Search results for "double-blind"
showing 10 items of 662 documents
Effects of amino acids supplement on physiological adaptations to resistance training.
2009
KRAEMER, W. J., D. L. HATFIELD, J. S. VOLEK, M. S. FRAGALA, J. L. VINGREN, J. M. ANDERSON, B. A. SPIERING, G. A. THOMAS, J. Y. HO, E. E. QUANN, M. IZQUIERDO, K. HAKKINEN, and C. M. MARESH. Effects of Amino Acids Supplement on Physiological Adaptations to Resistance Training. Med. Sci. Sports Exerc., Vol. 41, No. 5, pp. 1111-1121, 2009. Introduction: Previous research has demonstrated that ingestion of essential amino acids and their metabolites induce anabolic effects with the potential to augment gains in lean body mass and strength after resistance exercise training. Purpose: The purpose of the present study was to examine the effects of an essential amino acid-based formula (Muscle Armor…
Micafungin versus liposomal amphotericin B for candidaemia and invasive candidosis: a phase III randomised double-blind trial
2007
Summary Background Invasive candidosis is increasingly prevalent in seriously ill patients. Our aim was to compare micafungin with liposomal amphotericin B for the treatment of adult patients with candidaemia or invasive candidosis. Methods We did a double-blind, randomised, multinational non-inferiority study to compare micafungin (100 mg/day) with liposomal amphotericin B (3 mg/kg per day) as first-line treatment of candidaemia and invasive candidosis. The primary endpoint was treatment success, defined as both a clinical and a mycological response at the end of treatment. Primary analyses were done on a per-protocol basis. This trial is registered with ClinicalTrials.gov, number NCT00106…
German randomized double-blind multicentre comparison of terbinafine and itraconazole for the treatment of toenail tinea infection
1996
Summary One–hundred and ninety–five patients with toenail tinea unguium were recruited to a multicentre double–blind clinical trial. Patients were given 250mg terbinafine or 200 mg itraconazole daily for 12 weeks, with follow–up for a further 40 weeks. At the end of the study, mycological cure rates were 81% (70/86 assessed) for terbinafine and 63% (53/84 assessed) for itraconazole (two–tailed, P < 0·05). The length of unaffected nail was 9·44 mm in the terbinafine group and 7·85 mm in the itraconazole group (two–tailed, P < 0·05). Patient self–assessment also favoured terbinafine, with 65% evaluating it as good to very good, compared with 58% for itraconazole. Before treatment the terbinaf…
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…