Search results for "Randomized controlled trial"
showing 10 items of 2199 documents
Are Asthmatics Enrolled in Randomized Trials Representative of Real-Life Outpatients?
2014
<b><i>Background/Objective:</i></b> This study was aimed at exploring to what extent populations enrolled in randomized controlled trials (RCTs) of inhalation combination treatment for mild/moderate asthma in adults are fully representative of ‘real-life' populations. The following is a retrospective analysis of the clinical records of outpatient subjects with an ascertained diagnosis of asthma. <b><i>Methods:</i></b> A retrospective analysis was performed. Stable conditions, such as smoking habit and chronic diseases other than asthma, were identified as exclusion criteria for RCTs. The selected criteria were then applied to asthmatic outpati…
Cytokeratin-18 fragments predict treatment response and overall survival in gastric cancer in a randomized controlled trial
2018
Background:Gastric cancer is common malignancy and exhibits a poor prognosis. At the time of diagnosis, the majority of patients present with metastatic disease which precludes curative treatment. Non-invasive biomarkers which discriminate early from advanced stages or predict the response to treatment are urgently required. This study explored the cytokeratin-18 fragment M30 and full-length cytokeratin-18 M65 in predicting treatment response and survival in a randomized, placebo-controlled trial of advanced gastric cancer.Methods:Patients enrolled in the SUN-CASE study received sunitinib or placebo as an adjunct to standard therapy with leucovorin (Ca-folinate), 5-fluorouracil, and irinote…
Tralokinumab did not demonstrate oral corticosteroid-sparing effects in severe asthma
2018
Long-term oral corticosteroid (OCS) use in patients with severe asthma is associated with significant adverse effects.This 40-week, randomised, double-blind trial evaluated the OCS-sparing potential of tralokinumab in patients with severe, uncontrolled asthma requiring maintenance OCS treatment plus inhaled corticosteroids/long-acting β2-agonists. Overall, 140 patients were randomised to tralokinumab 300 mg or placebo (n=70 in each group) administered subcutaneously every 2 weeks. The primary end-point was percentage change from baseline in average OCS dose at week 40, while maintaining asthma control. Secondary end-points included proportion of patients with a prescribed maintenance OCS do…
Topical azithromycin for the prevention of Lyme borreliosis: a randomised, placebo-controlled, phase 3 efficacy trial
2017
Summary Background Lyme borreliosis develops in 1–5% of individuals bitten by ticks, but with a diagnostic gap affecting up to 30% of patients, a broadly applicable pharmacological prevention strategy is needed. Topical azithromycin effectively eradicated Borrelia burgdorferi sensu lato from the skin in preclinical studies. We assessed its efficacy in human beings. Methods In this randomised, double-blind, placebo-controlled, multicentre trial done in 28 study sites in Germany and Austria, adults were equally assigned to receive topical 10% azithromycin or placebo twice daily for 3 consecutive days, within 72 h of a tick bite being confirmed. Randomisation numbers, which were stratified by …
Dietary inflammatory index and all-cause mortality in large cohorts: The SUN and PREDIMED studies
2019
[Background]: Inflammation is known to be related to the leading causes of death including cardiovascular disease, several types of cancer, obesity, type 2 diabetes, depression-suicide and other chronic diseases. In the context of whole dietary patterns, the Dietary Inflammatory Index (DII®) was developed to appraise the inflammatory potential of the diet. [Objective]: We prospectively assessed the association between DII scores and all-cause mortality in two large Spanish cohorts and valuated the consistency of findings across these two cohorts and results published based on other cohorts.
Aluminum Chloride versus Electrocauterization in Periapical Surgery: A Randomized Controlled Trial
2019
The aim of this study was to evaluate the efficacy of 2 hemostatic agents in periapical surgery and its relationship with patient- and tooth-dependent variables.A prospective study was designed with 2 randomized parallel groups established according to the hemostatic agent used: aluminum chloride or electrocauterization. The surgeon and 2 independent blinded observers examined the initial and final bleeding and recorded it as 0 (no hemorrhage control), 1 (slight but apparent intermittent bleeding), or 2 (complete hemorrhage control). The following patient- and tooth-dependent variables were collected: sex, age, smoking habit, plaque index, and position.Sixty patients with a periapical lesio…
Is telephone follow-up really effective in early diagnosis of inflammatory complications after tooth extraction?
2018
Background To establish whether telephone follow-up is really able to intercept post-extraction complications and to evaluate the degree of patient satisfaction with this kind of post-surgical monitoring. Material and Methods Six hundred and thirty-eight patients were enrolled and randomly assigned to a test or control group. Test group patients were monitored by telephone follow-up 24 and 72 hours after surgery to investigate the presence of local symptoms that are frequently associated with surgical wound infection and inflammation. Both test and control group patients were examined 7 days at suture removal. Patients with systemic diseases, those in which intra-operative accidents occurre…
Effectiveness of Mirror Therapy for Subacute Stroke in Relation to Chosen Factors.
2016
Purpose The aim of this study was to determine the effectiveness of mirror therapy (MT) combined with comprehensive treatment and to investigate the possible relationships of functional state. Design Prospective, controlled trial of 60 stroke inpatients. Methods The Functional Index "Repty" (FIR) was an outcome measure to assess changes of independence in daily activities. The Frenchay Arm Test (FAT) and Motor Status Score were outcome measures to assess changes in hand function. Findings The analysis of pre- and posttest data indicated a significant improvement in hand function ([INCREMENT]FAT in the Mirror group p = .035, N = 30). Age factor indicated a significant change in relation to F…
Effects of a vestibular physiotherapy protocol on adults with intellectual disability in the prevention of falls: A multi-centre clinical trial
2018
Background Balance alterations are one of the main problems in people with intellectual disabilities (ID), increasing their risk of falls and impacting their life. Aims To describe a vestibular rehabilitation programme (VRP) and evaluate its effects on the ability to maintain balance and risk of suffering a fall. Methods Forty-seven adults with mild to moderate ID were randomly assigned to two groups: a control group (CG, N = 24), which performed a general physical exercise only, and an experimental group (EG, N = 23) which also completed a VRP. The variables, used pre- and post-training and 1 month after the intervention, were as follows: Center of Pressure Displacement, Berg Scale, Timed …
Effects of Dual-Task Group Training on Gait, Cognitive Executive Function, and Quality of Life in People With Parkinson Disease: Results of Randomize…
2020
The aims of this study were to analyze the effects of a dual-task group program, to compare it with the effects of a single-task group program, and to analyze the effects of functional secondary tasks.Single-blind randomized controlled trial.University laboratory and a rehabilitation gym at a health center.Patients (N=40) with a diagnosis of Parkinson disease (mean age, 66.72y; age range, 44-79y) with Hoehn and Yahr stage I to III who were on medication were randomized to either a group with dual-task training or a group with single-task training (only gait).Both interventions involved 20 sessions lasting 1 hour each and conducted twice a week. Dual-task training included walking exercises …