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The primary outcomes were a clinician 's decision to undertake further intervention to control bleeding , and the difference between preoperative and postoperative hemoglobin levels .
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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 ) .
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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 ) .
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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 .
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Australian New Zealand Clinical Trials Registry : ACTRN12613000348752 .
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Exercise training is recommended for chronic heart failure ( HF ) patients to improve functional status and reduce risk of adverse outcomes .
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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 .
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Whether exercise training leads to improvements in biomarkers and how such improvements relate to clinical outcomes are unclear .
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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 % ) .
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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 .
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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 .
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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 .
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Controlling for baseline biomarker levels or volume of exercise did not alter these findings .
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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 .
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Exercise training did not lead to meaningful changes in biomarkers of myocardial stress , inflammation , or necrosis in patients with chronic HF .
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Only improvements in NT-proBNP translated to reductions in peak VO2 and reduced risk of clinical events .
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Biofortification is a strategy to relieve vitamin A ( VA ) deficiency .
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Biofortified maize contains enhanced provitamin A concentrations and has been bioefficacious in animal and small human studies .
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The study sought to determine changes in total body reserves ( TBRs ) of vitamin A with consumption of biofortified maize .
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A randomized , placebo-controlled biofortified maize efficacy trial was conducted in 140 rural Zambian children .
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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 .
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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 + ) .
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In total , 133 children completed the trial and were analyzed for TBRs ( n = 44 or 45/group ) .
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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 .
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Nonparametric analysis showed no statistical difference between VA + and orange ( P = 0.34 ) ; both were higher than VA - ( P = 0.0034 ) .
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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 .
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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 .
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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 .
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- 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 .
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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 .
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This trial was registered at clinicaltrials.gov as NCT01814891 .
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Submassive pulmonary embolism ( PE ) has a low mortality rate but can degrade functional capacity .
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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 .
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This investigator-initiated study was funded by a contract between a corporate partner and the investigator 's hospital ( the prime site ) .
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The investigator was the Food and Drug Administration ( FDA ) sponsor .
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The prime site subcontracted , indemnified , and trained consortia members .
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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 .
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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 ) .
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The planned sample size was n = 200 .
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Eight sites enrolled 87 patients over 5 years .
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The ratio of patients screened for each enrolled was 7.4 to 1 , equating to 11 h screening time per patient enrolled .
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Primary barrier to enrolment was the cost of screening .
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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 .
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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 .
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Quality of life measurements might represent a more important patient-centred end-point .
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Crashes are the leading cause of death for teens , and parent-based interventions are a promising approach .
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We assess the effectiveness of Steering Teens Safe , a parent-focused program to increase safe teen driving .
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Steering Teens Safe aimed to improve parental communication with teens about safe driving using motivational interviewing techniques in conjunction with 19 safe driving lessons .
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A randomized controlled trial involved 145 parent-teen dyads ( 70 intervention and 75 control ) .
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Intervention parents received a 45-minute session to learn the program with four follow-up phone sessions , a DVD , and a workbook .
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Control parents received a standard brochure about safe driving .
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Scores were developed to measure teen-reported quantity and quality of parental communication about safe driving .
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The main outcome measure was a previously validated Risky Driving Score reported by teens .
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Because the Score was highly skewed , a generalized linear model based on a gamma distribution was used for analysis .
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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 ) .
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The Risky Driving Score was 21 % lower in intervention compared to control teens ( 85 % CI = 0.60 , 1.00 ) .
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Interaction between communication quantity and the intervention was examined .
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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 .
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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 .
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ClinicalTrials.gov NCT01014923 .
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Registered Nov. 16 , 2009 .
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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 .
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It is unclear how many patients achieve MR ( 4.5 ) under different treatment modalities and whether MR ( 4.5 ) predicts survival .
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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 .
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Landmark analyses were performed to assess the impact of MR ( 4.5 ) on survival .
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Of 1,551 randomly assigned patients , 1,524 were assessable .
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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 % .
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The cumulative incidence of MR ( 4.5 ) after 9 years was 70 % ( median , 4.9 years ) ; confirmed MR ( 4.5 ) was 54 % .
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MR ( 4.5 ) was reached more quickly with optimized high-dose imatinib than with imatinib 400 mg/day ( P = .016 ) .
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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 ) .
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High-dose imatinib and early major molecular remission predicted MR ( 4.5 ) .
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No patient with confirmed MR ( 4.5 ) has experienced progression .
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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 .
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To compare the efficacy and safety of endoscopic dacryocystorhinostomy ( En-DCR ) with different stent materials for lacrimal sac intubation in primary nasolacrimal ductal obstructions .
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Randomized controlled study with three parallel groups .
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Level of evidence is 1b .
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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 .
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Ophthalmology and otolaryngology clinics evaluated the patients preoperatively and postoperatively with endoscopes , lacrimal system syringing , and dacryocystography .
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The success of the stents was evaluated 12 months after surgery with symptom relief and ostial patency .
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Complications were also noted .
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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 .
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The efficacy of the procedures with the T-tube was significantly lower than that of the Prolene and silicone ( p = .031 , ( 2 ) test ) .
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There were no significant differences between the silicone and Prolene ( p = .718 , ( 2 ) test ) .
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Prolene was found to be related with orbital complications .
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Spontaneous loss is a particular complication of otologic T-tube and highly portends to failure .
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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 .
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Little is known about the longer-term effects of adjunctive benzodiazepines on symptom response during treatment in patients with bipolar disorders .
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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 .
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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 .
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Selected outcomes were also compared between patients who did and did not initiate benzodiazepines during follow-up using stabilized inverse probability weighted analyses .
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Significant improvement in all outcome measures occurred within each benzodiazepine exposure group .
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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 .
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There were no significant differences in these measures between patients who did and did not initiate benzodiazepines during follow-up in the weighted analyses .
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There was no significant effect of benzodiazepine use on any outcome measure in patients with comorbid anxiety or substance use disorders .
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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 .
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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 .
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Most patients with diabetic kidney disease ( DKD ) experience disease progression despite receiving standard care therapy .
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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 .
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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 .
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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 .
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