Search results for "Randomized"
showing 10 items of 2323 documents
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…
Dissection of lymph node metastases in esophageal cancer.
2011
There has been much recent debate regarding the best surgical procedure to treat esophageal cancer, in particular with regard to the optimum extent of lymphadenectomy to improve survival while minimizing morbidity. No results obtained by prospective, randomized studies on the comparison of radical esophagectomy and extended lymphadenectomy with limited or less invasive resections following neoadjuvant therapy with regard to perioperative morbidity and prognosis are available to date. Until now, there has been no evidence suggesting the usefulness of sentinel lymph node navigation in esophageal cancers, regardless of the cell type. Furthermore, the question as to the benefits and risks of tw…
Preoperative chemoradiotherapy for oesophageal cancer: a systematic review and meta-analysis
2004
Background: The benefit of neoadjuvant chemoradiotherapy in oesophageal cancer has been extensively studied but data on survival are still equivocal. Objective: To assess the effectiveness of chemoradiotherapy followed by surgery in the reduction of mortality in patients with resectable oesophageal cancer. Methods: Computerised bibliographic searches of MEDLINE and CANCERLIT (1970–2002) were supplemented with hand searches of reference lists. Study selection: Studies were included if they were randomised controlled trials (RCTs) comparing preoperative chemoradiotherapy plus surgery with surgery alone, and if they included patients with resectable histologically proven oesophageal cancer wit…
Effects of pelvic and core strength training on biomechanical risk factors for anterior cruciate ligament injuries.
2020
BACKGROUNDː Little is known about the changes in biomechanical risk factors for an anterior cruciate ligament (ACL ) injury after participation in a pelvic and core strength training (PC ST) program in female team players. METHOD Sː This is a randomized controlled trial for which a total of 29 female soccer players were recruited from a soccer club and split into two groups, namely, experimental group (EG, N.=18; mean [SD] age, 17.8±2.0 years, weight 64.0 [6.6 kg and height 1.7 [0.0] m) and control group (control, N.=11; mean [SD] age, 16.2 [1.2] years, weight 61.6 [7.3] kg and height 1.7 [0.0] m). The EG participated in an in-season 8-week PC ST program (twice/week). Participants in the CG…