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[ "a double-blinded randomized clinical trial .", "the anti-inflammatory and neuroprotective effect of omega-@ fatty acids have been shown so far , but still its influence on clinical measures in spinal cord-injured human models were not known .", "we tried to investigate changes in disability and dependency scores in chronic traumatic spinal cord-injured patients after @ months of -@ fatty-acid consumption .", "main inclusion criteria were : traumatic spinal cord injury ( sci ) and post injury duration longer than @ year .", "disability and dependency was assessed using u.k functional independence measure and functional assessment measure ( fim+fam ) scale .", "mordha capsules ( @mg of docosahexaenoic acid and @mg of eicosapentaenoic acid ) were administered in treatment group , whereas control group received placebo capsules for @ months .", "u.k. fim+fam scale were estimated before intervention and at the end of the trial .", "fifty-four patients in treatment group and @ patients in placebo group completed the trial .", "highest scores were detected in cognitive domain in both groups before and after intervention .", "most dependency was observed in locomotion subscale and secondly in sphincter control .", "scores of none of these components were changed by -@ fatty-acid consumption .", "although omega-@ fatty acids have been shown to have neuroprotective effect in acute phase of sci , it seems that they have no significant influence in chronic inflammatory state of sci .", "the positive effect of -@ fatty acid in chronic neurorecovery process , if exists , is weaker to exert any significant improvement in uk fim+fam scores in spinal cord-injured individuals ." ]
a double-blinded randomized clinical trial . the anti-inflammatory and neuroprotective effect of omega-@ fatty acids have been shown so far , but still its influence on clinical measures in spinal cord-injured human models were not known . we tried to investigate changes in disability and dependency scores in chronic traumatic spinal cord-injured patients after @ months of -@ fatty-acid consumption . main inclusion criteria were : traumatic spinal cord injury ( sci ) and post injury duration longer than @ year . disability and dependency was assessed using u.k functional independence measure and functional assessment measure ( fim+fam ) scale . mordha capsules ( @mg of docosahexaenoic acid and @mg of eicosapentaenoic acid ) were administered in treatment group , whereas control group received placebo capsules for @ months . u.k. fim+fam scale were estimated before intervention and at the end of the trial . fifty-four patients in treatment group and @ patients in placebo group completed the trial . highest scores were detected in cognitive domain in both groups before and after intervention . most dependency was observed in locomotion subscale and secondly in sphincter control . scores of none of these components were changed by -@ fatty-acid consumption . although omega-@ fatty acids have been shown to have neuroprotective effect in acute phase of sci , it seems that they have no significant influence in chronic inflammatory state of sci . the positive effect of -@ fatty acid in chronic neurorecovery process , if exists , is weaker to exert any significant improvement in uk fim+fam scores in spinal cord-injured individuals .
24,637,568
[ "METHODS", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "who guidelines recommend early initiation of antiretroviral therapy ( art ) irrespective of cd@ cell count for all patients with tuberculosis who also have hiv , but evidence supporting this approach is poor quality .", "we assessed the effect of timing of art initiation on tuberculosis treatment outcomes for hiv-positive patients with cd@ counts of @ cells per l or more .", "we did this randomised , placebo-controlled trial between jan @ , @ , and april @ , @ at @ treatment centres in south africa , tanzania , uganda , and zambia .", "we enrolled hiv-positive patients with culture-confirmed tuberculosis who had tolerated @ weeks of tuberculosis short course chemotherapy .", "participants were randomly allocated ( @:@ ) to early art ( starting after @ weeks of tuberculosis treatment ) or delayed art ( placebo , then starting art at the end of @ months of tuberculosis treatment ) .", "randomisation was computer generated , with permuted blocks of size eight , and stratified by cd@ count ( @-@ cells per l vs @ cells per l ) .", "patients and investigators were masked to treatment allocation until completion of @-months ' tuberculosis treatment , after which the study was open label .", "the primary endpoint was a composite of failure of tuberculosis treatment , tuberculosis recurrence , and death within @ months of starting tuberculosis treatment in the modified intention-to-treat population .", "secondary endpoints included mortality .", "the study is registered with controlled-trials .", "com ( isrctn@ ) .", "we screened @,@ patients and enrolled @ : @ assigned early art , @ delayed art .", "the primary endpoint was reached by @ ( @ % ) of @ patients in the early art group versus @ ( @ % ) of @ in the delayed art group ( relative risk -lsb- rr -rsb- @ , @ % ci @-@ ; p = @ ) .", "of patients with a cd@ cell count of @-@ cells per l , @ ( @ % ) of @ patients versus @ ( @ % ) of @ reached the primary endpoint ( rr @ , @ % ci @-@ ; p = @ ) .", "for those with @ cells per l or more , @ ( @ % ) of @ versus @ ( @ % ) of @ reached the primary endpoint ( rr @ , @ % ci @-@ ; p = @ ) .", "mortality did not differ significantly between treatment groups ( rr @ , @ % ci @-@ ; p = @ ) .", "grade @ and @ adverse events occurred in @ ( @ % ) of @ patients assigned early art versus @ ( @ % ) of @ assigned delayed art ( p = @ ) .", "@ ( @ % ) of @ versus @ ( @ % ) of @ had immune reconstitution inflammatory syndrome ( p = @ ) .", "art can be delayed until after completion of @ months of tuberculosis treatment for hiv-positive patients with tuberculosis who have cd@ cell counts greater than @ cells per l.", "who guidelines should be updated accordingly .", "usaid , zambia ministry of health , tanzania commission for science and technology , who-tdr ." ]
who guidelines recommend early initiation of antiretroviral therapy ( art ) irrespective of cd@ cell count for all patients with tuberculosis who also have hiv , but evidence supporting this approach is poor quality . we assessed the effect of timing of art initiation on tuberculosis treatment outcomes for hiv-positive patients with cd@ counts of @ cells per l or more . we did this randomised , placebo-controlled trial between jan @ , @ , and april @ , @ at @ treatment centres in south africa , tanzania , uganda , and zambia . we enrolled hiv-positive patients with culture-confirmed tuberculosis who had tolerated @ weeks of tuberculosis short course chemotherapy . participants were randomly allocated ( @:@ ) to early art ( starting after @ weeks of tuberculosis treatment ) or delayed art ( placebo , then starting art at the end of @ months of tuberculosis treatment ) . randomisation was computer generated , with permuted blocks of size eight , and stratified by cd@ count ( @-@ cells per l vs @ cells per l ) . patients and investigators were masked to treatment allocation until completion of @-months ' tuberculosis treatment , after which the study was open label . the primary endpoint was a composite of failure of tuberculosis treatment , tuberculosis recurrence , and death within @ months of starting tuberculosis treatment in the modified intention-to-treat population . secondary endpoints included mortality . the study is registered with controlled-trials . com ( isrctn@ ) . we screened @,@ patients and enrolled @ : @ assigned early art , @ delayed art . the primary endpoint was reached by @ ( @ % ) of @ patients in the early art group versus @ ( @ % ) of @ in the delayed art group ( relative risk -lsb- rr -rsb- @ , @ % ci @-@ ; p = @ ) . of patients with a cd@ cell count of @-@ cells per l , @ ( @ % ) of @ patients versus @ ( @ % ) of @ reached the primary endpoint ( rr @ , @ % ci @-@ ; p = @ ) . for those with @ cells per l or more , @ ( @ % ) of @ versus @ ( @ % ) of @ reached the primary endpoint ( rr @ , @ % ci @-@ ; p = @ ) . mortality did not differ significantly between treatment groups ( rr @ , @ % ci @-@ ; p = @ ) . grade @ and @ adverse events occurred in @ ( @ % ) of @ patients assigned early art versus @ ( @ % ) of @ assigned delayed art ( p = @ ) . @ ( @ % ) of @ versus @ ( @ % ) of @ had immune reconstitution inflammatory syndrome ( p = @ ) . art can be delayed until after completion of @ months of tuberculosis treatment for hiv-positive patients with tuberculosis who have cd@ cell counts greater than @ cells per l. who guidelines should be updated accordingly . usaid , zambia ministry of health , tanzania commission for science and technology , who-tdr .
24,810,491
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "neurofeedback aims to reduce symptoms of attention-deficit/hyperactivity disorder ( adhd ) , mainly attention problems .", "however , the additional influence of neurofeedback over treatment as usual ( tau ) on neurocognitive functioning for adolescents with adhd remains unclear .", "by using a multicenter parallel randomized controlled trial ( rct ) design , male adolescents with a dsm-iv-tr diagnosis of adhd ( mean age = @ years ; range , @-@ ) were randomized to receive either a combination of tau and neurofeedback ( n = @ ) or tau ( n = @ ) .", "randomization was computer generated and stratified by age group ( ages @ through @ , @ through @ , and @ through @ years ) .", "the neurofeedback intervention consisted of approximately @ sessions over a period of @ weeks of theta/sensorimotor rhythm training on the vertex ( cz ) .", "primary neurocognitive outcomes included performance parameters derived from the d@ test of attention , the digit span backward , the stroop color-word test and the tower of london , all assessed preintervention and postintervention .", "data were collected between december @ and july @ .", "at postintervention , outcomes of attention and/or motor speed were improved , with faster processing times for both intervention conditions and with medium to large effect sizes ( range , p@ = @ -@ ; p values < @ ) .", "in both groups , no improvements for higher executive functions were observed .", "results might partly resemble practice effects .", "although neurocognitive outcomes improved in all adolescents receiving treatment for adhd , no additional value for neurofeedback over tau was observed .", "hence , this study does not provide evidence for using theta/sensorimotor rhythm neurofeedback to enhance neurocognitive performance as additional intervention to tau for adolescents with adhd symptoms .", "trialregister.nl identifier : @ ." ]
neurofeedback aims to reduce symptoms of attention-deficit/hyperactivity disorder ( adhd ) , mainly attention problems . however , the additional influence of neurofeedback over treatment as usual ( tau ) on neurocognitive functioning for adolescents with adhd remains unclear . by using a multicenter parallel randomized controlled trial ( rct ) design , male adolescents with a dsm-iv-tr diagnosis of adhd ( mean age = @ years ; range , @-@ ) were randomized to receive either a combination of tau and neurofeedback ( n = @ ) or tau ( n = @ ) . randomization was computer generated and stratified by age group ( ages @ through @ , @ through @ , and @ through @ years ) . the neurofeedback intervention consisted of approximately @ sessions over a period of @ weeks of theta/sensorimotor rhythm training on the vertex ( cz ) . primary neurocognitive outcomes included performance parameters derived from the d@ test of attention , the digit span backward , the stroop color-word test and the tower of london , all assessed preintervention and postintervention . data were collected between december @ and july @ . at postintervention , outcomes of attention and/or motor speed were improved , with faster processing times for both intervention conditions and with medium to large effect sizes ( range , p@ = @ -@ ; p values < @ ) . in both groups , no improvements for higher executive functions were observed . results might partly resemble practice effects . although neurocognitive outcomes improved in all adolescents receiving treatment for adhd , no additional value for neurofeedback over tau was observed . hence , this study does not provide evidence for using theta/sensorimotor rhythm neurofeedback to enhance neurocognitive performance as additional intervention to tau for adolescents with adhd symptoms . trialregister.nl identifier : @ .
24,922,488
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "high blood pressure is a prognostic factor for acute stroke , but blood pressure variability might also independently predict outcome .", "we assessed the prognostic value of blood pressure variability in participants of interact@ , an open-label randomised controlled trial ( clinicaltrials.gov number nct@ ) .", "interact@ enrolled @ adults with spontaneous intracerebral haemorrhage ( ich ) and high systolic blood pressure ( @-@ mm hg ) without a definite indication or contraindication to early intensive treatment to reduce blood pressure .", "participants were randomly assigned to intensive treatment ( target systolic blood pressure < @ mm hg within @ h using locally available intravenous drugs ) or guideline-recommended treatment ( target systolic blood pressure < @ mm hg ) within @ h of onset of ich .", "the primary outcome was death or major disability at @ days ( modified rankin scale score @ ) and the secondary outcome was an ordinal shift in modified rankin scale scores at @ days , assessed by investigators masked to treatment allocation .", "blood pressure variability was defined according to standard criteria : five measurements were taken in the first @ h ( hyperacute phase ) and @ over days @-@ ( acute phase ) .", "we estimated associations between blood pressure variability and outcomes with logistic and proportional odds regression models .", "the key parameter for blood pressure variability was standard deviation ( sd ) of systolic blood pressure , categorised into quintiles .", "we studied @ ( @ % ) participants in the hyperacute phase and @ ( @ % ) in the acute phase .", "in both treatment cohorts combined , sd of systolic blood pressure had a significant linear association with the primary outcome for both the hyperacute phase ( highest quintile adjusted or @ , @ % ci @-@ ; ptrend = @ ) and the acute phase ( highest quintile adjusted or @ , @ % ci @-@ ; ptrend = @ ) .", "the strongest predictors of outcome were maximum systolic blood pressure in the hyperacute phase and sd of systolic blood pressure in the acute phase .", "associations were similar for the secondary outcome ( for the hyperacute phase , highest quintile adjusted or @ , @ % ci @-@ ; ptrend = @ ; for the acute phase or @ , @ % ci @-@ ; ptrend = @ ) .", "systolic blood pressure variability seems to predict a poor outcome in patients with acute intracerebral haemorrhage .", "the benefits of early treatment to reduce systolic blood pressure to @ mm hg might be enhanced by smooth and sustained control , and particularly by avoiding peaks in systolic blood pressure .", "national health and medical research council of australia ." ]
high blood pressure is a prognostic factor for acute stroke , but blood pressure variability might also independently predict outcome . we assessed the prognostic value of blood pressure variability in participants of interact@ , an open-label randomised controlled trial ( clinicaltrials.gov number nct@ ) . interact@ enrolled @ adults with spontaneous intracerebral haemorrhage ( ich ) and high systolic blood pressure ( @-@ mm hg ) without a definite indication or contraindication to early intensive treatment to reduce blood pressure . participants were randomly assigned to intensive treatment ( target systolic blood pressure < @ mm hg within @ h using locally available intravenous drugs ) or guideline-recommended treatment ( target systolic blood pressure < @ mm hg ) within @ h of onset of ich . the primary outcome was death or major disability at @ days ( modified rankin scale score @ ) and the secondary outcome was an ordinal shift in modified rankin scale scores at @ days , assessed by investigators masked to treatment allocation . blood pressure variability was defined according to standard criteria : five measurements were taken in the first @ h ( hyperacute phase ) and @ over days @-@ ( acute phase ) . we estimated associations between blood pressure variability and outcomes with logistic and proportional odds regression models . the key parameter for blood pressure variability was standard deviation ( sd ) of systolic blood pressure , categorised into quintiles . we studied @ ( @ % ) participants in the hyperacute phase and @ ( @ % ) in the acute phase . in both treatment cohorts combined , sd of systolic blood pressure had a significant linear association with the primary outcome for both the hyperacute phase ( highest quintile adjusted or @ , @ % ci @-@ ; ptrend = @ ) and the acute phase ( highest quintile adjusted or @ , @ % ci @-@ ; ptrend = @ ) . the strongest predictors of outcome were maximum systolic blood pressure in the hyperacute phase and sd of systolic blood pressure in the acute phase . associations were similar for the secondary outcome ( for the hyperacute phase , highest quintile adjusted or @ , @ % ci @-@ ; ptrend = @ ; for the acute phase or @ , @ % ci @-@ ; ptrend = @ ) . systolic blood pressure variability seems to predict a poor outcome in patients with acute intracerebral haemorrhage . the benefits of early treatment to reduce systolic blood pressure to @ mm hg might be enhanced by smooth and sustained control , and particularly by avoiding peaks in systolic blood pressure . national health and medical research council of australia .
24,530,176
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "to investigate the ideal digestive tract reconstruction methods among three different surgical methods after radical gastrectomy of gastric cancer patients .", "a total of @ patients who received elective radical gastrectomy for gastric cancer from february @ to august @ were prospectively enrolled and randomly divided into radical proximal gastrectomy and jejunal interposition group , radical proximal gastrectomy and esophageal with the posterior of residual-stomach group , and radical total gastrectomy and roux-en-y esophagojejunostomy group .", "patients were followed up for @ months .", "symptoms of reflux esophagitis were observed , gastric emptying tests were done , liver and kidney function was also monitored .", "the quality of life was documented before operation , and one and twelve months after operation .", "no significant differences were found among these three groups in the ph value of lower part of esophagus , the blood regular test results and the functional parameters of kidney and liver before and after operation ( all p > @ ) .", "symptoms of reflux esophagitis was reported in @ ( @ % ) patients in the jejunal interposition group , @ ( @ % ) in esophageal with the posterial of residual-stomach group , and @ ( @ % ) in the roux-en-y esophagojejunostomy group ( p = @ ) .", "there was @ ( @ % ) , @ ( @ % ) , and @ ( @ % ) patients presented reflux of barium meal in these three groups , respectively ( p = @ ) .", "there were no statistically significant difference in ph at the distal esophagus ( @ vs. @ vs. @ , p = @ ) .", "the quality of life was significantly improved one year after surgery in terms of general status , physical function , emotional function , fatigue , nausea/vomiting , pain , constipation , and diarrhea ( all p < @ ) , with the jejunal interposition superior than the other two methods .", "three methods of digestive tract reconstruction in radical gastrectomy of gastric cancer patients can improve the health status and the quality of life in gastric cancer patients .", "radical proximal gastrectomy and jejunal interposition is the preferred method ." ]
to investigate the ideal digestive tract reconstruction methods among three different surgical methods after radical gastrectomy of gastric cancer patients . a total of @ patients who received elective radical gastrectomy for gastric cancer from february @ to august @ were prospectively enrolled and randomly divided into radical proximal gastrectomy and jejunal interposition group , radical proximal gastrectomy and esophageal with the posterior of residual-stomach group , and radical total gastrectomy and roux-en-y esophagojejunostomy group . patients were followed up for @ months . symptoms of reflux esophagitis were observed , gastric emptying tests were done , liver and kidney function was also monitored . the quality of life was documented before operation , and one and twelve months after operation . no significant differences were found among these three groups in the ph value of lower part of esophagus , the blood regular test results and the functional parameters of kidney and liver before and after operation ( all p > @ ) . symptoms of reflux esophagitis was reported in @ ( @ % ) patients in the jejunal interposition group , @ ( @ % ) in esophageal with the posterial of residual-stomach group , and @ ( @ % ) in the roux-en-y esophagojejunostomy group ( p = @ ) . there was @ ( @ % ) , @ ( @ % ) , and @ ( @ % ) patients presented reflux of barium meal in these three groups , respectively ( p = @ ) . there were no statistically significant difference in ph at the distal esophagus ( @ vs. @ vs. @ , p = @ ) . the quality of life was significantly improved one year after surgery in terms of general status , physical function , emotional function , fatigue , nausea/vomiting , pain , constipation , and diarrhea ( all p < @ ) , with the jejunal interposition superior than the other two methods . three methods of digestive tract reconstruction in radical gastrectomy of gastric cancer patients can improve the health status and the quality of life in gastric cancer patients . radical proximal gastrectomy and jejunal interposition is the preferred method .
24,277,404
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to evaluate the effectiveness , safety and tolerability of a probiotic formulation containing lactobacillus acidophilus la-@ and bifidobacterium bb-@ in the prevention of antibiotic associated diarrhoea ( aad ) .", "a double-blind randomised placebo controlled multicentric trial was conducted in adults who were prescribed a seven-day course of oral antibiotic ( either cefadroxil or amoxycillin ) for a documented indication .", "the effectiveness of a @-day therapy ( concomitant with antibiotic course and seven days thereafter ) of the probiotic formulation in preventing aad was evaluated .", "safety profile was assessed by monitoring of all treatment emergent adverse events and tolerability on a global well being scale .", "the incidence of aad in the probiotic group was @ % compared to @ % in the placebo group , the difference being statistically non-significant ( p = @ ) .", "the relative risk for aad was @ with the @ % ci being @ to @ .", "the diarrhoea duration in the probiotic group was two days with an interquartile range of @ - @ days and was significantly less ( p = @ ) than the placebo group which was four days with an interquartile range of @ - @ days .", "subgroup analysis of subjects with aad showed that the incidence of severe diarrhoea ( watery stools ) was @ % in the placebo group ( @ out of @ ) compared to @ % ( @ out of @ ) in the probiotic group and this difference was significant statistically ( p < @ ) .", "four mild , non-serious , adverse events were detected ( @ % ) in the probiotic group but there were none in the placebo group .", "this randomised controlled trial shows that prophylactic administration of the probiotic formulation containing lactobacillus acidophilus la-@ and bifidobacterium bb-@ , did not effectively lower the incidence of aad in adults .", "however , compared to placebo the duration of diarrhoea in the probiotic group was significantly reduced .", "its tolerability and safety profile were good ." ]
to evaluate the effectiveness , safety and tolerability of a probiotic formulation containing lactobacillus acidophilus la-@ and bifidobacterium bb-@ in the prevention of antibiotic associated diarrhoea ( aad ) . a double-blind randomised placebo controlled multicentric trial was conducted in adults who were prescribed a seven-day course of oral antibiotic ( either cefadroxil or amoxycillin ) for a documented indication . the effectiveness of a @-day therapy ( concomitant with antibiotic course and seven days thereafter ) of the probiotic formulation in preventing aad was evaluated . safety profile was assessed by monitoring of all treatment emergent adverse events and tolerability on a global well being scale . the incidence of aad in the probiotic group was @ % compared to @ % in the placebo group , the difference being statistically non-significant ( p = @ ) . the relative risk for aad was @ with the @ % ci being @ to @ . the diarrhoea duration in the probiotic group was two days with an interquartile range of @ - @ days and was significantly less ( p = @ ) than the placebo group which was four days with an interquartile range of @ - @ days . subgroup analysis of subjects with aad showed that the incidence of severe diarrhoea ( watery stools ) was @ % in the placebo group ( @ out of @ ) compared to @ % ( @ out of @ ) in the probiotic group and this difference was significant statistically ( p < @ ) . four mild , non-serious , adverse events were detected ( @ % ) in the probiotic group but there were none in the placebo group . this randomised controlled trial shows that prophylactic administration of the probiotic formulation containing lactobacillus acidophilus la-@ and bifidobacterium bb-@ , did not effectively lower the incidence of aad in adults . however , compared to placebo the duration of diarrhoea in the probiotic group was significantly reduced . its tolerability and safety profile were good .
24,772,726
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to compare clinical and hemodynamic outcome in patients undergoing treatment of common femoral artery ( cfa ) atherosclerotic lesions by bioabsorbable stent implantation ( basi group ) or by common femoral artery endarterectomy ( cfe group ) .", "a randomized , controlled , single-center , open-label trial was initiated to compare outcomes of basi or cfe in patients with chronic atherosclerotic occlusive lesions in the cfa .", "from may @ to april @ , @ consecutive patients were recruited ; after excluding @ patients , @ patients ( @ men ; mean age @ years ) were enrolled @:@ and are the subject of this intention-to-treat interim analysis ( @ patients in each group ) .", "the primary endpoint was surgical site infections ; secondary outcome measures were technical success , hemodynamic improvement , clinical improvement , patency , limb salvage , and survival .", "there was no statistically significant difference between both groups regarding demographic data , cardiovascular risk factors , or cfa occlusions .", "the cfe patients presented with @ surgical site infections ( all minor ) vs. none in the basi group ( p = @ ) and a longer mean postoperative hospital stay of @ vs. @ days for basi patients ( p < @ ) .", "technical success rates were @ % and @ % for the basi and cfe groups , respectively .", "postoperative ankle-brachial index means were comparable ( p = @ ) .", "the @-day primary patency rates were @ % and @ % for the basi and cfe groups , respectively ( p = @ ) .", "there were @ reconstruction failures in cfe patients vs. none in the basi group ( p = @ ) ; @ failures involved initial cfa occlusions .", "at @ year , the primary and secondary patency rates were @ % vs. @ % ( p = @ ) and @ % vs. @ % ( p = @ ) for basi and cfe patients , respectively .", "limb salvage was equivalent , and survival rates were @ % and @ % for basi vs. cfe patients ( p = @ ) at @ year .", "this interim analysis suggests that basi is not an option for cfa occlusion and is only a limited option for cfa stenosis .", "clinical and hemodynamic results are comparable for basi and cfe .", "an increased rate of redo procedures in the basi patients outweighs lower surgical site infection rates compared to cfe .", "short-term patency rates are significantly worse in patients undergoing cfa stenting with basi ." ]
to compare clinical and hemodynamic outcome in patients undergoing treatment of common femoral artery ( cfa ) atherosclerotic lesions by bioabsorbable stent implantation ( basi group ) or by common femoral artery endarterectomy ( cfe group ) . a randomized , controlled , single-center , open-label trial was initiated to compare outcomes of basi or cfe in patients with chronic atherosclerotic occlusive lesions in the cfa . from may @ to april @ , @ consecutive patients were recruited ; after excluding @ patients , @ patients ( @ men ; mean age @ years ) were enrolled @:@ and are the subject of this intention-to-treat interim analysis ( @ patients in each group ) . the primary endpoint was surgical site infections ; secondary outcome measures were technical success , hemodynamic improvement , clinical improvement , patency , limb salvage , and survival . there was no statistically significant difference between both groups regarding demographic data , cardiovascular risk factors , or cfa occlusions . the cfe patients presented with @ surgical site infections ( all minor ) vs. none in the basi group ( p = @ ) and a longer mean postoperative hospital stay of @ vs. @ days for basi patients ( p < @ ) . technical success rates were @ % and @ % for the basi and cfe groups , respectively . postoperative ankle-brachial index means were comparable ( p = @ ) . the @-day primary patency rates were @ % and @ % for the basi and cfe groups , respectively ( p = @ ) . there were @ reconstruction failures in cfe patients vs. none in the basi group ( p = @ ) ; @ failures involved initial cfa occlusions . at @ year , the primary and secondary patency rates were @ % vs. @ % ( p = @ ) and @ % vs. @ % ( p = @ ) for basi and cfe patients , respectively . limb salvage was equivalent , and survival rates were @ % and @ % for basi vs. cfe patients ( p = @ ) at @ year . this interim analysis suggests that basi is not an option for cfa occlusion and is only a limited option for cfa stenosis . clinical and hemodynamic results are comparable for basi and cfe . an increased rate of redo procedures in the basi patients outweighs lower surgical site infection rates compared to cfe . short-term patency rates are significantly worse in patients undergoing cfa stenting with basi .
25,101,576
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to assess the interest of specifically targeting brodmann areas ( ba ) @ or @ for rtms treatment of depression .", "patients with treatment-resistant depression were randomly assigned to two treatment groups to receive either rtms on ba @ or on ba @ .", "each patient underwent @ sessions of @hz-rtms for @weeks .", "the hamilton and montgomery-asberg depression rating scales ( hdrs , madrs ) were used under blind conditions to assess the therapeutic response ( @ % improvement ) .", "a wilcoxon signed-rank test was used to compare the depression rating scales scores obtained before and after the @ rtms sessions for each of the two groups .", "the therapeutic results in the two groups were compared using the mann-whitney-wilcoxon test .", "we also reported the effect sizes using hedges 's g.", "fifteen patients were included .", "stimulation of both ba @ ( n = @ ) and ba @ ( n = @ ) led to similar therapeutic responses in the two groups ( with moderate effect size ) , such as the mean decrease in hdrs ( ba @ : p = @ ; ba @ : p = @ ) and madrs ( ba @ : p = @ ; ba @ : p = @ ) scores .", "our results do not come out in favor of one or the other ba .", "stimulation of ba @ and ba @ appears to be equally effective in the treatment of depression ." ]
to assess the interest of specifically targeting brodmann areas ( ba ) @ or @ for rtms treatment of depression . patients with treatment-resistant depression were randomly assigned to two treatment groups to receive either rtms on ba @ or on ba @ . each patient underwent @ sessions of @hz-rtms for @weeks . the hamilton and montgomery-asberg depression rating scales ( hdrs , madrs ) were used under blind conditions to assess the therapeutic response ( @ % improvement ) . a wilcoxon signed-rank test was used to compare the depression rating scales scores obtained before and after the @ rtms sessions for each of the two groups . the therapeutic results in the two groups were compared using the mann-whitney-wilcoxon test . we also reported the effect sizes using hedges 's g. fifteen patients were included . stimulation of both ba @ ( n = @ ) and ba @ ( n = @ ) led to similar therapeutic responses in the two groups ( with moderate effect size ) , such as the mean decrease in hdrs ( ba @ : p = @ ; ba @ : p = @ ) and madrs ( ba @ : p = @ ; ba @ : p = @ ) scores . our results do not come out in favor of one or the other ba . stimulation of ba @ and ba @ appears to be equally effective in the treatment of depression .
24,794,512
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "gastric cancer is a major contributor to cancer deaths in zambia but , as elsewhere , no preventive strategies have been identified .", "we set out to investigate the possibility of reducing gastric atrophy , a premalignant lesion , using micronutrient-antioxidant supplementation .", "we analysed @ archival samples from a randomised controlled trial of micronutrient-antioxidant supplementation carried out from @ to @ .", "participants were randomised to receive either the supplement or placebo and had been taking the allocated intervention for a mean of @ ( range @-@ ) months when the samples used in this study were taken .", "we used low pepsinogen @ to @ ( pep@ :@ ) ratio as a surrogate marker of gastric atrophy .", "a pep @:@ ratio of less than three was considered low .", "hiv serology , age , nutritional status , smoking , alcohol intake and gastric ph were also analysed .", "ethical approval was obtained from the university of zambia biomedical research ethics committee ( @-@-@ ) .", "the randomized trial was registered ( isrctn@ ) .", "the overall prevalence of low pep @:@ ratio was @/@ ( @ % ) and it did not differ between the placebo ( @/@ , @ % ) and micronutrient groups ( @/@ , @ % ; hr @ ; @ % ci @-@ @ ; p = @ ) .", "the presence of low pep @:@ ratio was not influenced by hiv infection ( hr @ ; @ % ci @-@ @ ; p = @ ) or nutritional status but it inversely correlated with gastric ph ( spearman 's rho = -@ ; p = @ ) .", "age above @ years was associated with atrophy , but neither alcohol nor smoking had any influence .", "short term micronutrient supplementation does not have any impact on pep @:@ ratio , a serological marker of gastric atrophy .", "pep @:@ ratio inversely correlates with gastric ph." ]
gastric cancer is a major contributor to cancer deaths in zambia but , as elsewhere , no preventive strategies have been identified . we set out to investigate the possibility of reducing gastric atrophy , a premalignant lesion , using micronutrient-antioxidant supplementation . we analysed @ archival samples from a randomised controlled trial of micronutrient-antioxidant supplementation carried out from @ to @ . participants were randomised to receive either the supplement or placebo and had been taking the allocated intervention for a mean of @ ( range @-@ ) months when the samples used in this study were taken . we used low pepsinogen @ to @ ( pep@ :@ ) ratio as a surrogate marker of gastric atrophy . a pep @:@ ratio of less than three was considered low . hiv serology , age , nutritional status , smoking , alcohol intake and gastric ph were also analysed . ethical approval was obtained from the university of zambia biomedical research ethics committee ( @-@-@ ) . the randomized trial was registered ( isrctn@ ) . the overall prevalence of low pep @:@ ratio was @/@ ( @ % ) and it did not differ between the placebo ( @/@ , @ % ) and micronutrient groups ( @/@ , @ % ; hr @ ; @ % ci @-@ @ ; p = @ ) . the presence of low pep @:@ ratio was not influenced by hiv infection ( hr @ ; @ % ci @-@ @ ; p = @ ) or nutritional status but it inversely correlated with gastric ph ( spearman 's rho = -@ ; p = @ ) . age above @ years was associated with atrophy , but neither alcohol nor smoking had any influence . short term micronutrient supplementation does not have any impact on pep @:@ ratio , a serological marker of gastric atrophy . pep @:@ ratio inversely correlates with gastric ph.
24,666,552
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "patients with acute coronary syndrome and certain co-morbidities may receive ticagrelor , a reversibly binding p@y ( @ ) receptor antagonist , and cyclosporine , a commonly used immunosuppressant drug .", "this study assessed the potential pharmacokinetic drug-drug interaction between ticagrelor and cyclosporine .", "in this single-centre , open-label , three-treatment , three-period crossover study ( nct@ ) , healthy volunteers ( n = @ ) randomly received each of three treatments : cyclosporine ( @ mg single oral dose ) plus ticagrelor ( @ mg single oral dose ) ; cyclosporine alone ; ticagrelor alone .", "treatments were separated by a washout period of @ days .", "plasma concentrations of ticagrelor and its active metabolite ( ar-c@xx ) and blood concentrations of cyclosporine were analyzed , and pharmacokinetic parameters were calculated .", "safety and tolerability were assessed .", "compared with ticagrelor alone , the geometric least squares mean ( lsm ) ratio ( @ % confidence interval -lsb- ci -rsb- ) for the ticagrelor area under the plasma concentration-time curve from time zero to infinity ( auc ( ) ) was @ ( @-@ @ ) , and the maximum plasma concentration ( c ( max ) ) was @ ( @-@ @ ) , in the presence of cyclosporine .", "co-administration of cyclosporine with ticagrelor significantly increased ar-c@xx auc ( ) ( @ -lsb- @-@ @ -rsb- ) and decreased c ( max ) ( @ -lsb- @-@ @ -rsb- ) .", "ticagrelor had no effect on cyclosporine pharmacokinetic parameters , as the @ % cis of the lsm ratios were all within the @-@ @ no-effect range .", "co-administration of ticagrelor and cyclosporine was generally well tolerated .", "co-administration of cyclosporine with ticagrelor increased exposure to ticagrelor and its active metabolite and had no effect on cyclosporine pharmacokinetic parameters .", "the magnitude of cyclosporine 's effect on ticagrelor pharmacokinetics does not warrant dose adjustment of ticagrelor ." ]
patients with acute coronary syndrome and certain co-morbidities may receive ticagrelor , a reversibly binding p@y ( @ ) receptor antagonist , and cyclosporine , a commonly used immunosuppressant drug . this study assessed the potential pharmacokinetic drug-drug interaction between ticagrelor and cyclosporine . in this single-centre , open-label , three-treatment , three-period crossover study ( nct@ ) , healthy volunteers ( n = @ ) randomly received each of three treatments : cyclosporine ( @ mg single oral dose ) plus ticagrelor ( @ mg single oral dose ) ; cyclosporine alone ; ticagrelor alone . treatments were separated by a washout period of @ days . plasma concentrations of ticagrelor and its active metabolite ( ar-c@xx ) and blood concentrations of cyclosporine were analyzed , and pharmacokinetic parameters were calculated . safety and tolerability were assessed . compared with ticagrelor alone , the geometric least squares mean ( lsm ) ratio ( @ % confidence interval -lsb- ci -rsb- ) for the ticagrelor area under the plasma concentration-time curve from time zero to infinity ( auc ( ) ) was @ ( @-@ @ ) , and the maximum plasma concentration ( c ( max ) ) was @ ( @-@ @ ) , in the presence of cyclosporine . co-administration of cyclosporine with ticagrelor significantly increased ar-c@xx auc ( ) ( @ -lsb- @-@ @ -rsb- ) and decreased c ( max ) ( @ -lsb- @-@ @ -rsb- ) . ticagrelor had no effect on cyclosporine pharmacokinetic parameters , as the @ % cis of the lsm ratios were all within the @-@ @ no-effect range . co-administration of ticagrelor and cyclosporine was generally well tolerated . co-administration of cyclosporine with ticagrelor increased exposure to ticagrelor and its active metabolite and had no effect on cyclosporine pharmacokinetic parameters . the magnitude of cyclosporine 's effect on ticagrelor pharmacokinetics does not warrant dose adjustment of ticagrelor .
24,861,133
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "human t cell lymphotropic virus type i-associated myelopathy/tropical spastic paraparesis ( ham/tsp ) can impact the independence and motricity of patients .", "the aims of this study were to estimate the effects of physiotherapy on the functionality of patients with ham/tsp during the stable phase of the disease using proprioceptive neuromuscular facilitation ( pnf ) and to compare two methods of treatment delivery .", "fourteen patients with human t cell lymphotropic virus type i ( htlv-i ) were randomly allocated into two groups .", "in group i ( seven patients ) , pnf was applied by the therapist , facilitating the functional activities of rolling , sitting and standing , walking and climbing and descending stairs .", "in group ii ( seven patients ) , pnf was self-administered using an elastic tube , and the same activities were facilitated .", "experiments were conducted for @h twice per week for @ weeks .", "low-back pain , a modified ashworth scale , the functional independence measure ( fim ) and the timed up and go test ( tug ) were assessed before and after the interventions .", "in the within-group evaluation , low-back pain was significantly reduced in both groups , the fim improved in group ii , and the results of the tug improved in group i.", "in the inter-group analysis , only the tone was lower in group ii than in group i.", "both pnf protocols were effective in treating patients with ham/tsp ." ]
human t cell lymphotropic virus type i-associated myelopathy/tropical spastic paraparesis ( ham/tsp ) can impact the independence and motricity of patients . the aims of this study were to estimate the effects of physiotherapy on the functionality of patients with ham/tsp during the stable phase of the disease using proprioceptive neuromuscular facilitation ( pnf ) and to compare two methods of treatment delivery . fourteen patients with human t cell lymphotropic virus type i ( htlv-i ) were randomly allocated into two groups . in group i ( seven patients ) , pnf was applied by the therapist , facilitating the functional activities of rolling , sitting and standing , walking and climbing and descending stairs . in group ii ( seven patients ) , pnf was self-administered using an elastic tube , and the same activities were facilitated . experiments were conducted for @h twice per week for @ weeks . low-back pain , a modified ashworth scale , the functional independence measure ( fim ) and the timed up and go test ( tug ) were assessed before and after the interventions . in the within-group evaluation , low-back pain was significantly reduced in both groups , the fim improved in group ii , and the results of the tug improved in group i. in the inter-group analysis , only the tone was lower in group ii than in group i. both pnf protocols were effective in treating patients with ham/tsp .
24,603,733
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to observe treatment effects and safety of fluvoxamine combined with oxycodone prolonged-release tablets in treating patients with moderate to severe cancer pain .", "patients confirmed pathologically with cancer and complicated with moderate to severe pain , were divided into control and experimental groups .", "oxycodone prolonged-release tablets , with or without fluvoxamine , were administrated to all study patients until pain relief .", "degree of pain relief , dose of oxycodone prolonged-release tablets , side effects and quality of life were compared before and after treatment .", "in total , @ patients were recruited .", "no statistically significant difference was detected regarding age , gender , types of cancer , kps between two groups of patients ( p > @ ) .", "baseline pain score of patients with moderate pain in treatment and control group was @ and @ , respectively ; and decreased to @ and @ after treatment , respectively .", "pain intensity was significantly reduced in the treatment group ( p = @ ) .", "average daily consumption of oxycodone prolonged - release tablets was ( @ ) mg and ( @ @ ) mg respectively , which is lower in treatment grpup than in control group , but the difference was not statistically significant ( p = @ ) .", "baseline pain score of patients with severe pain in treatment and control groups were @ and @ , respectively ; and pain intensity after treatment decreased to @ and @ .", "pain intensity was significantly reduced in the treatment group , with statistical significance ( p = @ ) .", "average daily consumption of oxycodone prolonged-release tablets was ( @ ) mg and ( @ ) mg , respectively , which is lower in treatment group than in control group , and the difference was statistically significant ( p = @ ) .", "in terms of quality of life , patients in treatment group had better performance status , daily activity , mood , and sleep than that in control group ( p < @ ) .", "patients in two groups had similar side effects , eg. , constipation , nausea/vomiting , lethargy , dizziness , itchy skin , dysuria , and ataxia .", "lower incidence of nausea/vomiting , lethargy , was obtained from patients in treatment than in control group , while significant low constipation was observed in treatment than in control group ( @ % vs @ % , p = @ ) .", "fluvoxamine combined with oxycodone prolonged-release tablets could be more effective in treating patients with cancer pain , and could reduce the dosage of oxycodone prolonged-release tablets and thus be associated with lower side effects , and improved quality of life ." ]
to observe treatment effects and safety of fluvoxamine combined with oxycodone prolonged-release tablets in treating patients with moderate to severe cancer pain . patients confirmed pathologically with cancer and complicated with moderate to severe pain , were divided into control and experimental groups . oxycodone prolonged-release tablets , with or without fluvoxamine , were administrated to all study patients until pain relief . degree of pain relief , dose of oxycodone prolonged-release tablets , side effects and quality of life were compared before and after treatment . in total , @ patients were recruited . no statistically significant difference was detected regarding age , gender , types of cancer , kps between two groups of patients ( p > @ ) . baseline pain score of patients with moderate pain in treatment and control group was @ and @ , respectively ; and decreased to @ and @ after treatment , respectively . pain intensity was significantly reduced in the treatment group ( p = @ ) . average daily consumption of oxycodone prolonged - release tablets was ( @ ) mg and ( @ @ ) mg respectively , which is lower in treatment grpup than in control group , but the difference was not statistically significant ( p = @ ) . baseline pain score of patients with severe pain in treatment and control groups were @ and @ , respectively ; and pain intensity after treatment decreased to @ and @ . pain intensity was significantly reduced in the treatment group , with statistical significance ( p = @ ) . average daily consumption of oxycodone prolonged-release tablets was ( @ ) mg and ( @ ) mg , respectively , which is lower in treatment group than in control group , and the difference was statistically significant ( p = @ ) . in terms of quality of life , patients in treatment group had better performance status , daily activity , mood , and sleep than that in control group ( p < @ ) . patients in two groups had similar side effects , eg. , constipation , nausea/vomiting , lethargy , dizziness , itchy skin , dysuria , and ataxia . lower incidence of nausea/vomiting , lethargy , was obtained from patients in treatment than in control group , while significant low constipation was observed in treatment than in control group ( @ % vs @ % , p = @ ) . fluvoxamine combined with oxycodone prolonged-release tablets could be more effective in treating patients with cancer pain , and could reduce the dosage of oxycodone prolonged-release tablets and thus be associated with lower side effects , and improved quality of life .
25,556,490
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "we hypothesized that the optimization of renal haemodynamics by maintaining a high level of mean arterial blood pressure ( map ) during cardiopulmonary bypass ( cpb ) could reduce the rate of acute kidney injury ( aki ) in high-risk patients .", "in this randomized , controlled study , we enrolled @ patients scheduled for elective cardiac surgery under cardiopulmonary bypass .", "all had known risk factors of aki : serum creatinine clearance between @ and @ ml/min for @ m ( @ ) or two factors among the following : age > @ years , diabetes mellitus , diffuse atherosclerosis .", "after a standardized fluid loading , the map was maintained between @-@ mmhg during cpb with norepinephrine ( high pressure , n = @ ) versus @-@ mmhg in the control ( n = @ ) .", "aki was defined by a @ % increased of serum creatinine ( scr ) .", "we further tested others definitions for aki : rifle classification , @ % rise of scr and the need for haemodialysis .", "the pressure endpoints were achieved in both the high pressure ( @ @ mmhg ) and the control groups ( @ @ mmhg ; p < @ ) .", "the rate of aki did not differ by group ( @ % vs. @ % ; p = @ ) , whatever the criteria used for aki .", "the length of stay in hospital ( @ days -lsb- @-@ @ -rsb- vs. @ -lsb- @-@ @ -rsb- ) and the rate of death at day @ ( @ % vs. @ % ) and at six months ( @ % vs. @ % ) did not differ between the groups .", "maintaining a high level of map ( on average ) during normothermic cpb does not reduce the risk of postoperative aki .", "it does not alter the length of hospital stay or the mortality rate ." ]
we hypothesized that the optimization of renal haemodynamics by maintaining a high level of mean arterial blood pressure ( map ) during cardiopulmonary bypass ( cpb ) could reduce the rate of acute kidney injury ( aki ) in high-risk patients . in this randomized , controlled study , we enrolled @ patients scheduled for elective cardiac surgery under cardiopulmonary bypass . all had known risk factors of aki : serum creatinine clearance between @ and @ ml/min for @ m ( @ ) or two factors among the following : age > @ years , diabetes mellitus , diffuse atherosclerosis . after a standardized fluid loading , the map was maintained between @-@ mmhg during cpb with norepinephrine ( high pressure , n = @ ) versus @-@ mmhg in the control ( n = @ ) . aki was defined by a @ % increased of serum creatinine ( scr ) . we further tested others definitions for aki : rifle classification , @ % rise of scr and the need for haemodialysis . the pressure endpoints were achieved in both the high pressure ( @ @ mmhg ) and the control groups ( @ @ mmhg ; p < @ ) . the rate of aki did not differ by group ( @ % vs. @ % ; p = @ ) , whatever the criteria used for aki . the length of stay in hospital ( @ days -lsb- @-@ @ -rsb- vs. @ -lsb- @-@ @ -rsb- ) and the rate of death at day @ ( @ % vs. @ % ) and at six months ( @ % vs. @ % ) did not differ between the groups . maintaining a high level of map ( on average ) during normothermic cpb does not reduce the risk of postoperative aki . it does not alter the length of hospital stay or the mortality rate .
24,619,062
[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the composition of fatty acids in a diet may differentially affect metabolism , thus playing a role in the development of obesity .", "our purpose was to study the effects of three high-fat ( hf ) meals with different dietary fatty acid compositions on the thermic effect of meal ( tem ) and substrate oxidation in obese premenopausal women .", "@ healthy obese women , aged @-@ years , participated in a single-blinded randomized cross-over study , in which they consumed isocaloric hf meals ( @ % of energy from fat ) rich in either saturated fat ( sfa ) , monounsaturated fat ( mufa ) or polyunsaturated fat ( pufa ) .", "indirect calorimetry was used to measure respiratory gases for a @-hour postprandial period .", "data collected was used to determine respiratory exchange ratio ( rer ) for assessing substrate oxidation , and energy expenditure for the determination of tem .", "there was a significant time effect on both substrate oxidation and tem ( p < @ ) .", "with and without using rmr as a covariate , there were no significant differences in tem between test meals ( tem of @ vs @ kcal @ h for high-mufa vs. high-sfa meals , respectively , p = @ ) .", "no treatment difference was found for postprandial substrate utilization ( @ , @ and @ g of fat oxidation following sfa , mufa , and pufa-rich hf meals , respectively ; @ , @ and @ g of carbohydrate oxidation following sfa , mufa , and pufa-rich hf meals , respectively ) .", "in premenopausal obese women , hf meals rich in either mufas , pufas , or sfas did not differentially affect tem or postprandial substrate oxidation ." ]
the composition of fatty acids in a diet may differentially affect metabolism , thus playing a role in the development of obesity . our purpose was to study the effects of three high-fat ( hf ) meals with different dietary fatty acid compositions on the thermic effect of meal ( tem ) and substrate oxidation in obese premenopausal women . @ healthy obese women , aged @-@ years , participated in a single-blinded randomized cross-over study , in which they consumed isocaloric hf meals ( @ % of energy from fat ) rich in either saturated fat ( sfa ) , monounsaturated fat ( mufa ) or polyunsaturated fat ( pufa ) . indirect calorimetry was used to measure respiratory gases for a @-hour postprandial period . data collected was used to determine respiratory exchange ratio ( rer ) for assessing substrate oxidation , and energy expenditure for the determination of tem . there was a significant time effect on both substrate oxidation and tem ( p < @ ) . with and without using rmr as a covariate , there were no significant differences in tem between test meals ( tem of @ vs @ kcal @ h for high-mufa vs. high-sfa meals , respectively , p = @ ) . no treatment difference was found for postprandial substrate utilization ( @ , @ and @ g of fat oxidation following sfa , mufa , and pufa-rich hf meals , respectively ; @ , @ and @ g of carbohydrate oxidation following sfa , mufa , and pufa-rich hf meals , respectively ) . in premenopausal obese women , hf meals rich in either mufas , pufas , or sfas did not differentially affect tem or postprandial substrate oxidation .
25,446,217
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "selective serotonin reuptake inhibitors improve cognition in patients with stroke and increase the expression of brain-derived neurotrophic factor ( bdnf ) in the rat hippocampus .", "however , the effects of selective serotonin reuptake inhibitors on cognition and serum bdnf levels in patients with vascular dementia are largely unknown .", "we performed an open-label study to investigate the effects of fluoxetine , a selective serotonin reuptake inhibitor , on cognition and serum bdnf levels in patients with vascular dementia .", "fifty patients with vascular dementia were randomly allocated to receive fluoxetine ( @ mg/day ; n = @ ) or no fluoxetine ( control group ; n = @ ) for @ weeks .", "both groups received secondary prevention of stroke .", "serum bdnf level , mini-mental state examination ( mmse ) score , ten-point clock drawing score , and digit span test and verbal fluency test scores were measured at baseline and at week @ in the both groups .", "the baseline serum bdnf level correlated significantly with the mmse score .", "mmse score , ten-point clock drawing score , and serum bdnf level increased significantly in the fluoxetine group but not in the control group .", "the increase in serum bdnf level correlated with the increase in mmse score in the fluoxetine group .", "fluoxetine may potentially improve cognition in patients with vascular dementia and requires further investigation .", "bdnf may play an important role in cognitive recovery ." ]
selective serotonin reuptake inhibitors improve cognition in patients with stroke and increase the expression of brain-derived neurotrophic factor ( bdnf ) in the rat hippocampus . however , the effects of selective serotonin reuptake inhibitors on cognition and serum bdnf levels in patients with vascular dementia are largely unknown . we performed an open-label study to investigate the effects of fluoxetine , a selective serotonin reuptake inhibitor , on cognition and serum bdnf levels in patients with vascular dementia . fifty patients with vascular dementia were randomly allocated to receive fluoxetine ( @ mg/day ; n = @ ) or no fluoxetine ( control group ; n = @ ) for @ weeks . both groups received secondary prevention of stroke . serum bdnf level , mini-mental state examination ( mmse ) score , ten-point clock drawing score , and digit span test and verbal fluency test scores were measured at baseline and at week @ in the both groups . the baseline serum bdnf level correlated significantly with the mmse score . mmse score , ten-point clock drawing score , and serum bdnf level increased significantly in the fluoxetine group but not in the control group . the increase in serum bdnf level correlated with the increase in mmse score in the fluoxetine group . fluoxetine may potentially improve cognition in patients with vascular dementia and requires further investigation . bdnf may play an important role in cognitive recovery .
24,648,723
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "bile acid malabsorption ( bam ) - associated diarrhea is an important clinical issue in patients with crohn 's disease ( cd ) .", "we analyzed the efficacy and safety of the bile acid sequestrant colesevelam for treatment of bam-associated diarrhea in cd patients in a randomized , double-blind , placebo-controlled study .", "the primary endpoint was the proportion of patients with > @ % reduction of liquid stools/day from baseline to termination visit at week @ .", "secondary endpoints were reduction of the number of liquid stools/day , improvement of stool consistency and quality of life .", "@ patients were analyzed in the intention-to-treat ( itt ) analysis .", "the primary endpoint was reached by @ patients ( @ % ) in the colesevelam group compared to @ patients ( @ % ) in the placebo group ( risk difference rd = @ , @ % ci :[ -@ ; @ -rsb- ; p = @ ) .", "in the per-protocol analysis ( n = @ ) , the risk difference was statistically significant ( rd = @ , @ % ci : -lsb- @ ; @ -rsb- , p ( h@ : rd = @ ) = @ ; @ % ci : -lsb- @ ; @ -rsb- ) .", "regarding secondary endpoints , in the itt population colesevelam-treated patients had a significant reduction of liquid stools/day at week @ ( median @ to @ ; p = @ ) , while patients treated with placebo had no significant reduction ( median @ to @ ; p = @ ) .", "significantly more patients in the colesevelam group had improvement of stool consistency of at least one level in the bristol stool chart , as compared to the placebo group ( p = @ ) .", "we found significant differences in favor for colesevelam treatment compared to placebo treatment for cd patients with bam regarding the reduction of the number of liquid stools/day and stool consistency .", "clinicaltrials.gov number : nct@ ." ]
bile acid malabsorption ( bam ) - associated diarrhea is an important clinical issue in patients with crohn 's disease ( cd ) . we analyzed the efficacy and safety of the bile acid sequestrant colesevelam for treatment of bam-associated diarrhea in cd patients in a randomized , double-blind , placebo-controlled study . the primary endpoint was the proportion of patients with > @ % reduction of liquid stools/day from baseline to termination visit at week @ . secondary endpoints were reduction of the number of liquid stools/day , improvement of stool consistency and quality of life . @ patients were analyzed in the intention-to-treat ( itt ) analysis . the primary endpoint was reached by @ patients ( @ % ) in the colesevelam group compared to @ patients ( @ % ) in the placebo group ( risk difference rd = @ , @ % ci :[ -@ ; @ -rsb- ; p = @ ) . in the per-protocol analysis ( n = @ ) , the risk difference was statistically significant ( rd = @ , @ % ci : -lsb- @ ; @ -rsb- , p ( h@ : rd = @ ) = @ ; @ % ci : -lsb- @ ; @ -rsb- ) . regarding secondary endpoints , in the itt population colesevelam-treated patients had a significant reduction of liquid stools/day at week @ ( median @ to @ ; p = @ ) , while patients treated with placebo had no significant reduction ( median @ to @ ; p = @ ) . significantly more patients in the colesevelam group had improvement of stool consistency of at least one level in the bristol stool chart , as compared to the placebo group ( p = @ ) . we found significant differences in favor for colesevelam treatment compared to placebo treatment for cd patients with bam regarding the reduction of the number of liquid stools/day and stool consistency . clinicaltrials.gov number : nct@ .
24,953,836
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to estimate whether women who underwent mnemonic counseling had better recall of fecal incontinence therapies at @ months and if mnemonic counseling resulted in greater satisfaction with physician counseling and improvement in quality of life when compared with a group who underwent standard counseling .", "counseling-naive women with fecal incontinence were recruited from an academic urogynecology clinic .", "women underwent physical examinations , completed the quality of the physician-patient interaction , recorded fecal incontinence treatment options they recalled , and completed the fecal incontinence severity index and manchester health questionnaire immediately after counseling and again at @ months .", "ninety women consented to participate , were randomized , and completed baseline questionnaires .", "at baseline , women did not differ in age , ethnicity , education , fecal incontinence severity index , or manchester health questionnaire scores .", "after counseling , the mnemonic group reported higher satisfaction on quality of the physician-patient interaction ( @ compared with @ , p = @ ) .", "ninety percent ( @/@ ) of women followed up at @ months .", "our primary endpoint , @-month recall of fecal incontinence treatments , was not different between groups ( @ mnemonic counseling compared with @ standard counseling ; p = @ ) .", "secondary endpoints for the mnemonic group reported greater improvement on total manchester health questionnaire ( p = @ ) , emotional ( p = @ ) , sleep ( @ ) , role limitations ( p < @ ) , and physical limitations ( p = @ ) when compared with the standard group .", "fecal incontinence counseling with a mnemonic aid did not improve recall at @ months but improved patient satisfaction and quality of life at @ months ." ]
to estimate whether women who underwent mnemonic counseling had better recall of fecal incontinence therapies at @ months and if mnemonic counseling resulted in greater satisfaction with physician counseling and improvement in quality of life when compared with a group who underwent standard counseling . counseling-naive women with fecal incontinence were recruited from an academic urogynecology clinic . women underwent physical examinations , completed the quality of the physician-patient interaction , recorded fecal incontinence treatment options they recalled , and completed the fecal incontinence severity index and manchester health questionnaire immediately after counseling and again at @ months . ninety women consented to participate , were randomized , and completed baseline questionnaires . at baseline , women did not differ in age , ethnicity , education , fecal incontinence severity index , or manchester health questionnaire scores . after counseling , the mnemonic group reported higher satisfaction on quality of the physician-patient interaction ( @ compared with @ , p = @ ) . ninety percent ( @/@ ) of women followed up at @ months . our primary endpoint , @-month recall of fecal incontinence treatments , was not different between groups ( @ mnemonic counseling compared with @ standard counseling ; p = @ ) . secondary endpoints for the mnemonic group reported greater improvement on total manchester health questionnaire ( p = @ ) , emotional ( p = @ ) , sleep ( @ ) , role limitations ( p < @ ) , and physical limitations ( p = @ ) when compared with the standard group . fecal incontinence counseling with a mnemonic aid did not improve recall at @ months but improved patient satisfaction and quality of life at @ months .
25,932,833
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "hyaluronic acid ( ha ) fillers are fda approved for improving the appearance of the nasolabial folds .", "previous reports on the use of ha for this treatment have focused on injections directly into the location of the desired correction .", "to our knowledge , a study has not been done evaluating the efficacy of injecting a low volume of ha into the adjacent area of volume loss to correct both volume loss and adjacent lines .", "the objective of this study was to compare the effectiveness and safety of three ha injection protocols including deep dermal cheek injection , mid - to deep dermal local nasolabial fold injection , and both injections for the correction of nasolabial folds .", "this was a split-face , randomized study evaluating the use of three injection techniques - ( i ) deep bolus injection into the mid - to lateral cheek , ( ii ) local mid - to deep dermal injection into the nasolabial fold , and ( iii ) both deep injection into the mid - to lateral cheek and local mid - to deep dermal injection into the nasolabial fold - for the treatment of moderate to severe nasolabial folds .", "wrinkle severity and global aesthetic improvement scales were measured before and @-@weeks after treatment as assessed by a blinded investigator .", "patient and physician observations showed improvement both globally and in wrinkle severity score with each technique used with no statistical difference between techniques .", "patients showed a slight preference for injection to both the mid - to lateral cheek and nasolabial fold , which was associated with the greatest amount of filler product administered .", "no serious adverse events were reported .", "injection of a dermal filler , at low volumes , into either the nasolabial fold or mid - to lateral cheek results in similar improvement to the correction of the nasolabial folds ." ]
hyaluronic acid ( ha ) fillers are fda approved for improving the appearance of the nasolabial folds . previous reports on the use of ha for this treatment have focused on injections directly into the location of the desired correction . to our knowledge , a study has not been done evaluating the efficacy of injecting a low volume of ha into the adjacent area of volume loss to correct both volume loss and adjacent lines . the objective of this study was to compare the effectiveness and safety of three ha injection protocols including deep dermal cheek injection , mid - to deep dermal local nasolabial fold injection , and both injections for the correction of nasolabial folds . this was a split-face , randomized study evaluating the use of three injection techniques - ( i ) deep bolus injection into the mid - to lateral cheek , ( ii ) local mid - to deep dermal injection into the nasolabial fold , and ( iii ) both deep injection into the mid - to lateral cheek and local mid - to deep dermal injection into the nasolabial fold - for the treatment of moderate to severe nasolabial folds . wrinkle severity and global aesthetic improvement scales were measured before and @-@weeks after treatment as assessed by a blinded investigator . patient and physician observations showed improvement both globally and in wrinkle severity score with each technique used with no statistical difference between techniques . patients showed a slight preference for injection to both the mid - to lateral cheek and nasolabial fold , which was associated with the greatest amount of filler product administered . no serious adverse events were reported . injection of a dermal filler , at low volumes , into either the nasolabial fold or mid - to lateral cheek results in similar improvement to the correction of the nasolabial folds .
24,910,271
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to determine whether vibratory stimulation would decrease pain experienced by patients during corticosteroid injection for trigger finger .", "a total of @ trigger finger injections were randomized to @ of @ cohorts .", "with the injection , patients received no vibration ( control group ) , ultrasound vibration ( sham control group ) , or vibration ( experimental group ) .", "we used a commercial handheld massaging device to provide a vibratory stimulus for the experimental group .", "we obtained visual analog scale ( vas ) pain scores before and after injection to assess anticipated pain and actual pain experienced .", "anticipated pain and actual pain did not differ significantly among groups .", "anticipated vas pain scores were @ , @ , and @ and actual vas pain scores were @ , @ , and @ for the vibration , control , and sham control groups , respectively .", "when normalized using anchoring vas pain scores for `` stubbing a toe '' or `` paper cut , '' no between-group differences remained in injection pain scores .", "concomitant vibratory stimulation does not reduce pain experienced during corticosteroid injections for trigger finger .", "therapeutic i." ]
to determine whether vibratory stimulation would decrease pain experienced by patients during corticosteroid injection for trigger finger . a total of @ trigger finger injections were randomized to @ of @ cohorts . with the injection , patients received no vibration ( control group ) , ultrasound vibration ( sham control group ) , or vibration ( experimental group ) . we used a commercial handheld massaging device to provide a vibratory stimulus for the experimental group . we obtained visual analog scale ( vas ) pain scores before and after injection to assess anticipated pain and actual pain experienced . anticipated pain and actual pain did not differ significantly among groups . anticipated vas pain scores were @ , @ , and @ and actual vas pain scores were @ , @ , and @ for the vibration , control , and sham control groups , respectively . when normalized using anchoring vas pain scores for `` stubbing a toe '' or `` paper cut , '' no between-group differences remained in injection pain scores . concomitant vibratory stimulation does not reduce pain experienced during corticosteroid injections for trigger finger . therapeutic i.
25,218,139
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "METHODS" ]
[ "depression is a leading cause of disability worldwide and , although efficacious treatments are available , their efficacy is suboptimal and recurrence of symptoms is common .", "effective preventive strategies could reduce disability and the long term social and health complications associated with the disorder , but current options are limited .", "cognitive bias modification ( cbm ) is a novel , simple , and safe intervention that addresses attentional and interpretive biases associated with anxiety , dysphoria , and depression .", "the primary aim of this trial is to determine if cbm decreases the one-year onset of a major depressive episode among adults with subsyndromal depression .", "this randomised controlled trial will recruit @ adults with subsyndromal symptoms of depression living in the australian community ( parallel design , @:@ allocation ratio ) .", "participants will be free of clinically significant symptoms of depression and of psychotic disorders , sensory and cognitive impairment , and risky alcohol use .", "the cbm intervention will target attentional and interpretive biases associated with depressive symptoms .", "the sessions will be delivered via the internet over a period of @ weeks .", "the primary outcome of interest is the onset of a major depressive episode according the dsm-iv-tr criteria over a @-month period .", "secondary outcomes of interest include change in the severity of depressive symptoms as measured by the patient health questionnaire ( phq-@ ) , use of antidepressants or benzodiazepines , and changes in attention and interpretive biases .", "the assessment of outcomes will take place @ , @ , @ , and @ months after randomisation and will occur via the internet .", "we propose to test the efficacy of an innovative intervention that is well grounded in theory and for which increasing empirical evidence for an effect on mood is available .", "the intervention is simple , inexpensive , easy to access , and could be easily rolled out into practice if our findings confirm a role for cbm in the prevention of depression .", "australian and new zealand clinical trials registry actrn@ .", "date : @th december @ ." ]
depression is a leading cause of disability worldwide and , although efficacious treatments are available , their efficacy is suboptimal and recurrence of symptoms is common . effective preventive strategies could reduce disability and the long term social and health complications associated with the disorder , but current options are limited . cognitive bias modification ( cbm ) is a novel , simple , and safe intervention that addresses attentional and interpretive biases associated with anxiety , dysphoria , and depression . the primary aim of this trial is to determine if cbm decreases the one-year onset of a major depressive episode among adults with subsyndromal depression . this randomised controlled trial will recruit @ adults with subsyndromal symptoms of depression living in the australian community ( parallel design , @:@ allocation ratio ) . participants will be free of clinically significant symptoms of depression and of psychotic disorders , sensory and cognitive impairment , and risky alcohol use . the cbm intervention will target attentional and interpretive biases associated with depressive symptoms . the sessions will be delivered via the internet over a period of @ weeks . the primary outcome of interest is the onset of a major depressive episode according the dsm-iv-tr criteria over a @-month period . secondary outcomes of interest include change in the severity of depressive symptoms as measured by the patient health questionnaire ( phq-@ ) , use of antidepressants or benzodiazepines , and changes in attention and interpretive biases . the assessment of outcomes will take place @ , @ , @ , and @ months after randomisation and will occur via the internet . we propose to test the efficacy of an innovative intervention that is well grounded in theory and for which increasing empirical evidence for an effect on mood is available . the intervention is simple , inexpensive , easy to access , and could be easily rolled out into practice if our findings confirm a role for cbm in the prevention of depression . australian and new zealand clinical trials registry actrn@ . date : @th december @ .
25,012,399
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND" ]
[ "to observe the clinical effectiveness of qilin pills combined with sertraline in the treatment of secondary non-consolidated kidney qi premature ejaculation ( pe ) .", "a total of @ patients with secondary non-consolidated kidney qi pe were randomly assigned to groups a ( aged -lsb- @ @ -rsb- yr ) , b ( aged -lsb- @ @ -rsb- yr ) , and c ( aged -lsb- @ @ -rsb- yr ) in the ratio of @:@:@ to receive qilin pills ( once @ g , bid ) , sertraline ( once @ mg , qd ) , and qilin pills plus sertraline , respectively , all for @ weeks .", "the intravaginal ejaculatory latency time ( ielt ) and pe diagnostic tool ( pedt ) scores were obtained before and after medication and at @ month after drug withdrawal , and comparative analyses were made among the three groups of patients .", "the ielt was dramatically prolonged in groups a , b , and c after treatment ( -lsb- @ @ -rsb- , -lsb- @ @ -rsb- , and -lsb- @ @ -rsb- min ) and at @ month after drug withdrawal ( -lsb- @ @ -rsb- , -lsb- @ @ -rsb- , and -lsb- @ @ -rsb- min ) as compared with the baseline ( -lsb- @ @ -rsb- , -lsb- @ @ -rsb- , and -lsb- @ @ -rsb- min ) ( p < @ ) , even longer in group c than in a and b ( p < @ ) .", "the pedt scores of the three groups were @ @ , @ @ , and @ @ after treatment and @ @ , @ @ , and @ @ at @ month after drug withdrawal , significantly improved in comparison with @ @ , @ @ , and @ @ before treatment ( p < @ ) , even more significantly in group c than in a and b ( p < @ ) .", "qilin pills combined with sertraline has a definite efficacy in the treatment of secondary non-consolidated kidney qi pe and therefore deserves wide clinical application ." ]
to observe the clinical effectiveness of qilin pills combined with sertraline in the treatment of secondary non-consolidated kidney qi premature ejaculation ( pe ) . a total of @ patients with secondary non-consolidated kidney qi pe were randomly assigned to groups a ( aged -lsb- @ @ -rsb- yr ) , b ( aged -lsb- @ @ -rsb- yr ) , and c ( aged -lsb- @ @ -rsb- yr ) in the ratio of @:@:@ to receive qilin pills ( once @ g , bid ) , sertraline ( once @ mg , qd ) , and qilin pills plus sertraline , respectively , all for @ weeks . the intravaginal ejaculatory latency time ( ielt ) and pe diagnostic tool ( pedt ) scores were obtained before and after medication and at @ month after drug withdrawal , and comparative analyses were made among the three groups of patients . the ielt was dramatically prolonged in groups a , b , and c after treatment ( -lsb- @ @ -rsb- , -lsb- @ @ -rsb- , and -lsb- @ @ -rsb- min ) and at @ month after drug withdrawal ( -lsb- @ @ -rsb- , -lsb- @ @ -rsb- , and -lsb- @ @ -rsb- min ) as compared with the baseline ( -lsb- @ @ -rsb- , -lsb- @ @ -rsb- , and -lsb- @ @ -rsb- min ) ( p < @ ) , even longer in group c than in a and b ( p < @ ) . the pedt scores of the three groups were @ @ , @ @ , and @ @ after treatment and @ @ , @ @ , and @ @ at @ month after drug withdrawal , significantly improved in comparison with @ @ , @ @ , and @ @ before treatment ( p < @ ) , even more significantly in group c than in a and b ( p < @ ) . qilin pills combined with sertraline has a definite efficacy in the treatment of secondary non-consolidated kidney qi pe and therefore deserves wide clinical application .
26,117,944
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "tinnitus affects more than @ million people in the unites states , and cognitive difficulties are among the most commonly associated symptoms .", "to test the feasibility and preliminarily the effectiveness of using a putative neuroplasticity-enhancing drug , d-cycloserine , to facilitate a computer-assisted ct program for improving tinnitus bother and related cognitive difficulties .", "double-blind , randomized clinical trial at an outpatient academic medical center of @ participants aged @ to @ years with subjective , unilateral or bilateral , nonpulsatile tinnitus of at least @ months ' duration .", "five weeks of twice-weekly computer-based ct with either @ mg d-cycloserine or placebo orally prior to computer ct sessions .", "difference in the change in tinnitus functional index ( tfi ) score between the @ groups .", "after excluding @ participant lost to follow-up , @ who withdrew , @ who did not complete @ % of sessions , and @ outlier , @ participants were included in the analysis .", "the d-cycloserine plus ct group showed a significant improvement in median tfi score ( -@ -lsb- @ % ci , -@ to -@ -rsb- ) and self-reported cognitive deficits ( -@ -lsb- @ % ci , -@ to -@ -rsb- ) , but the placebo group did not ( -@ -lsb- @ % ci , -@ to @ -rsb- and -@ -lsb- @ % ci , -@ to @ -rsb- , respectively ) .", "after controlling for age and duration of tinnitus , there was no significant difference in tfi score change between the @ groups ( p = @ ) .", "after confounders were controlled for , the d-cycloserine group demonstrated a significantly greater improvement in self-reported cognitive deficits as compared with the placebo group ( p = @ ) .", "no serious adverse events were reported .", "use of a computer-based ct program with a putative neuroplasticity-sensitizing drug , d-cycloserine , was feasible and well tolerated .", "with the limited sample size , the adjuvant use of d-cycloserine was no more effective than placebo at improving tinnitus bother .", "the finding that d-cycloserine use was more effective than placebo at improving self-reported cognitive difficulties could be important given the high rate of concern for cognitive deficits in patients with tinnitus .", "d-cycloserine and other putative neuroplasticity-facilitating agents could be investigated in the future as a strategy to enhance neuroplasticity-based tinnitus treatments .", "clinicaltrials.gov identifier : nct@ ." ]
tinnitus affects more than @ million people in the unites states , and cognitive difficulties are among the most commonly associated symptoms . to test the feasibility and preliminarily the effectiveness of using a putative neuroplasticity-enhancing drug , d-cycloserine , to facilitate a computer-assisted ct program for improving tinnitus bother and related cognitive difficulties . double-blind , randomized clinical trial at an outpatient academic medical center of @ participants aged @ to @ years with subjective , unilateral or bilateral , nonpulsatile tinnitus of at least @ months ' duration . five weeks of twice-weekly computer-based ct with either @ mg d-cycloserine or placebo orally prior to computer ct sessions . difference in the change in tinnitus functional index ( tfi ) score between the @ groups . after excluding @ participant lost to follow-up , @ who withdrew , @ who did not complete @ % of sessions , and @ outlier , @ participants were included in the analysis . the d-cycloserine plus ct group showed a significant improvement in median tfi score ( -@ -lsb- @ % ci , -@ to -@ -rsb- ) and self-reported cognitive deficits ( -@ -lsb- @ % ci , -@ to -@ -rsb- ) , but the placebo group did not ( -@ -lsb- @ % ci , -@ to @ -rsb- and -@ -lsb- @ % ci , -@ to @ -rsb- , respectively ) . after controlling for age and duration of tinnitus , there was no significant difference in tfi score change between the @ groups ( p = @ ) . after confounders were controlled for , the d-cycloserine group demonstrated a significantly greater improvement in self-reported cognitive deficits as compared with the placebo group ( p = @ ) . no serious adverse events were reported . use of a computer-based ct program with a putative neuroplasticity-sensitizing drug , d-cycloserine , was feasible and well tolerated . with the limited sample size , the adjuvant use of d-cycloserine was no more effective than placebo at improving tinnitus bother . the finding that d-cycloserine use was more effective than placebo at improving self-reported cognitive difficulties could be important given the high rate of concern for cognitive deficits in patients with tinnitus . d-cycloserine and other putative neuroplasticity-facilitating agents could be investigated in the future as a strategy to enhance neuroplasticity-based tinnitus treatments . clinicaltrials.gov identifier : nct@ .
25,356,570
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "tracheal intubation results in an alteration of the laryngeal mucosa which can lead to undesirable effects at emergence from anaesthesia .", "local anesthetics , when administered topically , may represent an interesting alternative to reduce these side effects .", "in this trial , we aimed to evaluate the effect of lidocaine in preventing tracheal intubation related side effects at emergence from anaesthesia , when instilled onto the glottis before intubation or used to inflate the endotracheal tube cuff .", "eighty patients scheduled to elective surgery of less than @ minutes under general anaesthesia were enrolled in this prospective , randomized , controlled , double blind study .", "as they receive instillation of @ % lidocaine or saline onto the glottis before intubation , and as they have their endotracheal tube cuff filled with @ % lidocaine or saline , the patients were randomized in four groups .", "s-s ( saline instillation and saline in the cuff ) ; s-lido ( saline instillation and lidocaine in the cuff ) ; lido-s ( lidocaine instillation and saline in the cuff ) ; lido-lido ( lidocaine instillation and lidocaine in the cuff ) .", "the primary outcome was the incidence of coughing before extubation .", "the secondary outcomes were sore throat scores at h@ and h@ postoperatively and incidence of dysphagia , dysphonia and laryngeal dyspnea during the first @ hours .", "coughing occurred in @ % , @ % , @ % and @ % of patients in s-s , s-lido , lido-s and lido-lido groups respectively .", "when compared to s-s group , the incidence of coughing was significantly reduced in lido-s and lido-lido groups but not in s-lido group ( p@ = @ ; p@ = @ ; p@ = @ respectively ) .", "sore throat scores at h@ and h@ were significantly lower in lido-s and lido-lido groups ( p@ = @ and p@ = @ ) .", "there was no significant difference between groups regarding the incidence of dysphagia , dysphonia and laryngeal dyspnea .", "when instilled onto the glottis before intubation , lidocaine reduced both the incidence of coughing and the severity of postoperative sore throat in surgery of less than @ minutes .", "intracuff lidocaine was not effective to reduce neither coughing nor sore throat severity ." ]
tracheal intubation results in an alteration of the laryngeal mucosa which can lead to undesirable effects at emergence from anaesthesia . local anesthetics , when administered topically , may represent an interesting alternative to reduce these side effects . in this trial , we aimed to evaluate the effect of lidocaine in preventing tracheal intubation related side effects at emergence from anaesthesia , when instilled onto the glottis before intubation or used to inflate the endotracheal tube cuff . eighty patients scheduled to elective surgery of less than @ minutes under general anaesthesia were enrolled in this prospective , randomized , controlled , double blind study . as they receive instillation of @ % lidocaine or saline onto the glottis before intubation , and as they have their endotracheal tube cuff filled with @ % lidocaine or saline , the patients were randomized in four groups . s-s ( saline instillation and saline in the cuff ) ; s-lido ( saline instillation and lidocaine in the cuff ) ; lido-s ( lidocaine instillation and saline in the cuff ) ; lido-lido ( lidocaine instillation and lidocaine in the cuff ) . the primary outcome was the incidence of coughing before extubation . the secondary outcomes were sore throat scores at h@ and h@ postoperatively and incidence of dysphagia , dysphonia and laryngeal dyspnea during the first @ hours . coughing occurred in @ % , @ % , @ % and @ % of patients in s-s , s-lido , lido-s and lido-lido groups respectively . when compared to s-s group , the incidence of coughing was significantly reduced in lido-s and lido-lido groups but not in s-lido group ( p@ = @ ; p@ = @ ; p@ = @ respectively ) . sore throat scores at h@ and h@ were significantly lower in lido-s and lido-lido groups ( p@ = @ and p@ = @ ) . there was no significant difference between groups regarding the incidence of dysphagia , dysphonia and laryngeal dyspnea . when instilled onto the glottis before intubation , lidocaine reduced both the incidence of coughing and the severity of postoperative sore throat in surgery of less than @ minutes . intracuff lidocaine was not effective to reduce neither coughing nor sore throat severity .
24,879,167
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to verify the effect of bloodletting therapy at jing-well points and semen coicis on patients with traumatic cerebral infarction .", "ninety patients were randomized into a bloodletting therapy at jing-well points group ( bloodletting group ) , a semen coicis group and a comprehensive therapy group , @ cases in each one .", "the conventional basic medication was applied in all of the three groups .", "in the bloodletting group , the bloodletting therapy was done at twelve jing-well points with three-edged needle , @ drops of blood required at each one , three times a day .", "in the semen coicis group , the semen coicis preparation was applied via nasal feeding or oral administration , @ g each day , three times a day .", "in the comprehensive therapy group , the bloodletting therapy at twelve jing-well points and semen coicis preparation were used in combination and the methods were same as the above two groups .", "after @ weeks of treatment , the efficacy was assessed with nerve function defectscale ( nds ) .", "fugl-meyer scale of the upper and lower limb function was used to evaluate the motor function of the affected limbs of the patients before and after treatment .", "the scores of fugl-meyer scale of the upper and lower limb function were increased apparently after treatment in the patients of every group ( p < @ , p < @ ) .", "the score increase was much more obvious in the bloodletting group and the comprehensive therapy group as compared with the semen coicis group ( all p < @ ) .", "the result in the comprehensive therapy group was superior to the bloodletting group ( all p < @ ) .", "the total effective rates of nds in the comprehensive therapy group , bloodletting group and semen coicis group were @ % ( @/@ ) , @ % ( @/@ ) and @ % ( @/@ ) separately .", "the result in the comprehensive therapy group was higher apparently than those in the bloodletting group and semen coicis group separately ( both p < @ ) .", "the result in the bloodletting group was better than that in the semen coicis group ( p < @ ) .", "the bloodletting therapy at jing-well points and semen coicis alleviate apparently nerve function defect , improve the motor function of the affected limbs and achieve the better efficacy ." ]
to verify the effect of bloodletting therapy at jing-well points and semen coicis on patients with traumatic cerebral infarction . ninety patients were randomized into a bloodletting therapy at jing-well points group ( bloodletting group ) , a semen coicis group and a comprehensive therapy group , @ cases in each one . the conventional basic medication was applied in all of the three groups . in the bloodletting group , the bloodletting therapy was done at twelve jing-well points with three-edged needle , @ drops of blood required at each one , three times a day . in the semen coicis group , the semen coicis preparation was applied via nasal feeding or oral administration , @ g each day , three times a day . in the comprehensive therapy group , the bloodletting therapy at twelve jing-well points and semen coicis preparation were used in combination and the methods were same as the above two groups . after @ weeks of treatment , the efficacy was assessed with nerve function defectscale ( nds ) . fugl-meyer scale of the upper and lower limb function was used to evaluate the motor function of the affected limbs of the patients before and after treatment . the scores of fugl-meyer scale of the upper and lower limb function were increased apparently after treatment in the patients of every group ( p < @ , p < @ ) . the score increase was much more obvious in the bloodletting group and the comprehensive therapy group as compared with the semen coicis group ( all p < @ ) . the result in the comprehensive therapy group was superior to the bloodletting group ( all p < @ ) . the total effective rates of nds in the comprehensive therapy group , bloodletting group and semen coicis group were @ % ( @/@ ) , @ % ( @/@ ) and @ % ( @/@ ) separately . the result in the comprehensive therapy group was higher apparently than those in the bloodletting group and semen coicis group separately ( both p < @ ) . the result in the bloodletting group was better than that in the semen coicis group ( p < @ ) . the bloodletting therapy at jing-well points and semen coicis alleviate apparently nerve function defect , improve the motor function of the affected limbs and achieve the better efficacy .
24,298,764
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to evaluate the effect of radiofrequency surgery of the soft palate on daytime sleepiness in snoring men with mild or no sleep apnea .", "randomized controlled trial .", "thirty-five men were recruited from consecutive patients referred to the ear , nose , and throat clinic due to snoring and complaints of daytime sleepiness .", "the inclusion criteria were an apnea-hypopnea index ( ahi ) of@ , male gender , and age @ to @ years .", "patients were randomized to either radiofrequency or sham surgery of the soft palate .", "all but one chose and received the option of three treatments .", "all patients participated in a follow-up , including an overnight sleep apnea recording and questionnaires @ months after the last treatment .", "the primary outcome was daytime sleepiness measured with the epworth sleepiness scale ( ess ) and other questionnaires .", "secondary outcomes were effects on the ahi and subjective snoring .", "thirty-two of @ patients-@ of @ patients in the radiofrequency surgery group and @ of @ patients in the sham surgery group-completed the study .", "no differences between the two groups in relation to the ess or ahi were found at follow-up .", "radiofrequency surgery of the soft palate has no effect on daytime sleepiness , snoring , or apnea frequency in snoring men with mild or no sleep apnea @ year after surgery .", "@b .", "laryngoscope @:@ -@ , @ ." ]
to evaluate the effect of radiofrequency surgery of the soft palate on daytime sleepiness in snoring men with mild or no sleep apnea . randomized controlled trial . thirty-five men were recruited from consecutive patients referred to the ear , nose , and throat clinic due to snoring and complaints of daytime sleepiness . the inclusion criteria were an apnea-hypopnea index ( ahi ) of@ , male gender , and age @ to @ years . patients were randomized to either radiofrequency or sham surgery of the soft palate . all but one chose and received the option of three treatments . all patients participated in a follow-up , including an overnight sleep apnea recording and questionnaires @ months after the last treatment . the primary outcome was daytime sleepiness measured with the epworth sleepiness scale ( ess ) and other questionnaires . secondary outcomes were effects on the ahi and subjective snoring . thirty-two of @ patients-@ of @ patients in the radiofrequency surgery group and @ of @ patients in the sham surgery group-completed the study . no differences between the two groups in relation to the ess or ahi were found at follow-up . radiofrequency surgery of the soft palate has no effect on daytime sleepiness , snoring , or apnea frequency in snoring men with mild or no sleep apnea @ year after surgery . @b . laryngoscope @:@ -@ , @ .
24,390,800
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "METHODS", "METHODS" ]
[ "to determine the relationship between inflammation and glucocorticoid metabolism in vivo , in a clinical study of patients with inflammatory arthritis treated with anti-tnf therapy .", "urine samples were collected from patients with rheumatoid arthritis ( ra ) and psoriatic arthritis ( psa ) as part of a multicentre study assessing responses to infliximab and etanercept .", "systemic measures of glucocorticoid metabolism were assessed by gas chromatography/mass spectrometry at weeks @ ( baseline ) , @ and @ after anti-tnf therapy .", "clinical data including das@ and c-reactive protein were also collected .", "systemic measures of @-hsd@ activity in patients with inflammatory arthritis decreased significantly following anti-tnf therapy in patients with ra and psa .", "additionally , the activity of the glucocorticoid inactivating enzyme @-reductase appeared to increase significantly .", "this study demonstrates , for the first time , that the increased @-hsd@ activity seen in patients with inflammatory arthritis is mediated through tnf .", "furthermore , the changes in related glucocorticoid metabolising enzymes suggest that there is a coordinated change in glucocorticoid metabolism which promotes higher tissue glucocorticoid levels ." ]
to determine the relationship between inflammation and glucocorticoid metabolism in vivo , in a clinical study of patients with inflammatory arthritis treated with anti-tnf therapy . urine samples were collected from patients with rheumatoid arthritis ( ra ) and psoriatic arthritis ( psa ) as part of a multicentre study assessing responses to infliximab and etanercept . systemic measures of glucocorticoid metabolism were assessed by gas chromatography/mass spectrometry at weeks @ ( baseline ) , @ and @ after anti-tnf therapy . clinical data including das@ and c-reactive protein were also collected . systemic measures of @-hsd@ activity in patients with inflammatory arthritis decreased significantly following anti-tnf therapy in patients with ra and psa . additionally , the activity of the glucocorticoid inactivating enzyme @-reductase appeared to increase significantly . this study demonstrates , for the first time , that the increased @-hsd@ activity seen in patients with inflammatory arthritis is mediated through tnf . furthermore , the changes in related glucocorticoid metabolising enzymes suggest that there is a coordinated change in glucocorticoid metabolism which promotes higher tissue glucocorticoid levels .
24,385,202
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the use of the anthropometric indices of adiposity , especially body mass index and waist circumference in the prediction of diabetes mellitus has been widely explored .", "recently , a new body composition index , the body adiposity index was proposed .", "the aim of this study was to compare the effectiveness of body mass index , waist circumference , and body adiposity index in the risk assessment for type @ diabetes mellitus .", "a total of @,@ individuals from the general population of vitoria city , brazil and @ amerindians from the aracruz indian reserve , brazil were randomly selected .", "bmi , waist circumference , and bai were determined according to a standard protocol .", "type @ diabetes mellitus was diagnosed by the presence of fasting glucose @ mg/dl or by the use of antidiabetic drugs .", "the area under the curve was similar for all anthropometric indices tested in the amerindian population , but with very different sensitivities or specificities .", "in women from the general population , the area under the curve of waist circumference was significantly higher than that of the body adiposity index .", "regarding risk assessment for type @ diabetes mellitus , the body adiposity index was a better risk predictor than body mass index and waist circumference in the amerindian population and was the index with highest odds ratio for type @ diabetes mellitus in men from the general population , while in women from the general population waist circumference was the best risk predictor .", "body adiposity index was the best risk predictor for type @ diabetes mellitus in the amerindian population and men from the general population .", "our data suggest that the body adiposity index is a useful tool for the risk assessment of type @ diabetes mellitus in admixture populations ." ]
the use of the anthropometric indices of adiposity , especially body mass index and waist circumference in the prediction of diabetes mellitus has been widely explored . recently , a new body composition index , the body adiposity index was proposed . the aim of this study was to compare the effectiveness of body mass index , waist circumference , and body adiposity index in the risk assessment for type @ diabetes mellitus . a total of @,@ individuals from the general population of vitoria city , brazil and @ amerindians from the aracruz indian reserve , brazil were randomly selected . bmi , waist circumference , and bai were determined according to a standard protocol . type @ diabetes mellitus was diagnosed by the presence of fasting glucose @ mg/dl or by the use of antidiabetic drugs . the area under the curve was similar for all anthropometric indices tested in the amerindian population , but with very different sensitivities or specificities . in women from the general population , the area under the curve of waist circumference was significantly higher than that of the body adiposity index . regarding risk assessment for type @ diabetes mellitus , the body adiposity index was a better risk predictor than body mass index and waist circumference in the amerindian population and was the index with highest odds ratio for type @ diabetes mellitus in men from the general population , while in women from the general population waist circumference was the best risk predictor . body adiposity index was the best risk predictor for type @ diabetes mellitus in the amerindian population and men from the general population . our data suggest that the body adiposity index is a useful tool for the risk assessment of type @ diabetes mellitus in admixture populations .
24,937,307
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "this study tried to determine the efficacy and safety of low-dose intracoronary unfractionated heparin ( ufh ) in elective percutaneous coronary intervention ( pci ) .", "two-hundred patients who underwent elective pci of an uncomplicated lesion were included into the study .", "the patients were assigned to either a control group ( @-@ iu/kg intravenous ufh ) or a low-dose intracoronary ufh ( @,@ iu intracoronary ufh ) group .", "at @ days , the primary end point ( composite of death , myocardial infarction , or urgent target vessel revascularization ) was similar in both groups -lsb- intracoronary ufh group , @ % ; control group , @ % ; odds ratio ; @ ( @ % ci : @ - @ ) , p = @ -rsb- .", "post-procedural myocardial injury ( according to ck-mb , p = @ ; according to tn i , p = @ ) and bleeding events ( based on timi criteria , p = @ ; based on steeple criteria , p = @ ) were similar in the control and intracoronary groups .", "the primary end point at @ months was also similar between the two groups ( p = @ ) .", "moreover , the health care cost at @ days of follow-up was lower in the intracoronary group than in the control group ( @,@ @ $ / patient vs @,@ @ $ / patient , p < @ ) .", "this pilot study suggests that elective pci could be safely performed with low-dose intracoronary ufh in the treatment of uncomplicated lesions and at a lower cost as compared to standard systemic anticoagulation.these results should be confirmed by further studies ." ]
this study tried to determine the efficacy and safety of low-dose intracoronary unfractionated heparin ( ufh ) in elective percutaneous coronary intervention ( pci ) . two-hundred patients who underwent elective pci of an uncomplicated lesion were included into the study . the patients were assigned to either a control group ( @-@ iu/kg intravenous ufh ) or a low-dose intracoronary ufh ( @,@ iu intracoronary ufh ) group . at @ days , the primary end point ( composite of death , myocardial infarction , or urgent target vessel revascularization ) was similar in both groups -lsb- intracoronary ufh group , @ % ; control group , @ % ; odds ratio ; @ ( @ % ci : @ - @ ) , p = @ -rsb- . post-procedural myocardial injury ( according to ck-mb , p = @ ; according to tn i , p = @ ) and bleeding events ( based on timi criteria , p = @ ; based on steeple criteria , p = @ ) were similar in the control and intracoronary groups . the primary end point at @ months was also similar between the two groups ( p = @ ) . moreover , the health care cost at @ days of follow-up was lower in the intracoronary group than in the control group ( @,@ @ $ / patient vs @,@ @ $ / patient , p < @ ) . this pilot study suggests that elective pci could be safely performed with low-dose intracoronary ufh in the treatment of uncomplicated lesions and at a lower cost as compared to standard systemic anticoagulation.these results should be confirmed by further studies .
25,643,432
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "varus deformity increases the risk of progression of medial compartment knee osteoarthritis .", "the aim of this study was to investigate the clinical and radiographic mid-term results of closing-wedge and opening-wedge high tibial osteotomy when used to treat this condition .", "from january @ to april @ , ninety-two patients were randomized to receive either a closing-wedge or an opening-wedge high tibial osteotomy .", "the clinical outcome and radiographic results were examined preoperatively ; at one year ; and , for the present study , at six years postoperatively .", "the outcomes that we reviewed included maintenance of the achieved correction , progression of osteoarthritis ( based on the kellgren and lawrence classification ) , severity of pain ( as assessed on a visual analog scale -lsb- vas -rsb- ) , knee function ( as measured with the hospital for special surgery -lsb- hss -rsb- score and knee injury and osteoarthritis outcome score -lsb- koos -rsb- ) , walking distance , complications , and survival with conversion to a total knee arthroplasty as the end point .", "the results were analyzed on the basis of the intention-to-treat principle .", "six years postoperatively , the mean hip-knee-ankle ( hka ) angle ( and standard deviation ) was @ @ of valgus after a closing-wedge high tibial osteotomy and @ @ of valgus after an opening-wedge high tibial osteotomy ( p = @ ) .", "in both groups , the six-year postoperative hka angles did not differ from the respective one-year postoperative angles .", "no difference in the severity of pain or in knee function was found between the two groups .", "four complications ( @ % ) occurred in the closing-wedge group and seventeen ( @ % ) , in the opening-wedge group .", "ten ( @ % ) of the patients in the closing-wedge group and three ( @ % ) in the opening-wedge group needed conversion to a total knee arthroplasty within the six-year period ( p = @ ) .", "the difference in the percentage of cases with conversion to total knee arthroplasty was @ % ( @ % confidence interval -lsb- ci -rsb- = @ to @ ) .", "in the group of patients without conversion to a total knee arthroplasty , there was no difference between the high tibial closing-wedge and opening-wedge osteotomies in terms of clinical outcomes or radiographic alignment at six years postoperatively .", "opening-wedge osteotomy was associated with more complications , but closing-wedge osteotomy was associated with more early conversions to total knee arthroplasty .", "therapeutic level i. see instructions for authors for a complete description of levels of evidence ." ]
varus deformity increases the risk of progression of medial compartment knee osteoarthritis . the aim of this study was to investigate the clinical and radiographic mid-term results of closing-wedge and opening-wedge high tibial osteotomy when used to treat this condition . from january @ to april @ , ninety-two patients were randomized to receive either a closing-wedge or an opening-wedge high tibial osteotomy . the clinical outcome and radiographic results were examined preoperatively ; at one year ; and , for the present study , at six years postoperatively . the outcomes that we reviewed included maintenance of the achieved correction , progression of osteoarthritis ( based on the kellgren and lawrence classification ) , severity of pain ( as assessed on a visual analog scale -lsb- vas -rsb- ) , knee function ( as measured with the hospital for special surgery -lsb- hss -rsb- score and knee injury and osteoarthritis outcome score -lsb- koos -rsb- ) , walking distance , complications , and survival with conversion to a total knee arthroplasty as the end point . the results were analyzed on the basis of the intention-to-treat principle . six years postoperatively , the mean hip-knee-ankle ( hka ) angle ( and standard deviation ) was @ @ of valgus after a closing-wedge high tibial osteotomy and @ @ of valgus after an opening-wedge high tibial osteotomy ( p = @ ) . in both groups , the six-year postoperative hka angles did not differ from the respective one-year postoperative angles . no difference in the severity of pain or in knee function was found between the two groups . four complications ( @ % ) occurred in the closing-wedge group and seventeen ( @ % ) , in the opening-wedge group . ten ( @ % ) of the patients in the closing-wedge group and three ( @ % ) in the opening-wedge group needed conversion to a total knee arthroplasty within the six-year period ( p = @ ) . the difference in the percentage of cases with conversion to total knee arthroplasty was @ % ( @ % confidence interval -lsb- ci -rsb- = @ to @ ) . in the group of patients without conversion to a total knee arthroplasty , there was no difference between the high tibial closing-wedge and opening-wedge osteotomies in terms of clinical outcomes or radiographic alignment at six years postoperatively . opening-wedge osteotomy was associated with more complications , but closing-wedge osteotomy was associated with more early conversions to total knee arthroplasty . therapeutic level i. see instructions for authors for a complete description of levels of evidence .
25,187,580
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "METHODS" ]
[ "concussion is a common injury in sport .", "most individuals recover in @-@days but some have persistent symptoms .", "the objective of this study was to determine if a combination of vestibular rehabilitation and cervical spine physiotherapy decreased the time until medical clearance in individuals with prolonged postconcussion symptoms .", "this study was a randomised controlled trial .", "consecutive patients with persistent symptoms of dizziness , neck pain and/or headaches following a sport-related concussion ( @-@years , @ male and @ female ) were randomised to the control or intervention group .", "both groups received weekly sessions with a physiotherapist for @weeks or until the time of medical clearance .", "both groups received postural education , range of motion exercises and cognitive and physical rest until asymptomatic followed by a protocol of graded exertion .", "the intervention group also received cervical spine and vestibular rehabilitation .", "the primary outcome of interest was medical clearance to return to sport , which was evaluated by a study sport medicine physician who was blinded to the treatment group .", "in the treatment group , @ % ( @/@ ) of the participants were medically cleared within @weeks of initiation of treatment , compared with @ % ( @/@ ) in the control group .", "using an intention to treat analysis , individuals in the treatment group were @ ( @ % ci @ to @ ) times more likely to be medically cleared by @weeks .", "a combination of cervical and vestibular physiotherapy decreased time to medical clearance to return to sport in youth and young adults with persistent symptoms of dizziness , neck pain and/or headaches following a sport-related concussion .", "nct@ ." ]
concussion is a common injury in sport . most individuals recover in @-@days but some have persistent symptoms . the objective of this study was to determine if a combination of vestibular rehabilitation and cervical spine physiotherapy decreased the time until medical clearance in individuals with prolonged postconcussion symptoms . this study was a randomised controlled trial . consecutive patients with persistent symptoms of dizziness , neck pain and/or headaches following a sport-related concussion ( @-@years , @ male and @ female ) were randomised to the control or intervention group . both groups received weekly sessions with a physiotherapist for @weeks or until the time of medical clearance . both groups received postural education , range of motion exercises and cognitive and physical rest until asymptomatic followed by a protocol of graded exertion . the intervention group also received cervical spine and vestibular rehabilitation . the primary outcome of interest was medical clearance to return to sport , which was evaluated by a study sport medicine physician who was blinded to the treatment group . in the treatment group , @ % ( @/@ ) of the participants were medically cleared within @weeks of initiation of treatment , compared with @ % ( @/@ ) in the control group . using an intention to treat analysis , individuals in the treatment group were @ ( @ % ci @ to @ ) times more likely to be medically cleared by @weeks . a combination of cervical and vestibular physiotherapy decreased time to medical clearance to return to sport in youth and young adults with persistent symptoms of dizziness , neck pain and/or headaches following a sport-related concussion . nct@ .
24,855,132
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]
[ "mini percutaneous nephrolithotomy ( mini-pcnl ) and retrograde intrarenal surgery ( rirs ) are well-established techniques with little morbidity .", "the combined use of standard pcnl and the mini-pcnl or the rirs technique was evaluated and compared to investigate their own role in the management of staghorn calculi in solitary kidney .", "@ patients received combined standard pcnl and mini-pcnl ( group @ ) , and @ patients received combined standard pcnl and rirs ( group @ ) .", "the treatment results and complications were evaluated and compared .", "the mean operation time was @ @ min in group @ and @ @ min in group @ ( p < @ ) .", "the decrease in hemoglobin level in group @ was significantly higher than that in group @ ( @ @ vs. @ @ g/dl , p < @ ) .", "the final stone-free rate was significantly higher ( p = @ ) in group @ ( @ % ) than in group @ ( @ % ) .", "combined standard pcnl and rirs technique can extract the majority of staghorn calculi quickly by pcnl with ems lithoclast , and rirs used simultaneously can reduce the need for multiple tracts and therefore reduce blood loss and potential morbidity related to multiple tracts , shorten the operation time and achieve a high stone-free rate ." ]
mini percutaneous nephrolithotomy ( mini-pcnl ) and retrograde intrarenal surgery ( rirs ) are well-established techniques with little morbidity . the combined use of standard pcnl and the mini-pcnl or the rirs technique was evaluated and compared to investigate their own role in the management of staghorn calculi in solitary kidney . @ patients received combined standard pcnl and mini-pcnl ( group @ ) , and @ patients received combined standard pcnl and rirs ( group @ ) . the treatment results and complications were evaluated and compared . the mean operation time was @ @ min in group @ and @ @ min in group @ ( p < @ ) . the decrease in hemoglobin level in group @ was significantly higher than that in group @ ( @ @ vs. @ @ g/dl , p < @ ) . the final stone-free rate was significantly higher ( p = @ ) in group @ ( @ % ) than in group @ ( @ % ) . combined standard pcnl and rirs technique can extract the majority of staghorn calculi quickly by pcnl with ems lithoclast , and rirs used simultaneously can reduce the need for multiple tracts and therefore reduce blood loss and potential morbidity related to multiple tracts , shorten the operation time and achieve a high stone-free rate .
25,034,200
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "hyperhidrosis is a chronic disease characterized by increased sweat production .", "local injections of botulinum toxin a ( btx-a ) have been extensively used for treatment of primary hyperhidrosis ( idiopathic ) .", "the current treatment for this condition involves several intradermal injections , resulting in poor patient compliance due to injection-related pain .", "therefore , new protocols , including an improved anesthetic regimen , are required .", "we designed the present study to determine whether jetpeel-@ , a medical device used for transdermal delivery of drugs by jet nebulization , could be used to deliver lidocaine prior to the standard multiple btx-a injections or deliver lidocaine together with btx-a in order to determine the protocol giving better results in terms of procedure-related pain , sweating , and patient satisfaction in subjects affected by primary axillary , palmar or plantar hyperhidrosis .", "twenty patients with a visual analog scale ( vas ) sweating score @ cm were randomized to receive lidocaine @ % ( @ ml ) delivered by jetpeel-@ followed by multiple injections of btx-a ( @ units ) or lidocaine @ % ( @ ml ) and btx-a ( @ units ) delivered together by jetpeel-@ .", "effect of treatment on sweating was measured by vas ( @ = minimum sweating ; @ = maximum sweating ) at @-month follow-up .", "pain induced by the procedure was assessed by vas ( @ = minimum pain ; @ = maximum pain ) immediately after the procedure .", "patient satisfaction was assessed at @-month follow-up using a @-point scale ( @ = not at all satisfied ; @ = not satisfied ; @ = partially satisfied ; @ = satisfied ; @ = highly satisfied ) .", "both treatment modalities reduced sweating at @-month follow-up , if compared with baseline ( all p < @ ) .", "delivery of lidocaine and btx-a by jetpeel-@ resulted in lower procedure-related pain and reduced sweating , if compared with lidocaine delivered by jetpeel-@ followed by multiple btx-a injections ( all p < @ ) .", "patient satisfaction with the procedure was higher in the group receiving lidocaine and btx-a treatment by jetpeel-@ , if compared with lidocaine delivered by jetpeel-@ followed by multiple btx-a injections ( p < @ ) .", "no side effects were observed in both groups .", "lidocaine and btx-a can be safely delivered together by jetpeel-@ to treat primary palmar , plantar and axillary hyperhidrosis , resulting in lower procedure-related pain , improved sweating and higher patient satisfaction , if compared with lidocaine delivered by jetpeel-@ followed by standard btx-a injection therapy .", "our protocol delivering lidocaine and btx-a together by jetpeel-@ requires a reduced quantity of btx-a , further supporting the use of the transdermal drug delivery by jet nebulization over standard injection therapy for treatment of primary hyperhidrosis ." ]
hyperhidrosis is a chronic disease characterized by increased sweat production . local injections of botulinum toxin a ( btx-a ) have been extensively used for treatment of primary hyperhidrosis ( idiopathic ) . the current treatment for this condition involves several intradermal injections , resulting in poor patient compliance due to injection-related pain . therefore , new protocols , including an improved anesthetic regimen , are required . we designed the present study to determine whether jetpeel-@ , a medical device used for transdermal delivery of drugs by jet nebulization , could be used to deliver lidocaine prior to the standard multiple btx-a injections or deliver lidocaine together with btx-a in order to determine the protocol giving better results in terms of procedure-related pain , sweating , and patient satisfaction in subjects affected by primary axillary , palmar or plantar hyperhidrosis . twenty patients with a visual analog scale ( vas ) sweating score @ cm were randomized to receive lidocaine @ % ( @ ml ) delivered by jetpeel-@ followed by multiple injections of btx-a ( @ units ) or lidocaine @ % ( @ ml ) and btx-a ( @ units ) delivered together by jetpeel-@ . effect of treatment on sweating was measured by vas ( @ = minimum sweating ; @ = maximum sweating ) at @-month follow-up . pain induced by the procedure was assessed by vas ( @ = minimum pain ; @ = maximum pain ) immediately after the procedure . patient satisfaction was assessed at @-month follow-up using a @-point scale ( @ = not at all satisfied ; @ = not satisfied ; @ = partially satisfied ; @ = satisfied ; @ = highly satisfied ) . both treatment modalities reduced sweating at @-month follow-up , if compared with baseline ( all p < @ ) . delivery of lidocaine and btx-a by jetpeel-@ resulted in lower procedure-related pain and reduced sweating , if compared with lidocaine delivered by jetpeel-@ followed by multiple btx-a injections ( all p < @ ) . patient satisfaction with the procedure was higher in the group receiving lidocaine and btx-a treatment by jetpeel-@ , if compared with lidocaine delivered by jetpeel-@ followed by multiple btx-a injections ( p < @ ) . no side effects were observed in both groups . lidocaine and btx-a can be safely delivered together by jetpeel-@ to treat primary palmar , plantar and axillary hyperhidrosis , resulting in lower procedure-related pain , improved sweating and higher patient satisfaction , if compared with lidocaine delivered by jetpeel-@ followed by standard btx-a injection therapy . our protocol delivering lidocaine and btx-a together by jetpeel-@ requires a reduced quantity of btx-a , further supporting the use of the transdermal drug delivery by jet nebulization over standard injection therapy for treatment of primary hyperhidrosis .
25,075,176
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "there is increasing emphasis on the importance of intraocular pressure peaks and fluctuations as risk factors for glaucoma progression .", "it is well recognized that the water drinking test raises intraocular pressure and there is reasonable evidence that caffeine can also raise intraocular pressure .", "the aim of this study is to directly compare the effect of a caffeine test to that of the water drinking test on intraocular pressure , in patients with glaucoma .", "prospective , observer-masked , cross-over study .", "fourteen eyes of @ patients with primary open-angle glaucoma .", "patients were initially randomized to either caffeine test or water drinking test .", "intraocular pressure was measured in both eyes with a goldmann applanation tonometer at baseline and every @min for @h , by a masked examiner .", "this was repeated the following week at the same time of day for the other test ( the cross-over ) .", "peak intraocular pressure and maximum fluctuation from baseline were compared between groups using paired t-tests .", "peak and fluctuation of intraocular pressure , time of maximum frequency of peak intraocular pressure .", "the maximum intraocular pressure from the water drinking test ( @ ) was greater than the caffeine test ( @ ) and showed greater fluctuation in intraocular pressure ( @ mmhg -lsb- @ % -rsb- ; p < @ ) compared with the caffeine test ( @ mmhg -lsb- @ % -rsb- ) ; p = @ ) .", "the rise in intraocular pressure was greater with water drinking test than the caffeine test .", "caffeine does not appear to provide an alternative for patients unable to tolerate the water drinking test ." ]
there is increasing emphasis on the importance of intraocular pressure peaks and fluctuations as risk factors for glaucoma progression . it is well recognized that the water drinking test raises intraocular pressure and there is reasonable evidence that caffeine can also raise intraocular pressure . the aim of this study is to directly compare the effect of a caffeine test to that of the water drinking test on intraocular pressure , in patients with glaucoma . prospective , observer-masked , cross-over study . fourteen eyes of @ patients with primary open-angle glaucoma . patients were initially randomized to either caffeine test or water drinking test . intraocular pressure was measured in both eyes with a goldmann applanation tonometer at baseline and every @min for @h , by a masked examiner . this was repeated the following week at the same time of day for the other test ( the cross-over ) . peak intraocular pressure and maximum fluctuation from baseline were compared between groups using paired t-tests . peak and fluctuation of intraocular pressure , time of maximum frequency of peak intraocular pressure . the maximum intraocular pressure from the water drinking test ( @ ) was greater than the caffeine test ( @ ) and showed greater fluctuation in intraocular pressure ( @ mmhg -lsb- @ % -rsb- ; p < @ ) compared with the caffeine test ( @ mmhg -lsb- @ % -rsb- ) ; p = @ ) . the rise in intraocular pressure was greater with water drinking test than the caffeine test . caffeine does not appear to provide an alternative for patients unable to tolerate the water drinking test .
24,304,594
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "patients with knee and/or hip osteoarthritis ( oa ) are less physically active than the general population , while the benefits of physical activity ( pa ) have been well documented .", "based on the behavioral graded activity treatment , we developed a web-based intervention to improve pa levels in patients with knee and/or hip oa , entitled `` join@move '' .", "the join@move intervention is a self-paced @-week pa program in which the patient 's favorite recreational activity is gradually increased in a time-contingent way .", "the aim of the study was to investigate whether a fully automated web-based pa intervention in patients with knee and/or hip oa would result in improved levels of pa , physical function , and self-perceived effect compared with a waiting list control group .", "the study design was a two-armed randomized controlled trial which was not blinded .", "volunteers were recruited via articles in newspapers and health-related websites .", "eligibility criteria for participants were : ( @ ) aged @-@ years , ( @ ) self-reported knee and/or hip oa , ( @ ) self-reported inactivity ( @ minutes of moderate pa , @ times or less per week ) , ( @ ) no face-to-face consultation with a health care provider other than general practitioners , for oa in the last @ months , ( @ ) ability to access the internet weekly , and ( @ ) no contra-indications to exercise without supervision .", "baseline , @-month , and @-month follow-up data were collected through online questionnaires .", "primary outcomes were pa , physical function , and self-perceived effect .", "in a subgroup of participants , pa was measured objectively using accelerometers .", "secondary outcomes were pain , fatigue , anxiety , depression , symptoms , quality of life , self-efficacy , pain coping , and locus of control .", "of the @ interested respondents , @ eligible participants were randomly assigned to the intervention ( n = @ ) or waiting list control group ( n = @ ) .", "response rates of questionnaires were @ % ( @/@ ) after @ months and @ % ( @/@ ) after @ months .", "in this study , @ % ( @/@ ) of participants actually started the program , and @ % ( @/@ ) reached the adherence threshold of @ out of @ modules completed .", "at @ months , participants in the intervention group reported a significantly improved physical function status ( difference = @ points , @ % ci @-@ @ ) and a positive self-perceived effect ( or @ , @ % ci @-@ @ ) compared with the control group .", "no effect was found for self-reported pa. .", "after @ months , the intervention group showed higher levels of subjective ( difference = @ points , @ % ci @-@ @ ) and objective pa ( difference = @ minutes , @ % ci @-@ @ ) compared with the control group .", "after @ months , no effect was found for physical function ( difference = @ points , @ % ci -@ to @ ) and self-perceived effect ( or @ , @ % ci @-@ @ ) .", "for several secondary endpoints , the intervention group demonstrated improvements in favor of the intervention group .", "join@move resulted in changes in the desired direction for several primary and secondary outcomes .", "given the benefits and its self-help format , join@move could be a component in the effort to enhance pa in sedentary patients with knee and/or hip oa ." ]
patients with knee and/or hip osteoarthritis ( oa ) are less physically active than the general population , while the benefits of physical activity ( pa ) have been well documented . based on the behavioral graded activity treatment , we developed a web-based intervention to improve pa levels in patients with knee and/or hip oa , entitled `` join@move '' . the join@move intervention is a self-paced @-week pa program in which the patient 's favorite recreational activity is gradually increased in a time-contingent way . the aim of the study was to investigate whether a fully automated web-based pa intervention in patients with knee and/or hip oa would result in improved levels of pa , physical function , and self-perceived effect compared with a waiting list control group . the study design was a two-armed randomized controlled trial which was not blinded . volunteers were recruited via articles in newspapers and health-related websites . eligibility criteria for participants were : ( @ ) aged @-@ years , ( @ ) self-reported knee and/or hip oa , ( @ ) self-reported inactivity ( @ minutes of moderate pa , @ times or less per week ) , ( @ ) no face-to-face consultation with a health care provider other than general practitioners , for oa in the last @ months , ( @ ) ability to access the internet weekly , and ( @ ) no contra-indications to exercise without supervision . baseline , @-month , and @-month follow-up data were collected through online questionnaires . primary outcomes were pa , physical function , and self-perceived effect . in a subgroup of participants , pa was measured objectively using accelerometers . secondary outcomes were pain , fatigue , anxiety , depression , symptoms , quality of life , self-efficacy , pain coping , and locus of control . of the @ interested respondents , @ eligible participants were randomly assigned to the intervention ( n = @ ) or waiting list control group ( n = @ ) . response rates of questionnaires were @ % ( @/@ ) after @ months and @ % ( @/@ ) after @ months . in this study , @ % ( @/@ ) of participants actually started the program , and @ % ( @/@ ) reached the adherence threshold of @ out of @ modules completed . at @ months , participants in the intervention group reported a significantly improved physical function status ( difference = @ points , @ % ci @-@ @ ) and a positive self-perceived effect ( or @ , @ % ci @-@ @ ) compared with the control group . no effect was found for self-reported pa. . after @ months , the intervention group showed higher levels of subjective ( difference = @ points , @ % ci @-@ @ ) and objective pa ( difference = @ minutes , @ % ci @-@ @ ) compared with the control group . after @ months , no effect was found for physical function ( difference = @ points , @ % ci -@ to @ ) and self-perceived effect ( or @ , @ % ci @-@ @ ) . for several secondary endpoints , the intervention group demonstrated improvements in favor of the intervention group . join@move resulted in changes in the desired direction for several primary and secondary outcomes . given the benefits and its self-help format , join@move could be a component in the effort to enhance pa in sedentary patients with knee and/or hip oa .
24,269,911
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the pathophysiological role of iron in parkinson 's disease ( pd ) was assessed by a chelation strategy aimed at reducing oxidative damage associated with regional iron deposition without affecting circulating metals .", "translational cell and animal models provided concept proofs and a delayed-start ( ds ) treatment paradigm , the basis for preliminary clinical assessments .", "for translational studies , we assessed the effect of oxidative insults in mice systemically prechelated with deferiprone ( dfp ) by following motor functions , striatal dopamine ( hplc and mri-pet ) , and brain iron deposition ( relaxation-r@ * - mri ) aided by spectroscopic measurements of neuronal labile iron ( with fluorescence-sensitive iron sensors ) and oxidative damage by markers of protein , lipid , and dna modification .", "dfp significantly reduced labile iron and biological damage in oxidation-stressed cells and animals , improving motor functions while raising striatal dopamine .", "for a pilot , double-blind , placebo-controlled randomized clinical trial , early-stage parkinson 's patients on stabilized dopamine regimens enrolled in a @-month single-center study with dfp ( @ mg/kg/day ) .", "based on a @-month ds paradigm , early-start patients ( n = @ ) compared to ds patients ( n = @ ) ( @/@ completed ) responded significantly earlier and sustainably to treatment in both substantia nigra iron deposits ( r@ * mri ) and unified parkinson 's disease rating scale motor indicators of disease progression ( p < @ and p < @ , respectively ) .", "apart from three rapidly resolved neutropenia cases , safety was maintained throughout the trial .", "a moderate iron chelation regimen that avoids changes in systemic iron levels may constitute a novel therapeutic modality for pd .", "the therapeutic features of a chelation modality established in translational models and in pilot clinical trials warrant comprehensive evaluation of symptomatic and/or disease-modifying potential of chelation in pd ." ]
the pathophysiological role of iron in parkinson 's disease ( pd ) was assessed by a chelation strategy aimed at reducing oxidative damage associated with regional iron deposition without affecting circulating metals . translational cell and animal models provided concept proofs and a delayed-start ( ds ) treatment paradigm , the basis for preliminary clinical assessments . for translational studies , we assessed the effect of oxidative insults in mice systemically prechelated with deferiprone ( dfp ) by following motor functions , striatal dopamine ( hplc and mri-pet ) , and brain iron deposition ( relaxation-r@ * - mri ) aided by spectroscopic measurements of neuronal labile iron ( with fluorescence-sensitive iron sensors ) and oxidative damage by markers of protein , lipid , and dna modification . dfp significantly reduced labile iron and biological damage in oxidation-stressed cells and animals , improving motor functions while raising striatal dopamine . for a pilot , double-blind , placebo-controlled randomized clinical trial , early-stage parkinson 's patients on stabilized dopamine regimens enrolled in a @-month single-center study with dfp ( @ mg/kg/day ) . based on a @-month ds paradigm , early-start patients ( n = @ ) compared to ds patients ( n = @ ) ( @/@ completed ) responded significantly earlier and sustainably to treatment in both substantia nigra iron deposits ( r@ * mri ) and unified parkinson 's disease rating scale motor indicators of disease progression ( p < @ and p < @ , respectively ) . apart from three rapidly resolved neutropenia cases , safety was maintained throughout the trial . a moderate iron chelation regimen that avoids changes in systemic iron levels may constitute a novel therapeutic modality for pd . the therapeutic features of a chelation modality established in translational models and in pilot clinical trials warrant comprehensive evaluation of symptomatic and/or disease-modifying potential of chelation in pd .
24,251,381
[ "OBJECTIVE", "OBJECTIVE", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "METHODS", "CONCLUSIONS" ]
[ "to compare the efficacy and toxicity of the chemotherapeutic regimen containing pirarubicin and mitoxantrone on the treatment of relapsed or refractory acute myeloid leukemia ( aml ) in adults .", "in this open prospective multicentre study , we randomly assigned patients with relapsed or refractory aml to receive tae regimen ( pirarubicin + cytarabine + etoposide ) versus mae regimen ( mitoxantrone + cytarabine + etoposide ) .", "the efficacy and toxicity were compared between the two groups .", "@ patients entered this clinical trial .", "the complete remission ( cr ) rate on tae arm was @ % versus @ % on mae arm with the overall response ( or ) rates of @ % versus @ % , respectively .", "the cr was higher on tae arm ( p = @ ) but with no significant difference between the two groups regarding the overall response ( or ) rate .", "the regimens were well tolerated in both groups .", "hematologic and non-hematologic toxicity were similar except relatively lower the mean dosage of g-csf , red blood cells and platelets transfusion on tae arm .", "no significant differences were seen between the two groups regarding the overall survival and relapse free survival rates .", "tae regimen might be an effective salvage therapy in patients with relapsed or refractory aml ." ]
to compare the efficacy and toxicity of the chemotherapeutic regimen containing pirarubicin and mitoxantrone on the treatment of relapsed or refractory acute myeloid leukemia ( aml ) in adults . in this open prospective multicentre study , we randomly assigned patients with relapsed or refractory aml to receive tae regimen ( pirarubicin + cytarabine + etoposide ) versus mae regimen ( mitoxantrone + cytarabine + etoposide ) . the efficacy and toxicity were compared between the two groups . @ patients entered this clinical trial . the complete remission ( cr ) rate on tae arm was @ % versus @ % on mae arm with the overall response ( or ) rates of @ % versus @ % , respectively . the cr was higher on tae arm ( p = @ ) but with no significant difference between the two groups regarding the overall response ( or ) rate . the regimens were well tolerated in both groups . hematologic and non-hematologic toxicity were similar except relatively lower the mean dosage of g-csf , red blood cells and platelets transfusion on tae arm . no significant differences were seen between the two groups regarding the overall survival and relapse free survival rates . tae regimen might be an effective salvage therapy in patients with relapsed or refractory aml .
24,857,206
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "tuberculous pericarditis is associated with high morbidity and mortality even if antituberculosis therapy is administered .", "we evaluated the effects of adjunctive glucocorticoid therapy and mycobacterium indicus pranii immunotherapy in patients with tuberculous pericarditis .", "using a @-by-@ factorial design , we randomly assigned @ adults with definite or probable tuberculous pericarditis to either prednisolone or placebo for @ weeks and to either m. indicus pranii or placebo , administered in five injections over the course of @ months .", "two thirds of the participants had concomitant human immunodeficiency virus ( hiv ) infection .", "the primary efficacy outcome was a composite of death , cardiac tamponade requiring pericardiocentesis , or constrictive pericarditis .", "there was no significant difference in the primary outcome between patients who received prednisolone and those who received placebo ( @ % and @ % , respectively ; hazard ratio , @ ; @ % confidence interval -lsb- ci -rsb- , @ to @ ; p = @ ) or between those who received m. indicus pranii immunotherapy and those who received placebo ( @ % and @ % , respectively ; hazard ratio , @ ; @ % ci , @ to @ ; p = @ ) .", "prednisolone therapy , as compared with placebo , was associated with significant reductions in the incidence of constrictive pericarditis ( @ % vs. @ % ; hazard ratio , @ ; @ % ci , @ to @ ; p = @ ) and hospitalization ( @ % vs. @ % ; hazard ratio , @ ; @ % ci , @ to @ ; p = @ ) .", "both prednisolone and m. indicus pranii , each as compared with placebo , were associated with a significant increase in the incidence of cancer ( @ % vs. @ % ; hazard ratio , @ ; @ % ci , @ to @ ; p = @ , and @ % vs. @ % ; hazard ratio , @ ; @ % ci , @ to @ ; p = @ , respectively ) , owing mainly to an increase in hiv-associated cancer .", "in patients with tuberculous pericarditis , neither prednisolone nor m. indicus pranii had a significant effect on the composite of death , cardiac tamponade requiring pericardiocentesis , or constrictive pericarditis .", "( funded by the canadian institutes of health research and others ; impi clinicaltrials.gov number , nct@ . )" ]
tuberculous pericarditis is associated with high morbidity and mortality even if antituberculosis therapy is administered . we evaluated the effects of adjunctive glucocorticoid therapy and mycobacterium indicus pranii immunotherapy in patients with tuberculous pericarditis . using a @-by-@ factorial design , we randomly assigned @ adults with definite or probable tuberculous pericarditis to either prednisolone or placebo for @ weeks and to either m. indicus pranii or placebo , administered in five injections over the course of @ months . two thirds of the participants had concomitant human immunodeficiency virus ( hiv ) infection . the primary efficacy outcome was a composite of death , cardiac tamponade requiring pericardiocentesis , or constrictive pericarditis . there was no significant difference in the primary outcome between patients who received prednisolone and those who received placebo ( @ % and @ % , respectively ; hazard ratio , @ ; @ % confidence interval -lsb- ci -rsb- , @ to @ ; p = @ ) or between those who received m. indicus pranii immunotherapy and those who received placebo ( @ % and @ % , respectively ; hazard ratio , @ ; @ % ci , @ to @ ; p = @ ) . prednisolone therapy , as compared with placebo , was associated with significant reductions in the incidence of constrictive pericarditis ( @ % vs. @ % ; hazard ratio , @ ; @ % ci , @ to @ ; p = @ ) and hospitalization ( @ % vs. @ % ; hazard ratio , @ ; @ % ci , @ to @ ; p = @ ) . both prednisolone and m. indicus pranii , each as compared with placebo , were associated with a significant increase in the incidence of cancer ( @ % vs. @ % ; hazard ratio , @ ; @ % ci , @ to @ ; p = @ , and @ % vs. @ % ; hazard ratio , @ ; @ % ci , @ to @ ; p = @ , respectively ) , owing mainly to an increase in hiv-associated cancer . in patients with tuberculous pericarditis , neither prednisolone nor m. indicus pranii had a significant effect on the composite of death , cardiac tamponade requiring pericardiocentesis , or constrictive pericarditis . ( funded by the canadian institutes of health research and others ; impi clinicaltrials.gov number , nct@ . )
25,178,809
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "osteoporosis and cardiovascular disease may share common biological pathways , with inflammation playing a role in the development of both .", "although observational studies have suggested that statin use is associated with a lower risk of fractures , randomized trial data addressing this issue are scant .", "to determine whether statin therapy reduces the risk of fracture and , in a secondary analysis , whether baseline levels of the inflammatory biomarker high-sensitivity c-reactive protein ( hs-crp ) are associated with the risk of fracture .", "the jupiter ( justification for the use of statins in prevention : an intervention trial evaluating rosuvastatin ) trial was an international , randomized , double-blind , placebo-controlled study enrolling @,@ men older than @ years and women older than @ years with hs-crp level of at least @ mg/l .", "participants were screened from @ to @ and observed prospectively for up to @ years ( median follow-up , @ years ) .", "rosuvastatin calcium , @ mg daily , or placebo .", "incident fracture was a prespecified secondary end point of jupiter .", "fractures were confirmed by radiographs , computed tomography , bone scan , or other methods .", "cox proportional hazards models were used to calculate hazard ratios ( hrs ) and associated @ % confidence intervals for the risk of fracture according to randomized treatment assignment , as well as increasing tertiles of hs-crp , controlling for potential confounders .", "during the study , @ incident fractures were reported and confirmed .", "among participants allocated to rosuvastatin , @ fractures were confirmed , compared with @ among those allocated to placebo , such that the incidence of fracture in the rosuvastatin and placebo groups was @ and @ per @ person-years , respectively ( adjusted hr , @ -lsb- @ % ci , @-@ @ -rsb- ; p = @ ) .", "overall , increasing baseline hs-crp level was not associated with an increased risk of fractures ( adjusted hr for each unit increase in hs-crp tertile , @ -lsb- @ % ci , @-@ @ -rsb- ; p for trend , @ ) .", "among men and women with elevated hs-crp level enrolled in a large trial of rosuvastatin therapy for cardiovascular disease , statin therapy did not reduce the risk of fracture .", "higher baseline hs-crp level was not associated with an increased risk of incident fracture .", "clinicaltrials.gov identifier : nct@ ." ]
osteoporosis and cardiovascular disease may share common biological pathways , with inflammation playing a role in the development of both . although observational studies have suggested that statin use is associated with a lower risk of fractures , randomized trial data addressing this issue are scant . to determine whether statin therapy reduces the risk of fracture and , in a secondary analysis , whether baseline levels of the inflammatory biomarker high-sensitivity c-reactive protein ( hs-crp ) are associated with the risk of fracture . the jupiter ( justification for the use of statins in prevention : an intervention trial evaluating rosuvastatin ) trial was an international , randomized , double-blind , placebo-controlled study enrolling @,@ men older than @ years and women older than @ years with hs-crp level of at least @ mg/l . participants were screened from @ to @ and observed prospectively for up to @ years ( median follow-up , @ years ) . rosuvastatin calcium , @ mg daily , or placebo . incident fracture was a prespecified secondary end point of jupiter . fractures were confirmed by radiographs , computed tomography , bone scan , or other methods . cox proportional hazards models were used to calculate hazard ratios ( hrs ) and associated @ % confidence intervals for the risk of fracture according to randomized treatment assignment , as well as increasing tertiles of hs-crp , controlling for potential confounders . during the study , @ incident fractures were reported and confirmed . among participants allocated to rosuvastatin , @ fractures were confirmed , compared with @ among those allocated to placebo , such that the incidence of fracture in the rosuvastatin and placebo groups was @ and @ per @ person-years , respectively ( adjusted hr , @ -lsb- @ % ci , @-@ @ -rsb- ; p = @ ) . overall , increasing baseline hs-crp level was not associated with an increased risk of fractures ( adjusted hr for each unit increase in hs-crp tertile , @ -lsb- @ % ci , @-@ @ -rsb- ; p for trend , @ ) . among men and women with elevated hs-crp level enrolled in a large trial of rosuvastatin therapy for cardiovascular disease , statin therapy did not reduce the risk of fracture . higher baseline hs-crp level was not associated with an increased risk of incident fracture . clinicaltrials.gov identifier : nct@ .
25,437,881
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "primary data about rates of formal diagnosis of dementia in the german primary care sector are widely lacking .", "main objectives are to analyze the rate of syndrome diagnosis in primary care patients who screened positive for dementia , the distribution of differential diagnoses , and factors associated with undiagnosed dementia .", "delphi-mv ( dementia : life - and person-centered help in mecklenburg-western pomerania ) is an ongoing general practitioner ( gp ) - based , randomized , controlled intervention trial .", "a total of @,@ patients ( @ years , living at home ) recruited from @ participating gp practices were screened for dementia ( demtect < @ ) .", "of @ eligible patients ( @ % ) , a total of @ subjects ( @ % ) provided informed consent .", "present analyses are based on the data of @ patients with complete baseline assessment on january @ , @ ( preliminary data ) .", "formal diagnoses were retrieved from the medical records of the treating gps .", "a conditional fixed effect regression analysis was performed to analyze factors associated with undiagnosed dementia .", "a total of @ % of patients who screened positive for dementia had been formally diagnosed with dementia .", "unspecified dementia was diagnosed in @ % , vascular dementia in @ % , and alzheimer 's disease in @ % of these patients .", "undiagnosed dementia was significantly associated with a higher mean score in the mini-mental state examination ( odds ratio , @ ; p < @ , @ % confidence interval @-@ @ ) .", "the diagnosis rate of dementia in german primary care ( @ % ) is well within the range of the international data ( @-@ % ) .", "the results emphasize the need for action to enhance recognition and differential diagnosis of dementia ." ]
primary data about rates of formal diagnosis of dementia in the german primary care sector are widely lacking . main objectives are to analyze the rate of syndrome diagnosis in primary care patients who screened positive for dementia , the distribution of differential diagnoses , and factors associated with undiagnosed dementia . delphi-mv ( dementia : life - and person-centered help in mecklenburg-western pomerania ) is an ongoing general practitioner ( gp ) - based , randomized , controlled intervention trial . a total of @,@ patients ( @ years , living at home ) recruited from @ participating gp practices were screened for dementia ( demtect < @ ) . of @ eligible patients ( @ % ) , a total of @ subjects ( @ % ) provided informed consent . present analyses are based on the data of @ patients with complete baseline assessment on january @ , @ ( preliminary data ) . formal diagnoses were retrieved from the medical records of the treating gps . a conditional fixed effect regression analysis was performed to analyze factors associated with undiagnosed dementia . a total of @ % of patients who screened positive for dementia had been formally diagnosed with dementia . unspecified dementia was diagnosed in @ % , vascular dementia in @ % , and alzheimer 's disease in @ % of these patients . undiagnosed dementia was significantly associated with a higher mean score in the mini-mental state examination ( odds ratio , @ ; p < @ , @ % confidence interval @-@ @ ) . the diagnosis rate of dementia in german primary care ( @ % ) is well within the range of the international data ( @-@ % ) . the results emphasize the need for action to enhance recognition and differential diagnosis of dementia .
24,898,640
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the aim was to test a new protocol of luteal phase administration of clomiphene citrate ( cc ) for ovulation induction in women with polycystic ovary syndrome ( pcos ) .", "this was a prospective , randomized , controlled trial .", "two hundred and fifty-two women ( cycles ) with pcos were utilized to create two groups .", "patients in group @ ( @ patients ) received @mg of cc daily for @days starting on day @ of menses , and patients in group @ ( @ patients ) received @mg of cc daily for @days starting the next day after finishing medroxyprogesterone acetate ( mpa ) ( before withdrawal bleeding ) .", "the main outcome measures were the number of growing and mature follicles , serum e@ ( in pg/ml ) , serum progesterone ( in ng/ml ) levels , endometrial thickness ( in mm ) , pregnancy , and miscarriage rates .", "the total number of follicles and the number of follicles @mm during stimulation were significantly greater in group @ .", "the endometrial thickness at the time of human chorionic gonadotrophin ( hcg ) administration was significantly greater in group @ as compared to group @ ( @ and @ , respectively ) .", "serum e@ levels were also significantly higher ( p < @ ) in group @ as compared to group @ ( @ vs. @ pg/ml ) .", "pregnancy occurred in @ patients ( @ % ) in group @ and in @ patients ( @ % ) in group @ .", "the difference was not statistically significant .", "luteal phase administration of cc in patients with pcos leads to increased follicular growth and endometrial thickness , which might result in a higher pregnancy rate ." ]
the aim was to test a new protocol of luteal phase administration of clomiphene citrate ( cc ) for ovulation induction in women with polycystic ovary syndrome ( pcos ) . this was a prospective , randomized , controlled trial . two hundred and fifty-two women ( cycles ) with pcos were utilized to create two groups . patients in group @ ( @ patients ) received @mg of cc daily for @days starting on day @ of menses , and patients in group @ ( @ patients ) received @mg of cc daily for @days starting the next day after finishing medroxyprogesterone acetate ( mpa ) ( before withdrawal bleeding ) . the main outcome measures were the number of growing and mature follicles , serum e@ ( in pg/ml ) , serum progesterone ( in ng/ml ) levels , endometrial thickness ( in mm ) , pregnancy , and miscarriage rates . the total number of follicles and the number of follicles @mm during stimulation were significantly greater in group @ . the endometrial thickness at the time of human chorionic gonadotrophin ( hcg ) administration was significantly greater in group @ as compared to group @ ( @ and @ , respectively ) . serum e@ levels were also significantly higher ( p < @ ) in group @ as compared to group @ ( @ vs. @ pg/ml ) . pregnancy occurred in @ patients ( @ % ) in group @ and in @ patients ( @ % ) in group @ . the difference was not statistically significant . luteal phase administration of cc in patients with pcos leads to increased follicular growth and endometrial thickness , which might result in a higher pregnancy rate .
24,840,109
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the risks associated with gestational diabetes mellitus ( gdm ) are well recognized , and there is increasing evidence to support treatment of the condition .", "however , clear guidance on the ideal approach to screening for gdm is lacking .", "professional groups continue to debate whether selective screening ( based on risk factors ) or universal screening is the most appropriate approach .", "additionally , there is ongoing debate about what levels of glucose abnormalities during pregnancy respond best to treatment and which maternal and neonatal outcomes benefit most from treatment .", "furthermore , the implications of possible screening options on health care costs are not well established .", "in response to this uncertainty there have been repeated calls for well-designed , randomised trials to determine the efficacy of screening , diagnosis , and management plans for gdm .", "we describe a randomised controlled trial to investigate screening uptake rates and the clinical and cost effectiveness of screening in primary versus secondary care settings .", "this will be an unblinded , two-group , parallel randomised controlled trial ( rct ) .", "the target population includes @ women presenting for their first antenatal visit at @ to @ weeks gestation at two hospitals in the west of ireland : galway university hospital and mayo general hospital .", "participants will be offered universal screening for gdm at @ to @ weeks gestation in either primary care ( n = @ ) or secondary care ( n = @ ) locations .", "the primary outcome variable is the uptake rate of screening .", "secondary outcomes include indicators of clinical effectiveness of screening at each screening site ( primary and secondary ) including gestational week at time of screening , time to access antenatal diabetes services for women diagnosed with gdm , and pregnancy and neonatal outcomes for women with gdm .", "in addition , parallel economic and qualitative evaluations will be conducted .", "the trial will cover the period from the woman 's first hospital antenatal visit at @ to @ weeks gestation , until the completion of the pregnancy .", "current controlled trials : isrctn@ ." ]
the risks associated with gestational diabetes mellitus ( gdm ) are well recognized , and there is increasing evidence to support treatment of the condition . however , clear guidance on the ideal approach to screening for gdm is lacking . professional groups continue to debate whether selective screening ( based on risk factors ) or universal screening is the most appropriate approach . additionally , there is ongoing debate about what levels of glucose abnormalities during pregnancy respond best to treatment and which maternal and neonatal outcomes benefit most from treatment . furthermore , the implications of possible screening options on health care costs are not well established . in response to this uncertainty there have been repeated calls for well-designed , randomised trials to determine the efficacy of screening , diagnosis , and management plans for gdm . we describe a randomised controlled trial to investigate screening uptake rates and the clinical and cost effectiveness of screening in primary versus secondary care settings . this will be an unblinded , two-group , parallel randomised controlled trial ( rct ) . the target population includes @ women presenting for their first antenatal visit at @ to @ weeks gestation at two hospitals in the west of ireland : galway university hospital and mayo general hospital . participants will be offered universal screening for gdm at @ to @ weeks gestation in either primary care ( n = @ ) or secondary care ( n = @ ) locations . the primary outcome variable is the uptake rate of screening . secondary outcomes include indicators of clinical effectiveness of screening at each screening site ( primary and secondary ) including gestational week at time of screening , time to access antenatal diabetes services for women diagnosed with gdm , and pregnancy and neonatal outcomes for women with gdm . in addition , parallel economic and qualitative evaluations will be conducted . the trial will cover the period from the woman 's first hospital antenatal visit at @ to @ weeks gestation , until the completion of the pregnancy . current controlled trials : isrctn@ .
24,438,478
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "BACKGROUND" ]
[ "we report the role of relative lymphocyte count ( rlc ) as a potential biomarker with prognostic impact for catumaxomab efficacy and overall survival ( os ) based on a post hoc analysis of the pivotal phase ii/iii study of intraperitoneal catumaxomab treatment of malignant ascites .", "the impact of treatment and rlc on os was evaluated using multivariate cox models .", "kaplan-meier and log-rank tests were used for group comparisons .", "survival analyses were performed on the safety population -lsb- patients with paracentesis plus @ dose of catumaxomab ( n = @ ) and paracentesis alone ( n = @ ) -rsb- .", "determination of the optimal cutoff value for rlc was based on five optimality criteria .", "os was significantly longer with catumaxomab versus paracentesis alone ( p = @ ) .", "the @-month os rate with catumaxomab was @ % versus @ % with paracentesis alone .", "rlc had a positive impact on os and was an independent prognostic factor ( p < @ ) .", "in patients with rlc > @ % ( n = @ : catumaxomab , @ and control , @ ) , catumaxomab was associated with a favorable effect on os versus paracentesis alone ( p = @ ) , with a median/mean os benefit of @/@ days and an increased @-month survival rate of @ % versus @ % , respectively .", "in patients with rlc @ % at screening ( n = @ : catumaxomab , @ and control , @ ) , the median ( mean ) os difference between the catumaxomab and the control group was @ ( @ ) days , respectively ( p = @ ) .", "os was significantly improved after catumaxomab treatment in patients with malignant ascites .", "an rlc > @ % at baseline was a significant prognostic biomarker ." ]
we report the role of relative lymphocyte count ( rlc ) as a potential biomarker with prognostic impact for catumaxomab efficacy and overall survival ( os ) based on a post hoc analysis of the pivotal phase ii/iii study of intraperitoneal catumaxomab treatment of malignant ascites . the impact of treatment and rlc on os was evaluated using multivariate cox models . kaplan-meier and log-rank tests were used for group comparisons . survival analyses were performed on the safety population -lsb- patients with paracentesis plus @ dose of catumaxomab ( n = @ ) and paracentesis alone ( n = @ ) -rsb- . determination of the optimal cutoff value for rlc was based on five optimality criteria . os was significantly longer with catumaxomab versus paracentesis alone ( p = @ ) . the @-month os rate with catumaxomab was @ % versus @ % with paracentesis alone . rlc had a positive impact on os and was an independent prognostic factor ( p < @ ) . in patients with rlc > @ % ( n = @ : catumaxomab , @ and control , @ ) , catumaxomab was associated with a favorable effect on os versus paracentesis alone ( p = @ ) , with a median/mean os benefit of @/@ days and an increased @-month survival rate of @ % versus @ % , respectively . in patients with rlc @ % at screening ( n = @ : catumaxomab , @ and control , @ ) , the median ( mean ) os difference between the catumaxomab and the control group was @ ( @ ) days , respectively ( p = @ ) . os was significantly improved after catumaxomab treatment in patients with malignant ascites . an rlc > @ % at baseline was a significant prognostic biomarker .
24,714,773
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "primary percutaneous coronary intervention ( pci ) has considerably improved clinical outcomes in patients with st-segment elevation myocardial infarction ( stemi ) when compared with thrombolytic therapy .", "prognosis after primary pci might be further improved by decreasing stent-related complications such as stent thrombosis .", "the stentys self-apposing stent has been shown to be superior compared with balloon-expandable stents with regard to stent apposition .", "the current prospective randomized trial was designed to evaluate whether the superior stent apposition of the stentys stent results in clinical outcomes that are at least noninferior to a conventional balloon-expandable stent .", "the apposition v is a prospective , multicenter , international , single-blinded , randomized controlled trial in stemi patients .", "randomization will be performed in a @:@ ratio between the self-apposing nitinol bare-metal stentys stent and the balloon-expandable bare-metal multi-link .", "the primary end point is defined as target vessel failure , which is a composite of cardiac death , target vessel-related recurrent myocardial infarction , or clinically driven target vessel revascularization , at @-year follow-up .", "baseline intravascular ultrasound and optical coherence tomography ( oct ) substudies will be performed in @ and @ subjects , respectively , and a repeat angiography at @ to @ months will be performed in @ subjects , including intravascular ultrasound and oct ( in the @ oct patients ) .", "this study is registered on clinicaltrials.gov with number nct@ .", "apposition v will be the first randomized trial powered on clinical end points that directly compares the stentys self-apposing stent with a conventional balloon-expandable stent in patients presenting with stemi undergoing primary pci ." ]
primary percutaneous coronary intervention ( pci ) has considerably improved clinical outcomes in patients with st-segment elevation myocardial infarction ( stemi ) when compared with thrombolytic therapy . prognosis after primary pci might be further improved by decreasing stent-related complications such as stent thrombosis . the stentys self-apposing stent has been shown to be superior compared with balloon-expandable stents with regard to stent apposition . the current prospective randomized trial was designed to evaluate whether the superior stent apposition of the stentys stent results in clinical outcomes that are at least noninferior to a conventional balloon-expandable stent . the apposition v is a prospective , multicenter , international , single-blinded , randomized controlled trial in stemi patients . randomization will be performed in a @:@ ratio between the self-apposing nitinol bare-metal stentys stent and the balloon-expandable bare-metal multi-link . the primary end point is defined as target vessel failure , which is a composite of cardiac death , target vessel-related recurrent myocardial infarction , or clinically driven target vessel revascularization , at @-year follow-up . baseline intravascular ultrasound and optical coherence tomography ( oct ) substudies will be performed in @ and @ subjects , respectively , and a repeat angiography at @ to @ months will be performed in @ subjects , including intravascular ultrasound and oct ( in the @ oct patients ) . this study is registered on clinicaltrials.gov with number nct@ . apposition v will be the first randomized trial powered on clinical end points that directly compares the stentys self-apposing stent with a conventional balloon-expandable stent in patients presenting with stemi undergoing primary pci .
25,440,792
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS" ]
[ "reliability of coronary angiography by multidetector row ct ( mdct-ca ) for stent evaluation is still a matter for debate , and it is unknown whether contrast medium characteristics may affect diagnostic performance of mdct-ca .", "we compared iomeprol-@ with iodixanol-@ to evaluate coronary stents with mdct-ca .", "we randomly assigned @ patients undergoing coronary stent follow-up with the use of mdct-ca to iomeprol-@ at @ ml/sec flow rate ( group @ ; n = @ ) , iodixanol-@ at @ ml/sec flow rate ( group @ ; n = @ ) , and iodixanol-@ at @ ml/sec flow rate ( group @ ; n = @ ) .", "heart rate ( hr ) immediately before and at the end of scanning , hr variation , premature heart beats , and heat sensation by visual analog scale during scanning were recorded .", "mean attenuation was measured in the aortic root and coronary arteries .", "image quality score and type of artifacts were assessed .", "mean attenuation was significantly lower in group @ than in the other groups .", "in group @ , stent evaluability was significantly higher and artifact rate was significantly lower than in group @ ( @ % vs. @ % and @ % vs. @ % ) and group @ ( @ % vs. @ % and @ % vs. @ % ) , respectively , mainly because of a significant lower rate of beam-hardening artifacts ( @ cases in group @ vs. @ and @ in groups @ and @ , respectively ) .", "in group @ , visual analog scale , hr at the end of imaging , and number of patients with premature heart beats during the scan were significantly lower than in the other groups .", "iodixanol-@ provides better image quality of coronary stents , allowing higher mdct-ca evaluability , than iomeprol-@ ." ]
reliability of coronary angiography by multidetector row ct ( mdct-ca ) for stent evaluation is still a matter for debate , and it is unknown whether contrast medium characteristics may affect diagnostic performance of mdct-ca . we compared iomeprol-@ with iodixanol-@ to evaluate coronary stents with mdct-ca . we randomly assigned @ patients undergoing coronary stent follow-up with the use of mdct-ca to iomeprol-@ at @ ml/sec flow rate ( group @ ; n = @ ) , iodixanol-@ at @ ml/sec flow rate ( group @ ; n = @ ) , and iodixanol-@ at @ ml/sec flow rate ( group @ ; n = @ ) . heart rate ( hr ) immediately before and at the end of scanning , hr variation , premature heart beats , and heat sensation by visual analog scale during scanning were recorded . mean attenuation was measured in the aortic root and coronary arteries . image quality score and type of artifacts were assessed . mean attenuation was significantly lower in group @ than in the other groups . in group @ , stent evaluability was significantly higher and artifact rate was significantly lower than in group @ ( @ % vs. @ % and @ % vs. @ % ) and group @ ( @ % vs. @ % and @ % vs. @ % ) , respectively , mainly because of a significant lower rate of beam-hardening artifacts ( @ cases in group @ vs. @ and @ in groups @ and @ , respectively ) . in group @ , visual analog scale , hr at the end of imaging , and number of patients with premature heart beats during the scan were significantly lower than in the other groups . iodixanol-@ provides better image quality of coronary stents , allowing higher mdct-ca evaluability , than iomeprol-@ .
24,582,042
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the efficacy of pre-exposure prophylaxis ( prep ) in hiv will diminish with poor adherence ; pharmacologic measures of drug exposure have proven critical to prep trial interpretation .", "we assessed drug exposure in hair against other pharmacologic and more routinely used measures to assess pill-taking .", "participants were randomized to placebo , daily prep , or intermittent prep to evaluate safety and tolerability of daily versus intermittent tenofovir/emtricitabine ( tfv/ftc ) in @ phase ii prep clinical trials conducted in africa .", "different measures of drug exposure , including self-report , medication event monitoring system ( mems ) - caps openings , and tfv/ftc levels in hair and other biomatrices were compared .", "at weeks @ and @ , self-reported pill-taking , mems-caps openings , and tfv/ftc levels in hair , plasma , and peripheral blood mononuclear cells ( pbmcs ) were measured .", "regression models evaluated predictors of tfv/ftc concentrations in the @ biomatrices ; correlation coefficients between pharmacologic and nonpharmacologic measures were calculated .", "both trials were registered on clinicaltrials.gov ( nct@/nct@ ) .", "hair collection was highly feasible and acceptable ( @ % in week @ ; @ % in week @ ) .", "in multivariate analysis , strong associations were seen between pharmacologic measures and mems-caps openings ( all p < @ ) ; self-report was only weakly associated with pharmacologic measures .", "tfv/ftc hair concentrations were significantly correlated with levels in plasma and pbmcs ( correlation coefficients , @-@ @ , all p < @ ) .", "measuring tfv/ftc exposure in small hair samples in african prep trials was feasible and acceptable .", "hair levels correlated strongly with pbmc , plasma concentrations , and mems-caps openings .", "as in other prep trials , self-report was the weakest measure of exposure .", "further study of hair tfv/ftc levels in prep trials and demonstration projects to assess adherence/exposure is warranted ." ]
the efficacy of pre-exposure prophylaxis ( prep ) in hiv will diminish with poor adherence ; pharmacologic measures of drug exposure have proven critical to prep trial interpretation . we assessed drug exposure in hair against other pharmacologic and more routinely used measures to assess pill-taking . participants were randomized to placebo , daily prep , or intermittent prep to evaluate safety and tolerability of daily versus intermittent tenofovir/emtricitabine ( tfv/ftc ) in @ phase ii prep clinical trials conducted in africa . different measures of drug exposure , including self-report , medication event monitoring system ( mems ) - caps openings , and tfv/ftc levels in hair and other biomatrices were compared . at weeks @ and @ , self-reported pill-taking , mems-caps openings , and tfv/ftc levels in hair , plasma , and peripheral blood mononuclear cells ( pbmcs ) were measured . regression models evaluated predictors of tfv/ftc concentrations in the @ biomatrices ; correlation coefficients between pharmacologic and nonpharmacologic measures were calculated . both trials were registered on clinicaltrials.gov ( nct@/nct@ ) . hair collection was highly feasible and acceptable ( @ % in week @ ; @ % in week @ ) . in multivariate analysis , strong associations were seen between pharmacologic measures and mems-caps openings ( all p < @ ) ; self-report was only weakly associated with pharmacologic measures . tfv/ftc hair concentrations were significantly correlated with levels in plasma and pbmcs ( correlation coefficients , @-@ @ , all p < @ ) . measuring tfv/ftc exposure in small hair samples in african prep trials was feasible and acceptable . hair levels correlated strongly with pbmc , plasma concentrations , and mems-caps openings . as in other prep trials , self-report was the weakest measure of exposure . further study of hair tfv/ftc levels in prep trials and demonstration projects to assess adherence/exposure is warranted .
25,296,098
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "sleep apnea ( sa ) is associated with cardiovascular diseases and is highly prevalent in patients with pacemakers ( pms ) .", "to validate a transthoracic impedance sensor with an advanced algorithm ( sleep apnea monitoring ) for identifying severe sa .", "patients with indications for pm ( vvi/ddd ) were enrolled regardless of symptoms suggesting sa .", "severe sa diagnosis was acknowledged when the full polysomnography gave an apnea-hypopnea index ( psg-ahi ) of @ events/h .", "the psg-ahi was compared with the respiratory disturbance index evaluated by the sam algorithm ( sam-rdi ) compiled from the device during the same diagnosis night , and the performance of the device and the sam algorithm was calculated to identify patients with severe sa .", "the agreement between methods was assessed by using bland and altman statistics .", "forty patients ( mean age @ @ years ; @ % men ; body mass index @ @ kg/m ( @ ) ) were included .", "severe sa was diagnosed by psg in @ % of the patients .", "we did not retrieve sam-rdi data in @ % of the patients .", "an optimal cutoff value for the sam-rdi at @ events/h was obtained by a receiver operator characteristic curve analysis , which yielded a sensitivity of @ % ( @ % confidence interval -lsb- ci -rsb- @ % -@ % ) , a positive predictive value of @ % ( @ % ci @ % -@ % ) , and a specificity of @ % ( @ % ci @ % -@ % ) ( n = @ ) .", "the bland-altman limits of agreement for psg-ahi ( in events per hour ) were -lsb- -@ to @ -rsb- .", "the results suggest that an advanced algorithm using pm transthoracic impedance could be used to identify sa in patients with pms outside the clinic or at home ." ]
sleep apnea ( sa ) is associated with cardiovascular diseases and is highly prevalent in patients with pacemakers ( pms ) . to validate a transthoracic impedance sensor with an advanced algorithm ( sleep apnea monitoring ) for identifying severe sa . patients with indications for pm ( vvi/ddd ) were enrolled regardless of symptoms suggesting sa . severe sa diagnosis was acknowledged when the full polysomnography gave an apnea-hypopnea index ( psg-ahi ) of @ events/h . the psg-ahi was compared with the respiratory disturbance index evaluated by the sam algorithm ( sam-rdi ) compiled from the device during the same diagnosis night , and the performance of the device and the sam algorithm was calculated to identify patients with severe sa . the agreement between methods was assessed by using bland and altman statistics . forty patients ( mean age @ @ years ; @ % men ; body mass index @ @ kg/m ( @ ) ) were included . severe sa was diagnosed by psg in @ % of the patients . we did not retrieve sam-rdi data in @ % of the patients . an optimal cutoff value for the sam-rdi at @ events/h was obtained by a receiver operator characteristic curve analysis , which yielded a sensitivity of @ % ( @ % confidence interval -lsb- ci -rsb- @ % -@ % ) , a positive predictive value of @ % ( @ % ci @ % -@ % ) , and a specificity of @ % ( @ % ci @ % -@ % ) ( n = @ ) . the bland-altman limits of agreement for psg-ahi ( in events per hour ) were -lsb- -@ to @ -rsb- . the results suggest that an advanced algorithm using pm transthoracic impedance could be used to identify sa in patients with pms outside the clinic or at home .
24,561,163
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "although maintenance bacillus calmette-gurin ( bcg ) is the recommended treatment in high-risk non-muscle-invasive bladder cancer ( nmibc ) , its efficacy in older patients is controversial .", "to determine the effect of age on prognosis and treatment outcome in patients with stage ta t@ nmibc treated with maintenance bcg .", "a total of @ patients with intermediate - or high-risk ta t@ ( without carcinoma in situ ) nmibc were randomized in european organization for research and treatment of cancer ( eortc ) trial @ comparing six weekly instillations of epirubicin , bcg , and bcg plus isoniazid followed by three weekly maintenance instillations over @ yr .", "cox multivariate proportional hazards regression models were used to assess the relative importance of age for recurrence , progression , overall survival , and nmibc-specific survival with adjustment for eortc risk scores .", "overall , @ eligible patients were included : @ patients in the bcg with or without inh arms and @ in the epirubicin arm .", "in patients treated with bcg with or without inh , @ % were > @ yr of age and @ % were > @ yr .", "with a median follow-up of @ yr , patients > @ yr had a shorter time to progression ( p = @ ) , overall survival ( p < @ ) , and nmibc-specific survival ( p = @ ) after adjustment for eortc risk scores in the multivariate analysis .", "the time to recurrence was similar compared with the younger patients .", "bcg was more effective than epirubicin for all four end points considered , and there was no evidence that bcg was any less effective compared with epirubicin in patients > @ yr .", "in intermediate - and high-risk ta t@ urothelial bladder cancer patients treated with bcg , patients > @ yr of age have a worse long-term prognosis ; however , bcg is more effective than epirubicin independent of patient age .", "intravesical bacillus calmette-gurin for non-muscle-invasive bladder cancer is less effective in patients > @ yr of age , but it is still more effective than epirubicin .", "this study was registered with the us national cancer institute clinical trials database ( protocol id : eortc @ ; http://www.cancer.gov/clinicaltrials/search/view?cdrid=@&version=healthprofessional&protocolsearchid=@#studyidinfo_cdr@ ) ." ]
although maintenance bacillus calmette-gurin ( bcg ) is the recommended treatment in high-risk non-muscle-invasive bladder cancer ( nmibc ) , its efficacy in older patients is controversial . to determine the effect of age on prognosis and treatment outcome in patients with stage ta t@ nmibc treated with maintenance bcg . a total of @ patients with intermediate - or high-risk ta t@ ( without carcinoma in situ ) nmibc were randomized in european organization for research and treatment of cancer ( eortc ) trial @ comparing six weekly instillations of epirubicin , bcg , and bcg plus isoniazid followed by three weekly maintenance instillations over @ yr . cox multivariate proportional hazards regression models were used to assess the relative importance of age for recurrence , progression , overall survival , and nmibc-specific survival with adjustment for eortc risk scores . overall , @ eligible patients were included : @ patients in the bcg with or without inh arms and @ in the epirubicin arm . in patients treated with bcg with or without inh , @ % were > @ yr of age and @ % were > @ yr . with a median follow-up of @ yr , patients > @ yr had a shorter time to progression ( p = @ ) , overall survival ( p < @ ) , and nmibc-specific survival ( p = @ ) after adjustment for eortc risk scores in the multivariate analysis . the time to recurrence was similar compared with the younger patients . bcg was more effective than epirubicin for all four end points considered , and there was no evidence that bcg was any less effective compared with epirubicin in patients > @ yr . in intermediate - and high-risk ta t@ urothelial bladder cancer patients treated with bcg , patients > @ yr of age have a worse long-term prognosis ; however , bcg is more effective than epirubicin independent of patient age . intravesical bacillus calmette-gurin for non-muscle-invasive bladder cancer is less effective in patients > @ yr of age , but it is still more effective than epirubicin . this study was registered with the us national cancer institute clinical trials database ( protocol id : eortc @ ; http://www.cancer.gov/clinicaltrials/search/view?cdrid=@&version=healthprofessional&protocolsearchid=@#studyidinfo_cdr@ ) .
24,948,466
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "RESULTS", "BACKGROUND" ]
[ "patients with end stage renal disease on hemodialysis are affected by physiological and psychological stressors , which contribute to poor quality of life and negative clinical outcomes .", "depression , anxiety , and stress are highly prevalent in this population .", "effective interventional strategies are required to manage these psychological symptoms .", "acupressure has been believed to be one of the complementary therapies that could promote psychological wellbeing .", "the aim of this study was to evaluate the effects of acupressure on depression , anxiety , stress , and general psychological distress in patients with hemodialysis .", "open-label randomized controlled trial .", "three hemodialysis centers .", "a total of @ patients with hemodialysis were randomly recruited into the acupressure group ( n = @ ) and the control group ( n = @ ) .", "the intervention was carried out from january to march @ .", "the acupressure group received routine hemodialysis treatment plus @ min acupressure applied three times a week for four weeks .", "the control group received only usual care with routine hemodialysis treatment .", "the outcome measurements were the depression , anxiety stress scales ( dass-@ ) , and general psychological distress using the general health questionnaire ( ghq-@ ) .", "statistical analysis was performed using wilcoxon signed-rank test to compare dass scales and ghq-@ scores before and after acupressure intervention .", "the acupressure group had significantly lower dass scores and ghq scores compared to the control group , signifying improvements in depression , anxiety , stress and general psychological distress .", "the sub-score of the ghq-@ for social dysfunction , however , were similar in both groups .", "findings from this study indicates that acupressure therapy delivered three times a week for four weeks was able to significantly reduce depression , anxiety , stress , and general psychological distress in patients with hemodialysis .", "this positive finding suggests that acupressure may have a role in promoting psychological wellbeing of patients .", "promoting psychological wellness will improve patients ' quality of life , and reduce negative outcomes associated with psychological illnesses and distress experienced by patients with hemodialysis ." ]
patients with end stage renal disease on hemodialysis are affected by physiological and psychological stressors , which contribute to poor quality of life and negative clinical outcomes . depression , anxiety , and stress are highly prevalent in this population . effective interventional strategies are required to manage these psychological symptoms . acupressure has been believed to be one of the complementary therapies that could promote psychological wellbeing . the aim of this study was to evaluate the effects of acupressure on depression , anxiety , stress , and general psychological distress in patients with hemodialysis . open-label randomized controlled trial . three hemodialysis centers . a total of @ patients with hemodialysis were randomly recruited into the acupressure group ( n = @ ) and the control group ( n = @ ) . the intervention was carried out from january to march @ . the acupressure group received routine hemodialysis treatment plus @ min acupressure applied three times a week for four weeks . the control group received only usual care with routine hemodialysis treatment . the outcome measurements were the depression , anxiety stress scales ( dass-@ ) , and general psychological distress using the general health questionnaire ( ghq-@ ) . statistical analysis was performed using wilcoxon signed-rank test to compare dass scales and ghq-@ scores before and after acupressure intervention . the acupressure group had significantly lower dass scores and ghq scores compared to the control group , signifying improvements in depression , anxiety , stress and general psychological distress . the sub-score of the ghq-@ for social dysfunction , however , were similar in both groups . findings from this study indicates that acupressure therapy delivered three times a week for four weeks was able to significantly reduce depression , anxiety , stress , and general psychological distress in patients with hemodialysis . this positive finding suggests that acupressure may have a role in promoting psychological wellbeing of patients . promoting psychological wellness will improve patients ' quality of life , and reduce negative outcomes associated with psychological illnesses and distress experienced by patients with hemodialysis .
25,468,282
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "botulinum toxins have been widely used in cosmetic dermatology .", "neurotoxin from the cbfc@ strain ( ntc ) is a recently developed botulinum toxin type a product manufactured through refined procedures .", "a double-blinded , randomized , multicentre-designed , phase iii trial to investigate the non-inferiority of ntc to existing botulinum toxin a , onabotulinumtoxin a in the treatment of moderate to severe glabellar lines .", "a total of @ subjects were randomized in a @ : @ ratio to receive @ u of ntc or onabotulinumtoxin a.", "the primary endpoint was the response rate of physicians ' assessment ( pa ) using the facial wrinkle scale at week @ .", "the secondary endpoints included the response rate of pa at weeks @ , @ and @ , and photographic assessment at weeks @ , @ , @ and @ .", "subjects ' improvement assessment and subjective self-satisfaction levels were also investigated .", "response rates for maximum frown were @ % in the ntc group and @ % in the onabotulinumtoxin a group at week @ .", "ntc also resulted in comparable results for both the response rates of the other evaluation points and incidence of adverse events compared to those of onabotulinumtoxin a.", "in subjects ' improvement assessment and photographic evaluations , ntc even demonstrated better results compared with onabotulinumtoxin a in the early phase after treatment .", "analysis of these results strongly supports the non-inferiority of ntc to onabotulinumtoxin a in the efficacy and safety .", "ntc is as effective as onabotulinumtoxin a in the treatment of glabellar lines , and both products were well tolerated ." ]
botulinum toxins have been widely used in cosmetic dermatology . neurotoxin from the cbfc@ strain ( ntc ) is a recently developed botulinum toxin type a product manufactured through refined procedures . a double-blinded , randomized , multicentre-designed , phase iii trial to investigate the non-inferiority of ntc to existing botulinum toxin a , onabotulinumtoxin a in the treatment of moderate to severe glabellar lines . a total of @ subjects were randomized in a @ : @ ratio to receive @ u of ntc or onabotulinumtoxin a. the primary endpoint was the response rate of physicians ' assessment ( pa ) using the facial wrinkle scale at week @ . the secondary endpoints included the response rate of pa at weeks @ , @ and @ , and photographic assessment at weeks @ , @ , @ and @ . subjects ' improvement assessment and subjective self-satisfaction levels were also investigated . response rates for maximum frown were @ % in the ntc group and @ % in the onabotulinumtoxin a group at week @ . ntc also resulted in comparable results for both the response rates of the other evaluation points and incidence of adverse events compared to those of onabotulinumtoxin a. in subjects ' improvement assessment and photographic evaluations , ntc even demonstrated better results compared with onabotulinumtoxin a in the early phase after treatment . analysis of these results strongly supports the non-inferiority of ntc to onabotulinumtoxin a in the efficacy and safety . ntc is as effective as onabotulinumtoxin a in the treatment of glabellar lines , and both products were well tolerated .
24,593,323
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to determine whether endometrial hcg infusion at the time of human blastocyst transfer impacts implantation rates .", "randomized double-blinded placebo-controlled trial .", "academic .", "infertile couples with the female partner less than @ years old ( n = @ ) undergoing fresh or frozen et of one or two blastocysts .", "patients undergoing et were randomized into either a treatment or a control group .", "the treatment group received an infusion of @ iu of hcg diluted in et media .", "the control group received a sham infusion of et media .", "infusions were done using a separate catheter less than @ minutes before actual et .", "sustained implantation rate : ongoing viable gestation ( primary outcome ) and ongoing pregnancy rate ( secondary outcome ) .", "a total of @ blastocysts were transferred into @ patients .", "there were no differences between the two groups in sustained implantation rate ( @ % in the hcg group , @ % in the control group ) or ongoing pregnancy rate ( @ % in the hcg group , @ % in the control group ) .", "endometrial infusion of hcg at the time of blastocyst et does not improve sustained implantation rates .", "nct@ ." ]
to determine whether endometrial hcg infusion at the time of human blastocyst transfer impacts implantation rates . randomized double-blinded placebo-controlled trial . academic . infertile couples with the female partner less than @ years old ( n = @ ) undergoing fresh or frozen et of one or two blastocysts . patients undergoing et were randomized into either a treatment or a control group . the treatment group received an infusion of @ iu of hcg diluted in et media . the control group received a sham infusion of et media . infusions were done using a separate catheter less than @ minutes before actual et . sustained implantation rate : ongoing viable gestation ( primary outcome ) and ongoing pregnancy rate ( secondary outcome ) . a total of @ blastocysts were transferred into @ patients . there were no differences between the two groups in sustained implantation rate ( @ % in the hcg group , @ % in the control group ) or ongoing pregnancy rate ( @ % in the hcg group , @ % in the control group ) . endometrial infusion of hcg at the time of blastocyst et does not improve sustained implantation rates . nct@ .
25,234,040
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]
[ "daily oral antiretroviral preexposure prophylaxis ( prep ) is a promising strategy for prevention of hiv-@ acquisition .", "three clinical trials demonstrated prep efficacy ; however , two prep trials among women did not find protection against hiv-@ .", "one hypothesis proposed for these divergent results is that prep efficacy may be reduced in populations with higher hiv-@ incidence .", "using data from the partners prep study , a randomized , placebo-controlled trial of daily oral tenofovir ( tdf ) and emtricitabine/tenofovir ( ftc/tdf ) prep among heterosexual hiv-@ serodiscordant couples from kenya and uganda , we assessed prep efficacy among subgroups at higher risk for hiv-@ acquisition , including subgroups of women with high hiv-@ incidence .", "the overall placebo arm hiv-@ incidence was @ per @ person-years .", "among higher risk subgroups , placebo arm hiv-@ incidence ranged from @ to @ per @ person-years .", "in all subgroups , prep was protective against hiv-@ acquisition , with efficacy point estimates ranging from @ to @ % .", "among subgroups of women with placebo-arm hiv-@ incidence more than @ , efficacy estimates ranged from @ to @ % .", "monthly visit attendance for prep refills and tenofovir detection in plasma were high .", "among higher-risk subgroups in the partners prep study , including groups solely of higher-risk women , both tdf alone and combined ftc/tdf prep had consistently high efficacy for hiv-@ protection .", "prep , when used with high adherence , is a highly effective prevention strategy for higher risk heterosexuals .", "prioritizing prep for persons at high risk of hiv-@ will maximize its prevention impact ." ]
daily oral antiretroviral preexposure prophylaxis ( prep ) is a promising strategy for prevention of hiv-@ acquisition . three clinical trials demonstrated prep efficacy ; however , two prep trials among women did not find protection against hiv-@ . one hypothesis proposed for these divergent results is that prep efficacy may be reduced in populations with higher hiv-@ incidence . using data from the partners prep study , a randomized , placebo-controlled trial of daily oral tenofovir ( tdf ) and emtricitabine/tenofovir ( ftc/tdf ) prep among heterosexual hiv-@ serodiscordant couples from kenya and uganda , we assessed prep efficacy among subgroups at higher risk for hiv-@ acquisition , including subgroups of women with high hiv-@ incidence . the overall placebo arm hiv-@ incidence was @ per @ person-years . among higher risk subgroups , placebo arm hiv-@ incidence ranged from @ to @ per @ person-years . in all subgroups , prep was protective against hiv-@ acquisition , with efficacy point estimates ranging from @ to @ % . among subgroups of women with placebo-arm hiv-@ incidence more than @ , efficacy estimates ranged from @ to @ % . monthly visit attendance for prep refills and tenofovir detection in plasma were high . among higher-risk subgroups in the partners prep study , including groups solely of higher-risk women , both tdf alone and combined ftc/tdf prep had consistently high efficacy for hiv-@ protection . prep , when used with high adherence , is a highly effective prevention strategy for higher risk heterosexuals . prioritizing prep for persons at high risk of hiv-@ will maximize its prevention impact .
24,384,592
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the anti-programmed-death-receptor-@ ( pd-@ ) antibody pembrolizumab has shown potent antitumour activity at different doses and schedules in patients with melanoma .", "we compared the efficacy and safety of pembrolizumab at doses of @ mg/kg and @ mg/kg every @ weeks in patients with ipilimumab-refractory advanced melanoma .", "in an open-label , international , multicentre expansion cohort of a phase @ trial , patients ( aged @ years ) with advanced melanoma whose disease had progressed after at least two ipilimumab doses were randomly assigned with a computer-generated allocation schedule ( @:@ final ratio ) to intravenous pembrolizumab at @ mg/kg every @ weeks or @ mg/kg every @ weeks until disease progression , intolerable toxicity , or consent withdrawal .", "primary endpoint was overall response rate ( orr ) assessed with the response evaluation criteria in solid tumors ( recist , version @ ) by independent central review .", "analysis was done on the full-analysis set ( all treated patients with measurable disease at baseline ) .", "this study is registered with clinicaltrials.gov , number nct@ .", "@ patients received pembrolizumab @ mg/kg ( n = @ ) or @ mg/kg ( n = @ ) .", "median follow-up duration was @ months .", "orr was @ % at both doses -- @ of @ patients in the @ mg/kg group and @ of @ in the @ mg/kg group ( difference @ % , @ % ci -@ to @ ; p = @ ) .", "treatment was well tolerated , with similar safety profiles in the @ mg/kg and @ mg/kg groups and no drug-related deaths .", "the most common drug-related adverse events of any grade in the @ mg/kg and @ mg/kg groups were fatigue ( @ -lsb- @ % -rsb- vs @ -lsb- @ % -rsb- ) , pruritus ( @ -lsb- @ % -rsb- vs @ -lsb- @ % -rsb- ) , and rash ( @ -lsb- @ % -rsb- vs @ -lsb- @ % -rsb- ) .", "grade @ fatigue , reported in five ( @ % ) patients in the @ mg/kg pembrolizumab group , was the only drug-related grade @ to @ adverse event reported in more than one patient .", "the results suggest that pembrolizumab at a dose of @ mg/kg or @ mg/kg every @ weeks might be an effective treatment in patients for whom there are few effective treatment options .", "merck sharp and dohme ." ]
the anti-programmed-death-receptor-@ ( pd-@ ) antibody pembrolizumab has shown potent antitumour activity at different doses and schedules in patients with melanoma . we compared the efficacy and safety of pembrolizumab at doses of @ mg/kg and @ mg/kg every @ weeks in patients with ipilimumab-refractory advanced melanoma . in an open-label , international , multicentre expansion cohort of a phase @ trial , patients ( aged @ years ) with advanced melanoma whose disease had progressed after at least two ipilimumab doses were randomly assigned with a computer-generated allocation schedule ( @:@ final ratio ) to intravenous pembrolizumab at @ mg/kg every @ weeks or @ mg/kg every @ weeks until disease progression , intolerable toxicity , or consent withdrawal . primary endpoint was overall response rate ( orr ) assessed with the response evaluation criteria in solid tumors ( recist , version @ ) by independent central review . analysis was done on the full-analysis set ( all treated patients with measurable disease at baseline ) . this study is registered with clinicaltrials.gov , number nct@ . @ patients received pembrolizumab @ mg/kg ( n = @ ) or @ mg/kg ( n = @ ) . median follow-up duration was @ months . orr was @ % at both doses -- @ of @ patients in the @ mg/kg group and @ of @ in the @ mg/kg group ( difference @ % , @ % ci -@ to @ ; p = @ ) . treatment was well tolerated , with similar safety profiles in the @ mg/kg and @ mg/kg groups and no drug-related deaths . the most common drug-related adverse events of any grade in the @ mg/kg and @ mg/kg groups were fatigue ( @ -lsb- @ % -rsb- vs @ -lsb- @ % -rsb- ) , pruritus ( @ -lsb- @ % -rsb- vs @ -lsb- @ % -rsb- ) , and rash ( @ -lsb- @ % -rsb- vs @ -lsb- @ % -rsb- ) . grade @ fatigue , reported in five ( @ % ) patients in the @ mg/kg pembrolizumab group , was the only drug-related grade @ to @ adverse event reported in more than one patient . the results suggest that pembrolizumab at a dose of @ mg/kg or @ mg/kg every @ weeks might be an effective treatment in patients for whom there are few effective treatment options . merck sharp and dohme .
25,034,862
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]
[ "the aim of this study was to analyze diurnal profiles of physical activity for community-dwelling adults aged @ years and over , and to explore the moderating effect of sex , age , morbidity , mobility limitation , and season on physical activity throughout the day .", "a sample of @ primary health care patients ( mean age @ @ years , @ % females ) was included in the analyses .", "participants ' physical activity was measured on up to six consecutive days via omron walking style pro hj-@it-e@ pedometer .", "step count per day and per hour , and pedometer wear time were descriptively analyzed .", "a repeated measures anova with physical activity per hour as dependent variable was performed to analyze the moderating effect of sex , age , morbidity , mobility limitation , and season on diurnal profiles of physical activity .", "the diurnal profile for the total sample and adjusted diurnal profiles for subgroups are presented .", "participants ' daily step count averaged @ @ steps/day .", "they wore the pedometer for @ @ hours per day and walked on average @ @ steps per hour .", "with respect to diurnal profiles , there were two peaks at @-@ am ( mean -lsb- @ % - confidence interval -rsb- : @ -lsb- @-@ -rsb- steps ) and at @-@ pm ( @ -lsb- @-@ -rsb- steps ) interrupted by a period of lower activity with a low point at @-@ pm ( @ -lsb- @-@ -rsb- steps ) .", "a mobility limitation , defined by use of a cane or a rollator , had a significant moderating effect ( p = @ ) on diurnal physical activity .", "this is the first study to explore pedometer-determined diurnal profiles of physical activity in chronically ill and mobility-limited older adults .", "prolonging periods of elevated physical activity in the afternoon while respecting individual daily routine and commitments could be one option for facilitating the integration of physical activity and for making it a habit in older adults ' daily lives .", "the use of a walking aid seems to be an indicator for a quite low activity plateau during the second half of the day .", "people who use walking aids should be motivated to increase their physical activity during afternoon ; this might help to increase the overall low physical activity level of this vulnerable subgroup of older adults ." ]
the aim of this study was to analyze diurnal profiles of physical activity for community-dwelling adults aged @ years and over , and to explore the moderating effect of sex , age , morbidity , mobility limitation , and season on physical activity throughout the day . a sample of @ primary health care patients ( mean age @ @ years , @ % females ) was included in the analyses . participants ' physical activity was measured on up to six consecutive days via omron walking style pro hj-@it-e@ pedometer . step count per day and per hour , and pedometer wear time were descriptively analyzed . a repeated measures anova with physical activity per hour as dependent variable was performed to analyze the moderating effect of sex , age , morbidity , mobility limitation , and season on diurnal profiles of physical activity . the diurnal profile for the total sample and adjusted diurnal profiles for subgroups are presented . participants ' daily step count averaged @ @ steps/day . they wore the pedometer for @ @ hours per day and walked on average @ @ steps per hour . with respect to diurnal profiles , there were two peaks at @-@ am ( mean -lsb- @ % - confidence interval -rsb- : @ -lsb- @-@ -rsb- steps ) and at @-@ pm ( @ -lsb- @-@ -rsb- steps ) interrupted by a period of lower activity with a low point at @-@ pm ( @ -lsb- @-@ -rsb- steps ) . a mobility limitation , defined by use of a cane or a rollator , had a significant moderating effect ( p = @ ) on diurnal physical activity . this is the first study to explore pedometer-determined diurnal profiles of physical activity in chronically ill and mobility-limited older adults . prolonging periods of elevated physical activity in the afternoon while respecting individual daily routine and commitments could be one option for facilitating the integration of physical activity and for making it a habit in older adults ' daily lives . the use of a walking aid seems to be an indicator for a quite low activity plateau during the second half of the day . people who use walking aids should be motivated to increase their physical activity during afternoon ; this might help to increase the overall low physical activity level of this vulnerable subgroup of older adults .
25,495,494
[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "we evaluated the endogenous glucose production ( egp ) and glucose disposal rate ( gdr ) over a range of doses of basal insulin peglispro ( bil ) and insulin glargine in healthy subjects .", "this was a single-center , randomized , open-label , four-period , incomplete-block , crossover study conducted in eight healthy male subjects .", "subjects had @-h euglycemic clamps performed with primed , continuous infusions of bil ( @ to @ mu/min ) in three dosing periods and insulin glargine ( @ or @ mu/m ( @ ) / min ) in a fourth period , targeted to achieve @-@ % suppression of egp .", "d - -lsb- @ - ( @ ) h -rsb- glucose was infused to assess rates of glucose appearance and disappearance .", "mean bil and insulin glargine concentrations ( targeted to reflect the differences in intrinsic affinities of the two basal insulins ) ranged from @ to @,@ and @ to @ pmol/l , respectively , and increased accordingly with increases in dose .", "suppression of egp and stimulation of gdr were observed with increasing concentrations of both insulins .", "at insulin concentrations where egp was significantly suppressed , insulin glargine resulted in increased gdr .", "in contrast , at comparable suppression of egp , bil had minimal effect on gdr at lower doses and had substantially less effect on gdr than insulin glargine at higher doses .", "the novel basal insulin analog bil has relative hepatopreferential action and decreased peripheral action , compared with insulin glargine , in healthy subjects ." ]
we evaluated the endogenous glucose production ( egp ) and glucose disposal rate ( gdr ) over a range of doses of basal insulin peglispro ( bil ) and insulin glargine in healthy subjects . this was a single-center , randomized , open-label , four-period , incomplete-block , crossover study conducted in eight healthy male subjects . subjects had @-h euglycemic clamps performed with primed , continuous infusions of bil ( @ to @ mu/min ) in three dosing periods and insulin glargine ( @ or @ mu/m ( @ ) / min ) in a fourth period , targeted to achieve @-@ % suppression of egp . d - -lsb- @ - ( @ ) h -rsb- glucose was infused to assess rates of glucose appearance and disappearance . mean bil and insulin glargine concentrations ( targeted to reflect the differences in intrinsic affinities of the two basal insulins ) ranged from @ to @,@ and @ to @ pmol/l , respectively , and increased accordingly with increases in dose . suppression of egp and stimulation of gdr were observed with increasing concentrations of both insulins . at insulin concentrations where egp was significantly suppressed , insulin glargine resulted in increased gdr . in contrast , at comparable suppression of egp , bil had minimal effect on gdr at lower doses and had substantially less effect on gdr than insulin glargine at higher doses . the novel basal insulin analog bil has relative hepatopreferential action and decreased peripheral action , compared with insulin glargine , in healthy subjects .
24,947,791
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the consequences of alcohol dependence are severe and may range from physical disease to neuropsychological deficits in several cognitive domains .", "alcohol abuse has also been related to brain dysfunction specifically in the prefrontal cortex .", "conventional neuropsychological interventions ( paper-and-pencil cognitive stimulation training ) have a positive effect but are time-consuming , costly , and not motivating for patients .", "our goal was to test the cognitive effects of a novel approach to neuropsychological intervention , using mobile technology and serious games , on patients with alcohol dependence .", "the trial design consisted of a two-arm study assessing the cognitive outcomes of neuropsychological intervention with mobile serious games ( mhealth ) versus control ( treatment-as-usual with no neuropsychological intervention ) in patients undergoing treatment for alcohol dependence syndrome .", "sixty-eight patients were recruited from an alcohol-rehab clinic and randomly assigned to the mhealth ( n = @ ) or control condition ( n = @ ) .", "the intervention on the experimental group consisted of a therapist-assisted cognitive stimulation therapy for @ weeks on a @-@ days/week basis .", "fourteen patients dropped out of the study .", "the results of the neuropsychological assessments with the remaining @ patients showed an overall increase ( p < @ ) of general cognitive abilities , mental flexibility , psychomotor processing speed , and attentional ability in both experimental ( n = @ ) and control groups ( n = @ ) .", "however , there was a more pronounced improvement ( p = @ ) specifically in frontal lobe functions from baseline ( mean @ , se @ ) to follow-up ( mean @ , se @ ) in the experimental group but not in the control group .", "the overall increase in general cognitive function for both experimental and control groups supports the beneficial role of existing alcohol treatment protocols aimed at minimizing withdrawal symptoms , but the differential improvements observed in frontal lobe functioning supports the use of mobile serious games for neuropsychological stimulation to overcome executive dysfunction in patients with alcohol dependence .", "this trial was negative on two neuropsychological/cognitive tests , and positive on one .", "clinicaltrials.gov nct@ ; http://www.clinicaltrials.gov/ct@/show/nct@ ." ]
the consequences of alcohol dependence are severe and may range from physical disease to neuropsychological deficits in several cognitive domains . alcohol abuse has also been related to brain dysfunction specifically in the prefrontal cortex . conventional neuropsychological interventions ( paper-and-pencil cognitive stimulation training ) have a positive effect but are time-consuming , costly , and not motivating for patients . our goal was to test the cognitive effects of a novel approach to neuropsychological intervention , using mobile technology and serious games , on patients with alcohol dependence . the trial design consisted of a two-arm study assessing the cognitive outcomes of neuropsychological intervention with mobile serious games ( mhealth ) versus control ( treatment-as-usual with no neuropsychological intervention ) in patients undergoing treatment for alcohol dependence syndrome . sixty-eight patients were recruited from an alcohol-rehab clinic and randomly assigned to the mhealth ( n = @ ) or control condition ( n = @ ) . the intervention on the experimental group consisted of a therapist-assisted cognitive stimulation therapy for @ weeks on a @-@ days/week basis . fourteen patients dropped out of the study . the results of the neuropsychological assessments with the remaining @ patients showed an overall increase ( p < @ ) of general cognitive abilities , mental flexibility , psychomotor processing speed , and attentional ability in both experimental ( n = @ ) and control groups ( n = @ ) . however , there was a more pronounced improvement ( p = @ ) specifically in frontal lobe functions from baseline ( mean @ , se @ ) to follow-up ( mean @ , se @ ) in the experimental group but not in the control group . the overall increase in general cognitive function for both experimental and control groups supports the beneficial role of existing alcohol treatment protocols aimed at minimizing withdrawal symptoms , but the differential improvements observed in frontal lobe functioning supports the use of mobile serious games for neuropsychological stimulation to overcome executive dysfunction in patients with alcohol dependence . this trial was negative on two neuropsychological/cognitive tests , and positive on one . clinicaltrials.gov nct@ ; http://www.clinicaltrials.gov/ct@/show/nct@ .
24,742,381
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "to assess the efficacy of oral transmucosal meloxicam for pain relief in lambs at marking .", "a blinded , placebo-controlled , randomised , block design field study of @ merino lambs aged @-@ weeks allocated to placebo and meloxicam treatments and studied in two cohorts of @ .", "placebo-treated lambs received @ml/@kg of drug vehicle and meloxicam-treated lambs received @mg/kg meloxicam at @mg/ml .", "treatments were administered into the buccal cavity immediately before knife castration and hot-iron tail docking .", "lambs were then released into a grassed paddock ( @ ha ) .", "time to mother-up was recorded and behaviours were observed every @min for @h and again for @min at @h .", "the sequence in which lambs exited the paddock with their mothers was then recorded .", "weight change and wound scores were recorded @ and @ days after marking .", "meloxicam did not affect mothering-up .", "in the @h following marking , meloxicam led to a @-fold reduction ( p < @ ) in combined abnormal behaviours ( hunched standing , standing with a stretched posture , walking stiffly ) .", "the meloxicam group spent significantly less time in standing postures and tended to spend more time grazing , suckling and in normal lying postures .", "at @h , the meloxicam group spent more time lying and less time standing .", "there was no effect of treatments on the sequence in which lambs moved into a fresh paddock or on weight change .", "the buccal meloxicam formulation provided substantial analgesia to lambs on the day of marking .", "slight benefits were evident the following morning ." ]
to assess the efficacy of oral transmucosal meloxicam for pain relief in lambs at marking . a blinded , placebo-controlled , randomised , block design field study of @ merino lambs aged @-@ weeks allocated to placebo and meloxicam treatments and studied in two cohorts of @ . placebo-treated lambs received @ml/@kg of drug vehicle and meloxicam-treated lambs received @mg/kg meloxicam at @mg/ml . treatments were administered into the buccal cavity immediately before knife castration and hot-iron tail docking . lambs were then released into a grassed paddock ( @ ha ) . time to mother-up was recorded and behaviours were observed every @min for @h and again for @min at @h . the sequence in which lambs exited the paddock with their mothers was then recorded . weight change and wound scores were recorded @ and @ days after marking . meloxicam did not affect mothering-up . in the @h following marking , meloxicam led to a @-fold reduction ( p < @ ) in combined abnormal behaviours ( hunched standing , standing with a stretched posture , walking stiffly ) . the meloxicam group spent significantly less time in standing postures and tended to spend more time grazing , suckling and in normal lying postures . at @h , the meloxicam group spent more time lying and less time standing . there was no effect of treatments on the sequence in which lambs moved into a fresh paddock or on weight change . the buccal meloxicam formulation provided substantial analgesia to lambs on the day of marking . slight benefits were evident the following morning .
25,256,843
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "coronary artery bypass grafting success is limited by vein graft failure ( vgf ) .", "understanding the factors associated with vgf may improve patient outcomes .", "we examined @ participants in the project of ex vivo vein graft engineering via transfection iv ( prevent iv ) trial undergoing protocol-mandated follow-up angiography @ to @ months post-coronary artery bypass grafting or earlier clinically driven angiography .", "outcomes included patient - and graft-level angiographic vgf ( @ % stenosis or occlusion ) .", "variables were selected by using fast false selection rate methodology .", "we examined relationships between variables and vgf in patient - and graft-level models by using logistic regression without and with generalized estimating equations .", "at @ to @ months post-coronary artery bypass grafting , @ of @ ( @ % ) patients had vgf , and @ of @ ( @ % ) vein grafts had failed .", "demographic and clinical characteristics were similar between patients with and without vgf , although vgf patients had longer surgical times , worse target artery quality , longer graft length , and they more frequently underwent endoscopic vein harvesting .", "after multivariable adjustment , longer surgical duration ( odds ratio per @-minute increase , @ ; @ % confidence interval , @-@ @ ) , endoscopic vein harvesting ( odds ratio , @ ; @ % confidence interval , @-@ @ ) , poor target artery quality ( odds ratio , @ ; @ % confidence interval , @-@ @ ) , and postoperative use of clopidogrel or ticlopidine ( odds ratio , @ ; @ % confidence interval , @-@ @ ) were associated with patient-level vgf .", "the predicted likelihood of vgf in the graft-level model ranged from @ % to @ % .", "vgf is common and associated with patient and surgical factors .", "these findings may help identify patients with risk factors for vgf and inform the development of interventions to reduce vgf .", "http://www.clinicaltrials.gov .", "unique identifier : nct@ ." ]
coronary artery bypass grafting success is limited by vein graft failure ( vgf ) . understanding the factors associated with vgf may improve patient outcomes . we examined @ participants in the project of ex vivo vein graft engineering via transfection iv ( prevent iv ) trial undergoing protocol-mandated follow-up angiography @ to @ months post-coronary artery bypass grafting or earlier clinically driven angiography . outcomes included patient - and graft-level angiographic vgf ( @ % stenosis or occlusion ) . variables were selected by using fast false selection rate methodology . we examined relationships between variables and vgf in patient - and graft-level models by using logistic regression without and with generalized estimating equations . at @ to @ months post-coronary artery bypass grafting , @ of @ ( @ % ) patients had vgf , and @ of @ ( @ % ) vein grafts had failed . demographic and clinical characteristics were similar between patients with and without vgf , although vgf patients had longer surgical times , worse target artery quality , longer graft length , and they more frequently underwent endoscopic vein harvesting . after multivariable adjustment , longer surgical duration ( odds ratio per @-minute increase , @ ; @ % confidence interval , @-@ @ ) , endoscopic vein harvesting ( odds ratio , @ ; @ % confidence interval , @-@ @ ) , poor target artery quality ( odds ratio , @ ; @ % confidence interval , @-@ @ ) , and postoperative use of clopidogrel or ticlopidine ( odds ratio , @ ; @ % confidence interval , @-@ @ ) were associated with patient-level vgf . the predicted likelihood of vgf in the graft-level model ranged from @ % to @ % . vgf is common and associated with patient and surgical factors . these findings may help identify patients with risk factors for vgf and inform the development of interventions to reduce vgf . http://www.clinicaltrials.gov . unique identifier : nct@ .
25,261,549
[ "BACKGROUND", "BACKGROUND", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND" ]
[ "the insulin secretion/insulin resistance ( ir ) ( disposition ) index ( i/g ir , where is change from baseline , i is insulin , and g is glucose ) is commonly used as a measure of - cell function .", "this relationship is curvilinear and becomes linear when log transformed .", "i is determined by @ variables : insulin secretion rate ( isr ) and metabolic clearance of insulin .", "we postulated that the characteristic curvilinear relationship would be lost if plasma c-peptide ( cp ) ( instead of plasma insulin ) was plotted against insulin sensitivity .", "a total of @ individuals with impaired glucose tolerance ( igt ) from act now received an oral glucose tolerance test and were randomized to pioglitazone or placebo for @ years .", "pioglitazone reduced igt conversion to diabetes by @ % ( p < @ ) .", "i/g vs the matsuda index of insulin sensitivity showed the characteristic curvilinear relationship .", "however , when cp/g or isr/g was plotted against the matsuda index , the curvilinear relationship was completely lost .", "this discordance was explained by @ distinct physiologic effects that altered plasma insulin response in opposite directions : @ ) increased isr and @ ) augmented metabolic clearance of insulin .", "the net result was a decline in the plasma insulin response to hyperglycemia during the oral glucose tolerance test .", "these findings demonstrate a physiologic control mechanism wherein the increase in isr ensures adequate insulin delivery into the portal circulation to suppress hepatic glucose production while delivering a reduced but sufficient amount of insulin to peripheral tissues to maintain the pioglitazone-mediated improvement in insulin sensitivity without excessive hyperinsulinemia .", "these results demonstrate the validity of the disposition index when relating the plasma insulin response to insulin sensitivity but underscore the pitfall of this index when drawing conclusions about - cell function , because insulin secretion declined despite an increase in the plasma insulin response ." ]
the insulin secretion/insulin resistance ( ir ) ( disposition ) index ( i/g ir , where is change from baseline , i is insulin , and g is glucose ) is commonly used as a measure of - cell function . this relationship is curvilinear and becomes linear when log transformed . i is determined by @ variables : insulin secretion rate ( isr ) and metabolic clearance of insulin . we postulated that the characteristic curvilinear relationship would be lost if plasma c-peptide ( cp ) ( instead of plasma insulin ) was plotted against insulin sensitivity . a total of @ individuals with impaired glucose tolerance ( igt ) from act now received an oral glucose tolerance test and were randomized to pioglitazone or placebo for @ years . pioglitazone reduced igt conversion to diabetes by @ % ( p < @ ) . i/g vs the matsuda index of insulin sensitivity showed the characteristic curvilinear relationship . however , when cp/g or isr/g was plotted against the matsuda index , the curvilinear relationship was completely lost . this discordance was explained by @ distinct physiologic effects that altered plasma insulin response in opposite directions : @ ) increased isr and @ ) augmented metabolic clearance of insulin . the net result was a decline in the plasma insulin response to hyperglycemia during the oral glucose tolerance test . these findings demonstrate a physiologic control mechanism wherein the increase in isr ensures adequate insulin delivery into the portal circulation to suppress hepatic glucose production while delivering a reduced but sufficient amount of insulin to peripheral tissues to maintain the pioglitazone-mediated improvement in insulin sensitivity without excessive hyperinsulinemia . these results demonstrate the validity of the disposition index when relating the plasma insulin response to insulin sensitivity but underscore the pitfall of this index when drawing conclusions about - cell function , because insulin secretion declined despite an increase in the plasma insulin response .
24,937,535
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the aim of this study is to ascertain the subsequent radiobiological impact of using a consensus guideline target volume delineation atlas .", "using a representative case and target volume delineation instructions derived from a proposed imrt rectal cancer clinical trial , gross tumor volume ( gtv ) and clinical/planning target volumes ( ctv/ptv ) were contoured by @ physician observers ( phase @ ) .", "the observers were then randomly assigned to follow ( atlas ) or not-follow ( control ) a consensus guideline/atlas for anorectal cancers , and instructed to re-contour the same case ( phase @ ) .", "the atlas group was found to have increased tumor control probability ( tcp ) after the atlas intervention for both the ctv ( p < @ ) and ptv@ ( p = @ ) with decreasing normal tissue complication probability ( ntcp ) for small intestine , while the control group did not .", "additionally , the atlas group had reduced variance in tcp for all target volumes and reduced variance in ntcp for the bowel .", "in phase @ , the atlas group had increased tcp relative to the control for ctv ( p = @ ) .", "visual atlas and consensus treatment guideline usage in the development of rectal cancer imrt treatment plans reduced the inter-observer radiobiological variation , with clinically relevant tcp alteration for ctv and ptv volumes ." ]
the aim of this study is to ascertain the subsequent radiobiological impact of using a consensus guideline target volume delineation atlas . using a representative case and target volume delineation instructions derived from a proposed imrt rectal cancer clinical trial , gross tumor volume ( gtv ) and clinical/planning target volumes ( ctv/ptv ) were contoured by @ physician observers ( phase @ ) . the observers were then randomly assigned to follow ( atlas ) or not-follow ( control ) a consensus guideline/atlas for anorectal cancers , and instructed to re-contour the same case ( phase @ ) . the atlas group was found to have increased tumor control probability ( tcp ) after the atlas intervention for both the ctv ( p < @ ) and ptv@ ( p = @ ) with decreasing normal tissue complication probability ( ntcp ) for small intestine , while the control group did not . additionally , the atlas group had reduced variance in tcp for all target volumes and reduced variance in ntcp for the bowel . in phase @ , the atlas group had increased tcp relative to the control for ctv ( p = @ ) . visual atlas and consensus treatment guideline usage in the development of rectal cancer imrt treatment plans reduced the inter-observer radiobiological variation , with clinically relevant tcp alteration for ctv and ptv volumes .
24,996,454
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "this study aims to compare the clinical outcomes and costs between endoscopic biliary stenting ( ebs ) and percutaneous transhepatic biliary stenting ( ptbs ) .", "we randomly assigned @ patients with unresectable malignant biliary obstruction @ and @ to receive ebs or ptbs with self-expandable metal stent ( sems ) as palliative treatment .", "ptbs was successfully performed in @ patients who formed the ptbs group ( failed in @ patients ) .", "ebs was successfully performed in @ patients who formed the ebs group ( failed in @ patients ) .", "the effectiveness of biliary drainage , hospital stay , complications , cost , survival time and mortality were compared .", "patients in ptbs group had shorter hospital stay and lower initial and overall expense than the bbs group ( p < @ ) .", "there was no significant difference in effectiveness of biliary drainage ( p = @ ) or survival time between two groups ( p = @ ) .", "early complications occurred in ptbs group was significantly lower than in ebs group ( @/@ vs @/@ , p = @ ) .", "late complications in the ebs group did not differ significantly from ptbs group ( @/@ vs @/@ , p = @ ) .", "the survival curves in the two groups showed no significant difference ( p = @ ) .", "conclusions : @ ." ]
this study aims to compare the clinical outcomes and costs between endoscopic biliary stenting ( ebs ) and percutaneous transhepatic biliary stenting ( ptbs ) . we randomly assigned @ patients with unresectable malignant biliary obstruction @ and @ to receive ebs or ptbs with self-expandable metal stent ( sems ) as palliative treatment . ptbs was successfully performed in @ patients who formed the ptbs group ( failed in @ patients ) . ebs was successfully performed in @ patients who formed the ebs group ( failed in @ patients ) . the effectiveness of biliary drainage , hospital stay , complications , cost , survival time and mortality were compared . patients in ptbs group had shorter hospital stay and lower initial and overall expense than the bbs group ( p < @ ) . there was no significant difference in effectiveness of biliary drainage ( p = @ ) or survival time between two groups ( p = @ ) . early complications occurred in ptbs group was significantly lower than in ebs group ( @/@ vs @/@ , p = @ ) . late complications in the ebs group did not differ significantly from ptbs group ( @/@ vs @/@ , p = @ ) . the survival curves in the two groups showed no significant difference ( p = @ ) . conclusions : @ .
26,176,036
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS" ]
[ "rheumatoid arthritis ( ra ) is an inflammatory autoimmune disease in which the gut microbiota is altered .", "probiotics are microorganisms that can normalize gut microbiota ; thus , they may help to alleviate ra symptoms .", "the objective of the present clinical trial was to assess the effects of probiotic supplementation on disease activity and inflammatory cytokines in patients with ra .", "forty-six patients with ra were assigned into two groups in this randomized , double-blind , placebo-controlled clinical trial .", "the patients in the probiotic group received a daily capsule that contained a minimum of @ ( @ ) colony-forming units of lactobacillus casei @ for @ wk .", "the placebo group took capsules filled with maltodextrin for the same time period .", "questionnaires , anthropometric measurements , and fasting blood samples were collected , and the participants were assessed by a rheumatologist at baseline and at the end of the trial .", "disease activity score was significantly decreased by the intervention , and there was a significant difference between the two groups at the end of the study ( p < @ ) .", "three of the assessed serum proinflammatory cytokines ( tumor necrosis factor - , interleukin-@ , and interleukin-@ ) significantly decreased in the probiotic group ( p < @ ) ; however , serum levels of interleukin-@ were not significantly affected by the probiotic ( p = @ ) .", "the serum level of regulatory cytokine ( interleukin-@ ) was increased by the supplementation ( p < @ ) .", "the proportion of interleukin-@ to interleukin-@ was significantly increased in the probiotic group as well .", "l. casei @ supplementation improved the disease activity and inflammatory status of patients with ra .", "further studies are warranted to confirm these results , and such confirmation may lead to the introduction of probiotics as adjunctive therapy for this population ." ]
rheumatoid arthritis ( ra ) is an inflammatory autoimmune disease in which the gut microbiota is altered . probiotics are microorganisms that can normalize gut microbiota ; thus , they may help to alleviate ra symptoms . the objective of the present clinical trial was to assess the effects of probiotic supplementation on disease activity and inflammatory cytokines in patients with ra . forty-six patients with ra were assigned into two groups in this randomized , double-blind , placebo-controlled clinical trial . the patients in the probiotic group received a daily capsule that contained a minimum of @ ( @ ) colony-forming units of lactobacillus casei @ for @ wk . the placebo group took capsules filled with maltodextrin for the same time period . questionnaires , anthropometric measurements , and fasting blood samples were collected , and the participants were assessed by a rheumatologist at baseline and at the end of the trial . disease activity score was significantly decreased by the intervention , and there was a significant difference between the two groups at the end of the study ( p < @ ) . three of the assessed serum proinflammatory cytokines ( tumor necrosis factor - , interleukin-@ , and interleukin-@ ) significantly decreased in the probiotic group ( p < @ ) ; however , serum levels of interleukin-@ were not significantly affected by the probiotic ( p = @ ) . the serum level of regulatory cytokine ( interleukin-@ ) was increased by the supplementation ( p < @ ) . the proportion of interleukin-@ to interleukin-@ was significantly increased in the probiotic group as well . l. casei @ supplementation improved the disease activity and inflammatory status of patients with ra . further studies are warranted to confirm these results , and such confirmation may lead to the introduction of probiotics as adjunctive therapy for this population .
24,355,439
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "small birth size , often associated with insufficient maternal nutrition , contributes to a large share of global child undernutrition , morbidity , and mortality .", "we developed a small-quantity lipid-based nutrient supplement ( sq-lns ) to enrich the diets of pregnant women .", "the objective was to test a hypothesis that home fortification of pregnant women 's diets with sq-lns would increase birth size in an african community .", "we enrolled @ women with uncomplicated pregnancies ( < @ gestational weeks ) in a randomized controlled trial in malawi .", "the women were provided with one daily iron-folic acid ( ifa ) capsule , one capsule containing multiple micronutrients ( mmns ) , or one @-g sachet of sq-lns ( lns , containing @ kcal , protein , carbohydrates , essential fatty acids , and @ micronutrients ) .", "primary outcomes were birth weight and newborn length .", "secondary outcomes included newborn weight , head and arm circumference , and pregnancy duration .", "analysis was by intention to treat .", "the mean sd birth weight and newborn length were @ @ , @ @ , and @ @ g ( p = @ ) and @ @ , @ @ , and @ @ cm ( p = @ ) in the ifa , mmn , and lns groups , respectively .", "for newborn weight-for-age , head circumference , and arm circumference , the point estimate for the mean was also highest in the lns group , intermediate in the mmn group , and lowest in the ifa group , but except for midupper arm circumference ( p = @ ) , the differences were not statistically significant .", "the prevalence of low birth weight ( < @ g ) was @ % , @ % , and @ % ( p = @ ) , respectively ; newborn stunting ( length-for-age z score < -@ ) was @ % , @ % , and @ % ( p = @ ) , respectively ; and newborn small head circumference ( head circumference-for-age z score < -@ ) was @ % , @ % , and @ % ( p = @ ) , respectively .", "the associations between the intervention and the outcomes were not modified by maternal parity , age , or nutritional status ( p > @ ) .", "the study findings do not support a hypothesis that provision of sq-lns to all pregnant women would increase the mean birth size in rural malawi .", "the trial was registered at clinicaltrials.gov as nct@ ." ]
small birth size , often associated with insufficient maternal nutrition , contributes to a large share of global child undernutrition , morbidity , and mortality . we developed a small-quantity lipid-based nutrient supplement ( sq-lns ) to enrich the diets of pregnant women . the objective was to test a hypothesis that home fortification of pregnant women 's diets with sq-lns would increase birth size in an african community . we enrolled @ women with uncomplicated pregnancies ( < @ gestational weeks ) in a randomized controlled trial in malawi . the women were provided with one daily iron-folic acid ( ifa ) capsule , one capsule containing multiple micronutrients ( mmns ) , or one @-g sachet of sq-lns ( lns , containing @ kcal , protein , carbohydrates , essential fatty acids , and @ micronutrients ) . primary outcomes were birth weight and newborn length . secondary outcomes included newborn weight , head and arm circumference , and pregnancy duration . analysis was by intention to treat . the mean sd birth weight and newborn length were @ @ , @ @ , and @ @ g ( p = @ ) and @ @ , @ @ , and @ @ cm ( p = @ ) in the ifa , mmn , and lns groups , respectively . for newborn weight-for-age , head circumference , and arm circumference , the point estimate for the mean was also highest in the lns group , intermediate in the mmn group , and lowest in the ifa group , but except for midupper arm circumference ( p = @ ) , the differences were not statistically significant . the prevalence of low birth weight ( < @ g ) was @ % , @ % , and @ % ( p = @ ) , respectively ; newborn stunting ( length-for-age z score < -@ ) was @ % , @ % , and @ % ( p = @ ) , respectively ; and newborn small head circumference ( head circumference-for-age z score < -@ ) was @ % , @ % , and @ % ( p = @ ) , respectively . the associations between the intervention and the outcomes were not modified by maternal parity , age , or nutritional status ( p > @ ) . the study findings do not support a hypothesis that provision of sq-lns to all pregnant women would increase the mean birth size in rural malawi . the trial was registered at clinicaltrials.gov as nct@ .
25,646,337
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "obesity impairs cognition and health-related quality of life ( hrqol ) in older adults ; however , the appropriate treatment of obese older adults remains controversial .", "the objective was to determine the independent and combined effects of weight loss and exercise on cognition , mood , and hrqol in obese older adults .", "one hundred seven frail , obese older adults were randomly assigned to a control , weight-management ( diet ) , exercise , or weight-management-plus-exercise ( diet-exercise ) group for @ y.", "in this secondary analysis , main outcomes were modified mini-mental state examination ( @ms ) and total impact of weight on quality of life-lite ( iwqol ) scores .", "other outcomes included word fluency test , trail making test parts a and b , and geriatric depression scale ( gds ) scores .", "scores on the @ms improved more in the diet ( mean se : @ @ ) , exercise ( @ @ ) , and diet-exercise ( @ @ ) groups than in the control group ( @ @ ) ( between-group p = @-@ @ ) ; scores in the diet-exercise group improved more than in the diet group but not more than in the exercise group .", "scores on the word fluency test improved more in the exercise ( @ @ ) and diet-exercise ( @ @ ) groups than in the control group ( -@ @ ; both p = @ ) .", "for the trail making test part a , scores in the diet-exercise group ( -@ @ ) improved more than in the control group ( -@ @ ) ( p = @ ) ; a similar finding was observed for the trail making test part b. scores on the iwqol improved more in the diet ( @ @ ) , exercise ( @ @ ) , and diet-exercise ( @ @ ) groups than in the control group ( @ @ ) ( p = @-@ @ ) ; scores in the diet-exercise group improved more than in the diet group but not more than in the exercise group .", "in the diet-exercise group , peak oxygen consumption and strength changes were independent predictors of @ms changes ; weight and strength changes were independent predictors of iwqol changes .", "gds scores did not change .", "weight loss and exercise each improve cognition and hrqol , but their combination may provide benefits similar to exercise alone .", "these findings could inform practice guidelines with regard to optimal treatment strategies for obese older adults .", "this trial was registered atclinicaltrials.govas nct@ ." ]
obesity impairs cognition and health-related quality of life ( hrqol ) in older adults ; however , the appropriate treatment of obese older adults remains controversial . the objective was to determine the independent and combined effects of weight loss and exercise on cognition , mood , and hrqol in obese older adults . one hundred seven frail , obese older adults were randomly assigned to a control , weight-management ( diet ) , exercise , or weight-management-plus-exercise ( diet-exercise ) group for @ y. in this secondary analysis , main outcomes were modified mini-mental state examination ( @ms ) and total impact of weight on quality of life-lite ( iwqol ) scores . other outcomes included word fluency test , trail making test parts a and b , and geriatric depression scale ( gds ) scores . scores on the @ms improved more in the diet ( mean se : @ @ ) , exercise ( @ @ ) , and diet-exercise ( @ @ ) groups than in the control group ( @ @ ) ( between-group p = @-@ @ ) ; scores in the diet-exercise group improved more than in the diet group but not more than in the exercise group . scores on the word fluency test improved more in the exercise ( @ @ ) and diet-exercise ( @ @ ) groups than in the control group ( -@ @ ; both p = @ ) . for the trail making test part a , scores in the diet-exercise group ( -@ @ ) improved more than in the control group ( -@ @ ) ( p = @ ) ; a similar finding was observed for the trail making test part b. scores on the iwqol improved more in the diet ( @ @ ) , exercise ( @ @ ) , and diet-exercise ( @ @ ) groups than in the control group ( @ @ ) ( p = @-@ @ ) ; scores in the diet-exercise group improved more than in the diet group but not more than in the exercise group . in the diet-exercise group , peak oxygen consumption and strength changes were independent predictors of @ms changes ; weight and strength changes were independent predictors of iwqol changes . gds scores did not change . weight loss and exercise each improve cognition and hrqol , but their combination may provide benefits similar to exercise alone . these findings could inform practice guidelines with regard to optimal treatment strategies for obese older adults . this trial was registered atclinicaltrials.govas nct@ .
24,787,497
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the purpose of this study was to determine whether contrast-enhanced sonography can improve the ability to differentiate branch duct intraductal mucinous neoplasms from serous cystadenomas of the pancreas compared to conventional ( unenhanced ) sonography alone .", "between march @ and may @ , there were @ patients with branch duct intraductal mucinous neoplasms and @ with serous cystadenomas in our institute , for whom preoperative conventional and contrast-enhanced sonographic results were available .", "the final diagnosis was obtained by histopathology .", "various conventional and contrast-enhanced sonographic characteristics were retrospectively evaluated by @ radiologists in consensus .", "a receiver operating characteristic curve analysis was used to evaluate the diagnostic value of conventional and contrast-enhanced sonography for discriminating between the two entities .", "three conventional sonographic characteristics ( microcysts , cysts with internal echoes , and main pancreatic duct dilatation ) and @ contrast-enhanced sonographic characteristics ( communication between the lesion and main pancreatic duct and enhancement of mural nodules ) significantly improved the ability to differentiate branch duct intraductal mucinous neoplasms from serous cystadenomas .", "the area under the receiver operating characteristic curve increased from @ with conventional sonography to @ with combined contrast-enhanced and conventional ultrasonography ( p = @ ) .", "in this series of patients , the addition of contrast-enhanced sonography to conventional sonography improved the ability to differentiate branch duct intraductal mucinous neoplasms from serous cystadenomas ." ]
the purpose of this study was to determine whether contrast-enhanced sonography can improve the ability to differentiate branch duct intraductal mucinous neoplasms from serous cystadenomas of the pancreas compared to conventional ( unenhanced ) sonography alone . between march @ and may @ , there were @ patients with branch duct intraductal mucinous neoplasms and @ with serous cystadenomas in our institute , for whom preoperative conventional and contrast-enhanced sonographic results were available . the final diagnosis was obtained by histopathology . various conventional and contrast-enhanced sonographic characteristics were retrospectively evaluated by @ radiologists in consensus . a receiver operating characteristic curve analysis was used to evaluate the diagnostic value of conventional and contrast-enhanced sonography for discriminating between the two entities . three conventional sonographic characteristics ( microcysts , cysts with internal echoes , and main pancreatic duct dilatation ) and @ contrast-enhanced sonographic characteristics ( communication between the lesion and main pancreatic duct and enhancement of mural nodules ) significantly improved the ability to differentiate branch duct intraductal mucinous neoplasms from serous cystadenomas . the area under the receiver operating characteristic curve increased from @ with conventional sonography to @ with combined contrast-enhanced and conventional ultrasonography ( p = @ ) . in this series of patients , the addition of contrast-enhanced sonography to conventional sonography improved the ability to differentiate branch duct intraductal mucinous neoplasms from serous cystadenomas .
24,567,456
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to test the hypothesis that an initial fraction of inspired oxygen ( fio@ ) of @ % during resuscitation of preterm infants results in less oxidative stress and is associated with improved clinical outcomes compared with an fio@ of @ % .", "preterm infants of gestational age < @ weeks ( n = @ ) were randomized to start resuscitation with either @ % oxygen ( low-oxygen group ) or @ % oxygen ( high-oxygen group ) , after which the fio@ was adjusted based on oxygen saturation values .", "the primary outcome was bronchopulmonary dysplasia ( bpd ) assessed at @ weeks postmenstrual age .", "secondary outcomes included major neonatal illnesses and markers of oxidative stress .", "the median gestational age of included infants was @ ( @ ) / @ weeks ( iqr , @ ( @ ) / @-@ ( @ ) / @ weeks ) .", "the incidence of bpd was not significantly different between the low-oxygen and high-oxygen groups ( @ % vs. @ % ; p = @ ) .", "the fio@ in both groups was adjusted to a mean of @ % by @ minutes in the low-oxygen group and by @ minutes in the high-oxygen group .", "no differences in markers of oxidative stress were noted between groups .", "initial supplementation of preterm infants with @ % oxygen during the fetal-to-neonatal transition is as safe as @ % oxygen , with no differences in oxidative stress markers or bpd ." ]
to test the hypothesis that an initial fraction of inspired oxygen ( fio@ ) of @ % during resuscitation of preterm infants results in less oxidative stress and is associated with improved clinical outcomes compared with an fio@ of @ % . preterm infants of gestational age < @ weeks ( n = @ ) were randomized to start resuscitation with either @ % oxygen ( low-oxygen group ) or @ % oxygen ( high-oxygen group ) , after which the fio@ was adjusted based on oxygen saturation values . the primary outcome was bronchopulmonary dysplasia ( bpd ) assessed at @ weeks postmenstrual age . secondary outcomes included major neonatal illnesses and markers of oxidative stress . the median gestational age of included infants was @ ( @ ) / @ weeks ( iqr , @ ( @ ) / @-@ ( @ ) / @ weeks ) . the incidence of bpd was not significantly different between the low-oxygen and high-oxygen groups ( @ % vs. @ % ; p = @ ) . the fio@ in both groups was adjusted to a mean of @ % by @ minutes in the low-oxygen group and by @ minutes in the high-oxygen group . no differences in markers of oxidative stress were noted between groups . initial supplementation of preterm infants with @ % oxygen during the fetal-to-neonatal transition is as safe as @ % oxygen , with no differences in oxidative stress markers or bpd .
24,655,537
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to compare immediate surgery to scaling and root planing ( srp ) in the treatment of advanced periodontal disease focusing on the prevalence of residual sites and cost-effectiveness ( @ ) ; to evaluate the adjunctive effects of azithromycin in a second treatment phase ( @ ) .", "thirty-nine patients ( @ males , @ females ; mean age : @ ) received oral hygiene instructions and were randomly allocated to surgery ( n = @ ) or srp ( n = @ ) .", "patients with residual pockets ( @mm ) at @months received re-debridement of these sites and systemic azithromycin .", "treatment groups were followed up to @months and evaluated in terms of clinical response parameters and cost-effectiveness .", "chair-time was used to assess the financial impact of treatment .", "both treatment arms were equally effective in terms of clinical outcome demonstrating less than @ % residual pockets at @months .", "surgery imposed an extra @ euro on the patient up to @months when compared to srp .", "at @months , @ euro of this amount could be offset as a result of a reduced need for supportive care .", "only @ patients in the surgery group needed systemic antibiotics , whereas @ patients in the srp needed such additional treatment .", "although @ euro could be saved on average by performing srp instead of surgery , the latter significantly reduced the need for supportive care and systemic antibiotics ." ]
to compare immediate surgery to scaling and root planing ( srp ) in the treatment of advanced periodontal disease focusing on the prevalence of residual sites and cost-effectiveness ( @ ) ; to evaluate the adjunctive effects of azithromycin in a second treatment phase ( @ ) . thirty-nine patients ( @ males , @ females ; mean age : @ ) received oral hygiene instructions and were randomly allocated to surgery ( n = @ ) or srp ( n = @ ) . patients with residual pockets ( @mm ) at @months received re-debridement of these sites and systemic azithromycin . treatment groups were followed up to @months and evaluated in terms of clinical response parameters and cost-effectiveness . chair-time was used to assess the financial impact of treatment . both treatment arms were equally effective in terms of clinical outcome demonstrating less than @ % residual pockets at @months . surgery imposed an extra @ euro on the patient up to @months when compared to srp . at @months , @ euro of this amount could be offset as a result of a reduced need for supportive care . only @ patients in the surgery group needed systemic antibiotics , whereas @ patients in the srp needed such additional treatment . although @ euro could be saved on average by performing srp instead of surgery , the latter significantly reduced the need for supportive care and systemic antibiotics .
24,256,079
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "elective interval appendectomy ( ia ) is traditionally advocated for the management of appendiceal mass ( am ) in children .", "surgeons have debated the evidence and ` risks ' vs. ` benefits ' to support ia .", "there are currently no randomised controlled trials and guiding best practice and financial costings for ia are lacking .", "we herein report clinical outcomes , patient benefits and tariff charges linked with the provision of ia at a regional uk paediatric surgical centre .", "hospital case records of patients with am were identified using pathology records and hospital admission codes during a @-year period ( @-@ ) .", "tariff costs ( sterling ) were calculated for all admissions during the era @-@ .", "@ children were admitted with am ( @ % female , median age @ years , range @-@ years ) .", "median initial hospital stay with resolution of symptoms was @ days ( range @-@ days ) .", "@ children ( @ % ) had elective ia ( median interval @ days , range @-@ days ) .", "eight ( @ % ) patients required emergency readmission for early appendectomy ( median interval @ days , range @-@ days ) .", "hospital stay for emergency readmission appendectomy in these children was significantly longer than ia ( median @ vs. @ days , p < @ ) .", "laparoscopic appendectomy vs. ` open ' appendectomy was associated with shorter length of stay in the ia cohort ( median @ vs. @ days p < @ ) .", "no intra-operative morbidity was recorded in the study with only a single case developing a post-operative wound infection .", "median cost for ia was @,@ .", "costings were higher in the emergency appendectomy group-@ ,@ vs. @,@ ; p = @ , ns .", "only @ % of children at this centre develop recurrent appendicitis after primary admission with am .", "interval and emergency appendectomy were associated with low morbidity .", "parents should be informed that ia may be ` non essential ' surgery .", "paediatric surgeons not routinely advocating ia can potentially save the nhs @,@ per patient .", "future randomised studies are warranted to confirm or refute these findings ." ]
elective interval appendectomy ( ia ) is traditionally advocated for the management of appendiceal mass ( am ) in children . surgeons have debated the evidence and ` risks ' vs. ` benefits ' to support ia . there are currently no randomised controlled trials and guiding best practice and financial costings for ia are lacking . we herein report clinical outcomes , patient benefits and tariff charges linked with the provision of ia at a regional uk paediatric surgical centre . hospital case records of patients with am were identified using pathology records and hospital admission codes during a @-year period ( @-@ ) . tariff costs ( sterling ) were calculated for all admissions during the era @-@ . @ children were admitted with am ( @ % female , median age @ years , range @-@ years ) . median initial hospital stay with resolution of symptoms was @ days ( range @-@ days ) . @ children ( @ % ) had elective ia ( median interval @ days , range @-@ days ) . eight ( @ % ) patients required emergency readmission for early appendectomy ( median interval @ days , range @-@ days ) . hospital stay for emergency readmission appendectomy in these children was significantly longer than ia ( median @ vs. @ days , p < @ ) . laparoscopic appendectomy vs. ` open ' appendectomy was associated with shorter length of stay in the ia cohort ( median @ vs. @ days p < @ ) . no intra-operative morbidity was recorded in the study with only a single case developing a post-operative wound infection . median cost for ia was @,@ . costings were higher in the emergency appendectomy group-@ ,@ vs. @,@ ; p = @ , ns . only @ % of children at this centre develop recurrent appendicitis after primary admission with am . interval and emergency appendectomy were associated with low morbidity . parents should be informed that ia may be ` non essential ' surgery . paediatric surgeons not routinely advocating ia can potentially save the nhs @,@ per patient . future randomised studies are warranted to confirm or refute these findings .
24,874,344
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "this in situ study assessed the effects of adhesive systems containing or not fluoride and/or the antibacterial monomer @-methacryloyloxydodecylpyridinium bromide ( mdpb ) on the microbiological composition of dental biofilm and enamel demineralization .", "during two phases of @ days , ten volunteers wore intraoral palatal appliances containing two slabs of human enamel according to a double-blind , crossover design .", "the slabs were randomly restored using a composite resin and one of the following adhesive systems : all-bond se ( tm ) ( self-etch , fluoride/mdpb free adhesive , ab ) and clearfl protect bond ( self-etch containing fluoride and mdpb adhesive , cb ) .", "the biofilm formed on the slabs was analyzed with regard to total and mutans streptococci and lactobacilli counts .", "demineralization represented by integrated area of hardness lesion depth delta s ( s ) was determined on enamel by analysis of cross-sectional microhardness , at @ and @ m from the restoration margin .", "data were analyzed by anova .", "no statistically significant difference was found either in enamel demineralization or in the microbiological composition of dental biofilm .", "all adhesive systems containing or not fluoride and/or mdpb tested were unable to inhibit secondary caries in the in situ model used in the present research ." ]
this in situ study assessed the effects of adhesive systems containing or not fluoride and/or the antibacterial monomer @-methacryloyloxydodecylpyridinium bromide ( mdpb ) on the microbiological composition of dental biofilm and enamel demineralization . during two phases of @ days , ten volunteers wore intraoral palatal appliances containing two slabs of human enamel according to a double-blind , crossover design . the slabs were randomly restored using a composite resin and one of the following adhesive systems : all-bond se ( tm ) ( self-etch , fluoride/mdpb free adhesive , ab ) and clearfl protect bond ( self-etch containing fluoride and mdpb adhesive , cb ) . the biofilm formed on the slabs was analyzed with regard to total and mutans streptococci and lactobacilli counts . demineralization represented by integrated area of hardness lesion depth delta s ( s ) was determined on enamel by analysis of cross-sectional microhardness , at @ and @ m from the restoration margin . data were analyzed by anova . no statistically significant difference was found either in enamel demineralization or in the microbiological composition of dental biofilm . all adhesive systems containing or not fluoride and/or mdpb tested were unable to inhibit secondary caries in the in situ model used in the present research .
25,095,833
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS" ]
[ "this pilot study compared the effects of lexical-semantic stimulation through telecommunication technology ( lss-tele ) with in-person lss ( lss-direct ) and unstructured cognitive treatment ( ucs ) in patients with early alzheimer 's disease .", "twenty-seven patients with alzheimer 's disease in the very early stage ( mini-mental state examination -lsb- mmse -rsb- > @/@ ) were divided into three groups : seven patients received lss-tele treatment , ten received standard lss-direct intervention , and ten participants underwent ucs as control condition .", "intervention treatments consisted of two weekly sessions of lss ( through teleconference or face to face depending on group assignment ) or ucs exercises administered to small groups throughout a @-month period .", "the main outcome measures were changes of global cognitive performance , language abilities , and memory function .", "secondary outcome measures were changes in attention , working memory , executive functions , and visual-spatial abilities tests .", "the mean mmse score improved significantly in lss-tele and lss-direct treatments ; lss-tele improved language abilities , both phonemic and semantic , and stabilized delayed verbal episodic memory with respect to an improved performance after the lss-direct intervention and to a memory decline observed in the control group .", "improvement was not achieved in any neuropsychological test score after ucs .", "clinical application of telecommunication technology to cognitive rehabilitation of elderly patients with neurodegenerative cognitive impairment is feasible and may improve global cognitive performance .", "technical aspects to ameliorate efficacy of delivery may further improve its impact on domain-specific cognitive abilities ." ]
this pilot study compared the effects of lexical-semantic stimulation through telecommunication technology ( lss-tele ) with in-person lss ( lss-direct ) and unstructured cognitive treatment ( ucs ) in patients with early alzheimer 's disease . twenty-seven patients with alzheimer 's disease in the very early stage ( mini-mental state examination -lsb- mmse -rsb- > @/@ ) were divided into three groups : seven patients received lss-tele treatment , ten received standard lss-direct intervention , and ten participants underwent ucs as control condition . intervention treatments consisted of two weekly sessions of lss ( through teleconference or face to face depending on group assignment ) or ucs exercises administered to small groups throughout a @-month period . the main outcome measures were changes of global cognitive performance , language abilities , and memory function . secondary outcome measures were changes in attention , working memory , executive functions , and visual-spatial abilities tests . the mean mmse score improved significantly in lss-tele and lss-direct treatments ; lss-tele improved language abilities , both phonemic and semantic , and stabilized delayed verbal episodic memory with respect to an improved performance after the lss-direct intervention and to a memory decline observed in the control group . improvement was not achieved in any neuropsychological test score after ucs . clinical application of telecommunication technology to cognitive rehabilitation of elderly patients with neurodegenerative cognitive impairment is feasible and may improve global cognitive performance . technical aspects to ameliorate efficacy of delivery may further improve its impact on domain-specific cognitive abilities .
25,284,993
[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "activation of trpm@ and trpa@ receptors generates cold and cold pain sensations , respectively , and is presumably important in clinical pain manifestations , such as cold hyperalgesia .", "this study investigated the interaction between trpm@ and trpa@ receptors through stimulation of glabrous human skin ( volar forearm ) by topical administration of @ % l-menthol and @ % trans-cinnamaldehyde ( ca ) , individually and in combination .", "sensory manifestations were assessed in @ healthy volunteers via a platform of @ quantitative sensory ( thermal and mechanical stimuli ) and vasomotor tests ( skin temperature , perfusion and axon-reflex-flare ) in a double-blinded randomized crossover design .", "cold pain threshold was increased ( p < @ , cold allodynia ) by l-menthol alone and l-menthol + ca in combination but unaffected by ca .", "mechanical pain threshold was significantly decreased ( mechanical hyperalgesia ) by all three substances ( p < @ ) , with a significant intergroup difference found between ca alone and the less decreased l-menthol + ca ( p < @ ) .", "application of ca alone and l-menthol + ca in combination showed an increase in skin temperature and perfusion significantly larger than that induced by l-menthol alone ( p < @ ) .", "an axon-reflex-flare was present after ca administration , but was significantly reduced upon addition of l-menthol ( p < @ ) .", "this study elucidates the potential of l-menthol as a counter-irritant to secondary neurogenic inflammation and provides evidence of an intricate interplay between cold receptors trpa@ and trpm@ , warranting further investigation of the neural coding of cold pain perception ." ]
activation of trpm@ and trpa@ receptors generates cold and cold pain sensations , respectively , and is presumably important in clinical pain manifestations , such as cold hyperalgesia . this study investigated the interaction between trpm@ and trpa@ receptors through stimulation of glabrous human skin ( volar forearm ) by topical administration of @ % l-menthol and @ % trans-cinnamaldehyde ( ca ) , individually and in combination . sensory manifestations were assessed in @ healthy volunteers via a platform of @ quantitative sensory ( thermal and mechanical stimuli ) and vasomotor tests ( skin temperature , perfusion and axon-reflex-flare ) in a double-blinded randomized crossover design . cold pain threshold was increased ( p < @ , cold allodynia ) by l-menthol alone and l-menthol + ca in combination but unaffected by ca . mechanical pain threshold was significantly decreased ( mechanical hyperalgesia ) by all three substances ( p < @ ) , with a significant intergroup difference found between ca alone and the less decreased l-menthol + ca ( p < @ ) . application of ca alone and l-menthol + ca in combination showed an increase in skin temperature and perfusion significantly larger than that induced by l-menthol alone ( p < @ ) . an axon-reflex-flare was present after ca administration , but was significantly reduced upon addition of l-menthol ( p < @ ) . this study elucidates the potential of l-menthol as a counter-irritant to secondary neurogenic inflammation and provides evidence of an intricate interplay between cold receptors trpa@ and trpm@ , warranting further investigation of the neural coding of cold pain perception .
24,664,788
[ "BACKGROUND", "BACKGROUND", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the placement of aortic transcatheter valves ( partner ) trial reported a reduced rate of mortality in patients with previous coronary bypass grafting ( cabg ) operation who received surgical aortic valve replacement ( savr ) in comparison with transcatheter aortic valve replacement ( tavr ) .", "we sought to further evaluate these groups .", "we reviewed the database of the @ patients enrolled in the partner trial .", "the cohort for this study consisted of @ patients ( @ % ) who had a history of cabg operation before enrollment in the partner trial .", "all patients were followed up for @ years .", "the mean age was @ years , and @ patients ( @ % ) were men .", "the preoperative characteristics were similar in @ patients ( @ % ) who received savr and @ ( @ % ) who received tavr .", "there were no differences between the two groups with respect to the operative outcomes of death , stroke , and myocardial infarction , but the tavr patients experienced more paravalvular regurgitation ( p < @ ) .", "at @ years , there was a trend toward greater all-cause mortality in the tavr patients ( hazard ratio -lsb- hr -rsb- @ ; @ % confidence interval -lsb- ci -rsb- : @ , @ ; p = @ ) .", "furthermore , the tavr patients had more repeated hospitalization ( hr @ ; @ % ci : @ , @ ; p = @ ) , death of any cause or repeated hospitalization ( hr @ ; @ % ci : @ , @ ; p = @ ) , and death of any cause or stroke ( hr @ ; @ % ci : @ , @ ; p = @ ) .", "the @-year follow-up of patients with a history of previous cabg operation in the partner trial demonstrated improved outcomes with savr in comparison with tavr .", "further longitudinal assessment is necessary to corroborate these findings and to understand the possible causes ." ]
the placement of aortic transcatheter valves ( partner ) trial reported a reduced rate of mortality in patients with previous coronary bypass grafting ( cabg ) operation who received surgical aortic valve replacement ( savr ) in comparison with transcatheter aortic valve replacement ( tavr ) . we sought to further evaluate these groups . we reviewed the database of the @ patients enrolled in the partner trial . the cohort for this study consisted of @ patients ( @ % ) who had a history of cabg operation before enrollment in the partner trial . all patients were followed up for @ years . the mean age was @ years , and @ patients ( @ % ) were men . the preoperative characteristics were similar in @ patients ( @ % ) who received savr and @ ( @ % ) who received tavr . there were no differences between the two groups with respect to the operative outcomes of death , stroke , and myocardial infarction , but the tavr patients experienced more paravalvular regurgitation ( p < @ ) . at @ years , there was a trend toward greater all-cause mortality in the tavr patients ( hazard ratio -lsb- hr -rsb- @ ; @ % confidence interval -lsb- ci -rsb- : @ , @ ; p = @ ) . furthermore , the tavr patients had more repeated hospitalization ( hr @ ; @ % ci : @ , @ ; p = @ ) , death of any cause or repeated hospitalization ( hr @ ; @ % ci : @ , @ ; p = @ ) , and death of any cause or stroke ( hr @ ; @ % ci : @ , @ ; p = @ ) . the @-year follow-up of patients with a history of previous cabg operation in the partner trial demonstrated improved outcomes with savr in comparison with tavr . further longitudinal assessment is necessary to corroborate these findings and to understand the possible causes .
24,881,859
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to determine influenza ( flu ) vaccination status among the mentally ill population and identify factors associated with vaccination status .", "a non-interventional , cross-sectional study was conducted .", "a self-administered survey to investigate the vaccination status and perceptions related to flu vaccine was administered between october @-january @ in an outpatient psychiatry clinic that served the indigent , severely mentally ill population of alabama .", "all statistical analyses were based upon a significance level of @ .", "of the @ patients invited , @ participated ( @ % ) .", "only @ % were vaccinated in @-@ and @ % had been vaccinated at the time of the survey for @-@ .", "respondents who had private health insurance , received a recommendation from healthcare providers , and who perceived a greater degree of vaccine effectiveness were more likely to obtain flu vaccination while respondents who had education beyond high school and were more in agreement that they can get the flu from the vaccine were less likely to obtain flu vaccination .", "all of the above factors accounted for @ % of vaccination decisions .", "the flu vaccination rate among this study 's population was lower than the general population .", "interventions targeting the above factors should help increase vaccination rates among the mentally ill population ." ]
to determine influenza ( flu ) vaccination status among the mentally ill population and identify factors associated with vaccination status . a non-interventional , cross-sectional study was conducted . a self-administered survey to investigate the vaccination status and perceptions related to flu vaccine was administered between october @-january @ in an outpatient psychiatry clinic that served the indigent , severely mentally ill population of alabama . all statistical analyses were based upon a significance level of @ . of the @ patients invited , @ participated ( @ % ) . only @ % were vaccinated in @-@ and @ % had been vaccinated at the time of the survey for @-@ . respondents who had private health insurance , received a recommendation from healthcare providers , and who perceived a greater degree of vaccine effectiveness were more likely to obtain flu vaccination while respondents who had education beyond high school and were more in agreement that they can get the flu from the vaccine were less likely to obtain flu vaccination . all of the above factors accounted for @ % of vaccination decisions . the flu vaccination rate among this study 's population was lower than the general population . interventions targeting the above factors should help increase vaccination rates among the mentally ill population .
24,547,606
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to compare two embryo grouping strategies .", "retrospective time-course analysis in two different centres .", "two culture protocols were used at the zygote stage : `` random group '' in which zygotes were randomly grouped and `` definite group '' in which zygotes were grouped based on pronuclear pattern .", "embryo culture was extended to blastocyst stage .", "primary and secondary outcomes were respectively the blastulation rate and the cumulative clinical pregnancy and implantation rates .", "a similar blastulation rate -lsb- @ and @ % day ( @ +@ ) blastocysts -rsb- was obtained in the two groups .", "conversely , after adjusting for baseline and cycle variables , cumulative pregnancy -lsb- adjusted odds ratio = @ ( @ % ci : @-@ @ ) -rsb- and implantation -lsb- adjusted odds ratio = @ ( @ % ci : @-@ @ ) -rsb- rates were significantly higher in the `` random group '' compared to the `` definite group '' .", "two strategies of group culture gave similar results in terms of blastulation rate but the random grouping of zygotes improves pregnancy and implantation rates in ivf-cycles ." ]
to compare two embryo grouping strategies . retrospective time-course analysis in two different centres . two culture protocols were used at the zygote stage : `` random group '' in which zygotes were randomly grouped and `` definite group '' in which zygotes were grouped based on pronuclear pattern . embryo culture was extended to blastocyst stage . primary and secondary outcomes were respectively the blastulation rate and the cumulative clinical pregnancy and implantation rates . a similar blastulation rate -lsb- @ and @ % day ( @ +@ ) blastocysts -rsb- was obtained in the two groups . conversely , after adjusting for baseline and cycle variables , cumulative pregnancy -lsb- adjusted odds ratio = @ ( @ % ci : @-@ @ ) -rsb- and implantation -lsb- adjusted odds ratio = @ ( @ % ci : @-@ @ ) -rsb- rates were significantly higher in the `` random group '' compared to the `` definite group '' . two strategies of group culture gave similar results in terms of blastulation rate but the random grouping of zygotes improves pregnancy and implantation rates in ivf-cycles .
25,261,353
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "endogenous pain modulation has been studied with the conditioned pain modulation ( cpm ) paradigm with large differences in the magnitude of the cpm effect .", "we hypothesized that differences in cpm effects might be associated with differences in blood pressure responses to the conditioning stimulus when comparing the cpm effects using two different conditioning stimuli .", "a single-blind repeated-measures design with block-randomization was applied on @ healthy male subjects .", "the test stimulus ( ts ; tonic heat pain for @s ) was first presented alone , thereafter in parallel with a conditioning stimulus ( cs ) .", "conditioning stimuli were either a cold pressor test ( cpt ) or equally painful ischaemic muscle pain ( isc ) , both lasting @s .", "finger blood pressure and heart rate were recorded continuously .", "data were analysed in a linear mixed model framework with cs type ( cpt or isc ) and conditioning ( ts or ts+cs ) as independent factors .", "an inhibitory cpm effect was found for both types of conditioning ( p < @ ) .", "the cpm effect was larger during cpt conditioning compared with isc conditioning ( p = @ ) .", "no association with the concomitant cardiovascular response ( blood pressure and heart rate ) was found ( p > @ ) .", "cold pressor pain cs induces larger cpm effects than ischaemic pain cs .", "the larger cpm effect is , however , not associated with a larger blood pressure response .", "other factors related to the cs should be investigated to understand why different cs modalities give different cpm effects ." ]
endogenous pain modulation has been studied with the conditioned pain modulation ( cpm ) paradigm with large differences in the magnitude of the cpm effect . we hypothesized that differences in cpm effects might be associated with differences in blood pressure responses to the conditioning stimulus when comparing the cpm effects using two different conditioning stimuli . a single-blind repeated-measures design with block-randomization was applied on @ healthy male subjects . the test stimulus ( ts ; tonic heat pain for @s ) was first presented alone , thereafter in parallel with a conditioning stimulus ( cs ) . conditioning stimuli were either a cold pressor test ( cpt ) or equally painful ischaemic muscle pain ( isc ) , both lasting @s . finger blood pressure and heart rate were recorded continuously . data were analysed in a linear mixed model framework with cs type ( cpt or isc ) and conditioning ( ts or ts+cs ) as independent factors . an inhibitory cpm effect was found for both types of conditioning ( p < @ ) . the cpm effect was larger during cpt conditioning compared with isc conditioning ( p = @ ) . no association with the concomitant cardiovascular response ( blood pressure and heart rate ) was found ( p > @ ) . cold pressor pain cs induces larger cpm effects than ischaemic pain cs . the larger cpm effect is , however , not associated with a larger blood pressure response . other factors related to the cs should be investigated to understand why different cs modalities give different cpm effects .
24,677,417
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "a principal justification for the use of high-fidelity ( hf ) simulation is that , because it is closer to reality , students will be more motivated to learn and , consequently , will be better able to transfer their learning to real patients .", "however , the increased authenticity is accompanied by greater complexity , which may reduce learning , and variability in the presentation of a condition on an hf simulator is typically restricted .", "this study was conducted to explore the effectiveness of hf and low-fidelity ( lf ) simulation for learning within the clinical education and practice domains of cardiac and respiratory auscultation and physical assessment skills .", "senior-level nursing students were randomised to hf and lf instruction groups or to a control group .", "primary outcome measures included lf ( digital sounds on a computer ) and hf ( human patient simulator ) auscultation tests of cardiac and respiratory sounds , as well as observer-rated performances in simulated clinical scenarios .", "on the lf auscultation test , the lf group consistently demonstrated performance comparable or superior to that of the hf group , and both were superior to the performance of the control group .", "for both hf outcome measures , there was no significant difference in performance between the hf and lf instruction groups .", "the results from this study suggest that highly contextualised learning environments may not be uniformly advantageous for instruction and may lead to ineffective learning by increasing extraneous cognitive load in novice learners ." ]
a principal justification for the use of high-fidelity ( hf ) simulation is that , because it is closer to reality , students will be more motivated to learn and , consequently , will be better able to transfer their learning to real patients . however , the increased authenticity is accompanied by greater complexity , which may reduce learning , and variability in the presentation of a condition on an hf simulator is typically restricted . this study was conducted to explore the effectiveness of hf and low-fidelity ( lf ) simulation for learning within the clinical education and practice domains of cardiac and respiratory auscultation and physical assessment skills . senior-level nursing students were randomised to hf and lf instruction groups or to a control group . primary outcome measures included lf ( digital sounds on a computer ) and hf ( human patient simulator ) auscultation tests of cardiac and respiratory sounds , as well as observer-rated performances in simulated clinical scenarios . on the lf auscultation test , the lf group consistently demonstrated performance comparable or superior to that of the hf group , and both were superior to the performance of the control group . for both hf outcome measures , there was no significant difference in performance between the hf and lf instruction groups . the results from this study suggest that highly contextualised learning environments may not be uniformly advantageous for instruction and may lead to ineffective learning by increasing extraneous cognitive load in novice learners .
25,693,987
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "research in acute illness often requires an exception from informed consent .", "few studies have assessed the views of patients enrolled in exception from informed consent trials .", "this study was designed to assess the views of patients and their surrogates of exception from informed consent enrollment within the context of a randomized , placebo-controlled trial of an investigational agent for traumatic brain injury .", "interactive interview study .", "nested within the progesterone for the treatment of traumatic brain injury trial , a phase iii randomized controlled trial in acute traumatic brain injury .", "patients and surrogates ( for patients incapable of being interviewed ) enrolled in progesterone for the treatment of traumatic brain injury under exception from informed consent at @ sites .", "none .", "interviews focused on respondents ' acceptance of exception from informed consent enrollment in progesterone for the treatment of traumatic brain injury , use of placebo and randomization , understanding of major study elements , and views regarding regulatory protections .", "descriptive statistical analysis was performed ; textual data were analyzed thematically .", "eighty-five individuals were interviewed .", "eighty-four percent had positive attitudes toward progesterone for the treatment of traumatic brain injury inclusion .", "seventy-eight percent found their inclusion under exception from informed consent acceptable , and @ % found use of exception from informed consent in progesterone for the treatment of traumatic brain injury acceptable in general .", "only two respondents clearly disagreed with both personal and general exception from informed consent enrollment .", "the most common concerns ( @ % ) related to absence of consent .", "eighty percent and @ % were accepting of placebo use and randomization , respectively .", "although there were few black respondents ( n = @ ) , they were less accepting of personal exception from informed consent enrollment than white respondents ( @ % vs @ % ; p = @ ) .", "acceptance of exception from informed consent in this placebo-controlled trial of an investigational agent was high and exceeded acceptance among community consultation participants .", "exception from informed consent enrollment appears generally consistent with patients ' preferences ." ]
research in acute illness often requires an exception from informed consent . few studies have assessed the views of patients enrolled in exception from informed consent trials . this study was designed to assess the views of patients and their surrogates of exception from informed consent enrollment within the context of a randomized , placebo-controlled trial of an investigational agent for traumatic brain injury . interactive interview study . nested within the progesterone for the treatment of traumatic brain injury trial , a phase iii randomized controlled trial in acute traumatic brain injury . patients and surrogates ( for patients incapable of being interviewed ) enrolled in progesterone for the treatment of traumatic brain injury under exception from informed consent at @ sites . none . interviews focused on respondents ' acceptance of exception from informed consent enrollment in progesterone for the treatment of traumatic brain injury , use of placebo and randomization , understanding of major study elements , and views regarding regulatory protections . descriptive statistical analysis was performed ; textual data were analyzed thematically . eighty-five individuals were interviewed . eighty-four percent had positive attitudes toward progesterone for the treatment of traumatic brain injury inclusion . seventy-eight percent found their inclusion under exception from informed consent acceptable , and @ % found use of exception from informed consent in progesterone for the treatment of traumatic brain injury acceptable in general . only two respondents clearly disagreed with both personal and general exception from informed consent enrollment . the most common concerns ( @ % ) related to absence of consent . eighty percent and @ % were accepting of placebo use and randomization , respectively . although there were few black respondents ( n = @ ) , they were less accepting of personal exception from informed consent enrollment than white respondents ( @ % vs @ % ; p = @ ) . acceptance of exception from informed consent in this placebo-controlled trial of an investigational agent was high and exceeded acceptance among community consultation participants . exception from informed consent enrollment appears generally consistent with patients ' preferences .
25,574,795
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "fluoroscopy is the routine method for localizing left ventricular ( lv ) and right ventricular ( rv ) lead positions in cardiac resynchronization therapy ( crt ) .", "however , the ability of fluoroscopy to determine lead positions in a standard ventricular segmentation is unknown .", "we aimed to evaluate the accuracy and reproducibility of fluoroscopy to determine lv and rv lead positions in crt when compared with cardiac computed tomography ( ct ) .", "fifty-nine patients undergoing crt were included .", "bi-plane fluoroscopy and cardiac ct were evaluated in all patients .", "pacing lead positions were assessed in a standard lv @-segment model and in a simplistic rv @-segment model .", "four patients with lv lead displacement were excluded from the agreement analysis of lv lead position .", "agreement of lv lead position between fluoroscopy and cardiac ct was observed in @ ( @ % ) patients with fluoroscopy demonstrating a @-segment and @-segment error in @ ( @ % ) and @ ( @ % ) patients , respectively .", "agreement of rv lead position was found in @ ( @ % ) patients with fluoroscopy showing a @-segment and @-segment error in @ ( @ % ) and @ ( @ % ) patients , respectively .", "the interobserver agreement on lv and rv lead positions was poor for fluoroscopy ( kappa @ and @ , respectively ) and excellent for cardiac ct ( kappa @ and @ , respectively ) .", "fluoroscopy is inaccurate and modestly reproducible when assessing lv and rv lead positions in a standard ventricular segmentation when compared with cardiac ct. .", "cardiac ct should be applied to determine the exact pacing site in future research evaluating the optimal pacing lead position in crt ." ]
fluoroscopy is the routine method for localizing left ventricular ( lv ) and right ventricular ( rv ) lead positions in cardiac resynchronization therapy ( crt ) . however , the ability of fluoroscopy to determine lead positions in a standard ventricular segmentation is unknown . we aimed to evaluate the accuracy and reproducibility of fluoroscopy to determine lv and rv lead positions in crt when compared with cardiac computed tomography ( ct ) . fifty-nine patients undergoing crt were included . bi-plane fluoroscopy and cardiac ct were evaluated in all patients . pacing lead positions were assessed in a standard lv @-segment model and in a simplistic rv @-segment model . four patients with lv lead displacement were excluded from the agreement analysis of lv lead position . agreement of lv lead position between fluoroscopy and cardiac ct was observed in @ ( @ % ) patients with fluoroscopy demonstrating a @-segment and @-segment error in @ ( @ % ) and @ ( @ % ) patients , respectively . agreement of rv lead position was found in @ ( @ % ) patients with fluoroscopy showing a @-segment and @-segment error in @ ( @ % ) and @ ( @ % ) patients , respectively . the interobserver agreement on lv and rv lead positions was poor for fluoroscopy ( kappa @ and @ , respectively ) and excellent for cardiac ct ( kappa @ and @ , respectively ) . fluoroscopy is inaccurate and modestly reproducible when assessing lv and rv lead positions in a standard ventricular segmentation when compared with cardiac ct. . cardiac ct should be applied to determine the exact pacing site in future research evaluating the optimal pacing lead position in crt .
24,687,965
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to observe the safety and efficacy of early oral enteral nutrition after colorectal cancer operation .", "a total of @ colorectal cancer patients in our department from march @ to december @ were prospectively enrolled in the study and randomly divided into early enteral nutrition group ( @ cases , receiving early water and enteral nutrition after operation ) and early fasting group ( @ cases , receiving conventional postoperative care protocol ) based on the random number table .", "the postoperative recovery , complication morbidity , nutritional status and stress were compared between the two groups .", "compared to early fasting group , patients in early enteral nutrition group had a significantly shorter duration of postoperative fever -lsb- ( @ ) h vs. ( @ ) h , p < @ -rsb- , a shorter interval to flatus -lsb- ( @ ) h vs. ( @ ) h , p < @ -rsb- , a shorter hospital stay -lsb- ( @ ) d vs. ( @ ) d , p < @ -rsb- and lower medical cost -lsb- ( @@ ) yuan vs. ( @@ ) yuan , p < @ -rsb- .", "there was no significant difference in complication morbidity between the two groups -lsb- @ % ( @/@ ) vs. @ % ( @/@ ) , p > @ -rsb- .", "the albumin , prealbumin , and retinol binding protein on the third and seventh postoperative days were significantly higher in early oral enteral nutrition group ( p < @ ) , while the rest energy expense ( ree ) and lnhoma-ir were significantly lower as compared to early fasting group ( all p < @ ) .", "early oral enteral nutrition after colorectal cancer operation is safe and effective , which is a natural route of nutrition and can reduce the stress response related to surgery , improve postoperative patients ' nutritional status and accelerate rehabilitation ." ]
to observe the safety and efficacy of early oral enteral nutrition after colorectal cancer operation . a total of @ colorectal cancer patients in our department from march @ to december @ were prospectively enrolled in the study and randomly divided into early enteral nutrition group ( @ cases , receiving early water and enteral nutrition after operation ) and early fasting group ( @ cases , receiving conventional postoperative care protocol ) based on the random number table . the postoperative recovery , complication morbidity , nutritional status and stress were compared between the two groups . compared to early fasting group , patients in early enteral nutrition group had a significantly shorter duration of postoperative fever -lsb- ( @ ) h vs. ( @ ) h , p < @ -rsb- , a shorter interval to flatus -lsb- ( @ ) h vs. ( @ ) h , p < @ -rsb- , a shorter hospital stay -lsb- ( @ ) d vs. ( @ ) d , p < @ -rsb- and lower medical cost -lsb- ( @@ ) yuan vs. ( @@ ) yuan , p < @ -rsb- . there was no significant difference in complication morbidity between the two groups -lsb- @ % ( @/@ ) vs. @ % ( @/@ ) , p > @ -rsb- . the albumin , prealbumin , and retinol binding protein on the third and seventh postoperative days were significantly higher in early oral enteral nutrition group ( p < @ ) , while the rest energy expense ( ree ) and lnhoma-ir were significantly lower as compared to early fasting group ( all p < @ ) . early oral enteral nutrition after colorectal cancer operation is safe and effective , which is a natural route of nutrition and can reduce the stress response related to surgery , improve postoperative patients ' nutritional status and accelerate rehabilitation .
25,341,903
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "enhanced reduction of multinodular goiter ( mng ) can be achieved by stimulation with recombinant human thyrotropin ( rhtsh ) before radioiodine ( ( @ ) i ) therapy .", "the objective was to compare the long-term efficacy and safety of two low doses of modified release rhtsh ( mrrhtsh ) in combination with ( @ ) i therapy .", "in this phase ii , single-blinded , placebo-controlled study , @ patients ( @ @ years old , @ % women , @ % caucasians ) with mng ( median size @ ml ; range @-@ @ ml ) were randomized to receive placebo ( n = @ ) , @ mg mrrhtsh ( n = @ ) , or @ mg mrrhtsh ( n = @ ) @ hours before a calculated ( @ ) i activity .", "thyroid volume ( tv ) and smallest cross-sectional area of trachea ( scat ) were measured ( by computed tomography scan ) at baseline , six months , and @ months .", "thyroid function and quality of life ( qol ) was evaluated at three-month and yearly intervals respectively .", "at six months , tv reduction was enhanced in the @ mg mrrhtsh group ( @ % vs. @ % in the placebo group ; p = @ ) but not in the @ mg mrrhtsh group .", "at @ months , the mean percent tv reduction from baseline was @ @ % ( sd ) in the placebo group , @ @ % in the @ mg mrrhtsh group , and @ @ % in the @ mg mrrhtsh group , with no statistically significant differences among the groups , p = @ .", "in the @ mg mrrhtsh group , the subset of patients with basal ( @ ) i uptake < @ % had a @ % greater tv reduction at @ months than the corresponding subset of patients in the placebo group ( p = @ ) .", "at @ months , the largest relative increase in scat was observed in the @ mg mrrhtsh group ( @ @ % ) , but this was not statistically different from the increases observed in the placebo or the @ mg mrrhtsh group ( p = @ ) .", "goiter-related symptoms were reduced and qol improved , without any enhanced benefit from using mrrhtsh .", "at three years , the prevalence of permanent hypothyroidism was @ % , @ % , and @ % in the placebo , @ mg , and @ mg mrrhtsh groups respectively .", "the overall safety profile of the study was favorable .", "when used as adjuvant to ( @ ) i , enhanced mng reduction could not be demonstrated with mrrhtsh doses @ mg , indicating that the lower threshold for efficacy is around this level ." ]
enhanced reduction of multinodular goiter ( mng ) can be achieved by stimulation with recombinant human thyrotropin ( rhtsh ) before radioiodine ( ( @ ) i ) therapy . the objective was to compare the long-term efficacy and safety of two low doses of modified release rhtsh ( mrrhtsh ) in combination with ( @ ) i therapy . in this phase ii , single-blinded , placebo-controlled study , @ patients ( @ @ years old , @ % women , @ % caucasians ) with mng ( median size @ ml ; range @-@ @ ml ) were randomized to receive placebo ( n = @ ) , @ mg mrrhtsh ( n = @ ) , or @ mg mrrhtsh ( n = @ ) @ hours before a calculated ( @ ) i activity . thyroid volume ( tv ) and smallest cross-sectional area of trachea ( scat ) were measured ( by computed tomography scan ) at baseline , six months , and @ months . thyroid function and quality of life ( qol ) was evaluated at three-month and yearly intervals respectively . at six months , tv reduction was enhanced in the @ mg mrrhtsh group ( @ % vs. @ % in the placebo group ; p = @ ) but not in the @ mg mrrhtsh group . at @ months , the mean percent tv reduction from baseline was @ @ % ( sd ) in the placebo group , @ @ % in the @ mg mrrhtsh group , and @ @ % in the @ mg mrrhtsh group , with no statistically significant differences among the groups , p = @ . in the @ mg mrrhtsh group , the subset of patients with basal ( @ ) i uptake < @ % had a @ % greater tv reduction at @ months than the corresponding subset of patients in the placebo group ( p = @ ) . at @ months , the largest relative increase in scat was observed in the @ mg mrrhtsh group ( @ @ % ) , but this was not statistically different from the increases observed in the placebo or the @ mg mrrhtsh group ( p = @ ) . goiter-related symptoms were reduced and qol improved , without any enhanced benefit from using mrrhtsh . at three years , the prevalence of permanent hypothyroidism was @ % , @ % , and @ % in the placebo , @ mg , and @ mg mrrhtsh groups respectively . the overall safety profile of the study was favorable . when used as adjuvant to ( @ ) i , enhanced mng reduction could not be demonstrated with mrrhtsh doses @ mg , indicating that the lower threshold for efficacy is around this level .
24,341,527
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "intervention of medical clowns ( mc ) during various medical procedures performed in children has been used to relieve anxiety and pain .", "their role in allergy skin testing has never been evaluated .", "to evaluate whether mc can diminish pain and anxiety perceived by children undergoing allergy skin prick tests ( spt ) .", "in a prospective , randomized , controlled , and blinded study , children undergoing spt were or were not accompanied by mc .", "all parents and children @years completed the state-trait anxiety inventory ( stai ) before and after spt .", "videotapes recorded during the procedure were scored for anxiety ( m-ypas ) for all children and for pain ( flacc ) for children @-@years old by a psychologist who was unaware of the mc 's presence .", "after spt , children @years completed a visual analog score ( vas ) for pain .", "ninety-one children ( mean age @ years , m/f = @/@ ) were recruited of whom @ were accompanied by clowns .", "a significant reduction in state-stai was found in the clowns group , in both parents and children , when compared with the regular group ( @ and @ ; p = @ , and @ and @ ; p = @ , respectively ) .", "both m-ypas and flacc were reduced in the clowns group compared with the regular one .", "in the clowns group , m-ypas positively correlated with both vas and flacc ( p = @ and @ , respectively ) .", "m-ypas was positively correlated with flacc in the regular group ( p = @ ) .", "medical clowns significantly decrease the level of anxiety perceived by both children undergoing allergy spt and their parents , as well as the pain perceived by young children ." ]
intervention of medical clowns ( mc ) during various medical procedures performed in children has been used to relieve anxiety and pain . their role in allergy skin testing has never been evaluated . to evaluate whether mc can diminish pain and anxiety perceived by children undergoing allergy skin prick tests ( spt ) . in a prospective , randomized , controlled , and blinded study , children undergoing spt were or were not accompanied by mc . all parents and children @years completed the state-trait anxiety inventory ( stai ) before and after spt . videotapes recorded during the procedure were scored for anxiety ( m-ypas ) for all children and for pain ( flacc ) for children @-@years old by a psychologist who was unaware of the mc 's presence . after spt , children @years completed a visual analog score ( vas ) for pain . ninety-one children ( mean age @ years , m/f = @/@ ) were recruited of whom @ were accompanied by clowns . a significant reduction in state-stai was found in the clowns group , in both parents and children , when compared with the regular group ( @ and @ ; p = @ , and @ and @ ; p = @ , respectively ) . both m-ypas and flacc were reduced in the clowns group compared with the regular one . in the clowns group , m-ypas positively correlated with both vas and flacc ( p = @ and @ , respectively ) . m-ypas was positively correlated with flacc in the regular group ( p = @ ) . medical clowns significantly decrease the level of anxiety perceived by both children undergoing allergy spt and their parents , as well as the pain perceived by young children .
24,943,088
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "an immune-enhancing diet has been used to alter eicosanoid synthesis , cytokine production , and immune function in an attempt to limit the undesired immune reactions after injury from surgery .", "this prospective randomized study was designed to investigate the effect of preoperative immunonutrition on operative complications , and the participation of prostaglandin e@ ( pge@ ) on t-cell differentiation in patients undergoing a severely stressful surgery .", "the enrolled patients who were scheduled to undergo pancreatoduodenectomy were randomized into two groups .", "patients in the immunonutrition group ( n = @ ) received oral supplementation containing arginine , -@ fatty acids , and rna for @ days before the procedure in addition to a @ % reduction in the amount of regular food .", "patients in the control group ( n = @ ) received no artificial nutrition and were allowed to consume regular food before surgery .", "all patients received early postoperative enteral infusion of a standard formula intended to provide @ kcal/kg/day .", "the primary endpoint was the rate of infectious complications ; the secondary endpoint was immune responses .", "this study is registered with clinicaltrials.gov ( nct@ ) .", "infectious complication rate and severity of complications ( clavien-dindo classification ) were lesser in the immunonutrition group than in the control group .", "mrna expression levels of t-bet were greater in the immunonutrition group than in the control group ( p < @ ) .", "serum eicosapentaenoic acid and eicosapentaenoic acid/arachidonic acid ratios were greater in the immunonutrition group than in the control group ( p < @ ) .", "the levels of plasma pge@ were lesser in the immunonutrition group than in the control group ( p < @ ) .", "preoperative immunonutrition modulates pge@ production and t-cell differentiation and may protect against the aggravation of operative complications in patients undergoing pancreatoduodenectomy ." ]
an immune-enhancing diet has been used to alter eicosanoid synthesis , cytokine production , and immune function in an attempt to limit the undesired immune reactions after injury from surgery . this prospective randomized study was designed to investigate the effect of preoperative immunonutrition on operative complications , and the participation of prostaglandin e@ ( pge@ ) on t-cell differentiation in patients undergoing a severely stressful surgery . the enrolled patients who were scheduled to undergo pancreatoduodenectomy were randomized into two groups . patients in the immunonutrition group ( n = @ ) received oral supplementation containing arginine , -@ fatty acids , and rna for @ days before the procedure in addition to a @ % reduction in the amount of regular food . patients in the control group ( n = @ ) received no artificial nutrition and were allowed to consume regular food before surgery . all patients received early postoperative enteral infusion of a standard formula intended to provide @ kcal/kg/day . the primary endpoint was the rate of infectious complications ; the secondary endpoint was immune responses . this study is registered with clinicaltrials.gov ( nct@ ) . infectious complication rate and severity of complications ( clavien-dindo classification ) were lesser in the immunonutrition group than in the control group . mrna expression levels of t-bet were greater in the immunonutrition group than in the control group ( p < @ ) . serum eicosapentaenoic acid and eicosapentaenoic acid/arachidonic acid ratios were greater in the immunonutrition group than in the control group ( p < @ ) . the levels of plasma pge@ were lesser in the immunonutrition group than in the control group ( p < @ ) . preoperative immunonutrition modulates pge@ production and t-cell differentiation and may protect against the aggravation of operative complications in patients undergoing pancreatoduodenectomy .
24,589,090
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to determine if sleep talkers with rem sleep behavior disorder ( rbd ) would utter during rem sleep sentences learned before sleep , and to evaluate their verbal memory consolidation during sleep .", "eighteen patients with rbd and @ controls performed two verbal memory tasks ( @ words from the free and cued selective reminding test and a @-@ word long modified story recall test ) in the evening , followed by nocturnal video-polysomnography and morning recall ( night-time consolidation ) .", "in @ patients with rbd , daytime consolidation ( morning learning/recall , evening recall ) was also evaluated with the modified story recall test in a cross-over order .", "two rbd patients with dementia were studied separately .", "sleep talking was recorded using video-polysomnography , and the utterances were compared to the studied texts by two external judges .", "sleep-related verbal memory consolidation was maintained in patients with rbd ( +@ % words ) as in controls ( +@ % , p = @ ) .", "the two demented patients with rbd also exhibited excellent nighttime consolidation .", "the post-sleep performance was unrelated to the sleep measures ( including continuity , stages , fragmentation and apnea-hypopnea index ) .", "daytime consolidation ( -@ % ) was worse than night-time consolidation ( +@ % , p = @ ) in the subgroup of @ patients with rbd .", "eleven patients with rbd spoke during rem sleep and pronounced a median of @ words , which represented @ % of sleep with spoken language .", "a single patient uttered a sentence that was judged to be semantically ( but not literally ) related to the text learned before sleep .", "verbal declarative memory normally consolidates during sleep in patients with rbd .", "the incorporation of learned material within rem sleep-associated sleep talking in one patient ( unbeknownst to himself ) at the semantic level suggests a replay at a highly cognitive creative level ." ]
to determine if sleep talkers with rem sleep behavior disorder ( rbd ) would utter during rem sleep sentences learned before sleep , and to evaluate their verbal memory consolidation during sleep . eighteen patients with rbd and @ controls performed two verbal memory tasks ( @ words from the free and cued selective reminding test and a @-@ word long modified story recall test ) in the evening , followed by nocturnal video-polysomnography and morning recall ( night-time consolidation ) . in @ patients with rbd , daytime consolidation ( morning learning/recall , evening recall ) was also evaluated with the modified story recall test in a cross-over order . two rbd patients with dementia were studied separately . sleep talking was recorded using video-polysomnography , and the utterances were compared to the studied texts by two external judges . sleep-related verbal memory consolidation was maintained in patients with rbd ( +@ % words ) as in controls ( +@ % , p = @ ) . the two demented patients with rbd also exhibited excellent nighttime consolidation . the post-sleep performance was unrelated to the sleep measures ( including continuity , stages , fragmentation and apnea-hypopnea index ) . daytime consolidation ( -@ % ) was worse than night-time consolidation ( +@ % , p = @ ) in the subgroup of @ patients with rbd . eleven patients with rbd spoke during rem sleep and pronounced a median of @ words , which represented @ % of sleep with spoken language . a single patient uttered a sentence that was judged to be semantically ( but not literally ) related to the text learned before sleep . verbal declarative memory normally consolidates during sleep in patients with rbd . the incorporation of learned material within rem sleep-associated sleep talking in one patient ( unbeknownst to himself ) at the semantic level suggests a replay at a highly cognitive creative level .
24,349,492
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "this is a randomized comparative study of the efficacy of celecoxib and loxoprofen in patients with frozen shoulder ( scapulohumeral periarthritis ) .", "patients with frozen shoulder who presented with pain as the symptom were divided at random into a celecoxib treatment group ( @ mg/dose , twice daily ; n = @ ) and a loxoprofen treatment group ( @ mg/dose , @ times daily ; n = @ ) .", "medication was continued for @-@ weeks in each group .", "each patient was asked to rate the pain on a visual analog scale ( score @-@ ) .", "this score significantly improved ( indicating marked alleviation of pain ) in both the celecoxib group ( from @ @ before treatment to @ @ after treatment ) and the loxoprofen group ( from @ @ before treatment to @ @ after treatment ) .", "in the analysis of disappearance of pain , the percentage of patients showing disappearance of nocturnal pain was significantly higher in the celecoxib group ( @ % ) than in the loxoprofen group ( @ % ) .", "the results confirm that celecoxib is comparable to loxoprofen in terms of analgesic efficacy in patients with frozen shoulder .", "among other findings , we report that celecoxib was more effective for nocturnal pain than loxoprofen ." ]
this is a randomized comparative study of the efficacy of celecoxib and loxoprofen in patients with frozen shoulder ( scapulohumeral periarthritis ) . patients with frozen shoulder who presented with pain as the symptom were divided at random into a celecoxib treatment group ( @ mg/dose , twice daily ; n = @ ) and a loxoprofen treatment group ( @ mg/dose , @ times daily ; n = @ ) . medication was continued for @-@ weeks in each group . each patient was asked to rate the pain on a visual analog scale ( score @-@ ) . this score significantly improved ( indicating marked alleviation of pain ) in both the celecoxib group ( from @ @ before treatment to @ @ after treatment ) and the loxoprofen group ( from @ @ before treatment to @ @ after treatment ) . in the analysis of disappearance of pain , the percentage of patients showing disappearance of nocturnal pain was significantly higher in the celecoxib group ( @ % ) than in the loxoprofen group ( @ % ) . the results confirm that celecoxib is comparable to loxoprofen in terms of analgesic efficacy in patients with frozen shoulder . among other findings , we report that celecoxib was more effective for nocturnal pain than loxoprofen .
24,261,771
[ "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "prescription opioid dependence is increasing and creates a significant public health burden , but primary care physicians lack evidence-based guidelines to decide between tapering doses followed by discontinuation of buprenorphine hydrochloride and naloxone hydrochloride therapy ( hereinafter referred to as buprenorphine therapy ) or ongoing maintenance therapy .", "to determine the efficacy of buprenorphine taper vs ongoing maintenance therapy in primary care-based treatment for prescription opioid dependence .", "we conducted a @-week randomized clinical trial that enrolled @ patients with prescription opioid dependence from february @ , @ , through february @ , @ , in a single primary care site .", "patients were randomized to buprenorphine taper ( taper condition ) or ongoing buprenorphine maintenance therapy ( maintenance condition ) .", "the buprenorphine taper was initiated after @ weeks of stabilization , lasted for @ weeks , and included medications for opioid withdrawal , after which patients were offered naltrexone treatment .", "the maintenance group received ongoing buprenorphine therapy .", "all patients received physician and nurse support and drug counseling .", "illicit opioid use via results of urinanalysis and patient report , treatment retention , and reinitiation of buprenorphine therapy ( taper group only ) .", "during the trial , the mean percentage of urine samples negative for opioids was lower for patients in the taper group ( @ % -lsb- @ % ci , @ % -@ % -rsb- ) compared with those in the maintenance group ( @ % -lsb- @ % ci , @ % -@ % -rsb- ) .", "patients in the taper group reported more days per week of illicit opioid use than those in the maintenance group once they were no longer receiving buprenorphine ( mean use , @ -lsb- @ % ci , @-@ @ -rsb- vs @ -lsb- @ % ci , @-@ @ -rsb- days ) .", "patients in the taper group had fewer maximum consecutive weeks of opioid abstinence compared with those in the maintenance group ( mean abstinence , @ -lsb- @ % ci , @-@ @ -rsb- vs @ -lsb- @ % ci , @-@ @ -rsb- weeks ) .", "patients in the taper group were less likely to complete the trial ( @ of @ -lsb- @ % -rsb- vs @ of @ -lsb- @ % -rsb- ; p < @ ) .", "sixteen patients in the taper group reinitiated buprenorphine treatment after the taper owing to relapse .", "tapering is less efficacious than ongoing maintenance treatment in patients with prescription opioid dependence who receive buprenorphine therapy in primary care .", "clinicaltrials.gov identifier : nct@ ." ]
prescription opioid dependence is increasing and creates a significant public health burden , but primary care physicians lack evidence-based guidelines to decide between tapering doses followed by discontinuation of buprenorphine hydrochloride and naloxone hydrochloride therapy ( hereinafter referred to as buprenorphine therapy ) or ongoing maintenance therapy . to determine the efficacy of buprenorphine taper vs ongoing maintenance therapy in primary care-based treatment for prescription opioid dependence . we conducted a @-week randomized clinical trial that enrolled @ patients with prescription opioid dependence from february @ , @ , through february @ , @ , in a single primary care site . patients were randomized to buprenorphine taper ( taper condition ) or ongoing buprenorphine maintenance therapy ( maintenance condition ) . the buprenorphine taper was initiated after @ weeks of stabilization , lasted for @ weeks , and included medications for opioid withdrawal , after which patients were offered naltrexone treatment . the maintenance group received ongoing buprenorphine therapy . all patients received physician and nurse support and drug counseling . illicit opioid use via results of urinanalysis and patient report , treatment retention , and reinitiation of buprenorphine therapy ( taper group only ) . during the trial , the mean percentage of urine samples negative for opioids was lower for patients in the taper group ( @ % -lsb- @ % ci , @ % -@ % -rsb- ) compared with those in the maintenance group ( @ % -lsb- @ % ci , @ % -@ % -rsb- ) . patients in the taper group reported more days per week of illicit opioid use than those in the maintenance group once they were no longer receiving buprenorphine ( mean use , @ -lsb- @ % ci , @-@ @ -rsb- vs @ -lsb- @ % ci , @-@ @ -rsb- days ) . patients in the taper group had fewer maximum consecutive weeks of opioid abstinence compared with those in the maintenance group ( mean abstinence , @ -lsb- @ % ci , @-@ @ -rsb- vs @ -lsb- @ % ci , @-@ @ -rsb- weeks ) . patients in the taper group were less likely to complete the trial ( @ of @ -lsb- @ % -rsb- vs @ of @ -lsb- @ % -rsb- ; p < @ ) . sixteen patients in the taper group reinitiated buprenorphine treatment after the taper owing to relapse . tapering is less efficacious than ongoing maintenance treatment in patients with prescription opioid dependence who receive buprenorphine therapy in primary care . clinicaltrials.gov identifier : nct@ .
25,330,017
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]
[ "the ox@/ox@l interaction contributes to an optimal t cell response following allergic stimuli and plays an important role in the maintenance and reactivation of memory t effector cells .", "we tested whether treatment with an anti-ox@l monoclonal antibody ( mab ) would inhibit allergen-induced responses in subjects with asthma .", "twenty-eight mild , atopic asthmatic subjects were recruited for a double-blind , randomized , placebo-controlled , parallel-group trial ( clinicaltrials.gov identifier nct@ ) to compare blockade of ox@l using a humanized anti-ox@l mab to placebo-administered intravenously in @ doses over @ months .", "allergen inhalation challenges were carried out @ and @ days after the first dose of study drug .", "the primary outcome variable was the late-phase asthmatic response .", "other outcomes included the early-phase asthmatic response , airway hyperresponsiveness , serum ige levels , blood and sputum eosinophils , safety and tolerability .", "treatment with anti-ox@l mab did not attenuate the early - or late-phase asthmatic responses at days @ or @ compared with placebo .", "in the anti-ox@l mab treatment group , total ige was reduced @ % from pre-dosing levels , and sputum eosinophils decreased @ % by day @ ( both p = @ ) .", "there was no effect of anti-ox@l mab on airway hyperresponsiveness or blood eosinophils .", "the frequency of aes was similar in both groups .", "pharmacological activity of anti-ox@l mab was observed by decreases in serum total ige and airway eosinophils at @ weeks post-dosing , but there was no effect on allergen-induced airway responses .", "it is possible that the treatment duration or dose of antibody was insufficient to impact the airway responses ." ]
the ox@/ox@l interaction contributes to an optimal t cell response following allergic stimuli and plays an important role in the maintenance and reactivation of memory t effector cells . we tested whether treatment with an anti-ox@l monoclonal antibody ( mab ) would inhibit allergen-induced responses in subjects with asthma . twenty-eight mild , atopic asthmatic subjects were recruited for a double-blind , randomized , placebo-controlled , parallel-group trial ( clinicaltrials.gov identifier nct@ ) to compare blockade of ox@l using a humanized anti-ox@l mab to placebo-administered intravenously in @ doses over @ months . allergen inhalation challenges were carried out @ and @ days after the first dose of study drug . the primary outcome variable was the late-phase asthmatic response . other outcomes included the early-phase asthmatic response , airway hyperresponsiveness , serum ige levels , blood and sputum eosinophils , safety and tolerability . treatment with anti-ox@l mab did not attenuate the early - or late-phase asthmatic responses at days @ or @ compared with placebo . in the anti-ox@l mab treatment group , total ige was reduced @ % from pre-dosing levels , and sputum eosinophils decreased @ % by day @ ( both p = @ ) . there was no effect of anti-ox@l mab on airway hyperresponsiveness or blood eosinophils . the frequency of aes was similar in both groups . pharmacological activity of anti-ox@l mab was observed by decreases in serum total ige and airway eosinophils at @ weeks post-dosing , but there was no effect on allergen-induced airway responses . it is possible that the treatment duration or dose of antibody was insufficient to impact the airway responses .
24,224,471
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the aim of this study was to determine the efficacy and tolerability of hydromorphone extended release ( er ) in patients with chronic low back pain ( lbp ) with or without a neuropathic component .", "this was a post hoc analysis of data from a multicenter , double-blind , placebo-controlled clinical trial using a randomized withdrawal design , performed in patients with moderate to severe chronic lbp .", "patients achieving stable doses of hydromorphone er during a @ - to @-week conversion and titration phase were randomized to continue treatment with hydromorphone er or taper-down to placebo during a @-week double-blind phase .", "the primary efficacy outcome was the mean change in @-point numeric rating scale ( nrs ) pain intensity score from randomization to the final visit of the double-blind phase .", "tolerability was assessed by recording adverse events ( aes ) .", "data were analyzed separately for patients with non-neuropathic and neuropathic lbp .", "a total of @ patients with non-neuropathic/nociceptive lbp and @ with neuropathic lbp were randomized into the double-blind phase .", "during the conversion and titration phase , mean ( sd ) nrs scores decreased significantly from @ ( @ ) and @ ( @ ) at screening to @ ( @ ) and @ ( @ ) , respectively .", "for both lbp subgroups , patients randomized to hydromorphone er maintained this improvement over the double-blind treatment period , whereas those randomized to placebo reported significant increase in nrs scores .", "across subgroups , the incidence of @ or more ae was @ percent to @ percent in the conversion and titration phase and @ percent to @ percent in the double-blind phase .", "the results of this study indicate that hydromorphone er is efficacious and generally well tolerated in the management of patients with non-neuropathic and neuropathic chronic lbp ." ]
the aim of this study was to determine the efficacy and tolerability of hydromorphone extended release ( er ) in patients with chronic low back pain ( lbp ) with or without a neuropathic component . this was a post hoc analysis of data from a multicenter , double-blind , placebo-controlled clinical trial using a randomized withdrawal design , performed in patients with moderate to severe chronic lbp . patients achieving stable doses of hydromorphone er during a @ - to @-week conversion and titration phase were randomized to continue treatment with hydromorphone er or taper-down to placebo during a @-week double-blind phase . the primary efficacy outcome was the mean change in @-point numeric rating scale ( nrs ) pain intensity score from randomization to the final visit of the double-blind phase . tolerability was assessed by recording adverse events ( aes ) . data were analyzed separately for patients with non-neuropathic and neuropathic lbp . a total of @ patients with non-neuropathic/nociceptive lbp and @ with neuropathic lbp were randomized into the double-blind phase . during the conversion and titration phase , mean ( sd ) nrs scores decreased significantly from @ ( @ ) and @ ( @ ) at screening to @ ( @ ) and @ ( @ ) , respectively . for both lbp subgroups , patients randomized to hydromorphone er maintained this improvement over the double-blind treatment period , whereas those randomized to placebo reported significant increase in nrs scores . across subgroups , the incidence of @ or more ae was @ percent to @ percent in the conversion and titration phase and @ percent to @ percent in the double-blind phase . the results of this study indicate that hydromorphone er is efficacious and generally well tolerated in the management of patients with non-neuropathic and neuropathic chronic lbp .
25,350,473
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "low-dose ct screening is recommended for individuals at high risk of developing lung cancer .", "however , ct screening does not detect all lung cancers : some might be missed at screening , and others can develop in the interval between screens .", "the nelson trial is a randomised trial to assess the effect of screening with increasing screening intervals on lung cancer mortality .", "in this prespecified analysis , we aimed to assess screening test performance , and the epidemiological , radiological , and clinical characteristics of interval cancers in nelson trial participants assigned to the screening group .", "eligible participants in the nelson trial were those aged @-@ years , who had smoked @ or more cigarettes per day for more than @ years or ten or more cigarettes for more than @ years , and were still smoking or had quit less than @ years ago .", "we included all participants assigned to the screening group who had attended at least one round of screening .", "screening test results were based on volumetry using a two-step approach .", "initially , screening test results were classified as negative , indeterminate , or positive based on nodule presence and volume .", "subsequently , participants with an initial indeterminate result underwent follow-up screening to classify their final screening test result as negative or positive , based on nodule volume doubling time .", "we obtained information about all lung cancer diagnoses made during the first three rounds of screening , plus an additional @ years of follow-up from the national cancer registry .", "we determined epidemiological , radiological , participant , and tumour characteristics by reassessing medical files , screening cts , and clinical cts .", "the nelson trial is registered at www.trialregister.nl , number isrctn@ .", "@,@ participants were enrolled in the nelson trial , of whom @ were assigned to low-dose ct screening with increasing interval between screens , and @ to no screening .", "we included @ participants in our study , with median follow-up of @ years ( iqr @-@ ) .", "@ ( @ % ) of @ screened participants were diagnosed with @ screen-detected lung cancers , and another @ ( < @ % ; @ -lsb- @ % -rsb- in the first year after screening , and @ -lsb- @ % -rsb- in the second year after screening ) were diagnosed with @ interval cancers .", "for the three screening rounds combined , with a @-year follow-up , sensitivity was @ % ( @ % ci @-@ ) , specificity was @ % ( @ % ci @-@ ) , positive predictive value was @ % ( @ % ci @-@ ) , and negative predictive value was @ % ( @ % ci @-@ ) .", "retrospective assessment of the last screening ct and clinical ct in @ patients with interval cancer showed that interval cancers were not visible in @ ( @ % ) cases .", "in the remaining cases , cancers were visible when retrospectively assessed , but were not diagnosed because of radiological detection and interpretation errors ( @ -lsb- @ % -rsb- ) , misclassification by the protocol ( two -lsb- @ % -rsb- ) , participant non-compliance ( two -lsb- @ % -rsb- ) , and non-adherence to protocol ( one -lsb- @ % -rsb- ) .", "compared with screen-detected cancers , interval cancers were diagnosed at more advanced stages ( @ -lsb- @ % -rsb- of @ interval cancers vs @ -lsb- @ % -rsb- of @ screen-detected cancers diagnosed in stage iii or iv ; p < @ ) , were more often small-cell carcinomas ( seven -lsb- @ % -rsb- vs eight -lsb- @ % -rsb- ; p = @ ) and less often adenocarcinomas ( nine -lsb- @ % -rsb- vs @ -lsb- @ % -rsb- ; p = @ ) .", "lung cancer screening in the nelson trial yielded high specificity and sensitivity , with only a small number of interval cancers .", "the results of this study could be used to improve screening algorithms , and reduce the number of missed cancers .", "zorgonderzoek nederland medische wetenschappen and koningin wilhelmina fonds ." ]
low-dose ct screening is recommended for individuals at high risk of developing lung cancer . however , ct screening does not detect all lung cancers : some might be missed at screening , and others can develop in the interval between screens . the nelson trial is a randomised trial to assess the effect of screening with increasing screening intervals on lung cancer mortality . in this prespecified analysis , we aimed to assess screening test performance , and the epidemiological , radiological , and clinical characteristics of interval cancers in nelson trial participants assigned to the screening group . eligible participants in the nelson trial were those aged @-@ years , who had smoked @ or more cigarettes per day for more than @ years or ten or more cigarettes for more than @ years , and were still smoking or had quit less than @ years ago . we included all participants assigned to the screening group who had attended at least one round of screening . screening test results were based on volumetry using a two-step approach . initially , screening test results were classified as negative , indeterminate , or positive based on nodule presence and volume . subsequently , participants with an initial indeterminate result underwent follow-up screening to classify their final screening test result as negative or positive , based on nodule volume doubling time . we obtained information about all lung cancer diagnoses made during the first three rounds of screening , plus an additional @ years of follow-up from the national cancer registry . we determined epidemiological , radiological , participant , and tumour characteristics by reassessing medical files , screening cts , and clinical cts . the nelson trial is registered at www.trialregister.nl , number isrctn@ . @,@ participants were enrolled in the nelson trial , of whom @ were assigned to low-dose ct screening with increasing interval between screens , and @ to no screening . we included @ participants in our study , with median follow-up of @ years ( iqr @-@ ) . @ ( @ % ) of @ screened participants were diagnosed with @ screen-detected lung cancers , and another @ ( < @ % ; @ -lsb- @ % -rsb- in the first year after screening , and @ -lsb- @ % -rsb- in the second year after screening ) were diagnosed with @ interval cancers . for the three screening rounds combined , with a @-year follow-up , sensitivity was @ % ( @ % ci @-@ ) , specificity was @ % ( @ % ci @-@ ) , positive predictive value was @ % ( @ % ci @-@ ) , and negative predictive value was @ % ( @ % ci @-@ ) . retrospective assessment of the last screening ct and clinical ct in @ patients with interval cancer showed that interval cancers were not visible in @ ( @ % ) cases . in the remaining cases , cancers were visible when retrospectively assessed , but were not diagnosed because of radiological detection and interpretation errors ( @ -lsb- @ % -rsb- ) , misclassification by the protocol ( two -lsb- @ % -rsb- ) , participant non-compliance ( two -lsb- @ % -rsb- ) , and non-adherence to protocol ( one -lsb- @ % -rsb- ) . compared with screen-detected cancers , interval cancers were diagnosed at more advanced stages ( @ -lsb- @ % -rsb- of @ interval cancers vs @ -lsb- @ % -rsb- of @ screen-detected cancers diagnosed in stage iii or iv ; p < @ ) , were more often small-cell carcinomas ( seven -lsb- @ % -rsb- vs eight -lsb- @ % -rsb- ; p = @ ) and less often adenocarcinomas ( nine -lsb- @ % -rsb- vs @ -lsb- @ % -rsb- ; p = @ ) . lung cancer screening in the nelson trial yielded high specificity and sensitivity , with only a small number of interval cancers . the results of this study could be used to improve screening algorithms , and reduce the number of missed cancers . zorgonderzoek nederland medische wetenschappen and koningin wilhelmina fonds .
25,282,284
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "despite the beneficial effect of cardiac rehabilitation after myocardial infarction , a rehabilitation program to improve cardiorespiratory fitness and influence secondary prevention has not been implemented for ischemic stroke and transient ischemic attack ( tia ) .", "to investigate the safety and feasibility of a post-stroke care including an exercise program after minor ischemic stroke or tia .", "in a randomised controlled trial , @ patients with a recent minor stroke or tia without cardiac contraindications were randomly assigned to one of the two interventions ; post-stroke care without exercise or post-stroke care with exercise .", "patients were evaluated at baseline , @ and @ months .", "eighteen patients completed the intervention .", "in none of the patients cardiopulmonary contraindications for the maximal exercise test and exercise program were found .", "no cardiovascular events occurred during the maximal exercise tests and exercise program .", "after one year , significantly more patients in the post-stroke care with exercise group achieved the composite endpoint of optimal medical therapy .", "post-stroke care including an exercise program is safe and feasible in the acute phase after minor stroke or tia and might be a way to increase effectiveness of secondary stroke prevention .", "we are currently conducting a larger trial to validate these results ." ]
despite the beneficial effect of cardiac rehabilitation after myocardial infarction , a rehabilitation program to improve cardiorespiratory fitness and influence secondary prevention has not been implemented for ischemic stroke and transient ischemic attack ( tia ) . to investigate the safety and feasibility of a post-stroke care including an exercise program after minor ischemic stroke or tia . in a randomised controlled trial , @ patients with a recent minor stroke or tia without cardiac contraindications were randomly assigned to one of the two interventions ; post-stroke care without exercise or post-stroke care with exercise . patients were evaluated at baseline , @ and @ months . eighteen patients completed the intervention . in none of the patients cardiopulmonary contraindications for the maximal exercise test and exercise program were found . no cardiovascular events occurred during the maximal exercise tests and exercise program . after one year , significantly more patients in the post-stroke care with exercise group achieved the composite endpoint of optimal medical therapy . post-stroke care including an exercise program is safe and feasible in the acute phase after minor stroke or tia and might be a way to increase effectiveness of secondary stroke prevention . we are currently conducting a larger trial to validate these results .
24,473,242
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "@ subjects with type @ diabetes and moderate to severe cp were randomly distributed to groups receiving either nspt or ohi .", "periodontal parameters , glycosylated haemoglobin ( hba@c ) and high-sensitivity c-reactive protein ( hs-crp ) were evaluated at baseline , @ - and @-months intervals .", "@ subjects with type @ diabetes and moderate to severe cp were randomly distributed to groups receiving either nspt or ohi .", "periodontal parameters , glycosylated haemoglobin ( hba@c ) and high-sensitivity c-reactive protein ( hs-crp ) were evaluated at baseline , @ - and @-months intervals .", "@ subjects from nspt group and @ from ohi group completed the study .", "the difference in plaque index ( pi ) between nspt and ohi groups were significant at @ months recall ( p = @ ) .", "there was no significant difference between nspt and ohi group for all other clinical periodontal parameters , hba@c and crp levels .", "at @ months post-therapy , periodontal parameters improved significantly in both groups with sites with probing pocket depth ( ppd ) < @ mm reported as @ @ % in nspt group and @ @ % in ohi group .", "mean ppd and mean probing attachment loss ( pal ) within the nspt group reduced significantly from baseline ( @ @ mm , @ @ mm ) to final visit ( @ @ mm , @ @ mm ) ( p = @ , p < @ ) .", "for ohi group , improvements in mean ppd and mean pal were also seen from baseline ( @ @ mm , @ @ mm ) to final visit ( @ @ mm , @ @ mm ) ( p < @ for both ) .", "similarly , hba@c levels decreased in both groups with nspt group recording statistically significant reduction ( p = @ ) .", "participants who demonstrated @ % reduction in ppd showed significant reductions of hba@c and hs-crp levels ( p = @ and p = @ ) .", "nspt significantly reduced pi at @ months post-therapy as compared to ohi .", "both nspt and ohi demonstrated improvements in other clinical parameters as well as hba@c and crp levels .", "clinicaltrials.gov : nct@ ." ]
@ subjects with type @ diabetes and moderate to severe cp were randomly distributed to groups receiving either nspt or ohi . periodontal parameters , glycosylated haemoglobin ( hba@c ) and high-sensitivity c-reactive protein ( hs-crp ) were evaluated at baseline , @ - and @-months intervals . @ subjects with type @ diabetes and moderate to severe cp were randomly distributed to groups receiving either nspt or ohi . periodontal parameters , glycosylated haemoglobin ( hba@c ) and high-sensitivity c-reactive protein ( hs-crp ) were evaluated at baseline , @ - and @-months intervals . @ subjects from nspt group and @ from ohi group completed the study . the difference in plaque index ( pi ) between nspt and ohi groups were significant at @ months recall ( p = @ ) . there was no significant difference between nspt and ohi group for all other clinical periodontal parameters , hba@c and crp levels . at @ months post-therapy , periodontal parameters improved significantly in both groups with sites with probing pocket depth ( ppd ) < @ mm reported as @ @ % in nspt group and @ @ % in ohi group . mean ppd and mean probing attachment loss ( pal ) within the nspt group reduced significantly from baseline ( @ @ mm , @ @ mm ) to final visit ( @ @ mm , @ @ mm ) ( p = @ , p < @ ) . for ohi group , improvements in mean ppd and mean pal were also seen from baseline ( @ @ mm , @ @ mm ) to final visit ( @ @ mm , @ @ mm ) ( p < @ for both ) . similarly , hba@c levels decreased in both groups with nspt group recording statistically significant reduction ( p = @ ) . participants who demonstrated @ % reduction in ppd showed significant reductions of hba@c and hs-crp levels ( p = @ and p = @ ) . nspt significantly reduced pi at @ months post-therapy as compared to ohi . both nspt and ohi demonstrated improvements in other clinical parameters as well as hba@c and crp levels . clinicaltrials.gov : nct@ .
24,965,218
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "the early management of orthopaedic outpatients by physiotherapists may be useful in reducing public hospital waiting lists .", "physiotherapists in australia are prevented by legislation and funding models from investigating , prescribing , injecting and referring autonomously .", "this gap in service is particularly noticeable in the management of shoulder pain in early-access physiotherapy services , as patients needing corticosteroid injection face delays or transfer to other services for this procedure .", "this trial will investigate the clinical ( decision making and outcomes ) and economic feasibility of a physiotherapist prescribing and delivering corticosteroid and local anaesthetic injections for shoulder pain in an australian public hospital setting .", "a double-blinded ( patient and assessor ) non-inferiority randomised controlled trial will compare an orthopaedic surgeon and a physiotherapist prescribing and delivering corticosteroid injections to the shoulder .", "agreement in decision making between the two clinicians will be investigated , and economic information will be obtained for estimating disease burden and an economic evaluation .", "the surgeon and the physiotherapist will independently assess patients , and @ eligible participants will be randomised to receive subacromial injection of corticosteroid and local anaesthetic from either the surgeon or the physiotherapist .", "post-injection , all participants will receive physiotherapy .", "the primary outcome measure will be the shoulder pain and disability index measured at baseline , and at @ and @weeks post-injection .", "analysis will be conducted on an intention-to-treat basis and compared to a per-protocol analysis .", "a cost-utility analysis will be undertaken from the perspective of the health funder .", "findings will assist policy makers and services in improving access for orthopaedic patients .", "australia and new zealand clinical trials registry : @ first registered : @ may @ .", "first participant randomized : @ january @ ." ]
the early management of orthopaedic outpatients by physiotherapists may be useful in reducing public hospital waiting lists . physiotherapists in australia are prevented by legislation and funding models from investigating , prescribing , injecting and referring autonomously . this gap in service is particularly noticeable in the management of shoulder pain in early-access physiotherapy services , as patients needing corticosteroid injection face delays or transfer to other services for this procedure . this trial will investigate the clinical ( decision making and outcomes ) and economic feasibility of a physiotherapist prescribing and delivering corticosteroid and local anaesthetic injections for shoulder pain in an australian public hospital setting . a double-blinded ( patient and assessor ) non-inferiority randomised controlled trial will compare an orthopaedic surgeon and a physiotherapist prescribing and delivering corticosteroid injections to the shoulder . agreement in decision making between the two clinicians will be investigated , and economic information will be obtained for estimating disease burden and an economic evaluation . the surgeon and the physiotherapist will independently assess patients , and @ eligible participants will be randomised to receive subacromial injection of corticosteroid and local anaesthetic from either the surgeon or the physiotherapist . post-injection , all participants will receive physiotherapy . the primary outcome measure will be the shoulder pain and disability index measured at baseline , and at @ and @weeks post-injection . analysis will be conducted on an intention-to-treat basis and compared to a per-protocol analysis . a cost-utility analysis will be undertaken from the perspective of the health funder . findings will assist policy makers and services in improving access for orthopaedic patients . australia and new zealand clinical trials registry : @ first registered : @ may @ . first participant randomized : @ january @ .
25,527,842
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND" ]
[ "intestinal inflammation is a hallmark of cystic fibrosis ( cf ) .", "administration of probiotics can reduce intestinal inflammation and the incidence of pulmonary exacerbations .", "we investigated the composition of intestinal microbiota in children with cf and analyzed its relationship with intestinal inflammation .", "we also investigated the microflora structure before and after lactobacillus gg ( lgg ) administration in children with cf with and without antibiotic treatment .", "the intestinal microbiota were analyzed by denaturing gradient gel electrophoresis ( dgge ) , real-time polymerase chain reaction ( rt-pcr ) , and fluorescence in situ hybridization ( fish ) .", "intestinal inflammation was assessed by measuring fecal calprotectin ( clp ) and rectal nitric oxide ( rno ) production in children with cf as compared with healthy controls .", "we then carried out a small double-blind randomized clinical trial with lgg .", "twenty-two children with cf children were enrolled in the study ( median age , @ years ; range , @-@ years ) .", "fecal clp and rno levels were higher in children with cf than in healthy controls ( @ g/g vs. @ g/g ; @ vs. @ mol/l no@ ( - ) , respectively ; p < @ ) .", "compared with healthy controls , children with cf had significantly different intestinal microbial core structures .", "the levels of eubacterium rectale , bacteroides uniformis , bacteroides vulgatus , bifidobacterium adolescentis , bifidobacterium catenulatum , and faecalibacterium prausnitzii were reduced in children with cf. a similar but more extreme pattern was observed in children with cf who were taking antibiotics .", "lgg administration reduced fecal clp and partially restored intestinal microbiota .", "there was a significant correlation between reduced microbial richness and intestinal inflammation .", "cf causes qualitative and quantitative changes in intestinal microbiota , which may represent a novel therapeutic target in the treatment of cf. administration of probiotics restored gut microbiota , supporting the efficacy of probiotics in reducing intestinal inflammation and pulmonary exacerbations .", "clinicaltrials.gov nct @ ." ]
intestinal inflammation is a hallmark of cystic fibrosis ( cf ) . administration of probiotics can reduce intestinal inflammation and the incidence of pulmonary exacerbations . we investigated the composition of intestinal microbiota in children with cf and analyzed its relationship with intestinal inflammation . we also investigated the microflora structure before and after lactobacillus gg ( lgg ) administration in children with cf with and without antibiotic treatment . the intestinal microbiota were analyzed by denaturing gradient gel electrophoresis ( dgge ) , real-time polymerase chain reaction ( rt-pcr ) , and fluorescence in situ hybridization ( fish ) . intestinal inflammation was assessed by measuring fecal calprotectin ( clp ) and rectal nitric oxide ( rno ) production in children with cf as compared with healthy controls . we then carried out a small double-blind randomized clinical trial with lgg . twenty-two children with cf children were enrolled in the study ( median age , @ years ; range , @-@ years ) . fecal clp and rno levels were higher in children with cf than in healthy controls ( @ g/g vs. @ g/g ; @ vs. @ mol/l no@ ( - ) , respectively ; p < @ ) . compared with healthy controls , children with cf had significantly different intestinal microbial core structures . the levels of eubacterium rectale , bacteroides uniformis , bacteroides vulgatus , bifidobacterium adolescentis , bifidobacterium catenulatum , and faecalibacterium prausnitzii were reduced in children with cf. a similar but more extreme pattern was observed in children with cf who were taking antibiotics . lgg administration reduced fecal clp and partially restored intestinal microbiota . there was a significant correlation between reduced microbial richness and intestinal inflammation . cf causes qualitative and quantitative changes in intestinal microbiota , which may represent a novel therapeutic target in the treatment of cf. administration of probiotics restored gut microbiota , supporting the efficacy of probiotics in reducing intestinal inflammation and pulmonary exacerbations . clinicaltrials.gov nct @ .
24,586,292
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]
[ "to investigate the therapeutic effects of a manual therapy protocol for improving pain , function , pressure pain thresholds ( ppt ) , quality of sleep , and depressive symptoms in women and men with fibromyalgia syndrome ( fms ) .", "eighty-nine patients were randomly assigned to experimental or control group .", "the experimental group ( @ female , @ male ) received @ sessions of manual therapy and the control group ( @ female , @ male ) did not receive any intervention .", "ppt , pain , impact of fms symptoms , quality of sleep , and depressive symptoms were assessed in both groups at baseline and after @ hours of the last intervention in the experimental group .", "the analysis of covariance found significant grouptimesex interactions for mcgill ppi and center for epidemiologic studies depressive symptoms scale ( p < @ ) was also found : men exhibited a larger effect size for depressive symptoms than women , whereas women exhibited a greater effect size than men in the mcgill ppi .", "a significant grouptimesex interaction for ppt over suboccipital , upper trapezius , supraspinatus , second rib , gluteal region , and tibialis anterior muscle was also found : men included in the experimental group experienced significant greater improvements in ppt as compared with women with fms in the experimental group .", "manual therapy protocol was effective for improving pain intensity , widespread pressure pain sensitivity , impact of fms symptoms , sleep quality , and depressive symptoms .", "in addition , sex differences were observed in response to treatment : women and men get similar improvements in quality of sleep and tender point count , whereas women showed a greater reduction in pain and impact of fms symptoms than men , but men reported higher decreases in depressive symptoms and pressure hypersensitivity than women ." ]
to investigate the therapeutic effects of a manual therapy protocol for improving pain , function , pressure pain thresholds ( ppt ) , quality of sleep , and depressive symptoms in women and men with fibromyalgia syndrome ( fms ) . eighty-nine patients were randomly assigned to experimental or control group . the experimental group ( @ female , @ male ) received @ sessions of manual therapy and the control group ( @ female , @ male ) did not receive any intervention . ppt , pain , impact of fms symptoms , quality of sleep , and depressive symptoms were assessed in both groups at baseline and after @ hours of the last intervention in the experimental group . the analysis of covariance found significant grouptimesex interactions for mcgill ppi and center for epidemiologic studies depressive symptoms scale ( p < @ ) was also found : men exhibited a larger effect size for depressive symptoms than women , whereas women exhibited a greater effect size than men in the mcgill ppi . a significant grouptimesex interaction for ppt over suboccipital , upper trapezius , supraspinatus , second rib , gluteal region , and tibialis anterior muscle was also found : men included in the experimental group experienced significant greater improvements in ppt as compared with women with fms in the experimental group . manual therapy protocol was effective for improving pain intensity , widespread pressure pain sensitivity , impact of fms symptoms , sleep quality , and depressive symptoms . in addition , sex differences were observed in response to treatment : women and men get similar improvements in quality of sleep and tender point count , whereas women showed a greater reduction in pain and impact of fms symptoms than men , but men reported higher decreases in depressive symptoms and pressure hypersensitivity than women .
24,281,285
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "this study tested the effects of two fundamental forms of distraction , including visual-manual and cognitive-audio distraction , with comparison under both operational and tactical driving .", "strategic control remains for future study .", "driving is a complex control task involving operational , tactical , and strategic control .", "although operational control , such as lead-car following , has been studied , the influence of in-vehicle distractions on higher levels of control , including tactical and strategic , remains unclear .", "two secondary tasks were designed to independently represent visual-manual and cognitive-audio distractions , based on multiple resource theory .", "drivers performed operational vehicle control maneuvers ( lead-car following ) or tactical control maneuvers ( passing ) along with the distraction tasks in a driving simulator .", "response measures included driving performance and visual behavior .", "results revealed drivers ' ability to accommodate either visual or cognitive distractions in following tasks but not in passing .", "the simultaneous distraction condition led to the greatest decrement in performance .", "findings support the need to assess the impacts of in-vehicle distraction on different levels of driving control .", "future study should investigate driver distraction under strategic control ." ]
this study tested the effects of two fundamental forms of distraction , including visual-manual and cognitive-audio distraction , with comparison under both operational and tactical driving . strategic control remains for future study . driving is a complex control task involving operational , tactical , and strategic control . although operational control , such as lead-car following , has been studied , the influence of in-vehicle distractions on higher levels of control , including tactical and strategic , remains unclear . two secondary tasks were designed to independently represent visual-manual and cognitive-audio distractions , based on multiple resource theory . drivers performed operational vehicle control maneuvers ( lead-car following ) or tactical control maneuvers ( passing ) along with the distraction tasks in a driving simulator . response measures included driving performance and visual behavior . results revealed drivers ' ability to accommodate either visual or cognitive distractions in following tasks but not in passing . the simultaneous distraction condition led to the greatest decrement in performance . findings support the need to assess the impacts of in-vehicle distraction on different levels of driving control . future study should investigate driver distraction under strategic control .
24,930,178
[ "OBJECTIVE", "OBJECTIVE", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the paramount phase iii trial showed that maintenance pemetrexed after pemetrexed plus cisplatin induction was well tolerated and effective for patients with advanced nonsquamous non-small-cell lung cancer .", "approximately @ % of patients receiving maintenance therapy in this study were @ years of age or older .", "here we report efficacy and safety results from the paramount study for elderly ( @ years ) and non-elderly ( < @ years ) patients .", "final efficacy and safety data from the paramount study were analyzed post hoc using subgroup analyses for elderly and non-elderly patients .", "the median age was @ years in the elderly subgroup ( n = @ ) and @ years in the non-elderly subgroup ( n = @ ) .", "subgroups had similar baseline characteristics , except for a higher percentage of males and patients with a performance status of one in the elderly subgroup .", "for elderly patients , the median pfs was @ months for pemetrexed and @ months for placebo ; the median os was @ months for pemetrexed and @ months for placebo .", "for non-elderly patients , the median pfs was @ months for pemetrexed and @ months for placebo ; the median os was @ months for pemetrexed and @ months for placebo .", "elderly patients experienced similar levels of low-grade toxicities , but had a higher percentage of grade @/@ anemia and neutropenia than non-elderly patients , although importantly , this did not translate into increased febrile neutropenia .", "continuation maintenance pemetrexed had comparable survival and toxicity profiles in the elderly and non-elderly subgroups .", "however , grade @/@ anemia and neutropenia were numerically higher for elderly patients ." ]
the paramount phase iii trial showed that maintenance pemetrexed after pemetrexed plus cisplatin induction was well tolerated and effective for patients with advanced nonsquamous non-small-cell lung cancer . approximately @ % of patients receiving maintenance therapy in this study were @ years of age or older . here we report efficacy and safety results from the paramount study for elderly ( @ years ) and non-elderly ( < @ years ) patients . final efficacy and safety data from the paramount study were analyzed post hoc using subgroup analyses for elderly and non-elderly patients . the median age was @ years in the elderly subgroup ( n = @ ) and @ years in the non-elderly subgroup ( n = @ ) . subgroups had similar baseline characteristics , except for a higher percentage of males and patients with a performance status of one in the elderly subgroup . for elderly patients , the median pfs was @ months for pemetrexed and @ months for placebo ; the median os was @ months for pemetrexed and @ months for placebo . for non-elderly patients , the median pfs was @ months for pemetrexed and @ months for placebo ; the median os was @ months for pemetrexed and @ months for placebo . elderly patients experienced similar levels of low-grade toxicities , but had a higher percentage of grade @/@ anemia and neutropenia than non-elderly patients , although importantly , this did not translate into increased febrile neutropenia . continuation maintenance pemetrexed had comparable survival and toxicity profiles in the elderly and non-elderly subgroups . however , grade @/@ anemia and neutropenia were numerically higher for elderly patients .
24,926,544
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "ticagrelor is a reversibly binding and selective p@y@ - receptor antagonist approved for the prevention of atherothrombotic events in patients with acute coronary syndromes .", "as bleeding events remain a hazard with antiplatelet therapy , this study investigated the effect of the vasopressin agonist , desmopressin , on ticagrelor-induced bleeding time prolongation .", "desmopressin has previously been shown to improve primary haemostasis and is widely used as first-line therapy for individuals with bleeding disorders .", "in a randomized , double-blind , @-period crossover study , healthy volunteers received ticagrelor ( @mg loading dose ; @mgbid ) for @days .", "on day @ , desmopressin ( @g/kg ) or saline intravenous infusions were administered .", "the impact of desmopressin on bleeding time , inhibition of platelet aggregation ( ipa ) , platelet function and ticagrelor pharmacokinetic parameters was investigated .", "twenty-one volunteers ( @ % male ) were enrolled .", "median -lsb- range -rsb- bleeding times were slightly reduced with ticagrelor plus desmopressin compared with ticagrelor alone ( @ -lsb- @-@ -rsb- vs. @ -lsb- @-@ -rsb- min at @h ) .", "median reductions in bleeding time from baseline were generally similar between ticagrelor plus desmopressin compared with ticagrelor alone at all time points .", "co-administration of desmopressin had no impact on ipa , although platelet reactivity was significantly increased ( von willebrand factor antigen : gls mean auec was @ % .", "h for ticagrelor plus desmopressin compared with @ % .", "h for ticagrelor alone ) .", "desmopressin did not influence the pharmacokinetics of ticagrelor .", "desmopressin had no significant effect on bleeding time or inhibition of platelet aggregation by ticagrelor , although primary haemostatic activity was significantly increased .", "ticagrelor pharmacokinetic parameters were not affected by co-administration with desmopressin .", "therefore , desmopressin is unlikely to be an effective therapeutic agent for control of the potential bleeding events associated with ticagrelor ." ]
ticagrelor is a reversibly binding and selective p@y@ - receptor antagonist approved for the prevention of atherothrombotic events in patients with acute coronary syndromes . as bleeding events remain a hazard with antiplatelet therapy , this study investigated the effect of the vasopressin agonist , desmopressin , on ticagrelor-induced bleeding time prolongation . desmopressin has previously been shown to improve primary haemostasis and is widely used as first-line therapy for individuals with bleeding disorders . in a randomized , double-blind , @-period crossover study , healthy volunteers received ticagrelor ( @mg loading dose ; @mgbid ) for @days . on day @ , desmopressin ( @g/kg ) or saline intravenous infusions were administered . the impact of desmopressin on bleeding time , inhibition of platelet aggregation ( ipa ) , platelet function and ticagrelor pharmacokinetic parameters was investigated . twenty-one volunteers ( @ % male ) were enrolled . median -lsb- range -rsb- bleeding times were slightly reduced with ticagrelor plus desmopressin compared with ticagrelor alone ( @ -lsb- @-@ -rsb- vs. @ -lsb- @-@ -rsb- min at @h ) . median reductions in bleeding time from baseline were generally similar between ticagrelor plus desmopressin compared with ticagrelor alone at all time points . co-administration of desmopressin had no impact on ipa , although platelet reactivity was significantly increased ( von willebrand factor antigen : gls mean auec was @ % . h for ticagrelor plus desmopressin compared with @ % . h for ticagrelor alone ) . desmopressin did not influence the pharmacokinetics of ticagrelor . desmopressin had no significant effect on bleeding time or inhibition of platelet aggregation by ticagrelor , although primary haemostatic activity was significantly increased . ticagrelor pharmacokinetic parameters were not affected by co-administration with desmopressin . therefore , desmopressin is unlikely to be an effective therapeutic agent for control of the potential bleeding events associated with ticagrelor .
24,444,280
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "sedation with dexmedetomidine may facilitate ventilator liberation and limit the occurrence of delirium .", "no trial has assessed patient recall or the development of psychological outcomes after dexmedetomidine sedation .", "this pilot study evaluated whether transitioning benzodiazepine sedation to dexmedetomidine alters patient recall and the incidence of anxiety , depression , or acute stress disorder ( asd ) .", "this investigation was a randomized , double-blind , single-center study .", "existing continuous benzodiazepine sedation was converted to dexmedetomidine or midazolam when patients qualified for daily awakenings .", "sedation was titrated to achieve riker sedation agitation scores of @ to @ .", "the intensive care unit ( icu ) stressful experiences questionnaire , hospital anxiety and depression scale , and the impact of event scale-revised were administered before hospital discharge to assess recall , anxiety , depression , and manifestations of asd .", "a total of @ patients received dexmedetomidine , and @ patients received midazolam .", "median dosing was @ g/kg/h for @ days for dexmedetomidine and @ mg/h for @ days for midazolam .", "attainment of goal sedation and analgesia was similar ; however , more dexmedetomidine patients experienced agitation and pain .", "the median duration of mechanical ventilation from study drug initiation to extubation was @ days in dexmedetomidine patients and @ days in midazolam patients .", "dexmedetomidine patients remembered @ experiences compared with @ in midazolam patients ( p = @ ) .", "rates of anxiety and depression were similar .", "in all , @ ( @ % ) dexmedetomidine patients and @ ( @ % ) midazolam patient manifested asd ( p = @ ) , and @ dexmedetomidine patient and @ midazolam patients developed new-onset delirium ( p = @ ) .", "hypotension occurred in @ ( @ % ) dexmedotomidine patients and @ ( @ % ) midazolam patients ( p = @ ) .", "transitioning benzodiazepine sedation to dexmedetomidine when patients qualify for daily awakenings may reduce the development of delirium and facilitate remembrance of icu experiences but may lead to manifestations of asd .", "monitoring hypotension is required for both the sedatives .", "additional comparative studies focusing on the long-term impact of icu recall and psychological outcomes are needed ." ]
sedation with dexmedetomidine may facilitate ventilator liberation and limit the occurrence of delirium . no trial has assessed patient recall or the development of psychological outcomes after dexmedetomidine sedation . this pilot study evaluated whether transitioning benzodiazepine sedation to dexmedetomidine alters patient recall and the incidence of anxiety , depression , or acute stress disorder ( asd ) . this investigation was a randomized , double-blind , single-center study . existing continuous benzodiazepine sedation was converted to dexmedetomidine or midazolam when patients qualified for daily awakenings . sedation was titrated to achieve riker sedation agitation scores of @ to @ . the intensive care unit ( icu ) stressful experiences questionnaire , hospital anxiety and depression scale , and the impact of event scale-revised were administered before hospital discharge to assess recall , anxiety , depression , and manifestations of asd . a total of @ patients received dexmedetomidine , and @ patients received midazolam . median dosing was @ g/kg/h for @ days for dexmedetomidine and @ mg/h for @ days for midazolam . attainment of goal sedation and analgesia was similar ; however , more dexmedetomidine patients experienced agitation and pain . the median duration of mechanical ventilation from study drug initiation to extubation was @ days in dexmedetomidine patients and @ days in midazolam patients . dexmedetomidine patients remembered @ experiences compared with @ in midazolam patients ( p = @ ) . rates of anxiety and depression were similar . in all , @ ( @ % ) dexmedetomidine patients and @ ( @ % ) midazolam patient manifested asd ( p = @ ) , and @ dexmedetomidine patient and @ midazolam patients developed new-onset delirium ( p = @ ) . hypotension occurred in @ ( @ % ) dexmedotomidine patients and @ ( @ % ) midazolam patients ( p = @ ) . transitioning benzodiazepine sedation to dexmedetomidine when patients qualify for daily awakenings may reduce the development of delirium and facilitate remembrance of icu experiences but may lead to manifestations of asd . monitoring hypotension is required for both the sedatives . additional comparative studies focusing on the long-term impact of icu recall and psychological outcomes are needed .
24,227,448
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "we investigated the efficacy of concurrent chemoradiotherapy ( ccrt ) over radiotherapy ( rt ) in chinese patients with locally advanced cervical carcinoma .", "between january @ and january @ , @ patients with squamous cell carcinoma of the cervix were included in the study : @ in arm a ( ccrt with @ mg/m@ cisplatin for @ days ) and @ in arm b ( rt ) .", "the overall response rate was the primary endpoint .", "the secondary endpoints included overall survival , progression-free survival , and toxicity .", "the @-year overall response rate was @ % and @ % for the ccrt and rt arms , respectively , and the difference was statistically significant , while the median overall survival was @ months ( range @-@ months ) and @ months ( range @-@ months ) , respectively ( p = @ ) .", "in addition , the median progression-free survival for ccrt was @ months ( range @-@ months ) , whereas it was @ months ( range @-@ months ) for the rt arm ( p = @ ) .", "the toxicity profile , both acute and late , was comparable in both arms .", "in summary , we demonstrate that ccrt was effective and better tolerated than rt alone in chinese patients with locally advanced cervical carcinoma .", "chinese clinical trials register : chictr-trc-@ ." ]
we investigated the efficacy of concurrent chemoradiotherapy ( ccrt ) over radiotherapy ( rt ) in chinese patients with locally advanced cervical carcinoma . between january @ and january @ , @ patients with squamous cell carcinoma of the cervix were included in the study : @ in arm a ( ccrt with @ mg/m@ cisplatin for @ days ) and @ in arm b ( rt ) . the overall response rate was the primary endpoint . the secondary endpoints included overall survival , progression-free survival , and toxicity . the @-year overall response rate was @ % and @ % for the ccrt and rt arms , respectively , and the difference was statistically significant , while the median overall survival was @ months ( range @-@ months ) and @ months ( range @-@ months ) , respectively ( p = @ ) . in addition , the median progression-free survival for ccrt was @ months ( range @-@ months ) , whereas it was @ months ( range @-@ months ) for the rt arm ( p = @ ) . the toxicity profile , both acute and late , was comparable in both arms . in summary , we demonstrate that ccrt was effective and better tolerated than rt alone in chinese patients with locally advanced cervical carcinoma . chinese clinical trials register : chictr-trc-@ .
25,245,218
[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]
[ "to investigate an effectiveness of walking exercise program applying the theory of planned behavior in people at risk of hypertension in samut sakorn province .", "the present study is a quasi-experimental research .", "the inclusion criteria were people aged @-@ years old , systolic blood pressure @-@ mmhg , and diastolic blood pressure @-@ mmhg .", "participants were randomly selected into the experimental group ( n = @ ) and the comparison group ( n = @ ) .", "the experimental group received activities including health information , benefits of walking exercise , group discussion in exercise barriers , modeling and experience exchange , walking exercise practice , and practice on using walking monitoring booklet at the baseline and the @nd week , whereas the comparison group received only health information and the booklet practice at the beginning of the intervention .", "data were collected by self-administered questionnaires at the baseline , @nd week , and @th week .", "statistical analysis was performed using chi-square , independent t-test , and repeated measures anova .", "the experimental group made significant improvements in attitude towards walking exercise , perceived behavior control , subjective norm , walking exercise intention , and walking exercise over time ( p < @ ) .", "however , no statistically significant differences between the experimental and the comparison groups were found in subjective norm , systolic and diastolic blood pressure from baseline to the @th week .", "the experimental group had a significant higher mean difference score of attitude towards walking exercise , perceived behavior control , walking exercise intention , walking exercise , weight , and bmi compared to those in the comparison group ( p < @ ) .", "subjective norm scores in the experimental group were more likely to increase from baseline to the @th week , but not a significant difference .", "walking exercise programs applying the theory of planned behavior should be recommended in people at risk of hypertension .", "health professionals should also be motivated to practice with this program ." ]
to investigate an effectiveness of walking exercise program applying the theory of planned behavior in people at risk of hypertension in samut sakorn province . the present study is a quasi-experimental research . the inclusion criteria were people aged @-@ years old , systolic blood pressure @-@ mmhg , and diastolic blood pressure @-@ mmhg . participants were randomly selected into the experimental group ( n = @ ) and the comparison group ( n = @ ) . the experimental group received activities including health information , benefits of walking exercise , group discussion in exercise barriers , modeling and experience exchange , walking exercise practice , and practice on using walking monitoring booklet at the baseline and the @nd week , whereas the comparison group received only health information and the booklet practice at the beginning of the intervention . data were collected by self-administered questionnaires at the baseline , @nd week , and @th week . statistical analysis was performed using chi-square , independent t-test , and repeated measures anova . the experimental group made significant improvements in attitude towards walking exercise , perceived behavior control , subjective norm , walking exercise intention , and walking exercise over time ( p < @ ) . however , no statistically significant differences between the experimental and the comparison groups were found in subjective norm , systolic and diastolic blood pressure from baseline to the @th week . the experimental group had a significant higher mean difference score of attitude towards walking exercise , perceived behavior control , walking exercise intention , walking exercise , weight , and bmi compared to those in the comparison group ( p < @ ) . subjective norm scores in the experimental group were more likely to increase from baseline to the @th week , but not a significant difference . walking exercise programs applying the theory of planned behavior should be recommended in people at risk of hypertension . health professionals should also be motivated to practice with this program .
24,851,582
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "alcohol consumption has substantially increased in china during the last @ decades .", "socioeconomic status ( ses ) most likely influences the development of alcoholic liver disease ( ald ) in chinese people who excessively consume alcohol .", "at the present time , however , little information is available in this field .", "the objectives of this study were to investigate the population-based prevalence of ald and to identify the correlation of socioeconomics with the development of ald .", "a cross-sectional survey was conducted in @,@ individuals who resided in shandong province and were over @ years old in @ using a randomized multistage clustered sampling approach .", "among these subjects , @,@ ( @ % ) were interviewed .", "questionnaires covered demographic characteristic , medical history , current medication , and health-relevant behavior , particularly alcohol consumption , dietary habit , and physical activity .", "anthropometric measurements , biochemical tests , and abdominal ultrasonography were also performed .", "among the @,@ subjects , @ ( @ % ) were diagnosed with ald .", "the prevalence rate was significantly higher in males than in females ( @ % in males vs. @ % in females , p < @ ) .", "in this population , the risk of ald was highest in the @ - to @-year-old group .", "the incidence of ald was highest in individuals who had a high level of occupation .", "individuals who had received a low level of education had the highest incidence of ald .", "subjects with a low family income were more likely to have ald than did those with an abundant family income .", "currently , unmarried individuals had a higher incidence of ald in the overall population .", "ald is prevalent in north-eastern china .", "ses correlates with the development of ald .", "socioeconomic risk factors for ald in north-eastern china include male gender , middle age , currently unmarried , low level of education , low family income , and high level of occupation ." ]
alcohol consumption has substantially increased in china during the last @ decades . socioeconomic status ( ses ) most likely influences the development of alcoholic liver disease ( ald ) in chinese people who excessively consume alcohol . at the present time , however , little information is available in this field . the objectives of this study were to investigate the population-based prevalence of ald and to identify the correlation of socioeconomics with the development of ald . a cross-sectional survey was conducted in @,@ individuals who resided in shandong province and were over @ years old in @ using a randomized multistage clustered sampling approach . among these subjects , @,@ ( @ % ) were interviewed . questionnaires covered demographic characteristic , medical history , current medication , and health-relevant behavior , particularly alcohol consumption , dietary habit , and physical activity . anthropometric measurements , biochemical tests , and abdominal ultrasonography were also performed . among the @,@ subjects , @ ( @ % ) were diagnosed with ald . the prevalence rate was significantly higher in males than in females ( @ % in males vs. @ % in females , p < @ ) . in this population , the risk of ald was highest in the @ - to @-year-old group . the incidence of ald was highest in individuals who had a high level of occupation . individuals who had received a low level of education had the highest incidence of ald . subjects with a low family income were more likely to have ald than did those with an abundant family income . currently , unmarried individuals had a higher incidence of ald in the overall population . ald is prevalent in north-eastern china . ses correlates with the development of ald . socioeconomic risk factors for ald in north-eastern china include male gender , middle age , currently unmarried , low level of education , low family income , and high level of occupation .
24,428,769
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "when switching from usual brand cigarettes , very low nicotine content ( vlnc ) cigarettes lead to a reduction in the number of cigarettes smoked , toxicant exposure , withdrawal symptoms and dependence .", "one area that has been relatively unexplored is what factors might moderate the effects of vlnc cigarettes .", "this exploratory analysis focuses on sex differences in responses to vlnc cigarettes and nicotine replacement therapy .", "an exploratory secondary analysis of a randomized trial of @ participants ( @ % female , mean age @ years ) comparing a ) @-@ @ mg nicotine yield cigarettes ; b ) @ mg nicotine patch and @ ) @-@ @ nicotine yield cigarettes with @ mg nicotine patch was conducted .", "we focused on sex differences in product use , and impact of products on withdrawal response from usual brand cigarettes and abstinence by randomized group .", "the combination of vlnc cigarettes and nicotine patch was more effective in reducing use of vlnc cigarettes and withdrawal symptoms among males than females , whereas females were equally responsive to vlnc cigarettes with and without the nicotine patch .", "females were more likely to quit smoking than males when assigned to either of the conditions that incorporated the vlnc cigarettes ; however , males were more likely to quit smoking in the nicotine patch alone condition than females .", "sex of the smoker may be an important determinant for effects of vlnc cigarettes and nicotine patch .", "future large randomized trials to confirm these results are needed ." ]
when switching from usual brand cigarettes , very low nicotine content ( vlnc ) cigarettes lead to a reduction in the number of cigarettes smoked , toxicant exposure , withdrawal symptoms and dependence . one area that has been relatively unexplored is what factors might moderate the effects of vlnc cigarettes . this exploratory analysis focuses on sex differences in responses to vlnc cigarettes and nicotine replacement therapy . an exploratory secondary analysis of a randomized trial of @ participants ( @ % female , mean age @ years ) comparing a ) @-@ @ mg nicotine yield cigarettes ; b ) @ mg nicotine patch and @ ) @-@ @ nicotine yield cigarettes with @ mg nicotine patch was conducted . we focused on sex differences in product use , and impact of products on withdrawal response from usual brand cigarettes and abstinence by randomized group . the combination of vlnc cigarettes and nicotine patch was more effective in reducing use of vlnc cigarettes and withdrawal symptoms among males than females , whereas females were equally responsive to vlnc cigarettes with and without the nicotine patch . females were more likely to quit smoking than males when assigned to either of the conditions that incorporated the vlnc cigarettes ; however , males were more likely to quit smoking in the nicotine patch alone condition than females . sex of the smoker may be an important determinant for effects of vlnc cigarettes and nicotine patch . future large randomized trials to confirm these results are needed .
24,746,485
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]