Search results for "randomized controlled trial"

Immediate effects of the respiratory stimulation on ventilation parameters in ischemic stroke survivors: A randomized interventional study (CONSORT).

2019

Background: Post-stroke brain damage, which affects the central control of respiration, leads to various respiratory disorders. They can be caused by the weakening of the respiratory muscles and chest movements, which can indirectly contribute to an impairment of the ventilation function. The aim of the study is an objective assessment of the effect of a single-session intervention of respiratory stimulation through Proprioceptive Neuromuscular Facilitation (PNF) on chosen respiratory parameters and the following comparison of these changes with a group in which positioning was used (intra- and intergroup comparison). Methods: This was a randomized interventional study evaluating the respir…

Effect of a common exercise programme with an individualised progression criterion based on the measurement of neuromuscular capacity versus current …

2021

IntroductionHigh-load resistance training has shown positive effects in pain and function in lower limb tendinopathies. However, some authors suggest that current exercise programmes produce an increase in tolerance to load and exercise in general but without fixing some existing issues in tendinopathy. This may indicate the need to include training aspects not currently taken into account in the current programmes. The main objective of this study will be to compare the effect of a common exercise protocol for the three predominant lower limb tendinopathies (Achilles, patellar and gluteal), based on an individualised control of the dose and training of specific aspects of the neuromuscular…

Statin therapy in patients with aortic stenosis after the ASTRONOMER trial: is there still any space?

2011

Power of the Wilcoxon–Mann–Whitney test for non‐inferiority in the presence of death‐censored observations

2017

In clinical trials with patients in a critical state, death may preclude measurement of a quantitative endpoint of interest, and even early measurements, for example for intention-to-treat analysis, may not be available. For example, a non-negligible proportion of patients with acute pulmonary embolism will die before 30 day measurements on the efficacy of thrombolysis can be obtained. As excluding such patients may introduce bias, alternative analyses, and corresponding means for sample size calculation are needed. We specifically consider power analysis in a randomized clinical trial setting in which the goal is to demonstrate noninferiority of a new treatment as compared to a reference t…

Assessing covariate imbalance in meta-analysis studies.

2010

The main goal of meta-analysis is to combine data across studies or data sets to obtain summary estimates. In this paper, the novelty is to propose a statistical tool to assess a possible covariate imbalance in baseline variables to investigate similarity of trials. We conducted the detection of the covariate imbalance, first, through some graphical comparison of the empirical cumulative distribution functions or ECDFs, which are built by putting together arms or trials according to some risk factor, and second, through some non-parametric tests such as the Kolmogorov–Smirnov and the Anderson–Darling tests. To overcome the huge presence of ties, we conducted the statistical tests on perturbe…

Test and power considerations for multiple endpoint analyses using sequentially rejective graphical procedures

2009

A variety of powerful test procedures are available for the analysis of clinical trials addressing multiple objectives, such as comparing several treatments with a control, assessing the benefit of a new drug for more than one endpoint, etc. However, some of these procedures have reached a level of complexity that makes it difficult to communicate the underlying test strategies to clinical teams. Graphical approaches have been proposed instead that facilitate the derivation and communication of Bonferroni-based closed test procedures. In this paper we give a coherent description of the methodology and illustrate it with a real clinical trial example. We further discuss suitable power measur…

Sample size in cluster-randomized trials with time to event as the primary endpoint

2011

In cluster-randomized trials, groups of individuals (clusters) are randomized to the treatments or interventions to be compared. In many of those trials, the primary objective is to compare the time for an event to occur between randomized groups, and the shared frailty model well fits clustered time-to-event data. Members of the same cluster tend to be more similar than members of different clusters, causing correlations. As correlations affect the power of a trial to detect intervention effects, the clustered design has to be considered in planning the sample size. In this publication, we derive a sample size formula for clustered time-to-event data with constant marginal baseline hazards…

Short implants (8mm) versus longer implants (≥8mm) with lateral sinus floor augmentation in posterior atrophic maxilla: A meta-analysis of RCT`s in h…

2019

Background One of the greatest challenges that dentists face today is to rehabilitate severe atrophied alveolar ridges in partially and completely edentulous patients with implants. Despite the high survival rate of implants placed next to sinus elevation, this technique presents complications that can be avoided by placing short implants, an option that also presents high survival rates. For this reason, the aim of this study is to compare the survival rate, marginal bone loss and complications associated with short implants (<8 mm) versus longer implants (≥8mm) placed with lateral sinus floor elevation in posterior atrophic maxillae. Material and Methods A literature search was conducted …

Stroke subtypes and their possible implication in stroke prevention drug strategies

2014

Thrombotic strokes can affect large or small arteries in the brain. Drugs to prevent atherosclerosis complication such as thrombotic strokes, should be drugs able to prevent the accumulation of intravascular fat, reduce vascular proliferation, decrease blood pressure levels with the resulting shear stress, reduce platelet aggregation, and possibly partially or totally reverse carotid plaques. Any of the commonly used antihypertensive drugs lower the incidence of stroke, with larger reductions in BP resulting in larger reductions in risk. Experimental and clinical data suggest that reducing the activity of the renin-angiotensin aldosterone system (RAAS) may have beneficial effects beyond the…

Everolimus eluting bioresorbable vascular scaffolds in patients with acute coronary syndromes: Two‐year results from the German‐Austrian ABSORB regis…

2021

Abstract Objectives To identify potential differences in 2‐year outcome between patients who underwent coronary revascularization using bioresorbable vascular scafffolds (BVS) in stable coronary artery disease (CAD) and acute coronary syndromes (ACS). Background Data from randomized trials suggest a significantly higher event rate following coronary revascularization using everolimus‐eluting BVS as compared to new generation drug eluting stents. Whether particular patient subgroups are at increased risk for scaffold thrombosis and target lesion failure (TLF) has not clearly been demonstrated. Methods German‐Austrian ABSORB RegIstRy is a prospective all‐comer multi‐center observational study…