Global posture reeducation compared with segmental muscle stretching exercises in the treatment of fibromyalgia: a randomized controlled trial
ConclusionsMuscle stretching exercises based on global posture reeducation and segmental muscle stretching exercises, both used in concert with an educational approach rooted in cognitive behavioral therapy, reduced the pain intensity and impact of FM on quality of life. These exercises also improved FM patients ’ pain threshold at tender points, attitudes toward chronic pain, and postural control. There were no differences between global posture reeducation and segmental muscle stretching exercises.Trial registrationClinicalTrials.govNCT02384603. Registered on 10 March 2015. (Source: Trials)
Source: Trials - June 7, 2023 Category: Research Source Type: clinical trials
More efficient and inclusive time-to-event trials with covariate adjustment: a simulation study
AbstractAdjustment for prognostic covariates increases the statistical power of randomized trials. The factors influencing the increase of power are well-known for trials with continuous outcomes. Here, we study which factors influence power and sample size requirements in time-to-event trials. We consider both parametric simulations and simulations derived from the Cancer Genome Atlas (TCGA) cohort of hepatocellular carcinoma (HCC) patients to assess how sample size requirements are reduced with covariate adjustment. Simulations demonstrate that the benefit of covariate adjustment increases with the prognostic performance...
Source: Trials - June 6, 2023 Category: Research Source Type: clinical trials
Effect of pelvic floor muscle training on reports of urinary incontinence in obese women undergoing a low-calorie diet before bariatric surgery — protocol of a randomized controlled trial
AbstractBackgroundObesity represents a growing threat to health with multiple negative impacts including urinary incontinence. Pelvic floor muscle training (PFMT) is the first line of treatment for urinary incontinence. Both surgical and conservative weight loss results in improvement of urinary incontinence reports in obese women and we hypothesize that a low-calorie diet in combination with PFMT would result in additional beneficial effects to urinary symptoms in women with UI compared would with weight loss alone.ObjectiveTo assess the effect of a low-calorie diet plus PFMT protocol in obese women ’s urinary incontine...
Source: Trials - June 5, 2023 Category: Research Source Type: clinical trials
Cross-sectional analysis characterizing the use of rank preserving structural failure time in oncology studies: changes to hazard ratio and frequency of inappropriate use
ConclusionsRPSFT is a common tactic used by the industry to reinterpret trial results. Nineteen percent of RPSFT use is appropriate. We recognize that while crossover can bias OS results, the allowance and handling of crossover in trials should be limited to appropriate circumstances. (Source: Trials)
Source: Trials - June 3, 2023 Category: Research Source Type: clinical trials
Transnasal Humidified Rapid Insufflation Ventilatory Exchange in children requiring emergent intubation (Kids THRIVE): a statistical analysis plan for a randomised controlled trial
AbstractThe placement of an endotracheal tube for children with acute or critical illness is a low-frequency and high-risk procedure, associated with high rates of first-attempt failure and adverse events, including hypoxaemia. To reduce the frequency of these adverse events, the provision of oxygen to the patient during the apnoeic phase of intubation has been proposed as a method to prolong the time available for the operator to insert the endotracheal tube, prior to the onset of hypoxaemia. However, there are limited data from randomised controlled trials to validate the efficacy of this technique in children. The techn...
Source: Trials - May 31, 2023 Category: Research Source Type: clinical trials
Research and Pipeline Pfizer Announces Positive Marstacimab Results from Pivotal Phase 3 Hemophilia A and B Trial
Study demonstrates statistically significant and clinically relevant reduction in annualized bleeding rate compared to prophylaxis and on-demand intravenous regimens
Marstacimab, if approved, has the potential to become the first once-weekly... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - May 30, 2023 Category: Pharmaceuticals Source Type: clinical trials
Biomarker-guided duration of antibiotic treatment in children hospitalised with confirmed or suspected bacterial infection: statistical analysis plan for the BATCH trial and PRECISE sub-study
ConclusionWe describe the statistical analysis plan for the BATCH trial and PRECISE sub-study, including definitions of clinical outcomes, reporting guidelines, statistical principles, and analysis methods. The trial uses a design with co-primary superiority and non-inferiority endpoints. The analysis plan has been written prior to the completion of follow-up.Trial registrationBATCH: ISRCTN11369832, registered 20 September 2017, doi.org/10.1186/ISRCTN11369832.PRECISE: ISRCTN14945050, registered 17 December 2020, doi.org/10.1186/ISRCTN14945050. (Source: Trials)
Source: Trials - May 30, 2023 Category: Research Source Type: clinical trials
Effect of continuous measurement and adjustment of endotracheal tube cuff pressure on postoperative sore throat in patients undergoing gynecological laparoscopic surgery: study protocol for a randomized controlled trial
This study is a single-center, randomized, parallel-controlled, superiority trial with a 1:1 allocation ratio. Sixty patients whose age is between 18 and 65 years and scheduled for gynecological laparoscopic surgery will be randomized to the cuff pressure measurement and adjustment (CPMA) group and the only cuff pressure measurement without adjustment group (control group). The primary endpoint is the incidence of sore throat at rest within 24 h afte r extubation. The secondary endpoints include the incidence of cough, the incidence of hoarseness, the incidence of postoperative nausea and vomiting (PONV), POST, and pain...
Source: Trials - May 27, 2023 Category: Research Source Type: clinical trials
A Study of Prevalence and Clinical Characteristics of Tic Disorders in Children at Sohag University Hospital
Condition: Tic Disorder, Childhood Intervention: Diagnostic Test: Diagnostic and Statistical Manual of mental disorder- fifth edition ( DSM5) Sponsor: Sohag University Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - May 25, 2023 Category: Research Source Type: clinical trials
