Search results for "double"
showing 10 items of 2879 documents
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…
Subepithelial connective tissue graft with or without enamel matrix derivative for the treatment of Miller class I and II gingival recessions: a cont…
2012
Background The aim of this study was to evaluate whether the combination of enamel matrix derivative (EMD) with subepithelial connective tissue graft (SCTG) plus coronally advanced flap (CAF) would improve the treatment outcomes of Miller class I and II gingival recessions when compared with the same technique (SCTG plus CAF) alone. Methods The study was designed as a randomized, parallel, controlled, double-blinded clinical trial. Forty-two patients were randomly assigned in the test group (SCTG plus EMD) and in the control group (SCTG). Patients had at least one gingival recession ≥ 2 mm. The clinical parameters were evaluated at baseline and at 14 d, 1, 3, 6 and 12 mo follow-up time poin…
A multicenter, double-blind, randomized, placebo-controlled trial of the β3-adrenoceptor agonist solabegron for overactive bladder
2012
Abstract Background β-Adrenoceptor agonists are effective in animal models of bladder dysfunction, and the human bladder primarily expresses the β3 receptor subtype. Objective To evaluate the efficacy and tolerability of the highly selective and potent β3-adrenoceptor agonist solabegron in a clinical proof-of-concept study in incontinent women with overactive bladder (OAB). Design, setting, and participants This was a randomized, double-blind trial in adult women with OAB (one or more 24-h incontinence episodes and eight or more average 24-h micturitions). Interventions Solabegron 50mg ( n =88), solabegron 125mg ( n =85), or placebo ( n =85)—all twice daily—were administered. Outcome measur…
Ulipristal acetate versus leuprolide acetate for uterine fibroids
2012
A b s t r ac t Background The efficacy and side-effect profile of ulipristal acetate as compared with those of leuprolide acetate for the treatment of symptomatic uterine fibroids before surgery are unclear. Methods In this double-blind noninferiority trial, we randomly assigned 307 patients with symptomatic fibroids and excessive uterine bleeding to receive 3 months of daily therapy with oral ulipristal acetate (at a dose of either 5 mg or 10 mg) or once-monthly intramuscular injections of leuprolide acetate (at a dose of 3.75 mg). The primary outcome was the proportion of patients with controlled bleeding at week 13, with a prespecified noninferiority margin of −20%. Results Uterine bleed…