Search results for "Randomized Controlled Trial"
showing 10 items of 2199 documents
THE OPTIMIZATION OF INTERFERON FOR MS STUDY: 375 MICROG INTERFERON BETA-1B IN SUBOPTIMAL RESPONDERS.
2008
We aimed to evaluate the safety and MRI efficacy of interferon beta-1b (IFNbeta-1b) 375 microg (subcutaneously [sc] every other day [eod]) in relapsing-remitting multiple sclerosis (RRMS) patients with a suboptimal response to IFNbeta-1b 250 microg, i.e., with MRI activity or relapses. The OPTimization of Interferon for MS (OPTIMS) study was a prospective multicenter randomized phase 2 trial comprising a 6-month run-in phase (to identify suboptimal responders) and a 6-month randomized phase of open-label clinical and blinded MRI follow-up. During run-in all patients were treated with IFNbeta-1b 250 microg sc eod; during the study phase suboptimal treatment responders were randomized either …
The effect of prenatal lifestyle intervention on weight retention 12 months postpartum: results of the Norwegian Fit for Delivery randomised controll…
2015
Objective To examine the effect of a prenatal lifestyle intervention on postpartum weight retention (PPWR). Design Randomised controlled trial. Setting Healthcare clinics in southern Norway. Population Healthy, nulliparous women with body mass index ≥19 kg/m2 , age ≥18 years, and singleton pregnancy of ≤20 gestational weeks. Methods Women were randomised to intervention (dietary counselling twice by phone and access to twice-weekly exercise groups during pregnancy) or control group (standard prenatal care). Intervention compliance was defined post-factum as attending dietary counselling and ≥14 exercise classes. Main outcome measures PPWR (weight measured postpartum minus self-reported pre-…
How does a lifestyle intervention during pregnancy influence perceived barriers to leisure-time physical activity? The Norwegian fit for delivery stu…
2018
Abstract Background To develop effective health promotional and preventive prenatal programs, it is important to understand perceived barriers to leisure-time physical activity during pregnancy, including exercise and sport participation. The aims of the present study was 1) to assess the effect of prenatal lifestyle intervention on the perceived barrier to leisure-time physical activity during pregnancy and the first year after delivery and 2) identify the most important perceived barriers to leisure-time physical activity at multiple time points during and after pregnancy. Methods This secondary analysis was part of the Norwegian Fit for Delivery study, a combined lifestyle intervention e…
Equivalence of the 3-month and 28-day formulations of triptorelin with regard to achievement and maintenance of medical castration in women with endo…
2003
OBJECTIVE: The present study aims at demonstrating the equivalence of the 28-day and 3-month formulations of triptorelin SR (sustained release) in terms of percentage of patients achieving castration levels of estradiol (<==50 pg/mL) 84 days after treatment initiation. DESIGN: A phase II, prospective, randomized, multicenter, open study was conducted in two parallel groups of women with endometriosis. SETTING: Academic hospitals. PATIENT(S): Seventy-two women with endometriosis. were treated with a single intramuscular injection of 3-month triptorelin SR, and 74 patients were treated with one intramuscular injection of 28-day triptorelin SR every 28 days for 3 months. INTERVENTION(S): As pa…
Ulipristal acetate versus leuprolide acetate for uterine fibroids
2012
A b s t r ac t Background The efficacy and side-effect profile of ulipristal acetate as compared with those of leuprolide acetate for the treatment of symptomatic uterine fibroids before surgery are unclear. Methods In this double-blind noninferiority trial, we randomly assigned 307 patients with symptomatic fibroids and excessive uterine bleeding to receive 3 months of daily therapy with oral ulipristal acetate (at a dose of either 5 mg or 10 mg) or once-monthly intramuscular injections of leuprolide acetate (at a dose of 3.75 mg). The primary outcome was the proportion of patients with controlled bleeding at week 13, with a prespecified noninferiority margin of −20%. Results Uterine bleed…
Effects of a non-pharmacological approach for chronic pain management in patients with haemophilia: efficacy of cognitive-behavioural therapy associa…
2021
INTRODUCTION More than half of adult patients with severe haemophilia (PWH) suffer pain daily, with chronic pain (CP) in more than 15% of cases, thereby reducing their quality of life (QoL). However, there are no evidence-based therapeutic guidelines for pain management. AIM To evaluate the effectiveness of a combined protocol based on psychology and physiotherapy in the improvement of CP self-efficacy in PWH with CP. Secondary outcomes are changes in QoL, emotional status, pain and kinesiophobia. METHODS In this prospective controlled trial study, recruited patients were allocated either to an experimental group (EG, n = 10) or to a control group (CG, n = 9). EG received interventions over…
Resectoscope versus small diameter hysteroscopy for endometrial polypectomy in patients with "unfavorable" cervix
2017
BACKGROUND: The aim of this study was to compare resectoscopic and small-diameter hysteroscopic techniques for endometrial polypectomy in patients with "unfavorable" cervix.METHODS: Eighty women with a single 2-4 cm sized endometrial polyp, with unfavorable cervical anatomical conditions were enrolled in the study. Forty patients were treated with a 26F resectoscope requiring cervical dilatation (group A), forty patients were treated with a 5-mm hysteroscope requiring vaginoscopic approach (group B). Operative time, fluid absorption, complications, instrument failure, postoperative pain, overnight stay were analyzed. Operative visualization, operative difficulty and overall surgeon's satisf…
Cizolirtine Citrate, an Effective Treatment for Symptomatic Patients with Urinary Incontinence Secondary to Overactive Bladder: A Pilot Dose-Finding …
2009
Abstract Background A dose-finding study was performed as the first step in the clinical development of the new drug, cizolirtine citrate. Objective To assess the efficacy and safety of cizolirtine citrate in overactive bladder with urinary incontinence. Design, setting, and participants Seventy-nine outpatients with clinical overactive bladder and/or urodynamic diagnosis of detrusor overactivity were randomized in a multicentre, 12-wk, double-blind, pilot trial. Interventions Patients received cizolirtine citrate 400mg bid (C400), cizolirtine citrate 200mg bid (C200), or placebo. Measurements Patients recorded efficacy variables in 7- and 14-d bladder diaries: urinary incontinence episodes…
Effects of a HIIT Protocol on Cardiovascular Risk Factors in a Type 1 Diabetes Mellitus Population
2021
Cardiovascular complications are important causes of morbidity and mortality of Type 1 Diabetes Mellitus (T1DM) people. Regular exercise is strongly recommended to these patients due to its preventive action against this type of disease. However, a large percentage of patients with T1DM people present a sedentary behavior, mainly, because of the fear of a post-exercise hypoglycemia event and lack of time. High-intensity interval training (HIIT) is an efficient and safe methodology since it prevents hypoglycemia and does not require much time, which are the main barriers for this population to doing exercise and increasing physical conditioning. Nineteen sedentary adults (37 ± 6.5 years) wit…
Pharmacological interventions for somatoform disorders in adults
2014
BACKGROUND: Somatoform disorders are characterised by chronic, medically unexplained physical symptoms (MUPS). Although different medications are part of treatment routines for people with somatoform disorders in clinics and private practices, there exists no systematic review or meta-analysis on the efficacy and tolerability of these medications. We aimed to synthesise to improve optimal treatment decisions.OBJECTIVES: To assess the effects of pharmacological interventions for somatoform disorders (specifically somatisation disorder, undifferentiated somatoform disorder, somatoform autonomic dysfunction, and pain disorder) in adults.SEARCH METHODS: We searched the Cochrane Depression, Anxi…