Search results for "double"
showing 10 items of 2879 documents
A Phase 3 Trial of Sebelipase Alfa in Lysosomal Acid Lipase Deficiency
2015
BackgroundLysosomal acid lipase is an essential lipid-metabolizing enzyme that breaks down endocytosed lipid particles and regulates lipid metabolism. We conducted a phase 3 trial of enzyme-replacement therapy in children and adults with lysosomal acid lipase deficiency, an underappreciated cause of cirrhosis and severe dyslipidemia. MethodsIn this multicenter, randomized, double-blind, placebo-controlled study involving 66 patients, we evaluated the safety and effectiveness of enzyme-replacement therapy with sebelipase alfa (administered intravenously at a dose of 1 mg per kilogram of body weight every other week); the placebo-controlled phase of the study was 20 weeks long and was followe…
Anti–Interleukin-12 Antibody for Active Crohn's Disease
2004
Crohn's disease is associated with excess cytokine activity mediated by type 1 helper T (Th1) cells. Interleukin-12 is a key cytokine that initiates Th1-mediated inflammatory responses.This double-blind trial evaluated the safety and efficacy of a human monoclonal antibody against interleukin-12 (anti-interleukin-12) in 79 patients with active Crohn's disease. Patients were randomly assigned to receive seven weekly subcutaneous injections of 1 mg or 3 mg of anti-interleukin-12 per kilogram of body weight or placebo, with either a four-week interval between the first and second injection (Cohort 1) or no interruption between the two injections (Cohort 2). Safety was the primary end point, an…
Mycophenolate plus methylprednisolone versus methylprednisolone alone in active, moderate-to-severe Graves' orbitopathy (MINGO): a randomised, observ…
2018
BACKGROUND: European guidelines recommend intravenous methylprednisolone as first-line treatment for active and severe Graves' orbitopathy; however, it is common for patients to have no response or have relapse after discontinuation of treatment. We aimed to compare the efficacy and safety of add-on mycophenolate to methylprednisolone in comparison with methylprednisolone alone in patients with moderate-to-severe Graves' orbitopathy.METHODS: MINGO was an observer-masked, multicentre, block-randomised, centre-stratified trial done in two centres in Germany and two in Italy. Patients with active moderate-to-severe Graves' orbitopathy were randomly assigned to receive intravenous methylprednis…
Effect of Kinesio Taping and balance exercises on postural control in amateur soccer players: A randomised control trial
2019
The objective of this study was to determine the effect of Kinesio Taping (KT), alone or together with balance exercises (BE), on parameters related to postural control, such as dynamic balance, static balance and flexibility. Forty-four male amateur soccer players (mean age 24.45 (4.79) years) were randomly allocated to 3 groups: KT+BE that received KT and BE (n = 16); KT
Effects of intraocular cefotaxime on the human corneal endothelium
2001
Abstract Purpose To ascertain whether 0.4 mL of cefotaxime 0.25% applied intracamerally causes toxic alteration of the human corneal endothelium. Methods In this prospective randomized masked study, 66 patients had cataract extraction using phacoemulsification, a frown incision, and implantation of a poly(methyl methacrylate) intraocular lens. This was followed by intraocular injection of 0.4 mL of cefotaxime 0.25% or balanced salt solution (BSS®). Contact specular microscopy and photography were performed preoperatively and 1 to 4 days and 3 months postoperatively. Results In the cefotaxime group, the mean endothelial cell count was 2729 cells/mm 2 ± 474 (SD) preoperatively, 2520 ± 462 cel…
Dose-response relationships and plasma concentrations of digitalis glycosides in man.
1978
An inter-individual, randomized, double-blind study of digitoxin (Dt) and β-acetyl digoxin (D) was performed in 120 healthy male volunteers. Groups of 10 persons each received orally D 0, 0.1, 0.2, 0.3, 0.4, 0.5 or 0.6 mg and Dt 0.04, 0.08, 0.12, or 0.16 mg daily for 7 days; Loading doses were given for the first three days. Plasma levels were measured with an86Rb-erythrocyte assay 24 h after the last dose. ECG, carotid artery pulse and phonocardiogram were recorded prior to (b) and 24 h after (a) the last dose. QTc, amplitude of T-waves in V2 to V6, electromechanical systole (QS2c) and left ventricular ejection time (LVETc) were measured. The differences between a and b (Δ-values) reflect …
Effects of transcranial direct current stimulation on esophageal motility in patients with gastroesophageal reflux disease
2014
To evaluate the effects of transcranial direct current stimulation (tDCS) on esophageal peristalsis in patients with gastroesophageal reflux disease (GERD).Patients with GERD preliminary diagnosis were included in a randomized double-blind sham-controlled study. Esophageal manometry was performed before and during transcranial direct current stimulation (tDCS) of the right precentral cortex. Half of patients were randomly assigned to anodal, half to sham stimulation. Distal waves amplitude and pathological waves percentage were measured, after swallowing water boli, for ten subsequent times. Last, a 24h pH-bilimetry was done to diagnose non-erosive reflux disease (NERD) or functional heartb…
Assessment of the long-term safety of mepolizumab and durability of clinical response in patients with severe eosinophilic asthma
2018
Background Mepolizumab has demonstrated favorable safety and efficacy profiles in placebo-controlled trials of 12 months' duration or less; however, long-term data are lacking. Objective We sought to evaluate the long-term safety and efficacy of mepolizumab in patients with severe eosinophilic asthma (SEA). Methods COLUMBA (Open-label Long Term Extension Safety Study of Mepolizumab in Asthmatic Subjects, NCT01691859 ) was an open-label extension study in patients with SEA previously enrolled in DREAM (Dose Ranging Efficacy And Safety With Mepolizumab in Severe Asthma, NCT01000506 ). Patients received 100 mg of subcutaneous mepolizumab every 4 weeks plus standard of care until a protocol-def…
Effect of alpha-linolenic acid in combination with the flavonol quercetin on markers of cardiovascular disease risk in healthy, non-obese adults: A r…
2019
Abstract Objectives Alpha-linolenic acid (ALA) and quercetin are characteristic compounds in plant-based diets. Cardioprotective effects have been described for both substances, although a possible benefit of combining ALA and quercetin has not, to our knowledge, been evaluated yet. The aim of this study was to investigate the potential independent and additive effects of ALA and quercetin on blood pressure (BP) and lipid and glucose metabolism, as well as on biomarkers of inflammation, oxidative stress, and antioxidant status in healthy, non-obese men and women. Another aim was to examine whether chronic supplementation of supranutritional doses of quercetin would result in an accumulation…
Coadministration of atorvastatin prevents nitroglycerin-induced endothelial dysfunction and nitrate tolerance in healthy humans.
2010
Objectives We aimed to assess whether concurrent administration of atorvastatin would modify the development of tolerance and endothelial dysfunction associated with sustained nitroglycerin (GTN) therapy in humans. Background Animal studies have demonstrated that administration of 3-hydroxy-3 methylglutaryl coenzyme A reductase inhibitors can protect against GTN-induced endothelial dysfunction and tolerance, likely through an antioxidant mechanism. Methods Thirty-six healthy male volunteers were randomized to receive continuous transdermal GTN (0.6 mg/h) and placebo, atorvastatin (80 mg/day) alone, or continuous transdermal GTN (0.6 mg/h) with concurrent atorvastatin (80 mg/day), all for 7 …