Search results for "Randomized controlled"
showing 10 items of 2220 documents
Effects of long-acting bronchodilators in COPD patients according to COPD severity and ICS use
2013
SummaryBackgroundIndacaterol is a once-daily, long-acting β2-agonist bronchodilator that improves dyspnoea and health status in patients with moderate-to-severe COPD. While its bronchodilator effects have been shown to be maintained in different patient subgroups, effects on clinical outcomes in certain subgroups are not yet defined.MethodsPost-hoc analysis of pooled clinical study data to investigate efficacy and safety of indacaterol compared with placebo and other long-acting bronchodilators (formoterol, salmeterol, open-label tiotropium) in patient subgroups defined by COPD severity (GOLD stage II or III; n = 4082) and ICS use at baseline (no/yes; n = 4088). Efficacy outcomes were troug…
Effects of a Classroom Training Program for Promoting Health Literacy Among IT Managers in the Workplace: A Randomized Controlled Trial.
2018
Objective IT managers have received limited attention in health literacy research, although they are subject to special professional demands. The aim of this study was to evaluate a training program designed to promote health literacy among managers. Methods A randomized controlled trial with a sample of 171 industry managers from one IT company was conducted. Effects of classroom training on health literacy, psychological well-being, self-rated health, and cortisol awakening response were investigated using pre- (t0), post- (t1), and follow-up (t2) surveys. Results The intervention effects (time and group) were not significant for the primary outcome of health literacy. At the second measu…
Health-related quality of life in individuals with metabolic syndrome: A cross-sectional study
2020
Abstract Introduction and objectives Metabolic syndrome (MetS) is a combination of various cardiovascular risk factors with a major impact on morbidity and premature mortality. However, the impact of MetS on self-reported health-related quality of life (HRQoL) is unknown. This study evaluated the HRQoL in a Spanish adult population aged 55 years and older with MetS. Method A cross-sectional analysis was performed with baseline data from the PREDIMED-Plus multicentre randomized trial. The participants were 6430 men and women aged 55–75 years with overweight/obesity (body mass index ≥27 and ≤40 kg/m2) and MetS. The SF-36 questionnaire was used as a tool to measure HRQoL. Scores were calculate…
Effects on the incidence of cardiovascular events of the addition of pioglitazone versus sulfonylureas in patients with type 2 diabetes inadequately …
2017
Background The best treatment option for patients with type 2 diabetes in whom treatment with metformin alone fails to achieve adequate glycaemic control is debated. We aimed to compare the long-term effects of pioglitazone versus sulfonylureas, given in addition to metformin, on cardiovascular events in patients with type 2 diabetes. Methods TOSCA.IT was a multicentre, randomised, pragmatic clinical trial, in which patients aged 50â75 years with type 2 diabetes inadequately controlled with metformin monotherapy (2â3 g per day) were recruited from 57 diabetes clinics in Italy. Patients were randomly assigned (1:1), by permuted blocks randomisation (block size 10), stratified by site and…
Evaluation of the clinical and histological effectiveness of isoretinoin in the therapy of oral leukoplakia. Ten years of experience: is management s…
2006
Various studies have evaluated the therapeutic effectiveness of vitamin A derivatives in the treatment of oral leukoplakia (OL). Not all the studies have shown concordant results. The aim of our study, which has a 10-year follow-up, was to test the effectiveness of topical therapy based on 0.18% isotretinoin by comparing it with that most frequently used, i.e., at 0.05% concentration. Forty patients with an established diagnosis of OL were involved in the study. The patients were randomly divided into two groups and the drug was administered topically at 0.05% and 0.18% concentrations. The drug was applied twice a day for 3 consecutive months; then it was suspended for 1 month, and the biop…
Increased CSF APPs- levels in patients with Alzheimer disease treated with acitretin
2014
Objective: We investigated induction of α-secretase A disintegrin and metalloprotease 10 (ADAM10) by the synthetic retinoid acitretin (Neotigason; Actavis, Munchen-Riem, Germany) in patients with mild to moderate Alzheimer disease (AD) via measurement of CSF content of α-secretase–derived amyloid precursor protein (APPs-α). Methods: Twenty-one patients clinically diagnosed with mild to moderate AD received acitretin (30 mg per day) or placebo in a 4-week double-blind study. Primary endpoint was the difference of CSF APPs-α ratios calculated from the APPs-α levels after treatment and at baseline. We monitored safety and tolerability of the treatment. In addition, we assessed biomarkers such …
Effect of active compression–decompression resuscitation (ACD-CPR) on survival: a combined analysis using individual patient data
1999
Active compression decompression resuscitation (ACD-CPR) has been developed as an alternative to standard cardiopulmonary resuscitation (S-CPR). To determine the effect of ACD-CPR on survival and neurologic outcome in patients with out-of-hospital cardiac arrest, this combined analysis involved individual patient data from 2866 patients from seven separate randomized prospective prehospital studies who had received ACD-CPR or S-CPR after out-of-hospital cardiac arrest in seven international sites. Significant improvement in 1-h survival (odds ratio (OR) = 0.83; confidence interval (CI): 0.695-0.99; P0.05) was found with ACD-CPR (n = 1410) versus S-CPR (n = 1456). The odds ratio for hospital…
The Full Revasc (Ffr-gUidance for compLete non-cuLprit REVASCularization) Registry-based randomized clinical trial
2021
Publisher Copyright: © 2021 Background: Complete revascularization in ST elevation myocardial infarction (STEMI) patients with multivessel disease has resulted in reduction in composite clinical endpoints in medium sized trials. Only one trial showed an effect on hard clinical endpoints, but the revascularization procedure was guided by angiographic evaluation of stenosis severity. Consequently, it is not clear how Fractional Flow Reserve (FFR)-guided percutaneous coronary intervention (PCI) affects hard clinical endpoints in STEMI. Methods and Results: The Ffr-gUidance for compLete non-cuLprit REVASCularization (FULL REVASC) – is a pragmatic, multicenter, international, registry-based rand…
Effects of total dietary polyphenols on plasma nitric oxide and blood pressure in a high cardiovascular risk cohort. The PREDIMED randomized trial
2014
© 2014 Elsevier B.V. Background and aim: Hypertension is one of the main cardiovascular risk factors in the elderly. The aims of this work were to evaluate if a one-year intervention with two Mediterranean diets (Med-diet) could decrease blood pressure (BP) due to a high polyphenol consumption, and if the decrease in BP was mediated by plasma nitric oxide (NO) production. Methods and results: An intervention substudy of 200 participants at high cardiovascular risk was carried out within the PREDIMED trial. They were randomly assigned to a low-fat control diet or to two Med-diets, one supplemented with extra virgin olive oil (Med-EVOO) and the other with nuts (Med-nuts). Anthropometrics and …
Influence of Hemostatic Agents in the Prognosis of Periapical Surgery: A Randomized Study of Epinephrine versus Aluminum Chloride
2017
Abstract Introduction Several variables have been associated with a better prognosis of periapical surgery. The aim of this study was to evaluate the influence of 2 hemostatic agents on the prognosis of periapical surgery at 12 months. Methods A prospective study was designed with 2 randomized parallel groups established depending on the hemostatic agent used: epinephrine or aluminum chloride. The analysis of the hemorrhage control was recorded as 0 (no hemorrhage control), 1 (slight but apparent intermittent bleeding persisted after application of the material), or 2 (complete hemorrhage control). At 12 months, periapical lesion healing was determined clinically and radiologically as succe…