Search results for "double blind"

Suspected Nonceliac Gluten Sensitivity Confirmed in Few Patients After Gluten Challenge in Double-Blind, Placebo-Controlled Trials

2017

A double-blind, placebo-controlled, gluten challenge has been proposed to confirm a diagnosis of non-celiac gluten sensitivity (NCGS) in patients without celiac disease who respond to a gluten-free diet. To determine the accuracy of this approach, we analyzed data from 10 double-blind, placebo-controlled, gluten challenge trials, comprising 1312 adults. The studies varied in the duration of the challenge (ranging from 1 day to 6 weeks), daily doses for the gluten challenge (ranging from 2 g to 52 g; 3 studies administered less than 8 g/day), and composition of the placebo (gluten-free products, xylose, whey protein, rice, or corn starch containing fermentable carbohydrates). Most of the stu…

EPA-0666 – Long-term maintenance of efficacy of extended-release guanfacine hydrochloride (GXR) in children and adolescents with attention-deficit/hy…

2014

Introduction GXR, a selective α2A-adrenergic agonist, is a non-stimulant ADHD treatment approved in the USA for children and adolescents, and in Canada for children. Objectives To evaluate long-term maintenance of efficacy of GXR in children and adolescents with ADHD who respond to an initial open-label, short-term trial. Aims To determine if there is a higher rate of treatment failure for placebo vs GXR during the double-blind randomised-withdrawal phase (RWP) (NCT01081145). Methods Patients (6–17 years) meeting DSM-IV-TR criteria for ADHD, baseline ADHD Rating Scale-IV (ADHD-RS-IV) ≥32 and Clinical Global Impressions-Severity (CGI-S) ratings ≥4 were enrolled. Following 7-week dose optimiz…

Effectiveness of amlexanox and adcortyl for the treatment of recurrent aphthous ulcers

2015

Background Recurrent aphthous stomatitis (RAS) is a common condition that affects approximately 20% of the general population. The ulcers can interfere with speech and eating and cause significant pain and discomfort. This study aimed to evaluate the efficacy of Amlexanox and Adcortyl in the treatment of aphthous ulcers. Material and Methods In this randomized double blind clinical trial with sequential patient entry, a total of 40 patients who presented with aphthous ulcers were included. Patients were received Amlexanox or Adcortyl four times daily for 7 days. Patients were evaluated for pain, lesion size, and tingling at one day, three days, five days and seven days follow-ups. The treat…

Effect of genetic polymorphisms involved in folate metabolism on the concentration of serum folate and plasma total homocysteine (p-tHcy) in healthy …

2015

Data on the effect of combined genetic polymorphisms, involved in folate metabolism, on the concentration of serum folate after folic acid supplementation are scarce. Therefore, we investigated the impact of seven gene polymorphisms on the concentration of serum folate and p-tHcy in healthy subjects after short-term folic acid supplementation. In a randomized, double blind, crossover study, apparently healthy subjects were given either 0.8 mg folic acid per day (n = 46) or placebo (n = 45) for 14 days. The washout period was 14 days. Fasting blood samples were collected on day 1, 15, 30 and 45. Data on subjects on folic acid supplementation (n = 91) and on placebo (n = 45) were used for the…

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

2007

P-34 The randomized, double-blind, placebo-controlled phase 3 trial KEYNOTE-975: Pembrolizumab vs placebo in patients with esophageal carcinoma recei…

2020

Analgosedierungsverfahren f�r zahn�rztlich-chirurgische Eingriffe mit Midazolam/Pentazocin und Midazolam/Ketamin Klinische Doppelblindstudie zu Anxio…

1995

Ketamin/Midazolam zur Analgosedierung erwies sich in bezug auf Kreislauf und Atmung gegenuber Pentazocin/Midazolam uberlegen [23]. Diese Studie sollte klaren, ob 0,25 oder 0,5 mg/kg KG Ketamin, 0,075 mg/kg KG Midazolam, unter den Aspekten Anxiolyse, Analgesie, Sedierung und Amnesie eine Alternative zu Pentazocin/Midazolam ist. Kontrollgruppe (KG): Lokalanasthesie (LA) mit Articain 4%/Adrenalinzusatz 1:200.000 (n=35); Testgruppe P/M: LA und 0,40 mg/kg KG Pentazocin/0,075 mg/kg KG Midazolam i.v. (n=35); Testgruppe K25/M: LA und 0,25 mg/kg KG Ketamin/0,075 mg/kg KG Midazolam i.v. (n=35); Testgruppe K50/M: LA und 0,50 mg/kg KG Ketamin/0,075 mg/kg KG Midazolam i.v. (n=35). Die LA wurde 3 min nac…

Pioneer: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Avapritinib in Patients with Indolent or Smoldering Systemic Mastocytosis w…

2019

Background: The gain-of function mutation KIT D816V plays a central role in the pathogenesis of systemic mastocytosis (SM). Among subtypes of SM, indolent SM (ISM) is the most frequent and is associated with normal/near-normal life expectancy; smoldering SM (SSM) is a subtype with a relatively higher burden of mast cells and may be associated with an increased risk of progression to advanced mastocytosis. However, both ISM and SSM patients may experience severe symptoms associated with mast cell mediator release, such as pruritus, diarrhea, anaphylaxis, and bone pain, which can be severely debilitating and have a profoundly negative impact on quality of life. Symptomatic treatments (eg, ant…

Reply to: “Bio-optimized Curcuma longa extract is efficient on knee osteoarthritis pain: a double-blind multicenter randomized placebo controlled thr…

2020

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OP0015 Induction of remission and maintenance in early, aggressive rheumatoid arthritis using adalimumab in combination with methotrexate with or wit…

2017

Background Remission is the current aim of early RA treatment. In patients with early, aggressive RA, combination with adalimumab (ADA) plus methotrexate (MTX) was superior to either MTX or ADA alone in obtaining clinical remission. Moreover, it has been demonstrated that a short-term aggressive treatment with high-dose glucocorticoids (GC) plus conventional DMARDs lead to long-term (up to 5 years) benefits. Objectives To compare the proportion of patients who achieve remission at 12 months, between two groups of subjects treated with ADA + MTX + high dose GC (intensive) and ADA + MTX + placebo (standard), and to evaluate the proportion of those maintaining remission at 24 months, after dis…