Search results for "PLACEBO"
showing 10 items of 704 documents
Efficacy and safety of open-label caplacizumab in patients with exacerbations of acquired thrombotic thrombocytopenic purpura in the HERCULES study.
2020
BACKGROUND Acquired thrombotic thrombocytopenic purpura (aTTP) is a rare, life-threatening autoimmune thrombotic microangiopathy. Caplacizumab, an anti-von Willebrand Factor Nanobody® , is effective for treating aTTP episodes and is well tolerated. OBJECTIVES AND METHODS In the phase 3 HERCULES trial (NCT02553317), patients with aTTP received double-blind caplacizumab or placebo during daily therapeutic plasma exchange (TPE) and for ≥30 days thereafter. Patients who experienced an exacerbation while on blinded study drug treatment switched to receive open-label caplacizumab plus re-initiation of daily TPE. Exacerbations were defined as recurrence of disease occurring within 30 days after ce…
Late Breaking Abstract - Efficacy of CSJ117 on allergen-induced asthmatic responses in mild atopic asthma patients
2020
Introduction: CSJ117 is a potent neutralizing antibody fragment against human Thymic stromal lymphopoietin (TSLP), formulated as a PulmoSol™ engineered powder in hard capsules for delivery to the lungs via dry powder inhaler. Methods: In this double-blind, placebo-controlled study, 28 mild, atopic asthmatics meeting elibility criteria were randomized to receive 4mg CSJ117 (n = 15) or placebo (n = 13) inhaled daily for 12 weeks. Allergen inhalation challenge (AIC) was conducted at screening, day 42 and day 84. The primary efficacy variable was the late asthmatic response (LAR), measured 3 to 7 hours after AIC at day 84. Other outcomes included the early asthmatic response (EAR) measured with…
A decade of trials of interferon-alpha for chronic hepatitis C. A meta-regression analysis
2003
The most relevant randomized controlled trials of interferon-alpha (IFN) for naive patients with chronic hepatitis C (CHC) published in a decade, just before appearance of pegylated IFN trials in 2000, were included in this paper. Its purpose is to review the relationship between sustained biochemical response in active versus control group versus usual clinical variables as IFN regimens, cirrhosis, genotype and versus less frequently addressed variables as funding, methodological quality or location of principal author. Meta-analysis estimates of global treatment effect varied according to trial design: group 1=IFN versus placebo/no treatment, 32 RCTs, 2499 pts, OR 9.5 (6.3-14.2); group 2a…
The effects of transdermal testosterone and oestrogen therapy on dry eye in postmenopausal women: a randomised, placebo-controlled, pilot study
2016
Aims Sex hormones could provide a future treatment avenue for dry eye post menopause. However, there are few well-controlled studies. This study investigates the impact of testosterone and oestrogen on dry eye symptoms and signs in postmenopausal women. Methods A randomised double-blind placebo-controlled pilot study was conducted involving 40 women with dry eye (age 63.9±5.1 years, 13.2±6.3 years post menopause). Ten women were assigned to each of four treatment groups: transdermal testosterone, oestradiol, testosterone/oestradiol combination and placebo. Assessment at baseline and after 8 weeks: ocular symptoms, tear osmolarity, tear stability, tear secretion, meibomian gland assessment, …
Efficacy of botulinum toxin in the treatment of bruxism : systematic review
2019
Background Currently it has been shown that botulinum toxin is effective for a wide variety of medical conditions, and can be applied for therapeutic purposes as cosmetic. In recent years, there has been a growing trend in the use of this drug substance to control the muscular overactivity of bruxism. The objective of this study was the use of botulinum toxin type A (BTX-A) than traditional methods, by conducting a systematic review of randomized clinical trials (RCTs) published in the health sciences literature. Material and Methods An electronic search was made in the databases of the PubMed, Cochrane Library and Scopus data between March and October 2017, ECA, which will analyze the effe…
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…
Sustained safety and efficacy of ligelizumab in patients with chronic spontaneous urticaria: A one‐year extension study
2021
Background: Ligelizumab, a next-generation, humanized anti-immunoglobulin E (IgE) monoclonal antibody is in development as a treatment for patients with chronic spontaneous urticaria, whose symptoms are inadequately controlled with standard-of-care therapy. Objective: To evaluate the long-term safety and re-treatment efficacy of ligelizumab 240 mg in patients who completed the core study and extension study. Methods: This open-label, single-arm, long-term Phase 2b extension study was designed to assess patients who were previously administered various doses of ligelizumab, omalizumab or placebo in the Phase 2b, dose-finding core study and who presented with active disease after Week 32. In …
Efficacy of the photobiomodulation therapy in the treatment of the burning mouth syndrome
2019
Background This study aims to evaluate the efficacy of the photobiomodulation therapy (PBMT) - in terms of pain and of quality of life- in patients affected by burning mouth syndrome (BMS). Material and Methods This study was designed as a randomised double-blinded prospective study. Patients diagnosed with BMS in the period from June 2015 to June 2018 were recruited. The patients were randomised into two groups and each received treatment once a week for ten weeks: group A received laser therapy (K Laser Cube 3®) while group B was given sham therapy (placebo). Pain was evaluated through the Visual Analogue Scale (VAS) and quality of life was assessed with the short form of the Oral Health …
Photobiomodulation therapy for the management of recurrent aphthous stomatitis in children : clinical effectiveness and parental satisfaction
2020
Background This study aims to evaluate the effectiveness of the photobiomodulation therapy (PBMT) in the treatment of minor recurrent aphthous stomatitis (MiRAS) in children, in terms of pain relief, lesion size reduction and the parental satisfaction of the therapy. Material and Methods This randomized controlled study was carried out on 60 children with clinical diagnosis of MiRAS. Patients were randomized into two groups: group A receiving laser therapy and group B receiving sham therapy (placebo). Laser therapy (diode laser, λ: 645 nm) was administered on day 1 (T0) for three consecutive days. Patients were evaluated also on day 4 (T1), on day 7 (T2) and on day 10 (T3). Oral aphthous le…
Local Formula with Mucoadhesive Property: A Randomized Clinical Trial of a Therapeutic Agent for the Treatment of Oral Aphthous Ulcers
2020
Background Recurrent or occasional aphthous lesions represent a painful oral condition with high prevalence. Since the etiology is still unclear and most likely related to a dysfunction in the local immune system, several treatment strategies have been proposed, including systemic agents, local agents, and laser therapy, to reduce the pain and discomfort for the patient without acting on the causes. Materials and methods The purpose of the present randomized study was to assess the clinical efficacy of a new topical gel with mucoadhesive property to reduce the pain and the dimension of the aphthosis lesions. Fifty patients presenting at least one minor ulcer were randomized to a control gro…