Contemporary clinical trials
-
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.
-
Contemp Clin Trials · Mar 2015
Neurodevelopment of children exposed to anesthesia: design of the Mayo Anesthesia Safety in Kids (MASK) study.
There is increasing evidence that exposure of developing brains in animals, including nonhuman primates, to commonly-utilized anesthetic agents may cause adverse effects on cognition and behavior. In this paper, we summarize our methodology for a population-based, propensity-matched study to evaluate possible anesthesia-related sequelae in preschool children when evaluated in elementary or high school. A cohort of all children born in Olmsted County, Minnesota between the years 1994 and 2007 who are currently local residents has been identified. ⋯ Selected children are invited to participate in a single 4-hour session of neuropsychological testing, including the National Center for Toxicological Research-Operant Test Battery, which has been used to study anesthetic neurotoxicity in nonhuman primates. The results of this testing will be compared among children with different anesthetic exposure histories. The expected products of this research will be a detailed phenotype of possible anesthetic-associated neurotoxicity in humans, utilizing a robust patient database and neuropsychological testing battery, and the first comparison of effects of anesthetic exposure in children and nonhuman primates performing nearly identical behavioral tasks.
-
Contemp Clin Trials · Mar 2015
Payment expectations for research participation among subjects who tell the truth, subjects who conceal information, and subjects who fabricate information.
Multiple models guide researchers' payment practices but few studies have assessed subjects' expectations for payment. Payments in excess of subjects' expectations may result in undue inducement, while payments below these expectations may be associated with exploitation. Data on subjects' payment expectations will help inform practices to avoid undue inducement and exploitation. ⋯ Although subjects expect greater payments for more risky procedures, ethical considerations for limiting undue inducement may prevent researchers from meeting subjects' expectations. Subjects who use deceptive practices appear to be more risk-tolerant than subjects who deny using deception; nonetheless, these deceptive subjects also exercise some risk aversion when they refuse higher-risk procedures. These subjects may be able to protect themselves from undue inducement by refusing procedures that exceed their risk tolerance.
-
Contemp Clin Trials · Mar 2015
Randomized Controlled TrialRationale and design of a randomized double-blind clinical trial in breast cancer: dextromethorphan in chemotherapy-induced peripheral neuropathy.
Anti-cancer chemotherapy often induces peripheral neuropathy and consequent cognitive and quality of life impairment. Guidelines recommend antiepileptics or antidepressants but their efficacy is limited.Dextromethorphan, a N-methyl-D-aspartate receptor antagonist, has shown its efficacy in painful diabetic neuropathy and in post-operative pain but has not been studied in chemotherapy-induced peripheral neuropathy. This clinical trial evaluates the effect of dextromethorphan on pain, cognition and quality of life in patients who suffer from neuropathic pain induced by chemotherapy for breast cancer. It also assesses the impact of dextromethorphan genetic polymorphism on analgesia. ⋯ Considering the poor efficacy of available drugs in chemotherapy-induced neuropathic pain, dextromethorphan may be a valuable therapeutic option. Pharmacogenetics may provide predictive factors of dextromethorphan response in patients suffering from breast cancer.