Search results for "double-blind method"
showing 10 items of 631 documents
Reduction of low-density lipoprotein cholesterol in patients with coronary heart disease and metabolic syndrome: analysis of the Treating to New Targ…
2006
BACKGROUND: Despite the prognostic value of metabolic syndrome for predicting cardiovascular events, few trials have investigated the effects of statin therapy on cardiovascular morbidity and mortality in patients with the metabolic syndrome. Our post hoc analysis of the Treating to New Targets (TNT) study assessed whether intensive lowering of low-density lipoprotein cholesterol with high-dose atorvastatin therapy results in cardiovascular benefits for patients with both coronary heart disease and the metabolic syndrome. METHODS: The TNT study was a prospective, double blind, parallel-group trial done at 256 sites in 14 countries between April, 1998, and August, 2004, with a median follow-…
Effects of nebivolol and atenolol on central aortic pressure in hypertensive patients: a multicenter, randomized, double-blind study.
2013
The main objective was to compare the mean change in augmentation index of hypertensive patients treated with nebivolol or atenolol.Multicenter, double-blind randomized study conducted in six Spanish centers. We enrolled outpatients between the ages of 40 and 65 years with mild or moderate essential hypertension (systolic blood pressure, SBP ≥ 140 mmHg to ≤ 179 mmHg and diastolic blood pressure, DBP ≥ 90 mmHg to ≤ 109 mmHg after a 2-week run-in placebo period). Patients received nebivolol 5 mg or atenolol 50 mg once daily. At week 3, atenolol could be titrated up to 100 mg qd for non-responders. Additionally, patients not achieving normal blood pressure after 6 weeks could be treated with 2…
Use of a new cross-linked collagen membrane for the treatment of dehiscence-type defects at titanium implants: a prospective, randomized-controlled d…
2009
OBJECTIVES The aim of the present randomized-controlled double-blinded clinical multicenter study was to assess the use of either a new cross-linked (VN) or a native collagen membrane (BG) for the treatment of dehiscence-type defects at titanium implants. MATERIAL AND METHODS A total of n=54 patients were recruited in four German university clinics. According to a parallel-groups design, dehiscence-type defects at titanium implants were filled with a natural bone mineral and randomly assigned to either VN or BG. Submerged sites were allowed to heal for 4 months. Primary (e.g., changes in defect length - DeltaDL, quality of newly formed tissue [0-4] - TQ) and secondary parameters (e.g., memb…
Improvement of wound healing after hemorrhoidectomy: a double-blind, randomized study of botulinum toxin injection.
2005
PURPOSE: Hemorrhoidectomy is usually associated with significant pain during the postoperative period. The spasm of the internal sphincter seems to play in important role in the origin of pain. This study was designed to evaluate the effectiveness of intrasphincter injection of botulinum toxin after hemaorrhoidectomy in reducing the maximum testing pressure of the anal canal, accelerating wound healing, and decreasing postoperative pain when resting and during defecation. METHODS: Thirty patients with hemorrhoids of third and fourth degree were included in the study and randomized in two groups. Anorectal manometry was performed preoperatively and 5 and 30 days afterward ill all patients un…
Acute effects of coffee on QT interval in healthy subjects
2011
Abstract The coronary endothelial function is recognized to have an important role in the physiology of the diastolic ventricular relaxation, a phase of the heart cycle that influences the electrocardiographic QT interval. Endothelial function is investigated in vivo by flow mediated dilation (FMD) in the brachial artery and has proven to be a strong predictor of both coronary endothelial function and cardiovascular events. It has been reported that coffee acutely induces FMD changes. In particular, the brachial artery FMD seems to decrease after caffeinated coffee (CC) and to increase after decaffeinated coffee (DC) ingestion. Since the cardiovascular effects of coffee are still a debated …
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…