Search results for "Randomized controlled"

Home-Based Resistance Training for Older Subjects during the COVID-19 Outbreak in Italy: Preliminary Results of a Six-Months RCT.

2020

Background. The aim of this study was to evaluate the effect of a six-month home-based resistance-training program on muscle health and physical performance in healthy older subjects during the unique condition of home confinement caused by the COVID-19 pandemic. Methods. This was a randomized-controlled study that enrolled older participants that were allocated to either an experimental group performing the six-months exercise prescription (EXE) or a control group (CON). At the beginning (PRE), and after 6 months (POST), participants were assessed for muscle strength, balance, gait assessment and body composition by dual energy X-ray absorptiometry and magnetic resonance imaging. Normality…

Recent Randomized Trials of Antithrombotic Therapy for Patients With COVID-19

2021

Endothelial injury and microvascular/macrovascular thrombosis are common pathophysiological features of coronavirus disease-2019 (COVID-19). However, the optimal thromboprophylactic regimens remain unknown across the spectrum of illness severity of COVID-19. A variety of antithrombotic agents, doses, and durations of therapy are being assessed in ongoing randomized controlled trials (RCTs) that focus on outpatients, hospitalized patients in medical wards, and patients critically ill with COVID-19. This paper provides a perspective of the ongoing or completed RCTs related to antithrombotic strategies used in COVID-19, the opportunities and challenges for the clinical trial enterprise, and ar…

Cost-effectiveness and cost-utility analysis of the treatment of emotional disorders in primary care: psicap clinical trial. description of the sub-s…

2018

Introduction: In the primary care (PC) setting in Spain, the prevalence of emotional disorders (EDs) such as anxiety, depression and somatoform disorder is high. In PC patients, these disorders are not always managed in accordance with the recommendations provided by clinical practice guidelines, resulting in major direct and indirect economic costs and suboptimal treatment outcomes. The aim is to analyze and compare the cost-effectiveness and cost-utility of group-based psychological therapy versus treatment as usual (TAU). Methods: Multicenter, randomized controlled trial involving 300 patients recruited from PC centers in Madrid, Spain, with symptoms or possible diagnosis of anxiety, moo…

Effectiveness of Organizational Interventions to Reduce Emergency Department Utilization: A Systematic Review

2012

BackgroundEmergency department (ED) utilization has dramatically increased in developed countries over the last twenty years. Because it has been associated with adverse outcomes, increased costs, and an overload on the hospital organization, several policies have tried to curb this growing trend. The aim of this study is to systematically review the effectiveness of organizational interventions designed to reduce ED utilization.Methodology/principal findingsWe conducted electronic searches using free text and Medical Subject Headings on PubMed and The Cochrane Library to identify studies of ED visits, re-visits and mortality. We performed complementary searches of grey literature, manual s…

High flow nasal therapy in immunocompromised patients with acute respiratory failure: A systematic review and meta-analysis.

2019

Abstract Purpose The role of high-flow nasal therapy (HFNT) as compared to conventional oxygen therapy (COT) in immunocompromised patients admitted to intensive care unit (ICU) with acute respiratory failure (ARF) remains unclear. We conducted a systematic review and meta-analysis in order to address this issue. Methods We searched PubMed, Medline and Embase until November 7th, 2018. Randomized controlled trials (RCTs), non-randomized prospective and retrospective evidence were selected. Observational studies were considered for sensitivity analysis. Primary outcome was mortality rate; intubation rate was a secondary outcome. Results We included four studies in the primary analysis: one RCT…

Evaluation of the UP4FUN Intervention: A Cluster Randomized Trial to Reduce and Break Up Sitting Time in European 10-12-Year-Old Children

2015

Background The UP4FUN intervention is a family-involved school-based intervention aiming at reducing and breaking up sitting time at home (with special emphasis on screen time), and breaking up sitting time in school among 10–12 year olds in Europe. The purpose of the present paper was to evaluate its short term effects. Methodology/Principal Findings A total of 3147 pupils from Belgium, Germany, Greece, Hungary and Norway participated in a school-randomized controlled trial. The intervention included 1–2 school lessons per week for a period of six weeks, along with assignments for the children and their parents. Screen time and breaking up sitting time were registered by self-report and to…

First-Line Treatment with Fludarabine (F), Cyclophosphamide (C), and Rituximab (R) (FCR) Improves Overall Survival (OS) in Previously Untreated Patie…

2009

Abstract Abstract 535 Introduction: In 2008, first results of a multicenter, international randomized phase III trial (CLL8) were presented, showing superiority of FCR chemoimmunotherapy for response rates and progression-free survival (PFS) when compared to FC chemotherapy. We now report updated results with a longer median observation time of 37.7 months (mo). Methods and Patients: 817 treatment-naïve patients (pts) with good physical fitness and CD20-positive CLL randomly (1:1) received treatment with 6 courses of either FCR or FC therapy. Both treatment arms were well balanced with regard to sex, age, stage, genomic aberrations and IGVH gene status. The median age was 61 years (range 3…

Safety of Topical Non-steroidal Anti-Inflammatory Drugs in Osteoarthritis: Outcomes of a Systematic Review and Meta-Analysis

2019

Objective We aimed to assess the safety of topical non-steroidal anti-inflammatory drugs (NSAIDs) in the management of osteoarthritis (OA) in a systematic review and meta-analysis of randomized, placebo-controlled trials. Methods A comprehensive literature search was undertaken in the MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), and Scopus electronic databases. Randomized, double-blind, placebo-controlled, parallel-group trials that assessed adverse events (AEs) with topical NSAIDs in patients with OA were eligible for inclusion. Authors and/or study sponsors were contacted to obtain the full report of AEs. The primary outcomes were overall severe and serious AEs, as w…

2020

This multicenter research investigates the effects of dance movement therapy (DMT) on participants diagnosed with depression. In total, 109 persons participated in the study in various locations in Finland. The participants were 39 years old, on average (range = 18-64 years), and most were female (96%). All participants received treatment as usual (TAU). They were randomized into DMT + TAU (n = 52) or TAU only (n = 57). The participants in the DMT + TAU group were offered 20 DMT sessions twice a week for 10 weeks in addition to standard care. The measurement points included pretreatment measurement at the baseline, posttreatment measurement at the end of the intervention, and a follow-up me…

Effectiveness of a recent topical sialogogue in the management of drug-induced xerostomia

2011

Objectives: Use of certain drugs is the most common aetiology of xerostomia. Systemic sialogogues provide a longer effect than topic ones, but also induce relevant side effects. Topical sialogogues, as malic acid, allow a safe use as they induce no systemic side-effects or pharmacological interactions, being especially interesting in cases of mild hyposalivation and oral dryness, mainly the chronic use of xerostomizing drugs. The aim of this study was to evaluate the clinical effect of 1% malic acid in patients affected by xerostomia due to antihypertensives or antidepressants. Study Design: 10 patients with drug-induced xerostomia were prospectively evaluated before and after using malic a…