Search results for "double-blind"
showing 10 items of 662 documents
Soft tissue cell adhesion to titanium abutments after different cleaning procedures: preliminary results of a randomized clinical trial
2013
Objectives: A randomized controlled trial was performed to assess soft tissue cell adhesion to implant titanium abutments subjected to different cleaning procedures and test if plasma cleaning can enhance cell adhesion at an early healing time. Study Design: Eighteen patients with osseointegrated and submerged implants were included. Before re-opening, 18 abutments were divided in 3 groups corresponding to different clinical conditions with different cleaning processes: no treatment (G1), laboratory customization and cleaning by steam (G2), cleaning by plasma of Argon (G3). Abutments were removed after 1 week and scanning electron microscopy was used to analyze cell adhesion to the abutment…
Effects of yohimbine on sexual experiences and nocturnal penile tumescence and rigidity in erectile dysfunction.
1996
The therapeutic effect of the alpha 2-antagonist yohimbine in erectile dysfunction was studied in a double-blind placebo-controlled design. Thirty-one male patients underwent extensive clinical, urological, and psychiatric diagnosis and were dichotomically classified into an organic and a nonorganic subgroup. Following a 1-week placebo run-in period, patients were randomly assigned to a placebo or a verum group (yohimbine 15 mg daily) for a treatment period of 7 weeks. The Clinical Global Impression (CGI) scale was used as the primary efficacy parameter. Additionally, nocturnal penile tumescence and rigidity (NPTR) were measured. Global assessment of erectile function applying the CGI scale…
Posaconazole or Fluconazole for Prophylaxis in Severe Graft-versus-Host Disease
2007
Invasive fungal infections are an important cause of morbidity and mortality after allogeneic hematopoietic stem-cell transplantation.In an international, randomized, double-blind trial, we compared oral posaconazole with oral fluconazole for prophylaxis against invasive fungal infections in patients with graft-versus-host disease (GVHD) who were receiving immunosuppressive therapy. The primary end point was the incidence of proven or probable invasive fungal infections from randomization to day 112 of the fixed treatment period of the study.Of a total of 600 patients, 301 were assigned to posaconazole and 299 to fluconazole. At the end of the fixed 112-day treatment period, posaconazole wa…
Reslizumab for inadequately controlled asthma with elevated blood eosinophil counts: results from two multicentre, parallel, double-blind, randomised…
2015
Elevated numbers of blood eosinophils are a risk factor for asthma exacerbations. Reslizumab is a humanised anti-interleukin 5 monoclonal antibody that disrupts eosinophil maturation and promotes programmed cell death. We aimed to assess the efficacy and safety of reslizumab in patients with inadequately controlled, moderate-to-severe asthma.We did two duplicate, multicentre, double-blind, parallel-group, randomised, placebo-controlled phase 3 trials. Both trials enrolled patients with asthma aged 12-75 years (from 128 clinical research centres in study 1 and 104 centres in study 2) from Asia, Australia, North America, South America, South Africa, and Europe, whose asthma was inadequately c…
Tiotropium Respimat® in asthma: a double-blind, randomised, dose-ranging study in adult patients with moderate asthma
2013
Tiotropium, a once-daily long-acting anticholinergic bronchodilator, when administered via Respimat® SoftMist™ inhaler (tiotropium Respimat®) significantly reduces the risk of severe exacerbations and improves lung function in patients with severe persistent asthma that is not fully controlled despite using inhaled corticosteroids (ICS) and long-acting β2-agonists. To further explore the dose–response curve in asthma, we investigated the efficacy and safety of three different doses of tiotropium Respimat® as add-on to ICS in symptomatic patients with moderate persistent asthma. In this randomised, double-blind, placebo-controlled, four-way crossover study, patients were randomised to tiotro…
Effect of Salmeterol on Seasonal Changes in Airway Responsiveness and Exhaled Nitric Oxide in Pollen-Sensitive Asthmatic Subjects
2002
Objective Using a model of natural allergen exposure, we examined the effect of regular treatment with salmeterol on allergen-induced changes in airway responsiveness and exhaled nitric oxide (ENO). Design Double-blind, randomized, parallel-group study. Setting Specialist allergy unit in a university hospital. Patients Asthmatic patients sensitized to pollen allergens were randomly allocated to monotherapy with salmeterol (n = 14) or placebo (n = 13). Interventions Salmeterol, 25 μg, and placebo inhalers, two puffs bid, for 6 weeks. Measurements Spirometry, the level of a provocative concentration of a substance (methacholine) causing a 20% fall in FEV 1 (PC 20 ), the PC 20 level for adenos…
Effect of QVA149 on lung volumes and exercise tolerance in COPD patients: The BRIGHT study
2014
Summary Introduction QVA149 is a novel, inhaled, once-daily dual bronchodilator containing a fixed-dose combination of the long-acting β 2 -agonist indacaterol and the long-acting muscarinic antagonist glycopyrronium (NVA237), for the treatment of chronic obstructive pulmonary disease (COPD). This study evaluated the effects of QVA149 on exercise tolerance, hyperinflation, lung function and lung volumes versus placebo and tiotropium. Methods Patients with moderate-to-severe COPD were randomized to QVA149 110/50 μg, placebo or tiotropium 18 μg once daily in a blinded, 3-period crossover study for 3 weeks. The primary endpoint was exercise endurance time at Day 21 for QVA149 versus placebo. R…
A randomized, double-blind study to compare the efficacy and safety of two doses of mometasone furoate delivered via Breezhaler® or Twisthaler® in pa…
2019
Abstract Introduction Mometasone furoate (MF) is the inhaled corticosteroid (ICS) component in the long-acting β2-agonist (LABA)/ICS fixed-dose combination of indacaterol/MF, delivered via Breezhaler®, in development for asthma. MF at low (80 μg) and high (320 μg) doses delivered via Breezhaler® is expected to be comparable to MF at low (200 μg) and high (800 μg) doses respectively, delivered via Twisthaler®. Methods This was a randomized, double-blind, double-dummy, four-week, parallel-group study of 739 adolescents and adults with persistent asthma. Eligible patients were receiving ICS treatment up to the maximum dose per day on a stable regimen for at least four weeks before screening. T…
Analysis of sleep EEG microstructure in subchronic paroxetine treatment of healthy subjects
1997
Paroxetine is a selective and potent serotonin reuptake inhibitor and its efficacy for the treatment of depression has been proven. Under acute and subchronical treatment regimens, disturbances of the regular sleep pattern are a reported side effect of the drug. The present study was therefore performed to investigate the impact of subchronic treatment with the selective serotonin reuptake inhibitor paroxetine on the microstructure of the sleep EEG. The study especially addressed the question of subchronic effects of paroxetine medication (30 mg/day) in eight healthy male volunteers in a double blind, placebo-controlled crossover design. Conventional sleep EEG parameters and a spectral powe…
Serotonergic modulation of response inhibition and re-engagement? Results of a study in healthy human volunteers
2010
Objective Cognitive functions dependent on the prefrontal cortex, such as the ability to suppress behavior (response inhibition) and initiate a new one (response re-engagement) is important in the activities of daily life. Central serotonin (5-HT) function is thought to be a critical component of these cognitive functions. In recent studies, 5-HT failed to affect stop-signal reaction time (SSRT), a fundamental process in behavioral inhibition. We were interested if response inhibition and re-engagement are influenced through central 5-HT activity as mediated via the 5-HT transporter. Methods Here, using a stop-change task, we investigated the effects of acute and repeated treatment with 10 …