Search results for "Double blind"
showing 10 items of 81 documents
THU0349 A Double-Blind, Randomised, Parallel Group, Active Controlled, Multicentre Study to Assess the Therapeutic Non-Inferiority of Skp-021, A 0.3%…
2014
Background NSAIDs are the first choice for management of acute musculoskeletal pain. Acute musculoskeletal pain is often associated with trauma, surgery, musculoskeletal injuries like strains, sprains and over-use injuries Objectives The primary study endpoint was the estimate of the non-inferiority of the Test drug (Ketoprofen) vs. the Reference drug (Diclofenac). This was performed by assessment of the proportion of responders (response: 50% or more reduction of baseline VAS % (95%CI) at the end of treatment) in the two treatment groups. Methods This phase III, randomised, blinded, active-control and non-inferiority study involved 697 adults with acute muskuloskeletal pain. Participants w…
Anti-cytokine therapy for prevention of atherosclerosis
2015
Abstract Background Currently a chronic inflammation is considered to be the one of the most important reasons of the atherosclerosis progression. A huge amount of researches over the past few decades are devoted to study the various mechanisms of inflammation in the development of atherosclerotic lesions. Purpose To review current capabilities of anti-inflammatory therapy for the prevention and treatment of atherosclerosis and its clinical manifestations. Methods Appropriate articles on inflammatory cytokines in atherosclerosis and anti-inflammatory prevention of atherosclerosis were searched in PubMed Database from their respective inceptions until October 2015. Sections “The role of infl…
Randomised double-blind clinical trial of intermediate- versus high-dose chloral hydrate for neuroimaging of children.
1995
Orally administered chloral hydrate is the most widely used sedative in children undergoing MRI. We compared intermediate- and high-dose oral chloral hydrate in 97 consecutive children undergoing MRI in a prospective, controlled, double-blind, randomised clinical trial. There were 50 girls and 47 boys, mean weight (+/- SD) 14.7 +/- 6.4 kg, and mean age 38 +/- 31. The children were randomly allocated to receive chloral hydrate syrup either 70 mg/kg (group A, n = 50) or 100 mg/kg (group B, n = 47). These two groups were not significantly different in sex, weight, age, diagnosis or ambulatory medication. The mean initial dose (+/- SEM) was 64 +/- 2 mg/kg for group A and 93 +/- 2 mg/kg for grou…
Erythropoietin in amyotrophic lateral sclerosis: a multicentre, randomized, double blind, placebo controlled, phase III study.
2015
Objective To assess the efficacy of recombinant human erythropoietin (rhEPO) in amyotrophic lateral sclerosis (ALS). Methods Patients with probable laboratory-supported, probable or definite ALS were enrolled by 25 Italian centres and randomly assigned (1:1) to receive intravenous rhEPO 40 000 IU or placebo fortnightly as add-on treatment to riluzole 100 mg daily for 12 months. The primary composite outcome was survival, tracheotomy or >23 h non-invasive ventilation (NIV). Secondary outcomes were ALSFRS-R, slow vital capacity (sVC) and quality of life (ALSAQ-40) decline. Tolerability was evaluated analysing adverse events (AEs) causing withdrawal. The randomisation sequence was computer-…
An evaluation of the efficacy of a topical gel with Triester Glycerol Oxide (TGO) in the treatment of minor recurrent aphthous stomatitis in a Turkis…
2017
Background Triester glycerol oxide gel (Protefix® Queisser Pharma, Germany) is a new topical agent that has the property of adherence to the oral mucosa by forming a lipid film which protects against mechanical trauma and may help to reduce oral tissue moisture loss and inflammation. The aim of this clinical trial was to determine the efficacy of a topical TGO gel and to also compare it with triamcinolone acetonide pomade in the treatment of minor recurrent aphthous stomatitis. Material and Methods This study was a randomized, double-blind, placebo-controlled clinical trial and 180 patients with the complaint of minor aphthous ulcers were enrolled in this study. The sociodemographic data an…
Efficacy and tolerability of EH301 for amyotrophic lateral sclerosis: a randomized, double-blind, placebo-controlled human pilot study
2019
Background: Amyotrophic lateral sclerosis (ALS) is a devastating neurodegenerative disease, characterized by progressive loss of spinal and cortical motor neurons, leading to muscular atrophy, respiratory failure, and ultimately death. There is no known cure, and the clinical benefit of the two drugs approved to treat ALS remains unclear. Novel disease-modifying therapeutics that are able to modulate the disease course are desperately needed. Our objective was to evaluate the efficacy and tolerability of Elysium Health's candidate drug EH301 in people with ALS (PALS). Methods: This was a single-center, prospective, double-blind, randomized, placebo-controlled pilot study. Thirty-two PALS we…
Randomized double-blind placebo-controlled trial of acetyl-L-carnitine for ALS.
2013
Our objective was to assess the effects of acetyl-L-carnitine (ALC) with riluzole on disability and mortality of amyotrophic lateral sclerosis (ALS). Definite/probable ALS patients, 40-70 years of age, duration 6-24 months, self-sufficient (i.e. able to swallow, cut food/handle utensils, and walk), and with forced vital capacity (FVC) > 80% entered a pilot double-blind, placebo-controlled, parallel group trial and were followed for 48 weeks. ALC or placebo 3 g/day was added to riluzole 100 mg/day. Primary endpoint: number of patients no longer self-sufficient. Secondary endpoints: changes in ALSFRS-R, MRC, FVC and McGill Quality of Life (QoL) scores. Analysis was made in the intention-to-tr…
Double-blind, crossover study of the clinical efficacy and the hemorheological effects of pentoxifylline in patients with occlusive arterial disease …
1984
The effect of a 3 month daily administration of 800 mg pentoxifylline (Trental 400 bds) or placebo was assessed under double blind crossover design in 18 patients (12 males and 6 females) with peripheral occlusive arterial disease in respect of painfree walking distance and various hemorheological and hemostasiological variables, platelet aggregation, serum cholesterol and triglycerides. In first treatment period walking distance significantly increased with pentoxifylline by 46% from baseline 121 ± 15 m and by 4% with placebo from baseline 134 ± 18 m. Pentoxifylline administration furthermore yielded significant decrease in whole blood and plasma viscosity and significant increase in eryt…
Turning Kurt Lewin on his head: Nothing is so theoretical as a good practice
2016
Abstract Kurt Lewin is acknowledged as the “father of social change theories” because his work has affected many models. Inspired by Lewin's massive contribution to science, this special issue of Journal of Business Research (JBR) collects papers regarding “Turning Kurt Lewin on his head: Nothing is so theoretical as a good practice.” These papers are presented in the 6th Conference of the Global Innovation and Knowledge Academy (GIKA 2016), in Valencia, Spain, from March 20 to March 23. After double blind reviews, only 75 papers are recommended to this special issue.
Postoperative effects on lower third molars of using mouthwashes with super-oxidized solution versus 0.2% chlorhexidine gel : a randomized double-bli…
2018
Background The main objective of the present study is to evaluate the effects and possible benefits with regard to the postoperative period of lower third molar extractions, comparing the intraalveolar application of a bioadhesive gel of 0.2% chlorhexidine (CHX) to the use of a mouthwash with a super-oxidized solution, (SOS) Dermacyn® Wound Care (Oculus Innovative Sciences lnc., California, USA). Material and Methods A randomized double-blind study was carried out in 20 patients with a split-mouth design, with a total of 40 extractions of symmetrically impacted bilateral lower third molars. Patients were divided into two groups, a control group (C = 20) and an experimental group (D = 20). A…