Search results for "multicenter trial"
showing 10 items of 65 documents
ag) Push-and-pull enteroscopy in the small bowel using the double-balloon technique: results of a prospective European multicenter study.
2005
BACKGROUND AND STUDY AIMS The aim of this study was to evaluate the feasibility, safety, and clinical impact of push-and-pull enteroscopy (PPE) in patients with suspected or documented small-bowel diseases, in a prospective multicenter trial in three European medical centers. PATIENTS AND METHODS A total of 100 patients (mean age 56 +/- 16 years; range 13 - 90) were included at the three institutions between July and November 2004. The leading symptoms were: acute recurrent or chronic gastrointestinal bleeding (n = 64), polyposis syndrome (n = 8), chronic abdominal pain (n = 7), chronic diarrhea (n = 7), and others (n = 14). RESULTS No major PPE-associated complications such as perforation,…
Prospective Multicenter Trial Comparing Push-and-Pull Enteroscopy With the Single- and Double-Balloon Techniques in Patients With Small-Bowel Disorde…
2010
Prospective Multicenter Trial Comparing Push-and-Pull Enteroscopy With the Single- and Double-Balloon Techniques in Patients With Small-Bowel Disorders
Interferon alfa for chronic hepatitis B infection: Increased efficacy of prolonged treatment
1999
Interferon alfa (IFN-alpha) is the primary treatment for chronic hepatitis B. The standard duration of IFN-alpha therapy is considered 16 weeks; however, the optimal treatment length is still poorly defined. We evaluated the efficacy and acceptability of prolonged IFN-alpha treatment in patients with chronic hepatitis B. To investigate whether treatment prolongation could enhance the rate of hepatitis B e antigen (HBeAg) seroconversion, we conducted a prospective, controlled, multicenter trial in which all patients were treated with a standard regimen of 10 million units IFN-alpha 3 times per week over 16 weeks. Patients who were still HBeAg-positive after 16 weeks of therapy were randomize…
alpha-Glycerophosphocholine in the mental recovery of cerebral ischemic attacks. An Italian multicenter clinical trial.
1994
The clinical efficacy and the tolerability of alpha-glycerophosphocholine (alpha-GPC), a drug able to provide high levels of choline for the nervous cells of the brain and to protect their cell walls, have been tested in a clinical open multicenter trial on 2044 patients suffering from recent stroke or transient ischemic attacks. alpha-GPC was administered after the attack at the daily dose of 1000 mg im for 28 days and orally at the dose of 400 mg tid during the following 5 months after the first phase. The evaluation of the efficacy on the psychic recovery was done by the Mathew Scale (MS) during the period of im drug administration, and using the Mini Mental State Test (MMST), the Cricht…
Intraoral electrostimulator for xerostomia relief: a long-term, multicenter, open-label, uncontrolled, clinical trial
2012
Objective A previous sham-controlled multinational study demonstrated the short-term efficacy and safety for xerostomia treatment of an intraoral device that delivers electrostimulation to the lingual nerve. The objective of this study was to test the hypothesis that those beneficial effects would be sustained over an 11-month period. Study Design The device was tested on a mixed sample of 94 patients with xerostomia in an open-label, uncontrolled, prospective multicenter trial. Statutory outcome assessments were done at 5th, 8th, and 11th months and analyzed by multiple comparisons. Results Improvements achieved at month 5 from baseline were sustained throughout the follow-up period for th…
Quadruple-Phase MDCT of the Liver in Patients with Suspected Hepatocellular Carcinoma: Effect of Contrast Material Flow Rate
2006
The purposes of this study were to evaluate the effect of contrast material flow rate (3 mL/sec vs 5 mL/sec) on the detection and visualization of hepatocellular carcinoma (HCC) with MDCT and the safety profile of iodixanol at different injection rates.In a prospective, randomized multicenter trial, 97 patients (83 men and 14 women, with a mean age of 64 years) suspected of having HCC underwent quadruple-phase (double arterial, portal venous, delayed phase) 4-16-MDCT. Patients were randomized to receive iodixanol, 320 mg I/mL (1.5 mL/kg body weight), at a flow rate of 3 mL/sec (48 patients) or 5 mL/sec (49 patients). Qualitative (lesion detection, image quality) and quantitative (liver and …
Aflibercept in Combination With FOLFIRI as First-line Chemotherapy in Patients With Metastatic Colorectal Cancer (mCRC): A Phase II Study (FFCD 1302)
2020
Abstract Background FOLFIRI (irinotecan, 5-fluorouracil, and leucovorin) + aflibercept improves median overall survival (OS) and progression-free survival (PFS) in patients with previously treated metastatic colorectal cancer (mCRC). Our aim was to investigate efficacy and tolerability of this combination in the first line. Patients and Methods Patients with untreated documented mCRC received aflibercept plus FOLFIRI every 14 days until progression or unacceptable toxicity in an open, phase II single-arm, multicenter trial. The primary endpoint was the 6-month PFS rate. Secondary endpoints were OS and tolerability. A 2-step Simon design was used with H0: 55% and H1= 75%. Data were analyzed …
Longitudinal relationship between B-type natriuretic peptide and anxiety in coronary heart disease patients with depression.
2018
Patients with coronary heart disease (CHD) suffer from physical limitations, but also from psychological distress. Natriuretic peptides may be involved in the neurobiological processes that modulate psychological adaptation, as they are increased in heart disease and seem to have an anxiolytic-like function. Longitudinal data on this association are scarce.To assess the relationship between NT-proBNP and anxiety (Hospital Anxiety and Depression Scale (HADS)), we used secondary data from a multicenter trial from baseline to 24 months. Patients (N = 308, 80.8% male, mean age 60.1 years) had stable CHD and moderate levels of depression (HADS ≥8).Multiple linear regression adjusted for age, sex…
Influenza Vaccination After Myocardial Infarction:A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial
2021
Background: Observational and small, randomized studies suggest that influenza vaccine may reduce future cardiovascular events in patients with cardiovascular disease. Methods: We conducted an investigator-initiated, randomized, double-blind trial to compare inactivated influenza vaccine with saline placebo administered shortly after myocardial infarction (MI; 99.7% of patients) or high-risk stable coronary heart disease (0.3%). The primary end point was the composite of all-cause death, MI, or stent thrombosis at 12 months. A hierarchical testing strategy was used for the key secondary end points: all-cause death, cardiovascular death, MI, and stent thrombosis. Results: Because of the COV…
A New Self-Expanding Nitinol Stent (JoStent SelfX) for Palliation of Malignant Biliary Obstruction: a Pilot Study
2004
Background and Study Aims: The JoStent SelfX is a new biliary uncovered self-expanding nitinol stent. The main advantage of this stent in comparison with the gold standard Wallstent is the minimal shortening (< 10%) that occurs during stent deployment. A prospective feasibility study was conducted to evaluate the method of stent implantation and the stent's short-term efficacy. Patients and Methods: Between April 2001 and December 2002, the JoStent SelfX was implanted in 20 patients with inoperable malignant biliary obstructions, mainly caused by pancreatic cancer (12 of 20). All patients underwent sphincterotomy prior to stent insertion. After implantation, laboratory parameters for choles…