Search results for "Single-Blind Method"
showing 10 items of 163 documents
Long-term Immune Response to Hepatitis B Virus Vaccination Regimens in Adults With Human Immunodeficiency Virus 1: Secondary Analysis of a Randomized…
2016
International audience; IMPORTANCE:Data on long-term immune responses to hepatitis B virus (HBV) vaccination in adults with human immunodeficiency virus 1 (HIV-1) infection are scarce.OBJECTIVE:To compare long-term (up to month 42) immune responses to the standard HBV vaccination regimen with a 4-injection intramuscular double-dose regimen and a 4-injection intradermal low-dose regimen.DESIGN, SETTING, AND PARTICIPANTS:The phase 3, open-label, multicenter parallel-group (1:1:1 allocation ratio) randomized clinical trial was conducted from June 28, 2007, to October 23, 2008, at 33 centers in France. Participants included 437 HBV-seronegative adults with HIV-1 and CD4 cell counts of more than…
Effect of chondroitin sulphate on synovitis of knee osteoarthritic patients.
2017
Abstract Objective To evaluate by ultrasonography the effect of chondroitin sulfate (CS) on synovitis in patients with knee osteoarthritis (KOA). To collaborate in the understanding of the biochemical mechanisms involved in the synovial inflammation process. Methods Randomized, single-blind, controlled trial involving 70 patients with primary KOA treated for 6 months with CS or acetaminophen (ACT). Evaluation of KOA status at baseline, 6 weeks, 3 and 6 months included: ultrasonography to assess synovitis (following the OMERACT expertise group definition), visual analogue scale and Lequesne index to measure pain and function, and ELISA to quantify inflammatory mediators in serum and synovial…
Changes in fruit and vegetable consumption habits from pre-pregnancy to early pregnancy among Norwegian women
2017
Background: A healthy diet is important for pregnancy outcome and the current and future health of woman and child. The aims of the study were to explore the changes from pre-pregnancy to early pregnancy in consumption of fruits and vegetables (FV), and to describe associations with maternal educational level, body mass index (BMI) and age. Methods: Healthy nulliparous women were included in the Norwegian Fit for Delivery (NFFD) trial from September 2009 to February 2013, recruited from eight antenatal clinics in southern Norway. At inclusion, in median gestational week 15 (range 9–20), 575 participants answered a food frequency questionnaire (FFQ) where they reported consumption of FV, bot…
The F4/AS01B HIV-1 Vaccine Candidate Is Safe and Immunogenic, But Does Not Show Viral Efficacy in Antiretroviral Therapy-Naive, HIV-1-Infected Adults…
2016
Supplemental Digital Content is available in the text
An Internet-based treatment for flying phobia (NO-FEAR Airlines): study protocol for a randomized controlled trial
2016
Background: Flying phobia (FP) is a common and disabling mental disorder. Although in vivo exposure is the treatment of choice, it is linked to a number of limitations in its implementation. Particularly important, is the limited access to the feared stimulus (i.e., plane). Moreover, the economic cost of in vivo exposure should be specially considered as well as the difficulty of applying the exposure technique in an appropriate way; controlling important variables such as the duration of the exposure or the number of sessions. ICTs could help to reduce these limitations. Computer-assisted treatments have remarkable advantages in treating FP. Furthermore, they can be delivered through the I…
Effects of clopidogrel, prasugrel and ticagrelor on endothelial function, inflammatory and oxidative stress parameters and platelet function in patie…
2014
Introduction Particularly in the setting of acute coronary syndromes, the interplay between vascular and platelet function has been postulated to have direct clinical implications. The present trial is designed to test the effect of clopidogrel, prasugrel and ticagrelor on multiple parameters of vascular function, platelet aggregation, oxidative and inflammatory stress before and up to 4 weeks after coronary artery stenting. Methods and analysis The study is designed as a three-arm, parallel design, randomised, investigator-blinded study. Patients with unstable angina or non-ST elevation myocardial infarction undergoing coronary intervention with a drug-eluting stent will be randomised to r…
Comparison of combined application treatment with one-visit varnish treatments in an orthodontic population
2013
Objective: To evaluate the effect of chlorhexidine-thymol varnish alone, its combination with chlorhexidine-fluo - ride containing dentifrice and fluoride varnish on oral hygiene and caries prevention in orthodontic patients. Study design: Sixty patients, aged 12-18, with orthodontic fixed appliances were randomly assigned into three groups as follows: Group 1 (n=20): 1% chlorhexidine and 1% thymol varnish (Cervitec ® Plus); Group 2 (n=20): Cervitec ® Plus+ 0.2% chlorhexidine and 0.2% sodium fluoride (900 ppm fluoride) (Cervitec ® Gel)); and Group 3 (n=20): 0.1% fluoride varnish (Fluor Protector ® ). Mutans streptococci (MS), lactobacilli (LB) levels, buffering capacity (BC), visible plaque…
A combined treatment regimen for chronic desquamative gingivitis in patients with oral lichen planus
2007
Background: Chronic desquamative gingivitis (DG) is a condition characterized by erythema, ulceration, and desquamation of the free and attached gingiva, usually expression of a district-systemic disease, such as oral lichen planus (OLP). Methods: A combined protocol of oral hygiene and topic corticosteroid therapy was applied in 30 patients with DG associated with OLP. Plaque index (PI) and bleeding on probing (BoP) were evaluated at baseline and after 3 months. Results: PI scoring was significantly lower after treatment in anterior, posterior, and all sites (P < 0.0001) as well as in vestibular and lingual ones (P < 0.0001 and P = 0.0001, respectively). BoP measures were found to be reduc…
Acute effects on the human EEG after an external exposure to 200 ppm methanol
2001
Objectives: Even low concentrations of organic solvents may cause acute effects on the human central nervous system. The German MAK (threshold limit value) of methanol is 200 ppm. The aim of this study was to investigate whether acute exposure to 200 ppm methanol causes adverse effects, measured by EEG, and moreover, whether it is possible to differentiate between sedative and excitatory effects with this method. Methods: Twelve healthy subjects were exposed for 4 h to 200 ppm and to 20 ppm (control) in an exposure chamber in a cross-over design. The EEG was recorded before (reference) and at the end of each exposure with, the subject's eyes closed and opened and during a choice reaction te…
Randomised controlled trial of montelukast plus inhaled budesonide versus double dose inhaled budesonide in adult patients with asthma
2003
Background: Inhaled corticosteroids (ICS) affect many inflammatory pathways in asthma but have little impact on cysteinyl leukotrienes. This may partly explain persistent airway inflammation during chronic ICS treatment and failure to achieve adequate asthma control in some patients. This double blind, randomised, parallel group, non-inferiority, multicentre 16 week study compared the clinical benefits of adding montelukast to budesonide with doubling the budesonide dose in adults with asthma. Methods: After a 1 month single blind run in period, patients inadequately controlled on inhaled budesonide (800 µg/day) were randomised to receive montelukast 10 mg + inhaled budesonide 800 µg/day (n…