Search results for "Randomized"
showing 10 items of 2323 documents
Promoting mobility after hip fracture (ProMo): study protocol and selected baseline results of a year-long randomized controlled trial among communit…
2011
Abstract Background To cope at their homes, community-dwelling older people surviving a hip fracture need a sufficient amount of functional ability and mobility. There is a lack of evidence on the best practices supporting recovery after hip fracture. The purpose of this article is to describe the design, intervention and demographic baseline results of a study investigating the effects of a rehabilitation program aiming to restore mobility and functional capacity among community-dwelling participants after hip fracture. Methods/Design Population-based sample of over 60-year-old community-dwelling men and women operated for hip fracture (n = 81, mean age 79 years, 78% were women) participat…
Effects of passiflora incarnata and midazolam for control of anxiety in patients undergoing dental extraction
2017
Background Anxiety symptoms are frequently observed in dental patients, whether they are undergoing simple or more invasive procedures such as surgery. This research aimed to compare the effects of Passiflora incarnata and midazolam for the control of anxiety in patients undergoing mandibular third molar extraction. Material and Methods Forty volunteers underwent bilateral extraction of their mandibular third molars in a randomized, controlled, double-blind, crossover clinical trial. Passiflora incarnata (260 mg) or midazolam (15 mg) were orally administered 30 minutes before surgery. The anxiety level of participants was evaluated by questionnaires and measurement of physical parameters, i…
Rationale and design of the Prospective LongitudinAl Trial of FFRCT: Outcome and Resource IMpacts study
2015
International audience; BACKGROUND: Fractional flow reserve (FFR) measured by coronary computed tomography angiography (FFRCT) has been validated against invasive FFR. However, there are no data on how the use of FFRCT affects patient care and outcomes. The aim of this study is to compare standard practice guided by usual care testing to FFRCT-guided management in symptomatic subjects with suspected coronary artery disease (CAD). METHODS: In this prospective nonrandomized trial, symptomatic patients with suspected CAD will be enrolled in 2 consecutive cohorts: a usual care-guided pathway (cohort 1) and an FFRCT-guided pathway (cohort 2). Each cohort is divided into 2 groups according to whe…
Use of hydroxychloroquine in hospitalised COVID-19 patients is associated with reduced mortality: Findings from the observational multicentre Italian…
2020
Abstract Background Hydroxychloroquine (HCQ) was proposed as potential treatment for COVID-19. Objective We set-up a multicenter Italian collaboration to investigate the relationship between HCQ therapy and COVID-19 in-hospital mortality. Methods In a retrospective observational study, 3,451 unselected patients hospitalized in 33 clinical centers in Italy, from February 19, 2020 to May 23, 2020, with laboratory-confirmed SARS-CoV-2 infection, were analyzed. The primary end-point in a time-to event analysis was in-hospital death, comparing patients who received HCQ with patients who did not. We used multivariable Cox proportional-hazards regression models with inverse probability for treatme…
Non‐Pharmacologic Multicomponent Interventions Preventing Delirium in Hospitalized People
2020
BACKGROUND/OBJECTIVES Delirium is a common neurobehavioral complication in hospitalized patients with a high prevalence in various clinical settings. Prevention of delirium is critical due to its common occurrence and associated poor outcomes. Our objective was to evaluate the efficacy of multicomponent interventions in preventing incident delirium in hospitalized patients at risk. DESIGN Systematic review and meta-analysis. SETTING Hospital. PARTICIPANTS We included a study if it was a randomized controlled trial and was evaluating effects of coordinated non-pharmacologic multicomponent interventions in the prevention of delirium. MEASUREMENTS We performed a systematic literature search in…
Effect of 12-Month Supervised, Home-Based Physical Exercise on Functioning Among Persons With Signs of Frailty: A Randomized Controlled Trial
2021
To investigate the effects of a 12-month home-based exercise program on functioning and falls among persons with signs of frailty.A randomized controlled trial with a 1:1 allocation.Home-based.Home-dwelling persons aged 65 years or older meeting at least 1 frailty phenotype criteria (N=300). The mean age of the participants was 82.2±6.3 years, 75% were women, 61% met 1-2 frailty criteria, and 39% met ≥3 criteria.A 12-month, individually tailored, progressive, and physiotherapist-supervised physical exercise twice a week (n=150) vs usual care (n=149).FIM, Short Physical Performance Battery (SPPB), handgrip strength, instrumental activities of daily living (IADL), and self-reported falls and …
Sense of coherence: effect on adherence and response to resistance training in older people with hip fracture history.
2013
Our aim was to study the effects of sense of coherence (SOC) on training adherence and interindividual changes in muscle strength, mobility, and balance after resistance training in older people with hip fracture history. These are secondary analyses of a 12-week randomized controlled trial of progressive resistance training in 60- to 85-year-old community-dwelling people 0.5–7 years after hip fracture (n = 45; ISRCTN34271567). Pre- and posttrial assessments included SOC, knee extension strength, walking speed, timed up-and-go (TUG), and Berg Balance Scale (BBS). Group-by-SOC interaction effects (repeated-measures ANOVA) were statistically significant for TUG (p = .005) and BBS (p = .040), …
Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial …
2015
BACKGROUND: Cardiovascular (CV) disease is the leading cause of morbidity and mortality in patients with type 2 diabetes mellitus (T2DM). Furthermore, patients with T2DM and acute coronary syndrome (ACS) have a particularly high risk of CV events. The glucagon-like peptide 1 receptor agonist, lixisenatide, improves glycemia, but its effects on CV events have not been thoroughly evaluated.METHODS: ELIXA (www.clinicaltrials.gov no. NCT01147250) is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study of lixisenatide in patients with T2DM and a recent ACS event. The primary aim is to evaluate the effects of lixisenatide on CV morbidity and mortality in a population …
Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation
2019
Background: Appropriate antithrombotic regimens for patients with atrial fibrillation who have an acute coronary syndrome or have undergone percutaneous coronary intervention (PCI) are unclear. Methods: In an international trial with a two-by-two factorial design, we randomly assigned patients with atrial fibrillation who had an acute coronary syndrome or had undergone PCI and were planning to take a P2Y12 inhibitor to receive apixaban or a vitamin K antagonist and to receive aspirin or matching placebo for 6 months. The primary outcome was major or clinically relevant nonmajor bleeding. Secondary outcomes included death or hospitalization and a composite of ischemic events. Results: Enroll…
Causes of ineligibility in randomized controlled trials and long-term mortality in patients with non-ST-segment elevation acute coronary syndromes
2006
To determine the long-term mortality of patients with non-ST-segment elevation acute coronary syndromes (NSTEACS) that are eligible versus those not eligible in randomized controlled trials (RCT), and how each exclusion criteria is associated with outcome.Common causes of exclusion in six published RCT on intravenous antithrombotic therapy were prospectively assessed in a cohort of 452 consecutive patients with NSTEACS that were followed for up to 3 years.Forty-one percent of patients had one or more exclusion criteria establishing the ineligible group. These patients were older, more likely to have coronary risk factors, ischemic ECG changes, heart failure at admission, higher creatinine l…