Search results for "Randomized"
showing 10 items of 2323 documents
The impact of aircraft noise on vascular and cardiac function in relation to noise event number: a randomized trial
2020
Abstract Aims Nighttime aircraft noise exposure has been associated with increased risk of hypertension and myocardial infarction, mechanistically linked to sleep disturbance, stress, and endothelial dysfunction. It is unclear, whether the most widely used metric to determine noise exposure, equivalent continuous sound level (Leq), is an adequate indicator of the cardiovascular impact induced by different noise patterns. Methods and results In a randomized crossover study, we exposed 70 individuals with established cardiovascular disease or increased cardiovascular risk to two aircraft noise scenarios and one control scenario. Polygraphic recordings, echocardiography, and flow-mediated dila…
Patterns of objectively measured sedentary time in 10- to 12-year-old Belgian children: an observational study within the ENERGY-project
2017
Background This study examined the frequency of and differences in sedentary bouts of different durations and the total time spent in sedentary bouts on a weekday, a weekend day, during school hours, during after-school hours and in the evening period in a sample of 10- to 12-year-old Belgian children. Methods Accelerometer data were collected as part of the ENERGY-project in Belgium (n = 577, 10.9 ± 0.7 years, 53% girls) in 2011. Differences in total sedentary time, sedentary bouts of 2–5, 5–10, 10–20, 20–30 and ≥30 min and total time accumulated in those bouts were examined on a weekday, a weekend day, during school hours, during after-school hours and in the evening period, using multile…
Factor structure and measurement invariance across various demographic groups and over time for the phq-9 in primary care patients in spain
2018
The Patient Health Questionnaire (PHQ-9) is a widely-used screening tool for depression in primary care settings. The purpose of the present study is to identify the factor structure of the PHQ-9 and to examine the measurement invariance of this instrument across different sociodemographic groups and over time in a sample of primary care patients in Spain. Data came from 836 primary care patients enrolled in a randomized controlled trial (PsicAP study) and a subsample of 218 patients who participated in a follow-up assessment at 3 months. Confirmatory factor analysis (CFA) was used to test one- and two-factor structures identified in previous studies. Analyses of multiple-group invariance w…
Time-restricted eating effects on performance, immune function, and body composition in elite cyclists: a randomized controlled trial.
2020
Abstract Background Although there is substantial interest in intermittent fasting as a dietary approach in active individuals, information regarding its effects in elite endurance athletes is currently unavailable. The present parallel randomized trial investigated the effects of a particular intermittent fasting approach, called time-restricted eating (TRE), during 4 weeks of high-level endurance training. Methods Sixteen elite under-23 cyclists were randomly assigned either to a TRE group or a control group (ND). The TRE group consumed 100% of its estimated daily energy needs in an 8-h time window (from 10:00 a.m. to 6:00 p.m.) whilst energy intake in the ND group was distributed in 3 me…
Longterm Retention of Tumor Necrosis Factor-α Inhibitor Therapy in a Large Italian Cohort of Patients with Rheumatoid Arthritis from the GISEA Regist…
2012
Objective.To evaluate 4-year retention rates of tumor necrosis factor-α (TNF-α) inhibitors adalimumab, etanercept, and infliximab among patients with longstanding rheumatoid arthritis (RA), as derived from an Italian national registry.Methods.The clinical records of 853 adult patients with RA in the GISEA (Gruppo Italiano Studio Early Arthritis) registry were prospectively analyzed to compare drug survival rates and the baseline factors that may predict adherence to therapy.Results.In 2003 and 2004, 324 patients started treatment with adalimumab, 311 with etanercept, and 218 with infliximab. After 4 years, the global retention rate of anti-TNF-α therapy was 42%. Etanercept survival (51.4%) …
Changes in myocardial iron content following administration of intravenous iron (Myocardial‐IRON): Study design
2018
Treatment with intravenous ferric carboxymaltose (FCM) has been shown to improve symptoms, functional capacity, and quality of life in patients with heart failure and iron deficiency. However, the underlying mechanisms for these beneficial effects remain undetermined. The aim of this study is to quantify cardiac magnetic resonance changes in myocardial iron content after administration of intravenous FCM in patients with heart failure and iron deficiency and contrast them with parameters of heart failure severity. This is a multicenter, double-blind, randomized study. Fifty patients with stable symptomatic heart failure, left ventricular ejection fraction <50%, and iron deficiency will be r…
A randomized trial of intravitreal bevacizumab vs. ranibizumab for myopic CNV.
2014
AIMS: The aim was to compare the efficacy of intravitreal therapy with bevacizumab and ranibizumab for choroidal neovascularization (CNV) in pathologic myopia (PM). METHODS: This was a prospective multicenter randomized nonblinded trial. RESULTS: In seven centers, 78 eyes were randomized 1:1 to treatment with bevacizumab (group B, 40 eyes) or ranibizumab (group R, 38 eyes) given with an "on demand" regimen (PRN). The mean follow-up was 19 months (SD 2, range 12-24). The mean BCVA at baseline was 0.60 logMAR (20/80 Snellen equivalent, Seq) and 50 letter score (ls). Mean final BCVA was 0.51 LogMAR (20/63 Seq) and 57 ls (p = 0.0009 and p = 0.0002, respectively). In group B, mean basal BCVA was…
Prognostic implications of dipyridamole cardiac MR imaging: a prospective multicenter registry
2011
Purpose: To evaluate dipyridamole cardiac magnetic resonance (MR) imaging in the prediction of major events (MEs) in patients with ischemic chest pain in a large multicenter registry. Materials and Methods: Institutional ethics committee approval and written informed consent were obtained. A total of 1722 patients who were undergoing cardiac MR imaging for chest pain were included. Wall motion abnormalities (WMAs) at rest, hyperemia perfusion defect (PD), late gadolinium enhancement (LGE), and inducible WMA were analyzed (abnormal if more than one abnormal segment was seen) with the 17-segment model. A cardiac MR categorization was created: category 1, no PD, LGE, or inducible WMA; category…
Is Dexamethasone superior to Ketorolac in reducing pain, swelling and trismus following mandibular third molar removal? A split mouth triple-blind ra…
2021
Background The preemptive use of anti-inflammatory drugs, such as corticosteroids and NSAIDs, has the potential to reduce pain, swelling and trismus following oral surgery. The aim of this study was to compare the efficacy of dexamethasone and ketorolac tromethamine in reducing pain, swelling and trismus after mandibular third molar removal. Material and Methods The researches implemented a triple-blind, randomized clinical trial. The study was conducted with ASA I individuals aging between 18 and 35 years, which were randomized and submitted to two interventions, one with 8mg dexamethasone and the other with 20mg ketorolac tromethamine given 1h before the procedure. The primary predictor v…
Efficacy and tolerability of EH301 for amyotrophic lateral sclerosis: a randomized, double-blind, placebo-controlled human pilot study
2019
Background: Amyotrophic lateral sclerosis (ALS) is a devastating neurodegenerative disease, characterized by progressive loss of spinal and cortical motor neurons, leading to muscular atrophy, respiratory failure, and ultimately death. There is no known cure, and the clinical benefit of the two drugs approved to treat ALS remains unclear. Novel disease-modifying therapeutics that are able to modulate the disease course are desperately needed. Our objective was to evaluate the efficacy and tolerability of Elysium Health's candidate drug EH301 in people with ALS (PALS). Methods: This was a single-center, prospective, double-blind, randomized, placebo-controlled pilot study. Thirty-two PALS we…