Search results for "endpoint"
showing 10 items of 437 documents
Filgrastim mobilization and collection of allogeneic blood progenitor cells from adult family donors: first interim report of a prospective German mu…
2002
Recombinant human granulocyte colony-stimulating factor (rhG-CSF) mobilized peripheral blood progenitor cells (PBPCs) from healthy individuals are a rapidly emerging alternative source to bone marrow for allogeneic transplantation. Although widely applied in the meantime, only limited information on feasibility and safety of mobilization and collection of PBPCs is currently available from prospective multicenter studies specifically designed to investigate this donation modality. This ongoing multicenter study on the performance as well as the short- and long-term safety profile of rhG-CSF-induced mobilization and collection of PBPCs was initiated in October 1999. The study is designed to r…
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…
Combined treatment of hidradenitis suppurativa with intense pulsed light (IPL) and radiofrequency (RF)
2019
BACKGROUND Hidradenitis suppurativa is a chronic inflammatory disease with high burden. Treatment options are often unsatisfactory. We assessed the effect of a combination therapy of intense pulsed light (IPL) and radiofrequency (RF). METHODS The explorative study included 47 patients and was performed as a prospective, monocentric, randomized, three-arm parallel-group design trial with a prior 12 weeks observation period. Treatment arms were IPL and RF monotherapies or IPL + RF combination therapy. After 12 weeks, all patients received IPL + RF for additional 12 weeks (cross-over). Primary endpoint was the change in active lesion numbers, secondary endpoint the change in Dermatology Qualit…
A Narrative Review about Nutritional Management and Prevention of Oral Mucositis in Haematology and Oncology Cancer Patients Undergoing Antineoplasti…
2021
Cancer is a prevalent disease worldwide, and treatments such as radiotherapy and chemotherapy sometimes lead to adverse events. Oral mucositis is one of the most disabling adverse events, and clinical guidelines do not take into account nutritional interventions. The primary endpoint was to gather the evidence about the efficacy of nutritional interventions in the prevention and/or treatment of antineoplastic-induced oral mucositis in oncological patients. A bibliographic review was carried out in the PubMed data base by combining MeSH terms with Boolean operators. Articles were selected based on inclusion and exclusion criteria; 50 final articles were found. Although further evidence is ne…
Interferon- and ribavirin-free therapy with new direct acting antivirals (DAA) for chronic hepatitis C improves vascular endothelial function.
2018
Abstract Introduction Chronic Hepatitis C virus infection (HCV) is associated with extrahepatic manifestations and an increased prevalence in cardiovascular disease. New direct acting antivirals (DAA) have revolutionized HCV treatment with high rates of sustained virological response (SVR). Recently it was demonstrated, that SVR reduces morbidity and overall mortality more than can be solely explained by hepatic effects, suggesting that treatment with DAA also affects cardiovascular disease. The aim of this pilot study was to identify possible underlying mechanisms behind the HCV-associated cardiovascular mortality reported by others. Methods and results 20 HCV patients (10 genotype GT1, 10…
NOA-05 phase 2 trial of procarbazine and lomustine therapy in gliomatosis cerebri.
2011
The NOA-05 multicenter trial was performed to analyze the efficacy of primary chemotherapy with procarbazine and lomustine (PC) in patients with gliomatosis cerebri (GC) and to define clinical, imaging, and molecular factors influencing outcome.Thirty-five patients with previously untreated GC were treated with up to six 56-day courses of 110mg/m(2) lomustine on day 1 and 60mg/m(2) procarbazine on days 8 to 21. The primary endpoint was the rate of patients without therapy failure (defined as progressive disease, death from any cause, or termination of PC therapy before the end of course 4) at 8 months after the beginning of PC chemotherapy.The failure-free survival rate at 8 months was 50.3…
Prospective, Single-Arm, Longitudinal Study of Biomarkers in Real-World Patients with Severe Asthma.
2019
ARIETTA was a prospective, single-arm, noninterventional, multicenter study in patients with severe asthma.To examine the predictive and prognostic abilities of type 2 biomarkers for severe asthma outcomes.Adult patients with severe asthma receiving daily inhaled corticosteroids (fluticasone propionate ≥500 μg or equivalent) and ≥1 second controller medication were enrolled. Biomarker, clinical, and safety data were collected over 52 weeks. The primary endpoint was the asthma exacerbation rate over 52 weeks in serum periostin-high (≥50 ng/mL at baseline) versus periostin-low subgroups (50 ng/mL). Correlations between biomarker levels (periostin, blood eosinophils, IgE, and fractional exhale…
Laparoscopic gastric banding as a universal method for the treatment of patients with morbid obesity.
2004
Introduction: This study analyzed the influence of potentially negative predictors such as sweet-eating behavior, super-obesity, social and psychological status, family and education situation, intake of sedative drugs, and the distance between hospital and home on the outcome of laparoscopic adjustable gastric banding (LAGB). Methods: 77 women and 29 men with mean age 40.6 years (28-47) underwent LAGB. Preoperative mean body weight was 146 kg (99-179), and mean BMI was 48.1 kg/m 2 (36.4-73.5). The influence of the above-mentioned potentially negative predictors on weight loss was the primary end point. Results: Mean follow-up was 44.6 ′ 19.7 months. Follow-up was possible in all but 6 pati…
Efficacy and Safety of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis:A Randomized, Placebo-Controlled, Phase II Study
2017
Objective To determine the effect of selexipag, an oral, selective IP prostacyclin receptor agonist, on the frequency of attacks of Raynaud's phenomenon (RP) in patients with systemic sclerosis (SSc). Methods Patients with SSc-related RP were randomized 1:1 to placebo (n = 38) or selexipag (n = 36) in individualized doses (maximum of 1,600 μg twice daily) during a 3-week titration period. The primary end point was the weekly average number of RP attacks during the study maintenance period, analyzed using a Bayesian approach with a negative binomial model adjusted for baseline number of RP attacks. Other outcome measures included Raynaud's Condition Score (RCS), RP attack duration, and treat…
A German multicenter, randomized phase III trial comparing irinotecan-carboplatin with etoposide-carboplatin as first-line therapy for extensive-dise…
2011
Background This trial was designed to prove superiority of irinotecan over etoposide combined with carboplatin in extensive-disease small-cell lung cancer. Patients and methods Patients were randomly assigned to receive carboplatin area under the curve 5 mg x min/ml either in combination with irinotecan 50 mg/m2 on days 1, 8, and 15 (IP) or etoposide 140 mg/m2 on days 1-3 (EP). Primary end point was progression-free survival (PFS) at 6 months. Secondary end points were overall survival (OS), response rate, and toxicity. Results Of 226 patients, 216 were eligible. Median PFS was 6.0 months [95% confidence interval (CI) 5.0-7.0] in the IP arm and 6.0 months (95% CI 5.2-6.8) in EP arm (P = 0.0…