Search results for "Randomization"
showing 10 items of 148 documents
Effect of oral magnesium supplementation on physical performance in healthy elderly women involved in a weekly exercise program: A randomized control…
2014
Background: Magnesium deficiency is associated with poor physical performance, but no trials are available on how magnesium supplementation affects elderly people’s physical performance. Objective: The aim of our study was to investigate whether 12 wk of oral magnesium supplementation can improve physical performance in healthy elderly women. Design: In a parallel-group, randomized controlled trial, 139 healthy women (mean 6 SD age: 71.5 6 5.2 y) attending a mild fitness program were randomly allocated to a treatment group (300 mg Mg/d; n = 62) or a control group (no placebo or intervention; n = 77) by using a computer-generated randomization sequence, and researchers were blinded to their …
Ezetimibe/Simvastatin 10/20 mg Versus Rosuvastatin 10 mg in High Risk Hypercholesterolemic Patients Stratified by Previous Statin Treatment Potency
2010
Objective: This post-hoc analysis compared the lipid-altering efficacy of Ezetimibe/Simvastatin 10/20 mg (EZ/Simva) versus Rosuvastatin 10 mg (Rosuva) in patients stratified by statin potency/dose prior to randomization. Methods: Patients with elevated low-density lipoprotein cholesterol (LDL-C) despite prior statin treatment (n = 618) were randomized 1:1 to EZ/Simva 10/20 mg or Rosuva 10 mg for 6 weeks. Percent change from baseline in lipids and attainment of lipid targets were assessed within each subgroup (low potency n = 369, high potency n = 249). Consistency of the treatment effect across subgroups was evaluated by testing for treatment-by-subgroup interaction. No multiplicity adjustm…
A parent motivational interviewing program for dental care in children of a rural population.
2014
Objectives: To determine the effectiveness of a motivational interviewing-based educational program in reducing the number and intensity of new caries and bacterial dental plaque levels at 6 months post randomization. Study Design: A randomized and single blind clinical trial in 100 schoolchildren between 6-10 years of age presenting the highest risk score of caries according to the Caries Management by Risk Assessment (CAMBRA) criteria was performed. These patients were randomized to two groups: control (in which the mothers initially received an oral prevention informative session) and experimental (in which the mothers received the initial informative session, followed by individual moti…
A meta-review of “lifestyle psychiatry”: the role of exercise, smoking, diet and sleep in the prevention and treatment of mental disorders
2020
There is increasing academic and clinical interest in how "lifestyle factors" traditionally associated with physical health may also relate to mental health and psychological well-being. In response, international and national health bodies are producing guidelines to address health behaviors in the prevention and treatment of mental illness. However, the current evidence for the causal role of lifestyle factors in the onset and prognosis of mental disorders is unclear. We performed a systematic meta-review of the top-tier evidence examining how physical activity, sleep, dietary patterns and tobacco smoking impact on the risk and treatment outcomes across a range of mental disorders. Result…
Effects of a workplace physical exercise intervention on the intensity of low back symptoms in office workers: A cluster randomized controlled cross-…
2006
Objectives. The purpose of the study was to examine the effects of a workplace physical exercise intervention on the intensity of low back symptoms. Methods. The study was a cluster randomized controlled trial with department (n = 4) as the unit of randomization. The subjects were office workers [(n = 36), mean age 47.1 (SD 8.4) years] who self-reported low back symptoms, which restricted their daily activities during the last 12 months. Low back symptoms were measured using the Borg CR10 scale. The cross-over design consisted of one intervention period of light resistance training and guidance and no training and no guidance of 15 weeks duration. Statistical analyses were based on linear m…
Reducing the initial number of rituximab maintenance-therapy infusions for ANCA-associated vasculitides: randomized-trial post-hoc analysis
2020
AbstractObjectiveThe randomized, controlled MAINRITSAN2 trial was designed to compare the capacity of an individually tailored therapy [randomization day 0 (D0)], with reinfusion only when CD19+ lymphocytes or ANCA had reappeared, or if the latter’s titre rose markedly, with that of five fixed-schedule 500-mg rituximab infusions [D0 + D14, then months (M) 6, 12 and 18] to maintain ANCA-associated vasculitis (AAV) remissions. Relapse rates did not differ at M28. This ancillary study was undertaken to evaluate the effect of omitting the D14 rituximab infusion on AAV relapse rates at M12.MethodsMAINRITSAN2 trial data were subjected to post-hoc analyses of M3, M6, M9 and M12 relapse-free surviv…
Single Preoperative Oral Application of Ascorbic Acid Does Not Affect Postoperative Plasma Levels of Ascorbic Acid
2002
<i>Background and Aims:</i> A decrease in ascorbic acid (AA) plasma concentration is well known during the postoperative period and postulated to be caused by increased radical scavenging activity in response to surgical trauma. This often affects postoperative patients and is associated with multiple organ failure. Therefore, substitution of AA could potentially decrease the risk of postoperative complications. This study examines the effect of preoperative oral administration of 1,000 mg AA on the postoperative AA plasma concentration. <i>Methods:</i> 54 patients were randomly split into two groups; patients in group 1 received no AA preoperatively while group 2 re…
High-Dose Therapy and Autologous Hematopoietic Stem Cell Transplantation (ASCT) Has a Significant but Transient Impact on Quality of Life: Lessons Fr…
2011
Abstract Abstract 1989 Objective: High-dose therapy (HDT) and ASCT is the standard of care in a variety of hematologic malignancies. Whereas for some indications a survival advantage for HDT and ASCT has been demonstrated, a benefit only in terms of better progression-free survival has been shown for CLL. Because of this the quality of life (QoL) deserves particular attention. QoL assessment was a major focus of a randomized controlled EBMT-Intergroup trial on the value of HDT compared to observation in first or second remission of CLL (Michallet, Blood, 2011). Methods: 222 patients were enrolled into the study and allocated to either ASCT or observation. In the transplant arm, 72% received…
Retraction and Republication: Primary Prevention of Cardiovascular Disease with a Mediterranean Diet. N Engl J Med 2013;368:1279-90.
2018
To the Editor: Because of irregularities in the randomization procedures, we wish to retract the following article: Primary Prevention of Cardiovascular Disease with a Mediterranean Diet. N Engl J Med 2013;368:1279-90. DOI: 10.1056/NEJMoa1200303.1 We have reanalyzed the data and have published a new report: Primary Prevention of Cardiovascular Disease with a Mediterranean Diet Supplemented with Extra-Virgin Olive Oil or Nuts. N Engl J Med. DOI: 10.1056/NEJMoa1800389.2 . . .
Analgesics for Dental Implants: A Systematic Review
2021
Postsurgical pain is commonly associated with dental and oral surgery, and the use of analgesics has been investigated in the management of postoperative pain. This systematic review summarizes available evidence on analgesics used to manage dental implant surgery postoperative pain, to identify best therapeutic protocols and knowledge gap. A comprehensive search was conducted including MEDLINE/Pubmed, EMBASE, SCOPUS, clinicaltrials.gov, and the Cochrane Database of Systematic Reviews through May 2020. Only randomized controlled trials were included. PRISMA guidelines were followed, and risk of bias was appraised using Cochrane RoB2 tool. Eleven trials (762 patients overall) were included. …