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[ "to compare the effects of trimethoprim-sulfamethoxazole vs placebo in reducing the risk of recurrences of toxoplasma gondii retinochoroiditis .", "single-center , prospective randomized double-masked clinical trial .", "a total of @ patients from campinas , brazil , with active recurrent toxoplasma gondii retinochoroiditis were included .", "the initially active toxoplasmosis lesions were successfully treated in all cases using trimethoprim-sulfamethoxazole ( @ mg/@ mg ) twice daily for @ days .", "subsequently , @ patients dropped out of the study .", "the remaining patients were randomized to group @ ( trimethoprim/sulfamethoxazole tablet every @ days ) or group @ ( identical placebo tablet every @ days ) .", "randomization was @:@ , was stratified by sex , and used block sizes of @ .", "the primary outcome was recurrent toxoplasmosis retinochoroiditis within @ year , and the secondary outcome was a @-year change in best-corrected visual acuity ( bcva ) ( etdrs chart ) .", "the incidence of recurrent toxoplasmosis retinochoroiditis within @ months was @ of @ ( @ % ) and @ of @ ( @ % ) in the trimethoprim-sulfamethoxazole and placebo groups , respectively ( p = @ ) .", "visual acuity improvements in the @ groups were similar .", "no treatment-limiting toxicity was observed .", "trimethoprim/sulfamethoxazole therapy resulted in a @ % reduction in the recurrence of toxoplasma gondii retinochoroiditis over @ year of treatment ." ]
to compare the effects of trimethoprim-sulfamethoxazole vs placebo in reducing the risk of recurrences of toxoplasma gondii retinochoroiditis . single-center , prospective randomized double-masked clinical trial . a total of @ patients from campinas , brazil , with active recurrent toxoplasma gondii retinochoroiditis were included . the initially active toxoplasmosis lesions were successfully treated in all cases using trimethoprim-sulfamethoxazole ( @ mg/@ mg ) twice daily for @ days . subsequently , @ patients dropped out of the study . the remaining patients were randomized to group @ ( trimethoprim/sulfamethoxazole tablet every @ days ) or group @ ( identical placebo tablet every @ days ) . randomization was @:@ , was stratified by sex , and used block sizes of @ . the primary outcome was recurrent toxoplasmosis retinochoroiditis within @ year , and the secondary outcome was a @-year change in best-corrected visual acuity ( bcva ) ( etdrs chart ) . the incidence of recurrent toxoplasmosis retinochoroiditis within @ months was @ of @ ( @ % ) and @ of @ ( @ % ) in the trimethoprim-sulfamethoxazole and placebo groups , respectively ( p = @ ) . visual acuity improvements in the @ groups were similar . no treatment-limiting toxicity was observed . trimethoprim/sulfamethoxazole therapy resulted in a @ % reduction in the recurrence of toxoplasma gondii retinochoroiditis over @ year of treatment .
24,388,839
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "antisocial personality is a common adult problem that imposes a major public health burden , but for which there is no effective treatment .", "affected individuals exhibit persistent antisocial behavior and pervasive antisocial character traits , such as irritability , manipulativeness , and lack of remorse .", "prevention of antisocial personality in childhood has been advocated , but evidence for effective interventions is lacking .", "the authors conducted two follow-up studies of randomized trials of group parent training .", "one involved @ clinic-referred @ - to @-year-olds with severe antisocial behavior for whom treatment was indicated , @ of whom were reassessed between ages @ and @ .", "the other involved @ high-risk @ - to @-year-olds with elevated antisocial behavior who were selectively screened from the community , @ of whom were reassessed between ages @ and @ .", "the primary psychiatric outcome measures were the two elements of antisocial personality , namely , antisocial behavior ( assessed by a diagnostic interview ) and antisocial character traits ( assessed by a questionnaire ) .", "also assessed were reading achievement ( an important domain of youth functioning at work ) and parent-adolescent relationship quality .", "in the indicated sample , both elements of antisocial personality were improved in the early intervention group at long-term follow-up compared with the control group ( antisocial behavior : odds ratio of oppositional defiant disorder = @ , @ % ci = @ , @ ; antisocial character traits : b = -@ , @ % ci = -@ , -@ ) .", "additionally , reading ability improved ( b = @ , @ % ci = @ , @ ) .", "parental expressed emotion was warmer ( b = @ , @ % ci = @ , @ ) and supervision was closer ( b = -@ , @ % ci = -@ , -@ ) , but direct observation of parenting showed no differences .", "teacher-rated and self-rated antisocial behavior were unchanged .", "in contrast , in the selective high-risk sample , early intervention was not associated with improved long-term outcomes .", "early intervention with severely antisocial children for whom treatment is indicated may prevent the development of antisocial personality in adolescence and may improve academic performance .", "in contrast , early intervention with selective high-risk samples may be ineffective ." ]
antisocial personality is a common adult problem that imposes a major public health burden , but for which there is no effective treatment . affected individuals exhibit persistent antisocial behavior and pervasive antisocial character traits , such as irritability , manipulativeness , and lack of remorse . prevention of antisocial personality in childhood has been advocated , but evidence for effective interventions is lacking . the authors conducted two follow-up studies of randomized trials of group parent training . one involved @ clinic-referred @ - to @-year-olds with severe antisocial behavior for whom treatment was indicated , @ of whom were reassessed between ages @ and @ . the other involved @ high-risk @ - to @-year-olds with elevated antisocial behavior who were selectively screened from the community , @ of whom were reassessed between ages @ and @ . the primary psychiatric outcome measures were the two elements of antisocial personality , namely , antisocial behavior ( assessed by a diagnostic interview ) and antisocial character traits ( assessed by a questionnaire ) . also assessed were reading achievement ( an important domain of youth functioning at work ) and parent-adolescent relationship quality . in the indicated sample , both elements of antisocial personality were improved in the early intervention group at long-term follow-up compared with the control group ( antisocial behavior : odds ratio of oppositional defiant disorder = @ , @ % ci = @ , @ ; antisocial character traits : b = -@ , @ % ci = -@ , -@ ) . additionally , reading ability improved ( b = @ , @ % ci = @ , @ ) . parental expressed emotion was warmer ( b = @ , @ % ci = @ , @ ) and supervision was closer ( b = -@ , @ % ci = -@ , -@ ) , but direct observation of parenting showed no differences . teacher-rated and self-rated antisocial behavior were unchanged . in contrast , in the selective high-risk sample , early intervention was not associated with improved long-term outcomes . early intervention with severely antisocial children for whom treatment is indicated may prevent the development of antisocial personality in adolescence and may improve academic performance . in contrast , early intervention with selective high-risk samples may be ineffective .
24,626,738
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the authors compared the baby enclosed afferent reservoir ( baby ear ) with the jackson-rees ( jr ) anesthesia circuit for the minimal fresh gas flow ( fgf ) requirement with no and clinically acceptable rebreathing in spontaneous breathing anesthesia among pediatric patients .", "the present study was a randomized crossover study .", "twenty patients , weighing @ to @ kg with asa physical status i-ii were enrolled .", "they were allocated to group @ ( ear-jr ) starting with baby ear then switching to jr or group @ ( jr-ear ) , reversedpattern .", "after induction and intubation , anesthesia was maintainedwith a n@o/o@ combination with sevoflurane @ to @ % and fentanyl .", "starting with the first circuit , all patients were spontaneously ventilated with fgf @ ml/kg/min for @ minutes , and then gradually decreased by @ ml/kg/min every five minutes .", "end-tidal co@ ( etco ) and inspired minimum co@ ( imco ) were recorded until rebreathing ( imco@ > @ mmhg ) occurred and continued until rebreathing was not clinically acceptable ( imco@ > @ mmhg ) .", "the anesthesia breathing circuit was switched and the procedure repeated .", "the minimal fgf at no rebreathing of baby ear and jr were @ and @ ml/kg/min ; p < @ .", "at acceptable rebreathing , the values were @ and @ ml/kg/min ; p < @ .", "baby ear can be used safely , effectively , and requires less fgf than jr in pediatric anesthesia in patients weighing @ to @ kg ." ]
the authors compared the baby enclosed afferent reservoir ( baby ear ) with the jackson-rees ( jr ) anesthesia circuit for the minimal fresh gas flow ( fgf ) requirement with no and clinically acceptable rebreathing in spontaneous breathing anesthesia among pediatric patients . the present study was a randomized crossover study . twenty patients , weighing @ to @ kg with asa physical status i-ii were enrolled . they were allocated to group @ ( ear-jr ) starting with baby ear then switching to jr or group @ ( jr-ear ) , reversedpattern . after induction and intubation , anesthesia was maintainedwith a n@o/o@ combination with sevoflurane @ to @ % and fentanyl . starting with the first circuit , all patients were spontaneously ventilated with fgf @ ml/kg/min for @ minutes , and then gradually decreased by @ ml/kg/min every five minutes . end-tidal co@ ( etco ) and inspired minimum co@ ( imco ) were recorded until rebreathing ( imco@ > @ mmhg ) occurred and continued until rebreathing was not clinically acceptable ( imco@ > @ mmhg ) . the anesthesia breathing circuit was switched and the procedure repeated . the minimal fgf at no rebreathing of baby ear and jr were @ and @ ml/kg/min ; p < @ . at acceptable rebreathing , the values were @ and @ ml/kg/min ; p < @ . baby ear can be used safely , effectively , and requires less fgf than jr in pediatric anesthesia in patients weighing @ to @ kg .
25,675,682
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to study the effects of extensively hydrolyzed protein formula ( ehf ) on the feeding and growth in preterm infants through a multicenter controlled clinical study .", "preterm infants admitted to eight upper first-class hospitals in china between february @ and december @ were randomly selected .", "they were divided into two observation groups and two control groups .", "the first observation group consisted of preterm infants with a gestational age of < @ weeks , who were fed with ehf for @-@ days after birth and then with standard preterm formula ( spf ) until discharge .", "the second observation group consisted of preterm infants with a gestational age of @-@ weeks , who were fed with spf after birth , but were switched to ehf ( @-@ days ) if suffering feeding intolerance at @-@ days after birth .", "the two control groups with corresponding gestational ages kept to be fed with spf after birth .", "clinical data were recorded to compare feeding condition , physical growth , blood biochemical indices , and major complications between different groups .", "a total of @ preterm infants were enrolled .", "preterm infants with a gestational age of < @ weeks in the observation group had a significantly shorter meconium evacuation time than in the corresponding control group ( p < @ ) .", "they also had significantly lower levels of serum total bilirubin at weeks @ and @ after birth compared with the control group ( p < @ ) .", "the observation group needed more time in reaching enteral nutrition ( en ) basic energy uptake of @ kcal / ( kgd ) , partial parenteral nutrition ( ppn ) , hospitalization , and corrected gestational age at discharge compared with the controlled infants ( p < @ ) .", "there was no difference in the incidence of extrauterine growth retardation ( eugr ) at discharge between the two groups ( p > @ ) .", "preterm infants with a gestational age of @-@ weeks in the observation group had significantly lower serum total bilirubin levels at @ weeks after birth compared with the corresponding control group ( p < @ ) .", "they required more time in achieving en basic energy and ppn than in the control group ( p < @ ) .", "there was no difference in the incidence of eugr at discharge between the two groups ( p > @ ) .", "for preterm infants , ehf can improve gastrointestinal motility , accelerate bilirubin metabolism and excretion and does not increase the incidence of eugr ." ]
to study the effects of extensively hydrolyzed protein formula ( ehf ) on the feeding and growth in preterm infants through a multicenter controlled clinical study . preterm infants admitted to eight upper first-class hospitals in china between february @ and december @ were randomly selected . they were divided into two observation groups and two control groups . the first observation group consisted of preterm infants with a gestational age of < @ weeks , who were fed with ehf for @-@ days after birth and then with standard preterm formula ( spf ) until discharge . the second observation group consisted of preterm infants with a gestational age of @-@ weeks , who were fed with spf after birth , but were switched to ehf ( @-@ days ) if suffering feeding intolerance at @-@ days after birth . the two control groups with corresponding gestational ages kept to be fed with spf after birth . clinical data were recorded to compare feeding condition , physical growth , blood biochemical indices , and major complications between different groups . a total of @ preterm infants were enrolled . preterm infants with a gestational age of < @ weeks in the observation group had a significantly shorter meconium evacuation time than in the corresponding control group ( p < @ ) . they also had significantly lower levels of serum total bilirubin at weeks @ and @ after birth compared with the control group ( p < @ ) . the observation group needed more time in reaching enteral nutrition ( en ) basic energy uptake of @ kcal / ( kgd ) , partial parenteral nutrition ( ppn ) , hospitalization , and corrected gestational age at discharge compared with the controlled infants ( p < @ ) . there was no difference in the incidence of extrauterine growth retardation ( eugr ) at discharge between the two groups ( p > @ ) . preterm infants with a gestational age of @-@ weeks in the observation group had significantly lower serum total bilirubin levels at @ weeks after birth compared with the corresponding control group ( p < @ ) . they required more time in achieving en basic energy and ppn than in the control group ( p < @ ) . there was no difference in the incidence of eugr at discharge between the two groups ( p > @ ) . for preterm infants , ehf can improve gastrointestinal motility , accelerate bilirubin metabolism and excretion and does not increase the incidence of eugr .
25,008,873
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to investigate the effect of a computer-supported indirect-form lifestyle-modification program using lifestyle intervention support software for diabetes prevention ( liss-dp ) , as a clinically feasible strategy for primary prevention , on diet and physical activity habits in adults with a family history of type @ diabetes .", "this was a two-arm , randomized controlled trial : ( @ ) lifestyle intervention ( li ) group ( n = @ ) ; ( @ ) control ( n = @ ) .", "healthy adults aged @-@ years with a history of type @ diabetes among their first-degree relatives were recruited .", "li group received three times of lifestyle intervention using liss-dp during six-month intervention period via mail .", "lifestyle intervention group showed significantly greater decrease in energy intake six months after baseline , compared to control ( -@ and -@ kcal/day , respectively , p = @ , cohen 's d = @ ) , though the difference disappeared @ year after from baseline .", "no difference was found in physical activity energy expenditure .", "a computer-based , non-face-to-face lifestyle intervention was effective on dietary habits , only during the intervention period .", "further examination of the long-term effects of such intervention and physical activity is required ." ]
to investigate the effect of a computer-supported indirect-form lifestyle-modification program using lifestyle intervention support software for diabetes prevention ( liss-dp ) , as a clinically feasible strategy for primary prevention , on diet and physical activity habits in adults with a family history of type @ diabetes . this was a two-arm , randomized controlled trial : ( @ ) lifestyle intervention ( li ) group ( n = @ ) ; ( @ ) control ( n = @ ) . healthy adults aged @-@ years with a history of type @ diabetes among their first-degree relatives were recruited . li group received three times of lifestyle intervention using liss-dp during six-month intervention period via mail . lifestyle intervention group showed significantly greater decrease in energy intake six months after baseline , compared to control ( -@ and -@ kcal/day , respectively , p = @ , cohen 's d = @ ) , though the difference disappeared @ year after from baseline . no difference was found in physical activity energy expenditure . a computer-based , non-face-to-face lifestyle intervention was effective on dietary habits , only during the intervention period . further examination of the long-term effects of such intervention and physical activity is required .
24,529,485
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the present study aimed to compare the postoperative contrast sensitivity functions between wavefront-guided lasik eyes and their contralateral wavefront-guided prk eyes .", "the participants were @ healthy subjects ( mean age = @ @ years ) who had myopic astigmatism .", "the spatial contrast sensitivity functions were measured before and three times after the surgery .", "psycho and a cambridge graphic board ( vsg @/@ ) were used to measure luminance , red-green , and blue-yellow spatial contrast sensitivity functions ( from @ to @ cycles/degree ) .", "longitudinal analysis and comparison between surgeries were performed .", "there was no significant contrast sensitivity change during the one-year follow-up measurements neither for lasik nor for prk eyes .", "the comparison between procedures showed no differences at @ months postoperative .", "the present data showed similar contrast sensitivities during one-year follow-up of wave-front guided refractive surgeries .", "moreover , one year postoperative data showed no differences in the effects of either wavefront-guided lasik or wavefront-guided prk on the luminance and chromatic spatial contrast sensitivity functions ." ]
the present study aimed to compare the postoperative contrast sensitivity functions between wavefront-guided lasik eyes and their contralateral wavefront-guided prk eyes . the participants were @ healthy subjects ( mean age = @ @ years ) who had myopic astigmatism . the spatial contrast sensitivity functions were measured before and three times after the surgery . psycho and a cambridge graphic board ( vsg @/@ ) were used to measure luminance , red-green , and blue-yellow spatial contrast sensitivity functions ( from @ to @ cycles/degree ) . longitudinal analysis and comparison between surgeries were performed . there was no significant contrast sensitivity change during the one-year follow-up measurements neither for lasik nor for prk eyes . the comparison between procedures showed no differences at @ months postoperative . the present data showed similar contrast sensitivities during one-year follow-up of wave-front guided refractive surgeries . moreover , one year postoperative data showed no differences in the effects of either wavefront-guided lasik or wavefront-guided prk on the luminance and chromatic spatial contrast sensitivity functions .
24,232,938
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "survivors of cervical cancer experience quality-of-life ( qol ) disruptions that persist years after treatment .", "this study examines the effect of a psychosocial telephone counseling ( ptc ) intervention on qol domains and associations with biomarkers .", "we conducted a randomized clinical trial in survivors of cervical cancer , who were @ and less than @ months from diagnosis ( n = @ ) , to compare ptc to usual care ( uc ) .", "ptc included five weekly sessions and a @-month booster .", "patient-reported outcomes ( pros ) and biospecimens were collected at baseline and @ and @ months after enrollment .", "changes in pros over time and associations with longitudinal change in cytokines as categorical variables were analyzed using multivariable analysis of variance for repeated measures .", "participant mean age was @ years ; @ % of women were hispanic , and @ % were non-hispanic white .", "adjusting for age and baseline scores , participants receiving ptc had significantly improved depression and improved gynecologic and cancer-specific concerns at @ months compared with uc participants ( all p < @ ) ; significant differences in gynecologic and cancer-specific concerns ( p < @ ) were sustained at @ months .", "longitudinal change in overall qol and anxiety did not reach statistical significance .", "participants with decreasing interleukin ( il ) -@ , il-@ , il-@ , and il-@ had significantly greater improvement in qol than those with increasing cytokine levels .", "this trial confirms that ptc benefits mood and qol cancer-specific and gynecologic concerns for a multiethnic underserved population of survivors of cancer .", "the improvement in pros with decreases in t-helper type @ and counter-regulatory cytokines supports a potential biobehavioral pathway relevant to cancer survivorship ." ]
survivors of cervical cancer experience quality-of-life ( qol ) disruptions that persist years after treatment . this study examines the effect of a psychosocial telephone counseling ( ptc ) intervention on qol domains and associations with biomarkers . we conducted a randomized clinical trial in survivors of cervical cancer , who were @ and less than @ months from diagnosis ( n = @ ) , to compare ptc to usual care ( uc ) . ptc included five weekly sessions and a @-month booster . patient-reported outcomes ( pros ) and biospecimens were collected at baseline and @ and @ months after enrollment . changes in pros over time and associations with longitudinal change in cytokines as categorical variables were analyzed using multivariable analysis of variance for repeated measures . participant mean age was @ years ; @ % of women were hispanic , and @ % were non-hispanic white . adjusting for age and baseline scores , participants receiving ptc had significantly improved depression and improved gynecologic and cancer-specific concerns at @ months compared with uc participants ( all p < @ ) ; significant differences in gynecologic and cancer-specific concerns ( p < @ ) were sustained at @ months . longitudinal change in overall qol and anxiety did not reach statistical significance . participants with decreasing interleukin ( il ) -@ , il-@ , il-@ , and il-@ had significantly greater improvement in qol than those with increasing cytokine levels . this trial confirms that ptc benefits mood and qol cancer-specific and gynecologic concerns for a multiethnic underserved population of survivors of cancer . the improvement in pros with decreases in t-helper type @ and counter-regulatory cytokines supports a potential biobehavioral pathway relevant to cancer survivorship .
25,713,429
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "there is a paucity of data on the effect of antiretroviral medications on male fertility .", "couples affected by hiv-@ often have fertility intentions , and antiretroviral medications , as both treatment of hiv-@-infected persons and pre-exposure prophylaxis ( prep ) for uninfected persons , are part of peri-conception risk reduction .", "within a randomized , placebo-controlled trial of daily oral tenofovir disoproxil fumarate ( tdf ) and combination emtricitabine ( ftc ) / tdf prep for hiv-@ prevention conducted among heterosexual hiv-@-serodiscordant couples , we assessed the impact of tdf and ftc/tdf use on male fertility , measured as incident pregnancy in female partners of men assigned to prep vs. placebo .", "of the @ hiv-@-uninfected men partners , @ were randomized to tdf , @ to ftc/tdf , and @ to placebo .", "the overall pregnancy incidence in their hiv-@-infected female partners was @ per @ person-years and did not differ significantly across the study arms ( @ tdf , @ ftc/tdf , @ placebo ) .", "the frequency of live births , pregnancy losses , and gestational age at birth or loss was also statistically similar in the three randomization groups .", "tdf and ftc/tdf , when used as prep by hiv-@-uninfected men , did not adversely affect male fertility or pregnancy outcomes ." ]
there is a paucity of data on the effect of antiretroviral medications on male fertility . couples affected by hiv-@ often have fertility intentions , and antiretroviral medications , as both treatment of hiv-@-infected persons and pre-exposure prophylaxis ( prep ) for uninfected persons , are part of peri-conception risk reduction . within a randomized , placebo-controlled trial of daily oral tenofovir disoproxil fumarate ( tdf ) and combination emtricitabine ( ftc ) / tdf prep for hiv-@ prevention conducted among heterosexual hiv-@-serodiscordant couples , we assessed the impact of tdf and ftc/tdf use on male fertility , measured as incident pregnancy in female partners of men assigned to prep vs. placebo . of the @ hiv-@-uninfected men partners , @ were randomized to tdf , @ to ftc/tdf , and @ to placebo . the overall pregnancy incidence in their hiv-@-infected female partners was @ per @ person-years and did not differ significantly across the study arms ( @ tdf , @ ftc/tdf , @ placebo ) . the frequency of live births , pregnancy losses , and gestational age at birth or loss was also statistically similar in the three randomization groups . tdf and ftc/tdf , when used as prep by hiv-@-uninfected men , did not adversely affect male fertility or pregnancy outcomes .
25,259,704
[ "BACKGROUND", "BACKGROUND", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "tiotropium is a once-daily , long-acting anticholinergic bronchodilator with the potential to alleviate airway obstruction in cystic fibrosis .", "our objective was to evaluate the efficacy and safety of @ and @ g once-daily tiotropium delivered via the respimat soft mist inhaler vs. placebo in people with cystic fibrosis .", "this phase @ , @-week , randomized , double-blind , placebo-controlled parallel-group study of tiotropium respimat as add-on to usual cystic fibrosis maintenance therapy included people with cystic fibrosis with pre-bronchodilator forced expiratory volume in @ second ( fev@ ) @ % predicted .", "co-primary efficacy end points were change from baseline in percent-predicted fev@ area under the curve from @ to @ hours ( fev@ auc@-@h ) , and trough fev@ at the end of week @ .", "a total of @ subjects with cystic fibrosis aged @-@ years were randomized .", "both doses of tiotropium resulted in significant improvement compared with placebo in the co-primary efficacy end points at the end of week @ ( change from baseline in percent-predicted fev@ auc@-@h : @ g : @ % , @ % confidence interval @-@ @ , p = @ ; @ g : @ % , @ % confidence interval @-@ @ , p = @ ; in percent-predicted trough fev@ @ g : @ % , p = @ ; @ g : @ % , p = @ ) .", "there was a greater benefit with tiotropium @ vs. @ g. no treatment-related adverse events or unexpected safety findings were observed in patients taking tiotropium .", "tiotropium significantly improved lung function in people with cystic fibrosis .", "the improvement was greater with the higher dose than the lower dose , with no difference in adverse events .", "clinicaltrials.gov nct@ eudract @-@-@ ." ]
tiotropium is a once-daily , long-acting anticholinergic bronchodilator with the potential to alleviate airway obstruction in cystic fibrosis . our objective was to evaluate the efficacy and safety of @ and @ g once-daily tiotropium delivered via the respimat soft mist inhaler vs. placebo in people with cystic fibrosis . this phase @ , @-week , randomized , double-blind , placebo-controlled parallel-group study of tiotropium respimat as add-on to usual cystic fibrosis maintenance therapy included people with cystic fibrosis with pre-bronchodilator forced expiratory volume in @ second ( fev@ ) @ % predicted . co-primary efficacy end points were change from baseline in percent-predicted fev@ area under the curve from @ to @ hours ( fev@ auc@-@h ) , and trough fev@ at the end of week @ . a total of @ subjects with cystic fibrosis aged @-@ years were randomized . both doses of tiotropium resulted in significant improvement compared with placebo in the co-primary efficacy end points at the end of week @ ( change from baseline in percent-predicted fev@ auc@-@h : @ g : @ % , @ % confidence interval @-@ @ , p = @ ; @ g : @ % , @ % confidence interval @-@ @ , p = @ ; in percent-predicted trough fev@ @ g : @ % , p = @ ; @ g : @ % , p = @ ) . there was a greater benefit with tiotropium @ vs. @ g. no treatment-related adverse events or unexpected safety findings were observed in patients taking tiotropium . tiotropium significantly improved lung function in people with cystic fibrosis . the improvement was greater with the higher dose than the lower dose , with no difference in adverse events . clinicaltrials.gov nct@ eudract @-@-@ .
25,188,297
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "obstructive sleep apnea is associated with hypertension , inflammation , and increased cardiovascular risk .", "continuous positive airway pressure ( cpap ) reduces blood pressure , but adherence is often suboptimal , and the benefit beyond management of conventional risk factors is uncertain .", "since intermittent hypoxemia may underlie cardiovascular sequelae of sleep apnea , we evaluated the effects of nocturnal supplemental oxygen and cpap on markers of cardiovascular risk .", "we conducted a randomized , controlled trial in which patients with cardiovascular disease or multiple cardiovascular risk factors were recruited from cardiology practices .", "patients were screened for obstructive sleep apnea with the use of the berlin questionnaire , and home sleep testing was used to establish the diagnosis .", "participants with an apnea-hypopnea index of @ to @ events per hour were randomly assigned to receive education on sleep hygiene and healthy lifestyle alone ( the control group ) or , in addition to education , either cpap or nocturnal supplemental oxygen .", "cardiovascular risk was assessed at baseline and after @ weeks of the study treatment .", "the primary outcome was @-hour mean arterial pressure .", "of @ patients who underwent randomization , @ ( @ % ) could be evaluated for ambulatory blood pressure at both baseline and follow-up .", "on average , the @-hour mean arterial pressure at @ weeks was lower in the group receiving cpap than in the control group ( -@ mm hg ; @ % confidence interval -lsb- ci -rsb- , -@ to -@ ; p = @ ) or the group receiving supplemental oxygen ( -@ mm hg ; @ % ci , -@ to -@ ; p = @ ) .", "there was no significant difference in the @-hour mean arterial pressure between the control group and the group receiving oxygen .", "a sensitivity analysis performed with the use of multiple imputation approaches to assess the effect of missing data did not change the results of the primary analysis .", "in patients with cardiovascular disease or multiple cardiovascular risk factors , the treatment of obstructive sleep apnea with cpap , but not nocturnal supplemental oxygen , resulted in a significant reduction in blood pressure .", "( funded by the national heart , lung , and blood institute and others ; heartbeat clinicaltrials.gov number , nct@ . )" ]
obstructive sleep apnea is associated with hypertension , inflammation , and increased cardiovascular risk . continuous positive airway pressure ( cpap ) reduces blood pressure , but adherence is often suboptimal , and the benefit beyond management of conventional risk factors is uncertain . since intermittent hypoxemia may underlie cardiovascular sequelae of sleep apnea , we evaluated the effects of nocturnal supplemental oxygen and cpap on markers of cardiovascular risk . we conducted a randomized , controlled trial in which patients with cardiovascular disease or multiple cardiovascular risk factors were recruited from cardiology practices . patients were screened for obstructive sleep apnea with the use of the berlin questionnaire , and home sleep testing was used to establish the diagnosis . participants with an apnea-hypopnea index of @ to @ events per hour were randomly assigned to receive education on sleep hygiene and healthy lifestyle alone ( the control group ) or , in addition to education , either cpap or nocturnal supplemental oxygen . cardiovascular risk was assessed at baseline and after @ weeks of the study treatment . the primary outcome was @-hour mean arterial pressure . of @ patients who underwent randomization , @ ( @ % ) could be evaluated for ambulatory blood pressure at both baseline and follow-up . on average , the @-hour mean arterial pressure at @ weeks was lower in the group receiving cpap than in the control group ( -@ mm hg ; @ % confidence interval -lsb- ci -rsb- , -@ to -@ ; p = @ ) or the group receiving supplemental oxygen ( -@ mm hg ; @ % ci , -@ to -@ ; p = @ ) . there was no significant difference in the @-hour mean arterial pressure between the control group and the group receiving oxygen . a sensitivity analysis performed with the use of multiple imputation approaches to assess the effect of missing data did not change the results of the primary analysis . in patients with cardiovascular disease or multiple cardiovascular risk factors , the treatment of obstructive sleep apnea with cpap , but not nocturnal supplemental oxygen , resulted in a significant reduction in blood pressure . ( funded by the national heart , lung , and blood institute and others ; heartbeat clinicaltrials.gov number , nct@ . )
24,918,372
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "oxidative stress and inflammation during cardiac surgery may be associated with acute renal injury ( ari ) .", "n-acetyl cysteine ( nac ) and carvedilol have antioxidant and anti-inflammatory properties .", "a combination of carvedilol and nac should decrease the incidence of ari more than metoprolol or carvedilol .", "patients undergoing cardiac surgery were randomized to metoprolol , carvedilol , or carvedilol plus nac .", "end points were occurrence of ari and change in preoperative to postoperative peak creatinine levels .", "ari incidence was lower in the carvedilol plus nac group compared with the metoprolol ( @ % vs @ % ; p = @ ) or carvedilol ( @ % vs @ % ; p = @ ) groups , but was similar between the metoprolol and carvedilol groups ( p = @ ) .", "preoperative and postoperative day @ creatinine levels were similar among the metoprolol ( @ -lsb- @-@ @ -rsb- and @ -lsb- @-@ @ -rsb- ) the carvedilol ( @ -lsb- @-@ @ -rsb- and @ -lsb- @-@ @ -rsb- ) and the carvedilol plus nac groups ( @ -lsb- @-@ @ -rsb- and @ -lsb- @-@ @ -rsb- mg/dl ; all p values > @ ) .", "postoperative day @ , day @ , and peak creatinine levels were lower in the carvedilol plus nac group ( @ -lsb- @-@ @ -rsb- , @ -lsb- @-@ @ -rsb- and @ -lsb- @-@ @ -rsb- ) as compared with the metoprolol ( @ -lsb- @-@ @ -rsb- , @ -lsb- @-@ @ -rsb- and @ -lsb- @-@ @ -rsb- ) or carvedilol groups ( @ -lsb- @-@ @ -rsb- , @ -lsb- @-@ @ -rsb- and @ -lsb- @-@ @ -rsb- mg/dl ; all p values < @ ) , but were similar between the metoprolol and carvedilol groups ( all p values > @ ) .", "combined carvedilol and nac decreased ari incidence as compared with carvedilol or metoprolol .", "no difference was detected between carvedilol and metoprolol ." ]
oxidative stress and inflammation during cardiac surgery may be associated with acute renal injury ( ari ) . n-acetyl cysteine ( nac ) and carvedilol have antioxidant and anti-inflammatory properties . a combination of carvedilol and nac should decrease the incidence of ari more than metoprolol or carvedilol . patients undergoing cardiac surgery were randomized to metoprolol , carvedilol , or carvedilol plus nac . end points were occurrence of ari and change in preoperative to postoperative peak creatinine levels . ari incidence was lower in the carvedilol plus nac group compared with the metoprolol ( @ % vs @ % ; p = @ ) or carvedilol ( @ % vs @ % ; p = @ ) groups , but was similar between the metoprolol and carvedilol groups ( p = @ ) . preoperative and postoperative day @ creatinine levels were similar among the metoprolol ( @ -lsb- @-@ @ -rsb- and @ -lsb- @-@ @ -rsb- ) the carvedilol ( @ -lsb- @-@ @ -rsb- and @ -lsb- @-@ @ -rsb- ) and the carvedilol plus nac groups ( @ -lsb- @-@ @ -rsb- and @ -lsb- @-@ @ -rsb- mg/dl ; all p values > @ ) . postoperative day @ , day @ , and peak creatinine levels were lower in the carvedilol plus nac group ( @ -lsb- @-@ @ -rsb- , @ -lsb- @-@ @ -rsb- and @ -lsb- @-@ @ -rsb- ) as compared with the metoprolol ( @ -lsb- @-@ @ -rsb- , @ -lsb- @-@ @ -rsb- and @ -lsb- @-@ @ -rsb- ) or carvedilol groups ( @ -lsb- @-@ @ -rsb- , @ -lsb- @-@ @ -rsb- and @ -lsb- @-@ @ -rsb- mg/dl ; all p values < @ ) , but were similar between the metoprolol and carvedilol groups ( all p values > @ ) . combined carvedilol and nac decreased ari incidence as compared with carvedilol or metoprolol . no difference was detected between carvedilol and metoprolol .
24,672,814
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "ticagrelor has been shown to improve outcomes in patients with acs .", "however , the effects of this drug on parameters of microvascular flow in patients presenting with st-segment elevation myocardial infarction ( stemi ) have not been completely evaluated .", "ninety-two patients presenting with stemi where randomized to a loading dose of clopidogrel ( @ mg ) or ticagrelor ( @ mg ) before undergoing primary angioplasty .", "we assessed angiographic and electrocardiographic parameters of myocardial reperfusion .", "blinded operators calculated angiographic corrected timi frame count ( ctfc ) and myocardial blush grade ( mbg ) before and after stent implantation .", "st segment resolution was also measured in all patients .", "primary endpoint was ctfc after pci .", "secondary endpoints were ctfc prior to pci , timi flow grade , mbg and the percentage of st resolution .", "of the @ randomized patients , @ patients were analyzed .", "mean age of patients was @ years .", "patients presented with a mean ischemic time of @ hours .", "there were no significant differences in the time between loading dose and stent deployment ( @ in ticagrelor and @ min in clopidogrel , p = @ ) .", "ctfc before angioplasty was significantly lower in ticagrelor than in clopidogrel ( @ vs. @ frames respectively , p = @ ) .", "after angioplasty there were no differences between ticagrelor and clopidogrel in ctfc ( @ vs. @ frames respectively , p = @ ) ; mbg grade @ was present in @ vs. @ % of patients , respectively ( p = @ ) .", "the percentage of st resolution did not show any differences between groups ( @ in ticagrelor vs. @ in clopidogrel , p = @ ) .", "compared with clopidogrel , ticagrelor loading in patients presenting with stemi is not associated with an improvement of angiographic and electrocardiographic parameters of myocardial reperfusion after angioplasty ." ]
ticagrelor has been shown to improve outcomes in patients with acs . however , the effects of this drug on parameters of microvascular flow in patients presenting with st-segment elevation myocardial infarction ( stemi ) have not been completely evaluated . ninety-two patients presenting with stemi where randomized to a loading dose of clopidogrel ( @ mg ) or ticagrelor ( @ mg ) before undergoing primary angioplasty . we assessed angiographic and electrocardiographic parameters of myocardial reperfusion . blinded operators calculated angiographic corrected timi frame count ( ctfc ) and myocardial blush grade ( mbg ) before and after stent implantation . st segment resolution was also measured in all patients . primary endpoint was ctfc after pci . secondary endpoints were ctfc prior to pci , timi flow grade , mbg and the percentage of st resolution . of the @ randomized patients , @ patients were analyzed . mean age of patients was @ years . patients presented with a mean ischemic time of @ hours . there were no significant differences in the time between loading dose and stent deployment ( @ in ticagrelor and @ min in clopidogrel , p = @ ) . ctfc before angioplasty was significantly lower in ticagrelor than in clopidogrel ( @ vs. @ frames respectively , p = @ ) . after angioplasty there were no differences between ticagrelor and clopidogrel in ctfc ( @ vs. @ frames respectively , p = @ ) ; mbg grade @ was present in @ vs. @ % of patients , respectively ( p = @ ) . the percentage of st resolution did not show any differences between groups ( @ in ticagrelor vs. @ in clopidogrel , p = @ ) . compared with clopidogrel , ticagrelor loading in patients presenting with stemi is not associated with an improvement of angiographic and electrocardiographic parameters of myocardial reperfusion after angioplasty .
25,178,668
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "povidone iodine is used primarily as an antiseptic to decrease surgical site infection .", "its hemostatic and antiedematous properties in oral surgery also have been investigated recently .", "a randomized controlled clinical trial was performed in @ patients undergoing mandibular third molar removal in a split-mouth design .", "in the study group , a povidone iodine solution with a concentration of @ mg/ml was used as the coolant and irrigant solution , whereas normal saline was used in the control group .", "swelling ( orotragus and mentotragus distances ) , trismus ( maximum interincisal opening ) , and pain ( visual analog scale score ) were evaluated on postoperative days @ and @ .", "in the study group , a significant decrease in swelling and trismus was observed at the @ postoperative visits ( p = @ ) compared with the control group .", "the decrease of pain in the study group was not statistically significant at either postoperative visit ( p > @ ) .", "more patients ( @ % ) were subjectively satisfied with the side treated with povidone iodine .", "povidone iodine irrigation is an inexpensive and safe method to lessen the postoperative sequelae of third molar surgery ." ]
povidone iodine is used primarily as an antiseptic to decrease surgical site infection . its hemostatic and antiedematous properties in oral surgery also have been investigated recently . a randomized controlled clinical trial was performed in @ patients undergoing mandibular third molar removal in a split-mouth design . in the study group , a povidone iodine solution with a concentration of @ mg/ml was used as the coolant and irrigant solution , whereas normal saline was used in the control group . swelling ( orotragus and mentotragus distances ) , trismus ( maximum interincisal opening ) , and pain ( visual analog scale score ) were evaluated on postoperative days @ and @ . in the study group , a significant decrease in swelling and trismus was observed at the @ postoperative visits ( p = @ ) compared with the control group . the decrease of pain in the study group was not statistically significant at either postoperative visit ( p > @ ) . more patients ( @ % ) were subjectively satisfied with the side treated with povidone iodine . povidone iodine irrigation is an inexpensive and safe method to lessen the postoperative sequelae of third molar surgery .
25,249,172
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "pertuzumab plus trastuzumab provides a more comprehensive blockade of her@ signalling than trastuzumab alone .", "therefore , we conducted a phase iia study of the pharmacokinetics and safety of pertuzumab plus trastuzumab and chemotherapy in advanced gastric cancer ( agc ) .", "patients received pertuzumab @ mg for cycle @ and @ mg q@w for cycles @-@ ( arm a ) or pertuzumab @ mg q@w for six cycles ( arm b ) .", "trastuzumab , cisplatin and capecitabine were also given for six cycles , then trastuzumab q@w until disease progression or unmanageable toxicity .", "the co-primary endpoints were day @ pertuzumab serum trough concentration ( cmin ) and safety .", "thirty patients were randomised .", "mean pertuzumab cmin at day @ was @ g ml ( -@ ) ( s.d. : @ ) in arm a and @ g ml ( -@ ) ( @ ) in arm b. mean day @ cmin in arm a was ~ @ % lower than that seen in metastatic breast cancer .", "the safety profiles were similar between arms and treatment was well tolerated .", "partial responses were achieved by @ % and @ % of patients in arms a and b , respectively .", "on the basis of the pharmacokinetic and safety data , the @ mg q@w pertuzumab dose has been selected for a phase iii study of pertuzumab , trastuzumab and chemotherapy in her@-positive agc ." ]
pertuzumab plus trastuzumab provides a more comprehensive blockade of her@ signalling than trastuzumab alone . therefore , we conducted a phase iia study of the pharmacokinetics and safety of pertuzumab plus trastuzumab and chemotherapy in advanced gastric cancer ( agc ) . patients received pertuzumab @ mg for cycle @ and @ mg q@w for cycles @-@ ( arm a ) or pertuzumab @ mg q@w for six cycles ( arm b ) . trastuzumab , cisplatin and capecitabine were also given for six cycles , then trastuzumab q@w until disease progression or unmanageable toxicity . the co-primary endpoints were day @ pertuzumab serum trough concentration ( cmin ) and safety . thirty patients were randomised . mean pertuzumab cmin at day @ was @ g ml ( -@ ) ( s.d. : @ ) in arm a and @ g ml ( -@ ) ( @ ) in arm b. mean day @ cmin in arm a was ~ @ % lower than that seen in metastatic breast cancer . the safety profiles were similar between arms and treatment was well tolerated . partial responses were achieved by @ % and @ % of patients in arms a and b , respectively . on the basis of the pharmacokinetic and safety data , the @ mg q@w pertuzumab dose has been selected for a phase iii study of pertuzumab , trastuzumab and chemotherapy in her@-positive agc .
24,960,402
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "there are significant health disparities between mori and non-mori with asthma , a pattern seen between other ethnic populations .", "this study investigates outcomes for mori in a randomized controlled trial ( rct ) of combination budesonide/formoterol inhaler therapy in asthma .", "this @-week multicentre rct recruited @ adult asthma patients , @ of whom were mori .", "participants were randomized to the single combination budesonide/formoterol inhaler as maintenance and reliever therapy ( ` smart ' ) regimen or ` standard ' regimen ( combination budesonide/formoterol inhaler for maintenance and salbutamol as reliever ) .", "outcomes included patterns of beta-agonist inhaler use including ` high use ' of reliever therapy ( > @ actuations of budesonide/formoterol in excess of four maintenance doses per day for smart and > @ actuations per day of salbutamol for standard ) .", "differences in outcomes for mori versus non-mori were assessed using an interaction term between ethnicity and treatment .", "with adjustment for ethnicity , the smart group had fewer days of high use ( relative rate ( rr ) @ ( @ % confidence interval ( ci ) : @-@ @ ) ) , days of high use without medical review within @ h ( rr @ ( @ % ci : @-@ @ ) ) and severe exacerbations ( rr @ ( @ % ci : @-@ @ ) ) compared with standard .", "the magnitude of the benefit from the smart regimen was similar in mori and non-mori .", "regardless of treatment regimen , mori demonstrated more days of high use , high use without medical review and underuse of maintenance therapy .", "the smart regimen has a favourable risk/benefit profile in mori .", "days of high use , days of high use without medical review and underuse of maintenance treatment were greater in mori , regardless of treatment regimen ." ]
there are significant health disparities between mori and non-mori with asthma , a pattern seen between other ethnic populations . this study investigates outcomes for mori in a randomized controlled trial ( rct ) of combination budesonide/formoterol inhaler therapy in asthma . this @-week multicentre rct recruited @ adult asthma patients , @ of whom were mori . participants were randomized to the single combination budesonide/formoterol inhaler as maintenance and reliever therapy ( ` smart ' ) regimen or ` standard ' regimen ( combination budesonide/formoterol inhaler for maintenance and salbutamol as reliever ) . outcomes included patterns of beta-agonist inhaler use including ` high use ' of reliever therapy ( > @ actuations of budesonide/formoterol in excess of four maintenance doses per day for smart and > @ actuations per day of salbutamol for standard ) . differences in outcomes for mori versus non-mori were assessed using an interaction term between ethnicity and treatment . with adjustment for ethnicity , the smart group had fewer days of high use ( relative rate ( rr ) @ ( @ % confidence interval ( ci ) : @-@ @ ) ) , days of high use without medical review within @ h ( rr @ ( @ % ci : @-@ @ ) ) and severe exacerbations ( rr @ ( @ % ci : @-@ @ ) ) compared with standard . the magnitude of the benefit from the smart regimen was similar in mori and non-mori . regardless of treatment regimen , mori demonstrated more days of high use , high use without medical review and underuse of maintenance therapy . the smart regimen has a favourable risk/benefit profile in mori . days of high use , days of high use without medical review and underuse of maintenance treatment were greater in mori , regardless of treatment regimen .
24,889,937
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "early infant male circumcision ( eimc ) is a potential key hiv prevention intervention , providing it can be safely and efficiently implemented in sub-saharan africa .", "here , we present results of a randomized noninferiority trial of eimc comparing the accucirc device with mogen clamp in zimbabwe .", "between january and june @ , eligible infants were randomized to eimc through either accucirc or mogen clamp conducted by a doctor , using a @:@ allocation ratio .", "participants were followed for @ days post-eimc .", "primary outcomes for the trial were eimc safety and acceptability .", "one hundred fifty male infants were enrolled in the trial and circumcised between @ and @ days postpartum ( n = @ accucirc ; n = @ mogen clamp ) .", "twenty-six infants ( @ % ) were born to hiv-infected mothers .", "we observed @ moderate adverse events ( aes ) -lsb- @ % , @ % confidence interval ( ci ) : @ to @ -rsb- in the accucirc arm and none ( @ % ci : @ to @ ) in the mogen clamp arm .", "the cumulative incident risk of aes was @ % higher in the accucirc arm compared with the mogen clamp arm ( @ % ci : -@ to @ ) .", "as the @ % ci excludes the predefined noninferiority margin of @ % , the result provides evidence of noninferiority of accucirc compared with the mogen clamp .", "nearly all mothers ( @ % ) reported great satisfaction with the outcome .", "all mothers , regardless of arm said they would recommend eimc to other parents , and would circumcise their next son .", "this first randomized trial of accucirc versus mogen clamp for eimc demonstrated that eimc using these devices is safe and acceptable to parents .", "there was no difference in the rate of aes by device ." ]
early infant male circumcision ( eimc ) is a potential key hiv prevention intervention , providing it can be safely and efficiently implemented in sub-saharan africa . here , we present results of a randomized noninferiority trial of eimc comparing the accucirc device with mogen clamp in zimbabwe . between january and june @ , eligible infants were randomized to eimc through either accucirc or mogen clamp conducted by a doctor , using a @:@ allocation ratio . participants were followed for @ days post-eimc . primary outcomes for the trial were eimc safety and acceptability . one hundred fifty male infants were enrolled in the trial and circumcised between @ and @ days postpartum ( n = @ accucirc ; n = @ mogen clamp ) . twenty-six infants ( @ % ) were born to hiv-infected mothers . we observed @ moderate adverse events ( aes ) -lsb- @ % , @ % confidence interval ( ci ) : @ to @ -rsb- in the accucirc arm and none ( @ % ci : @ to @ ) in the mogen clamp arm . the cumulative incident risk of aes was @ % higher in the accucirc arm compared with the mogen clamp arm ( @ % ci : -@ to @ ) . as the @ % ci excludes the predefined noninferiority margin of @ % , the result provides evidence of noninferiority of accucirc compared with the mogen clamp . nearly all mothers ( @ % ) reported great satisfaction with the outcome . all mothers , regardless of arm said they would recommend eimc to other parents , and would circumcise their next son . this first randomized trial of accucirc versus mogen clamp for eimc demonstrated that eimc using these devices is safe and acceptable to parents . there was no difference in the rate of aes by device .
26,010,029
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "this randomized , cross-over trial was designed to investigate the metabolic and appetitive responses to skipping breakfast in overweight women who were habitual breakfast eaters or skippers .", "nine eaters and nine skippers were studied on two separate days during which subjects ate breakfast ( b ) or had no breakfast ( nb ) , followed by a standard lunch meal @ h later .", "blood sampling for hormones and metabolites was performed after lunch , and appetite was rated throughout the day .", "interactions between day and habitual breakfast pattern were seen for area under the curve ( auc ) for insulin and free fatty acids ( ffa ) .", "both insulin ( p = @ ) and ffa ( p = @ ) auc were higher on the nb day for eaters but similar on both days for skippers .", "eaters had higher pre lunch hunger auc on the nb day ( p = @ ) as well as lower pre lunch satiety auc under both conditions ( p = @ ) .", "overall , this study showed that the adverse effects of skipping breakfast ( higher insulin and ffa responses to lunch , increased hunger , and decreased satiety ) were found primarily in habitual breakfast eaters .", "this suggests that meal skipping may have enhanced effects in habitual eaters due to entrainment of metabolic and appetitive regulatory systems ." ]
this randomized , cross-over trial was designed to investigate the metabolic and appetitive responses to skipping breakfast in overweight women who were habitual breakfast eaters or skippers . nine eaters and nine skippers were studied on two separate days during which subjects ate breakfast ( b ) or had no breakfast ( nb ) , followed by a standard lunch meal @ h later . blood sampling for hormones and metabolites was performed after lunch , and appetite was rated throughout the day . interactions between day and habitual breakfast pattern were seen for area under the curve ( auc ) for insulin and free fatty acids ( ffa ) . both insulin ( p = @ ) and ffa ( p = @ ) auc were higher on the nb day for eaters but similar on both days for skippers . eaters had higher pre lunch hunger auc on the nb day ( p = @ ) as well as lower pre lunch satiety auc under both conditions ( p = @ ) . overall , this study showed that the adverse effects of skipping breakfast ( higher insulin and ffa responses to lunch , increased hunger , and decreased satiety ) were found primarily in habitual breakfast eaters . this suggests that meal skipping may have enhanced effects in habitual eaters due to entrainment of metabolic and appetitive regulatory systems .
25,755,093
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the aim of this study was to compare the combined ultrasound-guided supraclavicular brachial plexus block ( scb ) and distal median , radial , and ulnar nerve blocks , with the supraclavicular block alone .", "sixty-two patients undergoing upper extremity surgery were randomized to supraclavicular only ( group s , n = @ ) or supraclavicular + distal ( group sd , n = @ ) group .", "patients in group s received @ml of @ % lidocaine + epinephrine @g/ml , while those in group sd received @ml of @ % lidocaine + epinephrine @g/ml followed by distal median , radial , and ulnar nerve blocks using equal volumes of @ % lidocaine +@ % levobupivacaine ( @ml/nerve ) .", "sensory and motor blocks of the ulnar , median , radial and musculocutaneous nerves were assessed every @min starting at the @th minute .", "the imaging , needling and performance times were recorded .", "also , the onset and anesthesia-related times , need for analgesic and first analgesic times , were noted .", "in group sd , the anesthesia onset -lsb- @ ( @-@ ) vs. @ ( @-@ ) min , p < @ -rsb- and anesthesia related times -lsb- @ ( @-@ @ ) vs. @ ( @-@ @ ) min , p < @ -rsb- were significantly shorter than those of group s. additionally , the analgesic requirement was lower in group sd ( @ vs. @ % , p = @ ) , while among the patients who required analgesic , the first analgesic time was longer in group sd in comparison to group s -lsb- @ ( @-@ ) vs. @ ( @-@ ) min p < @ -rsb- .", "the addition of distal median , radial , and ulnar nerve blocks to scb shortens anesthesia-related time and anesthesia onset time when compared with a scb alone ." ]
the aim of this study was to compare the combined ultrasound-guided supraclavicular brachial plexus block ( scb ) and distal median , radial , and ulnar nerve blocks , with the supraclavicular block alone . sixty-two patients undergoing upper extremity surgery were randomized to supraclavicular only ( group s , n = @ ) or supraclavicular + distal ( group sd , n = @ ) group . patients in group s received @ml of @ % lidocaine + epinephrine @g/ml , while those in group sd received @ml of @ % lidocaine + epinephrine @g/ml followed by distal median , radial , and ulnar nerve blocks using equal volumes of @ % lidocaine +@ % levobupivacaine ( @ml/nerve ) . sensory and motor blocks of the ulnar , median , radial and musculocutaneous nerves were assessed every @min starting at the @th minute . the imaging , needling and performance times were recorded . also , the onset and anesthesia-related times , need for analgesic and first analgesic times , were noted . in group sd , the anesthesia onset -lsb- @ ( @-@ ) vs. @ ( @-@ ) min , p < @ -rsb- and anesthesia related times -lsb- @ ( @-@ @ ) vs. @ ( @-@ @ ) min , p < @ -rsb- were significantly shorter than those of group s. additionally , the analgesic requirement was lower in group sd ( @ vs. @ % , p = @ ) , while among the patients who required analgesic , the first analgesic time was longer in group sd in comparison to group s -lsb- @ ( @-@ ) vs. @ ( @-@ ) min p < @ -rsb- . the addition of distal median , radial , and ulnar nerve blocks to scb shortens anesthesia-related time and anesthesia onset time when compared with a scb alone .
25,097,089
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS" ]
[ "patients suffering from mild-to-moderate medial compartment knee osteoarthritis may be treated with an unloader knee orthosis .", "however , compliance has been shown to be an issue with such devices .", "the aim of this study was to identify the effects of a new design of knee unloader orthosis on specific gait parameters in patients with mild-to-moderate medial knee osteoarthritis .", "the gait of seven patients was assessed in two conditions : without an orthosis and when wearing a new design of unloader knee orthosis .", "gait analysis was performed to determine alterations to the adduction moment , speed of walking , step length , cadence and knee sagittal plane range of motion during ambulation for the two test conditions .", "the knee adduction moment was significantly reduced ( p = @ ) , and the speed of walking significantly increased ( p < @ ) when wearing the orthosis .", "however , a reduction in knee range of motion ( p = @ ) and an increase in step length ( p < @ ) were observed with the orthosis donned .", "cadence was not significantly altered ( p = @ ) .", "the use of a new design of unloader knee orthosis as a conservative treatment approach for patients with mild-to-moderate medial compartment osteoarthritis appears warranted .", "various conservative modalities have been used to reduce pain and improve function in medial compartment osteoarthritis .", "a new design of an unloader knee orthosis has been developed and is shown to have immediate benefits in patients with mild medial knee osteoarthritis ." ]
patients suffering from mild-to-moderate medial compartment knee osteoarthritis may be treated with an unloader knee orthosis . however , compliance has been shown to be an issue with such devices . the aim of this study was to identify the effects of a new design of knee unloader orthosis on specific gait parameters in patients with mild-to-moderate medial knee osteoarthritis . the gait of seven patients was assessed in two conditions : without an orthosis and when wearing a new design of unloader knee orthosis . gait analysis was performed to determine alterations to the adduction moment , speed of walking , step length , cadence and knee sagittal plane range of motion during ambulation for the two test conditions . the knee adduction moment was significantly reduced ( p = @ ) , and the speed of walking significantly increased ( p < @ ) when wearing the orthosis . however , a reduction in knee range of motion ( p = @ ) and an increase in step length ( p < @ ) were observed with the orthosis donned . cadence was not significantly altered ( p = @ ) . the use of a new design of unloader knee orthosis as a conservative treatment approach for patients with mild-to-moderate medial compartment osteoarthritis appears warranted . various conservative modalities have been used to reduce pain and improve function in medial compartment osteoarthritis . a new design of an unloader knee orthosis has been developed and is shown to have immediate benefits in patients with mild medial knee osteoarthritis .
24,532,004
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to determine the effects of a small-dose ketamine-propofol combination used for sedation during spinal anesthesia on tourniquet-induced ischemia-reperfusion injury .", "prospective randomized study .", "training and research hospital .", "@ adult , asa physical status @ and @ patients , ages @-@ years , scheduled for elective arthroscopic knee surgery for meniscal and chondral lesions .", "the initial hemodynamic parameters were recorded and blood samples were collected at baseline ( t@ ) ; then spinal anesthesia was performed .", "in group i ( n = @ ) , a combination of @ mg/kg/hr of ketamine and @ mg/kg/hr of propofol was administered ; group ii ( n = @ ) received an equivalent volume of saline as an infusion .", "a pneumatic tourniquet was applied .", "malondialdehyde ( mda ) , superoxide dismutase ( sod ) , and catalase levels were measured one minute before tournique deflation in the ischemic period ( t@ ) , then @ ( t@ ) and @ ( t@ ) minutes following tourniquet deflation in the reperfusion period .", "no differences were noted between groups in hemodynamic data ( p > @ ) or sod levels ( p > @ ) .", "in group i , mda levels at t@ were lower than in group ii ( p < @ ) .", "in group i , catalase levels were lower at t@ and t@ than they were in group ii ( p < @ ) .", "small-dose ketamine-propofol combination may be useful in reducing tourniquet-induced ischemia-reperfusion injury in arthroscopic knee surgery ." ]
to determine the effects of a small-dose ketamine-propofol combination used for sedation during spinal anesthesia on tourniquet-induced ischemia-reperfusion injury . prospective randomized study . training and research hospital . @ adult , asa physical status @ and @ patients , ages @-@ years , scheduled for elective arthroscopic knee surgery for meniscal and chondral lesions . the initial hemodynamic parameters were recorded and blood samples were collected at baseline ( t@ ) ; then spinal anesthesia was performed . in group i ( n = @ ) , a combination of @ mg/kg/hr of ketamine and @ mg/kg/hr of propofol was administered ; group ii ( n = @ ) received an equivalent volume of saline as an infusion . a pneumatic tourniquet was applied . malondialdehyde ( mda ) , superoxide dismutase ( sod ) , and catalase levels were measured one minute before tournique deflation in the ischemic period ( t@ ) , then @ ( t@ ) and @ ( t@ ) minutes following tourniquet deflation in the reperfusion period . no differences were noted between groups in hemodynamic data ( p > @ ) or sod levels ( p > @ ) . in group i , mda levels at t@ were lower than in group ii ( p < @ ) . in group i , catalase levels were lower at t@ and t@ than they were in group ii ( p < @ ) . small-dose ketamine-propofol combination may be useful in reducing tourniquet-induced ischemia-reperfusion injury in arthroscopic knee surgery .
24,444,988
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "black men exhibit a high prevalence of vitamin d deficiency as well as a higher incidence of prostate cancer and higher mortality rates from prostate cancer than whites .", "there are few data about the effect of vitamin d@ ( cholecalciferol ) supplementation on prostate-specific antigen ( psa ) in healthy black men .", "during three winters from @ to @ , @ black men ( median age , @ years ) of boston , ma were randomized into a four-arm , double-blind trial for @ months of placebo , @,@ , @,@ , or @,@ u of vitamin d@ .", "at baseline and @ months , free and total psa was measured .", "with vitamin d supplementation , no significant differences in free and total psa were observed ; free psa , -@ ng/ml ( p = @ ) and total psa , -@ ng/ml ( p = @ ) for each additional @,@ u/d of vitamin d@ .", "within an unselected population of healthy black men without a cancer diagnosis , we found no effect of vitamin d supplementation on free or total psa .", "these findings support prior findings of no change in psa with vitamin d supplementation and emphasize the need for new methods to assess the influence of vitamin d supplementation on prostate cancer prevention ." ]
black men exhibit a high prevalence of vitamin d deficiency as well as a higher incidence of prostate cancer and higher mortality rates from prostate cancer than whites . there are few data about the effect of vitamin d@ ( cholecalciferol ) supplementation on prostate-specific antigen ( psa ) in healthy black men . during three winters from @ to @ , @ black men ( median age , @ years ) of boston , ma were randomized into a four-arm , double-blind trial for @ months of placebo , @,@ , @,@ , or @,@ u of vitamin d@ . at baseline and @ months , free and total psa was measured . with vitamin d supplementation , no significant differences in free and total psa were observed ; free psa , -@ ng/ml ( p = @ ) and total psa , -@ ng/ml ( p = @ ) for each additional @,@ u/d of vitamin d@ . within an unselected population of healthy black men without a cancer diagnosis , we found no effect of vitamin d supplementation on free or total psa . these findings support prior findings of no change in psa with vitamin d supplementation and emphasize the need for new methods to assess the influence of vitamin d supplementation on prostate cancer prevention .
24,974,387
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "treating schizophrenia patients who fail to respond to antipsychotics is a major challenge , and the percentage of treatment-resistant patients is estimated to be @-@ % .", "recent studies indicate that yokukansan ( yks ; d@ and @ht@a partial agonist and @ht@a and glutamate antagonist ) to be safe and useful in treating behavioral and psychological symptoms associated with dementia and other neuropsychiatric conditions .", "we aimed at evaluating both the efficacy and safety of yks in patients with treatment-resistant schizophrenia .", "this randomized , multicenter , double-blind , placebo-controlled study was conducted between may @ and august @ .", "one hundred twenty antipsychotic-treated inpatients from @ psychiatric hospitals in japan were included .", "patients were randomized to adjuvant treatment with yks @ g/day or placebo .", "during a @-week follow-up , psychopathology was assessed using the positive and negative syndrome scale ( panss ) with five factors -lsb- excitement/hostility ( p@ , p@ , g@ , and g@ ) , depression/anxiety ( g@ , g@ , g@ , g@ , and g@ ) , cognition ( p@ , n@ , n@ , g@ , g@ , g@ , g@ , g@ , and g@ -rsb- , positive ( p@ , p@ , p@ , p@ , and g@ ) , and negative ( n@ , n@ , n@ , n@ , n@ , g@ , and g@ -rsb- -rsb- .", "other assessments included , clinical global impression-severity ( cgi-s ) , global assessment of functioning ( gaf ) , and drug-induced extrapyramidal symptoms scale ( diepss ) .", "the primary efficacy outcome was the change in panss five-factor scores .", "the secondary outcomes were changes in the scores of cgi-s .", "the analysis was made on a modified intention to treat basis with the help of a last observation carried forward method .", "yks showed a tendency of superiority to placebo in reducing total all panss five-factor scores in treatment-resistant schizophrenia , but the difference was not statistically significant in total , depression/anxiety , cognition , positive , and negative factors .", "however , compared to the placebo group , the yks group showed statistically significant improvements in the panss excitement/hostility factor scores ( p < @ ) .", "no substantial side effects were recorded .", "the results of the present study indicate yks to be a potential adjunctive treatment strategy for treatment-resistant schizophrenia , particularly to improve excitement/hostility symptoms ." ]
treating schizophrenia patients who fail to respond to antipsychotics is a major challenge , and the percentage of treatment-resistant patients is estimated to be @-@ % . recent studies indicate that yokukansan ( yks ; d@ and @ht@a partial agonist and @ht@a and glutamate antagonist ) to be safe and useful in treating behavioral and psychological symptoms associated with dementia and other neuropsychiatric conditions . we aimed at evaluating both the efficacy and safety of yks in patients with treatment-resistant schizophrenia . this randomized , multicenter , double-blind , placebo-controlled study was conducted between may @ and august @ . one hundred twenty antipsychotic-treated inpatients from @ psychiatric hospitals in japan were included . patients were randomized to adjuvant treatment with yks @ g/day or placebo . during a @-week follow-up , psychopathology was assessed using the positive and negative syndrome scale ( panss ) with five factors -lsb- excitement/hostility ( p@ , p@ , g@ , and g@ ) , depression/anxiety ( g@ , g@ , g@ , g@ , and g@ ) , cognition ( p@ , n@ , n@ , g@ , g@ , g@ , g@ , g@ , and g@ -rsb- , positive ( p@ , p@ , p@ , p@ , and g@ ) , and negative ( n@ , n@ , n@ , n@ , n@ , g@ , and g@ -rsb- -rsb- . other assessments included , clinical global impression-severity ( cgi-s ) , global assessment of functioning ( gaf ) , and drug-induced extrapyramidal symptoms scale ( diepss ) . the primary efficacy outcome was the change in panss five-factor scores . the secondary outcomes were changes in the scores of cgi-s . the analysis was made on a modified intention to treat basis with the help of a last observation carried forward method . yks showed a tendency of superiority to placebo in reducing total all panss five-factor scores in treatment-resistant schizophrenia , but the difference was not statistically significant in total , depression/anxiety , cognition , positive , and negative factors . however , compared to the placebo group , the yks group showed statistically significant improvements in the panss excitement/hostility factor scores ( p < @ ) . no substantial side effects were recorded . the results of the present study indicate yks to be a potential adjunctive treatment strategy for treatment-resistant schizophrenia , particularly to improve excitement/hostility symptoms .
24,923,986
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to evaluate the therapeutic effect on pain in the dressing change after perianal abscess surgery treated with warm suspending moxibustion at changqiang ( gv @ ) .", "one hundred and sixty patients were randomized into a moxibustion group and a far-infrared therapy group , @ cases in each one .", "in the moxibustion group , the warm suspending moxibustion at changqiang ( gv @ ) was applied .", "in the far-infrared therapy group , the infrared ray was radiated at changqiang ( gv @ ) .", "the treatment started in @ min after dressing change in the two groups .", "totally , @ treatments were required .", "the time requirement being equal to or less than @ score in the assessment face scale ( afs ) , the case number of pain relief in @ min after treatment and the intention of the two therapies after everyday dressing change were observed in the patients of the two groups .", "in the moxibustion group , the time of pain relief was shorter than that of the far-infrared therapy group -lsb- ( @ + / - @ ) min vs ( @ + / - @ ) min on the @st day ; ( @ + / - @ ) min vs ( @ + / - @ ) min on the @nd day ; ( @ + / - @ ) min vs ( @ + / - @ ) min on the @rd day ; ( @ + / - @ ) min vs ( @ + / - @ ) min on the @th day ; ( @ + / - @ ) min vs ( @ + / - @ ) min on the @th day ; ( @ + / - @ ) min vs ( @ + / - @ ) min on the @th day ; ( @ + / - @ ) min vs ( @ + / - @ ) min on the @th day ; ( @ + / - @ ) min vs ( @ + / - @ ) min on the @th day , all p < @ -rsb- .", "the case numbers of pain relief in @ min after treatment were @ cases , @ cases , @ cases and @ cases from the @st to the @th day separately in the moxibustion group , which were much more than @ cases , @ cases , @ cases and @ cases in the far-infrared therapy group ( all p < @ ) .", "the treatment intention scores in the moxibustion group were better than those in the far-infrared therapy group ( all p < @ ) .", "the warm suspending moxibustion at changqiang ( gv @ ) relieves pain rapidly in the dressing change of much more patients after perianal abscess surgery in much shorter time as compared with the far-infrared therapy .", "moreover , the patients have more expectation to be treated with moxibustion therapy ." ]
to evaluate the therapeutic effect on pain in the dressing change after perianal abscess surgery treated with warm suspending moxibustion at changqiang ( gv @ ) . one hundred and sixty patients were randomized into a moxibustion group and a far-infrared therapy group , @ cases in each one . in the moxibustion group , the warm suspending moxibustion at changqiang ( gv @ ) was applied . in the far-infrared therapy group , the infrared ray was radiated at changqiang ( gv @ ) . the treatment started in @ min after dressing change in the two groups . totally , @ treatments were required . the time requirement being equal to or less than @ score in the assessment face scale ( afs ) , the case number of pain relief in @ min after treatment and the intention of the two therapies after everyday dressing change were observed in the patients of the two groups . in the moxibustion group , the time of pain relief was shorter than that of the far-infrared therapy group -lsb- ( @ + / - @ ) min vs ( @ + / - @ ) min on the @st day ; ( @ + / - @ ) min vs ( @ + / - @ ) min on the @nd day ; ( @ + / - @ ) min vs ( @ + / - @ ) min on the @rd day ; ( @ + / - @ ) min vs ( @ + / - @ ) min on the @th day ; ( @ + / - @ ) min vs ( @ + / - @ ) min on the @th day ; ( @ + / - @ ) min vs ( @ + / - @ ) min on the @th day ; ( @ + / - @ ) min vs ( @ + / - @ ) min on the @th day ; ( @ + / - @ ) min vs ( @ + / - @ ) min on the @th day , all p < @ -rsb- . the case numbers of pain relief in @ min after treatment were @ cases , @ cases , @ cases and @ cases from the @st to the @th day separately in the moxibustion group , which were much more than @ cases , @ cases , @ cases and @ cases in the far-infrared therapy group ( all p < @ ) . the treatment intention scores in the moxibustion group were better than those in the far-infrared therapy group ( all p < @ ) . the warm suspending moxibustion at changqiang ( gv @ ) relieves pain rapidly in the dressing change of much more patients after perianal abscess surgery in much shorter time as compared with the far-infrared therapy . moreover , the patients have more expectation to be treated with moxibustion therapy .
24,673,045
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to prospectively assess the antiinflammatory effect of volatile anesthetic sevoflurane in patients undergoing open lung surgery with one lung ventilation ( olv ) .", "this prospective , randomized study included @ patients undergoing thoracic surgery with olv ( nct@ ) .", "the patients were randomly allocated into two equal groups that received either propofol or sevoflurane .", "four patients were excluded from the study because after surgery they received blood transfusion or non-steroid antiinflammatory drugs .", "inflammatory mediators ( interleukins @ , @ , and @ , c-reactive protein -lsb- crp -rsb- , and procalcitonin ) were measured perioperatively .", "the infiltration of the nonoperated lung was assessed on chest x-rays and the oxygenation index was calculated .", "the major postoperative complications were counted .", "interleukin @ levels were significantly higher in propofol than in sevoflurane group ( p = @ ) .", "preoperative crp levels did not differ between the groups ( p = @ ) and in all patients they were lower than @ mg/l , but postoperative crp was significantly higher in propofol group ( @ vs @ ng/l ; p = @ ) ; pre - and postoperative procalcitonin was within the reference range ( < @ g/l ) in both groups .", "the oxygenation index was significantly lower in propofol group ( @ vs @ ; p = @ ) .", "there was no significant difference between the groups in lung infiltrates ( p = @ ) .", "the number of postoperative adverse events was higher in propofol group , but the difference was not-significant ( @ vs @ ; p = @ ) .", "the study suggests an antiinflammatory effect of sevoflurane in patients undergoing thoracotomy with olv ." ]
to prospectively assess the antiinflammatory effect of volatile anesthetic sevoflurane in patients undergoing open lung surgery with one lung ventilation ( olv ) . this prospective , randomized study included @ patients undergoing thoracic surgery with olv ( nct@ ) . the patients were randomly allocated into two equal groups that received either propofol or sevoflurane . four patients were excluded from the study because after surgery they received blood transfusion or non-steroid antiinflammatory drugs . inflammatory mediators ( interleukins @ , @ , and @ , c-reactive protein -lsb- crp -rsb- , and procalcitonin ) were measured perioperatively . the infiltration of the nonoperated lung was assessed on chest x-rays and the oxygenation index was calculated . the major postoperative complications were counted . interleukin @ levels were significantly higher in propofol than in sevoflurane group ( p = @ ) . preoperative crp levels did not differ between the groups ( p = @ ) and in all patients they were lower than @ mg/l , but postoperative crp was significantly higher in propofol group ( @ vs @ ng/l ; p = @ ) ; pre - and postoperative procalcitonin was within the reference range ( < @ g/l ) in both groups . the oxygenation index was significantly lower in propofol group ( @ vs @ ; p = @ ) . there was no significant difference between the groups in lung infiltrates ( p = @ ) . the number of postoperative adverse events was higher in propofol group , but the difference was not-significant ( @ vs @ ; p = @ ) . the study suggests an antiinflammatory effect of sevoflurane in patients undergoing thoracotomy with olv .
25,559,834
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "there is a paucity of controlled treatment trials for the treatment of conversion disorder , seizures type , also known as psychogenic nonepileptic seizures ( pnes ) .", "psychogenic nonepileptic seizures , the most common conversion disorder , are as disabling as epilepsy and are not adequately addressed or treated by mental health clinicians .", "to evaluate different pnes treatments compared with standard medical care ( treatment as usual ) .", "pilot randomized clinical trial at @ academic medical centers with mental health clinicians trained to administer psychotherapy or psychopharmacology to outpatients with pnes .", "thirty-eight participants were randomized in a blocked schedule among @ sites to @ of @ treatment arms and were followed up for @ weeks between september @ and february @ ; @ were included in the analysis .", "medication ( flexible-dose sertraline hydrochloride ) only , cognitive behavioral therapy informed psychotherapy ( cbt-ip ) only , cbt-ip with medication ( sertraline ) , or treatment as usual .", "seizure frequency was the primary outcome ; psychosocial and functioning measures , including psychiatric symptoms , social interactions , quality of life , and global functioning , were secondary outcomes .", "data were collected prospectively , weekly , and with baseline , week @ , midpoint ( week @ ) , and exit ( week @ ) batteries .", "within-group analyses for each arm were performed on primary ( seizure frequency ) and secondary outcomes from treatment-blinded raters using an intention-to-treat analysis .", "the psychotherapy ( cbt-ip ) arm showed a @ % seizure reduction ( p = @ ) and significant improvement from baseline in secondary measures including depression , anxiety , quality of life , and global functioning ( p < @ ) .", "the combined arm ( cbt-ip with sertraline ) showed @ % seizure reduction ( p = @ ) and significant improvements in some secondary measures , including global functioning ( p = @ ) .", "the sertraline-only arm did not show a reduction in seizures ( p = @ ) .", "the treatment as usual group showed no significant seizure reduction or improvement in secondary outcome measures ( p = @ ) .", "this pilot randomized clinical trial for pnes revealed significant seizure reduction and improved comorbid symptoms and global functioning with cbt-ip for pnes without and with sertraline .", "there were no improvements in the sertraline-only or treatment-as-usual arms .", "this study supports the use of manualized psychotherapy for pnes and successful training of mental health clinicians in the treatment .", "future studies could assess larger-scale intervention dissemination .", "clinicaltrials.gov identifier : nct@ ." ]
there is a paucity of controlled treatment trials for the treatment of conversion disorder , seizures type , also known as psychogenic nonepileptic seizures ( pnes ) . psychogenic nonepileptic seizures , the most common conversion disorder , are as disabling as epilepsy and are not adequately addressed or treated by mental health clinicians . to evaluate different pnes treatments compared with standard medical care ( treatment as usual ) . pilot randomized clinical trial at @ academic medical centers with mental health clinicians trained to administer psychotherapy or psychopharmacology to outpatients with pnes . thirty-eight participants were randomized in a blocked schedule among @ sites to @ of @ treatment arms and were followed up for @ weeks between september @ and february @ ; @ were included in the analysis . medication ( flexible-dose sertraline hydrochloride ) only , cognitive behavioral therapy informed psychotherapy ( cbt-ip ) only , cbt-ip with medication ( sertraline ) , or treatment as usual . seizure frequency was the primary outcome ; psychosocial and functioning measures , including psychiatric symptoms , social interactions , quality of life , and global functioning , were secondary outcomes . data were collected prospectively , weekly , and with baseline , week @ , midpoint ( week @ ) , and exit ( week @ ) batteries . within-group analyses for each arm were performed on primary ( seizure frequency ) and secondary outcomes from treatment-blinded raters using an intention-to-treat analysis . the psychotherapy ( cbt-ip ) arm showed a @ % seizure reduction ( p = @ ) and significant improvement from baseline in secondary measures including depression , anxiety , quality of life , and global functioning ( p < @ ) . the combined arm ( cbt-ip with sertraline ) showed @ % seizure reduction ( p = @ ) and significant improvements in some secondary measures , including global functioning ( p = @ ) . the sertraline-only arm did not show a reduction in seizures ( p = @ ) . the treatment as usual group showed no significant seizure reduction or improvement in secondary outcome measures ( p = @ ) . this pilot randomized clinical trial for pnes revealed significant seizure reduction and improved comorbid symptoms and global functioning with cbt-ip for pnes without and with sertraline . there were no improvements in the sertraline-only or treatment-as-usual arms . this study supports the use of manualized psychotherapy for pnes and successful training of mental health clinicians in the treatment . future studies could assess larger-scale intervention dissemination . clinicaltrials.gov identifier : nct@ .
24,989,152
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "this study compared the therapeutic effects of collateral meridian therapy ( cmt ) with traditional acupoint pressure therapy ( apt ) in patients with unilateral upper back pain .", "forty-nine patients with active myofascial trigger points in upper trapezius muscle were randomly allocated to the control ( ctl ) , apt , or cmt group .", "each subject in the cmt and apt groups received @ sessions of treatment per week over @ month .", "patients in the apt and cmt groups showed significant improvements @ month after treatment in visual analogue scale , range of motion , pain pressure threshold , regional superficial blood flow , and physical health , as compared to the ctl group .", "no significant differences in outcome measures were found between apt and cmt groups @ month after treatment .", "both apt and cmt have comparable therapeutic efficacy in the treatment of unilateral upper back pain with active myofascial trigger points in the upper trapezius muscle ." ]
this study compared the therapeutic effects of collateral meridian therapy ( cmt ) with traditional acupoint pressure therapy ( apt ) in patients with unilateral upper back pain . forty-nine patients with active myofascial trigger points in upper trapezius muscle were randomly allocated to the control ( ctl ) , apt , or cmt group . each subject in the cmt and apt groups received @ sessions of treatment per week over @ month . patients in the apt and cmt groups showed significant improvements @ month after treatment in visual analogue scale , range of motion , pain pressure threshold , regional superficial blood flow , and physical health , as compared to the ctl group . no significant differences in outcome measures were found between apt and cmt groups @ month after treatment . both apt and cmt have comparable therapeutic efficacy in the treatment of unilateral upper back pain with active myofascial trigger points in the upper trapezius muscle .
25,454,967
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "it remains unknown whether local anaesthetic dose is the only factor influencing continuous popliteal-sciatic nerve block effects , or whether concentration , volume , or both exert an influence as well .", "bilateral sciatic catheters were inserted in volunteers ( n = @ ) .", "catheters were randomly assigned to ropivacaine of either @ % ( @ ml h ( -@ ) ) or @ % ( @ ml h ( -@ ) ) for @ h.", "the primary endpoint was the tolerance to transcutaneous electrical stimulation within the tibial nerve distribution at hour @ .", "secondary endpoints included current tolerance at other time points and plantar flexion maximum voluntary isometric contraction ( @ h total ) .", "at hour @ , tolerance to cutaneous stimulation for limbs receiving @ % ropivacaine was -lsb- mean ( standard deviation ) -rsb- @ ( @ ) vs@ @ ( @ ) ma for limbs receiving @ % -lsb- estimated mean difference @ ma ; @ % confidence interval ( ci ) -@ to @ ; p = @ and @ for lower and upper boundaries , respectively -rsb- .", "because the @ % ci fell within the prespecified tolerance @ ma , we conclude that the effect of the two concentration/volume combinations were equivalent .", "similar negative findings were found for the secondary outcomes .", "for continuous popliteal-sciatic nerve blocks , we found no evidence that local anaesthetic concentration and volume influence block characteristics , suggesting that local anaesthetic dose ( mass ) is the primary determinant of perineural infusion effects in this anatomic location .", "these findings suggest that for ambulatory perineural local anaesthetic infusion-for which there is usually a finite local anaesthetic reservoir-decreasing the basal rate while increasing the local anaesthetic concentration may allow for increased infusion duration without compromising postoperative analgesia .", "nct@ ." ]
it remains unknown whether local anaesthetic dose is the only factor influencing continuous popliteal-sciatic nerve block effects , or whether concentration , volume , or both exert an influence as well . bilateral sciatic catheters were inserted in volunteers ( n = @ ) . catheters were randomly assigned to ropivacaine of either @ % ( @ ml h ( -@ ) ) or @ % ( @ ml h ( -@ ) ) for @ h. the primary endpoint was the tolerance to transcutaneous electrical stimulation within the tibial nerve distribution at hour @ . secondary endpoints included current tolerance at other time points and plantar flexion maximum voluntary isometric contraction ( @ h total ) . at hour @ , tolerance to cutaneous stimulation for limbs receiving @ % ropivacaine was -lsb- mean ( standard deviation ) -rsb- @ ( @ ) vs@ @ ( @ ) ma for limbs receiving @ % -lsb- estimated mean difference @ ma ; @ % confidence interval ( ci ) -@ to @ ; p = @ and @ for lower and upper boundaries , respectively -rsb- . because the @ % ci fell within the prespecified tolerance @ ma , we conclude that the effect of the two concentration/volume combinations were equivalent . similar negative findings were found for the secondary outcomes . for continuous popliteal-sciatic nerve blocks , we found no evidence that local anaesthetic concentration and volume influence block characteristics , suggesting that local anaesthetic dose ( mass ) is the primary determinant of perineural infusion effects in this anatomic location . these findings suggest that for ambulatory perineural local anaesthetic infusion-for which there is usually a finite local anaesthetic reservoir-decreasing the basal rate while increasing the local anaesthetic concentration may allow for increased infusion duration without compromising postoperative analgesia . nct@ .
25,248,648
[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "in voice , a multisite hiv pre-exposure prophylaxis ( prep ) trial , plasma drug levels pointed to widespread product nonuse , despite high adherence estimated by self-reports and clinic product counts .", "using a socio-ecological framework ( sef ) , we explored socio-cultural and contextual factors that influenced participants ' experience of daily vaginal gel and oral tablet regimens in voice .", "in johannesburg , a qualitative ancillary study was concurrently conducted among randomly selected voice participants assigned to in-depth interviews ( n = @ ) , serial ethnographic interviews ( n = @ ) , or focus group discussions ( n = @ ) .", "audiotaped interviews were transcribed , translated , and coded thematically for analysis .", "of the @ participants , the mean age was @ years , and @ % had a primary sex partner with whom @ % cohabitated .", "few women reported lasting nonuse , which they typically attributed to missed visits , lack of product replenishments , and family-related travel or work .", "women acknowledged occasionally skipping or mistiming doses because they forgot , were busy , felt lazy or bored , feared or experienced side effects .", "however , nearly all knew or heard of other study participants who did not use products daily .", "three overarching themes emerged from further analyses : ambivalence toward research , preserving a healthy status , and managing social relationships .", "these themes highlighted the profound and complex meanings associated with participating in a blinded hiv prep trial and taking antiretroviral-based products .", "the unknown efficacy of products , their connection with hiv infection , challenges with daily regimen given social risks , lack of support-from partners and significant others-and the relationship tradeoffs entailed by using the products appear to discourage adequate product use .", "personal acknowledgment of product nonuse was challenging .", "this qualitative inquiry highlighted key influences at all sef levels that shaped women 's perceptions of trial participation and experiences with investigational products .", "whether these impacted women 's behaviors and may have contributed to ineffective trial results warrants further investigation ." ]
in voice , a multisite hiv pre-exposure prophylaxis ( prep ) trial , plasma drug levels pointed to widespread product nonuse , despite high adherence estimated by self-reports and clinic product counts . using a socio-ecological framework ( sef ) , we explored socio-cultural and contextual factors that influenced participants ' experience of daily vaginal gel and oral tablet regimens in voice . in johannesburg , a qualitative ancillary study was concurrently conducted among randomly selected voice participants assigned to in-depth interviews ( n = @ ) , serial ethnographic interviews ( n = @ ) , or focus group discussions ( n = @ ) . audiotaped interviews were transcribed , translated , and coded thematically for analysis . of the @ participants , the mean age was @ years , and @ % had a primary sex partner with whom @ % cohabitated . few women reported lasting nonuse , which they typically attributed to missed visits , lack of product replenishments , and family-related travel or work . women acknowledged occasionally skipping or mistiming doses because they forgot , were busy , felt lazy or bored , feared or experienced side effects . however , nearly all knew or heard of other study participants who did not use products daily . three overarching themes emerged from further analyses : ambivalence toward research , preserving a healthy status , and managing social relationships . these themes highlighted the profound and complex meanings associated with participating in a blinded hiv prep trial and taking antiretroviral-based products . the unknown efficacy of products , their connection with hiv infection , challenges with daily regimen given social risks , lack of support-from partners and significant others-and the relationship tradeoffs entailed by using the products appear to discourage adequate product use . personal acknowledgment of product nonuse was challenging . this qualitative inquiry highlighted key influences at all sef levels that shaped women 's perceptions of trial participation and experiences with investigational products . whether these impacted women 's behaviors and may have contributed to ineffective trial results warrants further investigation .
24,586,534
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to improve the quality of eradication therapy ( et ) , by increasing patient compliance .", "an open-label cohort multicenter randomized study was conducted .", "a total of @ patients with helicobacter pylori infection-associated diseases and indications for et were examined .", "work was done to improve compliance in a study patient group before treatment .", "in the study group of patients motivated for treatment , the efficiency of et was significantly higher than in the control group .", "the factors influencing treatment adherence were identified and methods to optimize compliance during h. pylori eradication were developed .", "awareness of the essence of the disease in a patient and his higher motivation for compliance are one of the components of successful h. pylori eradication ." ]
to improve the quality of eradication therapy ( et ) , by increasing patient compliance . an open-label cohort multicenter randomized study was conducted . a total of @ patients with helicobacter pylori infection-associated diseases and indications for et were examined . work was done to improve compliance in a study patient group before treatment . in the study group of patients motivated for treatment , the efficiency of et was significantly higher than in the control group . the factors influencing treatment adherence were identified and methods to optimize compliance during h. pylori eradication were developed . awareness of the essence of the disease in a patient and his higher motivation for compliance are one of the components of successful h. pylori eradication .
24,772,504
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "motor learning results in changes of movement representation in primary motor cortex ( m@ ) a process involving long-term potentiation ( ltp ) .", "pairing motor training with repetitive transcranial magnetic stimulation ( rtms ) of m@ enhances the formation of a motor memory .", "here we determined the effect of pairing m@ stimulation and the execution of training movements at different times and frequencies on the formation of a motor memory .", "formation of a motor memory was defined as increases in motor evoked potentials ( mep ) of the training agonist ( extensor carpi ulnaris muscle , ecu ) and increases in peak acceleration of the trained movements that last more than @min .", "training consisted of auditory-paced ballistic wrist extension movements ( @min , @ hz ) paired with @ , @ or @ hz subthreshold rtms .", "the rtms pulse was applied at either the onset , @ms prior to or @ms after the onset of training movement related increases in electromyographic ( emg ) activity of ecu .", "this was compared to a sham condition .", "only @ hz rtms applied at the onset of the training related increase in ecu-emg activity resulted in increases in mep amplitudes and peak acceleration when compared to the sham .", "the formation of motor memory is enhanced above the nave level by co-administration of low frequency rtms at the time of execution of training movements .", "these results indicate the importance of time and frequency of rtms in these settings and should be considered in the design of rehabilitation treatment strategies using rtms ." ]
motor learning results in changes of movement representation in primary motor cortex ( m@ ) a process involving long-term potentiation ( ltp ) . pairing motor training with repetitive transcranial magnetic stimulation ( rtms ) of m@ enhances the formation of a motor memory . here we determined the effect of pairing m@ stimulation and the execution of training movements at different times and frequencies on the formation of a motor memory . formation of a motor memory was defined as increases in motor evoked potentials ( mep ) of the training agonist ( extensor carpi ulnaris muscle , ecu ) and increases in peak acceleration of the trained movements that last more than @min . training consisted of auditory-paced ballistic wrist extension movements ( @min , @ hz ) paired with @ , @ or @ hz subthreshold rtms . the rtms pulse was applied at either the onset , @ms prior to or @ms after the onset of training movement related increases in electromyographic ( emg ) activity of ecu . this was compared to a sham condition . only @ hz rtms applied at the onset of the training related increase in ecu-emg activity resulted in increases in mep amplitudes and peak acceleration when compared to the sham . the formation of motor memory is enhanced above the nave level by co-administration of low frequency rtms at the time of execution of training movements . these results indicate the importance of time and frequency of rtms in these settings and should be considered in the design of rehabilitation treatment strategies using rtms .
25,113,275
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "various devices have been developed to facilitate liver transection and reduce blood loss in liver resections .", "none of these has proven superiority compared with the classical clamp-crushing technique .", "this randomized clinical trial compared the effectiveness and safety of stapler transection with that of clamp-crushing during open liver resection .", "patients admitted for elective open liver resection between january @ and october @ were assigned randomly to stapler transection or the clamp-crushing technique .", "the primary endpoint was the total amount of intraoperative blood loss .", "secondary endpoints included transection time , duration of operation , complication rates and resection margins .", "a total of @ patients were enrolled , @ to clamp-crushing and @ to stapler transection .", "there was no difference between groups in total intraoperative blood loss : median ( i.q.r. ) @ ( @-@ ) versus @ ( @-@ ) ml respectively ( p = @ ) .", "the difference in total intraoperative blood loss normalized to the transection surface area was not statistically significant ( p = @ ) .", "blood loss during parenchymal transection was significantly lower in the stapler transection group ( p = @ ) , as were the parenchymal transection time ( mean ( s.d. ) @ ( @ ) versus @ ( @ ) min for clamp-crushing and stapler transection groups respectively ; p < @ ) and total duration of operation ( mean ( s.d. ) @ ( @ ) versus @ ( @ ) min ; p = @ ) .", "there were no significant differences in postoperative morbidity ( p = @ ) or mortality ( p = @ ) between groups .", "stapler transection is a safe technique but does not reduce intraoperative blood loss in elective liver resection compared with the clamp-crushing technique .", "nct@ ( http://www.clinicaltrials.gov ) ." ]
various devices have been developed to facilitate liver transection and reduce blood loss in liver resections . none of these has proven superiority compared with the classical clamp-crushing technique . this randomized clinical trial compared the effectiveness and safety of stapler transection with that of clamp-crushing during open liver resection . patients admitted for elective open liver resection between january @ and october @ were assigned randomly to stapler transection or the clamp-crushing technique . the primary endpoint was the total amount of intraoperative blood loss . secondary endpoints included transection time , duration of operation , complication rates and resection margins . a total of @ patients were enrolled , @ to clamp-crushing and @ to stapler transection . there was no difference between groups in total intraoperative blood loss : median ( i.q.r. ) @ ( @-@ ) versus @ ( @-@ ) ml respectively ( p = @ ) . the difference in total intraoperative blood loss normalized to the transection surface area was not statistically significant ( p = @ ) . blood loss during parenchymal transection was significantly lower in the stapler transection group ( p = @ ) , as were the parenchymal transection time ( mean ( s.d. ) @ ( @ ) versus @ ( @ ) min for clamp-crushing and stapler transection groups respectively ; p < @ ) and total duration of operation ( mean ( s.d. ) @ ( @ ) versus @ ( @ ) min ; p = @ ) . there were no significant differences in postoperative morbidity ( p = @ ) or mortality ( p = @ ) between groups . stapler transection is a safe technique but does not reduce intraoperative blood loss in elective liver resection compared with the clamp-crushing technique . nct@ ( http://www.clinicaltrials.gov ) .
24,402,888
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]
[ "the effect of oral polio vaccine administered already at birth ( opv@ ) on child survival was not examined before being recommended in @ .", "observational data suggested that opv@ was harmful for boys , and trials have shown that neonatal vitamin a supplementation ( nvas ) at birth may be beneficial for boys .", "we set out to test this research question in a randomised trial .", "the trial was carried out at the bandim health project , guinea-bissau .", "we planned to enrol @ low-birth weight ( lbw ) boys in a randomised trial to investigate whether nvas instead of opv@ could lower infant mortality for lbw boys .", "at birth , the children were randomised to opv ( usual treatment ) or vas ( intervention treatment ) and followed for @ months for growth and @ months for survival .", "hazard ratios ( hr ) for mortality were calculated using cox regression .", "we compared the individual anthropometry measurements to the @ who growth reference .", "we compared differences in z-scores by linear regression .", "relative risks ( rr ) of being stunted or underweight were calculated in poisson regression models with robust standard errors .", "in the rainy season we detected a cluster of deaths in the vas group and the trial was halted immediately with @ boys enrolled .", "the vas group had significantly higher mortality than the opv@ group in the rainy season ( hr : @ ( @ - @ ) ) .", "all deaths had had contact with the neonatal nursery ; of seven vas boys enrolled during one week in september , six died within two months of age , whereas only one died among the six boys receiving opv ( p = @ ) .", "growth ( weight and arm-circumference ) in the vas group was significantly worse until age @ months .", "vas at birth instead of opv was not beneficial for the lbw boys in this study .", "with the premature closure of the trial it was not possible to answer the research question .", "however , the results of this study call for extra caution when testing the effect of nvas in the future .", "http://www.clinicaltrials.govnct@ .", "registered @ february @ ." ]
the effect of oral polio vaccine administered already at birth ( opv@ ) on child survival was not examined before being recommended in @ . observational data suggested that opv@ was harmful for boys , and trials have shown that neonatal vitamin a supplementation ( nvas ) at birth may be beneficial for boys . we set out to test this research question in a randomised trial . the trial was carried out at the bandim health project , guinea-bissau . we planned to enrol @ low-birth weight ( lbw ) boys in a randomised trial to investigate whether nvas instead of opv@ could lower infant mortality for lbw boys . at birth , the children were randomised to opv ( usual treatment ) or vas ( intervention treatment ) and followed for @ months for growth and @ months for survival . hazard ratios ( hr ) for mortality were calculated using cox regression . we compared the individual anthropometry measurements to the @ who growth reference . we compared differences in z-scores by linear regression . relative risks ( rr ) of being stunted or underweight were calculated in poisson regression models with robust standard errors . in the rainy season we detected a cluster of deaths in the vas group and the trial was halted immediately with @ boys enrolled . the vas group had significantly higher mortality than the opv@ group in the rainy season ( hr : @ ( @ - @ ) ) . all deaths had had contact with the neonatal nursery ; of seven vas boys enrolled during one week in september , six died within two months of age , whereas only one died among the six boys receiving opv ( p = @ ) . growth ( weight and arm-circumference ) in the vas group was significantly worse until age @ months . vas at birth instead of opv was not beneficial for the lbw boys in this study . with the premature closure of the trial it was not possible to answer the research question . however , the results of this study call for extra caution when testing the effect of nvas in the future . http://www.clinicaltrials.govnct@ . registered @ february @ .
25,163,399
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND" ]
[ "dual orexin receptor antagonists ( doras ) enable initiation and maintenance of sleep in patients with primary insomnia .", "blockade of the orexin system has shown reduction of drug-seeking behavior in animal studies , supporting the role of orexin antagonism as a novel approach for treating substance abuse .", "since hypnotics are traditionally associated with misuse , a lack of abuse liability of doras would offer significant benefits over current therapies for sleep disorders .", "in this randomized , crossover , proof-of-concept study , single oral doses of the dora almorexant ( @ , @ , and @,@ mg ) were administered to healthy subjects with previous non-therapeutic experience with central nervous system depressants and were compared with placebo and single oral doses of zolpidem ( @ and @ mg ) , a benzodiazepine-like drug .", "subjective measures of abuse potential ( visual analog scales -lsb- vas -rsb- , addiction research center inventory , and subjective drug value ) and objective measures ( divided attention -lsb- da -rsb- ) were evaluated over @ h post-dose in @ evaluable subjects .", "drug liking vas peak effect ( e max ; primary endpoint ) was significantly higher for all doses of almorexant and zolpidem compared with placebo ( p < @ ) .", "almorexant @ mg showed significantly less ` drug liking ' than both zolpidem doses ( p < @ ) , and almorexant @ mg had smaller effects than zolpidem @ mg ( p < @ ) , while almorexant @,@ mg was not different from either zolpidem dose .", "results were similar for other subjective measures , although almorexant generally showed smaller negative and perceptual effects compared with zolpidem .", "almorexant also showed less cognitive impairment compared with zolpidem on most da endpoints .", "this study in humans investigating single doses of almorexant is the first to explore and show abuse liability of a dora , a class of compounds that is not only promising for the treatment of sleep disorders , but also of addiction ." ]
dual orexin receptor antagonists ( doras ) enable initiation and maintenance of sleep in patients with primary insomnia . blockade of the orexin system has shown reduction of drug-seeking behavior in animal studies , supporting the role of orexin antagonism as a novel approach for treating substance abuse . since hypnotics are traditionally associated with misuse , a lack of abuse liability of doras would offer significant benefits over current therapies for sleep disorders . in this randomized , crossover , proof-of-concept study , single oral doses of the dora almorexant ( @ , @ , and @,@ mg ) were administered to healthy subjects with previous non-therapeutic experience with central nervous system depressants and were compared with placebo and single oral doses of zolpidem ( @ and @ mg ) , a benzodiazepine-like drug . subjective measures of abuse potential ( visual analog scales -lsb- vas -rsb- , addiction research center inventory , and subjective drug value ) and objective measures ( divided attention -lsb- da -rsb- ) were evaluated over @ h post-dose in @ evaluable subjects . drug liking vas peak effect ( e max ; primary endpoint ) was significantly higher for all doses of almorexant and zolpidem compared with placebo ( p < @ ) . almorexant @ mg showed significantly less ` drug liking ' than both zolpidem doses ( p < @ ) , and almorexant @ mg had smaller effects than zolpidem @ mg ( p < @ ) , while almorexant @,@ mg was not different from either zolpidem dose . results were similar for other subjective measures , although almorexant generally showed smaller negative and perceptual effects compared with zolpidem . almorexant also showed less cognitive impairment compared with zolpidem on most da endpoints . this study in humans investigating single doses of almorexant is the first to explore and show abuse liability of a dora , a class of compounds that is not only promising for the treatment of sleep disorders , but also of addiction .
24,627,301
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "music therapy is an innovative approach to support people with severe mental illness ( smi ) .", "the aim of the study was to determine whether group music therapy ( gmt ) positively impacted on quality of life ( qol ) , social enrichment , self-esteem , spirituality and psychiatric symptoms of participants with smi and how they experienced the intervention .", "the primary outcome was qol ; secondary measures assessed social enrichment , self-esteem , spirituality and psychiatric symptoms .", "the @-week intervention comprised singing familiar songs and composing original songs recorded in a professional studio .", "qualitative data were generated from focus group interviews and song lyric analysis .", "ninety-nine adults ( @ female ) were recruited , with an initial cohort ( n = @ ) randomized to either : weekly gmt followed by standard care ( sc ) or sc followed by gmt .", "crossover occurred after @ weeks .", "measures were conducted at baseline , @ , @ and @ weeks .", "a second cohort ( n = @ ) could not be randomized and were assigned to gmt followed by sc .", "intention-to-treat analysis showed a significant difference between gmt and sc on qol and spirituality .", "this was robust to different assumptions about missing data ( listwise deletion , last observation carried forward or multiple imputation ) .", "per-protocol analysis suggested greater benefit for those receiving more sessions .", "focus group interview and song lyric analyses suggested that gmt was enjoyable ; self-esteem was enhanced ; participants appreciated therapists and peers ; and although challenges were experienced , the programme was recommended to others .", "group music therapy may enhance qol and spirituality of persons with smi ." ]
music therapy is an innovative approach to support people with severe mental illness ( smi ) . the aim of the study was to determine whether group music therapy ( gmt ) positively impacted on quality of life ( qol ) , social enrichment , self-esteem , spirituality and psychiatric symptoms of participants with smi and how they experienced the intervention . the primary outcome was qol ; secondary measures assessed social enrichment , self-esteem , spirituality and psychiatric symptoms . the @-week intervention comprised singing familiar songs and composing original songs recorded in a professional studio . qualitative data were generated from focus group interviews and song lyric analysis . ninety-nine adults ( @ female ) were recruited , with an initial cohort ( n = @ ) randomized to either : weekly gmt followed by standard care ( sc ) or sc followed by gmt . crossover occurred after @ weeks . measures were conducted at baseline , @ , @ and @ weeks . a second cohort ( n = @ ) could not be randomized and were assigned to gmt followed by sc . intention-to-treat analysis showed a significant difference between gmt and sc on qol and spirituality . this was robust to different assumptions about missing data ( listwise deletion , last observation carried forward or multiple imputation ) . per-protocol analysis suggested greater benefit for those receiving more sessions . focus group interview and song lyric analyses suggested that gmt was enjoyable ; self-esteem was enhanced ; participants appreciated therapists and peers ; and although challenges were experienced , the programme was recommended to others . group music therapy may enhance qol and spirituality of persons with smi .
24,256,453
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to test the application in practice of computerized fetal heart rate ( fhr ) analysis in pregnancy .", "randomized distribution of subjects with computerized analysis automatically revealed or concealed .", "a district general hospital and a teaching hospital outside london .", "@ pregnant women studied within a year .", "quality and duration of the cardiotocogram ; quantitative measurement of fhr variation ; number of stillbirths .", "with interactive advice to the operator , records were of improved quality ( up to @ % without signal loss ) with potentially much reduced recording time .", "the short-term fhr variation measured in the last records before intervention is reported for the first time .", "the benefits of using the computers include improvement in record quality and saving of time .", "in addition , where interpretation depended on estimation of fhr variation there was prima facie evidence of observer misinterpretation ; visual analysis was unreliable .", "a larger trial is now required with more rigorous constraints on intervention ." ]
to test the application in practice of computerized fetal heart rate ( fhr ) analysis in pregnancy . randomized distribution of subjects with computerized analysis automatically revealed or concealed . a district general hospital and a teaching hospital outside london . @ pregnant women studied within a year . quality and duration of the cardiotocogram ; quantitative measurement of fhr variation ; number of stillbirths . with interactive advice to the operator , records were of improved quality ( up to @ % without signal loss ) with potentially much reduced recording time . the short-term fhr variation measured in the last records before intervention is reported for the first time . the benefits of using the computers include improvement in record quality and saving of time . in addition , where interpretation depended on estimation of fhr variation there was prima facie evidence of observer misinterpretation ; visual analysis was unreliable . a larger trial is now required with more rigorous constraints on intervention .
25,488,080
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "widespread use of @-valent pneumococcal conjugate vaccine ( pcv@ ) in children has led to significant reduction in pneumococcal disease in children and adults .", "however , diseases caused by serotypes not included in pcv@ have increased .", "a @-valent pneumococcal conjugate vaccine ( pcv@ ) containing serotypes in pcv@ and @ additional serotypes ( @ , @ , @ , @a , @f , @a , @f , @f ) was developed and evaluated in toddlers @ to @ months of age .", "ninety toddlers who completed an infant series with pcv@ received a single dose of either aluminum-adjuvanted pcv@ , nonadjuvanted pcv@ , or pcv@ .", "injection-site and systemic adverse events ( aes ) were collected for @ days postvaccination and serious aes ( saes ) were collected for @ days postvaccination .", "solicited aes included local ( pain/tenderness , swelling , nodule and redness ) and systemic ( fatigue , arthralgia and myalgia ) aes .", "serotype-specific immunoglobulin g ( igg ) and opsonophagocytic ( opa ) responses were measured immediately prior and @ days postvaccination .", "incidences of local and systemic aes were comparable across vaccine groups .", "the majority of reported events , regardless of vaccine received , were transient and of mild to moderate intensity .", "no clinically significant differences were observed when comparing duration and severity of aes .", "no vaccine-related saes or discontinuations from the study due to aes were reported .", "pneumococcal igg concentrations and opa titers increased postvaccination , with appreciable fold rises for all serotypes .", "antibody levels were comparable between both pcv@ formulations and generally comparable to pcv@ for the shared serotypes .", "both formulations of pcv@ display acceptable safety profiles and induce igg and opa responses to all vaccine serotypes ." ]
widespread use of @-valent pneumococcal conjugate vaccine ( pcv@ ) in children has led to significant reduction in pneumococcal disease in children and adults . however , diseases caused by serotypes not included in pcv@ have increased . a @-valent pneumococcal conjugate vaccine ( pcv@ ) containing serotypes in pcv@ and @ additional serotypes ( @ , @ , @ , @a , @f , @a , @f , @f ) was developed and evaluated in toddlers @ to @ months of age . ninety toddlers who completed an infant series with pcv@ received a single dose of either aluminum-adjuvanted pcv@ , nonadjuvanted pcv@ , or pcv@ . injection-site and systemic adverse events ( aes ) were collected for @ days postvaccination and serious aes ( saes ) were collected for @ days postvaccination . solicited aes included local ( pain/tenderness , swelling , nodule and redness ) and systemic ( fatigue , arthralgia and myalgia ) aes . serotype-specific immunoglobulin g ( igg ) and opsonophagocytic ( opa ) responses were measured immediately prior and @ days postvaccination . incidences of local and systemic aes were comparable across vaccine groups . the majority of reported events , regardless of vaccine received , were transient and of mild to moderate intensity . no clinically significant differences were observed when comparing duration and severity of aes . no vaccine-related saes or discontinuations from the study due to aes were reported . pneumococcal igg concentrations and opa titers increased postvaccination , with appreciable fold rises for all serotypes . antibody levels were comparable between both pcv@ formulations and generally comparable to pcv@ for the shared serotypes . both formulations of pcv@ display acceptable safety profiles and induce igg and opa responses to all vaccine serotypes .
25,741,971
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the feedback intervention trial was a national trial of an intervention to increase hand hygiene behavior in english and welsh hospitals .", "it significantly improved behavior , the effect increasing with fidelity to intervention , but the intervention proved more difficult to implement than anticipated .", "this study aimed to identify the barriers to and facilitators of implementation as experienced by those who delivered the intervention .", "semistructured interviews were conducted with @ intervention ward coordinators implementing the intervention .", "interview questions were based on the theoretical domains framework .", "text relating to each domain was scored according to whether it indicated low or high likelihood of implementation , and thematic analysis conducted .", "the lowest scoring domains were `` environmental context and resources , '' `` beliefs about capabilities , '' `` social influences , '' and `` emotion . ''", "lack of time and understaffing , perceived negativity from other staff members , and stress were identified as challenges to implementation .", "the highest scoring domains were `` behavioral regulation , '' `` motivation , '' `` skills , '' `` knowledge , '' and `` professional role . ''", "ward coordinators reported that they had the skills , understanding , and motivation to implement the intervention and spoke of consistency of tasks with existing roles .", "implementation might be improved by giving designated time for intervention tasks and ensuring that the ward coordinator role is allocated to staff for whom tasks are commensurate with existing professional roles ." ]
the feedback intervention trial was a national trial of an intervention to increase hand hygiene behavior in english and welsh hospitals . it significantly improved behavior , the effect increasing with fidelity to intervention , but the intervention proved more difficult to implement than anticipated . this study aimed to identify the barriers to and facilitators of implementation as experienced by those who delivered the intervention . semistructured interviews were conducted with @ intervention ward coordinators implementing the intervention . interview questions were based on the theoretical domains framework . text relating to each domain was scored according to whether it indicated low or high likelihood of implementation , and thematic analysis conducted . the lowest scoring domains were `` environmental context and resources , '' `` beliefs about capabilities , '' `` social influences , '' and `` emotion . '' lack of time and understaffing , perceived negativity from other staff members , and stress were identified as challenges to implementation . the highest scoring domains were `` behavioral regulation , '' `` motivation , '' `` skills , '' `` knowledge , '' and `` professional role . '' ward coordinators reported that they had the skills , understanding , and motivation to implement the intervention and spoke of consistency of tasks with existing roles . implementation might be improved by giving designated time for intervention tasks and ensuring that the ward coordinator role is allocated to staff for whom tasks are commensurate with existing professional roles .
24,656,784
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "up to @ % of patients with schizophrenia are non-adherent with antipsychotic medication .", "to establish the efficacy of adherence therapy ( at ) compared to treatment as usual ( tau ) in improving clinical outcomes in patients with schizophrenia following an acute exacerbation of illness .", "a parallel-group , single-blind , randomised controlled trial .", "fieldwork was conducted in thailand .", "patients received eight weekly sessions of at in addition to tau .", "the primary outcome was improvement in psychopathology ( measured using the positive and negative syndrome scale ( panss ) ) at @-week follow-up .", "secondary outcomes included patient attitudes towards medication , global functioning and side-effects .", "in total , @ inpatients with schizophrenia were recruited to the trial .", "at @-week follow-up , panss total scores improved in the at compared to the tau group by a mean of -@ points ( effect size = @ ) .", "the number needed to treat ( nnt ) was @ .", "there was no significant effect on patients ' attitudes towards treatment , functioning or medication side-effects .", "no treatment-related adverse effects were reported .", "at improves psychopathology in asian patients with schizophrenia following an acute exacerbation of illness ." ]
up to @ % of patients with schizophrenia are non-adherent with antipsychotic medication . to establish the efficacy of adherence therapy ( at ) compared to treatment as usual ( tau ) in improving clinical outcomes in patients with schizophrenia following an acute exacerbation of illness . a parallel-group , single-blind , randomised controlled trial . fieldwork was conducted in thailand . patients received eight weekly sessions of at in addition to tau . the primary outcome was improvement in psychopathology ( measured using the positive and negative syndrome scale ( panss ) ) at @-week follow-up . secondary outcomes included patient attitudes towards medication , global functioning and side-effects . in total , @ inpatients with schizophrenia were recruited to the trial . at @-week follow-up , panss total scores improved in the at compared to the tau group by a mean of -@ points ( effect size = @ ) . the number needed to treat ( nnt ) was @ . there was no significant effect on patients ' attitudes towards treatment , functioning or medication side-effects . no treatment-related adverse effects were reported . at improves psychopathology in asian patients with schizophrenia following an acute exacerbation of illness .
24,691,494
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to assess the long-term safety of the single-tablet combination of ibuprofen @mg and famotidine @ mg .", "a phase @b open-label study ( nct@ ) was conducted in @ adults requiring daily non-steroidal anti-inflammatory drug ( nsaid ) administration for @ months .", "the combination tablet of ibuprofen/famotidine was self-administered orally three times daily for up to @ consecutive weeks .", "adverse events ( aes ) were collected beginning at the first dose and continued through completion ( @ weeks ) .", "the severity of dyspepsia assessment ( soda ) questionnaire was completed by patients to assess tolerability .", "most patients ( @ % ) finished the trial , with @ % contributing data at @ months , and @ % withdrew due to adverse effects .", "overall and gastrointestinal ae discontinuation rates ( @ % and @ % , respectively ) were lower than that previously reported with ibuprofen @mg given alone .", "each of the soda subscale scores demonstrated improvement by week @ and improved statistically significantly at week @ and week @ .", "of the cardiovascular aes , hypertension was reported most frequently ( @/@ , @ % ) , with @ % determined to be drug related .", "twelve serious aes were reported by @ of @ ( @ % ) patients ; two were considered possibly related to the study medication ( unstable angina and gastric ulcer ) .", "there were no reports of serious gastrointestinal or cv complications .", "most aes were mild or moderate in severity and not considered drug related .", "these data , together with previously reported findings of a significant decrease in upper gastrointestinal endoscopic ulcer rate at @ months , support the overall safety , compliance , and tolerability of this single-tablet formulation ." ]
to assess the long-term safety of the single-tablet combination of ibuprofen @mg and famotidine @ mg . a phase @b open-label study ( nct@ ) was conducted in @ adults requiring daily non-steroidal anti-inflammatory drug ( nsaid ) administration for @ months . the combination tablet of ibuprofen/famotidine was self-administered orally three times daily for up to @ consecutive weeks . adverse events ( aes ) were collected beginning at the first dose and continued through completion ( @ weeks ) . the severity of dyspepsia assessment ( soda ) questionnaire was completed by patients to assess tolerability . most patients ( @ % ) finished the trial , with @ % contributing data at @ months , and @ % withdrew due to adverse effects . overall and gastrointestinal ae discontinuation rates ( @ % and @ % , respectively ) were lower than that previously reported with ibuprofen @mg given alone . each of the soda subscale scores demonstrated improvement by week @ and improved statistically significantly at week @ and week @ . of the cardiovascular aes , hypertension was reported most frequently ( @/@ , @ % ) , with @ % determined to be drug related . twelve serious aes were reported by @ of @ ( @ % ) patients ; two were considered possibly related to the study medication ( unstable angina and gastric ulcer ) . there were no reports of serious gastrointestinal or cv complications . most aes were mild or moderate in severity and not considered drug related . these data , together with previously reported findings of a significant decrease in upper gastrointestinal endoscopic ulcer rate at @ months , support the overall safety , compliance , and tolerability of this single-tablet formulation .
25,495,134
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to evaluate the effect of adjuvant chemotherapy ( act ) in locally advanced rectal cancer ( larc ) after neoadjuvant chemoradiation ( nact-rt ) .", "the study was funded by the italian national research council ( cnr ) .", "from september @ to january @ , @ patients with larc ( clinically t@-@ , any n ) treated with nact-rt and surgery , were randomized in two arms : follow-up ( arm a ) or @ cycles of act with @ fluorouracil ( @fu ) - folinic acid ( arm b ) .", "nact-rt consisted of @gy/@/ff concurrent with @fu ( @mg/sqm ) and folinic acid ( @mg/sqm ) on days @-@ and @-@ ; surgery was performed after @-@weeks .", "median follow up was @months .", "primary end point was overall survival ( os ) .", "@/@ patients were evaluable ( arm a @ , arm b @ ) ; @ % of arm a and @ % of arm b patients received the preoperative treatment as in the protocol ; @ patients of arm a ( @ % ) and @ of arm b ( @ % ) underwent a radical resection ; complete pathologic response and overall downstaging rates did not show any significant difference in the two arms .", "@/@ ( @ % ) patients in arm b , never started act .", "five year os and dfs did not show any significant difference in the two treatment arms .", "distant metastases occurred in @ patients ( @ % ) in arm a and in @ ( @ % ) in arm b.", "in patients with larc treated with nact-rt , the addition of act did not improve @year os and dfs and had no impact on the distant metastasis rate ." ]
to evaluate the effect of adjuvant chemotherapy ( act ) in locally advanced rectal cancer ( larc ) after neoadjuvant chemoradiation ( nact-rt ) . the study was funded by the italian national research council ( cnr ) . from september @ to january @ , @ patients with larc ( clinically t@-@ , any n ) treated with nact-rt and surgery , were randomized in two arms : follow-up ( arm a ) or @ cycles of act with @ fluorouracil ( @fu ) - folinic acid ( arm b ) . nact-rt consisted of @gy/@/ff concurrent with @fu ( @mg/sqm ) and folinic acid ( @mg/sqm ) on days @-@ and @-@ ; surgery was performed after @-@weeks . median follow up was @months . primary end point was overall survival ( os ) . @/@ patients were evaluable ( arm a @ , arm b @ ) ; @ % of arm a and @ % of arm b patients received the preoperative treatment as in the protocol ; @ patients of arm a ( @ % ) and @ of arm b ( @ % ) underwent a radical resection ; complete pathologic response and overall downstaging rates did not show any significant difference in the two arms . @/@ ( @ % ) patients in arm b , never started act . five year os and dfs did not show any significant difference in the two treatment arms . distant metastases occurred in @ patients ( @ % ) in arm a and in @ ( @ % ) in arm b. in patients with larc treated with nact-rt , the addition of act did not improve @year os and dfs and had no impact on the distant metastasis rate .
25,454,175
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "there is little evidence to inform the targeted treatment of individuals found early in the diabetes disease trajectory .", "to describe cardiovascular disease ( cvd ) risk profiles and treatment of individual cvd risk factors by modelled cvd risk at diagnosis ; changes in treatment , modelled cvd risk , and cvd risk factors in the @ years following diagnosis ; and how these are patterned by socioeconomic status .", "cohort analysis of a cluster-randomised trial ( addition-europe ) in general practices in denmark , england , and the netherlands .", "a total of @ individuals with screen-detected diabetes were divided into quartiles of modelled @-year cvd risk at diagnosis .", "changes in treatment , modelled cvd risk , and cvd risk factors were assessed at @ years .", "the largest reductions in risk factors and modelled cvd risk were seen in participants who were in the highest quartile of modelled risk at baseline , suggesting that treatment was offered appropriately .", "participants in the lowest quartile of risk at baseline had very similar levels of modelled cvd risk at @ years and showed the least variation in change in modelled risk .", "no association was found between socioeconomic status and changes in cvd risk factors , suggesting that treatment was equitable .", "diabetes management requires setting of individualised attainable targets .", "this analysis provides a reference point for patients , clinicians , and policymakers when considering goals for changes in risk factors early in the course of the disease that account for the diverse cardiometabolic profile present in individuals who are newly diagnosed with type @ diabetes ." ]
there is little evidence to inform the targeted treatment of individuals found early in the diabetes disease trajectory . to describe cardiovascular disease ( cvd ) risk profiles and treatment of individual cvd risk factors by modelled cvd risk at diagnosis ; changes in treatment , modelled cvd risk , and cvd risk factors in the @ years following diagnosis ; and how these are patterned by socioeconomic status . cohort analysis of a cluster-randomised trial ( addition-europe ) in general practices in denmark , england , and the netherlands . a total of @ individuals with screen-detected diabetes were divided into quartiles of modelled @-year cvd risk at diagnosis . changes in treatment , modelled cvd risk , and cvd risk factors were assessed at @ years . the largest reductions in risk factors and modelled cvd risk were seen in participants who were in the highest quartile of modelled risk at baseline , suggesting that treatment was offered appropriately . participants in the lowest quartile of risk at baseline had very similar levels of modelled cvd risk at @ years and showed the least variation in change in modelled risk . no association was found between socioeconomic status and changes in cvd risk factors , suggesting that treatment was equitable . diabetes management requires setting of individualised attainable targets . this analysis provides a reference point for patients , clinicians , and policymakers when considering goals for changes in risk factors early in the course of the disease that account for the diverse cardiometabolic profile present in individuals who are newly diagnosed with type @ diabetes .
24,686,885
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "chronic subclinical volume overload happens very frequently in hemodialysis patients and is associated directly with hypertension , increased arterial stiffness , left ventricular hypertrophy , and ultimately higher mortality .", "randomized controlled parallel-group trial .", "@ patients from one hemodialysis center , randomly assigned into @ groups .", "dry weight prescription using results derived from repeated @-month bioimpedance measurements to guide ultrafiltration for strict volume control ( bioimpedance group ; n = @ ) compared with clinical judgment without bioimpedance measures ( clinical-methods group ; n = @ ) for @ years .", "the primary outcome was all-cause mortality over @ years ( the duration of the intervention ) .", "secondary outcomes were change in relative arterial stiffness , fluid overload , and blood pressure ( bp ) over @ years .", "bioimpedance measurements were performed using a body composition monitor device .", "pulse wave velocity analysis was performed at baseline , @ years ( end of intervention ) , and @ years ( end of study ) .", "relative fluid overload and bp were assessed at @-month intervals .", "the unadjusted hr for all-cause death in the bioimpedance group ( vs the clinical-methods group ) was @ ( @ % ci , @-@ @ ; p = @ ) .", "after @ years , we found a greater decline in arterial stiffness , relative fluid overload , and systolic bp in the bioimpedance group than the clinical-methods group .", "between-group differences in change from baseline to the end of intervention were-@ @ ( @ % ci,-@ @ to @ ) m/s for pulse wave velocity ( p < @ ) , -@ % ( @ % ci,-@ @ % to-@ @ % ) for relative fluid overload ( p = @ ) , and-@ @ ( @ % ci,-@ @ to @ ) mmhg for systolic bp ( p = @ ) .", "echocardiography was not performed as cardiovascular assessment and the caregivers were not masked to the intervention .", "our study showed improvement in both surrogate and hard end points after strict volume control using bioimpedance to guide dry weight adjustment .", "these findings need to be confirmed in a larger trial ." ]
chronic subclinical volume overload happens very frequently in hemodialysis patients and is associated directly with hypertension , increased arterial stiffness , left ventricular hypertrophy , and ultimately higher mortality . randomized controlled parallel-group trial . @ patients from one hemodialysis center , randomly assigned into @ groups . dry weight prescription using results derived from repeated @-month bioimpedance measurements to guide ultrafiltration for strict volume control ( bioimpedance group ; n = @ ) compared with clinical judgment without bioimpedance measures ( clinical-methods group ; n = @ ) for @ years . the primary outcome was all-cause mortality over @ years ( the duration of the intervention ) . secondary outcomes were change in relative arterial stiffness , fluid overload , and blood pressure ( bp ) over @ years . bioimpedance measurements were performed using a body composition monitor device . pulse wave velocity analysis was performed at baseline , @ years ( end of intervention ) , and @ years ( end of study ) . relative fluid overload and bp were assessed at @-month intervals . the unadjusted hr for all-cause death in the bioimpedance group ( vs the clinical-methods group ) was @ ( @ % ci , @-@ @ ; p = @ ) . after @ years , we found a greater decline in arterial stiffness , relative fluid overload , and systolic bp in the bioimpedance group than the clinical-methods group . between-group differences in change from baseline to the end of intervention were-@ @ ( @ % ci,-@ @ to @ ) m/s for pulse wave velocity ( p < @ ) , -@ % ( @ % ci,-@ @ % to-@ @ % ) for relative fluid overload ( p = @ ) , and-@ @ ( @ % ci,-@ @ to @ ) mmhg for systolic bp ( p = @ ) . echocardiography was not performed as cardiovascular assessment and the caregivers were not masked to the intervention . our study showed improvement in both surrogate and hard end points after strict volume control using bioimpedance to guide dry weight adjustment . these findings need to be confirmed in a larger trial .
24,583,055
[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the efficacy of non-adjuvanted seasonal influenza vaccine in young children is considered to be suboptimal .", "this study compared the safety and immunogenicity profiles of mf@-adjuvanted , trivalent , influenza vaccine ( ativ ) and non-adjuvanted , trivalent , influenza vaccine ( tiv ) in guatemalan children ( n = @ ) between @ and < @ months of age .", "children received two doses of ativ or tiv administered four weeks apart .", "solicited adverse reactions were recorded for seven days after each vaccination .", "serious adverse events were recorded throughout the entire study period .", "antibody responses were assessed by hemagglutination inhibition ( hi ) assay at baseline , four weeks after administration of the first vaccine dose , and three weeks after administration of the second dose .", "both ativ and tiv were well tolerated , with similar rates of solicited reactions and adverse events observed in response to both vaccines .", "mf@-adjuvanted vaccine induced considerably higher antibody titers than did tiv .", "after two doses , the b strain-specific antibody response to tiv was insufficient to meet the center for biologics evaluation and research ( cber ) licensure criterion for seroprotection , whereas responses to the mf@-adjuvanted vaccine met the seroprotection criterion against all three strains .", "cross-reactive antibody responses to mf@-adjuvanted vaccine met the cber seroprotection criterion against all three strains after two doses ; b strain-specific heterologous responses to non-adjuvanted tiv were inadequate .", "the mf@-adjuvanted seasonal influenza vaccine was well-tolerated and highly immunogenic in children @ to < @ months of age , inducing seroprotective antibody titers against both the vaccine strains and antigenically distinct heterologous strains ." ]
the efficacy of non-adjuvanted seasonal influenza vaccine in young children is considered to be suboptimal . this study compared the safety and immunogenicity profiles of mf@-adjuvanted , trivalent , influenza vaccine ( ativ ) and non-adjuvanted , trivalent , influenza vaccine ( tiv ) in guatemalan children ( n = @ ) between @ and < @ months of age . children received two doses of ativ or tiv administered four weeks apart . solicited adverse reactions were recorded for seven days after each vaccination . serious adverse events were recorded throughout the entire study period . antibody responses were assessed by hemagglutination inhibition ( hi ) assay at baseline , four weeks after administration of the first vaccine dose , and three weeks after administration of the second dose . both ativ and tiv were well tolerated , with similar rates of solicited reactions and adverse events observed in response to both vaccines . mf@-adjuvanted vaccine induced considerably higher antibody titers than did tiv . after two doses , the b strain-specific antibody response to tiv was insufficient to meet the center for biologics evaluation and research ( cber ) licensure criterion for seroprotection , whereas responses to the mf@-adjuvanted vaccine met the seroprotection criterion against all three strains . cross-reactive antibody responses to mf@-adjuvanted vaccine met the cber seroprotection criterion against all three strains after two doses ; b strain-specific heterologous responses to non-adjuvanted tiv were inadequate . the mf@-adjuvanted seasonal influenza vaccine was well-tolerated and highly immunogenic in children @ to < @ months of age , inducing seroprotective antibody titers against both the vaccine strains and antigenically distinct heterologous strains .
25,212,080
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the authors compared the efficacy and tolerability of low and moderate dosages of extended-release quetiapine in adults with borderline personality disorder .", "ninety-five participants with dsm-iv borderline personality disorder were randomly assigned to receive @ mg/day of quetiapine ( the low-dosage group ; n = @ ) , @ mg/day of quetiapine ( the moderate-dosage group ; n = @ ) , or placebo ( n = @ ) .", "total score over time on the clinician-rated zanarini rating scale for borderline personality disorder ( `` zanarini scale '' ) was analyzed in a mixed-effects model accounting for informative dropout .", "participants in the low-dosage quetiapine group had significant improvement on the zanarini scale compared with those in the placebo group .", "time to response ( defined as a reduction of @ % or more on the zanarini scale total score ) was significantly shorter for both the low-dosage quetiapine group ( hazard ratio = @ , p = @ ) and the moderate-dosage quetiapine group ( hazard ratio = @ , p = @ ) than for the placebo group .", "among participants who completed the study , @ % in the low-dosage quetiapine group were rated as `` responders , '' compared with @ % in the moderate-dosage group and @ % in the placebo group .", "treatment-emergent adverse events included sedation , change in appetite , and dry mouth .", "the overall completion rate for the @-week double-blind treatment phase was @ % ( @ % for the low-dosage quetiapine group , @ % for the moderate-dosage quetiapine group , and @ % for the placebo group ) .", "participants who experienced sedation were more likely to drop out .", "participants treated with @ mg/day of quetiapine had a significant reduction in the severity of borderline personality disorder symptoms compared with those who received placebo .", "adverse events were more likely in participants taking @ mg/day of quetiapine ." ]
the authors compared the efficacy and tolerability of low and moderate dosages of extended-release quetiapine in adults with borderline personality disorder . ninety-five participants with dsm-iv borderline personality disorder were randomly assigned to receive @ mg/day of quetiapine ( the low-dosage group ; n = @ ) , @ mg/day of quetiapine ( the moderate-dosage group ; n = @ ) , or placebo ( n = @ ) . total score over time on the clinician-rated zanarini rating scale for borderline personality disorder ( `` zanarini scale '' ) was analyzed in a mixed-effects model accounting for informative dropout . participants in the low-dosage quetiapine group had significant improvement on the zanarini scale compared with those in the placebo group . time to response ( defined as a reduction of @ % or more on the zanarini scale total score ) was significantly shorter for both the low-dosage quetiapine group ( hazard ratio = @ , p = @ ) and the moderate-dosage quetiapine group ( hazard ratio = @ , p = @ ) than for the placebo group . among participants who completed the study , @ % in the low-dosage quetiapine group were rated as `` responders , '' compared with @ % in the moderate-dosage group and @ % in the placebo group . treatment-emergent adverse events included sedation , change in appetite , and dry mouth . the overall completion rate for the @-week double-blind treatment phase was @ % ( @ % for the low-dosage quetiapine group , @ % for the moderate-dosage quetiapine group , and @ % for the placebo group ) . participants who experienced sedation were more likely to drop out . participants treated with @ mg/day of quetiapine had a significant reduction in the severity of borderline personality disorder symptoms compared with those who received placebo . adverse events were more likely in participants taking @ mg/day of quetiapine .
24,968,985
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "this study evaluates if there is any benefit of adding epinephrine to lidocaine in patients undergoing diagnostic rigid nasal endoscopy .", "a prospective , randomized , double-blinded study was performed .", "seventy patients were randomized to receive either @ % lidocaine or @ % lidocaine with @ % epinephrine before rigid nasal endoscopy examination .", "patients were asked to report the intensity of pain and discomfort they experienced using visual analog scale .", "an endoscopist recorded the ease to perform the procedure using the same scale .", "intranasal structures visualized were also reported .", "there were no significant differences in pain , discomfort or ease of exam , or in the percentage of visualized nasal structures between the two groups .", "in the whole series , there were no significant differences in the studied variables based on gender or indication to perform endoscopy .", "adding epinephrine to lidocaine has no advantages in patients undergoing diagnostic rigid nasal endoscopy ." ]
this study evaluates if there is any benefit of adding epinephrine to lidocaine in patients undergoing diagnostic rigid nasal endoscopy . a prospective , randomized , double-blinded study was performed . seventy patients were randomized to receive either @ % lidocaine or @ % lidocaine with @ % epinephrine before rigid nasal endoscopy examination . patients were asked to report the intensity of pain and discomfort they experienced using visual analog scale . an endoscopist recorded the ease to perform the procedure using the same scale . intranasal structures visualized were also reported . there were no significant differences in pain , discomfort or ease of exam , or in the percentage of visualized nasal structures between the two groups . in the whole series , there were no significant differences in the studied variables based on gender or indication to perform endoscopy . adding epinephrine to lidocaine has no advantages in patients undergoing diagnostic rigid nasal endoscopy .
25,514,490
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to compare the effects of a chinese herbal suppository ( jianpi suppository ) and western medicine ( mesalazine ) on hemorheology and cd@p in patients with ulcerative colitis ( uc ) .", "in a randomized trial , @ mild to moderate uc patients were randomly divided into two equal groups .", "the jianpi suppository group used chinese herbal suppository rectally , while the mesalazine group was treated with mesalazine tablets orally .", "two @-day courses of treatment were carried out in both groups .", "changes in the hemorheology and cd@p indices in patients were observed .", "the hemorheology and cd@p indices in the jianpi suppository group decreased significantly more than those of the mesalazine group .", "jianpi suppository is effective in improving the hypercoagulability of uc patients , and therefore may be worth using in clinical practice ." ]
to compare the effects of a chinese herbal suppository ( jianpi suppository ) and western medicine ( mesalazine ) on hemorheology and cd@p in patients with ulcerative colitis ( uc ) . in a randomized trial , @ mild to moderate uc patients were randomly divided into two equal groups . the jianpi suppository group used chinese herbal suppository rectally , while the mesalazine group was treated with mesalazine tablets orally . two @-day courses of treatment were carried out in both groups . changes in the hemorheology and cd@p indices in patients were observed . the hemorheology and cd@p indices in the jianpi suppository group decreased significantly more than those of the mesalazine group . jianpi suppository is effective in improving the hypercoagulability of uc patients , and therefore may be worth using in clinical practice .
24,783,925
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS" ]
[ "this study assessed the validity and usefulness of the bayley scales of infant and toddler development , third edition ( bayley-iii ) low motor/vision accommodated version .", "accommodations are adaptations to minimize impairment bias , without altering what the test measures .", "of the items , @ % have low motor accommodations like enlarged materials ; @ % have low vision accommodations .", "using a within-subject design , we tested @ children with the accommodated and standard bayley-iii , in a randomly counterbalanced order .", "the children had motor and/or visual impairment and a chronological age between @ and @ months .", "the test administrators completed an evaluation form .", "a subgroup of children benefited from the accommodations ; @ children obtained a large raw score difference .", "test administrators considered the accommodations as practical , and advantageous for most children .", "the low motor/vision accommodated version seems to validly assess the development of this population .", "future , larger-scale research should study whether the accommodations improve the construct validity of the bayley-iii ." ]
this study assessed the validity and usefulness of the bayley scales of infant and toddler development , third edition ( bayley-iii ) low motor/vision accommodated version . accommodations are adaptations to minimize impairment bias , without altering what the test measures . of the items , @ % have low motor accommodations like enlarged materials ; @ % have low vision accommodations . using a within-subject design , we tested @ children with the accommodated and standard bayley-iii , in a randomly counterbalanced order . the children had motor and/or visual impairment and a chronological age between @ and @ months . the test administrators completed an evaluation form . a subgroup of children benefited from the accommodations ; @ children obtained a large raw score difference . test administrators considered the accommodations as practical , and advantageous for most children . the low motor/vision accommodated version seems to validly assess the development of this population . future , larger-scale research should study whether the accommodations improve the construct validity of the bayley-iii .
24,356,320
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "fibroblast growth factor @ ( fgf@ ) and klotho are associated with vascular calcification and cardiovascular disease in dialysis patients .", "sevelamer has been shown to reduce progression of vascular calcification .", "this study aimed to determine the long-term effect of sevelamer treatment on serum fgf@ and klotho levels in chronic haemodialysis ( hd ) patients .", "in the post-hoc analysis , we measured serum fgf@ , klotho and other biochemical factors ( ca , p , i-pth , hscrp , ldl-c ) in @ haemodialysis patients , who completed a @-week , open-label , controlled randomized parallel-group study .", "twenty-three patients received sevelamer and @ patients received calcium carbonate .", "after @-week sevelamer treatment , there were significant changes with lower ldl-c ( from @ to @ mmol/l , p = @ ) , lower fgf@ ( from @ ( @ ) to @ ( @ ) , p = @ ) and higher s-klotho levels ( from @ ( @ ) to @ ( @ ) pg/ml , p = @ ) .", "in calcium carbonate group , there were no significant changes of ldl-c and fgf@ , but with a borderline significant increase of s-klotho level ( from @ ( @ ) to @ ( @ ) pg/ml , p = @ ) .", "multivariate analysis showed that fgf@ decrement was associated with sevelamer treatment ( = -@ , p = @ ) , change of serum phosphate ( = @ , p = @ ) and calcium levels ( = @ , p = @ ) .", "the increase of serum klotho was associated with the decrease of serum phosphate ( = @ , p = @ ) .", "maintenance hd patients had lower serum fgf@ levels , accompanied with significantly increased serum klotho levels , after @-week sevelamer treatment .", "the fgf@ decrement was associated with sevelamer use , the change of serum phosphate and calcium levels .", "the serum klotho increment was proportional to the phosphate-lowering power of the binders ." ]
fibroblast growth factor @ ( fgf@ ) and klotho are associated with vascular calcification and cardiovascular disease in dialysis patients . sevelamer has been shown to reduce progression of vascular calcification . this study aimed to determine the long-term effect of sevelamer treatment on serum fgf@ and klotho levels in chronic haemodialysis ( hd ) patients . in the post-hoc analysis , we measured serum fgf@ , klotho and other biochemical factors ( ca , p , i-pth , hscrp , ldl-c ) in @ haemodialysis patients , who completed a @-week , open-label , controlled randomized parallel-group study . twenty-three patients received sevelamer and @ patients received calcium carbonate . after @-week sevelamer treatment , there were significant changes with lower ldl-c ( from @ to @ mmol/l , p = @ ) , lower fgf@ ( from @ ( @ ) to @ ( @ ) , p = @ ) and higher s-klotho levels ( from @ ( @ ) to @ ( @ ) pg/ml , p = @ ) . in calcium carbonate group , there were no significant changes of ldl-c and fgf@ , but with a borderline significant increase of s-klotho level ( from @ ( @ ) to @ ( @ ) pg/ml , p = @ ) . multivariate analysis showed that fgf@ decrement was associated with sevelamer treatment ( = -@ , p = @ ) , change of serum phosphate ( = @ , p = @ ) and calcium levels ( = @ , p = @ ) . the increase of serum klotho was associated with the decrease of serum phosphate ( = @ , p = @ ) . maintenance hd patients had lower serum fgf@ levels , accompanied with significantly increased serum klotho levels , after @-week sevelamer treatment . the fgf@ decrement was associated with sevelamer use , the change of serum phosphate and calcium levels . the serum klotho increment was proportional to the phosphate-lowering power of the binders .
25,113,414
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to compare the efficacy and tolerability of monotherapy with phenazepam to complex treatment with the peptide preparation selank and phenazepam in patients with anxiety disorders .", "authors explored the anxiolytic effect and tolerability of monotherapy with phenazepam ( @ patients ) and complex treatment with selank and phenazepam ( @ patients ) in anxiety-phobic , hypochondriac and somatoform disorders ( icd-@ items f@-@ , f@-@ , f@-@ ) .", "therapeutic effect was assessed clinically and with hdrs , cgi and spilberger scales .", "tolerability was evaluated using the uku scale .", "stroop test and verbal fluency test were used .", "quality of life was assessed with the sf-@ .", "the positive effect of phenazepam was achieved earlier in the optimization of treatment with selank on hdrs .", "the combined treatment decreased the level of undesirable side-effects of phenazepam ( attention and memory impairment , asthenia , sedation , increase in sleep duration , sexual disturbances , emotional indifference and orthostatism ) during the course of treatment and after the tranquilizer withdrawal .", "taken together , the therapeutic efficacy and reduction of side-effects had a positive impact on the quality-of-life of the patients treated with selank as add-on to phenazepam .", "the results extend therapeutic possibilities of treatment of anxietyspectrum disorders with the combination of benzodiazepine tranquilizers and selank ." ]
to compare the efficacy and tolerability of monotherapy with phenazepam to complex treatment with the peptide preparation selank and phenazepam in patients with anxiety disorders . authors explored the anxiolytic effect and tolerability of monotherapy with phenazepam ( @ patients ) and complex treatment with selank and phenazepam ( @ patients ) in anxiety-phobic , hypochondriac and somatoform disorders ( icd-@ items f@-@ , f@-@ , f@-@ ) . therapeutic effect was assessed clinically and with hdrs , cgi and spilberger scales . tolerability was evaluated using the uku scale . stroop test and verbal fluency test were used . quality of life was assessed with the sf-@ . the positive effect of phenazepam was achieved earlier in the optimization of treatment with selank on hdrs . the combined treatment decreased the level of undesirable side-effects of phenazepam ( attention and memory impairment , asthenia , sedation , increase in sleep duration , sexual disturbances , emotional indifference and orthostatism ) during the course of treatment and after the tranquilizer withdrawal . taken together , the therapeutic efficacy and reduction of side-effects had a positive impact on the quality-of-life of the patients treated with selank as add-on to phenazepam . the results extend therapeutic possibilities of treatment of anxietyspectrum disorders with the combination of benzodiazepine tranquilizers and selank .
26,356,395
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "this study aimed to evaluate the long-term effects on glycemic control of a diabetes care program focusing on case management and to discuss challenges in the quality of diabetes care in taiwan .", "we randomized @,@ study subjects recruited from the diabetes management through an integrated delivery system project in @-@ into intervention ( n = @ from @ clinics ) and control ( n = @ from @ clinics ) groups .", "the quarterly self-care and nutrition-education program in the intervention group was delivered by case managers , and standard care was provided to the control group .", "the intervention program was conducted during @-@ .", "a multivariate mixed model analysis was used to assess the @-year intervention effects on glycemic control .", "glycated hemoglobin ( hba@c ) level in the intervention group ( especially for those with a baseline hba@c level of @-@ % and > @ % ) was significantly lower than that in the control group @ months after recruitment and remained lower through the subsequent three intervention years .", "the current findings provide evidence that case management provided in the pay-for-performance ( p@p ) diabetes care program in taiwan was effective at improving glycemic control for at least @ years .", "however , previous research indicated poverty is associated with not only higher diabetes incidence but also inequality of diabetes care in taiwan despite universal health coverage .", "those with a more severe condition were less likely to be enrolled in the p@p diabetes care program .", "additional cost-effectiveness studies and more health policy reforms are needed to optimize diabetes care in taiwan ." ]
this study aimed to evaluate the long-term effects on glycemic control of a diabetes care program focusing on case management and to discuss challenges in the quality of diabetes care in taiwan . we randomized @,@ study subjects recruited from the diabetes management through an integrated delivery system project in @-@ into intervention ( n = @ from @ clinics ) and control ( n = @ from @ clinics ) groups . the quarterly self-care and nutrition-education program in the intervention group was delivered by case managers , and standard care was provided to the control group . the intervention program was conducted during @-@ . a multivariate mixed model analysis was used to assess the @-year intervention effects on glycemic control . glycated hemoglobin ( hba@c ) level in the intervention group ( especially for those with a baseline hba@c level of @-@ % and > @ % ) was significantly lower than that in the control group @ months after recruitment and remained lower through the subsequent three intervention years . the current findings provide evidence that case management provided in the pay-for-performance ( p@p ) diabetes care program in taiwan was effective at improving glycemic control for at least @ years . however , previous research indicated poverty is associated with not only higher diabetes incidence but also inequality of diabetes care in taiwan despite universal health coverage . those with a more severe condition were less likely to be enrolled in the p@p diabetes care program . additional cost-effectiveness studies and more health policy reforms are needed to optimize diabetes care in taiwan .
25,550,062
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the goal of this study was to assess the effects of training primary care providers ( pcps ) to use motivational interviewing ( mi ) when treating depressed patients on providers ' mi performance and patients ' expressions of interest in depression treatment ( `` change talk '' ) and short-term treatment adherence .", "this was a cluster randomized trial in urban primary care clinics ( @ intervention , @ control ) .", "we recruited @ pcps ( @ intervention , @ control ) and @ english-speaking patients with newly diagnosed depression ( @ intervention , @ control ) .", "mi training included a baseline and up to @ refresher classroom trainings , along with feedback on audiotaped patient encounters .", "we report summary measures of technical ( rate of mi-consistent statements per @ minutes during encounters ) and relational ( global rating of `` mi spirit '' ) mi performance , the association between mi performance and number of mi trainings attended ( @ , @ , @ , or @ ) , and rates of patient change talk regarding depression treatments ( physical activity , antidepressant medication ) .", "we report pcp use of physical activity recommendations and antidepressant prescriptions and patients ' short-term physical activity level and prescription fill rates .", "use of mi-consistent statements was @ % higher for mi-trained versus control pcps ( p = @ ) .", "pcps attending all @ mi trainings ( n = @ ) had @ % higher use of mi-consistent statements ( p < @ ) and were over @ times more likely to show beginning proficiency in mi spirit ( p = @ ) relative to control pcps .", "although pcps ' use of physical activity recommendations and antidepressant prescriptions was not significantly different by randomization arm , patients seen by mi-trained pcps had more frequent change talk ( p = @ ) .", "patients of mi-trained pcps also expressed change talk about physical activity @ times more frequently ( p = @ ) and reported more physical activity ( @ vs @ days in the week after the visit ; p = @ ) than their counterparts visiting untrained pcps .", "change talk about antidepressant medication and fill rates were similar by randomization arm ( p > @ for both ) .", "mi training resulted in improved mi performance , more depression-related patient change talk , and better short-term adherence ." ]
the goal of this study was to assess the effects of training primary care providers ( pcps ) to use motivational interviewing ( mi ) when treating depressed patients on providers ' mi performance and patients ' expressions of interest in depression treatment ( `` change talk '' ) and short-term treatment adherence . this was a cluster randomized trial in urban primary care clinics ( @ intervention , @ control ) . we recruited @ pcps ( @ intervention , @ control ) and @ english-speaking patients with newly diagnosed depression ( @ intervention , @ control ) . mi training included a baseline and up to @ refresher classroom trainings , along with feedback on audiotaped patient encounters . we report summary measures of technical ( rate of mi-consistent statements per @ minutes during encounters ) and relational ( global rating of `` mi spirit '' ) mi performance , the association between mi performance and number of mi trainings attended ( @ , @ , @ , or @ ) , and rates of patient change talk regarding depression treatments ( physical activity , antidepressant medication ) . we report pcp use of physical activity recommendations and antidepressant prescriptions and patients ' short-term physical activity level and prescription fill rates . use of mi-consistent statements was @ % higher for mi-trained versus control pcps ( p = @ ) . pcps attending all @ mi trainings ( n = @ ) had @ % higher use of mi-consistent statements ( p < @ ) and were over @ times more likely to show beginning proficiency in mi spirit ( p = @ ) relative to control pcps . although pcps ' use of physical activity recommendations and antidepressant prescriptions was not significantly different by randomization arm , patients seen by mi-trained pcps had more frequent change talk ( p = @ ) . patients of mi-trained pcps also expressed change talk about physical activity @ times more frequently ( p = @ ) and reported more physical activity ( @ vs @ days in the week after the visit ; p = @ ) than their counterparts visiting untrained pcps . change talk about antidepressant medication and fill rates were similar by randomization arm ( p > @ for both ) . mi training resulted in improved mi performance , more depression-related patient change talk , and better short-term adherence .
25,201,932
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "radical cystectomy ( rc ) for bladder cancer is frequently associated with delayed gastrointestinal ( gi ) recovery that prolongs hospital length of stay ( los ) .", "to assess the efficacy of alvimopan to accelerate gi recovery after rc .", "we conducted a randomized double-blind placebo-controlled trial in patients undergoing rc and receiving postoperative intravenous patient-controlled opioid analgesics .", "oral alvimopan @ mg ( maximum : @ inpatient doses ) versus placebo .", "the two-component primary end point was time to upper ( first tolerance of solid food ) and lower ( first bowel movement ) gi recovery ( gi-@ ) .", "time to discharge order written , postoperative los , postoperative ileus ( poi ) - related morbidity , opioid consumption , and adverse events ( aes ) were evaluated .", "an independent adjudication of cardiovascular aes was performed .", "patients were randomized to alvimopan ( n = @ ) or placebo ( n = @ ) ; @ patients were included in the modified intention-to-treat population .", "the alvimopan cohort experienced quicker gi-@ recovery ( @ vs @ d ; hazard ratio : @ ; p < @ ) , shorter mean los ( @ vs @ d ; p = @ ) , and fewer episodes of poi-related morbidity ( @ % vs @ % ; p < @ ) .", "the incidence of opioid consumption and aes or serious aes ( saes ) was comparable except for poi , which was lower in the alvimopan group ( aes : @ % vs @ % ; saes : @ % vs @ % , respectively ) .", "cardiovascular aes occurred in @ % ( alvimopan ) and @ % ( placebo ) of patients ( p = @ ) .", "generalizability may be limited due to the exclusion of epidural analgesia and the inclusion of mostly high-volume centers utilizing open laparotomy .", "alvimopan is a useful addition to a standardized care pathway in patients undergoing rc by accelerating gi recovery and shortening los , with a safety profile similar to placebo .", "this study examined the effects of alvimopan on bowel recovery in patients undergoing radical cystectomy for bladder cancer .", "patients receiving alvimopan experienced quicker bowel recovery and had a shorter hospital stay compared with those who received placebo , with comparable safety .", "clinicaltrials.gov identifier nct@ ." ]
radical cystectomy ( rc ) for bladder cancer is frequently associated with delayed gastrointestinal ( gi ) recovery that prolongs hospital length of stay ( los ) . to assess the efficacy of alvimopan to accelerate gi recovery after rc . we conducted a randomized double-blind placebo-controlled trial in patients undergoing rc and receiving postoperative intravenous patient-controlled opioid analgesics . oral alvimopan @ mg ( maximum : @ inpatient doses ) versus placebo . the two-component primary end point was time to upper ( first tolerance of solid food ) and lower ( first bowel movement ) gi recovery ( gi-@ ) . time to discharge order written , postoperative los , postoperative ileus ( poi ) - related morbidity , opioid consumption , and adverse events ( aes ) were evaluated . an independent adjudication of cardiovascular aes was performed . patients were randomized to alvimopan ( n = @ ) or placebo ( n = @ ) ; @ patients were included in the modified intention-to-treat population . the alvimopan cohort experienced quicker gi-@ recovery ( @ vs @ d ; hazard ratio : @ ; p < @ ) , shorter mean los ( @ vs @ d ; p = @ ) , and fewer episodes of poi-related morbidity ( @ % vs @ % ; p < @ ) . the incidence of opioid consumption and aes or serious aes ( saes ) was comparable except for poi , which was lower in the alvimopan group ( aes : @ % vs @ % ; saes : @ % vs @ % , respectively ) . cardiovascular aes occurred in @ % ( alvimopan ) and @ % ( placebo ) of patients ( p = @ ) . generalizability may be limited due to the exclusion of epidural analgesia and the inclusion of mostly high-volume centers utilizing open laparotomy . alvimopan is a useful addition to a standardized care pathway in patients undergoing rc by accelerating gi recovery and shortening los , with a safety profile similar to placebo . this study examined the effects of alvimopan on bowel recovery in patients undergoing radical cystectomy for bladder cancer . patients receiving alvimopan experienced quicker bowel recovery and had a shorter hospital stay compared with those who received placebo , with comparable safety . clinicaltrials.gov identifier nct@ .
24,630,419
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "RESULTS", "RESULTS", "BACKGROUND" ]
[ "to evaluate the effect of @ ) patient values as expressed by family members and @ ) a requirement to document patients ' functional prognosis on intensivists ' intention to discuss withdrawal of life support in a hypothetical family meeting .", "a three-armed , randomized trial .", "one hundred seventy-nine u.s. hospitals with training programs in critical care accredited by the accreditation council for graduate medical education .", "six hundred thirty intensivists recruited via e-mail invitation from a database of @,@ eligible academic intensivists .", "each intensivist was randomized to review @ , online , clinical scenarios with a range of illness severities involving a hypothetical patient ( mrs. x ) .", "in control-group scenarios , the patient did not want continued life support without a reasonable chance of independent living .", "in the first experimental arm , the patient wanted life support regardless of functional outcome .", "in the second experimental arm , patient values were identical to the control group , but intensivists were required to record the patient 's estimated @-month functional prognosis .", "response to the question : `` would you bring up the possibility of withdrawing life support with mrs. x 's family ? ''", "answered using a five-point likert scale .", "there was no effect of patient values on whether intensivists intended to discuss withdrawal of life support ( p = @ ) , but intensivists randomized to record functional prognosis were @ % more likely ( @ % ci , @-@ % ) to discuss withdrawal .", "in this national , scenario-based , randomized trial , patient values had no effect on intensivists ' decisions to discuss withdrawal of life support with family .", "however , requiring intensivists to record patients ' estimated @-month functional outcome substantially increased their intention to discuss withdrawal ." ]
to evaluate the effect of @ ) patient values as expressed by family members and @ ) a requirement to document patients ' functional prognosis on intensivists ' intention to discuss withdrawal of life support in a hypothetical family meeting . a three-armed , randomized trial . one hundred seventy-nine u.s. hospitals with training programs in critical care accredited by the accreditation council for graduate medical education . six hundred thirty intensivists recruited via e-mail invitation from a database of @,@ eligible academic intensivists . each intensivist was randomized to review @ , online , clinical scenarios with a range of illness severities involving a hypothetical patient ( mrs. x ) . in control-group scenarios , the patient did not want continued life support without a reasonable chance of independent living . in the first experimental arm , the patient wanted life support regardless of functional outcome . in the second experimental arm , patient values were identical to the control group , but intensivists were required to record the patient 's estimated @-month functional prognosis . response to the question : `` would you bring up the possibility of withdrawing life support with mrs. x 's family ? '' answered using a five-point likert scale . there was no effect of patient values on whether intensivists intended to discuss withdrawal of life support ( p = @ ) , but intensivists randomized to record functional prognosis were @ % more likely ( @ % ci , @-@ % ) to discuss withdrawal . in this national , scenario-based , randomized trial , patient values had no effect on intensivists ' decisions to discuss withdrawal of life support with family . however , requiring intensivists to record patients ' estimated @-month functional outcome substantially increased their intention to discuss withdrawal .
24,584,065
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to determine women 's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour .", "multicentre randomised controlled equivalence trial .", "@ hospitals in the netherlands .", "women with an intermediate to high obstetric risk with an intention to deliver vaginally .", "to exclude a clinically relevant difference in satisfaction with pain relief of more than @ % , we needed to include @ women .", "because of missing values for satisfaction this number was increased to @ before any analysis .", "we used multiple imputation to correct for missing data .", "before the onset of active labour consenting women were randomised to a pain relief strategy with patient controlled remifentanil or epidural analgesia if they requested pain relief during labour .", "primary outcome was satisfaction with pain relief , measured hourly on a visual analogue scale and expressed as area under the curve ( auc ) , thus providing a time weighted measure of total satisfaction with pain relief .", "a higher auc represents higher satisfaction with pain relief .", "secondary outcomes were pain intensity scores , mode of delivery , and maternal and neonatal outcomes .", "analysis was done by intention to treat .", "the study was defined as an equivalence study for the primary outcome .", "@ women were randomised , of whom @ were allocated to patient controlled remifentanil and @ to epidural analgesia .", "baseline characteristics were comparable .", "pain relief was ultimately used in @ % ( @/@ ) in the remifentanil group and @ % ( @/@ ) in the epidural analgesia group ( relative risk @ , @ % confidence interval @ to @ ) .", "cross over occurred in @ % ( @/@ ) and @ % ( @/@ ) of women , respectively .", "of women primarily treated with remifentanil , @ % ( @/@ ) converted to epidural analgesia , while in women primarily treated with epidural analgesia @ % ( @/@ ) converted to remifentanil .", "the area under the curve for total satisfaction with pain relief was @ in the remifentanil group versus @ in the epidural analgesia group ( mean difference -@ , @ % confidence interval -@ to @ ) .", "for who actually received pain relief the area under the curve for satisfaction with pain relief after the start of pain relief was @ in the remifentanil group versus @ in the epidural analgesia group ( mean difference -@ , -@ to -@ ) .", "the rate of caesarean section was @ % in both groups .", "oxygen saturation was significantly lower ( spo@ < @ % ) in women who used remifentanil ( relative risk @ , @ to @ ) .", "maternal and neonatal outcomes were comparable between both groups .", "in women in labour , patient controlled analgesia with remifentanil is not equivalent to epidural analgesia with respect to scores on satisfaction with pain relief .", "satisfaction with pain relief was significantly higher in women who were allocated to and received epidural analgesia .", "netherlands trial register ntr@ ." ]
to determine women 's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour . multicentre randomised controlled equivalence trial . @ hospitals in the netherlands . women with an intermediate to high obstetric risk with an intention to deliver vaginally . to exclude a clinically relevant difference in satisfaction with pain relief of more than @ % , we needed to include @ women . because of missing values for satisfaction this number was increased to @ before any analysis . we used multiple imputation to correct for missing data . before the onset of active labour consenting women were randomised to a pain relief strategy with patient controlled remifentanil or epidural analgesia if they requested pain relief during labour . primary outcome was satisfaction with pain relief , measured hourly on a visual analogue scale and expressed as area under the curve ( auc ) , thus providing a time weighted measure of total satisfaction with pain relief . a higher auc represents higher satisfaction with pain relief . secondary outcomes were pain intensity scores , mode of delivery , and maternal and neonatal outcomes . analysis was done by intention to treat . the study was defined as an equivalence study for the primary outcome . @ women were randomised , of whom @ were allocated to patient controlled remifentanil and @ to epidural analgesia . baseline characteristics were comparable . pain relief was ultimately used in @ % ( @/@ ) in the remifentanil group and @ % ( @/@ ) in the epidural analgesia group ( relative risk @ , @ % confidence interval @ to @ ) . cross over occurred in @ % ( @/@ ) and @ % ( @/@ ) of women , respectively . of women primarily treated with remifentanil , @ % ( @/@ ) converted to epidural analgesia , while in women primarily treated with epidural analgesia @ % ( @/@ ) converted to remifentanil . the area under the curve for total satisfaction with pain relief was @ in the remifentanil group versus @ in the epidural analgesia group ( mean difference -@ , @ % confidence interval -@ to @ ) . for who actually received pain relief the area under the curve for satisfaction with pain relief after the start of pain relief was @ in the remifentanil group versus @ in the epidural analgesia group ( mean difference -@ , -@ to -@ ) . the rate of caesarean section was @ % in both groups . oxygen saturation was significantly lower ( spo@ < @ % ) in women who used remifentanil ( relative risk @ , @ to @ ) . maternal and neonatal outcomes were comparable between both groups . in women in labour , patient controlled analgesia with remifentanil is not equivalent to epidural analgesia with respect to scores on satisfaction with pain relief . satisfaction with pain relief was significantly higher in women who were allocated to and received epidural analgesia . netherlands trial register ntr@ .
25,713,015
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "ttp@ , an antagonist at the receptor for advanced glycation end products , was evaluated as a potential treatment for patients with mild-to-moderate alzheimer 's disease ( ad ) .", "a previous report describes decreased decline in adas-cog ( delta = @ , p = @ at @ months , ancova with multiple imputation ) , relative to placebo , following a @ mg/day dose of ttp@ .", "acute , reversible cognitive worsening was seen with a @ mg/day dose .", "the present study further evaluates the efficacy of ttp@ by subgroup analyses based on disease severity and concentration effect analysis .", "@ patients were randomized to one of two oral ttp@ doses ( @ mg for @ days followed by @ mg/day ; @ mg for @ days followed by @ mg/day ) or placebo for @ months .", "pre-specified primary analysis , using an itt population , was on the adas-cog@ .", "secondary analyses included as a key secondary variable the clinical dementia rating-sum of boxes ( cdr-sb ) , and another secondary variable of the adcs-adl .", "on-treatment analysis demonstrated numerical differences favoring @ mg/day over placebo , with nominal significance at month @ ( delta = @ , p = @ ) .", "patients with mild ad , whether defined by mmse or adas-cog , demonstrated significant differences favoring @ mg/day on adas-cog and trends on cdr-sb and adcs-adl at month @ .", "ttp@ plasma concentrations of @-@ @ ng/ml were associated with a decreased decline in adas-cog over time compared to placebo .", "worsening on the adas-cog relative to placebo was evident at @-@ @ ng/ml .", "results of these analyses support further investigation of @ mg/day in future phase @ trials in patients with mild ad ." ]
ttp@ , an antagonist at the receptor for advanced glycation end products , was evaluated as a potential treatment for patients with mild-to-moderate alzheimer 's disease ( ad ) . a previous report describes decreased decline in adas-cog ( delta = @ , p = @ at @ months , ancova with multiple imputation ) , relative to placebo , following a @ mg/day dose of ttp@ . acute , reversible cognitive worsening was seen with a @ mg/day dose . the present study further evaluates the efficacy of ttp@ by subgroup analyses based on disease severity and concentration effect analysis . @ patients were randomized to one of two oral ttp@ doses ( @ mg for @ days followed by @ mg/day ; @ mg for @ days followed by @ mg/day ) or placebo for @ months . pre-specified primary analysis , using an itt population , was on the adas-cog@ . secondary analyses included as a key secondary variable the clinical dementia rating-sum of boxes ( cdr-sb ) , and another secondary variable of the adcs-adl . on-treatment analysis demonstrated numerical differences favoring @ mg/day over placebo , with nominal significance at month @ ( delta = @ , p = @ ) . patients with mild ad , whether defined by mmse or adas-cog , demonstrated significant differences favoring @ mg/day on adas-cog and trends on cdr-sb and adcs-adl at month @ . ttp@ plasma concentrations of @-@ @ ng/ml were associated with a decreased decline in adas-cog over time compared to placebo . worsening on the adas-cog relative to placebo was evident at @-@ @ ng/ml . results of these analyses support further investigation of @ mg/day in future phase @ trials in patients with mild ad .
24,423,155
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the sibutramine cardiovascular outcomes ( scout ) trial showed a significantly increased relative risk of nonfatal cardiovascular events , but not mortality , in overweight and obese subjects receiving long-term sibutramine treatment with diet and exercise .", "we examined the relationship between early changes ( both increases and decreases ) in body weight and blood pressure , and the impact of these changes on subsequent cardiovascular outcome events .", "a total of @ male and female subjects , aged @ years or older , with a body mass index of @-@kgm ( -@ ) were included in this current subanalysis of the scout trial .", "subjects were required to have a history of cardiovascular disease and/or type @ diabetes mellitus with at least one cardiovascular risk factor ( hypertension , dyslipidemia , current smoking or diabetic nephropathy ) to assess cardiovascular outcomes .", "post hoc subgroup analyses of weight change ( categories ) and blood pressure were performed overall and by treatment group ( @-week sibutramine followed by randomized placebo or continued sibutramine ) .", "the primary outcome event ( poe ) was a composite of nonfatal myocardial infarction , nonfatal stroke , resuscitated cardiac arrest or cardiovascular death .", "time-to-event analyses of the poe were performed using cox regression models with factors for treatment , subgroups and interactions .", "during the initial @-week sibutramine treatment period , systolic blood pressure decreased progressively with increasing weight loss in hypertensive subjects ( -@ mmhg with < @kg weight loss to -@ mmhg with @kg weight loss ) .", "the highest poe incidence occurred mainly in groups with increases in both weight and blood pressure .", "however , with long-term sibutramine treatment , a markedly lower blood pressure tended to increase poes .", "modest weight loss and modest lower blood pressure each reduced the incidence of cardiovascular events , as expected .", "however , the combination of early marked weight loss and rapid blood pressure reduction seems to be harmful in this obese elderly cardiovascular diseased population ." ]
the sibutramine cardiovascular outcomes ( scout ) trial showed a significantly increased relative risk of nonfatal cardiovascular events , but not mortality , in overweight and obese subjects receiving long-term sibutramine treatment with diet and exercise . we examined the relationship between early changes ( both increases and decreases ) in body weight and blood pressure , and the impact of these changes on subsequent cardiovascular outcome events . a total of @ male and female subjects , aged @ years or older , with a body mass index of @-@kgm ( -@ ) were included in this current subanalysis of the scout trial . subjects were required to have a history of cardiovascular disease and/or type @ diabetes mellitus with at least one cardiovascular risk factor ( hypertension , dyslipidemia , current smoking or diabetic nephropathy ) to assess cardiovascular outcomes . post hoc subgroup analyses of weight change ( categories ) and blood pressure were performed overall and by treatment group ( @-week sibutramine followed by randomized placebo or continued sibutramine ) . the primary outcome event ( poe ) was a composite of nonfatal myocardial infarction , nonfatal stroke , resuscitated cardiac arrest or cardiovascular death . time-to-event analyses of the poe were performed using cox regression models with factors for treatment , subgroups and interactions . during the initial @-week sibutramine treatment period , systolic blood pressure decreased progressively with increasing weight loss in hypertensive subjects ( -@ mmhg with < @kg weight loss to -@ mmhg with @kg weight loss ) . the highest poe incidence occurred mainly in groups with increases in both weight and blood pressure . however , with long-term sibutramine treatment , a markedly lower blood pressure tended to increase poes . modest weight loss and modest lower blood pressure each reduced the incidence of cardiovascular events , as expected . however , the combination of early marked weight loss and rapid blood pressure reduction seems to be harmful in this obese elderly cardiovascular diseased population .
24,406,481
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "breast neoplasms are the second most common type of cancer worldwide , and radiation therapy is a key component of their treatment .", "acute skin reactions are one of the most common side effects of radiation therapy , and prevention of this adverse event has been investigated in several studies .", "however , a clinically applicable , preventative treatment remains unavailable .", "it has been demonstrated that application of a low-power laser can promote tissue repair .", "therefore , the aim of this trial is to evaluate the effectiveness of an indium gallium aluminum phosphorus ( ingaaip ) laser operated at @nm in preventing radiodermatitis in women undergoing adjuvant radiotherapy for breast cancer .", "this is a two-arm , randomized controlled trial .", "a total of @ patients undergoing radiotherapy for breast cancer ( stages i to iii ) will be enrolled .", "patients will be randomly assigned to an intervention group to receive laser therapy ( n = @ ) or a control group to receive a placebo ( n = @ ) .", "the laser or placebo will be applied five days a week , immediately before each radiotherapy session .", "skin reactions will then be graded weekly by a nurse , a radiotherapist , and an oncologist ( all of whom will be blinded ) using the common toxicity criteria ( ctc ) developed by the national cancer institute and the acute radiation morbidity scoring criteria developed by the radiation therapy oncology group .", "patients will also answer a modified visual analogue scale for pain ( a self-evaluation questionnaire ) .", "primary and secondary outcomes will be the prevention of radiodermatitis and pain secondary to radiodermatitis , respectively .", "the ideal tool for preventing radiodermatitis is an agent that mediates dna repair or promotes cell proliferation .", "application of a low-power laser has been shown to promote tissue repair by reducing inflammation and inducing collagen synthesis .", "moreover , this treatment approach has not been associated with adverse events and is cost-effective .", "thus , the results of this ongoing trial may establish whether use of a low-power laser represents an ideal treatment option for the prevention of radiodermatitis .", "clinicaltrials.gov identifier : nct@ .", "registered on @ december @ ." ]
breast neoplasms are the second most common type of cancer worldwide , and radiation therapy is a key component of their treatment . acute skin reactions are one of the most common side effects of radiation therapy , and prevention of this adverse event has been investigated in several studies . however , a clinically applicable , preventative treatment remains unavailable . it has been demonstrated that application of a low-power laser can promote tissue repair . therefore , the aim of this trial is to evaluate the effectiveness of an indium gallium aluminum phosphorus ( ingaaip ) laser operated at @nm in preventing radiodermatitis in women undergoing adjuvant radiotherapy for breast cancer . this is a two-arm , randomized controlled trial . a total of @ patients undergoing radiotherapy for breast cancer ( stages i to iii ) will be enrolled . patients will be randomly assigned to an intervention group to receive laser therapy ( n = @ ) or a control group to receive a placebo ( n = @ ) . the laser or placebo will be applied five days a week , immediately before each radiotherapy session . skin reactions will then be graded weekly by a nurse , a radiotherapist , and an oncologist ( all of whom will be blinded ) using the common toxicity criteria ( ctc ) developed by the national cancer institute and the acute radiation morbidity scoring criteria developed by the radiation therapy oncology group . patients will also answer a modified visual analogue scale for pain ( a self-evaluation questionnaire ) . primary and secondary outcomes will be the prevention of radiodermatitis and pain secondary to radiodermatitis , respectively . the ideal tool for preventing radiodermatitis is an agent that mediates dna repair or promotes cell proliferation . application of a low-power laser has been shown to promote tissue repair by reducing inflammation and inducing collagen synthesis . moreover , this treatment approach has not been associated with adverse events and is cost-effective . thus , the results of this ongoing trial may establish whether use of a low-power laser represents an ideal treatment option for the prevention of radiodermatitis . clinicaltrials.gov identifier : nct@ . registered on @ december @ .
25,141,962
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND" ]
[ "to compare intercostal nerve block before and after rib harvest in terms of mean postoperative pain score and mean postoperative tramadol usage .", "randomized controlled trial .", "department of plastic surgery , mayo hospital , kemu , lahore , from january @ to july @ .", "patients ( n = @ ) of either gender with asa class-i and ii requiring autogenous costal cartilage graft were inducted .", "patients having history of local anaesthetic hypersensitivity and age < @ years or > @ years were excluded .", "subjects were randomly assigned to pre-rib harvest ( group-@ ) and post-rib harvest ( group-@ ) .", "local anaesthetic mixture was prepared by adding @ milliliters @ % lidocaine to @ milliliters @ % bupivacaine to obtain a total @ ml solution .", "group-@ received local anaesthetic infiltration along the proposed incision lines and intercostals block before the rib harvest .", "group-@ received the infiltration and block after rib harvest .", "postoperative consumption of tramadol and pain scores were measured at @ and @ hours postoperatively using vas .", "mean age was @ @ years .", "the mean pain scores at @ hours postoperatively were @ @ and @ @ in pre-rib harvest and post-rib harvest groups respectively ( p < @ ) .", "the mean pain scores at @ hours postoperatively were @ @ and @ @ in pre-rib harvest and post-rib harvest groups respectively ( p < @ ) .", "the mean tramadol used postoperatively in first @ hours was @ @ mg and @ @ mg in prerib harvest and post-rib harvest groups respectively ( p < @ ) .", "intercostal block administered before rib harvest as preemptive strategy result in decreased postoperative pain scores and narcotic use ." ]
to compare intercostal nerve block before and after rib harvest in terms of mean postoperative pain score and mean postoperative tramadol usage . randomized controlled trial . department of plastic surgery , mayo hospital , kemu , lahore , from january @ to july @ . patients ( n = @ ) of either gender with asa class-i and ii requiring autogenous costal cartilage graft were inducted . patients having history of local anaesthetic hypersensitivity and age < @ years or > @ years were excluded . subjects were randomly assigned to pre-rib harvest ( group-@ ) and post-rib harvest ( group-@ ) . local anaesthetic mixture was prepared by adding @ milliliters @ % lidocaine to @ milliliters @ % bupivacaine to obtain a total @ ml solution . group-@ received local anaesthetic infiltration along the proposed incision lines and intercostals block before the rib harvest . group-@ received the infiltration and block after rib harvest . postoperative consumption of tramadol and pain scores were measured at @ and @ hours postoperatively using vas . mean age was @ @ years . the mean pain scores at @ hours postoperatively were @ @ and @ @ in pre-rib harvest and post-rib harvest groups respectively ( p < @ ) . the mean pain scores at @ hours postoperatively were @ @ and @ @ in pre-rib harvest and post-rib harvest groups respectively ( p < @ ) . the mean tramadol used postoperatively in first @ hours was @ @ mg and @ @ mg in prerib harvest and post-rib harvest groups respectively ( p < @ ) . intercostal block administered before rib harvest as preemptive strategy result in decreased postoperative pain scores and narcotic use .
24,411,542
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the aim of this study was assessment of subendometrial blood flow with doppler ultrasonography as an indicator of endometrial receptivity in stimulated cycles for intrauterine insemination ( iui ) .", "this prospective study enrolled @ women scheduled for iui after ovarian stimulation randomly assigned to one of the three equal groups ; group ( c ) received clomiphene citrate , group ( h ) received hmg and group ( ch ) received clomiphene citrate in addition to hmg .", "all participants had ultrasound folliculometry starting on day @ , followed by transvaginal doppler study of the subendometrial blood flow and perifollicular blood flow on the day of detecting at least one follicle > @mm .", "resistivity index ( ri ) and pulsatility index ( pi ) of subendometrial and perifollicular flow were measured .", "endometrial thickness was measured on day of hcg injection .", "group ( h ) showed significantly higher frequency of subendometrial flow ( @ % ) compared to the other two groups ( p = @ ) .", "in cases of positive subendometrial flow , the ri and pi were significantly lower in group ( h ) compared to the other two groups ( p = @ and @ , respectively ) .", "endometrial thickness was significantly lower in group ( c ) compared to group ( h ) ( p < @ ) and group ( ch ) ( p < @ ) .", "successful intrauterine implantation was documented in a total of @ women ( @ % ) ; the highest frequency was in group ( h ) ( @ % ) and the lowest in group ( c ) , however , the difference between the three groups was not significant ( p = @ ) .", "subendometrial indices and perifollicular ri were significantly lower in cases of successful implantation , while endometrium was significantly thicker in these cases ( p < @ ) .", "the presence of subendometrial flow is associated with successful iui in women under stimulated cycles undergoing iui .", "hmg seems a superior option for induction of ovulation regarding success of implantation ." ]
the aim of this study was assessment of subendometrial blood flow with doppler ultrasonography as an indicator of endometrial receptivity in stimulated cycles for intrauterine insemination ( iui ) . this prospective study enrolled @ women scheduled for iui after ovarian stimulation randomly assigned to one of the three equal groups ; group ( c ) received clomiphene citrate , group ( h ) received hmg and group ( ch ) received clomiphene citrate in addition to hmg . all participants had ultrasound folliculometry starting on day @ , followed by transvaginal doppler study of the subendometrial blood flow and perifollicular blood flow on the day of detecting at least one follicle > @mm . resistivity index ( ri ) and pulsatility index ( pi ) of subendometrial and perifollicular flow were measured . endometrial thickness was measured on day of hcg injection . group ( h ) showed significantly higher frequency of subendometrial flow ( @ % ) compared to the other two groups ( p = @ ) . in cases of positive subendometrial flow , the ri and pi were significantly lower in group ( h ) compared to the other two groups ( p = @ and @ , respectively ) . endometrial thickness was significantly lower in group ( c ) compared to group ( h ) ( p < @ ) and group ( ch ) ( p < @ ) . successful intrauterine implantation was documented in a total of @ women ( @ % ) ; the highest frequency was in group ( h ) ( @ % ) and the lowest in group ( c ) , however , the difference between the three groups was not significant ( p = @ ) . subendometrial indices and perifollicular ri were significantly lower in cases of successful implantation , while endometrium was significantly thicker in these cases ( p < @ ) . the presence of subendometrial flow is associated with successful iui in women under stimulated cycles undergoing iui . hmg seems a superior option for induction of ovulation regarding success of implantation .
24,256,372
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to determine whether a single exposure to a manga comic ( japanese comic art ) with multiple messages promoting fruit intake influenced snack selection in minority urban youth .", "fifty-seven youth ( mean age @ y ; @ % female ; @ % black/african american ) attending after-school programs in brooklyn , ny participated in a pilot study in which they were randomly assigned to receive the comic or a non-health-related newsletter .", "after reading their media , participants were offered a snack and could choose from among healthy/unhealthy options .", "secondary outcomes included knowledge , self-efficacy , and outcome expectations related to fruit intake and media transportation .", "data were analyzed using regression and paired t test .", "comic group participants were significantly more likely to choose a healthy snack , compared to the attention-control group ( odds ratio = @ , @ % confidence interval : @-@ @ , p = @ ) .", "the comic group reported increases in self-efficacy ( p = @ ) and greater transportation ( immersion into media ) ( p = @ ) .", "results suggest manga comics may be a useful format to promote healthy snack selection in urban minority youth ." ]
to determine whether a single exposure to a manga comic ( japanese comic art ) with multiple messages promoting fruit intake influenced snack selection in minority urban youth . fifty-seven youth ( mean age @ y ; @ % female ; @ % black/african american ) attending after-school programs in brooklyn , ny participated in a pilot study in which they were randomly assigned to receive the comic or a non-health-related newsletter . after reading their media , participants were offered a snack and could choose from among healthy/unhealthy options . secondary outcomes included knowledge , self-efficacy , and outcome expectations related to fruit intake and media transportation . data were analyzed using regression and paired t test . comic group participants were significantly more likely to choose a healthy snack , compared to the attention-control group ( odds ratio = @ , @ % confidence interval : @-@ @ , p = @ ) . the comic group reported increases in self-efficacy ( p = @ ) and greater transportation ( immersion into media ) ( p = @ ) . results suggest manga comics may be a useful format to promote healthy snack selection in urban minority youth .
24,433,817
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "renal failure patients were treated with linezolid ( lzd ) for proven or suspected infections by multi-resistant gram-positive cocci .", "the aim of this study was to determine if dose adjustment of lzd is needed as a function of renal impairment or not , especially that a significant component of lzd is eliminated unchanged in urine .", "the single dose pharmacokinetics of lzd was investigated .", "eighteen non-infected male subjects with various degrees of renal impairment ranged from normal to severe chronic impairment were enrolled , including end-stage renal disease ( esrd ) patients maintained on hemodialysis ( hd ) .", "lzd was administered as a single oral @mg dose , and blood samples were drawn at different times and analysed by a validated hplc assay method .", "plasma profiles were evaluated by non-compartmental and compartmental approaches .", "a similar rate and extent of lzd absorption and elimination and comparable body exposure was observed in both healthy subjects and acute renal failure patients .", "the extent of lzd exposure was significantly increased by @-fold in esrd patients in their off-dialysis day .", "furthermore , the t@/@ and mrt values were significantly increased by ~ @ - and @-fold , respectively .", "the vd / f values of lzd did not change with renal function .", "a significant decrease in cl/f by ~ @-fold was observed in esrd patients in their off-dialysis day however , cl/f was significantly increased by ~ @-fold during hd .", "approximately half of the administered lzd dose was removed during the hd session in these selected cohorts of esrd patients .", "lzd was generally well tolerated .", "the dose of lzd did not need to be adjusted for patients with acute renal dysfunction or esrd on hd .", "one of the twice-daily doses should be administered after the dialysis session because almost half of the lzd dose was substantially removed by hd .", "during the first three dialysis sessions of the treatment course , to avoid potentially ineffective therapy , a supplemental dose of lzd might be given if necessary or the dose of lzd should be administered @h before the beginning of the hd session .", "this was to keep lzd levels above the mic for the organism causing the infection being treated ." ]
renal failure patients were treated with linezolid ( lzd ) for proven or suspected infections by multi-resistant gram-positive cocci . the aim of this study was to determine if dose adjustment of lzd is needed as a function of renal impairment or not , especially that a significant component of lzd is eliminated unchanged in urine . the single dose pharmacokinetics of lzd was investigated . eighteen non-infected male subjects with various degrees of renal impairment ranged from normal to severe chronic impairment were enrolled , including end-stage renal disease ( esrd ) patients maintained on hemodialysis ( hd ) . lzd was administered as a single oral @mg dose , and blood samples were drawn at different times and analysed by a validated hplc assay method . plasma profiles were evaluated by non-compartmental and compartmental approaches . a similar rate and extent of lzd absorption and elimination and comparable body exposure was observed in both healthy subjects and acute renal failure patients . the extent of lzd exposure was significantly increased by @-fold in esrd patients in their off-dialysis day . furthermore , the t@/@ and mrt values were significantly increased by ~ @ - and @-fold , respectively . the vd / f values of lzd did not change with renal function . a significant decrease in cl/f by ~ @-fold was observed in esrd patients in their off-dialysis day however , cl/f was significantly increased by ~ @-fold during hd . approximately half of the administered lzd dose was removed during the hd session in these selected cohorts of esrd patients . lzd was generally well tolerated . the dose of lzd did not need to be adjusted for patients with acute renal dysfunction or esrd on hd . one of the twice-daily doses should be administered after the dialysis session because almost half of the lzd dose was substantially removed by hd . during the first three dialysis sessions of the treatment course , to avoid potentially ineffective therapy , a supplemental dose of lzd might be given if necessary or the dose of lzd should be administered @h before the beginning of the hd session . this was to keep lzd levels above the mic for the organism causing the infection being treated .
25,044,219
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "changes in diet and exercise have been separately demonstrated to improve depression , although scientific evidence available is scarce .", "in a previously published controlled study , just recommending these and other lifestyle measures ( sleep restriction and sunlight exposure ) in combination once , patients experienced improvements in their depressive symptoms six months later .", "in this sample , one in three depressive patients had metabolic syndrome ( mets ) at baseline .", "first line treatment of mets condition is hygienic-dietetic , being mediterranean diet and exercise especially important .", "therefore we analyzed if lifestyle recommendations also improved their metabolic profile .", "during the sixth month evaluation , a smaller number of patients from the group receiving hygienic-dietary recommendations met mets criteria comparing with the control group .", "this study suggests that costless lifestyle recommendations , such as exercise and mediterranean diet , have the capacity to promote both mental and physical health in a significant proportion of depressive patients .", "further research is needed to confirm or discard these preliminary findings ." ]
changes in diet and exercise have been separately demonstrated to improve depression , although scientific evidence available is scarce . in a previously published controlled study , just recommending these and other lifestyle measures ( sleep restriction and sunlight exposure ) in combination once , patients experienced improvements in their depressive symptoms six months later . in this sample , one in three depressive patients had metabolic syndrome ( mets ) at baseline . first line treatment of mets condition is hygienic-dietetic , being mediterranean diet and exercise especially important . therefore we analyzed if lifestyle recommendations also improved their metabolic profile . during the sixth month evaluation , a smaller number of patients from the group receiving hygienic-dietary recommendations met mets criteria comparing with the control group . this study suggests that costless lifestyle recommendations , such as exercise and mediterranean diet , have the capacity to promote both mental and physical health in a significant proportion of depressive patients . further research is needed to confirm or discard these preliminary findings .
24,899,528
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to assess the effects of oral and transdermal hormone replacement therapies ( hrt ) on levels of important cardiovascular disease ( cvd ) markers , mcp-@ and homocyteine , in the early postmenopausal period .", "seventy-six healthy , early postmenopausal women were enrolled in the study .", "patients were randomly assigned to receive oral or transdermal hrt for @ months .", "the first group received continuous combined oral hrt containing @mg @-estradiol and @ mg norethisterone acetate ( n = @ ) , and the second group received sequential transdermal hrt releasing @g/day estradiol alone given twice a week on days @-@ and @g/day estradiol plus @ mg/day norethisterone acetate given twice a week on days @-@ ( n = @ ) .", "circulating levels of mcp-@ and homocysteine , along with other cvd markers , were assessed before and after treatment in all patients .", "there were no significant differences between the baseline characteristics of the two groups .", "baseline serum mcp-@ levels were similar between the oral and transdermal hrt groups ( @ vs. @ pg/ml ; p = @ ) .", "the mean mcp-@ levels did not change after @ months of hrt in both oral ( @ vs. @ pg/ml ; p = @ ) and transdermal hrt groups ( @ vs. @ pg/ml ; p = @ ) .", "moreover , there was no significant difference between the groups in mcp-@ serum levels after @ months of hrt .", "similarly , no difference was found in serum homocyteine levels following @ months of hrt .", "both oral continuous and sequential transdermal hrts do not have significant effects on serum mcp-@ and homocyteine levels in women during the early postmenopausal period ." ]
to assess the effects of oral and transdermal hormone replacement therapies ( hrt ) on levels of important cardiovascular disease ( cvd ) markers , mcp-@ and homocyteine , in the early postmenopausal period . seventy-six healthy , early postmenopausal women were enrolled in the study . patients were randomly assigned to receive oral or transdermal hrt for @ months . the first group received continuous combined oral hrt containing @mg @-estradiol and @ mg norethisterone acetate ( n = @ ) , and the second group received sequential transdermal hrt releasing @g/day estradiol alone given twice a week on days @-@ and @g/day estradiol plus @ mg/day norethisterone acetate given twice a week on days @-@ ( n = @ ) . circulating levels of mcp-@ and homocysteine , along with other cvd markers , were assessed before and after treatment in all patients . there were no significant differences between the baseline characteristics of the two groups . baseline serum mcp-@ levels were similar between the oral and transdermal hrt groups ( @ vs. @ pg/ml ; p = @ ) . the mean mcp-@ levels did not change after @ months of hrt in both oral ( @ vs. @ pg/ml ; p = @ ) and transdermal hrt groups ( @ vs. @ pg/ml ; p = @ ) . moreover , there was no significant difference between the groups in mcp-@ serum levels after @ months of hrt . similarly , no difference was found in serum homocyteine levels following @ months of hrt . both oral continuous and sequential transdermal hrts do not have significant effects on serum mcp-@ and homocyteine levels in women during the early postmenopausal period .
24,655,552
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the j-rocket af study found that rivaroxaban was non-inferior to warfarin with respect to the principal safety outcome in patients with atrial fibrillation ( af ) .", "the aim of this subgroup analysis was to assess the safety and efficacy of rivaroxaban and warfarin in relation to patient age .", "a total of @ % were elderly ( aged @ years ) .", "in elderly patients , the principal safety outcome occurred at @ % / year with rivaroxaban vs. @ % / year on warfarin ( hazard ratio -lsb- hr -rsb- , @ ; @ % confidence interval -lsb- ci -rsb- : @-@ @ ) , whereas the primary efficacy endpoint occurred at @ % / year vs. @ % / year ( hr , @ ; @ % ci : @-@ @ ) , respectively .", "there were significant interactions in the principal safety outcomes of rivaroxaban compared with warfarin between the elderly and non-elderly groups , but not in the primary efficacy endpoints ( p = @ and @ for both interactions , respectively ) .", "furthermore , in elderly patients , in the rivaroxaban group there was a trend to increase the principal safety outcome regardless of renal function .", "in elderly patients with preserved renal function , however , patients on rivaroxaban had a marginally favorable trend in the primary efficacy endpoint incidence rate compared with patients on warfarin .", "there is a need to carefully consider the risks and benefits of therapy with rivaroxaban in elderly patients with non-valvular af ." ]
the j-rocket af study found that rivaroxaban was non-inferior to warfarin with respect to the principal safety outcome in patients with atrial fibrillation ( af ) . the aim of this subgroup analysis was to assess the safety and efficacy of rivaroxaban and warfarin in relation to patient age . a total of @ % were elderly ( aged @ years ) . in elderly patients , the principal safety outcome occurred at @ % / year with rivaroxaban vs. @ % / year on warfarin ( hazard ratio -lsb- hr -rsb- , @ ; @ % confidence interval -lsb- ci -rsb- : @-@ @ ) , whereas the primary efficacy endpoint occurred at @ % / year vs. @ % / year ( hr , @ ; @ % ci : @-@ @ ) , respectively . there were significant interactions in the principal safety outcomes of rivaroxaban compared with warfarin between the elderly and non-elderly groups , but not in the primary efficacy endpoints ( p = @ and @ for both interactions , respectively ) . furthermore , in elderly patients , in the rivaroxaban group there was a trend to increase the principal safety outcome regardless of renal function . in elderly patients with preserved renal function , however , patients on rivaroxaban had a marginally favorable trend in the primary efficacy endpoint incidence rate compared with patients on warfarin . there is a need to carefully consider the risks and benefits of therapy with rivaroxaban in elderly patients with non-valvular af .
24,705,469
[ "BACKGROUND", "BACKGROUND", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the study objectives were to analyze the impact of the number of lymph nodes ( lns ) reported as resected ( nlnr ) and the number of lns invaded ( nlni ) on the prognosis of esophageal cancer ( ec ) after neoadjuvant chemoradiotherapy .", "pathological ln status is a major disease prognostic factor and marker of surgical quality .", "the impact of neoadjuvant chemoradiation ( ncrt ) on ln status remains poorly studied in ec .", "post hoc analysis from a phase iii randomized controlled trial comparing ncrt and surgery ( group ncrt ) to surgery alone ( group s ) in stage i and ii ec ( nct@ ) .", "only patients who underwent surgical resection were considered ( n = @ ) .", "ncrt resulted in tumoral downstaging ( pt@ , @ % vs @ % , p < @ ) , ln downstaging ( pn@ , @ % vs @ % , p = @ ) , and reduction in the median nlnr -lsb- @ ( range , @-@ @ ) vs @ ( range , @-@ @ ) , p = @ -rsb- and nlni -lsb- @ ( range , @-@ ) vs @ ( range , @-@ ) , p = @ -rsb- .", "a good histological response ( trg@/@ ) in the resected esophageal specimen correlated with reduced median nlni -lsb- @ ( range , @-@ ) vs @ ( range , @-@ ) , p = @ -rsb- .", "after adjustment by treatment , nlni -lsb- hazards ratio ( hr ) ( @-@ vs @ ) @ , @ % confidence interval ( ci ) : @-@ @ , and hr ( > @ vs @ ) @ , @ % ci : @-@ @ , p < @ -rsb- correlated with prognosis , whereas nlnr -lsb- hr ( < @ vs @ ) @ , @ % ci : @-@ @ , p = @ and hr ( < @ vs @ ) @ , @ % ci : @-@ @ , p = @ -rsb- did not .", "in poisson regression analysis , ncrt was an independent predictive variable for reduced nlnr -lsb- exp ( coefficient ) @ , @ % ci : @-@ @ , p = @ -rsb- .", "ncrt is not only responsible for disease downstaging but also predicts fewer lns being identified after surgical resection for ec .", "this has implications for the current quality criteria for surgical resection ." ]
the study objectives were to analyze the impact of the number of lymph nodes ( lns ) reported as resected ( nlnr ) and the number of lns invaded ( nlni ) on the prognosis of esophageal cancer ( ec ) after neoadjuvant chemoradiotherapy . pathological ln status is a major disease prognostic factor and marker of surgical quality . the impact of neoadjuvant chemoradiation ( ncrt ) on ln status remains poorly studied in ec . post hoc analysis from a phase iii randomized controlled trial comparing ncrt and surgery ( group ncrt ) to surgery alone ( group s ) in stage i and ii ec ( nct@ ) . only patients who underwent surgical resection were considered ( n = @ ) . ncrt resulted in tumoral downstaging ( pt@ , @ % vs @ % , p < @ ) , ln downstaging ( pn@ , @ % vs @ % , p = @ ) , and reduction in the median nlnr -lsb- @ ( range , @-@ @ ) vs @ ( range , @-@ @ ) , p = @ -rsb- and nlni -lsb- @ ( range , @-@ ) vs @ ( range , @-@ ) , p = @ -rsb- . a good histological response ( trg@/@ ) in the resected esophageal specimen correlated with reduced median nlni -lsb- @ ( range , @-@ ) vs @ ( range , @-@ ) , p = @ -rsb- . after adjustment by treatment , nlni -lsb- hazards ratio ( hr ) ( @-@ vs @ ) @ , @ % confidence interval ( ci ) : @-@ @ , and hr ( > @ vs @ ) @ , @ % ci : @-@ @ , p < @ -rsb- correlated with prognosis , whereas nlnr -lsb- hr ( < @ vs @ ) @ , @ % ci : @-@ @ , p = @ and hr ( < @ vs @ ) @ , @ % ci : @-@ @ , p = @ -rsb- did not . in poisson regression analysis , ncrt was an independent predictive variable for reduced nlnr -lsb- exp ( coefficient ) @ , @ % ci : @-@ @ , p = @ -rsb- . ncrt is not only responsible for disease downstaging but also predicts fewer lns being identified after surgical resection for ec . this has implications for the current quality criteria for surgical resection .
25,361,220
[ "OBJECTIVE", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to compare the effects and postoperative complications between tissue selecting therapy stapler ( tst ) and milligan-morgan hemorrhoidectomy ( m-m ) .", "four hundred and eighty patients with severe prolapsing hemorrhoids , who were admitted to the shenyang coloproctology hospital between @ and @ , were randomly divided into observation ( n = @ ) and control ( n = @ ) groups .", "hemorrhoidectomies were performed with tst in the observation group and with the m-m technique in the control group .", "the therapeutic effects , operation security , and postoperative complications in the two groups were compared .", "the immediate and long-term complications were assessed according to corresponding criteria .", "pain was assessed on a visual analogue scale .", "the efficacy was assessed by specialized criteria .", "the follow-up was conducted one year after the operation .", "the total effective rates of the observation and control groups were @ % ( @/@ ) and @ % ( @/@ ) respectively ; the difference was not statistically significant ( p = @ ) .", "their were significant differences between observation and control groups in intraoperative blood loss ( @ vs @ , p = @ ) , pain ( @ h after the surgery : @ vs @ , p = @ ; at first dressing change : @ vs @ , p = @ ; first defecation : @ vs @ , p = @ ) , urine retention ( n = @ vs n = @ , p = @ ) , anal pendant expansion after the surgery ( @ vs @ , p = @ ) , operation time ( @ min vs @ min , p = @ ) , and the length of hospital stay ( @ d vs @ d , p = @ ) .", "moreover tst showed significant reductions compared to m-m in the rates of long-term complications such as fecal incontinence ( n = @ vs n = @ , p = @ ) , difficult bowel movement ( n = @ vs n = @ , p = @ ) , intractable pain ( n = @ vs n = @ , p = @ ) , and anal discharge ( n = @ vs n = @ , p = @ ) .", "tst for severe prolapsing hemorrhoids is a satisfactory technique for more rapid recovery , lower complication rates , and higher operation security ." ]
to compare the effects and postoperative complications between tissue selecting therapy stapler ( tst ) and milligan-morgan hemorrhoidectomy ( m-m ) . four hundred and eighty patients with severe prolapsing hemorrhoids , who were admitted to the shenyang coloproctology hospital between @ and @ , were randomly divided into observation ( n = @ ) and control ( n = @ ) groups . hemorrhoidectomies were performed with tst in the observation group and with the m-m technique in the control group . the therapeutic effects , operation security , and postoperative complications in the two groups were compared . the immediate and long-term complications were assessed according to corresponding criteria . pain was assessed on a visual analogue scale . the efficacy was assessed by specialized criteria . the follow-up was conducted one year after the operation . the total effective rates of the observation and control groups were @ % ( @/@ ) and @ % ( @/@ ) respectively ; the difference was not statistically significant ( p = @ ) . their were significant differences between observation and control groups in intraoperative blood loss ( @ vs @ , p = @ ) , pain ( @ h after the surgery : @ vs @ , p = @ ; at first dressing change : @ vs @ , p = @ ; first defecation : @ vs @ , p = @ ) , urine retention ( n = @ vs n = @ , p = @ ) , anal pendant expansion after the surgery ( @ vs @ , p = @ ) , operation time ( @ min vs @ min , p = @ ) , and the length of hospital stay ( @ d vs @ d , p = @ ) . moreover tst showed significant reductions compared to m-m in the rates of long-term complications such as fecal incontinence ( n = @ vs n = @ , p = @ ) , difficult bowel movement ( n = @ vs n = @ , p = @ ) , intractable pain ( n = @ vs n = @ , p = @ ) , and anal discharge ( n = @ vs n = @ , p = @ ) . tst for severe prolapsing hemorrhoids is a satisfactory technique for more rapid recovery , lower complication rates , and higher operation security .
25,741,159
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "transenteral ( te ) administration of a bowel cleanser prior to colonoscopy avoids the discomfort associated with drinking a large volume of unpalatable cleanser .", "to explore patient comfort , preference for future colonoscopy , the efficacy and adverse events associated with te bowel preparation .", "bowel preparation is traditionally practised using polyethylene glycol ( peg ) + ascorbic acid ( asc ) , which was the treatment used in the control group ( peroral group ; po group ) .", "in the study group ( te group ) , peg + asc were administered directly to the third portion of the duodenum through a scope immediately after completing upper gastrointestinal endoscopy .", "a higher proportion of subjects in the te group graded their degree of comfort as very or rather comfortable ( @ % in the po group , @ % in the te group ; p = @ ) and had greater preference for future colonoscopy ( @ % in the po group , @ % in the te group ; p = @ ) , compared with the po group .", "the te group had non-inferiority in efficacy compared with the po group ( non-inferiority margin -@ % ; lower limit of @ % confidence interval for difference between success rates -@ % , when using the aronchick scale , and -@ % when using the ottawa scale ) .", "nausea or vomiting were more prevalent during preparation in the po group ( @ vs. @ % ; p = @ ) , and dizziness was more common in the te group ( @ vs. @ % ; p = @ ) .", "te preparation was found to be more comfortable than the traditional peroral method and not inferior in efficacy .", "the adverse events rate was acceptable ." ]
transenteral ( te ) administration of a bowel cleanser prior to colonoscopy avoids the discomfort associated with drinking a large volume of unpalatable cleanser . to explore patient comfort , preference for future colonoscopy , the efficacy and adverse events associated with te bowel preparation . bowel preparation is traditionally practised using polyethylene glycol ( peg ) + ascorbic acid ( asc ) , which was the treatment used in the control group ( peroral group ; po group ) . in the study group ( te group ) , peg + asc were administered directly to the third portion of the duodenum through a scope immediately after completing upper gastrointestinal endoscopy . a higher proportion of subjects in the te group graded their degree of comfort as very or rather comfortable ( @ % in the po group , @ % in the te group ; p = @ ) and had greater preference for future colonoscopy ( @ % in the po group , @ % in the te group ; p = @ ) , compared with the po group . the te group had non-inferiority in efficacy compared with the po group ( non-inferiority margin -@ % ; lower limit of @ % confidence interval for difference between success rates -@ % , when using the aronchick scale , and -@ % when using the ottawa scale ) . nausea or vomiting were more prevalent during preparation in the po group ( @ vs. @ % ; p = @ ) , and dizziness was more common in the te group ( @ vs. @ % ; p = @ ) . te preparation was found to be more comfortable than the traditional peroral method and not inferior in efficacy . the adverse events rate was acceptable .
25,193,390
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the rebif flexible dosing in early ms ( reflex ) study compared several brain mri outcomes in patients presenting with clinically isolated syndromes suggestive of multiple sclerosis and treated with two dose-frequencies of subcutaneous interferon ( ifn ) -@ a or placebo .", "patients were randomised ( @:@:@ ) to ifn -@ a , @ g subcutaneously three times a week or once a week , or placebo three times a week for up to @ months .", "mri scans were performed every @ months , or every @ months if the patient developed clinically definite multiple sclerosis .", "end points analysed included : number of combined unique active lesions per patient per scan ; numbers and volumes of new t@ , t@ hypointense and gadolinium-enhancing ( gd + ) lesions per patient per scan ; and brain volume .", "@ patients were randomised ( intent-to-treat population : subcutaneous ifn -@ a three times a week , n = @ ; subcutaneous ifn -@ a once a week , n = @ ; placebo , n = @ ) .", "combined unique active lesions were lower in patients treated with subcutaneous ifn -@ a versus placebo ( mean ( sd ) lesions per patient per scan : three times a week @ ( @ ) ; once a week @ ( @ ) ; placebo @ ( @ ) ; reduction versus placebo : three times a week @ % ; once a week @ % ; p < @ ) and with three times a week versus once a week ( @ % reduction ; p = @ ) .", "the mean numbers of new t@ , t@ hypointense and gd + lesions were all significantly lower in the two active treatment arms compared with placebo ( p@ @ for three times a week or once a week ) and in the three times a week group compared with once a week ( p@ @ ) .", "both subcutaneous ifn -@ a @ g regimens improved mri outcomes versus placebo , with the three times a week regimen having a more pronounced effect than once a week dosing .", "clinicaltrial.gov identifier , nct@ ." ]
the rebif flexible dosing in early ms ( reflex ) study compared several brain mri outcomes in patients presenting with clinically isolated syndromes suggestive of multiple sclerosis and treated with two dose-frequencies of subcutaneous interferon ( ifn ) -@ a or placebo . patients were randomised ( @:@:@ ) to ifn -@ a , @ g subcutaneously three times a week or once a week , or placebo three times a week for up to @ months . mri scans were performed every @ months , or every @ months if the patient developed clinically definite multiple sclerosis . end points analysed included : number of combined unique active lesions per patient per scan ; numbers and volumes of new t@ , t@ hypointense and gadolinium-enhancing ( gd + ) lesions per patient per scan ; and brain volume . @ patients were randomised ( intent-to-treat population : subcutaneous ifn -@ a three times a week , n = @ ; subcutaneous ifn -@ a once a week , n = @ ; placebo , n = @ ) . combined unique active lesions were lower in patients treated with subcutaneous ifn -@ a versus placebo ( mean ( sd ) lesions per patient per scan : three times a week @ ( @ ) ; once a week @ ( @ ) ; placebo @ ( @ ) ; reduction versus placebo : three times a week @ % ; once a week @ % ; p < @ ) and with three times a week versus once a week ( @ % reduction ; p = @ ) . the mean numbers of new t@ , t@ hypointense and gd + lesions were all significantly lower in the two active treatment arms compared with placebo ( p@ @ for three times a week or once a week ) and in the three times a week group compared with once a week ( p@ @ ) . both subcutaneous ifn -@ a @ g regimens improved mri outcomes versus placebo , with the three times a week regimen having a more pronounced effect than once a week dosing . clinicaltrial.gov identifier , nct@ .
24,292,999
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]
[ "adjunctive-to-insulin therapy with sodium-glucose cotransporter @ ( sglt@ ) inhibition may improve glycemic control in type @ diabetes ( t@d ) .", "we evaluated the glycemic efficacy and safety of empagliflozin @ mg daily in @ patients treated for @ weeks in a single-arm open-label proof-of-concept trial ( nct@ ) .", "mean a@c decreased from @ @ % ( @ @ mmol/mol ) to @ @ % ( @ @ mmol/mol ) ( p < @ ) , fasting glucose from @ @ to @ @ mmol/l ( p = @ ) , symptomatic hypoglycemia ( < @ mmol/l ) from @ to @ events per patient per day ( p = @ ) , and daily insulin dose from @ @ to @ @ units/day ( p < @ ) .", "mean urinary excretion of glucose increased from @ @ to @ @ g/day ( p < @ ) .", "weight decreased from @ @ to @ @ kg ( p < @ ) , and waist circumference decreased from @ @ to @ @ cm ( p < @ ) .", "this proof-of-concept study strongly supports a randomized clinical trial of adjunctive-to-insulin empagliflozin in patients with t@d ." ]
adjunctive-to-insulin therapy with sodium-glucose cotransporter @ ( sglt@ ) inhibition may improve glycemic control in type @ diabetes ( t@d ) . we evaluated the glycemic efficacy and safety of empagliflozin @ mg daily in @ patients treated for @ weeks in a single-arm open-label proof-of-concept trial ( nct@ ) . mean a@c decreased from @ @ % ( @ @ mmol/mol ) to @ @ % ( @ @ mmol/mol ) ( p < @ ) , fasting glucose from @ @ to @ @ mmol/l ( p = @ ) , symptomatic hypoglycemia ( < @ mmol/l ) from @ to @ events per patient per day ( p = @ ) , and daily insulin dose from @ @ to @ @ units/day ( p < @ ) . mean urinary excretion of glucose increased from @ @ to @ @ g/day ( p < @ ) . weight decreased from @ @ to @ @ kg ( p < @ ) , and waist circumference decreased from @ @ to @ @ cm ( p < @ ) . this proof-of-concept study strongly supports a randomized clinical trial of adjunctive-to-insulin empagliflozin in patients with t@d .
24,595,630
[ "OBJECTIVE", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "heavy drinking is common among students at uk universities .", "us students overestimate how much their peers drink and correcting this through the use of social norm messages may promote responsible drinking .", "we tested whether there is an association between perceived campus drinking norms and usual drinking behavior in uk university students and whether norm messages about responsible drinking correct normative misperceptions and increase students ' intentions to drink responsibly .", "@,@ uk university students took part in an online study .", "participants were exposed to one of five message types : a descriptive norm , an injunctive norm , a descriptive and injunctive norm , or one of two control messages .", "message credibility was assessed .", "afterwards participants completed measures of intentions to drink responsibly and we measured usual drinking habits and perceptions of peer drinking .", "perceptions of peer drinking were associated modestly with usual drinking behavior , whereby participants who believed other students drank responsibly also drank responsibly .", "norm messages changed normative perceptions , but not in the target population of participants who underestimated responsible drinking in their peers at baseline .", "norm messages did not increase intentions to drink responsibly and although based on accurate data , norm messages were not seen as credible .", "in this uk based study , although perceived social norms about peer drinking were associated with individual differences in drinking habits , campus wide norm messages about responsible drinking did not affect students ' intentions to drink more responsibly .", "more research is required to determine if this approach can be applied to uk settings ." ]
heavy drinking is common among students at uk universities . us students overestimate how much their peers drink and correcting this through the use of social norm messages may promote responsible drinking . we tested whether there is an association between perceived campus drinking norms and usual drinking behavior in uk university students and whether norm messages about responsible drinking correct normative misperceptions and increase students ' intentions to drink responsibly . @,@ uk university students took part in an online study . participants were exposed to one of five message types : a descriptive norm , an injunctive norm , a descriptive and injunctive norm , or one of two control messages . message credibility was assessed . afterwards participants completed measures of intentions to drink responsibly and we measured usual drinking habits and perceptions of peer drinking . perceptions of peer drinking were associated modestly with usual drinking behavior , whereby participants who believed other students drank responsibly also drank responsibly . norm messages changed normative perceptions , but not in the target population of participants who underestimated responsible drinking in their peers at baseline . norm messages did not increase intentions to drink responsibly and although based on accurate data , norm messages were not seen as credible . in this uk based study , although perceived social norms about peer drinking were associated with individual differences in drinking habits , campus wide norm messages about responsible drinking did not affect students ' intentions to drink more responsibly . more research is required to determine if this approach can be applied to uk settings .
24,730,564
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "oxaliplatin is an integral component of colorectal cancer treatment , but its use is limited by neurotoxicity .", "the combined oxaliplatin neurotoxicity prevention trial ( concept ) tested intermittent oxaliplatin ( io ) administration and the use of concurrent calcium and magnesium salts ( ca/mg ) , two modifications intended to reduce neurotoxicity and extend the duration of treatment .", "in this trial involving double randomization , @ patients were randomized to receive modified folfox@ plus bevacizumab with io ( eight-cycle blocks of oxaliplatin treatment ) versus continuous oxaliplatin ( co ) ; and ca/mg versus placebo ( pre - and postoxaliplatin infusion ) .", "the primary end point was time-to-treatment failure ( ttf ) .", "one hundred thirty-nine patients were entered and treated up to the point of early study termination due to concerns by the data-monitoring committee ( dmc ) that ca/mg adversely affected tumor response .", "tumor response was not a study end point .", "given dmc concerns , an additional independent , blinded radiology review of all images showed no adverse effect of treatment schedule or ca/mg on response by response evaluation criteria in solid tumors .", "the io schedule was superior to co -lsb- hazard ratio ( hr ) = @ , p = @ -rsb- for both ttf and time-to-tumor progression ( ttp ) ( hr = @ , p = @ ) .", "an io dosing schedule had a significant benefit on both ttf and ttp versus co dosing in this trial despite the very attenuated sample .", "there was no effect of ca/mg on response ." ]
oxaliplatin is an integral component of colorectal cancer treatment , but its use is limited by neurotoxicity . the combined oxaliplatin neurotoxicity prevention trial ( concept ) tested intermittent oxaliplatin ( io ) administration and the use of concurrent calcium and magnesium salts ( ca/mg ) , two modifications intended to reduce neurotoxicity and extend the duration of treatment . in this trial involving double randomization , @ patients were randomized to receive modified folfox@ plus bevacizumab with io ( eight-cycle blocks of oxaliplatin treatment ) versus continuous oxaliplatin ( co ) ; and ca/mg versus placebo ( pre - and postoxaliplatin infusion ) . the primary end point was time-to-treatment failure ( ttf ) . one hundred thirty-nine patients were entered and treated up to the point of early study termination due to concerns by the data-monitoring committee ( dmc ) that ca/mg adversely affected tumor response . tumor response was not a study end point . given dmc concerns , an additional independent , blinded radiology review of all images showed no adverse effect of treatment schedule or ca/mg on response by response evaluation criteria in solid tumors . the io schedule was superior to co -lsb- hazard ratio ( hr ) = @ , p = @ -rsb- for both ttf and time-to-tumor progression ( ttp ) ( hr = @ , p = @ ) . an io dosing schedule had a significant benefit on both ttf and ttp versus co dosing in this trial despite the very attenuated sample . there was no effect of ca/mg on response .
24,608,198
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "new-generation drug-eluting coronary stents have reduced the risk of coronary events , especially in patients with complex disease or lesions .", "to what extent different stent platforms , polymers , and antiproliferative drugs affect outcomes , however , is unclear .", "we investigated the safety and efficacy of a third-generation stent by comparing a highly biocompatible durable-polymer-coated zotarolimus-eluting stent with a biodegradable-polymer-coated biolimus-eluting stent .", "this open-label , randomised , multicentre , non-inferiority trial was done at three sites across western denmark .", "all patients who presented with stable coronary artery disease or acute coronary syndromes and at least one coronary artery lesion ( more than @ % stenosis ) from march , @ , to august , @ , were assessed for eligibility .", "patients were randomly assigned in a @:@ ratio to receive either the durable-polymer zotarolimus-eluting stent or the biodegradable-polymer biolimus-eluting stent .", "the primary endpoint was a composite of safety ( cardiac death and myocardial infarction not clearly attributable to a non-target lesion ) and efficacy ( target-lesion revascularisation ) at @ months , analysed by intention to treat .", "the trial was powered to assess non-inferiority of durable-polymer zotarolimus-eluting stent compared with the biodegradable-polymer biolimus-eluting stent with a predetermined non-inferiority margin of @ .", "this trial is registered with clinicaltrials.gov , number nct@ .", "of @ screened , @ patients with @ lesions were assigned to receive the durable-polymer zotarolimus-eluting stent and @ patients with @ lesions to receive the biodegradable-polymer biolimus-eluting stent .", "@ ( @ % ) and @ ( @ % ) patients , respectively , met the primary endpoint ( absolute risk difference @ , upper limit of one-sided @ % ci @ % ; p = @ ) .", "the individual components of the primary endpoint did not differ significantly between stent types at @ months .", "the durable-polymer-coated zotarolimus-eluting stent was non-inferior to the biodegradable-polymer-coated biolimus-eluting stent in unselected patients .", "medtronic cardiovascular and biosensors interventional technologies ." ]
new-generation drug-eluting coronary stents have reduced the risk of coronary events , especially in patients with complex disease or lesions . to what extent different stent platforms , polymers , and antiproliferative drugs affect outcomes , however , is unclear . we investigated the safety and efficacy of a third-generation stent by comparing a highly biocompatible durable-polymer-coated zotarolimus-eluting stent with a biodegradable-polymer-coated biolimus-eluting stent . this open-label , randomised , multicentre , non-inferiority trial was done at three sites across western denmark . all patients who presented with stable coronary artery disease or acute coronary syndromes and at least one coronary artery lesion ( more than @ % stenosis ) from march , @ , to august , @ , were assessed for eligibility . patients were randomly assigned in a @:@ ratio to receive either the durable-polymer zotarolimus-eluting stent or the biodegradable-polymer biolimus-eluting stent . the primary endpoint was a composite of safety ( cardiac death and myocardial infarction not clearly attributable to a non-target lesion ) and efficacy ( target-lesion revascularisation ) at @ months , analysed by intention to treat . the trial was powered to assess non-inferiority of durable-polymer zotarolimus-eluting stent compared with the biodegradable-polymer biolimus-eluting stent with a predetermined non-inferiority margin of @ . this trial is registered with clinicaltrials.gov , number nct@ . of @ screened , @ patients with @ lesions were assigned to receive the durable-polymer zotarolimus-eluting stent and @ patients with @ lesions to receive the biodegradable-polymer biolimus-eluting stent . @ ( @ % ) and @ ( @ % ) patients , respectively , met the primary endpoint ( absolute risk difference @ , upper limit of one-sided @ % ci @ % ; p = @ ) . the individual components of the primary endpoint did not differ significantly between stent types at @ months . the durable-polymer-coated zotarolimus-eluting stent was non-inferior to the biodegradable-polymer-coated biolimus-eluting stent in unselected patients . medtronic cardiovascular and biosensors interventional technologies .
25,601,789
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]
[ "to explore the efficacy and effect mechanism of the combined therapy of acupuncture and tapping method in the treatment of obesity and hyperlipidemia of liver qi stagnation and spleen deficiency pattern in the patients .", "one hundred and four female patients were randomized into a combined therapy of acupuncture and tapping ( combined therapy group ) group method and an acupuncture group , @ cases in each group .", "in the acupuncture group , acupuncture was applied to qimen ( lr @ ) , taichong ( lr @ ) , zhangmen ( lr @ ) , taibai ( sp @ ) , zusanli ( st @ ) , geshu ( bl @ ) , ganshu ( bl @ ) , pishu ( bl @ ) , etc. .", "in the combined therapy group , on the basis of acupuncture treatment , the tapping method with plum blossom needle was used at each acupoint .", "the treatment was given once every two days , continuously for @ months in the two groups .", "the indices were observed , including the obesity indices , such as body mass , body mass index ( bmi ) , body fat percentage ( f % ) and obesity degree ( a ) ; the blood lipid levels such as total cholesterol ( tc ) , triglyceride ( tg ) , low density lipoprotein ( ldl ) and high density lipoprotein ( hdl ) ; the fat-islet axie relevant indices such as fasting plasma glucose ( fbs ) , fasting leptin ( flp ) , fasting insulin ( fins ) , insulin sensitive index ( isi ) , insulin resistance in - dex ( homa ir ) , insulin secretion index ( homa - ) and autonomic nerve function index ( y value ) before and after treatment in the patients of two groups .", "the efficacy was compared between the two groups .", "the total effective rates were @ % ( @/@ ) and @ % ( @/@ ) in the combined therapy group and the acupuncture group respectively , without significant difference in comparison ( p > @ ) .", "obesity indices , blood lipid indices , fat-islet axie relevant indices and autonomic nerve function indices were all improved after treatment as compared with those before treatment in the two groups ( p < @ , p < @ ) , and the improvements in the combined therapy group were much more significant ( p < @ , p < @ ) .", "the combined therapy of acupuncture and tapping method achieves the double effects of weight loss and lipid loss in the treatment of obesity combined with hyperlipidemia .", "the effect mechanism is possibly related to the positive regulations of blood glucose , lipid metabolism and fat-islet axie in the patients ." ]
to explore the efficacy and effect mechanism of the combined therapy of acupuncture and tapping method in the treatment of obesity and hyperlipidemia of liver qi stagnation and spleen deficiency pattern in the patients . one hundred and four female patients were randomized into a combined therapy of acupuncture and tapping ( combined therapy group ) group method and an acupuncture group , @ cases in each group . in the acupuncture group , acupuncture was applied to qimen ( lr @ ) , taichong ( lr @ ) , zhangmen ( lr @ ) , taibai ( sp @ ) , zusanli ( st @ ) , geshu ( bl @ ) , ganshu ( bl @ ) , pishu ( bl @ ) , etc. . in the combined therapy group , on the basis of acupuncture treatment , the tapping method with plum blossom needle was used at each acupoint . the treatment was given once every two days , continuously for @ months in the two groups . the indices were observed , including the obesity indices , such as body mass , body mass index ( bmi ) , body fat percentage ( f % ) and obesity degree ( a ) ; the blood lipid levels such as total cholesterol ( tc ) , triglyceride ( tg ) , low density lipoprotein ( ldl ) and high density lipoprotein ( hdl ) ; the fat-islet axie relevant indices such as fasting plasma glucose ( fbs ) , fasting leptin ( flp ) , fasting insulin ( fins ) , insulin sensitive index ( isi ) , insulin resistance in - dex ( homa ir ) , insulin secretion index ( homa - ) and autonomic nerve function index ( y value ) before and after treatment in the patients of two groups . the efficacy was compared between the two groups . the total effective rates were @ % ( @/@ ) and @ % ( @/@ ) in the combined therapy group and the acupuncture group respectively , without significant difference in comparison ( p > @ ) . obesity indices , blood lipid indices , fat-islet axie relevant indices and autonomic nerve function indices were all improved after treatment as compared with those before treatment in the two groups ( p < @ , p < @ ) , and the improvements in the combined therapy group were much more significant ( p < @ , p < @ ) . the combined therapy of acupuncture and tapping method achieves the double effects of weight loss and lipid loss in the treatment of obesity combined with hyperlipidemia . the effect mechanism is possibly related to the positive regulations of blood glucose , lipid metabolism and fat-islet axie in the patients .
25,876,338
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "cervical radicular pain is a major cause of disability .", "no studies have been published comparing different types of nonsurgical therapy .", "a comparative-effectiveness study was performed in @ patients with cervical radicular pain less than @ yr in duration .", "participants received nortriptyline and/or gabapentin plus physical therapies , up to three cervical epidural steroid injections ( esi ) or combination treatment over @ months .", "the primary outcome measure was average arm pain on a @ to @ scale at @ month .", "one-month arm pain scores were @ ( @ % ci , @ to @ ) in the combination group , @ ( ci , @ to @ ) in esi patients , and @ ( ci , @ to @ ) in individuals treated conservatively ( p = @ ) .", "combination group patients experienced a mean reduction of -@ ( @ % ci , -@ to -@ ) in average arm pain at @ month versus -@ ( ci , -@ to -@ ) in the conservative group and -@ ( ci , -@ to -@ ) in esi patients ( p = @ ) .", "for neck pain , a mean reduction of -@ ( @ % ci , -@ to -@ ) was noted in combination patients versus -@ ( ci , -@ to -@ ) in conservative group patients and -@ ( ci , -@ to -@ ) in those who received esi ; p = @ ) .", "three-month posttreatment , @ % of patients treated with combination therapy experienced a positive outcome versus @ % in the conservative group and @ % in esi patients ( p = @ ) .", "for the primary outcome measure , no significant differences were found between treatments , although combination therapy provided better improvement than stand-alone treatment on some measures .", "whereas these results suggest an interdisciplinary approach to neck pain may improve outcomes , confirmatory studies are needed ." ]
cervical radicular pain is a major cause of disability . no studies have been published comparing different types of nonsurgical therapy . a comparative-effectiveness study was performed in @ patients with cervical radicular pain less than @ yr in duration . participants received nortriptyline and/or gabapentin plus physical therapies , up to three cervical epidural steroid injections ( esi ) or combination treatment over @ months . the primary outcome measure was average arm pain on a @ to @ scale at @ month . one-month arm pain scores were @ ( @ % ci , @ to @ ) in the combination group , @ ( ci , @ to @ ) in esi patients , and @ ( ci , @ to @ ) in individuals treated conservatively ( p = @ ) . combination group patients experienced a mean reduction of -@ ( @ % ci , -@ to -@ ) in average arm pain at @ month versus -@ ( ci , -@ to -@ ) in the conservative group and -@ ( ci , -@ to -@ ) in esi patients ( p = @ ) . for neck pain , a mean reduction of -@ ( @ % ci , -@ to -@ ) was noted in combination patients versus -@ ( ci , -@ to -@ ) in conservative group patients and -@ ( ci , -@ to -@ ) in those who received esi ; p = @ ) . three-month posttreatment , @ % of patients treated with combination therapy experienced a positive outcome versus @ % in the conservative group and @ % in esi patients ( p = @ ) . for the primary outcome measure , no significant differences were found between treatments , although combination therapy provided better improvement than stand-alone treatment on some measures . whereas these results suggest an interdisciplinary approach to neck pain may improve outcomes , confirmatory studies are needed .
25,335,172
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "this study examines the cost effectiveness of group follow-up after participation in the dose adjustment for normal eating ( dafne ) structured education programme for type @ diabetes .", "economic evaluation conducted alongside a cluster randomised controlled trial involving @ adults with type @ diabetes in ireland .", "group follow-up involved two group education ` booster ' sessions post-dafne .", "individual follow-up involved two standard one-to-one hospital clinic visits .", "incremental costs , quality-adjusted life years ( qalys ) gained and cost effectiveness were estimated at @ months .", "uncertainty was explored using sensitivity analysis and by estimating cost effectiveness acceptability curves .", "group follow-up was associated with a mean reduction in qalys gained of @ per patient ( p value , @ ; @ % ci , -@ to @ , intra-class correlation ( icc ) , @ ) and a mean reduction in total healthcare costs of @ ( p value , @ ; @ % ci , -@,@ to -@ : icc , @ ) per patient .", "at alternative threshold values of @,@ , @,@ , @,@ , @,@ , and @,@ , the probability of group follow-up being cost effective was estimated to be @ , @ , @ , @ , and @ respectively .", "the results do not support implementation of group follow-up as the sole means of follow-up post-dafne .", "given the reported cost savings , future studies should explore the cost effectiveness of alternative models of group care for diabetes .", "current controlled trials isrctn@ ( assigned : @ february @ ) ." ]
this study examines the cost effectiveness of group follow-up after participation in the dose adjustment for normal eating ( dafne ) structured education programme for type @ diabetes . economic evaluation conducted alongside a cluster randomised controlled trial involving @ adults with type @ diabetes in ireland . group follow-up involved two group education ` booster ' sessions post-dafne . individual follow-up involved two standard one-to-one hospital clinic visits . incremental costs , quality-adjusted life years ( qalys ) gained and cost effectiveness were estimated at @ months . uncertainty was explored using sensitivity analysis and by estimating cost effectiveness acceptability curves . group follow-up was associated with a mean reduction in qalys gained of @ per patient ( p value , @ ; @ % ci , -@ to @ , intra-class correlation ( icc ) , @ ) and a mean reduction in total healthcare costs of @ ( p value , @ ; @ % ci , -@,@ to -@ : icc , @ ) per patient . at alternative threshold values of @,@ , @,@ , @,@ , @,@ , and @,@ , the probability of group follow-up being cost effective was estimated to be @ , @ , @ , @ , and @ respectively . the results do not support implementation of group follow-up as the sole means of follow-up post-dafne . given the reported cost savings , future studies should explore the cost effectiveness of alternative models of group care for diabetes . current controlled trials isrctn@ ( assigned : @ february @ ) .
24,927,851
[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "to evaluate and compare the effectiveness of the combined regimen ( consisting of condoms and emergency contraception pills ( ecp ) ) and using condoms only for the purpose of preventing pregnancy .", "one-thousand-five-hundred-and-sixty-two ( @,@ ) couples as volunteers enrolled at nine centers in shanghai .", "eight-hundred-and-twelve ( @ ) were randomized to use male condoms and ecp ( i.e. , levonorgestrel ) as a back-up to condoms ( the intervention group ) and @ to use male condoms only ( the control group ) , according to their working unit .", "participants were visited at admission and at the end of @ , @ , @ , @ , and @ months .", "the cumulative life table rates were calculated for pregnancy and other reasons for discontinuation .", "the gross cumulative life table rates showed that the cumulative discontinuation rates for all reasons during the year of follow-up in the condoms plus emergency contraception group and the condoms only group were @ and @ , respectively , per @ women ( @ = @ , p = @ ) .", "the cumulative gross pregnancy rate of the condoms plus emergency contraception group and the condoms only group were @ and @ , respectively , per @ women ( @ = @ , p = @ ) .", "the pearl index in the condoms plus emergency contraception group and the condoms only group were @ % and @ % , respectively .", "male condoms remain a highly effective contraceptive method for a period of one year while consistently and correctly used .", "in addition , the lowest pregnancy rate followed from perfect use condom ." ]
to evaluate and compare the effectiveness of the combined regimen ( consisting of condoms and emergency contraception pills ( ecp ) ) and using condoms only for the purpose of preventing pregnancy . one-thousand-five-hundred-and-sixty-two ( @,@ ) couples as volunteers enrolled at nine centers in shanghai . eight-hundred-and-twelve ( @ ) were randomized to use male condoms and ecp ( i.e. , levonorgestrel ) as a back-up to condoms ( the intervention group ) and @ to use male condoms only ( the control group ) , according to their working unit . participants were visited at admission and at the end of @ , @ , @ , @ , and @ months . the cumulative life table rates were calculated for pregnancy and other reasons for discontinuation . the gross cumulative life table rates showed that the cumulative discontinuation rates for all reasons during the year of follow-up in the condoms plus emergency contraception group and the condoms only group were @ and @ , respectively , per @ women ( @ = @ , p = @ ) . the cumulative gross pregnancy rate of the condoms plus emergency contraception group and the condoms only group were @ and @ , respectively , per @ women ( @ = @ , p = @ ) . the pearl index in the condoms plus emergency contraception group and the condoms only group were @ % and @ % , respectively . male condoms remain a highly effective contraceptive method for a period of one year while consistently and correctly used . in addition , the lowest pregnancy rate followed from perfect use condom .
24,725,355
[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "comorbid substance related disorders are a major health problem for patients in opioid maintenance treatment ( omt ) .", "it was investigated whether a reinforcement scheme adapted to the regulatory and financial restrictions of routine treatment reduces concomitant drug use .", "omt patients from @ clinics who were using cocaine , benzodiazepines , heroin or amphetamines were randomly allocated to either treatment as usual ( n = @ ) or treatment with an additional escalating reinforcement scheme ( n = @ ) in which a patient 's number of weekly take-home dosages was increased after @ , @ , @ and @ consecutive weeks with drug-free urine specimens .", "trial duration was @ weeks .", "completion rates were @ % for controls and @ % in the experimental group .", "mean number of drug-free weeks was @ ( sd @ ) for the control group and @ ( @ ) for the experimental group ( p = @ ) .", "the intervention was not effective compared to routine treatment .", "additional features might be necessary to achieve an effect , e.g. a higher frequency of urine sampling or use of other reinforcers .", "it has to be further investigated how interventions which have been proven effective in experimental studies can successfully be adapted to routine care conditions ." ]
comorbid substance related disorders are a major health problem for patients in opioid maintenance treatment ( omt ) . it was investigated whether a reinforcement scheme adapted to the regulatory and financial restrictions of routine treatment reduces concomitant drug use . omt patients from @ clinics who were using cocaine , benzodiazepines , heroin or amphetamines were randomly allocated to either treatment as usual ( n = @ ) or treatment with an additional escalating reinforcement scheme ( n = @ ) in which a patient 's number of weekly take-home dosages was increased after @ , @ , @ and @ consecutive weeks with drug-free urine specimens . trial duration was @ weeks . completion rates were @ % for controls and @ % in the experimental group . mean number of drug-free weeks was @ ( sd @ ) for the control group and @ ( @ ) for the experimental group ( p = @ ) . the intervention was not effective compared to routine treatment . additional features might be necessary to achieve an effect , e.g. a higher frequency of urine sampling or use of other reinforcers . it has to be further investigated how interventions which have been proven effective in experimental studies can successfully be adapted to routine care conditions .
24,334,780
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "corticoids have potent anti-inflammatory effects , which may help in relieving pain and dysfunction associated with lumbar canal stenosis .", "we assessed the effectiveness of a decreasing-dose regimen of oral corticoids in the treatment of lumbar canal stenosis in a prospective , double-blind , randomized , placebo-controlled trial .", "sixty-one patients with lumbar canal stenosis ( @-@ years ; canal area < @mm@ at l@/l@ , l@/l@ , and/or l@/s@on magnetic resonance imaging ; and claudication within @m were electronically randomized to an oral corticoid group ( n = @ ) or a placebo group ( n = @ ) .", "the treatment group received @mg/kg of oral corticoids daily , with a dose reduction of one-third per week for @weeks .", "patients and controls were assessed by the short form @ health survey , roland-morris questionnaire , @-min walk test , visual analog scale , and a likert scale .", "all instruments showed similar outcomes for the corticoid and placebo groups ( p > @ ) .", "obese patients exhibited more severe symptoms compared with non-obese patients .", "l@/l@ stenosis was associated with more severe symptoms compared with stenosis at other levels .", "the oral corticoid regimen used in this study was not effective in the treatment of lumbar canal stenosis ." ]
corticoids have potent anti-inflammatory effects , which may help in relieving pain and dysfunction associated with lumbar canal stenosis . we assessed the effectiveness of a decreasing-dose regimen of oral corticoids in the treatment of lumbar canal stenosis in a prospective , double-blind , randomized , placebo-controlled trial . sixty-one patients with lumbar canal stenosis ( @-@ years ; canal area < @mm@ at l@/l@ , l@/l@ , and/or l@/s@on magnetic resonance imaging ; and claudication within @m were electronically randomized to an oral corticoid group ( n = @ ) or a placebo group ( n = @ ) . the treatment group received @mg/kg of oral corticoids daily , with a dose reduction of one-third per week for @weeks . patients and controls were assessed by the short form @ health survey , roland-morris questionnaire , @-min walk test , visual analog scale , and a likert scale . all instruments showed similar outcomes for the corticoid and placebo groups ( p > @ ) . obese patients exhibited more severe symptoms compared with non-obese patients . l@/l@ stenosis was associated with more severe symptoms compared with stenosis at other levels . the oral corticoid regimen used in this study was not effective in the treatment of lumbar canal stenosis .
25,099,318
[ "BACKGROUND", "BACKGROUND", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "use of hypotonic intravenous fluid to maintain hydration in children in hospital has been associated with hyponatraemia , leading to neurological morbidity and mortality .", "we aimed to assess whether use of fluid solutions with a higher sodium concentration reduced the risk of hyponatraemia compared with use of hypotonic solutions .", "we did a randomised controlled double-blind trial of children admitted to the royal children 's hospital ( melbourne , vic , australia ) who needed intravenous maintenance hydration for @ h or longer .", "with an online randomisation system that used unequal block sizes , we randomly assigned patients ( @:@ ) to receive either isotonic intravenous fluid containing @ mmol/l of sodium ( na@ ) or hypotonic fluid containing @ mmol/l of sodium ( na@ ) for @ h or until their intravenous fluid rate decreased to lower than @ % of the standard maintenance rate .", "we stratified assignment by baseline sodium concentrations .", "study investigators , treating clinicians , nurses , and patients were masked to treatment assignment .", "the primary outcome was occurrence of hyponatraemia ( serum sodium concentration < @ mmol/l with a decrease of at least @ mmol/l from baseline ) during the treatment period , analysed by intention to treat .", "the trial was registered with the australian new zealand clinical trials registry , number actrn@ .", "between feb @ , @ , and jan @ , @ , we randomly assigned @ patients .", "of these patients , primary outcome data were available for @ who received na@ and @ who received na@ .", "fewer patients given na@ than those given na@ developed hyponatraemia ( @ patients -lsb- @ % -rsb- vs @ -lsb- @ % -rsb- ; odds ratio -lsb- or -rsb- @ , @ % ci @-@ ; p = @ ) .", "no clinically apparent cerebral oedema occurred in either group .", "eight patients in the na@ group ( two potentially related to intravenous fluid ) and four in the na@ group ( none related to intravenous fluid ) developed serious adverse events during the treatment period .", "one patient in the na@ had seizures during the treatment period compared with seven who received na@ .", "use of isotonic intravenous fluid with a sodium concentration of @ mmol/l had a lower risk of hyponatraemia without an increase in adverse effects than did fluid containing @ mmol/l of sodium .", "an isotonic fluid should be used as intravenous fluid for maintenance hydration in children .", "national health and medical research council , murdoch childrens research institute , the royal children 's hospital , and the australian and new zealand college of anaesthetists ." ]
use of hypotonic intravenous fluid to maintain hydration in children in hospital has been associated with hyponatraemia , leading to neurological morbidity and mortality . we aimed to assess whether use of fluid solutions with a higher sodium concentration reduced the risk of hyponatraemia compared with use of hypotonic solutions . we did a randomised controlled double-blind trial of children admitted to the royal children 's hospital ( melbourne , vic , australia ) who needed intravenous maintenance hydration for @ h or longer . with an online randomisation system that used unequal block sizes , we randomly assigned patients ( @:@ ) to receive either isotonic intravenous fluid containing @ mmol/l of sodium ( na@ ) or hypotonic fluid containing @ mmol/l of sodium ( na@ ) for @ h or until their intravenous fluid rate decreased to lower than @ % of the standard maintenance rate . we stratified assignment by baseline sodium concentrations . study investigators , treating clinicians , nurses , and patients were masked to treatment assignment . the primary outcome was occurrence of hyponatraemia ( serum sodium concentration < @ mmol/l with a decrease of at least @ mmol/l from baseline ) during the treatment period , analysed by intention to treat . the trial was registered with the australian new zealand clinical trials registry , number actrn@ . between feb @ , @ , and jan @ , @ , we randomly assigned @ patients . of these patients , primary outcome data were available for @ who received na@ and @ who received na@ . fewer patients given na@ than those given na@ developed hyponatraemia ( @ patients -lsb- @ % -rsb- vs @ -lsb- @ % -rsb- ; odds ratio -lsb- or -rsb- @ , @ % ci @-@ ; p = @ ) . no clinically apparent cerebral oedema occurred in either group . eight patients in the na@ group ( two potentially related to intravenous fluid ) and four in the na@ group ( none related to intravenous fluid ) developed serious adverse events during the treatment period . one patient in the na@ had seizures during the treatment period compared with seven who received na@ . use of isotonic intravenous fluid with a sodium concentration of @ mmol/l had a lower risk of hyponatraemia without an increase in adverse effects than did fluid containing @ mmol/l of sodium . an isotonic fluid should be used as intravenous fluid for maintenance hydration in children . national health and medical research council , murdoch childrens research institute , the royal children 's hospital , and the australian and new zealand college of anaesthetists .
25,472,864
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "in a phase @ study , the inhibition of the interleukin-@a receptor improved signs and symptoms of psoriatic arthritis .", "we sought to evaluate the efficacy and safety of secukinumab , an anti-interleukin-@a monoclonal antibody , in such patients .", "in this double-blind , phase @ study , @ patients with psoriatic arthritis were randomly assigned in a @:@:@ ratio to receive intravenous secukinumab ( at a dose of @ mg per kilogram ) at weeks @ , @ , and @ , followed by subcutaneous secukinumab at a dose of either @ mg or @ mg every @ weeks , or placebo .", "patients in the placebo group were switched to subcutaneous secukinumab at a dose of @ mg or @ mg at week @ or @ , depending on clinical response .", "the primary end point was the proportion of patients with an american college of rheumatology @ ( acr@ ) response at week @ , defined as a @ % improvement from baseline in the number of tender and swollen joints and at least three other important domains .", "acr@ response rates at week @ were significantly higher in the group receiving secukinumab at doses of @ mg ( @ % ) and @ mg ( @ % ) than in those receiving placebo ( @ % ) ( p < @ for both comparisons with placebo ) .", "secondary end points , including the acr@ response and joint structural damage , were significantly better in the secukinumab groups than in the placebo group .", "improvements were sustained through @ weeks .", "infections , including candida , were more common in the secukinumab groups .", "throughout the study ( mean secukinumab exposure , @ days ; mean placebo exposure , @ days ) , four patients in the secukinumab groups had a stroke ( @ per @ patient-years ; @ % confidence interval -lsb- ci -rsb- , @ to @ ) , and two had a myocardial infarction ( @ per @ patient-years ; @ % ci , @ to @ ) , as compared with no patients in the placebo group .", "secukinumab was more effective than placebo in patients with psoriatic arthritis , which validates interleukin-@a as a therapeutic target .", "infections were more common in the secukinumab groups than in the placebo group .", "the study was neither large enough nor long enough to evaluate uncommon serious adverse events or the risks associated with long-term use .", "( funded by novartis pharma ; clinicaltrials.gov number , nct@ . )" ]
in a phase @ study , the inhibition of the interleukin-@a receptor improved signs and symptoms of psoriatic arthritis . we sought to evaluate the efficacy and safety of secukinumab , an anti-interleukin-@a monoclonal antibody , in such patients . in this double-blind , phase @ study , @ patients with psoriatic arthritis were randomly assigned in a @:@:@ ratio to receive intravenous secukinumab ( at a dose of @ mg per kilogram ) at weeks @ , @ , and @ , followed by subcutaneous secukinumab at a dose of either @ mg or @ mg every @ weeks , or placebo . patients in the placebo group were switched to subcutaneous secukinumab at a dose of @ mg or @ mg at week @ or @ , depending on clinical response . the primary end point was the proportion of patients with an american college of rheumatology @ ( acr@ ) response at week @ , defined as a @ % improvement from baseline in the number of tender and swollen joints and at least three other important domains . acr@ response rates at week @ were significantly higher in the group receiving secukinumab at doses of @ mg ( @ % ) and @ mg ( @ % ) than in those receiving placebo ( @ % ) ( p < @ for both comparisons with placebo ) . secondary end points , including the acr@ response and joint structural damage , were significantly better in the secukinumab groups than in the placebo group . improvements were sustained through @ weeks . infections , including candida , were more common in the secukinumab groups . throughout the study ( mean secukinumab exposure , @ days ; mean placebo exposure , @ days ) , four patients in the secukinumab groups had a stroke ( @ per @ patient-years ; @ % confidence interval -lsb- ci -rsb- , @ to @ ) , and two had a myocardial infarction ( @ per @ patient-years ; @ % ci , @ to @ ) , as compared with no patients in the placebo group . secukinumab was more effective than placebo in patients with psoriatic arthritis , which validates interleukin-@a as a therapeutic target . infections were more common in the secukinumab groups than in the placebo group . the study was neither large enough nor long enough to evaluate uncommon serious adverse events or the risks associated with long-term use . ( funded by novartis pharma ; clinicaltrials.gov number , nct@ . )
26,422,723
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "does substituting @ g corifollitropin alfa for @ iu follitropin beta during the first @ days of ovarian stimulation in proven poor responders , result in retrieval of a non-inferior number ( < @ fewer ) of cumulus oocyte complexes ( cocs ) ?", "a single s.c. dose of @ g corifollitropin alfa on the first day of ovarian stimulation , followed if necessary , from day @ onwards , with @ iu of follitropin beta/day , is not inferior to daily doses of @ iu follitropin beta .", "the @ % ci of the difference between medians in the number of oocytes retrieved was -@ to +@ within the safety margin of @ .", "recent data from retrospective studies suggest that the use of corifollitropin alfa in poor responders is promising since it could simplify ovarian stimulation without compromising its outcome .", "seventy-nine women with previous poor ovarian response undergoing icsi treatment were enrolled in this open label , non-inferiority , randomized clinical trial ( rct ) .", "inclusion criteria were : previous poor response to ovarian stimulation ( @ cocs ) after maximal stimulation , age < @ years , regular spontaneous menstrual cycle , body mass index : @-@ kg/m ( @ ) and basal follicle stimulating hormone @ iu/l .", "on day @ of the menstrual cycle , patients were administered either a single s.c dose of @ g corifollitropin alfa ( n = @ ) or a fixed daily dose of @ iu of follitropin beta ( n = @ ) .", "in the corifollitropin alfa group , @ iu of follitropin beta were administered from day @ of stimulation until the day of human chorionic gonadotrophin ( hcg ) administration , if necessary .", "to inhibit premature luteinizing hormone surge , the gonadotrophin releasing hormone antagonist ganirelix was used .", "triggering of final oocyte maturation was performed using @ g of recombinant hcg , when at least two follicles reached @ mm in mean diameter .", "the number of cocs retrieved was not statistically different between the corifollitropin alfa and the follitropin beta groups -lsb- median @ versus @ , @ % ci @-@ , @-@ , respectively , p = @ -rsb- .", "the @ % ci of the difference between medians in the number of oocytes retrieved was -@ to +@ .", "a multivariable analysis adjusting for all the potential baseline differences confirmed this finding .", "no significant difference was observed regarding the probability of live birth between the corifollitropin alfa and the follitropin beta group ( live birth per patient reaching oocyte retrieval : @ versus @ % , respectively , difference +@ % , @ % ci : -@ to +@ ) .", "the present study was not powered to test a smaller difference ( e.g. @ coc ) in terms of cocs retrieved as well as to show potential differences in the probability of pregnancy .", "moreover , it would be interesting to assess whether the continuation of stimulation in the long acting fsh arm , where necessary , with @ iu instead of @ iu of follitropin beta would have altered the direction or the magnitude of the effect of the type of fsh , observed on the number of cocs retrieved .", "corifollitropin alfa simplifies ivf treatment because it is administered in a gnrh antagonist protocol and replaces seven daily fsh injections with a single one of a long acting fsh without compromising the outcome .", "it could greatly reduce the burden of treatment for poor responders and this deserves further investigation ." ]
does substituting @ g corifollitropin alfa for @ iu follitropin beta during the first @ days of ovarian stimulation in proven poor responders , result in retrieval of a non-inferior number ( < @ fewer ) of cumulus oocyte complexes ( cocs ) ? a single s.c. dose of @ g corifollitropin alfa on the first day of ovarian stimulation , followed if necessary , from day @ onwards , with @ iu of follitropin beta/day , is not inferior to daily doses of @ iu follitropin beta . the @ % ci of the difference between medians in the number of oocytes retrieved was -@ to +@ within the safety margin of @ . recent data from retrospective studies suggest that the use of corifollitropin alfa in poor responders is promising since it could simplify ovarian stimulation without compromising its outcome . seventy-nine women with previous poor ovarian response undergoing icsi treatment were enrolled in this open label , non-inferiority , randomized clinical trial ( rct ) . inclusion criteria were : previous poor response to ovarian stimulation ( @ cocs ) after maximal stimulation , age < @ years , regular spontaneous menstrual cycle , body mass index : @-@ kg/m ( @ ) and basal follicle stimulating hormone @ iu/l . on day @ of the menstrual cycle , patients were administered either a single s.c dose of @ g corifollitropin alfa ( n = @ ) or a fixed daily dose of @ iu of follitropin beta ( n = @ ) . in the corifollitropin alfa group , @ iu of follitropin beta were administered from day @ of stimulation until the day of human chorionic gonadotrophin ( hcg ) administration , if necessary . to inhibit premature luteinizing hormone surge , the gonadotrophin releasing hormone antagonist ganirelix was used . triggering of final oocyte maturation was performed using @ g of recombinant hcg , when at least two follicles reached @ mm in mean diameter . the number of cocs retrieved was not statistically different between the corifollitropin alfa and the follitropin beta groups -lsb- median @ versus @ , @ % ci @-@ , @-@ , respectively , p = @ -rsb- . the @ % ci of the difference between medians in the number of oocytes retrieved was -@ to +@ . a multivariable analysis adjusting for all the potential baseline differences confirmed this finding . no significant difference was observed regarding the probability of live birth between the corifollitropin alfa and the follitropin beta group ( live birth per patient reaching oocyte retrieval : @ versus @ % , respectively , difference +@ % , @ % ci : -@ to +@ ) . the present study was not powered to test a smaller difference ( e.g. @ coc ) in terms of cocs retrieved as well as to show potential differences in the probability of pregnancy . moreover , it would be interesting to assess whether the continuation of stimulation in the long acting fsh arm , where necessary , with @ iu instead of @ iu of follitropin beta would have altered the direction or the magnitude of the effect of the type of fsh , observed on the number of cocs retrieved . corifollitropin alfa simplifies ivf treatment because it is administered in a gnrh antagonist protocol and replaces seven daily fsh injections with a single one of a long acting fsh without compromising the outcome . it could greatly reduce the burden of treatment for poor responders and this deserves further investigation .
25,492,411
[ "OBJECTIVE", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "recently , a number of studies using intra-articular application of tranexamic acid ( ia-txa ) , with different dosage and techniques , successfully reduced postoperative blood loss in total knee replacement ( tkr ) .", "however , best of our knowledge , the very low dose of ia-txa with drain clamping technique in conventional tkr has not been yet studied .", "this study aimed to evaluate the effectiveness and dose-response effect of two low-dose ia-txa regimens in conventional tkr on blood loss and blood transfusion reduction .", "between @ and @ , a triple-blinded randomized controlled study was conducted in @ patients undergoing conventional tkr .", "the patients were allocated into three groups according to intra-articular solution received : control group ( physiologic saline ) , txa-@ group ( txa @ mg ) , and txa-@ group ( txa @ mg ) .", "the solution was injected after wound closure followed by drain clamping for @ hours .", "blood loss and transfusion were recorded .", "duplex ultrasound was performed .", "functional outcome and complication were followed for one year .", "there were forty-five patients per groups .", "the mean total hemoglobin loss was @ g/dl in control group compared with @ g/dl in both txa groups ( p > @ ) .", "ten patients ( @ % , control ) , six patients ( @ % , txa-@ ) and none ( txa-@ ) required transfusion ( p = @ ) .", "thromboembolic events were detected in @ patients ( @ controls , @ txa-@ , and @ txa-@ ) .", "functional outcome was non-significant difference between groups .", "combined low-dose ia-txa , as @ mg , with @-hour clamp drain is effective for reducing postoperative blood loss and transfusion in conventional tkr without significant difference in postoperative knee function or complication .", "clinicaltrials.gov nct@ ." ]
recently , a number of studies using intra-articular application of tranexamic acid ( ia-txa ) , with different dosage and techniques , successfully reduced postoperative blood loss in total knee replacement ( tkr ) . however , best of our knowledge , the very low dose of ia-txa with drain clamping technique in conventional tkr has not been yet studied . this study aimed to evaluate the effectiveness and dose-response effect of two low-dose ia-txa regimens in conventional tkr on blood loss and blood transfusion reduction . between @ and @ , a triple-blinded randomized controlled study was conducted in @ patients undergoing conventional tkr . the patients were allocated into three groups according to intra-articular solution received : control group ( physiologic saline ) , txa-@ group ( txa @ mg ) , and txa-@ group ( txa @ mg ) . the solution was injected after wound closure followed by drain clamping for @ hours . blood loss and transfusion were recorded . duplex ultrasound was performed . functional outcome and complication were followed for one year . there were forty-five patients per groups . the mean total hemoglobin loss was @ g/dl in control group compared with @ g/dl in both txa groups ( p > @ ) . ten patients ( @ % , control ) , six patients ( @ % , txa-@ ) and none ( txa-@ ) required transfusion ( p = @ ) . thromboembolic events were detected in @ patients ( @ controls , @ txa-@ , and @ txa-@ ) . functional outcome was non-significant difference between groups . combined low-dose ia-txa , as @ mg , with @-hour clamp drain is effective for reducing postoperative blood loss and transfusion in conventional tkr without significant difference in postoperative knee function or complication . clinicaltrials.gov nct@ .
24,308,672
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]
[ "although previous studies have suggested the potential advantages of albumin administration in patients with severe sepsis , its efficacy has not been fully established .", "in this multicenter , open-label trial , we randomly assigned @ patients with severe sepsis , in @ intensive care units ( icus ) , to receive either @ % albumin and crystalloid solution or crystalloid solution alone .", "in the albumin group , the target serum albumin concentration was @ g per liter or more until discharge from the icu or @ days after randomization .", "the primary outcome was death from any cause at @ days .", "secondary outcomes were death from any cause at @ days , the number of patients with organ dysfunction and the degree of dysfunction , and length of stay in the icu and the hospital .", "during the first @ days , patients in the albumin group , as compared with those in the crystalloid group , had a higher mean arterial pressure ( p = @ ) and lower net fluid balance ( p < @ ) .", "the total daily amount of administered fluid did not differ significantly between the two groups ( p = @ ) .", "at @ days , @ of @ patients ( @ % ) in the albumin group and @ of @ ( @ % ) in the crystalloid group had died ( relative risk in the albumin group , @ ; @ % confidence interval -lsb- ci -rsb- , @ to @ ; p = @ ) .", "at @ days , @ of @ patients ( @ % ) in the albumin group and @ of @ ( @ % ) in the crystalloid group had died ( relative risk , @ ; @ % ci , @ to @ ; p = @ ) .", "no significant differences in other secondary outcomes were observed between the two groups .", "in patients with severe sepsis , albumin replacement in addition to crystalloids , as compared with crystalloids alone , did not improve the rate of survival at @ and @ days .", "( funded by the italian medicines agency ; albios clinicaltrials.gov number , nct@ . )" ]
although previous studies have suggested the potential advantages of albumin administration in patients with severe sepsis , its efficacy has not been fully established . in this multicenter , open-label trial , we randomly assigned @ patients with severe sepsis , in @ intensive care units ( icus ) , to receive either @ % albumin and crystalloid solution or crystalloid solution alone . in the albumin group , the target serum albumin concentration was @ g per liter or more until discharge from the icu or @ days after randomization . the primary outcome was death from any cause at @ days . secondary outcomes were death from any cause at @ days , the number of patients with organ dysfunction and the degree of dysfunction , and length of stay in the icu and the hospital . during the first @ days , patients in the albumin group , as compared with those in the crystalloid group , had a higher mean arterial pressure ( p = @ ) and lower net fluid balance ( p < @ ) . the total daily amount of administered fluid did not differ significantly between the two groups ( p = @ ) . at @ days , @ of @ patients ( @ % ) in the albumin group and @ of @ ( @ % ) in the crystalloid group had died ( relative risk in the albumin group , @ ; @ % confidence interval -lsb- ci -rsb- , @ to @ ; p = @ ) . at @ days , @ of @ patients ( @ % ) in the albumin group and @ of @ ( @ % ) in the crystalloid group had died ( relative risk , @ ; @ % ci , @ to @ ; p = @ ) . no significant differences in other secondary outcomes were observed between the two groups . in patients with severe sepsis , albumin replacement in addition to crystalloids , as compared with crystalloids alone , did not improve the rate of survival at @ and @ days . ( funded by the italian medicines agency ; albios clinicaltrials.gov number , nct@ . )
24,635,772
[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to assess the most effective local analgesia during transrectal ultrasound-guided prostate biopsy .", "a total of @ consecutive patients undergoing transrectal ultrasound-guided prostate biopsy for elevated prostate-specific antigen levels and/or a suspicious digital rectal examination were randomized to three groups .", "patients received a @-mg lidocaine suppository ( group @ , n = @ ) , a periprostatic nerve block ( @-ml injection of lidocaine hydrochloride ; group @ , n = @ ) or a combination of both ( group @ , n = @ ) before a @-core transrectal ultrasound-guided biopsy .", "a total of @ % ( n = @ ) of the patients underwent their first biopsy , @ % ( n = @ ) their second and @ % ( n = @ ) the third .", "pain was evaluated on a @-point visual analog scale for each step of the procedure .", "prostate-specific antigen values ranged from @ to @ ( mean -lsb- sd -rsb- @ ng/ml -lsb- @ ng/ml -rsb- ) .", "comparison of the median visual analog scale scores between groups @ and @ showed a significant difference ( p = @ ) .", "the differences in the outcomes between groups @ and @ ( p = @ ) , and groups @ and @ ( p = @ ) were also significant .", "patients of group @ had the best output corresponding to the pain sensations and therefore the lowest visual analog scale scores .", "the combination of lidocaine suppository and periprostatic lidocaine infiltration is more effective for pain control than either lidocaine suppository or periprostatic lidocaine infiltration alone in patients undergoing transrectal ultrasound-guided prostate biopsy ." ]
to assess the most effective local analgesia during transrectal ultrasound-guided prostate biopsy . a total of @ consecutive patients undergoing transrectal ultrasound-guided prostate biopsy for elevated prostate-specific antigen levels and/or a suspicious digital rectal examination were randomized to three groups . patients received a @-mg lidocaine suppository ( group @ , n = @ ) , a periprostatic nerve block ( @-ml injection of lidocaine hydrochloride ; group @ , n = @ ) or a combination of both ( group @ , n = @ ) before a @-core transrectal ultrasound-guided biopsy . a total of @ % ( n = @ ) of the patients underwent their first biopsy , @ % ( n = @ ) their second and @ % ( n = @ ) the third . pain was evaluated on a @-point visual analog scale for each step of the procedure . prostate-specific antigen values ranged from @ to @ ( mean -lsb- sd -rsb- @ ng/ml -lsb- @ ng/ml -rsb- ) . comparison of the median visual analog scale scores between groups @ and @ showed a significant difference ( p = @ ) . the differences in the outcomes between groups @ and @ ( p = @ ) , and groups @ and @ ( p = @ ) were also significant . patients of group @ had the best output corresponding to the pain sensations and therefore the lowest visual analog scale scores . the combination of lidocaine suppository and periprostatic lidocaine infiltration is more effective for pain control than either lidocaine suppository or periprostatic lidocaine infiltration alone in patients undergoing transrectal ultrasound-guided prostate biopsy .
24,974,854
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "we hypothesized that arthroscopic rotator cuff repairs using leukocyte - and platelet-rich fibrin ( l-prf ) in a standardized , modified protocol is technically feasible and results in a higher vascularization response and watertight healing rate during early healing .", "twenty patients with chronic rotator cuff tears were randomly assigned to @ treatment groups .", "in the test group ( n = @ ) , l-prf was added in between the tendon and the bone during arthroscopic rotator cuff repair .", "the second group served as control ( n = @ ) .", "they received the same arthroscopic treatment without the use of l-prf .", "we used a double-row tension band technique .", "clinical examinations including subjective shoulder value , visual analog scale , constant , and simple shoulder test scores and measurement of the vascularization with power doppler ultrasonography were made at @ and @ weeks .", "there have been no postoperative complications .", "at @ and @ weeks , there was no significant difference in the clinical scores between the test and the control groups .", "the mean vascularization index of the surgical tendon-to-bone insertions was always significantly higher in the l-prf group than in the contralateral healthy shoulders at @ and @ weeks ( p = @ ) .", "whereas the l-prf group showed a higher vascularization compared with the control group at @ weeks ( p = @ ) , there was no difference after @ weeks of follow-up ( p = @ ) .", "watertight healing was obtained in @ % of the repaired cuffs .", "arthroscopic rotator cuff repair with the application of l-prf is technically feasible and yields higher early vascularization .", "increased vascularization may potentially predispose to an increased and earlier cellular response and an increased healing rate ." ]
we hypothesized that arthroscopic rotator cuff repairs using leukocyte - and platelet-rich fibrin ( l-prf ) in a standardized , modified protocol is technically feasible and results in a higher vascularization response and watertight healing rate during early healing . twenty patients with chronic rotator cuff tears were randomly assigned to @ treatment groups . in the test group ( n = @ ) , l-prf was added in between the tendon and the bone during arthroscopic rotator cuff repair . the second group served as control ( n = @ ) . they received the same arthroscopic treatment without the use of l-prf . we used a double-row tension band technique . clinical examinations including subjective shoulder value , visual analog scale , constant , and simple shoulder test scores and measurement of the vascularization with power doppler ultrasonography were made at @ and @ weeks . there have been no postoperative complications . at @ and @ weeks , there was no significant difference in the clinical scores between the test and the control groups . the mean vascularization index of the surgical tendon-to-bone insertions was always significantly higher in the l-prf group than in the contralateral healthy shoulders at @ and @ weeks ( p = @ ) . whereas the l-prf group showed a higher vascularization compared with the control group at @ weeks ( p = @ ) , there was no difference after @ weeks of follow-up ( p = @ ) . watertight healing was obtained in @ % of the repaired cuffs . arthroscopic rotator cuff repair with the application of l-prf is technically feasible and yields higher early vascularization . increased vascularization may potentially predispose to an increased and earlier cellular response and an increased healing rate .
24,331,121
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the measurement of mechanosensitivity is a key method for the study of pain in animal models .", "this is often accomplished with the use of von frey filaments in an up-down testing paradigm .", "the up-down method described by chaplan et al. ( j neurosci methods @:@ -@ , @ ) for mechanosensitivity testing in rodents remains one of the most widely used methods for measuring pain in animals .", "however , this method results in animals receiving a varying number of stimuli , which may lead to animals in different groups receiving different testing experiences that influences their later responses .", "to standardize the measurement of mechanosensitivity we developed a simplified up-down method ( sudo ) for estimating paw withdrawal threshold ( pwt ) with von frey filaments that uses a constant number of five stimuli per test .", "we further refined the pwt calculation to allow the estimation of pwt directly from the behavioral response to the fifth stimulus , omitting the need for look-up tables .", "the pwt estimates derived using sudo strongly correlated ( r > @ ) with the pwt estimates determined with the conventional up-down method of chaplan et al. , and this correlation remained very strong across different levels of tester experience , different experimental conditions , and in tests from both mice and rats .", "the two testing methods also produced similar pwt estimates in prospective behavioral tests of mice at baseline and after induction of hyperalgesia by intraplantar capsaicin or complete freund 's adjuvant .", "sudo thus offers an accurate , fast and user-friendly replacement for the widely used up-down method of chaplan et al. ." ]
the measurement of mechanosensitivity is a key method for the study of pain in animal models . this is often accomplished with the use of von frey filaments in an up-down testing paradigm . the up-down method described by chaplan et al. ( j neurosci methods @:@ -@ , @ ) for mechanosensitivity testing in rodents remains one of the most widely used methods for measuring pain in animals . however , this method results in animals receiving a varying number of stimuli , which may lead to animals in different groups receiving different testing experiences that influences their later responses . to standardize the measurement of mechanosensitivity we developed a simplified up-down method ( sudo ) for estimating paw withdrawal threshold ( pwt ) with von frey filaments that uses a constant number of five stimuli per test . we further refined the pwt calculation to allow the estimation of pwt directly from the behavioral response to the fifth stimulus , omitting the need for look-up tables . the pwt estimates derived using sudo strongly correlated ( r > @ ) with the pwt estimates determined with the conventional up-down method of chaplan et al. , and this correlation remained very strong across different levels of tester experience , different experimental conditions , and in tests from both mice and rats . the two testing methods also produced similar pwt estimates in prospective behavioral tests of mice at baseline and after induction of hyperalgesia by intraplantar capsaicin or complete freund 's adjuvant . sudo thus offers an accurate , fast and user-friendly replacement for the widely used up-down method of chaplan et al. .
24,739,328
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "it is unclear if holding angiotensin-converting enzyme inhibitors ( acei ) or angiotensin receptor blockers ( arb ) prior to coronary angiography reduces contrast-induced acute kidney injury ( aki ) .", "we undertook a randomized trial to investigate the effect of holding acei/arb therapy prior to coronary angiography on the incidence of aki .", "we randomly assigned @ patients with moderate renal insufficiency ( creatinine @ mg/dl within @ months and/or documented creatinine @ mg/dl within @ week before cardiac catheterization ) to hold acei/arb @ hours preprocedure or continue acei/arb .", "the primary outcome was the incidence of aki defined as an absolute rise in serum creatinine of @ mg/dl from baseline and/or a relative rise in serum creatinine of @ % compared with baseline measured at @ to @ hours postcardiac catheterization .", "all patients were taking an acei ( @ % ) or arb ( @ % ) prior to randomization .", "at @ to @ hours , the primary outcome occurred in @ % of patients who continued acei/arb compared with @ % of the patients who held acei/arb ( hazard ratio @ , @ % ci @-@ @ , p = @ ) .", "in a prespecified secondary outcome , there was a lower rise in mean serum creatinine after the procedure in patients who held acei/arb ( @ @ vs @ @ mg/dl , p = @ ) .", "the clinical composite of death , myocardial infarction , ischemic stroke , congestive heart failure , rehospitalization for cardiovascular cause , or need for dialysis preprocedure occurred in @ % who continued acei/arb compared with @ % who held the acei/arb ( hazard ratio @ , @ % ci @-@ @ , p = @ ) .", "in this pilot study of patients with moderate renal insufficiency undergoing cardiac catheterization , with-holding acei/arb resulted in a non-significant reduction in contrast-induced aki and a significant reduction in post-procedural rise of creatinine .", "this low cost intervention could be considered when referring a patient for cardiac catheterization ." ]
it is unclear if holding angiotensin-converting enzyme inhibitors ( acei ) or angiotensin receptor blockers ( arb ) prior to coronary angiography reduces contrast-induced acute kidney injury ( aki ) . we undertook a randomized trial to investigate the effect of holding acei/arb therapy prior to coronary angiography on the incidence of aki . we randomly assigned @ patients with moderate renal insufficiency ( creatinine @ mg/dl within @ months and/or documented creatinine @ mg/dl within @ week before cardiac catheterization ) to hold acei/arb @ hours preprocedure or continue acei/arb . the primary outcome was the incidence of aki defined as an absolute rise in serum creatinine of @ mg/dl from baseline and/or a relative rise in serum creatinine of @ % compared with baseline measured at @ to @ hours postcardiac catheterization . all patients were taking an acei ( @ % ) or arb ( @ % ) prior to randomization . at @ to @ hours , the primary outcome occurred in @ % of patients who continued acei/arb compared with @ % of the patients who held acei/arb ( hazard ratio @ , @ % ci @-@ @ , p = @ ) . in a prespecified secondary outcome , there was a lower rise in mean serum creatinine after the procedure in patients who held acei/arb ( @ @ vs @ @ mg/dl , p = @ ) . the clinical composite of death , myocardial infarction , ischemic stroke , congestive heart failure , rehospitalization for cardiovascular cause , or need for dialysis preprocedure occurred in @ % who continued acei/arb compared with @ % who held the acei/arb ( hazard ratio @ , @ % ci @-@ @ , p = @ ) . in this pilot study of patients with moderate renal insufficiency undergoing cardiac catheterization , with-holding acei/arb resulted in a non-significant reduction in contrast-induced aki and a significant reduction in post-procedural rise of creatinine . this low cost intervention could be considered when referring a patient for cardiac catheterization .
26,093,871
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "few studies have evaluated the possible beneficial effect of the administration of stem cells in the early stages of stroke .", "intravenous administration of allogeneic mesenchymal stem cells ( mscs ) from adipose tissue in patients with acute stroke could be a safe therapy for promoting neurovascular unit repair , consequently supporting better functional recovery .", "we aim to assess the safety and efficacy of msc administration and evaluate its potential as a treatment for cerebral protection and repair .", "a phase iia , prospective , randomized , double-blind , placebo-controlled , single-center , pilot clinical trial .", "twenty patients presenting acute ischemic stroke will be randomized in a @:@ proportion to treatment with allogeneic mscs from adipose tissue or to placebo ( or vehicle ) administered as a single intravenous dose within the first @ weeks after the onset of stroke symptoms .", "the patients will be followed up for @ years .", "primary outcomes for safety analysis : adverse events ( aes ) and serious aes ; neurologic and systemic complications , and tumor development .", "secondary outcomes for efficacy analysis : modified rankin scale ; nihss ; infarct size ; and biochemical markers of brain repair ( vascular endothelial growth factor , brain-derived neurotrophic factor , and matrix metalloproteinases @ ) .", "to our knowledge , this is the first , phase ii , pilot clinical trial to investigate the safety and efficacy of intravenous administration of allogeneic mscs from adipose tissue within the first @ weeks of stroke .", "in addition , its results will help us define the best criteria for a future phase iii study ." ]
few studies have evaluated the possible beneficial effect of the administration of stem cells in the early stages of stroke . intravenous administration of allogeneic mesenchymal stem cells ( mscs ) from adipose tissue in patients with acute stroke could be a safe therapy for promoting neurovascular unit repair , consequently supporting better functional recovery . we aim to assess the safety and efficacy of msc administration and evaluate its potential as a treatment for cerebral protection and repair . a phase iia , prospective , randomized , double-blind , placebo-controlled , single-center , pilot clinical trial . twenty patients presenting acute ischemic stroke will be randomized in a @:@ proportion to treatment with allogeneic mscs from adipose tissue or to placebo ( or vehicle ) administered as a single intravenous dose within the first @ weeks after the onset of stroke symptoms . the patients will be followed up for @ years . primary outcomes for safety analysis : adverse events ( aes ) and serious aes ; neurologic and systemic complications , and tumor development . secondary outcomes for efficacy analysis : modified rankin scale ; nihss ; infarct size ; and biochemical markers of brain repair ( vascular endothelial growth factor , brain-derived neurotrophic factor , and matrix metalloproteinases @ ) . to our knowledge , this is the first , phase ii , pilot clinical trial to investigate the safety and efficacy of intravenous administration of allogeneic mscs from adipose tissue within the first @ weeks of stroke . in addition , its results will help us define the best criteria for a future phase iii study .
25,304,723
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "this international phase iii trial ( investigating torisel as second-line therapy -lsb- intorsect -rsb- ) compared the efficacy of temsirolimus ( mammalian target of rapamycin inhibitor ) and sorafenib ( vascular endothelial growth factor receptor -lsb- vegfr -rsb- tyrosine kinase inhibitor ) as second-line therapy in patients with metastatic renal cell carcinoma ( mrcc ) after disease progression on sunitinib .", "in total , @ patients were randomly assigned @:@ to receive intravenous temsirolimus @ mg once weekly ( n = @ ) or oral sorafenib @ mg twice per day ( n = @ ) , with stratification according to duration of prior sunitinib therapy ( or > @ days ) , prognostic risk , histology ( clear cell or non-clear cell ) , and nephrectomy status .", "the primary end point was progression-free survival ( pfs ) by independent review committee assessment .", "safety , objective response rate ( orr ) , and overall survival ( os ) were secondary end points .", "primary analysis revealed no significant difference between treatment arms for pfs ( stratified hazard ratio -lsb- hr -rsb- , @ ; @ % ci , @ to @ ; two-sided p = @ ) or orr .", "median pfs in the temsirolimus and sorafenib arms were @ and @ months , respectively .", "there was a significant os difference in favor of sorafenib ( stratified hr , @ ; @ % ci , @ to @ ; two-sided p = @ ) .", "median os in the temsirolimus and sorafenib arms was @ and @ months , respectively .", "safety profiles of both agents were consistent with previous studies .", "in patients with mrcc and progression on sunitinib , second-line temsirolimus did not demonstrate a pfs advantage compared with sorafenib .", "the longer os observed with sorafenib suggests sequenced vegfr inhibition may benefit patients with mrcc ." ]
this international phase iii trial ( investigating torisel as second-line therapy -lsb- intorsect -rsb- ) compared the efficacy of temsirolimus ( mammalian target of rapamycin inhibitor ) and sorafenib ( vascular endothelial growth factor receptor -lsb- vegfr -rsb- tyrosine kinase inhibitor ) as second-line therapy in patients with metastatic renal cell carcinoma ( mrcc ) after disease progression on sunitinib . in total , @ patients were randomly assigned @:@ to receive intravenous temsirolimus @ mg once weekly ( n = @ ) or oral sorafenib @ mg twice per day ( n = @ ) , with stratification according to duration of prior sunitinib therapy ( or > @ days ) , prognostic risk , histology ( clear cell or non-clear cell ) , and nephrectomy status . the primary end point was progression-free survival ( pfs ) by independent review committee assessment . safety , objective response rate ( orr ) , and overall survival ( os ) were secondary end points . primary analysis revealed no significant difference between treatment arms for pfs ( stratified hazard ratio -lsb- hr -rsb- , @ ; @ % ci , @ to @ ; two-sided p = @ ) or orr . median pfs in the temsirolimus and sorafenib arms were @ and @ months , respectively . there was a significant os difference in favor of sorafenib ( stratified hr , @ ; @ % ci , @ to @ ; two-sided p = @ ) . median os in the temsirolimus and sorafenib arms was @ and @ months , respectively . safety profiles of both agents were consistent with previous studies . in patients with mrcc and progression on sunitinib , second-line temsirolimus did not demonstrate a pfs advantage compared with sorafenib . the longer os observed with sorafenib suggests sequenced vegfr inhibition may benefit patients with mrcc .
24,297,950
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "parathyroidectomy in patients with hyperparathyroidism can produce subsequent increases in bone mineral density ( bmd ) .", "ronacaleret , a selective calcium-sensing receptor antagonist that stimulates endogenous parathyroid hormone release , induced mild hyperparathyroidism .", "the aim of this study is to evaluate whether bmd changes after cessation of ronacaleret treatment .", "observational , off-treatment , extension of a randomized , placebo-controlled , dose-ranging phase ii trial .", "fifteen academic centers in seven countries .", "postmenopausal women with low bmd ; @ out of @ women in the parent study were enrolled in the extension study .", "subjects were treated with ronacaleret @mg ( n = @ ) , @mg ( n = @ ) , @mg ( n = @ ) , or @mg ( n = @ ) once daily , alendronate @mg ( n = @ ) once weekly , or matching placebo ( n = @ ) for @-@months ; bmd was measured after discontinuation of ronacaleret or alendronate treatment .", "mean percent change in lumbar spine areal bmd by dual-energy x-ray absorptiometry at @-@months after discontinuing ronacaleret or alendronate compared with the @ - to @-month bmd measurement of the parent study .", "at the lumbar spine , all doses of ronacaleret resulted in gains in bmd while on treatment .", "these increases in bmd were maintained or increased after discontinuation of ronacaleret .", "all doses of ronacaleret caused bone loss at the total hip while on active treatment .", "however , there was an attenuation of this loss in the off-treatment extension study .", "the gain in bmd at the lumbar spine was maintained post-treatment and the loss of bmd at the total hip was attenuated .", "we hypothesize that there may have been some bone remineralization after cessation of ronacaleret ." ]
parathyroidectomy in patients with hyperparathyroidism can produce subsequent increases in bone mineral density ( bmd ) . ronacaleret , a selective calcium-sensing receptor antagonist that stimulates endogenous parathyroid hormone release , induced mild hyperparathyroidism . the aim of this study is to evaluate whether bmd changes after cessation of ronacaleret treatment . observational , off-treatment , extension of a randomized , placebo-controlled , dose-ranging phase ii trial . fifteen academic centers in seven countries . postmenopausal women with low bmd ; @ out of @ women in the parent study were enrolled in the extension study . subjects were treated with ronacaleret @mg ( n = @ ) , @mg ( n = @ ) , @mg ( n = @ ) , or @mg ( n = @ ) once daily , alendronate @mg ( n = @ ) once weekly , or matching placebo ( n = @ ) for @-@months ; bmd was measured after discontinuation of ronacaleret or alendronate treatment . mean percent change in lumbar spine areal bmd by dual-energy x-ray absorptiometry at @-@months after discontinuing ronacaleret or alendronate compared with the @ - to @-month bmd measurement of the parent study . at the lumbar spine , all doses of ronacaleret resulted in gains in bmd while on treatment . these increases in bmd were maintained or increased after discontinuation of ronacaleret . all doses of ronacaleret caused bone loss at the total hip while on active treatment . however , there was an attenuation of this loss in the off-treatment extension study . the gain in bmd at the lumbar spine was maintained post-treatment and the loss of bmd at the total hip was attenuated . we hypothesize that there may have been some bone remineralization after cessation of ronacaleret .
24,794,093
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to study the influence of aerobic exercise training on brain-derived neurotrophic factor ( bdnf ) , insulin resistance , and lipid profile in middle-aged men diagnosed with metabolic syndrome ( mets ) .", "this is an experimental repeated measure study .", "subjects participated in aerobic training programs ( @ sessions of @-@ minutes per session ) in guilan university gymnasium and court .", "a total of @ middle-aged men ( @-@ years old ) diagnosed with mets participated .", "we randomly divided @ middle-aged men with mets into exercise and control groups .", "the exercise group followed an aerobic training program ( @ sessions , @/wk ) at @ % to @ % of v -lsb- combining dot above -rsb- o@ peak ( @-@ minutes per session ) and @ weeks of detraining .", "blood samples were collected at baseline , end of the training , and detraining .", "high bdnf level in patients with mets and its reduction after chronic aerobic exercise .", "aerobic training significantly decreased all the metabolic risk factors , including overall mets z score , insulin resistance , and lipid profile ( p < @ ) .", "after the detraining period , plasma triglyceride , high-density lipoprotein , and also overall mets z score remained unchanged ( p < @ ) ; however , serum bdnf , which was decreased by aerobic training ( p = @ ) , restored to the baseline at the end of the detraining ( p = @ ) .", "improved metabolic risk factors along with decreased serum bdnf in response to aerobic training and the opposite direction during the detraining emphasize the importance of physical activity in the treatment of mets and prevention of related diseases ." ]
to study the influence of aerobic exercise training on brain-derived neurotrophic factor ( bdnf ) , insulin resistance , and lipid profile in middle-aged men diagnosed with metabolic syndrome ( mets ) . this is an experimental repeated measure study . subjects participated in aerobic training programs ( @ sessions of @-@ minutes per session ) in guilan university gymnasium and court . a total of @ middle-aged men ( @-@ years old ) diagnosed with mets participated . we randomly divided @ middle-aged men with mets into exercise and control groups . the exercise group followed an aerobic training program ( @ sessions , @/wk ) at @ % to @ % of v -lsb- combining dot above -rsb- o@ peak ( @-@ minutes per session ) and @ weeks of detraining . blood samples were collected at baseline , end of the training , and detraining . high bdnf level in patients with mets and its reduction after chronic aerobic exercise . aerobic training significantly decreased all the metabolic risk factors , including overall mets z score , insulin resistance , and lipid profile ( p < @ ) . after the detraining period , plasma triglyceride , high-density lipoprotein , and also overall mets z score remained unchanged ( p < @ ) ; however , serum bdnf , which was decreased by aerobic training ( p = @ ) , restored to the baseline at the end of the detraining ( p = @ ) . improved metabolic risk factors along with decreased serum bdnf in response to aerobic training and the opposite direction during the detraining emphasize the importance of physical activity in the treatment of mets and prevention of related diseases .
24,662,570
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the aims of this study were to compare strut tissue coverage at six-month follow-up after nobori biolimus-eluting stent ( n-bes ) versus sirolimus-eluting stent ( ses ) implantation .", "a total of @ patients with a single stenotic lesion requiring revascularisation were randomly assigned to either n-bes ( n = @ ) or ses ( n = @ ) .", "baseline optical coherence tomography ( oct ) was performed post stent implantation , and follow-up oct was scheduled at six months .", "post-intervention and follow-up oct analyses were available in @ ( @ % ) and @ ( @ % ) patients , respectively .", "the primary endpoint was the percentage of uncovered struts at follow-up oct in all cross-sections with analysis of @ mm longitudinal intervals .", "in addition , an oct contour plot analysis was constructed to investigate the distribution patterns of uncovered struts .", "the percentage of uncovered struts of n-bes was significantly lower versus ses ( @ % versus @ % , respectively , p = @ ) .", "n-bes showed a greater nih thickness than ses ( median -lsb- interquartile range -rsb- @ m -lsb- @-@ @ -rsb- versus @ m -lsb- @-@ @ -rsb- , p = @ ) .", "contour plot analyses showed a lower incidence of a diffuse distribution pattern of uncovered struts ( @ % versus @ % , respectively , p = @ ) .", "this randomised oct study showed that n-bes had a significantly lower percentage of uncovered struts , and less common diffuse distribution pattern of uncovered struts versus ses ." ]
the aims of this study were to compare strut tissue coverage at six-month follow-up after nobori biolimus-eluting stent ( n-bes ) versus sirolimus-eluting stent ( ses ) implantation . a total of @ patients with a single stenotic lesion requiring revascularisation were randomly assigned to either n-bes ( n = @ ) or ses ( n = @ ) . baseline optical coherence tomography ( oct ) was performed post stent implantation , and follow-up oct was scheduled at six months . post-intervention and follow-up oct analyses were available in @ ( @ % ) and @ ( @ % ) patients , respectively . the primary endpoint was the percentage of uncovered struts at follow-up oct in all cross-sections with analysis of @ mm longitudinal intervals . in addition , an oct contour plot analysis was constructed to investigate the distribution patterns of uncovered struts . the percentage of uncovered struts of n-bes was significantly lower versus ses ( @ % versus @ % , respectively , p = @ ) . n-bes showed a greater nih thickness than ses ( median -lsb- interquartile range -rsb- @ m -lsb- @-@ @ -rsb- versus @ m -lsb- @-@ @ -rsb- , p = @ ) . contour plot analyses showed a lower incidence of a diffuse distribution pattern of uncovered struts ( @ % versus @ % , respectively , p = @ ) . this randomised oct study showed that n-bes had a significantly lower percentage of uncovered struts , and less common diffuse distribution pattern of uncovered struts versus ses .
24,531,309
[ "OBJECTIVE", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to explore the necessity of interrupting nerve fibers of bypass thoracic sympathetic chain during edoscopic sympathicotomy ( ets ) for palmar hyperhidrosis .", "randomized controlled trial was performed for @ patients of severe palmar hyperhidrosis from january @ to june @ .", "they were randomly divided into @ groups of r@ thoracic sympathctomy ( r@ ) and r@ thoracic sympathicotomy plus bypass fiber resection at the same level ( r@ + ) ( n = @ each ) .", "clinical observations were recorded during a follow-up period of @ years .", "the curative rates of palmar and axillary hyperhidrosis were @ % for two groups .", "no statistically significant inter-group difference existed in left hand temperature increase after transecting thoracic sympathetic nerve ( @ @ c vs @ @ c ) , right hand increase ( @ @ c vs @ @ c ) , incidence of compensatory hyperhidrosis ( @ % vs @ % ) , recurrence rate ( @ % vs @ % ) and postoperative satisfaction rate ( @ % vs @ % ) .", "but pain scores of r@ group was significantly lower than those of r@ + group ( @ @ vs @ @ , p < @ ) .", "simple transaction of thoracic sympathetic chain during ets is sufficient in the treatment of palmar hyperhidrosis .", "and it is unnecessary to transect bypass fibers ." ]
to explore the necessity of interrupting nerve fibers of bypass thoracic sympathetic chain during edoscopic sympathicotomy ( ets ) for palmar hyperhidrosis . randomized controlled trial was performed for @ patients of severe palmar hyperhidrosis from january @ to june @ . they were randomly divided into @ groups of r@ thoracic sympathctomy ( r@ ) and r@ thoracic sympathicotomy plus bypass fiber resection at the same level ( r@ + ) ( n = @ each ) . clinical observations were recorded during a follow-up period of @ years . the curative rates of palmar and axillary hyperhidrosis were @ % for two groups . no statistically significant inter-group difference existed in left hand temperature increase after transecting thoracic sympathetic nerve ( @ @ c vs @ @ c ) , right hand increase ( @ @ c vs @ @ c ) , incidence of compensatory hyperhidrosis ( @ % vs @ % ) , recurrence rate ( @ % vs @ % ) and postoperative satisfaction rate ( @ % vs @ % ) . but pain scores of r@ group was significantly lower than those of r@ + group ( @ @ vs @ @ , p < @ ) . simple transaction of thoracic sympathetic chain during ets is sufficient in the treatment of palmar hyperhidrosis . and it is unnecessary to transect bypass fibers .
25,623,098
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "most blood donors stop donating blood at the beginning of their donor career .", "this intervention study aims to increase first-time return behaviour of newly registered donors using implementation intentions and explicit commitment techniques .", "newly registered donors ( n = @ ) received an extra information sheet during their medical check-up wherein implementation intentions and explicit commitment techniques were tested .", "donors were randomly assigned to either the control condition , information sheet only condition , information sheet with implementation intentions condition , information sheet with explicit commitment condition , or information sheet with both implementation intentions and explicit commitment condition .", "logistic regression analyses examined actual first-time return behaviour after an appeal to donate blood .", "donors in the information sheet with both implementation intentions and explicit commitment condition had an @ % higher return rate than donors in the control condition .", "logistic regression analyses revealed that the information sheet with both implementation intentions and explicit commitment condition significantly increased the odds on return behaviour compared with the control condition ( or = @ , @ % ci = @-@ @ ) .", "this study successfully increased actual first-time return behaviour of newly registered donors by using both implementation intentions and explicit commitment techniques ." ]
most blood donors stop donating blood at the beginning of their donor career . this intervention study aims to increase first-time return behaviour of newly registered donors using implementation intentions and explicit commitment techniques . newly registered donors ( n = @ ) received an extra information sheet during their medical check-up wherein implementation intentions and explicit commitment techniques were tested . donors were randomly assigned to either the control condition , information sheet only condition , information sheet with implementation intentions condition , information sheet with explicit commitment condition , or information sheet with both implementation intentions and explicit commitment condition . logistic regression analyses examined actual first-time return behaviour after an appeal to donate blood . donors in the information sheet with both implementation intentions and explicit commitment condition had an @ % higher return rate than donors in the control condition . logistic regression analyses revealed that the information sheet with both implementation intentions and explicit commitment condition significantly increased the odds on return behaviour compared with the control condition ( or = @ , @ % ci = @-@ @ ) . this study successfully increased actual first-time return behaviour of newly registered donors by using both implementation intentions and explicit commitment techniques .
25,169,679
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the prognoses of symptomatic and asymptomatic intracranial atherosclerotic stenosis ( icas ) differ .", "understanding the underlying pathomechanisms and predictors of progression or regression may help to clarify the differences .", "we herein attempted to compare the course and predictors of symptomatic icas to those of coexisting asymptomatic icas .", "this was a post-hoc analysis of the ` trials of cilostazol in symptomatic intracranial arterial stenosis-@ ( toss-@ ) ' study , which recruited patients with acute symptomatic icas receiving intensive medical treatment .", "changes in the status of icas were classified as being indicative of regression , progression or no changes .", "univariate and multivariate ordinal regression analyses were performed to identify predictors of symptomatic and asymptomatic icas based on clinical , laboratory and radiologic data .", "of the @ patients , symptomatic icas demonstrated regression in @ ( @ % ) cases and progression in @ ( @ % ) cases .", "among these patients , @ ( @ % ) had asymptomatic icas , which regressed in @ ( @ % ) cases and progressed in @ ( @ % ) cases .", "severe baseline stenosis , a high high-density lipoprotein ( hdl ) cholesterol level and the use of cilostazol were found to be independently associated with a favorable course of symptomatic icas ( p@ @ , p = @ and p = @ , respectively ) .", "regarding asymptomatic icas , severe stenosis , the use of angiotensin receptor antagonists and a low fasting glucose level were associated with a favorable course ( p@ @ , p = @ and p = @ , respectively ) .", "changes in atherosclerosis are more dynamic in patients with symptomatic icas , and the predictors of symptomatic and asymptomatic icas differ .", "in this study , changes in the status of symptomatic icas were associated with the level of hdl cholesterol , which is known to affect the regression of atherosclerosis and vascular remodeling ." ]
the prognoses of symptomatic and asymptomatic intracranial atherosclerotic stenosis ( icas ) differ . understanding the underlying pathomechanisms and predictors of progression or regression may help to clarify the differences . we herein attempted to compare the course and predictors of symptomatic icas to those of coexisting asymptomatic icas . this was a post-hoc analysis of the ` trials of cilostazol in symptomatic intracranial arterial stenosis-@ ( toss-@ ) ' study , which recruited patients with acute symptomatic icas receiving intensive medical treatment . changes in the status of icas were classified as being indicative of regression , progression or no changes . univariate and multivariate ordinal regression analyses were performed to identify predictors of symptomatic and asymptomatic icas based on clinical , laboratory and radiologic data . of the @ patients , symptomatic icas demonstrated regression in @ ( @ % ) cases and progression in @ ( @ % ) cases . among these patients , @ ( @ % ) had asymptomatic icas , which regressed in @ ( @ % ) cases and progressed in @ ( @ % ) cases . severe baseline stenosis , a high high-density lipoprotein ( hdl ) cholesterol level and the use of cilostazol were found to be independently associated with a favorable course of symptomatic icas ( p@ @ , p = @ and p = @ , respectively ) . regarding asymptomatic icas , severe stenosis , the use of angiotensin receptor antagonists and a low fasting glucose level were associated with a favorable course ( p@ @ , p = @ and p = @ , respectively ) . changes in atherosclerosis are more dynamic in patients with symptomatic icas , and the predictors of symptomatic and asymptomatic icas differ . in this study , changes in the status of symptomatic icas were associated with the level of hdl cholesterol , which is known to affect the regression of atherosclerosis and vascular remodeling .
24,573,015
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "selective neck dissection ( snd ) in clinical n@ ( cn@ ) cases of oral squamous cell carcinoma ( scc ) has been performed by surgeons using a retroauricular or modified facelift approach with robotic or endoscopic assistance .", "however , these procedures provide cosmetic satisfaction at the cost of possible maximal invasiveness .", "in this prospective study , we introduced and evaluated the feasibility as well as surgical invasiveness and cosmetic outcome of endoscopically-assisted snd via a small submandibular approach .", "forty-four patients with ct@-@n@ oral scc ( oscc ) were randomly divided into two groups of endoscopically-assisted snd and conventional snd .", "perioperative and postoperative outcomes of patients were evaluated , including the length of the incision , operating time for neck dissection , estimated blood loss during the operation , amount and duration of drainage , total hospitalization period , total number of lymph nodes retrieved , satisfaction scores based on the cosmetic results , perioperative local complications , shoulder syndrome , and follow-up information .", "the mean operation time in the endoscopically-assisted group ( @ min ) was longer than that in the conventional group ( @ min ) .", "however , the mean length of the incision was @ cm in the endoscopically-assisted snd group , and the amount and duration of drainage , total hospital stay , postoperative shoulder pain score , and cosmetic outcomes were superior in the endoscopically-assisted snd group .", "additionally , the retrieved lymph nodes and complications were comparable .", "endoscopically-assisted snd via a small submandibular approach had a longer operation time than the conventional approach .", "however , endoscopically-assisted snd was feasible and reliable while providing minimal invasiveness and satisfactory appearance ." ]
selective neck dissection ( snd ) in clinical n@ ( cn@ ) cases of oral squamous cell carcinoma ( scc ) has been performed by surgeons using a retroauricular or modified facelift approach with robotic or endoscopic assistance . however , these procedures provide cosmetic satisfaction at the cost of possible maximal invasiveness . in this prospective study , we introduced and evaluated the feasibility as well as surgical invasiveness and cosmetic outcome of endoscopically-assisted snd via a small submandibular approach . forty-four patients with ct@-@n@ oral scc ( oscc ) were randomly divided into two groups of endoscopically-assisted snd and conventional snd . perioperative and postoperative outcomes of patients were evaluated , including the length of the incision , operating time for neck dissection , estimated blood loss during the operation , amount and duration of drainage , total hospitalization period , total number of lymph nodes retrieved , satisfaction scores based on the cosmetic results , perioperative local complications , shoulder syndrome , and follow-up information . the mean operation time in the endoscopically-assisted group ( @ min ) was longer than that in the conventional group ( @ min ) . however , the mean length of the incision was @ cm in the endoscopically-assisted snd group , and the amount and duration of drainage , total hospital stay , postoperative shoulder pain score , and cosmetic outcomes were superior in the endoscopically-assisted snd group . additionally , the retrieved lymph nodes and complications were comparable . endoscopically-assisted snd via a small submandibular approach had a longer operation time than the conventional approach . however , endoscopically-assisted snd was feasible and reliable while providing minimal invasiveness and satisfactory appearance .
24,912,615
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the radiation therapy oncology group @-@ clinical trial demonstrated the superiority of standard @-fluorouracil/mitomycin-c over @-fluorouracil/cisplatin in combination with radiation in the treatment of anal squamous cell cancer .", "tumor size ( > @ cm ) and lymph node metastases are associated with disease progression .", "there may be key molecular differences ( eg , dna methylation changes ) in tumors at high risk for progression .", "the objectives of this study were to determine whether there are differences in dna methylation at individual cpg sites and within genes among locally advanced anal cancers , with large tumor size and/or nodal involvement , compared with those that are less advanced .", "this was a case-case study among @ patients defined as high risk ( tumor size > @ cm and/or nodal involvement ; n = @ ) or low risk ( @ cm , node negative ; n = @ ) within the mitomycin-c arm of the radiation therapy oncology group @-@ trial .", "dna methylation was measured using the illumina humanmethylation@ array .", "the study was conducted in a tertiary care cancer center in collaboration with a national clinical trials cooperative group .", "the patients consisted of @ women and @ men with a median age of @ years ( range , @-@ years ) .", "dna methylation differences at individual cpg sites and within genes between low - and high-risk patients were compared using the mann-whitney test ( p < @ ) .", "a total of @ cpg loci were differentially methylated ( @ increased and @ decreased ) in high - versus low-risk cases .", "genes harboring differentially methylated cpg sites included known tumor suppressor genes and novel targets .", "this study only included patients in the mitomycin-c arm with tumor tissue ; however , this sample was representative of the trial .", "this is the first study to apply genome-wide methylation analysis to anal cancer .", "biologically relevant differences in methylated targets were found to discriminate locally advanced from early anal cancer .", "epigenetic events likely play a significant role in the progression of anal cancer and may serve as potential biomarkers ." ]
the radiation therapy oncology group @-@ clinical trial demonstrated the superiority of standard @-fluorouracil/mitomycin-c over @-fluorouracil/cisplatin in combination with radiation in the treatment of anal squamous cell cancer . tumor size ( > @ cm ) and lymph node metastases are associated with disease progression . there may be key molecular differences ( eg , dna methylation changes ) in tumors at high risk for progression . the objectives of this study were to determine whether there are differences in dna methylation at individual cpg sites and within genes among locally advanced anal cancers , with large tumor size and/or nodal involvement , compared with those that are less advanced . this was a case-case study among @ patients defined as high risk ( tumor size > @ cm and/or nodal involvement ; n = @ ) or low risk ( @ cm , node negative ; n = @ ) within the mitomycin-c arm of the radiation therapy oncology group @-@ trial . dna methylation was measured using the illumina humanmethylation@ array . the study was conducted in a tertiary care cancer center in collaboration with a national clinical trials cooperative group . the patients consisted of @ women and @ men with a median age of @ years ( range , @-@ years ) . dna methylation differences at individual cpg sites and within genes between low - and high-risk patients were compared using the mann-whitney test ( p < @ ) . a total of @ cpg loci were differentially methylated ( @ increased and @ decreased ) in high - versus low-risk cases . genes harboring differentially methylated cpg sites included known tumor suppressor genes and novel targets . this study only included patients in the mitomycin-c arm with tumor tissue ; however , this sample was representative of the trial . this is the first study to apply genome-wide methylation analysis to anal cancer . biologically relevant differences in methylated targets were found to discriminate locally advanced from early anal cancer . epigenetic events likely play a significant role in the progression of anal cancer and may serve as potential biomarkers .
25,003,289
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "orthotopic liver transplantation ( olt ) has become the therapeutic option of choice for end-stage liver disease .", "the aim of this study was to investigate the changes of splenic morphology , signal-to-noise ratio ( snr ) , contrast-to-noise ratio ( cnr ) , apparent diffusion coefficient ( adc ) values and explore their value in evaluating the therapeutic effects of orthotopic liver transplantation ( olt ) on portal hypertension at @ tesla mri .", "twenty patients with portal hypertension undergoing olt were included in this study .", "conventional mri and diffusion-weighted image ( dwi ) ( b value = @ s/mm ( @ ) ) sequences were applied on each patient before and after olt , and these patients were referred to as the preoperative and postoperative groups .", "twenty healthy individuals were selected as the normal group .", "after image acquisition , the splenic width ( w ) , thickness ( t ) , length ( l ) , the diameter of the portal vein ( pd ) and splenic vein ( sd ) were measured and the splenic volume ( v ) was calculated .", "the snr and cnr were measured on t@wi .", "the adc maps were calculated using the b@ in dwis and the adc values were measured .", "compared with the preoperative group , the splenic v , pd and sd decreased significantly in the postoperative group ( p < @ ) .", "all splenic morphological values were significantly different between preoperative and normal groups ( p < @ ) .", "the splenic l and v were significantly different ( p < @ ) between postoperative and normal groups .", "the snr and cnr values were @ @ and @ @ , @ @ and @ @ , @ @ and @ @ in the preoperative , postoperative and normal groups , respectively .", "both snr and cnr decreased after olt , but they was still higher than the normal values .", "the snr was significantly different between any two groups ( p < @ ) .", "the cnr was significantly different ( p < @ ) between the preoperative and postoperative groups , preoperative and normal groups .", "the splenic adc values were ( @ @ ) @ ( -@ ) mm ( @ ) / s , ( @ @ ) @ ( -@ ) mm ( @ ) / s and ( @ @ ) @ ( -@ ) mm ( @ ) / s in the preoperative , postoperative and normal groups , respectively .", "the difference of adc values were significant ( p < @ ) between the preoperative and postoperative groups , and the preoperative and normal groups .", "olt is an effective method of treatment for portal hypertension .", "in addition to dramatically decreasing the splenic v , it can also decrease the splenic snr , cnr and adc values in patients with portal hypertension .", "the changes of splenic snr , cnr and adc after olt may be helpful in providing noninvasive supplementary information in assessing the therapeutic effect of olt on portal hypertension ." ]
orthotopic liver transplantation ( olt ) has become the therapeutic option of choice for end-stage liver disease . the aim of this study was to investigate the changes of splenic morphology , signal-to-noise ratio ( snr ) , contrast-to-noise ratio ( cnr ) , apparent diffusion coefficient ( adc ) values and explore their value in evaluating the therapeutic effects of orthotopic liver transplantation ( olt ) on portal hypertension at @ tesla mri . twenty patients with portal hypertension undergoing olt were included in this study . conventional mri and diffusion-weighted image ( dwi ) ( b value = @ s/mm ( @ ) ) sequences were applied on each patient before and after olt , and these patients were referred to as the preoperative and postoperative groups . twenty healthy individuals were selected as the normal group . after image acquisition , the splenic width ( w ) , thickness ( t ) , length ( l ) , the diameter of the portal vein ( pd ) and splenic vein ( sd ) were measured and the splenic volume ( v ) was calculated . the snr and cnr were measured on t@wi . the adc maps were calculated using the b@ in dwis and the adc values were measured . compared with the preoperative group , the splenic v , pd and sd decreased significantly in the postoperative group ( p < @ ) . all splenic morphological values were significantly different between preoperative and normal groups ( p < @ ) . the splenic l and v were significantly different ( p < @ ) between postoperative and normal groups . the snr and cnr values were @ @ and @ @ , @ @ and @ @ , @ @ and @ @ in the preoperative , postoperative and normal groups , respectively . both snr and cnr decreased after olt , but they was still higher than the normal values . the snr was significantly different between any two groups ( p < @ ) . the cnr was significantly different ( p < @ ) between the preoperative and postoperative groups , preoperative and normal groups . the splenic adc values were ( @ @ ) @ ( -@ ) mm ( @ ) / s , ( @ @ ) @ ( -@ ) mm ( @ ) / s and ( @ @ ) @ ( -@ ) mm ( @ ) / s in the preoperative , postoperative and normal groups , respectively . the difference of adc values were significant ( p < @ ) between the preoperative and postoperative groups , and the preoperative and normal groups . olt is an effective method of treatment for portal hypertension . in addition to dramatically decreasing the splenic v , it can also decrease the splenic snr , cnr and adc values in patients with portal hypertension . the changes of splenic snr , cnr and adc after olt may be helpful in providing noninvasive supplementary information in assessing the therapeutic effect of olt on portal hypertension .
25,269,900
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "modic changes ( mc ) are associated with low back pain ( lbp ) , but effective treatments are lacking .", "the aim of this randomized , placebo-controlled , double-blinded trial was to evaluate the efficacy of zoledronic acid ( za ) for chronic lbp among patients with mc in magnetic resonance imaging ( mri ) .", "inclusion criteria were lbp lasting @ months , with an intensity of @ on a @-cm vas or an oswestry disability index ( odi ) of @ % , and mc in mri .", "patients were randomized into single intravenous infusion of za @ mg ( n = @ ) , or placebo ( n = @ ) groups .", "the primary outcome was lbp intensity , secondary outcomes leg pain intensity , odi , health-related quality of life ( rand-@ ) , lumbar flexibility , sick leaves and use of pain medication .", "the treatment differences at one month and one year were analysed using ancova with adjustment for the baseline score .", "the mean difference ( md ) between the groups in the primary outcome , intensity of lbp , was @ ( @ % confidence intervals ( ci ) @ to @ ) in favour of za at one month .", "we observed no significant between-group difference in the intensity of lbp at one year ( md @ ; @ % ci -@ to @ ) or in secondary outcomes at any time point except that @ % of patients in the za group used non-steroidal anti-inflammatory drugs at one year compared to @ % in the placebo group ( p = @ ) .", "acute phase reactions ( fever , flu-like symptoms , arthralgia ) emerged in @ % of the patients in the za group , compared to @ % in the placebo group .", "za was effective in reducing the intensity of lbp in the short term and in reducing the use of nsaids within the time span of one year among patients with chronic lbp and mc confirmed in mri .", "although the results seem encouraging , larger studies are required to analyse the effectiveness and safety of za for patients with mc .", "clinicaltrial.gov identifier nct@ ." ]
modic changes ( mc ) are associated with low back pain ( lbp ) , but effective treatments are lacking . the aim of this randomized , placebo-controlled , double-blinded trial was to evaluate the efficacy of zoledronic acid ( za ) for chronic lbp among patients with mc in magnetic resonance imaging ( mri ) . inclusion criteria were lbp lasting @ months , with an intensity of @ on a @-cm vas or an oswestry disability index ( odi ) of @ % , and mc in mri . patients were randomized into single intravenous infusion of za @ mg ( n = @ ) , or placebo ( n = @ ) groups . the primary outcome was lbp intensity , secondary outcomes leg pain intensity , odi , health-related quality of life ( rand-@ ) , lumbar flexibility , sick leaves and use of pain medication . the treatment differences at one month and one year were analysed using ancova with adjustment for the baseline score . the mean difference ( md ) between the groups in the primary outcome , intensity of lbp , was @ ( @ % confidence intervals ( ci ) @ to @ ) in favour of za at one month . we observed no significant between-group difference in the intensity of lbp at one year ( md @ ; @ % ci -@ to @ ) or in secondary outcomes at any time point except that @ % of patients in the za group used non-steroidal anti-inflammatory drugs at one year compared to @ % in the placebo group ( p = @ ) . acute phase reactions ( fever , flu-like symptoms , arthralgia ) emerged in @ % of the patients in the za group , compared to @ % in the placebo group . za was effective in reducing the intensity of lbp in the short term and in reducing the use of nsaids within the time span of one year among patients with chronic lbp and mc confirmed in mri . although the results seem encouraging , larger studies are required to analyse the effectiveness and safety of za for patients with mc . clinicaltrial.gov identifier nct@ .
24,588,905
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "postoperative ileus ( poi ) is a common complication following colorectal surgery that delays recovery and increases length of hospital stay .", "gum chewing may reduce poi and therefore enhance recovery after surgery .", "the aim of the study was to evaluate the effect of gum chewing on poi , length of hospital stay and inflammatory parameters .", "patients undergoing elective colorectal surgery in one of two centres were randomized to either chewing gum or a dermal patch ( control ) .", "chewing gum was started before surgery and stopped when oral intake was resumed .", "primary endpoints were poi and length of stay .", "secondary endpoints were systemic and local inflammation , and surgical complications .", "gastric emptying was measured by ultrasonography .", "soluble tumour necrosis factor receptor @ ( tnfrsf@a ) and interleukin ( il ) @ levels were measured by enzyme-linked immunosorbent assay .", "between may @ and september @ , @ patients were randomized to chewing gum ( @ ) or dermal patch ( control group ; @ ) .", "mean ( s.d. ) length of hospital stay was shorter in the chewing gum group than in controls , but this difference was not significant : @ ( @ ) versus @ ( @ ) days respectively .", "some @ ( @ per cent ) of @ analysed patients allocated to chewing gum developed poi compared with @ ( @ per cent ) of @ patients in the control group ( p = @ ) .", "more patients in the chewing gum group first defaecated within @ days of surgery ( @ versus @ per cent ; p = @ ) and passed first flatus within @h ( @ versus @ per cent ; p = @ ) .", "the decrease in antral area measured by ultrasonography following a standard meal was significantly greater among patients who chewed gum : median @ ( range -@ to @ ) per cent compared with @ ( range -@ to @ ) per cent in controls ( p = @ ) .", "levels of il-@ ( @ versus @pg/ml ; p = @ ) and tnfrsf@a ( @ versus @ng/ml ; p = @ ) were lower among patients in the chewing gum group .", "fewer patients in this group developed a grade iiib complication ( @ of @ versus @ of @ ; p = @ ) .", "gum chewing is a safe and simple treatment to reduce poi , and is associated with a reduction in systemic inflammatory markers and complications .", "ntr@ ( http://www.trialregister.nl ) ." ]
postoperative ileus ( poi ) is a common complication following colorectal surgery that delays recovery and increases length of hospital stay . gum chewing may reduce poi and therefore enhance recovery after surgery . the aim of the study was to evaluate the effect of gum chewing on poi , length of hospital stay and inflammatory parameters . patients undergoing elective colorectal surgery in one of two centres were randomized to either chewing gum or a dermal patch ( control ) . chewing gum was started before surgery and stopped when oral intake was resumed . primary endpoints were poi and length of stay . secondary endpoints were systemic and local inflammation , and surgical complications . gastric emptying was measured by ultrasonography . soluble tumour necrosis factor receptor @ ( tnfrsf@a ) and interleukin ( il ) @ levels were measured by enzyme-linked immunosorbent assay . between may @ and september @ , @ patients were randomized to chewing gum ( @ ) or dermal patch ( control group ; @ ) . mean ( s.d. ) length of hospital stay was shorter in the chewing gum group than in controls , but this difference was not significant : @ ( @ ) versus @ ( @ ) days respectively . some @ ( @ per cent ) of @ analysed patients allocated to chewing gum developed poi compared with @ ( @ per cent ) of @ patients in the control group ( p = @ ) . more patients in the chewing gum group first defaecated within @ days of surgery ( @ versus @ per cent ; p = @ ) and passed first flatus within @h ( @ versus @ per cent ; p = @ ) . the decrease in antral area measured by ultrasonography following a standard meal was significantly greater among patients who chewed gum : median @ ( range -@ to @ ) per cent compared with @ ( range -@ to @ ) per cent in controls ( p = @ ) . levels of il-@ ( @ versus @pg/ml ; p = @ ) and tnfrsf@a ( @ versus @ng/ml ; p = @ ) were lower among patients in the chewing gum group . fewer patients in this group developed a grade iiib complication ( @ of @ versus @ of @ ; p = @ ) . gum chewing is a safe and simple treatment to reduce poi , and is associated with a reduction in systemic inflammatory markers and complications . ntr@ ( http://www.trialregister.nl ) .
25,524,125
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]