incidence and severity of the side effects of melatonin in icu patients .", "additionally , the body stress levels , oxidative stress levels and inflammation levels are obtained via measuring the plasma melatonin , cortisone , norepinephrine , malonaldehyde ( mda ) , superoxide dismutase ( sod ) , interleukin-@ ( il-@ ) and interleukin-@ ( il-@ ) concentrations .", "the proposed study will be the first randomized controlled study to use the polysomnography , which is the gold standard of assessing sleep quality , to evaluate the effect of melatonin on the sleep quality and circadian rhythms of icu patients .", "the results may recommend a new treatment for icu patients with sleep deprivation that is safe , effective and easily implementable in daily practice .", "this study was registered with clinicaltrials ( nct ; registration number : chictr-trc-@ ) on @ march @ ." ]
sleep deprivation is common in critically ill patients in intensive care units ( icu ) . it can result in delirium , difficulty weaning , repeated nosocomial infections , prolonged icu length of stay and increased icu mortality . melatonin , a physiological sleep regulator , is well known to benefit sleep quality in certain people , but evidence for the effectiveness in icu sleep disturbance is limited . this study has a prospective , randomized , double-blind , controlled , parallel-group design . eligible patients are randomly assigned to one of the two treatment study groups , labelled the ` melatonin group ' or the ` placebo group ' . a dose of @ mg of oral melatonin or placebo is administered at @:@ pm on four consecutive days . earplugs and eye masks are made available to every participant . we plan to enrol @ patients . the primary outcome is the objective sleep quality measured by the @-hour polysomnography . the secondary outcomes are the subjective sleep quality assessed by the richards campbell sleep questionnaire , the anxiety level evaluated by the visual analogue scale-anxiety , the number of delirium-free days in @ and @ days , the number of ventilation-free days in @ days , the number of antibiotic-free days , icu length of stay , the overall icu mortality in @ days and the incidence and severity of the side effects of melatonin in icu patients . additionally , the body stress levels , oxidative stress levels and inflammation levels are obtained via measuring the plasma melatonin , cortisone , norepinephrine , malonaldehyde ( mda ) , superoxide dismutase ( sod ) , interleukin-@ ( il-@ ) and interleukin-@ ( il-@ ) concentrations . the proposed study will be the first randomized controlled study to use the polysomnography , which is the gold standard of assessing sleep quality , to evaluate the effect of melatonin on the sleep quality and circadian rhythms of icu patients . the results may recommend a new treatment for icu patients with sleep deprivation that is safe , effective and easily implementable in daily practice . this study was registered with clinicaltrials ( nct ; registration number : chictr-trc-@ ) on @ march @ .
25,135,124
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "various studies have linked the occurrence of cardiovascular events and low ambient temperatures as well as the morning blood pressure surge ( mbps ) .", "we hypothesized that low ambient temperatures produce a higher sympathetic change during the last rapid eye movement ( rem ) sleep transition and that this may play an important role in cold-related cardiovascular events .", "all experiments were carried out on @ healthy male adults , aged @ years , who participated in two experimental conditions randomly ( > @ day apart ) : warm ( @ c ) and cold ( @c ) .", "blood pressure ( bp ) was measured every @ min for @ h by autonomic ambulatory bp monitoring .", "the electroencephalograms , electrocardiograms , ambient temperature , near-body temperature , and physical activity were recorded by miniature polysomnography for @ h.", "the cold conditions resulted in : ( i ) higher mbps than under warm conditions ; ( ii ) significant and greater sympathetic index changes during the sleep-wake transition than during cover-to-uncover and supine-to-sit position tests ; ( iii ) the non-rem-rem transition-related sympathetic elevation during the cold conditions being significantly higher in late sleep period than in early sleep period ; ( iv ) at @h prior to morning awakening , the value of total power of heart rate variability changes being significantly negatively correlated with the changes of near-body temperature ; and ( v ) significantly higher arousal index and shorter average interval of rem periods than in warm conditions .", "cold exposure elevates the amplitude of mbps and is associated with late sleep stage transition sympathetic activation , which might have important implications for cold-related cardiovascular events ." ]
various studies have linked the occurrence of cardiovascular events and low ambient temperatures as well as the morning blood pressure surge ( mbps ) . we hypothesized that low ambient temperatures produce a higher sympathetic change during the last rapid eye movement ( rem ) sleep transition and that this may play an important role in cold-related cardiovascular events . all experiments were carried out on @ healthy male adults , aged @ years , who participated in two experimental conditions randomly ( > @ day apart ) : warm ( @ c ) and cold ( @c ) . blood pressure ( bp ) was measured every @ min for @ h by autonomic ambulatory bp monitoring . the electroencephalograms , electrocardiograms , ambient temperature , near-body temperature , and physical activity were recorded by miniature polysomnography for @ h. the cold conditions resulted in : ( i ) higher mbps than under warm conditions ; ( ii ) significant and greater sympathetic index changes during the sleep-wake transition than during cover-to-uncover and supine-to-sit position tests ; ( iii ) the non-rem-rem transition-related sympathetic elevation during the cold conditions being significantly higher in late sleep period than in early sleep period ; ( iv ) at @h prior to morning awakening , the value of total power of heart rate variability changes being significantly negatively correlated with the changes of near-body temperature ; and ( v ) significantly higher arousal index and shorter average interval of rem periods than in warm conditions . cold exposure elevates the amplitude of mbps and is associated with late sleep stage transition sympathetic activation , which might have important implications for cold-related cardiovascular events .
25,011,661
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS" ]
[ "dignity therapy is a brief psychotherapy developed for patients living with a life-limiting illness .", "to determine the influence of dignity therapy on depression and anxiety in inpatients with a terminal illness and experiencing a high level of distress in a palliative care unit .", "a nonblinded phase ii randomized controlled trial of @ patients who were randomly assigned to one of two groups : intervention group ( dignity therapy + standard palliative care -lsb- spc -rsb- ) or control group ( spc alone ) .", "the main outcomes were depression and anxiety scores , as measured with the hospital anxiety and depression scale , and assessed at baseline ( t@ ) , day @ ( t@ ) , day @ ( t@ ) , and day @ ( t@ ) of follow-up .", "this study is registered with www.controlled-trials.com/isrctn@ .", "of the final @ participants , @ were randomly assigned to spc and @ to dignity therapy .", "baseline characteristics were similar between the two groups .", "dignity therapy was associated with a decrease in depression scores ( median , @ % confidence interval -lsb- ci -rsb- : -@ , -@ to -@ , p < @ ; -@ , -@ to -@ , p = @ ; -@ , -@ to -@ , p = @ , for t@ , t@ , and t@ , respectively ) .", "dignity therapy was similarly associated with a decrease in anxiety scores ( median , @ % ci : -@ , -@ to -@ , p < @ ; -@ , -@ to -@ , p = @ ; -@ , -@ to -@ , p = @ , for t@ , t@ , and t@ , respectively ) .", "dignity therapy resulted in a beneficial effect on depression and anxiety symptoms in end-of-life care .", "the therapeutic benefit of dignity therapy was sustained over a @-day period .", "having established its efficacy , future trials of dignity therapy may now begin , comparing it with other psychotherapeutic approaches within the context of terminal illness ." ]
dignity therapy is a brief psychotherapy developed for patients living with a life-limiting illness . to determine the influence of dignity therapy on depression and anxiety in inpatients with a terminal illness and experiencing a high level of distress in a palliative care unit . a nonblinded phase ii randomized controlled trial of @ patients who were randomly assigned to one of two groups : intervention group ( dignity therapy + standard palliative care -lsb- spc -rsb- ) or control group ( spc alone ) . the main outcomes were depression and anxiety scores , as measured with the hospital anxiety and depression scale , and assessed at baseline ( t@ ) , day @ ( t@ ) , day @ ( t@ ) , and day @ ( t@ ) of follow-up . this study is registered with www.controlled-trials.com/isrctn@ . of the final @ participants , @ were randomly assigned to spc and @ to dignity therapy . baseline characteristics were similar between the two groups . dignity therapy was associated with a decrease in depression scores ( median , @ % confidence interval -lsb- ci -rsb- : -@ , -@ to -@ , p < @ ; -@ , -@ to -@ , p = @ ; -@ , -@ to -@ , p = @ , for t@ , t@ , and t@ , respectively ) . dignity therapy was similarly associated with a decrease in anxiety scores ( median , @ % ci : -@ , -@ to -@ , p < @ ; -@ , -@ to -@ , p = @ ; -@ , -@ to -@ , p = @ , for t@ , t@ , and t@ , respectively ) . dignity therapy resulted in a beneficial effect on depression and anxiety symptoms in end-of-life care . the therapeutic benefit of dignity therapy was sustained over a @-day period . having established its efficacy , future trials of dignity therapy may now begin , comparing it with other psychotherapeutic approaches within the context of terminal illness .
24,735,024
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to demonstrate that administering heparanase inhibitor pi-@ at @ mg/d is safe and promising in reducing hepatocellular carcinoma ( hcc ) recurrence for up to @ year following curative resection .", "a total of @ patients ( @ % of the @ participants in the phase ii study ) participated in the follow-up study .", "of these patients , @ had received no treatment , @ had received @ mg/d pi-@ , and @ had received @ mg/d pi-@ during the phase ii trial .", "safety parameters and the following efficacy endpoints were investigated : ( @ ) time to recurrence ; ( @ ) disease-free survival ; and ( @ ) overall survival .", "pi-@ at @ mg/d delayed the onset and frequency of hcc recurrence , and provided a clinically significant survival advantage for up to @ years after treatment compared with those of the control group : ( @ ) the recurrence-free rate increased from @ % to @ % , and ( @ ) time to recurrence at the @th percentile was postponed by @ % .", "the efficacy of administering pi-@ at @ mg/d was confounded by a high dropout rate ( @ out of @ patients ) .", "additionally , subgroup analyses of patients with ( @ ) multiple tumors or a single tumor @ cm ; and ( @ ) hepatitis b or c revealed that administering pi-@ at @ mg/d conferred the most significant survival advantage ( @ % improvement in disease-free survival , p = @ ) for patients with both risk factors for recurrence .", "administering pi-@ at @ mg/d is a safe and well-tolerated dosage that may confer significant clinical benefits for patients with hcc ." ]
to demonstrate that administering heparanase inhibitor pi-@ at @ mg/d is safe and promising in reducing hepatocellular carcinoma ( hcc ) recurrence for up to @ year following curative resection . a total of @ patients ( @ % of the @ participants in the phase ii study ) participated in the follow-up study . of these patients , @ had received no treatment , @ had received @ mg/d pi-@ , and @ had received @ mg/d pi-@ during the phase ii trial . safety parameters and the following efficacy endpoints were investigated : ( @ ) time to recurrence ; ( @ ) disease-free survival ; and ( @ ) overall survival . pi-@ at @ mg/d delayed the onset and frequency of hcc recurrence , and provided a clinically significant survival advantage for up to @ years after treatment compared with those of the control group : ( @ ) the recurrence-free rate increased from @ % to @ % , and ( @ ) time to recurrence at the @th percentile was postponed by @ % . the efficacy of administering pi-@ at @ mg/d was confounded by a high dropout rate ( @ out of @ patients ) . additionally , subgroup analyses of patients with ( @ ) multiple tumors or a single tumor @ cm ; and ( @ ) hepatitis b or c revealed that administering pi-@ at @ mg/d conferred the most significant survival advantage ( @ % improvement in disease-free survival , p = @ ) for patients with both risk factors for recurrence . administering pi-@ at @ mg/d is a safe and well-tolerated dosage that may confer significant clinical benefits for patients with hcc .
25,170,226
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "a computerized intervention-management-system ( ims ) has been developed and implemented to facilitate dementia care management .", "ims is a rule-based expert decision support system that matches individual patient characteristics to a computerized knowledge base .", "one of the most important functionalities of ims is to support the compilation of the individual intervention plan by systematically identifying unmet needs and suggesting the corresponding specific interventions for recommendation to the general practitioner ( gp ) .", "the present analysis aimed to determine if the implementation of ims improves the identification of unmet needs and the recommendation of adequate specific interventions .", "in addition , the feasibility and acceptability of the ims were evaluated .", "delphi-mv is an on-going gp-based , cluster-randomized , controlled intervention trial to implement and evaluate a collaborative dementia care management program for community-dwelling pwds and their caregivers .", "ims was developed and implemented over the course of the delphi-trial .", "the identified unmet needs and the interventions that were recommended to the gp before and after the implementation of ims were compared .", "to evaluate the feasibility and acceptability of the ims , a survey was conducted among the current users of ims .", "after the implementation of ims , the number of specific interventions recommended to the gp increased by @ % .", "our findings provide evidence that ims improves the systematic identification of unmet needs and the subsequent recommendation of interventions to address these needs .", "the users evaluated ims as very helpful and would like to use it for their future work .", "however , the usability could be further improved ." ]
a computerized intervention-management-system ( ims ) has been developed and implemented to facilitate dementia care management . ims is a rule-based expert decision support system that matches individual patient characteristics to a computerized knowledge base . one of the most important functionalities of ims is to support the compilation of the individual intervention plan by systematically identifying unmet needs and suggesting the corresponding specific interventions for recommendation to the general practitioner ( gp ) . the present analysis aimed to determine if the implementation of ims improves the identification of unmet needs and the recommendation of adequate specific interventions . in addition , the feasibility and acceptability of the ims were evaluated . delphi-mv is an on-going gp-based , cluster-randomized , controlled intervention trial to implement and evaluate a collaborative dementia care management program for community-dwelling pwds and their caregivers . ims was developed and implemented over the course of the delphi-trial . the identified unmet needs and the interventions that were recommended to the gp before and after the implementation of ims were compared . to evaluate the feasibility and acceptability of the ims , a survey was conducted among the current users of ims . after the implementation of ims , the number of specific interventions recommended to the gp increased by @ % . our findings provide evidence that ims improves the systematic identification of unmet needs and the subsequent recommendation of interventions to address these needs . the users evaluated ims as very helpful and would like to use it for their future work . however , the usability could be further improved .
24,811,145
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to compare clinical and morphological results of treatment of ischemic stroke in three groups of patients which differed by the forms and duration of an antioxidant therapy .", "a randomized clinical trial was performed in @ vascular centers of the russian federation in @-@ .", "it included @ patients with ischemic stroke in the carotid territory .", "patients were randomized into @ groups to receive different regimens of antioxidant therapy as an adjunct to standard therapy : control group ( ascorbic acid ; @ patients ) ; cytoflavin ( @ ml per day for @ days ; @ patients ) ; cytoflavin ( the dose was decreased to @ ml per day from @th to @th day ) ( @ patients ) .", "patient 's condition was assessed in @ , @ and @ day by a complex of clinical , laboratory and instrumental methods .", "the analysis of ct in @th and @th day revealed a significant @,@-@ ,@ - fold decrease in the cerebral ischemic lesion in both groups treated with cytoflavin with no significant morphologic changes in the ascorbic acid group .", "the percentage of patients with ischemic lesion , increased during days @-@ , was @-fold higher in the ascorbic acid group compared to cytoflavin groups .", "morphologic changes were correlated with clinical variables and outcome .", "in patients with @ points on nih scale on admission , prolonged @ day cytoflavin therapy was associated with a more prominent improvement of neurologic , functional and cognitive status compared to @-day cytoflavin infusion .", "no differences in clinical variables were observed in patients with mild symptoms ( < @ points on nih scale on admission ) receiving cytoflavin for @ and @ days ." ]
to compare clinical and morphological results of treatment of ischemic stroke in three groups of patients which differed by the forms and duration of an antioxidant therapy . a randomized clinical trial was performed in @ vascular centers of the russian federation in @-@ . it included @ patients with ischemic stroke in the carotid territory . patients were randomized into @ groups to receive different regimens of antioxidant therapy as an adjunct to standard therapy : control group ( ascorbic acid ; @ patients ) ; cytoflavin ( @ ml per day for @ days ; @ patients ) ; cytoflavin ( the dose was decreased to @ ml per day from @th to @th day ) ( @ patients ) . patient 's condition was assessed in @ , @ and @ day by a complex of clinical , laboratory and instrumental methods . the analysis of ct in @th and @th day revealed a significant @,@-@ ,@ - fold decrease in the cerebral ischemic lesion in both groups treated with cytoflavin with no significant morphologic changes in the ascorbic acid group . the percentage of patients with ischemic lesion , increased during days @-@ , was @-fold higher in the ascorbic acid group compared to cytoflavin groups . morphologic changes were correlated with clinical variables and outcome . in patients with @ points on nih scale on admission , prolonged @ day cytoflavin therapy was associated with a more prominent improvement of neurologic , functional and cognitive status compared to @-day cytoflavin infusion . no differences in clinical variables were observed in patients with mild symptoms ( < @ points on nih scale on admission ) receiving cytoflavin for @ and @ days .
26,356,615
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "secondary arm lymphoedema continues to affect at least @ % of women after treatment for breast cancer requiring lifelong professional treatment and self-management .", "the holistic practice of yoga may offer benefits as an adjunct self-management option .", "the aim of this small pilot trial was to gain preliminary data to determine the effect of yoga on women with stage one breast cancer-related lymphoedema ( bcrl ) .", "this paper reports the results for the primary and secondary outcomes .", "participants were randomised , after baseline testing , to receive either an @-week yoga intervention ( n = @ ) , consisting of a weekly @-minute teacher-led class and a @-minute daily session delivered by dvd , or to a usual care wait-listed control group ( n = @ ) .", "primary outcome measures were : arm volume of lymphoedema measured by circumference and extra-cellular fluid measured by bioimpedance spectroscopy .", "secondary outcome measures were : tissue induration measured by tonometry ; levels of sensations , pain , fatigue , and their limiting effects all measured by a visual analogue scale ( vas ) and quality of life based on the lymphoedema quality of life tool ( lymqol ) .", "measurements were conducted at baseline , week @ ( post-intervention ) and week @ ( four weeks after cessation of the intervention ) .", "at week @ , the intervention group had a greater decrease in tissue induration of the affected upper arm compared to the control group ( p = @ ) , as well as a greater reduction in the symptom sub-scale for qol ( p = @ ) .", "there was no difference in arm volume of lymphoedema or extra-cellular fluid between groups at week @ ; however , at week @ , arm volume increased more for the intervention group than the control group ( p = @ ) .", "an @-week yoga intervention reduced tissue induration of the affected upper arm and decreased the qol sub-scale of symptoms .", "arm volume of lymphoedema and extra-cellular fluid did not increase .", "these benefits did not last on cessation of the intervention when arm volume of lymphoedema increased .", "further research trials with a longer duration , higher levels of lymphoedema and larger numbers are warranted before definitive conclusions can be made ." ]
secondary arm lymphoedema continues to affect at least @ % of women after treatment for breast cancer requiring lifelong professional treatment and self-management . the holistic practice of yoga may offer benefits as an adjunct self-management option . the aim of this small pilot trial was to gain preliminary data to determine the effect of yoga on women with stage one breast cancer-related lymphoedema ( bcrl ) . this paper reports the results for the primary and secondary outcomes . participants were randomised , after baseline testing , to receive either an @-week yoga intervention ( n = @ ) , consisting of a weekly @-minute teacher-led class and a @-minute daily session delivered by dvd , or to a usual care wait-listed control group ( n = @ ) . primary outcome measures were : arm volume of lymphoedema measured by circumference and extra-cellular fluid measured by bioimpedance spectroscopy . secondary outcome measures were : tissue induration measured by tonometry ; levels of sensations , pain , fatigue , and their limiting effects all measured by a visual analogue scale ( vas ) and quality of life based on the lymphoedema quality of life tool ( lymqol ) . measurements were conducted at baseline , week @ ( post-intervention ) and week @ ( four weeks after cessation of the intervention ) . at week @ , the intervention group had a greater decrease in tissue induration of the affected upper arm compared to the control group ( p = @ ) , as well as a greater reduction in the symptom sub-scale for qol ( p = @ ) . there was no difference in arm volume of lymphoedema or extra-cellular fluid between groups at week @ ; however , at week @ , arm volume increased more for the intervention group than the control group ( p = @ ) . an @-week yoga intervention reduced tissue induration of the affected upper arm and decreased the qol sub-scale of symptoms . arm volume of lymphoedema and extra-cellular fluid did not increase . these benefits did not last on cessation of the intervention when arm volume of lymphoedema increased . further research trials with a longer duration , higher levels of lymphoedema and larger numbers are warranted before definitive conclusions can be made .
24,980,836
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to evaluate effects of different treatments on patients with osteoporotic vertebral fracture after percutaneous kyphoplasty in pain and function .", "from march @ to march @,@ patients ( @ vertebrae ) with thoracic and lumbar vertebral osteoporotic fracture were randomly divided into three groups ( control group , treatment group and comprehensive group ) , @ cases in each group , and all patients were treated by pkp .", "control group were treated with calcium and calcitriol after operation , treatment group added salmon calcitonin see calcimar based on control group , comprehensive group added incrementality waist musculi dorsi function exercise based on treatment group .", "vas , odi scores and bmd before operation , @ d , @ weeks , @ month , @ months and @ months after operation were detected and compared .", "all operation were performed successfully ,@ cases ( @ vertebrae ) in control group , @ cases ( @ vertebrae ) in treatment group and @ cases ( @ vertebrae ) were obtained complete following up , there was no significant meaning in following time among three groups ( p > @ ) .", "postoperative vas and odi scores at @ d , @ weeks and @ month among three groups were lower than that of before operation ( p < @ ) .", "compared with control group , postoperative vas score at @ d , @ weeks and @ month were decreasedin treatment group and comprehensive group , but there was no significant meaning in odi scores ( p > @ ) .", "at @ and @ months after operation , there was no significant differences in vas and odi between control group and treatment group ( p > @ ) , while vas score in comprehensive group decreased much than other two groups , decreased continuously ( p < @ ) .", "at @ months after operation , bmd among three groups were increased more than preoperative , and bmd in comprehensive group was more obviously than that of in control and treatment group .", "pkp , an effective method for the treatment of thoracic and lumbar vertebral osteoporotic fracture , could improve short-term clinical effects by adding calcitonin with calcium supplements and activated vitamin d. waist musculi dorsi function exercise could improve long-term clinical effects of pkp and improve quality of life ." ]
to evaluate effects of different treatments on patients with osteoporotic vertebral fracture after percutaneous kyphoplasty in pain and function . from march @ to march @,@ patients ( @ vertebrae ) with thoracic and lumbar vertebral osteoporotic fracture were randomly divided into three groups ( control group , treatment group and comprehensive group ) , @ cases in each group , and all patients were treated by pkp . control group were treated with calcium and calcitriol after operation , treatment group added salmon calcitonin see calcimar based on control group , comprehensive group added incrementality waist musculi dorsi function exercise based on treatment group . vas , odi scores and bmd before operation , @ d , @ weeks , @ month , @ months and @ months after operation were detected and compared . all operation were performed successfully ,@ cases ( @ vertebrae ) in control group , @ cases ( @ vertebrae ) in treatment group and @ cases ( @ vertebrae ) were obtained complete following up , there was no significant meaning in following time among three groups ( p > @ ) . postoperative vas and odi scores at @ d , @ weeks and @ month among three groups were lower than that of before operation ( p < @ ) . compared with control group , postoperative vas score at @ d , @ weeks and @ month were decreasedin treatment group and comprehensive group , but there was no significant meaning in odi scores ( p > @ ) . at @ and @ months after operation , there was no significant differences in vas and odi between control group and treatment group ( p > @ ) , while vas score in comprehensive group decreased much than other two groups , decreased continuously ( p < @ ) . at @ months after operation , bmd among three groups were increased more than preoperative , and bmd in comprehensive group was more obviously than that of in control and treatment group . pkp , an effective method for the treatment of thoracic and lumbar vertebral osteoporotic fracture , could improve short-term clinical effects by adding calcitonin with calcium supplements and activated vitamin d. waist musculi dorsi function exercise could improve long-term clinical effects of pkp and improve quality of life .
26,255,474
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the purpose of this study was to compare the efficacy of orally administered propranolol versus prednisolone versus both in the treatment of potentially disfiguring or functionally threatening infantile hemangiomas .", "a prospective study of @ patients aged @ week-@ months was randomized into three equal groups .", "these were as follows : a , propranolol ( @-@ mg/kg/d ) ; b , prednisolone ( @-@ mg/kg/d ) ; and c , receiving both for a minimum duration of @ months .", "dimensions , color , consistency , ultrasonography , photographic documentation based on visual analogue scale ( vas ) were recorded before and periodically after starting treatment .", "a minimum @ % improvement was considered as success with no regrowth up to @ month of stopping treatment .", "mean initial response time ( days ) in a ( @ sd ) and c ( @ sd ) was significantly lower than b ( @ sd ) ( p < @ ) .", "significant change in consistency was noted very early in a ( @ hours ) compared to b and c ( @ days ) .", "vas results are as follows : ( a ) color fading -- significant reduction in a within @ hours compared to b and c ( p = @ ) , ( b ) flattening -- more significant and earlier in a and c than b ( p < @ ) , and ( c ) mean reduction in size : significant in a and c at @ months ( p = @ , p = @ ) , @ months ( p = @ , p = @ ) , @ months ( p = @ , p = @ ) , and @ months ( p = @ , p = @ ) , whereas in b , it was seen only at @ months ( p = @ ) .", "propranolol had a consistent , rapid therapeutic effect compared to prednisolone .", "a combination of the two had a comparable but not higher efficacy than propranolol alone .", "prednisolone was associated with a higher number of complications , thereby decreasing patient compliance ." ]
the purpose of this study was to compare the efficacy of orally administered propranolol versus prednisolone versus both in the treatment of potentially disfiguring or functionally threatening infantile hemangiomas . a prospective study of @ patients aged @ week-@ months was randomized into three equal groups . these were as follows : a , propranolol ( @-@ mg/kg/d ) ; b , prednisolone ( @-@ mg/kg/d ) ; and c , receiving both for a minimum duration of @ months . dimensions , color , consistency , ultrasonography , photographic documentation based on visual analogue scale ( vas ) were recorded before and periodically after starting treatment . a minimum @ % improvement was considered as success with no regrowth up to @ month of stopping treatment . mean initial response time ( days ) in a ( @ sd ) and c ( @ sd ) was significantly lower than b ( @ sd ) ( p < @ ) . significant change in consistency was noted very early in a ( @ hours ) compared to b and c ( @ days ) . vas results are as follows : ( a ) color fading -- significant reduction in a within @ hours compared to b and c ( p = @ ) , ( b ) flattening -- more significant and earlier in a and c than b ( p < @ ) , and ( c ) mean reduction in size : significant in a and c at @ months ( p = @ , p = @ ) , @ months ( p = @ , p = @ ) , @ months ( p = @ , p = @ ) , and @ months ( p = @ , p = @ ) , whereas in b , it was seen only at @ months ( p = @ ) . propranolol had a consistent , rapid therapeutic effect compared to prednisolone . a combination of the two had a comparable but not higher efficacy than propranolol alone . prednisolone was associated with a higher number of complications , thereby decreasing patient compliance .
24,314,186
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "this study aimed to evaluate the effectiveness of transcutaneous electrical nerve stimulation ( tens ) for treatment of postoperative pain and pulmonary functions ( vital capacity -lsb- vc -rsb- ; cough peak flow , -lsb- cpf -rsb- ) in patients who underwent abdominal surgery .", "forty-eight patients were randomly allocated to receive tens , placebo tens , or no tens ( control ) @ hour a day for @ days postoperatively .", "a @-@ visual analog scale was used to assess pain at preintervention , mid-intervention , and postintervention on the third postoperative day .", "pulmonary functions ( vc , cpf ) were evaluated by spirometer at preoperation ( baseline ) and at preintervention , mid-intervention , and postintervention on the third postoperative day .", "one-way analysis of variance was used to assess differences between groups at baseline .", "mann-whitney test was used to compare the control group with the placebo-tens and tens group , at each assessment timepoint .", "two-way analysis of variance and bonferroni post hoc test assessed the difference between the @ ( placebo-tenstens ) groups .", "a value of p < @ was considered statistically significant .", "the baselines were not significantly different between any groups .", "the tens group had significant reductions in postoperative pain compared with the placebo group ( p < @ ) and control group ( p < @ ) .", "there was also improvement in pulmonary functions ( vc , cpf ) at mid-tens and post-tens , but not in the placebo-tens ( p < @ ) or control groups ( p < @ ) .", "tens is a valuable treatment to alleviate postoperative pain and improve pulmonary functions ( ie , vc , cpf ) in patients following abdominal surgery ." ]
this study aimed to evaluate the effectiveness of transcutaneous electrical nerve stimulation ( tens ) for treatment of postoperative pain and pulmonary functions ( vital capacity -lsb- vc -rsb- ; cough peak flow , -lsb- cpf -rsb- ) in patients who underwent abdominal surgery . forty-eight patients were randomly allocated to receive tens , placebo tens , or no tens ( control ) @ hour a day for @ days postoperatively . a @-@ visual analog scale was used to assess pain at preintervention , mid-intervention , and postintervention on the third postoperative day . pulmonary functions ( vc , cpf ) were evaluated by spirometer at preoperation ( baseline ) and at preintervention , mid-intervention , and postintervention on the third postoperative day . one-way analysis of variance was used to assess differences between groups at baseline . mann-whitney test was used to compare the control group with the placebo-tens and tens group , at each assessment timepoint . two-way analysis of variance and bonferroni post hoc test assessed the difference between the @ ( placebo-tenstens ) groups . a value of p < @ was considered statistically significant . the baselines were not significantly different between any groups . the tens group had significant reductions in postoperative pain compared with the placebo group ( p < @ ) and control group ( p < @ ) . there was also improvement in pulmonary functions ( vc , cpf ) at mid-tens and post-tens , but not in the placebo-tens ( p < @ ) or control groups ( p < @ ) . tens is a valuable treatment to alleviate postoperative pain and improve pulmonary functions ( ie , vc , cpf ) in patients following abdominal surgery .
24,901,753
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "cerebrospinal fluid leakage is an immanent risk of cranial surgery with dural opening .", "recognizing the risk factors for this complication and improving the technique of dural closure may reduce the associated morbidity and its surgical burden .", "the aim of this paper was to investigate whether the addition of tachosil on top of the dural suture reduces postoperative csf leakage compared with dural suturing alone and to assess the frequency and risk factors for dural leakage and potentially related complications after elective craniotomy .", "the authors conducted a prospective , randomized , double-blinded single-center trial in patients undergoing elective craniotomy with dural opening .", "they compared their standard dural closure by running suture alone ( with the use of a dural patch if needed ) to the same closure with the addition of tachosil on top of the suture .", "the primary end point was the incidence of csf leakage , defined as csf collection or any open csf fistula within @ days .", "secondary end points were the incidence of infection , surgical revision , and length of stay in the intensive care unit ( icu ) or intermediate care ( imc ) unit .", "the site of craniotomy , a history of diabetes mellitus , a diagnosis of meningioma , the intraoperative need of a suturable dural substitute , and blood parameters were assessed as potential risk factors for csf leakage .", "the authors enrolled @ patients , of whom @ were included in the analysis .", "cerebrospinal fluid leakage , mostly self-limiting subgaleal collections , occurred in @ % of patients .", "invasive treatment was performed in @ patients ( @ % ) ( subgaleal puncture in @ , lumbar drainage in @ , and surgical revision in @ patient ) .", "diabetes mellitus , a higher preoperative level of c-reactive protein ( crp ) , and the intraoperative need for a dural patch were positively associated with the occurrence of the primary end point ( p = @ , @ , and @ , respectively ) .", "cerebrospinal fluid leakage ( @ % vs @ % , or @ -lsb- @ % ci @-@ @ -rsb- , p = @ ) and infection ( or @ -lsb- @ % ci @-@ @ -rsb- , p = @ ) occurred less frequently in the study group than in the control group .", "tachosil significantly reduced the probability of staying in the imc unit for @ day or longer ( or @ -lsb- @ % ci @-@ @ -rsb- , p = @ ) .", "postoperative epidural hematoma and empyema occurred in the control group but not in the study group .", "dural leakage after elective craniotomy/durotomy occurs more frequently in association with diabetes mellitus , elevated preoperative crp levels , and the intraoperative need of a dural patch .", "this randomized controlled trial showed no statistically significant reduction of postoperative csf leakage and surgical site infections upon addition of tachosil on the dural suture , but there was a significant reduction in the length of stay in the imc unit .", "dural augmentation with tachosil was safe and not related to adverse events .", "clinical trial registration no .", "nct@ ( http://www.clinicaltrials.gov ) ." ]
cerebrospinal fluid leakage is an immanent risk of cranial surgery with dural opening . recognizing the risk factors for this complication and improving the technique of dural closure may reduce the associated morbidity and its surgical burden . the aim of this paper was to investigate whether the addition of tachosil on top of the dural suture reduces postoperative csf leakage compared with dural suturing alone and to assess the frequency and risk factors for dural leakage and potentially related complications after elective craniotomy . the authors conducted a prospective , randomized , double-blinded single-center trial in patients undergoing elective craniotomy with dural opening . they compared their standard dural closure by running suture alone ( with the use of a dural patch if needed ) to the same closure with the addition of tachosil on top of the suture . the primary end point was the incidence of csf leakage , defined as csf collection or any open csf fistula within @ days . secondary end points were the incidence of infection , surgical revision , and length of stay in the intensive care unit ( icu ) or intermediate care ( imc ) unit . the site of craniotomy , a history of diabetes mellitus , a diagnosis of meningioma , the intraoperative need of a suturable dural substitute , and blood parameters were assessed as potential risk factors for csf leakage . the authors enrolled @ patients , of whom @ were included in the analysis . cerebrospinal fluid leakage , mostly self-limiting subgaleal collections , occurred in @ % of patients . invasive treatment was performed in @ patients ( @ % ) ( subgaleal puncture in @ , lumbar drainage in @ , and surgical revision in @ patient ) . diabetes mellitus , a higher preoperative level of c-reactive protein ( crp ) , and the intraoperative need for a dural patch were positively associated with the occurrence of the primary end point ( p = @ , @ , and @ , respectively ) . cerebrospinal fluid leakage ( @ % vs @ % , or @ -lsb- @ % ci @-@ @ -rsb- , p = @ ) and infection ( or @ -lsb- @ % ci @-@ @ -rsb- , p = @ ) occurred less frequently in the study group than in the control group . tachosil significantly reduced the probability of staying in the imc unit for @ day or longer ( or @ -lsb- @ % ci @-@ @ -rsb- , p = @ ) . postoperative epidural hematoma and empyema occurred in the control group but not in the study group . dural leakage after elective craniotomy/durotomy occurs more frequently in association with diabetes mellitus , elevated preoperative crp levels , and the intraoperative need of a dural patch . this randomized controlled trial showed no statistically significant reduction of postoperative csf leakage and surgical site infections upon addition of tachosil on the dural suture , but there was a significant reduction in the length of stay in the imc unit . dural augmentation with tachosil was safe and not related to adverse events . clinical trial registration no . nct@ ( http://www.clinicaltrials.gov ) .
25,036,199
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to assess over a @-month period functional results of the modified intracor femtosecond laser-based intrastromal procedure to treat presbyopia .", "@ eyes of @ presbyopic patients with mild hyperopia were included .", "the intracor procedure with a modified pattern ( six concentric intrastromal ring cuts ) was performed using the femtec femtosecond laser ( bausch + lomb/technolas perfect vision , munich , germany ) .", "patients were also randomly divided into three subgroups to compare the effect of three different small inner ring diameters ( @ / @ / @ mm ( groups a/b/c ) ) .", "follow-up examinations were performed at @ , @ , @ , @ , @ and @months , and included near and distance visual acuity tests , slit-lamp examinations and corneal topography .", "median uncorrected near visual acuity ( unva ) increased from @ / @ / @ logmar ( groups a/b/c ) to -@ / @ / @ logmar @months after surgery .", "uncorrected distance visual acuity changed slightly from @ / @ / @ logmar to @ / @ / @ logmar .", "losses of two lines of binocular corrected distance visual acuity ( cdva ) were noted in @/@/@ % of eyes .", "median spherical equivalent changed from @ / @ / @ dioptres to -@ / @ / -@ dioptres .", "overall patient satisfaction with the procedure was @ % .", "intracor with a modified pattern improved unva in all patients over a @-month follow-up period .", "the possibility of reduced cdva underlines the need for careful patient selection .", "nct@ ." ]
to assess over a @-month period functional results of the modified intracor femtosecond laser-based intrastromal procedure to treat presbyopia . @ eyes of @ presbyopic patients with mild hyperopia were included . the intracor procedure with a modified pattern ( six concentric intrastromal ring cuts ) was performed using the femtec femtosecond laser ( bausch + lomb/technolas perfect vision , munich , germany ) . patients were also randomly divided into three subgroups to compare the effect of three different small inner ring diameters ( @ / @ / @ mm ( groups a/b/c ) ) . follow-up examinations were performed at @ , @ , @ , @ , @ and @months , and included near and distance visual acuity tests , slit-lamp examinations and corneal topography . median uncorrected near visual acuity ( unva ) increased from @ / @ / @ logmar ( groups a/b/c ) to -@ / @ / @ logmar @months after surgery . uncorrected distance visual acuity changed slightly from @ / @ / @ logmar to @ / @ / @ logmar . losses of two lines of binocular corrected distance visual acuity ( cdva ) were noted in @/@/@ % of eyes . median spherical equivalent changed from @ / @ / @ dioptres to -@ / @ / -@ dioptres . overall patient satisfaction with the procedure was @ % . intracor with a modified pattern improved unva in all patients over a @-month follow-up period . the possibility of reduced cdva underlines the need for careful patient selection . nct@ .
25,185,255
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "to observe the effect of medicinal-cake-separated moxibustion combined with acupuncture on back-leg activities and plasma substance p ( sp ) levels in patients with lumbar disc herniation , so as to reveal its mechanism underlying pain relief .", "a total of @ patients with lumbar disc herniation were randomly divided into control group ( n = @ ) and treatment group ( n = @ ) according to a random digits table .", "patients of the control group were treated by manual acupuncture stimulation of main acupoints jiaji ( ex-b @ ) , huantiao ( gb @ , affected side ) , chengshan ( bl @ , affected side ) , kunlun ( bl @ , affected side ) , and supplemented acupoints yanglingquan ( gb @ ) , weizhong ( bl @ ) and zusanli ( st @ ) in combination with wheat-flour-cake separated moxibustion at the main acupoints , and patients of the treatment group were treated by medicinal-cake -lsb- chuanwu ( radix aconiti ) , caowu ( radix aconiti kusnezoffii ) , ruxiang ( olibanum ) , etc. -rsb- - separated moxibustion in combination with manual acupuncture stimulation of the same acupoints mentioned above .", "acupuncture treatment was conducted for @ min , followed by moxibustion for @ min .", "the treatment was given once daily for @ days .", "the patients ' back-leg functional activity ability was assessed using straight-leg raising test , and the pain state assessed using visual analogue scale ( vas ) and japanese orthopaedic association ( joa ) scores , respectively .", "the therapeutic effect was evaluated by using `` crite - ria for diagnosis and outcome evaluation of clinical disorders or syndromes of chinese medicine '' issued in @ and plasma sp content was detected by radioimmunoassay .", "after the therapy , the back-leg activity score and joa score of both groups were significantly higher than those of pre-treatment in the same one group ( p < @ , p < @ ) , and those of the treatment group were significantly higher than those of the control group ( p < @ ) .", "the vas score of the treatment group was re - markably lower than that of the control group ( p < @ ) .", "after the treatment , the plasma sp content was markedly lower in the treatment group than in the control group ( .", "p < @o .", "@ ) .", "medicinal-cake-separated moxibustion therapy can ame - liorate pain severity and functional activity of the back-leg pain patients with lumbar disc hernia , which may be related to its effect in reducing blood sp level ." ]
to observe the effect of medicinal-cake-separated moxibustion combined with acupuncture on back-leg activities and plasma substance p ( sp ) levels in patients with lumbar disc herniation , so as to reveal its mechanism underlying pain relief . a total of @ patients with lumbar disc herniation were randomly divided into control group ( n = @ ) and treatment group ( n = @ ) according to a random digits table . patients of the control group were treated by manual acupuncture stimulation of main acupoints jiaji ( ex-b @ ) , huantiao ( gb @ , affected side ) , chengshan ( bl @ , affected side ) , kunlun ( bl @ , affected side ) , and supplemented acupoints yanglingquan ( gb @ ) , weizhong ( bl @ ) and zusanli ( st @ ) in combination with wheat-flour-cake separated moxibustion at the main acupoints , and patients of the treatment group were treated by medicinal-cake -lsb- chuanwu ( radix aconiti ) , caowu ( radix aconiti kusnezoffii ) , ruxiang ( olibanum ) , etc. -rsb- - separated moxibustion in combination with manual acupuncture stimulation of the same acupoints mentioned above . acupuncture treatment was conducted for @ min , followed by moxibustion for @ min . the treatment was given once daily for @ days . the patients ' back-leg functional activity ability was assessed using straight-leg raising test , and the pain state assessed using visual analogue scale ( vas ) and japanese orthopaedic association ( joa ) scores , respectively . the therapeutic effect was evaluated by using `` crite - ria for diagnosis and outcome evaluation of clinical disorders or syndromes of chinese medicine '' issued in @ and plasma sp content was detected by radioimmunoassay . after the therapy , the back-leg activity score and joa score of both groups were significantly higher than those of pre-treatment in the same one group ( p < @ , p < @ ) , and those of the treatment group were significantly higher than those of the control group ( p < @ ) . the vas score of the treatment group was re - markably lower than that of the control group ( p < @ ) . after the treatment , the plasma sp content was markedly lower in the treatment group than in the control group ( . p < @o . @ ) . medicinal-cake-separated moxibustion therapy can ame - liorate pain severity and functional activity of the back-leg pain patients with lumbar disc hernia , which may be related to its effect in reducing blood sp level .
25,632,576
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to evaluate the efficacy and safety of etanercept plus tripterygium wilfordii polyglycoside ( twp ) in elderly patients with active rheumatoid arthritis ( ra ) .", "totally @ elderly patients with active ra were randomly assigned to the treatment group ( @ cases ) and the control group ( @ cases ) .", "all patients received subcutaneous injection of etanercept , @ mg each time , twice per week .", "the dosage was reduced to once per week @ months later .", "patients in the treatment group took twp tablet ( @ mg each time , three times per day ) , while those in the control group took methotrexate ( mtx ) , @ mg each time , once per week .", "the whole course lasted for @ weeks .", "patients ' rest pain , tender joint number , swollen joint number , health assessment questionnaire ( haq ) , patients ' global assessment , physicians ' global assessment , erythrocyte sediment rate ( esr ) , c reactive protein ( crp ) , rheumatic factor were assessed at week @ , @ , @ , @ , and @ .", "the curative effect was statistically evaluated by the united states institute of rheumatology acr@ , acr@ , and acr@ improvement criteria .", "meanwhile , any adverse event was recorded and evaluated .", "totally @ completed the trial , and @ dropped off ( @ in the treatment group and @ in the control group ) .", "compared with the control group , there was no statistical difference in acr@ , acr@ , or acr@ in the treatment group ( p > @ ) .", "compared with before treatment in the same group , there was some improvement in tender joint number , swollen joint number , visual analogue scale ( vas ) for patients ' global assessment , vas for physicians ' global assessment , esr , crp , and haq between the two groups , showing statistical difference ( p < @ ) .", "compared with the control group in the same phase , there was no statistical difference in the treatment group ( p > @ ) .", "there was no statistical difference in the occurrence of adverse events between the two groups .", "etanercept plus twp could achieve equivalent therapeutic effect to that of etanercept plus mtx .", "the two regimens could improve clinical signs , symptoms , and qol related to ra .", "they were well tolerated in the treatment of elderly patients with active ra ." ]
to evaluate the efficacy and safety of etanercept plus tripterygium wilfordii polyglycoside ( twp ) in elderly patients with active rheumatoid arthritis ( ra ) . totally @ elderly patients with active ra were randomly assigned to the treatment group ( @ cases ) and the control group ( @ cases ) . all patients received subcutaneous injection of etanercept , @ mg each time , twice per week . the dosage was reduced to once per week @ months later . patients in the treatment group took twp tablet ( @ mg each time , three times per day ) , while those in the control group took methotrexate ( mtx ) , @ mg each time , once per week . the whole course lasted for @ weeks . patients ' rest pain , tender joint number , swollen joint number , health assessment questionnaire ( haq ) , patients ' global assessment , physicians ' global assessment , erythrocyte sediment rate ( esr ) , c reactive protein ( crp ) , rheumatic factor were assessed at week @ , @ , @ , @ , and @ . the curative effect was statistically evaluated by the united states institute of rheumatology acr@ , acr@ , and acr@ improvement criteria . meanwhile , any adverse event was recorded and evaluated . totally @ completed the trial , and @ dropped off ( @ in the treatment group and @ in the control group ) . compared with the control group , there was no statistical difference in acr@ , acr@ , or acr@ in the treatment group ( p > @ ) . compared with before treatment in the same group , there was some improvement in tender joint number , swollen joint number , visual analogue scale ( vas ) for patients ' global assessment , vas for physicians ' global assessment , esr , crp , and haq between the two groups , showing statistical difference ( p < @ ) . compared with the control group in the same phase , there was no statistical difference in the treatment group ( p > @ ) . there was no statistical difference in the occurrence of adverse events between the two groups . etanercept plus twp could achieve equivalent therapeutic effect to that of etanercept plus mtx . the two regimens could improve clinical signs , symptoms , and qol related to ra . they were well tolerated in the treatment of elderly patients with active ra .
24,758,073
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "proficiency and self-confidence in the physical examination is poor among internal medicine residents and interest in ultrasound technology has expanded .", "we aimed to determine whether a pocket-sized ultrasound improves the diagnostic accuracy and confidence of residents after a @-h training session and @ month of independent practice .", "this was a randomized parallel group controlled trial .", "forty internal medicine residents in a single program at an academic medical center participated in the study .", "three hours of training on use of pocket-sized ultrasound was followed by @ month of independent practice .", "the primary outcome was a comparison of the diagnostic accuracy of a physical exam alone versus a physical examination augmented with a pocket-sized ultrasound .", "other outcomes included confidence in exam findings and a survey of attitudes towards the physical exam and the role of ultrasound .", "residents in the intervention group using a pocket-sized ultrasound correctly identified an average of @ of the @ abnormal findings ( accuracy rate of @ % ) .", "those in the control group correctly identified an average of @ abnormal findings ( accuracy rate of @ % , p = @ ) .", "residents in the intervention group identified on average @ findings as abnormal when no abnormality existed ( false positive rate of @ % ) .", "those in the control group incorrectly identified an average of @ positive findings ( false positive rate of @ % ) .", "there was no difference between groups regarding self-assessed confidence in physical examination .", "residents in the intervention group identified @ of @ abnormal cardiac findings versus the control group 's @ of @ , an accuracy rate of @ % versus @ % ( p = @ ) .", "the diagnostic ability of internal medicine residents did not significantly improve with use of a pocket-sized ultrasound device after a @-h training session and @ month of independent practice .", "clinicaltrials.gov : number nct@ ; url http://clinicaltrials.gov/ct@/show/study/nct@?term=ultrasound+physical+exam&rank=@ ." ]
proficiency and self-confidence in the physical examination is poor among internal medicine residents and interest in ultrasound technology has expanded . we aimed to determine whether a pocket-sized ultrasound improves the diagnostic accuracy and confidence of residents after a @-h training session and @ month of independent practice . this was a randomized parallel group controlled trial . forty internal medicine residents in a single program at an academic medical center participated in the study . three hours of training on use of pocket-sized ultrasound was followed by @ month of independent practice . the primary outcome was a comparison of the diagnostic accuracy of a physical exam alone versus a physical examination augmented with a pocket-sized ultrasound . other outcomes included confidence in exam findings and a survey of attitudes towards the physical exam and the role of ultrasound . residents in the intervention group using a pocket-sized ultrasound correctly identified an average of @ of the @ abnormal findings ( accuracy rate of @ % ) . those in the control group correctly identified an average of @ abnormal findings ( accuracy rate of @ % , p = @ ) . residents in the intervention group identified on average @ findings as abnormal when no abnormality existed ( false positive rate of @ % ) . those in the control group incorrectly identified an average of @ positive findings ( false positive rate of @ % ) . there was no difference between groups regarding self-assessed confidence in physical examination . residents in the intervention group identified @ of @ abnormal cardiac findings versus the control group 's @ of @ , an accuracy rate of @ % versus @ % ( p = @ ) . the diagnostic ability of internal medicine residents did not significantly improve with use of a pocket-sized ultrasound device after a @-h training session and @ month of independent practice . clinicaltrials.gov : number nct@ ; url http://clinicaltrials.gov/ct@/show/study/nct@?term=ultrasound+physical+exam&rank=@ .
25,387,438
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]
[ "to evaluate whether using long-axis or short-axis view during ultrasound-guided internal jugular and subclavian central venous catheterization results in fewer skin breaks , decreased time to cannulation , and fewer posterior wall penetrations .", "prospective , randomized crossover study .", "urban emergency department with approximate annual census of @,@ .", "emergency medicine resident physicians at the denver health residency in emergency medicine , a postgraduate year @-@ training program .", "resident physicians blinded to the study hypothesis used ultrasound guidance to cannulate the internal jugular and subclavian of a human torso mannequin using the long-axis and short-axis views at each site .", "an ultrasound fellow recorded skin breaks , redirections , and time to cannulation .", "an experienced ultrasound fellow or attending used a convex @-@ mhz transducer during cannulation to monitor the needle path and determine posterior wall penetration .", "generalized linear mixed models with a random subject effect were used to compare time to cannulation , number of skin breaks and redirections , and posterior wall penetration of the long axis and short axis at each cannulation site .", "twenty-eight resident physicians participated : eight postgraduate year @ , eight postgraduate year @ , five postgraduate year @ , and seven postgraduate year @ .", "the median ( interquartile range ) number of total internal jugular central venous catheters placed was @ ( interquartile range , @-@ ) and subclavian was six catheters ( interquartile range , @-@ ) .", "the median number of previous ultrasound-guided internal jugular catheters was @ ( interquartile range , @-@ ) , and ultrasound-guided subclavian catheters were three ( interquartile range , @-@ ) .", "the long-axis view was associated with a significant decrease in the number of redirections at the internal jugular and subclavian sites , relative risk @ ( @ % ci , @-@ @ ) and relative risk @ ( @ % ci , @-@ @ ) , respectively .", "there was no significant difference in the number of skin breaks between the long axis and short axis at the subclavian and internal jugular sites .", "the long-axis view for subclavian was associated with decreased time to cannulation ; there was no significant difference in time between the short-axis and long-axis views at the internal jugular site .", "the prevalence of posterior wall penetration was internal jugular short axis @ % , internal jugular long axis @ % , subclavian short axis @ % , and subclavian long axis @ % .", "the odds of posterior wall penetration were significantly less in the subclavian long axis ( odds ratio , @ ; @ % ci , @-@ @ ) .", "the long-axis view for the internal jugular was more efficient than the short-axis view with fewer redirections .", "the long-axis view for subclavian central venous catheterization was also more efficient with decreased time to cannulation and fewer redirections .", "the long-axis approach to subclavian central venous catheterization is also associated with fewer posterior wall penetrations .", "using the long-axis view for subclavian central venous catheterization and avoiding posterior wall penetrations may result in fewer central venous catheter-related complications ." ]
to evaluate whether using long-axis or short-axis view during ultrasound-guided internal jugular and subclavian central venous catheterization results in fewer skin breaks , decreased time to cannulation , and fewer posterior wall penetrations . prospective , randomized crossover study . urban emergency department with approximate annual census of @,@ . emergency medicine resident physicians at the denver health residency in emergency medicine , a postgraduate year @-@ training program . resident physicians blinded to the study hypothesis used ultrasound guidance to cannulate the internal jugular and subclavian of a human torso mannequin using the long-axis and short-axis views at each site . an ultrasound fellow recorded skin breaks , redirections , and time to cannulation . an experienced ultrasound fellow or attending used a convex @-@ mhz transducer during cannulation to monitor the needle path and determine posterior wall penetration . generalized linear mixed models with a random subject effect were used to compare time to cannulation , number of skin breaks and redirections , and posterior wall penetration of the long axis and short axis at each cannulation site . twenty-eight resident physicians participated : eight postgraduate year @ , eight postgraduate year @ , five postgraduate year @ , and seven postgraduate year @ . the median ( interquartile range ) number of total internal jugular central venous catheters placed was @ ( interquartile range , @-@ ) and subclavian was six catheters ( interquartile range , @-@ ) . the median number of previous ultrasound-guided internal jugular catheters was @ ( interquartile range , @-@ ) , and ultrasound-guided subclavian catheters were three ( interquartile range , @-@ ) . the long-axis view was associated with a significant decrease in the number of redirections at the internal jugular and subclavian sites , relative risk @ ( @ % ci , @-@ @ ) and relative risk @ ( @ % ci , @-@ @ ) , respectively . there was no significant difference in the number of skin breaks between the long axis and short axis at the subclavian and internal jugular sites . the long-axis view for subclavian was associated with decreased time to cannulation ; there was no significant difference in time between the short-axis and long-axis views at the internal jugular site . the prevalence of posterior wall penetration was internal jugular short axis @ % , internal jugular long axis @ % , subclavian short axis @ % , and subclavian long axis @ % . the odds of posterior wall penetration were significantly less in the subclavian long axis ( odds ratio , @ ; @ % ci , @-@ @ ) . the long-axis view for the internal jugular was more efficient than the short-axis view with fewer redirections . the long-axis view for subclavian central venous catheterization was also more efficient with decreased time to cannulation and fewer redirections . the long-axis approach to subclavian central venous catheterization is also associated with fewer posterior wall penetrations . using the long-axis view for subclavian central venous catheterization and avoiding posterior wall penetrations may result in fewer central venous catheter-related complications .
25,517,477
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "igf-i is thought to mediate many of the anabolic actions of gh , and there are anecdotal reports that igf-i is misused by elite athletes .", "there is no published evidence regarding the effects of igf-i administration on athletic performance .", "the objective of the study was to investigate the effects of igf-i administration on body composition and physical fitness in recreational athletes .", "this was a randomized , double-blind , placebo-controlled recombinant human ( rh ) igf-i/rhigf binding protein ( igfbp ) -@ administration study at southampton general hospital ( southampton , united kingdom ) .", "fifty-six recreational athletes ( @ men , @ women ) participated in the study .", "participants were randomly assigned to receive placebo , low-dose rhigf-i/rhigfbp -@ ( @ mg/d ) , or high dose rhigf-i/rhigfbp -@ ( @ mg/d ) for @ days .", "body composition ( assessed by dual energy x-ray absorptiometry ) and cardiorespiratory fitness ( assessed by incremental treadmill test ) were measured before and immediately after treatment .", "within-individual changes after treatment were analyzed using paired t tests .", "there were no significant changes in body fat mass or lean body mass in women or men after the administration of the rhigf-i/rhigfbp -@ complex .", "there was a significant increase in maximal oxygen consumption ( vo@ max ) after treatment .", "when women and men and low - and high-dose treatment groups were combined , mean vo@ max increased by approximately @ % ( p = @ ) .", "no significant change in vo@ max was observed in the placebo group .", "rhigf-i/rhigfbp -@ administration for @ days improves aerobic performance in recreational athletes , but there are no effects on body composition ." ]
igf-i is thought to mediate many of the anabolic actions of gh , and there are anecdotal reports that igf-i is misused by elite athletes . there is no published evidence regarding the effects of igf-i administration on athletic performance . the objective of the study was to investigate the effects of igf-i administration on body composition and physical fitness in recreational athletes . this was a randomized , double-blind , placebo-controlled recombinant human ( rh ) igf-i/rhigf binding protein ( igfbp ) -@ administration study at southampton general hospital ( southampton , united kingdom ) . fifty-six recreational athletes ( @ men , @ women ) participated in the study . participants were randomly assigned to receive placebo , low-dose rhigf-i/rhigfbp -@ ( @ mg/d ) , or high dose rhigf-i/rhigfbp -@ ( @ mg/d ) for @ days . body composition ( assessed by dual energy x-ray absorptiometry ) and cardiorespiratory fitness ( assessed by incremental treadmill test ) were measured before and immediately after treatment . within-individual changes after treatment were analyzed using paired t tests . there were no significant changes in body fat mass or lean body mass in women or men after the administration of the rhigf-i/rhigfbp -@ complex . there was a significant increase in maximal oxygen consumption ( vo@ max ) after treatment . when women and men and low - and high-dose treatment groups were combined , mean vo@ max increased by approximately @ % ( p = @ ) . no significant change in vo@ max was observed in the placebo group . rhigf-i/rhigfbp -@ administration for @ days improves aerobic performance in recreational athletes , but there are no effects on body composition .
26,046,967
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to compare the effectiveness of conventional and game-based oral health education on the oral health-related knowledge and oral hygiene status among @ - to @-year-old schoolchildren .", "a total of @ children aged @ to @ years were divided into @ groups .", "each group had @ children aged @ to @ years and @ children aged @ to @ years .", "a pretest evaluation of their knowledge regarding oral health and the estimation of debris index-simplified ( di-s ) was carried out .", "children in group a were given oral health education through flash cards once daily for @ days .", "children in group b were educated through the play method ( i.e. snakes and ladders game combined with flash cards ) .", "the evaluations regarding oral hygiene and di-s were recorded on post-intervention day @ and @ months after the intervention .", "in group b , high knowledge scores of @ and @ were obtained by the @ - to @-year-olds and @ - to @-yearolds , respectively , on post-intervention day @ .", "the lowest mean percentage difference of @ was seen in @ - to @-yearold children of group a after @ months .", "in group b ( @-@ and @-@ ) and group a ( @-@ ) there was a significant increase in good oral hygiene scores and a significant decrease in fair and poor debris scores on post-intervention day @ and at the @-month follow-up .", "the knowledge scores of both the younger and older groups of children increased considerably when the game-based teaching intervention was used .", "hence , it can be an effective aid for teaching basic oral health concepts to children ." ]
to compare the effectiveness of conventional and game-based oral health education on the oral health-related knowledge and oral hygiene status among @ - to @-year-old schoolchildren . a total of @ children aged @ to @ years were divided into @ groups . each group had @ children aged @ to @ years and @ children aged @ to @ years . a pretest evaluation of their knowledge regarding oral health and the estimation of debris index-simplified ( di-s ) was carried out . children in group a were given oral health education through flash cards once daily for @ days . children in group b were educated through the play method ( i.e. snakes and ladders game combined with flash cards ) . the evaluations regarding oral hygiene and di-s were recorded on post-intervention day @ and @ months after the intervention . in group b , high knowledge scores of @ and @ were obtained by the @ - to @-year-olds and @ - to @-yearolds , respectively , on post-intervention day @ . the lowest mean percentage difference of @ was seen in @ - to @-yearold children of group a after @ months . in group b ( @-@ and @-@ ) and group a ( @-@ ) there was a significant increase in good oral hygiene scores and a significant decrease in fair and poor debris scores on post-intervention day @ and at the @-month follow-up . the knowledge scores of both the younger and older groups of children increased considerably when the game-based teaching intervention was used . hence , it can be an effective aid for teaching basic oral health concepts to children .
25,197,737
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "this single-center , randomized , clinical trial was designed to determine the @-year comparative efficacy and durability of carotid angioplasty and stenting ( cas ) versus carotid endarterectomy ( cea ) in preventing ipsilateral ischemic stroke in symptomatic and asymptomatic patients with high-grade carotid artery stenosis .", "modern clinical trials with short-term follow-up indicate cas and cea are equivalent in reducing the risk for ipsilateral ischemic stroke secondary to carotid stenosis .", "a paucity of data exists regarding long-term outcomes .", "patients of all surgical risks with symptomatic and asymptomatic carotid stenosis ( > @ % ) were randomly selected for cea or cas and followed a minimum of @ years .", "long-term follow-up was achieved in @ patients ( @ % ) .", "eighty-seven ( @ % ) died within this period , most commonly of nonvascular causes .", "no difference in the risk of stroke ipsilateral to the treated artery was noted among treatment groups ( p > @ ) .", "restenosis determined by sequential ultrasound was assessed only in the cas group ( @ % ) and remained asymptomatic .", "the combined risk of fatal or nonfatal heart attack over the @-year period was highest in individuals with symptomatic versus asymptomatic stenosis ( @ % vs. @ % ; hazard ratio -lsb- hr -rsb- : @ , @ % confidence interval -lsb- ci -rsb- : @ to @ , p = @ ) and was higher in all patients treated with cea ( hr : @ , @ % ci : @ to @ , p = @ ) .", "long-term protection against ipsilateral stroke provided by cas and cea did not differ in this trial .", "the @-year risk of fatal/nonfatal myocardial infarction was highest in all patients harboring symptomatic carotid stenosis at enrollment .", "the risk of fatal/nonfatal heart attack was significantly more prevalent in those symptomatic or asymptomatic patients randomized to cea ." ]
this single-center , randomized , clinical trial was designed to determine the @-year comparative efficacy and durability of carotid angioplasty and stenting ( cas ) versus carotid endarterectomy ( cea ) in preventing ipsilateral ischemic stroke in symptomatic and asymptomatic patients with high-grade carotid artery stenosis . modern clinical trials with short-term follow-up indicate cas and cea are equivalent in reducing the risk for ipsilateral ischemic stroke secondary to carotid stenosis . a paucity of data exists regarding long-term outcomes . patients of all surgical risks with symptomatic and asymptomatic carotid stenosis ( > @ % ) were randomly selected for cea or cas and followed a minimum of @ years . long-term follow-up was achieved in @ patients ( @ % ) . eighty-seven ( @ % ) died within this period , most commonly of nonvascular causes . no difference in the risk of stroke ipsilateral to the treated artery was noted among treatment groups ( p > @ ) . restenosis determined by sequential ultrasound was assessed only in the cas group ( @ % ) and remained asymptomatic . the combined risk of fatal or nonfatal heart attack over the @-year period was highest in individuals with symptomatic versus asymptomatic stenosis ( @ % vs. @ % ; hazard ratio -lsb- hr -rsb- : @ , @ % confidence interval -lsb- ci -rsb- : @ to @ , p = @ ) and was higher in all patients treated with cea ( hr : @ , @ % ci : @ to @ , p = @ ) . long-term protection against ipsilateral stroke provided by cas and cea did not differ in this trial . the @-year risk of fatal/nonfatal myocardial infarction was highest in all patients harboring symptomatic carotid stenosis at enrollment . the risk of fatal/nonfatal heart attack was significantly more prevalent in those symptomatic or asymptomatic patients randomized to cea .
24,556,095
[ "OBJECTIVE", "BACKGROUND", "BACKGROUND", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "reductions in drinking among individuals randomised to control groups in brief alcohol intervention trials are common and suggest that asking study participants about their drinking may itself cause them to reduce their consumption .", "we sought to test the hypothesis that the statistical artefact regression to the mean ( rtm ) explains part of the reduction in such studies .", "@ participants in a cohort study of alcohol consumption in new zealand provided data at baseline and again six months later .", "we use graphical methods and apply thresholds of @ , @ , @ and @ in audit scores to explore rtm .", "there was a negative association between baseline audit scores and change in audit scores from baseline to six months , which in the absence of bias and confounding , is rtm .", "students with lower baseline scores tended to have higher follow-up scores and conversely , those with higher baseline scores tended to have lower follow-up scores .", "when a threshold score of @ was used to select a subgroup , the observed mean change was approximately half of that observed without a threshold .", "the application of higher thresholds produced greater apparent reductions in alcohol consumption .", "part of the reduction seen in the control groups of brief alcohol intervention trials is likely to be due to rtm and the amount of change is likely to be greater as the threshold for entry to the trial increases .", "quantification of rtm warrants further study and should assist understanding assessment and other research participation effects ." ]
reductions in drinking among individuals randomised to control groups in brief alcohol intervention trials are common and suggest that asking study participants about their drinking may itself cause them to reduce their consumption . we sought to test the hypothesis that the statistical artefact regression to the mean ( rtm ) explains part of the reduction in such studies . @ participants in a cohort study of alcohol consumption in new zealand provided data at baseline and again six months later . we use graphical methods and apply thresholds of @ , @ , @ and @ in audit scores to explore rtm . there was a negative association between baseline audit scores and change in audit scores from baseline to six months , which in the absence of bias and confounding , is rtm . students with lower baseline scores tended to have higher follow-up scores and conversely , those with higher baseline scores tended to have lower follow-up scores . when a threshold score of @ was used to select a subgroup , the observed mean change was approximately half of that observed without a threshold . the application of higher thresholds produced greater apparent reductions in alcohol consumption . part of the reduction seen in the control groups of brief alcohol intervention trials is likely to be due to rtm and the amount of change is likely to be greater as the threshold for entry to the trial increases . quantification of rtm warrants further study and should assist understanding assessment and other research participation effects .
24,342,421
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "clinical trials are increasingly being conducted as new products seek to enter the market .", "deployment of such interventions is based on evidence obtained mainly from the gold standard of randomized controlled clinical trials ( rcct ) .", "a crucial factor in the ability of rccts to provide credible and generalisable data is sample size and retention of the required number of subjects at completion of the follow-up period .", "however , recruitment and retention in clinical trials are hindered by prevalent peculiar challenges in africa that need to be circumvented .", "this article shares experiences from a phase ii trial that recorded a high retention rate at @ months follow-up at a new clinical trial site .", "mothers bringing children less than two months of age to the health facility were given information and invited to have their child enrolled if the inclusion criteria were fulfilled .", "participants were enrolled over @ months .", "trial procedures , duration and risks/benefits were painstakingly and sequentially explained to the communities , parents and relevant relatives before and during the trial period .", "the proportions of participants that completed or did not complete the trial were analyzed including the reasons for failure to complete all trial procedures .", "@ individuals received information regarding the trial of which @ returned for screening .", "@ ( @ % ) of them who fulfilled the inclusion criteria and did not meet any exclusion criteria were enrolled and @ % of these completed the trial .", "consent withdrawal was the main reason for not completing the trial largely ( @ % ) due to the father not being involved at the point of consenting or parents no longer being comfortable with blood sampling .", "participant retention in clinical trials remains a crucial factor in ensuring generalisability of trial data .", "appropriate measures to enhance retention should include continuous community involvement in the process , adequate explanation of trial procedures and risks/benefits ; and innovative tracing of participants adapted for the setting ." ]
clinical trials are increasingly being conducted as new products seek to enter the market . deployment of such interventions is based on evidence obtained mainly from the gold standard of randomized controlled clinical trials ( rcct ) . a crucial factor in the ability of rccts to provide credible and generalisable data is sample size and retention of the required number of subjects at completion of the follow-up period . however , recruitment and retention in clinical trials are hindered by prevalent peculiar challenges in africa that need to be circumvented . this article shares experiences from a phase ii trial that recorded a high retention rate at @ months follow-up at a new clinical trial site . mothers bringing children less than two months of age to the health facility were given information and invited to have their child enrolled if the inclusion criteria were fulfilled . participants were enrolled over @ months . trial procedures , duration and risks/benefits were painstakingly and sequentially explained to the communities , parents and relevant relatives before and during the trial period . the proportions of participants that completed or did not complete the trial were analyzed including the reasons for failure to complete all trial procedures . @ individuals received information regarding the trial of which @ returned for screening . @ ( @ % ) of them who fulfilled the inclusion criteria and did not meet any exclusion criteria were enrolled and @ % of these completed the trial . consent withdrawal was the main reason for not completing the trial largely ( @ % ) due to the father not being involved at the point of consenting or parents no longer being comfortable with blood sampling . participant retention in clinical trials remains a crucial factor in ensuring generalisability of trial data . appropriate measures to enhance retention should include continuous community involvement in the process , adequate explanation of trial procedures and risks/benefits ; and innovative tracing of participants adapted for the setting .
25,298,043
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "symptomatic hip osteoarthritis ( oa ) is a disabling condition with up to a @ % cumulative lifetime risk .", "total hip arthroplasty ( tha ) is effective in relieving patients ' symptoms and improving function .", "it is , however , associated with substantial risk of complications , pain and major functional limitation before patients can return to full function .", "in contrast , hip arthroscopy ( ha ) is less invasive and can postpone tha .", "however , there is no evidence regarding the delay in the need for tha that patients would find acceptable to undergoing ha .", "knowing patients ' values and preferences ( vp ) on this expected delay is critical when making recommendations regarding the advisability of ha .", "furthermore , little is known on the optimal amount of information regarding interventions and outcomes needed to present in order to optimally elicit patients ' vp .", "we will perform a multinational , structured interview-based survey of preference in delay time for tha among patients with non-advanced oa who failed to respond to conservative therapy .", "we will combine these interviews with a randomised trial addressing the optimal amount of information regarding the interventions and outcomes required to elicit preferences .", "eligible patients will be randomly assigned ( @:@ ) to either a short or a long format of health scenarios of tha and ha .", "we will determine each patient 's vp using a trade-off and anticipated regret exercises .", "our primary outcomes for the combined surveys will be : ( @ ) the minimal delay time in the need for tha surgery that patients would find acceptable to undertaking ha , ( @ ) patients ' satisfaction with the amount of information provided in the health scenarios used to elicit their vps .", "the protocol has been approved by the hamilton integrated research ethics board ( hireb@-@ ) .", "we will disseminate our study findings through peer-reviewed publications and conference presentations , and make them available to guideline makers issuing recommendations addressing ha and tha ." ]
symptomatic hip osteoarthritis ( oa ) is a disabling condition with up to a @ % cumulative lifetime risk . total hip arthroplasty ( tha ) is effective in relieving patients ' symptoms and improving function . it is , however , associated with substantial risk of complications , pain and major functional limitation before patients can return to full function . in contrast , hip arthroscopy ( ha ) is less invasive and can postpone tha . however , there is no evidence regarding the delay in the need for tha that patients would find acceptable to undergoing ha . knowing patients ' values and preferences ( vp ) on this expected delay is critical when making recommendations regarding the advisability of ha . furthermore , little is known on the optimal amount of information regarding interventions and outcomes needed to present in order to optimally elicit patients ' vp . we will perform a multinational , structured interview-based survey of preference in delay time for tha among patients with non-advanced oa who failed to respond to conservative therapy . we will combine these interviews with a randomised trial addressing the optimal amount of information regarding the interventions and outcomes required to elicit preferences . eligible patients will be randomly assigned ( @:@ ) to either a short or a long format of health scenarios of tha and ha . we will determine each patient 's vp using a trade-off and anticipated regret exercises . our primary outcomes for the combined surveys will be : ( @ ) the minimal delay time in the need for tha surgery that patients would find acceptable to undertaking ha , ( @ ) patients ' satisfaction with the amount of information provided in the health scenarios used to elicit their vps . the protocol has been approved by the hamilton integrated research ethics board ( hireb@-@ ) . we will disseminate our study findings through peer-reviewed publications and conference presentations , and make them available to guideline makers issuing recommendations addressing ha and tha .
25,326,208
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "BACKGROUND", "BACKGROUND" ]
[ "from @ to @ , the annual incidence of inpatient treatment for distal radius fracture in germany rose from @ to @ per @ @ persons .", "it is unclear whether open reduction and volar angle-stable plate osteosynthesis ( orif ) , a currently advocated treatment , yields a better functional outcome or quality of life than closed reposition and casting .", "in the orchid multi-center trial , @ patients aged @ and older with an ao type c distal radial fracture were randomly assigned to orif or closed reposition and casting .", "their health-related quality of life and hand/arm function were assessed @ and @ months afterward with the short form @ ( sf-@ ) questionnaire and the disability of the arm , shoulder and hand ( dash ) questionnaire .", "the radiological findings , range of movement of the wrist , and euroqol-@d ( eq-@d ) scores were documented as well .", "among the @ patients in the intention-to-treat-analysis , there was no significant difference in sf-@ scores between the two treatment groups at one year ( mean difference , @ points in favor of orif ; @ % confidence interval , -@ +@ points ; p = @ ) .", "the dash scores showed moderately strong , but clinically unimportant effects in favor of orif , and there was no difference in eq-@d scores .", "orif led to better radiological results and wrist mobility at @ months , with comparable results at @ months .", "@ of the patients initially allotted to nonsurgical treatment underwent secondary surgery due to significant loss of reduction .", "the findings with respect to mobility , functionality , and quality of life at @ months provide marginal and inconsistent evidence for the superiority of volar angle-stable plate osteosynthesis over closed reduction and casting in the treatment of intra-articular distal radius fractures .", "primary nonsurgical management is also effective in suitable patients ." ]
from @ to @ , the annual incidence of inpatient treatment for distal radius fracture in germany rose from @ to @ per @ @ persons . it is unclear whether open reduction and volar angle-stable plate osteosynthesis ( orif ) , a currently advocated treatment , yields a better functional outcome or quality of life than closed reposition and casting . in the orchid multi-center trial , @ patients aged @ and older with an ao type c distal radial fracture were randomly assigned to orif or closed reposition and casting . their health-related quality of life and hand/arm function were assessed @ and @ months afterward with the short form @ ( sf-@ ) questionnaire and the disability of the arm , shoulder and hand ( dash ) questionnaire . the radiological findings , range of movement of the wrist , and euroqol-@d ( eq-@d ) scores were documented as well . among the @ patients in the intention-to-treat-analysis , there was no significant difference in sf-@ scores between the two treatment groups at one year ( mean difference , @ points in favor of orif ; @ % confidence interval , -@ +@ points ; p = @ ) . the dash scores showed moderately strong , but clinically unimportant effects in favor of orif , and there was no difference in eq-@d scores . orif led to better radiological results and wrist mobility at @ months , with comparable results at @ months . @ of the patients initially allotted to nonsurgical treatment underwent secondary surgery due to significant loss of reduction . the findings with respect to mobility , functionality , and quality of life at @ months provide marginal and inconsistent evidence for the superiority of volar angle-stable plate osteosynthesis over closed reduction and casting in the treatment of intra-articular distal radius fractures . primary nonsurgical management is also effective in suitable patients .
25,491,556
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "secondary acute myeloid leukemia ( saml ) , defined as aml arising after a prior myelodysplastic syndrome or after antineoplastic therapy , responds poorly to current therapies .", "it is often associated with adverse karyotypic abnormalities and overexpression of proteins that mediate drug resistance .", "we performed a phase iii trial to determine whether induction therapy with cytarabine and amonafide l-malate , a dna intercalator and non-atp-dependent topoisomerase ii inhibitor that evades drug resistance mechanisms , yielded a superior complete remission rate than standard therapy with cytarabine and daunorubicin in saml .", "patients with previously untreated saml were randomly assigned at a one-to-one ratio to cytarabine @ mg/m ( @ ) continuous intravenous ( iv ) infusion once per day on days @ to @ plus either amonafide @ mg/m ( @ ) iv over @ hours on days @ to @ ( a + c arm ) or daunorubicin @ mg/m ( @ ) iv over @ minutes once per day on days @ to @ ( d + c arm ) .", "the complete remission ( cr ) rate was @ % ( @ of @ patients ) in a + c arm and @ % ( @ of @ patients ) in d + c arm ( p = @ ) .", "the @ - and @-day mortality rates were @ % and @ % in a + c arm and @ % and @ % in d + c arm , respectively .", "induction treatment with a + c did not improve the cr rate compared with d + c in patients with saml ." ]
secondary acute myeloid leukemia ( saml ) , defined as aml arising after a prior myelodysplastic syndrome or after antineoplastic therapy , responds poorly to current therapies . it is often associated with adverse karyotypic abnormalities and overexpression of proteins that mediate drug resistance . we performed a phase iii trial to determine whether induction therapy with cytarabine and amonafide l-malate , a dna intercalator and non-atp-dependent topoisomerase ii inhibitor that evades drug resistance mechanisms , yielded a superior complete remission rate than standard therapy with cytarabine and daunorubicin in saml . patients with previously untreated saml were randomly assigned at a one-to-one ratio to cytarabine @ mg/m ( @ ) continuous intravenous ( iv ) infusion once per day on days @ to @ plus either amonafide @ mg/m ( @ ) iv over @ hours on days @ to @ ( a + c arm ) or daunorubicin @ mg/m ( @ ) iv over @ minutes once per day on days @ to @ ( d + c arm ) . the complete remission ( cr ) rate was @ % ( @ of @ patients ) in a + c arm and @ % ( @ of @ patients ) in d + c arm ( p = @ ) . the @ - and @-day mortality rates were @ % and @ % in a + c arm and @ % and @ % in d + c arm , respectively . induction treatment with a + c did not improve the cr rate compared with d + c in patients with saml .
25,732,165
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to investigate the clinical efficacy of three toothpastes in controlling established gingivitis and plaque over @ months .", "@ subjects were enrolled in a single-center , double-blind , parallel group , randomized clinical study .", "subjects were randomly assigned to one of three treatments : triclosan/copolymer/fluoride dentifrice containing @ % triclosan , @ % copolymer and @,@ ppm f as sodium fluoride in a silica base ; herbal/bicarbonate dentifrice containing herbal extract and @,@ ppm f as sodium fluoride in a sodium bicarbonate base ; or fluoride dentifrice containing @ ppm f as sodium fluoride , and @,@ ppm f as sodium monofluorophosphate .", "subjects were instructed to brush their teeth twice daily for @ minute for @ months .", "after @ months , subjects assigned to the triclosan/copolymer/fluoride group exhibited statistically significant reductions in gingival index scores and plaque index scores as compared to subjects assigned to the herbal/bicarbonate group by @ % and @ % , respectively .", "there were no statistically significant differences in gingival index and plaque index between subjects in the herbal / bicarbonate group and those in the fluoride group .", "the triclosan/copolymer/fluoride dentifrice was statistically significantly more effective in reducing gingivitis and dental plaque than the herbal/bicarbonate dentifrice , and this difference in efficacy was clinically meaningful ." ]
to investigate the clinical efficacy of three toothpastes in controlling established gingivitis and plaque over @ months . @ subjects were enrolled in a single-center , double-blind , parallel group , randomized clinical study . subjects were randomly assigned to one of three treatments : triclosan/copolymer/fluoride dentifrice containing @ % triclosan , @ % copolymer and @,@ ppm f as sodium fluoride in a silica base ; herbal/bicarbonate dentifrice containing herbal extract and @,@ ppm f as sodium fluoride in a sodium bicarbonate base ; or fluoride dentifrice containing @ ppm f as sodium fluoride , and @,@ ppm f as sodium monofluorophosphate . subjects were instructed to brush their teeth twice daily for @ minute for @ months . after @ months , subjects assigned to the triclosan/copolymer/fluoride group exhibited statistically significant reductions in gingival index scores and plaque index scores as compared to subjects assigned to the herbal/bicarbonate group by @ % and @ % , respectively . there were no statistically significant differences in gingival index and plaque index between subjects in the herbal / bicarbonate group and those in the fluoride group . the triclosan/copolymer/fluoride dentifrice was statistically significantly more effective in reducing gingivitis and dental plaque than the herbal/bicarbonate dentifrice , and this difference in efficacy was clinically meaningful .
26,087,570
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS" ]
[ "although asthma is characterized by variable airways obstruction , most studies of asthma phenotypes are cross-sectional .", "the stability of phenotypes defined either by biomarkers or by physiological variables was assessed by repeated measures over @year in the pan-european bioair cohort of adult asthmatics .", "a total of @ patients , @ with severe asthma ( sa ) and @ with mild-to-moderate asthma ( ma ) , were examined at six or more visits during @year .", "asthma phenotype clusters were defined by physiological variables ( lung function , reversibility and age of onset of the disease ) or by biomarkers ( eosinophils and neutrophils in induced sputum ) .", "after @year of follow-up , the allocation to clusters was changed in @ % of all asthma patients when defined by physiological phenotypes and , remarkably , in @ % of the patients when stratified according to sputum cellularity ( p = @ ) .", "in the sa cohort , @ % and @ % of the patients changed allocation according to physiological and biomarker clustering , respectively .", "variability of phenotypes was not influenced by change in oral or inhaled corticosteroid dose , nor by the number of exacerbations .", "lower stability of single and repeated measure was found for all evaluated biomarkers ( eosinophils , neutrophils and feno ) in contrast to good stability of physiological variables ( fev@ ) , quality of life and asthma control .", "phenotypes determined by biomarkers are less stable than those defined by physiological variables , especially in severe asthmatics .", "the data also imply that definition of asthma phenotypes is improved by repeated measures to account for fluctuations in lung function , biomarkers and asthma control ." ]
although asthma is characterized by variable airways obstruction , most studies of asthma phenotypes are cross-sectional . the stability of phenotypes defined either by biomarkers or by physiological variables was assessed by repeated measures over @year in the pan-european bioair cohort of adult asthmatics . a total of @ patients , @ with severe asthma ( sa ) and @ with mild-to-moderate asthma ( ma ) , were examined at six or more visits during @year . asthma phenotype clusters were defined by physiological variables ( lung function , reversibility and age of onset of the disease ) or by biomarkers ( eosinophils and neutrophils in induced sputum ) . after @year of follow-up , the allocation to clusters was changed in @ % of all asthma patients when defined by physiological phenotypes and , remarkably , in @ % of the patients when stratified according to sputum cellularity ( p = @ ) . in the sa cohort , @ % and @ % of the patients changed allocation according to physiological and biomarker clustering , respectively . variability of phenotypes was not influenced by change in oral or inhaled corticosteroid dose , nor by the number of exacerbations . lower stability of single and repeated measure was found for all evaluated biomarkers ( eosinophils , neutrophils and feno ) in contrast to good stability of physiological variables ( fev@ ) , quality of life and asthma control . phenotypes determined by biomarkers are less stable than those defined by physiological variables , especially in severe asthmatics . the data also imply that definition of asthma phenotypes is improved by repeated measures to account for fluctuations in lung function , biomarkers and asthma control .
25,039,610
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]