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[ "major depressive disorder ( mdd ) is a prevalent and severe disorder .", "although effective treatments for mdd are available , many patients remain untreated , mainly because of insufficient treatment capacities in the health care system .", "resulting waiting periods are often associated with prolonged suffering and impairment as well as a higher risk of chronification .", "web-based interventions may help to alleviate these problems .", "numerous studies provided evidence for the efficacy of web-based interventions for depression .", "the aim of this study is to evaluate a new web-based guided self-help intervention ( get.on-mood enhancer-wl ) specifically developed for patients waiting to commence inpatient therapy for mdd .", "in a two-armed randomised controlled trial ( n = @ ) , the web-based guided intervention get.on-mood enhancer-wl in addition to treatment as usual ( tau ) will be compared with tau alone .", "the intervention contains six modules ( psycho education , behavioural activation i & ii , problem solving i & ii , and preparation for subsequent inpatient depression therapy ) .", "the participants will be supported by an e-coach , who will provide written feedback after each module .", "inclusion criteria include a diagnosis of mdd assessed with a structured clinical interview -lsb- scid -rsb- and a waiting period of at least three weeks before start of inpatient treatment .", "the primary outcome is observer-rated depressive symptom severity ( hrsd@ ) .", "further ( explorative ) questions include whether remission will be achieved earlier and by more patients during inpatient therapy because of the web-based preparatory intervention .", "if get.on-mood enhancer-wl is proven to be effective , patients may start inpatient therapy with reduced depressive symptom severity , ideally leading to higher remission rates , shortened inpatient therapy , reduced costs , and decreased waiting times .", "german clinical trial registration ( drks ) : drks@ ." ]
major depressive disorder ( mdd ) is a prevalent and severe disorder . although effective treatments for mdd are available , many patients remain untreated , mainly because of insufficient treatment capacities in the health care system . resulting waiting periods are often associated with prolonged suffering and impairment as well as a higher risk of chronification . web-based interventions may help to alleviate these problems . numerous studies provided evidence for the efficacy of web-based interventions for depression . the aim of this study is to evaluate a new web-based guided self-help intervention ( get.on-mood enhancer-wl ) specifically developed for patients waiting to commence inpatient therapy for mdd . in a two-armed randomised controlled trial ( n = @ ) , the web-based guided intervention get.on-mood enhancer-wl in addition to treatment as usual ( tau ) will be compared with tau alone . the intervention contains six modules ( psycho education , behavioural activation i & ii , problem solving i & ii , and preparation for subsequent inpatient depression therapy ) . the participants will be supported by an e-coach , who will provide written feedback after each module . inclusion criteria include a diagnosis of mdd assessed with a structured clinical interview -lsb- scid -rsb- and a waiting period of at least three weeks before start of inpatient treatment . the primary outcome is observer-rated depressive symptom severity ( hrsd@ ) . further ( explorative ) questions include whether remission will be achieved earlier and by more patients during inpatient therapy because of the web-based preparatory intervention . if get.on-mood enhancer-wl is proven to be effective , patients may start inpatient therapy with reduced depressive symptom severity , ideally leading to higher remission rates , shortened inpatient therapy , reduced costs , and decreased waiting times . german clinical trial registration ( drks ) : drks@ .
24,279,841
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "BACKGROUND" ]
[ "development of obesity after heart transplantation ( ht ) is a common complication , largely attributed to immunosuppressive therapy .", "the objective of this study is to compare the incidence of development of obesity after ht , according to the calcineurin inhibitor ( cni ) used ( cyclosporine -lsb- csa -rsb- vs tacrolimus -lsb- tac -rsb- ) .", "we studied @ consecutive ht patients from november @ to december @ .", "a diagnosis of overweight-obesity was made by a body mass index of @ kg/m ( @ ) , which was assessed before ht and at @ year after ht .", "patients were randomly assigned to the administration of csa or tac by a simple randomization method using a computer program ( @ % received csa and @ % tac ) .", "of the @ patients , @ % were men , and ischemic heart disease was the most common indication for ht .", "at baseline , there were no differences in weight between groups treated with csa or tac .", "the mean weight for each group was @ @ and @ @ kg , respectively ( p = @ ) .", "the weight increase was greater among csa patients : after ht , the weight gain was @ @ kg in the csa group , whereas a minimal weight loss of @ @ kg ( p = @ ) was experienced in the group treated with tac .", "the multivariate analysis showed that only csa treatment was an independent predictor of development of obesity @ year after ht ( odds ratio , @ ; @ % ci , @-@ @ ; p = @ ) .", "weight gain after ht may be related to the cni used and csa seems to be the cni that produces the greatest increase ." ]
development of obesity after heart transplantation ( ht ) is a common complication , largely attributed to immunosuppressive therapy . the objective of this study is to compare the incidence of development of obesity after ht , according to the calcineurin inhibitor ( cni ) used ( cyclosporine -lsb- csa -rsb- vs tacrolimus -lsb- tac -rsb- ) . we studied @ consecutive ht patients from november @ to december @ . a diagnosis of overweight-obesity was made by a body mass index of @ kg/m ( @ ) , which was assessed before ht and at @ year after ht . patients were randomly assigned to the administration of csa or tac by a simple randomization method using a computer program ( @ % received csa and @ % tac ) . of the @ patients , @ % were men , and ischemic heart disease was the most common indication for ht . at baseline , there were no differences in weight between groups treated with csa or tac . the mean weight for each group was @ @ and @ @ kg , respectively ( p = @ ) . the weight increase was greater among csa patients : after ht , the weight gain was @ @ kg in the csa group , whereas a minimal weight loss of @ @ kg ( p = @ ) was experienced in the group treated with tac . the multivariate analysis showed that only csa treatment was an independent predictor of development of obesity @ year after ht ( odds ratio , @ ; @ % ci , @-@ @ ; p = @ ) . weight gain after ht may be related to the cni used and csa seems to be the cni that produces the greatest increase .
25,645,789
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to examine whether greater exposure to resin-based composite materials , which may intra-orally release bisphenol a ( bpa ) , is associated with worse renal function outcomes in children .", "prospective multi-centre study .", "community health dental clinics in boston and maine from @-@ .", "subjects and methods five hundred and thirty-four new england children 's amalgam trial participants aged six to ten years were randomised to treatment with amalgam or resin-based composite restorations over five years of follow-up .", "restorations were placed according to treatment arm , and sealants placed per standard of care .", "cumulative composite exposure was calculated using surface-years ( each treated surface weighted by number years present ) .", "urinary excretion of albumin , gamma-glutamyl transpeptidase ( gamma-gt ) , and n-acetyl -- d-glucosaminidase ( nag ) were available for @ children .", "analysis of covariance showed no association between exposure to dental composites , polyacid-modified compomer , or flowable composite dental sealants and preventative resin restorations with levels of renal function .", "there was no association between composite materials and thresholds indicating renal damage in logistic regression models .", "this study found no harmful associations between dental composite materials and renal function in children .", "therefore , concerns about renal function need not be a consideration in the choice of dental restoration material or placement of preventative dental sealants ." ]
to examine whether greater exposure to resin-based composite materials , which may intra-orally release bisphenol a ( bpa ) , is associated with worse renal function outcomes in children . prospective multi-centre study . community health dental clinics in boston and maine from @-@ . subjects and methods five hundred and thirty-four new england children 's amalgam trial participants aged six to ten years were randomised to treatment with amalgam or resin-based composite restorations over five years of follow-up . restorations were placed according to treatment arm , and sealants placed per standard of care . cumulative composite exposure was calculated using surface-years ( each treated surface weighted by number years present ) . urinary excretion of albumin , gamma-glutamyl transpeptidase ( gamma-gt ) , and n-acetyl -- d-glucosaminidase ( nag ) were available for @ children . analysis of covariance showed no association between exposure to dental composites , polyacid-modified compomer , or flowable composite dental sealants and preventative resin restorations with levels of renal function . there was no association between composite materials and thresholds indicating renal damage in logistic regression models . this study found no harmful associations between dental composite materials and renal function in children . therefore , concerns about renal function need not be a consideration in the choice of dental restoration material or placement of preventative dental sealants .
24,457,893
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the organ care system is the only clinical platform for ex-vivo perfusion of human donor hearts .", "the system preserves the donor heart in a warm beating state during transport from the donor hospital to the recipient hospital .", "we aimed to assess the clinical outcomes of the organ care system compared with standard cold storage of human donor hearts for transplantation .", "we did this prospective , open-label , multicentre , randomised non-inferiority trial at ten heart-transplant centres in the usa and europe .", "eligible heart-transplant candidates ( aged > @ years ) were randomly assigned ( @:@ ) to receive donor hearts preserved with either the organ care system or standard cold storage .", "participants , investigators , and medical staff were not masked to group assignment .", "the primary endpoint was @ day patient and graft survival , with a @ % non-inferiority margin .", "we did analyses in the intention-to-treat , as-treated , and per-protocol populations .", "this trial is registered with clinicaltrials.gov , number nct@ .", "between june @ , @ , and sept @ , @ , we randomly assigned @ patients to the organ care system group ( n = @ ) or the standard cold storage group ( n = @ ) .", "@ day patient and graft survival rates were @ % ( n = @ ) in the organ care system group and @ % ( n = @ ) in the standard cold storage group ( difference @ % , one-sided @ % upper confidence bound @ ; p = @ ) .", "eight ( @ % ) patients in the organ care system group and nine ( @ % ) patients in the standard cold storage group had cardiac-related serious adverse events .", "heart transplantation using donor hearts adequately preserved with the organ care system or with standard cold storage yield similar short-term clinical outcomes .", "the metabolic assessment capability of the organ care system needs further study .", "transmedics ." ]
the organ care system is the only clinical platform for ex-vivo perfusion of human donor hearts . the system preserves the donor heart in a warm beating state during transport from the donor hospital to the recipient hospital . we aimed to assess the clinical outcomes of the organ care system compared with standard cold storage of human donor hearts for transplantation . we did this prospective , open-label , multicentre , randomised non-inferiority trial at ten heart-transplant centres in the usa and europe . eligible heart-transplant candidates ( aged > @ years ) were randomly assigned ( @:@ ) to receive donor hearts preserved with either the organ care system or standard cold storage . participants , investigators , and medical staff were not masked to group assignment . the primary endpoint was @ day patient and graft survival , with a @ % non-inferiority margin . we did analyses in the intention-to-treat , as-treated , and per-protocol populations . this trial is registered with clinicaltrials.gov , number nct@ . between june @ , @ , and sept @ , @ , we randomly assigned @ patients to the organ care system group ( n = @ ) or the standard cold storage group ( n = @ ) . @ day patient and graft survival rates were @ % ( n = @ ) in the organ care system group and @ % ( n = @ ) in the standard cold storage group ( difference @ % , one-sided @ % upper confidence bound @ ; p = @ ) . eight ( @ % ) patients in the organ care system group and nine ( @ % ) patients in the standard cold storage group had cardiac-related serious adverse events . heart transplantation using donor hearts adequately preserved with the organ care system or with standard cold storage yield similar short-term clinical outcomes . the metabolic assessment capability of the organ care system needs further study . transmedics .
25,888,086
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "interactions between calcium and vitamin d may have implications for the regulation of serum @-hydroxyvitamin d -lsb- @ ( oh ) d -rsb- and its catabolism and , consequently , the vitamin d dietary requirement .", "we investigated whether different calcium intakes influenced serum @ ( oh ) d and indexes of vitamin d activation and catabolism during winter and in the context of both adequate and inadequate vitamin d intakes .", "a @-wk winter-based , randomized , placebo-controlled , double-blind vitamin d intervention ( @ g/d ) study was carried out in free-living men and women aged @ y ( n = @ ) who were stratified according to calcium intakes -lsb- moderate-low ( < @ mg/d ) or high ( > @ mg/d ) intake -rsb- .", "the serum @ ( oh ) d concentration was the primary outcome , and serum calcium , parathyroid hormone ( pth ) , @,@-dihydroxyvitamin d -lsb- @,@ ( oh ) d -rsb- , @,@-dihydroxyvitamin d -lsb- @,@ ( oh ) d -rsb- , the ratio of @,@ ( oh ) d to @ ( oh ) d , vitamin d-binding protein , and free @ ( oh ) d were exploratory outcomes .", "a repeated-measures anova showed there was no significant ( p = @ ) time vitamin d treatment calcium intake grouping interaction effect on the mean serum @ ( oh ) d concentration over the @-wk intervention period .", "serum @ ( oh ) d concentrations increased ( p @ ) and decreased ( p @ ) in vitamin d and placebo groups , respectively , and were of similar magnitudes in subjects with calcium intakes < @ mg/d ( and even < @ mg/d ) compared with > @ mg/d .", "the response of serum pth , @,@ ( oh ) d , @,@ ( oh ) d , the ratio of @,@ ( oh ) d to @ ( oh ) d , and free @ ( oh ) d significantly differed in vitamin d and placebo groups but not by calcium intake grouping .", "we found no evidence of a vitamin d sparing effect of high calcium intake , which has been referred to by some authors as `` vitamin d economy . ''", "thus , recent dietary vitamin d requirement estimates will cover the vitamin d needs of even those individuals who have inadequate calcium intakes ." ]
interactions between calcium and vitamin d may have implications for the regulation of serum @-hydroxyvitamin d -lsb- @ ( oh ) d -rsb- and its catabolism and , consequently , the vitamin d dietary requirement . we investigated whether different calcium intakes influenced serum @ ( oh ) d and indexes of vitamin d activation and catabolism during winter and in the context of both adequate and inadequate vitamin d intakes . a @-wk winter-based , randomized , placebo-controlled , double-blind vitamin d intervention ( @ g/d ) study was carried out in free-living men and women aged @ y ( n = @ ) who were stratified according to calcium intakes -lsb- moderate-low ( < @ mg/d ) or high ( > @ mg/d ) intake -rsb- . the serum @ ( oh ) d concentration was the primary outcome , and serum calcium , parathyroid hormone ( pth ) , @,@-dihydroxyvitamin d -lsb- @,@ ( oh ) d -rsb- , @,@-dihydroxyvitamin d -lsb- @,@ ( oh ) d -rsb- , the ratio of @,@ ( oh ) d to @ ( oh ) d , vitamin d-binding protein , and free @ ( oh ) d were exploratory outcomes . a repeated-measures anova showed there was no significant ( p = @ ) time vitamin d treatment calcium intake grouping interaction effect on the mean serum @ ( oh ) d concentration over the @-wk intervention period . serum @ ( oh ) d concentrations increased ( p @ ) and decreased ( p @ ) in vitamin d and placebo groups , respectively , and were of similar magnitudes in subjects with calcium intakes < @ mg/d ( and even < @ mg/d ) compared with > @ mg/d . the response of serum pth , @,@ ( oh ) d , @,@ ( oh ) d , the ratio of @,@ ( oh ) d to @ ( oh ) d , and free @ ( oh ) d significantly differed in vitamin d and placebo groups but not by calcium intake grouping . we found no evidence of a vitamin d sparing effect of high calcium intake , which has been referred to by some authors as `` vitamin d economy . '' thus , recent dietary vitamin d requirement estimates will cover the vitamin d needs of even those individuals who have inadequate calcium intakes .
24,695,896
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "a recent cochrane review showed that early robotic training of the upper limb in stroke survivors can be more effective than other interventions when improving activities of daily living involving the arm function is the aim of therapy .", "we tested for efficacy of the study a protocol which involved the use of the nerebot therapy in partial substitution of standard upper limb rehabilitation in post-acute stroke patients .", "in this dose-matched , randomized controlled clinical trial , @ hemiparetic participants with movement against gravity in shoulder , elbow , and wrist muscle groups were enrolled within @ days of the onset of stroke .", "all participants received a total daily rehabilitation treatment for @ minutes , @ days per week for @ weeks .", "the control group received standard therapy for the upper limb .", "the experimental group received standard therapy ( @ % of exercise time ) associated with robotic training ( @ % of exercise time ) .", "muscle tone ( modified ashworth scale ) , strength ( medical research council ) , and synergism ( fugl-meyer motor scores ) were measured at impairment level , whereas dexterity ( box and block test and frenchay arm test ) and activities of daily living ( functional independence measure ) were measured at activity level .", "all assessments were performed at baseline , at the end of therapy ( time t@ ) , at @ months ( time t@ ) , and at @ months ( time t@ ) after entry .", "all between-group analyses were tested using nonparametric test with bonferroni 's adjustments for multiple testing .", "no significant between-group differences were found with respect to demographic characteristics , motor , dexterity , and adls at baseline , postintervention ( t@ ) and at follow-up ( t@ and t@ ) .", "the robot therapy by nerebot did not lead to better outcomes compared with conventional inpatient rehabilitation ." ]
a recent cochrane review showed that early robotic training of the upper limb in stroke survivors can be more effective than other interventions when improving activities of daily living involving the arm function is the aim of therapy . we tested for efficacy of the study a protocol which involved the use of the nerebot therapy in partial substitution of standard upper limb rehabilitation in post-acute stroke patients . in this dose-matched , randomized controlled clinical trial , @ hemiparetic participants with movement against gravity in shoulder , elbow , and wrist muscle groups were enrolled within @ days of the onset of stroke . all participants received a total daily rehabilitation treatment for @ minutes , @ days per week for @ weeks . the control group received standard therapy for the upper limb . the experimental group received standard therapy ( @ % of exercise time ) associated with robotic training ( @ % of exercise time ) . muscle tone ( modified ashworth scale ) , strength ( medical research council ) , and synergism ( fugl-meyer motor scores ) were measured at impairment level , whereas dexterity ( box and block test and frenchay arm test ) and activities of daily living ( functional independence measure ) were measured at activity level . all assessments were performed at baseline , at the end of therapy ( time t@ ) , at @ months ( time t@ ) , and at @ months ( time t@ ) after entry . all between-group analyses were tested using nonparametric test with bonferroni 's adjustments for multiple testing . no significant between-group differences were found with respect to demographic characteristics , motor , dexterity , and adls at baseline , postintervention ( t@ ) and at follow-up ( t@ and t@ ) . the robot therapy by nerebot did not lead to better outcomes compared with conventional inpatient rehabilitation .
24,316,679
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS" ]
[ "preventing smoking initiation among adolescents is crucial to reducing tobacco-caused death and disease .", "this study focuses on the effectiveness of a web-based computer-tailored smoking prevention intervention aimed at adolescents .", "the intent of the study was to describe the intervention characteristics and to show the effectiveness and results of a randomized controlled trial .", "we hypothesized that the intervention would prevent smoking initiation among dutch secondary school students aged @-@ years and would have the largest smoking prevention effect among the age cohort of @-@ years , as smoking uptake in that period is highest .", "the intervention consisted of a questionnaire and fully automated computer-tailored feedback on intention to start smoking and motivational determinants .", "a total of @ secondary schools were recruited via postal mail and randomized into either the computer-tailored intervention condition or the control condition .", "participants had to complete a web-based questionnaire at baseline and at @-month follow-up .", "data on smoking initiation were collected from @ students from these schools .", "to identify intervention effects , multilevel logistic regression analyses were conducted using multiple imputation .", "smoking initiation among students aged @-@ years was borderline significantly lower in the experimental condition as compared to the control condition @ months after baseline ( or @ , @ % ci @-@ @ , p = @ ) .", "additional analyses of the data for the @-@ year age group showed a significant effect , with @ % ( @/@ ) of the students in the control condition reporting initiation compared to @ % ( @/@ ) in the experimental condition ( or @ , @ % ci @-@ @ , p = @ ) .", "no moderation effects were found regarding gender and educational level .", "the findings of this study suggest that computer-tailored smoking prevention programs are a promising way of preventing smoking initiation among adolescents for at least @ months , in particular among the age cohort of @-@ years .", "further research is needed to focus on long-term effects .", "international standard randomized controlled trial number ( isrctn ) : @ ; http://www.controlled-trials.com/isrctn@ ( archived by webcite at http://www.webcitation.org/@bslkstm@ ) ." ]
preventing smoking initiation among adolescents is crucial to reducing tobacco-caused death and disease . this study focuses on the effectiveness of a web-based computer-tailored smoking prevention intervention aimed at adolescents . the intent of the study was to describe the intervention characteristics and to show the effectiveness and results of a randomized controlled trial . we hypothesized that the intervention would prevent smoking initiation among dutch secondary school students aged @-@ years and would have the largest smoking prevention effect among the age cohort of @-@ years , as smoking uptake in that period is highest . the intervention consisted of a questionnaire and fully automated computer-tailored feedback on intention to start smoking and motivational determinants . a total of @ secondary schools were recruited via postal mail and randomized into either the computer-tailored intervention condition or the control condition . participants had to complete a web-based questionnaire at baseline and at @-month follow-up . data on smoking initiation were collected from @ students from these schools . to identify intervention effects , multilevel logistic regression analyses were conducted using multiple imputation . smoking initiation among students aged @-@ years was borderline significantly lower in the experimental condition as compared to the control condition @ months after baseline ( or @ , @ % ci @-@ @ , p = @ ) . additional analyses of the data for the @-@ year age group showed a significant effect , with @ % ( @/@ ) of the students in the control condition reporting initiation compared to @ % ( @/@ ) in the experimental condition ( or @ , @ % ci @-@ @ , p = @ ) . no moderation effects were found regarding gender and educational level . the findings of this study suggest that computer-tailored smoking prevention programs are a promising way of preventing smoking initiation among adolescents for at least @ months , in particular among the age cohort of @-@ years . further research is needed to focus on long-term effects . international standard randomized controlled trial number ( isrctn ) : @ ; http://www.controlled-trials.com/isrctn@ ( archived by webcite at http://www.webcitation.org/@bslkstm@ ) .
24,657,434
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "endoscopic biliary sphincterotomy and stone removal is the standard of care for choledocholithiasis , with a success rate of > @ % .", "for stones @ mm diameter , mechanical lithotripsy , extracorporeal shock wave lithotripsy , electrohydraulic lithotripsy , and laser lithotripsy can be used .", "in the case of failure , the next step is surgery .", "in elderly patients and in patients with an elevated surgical risk , stenting is the only treatment modality .", "in these cases the aim is to avoid the onset of acute obstructive cholangitis .", "the aim of the current study was to evaluate the best management of plastic stents in patients with biliary duct stones who were unfit for surgery and in whom previous endoscopic therapy had failed .", "patients who were high surgical risks and in whom stone clearance was not possible due to the number and sizes of stones were included .", "between march @ and september @ all patients were treated with endoscopic plastic biliary stenting at four tertiary care referral centers in italy .", "patients were randomly assigned to two groups : in group a ( n = @ ) plastic stents were changed every @ months or sooner if symptoms appeared ; in group b plastic stents were changed on demand at the onset of symptoms , and ultrasonography and blood samples were performed every @ months to check for signs of cholestasis and inflammation .", "the primary outcome was the rate of cholangitis .", "the secondary outcome was the rate of stone clearance after a period of stenting .", "a total of @ patients were included in the study ( @m/@f ; mean age @ years ) .", "acute cholangitis occurred in @ patients from group a and in @ patients from group b ( p = @ ) .", "mortality related to cholangitis occurred in one patient from group a and three patients from group b ( p = n.s. ) .", "the mean follow-up was @ months ( range @-@ ) .", "stone clearance after long term stenting occurred in @ patients from group a ( @ % ) and in @ patients from group b ( @ % ) ( p = n.s. ) .", "in patients with bile duct stones who were treated with biliary plastic stents , the best stent management to avoid cholangitis was stent changing at defined intervals ( every @ months in the current study ) .", "the data confirmed that plastic biliary stenting may decrease stone size with a high percentage of subsequent total stone clearance ." ]
endoscopic biliary sphincterotomy and stone removal is the standard of care for choledocholithiasis , with a success rate of > @ % . for stones @ mm diameter , mechanical lithotripsy , extracorporeal shock wave lithotripsy , electrohydraulic lithotripsy , and laser lithotripsy can be used . in the case of failure , the next step is surgery . in elderly patients and in patients with an elevated surgical risk , stenting is the only treatment modality . in these cases the aim is to avoid the onset of acute obstructive cholangitis . the aim of the current study was to evaluate the best management of plastic stents in patients with biliary duct stones who were unfit for surgery and in whom previous endoscopic therapy had failed . patients who were high surgical risks and in whom stone clearance was not possible due to the number and sizes of stones were included . between march @ and september @ all patients were treated with endoscopic plastic biliary stenting at four tertiary care referral centers in italy . patients were randomly assigned to two groups : in group a ( n = @ ) plastic stents were changed every @ months or sooner if symptoms appeared ; in group b plastic stents were changed on demand at the onset of symptoms , and ultrasonography and blood samples were performed every @ months to check for signs of cholestasis and inflammation . the primary outcome was the rate of cholangitis . the secondary outcome was the rate of stone clearance after a period of stenting . a total of @ patients were included in the study ( @m/@f ; mean age @ years ) . acute cholangitis occurred in @ patients from group a and in @ patients from group b ( p = @ ) . mortality related to cholangitis occurred in one patient from group a and three patients from group b ( p = n.s. ) . the mean follow-up was @ months ( range @-@ ) . stone clearance after long term stenting occurred in @ patients from group a ( @ % ) and in @ patients from group b ( @ % ) ( p = n.s. ) . in patients with bile duct stones who were treated with biliary plastic stents , the best stent management to avoid cholangitis was stent changing at defined intervals ( every @ months in the current study ) . the data confirmed that plastic biliary stenting may decrease stone size with a high percentage of subsequent total stone clearance .
24,288,221
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "previous analyses from a randomized trial in women aged @-@ have shown the quadrivalent hpv vaccine to be efficacious in the prevention of infection , cervical intraepithelial neoplasia ( cin ) and external genital lesions ( egl ) related to hpv @/@/@ / @ through @ years .", "in this report we present long term follow-up data on the efficacy , safety and immunogenicity of the quadrivalent hpv vaccine in adult women .", "follow-up data are from a study being conducted in @ sites in colombia designed to evaluate the long-term immunogenicity , effectiveness , and safety of the qhpv vaccine in women who were vaccinated at @ to @ years of age ( in the original vaccine group during the base study -lsb- n = @ -rsb- ) or @ to @ years of age ( in the original placebo group during the base study -lsb- n = @ -rsb- ) .", "this analysis summarizes data collected as of the year @ post-vaccination visit relative to day @ of the base study ( median follow-up of @ years ) from both the original base study and the colombian follow-up .", "there were no cases of hpv @/@/@ / @-related cin or egl during the extended follow-up phase in the per-protocol population .", "immunogenicity persists against vaccine-related hpv types , and no evidence of hpv type replacement has been observed .", "no new serious adverse experiences have been reported .", "vaccination with qhpv vaccine provides generally safe and effective protection from hpv @ - , @ - , @ - , and @-related genital warts and cervical dysplasia through @ years following administration to @-@ year-old women .", "clinicaltrials.govnct@ ." ]
previous analyses from a randomized trial in women aged @-@ have shown the quadrivalent hpv vaccine to be efficacious in the prevention of infection , cervical intraepithelial neoplasia ( cin ) and external genital lesions ( egl ) related to hpv @/@/@ / @ through @ years . in this report we present long term follow-up data on the efficacy , safety and immunogenicity of the quadrivalent hpv vaccine in adult women . follow-up data are from a study being conducted in @ sites in colombia designed to evaluate the long-term immunogenicity , effectiveness , and safety of the qhpv vaccine in women who were vaccinated at @ to @ years of age ( in the original vaccine group during the base study -lsb- n = @ -rsb- ) or @ to @ years of age ( in the original placebo group during the base study -lsb- n = @ -rsb- ) . this analysis summarizes data collected as of the year @ post-vaccination visit relative to day @ of the base study ( median follow-up of @ years ) from both the original base study and the colombian follow-up . there were no cases of hpv @/@/@ / @-related cin or egl during the extended follow-up phase in the per-protocol population . immunogenicity persists against vaccine-related hpv types , and no evidence of hpv type replacement has been observed . no new serious adverse experiences have been reported . vaccination with qhpv vaccine provides generally safe and effective protection from hpv @ - , @ - , @ - , and @-related genital warts and cervical dysplasia through @ years following administration to @-@ year-old women . clinicaltrials.govnct@ .
24,391,768
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]
[ "to evaluate whether trabectedin as first-line chemotherapy for advanced/metastatic soft tissue sarcoma prolongs progression-free survival ( pfs ) , compared to doxorubicin and , in the phase iib part here , to select the most appropriate trabectedin treatment schedule ( @-hour or @-hour infusion ) in terms of safety , convenience and efficacy .", "in this randomised multicentre prospective dose-selection phase iib superiority trial , @ patients were randomised between doxorubicin ( n = @ ) , trabectedin ( @-hour infusion , t@h ) ( n = @ ) and trabectedin ( @-hour infusion , t@h ) ( n = @ ) .", "pfs was defined as time from random assignment until objective progression by response evaluation criteria in solid tumours ( recist @ ) , a global deterioration of the health status requiring discontinuation of the treatment , or death from any cause .", "the study was terminated due to lack of superiority in both trabectedin treatment arms as compared to the doxorubicin control arm .", "median pfs was @ months in the t@h arm , @ months in the t@h arm and @ months in the doxorubicin arm .", "no significant improvements in pfs were observed in the trabectedin arms as compared to the doxorubicin arm ( t@h versus doxorubicin : hazard ratio ( hr ) @ , @ % confidence interval ( ci ) @-@ @ , p = @ ; t@h versus doxorubicin : hr @ , @ % ci @-@ @ , p = @ ) .", "only one toxic death occurred in the t@h arm , but treatment had to be stopped due to toxicity in @ ( @ % ) ( t@h ) , @ ( @ % ) ( t@h ) and @ ( @ % ) doxorubicin patients .", "doxorubicin continues to be the standard treatment in eligible patients with advanced/metastatic soft-tissue sarcoma ( sts ) .", "trabectedin @ mg/m ( @ ) / @-hour infusion is the overall proven approach to delivering this agent in the second-line setting for patients with advanced or metastatic sts ." ]
to evaluate whether trabectedin as first-line chemotherapy for advanced/metastatic soft tissue sarcoma prolongs progression-free survival ( pfs ) , compared to doxorubicin and , in the phase iib part here , to select the most appropriate trabectedin treatment schedule ( @-hour or @-hour infusion ) in terms of safety , convenience and efficacy . in this randomised multicentre prospective dose-selection phase iib superiority trial , @ patients were randomised between doxorubicin ( n = @ ) , trabectedin ( @-hour infusion , t@h ) ( n = @ ) and trabectedin ( @-hour infusion , t@h ) ( n = @ ) . pfs was defined as time from random assignment until objective progression by response evaluation criteria in solid tumours ( recist @ ) , a global deterioration of the health status requiring discontinuation of the treatment , or death from any cause . the study was terminated due to lack of superiority in both trabectedin treatment arms as compared to the doxorubicin control arm . median pfs was @ months in the t@h arm , @ months in the t@h arm and @ months in the doxorubicin arm . no significant improvements in pfs were observed in the trabectedin arms as compared to the doxorubicin arm ( t@h versus doxorubicin : hazard ratio ( hr ) @ , @ % confidence interval ( ci ) @-@ @ , p = @ ; t@h versus doxorubicin : hr @ , @ % ci @-@ @ , p = @ ) . only one toxic death occurred in the t@h arm , but treatment had to be stopped due to toxicity in @ ( @ % ) ( t@h ) , @ ( @ % ) ( t@h ) and @ ( @ % ) doxorubicin patients . doxorubicin continues to be the standard treatment in eligible patients with advanced/metastatic soft-tissue sarcoma ( sts ) . trabectedin @ mg/m ( @ ) / @-hour infusion is the overall proven approach to delivering this agent in the second-line setting for patients with advanced or metastatic sts .
25,912,752
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "esophageal cancer is among the most common gastrointestinal cancers for which the main treatment is surgery .", "this study was undertaken to analyze the results of botox injection in preventing gastric stasis in these patients .", "@ patients with esophageal cancer in the middle and lower third parts were included in our study between @ and @ , and were randomly divided into two groups .", "in group a , @ patients underwent pyloroplasty , and in group b , injection of botulinum toxin into the pyloric sphincter muscle was used in @ patients .", "the mean age of these patients was @ years and the male/female ratio was @:@ .", "isotope scans @ weeks after surgery showed that @ patients in group a and @ in group b had delayed gastric emptying ; there was no significant difference between the @ groups , and the success rate of botox injection was @ % .", "considering the fact that there was no significant difference between pyloroplasty and botox injection on gastric emptying after surgery , and given the need to use less-aggressive techniques and facilitate greater use of endoscopic methods , botulinum toxin injection may be used instead of pyloroplasty as a simple , effective , and complication-free method to prevent delayed gastric emptying ." ]
esophageal cancer is among the most common gastrointestinal cancers for which the main treatment is surgery . this study was undertaken to analyze the results of botox injection in preventing gastric stasis in these patients . @ patients with esophageal cancer in the middle and lower third parts were included in our study between @ and @ , and were randomly divided into two groups . in group a , @ patients underwent pyloroplasty , and in group b , injection of botulinum toxin into the pyloric sphincter muscle was used in @ patients . the mean age of these patients was @ years and the male/female ratio was @:@ . isotope scans @ weeks after surgery showed that @ patients in group a and @ in group b had delayed gastric emptying ; there was no significant difference between the @ groups , and the success rate of botox injection was @ % . considering the fact that there was no significant difference between pyloroplasty and botox injection on gastric emptying after surgery , and given the need to use less-aggressive techniques and facilitate greater use of endoscopic methods , botulinum toxin injection may be used instead of pyloroplasty as a simple , effective , and complication-free method to prevent delayed gastric emptying .
24,569,327
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "social support is associated with enhanced illness management and recovery in persons with mental illness , making it an important topic addressed through acute inpatient psychoeducational programs .", "in addition , trust in the therapist may mediate clinical outcomes in this patient population .", "to date , few studies have examined the effect of music-based psychoeducational programs on these variables .", "the purpose of this study was to isolate and examine the component parts of a live educational music therapy intervention , and its effect on acute psychiatric inpatients ' perceived social support from significant others , family , and friends and trust in the therapist .", "this study also explored whether trust in therapist varied across conditions , but did not examine it as a mediator for social support .", "participants ( n = @ ) were cluster-randomized in a single-session posttest-only design to one of four conditions : live educational music therapy , recorded educational music therapy , education without music , or recreational music therapy without education .", "conditions were designed to isolate the following intervention components : live vs. recorded music , educational vs. non-educational content , and music vs. nonmusic modality .", "dependent measures were assessed post intervention via established self-report instruments evaluating perceived social support and trust in the therapist .", "there were no significant between-group differences for social support or trust in therapist total scores .", "however , subscale score analyses revealed two significant between-group differences : ( a ) participants in the live educational music therapy condition reported significantly higher perceived therapist competence compared with the recorded educational music therapy condition ; ( b ) participants in the live educational music therapy condition reported significantly higher perceived support from friends compared with the recreational music therapy condition .", "live educational music therapy may be a way to heighten psychiatric inpatients ' perceived social support concerning friends and perceptions of the therapist 's competence .", "the current results demonstrated differences between live and recorded music therapy in psychiatric music therapy and provide empirical support for competent musicianship .", "implications for clinical practice , limitations , and suggestions for future research are included ." ]
social support is associated with enhanced illness management and recovery in persons with mental illness , making it an important topic addressed through acute inpatient psychoeducational programs . in addition , trust in the therapist may mediate clinical outcomes in this patient population . to date , few studies have examined the effect of music-based psychoeducational programs on these variables . the purpose of this study was to isolate and examine the component parts of a live educational music therapy intervention , and its effect on acute psychiatric inpatients ' perceived social support from significant others , family , and friends and trust in the therapist . this study also explored whether trust in therapist varied across conditions , but did not examine it as a mediator for social support . participants ( n = @ ) were cluster-randomized in a single-session posttest-only design to one of four conditions : live educational music therapy , recorded educational music therapy , education without music , or recreational music therapy without education . conditions were designed to isolate the following intervention components : live vs. recorded music , educational vs. non-educational content , and music vs. nonmusic modality . dependent measures were assessed post intervention via established self-report instruments evaluating perceived social support and trust in the therapist . there were no significant between-group differences for social support or trust in therapist total scores . however , subscale score analyses revealed two significant between-group differences : ( a ) participants in the live educational music therapy condition reported significantly higher perceived therapist competence compared with the recorded educational music therapy condition ; ( b ) participants in the live educational music therapy condition reported significantly higher perceived support from friends compared with the recreational music therapy condition . live educational music therapy may be a way to heighten psychiatric inpatients ' perceived social support concerning friends and perceptions of the therapist 's competence . the current results demonstrated differences between live and recorded music therapy in psychiatric music therapy and provide empirical support for competent musicianship . implications for clinical practice , limitations , and suggestions for future research are included .
25,057,140
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "hyperventilation has been associated with adverse effects on lung function , symptoms , and well-being in asthma .", "we examined whether raising end-tidal co@ levels ( ie , pco@ ) compared with slow breathing is associated with improvements in asthma control , including peak flow variability .", "one hundred twenty patients with asthma were randomly assigned to capnometry-assisted respiratory training ( cart ) for raising pco@ or slow breathing and awareness training ( slow ) for slowing respiratory rate .", "patients received five weekly sessions and completed bid homework exercises over @ weeks .", "blinded assessments at baseline , posttreatment , @ - and @-month follow-up of asthma control , pco@ , and diurnal peak flow variability were primary outcome measures .", "additionally , we measured pulmonary function ( spirometry , forced oscillation , exhaled nitric oxide , and methacholine challenge ) , symptoms , quality of life , and bronchodilator use .", "because the control group received active treatment , we expected improvements in asthma control in both groups but more pronounced benefits from cart .", "improvements were seen in @ of @ clinical indexes ( @ % ) in both interventions , including the primary outcome variables asthma control ( d = @ ) , peak flow variability ( d = @ ) , quality of life , bronchodilator use , lung function , and airway hyperreactivity .", "most improvements were sustained across the @-month follow-up .", "compared with slow breathing , cart showed greater increases in pco@ ( d = @ vs @ for cart vs slow , respectively ) and greater reductions in respiratory impedance during treatment , less distress during methacholine challenge , and greater reduction in asthma symptoms at follow-up ( p < @ ) .", "brief interventions aimed at raising pco@ or slowing respiratory rate provide significant , sustained , and clinically meaningful improvements in asthma control .", "raising pco@ was associated with greater benefits in aspects of lung function and long-term symptoms .", "clinicaltrials.gov ; no. : nct@ ; url : www.clinicaltrials.gov ." ]
hyperventilation has been associated with adverse effects on lung function , symptoms , and well-being in asthma . we examined whether raising end-tidal co@ levels ( ie , pco@ ) compared with slow breathing is associated with improvements in asthma control , including peak flow variability . one hundred twenty patients with asthma were randomly assigned to capnometry-assisted respiratory training ( cart ) for raising pco@ or slow breathing and awareness training ( slow ) for slowing respiratory rate . patients received five weekly sessions and completed bid homework exercises over @ weeks . blinded assessments at baseline , posttreatment , @ - and @-month follow-up of asthma control , pco@ , and diurnal peak flow variability were primary outcome measures . additionally , we measured pulmonary function ( spirometry , forced oscillation , exhaled nitric oxide , and methacholine challenge ) , symptoms , quality of life , and bronchodilator use . because the control group received active treatment , we expected improvements in asthma control in both groups but more pronounced benefits from cart . improvements were seen in @ of @ clinical indexes ( @ % ) in both interventions , including the primary outcome variables asthma control ( d = @ ) , peak flow variability ( d = @ ) , quality of life , bronchodilator use , lung function , and airway hyperreactivity . most improvements were sustained across the @-month follow-up . compared with slow breathing , cart showed greater increases in pco@ ( d = @ vs @ for cart vs slow , respectively ) and greater reductions in respiratory impedance during treatment , less distress during methacholine challenge , and greater reduction in asthma symptoms at follow-up ( p < @ ) . brief interventions aimed at raising pco@ or slowing respiratory rate provide significant , sustained , and clinically meaningful improvements in asthma control . raising pco@ was associated with greater benefits in aspects of lung function and long-term symptoms . clinicaltrials.gov ; no. : nct@ ; url : www.clinicaltrials.gov .
25,122,497
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "selective serotonin reuptake inhibitors ( ssris ) are common treatments for patients with major depressive disorder ( mdd ) .", "however , adverse effects of ssris on sexual function are common in the treatment of patients with mdd .", "there is a discrepancy in the reported frequency of ssri-induced sexual dysfunction .", "on the other hand , there is also less evidence about sexual dysfunction with serotonin receptor antagonists and reuptake inhibitors ( saris ) .", "therefore , we aimed to assess sexual dysfunction in mdd patients who received fluoxetine , sertraline and trazodone .", "in a single-blind , randomized , controlled trial in kermanshah , iran , during @-@ , @ patients who met the dsmiv-ir criteria for mdd were enrolled .", "the patients completed the hamilton depression rating scale ( ham-d ) and the sexual function questionnaire ( sfq ) .", "eligible patients were allocated in three treatment groups ( receiving fluoxetine , sertraline or trazodone ) for @ weeks randomly .", "measurement of hamd was repeated in @-week interval .", "analysis for comparing sexual dysfunction among three groups and men and women was performed .", "there were @ men and @ women in the three groups receiving fluoxetine ( n = @ ) , sertraline ( n = @ ) and trazodone ( n = @ ) .", "there was no significant difference in the sexual dysfunction of the patients in the three groups at baseline ( p > @ ) .", "after treatment , both men and women who had received fluoxetine had the most impairment in desire/drive items ( @ % -@ % and @ % -@ % , respectively ) , while patients receiving trazodone had the least impairment in these items ( @ % -@ % and @ % -@ % , respectively ) .", "trazodone was also induced with a lower rate of impairment in arousal/orgasm items in men ( @ % -@ % ) compared with the other two drugs .", "compared with fluoxetine and trazodone , sertraline was associated with intermediate impairment in sexual function ( @ % -@ % in desire/drive items and @ % -@ % in arousal/orgasm items ) that was lower than that with fluoxetine and more than that with trazodone .", "there were different rates of sexual dysfunction with different antidepressants drugs in under treated patients .", "compared with fluoxetine , and sertraline , trazodone was associated with the fewest sexual dysfunction .", "fluoxetine was also associated with more sexual dysfunction than sertraline .", "further research to better identify the differences among antidepressant drugs is recommended ." ]
selective serotonin reuptake inhibitors ( ssris ) are common treatments for patients with major depressive disorder ( mdd ) . however , adverse effects of ssris on sexual function are common in the treatment of patients with mdd . there is a discrepancy in the reported frequency of ssri-induced sexual dysfunction . on the other hand , there is also less evidence about sexual dysfunction with serotonin receptor antagonists and reuptake inhibitors ( saris ) . therefore , we aimed to assess sexual dysfunction in mdd patients who received fluoxetine , sertraline and trazodone . in a single-blind , randomized , controlled trial in kermanshah , iran , during @-@ , @ patients who met the dsmiv-ir criteria for mdd were enrolled . the patients completed the hamilton depression rating scale ( ham-d ) and the sexual function questionnaire ( sfq ) . eligible patients were allocated in three treatment groups ( receiving fluoxetine , sertraline or trazodone ) for @ weeks randomly . measurement of hamd was repeated in @-week interval . analysis for comparing sexual dysfunction among three groups and men and women was performed . there were @ men and @ women in the three groups receiving fluoxetine ( n = @ ) , sertraline ( n = @ ) and trazodone ( n = @ ) . there was no significant difference in the sexual dysfunction of the patients in the three groups at baseline ( p > @ ) . after treatment , both men and women who had received fluoxetine had the most impairment in desire/drive items ( @ % -@ % and @ % -@ % , respectively ) , while patients receiving trazodone had the least impairment in these items ( @ % -@ % and @ % -@ % , respectively ) . trazodone was also induced with a lower rate of impairment in arousal/orgasm items in men ( @ % -@ % ) compared with the other two drugs . compared with fluoxetine and trazodone , sertraline was associated with intermediate impairment in sexual function ( @ % -@ % in desire/drive items and @ % -@ % in arousal/orgasm items ) that was lower than that with fluoxetine and more than that with trazodone . there were different rates of sexual dysfunction with different antidepressants drugs in under treated patients . compared with fluoxetine , and sertraline , trazodone was associated with the fewest sexual dysfunction . fluoxetine was also associated with more sexual dysfunction than sertraline . further research to better identify the differences among antidepressant drugs is recommended .
25,467,077
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to evaluate the potential efficacy of buspirone as a relapse-prevention treatment for cocaine dependence .", "a randomized , double-blind , placebo-controlled , @-week pilot trial was conducted at @ clinical sites between august @ and june @ .", "adult crack cocaine users meeting dsm-iv-tr criteria for current cocaine dependence who were scheduled to be in inpatient/residential substance use disorder ( sud ) treatment for @-@ days when randomized and planning to enroll in local outpatient treatment through the end of the active treatment phase were randomized to buspirone titrated to @ mg/d ( n = @ ) or placebo ( n = @ ) .", "all participants received psychosocial treatment as usually provided by the sud treatment programs in which they were enrolled .", "outcome measures included maximum days of continuous cocaine abstinence ( primary ) , proportion of cocaine use days , and days to first cocaine use during the outpatient treatment phase ( study weeks @-@ ) as assessed by self-report and urine drug screens .", "there were no significant treatment effects on maximum continuous days of cocaine abstinence or days to first cocaine use .", "in the female participants ( n = @ ) , there was a significant treatment-by-time interaction effect ( = @ , p < @ ) , reflecting an increase in cocaine use by those receiving buspirone , relative to placebo , early in the outpatient treatment phase .", "a similar effect was not detected in the male participants ( n = @ ; = @ , p = @ ) .", "the results suggest that buspirone is unlikely to have a beneficial effect on preventing relapse to cocaine use and that buspirone for cocaine-dependent women may worsen their cocaine use outcomes .", "clinicaltrials.gov identifier : nct@ ." ]
to evaluate the potential efficacy of buspirone as a relapse-prevention treatment for cocaine dependence . a randomized , double-blind , placebo-controlled , @-week pilot trial was conducted at @ clinical sites between august @ and june @ . adult crack cocaine users meeting dsm-iv-tr criteria for current cocaine dependence who were scheduled to be in inpatient/residential substance use disorder ( sud ) treatment for @-@ days when randomized and planning to enroll in local outpatient treatment through the end of the active treatment phase were randomized to buspirone titrated to @ mg/d ( n = @ ) or placebo ( n = @ ) . all participants received psychosocial treatment as usually provided by the sud treatment programs in which they were enrolled . outcome measures included maximum days of continuous cocaine abstinence ( primary ) , proportion of cocaine use days , and days to first cocaine use during the outpatient treatment phase ( study weeks @-@ ) as assessed by self-report and urine drug screens . there were no significant treatment effects on maximum continuous days of cocaine abstinence or days to first cocaine use . in the female participants ( n = @ ) , there was a significant treatment-by-time interaction effect ( = @ , p < @ ) , reflecting an increase in cocaine use by those receiving buspirone , relative to placebo , early in the outpatient treatment phase . a similar effect was not detected in the male participants ( n = @ ; = @ , p = @ ) . the results suggest that buspirone is unlikely to have a beneficial effect on preventing relapse to cocaine use and that buspirone for cocaine-dependent women may worsen their cocaine use outcomes . clinicaltrials.gov identifier : nct@ .
24,911,028
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]
[ "people with intellectual disabilities ( id ) have lower levels of physical activity and quality of life and they have a lot of barriers to face when taking part in physical activity .", "other problems are the poor adherence to physical activity such people have so this study is designed to improve adherence to physical activity for people with intellectual disabilities with the assistance of an application for smartphones .", "the aim of the study will be to improve physical activity and physical condition after multimodal intervention and to analyse the promotion of adherence to physical activity through a multimodal intervention and an app intervention ( mhealth ) in people with id .", "a two-stage study will be conducted .", "in stage @ a multimodal intervention will take place will be done with physical activity and educational advice over eight weeks , two days a week .", "data will be measured after and before the intervention .", "in stage @ a randomized controlled trial will be conducted .", "in the intervention group we will install an application to a smartphone ; this application will be a reminder to do a physical activity and they have to select whether they have or have n't done a physical activity every day .", "this application will be installed for @ weeks .", "data will be measured after and before the application is installed in two groups .", "we will measure results @ weeks later when the two groups do n't have the reminder .", "the principal outcome used to measure the adherence to physical activity will be the international physical activity questionnaire ; secondary outcomes will be a fun-fitness test and self-report survey about quality of life , self-efficacy and social support .", "samples will be randomized by sealed envelope in two groups , with approximately @ subjects in each group .", "it 's important to know that the therapist will be blinded and wo n't know the subjects of each group .", "offering people with id a multimodal intervention and tool to increase the adherence to a physical activity may increase the levels of physical activity and quality of life .", "such a scheme , if beneficial , could be implemented successfully within public health sense .", "clinicaltrials.gov identifier : nct@ ." ]
people with intellectual disabilities ( id ) have lower levels of physical activity and quality of life and they have a lot of barriers to face when taking part in physical activity . other problems are the poor adherence to physical activity such people have so this study is designed to improve adherence to physical activity for people with intellectual disabilities with the assistance of an application for smartphones . the aim of the study will be to improve physical activity and physical condition after multimodal intervention and to analyse the promotion of adherence to physical activity through a multimodal intervention and an app intervention ( mhealth ) in people with id . a two-stage study will be conducted . in stage @ a multimodal intervention will take place will be done with physical activity and educational advice over eight weeks , two days a week . data will be measured after and before the intervention . in stage @ a randomized controlled trial will be conducted . in the intervention group we will install an application to a smartphone ; this application will be a reminder to do a physical activity and they have to select whether they have or have n't done a physical activity every day . this application will be installed for @ weeks . data will be measured after and before the application is installed in two groups . we will measure results @ weeks later when the two groups do n't have the reminder . the principal outcome used to measure the adherence to physical activity will be the international physical activity questionnaire ; secondary outcomes will be a fun-fitness test and self-report survey about quality of life , self-efficacy and social support . samples will be randomized by sealed envelope in two groups , with approximately @ subjects in each group . it 's important to know that the therapist will be blinded and wo n't know the subjects of each group . offering people with id a multimodal intervention and tool to increase the adherence to a physical activity may increase the levels of physical activity and quality of life . such a scheme , if beneficial , could be implemented successfully within public health sense . clinicaltrials.gov identifier : nct@ .
24,330,604
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "we report updated progression-free survival ( pfs ) and overall survival ( os ) data from a trial that compared capecitabine plus oxaliplatin ( capeox ) versus s-@ plus oxaliplatin ( sox ) for the first-line treatment of metastatic colorectal cancer .", "this trial was a randomized , two-armed , non-inferiority phase @ comparison of capeox ( capecitabine @ mg/m@ twice daily on days @-@ and oxaliplatin @ mg/m@ on day @ ) versus sox ( s-@ @ mg/m@ twice daily on days @-@ and oxaliplatin @ mg/m@ on day @ ) .", "the primary end point was to show non-inferiority of sox relative to capeox in terms of pfs .", "thus , a follow-up exploratory analysis of pfs and os was performed .", "the intention to treat ( itt ) population was comprised of @ patients ( sox arm : @ and capeox arm : @ ) .", "the updated median pfs was @ months ( @ % ci @-@ @ ) in the sox group and @ months ( @ % ci @-@ @ ) in the capeox group ( hazard ratio -lsb- hr -rsb- , @ -lsb- @-@ @ -rsb- , p = @ ) .", "the median os was @ months ( @ % ci @-@ @ ) in the sox group and @ months ( @ % ci @-@ @ ) in the capeox group ( hr , @ -lsb- @-@ @ -rsb- , p = @ ) .", "subgroup analyses according to principal demographic factors such as sex , age , ecog ( eastern cooperative oncology group ) performance status , primary tumor location , measurability , previous adjuvant therapy , number of metastatic organs , and liver metastases showed no interaction between any of these characteristics and the treatment .", "updated survival analysis shows that sox is similar to capeox , confirming the initial pfs analysis .", "therefore , the sox regimen could be an alternative first-line doublet chemotherapy strategy for patients with metastatic colorectal cancer .", "nct@ and may @ @ ." ]
we report updated progression-free survival ( pfs ) and overall survival ( os ) data from a trial that compared capecitabine plus oxaliplatin ( capeox ) versus s-@ plus oxaliplatin ( sox ) for the first-line treatment of metastatic colorectal cancer . this trial was a randomized , two-armed , non-inferiority phase @ comparison of capeox ( capecitabine @ mg/m@ twice daily on days @-@ and oxaliplatin @ mg/m@ on day @ ) versus sox ( s-@ @ mg/m@ twice daily on days @-@ and oxaliplatin @ mg/m@ on day @ ) . the primary end point was to show non-inferiority of sox relative to capeox in terms of pfs . thus , a follow-up exploratory analysis of pfs and os was performed . the intention to treat ( itt ) population was comprised of @ patients ( sox arm : @ and capeox arm : @ ) . the updated median pfs was @ months ( @ % ci @-@ @ ) in the sox group and @ months ( @ % ci @-@ @ ) in the capeox group ( hazard ratio -lsb- hr -rsb- , @ -lsb- @-@ @ -rsb- , p = @ ) . the median os was @ months ( @ % ci @-@ @ ) in the sox group and @ months ( @ % ci @-@ @ ) in the capeox group ( hr , @ -lsb- @-@ @ -rsb- , p = @ ) . subgroup analyses according to principal demographic factors such as sex , age , ecog ( eastern cooperative oncology group ) performance status , primary tumor location , measurability , previous adjuvant therapy , number of metastatic organs , and liver metastases showed no interaction between any of these characteristics and the treatment . updated survival analysis shows that sox is similar to capeox , confirming the initial pfs analysis . therefore , the sox regimen could be an alternative first-line doublet chemotherapy strategy for patients with metastatic colorectal cancer . nct@ and may @ @ .
25,424,120
[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "report long-term outcomes of the nourish randomized controlled trial ( rct ) , which evaluated a universal intervention commencing in infancy to provide anticipatory guidance to first-time mothers on `` protective '' complementary feeding practices that were hypothesized to reduce childhood obesity risk .", "the nourish rct enrolled @ mothers ( mean age @ years , sd = @ ) with healthy term infants ( @ % female ) .", "mothers were randomly allocated to usual care or to attend two @-session , @-week group education modules .", "outcomes were assessed @ times : baseline ( infants @ months ) ; @ months after module @ ( infants @ months ) ; @ months after module @ ( infants @ years ) and at @ and @ years of age .", "maternal feeding practices were self-reported using validated questionnaires .", "bmi z-score was calculated from measured child height and weight .", "linear mixed models evaluated intervention ( group ) effect across time .", "retention at age @ years was @ % .", "across ages @ to @ years , intervention mothers reported less frequent use of nonresponsive feeding practices on @ of @ scales .", "at @ years , they also reported more appropriate responses to food refusal on @ of @ items ( ps @ ) .", "no statistically significant group effect was noted for anthropometric outcomes ( bmi z-score : p = @ ) or the prevalence of overweight/obesity ( control @ % vs intervention @ % , p = @ ) .", "anticipatory guidance on complementary feeding resulted in first-time mothers reporting increased use of protective feeding practices .", "these intervention effects were sustained up to @ years of age and were paralleled by a nonsignificant trend for lower child bmi z-scores at all postintervention assessment points ." ]
report long-term outcomes of the nourish randomized controlled trial ( rct ) , which evaluated a universal intervention commencing in infancy to provide anticipatory guidance to first-time mothers on `` protective '' complementary feeding practices that were hypothesized to reduce childhood obesity risk . the nourish rct enrolled @ mothers ( mean age @ years , sd = @ ) with healthy term infants ( @ % female ) . mothers were randomly allocated to usual care or to attend two @-session , @-week group education modules . outcomes were assessed @ times : baseline ( infants @ months ) ; @ months after module @ ( infants @ months ) ; @ months after module @ ( infants @ years ) and at @ and @ years of age . maternal feeding practices were self-reported using validated questionnaires . bmi z-score was calculated from measured child height and weight . linear mixed models evaluated intervention ( group ) effect across time . retention at age @ years was @ % . across ages @ to @ years , intervention mothers reported less frequent use of nonresponsive feeding practices on @ of @ scales . at @ years , they also reported more appropriate responses to food refusal on @ of @ items ( ps @ ) . no statistically significant group effect was noted for anthropometric outcomes ( bmi z-score : p = @ ) or the prevalence of overweight/obesity ( control @ % vs intervention @ % , p = @ ) . anticipatory guidance on complementary feeding resulted in first-time mothers reporting increased use of protective feeding practices . these intervention effects were sustained up to @ years of age and were paralleled by a nonsignificant trend for lower child bmi z-scores at all postintervention assessment points .
26,055,848
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "dantrolene is neuroprotective in animal models and may attenuate cerebral vasospasm ( cvsp ) in human aneurysmal subarachnoid haemorrhage ( asah ) .", "we evaluated safety , feasibility and tolerability of intravenous dantrolene ( iv-d ) in patients with asah .", "in this single-centre , randomised , double blind , placebo-controlled trial , @ patients with asah were randomised to iv-d @ mg every @h for @days ( n = @ ) or equiosmolar free water/@ % mannitol ( placebo ; n = @ ) .", "primary safety end points were incidence of hyponatraemia ( sna@mmol/l ) and liver toxicity ( proportion of patients alanine transaminase , aspartate aminotransferase and alkphos > @ upper-limit-of-normal ) .", "secondary end points included tolerability , systemic hypotension and intracranial hypertension .", "efficacy was explored for clinical/radiological cvsp , delayed cerebral ischaemia ( dci ) , and @-month functional outcomes .", "quantitative analyses of angiograms and daily transcranial doppler ( tcd ) were performed .", "between iv-d versus placebo , no differences were observed in the primary outcomes ( hyponatremia @ % vs @ % ( p = @ ) ; liver toxicity @ % vs @ % ( p = @ ) ) .", "three patients in the iv-d versus two in the placebo group had severe adverse events possibly attributable to infusion and reached stop criteria : one iv-d patient developed liver toxicity ; two patients in each group developed brain oedema requiring osmotherapy .", "the majority of adverse events were not related to infusion ( @ vs @ ( rr @ ; @ % ci @ to @ ; p = @ ) in iv-d vs placebo ) .", "no differences in any categorical cvsp outcomes , dci , @-month outcomes or quantitative angiogram and tcd analyses were seen in this small safety trial not powered to detect efficacy .", "in this small trial , iv-d after asah was feasible , tolerable and safe .", "http://clinicaltrials.gov nct@ ." ]
dantrolene is neuroprotective in animal models and may attenuate cerebral vasospasm ( cvsp ) in human aneurysmal subarachnoid haemorrhage ( asah ) . we evaluated safety , feasibility and tolerability of intravenous dantrolene ( iv-d ) in patients with asah . in this single-centre , randomised , double blind , placebo-controlled trial , @ patients with asah were randomised to iv-d @ mg every @h for @days ( n = @ ) or equiosmolar free water/@ % mannitol ( placebo ; n = @ ) . primary safety end points were incidence of hyponatraemia ( sna@mmol/l ) and liver toxicity ( proportion of patients alanine transaminase , aspartate aminotransferase and alkphos > @ upper-limit-of-normal ) . secondary end points included tolerability , systemic hypotension and intracranial hypertension . efficacy was explored for clinical/radiological cvsp , delayed cerebral ischaemia ( dci ) , and @-month functional outcomes . quantitative analyses of angiograms and daily transcranial doppler ( tcd ) were performed . between iv-d versus placebo , no differences were observed in the primary outcomes ( hyponatremia @ % vs @ % ( p = @ ) ; liver toxicity @ % vs @ % ( p = @ ) ) . three patients in the iv-d versus two in the placebo group had severe adverse events possibly attributable to infusion and reached stop criteria : one iv-d patient developed liver toxicity ; two patients in each group developed brain oedema requiring osmotherapy . the majority of adverse events were not related to infusion ( @ vs @ ( rr @ ; @ % ci @ to @ ; p = @ ) in iv-d vs placebo ) . no differences in any categorical cvsp outcomes , dci , @-month outcomes or quantitative angiogram and tcd analyses were seen in this small safety trial not powered to detect efficacy . in this small trial , iv-d after asah was feasible , tolerable and safe . http://clinicaltrials.gov nct@ .
25,344,064
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]
[ "antithyroid drug therapy is one of the main medical treatments for graves ' disease .", "there have been conflicting reports as to whether the addition of exogenous l-thyroxine improves remission rates more than antithyroid drugs alone .", "this randomized , controlled and prospective clinical trial was undertaken to investigate the long-term outcome of methimazole treatment with or without exogenous l-thyroxine in chinese patients .", "@ patients with graves ' disease were randomly divided into @ groups and all patients initially received @mg of methimazole daily for at least @ month and then followed the titration - regimen with or without l-thyroxine : group @ ( @mg@mg@mg@mg@mg ) ; group @ ( @mg@mg@mg@mg + l-thyroxine@mg + l-thyroxine ) ; group @ ( @mg@mg@mg@mg + l-thyroxine@mg + l-thyroxine@ @ mg + l-thyroxine ) .", "the drug therapy was discontinued after @ months of the final dose .", "@ out of @ patients in group @ ( @ % ) , @ out of @ in group @ ( @ % ) and @ out of @ in group @ ( @ % ) had a recurrence of graves ' disease within @-year follow-up after drug withdrawal .", "survival analysis showed no significant differences in the remission rates between any @ groups , despite the remission rates in group @ and @ were slightly higher than that in group @ .", "the addition of l-thyroxine to methimazole treatment in patients with graves ' disease neither improves nor prevents the remission or recurrence of graves ' disease in china ." ]
antithyroid drug therapy is one of the main medical treatments for graves ' disease . there have been conflicting reports as to whether the addition of exogenous l-thyroxine improves remission rates more than antithyroid drugs alone . this randomized , controlled and prospective clinical trial was undertaken to investigate the long-term outcome of methimazole treatment with or without exogenous l-thyroxine in chinese patients . @ patients with graves ' disease were randomly divided into @ groups and all patients initially received @mg of methimazole daily for at least @ month and then followed the titration - regimen with or without l-thyroxine : group @ ( @mg@mg@mg@mg@mg ) ; group @ ( @mg@mg@mg@mg + l-thyroxine@mg + l-thyroxine ) ; group @ ( @mg@mg@mg@mg + l-thyroxine@mg + l-thyroxine@ @ mg + l-thyroxine ) . the drug therapy was discontinued after @ months of the final dose . @ out of @ patients in group @ ( @ % ) , @ out of @ in group @ ( @ % ) and @ out of @ in group @ ( @ % ) had a recurrence of graves ' disease within @-year follow-up after drug withdrawal . survival analysis showed no significant differences in the remission rates between any @ groups , despite the remission rates in group @ and @ were slightly higher than that in group @ . the addition of l-thyroxine to methimazole treatment in patients with graves ' disease neither improves nor prevents the remission or recurrence of graves ' disease in china .
25,140,995
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "effective treatment for hepatitis c virus ( hcv ) genotype @ infection in patients who have not had a sustained virologic response to prior interferon-based therapy represents an unmet medical need .", "we conducted a phase @ , randomized , open-label study involving patients infected with hcv genotype @ who had not had a sustained virologic response after treatment with peginterferon and ribavirin , with or without a protease inhibitor .", "patients were randomly assigned to receive the ns@a inhibitor ledipasvir and the nucleotide polymerase inhibitor sofosbuvir in a once-daily , fixed-dose combination tablet for @ weeks , ledipasvir-sofosbuvir plus ribavirin for @ weeks , ledipasvir-sofosbuvir for @ weeks , or ledipasvir-sofosbuvir plus ribavirin for @ weeks .", "the primary end point was a sustained virologic response at @ weeks after the end of therapy .", "among the @ patients who underwent randomization and were treated , @ % had cirrhosis and @ % had hcv genotype @a infection .", "the rates of sustained virologic response were high in all treatment groups : @ % ( @ % confidence interval -lsb- ci -rsb- , @ to @ ) in the group that received @ weeks of ledipasvir-sofosbuvir ; @ % ( @ % ci , @ to @ ) in the group that received @ weeks of ledipasvir-sofosbuvir and ribavirin ; @ % ( @ % ci , @ to @ ) in the group that received @ weeks of ledipasvir-sofosbuvir ; and @ % ( @ % ci , @ to @ ) in the group that received @ weeks of ledipasvir-sofosbuvir and ribavirin .", "no patient discontinued treatment owing to an adverse event .", "the most common adverse events were fatigue , headache , and nausea .", "treatment with a once-daily , single-tablet regimen of ledipasvir and sofosbuvir resulted in high rates of sustained virologic response among patients with hcv genotype @ infection who had not had a sustained virologic response to prior interferon-based treatment .", "( funded by gilead sciences ; ion-@ clinicaltrials.gov number , nct@ . )" ]
effective treatment for hepatitis c virus ( hcv ) genotype @ infection in patients who have not had a sustained virologic response to prior interferon-based therapy represents an unmet medical need . we conducted a phase @ , randomized , open-label study involving patients infected with hcv genotype @ who had not had a sustained virologic response after treatment with peginterferon and ribavirin , with or without a protease inhibitor . patients were randomly assigned to receive the ns@a inhibitor ledipasvir and the nucleotide polymerase inhibitor sofosbuvir in a once-daily , fixed-dose combination tablet for @ weeks , ledipasvir-sofosbuvir plus ribavirin for @ weeks , ledipasvir-sofosbuvir for @ weeks , or ledipasvir-sofosbuvir plus ribavirin for @ weeks . the primary end point was a sustained virologic response at @ weeks after the end of therapy . among the @ patients who underwent randomization and were treated , @ % had cirrhosis and @ % had hcv genotype @a infection . the rates of sustained virologic response were high in all treatment groups : @ % ( @ % confidence interval -lsb- ci -rsb- , @ to @ ) in the group that received @ weeks of ledipasvir-sofosbuvir ; @ % ( @ % ci , @ to @ ) in the group that received @ weeks of ledipasvir-sofosbuvir and ribavirin ; @ % ( @ % ci , @ to @ ) in the group that received @ weeks of ledipasvir-sofosbuvir ; and @ % ( @ % ci , @ to @ ) in the group that received @ weeks of ledipasvir-sofosbuvir and ribavirin . no patient discontinued treatment owing to an adverse event . the most common adverse events were fatigue , headache , and nausea . treatment with a once-daily , single-tablet regimen of ledipasvir and sofosbuvir resulted in high rates of sustained virologic response among patients with hcv genotype @ infection who had not had a sustained virologic response to prior interferon-based treatment . ( funded by gilead sciences ; ion-@ clinicaltrials.gov number , nct@ . )
24,725,238
[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "we conducted a qualitative investigation of patients with type @ diabetes to determine their perceived facilitators and barriers to exercise at multiple time points while enrolled in a randomized exercise trial including aerobic , resistance or combined exercise .", "we explored differences in these themes over time , between intervention groups and by adherence level after intervention .", "interviews were conducted by telephone at @ weeks ( run-in period ) , and at @ ( midintervention ) , @ ( end of intervention ) and @ months ( maintenance ) after enrollment to assess factors that facilitated and hampered adherence to the exercise program .", "audiotapes were transcribed verbatim and subjected to content analysis .", "participants ( n = @ ) with type @ diabetes engaged in the interviews .", "social support from family and the trainer , future health benefits , a sense of well-being and perceived fitness improvements were exercise facilitators .", "experiencing illness or injury , work commitments and inclement weather were highlighted barriers .", "a sense of well-being , fitness improvements and enjoyment frequently were expressed by participants assigned to the combined and resistance exercise conditions .", "participants who maintained prescribed exercise levels tended to be engaged in resistance exercise , and spoke of support from their personal trainers , the importance of strategies and enjoyment more frequently than those who did not maintain their exercise level .", "exercise maintainers also cited more facilitators ; no differences were found for barriers .", "patients with type @ diabetes require social support , including continued contact with exercise specialists .", "patients need assistance with motivational enhancement and strategies to increase facilitators to maintain exercise behaviour .", "incorporating resistance exercise improves well-being and enjoyment-@ important factors linked to exercise maintenance ." ]
we conducted a qualitative investigation of patients with type @ diabetes to determine their perceived facilitators and barriers to exercise at multiple time points while enrolled in a randomized exercise trial including aerobic , resistance or combined exercise . we explored differences in these themes over time , between intervention groups and by adherence level after intervention . interviews were conducted by telephone at @ weeks ( run-in period ) , and at @ ( midintervention ) , @ ( end of intervention ) and @ months ( maintenance ) after enrollment to assess factors that facilitated and hampered adherence to the exercise program . audiotapes were transcribed verbatim and subjected to content analysis . participants ( n = @ ) with type @ diabetes engaged in the interviews . social support from family and the trainer , future health benefits , a sense of well-being and perceived fitness improvements were exercise facilitators . experiencing illness or injury , work commitments and inclement weather were highlighted barriers . a sense of well-being , fitness improvements and enjoyment frequently were expressed by participants assigned to the combined and resistance exercise conditions . participants who maintained prescribed exercise levels tended to be engaged in resistance exercise , and spoke of support from their personal trainers , the importance of strategies and enjoyment more frequently than those who did not maintain their exercise level . exercise maintainers also cited more facilitators ; no differences were found for barriers . patients with type @ diabetes require social support , including continued contact with exercise specialists . patients need assistance with motivational enhancement and strategies to increase facilitators to maintain exercise behaviour . incorporating resistance exercise improves well-being and enjoyment-@ important factors linked to exercise maintenance .
24,321,716
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "danshen ( salvia miltiorrhiza ) and gegen ( radix puerariae ) ( d&g ) are two herbs frequently used for the treatment of angina and other cardiac symptoms in chinese materia medica .", "recent studies have demonstrated their cardio-protective and anti-atherosclerosis effects .", "earlier we have conducted two clinical trials in @ and @ which demonstrated such effects in extremely high risk patients .", "the aim of the study was to demonstrate the safety and effectiveness of d&g in the prevention of atherosclerosis in postmenopausal women with early hypercholesterolemia .", "the study was designed as a randomized , double-blinded , placebo-controlled trial with a @-month treatment period .", "a population based sample of @ postmenopausal women aged @-@ were included in the trial .", "only women who experienced menopause for more than @ months were recruited .", "the eligible subjects were randomized to take the d&g preparation ( two capsules ) , or image-identical placebo capsules ( two capsules ) daily , in a double-blind and parallel fashion for @ month .", "the postmenopausal women with mild hypercholesterolemia ( mean age @ @ of treatment group and @ @ years of placebo group ) were randomized to the d&g group or placebo group for trial treatment .", "carotid intima-media thickness ( imt ) was used as the surrogate marker and was measured using high resolution ultrasound .", "lipid profile was also tested .", "baseline characteristics were comparable between the two groups .", "after @ months , there were no significant changes in the blood pressures and general biochemical profiles in both groups , however , there was a remarkable decrease in serum low density lipoprotein ( ldl ) cholesterol ( -@ % ) and total cholesterol ( tc ) ( -@ % ) in the d&g group compared with the placebo group ( -@ % and -@ % ) when compared with the baseline .", "the carotid intima-media thickness ( imt ) decreased @ % from baseline in the d&g group ( p < @ ) but the decrease was only @ % in the placebo treatment group ( p = @ ) after @ months treatment .", "twelve adverse events were reported ( six in placebo group and six in d&g group ) but none of them was directly relevant to the study herbal preparation .", "postmenopausal women with early hypercholesterolemia tolerated d&g well .", "d&g improved the carotid intima thickness , lowered ldl and total cholesterol .", "d&g therefore can be recommended for the prevention of atherosclerosis in postmenopausal women with hypercholesterolemia ." ]
danshen ( salvia miltiorrhiza ) and gegen ( radix puerariae ) ( d&g ) are two herbs frequently used for the treatment of angina and other cardiac symptoms in chinese materia medica . recent studies have demonstrated their cardio-protective and anti-atherosclerosis effects . earlier we have conducted two clinical trials in @ and @ which demonstrated such effects in extremely high risk patients . the aim of the study was to demonstrate the safety and effectiveness of d&g in the prevention of atherosclerosis in postmenopausal women with early hypercholesterolemia . the study was designed as a randomized , double-blinded , placebo-controlled trial with a @-month treatment period . a population based sample of @ postmenopausal women aged @-@ were included in the trial . only women who experienced menopause for more than @ months were recruited . the eligible subjects were randomized to take the d&g preparation ( two capsules ) , or image-identical placebo capsules ( two capsules ) daily , in a double-blind and parallel fashion for @ month . the postmenopausal women with mild hypercholesterolemia ( mean age @ @ of treatment group and @ @ years of placebo group ) were randomized to the d&g group or placebo group for trial treatment . carotid intima-media thickness ( imt ) was used as the surrogate marker and was measured using high resolution ultrasound . lipid profile was also tested . baseline characteristics were comparable between the two groups . after @ months , there were no significant changes in the blood pressures and general biochemical profiles in both groups , however , there was a remarkable decrease in serum low density lipoprotein ( ldl ) cholesterol ( -@ % ) and total cholesterol ( tc ) ( -@ % ) in the d&g group compared with the placebo group ( -@ % and -@ % ) when compared with the baseline . the carotid intima-media thickness ( imt ) decreased @ % from baseline in the d&g group ( p < @ ) but the decrease was only @ % in the placebo treatment group ( p = @ ) after @ months treatment . twelve adverse events were reported ( six in placebo group and six in d&g group ) but none of them was directly relevant to the study herbal preparation . postmenopausal women with early hypercholesterolemia tolerated d&g well . d&g improved the carotid intima thickness , lowered ldl and total cholesterol . d&g therefore can be recommended for the prevention of atherosclerosis in postmenopausal women with hypercholesterolemia .
24,906,587
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to investigate the effect of creatine ( cr ) supplementation on the acute interference induced by aerobic exercise on subsequent maximum dynamic strength ( @rm ) and strength endurance ( se , total number of repetitions ) performance .", "thirty-two recreationally strength-trained men were submitted to a graded exercise test to determine maximal oxygen consumption ( vo@max : @ @ ml kg ( -@ ) min ( -@ ) ) , anaerobic threshold velocity ( atv : @ @ km h ( -@ ) ) , and baseline performance ( control ) on the @rm and se ( @ @ % @rm to failure ) tests .", "after the control tests , participants were randomly assigned to either a cr ( @ g day ( -@ ) for @ days followed by @ g day ( -@ ) throughout the study ) or a placebo ( pl-dextrose ) group , and then completed @ experimental sessions , consisting of a @-km run on a treadmill either continuously ( @ % atv ) or intermittently ( @:@ min at vvo@max ) followed by either a leg - or bench-press se/@rm test .", "cr was able to maintain the leg-press se performance after the intermittent aerobic exercise when compared with c ( p > @ ) .", "on the other hand , the pl group showed a significant decrease in leg-press se ( p @ ) .", "cr supplementation significantly increased bench-press se after both aerobic exercise modes , while the bench-press se was not affected by either mode of aerobic exercise in the pl group .", "although small increases in @rm were observed after either continuous ( bench press and leg press ) or intermittent ( bench press ) aerobic exercise in the cr group , they were within the range of variability of the measurement .", "the pl group only maintained their @rm .", "in conclusion , the acute interference effect on strength performance observed in concurrent exercise may be counteracted by cr supplementation ." ]
to investigate the effect of creatine ( cr ) supplementation on the acute interference induced by aerobic exercise on subsequent maximum dynamic strength ( @rm ) and strength endurance ( se , total number of repetitions ) performance . thirty-two recreationally strength-trained men were submitted to a graded exercise test to determine maximal oxygen consumption ( vo@max : @ @ ml kg ( -@ ) min ( -@ ) ) , anaerobic threshold velocity ( atv : @ @ km h ( -@ ) ) , and baseline performance ( control ) on the @rm and se ( @ @ % @rm to failure ) tests . after the control tests , participants were randomly assigned to either a cr ( @ g day ( -@ ) for @ days followed by @ g day ( -@ ) throughout the study ) or a placebo ( pl-dextrose ) group , and then completed @ experimental sessions , consisting of a @-km run on a treadmill either continuously ( @ % atv ) or intermittently ( @:@ min at vvo@max ) followed by either a leg - or bench-press se/@rm test . cr was able to maintain the leg-press se performance after the intermittent aerobic exercise when compared with c ( p > @ ) . on the other hand , the pl group showed a significant decrease in leg-press se ( p @ ) . cr supplementation significantly increased bench-press se after both aerobic exercise modes , while the bench-press se was not affected by either mode of aerobic exercise in the pl group . although small increases in @rm were observed after either continuous ( bench press and leg press ) or intermittent ( bench press ) aerobic exercise in the cr group , they were within the range of variability of the measurement . the pl group only maintained their @rm . in conclusion , the acute interference effect on strength performance observed in concurrent exercise may be counteracted by cr supplementation .
24,840,857
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "nasogastric rehydration therapy ( ngrt ) is the recommended therapy in moderately dehydrated children with gastroenteritis and refusal to drink , since it is supposed to be as effective if not better than intravenous rehydration therapy ( ivrt ) .", "however , in clinical practice ivrt is often favored .", "we conducted a clinical trial to determine whether ivrt is not inferior to ngrt .", "children @ months to @ years of age with moderate dehydration and refusal to drink secondary to gastroenteritis were recruited .", "after clinical assessment of the degree of dehydration , patients were assigned randomly to receive either ivrt or ngrt over @h on the hospital ward .", "recruitment did not yield the estimated number of patients .", "mainly , non-enrollment was due to failure to obtain parental consent because ivrt was expected .", "@ patients were enrolled in the study , @ were randomized to ngrt and @ to ivrt .", "there was no difference between ivrt and ngrt groups concerning length of hospital stay ( @ days vs. @ days ) , success of rehydration ( @ vs. @ % ) and adverse events .", "since we had to terminate the study ahead of schedule due to a low recruiting rate , our results are not reliable .", "however , data from the literature shows that the widespread described superiority of ngrt over ivrt is seriously influenced by studies from developing countries questioning the applicability of the results to a setting available in high-income countries nowadays .", "our study demonstrates the difficulties performing such a study in a high-income country to come to an objective and clearly evident final conclusion ." ]
nasogastric rehydration therapy ( ngrt ) is the recommended therapy in moderately dehydrated children with gastroenteritis and refusal to drink , since it is supposed to be as effective if not better than intravenous rehydration therapy ( ivrt ) . however , in clinical practice ivrt is often favored . we conducted a clinical trial to determine whether ivrt is not inferior to ngrt . children @ months to @ years of age with moderate dehydration and refusal to drink secondary to gastroenteritis were recruited . after clinical assessment of the degree of dehydration , patients were assigned randomly to receive either ivrt or ngrt over @h on the hospital ward . recruitment did not yield the estimated number of patients . mainly , non-enrollment was due to failure to obtain parental consent because ivrt was expected . @ patients were enrolled in the study , @ were randomized to ngrt and @ to ivrt . there was no difference between ivrt and ngrt groups concerning length of hospital stay ( @ days vs. @ days ) , success of rehydration ( @ vs. @ % ) and adverse events . since we had to terminate the study ahead of schedule due to a low recruiting rate , our results are not reliable . however , data from the literature shows that the widespread described superiority of ngrt over ivrt is seriously influenced by studies from developing countries questioning the applicability of the results to a setting available in high-income countries nowadays . our study demonstrates the difficulties performing such a study in a high-income country to come to an objective and clearly evident final conclusion .
24,435,788
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the aim of this study was to compare radiological results of total knee arthroplasties ( tkas ) performed with patient-specific computed tomography ( ct ) - based instrumentation and conventional technique .", "the main study hypothesis was that ct-based patient-specific instrumentation ( psi ) increases the accuracy of tka .", "a prospective , randomized controlled trial was carried out between january and december @ .", "a group of @ patients who met the inclusion and exclusion criteria were enrolled in this study and randomly assigned to an experimental or control group .", "the experimental group comprised @ patients operated on with the aid of the signature ct-based implant positioning system .", "the control group consisted of @ patients operated on using conventional instrumentation .", "the radiographic evaluation of implant positioning and overall coronal alignment was performed @ months after the surgery by using standing anteroposterior radiographs of the entire lower limb and standard lateral radiographs .", "of the @ patients initially enrolled for the study , @ were included in the subsequent analyses .", "there were no statistically significant differences between groups in respect to coronal and sagittal component positioning and overall coronal alignment , except for frontal tibial component positioning .", "for this parameter , better results were obtained in the control group , with borderline statistical significance .", "our study did not reveal superiority of the ct-based psi system over conventional instrumentation .", "further high-quality investigations of patient-specific systems are absolutely indispensable to assess their utility for tka .", "in our opinion , the surgeon applying psi technology is required to have advanced knowledge and considerable experience with the conventional method ." ]
the aim of this study was to compare radiological results of total knee arthroplasties ( tkas ) performed with patient-specific computed tomography ( ct ) - based instrumentation and conventional technique . the main study hypothesis was that ct-based patient-specific instrumentation ( psi ) increases the accuracy of tka . a prospective , randomized controlled trial was carried out between january and december @ . a group of @ patients who met the inclusion and exclusion criteria were enrolled in this study and randomly assigned to an experimental or control group . the experimental group comprised @ patients operated on with the aid of the signature ct-based implant positioning system . the control group consisted of @ patients operated on using conventional instrumentation . the radiographic evaluation of implant positioning and overall coronal alignment was performed @ months after the surgery by using standing anteroposterior radiographs of the entire lower limb and standard lateral radiographs . of the @ patients initially enrolled for the study , @ were included in the subsequent analyses . there were no statistically significant differences between groups in respect to coronal and sagittal component positioning and overall coronal alignment , except for frontal tibial component positioning . for this parameter , better results were obtained in the control group , with borderline statistical significance . our study did not reveal superiority of the ct-based psi system over conventional instrumentation . further high-quality investigations of patient-specific systems are absolutely indispensable to assess their utility for tka . in our opinion , the surgeon applying psi technology is required to have advanced knowledge and considerable experience with the conventional method .
24,968,788
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "previous studies on the prognostic value of clinical and mri parameters for the time to return to play ( ttrtp ) in acute hamstring injuries showed only limited to moderate evidence for the various investigated parameters .", "some studies had multiple methodological limitations , including retrospective designs and the use of univariate analysis only .", "the aim of this study was to assess the prognostic value of clinical and mri parameters for ttrtp using multivariate analysis .", "@ clinical and mri parameters were prospectively investigated for an association with ttrtp in @ non-professional athletes with mri positive hamstring injuries undergoing a standardised rehabilitation programme .", "the association between possible prognostic parameters and ttrtp was assessed with a multivariate linear regression model .", "parameters that had a p value < @ on univariate testing were included in this model .", "@ athletes were available for analysis .", "a total of nine variables met the criteria for the multivariate analysis : intensity of sports , level of sports , self-predicted ttrtp by the athlete , length of discomfort on palpation , deficit in passive straight leg raise , pain score on isometric knee flexion , isometric knee flexion strength deficit and distance of the proximal pole of the mri hyperintensity to the tuber ischiadicum .", "of these , only self-predicted ttrtp by the athlete and a passive straight leg raise deficit remained significantly associated with ttrtp after stepwise logistic regression .", "the clinical parameters self-predicted ttrtp and passive straight leg raise deficit are independently associated with the ttrtp .", "mri parameters in grade @ and @ hamstring injuries , as described in the literature , are not associated with ttrtp .", "for clinical practice , prognosis of the ttrtp in these injuries should better be based on clinical parameters ." ]
previous studies on the prognostic value of clinical and mri parameters for the time to return to play ( ttrtp ) in acute hamstring injuries showed only limited to moderate evidence for the various investigated parameters . some studies had multiple methodological limitations , including retrospective designs and the use of univariate analysis only . the aim of this study was to assess the prognostic value of clinical and mri parameters for ttrtp using multivariate analysis . @ clinical and mri parameters were prospectively investigated for an association with ttrtp in @ non-professional athletes with mri positive hamstring injuries undergoing a standardised rehabilitation programme . the association between possible prognostic parameters and ttrtp was assessed with a multivariate linear regression model . parameters that had a p value < @ on univariate testing were included in this model . @ athletes were available for analysis . a total of nine variables met the criteria for the multivariate analysis : intensity of sports , level of sports , self-predicted ttrtp by the athlete , length of discomfort on palpation , deficit in passive straight leg raise , pain score on isometric knee flexion , isometric knee flexion strength deficit and distance of the proximal pole of the mri hyperintensity to the tuber ischiadicum . of these , only self-predicted ttrtp by the athlete and a passive straight leg raise deficit remained significantly associated with ttrtp after stepwise logistic regression . the clinical parameters self-predicted ttrtp and passive straight leg raise deficit are independently associated with the ttrtp . mri parameters in grade @ and @ hamstring injuries , as described in the literature , are not associated with ttrtp . for clinical practice , prognosis of the ttrtp in these injuries should better be based on clinical parameters .
25,037,199
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "effective o@ delivery and accurate end-tidal co@ ( etco@ ) sampling are essential features of nasal cannulae ( ncs ) in patients with compromised respiratory status .", "we studied @ nc designs : bifurcated nasal prongs ( nps ) with o@ delivery and co@ sensing in both nps ( hudson ) , separate o@/co@ nps ( salter ) , and co@ sensing in nps with cloud o@ delivery outside the nps via multi vents ( oridion ) and dual vents ( medline ) .", "we hypothesized that design differences between ncs would influence o@ delivery and etco@ detection .", "forty-five healthy volunteers , @ to @ years , participated in an unrestricted , randomized block design , each subject serving as their own control in a @-period crossover study design of @ ncs during one session .", "monitoring included electrocardiogram , posterior pharynx o@ sampling from a hauge airway ( sharn anesthesia products , tampa , fl ) , and nc etco@ .", "in @ volunteers , radial artery blood was sampled from a catheter for partial pressures of o@ and carbon dioxide ( pao@ and paco@ ) determination .", "per randomization , each nc was positioned , and data were collected over @ minutes ( etco@ , pharyngeal o@ , pao@ , and paco@ ) during room air and during o@ fresh gas flows ( fgfs ) of @ , @ , and @ lpm .", "statistical analyses were performed with sas analytics pro , version @ , and jmp statistical software , version @ ( sas institute inc. , cary , nc ) , significance at p < @ .", "blood gas analyses indicated paco@ during steady state at each experimental time period remained unchanged from physiologic baseline .", "pao@ did not differ between nc devices at baseline or @ lpm o@ .", "the pao@ at @ lpm from the separate nps and bifurcated ncs was significantly higher than the multi-vented nc .", "pharyngeal o@ with the nc with separate nps was significantly higher than multivented and dual-vented cloud delivery ncs at @ , @ , and @ lpm fgf .", "pharyngeal o@ with the nc with bifurcated nps was significantly higher than the multi-vented nc at @ lpm , and higher than cloud delivery ncs at @ and @ lpm fgf .", "etco@ was significantly lower with the nc with bifurcated nps compared to the other @ ncs , consistent with errant co@ tracings at higher fgf .", "ncs provide supplemental inspired o@ concentrations for patients with impaired pulmonary function .", "accurate measures of etco@ are helpful in assessing respiratory rate and determining whether co@ retention is occurring from hypoventilation .", "these findings suggest the nc with separate nps was the most effective in delivering o@ and the most consistent at providing reliable co@ waveforms at higher fgfs ." ]
effective o@ delivery and accurate end-tidal co@ ( etco@ ) sampling are essential features of nasal cannulae ( ncs ) in patients with compromised respiratory status . we studied @ nc designs : bifurcated nasal prongs ( nps ) with o@ delivery and co@ sensing in both nps ( hudson ) , separate o@/co@ nps ( salter ) , and co@ sensing in nps with cloud o@ delivery outside the nps via multi vents ( oridion ) and dual vents ( medline ) . we hypothesized that design differences between ncs would influence o@ delivery and etco@ detection . forty-five healthy volunteers , @ to @ years , participated in an unrestricted , randomized block design , each subject serving as their own control in a @-period crossover study design of @ ncs during one session . monitoring included electrocardiogram , posterior pharynx o@ sampling from a hauge airway ( sharn anesthesia products , tampa , fl ) , and nc etco@ . in @ volunteers , radial artery blood was sampled from a catheter for partial pressures of o@ and carbon dioxide ( pao@ and paco@ ) determination . per randomization , each nc was positioned , and data were collected over @ minutes ( etco@ , pharyngeal o@ , pao@ , and paco@ ) during room air and during o@ fresh gas flows ( fgfs ) of @ , @ , and @ lpm . statistical analyses were performed with sas analytics pro , version @ , and jmp statistical software , version @ ( sas institute inc. , cary , nc ) , significance at p < @ . blood gas analyses indicated paco@ during steady state at each experimental time period remained unchanged from physiologic baseline . pao@ did not differ between nc devices at baseline or @ lpm o@ . the pao@ at @ lpm from the separate nps and bifurcated ncs was significantly higher than the multi-vented nc . pharyngeal o@ with the nc with separate nps was significantly higher than multivented and dual-vented cloud delivery ncs at @ , @ , and @ lpm fgf . pharyngeal o@ with the nc with bifurcated nps was significantly higher than the multi-vented nc at @ lpm , and higher than cloud delivery ncs at @ and @ lpm fgf . etco@ was significantly lower with the nc with bifurcated nps compared to the other @ ncs , consistent with errant co@ tracings at higher fgf . ncs provide supplemental inspired o@ concentrations for patients with impaired pulmonary function . accurate measures of etco@ are helpful in assessing respiratory rate and determining whether co@ retention is occurring from hypoventilation . these findings suggest the nc with separate nps was the most effective in delivering o@ and the most consistent at providing reliable co@ waveforms at higher fgfs .
25,390,281
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "protein supplementation has been shown to reduce the increases in intrahepatic triglyceride ( ihtg ) content induced by acute hypercaloric high-fat and high-fructose diets in humans .", "to assess the effect of a @-wk iso-energetic high protein-low carbohydrate ( hplc ) diet compared with an iso-energetic high carbohydrate-low protein ( hclp ) diet on ihtg content in healthy non-obese subjects , at a constant body weight .", "seven men and nine women -lsb- mean sd age : @ @ y ; bmi : @ @ kg/m@ -rsb- were randomly allocated to a hplc -lsb- @/@/@ % of energy ( en % ) from protein/carbohydrate/fat -rsb- or a hclp ( @/@/@ en % ) diet by stratification on sex , age and bmi .", "dietary guidelines were prescribed based on individual daily energy requirements .", "ihtg content was measured by @h-magnetic resonance spectroscopy before and after the dietary intervention .", "ihtg content changed in different directions with the hplc ( ch@h@o : @ @ to @ @ ; ihtg % : @ @ % to @ @ % ) compared with the hclp diet ( ch@h@o : @ @ vs. @ @ ; ihtg % : @ @ % vs. @ @ % ) , which resulted in a lower ihtg content in the hplc compared with the hclp diet group after @ weeks , which almost reached statistical significance ( p = @ ) .", "a hplc vs. a hclp diet has the potential to preserve vs. enlarge ihtg content in healthy non-obese subjects at a constant body weight .", "clinicaltrials.gov nct@ ." ]
protein supplementation has been shown to reduce the increases in intrahepatic triglyceride ( ihtg ) content induced by acute hypercaloric high-fat and high-fructose diets in humans . to assess the effect of a @-wk iso-energetic high protein-low carbohydrate ( hplc ) diet compared with an iso-energetic high carbohydrate-low protein ( hclp ) diet on ihtg content in healthy non-obese subjects , at a constant body weight . seven men and nine women -lsb- mean sd age : @ @ y ; bmi : @ @ kg/m@ -rsb- were randomly allocated to a hplc -lsb- @/@/@ % of energy ( en % ) from protein/carbohydrate/fat -rsb- or a hclp ( @/@/@ en % ) diet by stratification on sex , age and bmi . dietary guidelines were prescribed based on individual daily energy requirements . ihtg content was measured by @h-magnetic resonance spectroscopy before and after the dietary intervention . ihtg content changed in different directions with the hplc ( ch@h@o : @ @ to @ @ ; ihtg % : @ @ % to @ @ % ) compared with the hclp diet ( ch@h@o : @ @ vs. @ @ ; ihtg % : @ @ % vs. @ @ % ) , which resulted in a lower ihtg content in the hplc compared with the hclp diet group after @ weeks , which almost reached statistical significance ( p = @ ) . a hplc vs. a hclp diet has the potential to preserve vs. enlarge ihtg content in healthy non-obese subjects at a constant body weight . clinicaltrials.gov nct@ .
25,330,327
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]
[ "we compared the clinical efficacy of barium therapy and conservative therapy in preventing recurrence in patients with diverticular bleeding .", "previous case reports have indicated that barium impaction therapy provides initial hemostasis for diverticular bleeding and prevention against rebleeding .", "after spontaneous cessation of bleeding , patients were randomly assigned to conservative treatment ( n = @ ) or high-dose barium impaction therapy ( n = @ ) .", "patients were followed up for @ year after enrollment of the last patient .", "the main outcome measure was rebleeding .", "median follow-up period was @ days .", "the probability of rebleeding at @-day , @-day , @-year , and @-year follow-up in all patients was @ % , @ % , @ % , and @ % , respectively .", "by group , probability at @ year was @ % in the conservative group and @ % in the barium group ( log-rank test , p = @ ) .", "after adjustment for a history of hypertension , the hazard ratio of rebleeding in the barium group was @ ( @ % confidence interval , @-@ @ ) .", "no complications or laboratory abnormalities due to barium therapy were observed .", "compared with the conservative group , the barium group had significantly ( p < @ ) fewer hospitalizations per patient ( @ vs @ ) , units of blood transfused ( @ vs @ ) , colonoscopies ( @ times vs @ times ) , and hospital stay days ( @ days vs @ days ) during the follow-up period .", "no patients died and none required angiographic or surgical procedures in either group .", "high-dose barium impaction therapy was effective in the long-term prevention of recurrent bleeding , and reduced the frequency of rehospitalization and need for blood transfusion and colonoscopic examination .", "clinicaltrials.gov identifier , umin @ ." ]
we compared the clinical efficacy of barium therapy and conservative therapy in preventing recurrence in patients with diverticular bleeding . previous case reports have indicated that barium impaction therapy provides initial hemostasis for diverticular bleeding and prevention against rebleeding . after spontaneous cessation of bleeding , patients were randomly assigned to conservative treatment ( n = @ ) or high-dose barium impaction therapy ( n = @ ) . patients were followed up for @ year after enrollment of the last patient . the main outcome measure was rebleeding . median follow-up period was @ days . the probability of rebleeding at @-day , @-day , @-year , and @-year follow-up in all patients was @ % , @ % , @ % , and @ % , respectively . by group , probability at @ year was @ % in the conservative group and @ % in the barium group ( log-rank test , p = @ ) . after adjustment for a history of hypertension , the hazard ratio of rebleeding in the barium group was @ ( @ % confidence interval , @-@ @ ) . no complications or laboratory abnormalities due to barium therapy were observed . compared with the conservative group , the barium group had significantly ( p < @ ) fewer hospitalizations per patient ( @ vs @ ) , units of blood transfused ( @ vs @ ) , colonoscopies ( @ times vs @ times ) , and hospital stay days ( @ days vs @ days ) during the follow-up period . no patients died and none required angiographic or surgical procedures in either group . high-dose barium impaction therapy was effective in the long-term prevention of recurrent bleeding , and reduced the frequency of rehospitalization and need for blood transfusion and colonoscopic examination . clinicaltrials.gov identifier , umin @ .
25,569,028
[ "OBJECTIVE", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "fiber intakes in developed countries are generally below those recommended by relevant authorities .", "given that many people consume fiber-depleted refined-grain products , adding functional fiber will help to increase fiber intakes .", "the objective of the study was to determine metabolic and sensory effects of adding fiber to bread .", "a double-blind pair of randomized crossover trials with a two-week washout in which two fiber-containing breads were compared with control bread .", "the functional fiber ( fruit fiber and fibremax ) was added to yield @ g fiber per serve ( two slices ) .", "eighty participants ( n = @ fruit fiber and n = @ fibremax ) consumed one serve of bread ( fiber or control ) followed three hours later by a pasta meal consumed ad libitum .", "outcome measures included glycemia , satiety , palatability , gastrointestinal wellbeing , visual appeal and subsequent energy intake of the pasta meal .", "multivariate regression was undertaken to test for differences between treatment and control for blood glucose , satiety , and cumulative energy intake .", "satiety responses were also compared by splitting the data into an immediate response after eating ( @-@ min ) and a return to hunger analysis ( @-@ min ) .", "a wilcoxon sign rank test was used for the first component ( @-@ min ) and wilcoxon matched-pairs signed-rank test for the second component ( @-@ min ) .", "between treatment differences for gastrointestinal wellbeing were tested using pearson 's chi-square test or fisher 's exact test .", "consumption of the fruit fiber bread reduced postprandial glycemia by @ % ( @ % ci @ to @ ; p = @ ) and cumulative energy intake by @ kj ( @ % ci @ to @ ; p = @ ) .", "there was little influence on satiety and the bread was rated as having poor taste and smell whilst generating feelings of nausea in some participants .", "fibremax enriched bread reduced glycemia by @ % ( @ % ci @ to @ ; p = @ ) without influence on energy intake or satiety .", "apart from a lower visual appeal , the fibremax bread was palatable .", "neither bread caused gastrointestinal discomfort related to flatulence or bloating .", "enriching bread with @ g of functional fiber per serve is feasible although reformulation is needed to create not only an acceptable bread , but a desirable product ." ]
fiber intakes in developed countries are generally below those recommended by relevant authorities . given that many people consume fiber-depleted refined-grain products , adding functional fiber will help to increase fiber intakes . the objective of the study was to determine metabolic and sensory effects of adding fiber to bread . a double-blind pair of randomized crossover trials with a two-week washout in which two fiber-containing breads were compared with control bread . the functional fiber ( fruit fiber and fibremax ) was added to yield @ g fiber per serve ( two slices ) . eighty participants ( n = @ fruit fiber and n = @ fibremax ) consumed one serve of bread ( fiber or control ) followed three hours later by a pasta meal consumed ad libitum . outcome measures included glycemia , satiety , palatability , gastrointestinal wellbeing , visual appeal and subsequent energy intake of the pasta meal . multivariate regression was undertaken to test for differences between treatment and control for blood glucose , satiety , and cumulative energy intake . satiety responses were also compared by splitting the data into an immediate response after eating ( @-@ min ) and a return to hunger analysis ( @-@ min ) . a wilcoxon sign rank test was used for the first component ( @-@ min ) and wilcoxon matched-pairs signed-rank test for the second component ( @-@ min ) . between treatment differences for gastrointestinal wellbeing were tested using pearson 's chi-square test or fisher 's exact test . consumption of the fruit fiber bread reduced postprandial glycemia by @ % ( @ % ci @ to @ ; p = @ ) and cumulative energy intake by @ kj ( @ % ci @ to @ ; p = @ ) . there was little influence on satiety and the bread was rated as having poor taste and smell whilst generating feelings of nausea in some participants . fibremax enriched bread reduced glycemia by @ % ( @ % ci @ to @ ; p = @ ) without influence on energy intake or satiety . apart from a lower visual appeal , the fibremax bread was palatable . neither bread caused gastrointestinal discomfort related to flatulence or bloating . enriching bread with @ g of functional fiber per serve is feasible although reformulation is needed to create not only an acceptable bread , but a desirable product .
25,066,659
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to investigate the efficacy and tolerability of albiglutide , a weekly glucagon-like peptide-@ receptor agonist , when added to metformin and glimepiride in a triple therapy regimen in people with type @ diabetes mellitus .", "this was a @-week , randomized , double-blind , parallel-group , multicentre study .", "in the present paper we describe the primary results , namely those at @weeks .", "adult participants ( n = @ ) were randomly assigned to albiglutide ( @mg/week ) , pioglitazone ( @mg/day ) or placebo .", "if needed , blinded uptitration of albiglutide ( to @mg/week ) and pioglitazone ( to @mg/day ) was allowed .", "the participant 's current dose of metformin ( > @mg/day ) was maintained throughout .", "the glimepiride dose ( @mg/day ) , standardized before randomization , could be decreased if persistent hypoglycaemia occurred .", "the week @ model-adjusted difference in change of glycated haemoglobin ( primary endpoint ) for albiglutide versus placebo was -@ -lsb- @ % confidence interval ( ci ) -@ , -@ -rsb- % - units ( p < @ ) , and for albiglutide versus pioglitazone it was @ ( @ % ci @ , @ ) % - units ; therefore , not non-inferior .", "in the albiglutide group only , fasting plasma glucose reduced rapidly in the first @weeks .", "confirmed hypoglycaemia occurred in @ % of participants on albiglutide , @ % on pioglitazone and @ % on placebo .", "the mean ( standard error ) weight change was -@ ( @ ) kg with albiglutide , +@ ( @ ) kg ( p < @ ) with pioglitazone , and -@ ( @ ) kg with placebo and serious adverse events occurred in @ , @ and @ % of participants in the respective groups .", "injection site reactions occurred in @ % of participants on albiglutide and resulted in treatment discontinuation for four participants ( @ % ) .", "albiglutide , as part of triple therapy , provided effective glucose-lowering and was generally well tolerated ." ]
to investigate the efficacy and tolerability of albiglutide , a weekly glucagon-like peptide-@ receptor agonist , when added to metformin and glimepiride in a triple therapy regimen in people with type @ diabetes mellitus . this was a @-week , randomized , double-blind , parallel-group , multicentre study . in the present paper we describe the primary results , namely those at @weeks . adult participants ( n = @ ) were randomly assigned to albiglutide ( @mg/week ) , pioglitazone ( @mg/day ) or placebo . if needed , blinded uptitration of albiglutide ( to @mg/week ) and pioglitazone ( to @mg/day ) was allowed . the participant 's current dose of metformin ( > @mg/day ) was maintained throughout . the glimepiride dose ( @mg/day ) , standardized before randomization , could be decreased if persistent hypoglycaemia occurred . the week @ model-adjusted difference in change of glycated haemoglobin ( primary endpoint ) for albiglutide versus placebo was -@ -lsb- @ % confidence interval ( ci ) -@ , -@ -rsb- % - units ( p < @ ) , and for albiglutide versus pioglitazone it was @ ( @ % ci @ , @ ) % - units ; therefore , not non-inferior . in the albiglutide group only , fasting plasma glucose reduced rapidly in the first @weeks . confirmed hypoglycaemia occurred in @ % of participants on albiglutide , @ % on pioglitazone and @ % on placebo . the mean ( standard error ) weight change was -@ ( @ ) kg with albiglutide , +@ ( @ ) kg ( p < @ ) with pioglitazone , and -@ ( @ ) kg with placebo and serious adverse events occurred in @ , @ and @ % of participants in the respective groups . injection site reactions occurred in @ % of participants on albiglutide and resulted in treatment discontinuation for four participants ( @ % ) . albiglutide , as part of triple therapy , provided effective glucose-lowering and was generally well tolerated .
25,406,730
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "irritable bowel syndrome with diarrhoea ( ibs-d ) is particularly debilitating due to urgency and episodic incontinence .", "some @-hydroxytryptamine @ ( @-ht@ ) receptor antagonists ( @-ht@ras ) have proven effective but have serious side effects .", "ondansetron , also a @-ht@ra , has been widely used as an antiemetic with an excellent safety record for over two decades .", "our aim was to assess its effectiveness in ibs-d .", "@ patients meeting rome iii criteria for ibs-d entered a randomised , double-blind , placebo-controlled crossover study of @weeks of ondansetron @mg versus placebo with dose titration allowed , up to two tablets three times daily in the first @weeks .", "patients completed daily diaries documenting stool consistency using the bristol stool form score .", "gut transit was measured in the last week of each treatment .", "the primary endpoint was average stool consistency in the last @weeks of treatment .", "ondansetron significantly improved stool consistency ( mean difference in stool form between ondansetron and placebo -@ , @ % ci -@ to -@ , p < @ ) .", "compared with placebo , patients on ondansetron experienced fewer days with urgency ( p < @ ) , lower urgency scores ( p < @ ) , reduced frequency of defaecation ( p = @ ) and less bloating ( p = @ ) , although pain scores did not change significantly .", "ibs symptom severity score fell more with ondansetron than placebo ( @ vs @ , p = @ ) .", "@ % reported adequate relief with ondansetron but not placebo compared with @ % reporting relief with placebo but not ondansetron , relative risk @ , @ % ci @ to @ , p < @ .", "ondansetron relieves some of the most intrusive symptoms of ibs-d , namely loose stools , frequency and urgency ." ]
irritable bowel syndrome with diarrhoea ( ibs-d ) is particularly debilitating due to urgency and episodic incontinence . some @-hydroxytryptamine @ ( @-ht@ ) receptor antagonists ( @-ht@ras ) have proven effective but have serious side effects . ondansetron , also a @-ht@ra , has been widely used as an antiemetic with an excellent safety record for over two decades . our aim was to assess its effectiveness in ibs-d . @ patients meeting rome iii criteria for ibs-d entered a randomised , double-blind , placebo-controlled crossover study of @weeks of ondansetron @mg versus placebo with dose titration allowed , up to two tablets three times daily in the first @weeks . patients completed daily diaries documenting stool consistency using the bristol stool form score . gut transit was measured in the last week of each treatment . the primary endpoint was average stool consistency in the last @weeks of treatment . ondansetron significantly improved stool consistency ( mean difference in stool form between ondansetron and placebo -@ , @ % ci -@ to -@ , p < @ ) . compared with placebo , patients on ondansetron experienced fewer days with urgency ( p < @ ) , lower urgency scores ( p < @ ) , reduced frequency of defaecation ( p = @ ) and less bloating ( p = @ ) , although pain scores did not change significantly . ibs symptom severity score fell more with ondansetron than placebo ( @ vs @ , p = @ ) . @ % reported adequate relief with ondansetron but not placebo compared with @ % reporting relief with placebo but not ondansetron , relative risk @ , @ % ci @ to @ , p < @ . ondansetron relieves some of the most intrusive symptoms of ibs-d , namely loose stools , frequency and urgency .
24,334,242
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "because many sports concussions happen during school-sponsored sports events , most state concussion laws specifically hold schools accountable for coach training and effective concussion management practices .", "brain @ : the concussion playbook is a web-based intervention that includes training in sports concussion for each member of the school community , presents guidelines on creating a concussion management team , and includes strategies for supporting students in the classroom .", "the group randomized controlled trial examined the efficacy of brain @ in managing sports concussion .", "participating high schools ( n = @ ) were randomly assigned to the brain @ intervention or control .", "fall athletes and their parents completed online training , and brain @ school administrators were directed to create concussion management policy and procedures .", "student athletes and parents at brain @ schools significantly outperformed those at control schools on sports concussion knowledge , knowledge application , and behavioral intention to implement effective concussion management practices .", "students who had concussions in brain @ schools received more varied academic accommodations than students in control schools .", "brain @ can help schools create a comprehensive schoolwide concussion management program .", "it requires minimal expenditures and offers engaging and effective education for teachers , coaches , parents , and students ." ]
because many sports concussions happen during school-sponsored sports events , most state concussion laws specifically hold schools accountable for coach training and effective concussion management practices . brain @ : the concussion playbook is a web-based intervention that includes training in sports concussion for each member of the school community , presents guidelines on creating a concussion management team , and includes strategies for supporting students in the classroom . the group randomized controlled trial examined the efficacy of brain @ in managing sports concussion . participating high schools ( n = @ ) were randomly assigned to the brain @ intervention or control . fall athletes and their parents completed online training , and brain @ school administrators were directed to create concussion management policy and procedures . student athletes and parents at brain @ schools significantly outperformed those at control schools on sports concussion knowledge , knowledge application , and behavioral intention to implement effective concussion management practices . students who had concussions in brain @ schools received more varied academic accommodations than students in control schools . brain @ can help schools create a comprehensive schoolwide concussion management program . it requires minimal expenditures and offers engaging and effective education for teachers , coaches , parents , and students .
25,438,964
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to evaluate the effects of canagliflozin , a sodium glucose co-transporter @ inhibitor , on body weight in overweight and obese subjects ( body mass index -lsb- bmi -rsb- @ and < @ kg/m ( @ ) ) .", "this @-week , phase @b , randomized , double-blind study enrolled @ subjects without diabetes mellitus who received canagliflozin @ , @ , or @ mg or placebo once daily .", "the primary endpoint was the percent change in body weight from baseline through week @ .", "canagliflozin increased urinary glucose excretion in a dose-dependent manner and produced statistically significant reductions in body weight compared with placebo ( least squares mean percent changes from baseline of -@ % , -@ % , -@ % , and -@ % with canagliflozin @ , @ , and @ mg and placebo ; p < @ for all comparisons ) .", "overall adverse event ( ae ) rates were similar across groups .", "canagliflozin was associated with higher rates of genital mycotic infections in women , which were generally mild and led to few study discontinuations .", "osmotic diuresis-related ae rates were low and similar across groups .", "in overweight and obese subjects without diabetes mellitus , canagliflozin significantly reduced body weight compared with placebo and was generally well tolerated ." ]
to evaluate the effects of canagliflozin , a sodium glucose co-transporter @ inhibitor , on body weight in overweight and obese subjects ( body mass index -lsb- bmi -rsb- @ and < @ kg/m ( @ ) ) . this @-week , phase @b , randomized , double-blind study enrolled @ subjects without diabetes mellitus who received canagliflozin @ , @ , or @ mg or placebo once daily . the primary endpoint was the percent change in body weight from baseline through week @ . canagliflozin increased urinary glucose excretion in a dose-dependent manner and produced statistically significant reductions in body weight compared with placebo ( least squares mean percent changes from baseline of -@ % , -@ % , -@ % , and -@ % with canagliflozin @ , @ , and @ mg and placebo ; p < @ for all comparisons ) . overall adverse event ( ae ) rates were similar across groups . canagliflozin was associated with higher rates of genital mycotic infections in women , which were generally mild and led to few study discontinuations . osmotic diuresis-related ae rates were low and similar across groups . in overweight and obese subjects without diabetes mellitus , canagliflozin significantly reduced body weight compared with placebo and was generally well tolerated .
24,227,660
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "there have been no data on sublingual immunotherapy ( slit ) in brazilian patients sensitized to house dust mites .", "this study aimed to evaluate the mucosal/systemic antibody response changes and clinical efficacy after slit using dermatophagoides pteronyssinus ( dpt ) allergens with or without bacterial extracts in mite-allergic brazilian children .", "patients with allergic rhinitis and asthma were selected for a double-blind , placebo-controlled trial randomized to three groups : dpt ( dpt extract , n = @ ) , dpt+mrb ( dpt plus mixed respiratory bacterial extracts , n = @ ) , and placebo ( n = @ ) .", "total symptom and medication scores for rhinitis/asthma , skin prick test ( spt ) to dpt , and measurements of dpt - , der p @ - , der p @-specific serum ige , igg@ , igg@ , and specific salivary iga were evaluated at baseline and after @ and @ months of treatment .", "a significant long-term decline in total symptom/medication scores was observed only in active groups ( dtp and dpt+mrb ) .", "there was no significant change in spt results in all groups .", "slit using dpt allergen alone induced increased levels of serum igg@ to dpt , der p @ , and der p @ , serum igg@ and salivary iga to dpt and der p @ .", "slit with dpt plus bacterial extracts was able to decrease ige levels , particularly to der p @ , to increase salivary iga levels to der p @ , but had no changes on specific igg@ and igg@ levels .", "all children undergoing slit showed clinical improvement , but a long-term reduction in symptom/medication scores with modulation of mucosal/systemic antibody responses were seen only in active groups ( dpt and dpt+mrb ) ." ]
there have been no data on sublingual immunotherapy ( slit ) in brazilian patients sensitized to house dust mites . this study aimed to evaluate the mucosal/systemic antibody response changes and clinical efficacy after slit using dermatophagoides pteronyssinus ( dpt ) allergens with or without bacterial extracts in mite-allergic brazilian children . patients with allergic rhinitis and asthma were selected for a double-blind , placebo-controlled trial randomized to three groups : dpt ( dpt extract , n = @ ) , dpt+mrb ( dpt plus mixed respiratory bacterial extracts , n = @ ) , and placebo ( n = @ ) . total symptom and medication scores for rhinitis/asthma , skin prick test ( spt ) to dpt , and measurements of dpt - , der p @ - , der p @-specific serum ige , igg@ , igg@ , and specific salivary iga were evaluated at baseline and after @ and @ months of treatment . a significant long-term decline in total symptom/medication scores was observed only in active groups ( dtp and dpt+mrb ) . there was no significant change in spt results in all groups . slit using dpt allergen alone induced increased levels of serum igg@ to dpt , der p @ , and der p @ , serum igg@ and salivary iga to dpt and der p @ . slit with dpt plus bacterial extracts was able to decrease ige levels , particularly to der p @ , to increase salivary iga levels to der p @ , but had no changes on specific igg@ and igg@ levels . all children undergoing slit showed clinical improvement , but a long-term reduction in symptom/medication scores with modulation of mucosal/systemic antibody responses were seen only in active groups ( dpt and dpt+mrb ) .
24,299,565
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the aim of this study was to test the hypothesis that intensive glycaemic control ( int ) and higher plasma c-peptide levels in patients with poorly controlled diabetes would be associated with better eye outcomes .", "the incidence and progression of diabetic retinopathy ( dr ) was assessed by grading seven-field stereoscopic fundus photographs at baseline and @ years later in @ of @,@ participants in the veterans affairs diabetes trial ( vadt ) .", "after adjustment for all covariates , risk of progression ( but not incidence ) of dr increased by @ % for each @ % increase in baseline hba@c ( or @ ; @ % ci @ , @ ; p = @ ) .", "neither assignment to int nor age was independently associated with dr in the entire cohort .", "however , int showed a biphasic interaction with age .", "the incidence of dr was decreased in int participants @ years of age ( or @ ; @ % ci @ , @ ) but increased in those @ years old ( or @ ; @ % ci @ , @ ) ( p = @ ) .", "the incidence of dr was reduced by @ % with each @ pmol/ml increment in baseline c-peptide ( or @ ; @ % ci @ , @ ; p = @ ) .", "baseline c-peptide was also an independent inverse risk factor for the progression of dr , with a reduction of @ % with each @ pmol/ml increase in c-peptide ( or @ ; @ % ci @ , @ ; p = @ ) .", "poor glucose control at baseline was associated with an increased risk of progression of dr. int was associated with a decreased incidence of dr in younger patients but with an increased risk of dr in older patients .", "higher c-peptide at baseline was associated with reduced incidence and progression of dr." ]
the aim of this study was to test the hypothesis that intensive glycaemic control ( int ) and higher plasma c-peptide levels in patients with poorly controlled diabetes would be associated with better eye outcomes . the incidence and progression of diabetic retinopathy ( dr ) was assessed by grading seven-field stereoscopic fundus photographs at baseline and @ years later in @ of @,@ participants in the veterans affairs diabetes trial ( vadt ) . after adjustment for all covariates , risk of progression ( but not incidence ) of dr increased by @ % for each @ % increase in baseline hba@c ( or @ ; @ % ci @ , @ ; p = @ ) . neither assignment to int nor age was independently associated with dr in the entire cohort . however , int showed a biphasic interaction with age . the incidence of dr was decreased in int participants @ years of age ( or @ ; @ % ci @ , @ ) but increased in those @ years old ( or @ ; @ % ci @ , @ ) ( p = @ ) . the incidence of dr was reduced by @ % with each @ pmol/ml increment in baseline c-peptide ( or @ ; @ % ci @ , @ ; p = @ ) . baseline c-peptide was also an independent inverse risk factor for the progression of dr , with a reduction of @ % with each @ pmol/ml increase in c-peptide ( or @ ; @ % ci @ , @ ; p = @ ) . poor glucose control at baseline was associated with an increased risk of progression of dr. int was associated with a decreased incidence of dr in younger patients but with an increased risk of dr in older patients . higher c-peptide at baseline was associated with reduced incidence and progression of dr.
24,599,110
[ "OBJECTIVE", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the need for long preoperative fasting has been questioned .", "recent data shows that intake of an oral carbohydrate-containing clear fluid prior to anaesthesia is safe and may have a positive impact on recovery and metabolic status and could improve glucose tolerance .", "such solutions are routinely used in adults but not children .", "the aim of this study was to evaluate the safety , tolerance and influence of oral carbohydrate on selected metabolic parameters in children .", "with ethics committee approval and parental informed consent , @ children , aged @-@ years , asa status i or ii , scheduled for abdominal or thoracic surgery were randomised either to group @ - receiving a @ % carbohydrate-containing drink ( @ ml kg ( -@ ) the evening before surgery and two hours before anaesthesia ) , or the control group @ - fasting .", "serum glucose and insulin concentration were measured four times : before and after anaesthesia , in the evening after surgery , and the following morning .", "igf-@ concentration was measured once , before surgery .", "insulin resistance was assessed by the homa-ir equation .", "oral carbohydrate solution was well tolerated and no adverse events were noted .", "glucose concentrations were within the normal range in both groups .", "insulin concentration did not show significant differences between groups , however before surgery it tended to be lower in group @ .", "insulin resistance after surgery was significantly higher in group @ ( @ vs. @ , p = @ ) , also the increase in insulin resistance after operation was significant only in the control group ( p = @ ) .", "oral carbohydrates are safe , well tolerated and do not cause any perioperative adverse events .", "they seem to improve postoperative metabolism by decreasing insulin resistance ." ]
the need for long preoperative fasting has been questioned . recent data shows that intake of an oral carbohydrate-containing clear fluid prior to anaesthesia is safe and may have a positive impact on recovery and metabolic status and could improve glucose tolerance . such solutions are routinely used in adults but not children . the aim of this study was to evaluate the safety , tolerance and influence of oral carbohydrate on selected metabolic parameters in children . with ethics committee approval and parental informed consent , @ children , aged @-@ years , asa status i or ii , scheduled for abdominal or thoracic surgery were randomised either to group @ - receiving a @ % carbohydrate-containing drink ( @ ml kg ( -@ ) the evening before surgery and two hours before anaesthesia ) , or the control group @ - fasting . serum glucose and insulin concentration were measured four times : before and after anaesthesia , in the evening after surgery , and the following morning . igf-@ concentration was measured once , before surgery . insulin resistance was assessed by the homa-ir equation . oral carbohydrate solution was well tolerated and no adverse events were noted . glucose concentrations were within the normal range in both groups . insulin concentration did not show significant differences between groups , however before surgery it tended to be lower in group @ . insulin resistance after surgery was significantly higher in group @ ( @ vs. @ , p = @ ) , also the increase in insulin resistance after operation was significant only in the control group ( p = @ ) . oral carbohydrates are safe , well tolerated and do not cause any perioperative adverse events . they seem to improve postoperative metabolism by decreasing insulin resistance .
24,858,963
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to investigate the effects of magnesium sulphate on succinylcholine-induced fasciculation in patients during the induction of general anaesthesia .", "the double-blind randomised clinical trial was conducted in @ at tohid and besat hospitals in sanandaj , iran , on patients who were candidates for surgery under general anaesthesia .", "patients were selected and divided into two equal groups of cases and controls using block randomisation .", "the cases received magnesium sulphate , while the controls received normal saline .", "spss @ was used for statistical analysis .", "of the @ subjects in the study , @ ( @ % ) were men and @ ( @ % ) were women ( p < @ ) .", "the mean age of the two groups were @ @ years and @ @ years ( p < @ ) .", "there was significant difference between the two groups in terms of the degree of fasciculation and muscle fasciculation ( p < @ ) .", "the difference between potassium levels in the two groups was not significant before anaesthesia ( p > @ ) , but it was significant after anaesthesia ( p < @ ) .", "magnesium sulphate can prevent and reduce the degree of fasciculation after anaesthesia .", "therefore it can be used to prevent fasciculation ." ]
to investigate the effects of magnesium sulphate on succinylcholine-induced fasciculation in patients during the induction of general anaesthesia . the double-blind randomised clinical trial was conducted in @ at tohid and besat hospitals in sanandaj , iran , on patients who were candidates for surgery under general anaesthesia . patients were selected and divided into two equal groups of cases and controls using block randomisation . the cases received magnesium sulphate , while the controls received normal saline . spss @ was used for statistical analysis . of the @ subjects in the study , @ ( @ % ) were men and @ ( @ % ) were women ( p < @ ) . the mean age of the two groups were @ @ years and @ @ years ( p < @ ) . there was significant difference between the two groups in terms of the degree of fasciculation and muscle fasciculation ( p < @ ) . the difference between potassium levels in the two groups was not significant before anaesthesia ( p > @ ) , but it was significant after anaesthesia ( p < @ ) . magnesium sulphate can prevent and reduce the degree of fasciculation after anaesthesia . therefore it can be used to prevent fasciculation .
25,823,155
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "schools provide a natural context to promote children 's mental health .", "however , there is a need for more evidence-based , high quality school intervention programs combined with an accurate evaluation of their general effectiveness and effectiveness of specific intervention methods .", "the aim of this paper is to present a study protocol of a cluster randomized controlled trial evaluating the `` together at school '' intervention program .", "the intervention program is designed to promote social-emotional skills and mental health by utilizing whole-school approach and focuses on classroom curriculum , work environment of school staff , and parent-teacher collaboration methods .", "the evaluation study examines the effects of the intervention on children 's socio-emotional skills and mental health in a cluster randomized controlled trial design with @ ) an intervention group and @ ) an active control group .", "altogether @ primary school participated at baseline .", "a multi-informant setting involves the children themselves , their parents , and teachers .", "the primary outcomes are measured using parent and teacher ratings of children 's socio-emotional skills and psychological problems measured by the strengths and difficulties questionnaire and the multisource assessment of social competence scale .", "secondary outcomes for the children include emotional understanding , altruistic behavior , and executive functions ( e.g. working memory , planning , and inhibition ) .", "secondary outcomes for the teachers include ratings of e.g. school environment , teaching style and well-being .", "secondary outcomes for both teachers and parents include e.g. emotional self-efficacy , child rearing practices , and teacher-parent collaboration .", "the data was collected at baseline ( autumn @ ) , @ months after baseline , and will be collected also @ months after baseline from the same participants .", "this study protocol outlines a trial which aims to add to the current state of intervention programs by presenting and studying a contextually developed and carefully tested intervention program which is tailored to fit a national school system .", "identification of effective intervention elements to promote children 's mental health in early school years is crucial for optimal later development .", "clinicaltrials.gov register : nct@ ." ]
schools provide a natural context to promote children 's mental health . however , there is a need for more evidence-based , high quality school intervention programs combined with an accurate evaluation of their general effectiveness and effectiveness of specific intervention methods . the aim of this paper is to present a study protocol of a cluster randomized controlled trial evaluating the `` together at school '' intervention program . the intervention program is designed to promote social-emotional skills and mental health by utilizing whole-school approach and focuses on classroom curriculum , work environment of school staff , and parent-teacher collaboration methods . the evaluation study examines the effects of the intervention on children 's socio-emotional skills and mental health in a cluster randomized controlled trial design with @ ) an intervention group and @ ) an active control group . altogether @ primary school participated at baseline . a multi-informant setting involves the children themselves , their parents , and teachers . the primary outcomes are measured using parent and teacher ratings of children 's socio-emotional skills and psychological problems measured by the strengths and difficulties questionnaire and the multisource assessment of social competence scale . secondary outcomes for the children include emotional understanding , altruistic behavior , and executive functions ( e.g. working memory , planning , and inhibition ) . secondary outcomes for the teachers include ratings of e.g. school environment , teaching style and well-being . secondary outcomes for both teachers and parents include e.g. emotional self-efficacy , child rearing practices , and teacher-parent collaboration . the data was collected at baseline ( autumn @ ) , @ months after baseline , and will be collected also @ months after baseline from the same participants . this study protocol outlines a trial which aims to add to the current state of intervention programs by presenting and studying a contextually developed and carefully tested intervention program which is tailored to fit a national school system . identification of effective intervention elements to promote children 's mental health in early school years is crucial for optimal later development . clinicaltrials.gov register : nct@ .
25,287,298
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "resuscitation is a life-saving measure usually instructed in simulation sessions .", "small-group teaching is effective .", "however , feasible group sizes for resuscitation classes are unknown .", "we investigated the impact of different group sizes on the outcome of resuscitation training .", "medical students ( n = @ ) were randomized to courses with three , five or eight participants per tutor .", "the course duration was adjusted according to the group size , so that there was a time slot of @ minutes hands-on time for every student .", "all participants performed an objective structured clinical examination before and after training .", "the teaching sessions were videotaped and resuscitation quality was scored using a checklist while we measured the chest compression parameters with a manikin .", "in addition , we recorded hands-on-time , questions to the tutor and unrelated conversation .", "results are displayed as median ( iqr ) .", "checklist pass rates and scores were comparable between the groups of three , five and eight students per tutor in the post-test ( @ % , @ % and @ % ) .", "groups of eight students asked fewer questions ( @ ( @ - @ ) vs. @ ( @ - @ ) , p < @ ) , had less hands-on time ( @:@ min ( @:@ - @:@ min ) vs. @:@ min ( @:@ - @:@ min ) , p = @ ) , conducted more unrelated conversations ( @ and @ , p < @ ) and had lower self-assessments than groups of three students per tutor ( @ ( @ - @ ) and @ ( @ - @ ) , p = @ ) .", "resuscitation checklist scores and pass rates after training were comparable in groups of three , five or eight medical students , although smaller groups had advantages in teaching interventions and hands-on time .", "our results suggest that teaching bls skills is effective in groups up to eight medical students , but smaller groups yielded more intense teaching conditions , which might be crucial for more complex skills or less advanced students ." ]
resuscitation is a life-saving measure usually instructed in simulation sessions . small-group teaching is effective . however , feasible group sizes for resuscitation classes are unknown . we investigated the impact of different group sizes on the outcome of resuscitation training . medical students ( n = @ ) were randomized to courses with three , five or eight participants per tutor . the course duration was adjusted according to the group size , so that there was a time slot of @ minutes hands-on time for every student . all participants performed an objective structured clinical examination before and after training . the teaching sessions were videotaped and resuscitation quality was scored using a checklist while we measured the chest compression parameters with a manikin . in addition , we recorded hands-on-time , questions to the tutor and unrelated conversation . results are displayed as median ( iqr ) . checklist pass rates and scores were comparable between the groups of three , five and eight students per tutor in the post-test ( @ % , @ % and @ % ) . groups of eight students asked fewer questions ( @ ( @ - @ ) vs. @ ( @ - @ ) , p < @ ) , had less hands-on time ( @:@ min ( @:@ - @:@ min ) vs. @:@ min ( @:@ - @:@ min ) , p = @ ) , conducted more unrelated conversations ( @ and @ , p < @ ) and had lower self-assessments than groups of three students per tutor ( @ ( @ - @ ) and @ ( @ - @ ) , p = @ ) . resuscitation checklist scores and pass rates after training were comparable in groups of three , five or eight medical students , although smaller groups had advantages in teaching interventions and hands-on time . our results suggest that teaching bls skills is effective in groups up to eight medical students , but smaller groups yielded more intense teaching conditions , which might be crucial for more complex skills or less advanced students .
25,194,168
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "urinary tract infection is a key issue for long-term intermittent catheterization users .", "various catheter designs and methods have evolved to decrease the risk but the evidence remains unclear regarding whether product type improves outcomes .", "we determined whether single use hydrophilic coated catheters reduced urinary tract infections compared to multiple use polyvinylchloride catheters for children with neurogenic bladder due to spina bifida .", "this was a randomized crossover @-center trial with @ treatment periods of @ weeks each , consisting of single use hydrophilic coated catheter and multiple use polyvinylchloride catheter ( washed with soap and water , and air dried after each use ) .", "each week participants recorded symptoms and urine results ( multistix @sg reagent strip ) .", "primary outcome was person-weeks of urinary tract infection , defined as positive leukocytes plus fever , flank pain , increased incontinence , malaise , or cloudy or odorous urine requiring antibiotic treatment .", "individuals were included if they were a child or young adult with spina bifida and used intermittent catheterization as the primary method of bladder emptying .", "calculated sample size was @ .", "more than @ patients were screened , of whom @ were randomized and @ completed both trial arms .", "mean age was @ years .", "of the patients @ were male and @ were female .", "mean sd person-weeks of urinary tract infection was @ @ in the single use hydrophilic coated catheter group and @ @ in the multiple use polyvinylchloride catheter group ( p < @ ) .", "there were no statistical differences in weeks of febrile urinary tract infection or antibiotic use .", "results are consistent with the cochrane review in that single use hydrophilic coated catheters may not decrease the incidence of symptomatic urinary tract infection in community dwelling chronic intermittent catheterization users when compared to clean multiple use polyvinylchloride catheters ." ]
urinary tract infection is a key issue for long-term intermittent catheterization users . various catheter designs and methods have evolved to decrease the risk but the evidence remains unclear regarding whether product type improves outcomes . we determined whether single use hydrophilic coated catheters reduced urinary tract infections compared to multiple use polyvinylchloride catheters for children with neurogenic bladder due to spina bifida . this was a randomized crossover @-center trial with @ treatment periods of @ weeks each , consisting of single use hydrophilic coated catheter and multiple use polyvinylchloride catheter ( washed with soap and water , and air dried after each use ) . each week participants recorded symptoms and urine results ( multistix @sg reagent strip ) . primary outcome was person-weeks of urinary tract infection , defined as positive leukocytes plus fever , flank pain , increased incontinence , malaise , or cloudy or odorous urine requiring antibiotic treatment . individuals were included if they were a child or young adult with spina bifida and used intermittent catheterization as the primary method of bladder emptying . calculated sample size was @ . more than @ patients were screened , of whom @ were randomized and @ completed both trial arms . mean age was @ years . of the patients @ were male and @ were female . mean sd person-weeks of urinary tract infection was @ @ in the single use hydrophilic coated catheter group and @ @ in the multiple use polyvinylchloride catheter group ( p < @ ) . there were no statistical differences in weeks of febrile urinary tract infection or antibiotic use . results are consistent with the cochrane review in that single use hydrophilic coated catheters may not decrease the incidence of symptomatic urinary tract infection in community dwelling chronic intermittent catheterization users when compared to clean multiple use polyvinylchloride catheters .
25,584,995
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "due to the negative impact of radiation on the patient and the surgical team during percutaneous nephrolithotomy ( pcnl ) , we aimed to evaluate success rate and complications of blind access for pcnl using lumbar notch landmark and compare with conventional fluoroscopy-guided access .", "in a clinical trial , @ patients who were candidate for pcnl , were randomly assigned into blind group ( @ ) and fluoroscopy-guided group ( @ ) .", "in group @ the lumbar notch was used to guide percutaneous access and in group @ fluoroscopy performed after needle insertion , amplatz placement and at the end of surgery .", "if the access failed , we would repeat puncturing up to @ times .", "in group @ , access was achieved using full fluoroscopy guidance .", "all patients underwent postoperative assessment including kidney-ureter-bladder x-ray and ultrasonography .", "both mean access time and mean operation time were statically similar in group @ and group @ ( @ @ vs. @ @ min and @ @ vs. @ @ min , respectively ) .", "a successful puncture was achieved in @ % and @ % of the patients in groups @ and @ , respectively ( p = @ ) .", "total success rate of procedure was @ % and @ % of the patients in groups @ and @ , respectively ( p = @ ) .", "according to this study , it seems that blind access is a safe and effective pcnl method , and we recommend employment of this technique by skilled endourologist in urology centers especially for patient with large hydronephrotic kidney ." ]
due to the negative impact of radiation on the patient and the surgical team during percutaneous nephrolithotomy ( pcnl ) , we aimed to evaluate success rate and complications of blind access for pcnl using lumbar notch landmark and compare with conventional fluoroscopy-guided access . in a clinical trial , @ patients who were candidate for pcnl , were randomly assigned into blind group ( @ ) and fluoroscopy-guided group ( @ ) . in group @ the lumbar notch was used to guide percutaneous access and in group @ fluoroscopy performed after needle insertion , amplatz placement and at the end of surgery . if the access failed , we would repeat puncturing up to @ times . in group @ , access was achieved using full fluoroscopy guidance . all patients underwent postoperative assessment including kidney-ureter-bladder x-ray and ultrasonography . both mean access time and mean operation time were statically similar in group @ and group @ ( @ @ vs. @ @ min and @ @ vs. @ @ min , respectively ) . a successful puncture was achieved in @ % and @ % of the patients in groups @ and @ , respectively ( p = @ ) . total success rate of procedure was @ % and @ % of the patients in groups @ and @ , respectively ( p = @ ) . according to this study , it seems that blind access is a safe and effective pcnl method , and we recommend employment of this technique by skilled endourologist in urology centers especially for patient with large hydronephrotic kidney .
24,807,748
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to evaluate the effectiveness of the computerized cbt ( ccbt ) programme , moodgym , for the reduction in symptoms of general psychological distress ( the primary outcome ) , depression , anxiety , stress , and impaired daily functioning .", "a randomized controlled trial , with a waiting list control condition , in a routine clinical setting .", "participants were @ public mental health service users ( aged @-@ -lsb- m = @ years ; sd = @ -rsb- ) waiting for interventions .", "self-report outcome measures were administered online at baseline and post-intervention ( i.e. , after @ days ) .", "after high dropout rates , a post-intervention completers analysis examined @ moodgym participants and @ waiting list control participants .", "moodgym was significantly more effective than the waiting list control for the reduction of symptoms of general psychological distress ( f -lsb- @ , @ -rsb- = @ ; p < @ ) and stress ( f -lsb- @ , @ -rsb- = @ ; p < @ ) but not depression , anxiety , or impaired daily functioning .", "due to their high associated dropout rates , self-help ccbt programmes such as moodgym should not be provided as front-line treatments .", "however , as it is likely to be agreeable and beneficial to some service users , perhaps self-help ccbt should be provided as an additional treatment option ." ]
to evaluate the effectiveness of the computerized cbt ( ccbt ) programme , moodgym , for the reduction in symptoms of general psychological distress ( the primary outcome ) , depression , anxiety , stress , and impaired daily functioning . a randomized controlled trial , with a waiting list control condition , in a routine clinical setting . participants were @ public mental health service users ( aged @-@ -lsb- m = @ years ; sd = @ -rsb- ) waiting for interventions . self-report outcome measures were administered online at baseline and post-intervention ( i.e. , after @ days ) . after high dropout rates , a post-intervention completers analysis examined @ moodgym participants and @ waiting list control participants . moodgym was significantly more effective than the waiting list control for the reduction of symptoms of general psychological distress ( f -lsb- @ , @ -rsb- = @ ; p < @ ) and stress ( f -lsb- @ , @ -rsb- = @ ; p < @ ) but not depression , anxiety , or impaired daily functioning . due to their high associated dropout rates , self-help ccbt programmes such as moodgym should not be provided as front-line treatments . however , as it is likely to be agreeable and beneficial to some service users , perhaps self-help ccbt should be provided as an additional treatment option .
24,831,119
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "single-centre series of the management of patients with ruptured abdominal aortic aneurysm ( aaa ) are usually too small to identify clinical factors that could improve patient outcomes .", "improve is a pragmatic , multicentre randomized clinical trial in which eligible patients with a clinical diagnosis of ruptured aneurysm were allocated to a strategy of endovascular aneurysm repair ( evar ) or to open repair .", "the influences of time and manner of hospital presentation , fluid volume status , type of anaesthesia , type of endovascular repair and time to aneurysm repair on @-day mortality were investigated according to a prespecified plan , for the subgroup of patients with a proven diagnosis of ruptured or symptomatic aaa .", "adjustment was made for potential confounding factors .", "some @ of @ randomized patients had a symptomatic or ruptured aneurysm : diagnostic accuracy was @ per cent .", "patients randomized outside routine working hours had higher operative mortality ( adjusted odds ratio ( or ) @ , @ per cent confidence interval @ to @ ) .", "mortality rates after primary and secondary presentation were similar .", "lowest systolic blood pressure was strongly and independently associated with @-day mortality ( @ per cent among those with pressure below @ mmhg ) .", "patients who received evar under local anaesthesia alone had greatly reduced @-day mortality compared with those who had general anaesthesia ( adjusted or @ , @ to @ ) .", "these findings suggest that the outcome of ruptured aaa might be improved by wider use of local anaesthesia for evar and that a minimum blood pressure of @ mmhg is too low a threshold for permissive hypotension ." ]
single-centre series of the management of patients with ruptured abdominal aortic aneurysm ( aaa ) are usually too small to identify clinical factors that could improve patient outcomes . improve is a pragmatic , multicentre randomized clinical trial in which eligible patients with a clinical diagnosis of ruptured aneurysm were allocated to a strategy of endovascular aneurysm repair ( evar ) or to open repair . the influences of time and manner of hospital presentation , fluid volume status , type of anaesthesia , type of endovascular repair and time to aneurysm repair on @-day mortality were investigated according to a prespecified plan , for the subgroup of patients with a proven diagnosis of ruptured or symptomatic aaa . adjustment was made for potential confounding factors . some @ of @ randomized patients had a symptomatic or ruptured aneurysm : diagnostic accuracy was @ per cent . patients randomized outside routine working hours had higher operative mortality ( adjusted odds ratio ( or ) @ , @ per cent confidence interval @ to @ ) . mortality rates after primary and secondary presentation were similar . lowest systolic blood pressure was strongly and independently associated with @-day mortality ( @ per cent among those with pressure below @ mmhg ) . patients who received evar under local anaesthesia alone had greatly reduced @-day mortality compared with those who had general anaesthesia ( adjusted or @ , @ to @ ) . these findings suggest that the outcome of ruptured aaa might be improved by wider use of local anaesthesia for evar and that a minimum blood pressure of @ mmhg is too low a threshold for permissive hypotension .
24,469,620
[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "conventional glucocorticoid replacement therapy fails to mimic the physiological cortisol rhythm , which may have implications for morbidity and mortality in patients with addison 's disease .", "the objective of the study was to compare the effects of continuous sc hydrocortisone infusion ( cshi ) with conventional oral hydrocortisone ( ohc ) replacement therapy .", "this was a prospective crossover , randomized , multicenter clinical trial comparing @ months of treatment with thrice-daily ohc vs cshi .", "from norway and sweden , @ patients were enrolled from registries and clinics .", "all patients were assessed at baseline and after @ and @ weeks in each treatment arm .", "the morning acth level was the primary outcome measure .", "secondary outcome measures were effects on metabolism , health-related quality of life ( hrqol ) , sleep , and safety .", "cshi yielded normalization of morning acth and cortisol levels , and @-hour salivary cortisol curves resembled the normal circadian variation .", "urinary concentrations of glucocorticoid metabolites displayed a normal pattern with cshi but were clearly altered with ohc .", "several hrqol indices in the vitality domain improved over time with cshi .", "no benefit was found for either treatments for any subjective ( pittsburgh sleep quality index questionnaire ) or objective ( actigraphy ) sleep parameters .", "cshi safely brought acth and cortisol toward normal circadian levels without adversely affecting glucocorticoid metabolism in the way that ohc did .", "positive effects on hrqol were noted with cshi , indicating that physiological glucocorticoid replacement therapy may be beneficial and that cshi might become a treatment option for patients poorly controlled on conventional therapy ." ]
conventional glucocorticoid replacement therapy fails to mimic the physiological cortisol rhythm , which may have implications for morbidity and mortality in patients with addison 's disease . the objective of the study was to compare the effects of continuous sc hydrocortisone infusion ( cshi ) with conventional oral hydrocortisone ( ohc ) replacement therapy . this was a prospective crossover , randomized , multicenter clinical trial comparing @ months of treatment with thrice-daily ohc vs cshi . from norway and sweden , @ patients were enrolled from registries and clinics . all patients were assessed at baseline and after @ and @ weeks in each treatment arm . the morning acth level was the primary outcome measure . secondary outcome measures were effects on metabolism , health-related quality of life ( hrqol ) , sleep , and safety . cshi yielded normalization of morning acth and cortisol levels , and @-hour salivary cortisol curves resembled the normal circadian variation . urinary concentrations of glucocorticoid metabolites displayed a normal pattern with cshi but were clearly altered with ohc . several hrqol indices in the vitality domain improved over time with cshi . no benefit was found for either treatments for any subjective ( pittsburgh sleep quality index questionnaire ) or objective ( actigraphy ) sleep parameters . cshi safely brought acth and cortisol toward normal circadian levels without adversely affecting glucocorticoid metabolism in the way that ohc did . positive effects on hrqol were noted with cshi , indicating that physiological glucocorticoid replacement therapy may be beneficial and that cshi might become a treatment option for patients poorly controlled on conventional therapy .
24,517,155
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "studies have suggested a link between diet and behavior in children with autism spectrum disorders ( asds ) .", "parental reports of behavioral changes upon exposure to gluten and/or casein are common in clinical practice .", "an association between diet type , intestinal permeability ( ip ) ( ` leaky gut ' ) , and behavior has been long proposed but not substantiated .", "we explored this possible association in this trial .", "this randomized double-blind , placebo-controlled study explored the effects of gluten and milk on ip and behavior in children with asds over a period of @ weeks .", "ip assessed by lactulose : mannitol ( l/m ) sugar permeability test and behavior assessed by the aberrant behavior checklist and conners parent rating were measured .", "gastrointestinal symptoms in both groups were also monitored .", "neither the l/m ratio nor behavioral scores were different between groups exposed to gluten/dairy or placebo .", "the changes observed were noted to be small and not clinically significant .", "our study although underpowered to show small differences does not support an association between dietary gluten/milk , ip , and behavioral changes in subjects with asd ." ]
studies have suggested a link between diet and behavior in children with autism spectrum disorders ( asds ) . parental reports of behavioral changes upon exposure to gluten and/or casein are common in clinical practice . an association between diet type , intestinal permeability ( ip ) ( ` leaky gut ' ) , and behavior has been long proposed but not substantiated . we explored this possible association in this trial . this randomized double-blind , placebo-controlled study explored the effects of gluten and milk on ip and behavior in children with asds over a period of @ weeks . ip assessed by lactulose : mannitol ( l/m ) sugar permeability test and behavior assessed by the aberrant behavior checklist and conners parent rating were measured . gastrointestinal symptoms in both groups were also monitored . neither the l/m ratio nor behavioral scores were different between groups exposed to gluten/dairy or placebo . the changes observed were noted to be small and not clinically significant . our study although underpowered to show small differences does not support an association between dietary gluten/milk , ip , and behavioral changes in subjects with asd .
24,564,346
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "optimization of systolic blood pressure and lipid levels are essential for secondary prevention after ischemic stroke , but there are substantial gaps in care , which could be addressed by nurse - or pharmacist-led care .", "we compared @ types of case management ( active prescribing by pharmacists or nurse-led screening and feedback to primary care physicians ) in addition to usual care .", "we performed a prospective randomized controlled trial involving adults with recent minor ischemic stroke or transient ischemic attack whose systolic blood pressure or lipid levels were above guideline targets .", "participants in both groups had a monthly visit for @ months with either a nurse or pharmacist .", "nurses measured cardiovascular risk factors , counselled patients and faxed results to primary care physicians ( active control ) .", "pharmacists did all of the above as well as prescribed according to treatment algorithms ( intervention ) .", "most of the @ study participants ( mean age @ yr , mean systolic blood pressure @ mm hg , mean low-density lipoprotein -lsb- ldl -rsb- cholesterol @ mmol/l ) were already receiving treatment at baseline ( antihypertensives : @ % ; statins : @ % ) , but none met guideline targets ( systolic blood pressure @ mm hg , fasting ldl cholesterol @ mmol/l ) .", "substantial improvements were observed in both groups after @ months : @ % of participants in the pharmacist case manager group met both systolic blood pressure and ldl guideline targets compared with @ % in the nurse-led group ( @ % absolute difference ; number needed to treat = @ , p = @ ) .", "compared with nurse-led case management ( risk factor evaluation , counselling and feedback to primary care providers ) , active case management by pharmacists substantially improved risk factor control at @ months among patients who had experienced a stroke .", "clinicaltrials.gov , no .", "nct@ ." ]
optimization of systolic blood pressure and lipid levels are essential for secondary prevention after ischemic stroke , but there are substantial gaps in care , which could be addressed by nurse - or pharmacist-led care . we compared @ types of case management ( active prescribing by pharmacists or nurse-led screening and feedback to primary care physicians ) in addition to usual care . we performed a prospective randomized controlled trial involving adults with recent minor ischemic stroke or transient ischemic attack whose systolic blood pressure or lipid levels were above guideline targets . participants in both groups had a monthly visit for @ months with either a nurse or pharmacist . nurses measured cardiovascular risk factors , counselled patients and faxed results to primary care physicians ( active control ) . pharmacists did all of the above as well as prescribed according to treatment algorithms ( intervention ) . most of the @ study participants ( mean age @ yr , mean systolic blood pressure @ mm hg , mean low-density lipoprotein -lsb- ldl -rsb- cholesterol @ mmol/l ) were already receiving treatment at baseline ( antihypertensives : @ % ; statins : @ % ) , but none met guideline targets ( systolic blood pressure @ mm hg , fasting ldl cholesterol @ mmol/l ) . substantial improvements were observed in both groups after @ months : @ % of participants in the pharmacist case manager group met both systolic blood pressure and ldl guideline targets compared with @ % in the nurse-led group ( @ % absolute difference ; number needed to treat = @ , p = @ ) . compared with nurse-led case management ( risk factor evaluation , counselling and feedback to primary care providers ) , active case management by pharmacists substantially improved risk factor control at @ months among patients who had experienced a stroke . clinicaltrials.gov , no . nct@ .
24,733,770
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND" ]
[ "the antibiotic rifaximin is used to treat non-constipated irritable bowel syndrome ( ibs ) .", "methane production is associated with constipation and its severity in constipation-predominant ibs ( c-ibs ) .", "a previous retrospective study suggested that rifaximin and neomycin was superior to neomycin alone in improving symptoms in methane-positive subjects .", "to determine the effectiveness of neomycin alone or with rifaximin in improving symptoms in methane-positive c-ibs subjects .", "a double-blind , randomized , placebo-controlled trial was performed from @ to @ at three tertiary care centers .", "subjects aged @-@ with c-ibs ( rome ii criteria ) and breath methane ( > @ppm ) meeting the inclusion and exclusion criteria were recruited .", "subjects completed a baseline symptom questionnaire rating the severity of abdominal and bowel symptoms on a visual analog scale and were randomized to receive neomycin and placebo or neomycin and rifaximin for @ days .", "symptom severity was assessed by weekly questionnaire for @weeks of therapy and @ additional weeks of follow-up .", "thirty-one subjects ( @ neomycin and placebo , @ neomycin and rifaximin ) were included in the intention-to-treat analysis .", "constipation severity was significantly lower in the neomycin and rifaximin group ( @ ) compared to neomycin alone ( @ ) ( p = @ ) , with greater improvement in constipation ( p = @ ) , straining ( p = @ ) and bloating ( p = @ ) , but not abdominal pain .", "in the neomycin and rifaximin group , subjects with methane < @ppm after treatment reported significantly lower constipation severity ( @ ) than subjects with persistent methane ( @ ) ( p = @ ) .", "rifaximin plus neomycin is superior to neomycin alone in improving multiple c-ibs symptoms .", "this effect is predicted by a reduction in breath methane ." ]
the antibiotic rifaximin is used to treat non-constipated irritable bowel syndrome ( ibs ) . methane production is associated with constipation and its severity in constipation-predominant ibs ( c-ibs ) . a previous retrospective study suggested that rifaximin and neomycin was superior to neomycin alone in improving symptoms in methane-positive subjects . to determine the effectiveness of neomycin alone or with rifaximin in improving symptoms in methane-positive c-ibs subjects . a double-blind , randomized , placebo-controlled trial was performed from @ to @ at three tertiary care centers . subjects aged @-@ with c-ibs ( rome ii criteria ) and breath methane ( > @ppm ) meeting the inclusion and exclusion criteria were recruited . subjects completed a baseline symptom questionnaire rating the severity of abdominal and bowel symptoms on a visual analog scale and were randomized to receive neomycin and placebo or neomycin and rifaximin for @ days . symptom severity was assessed by weekly questionnaire for @weeks of therapy and @ additional weeks of follow-up . thirty-one subjects ( @ neomycin and placebo , @ neomycin and rifaximin ) were included in the intention-to-treat analysis . constipation severity was significantly lower in the neomycin and rifaximin group ( @ ) compared to neomycin alone ( @ ) ( p = @ ) , with greater improvement in constipation ( p = @ ) , straining ( p = @ ) and bloating ( p = @ ) , but not abdominal pain . in the neomycin and rifaximin group , subjects with methane < @ppm after treatment reported significantly lower constipation severity ( @ ) than subjects with persistent methane ( @ ) ( p = @ ) . rifaximin plus neomycin is superior to neomycin alone in improving multiple c-ibs symptoms . this effect is predicted by a reduction in breath methane .
24,788,320
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "stellate ganglion block ( sgb ) is effective for treatment of bell 's palsy in patients with diabetes mellitus .", "corticosteroids are widely used for treatment of bell 's palsy in patients with diabetes mellitus but may induce complications like hyperglycemia , which calls for an alternative therapy .", "this study aimed to ascertain the effect of sgb on bell 's palsy in patients with diabetes mellitus .", "this randomized and single-blinded clinical trial involved @ diabetic patients with bell 's palsy that were randomly divided into a control group ( n = @ ) and a treatment group ( sgb group , n = @ ) .", "the house-brackmann scale and facial disability index ( fdi , including fdip and fdis ) were observed before treatment and at @ and @ months after treatment for assessment of the outcome .", "no statistically significant difference was found between the two groups before treatment as regards the house-brackmann scale and fdi .", "there was a statistically significant difference in fdip score in the two groups after treatment in comparison with before treatment .", "the fdis score showed a statistical difference between the two groups after treatment ." ]
stellate ganglion block ( sgb ) is effective for treatment of bell 's palsy in patients with diabetes mellitus . corticosteroids are widely used for treatment of bell 's palsy in patients with diabetes mellitus but may induce complications like hyperglycemia , which calls for an alternative therapy . this study aimed to ascertain the effect of sgb on bell 's palsy in patients with diabetes mellitus . this randomized and single-blinded clinical trial involved @ diabetic patients with bell 's palsy that were randomly divided into a control group ( n = @ ) and a treatment group ( sgb group , n = @ ) . the house-brackmann scale and facial disability index ( fdi , including fdip and fdis ) were observed before treatment and at @ and @ months after treatment for assessment of the outcome . no statistically significant difference was found between the two groups before treatment as regards the house-brackmann scale and fdi . there was a statistically significant difference in fdip score in the two groups after treatment in comparison with before treatment . the fdis score showed a statistical difference between the two groups after treatment .
24,547,956
[ "CONCLUSIONS", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS" ]
[ "glucose fluctuation often remains to be corrected under basal-supported oral therapy .", "we investigated the efficacy of adding once-daily rapid-acting insulin in japanese diabetes patients treated with basal-supported oral therapy .", "in this @-week , parallel-group , randomized , open-label trial , @ japanese adults with type @ diabetes treated with insulin glargine and @ mg of sitagliptin were randomized into the following two arms : the single-bolus group , in which once-daily insulin glulisine was initiated at a main meal at a fifth ( i.e. , @ % ) the dose of insulin glargine , and the control group , in which the dose of sitagliptin was maximized to @ mg .", "the primary end point was the change of glycemic fluctuation assessed with the m-value .", "baseline hemoglobin a@c levels , mean blood glucose profiles , and m-value were @ @ % , @ @ mmol/l , and @ @ units , respectively .", "at the end of the study , the single-bolus group had a greater reduction of m-value than the control group ( p = @ ) ; the difference was @ units ( @ % confidence interval , @-@ @ units ) .", "the single-bolus group also had a greater reduction of mean blood glucose levels ( p = @ ) .", "there were no significant differences in the incidence of hypoglycemia or the weight change between the two groups ( p > @ ) .", "adding once-daily insulin glulisine was more effective in controlling the glycemic fluctuation in japanese type @ diabetes patients treated with insulin glargine together with sitagliptin ." ]
glucose fluctuation often remains to be corrected under basal-supported oral therapy . we investigated the efficacy of adding once-daily rapid-acting insulin in japanese diabetes patients treated with basal-supported oral therapy . in this @-week , parallel-group , randomized , open-label trial , @ japanese adults with type @ diabetes treated with insulin glargine and @ mg of sitagliptin were randomized into the following two arms : the single-bolus group , in which once-daily insulin glulisine was initiated at a main meal at a fifth ( i.e. , @ % ) the dose of insulin glargine , and the control group , in which the dose of sitagliptin was maximized to @ mg . the primary end point was the change of glycemic fluctuation assessed with the m-value . baseline hemoglobin a@c levels , mean blood glucose profiles , and m-value were @ @ % , @ @ mmol/l , and @ @ units , respectively . at the end of the study , the single-bolus group had a greater reduction of m-value than the control group ( p = @ ) ; the difference was @ units ( @ % confidence interval , @-@ @ units ) . the single-bolus group also had a greater reduction of mean blood glucose levels ( p = @ ) . there were no significant differences in the incidence of hypoglycemia or the weight change between the two groups ( p > @ ) . adding once-daily insulin glulisine was more effective in controlling the glycemic fluctuation in japanese type @ diabetes patients treated with insulin glargine together with sitagliptin .
24,949,654
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "although d@ lymphadenectomy has been shown to improve outcomes in gastric cancer , it may increase postoperative morbidity , mainly owing to splenopancreatic complications .", "in addition , the effects of nodal dissection along the proper hepatic artery have not been extensively elucidated .", "we hypothesized that modified d@ ( ie , d@ + ) lymphadenectomy may decrease surgical risks without impairing oncologic adequacy .", "patients with node-positive gastric cancer undergoing curative total gastrectomy were intraoperatively randomized to d@ + ( group @ , @ patients ) or standard d@ lymphadenectomy ( group @ , @ patients ) , the latter including splenectomy and nodal group @a .", "the index of estimated benefit was used to assess the efficacy of dissection of each nodal station .", "the primary endpoint for oncologic adequacy was the disease-free survival ( dfs ) rate .", "surgical complications were significantly more common in group @ , which also included @ postoperative deaths .", "overall , @ patients ( @ % ) experienced tumor recurrence .", "the primary site of tumor relapse and the @-year dfs rate were not different between the @ groups .", "involvement of the second nodal level was associated with a worse dfs rate ; however , patients undergoing more extensive lymphadenectomy did not show a better dfs rate .", "the incidence of involvement of nodal stations @ , @d , and @a was @ % , and the @-year dfs rate was zero .", "consequently , the benefit to dissect such lymph nodes was null .", "these findings suggest that modified d@ lymphadenectomy confers the same oncologic adequacy as standard d@ lymphadenectomy , with a significant reduction of postoperative morbidity ." ]
although d@ lymphadenectomy has been shown to improve outcomes in gastric cancer , it may increase postoperative morbidity , mainly owing to splenopancreatic complications . in addition , the effects of nodal dissection along the proper hepatic artery have not been extensively elucidated . we hypothesized that modified d@ ( ie , d@ + ) lymphadenectomy may decrease surgical risks without impairing oncologic adequacy . patients with node-positive gastric cancer undergoing curative total gastrectomy were intraoperatively randomized to d@ + ( group @ , @ patients ) or standard d@ lymphadenectomy ( group @ , @ patients ) , the latter including splenectomy and nodal group @a . the index of estimated benefit was used to assess the efficacy of dissection of each nodal station . the primary endpoint for oncologic adequacy was the disease-free survival ( dfs ) rate . surgical complications were significantly more common in group @ , which also included @ postoperative deaths . overall , @ patients ( @ % ) experienced tumor recurrence . the primary site of tumor relapse and the @-year dfs rate were not different between the @ groups . involvement of the second nodal level was associated with a worse dfs rate ; however , patients undergoing more extensive lymphadenectomy did not show a better dfs rate . the incidence of involvement of nodal stations @ , @d , and @a was @ % , and the @-year dfs rate was zero . consequently , the benefit to dissect such lymph nodes was null . these findings suggest that modified d@ lymphadenectomy confers the same oncologic adequacy as standard d@ lymphadenectomy , with a significant reduction of postoperative morbidity .
25,532,433
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to demonstrate the safety and effectiveness of responsive stimulation at the seizure focus as an adjunctive therapy to reduce the frequency of seizures in adults with medically intractable partial onset seizures arising from one or two seizure foci .", "randomized multicenter double-blinded controlled trial of responsive focal cortical stimulation ( rns system ) .", "subjects with medically intractable partial onset seizures from one or two foci were implanted , and @month postimplant were randomized @:@ to active or sham stimulation .", "after the fifth postimplant month , all subjects received responsive stimulation in an open label period ( olp ) to complete @years of postimplant follow-up .", "all @ subjects were randomized .", "the percent change in seizures at the end of the blinded period was -@ % in the active and -@ % in the sham stimulation group ( p = @ , generalized estimating equations ) .", "the median percent reduction in seizures in the olp was @ % at @year and @ % at @years , which represents a progressive and significant improvement with time ( p < @ ) .", "the serious adverse event rate was not different between subjects receiving active and sham stimulation .", "adverse events were consistent with the known risks of an implanted medical device , seizures , and of other epilepsy treatments .", "there were no adverse effects on neuropsychological function or mood .", "responsive stimulation to the seizure focus reduced the frequency of partial-onset seizures acutely , showed improving seizure reduction over time , was well tolerated , and was acceptably safe .", "the rns system provides an additional treatment option for patients with medically intractable partial-onset seizures ." ]
to demonstrate the safety and effectiveness of responsive stimulation at the seizure focus as an adjunctive therapy to reduce the frequency of seizures in adults with medically intractable partial onset seizures arising from one or two seizure foci . randomized multicenter double-blinded controlled trial of responsive focal cortical stimulation ( rns system ) . subjects with medically intractable partial onset seizures from one or two foci were implanted , and @month postimplant were randomized @:@ to active or sham stimulation . after the fifth postimplant month , all subjects received responsive stimulation in an open label period ( olp ) to complete @years of postimplant follow-up . all @ subjects were randomized . the percent change in seizures at the end of the blinded period was -@ % in the active and -@ % in the sham stimulation group ( p = @ , generalized estimating equations ) . the median percent reduction in seizures in the olp was @ % at @year and @ % at @years , which represents a progressive and significant improvement with time ( p < @ ) . the serious adverse event rate was not different between subjects receiving active and sham stimulation . adverse events were consistent with the known risks of an implanted medical device , seizures , and of other epilepsy treatments . there were no adverse effects on neuropsychological function or mood . responsive stimulation to the seizure focus reduced the frequency of partial-onset seizures acutely , showed improving seizure reduction over time , was well tolerated , and was acceptably safe . the rns system provides an additional treatment option for patients with medically intractable partial-onset seizures .
24,621,228
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "cognitive impairment develops with pre-diabetes and dementia is a complication of diabetes .", "natural products like turmeric and cinnamon may ameliorate the underlying pathogenesis .", "people @ years ( n = @ ) with newly-recognised untreated pre-diabetes were randomised to a double-blind metabolic study of placebo , turmeric ( @ g ) , cinnamon ( @ g ) or both ( @ g & @ g respectively ) , ingested at a white bread ( @ g ) breakfast .", "observations were made over @ hours for pre - and post-working memory ( wm ) , glycaemic and insulin responses and biomarkers of alzheimer 's disease ( ad ) ( @ , @ , @ and @ hours ) : amyloid precursor protein ( app ) , - secretase subunits presenilin-@ ( ps@ ) , presenilin-@ ( ps@ ) , and glycogen synthase kinase ( gsk-@ ) .", "differences between natural product users and non-users were determined by students t and chi square tests ; and between pre-test and post-test wm by wilcoxon signed rank tests .", "interaction between turmeric and cinnamon was tested by @-way anova .", "multivariable linear regression ( mlr ) took account of bmi , glycaemia , insulin and ad biomarkers in the wm responses to turmeric and cinnamon .", "no interaction between turmeric and cinnamon was detected .", "wm increased from @ to @ out of @ ( p = @ ) with turmeric , but was unchanged with cinnamon .", "wm improvement was inversely associated with insulin resistance ( r = -@ , p < @ ) , but not with ad biomarkers .", "with mlr , the wm responses to turmeric were best predicted with an r@ of @ % ; and with significant turmeric , bmi and insulin/glucose auc beta-coefficients .", "co-ingestion of turmeric with white bread increases working memory independent of body fatness , glycaemia , insulin , or ad biomarkers ." ]
cognitive impairment develops with pre-diabetes and dementia is a complication of diabetes . natural products like turmeric and cinnamon may ameliorate the underlying pathogenesis . people @ years ( n = @ ) with newly-recognised untreated pre-diabetes were randomised to a double-blind metabolic study of placebo , turmeric ( @ g ) , cinnamon ( @ g ) or both ( @ g & @ g respectively ) , ingested at a white bread ( @ g ) breakfast . observations were made over @ hours for pre - and post-working memory ( wm ) , glycaemic and insulin responses and biomarkers of alzheimer 's disease ( ad ) ( @ , @ , @ and @ hours ) : amyloid precursor protein ( app ) , - secretase subunits presenilin-@ ( ps@ ) , presenilin-@ ( ps@ ) , and glycogen synthase kinase ( gsk-@ ) . differences between natural product users and non-users were determined by students t and chi square tests ; and between pre-test and post-test wm by wilcoxon signed rank tests . interaction between turmeric and cinnamon was tested by @-way anova . multivariable linear regression ( mlr ) took account of bmi , glycaemia , insulin and ad biomarkers in the wm responses to turmeric and cinnamon . no interaction between turmeric and cinnamon was detected . wm increased from @ to @ out of @ ( p = @ ) with turmeric , but was unchanged with cinnamon . wm improvement was inversely associated with insulin resistance ( r = -@ , p < @ ) , but not with ad biomarkers . with mlr , the wm responses to turmeric were best predicted with an r@ of @ % ; and with significant turmeric , bmi and insulin/glucose auc beta-coefficients . co-ingestion of turmeric with white bread increases working memory independent of body fatness , glycaemia , insulin , or ad biomarkers .
25,516,316
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to compare the bowel cleansing efficacy of same day ingestion of @-l sulfa-free polyethylene glycol ( @-l sf-peg ) vs @-l polyethylene glycol solution with ascorbic acid ( @-l peg + asc ) in patients undergoing afternoon colonoscopy .", "@ patients ( mean age @ years , @ % male ) undergoing outpatient screening or surveillance colonoscopies were prospectively randomized to receive either @-l sf-peg ( n = @ ) or @-l peg + asc solution ( n = @ ) .", "colonoscopies were performed by two blinded endoscopists .", "bowel preparation was graded using the ottawa scale .", "each participant completed a satisfaction and side effect survey .", "there was no difference in patient demographics amongst groups .", "@-l sf-peg resulted in better ottawa scores compared to @-l peg + asc , @ vs @ ( p = @ ) ; left colon : @ vs @ respectively ( p = @ ) , right colon : @ vs @ respectively ( p = @ ) .", "no difference in ottawa scores was found for the mid colon or amount of fluid .", "patient satisfaction was similar for both arms but those assigned to @-l sf-peg reported less bloating : @ % vs @ % ( p = @ ) .", "overall polyp detection , adenomatous polyp and advanced adenoma detection rates were similar between the two groups .", "morning only @-l sf-peg provided superior cleansing with less bloating as compared to @-l peg + asc bowel preparation for afternoon colonoscopy .", "thus , future studies evaluating efficacy of morning only preparation for afternoon colonoscopy should use @-l sf-peg as the standard comparator ." ]
to compare the bowel cleansing efficacy of same day ingestion of @-l sulfa-free polyethylene glycol ( @-l sf-peg ) vs @-l polyethylene glycol solution with ascorbic acid ( @-l peg + asc ) in patients undergoing afternoon colonoscopy . @ patients ( mean age @ years , @ % male ) undergoing outpatient screening or surveillance colonoscopies were prospectively randomized to receive either @-l sf-peg ( n = @ ) or @-l peg + asc solution ( n = @ ) . colonoscopies were performed by two blinded endoscopists . bowel preparation was graded using the ottawa scale . each participant completed a satisfaction and side effect survey . there was no difference in patient demographics amongst groups . @-l sf-peg resulted in better ottawa scores compared to @-l peg + asc , @ vs @ ( p = @ ) ; left colon : @ vs @ respectively ( p = @ ) , right colon : @ vs @ respectively ( p = @ ) . no difference in ottawa scores was found for the mid colon or amount of fluid . patient satisfaction was similar for both arms but those assigned to @-l sf-peg reported less bloating : @ % vs @ % ( p = @ ) . overall polyp detection , adenomatous polyp and advanced adenoma detection rates were similar between the two groups . morning only @-l sf-peg provided superior cleansing with less bloating as compared to @-l peg + asc bowel preparation for afternoon colonoscopy . thus , future studies evaluating efficacy of morning only preparation for afternoon colonoscopy should use @-l sf-peg as the standard comparator .
25,132,784
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "type b influenza virus is a major epidemic strain responsible for considerable mortality and morbidity .", "a colloidal gold immunochromatographic strip for the rapid detection of human influenza b virus was developed .", "this test is based on membrane chromatography and uses colloidal gold conjugated with influenza b virus anti-np monoclonal antibody as the tracer .", "the assembled test strip was housed in a plastic case .", "the colloid gold strip ( cgs ) specifically detected all influenza b viruses tested and did not react with other respiratory viruses .", "compared with sybr green real-time pcr , the sensitivity and specificity of the cgs test was @ % and @ % , respectively , and the consistency ratio between cgs and real-time pcr was @ % in detecting influenza b virus in @ nasopharyngeal swabs from patients with influenza-like illness in the hospital .", "the cgs array developed in this study enabled typing of influenza b viruses in human clinical specimens .", "thus , together with the advantages of rapid detection and easy operation without requiring specialized personnel and equipment , this technique is a convenient and relatively inexpensive diagnostic tool for large-scale screening of clinical samples ." ]
type b influenza virus is a major epidemic strain responsible for considerable mortality and morbidity . a colloidal gold immunochromatographic strip for the rapid detection of human influenza b virus was developed . this test is based on membrane chromatography and uses colloidal gold conjugated with influenza b virus anti-np monoclonal antibody as the tracer . the assembled test strip was housed in a plastic case . the colloid gold strip ( cgs ) specifically detected all influenza b viruses tested and did not react with other respiratory viruses . compared with sybr green real-time pcr , the sensitivity and specificity of the cgs test was @ % and @ % , respectively , and the consistency ratio between cgs and real-time pcr was @ % in detecting influenza b virus in @ nasopharyngeal swabs from patients with influenza-like illness in the hospital . the cgs array developed in this study enabled typing of influenza b viruses in human clinical specimens . thus , together with the advantages of rapid detection and easy operation without requiring specialized personnel and equipment , this technique is a convenient and relatively inexpensive diagnostic tool for large-scale screening of clinical samples .
24,839,825
[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "minimally invasive techniques commonly are applied to mitral valve surgery ; however , there has been little research investigating the optimal methods of cardiopulmonary bypass for the right minithoracotomy approach .", "controversy exists as to whether a percutaneous superior vena cava drainage cannula ( psvc ) is necessary during these operations .", "the authors , therefore , sought to determine the effect of using a percutaneous superior vena cava catheter on brain near-infrared spectroscopy , blood lactate levels , hemodynamics and surgical parameters .", "randomized , blinded , crossover trial .", "tertiary care university hospital .", "patients undergoing minimally invasive mitral valve surgery via a right minithoracotomy .", "twenty minutes of either clamped or unclamped percutaneous superior vena cava neck catheter drainage , during mitral valve repair .", "for the primary outcome of brain near-infrared spectroscopy , there were no differences between the two groups ( percutaneous superior vena cava clamped @ % @ % versus unclamped @ % @ % ) ( p = @ ) .", "for the secondary outcomes ph ( clamped @ versus unclamped @ p = @ ) , surgical score ( clamped @ versus unclamped @ p = @ ) and cvp ( clamped @ mmhg@ @ mmhg versus unclamped @ mmhg@ @ mmhg p < @ ) were significantly different .", "the use of a percutaneous superior vena cava drainage improved surgical visualization and lowered cvp , but had no effect on brain near infrared spectroscopy during minimally invasive mitral valve surgery .", "( clinicaltrials.gov identifier : nct@ ) ." ]
minimally invasive techniques commonly are applied to mitral valve surgery ; however , there has been little research investigating the optimal methods of cardiopulmonary bypass for the right minithoracotomy approach . controversy exists as to whether a percutaneous superior vena cava drainage cannula ( psvc ) is necessary during these operations . the authors , therefore , sought to determine the effect of using a percutaneous superior vena cava catheter on brain near-infrared spectroscopy , blood lactate levels , hemodynamics and surgical parameters . randomized , blinded , crossover trial . tertiary care university hospital . patients undergoing minimally invasive mitral valve surgery via a right minithoracotomy . twenty minutes of either clamped or unclamped percutaneous superior vena cava neck catheter drainage , during mitral valve repair . for the primary outcome of brain near-infrared spectroscopy , there were no differences between the two groups ( percutaneous superior vena cava clamped @ % @ % versus unclamped @ % @ % ) ( p = @ ) . for the secondary outcomes ph ( clamped @ versus unclamped @ p = @ ) , surgical score ( clamped @ versus unclamped @ p = @ ) and cvp ( clamped @ mmhg@ @ mmhg versus unclamped @ mmhg@ @ mmhg p < @ ) were significantly different . the use of a percutaneous superior vena cava drainage improved surgical visualization and lowered cvp , but had no effect on brain near infrared spectroscopy during minimally invasive mitral valve surgery . ( clinicaltrials.gov identifier : nct@ ) .
25,440,652
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "a new gel formulation containing loteprednol etabonate ( le ) , a c-@ ester corticosteroid used to treat ocular inflammation , was developed to provide increased retention on the ocular surface for improved drug delivery to intraocular tissues .", "this investigation evaluated concentrations of le in tear fluid following topical instillation of le gel to humans and the ocular and systemic pharmacokinetics of le following administration to rabbits .", "le ophthalmic gel @ % was administered as a single topical dose to human volunteers ( n = @ ) and dutch belted rabbits ( n = @ ) .", "in the human study , tear sampling was performed at @ , @ , @ , and @h after instillation .", "in the rabbit study , tears and ocular tissues were collected from @min through @h postdose .", "serial blood samples were collected from one cohort of rabbits for plasma analysis .", "concentrations of le were determined by high performance liquid chromatography tandem mass spectrometry .", "in humans , le was detected in tears at all the time points assessed with mean concentrations of @g/g at @h declining to @ g/g at @h postdose .", "in rabbits , le was detected in all ocular tissues within @min after dosing .", "maximum concentrations of le were achieved within @ h and were highest in tear fluid ( @g/g ) , followed by bulbar conjunctiva ( @ g/g ) , cornea , ( @ g/g ) , iris/ciliary body ( @ g/g ) , and aqueous humor ( @ g/ml ) .", "le remained measurable in all ocular tissues through @h with the exception of aqueous humor .", "in contrast , plasma levels of le were low with no detectable levels after @h .", "the gel formulation of le provided prolonged exposure to le on the ocular surface , with measurable levels in tears through @h in both humans and rabbits , for delivery of le to anterior segment tissues , as evidenced by sustained levels of le in rabbit conjunctiva , cornea , and iris/ciliary body ." ]
a new gel formulation containing loteprednol etabonate ( le ) , a c-@ ester corticosteroid used to treat ocular inflammation , was developed to provide increased retention on the ocular surface for improved drug delivery to intraocular tissues . this investigation evaluated concentrations of le in tear fluid following topical instillation of le gel to humans and the ocular and systemic pharmacokinetics of le following administration to rabbits . le ophthalmic gel @ % was administered as a single topical dose to human volunteers ( n = @ ) and dutch belted rabbits ( n = @ ) . in the human study , tear sampling was performed at @ , @ , @ , and @h after instillation . in the rabbit study , tears and ocular tissues were collected from @min through @h postdose . serial blood samples were collected from one cohort of rabbits for plasma analysis . concentrations of le were determined by high performance liquid chromatography tandem mass spectrometry . in humans , le was detected in tears at all the time points assessed with mean concentrations of @g/g at @h declining to @ g/g at @h postdose . in rabbits , le was detected in all ocular tissues within @min after dosing . maximum concentrations of le were achieved within @ h and were highest in tear fluid ( @g/g ) , followed by bulbar conjunctiva ( @ g/g ) , cornea , ( @ g/g ) , iris/ciliary body ( @ g/g ) , and aqueous humor ( @ g/ml ) . le remained measurable in all ocular tissues through @h with the exception of aqueous humor . in contrast , plasma levels of le were low with no detectable levels after @h . the gel formulation of le provided prolonged exposure to le on the ocular surface , with measurable levels in tears through @h in both humans and rabbits , for delivery of le to anterior segment tissues , as evidenced by sustained levels of le in rabbit conjunctiva , cornea , and iris/ciliary body .
24,325,539
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "long acting reversible contraception ( larc ) methods are highly effective in reducing the incidence of unwanted pregnancy .", "recent data indicates that the rate of abortion in grampian , north east of scotland is above the scottish average and larc uptake among young women low .", "this study sought to explore young women 's perceptions of larc , with the aim of developing a strategy to increase larc uptake .", "qualitative study .", "sixty five women aged @-@ were randomly recruited to this qualitative study from community centres and shopping areas .", "recruitment and interviews were conducted in friendship pairs , triads or one-to-one basis .", "participants were asked about current and past contraception use , views of contraception methods including larc ; and sources of information about contraception .", "data were analysed using thematic content analysis .", "women interviewed were aware of some of the delivery systems used for long acting contraception ( intrauterine devices , implants and injections ) but did not recognise them as ` larc ' .", "` long acting ' was equated with permanency and the term ` reversible ' appeared to have the opposite effect to its intention .", "intrauterine devices were commonly referred to as ` coil ' .", "the women often relied on verbal testimonies from those who had experienced using larc , many of which were negative and inaccurate .", "a lack of in-depth knowledge about larc and the opinion that larc methods were for older women were also cited as barriers to use .", "this study shows that negative testimonies and the belief that larc are not appropriate for young women may discourage larc uptake ." ]
long acting reversible contraception ( larc ) methods are highly effective in reducing the incidence of unwanted pregnancy . recent data indicates that the rate of abortion in grampian , north east of scotland is above the scottish average and larc uptake among young women low . this study sought to explore young women 's perceptions of larc , with the aim of developing a strategy to increase larc uptake . qualitative study . sixty five women aged @-@ were randomly recruited to this qualitative study from community centres and shopping areas . recruitment and interviews were conducted in friendship pairs , triads or one-to-one basis . participants were asked about current and past contraception use , views of contraception methods including larc ; and sources of information about contraception . data were analysed using thematic content analysis . women interviewed were aware of some of the delivery systems used for long acting contraception ( intrauterine devices , implants and injections ) but did not recognise them as ` larc ' . ` long acting ' was equated with permanency and the term ` reversible ' appeared to have the opposite effect to its intention . intrauterine devices were commonly referred to as ` coil ' . the women often relied on verbal testimonies from those who had experienced using larc , many of which were negative and inaccurate . a lack of in-depth knowledge about larc and the opinion that larc methods were for older women were also cited as barriers to use . this study shows that negative testimonies and the belief that larc are not appropriate for young women may discourage larc uptake .
25,369,357
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "epidural injections are performed to manage lumbar central spinal stenosis pain utilizing caudal , interlaminar , and transforaminal approaches .", "the literature on the efficacy of epidural injections in managing lumbar central spinal stenosis pain is sparse ; lacking multiple , high quality randomized trials with long-term follow-up .", "two randomized controlled trials of the caudal and lumbar interlaminar approaches that assessed @ patients with lumbar central spinal stenosis were analyzed .", "the analysis found efficacy for both caudal and interlaminar approaches in managing chronic pain and disability from central spinal stenosis was demonstrated .", "in the patients responsive to treatment , those with at least @ weeks of improvement with the first @ procedures , @ % reported significant improvement with caudal epidural injections , whereas it was @ % with local anesthetic only with interlaminar epidurals , @ % with caudal and @ % with lumbar interlaminar with local anesthetic with steroid .", "the response rate was @ % with caudal and @ % with lumbar interlaminar with local anesthetic only and @ % with caudal and @ % with lumbar interlaminar with local anesthetic with steroid when all patients were considered .", "in the interlaminar approach , results were superior for pain relief and functional status with fewer nonresponsive patients compared to the caudal approach .", "the data was derived from @ previously published randomized , controlled trials rather than comparing @ techniques in one randomized controlled trial .", "further , the randomized controlled trials were active control trials without a placebo .", "the results of this assessment showed significant improvement in patients suffering with chronic lumbar spinal stenosis with caudal and interlaminar epidural approaches with local anesthetic only , or with steroids in a long-term follow-up of up to @ years , in contemporary interventional pain management setting , with the interlaminar approach providing significantly better results ." ]
epidural injections are performed to manage lumbar central spinal stenosis pain utilizing caudal , interlaminar , and transforaminal approaches . the literature on the efficacy of epidural injections in managing lumbar central spinal stenosis pain is sparse ; lacking multiple , high quality randomized trials with long-term follow-up . two randomized controlled trials of the caudal and lumbar interlaminar approaches that assessed @ patients with lumbar central spinal stenosis were analyzed . the analysis found efficacy for both caudal and interlaminar approaches in managing chronic pain and disability from central spinal stenosis was demonstrated . in the patients responsive to treatment , those with at least @ weeks of improvement with the first @ procedures , @ % reported significant improvement with caudal epidural injections , whereas it was @ % with local anesthetic only with interlaminar epidurals , @ % with caudal and @ % with lumbar interlaminar with local anesthetic with steroid . the response rate was @ % with caudal and @ % with lumbar interlaminar with local anesthetic only and @ % with caudal and @ % with lumbar interlaminar with local anesthetic with steroid when all patients were considered . in the interlaminar approach , results were superior for pain relief and functional status with fewer nonresponsive patients compared to the caudal approach . the data was derived from @ previously published randomized , controlled trials rather than comparing @ techniques in one randomized controlled trial . further , the randomized controlled trials were active control trials without a placebo . the results of this assessment showed significant improvement in patients suffering with chronic lumbar spinal stenosis with caudal and interlaminar epidural approaches with local anesthetic only , or with steroids in a long-term follow-up of up to @ years , in contemporary interventional pain management setting , with the interlaminar approach providing significantly better results .
25,415,784
[ "BACKGROUND", "BACKGROUND", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "scope of practice in audiology encompasses proficiency in visual inspection of ear canal and tympanic membrane ( tm ) as well as otoscopy interpretation skills to determine normal versus abnormal conditions of outer and middle ear .", "audiology students can develop skills in otoscopy through education and supervised training .", "studies have shown that additional otoscopy training increased skills in medical students and general practitioners .", "however , educational and supervised practices targeting otoscopy competency during audiology graduate coursework are lacking .", "also , no studies have attempted to determine otoscopy skills among audiology students .", "to determine the effectiveness of the otoscopy training model on clinical competency and confidence level of audiology students in performing and interpreting otoscopy .", "a combination of experimental treatment design with random assignment of treatment and control groups and delayed treatment for control group .", "thirty-two first - and second-year audiology graduate students who were enrolled in a pediatric audiology class participated in this study .", "students were randomly assigned to the control ( n = @ , @ females ) or experimental ( n = @ , @ females ) group .", "participants in the experimental group received supplementary otoscopy training including didactic otoscopy lectures as well as clinical training using manikin ears .", "the control group received the same pretest and posttest and then completed a third assessment ( posttest @ ) after receiving the same training .", "an evaluation of knowledge and skills regarding otoscopy between groups and time was conducted at three times : ( a ) pretraining , ( b ) upon completion of training for the experimental group , ( c ) upon completion of training by the control group .", "the evaluation consisted of a written exam , a clinical exam , and a self-perception rating of confidence .", "both written exam scores and clinical exam scores ( otoscopy manikin ) were analyzed via two-way analyses of variance ( anovas ) , whereas chi-square ( ) statistic was conducted to evaluate the effects of training on the confidence level of students of both groups .", "experimental and control groups demonstrated significant increased overall competency in otoscopy following the otoscopy training model with didactic and laboratory components .", "posttest confidence ratings showed increases in all groups , and there were no significant differences between groups .", "the need for supplementary otoscopy training was warranted by low knowledge and clinical competency in otoscopy skills of audiology students as measured by pretest mean scores .", "after completing the training , both experimental and control groups showed significant improvement in knowledge and competency .", "results also suggest that perceived confidence ratings may be misleading in determining students ' clinical otoscopy skills ." ]
scope of practice in audiology encompasses proficiency in visual inspection of ear canal and tympanic membrane ( tm ) as well as otoscopy interpretation skills to determine normal versus abnormal conditions of outer and middle ear . audiology students can develop skills in otoscopy through education and supervised training . studies have shown that additional otoscopy training increased skills in medical students and general practitioners . however , educational and supervised practices targeting otoscopy competency during audiology graduate coursework are lacking . also , no studies have attempted to determine otoscopy skills among audiology students . to determine the effectiveness of the otoscopy training model on clinical competency and confidence level of audiology students in performing and interpreting otoscopy . a combination of experimental treatment design with random assignment of treatment and control groups and delayed treatment for control group . thirty-two first - and second-year audiology graduate students who were enrolled in a pediatric audiology class participated in this study . students were randomly assigned to the control ( n = @ , @ females ) or experimental ( n = @ , @ females ) group . participants in the experimental group received supplementary otoscopy training including didactic otoscopy lectures as well as clinical training using manikin ears . the control group received the same pretest and posttest and then completed a third assessment ( posttest @ ) after receiving the same training . an evaluation of knowledge and skills regarding otoscopy between groups and time was conducted at three times : ( a ) pretraining , ( b ) upon completion of training for the experimental group , ( c ) upon completion of training by the control group . the evaluation consisted of a written exam , a clinical exam , and a self-perception rating of confidence . both written exam scores and clinical exam scores ( otoscopy manikin ) were analyzed via two-way analyses of variance ( anovas ) , whereas chi-square ( ) statistic was conducted to evaluate the effects of training on the confidence level of students of both groups . experimental and control groups demonstrated significant increased overall competency in otoscopy following the otoscopy training model with didactic and laboratory components . posttest confidence ratings showed increases in all groups , and there were no significant differences between groups . the need for supplementary otoscopy training was warranted by low knowledge and clinical competency in otoscopy skills of audiology students as measured by pretest mean scores . after completing the training , both experimental and control groups showed significant improvement in knowledge and competency . results also suggest that perceived confidence ratings may be misleading in determining students ' clinical otoscopy skills .
24,224,992
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "acceptance of healthcare-associated pneumonia ( hcap ) as an entity and the associated risk of infection by potentially multidrug-resistant ( mdr ) organisms such as methicillin-resistant staphylococcus aureus ( mrsa ) , pseudomonas and acinetobacter have been debated .", "we therefore compared patients with hcap , hospital-acquired pneumonia ( hap ) , and ventilator-associated pneumonia ( vap ) enrolled in a trial comparing linezolid with vancomycin for treatment of pneumonia .", "the analysis included all patients who received study drug .", "hcap was defined as pneumonia occurring < @hours into hospitalization and acquired in a long-term care , subacute , or intermediate health care facility ; following recent hospitalization ; or after chronic dialysis .", "data from @ patients ( hcap = @ , hap = @ , vap = @ ) were analyzed .", "compared with hap and vap patients , those with hcap were older , had slightly higher severity scores , and were more likely to have comorbidities .", "pseudomonas aeruginosa was the most common gram-negative organism isolated in all pneumonia classes -lsb- hcap , @/@ ( @ % ) ; hap , @/@ ( @ % ) ; vap , @/@ ( @ % ) ; p = @ -rsb- .", "acinetobacter spp .", "were also found with similar frequencies across pneumonia groups .", "to address potential enrollment bias toward patients with mrsa pneumonia , we grouped patients by presence or absence of mrsa and found little difference in frequencies of pseudomonas and acinetobacter .", "in this population of pneumonia patients , the frequencies of mdr gram-negative pathogens were similar among patients with hcap , hap , or vap .", "our data support inclusion of hcap within nosocomial pneumonia guidelines and the recommendation that empiric antibiotic regimens for hcap should be similar to those for hap and vap ." ]
acceptance of healthcare-associated pneumonia ( hcap ) as an entity and the associated risk of infection by potentially multidrug-resistant ( mdr ) organisms such as methicillin-resistant staphylococcus aureus ( mrsa ) , pseudomonas and acinetobacter have been debated . we therefore compared patients with hcap , hospital-acquired pneumonia ( hap ) , and ventilator-associated pneumonia ( vap ) enrolled in a trial comparing linezolid with vancomycin for treatment of pneumonia . the analysis included all patients who received study drug . hcap was defined as pneumonia occurring < @hours into hospitalization and acquired in a long-term care , subacute , or intermediate health care facility ; following recent hospitalization ; or after chronic dialysis . data from @ patients ( hcap = @ , hap = @ , vap = @ ) were analyzed . compared with hap and vap patients , those with hcap were older , had slightly higher severity scores , and were more likely to have comorbidities . pseudomonas aeruginosa was the most common gram-negative organism isolated in all pneumonia classes -lsb- hcap , @/@ ( @ % ) ; hap , @/@ ( @ % ) ; vap , @/@ ( @ % ) ; p = @ -rsb- . acinetobacter spp . were also found with similar frequencies across pneumonia groups . to address potential enrollment bias toward patients with mrsa pneumonia , we grouped patients by presence or absence of mrsa and found little difference in frequencies of pseudomonas and acinetobacter . in this population of pneumonia patients , the frequencies of mdr gram-negative pathogens were similar among patients with hcap , hap , or vap . our data support inclusion of hcap within nosocomial pneumonia guidelines and the recommendation that empiric antibiotic regimens for hcap should be similar to those for hap and vap .
24,279,701
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the higher risk of adverse outcomes after transapical ( ta ) versus transfemoral ( tf ) transcatheter aortic valve replacement ( tavr ) could be attributable to ta-tavr being an open surgical procedure or to clinical differences between ta - and tf-tavr patients .", "we compared outcomes after neutralizing patient differences using propensity score matching .", "from april @ to february @ , @ placement of aortic transcatheter valves ( partner ) - i patients underwent ta-tavr and @ underwent tf-tavr with edwards sapien balloon-expandable bioprostheses .", "propensity matching based on @ preprocedural variables , exclusive of femoral access morphology , identified @ well-matched patient pairs ( @ % of possible matches ) , @ % of whom had peripheral arterial disease .", "matched ta-tavr patients experienced more adverse procedural events , longer length of stay ( @ versus @ days ; p < @ ) , and slower recovery ( new york heart association class i , @ % versus @ % at @ days , equalizing by @ months at @ % versus @ % ) ; stroke risk was similar ( @ % versus @ % at @ days and @ % versus @ % at @ years ) ; mortality was elevated for the first @ postprocedural months ( @ % versus @ % ; p = @ ) ; but aortic regurgitation was less ( @ % versus @ % mild and @ % versus @ % moderate to severe at discharge , p = @ ; @ % versus @ % mild and @ % versus @ % moderate to severe at @ months , p < @ ) .", "the likelihood of adverse periprocedural events and prolonged recovery is greater after ta-tavr than tf-tavr in vasculopathic patients after accounting for differences in cardiovascular risk factors , although stroke risk is equivalent and aortic regurgitation is less .", "as smaller delivery systems permit tf-tavr in many of these patients , we recommend a tf-first access strategy for tavr when anatomically feasible .", "url : http://www.clinicaltrials.gov .", "unique identifier : nct@ ." ]
the higher risk of adverse outcomes after transapical ( ta ) versus transfemoral ( tf ) transcatheter aortic valve replacement ( tavr ) could be attributable to ta-tavr being an open surgical procedure or to clinical differences between ta - and tf-tavr patients . we compared outcomes after neutralizing patient differences using propensity score matching . from april @ to february @ , @ placement of aortic transcatheter valves ( partner ) - i patients underwent ta-tavr and @ underwent tf-tavr with edwards sapien balloon-expandable bioprostheses . propensity matching based on @ preprocedural variables , exclusive of femoral access morphology , identified @ well-matched patient pairs ( @ % of possible matches ) , @ % of whom had peripheral arterial disease . matched ta-tavr patients experienced more adverse procedural events , longer length of stay ( @ versus @ days ; p < @ ) , and slower recovery ( new york heart association class i , @ % versus @ % at @ days , equalizing by @ months at @ % versus @ % ) ; stroke risk was similar ( @ % versus @ % at @ days and @ % versus @ % at @ years ) ; mortality was elevated for the first @ postprocedural months ( @ % versus @ % ; p = @ ) ; but aortic regurgitation was less ( @ % versus @ % mild and @ % versus @ % moderate to severe at discharge , p = @ ; @ % versus @ % mild and @ % versus @ % moderate to severe at @ months , p < @ ) . the likelihood of adverse periprocedural events and prolonged recovery is greater after ta-tavr than tf-tavr in vasculopathic patients after accounting for differences in cardiovascular risk factors , although stroke risk is equivalent and aortic regurgitation is less . as smaller delivery systems permit tf-tavr in many of these patients , we recommend a tf-first access strategy for tavr when anatomically feasible . url : http://www.clinicaltrials.gov . unique identifier : nct@ .
25,832,034
[ "BACKGROUND", "BACKGROUND", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND" ]
[ "the most dreaded hemorrhagic complication in endoscopic endonasal surgery is injury to the internal carotid artery ( ica ) .", "although a number of treatment protocols are currently used , none have been formally investigated .", "this study aims to compare the efficacy of the muscle patch , bipolar diathermy , and aneurysm clip on hemostasis , pseudoaneurysm formation , and long-term vessel patency for different injury types in a sheep model of carotid bleeding .", "twenty-seven sheep underwent ica dissection/isolation followed by the artery placement within a modified `` sinus model otorhino neuro trainer '' ( simont ) model .", "standardized linear , punch , and stellate injuries were made .", "randomization of sheep to receive @ of @ hemostatic techniques was performed ( muscle , bipolar , clip ) .", "specific outcome measures included attainment of primary hemostasis , time to hemostasis , blood loss , pseudoaneurysm formation , and carotid patency on follow-up magnetic resonance imaging ( mri ) .", "bipolar achieved primary hemostasis in @ of @ cases and @ cases of secondary hemorrhage .", "it had no associated pseudoaneurysm formation .", "carotid patency was variable on follow-up mri .", "muscle patch achieved @ % primary hemostasis with @ cases of secondary hemorrhage .", "there were @ cases of pseudoaneurysm and @ % patency rate on follow-up mri .", "aneurysm clip achieved @ % primary hemostasis with @ case of secondary hemorrhage .", "no pseudoaneurysm formation and a @ % rate of carotid insufficiency on mri .", "this study shows that the crushed muscle patch and aneurysm clip can be viable options in the management of ica injury with short-term and long-term benefits .", "complications associated with these techniques were comparable if not reduced when compared to the published literature ." ]
the most dreaded hemorrhagic complication in endoscopic endonasal surgery is injury to the internal carotid artery ( ica ) . although a number of treatment protocols are currently used , none have been formally investigated . this study aims to compare the efficacy of the muscle patch , bipolar diathermy , and aneurysm clip on hemostasis , pseudoaneurysm formation , and long-term vessel patency for different injury types in a sheep model of carotid bleeding . twenty-seven sheep underwent ica dissection/isolation followed by the artery placement within a modified `` sinus model otorhino neuro trainer '' ( simont ) model . standardized linear , punch , and stellate injuries were made . randomization of sheep to receive @ of @ hemostatic techniques was performed ( muscle , bipolar , clip ) . specific outcome measures included attainment of primary hemostasis , time to hemostasis , blood loss , pseudoaneurysm formation , and carotid patency on follow-up magnetic resonance imaging ( mri ) . bipolar achieved primary hemostasis in @ of @ cases and @ cases of secondary hemorrhage . it had no associated pseudoaneurysm formation . carotid patency was variable on follow-up mri . muscle patch achieved @ % primary hemostasis with @ cases of secondary hemorrhage . there were @ cases of pseudoaneurysm and @ % patency rate on follow-up mri . aneurysm clip achieved @ % primary hemostasis with @ case of secondary hemorrhage . no pseudoaneurysm formation and a @ % rate of carotid insufficiency on mri . this study shows that the crushed muscle patch and aneurysm clip can be viable options in the management of ica injury with short-term and long-term benefits . complications associated with these techniques were comparable if not reduced when compared to the published literature .
24,678,066
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the hemostatic and inflammatory systems may activate each other .", "endometriosis is a chronic inflammatory disease affecting @ % of women .", "the objective of this study was to compare the hemostatic effects of two treatments widely prescribed to women with endometriosis : the levonorgestrel intrauterine system ( lng-ius ) and the gonadotropin-releasing hormone analog ( gnrha ) leuprolide acetate .", "in this randomized open-label controlled trial , @ women with endometriosis were randomly allocated to one of two groups : @ women were assigned to use lng-ius and @ to use gnrha .", "the assessed variables were d-dimers , fibrinogen , prothrombin time , activated partial thromboplastin time , coagulation factors ( f ) ii , v , vii , viii , ix , x , and xi , antithrombin ( at ) , protein c , free protein s , tissue plasminogen activator ( t-pa ) , @-antiplasmin , thrombin-antithrombin complex , and prothrombin fragment @ +@ .", "all variables were assessed before treatment and six months after treatment onset .", "in the lng-ius group , fviii decreased @ % after six months of use .", "in the gnrha group , there was a @ % increase in at , @ % reduction in d-dimers , and @ % increase in t-pa .", "the lng-ius users exhibited a significantly greater reduction of fviii than the gnrha users ( lng-ius : -@ @ % vs. gnrha : @ @ % , p = @ ) .", "the women in the gnrha group exhibited a greater increase of at than the lng-ius users ( lng-ius : -@ @ % vs. gnrha : @ @ % , p = @ ) .", "both hormonal treatments for endometriosis exhibited no association with a procoagulant profile ." ]
the hemostatic and inflammatory systems may activate each other . endometriosis is a chronic inflammatory disease affecting @ % of women . the objective of this study was to compare the hemostatic effects of two treatments widely prescribed to women with endometriosis : the levonorgestrel intrauterine system ( lng-ius ) and the gonadotropin-releasing hormone analog ( gnrha ) leuprolide acetate . in this randomized open-label controlled trial , @ women with endometriosis were randomly allocated to one of two groups : @ women were assigned to use lng-ius and @ to use gnrha . the assessed variables were d-dimers , fibrinogen , prothrombin time , activated partial thromboplastin time , coagulation factors ( f ) ii , v , vii , viii , ix , x , and xi , antithrombin ( at ) , protein c , free protein s , tissue plasminogen activator ( t-pa ) , @-antiplasmin , thrombin-antithrombin complex , and prothrombin fragment @ +@ . all variables were assessed before treatment and six months after treatment onset . in the lng-ius group , fviii decreased @ % after six months of use . in the gnrha group , there was a @ % increase in at , @ % reduction in d-dimers , and @ % increase in t-pa . the lng-ius users exhibited a significantly greater reduction of fviii than the gnrha users ( lng-ius : -@ @ % vs. gnrha : @ @ % , p = @ ) . the women in the gnrha group exhibited a greater increase of at than the lng-ius users ( lng-ius : -@ @ % vs. gnrha : @ @ % , p = @ ) . both hormonal treatments for endometriosis exhibited no association with a procoagulant profile .
25,283,586
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "elderly patients with st-segment elevation myocardial infarction ( stemi ) have worse outcomes and a greater risk of intracranial bleeding than nonelderly patients .", "baseline characteristics , clinical outcomes , and the relationship of the tenecteplase ( tnk ) dose reduction to the efficacy , safety , and electrocardiographic indicators of reperfusion efficacy were evaluated in stemi patients @ years .", "the stream trial evaluated early presenting stemi patients who could not undergo primary percutaneous coronary intervention within @ hour of first medical contact .", "because of excess intracranial hemorrhage ( ich ) in patients @ years , the dose of tnk was reduced by @ % .", "before dose amendment , there were @ ( @ % ) of @ elderly patients with ich ; @ of these were fatal , whereas no ich occurred in the @ elderly patients who received half-dose tnk postamendment .", "the median extent of st-segment elevation resolution ( @ % ) and proportion of patients with @ mm in the electrocardiogram lead with greatest st-segment elevation was comparable in elderly patients preamendment and postamendment ( @ % vs @ % and @ % vs @ % , respectively ) .", "patients requiring rescue coronary intervention after tnk was also similar ( @ % vs @ % ) .", "the primary composite end point ( @-day all-cause death , cardiogenic shock , congestive heart failure , and reinfarction ) was @ % before versus @ % postamendment .", "our data , from a modest-sized population of elderly stemi patients , indicate that half-dose tnk reduces the likelihood of ich without compromising reperfusion efficacy .", "these observations are hypothesis generating and warrant further confirmation in randomized clinical trials in the elderly ." ]
elderly patients with st-segment elevation myocardial infarction ( stemi ) have worse outcomes and a greater risk of intracranial bleeding than nonelderly patients . baseline characteristics , clinical outcomes , and the relationship of the tenecteplase ( tnk ) dose reduction to the efficacy , safety , and electrocardiographic indicators of reperfusion efficacy were evaluated in stemi patients @ years . the stream trial evaluated early presenting stemi patients who could not undergo primary percutaneous coronary intervention within @ hour of first medical contact . because of excess intracranial hemorrhage ( ich ) in patients @ years , the dose of tnk was reduced by @ % . before dose amendment , there were @ ( @ % ) of @ elderly patients with ich ; @ of these were fatal , whereas no ich occurred in the @ elderly patients who received half-dose tnk postamendment . the median extent of st-segment elevation resolution ( @ % ) and proportion of patients with @ mm in the electrocardiogram lead with greatest st-segment elevation was comparable in elderly patients preamendment and postamendment ( @ % vs @ % and @ % vs @ % , respectively ) . patients requiring rescue coronary intervention after tnk was also similar ( @ % vs @ % ) . the primary composite end point ( @-day all-cause death , cardiogenic shock , congestive heart failure , and reinfarction ) was @ % before versus @ % postamendment . our data , from a modest-sized population of elderly stemi patients , indicate that half-dose tnk reduces the likelihood of ich without compromising reperfusion efficacy . these observations are hypothesis generating and warrant further confirmation in randomized clinical trials in the elderly .
26,027,628
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the aim of this study was to compare the efficacy , safety , antiplaque and antigingivitis properties of a herbal mouthwash with chlorhexidine mouthwash .", "a double-blinded randomized clinical trial was conducted among @ undergraduate students with age group @-@ years .", "they were randomly divided into three mouthwash group with @ participants in each group .", "group a ( herbal ) , group b ( chlorhexidine ) and group c ( normal saline ) .", "the turesky et al. @ plaque index and loe and silness @ gingival index was recorded .", "student 's t-test and one-way anova were used to test the significance .", "a statistically highly significant difference was obtained between mouthwash b and c ( p = @ ) and a significant difference between mouthwash a and c ( p = @ ) , showing that chlorhexidine was superior to herbal mouthwash and saline .", "however , there was a nonsignificant difference between mouthwash a and b ( p = @ ) showing that herbal and chlorhexidine mouthwash was equally effective in reducing plaque and gingivitis .", "the efficacy of herbal mouthwash was equally effective in reducing plaque and gingivitis as compared to chlorhexidine mouthwash and may be considered as a good alternative .", "the chlorhexidine mouthwash was reported with many side effects which limits its acceptability and long-term use , whereas the presently tested herbal mouthwash had no side effects apart from mild burning sensation ." ]
the aim of this study was to compare the efficacy , safety , antiplaque and antigingivitis properties of a herbal mouthwash with chlorhexidine mouthwash . a double-blinded randomized clinical trial was conducted among @ undergraduate students with age group @-@ years . they were randomly divided into three mouthwash group with @ participants in each group . group a ( herbal ) , group b ( chlorhexidine ) and group c ( normal saline ) . the turesky et al. @ plaque index and loe and silness @ gingival index was recorded . student 's t-test and one-way anova were used to test the significance . a statistically highly significant difference was obtained between mouthwash b and c ( p = @ ) and a significant difference between mouthwash a and c ( p = @ ) , showing that chlorhexidine was superior to herbal mouthwash and saline . however , there was a nonsignificant difference between mouthwash a and b ( p = @ ) showing that herbal and chlorhexidine mouthwash was equally effective in reducing plaque and gingivitis . the efficacy of herbal mouthwash was equally effective in reducing plaque and gingivitis as compared to chlorhexidine mouthwash and may be considered as a good alternative . the chlorhexidine mouthwash was reported with many side effects which limits its acceptability and long-term use , whereas the presently tested herbal mouthwash had no side effects apart from mild burning sensation .
24,698,829
[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "exposure to trauma reminders has been considered imperative in psychotherapy for posttraumatic stress disorder ( ptsd ) .", "the authors tested interpersonal psychotherapy ( ipt ) , which has demonstrated antidepressant efficacy and shown promise in pilot ptsd research as a non-exposure-based non-cognitive-behavioral ptsd treatment .", "the authors conducted a randomized @-week trial comparing ipt , prolonged exposure ( an exposure-based exemplar ) , and relaxation therapy ( an active control psychotherapy ) in @ unmedicated patients who had chronic ptsd and a score > @ on the clinician-administered ptsd scale ( caps ) .", "randomization stratified for comorbid major depression .", "the authors hypothesized that ipt would be no more than minimally inferior ( a difference < @ points in caps score ) to prolonged exposure .", "all therapies had large within-group effect sizes ( d values , @-@ @ ) .", "rates of response , defined as an improvement of > @ % in caps score , were @ % for ipt , @ % for prolonged exposure , and @ % for relaxation therapy ( not significantly different between groups ) .", "caps outcomes for ipt and prolonged exposure differed by @ points ( not significant ) , and the null hypothesis of more than minimal ipt inferiority was rejected ( p = @ ) .", "patients with comorbid major depression were nine times more likely than nondepressed patients to drop out of prolonged exposure therapy .", "ipt and prolonged exposure improved quality of life and social functioning more than relaxation therapy .", "this study demonstrated noninferiority of individual ipt for ptsd compared with the gold-standard treatment .", "ipt had ( nonsignificantly ) lower attrition and higher response rates than prolonged exposure .", "contrary to widespread clinical belief , ptsd treatment may not require cognitive-behavioral exposure to trauma reminders .", "moreover , patients with comorbid major depression may fare better with ipt than with prolonged exposure ." ]
exposure to trauma reminders has been considered imperative in psychotherapy for posttraumatic stress disorder ( ptsd ) . the authors tested interpersonal psychotherapy ( ipt ) , which has demonstrated antidepressant efficacy and shown promise in pilot ptsd research as a non-exposure-based non-cognitive-behavioral ptsd treatment . the authors conducted a randomized @-week trial comparing ipt , prolonged exposure ( an exposure-based exemplar ) , and relaxation therapy ( an active control psychotherapy ) in @ unmedicated patients who had chronic ptsd and a score > @ on the clinician-administered ptsd scale ( caps ) . randomization stratified for comorbid major depression . the authors hypothesized that ipt would be no more than minimally inferior ( a difference < @ points in caps score ) to prolonged exposure . all therapies had large within-group effect sizes ( d values , @-@ @ ) . rates of response , defined as an improvement of > @ % in caps score , were @ % for ipt , @ % for prolonged exposure , and @ % for relaxation therapy ( not significantly different between groups ) . caps outcomes for ipt and prolonged exposure differed by @ points ( not significant ) , and the null hypothesis of more than minimal ipt inferiority was rejected ( p = @ ) . patients with comorbid major depression were nine times more likely than nondepressed patients to drop out of prolonged exposure therapy . ipt and prolonged exposure improved quality of life and social functioning more than relaxation therapy . this study demonstrated noninferiority of individual ipt for ptsd compared with the gold-standard treatment . ipt had ( nonsignificantly ) lower attrition and higher response rates than prolonged exposure . contrary to widespread clinical belief , ptsd treatment may not require cognitive-behavioral exposure to trauma reminders . moreover , patients with comorbid major depression may fare better with ipt than with prolonged exposure .
25,677,355
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to investigate the impact of cyclooxygenase-@ ( cox-@ ) inhibitor with - adrenoceptor blocker ( - blocker ) for men with benign prostatic hyperplasia ( bph ) and lower urinary tract symptoms ( luts ) for detecting prostate cancer in men with elevated prostate specific antigen ( psa ) .", "male patients with clinical bph , elevated serum psa ( > @ng/ml ) , and significant luts ( international prostate symptom score -lsb- ipss -rsb- @ ) were randomly assigned to receive doxazosin @mg daily plus celecoxib @mg daily ( study group ) or doxazosin @mg daily alone ( control group ) for @months .", "patients were investigated for the changes in ipss , maximum flow rate ( qmax ) , voided volume , postvoid residual ( pvr ) volume and serum psa from baseline to @months after treatment .", "after the @-month therapy , prostate biopsy was performed in the patients whose psa were still higher than @ng/ml .", "a total of @ patients completed the study .", "the improvement in ipss-voiding was significantly greater in the study group than control group ( p = @ ) .", "in the study group , patients with prostatic hyperplasia or inflammation on the prostate biopsy had a significantly better result than in patients with prostatic adenocarcinoma , typically in the changes of qmax and voided volume ( p = @ and p = @ , respectively ) .", "the psa level in the study group showed significant improvement after treatment ( p < @ ) .", "however , prostate cancer detection rate failed to show any significant difference between the patients whose psa levels decreased or not ( @/@ = @ % vs. @/@ = @ % , respectively , p = @ ) .", "treatment with cox-@ inhibitor and - blocker for @months could not improve prostatic cancer detection rate .", "but it could increase therapeutic effectiveness of luts in men with bph and elevated psa levels .", "the changes in qmax and voided volume after combination treatment were significantly greater in patients with prostatic hyperplasia or inflammation than adenocarcinoma ." ]
to investigate the impact of cyclooxygenase-@ ( cox-@ ) inhibitor with - adrenoceptor blocker ( - blocker ) for men with benign prostatic hyperplasia ( bph ) and lower urinary tract symptoms ( luts ) for detecting prostate cancer in men with elevated prostate specific antigen ( psa ) . male patients with clinical bph , elevated serum psa ( > @ng/ml ) , and significant luts ( international prostate symptom score -lsb- ipss -rsb- @ ) were randomly assigned to receive doxazosin @mg daily plus celecoxib @mg daily ( study group ) or doxazosin @mg daily alone ( control group ) for @months . patients were investigated for the changes in ipss , maximum flow rate ( qmax ) , voided volume , postvoid residual ( pvr ) volume and serum psa from baseline to @months after treatment . after the @-month therapy , prostate biopsy was performed in the patients whose psa were still higher than @ng/ml . a total of @ patients completed the study . the improvement in ipss-voiding was significantly greater in the study group than control group ( p = @ ) . in the study group , patients with prostatic hyperplasia or inflammation on the prostate biopsy had a significantly better result than in patients with prostatic adenocarcinoma , typically in the changes of qmax and voided volume ( p = @ and p = @ , respectively ) . the psa level in the study group showed significant improvement after treatment ( p < @ ) . however , prostate cancer detection rate failed to show any significant difference between the patients whose psa levels decreased or not ( @/@ = @ % vs. @/@ = @ % , respectively , p = @ ) . treatment with cox-@ inhibitor and - blocker for @months could not improve prostatic cancer detection rate . but it could increase therapeutic effectiveness of luts in men with bph and elevated psa levels . the changes in qmax and voided volume after combination treatment were significantly greater in patients with prostatic hyperplasia or inflammation than adenocarcinoma .
24,246,211
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "a variety of analgesic agents are available , and which one can be used in dogs and cats is a highly controversial issue , existing however a fear in the use of opiates due to possible adverse effects that these drugs can cause .", "the aim of this study was to compare the analgesic effect provided by the administration of tramadol or pethidine on early postoperative pain of cats undergoing ovariohysterectomy in a double-blind prospective study .", "fourty-two animals were randomly assigned into three groups .", "pet received pethidine ( @ mg/kg ) , tra @ received tramadol ( @ mg/kg ) and tra @ received tramadol ( @ mg/kg ) ; all intramuscularly and associated with acepromazine ( @ mg/kg ) .", "the efficacy of each analgesic regimen was evaluated prior to surgery ( baseline - tbl ) , during surgery and @ , @ and @ hours after extubation with subjective pain scale , physiologic parameters , serum concentrations of glucose , cortisol and il-@ .", "changes in cardiovascular system were not clinically relevant .", "there were no significant differences in pain scores ( p > @ ) during the study , although the number of rescue analgesia was significantly higher ( p < @ ) at pet group ( @/@ ) than tra @ group ( @/@ ) , whereas in tra @ , two animals ( @/@ ) required additional analgesia .", "the serum cortisol values of pet group were significantly higher at t@h t@h ( p < @ ) and t@h ( p < @ ) when compared to baseline ( induction ) , also it was noticed a significant difference among the groups at t@h ( pet values were higher than tra @ and tra @ ; p < @ ) .", "tramadol provided adequate analgesia and it was more effective than pethidine to at least six hours for the studied animals .", "at the higher dose ( @ mg/kg ) tramadol is probably more effective , since rescue analgesia was not necessary .", "no significant changes were observed physiological parameter that could contraindicate the use of these opioid in described doses , for the feline species ." ]
a variety of analgesic agents are available , and which one can be used in dogs and cats is a highly controversial issue , existing however a fear in the use of opiates due to possible adverse effects that these drugs can cause . the aim of this study was to compare the analgesic effect provided by the administration of tramadol or pethidine on early postoperative pain of cats undergoing ovariohysterectomy in a double-blind prospective study . fourty-two animals were randomly assigned into three groups . pet received pethidine ( @ mg/kg ) , tra @ received tramadol ( @ mg/kg ) and tra @ received tramadol ( @ mg/kg ) ; all intramuscularly and associated with acepromazine ( @ mg/kg ) . the efficacy of each analgesic regimen was evaluated prior to surgery ( baseline - tbl ) , during surgery and @ , @ and @ hours after extubation with subjective pain scale , physiologic parameters , serum concentrations of glucose , cortisol and il-@ . changes in cardiovascular system were not clinically relevant . there were no significant differences in pain scores ( p > @ ) during the study , although the number of rescue analgesia was significantly higher ( p < @ ) at pet group ( @/@ ) than tra @ group ( @/@ ) , whereas in tra @ , two animals ( @/@ ) required additional analgesia . the serum cortisol values of pet group were significantly higher at t@h t@h ( p < @ ) and t@h ( p < @ ) when compared to baseline ( induction ) , also it was noticed a significant difference among the groups at t@h ( pet values were higher than tra @ and tra @ ; p < @ ) . tramadol provided adequate analgesia and it was more effective than pethidine to at least six hours for the studied animals . at the higher dose ( @ mg/kg ) tramadol is probably more effective , since rescue analgesia was not necessary . no significant changes were observed physiological parameter that could contraindicate the use of these opioid in described doses , for the feline species .
25,310,968
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "cd@ + cells confer angiogenic potential and may be beneficial for the treatment of critical limb ischemia ( cli ) .", "however , patient selection , blinding methods and end points for clinical trials are challenging .", "we hypothesized that bilateral intramuscular administration of cytokine-mobilized cd@ + cells in ambulatory patients with refractory cli would be feasible and safe .", "in this double-blind , randomized sham-controlled trial , subjects received subcutaneous injections of granulocyte colony-stimulating factor ( @ g/kg per day ) for @ days , followed by leukapheresis , and intramuscular administration of @-@ million sorted cd@ + cells delivered into both legs .", "control subjects received normal saline injections , sham leukapheresis and intramuscular injection of placebo buffered solution .", "subjects were followed for @ year .", "an aliquot of cd@ + cells was collected from each subject to test for genes associated with cell senescence .", "seventy subjects were screened , of whom @ were eligible .", "subject enrollment was suspended because of a high rate of mobilization failure in subjects randomly assigned to treatment .", "of @ subjects enrolled ( @ randomly assigned to treatment , @ randomly assigned to control ) , there were no differences in serious adverse events at @ months , and blinding was preserved .", "there were non-significant trends toward improved amputation-free survival , @-minute walk distance , walking impairment questionnaire and quality of life in subjects randomly assigned to treatment .", "successful cd@ + mobilizers expressed fewer senescence-associated genes compared with poor mobilizers .", "bilateral administration of autologous cd@ + cells in ambulatory cli subjects was safe , and blinding was preserved .", "however , poor mobilization efficiency combined with high cd@ + senescence suggests futility in this approach ." ]
cd@ + cells confer angiogenic potential and may be beneficial for the treatment of critical limb ischemia ( cli ) . however , patient selection , blinding methods and end points for clinical trials are challenging . we hypothesized that bilateral intramuscular administration of cytokine-mobilized cd@ + cells in ambulatory patients with refractory cli would be feasible and safe . in this double-blind , randomized sham-controlled trial , subjects received subcutaneous injections of granulocyte colony-stimulating factor ( @ g/kg per day ) for @ days , followed by leukapheresis , and intramuscular administration of @-@ million sorted cd@ + cells delivered into both legs . control subjects received normal saline injections , sham leukapheresis and intramuscular injection of placebo buffered solution . subjects were followed for @ year . an aliquot of cd@ + cells was collected from each subject to test for genes associated with cell senescence . seventy subjects were screened , of whom @ were eligible . subject enrollment was suspended because of a high rate of mobilization failure in subjects randomly assigned to treatment . of @ subjects enrolled ( @ randomly assigned to treatment , @ randomly assigned to control ) , there were no differences in serious adverse events at @ months , and blinding was preserved . there were non-significant trends toward improved amputation-free survival , @-minute walk distance , walking impairment questionnaire and quality of life in subjects randomly assigned to treatment . successful cd@ + mobilizers expressed fewer senescence-associated genes compared with poor mobilizers . bilateral administration of autologous cd@ + cells in ambulatory cli subjects was safe , and blinding was preserved . however , poor mobilization efficiency combined with high cd@ + senescence suggests futility in this approach .
25,239,491
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "severe borderline personality disorder is associated with a very high psychosocial and economic burden .", "current treatment guidelines suggest that several manualized treatments , including day hospital mentalization-based treatment ( mbt-dh ) , are effective in these patients .", "however , only two randomized controlled trials have compared manualized mbt-dh with treatment as usual .", "given the relative paucity of data supporting the efficacy and cost-effectiveness of mbt-dh , the possible influence of researcher allegiance in one of the trials , and potential problems with the generalization of findings to mental health systems in other countries , this multi-site randomized trial aims to investigate the efficacy and cost-effectiveness of manualized mbt-dh compared to manualized specialist treatment as usual in the netherlands .", "the trial is being conducted at two sites in the netherlands .", "patients with a dsm-iv-tr diagnosis of borderline personality disorder and a score of@ on the borderline personality disorder severity index were randomly allocated to mbt-dh or treatment as usual .", "the mbt-dh program consists of a maximum of @months ' intensive treatment , followed by a maximum of @months of maintenance therapy .", "specialist treatment as usual is provided by the city crisis service in amsterdam , a service that specializes in treating patients with personality disorders , offering manualized , non-mbt interventions including family interventions , linehan training , social skills training , and pharmacotherapy , without a maximum time limit .", "patients are assessed at baseline and subsequently every @months up to @months after the start of treatment .", "the primary outcome measure is the frequency and severity of manifestations of borderline personality disorder as assessed by the borderline personality disorder severity index .", "secondary outcome measures include parasuicidal behaviour , symptomatic distress , social and interpersonal functioning , personality functioning , attachment , capacity for mentalizing and quality of life .", "cost-effectiveness is assessed in terms of the cost per quality-adjusted life year .", "outcomes will be analyzed using multilevel analyses based on intention-to-treat principles .", "severe borderline personality disorder is a serious psychological disorder that is associated with high burden .", "this multi-site randomized trial will provide further data concerning the efficacy and cost-effectiveness of mbt-dh for these patients .", "ntr@ ." ]
severe borderline personality disorder is associated with a very high psychosocial and economic burden . current treatment guidelines suggest that several manualized treatments , including day hospital mentalization-based treatment ( mbt-dh ) , are effective in these patients . however , only two randomized controlled trials have compared manualized mbt-dh with treatment as usual . given the relative paucity of data supporting the efficacy and cost-effectiveness of mbt-dh , the possible influence of researcher allegiance in one of the trials , and potential problems with the generalization of findings to mental health systems in other countries , this multi-site randomized trial aims to investigate the efficacy and cost-effectiveness of manualized mbt-dh compared to manualized specialist treatment as usual in the netherlands . the trial is being conducted at two sites in the netherlands . patients with a dsm-iv-tr diagnosis of borderline personality disorder and a score of@ on the borderline personality disorder severity index were randomly allocated to mbt-dh or treatment as usual . the mbt-dh program consists of a maximum of @months ' intensive treatment , followed by a maximum of @months of maintenance therapy . specialist treatment as usual is provided by the city crisis service in amsterdam , a service that specializes in treating patients with personality disorders , offering manualized , non-mbt interventions including family interventions , linehan training , social skills training , and pharmacotherapy , without a maximum time limit . patients are assessed at baseline and subsequently every @months up to @months after the start of treatment . the primary outcome measure is the frequency and severity of manifestations of borderline personality disorder as assessed by the borderline personality disorder severity index . secondary outcome measures include parasuicidal behaviour , symptomatic distress , social and interpersonal functioning , personality functioning , attachment , capacity for mentalizing and quality of life . cost-effectiveness is assessed in terms of the cost per quality-adjusted life year . outcomes will be analyzed using multilevel analyses based on intention-to-treat principles . severe borderline personality disorder is a serious psychological disorder that is associated with high burden . this multi-site randomized trial will provide further data concerning the efficacy and cost-effectiveness of mbt-dh for these patients . ntr@ .
24,886,402
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "the objective of the study was to determine whether vitamin d ( vitd ) supplementation during pregnancy affects obstetric and neonatal outcomes .", "the study was conducted at a university hospital in karachi , pakistan .", "the study was a single-center , open-label , randomized , controlled trial of routine care ( group a , @ mg ferrous sulfate and @ mg calcium daily ) vs vitd supplementation ( group b , @ iu vitamin d@ daily ) , started at @ weeks and continued till delivery .", "maternal serum samples of @-hydroxyvitamin d ( @ohd ) were collected at baseline and delivery .", "neonatal vitd status was assessed in cord blood or in neonatal serum samples within @ hours of birth .", "obstetric outcomes included gestational hypertension , gestational diabetes , and preterm labor , and neonatal well-being included small for gestational age , birth weight , length , head circumference , and @ - and @-minute apgar scores .", "of @ gravidae enrolled , @ completed the trial .", "maternal age , vitd status , and gestational age at enrollment were comparable between the two groups .", "at delivery , maternal @ohd was increased in group b ( @ @ ng/dl vs @ @ ng/dl ( p = @ ) compared with group a ( @ @ ng/dl vs @ @ ng/dl , p = @ ) .", "the obstetric outcomes were comparable between the two groups ( p > @ ) .", "neonatal @ohd levels were significantly higher in group b compared with group a ( @ @ ng/dl vs @ @ ng/dl ) .", "there was positive correlation between maternal and neonatal @ohd levels ( r = @ , p = @ ) .", "one - and @-minute apgar scores were significantly higher in group b ( @ @ vs @ @ , p = @ , and @ @ vs @ @ , p = @ , respectively ) .", "neonatal anthropometric parameters were comparable between the two groups ( p > @ ) .", "maternal vitd supplementation improved maternal and neonatal vitd status ." ]
the objective of the study was to determine whether vitamin d ( vitd ) supplementation during pregnancy affects obstetric and neonatal outcomes . the study was conducted at a university hospital in karachi , pakistan . the study was a single-center , open-label , randomized , controlled trial of routine care ( group a , @ mg ferrous sulfate and @ mg calcium daily ) vs vitd supplementation ( group b , @ iu vitamin d@ daily ) , started at @ weeks and continued till delivery . maternal serum samples of @-hydroxyvitamin d ( @ohd ) were collected at baseline and delivery . neonatal vitd status was assessed in cord blood or in neonatal serum samples within @ hours of birth . obstetric outcomes included gestational hypertension , gestational diabetes , and preterm labor , and neonatal well-being included small for gestational age , birth weight , length , head circumference , and @ - and @-minute apgar scores . of @ gravidae enrolled , @ completed the trial . maternal age , vitd status , and gestational age at enrollment were comparable between the two groups . at delivery , maternal @ohd was increased in group b ( @ @ ng/dl vs @ @ ng/dl ( p = @ ) compared with group a ( @ @ ng/dl vs @ @ ng/dl , p = @ ) . the obstetric outcomes were comparable between the two groups ( p > @ ) . neonatal @ohd levels were significantly higher in group b compared with group a ( @ @ ng/dl vs @ @ ng/dl ) . there was positive correlation between maternal and neonatal @ohd levels ( r = @ , p = @ ) . one - and @-minute apgar scores were significantly higher in group b ( @ @ vs @ @ , p = @ , and @ @ vs @ @ , p = @ , respectively ) . neonatal anthropometric parameters were comparable between the two groups ( p > @ ) . maternal vitd supplementation improved maternal and neonatal vitd status .
24,646,102
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "although caloric restriction is a widely used intervention to reduce body weight and insulin resistance , many patients are unable to comply with such dietary therapy for long periods .", "the clinical effectiveness of low-carbohydrate diets was recently described in a position statement of diabetes uk and a scientific review conducted by the american diabetes association .", "however , randomised trials of dietary interventions in japanese patients with type @ diabetes are scarce .", "therefore , the aim of this study was to examine the effects of a non-calorie-restricted , low-carbohydrate diet in japanese patients unable to adhere to a calorie-restricted diet .", "the enrolled patients were randomly allocated to receive a conventional calorie-restricted diet or low-carbohydrate diet .", "the patients received consultations every two months from a registered dietician for six months .", "we compared the effects of the two dietary interventions on glycaemic control and metabolic profiles .", "the hba@c levels decreased significantly from baseline to six months in the low-carbohydrate diet group ( baseline @ % , six months @ % , p = @ ) but not in the calorie-restricted group ( baseline @ % , six months @ % , n.s. ) , ( between-group comparison , p = @ ) .", "the patients in the former group also experienced improvements in their triglyceride levels , without experiencing any major adverse effects or a decline in the quality of life .", "our findings suggest that a low-carbohydrate diet is effective in lowering the hba@c and triglyceride levels in patients with type @ diabetes who are unable to adhere to a calorie-restricted diet ." ]
although caloric restriction is a widely used intervention to reduce body weight and insulin resistance , many patients are unable to comply with such dietary therapy for long periods . the clinical effectiveness of low-carbohydrate diets was recently described in a position statement of diabetes uk and a scientific review conducted by the american diabetes association . however , randomised trials of dietary interventions in japanese patients with type @ diabetes are scarce . therefore , the aim of this study was to examine the effects of a non-calorie-restricted , low-carbohydrate diet in japanese patients unable to adhere to a calorie-restricted diet . the enrolled patients were randomly allocated to receive a conventional calorie-restricted diet or low-carbohydrate diet . the patients received consultations every two months from a registered dietician for six months . we compared the effects of the two dietary interventions on glycaemic control and metabolic profiles . the hba@c levels decreased significantly from baseline to six months in the low-carbohydrate diet group ( baseline @ % , six months @ % , p = @ ) but not in the calorie-restricted group ( baseline @ % , six months @ % , n.s. ) , ( between-group comparison , p = @ ) . the patients in the former group also experienced improvements in their triglyceride levels , without experiencing any major adverse effects or a decline in the quality of life . our findings suggest that a low-carbohydrate diet is effective in lowering the hba@c and triglyceride levels in patients with type @ diabetes who are unable to adhere to a calorie-restricted diet .
24,390,522
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "a randomized controlled clinical trial was implemented to evaluate the effectiveness of combined mild hyperthermia therapy ( body core temperature @ c ) and multimodal inpatient rehabilitation for patients suffering from chronic low back pain when compared to multimodal pain therapy alone .", "a total of @patients were randomly assigned to the combined or single therapeutic schemes according to a block randomization scheme .", "according to the trial inclusion criteria all patients suffered from chronic low back pain and showed morphological degeneration .", "all patients underwent a @-day inpatient multimodal pain therapy , which was complemented with a @-session schedule of mild hyperthermia therapy for the intervention group ( @h at @ c ) .", "on admission and @months after treatment the study patients were asked to complete an interview assessment with the oswestry low back pain disability questionnaire ( oswestry disability index ) .", "the change in the oswestry disability index total score ( % ) @months after versus before therapy was defined as the primary clinical endpoint of the investigation .", "the patients in the control group and in the intervention group had a median age of @years .", "in the intervention group @ % of the patients were female and @ % reported having half to full time employment compared to @ % and @ % in the control group , respectively .", "on admission the control patients reported a median oswestry disability index of @ % and on recall the same of @ % .", "the intervention group showed median oswestry disability index estimates of @ % and @ % , respectively .", "the changes in the overall oswestry disability index after @months differed significantly with an estimated @ % for the intervention group versus @ % for the control group ( wilcoxon p = @ ) .", "when combined with a multimodal inpatient lower back pain functional therapy in patients showing morphological degeneration , the mild hyperthermia therapy demonstrated statistically significant , although not clinically relevant benefits in comparison to the multimodal treatment alone .", "however , regarding the moderate overall patient-related benefits as measured in terms of the oswestry disability index , the benefit of the underlying multimodal therapy concept implementation must be critically discussed irrespective of its combination with mild hyperthermia therapy ." ]
a randomized controlled clinical trial was implemented to evaluate the effectiveness of combined mild hyperthermia therapy ( body core temperature @ c ) and multimodal inpatient rehabilitation for patients suffering from chronic low back pain when compared to multimodal pain therapy alone . a total of @patients were randomly assigned to the combined or single therapeutic schemes according to a block randomization scheme . according to the trial inclusion criteria all patients suffered from chronic low back pain and showed morphological degeneration . all patients underwent a @-day inpatient multimodal pain therapy , which was complemented with a @-session schedule of mild hyperthermia therapy for the intervention group ( @h at @ c ) . on admission and @months after treatment the study patients were asked to complete an interview assessment with the oswestry low back pain disability questionnaire ( oswestry disability index ) . the change in the oswestry disability index total score ( % ) @months after versus before therapy was defined as the primary clinical endpoint of the investigation . the patients in the control group and in the intervention group had a median age of @years . in the intervention group @ % of the patients were female and @ % reported having half to full time employment compared to @ % and @ % in the control group , respectively . on admission the control patients reported a median oswestry disability index of @ % and on recall the same of @ % . the intervention group showed median oswestry disability index estimates of @ % and @ % , respectively . the changes in the overall oswestry disability index after @months differed significantly with an estimated @ % for the intervention group versus @ % for the control group ( wilcoxon p = @ ) . when combined with a multimodal inpatient lower back pain functional therapy in patients showing morphological degeneration , the mild hyperthermia therapy demonstrated statistically significant , although not clinically relevant benefits in comparison to the multimodal treatment alone . however , regarding the moderate overall patient-related benefits as measured in terms of the oswestry disability index , the benefit of the underlying multimodal therapy concept implementation must be critically discussed irrespective of its combination with mild hyperthermia therapy .
24,389,932
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "probiotics have treatment efficacy in irritable bowel syndrome ( ibs ) , but the exact mechanism remains obscure .", "one hypothesis is the mediation of melatonin levels , leading to changes in ibs symptoms .", "the purpose of this study was to evaluate the effects of a probiotic , vsl # @ , on symptoms , psychological and sleep parameters , and pain sensitivity in ibs , and relate these parameters to in vivo melatonin levels .", "forty-two ibs patients were randomly assigned to receive vsl # @ or placebo for @ weeks .", "subjects completed bowel and psychological questionnaires , underwent rectal sensitivity testing and saliva melatonin assays .", "abdominal pain duration and distension intensity decreased significantly in the probiotic group , along with an increase in rectal distension pain thresholds .", "a correlation between increase in pain tolerance and improvement in abdominal pain scores ( r = @ , p = @ ) was seen with probiotic .", "there was an increase in salivary morning melatonin levels in males treated with vsl # @ , which correlated ( r = @ ) with improved satisfaction in bowel habits .", "when grouped based on baseline diurnal melatonin levels , patients with normal diurnal fluctuations showed an increase in morning melatonin levels with vsl # @ treatment , which significantly correlated with improved satisfaction in bowel habits ( r = @ ) .", "they also had reduced symptom severity scores and abdominal pain duration when treated with vsl # @ , as well as satisfaction with bowel movements and quality-of-life .", "vsl # @ improved symptoms and increased rectal pain thresholds .", "symptom improvement correlated with a rise in morning melatonin , significant in males and subjects with normal circadian rhythm .", "this suggests that probiotics may act by influencing melatonin production , hence modulating ibs symptoms , in individuals with a normal circadian rhythm ." ]
probiotics have treatment efficacy in irritable bowel syndrome ( ibs ) , but the exact mechanism remains obscure . one hypothesis is the mediation of melatonin levels , leading to changes in ibs symptoms . the purpose of this study was to evaluate the effects of a probiotic , vsl # @ , on symptoms , psychological and sleep parameters , and pain sensitivity in ibs , and relate these parameters to in vivo melatonin levels . forty-two ibs patients were randomly assigned to receive vsl # @ or placebo for @ weeks . subjects completed bowel and psychological questionnaires , underwent rectal sensitivity testing and saliva melatonin assays . abdominal pain duration and distension intensity decreased significantly in the probiotic group , along with an increase in rectal distension pain thresholds . a correlation between increase in pain tolerance and improvement in abdominal pain scores ( r = @ , p = @ ) was seen with probiotic . there was an increase in salivary morning melatonin levels in males treated with vsl # @ , which correlated ( r = @ ) with improved satisfaction in bowel habits . when grouped based on baseline diurnal melatonin levels , patients with normal diurnal fluctuations showed an increase in morning melatonin levels with vsl # @ treatment , which significantly correlated with improved satisfaction in bowel habits ( r = @ ) . they also had reduced symptom severity scores and abdominal pain duration when treated with vsl # @ , as well as satisfaction with bowel movements and quality-of-life . vsl # @ improved symptoms and increased rectal pain thresholds . symptom improvement correlated with a rise in morning melatonin , significant in males and subjects with normal circadian rhythm . this suggests that probiotics may act by influencing melatonin production , hence modulating ibs symptoms , in individuals with a normal circadian rhythm .
25,092,036
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "charcot-marie-tooth type @a disease ( cmt@a ) is a rare orphan inherited neuropathy caused by an autosomal dominant duplication of a gene encoding for the structural myelin protein pmp@ , which induces abnormal schwann cell differentiation and dysmyelination , eventually leading to axonal suffering then loss and muscle wasting .", "we favour the idea that diseases can be more efficiently treated when targeting multiple disease-relevant pathways .", "in cmt@a patients , we therefore tested the potential of pxt@ , a low-dose combination of three already approved compounds ( baclofen , naltrexone and sorbitol ) .", "our study conceptually builds on preclinical experiments highlighting a pleiotropic mechanism of action that includes downregulation of pmp@ .", "the primary objective was to assess safety and tolerability of pxt@ .", "the secondary objective aimed at an exploratory analysis of efficacy of pxt@ in cmt@a , to be used for designing next clinical development stages ( phase @b/@ ) .", "@ adult patients with mild-to-moderate cmt@a received in double-blind for @ year placebo or one of the three increasing doses of pxt@ tested , in four equal groups .", "safety and tolerability were assessed with the incidence of related adverse events .", "efficacy was assessed using the charcot-marie-tooth neuropathy score ( cmtns ) and the overall neuropathy limitations scale ( onls ) as main endpoints , as well as various clinical and electrophysiological outcomes .", "this trial confirmed the safety and tolerability of pxt@ .", "the highest dose ( hd ) showed consistent evidence of improvement beyond stabilization .", "cmtns and onls , with a significant improvement of respectively of @ % ( @ % - @ % ) and @ % ( @ % - @ % ) in the hd group versus the pool of all other groups , appear to be the most sensitive clinical endpoints to treatment despite their quasi-stability over one year under placebo .", "patients who did not deteriorate over one year were significantly more frequent in the hd group .", "these results confirm that pxt@ deserves further investigation in adults and could greatly benefit cmt@a-diagnosed children , usually less affected than adults .", "eudract number : @-@-@ .", "clinicaltrials.gov identifier : nct@ .", "the committee for orphan medicinal products issued in february @ a positive opinion on the application for orphan designation for pxt@ ( ema/od/@ / @ ) ." ]
charcot-marie-tooth type @a disease ( cmt@a ) is a rare orphan inherited neuropathy caused by an autosomal dominant duplication of a gene encoding for the structural myelin protein pmp@ , which induces abnormal schwann cell differentiation and dysmyelination , eventually leading to axonal suffering then loss and muscle wasting . we favour the idea that diseases can be more efficiently treated when targeting multiple disease-relevant pathways . in cmt@a patients , we therefore tested the potential of pxt@ , a low-dose combination of three already approved compounds ( baclofen , naltrexone and sorbitol ) . our study conceptually builds on preclinical experiments highlighting a pleiotropic mechanism of action that includes downregulation of pmp@ . the primary objective was to assess safety and tolerability of pxt@ . the secondary objective aimed at an exploratory analysis of efficacy of pxt@ in cmt@a , to be used for designing next clinical development stages ( phase @b/@ ) . @ adult patients with mild-to-moderate cmt@a received in double-blind for @ year placebo or one of the three increasing doses of pxt@ tested , in four equal groups . safety and tolerability were assessed with the incidence of related adverse events . efficacy was assessed using the charcot-marie-tooth neuropathy score ( cmtns ) and the overall neuropathy limitations scale ( onls ) as main endpoints , as well as various clinical and electrophysiological outcomes . this trial confirmed the safety and tolerability of pxt@ . the highest dose ( hd ) showed consistent evidence of improvement beyond stabilization . cmtns and onls , with a significant improvement of respectively of @ % ( @ % - @ % ) and @ % ( @ % - @ % ) in the hd group versus the pool of all other groups , appear to be the most sensitive clinical endpoints to treatment despite their quasi-stability over one year under placebo . patients who did not deteriorate over one year were significantly more frequent in the hd group . these results confirm that pxt@ deserves further investigation in adults and could greatly benefit cmt@a-diagnosed children , usually less affected than adults . eudract number : @-@-@ . clinicaltrials.gov identifier : nct@ . the committee for orphan medicinal products issued in february @ a positive opinion on the application for orphan designation for pxt@ ( ema/od/@ / @ ) .
25,519,680
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND", "BACKGROUND" ]
[ "nacl @ % / @ % hydroxyethyl starch ( hes ) @/@ @ ( hsh ) has shown its beneficial effects in cardiac surgery and immunomodulatory values in experiment and human studies .", "however , there is concern regarding detrimental renal effects of chloride and hes in the intensive care setting .", "the objective of this study was to evaluate the influence of hsh on kidney integrity and the level of inflammatory mediators in on-pump coronary artery bypass surgery patients .", "this was a single-center , prospective , randomized , single-blind pilot study .", "this work was performed at a tertiary cardiothoracic referral center during the period from february to august @ .", "forty patients scheduled for on-pump coronary artery bypass surgery were included .", "patients were randomized to receive once either @ % nacl/@ % hes @/@ @ ( hsh group , n = @ ) or placebo ( @ % nacl ; control group , n = @ ) at a dose of @ mlkg for @ min after anesthesia induction .", "the primary end point was the incidence of acute kidney injury ( aki ) defined according to the kidney disease : improving global outcomes .", "secondary end points were peak serum cystatin c , peak urine neutrophil gelatinase-associated lipocalin , plasma levels of interleukin @ ( il-@ ) , il-@ , intercellular adhesion molecule @ , and endothelial-leukocyte adhesion molecule ( e-selectin ) .", "the incidence of aki within @ h was similar between the groups ( hsh : four patients -lsb- @ % -rsb- ; control : six patients -lsb- @ % -rsb- ) .", "there was a significantly lower peak value for serum cystatin c in the hsh group ( @ -lsb- @-@ @ -rsb- mgl ) compared with the control group ( @ -lsb- @-@ @ -rsb- mgl ; p = @ ) .", "patients in both groups had similar peak postoperative urine neutrophil gelatinase-associated lipocalin concentrations .", "nacl @ % / @ % hydroxyethyl starch @/@ @ significantly reduces levels of il-@ and il-@ at @ h after cardiopulmonary bypass and intercellular adhesion molecule @ and e-selectin at @ h after cardiopulmonary bypass and on postoperative day @ ( p < @ for all ) .", "nacl @ % / @ % hydroxyethyl starch @/@ @ does not lead to the increase in aki incidence when used for the volume therapy in on-pump coronary artery bypass surgery patients .", "nacl @ % / @ % hydroxyethyl starch @/@ @ usage enhanced neither tubular injury nor alteration of glomerular filtration .", "in addition , hsh can reduce the level of the inflammatory mediators after surgery ." ]
nacl @ % / @ % hydroxyethyl starch ( hes ) @/@ @ ( hsh ) has shown its beneficial effects in cardiac surgery and immunomodulatory values in experiment and human studies . however , there is concern regarding detrimental renal effects of chloride and hes in the intensive care setting . the objective of this study was to evaluate the influence of hsh on kidney integrity and the level of inflammatory mediators in on-pump coronary artery bypass surgery patients . this was a single-center , prospective , randomized , single-blind pilot study . this work was performed at a tertiary cardiothoracic referral center during the period from february to august @ . forty patients scheduled for on-pump coronary artery bypass surgery were included . patients were randomized to receive once either @ % nacl/@ % hes @/@ @ ( hsh group , n = @ ) or placebo ( @ % nacl ; control group , n = @ ) at a dose of @ mlkg for @ min after anesthesia induction . the primary end point was the incidence of acute kidney injury ( aki ) defined according to the kidney disease : improving global outcomes . secondary end points were peak serum cystatin c , peak urine neutrophil gelatinase-associated lipocalin , plasma levels of interleukin @ ( il-@ ) , il-@ , intercellular adhesion molecule @ , and endothelial-leukocyte adhesion molecule ( e-selectin ) . the incidence of aki within @ h was similar between the groups ( hsh : four patients -lsb- @ % -rsb- ; control : six patients -lsb- @ % -rsb- ) . there was a significantly lower peak value for serum cystatin c in the hsh group ( @ -lsb- @-@ @ -rsb- mgl ) compared with the control group ( @ -lsb- @-@ @ -rsb- mgl ; p = @ ) . patients in both groups had similar peak postoperative urine neutrophil gelatinase-associated lipocalin concentrations . nacl @ % / @ % hydroxyethyl starch @/@ @ significantly reduces levels of il-@ and il-@ at @ h after cardiopulmonary bypass and intercellular adhesion molecule @ and e-selectin at @ h after cardiopulmonary bypass and on postoperative day @ ( p < @ for all ) . nacl @ % / @ % hydroxyethyl starch @/@ @ does not lead to the increase in aki incidence when used for the volume therapy in on-pump coronary artery bypass surgery patients . nacl @ % / @ % hydroxyethyl starch @/@ @ usage enhanced neither tubular injury nor alteration of glomerular filtration . in addition , hsh can reduce the level of the inflammatory mediators after surgery .
24,549,094
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to compare ondansetron with metoclopramide in the treatment of hyperemesis gravidarum .", "we enrolled @ women with hyperemesis gravidarum in a double-blind randomized trial .", "participants were randomized to intravenous @ mg ondansetron or @ mg metoclopramide every @ hours for @ hours .", "participants kept an emesis diary for @ hours ; at @ hours , they expressed their well-being using a @-point visual numeric rating scale and answered an adverse effects questionnaire .", "nausea intensity was evaluated using a @-point visual numeric rating scale at enrollment and at @ , @ , and @ hours .", "primary analysis was on an intention-to-treat basis .", "eighty women each were randomized to ondansetron or metoclopramide .", "median well-being visual numeric rating scale scores were @ ( range , @-@ ) compared with @ ( range , @-@ ) ( p = @ ) and vomiting episodes in the first @ hours were @ ( range , @-@ ) compared with @ ( range , @-@ ) ( p = @ ) for ondansetron compared with metoclopramide , respectively .", "repeat-measures analysis of variance of nausea visual numeric rating scale showed no difference between study drugs ( p = @ ) .", "reported rates of drowsiness ( @ % compared with @ % ; p = @ ; number needed to treat to benefit , @ ) , xerostomia ( @ % compared with @ % ; p < @ ; number needed to treat to benefit , @ ) , and persistent ketonuria at @ hours ( @ % compared with @ % ; p = @ ; number needed to treat to benefit , @ ) were less frequent with ondansetron .", "length of hospital stay was similar .", "ondansetron and metoclopramide demonstrated similar antiemetic and antinauseant effects in hyperemesis gravidarum .", "however , the overall profile , particularly regarding adverse effects , was better with ondansetron .", "in our setting , metoclopramide was significantly less expensive than ondansetron and remained a reasonable antiemetic choice .", "isrcn register , www.isrctn.org , isrctn@ .", "i." ]
to compare ondansetron with metoclopramide in the treatment of hyperemesis gravidarum . we enrolled @ women with hyperemesis gravidarum in a double-blind randomized trial . participants were randomized to intravenous @ mg ondansetron or @ mg metoclopramide every @ hours for @ hours . participants kept an emesis diary for @ hours ; at @ hours , they expressed their well-being using a @-point visual numeric rating scale and answered an adverse effects questionnaire . nausea intensity was evaluated using a @-point visual numeric rating scale at enrollment and at @ , @ , and @ hours . primary analysis was on an intention-to-treat basis . eighty women each were randomized to ondansetron or metoclopramide . median well-being visual numeric rating scale scores were @ ( range , @-@ ) compared with @ ( range , @-@ ) ( p = @ ) and vomiting episodes in the first @ hours were @ ( range , @-@ ) compared with @ ( range , @-@ ) ( p = @ ) for ondansetron compared with metoclopramide , respectively . repeat-measures analysis of variance of nausea visual numeric rating scale showed no difference between study drugs ( p = @ ) . reported rates of drowsiness ( @ % compared with @ % ; p = @ ; number needed to treat to benefit , @ ) , xerostomia ( @ % compared with @ % ; p < @ ; number needed to treat to benefit , @ ) , and persistent ketonuria at @ hours ( @ % compared with @ % ; p = @ ; number needed to treat to benefit , @ ) were less frequent with ondansetron . length of hospital stay was similar . ondansetron and metoclopramide demonstrated similar antiemetic and antinauseant effects in hyperemesis gravidarum . however , the overall profile , particularly regarding adverse effects , was better with ondansetron . in our setting , metoclopramide was significantly less expensive than ondansetron and remained a reasonable antiemetic choice . isrcn register , www.isrctn.org , isrctn@ . i.
24,807,340
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND", "METHODS" ]
[ "to evaluate once-daily nepafenac @ % to prevent and treat ocular pain and inflammation after cataract surgery .", "sixty-five centers in the united states and europe .", "randomized double-masked vehicle - and active-controlled phase @ study .", "patients received nepafenac @ % once daily , nepafenac @ % @ times daily , or their respective vehicles from day -@ to day @ after cataract extraction .", "an additional drop of study drug was administered @ to @ minutes preoperatively .", "the primary endpoint was the percentage of patients with a cure for inflammation ( score of @ for both aqueous cells and flare ) at day @ .", "of randomized patients , @ received nepafenac @ % , @ received nepafenac @ % , and @ and @ received the respective vehicles .", "significantly more nepafenac @ % patients had no inflammation ( @ % versus @ % ) and were pain free ( @ % versus @ % ) at day @ than vehicle patients ( both p < @ ) .", "nepafenac @ % was noninferior to nepafenac @ % for inflammation ( @ % confidence interval -lsb- ci -rsb- , -@ % to @ % ) and pain-free rates ( @ % ci , -@ % to @ % ) .", "at all postoperative visits , fewer treatment failures ( p. @ ) and more clinical successes ( p @ ) were observed with nepafenac @ % versus vehicle .", "nepafenac @ % was well tolerated and had a safety profile comparable to that of nepafenac @ % .", "once-daily nepafenac @ % was noninferior to nepafenac @ % @ times daily for prevention and treatment of ocular inflammation and pain following cataract surgery .", "the safety of nepafenac @ % was comparable to that of nepafenac @ % , with the added convenience of once-daily dosing .", "drs. modi , lehmann , walters , fong , christie , roel , nethery , and reiser have been paid consultants to alcon research , ltd. .", "ms. sager is an employee of alcon research , ltd. .", "drs. tsorbatzoglou , philipson , and traverso have no financial or proprietary interest in any material or method mentioned ." ]
to evaluate once-daily nepafenac @ % to prevent and treat ocular pain and inflammation after cataract surgery . sixty-five centers in the united states and europe . randomized double-masked vehicle - and active-controlled phase @ study . patients received nepafenac @ % once daily , nepafenac @ % @ times daily , or their respective vehicles from day -@ to day @ after cataract extraction . an additional drop of study drug was administered @ to @ minutes preoperatively . the primary endpoint was the percentage of patients with a cure for inflammation ( score of @ for both aqueous cells and flare ) at day @ . of randomized patients , @ received nepafenac @ % , @ received nepafenac @ % , and @ and @ received the respective vehicles . significantly more nepafenac @ % patients had no inflammation ( @ % versus @ % ) and were pain free ( @ % versus @ % ) at day @ than vehicle patients ( both p < @ ) . nepafenac @ % was noninferior to nepafenac @ % for inflammation ( @ % confidence interval -lsb- ci -rsb- , -@ % to @ % ) and pain-free rates ( @ % ci , -@ % to @ % ) . at all postoperative visits , fewer treatment failures ( p. @ ) and more clinical successes ( p @ ) were observed with nepafenac @ % versus vehicle . nepafenac @ % was well tolerated and had a safety profile comparable to that of nepafenac @ % . once-daily nepafenac @ % was noninferior to nepafenac @ % @ times daily for prevention and treatment of ocular inflammation and pain following cataract surgery . the safety of nepafenac @ % was comparable to that of nepafenac @ % , with the added convenience of once-daily dosing . drs. modi , lehmann , walters , fong , christie , roel , nethery , and reiser have been paid consultants to alcon research , ltd. . ms. sager is an employee of alcon research , ltd. . drs. tsorbatzoglou , philipson , and traverso have no financial or proprietary interest in any material or method mentioned .
24,345,529
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND", "BACKGROUND" ]
[ "many inpatients receive little or no rehabilitation on weekends .", "our aim was to determine what effect providing additional saturday rehabilitation during inpatient rehabilitation had on functional independence , quality of life and length of stay compared to @ days per week of rehabilitation .", "this was a multicenter , single-blind ( assessors ) randomized controlled trial with concealed allocation and @-month follow-up conducted in two publically funded metropolitan inpatient rehabilitation facilities in melbourne , australia .", "patients were eligible if they were adults ( aged @ years ) admitted for rehabilitation for any orthopedic , neurological or other disabling conditions excluding those admitted for slow stream rehabilitation/geriatric evaluation and management .", "participants were randomly allocated to usual care monday to friday rehabilitation ( control ) or to monday to saturday rehabilitation ( intervention ) .", "the additional saturday rehabilitation comprised physiotherapy and occupational therapy .", "the primary outcomes were functional independence ( functional independence measure ( fim ) ; measured on an @ to @ point scale ) , health-related quality of life ( eq-@d utility index ; measured on a @ to @ scale , and eq-@d visual analog scale ; measured on a @ to @ scale ) , and patient length of stay .", "outcome measures were assessed on admission , discharge ( primary endpoint ) , and at @ and @ months post discharge .", "we randomly assigned @ adults ( mean ( sd ) age @ ( @ ) years ) to monday to saturday rehabilitation ( n = @ ) or usual care monday to friday rehabilitation ( n = @ ) .", "relative to admission scores , intervention group participants had higher functional independence ( mean difference ( md ) @ , @ % confidence interval ( ci ) @ to @ , p = @ ) and health-related quality of life ( md @ , @ % ci @ to @ , p = @ ) on discharge and may have had a shorter length of stay by @ days ( @ % ci @ to @ , p = @ ) when compared to control group participants .", "intervention group participants were @ % more likely to have achieved a clinically significant change in functional independence of @ fim points or more ( risk ratio ( rr ) @ , @ % ci @ to @ ) and @ % more likely to have achieved a clinically significant change in health-related quality of life ( rr @ , @ % ci @ to @ ) on discharge compared to the control group .", "there was some maintenance of effect for functional independence and health-related quality of life at @-month follow-up but not at @-month follow-up .", "there was no difference in the number of adverse events between the groups ( incidence rate ratio = @ , @ % ci @ to @ ) .", "providing an additional day of rehabilitation improved functional independence and health-related quality of life at discharge and may have reduced length of stay for patients receiving inpatient rehabilitation .", "australian and new zealand clinical trials registry actrn@ please see related commentary : http://www.biomedcentral.com/@/@-@-@-@ ." ]
many inpatients receive little or no rehabilitation on weekends . our aim was to determine what effect providing additional saturday rehabilitation during inpatient rehabilitation had on functional independence , quality of life and length of stay compared to @ days per week of rehabilitation . this was a multicenter , single-blind ( assessors ) randomized controlled trial with concealed allocation and @-month follow-up conducted in two publically funded metropolitan inpatient rehabilitation facilities in melbourne , australia . patients were eligible if they were adults ( aged @ years ) admitted for rehabilitation for any orthopedic , neurological or other disabling conditions excluding those admitted for slow stream rehabilitation/geriatric evaluation and management . participants were randomly allocated to usual care monday to friday rehabilitation ( control ) or to monday to saturday rehabilitation ( intervention ) . the additional saturday rehabilitation comprised physiotherapy and occupational therapy . the primary outcomes were functional independence ( functional independence measure ( fim ) ; measured on an @ to @ point scale ) , health-related quality of life ( eq-@d utility index ; measured on a @ to @ scale , and eq-@d visual analog scale ; measured on a @ to @ scale ) , and patient length of stay . outcome measures were assessed on admission , discharge ( primary endpoint ) , and at @ and @ months post discharge . we randomly assigned @ adults ( mean ( sd ) age @ ( @ ) years ) to monday to saturday rehabilitation ( n = @ ) or usual care monday to friday rehabilitation ( n = @ ) . relative to admission scores , intervention group participants had higher functional independence ( mean difference ( md ) @ , @ % confidence interval ( ci ) @ to @ , p = @ ) and health-related quality of life ( md @ , @ % ci @ to @ , p = @ ) on discharge and may have had a shorter length of stay by @ days ( @ % ci @ to @ , p = @ ) when compared to control group participants . intervention group participants were @ % more likely to have achieved a clinically significant change in functional independence of @ fim points or more ( risk ratio ( rr ) @ , @ % ci @ to @ ) and @ % more likely to have achieved a clinically significant change in health-related quality of life ( rr @ , @ % ci @ to @ ) on discharge compared to the control group . there was some maintenance of effect for functional independence and health-related quality of life at @-month follow-up but not at @-month follow-up . there was no difference in the number of adverse events between the groups ( incidence rate ratio = @ , @ % ci @ to @ ) . providing an additional day of rehabilitation improved functional independence and health-related quality of life at discharge and may have reduced length of stay for patients receiving inpatient rehabilitation . australian and new zealand clinical trials registry actrn@ please see related commentary : http://www.biomedcentral.com/@/@-@-@-@ .
24,228,854
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]
[ "the resourceful adolescent program ( rap ) is a universal , school-based intervention that has been found to produce small to medium effects in the reduction of adolescent depressive symptoms .", "in the present study , we evaluated the effectiveness of a friendship-building skills program -- the peer interpersonal relatedness ( pir ) program -- in producing larger effects when used in conjunction with rap .", "a cluster-randomized controlled trial was used to assign whole classrooms of adolescent participants recruited from sydney secondary schools to @ of @ conditions : ( a ) rap-pir , ( b ) rap-placebo , or ( c ) assessment-only waiting-list control .", "hierarchical linear modeling ( hlm ) was used to analyze the data .", "across the intervention period , rap did not significantly reduce depressive symptoms relative to those students not receiving this intervention .", "rap followed by pir did significantly reduce depressive symptoms relative to those students not receiving pir .", "across the @-month follow-up , the between-group reductions in depressive symptoms were no longer significant .", "at follow-up , participants in the rap-pir condition had achieved significant increases in their school-related life satisfaction and significant increases in social functioning with peers relative to their peers in the other conditions .", "the study provides preliminary support for the effectiveness of the pir program in reducing depressive symptoms when used alongside rap in the short term and in improving social adjustment and school-related life satisfaction in the longer term .", "given the importance of social adjustment in adolescent mental well-being , the pir program represents a potentially important addition to the prevention of depression in youth ." ]
the resourceful adolescent program ( rap ) is a universal , school-based intervention that has been found to produce small to medium effects in the reduction of adolescent depressive symptoms . in the present study , we evaluated the effectiveness of a friendship-building skills program -- the peer interpersonal relatedness ( pir ) program -- in producing larger effects when used in conjunction with rap . a cluster-randomized controlled trial was used to assign whole classrooms of adolescent participants recruited from sydney secondary schools to @ of @ conditions : ( a ) rap-pir , ( b ) rap-placebo , or ( c ) assessment-only waiting-list control . hierarchical linear modeling ( hlm ) was used to analyze the data . across the intervention period , rap did not significantly reduce depressive symptoms relative to those students not receiving this intervention . rap followed by pir did significantly reduce depressive symptoms relative to those students not receiving pir . across the @-month follow-up , the between-group reductions in depressive symptoms were no longer significant . at follow-up , participants in the rap-pir condition had achieved significant increases in their school-related life satisfaction and significant increases in social functioning with peers relative to their peers in the other conditions . the study provides preliminary support for the effectiveness of the pir program in reducing depressive symptoms when used alongside rap in the short term and in improving social adjustment and school-related life satisfaction in the longer term . given the importance of social adjustment in adolescent mental well-being , the pir program represents a potentially important addition to the prevention of depression in youth .
24,491,074
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "it has been proposed that in the same way that conflict between vestibular and visual inputs leads to motion sickness , conflict between motor commands and sensory information associated with these commands may contribute to some chronic pain states .", "attempts to test this hypothesis by artificially inducing a state of sensorimotor incongruence and assessing self-reported pain have yielded equivocal results .", "to help clarify the effect sensorimotor incongruence has on pain we investigated the effect of moving in an environment of induced incongruence on pressure pain thresholds ( ppt ) and the pain experienced immediately on completion of ppt testing .", "thirty-five healthy subjects performed synchronous and asynchronous upper-limb movements with and without mirror visual feedback in random order .", "we measured ppt over the elbow and the pain evoked by testing .", "generalised linear mixed-models were performed for each outcome .", "condition ( four levels ) and baseline values for each outcome were within-subject factors .", "there was no effect of condition on ppt ( p = @ ) or pressure-evoked pain ( p = @ ) .", "a sensitivity analysis using only the first ppt measure after each condition confirmed the result ( p = @ ) .", "inducing a state of movement related sensorimotor incongruence in the upper-limb of healthy volunteers does not influence ppt , nor the pain evoked by testing .", "we found no evidence that sensorimotor incongruence upregulates the nociceptive system in healthy volunteers ." ]
it has been proposed that in the same way that conflict between vestibular and visual inputs leads to motion sickness , conflict between motor commands and sensory information associated with these commands may contribute to some chronic pain states . attempts to test this hypothesis by artificially inducing a state of sensorimotor incongruence and assessing self-reported pain have yielded equivocal results . to help clarify the effect sensorimotor incongruence has on pain we investigated the effect of moving in an environment of induced incongruence on pressure pain thresholds ( ppt ) and the pain experienced immediately on completion of ppt testing . thirty-five healthy subjects performed synchronous and asynchronous upper-limb movements with and without mirror visual feedback in random order . we measured ppt over the elbow and the pain evoked by testing . generalised linear mixed-models were performed for each outcome . condition ( four levels ) and baseline values for each outcome were within-subject factors . there was no effect of condition on ppt ( p = @ ) or pressure-evoked pain ( p = @ ) . a sensitivity analysis using only the first ppt measure after each condition confirmed the result ( p = @ ) . inducing a state of movement related sensorimotor incongruence in the upper-limb of healthy volunteers does not influence ppt , nor the pain evoked by testing . we found no evidence that sensorimotor incongruence upregulates the nociceptive system in healthy volunteers .
24,709,995
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the aim of this study was to evaluate the safety and efficacy of retropubic ( rp ) or transobturator ( to ) midurethral slings ( mus ) in a prospective randomized cohort of turkish women .", "a total of @ women with urodynamic stress urinary incontinence ( sui ) were randomized to undergo either rp or to mus between august @ and february @ in a tertiary referral center by a single surgeon .", "all patients had history , physical examination , urodynamic evaluation and quality of life assessments .", "the validated turkish versions of the seapi , iciq-sf and oab-v@ questionnaires were used .", "the advantage rp and the obtryx to mus systems were used for all rp and to procedures .", "twenty-seven patients were randomized to each group .", "the median follow-up was @ @ months .", "the median hospital stay was @ @ h and median operative time was @ @ min .", "the overall objective and subjective cure rates were @ and @ % , respectively .", "the quality of life of all patients significantly increased after the operation compared to their preoperative status .", "patients with a poorer subjective cure rate were those with mixed urinary incontinence , whose preoperative seapi and oab-v@ scores were significantly higher .", "mus surgery is highly effective and could safely be performed in a cohort of turkish women with sui in subspecialty centers by experienced surgeons .", "there is no significant difference between rp or to applications in terms of safety and efficacy .", "further studies with long-term follow-up data are required ." ]
the aim of this study was to evaluate the safety and efficacy of retropubic ( rp ) or transobturator ( to ) midurethral slings ( mus ) in a prospective randomized cohort of turkish women . a total of @ women with urodynamic stress urinary incontinence ( sui ) were randomized to undergo either rp or to mus between august @ and february @ in a tertiary referral center by a single surgeon . all patients had history , physical examination , urodynamic evaluation and quality of life assessments . the validated turkish versions of the seapi , iciq-sf and oab-v@ questionnaires were used . the advantage rp and the obtryx to mus systems were used for all rp and to procedures . twenty-seven patients were randomized to each group . the median follow-up was @ @ months . the median hospital stay was @ @ h and median operative time was @ @ min . the overall objective and subjective cure rates were @ and @ % , respectively . the quality of life of all patients significantly increased after the operation compared to their preoperative status . patients with a poorer subjective cure rate were those with mixed urinary incontinence , whose preoperative seapi and oab-v@ scores were significantly higher . mus surgery is highly effective and could safely be performed in a cohort of turkish women with sui in subspecialty centers by experienced surgeons . there is no significant difference between rp or to applications in terms of safety and efficacy . further studies with long-term follow-up data are required .
25,170,535
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "pharmacokinetics and bioequivalence of @ mg irbesartan tablets were studied in @ healthy thai male volunteers .", "a single oral dose of one @ mg tablet of the test product and the reference product was given to each volunteer according to a randomized two-way crossover design with @-week wash out period .", "blood samples were collected at predetermined time intervals until @ hours post dose and irbesartan concentration was quantified with a validated hplc method .", "individual plasma irbesartan concentration-time profile was analyzed for pharmacokinetic parameters .", "maximum plasma concentrations ( cmax ) of @,@ and @,@ ng/ml for test and reference , respectively , were achieved .", "areas under the plasma concentration-time curve ; auc@-t and auc@ - were @,@ and @,@ ngh/ml for test and @,@ and @,@ ngh/ml for reference .", "the median tmax was @ hours and @ hours for test and reference , respectively .", "plasma elimination half-lives ( t@/@ ) were @ hours and @ hours for test and reference , respectively .", "primary pharmacokinetic parameters cmax , auc@-t , and auc@ - were tested parametrically by analysis of variance ( anova ) , and it revealed no statistically significant difference ( defined as p < @ ) between the corresponding cmax , auc@-t , and auc@ - with respect to sequence , volunteers , period and formulation .", "the @ % confidence intervals for the ratio of test and reference product of the parameters cmax , auc@-t , and auc@ - were within @ - @ % ( @ - @ % for cmax , @ - @ % for auc@-t and @ - @ % for auc@ - ) .", "the two products were bioequivalent in terms of both rate and extent of drug absorption into systemic circulation ." ]
pharmacokinetics and bioequivalence of @ mg irbesartan tablets were studied in @ healthy thai male volunteers . a single oral dose of one @ mg tablet of the test product and the reference product was given to each volunteer according to a randomized two-way crossover design with @-week wash out period . blood samples were collected at predetermined time intervals until @ hours post dose and irbesartan concentration was quantified with a validated hplc method . individual plasma irbesartan concentration-time profile was analyzed for pharmacokinetic parameters . maximum plasma concentrations ( cmax ) of @,@ and @,@ ng/ml for test and reference , respectively , were achieved . areas under the plasma concentration-time curve ; auc@-t and auc@ - were @,@ and @,@ ngh/ml for test and @,@ and @,@ ngh/ml for reference . the median tmax was @ hours and @ hours for test and reference , respectively . plasma elimination half-lives ( t@/@ ) were @ hours and @ hours for test and reference , respectively . primary pharmacokinetic parameters cmax , auc@-t , and auc@ - were tested parametrically by analysis of variance ( anova ) , and it revealed no statistically significant difference ( defined as p < @ ) between the corresponding cmax , auc@-t , and auc@ - with respect to sequence , volunteers , period and formulation . the @ % confidence intervals for the ratio of test and reference product of the parameters cmax , auc@-t , and auc@ - were within @ - @ % ( @ - @ % for cmax , @ - @ % for auc@-t and @ - @ % for auc@ - ) . the two products were bioequivalent in terms of both rate and extent of drug absorption into systemic circulation .
24,725,445
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to evaluate the efficacy of maintenance therapy with oral micronized progesterone ( omp ) for prolongation of pregnancy in cases of arrested preterm labor .", "ninety women at @-@weeks of singleton pregnancy with intact membranes and arrested preterm labor were randomly allocated to receive omp ( n = @ ) or placebo ( n = @ ) daily until @weeks or delivery , whichever was earlier .", "outcome parameters were compared using student t test , ( @ ) test , fisher exact test , and log-rank ( @ ) test .", "omp significantly prolonged the latency period ( @ vs @ days ; p = @ ) .", "log-rank analysis revealed a significant difference in mean time to delivery between the @ groups ( p = @ ) .", "there were significantly fewer preterm births ( @ % vs @ % ; p = @ ) and low birth weight neonates ( @ % vs @ % ; p = @ ) , and significantly higher mean birth weight ( @ vs @ kg ; p = @ ) in the omp group .", "perinatal outcomes and adverse effects were similar in the @ groups .", "maintenance tocolysis with omp significantly prolonged pregnancy and decreased the number of preterm births .", "clinical trial registry of india : ctri/@/@ / @ ." ]
to evaluate the efficacy of maintenance therapy with oral micronized progesterone ( omp ) for prolongation of pregnancy in cases of arrested preterm labor . ninety women at @-@weeks of singleton pregnancy with intact membranes and arrested preterm labor were randomly allocated to receive omp ( n = @ ) or placebo ( n = @ ) daily until @weeks or delivery , whichever was earlier . outcome parameters were compared using student t test , ( @ ) test , fisher exact test , and log-rank ( @ ) test . omp significantly prolonged the latency period ( @ vs @ days ; p = @ ) . log-rank analysis revealed a significant difference in mean time to delivery between the @ groups ( p = @ ) . there were significantly fewer preterm births ( @ % vs @ % ; p = @ ) and low birth weight neonates ( @ % vs @ % ; p = @ ) , and significantly higher mean birth weight ( @ vs @ kg ; p = @ ) in the omp group . perinatal outcomes and adverse effects were similar in the @ groups . maintenance tocolysis with omp significantly prolonged pregnancy and decreased the number of preterm births . clinical trial registry of india : ctri/@/@ / @ .
24,807,871
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "propofol is commonly used in pediatric sedation , which may cause hypotension during induction .", "our goal was to determine the effect of a preinduction @-ml/kg isotonic fluid bolus on propofol-induced hypotension , assess clinical signs of hypoperfusion during hypotension , and evaluate for age-related propofol dosing differences .", "this prospective , randomized , controlled , nonblinded study was conducted at children 's hospital of illinois .", "patients were children @ to @ months of age who needed sedation for mri or auditory brainstem-evoked response testing .", "the treatment group received a preinduction @-ml/kg isotonic saline bolus before procedure initiation .", "patients were continuously monitored via cardiorespiratory monitor with pulse oximetry and end-tidal carbon dioxide measurements .", "cardiovascular indices and clinical signs of hypoperfusion were compared between groups , and propofol dosing differences were compared between age groups .", "one hundred twenty-six patients were randomly assigned to treatment ( n = @ ) or control ( n = @ ) conditions .", "twelve patients in the treatment group and @ patients in the control group experienced postinduction hypotension , as defined by the pediatric advanced life support guidelines .", "one patient in each group was given volume resuscitation when blood pressure did not improve after a reduction in the propofol infusion rate .", "no hypotensive patients had physical signs of hypoperfusion , and patients@ year of age needed significantly more propofol .", "a @-ml/kg preinduction isotonic saline bolus does not prevent propofol-induced hypotension .", "no clinical signs of hypoperfusion were noted with induced hypotension , and infants@ months old need significantly more propofol per kilogram for procedures ." ]
propofol is commonly used in pediatric sedation , which may cause hypotension during induction . our goal was to determine the effect of a preinduction @-ml/kg isotonic fluid bolus on propofol-induced hypotension , assess clinical signs of hypoperfusion during hypotension , and evaluate for age-related propofol dosing differences . this prospective , randomized , controlled , nonblinded study was conducted at children 's hospital of illinois . patients were children @ to @ months of age who needed sedation for mri or auditory brainstem-evoked response testing . the treatment group received a preinduction @-ml/kg isotonic saline bolus before procedure initiation . patients were continuously monitored via cardiorespiratory monitor with pulse oximetry and end-tidal carbon dioxide measurements . cardiovascular indices and clinical signs of hypoperfusion were compared between groups , and propofol dosing differences were compared between age groups . one hundred twenty-six patients were randomly assigned to treatment ( n = @ ) or control ( n = @ ) conditions . twelve patients in the treatment group and @ patients in the control group experienced postinduction hypotension , as defined by the pediatric advanced life support guidelines . one patient in each group was given volume resuscitation when blood pressure did not improve after a reduction in the propofol infusion rate . no hypotensive patients had physical signs of hypoperfusion , and patients@ year of age needed significantly more propofol . a @-ml/kg preinduction isotonic saline bolus does not prevent propofol-induced hypotension . no clinical signs of hypoperfusion were noted with induced hypotension , and infants@ months old need significantly more propofol per kilogram for procedures .
25,646,201
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "we examined contraceptive use and dual protection in the postpartum period in a prevention of mother to child transmission population and whether it varied by hiv status .", "data are from a prospective study , the south africa hiv antenatal post-test support study .", "pregnant participants were recruited from a government clinic in an urban township , and the analytic sample was @ .", "following enrollment , participants were tested for hiv and administered a questionnaire at baseline and @ weeks postpartum .", "we used generalized linear regression models to examine hiv status and use of modern contraceptives at @ weeks .", "the risk ratio of condom use at @ weeks postpartum was @ -lsb- @ % confidence interval ( ci ) : @-@ @ -rsb- for hiv-positive compared to hiv-negative women .", "the risk ratio for dual protection ( use of a condom and a hormonal method ) was @ ( @ % ci : @-@ @ ) at @ weeks for hiv-positive compared to hiv-negative women .", "hiv positive status may be a motivating factor for women to use condoms and dual protection .", "in this setting where hiv is highly prevalent , it is ever more important that women control the timing and limiting of births so as to preserve the health of the mother and child .", "hiv status may be an important motivating behavioral factor for women to use contraceptives and dual protection in the postpartum period ." ]
we examined contraceptive use and dual protection in the postpartum period in a prevention of mother to child transmission population and whether it varied by hiv status . data are from a prospective study , the south africa hiv antenatal post-test support study . pregnant participants were recruited from a government clinic in an urban township , and the analytic sample was @ . following enrollment , participants were tested for hiv and administered a questionnaire at baseline and @ weeks postpartum . we used generalized linear regression models to examine hiv status and use of modern contraceptives at @ weeks . the risk ratio of condom use at @ weeks postpartum was @ -lsb- @ % confidence interval ( ci ) : @-@ @ -rsb- for hiv-positive compared to hiv-negative women . the risk ratio for dual protection ( use of a condom and a hormonal method ) was @ ( @ % ci : @-@ @ ) at @ weeks for hiv-positive compared to hiv-negative women . hiv positive status may be a motivating factor for women to use condoms and dual protection . in this setting where hiv is highly prevalent , it is ever more important that women control the timing and limiting of births so as to preserve the health of the mother and child . hiv status may be an important motivating behavioral factor for women to use contraceptives and dual protection in the postpartum period .
25,288,035
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the inspiron-i trial is a first-in-man evaluation of the safety and efficacy of the inspiron drug-eluting stent , a sirolimus-eluting stent with abluminal biodegradable polymer coating and thin cobalt-chromium alloy .", "this is a randomised , multicentre comparison between inspiron and a stent with the same metallic structure but without polymer coating or drug elution ( cronus ) .", "the primary objective was to evaluate the in-segment late loss ( lll ) at six months .", "secondary endpoints included percent in-stent obstruction as measured by intravascular ultrasound ( ivus ) at six months and major adverse cardiac events ( mace ) .", "fifty-eight patients were enrolled ( @ lesions ) , @ for inspiron and @ for cronus .", "baseline clinical and angiographic characteristics of both groups were similar .", "at six months , the in-segment lll was reduced in the inspiron group compared to the control group ( @ mm vs. @ mm , respectively ; p < @ ) , as well as the percent neointimal obstruction ( @ % vs. @ % ; p < @ ) .", "at two-year follow-up , incidence of mace was similar between groups ( @ vs. @ % , respectively ; p = @ ) , with lower target lesion revascularisation for inspiron ( @ vs. @ % , respectively ; p = @ ) and no stent thrombosis .", "sirolimus eluted from an abluminal biodegradable polymer on a cobalt-chromium alloy proved effective in reducing restenosis at six months ." ]
the inspiron-i trial is a first-in-man evaluation of the safety and efficacy of the inspiron drug-eluting stent , a sirolimus-eluting stent with abluminal biodegradable polymer coating and thin cobalt-chromium alloy . this is a randomised , multicentre comparison between inspiron and a stent with the same metallic structure but without polymer coating or drug elution ( cronus ) . the primary objective was to evaluate the in-segment late loss ( lll ) at six months . secondary endpoints included percent in-stent obstruction as measured by intravascular ultrasound ( ivus ) at six months and major adverse cardiac events ( mace ) . fifty-eight patients were enrolled ( @ lesions ) , @ for inspiron and @ for cronus . baseline clinical and angiographic characteristics of both groups were similar . at six months , the in-segment lll was reduced in the inspiron group compared to the control group ( @ mm vs. @ mm , respectively ; p < @ ) , as well as the percent neointimal obstruction ( @ % vs. @ % ; p < @ ) . at two-year follow-up , incidence of mace was similar between groups ( @ vs. @ % , respectively ; p = @ ) , with lower target lesion revascularisation for inspiron ( @ vs. @ % , respectively ; p = @ ) and no stent thrombosis . sirolimus eluted from an abluminal biodegradable polymer on a cobalt-chromium alloy proved effective in reducing restenosis at six months .
24,755,382
[ "OBJECTIVE", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "chronic liver disease leads to fibrosis and cirrhosis of the liver .", "this may , in turn , result in chronic liver failure or the development of hepatocellular carcinoma ( hcc ) .", "main risk factors for chronic liver disease are viral hepatitis and alcoholism .", "the present study assessed a randomly selected population in southern germany for risk factors for chronic liver disease such as fatty liver disease , viral hepatis infection and life-style factors .", "in addition , the potential association with elevated liver enzymes was investigated .", "a total of @ subjects ( @ females , @ males ) , aged @ - @ years , participated in the study .", "each subject underwent a standardized ultrasound examination , and anthropometric and biochemical assessments .", "test subjects were randomly selected from the general population of a town in southwestern germany .", "data were acquired from november to december @ without further follow-up .", "several factors were found to be associated with chronic liver disease in the study population .", "alcohol consumption > @ g/d was seen in @ % ( n = @ ) .", "metabolic syndrome was diagnosed in @ % ( n = @ ) .", "the number of people with a bmi greater than @ kg/m ( @ ) was @ % ( n = @ ) .", "the prevalence of subjects with chronic hepatitis b was @ % ( n = @ ) , that of anti-hcv positive patients , @ % ( n = @ ) .", "elevated ggt was seen in @ % ( n = @ ) of the patients .", "prevalence of hepatic steatosis was @ % ( n = @ ) .", "many cases of chronic liver disease could be prevented by healthy nutrition , optimized medical treatment of associated disorders , and prevention strategies such as routine vaccination , in particular , against hepatitis b virus ( hbv ) ." ]
chronic liver disease leads to fibrosis and cirrhosis of the liver . this may , in turn , result in chronic liver failure or the development of hepatocellular carcinoma ( hcc ) . main risk factors for chronic liver disease are viral hepatitis and alcoholism . the present study assessed a randomly selected population in southern germany for risk factors for chronic liver disease such as fatty liver disease , viral hepatis infection and life-style factors . in addition , the potential association with elevated liver enzymes was investigated . a total of @ subjects ( @ females , @ males ) , aged @ - @ years , participated in the study . each subject underwent a standardized ultrasound examination , and anthropometric and biochemical assessments . test subjects were randomly selected from the general population of a town in southwestern germany . data were acquired from november to december @ without further follow-up . several factors were found to be associated with chronic liver disease in the study population . alcohol consumption > @ g/d was seen in @ % ( n = @ ) . metabolic syndrome was diagnosed in @ % ( n = @ ) . the number of people with a bmi greater than @ kg/m ( @ ) was @ % ( n = @ ) . the prevalence of subjects with chronic hepatitis b was @ % ( n = @ ) , that of anti-hcv positive patients , @ % ( n = @ ) . elevated ggt was seen in @ % ( n = @ ) of the patients . prevalence of hepatic steatosis was @ % ( n = @ ) . many cases of chronic liver disease could be prevented by healthy nutrition , optimized medical treatment of associated disorders , and prevention strategies such as routine vaccination , in particular , against hepatitis b virus ( hbv ) .
24,905,107
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "helicobacter pylori infection is an emerging health concern to some northern canadian aboriginal communities and their clinicians .", "clinicians in the north perceive h. pylori infection to be a major clinical problem because they find h. pylori infection in many patients evaluated for common stomach complaints , leading to frequent demand for treatment , which often fails .", "moreover , public health authorities identified the need for information to develop locally appropriate h. pylori control strategies .", "we described adherence and identified barriers to completing treatment among h. pylori-positive participants in a community-based project inspired by local concerns about h. pylori infection risks .", "in @ , @ h. pylori-positive participants ( diagnosed by a breath test , histopathology and/or culture ) of the aklavik h. pylori project were randomised to standard-of-care or sequential treatment .", "we ascertained adherence by interviewing participants using a structured questionnaire .", "we estimated adherence frequencies as the proportion of participants who reported taking either @ % of doses ( perfect adherence ) or @ % of doses ( good adherence ) .", "to compare the proportion with perfect or good adherence in subgroups , we report proportion differences and @ % confidence intervals ( ci ) .", "of @ participants who were interviewed , @ % reported perfect adherence and @ % reported good adherence .", "we observed more frequent perfect adherence for : standard therapy ( @ % ) versus sequential ( @ % ) ; males ( @ % ) versus females ( @ % ) ; participants @-@ years ( @ % ) versus @-@ ( @ % ) .", "proportion differences were @ % ( ci : -@ , @ ) for standard versus sequential therapy ; @ % ( ci : @ , @ ) for male versus female ; and @ % ( ci : @ , @ ) for @-@ versus @-@ years for perfect adherence .", "of the @ participants who reported poor adherence ( < @ % of doses taken ) , the following barriers to treatment were reported : changed mind about taking treatment ( @ % ) , consumption of alcoholic beverages ( @ % ) , nausea ( @ % ) , forgetfulness ( @ % ) , stomach pain ( @ % ) , difficulty in swallowing pills ( @ % ) , no reason ( @ % ) or bad taste of the pills ( @ % ) .", "this analysis suggests that adherence to treatment for eliminating h. pyori infection may vary by regimen and may be influenced by socio-demographic factors .", "these findings add to the small body of evidence pertaining to adherence to h. pylori treatment in arctic aboriginal communities .", "on-going research in additional northern canadian communities will accumulate data for developing recommendations to improve adherence for treatment to eliminate h. pylori infection ." ]
helicobacter pylori infection is an emerging health concern to some northern canadian aboriginal communities and their clinicians . clinicians in the north perceive h. pylori infection to be a major clinical problem because they find h. pylori infection in many patients evaluated for common stomach complaints , leading to frequent demand for treatment , which often fails . moreover , public health authorities identified the need for information to develop locally appropriate h. pylori control strategies . we described adherence and identified barriers to completing treatment among h. pylori-positive participants in a community-based project inspired by local concerns about h. pylori infection risks . in @ , @ h. pylori-positive participants ( diagnosed by a breath test , histopathology and/or culture ) of the aklavik h. pylori project were randomised to standard-of-care or sequential treatment . we ascertained adherence by interviewing participants using a structured questionnaire . we estimated adherence frequencies as the proportion of participants who reported taking either @ % of doses ( perfect adherence ) or @ % of doses ( good adherence ) . to compare the proportion with perfect or good adherence in subgroups , we report proportion differences and @ % confidence intervals ( ci ) . of @ participants who were interviewed , @ % reported perfect adherence and @ % reported good adherence . we observed more frequent perfect adherence for : standard therapy ( @ % ) versus sequential ( @ % ) ; males ( @ % ) versus females ( @ % ) ; participants @-@ years ( @ % ) versus @-@ ( @ % ) . proportion differences were @ % ( ci : -@ , @ ) for standard versus sequential therapy ; @ % ( ci : @ , @ ) for male versus female ; and @ % ( ci : @ , @ ) for @-@ versus @-@ years for perfect adherence . of the @ participants who reported poor adherence ( < @ % of doses taken ) , the following barriers to treatment were reported : changed mind about taking treatment ( @ % ) , consumption of alcoholic beverages ( @ % ) , nausea ( @ % ) , forgetfulness ( @ % ) , stomach pain ( @ % ) , difficulty in swallowing pills ( @ % ) , no reason ( @ % ) or bad taste of the pills ( @ % ) . this analysis suggests that adherence to treatment for eliminating h. pyori infection may vary by regimen and may be influenced by socio-demographic factors . these findings add to the small body of evidence pertaining to adherence to h. pylori treatment in arctic aboriginal communities . on-going research in additional northern canadian communities will accumulate data for developing recommendations to improve adherence for treatment to eliminate h. pylori infection .
24,416,723
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "clinical indications for hydroxyethyl starches ( hes ) in horses include rapid plasma volume expansion and oncotic support during periods of hypoproteinaemia .", "side effects such as coagulopathies associated with hes administration pose limitations to their use in veterinary medicine .", "in man , tetrastarch ( @/@ @ ) has demonstrated less profound effects on coagulation compared with first - and second-generation hes .", "to evaluate the haemostatic and oncotic effects of tetrastarch ( @/@ @ ) administered at @ , @ and @ml/kg bwt in healthy horses .", "randomised crossover experiment .", "tetrastarch ( @/@ @ ) was administered to @ healthy pony mares at @ , @ and @ml/kg bwt with a @-week washout period .", "packed cell volume , plasma total solids , colloid osmotic pressure ( cop ) , platelet count and thromboelastography ( teg ) were measured at baseline , immediately after infusion ( @h ) , and @ , @ , @ , @ , @ and @h after tetrastarch infusion .", "all teg variables remained within normal reference ranges in all @ treatment groups .", "administration of tetrastarch at @ml/kg bwt resulted in a prolonged k-time ( p = @ ) at @h post infusion , and decreased maximum amplitude at @ ( p < @ ) , @ ( p = @ ) , @ ( p = @ ) , @ ( p < @ ) and @h ( p = @ ) post infusion compared with baseline .", "administration of tetrastarch increased mean cop values above baseline in all @ treatment groups , persisting to @ , @ and @h for the @ , @ and @ml/kg bwt doses , respectively .", "although still within established reference ranges , compared with lower dosages , the administration of @ml/kg bwt tetrastarch ( @/@ @ ) is more likely to induce changes in coagulation as measured by teg .", "tetrastarch increased cop at all dosages evaluated in healthy horses .", "tetrastarch ( @/@ @ ) at @ and @ml/kg bwt has potential as a synthetic colloid for resuscitation and provision of oncotic support in horses ." ]
clinical indications for hydroxyethyl starches ( hes ) in horses include rapid plasma volume expansion and oncotic support during periods of hypoproteinaemia . side effects such as coagulopathies associated with hes administration pose limitations to their use in veterinary medicine . in man , tetrastarch ( @/@ @ ) has demonstrated less profound effects on coagulation compared with first - and second-generation hes . to evaluate the haemostatic and oncotic effects of tetrastarch ( @/@ @ ) administered at @ , @ and @ml/kg bwt in healthy horses . randomised crossover experiment . tetrastarch ( @/@ @ ) was administered to @ healthy pony mares at @ , @ and @ml/kg bwt with a @-week washout period . packed cell volume , plasma total solids , colloid osmotic pressure ( cop ) , platelet count and thromboelastography ( teg ) were measured at baseline , immediately after infusion ( @h ) , and @ , @ , @ , @ , @ and @h after tetrastarch infusion . all teg variables remained within normal reference ranges in all @ treatment groups . administration of tetrastarch at @ml/kg bwt resulted in a prolonged k-time ( p = @ ) at @h post infusion , and decreased maximum amplitude at @ ( p < @ ) , @ ( p = @ ) , @ ( p = @ ) , @ ( p < @ ) and @h ( p = @ ) post infusion compared with baseline . administration of tetrastarch increased mean cop values above baseline in all @ treatment groups , persisting to @ , @ and @h for the @ , @ and @ml/kg bwt doses , respectively . although still within established reference ranges , compared with lower dosages , the administration of @ml/kg bwt tetrastarch ( @/@ @ ) is more likely to induce changes in coagulation as measured by teg . tetrastarch increased cop at all dosages evaluated in healthy horses . tetrastarch ( @/@ @ ) at @ and @ml/kg bwt has potential as a synthetic colloid for resuscitation and provision of oncotic support in horses .
24,372,968
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to evaluate the @-month clinical performance of a nanofilled-resin composite with or without glass-fiber layering in restorations of large cavities in posterior teeth of children .", "a total of @ restorations were placed in permanent molar teeth of @ children ( mean age @ years ) with ( frc ; n = @ ) or without ( rc ; n = @ ) fiber layering .", "one operator placed all restorations .", "restorations were evaluated according to the usphs modified-ryge criteria at baseline , @ , @ , @ , @ , and @ months .", "the data were analyzed using fisher 's exact and chi-square tests and outcomes were compared using the cochran-q test ( p < @ ) .", "the @-month survival rates of the restorations were @ % and @ % in the rc and frc groups , respectively .", "nanofilled-resin restorations with or without glass fiber-layering showed similarly high clinical performance .", "no differences were detected between the evaluated criteria when comparing baseline with any of the evaluation periods ( p < @ ) .", "after @ months there were no secondary caries , change in anatomical form or postoperative sensitivity .", "only minor changes for marginal adaptation , marginal discoloration , color match and surface texture were observed .", "it was concluded that nanofilled-resin composite applied with or without glass-fiber layering showed similar and good results in large cavities of posterior permanent teeth in children over a @-month period ." ]
to evaluate the @-month clinical performance of a nanofilled-resin composite with or without glass-fiber layering in restorations of large cavities in posterior teeth of children . a total of @ restorations were placed in permanent molar teeth of @ children ( mean age @ years ) with ( frc ; n = @ ) or without ( rc ; n = @ ) fiber layering . one operator placed all restorations . restorations were evaluated according to the usphs modified-ryge criteria at baseline , @ , @ , @ , @ , and @ months . the data were analyzed using fisher 's exact and chi-square tests and outcomes were compared using the cochran-q test ( p < @ ) . the @-month survival rates of the restorations were @ % and @ % in the rc and frc groups , respectively . nanofilled-resin restorations with or without glass fiber-layering showed similarly high clinical performance . no differences were detected between the evaluated criteria when comparing baseline with any of the evaluation periods ( p < @ ) . after @ months there were no secondary caries , change in anatomical form or postoperative sensitivity . only minor changes for marginal adaptation , marginal discoloration , color match and surface texture were observed . it was concluded that nanofilled-resin composite applied with or without glass-fiber layering showed similar and good results in large cavities of posterior permanent teeth in children over a @-month period .
24,579,274
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "sitting time ( st ) , a form of sedentary behavior , has been identified as a highly prevalent risk factor for multiple sclerosis ( ms ) - related morbidity .", "there is limited information on the efficacy of behavioral interventions for reducing st in persons with ms.", "to examine the efficacy of a behavioral intervention for reducing st in persons with ms in a pilot rct .", "seventy ms patients were randomly assigned to intervention and waitlist control conditions .", "the behavioral intervention was delivered april-september @ via the internet and consisted of a dedicated website and one-on-one skype video chats that taught participants the skills , techniques , and strategies for reducing sedentary behavior based on social cognitive theory .", "st was measured by questions on the abbreviated international physical activity questionnaire ( ipaq ) before and after the @-month rct .", "data were analyzed in spss , version @ in march @ .", "ancova was performed on post-intervention scores controlling for pre-intervention values using an intent-to-treat analysis .", "the group main effect was statistically significant ( f -lsb- @ , @ -rsb- = @ , p < @ , = @ ) and yielded a parameter estimate of @ ( se = @ , t = @ , p < @ ) .", "the adjusted mean scores for intervention and control groups were @ ( @ ) and @ ( @ ) minutes of st , respectively ( d = @ ) .", "we provide the first data on the efficacy of a behavioral intervention for reducing st in ms patients .", "this highlights the importance of designing and testing the effect of behavioral interventions that reduce st on secondary outcomes such as function , symptoms , quality of life , and health status in persons with ms." ]
sitting time ( st ) , a form of sedentary behavior , has been identified as a highly prevalent risk factor for multiple sclerosis ( ms ) - related morbidity . there is limited information on the efficacy of behavioral interventions for reducing st in persons with ms. to examine the efficacy of a behavioral intervention for reducing st in persons with ms in a pilot rct . seventy ms patients were randomly assigned to intervention and waitlist control conditions . the behavioral intervention was delivered april-september @ via the internet and consisted of a dedicated website and one-on-one skype video chats that taught participants the skills , techniques , and strategies for reducing sedentary behavior based on social cognitive theory . st was measured by questions on the abbreviated international physical activity questionnaire ( ipaq ) before and after the @-month rct . data were analyzed in spss , version @ in march @ . ancova was performed on post-intervention scores controlling for pre-intervention values using an intent-to-treat analysis . the group main effect was statistically significant ( f -lsb- @ , @ -rsb- = @ , p < @ , = @ ) and yielded a parameter estimate of @ ( se = @ , t = @ , p < @ ) . the adjusted mean scores for intervention and control groups were @ ( @ ) and @ ( @ ) minutes of st , respectively ( d = @ ) . we provide the first data on the efficacy of a behavioral intervention for reducing st in ms patients . this highlights the importance of designing and testing the effect of behavioral interventions that reduce st on secondary outcomes such as function , symptoms , quality of life , and health status in persons with ms.
25,070,271
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the parallel-group randomized active-controlled clinical study was conducted to compare the effectiveness of two in-hospital range of motion ( rom ) exercise programs following total knee arthroplasty ( tka ) .", "continuous passive motion ( cpm ) is frequently used to increase rom and improve postoperative recovery despite little conclusive scientific evidence .", "in contrast , a new active sling-based rom therapy requires the activation of the knee joint muscles and dynamic joint stabilization .", "it was hypothesized that higher demands on muscle strength and muscle coordination during sling exercise training ( st ) might be advantageous for early recovery following tka .", "a total of @ patients undergoing primary tka were assessed for eligibility .", "thirty-eight patients were randomly assigned to receive st or cpm ( control intervention ) during hospital stay .", "patients were assessed before tka for baseline measurement ( pretest ) , @day before discharge ( posttest ) and @months after tka ( follow-up ) .", "the passive knee flexion range of motion ( pfl ) was the primary outcome measure .", "secondary outcome measures included active knee flexion range of motion , active and passive knee extension rom , static postural control , physical activity , pain , length of hospital stay as well as clinical , functional and quality-of-life outcomes ( sf-@ , hss and womac scores ) .", "data were analyzed according to the intention-to-treat principle .", "differences between the groups were tested for significance by the unpaired student 's t test or an analysis of covariance ( ancova ) adjusted for baseline , weight , sex , age , pain and physical activity .", "a between-group difference could be determined at posttest .", "the pfl was significantly higher by @ ( @ % ci @ to @ ; p = @ ) in the st group .", "no difference between groups in pfl was documented at follow-up .", "furthermore , no significant differences could be observed for any secondary outcome measure at posttest and follow-up .", "st seems to have a clinically relevant beneficial short-term effect on pfl compared to cpm .", "the results support the implementation of st in rehabilitation programs following tka .", "therapy , level @b ." ]
the parallel-group randomized active-controlled clinical study was conducted to compare the effectiveness of two in-hospital range of motion ( rom ) exercise programs following total knee arthroplasty ( tka ) . continuous passive motion ( cpm ) is frequently used to increase rom and improve postoperative recovery despite little conclusive scientific evidence . in contrast , a new active sling-based rom therapy requires the activation of the knee joint muscles and dynamic joint stabilization . it was hypothesized that higher demands on muscle strength and muscle coordination during sling exercise training ( st ) might be advantageous for early recovery following tka . a total of @ patients undergoing primary tka were assessed for eligibility . thirty-eight patients were randomly assigned to receive st or cpm ( control intervention ) during hospital stay . patients were assessed before tka for baseline measurement ( pretest ) , @day before discharge ( posttest ) and @months after tka ( follow-up ) . the passive knee flexion range of motion ( pfl ) was the primary outcome measure . secondary outcome measures included active knee flexion range of motion , active and passive knee extension rom , static postural control , physical activity , pain , length of hospital stay as well as clinical , functional and quality-of-life outcomes ( sf-@ , hss and womac scores ) . data were analyzed according to the intention-to-treat principle . differences between the groups were tested for significance by the unpaired student 's t test or an analysis of covariance ( ancova ) adjusted for baseline , weight , sex , age , pain and physical activity . a between-group difference could be determined at posttest . the pfl was significantly higher by @ ( @ % ci @ to @ ; p = @ ) in the st group . no difference between groups in pfl was documented at follow-up . furthermore , no significant differences could be observed for any secondary outcome measure at posttest and follow-up . st seems to have a clinically relevant beneficial short-term effect on pfl compared to cpm . the results support the implementation of st in rehabilitation programs following tka . therapy , level @b .
24,886,619
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "METHODS" ]
[ "small increases in mean serum creatinine ( scr ) were observed in studies of rheumatoid arthritis patients during tofacitinib treatment .", "these scr changes were investigated and potential mechanisms explored .", "scr values and renal adverse event data were pooled from five phase @ and two long-term extension ( lte ) studies .", "dose-response relationships and association with inflammation ( c-reactive protein ( crp ) ) were explored using phase @ data and confirmed with phase @ data .", "in phase @ , least squares mean scr differences from placebo at month @ were @ and @ mg/dl for tofacitinib @ and @ mg twice daily ( bid ) ( p < @ ) , respectively .", "during months @ to @ , confirmed scr @ % increases over baseline were reported in @ ( @ % ; @ mg bid ) and @ ( @ % ; @ mg bid ) patients .", "generally , elevations plateaued and remained within normal limits throughout phase @ and lte studies .", "exposure-response modeling demonstrated small , reversible effects of tofacitinib on mean scr , and significant ( p < @ ) effects of crp on model parameters .", "phase @ data confirmed that patients with higher baseline crp or greater crp decreases following tofacitinib treatment had the largest increases in scr .", "across phase @ and lte studies , @ tofacitinib-treated patients had clinical acute renal failure ( arf ) , predominantly in the setting of concurrent serious illness .", "tofacitinib treatment was associated with small , reversible mean increases in scr that plateaued early .", "the mechanism behind these scr changes remains unknown , but may involve effects of tofacitinib on inflammation .", "arf occurred infrequently , was associated with concurrent serious illness , and was unrelated to prior scr increases ." ]
small increases in mean serum creatinine ( scr ) were observed in studies of rheumatoid arthritis patients during tofacitinib treatment . these scr changes were investigated and potential mechanisms explored . scr values and renal adverse event data were pooled from five phase @ and two long-term extension ( lte ) studies . dose-response relationships and association with inflammation ( c-reactive protein ( crp ) ) were explored using phase @ data and confirmed with phase @ data . in phase @ , least squares mean scr differences from placebo at month @ were @ and @ mg/dl for tofacitinib @ and @ mg twice daily ( bid ) ( p < @ ) , respectively . during months @ to @ , confirmed scr @ % increases over baseline were reported in @ ( @ % ; @ mg bid ) and @ ( @ % ; @ mg bid ) patients . generally , elevations plateaued and remained within normal limits throughout phase @ and lte studies . exposure-response modeling demonstrated small , reversible effects of tofacitinib on mean scr , and significant ( p < @ ) effects of crp on model parameters . phase @ data confirmed that patients with higher baseline crp or greater crp decreases following tofacitinib treatment had the largest increases in scr . across phase @ and lte studies , @ tofacitinib-treated patients had clinical acute renal failure ( arf ) , predominantly in the setting of concurrent serious illness . tofacitinib treatment was associated with small , reversible mean increases in scr that plateaued early . the mechanism behind these scr changes remains unknown , but may involve effects of tofacitinib on inflammation . arf occurred infrequently , was associated with concurrent serious illness , and was unrelated to prior scr increases .
25,063,045
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to assess safety up to @year of follow-up associated with prasugrel and clopidogrel use in a prospective cohort of patients with acute coronary syndromes ( acs ) .", "between @ and @ , @ patients invasively managed for acs were enrolled in the multicentre swiss acs bleeding cohort , among whom @ patients received either prasugrel or clopidogrel according to current guidelines .", "patients with st-elevation myocardial infarction ( stemi ) preferentially received prasugrel , while those with non-stemi , a history of stroke or transient ischaemic attack , age @years , or weight < @kg received clopidogrel or reduced dose of prasugrel to comply with the prasugrel label .", "after adjustment using propensity scores , the primary end point of clinically relevant bleeding events ( defined as the composite of bleeding academic research consortium , barc , type @ , @ or @ bleeding ) at @year , occurred at a similar rate in both patient groups ( prasugrel/clopidogrel : @ % / @ % ) .", "stratified analyses in subgroups including patients with stemi yielded a similar safety profile .", "after adjusting for baseline variables , no relevant differences in major adverse cardiovascular and cerebrovascular events were observed at @year ( prasugrel/clopidogrel : cardiac death @ % / @ % , myocardial infarction @ % / @ % , revascularisation @ % / @ % , stroke @ % / @ % ) .", "of note , this study was not designed to compare efficacy between prasugrel and clopidogrel .", "in this large prospective acs cohort , patients treated with prasugrel according to current guidelines ( ie , in patients without cerebrovascular disease , old age or underweight ) had a similar safety profile compared with patients treated with clopidogrel .", "spum-acs : nct@ ; comfortable ami : nct@ ." ]
to assess safety up to @year of follow-up associated with prasugrel and clopidogrel use in a prospective cohort of patients with acute coronary syndromes ( acs ) . between @ and @ , @ patients invasively managed for acs were enrolled in the multicentre swiss acs bleeding cohort , among whom @ patients received either prasugrel or clopidogrel according to current guidelines . patients with st-elevation myocardial infarction ( stemi ) preferentially received prasugrel , while those with non-stemi , a history of stroke or transient ischaemic attack , age @years , or weight < @kg received clopidogrel or reduced dose of prasugrel to comply with the prasugrel label . after adjustment using propensity scores , the primary end point of clinically relevant bleeding events ( defined as the composite of bleeding academic research consortium , barc , type @ , @ or @ bleeding ) at @year , occurred at a similar rate in both patient groups ( prasugrel/clopidogrel : @ % / @ % ) . stratified analyses in subgroups including patients with stemi yielded a similar safety profile . after adjusting for baseline variables , no relevant differences in major adverse cardiovascular and cerebrovascular events were observed at @year ( prasugrel/clopidogrel : cardiac death @ % / @ % , myocardial infarction @ % / @ % , revascularisation @ % / @ % , stroke @ % / @ % ) . of note , this study was not designed to compare efficacy between prasugrel and clopidogrel . in this large prospective acs cohort , patients treated with prasugrel according to current guidelines ( ie , in patients without cerebrovascular disease , old age or underweight ) had a similar safety profile compared with patients treated with clopidogrel . spum-acs : nct@ ; comfortable ami : nct@ .
25,794,517
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]
[ "smoking rates , and associated negative health outcomes , are disproportionately high among people with mental illness compared to the general population .", "smoke-free policies within mental health hospitals can positively impact on patients ' motivation and self-efficacy to address their smoking .", "however , without post-discharge support , preadmission smoking behaviours typically resume .", "this protocol describes a randomised controlled trial that aims to assess the efficacy of linking mental health inpatients to community-based smoking cessation supports upon discharge as a means of reducing smoking prevalence .", "eight hundred participants with acute mental illness will be recruited into the randomised controlled trial whilst inpatients at one of four psychiatric inpatient facilities in the state of new south wales , australia .", "after completing a baseline interview , participants will be randomly allocated to receive either : ` supported care ' , a multimodal smoking cessation intervention ; or ` normal care ' , consisting of existing hospital care only .", "the ` supported care ' intervention will consist of a brief motivational interview and a package of self-help material for abstaining from smoking whilst in hospital , and , following discharge , @ weeks of motivational telephone-based counselling , @ weeks of free nicotine replacement therapy , and a referral to the quitline .", "data will be collected at @ , @ and @ months post-discharge via computer-assisted telephone interview .", "the primary outcomes are abstinence from smoking ( @-day point prevalence and prolonged cessation ) , and secondary outcomes comprise daily cigarette consumption , nicotine dependence , quit attempts , and readiness to change smoking behaviour .", "if shown to be effective , the study will provide evidence in support of systemic changes in the provision of smoking cessation care to patients following discharge from psychiatric inpatient facilities .", "australian new zealand clinical trials registry anztcn : actrn@ .", "date registered : @ september @ ." ]
smoking rates , and associated negative health outcomes , are disproportionately high among people with mental illness compared to the general population . smoke-free policies within mental health hospitals can positively impact on patients ' motivation and self-efficacy to address their smoking . however , without post-discharge support , preadmission smoking behaviours typically resume . this protocol describes a randomised controlled trial that aims to assess the efficacy of linking mental health inpatients to community-based smoking cessation supports upon discharge as a means of reducing smoking prevalence . eight hundred participants with acute mental illness will be recruited into the randomised controlled trial whilst inpatients at one of four psychiatric inpatient facilities in the state of new south wales , australia . after completing a baseline interview , participants will be randomly allocated to receive either : ` supported care ' , a multimodal smoking cessation intervention ; or ` normal care ' , consisting of existing hospital care only . the ` supported care ' intervention will consist of a brief motivational interview and a package of self-help material for abstaining from smoking whilst in hospital , and , following discharge , @ weeks of motivational telephone-based counselling , @ weeks of free nicotine replacement therapy , and a referral to the quitline . data will be collected at @ , @ and @ months post-discharge via computer-assisted telephone interview . the primary outcomes are abstinence from smoking ( @-day point prevalence and prolonged cessation ) , and secondary outcomes comprise daily cigarette consumption , nicotine dependence , quit attempts , and readiness to change smoking behaviour . if shown to be effective , the study will provide evidence in support of systemic changes in the provision of smoking cessation care to patients following discharge from psychiatric inpatient facilities . australian new zealand clinical trials registry anztcn : actrn@ . date registered : @ september @ .
24,996,596
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND" ]
[ "the aim was to evaluate the feasibility and safety of early chest tube removal after complete video-assisted thoracic lobectomy ( cvatl ) .", "retrospective analysis was performed on effects of chest tube removal on patients with lung cancer after pulmonary lobectomy between november @ and october @ eligible patients included @ cases for cvatl and @ cases for open thoracic lobectomy .", "patients with cvatl were divided randomly into experimental group ( eg ) and control group ( cg ) , in which @ patients in eg had chest tube removal on the @ nd day after operation ; @ patients in cg had the tube removal when the drainage volume < @ ml/day .", "patients in open thoracic lobectomy group ( og ) had the tubes removal as cg .", "the drainage volumes of the @ st and @ nd @ h after operation , duration of chest tubes , cases of pain alleviation , and recurrent pleural effusions requiring reintervention were measured .", "the average drainage volume of the @ st @ h after operation of cvatl group from eg and cg was significantly reduced than that in og ( @ ml vs. @ ml , p < @ ) .", "the average drainage volume of the @ nd @ h after operation of cg was significantly reduced than that in og ( @ ml vs. @ ml , p < @ ) .", "the average duration of chest tube of cg for @ days showed significant different compared with og for @ days ( p < @ ) .", "chest tube removal in cvatl group increased more chest pain alleviation than og ( @ % vs. @ % , p = @ ) .", "the frequencies of recurrent pleural effusions requiring reintervention were @ % ( @/@ ) , @ % ( @/@ ) and @ % ( @/@ ) , respectively , which had no significant differences between three groups ( p = @ ) .", "complete video-assisted thoracic lobectomy brings less drainage volume after operation .", "early removal of chest tube in cvatl shows feasible and safe and demonstrates that it may reduce postoperative pain and help fast recovery ." ]
the aim was to evaluate the feasibility and safety of early chest tube removal after complete video-assisted thoracic lobectomy ( cvatl ) . retrospective analysis was performed on effects of chest tube removal on patients with lung cancer after pulmonary lobectomy between november @ and october @ eligible patients included @ cases for cvatl and @ cases for open thoracic lobectomy . patients with cvatl were divided randomly into experimental group ( eg ) and control group ( cg ) , in which @ patients in eg had chest tube removal on the @ nd day after operation ; @ patients in cg had the tube removal when the drainage volume < @ ml/day . patients in open thoracic lobectomy group ( og ) had the tubes removal as cg . the drainage volumes of the @ st and @ nd @ h after operation , duration of chest tubes , cases of pain alleviation , and recurrent pleural effusions requiring reintervention were measured . the average drainage volume of the @ st @ h after operation of cvatl group from eg and cg was significantly reduced than that in og ( @ ml vs. @ ml , p < @ ) . the average drainage volume of the @ nd @ h after operation of cg was significantly reduced than that in og ( @ ml vs. @ ml , p < @ ) . the average duration of chest tube of cg for @ days showed significant different compared with og for @ days ( p < @ ) . chest tube removal in cvatl group increased more chest pain alleviation than og ( @ % vs. @ % , p = @ ) . the frequencies of recurrent pleural effusions requiring reintervention were @ % ( @/@ ) , @ % ( @/@ ) and @ % ( @/@ ) , respectively , which had no significant differences between three groups ( p = @ ) . complete video-assisted thoracic lobectomy brings less drainage volume after operation . early removal of chest tube in cvatl shows feasible and safe and demonstrates that it may reduce postoperative pain and help fast recovery .
25,712,847
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to determine the clinical effectiveness of an exercise programme on self-reported hand activity performance in people with hand osteoarthritis ( oa ) .", "in this randomized , controlled trial , participants with physician-confirmed hand oa were randomly allocated to a @-week exercise intervention ( group - and home-based ) or usual care .", "the primary outcome was self-reported hand activity performance at @ months measured by the functional index for hand osteoarthritis ( fihoa ) and a patient-generated measure of disability , the patient-specific functional scale ( psfs ) .", "of @ randomized participants ( mean age @ ( standard deviation ( sd ) @ ) ; female @ % ) , @ ( @ % ) and @ ( @ % ) completed the @ - and @-month follow-ups .", "the adjusted mean difference for the exercise vs control group was -@ points ( @ % confidence interval ( ci ) -@ , @ ) for the fihoa score ( @-@ scale , @ = best ) and @ points ( @ % ci @ , @ ) for the psfs score ( @-@ scale , @ = best ) .", "small significant mean differences in favour of the intervention group were found for hand pain , hand stiffness and disease activity , whereas no mean differences were observed in hand dexterity or maximal grip strength .", "a significantly larger proportion in the intervention ( @ % ) vs control group ( @ % ) fulfilled the outcome measures in rheumatological clinical trials-osteoarthritis research society international ( omeract-oarsi ) responder criteria at @ months ( or = @ , @ % ci @ , @ ) .", "at the @-month follow-up , there were no significant group differences in any outcome .", "the exercise programme was well tolerated among people with hand oa , but resulted only in small , beneficial short-term improvements on self-reported measures and not on most performance-based tests .", "future studies should address optimal grip strength exercises and dosage .", "clinicaltrials.gov registration number : nct@ ." ]
to determine the clinical effectiveness of an exercise programme on self-reported hand activity performance in people with hand osteoarthritis ( oa ) . in this randomized , controlled trial , participants with physician-confirmed hand oa were randomly allocated to a @-week exercise intervention ( group - and home-based ) or usual care . the primary outcome was self-reported hand activity performance at @ months measured by the functional index for hand osteoarthritis ( fihoa ) and a patient-generated measure of disability , the patient-specific functional scale ( psfs ) . of @ randomized participants ( mean age @ ( standard deviation ( sd ) @ ) ; female @ % ) , @ ( @ % ) and @ ( @ % ) completed the @ - and @-month follow-ups . the adjusted mean difference for the exercise vs control group was -@ points ( @ % confidence interval ( ci ) -@ , @ ) for the fihoa score ( @-@ scale , @ = best ) and @ points ( @ % ci @ , @ ) for the psfs score ( @-@ scale , @ = best ) . small significant mean differences in favour of the intervention group were found for hand pain , hand stiffness and disease activity , whereas no mean differences were observed in hand dexterity or maximal grip strength . a significantly larger proportion in the intervention ( @ % ) vs control group ( @ % ) fulfilled the outcome measures in rheumatological clinical trials-osteoarthritis research society international ( omeract-oarsi ) responder criteria at @ months ( or = @ , @ % ci @ , @ ) . at the @-month follow-up , there were no significant group differences in any outcome . the exercise programme was well tolerated among people with hand oa , but resulted only in small , beneficial short-term improvements on self-reported measures and not on most performance-based tests . future studies should address optimal grip strength exercises and dosage . clinicaltrials.gov registration number : nct@ .
25,008,206
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]