Search results for "Single-Blind Method"
showing 10 items of 163 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 …
Semaglutide reduces fat accumulation in the tongue: A randomized single-blind, pilot study
2021
Abstract Aim We evaluated the effect of the latest GLP-1 RA semaglutide on tongue fat storage in obese women. Design. We conducted a randomized single-blind, pilot study. Methods Twenty-five obese women with polycystic ovary syndrome (PCOS) (33.7 ± 5.3 years, body mass index (BMI) 36.1 ± 3.9 kg/m2, mean ± SD) were randomized to semaglutide 1.0 mg or placebo for 16 weeks. We quantified tongue volume and its fat tissue and fat proportion by magnetic resonance imaging. Results Tongue fat tissue and fat proportion significantly reduced after semaglutide vs placebo (-1.94 ± 5.51 vs. + 3.12 ± 4.87 cm3, p = 0.022, and −0.02 ± 0.07 vs. 0.04 ± 0.06, p = 0.010, respectively). Correlation analysis rev…
Primary endpoint results of the OMEGA Study: One-year clinical outcomes after implantation of a novel platinum chromium bare metal stent.
2014
Bare metal stents (BMS) have similar rates of death and myocardial infarction (MI) compared to drug-eluting stents (DES). DES lower repeat revascularization rates compared to BMS, but may have higher rates of late stent thrombosis (ST) potentially due to impaired endothelialization requiring longer dual anti-platelet therapy (DAPT). OMEGA evaluated a novel BMS designed to have improved deliverability and radiopacity, in comparison to currently available platforms.OMEGA was a prospective, multicenter, single-arm study enrolling 328 patients at 37 sites (US and Europe). Patients received the OMEGA stent (bare platinum chromium element stent) for the treatment of de novo native coronary artery…
Eating Competence of Elderly Spanish Adults Is Associated with a Healthy Diet and a Favorable Cardiovascular Disease Risk Profile
2010
Eating competence (EC), a bio-psychosocial model for intrapersonal approaches to eating and food-related behaviors, is associated with less weight dissatisfaction, lower BMI, and increased HDL-cholesterol in small U.S. studies, but its relationship to nutrient quality and overall cardiovascular risk have not been examined. Prevención con Dieta Mediterránea (PREDIMED) is a 5-y controlled clinical trial evaluating Mediterranean diet efficacy on the primary prevention of cardiovascular diseases (CVD) in Spain. In a cross-sectional study, 638 PREDIMED participants (62% women, mean age 67 y) well phenotyped for cardiovascular risk factors were assessed for food intake and EC using validated ques…
Managed ventricular pacing vs. conventional dual-chamber pacing for elective replacements: the PreFER MVP study: clinical background, rationale, and …
2008
Udgivelsesdato: 2008-Mar AIMS: Several clinical studies have shown that, in patients with intact atrioventricular (AV) conduction, unnecessary chronic right ventricular (RV) pacing can be detrimental. The managed ventricular pacing (MVP) algorithm is designed to give preference to spontaneous AV conduction, thus minimizing RV pacing. The clinical outcomes of MVP are being studied in several ongoing trials in patients undergoing a first device implantation, but it is unknown to what extent MVP is beneficial in patients with a history of ventricular pacing. The purpose of the Prefer for Elective Replacement MVP (PreFER MVP) study is to assess the superiority of the MVP algorithm to convention…
Salso-bromo-iodine thermal water: a nonpharmacological alternative treatment for postnasal drip-related cough in children with upper respiratory trac…
2018
Postnasal drip (PND)-related cough is a very common symptom in patients with upper respiratory tract infections (URTis). At present, there is not a standard treatment for postnasal drip and postnasal drip-related cough. The aim of this pilot study was to evaluate the efficacy of a specific salso-bromoiodine thermal water containing hyaluronic acid and grapefruit seed extract (SBI-H-GSE) comparing it with a normal saline solution in children with URTis who refer PND-related symptoms. The study was randomized, single-blind, and controlled. Study group (75 children) was treated with SBI-HGSE and control group (65 children) was treated with a normal saline solution; both compounds were administ…
Continuous measurement of cardiac output by the Fick principle in infants and children: comparison with the thermodilution method.
1996
To compare a system that continuously monitors cardiac output by the Fick principle with measurements by the thermodilution technique in pediatric patients.Prospective direct comparison of the above two techniques.Pediatric intensive care unit of a university hospital.25 infants and children, aged 1 week to 17 years (median 10 months), who had undergone open heart surgery were studied. Only patients without an endotracheal tube leak and without a residual shunt were included.The system based on the Fick principle uses measurements of oxygen consumption taken by a metabolic monitor and of arterial and mixed venous oxygen saturation taken by pulse- and fiberoptic oximetry to calculate cardiac…
Transcranial Magnetic Stimulation Combined With Nicotine Replacement Therapy for Smoking Cessation: A Randomized Controlled Trial.
2015
Abstract Background Further evidence suggests that repetitive Transcranial Magnetic Stimulation (rTMS) is an effective method to reduce tobacco craving among smokers. Hypothesis As relapse is common within a few days after smoking cessation, we hypothesized that combining the anti-craving effects of rTMS with Nicotine replacement therapy (NRT) to attenuate withdrawal symptoms could increase abstinence rates in smokers with severe nicotine dependence who quit smoking. Methods Thirty-seven smokers who failed to quit with the usual treatments were randomly assigned to two treatment groups to receive either active ( n = 18) or sham ( n = 19) 1-Hz rTMS of the right dorsolateral prefrontal cort…
Effects of a low-frequency sound wave therapy programme on functional capacity, blood circulation and bone metabolism in frail old men and women
2009
Objective: To evaluate the effects of a low-frequency sound wave therapy programme on functional capacity, blood circulation and bone metabolism of the frail elderly. Design: Single-blind, randomized, controlled trial. Setting: Two senior service centres. Subjects: Forty-nine volunteers (14 males and 35 females) aged 62—93 years with up to 12 diagnosed diseases were allocated in either the intervention group (n = 30) or control group (n = 19). Intervention: The intervention group underwent sound wave therapy, 3—5 times a week for 30 minutes per session over a period of 6 months. The control group received no intervention. Main measurements: Blood pressure, functional capacity, mobility, bo…
Effect of low-impact aerobic exercise combined with music therapy on patients with fibromyalgia. A pilot study.
2016
Abstract Objective Fibromyalgia is a pathological entity characterized by chronic widespread musculoskeletal pain and the presence of "tender points". It constitutes a significant health problem because of its prevalence and economic impact. The aim of the present study was to determine the therapeutic benefits of low impact aerobic exercise alone or in combination with music therapy in patients with fibromyalgia. Methods A single-blind randomized controlled pilot trial was performed. Thirty-five individuals with fibromyalgia were divided into three groups: (G1) therapeutic aerobic exercise with music therapy (n=13); (G2) therapeutic aerobic exercise at any rhythm (n=13) and (CG) control (n…