Search results for "Double-Blind"
showing 10 items of 662 documents
Growth and safety evaluation of infant formulae containing oligosaccharides derived from bovine milk: a randomized, double-blind, noninferiority trial
2014
A limited number of nondigestible oligosaccharides are available for use in infant formula. This study evaluated growth and safety in infants fed formula supplemented with a mixture of bovine milk-derived oligosaccharides (BMOS). This mixture, which was generated from whey permeate, contains galactooligosaccharides and other oligosaccharides from bovine milk, such as 3′- and 6′-sialyllactose. We hypothesized that growth in infants fed BMOS-supplemented formula would be noninferior to that in infants fed standard formula. Healthy term infants ≤14 days old were randomly assigned to standard formula (control; n = 84); standard formula with BMOS (IF-BMOS; n = 99); or standard formula with BMOS …
Intolerance of Cow's Milk and Chronic Constipation in Children
1998
Background Chronic diarrhea is the most common gastrointestinal symptom of intolerance of cow's milk among children. On the basis of a prior open study, we hypothesized that intolerance of cow's milk can also cause severe perianal lesions with pain on defecation and consequent constipation in young children. Methods We performed a double-blind, crossover study comparing cow's milk with soy milk in 65 children (age range, 11 to 72 months) with chronic constipation (defined as having one bowel movement every 3 to 15 days). All had been referred to a pediatric gastroenterology clinic and had previously been treated with laxatives without success; 49 had anal fissures and perianal erythema or e…
Effects of nicotinamide adenine dinucleotide hydride on physical and mental performance
2007
The aim of this study was to assess the effects of nicotinamide adenine dinucleotide hydride (NADH) on maximal oxygen uptake (VO2max), maximal anaerobic running time, and mental performance. Eight men were exposed to a supplement treatment (30 mg NADH as ENACHI tablets per day) and to a placebo treatment, each of 4 weeks' duration, in a balanced, double-blind, and cross-over design. The two treatments were separated by a 14-week wash-out period. The results indicated that VO2max, maximal anaerobic running time, and the ability to concentrate were similar in the NADH and placebo conditions. There were also no differences in blood lactate, creatine kinase, reaction time or feelings of fatigue…
Efficacy of delayed thromboprophylaxis with dabigatran: Pooled analysis
2012
Abstract Introduction Oral thromboprophylaxis with dabigatran etexilate should be initiated as a half dose 1 to 4 h after major orthopaedic surgery. However, a delay in dosing could occur for clinical or logistical reasons. A post hoc analysis was carried out to determine if patients with delayed dosing received adequate anticoagulation. Patients and methods The RE-MODEL™ and RE-NOVATE® trials compared 220 mg and 150 mg dabigatran etexilate with 40 mg enoxaparin. Pooled data for major venous thromboembolism (VTE) and VTE-related mortality (efficacy outcome) and major bleeding events (MBE), MBE/clinically relevant bleeding events, and all bleeding events (safety outcomes) were analysed. Resu…
Efficacy of the long-acting nitro vasodilator pentaerithrityl tetranitrate in patients with chronic stable angina pectoris receiving anti-anginal bac…
2013
Background The organic nitrate pentaerithrityl tetranitrate (PETN) has been shown to have ancillary properties that prevent the development of tolerance and endothelial dysfunction. This randomized, double-blind, placebo-controlled, multicentre study (‘CLEOPATRA’ study) was designed to investigate the anti-ischaemic efficacy of PETN 80 mg b.i.d. (morning and mid-day) over placebo in patients with chronic stable angina pectoris. Methods and results A total of 655 patients were evaluated in the intention-to-treat population, randomized to PETN (80 mg b.i.d., n = 328) or placebo ( n = 327) and completed the study. Patients underwent treadmill exercise tests at randomization, after 6 and 12 wee…
Mucositis in irradiated cancer patients: effects of an antiseptic mouthrinse.
2009
Objective: To assess the effects of an antiseptic, non-alcohol based mouth-rinse containing chlorhexidine and cetylpyridinium chloride, in preventing the oral complications associated to radiation therapy in head-and-neck cancer patients. Study design: This was a parallel, double blind, prospective, randomized clinical trial. Cancer patients were randomly assigned to one of the two treatments (test mouth-rinse or a placebo). Three visits were scheduled (baseline, 14 and 28 days). Different outcome variables were evaluated: mucositis, plaque and gingival indices, stimulated saliva and salivary pH. Results: 70 patients were screened and 36 were included. The presence and the degree of mucosit…
Efficacy and safety of ezetimibe added to atorvastatin versus atorvastatin uptitration or switching to rosuvastatin in patients with primary hypercho…
2013
Hypercholesterolemic patients (n = 1,547) at high atherosclerotic cardiovascular disease risk with low-density lipoprotein cholesterol (LDL-C) levels ≥100 and ≤160 mg/dl while treated with atorvastatin 10 mg/day entered a multicenter, randomized, double-blind, active-controlled, clinical trial using two 6-week study periods. Period I compared the efficacy/safety of (1) adding ezetimibe 10 mg (ezetimibe) to stable atorvastatin 10 mg, (2) doubling atorvastatin to 20 mg, or (3) switching to rosuvastatin 10 mg. Subjects in the latter 2 groups who persisted with elevated LDL-C levels (≥100 and ≤160 mg/dl) after period I, entered period II; subjects on atorvastatin 20 mg had ezetimibe added to th…
Food intolerance and chronic constipation: manometry and histology study
2006
BACKGROUND: Chronic constipation in children can be caused by cows' milk intolerance (CMI), but its pathogenesis is unknown. AIMS: To evaluate the histology and manometry pattern in patients with food intolerance-related constipation. PATIENTS AND METHODS: Thirty-six consecutive children with chronic constipation were enrolled. All underwent an elimination diet and successive double-blind food challenge. All underwent rectal biopsy and anorectal manometry. RESULTS: A total of 14 patients were found to be suffering from CMI and three from multiple food intolerance. They had a normal stool frequency on elimination diet, whereas constipation recurred on food challenge. The patients with food i…
The "red umbilicus": a diagnostic sign of cow's milk protein intolerance
2006
Introduction: Red umbilicus is considered to be an infectious disease typical of neonates. In our experience, umbilical erythema could be due to cow's milk protein intolerance (CMPI). Aims: To evaluate the frequency and clinical significance of umbilical erythema in a series of consecutive children referred for suspected CMPI. Patients and Methods: Seven hundred ninety-six consecutive patients (median age, 18 months) referred for suspected CMPI diagnosis were studied. CMPI diagnosis was based on the disappearance of symptoms on elimination diet and their subsequent reappearance on double-blind placebo-controlled cow's milk challenge. Results: CMPI was diagnosed in 384 patients: 120 with res…
Troponin I release after intravenous treatment with high furosemide doses plus hypertonic saline solution in decompensated heart failure trial (Tra-H…
2012
Background High values of cardiac troponin in acute decompensated congestive heart failure (ADHF) identify patients at higher risk and worsened prognosis. A cardiac troponin increase during therapy indicates the need for more appropriate intervention, aimed at compensating cardiac disease and effectively minimizing myocardial wall stress and subsequent cytolysis. This study evaluated the effects of an intravenous high dose of furosemide with (group A) or without small volume hypertonic saline solution (HSS) (group B) on myocardial cytolysis in patients with ADHF. Methods A total of 248 consecutive patients with ADHF (148 men, mean age 74.9 ± 10.9 years) were randomly assigned to group A or …