Contemporary clinical trials
-
Contemp Clin Trials · May 2015
Randomized Controlled TrialMenstrual pain and quality of life in women with primary dysmenorrhea: Rationale, design, and interventions of a randomized controlled trial of effects of a treadmill-based exercise intervention.
Dysmenorrhea in the absence of pelvic abnormality is termed primary dysmenorrhea (PD). The health burden and social and economic costs of PD are high as it is reported to be the leading cause of recurrent absenteeism from school or work in adolescent girls and young adults. The belief that exercise works for relieving symptoms in women with PD is based on anecdotal evidence and non-experimental studies. ⋯ The secondary outcomes of the study are quality of life, functional limitation, sleep, global improvement with treatment, and protocol adherence. The outcomes assessments are done at first menstrual period (baseline, Week 0), 2nd menstrual period (Week 4) and at two additional time points (Week 16 and Week 28) during the trial. The results of the study will provide physiotherapists, medical practitioners, and researchers as well as the women who have PD with new insights, knowledge, and evidence about the use of exercise to manage pain in women with PD.
-
Contemp Clin Trials · May 2015
Meta AnalysisA multilevel approach to network meta-analysis within a frequentist framework.
Meta-analysis is a powerful tool to summarize knowledge. Pairwise or network meta-analysis may be carried out with multivariate models that account for the dependence between treatment estimates and quantify the correlation across studies. From a different perspective, meta-analysis may be viewed as a special case of multilevel analysis having a hierarchical data structure. ⋯ Finally, we compare the results from our approach with those from a Bayesian network meta-analysis on a binary endpoint which examines the effect on mortality of some anesthetics at the longest follow-up available. In addition, we compare results from the Bayesian and multilevel network meta-analysis approaches on a publicly available "Thrombolytic drugs" database. We also provide the reader with a blueprint of SAS codes for fitting the proposed models, although our approach does not rely on any specific software.
-
Contemp Clin Trials · May 2015
Randomized Controlled TrialDoes cognitive behavioral therapy strengthen the effect of bariatric surgery for obesity? Design and methods of a randomized and controlled study.
(Extreme) obesity is a chronic harmful condition with high risk of medical comorbidities and negative social and emotional consequences. Bariatric surgery is an effective intervention for obesity, but approximately 20 to 30% of the patients experience adverse outcomes after surgery and there is a need for augmentation of current treatment strategies. This study examines the added value of pre-operative cognitive behavioral therapy (CBT) focused on modification of thoughts and behaviors in terms of eating behavior and physical exercise as well as preparation for surgery and postoperative life style. We hypothesize that pre-operative CBT will result in better weight loss maintenance, reduction of maladaptive eating behavior and better adherence to postoperative lifestyle on the long term as compared to bariatric surgery alone. ⋯ One hundred and twenty eight patients that are on a waiting list for bariatric surgery are randomly assigned to the control or treatment condition. Patients in the treatment condition receive 10 sessions of CBT before surgery aimed at modifying dysfunctional eating habits and behaviors and developing more rational weight and body-related beliefs in order to enable long term maintenance of a healthier lifestyle after surgery. Weight loss, eating behavior, eating disorders, depression, quality of life and psychological distress are assessed before and after treatment, as well as 1, 3, and 5 year following surgery.
-
Contemp Clin Trials · May 2015
PROMIS--Prostate MR imaging study: A paired validating cohort study evaluating the role of multi-parametric MRI in men with clinical suspicion of prostate cancer.
Transrectal ultrasound-guided prostate biopsies are prone to detection errors. Multi-parametric MRI (MP-MRI) may improve the diagnostic pathway. ⋯ PROMIS will determine whether MP-MRI of the prostate prior to first biopsy improves the detection accuracy of clinically-significant cancer.