Search results for "PLACEBO"
showing 10 items of 704 documents
Effect of caffeine on simulator flight performance in sleep-deprived military pilot students.
2007
Caffeine has been suggested to act as a countermeasure against fatigue in military operations. In this randomized, double-blind, placebo-controlled study, the effect of caffeine on simulator flight performance was examined in 13 military pilots during 37 hours of sleep deprivation. Each subject performed a flight mission in simulator four times. The subjects received either a placebo (six subjects) or 200 mg of caffeine (seven subjects) 1 hour before the simulated flights. A moderate 200 mg intake of caffeine was associated with higher axillary temperatures, but it did not affect subjectively assessed sleepiness. Flight performance was similar in both groups during the four rounds flown und…
Tree-pollen allergy is efficiently treated by short-term immunotherapy (STI) with seven preseasonal injections of molecular standardized allergens.
1998
The efficacy and tolerance of short-term immunotherapy (STI) by seven preseasonal injections of tree-pollen allergens (ALK7 Fruhbluhermischung) was investigated in a double-blind, placebo-controlled, multicenter study with 111 rhinoconjunctivitis patients. Nasal and bronchial symptoms simultaneously analyzed, and nasal symptoms as a single end point, but not the overall score of nasal, bronchial, and conjunctival symptoms, showed a significantly lower increase with STI during birch-pollen exposure (both P=0.033, n=105, Mann-Whitney U-test). However, a selective analysis with patients from centers with high recruitment figures (n> or =10 patients, n=29 STI, n=32 placebo) showed a significant…
Oral 5-aminosalicylic acid (Asacol) in the maintenance treatment of Crohn's disease
1992
A randomized, placebo-controlled multicenter trial was conducted to evaluate the efficacy and safety of a delayed-release formulation of 5-aminosalicylic acid (5-ASA) (Asacol; GiulianiBracco, Milan, Italy) for prevention of clinical relapse in 125 patients with inactive Crohn's disease. Patients in remission [Crohn's Disease Activity Index (CDAI) less than 150] between 3 months and 2 years were randomly allocated to receive either 800 mg 5-ASA three times daily (n = 64) or placebo (n = 61) for up to 12 months or until relapse of symptoms. Relapse was defined by a CDAI greater than 150, with a minimum increase of 100 points over the baseline value. The cumulative relapse rates were 12% in th…
Apomorphine-Induced Growth Hormone Response Is Attenuated by Ethanol but Not Dextromethorphan
2007
Background: Misuse of alcohol drinking is a major health problem. Alcohol decreases spontaneous growth hormone (GH) secretion, but the mechanism is unclear. The aim of this study was to test whether administration of alcohol (study 1) or a N-methyl d-aspartate (NMDA) receptor antagonist (study 2) attenuates the GH response to pharmacological dopaminergic stimulation. Methods: The 2-session repeated measures design was conducted at the endocrine laboratory at the Department of Psychiatry at the Free University Berlin. Twenty healthy Caucasian males aged 35±10 years without a history of alcohol use disorders were tested using the Apomorphine (APO) challenge test. In study 1, we injected APO (…
Effects of Clomipramine on Sleep EEG and Nocturnal Penile Tumescence
1988
The effects of the tricyclic antidepressant clomipramine on sleep EEG and nocturnal penile tumescence (NPT) were investigated during a long-term study in a normal male control subject. During 21 consecutive days the subject received first placebo for 3 days, then stepwise increasing dosages of clomipramine for 10 days, and finally placebo after withdrawal for 8 days. Under clomipramine, rapid eye movement (REM) sleep was suppressed markedly; an REM rebound occurred after withdrawal. Awake and stages 1 and 2 increased while slow wave sleep was diminished under clomipramine. Those non-REM parameters returned to baseline values after drug cessation. NPT was reduced simultaneously with REM slee…
Anti–Interleukin-12 Antibody for Active Crohn's Disease
2004
Crohn's disease is associated with excess cytokine activity mediated by type 1 helper T (Th1) cells. Interleukin-12 is a key cytokine that initiates Th1-mediated inflammatory responses.This double-blind trial evaluated the safety and efficacy of a human monoclonal antibody against interleukin-12 (anti-interleukin-12) in 79 patients with active Crohn's disease. Patients were randomly assigned to receive seven weekly subcutaneous injections of 1 mg or 3 mg of anti-interleukin-12 per kilogram of body weight or placebo, with either a four-week interval between the first and second injection (Cohort 1) or no interruption between the two injections (Cohort 2). Safety was the primary end point, an…
Results from two pharmacotherapy trials show alcoholic smokers were more severely alcohol dependent but less prone to relapse than alcoholic non-smok…
2007
Aims: To assess the role of smoking on treatment outcome in quitting alcoholics on the background of the priming or coping hypothesis (Rohsenow et al. , [1997][1]). Methods: Data sets of placebo treated patients of the German phase III trial of naltrexone (Gastpar et al. , [2002][2]) and of acamprosate treated patients of a German phase IV trial Soyka et al. , [2002][3]) were reanalyzed. Differences between smoking and non-smoking alcoholics were evaluated using χ2-, t - or ANOVA-tests, relapse rates using survival techniques with Cox regression. Results: Smoking alcoholics differed significantly from non-smoking alcoholics regarding sociodemographic variables (e.g. more males, more often l…
Intravenous immunoglobulin in primary and secondary chronic progressive multiple sclerosis: a randomized placebo controlled multicentre study
2007
In patients with relapsing-remitting multiple sclerosis (MS), IVIG was shown to reduce the relapse rate and progression of disability. In patients with chronic progressive MS, a beneficial effect of IVIG was not documented in placebo controlled studies. This trial investigated the influence of IVIG in primary (PPMS) and secondary (SPMS) chronic progressive MS. Two-hundred and thirty-one patients stratified for PPMS ( n = 34) and SPMS ( n = 197) were randomly assigned to IVIG 0.4 g/kg per month or to placebo for 24 months. Primary endpoints were 1) the time to sustained progression of disease identified as worsening of the expanded disability status scale (EDSS) sustained for 3 months, and …
Investigation into isoprenaline resistance in patients with obstructive lung disease
1974
12 patients with chronic obstructive lung disease have been studied in an investigation regarding the causes of resistance to isoprenaline. The effects of repeated intravenous doses of 10 µg isoprenaline were assessed by cross over comparison before and after infusions of isoprenaline and a placebo; the infusions lasted for 35 to 40 min and the amount of isoprenaline infused was 0.5 µg/min. Total resistance, thoracic gas volume (whole-body plethysmography) and heart rate (ECG) were measured. No decrease in bronchospasmolytic or positive chronotopic effects on single isoprenaline injections could be demonstrated after prolonged infusions of isoprenaline.
Assessment of the long-term safety of mepolizumab and durability of clinical response in patients with severe eosinophilic asthma
2018
Background Mepolizumab has demonstrated favorable safety and efficacy profiles in placebo-controlled trials of 12 months' duration or less; however, long-term data are lacking. Objective We sought to evaluate the long-term safety and efficacy of mepolizumab in patients with severe eosinophilic asthma (SEA). Methods COLUMBA (Open-label Long Term Extension Safety Study of Mepolizumab in Asthmatic Subjects, NCT01691859 ) was an open-label extension study in patients with SEA previously enrolled in DREAM (Dose Ranging Efficacy And Safety With Mepolizumab in Severe Asthma, NCT01000506 ). Patients received 100 mg of subcutaneous mepolizumab every 4 weeks plus standard of care until a protocol-def…