Search results for "double-blind method"

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 …

Efficacy and Safety of Alirocumab in Reducing Lipids and Cardiovascular Events

2015

BACKGROUND: Alirocumab, a monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9), has been shown to reduce low-density lipoprotein (LDL) cholesterol levels in patients who are receiving statin therapy. Larger and longer-term studies are needed to establish safety and efficacy.METHODS: We conducted a randomized trial involving 2341 patients at high risk for cardiovascular events who had LDL cholesterol levels of 70 mg per deciliter (1.8 mmol per liter) or more and were receiving treatment with statins at the maximum tolerated dose (the highest dose associated with an acceptable side-effect profile), with or without other lipid-lowering therapy. Patients were …

Decreased plasma soluble RAGE in patients with hypercholesterolemia: Effects of statins

2007

The receptor for advanced glycation endproducts (RAGE) is overexpressed at sites of vascular pathology. A soluble RAGE isoform (sRAGE) neutralizes the ligand-mediated damage by acting as a decoy. We hypothesized that in hypercholesterolemia up-regulation of the ligand-RAGE axis may bridge impairment of nitric oxide biosynthesis with oxidative stress. We measured in 60 hypercholesterolemic patients and 20 controls plasma total sRAGE levels, urinary 8-iso-prostaglandin (PG) F(2alpha) excretion, and plasma levels of asymmetric dimethylarginine (ADMA). The effects of two structurally different statins (pravastatin and atorvastatin) on these parameters were analyzed in 20 hypercholesterolemic su…

Flow-mediated dilation in patients with coronary artery disease is enhanced by high dose atorvastatin compared to combined low dose atorvastatin and …

2009

Abstract Background Effects independent from cholesterol reduction on vascular function are considered to importantly contribute to the beneficial effects of statin therapy in cardiovascular disease. We aimed to evaluate the effect of high versus low dose atorvastatin on endothelial dysfunction in patients with coronary artery disease (CAD) in a setting of comparable cholesterol reduction. Methods and results Fifty-eight patients with CAD were randomly assigned to double-blind treatment for 8 weeks with atorvastatin 80mg per day (A80) or atorvastatin 10mg+ezetimibe 10mg per day (A10E10), respectively. Flow-mediated vasodilation (FMD) of the brachial artery, nitroglycerin-mediated endotheliu…

Influence of HMB Supplementation and Resistance Training on Cytokine Response to Resistance Exercise

2014

The purpose of this study was to determine the effects of a multinutritional supplement including amino acids, β-hydroxy-β-methylbutyrate (HMB), and carbohydrates on cytokine responses to resistance exercise and training.Seventeen healthy, college-aged men were randomly assigned to a Muscle Armor™ (MA; Abbott Nutrition, Columbus, OH) or placebo supplement group and 12 weeks of resistance training. An acute resistance exercise protocol was administered at 0, 6, and 12 weeks of training. Venous blood samples at pre-, immediately post-, and 30-minutes postexercise were analyzed via bead multiplex immunoassay for 17 cytokines.After 12 weeks of training, the MA group exhibited decreased interfer…

Clinic modelling randomised trials (CMRT's) in animals as a new intermediate between biological experiments and randomised clinical trials: applicati…

1998

Epidural ropivacaine -- where are the benefits? A prospective, randomized, double-blind trial in patients with retropubic prostatectomy.

2007

Background:  In comparison with bupivacaine, ropivacaine exhibits comparable anaesthetic effects but with less motor impairment and systemic toxicity. However, the analgesic potency may differ. For example, ropivacaine during obstetric epidural analgesia provides an approximately 40% lower analgesic potency than bupivacaine. Equal visual analogue pain scores require significantly higher dosages of ropivacaine, and general statements about a favourable benefit–risk profile relative to that of bupivacaine may therefore have limited clinical impact. We addressed this topic in a male pain model by evaluating the analgesic efficacy of epidural ropivacaine 0.2% vs. bupivacaine 0.125% after retrop…

Pancreatic enzyme therapy in childhood celiac disease. A double-blind prospective randomized study.

1995

The validity of pancreatic enzyme substitution therapy in the two months following diagnosis of celiac disease was investigated. Twenty patients (8 males, 12 females), mean age 14.2 months (group A) received an enzyme substitution preparation. The control group (group B) included 20 patients (9 males, 11 females), mean age 14.5 months, treated with placebo. Before starting treatment, we performed a stratification for age, weight-for-age at diagnosis, and degree of pancreatic insufficiency. The therapies were then administered randomly in double-blind fashion. On diagnosis and 30 and 60 days after commencement of a gluten-free diet with identical calorie intake in both groups, a series of an…