Search results for "SCHEDULE"
showing 10 items of 567 documents
Efficacy, safety and quality of life of calcipotriol/betamethasone dipropionate (Dovobet (R)) versus calcipotriol (Daivonex (R)) in the treatment of …
2007
Objective: A clinical trial was performed to evaluate the efficacy, speed of response, side effects and quality of life of patients treated with calcipotriol/betamethasone dipropionate (Dovobet (R)) for 4 weeks followed by maintenance with calcipotriol for 8 weeks (group A) versus calcipotriol (Daivonex (R)) alone for 12 weeks (group B) for the treatment of psoriasis. Materials and methods: A total of 150 patients were enrolled and randomized to groups A and B. PASI and Skindex-29 were considered the outcome measures. Results: Ninety-six patients completed the trial. At weeks 2 and 4, both groups showed a significant clinical improvement compared to baseline; group A demonstrated a higher c…
OASIS-HT: design of a pharmacogenomic dose-finding study.
2005
Experimental evidence and observations in humans strongly support an interactive role of mutated α-adducin, sodium (Na+)/potassium (K+)-adenosine triphosphatase (ATPase) activity and endogenous ouabain in Na+homeostasis and the pathogenesis of hypertension. The Ouabain and Adducin for Specific Intervention on Sodium in HyperTension (OASIS-HT) trial is an early Phase II dose-finding study, which will be conducted across 39 European centers. Following a run-in period of 4 weeks without treatment, eligible patients will be randomized to one of five oral doses of rostafuroxin consisting of 0.05, 0.15, 0.5, 1.5, or 5.0 mg/day. Each dose will be compared to a placebo in a double-blind crossover e…
Different doses of consensus interferon plus ribavirin in patients with hepatitis C virus genotype 1 relapsed after interferon monotherapy: a randomi…
2006
AIM: To assess the efficacy of different schedules of consensus interferon (CIFN) plus ribavirin in retreating chronic hepatitis C patients who relapsed after recombinant interferon (rIFN) monotherapy. METHODS: Forty-five patients (34 males and 11 females) with chronic hepatitis due to hepatitis C virus (HCV) genotype 1 who relapsed after a previous course of rIFN monotherapy were randomized to receive 9 μg CIFN three times per week for 52 wk (group A, n = 22) or 18 μg CIFN three times per week for 52 wk (group B, n = 23) in combination with ribavirin 800 to 1200 mg daily for 52 wk (according to body weight). Virological response was evaluated at week 24 (EVR), at the end of treatment (ETR)…
Beclomethasone dipropionate in Crohn's ileitis: A randomised, double-blind trial.
2011
Abstract Background Steroids, the mainstay of Crohn's disease treatment, have been associated with systemic side effects. Aim To evaluate the efficacy and tolerability of beclomethasone dipropionate for maintaining remission induced by a short course of systemic steroids in patients with Crohn's ileitis with or without right colonic involvement. Methods Patients (n = 84) with active Crohn's disease who achieved remission during a 2-week prednisone run-in period were randomised to receive beclomethasone dipropionate for 24 weeks or continue prednisone for a further 2 weeks followed by placebo for 22 weeks. The primary outcome was relapse rate (Crohn's Disease Activity Index score > 150 and a…
Gender aspects in the clinical treatment of schizophrenic inpatients with amisulpride: a therapeutic drug monitoring study.
2006
INTRODUCTION: It is assumed that female and male schizophrenic patients respond differentially to acute and chronic treatment with antipsychotics because of pharmacokinetic and pharmacodynamic factors linked to hormonal and constitutional gender differences. However, to date no empirical evidence exists in support of this notion. METHODS: In a naturalistic clinical study, we investigated gender differences in a sample of schizophrenic inpatients with acute exacerbation treated with the atypical antipsychotic amisulpride, a selective dopamine D2/D3 receptor antagonist with proven antipsychotic efficacy. Prescribed amisulpride dose, plasma level, clinical response (CGI), and side effects (UKU…
Sleepiness, sleep, and use of sleepiness countermeasures in shift-working long-haul truck drivers
2015
Driver sleepiness is a prevalent phenomenon among professional drivers working unconventional and irregular hours. For compromising occupational and traffic safety, sleepiness has become one of the major conundrums of road transportation. To further elucidate the phenomenon, an on-road study canvassing the under-explored relationship between working hours and sleepiness, sleep, and use of sleepiness countermeasures during and outside statutory rest breaks was conducted. Testing the association between the outcomes and working hours, generalized estimating equations models were fitted on a data collected from 54 long-haul truck drivers (mean 38.1 ± 10.5 years, one female) volunteering in the…
GnRH agonist administration at the time of implantation does not improve pregnancy outcome in intrauterine insemination cycles: a randomized controll…
2009
Objective To assess whether GnRH agonist administration in the luteal phase improves pregnancy outcome in intrauterine insemination (IUI) cycles. Design Single-center, randomized, single-blind, placebo-controlled trial. Setting University-affiliated infertility clinic, between February 2005 and December 2007. Patient(s) Three hundred forty-four women undergoing IUI owing to mild to moderate male factor or donor sperm indication. Intervention(s) Random administration to either a single subcutaneous injection of 0.1 mg triptorelin (group A; n = 172) 8 days after hCG administration, or solvent only (group B; n=172) at the same time. Main Outcome Measure(s) Pregnancy rate was the primary outcom…
Long-term use of deferiprone significantly enhances left-ventricular ejection function in thalassemia major patients
2012
A multicenter randomized open-label long-term sequential deferiprone–deferoxamine (DFP-DFO) versus DFP alone trial (sequential DFP-DFO) performed in patients with thalassemia major (TM) was retrospectively reanalyzed to assess the variation in the left ventricular ejection fraction (LVEF) [1].
Long-Term Effects of the Substituted Benzamide Derivative Amisulpride on Baseline and Stimulated Prolactin Levels
2002
In the present study, we investigated the long-term effects of treatment with amisulpride, a substituted benzamide derivative, as compared with the effects of treatment with flupenthixol, a thioxanthene, on the prolactin levels in schizophrenic patients. After completing 6 weeks of medication with either amisulpride or flupenthixol, the patients entered a long-term maintenance treatment with amisulpride 200–600 mg/day or flupenthixol 5–15 mg/day for a maximum of 12 months with a subsequent drug-free follow-up until month 15. Eighteen initially included patients were still participating in the study at month 6. In the flupenthixol group, only 1 patient treated reached month 12, and none of t…
Iloprost treatment in patients with Raynaud's phenomenon secondary to systemic sclerosis and the quality of life: a new therapeutic protocol
2006
Objectives: to evaluate the clinical efficacy and the effects on the quality of life of Iloprost, a prostacyclin analogue, used, according to a new protocol, in patients with Raynaud’s phenomenon secondary to Systemic Sclerosis. Methods: in this randomized study we treated 30 patients with Iloprost given by intravenous infusion, at progressively increasing doses (starting from 0.5 ng/Kg/min up 2 ng/Kg/min) over a period of 6 hours a day for ten days in two consecutive weeks, with repeated cycles at regular intervals of three months for 18 months. The results were compared with those obtained in 30 other patients, who had received the same drug but with different posologic schemes. Results: …