Search results for "double-blind method"

Effects of ipriflavone on bone mass and calcium metabolism in postmenopausal osteoporosis.

1992

Recently it has been demonstrated that ipriflavone (IP), an isoflavone derivative, is able to increase bone mass in patients with established postmenopausal osteoporosis (PMO). Here we present a preliminary report of a 2-year multicenter, double-blind, placebo-controlled clinical study performed in order to evaluate the efficacy and tolerability of IP in PMO. A large number of patients with PMO, referred to 12 Italian centers, was randomly divided into 2 groups and treated with oral IP (600 mg/day) or placebo (Pl). All patients received an oral Ca supplement (1 g/day). One hundred and twenty six patients completed 1 year of the study. Bone mineral density (BMD) of the distal radius, measure…

Impact of the pupil size – central optical zone diameter relationship on visual performance in aspheric multifocal contact lenses

2020

Abstract Purpose To determine the impact of different central optical zone diameters (COZDs), obtained from pupil size, on the visual performance of presbyopic subjects fitted with centre-distance simultaneous-image multifocal contact lenses (SIMCLs). Methods Thirty-two presbyopic volunteers, between 45–58 years of age, participated in this prospective, controlled, double-blind study. Subjects were fitted with 5 centre-distance SIMCLs of variable COZD, determined from the measurement of pupil size under photopic light conditions and corresponding to 60, 70, 80, 90 and 100 % of pupil diameter. Subjects visual performance was evaluated through the measurement of distance, intermediate and nea…

Metastatic Versus Osteoporotic Vertebral Fractures on MRI: A Blinded, Multicenter, and Multispecialty Observer Agreement Evaluation.

2020

Background: MRI is assumed to be valid for distinguishing metastatic vertebral fractures (MVFs) from osteoporotic vertebral fractures (OVFs). This study assessed (1) concordance between the image-based diagnosis of MVF versus OVF and the reference (biopsy or follow-up of >6 months), (2) interobserver and intraobserver agreement on key imaging findings and the diagnosis of MVF versus OVF, and (3) whether disclosing a patient’s history of cancer leads to variations in diagnosis, concordance, or agreement. Patients and Methods: This retrospective cohort study included clinical data and imaging from 203 patients with confirmed MVF or OVF provided to 25 clinicians (neurosurgeons, radiologists…

Methodological matters on an Alzheimer's dementia trial: is a double-blind randomized controlled study design sufficient to draw strong conclusions o…

2007

Inhaled amikacin versus placebo to prevent ventilator-associated pneumonia: the AMIKINHAL double-blind multicentre randomised controlled trial protoc…

2021

IntroductionPre-emptive inhaled antibiotics may be effective to reduce the occurrence of ventilator-associated pneumonia among critically ill patients. Meta-analysis of small sample size trials showed a favourable signal. Inhaled antibiotics are associated with a reduced emergence of antibiotic resistant bacteria. The aim of this trial is to evaluate the benefit of a 3-day course of inhaled antibiotics among patients undergoing invasive mechanical ventilation for more than 3 days on the occurrence of ventilator-associated pneumonia.Methods and analysisAcademic, investigator-initiated, parallel two group arms, double-blind, multicentre superiority randomised controlled trial. Patients invasi…

Transdermal nitroglycerine treatment of shoulder tendinopathies in patients with spinal cord injuries.

2011

A clinical blind study was conducted to determine the efficacy of transdermal nitroglycerine treatment on the awareness of shoulder pain. This study aims to determine the effects of transdermal nitroglycerine on shoulder pain and on functional shoulder movement in patients with spinal cord injuries and shoulder tendinopathies. A second aim is to establish the side effects of the treatment. Hospital “La Fe” in Valencia, Spain. A total of 45 spinal cord injury patients, all of whom are wheelchair users with shoulder tendinopathy, were randomly divided into two groups: placebo (n=12) and experimental (n=33). The experimental group (EG) received transdermal treatment for 6 months in the form of…

Immunogenicity and safety of a quadrivalent high-dose inactivated influenza vaccine compared with a standard-dose quadrivalent influenza vaccine in h…

2021

A quadrivalent high-dose inactivated influenza vaccine (IIV4-HD) is licensed for adults ≥65 y of age based on immunogenicity and efficacy studies. However, IIV4-HD has not been evaluated in adults aged 60–64 y. This study compared immunogenicity and safety of IIV4-HD with a standard-dose quadrivalent influenza vaccine (IIV4-SD) in adults aged ≥60 y. This Phase III, randomized, modified double-blind, active-controlled study enrolled 1,528 participants aged ≥60 y, randomized 1:1 to a single injection of IIV4-HD or IIV4-SD. Hemagglutination inhibition (HAI) geometric mean titers (GMTs) were measured at baseline and D 28 and seroconversion assessed. Safety was described for 180 d after vaccinat…

Serenoa repens, lycopene and selenium versus tamsulosin for the treatment of LUTS/BPH. An Italian multicenter double-blinded randomized study between…

2014

Absence of Adverse Effects of Tiotropium/Olodaterol Compared with the Monocomponents on Long-Term Heart Rate and Blood Pressure in Patients with Mode…

2020

Stefan Andreas,1,2 Lorcan McGarvey,3 Ulrich Bothner,4 Matthias Trampisch,4 Alberto de la Hoz,4 Matjaz Fležar,5 Roland Buhl,6 Peter Alter7 1Department of Cardiology and Pneumology, University Medical Center Göttingen, Göttingen, Germany; 2LungClinic Immenhausen, Immenhausen, Germany, Member of the German Center for Lung Research (DZL); 3Queen’s University Belfast, Belfast, UK; 4Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany; 5Klinika Golnik, Golnik, Slovenia; 6Pulmonary Department, Johannes Gutenberg University Mainz, Mainz, Germany; 7Department of Medicine, Pulmonary and Critical Care Medicine, Philipps University of Marburg (UMR); Member o…

Effect of RNS60 in amyotrophic lateral sclerosis: a phase II multicentre, randomized, double-blind, placebo-controlled trial

2022

Background and purpose: Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease with limited treatment options. RNS60 is an immunomodulatory and neuroprotective investigational product that has shown efficacy in animal models of ALS and other neurodegenerative diseases. Its administration has been safe and well tolerated in ALS subjects in previous early phase trials. Methods: This was a phase II, multicentre, randomized, double-blind, placebo-controlled, parallel-group trial. Participants diagnosed with definite, probable or probable laboratory-supported ALS were assigned to receive RNS60 or placebo administered for 24 weeks intravenously (375 ml) once a week and via nebul…