Search results for "double-blind method"
showing 10 items of 631 documents
Dopamine agonist cabergoline reduces hemoconcentration and ascites in hyperstimulated women undergoing assisted reproduction.
2007
Abstract Context: Ovarian hyperstimulation syndrome (OHSS) results from increased vascular permeability (VP) caused by ovarian hypersecretion of vascular endothelial growth factor (VEGF), which activates its receptor-2. In animals, the dopamine receptor 2 agonist cabergoline (Cb2) inactivates VEGF receptor-2 and prevents increased VP. Objective: Our objective was to test whether Cb2 reduces VP and prevents OHSS in humans. Design: We conducted a prospective, randomized, double-blind study on oocyte donors at risk of developing OHSS (>20 follicles, >12 mm developed, and >20 oocytes retrieved). Interventions: Cb2 0.5 mg/d (n = 37) or a placebo (n = 32) was administered fro…
Polynitroxylated hemoglobin-based oxygen carrier: inhibition of free radical-induced microcirculatory dysfunction.
1999
Reactive oxygen species have been identified as key mediators of leukocyte/endothelial cell interaction under various pathological conditions and diseases such as ischemia/reperfusion injury, inflammation, and after exposure to cigarette smoke. Consequently, antioxidants have been shown to successfully prevent the sequelae of these conditions, ranging from tissue infarction to atherogenesis. In this study we investigated whether, via its established superoxide dismutase-like activity, a novel polynitroxyl hemoglobin-based oxygen carrier (PNH), could affect the stimulation of leukocyte rolling and adhesion to endothelial cells in response to cigarette smoke. Using the dorsal skin fold chambe…
Food of the Gods for the Treatment of Multiple Sclerosis Related Fatigue?
2019
In their JNNP paper, Coe et al report the preliminary results of a feasibility trial on flavonoid enriched cocoa for the treatment of multiple sclerosis (MS) related fatigue, showing promising results that encourage the conduction of a phase III clinical trial to confirm the results of possible clinical effects on MS related fatigue.1 As described in the paper,1 fatigue is the most common symptom reported by individuals affected by MS, affecting the majority of patients. It is often present even when neurological disability is low and in the early stages of the disease, but impacts significantly the quality of life in MS patients, diminishing independence in everyday activities. Fatigue sym…
The role of red yeast rice (RYR) supplementation in plasma cholesterol control: A review and expert opinion.
2019
1. Preamble : Hypercholesterolemia is a major risk factor for atherosclerotic cardiovascular disease (ASCVD) [1]. Increased levels of low density lipoprotein cholesterol (LDL-C) are associated with an increased risk of coronary heart disease (CHD) and many clinical trials have shown that reducing LDL-C levels significantly reduced the CHD and CVD risk [[2], [3], [4], [5]]. Thus LDL-C-lowering is the main approach for the management of cardiovascular disease. Current guidelines suggest LDL-C levels targets based on the individual CV risk; such targets can be achieved by several means, which include both lifestyle changes and pharmacological approaches [6], with statins being the cornerstone …
Root coverage with connective tissue graft associated with coronally advanced flap or tunnel technique: a randomized, double-blind, mono-centre clini…
2016
Aim: The aim of this randomized clinical trial was to compare the coronally advanced flap (CAF) with the modified microsurgical tunnel technique (MMTT) for treatment of Miller class I and II recessions. Material and Methods: Forty patients with 71 gingival recessions were recruited and randomly assigned to either CAF or to MMTT. In both groups, a connective tissue graft was applied. Clinical evaluations were performed after 3, 6, and 12 months. Impressions were taken and digitally scanned three-dimensionally to evaluate the quantitative soft tissue changes in the operative region. Patient satisfaction was measured with the root coverage aesthetic score (RES). Results: After a period of 12 m…
Safety and efficacy of a probiotic-containing infant formula supplemented with 2'-fucosyllactose: a double-blind randomized controlled trial
2022
Abstract Background Human milk oligosaccharides (HMOs) have important and diverse biological functions in early life. This study tested the safety and efficacy of a starter infant formula containing Limosilactobacillus (L.) reuteri DSM 17938 and supplemented with 2’-fucosyllactose (2’FL). Methods Healthy infants < 14 days old (n = 289) were randomly assigned to a bovine milk-based formula containing L. reuteri DSM 17938 at 1 × 107 CFU/g (control group; CG) or the same formula with added 1.0 g/L 2’FL (experimental group; EG) until 6 months of age. A non-randomized breastfed group served as reference (BF; n = 60). The primary endpoint was weight gain through 4 months of age in the formula-…
Reduced inotropic support after aprotinin therapy during pediatric cardiac operations
1999
Several reports indicate that aprotinin treatment before and during cardiopulmonary bypass (CPB) might have a protective effect on the myocardium. We evaluated the hemodynamic effects of perioperative aprotinin treatment.We conducted a randomized, double-blind, placebo-controlled trial in 34 infants (mean age, 2.5 years) who had cardiac operations. Half of the patients received high-dose aprotinin therapy. There were no significant differences between the aprotinin and placebo groups with respect to age, weight, sex, aortic cross-clamp time, and CPB time. The following data were recorded at arrival in the intensive care unit 6, 12, 24, and 48 hours after termination of CPB: heart rate, bloo…
Repetitive use of LEvosimendan in Ambulatory Heart Failure patients (LEIA-HF) - The rationale and study design
2022
Abstract Purpose Clinical practice forces the necessity to conduct a clinical trial concerning the group of outpatients with chronically advanced heart failure in III or IV NYHA functional class, frequently requiring hospitalizations due to HF exacerbation, and often left without any additional therapeutic option. The current trial aims to determine the efficacy and safety of repeated levosimendan infusions in the group of severe outpatients with reduced ejection fraction (HFrEF). Material and methods LEIA-HF (LEvosimendan In Ambulatory Heart Failure Patients) is a multicentre, randomized, double-blind, placebo-controlled, phase 4 clinical trial to determine whether the repetitive use of le…
How bilastine is used to treat allergic rhinitis and urticaria in children
2021
Management guidelines for allergic rhinitis and urticaria recommend oral second-generation antihistamines as first-line treatment. The efficacy and safety of bilastine, the newest nonsedating second-generation antihistamine, are well established in adolescents/adults with these allergic conditions. The bilastine development program for pediatric use (2–<12 years) followed EMA-authorized processes. Pharmacokinetic/pharmacodynamic simulation and modeling and a pharmacokinetic study were conducted to identify and confirm the pediatric dose (10 mg/day). A Phase III, multicenter, double-blind, randomized, placebo-controlled, parallel-group study was performed to confirm the safety of bilasti…
Effects of bovine colostrum supplementation on serum IGF-I, IgG, hormone, and saliva IgA during training.
1997
Mero, Antti, Heidi Miikkulainen, Jarmo Riski, Raimo Pakkanen, Jouni Aalto, and Timo Takala. Effects of bovine colostrum supplementation on serum IGF-I, IgG, hormone, and saliva IgA during training. J. Appl. Physiol.83(4): 1144–1151, 1997.—The purpose of this study was to examine the effects of bovine colostrum supplementation (Bioenervi) on serum insulin-like growth factor I (IGF-I), immunoglobulin G, hormone, and amino acid and saliva immunoglobulin A concentrations during a strength and speed training period. Nine male sprinters and jumpers underwent three randomized experimental training treatments of 8 days separated by 13 days. The only difference in the treatments was the drink of 125…