Search results for "randomized"
showing 10 items of 2323 documents
Clinico-Biomechanical Issues and Dynamic Stabilization When Considering Stem Cell Treatment for Degenerative Disc Disease
2013
After reading the article published in Transplantation (1), scientists are to be congratulatedVespecially with the clinical results as published. Looking for alternatives to avoid fusion is part of function-preserving spine care, as it should be the last option to be undertaken while keeping the debate open (2, 3). Nevertheless, we would like to point out some questions that arise from a clinical point of view from our daily surgical practice. First, several clinical presentations and procedures are compared without taking into account that they are different treatments applied for different disc disease situations (discectomy is performed for disc herniation with radicular symptoms, disc p…
Comparing motivational, self-regulatory and habitual processes in a computer-tailored physical activity intervention in hospital employees - protocol…
2017
Abstract Background Most people do not engage in sufficient physical activity to confer health benefits and to reduce risk of chronic disease. Healthcare professionals frequently provide guidance on physical activity, but often do not meet guideline levels of physical activity themselves. The main objective of this study is to develop and test the efficacy of a tailored intervention to increase healthcare professionals’ physical activity participation and quality of life, and to reduce work-related stress and absenteeism. This is the first study to compare the additive effects of three forms of a tailored intervention using different techniques from behavioural theory, which differ accordin…
Adjuvant anastrozole versus exemestane versus letrozole, upfront or after 2 years of tamoxifen, in endocrine-sensitive breast cancer (FATA-GIM3): a r…
2018
Background: Uncertainty exists about the optimal schedule of adjuvant treatment of breast cancer with aromatase inhibitors and, to our knowledge, no trial has directly compared the three aromatase inhibitors anastrozole, exemestane, and letrozole. We investigated the schedule and type of aromatase inhibitors to be used as adjuvant treatment for hormone receptor-positive early breast cancer. Methods: FATA-GIM3 is a multicentre, open-label, randomised, phase 3 trial of six different treatments in postmenopausal women with hormone receptor-positive early breast cancer. Eligible patients had histologically confirmed invasive hormone receptor-positive breast cancer that had been completely remov…
Effects of l-Carnitine in Patients with Autism Spectrum Disorders: Review of Clinical Studies
2019
Carnitine is an amino acid derivative, which plays several important roles in human physiology, in the central nervous system, and for mitochondrial metabolism, in particular. Altered carnitine metabolic routes have been associated with a subgroup of patients with autism spectrum disorders (ASD) and could add to the pathophysiology associated with these disorders. We review the current evidence about the clinical effects of carnitine administration in ASD in both non-syndromic forms and ASD associated with genetic disorders. Two randomized clinical trials and one open-label prospective trial suggest that carnitine administration could be useful for treating symptoms in non-syndromic ASD. Th…
Effects of exercise and diet interventions on obesity-related sleep disorders in men: study protocol for a randomized controlled trial.
2013
Abstract Background Sleep is essential for normal and healthy living. Lack of good quality sleep affects physical, mental and emotional functions. Currently, the treatments of obesity-related sleep disorders focus more on suppressing sleep-related symptoms pharmaceutically and are often accompanied by side effects. Thus, there is urgent need for alternative ways to combat chronic sleep disorders. This study will investigate underlying mechanisms of the effects of exercise and diet intervention on obesity-related sleep disorders, the role of gut microbiota in relation to poor quality of sleep and day-time sleepiness, as well as the levels of hormones responsible for sleep-wake cycle regulati…
Recommendations for the management of patients with aneurysmal subarachnoid hemorrhage
2005
After SAH, primary and secondary complications are frequent and often require neurosurgical interventions to avoid secondary brain damage. The authors of the present paper have summarized the available data about the treatment modalities often used for patients with SAH. The present recommendations have been developed as a neurosurgical and neuroanestesiological consensus. Evidence from prospective, randomized, double blind, placebo-controlled studies support grade A recommendations (standard) for the prophylaxis and treatment of cerebral vasospasm with oral Nimodipine in good grade patients. For intravenous Nimodipine or for oral nimodipine treatment in poor grade patients, available data …
Effect of total knee replacement surgery and postoperative 12 month home exercise program on gait parameters
2017
Abstract Objective To evaluate the effects of surgery and a postoperative progressive home exercise program on gait parameters among individuals operated with total knee arthroplasty. Design Single blinded randomized controlled trial. Subjects 108 patients (84 females, 24 males, mean age 69 years). Interventions Patients were equally randomized into an exercise group (EG) and control group (CG). The 12-months progressive home exercise program starting two months postoperatively was compared to usual care. Methods Gait analysis was performed using the Gaitrite electronic walkway system. In addition, knee extension and flexion strength were measured by a dynamometer preoperatively, and pain o…
Effects of a Rehabilitation Program on Perceived Environmental Barriers in Older Patients Recovering from Hip Fracture: A Randomized Controlled Trial
2013
Objectives. To study effects of a one-year multicomponent intervention on perceived environmental barriers in hip fracture patients.Design. Randomized controlled trial of a 12-month home-based rehabilitation aiming to improve mobility and function (ISRCTN53680197); secondary analyses.Subjects. Community-dwelling hip fracture patients on average 70 days after trauma (n=81).Methods. Assessments at baseline, 3, 6, and 12 months later included perceived entrance-related barriers (e.g., indoor/outdoor stairs, lighting, floor surfaces, and storage for mobility devices) and perceived barriers in the outdoor environment (poor street condition, hilly terrain, long-distances, and lack of resting plac…
Magnesium and health outcomes: An umbrella review of systematic reviews and meta-analyses of observational and intervention studies
2020
Purpose: To map and grade all health outcomes associated with magnesium (Mg) intake and supplementation using an umbrella review. Methods: Umbrella review of systematic reviews with meta-analyses of observational studies and randomized controlled trials (RCTs) using placebo/no intervention as control group. We assessed meta-analyses of observational studies based on random-effect summary effect sizes and their p values, 95% prediction intervals, heterogeneity, small-study effects and excess significance. For meta-analyses of RCTs, outcomes with a random-effect p value < 0.005 and a high-GRADE assessment were classified as strong evidence. Results: From 2048 abstracts, 16 meta-analyses an…
A Randomized Trial of a Schlemm's Canal Microstent with Phacoemulsification for Reducing Intraocular Pressure in Open-Angle Glaucoma
2014
Purpose To assess the safety and effectiveness of the Hydrus Microstent (Ivantis, Inc, Irvine, CA) with concurrent cataract surgery (CS) for reducing intraocular pressure (IOP) in open-angle glaucoma (OAG). Design Prospective, multicenter, randomized, single-masked, controlled clinical trial. Participants One hundred eyes from 100 patients 21 to 80 years of age with OAG and cataract with IOP of 24 mmHg or less with 4 or fewer hypotensive medications and a washed-out diurnal IOP (DIOP) of 21 to 36 mmHg. Methods On the day of surgery, patients were randomized 1:1 to undergo CS with the microstent or CS alone. Postoperative follow-up was at 1 day, 1 week, and 1, 3, 6, 12, 18, and 24 months. Wa…