Randomized controlled trial

About: Randomized controlled trial is a research topic. Over the lifetime, 119828 publications have been published within this topic receiving 4861808 citations. The topic is also known as: RCT & randomized control trial.

Dexamethasone in Hospitalized Patients with Covid-19

Abstract: BackgroundCoronavirus disease 2019 (Covid-19) is associated with diffuse lung damage. Glucocorticoids may modulate inflammation-mediated lung injury and thereby reduce progression to respiratory failure and death.MethodsIn this controlled, open-label trial comparing a range of possible treatments in patients who were hospitalized with Covid-19, we randomly assigned patients to receive oral or intravenous dexamethasone (at a dose of 6 mg once daily) for up to 10 days or to receive usual care alone. The primary outcome was 28-day mortality. Here, we report the final results of this assessment.ResultsA total of 2104 patients were assigned to receive dexamethasone and 4321 to receive usual care. Overall, 482 patients (22.9%) in the dexamethasone group and 1110 patients (25.7%) in the usual care group died within 28 days after randomization (age-adjusted rate ratio, 0.83; 95% confidence interval [CI], 0.75 to 0.93; P<0.001). The proportional and absolute between-group differences in mortality varied considerably according to the level of respiratory support that the patients were receiving at the time of randomization. In the dexamethasone group, the incidence of death was lower than that in the usual care group among patients receiving invasive mechanical ventilation (29.3% vs. 41.4%; rate ratio, 0.64; 95% CI, 0.51 to 0.81) and among those receiving oxygen without invasive mechanical ventilation (23.3% vs. 26.2%; rate ratio, 0.82; 95% CI, 0.72 to 0.94) but not among those who were receiving no respiratory support at randomization (17.8% vs. 14.0%; rate ratio, 1.19; 95% CI, 0.92 to 1.55).ConclusionsIn patients hospitalized with Covid-19, the use of dexamethasone resulted in lower 28-day mortality among those who were receiving either invasive mechanical ventilation or oxygen alone at randomization but not among those receiving no respiratory support. (Funded by the Medical Research Council and National Institute for Health Research and others; RECOVERY ClinicalTrials.gov number, NCT04381936. opens in new tab; ISRCTN number, 50189673. opens in new tab.)

Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes

Abstract: BackgroundThe cardiovascular effect of liraglutide, a glucagon-like peptide 1 analogue, when added to standard care in patients with type 2 diabetes, remains unknown. MethodsIn this double-blind trial, we randomly assigned patients with type 2 diabetes and high cardiovascular risk to receive liraglutide or placebo. The primary composite outcome in the time-to-event analysis was the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The primary hypothesis was that liraglutide would be noninferior to placebo with regard to the primary outcome, with a margin of 1.30 for the upper boundary of the 95% confidence interval of the hazard ratio. No adjustments for multiplicity were performed for the prespecified exploratory outcomes. ResultsA total of 9340 patients underwent randomization. The median follow-up was 3.8 years. The primary outcome occurred in significantly fewer patients in the liraglutide group (608 of 4668 patients [13.0%]) than in the placebo ...

What is a randomised controlled trial

Abstract: Method Fifty-seven parents randomised to I0 weeks ofex~erimental Habilitation programmes for intellectual disability are primitive in developing countries (Heron & Myers, 1983). Resources to develop specialist care are scarce in these nations. One compensatory option for this deficit is to facilitate the primary care-giver to take on the role of therapist (McLoughlin, 1992), because parents are the focus of intervention (Myreddi, 1992). Parental attitude influences the development and training of the developmentally disabled child (Beckett-Edwards, 1994) and is a dynamic adaptational process subject to change (Gallimore et al, 1993). Changes in and control therapy were assessed using parental attitude occur with intervention the Parental Attitude Scale towards the (Bruiner & Beck, 1984; Sameroff & Managementof Intellectual DisabilityThe 1990). Interventions with parents are varpreand post-intervention measurements ied (Girimaii, 19931, including a model were done by a single-blinded rater and with an O ~ ~ O r m n i t y raise questions and discuss problems over a period of time (Stecompared. phens & Wyatt, 1969; Cunningham et al, Results The intervention group had a 1993). This randomised-controlled ma1 evalustatistically significant increase in the ates the efficacy of Interactive Group outcome scores and clinical improvement psychoeducation (IGP) in changing attiin the total parental attitude score, tudes towards children with intellectual orientation towards child-rearing, disability.

A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19.

Abstract: Background No therapeutics have yet been proven effective for the treatment of severe illness caused by SARS-CoV-2. Methods We conducted a randomized, controlled, open-label trial involvin...

The Effect of Riding as an Alternative Treatment for Children with Cerebral Palsy: A Systematic Review and Meta-Analysis

Abstract: Background and Objectives: There is a substantial body of evidence assessing the effects of equine-assisted therapy on physiological and psychological aspects of individuals with disabilities. This study aimed to evaluate the physiological benefits of this alternative therapy for children with cerebral palsy (CP) by means of a systematic review and meta-analysis. Methods: This systematic review included all randomized and nonrandomized clinical trials of hippotherapy (HT), therapeutic horse riding (THR), and artificial saddle (AS) for the treatment of children with CP by a systematic search in Medline, Embase, Cochrane Library, and other databases up to November 2012. Articles were assessed for inclusion eligibility and quality by two independent reviewers. Any discordant case was re-reviewed and consensus was obtained after sufficient discussion. A random effects model of meta-analysis was applied to provide summary statistics for each outcome. Results: Seven randomized controlled trials (RCTs), 4 non-RCTs, and 7 self-controlled studies were included for quality assessment. Ten studies assessed the effect of HT, 5 evaluated THR, and 3 evaluated AS. The sample size differed from 3 to 72, and the quality ranged from low to moderate. Six studies were included in the meta-analysis, and there was a significant improvement in the 66-item Gross Motor Function Measure (GMFM-66), the GMFM-66/88 total score, and the dimension E of the GMFM. Although the asymmetry score tended to be reduced, it failed to reach statistical significance. Conclusions: HT, THR, and AS seem to improve the total score of the gross motor function via improvement of the walking, running, and jumping dimension. However, they are not likely to be of benefit to the symmetry of postural muscle activity. Studies included in this review lack high-quality RCTs with a sufficient number of subjects, which thus warrants further evaluations of these modalities using large-scale well-designed RCTs.