Search results for "Randomized controlled"
showing 10 items of 2220 documents
High flow nasal therapy versus noninvasive ventilation as initial ventilatory strategy in COPD exacerbation: a multicenter non-inferiority randomized…
2020
Abstract Background The efficacy and safety of high flow nasal therapy (HFNT) in patients with acute hypercapnic exacerbation of chronic obstructive pulmonary disease (AECOPD) are unclear. Our aim was to evaluate the short-term effect of HFNT versus NIV in patients with mild-to-moderate AECOPD, with the hypothesis that HFNT is non-inferior to NIV on CO2 clearance after 2 h of treatment. Methods We performed a multicenter, non-inferiority randomized trial comparing HFNT and noninvasive ventilation (NIV) in nine centers in Italy. Patients were eligible if presented with mild-to-moderate AECOPD (arterial pH 7.25–7.35, PaCO2 ≥ 55 mmHg before ventilator support). Primary endpoint was the mean di…
Efficacy of a House Dust Mite Sublingual Allergen Immunotherapy Tablet in Adults With Allergic Asthma: A Randomized Clinical Trial.
2016
Importance The house dust mite (HDM) sublingual allergen immunotherapy (SLIT) tablet is a potential novel treatment option for HDM allergy–related asthma. Objectives To evaluate the efficacy and adverse events of the HDM SLIT tablet vs placebo for asthma exacerbations during an inhaled corticosteroid (ICS) reduction period. Design, Settings, and Participants Double-blind, randomized, placebo-controlled trial conducted between August 2011 and April 2013 in 109 European trial sites. The trial included 834 adults with HDM allergy–related asthma not well controlled by ICS or combination products, and with HDM allergy–related rhinitis. Key exclusion criteria were FEV 1 less than 70% of predicted…
Effects of a weight management program delivered by social media on weight and metabolic syndrome risk factors in overweight and obese adults: A rand…
2017
Author(s): Jane, Monica; Hagger, Martin; Foster, Jonathan; Ho, Suleen; Kane, Robert; Pal, Sebely | Abstract: IntroductionThe aim of this project was to evaluate the effectiveness of using social media to augment the delivery of, and provide support for, a weight management program delivered to overweight and obese individuals during a twenty four week intervention.MethodsParticipants randomly divided into either one of two intervention groups or a control group. The two intervention groups were instructed to follow identical weight-management program. One group received the program within a Facebook group, along with a support network with the group, and the other intervention group receive…
The family-oriented Open Dialogue approach in the treatment of first-episode psychosis : nineteen–year outcomes
2018
Open Dialogue (OD) is a family-oriented early intervention approach which has demonstrated good outcomes in the treatment of first-episode psychosis (FEP). Nevertheless, more evidence is needed. In this register-based cohort study the long-term outcomes of OD were evaluated through a comparison with a control group over a period of approximately 19 years. We examined the mortality, the need for psychiatric treatment, and the granting of disability allowances. Data were obtained from Finnish national registers regarding all OD patients whose treatment for FEP commenced within the time of the original interventions (total N = 108). The control group consisted of all Finnish FEP patients who h…
Metformin and health outcomes:An umbrella review of systematic reviews with meta-analyses
2021
Background:\ud \ud The objective was to capture the breadth of outcomes that have been associated with metformin use and to systematically assess the quality, strength and credibility of these associations using the umbrella review methodology.\ud \ud Methods:\ud \ud Four major databases were searched until 31 May 2020. Meta‐analyses of observational studies and meta‐analyses of randomized controlled trials (RCTs) (including active and placebo control arms) were included.\ud \ud Results:\ud \ud From 175 eligible publications, we identified 427 different meta‐analyses, including 167 meta‐analyses of observational studies, 147 meta‐analyses of RCTs for metformin vs placebo/no treatment and 11…
Erythropoietin in amyotrophic lateral sclerosis: a multicentre, randomized, double blind, placebo controlled, phase III study.
2015
Objective To assess the efficacy of recombinant human erythropoietin (rhEPO) in amyotrophic lateral sclerosis (ALS). Methods Patients with probable laboratory-supported, probable or definite ALS were enrolled by 25 Italian centres and randomly assigned (1:1) to receive intravenous rhEPO 40 000 IU or placebo fortnightly as add-on treatment to riluzole 100 mg daily for 12 months. The primary composite outcome was survival, tracheotomy or >23 h non-invasive ventilation (NIV). Secondary outcomes were ALSFRS-R, slow vital capacity (sVC) and quality of life (ALSAQ-40) decline. Tolerability was evaluated analysing adverse events (AEs) causing withdrawal. The randomisation sequence was computer-…
Liraglutide and cardiovascular outcomes in type 2 diabetes
2016
The cardiovascular effect of liraglutide, a glucagon-like peptide 1 analogue, when added to standard care in patients with type 2 diabetes, remains unknown. METHODS In this double-blind trial, we randomly assigned patients with type 2 diabetes and high cardiovascular risk to receive liraglutide or placebo. The primary composite outcome in the time-to-event analysis was the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The primary hypothesis was that liraglutide would be noninferior to placebo with regard to the primary outcome, with a margin of 1.30 for the upper boundary of the 95% confidence interval of the hazard ratio. No adjus…
Soft Tissue Response to Titanium Abutments with Different Surface Treatment: Preliminary Histologic Report of a Randomized Controlled Trial
2016
The aim of this preliminary prospective RCT was to histologically evaluate peri-implant soft tissues around titanium abutments treated using different cleaning methods. Sixteen patients were randomized into three groups: laboratory customized abutments underwent Plasma of Argon treatment (Plasma Group), laboratory customized abutments underwent cleaning by steam (Steam Group), and abutments were used as they came from industry (Control Group). Seven days after the second surgery, soft tissues around abutments were harvested. Samples were histologically analyzed. Soft tissues surrounding Plasma Group abutments predominantly showed diffuse chronic infiltrate, almost no acute infiltrate, with …
Effects of intensive strength-power training on sense of coherence among 60-85-year-old people with hip fracture: A randomized controlled trial
2012
Background and aims: Older people with disabilities are at increased risk of psychological health decline. There are no earlier studies on the effects of resistance training on sense of coherence (SOC) among older people with a history of hip fracture. The aim of this study is to test the effects of intensive 12-week strength-power training on SOC among older adults after hip fracture. Methods: A clinical sample of 60-85-year-old community-dwelling men and women was studied, 0.5. to 7.0 years after hip fracture. Forty-six had no contraindications for participation and were randomized into training (n=24) and control groups (n=22). The training group participated in a 12-week, individually t…
The Norwegian Healthy Life Study: protocol for a pragmatic RCT with longitudinal follow-up on physical activity and diet for adults
2017
The Norwegian Directorate of Health recommends that Healthy Life Centres (HLCs) be established in primary health care to support behaviour change and reduce the risk of non-communicable diseases. The aim of the present study protocol is to present the rationale, design and methods of a combined pragmatic randomized controlled trial (RCT) and longitudinal cohort study of the effects of attending HLCs concerning physical activity, sedentary behaviour and diet and to explore how psychological well-being and motivational factors may mediate short— and long-term effects. The present study will combine a 6-month RCT with a longitudinal cohort study (24 months from baseline) conducted at six HLCs …