Search results for "Randomized Controlled Trial"
showing 10 items of 2199 documents
Low-Carbohydrate High-Fat Diet and Exercise: Effect of a 10-Week Intervention on Body Composition and CVD Risk Factors in Overweight and Obese Women—…
2020
We assessed the effect of weight-loss induced with a low-carbohydrate-high-fat diet with and without exercise, on body-composition, cardiorespiratory fitness and cardiovascular risk factors. A total of 57 overweight and obese women (age 40 ±
Safety and Effectiveness of Progressive Moderate-to-Vigorous Intensity Elastic Resistance Training on Physical Function and Pain in People With Hemop…
2020
Abstract Objective Strength training is recommended for people with hemophilia; however, published data are anecdotal and have methodological limitations. The purpose of this study was to evaluate the safety and effectiveness of progressive moderate-to-vigorous intensity elastic resistance training on physical function and pain in this patient population. Methods A randomized controlled trial was conducted in a university laboratory setting where 20 patients (17 with severe, 1 with moderate, and 2 with mild hemophilia) aged 21 to 53 years received evaluations at baseline and 8-week follow-up. Participants were allocated to intervention (progressive strength training) or control (usual daily…
Clinical validation of embryo culture and selection by morphokinetic analysis: a randomized, controlled trial of the EmbryoScope.
2014
Objective To determine whether incubation in the integrated EmbryoScope time-lapse monitoring system (TMS) and selection supported by the use of a multivariable morphokinetic model improve reproductive outcomes in comparison with incubation in a standard incubator (SI) embryo culture and selection based exclusively on morphology. Design Prospective, randomized, double-blinded, controlled study. Setting University-affiliated private in vitro fertilization (IVF) clinic. Patient(s) Eight hundred forty-three infertile couples undergoing intracytoplasmic sperm injection (ICSI). Intervention(s) No patient intervention; embryos cultured in SI with development evaluated only by morphology (control …
Multi-domain impact of elosufase alfa in Morquio A syndrome in the pivotal phase III trial
2015
Objective: To report and discuss the multi-domain impact of elosulfase alfa, with focus on tertiary and composite endpoints, in the 24-week, randomized, double-blind, placebo-controlled phase 3 trial in patients with Morquio A syndrome (mucopolysaccharidosis IVA). Methods: Patients with Morquio A syndrome >= 5 aged years were randomized 1:1:1 to elosulfase alfa 2.0 mg/kg/week (qw; N = 58), elosulfase alfa 2.0 mg/kg/every other week (qow; N = 59), or placebo (N = 59) for 24 weeks. Primary and secondary efficacy measures were 6-minute walk test (6MWT; primary), 3-minute stair climb test (3-MSCT) and urinary keratan sulfate (KS). Safety was also evaluated. Tertiary efficacy measures included r…
Azathioprine combined with prednisolone or monotherapy with prednisolone in active Crohn's disease
1993
Abstract Background: The role of azathioprine (AZA) in the treatment of active Crohn's disease (CD) is still controversial. This study examined whether AZA combined with standard prednisolone therapy improved the therapeutic outcome compared with monotherapy with prednisolone. Methods: Forty-two patients with a Crohn's Disease Activity Index (CDAI) of > 150 were randomized into two groups. Both received 60 mg of prednisolone daily in a tapering regimen to a maintenance dose of 10 mg. In addition, group 1 received 2.5 mg AZA/kg body wt and group 2 received a placebo over the whole study period of 4 months. Results: At the end of the trial, 16 of 21 patients (76%) in group 1 were in remission…
Bed rest after embryo transfer negatively affects in vitro fertilization: a randomized controlled clinical trial.
2013
Objective To evaluate the influence of 10 minutes of bed rest after ET on the achievement of a live-born infant (LBI) in patients undergoing IVF treatment with oocyte donation (OD). Design Prospective, randomized, parallel assignment, controlled trial. Setting Private IVF center. Patient(s) A total of 240 patients undergoing a first IVF cycle with OD in our center. Intervention(s) Ten minutes of bed rest after ET or no bed rest, that is, allowing patients to ambulate immediately after the ET. Main Outcome Measure(s) The primary outcome was LBI rate per randomized patient. Secondary outcomes were implantation rate and biochemical and clinical miscarriage rates. Result(s) LBI rates (56.7% vs.…
Six-month echocardiographic study in patients with submassive pulmonary embolism and right ventricle dysfunction: comparison of thrombolysis with hep…
2010
Abstract Introduction The aim of this study was to assess the effect of thrombolysis versus heparin treatment on echocardiographic parameters and clinical outcome, during hospitalization and within the first 180 days after admission, in patients with first episode of submassive pulmonary embolism (SPE) and right ventricle dysfunction (RVD). Methods Consecutive patients (age, 18–75 years) with a first episode of SPE, symptoms onset since no more than 6 hours, normal blood pressure (> 100 mm Hg), echocardiographic evidence of RVD and positive lung spiral computed tomography were double-blind randomized: 1 group received 100 mg of alteplase (10-mg bolus, followed by a 90-mg intravenous infusio…
Effectiveness of cognitive behavioral therapy supported by virtual reality in the treatment of body image in eating disorders: One year follow-up
2013
Body image disturbance is a significant maintenance and prognosis factor in eating disorders. Hence, existing eating disorder treatments can benefit from direct intervention in patients' body image. No controlled studies have yet compared eating disorder treatments with and without a treatment component centered on body image. This paper includes a controlled study comparing Cognitive Behavioral Treatment (CBT) for eating disorders with and without a component for body image treatment using Virtual Reality techniques. Thirty-four participants diagnosed with eating disorders were evaluated and treated. The clinical improvement was analyzed from statistical and clinical points of view. Result…
Evidence of bias in randomized clinical trials of hepatitis C interferon therapies
2017
Introduction: Bias may occur in randomized clinical trials in favor of the new experimental treatment because of unblinded assessment of subjective endpoints or wish bias. Using results from published trials, we analyzed and compared the treatment effect of hepatitis C antiviral interferon therapies experimental or control. Methods: Meta-regression of trials enrolling naïve hepatitis C virus patients that underwent four therapies including interferon alone or plus ribavirin during past years. The outcome measure was the sustained response evaluated by transaminases and/or hepatitis C virus-RNA serum load. Data on the outcome across therapies were collected according to the assigned arm (exp…
Effects of anemia correction with epoetin beta in patients receiving radiochemotherapy for advanced cervical cancer
2007
Patients with cervical cancer frequently suffer from anemia. This two-stage, adaptive-design study investigated the effect of anemia correction with epoetin beta on treatment outcomes. Patients with stage IIB–IVA cervical cancer received radiochemotherapy (RCT) and were randomized to epoetin 150 IU/kg three times weekly (n = 34) or standard care (control; n = 40) for up to 12 weeks. Primary end point for stage 1 aimed to establish a correlation between anemia correction and treatment failure (no complete response or relapsing within 6 months after RCT initiation) as a proof of concept before moving into stage 2. Secondary end points included progression/relapse-free survival, overall surviv…