Search results for "Double-Blind Method"
showing 10 items of 631 documents
Antiinflammatory Therapy with Canakinumab for Atherosclerotic Disease
2017
Background: Experimental and clinical data suggest that reducing inflammation without affecting lipid levels may reduce the risk of cardiovascular disease. Yet, the inflammatory hypothesis of atherothrombosis has remained unproved. Methods: We conducted a randomized, double-blind trial of canakinumab, a therapeutic monoclonal antibody targeting interleukin-1β, involving 10,061 patients with previous myocardial infarction and a high-sensitivity C-reactive protein level of 2 mg or more per liter. The trial compared three doses of canakinumab (50 mg, 150 mg, and 300 mg, administered subcutaneously every 3 months) with placebo. The primary efficacy end point was nonfatal myocardial infarction, …
Impact of colonic fermentation on sterols after the intake of a plant sterol-enriched beverage: A randomized, double-blind crossover trial
2017
Summary Background Cholesterol microbial transformation has been widely studied using in vitro fermentation assays, but less information is available on the biotransformation of plant sterols (PS). The excretion percentage of animal sterols (AS) (67–73%) is considerably greater than that of PS (27–33%) in feces from healthy humans following a Western diet. However, a lower content of AS in feces from subjects following a vegetarian, vegan or low-fat animal diet has been seen when compared to omnivorous subjects. Although only one human study has reported fecal sterol excretion after the consumption of PS-enriched food (8.6 g PS/day), it was found that the target group showed an increase in …
A single preoperative pain neuroscience education: Is it an effective strategy for patients with carpal tunnel syndrome?
2019
Patients undergoing carpal tunnel release surgery may continue to experience pain despite the intervention. This symptom may be modulated by psychosocial factors including depression, catastrophic thinking, and kinesiophobia. Pain neuroscience education (PNE) has been found to be effective when combined with therapeutic exercise in patients with chronic pain, but this strategy has not been evaluated in patients with persistent hand pain. The findings of this study indicate that a single preoperative PNE session in combination with therapeutic exercise does not provide added benefits in comparison to standard preoperative care plus therapeutic exercise. Future studies should evaluate if pati…
Effects of the flavonol quercetin and α-linolenic acid on n-3 PUFA status in metabolically healthy men and women: a randomised, double-blinded, place…
2017
AbstractIncreased dietary intake and tissue status of the long-chainn-3 PUFA, EPA and DHA, is associated with cardiovascular benefits. Epidemiological and animal studies suggest that concomitant nutritive intake of flavonoids may increase the conversion ofα-linolenic acid (ALA) to longer-chainn-3 fatty acids EPA and DHA. We investigated the effects of increased ALA intake on fatty acid composition of serum phospholipids and erythrocytes in metabolically healthy men and women and whether fatty acid profiles and ALA conversion were affected by regular quercetin intake or sex. Subjects (n74) were randomised to receive at least 3·3 g/d ALA with either 190 mg/d quercetin (ALA+quercetin) or place…
Double-Blind, Placebo-Controlled, Randomized Trial of Selenium in Graves Hyperthyroidism.
2017
Abstract Context Supplemental selenium (Se) may affect the clinical course of Graves disease (GD). Objective Evaluate efficacy of add-on Se on medical treatment in GD. Design Double-blind, placebo-controlled, randomized supplementation trial. Setting Academic endocrine outpatient clinic. Patients Seventy untreated hyperthyroid patients with GD. Intervention Additionally to methimazole (MMI), patients received for 24 weeks either sodium selenite 300 µg/d po or placebo. MMI was discontinued at 24 weeks in euthyroid patients. Main Outcome Measures Response rate (week 24), recurrence rate (week 36), and safety. Results A response was registered in 25 of 31 patients (80%) and in 27 of 33 (82%) a…
An Acute Dose of Specific Grape and Apple Polyphenols Improves Endurance Performance: A Randomized, Crossover, Double-Blind versus Placebo Controlled…
2017
International audience; Polyphenols are thought to be an interesting ergogenic aid for exercise and recovery. However, most studies regarding the effects of polyphenols investigated several days of supplementations. The present work aimed to study the effects of an acute intake of grape and apple polyphenols on the capacity to maintain intense exercise, here named endurance performance. Forty-eight physically active men (31 ± 6 years) were included in this study. During the two testing sessions, volunteers completed an endurance test at a high percentage of their maximal aerobic power and time to exhaustion was measured. Respiratory and pain parameters were also monitored. The preceding eve…
Safety of Novel Amino-5-laevulinate Photosensitizer Precursors in Photodynamic Therapy for Healthy Human Skin.
2015
Peer reviewed
A 300 IR sublingual tablet is an effective, safe treatment for house dust mite-induced allergic rhinitis: An international, double-blind, placebo-con…
2021
Background: Allergic rhinitis induced by house dust mites (HDMs) is a highly prevalent but often underdiagnosed and undertreated/untreated chronic disease. It often has a negative impact on sleep, work, leisure activities, and health-related quality of life. Allergen immunotherapy is a proven, safe treatment for respiratory allergies. Objective: We sought to assess the efficacy and safety of a 300 index of reactivity (IR) sublingual tablet formulation of Dermatophagoides pteronyssinus:Dermatophagoides farinae 1:1 extract in adolescents (aged >_12) and adults with moderate to severe HDM-induced allergic rhinitis. Methods: In a phase III, international, double-blind, placebo controlled, rando…
A positive impact on the serum lipid profile and cytokines after the consumption of a plant sterol-enriched beverage with a milk fat globule membrane…
2018
The hypocholesterolemic effect and the modification of serum biomarkers of a dietary plant sterol (PS) intake, cholesterol precursors and cytokines after the consumption of milk-based fruit beverages with a milk fat globule membrane were evaluated by a randomized, double-blind, crossover, multiple dose bioavailability study. Postmenopausal women (n = 38) consumed daily 250 mL of a beverage with or without 2 g of PS added during 6 weeks in each of the study periods. With the intake of the PS-added beverage, significant decreases (mg dL-1) in serum total cholesterol (pre-treatment: 220.0 ± 27.8 vs. post-treatment: 212.9 ± 25.8; p < 0.05) and LDL-cholesterol (129.4 ± 28.5 vs. 121.7 ± 24.4; p <…
A randomized, placebo-controlled trial of cenicriviroc for treatment of nonalcoholic steatohepatitis with fibrosis
2018
The aim of this study was to evaluate cenicriviroc (CVC), a dual antagonist of C-C chemokine receptor types 2 and 5, for treatment of nonalcoholic steatohepatitis (NASH) with liver fibrosis. A randomized, double-blind, multinational phase 2b study enrolled subjects with NASH, a nonalcoholic fatty liver disease activity score [NAS] ≥4, and liver fibrosis (stages 1-3, NASH Clinical Research Network) at 81 clinical sites. Subjects (N = 289) were randomly assigned CVC 150 mg or placebo. Primary outcome was ≥2-point improvement in NAS and no worsening of fibrosis at year 1. Key secondary outcomes were: resolution of steatohepatitis and no worsening of fibrosis; improvement in fibrosis by ≥1 stag…