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[ "current guidelines recommend at least @ hours of electrocardiographic ( ecg ) monitoring after an ischemic stroke to rule out atrial fibrillation .", "however , the most effective duration and type of monitoring have not been established , and the cause of ischemic stroke remains uncertain despite a complete diagnostic evaluation in @ to @ % of cases ( cryptogenic stroke ) .", "detection of atrial fibrillation after cryptogenic stroke has therapeutic implications .", "we conducted a randomized , controlled study of @ patients to assess whether long-term monitoring with an insertable cardiac monitor ( icm ) is more effective than conventional follow-up ( control ) for detecting atrial fibrillation in patients with cryptogenic stroke .", "patients @ years of age or older with no evidence of atrial fibrillation during at least @ hours of ecg monitoring underwent randomization within @ days after the index event .", "the primary end point was the time to first detection of atrial fibrillation ( lasting > @ seconds ) within @ months .", "among the secondary end points was the time to first detection of atrial fibrillation within @ months .", "data were analyzed according to the intention-to-treat principle .", "by @ months , atrial fibrillation had been detected in @ % of patients in the icm group ( @ patients ) versus @ % of patients in the control group ( @ patients ) ( hazard ratio , @ ; @ % confidence interval -lsb- ci -rsb- , @ to @ ; p < @ ) .", "by @ months , atrial fibrillation had been detected in @ % of patients in the icm group ( @ patients ) versus @ % of patients in the control group ( @ patients ) ( hazard ratio , @ ; @ % ci , @ to @ ; p < @ ) .", "ecg monitoring with an icm was superior to conventional follow-up for detecting atrial fibrillation after cryptogenic stroke .", "( funded by medtronic ; crystal af clinicaltrials.gov number , nct@ . )" ]
current guidelines recommend at least @ hours of electrocardiographic ( ecg ) monitoring after an ischemic stroke to rule out atrial fibrillation . however , the most effective duration and type of monitoring have not been established , and the cause of ischemic stroke remains uncertain despite a complete diagnostic evaluation in @ to @ % of cases ( cryptogenic stroke ) . detection of atrial fibrillation after cryptogenic stroke has therapeutic implications . we conducted a randomized , controlled study of @ patients to assess whether long-term monitoring with an insertable cardiac monitor ( icm ) is more effective than conventional follow-up ( control ) for detecting atrial fibrillation in patients with cryptogenic stroke . patients @ years of age or older with no evidence of atrial fibrillation during at least @ hours of ecg monitoring underwent randomization within @ days after the index event . the primary end point was the time to first detection of atrial fibrillation ( lasting > @ seconds ) within @ months . among the secondary end points was the time to first detection of atrial fibrillation within @ months . data were analyzed according to the intention-to-treat principle . by @ months , atrial fibrillation had been detected in @ % of patients in the icm group ( @ patients ) versus @ % of patients in the control group ( @ patients ) ( hazard ratio , @ ; @ % confidence interval -lsb- ci -rsb- , @ to @ ; p < @ ) . by @ months , atrial fibrillation had been detected in @ % of patients in the icm group ( @ patients ) versus @ % of patients in the control group ( @ patients ) ( hazard ratio , @ ; @ % ci , @ to @ ; p < @ ) . ecg monitoring with an icm was superior to conventional follow-up for detecting atrial fibrillation after cryptogenic stroke . ( funded by medtronic ; crystal af clinicaltrials.gov number , nct@ . )
24,963,567
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "piriformis muscle injections are most often performed using fluoroscopic guidance ; however , ultrasound ( us ) guidance has recently been described extensively in the literature .", "no direct comparisons between the @ techniques have been performed .", "our objective was to compare the efficacy and efficiency of fluoroscopic - and us-guided techniques .", "a randomized , comparative trial was carried out to compare the @ techniques .", "twenty-eight patients with a diagnosis of piriformis syndrome , based on history and physical examination , who had failed conservative treatment were enrolled in the study .", "patients were randomized to receive the injection either via us or fluoroscopy .", "injections consisted of @ ml of @ % lidocaine with @ mg of triamcinalone .", "the primary outcome measure was numeric pain score , and secondary outcome measures included functional status as measured by the multidimensional pain inventory , patient satisfaction as measured by the patient global impression of change scale , and procedure timing characteristics .", "outcome data were measured preprocedure , immediately postprocedure , and @ to @ weeks and @ months postprocedure .", "we found no statistically significant differences in numeric pain scores , patient satisfaction , procedure timing characteristics , or most functional outcomes when comparing the @ techniques .", "statistically significant differences between the @ techniques were found with respect to the outcome measures of household chores and outdoor work .", "ultrasound-guided piriformis injections provide similar outcomes to fluoroscopically guided injections without differences in imaging , needling , or overall procedural times ." ]
piriformis muscle injections are most often performed using fluoroscopic guidance ; however , ultrasound ( us ) guidance has recently been described extensively in the literature . no direct comparisons between the @ techniques have been performed . our objective was to compare the efficacy and efficiency of fluoroscopic - and us-guided techniques . a randomized , comparative trial was carried out to compare the @ techniques . twenty-eight patients with a diagnosis of piriformis syndrome , based on history and physical examination , who had failed conservative treatment were enrolled in the study . patients were randomized to receive the injection either via us or fluoroscopy . injections consisted of @ ml of @ % lidocaine with @ mg of triamcinalone . the primary outcome measure was numeric pain score , and secondary outcome measures included functional status as measured by the multidimensional pain inventory , patient satisfaction as measured by the patient global impression of change scale , and procedure timing characteristics . outcome data were measured preprocedure , immediately postprocedure , and @ to @ weeks and @ months postprocedure . we found no statistically significant differences in numeric pain scores , patient satisfaction , procedure timing characteristics , or most functional outcomes when comparing the @ techniques . statistically significant differences between the @ techniques were found with respect to the outcome measures of household chores and outdoor work . ultrasound-guided piriformis injections provide similar outcomes to fluoroscopically guided injections without differences in imaging , needling , or overall procedural times .
24,509,422
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the cost implications of the outcome reduction with an initial glargine intervention ( origin ) trial were evaluated using a prespecified analysis plan .", "purchasing power parity-adjusted country-specific costs were applied to consumed healthcare resources by participants from each country .", "subgroup analyses were conducted on subgroups based on baseline metabolic status and diabetes duration .", "the total undiscounted cost per participant in the insulin glargine arm was $ @,@ ( $ @,@ to $ @,@ ) versus $ @,@ ( $ @,@ to $ @,@ ) for standard care , an increase of $ @ ( $ @ to $ @ ; p < @ ) ; the discounted increase was $ @ ( $ @ to $ @ ; p < @ ) .", "the greater number of mainly generic oral anti-diabetic agents in the standard group partially offset the higher cost of basal insulin glargine .", "as the trial progressed and the standard group required more anti-diabetic medications , the annual cost difference decreased , reaching $ @ ( - $ @ to $ @ ) in the last year .", "the subgroup whose baseline diabetes duration was @ years achieved cost-savings during the trial .", "from a global perspective basal insulin glargine use in origin incurred greater costs than standard care using older generic drugs .", "nevertheless , the cost difference fell with time such that the intervention was cost-neutral by the last year ." ]
the cost implications of the outcome reduction with an initial glargine intervention ( origin ) trial were evaluated using a prespecified analysis plan . purchasing power parity-adjusted country-specific costs were applied to consumed healthcare resources by participants from each country . subgroup analyses were conducted on subgroups based on baseline metabolic status and diabetes duration . the total undiscounted cost per participant in the insulin glargine arm was $ @,@ ( $ @,@ to $ @,@ ) versus $ @,@ ( $ @,@ to $ @,@ ) for standard care , an increase of $ @ ( $ @ to $ @ ; p < @ ) ; the discounted increase was $ @ ( $ @ to $ @ ; p < @ ) . the greater number of mainly generic oral anti-diabetic agents in the standard group partially offset the higher cost of basal insulin glargine . as the trial progressed and the standard group required more anti-diabetic medications , the annual cost difference decreased , reaching $ @ ( - $ @ to $ @ ) in the last year . the subgroup whose baseline diabetes duration was @ years achieved cost-savings during the trial . from a global perspective basal insulin glargine use in origin incurred greater costs than standard care using older generic drugs . nevertheless , the cost difference fell with time such that the intervention was cost-neutral by the last year .
24,684,774
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "social cognition and interaction training ( scit ) has shown promise in improving consumers ' social cognition and functioning , in both inpatient and outpatient settings .", "this randomized controlled trial examined the effectiveness of scit among persons with serious mental illness living in community settings in israel .", "fifty-five participants in social-mentoring services were assigned randomly to scit with social mentoring or to social mentoring only .", "emotion recognition , theory of mind , attributional bias , and social functioning were assessed at baseline ( february @ ) and about six months later , upon completion of the intervention .", "interactions between time of measurement and group were significant for theory of mind and social engagement .", "emotion recognition by the scit group improved significantly , but the time group interaction for this variable was not significant .", "this study provides preliminary evidence that scit plus social mentoring improves social cognition and functioning among persons with severe mental illness who are living in the community ." ]
social cognition and interaction training ( scit ) has shown promise in improving consumers ' social cognition and functioning , in both inpatient and outpatient settings . this randomized controlled trial examined the effectiveness of scit among persons with serious mental illness living in community settings in israel . fifty-five participants in social-mentoring services were assigned randomly to scit with social mentoring or to social mentoring only . emotion recognition , theory of mind , attributional bias , and social functioning were assessed at baseline ( february @ ) and about six months later , upon completion of the intervention . interactions between time of measurement and group were significant for theory of mind and social engagement . emotion recognition by the scit group improved significantly , but the time group interaction for this variable was not significant . this study provides preliminary evidence that scit plus social mentoring improves social cognition and functioning among persons with severe mental illness who are living in the community .
24,687,108
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "health-related and disease-specific quality of life ( hrqol ) has been increasingly valued as relevant clinical parameter in cystic fibrosis ( cf ) clinical care and clinical trials .", "hrqol measures should assess - among other domains - daily functioning from a patient 's perspective .", "however , validation studies for the most frequently used hrqol questionnaire in cf , the cystic fibrosis questionnaire ( cfq ) , have not included measures of physical activity or fitness .", "the objective of this study was , therefore , to determine the cross-sectional and longitudinal relationships between hrqol , physical activity and fitness in patients with cf.", "baseline ( n = @ ) and @-month follow-up data ( n = @ ) from patients with cf ( age @ years , fev@ @ % ) were analysed .", "patients participated in two multi-centre exercise intervention studies with identical assessment methodology .", "outcome variables included hrqol ( german revised multi-dimensional disease-specific cfq ( cfq-r ) ) , body composition , pulmonary function , physical activity , short-term muscle power , and aerobic fitness by peak oxygen uptake and aerobic power .", "peak oxygen uptake was positively related to @ of @ hrqol scales cross-sectionally ( r = @-@ @ ) .", "muscle power ( r = @-@ @ ) and peak aerobic power ( r = @-@ @ ) were positively related to @ scales each , and reported physical activity to @ scale ( r = @ ) .", "changes in hrqol-scores were directly and significantly related to changes in reported activity ( r = @-@ @ ) , peak aerobic power ( r = @-@ @ ) , and peak oxygen uptake ( r = @-@ @ ) in @ scales each .", "established associates of hrqol such as fev@ or body mass index correlated positively with fewer scales ( all @ < r < @ ) .", "hrqol was associated with physical fitness , especially aerobic fitness , and to a lesser extent with reported physical activity .", "these findings underline the importance of physical fitness for hrqol in cf and provide an additional rationale for exercise testing in this population .", "clinicaltrials.gov , nct@ ." ]
health-related and disease-specific quality of life ( hrqol ) has been increasingly valued as relevant clinical parameter in cystic fibrosis ( cf ) clinical care and clinical trials . hrqol measures should assess - among other domains - daily functioning from a patient 's perspective . however , validation studies for the most frequently used hrqol questionnaire in cf , the cystic fibrosis questionnaire ( cfq ) , have not included measures of physical activity or fitness . the objective of this study was , therefore , to determine the cross-sectional and longitudinal relationships between hrqol , physical activity and fitness in patients with cf. baseline ( n = @ ) and @-month follow-up data ( n = @ ) from patients with cf ( age @ years , fev@ @ % ) were analysed . patients participated in two multi-centre exercise intervention studies with identical assessment methodology . outcome variables included hrqol ( german revised multi-dimensional disease-specific cfq ( cfq-r ) ) , body composition , pulmonary function , physical activity , short-term muscle power , and aerobic fitness by peak oxygen uptake and aerobic power . peak oxygen uptake was positively related to @ of @ hrqol scales cross-sectionally ( r = @-@ @ ) . muscle power ( r = @-@ @ ) and peak aerobic power ( r = @-@ @ ) were positively related to @ scales each , and reported physical activity to @ scale ( r = @ ) . changes in hrqol-scores were directly and significantly related to changes in reported activity ( r = @-@ @ ) , peak aerobic power ( r = @-@ @ ) , and peak oxygen uptake ( r = @-@ @ ) in @ scales each . established associates of hrqol such as fev@ or body mass index correlated positively with fewer scales ( all @ < r < @ ) . hrqol was associated with physical fitness , especially aerobic fitness , and to a lesser extent with reported physical activity . these findings underline the importance of physical fitness for hrqol in cf and provide an additional rationale for exercise testing in this population . clinicaltrials.gov , nct@ .
24,571,729
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "to compare the efficacy and safety of single-dose bimatoprost @ % / timolol @ % preservative-free ( pf ) ophthalmic solution with bimatoprost @ % / timolol @ % ophthalmic solution in patients with open-angle glaucoma or ocular hypertension .", "in this multicentre , randomised , parallel-group study , patients were randomised to bimatoprost/timolol pf or bimatoprost/timolol once daily in the morning for @ weeks .", "primary efficacy endpoints , reflecting differing regional regulatory requirements , included change from baseline in worse eye intraocular pressure ( iop ) in the per-protocol population at week @ , and the average eye iop at weeks @ , @ and @ in the intent-to-treat population .", "@ patients were randomised ( @ to bimatoprost/timolol pf ; @ to bimatoprost/timolol ) ; @ % completed the study .", "both treatment groups showed statistically and clinically significant mean decreases from baseline in worse eye iop and in average eye iop at all follow-up time points ( p < @ ) .", "bimatoprost/timolol pf met all pre-established criteria for non-inferiority and equivalence to bimatoprost/timolol .", "ocular adverse events were similar between treatment groups , with conjunctival hyperaemia being the most frequent .", "most were mild or moderate in severity .", "bimatoprost/timolol pf demonstrated non-inferiority and equivalence in iop lowering compared with bimatoprost/timolol , with no significant differences in safety and tolerability .", "nct@ ." ]
to compare the efficacy and safety of single-dose bimatoprost @ % / timolol @ % preservative-free ( pf ) ophthalmic solution with bimatoprost @ % / timolol @ % ophthalmic solution in patients with open-angle glaucoma or ocular hypertension . in this multicentre , randomised , parallel-group study , patients were randomised to bimatoprost/timolol pf or bimatoprost/timolol once daily in the morning for @ weeks . primary efficacy endpoints , reflecting differing regional regulatory requirements , included change from baseline in worse eye intraocular pressure ( iop ) in the per-protocol population at week @ , and the average eye iop at weeks @ , @ and @ in the intent-to-treat population . @ patients were randomised ( @ to bimatoprost/timolol pf ; @ to bimatoprost/timolol ) ; @ % completed the study . both treatment groups showed statistically and clinically significant mean decreases from baseline in worse eye iop and in average eye iop at all follow-up time points ( p < @ ) . bimatoprost/timolol pf met all pre-established criteria for non-inferiority and equivalence to bimatoprost/timolol . ocular adverse events were similar between treatment groups , with conjunctival hyperaemia being the most frequent . most were mild or moderate in severity . bimatoprost/timolol pf demonstrated non-inferiority and equivalence in iop lowering compared with bimatoprost/timolol , with no significant differences in safety and tolerability . nct@ .
24,667,994
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]
[ "current guidelines recommend treatment of significant coronary artery disease by concomitant coronary artery bypass grafting ( cabg ) in patients undergoing surgical aortic valve replacement .", "however there is no consensus as to how best to treat coronary disease in high-risk patients requiring transcatheter aortic valve implantation ( tavi ) .", "the percutaneous coronary intervention prior to transcatheter aortic valve implantation ( activation ) trial is a randomized , controlled open-label trial of @ patients randomized to treatment of significant coronary artery disease by percutaneous coronary intervention ( pci - test arm ) or no pci ( control arm ) .", "significant coronary disease is defined as @ lesion of @ % severity in a major epicardial vessel or @ % in a vein graft or protected left main stem lesion .", "the trial tests the hypothesis that the strategy of performing pre-tavi pci is non-inferior to not treating such coronary stenoses with pci prior to tavi , with a composite primary outcome of @-month mortality and rehospitalization .", "secondary outcomes include efficacy end-points such as @-day mortality , safety endpoints including bleeding , burden of symptoms , and quality of life ( assessed using the seattle angina questionnaire and the kansas city cardiomyopathy questionnaire ) .", "in conclusion , we hope that using a definition of coronary artery disease severity closer to that used in everyday practice by interventional cardiologists - rather than the @ % severity used in surgical guidelines - will provide robust evidence to direct guidelines regarding tavi therapy and improve its safety and efficacy profile of this developing technique .", "isrctn@ , http://www.controlled-trials.com/isrctn@ ( registered @ november @ ) ." ]
current guidelines recommend treatment of significant coronary artery disease by concomitant coronary artery bypass grafting ( cabg ) in patients undergoing surgical aortic valve replacement . however there is no consensus as to how best to treat coronary disease in high-risk patients requiring transcatheter aortic valve implantation ( tavi ) . the percutaneous coronary intervention prior to transcatheter aortic valve implantation ( activation ) trial is a randomized , controlled open-label trial of @ patients randomized to treatment of significant coronary artery disease by percutaneous coronary intervention ( pci - test arm ) or no pci ( control arm ) . significant coronary disease is defined as @ lesion of @ % severity in a major epicardial vessel or @ % in a vein graft or protected left main stem lesion . the trial tests the hypothesis that the strategy of performing pre-tavi pci is non-inferior to not treating such coronary stenoses with pci prior to tavi , with a composite primary outcome of @-month mortality and rehospitalization . secondary outcomes include efficacy end-points such as @-day mortality , safety endpoints including bleeding , burden of symptoms , and quality of life ( assessed using the seattle angina questionnaire and the kansas city cardiomyopathy questionnaire ) . in conclusion , we hope that using a definition of coronary artery disease severity closer to that used in everyday practice by interventional cardiologists - rather than the @ % severity used in surgical guidelines - will provide robust evidence to direct guidelines regarding tavi therapy and improve its safety and efficacy profile of this developing technique . isrctn@ , http://www.controlled-trials.com/isrctn@ ( registered @ november @ ) .
25,059,340
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "BACKGROUND" ]
[ "some characteristics of assessments exert a strong influence on how students study .", "understanding these pre-assessment learning effects is of key importance to the designing of medical assessments that foster students ' reasoning abilities .", "perceptions of the task demands of an assessment significantly influence students ' cognitive processes .", "however , why and how certain tasks positively ` drive ' learning remain unknown .", "medical tasks can be assessed as coherent meaningful whole tasks ( e.g. examining a patient based on his complaint to find the diagnosis ) or can be divided into simpler part tasks ( e.g. demonstrating the physical examination of a pre-specified disease ) .", "comparing the benefits of whole-task and part-task assessments in a randomised controlled experiment could guide the design of ` assessments for learning ' .", "the purpose of this study was to determine whether the knowledge that an objective structured clinical examination ( osce ) will contain whole tasks , as opposed to part tasks , increases the use of diagnostic reasoning by medical students when they study for this assessment .", "in this randomised , controlled , mixed-methods experiment , @ medical students were randomly paired and filmed while studying together for two imminent physical examination osce stations .", "each @-minute study period began with video cues and ended with a questionnaire on cognitive loads .", "cues disclosed either a part-task osce station ( examination of a healthy patient ) or a whole-task osce station ( hypothesis-driven physical examination -lsb- hdpe -rsb- ) .", "in a crossover design , sequences were randomised for both task and content ( shoulder or spine ) .", "two blinded and independent authors scored all @ videos in distinct randomised orders , listening to participants studying freely .", "mentioning a diagnosis in association with a sign was scored as a backward association , and the opposite was scored as a forward association ; both revealed the use of diagnostic reasoning .", "qualitative data were obtained through group interviews .", "studying for whole-task osce stations resulted in a greater use of diagnostic reasoning .", "qualitative data triangulate these findings and show the precedence of cues sourced from the ` student grapevine ' .", "in comparison with ` traditional ' part-task osces , whole-task osces like the hdpe increase students ' use of diagnostic reasoning during study time ." ]
some characteristics of assessments exert a strong influence on how students study . understanding these pre-assessment learning effects is of key importance to the designing of medical assessments that foster students ' reasoning abilities . perceptions of the task demands of an assessment significantly influence students ' cognitive processes . however , why and how certain tasks positively ` drive ' learning remain unknown . medical tasks can be assessed as coherent meaningful whole tasks ( e.g. examining a patient based on his complaint to find the diagnosis ) or can be divided into simpler part tasks ( e.g. demonstrating the physical examination of a pre-specified disease ) . comparing the benefits of whole-task and part-task assessments in a randomised controlled experiment could guide the design of ` assessments for learning ' . the purpose of this study was to determine whether the knowledge that an objective structured clinical examination ( osce ) will contain whole tasks , as opposed to part tasks , increases the use of diagnostic reasoning by medical students when they study for this assessment . in this randomised , controlled , mixed-methods experiment , @ medical students were randomly paired and filmed while studying together for two imminent physical examination osce stations . each @-minute study period began with video cues and ended with a questionnaire on cognitive loads . cues disclosed either a part-task osce station ( examination of a healthy patient ) or a whole-task osce station ( hypothesis-driven physical examination -lsb- hdpe -rsb- ) . in a crossover design , sequences were randomised for both task and content ( shoulder or spine ) . two blinded and independent authors scored all @ videos in distinct randomised orders , listening to participants studying freely . mentioning a diagnosis in association with a sign was scored as a backward association , and the opposite was scored as a forward association ; both revealed the use of diagnostic reasoning . qualitative data were obtained through group interviews . studying for whole-task osce stations resulted in a greater use of diagnostic reasoning . qualitative data triangulate these findings and show the precedence of cues sourced from the ` student grapevine ' . in comparison with ` traditional ' part-task osces , whole-task osces like the hdpe increase students ' use of diagnostic reasoning during study time .
25,626,751
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the interferon-free combination of the protease inhibitor abt-@ with ritonavir ( abt-@ / r ) and the ns@a inhibitor ombitasvir ( also known as abt-@ ) plus the nonnucleoside polymerase inhibitor dasabuvir ( also known as abt-@ ) and ribavirin has shown efficacy against the hepatitis c virus ( hcv ) in patients with hcv genotype @ infection .", "in this phase @ trial , we evaluated this regimen in previously untreated patients with hcv genotype @ infection and no cirrhosis .", "in this multicenter , randomized , double-blind , placebo-controlled trial , we assigned previously untreated patients with hcv genotype @ infection , in a @:@ ratio , to an active regimen consisting of a single-tablet coformulation of abt-@ / r-ombitasvir ( at a once-daily dose of @ mg of abt-@ , @ mg of ritonavir , and @ mg of ombitasvir ) , and dasabuvir ( @ mg twice daily ) with ribavirin ( in doses determined according to body weight ) ( group a ) or matching placebos ( group b ) .", "the patients received the study treatment during a @-week double-blind period .", "the primary end point was sustained virologic response at @ weeks after the end of treatment .", "the primary analysis compared the response rate in group a with the response rate ( @ % ) in a historical control group of previously untreated patients without cirrhosis who received telaprevir with peginterferon and ribavirin .", "adverse events occurring during the double-blind period were compared between group a and group b.", "a total of @ patients received at least one dose of the study drugs .", "the rate of sustained virologic response in group a was @ % ( @ % confidence interval , @ to @ ) , which was superior to the historical control rate .", "virologic failure during treatment and relapse after treatment occurred in @ % and @ % , respectively , of the patients in group a.", "the response rates in group a were @ % among patients with hcv genotype @a infection and @ % among those with hcv genotype @b infection .", "the rate of discontinuation due to adverse events was @ % in each study group .", "nausea , pruritus , insomnia , diarrhea , and asthenia occurred in significantly more patients in group a than in group b ( p < @ for all comparisons ) .", "reductions in the hemoglobin level were all of grade @ or @ ; reductions of grade @ and @ occurred in @ % and @ % , respectively , of the patients in group a , whereas grade @ reductions occurred in @ % of the patients in group b.", "in previously untreated patients with hcv genotype @ infection and no cirrhosis , a @-week multitargeted regimen of abt-@ / r-ombitasvir and dasabuvir with ribavirin was highly effective and was associated with a low rate of treatment discontinuation .", "( funded by abbvie ; sapphire-i clinicaltrials.gov number , nct@ . )" ]
the interferon-free combination of the protease inhibitor abt-@ with ritonavir ( abt-@ / r ) and the ns@a inhibitor ombitasvir ( also known as abt-@ ) plus the nonnucleoside polymerase inhibitor dasabuvir ( also known as abt-@ ) and ribavirin has shown efficacy against the hepatitis c virus ( hcv ) in patients with hcv genotype @ infection . in this phase @ trial , we evaluated this regimen in previously untreated patients with hcv genotype @ infection and no cirrhosis . in this multicenter , randomized , double-blind , placebo-controlled trial , we assigned previously untreated patients with hcv genotype @ infection , in a @:@ ratio , to an active regimen consisting of a single-tablet coformulation of abt-@ / r-ombitasvir ( at a once-daily dose of @ mg of abt-@ , @ mg of ritonavir , and @ mg of ombitasvir ) , and dasabuvir ( @ mg twice daily ) with ribavirin ( in doses determined according to body weight ) ( group a ) or matching placebos ( group b ) . the patients received the study treatment during a @-week double-blind period . the primary end point was sustained virologic response at @ weeks after the end of treatment . the primary analysis compared the response rate in group a with the response rate ( @ % ) in a historical control group of previously untreated patients without cirrhosis who received telaprevir with peginterferon and ribavirin . adverse events occurring during the double-blind period were compared between group a and group b. a total of @ patients received at least one dose of the study drugs . the rate of sustained virologic response in group a was @ % ( @ % confidence interval , @ to @ ) , which was superior to the historical control rate . virologic failure during treatment and relapse after treatment occurred in @ % and @ % , respectively , of the patients in group a. the response rates in group a were @ % among patients with hcv genotype @a infection and @ % among those with hcv genotype @b infection . the rate of discontinuation due to adverse events was @ % in each study group . nausea , pruritus , insomnia , diarrhea , and asthenia occurred in significantly more patients in group a than in group b ( p < @ for all comparisons ) . reductions in the hemoglobin level were all of grade @ or @ ; reductions of grade @ and @ occurred in @ % and @ % , respectively , of the patients in group a , whereas grade @ reductions occurred in @ % of the patients in group b. in previously untreated patients with hcv genotype @ infection and no cirrhosis , a @-week multitargeted regimen of abt-@ / r-ombitasvir and dasabuvir with ribavirin was highly effective and was associated with a low rate of treatment discontinuation . ( funded by abbvie ; sapphire-i clinicaltrials.gov number , nct@ . )
24,720,703
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "cognitive interventions increasingly complement psychopharmacological treatment to enhance symptomatic and functional outcome in schizophrenia .", "metacognitive training ( mct ) is targeted at cognitive biases involved in the pathogenesis of delusions .", "to examine the long-term efficacy of group mct for schizophrenia in order to explore whether previously established effects were sustained .", "a @-center , randomized , controlled , assessor-blind , parallel group trial was conducted .", "a total of @ inpatients or outpatients with dsm-iv diagnoses of schizophrenia spectrum disorders were enrolled .", "all patients were prescribed antipsychotic medication .", "the second follow-up assessment took place @ years later after the intervention phase was terminated .", "group mct targeting cognitive biases vs neuropsychological training ( cogpack ) .", "patients received a maximum of @ sessions .", "the primary outcome measure was a delusion score derived from the positive and negative syndrome scale ( panss ) .", "the panss positive syndrome and total scores , the psychotic symptom rating scales , the jumping to conclusions bias , self-esteem , and quality of life served as secondary outcome measures .", "the intention-to-treat analyses demonstrated that patients in the mct group had significantly greater reductions in the core panss delusion score , after @ years compared with the control group ( @partial = @ ; p = @ ) .", "among the secondary outcomes , the intention-to-treat analyses also demonstrated that patients in the mct group had significantly greater reductions in the panss positive syndrome score ( @partial = @ ; p = @ ) and the psychotic symptom rating scales delusion score ( @partial = @ ; p = @ ) .", "significant group differences at the @-year follow-up were also found on measures of self-esteem and quality of life , which did not distinguish groups at earlier assessment points .", "attention was improved in the neuropsychological training group relative to the mct group .", "the completion rate was @ % after @ years .", "metacognitive training demonstrated sustained effects in the reduction of delusions , which were over and above the effects of antipsychotic medication .", "moreover , there were some unanticipated ( `` sleeper '' ) effects as both self-esteem and quality of life were improved after @ years .", "effects on self-esteem and well-being were found even in the absence of an improvement on the jumping to conclusions bias .", "isrctn.org identifier : isrctn@ ." ]
cognitive interventions increasingly complement psychopharmacological treatment to enhance symptomatic and functional outcome in schizophrenia . metacognitive training ( mct ) is targeted at cognitive biases involved in the pathogenesis of delusions . to examine the long-term efficacy of group mct for schizophrenia in order to explore whether previously established effects were sustained . a @-center , randomized , controlled , assessor-blind , parallel group trial was conducted . a total of @ inpatients or outpatients with dsm-iv diagnoses of schizophrenia spectrum disorders were enrolled . all patients were prescribed antipsychotic medication . the second follow-up assessment took place @ years later after the intervention phase was terminated . group mct targeting cognitive biases vs neuropsychological training ( cogpack ) . patients received a maximum of @ sessions . the primary outcome measure was a delusion score derived from the positive and negative syndrome scale ( panss ) . the panss positive syndrome and total scores , the psychotic symptom rating scales , the jumping to conclusions bias , self-esteem , and quality of life served as secondary outcome measures . the intention-to-treat analyses demonstrated that patients in the mct group had significantly greater reductions in the core panss delusion score , after @ years compared with the control group ( @partial = @ ; p = @ ) . among the secondary outcomes , the intention-to-treat analyses also demonstrated that patients in the mct group had significantly greater reductions in the panss positive syndrome score ( @partial = @ ; p = @ ) and the psychotic symptom rating scales delusion score ( @partial = @ ; p = @ ) . significant group differences at the @-year follow-up were also found on measures of self-esteem and quality of life , which did not distinguish groups at earlier assessment points . attention was improved in the neuropsychological training group relative to the mct group . the completion rate was @ % after @ years . metacognitive training demonstrated sustained effects in the reduction of delusions , which were over and above the effects of antipsychotic medication . moreover , there were some unanticipated ( `` sleeper '' ) effects as both self-esteem and quality of life were improved after @ years . effects on self-esteem and well-being were found even in the absence of an improvement on the jumping to conclusions bias . isrctn.org identifier : isrctn@ .
25,103,718
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "metabolic syndrome is a complex disorder represented by a set of cardiovascular risk factors .", "a healthy lifestyle is strongly related to improve quality of life and interfere positively in the control of risk factors presented in this condition .", "to evaluate the effect of a program of lifestyle modification on the framingham general cardiovascular risk profile in subjects diagnosed with metabolic syndrome .", "a sub-analysis study of a randomized clinical trial controlled blind that lasted three months .", "participants were randomized into four groups : dietary intervention + placebo ( dip ) , dietary intervention + supplementation of omega @ ( fish oil @ g/day ) ( dis@ ) , dietary intervention + placebo + physical activity ( dipe ) and dietary intervention + physical activity + supplementation of omega @ ( dis@pe ) .", "the general cardiovascular risk profile of each individual was calculated before and after the intervention .", "the study included @ subjects .", "evaluating the score between the pre and post intervention yielded a significant value ( p < @ ) .", "we obtained a reduction for intermediate risk in @ % of subjects .", "after intervention , there was a significant reduction ( p < @ ) on cardiovascular age , this being more significant in groups dip ( @ % ) and dipe ( @ % ) .", "proposed interventions produced beneficial effects for reducing cardiovascular risk score .", "this study emphasizes the importance of lifestyle modification in the prevention and treatment of cardiovascular diseases ." ]
metabolic syndrome is a complex disorder represented by a set of cardiovascular risk factors . a healthy lifestyle is strongly related to improve quality of life and interfere positively in the control of risk factors presented in this condition . to evaluate the effect of a program of lifestyle modification on the framingham general cardiovascular risk profile in subjects diagnosed with metabolic syndrome . a sub-analysis study of a randomized clinical trial controlled blind that lasted three months . participants were randomized into four groups : dietary intervention + placebo ( dip ) , dietary intervention + supplementation of omega @ ( fish oil @ g/day ) ( dis@ ) , dietary intervention + placebo + physical activity ( dipe ) and dietary intervention + physical activity + supplementation of omega @ ( dis@pe ) . the general cardiovascular risk profile of each individual was calculated before and after the intervention . the study included @ subjects . evaluating the score between the pre and post intervention yielded a significant value ( p < @ ) . we obtained a reduction for intermediate risk in @ % of subjects . after intervention , there was a significant reduction ( p < @ ) on cardiovascular age , this being more significant in groups dip ( @ % ) and dipe ( @ % ) . proposed interventions produced beneficial effects for reducing cardiovascular risk score . this study emphasizes the importance of lifestyle modification in the prevention and treatment of cardiovascular diseases .
24,652,053
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to explore the efficacy and safety of recombinant tissue plasminogen activator ( rt-pa ) in thrombolytic therapy of vena caval thromboembolism .", "ninety patients diagnosed of vena caval thromboembolism by ultrasound or angiography of inferior vena cava were randomly assigned into @ groups .", "rt-pa and parental anticoagulant were given to the patients in the treatment group while those in the control group received only parental anticoagulation .", "d-dimer , fibrinogen and fibrinogen degradation product were analyzed after @-week treatment .", "all subjects were closely monitored for the occurrence of severe complications .", "the changes from baseline in the above laboratory parameters in the treatment group were significantly greater than those of the control group ( p < @ ) .", "no severe complications occurred in either group .", "rt-pa is both safe and effective for the thrombolytic therapy of vena caval thromboembolism ." ]
to explore the efficacy and safety of recombinant tissue plasminogen activator ( rt-pa ) in thrombolytic therapy of vena caval thromboembolism . ninety patients diagnosed of vena caval thromboembolism by ultrasound or angiography of inferior vena cava were randomly assigned into @ groups . rt-pa and parental anticoagulant were given to the patients in the treatment group while those in the control group received only parental anticoagulation . d-dimer , fibrinogen and fibrinogen degradation product were analyzed after @-week treatment . all subjects were closely monitored for the occurrence of severe complications . the changes from baseline in the above laboratory parameters in the treatment group were significantly greater than those of the control group ( p < @ ) . no severe complications occurred in either group . rt-pa is both safe and effective for the thrombolytic therapy of vena caval thromboembolism .
24,548,399
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "intimate partner violence ( ipv ) is a common , costly societal problem .", "interventions designed to reduce ipv recidivism have had limited success but primary prevention efforts are likely to be more effective in reducing the occurrence of ipv .", "the purpose of this study was to examine the impact of a computer-based preventive intervention ( eprep ) on ipv in a sample of married , community couples .", "we employed a randomized clinical trial design comparing eprep to an active placebo control group .", "using a community sample of @ married couples ( @ % black , @ % asian , @ % white , @ % latino , @ % mixed/biracial ) who had been married , on average , @ years , we examined the impact eprep on ipv as measured by self and partner reports of the revised conflict tactics scale .", "we assessed couples at baseline , six-weeks post-baseline , and one-year post-baseline .", "we used the actor partner interdependence model with treatment effects to analyze the obtained dyadic data .", "we found that eprep reduced physical and psychological aggression among married couples ( on average across informants , a @ % reduction in expected counts of physical aggression , and a @ standard deviation reduction in psychological aggression ) and that these gains were maintained at a @-year follow-up assessment .", "interventions that can be delivered widely and at a low-cost will increase the likelihood of reaching those who will benefit most from receiving them .", "implications for implementing flexible interventions and changing our approach to treatment delivery are discussed ." ]
intimate partner violence ( ipv ) is a common , costly societal problem . interventions designed to reduce ipv recidivism have had limited success but primary prevention efforts are likely to be more effective in reducing the occurrence of ipv . the purpose of this study was to examine the impact of a computer-based preventive intervention ( eprep ) on ipv in a sample of married , community couples . we employed a randomized clinical trial design comparing eprep to an active placebo control group . using a community sample of @ married couples ( @ % black , @ % asian , @ % white , @ % latino , @ % mixed/biracial ) who had been married , on average , @ years , we examined the impact eprep on ipv as measured by self and partner reports of the revised conflict tactics scale . we assessed couples at baseline , six-weeks post-baseline , and one-year post-baseline . we used the actor partner interdependence model with treatment effects to analyze the obtained dyadic data . we found that eprep reduced physical and psychological aggression among married couples ( on average across informants , a @ % reduction in expected counts of physical aggression , and a @ standard deviation reduction in psychological aggression ) and that these gains were maintained at a @-year follow-up assessment . interventions that can be delivered widely and at a low-cost will increase the likelihood of reaching those who will benefit most from receiving them . implications for implementing flexible interventions and changing our approach to treatment delivery are discussed .
24,463,577
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "dexmedetomidine ( d ) can prolong the duration of local anesthetics , but the effect of caudal dexmedetomidine on the potency of levobupivacaine ( l ) for caudal block has not been investigated .", "this study was designed to determine the effect of caudal dexmedetomidine on levobupivacaine for caudal block in pediatric patients .", "eighty-nine children scheduled for elective inguinal hernia repair or hydrocele were randomly assigned to one of the three groups : group l ( caudal levobupivacaine ) , group ld@ ( levobupivacaine plus @gkg ( -@ ) dexmedetomidine ) , or group ld@ ( levobupivacaine plus @gkg ( -@ ) dexmedetomidine ) .", "the primary endpoint was the minimum local anesthetic concentration ( mlac ) , which was determined using the dixon up-and-down method .", "the secondary endpoints were the duration of analgesia and sedation .", "the mlac values ( sd ) of caudal levobupivacaine were @ ( @ ) % , @ ( @ ) % , and @ ( @ ) % in groups l , ld@ , and ld@ , respectively .", "the values of ec@ and ec@ ( @ % ci ) of caudal levobupivacaine from logistic regression analysis were @ ( @-@ @ ) % and @ ( @-@ @ ) % , @ ( @-@ @ ) % and @ ( @-@ @ ) % , and @ ( @-@ @ ) % and @ ( @-@ @ ) % in groups l , ld@ , and ld@ , respectively .", "the mean durations of analgesia in the postoperative period were @ , @ , and @min in groups l , ld@ , and ld@ , respectively ( l vs ld@ or ld@ , p < @ ) .", "the mean durations of sedation in both groups ld@ and ld@ also were significantly prolonged , compared with group l ( p < @ ) .", "caudal dexmedetomidine reduces the mlac values of levobupivacaine and improves postoperative analgesia in children without any neurological side effects ." ]
dexmedetomidine ( d ) can prolong the duration of local anesthetics , but the effect of caudal dexmedetomidine on the potency of levobupivacaine ( l ) for caudal block has not been investigated . this study was designed to determine the effect of caudal dexmedetomidine on levobupivacaine for caudal block in pediatric patients . eighty-nine children scheduled for elective inguinal hernia repair or hydrocele were randomly assigned to one of the three groups : group l ( caudal levobupivacaine ) , group ld@ ( levobupivacaine plus @gkg ( -@ ) dexmedetomidine ) , or group ld@ ( levobupivacaine plus @gkg ( -@ ) dexmedetomidine ) . the primary endpoint was the minimum local anesthetic concentration ( mlac ) , which was determined using the dixon up-and-down method . the secondary endpoints were the duration of analgesia and sedation . the mlac values ( sd ) of caudal levobupivacaine were @ ( @ ) % , @ ( @ ) % , and @ ( @ ) % in groups l , ld@ , and ld@ , respectively . the values of ec@ and ec@ ( @ % ci ) of caudal levobupivacaine from logistic regression analysis were @ ( @-@ @ ) % and @ ( @-@ @ ) % , @ ( @-@ @ ) % and @ ( @-@ @ ) % , and @ ( @-@ @ ) % and @ ( @-@ @ ) % in groups l , ld@ , and ld@ , respectively . the mean durations of analgesia in the postoperative period were @ , @ , and @min in groups l , ld@ , and ld@ , respectively ( l vs ld@ or ld@ , p < @ ) . the mean durations of sedation in both groups ld@ and ld@ also were significantly prolonged , compared with group l ( p < @ ) . caudal dexmedetomidine reduces the mlac values of levobupivacaine and improves postoperative analgesia in children without any neurological side effects .
24,383,602
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "commercial diving often occurs in low visibility , where divers are reliant on their tactile senses .", "this study examined the effect of nitrogen narcosis on tactile memory for shapes as well as the influence of psychological and biographical factors on this relationship .", "this crossover study tested @ commercial divers in a dry hyperbaric chamber at @ and @ kpa ( @ and @ atmospheres absolute/atm abs ) .", "divers memorized shapes while blindfolded , using their tactile senses only .", "delayed recall was measured at the surface after each dive .", "psychological and biographical data were also collected .", "a significant effect of hyperbaric pressure on tactile memory was demonstrated , and a further effect of sequence of testing found .", "thus , divers ' delayed shape recall deteriorated by @ % after learning material at depth , compared to learning on the surface .", "there were also significant but small effects of psychological and biographical markers on tactile memory performance , with lower trait anxiety associated with better recall , and lower education associated with poorer recall .", "the findings emphasize the importance of utilizing other forms of recording of events or objects at depth , particularly in conditions of low visibility during deeper diving , to aid memory encoding and subsequent recall at the surface ." ]
commercial diving often occurs in low visibility , where divers are reliant on their tactile senses . this study examined the effect of nitrogen narcosis on tactile memory for shapes as well as the influence of psychological and biographical factors on this relationship . this crossover study tested @ commercial divers in a dry hyperbaric chamber at @ and @ kpa ( @ and @ atmospheres absolute/atm abs ) . divers memorized shapes while blindfolded , using their tactile senses only . delayed recall was measured at the surface after each dive . psychological and biographical data were also collected . a significant effect of hyperbaric pressure on tactile memory was demonstrated , and a further effect of sequence of testing found . thus , divers ' delayed shape recall deteriorated by @ % after learning material at depth , compared to learning on the surface . there were also significant but small effects of psychological and biographical markers on tactile memory performance , with lower trait anxiety associated with better recall , and lower education associated with poorer recall . the findings emphasize the importance of utilizing other forms of recording of events or objects at depth , particularly in conditions of low visibility during deeper diving , to aid memory encoding and subsequent recall at the surface .
25,558,545
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "children born prematurely who develop retinopathy of prematurity ( rop ) often develop myopia , and those who require laser treatment may develop very high myopia , which has considerable clinical consequences .", "to report refractive outcomes in preterm infants who developed rop in zone i or zone ii posterior as stage @ + rop or aggressive posterior rop ( aprop ) .", "all infants received intravitreal bevacizumab or laser therapy in a prospective , stratified , randomized , controlled , masked , multicenter clinical trial , bevacizumab eliminates the angiogenic threat for rop ( beat-rop ) .", "children who received intravitreal bevacizumab or laser in the beat-rop clinical trial , with treatment randomized by infant , underwent cycloplegic retinoscopic refraction at a mean age of @ years .", "fifteen centers with both pediatric and vitreoretinal ophthalmologists participating in level @ neonatal intensive care units in academic centers with institutional review board approval were included in the trial .", "of the originally enrolled @ infants ( @ eyes ) in the beat-rop clinical trial , @ infants ( @ eyes ) died ( @ received intravitreal bevacizumab ; @ received laser ) and @ eyes had intraocular surgery ( @ infants bilaterally ) .", "thus , @ eyes ( @ infants bilaterally ) were excluded , leaving @ infants ( @ eyes , including @ eyes that received a successful second treatment for recurrence ) .", "follow-up of the beat-rop cohort .", "spherical equivalent refractive outcomes and their distribution by rop zone and treatment .", "refractions were available for @ of @ eligible infants ( @ % ) and @ of @ eyes ( @ % ) .", "mean ( sd ) spherical equivalent refractions were as follows : zone i , -@ ( @ ) diopters ( d ) in @ eyes that received intravitreal bevacizumab and -@ ( @ ) d in @ eyes that received laser treatment ( p < @ ) ; and zone ii posterior , -@ ( @ ) d in @ eyes that received intravitreal bevacizumab and -@ ( @ ) d in @ eyes that received laser treatment ( p < @ ) .", "very high myopia ( -@ d ) occurred in zone i in @ of @ ( @ % ) eyes that received intravitreal bevacizumab and in @ of @ ( @ % ) eyes that received laser treatment ( p < @ ) .", "very high myopia occurred in zone ii posterior in @ of @ ( @ % ) eyes that received intravitreal bevacizumab and in @ of @ ( @ % ) eyes that received laser treatment ( p < @ ) .", "more very high myopia was found in eyes that received laser treatment than in eyes that received intravitreal bevacizumab .", "this difference is possibly related to anterior segment development that is present with intravitreal bevacizumab but minimal or absent following laser treatment .", "clinicaltrials.gov identifier : nct@ ." ]
children born prematurely who develop retinopathy of prematurity ( rop ) often develop myopia , and those who require laser treatment may develop very high myopia , which has considerable clinical consequences . to report refractive outcomes in preterm infants who developed rop in zone i or zone ii posterior as stage @ + rop or aggressive posterior rop ( aprop ) . all infants received intravitreal bevacizumab or laser therapy in a prospective , stratified , randomized , controlled , masked , multicenter clinical trial , bevacizumab eliminates the angiogenic threat for rop ( beat-rop ) . children who received intravitreal bevacizumab or laser in the beat-rop clinical trial , with treatment randomized by infant , underwent cycloplegic retinoscopic refraction at a mean age of @ years . fifteen centers with both pediatric and vitreoretinal ophthalmologists participating in level @ neonatal intensive care units in academic centers with institutional review board approval were included in the trial . of the originally enrolled @ infants ( @ eyes ) in the beat-rop clinical trial , @ infants ( @ eyes ) died ( @ received intravitreal bevacizumab ; @ received laser ) and @ eyes had intraocular surgery ( @ infants bilaterally ) . thus , @ eyes ( @ infants bilaterally ) were excluded , leaving @ infants ( @ eyes , including @ eyes that received a successful second treatment for recurrence ) . follow-up of the beat-rop cohort . spherical equivalent refractive outcomes and their distribution by rop zone and treatment . refractions were available for @ of @ eligible infants ( @ % ) and @ of @ eyes ( @ % ) . mean ( sd ) spherical equivalent refractions were as follows : zone i , -@ ( @ ) diopters ( d ) in @ eyes that received intravitreal bevacizumab and -@ ( @ ) d in @ eyes that received laser treatment ( p < @ ) ; and zone ii posterior , -@ ( @ ) d in @ eyes that received intravitreal bevacizumab and -@ ( @ ) d in @ eyes that received laser treatment ( p < @ ) . very high myopia ( -@ d ) occurred in zone i in @ of @ ( @ % ) eyes that received intravitreal bevacizumab and in @ of @ ( @ % ) eyes that received laser treatment ( p < @ ) . very high myopia occurred in zone ii posterior in @ of @ ( @ % ) eyes that received intravitreal bevacizumab and in @ of @ ( @ % ) eyes that received laser treatment ( p < @ ) . more very high myopia was found in eyes that received laser treatment than in eyes that received intravitreal bevacizumab . this difference is possibly related to anterior segment development that is present with intravitreal bevacizumab but minimal or absent following laser treatment . clinicaltrials.gov identifier : nct@ .
25,103,848
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "efficacy and safety of sugammadex in reversing neuromuscular block induced by rocuronium or vecuronium were investgated in japanese patients .", "we studied @ japanese patients undergoing surgery requiring general anesthesia .", "patients were allocated randomly to receive intubation dose of rocuronium or vecuronium .", "during surgery , patients received additional dose of rocuronium or vecuronium for maintenance of deep block .", "at @-@ ptc , @-@ @ mg .", "kg-@ of sugammadex was administered .", "the neuromuscular block was monitored with acceleromyography using tof stimuli .", "sevoflurane was administered to all treatment groups after intubation .", "for the rocuronium-induced neuromuscular block , the mean recovery time of the t@/t@ ratio to @ decreased from @ min in the sugammadex @ mg kg-@ group to @ min in the sugammadex @ mg kg-@ group .", "for the vecuronium-induced neuromuscular block it decreased from @ min in the sugammadex @ mg .", "kg-@ group to @ min in the sugammadex @ mg .", "kg-@ group .", "no clinical evidence of recurarization or residual curarization was observed .", "the efficacy and safety of sugammadex were confirmed in japanese surgical patients for reversal from deep block ." ]
efficacy and safety of sugammadex in reversing neuromuscular block induced by rocuronium or vecuronium were investgated in japanese patients . we studied @ japanese patients undergoing surgery requiring general anesthesia . patients were allocated randomly to receive intubation dose of rocuronium or vecuronium . during surgery , patients received additional dose of rocuronium or vecuronium for maintenance of deep block . at @-@ ptc , @-@ @ mg . kg-@ of sugammadex was administered . the neuromuscular block was monitored with acceleromyography using tof stimuli . sevoflurane was administered to all treatment groups after intubation . for the rocuronium-induced neuromuscular block , the mean recovery time of the t@/t@ ratio to @ decreased from @ min in the sugammadex @ mg kg-@ group to @ min in the sugammadex @ mg kg-@ group . for the vecuronium-induced neuromuscular block it decreased from @ min in the sugammadex @ mg . kg-@ group to @ min in the sugammadex @ mg . kg-@ group . no clinical evidence of recurarization or residual curarization was observed . the efficacy and safety of sugammadex were confirmed in japanese surgical patients for reversal from deep block .
25,693,333
[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "few treatments have the potential to reduce the severity of radiation-induced mucositis in head and neck cancer patients .", "some small studies have suggested that organic honey may be a useful preventive treatment .", "this investigator-initiated double-blind randomized placebo-controlled trial investigated whether honey reduced the severity of radiation-induced oral mucositis ( rom ) .", "one hundred six head and neck cancer patients from the vancouver and sudbury cancer centers in canada were randomized to swish , hold , and swallow either @ ml of irradiated organic manuka honey or a placebo gel , four times a day throughout radiation treatment , plus seven more days .", "severity of oral mucositis according to the radiation therapy oncology group ( rtog ) , world health organization ( who ) , and oral mucositis assessment scale scales , weight , and subjects ' symptom severity and quality of life were assessed weekly .", "sialometry was performed at baseline and at the last study visit .", "one hundred six patients were recruited .", "twenty-four did not attend any mucositis assessments .", "one was removed from the study because of off-study consumption of store-bought manuka honey .", "the remaining @ patients had at least one mucositis assessment and were included in the analysis .", "sixty-two percent of subjects received concurrent chemotherapy ; @ % were male .", "the groups were well-matched , and blinding was excellent .", "dropouts were mostly due to nausea and were similar in both arms , with @ % being able to tolerate the study products for more than @ week .", "the dropout rate was @ % in those who received honey and @ % in those who received placebo gel .", "the dropout rate in those who had concurrent chemotherapy was @ % and in those who only received radiation was @ % .", "there was no statistically significant difference between the honey and placebo arms in any of the outcome indicators .", "those who completed the study in both treatment arms had low rates of rtog greater than or equal to grade @ mucositis ; @ % in the honey group and @ % in the placebo group .", "despite promising earlier reports , manuka honey was not tolerated well by our patients and , even when used as directed , did not have a significant impact on the severity of rom ." ]
few treatments have the potential to reduce the severity of radiation-induced mucositis in head and neck cancer patients . some small studies have suggested that organic honey may be a useful preventive treatment . this investigator-initiated double-blind randomized placebo-controlled trial investigated whether honey reduced the severity of radiation-induced oral mucositis ( rom ) . one hundred six head and neck cancer patients from the vancouver and sudbury cancer centers in canada were randomized to swish , hold , and swallow either @ ml of irradiated organic manuka honey or a placebo gel , four times a day throughout radiation treatment , plus seven more days . severity of oral mucositis according to the radiation therapy oncology group ( rtog ) , world health organization ( who ) , and oral mucositis assessment scale scales , weight , and subjects ' symptom severity and quality of life were assessed weekly . sialometry was performed at baseline and at the last study visit . one hundred six patients were recruited . twenty-four did not attend any mucositis assessments . one was removed from the study because of off-study consumption of store-bought manuka honey . the remaining @ patients had at least one mucositis assessment and were included in the analysis . sixty-two percent of subjects received concurrent chemotherapy ; @ % were male . the groups were well-matched , and blinding was excellent . dropouts were mostly due to nausea and were similar in both arms , with @ % being able to tolerate the study products for more than @ week . the dropout rate was @ % in those who received honey and @ % in those who received placebo gel . the dropout rate in those who had concurrent chemotherapy was @ % and in those who only received radiation was @ % . there was no statistically significant difference between the honey and placebo arms in any of the outcome indicators . those who completed the study in both treatment arms had low rates of rtog greater than or equal to grade @ mucositis ; @ % in the honey group and @ % in the placebo group . despite promising earlier reports , manuka honey was not tolerated well by our patients and , even when used as directed , did not have a significant impact on the severity of rom .
24,221,577
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "indigenous australian youth ( aged @ to @ ) have up to four times the risk of suicide compared with their non-indigenous counterparts .", "barriers to help-seeking include shame , feared loss of autonomy and negative attitudes towards healthcare providers .", "the use of mobile devices and apps continues to rise amongst young people , thus presenting opportunities to utilize these aids in overcoming help-seeking barriers .", "apps have been shown to assist in several health-related areas , including weight loss and smoking cessation , although no apps have as yet been evaluated for suicide prevention .", "moreover , there is a lack of research that scientifically evaluates suicide prevention interventions within indigenous communities .", "in this study , a recently developed self-help app will be evaluated in a randomized controlled trial .", "the intervention is based on acceptance and commitment therapy and mindfulness-based cognitive behavioural therapy .", "it is aimed at participants who have suicidal thoughts but who are not actively suicidal .", "in total , @ participants will be randomly allocated to the intervention-condition ( n = @ ) or to the wait-list control condition ( n = @ ) .", "questionnaires will be completed at baseline , post-test and @ weeks follow-up .", "the primary outcome measure is a reduction in frequency and intensity of suicidal thoughts .", "secondary outcome measures are the reduction of depression , anxiety and impulsivity .", "this study is the first to evaluate the effectiveness of a self-help app for suicidal thoughts amongst young indigenous people .", "several limitations and strengths of the design are discussed .", "australian new zealand clinical trials registry ( anzctr ) : actrn@ ." ]
indigenous australian youth ( aged @ to @ ) have up to four times the risk of suicide compared with their non-indigenous counterparts . barriers to help-seeking include shame , feared loss of autonomy and negative attitudes towards healthcare providers . the use of mobile devices and apps continues to rise amongst young people , thus presenting opportunities to utilize these aids in overcoming help-seeking barriers . apps have been shown to assist in several health-related areas , including weight loss and smoking cessation , although no apps have as yet been evaluated for suicide prevention . moreover , there is a lack of research that scientifically evaluates suicide prevention interventions within indigenous communities . in this study , a recently developed self-help app will be evaluated in a randomized controlled trial . the intervention is based on acceptance and commitment therapy and mindfulness-based cognitive behavioural therapy . it is aimed at participants who have suicidal thoughts but who are not actively suicidal . in total , @ participants will be randomly allocated to the intervention-condition ( n = @ ) or to the wait-list control condition ( n = @ ) . questionnaires will be completed at baseline , post-test and @ weeks follow-up . the primary outcome measure is a reduction in frequency and intensity of suicidal thoughts . secondary outcome measures are the reduction of depression , anxiety and impulsivity . this study is the first to evaluate the effectiveness of a self-help app for suicidal thoughts amongst young indigenous people . several limitations and strengths of the design are discussed . australian new zealand clinical trials registry ( anzctr ) : actrn@ .
24,257,410
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "few investigations have addressed the safety of oxygen from concentrators for use in anesthesia in association with nitrous oxide .", "this study evaluated the percent of oxygen from a concentrator in association with nitrous oxide in a semi-closed rebreathing circuit .", "adult patients undergoing low risk surgery were randomly allocated into two groups , receiving a fresh gas flow of oxygen from concentrators ( o@ ) or of oxygen from concentrators and nitrous oxide ( o@n@o ) .", "the fraction of inspired oxygen and the percentage of oxygen from fresh gas flow were measured every @ min .", "the ratio of fio@/oxygen concentration delivered was compared at various time intervals and between the groups .", "thirty patients were studied in each group .", "there was no difference in oxygen from concentrators over time for both groups , but there was a significant improvement in the fio@ ( p < @ ) for o@ group while a significant decline ( p < @ ) for o@n@o .", "the fio@/oxygen ratio varied in both groups , reaching a plateau in the o@ group .", "pulse oximetry did not fall below @ % in either group .", "the fio@ in the mixture of o@ and nitrous oxide fell during the observation period although oxygen saturation was higher than @ % throughout the study .", "concentrators can be considered a stable source of oxygen for use during short anesthetic procedures , either pure or in association with nitrous oxide at @:@ volume ." ]
few investigations have addressed the safety of oxygen from concentrators for use in anesthesia in association with nitrous oxide . this study evaluated the percent of oxygen from a concentrator in association with nitrous oxide in a semi-closed rebreathing circuit . adult patients undergoing low risk surgery were randomly allocated into two groups , receiving a fresh gas flow of oxygen from concentrators ( o@ ) or of oxygen from concentrators and nitrous oxide ( o@n@o ) . the fraction of inspired oxygen and the percentage of oxygen from fresh gas flow were measured every @ min . the ratio of fio@/oxygen concentration delivered was compared at various time intervals and between the groups . thirty patients were studied in each group . there was no difference in oxygen from concentrators over time for both groups , but there was a significant improvement in the fio@ ( p < @ ) for o@ group while a significant decline ( p < @ ) for o@n@o . the fio@/oxygen ratio varied in both groups , reaching a plateau in the o@ group . pulse oximetry did not fall below @ % in either group . the fio@ in the mixture of o@ and nitrous oxide fell during the observation period although oxygen saturation was higher than @ % throughout the study . concentrators can be considered a stable source of oxygen for use during short anesthetic procedures , either pure or in association with nitrous oxide at @:@ volume .
24,907,874
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "conflicting blood pressure-lowering effects of catheter-based renal artery denervation have been reported in patients with resistant hypertension .", "we compared the ambulatory blood pressure-lowering efficacy and safety of radiofrequency-based renal denervation added to a standardised stepped-care antihypertensive treatment ( ssaht ) with the same ssaht alone in patients with resistant hypertension .", "the renal denervation for hypertension ( denerhtn ) trial was a prospective , open-label randomised controlled trial with blinded endpoint evaluation in patients with resistant hypertension , done in @ french tertiary care centres specialised in hypertension management .", "eligible patients aged @-@ years received indapamide @ mg , ramipril @ mg ( or irbesartan @ mg ) , and amlodipine @ mg daily for @ weeks to confirm treatment resistance by ambulatory blood pressure monitoring before randomisation .", "patients were then randomly assigned ( @:@ ) to receive either renal denervation plus an ssaht regimen ( renal denervation group ) or the same ssaht alone ( control group ) .", "the randomisation sequence was generated by computer , and stratified by centres .", "for ssaht , after randomisation , spironolactone @ mg per day , bisoprolol @ mg per day , prazosin @ mg per day , and rilmenidine @ mg per day were sequentially added from months two to five in both groups if home blood pressure was more than or equal to @/@ mm hg .", "the primary endpoint was the mean change in daytime systolic blood pressure from baseline to @ months as assessed by ambulatory blood pressure monitoring .", "the primary endpoint was analysed blindly .", "the safety outcomes were the incidence of acute adverse events of the renal denervation procedure and the change in estimated glomerular filtration rate from baseline to @ months .", "this trial is registered with clinicaltrials.gov , number nct@ .", "between may @ , @ , and oct @ , @ , @ patients were screened for eligibility , @ of those were randomly assigned to treatment ( @ patients in each group , intention-to-treat population ) and @ analysed because of patients with missing endpoints ( @ in the renal denervation group , @ in the control group , modified intention-to-treat population ) .", "the mean change in daytime ambulatory systolic blood pressure at @ months was -@ mm hg ( @ % ci -@ to -@ ) in the renal denervation group and -@ mm hg ( -@ to -@ ) in the group receiving ssaht alone , a baseline-adjusted difference of -@ mm hg ( -@ to -@ ; p = @ ) .", "the number of antihypertensive drugs and drug-adherence at @ months were similar between the two groups .", "three minor renal denervation-related adverse events were noted ( lumbar pain in two patients and mild groin haematoma in one patient ) .", "a mild and similar decrease in estimated glomerular filtration rate from baseline to @ months was observed in both groups .", "in patients with well defined resistant hypertension , renal denervation plus an ssaht decreases ambulatory blood pressure more than the same ssaht alone at @ months .", "this additional blood pressure lowering effect may contribute to a reduction in cardiovascular morbidity if maintained in the long term after renal denervation .", "french ministry of health ." ]
conflicting blood pressure-lowering effects of catheter-based renal artery denervation have been reported in patients with resistant hypertension . we compared the ambulatory blood pressure-lowering efficacy and safety of radiofrequency-based renal denervation added to a standardised stepped-care antihypertensive treatment ( ssaht ) with the same ssaht alone in patients with resistant hypertension . the renal denervation for hypertension ( denerhtn ) trial was a prospective , open-label randomised controlled trial with blinded endpoint evaluation in patients with resistant hypertension , done in @ french tertiary care centres specialised in hypertension management . eligible patients aged @-@ years received indapamide @ mg , ramipril @ mg ( or irbesartan @ mg ) , and amlodipine @ mg daily for @ weeks to confirm treatment resistance by ambulatory blood pressure monitoring before randomisation . patients were then randomly assigned ( @:@ ) to receive either renal denervation plus an ssaht regimen ( renal denervation group ) or the same ssaht alone ( control group ) . the randomisation sequence was generated by computer , and stratified by centres . for ssaht , after randomisation , spironolactone @ mg per day , bisoprolol @ mg per day , prazosin @ mg per day , and rilmenidine @ mg per day were sequentially added from months two to five in both groups if home blood pressure was more than or equal to @/@ mm hg . the primary endpoint was the mean change in daytime systolic blood pressure from baseline to @ months as assessed by ambulatory blood pressure monitoring . the primary endpoint was analysed blindly . the safety outcomes were the incidence of acute adverse events of the renal denervation procedure and the change in estimated glomerular filtration rate from baseline to @ months . this trial is registered with clinicaltrials.gov , number nct@ . between may @ , @ , and oct @ , @ , @ patients were screened for eligibility , @ of those were randomly assigned to treatment ( @ patients in each group , intention-to-treat population ) and @ analysed because of patients with missing endpoints ( @ in the renal denervation group , @ in the control group , modified intention-to-treat population ) . the mean change in daytime ambulatory systolic blood pressure at @ months was -@ mm hg ( @ % ci -@ to -@ ) in the renal denervation group and -@ mm hg ( -@ to -@ ) in the group receiving ssaht alone , a baseline-adjusted difference of -@ mm hg ( -@ to -@ ; p = @ ) . the number of antihypertensive drugs and drug-adherence at @ months were similar between the two groups . three minor renal denervation-related adverse events were noted ( lumbar pain in two patients and mild groin haematoma in one patient ) . a mild and similar decrease in estimated glomerular filtration rate from baseline to @ months was observed in both groups . in patients with well defined resistant hypertension , renal denervation plus an ssaht decreases ambulatory blood pressure more than the same ssaht alone at @ months . this additional blood pressure lowering effect may contribute to a reduction in cardiovascular morbidity if maintained in the long term after renal denervation . french ministry of health .
25,631,070
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "previously published research that examined the effects of high egg consumption in people with type @ diabetes ( t@d ) produced conflicting results leading to recommendations to limit egg intake .", "however , people with t@d may benefit from egg consumption because eggs are a nutritious and convenient way of improving protein and micronutrient contents of the diet , which have importance for satiety and weight management .", "in this randomized controlled study , we aimed to determine whether a high-egg diet ( @ eggs/d for @ d/wk ) compared with a low-egg diet ( < @ eggs/wk ) affected circulating lipid profiles , in particular high-density lipoprotein ( hdl ) cholesterol , in overweight or obese people with prediabetes or t@d .", "a total of @ participants were randomly assigned to one of the @ diets as part of a @-mo weight maintenance study .", "participants attended the clinic monthly and were instructed on the specific types of foods and quantities to be consumed .", "there was no significant difference in the change in hdl cholesterol from screening to @ mo between groups ; the mean difference ( @ % ci ) between high - and low-egg groups was +@ mmol/l ( -@ , @ mmol/l ; p = @ ) .", "no between-group differences were shown for total cholesterol , low-density lipoprotein cholesterol , triglycerides , or glycemic control .", "both groups were matched for protein intake , but the high-egg group reported less hunger and greater satiety postbreakfast .", "polyunsaturated fatty acid ( pufa ) and monounsaturated fatty acid ( mufa ) intakes significantly increased from baseline in both groups .", "high egg consumption did not have an adverse effect on the lipid profile of people with t@d in the context of increased mufa and pufa consumption .", "this study suggests that a high-egg diet can be included safely as part of the dietary management of t@d , and it may provide greater satiety .", "this trial was registered at the australia new zealand clinical trials registry ( http://www.anzctr.org.au/ ) as actrn@ ." ]
previously published research that examined the effects of high egg consumption in people with type @ diabetes ( t@d ) produced conflicting results leading to recommendations to limit egg intake . however , people with t@d may benefit from egg consumption because eggs are a nutritious and convenient way of improving protein and micronutrient contents of the diet , which have importance for satiety and weight management . in this randomized controlled study , we aimed to determine whether a high-egg diet ( @ eggs/d for @ d/wk ) compared with a low-egg diet ( < @ eggs/wk ) affected circulating lipid profiles , in particular high-density lipoprotein ( hdl ) cholesterol , in overweight or obese people with prediabetes or t@d . a total of @ participants were randomly assigned to one of the @ diets as part of a @-mo weight maintenance study . participants attended the clinic monthly and were instructed on the specific types of foods and quantities to be consumed . there was no significant difference in the change in hdl cholesterol from screening to @ mo between groups ; the mean difference ( @ % ci ) between high - and low-egg groups was +@ mmol/l ( -@ , @ mmol/l ; p = @ ) . no between-group differences were shown for total cholesterol , low-density lipoprotein cholesterol , triglycerides , or glycemic control . both groups were matched for protein intake , but the high-egg group reported less hunger and greater satiety postbreakfast . polyunsaturated fatty acid ( pufa ) and monounsaturated fatty acid ( mufa ) intakes significantly increased from baseline in both groups . high egg consumption did not have an adverse effect on the lipid profile of people with t@d in the context of increased mufa and pufa consumption . this study suggests that a high-egg diet can be included safely as part of the dietary management of t@d , and it may provide greater satiety . this trial was registered at the australia new zealand clinical trials registry ( http://www.anzctr.org.au/ ) as actrn@ .
25,833,969
[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "patients with mycobacterium avium complex pulmonary disease are frequently administered a combination of clarithromycin , ethambutol , and rifampicin .", "however , rifampicin is known to reduce the serum levels of clarithromycin .", "it remains unclear whether a reduction in clarithromycin serum levels influences the clinical outcome of the mycobacterium avium complex pulmonary disease treatment regimen .", "to compare a three-drug regimen ( clarithromycin , ethambutol , and rifampicin ) to a two-drug regimen ( clarithromycin and ethambutol ) for the treatment of mycobacterium avium lung disease .", "in a preliminary open-label study , we randomly assigned newly diagnosed , but as-yet untreated , patients with disease caused by mycobacterium avium complex without hiv infection to either the three-drug or the two-drug regimen for @ months .", "the primary endpoint was the conversion of sputum cultures to negative after @ months of treatment .", "patient data were analyzed using the intention-to-treat method .", "of @ eligible patients , @ were assigned to the three-drug regimen and @ to the two-drug regimen .", "the rate of sputum culture conversion was @ % with the three-drug regimen and @ % with the two-drug regimen ( difference , -@ % -lsb- @ % confidence interval , -@ to @ -rsb- ) .", "the incidence of adverse events leading to the discontinuation of treatment was @ and @ % for the three-drug and the two-drug regimens , respectively .", "this preliminary study suggests that treatment with clarithromycin and ethambutol is not inferior to treatment with clarithromycin , ethambutol , and rifampicin for mycobacterium avium complex lung disease .", "our findings justify a larger clinical trial to compare long-term clinical outcomes for the two treatment regimens .", "clinical trial registered with http://www.umin.ac.jp/english/ ( umin@ ) ." ]
patients with mycobacterium avium complex pulmonary disease are frequently administered a combination of clarithromycin , ethambutol , and rifampicin . however , rifampicin is known to reduce the serum levels of clarithromycin . it remains unclear whether a reduction in clarithromycin serum levels influences the clinical outcome of the mycobacterium avium complex pulmonary disease treatment regimen . to compare a three-drug regimen ( clarithromycin , ethambutol , and rifampicin ) to a two-drug regimen ( clarithromycin and ethambutol ) for the treatment of mycobacterium avium lung disease . in a preliminary open-label study , we randomly assigned newly diagnosed , but as-yet untreated , patients with disease caused by mycobacterium avium complex without hiv infection to either the three-drug or the two-drug regimen for @ months . the primary endpoint was the conversion of sputum cultures to negative after @ months of treatment . patient data were analyzed using the intention-to-treat method . of @ eligible patients , @ were assigned to the three-drug regimen and @ to the two-drug regimen . the rate of sputum culture conversion was @ % with the three-drug regimen and @ % with the two-drug regimen ( difference , -@ % -lsb- @ % confidence interval , -@ to @ -rsb- ) . the incidence of adverse events leading to the discontinuation of treatment was @ and @ % for the three-drug and the two-drug regimens , respectively . this preliminary study suggests that treatment with clarithromycin and ethambutol is not inferior to treatment with clarithromycin , ethambutol , and rifampicin for mycobacterium avium complex lung disease . our findings justify a larger clinical trial to compare long-term clinical outcomes for the two treatment regimens . clinical trial registered with http://www.umin.ac.jp/english/ ( umin@ ) .
24,298,907
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "insomnia patients complain that mental events keep them awake .", "this study investigates how cognitive behavioural therapy ( cbt ) affects such events and considers how attributional , cognitive and psychopathological symptoms may mediate sleep improvement .", "a pragmatic , parallel-group randomized controlled trial of @ adults ( @ f : ( mean @ years ( @-@ years ) ) meeting diagnostic and statistical manual of mental disorders , @th edition ( dsm-@ ) criteria for insomnia disorder , assigned to cbt ( n = @ ; @ f ) , imagery relief therapy ( irt placebo ; n = @ ; @ f ) , or treatment as usual ( tau ; n = @ ; @ f ) , was conducted .", "cbt/irt comprised six online sessions delivered by an animated therapist , with automated web/e-mail support .", "cbt users had access to a moderated community .", "tau comprised ` usual care ' .", "participants completed the sleep disturbance questionnaire ( sdq ) , glasgow content of thoughts inventory ( gcti ) , depression anxiety and stress scales ( dass ) and sleep condition indicator ( sci ) at baseline , post treatment and @-week follow-up .", "the sample was characterised by mental arousal , notably ` trying too hard ' to sleep ( sdq ) , and by ` sleep and sleeplessness ' and ` rehearsal and planning ' thoughts ( gcti ) .", "treatment effects were observed for all sdq domains ( e.g. , cbt vs. irt : d = @ for ` trying too hard ' ) .", "cbt was also superior to irt on the gcti ( e.g. , ` rehearsal and planning ' , d = @ ; ` sleep and sleeplessness ' , d = @ ) .", "cbt vs. tau comparisons yielded larger effects , whereas placebo effects ( irt vs. tau ) were small to moderate .", "hierarchical regression demonstrated partial mediation of sci improvement by attributional and cognitive factors ( r@ = @-@ % ) following cbt .", "improvement in sleep efficiency appears to be independent of such factors .", "online cbt modifies sleep-related attributions , night-time thought content and psychopathology .", "this process partly mediates improvement in dsm-@-defined insomnia ." ]
insomnia patients complain that mental events keep them awake . this study investigates how cognitive behavioural therapy ( cbt ) affects such events and considers how attributional , cognitive and psychopathological symptoms may mediate sleep improvement . a pragmatic , parallel-group randomized controlled trial of @ adults ( @ f : ( mean @ years ( @-@ years ) ) meeting diagnostic and statistical manual of mental disorders , @th edition ( dsm-@ ) criteria for insomnia disorder , assigned to cbt ( n = @ ; @ f ) , imagery relief therapy ( irt placebo ; n = @ ; @ f ) , or treatment as usual ( tau ; n = @ ; @ f ) , was conducted . cbt/irt comprised six online sessions delivered by an animated therapist , with automated web/e-mail support . cbt users had access to a moderated community . tau comprised ` usual care ' . participants completed the sleep disturbance questionnaire ( sdq ) , glasgow content of thoughts inventory ( gcti ) , depression anxiety and stress scales ( dass ) and sleep condition indicator ( sci ) at baseline , post treatment and @-week follow-up . the sample was characterised by mental arousal , notably ` trying too hard ' to sleep ( sdq ) , and by ` sleep and sleeplessness ' and ` rehearsal and planning ' thoughts ( gcti ) . treatment effects were observed for all sdq domains ( e.g. , cbt vs. irt : d = @ for ` trying too hard ' ) . cbt was also superior to irt on the gcti ( e.g. , ` rehearsal and planning ' , d = @ ; ` sleep and sleeplessness ' , d = @ ) . cbt vs. tau comparisons yielded larger effects , whereas placebo effects ( irt vs. tau ) were small to moderate . hierarchical regression demonstrated partial mediation of sci improvement by attributional and cognitive factors ( r@ = @-@ % ) following cbt . improvement in sleep efficiency appears to be independent of such factors . online cbt modifies sleep-related attributions , night-time thought content and psychopathology . this process partly mediates improvement in dsm-@-defined insomnia .
24,791,643
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "inadequacy in mental health care in low and middle income countries has been an important contributor to the rising global burden of disease .", "the treatment gap is salient in resource-poor settings , especially when providing care for conflict-affected forced migrant populations .", "primary care is often the only available service option for the majority of forced migrants , and integration of mental health into primary care is a difficult task .", "the proposed pilot study aims to explore the feasibility of integrating mental health care into primary care by providing training to primary care practitioners serving displaced populations , in order to improve identification , treatment , and referral of patients with common mental disorders via the world health organization mental health gap action programme ( mhgap ) .", "this pilot randomized controlled trial will recruit @ primary care practitioners ( pcp ) serving in the puttalam and mannar districts of sri lanka ( with displaced and returning conflict-affected populations ) .", "the intervention arm will receive a structured training program based on the mhgap intervention guide .", "primary outcomes will be rates of correct identification , adequate management based on set criteria , and correct referrals of common mental disorders .", "a qualitative study exploring the attitudes , views , and perspectives of pcp on integrating mental health and primary care will be nested within the pilot study .", "an economic evaluation will be carried out by gathering service utilization information .", "in post-conflict sri lanka , an important need exists to provide adequate mental health care to conflict-affected internally displaced persons who are returning to their areas of origin after prolonged displacement .", "the proposed study will act as a local demonstration project , exploring the feasibility of formulating a larger-scale intervention study in the future , and is envisaged to provide information on engaging pcp , and data on training and evaluation including economic costs , patient recruitment , and acceptance and follow-up rates .", "the study should provide important information on the who mhgap intervention guide to add to the growing evidence base of its implementation .", "slctr/@/@ ." ]
inadequacy in mental health care in low and middle income countries has been an important contributor to the rising global burden of disease . the treatment gap is salient in resource-poor settings , especially when providing care for conflict-affected forced migrant populations . primary care is often the only available service option for the majority of forced migrants , and integration of mental health into primary care is a difficult task . the proposed pilot study aims to explore the feasibility of integrating mental health care into primary care by providing training to primary care practitioners serving displaced populations , in order to improve identification , treatment , and referral of patients with common mental disorders via the world health organization mental health gap action programme ( mhgap ) . this pilot randomized controlled trial will recruit @ primary care practitioners ( pcp ) serving in the puttalam and mannar districts of sri lanka ( with displaced and returning conflict-affected populations ) . the intervention arm will receive a structured training program based on the mhgap intervention guide . primary outcomes will be rates of correct identification , adequate management based on set criteria , and correct referrals of common mental disorders . a qualitative study exploring the attitudes , views , and perspectives of pcp on integrating mental health and primary care will be nested within the pilot study . an economic evaluation will be carried out by gathering service utilization information . in post-conflict sri lanka , an important need exists to provide adequate mental health care to conflict-affected internally displaced persons who are returning to their areas of origin after prolonged displacement . the proposed study will act as a local demonstration project , exploring the feasibility of formulating a larger-scale intervention study in the future , and is envisaged to provide information on engaging pcp , and data on training and evaluation including economic costs , patient recruitment , and acceptance and follow-up rates . the study should provide important information on the who mhgap intervention guide to add to the growing evidence base of its implementation . slctr/@/@ .
24,321,171
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "anti-inflammatory glucocorticoid ( gc ) therapy often induces hyperglycemia due to insulin resistance and islet-cell dysfunction .", "incretin-based therapies may preserve glucose tolerance and pancreatic islet-cell function .", "in this study , we hypothesized that concomitant administration of the dipeptidyl peptidase-@ inhibitor sitagliptin and prednisolone in men at high risk to develop type @ diabetes could protect against the gc-induced diabetogenic effects .", "men with the metabolic syndrome but without diabetes received prednisolone @ mg once daily plus sitagliptin @ mg once daily ( n = @ ) , prednisolone ( n = @ ) or sitagliptin alone ( n = @ ) or placebo ( n = @ ) for @ days in a double-blind @ @ randomized-controlled study .", "glucose , insulin , c-peptide , and glucagon were measured in the fasted state and following a standardized mixed-meal test .", "- cell function parameters were assessed both from a hyperglycemic-arginine clamp procedure and from the meal test .", "insulin sensitivity ( m-value ) was measured by euglycemic clamp .", "prednisolone increased postprandial area under the curve ( auc ) - glucose by @ % ( p < @ vs placebo ) and postprandial auc-glucagon by @ % ( p < @ ) .", "prednisolone reduced @st and @nd phase glucose-stimulated - and combined hyperglycemia-arginine-stimulated c-peptide secretion ( all p @ ) .", "when sitagliptin was added , both clamp-measured - cell function ( p = ns for @st and @nd phase vs placebo ) and postprandial hyperglucagonemia ( p = ns vs placebo ) remained unaffected .", "however , administration of sitagliptin could not prevent prednisolone-induced increment in postprandial glucose concentrations ( p < @ vs placebo ) .", "m-value was not altered by any treatment .", "fourteen-day treatment with high-dose prednisolone impaired postprandial glucose metabolism in subjects with the metabolic syndrome .", "concomitant treatment with sitagliptin improved various aspects of pancreatic islet-cell function , but did not prevent deterioration of glucose tolerance by gc treatment ." ]
anti-inflammatory glucocorticoid ( gc ) therapy often induces hyperglycemia due to insulin resistance and islet-cell dysfunction . incretin-based therapies may preserve glucose tolerance and pancreatic islet-cell function . in this study , we hypothesized that concomitant administration of the dipeptidyl peptidase-@ inhibitor sitagliptin and prednisolone in men at high risk to develop type @ diabetes could protect against the gc-induced diabetogenic effects . men with the metabolic syndrome but without diabetes received prednisolone @ mg once daily plus sitagliptin @ mg once daily ( n = @ ) , prednisolone ( n = @ ) or sitagliptin alone ( n = @ ) or placebo ( n = @ ) for @ days in a double-blind @ @ randomized-controlled study . glucose , insulin , c-peptide , and glucagon were measured in the fasted state and following a standardized mixed-meal test . - cell function parameters were assessed both from a hyperglycemic-arginine clamp procedure and from the meal test . insulin sensitivity ( m-value ) was measured by euglycemic clamp . prednisolone increased postprandial area under the curve ( auc ) - glucose by @ % ( p < @ vs placebo ) and postprandial auc-glucagon by @ % ( p < @ ) . prednisolone reduced @st and @nd phase glucose-stimulated - and combined hyperglycemia-arginine-stimulated c-peptide secretion ( all p @ ) . when sitagliptin was added , both clamp-measured - cell function ( p = ns for @st and @nd phase vs placebo ) and postprandial hyperglucagonemia ( p = ns vs placebo ) remained unaffected . however , administration of sitagliptin could not prevent prednisolone-induced increment in postprandial glucose concentrations ( p < @ vs placebo ) . m-value was not altered by any treatment . fourteen-day treatment with high-dose prednisolone impaired postprandial glucose metabolism in subjects with the metabolic syndrome . concomitant treatment with sitagliptin improved various aspects of pancreatic islet-cell function , but did not prevent deterioration of glucose tolerance by gc treatment .
24,297,090
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "fluralaner is a novel systemic insecticide and acaricide .", "the purpose of these studies was to investigate the pharmacokinetic properties of fluralaner in beagle dogs following single oral or intravenous ( i.v. ) administration .", "following the oral administration of @ , @ or @ mg fluralaner/kg body weight ( bw ) , formulated as chewable tablets or i.v. administration of @ mg fluralaner/kg bw , formulated as i.v. solution to @ beagles , plasma samples were collected until @ days after treatment .", "plasma concentrations of fluralaner were measured using hplc-ms/ms .", "pharmacokinetic parameters were calculated by non-compartmental methods .", "after oral administration , maximum plasma concentrations ( c ( max ) ) were reached within @ day on average .", "fluralaner was quantifiable in plasma for up to @ days after single oral and i.v. treatment .", "the apparent half-life of fluralaner was @-@ days and the mean residence time was @-@ days .", "the apparent volume of distribution of fluralaner was @ l/kg , and clearance was @ l/kg/day .", "fluralaner is readily absorbed after single-dose oral administration , and has a long elimination half-life , long mean residence time , relatively high apparent volume of distribution , and low clearance .", "these pharmacokinetic characteristics help to explain the prolonged activity of fluralaner against fleas and ticks on dogs after a single oral dose ." ]
fluralaner is a novel systemic insecticide and acaricide . the purpose of these studies was to investigate the pharmacokinetic properties of fluralaner in beagle dogs following single oral or intravenous ( i.v. ) administration . following the oral administration of @ , @ or @ mg fluralaner/kg body weight ( bw ) , formulated as chewable tablets or i.v. administration of @ mg fluralaner/kg bw , formulated as i.v. solution to @ beagles , plasma samples were collected until @ days after treatment . plasma concentrations of fluralaner were measured using hplc-ms/ms . pharmacokinetic parameters were calculated by non-compartmental methods . after oral administration , maximum plasma concentrations ( c ( max ) ) were reached within @ day on average . fluralaner was quantifiable in plasma for up to @ days after single oral and i.v. treatment . the apparent half-life of fluralaner was @-@ days and the mean residence time was @-@ days . the apparent volume of distribution of fluralaner was @ l/kg , and clearance was @ l/kg/day . fluralaner is readily absorbed after single-dose oral administration , and has a long elimination half-life , long mean residence time , relatively high apparent volume of distribution , and low clearance . these pharmacokinetic characteristics help to explain the prolonged activity of fluralaner against fleas and ticks on dogs after a single oral dose .
24,606,874
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to evaluate blood pressure ( bp ) control utilizing the international society on hypertension in blacks ( ishib ) cardiovascular risk reduction toolkit in an african american community with uncontrolled hypertension .", "this is a randomized controlled pilot study conducted in two baltimore community-based physicians ' offices assigned adults ( @-@ years ) with uncontrolled hypertension ( systolic blood pressure -lsb- sbp -rsb- @ mm hg ; diastolic blood pressure -lsb- dbp -rsb- @ mm hg ) .", "the study compares usual care to a community-based intervention .", "in the usual care group , the patients ' bp was managed by the treating physician based on their normal office patient care protocol .", "in the intervention group , usual care was provided but , a community health worker also gave comprehensive education and assessment to the patients based on the ishib impact cardiovascular toolkit during study initiation and follow-up visits .", "the main outcome of study was change in bp from baseline to six months .", "a secondary outcome was the proportion of patients achieving bp < @ / < @ mm hg at six months .", "fifty-four african american patients were enrolled ; @ completed six months of follow-up ( usual care , n = @ ; intervention , n = @ ) .", "at six months the mean ( @ % ci ) change from baseline in sbp was significantly greater in the intervention group vs the usual care group : -@ ( -@ to -@ ) mm hg vs -@ ( -@ to @ ) mm hg ( p < @ ) .", "mean ( @ % ci ) change in dbp from baseline to six months was significantly greater for the intervention group vs the usual care group : -@ ( -@ to -@ ) mm hg vs -@ ( -@ to -@ ) mm hg ( p = @ ) .", "median change in bp was significantly greater for sbp in the intervention group compared with the usual care group ( p = @ ) , but not for dbp ( p = @ ) .", "the proportion of patients achieving bp < @ / < @ at six months was @ % ( @/@ ) in the intervention group vs @ % ( @/@ ) in the usual care group ( p = @ ) .", "this pilot study on the ishib impact toolkit in managing uncontrolled hypertension in the african american community suggests better control of systolic bp and a tendency to better hypertension control with the community-based intervention .", "the findings support further studies in clinical settings serving african american hypertensive patients to assess effectiveness of approaches for improving bp control and related outcomes ." ]
to evaluate blood pressure ( bp ) control utilizing the international society on hypertension in blacks ( ishib ) cardiovascular risk reduction toolkit in an african american community with uncontrolled hypertension . this is a randomized controlled pilot study conducted in two baltimore community-based physicians ' offices assigned adults ( @-@ years ) with uncontrolled hypertension ( systolic blood pressure -lsb- sbp -rsb- @ mm hg ; diastolic blood pressure -lsb- dbp -rsb- @ mm hg ) . the study compares usual care to a community-based intervention . in the usual care group , the patients ' bp was managed by the treating physician based on their normal office patient care protocol . in the intervention group , usual care was provided but , a community health worker also gave comprehensive education and assessment to the patients based on the ishib impact cardiovascular toolkit during study initiation and follow-up visits . the main outcome of study was change in bp from baseline to six months . a secondary outcome was the proportion of patients achieving bp < @ / < @ mm hg at six months . fifty-four african american patients were enrolled ; @ completed six months of follow-up ( usual care , n = @ ; intervention , n = @ ) . at six months the mean ( @ % ci ) change from baseline in sbp was significantly greater in the intervention group vs the usual care group : -@ ( -@ to -@ ) mm hg vs -@ ( -@ to @ ) mm hg ( p < @ ) . mean ( @ % ci ) change in dbp from baseline to six months was significantly greater for the intervention group vs the usual care group : -@ ( -@ to -@ ) mm hg vs -@ ( -@ to -@ ) mm hg ( p = @ ) . median change in bp was significantly greater for sbp in the intervention group compared with the usual care group ( p = @ ) , but not for dbp ( p = @ ) . the proportion of patients achieving bp < @ / < @ at six months was @ % ( @/@ ) in the intervention group vs @ % ( @/@ ) in the usual care group ( p = @ ) . this pilot study on the ishib impact toolkit in managing uncontrolled hypertension in the african american community suggests better control of systolic bp and a tendency to better hypertension control with the community-based intervention . the findings support further studies in clinical settings serving african american hypertensive patients to assess effectiveness of approaches for improving bp control and related outcomes .
26,118,143
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the impact of dairy intake on cardiometabolic risk factors associated with metabolic syndrome ( mets ) needs further research .", "to investigate the impact of milk consumption on a wide array of cardiometabolic risk factors associated with mets ( blood lipids , cholesterol homeostasis , glucose homeostasis , systemic inflammation , blood pressure , endothelial function ) in postmenopausal women with abdominal obesity .", "in this randomized , crossover study , @ women with abdominal obesity consumed two @-week diets based on the national cholesterol education program ( ncep ) , one with @ servings/d of @ % fat milk per @kcal ( milk ) and one without milk or other dairy ( ncep ) .", "the macronutrient composition of both diets was comparable ( @ % carbohydrates , @ % proteins , @ % fat and @ % saturated fat ) .", "the milk diet had no significant effect on ldl-c , triglycerides , ldl size , crp and cell adhesion molecule concentrations and on indicators of insulin sensitivity .", "the milk diet reduced hdl-c , adiponectin , endothelin and fasting glucose levels as well blood pressure ( all p@ @ ) , but those changes were comparable to those seen with the ncep milk-free diet ( all between-diet p@ @ ) .", "finally , the milk diet was associated with lower vldl apolipoprotein b fractional catabolic rate ( -@ % ; p = @ ) and plasma sterol concentrations ( -@ % ; p = @ ) compared with the control ncep milk-free diet .", "these data suggest that short-term consumption of low fat milk in the context of a prudent ncep diet has no favorable nor deleterious effect on cardiometabolic risk factors associated with mets in postmenopausal women with abdominal obesity ." ]
the impact of dairy intake on cardiometabolic risk factors associated with metabolic syndrome ( mets ) needs further research . to investigate the impact of milk consumption on a wide array of cardiometabolic risk factors associated with mets ( blood lipids , cholesterol homeostasis , glucose homeostasis , systemic inflammation , blood pressure , endothelial function ) in postmenopausal women with abdominal obesity . in this randomized , crossover study , @ women with abdominal obesity consumed two @-week diets based on the national cholesterol education program ( ncep ) , one with @ servings/d of @ % fat milk per @kcal ( milk ) and one without milk or other dairy ( ncep ) . the macronutrient composition of both diets was comparable ( @ % carbohydrates , @ % proteins , @ % fat and @ % saturated fat ) . the milk diet had no significant effect on ldl-c , triglycerides , ldl size , crp and cell adhesion molecule concentrations and on indicators of insulin sensitivity . the milk diet reduced hdl-c , adiponectin , endothelin and fasting glucose levels as well blood pressure ( all p@ @ ) , but those changes were comparable to those seen with the ncep milk-free diet ( all between-diet p@ @ ) . finally , the milk diet was associated with lower vldl apolipoprotein b fractional catabolic rate ( -@ % ; p = @ ) and plasma sterol concentrations ( -@ % ; p = @ ) compared with the control ncep milk-free diet . these data suggest that short-term consumption of low fat milk in the context of a prudent ncep diet has no favorable nor deleterious effect on cardiometabolic risk factors associated with mets in postmenopausal women with abdominal obesity .
25,604,722
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "disturbances of the circadian rhythm of cortisol secretion are associated with depression , coronary calcification , and higher all-cause and cardiovascular mortality.the primary aim of this study was to test the associations between midnight salivary cortisol ( msc ) , depression and hba@c , and control for behavioural , environmental and intra individual factors with possible impact on cortisol secretion , like smoking , physical inactivity , season , medication , diabetes duration , severe hypoglycemia episodes , age and gender in patients with type @ diabetes .", "secondary aims were to present msc levels for a reference group of non-depressed type @ diabetes patients with a healthy life style ( physically active and non-smoking ) , and to explore seasonal variations .", "a cross-sectional population based study of @ patients ( @ % men and @ % women ) aged @-@ years that participated in a randomized controlled trial targeting depression in type @ diabetes .", "depression was assessed by the hospital anxiety and depression scale-depression subscale .", "msc , hba@c , serum-lipids , blood pressure , waist circumference and data from medical records and the swedish national diabetes registry were collected .", "thirty four patients ( @ % ) had msc @ nmol/l , which was associated with smoking ( aor @ ) , spring season ( aor @ ) , physical inactivity ( aor @ ) , self-reported depression ( aor @ ) , and older age ( per year ) ( aor @ ) .", "hba@c > @ mmol/mol ( > @ % ) ( aor @ ) and msc @ nmol/l ( aor @ ) were independently linked to self-reported depression .", "season was strongly associated with msc levels and no other variables studied showed seasonal variations .", "in a reference group of @ non-depressed patients with a healthy life style ( physically active , non-smoking ) the median msc level was @ nmol/l ( range @-@ @ ) .", "in this study of patients with type @ diabetes high msc was linked to smoking , physical inactivity , depression , season and older age .", "thus a high cortisol value identified three major targets for treatment in type @ diabetes ." ]
disturbances of the circadian rhythm of cortisol secretion are associated with depression , coronary calcification , and higher all-cause and cardiovascular mortality.the primary aim of this study was to test the associations between midnight salivary cortisol ( msc ) , depression and hba@c , and control for behavioural , environmental and intra individual factors with possible impact on cortisol secretion , like smoking , physical inactivity , season , medication , diabetes duration , severe hypoglycemia episodes , age and gender in patients with type @ diabetes . secondary aims were to present msc levels for a reference group of non-depressed type @ diabetes patients with a healthy life style ( physically active and non-smoking ) , and to explore seasonal variations . a cross-sectional population based study of @ patients ( @ % men and @ % women ) aged @-@ years that participated in a randomized controlled trial targeting depression in type @ diabetes . depression was assessed by the hospital anxiety and depression scale-depression subscale . msc , hba@c , serum-lipids , blood pressure , waist circumference and data from medical records and the swedish national diabetes registry were collected . thirty four patients ( @ % ) had msc @ nmol/l , which was associated with smoking ( aor @ ) , spring season ( aor @ ) , physical inactivity ( aor @ ) , self-reported depression ( aor @ ) , and older age ( per year ) ( aor @ ) . hba@c > @ mmol/mol ( > @ % ) ( aor @ ) and msc @ nmol/l ( aor @ ) were independently linked to self-reported depression . season was strongly associated with msc levels and no other variables studied showed seasonal variations . in a reference group of @ non-depressed patients with a healthy life style ( physically active , non-smoking ) the median msc level was @ nmol/l ( range @-@ @ ) . in this study of patients with type @ diabetes high msc was linked to smoking , physical inactivity , depression , season and older age . thus a high cortisol value identified three major targets for treatment in type @ diabetes .
25,224,993
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to compare efficacy difference among wrist-ankle needle , body-acupuncture and ibuprofen in the treatment of primary dysmenorrhea .", "ninety-five cases were randomly divided into a wrist-ankle needle group ( @ cases ) , a body-acupuncture group ( @ cases ) and an ibuprofen group ( @ cases ) .", "acupunc - , ture at lower @ and lower @ area was applied in the wrist-ankle needle group .", "acupuncture at guanyuan ( cv @ ) and sanyinjiao ( sp @ ) were applied in the body-acupuncture group .", "ibuprofen sustained-release capsules were given for oral administration in the ibuprofen group .", "the treatment began @ days before menses , once a day , until pain was relieved .", "one menstrual cycle was taken as a treatment course , continuously for @ courses and efficacy were observed in three groups .", "the symptom score of dysmenorrhea and visual analogue scale ( vas ) were used to assess pain severity before and after treatment .", "@the efficacy differences in three groups were statistically significant ( p < @ ) , in which the total effective rate was @ % ( @/@ ) in the wrist-ankle needle group , @ % ( @/@ ) in the body-acupuncture group and @ % ( @/@ ) in the ibuprofen group .", "@ after the treatment , symptom score of dysmenorrhea and vas were all obviously lower than that before the treatment in three groups ( all p < @ ) .", "compared with ibuprofen group ( @ + / -@ ) , after the treatment symptom score of dysmenorrhea in the wrist-ankle needle group ( @ + / -@ ) and body-acupuncture group ( @ + / -@ ) was obviously decreased ( p < @ , p < @ ) , and vas in the wrist-ankle needle group was significantly reduced ( p < @ ) .", "compared with body-acupuncture group ( @ + / -@ ) , symptom score of dysmenorrhea in the wrist-ankle needle group ( @ + / - @ ) was obviously decreased ( p < @ ) .", "the wrist-ankle needle has better effect than body acupuncture and ibuprofen on the treatment of primary dysmenorrhea , which could significantly improve dysmenorrhea symptoms ." ]
to compare efficacy difference among wrist-ankle needle , body-acupuncture and ibuprofen in the treatment of primary dysmenorrhea . ninety-five cases were randomly divided into a wrist-ankle needle group ( @ cases ) , a body-acupuncture group ( @ cases ) and an ibuprofen group ( @ cases ) . acupunc - , ture at lower @ and lower @ area was applied in the wrist-ankle needle group . acupuncture at guanyuan ( cv @ ) and sanyinjiao ( sp @ ) were applied in the body-acupuncture group . ibuprofen sustained-release capsules were given for oral administration in the ibuprofen group . the treatment began @ days before menses , once a day , until pain was relieved . one menstrual cycle was taken as a treatment course , continuously for @ courses and efficacy were observed in three groups . the symptom score of dysmenorrhea and visual analogue scale ( vas ) were used to assess pain severity before and after treatment . @the efficacy differences in three groups were statistically significant ( p < @ ) , in which the total effective rate was @ % ( @/@ ) in the wrist-ankle needle group , @ % ( @/@ ) in the body-acupuncture group and @ % ( @/@ ) in the ibuprofen group . @ after the treatment , symptom score of dysmenorrhea and vas were all obviously lower than that before the treatment in three groups ( all p < @ ) . compared with ibuprofen group ( @ + / -@ ) , after the treatment symptom score of dysmenorrhea in the wrist-ankle needle group ( @ + / -@ ) and body-acupuncture group ( @ + / -@ ) was obviously decreased ( p < @ , p < @ ) , and vas in the wrist-ankle needle group was significantly reduced ( p < @ ) . compared with body-acupuncture group ( @ + / -@ ) , symptom score of dysmenorrhea in the wrist-ankle needle group ( @ + / - @ ) was obviously decreased ( p < @ ) . the wrist-ankle needle has better effect than body acupuncture and ibuprofen on the treatment of primary dysmenorrhea , which could significantly improve dysmenorrhea symptoms .
24,494,287
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to compare the anticoagulation effect of regional citrate and heparin in patients with sustained low-efficiency hemodialysis ( sled ) .", "this study was conducted in the teaching hospital of sichuan university between november @ and january @.sixty-three patients suffering from acute kidney injury or end-stage renal diseases ( esrd ) were enrolled and further randomized to @ groups : citrate and heparin anticoagulation treatment groups in sled .", "sled was conducted by fresenius @sarrtplus dialyzer for @ hours each session , and blood flow was set at @ ml/min .", "prothrombin time ( pt ) , activated partial thromboplastin time ( aptt ) and platelet ( plt ) count were analyzed .", "sixty-three patients underwent @ sessions of sled .", "among them , @ patients ( @ % ) was discharged after treatment or converted to outpatient intermittent hemodialysis , and @ patients died of multiple organ failure during hospitalization .", "compared with that in the citrate group , both pt and aptt in heparin group was significantly higher -lsb- pt : ( @ @ ) s vs ( @ @ ) s , p < @ ; aptt : ( @ @ ) s vs ( @ @ ) s , p < @ ; respectively -rsb- at @ h during sled.however , the pt and aptt levels in heparin group decreased afterwards and were similar with those in the citrate groups at @ h during treatment .", "there is no difference on plt counts between these two groups after treatment .", "the anticoagulation effect of regional citrate and heparin was similar in patients when receiving sled.regional citrate may be an alternative anticoagulant approach for the patients at high risk of bleeding who require the treatment of sled ." ]
to compare the anticoagulation effect of regional citrate and heparin in patients with sustained low-efficiency hemodialysis ( sled ) . this study was conducted in the teaching hospital of sichuan university between november @ and january @.sixty-three patients suffering from acute kidney injury or end-stage renal diseases ( esrd ) were enrolled and further randomized to @ groups : citrate and heparin anticoagulation treatment groups in sled . sled was conducted by fresenius @sarrtplus dialyzer for @ hours each session , and blood flow was set at @ ml/min . prothrombin time ( pt ) , activated partial thromboplastin time ( aptt ) and platelet ( plt ) count were analyzed . sixty-three patients underwent @ sessions of sled . among them , @ patients ( @ % ) was discharged after treatment or converted to outpatient intermittent hemodialysis , and @ patients died of multiple organ failure during hospitalization . compared with that in the citrate group , both pt and aptt in heparin group was significantly higher -lsb- pt : ( @ @ ) s vs ( @ @ ) s , p < @ ; aptt : ( @ @ ) s vs ( @ @ ) s , p < @ ; respectively -rsb- at @ h during sled.however , the pt and aptt levels in heparin group decreased afterwards and were similar with those in the citrate groups at @ h during treatment . there is no difference on plt counts between these two groups after treatment . the anticoagulation effect of regional citrate and heparin was similar in patients when receiving sled.regional citrate may be an alternative anticoagulant approach for the patients at high risk of bleeding who require the treatment of sled .
25,623,561
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "uncontrolled intervention studies , including studies involving breast cancer survivors , have demonstrated improvements in vasomotor symptoms ( vms ) after stellate ganglion blockade ( sgb ) with a local anesthetic .", "this study presents the first randomized sham-controlled trial of sgb for the treatment of vms .", "participants included @ postmenopausal women , aged @ to @ years , with moderate to severe vms .", "the study was a randomized sham-controlled trial comparing the effects of sgb versus sham injection on the frequencies of total and moderate to severe vms , as measured by daily diaries .", "image-guided sgb was performed with @ ml of @ % bupivacaine .", "sham injection of saline was performed in subcutaneous tissues in the neck .", "vms were recorded at baseline and for @ months thereafter .", "objective vms were recorded using ambulatory sternal skin conductance monitoring during a @-hour period at baseline and on @-month follow-up .", "there were no significant group differences in overall vms frequency , but the frequency of moderate to very severe vms was reduced more in the active group compared with the sham treatment group ( event rate ratio , @ ; @ % ci , @-@ @ ; p < @ ) .", "the frequency of objective vms was also reduced to a greater degree in the sgb group than in the sham group ( event rate ratio , @ ; @ % ci , @-@ @ ; p < @ ) .", "there were no study-related serious adverse events .", "sgb may provide effective treatment of vms in women who seek nonhormonal treatments because of safety concerns and personal preference .", "the finding that sgb significantly reduces objectively measured vms provides further evidence of efficacy .", "a larger trial is warranted to confirm these findings ." ]
uncontrolled intervention studies , including studies involving breast cancer survivors , have demonstrated improvements in vasomotor symptoms ( vms ) after stellate ganglion blockade ( sgb ) with a local anesthetic . this study presents the first randomized sham-controlled trial of sgb for the treatment of vms . participants included @ postmenopausal women , aged @ to @ years , with moderate to severe vms . the study was a randomized sham-controlled trial comparing the effects of sgb versus sham injection on the frequencies of total and moderate to severe vms , as measured by daily diaries . image-guided sgb was performed with @ ml of @ % bupivacaine . sham injection of saline was performed in subcutaneous tissues in the neck . vms were recorded at baseline and for @ months thereafter . objective vms were recorded using ambulatory sternal skin conductance monitoring during a @-hour period at baseline and on @-month follow-up . there were no significant group differences in overall vms frequency , but the frequency of moderate to very severe vms was reduced more in the active group compared with the sham treatment group ( event rate ratio , @ ; @ % ci , @-@ @ ; p < @ ) . the frequency of objective vms was also reduced to a greater degree in the sgb group than in the sham group ( event rate ratio , @ ; @ % ci , @-@ @ ; p < @ ) . there were no study-related serious adverse events . sgb may provide effective treatment of vms in women who seek nonhormonal treatments because of safety concerns and personal preference . the finding that sgb significantly reduces objectively measured vms provides further evidence of efficacy . a larger trial is warranted to confirm these findings .
24,496,086
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "long-term adaptive servoventilation ( asv ) increases cardiac function more effectively than continuous positive airway pressure ( cpap ) , possibly via alleviation of sympathetic overactivation .", "the present study evaluated the effect of asv and cpap at comparable pressure on muscle sympathetic nerve activity ( msna ) in patients with heart failure ( hf ) and with or without periodic breathing ( pb ) .", "a total of @ patients with hf ( ejection fraction < @ ) were randomized to receive cpap ( n = @ ) or asv ( n = @ ) .", "respiratory profiles and msna were continuously monitored before and during cpap and asv ( @min ) at pressures of @ and @ cmh@o , respectively .", "the severity of respiratory instability was determined using the coefficient of variation of tidal volume ( cv-tv ) .", "although heart rate and blood pressure remained unchanged , only asv improved cv-tv .", "msna decreased in the asv ( p < @ ) , but not in the cpap group .", "the change in cv-tv independently predicted changes in msna ( p < @ ) .", "device type and pb significantly interacted with changes in msna ( p < @ ) and asv exerted sympathoinhibitory effects in patients with pb , whereas cpap did not .", "a sympathoinhibitory effect in patients without pb was not evident in either treatment arm .", "asv probably exerts its sympathoinhibitory effects in patients with hf and pb through pressure support ." ]
long-term adaptive servoventilation ( asv ) increases cardiac function more effectively than continuous positive airway pressure ( cpap ) , possibly via alleviation of sympathetic overactivation . the present study evaluated the effect of asv and cpap at comparable pressure on muscle sympathetic nerve activity ( msna ) in patients with heart failure ( hf ) and with or without periodic breathing ( pb ) . a total of @ patients with hf ( ejection fraction < @ ) were randomized to receive cpap ( n = @ ) or asv ( n = @ ) . respiratory profiles and msna were continuously monitored before and during cpap and asv ( @min ) at pressures of @ and @ cmh@o , respectively . the severity of respiratory instability was determined using the coefficient of variation of tidal volume ( cv-tv ) . although heart rate and blood pressure remained unchanged , only asv improved cv-tv . msna decreased in the asv ( p < @ ) , but not in the cpap group . the change in cv-tv independently predicted changes in msna ( p < @ ) . device type and pb significantly interacted with changes in msna ( p < @ ) and asv exerted sympathoinhibitory effects in patients with pb , whereas cpap did not . a sympathoinhibitory effect in patients without pb was not evident in either treatment arm . asv probably exerts its sympathoinhibitory effects in patients with hf and pb through pressure support .
24,705,391
[ "BACKGROUND", "BACKGROUND", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to determine the response , toxicities , and progression free survival of a regimen of temsirolimus with or without hormonal therapy in the treatment of advanced , or recurrent endometrial carcinoma .", "preclinical evidence suggested that blockade of the pi@k/akt/mtor pathway might overcome resistance to hormonal therapy .", "we performed a randomized phase ii trial of intravenous temsirolimus @mg weekly versus the combination of weekly temsirolimus with a regimen of megestrol acetate @ mg bid for three weeks alternating with tamoxifen @mg bid for three weeks in women with recurrent or metastatic endometrial carcinoma .", "there were @ eligible patients who received at least one dose of therapy with @ of these treated on the combination arm which was closed early because of an excess of venous thrombosis , with @ episodes of deep venous thrombosis ( dvt ) and @ pulmonary emboli .", "there were three responses observed in that arm ( @ % ) .", "a total of @ eligible patients were treated on the single agent arm with @ episodes of dvt and @ responses ( @ % ) .", "response rates were similar in patients with prior chemotherapy ( @ of @ ; @ % ) and those with no prior chemotherapy ( @ of @ ; @ % ) .", "two of four patients with clear cell carcinoma responded .", "adding the combination of megestrol acetate and tamoxifen to temsirolimus therapy did not enhance activity and the combination was associated with an excess of venous thrombosis .", "temsirolimus activity was preserved in patients with prior adjuvant chemotherapy ." ]
to determine the response , toxicities , and progression free survival of a regimen of temsirolimus with or without hormonal therapy in the treatment of advanced , or recurrent endometrial carcinoma . preclinical evidence suggested that blockade of the pi@k/akt/mtor pathway might overcome resistance to hormonal therapy . we performed a randomized phase ii trial of intravenous temsirolimus @mg weekly versus the combination of weekly temsirolimus with a regimen of megestrol acetate @ mg bid for three weeks alternating with tamoxifen @mg bid for three weeks in women with recurrent or metastatic endometrial carcinoma . there were @ eligible patients who received at least one dose of therapy with @ of these treated on the combination arm which was closed early because of an excess of venous thrombosis , with @ episodes of deep venous thrombosis ( dvt ) and @ pulmonary emboli . there were three responses observed in that arm ( @ % ) . a total of @ eligible patients were treated on the single agent arm with @ episodes of dvt and @ responses ( @ % ) . response rates were similar in patients with prior chemotherapy ( @ of @ ; @ % ) and those with no prior chemotherapy ( @ of @ ; @ % ) . two of four patients with clear cell carcinoma responded . adding the combination of megestrol acetate and tamoxifen to temsirolimus therapy did not enhance activity and the combination was associated with an excess of venous thrombosis . temsirolimus activity was preserved in patients with prior adjuvant chemotherapy .
24,456,823
[ "OBJECTIVE", "BACKGROUND", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "a link between poor sleep quality and alzheimer 's disease ( ad ) has recently been suggested .", "since endogenous melatonin levels are already reduced at preclinical ad stages , it is important to ask whether replenishing the missing hormone would be beneficial in ad and whether any such effects would be related to the presence of sleep disorder in patients .", "the effects of add-on prolonged-release melatonin ( prm ) ( @ mg ) to standard therapy on cognitive functioning and sleep were investigated in @ patients ( men -lsb- @ % -rsb- , women -lsb- @ % -rsb- , average age @ years -lsb- range , @-@ years -rsb- ) diagnosed with mild to moderate ad , with and without insomnia comorbidity , and receiving standard therapy ( acetylcholinesterase inhibitors with or without memantine ) .", "in this randomized , double-blind , parallel-group study , patients were treated for @ weeks with placebo and then randomized ( @:@ ) to receive @ mg of prm or placebo nightly for @ weeks , followed by @ weeks placebo .", "the ad assessment scale-cognition ( adas-cog ) , instrumental activities of daily living ( iadl ) , mini-mental state examination ( mmse ) , sleep , as assessed by the pittsburgh sleep quality index ( psqi ) and a daily sleep diary , and safety parameters were measured .", "patients treated with prm ( @ weeks ) had significantly better cognitive performance than those treated with placebo , as measured by the iadl ( p = @ ) and mmse ( p = @ ) .", "mean adas-cog did not differ between the groups .", "sleep efficiency , as measured by the psqi , component @ , was also better with prm ( p = @ ) .", "in the comorbid insomnia ( psqi @ ) subgroup , prm treatment resulted in significant and clinically meaningful effects versus the placebo , in mean iadl ( p = @ ) , mmse score ( +@ versus -@ points ) ( p = @ ) , and sleep efficiency ( p = @ ) .", "median adas-cog values ( -@ versus +@ points ) ( p = @ ) were significantly better with prm .", "differences were more significant at longer treatment duration .", "prm was well tolerated , with an adverse event profile similar to that of placebo .", "add-on prm has positive effects on cognitive functioning and sleep maintenance in ad patients compared with placebo , particularly in those with insomnia comorbidity .", "the results suggest a possible causal link between poor sleep and cognitive decline ." ]
a link between poor sleep quality and alzheimer 's disease ( ad ) has recently been suggested . since endogenous melatonin levels are already reduced at preclinical ad stages , it is important to ask whether replenishing the missing hormone would be beneficial in ad and whether any such effects would be related to the presence of sleep disorder in patients . the effects of add-on prolonged-release melatonin ( prm ) ( @ mg ) to standard therapy on cognitive functioning and sleep were investigated in @ patients ( men -lsb- @ % -rsb- , women -lsb- @ % -rsb- , average age @ years -lsb- range , @-@ years -rsb- ) diagnosed with mild to moderate ad , with and without insomnia comorbidity , and receiving standard therapy ( acetylcholinesterase inhibitors with or without memantine ) . in this randomized , double-blind , parallel-group study , patients were treated for @ weeks with placebo and then randomized ( @:@ ) to receive @ mg of prm or placebo nightly for @ weeks , followed by @ weeks placebo . the ad assessment scale-cognition ( adas-cog ) , instrumental activities of daily living ( iadl ) , mini-mental state examination ( mmse ) , sleep , as assessed by the pittsburgh sleep quality index ( psqi ) and a daily sleep diary , and safety parameters were measured . patients treated with prm ( @ weeks ) had significantly better cognitive performance than those treated with placebo , as measured by the iadl ( p = @ ) and mmse ( p = @ ) . mean adas-cog did not differ between the groups . sleep efficiency , as measured by the psqi , component @ , was also better with prm ( p = @ ) . in the comorbid insomnia ( psqi @ ) subgroup , prm treatment resulted in significant and clinically meaningful effects versus the placebo , in mean iadl ( p = @ ) , mmse score ( +@ versus -@ points ) ( p = @ ) , and sleep efficiency ( p = @ ) . median adas-cog values ( -@ versus +@ points ) ( p = @ ) were significantly better with prm . differences were more significant at longer treatment duration . prm was well tolerated , with an adverse event profile similar to that of placebo . add-on prm has positive effects on cognitive functioning and sleep maintenance in ad patients compared with placebo , particularly in those with insomnia comorbidity . the results suggest a possible causal link between poor sleep and cognitive decline .
24,971,004
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "ards is a heterogeneous syndrome that encompasses lung injury from both direct and indirect sources .", "direct ards ( pneumonia , aspiration ) has been hypothesized to cause more severe lung epithelial injury than indirect ards ( eg , nonpulmonary sepsis ) ; however , this hypothesis has not been well studied in humans .", "we measured plasma biomarkers of lung epithelial and endothelial injury and inflammation in a single-center study of @ patients with ards and severe sepsis and in a secondary analysis of @ patients with ards drawn from a multicenter randomized controlled trial .", "biomarker levels in patients with direct vs indirect ards were compared in both cohorts .", "in both studies , patients with direct ards had significantly higher levels of a biomarker of lung epithelial injury ( surfactant protein d ) and significantly lower levels of a biomarker of endothelial injury ( angiopoietin-@ ) than those with indirect ards .", "these associations were robust to adjustment for severity of illness and ards severity .", "in the multicenter study , patients with direct ards also had lower levels of von willebrand factor antigen and il-@ and il-@ , markers of endothelial injury and inflammation , respectively .", "the prognostic value of the biomarkers was similar in direct and indirect ards .", "direct lung injury in humans is characterized by a molecular phenotype consistent with more severe lung epithelial injury and less severe endothelial injury .", "the opposite pattern was identified in indirect lung injury .", "clinical trials of novel therapies targeted specifically at the lung epithelium or endothelium may benefit from preferentially enrolling patients with direct and indirect ards , respectively ." ]
ards is a heterogeneous syndrome that encompasses lung injury from both direct and indirect sources . direct ards ( pneumonia , aspiration ) has been hypothesized to cause more severe lung epithelial injury than indirect ards ( eg , nonpulmonary sepsis ) ; however , this hypothesis has not been well studied in humans . we measured plasma biomarkers of lung epithelial and endothelial injury and inflammation in a single-center study of @ patients with ards and severe sepsis and in a secondary analysis of @ patients with ards drawn from a multicenter randomized controlled trial . biomarker levels in patients with direct vs indirect ards were compared in both cohorts . in both studies , patients with direct ards had significantly higher levels of a biomarker of lung epithelial injury ( surfactant protein d ) and significantly lower levels of a biomarker of endothelial injury ( angiopoietin-@ ) than those with indirect ards . these associations were robust to adjustment for severity of illness and ards severity . in the multicenter study , patients with direct ards also had lower levels of von willebrand factor antigen and il-@ and il-@ , markers of endothelial injury and inflammation , respectively . the prognostic value of the biomarkers was similar in direct and indirect ards . direct lung injury in humans is characterized by a molecular phenotype consistent with more severe lung epithelial injury and less severe endothelial injury . the opposite pattern was identified in indirect lung injury . clinical trials of novel therapies targeted specifically at the lung epithelium or endothelium may benefit from preferentially enrolling patients with direct and indirect ards , respectively .
26,033,126
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "this study aims to evaluate the effects of nasal packs on surgical success and related complications in septoplasty .", "thirty-eight patients ( @ males , @ females ; mean age , @ years , range @ to @ years ) were included in the study .", "septoplasty candidates were prospectively divided into two groups .", "nasal packing and transseptal suture technique was applied to patients in group @ ( n = @ ) and group @ ( n = @ ) , respectively .", "postoperative pain was assessed with the visual analog scale .", "the success of surgery was questioned using the nasal obstruction septoplasty effectiveness ( nose ) scale .", "surgical success was defined as a @ % decrease in the nose scores .", "there was no statistically significant difference in surgical success and complication rates between the groups ( p > @ ) .", "pain scores were significantly higher in group @ ( p = @ ) .", "our study results suggest that nasal pack use does not affect surgical success and complication rates in septoplasty .", "pack-free septoplasty with the transseptal suture technique is an effective method in the treatment of septal deviation ." ]
this study aims to evaluate the effects of nasal packs on surgical success and related complications in septoplasty . thirty-eight patients ( @ males , @ females ; mean age , @ years , range @ to @ years ) were included in the study . septoplasty candidates were prospectively divided into two groups . nasal packing and transseptal suture technique was applied to patients in group @ ( n = @ ) and group @ ( n = @ ) , respectively . postoperative pain was assessed with the visual analog scale . the success of surgery was questioned using the nasal obstruction septoplasty effectiveness ( nose ) scale . surgical success was defined as a @ % decrease in the nose scores . there was no statistically significant difference in surgical success and complication rates between the groups ( p > @ ) . pain scores were significantly higher in group @ ( p = @ ) . our study results suggest that nasal pack use does not affect surgical success and complication rates in septoplasty . pack-free septoplasty with the transseptal suture technique is an effective method in the treatment of septal deviation .
25,046,068
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to compare the nasal tube with face mask as interfaces for stabilization of very preterm infants at birth by using physiological measurements of leak , obstruction , and expired tidal volumes during positive pressure ventilation ( ppv ) .", "in the delivery room , @ infants < @ weeks gestation were allocated to receive respiratory support by nasal tube or face mask .", "respiratory function , heart rate , and oxygen saturation were measured .", "occurrence of obstruction , amount of leak , and tidal volumes were compared using a mann-whitney u test or a fisher exact test .", "the first @ minutes after initiation of ppv were analyzed ( @ inflations in the nasal tube group and @ inflations in the face mask group ) .", "spontaneous breathing coincided with ppv in @ % of nasal tube and @ % of face mask inflations .", "during inflations , higher leak was observed using nasal tube compared with face mask ( @ % -lsb- @ % -@ % -rsb- vs @ -lsb- @ % -@ % -rsb- ; p < @ ) .", "obstruction occurred more often ( @ % vs @ % ; p < @ ) .", "expired tidal volumes were significantly lower during inflations when using nasal tube compared with face mask ( @ -lsb- @-@ @ -rsb- vs @ -lsb- @-@ @ -rsb- ml/kg ; p < @ ) and when spontaneous breathing coincided with ppv ( @ -lsb- @-@ @ -rsb- vs @ -lsb- @-@ @ -rsb- ml/kg ; p < @ ) but were similar during breathing on continuous positive airway pressure ( @ -lsb- @-@ @ -rsb- vs @ -lsb- @-@ @ -rsb- ml/kg ; p > @ ) .", "heart rate was not significantly different between groups , but oxygen saturation was significantly lower in the nasal tube group the first @ minutes after start of respiratory support .", "the use of a nasal tube led to large leak , more obstruction , and inadequate tidal volumes compared with face mask .", "trial registration registered with the dutch trial registry ( ntr @ ) and the australia and new zealand clinical trials register ( actrn @ ) ." ]
to compare the nasal tube with face mask as interfaces for stabilization of very preterm infants at birth by using physiological measurements of leak , obstruction , and expired tidal volumes during positive pressure ventilation ( ppv ) . in the delivery room , @ infants < @ weeks gestation were allocated to receive respiratory support by nasal tube or face mask . respiratory function , heart rate , and oxygen saturation were measured . occurrence of obstruction , amount of leak , and tidal volumes were compared using a mann-whitney u test or a fisher exact test . the first @ minutes after initiation of ppv were analyzed ( @ inflations in the nasal tube group and @ inflations in the face mask group ) . spontaneous breathing coincided with ppv in @ % of nasal tube and @ % of face mask inflations . during inflations , higher leak was observed using nasal tube compared with face mask ( @ % -lsb- @ % -@ % -rsb- vs @ -lsb- @ % -@ % -rsb- ; p < @ ) . obstruction occurred more often ( @ % vs @ % ; p < @ ) . expired tidal volumes were significantly lower during inflations when using nasal tube compared with face mask ( @ -lsb- @-@ @ -rsb- vs @ -lsb- @-@ @ -rsb- ml/kg ; p < @ ) and when spontaneous breathing coincided with ppv ( @ -lsb- @-@ @ -rsb- vs @ -lsb- @-@ @ -rsb- ml/kg ; p < @ ) but were similar during breathing on continuous positive airway pressure ( @ -lsb- @-@ @ -rsb- vs @ -lsb- @-@ @ -rsb- ml/kg ; p > @ ) . heart rate was not significantly different between groups , but oxygen saturation was significantly lower in the nasal tube group the first @ minutes after start of respiratory support . the use of a nasal tube led to large leak , more obstruction , and inadequate tidal volumes compared with face mask . trial registration registered with the dutch trial registry ( ntr @ ) and the australia and new zealand clinical trials register ( actrn @ ) .
25,957,978
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]
[ "to evaluate the efficacy and safety of ospemifene , a novel selective oestrogen receptor modulator , in the treatment of vaginal dryness in postmenopausal women with vulvovaginal atrophy ( vva ) .", "a @ week , multicentre , randomised , double-blind , parallel-group phase iii study of women ( @-@ years ) with vva and self-reported vaginal dryness as their most bothersome symptom .", "the co-primary efficacy endpoints were the change from baseline to week @ in ( @ ) percentage of parabasal cells in the maturation index ( mi ) , ( @ ) percentage of superficial cells in the mi , ( @ ) vaginal ph , and ( @ ) severity of vaginal dryness .", "safety assessments included physical examination , cervical papanicolaou test and clinical laboratory analyses .", "endometrial thickness and histology was also assessed .", "a total of @ women were randomised to once-daily ospemifene @ mg/day ( n = @ ) or placebo ( n = @ ) .", "significant improvements in the percentages of parabasal and superficial cells in the mi and vaginal ph were observed with ospemifene compared with placebo ( p < @ for all parameters ) .", "the mean change from baseline in severity score of vaginal dryness reported by women receiving ospemifene compared with those receiving placebo approached statistical significance ( p = @ ) .", "improvements in each of the four co-primary endpoints with ospemifene were statistically significant compared to placebo in the per protocol population .", "the majority of treatment-emergent adverse events were considered mild to moderate in severity .", "once-daily oral ospemifene @ mg was effective for the treatment of vva in postmenopausal women with vaginal dryness ." ]
to evaluate the efficacy and safety of ospemifene , a novel selective oestrogen receptor modulator , in the treatment of vaginal dryness in postmenopausal women with vulvovaginal atrophy ( vva ) . a @ week , multicentre , randomised , double-blind , parallel-group phase iii study of women ( @-@ years ) with vva and self-reported vaginal dryness as their most bothersome symptom . the co-primary efficacy endpoints were the change from baseline to week @ in ( @ ) percentage of parabasal cells in the maturation index ( mi ) , ( @ ) percentage of superficial cells in the mi , ( @ ) vaginal ph , and ( @ ) severity of vaginal dryness . safety assessments included physical examination , cervical papanicolaou test and clinical laboratory analyses . endometrial thickness and histology was also assessed . a total of @ women were randomised to once-daily ospemifene @ mg/day ( n = @ ) or placebo ( n = @ ) . significant improvements in the percentages of parabasal and superficial cells in the mi and vaginal ph were observed with ospemifene compared with placebo ( p < @ for all parameters ) . the mean change from baseline in severity score of vaginal dryness reported by women receiving ospemifene compared with those receiving placebo approached statistical significance ( p = @ ) . improvements in each of the four co-primary endpoints with ospemifene were statistically significant compared to placebo in the per protocol population . the majority of treatment-emergent adverse events were considered mild to moderate in severity . once-daily oral ospemifene @ mg was effective for the treatment of vva in postmenopausal women with vaginal dryness .
24,679,891
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "guidelines recommend lopinavir/ritonavir ( lpv/r ) as first - and second-line therapy for young and older hiv-infected children , respectively .", "available formulations have limitations making their widespread use complex .", "an open-label comparative bioavailability ( randomized crossover ) study compared a novel twice-daily minitab sprinkle formulation ( @ mg/@ mg , cipla pharmaceuticals ) versus innovator syrup in hiv-infected ugandan infants aged @ to < @ months ( cohort a ) and children aged @-@ years ( cohort b ) and versus cipla tablets ( @/@ mg ) in children aged @ to < @ years ( cohort c ) .", "twelve-hour intensive pharmacokinetic sampling after observed lpv/r intake ( plus @ nucleoside reverse transcriptase inhibitors ) following world health organization @ dosing with food was performed @ weeks after enrollment .", "children then switched formulation ; sampling was repeated at week @ .", "acceptability data were also collected .", "seventy-seven infants/children were included in cohort a ( n = @ ) / b ( n = @ ) / c ( n = @ ) .", "among @ evaluable pharmacokinetic profiles , there were @/@/@ within-child comparisons in cohort a/b/c .", "for minitabs versus syrup , geometric mean -lsb- @ % confidence interval ( ci ) -rsb- auc@-@h was @ ( @-@ @ ) versus @ ( @-@ @ ) hmg/l in cohort a -lsb- geometric mean ratio ( gmr ) ( @ % ci ) = @ ( @ to @ ) -rsb- and @ ( @ to @ ) versus @ ( @ to @ ) hmg/l in cohort b -lsb- gmr ( @ % ci ) = @ ( @ to @ ) -rsb- .", "for minitabs versus tablets , geometric mean ( @ % ci ) auc@-@h was @ ( @ to @ ) versus @ ( @ to @ ) hmg/l ; gmr ( @ % ci ) = @ ( @ to @ ) .", "subtherapeutic levels ( < @ mg/l ) occurred in @ ( @ % ) / @ ( @ % ) minitabs/syrup in infants ( p = @ ) , no children aged @-@ years and @ ( @ % ) / @ ( @ % ) minitabs/tablets ( p = @ ) .", "about @/@ ( @ % ) and @/@ ( @ % ) caregivers of infants and children aged @-@ years , respectively , chose to continue minitabs after week @ , mainly for convenience ; only @/@ ( @ % ) older children ( five < @ years ) remained on minitabs .", "lpv/r exposure from minitabs was comparable with syrup , but lower than tablets , with no significant differences in subtherapeutic concentrations .", "minitabs were more acceptable than syrups for younger children , but older children preferred tablets ." ]
guidelines recommend lopinavir/ritonavir ( lpv/r ) as first - and second-line therapy for young and older hiv-infected children , respectively . available formulations have limitations making their widespread use complex . an open-label comparative bioavailability ( randomized crossover ) study compared a novel twice-daily minitab sprinkle formulation ( @ mg/@ mg , cipla pharmaceuticals ) versus innovator syrup in hiv-infected ugandan infants aged @ to < @ months ( cohort a ) and children aged @-@ years ( cohort b ) and versus cipla tablets ( @/@ mg ) in children aged @ to < @ years ( cohort c ) . twelve-hour intensive pharmacokinetic sampling after observed lpv/r intake ( plus @ nucleoside reverse transcriptase inhibitors ) following world health organization @ dosing with food was performed @ weeks after enrollment . children then switched formulation ; sampling was repeated at week @ . acceptability data were also collected . seventy-seven infants/children were included in cohort a ( n = @ ) / b ( n = @ ) / c ( n = @ ) . among @ evaluable pharmacokinetic profiles , there were @/@/@ within-child comparisons in cohort a/b/c . for minitabs versus syrup , geometric mean -lsb- @ % confidence interval ( ci ) -rsb- auc@-@h was @ ( @-@ @ ) versus @ ( @-@ @ ) hmg/l in cohort a -lsb- geometric mean ratio ( gmr ) ( @ % ci ) = @ ( @ to @ ) -rsb- and @ ( @ to @ ) versus @ ( @ to @ ) hmg/l in cohort b -lsb- gmr ( @ % ci ) = @ ( @ to @ ) -rsb- . for minitabs versus tablets , geometric mean ( @ % ci ) auc@-@h was @ ( @ to @ ) versus @ ( @ to @ ) hmg/l ; gmr ( @ % ci ) = @ ( @ to @ ) . subtherapeutic levels ( < @ mg/l ) occurred in @ ( @ % ) / @ ( @ % ) minitabs/syrup in infants ( p = @ ) , no children aged @-@ years and @ ( @ % ) / @ ( @ % ) minitabs/tablets ( p = @ ) . about @/@ ( @ % ) and @/@ ( @ % ) caregivers of infants and children aged @-@ years , respectively , chose to continue minitabs after week @ , mainly for convenience ; only @/@ ( @ % ) older children ( five < @ years ) remained on minitabs . lpv/r exposure from minitabs was comparable with syrup , but lower than tablets , with no significant differences in subtherapeutic concentrations . minitabs were more acceptable than syrups for younger children , but older children preferred tablets .
24,828,266
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "mindfulness-based interventions may be acceptable to veterans who have poor adherence to existing evidence-based treatments for posttraumatic stress disorder ( ptsd ) .", "to compare mindfulness-based stress reduction with present-centered group therapy for treatment of ptsd .", "randomized clinical trial of @ veterans with ptsd recruited at the minneapolis veterans affairs medical center from march @ to december @ .", "outcomes were assessed before , during , and after treatment and at @-month follow-up .", "data collection was completed on april @ , @ .", "participants were randomly assigned to receive mindfulness-based stress reduction therapy ( n = @ ) , consisting of @ sessions ( @ weekly @-hour group sessions and a daylong retreat ) focused on teaching patients to attend to the present moment in a nonjudgmental , accepting manner ; or present-centered group therapy ( n = @ ) , an active-control condition consisting of @ weekly @-hour group sessions focused on current life problems .", "the primary outcome , change in ptsd symptom severity over time , was assessed using the ptsd checklist ( range , @-@ ; higher scores indicate greater severity ; reduction of @ or more considered a minimal clinically important difference ) at baseline and weeks @ , @ , @ , and @ .", "secondary outcomes included ptsd diagnosis and symptom severity assessed by independent evaluators using the clinician-administered ptsd scale along with improvements in depressive symptoms , quality of life , and mindfulness .", "participants in the mindfulness-based stress reduction group demonstrated greater improvement in self-reported ptsd symptom severity during treatment ( change in mean ptsd checklist scores from @ to @ vs @ to @ with present-centered group therapy ; between-group difference , @ ; @ % ci , @-@ @ ; p = @ ) and at @-month follow-up ( change in mean scores from @ to @ vs @ to @ , respectively ; difference , @ ; @ % ci , @-@ @ , p < @ ) .", "although participants in the mindfulness-based stress reduction group were more likely to show clinically significant improvement in self-reported ptsd symptom severity ( @ % vs @ % with present-centered group therapy ; difference , @ % ; @ % ci , @ % -@ % ; p = @ ) at @-month follow-up , they were no more likely to have loss of ptsd diagnosis ( @ % vs @ % , respectively ; difference , @ % ; @ % ci , -@ % to @ % ; p = @ ) .", "among veterans with ptsd , mindfulness-based stress reduction therapy , compared with present-centered group therapy , resulted in a greater decrease in ptsd symptom severity .", "however , the magnitude of the average improvement suggests a modest effect .", "clinicaltrials.gov identifier : nct@ ." ]
mindfulness-based interventions may be acceptable to veterans who have poor adherence to existing evidence-based treatments for posttraumatic stress disorder ( ptsd ) . to compare mindfulness-based stress reduction with present-centered group therapy for treatment of ptsd . randomized clinical trial of @ veterans with ptsd recruited at the minneapolis veterans affairs medical center from march @ to december @ . outcomes were assessed before , during , and after treatment and at @-month follow-up . data collection was completed on april @ , @ . participants were randomly assigned to receive mindfulness-based stress reduction therapy ( n = @ ) , consisting of @ sessions ( @ weekly @-hour group sessions and a daylong retreat ) focused on teaching patients to attend to the present moment in a nonjudgmental , accepting manner ; or present-centered group therapy ( n = @ ) , an active-control condition consisting of @ weekly @-hour group sessions focused on current life problems . the primary outcome , change in ptsd symptom severity over time , was assessed using the ptsd checklist ( range , @-@ ; higher scores indicate greater severity ; reduction of @ or more considered a minimal clinically important difference ) at baseline and weeks @ , @ , @ , and @ . secondary outcomes included ptsd diagnosis and symptom severity assessed by independent evaluators using the clinician-administered ptsd scale along with improvements in depressive symptoms , quality of life , and mindfulness . participants in the mindfulness-based stress reduction group demonstrated greater improvement in self-reported ptsd symptom severity during treatment ( change in mean ptsd checklist scores from @ to @ vs @ to @ with present-centered group therapy ; between-group difference , @ ; @ % ci , @-@ @ ; p = @ ) and at @-month follow-up ( change in mean scores from @ to @ vs @ to @ , respectively ; difference , @ ; @ % ci , @-@ @ , p < @ ) . although participants in the mindfulness-based stress reduction group were more likely to show clinically significant improvement in self-reported ptsd symptom severity ( @ % vs @ % with present-centered group therapy ; difference , @ % ; @ % ci , @ % -@ % ; p = @ ) at @-month follow-up , they were no more likely to have loss of ptsd diagnosis ( @ % vs @ % , respectively ; difference , @ % ; @ % ci , -@ % to @ % ; p = @ ) . among veterans with ptsd , mindfulness-based stress reduction therapy , compared with present-centered group therapy , resulted in a greater decrease in ptsd symptom severity . however , the magnitude of the average improvement suggests a modest effect . clinicaltrials.gov identifier : nct@ .
26,241,597
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "the relationship between tobacco and cannabis use is strong .", "when co-smokers try to quit only one substance , this relationship often leads to a substitution effect , that is , the increased use of the remaining substance .", "stopping the use of both substances simultaneously is therefore a reasonable strategy , but co-smokers rarely report feeling ready for simultaneous cessation .", "thus , the question of how co-smokers can be motivated to attempt a simultaneous cessation has arisen .", "to reach as many co-smokers as possible , we developed brief web-based interventions aimed at enhancing the readiness to simultaneously quit tobacco and cannabis use .", "our aim was to analyze the efficacy of three different web-based interventions designed to enhance co-smokers ' readiness to stop tobacco and cannabis use simultaneously .", "within a randomized trial , three brief web-based and fully automated interventions were compared .", "the first intervention combined the assessment of cigarette dependence and problematic cannabis use with personalized , normative feedback .", "the second intervention was based on principles of motivational interviewing .", "as an active psychoeducational control group , the third intervention merely provided information on tobacco , cannabis , and the co-use of the two substances .", "the readiness to quit tobacco and cannabis simultaneously was measured before and after the intervention ( both online ) and @ weeks later ( online or over the phone ) .", "secondary outcomes included the frequency of cigarette and cannabis use , as measured at baseline and after @ weeks .", "a total of @ website users were assessed for eligibility based on their self-reported tobacco and cannabis co-use , and @ participants were ultimately randomized and analyzed .", "for the post-intervention assessment , generalized estimating equations revealed a significant increase in the readiness to quit tobacco and cannabis in the total sample ( b = @ , @ % ci @-@ @ , p = @ ) .", "however , this effect was not significant for the comparison between baseline and the @-week follow-up assessment ( p = @ ) .", "furthermore , no differential effects between the interventions were found , nor were any significant intervention or time effects found on the frequency of tobacco or cannabis use .", "in the new field of dual interventions for co-smokers of tobacco and cannabis , web-based interventions can increase the short-term readiness to quit tobacco and cannabis simultaneously .", "the studied personalized techniques were no more effective than was psychoeducation .", "the analyzed brief interventions did not change the secondary outcomes , that is the frequency of tobacco and cannabis use .", "international standard randomized controlled trial number ( isrctn ) : @ ; http://www.isrctn.com/isrctn@ ( archived by webcite at http://www.webcitation.org/@uuwbh@u@ ) ." ]
the relationship between tobacco and cannabis use is strong . when co-smokers try to quit only one substance , this relationship often leads to a substitution effect , that is , the increased use of the remaining substance . stopping the use of both substances simultaneously is therefore a reasonable strategy , but co-smokers rarely report feeling ready for simultaneous cessation . thus , the question of how co-smokers can be motivated to attempt a simultaneous cessation has arisen . to reach as many co-smokers as possible , we developed brief web-based interventions aimed at enhancing the readiness to simultaneously quit tobacco and cannabis use . our aim was to analyze the efficacy of three different web-based interventions designed to enhance co-smokers ' readiness to stop tobacco and cannabis use simultaneously . within a randomized trial , three brief web-based and fully automated interventions were compared . the first intervention combined the assessment of cigarette dependence and problematic cannabis use with personalized , normative feedback . the second intervention was based on principles of motivational interviewing . as an active psychoeducational control group , the third intervention merely provided information on tobacco , cannabis , and the co-use of the two substances . the readiness to quit tobacco and cannabis simultaneously was measured before and after the intervention ( both online ) and @ weeks later ( online or over the phone ) . secondary outcomes included the frequency of cigarette and cannabis use , as measured at baseline and after @ weeks . a total of @ website users were assessed for eligibility based on their self-reported tobacco and cannabis co-use , and @ participants were ultimately randomized and analyzed . for the post-intervention assessment , generalized estimating equations revealed a significant increase in the readiness to quit tobacco and cannabis in the total sample ( b = @ , @ % ci @-@ @ , p = @ ) . however , this effect was not significant for the comparison between baseline and the @-week follow-up assessment ( p = @ ) . furthermore , no differential effects between the interventions were found , nor were any significant intervention or time effects found on the frequency of tobacco or cannabis use . in the new field of dual interventions for co-smokers of tobacco and cannabis , web-based interventions can increase the short-term readiness to quit tobacco and cannabis simultaneously . the studied personalized techniques were no more effective than was psychoeducation . the analyzed brief interventions did not change the secondary outcomes , that is the frequency of tobacco and cannabis use . international standard randomized controlled trial number ( isrctn ) : @ ; http://www.isrctn.com/isrctn@ ( archived by webcite at http://www.webcitation.org/@uuwbh@u@ ) .
25,486,674
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "to evaluate the clinical effects of yuleshu oral mixture combined with conventional therapy on chronic prostatitis .", "eighty-eight patients with chronic prostatitis/chronic pelvic pain syndrome ( cp/cpps ) were equally randomized to a control and an experimental group to receive conventional therapy ( oral antibiotics , alpha blockers , proprietary chinese medicine for activating blood circulation and massage of the prostate ) and conventional therapy combined with yuleshu oral mixture respectively .", "before and after treatment , the severity of symptoms and sexual function of the patients were evaluated using nih-cpsi and iief-@ , their anxiety , depression and other emotional problems assessed with hamilton depression rating scale ( hamd ) and hamilton anxiety scale ( hama ) , and the results subjected to statistical analysis .", "both the experimental and control groups showed significant improvement in prostatitis symptoms and sexual function after treatment as compared with the baseline ( p < @ ) , even more significant in the former than in the latter group , especially in pain symptoms ( @ + / - @ vs @ + / - @ , p < @ ) .", "before and after treatment , the hama and hamd score had no significant difference in the control , but there was significant difference in the experimental group .", "the experimental group exhibited remarkably higher scores after than before treatment on hama ( @ + / - @ vs @ + / - @ , p < @ ) and hamd ( @ + / - @ vs @ + / - @ , p < @ ) , but not the control group ( p > @ ) .", "yuleshu oral mixture can effectively relieve anxiety , depression and other psychological problems in cp/cpps patients , and improve their clinical symptoms as well .", "therefore , it is an effective drug for chronic prostatitis ." ]
to evaluate the clinical effects of yuleshu oral mixture combined with conventional therapy on chronic prostatitis . eighty-eight patients with chronic prostatitis/chronic pelvic pain syndrome ( cp/cpps ) were equally randomized to a control and an experimental group to receive conventional therapy ( oral antibiotics , alpha blockers , proprietary chinese medicine for activating blood circulation and massage of the prostate ) and conventional therapy combined with yuleshu oral mixture respectively . before and after treatment , the severity of symptoms and sexual function of the patients were evaluated using nih-cpsi and iief-@ , their anxiety , depression and other emotional problems assessed with hamilton depression rating scale ( hamd ) and hamilton anxiety scale ( hama ) , and the results subjected to statistical analysis . both the experimental and control groups showed significant improvement in prostatitis symptoms and sexual function after treatment as compared with the baseline ( p < @ ) , even more significant in the former than in the latter group , especially in pain symptoms ( @ + / - @ vs @ + / - @ , p < @ ) . before and after treatment , the hama and hamd score had no significant difference in the control , but there was significant difference in the experimental group . the experimental group exhibited remarkably higher scores after than before treatment on hama ( @ + / - @ vs @ + / - @ , p < @ ) and hamd ( @ + / - @ vs @ + / - @ , p < @ ) , but not the control group ( p > @ ) . yuleshu oral mixture can effectively relieve anxiety , depression and other psychological problems in cp/cpps patients , and improve their clinical symptoms as well . therefore , it is an effective drug for chronic prostatitis .
24,520,674
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to investigate clinical efficacy and safety of @ certolizumab pegol ( czp ) maintenance dosing regimens plus methotrexate ( mtx ) in active rheumatoid arthritis ( ra ) patients achieving the american college of rheumatology @ % improvement criteria ( acr@ ) after the czp @ mg every @ weeks open-label run-in period .", "doseflex ( dosing flexibility ) was a double-blind , placebo-controlled randomized study with an open-label run-in phase .", "during the run-in phase , all patients received czp @ mg ( weeks @ , @ , and @ ) and @ mg every @ weeks to week @ .", "week @ acr@ responders were randomized @:@:@ at week @ to czp @ mg every @ weeks , @ mg every @ weeks , or placebo .", "a total of @ ( of @ ) patients were randomized at week @ ( czp : @ mg , n = @ ; @ mg , n = @ ; placebo , n = @ ) .", "groups had similar baseline characteristics ( week @ ) .", "week @ acr@ response rates were comparable between the czp @ mg every @ weeks and the @ mg every @ weeks groups ( @ % versus @ % ) , which was significantly higher than placebo ( @ % ; p = @ and p = @ ) .", "acr@/@ and remission criteria were met more frequently in czp groups than placebo at week @ , with similar responses between anti-tumor necrosis factor-experienced and naive patients .", "improvements from baseline disease activity score in @ joints using the erythrocyte sedimentation rate and health assessment questionnaire disability index scores were maintained in czp groups from week @ to @ while worsening on placebo .", "adverse event ( ae ) rates in the double-blind phase were @ % versus @ % versus @ % ; serious ae rates were @ % versus @ % versus @ % ( czp @ mg , @ mg , and placebo groups ) .", "in active ra patients with an incomplete mtx response , czp @ mg every @ weeks and @ mg every @ weeks were comparable and better than placebo for maintaining clinical response to week @ following a @-week , open-label run-in phase ." ]
to investigate clinical efficacy and safety of @ certolizumab pegol ( czp ) maintenance dosing regimens plus methotrexate ( mtx ) in active rheumatoid arthritis ( ra ) patients achieving the american college of rheumatology @ % improvement criteria ( acr@ ) after the czp @ mg every @ weeks open-label run-in period . doseflex ( dosing flexibility ) was a double-blind , placebo-controlled randomized study with an open-label run-in phase . during the run-in phase , all patients received czp @ mg ( weeks @ , @ , and @ ) and @ mg every @ weeks to week @ . week @ acr@ responders were randomized @:@:@ at week @ to czp @ mg every @ weeks , @ mg every @ weeks , or placebo . a total of @ ( of @ ) patients were randomized at week @ ( czp : @ mg , n = @ ; @ mg , n = @ ; placebo , n = @ ) . groups had similar baseline characteristics ( week @ ) . week @ acr@ response rates were comparable between the czp @ mg every @ weeks and the @ mg every @ weeks groups ( @ % versus @ % ) , which was significantly higher than placebo ( @ % ; p = @ and p = @ ) . acr@/@ and remission criteria were met more frequently in czp groups than placebo at week @ , with similar responses between anti-tumor necrosis factor-experienced and naive patients . improvements from baseline disease activity score in @ joints using the erythrocyte sedimentation rate and health assessment questionnaire disability index scores were maintained in czp groups from week @ to @ while worsening on placebo . adverse event ( ae ) rates in the double-blind phase were @ % versus @ % versus @ % ; serious ae rates were @ % versus @ % versus @ % ( czp @ mg , @ mg , and placebo groups ) . in active ra patients with an incomplete mtx response , czp @ mg every @ weeks and @ mg every @ weeks were comparable and better than placebo for maintaining clinical response to week @ following a @-week , open-label run-in phase .
25,302,624
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the goal of this study was to evaluate the effectiveness of nebulized beclomethasone in preventing the recurrence of viral wheezing .", "the study was designed as a randomized , double-blind , placebo-controlled trial .", "outpatient children aged @ to @ years with at least @ episode of viral wheezing in the last @ months , presenting to any of @ italian pediatricians for an upper respiratory tract infection , were randomly allocated to receive beclomethasone @ g or placebo twice daily for @ days .", "medications were administered through a nebulizer .", "a clinical evaluation was performed by the pediatrician at the start and end of the treatment period .", "a subjective evaluation of symptoms and efficacy of treatment was performed by the parents .", "the primary endpoint was the incidence of viral wheezing diagnosed by the pediatricians during the @-day treatment period .", "a total of @ children were enrolled in the study , @ of whom were visited at the end of the treatment period .", "wheezing was diagnosed by the pediatricians in @ children ( @ % -lsb- @ % confidence interval : @ to @ -rsb- ) , with no statistically significant differences between treatment groups ( beclomethasone versus placebo relative risk : @ -lsb- @ % confidence interval : @ to @ -rsb- ) .", "the treatment was considered helpful by @ % of parents ( @ % in the beclomethasone group vs @ % in the placebo group ) .", "in all , @ % of children still had infection symptoms at the end of the treatment period , with no differences between groups .", "the findings from this study confirm that inhaled steroids are not effective in preventing recurrence of viral wheezing .", "moreover , no benefits were found in reducing symptoms of respiratory tract infections ." ]
the goal of this study was to evaluate the effectiveness of nebulized beclomethasone in preventing the recurrence of viral wheezing . the study was designed as a randomized , double-blind , placebo-controlled trial . outpatient children aged @ to @ years with at least @ episode of viral wheezing in the last @ months , presenting to any of @ italian pediatricians for an upper respiratory tract infection , were randomly allocated to receive beclomethasone @ g or placebo twice daily for @ days . medications were administered through a nebulizer . a clinical evaluation was performed by the pediatrician at the start and end of the treatment period . a subjective evaluation of symptoms and efficacy of treatment was performed by the parents . the primary endpoint was the incidence of viral wheezing diagnosed by the pediatricians during the @-day treatment period . a total of @ children were enrolled in the study , @ of whom were visited at the end of the treatment period . wheezing was diagnosed by the pediatricians in @ children ( @ % -lsb- @ % confidence interval : @ to @ -rsb- ) , with no statistically significant differences between treatment groups ( beclomethasone versus placebo relative risk : @ -lsb- @ % confidence interval : @ to @ -rsb- ) . the treatment was considered helpful by @ % of parents ( @ % in the beclomethasone group vs @ % in the placebo group ) . in all , @ % of children still had infection symptoms at the end of the treatment period , with no differences between groups . the findings from this study confirm that inhaled steroids are not effective in preventing recurrence of viral wheezing . moreover , no benefits were found in reducing symptoms of respiratory tract infections .
24,534,400
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to examine the effect of repeated-sprint training ( rst ) vs combined rst and resistance training with superimposed vibrations on repeated-sprint ability ( rsa ) and lower-body power output in male rugby players .", "players were divided into @ training groups .", "one group performed rst ( n = @ ) @ d/wk and the other performed rst @ d/wk and squat resistance training with superimposed vibrations on the second day ( rs+st ; n = @ ) .", "the squat training was carried out with a volume similar ( ie , number of sets and repetitions ) to that of the rst .", "the training period lasted @ wk , and it was carried out as a supplement to the regular rugby training sessions .", "substantial improvements in rsa mean time ( rsa ( mean ) ; +@ % / es : @ vs +@ % / es : @ ) , rsa percent decrement ( % dec ; -@ % / es : @ vs -@ % / es : @ ) , and squat absolute power output ( +@ % / es :@ vs +@ % / es : @ ) were obtained in rst and rs+st , respectively .", "substantial improvements in rsa best time ( rsa ( best ) ; +@ % / es : @ ) and squat power output normalized to body mass ( +@ % / es : @ ) only occurred in rs+st .", "both pretest and posttest rsa ( mean ) were largely correlated with the rsa ( best ) .", "however , there were only unclear , small to moderate correlations between individual changes in squat power output and either rsa ( mean ) or rsa ( best ) .", "combined rst and resistance training induced improvements of greater magnitude in both repeated-sprint performance and muscle power output than the rst alone .", "the lack of substantial correlations between individual changes in repeated-sprint and muscle-power performance suggests that the same subjects were not systematically low or high responders to both rst and strength training ." ]
to examine the effect of repeated-sprint training ( rst ) vs combined rst and resistance training with superimposed vibrations on repeated-sprint ability ( rsa ) and lower-body power output in male rugby players . players were divided into @ training groups . one group performed rst ( n = @ ) @ d/wk and the other performed rst @ d/wk and squat resistance training with superimposed vibrations on the second day ( rs+st ; n = @ ) . the squat training was carried out with a volume similar ( ie , number of sets and repetitions ) to that of the rst . the training period lasted @ wk , and it was carried out as a supplement to the regular rugby training sessions . substantial improvements in rsa mean time ( rsa ( mean ) ; +@ % / es : @ vs +@ % / es : @ ) , rsa percent decrement ( % dec ; -@ % / es : @ vs -@ % / es : @ ) , and squat absolute power output ( +@ % / es :@ vs +@ % / es : @ ) were obtained in rst and rs+st , respectively . substantial improvements in rsa best time ( rsa ( best ) ; +@ % / es : @ ) and squat power output normalized to body mass ( +@ % / es : @ ) only occurred in rs+st . both pretest and posttest rsa ( mean ) were largely correlated with the rsa ( best ) . however , there were only unclear , small to moderate correlations between individual changes in squat power output and either rsa ( mean ) or rsa ( best ) . combined rst and resistance training induced improvements of greater magnitude in both repeated-sprint performance and muscle power output than the rst alone . the lack of substantial correlations between individual changes in repeated-sprint and muscle-power performance suggests that the same subjects were not systematically low or high responders to both rst and strength training .
24,231,555
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the relative performance of art sealant and fluoride-releasing resin sealant in preventing fissure caries in permanent molars was compared in a randomized clinical trial conducted in southern china ( clinicaltrials.gov nct@ ) .", "after obtaining ethical approval , healthy schoolchildren who had permanent first molars with occlusal fissures which were sound but deep or presented with only incipient caries were recruited for the study .", "included molars were randomly allocated into one of four parallel study groups in units of left/right teeth per mouth .", "two of the four groups adopted the methods of art or fluoride-releasing resin sealant placement while the other two groups adopted the topical fluoride application methods .", "fissure status of the molars in each group was evaluated every @ months .", "development of dentine caries and sealant retention over @ months in the molars in the two sealant-using groups was compared in this report .", "outcome on cost-effectiveness of all four groups over @ months will be reported elsewhere .", "at baseline , a total of @ children ( @ molars ) with mean age @ years were involved for the two sealant groups .", "after @ months , @ children ( @ molars ) were followed .", "proportions of molars with dentine caries were @ % and @ % in the art sealant and fluoride-releasing resin sealant groups , respectively ( chi-square test , p = @ ) .", "life-table survival analysis showed that sealant retention ( full and partial ) rate over @ months for the resin sealant ( @ % ) was significantly higher than that ( @ % ) for the art sealant ( p < @ ) .", "molar survival ( no development of dentine caries ) rates in the art sealant ( @ % ) and fluoride-releasing resin sealant ( @ % ) groups were not significantly different ( p = @ ) .", "multilevel logistic regression ( gee modeling ) accounting for the effects of data clustering and confounding factors confirmed this finding .", "though the retention of fluoride-releasing resin sealant was better than that of the art sealant , their effectiveness in preventing fissure caries in permanent molars did not differ significantly over @ months .", "art sealants could be a good alternative when and where resources for resin sealant placement are not readily available ." ]
the relative performance of art sealant and fluoride-releasing resin sealant in preventing fissure caries in permanent molars was compared in a randomized clinical trial conducted in southern china ( clinicaltrials.gov nct@ ) . after obtaining ethical approval , healthy schoolchildren who had permanent first molars with occlusal fissures which were sound but deep or presented with only incipient caries were recruited for the study . included molars were randomly allocated into one of four parallel study groups in units of left/right teeth per mouth . two of the four groups adopted the methods of art or fluoride-releasing resin sealant placement while the other two groups adopted the topical fluoride application methods . fissure status of the molars in each group was evaluated every @ months . development of dentine caries and sealant retention over @ months in the molars in the two sealant-using groups was compared in this report . outcome on cost-effectiveness of all four groups over @ months will be reported elsewhere . at baseline , a total of @ children ( @ molars ) with mean age @ years were involved for the two sealant groups . after @ months , @ children ( @ molars ) were followed . proportions of molars with dentine caries were @ % and @ % in the art sealant and fluoride-releasing resin sealant groups , respectively ( chi-square test , p = @ ) . life-table survival analysis showed that sealant retention ( full and partial ) rate over @ months for the resin sealant ( @ % ) was significantly higher than that ( @ % ) for the art sealant ( p < @ ) . molar survival ( no development of dentine caries ) rates in the art sealant ( @ % ) and fluoride-releasing resin sealant ( @ % ) groups were not significantly different ( p = @ ) . multilevel logistic regression ( gee modeling ) accounting for the effects of data clustering and confounding factors confirmed this finding . though the retention of fluoride-releasing resin sealant was better than that of the art sealant , their effectiveness in preventing fissure caries in permanent molars did not differ significantly over @ months . art sealants could be a good alternative when and where resources for resin sealant placement are not readily available .
24,886,444
[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "introduction of calcineurin inhibitors had led to improved survival rates in liver transplant recipients .", "however , long-term use of calcineurin inhibitors is associated with a higher risk of chronic renal failure , neurotoxicity , de novo malignancies , recurrence of hepatitis c viral ( hcv ) infection and hepatocellular carcinoma .", "several studies have shown that everolimus has the potential to provide protection against viral replication , malignancy , and progression of fibrosis , as well as preventing nephrotoxicity by facilitating calcineurin inhibitor reduction without compromising efficacy .", "the hephaistos study evaluates the beneficial effects of early initiation of everolimus in de novo liver transplant recipients .", "hephaistos is an ongoing @-month , multi-center , open-label , controlled study aiming to enroll @ de novo liver transplant recipients from @ centers across germany .", "patients are randomized in a @:@ ratio ( @-@days post-transplantation ) to receive everolimus ( trough levels @-@ng / ml ) with reduced tacrolimus ( trough levels < @ng/ml ) , or standard tacrolimus ( trough levels @-@ng / ml ) after entering a run-in period ( @-@days post-transplantation ) .", "in the run-in period , patients are treated with induction therapy , mycophenolate mofetil , tacrolimus , and corticosteroids according to local practice .", "randomization is stratified by hcv status and model of end-stage liver disease scores at transplantation .", "the primary objective of the study is to exhibit superior renal function ( estimated glomerular filtration rate assessed by the modification of diet in renal disease ( mdrd ) -@ formula ) with everolimus plus reduced tacrolimus compared to standard tacrolimus at month @ .", "other objectives are : to assess the incidence of treated biopsy-proven acute rejection , graft loss , or death ; the incidences of components of the composite efficacy endpoint ; renal function via estimated glomerular filtration rate using various formulae ( mdrd-@ , nankivell , cockcroft-gault , chronic kidney disease epidemiology collaboration and hoek formulae ) ; the incidence of proteinuria ; the incidence of adverse events and serious adverse events ; the incidence and severity of cytomegalovirus and hcv infections and hcv-related fibrosis .", "this study aims to demonstrate superior renal function , comparable efficacy , and safety in de novo liver transplant recipients receiving everolimus with reduced tacrolimus compared with standard tacrolimus .", "this study also evaluates the antiviral benefit by early initiation of everolimus .", "nct@ ." ]
introduction of calcineurin inhibitors had led to improved survival rates in liver transplant recipients . however , long-term use of calcineurin inhibitors is associated with a higher risk of chronic renal failure , neurotoxicity , de novo malignancies , recurrence of hepatitis c viral ( hcv ) infection and hepatocellular carcinoma . several studies have shown that everolimus has the potential to provide protection against viral replication , malignancy , and progression of fibrosis , as well as preventing nephrotoxicity by facilitating calcineurin inhibitor reduction without compromising efficacy . the hephaistos study evaluates the beneficial effects of early initiation of everolimus in de novo liver transplant recipients . hephaistos is an ongoing @-month , multi-center , open-label , controlled study aiming to enroll @ de novo liver transplant recipients from @ centers across germany . patients are randomized in a @:@ ratio ( @-@days post-transplantation ) to receive everolimus ( trough levels @-@ng / ml ) with reduced tacrolimus ( trough levels < @ng/ml ) , or standard tacrolimus ( trough levels @-@ng / ml ) after entering a run-in period ( @-@days post-transplantation ) . in the run-in period , patients are treated with induction therapy , mycophenolate mofetil , tacrolimus , and corticosteroids according to local practice . randomization is stratified by hcv status and model of end-stage liver disease scores at transplantation . the primary objective of the study is to exhibit superior renal function ( estimated glomerular filtration rate assessed by the modification of diet in renal disease ( mdrd ) -@ formula ) with everolimus plus reduced tacrolimus compared to standard tacrolimus at month @ . other objectives are : to assess the incidence of treated biopsy-proven acute rejection , graft loss , or death ; the incidences of components of the composite efficacy endpoint ; renal function via estimated glomerular filtration rate using various formulae ( mdrd-@ , nankivell , cockcroft-gault , chronic kidney disease epidemiology collaboration and hoek formulae ) ; the incidence of proteinuria ; the incidence of adverse events and serious adverse events ; the incidence and severity of cytomegalovirus and hcv infections and hcv-related fibrosis . this study aims to demonstrate superior renal function , comparable efficacy , and safety in de novo liver transplant recipients receiving everolimus with reduced tacrolimus compared with standard tacrolimus . this study also evaluates the antiviral benefit by early initiation of everolimus . nct@ .
25,873,064
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "to compare the hemostatic effects of local packing of nasopore combined with hemocoagulase injection and local packing of nasopore combined with saline injection for postoperative management of functional endoscopic sinus surgery by a double-blind , randomized control clinical trial .", "sixty-eight cases of chronic sinusitis needed functional endoscopic sinus surgery were randomly divided into the experimental group of @ cases and control group of @ cases , respectively .", "for the experimental group , @ u of hemocoagulase dissolved in @ ml saline was injected into nasopore which was packed into the nasal cavity after operation .", "for the control group , @ ml of saline was injected .", "the postoperative bleeding of the two groups were scored by visual analogue scale .", "there was statistically significant difference between the bleeding vas scores assessed @ hours and the ones assessed @ , @ and @ days after the operation in the control group ( p < @ ) .", "there was the statistically significant difference between the bleeding vas scores of experimental group and control group assessed @ h after the operation ( p < @ ) .", "the hemocoagulase may improve the hemostatic effect of nasopore @ hours after the operation by combined injection with nasopore as nasal cavity packing ." ]
to compare the hemostatic effects of local packing of nasopore combined with hemocoagulase injection and local packing of nasopore combined with saline injection for postoperative management of functional endoscopic sinus surgery by a double-blind , randomized control clinical trial . sixty-eight cases of chronic sinusitis needed functional endoscopic sinus surgery were randomly divided into the experimental group of @ cases and control group of @ cases , respectively . for the experimental group , @ u of hemocoagulase dissolved in @ ml saline was injected into nasopore which was packed into the nasal cavity after operation . for the control group , @ ml of saline was injected . the postoperative bleeding of the two groups were scored by visual analogue scale . there was statistically significant difference between the bleeding vas scores assessed @ hours and the ones assessed @ , @ and @ days after the operation in the control group ( p < @ ) . there was the statistically significant difference between the bleeding vas scores of experimental group and control group assessed @ h after the operation ( p < @ ) . the hemocoagulase may improve the hemostatic effect of nasopore @ hours after the operation by combined injection with nasopore as nasal cavity packing .
25,007,675
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to follow up on a recent report from our lab -lsb- hum psychopharmacol @:@ -@ , @ . -rsb-", "we examined the effects of caffeine on salivary - amylase ( saa ) activity in response to an engaging , non-stressful task in healthy young males ( age @-@ yrs ) who consumed caffeine on a daily basis .", "using a placebo-controlled , double-blind , between-subjects design , @ men received either placebo , @ mg or @ mg of caffeine ( vivarin ) .", "participants then rested for @ minutes , and performed a @-minute computerized air traffic controller-like task that was cognitively engaging but not stressful .", "saliva samples ( assayed for saa and cortisol ) , blood pressure , and heart rate were taken before ( baseline ) and @ minutes after the computerized task .", "systolic and diastolic blood pressure and saa activity increased across the laboratory session ( f 's > @ , p 's < @ ) ; salivary cortisol levels decreased ( f = @ , p < @ ) .", "there were no main effects for caffeine administration on saa , salivary cortisol , or cardiovascular measures , and caffeine did not interact with the task to alter these measures .", "laboratory administered caffeine does not alter saa activity , even when saa activity is stimulated by participating in a cognitively engaging task .", "these data demonstrate that caffeine administration does not affect saa activity , at least in healthy young men who regularly consume caffeine .", "results support recent findings that basal caffeine levels in habitual caffeine users are not associated with basal saa activity and that daily caffeine intake and diurnal saa activity are not related ." ]
to follow up on a recent report from our lab -lsb- hum psychopharmacol @:@ -@ , @ . -rsb- we examined the effects of caffeine on salivary - amylase ( saa ) activity in response to an engaging , non-stressful task in healthy young males ( age @-@ yrs ) who consumed caffeine on a daily basis . using a placebo-controlled , double-blind , between-subjects design , @ men received either placebo , @ mg or @ mg of caffeine ( vivarin ) . participants then rested for @ minutes , and performed a @-minute computerized air traffic controller-like task that was cognitively engaging but not stressful . saliva samples ( assayed for saa and cortisol ) , blood pressure , and heart rate were taken before ( baseline ) and @ minutes after the computerized task . systolic and diastolic blood pressure and saa activity increased across the laboratory session ( f 's > @ , p 's < @ ) ; salivary cortisol levels decreased ( f = @ , p < @ ) . there were no main effects for caffeine administration on saa , salivary cortisol , or cardiovascular measures , and caffeine did not interact with the task to alter these measures . laboratory administered caffeine does not alter saa activity , even when saa activity is stimulated by participating in a cognitively engaging task . these data demonstrate that caffeine administration does not affect saa activity , at least in healthy young men who regularly consume caffeine . results support recent findings that basal caffeine levels in habitual caffeine users are not associated with basal saa activity and that daily caffeine intake and diurnal saa activity are not related .
24,410,993
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the present randomized , two-period , cross-over bioequivalence study compared two soft capsules of etoposide ( test and reference formulations ) , in treating @ advanced lung cancer patients .", "the pharmacokinetic parameters were determined based on the concentrations of etoposide , using hplc with fluorescence detector .", "in each of the two study periods , a single dose of test or reference product was administered .", "the pharmacokinetic parameters assessed included area under the plasma concentration-time curve ( auc ( @-@h ) ) from @ to @ hours , auc ( @-t ) from time zero to infinity , the peak plasma concentration of the drug ( c ( max ) ) , time to achieve c ( max ) , and the elimination half-life .", "comparison of the test and reference products containing etoposide showed that geometric mean ratios ( @ % confidence interval ( ci ) ) of auc ( @-t ) , auc ( @ - ) , and c ( max ) were @ % ( @ - @ % ) , @ % ( @ - @ % ) , and @ % ( @ - @ % ) , respectively .", "both auc and c ( max ) ratio @ % ci of test and reference formulations were within its acceptable range for bioequivalence .", "the values of tmax and t@/@ were not found to have a statistically significant difference between the test and the reference drug ( p > @ ) .", "no adverse events occurred in this bioequivalence study .", "the two etoposide soft capsules ( the test and reference formulations ) were bioequivalent ." ]
the present randomized , two-period , cross-over bioequivalence study compared two soft capsules of etoposide ( test and reference formulations ) , in treating @ advanced lung cancer patients . the pharmacokinetic parameters were determined based on the concentrations of etoposide , using hplc with fluorescence detector . in each of the two study periods , a single dose of test or reference product was administered . the pharmacokinetic parameters assessed included area under the plasma concentration-time curve ( auc ( @-@h ) ) from @ to @ hours , auc ( @-t ) from time zero to infinity , the peak plasma concentration of the drug ( c ( max ) ) , time to achieve c ( max ) , and the elimination half-life . comparison of the test and reference products containing etoposide showed that geometric mean ratios ( @ % confidence interval ( ci ) ) of auc ( @-t ) , auc ( @ - ) , and c ( max ) were @ % ( @ - @ % ) , @ % ( @ - @ % ) , and @ % ( @ - @ % ) , respectively . both auc and c ( max ) ratio @ % ci of test and reference formulations were within its acceptable range for bioequivalence . the values of tmax and t@/@ were not found to have a statistically significant difference between the test and the reference drug ( p > @ ) . no adverse events occurred in this bioequivalence study . the two etoposide soft capsules ( the test and reference formulations ) were bioequivalent .
25,828,637
[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "low-dose acetylsalicylic acid ( asa ; aspirin ) for secondary prevention reduces cardiovascular disease mortality risk .", "asa acetylates cyclooxygenase in the portal circulation and is rapidly ( half-life , @ min ) hydrolyzed .", "certain patients with cardiovascular disease may exhibit high on-therapy platelet reactivity as a result of high platelet turnover , a process whereby platelets are produced and are active beyond the duration of antiplatelet coverage provided by once-daily immediate-release ( ir ) asa .", "a once-daily , extended-release ( er ) asa formulation using er microcapsule technology was developed to release asa over the @-h dosing interval and reduce maximal plasma concentrations to spare peripheral endogenous endothelial prostacyclin production .", "healthy adults ( n = @ ) were randomized in a crossover study to receive two different er-asa single doses ( up to @ mg ) and two different ir-asa single doses ( up to @ mg ) in four periods , each separated by @ days .", "pharmacodynamics was assessed by measuring serum thromboxane b@ ( txb@ ) , urine @-dehydro-txb@ , and arachidonic acid-induced platelet aggregation .", "pharmacokinetics was determined for asa and salicylic acid ( sa ) .", "both formulations produced dose-dependent inhibition on all pharmacodynamic parameters .", "marked inhibition of txb@ and @-dehydro-txb@ was maintained over the @-h dosing interval after a dose of @ mg er-asa or @ mg ir-asa .", "the dose required to achieve @ % of maximum txb@ inhibition with er-asa was @ mg versus @ mg for ir-asa , for a similar maximum pharmacodynamic effect ( @ % txb@ inhibition ) .", "this suggests that an approximately twofold greater er-asa dose ( @ mg ) is necessary to obtain the same response as that of ir-asa @ mg .", "peak asa concentrations were lower and tmax was longer with er-asa versus ir-asa .", "administration of ir-asa resulted in a dose-normalized mean cmax of asa that was approximately sixfold higher than that for er-asa and a cmax of sa approximately two - to threefold higher than that for er-asa .", "both asa formulations showed dose-dependent antiplatelet activity .", "compared with the ir-asa , er-asa released active drug more slowly , resulting in prolonged absorption and lower systemic drug concentrations , which is expected for an er ( @-h ) formulation ." ]
low-dose acetylsalicylic acid ( asa ; aspirin ) for secondary prevention reduces cardiovascular disease mortality risk . asa acetylates cyclooxygenase in the portal circulation and is rapidly ( half-life , @ min ) hydrolyzed . certain patients with cardiovascular disease may exhibit high on-therapy platelet reactivity as a result of high platelet turnover , a process whereby platelets are produced and are active beyond the duration of antiplatelet coverage provided by once-daily immediate-release ( ir ) asa . a once-daily , extended-release ( er ) asa formulation using er microcapsule technology was developed to release asa over the @-h dosing interval and reduce maximal plasma concentrations to spare peripheral endogenous endothelial prostacyclin production . healthy adults ( n = @ ) were randomized in a crossover study to receive two different er-asa single doses ( up to @ mg ) and two different ir-asa single doses ( up to @ mg ) in four periods , each separated by @ days . pharmacodynamics was assessed by measuring serum thromboxane b@ ( txb@ ) , urine @-dehydro-txb@ , and arachidonic acid-induced platelet aggregation . pharmacokinetics was determined for asa and salicylic acid ( sa ) . both formulations produced dose-dependent inhibition on all pharmacodynamic parameters . marked inhibition of txb@ and @-dehydro-txb@ was maintained over the @-h dosing interval after a dose of @ mg er-asa or @ mg ir-asa . the dose required to achieve @ % of maximum txb@ inhibition with er-asa was @ mg versus @ mg for ir-asa , for a similar maximum pharmacodynamic effect ( @ % txb@ inhibition ) . this suggests that an approximately twofold greater er-asa dose ( @ mg ) is necessary to obtain the same response as that of ir-asa @ mg . peak asa concentrations were lower and tmax was longer with er-asa versus ir-asa . administration of ir-asa resulted in a dose-normalized mean cmax of asa that was approximately sixfold higher than that for er-asa and a cmax of sa approximately two - to threefold higher than that for er-asa . both asa formulations showed dose-dependent antiplatelet activity . compared with the ir-asa , er-asa released active drug more slowly , resulting in prolonged absorption and lower systemic drug concentrations , which is expected for an er ( @-h ) formulation .
25,998,572
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "in our hospital , lumbar epidural analgesia had been used for postoperative analgesia following vaginal total hysterectomy ( vth ) .", "but some patients experienced severe abdominal pain or numbness of the legs .", "therefore we planned a randomized prospective study to compare lower thoracic epidural analgesia and lumbar epidural analgesia following vth .", "fifty patients were allocated to two groups : those who received lower thoracic epidural analgesia ( t group ) and the other who received lumbar epidural analgesia ( l group ) .", "both groupsreceived the same continuous epidural analgesia using fentanyl and ropivacaine after the operation .", "the t group required significantly lower frequency of analgesic agents compared with that of the l group ( @ times vs. @ times , p < @ ) .", "fewer patients in the t group had felt numbness in their legs compared to the l group ( @ % vs. @ % , p < @ ) .", "lower thoracic epidural analgesia is more effective to provide postoperative analgesic effect following vth compared with lumbar epidural analgesia ." ]
in our hospital , lumbar epidural analgesia had been used for postoperative analgesia following vaginal total hysterectomy ( vth ) . but some patients experienced severe abdominal pain or numbness of the legs . therefore we planned a randomized prospective study to compare lower thoracic epidural analgesia and lumbar epidural analgesia following vth . fifty patients were allocated to two groups : those who received lower thoracic epidural analgesia ( t group ) and the other who received lumbar epidural analgesia ( l group ) . both groupsreceived the same continuous epidural analgesia using fentanyl and ropivacaine after the operation . the t group required significantly lower frequency of analgesic agents compared with that of the l group ( @ times vs. @ times , p < @ ) . fewer patients in the t group had felt numbness in their legs compared to the l group ( @ % vs. @ % , p < @ ) . lower thoracic epidural analgesia is more effective to provide postoperative analgesic effect following vth compared with lumbar epidural analgesia .
25,693,331
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to evaluate changes in corneal epithelial and stromal thickness after corneal collagen cross-linking ( cxl ) in eyes with keratoconus and postoperative corneal ectasia using spectral-domain optical coherence tomography ( sd-oct ) .", "anterior segment sd-oct ( rtvue-@ ; optovue , inc. , fremont , ca ) was used to compare regional corneal epithelial and stromal thickness in eyes with keratoconus and ectasia before cxl and @ and @ months after cxl .", "the anterior surface of the cornea , epithelium-bowman 's layer interface , and posterior reflective surface were used as anatomical landmarks to measure epithelial and stromal thickness , respectively .", "regional thickness was assessed centrally and at @ points @ mm apart across the central @ mm of the corneal vertex in the horizontal and vertical meridians .", "thirty-one eyes from @ patients were evaluated , including @ eyes ( @ patients ) with keratoconus and @ eyes ( @ patients ) with ectasia .", "preoperatively , a highly irregular epithelial thickness profile and distribution was observed in both groups .", "after cxl , epithelial thickness was significantly thinner @ and @ mm below and @ mm above the corneal apex ( @ @ m ; range : @ to @ m ) , and @ and @ mm nasal and @ mm temporal to the corneal apex ( @ @ m ; range : @ to @ m ) compared to preoperative values ( p < @ for all measurements ) .", "epithelial thickness standard deviations were significantly lower ( by @ to @ m ) @ months after cxl , compared to ranges before cxl in both the vertical and horizontal meridians for keratoconus and ectasia ( p = @ ) .", "no significant differences were found between epithelial remodeling in keratoconus and corneal ectasia ( p = @ ) .", "no significant or consistent stromal changes were found for either group .", "significant epithelial remodeling occurs after cxl in eyes with keratoconus and corneal ectasia , creating a similar , more regularized thickness profile in all meridians in the early postoperative period .", "this pattern of remodeling may facilitate interpretation of corneal curvature and thickness changes after cxl and may be related to visual acuity after cxl ." ]
to evaluate changes in corneal epithelial and stromal thickness after corneal collagen cross-linking ( cxl ) in eyes with keratoconus and postoperative corneal ectasia using spectral-domain optical coherence tomography ( sd-oct ) . anterior segment sd-oct ( rtvue-@ ; optovue , inc. , fremont , ca ) was used to compare regional corneal epithelial and stromal thickness in eyes with keratoconus and ectasia before cxl and @ and @ months after cxl . the anterior surface of the cornea , epithelium-bowman 's layer interface , and posterior reflective surface were used as anatomical landmarks to measure epithelial and stromal thickness , respectively . regional thickness was assessed centrally and at @ points @ mm apart across the central @ mm of the corneal vertex in the horizontal and vertical meridians . thirty-one eyes from @ patients were evaluated , including @ eyes ( @ patients ) with keratoconus and @ eyes ( @ patients ) with ectasia . preoperatively , a highly irregular epithelial thickness profile and distribution was observed in both groups . after cxl , epithelial thickness was significantly thinner @ and @ mm below and @ mm above the corneal apex ( @ @ m ; range : @ to @ m ) , and @ and @ mm nasal and @ mm temporal to the corneal apex ( @ @ m ; range : @ to @ m ) compared to preoperative values ( p < @ for all measurements ) . epithelial thickness standard deviations were significantly lower ( by @ to @ m ) @ months after cxl , compared to ranges before cxl in both the vertical and horizontal meridians for keratoconus and ectasia ( p = @ ) . no significant differences were found between epithelial remodeling in keratoconus and corneal ectasia ( p = @ ) . no significant or consistent stromal changes were found for either group . significant epithelial remodeling occurs after cxl in eyes with keratoconus and corneal ectasia , creating a similar , more regularized thickness profile in all meridians in the early postoperative period . this pattern of remodeling may facilitate interpretation of corneal curvature and thickness changes after cxl and may be related to visual acuity after cxl .
24,763,478
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "second-generation everolimus-eluting stents ( ees ) and third generation biolimus-eluting stents ( bes ) have been shown to be superior to first-generation paclitaxel-eluting stents ( pes ) and second-generation sirolimus-eluting stents ( ses ) .", "however , neointimal proliferation and very late stent thrombosis is still an unresolved issue of drug-eluting stent ( des ) implantation overall .", "the absorb ( abbott vascular , abbott park , il , usa ) is the first ce approved des with a bioresorbable vascular scaffold ( bvs ) thought to reduce long-term complication rates .", "the everbio ii trial was set up to compare the bvs safety and efficacy with both ees and bes in all patients viable for inclusion .", "the everbio ii trial is a single-center , assessor-blinded , randomized trial .", "the study population consists of all patients aged@ years old undergoing percutaneous coronary intervention .", "exclusion criterion is where the lesion can not be treated with bvs ( reference vessel diameter > @ mm ) .", "a total of @ patients will be enrolled and randomly assigned into @ groups of @ with either bvs , ees or bes implantation .", "all patients will undergo a follow-up angiography study at @ months .", "clinical follow-up for up to @ years will be conducted by telephone .", "the primary endpoint is in-segment late lumen loss at @ months measured by quantitative coronary angiography .", "secondary endpoints are patient-oriented major adverse cardiac event ( mace ) ( death , myocardial infarction and target-vessel revascularization ) , device-oriented mace ( cardiac death , myocardial infarction and target-lesion revascularization ) , stent thrombosis according to arc and binary restenosis at follow-up @ months angiography .", "everbio ii is an independent , randomized study , aiming to compare the clinical efficacy , angiographic outcomes and safety of bvs , ees and bes in all comer patients .", "the trial listed in clinicaltrials.gov as nct@ ." ]
second-generation everolimus-eluting stents ( ees ) and third generation biolimus-eluting stents ( bes ) have been shown to be superior to first-generation paclitaxel-eluting stents ( pes ) and second-generation sirolimus-eluting stents ( ses ) . however , neointimal proliferation and very late stent thrombosis is still an unresolved issue of drug-eluting stent ( des ) implantation overall . the absorb ( abbott vascular , abbott park , il , usa ) is the first ce approved des with a bioresorbable vascular scaffold ( bvs ) thought to reduce long-term complication rates . the everbio ii trial was set up to compare the bvs safety and efficacy with both ees and bes in all patients viable for inclusion . the everbio ii trial is a single-center , assessor-blinded , randomized trial . the study population consists of all patients aged@ years old undergoing percutaneous coronary intervention . exclusion criterion is where the lesion can not be treated with bvs ( reference vessel diameter > @ mm ) . a total of @ patients will be enrolled and randomly assigned into @ groups of @ with either bvs , ees or bes implantation . all patients will undergo a follow-up angiography study at @ months . clinical follow-up for up to @ years will be conducted by telephone . the primary endpoint is in-segment late lumen loss at @ months measured by quantitative coronary angiography . secondary endpoints are patient-oriented major adverse cardiac event ( mace ) ( death , myocardial infarction and target-vessel revascularization ) , device-oriented mace ( cardiac death , myocardial infarction and target-lesion revascularization ) , stent thrombosis according to arc and binary restenosis at follow-up @ months angiography . everbio ii is an independent , randomized study , aiming to compare the clinical efficacy , angiographic outcomes and safety of bvs , ees and bes in all comer patients . the trial listed in clinicaltrials.gov as nct@ .
24,398,143
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "BACKGROUND" ]
[ "to provide broader protection against pneumococcal disease , new vaccines containing conserved streptococcus pneumoniae proteins are being developed .", "this study assessed the safety , reactogenicity and immunogenicity of four formulations containing pneumococcal proteins pneumolysin toxoid ( dply ) and histidine triad protein ( phtd ) in toddlers .", "in this phase ii , multicenter , observer-blind study ( www.clinicaltrials.gov : nct@ ) conducted in the czech republic , toddlers ( @-@ months ) were randomized ( @:@:@:@:@ ) to receive one of four investigational vaccine formulations ( @ or @g each of dply and phtd , alone or in combination with polysaccharide conjugates from the pneumococcal non-typeable haemophilus influenzae protein-d conjugate vaccine -lsb- phid-cv -rsb- ) , or the licensed phid-cv , in a @-dose primary series plus booster at study months @ , @ and @ .", "solicited local and general symptoms were recorded within seven days post-vaccination , unsolicited symptoms within @ days post-vaccination , and serious adverse events ( saes ) during the entire study period .", "antibody concentrations against the vaccine components were measured pre-vaccination , one month post-dose @ , pre - and one month post-booster .", "@ toddlers were enrolled and vaccinated .", "percentages of solicited local and general symptoms following the different investigational formulations were generally within the same ranges as for phid-cv .", "after each dose , grade @ fever ( > @ c , rectal measurement ) was reported for maximum one toddler in each group with no differences between investigational formulations and phid-cv during primary vaccination .", "@ saes were reported for @ toddlers , with distribution balanced between all groups except the group receiving @ g dply/phtd with phid-cv-conjugates ( no saes reported ) .", "none of the saes were considered to be vaccine-related .", "for all pneumococcal protein-containing formulations , anti-phtd and anti-ply antibody geometric mean concentrations increased from pre-vaccination to post-dose @ and from pre - to post-booster vaccination .", "all investigational vaccine formulations were well-tolerated and immunogenic when administered to toddlers as a @-dose primary vaccination followed by a booster dose ." ]
to provide broader protection against pneumococcal disease , new vaccines containing conserved streptococcus pneumoniae proteins are being developed . this study assessed the safety , reactogenicity and immunogenicity of four formulations containing pneumococcal proteins pneumolysin toxoid ( dply ) and histidine triad protein ( phtd ) in toddlers . in this phase ii , multicenter , observer-blind study ( www.clinicaltrials.gov : nct@ ) conducted in the czech republic , toddlers ( @-@ months ) were randomized ( @:@:@:@:@ ) to receive one of four investigational vaccine formulations ( @ or @g each of dply and phtd , alone or in combination with polysaccharide conjugates from the pneumococcal non-typeable haemophilus influenzae protein-d conjugate vaccine -lsb- phid-cv -rsb- ) , or the licensed phid-cv , in a @-dose primary series plus booster at study months @ , @ and @ . solicited local and general symptoms were recorded within seven days post-vaccination , unsolicited symptoms within @ days post-vaccination , and serious adverse events ( saes ) during the entire study period . antibody concentrations against the vaccine components were measured pre-vaccination , one month post-dose @ , pre - and one month post-booster . @ toddlers were enrolled and vaccinated . percentages of solicited local and general symptoms following the different investigational formulations were generally within the same ranges as for phid-cv . after each dose , grade @ fever ( > @ c , rectal measurement ) was reported for maximum one toddler in each group with no differences between investigational formulations and phid-cv during primary vaccination . @ saes were reported for @ toddlers , with distribution balanced between all groups except the group receiving @ g dply/phtd with phid-cv-conjugates ( no saes reported ) . none of the saes were considered to be vaccine-related . for all pneumococcal protein-containing formulations , anti-phtd and anti-ply antibody geometric mean concentrations increased from pre-vaccination to post-dose @ and from pre - to post-booster vaccination . all investigational vaccine formulations were well-tolerated and immunogenic when administered to toddlers as a @-dose primary vaccination followed by a booster dose .
24,699,466
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the purpose of this study was to evaluate a personalized protocol with diluted contrast material ( cm ) for coronary computed tomography angiography ( cta ) .", "one hundred patients with suspected coronary artery disease underwent retrospective electrocardiogram-gated coronary cta on a @-slice multidetector-row ct scanner .", "in the diluted cm protocol ( n = @ ) , the optimal scan timing and cm dilution rate were determined by the timing bolus scan , with @ % cm dilution ( @ml/s during @s ) being considered suitable to achieve the target arterial attenuation of @ hounsfield units ( hu ) .", "in the body weight ( bw ) - adjusted protocol ( n = @ , @mg iodine/kg ) , only the optimal scan timing was determined by the timing bolus scan .", "the injection rate and volume in the timing bolus scan and real scan were identical between the @ protocols .", "we compared the means and variations in coronary attenuation between the @ protocols .", "coronary attenuation ( meansd ) in the diluted cm and bw-adjusted protocols was @ hu and @ hu , respectively .", "the diluted cm protocol provided significantly higher coronary attenuation and lower variance than did the bw-adjusted protocol ( p < @ , in each ) .", "the diluted cm protocol facilitates more uniform attenuation on coronary cta in comparison with the bw-adjusted protocol ." ]
the purpose of this study was to evaluate a personalized protocol with diluted contrast material ( cm ) for coronary computed tomography angiography ( cta ) . one hundred patients with suspected coronary artery disease underwent retrospective electrocardiogram-gated coronary cta on a @-slice multidetector-row ct scanner . in the diluted cm protocol ( n = @ ) , the optimal scan timing and cm dilution rate were determined by the timing bolus scan , with @ % cm dilution ( @ml/s during @s ) being considered suitable to achieve the target arterial attenuation of @ hounsfield units ( hu ) . in the body weight ( bw ) - adjusted protocol ( n = @ , @mg iodine/kg ) , only the optimal scan timing was determined by the timing bolus scan . the injection rate and volume in the timing bolus scan and real scan were identical between the @ protocols . we compared the means and variations in coronary attenuation between the @ protocols . coronary attenuation ( meansd ) in the diluted cm and bw-adjusted protocols was @ hu and @ hu , respectively . the diluted cm protocol provided significantly higher coronary attenuation and lower variance than did the bw-adjusted protocol ( p < @ , in each ) . the diluted cm protocol facilitates more uniform attenuation on coronary cta in comparison with the bw-adjusted protocol .
24,366,100
[ "BACKGROUND", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "technological innovations in dental materials have been fueled by the desire of patients to improve the esthetics of their teeth .", "this emphasis on esthetics has led dentists to seek resources that respect the standards established by society , but without compromising the integrity of the teeth .", "the aim of the proposed controlled clinical trial will be to assess colorimetric changes and increased dental sensitivity in adolescent patients submitted to tooth whitening with @ % and @ % hydrogen peroxide using home kits with whitening strips .", "adolescents aged @ to @ years will be allocated to different groups based on treatment ( n = @ per group ) : ( @ ) placebo ; ( @ ) @ % hydrogen peroxide ( white class with calcium , fgm ) ; ( @ ) @ % hydrogen peroxide ( white class with calcium , fgm ) ; and ( @ ) @ % hydrogen peroxide ( oral b @d white , oral-b ) .", "after the whitening procedures , the participants will be evaluated using a visual analog scale for tooth sensitivity and digital spectrophotometry to measure changes in color .", "descriptive analysis of the data will be performed .", "either the chi-squared test or fisher 's exact test will be used for the determination of associations among the categorical variables .", "student 's t-test and analysis of variance will be used to compare mean colorimetric data .", "pearson 's correlation coefficients will be calculated to determine the strength of correlations among the continuous variables .", "this randomized trial will provide an opportunity to evaluate products such as whitening strips in comparison to other self-administered methods , especially in adolescents .", "the protocol for this study was submitted to clinical trials in november @ with registration number nct@ ." ]
technological innovations in dental materials have been fueled by the desire of patients to improve the esthetics of their teeth . this emphasis on esthetics has led dentists to seek resources that respect the standards established by society , but without compromising the integrity of the teeth . the aim of the proposed controlled clinical trial will be to assess colorimetric changes and increased dental sensitivity in adolescent patients submitted to tooth whitening with @ % and @ % hydrogen peroxide using home kits with whitening strips . adolescents aged @ to @ years will be allocated to different groups based on treatment ( n = @ per group ) : ( @ ) placebo ; ( @ ) @ % hydrogen peroxide ( white class with calcium , fgm ) ; ( @ ) @ % hydrogen peroxide ( white class with calcium , fgm ) ; and ( @ ) @ % hydrogen peroxide ( oral b @d white , oral-b ) . after the whitening procedures , the participants will be evaluated using a visual analog scale for tooth sensitivity and digital spectrophotometry to measure changes in color . descriptive analysis of the data will be performed . either the chi-squared test or fisher 's exact test will be used for the determination of associations among the categorical variables . student 's t-test and analysis of variance will be used to compare mean colorimetric data . pearson 's correlation coefficients will be calculated to determine the strength of correlations among the continuous variables . this randomized trial will provide an opportunity to evaluate products such as whitening strips in comparison to other self-administered methods , especially in adolescents . the protocol for this study was submitted to clinical trials in november @ with registration number nct@ .
25,315,893
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "BACKGROUND" ]
[ "hypertension treatments include sodium restriction , pharmacological management , and lifestyle modifications .", "although many cases of hypertension can be controlled by medication , individuals may experience side effects or incur out-of-pocket expenses , and some may not comply with the treatment regimen .", "although some previous studies have shown a favorable effect for qigong on hypertension , well-designed , rigorous trials evaluating the effect of qigong on hypertension are scarce .", "this study aimed to evaluate the effect of qigong on prehypertension and mild hypertension and to calculate a sample size for a subsequent randomized , clinical trial ( rct ) .", "participants were randomized to a qigong group or an untreated control group .", "this study was conducted at the oriental medical center of dongeui university , in the republic of korea .", "participants were individuals between the ages of @ and @ y with systolic blood pressure ( sbp ) between @ and @ mm hg and/or diastolic blood pressure ( dbp ) between @ and @ mm hg .", "the qigong group attended qigong classes @ / wk and performed qigong at home at least @ / wk .", "participants in the control group did not receive any intervention for hypertension .", "outcome measures for this study were ( @ ) changes in blood pressure ( bp ) ; ( @ ) quality of life ( qol ) using @ surveys : the medical outcomes study ( mos ) @-item short form ( sf-@ ) ( korean version ) and the measure yourself medical outcome profile @ ( mymop@ ) ; and ( @ ) hormone levels .", "of @ participants , @ were randomly assigned to the qigong group , and @ were assigned to the control group .", "after @ wk , significant differences were observed between the qigong and the control groups regarding changes in sbp ( p = @ ) and dbp ( p = @ ) .", "among the categories of the mymop@ questionnaire , only wellbeing was significantly different between the @ groups ( p = @ ) .", "the qigong group showed a significantly greater improvement in the physical component score of the sf-@ compared with the control group ( p = @ ) .", "regarding changes in hormone levels , there was no significant difference between the qigong and the control groups .", "this pilot study demonstrates that regarding sample size , a rct evaluating the effect of qigong on hypertension should include @ participants based on dbp and @ participants based on sbp in each group , thus allowing for a loss to follow-up rate of @ % .", "the results indicate that qigong may be an effective intervention in reducing bp in prehypertension and mild hypertension .", "further studies should include an appropriate sample size and methodology to determine the mechanism of qigong on bp ." ]
hypertension treatments include sodium restriction , pharmacological management , and lifestyle modifications . although many cases of hypertension can be controlled by medication , individuals may experience side effects or incur out-of-pocket expenses , and some may not comply with the treatment regimen . although some previous studies have shown a favorable effect for qigong on hypertension , well-designed , rigorous trials evaluating the effect of qigong on hypertension are scarce . this study aimed to evaluate the effect of qigong on prehypertension and mild hypertension and to calculate a sample size for a subsequent randomized , clinical trial ( rct ) . participants were randomized to a qigong group or an untreated control group . this study was conducted at the oriental medical center of dongeui university , in the republic of korea . participants were individuals between the ages of @ and @ y with systolic blood pressure ( sbp ) between @ and @ mm hg and/or diastolic blood pressure ( dbp ) between @ and @ mm hg . the qigong group attended qigong classes @ / wk and performed qigong at home at least @ / wk . participants in the control group did not receive any intervention for hypertension . outcome measures for this study were ( @ ) changes in blood pressure ( bp ) ; ( @ ) quality of life ( qol ) using @ surveys : the medical outcomes study ( mos ) @-item short form ( sf-@ ) ( korean version ) and the measure yourself medical outcome profile @ ( mymop@ ) ; and ( @ ) hormone levels . of @ participants , @ were randomly assigned to the qigong group , and @ were assigned to the control group . after @ wk , significant differences were observed between the qigong and the control groups regarding changes in sbp ( p = @ ) and dbp ( p = @ ) . among the categories of the mymop@ questionnaire , only wellbeing was significantly different between the @ groups ( p = @ ) . the qigong group showed a significantly greater improvement in the physical component score of the sf-@ compared with the control group ( p = @ ) . regarding changes in hormone levels , there was no significant difference between the qigong and the control groups . this pilot study demonstrates that regarding sample size , a rct evaluating the effect of qigong on hypertension should include @ participants based on dbp and @ participants based on sbp in each group , thus allowing for a loss to follow-up rate of @ % . the results indicate that qigong may be an effective intervention in reducing bp in prehypertension and mild hypertension . further studies should include an appropriate sample size and methodology to determine the mechanism of qigong on bp .
25,141,360
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the metabolic variability and response to acute systematic hypoxia have been characterized by the high resolution of liquid chromatography/time-of-flight/mass spectrometry ( lc-tof/ms ) in this study .", "specifically , we compared the urinary metabolic profiles of six healthy sedentary men under normoxia ( @ % o@ ) with acute systematic hypoxic conditions of @ % ( equivalent to about @ m in altitude ) and @ % o@ ( equivalent to about @ m in altitude ) for @ h in a normobaric hypoxia chamber .", "a clear separation of dose-dependent responses was visualized by partial least squares discriminant analysis ( pls-da ) between normoxic and hypoxic conditions .", "over one thousand features were found in this study , about @ % of which showed significant change from hypoxia treatment and @ metabolites were identified ; however , there is great variability in metabolite concentrations among the @ subjects , which reflects the diversity of human systems .", "within the variability , we found that @-methyladenosine and @-methylthioadenosine are conspicuously upregulated ; on the other hand , @-inodoleacetic acid and l-glutamic acid were downregulated .", "the increase in purine metabolic products ( uric acid , xanthine , and hypoxathine ) results from hypoxia ; this increase can be used as a marker for the hypoxic condition .", "@-methyladenosine was also highly upregulated from mh to sh and may be a very sensitive biomarker that reflects cellular hypoxia , due to its potential connection to hif-@ .", "the increase of free carnitine and acetyl carnitines , on the other hand , signals a change in the pathway of energy , or lipid , metabolism ." ]
the metabolic variability and response to acute systematic hypoxia have been characterized by the high resolution of liquid chromatography/time-of-flight/mass spectrometry ( lc-tof/ms ) in this study . specifically , we compared the urinary metabolic profiles of six healthy sedentary men under normoxia ( @ % o@ ) with acute systematic hypoxic conditions of @ % ( equivalent to about @ m in altitude ) and @ % o@ ( equivalent to about @ m in altitude ) for @ h in a normobaric hypoxia chamber . a clear separation of dose-dependent responses was visualized by partial least squares discriminant analysis ( pls-da ) between normoxic and hypoxic conditions . over one thousand features were found in this study , about @ % of which showed significant change from hypoxia treatment and @ metabolites were identified ; however , there is great variability in metabolite concentrations among the @ subjects , which reflects the diversity of human systems . within the variability , we found that @-methyladenosine and @-methylthioadenosine are conspicuously upregulated ; on the other hand , @-inodoleacetic acid and l-glutamic acid were downregulated . the increase in purine metabolic products ( uric acid , xanthine , and hypoxathine ) results from hypoxia ; this increase can be used as a marker for the hypoxic condition . @-methyladenosine was also highly upregulated from mh to sh and may be a very sensitive biomarker that reflects cellular hypoxia , due to its potential connection to hif-@ . the increase of free carnitine and acetyl carnitines , on the other hand , signals a change in the pathway of energy , or lipid , metabolism .
24,666,029
[ "OBJECTIVE", "OBJECTIVE", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "there is still no gold standard technique for graft fixation during anterior cruciate ligament reconstruction .", "we compared the functional outcomes of patients receiving either toggleloc with ziploop technology or translig transverse crosspin device for femoral graft fixation .", "a total of @ patients were randomly allocated into two groups to receive either translig ( ) transverse crosspin ( translig group @ : n = @ , mean age @ years , age @-@years ) or toggleloc with ziploop technology ( toggleloc group : n = @ , mean age @ , age @-@years ) for femoral graft fixation .", "early and @-year assessment was made with lysholm knee scale , international knee documentation committee scoring , tegner activity level scale , kt-@ arthrometer and pivot shift test .", "preoperative vs. postoperative functional parameters showed significant improvement in both groups .", "two groups were similar in terms of lysholm knee scale , ikdc and tegner activity scores ( p > @ ) .", "the kt-@ arthrometer revealed slightly less anterior sliding in translig group than that in toggleloc group ( p > @ ) .", "toggleloc technique allowed a radiographically more horizontal placement of the graft than translig technique .", "two distinct techniques used in this study are likely to be suitable for femoral graft fixation during anterior cruciate ligament reconstruction with the femoral tunnel being created via anteromedial approach ." ]
there is still no gold standard technique for graft fixation during anterior cruciate ligament reconstruction . we compared the functional outcomes of patients receiving either toggleloc with ziploop technology or translig transverse crosspin device for femoral graft fixation . a total of @ patients were randomly allocated into two groups to receive either translig ( ) transverse crosspin ( translig group @ : n = @ , mean age @ years , age @-@years ) or toggleloc with ziploop technology ( toggleloc group : n = @ , mean age @ , age @-@years ) for femoral graft fixation . early and @-year assessment was made with lysholm knee scale , international knee documentation committee scoring , tegner activity level scale , kt-@ arthrometer and pivot shift test . preoperative vs. postoperative functional parameters showed significant improvement in both groups . two groups were similar in terms of lysholm knee scale , ikdc and tegner activity scores ( p > @ ) . the kt-@ arthrometer revealed slightly less anterior sliding in translig group than that in toggleloc group ( p > @ ) . toggleloc technique allowed a radiographically more horizontal placement of the graft than translig technique . two distinct techniques used in this study are likely to be suitable for femoral graft fixation during anterior cruciate ligament reconstruction with the femoral tunnel being created via anteromedial approach .
25,047,162
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "antibody-mediated rejection ( amr ) is a severe form of rejection , mediated primarily by antibody-dependent complement ( c ) activation .", "c@ inhibitor ( c@-inh , berinert ) inhibits the classical and lectin pathways of c activation .", "we performed a randomized , placebo-controlled study using c@-inh in highly sensitized renal transplant recipients for prevention of amr .", "twenty highly sensitized patients desensitized with ivig + rituximabplasma exchange were enrolled and randomized @:@ to receive plasma-derived human c@-inh ( @ iu/kg/dose ) versus placebo intraoperatively , then twice weekly for @ doses .", "renal function , adverse events ( aes ) / serious aes , c@ , c@ , and c@-inh levels were monitored and c@q + hla antibodies were also blindly assessed .", "one patient in the c@-inh group versus @ patients in the placebo group developed serious aes , but none were related to study drug .", "delayed graft function developed in @ c@-inh subject and @ in the placebo .", "the c@-inh trough levels increased with c@-inh treatment .", "c@ and c@ levels also increased significantly in the c@-inh group compared to placebo .", "no c@-inh patient developed amr during the study .", "two patients developed amr after the study .", "three placebo patients developed amr , one during the study .", "c@q + donor specific antibodies were reduced in @ c@-inh treated patients tested , while immunoglobulin g dsa levels showed decreased binding for both groups .", "the c@-inh appears safe in the posttransplant period .", "the c@-inh treatment may reduce ischemia-reperfusion injury .", "the c@-inh also resulted in significant elevations of c@-inh levels , c@ , c@ , and reduced c@q + hla antibodies .", "taken together , the combination of antibody reduction and c@-inh may prove useful in prevention of amr .", "further controlled studies are warranted ." ]
antibody-mediated rejection ( amr ) is a severe form of rejection , mediated primarily by antibody-dependent complement ( c ) activation . c@ inhibitor ( c@-inh , berinert ) inhibits the classical and lectin pathways of c activation . we performed a randomized , placebo-controlled study using c@-inh in highly sensitized renal transplant recipients for prevention of amr . twenty highly sensitized patients desensitized with ivig + rituximabplasma exchange were enrolled and randomized @:@ to receive plasma-derived human c@-inh ( @ iu/kg/dose ) versus placebo intraoperatively , then twice weekly for @ doses . renal function , adverse events ( aes ) / serious aes , c@ , c@ , and c@-inh levels were monitored and c@q + hla antibodies were also blindly assessed . one patient in the c@-inh group versus @ patients in the placebo group developed serious aes , but none were related to study drug . delayed graft function developed in @ c@-inh subject and @ in the placebo . the c@-inh trough levels increased with c@-inh treatment . c@ and c@ levels also increased significantly in the c@-inh group compared to placebo . no c@-inh patient developed amr during the study . two patients developed amr after the study . three placebo patients developed amr , one during the study . c@q + donor specific antibodies were reduced in @ c@-inh treated patients tested , while immunoglobulin g dsa levels showed decreased binding for both groups . the c@-inh appears safe in the posttransplant period . the c@-inh treatment may reduce ischemia-reperfusion injury . the c@-inh also resulted in significant elevations of c@-inh levels , c@ , c@ , and reduced c@q + hla antibodies . taken together , the combination of antibody reduction and c@-inh may prove useful in prevention of amr . further controlled studies are warranted .
25,606,785
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "invasive candidiasis in premature infants causes death and neurodevelopmental impairment .", "fluconazole prophylaxis reduces candidiasis , but its effect on mortality and the safety of fluconazole are unknown .", "to evaluate the efficacy and safety of fluconazole in preventing death or invasive candidiasis in extremely low-birth-weight infants .", "this study was a randomized , blinded , placebo-controlled trial of fluconazole in premature infants .", "infants weighing less than @ g at birth ( n = @ ) from @ neonatal intensive care units ( nicus ) in the united states were randomly assigned to receive either fluconazole or placebo twice weekly for @ days .", "surviving infants were evaluated at @ to @ months corrected age for neurodevelopmental outcomes .", "the study was conducted between november @ and february @ .", "fluconazole ( @ mg/kg of body weight ) or placebo .", "the primary end point was a composite of death or definite or probable invasive candidiasis prior to study day @ ( @ week after completion of study drug ) .", "secondary and safety outcomes included invasive candidiasis , liver function , bacterial infection , length of stay , intracranial hemorrhage , periventricular leukomalacia , chronic lung disease , patent ductus arteriosus requiring surgery , retinopathy of prematurity requiring surgery , necrotizing enterocolitis , spontaneous intestinal perforation , and neurodevelopmental outcomes-defined as a bayley-iii cognition composite score of less than @ , blindness , deafness , or cerebral palsy at @ to @ months corrected age .", "among infants receiving fluconazole , the composite primary end point of death or invasive candidiasis was @ % ( @ % ci , @ % -@ % ) vs @ % in the placebo group ( @ % ci , @ % -@ % ; odds ratio , @ -lsb- @ % ci , @-@ @ -rsb- ; p = @ ; treatment difference , -@ % -lsb- @ % ci , -@ % to @ % -rsb- ) .", "invasive candidiasis occurred less frequently in the fluconazole group ( @ % -lsb- @ % ci , @ % -@ % -rsb- ) vs the placebo group ( @ % -lsb- @ % ci , @ % -@ % -rsb- ; p = @ ; treatment difference , -@ % -lsb- @ % ci , -@ % to -@ % -rsb- ) .", "the cumulative incidences of other secondary outcomes were not statistically different between groups .", "neurodevelopmental impairment did not differ between the groups ( fluconazole , @ % -lsb- @ % ci , @ % -@ % -rsb- vs placebo , @ % -lsb- @ % ci , @ % -@ % -rsb- ; p = @ ; treatment difference , @ % -lsb- @ % ci , -@ % to @ % -rsb- ) .", "among infants with a birth weight of less than @ g , @ days of fluconazole prophylaxis compared with placebo did not result in a lower incidence of the composite of death or invasive candidiasis .", "these findings do not support the universal use of prophylactic fluconazole in extremely low-birth-weight infants .", "clinicaltrials.gov identifier : nct@ ." ]
invasive candidiasis in premature infants causes death and neurodevelopmental impairment . fluconazole prophylaxis reduces candidiasis , but its effect on mortality and the safety of fluconazole are unknown . to evaluate the efficacy and safety of fluconazole in preventing death or invasive candidiasis in extremely low-birth-weight infants . this study was a randomized , blinded , placebo-controlled trial of fluconazole in premature infants . infants weighing less than @ g at birth ( n = @ ) from @ neonatal intensive care units ( nicus ) in the united states were randomly assigned to receive either fluconazole or placebo twice weekly for @ days . surviving infants were evaluated at @ to @ months corrected age for neurodevelopmental outcomes . the study was conducted between november @ and february @ . fluconazole ( @ mg/kg of body weight ) or placebo . the primary end point was a composite of death or definite or probable invasive candidiasis prior to study day @ ( @ week after completion of study drug ) . secondary and safety outcomes included invasive candidiasis , liver function , bacterial infection , length of stay , intracranial hemorrhage , periventricular leukomalacia , chronic lung disease , patent ductus arteriosus requiring surgery , retinopathy of prematurity requiring surgery , necrotizing enterocolitis , spontaneous intestinal perforation , and neurodevelopmental outcomes-defined as a bayley-iii cognition composite score of less than @ , blindness , deafness , or cerebral palsy at @ to @ months corrected age . among infants receiving fluconazole , the composite primary end point of death or invasive candidiasis was @ % ( @ % ci , @ % -@ % ) vs @ % in the placebo group ( @ % ci , @ % -@ % ; odds ratio , @ -lsb- @ % ci , @-@ @ -rsb- ; p = @ ; treatment difference , -@ % -lsb- @ % ci , -@ % to @ % -rsb- ) . invasive candidiasis occurred less frequently in the fluconazole group ( @ % -lsb- @ % ci , @ % -@ % -rsb- ) vs the placebo group ( @ % -lsb- @ % ci , @ % -@ % -rsb- ; p = @ ; treatment difference , -@ % -lsb- @ % ci , -@ % to -@ % -rsb- ) . the cumulative incidences of other secondary outcomes were not statistically different between groups . neurodevelopmental impairment did not differ between the groups ( fluconazole , @ % -lsb- @ % ci , @ % -@ % -rsb- vs placebo , @ % -lsb- @ % ci , @ % -@ % -rsb- ; p = @ ; treatment difference , @ % -lsb- @ % ci , -@ % to @ % -rsb- ) . among infants with a birth weight of less than @ g , @ days of fluconazole prophylaxis compared with placebo did not result in a lower incidence of the composite of death or invasive candidiasis . these findings do not support the universal use of prophylactic fluconazole in extremely low-birth-weight infants . clinicaltrials.gov identifier : nct@ .
24,794,367
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "bone metastases frequently cause skeletal events in patients with metastatic castration-resistant prostate cancer .", "radium-@ dichloride ( radium-@ ) selectively targets bone metastases with high-energy , short-range - particles .", "we assessed the effect of radium-@ compared with placebo in patients with castration-resistant prostate cancer and bone metastases .", "in this phase @ , double-blind , randomised alsympca trial , we enrolled patients who had symptomatic castration-resistant prostate cancer with two or more bone metastases and no known visceral metastases , who were receiving best standard of care , and had previously either received or were unsuitable for docetaxel .", "patients were stratified by previous docetaxel use , baseline total alkaline phosphatase level , and current bisphosphonate use , then randomly assigned ( @:@ ) to receive either six intravenous injections of radium-@ ( @ kbq/kg ) or matching placebo ; one injection was given every @ weeks .", "randomisation was done with an interactive voice response system , taking into account trial stratification factors .", "participants and investigators were masked to treatment assignment .", "the primary endpoint was overall survival , which has been reported previously .", "here we report on time to first symptomatic skeletal event , defined as the use of external beam radiation to relieve bone pain , or occurrence of a new symptomatic pathological fracture ( vertebral or non-verterbal ) , or occurence of spinal cord compression , or tumour-related orthopeadic surgical intervention .", "all events were required to be clinically apparent and were not assessed by periodic radiological review .", "statistical analyses of symptomatic skeletal events were based on the intention-to-treat population .", "the study has been completed and is registered with clinicaltrials.gov , number nct@ .", "between june @ , @ , and feb @ , @ , @ patients were enrolled , of whom @ ( @ % ) were randomly assigned to receive radium-@ and @ ( @ % ) placebo .", "symptomatic skeletal events occurred in @ ( @ % ) of @ patients in the radium-@ group and @ ( @ % ) of @ patients in the placebo group .", "time to first symptomatic skeletal event was longer with radium-@ than with placebo ( median @ months -lsb- @ % ci @-@ -rsb- vs @ months -lsb- @-@ -rsb- ; hazard ratio -lsb- hr -rsb- = @ , @ % ci @-@ ; p = @ ) .", "the risks of external beam radiation therapy for bone pain ( hr @ , @ % ci @-@ ) and spinal cord compression ( hr = @ , @ % ci @-@ ) were reduced with radium-@ compared with placebo .", "radium-@ treatment did not seem to significantly reduce the risk of symptomatic pathological bone fracture ( hr @ , @ % ci @-@ ) , or the need for tumour-related orthopaedic surgical intervention ( hr @ , @ % ci @-@ ) .", "radium-@ should be considered as a treatment option for patients with castration-resistant prostate cancer and symptomatic bone metastases .", "algeta and bayer healthcare pharmaceuticals ." ]
bone metastases frequently cause skeletal events in patients with metastatic castration-resistant prostate cancer . radium-@ dichloride ( radium-@ ) selectively targets bone metastases with high-energy , short-range - particles . we assessed the effect of radium-@ compared with placebo in patients with castration-resistant prostate cancer and bone metastases . in this phase @ , double-blind , randomised alsympca trial , we enrolled patients who had symptomatic castration-resistant prostate cancer with two or more bone metastases and no known visceral metastases , who were receiving best standard of care , and had previously either received or were unsuitable for docetaxel . patients were stratified by previous docetaxel use , baseline total alkaline phosphatase level , and current bisphosphonate use , then randomly assigned ( @:@ ) to receive either six intravenous injections of radium-@ ( @ kbq/kg ) or matching placebo ; one injection was given every @ weeks . randomisation was done with an interactive voice response system , taking into account trial stratification factors . participants and investigators were masked to treatment assignment . the primary endpoint was overall survival , which has been reported previously . here we report on time to first symptomatic skeletal event , defined as the use of external beam radiation to relieve bone pain , or occurrence of a new symptomatic pathological fracture ( vertebral or non-verterbal ) , or occurence of spinal cord compression , or tumour-related orthopeadic surgical intervention . all events were required to be clinically apparent and were not assessed by periodic radiological review . statistical analyses of symptomatic skeletal events were based on the intention-to-treat population . the study has been completed and is registered with clinicaltrials.gov , number nct@ . between june @ , @ , and feb @ , @ , @ patients were enrolled , of whom @ ( @ % ) were randomly assigned to receive radium-@ and @ ( @ % ) placebo . symptomatic skeletal events occurred in @ ( @ % ) of @ patients in the radium-@ group and @ ( @ % ) of @ patients in the placebo group . time to first symptomatic skeletal event was longer with radium-@ than with placebo ( median @ months -lsb- @ % ci @-@ -rsb- vs @ months -lsb- @-@ -rsb- ; hazard ratio -lsb- hr -rsb- = @ , @ % ci @-@ ; p = @ ) . the risks of external beam radiation therapy for bone pain ( hr @ , @ % ci @-@ ) and spinal cord compression ( hr = @ , @ % ci @-@ ) were reduced with radium-@ compared with placebo . radium-@ treatment did not seem to significantly reduce the risk of symptomatic pathological bone fracture ( hr @ , @ % ci @-@ ) , or the need for tumour-related orthopaedic surgical intervention ( hr @ , @ % ci @-@ ) . radium-@ should be considered as a treatment option for patients with castration-resistant prostate cancer and symptomatic bone metastases . algeta and bayer healthcare pharmaceuticals .
24,836,273
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]
[ "discontinuation of bisphosphonate therapy after @ to @ years is increasingly considered , but methods to monitor fracture risk after discontinuation have not been established .", "to test methods of predicting fracture risk among women who have discontinued alendronate therapy after @ to @ years .", "the prospective fracture intervention trial long-term extension ( flex ) study randomized postmenopausal women aged @ to @ years previously treated with @ to @ years of alendronate therapy to @ more years of alendronate or placebo from @ through @ ; the present analysis includes only the placebo group .", "hip and spine dual-energy x-ray absorptiometry ( dxa ) were measured when placebo was begun ( flex baseline ) and after @ to @ years of follow-up .", "two biochemical markers of bone turnover , urinary type @ collagen cross-linked n-telopeptide ( ntx ) and serum bone-specific alkaline phosphatase ( bap ) , were measured at flex baseline and after @ and @ years .", "symptomatic spine and nonspine fractures occurring after the follow-up measurement of dxa or bone turnover .", "during @ years of placebo , @ of @ women ( @ % ) experienced @ or more symptomatic fractures ; @ had fractures after @ year .", "one-year changes in hip dxa , ntx , and bap were not related to subsequent fracture risk , but older age and lower hip dxa at time of discontinuation were significantly related to increased fracture risk ( lowest tertile of baseline femoral neck dxa vs other @ tertiles relative hazard ratio , @ -lsb- @ % ci , @-@ @ -rsb- ; total hip dxa relative hazard ratio , @ -lsb- @ % ci , @-@ @ -rsb- ) .", "among postmenopausal women who discontinue alendronate therapy after @ to @ years , age and hip bmd at discontinuation predict clinical fractures during the subsequent @ years .", "follow-up measurements of dxa @ year after discontinuation and of bap or ntx @ to @ years after discontinuation are not associated with fracture risk and can not be recommended .", "clinicaltrials.gov identifier : nct@ ." ]
discontinuation of bisphosphonate therapy after @ to @ years is increasingly considered , but methods to monitor fracture risk after discontinuation have not been established . to test methods of predicting fracture risk among women who have discontinued alendronate therapy after @ to @ years . the prospective fracture intervention trial long-term extension ( flex ) study randomized postmenopausal women aged @ to @ years previously treated with @ to @ years of alendronate therapy to @ more years of alendronate or placebo from @ through @ ; the present analysis includes only the placebo group . hip and spine dual-energy x-ray absorptiometry ( dxa ) were measured when placebo was begun ( flex baseline ) and after @ to @ years of follow-up . two biochemical markers of bone turnover , urinary type @ collagen cross-linked n-telopeptide ( ntx ) and serum bone-specific alkaline phosphatase ( bap ) , were measured at flex baseline and after @ and @ years . symptomatic spine and nonspine fractures occurring after the follow-up measurement of dxa or bone turnover . during @ years of placebo , @ of @ women ( @ % ) experienced @ or more symptomatic fractures ; @ had fractures after @ year . one-year changes in hip dxa , ntx , and bap were not related to subsequent fracture risk , but older age and lower hip dxa at time of discontinuation were significantly related to increased fracture risk ( lowest tertile of baseline femoral neck dxa vs other @ tertiles relative hazard ratio , @ -lsb- @ % ci , @-@ @ -rsb- ; total hip dxa relative hazard ratio , @ -lsb- @ % ci , @-@ @ -rsb- ) . among postmenopausal women who discontinue alendronate therapy after @ to @ years , age and hip bmd at discontinuation predict clinical fractures during the subsequent @ years . follow-up measurements of dxa @ year after discontinuation and of bap or ntx @ to @ years after discontinuation are not associated with fracture risk and can not be recommended . clinicaltrials.gov identifier : nct@ .
24,798,675
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "decreased ability of muscles to respond to anabolic stimuli is part of the underlying mechanism for muscle loss with aging .", "previous studies suggest that substantial amounts of essential amino acids ( eaa ) , whey protein and leucine are beneficial for stimulation of acute muscle protein synthesis in older adults .", "however , these studies supplied only proteins , and no bolus studies have been done with dairy products or supplements that contained also fat and carbohydrates besides proteins .", "the aim of this study was to evaluate whether a specifically designed nutritional supplement in older adults stimulates muscle protein synthesis acutely to a greater extent than a conventional dairy product .", "moreover , the combined effect with resistance exercise was studied by using a unilateral resistance exercise protocol .", "utilizing a randomized , controlled , double blind study design , healthy older adults received a single bolus of a high whey protein , leucine-enriched supplement ( exp : @ g whey protein , @g total leucine , @ kcal ; n = @ ) or an iso-caloric milk protein control (", "@g milk protein ; n = @ ) , immediately after unilateral resistance exercise .", "postprandial mixed muscle protein fractional synthesis rate ( fsr ) was measured over @h using a tracer infusion protocol with l - -lsb- ring-c -rsb- - phenylalanine and regular blood and muscle sampling .", "fsr was significantly higher overall after exp ( @ % / h ) vs control ( @ % / h ( emmse ) ) ( p = @ ) .", "no interaction between treatment and exercise was observed ( p = @ ) .", "higher postprandial concentrations of eaa and leucine are possible mediating factors for the fsr response , while plasma insulin increase did not dictate the fsr response .", "moreover , when the protein intake from the supplements was expressed per kg leg lean mass ( llm ) , a significant correlation was observed with resting postprandial fsr ( r = @ , p = @ ) .", "ingestion of a high whey protein , leucine-enriched supplement resulted in a larger overall postprandial muscle protein synthesis rate in healthy older subjects compared with a conventional dairy product .", "this acute effect is promising for long-term effects on parameters of muscle mass , strength and function in sarcopenic older people , which requires further study .", "this trial is registered in the dutch trial register under number ntr@ ." ]
decreased ability of muscles to respond to anabolic stimuli is part of the underlying mechanism for muscle loss with aging . previous studies suggest that substantial amounts of essential amino acids ( eaa ) , whey protein and leucine are beneficial for stimulation of acute muscle protein synthesis in older adults . however , these studies supplied only proteins , and no bolus studies have been done with dairy products or supplements that contained also fat and carbohydrates besides proteins . the aim of this study was to evaluate whether a specifically designed nutritional supplement in older adults stimulates muscle protein synthesis acutely to a greater extent than a conventional dairy product . moreover , the combined effect with resistance exercise was studied by using a unilateral resistance exercise protocol . utilizing a randomized , controlled , double blind study design , healthy older adults received a single bolus of a high whey protein , leucine-enriched supplement ( exp : @ g whey protein , @g total leucine , @ kcal ; n = @ ) or an iso-caloric milk protein control ( @g milk protein ; n = @ ) , immediately after unilateral resistance exercise . postprandial mixed muscle protein fractional synthesis rate ( fsr ) was measured over @h using a tracer infusion protocol with l - -lsb- ring-c -rsb- - phenylalanine and regular blood and muscle sampling . fsr was significantly higher overall after exp ( @ % / h ) vs control ( @ % / h ( emmse ) ) ( p = @ ) . no interaction between treatment and exercise was observed ( p = @ ) . higher postprandial concentrations of eaa and leucine are possible mediating factors for the fsr response , while plasma insulin increase did not dictate the fsr response . moreover , when the protein intake from the supplements was expressed per kg leg lean mass ( llm ) , a significant correlation was observed with resting postprandial fsr ( r = @ , p = @ ) . ingestion of a high whey protein , leucine-enriched supplement resulted in a larger overall postprandial muscle protein synthesis rate in healthy older subjects compared with a conventional dairy product . this acute effect is promising for long-term effects on parameters of muscle mass , strength and function in sarcopenic older people , which requires further study . this trial is registered in the dutch trial register under number ntr@ .
24,450,500
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "to determine the effectiveness of a pedometer-based telephone lifestyle coaching intervention on weight and physical activity .", "a randomized controlled trial was conducted with @ patients referred to cardiac rehabilitation in rural and urban australia .", "participants were allocated to a healthy weight ( hw ) ( @ telephone coaching sessions on weight and physical activity ) or a physical activity ( pa ) intervention ( @ telephone coaching sessions on physical activity ) .", "weight and physical activity were assessed by self-report at baseline , short-term ( @-@ weeks ) , and medium-term ( @-@ months ) .", "more than @ % of participants completed the trial .", "over the medium-term , participants in the hw group decreased their weight compared with participants in the pa group ( p = @ ) .", "participants in the hw group with a body mass index of @ kg/m had a mean weight loss of @ kg compared with participants in the pa-only group who lost a mean of @ kg ( p = @ ) .", "short-term , both groups increased their physical activity time , and the pa group maintained this increase at the medium-term .", "participants in the hw group achieved modest improvements in weight , and those in the pa group demonstrated increased physical activity .", "low-contact , telephone-based interventions are a feasible means of delivering lifestyle interventions for underserved rural communities , for those not attending cardiac rehabilitation , or as an adjunct to cardiac rehabilitation ." ]
to determine the effectiveness of a pedometer-based telephone lifestyle coaching intervention on weight and physical activity . a randomized controlled trial was conducted with @ patients referred to cardiac rehabilitation in rural and urban australia . participants were allocated to a healthy weight ( hw ) ( @ telephone coaching sessions on weight and physical activity ) or a physical activity ( pa ) intervention ( @ telephone coaching sessions on physical activity ) . weight and physical activity were assessed by self-report at baseline , short-term ( @-@ weeks ) , and medium-term ( @-@ months ) . more than @ % of participants completed the trial . over the medium-term , participants in the hw group decreased their weight compared with participants in the pa group ( p = @ ) . participants in the hw group with a body mass index of @ kg/m had a mean weight loss of @ kg compared with participants in the pa-only group who lost a mean of @ kg ( p = @ ) . short-term , both groups increased their physical activity time , and the pa group maintained this increase at the medium-term . participants in the hw group achieved modest improvements in weight , and those in the pa group demonstrated increased physical activity . low-contact , telephone-based interventions are a feasible means of delivering lifestyle interventions for underserved rural communities , for those not attending cardiac rehabilitation , or as an adjunct to cardiac rehabilitation .
25,313,450
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to compare the kinematics of lower limb joints between individuals with and without chronic ankle instability ( cai ) during cross-turn and - cutting movements .", "cross-sectional study .", "motion analysis laboratory .", "twelve subjects with cai and twelve healthy controls .", "hip flexion , adduction , and internal rotation , knee flexion , and ankle dorsiflexion and inversion angles were calculated in the @ms before initial ground contact and from initial ground contact to toe-off ( stance phase ) in a cross-turn movement during gait and a cross-cutting movement from a forward jump , and compared across the two groups .", "in the cross-cutting movement , the cai group exhibited greater hip and knee flexion than the control group during the stance phase , and more hip abduction during the period before initial contact and the stance phase .", "in the cross-turn movement the joint kinematics were similar in the two groups .", "cai subjects exhibited an altered pattern of the proximal joint kinematics during a cross-cutting movement .", "it is important for clinicians to assess the function of the hip and knee as well as the ankle , and to incorporate coordination training for the entire lower limb into rehabilitation after lateral ankle sprains ." ]
to compare the kinematics of lower limb joints between individuals with and without chronic ankle instability ( cai ) during cross-turn and - cutting movements . cross-sectional study . motion analysis laboratory . twelve subjects with cai and twelve healthy controls . hip flexion , adduction , and internal rotation , knee flexion , and ankle dorsiflexion and inversion angles were calculated in the @ms before initial ground contact and from initial ground contact to toe-off ( stance phase ) in a cross-turn movement during gait and a cross-cutting movement from a forward jump , and compared across the two groups . in the cross-cutting movement , the cai group exhibited greater hip and knee flexion than the control group during the stance phase , and more hip abduction during the period before initial contact and the stance phase . in the cross-turn movement the joint kinematics were similar in the two groups . cai subjects exhibited an altered pattern of the proximal joint kinematics during a cross-cutting movement . it is important for clinicians to assess the function of the hip and knee as well as the ankle , and to incorporate coordination training for the entire lower limb into rehabilitation after lateral ankle sprains .
24,618,282
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "it is thought that therapy should be functional , be highly repetitive , and promote afferent input to best stimulate hand motor recovery after stroke , yet patients struggle to access such therapy .", "we developed the musicglove , an instrumented glove that requires the user to practice gripping-like movements and thumb-finger opposition to play a highly engaging , music-based , video game .", "the purpose of this study was to @ ) compare the effect of training with musicglove to conventional hand therapy @ ) determine if musicglove training was more effective than a matched form of isometric hand movement training ; and @ ) determine if musicglove game scores predict clinical outcomes .", "@ chronic stroke survivors with moderate hemiparesis were randomly assigned to receive musicglove , isometric , and conventional hand therapy in a within-subjects design .", "each subject participated in six one-hour treatment sessions three times per week for two weeks , for each training type , for a total of @ treatment sessions .", "a blinded rater assessed hand impairment before and after each training type and at one-month follow-up including the box and blocks ( b & b ) test as the primary outcome measure .", "subjects also completed the intrinsic motivation inventory ( imi ) .", "subjects improved hand function related to grasping small objects more after musicglove compared to conventional training , as measured by the b & b score ( improvement of @ vs. -@ blocks ; p = @ ) and the @ hole peg test ( improvement of @ vs. -@ pegs/minute ; p = @ ) .", "there was no significant difference between training types in the broader assessment batteries of hand function .", "subjects benefited less from isometric therapy than musicglove training , but the difference was not significant ( p > @ ) .", "subjects sustained improvements in hand function at a one month follow-up , and found the musicglove more motivating than the other two therapies , as measured by the imi .", "musicglove games scores correlated strongly with the b & b score .", "these results support the hypothesis that hand therapy that is engaging , incorporates high numbers of repetitions of gripping and thumb-finger opposition movements , and promotes afferent input is a promising approach to improving an individual 's ability to manipulate small objects .", "the musicglove provides a simple way to access such therapy ." ]
it is thought that therapy should be functional , be highly repetitive , and promote afferent input to best stimulate hand motor recovery after stroke , yet patients struggle to access such therapy . we developed the musicglove , an instrumented glove that requires the user to practice gripping-like movements and thumb-finger opposition to play a highly engaging , music-based , video game . the purpose of this study was to @ ) compare the effect of training with musicglove to conventional hand therapy @ ) determine if musicglove training was more effective than a matched form of isometric hand movement training ; and @ ) determine if musicglove game scores predict clinical outcomes . @ chronic stroke survivors with moderate hemiparesis were randomly assigned to receive musicglove , isometric , and conventional hand therapy in a within-subjects design . each subject participated in six one-hour treatment sessions three times per week for two weeks , for each training type , for a total of @ treatment sessions . a blinded rater assessed hand impairment before and after each training type and at one-month follow-up including the box and blocks ( b & b ) test as the primary outcome measure . subjects also completed the intrinsic motivation inventory ( imi ) . subjects improved hand function related to grasping small objects more after musicglove compared to conventional training , as measured by the b & b score ( improvement of @ vs. -@ blocks ; p = @ ) and the @ hole peg test ( improvement of @ vs. -@ pegs/minute ; p = @ ) . there was no significant difference between training types in the broader assessment batteries of hand function . subjects benefited less from isometric therapy than musicglove training , but the difference was not significant ( p > @ ) . subjects sustained improvements in hand function at a one month follow-up , and found the musicglove more motivating than the other two therapies , as measured by the imi . musicglove games scores correlated strongly with the b & b score . these results support the hypothesis that hand therapy that is engaging , incorporates high numbers of repetitions of gripping and thumb-finger opposition movements , and promotes afferent input is a promising approach to improving an individual 's ability to manipulate small objects . the musicglove provides a simple way to access such therapy .
24,885,076
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "current us healthcare delivery systems do not adequately address healthcare demands .", "physicians are integral but rarely emphasize prevention as a primary tool to change health outcomes .", "home visitation is an effective method for changing health outcomes in some populations .", "the florida international university herbert wertheim college of medicine green family foundation neighborhoodhelp service-learning program assigns medical students to be members of interprofessional teams that conduct household visits to determine their healthcare needs .", "we performed a prospective evaluation of @ households randomly assigned to one of two groups : visitation from a student team ( intervention group ) or limited intervention ( control group ) .", "the program design allowed randomly selected control households to replace intervention-group households that left the program of their own volition .", "all of the households were surveyed at baseline and after @ year of participation in the study .", "after @ year in the program and after adjustment for confounders , intervention group households proved more likely ( p @ ) than control households to have undergone physical examinations , blood pressure monitoring , and cervical cytology screenings .", "cholesterol screenings and mammograms were borderline significant ( p = @ and p = @ , respectively ) .", "this study supports the value of home visitation by interprofessional student teams as an effective way to increase the use of preventive health measures .", "the study underscores the important role interprofessional student teams may play in improving the health of us communities , while students concurrently learn about primary prevention and primary care ." ]
current us healthcare delivery systems do not adequately address healthcare demands . physicians are integral but rarely emphasize prevention as a primary tool to change health outcomes . home visitation is an effective method for changing health outcomes in some populations . the florida international university herbert wertheim college of medicine green family foundation neighborhoodhelp service-learning program assigns medical students to be members of interprofessional teams that conduct household visits to determine their healthcare needs . we performed a prospective evaluation of @ households randomly assigned to one of two groups : visitation from a student team ( intervention group ) or limited intervention ( control group ) . the program design allowed randomly selected control households to replace intervention-group households that left the program of their own volition . all of the households were surveyed at baseline and after @ year of participation in the study . after @ year in the program and after adjustment for confounders , intervention group households proved more likely ( p @ ) than control households to have undergone physical examinations , blood pressure monitoring , and cervical cytology screenings . cholesterol screenings and mammograms were borderline significant ( p = @ and p = @ , respectively ) . this study supports the value of home visitation by interprofessional student teams as an effective way to increase the use of preventive health measures . the study underscores the important role interprofessional student teams may play in improving the health of us communities , while students concurrently learn about primary prevention and primary care .
24,937,510
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to observe the effect of detoxifying and blood circulation activating chinese herb extraction of polygonum cuspidatum and hawthorn on carotid intima-media thickness ( imt ) , plaque integral and plaque stability related serum indexes of patients with carotid atherosclerosis .", "sixty and four cases of carotid artery atherosclerosis patients were assigned randomly to @ groups : detoxifying and blood circulation activating treatment group ( treatment group , @ cases ) and control group ( @ cases ) .", "patients in treatment group were treated with capsules of extraction of polygonum cuspidatum and hawthorn , @ pill po , bid ( dosage of administration : polygonum cuspidatum extraction @ mg x kg ( -@ ) x d ( -@ ) , hawthorn extraction @ mg x kg ( -@ ) x d ( -@ ) ) ; patients in control group were treated with lovastatin @ mg po , qd ( dosage of administration : @ mg x kg ( -@ ) x d ( -@ ) ) .", "the course of treatment was six months .", "to observe changes of imt , plaque integral , and detect the level of plaque stability related serum indexes such as hs-crp , mmp-@ and timp-@ .", "after @ months of treatment , in control group one patient quit the clinical trial because of liver dysfunction and one patient was rejected because of having not followed the therapeutic regimen .", "@ cases in treatment group and @ cases in control group were analyzed .", "the results showed that imt and plaque integral of treatment group decreased significantly after the treatment ( p < @ , p < @ ) , and there was no significant difference compared with control grope .", "serum hs-crp , mmp-@ and mmp-@ / timp-@ decreased after the treatment ( p < @ , p < @ ) , and the treatment group was superior to control group in decreasing serum hs-crp ( p < @ ) .", "detoxifying and blood circulation activating chinese herb extraction of polygonum cuspidatum and hawthorn has good effect of anti-atherosclerosis and promoting plaque stability .", "its mechanism might be related with anti-inflammation and inhibiting degradation of extracellular matrix , and deserves further studies ." ]
to observe the effect of detoxifying and blood circulation activating chinese herb extraction of polygonum cuspidatum and hawthorn on carotid intima-media thickness ( imt ) , plaque integral and plaque stability related serum indexes of patients with carotid atherosclerosis . sixty and four cases of carotid artery atherosclerosis patients were assigned randomly to @ groups : detoxifying and blood circulation activating treatment group ( treatment group , @ cases ) and control group ( @ cases ) . patients in treatment group were treated with capsules of extraction of polygonum cuspidatum and hawthorn , @ pill po , bid ( dosage of administration : polygonum cuspidatum extraction @ mg x kg ( -@ ) x d ( -@ ) , hawthorn extraction @ mg x kg ( -@ ) x d ( -@ ) ) ; patients in control group were treated with lovastatin @ mg po , qd ( dosage of administration : @ mg x kg ( -@ ) x d ( -@ ) ) . the course of treatment was six months . to observe changes of imt , plaque integral , and detect the level of plaque stability related serum indexes such as hs-crp , mmp-@ and timp-@ . after @ months of treatment , in control group one patient quit the clinical trial because of liver dysfunction and one patient was rejected because of having not followed the therapeutic regimen . @ cases in treatment group and @ cases in control group were analyzed . the results showed that imt and plaque integral of treatment group decreased significantly after the treatment ( p < @ , p < @ ) , and there was no significant difference compared with control grope . serum hs-crp , mmp-@ and mmp-@ / timp-@ decreased after the treatment ( p < @ , p < @ ) , and the treatment group was superior to control group in decreasing serum hs-crp ( p < @ ) . detoxifying and blood circulation activating chinese herb extraction of polygonum cuspidatum and hawthorn has good effect of anti-atherosclerosis and promoting plaque stability . its mechanism might be related with anti-inflammation and inhibiting degradation of extracellular matrix , and deserves further studies .
24,956,862
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "hip fractures are a leading cause of mortality and disability worldwide , and the number of hip fractures is expected to rise to over @ million per year by @ .", "the optimal approach for the surgical management of displaced femoral neck fractures remains unknown .", "current evidence suggests the use of arthroplasty ; however , there is lack of evidence regarding whether patients with displaced femoral neck fractures experience better outcomes with total hip arthroplasty ( tha ) or hemiarthroplasty ( ha ) .", "the health trial compares outcomes following tha versus ha in patients @years of age or older with displaced femoral neck fractures .", "health is a multicentre , randomised controlled trial where @ patients , @years of age or older , with displaced femoral neck fractures from international sites are randomised to receive either tha or ha .", "exclusion criteria include associated major injuries of the lower extremity , hip infection ( s ) and a history of frank dementia .", "the primary outcome is unplanned secondary procedures and the secondary outcomes include functional outcomes , patient quality of life , mortality and hip-related complications-both within @years of the initial surgery .", "we are using minimisation to ensure balance between intervention groups for the following factors : age , prefracture living , prefracture functional status , american society for anesthesiologists ( asa ) class and centre number .", "data analysts and the health steering committee are blinded to the surgical allocation throughout the trial .", "outcome analysis will be performed using a ( @ ) test ( or fisher 's exact test ) and cox proportional hazards modelling estimate .", "all results will be presented with @ % cis .", "the health trial has received local and mcmaster university research ethics board ( reb ) approval ( reb # : @-@ ) .", "outcomes from the primary manuscript will be disseminated through publications in academic journals and presentations at relevant orthopaedic conferences .", "we will communicate trial results to all participating sites .", "participating sites will communicate results with patients who have indicated an interest in knowing the results .", "the health trial is registered with clinicaltrials.gov ( nct@ ) ." ]
hip fractures are a leading cause of mortality and disability worldwide , and the number of hip fractures is expected to rise to over @ million per year by @ . the optimal approach for the surgical management of displaced femoral neck fractures remains unknown . current evidence suggests the use of arthroplasty ; however , there is lack of evidence regarding whether patients with displaced femoral neck fractures experience better outcomes with total hip arthroplasty ( tha ) or hemiarthroplasty ( ha ) . the health trial compares outcomes following tha versus ha in patients @years of age or older with displaced femoral neck fractures . health is a multicentre , randomised controlled trial where @ patients , @years of age or older , with displaced femoral neck fractures from international sites are randomised to receive either tha or ha . exclusion criteria include associated major injuries of the lower extremity , hip infection ( s ) and a history of frank dementia . the primary outcome is unplanned secondary procedures and the secondary outcomes include functional outcomes , patient quality of life , mortality and hip-related complications-both within @years of the initial surgery . we are using minimisation to ensure balance between intervention groups for the following factors : age , prefracture living , prefracture functional status , american society for anesthesiologists ( asa ) class and centre number . data analysts and the health steering committee are blinded to the surgical allocation throughout the trial . outcome analysis will be performed using a ( @ ) test ( or fisher 's exact test ) and cox proportional hazards modelling estimate . all results will be presented with @ % cis . the health trial has received local and mcmaster university research ethics board ( reb ) approval ( reb # : @-@ ) . outcomes from the primary manuscript will be disseminated through publications in academic journals and presentations at relevant orthopaedic conferences . we will communicate trial results to all participating sites . participating sites will communicate results with patients who have indicated an interest in knowing the results . the health trial is registered with clinicaltrials.gov ( nct@ ) .
25,681,312
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "BACKGROUND", "RESULTS", "RESULTS", "RESULTS", "BACKGROUND" ]
[ "to observe the difference in the analgesic effect on primary dysmenorrheal between acupuncture and sham acupuncture at sanyinjiao ( sp @ ) during menstrual pain and evaluate the impact of psychological effect on acupuncture analgesia .", "sixty subjects were randomized into an acupuncture group and a sham acupuncture group , @ cases in each one .", "the conventional acupuncture and sham acupuncture were applied to sanyinjiao ( sp @ ) on bilateral sides when menstrual pain began to attack and needles were retained for @ min each time .", "three menstrual cycles were required .", "the visual analogue scale ( vas ) was adopted to determine the scores before and @ h , @ h , @ h , @ h and @ h after acupuncture during menstrual pain in each cycle separately .", "in the acupuncture group , vas score at each time point after acupuncture was reduced as compared with that at the previous one during menstrual pain in each menstrual cycle , indicating the significant difference ( all p < @ ) .", "in the sham acupuncture group , the scores in @ h and @ h of acupuncture were reduced as compared with the previous one , indicating the significant difference ( all p < @ ) .", "after acupuncture , vas score at each time point in the acupuncture group was lower than that in the sham acupuncture group ( all p < @ ) .", "the conventional acupuncture at sanyinjiao ( sp @ ) achieves the significant analgesic effect on primary dysmenorrheal .", "the psychological placebo effect of sham acupuncture has no obvious impact on acupuncture analgesia ." ]
to observe the difference in the analgesic effect on primary dysmenorrheal between acupuncture and sham acupuncture at sanyinjiao ( sp @ ) during menstrual pain and evaluate the impact of psychological effect on acupuncture analgesia . sixty subjects were randomized into an acupuncture group and a sham acupuncture group , @ cases in each one . the conventional acupuncture and sham acupuncture were applied to sanyinjiao ( sp @ ) on bilateral sides when menstrual pain began to attack and needles were retained for @ min each time . three menstrual cycles were required . the visual analogue scale ( vas ) was adopted to determine the scores before and @ h , @ h , @ h , @ h and @ h after acupuncture during menstrual pain in each cycle separately . in the acupuncture group , vas score at each time point after acupuncture was reduced as compared with that at the previous one during menstrual pain in each menstrual cycle , indicating the significant difference ( all p < @ ) . in the sham acupuncture group , the scores in @ h and @ h of acupuncture were reduced as compared with the previous one , indicating the significant difference ( all p < @ ) . after acupuncture , vas score at each time point in the acupuncture group was lower than that in the sham acupuncture group ( all p < @ ) . the conventional acupuncture at sanyinjiao ( sp @ ) achieves the significant analgesic effect on primary dysmenorrheal . the psychological placebo effect of sham acupuncture has no obvious impact on acupuncture analgesia .
26,054,136
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the first multicenter randomized controlled trial was designed and conducted to assess the safety and effectiveness of totally percutaneous endovascular aortic aneurysm repair ( pevar ) with use of a @f endovascular stent graft system and either an @ f or @ f suture-mediated closure system ( the pevar trial , nct@ ) .", "a noninferiority trial design was chosen to compare percutaneous access with standard open femoral exposure .", "between @ and @ , @ u.s. institutions participated in a prospective , food and drug administration-approved randomized trial to evaluate percutaneous femoral artery access and closure by a `` preclose '' technique in conjunction with endovascular abdominal aortic aneurysm repair .", "a total of @ patients were allocated by a @:@ design to percutaneous access/closure ( n = @ ) or open femoral exposure ( n = @ -lsb- fe -rsb- ) .", "pevar procedures were performed with either the @ f perclose proglide ( n = @ -lsb- pg -rsb- ) or the @ f prostar xl ( n = @ -lsb- ps -rsb- ) closure devices .", "all endovascular abdominal aortic aneurysm repair procedures were performed with the endologix @ f profile ( outer diameter ) sheath-based system .", "patients were screened by computed tomography with three-dimensional reconstruction and independent physician review for anatomic suitability and adequate femoral artery anatomy for percutaneous access .", "the primary trial end point ( treatment success ) was defined as procedural technical success and absence of major adverse events and vascular complications at @ days .", "an independent access closure substudy evaluated major access-related complications .", "clinical utility and procedural outcomes , ankle-brachial index , blood laboratory analyses , and quality of life were also evaluated with continuing follow-up to @ months .", "baseline characteristics were similar among groups .", "procedural technical success was @ % ( pg ) , @ % ( ps ) , and @ % ( fe ) .", "one-month primary treatment success was @ % ( pg ) , @ % ( ps ) , and @ % ( fe ) , demonstrating noninferiority vs fe for pg ( p = @ ) but not for ps ( p = @ ) .", "failure rates in the access closure substudy analyses demonstrated noninferiority of pg ( @ % ; p = @ ) , but not of ps ( @ % ; p = @ ) , vs fe ( @ % ) .", "compared with fe , pg and ps yielded significantly shorter times to hemostasis and procedure completion and favorable trends in blood loss , groin pain , and overall quality of life .", "initial noninferiority test results persist to @ months , and no aneurysm rupture , conversion to open repair , device migration , or stent graft occlusion occurred .", "among trained operators , pevar with an adjunctive preclose technique using the proglide closure device is safe and effective , with minimal access-related complications , and it is noninferior to standard open femoral exposure .", "training , experience , and careful application of the preclose technique are of paramount importance in ensuring successful , sustainable outcomes ." ]
the first multicenter randomized controlled trial was designed and conducted to assess the safety and effectiveness of totally percutaneous endovascular aortic aneurysm repair ( pevar ) with use of a @f endovascular stent graft system and either an @ f or @ f suture-mediated closure system ( the pevar trial , nct@ ) . a noninferiority trial design was chosen to compare percutaneous access with standard open femoral exposure . between @ and @ , @ u.s. institutions participated in a prospective , food and drug administration-approved randomized trial to evaluate percutaneous femoral artery access and closure by a `` preclose '' technique in conjunction with endovascular abdominal aortic aneurysm repair . a total of @ patients were allocated by a @:@ design to percutaneous access/closure ( n = @ ) or open femoral exposure ( n = @ -lsb- fe -rsb- ) . pevar procedures were performed with either the @ f perclose proglide ( n = @ -lsb- pg -rsb- ) or the @ f prostar xl ( n = @ -lsb- ps -rsb- ) closure devices . all endovascular abdominal aortic aneurysm repair procedures were performed with the endologix @ f profile ( outer diameter ) sheath-based system . patients were screened by computed tomography with three-dimensional reconstruction and independent physician review for anatomic suitability and adequate femoral artery anatomy for percutaneous access . the primary trial end point ( treatment success ) was defined as procedural technical success and absence of major adverse events and vascular complications at @ days . an independent access closure substudy evaluated major access-related complications . clinical utility and procedural outcomes , ankle-brachial index , blood laboratory analyses , and quality of life were also evaluated with continuing follow-up to @ months . baseline characteristics were similar among groups . procedural technical success was @ % ( pg ) , @ % ( ps ) , and @ % ( fe ) . one-month primary treatment success was @ % ( pg ) , @ % ( ps ) , and @ % ( fe ) , demonstrating noninferiority vs fe for pg ( p = @ ) but not for ps ( p = @ ) . failure rates in the access closure substudy analyses demonstrated noninferiority of pg ( @ % ; p = @ ) , but not of ps ( @ % ; p = @ ) , vs fe ( @ % ) . compared with fe , pg and ps yielded significantly shorter times to hemostasis and procedure completion and favorable trends in blood loss , groin pain , and overall quality of life . initial noninferiority test results persist to @ months , and no aneurysm rupture , conversion to open repair , device migration , or stent graft occlusion occurred . among trained operators , pevar with an adjunctive preclose technique using the proglide closure device is safe and effective , with minimal access-related complications , and it is noninferior to standard open femoral exposure . training , experience , and careful application of the preclose technique are of paramount importance in ensuring successful , sustainable outcomes .
24,440,678
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the aim of this study was to investigate the efficacy of bladder training before removing the indwelling urinary catheter in patients with acute urinary retention ( aur ) associated with benign prostatic hyperplasia ( bph ) .", "in total , @ consecutive patients with their first episode of spontaneous aur associated with bph were enrolled in this prospective randomized controlled trial .", "they were randomly assigned to be given either pharmacological treatment combined with bladder training or pharmacological treatment ( tamsulosin @ mg and finasteride @ mg once daily ) with free drainage of urinary catheter for @ days , and a trial without catheter ( twoc ) was performed .", "data on patients ' baseline demographics , history of bph , international prostate symptom score , prostate size , serum prostate-specific antigen , intravesical prostatic protrusion , twoc success rates and related complications were collected and statistically analysed .", "the two groups of spontaneous aur patients with bph were given pharmacological treatment combined with bladder training before catheter removal ( n = @ ) or pharmacological treatment alone ( n = @ ) for @ days .", "all @ patients underwent a first twoc with an overall success rate of @ % after first @ days ' catheterization ; twoc was successful in @ % of cases in the intervention group and @ % in the control group .", "there was no statistically significant difference in twoc success rate between the two groups ( p > @ ) .", "this randomized controlled trial showed that bladder training before urinary catheter removal did not increase the chance of twoc success significantly in spontaneous aur patients with bph ." ]
the aim of this study was to investigate the efficacy of bladder training before removing the indwelling urinary catheter in patients with acute urinary retention ( aur ) associated with benign prostatic hyperplasia ( bph ) . in total , @ consecutive patients with their first episode of spontaneous aur associated with bph were enrolled in this prospective randomized controlled trial . they were randomly assigned to be given either pharmacological treatment combined with bladder training or pharmacological treatment ( tamsulosin @ mg and finasteride @ mg once daily ) with free drainage of urinary catheter for @ days , and a trial without catheter ( twoc ) was performed . data on patients ' baseline demographics , history of bph , international prostate symptom score , prostate size , serum prostate-specific antigen , intravesical prostatic protrusion , twoc success rates and related complications were collected and statistically analysed . the two groups of spontaneous aur patients with bph were given pharmacological treatment combined with bladder training before catheter removal ( n = @ ) or pharmacological treatment alone ( n = @ ) for @ days . all @ patients underwent a first twoc with an overall success rate of @ % after first @ days ' catheterization ; twoc was successful in @ % of cases in the intervention group and @ % in the control group . there was no statistically significant difference in twoc success rate between the two groups ( p > @ ) . this randomized controlled trial showed that bladder training before urinary catheter removal did not increase the chance of twoc success significantly in spontaneous aur patients with bph .
24,697,345
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "abstinence from chronic cocaine use is associated with abnormal sleep architecture .", "as sleep abnormalities are associated with clinical outcome in alcohol dependence , we hypothesized a similar relationship in cocaine dependence .", "we report data from a cocaine self-administration study ( n = @ ) and the placebo arm of a randomized clinical trial ( n = @ ) .", "self-administration participants underwent three cocaine self-administration sessions during a three-week inpatient stay .", "treatment participants underwent two weeks of inpatient followed by six weeks of outpatient treatment including once-weekly cognitive behavioral therapy .", "measurements included polysomnography from early and late in abstinence during the inpatient stays .", "clinical outcomes included amount of cocaine self-administered , urine tests , and self-reported use and withdrawal symptoms .", "change in slow-wave sleep from early to late abstinence ( sws ; p = @ ) , late abstinence rapid eye movement sleep ( rem ; p = @ ) , and late abstinence total sleep time ( p = @ ) were negatively correlated with the amount of cocaine self-administered .", "early abstinence rem was positively correlated with withdrawal symptoms ( p = @ ) .", "late abstinence rem was positively correlated with percent negative urines and maximum consecutive number of days abstinent ( both p < @ ) .", "sws was positively correlated with percent negative urines ( p = @ ) and participants with increased sws had greater percent negative urines ( p = @ ) and maximum consecutive number of days abstinent ( p = @ ) .", "correlations between sleep deficits and amount of cocaine self-administered , clinical outcomes , and severity of withdrawal symptoms underscore the relevance of sleep in clinical outcomes in the treatment of cocaine dependence ." ]
abstinence from chronic cocaine use is associated with abnormal sleep architecture . as sleep abnormalities are associated with clinical outcome in alcohol dependence , we hypothesized a similar relationship in cocaine dependence . we report data from a cocaine self-administration study ( n = @ ) and the placebo arm of a randomized clinical trial ( n = @ ) . self-administration participants underwent three cocaine self-administration sessions during a three-week inpatient stay . treatment participants underwent two weeks of inpatient followed by six weeks of outpatient treatment including once-weekly cognitive behavioral therapy . measurements included polysomnography from early and late in abstinence during the inpatient stays . clinical outcomes included amount of cocaine self-administered , urine tests , and self-reported use and withdrawal symptoms . change in slow-wave sleep from early to late abstinence ( sws ; p = @ ) , late abstinence rapid eye movement sleep ( rem ; p = @ ) , and late abstinence total sleep time ( p = @ ) were negatively correlated with the amount of cocaine self-administered . early abstinence rem was positively correlated with withdrawal symptoms ( p = @ ) . late abstinence rem was positively correlated with percent negative urines and maximum consecutive number of days abstinent ( both p < @ ) . sws was positively correlated with percent negative urines ( p = @ ) and participants with increased sws had greater percent negative urines ( p = @ ) and maximum consecutive number of days abstinent ( p = @ ) . correlations between sleep deficits and amount of cocaine self-administered , clinical outcomes , and severity of withdrawal symptoms underscore the relevance of sleep in clinical outcomes in the treatment of cocaine dependence .
25,124,303
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "randomized trial with a concurrent observational cohort study .", "to compare @-year outcomes of surgery with nonoperative care for symptomatic lumbar spinal stenosis .", "surgery for spinal stenosis has been shown to be more effective than nonoperative treatment during @ years , but longer-term data are less clear .", "surgical candidates from @ centers in @ us states with at least @ weeks of symptoms and confirmatory imaging were enrolled in a randomized cohort or observational cohort .", "treatment was standard , decompressive laminectomy versus standard nonoperative care .", "primary outcomes were sf-@ ( mos @-item short-form health survey ) bodily pain and physical function scales and the modified oswestry disability index assessed at @ weeks , @ months , @ months , and yearly up to @ years .", "data were obtained for @ % of participants in the randomized group and @ % of participants in the observational group at the @-year follow-up .", "intent-to-treat analyses showed no differences between randomized cohorts ; however , @ % of those randomized to surgery and @ % of those randomized to nonoperative had undergone surgery by @ years .", "as-treated analyses in the randomized group showed that the early benefit for surgery out to @ years converged over time , with no significant treatment effect of surgery seen in years @ to @ for any of the primary outcomes .", "in contrast , the observational group showed a stable advantage for surgery in all outcomes between years @ and @ .", "patients who were lost to follow-up were older , less well-educated , sicker , and had worse outcomes during the first @ years in both surgical and nonoperative arms .", "patients with symptomatic spinal stenosis show diminishing benefits of surgery in as-treated analyses of the randomized group between @ and @ years , whereas outcomes in the observational group remained stable .", "loss to follow-up of patients with worse early outcomes in both treatment groups could lead to overestimates of long-term outcomes but likely not bias treatment effect estimates ." ]
randomized trial with a concurrent observational cohort study . to compare @-year outcomes of surgery with nonoperative care for symptomatic lumbar spinal stenosis . surgery for spinal stenosis has been shown to be more effective than nonoperative treatment during @ years , but longer-term data are less clear . surgical candidates from @ centers in @ us states with at least @ weeks of symptoms and confirmatory imaging were enrolled in a randomized cohort or observational cohort . treatment was standard , decompressive laminectomy versus standard nonoperative care . primary outcomes were sf-@ ( mos @-item short-form health survey ) bodily pain and physical function scales and the modified oswestry disability index assessed at @ weeks , @ months , @ months , and yearly up to @ years . data were obtained for @ % of participants in the randomized group and @ % of participants in the observational group at the @-year follow-up . intent-to-treat analyses showed no differences between randomized cohorts ; however , @ % of those randomized to surgery and @ % of those randomized to nonoperative had undergone surgery by @ years . as-treated analyses in the randomized group showed that the early benefit for surgery out to @ years converged over time , with no significant treatment effect of surgery seen in years @ to @ for any of the primary outcomes . in contrast , the observational group showed a stable advantage for surgery in all outcomes between years @ and @ . patients who were lost to follow-up were older , less well-educated , sicker , and had worse outcomes during the first @ years in both surgical and nonoperative arms . patients with symptomatic spinal stenosis show diminishing benefits of surgery in as-treated analyses of the randomized group between @ and @ years , whereas outcomes in the observational group remained stable . loss to follow-up of patients with worse early outcomes in both treatment groups could lead to overestimates of long-term outcomes but likely not bias treatment effect estimates .
25,569,524
[ "METHODS", "OBJECTIVE", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "controlled , repeated-measures , single-blind randomized study .", "to determine the effect of cervical or thoracic manipulation on neurotensin , oxytocin , orexin a , and cortisol levels .", "previous studies have researched the effect of spinal manipulation on pain modulation and/or range of movement .", "however , there is little knowledge of the biochemical process that supports the antinociceptive effect of spinal manipulation .", "thirty asymptomatic subjects were randomly divided into @ groups : cervical manipulation ( n = @ ) , thoracic manipulation ( n = @ ) , and nonmanipulation ( control ) ( n = @ ) .", "blood samples were extracted before , immediately after , and @ hours after each intervention .", "neurotensin , oxytocin , and orexin a were determined in plasma using enzyme-linked immuno assay .", "cortisol was measured by microparticulate enzyme immuno assay in serum samples .", "immediately after the intervention , significantly higher values of neurotensin ( p < @ ) and oxytocin ( p < @ ) levels were observed with both cervical and thoracic manipulation , whereas cortisol concentration was increased only in the cervical manipulation group ( p < @ ) .", "no changes were detected for orexin a levels .", "two hours after the intervention , no significant differences were observed in between-group analysis .", "the mechanical stimulus provided by spinal manipulation triggers an increase in neurotensin , oxytocin , and cortisol blood levels .", "data suggest that the initial capability of the tissues to tolerate mechanical deformation affects the capacity of these tissues to produce an induction of neuropeptide expression ." ]
controlled , repeated-measures , single-blind randomized study . to determine the effect of cervical or thoracic manipulation on neurotensin , oxytocin , orexin a , and cortisol levels . previous studies have researched the effect of spinal manipulation on pain modulation and/or range of movement . however , there is little knowledge of the biochemical process that supports the antinociceptive effect of spinal manipulation . thirty asymptomatic subjects were randomly divided into @ groups : cervical manipulation ( n = @ ) , thoracic manipulation ( n = @ ) , and nonmanipulation ( control ) ( n = @ ) . blood samples were extracted before , immediately after , and @ hours after each intervention . neurotensin , oxytocin , and orexin a were determined in plasma using enzyme-linked immuno assay . cortisol was measured by microparticulate enzyme immuno assay in serum samples . immediately after the intervention , significantly higher values of neurotensin ( p < @ ) and oxytocin ( p < @ ) levels were observed with both cervical and thoracic manipulation , whereas cortisol concentration was increased only in the cervical manipulation group ( p < @ ) . no changes were detected for orexin a levels . two hours after the intervention , no significant differences were observed in between-group analysis . the mechanical stimulus provided by spinal manipulation triggers an increase in neurotensin , oxytocin , and cortisol blood levels . data suggest that the initial capability of the tissues to tolerate mechanical deformation affects the capacity of these tissues to produce an induction of neuropeptide expression .
24,450,367
[ "METHODS", "OBJECTIVE", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to identify the risk-predictive baseline profile patterns of demographic , genetic , immunologic , and metabolic markers and synthesize these patterns for risk prediction .", "rulefit is used to identify the risk-predictive baseline profile patterns of demographic , immunologic , and metabolic markers , using @ subjects who were randomized into the control arm of the prospective diabetes prevention trial-type @ ( dpt-@ ) study .", "a novel latent trait model is developed to synthesize these baseline profile patterns for disease risk prediction .", "the primary outcome was type @ diabetes ( t@d ) onset .", "we identified ten baseline profile patterns that were significantly predictive to the disease onset .", "using these ten baseline profile patterns , a risk prediction model was built based on the latent trait model , which produced superior prediction performance over existing risk score models for t@d .", "our results demonstrated that the underlying disease progression process of t@d can be detected through some risk-predictive patterns of demographic , immunologic , and metabolic markers .", "a synthesis of these patterns provided accurate prediction of disease onset , leading to more cost-effective design of prevention trials of t@d in the future ." ]
to identify the risk-predictive baseline profile patterns of demographic , genetic , immunologic , and metabolic markers and synthesize these patterns for risk prediction . rulefit is used to identify the risk-predictive baseline profile patterns of demographic , immunologic , and metabolic markers , using @ subjects who were randomized into the control arm of the prospective diabetes prevention trial-type @ ( dpt-@ ) study . a novel latent trait model is developed to synthesize these baseline profile patterns for disease risk prediction . the primary outcome was type @ diabetes ( t@d ) onset . we identified ten baseline profile patterns that were significantly predictive to the disease onset . using these ten baseline profile patterns , a risk prediction model was built based on the latent trait model , which produced superior prediction performance over existing risk score models for t@d . our results demonstrated that the underlying disease progression process of t@d can be detected through some risk-predictive patterns of demographic , immunologic , and metabolic markers . a synthesis of these patterns provided accurate prediction of disease onset , leading to more cost-effective design of prevention trials of t@d in the future .
24,926,781
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "vitamin d is a potent immunomodulator , but its impact on morbidity and mortality among infants remains unclear .", "the objective of the study was to prospectively assess the association of vitamin d status with mortality , morbidity , and growth during the first @ y of life .", "a prospective cohort of @ hiv-infected and @ hiv-exposed tanzanian infants enrolled in a randomized trial of multivitamins ( not including vitamin d ) was studied .", "serum @-hydroxyvitamin d -lsb- @ ( oh ) d -rsb- concentrations were measured at @-@ wk of age and infants were followed at monthly clinic visits until @ mo. .", "physicians performed a clinical exam every @ mo or when an illness was noted .", "serum @ ( oh ) d concentrations were ( means sds ) @ @ ng/ml and @ @ ng/ml for hiv-infected and hiv-exposed infants , respectively .", "unexpectedly , serum @ ( oh ) d concentrations @ ng/ml were significantly associated with higher mortality as compared to the @-@ @ ng/ml reference for hiv-infected ( hr : @ ; @ % ci : @ , @ ; p = @ ) and hiv-exposed ( hr : @ ; @ % ci : @ , @ ; p < @ ) infants after multivariate adjustment .", "we found no statistically significant association between @ ( oh ) d concentrations < @ ng/ml and mortality for hiv-infected ( hr : @ ; @ % ci : @ , @ ; p = @ ) and hiv-exposed ( hr : @ ; @ % ci : @ , @ ; p = @ ) infants .", "among hiv-exposed infants , @ ( oh ) d concentrations @ ng/ml were significantly associated with clinical -lsb- incidence ratio rate ( irr ) : @ ; @ % ci : @,@ ; p = @ -rsb- and confirmed ( irr : @ ; @ % ci : @ ; @ , @ ; p < @ ) malaria diagnoses , whereas concentrations of < @ ng/ml were associated with oral candidiasis ( irr : @ ; @ % ci : @-@ @ ; p = @ ) and wasting ( hr : @ ; @ % ci : @ , @ ; p < @ ) .", "the observational design of this study does not allow for causal interpretation ; however , the results indicate a strong need for additional studies of vitamin d among hiv-infected and - exposed children , particularly in malaria-endemic settings .", "the parent trial was registered at clinicaltrials.gov as nct@ ." ]
vitamin d is a potent immunomodulator , but its impact on morbidity and mortality among infants remains unclear . the objective of the study was to prospectively assess the association of vitamin d status with mortality , morbidity , and growth during the first @ y of life . a prospective cohort of @ hiv-infected and @ hiv-exposed tanzanian infants enrolled in a randomized trial of multivitamins ( not including vitamin d ) was studied . serum @-hydroxyvitamin d -lsb- @ ( oh ) d -rsb- concentrations were measured at @-@ wk of age and infants were followed at monthly clinic visits until @ mo. . physicians performed a clinical exam every @ mo or when an illness was noted . serum @ ( oh ) d concentrations were ( means sds ) @ @ ng/ml and @ @ ng/ml for hiv-infected and hiv-exposed infants , respectively . unexpectedly , serum @ ( oh ) d concentrations @ ng/ml were significantly associated with higher mortality as compared to the @-@ @ ng/ml reference for hiv-infected ( hr : @ ; @ % ci : @ , @ ; p = @ ) and hiv-exposed ( hr : @ ; @ % ci : @ , @ ; p < @ ) infants after multivariate adjustment . we found no statistically significant association between @ ( oh ) d concentrations < @ ng/ml and mortality for hiv-infected ( hr : @ ; @ % ci : @ , @ ; p = @ ) and hiv-exposed ( hr : @ ; @ % ci : @ , @ ; p = @ ) infants . among hiv-exposed infants , @ ( oh ) d concentrations @ ng/ml were significantly associated with clinical -lsb- incidence ratio rate ( irr ) : @ ; @ % ci : @,@ ; p = @ -rsb- and confirmed ( irr : @ ; @ % ci : @ ; @ , @ ; p < @ ) malaria diagnoses , whereas concentrations of < @ ng/ml were associated with oral candidiasis ( irr : @ ; @ % ci : @-@ @ ; p = @ ) and wasting ( hr : @ ; @ % ci : @ , @ ; p < @ ) . the observational design of this study does not allow for causal interpretation ; however , the results indicate a strong need for additional studies of vitamin d among hiv-infected and - exposed children , particularly in malaria-endemic settings . the parent trial was registered at clinicaltrials.gov as nct@ .
25,527,666
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "benzodiazepines , other anxiolytics , or sedative hypnotics are prescribed for @ % -@ % of posttraumatic stress disorder ( ptsd ) patients .", "prior data and theory suggest that these medications may inhibit response to exposure therapy , one of the most effective ptsd treatments .", "the present post hoc study reanalyzed results from a psychotherapy trial to assess whether benzodiazepine use was associated with reduced response to exposure therapy .", "between august @ and october @ , @ female veterans and soldiers meeting dsm-iv criteria for ptsd were randomly assigned to @ weekly @-minute sessions of either prolonged exposure ( n = @ ) or present-centered psychotherapy ( n = @ ) .", "benzodiazepine use ( n = @ ) or non-use ( n = @ ) at intake was not randomly assigned .", "multilevel modeling was used to assess the effects of benzodiazepine status , psychotherapy condition , and their interaction on changes on the clinician-administered ptsd scale and the ptsd checklist during the treatment and @-month follow-up periods .", "consistent with prior reports from these data , prolonged exposure psychotherapy produced greater reductions per week in ptsd symptoms than did present-centered psychotherapy ( b = -@ , p = @ ) .", "patients prescribed benzodiazepines did not have weaker response to prolonged exposure , but demonstrated poorer posttreatment maintenance of gains from present-centered psychotherapy ( b = -@ , p < @ ) .", "prolonged exposure is a sufficiently robust treatment that patients who are taking benzodiazepines can benefit from it .", "it is unclear whether benzodiazepine use or other patient factors accounted for benzodiazepine recipients ' poorer maintenance of gains in present-centered psychotherapy .", "clinicaltrials.gov identifier : nct@ ." ]
benzodiazepines , other anxiolytics , or sedative hypnotics are prescribed for @ % -@ % of posttraumatic stress disorder ( ptsd ) patients . prior data and theory suggest that these medications may inhibit response to exposure therapy , one of the most effective ptsd treatments . the present post hoc study reanalyzed results from a psychotherapy trial to assess whether benzodiazepine use was associated with reduced response to exposure therapy . between august @ and october @ , @ female veterans and soldiers meeting dsm-iv criteria for ptsd were randomly assigned to @ weekly @-minute sessions of either prolonged exposure ( n = @ ) or present-centered psychotherapy ( n = @ ) . benzodiazepine use ( n = @ ) or non-use ( n = @ ) at intake was not randomly assigned . multilevel modeling was used to assess the effects of benzodiazepine status , psychotherapy condition , and their interaction on changes on the clinician-administered ptsd scale and the ptsd checklist during the treatment and @-month follow-up periods . consistent with prior reports from these data , prolonged exposure psychotherapy produced greater reductions per week in ptsd symptoms than did present-centered psychotherapy ( b = -@ , p = @ ) . patients prescribed benzodiazepines did not have weaker response to prolonged exposure , but demonstrated poorer posttreatment maintenance of gains from present-centered psychotherapy ( b = -@ , p < @ ) . prolonged exposure is a sufficiently robust treatment that patients who are taking benzodiazepines can benefit from it . it is unclear whether benzodiazepine use or other patient factors accounted for benzodiazepine recipients ' poorer maintenance of gains in present-centered psychotherapy . clinicaltrials.gov identifier : nct@ .
24,434,093
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "the effects of hypoxic training on exercise performance remain controversial .", "here , we tested the hypotheses that i ) hypoxic training possesses ergogenic effects at sea level and altitude and ii ) the benefits are primarily mediated by improved mitochondrial function of the skeletal muscle .", "we determined aerobic performance ( incremental test to exhaustion and time trial for a set amount of work ) in moderately trained subjects undergoing @ wk of endurance training ( @-@ times per week , @ min per session ) in normoxia ( placebo , n = @ ) or normobaric hypoxia ( fio@ = @ , n = @ ) using a double-blind and randomized design .", "exercise tests were performed in normoxia and acute hypoxia ( fio@ = @ ) .", "skeletal muscle mitochondrial respiratory capacities and electron coupling efficiencies were measured via high-resolution respirometry .", "total hemoglobin mass was assessed by carbon monoxide rebreathing .", "skeletal muscle respiratory capacity was not altered by training or hypoxia ; however , electron coupling control respective to fat oxidation slightly diminished with hypoxic training .", "hypoxic training did increase total hemoglobin mass more than the placebo ( @ % vs @ % , p = @ ) .", "in normoxia , hypoxic training had no additive effect on maximal measures of oxygen uptake or time trial performance .", "in acute hypoxia , hypoxic training conferred no advantage on maximal oxygen uptake but tended to enhance time trial performance more than normoxic training ( @ % vs @ % , p = @ ) .", "our data suggest that , in moderately trained subjects , @ wk of hypoxic training possesses no ergogenic effect at sea level .", "it is not excluded that hypoxic training might facilitate endurance capacity at moderate altitude ; however , this issue is still open and needs to be further examined ." ]
the effects of hypoxic training on exercise performance remain controversial . here , we tested the hypotheses that i ) hypoxic training possesses ergogenic effects at sea level and altitude and ii ) the benefits are primarily mediated by improved mitochondrial function of the skeletal muscle . we determined aerobic performance ( incremental test to exhaustion and time trial for a set amount of work ) in moderately trained subjects undergoing @ wk of endurance training ( @-@ times per week , @ min per session ) in normoxia ( placebo , n = @ ) or normobaric hypoxia ( fio@ = @ , n = @ ) using a double-blind and randomized design . exercise tests were performed in normoxia and acute hypoxia ( fio@ = @ ) . skeletal muscle mitochondrial respiratory capacities and electron coupling efficiencies were measured via high-resolution respirometry . total hemoglobin mass was assessed by carbon monoxide rebreathing . skeletal muscle respiratory capacity was not altered by training or hypoxia ; however , electron coupling control respective to fat oxidation slightly diminished with hypoxic training . hypoxic training did increase total hemoglobin mass more than the placebo ( @ % vs @ % , p = @ ) . in normoxia , hypoxic training had no additive effect on maximal measures of oxygen uptake or time trial performance . in acute hypoxia , hypoxic training conferred no advantage on maximal oxygen uptake but tended to enhance time trial performance more than normoxic training ( @ % vs @ % , p = @ ) . our data suggest that , in moderately trained subjects , @ wk of hypoxic training possesses no ergogenic effect at sea level . it is not excluded that hypoxic training might facilitate endurance capacity at moderate altitude ; however , this issue is still open and needs to be further examined .
24,674,976
[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "in this randomized trial , project care , we examined whether participation in a cognitive-behavioral stress management and breast cancer wellness and education program improved psychological outcomes among a sample of underserved black breast cancer survivors .", "both complementary medicine interventions were @-sessions , manualized , group-based , and were culturally adapted for black women in the community from evidence-based interventions .", "participants were @ black women ( mean age = @ , @-@ years ) who had completed breast cancer treatment @-@ months before enrollment ( stages @-iv , mean time since cancer diagnosis = @ months ) .", "women were enrolled upon completion of curative treatment ( ie , surgical , chemotherapy , radiation oncology ) and randomized to receive cognitive-behavioral stress management or cancer wellness and education program .", "there was a remarkable @ % retention rate from baseline to @-month follow-up .", "participants in both conditions showed statistically significant improvement on indices of psychological well-being , including overall quality of life ( functional assessment of cancer therapy-breast ) , intrusive thoughts ( impact of event scale-revised ) , depressive symptoms ( center for epidemiologic studies-depression ) , and stress levels ( perceived stress scale ) over the @-month postintervention follow-up ( all repeated measures analysis of variance within-subjects time effects : p < @ , except for overall mood ; profile of mood states-short version ) .", "contrary to hypotheses , however , condition time effects were not statistically significant .", "findings suggest that improvements in multiple measures over time may have been due to intensive training in stress management , extensive provision of breast cancer information , or participation in an ongoing supportive group of individuals from a similar racial background .", "implications bear on decisions about appropriate control groups , the timing of intervention delivery during the treatment trajectory , and perceived support from the research team ." ]
in this randomized trial , project care , we examined whether participation in a cognitive-behavioral stress management and breast cancer wellness and education program improved psychological outcomes among a sample of underserved black breast cancer survivors . both complementary medicine interventions were @-sessions , manualized , group-based , and were culturally adapted for black women in the community from evidence-based interventions . participants were @ black women ( mean age = @ , @-@ years ) who had completed breast cancer treatment @-@ months before enrollment ( stages @-iv , mean time since cancer diagnosis = @ months ) . women were enrolled upon completion of curative treatment ( ie , surgical , chemotherapy , radiation oncology ) and randomized to receive cognitive-behavioral stress management or cancer wellness and education program . there was a remarkable @ % retention rate from baseline to @-month follow-up . participants in both conditions showed statistically significant improvement on indices of psychological well-being , including overall quality of life ( functional assessment of cancer therapy-breast ) , intrusive thoughts ( impact of event scale-revised ) , depressive symptoms ( center for epidemiologic studies-depression ) , and stress levels ( perceived stress scale ) over the @-month postintervention follow-up ( all repeated measures analysis of variance within-subjects time effects : p < @ , except for overall mood ; profile of mood states-short version ) . contrary to hypotheses , however , condition time effects were not statistically significant . findings suggest that improvements in multiple measures over time may have been due to intensive training in stress management , extensive provision of breast cancer information , or participation in an ongoing supportive group of individuals from a similar racial background . implications bear on decisions about appropriate control groups , the timing of intervention delivery during the treatment trajectory , and perceived support from the research team .
25,749,598
[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "the treatment of acne can be difficult , with suboptimal adherence resulting in poor treatment outcomes .", "to determine whether demonstrating to patients how to properly apply a topical acne medication through the use of a sample product will improve adherence .", "subjects with mild to moderate acne were instructed to use adapalene/benzoyl peroxide gel once daily for six weeks .", "subjects were randomized into sample or no sample group .", "sample group received a demonstration on how to apply the medication using a product sample .", "the primary outcome was median adherence , recorded using electronic monitoring , and secondary outcomes were efficacy measures including the acne global assessment ( aga ) and lesion counts and the perceived medical condition self-management scale ( pmcsms ) .", "data from @ patients was collected and analyzed .", "median adherence rates were @ % in the sample group and @ % in the no sample group ( p = @ ) .", "the median percent improvement in non-inflammatory lesions were @ % for the sample group and @ % for the no-sample group ( p = @ ) .", "the small size of this pilot study limited the extent of subgroup analyses .", "objective electronic monitoring expanded our previous observations of poor adherence in the treatment of acne .", "there is a considerable potential effect size on adherence for the use of samples , supporting the need for future , well powered studies to assess the value of using samples in the treatment of acne and other dermatologic skin diseases ." ]
the treatment of acne can be difficult , with suboptimal adherence resulting in poor treatment outcomes . to determine whether demonstrating to patients how to properly apply a topical acne medication through the use of a sample product will improve adherence . subjects with mild to moderate acne were instructed to use adapalene/benzoyl peroxide gel once daily for six weeks . subjects were randomized into sample or no sample group . sample group received a demonstration on how to apply the medication using a product sample . the primary outcome was median adherence , recorded using electronic monitoring , and secondary outcomes were efficacy measures including the acne global assessment ( aga ) and lesion counts and the perceived medical condition self-management scale ( pmcsms ) . data from @ patients was collected and analyzed . median adherence rates were @ % in the sample group and @ % in the no sample group ( p = @ ) . the median percent improvement in non-inflammatory lesions were @ % for the sample group and @ % for the no-sample group ( p = @ ) . the small size of this pilot study limited the extent of subgroup analyses . objective electronic monitoring expanded our previous observations of poor adherence in the treatment of acne . there is a considerable potential effect size on adherence for the use of samples , supporting the need for future , well powered studies to assess the value of using samples in the treatment of acne and other dermatologic skin diseases .
24,509,962
[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "high blood pressure ( bp ) is commonly not diagnosed , and patients do not achieve target values when treated .", "among @,@ patients encompassing most races-ethnicities , we evaluated bp measurements and treatment response in a stroke prevention trial .", "our goal was to identify bp measurement differences between clinical trial and patient determinations and among the racial-ethnic groups .", "a total of @,@ patients with ischemic stroke were randomized to receive antiplatelet treatment and @ mg of telmisartan versus placebo .", "bp measurements were obtained at the first clinic visit and then @ and @ months later and every @ months thereafter .", "one week after the first clinic visit , patients were requested to report a bp measurement obtained elsewhere .", "measurements at the trial clinics were obtained with the same electronic device .", "statistical analysis was used to detect significant differences .", "the mean patient age was @ years ; @ % were women , and race-ethnicity comprised @ % whites , @ % asian , @ % hispanic , and @ % black .", "overall , @ % of patients were hypertensive .", "bp varied between the race-ethnicity groups , being highest in hispanics ( @/@ ) and lowest in blacks ( @/@ ) .", "bp at visits clinic @ , nonclinic @a , and clinic @ were , respectively , @/@ , @/@ , and @/@ mmhg , with the difference between visits @-@ and visit @a being significant .", "bps were normal in @ % of the cases at visit @a , and of these , only @ % were normal at visit @ and @ % were normal on visit @ .", "similar findings were noted for all race-ethnicity groups .", "bp values varied among race-ethnicities and showed differences between clinic and patient measurements .", "this finding questions the reliability of self-reported bp and has implications for bp management in daily clinical practice ." ]
high blood pressure ( bp ) is commonly not diagnosed , and patients do not achieve target values when treated . among @,@ patients encompassing most races-ethnicities , we evaluated bp measurements and treatment response in a stroke prevention trial . our goal was to identify bp measurement differences between clinical trial and patient determinations and among the racial-ethnic groups . a total of @,@ patients with ischemic stroke were randomized to receive antiplatelet treatment and @ mg of telmisartan versus placebo . bp measurements were obtained at the first clinic visit and then @ and @ months later and every @ months thereafter . one week after the first clinic visit , patients were requested to report a bp measurement obtained elsewhere . measurements at the trial clinics were obtained with the same electronic device . statistical analysis was used to detect significant differences . the mean patient age was @ years ; @ % were women , and race-ethnicity comprised @ % whites , @ % asian , @ % hispanic , and @ % black . overall , @ % of patients were hypertensive . bp varied between the race-ethnicity groups , being highest in hispanics ( @/@ ) and lowest in blacks ( @/@ ) . bp at visits clinic @ , nonclinic @a , and clinic @ were , respectively , @/@ , @/@ , and @/@ mmhg , with the difference between visits @-@ and visit @a being significant . bps were normal in @ % of the cases at visit @a , and of these , only @ % were normal at visit @ and @ % were normal on visit @ . similar findings were noted for all race-ethnicity groups . bp values varied among race-ethnicities and showed differences between clinic and patient measurements . this finding questions the reliability of self-reported bp and has implications for bp management in daily clinical practice .
24,736,279
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to assess the incremental cost and cost-effectiveness of continuous and discontinuous regimens of bevacizumab ( avastin ) and ranibizumab ( lucentis ) for neovascular age-related macular degeneration ( namd ) from a uk national health service ( nhs ) perspective .", "a within-trial cost-utility analysis with a @-year time horizon , based on a multicentre factorial , non-inferiority randomised controlled trial .", "@ hospital ophthalmology clinics .", "@ patients aged @years with untreated namd in the study eye .", "@ mg ranibizumab or @ mg bevacizumab given continuously ( monthly ) or discontinuously ( as-needed ) for @years .", "quality-adjusted life-years ( qalys ) .", "total @-year costs ranged from @/patient ( $ @ ; @ % ci @ to @ ) for discontinuous bevacizumab to @/patient ( $ @ ; @ % ci @ to @ ) for continuous ranibizumab .", "ranibizumab was significantly more costly than bevacizumab for both continuous ( +@ / patient ( $ @ ) ; @ % ci @ to @ ; p < @ ) and discontinuous treatment ( +@ ( $ @ ) ; @ % ci @ to @ ; p < @ ) , with negligible difference in qalys .", "continuous ranibizumab would only be cost-effective compared with continuous bevacizumab if the nhs were willing to pay @ million ( $ @ million ) per additional qaly gained .", "patients receiving continuous bevacizumab accrued higher total costs ( +@ ( $ @ ) ; @ % ci @ to @ ; p = @ ) than those receiving discontinuous bevacizumab , but also accrued non-significantly more qalys ( +@ ; @ % ci -@ to @ ; p = @ ) .", "continuous bevacizumab therefore cost @ ( $ @ ) per qaly gained versus discontinuous bevacizumab .", "however , bootstrapping demonstrated that if the nhs is willing to pay @/qaly gained , there is a @ % chance that continuous bevacizumab is cost-effective versus discontinuous bevacizumab .", "ranibizumab is not cost-effective compared with bevacizumab , being substantially more costly and producing little or no qaly gain .", "discontinuous bevacizumab is likely to be the most cost-effective of the four treatment strategies evaluated in this uk trial , although there is a @ % chance that continuous bevacizumab is cost-effective .", "isrctn@ ." ]
to assess the incremental cost and cost-effectiveness of continuous and discontinuous regimens of bevacizumab ( avastin ) and ranibizumab ( lucentis ) for neovascular age-related macular degeneration ( namd ) from a uk national health service ( nhs ) perspective . a within-trial cost-utility analysis with a @-year time horizon , based on a multicentre factorial , non-inferiority randomised controlled trial . @ hospital ophthalmology clinics . @ patients aged @years with untreated namd in the study eye . @ mg ranibizumab or @ mg bevacizumab given continuously ( monthly ) or discontinuously ( as-needed ) for @years . quality-adjusted life-years ( qalys ) . total @-year costs ranged from @/patient ( $ @ ; @ % ci @ to @ ) for discontinuous bevacizumab to @/patient ( $ @ ; @ % ci @ to @ ) for continuous ranibizumab . ranibizumab was significantly more costly than bevacizumab for both continuous ( +@ / patient ( $ @ ) ; @ % ci @ to @ ; p < @ ) and discontinuous treatment ( +@ ( $ @ ) ; @ % ci @ to @ ; p < @ ) , with negligible difference in qalys . continuous ranibizumab would only be cost-effective compared with continuous bevacizumab if the nhs were willing to pay @ million ( $ @ million ) per additional qaly gained . patients receiving continuous bevacizumab accrued higher total costs ( +@ ( $ @ ) ; @ % ci @ to @ ; p = @ ) than those receiving discontinuous bevacizumab , but also accrued non-significantly more qalys ( +@ ; @ % ci -@ to @ ; p = @ ) . continuous bevacizumab therefore cost @ ( $ @ ) per qaly gained versus discontinuous bevacizumab . however , bootstrapping demonstrated that if the nhs is willing to pay @/qaly gained , there is a @ % chance that continuous bevacizumab is cost-effective versus discontinuous bevacizumab . ranibizumab is not cost-effective compared with bevacizumab , being substantially more costly and producing little or no qaly gain . discontinuous bevacizumab is likely to be the most cost-effective of the four treatment strategies evaluated in this uk trial , although there is a @ % chance that continuous bevacizumab is cost-effective . isrctn@ .
25,079,928
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]
[ "to evaluate two low-dose volumes ( @ ml or @ ml ) of @ % mepivacaine solution used for ultrasound-guided axillary blockade for outpatients undergoing distal upper limb surgery .", "prospective , double-blinded randomized study .", "outpatient surgical setting of a university-affiliated hospital .", "@ adult , asa physical status @ , @ , and @ patients , aged @-@ years , scheduled for upper limb surgery .", "patients were randomized to two groups to receive either @ ml of @ % mepivacaine solution ( n = @ ) or @ ml of @ % mepivacaine solution ( n = @ ) for ultrasound-guided axillary plexus blockade .", "block duration , proportion of surgical and functional successful blocks , onset of sensory and motor blockade measured from @ to @ minutes following final needle extraction , total amount of preoperative sedative ( midazolam ) , and intraoperative propofol administered were recorded .", "following axillary plexus blockade , neither patient group showed any statistically significant difference in the percentage of functionally successful blockade ( @ ml , @ % : @ ml , @ % ; p = @ ) , surgically successful blockade ( @ ml , @ % ; @ ml , @ % ; p = @ ) , cumulative sensory or motor blockade surgical time , block performance time , preoperative midazolam use , or intraoperative propofol use .", "low volumes ( @ ml or @ ml ) of @ % mepivacaine provides satisfactory anesthesia for ambulatory distal upper limb surgery with no significant difference in clinical outcomes ." ]
to evaluate two low-dose volumes ( @ ml or @ ml ) of @ % mepivacaine solution used for ultrasound-guided axillary blockade for outpatients undergoing distal upper limb surgery . prospective , double-blinded randomized study . outpatient surgical setting of a university-affiliated hospital . @ adult , asa physical status @ , @ , and @ patients , aged @-@ years , scheduled for upper limb surgery . patients were randomized to two groups to receive either @ ml of @ % mepivacaine solution ( n = @ ) or @ ml of @ % mepivacaine solution ( n = @ ) for ultrasound-guided axillary plexus blockade . block duration , proportion of surgical and functional successful blocks , onset of sensory and motor blockade measured from @ to @ minutes following final needle extraction , total amount of preoperative sedative ( midazolam ) , and intraoperative propofol administered were recorded . following axillary plexus blockade , neither patient group showed any statistically significant difference in the percentage of functionally successful blockade ( @ ml , @ % : @ ml , @ % ; p = @ ) , surgically successful blockade ( @ ml , @ % ; @ ml , @ % ; p = @ ) , cumulative sensory or motor blockade surgical time , block performance time , preoperative midazolam use , or intraoperative propofol use . low volumes ( @ ml or @ ml ) of @ % mepivacaine provides satisfactory anesthesia for ambulatory distal upper limb surgery with no significant difference in clinical outcomes .
24,793,711
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS" ]
[ "to assess the effect of dimeticone and pepsin on the bioavailability of metoclopramide ( cas @-@-@ ) in healthy volunteers .", "the study was conducted using a randomized , open , @-period crossover design .", "the volunteers received single administration of @-mg conventional metoclopramide capsule and a formulation containing metoclopramide ( @mg ) plus dimeticone ( @mg ) and pepsin ( @mg ) , with a @-day interval between treatments .", "serial blood samples were collected before dosing and during @h post-treatment .", "plasma metoclopramide concentrations were analyzed by liquid chromatography coupled with tandem mass spectrometry ( lc-ms/ms ) .", "the pharmacokinetics parameters auc ( last ) and c ( max ) were obtained from the metoclopramide plasma concentration vs. time curves .", "metoclopramide 's association was bioequivalent to conventional capsule ; @ % cis for geometric mean treatment ratios of c ( max ) -lsb- @ % ( @ % ci , @-@ @ % ) -rsb- , auc ( last ) -lsb- @ % ( @ % ci , @-@ @ % ) -rsb- were within the predefined range .", "the metoclopramide formulations were well tolerated at the administered doses and no significant adverse reactions were observed .", "thus , these results confirm the good bioavailability of metoclopramide in the new formulation and rule out any impaired absorption when the drugs are formulated in combination ." ]
to assess the effect of dimeticone and pepsin on the bioavailability of metoclopramide ( cas @-@-@ ) in healthy volunteers . the study was conducted using a randomized , open , @-period crossover design . the volunteers received single administration of @-mg conventional metoclopramide capsule and a formulation containing metoclopramide ( @mg ) plus dimeticone ( @mg ) and pepsin ( @mg ) , with a @-day interval between treatments . serial blood samples were collected before dosing and during @h post-treatment . plasma metoclopramide concentrations were analyzed by liquid chromatography coupled with tandem mass spectrometry ( lc-ms/ms ) . the pharmacokinetics parameters auc ( last ) and c ( max ) were obtained from the metoclopramide plasma concentration vs. time curves . metoclopramide 's association was bioequivalent to conventional capsule ; @ % cis for geometric mean treatment ratios of c ( max ) -lsb- @ % ( @ % ci , @-@ @ % ) -rsb- , auc ( last ) -lsb- @ % ( @ % ci , @-@ @ % ) -rsb- were within the predefined range . the metoclopramide formulations were well tolerated at the administered doses and no significant adverse reactions were observed . thus , these results confirm the good bioavailability of metoclopramide in the new formulation and rule out any impaired absorption when the drugs are formulated in combination .
24,504,688
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS" ]
[ "esophageal variceal bleed is a major problem in patients with cirrhosis .", "endoscopic variceal ligation ( evl ) has been shown to be equal to or better than propranolol in preventing first bleed .", "carvedilol is a non-selective blocker with alpha-@ adrenergic blocker activity .", "hemodynamic studies have shown carvedilol to be more effective than propranolol at reducing portal pressure .", "we compared efficacy of carvedilol with evl for primary prophylaxis of esophageal variceal bleed .", "cirrhotic patients with esophageal varices were randomized to carvedilol @ mg daily or evl at three university hospitals of pakistan .", "end points were esophageal variceal bleeding , death or liver transplant .", "two hundred and nine patients were evaluated .", "eighty two and eighty six patients were randomized in carvedilol and evl arms respectively .", "mean age was @ @ years ; @ ( @ % ) were males ; @ % had viral cirrhosis ; mean child-pugh score was @ @ and mean follow up was @ @ months ( range @-@ months ) .", "both evl and carvedilol groups had comparable variceal bleeding rates ( @ % vs. @ % ) , bleed related mortality ( @ % vs. @ % ) and overall mortality ( @ % vs. @ % ) respectively .", "adverse events in carvedilol group were hypotension ( n = @ ) , requiring cessation of therapy , while transient nausea ( n = @ ) and dyspnea ( n = @ ) resolved spontaneously .", "in the evl arm , post banding ulcer bleed ( n = @ ) and chest pain ( n = @ ) , were termed as serious adverse events while transient dysphagia ( n = @ ) resolved without treatment .", "although our study is underpowered , the findings suggest that carvedilol is probably not superior to evl in preventing first variceal bleed in patients with viral cirrhosis ." ]
esophageal variceal bleed is a major problem in patients with cirrhosis . endoscopic variceal ligation ( evl ) has been shown to be equal to or better than propranolol in preventing first bleed . carvedilol is a non-selective blocker with alpha-@ adrenergic blocker activity . hemodynamic studies have shown carvedilol to be more effective than propranolol at reducing portal pressure . we compared efficacy of carvedilol with evl for primary prophylaxis of esophageal variceal bleed . cirrhotic patients with esophageal varices were randomized to carvedilol @ mg daily or evl at three university hospitals of pakistan . end points were esophageal variceal bleeding , death or liver transplant . two hundred and nine patients were evaluated . eighty two and eighty six patients were randomized in carvedilol and evl arms respectively . mean age was @ @ years ; @ ( @ % ) were males ; @ % had viral cirrhosis ; mean child-pugh score was @ @ and mean follow up was @ @ months ( range @-@ months ) . both evl and carvedilol groups had comparable variceal bleeding rates ( @ % vs. @ % ) , bleed related mortality ( @ % vs. @ % ) and overall mortality ( @ % vs. @ % ) respectively . adverse events in carvedilol group were hypotension ( n = @ ) , requiring cessation of therapy , while transient nausea ( n = @ ) and dyspnea ( n = @ ) resolved spontaneously . in the evl arm , post banding ulcer bleed ( n = @ ) and chest pain ( n = @ ) , were termed as serious adverse events while transient dysphagia ( n = @ ) resolved without treatment . although our study is underpowered , the findings suggest that carvedilol is probably not superior to evl in preventing first variceal bleed in patients with viral cirrhosis .
24,291,366
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the aim of this study is to systematically investigate under standardized experimental conditions the effects of instrument contamination and wear on the quality of bipolar vessel sealing ( bvs ) achieved using a reusable instrument .", "the study was designed as a prospective , randomized , and controlled in vitro study and conducted in an academic research environment .", "reusable bipolar coagulation forceps ( biclamp @ c , erbe elektromedizin ) were used to apply sealing pressures of @-@ ,@ mn/mm ( @ ) to @ renal arteries from commercially slaughtered female pigs ( swabian-hall swine ) .", "forceps jaws were coated with porcine blood , blood and collagen , or blood , collagen , and fat to simulate instrument contamination with biological material during surgery .", "clinical wear was mimicked by sandpaper abrasion .", "the main outcome measures were seal success ( resistance to @ mmhg intraluminal pressure for @ min ) and seal stability ( burst pressure ) .", "sealing pressure had a significant impact , with @ mn/mm ( @ ) producing the best sealing results .", "seal success increased with total energy applied to the tissue , a higher maximum temperature , and longer coagulation as indicated by desiccation time .", "experimental contamination had no significant impact on seal success and only a limited effect on seal stability .", "similarly , abrasive wear also had no significant effect on either seal quality or seal strength .", "the impact of bipolar forceps contamination and wear on seal success and quality was negligible in our in vitro model .", "to achieve high-quality seals , it is essential to use adequate sealing pressures .", "our findings could have direct implications for the design and clinical handling of bvs instruments ." ]
the aim of this study is to systematically investigate under standardized experimental conditions the effects of instrument contamination and wear on the quality of bipolar vessel sealing ( bvs ) achieved using a reusable instrument . the study was designed as a prospective , randomized , and controlled in vitro study and conducted in an academic research environment . reusable bipolar coagulation forceps ( biclamp @ c , erbe elektromedizin ) were used to apply sealing pressures of @-@ ,@ mn/mm ( @ ) to @ renal arteries from commercially slaughtered female pigs ( swabian-hall swine ) . forceps jaws were coated with porcine blood , blood and collagen , or blood , collagen , and fat to simulate instrument contamination with biological material during surgery . clinical wear was mimicked by sandpaper abrasion . the main outcome measures were seal success ( resistance to @ mmhg intraluminal pressure for @ min ) and seal stability ( burst pressure ) . sealing pressure had a significant impact , with @ mn/mm ( @ ) producing the best sealing results . seal success increased with total energy applied to the tissue , a higher maximum temperature , and longer coagulation as indicated by desiccation time . experimental contamination had no significant impact on seal success and only a limited effect on seal stability . similarly , abrasive wear also had no significant effect on either seal quality or seal strength . the impact of bipolar forceps contamination and wear on seal success and quality was negligible in our in vitro model . to achieve high-quality seals , it is essential to use adequate sealing pressures . our findings could have direct implications for the design and clinical handling of bvs instruments .
25,064,363
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "antispasmodic agents have been used in the management of irritable bowel syndrome .", "however , systematic reviews have come to different conclusions about the efficacy in irritable bowel syndrome .", "fenoverine acts as a synchronizer of smooth muscle in modulating the intracellular influx of calcium .", "we compared fenoverine with trimebutine for the treatment of patients with ibs .", "a multicenter , randomized , double-blind , non-inferiority clinical study was conducted to compared fenoverine with trimebutine .", "subjects were randomized to receive either fenoverine ( @ mg three times a day ) or trimebutine ( @ mg three times a day ) for @ weeks .", "a total of @ patients were analyzed by the intention-to-treat approach .", "the primary endpoint was the proportion of patients who had @ % reduction in abdominal pain or discomfort measured by bowel symptom scale ( bss ) score at week @ compared to the baseline .", "the secondary endpoints were changes of abdominal bloating , diarrhea , constipation , overall and total scores of bss , and overall satisfaction .", "at week @ , fenoverine was shown to be non-inferior to trimebutine ( treatment difference , @ % ; @ % ci , -@ -@ ; p = @ ) ; @ % ( @ of @ patients ) of patients taking fenoverine and @ % ( @ of @ patients ) of patients taking trimebutine showed @ % reduction in abdominal pain or discomfort compared to the baseline .", "there results of the secondary endpoints were also comparable between the fenoverine group and the trimebutine group .", "fenoverine is non-inferior to trimebutine for treating ibs in terms of both efficacy and tolerability ." ]
antispasmodic agents have been used in the management of irritable bowel syndrome . however , systematic reviews have come to different conclusions about the efficacy in irritable bowel syndrome . fenoverine acts as a synchronizer of smooth muscle in modulating the intracellular influx of calcium . we compared fenoverine with trimebutine for the treatment of patients with ibs . a multicenter , randomized , double-blind , non-inferiority clinical study was conducted to compared fenoverine with trimebutine . subjects were randomized to receive either fenoverine ( @ mg three times a day ) or trimebutine ( @ mg three times a day ) for @ weeks . a total of @ patients were analyzed by the intention-to-treat approach . the primary endpoint was the proportion of patients who had @ % reduction in abdominal pain or discomfort measured by bowel symptom scale ( bss ) score at week @ compared to the baseline . the secondary endpoints were changes of abdominal bloating , diarrhea , constipation , overall and total scores of bss , and overall satisfaction . at week @ , fenoverine was shown to be non-inferior to trimebutine ( treatment difference , @ % ; @ % ci , -@ -@ ; p = @ ) ; @ % ( @ of @ patients ) of patients taking fenoverine and @ % ( @ of @ patients ) of patients taking trimebutine showed @ % reduction in abdominal pain or discomfort compared to the baseline . there results of the secondary endpoints were also comparable between the fenoverine group and the trimebutine group . fenoverine is non-inferior to trimebutine for treating ibs in terms of both efficacy and tolerability .
24,262,593
[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "to evaluate , by means of a prospective randomized study , the efficacy of cinacalcet in the forms of nephrolithiasis associated with primary hyperparathyroidism in both the hypercalcemic and normocalcemic variant .", "ten patients suffering from active nephrolithiasis associated with primary hyperparathyroidism ( @ hypercalcemics and @ normocalcemics ) , equally divided between males and females , were randomly but not blindly addressed to treatment with potassium citrate and allopurinol , or to the same therapeutic regimen in combination with cinacalcet .", "the dosage of cinacalcet was optimized for each patient in order to obtain a reduction of parathyroid hormone ( pth ) within normal limits while enabling the maintenance of adequate calcemic values .", "all study participants were given the same diet based on a reduction in sodium intake , oxalate-rich foods and animal protein with standardized intake of calcium and an increase in hydration .", "after a follow up period of @ months , cinacalcet was associated to standard therapy and diet in patients who were not taken it , conversely cinacalcet was withdrawn in the remaining patients who remained on standard therapeutic regimen and diet .", "follow up was continued for a second period of observation of the same duration of the first .", "at the end of the period of treatment with cinacalcet , for both variants of hyperparathyroidism , a statistically significant reduction in the overall number and in the diameter of renal stones was found .", "this prospective randomized study shows the effectiveness of cinacalcet used in combination with a diet with normalized calcium intake , in reducing the number and size of urinary stones in hypercalemic and normocalcemic forms of primary hyperparathyroidism ." ]
to evaluate , by means of a prospective randomized study , the efficacy of cinacalcet in the forms of nephrolithiasis associated with primary hyperparathyroidism in both the hypercalcemic and normocalcemic variant . ten patients suffering from active nephrolithiasis associated with primary hyperparathyroidism ( @ hypercalcemics and @ normocalcemics ) , equally divided between males and females , were randomly but not blindly addressed to treatment with potassium citrate and allopurinol , or to the same therapeutic regimen in combination with cinacalcet . the dosage of cinacalcet was optimized for each patient in order to obtain a reduction of parathyroid hormone ( pth ) within normal limits while enabling the maintenance of adequate calcemic values . all study participants were given the same diet based on a reduction in sodium intake , oxalate-rich foods and animal protein with standardized intake of calcium and an increase in hydration . after a follow up period of @ months , cinacalcet was associated to standard therapy and diet in patients who were not taken it , conversely cinacalcet was withdrawn in the remaining patients who remained on standard therapeutic regimen and diet . follow up was continued for a second period of observation of the same duration of the first . at the end of the period of treatment with cinacalcet , for both variants of hyperparathyroidism , a statistically significant reduction in the overall number and in the diameter of renal stones was found . this prospective randomized study shows the effectiveness of cinacalcet used in combination with a diet with normalized calcium intake , in reducing the number and size of urinary stones in hypercalemic and normocalcemic forms of primary hyperparathyroidism .
25,847,900
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS" ]
[ "levomilnacipran extended-release ( er ) is an fda-approved serotonin norepinephrine reuptake inhibitor ( snri ) for treating major depressive disorder ( mdd ) .", "sf-@v@ health survey outcomes from a phase iii , randomized , double-blind , placebo-controlled study ( nct@ ) were evaluated .", "prospective and post hoc analyses of sf-@ mental and physical component summaries ( mcs , pcs ) , and individual domains compared pooled levomilnacipran er doses ( @ , @ , @ mg/day ) with placebo .", "patients ( @-@ years ) had mdd , depressive episode @ weeks , and montgomery-sberg depression rating scale total score @ .", "sf-@ score changes from baseline to week @ were analyzed using ancova and the observed cases approach ( intent-to-treat -lsb- itt -rsb- population ) .", "minimally important differences ( mid ) evaluated clinical relevance .", "baseline mcs scores reflected marked mental deficits in the itt population ( levomilnacipran er = @ ; placebo = @ ) .", "mcs change at week @ was significantly greater for levomilnacipran er than placebo ( lsmd -lsb- se -rsb- = @ -lsb- @ -rsb- ; p = @ ) ; mid exceeded the @-point threshold .", "baseline pcs scores suggested minimal physical deficits ; no between-group difference at week @ was noted .", "lsmd was nominally statistically significant ( p < @ ) for levomilnacipran er versus placebo in @ domains ( general health -lsb- @ ; p = @ -rsb- , vitality -lsb- @ ; p = @ -rsb- , social functioning -lsb- @ ; p = @ -rsb- , role-emotional -lsb- @ ; p = @ -rsb- , mental health -lsb- @ ; p = @ -rsb- ) ; changes in vitality , social functioning , and mental health exceeded mid .", "the trial was limited by short duration ; analyses were post hoc and adjustments were not made for multiplicity .", "statistically significant and clinically meaningful improvement on the mcs and several individual domains suggest overall and dimensional improvement in health-related functioning for patients with mdd treated with levomilnacipran er versus placebo ." ]
levomilnacipran extended-release ( er ) is an fda-approved serotonin norepinephrine reuptake inhibitor ( snri ) for treating major depressive disorder ( mdd ) . sf-@v@ health survey outcomes from a phase iii , randomized , double-blind , placebo-controlled study ( nct@ ) were evaluated . prospective and post hoc analyses of sf-@ mental and physical component summaries ( mcs , pcs ) , and individual domains compared pooled levomilnacipran er doses ( @ , @ , @ mg/day ) with placebo . patients ( @-@ years ) had mdd , depressive episode @ weeks , and montgomery-sberg depression rating scale total score @ . sf-@ score changes from baseline to week @ were analyzed using ancova and the observed cases approach ( intent-to-treat -lsb- itt -rsb- population ) . minimally important differences ( mid ) evaluated clinical relevance . baseline mcs scores reflected marked mental deficits in the itt population ( levomilnacipran er = @ ; placebo = @ ) . mcs change at week @ was significantly greater for levomilnacipran er than placebo ( lsmd -lsb- se -rsb- = @ -lsb- @ -rsb- ; p = @ ) ; mid exceeded the @-point threshold . baseline pcs scores suggested minimal physical deficits ; no between-group difference at week @ was noted . lsmd was nominally statistically significant ( p < @ ) for levomilnacipran er versus placebo in @ domains ( general health -lsb- @ ; p = @ -rsb- , vitality -lsb- @ ; p = @ -rsb- , social functioning -lsb- @ ; p = @ -rsb- , role-emotional -lsb- @ ; p = @ -rsb- , mental health -lsb- @ ; p = @ -rsb- ) ; changes in vitality , social functioning , and mental health exceeded mid . the trial was limited by short duration ; analyses were post hoc and adjustments were not made for multiplicity . statistically significant and clinically meaningful improvement on the mcs and several individual domains suggest overall and dimensional improvement in health-related functioning for patients with mdd treated with levomilnacipran er versus placebo .
25,259,674
[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to compare best-corrected visual acuity ( bcva ) and central macular thickness ( cmt ) after @-nm subthreshold laser grid photocoagulation and threshold laser grid photocoagulation for the treatment of diabetic macular oedema ( dme ) .", "twenty-three patients ( @ eyes ) with binocular dme were enroled in this study .", "the two eyes of each patient were divided into a subthreshold photocoagulation group and a threshold photocoagulation group .", "the eyes of the subthreshold group underwent @-nm patter scan laser system ( pascal ) @ % end point subthreshold laser grid photocoagulation therapy , whereas the threshold photocoagulation group underwent short-pulse grid photocoagulation with a @-nm pascal system .", "bcva and cmt were assessed in all patients before treatment , @ days after treatment , and @ , @ , and @ months after treatment .", "after grid photocoagulation , the mean bcva improved in both the subthreshold group , and the threshold group , and the two groups did not differ statistically significantly from each other .", "similarly , the macular oedema diminished in both groups after treatment , and the two groups did not differ statistically significantly from each other with regard to cmt .", "both @-nm subthreshold laser grid photocoagulation and threshold laser grid photocoagulation can improve the visual acuity and reduce cmt in dme patients ." ]
to compare best-corrected visual acuity ( bcva ) and central macular thickness ( cmt ) after @-nm subthreshold laser grid photocoagulation and threshold laser grid photocoagulation for the treatment of diabetic macular oedema ( dme ) . twenty-three patients ( @ eyes ) with binocular dme were enroled in this study . the two eyes of each patient were divided into a subthreshold photocoagulation group and a threshold photocoagulation group . the eyes of the subthreshold group underwent @-nm patter scan laser system ( pascal ) @ % end point subthreshold laser grid photocoagulation therapy , whereas the threshold photocoagulation group underwent short-pulse grid photocoagulation with a @-nm pascal system . bcva and cmt were assessed in all patients before treatment , @ days after treatment , and @ , @ , and @ months after treatment . after grid photocoagulation , the mean bcva improved in both the subthreshold group , and the threshold group , and the two groups did not differ statistically significantly from each other . similarly , the macular oedema diminished in both groups after treatment , and the two groups did not differ statistically significantly from each other with regard to cmt . both @-nm subthreshold laser grid photocoagulation and threshold laser grid photocoagulation can improve the visual acuity and reduce cmt in dme patients .
25,697,457
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "the purpose of this study was to investigate the effects of massage therapy compared with occlusal splint therapy on mandibular range of motion ( rom ) in individuals with temporomandibular disorder ( tmd ) and compare the results with rom obtained in a group of individuals without this disorder .", "a blinded randomized clinical trial was conducted .", "twenty-eight volunteers with tmd were randomly distributed into either a massage therapy group or an occlusal splint group .", "both treatments were provided for @ weeks .", "fourteen individuals without tmd were consecutively allocated to a comparison group .", "fonseca anamnestic index was used to characterize tmd and allocate the volunteers to either of the intervention groups or asymptomatic comparison group .", "mandibular rom was evaluated before and after treatment using a digital caliper .", "two-way repeated-measures analysis of variance with a post hoc bonferroni testing was used for intergroup and intragroup comparisons ( level of significance was set to @ % ) .", "cohen d was used to calculate the effect size .", "in the intragroup analysis , significant increases in rom were found for all measures in both the massage and occlusal splint groups ( p < @ ) .", "a small to moderate clinical effect of treatment with the occlusal splint was found regarding right and left lateral excursion in comparison with the massage therapy and asymptomatic comparison groups ( @ < d < @ ) .", "massage therapy on the masticatory muscles and the use of an occlusal splint lead to an increase in mandibular rom similar to that of the asymptomatic comparison group with regard to maximum active mouth opening and both right and left excursion in individuals with tmd ." ]
the purpose of this study was to investigate the effects of massage therapy compared with occlusal splint therapy on mandibular range of motion ( rom ) in individuals with temporomandibular disorder ( tmd ) and compare the results with rom obtained in a group of individuals without this disorder . a blinded randomized clinical trial was conducted . twenty-eight volunteers with tmd were randomly distributed into either a massage therapy group or an occlusal splint group . both treatments were provided for @ weeks . fourteen individuals without tmd were consecutively allocated to a comparison group . fonseca anamnestic index was used to characterize tmd and allocate the volunteers to either of the intervention groups or asymptomatic comparison group . mandibular rom was evaluated before and after treatment using a digital caliper . two-way repeated-measures analysis of variance with a post hoc bonferroni testing was used for intergroup and intragroup comparisons ( level of significance was set to @ % ) . cohen d was used to calculate the effect size . in the intragroup analysis , significant increases in rom were found for all measures in both the massage and occlusal splint groups ( p < @ ) . a small to moderate clinical effect of treatment with the occlusal splint was found regarding right and left lateral excursion in comparison with the massage therapy and asymptomatic comparison groups ( @ < d < @ ) . massage therapy on the masticatory muscles and the use of an occlusal splint lead to an increase in mandibular rom similar to that of the asymptomatic comparison group with regard to maximum active mouth opening and both right and left excursion in individuals with tmd .
24,387,891
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]
[ "evidence exists for the effectiveness of cognitive behaviour therapy for psychosis with moderate effect sizes , but the evidence for cognitive behaviour therapy specifically for distressing voices is less convincing .", "an alternative symptom-based approach may be warranted and a body of literature has explored distressing voices from an interpersonal perspective .", "this literature has informed the development of relating therapy and findings from a case series suggested that this intervention was acceptable to hearers and therapists .", "an external pilot randomized controlled trial ( rct ) comparing outcomes for @ patients receiving @hours ( weekly sessions of one hour ) of relating therapy and their usual treatment with @ patients receiving only their usual treatment .", "participants will be assessed using questionnaires at baseline , @weeks ( post-intervention ) , and @weeks ( follow-up ) .", "expected outcomes will include a refined study protocol and an estimate of the effect size to inform the sample size of a definitive rct .", "if evidence from a fully powered rct suggests that relating therapy is effective , the therapy will extend the range of evidence-based psychological therapies available to people who hear distressing voices .", "current controlled trials isrctn registration number @ .", "registered on @ june @ ." ]
evidence exists for the effectiveness of cognitive behaviour therapy for psychosis with moderate effect sizes , but the evidence for cognitive behaviour therapy specifically for distressing voices is less convincing . an alternative symptom-based approach may be warranted and a body of literature has explored distressing voices from an interpersonal perspective . this literature has informed the development of relating therapy and findings from a case series suggested that this intervention was acceptable to hearers and therapists . an external pilot randomized controlled trial ( rct ) comparing outcomes for @ patients receiving @hours ( weekly sessions of one hour ) of relating therapy and their usual treatment with @ patients receiving only their usual treatment . participants will be assessed using questionnaires at baseline , @weeks ( post-intervention ) , and @weeks ( follow-up ) . expected outcomes will include a refined study protocol and an estimate of the effect size to inform the sample size of a definitive rct . if evidence from a fully powered rct suggests that relating therapy is effective , the therapy will extend the range of evidence-based psychological therapies available to people who hear distressing voices . current controlled trials isrctn registration number @ . registered on @ june @ .
25,128,004
[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND" ]
[ "to identify genetic markers capable of predicting the pharmacokinetics , pharmacodynamics , and adverse effects of risperidone .", "genotyping was performed in @ healthy volunteers receiving a single @mg oral dose of risperidone .", "risperidone and hydroxyrisperidone plasma levels were measured using high-performance liquid chromatography combined with tandem mass spectrometry.prolactin concentration was quantified by direct chemiluminescence .", "poor cyp@d@ metabolizers showed higher risperidone cmax , area under the curve ( auc ) , and t@/@ , as well as lower clearance .", "they also showed lower cmax and auc and higher t@/@ for hydroxyrisperidone .", "furthermore , individuals with a mutant vkorc@ genotype had a lower risperidone auc and t@/@ and higher clearance .", "the hydroxyrisperidone auc was lower in individuals with the comt mutant genotype .", "risperidone increased prolactin levels ( iauc and icmax ) , which were higher in women than in men .", "the most frequent reactions were somnolence ( @ % ) , headache ( @ % ) , and dizziness ( @ % ) .", "women had neurological effects and headache more frequently than men .", "the incidence of headache was associated with polymorphisms in the agtr@ and nat@ ; neurological effects were associated with cyp@c@ .", "differences in the pharmacokinetics of risperidone are due to polymorphisms in cyp@d@ , comt , and vkorc@ .", "differences in adverse reactions can be explained by gender and polymorphisms in cyp@c@ , agtr@ , and nat@ ." ]
to identify genetic markers capable of predicting the pharmacokinetics , pharmacodynamics , and adverse effects of risperidone . genotyping was performed in @ healthy volunteers receiving a single @mg oral dose of risperidone . risperidone and hydroxyrisperidone plasma levels were measured using high-performance liquid chromatography combined with tandem mass spectrometry.prolactin concentration was quantified by direct chemiluminescence . poor cyp@d@ metabolizers showed higher risperidone cmax , area under the curve ( auc ) , and t@/@ , as well as lower clearance . they also showed lower cmax and auc and higher t@/@ for hydroxyrisperidone . furthermore , individuals with a mutant vkorc@ genotype had a lower risperidone auc and t@/@ and higher clearance . the hydroxyrisperidone auc was lower in individuals with the comt mutant genotype . risperidone increased prolactin levels ( iauc and icmax ) , which were higher in women than in men . the most frequent reactions were somnolence ( @ % ) , headache ( @ % ) , and dizziness ( @ % ) . women had neurological effects and headache more frequently than men . the incidence of headache was associated with polymorphisms in the agtr@ and nat@ ; neurological effects were associated with cyp@c@ . differences in the pharmacokinetics of risperidone are due to polymorphisms in cyp@d@ , comt , and vkorc@ . differences in adverse reactions can be explained by gender and polymorphisms in cyp@c@ , agtr@ , and nat@ .
25,042,870
[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]
[ "to investigate the clinical efficacy of x-ray imaging combined with skin stimulation potential-guided percutaneous radiofrequency thermocoagulation of the gasserian ganglion for treatment of primary trigeminal neuralgia .", "this is a prospective , randomized study .", "sixty patients with primary trigeminal neuralgia were randomly assigned to a study group or control group .", "in the study group , the patients underwent x-ray imaging combined with skin stimulation potential-guided percutaneous radiofrequency thermocoagulation of the gasserian ganglion .", "the patients in the control group underwent c-arm x-ray-guided puncture through the foramen ovale , and then the puncture needle was microscopically adjusted according to the intensity of the masticatory muscle response and the patients ' reactions .", "puncture success , postoperative adverse reactions , and short - and middle-term analgesic efficacies were statistically compared between the two surgical approaches .", "the incidence of postoperative side effects was significantly reduced , and immediate and mid-term analgesic efficacy was better in patients in the study group comparing with those in the control group ( p < @ ) .", "using skin stimulation potential-guided puncture may enable more accurate microscopic adjustment of the targets localization damaged by radiofrequency and significantly enhanced clinical efficacy in this study ." ]
to investigate the clinical efficacy of x-ray imaging combined with skin stimulation potential-guided percutaneous radiofrequency thermocoagulation of the gasserian ganglion for treatment of primary trigeminal neuralgia . this is a prospective , randomized study . sixty patients with primary trigeminal neuralgia were randomly assigned to a study group or control group . in the study group , the patients underwent x-ray imaging combined with skin stimulation potential-guided percutaneous radiofrequency thermocoagulation of the gasserian ganglion . the patients in the control group underwent c-arm x-ray-guided puncture through the foramen ovale , and then the puncture needle was microscopically adjusted according to the intensity of the masticatory muscle response and the patients ' reactions . puncture success , postoperative adverse reactions , and short - and middle-term analgesic efficacies were statistically compared between the two surgical approaches . the incidence of postoperative side effects was significantly reduced , and immediate and mid-term analgesic efficacy was better in patients in the study group comparing with those in the control group ( p < @ ) . using skin stimulation potential-guided puncture may enable more accurate microscopic adjustment of the targets localization damaged by radiofrequency and significantly enhanced clinical efficacy in this study .
24,506,258
[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS" ]
[ "to assess pregabalin monotherapy for partial-onset seizures using a historical-controlled conversion-to-monotherapy design .", "adults with inadequately controlled partial-onset seizures while receiving @ or @ antiepileptic drugs during an @-week prospective baseline were randomized to double-blind monotherapy with pregabalin @ or @ mg/d ( @:@ ) for @ weeks ( @-week conversion and @-week monotherapy period ) .", "the primary endpoint was the seizure-related exit rate for pregabalin @ mg/d , based on discontinuations due to predefined criteria .", "efficacy was declared if the upper limit of the @ % confidence interval for the exit rate was below a historical-control threshold of @ % , with stepwise evaluation using a threshold of @ % .", "the trial was stopped early for positive efficacy after an interim analysis in @ patients .", "the full study population included @ patients , with @ evaluable for efficacy .", "the mean time since epilepsy diagnosis was @ years .", "overall , @ % ( @ mg/d ) and @ % ( @ mg/d ) of patients completed @ weeks of double-blind treatment .", "seizure-related exit rate in the @ mg/d group ( @ % ; @ % confidence interval , @ % -@ % ) was significantly below the @ % and @ % thresholds ( p < @ for both ) .", "eight patients on @ mg/d and @ on @ mg/d were seizure-free throughout pregabalin monotherapy .", "pregabalin 's overall safety profile was consistent with prior trials .", "pregabalin monotherapy was safe and efficacious for patients with inadequately controlled partial-onset seizures .", "this study provides class iii evidence that patients with inadequately controlled partial-onset seizures switched to pregabalin monotherapy have fewer seizure-related exit events compared with historical controls switched to pseudo-placebo monotherapy ." ]
to assess pregabalin monotherapy for partial-onset seizures using a historical-controlled conversion-to-monotherapy design . adults with inadequately controlled partial-onset seizures while receiving @ or @ antiepileptic drugs during an @-week prospective baseline were randomized to double-blind monotherapy with pregabalin @ or @ mg/d ( @:@ ) for @ weeks ( @-week conversion and @-week monotherapy period ) . the primary endpoint was the seizure-related exit rate for pregabalin @ mg/d , based on discontinuations due to predefined criteria . efficacy was declared if the upper limit of the @ % confidence interval for the exit rate was below a historical-control threshold of @ % , with stepwise evaluation using a threshold of @ % . the trial was stopped early for positive efficacy after an interim analysis in @ patients . the full study population included @ patients , with @ evaluable for efficacy . the mean time since epilepsy diagnosis was @ years . overall , @ % ( @ mg/d ) and @ % ( @ mg/d ) of patients completed @ weeks of double-blind treatment . seizure-related exit rate in the @ mg/d group ( @ % ; @ % confidence interval , @ % -@ % ) was significantly below the @ % and @ % thresholds ( p < @ for both ) . eight patients on @ mg/d and @ on @ mg/d were seizure-free throughout pregabalin monotherapy . pregabalin 's overall safety profile was consistent with prior trials . pregabalin monotherapy was safe and efficacious for patients with inadequately controlled partial-onset seizures . this study provides class iii evidence that patients with inadequately controlled partial-onset seizures switched to pregabalin monotherapy have fewer seizure-related exit events compared with historical controls switched to pseudo-placebo monotherapy .
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[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "METHODS" ]