Search results for "Randomized"

Clinical trials in children.

2006

Abstract Randomized controlled clinical trials are felt by the medical community to provide the best evidence. Participation in trials involves the possibility of obtaining benefits but also of suffering some risks. Those risks are often considered unacceptable for children but if clinical trials are not conducted in children, clinicians are forced to extrapolate study data from adults. In 1968 H. Shirkey termed children "therapeutic orphans" because of the lack of adequately tested and labeled drugs available in appropriate formulations. Research involving children entails specific difficulties as the need to study children of different ages, the small number of children affected by certai…

TCT-664 Twelve-Month Clinical Outcomes Comparing Biodegradable Polymer Sirolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Coronary Ste…

2018

The aim of this study is to compare the safety and efficacy of the biodegradable polymer coated sirolimus-eluting coronary stent (SES, BioMime™, Meril Life Sciences, India) with durable polymer coated everolimus-eluting coronary stent (EES, XIENCE family, Abbott Vascular, California, USA) in de

Global mapping of randomised trials related articles published in high-impact-factor medical journals: a cross-sectional analysis

2020

[Background]: Randomised controlled trials (RCTs) provide the most reliable information to inform clinical practice and patient care. We aimed to map global clinical research publication activity through RCT-related articles in high-impact-factor medical journals over the past five decades.

A systematic review on regenerative alveolar graft materials in clinical trials

2021

Abstract Background Alveolar cleft grafting is a necessary procedure to restore bone defects. Randomized clinical trials (RCTs) are regarded as a golden standard for investigating the efficacy of treatments. Nevertheless, risk of bias (RoB) can still affect the validity of these trials. We aimed to conduct a systemic review of all control trials (CTs) using regenerative materials for alveolar cleft reconstructions to evaluate their RoB and perform a meta-analysis of new bone formation. Methods Cochrane Oral Health Group's Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (PubMed), EMBASE AND Google Scholar were searched up to October 2020. Thereafter, th…

Update to the ASFA guidelines on the use of therapeutic apheresis in ANCA‐associated vasculitis

2020

Since 1986, the American Society for Apheresis (ASFA) has published practice guidelines on the use of therapeutic apheresis in the Journal of Clinical Apheresis (JCA) Special Issue. Since 2007, updated guidelines have been published every 3 years to reflect current evidence based apheresis practice with the most recent edition (8th) published in 2019. With each edition, the guidelines are reviewed and updated based on any newly published literature since the last review. The PEXIVAS study, an international, randomized controlled trial comparing therapeutic plasma exchange (TPE) vs no TPE and standard vs reduced dose steroid regimen on the primary composite outcome of end stage renal disease…

Comparison between Minimally Invasive Video-Assisted Thyroidectomy and Conventional Thyroidectomy: Is There Any Evidence-Based Information?

2008

The aim of this study was to test the hypothesis that minimally invasive video-assisted thyroidectomy (MIVAT) affords comparable safety and efficacy as to the open conventional surgery in dealing with patients with small thyroid nodules.Randomized controlled trials comparing the MIVAT with open thyroidectomy were ascertained by methodical search using Medline, Embase, Pubmed, and The Cochrane Library. Primary meta-analysis outcomes were adverse events (laryngeal nerve palsy and hypoparathyroidism), and cosmesis and secondary outcomes were operative time, blood loss, and early and late postoperative pain.Operative time was significantly less with open thyroidectomy than with MIVAT, while MIV…

Ethical reflections on Evidence Based Medicine

2013

BACKGROUND According to Potter’s point of view, medical ethics is the science of survival, a bridge between humanistic and scientific culture. The working out of judgements on right or wrong referred to the human being are studied by this science. Methodological quality is fundamental in clinical research, and several technical issues are of paramount importance in trying to answer to the final question “what is the true, the right thing?”. We know they are essential aspects as in medical ethics as in evidence based practice. AIM OF THE STUDY The aim of this paper is to talk about relationships and implications between ethical issues and Evidence Based Medicine (EBM). DISCUSSION EBM represe…

Evidenz-basierte Überprüfung der Therapieempfehlungen bei Epicondylopathia humeri lateralis (Tennisellenbogen) - eine Übersicht

2004

The guidelines of the German Orthopaedic Societies regarding the treatment of lateral elbow epicondylitis were analysed on the ground of recently published reviews or randomised placebo-controlled trials (RCT). For the acute phase, reviews or RCTs failed to show a clinical effect beyond placebo if follow-up was extended over 6 weeks. For the chronic phase a current Cochrane review failed to identify any controlled trial regarding surgical procedures during the last decades. Without an adequate control group, it is not possible to draw any meaningful conclusions about the value of this modality of treatment. Therefore surgery is not indicated before repetitive low-energy extracorporeal shock…

Prevention of Sports Injuries

2007

Increased participation in sports has led to more sports injuries. Evidence-based methods to prevent sports injuries are needed. A systematic review was conducted of the effects of randomized controlled interventions to prevent sports injuries. A systematic search was performed of various databases and the reference lists of articles and reviews. Two reviewers independently extracted the data and assessed the methodological quality of the included trials. Thirty-two trials (24,931 participants) met the inclusion criteria. We found evidence of the preventive effect of 3 types of injury prevention interventions. In 5 trials including 6 different comparisons (2446 participants), custom-made or…

2021

ObjectiveTo assess the safety and efficacy of epigallocatechin-3-gallate (EGCG) add-on to glatiramer acetate (GA) in patients with relapsing-remitting multiple sclerosis (RRMS).MethodsWe enrolled patients with RRMS (aged 18–60 years, Expanded Disability Status Scale [EDSS] score 0–6.5), receiving stable GA treatment in a multicenter, prospective, double-blind, phase II, randomized controlled trial. Participants received up to 800 mg oral EGCG daily over a period of 18 months. The primary outcome was the proportion of patients without new hyperintense lesions on T2-weighted (T2w) brain MRI within 18 months. Secondary end points included additional MRI and clinical parameters. Immunologic eff…