Search results for "randomized"
showing 10 items of 2323 documents
Effect of acetyl-l-carnitine in the treatment of diabetic peripheral neuropathy : A systematic review and meta-analysis
2017
Background/aim: Deficiency of acetyl-L-carnitine (ALC) and L-carnitine (LC) appears to play a role in peripheral diabetic neuropathy, although the evidence in humans is still limited. We conducted a systematic review and meta-analysis investigating the effect of ALC on pain and electromyographic parameters in people with diabetic neuropathy. Methods: A literature search in major databases, without language restriction, was undertaken. Eligible studies were randomized controlled trials (RCTs) or pre-and post-test studies. The effect of ALC supplementation on pain perception and electromyographic parameters in patients with diabetic neuropathy was compared vs. a control group (RCTs). The effe…
Increased doses of vaginal progesterone for the prevention of preterm birth in twin pregnancies: a randomised controlled double-blind multicentre tri…
2012
Objective Previous trials have shown little benefit for preventing preterm birth in twin pregnancies using 90–200 mg of daily vaginal natural progesterone. Higher doses have not been tested. Our aim was to determine the efficacy and safety of two different daily doses of vaginal natural progesterone (200 and 400 mg), compared with placebo, for preventing preterm birth in unselected twin pregnancies. Design Randomised controlled double-blind multicentre trial (1:1:1). Setting The study was carried out in five university centres from Valencia, Murcia and Alicante (Spain). Population Women with dichorionic diamniotic twin pregnancies. Methods The women self-inserted two vaginal pessaries …
Process evaluation of a complex workplace intervention to prevent musculoskeletal pain in nursing staff: results from INTEVAL_Spain
2021
Abstract Background INTEVAL_Spain was a complex workplace intervention to prevent and manage musculoskeletal pain among nursing staff. Process evaluations can be especially useful for complex and multifaceted interventions through identifying the success or failure factors of an intervention to improve the intervention implementation. Objectives This study performed a process evaluation of INTEVAL_Spain and aimed to examine whether the intervention was conducted according to the protocol, to investigate the fulfilment of expectations and the satisfaction of workers. Methods The intervention was a two-armed cluster randomized controlled trial and lasted 1 year. The process evaluation include…
Physical Activity After a Hip Fracture: Effect of a Multicomponent Home-Based Rehabilitation Program—A Secondary Analysis of a Randomized Controlled …
2017
Objectives To investigate the effect of a yearlong multicomponent rehabilitation program on the level of physical activity (PA) and the maintenance of the level of PA over 1-year follow-up among older people recovering from a recent hip fracture. Design Secondary analysis of a randomized, controlled, parallel-group trial. Setting Home-based rehabilitation; measurements in university laboratory. Participants Community-dwelling people (N=81) aged ≥60 years recovering from a hip fracture. Participants were randomly assigned to an intervention (n=40) or a control (n=41) group, on average, 42±23 days after discharge from the hospital. Intervention A yearlong intervention included evaluation and …
Safety self-efficacy and internal locus of control as mediators of safety motivation – Randomized controlled trial (RCT) study
2019
Abstract Behavioral factors play a fundamental role in preventing occupational injuries and accidents. Previous studies have shown that engagement in safety behavior is influenced by workers’ safety motivation. However, understanding of the cognitive factors that contribute to safety motivation is lacking. In this study, we examine internal safety locus of control and safety self-efficacy as mediators of the effects of a safety intervention on safety motivation. In 2016, 464 students from eight vocational schools participated in a school-based cluster randomized, controlled intervention study conducted in Finland. In the multiple mediation model investigated using structural equation modeli…
Pressure support ventilation + sigh in acute hypoxemic respiratory failure patients: Study protocol for a pilot randomized controlled trial, the PROT…
2018
Background Adding cyclic short sustained inflations (sigh) to assisted ventilation yields optimizes lung recruitment, decreases heterogeneity and reduces inspiratory effort in patients with acute hypoxemic respiratory failure (AHRF). These findings suggest that adding sigh to pressure support ventilation (PSV) might decrease the risk of lung injury, shorten weaning and improve clinical outcomes. Thus, we conceived a pilot trial to test the feasibility of adding sigh to PSV (the PROTECTION study). Methods PROTECTION is an international randomized controlled trial that will be conducted in 23 intensive care units (ICUs). Patients with AHRF who have been intubated from 24 h to 7 days and under…
Effects of exercise frequency and training volume on bone changes following a multi-component exercise intervention in middle aged and older men: Sec…
2021
Progressive resistance training (PRT) combined with weight-bearing impact exercise are recommended to optimize bone health, but the optimal frequency and dose of training remains uncertain. This study, which is a secondary analysis of an 18-month intervention in men aged 50–79 years, examined the association between exercise frequency and the volume of training with changes in DXA and QCT-derived femoral neck (FN) and lumbar spine (LS) bone outcomes, respectively. Men were allocated to either thrice-weekly PRT plus impact exercise training (n = 87) or a non-exercising (n = 85) group. Average weekly exercise frequency (ExFreq) and training volume per session [PRT volume (weight lifted, kg), …
Efficacy of Sequential Ipilimumab Monotherapy versus Best Supportive Care for Unresectable Locally Advanced/Metastatic Gastric or Gastroesophageal Ju…
2017
Abstract Purpose: Ipilimumab, a monoclonal antibody that blocks cytotoxic T-lymphocyte–associated protein-4 interactions, enhances T-cell activation and promotes tumor immunity. This phase II study evaluated the safety and efficacy of ipilimumab monotherapy versus best supportive care (BSC) among patients with advanced/metastatic gastric or gastroesophageal junction cancer who achieved at least stable disease with first-line chemotherapy. Experimental Design: Eligible patients were randomized to ipilimumab 10 mg/kg every 3 weeks for four doses, then 10 mg/kg every 12 weeks for up to 3 years, or BSC, which could include continuation of fluoropyrimidine until progression or toxicity. The prim…
Improvements in functional capacity from Nordic walking: a randomized-controlled trial among elderly people.
2011
This study examined the effects of an instructed structured Nordic walking (NW) exercise program on the functional capacity of older sedentary people. Volunteers were randomly assigned to an NW group (68.2 ± 3.8 yr old) or control group (69.9 ± 3.0 yr old). Before and at the end of the 9-wk intervention, functional tests and 2-dimensional ground-reaction-force (GRF) patterns of normal (1.40 m/s) and fast (1.94 m/s) walking speeds were measured. The intervention included a 60-min supervised NW session on an inside track twice a week for 9 wk. The mean changes in functional tests differed between groups significantly. Gait analyses showed no significant differences between the groups on any G…
Internal limiting membrane peeling versus no peeling during primary vitrectomy for rhegmatogenous retinal detachment: A systematic review and meta-an…
2018
Background Internal limiting membrane (ILM) peeling during primary vitrectomy for rhegmatogenous retinal detachment (RRD) prevents the formation of postoperative macular epiretinal membrane (ERM). However, studies that compared vitrectomy with and without ILM peeling for RRD, have reported controversial outcomes. Objective To assess the efficacy of ILM peeling versus non-ILM peeling during vitrectomy for RRD by a systematic review and meta-analysis of published studies. Methods PubMed, Medline, Web of Science, Embase databases, and the Cochrane Library were searched up to April 2018 to identify studies that compared primary vitrectomy with and without ILM peeling for RRD with at least six m…