Search results for "double-blind method"
showing 10 items of 631 documents
Omalizumab (Xolair®) improves quality of life in adult patients with allergic asthma: a review
2003
Abstract Physicians are increasingly aware that asthma causes significant impairment of the patient's physical, psychological, and social well-being. Whilst standard clinical endpoints provide significant information on airway status during treatment, it is important to determine whether such improvements overcome the functional impairment that patients have to deal with on a daily basis. As such, assessment of health-related quality of life (QoL) is an important aspect of asthma management in clinical practice. Omalizumab (Xolair ® ) is a recombinant humanized monoclonal anti-immunoglobulin E (IgE) antibody that represents a new therapeutic approach to IgE-mediated diseases such as allergi…
Risk of low bone mineral density and low body mass index in patients with non-celiac wheat-sensitivity: a prospective observation study.
2014
Background Non-celiac gluten sensitivity (NCGS) or ‘wheat sensitivity’ (NCWS) is included in the spectrum of gluten-related disorders. No data are available on the prevalence of low bone mass density (BMD) in NCWS. Our study aims to evaluate the prevalence of low BMD in NCWS patients and search for correlations with other clinical characteristics. Methods This prospective observation study included 75 NCWS patients (63 women; median age 36 years) with irritable bowel syndrome (IBS)-like symptoms, 65 IBS and 50 celiac controls. Patients were recruited at two Internal Medicine Departments. Elimination diet and double-blind placebo controlled (DBPC) wheat challenge proved the NCWS diagnosis. A…
Frovatriptan versus almotriptan for acute treatment of menstrual migraine: analysis of a double-blind, randomized, cross-over, multicenter, Italian, …
2012
The objective of the study was to compare the efficacy and safety of frovatriptan and almotriptan in women with menstrually related migraine (IHS Classification of Headache disorders) enrolled in a multicenter, randomized, double-blind, cross-over study. Patients received frovatriptan 2.5 mg or almotriptan 12.5 mg in a randomized sequence: after treating 3 episodes of migraine in no more than 3 months with the first treatment, the patient was switched to the other treatment. 67 of the 96 female patients of the intention-to-treat population of the main study had regular menstrual cycles and were thus included in this subgroup analysis. 77 migraine attacks classified as related to menses were…
Multi-domain impact of elosufase alfa in Morquio A syndrome in the pivotal phase III trial
2015
Objective: To report and discuss the multi-domain impact of elosulfase alfa, with focus on tertiary and composite endpoints, in the 24-week, randomized, double-blind, placebo-controlled phase 3 trial in patients with Morquio A syndrome (mucopolysaccharidosis IVA). Methods: Patients with Morquio A syndrome >= 5 aged years were randomized 1:1:1 to elosulfase alfa 2.0 mg/kg/week (qw; N = 58), elosulfase alfa 2.0 mg/kg/every other week (qow; N = 59), or placebo (N = 59) for 24 weeks. Primary and secondary efficacy measures were 6-minute walk test (6MWT; primary), 3-minute stair climb test (3-MSCT) and urinary keratan sulfate (KS). Safety was also evaluated. Tertiary efficacy measures included r…
Six-month echocardiographic study in patients with submassive pulmonary embolism and right ventricle dysfunction: comparison of thrombolysis with hep…
2010
Abstract Introduction The aim of this study was to assess the effect of thrombolysis versus heparin treatment on echocardiographic parameters and clinical outcome, during hospitalization and within the first 180 days after admission, in patients with first episode of submassive pulmonary embolism (SPE) and right ventricle dysfunction (RVD). Methods Consecutive patients (age, 18–75 years) with a first episode of SPE, symptoms onset since no more than 6 hours, normal blood pressure (> 100 mm Hg), echocardiographic evidence of RVD and positive lung spiral computed tomography were double-blind randomized: 1 group received 100 mg of alteplase (10-mg bolus, followed by a 90-mg intravenous infusio…
Hormonal and psychological factors linked to the increased thermic effect of food in malnourished fasting anorexia nervosa
2007
In patients with anorexia nervosa (AN), weight gain is lower than that expected from the energy content of the meals. Thus we investigated the thermic effect of food (TEF) in relation to subjective feelings and plasma hormone levels in a group of AN patients.TEF, feelings (14 items), and plasma release of beta-endorphin, ACTH, cortisol, dopamine, and catecholamines were evaluated in 15 AN patients (body mass index, 13.6 +/- 1.2 kg.m(-2)) and in 15 healthy women after three gastric loads (0, 300, 700 kcal) infused by a nasogastric tube in a blind design.In AN, the blind loads induced an energy-dependent increase in TEF (P0.001), which was higher than that observed in healthy women (P0.001). …
Prospective Parallel Randomized, Double-Blind, Double-Dummy Controlled Clinical Trial Comparing Clomiphene Citrate and Metformin as the First-Line Tr…
2005
Abstract Context: Although metformin has been shown to be effective in the treatment of anovulation in women with polycystic ovary syndrome (PCOS), clomiphene citrate (CC) is still considered to be the first-line drug to induce ovulation in these patients. Objective: The goal of this study was to compare the effectiveness of metformin and CC administration as a first-line treatment in anovulatory women with PCOS. Design: We describe a prospective parallel randomized, double-blind, double-dummy controlled clinical trial. Setting: The study was conducted at the University “Magna Graecia” of Catanzaro, Catanzaro, Italy. Patients: One hundred nonobese primary infertile anovulatory women with PC…
Food Hypersensitivity as a Cause of Rectal Bleeding in Adults
2008
Background & Aims Rectal bleeding and lymphonodular hyperplasia (LNH) in children can be caused by food hypersensitivity (FH). Our aim was to verify whether similar clinical and endoscopy presentations in adults can be due to FH. Methods Consecutive adult patients with rectal bleeding were enrolled. All underwent routine assays, colonoscopy, and histology study. Results Ten of 64 (15%) patients showed LNH as the unique sign at colonoscopy. An oligoantigenic diet resolved the rectal bleeding in 9 patients, and the reintroduction of several foods caused symptom reappearance. Double-blind placebo-controlled challenges with cow's milk and wheat protein confirmed the FH; symptoms reappeared 1–96…
Diltiazem for Prevention of Acoustical Trauma during Otologic Surgery
1995
100 patients were tested in a prospective, randomized, double-blinded study to assess the perioperative efficacy of a calcium channel blocker (diltiazem) in preventing acoustical trauma during otologic surgery. The patients were randomly divided into a therapy group (diltiazem) and a control group (placebo). Bone conduction hearing thresholds were examined preoperatively and again 1 day and 3 months postoperatively. Frequency-dependent changes in postoperative bone conduction and the number of patients with various degrees of postoperative hearing loss in both groups were statistically analyzed. The results indicated only a small postoperative hearing loss after ear surgery in both groups. …
Cocaine or phenylephrine/lignocaine for nasal fibreoptic intubation?
1996
In order to assess if a mixture of phenylephrine/lignocaine is as effective as cocaine for local analgesia and vasoconstriction during nasal fibreoptic intubation, 99 patients receiving topical nasal analgesia either with cocaine 10% or a mixture of phenylephrine 1% and lignocaine 4% were studied in a randomized double-blind investigation. After topical analgesia a flexible fibreoptic endoscope was advanced through a nostril. Larynx, glottis and trachea were endoscopically sprayed with lignocaine. Following induction of anaesthesia a nasotracheal tube was inserted fibreoptically. Pain intensity and amount of epistaxis during endoscopy were assessed. Blood pressure, heart rate and ECG-ST seg…