Search results for "clinical trials as topic"
showing 10 items of 313 documents
[Herpes Zoster and its prevention in Italy. Scientific consensus statement].
2014
In this paper, an Italian group of experts presents a revision of the available data about epidemiology and prevention of Herpes Zoster (HZ). HZ is an acute viral diseases caused by the reactivation of Varicella Zoster Virus (VZV). HZ is characterized by neurological and dermatological symptoms with a dermatomeric localization. The reactivation of the virus from the latent status in the sensitive ganglia increases with age and failing cell mediated immunity. In Europe, more than 95% of adults presents antibodies against VZV. Incidence of HZ is similar all over the world, related to the age of the population: from 2-3/1000 persons/year in the age group 20 to 50 years to 5/1000 in the 60 year…
Participation in adjuvant clinical breast cancer trials: does study participation improve survival compared to guideline adherent adjuvant treatment?…
2012
Abstract Adjuvant clinical trials (CTs) usually compare a standard treatment regime versus an innovative new substance or regimen. Participation in CT however, is available for only few patients and exclusion criteria are usually very strict. Therefore we used an unselected patient cohort to investigate the following questions: (1) Is participation in adjuvant CT associated with improved survival in breast cancer (BC)? (2) What is the impact of guideline conform therapy on survival in BC compared to that of participants in CT? Does guideline-conform adjuvant treatment provide an equal impact? Material and methods This German retrospective multi-centre cohort study included 9433 patients wit…
The Effect of Nitrazepam on Manual Skill, Grip Strength, and Reaction Time with Special Reference to Subjective Evaluation of Effects on Sleep
1978
The effects of 5 and 10 mg oral nitrazepam doses on manual skills, grip strength, and reaction time 8 hours after ingestion of the drugs were studied in 34 healthy female volunteers aged 19-22 years. 5 mg nitrazepam caused a slight but insignificant decrease in psychomotor skills. With 10 mg psychomotor skills were influenced significantly. Grip strength and reaction time were not influenced either by the 5 or 10 mg doses. The investigators corroborate the value of the established effects of nitrazepam as a hypnotic, but recommend that caution should be excercised in prescribing the drug as a hypnotic (especially in doses exceeding 5 mg) to work-aged subjects as there is a risk of significa…
Gastrointestinal disturbances and their management in miglustat‐treated patients
2011
Miglustat (Zavesca®) is approved for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease (GD1) for whom enzyme replacement therapy is unsuitable, and for the treatment of progressive neurological manifestations in adult and paediatric patients with Niemann-Pick disease type C (NP-C). Gastrointestinal disturbances such as diarrhoea, flatulence and abdominal pain/discomfort have consistently been reported as the most frequent adverse events associated with miglustat during clinical trials and in real-world clinical practice settings. These adverse events are generally mild or moderate in severity, occurring mostly during the initial weeks of therapy. The mechanis…
What proportion of chronic obstructive pulmonary disease outpatients is eligible for inclusion in randomized clinical trials?
2013
<b><i>Background and Objective:</i></b> We aimed to explore to what extent an unselected population of chronic obstructive pulmonary disease (COPD) outpatients would be eligible for inclusion in randomized clinical trials (RCTs). <b><i>Methods:</i></b> Retrospective analysis of the clinical records of outpatient subjects with an ascertained diagnosis of COPD. COPD outpatients were assessed against the following inclusion criteria: 40 < age < 80 years, current or former smokers, forced expiratory volume in the first second (FEV<sub>1</sub>) <70% predicted, no long-term oxygen therapy, no other concomitant lung diseases and …
A Phase I–II Study on the Toxicity and Therapeutic Efficacy of 5-Fluorouracil in Combination with Leucovorin and Cisplatinum in Patients with Advance…
1990
5-Fluorouracil (5-FU) has been the treatment of choice for colorectal carcinoma with an overall response rate of about 20%. Recent studies have shown that folate (LV) can increase 5-FU therapeutic efficacy, achieving about a 40% response rate without a clear impact on survival. Cisplatinum (CDDP) is usually inactive in colorectal carcinoma, but the association with 5-FU results in a synergistic antineoplastic effect. A phase I-II study was done to assess the maximally tolerated dose (MTD) of CDDP in association with 5-FU + LV. The MTD for CDDP was 20 mg/m2/wk in association with 5-FU 400-500 mg/m2/wk and LV 500 mg/m2/wk. WHO criteria were used for evaluation of both toxicity and response. I…
Clinical and neuroimaging findings in 33 patients with MCAP syndrome: A survey to evaluate relevant endpoints for future clinical trials
2021
Megalencephaly-CApillary malformation-Polymicrogyria (MCAP) syndrome results from somatic mosaic gain-of-function variants in PIK3CA. Main features are macrocephaly, somatic overgrowth, cutaneous vascular malformations, connective tissue dysplasia, neurodevelopmental delay, and brain anomalies. The objectives of this study were to describe the clinical and radiological features of MCAP, to suggest relevant clinical endpoints applicable in future trials of targeted drug therapy. Based on a French collaboration, we collected clinical features of 33 patients (21 females, 12 males, median age of 9.9 years) with MCAP carrying mosaic PIK3CA pathogenic variants. MRI images were reviewed for 21 pat…
Sublingual administration of captopril in patients with acute myocardial ischemia.
1991
Summary: To investigate the anti-ischemic capability of the angiotensin-converting enzyme inhibitor captopril, 10 patients with acute myocardial ischemia (angina pectoris >1 h, ST-segment depression ±0.1 mV, no rise in creatine phosphokinase) received 25 mg captopril sublingually after being treated with an intravenous infusion of nitroglycerin (3 mg/h) and heparin (1200 IU/h) for 1 hour. A control group of 10 patients received placebo instead of captopril. Results showed a decrease of the initial ST-segment depression from 0.25±0.04 to 0.2±0.03 mV (p>0.01) with nitroglycerin for the captopril group and from 0.26±0.05 to 0.21±0.05 mV (p>0.01) for the control group. An additional decrease to…
Temsirolimus for the treatment of mantle cell lymphoma.
2010
Although recent progress has been made in the treatment of mantle cell lymphoma (MCL) the majority of patients experience relapse and ultimately die of their disease. The translocation t(11;14) is a prerequisite for the diagnosis of MCL and results in overexpression of cyclin D1. Its protein translation is controlled by mTOR, a key element of the PI3K/Akt pathway, and mTOR constitutes an attractive therapeutic target. Temsirolimus, a specific inhibitor of mTOR, has been evaluated in two Phase II trials in patients with relapsed MCL, and promising response rates up to 40% were found. Subsequently, a randomized Phase III trial was initiated, in which superiority in remission induction and pro…
Treatment of Ulcerative Colitis with Olsalazine and Sulphasalazine: Efficacy and Side-Effects
1988
The effects of olsalazine were studied mainly in patients with ulcerative colitis who were intolerant to sulphasalazine, and for relapse prevention. A crossover design with sulphasalazine, 3 g/day, and olsalazine, 1.5 g/day, was applied to compare the side-effects of each drug and to evaluate their therapeutic efficacy. A total of 41 patients with mild or moderately severe left-sided colitis or proctitis were assigned to a randomized treatment schedule. Olsalazine and sulphasalazine were similar in their therapeutic efficacy. Twelve patients complained of adverse effects while on sulphasalazine and 4 patients during olsalazine treatment (p less than 0.05). It is concluded that olsalazine is…