Search results for " method"
showing 10 items of 10455 documents
Time course of adverse events most commonly associated with topiramate for migraine prevention
2007
The efficacy, safety and tolerability of topiramate has been demonstrated in three large multicenter, randomized, double-blind, placebo-controlled trials. To characterize the time course of adverse events (AEs) that led to treatment discontinuation in/=2% of patients who received topiramate 100 mg/day during three pivotal, multicenter, randomized, double-blind, placebo-controlled, and 26-week trials. The pooled population comprised all randomized patients who reported safety data during the double-blind phase (topiramate 100 mg/day, n = 386; placebo n = 372), which consisted of a 4-week titration period and a 22-week maintenance period. Incidence, time to onset, and cumulative mean rate of …
Comparison of three methods for evaluation of work postures in a truck assembly plant
2017
International audience; This study compared the results of three risk assessment tools (self-reported questionnaire, observational tool, direct measurement method) for the upper limbs and back in a truck assembly plant at two cycle times (11 and 8 min). The weighted Kappa factor showed fair agreement between the observational and direct measurement method for the arm (0.39) and back (0.47). The weighted Kappa factor for these methods was poor for the neck (0) and wrist (0) but the observed proportional agreement (P-o) was 0.78 for the neck and 0.83 for the wrist. The weighted Kappa factor between questionnaire and direct measurement showed poor or slight agreement (0) for different body seg…
Non-invasive vagus nerve stimulation (nVNS) for the preventive treatment of episodic migraine: The multicentre, double-blind, randomised, sham-contro…
2019
Introduction Non-invasive vagus nerve stimulation (nVNS; gammaCore®) has the potential to prevent migraine days in patients with migraine on the basis of mechanistic rationale and pilot clinical data. Methods This multicentre study included a 4-week run-in period, a 12-week double-blind period of randomised treatment with nVNS or sham, and a 24-week open-label period of nVNS. Patients were to administer two 120-second stimulations bilaterally to the neck three times daily (6–8 hours apart). Results Of 477 enrolled patients, 332 comprised the intent-to-treat (ITT) population. Mean reductions in migraine days per month (primary outcome) were 2.26 for nVNS (n = 165; baseline, 7.9 days) and 1.8…
Pentaerythrityl Tetranitrate and Nitroglycerin, but not Isosorbide Mononitrate, Prevent Endothelial Dysfunction Induced by Ischemia and Reperfusion
2007
Background— Short term exposure to nitroglycerin (GTN) has protective properties that are similar to ischemic preconditioning. Whether other organic nitrates such as pentaerithrityl tetranitrate (PETN) and isosorbide mononitrate (ISMN) have similar protective effects has not been explored. Methods and Results— In a randomized, parallel, double blind, controlled trial, 37 healthy young volunteers received no therapy (n=10), transdermal GTN 1.2 mg for 2 hours (n=9), PETN 80 mg (n=9), or ISMN 40 mg (n=9). Twenty-four hours later, endothelium-dependent flow-mediated vasodilation (FMD) was measured before and after local exposure to ischemia and reperfusion (IR). In the no therapy group, IR blu…
Application of a capsaicin rinse in the treatment of burning mouth syndrome
2010
Objective: To examine the efficacy of a new topical capsaicin presentation as an oral rinse in improving the symptoms of burning mouth syndrome (BMS). Study design: A prospective, double-blind, cross-over study was made of 30 patients with BMS. There were 7 dropouts; the final study series thus comprised 23 individuals. The patients were randomized to two groups: (A) capsaicin rinse (0.02%) or (B) placebo rinse, administered during one week. After a one-week washout period, the patients were then assigned to the opposite group. Burning discomfort was scored using a visual analog scale (VAS): in the morning before starting the treatment, in the afternoon on the first day of treatment, and at…
Dose escalating safety study of CNS 5161 HCl, a new neuronal glutamate receptor antagonist (NMDA) for the treatment of neuropathic pain
2007
What is already known about this subject • Despite encouraging effects of N-methyl-D-aspartate (NMDA) receptor antagonists in reducing neuropathic pain of different aetiologies, the clinical use of these agents has been limited by their mainly psychotropic side-effects. • In a recent study in healthy volunteers, CNS 5161, a novel noncompetetive NMDA receptor antagonist, was well tolerated up to a dosage of 2000 µg without psychotropic side-effects. • This is the first study to evaluate the maximal tolerated dosage of CNS 5161 and to gain experience about the analgesic effect of CNS 5161 in patients with different pain syndromes. What this study adds • In patients with neuropathic pain CNS 5…
A phase II/III clinical study of enzyme replacement therapy with idursulfase in mucopolysaccharidosis II (Hunter syndrome)
2006
Purpose: To evaluate the safety and efficacy of recombinant human iduronate-2-sulfatase (idursulfase) in the treatment of mucopolysaccharidosis II. Methods: Ninety-six mucopolysaccharidosis II patients between 5 and 31 years of age were enrolled in a double-blind, placebo-controlled trial. Patients were randomized to placebo infusions, weekly idursulfase (0.5 mg/kg) infusions or every-other-week infusions of idursulfase (0.5 mg/kg). Efficacy was evaluated using a composite endpoint consisting of distance walked in 6 minutes and the percentage of predicted forced vital capacity based on the sum of the ranks of change from baseline. Results: Patients in the weekly and every-other-week idursul…
Effects of α-tocopherol, β-carotene and ascorbic acid on oxidative, hormonal and enzymatic exercise stress markers in habitual training activity of p…
2001
Background Intense physical exercise has been associated with an increase of free radical production. When the body's natural defense systems against free radicals are overwhelmed, oxidative stress increases. Aim of the study This study examined the effects of a vitamin antioxidant supplement, (composed of 600 mg α-tocopherol, 1000 mg ascorbic acid and 32 mg β-carotene) on oxidative, hormonal, and enzymatic exercise stress markers during habitual training activity over 35 days. Methods The plasma concentrations of ascorbic acid, α-tocopherol, β-carotene, testosterone, cortisol and lipid peroxides and the serum activities of lactate dehydrogenase and creatine kinase were measured at four tim…
Amateur Runners’ Commitment: An Analysis of Sociodemographic and Sports Habit Profiles
2020
The aim of this work is to analyse the commitment to running among urban runners by identifying groups regarding commitment to this sport and by defining their sociodemographic profile and their sports habits. A sample of 1806 participants in popular urban races in the city of Valencia was interviewed using an 11-item questionnaire on commitment to running, sociodemographic characteristics, and sports habits. The psychometric properties of the running-commitment scale allowed for the identification of two factors in commitment to running: enthusiasm for running (6 items) and affliction from running (5 items). Subsequently, a cluster analysis combining hierarchical and non-hierarchical metho…
Omalizumab rapidly improves angioedema-related quality of life in adult patients with chronic spontaneous urticaria: X-ACT study data
2018
Background The X-ACT study aims to examine the effect of omalizumab treatment on quality of life (QoL) in chronic spontaneous urticaria (CSU) patients with angioedema refractory to high doses of H1-antihistamines. Methods In X-ACT, a phase III, double-blind, placebo-controlled study, CSU patients (18–75 years) with ≥4 angioedema episodes during the 6 months before inclusion were randomized (1:1) to receive omalizumab 300 mg or placebo every 4 weeks for 28 weeks. Angioedema-related QoL, skin-related QoL impairment, and psychological well-being were assessed. Results Ninety-one patients were randomized and 68 (omalizumab, n=35; placebo, n=33) completed the 28-week treatment period. At baselin…