Search results for "Randomized Controlled Trial"

A randomized, multinational, noninferiority, phase III trial to evaluate the safety and efficacy of BF-200 aminolaevulinic acid gel vs. methyl aminol…

2018

Background: Basal cell carcinoma (BCC) represents the most common nonmelanoma skin cancer worldwide, affecting mainly adult, fair-skinned individuals. The World Health Organization distinguishes aggressive and nonaggressive forms, of which prototypical variants of the latter are primary nodular and superficial BCC. Objective: To demonstrate noninferiority of BF-200 ALA (a nanoemulsion gel containing 5-aminolaevulinic acid) compared with MAL (a cream containing methyl aminolaevulinate) in the treatment of nonaggressive BCC with photodynamic therapy (PDT). Noninferiority of the primary efficacy variable (overall patient complete response 12 weeks after last PDT) would be declared if the mean …

Single-centre, triple-blinded, randomised, 1-year, parallel-group, superiority study to compare the effects of Roux-en-Y gastric bypass and sleeve ga…

2019

IntroductionBariatric surgery is increasingly recognised as an effective treatment option for subjects with type 2 diabetes and obesity; however, there is no conclusive evidence on the superiority of Roux-en-Y gastric bypass or sleeve gastrectomy. The Oseberg study was designed to compare the effects of gastric bypass and sleeve gastrectomy on remission of type 2 diabetes and β-cell function.Methods and analysisSingle-centre, randomised, triple-blinded, two-armed superiority trial carried out at the Morbid Obesity Centre at Vestfold Hospital Trust in Norway. Eligible patients with type 2 diabetes and obesity were randomly allocated in a 1:1 ratio to either gastric bypass or sleeve gastrecto…

Should low high-density lipoprotein cholesterol (HDL-C) be treated?

2014

The first observations linking a low serum level of HDL-C to increased risk for cardiovascular disease were made over 50 years ago. High serum levels of HDL-C appear to protect against the development of atherosclerotic disease, while low serum levels of this lipoprotein are among the most important predictors of atherosclerotic disease in both men and women and people of all racial and ethnic groups throughout the world. It has long been assumed that therapeutic interventions targeted at raising HDL-C levels would lower risk for such cardiovascular events as myocardial infarction, ischemic stroke, and death. Even after five decades of intensive investigation, evidence to support this assum…

Effects of statins on lipid profile in chronic kidney disease patients: a meta-analysis of randomized controlled trials

2013

The available data on statin effects in chronic kidney disease (CKD) patients are still conflicting. We investigated the impact of short- and long-term statin therapy on lipid profiles in CKD patients requiring or not requiring dialysis.Data from Scopus, PubMed, Web of Science, and the Cochrane Library from 1966 to May 2012 were searched for studies that investigated this effect. We included all randomized controlled clinical trials that investigated the impact of statin therapy on lipids and lipoproteins.The final analysis included 16 trials with 3594 subjects. In CKD patients, statin therapy significantly reduced total cholesterol (TC), triglycerides (TG) and low-density lipoprotein chole…

Motivational characteristics and resistance training in older adults: A randomized controlled trial and 1-year follow-up

2018

The aim of this study was to investigate the effects of a 9‐month supervised resistance training intervention on motivational and volitional characteristics related to exercise, and whether the absolute level and/or intervention‐induced change in these characteristics predict self‐directed continuation of resistance training 1 year after the intervention. Community dwelling older adults aged 65‐75, who did not fulfill physical activity recommendations, were randomized into resistance training intervention groups: training once‐ (n = 26), twice‐ (n = 27), three‐times‐a‐week (n = 28) or non‐training control group (n = 25). Training groups participated in supervised resistance training for 9 m…

Comparison of intramuscular and subcutaneous administration of a herpes zoster live-attenuated vaccine in adults aged ≥50 years: a randomised non-inf…

2015

AbstractZostavax® is a live, attenuated varicella zoster virus (VZV) vaccine developed specifically for the prevention of HZ and PHN in individuals aged ≥50 years. During the clinical development of Zostavax, which was mainly in the US, the vaccine was administrated by the subcutaneous (SC) route. In Europe, many healthcare professionals prefer administering vaccines by the intramuscular (IM) route. This was an open-label, randomised trial conducted in 354 subjects aged ≥50 years. The primary objectives were to demonstrate that IM administration is both non-inferior to SC administration in terms of 4-week post-vaccination geometric mean titres (GMTs), and elicits an acceptable geometric mea…

Clinic modelling randomised trials (CMRT's) in animals as a new intermediate between biological experiments and randomised clinical trials: applicati…

1998

Popliteal Artery Aneurysm Repair in the Endovascular Era: Fourteen-Years Single Center Experience

2015

Abstract To compare outcomes of popliteal artery aneurysm (PAA) repair by endovascular treatment, great saphenous vein (GSV) bypass, and prosthetic bypass. Single center retrospective analysis of patients presenting PAA from 2000 to 2013. Patients were divided into endovascular treatment (group A); GSV bypass (group B); and prosthetic graft bypass (group C). Outcomes were technical success, perioperative mortality, and morbidity. Survival, primary and secondary patency, and freedom from reintervention rate were estimated. Differences in ankle-brachial index (ABI), in-hospital length of stay (InH-Los), red blood cell (RBC) transfusion, and limb loss were reported. Mean follow-up was 49 (medi…

Comparative responses to three different types of interferon-α in patients with chronic hepatitis C

1999

We investigated the efficacy and tolerability of three different types of interferon-alpha, administered with the same schedule to naive patients with chronic hepatitis C. One hundred and seven patients with histologically proven chronic hepatitis C were enrolled during a period of three years and randomly divided into three groups, to receive (a) leukocyte-interferon-alpha, 6 MU three times a week for 4 months, followed by 3 MU three times a week for 8 months (Group I); (b) recombinant-IFN-alpha-2a, with the same schedule (Group II); and (c) lymphoblastoid-IFN-alpha-N1, with the same schedule (Group III). All patients were followed-up for 6 months to evaluate the long-term response. The 'C…

Effects of physical and cognitive training on gait speed and cognition in older adults: A randomized controlled trial

2021

Gait speed is a measure of health and functioning. Physical and cognitive determinants of gait are amenable to interventions, but best practices remain unclear. We investigated the effects of a 12-month physical and cognitive training (PTCT) on gait speed, dual-task cost in gait speed, and executive functions (EFs) compared with physical training (PT) (ISRCTN52388040). Community-dwelling older adults, who did not meet physical activity recommendations, were recruited (n = 314). PT included supervised walking/balance (once weekly) and resistance/balance training (once weekly), home exercises (2-3 times weekly), and moderate aerobic activity 150 min/week in bouts of >10 min. PTCT included the…