Search results for "Placebo"
showing 10 items of 704 documents
Influenza vaccine concurrently administered with a combination measles, mumps, and rubella vaccine to young children.
2010
Children aged 11 to <24 months received 2 intranasal doses of live attenuated influenza vaccine (LAIV) or placebo, 35+/-7 days apart. Dose 1 was administered concomitantly with a combined measles, mumps, and rubella vaccine (Priorix). Seroresponses to measles and mumps were similar between groups. Compared with placebo, response rates to rubella in LAIV+Priorix recipients were statistically lower at a 15 IU/mL threshold (83.9% vs 78.0%) and the prespecified noninferiority criteria were not met. In a post hoc analysis using an alternate widely accepted threshold of 10 IU/mL, the noninferiority criteria were met (93.4% vs 89.8%). Concomitant administration with Priorix did not affect the over…
Effect of high-caloric nutrition on serum neurofilament light chain levels in amyotrophic lateral sclerosis
2020
Recent publications showed that circulating neurofilaments (Nfs) may be used as a diagnostic biomarker distinguishing amyotrophic lateral sclerosis (ALS) from ALS mimics with high sensitivity and specificity.1–3 Furthermore, it has been shown that patients with higher Nf levels show faster disease progression1 and shorter survival.2 3 Nf levels remain rather stable during the course of disease.2 Current literature suggests that the diagnostic value of neurofilament light chains (NfL) and phosphorylated neurofilament heavy chains in cerebrospinal fluid is about equal, whereas in blood NfL seems to be superior.4 In this study, we investigated the effect of a high-caloric fatty diet (HCFD) on …
Obeticholic Acid and Fibrates in Primary Biliary Cholangitis: Comparative Effects in a Multicentric Observational Study
2021
INTRODUCTION: Obeticholic acid (OCA) and fibrates therapy results in biochemical improvement in placebo-controlled trials in patients with primary biliary cholangitis and insufficient response to ursodeoxycholic acid. There is scarce information outside of clinical trials. Therefore, we have assessed the effectiveness and adverse events of these treatments. METHODS: Data from patients included in the ColHai registry treated with OCA, fibrates, or both were recorded during a year, as well as adverse events and treatment discontinuation. RESULTS: Eighty-six patients were treated with OCA, 250 with fibrates (81% bezafibrate; 19% fenofibrate), and 15 with OCA plus fibrates. OCA group had baseli…
Use of famotidine in severe exocrine pancreatic insufficiency with persistent maldigestion on enzymatic replacement therapy. A long-term study in cys…
1992
In patients with pancreatic exocrine insufficiency, the use of pancreatic enzyme does not abolish steatorrhea in some cases. We carried out a long-term prospective study in an attempt to clarify the effectiveness of the associated use of famotidine to enzymatic supplementation on fat absorption and nutritional parameters of patients with pancreatic insufficiency due to cystic fibrosis. We studied 10 patients, mean age 12.5 years, with persistent steatorrhea on enzymatic supplementation. A double-blind crossover design was used and famotidine (1 mg/kg/day) or placebo was given as adjuvant to enzymatic preparations for either of two six-month periods. A statistically significative reduction i…
Effects of nicotinamide adenine dinucleotide hydride on physical and mental performance
2007
The aim of this study was to assess the effects of nicotinamide adenine dinucleotide hydride (NADH) on maximal oxygen uptake (VO2max), maximal anaerobic running time, and mental performance. Eight men were exposed to a supplement treatment (30 mg NADH as ENACHI tablets per day) and to a placebo treatment, each of 4 weeks' duration, in a balanced, double-blind, and cross-over design. The two treatments were separated by a 14-week wash-out period. The results indicated that VO2max, maximal anaerobic running time, and the ability to concentrate were similar in the NADH and placebo conditions. There were also no differences in blood lactate, creatine kinase, reaction time or feelings of fatigue…
Acetylcholinesterase inhibitors are associated with weight loss in older people with dementia: A systematic review and meta-analysis
2016
We conducted a systematic review and meta-analysis investigating the influence of acetylcholinesterase inhibitors (AChEIs) therapy on nutritional status and weight across observational and interventional studies. Two authors searched major electronic databases from inception until 10/14/2015 for longitudinal, open-label and randomised double-blind placebo controlled (randomised controlled trials (RCTs)) studies of AChEIs in patients with dementia reporting nutritional status outcome data. Out of 3551 initial hits, 25 studies (12 open-label trials, 9 RCTs and 4 longitudinal studies) including 10 792 patients with dementia were meta-analysed. In longitudinal studies (median follow-up 6 months…
Do Reduced Hospital Mortality Rates Lead to Increased Utilization of Inpatient Emergency Care?:A Population-Based Cohort Study
2018
OBJECTIVES: To measure the impact of the improvement in hospital survival rates on patients' subsequent utilization of unplanned (emergency) admissions.DATA SOURCES/STUDY SETTING: Unplanned admissions occurring in all acute hospitals of the National Health Service in England between 2000 and 2009, including 286,027 hip fractures, 375,880 AMI, 387,761 strokes, and 9,966,246 any cause admissions.STUDY DESIGN: Population-based retrospective cohort study. Unplanned admissions experienced by patients within 28 days, 1 year, and 2 years of discharge from the index admission are modeled as a function of hospital risk-adjusted survival rates using patient-level probit and negative binomial models. …
Oral vitamin K versus placebo to correct excessive anticoagulation in patients receiving warfarin: A randomized trial
2009
BACKGROUND: Low-dose oral vitamin K decreases the international normalized ratio (INR) in overanticoagulated patients who receive warfarin therapy. Its effects on bleeding events are uncertain. OBJECTIVE: To see whether low-dose oral vitamin K reduces bleeding events over 90 days in patients with warfarin-associated coagulopathy. DESIGN: Multicenter, randomized, placebo-controlled trial. Randomization was computer-generated, and participants were allocated to trial groups by using sequentially numbered study drug containers. Patients, caregivers, and those who assessed outcomes were blinded to treatment assignment. SETTING: 14 anticoagulant therapy clinics in Canada, the United States, and …
Efficacy of the long-acting nitro vasodilator pentaerithrityl tetranitrate in patients with chronic stable angina pectoris receiving anti-anginal bac…
2013
Background The organic nitrate pentaerithrityl tetranitrate (PETN) has been shown to have ancillary properties that prevent the development of tolerance and endothelial dysfunction. This randomized, double-blind, placebo-controlled, multicentre study (‘CLEOPATRA’ study) was designed to investigate the anti-ischaemic efficacy of PETN 80 mg b.i.d. (morning and mid-day) over placebo in patients with chronic stable angina pectoris. Methods and results A total of 655 patients were evaluated in the intention-to-treat population, randomized to PETN (80 mg b.i.d., n = 328) or placebo ( n = 327) and completed the study. Patients underwent treadmill exercise tests at randomization, after 6 and 12 wee…
Mucositis in irradiated cancer patients: effects of an antiseptic mouthrinse.
2009
Objective: To assess the effects of an antiseptic, non-alcohol based mouth-rinse containing chlorhexidine and cetylpyridinium chloride, in preventing the oral complications associated to radiation therapy in head-and-neck cancer patients. Study design: This was a parallel, double blind, prospective, randomized clinical trial. Cancer patients were randomly assigned to one of the two treatments (test mouth-rinse or a placebo). Three visits were scheduled (baseline, 14 and 28 days). Different outcome variables were evaluated: mucositis, plaque and gingival indices, stimulated saliva and salivary pH. Results: 70 patients were screened and 36 were included. The presence and the degree of mucosit…