Search results for "Randomized Controlled Trial"
showing 10 items of 2199 documents
Hydrolyzed infant formula and early β-cell autoimmunity: a randomized clinical trial.
2014
Importance The disease process leading to clinical type 1 diabetes often starts during the first years of life. Early exposure to complex dietary proteins may increase the risk of β-cell autoimmunity in children at genetic risk for type 1 diabetes. Extensively hydrolyzed formulas do not contain intact proteins. Objective To test the hypothesis that weaning to an extensively hydrolyzed formula decreases the cumulative incidence of diabetes-associated autoantibodies in young children. Design, Setting, and Participants A double-blind randomized clinical trial of 2159 infants with HLA-conferred disease susceptibility and a first-degree relative with type 1 diabetes recruited from May 2002 to Ja…
Acetylcholinesterase inhibitors and memantine in bipolar disorder: A systematic review and best evidence synthesis of the efficacy and safety for mul…
2016
Abstract Background Acetylcholinesterase inhibitors (AceI) and memantine might prove useful in bipolar disorder (BD) given their neuroprotective and pro-cognitive effects, as highlighted by several case reports. We aimed to systematically review the efficacy and safety of AceI and memantine across multiple outcome dimensions in BD. Methods Systematic PubMed and SCOPUS search until 04/17/2015 without language restrictions. Included were randomized controlled trials (RCTs), open label studies and case series of AceI or memantine in BD patients reporting quantitative data on depression, mania, psychotic symptoms, global functioning, or cognitive performance. We summarized results using a best-…
Lysine pathway metabolites and the risk of type 2 diabetes and cardiovascular disease in the PREDIMED study: results from two case-cohort studies
2019
[Background]: The pandemic of cardiovascular disease (CVD) and type 2 diabetes (T2D) requires the identification of new predictor biomarkers. Biomarkers potentially modifiable with lifestyle changes deserve a special interest. Our aims were to analyze: (a) The associations of lysine, 2-aminoadipic acid (2-AAA) or pipecolic acid with the risk of T2D or CVD in the PREDIMED trial; (b) the effect of the dietary intervention on 1-year changes in these metabolites, and (c) whether the Mediterranean diet (MedDiet) interventions can modify the effects of these metabolites on CVD or T2D risk. [Methods]: Two unstratified case-cohort studies nested within the PREDIMED trial were used. For CVD analyses…
Do adverse events after manual therapy for back and/or neck pain have an impact on the chance to recover? A cohort study.
2019
Background: Manual therapy is a commonly used treatment for patients with back and neck pain. Studies have shown that manual therapy-related adverse events are mainly short in duration and mild or moderate by their intensity, affecting up to 50% of the patients. If the presence of adverse events has an impact on the chance to recover from back/neck pain is poorly understood. The aim of this study was to investigate if mild or moderate adverse events after manual therapy has an impact on the chance to recover from back/neck pain in men and women. Methods: A prospective cohort study of 771 patients with at least three treatment sessions in a randomized controlled trial performed in January 20…
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 …