Search results for "randomized controlled trial"

The Association of Basal Insulin Glargine and/or n-3 Fatty Acids With Incident Cancers in Patients With Dysglycemia

2014

OBJECTIVE Epidemiologic studies linking insulin glargine and glucose-lowering therapies to cancers and n-3 fatty acids to cancer prevention have not been confirmed. We aimed to assess the effect of insulin glargine and n-3 fatty acids on incident cancers within the context of the ORIGIN (Outcome Reduction with Initial Glargine Intervention) trial. RESEARCH DESIGN AND METHODS The ORIGIN trial is an international, long-term, randomized two-by-two factorial study comparing insulin glargine with standard care and n-3 fatty acids with placebo (double blind) in people with dysglycemia at high risk for cardiovascular events. The primary outcome measure (cancer substudy) was the occurrence of any …

Effects of high-impact training and detraining on femoral neck structure in premenopausal women: a hip structural analysis of an 18-month randomized …

2013

Purpose: This study evaluated the training effects of an 18-month exercise intervention and subsequent 3.5-year follow-up on femoral neck structure in premenopausal women. Methods: Of 98 women who participated in this randomized controlled study, 84 (39 trainees and 45 controls) completed the 18-month intervention. At both 18 months and 3.5 years, dual-energy X-ray absorptiometry data on 22 trainees and 22 control participants (ages 35–45 y) were available for hip structural analysis. The section modulus (Z), cross-sectional area (CSA), and subperiosteal width at the femoral neck were analyzed. Lower-leg explosive power and estimated maximal oxygen uptake (Vo2max) were assessed by vertical…

IVIG in APS pregnancy

2004

For more than two decades, the intravenous administration of high doses of IgG pooled from the plasma of healthy donors (immune globulin therapy, also known as ‘IVIG’) has benefited patients with a variety of autoimmune disorders. A potential therapeutic role of IVIG in the prevention of thrombosis and of miscarriages in antiphospholipid syndrome (APS) has been postulated. Multicenter randomized controlled trials attempted to define the role of IVIG in preventing pregnancy complications in APS indicate that simple anticoagulation could not be completely satisfactory, and certain patient subgroups might take advantage of IVIG therapy alone or in combination with heparin.

Definitive Abutments Placed at Implant Insertion and Never Removed: Is It an Effective Approach? A Systematic Review and Meta-Analysis of Randomized …

2017

Purpose To assess whether repeated abutment disconnections and reconnections have any impact on peri-implant bone resorption and soft tissue healing. Materials and Methods Electronic and manual searches were conducted for English-language articles published up to March 2017 that identified a relation between repeated disconnections of implant abutments (PA group) and prosthetic or implant failures, complications, marginal bone loss (MBL), soft tissue healing, and esthetic evaluation (pink esthetic score [PES]) after at least 1 year of function compared with implants receiving a final abutment at the time of implant placement (DA group). Results Fourteen articles (535 patients with 994 impla…

Effects of Exercise on Health-Related Quality of Life and Fear of Falling in Home-Dwelling Older Women

2012

This randomized, controlled trial evaluated the effects of exercise on health-related quality of life (HRQoL) and fear of falling (FoF) among 149 home-dwelling older women. The 12-mo exercise program was intended to reduce the risk of falls and fractures. HRQoL was assessed by the RAND-36 Survey, and FoF, with a visual analog scale, at baseline, 12 mo, and 24 mo. On all RAND-36 scales, the scores indicated better health and well-being. The exercise had hardly any effect on HRQoL; only the general health score improved slightly compared with controls at 12 mo (p = .019), but this gain was lost at 24 mo. FoF decreased in both groups during the intervention with no between-groups difference at…

Outcome comparison among working adults with centralizing low back pain: Secondary analysis of a randomized controlled trial with 1-year follow-up

2009

Our purpose was to examine if adults with centralizing pain might achieve better treatment outcomes when treated by individually designed therapy than “given advice only to stay active”. One hundred and nineteen working adults with first or a recurrent episode of low back pain (LBP) were classified as centralizers and were randomly allocated to orthopaedic manual therapy (OMT; n=42), the McKenzie (n=48) or “advice only to stay active” (Advice-only; n=29) groups. Back and leg pain were assessed by the visual analogue scale, disability with the Roland–Morris questionnaire and functional status with an activities of daily living (ADL) index. Immediately after the treatment period, LBP decrease…

2020

Healthy aging is associated with deficits in focused and sustained attention and executive functions. However, cognitive training (CT) provides a promising method to counteract these deficits. In the present randomized controlled study, we examined to what extent CT regimes can improve attention, verbal skills, and inhibition capacities. Over a period of 16 weeks, healthy older adults (65 years and older, mean: 70 years) received a trainer-guided multidomain paper-and-pencil and computerized CT. Pre- and post-training, a battery of psychometric tests was applied that measured the critical functions. This study used two control groups: a passive control and an active control group performing…

The effect of off-pump coronary artery bypass on mortality after acute coronary syndrome: A meta-analysis

2012

Background Patients requiring surgical revascularisation for acute coronary syndrome (ACS) form a clinically heterogeneous group ranging from haemodynamic stability to cardiogenic shock. Whilst 'off-pump' revascularisation (OPCAB) is often considered, patient selection and operative timing remain controversial. This study aims to identify whether OPCAB may confer a mortality benefit over ONCAB in revascularisation for ACS. Secondly, we review the impact of OPCAB on completeness of revascularisation (CR) and long-term re-intervention. Methods A systematic literature review identified 9 studies (1 randomised controlled trial) of which 8 fulfilled criteria for meta-analysis. Outcomes for a tot…

Randomized, placebo-controlled, double-blind and open-label studies in the treatment and prevention of acute diarrhea with Enterococcus faecium SF68

2020

Enterococcus faecium SF68® (SF68) is a licensed pharmaceutical for treatment and prevention of diarrhea in Austria, Italy and Switzerland. However, as for other probiotics, evidence for its efficacy is based on small to medium-sized studies. Four unpublished studies on the treatment of acute diarrhea and the prevention of antibiotic-associated diarrhea were analyzed: one randomized, double blind, placebo-controlled trial (RCT) for treatment (n = 1,143), one open-label study for treatment (n = 5,093), one RCT for prevention (n = 1,397) and one open-label study for prevention (n = 4,340). Patients in the treatment-arm and the open-label studies received SF68 (b.i.d. for the prevention studies…

Low-dose rivaroxaban and aspirin among patients with peripheral artery disease: a meta-analysis of the COMPASS and VOYAGER trials.

2021

Abstract Aims Peripheral artery disease (PAD) patients suffer a high risk of major cardiovascular (CV) events, with athero-thrombo-embolism as the underlying pathophysiologic mechanism. Recently, two large randomized clinical trials evaluated the efficacy and safety of low-dose rivaroxaban twice daily plus aspirin in stable PAD outpatients and those immediately after peripheral revascularization. We sought to determine if the effects of low-dose rivaroxaban and aspirin compared to aspirin alone are consistent across this broad spectrum of PAD patients. Methods and results We conducted a random-effects meta-analysis of the COMPASS and VOYAGER randomized trials among 11 560 PAD patients (4996…