Search results for "Randomized controlled trial"
showing 10 items of 2199 documents
Long-Term Use of Deferiprone Enhances Significantly the Left Ventricular Ejection Function in Thalassemia Major
2011
Abstract Abstract 5302 Background: A multicentre randomized controlled trial (RCT) was designed to assess the effectiveness of long-term sequential deferiprone-deferoxamine (DFO-DFP) versus DFP alone to treat thalassaemia major (TM) (Maggio et al.,2009). Effectviness, survival, adverse events and costs were comparable between the groups. These findings were confirmed in a further 21-month follow-up (Pantalone et al., 2011). Moreover, deferiprone-alone has been reported to be superior to deferoxamine for the removal of cardiac iron and improvement in left ventricular ejection function (LVEF). However, little is known of its relative effect on LVEF after long-term treatment. Therefore, data f…
Assessment and management of agitation in psychiatry: Expert consensus
2016
International audience; BACKGROUND:Psychomotor agitation is associated with different psychiatric conditions and represents an important issue in psychiatry. Current recommendations on agitation in psychiatry are not univocal. Actually, an improper assessment and management may result in unnecessary coercive or sedative treatments. A thorough and balanced review plus an expert consensus can guide assessment and treatment decisions.METHODS:An expert task force iteratively developed consensus using the Delphi method. Initial survey items were based on systematic review of the literature. Subsequent surveys included new, re-worded or re-rated items.RESULTS:Out of 2175 papers assessing psychomo…
A Multicenter International Randomized Controlled Manikin Study on Different Protocols of Cardiopulmonary Resuscitation for Laypeople: The MANI-CPR T…
2021
Background Compression-only cardiopulmonary resuscitation (CPR) is a suggested technique for laypeople facing out-of-hospital cardiac arrest (OHCA). However, it is difficult performing high-quality CPR until emergency medical services arrival with this technique. We aimed to verify whether incorporating intentional interruptions of different frequency and duration increases laypeople's CPR quality during an 8-minute scenario compared with compression-only CPR. Methods We performed a multicenter randomized manikin study selecting participants from 2154 consecutive laypeople who followed a basic life support/automatic external defibrillation course. People who achieved high-quality CPR in 1-m…
Treatment effect of alirocumab according to age group, smoking status, and hypertension: Pooled analysis from 10 randomized ODYSSEY studies
2019
Background: Age, smoking, hypercholesterolemia, and hypertension are major risk factors for atherosclerotic cardiovascular disease. Objective: We examined whether the effects of alirocumab on low-density lipoprotein cholesterol (LDL-C) differed according to age, hypertension, or smoking status. Methods: Data were pooled from 10 Phase 3 ODYSSEY randomized trials (24–104 weeks’ duration) in 4983 people with heterozygous familial hypercholesterolemia (FH) or non–familial hypercholesterolemia (3188 on alirocumab, 1795 on control [620 on ezetimibe and 1175 on placebo]). Most participants received concomitant maximum tolerated statin therapy. In 8 trials, the alirocumab dose was increased from 75…
Effects of aerobic exercise and diet intervention on glycaemic control and liver fat content in men and women aged 50–65 years with prediabetes and n…
2016
Abstract Background Prediabetes and non-alcoholic fatty liver disease precede development of type 2 diabetes; however, appropriate lifestyle interventions might help to prevent such progression. We aimed to test whether aerobic exercise training and a high-fibre diet can reduce hepatic fat content and increase insulin sensitivity in individuals with prediabetes and non-alcoholic fatty liver disease. Methods We did a randomised controlled trial in seven clinics in Yangpu district, Shanghai, China. We recruited individuals aged 50–65 years with impaired fasting glucose (5·6–6·9 mmol/L) or impaired glucose tolerance (2 h glucose 7·8–11·0 mmol/L) and diagnosed non-alcoholic fatty liver disease.…
Outcomes of monopolar versus bipolar endometrial ablation on uterine bleeding and psychophysical wellbeing.
2017
Background To compare outcomes of endometrial ablation with monopolar versus bipolar resection on uterine bleeding and psychophysical wellbeing. Methods In a prospective randomized study, 100 perimenopausal patients, without desire of pregnancy and with no response to pharmacological treatment, underwent endometrial ablation from 2012 to 2014. They were randomly divided in two groups: 50 patients treated with monopolar electrode resection loop (group A) and 50 patients treated with bipolar electrode resection loop (group B). Operative parameters were immediately assessed. Menstrual outcome parameters and psycho-physical well-being parameters were evaluated after 12 months. Results No signif…
Calculation of NNTs in RCTs with time-to-event outcomes: A literature review
2008
Abstract Background The number needed to treat (NNT) is a well-known effect measure for reporting the results of clinical trials. In the case of time-to-event outcomes, the calculation of NNTs is more difficult than in the case of binary data. The frequency of using NNTs to report results of randomised controlled trials (RCT) investigating time-to-event outcomes and the adequacy of the applied calculation methods are unknown. Methods We searched in PubMed for RCTs with parallel group design and individual randomisation, published in four frequently cited journals between 2003 and 2005. We evaluated the type of outcome, the frequency of reporting NNTs with corresponding confidence intervals,…
Efficacy and safety of a new hyaluronic acid dermal filler in the treatment of severe nasolabial lines - 6-month interim results of a randomized, eva…
2011
Summary Background Hyaluronic acid (HA) fillers are frequently used for the correction of facial soft tissue defects. Aim To compare the efficacy and safety of a novel HA filler, HAE (Emervel Deep), with those of HAP (Restylane Perlane) in the treatment of severe nasolabial folds (NLF). Patients/Methods A split-face, randomized and evaluator-blinded comparison study. Subjects were randomized to receive injection of HAE or HAP on their left or right NLF. Efficacy was evaluated based on the change in Wrinkle Severity Rating Scale (WSRS) from baseline. Local tolerability was assessed based on subject diary during the first 3 weeks after injection. Adverse events were also evaluated. Results…
Effectiveness of semi-permeable dressings to treat radiation-induced skin reactions. A systematic review
2017
The aim of this systematic review is to assess the available evidence concerning the effectiveness of semi-permeable dressings, on the full range of skin reactions, related to radiation therapy in cancer patients, from local erythema to moist desquamation, including subjective symptoms such as pain, discomfort, itchiness, burning and the effect on daily life activities. The bibliographic search was carried out looking for Randomised Clinical Trials (RCTs) indexed in PubMed, Cinhal, Cochrane plus and Biblioteca Nacional de Salud, published in the English and Spanish language, between 2010 and 2015. Data extraction and evaluation of study quality was undertaken by peer reviewers using the Cri…
Meta-analysis of Randomized Controlled Trials and Individual Patient Data Comparing Minimally Invasive With Open Oesophagectomy for Cancer
2021
Minimally invasive oesophagectomy (MIO) for oesophageal cancer may reduce surgical complications compared with open oesophagectomy. MIO is, however, technically challenging and may impair optimal oncological resection. The aim of the present study was to assess if MIO for cancer is beneficial.A systematic literature search in MEDLINE, Web of Science and CENTRAL was performed and randomized controlled trials (RCTs) comparing MIO with open oesophagectomy were included in a meta-analysis. Survival was analysed using individual patient data. Random-effects model was used for pooled estimates of perioperative effects.Among 3219 articles, six RCTs were identified including 822 patients. Three-yea…