AdaptLLM/RCT · Datasets at Hugging Face

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METHODS	The primary outcomes were a clinician 's decision to undertake further intervention to control bleeding , and the difference between preoperative and postoperative hemoglobin levels .
RESULTS	Although fewer women in the intervention group required additional measures to achieve hemostasis during CD , the difference between the groups was not significant ( relative risk 0.54 ; 95 % confidence interval , 0.19-1 .57 ) .
RESULTS	The change in hemoglobin level among women in the intervention arm was also similar to that among controls ( 2.3 g/dL ; 95 % confidence interval , -4.4 to 8.9 ) .
CONCLUSIONS	The prophylactic use of a Bakri balloon at CD for placenta previa tended to be of benefit , with no evidence of harm or patient dissatisfaction , but the need for additional medical/surgical measures to control blood loss was not significantly reduced .
CONCLUSIONS	Australian New Zealand Clinical Trials Registry : ACTRN12613000348752 .
BACKGROUND	Exercise training is recommended for chronic heart failure ( HF ) patients to improve functional status and reduce risk of adverse outcomes .
BACKGROUND	Elevated plasma levels of amino-terminal pro-brain natriuretic peptide ( NT-proBNP ) , high-sensitivity C-reactive protein ( hs-CRP ) , and cardiac troponin T ( cTnT ) are associated with increased risk of adverse outcomes in this patient population .
BACKGROUND	Whether exercise training leads to improvements in biomarkers and how such improvements relate to clinical outcomes are unclear .
RESULTS	Amino-terminal pro-brain natriuretic peptide , hs-CRP , and cTnT levels were assessed at baseline and 3 months in a cohort of 928 subjects from the HF-ACTION study , a randomized clinical trial of exercise training versus usual care in chronic HF patients with reduced left ventricular ejection fraction ( < 35 % ) .
RESULTS	Linear and logistic regressions were used to assess 3-month biomarker levels as a function of baseline value , treatment assignment ( exercise training vs usual care ) , and volume of exercise .
RESULTS	Linear regression and Cox proportional hazard modeling were used to evaluate the relations between changes in biomarker levels and clinical outcomes of interest that included change in peak oxygen consumption ( peak VO2 ) , hospitalizations , and mortality .
RESULTS	Exercise training was not associated with significant changes in levels of NT-proBNP ( P = .10 ) , hs-CRP ( P = .80 ) , or detectable cTnT levels ( P = .83 ) at 3 months .
RESULTS	Controlling for baseline biomarker levels or volume of exercise did not alter these findings .
RESULTS	Decreases in plasma concentrations of NT-proBNP , but not hs-CRP or cTnT , were associated with increases in peak VO2 ( P < .001 ) at 3 months and decreased risk of hospitalizations or mortality ( P .04 ) , even after adjustment for a comprehensive set of known predictors .
CONCLUSIONS	Exercise training did not lead to meaningful changes in biomarkers of myocardial stress , inflammation , or necrosis in patients with chronic HF .
CONCLUSIONS	Only improvements in NT-proBNP translated to reductions in peak VO2 and reduced risk of clinical events .
BACKGROUND	Biofortification is a strategy to relieve vitamin A ( VA ) deficiency .
BACKGROUND	Biofortified maize contains enhanced provitamin A concentrations and has been bioefficacious in animal and small human studies .
OBJECTIVE	The study sought to determine changes in total body reserves ( TBRs ) of vitamin A with consumption of biofortified maize .
METHODS	A randomized , placebo-controlled biofortified maize efficacy trial was conducted in 140 rural Zambian children .
METHODS	The paired ( 13 ) C-retinol isotope dilution test , a sensitive biomarker for VA status , was used to measure TBRs before and after a 90-d intervention .
METHODS	Treatments were white maize with placebo oil ( VA - ) , orange maize with placebo ( orange ) , and white maize with VA in oil [ 400 g retinol activity equivalents ( RAEs ) in 214 L daily ] ( VA + ) .
RESULTS	In total , 133 children completed the trial and were analyzed for TBRs ( n = 44 or 45/group ) .
RESULTS	Change in TBR residuals were not normally distributed ( P < 0.0001 ) ; median changes ( 95 % CI ) were as follows : VA - , 13 ( -19 , 44 ) mol ; orange , 84 ( 21 , 146 ) mol ; and VA + , 98 ( 24 , 171 ) mol .
RESULTS	Nonparametric analysis showed no statistical difference between VA + and orange ( P = 0.34 ) ; both were higher than VA - ( P = 0.0034 ) .
RESULTS	Median ( 95 % CI ) calculated liver reserves at baseline were 1.04 ( 0.97 , 1.12 ) mol/g liver , with 59 % > 1 mol/g , the subtoxicity cutoff ; none were < 0.1 mol/g , the deficiency cutoff .
RESULTS	The calculated bioconversion factor was 10.4 g - carotene equivalents/1 g retinol by using the middle 3 quintiles of change in TBRs from each group .
RESULTS	Serum retinol did not change in response to intervention ( P = 0.16 ) but was reduced with elevated C-reactive protein ( P = 0.0029 ) and -1 - acid glycoprotein ( P = 0.0023 ) at baseline .
CONCLUSIONS	- Carotene from maize was efficacious when consumed as a staple food in this population and could avoid the potential for hypervitaminosis A that was observed with the use of preformed VA from supplementation and fortification .
CONCLUSIONS	Use of more sensitive methods other than serum retinol alone , such as isotope dilution , is required to accurately assess VA status , evaluate interventions , and investigate the interaction of VA status and infection .
CONCLUSIONS	This trial was registered at clinicaltrials.gov as NCT01814891 .
BACKGROUND	Submassive pulmonary embolism ( PE ) has a low mortality rate but can degrade functional capacity .
OBJECTIVE	The present study aims to provide rationale , methodology , and initial findings of a multicentre , randomised trial of fibrinolysis for PE that used a composite end-point , including quality of life measures .
METHODS	This investigator-initiated study was funded by a contract between a corporate partner and the investigator 's hospital ( the prime site ) .
METHODS	The investigator was the Food and Drug Administration ( FDA ) sponsor .
METHODS	The prime site subcontracted , indemnified , and trained consortia members .
METHODS	Consenting , normotensive patients with PE and right ventricular strain ( by echocardiography or biomarkers ) received low-molecular-weight heparin and random assignment to a single bolus of tenecteplase or placebo in double-blinded fashion .
METHODS	The outcomes were : ( i ) in-hospital rate of intubation , vasopressor support , and major haemorrhage , or ( ii ) at 90 days , death , recurrent PE , or composite that defined poor quality of life ( echocardiography , 6 min walk test and surveys ) .
METHODS	The planned sample size was n = 200 .
RESULTS	Eight sites enrolled 87 patients over 5 years .
RESULTS	The ratio of patients screened for each enrolled was 7.4 to 1 , equating to 11 h screening time per patient enrolled .
RESULTS	Primary barrier to enrolment was the cost of screening .
RESULTS	Two patients died ( 2.5 % , 95 % CI [ 0-8 % ] ) , one developed shock , but 18 ( 22 % , 95 % CI : [ 13-30 % ] ) had a poor quality of life .
CONCLUSIONS	An investigator-initiated , FDA-regulated , multicentre trial of fibrinolysis for submassive PE was conducted , but was limited by screening costs and a low mortality rate .
CONCLUSIONS	Quality of life measurements might represent a more important patient-centred end-point .
BACKGROUND	Crashes are the leading cause of death for teens , and parent-based interventions are a promising approach .
BACKGROUND	We assess the effectiveness of Steering Teens Safe , a parent-focused program to increase safe teen driving .
METHODS	Steering Teens Safe aimed to improve parental communication with teens about safe driving using motivational interviewing techniques in conjunction with 19 safe driving lessons .
METHODS	A randomized controlled trial involved 145 parent-teen dyads ( 70 intervention and 75 control ) .
METHODS	Intervention parents received a 45-minute session to learn the program with four follow-up phone sessions , a DVD , and a workbook .
METHODS	Control parents received a standard brochure about safe driving .
METHODS	Scores were developed to measure teen-reported quantity and quality of parental communication about safe driving .
METHODS	The main outcome measure was a previously validated Risky Driving Score reported by teens .
METHODS	Because the Score was highly skewed , a generalized linear model based on a gamma distribution was used for analysis .
RESULTS	Intervention teens ranked their parent 's success in talking about driving safety higher than control teens ( p = 0.035 ) and reported that their parents talked about more topics ( non-significant difference ) .
RESULTS	The Risky Driving Score was 21 % lower in intervention compared to control teens ( 85 % CI = 0.60 , 1.00 ) .
RESULTS	Interaction between communication quantity and the intervention was examined .
RESULTS	Intervention teens who reported more successful communication had a 42 % lower Risky Driving Score ( 95 % CI = 0.37 , 0.94 ) than control parents with less successful communication .
CONCLUSIONS	This program had a positive although not strong effect , and it may hold the most promise in partnership with other programs , such as Driver 's Education or Graduated Driver 's License policies .
BACKGROUND	ClinicalTrials.gov NCT01014923 .
BACKGROUND	Registered Nov. 16 , 2009 .
OBJECTIVE	Deep molecular response ( MR ( 4.5 ) ) defines a subgroup of patients with chronic myeloid leukemia ( CML ) who may stay in unmaintained remission after treatment discontinuation .
OBJECTIVE	It is unclear how many patients achieve MR ( 4.5 ) under different treatment modalities and whether MR ( 4.5 ) predicts survival .
METHODS	Patients from the randomized CML-Study IV were analyzed for confirmed MR ( 4.5 ) which was defined as 4.5 log reduction of BCR-ABL on the international scale ( IS ) and determined by reverse transcriptase polymerase chain reaction in two consecutive analyses .
METHODS	Landmark analyses were performed to assess the impact of MR ( 4.5 ) on survival .
RESULTS	Of 1,551 randomly assigned patients , 1,524 were assessable .
RESULTS	After a median observation time of 67.5 months , 5-year overall survival ( OS ) was 90 % , 5-year progression-free-survival was 87.5 % , and 8-year OS was 86 % .
RESULTS	The cumulative incidence of MR ( 4.5 ) after 9 years was 70 % ( median , 4.9 years ) ; confirmed MR ( 4.5 ) was 54 % .
RESULTS	MR ( 4.5 ) was reached more quickly with optimized high-dose imatinib than with imatinib 400 mg/day ( P = .016 ) .
RESULTS	Independent of treatment approach , confirmed MR ( 4.5 ) at 4 years predicted significantly higher survival probabilities than 0.1 % to 1 % IS , which corresponds to complete cytogenetic remission ( 8-year OS , 92 % v 83 % ; P = .047 ) .
RESULTS	High-dose imatinib and early major molecular remission predicted MR ( 4.5 ) .
RESULTS	No patient with confirmed MR ( 4.5 ) has experienced progression .
CONCLUSIONS	MR ( 4.5 ) is a new molecular predictor of long-term outcome , is reached by a majority of patients treated with imatinib , and is achieved more quickly with optimized high-dose imatinib , which may provide an improved therapeutic basis for treatment discontinuation in CML .
OBJECTIVE	To compare the efficacy and safety of endoscopic dacryocystorhinostomy ( En-DCR ) with different stent materials for lacrimal sac intubation in primary nasolacrimal ductal obstructions .
METHODS	Randomized controlled study with three parallel groups .
METHODS	Level of evidence is 1b .
METHODS	A total of 91 patients ( five bilateral ) with primary nasolacrimal duct obstruction ( NLDO ) at a tertiary referral center scheduled for En-DCR were to allocated into three stent groups with a sealed envelope and were randomized into three treatments : silicone , Prolene ( polypropylene ) , and otologic T-tube .
METHODS	Ophthalmology and otolaryngology clinics evaluated the patients preoperatively and postoperatively with endoscopes , lacrimal system syringing , and dacryocystography .
METHODS	The success of the stents was evaluated 12 months after surgery with symptom relief and ostial patency .
METHODS	Complications were also noted .
RESULTS	The overall success rate of the En-DCR in the stent groups was 78.1 % ( 75/96 ) ; specifically , 87.5 % ( 28/32 ) with silicone , 84.4 % ( 27/32 ) with Prolene , and 62.5 % ( 20/32 ) with T-tube .
RESULTS	The efficacy of the procedures with the T-tube was significantly lower than that of the Prolene and silicone ( p = .031 , ( 2 ) test ) .
RESULTS	There were no significant differences between the silicone and Prolene ( p = .718 , ( 2 ) test ) .
RESULTS	Prolene was found to be related with orbital complications .
RESULTS	Spontaneous loss is a particular complication of otologic T-tube and highly portends to failure .
CONCLUSIONS	The results of our study suggest that efficacy , defined as anatomic and functional success , is equally high for silicone and Prolene stents and lower for otologic T-tube in En-DCR .
BACKGROUND	Little is known about the longer-term effects of adjunctive benzodiazepines on symptom response during treatment in patients with bipolar disorders .
METHODS	The study sample consisted of 482 patients with bipolar I or II disorder enrolled in a 6-month , randomized , multi-site comparison of lithium - and quetiapine-based treatment .
METHODS	Changes in clinical measures ( BISS total and subscales , CGI-BP , and CGI-Efficacy Index ) were compared between participants who did and did not receive benzodiazepine treatment at baseline or during follow-up .
METHODS	Selected outcomes were also compared between patients who did and did not initiate benzodiazepines during follow-up using stabilized inverse probability weighted analyses .
RESULTS	Significant improvement in all outcome measures occurred within each benzodiazepine exposure group .
RESULTS	Benzodiazepine users ( at baseline or during follow-up ) experienced significantly less improvement in BISS total , BISS irritability , and CGI-BP scores than did benzodiazepine non-users .
RESULTS	There were no significant differences in these measures between patients who did and did not initiate benzodiazepines during follow-up in the weighted analyses .
RESULTS	There was no significant effect of benzodiazepine use on any outcome measure in patients with comorbid anxiety or substance use disorders .
CONCLUSIONS	This is a secondary analysis of data from a randomized effectiveness trial that was not designed to address differential treatment response according to benzodiazepine use .
CONCLUSIONS	Adjunctive benzodiazepines may not significantly affect clinical outcome in lithium - or quetiapine-treated patients with bipolar I or II disorder over 6 months , after controlling for potential confounding factors .
BACKGROUND	Most patients with diabetic kidney disease ( DKD ) experience disease progression despite receiving standard care therapy .
BACKGROUND	Oxidative stress is associated with DKD severity and risk of progression , but currently approved therapies do not directly attenuate the pathologic consequences of oxidative stress .
BACKGROUND	GS-4997 is a once daily , oral molecule that inhibits Apoptosis Signal-regulating Kinase 1 ( ASK1 ) , which is a key mediator of the deleterious effects of oxidative stress .
METHODS	We describe the rationale and design of a Phase 2 placebo-controlled clinical trial investigating the effects of GS-4997 in patients with T2DM and stage 3/4 DKD receiving standard of care therapy .

METHODS

The primary outcomes were a clinician 's decision to undertake further intervention to control bleeding , and the difference between preoperative and postoperative hemoglobin levels .

RESULTS

Although fewer women in the intervention group required additional measures to achieve hemostasis during CD , the difference between the groups was not significant ( relative risk 0.54 ; 95 % confidence interval , 0.19-1 .57 ) .

RESULTS

The change in hemoglobin level among women in the intervention arm was also similar to that among controls ( 2.3 g/dL ; 95 % confidence interval , -4.4 to 8.9 ) .

CONCLUSIONS

The prophylactic use of a Bakri balloon at CD for placenta previa tended to be of benefit , with no evidence of harm or patient dissatisfaction , but the need for additional medical/surgical measures to control blood loss was not significantly reduced .

CONCLUSIONS

Australian New Zealand Clinical Trials Registry : ACTRN12613000348752 .

BACKGROUND

Exercise training is recommended for chronic heart failure ( HF ) patients to improve functional status and reduce risk of adverse outcomes .

BACKGROUND

Elevated plasma levels of amino-terminal pro-brain natriuretic peptide ( NT-proBNP ) , high-sensitivity C-reactive protein ( hs-CRP ) , and cardiac troponin T ( cTnT ) are associated with increased risk of adverse outcomes in this patient population .

BACKGROUND

Whether exercise training leads to improvements in biomarkers and how such improvements relate to clinical outcomes are unclear .

RESULTS

Amino-terminal pro-brain natriuretic peptide , hs-CRP , and cTnT levels were assessed at baseline and 3 months in a cohort of 928 subjects from the HF-ACTION study , a randomized clinical trial of exercise training versus usual care in chronic HF patients with reduced left ventricular ejection fraction ( < 35 % ) .

RESULTS

Linear and logistic regressions were used to assess 3-month biomarker levels as a function of baseline value , treatment assignment ( exercise training vs usual care ) , and volume of exercise .

RESULTS

Linear regression and Cox proportional hazard modeling were used to evaluate the relations between changes in biomarker levels and clinical outcomes of interest that included change in peak oxygen consumption ( peak VO2 ) , hospitalizations , and mortality .

RESULTS

Exercise training was not associated with significant changes in levels of NT-proBNP ( P = .10 ) , hs-CRP ( P = .80 ) , or detectable cTnT levels ( P = .83 ) at 3 months .

RESULTS

Controlling for baseline biomarker levels or volume of exercise did not alter these findings .

RESULTS

Decreases in plasma concentrations of NT-proBNP , but not hs-CRP or cTnT , were associated with increases in peak VO2 ( P < .001 ) at 3 months and decreased risk of hospitalizations or mortality ( P .04 ) , even after adjustment for a comprehensive set of known predictors .

CONCLUSIONS

Exercise training did not lead to meaningful changes in biomarkers of myocardial stress , inflammation , or necrosis in patients with chronic HF .

CONCLUSIONS

Only improvements in NT-proBNP translated to reductions in peak VO2 and reduced risk of clinical events .

BACKGROUND

Biofortification is a strategy to relieve vitamin A ( VA ) deficiency .

BACKGROUND

Biofortified maize contains enhanced provitamin A concentrations and has been bioefficacious in animal and small human studies .

OBJECTIVE

The study sought to determine changes in total body reserves ( TBRs ) of vitamin A with consumption of biofortified maize .

METHODS

A randomized , placebo-controlled biofortified maize efficacy trial was conducted in 140 rural Zambian children .

METHODS

The paired ( 13 ) C-retinol isotope dilution test , a sensitive biomarker for VA status , was used to measure TBRs before and after a 90-d intervention .

METHODS

Treatments were white maize with placebo oil ( VA - ) , orange maize with placebo ( orange ) , and white maize with VA in oil [ 400 g retinol activity equivalents ( RAEs ) in 214 L daily ] ( VA + ) .

RESULTS

In total , 133 children completed the trial and were analyzed for TBRs ( n = 44 or 45/group ) .

RESULTS

Change in TBR residuals were not normally distributed ( P < 0.0001 ) ; median changes ( 95 % CI ) were as follows : VA - , 13 ( -19 , 44 ) mol ; orange , 84 ( 21 , 146 ) mol ; and VA + , 98 ( 24 , 171 ) mol .

RESULTS

Nonparametric analysis showed no statistical difference between VA + and orange ( P = 0.34 ) ; both were higher than VA - ( P = 0.0034 ) .

RESULTS

Median ( 95 % CI ) calculated liver reserves at baseline were 1.04 ( 0.97 , 1.12 ) mol/g liver , with 59 % > 1 mol/g , the subtoxicity cutoff ; none were < 0.1 mol/g , the deficiency cutoff .

RESULTS

The calculated bioconversion factor was 10.4 g - carotene equivalents/1 g retinol by using the middle 3 quintiles of change in TBRs from each group .

RESULTS

Serum retinol did not change in response to intervention ( P = 0.16 ) but was reduced with elevated C-reactive protein ( P = 0.0029 ) and -1 - acid glycoprotein ( P = 0.0023 ) at baseline .

CONCLUSIONS

- Carotene from maize was efficacious when consumed as a staple food in this population and could avoid the potential for hypervitaminosis A that was observed with the use of preformed VA from supplementation and fortification .

CONCLUSIONS

Use of more sensitive methods other than serum retinol alone , such as isotope dilution , is required to accurately assess VA status , evaluate interventions , and investigate the interaction of VA status and infection .

CONCLUSIONS

This trial was registered at clinicaltrials.gov as NCT01814891 .

BACKGROUND

Submassive pulmonary embolism ( PE ) has a low mortality rate but can degrade functional capacity .

OBJECTIVE

The present study aims to provide rationale , methodology , and initial findings of a multicentre , randomised trial of fibrinolysis for PE that used a composite end-point , including quality of life measures .

METHODS

This investigator-initiated study was funded by a contract between a corporate partner and the investigator 's hospital ( the prime site ) .

METHODS

The investigator was the Food and Drug Administration ( FDA ) sponsor .

METHODS

The prime site subcontracted , indemnified , and trained consortia members .

METHODS

Consenting , normotensive patients with PE and right ventricular strain ( by echocardiography or biomarkers ) received low-molecular-weight heparin and random assignment to a single bolus of tenecteplase or placebo in double-blinded fashion .

METHODS

The outcomes were : ( i ) in-hospital rate of intubation , vasopressor support , and major haemorrhage , or ( ii ) at 90 days , death , recurrent PE , or composite that defined poor quality of life ( echocardiography , 6 min walk test and surveys ) .

METHODS

The planned sample size was n = 200 .

RESULTS

Eight sites enrolled 87 patients over 5 years .

RESULTS

The ratio of patients screened for each enrolled was 7.4 to 1 , equating to 11 h screening time per patient enrolled .

RESULTS

Primary barrier to enrolment was the cost of screening .

RESULTS

Two patients died ( 2.5 % , 95 % CI [ 0-8 % ] ) , one developed shock , but 18 ( 22 % , 95 % CI : [ 13-30 % ] ) had a poor quality of life .

CONCLUSIONS

An investigator-initiated , FDA-regulated , multicentre trial of fibrinolysis for submassive PE was conducted , but was limited by screening costs and a low mortality rate .

CONCLUSIONS

Quality of life measurements might represent a more important patient-centred end-point .

BACKGROUND

Crashes are the leading cause of death for teens , and parent-based interventions are a promising approach .

BACKGROUND

We assess the effectiveness of Steering Teens Safe , a parent-focused program to increase safe teen driving .

METHODS

Steering Teens Safe aimed to improve parental communication with teens about safe driving using motivational interviewing techniques in conjunction with 19 safe driving lessons .

METHODS

A randomized controlled trial involved 145 parent-teen dyads ( 70 intervention and 75 control ) .

METHODS

Intervention parents received a 45-minute session to learn the program with four follow-up phone sessions , a DVD , and a workbook .

METHODS

Control parents received a standard brochure about safe driving .

METHODS

Scores were developed to measure teen-reported quantity and quality of parental communication about safe driving .

METHODS

The main outcome measure was a previously validated Risky Driving Score reported by teens .

METHODS

Because the Score was highly skewed , a generalized linear model based on a gamma distribution was used for analysis .

RESULTS

Intervention teens ranked their parent 's success in talking about driving safety higher than control teens ( p = 0.035 ) and reported that their parents talked about more topics ( non-significant difference ) .

RESULTS

The Risky Driving Score was 21 % lower in intervention compared to control teens ( 85 % CI = 0.60 , 1.00 ) .

RESULTS

Interaction between communication quantity and the intervention was examined .

RESULTS

Intervention teens who reported more successful communication had a 42 % lower Risky Driving Score ( 95 % CI = 0.37 , 0.94 ) than control parents with less successful communication .

CONCLUSIONS

This program had a positive although not strong effect , and it may hold the most promise in partnership with other programs , such as Driver 's Education or Graduated Driver 's License policies .

BACKGROUND

ClinicalTrials.gov NCT01014923 .

BACKGROUND

Registered Nov. 16 , 2009 .

OBJECTIVE

Deep molecular response ( MR ( 4.5 ) ) defines a subgroup of patients with chronic myeloid leukemia ( CML ) who may stay in unmaintained remission after treatment discontinuation .

OBJECTIVE

It is unclear how many patients achieve MR ( 4.5 ) under different treatment modalities and whether MR ( 4.5 ) predicts survival .

METHODS

Patients from the randomized CML-Study IV were analyzed for confirmed MR ( 4.5 ) which was defined as 4.5 log reduction of BCR-ABL on the international scale ( IS ) and determined by reverse transcriptase polymerase chain reaction in two consecutive analyses .

METHODS

Landmark analyses were performed to assess the impact of MR ( 4.5 ) on survival .

RESULTS

Of 1,551 randomly assigned patients , 1,524 were assessable .

RESULTS

After a median observation time of 67.5 months , 5-year overall survival ( OS ) was 90 % , 5-year progression-free-survival was 87.5 % , and 8-year OS was 86 % .

RESULTS

The cumulative incidence of MR ( 4.5 ) after 9 years was 70 % ( median , 4.9 years ) ; confirmed MR ( 4.5 ) was 54 % .

RESULTS

MR ( 4.5 ) was reached more quickly with optimized high-dose imatinib than with imatinib 400 mg/day ( P = .016 ) .

RESULTS

Independent of treatment approach , confirmed MR ( 4.5 ) at 4 years predicted significantly higher survival probabilities than 0.1 % to 1 % IS , which corresponds to complete cytogenetic remission ( 8-year OS , 92 % v 83 % ; P = .047 ) .

RESULTS

High-dose imatinib and early major molecular remission predicted MR ( 4.5 ) .

RESULTS

No patient with confirmed MR ( 4.5 ) has experienced progression .

CONCLUSIONS

MR ( 4.5 ) is a new molecular predictor of long-term outcome , is reached by a majority of patients treated with imatinib , and is achieved more quickly with optimized high-dose imatinib , which may provide an improved therapeutic basis for treatment discontinuation in CML .

OBJECTIVE

To compare the efficacy and safety of endoscopic dacryocystorhinostomy ( En-DCR ) with different stent materials for lacrimal sac intubation in primary nasolacrimal ductal obstructions .

METHODS

Randomized controlled study with three parallel groups .

METHODS

Level of evidence is 1b .

METHODS

A total of 91 patients ( five bilateral ) with primary nasolacrimal duct obstruction ( NLDO ) at a tertiary referral center scheduled for En-DCR were to allocated into three stent groups with a sealed envelope and were randomized into three treatments : silicone , Prolene ( polypropylene ) , and otologic T-tube .

METHODS

Ophthalmology and otolaryngology clinics evaluated the patients preoperatively and postoperatively with endoscopes , lacrimal system syringing , and dacryocystography .

METHODS

The success of the stents was evaluated 12 months after surgery with symptom relief and ostial patency .

METHODS

Complications were also noted .

RESULTS

The overall success rate of the En-DCR in the stent groups was 78.1 % ( 75/96 ) ; specifically , 87.5 % ( 28/32 ) with silicone , 84.4 % ( 27/32 ) with Prolene , and 62.5 % ( 20/32 ) with T-tube .

RESULTS

The efficacy of the procedures with the T-tube was significantly lower than that of the Prolene and silicone ( p = .031 , ( 2 ) test ) .

RESULTS

There were no significant differences between the silicone and Prolene ( p = .718 , ( 2 ) test ) .

RESULTS

Prolene was found to be related with orbital complications .

RESULTS

Spontaneous loss is a particular complication of otologic T-tube and highly portends to failure .

CONCLUSIONS

The results of our study suggest that efficacy , defined as anatomic and functional success , is equally high for silicone and Prolene stents and lower for otologic T-tube in En-DCR .

BACKGROUND

Little is known about the longer-term effects of adjunctive benzodiazepines on symptom response during treatment in patients with bipolar disorders .

METHODS

The study sample consisted of 482 patients with bipolar I or II disorder enrolled in a 6-month , randomized , multi-site comparison of lithium - and quetiapine-based treatment .

METHODS

Changes in clinical measures ( BISS total and subscales , CGI-BP , and CGI-Efficacy Index ) were compared between participants who did and did not receive benzodiazepine treatment at baseline or during follow-up .

METHODS

Selected outcomes were also compared between patients who did and did not initiate benzodiazepines during follow-up using stabilized inverse probability weighted analyses .

RESULTS

Significant improvement in all outcome measures occurred within each benzodiazepine exposure group .

RESULTS

Benzodiazepine users ( at baseline or during follow-up ) experienced significantly less improvement in BISS total , BISS irritability , and CGI-BP scores than did benzodiazepine non-users .

RESULTS

There were no significant differences in these measures between patients who did and did not initiate benzodiazepines during follow-up in the weighted analyses .

RESULTS

There was no significant effect of benzodiazepine use on any outcome measure in patients with comorbid anxiety or substance use disorders .

CONCLUSIONS

This is a secondary analysis of data from a randomized effectiveness trial that was not designed to address differential treatment response according to benzodiazepine use .

CONCLUSIONS

Adjunctive benzodiazepines may not significantly affect clinical outcome in lithium - or quetiapine-treated patients with bipolar I or II disorder over 6 months , after controlling for potential confounding factors .

BACKGROUND

Most patients with diabetic kidney disease ( DKD ) experience disease progression despite receiving standard care therapy .

BACKGROUND

Oxidative stress is associated with DKD severity and risk of progression , but currently approved therapies do not directly attenuate the pathologic consequences of oxidative stress .

BACKGROUND

GS-4997 is a once daily , oral molecule that inhibits Apoptosis Signal-regulating Kinase 1 ( ASK1 ) , which is a key mediator of the deleterious effects of oxidative stress .

METHODS

We describe the rationale and design of a Phase 2 placebo-controlled clinical trial investigating the effects of GS-4997 in patients with T2DM and stage 3/4 DKD receiving standard of care therapy .