Search results for "CLINICAL TRIALS"
showing 10 items of 490 documents
Helicobacter pylori Infection as a Triggering Factor of Attacks in Patients with Hereditary Angioedema
2007
Udgivelsesdato: 2007-Jun BACKGROUND: Helicobacter pylori infection is considered among the causative factors of urticaria and angioedema. Having conducted a study on 65 patients, Hungarian authors reported in 2001 that successful eradication of H. pylori is followed by a significant reduction in the number of attacks in patients with hereditary angioedema (HAE). The present study aimed to reinvestigate the relationship between H. pylori infection and the attack rate in the framework of an international collaborative study. MATERIALS AND METHODS: Within the framework of the PREHAEAT project launched by the European Union, further 152 patients were studied in seven collaborating centers, an…
Construction of quality of life change patterns: example in oncology in a phase III therapeutic trial (FFCD 0307)
2015
Objective Quality of life data in cancerology are often difficult to summarize due to missing data and difficulty to analyze the pattern of evolution in different groups of patients. The aim of this work was to apply a new methodology to construct Quality of Life (QoL) change patterns within patients included in a clinical trial comparing to regimen of treatment in locally advanced eosogastric cancer. Materials and methods In this trial, QoL was assessed every 2 months by self-reported EORTC QLQ-C30 questionnaire. Physical dimension scores were analyzed. After multiple imputation of missing data, 27 statistical measures aiming to describe the variation of QoL measures among follow-up were c…
Replacement therapy for alpha-1-protease inhibitor deficiency in PiZ subjects with chronic obstructive lung disease
1988
In a six-month multicenter feasibility and safety study, 20 patients, who all had a congenital deficiency of alpha-1-protease inhibitor (A1PI) of the PiZ phenotype accompanied by a chronic obstructive lung disease, were treated with human-plasma-derived A1PI. A weekly dose of 60 mg/kg, administered intravenously, was shown to be sufficient to maintain patient serum levels above the threshold limit of 35 percent, the serum level of healthy persons of the MZ phenotype. This is supposed to be the minimal effective level for protection against the elastolytic attack of the lung and, therefore, satisfies one of the most important criteria of feasibility of long-term replacement therapy. The glob…
Accumulated safety data of micafungin in therapy and prophylaxis in fungal diseases
2011
To define better the safety profile of micafungin, an analysis of micafungin clinical trial safety data was undertaken.Adverse event data were pooled worldwide from 17 clinical efficacy and safety studies. Adverse events were coded using the Medical Dictionary for Regulatory Activities version 5.0.In the pooled clinical trial data set, 3028 patients received at least one dose of micafungin. The mean age of patients was 41.4 years; with 296 (9.8%) children (16 years) and 387 (12.8%) elderly patients (≥ 65 years). Common underlying conditions were hematopoietic stem cell and other transplantations (26.1%), malignancies (20.8%) and HIV (32.9%). Mean exposure was 18 days for adults and 29 days …
LDL size: does it matter?
2004
The atherogenic lipoprotein phenotype is characterised by a moderate increase in plasma triglycerides, a decrease in high density lipoprotein cholesterol and the prevalence of smaller denser low density lipoprotein particles. The prevalence of this partially inheritable phenotype is approximately 30% and is a feature of the metabolic syndrome associated with an increased risk for cardiovascular events. The predominance of small dense LDL has been accepted as an emerging cardiovascular risk factor by the adult treatment panel (ATP) III.
Dose-response relationships and plasma concentrations of digitalis glycosides in man.
1978
An inter-individual, randomized, double-blind study of digitoxin (Dt) and β-acetyl digoxin (D) was performed in 120 healthy male volunteers. Groups of 10 persons each received orally D 0, 0.1, 0.2, 0.3, 0.4, 0.5 or 0.6 mg and Dt 0.04, 0.08, 0.12, or 0.16 mg daily for 7 days; Loading doses were given for the first three days. Plasma levels were measured with an86Rb-erythrocyte assay 24 h after the last dose. ECG, carotid artery pulse and phonocardiogram were recorded prior to (b) and 24 h after (a) the last dose. QTc, amplitude of T-waves in V2 to V6, electromechanical systole (QS2c) and left ventricular ejection time (LVETc) were measured. The differences between a and b (Δ-values) reflect …
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.
Ciclosporin and prednisone v. prednisone in treatment of Graves' ophthalmopathy: a controlled, randomized and prospective study.
1986
Forty patients with Graves' ophthalmopathy stages III-V were divided into two groups in a random manner according to their year of birth. Group I received prednisone in decreasing dosage. Group II received prednisone at a comparable dosage and ciclosporin. Steroids were discontinued after 10 weeks in the two groups. In the patients of group II, ciclosporin was continued over 12 months. The therapeutic effect was assessed by an activity score based on subjective and objective symptoms (computerized tomography and sonography of the orbit, Hertel values, clinical findings). All signs of endocrine ophthalmopathy improved significantly in both groups (P less than 0.01 in group I; P less than 0.0…
Double-blind cross-over study with oral alpha-ketoacids in patients with chronic renal failure.
1980
In 15 ambulatory patients with renal insufficiency (creatinine clearance, 9.9 +/- 3.0 ml/min) the effect of oral supplementation with alpha-ketoacids has been compared with that of placebo. The protein intake amounted to 0.55 g protein per kilogram body weight of high biological value, as estimated by dietary recordings. After a control period of 3 months the patients received, in a double-blind study, 1.05 g alpha-ketoacids/10 kg body weight per day or a placebo for 6 weeks with a subsequent cross-over. Fasting blood samples were analyzed at 3-week intervals for routine laboratory parameters and 17 proteins. Anthropometric and clinical data have been recorded every 3 weeks. While therapy w…
"Baseline physical functioning status of metastatic colorectal cancer patients predicts the overall survival but not the activity of a front-line oxa…
2010
BACKGROUND: No differences in response rate (RR), progression-free survival (PFS), overall survival (OS) and quality of life (QoL) were seen in patients randomly treated with biweekly oxaliplatin plus either fluorouracil/folinic acid or capecitabine. METHODS: We investigated the independent effect of baseline clinical characteristics and physical functioning (PF) domain on RR, PFS, and OS in 310 patients who completed the EORTC QLQ-C30 questionnaire. Multivariate analyses stratified by treatment were performed. An exploratory analysis was done by grouping patients with a PF score superior or equal to the highest quartile (n = 111), included between the highest and the lowest quartiles (n = …