Search results for " Method."
showing 10 items of 10241 documents
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…
Tauroursodeoxycholic acid in the treatment of patients with amyotrophic lateral sclerosis
2015
Background and purpose: Tauroursodeoxycholic acid (TUDCA) is a hydrophilic bile acid that is produced in the liver and used for treatment of chronic cholestatic liver diseases. Experimental studies suggest that TUDCA may have cytoprotective and anti-apoptotic action, with potential neuroprotective activity. A proof of principle approach was adopted to provide preliminary data regarding the efficacy and tolerability of TUDCA in a series of patients with amyotrophic lateral sclerosis (ALS). Methods: As a proof of principle, using a double-blind placebo controlled design, 34 ALS patients under treatment with riluzole who were randomized to placebo or TUDCA (1 g twice daily for 54 weeks) were e…
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 …
Application of tRNS to improve multiple sclerosis fatigue: a pilot, single-blind, sham-controlled study
2019
We evaluated the effects of transcranial random noise stimulation (tRNS) on fatigue in 17 subjects with relapsing–remitting multiple sclerosis with low physical disability. Two different patient groups underwent real or sham stimulation for 10 days, targeting the primary motor cortex of the dominant side or contralateral to the most compromised limb. In the ‘real group’, beneficial effects were observed using the Modified Fatigue Impact Scale (p = 0.04; physical subscale: p = 0.03), the subscales ‘change in health’ (p = 0.006) and ‘role limitations due to physical problems’ (p = 0.001) of the Multiple Sclerosis Quality of Life-54, and by assessing the patient impression of perceived fatigue…
Impact of hypertonic saline nebulisation combined with oscillatory positive expiratory pressure on sputum expectoration and related symptoms in cysti…
2018
Abstract Objective To evaluate the impact of combining nebulised hyaluronic acid plus hypertonic saline (HA + HS) with oscillatory positive expiratory pressure (oscillatory-PEP) on sputum expectoration and related symptoms in adults with cystic fibrosis (CF). Design Randomised crossover trial. Setting Seven centres. Participants Twenty-two outpatients with CF. Interventions Usual care (HA + HS followed by autogenic drainage) and combined therapy (HA + HS with oscillatory-PEP followed by autogenic drainage]. Each treatment was performed for 5 days. Main outcome measures Sputum expectoration was measured during the nebulisation period (primary outcome), during autogenic drainage and for 24 ho…
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 …
The Social Phobia and Anxiety Inventory: Psychometric Properties in a Spanish Sample
2007
This study is a validation of the Spanish version of the Social Phobia and Anxiety Inventory using a nonclinical sample (198 participants) and a clinical sample (72 participants with social phobia). The factor structure and concurrent validity with Fear of Negative Evaluation and Social Avoidance and Distress scales were analyzed. The Social Phobia and Anxiety Inventory demonstrated good concurrent validity, showing statistically significant relationships with Fear of Negative Evaluation and Social Avoidance and Distress. Results confirmed the rationale for the division of the SPAI into two subscales. Results also demonstrated the utility of the Social Phobia and Anxiety Inventory for diff…
From being alone to being the only one: Neuroticism is associated with an egocentric shift in an alone context
2019
Objective This research presents evidence for an egocentric shift occurring among individuals high in Neuroticism by the mere thought-and actual state-of being alone. Method Four experiments and one experience sampling study (N = 719). In the experiments, Neuroticism was measured, and participants were randomly primed to adopt either an alone or a "with others" social context mind-set. The experiments measured different expressions of egocentrism. Study 1 measured perspective-taking, Study 2a was focused on social value orientation, Study 2b measured money allocation in a dictator game, and Study 3 measured self-reported and behavioral interpersonal trust. Trust was also the focus of Study …
An adaptive virtual reality system for the treatment of adjustment disorder and complicated grief: 1-year follow-up efficacy data.
2019
This is the pre-peer reviewed version of the following article: An adaptive virtual reality system for the treatment of adjustment disorder and complicated grief: 1‐year follow‐up efficacy data, which has been published in final form at https://doi.org/10.1002/cpp.2342. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Use of Self-Archived Versions. Adjustment disorder (AD) and complicated grief (CG) are serious mental conditions that have a high prevalence and are associated with significant impairments in social and work functioning. Recently, these categories have been better specified in the new ICD‐11 proposal. Empirical research on …