Search results for "Multicenter trial"
showing 10 items of 65 documents
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…
Diagnostic performance of gadobenate dimeglumine enhanced MR angiography of the iliofemoral and calf arteries: a large-scale multicenter trial
2007
OBJECTIVE. The purpose of this study was to compare gadobenate dimeglumine–enhanced MR angiography and unenhanced time-of-flight MR angiography for the detection of significant peripheral arterial occlusive disease using digital subtraction angiography as our reference standard. SUBJECTS AND METHODS. Two hundred seventy-two patients underwent MR angiography and digital subtraction angiography of the iliofemoral arteries. MR angiography was performed before (2D time-of-flight acquisitions) and after (spoiled gradient-echo acquisitions) the administration of 0.1 mmol/kg of gadobenate dimeglumine at 1–2 mL/s. Contrast-enhanced MR angiography and digital subtraction angiography of the calf arte…
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…
Peginterferon alfa-2b plus ribavirin for naïve patients with genotype 1 chronic hepatitis C: a randomized controlled trial
2004
We assessed the effectiveness and safety of an induction dose of peginterferon alfa-2b (PEG-IFN) plus ribavirin for initial treatment of patients with genotype 1 chronic HCV infection in a randomized, controlled, multicenter trial.Three hundred and eleven naïve patients infected with genotype 1 and chronic hepatitis were randomly assigned to 48-week treatment with PEG-IFN once weekly (80-100 micrograms depending on body weight for 8 weeks, followed by 50 micrograms for the next 40 weeks), or standard interferon alfa-2b (IFN) 6 million units on alternate days, both in combination with ribavirin (1000-1200 mg/day).PEG-IFN plus ribavirin significantly increased sustained virological response (…
"Readiness to Change" Predicts Efficacy of Reduction among Smokers with Severe Mental Illness.
2018
<b><i>Aims:</i></b> Smoking cessation in subjects with a severe mental illness (SMI) is a challenging but attainable goal. Furthermore, the identification of variables involved in the quitting process is a highly relevant factor in clinical practice. This study aimed to analyze the influence of smokers’ motivation in smoking reduction and cessation and select the most suitable way of measuring motivation. <b><i>Methods:</i></b> This is a secondary analysis of a 9-month, multicenter trial examining a Multicomponent Smoking Cessation Program in 82 adult outpatients with SMI. At the end of the preparation stage, the smokers’ motivational level wa…
Efficacy and safety of an intraoral electrostimulation device for xerostomia relief: a multicenter, randomized trial.
2011
Objective To evaluate the efficacy and safety of an intraoral electrostimulation device, consisting of stimulating electrodes, an electronic circuit, and a power source, in treating xerostomia. The device delivers electrostimulation through the oral mucosa to the lingual nerve in order to enhance the salivary reflex. Methods The device was tested on a sample of patients with xerostomia due to Sjogren's syndrome and other sicca conditions in a 2-stage prospective, randomized, multicenter trial. Stage I was a double-blind, crossover stage designed to compare the effects of the electrically active device with the sham device, each used for 1 month, and stage II was a 3-month open-label stage d…
Quality of life and subjective well-being in schizophrenia and schizophrenia spectrum disorders : Valid predictors of symptomatic response and remiss…
2010
To examine quality of life and subjective well-being as predictors of symptomatic treatment outcome.Biweekly PANSS ratings were performed in 285 inpatients with schizophrenia spectrum disorders within a multicenter trial by the German Research Network on Schizophrenia. Quality of life and subjective well-being were assessed using the Medical Outcomes Study-Short Form 36-Item Health Survey (SF-36), the Subjective Well-being Under Neuroleptic Treatment Scale (SWN-K) and the Adjective Mood Scale (AMS). Response was defined as an initial 20% PANSS total score reduction and remission according to the consensus criteria. Correlation analysis, logistic regression and CART-analysis were performed.I…
Cigarette Smoking Status at Diagnosis and Recurrence in Intermediate-risk Nonemuscle-invasive Bladder Carcinoma
2013
Objective To study the effect of smoking status at diagnosis on recurrence in intermediate-risk non–muscle-invasive bladder carcinoma treated by transurethral resection (TUR) of the bladder and early intravesical chemotherapy. Methods Tumor characteristics and smoking status were recorded in 395 patients entered in a randomized multicenter trial comparing 2 different schedules of early intravesical chemotherapy. All patients received intravesical epirubicin (80 mg/50 mL) within 6 hours after TUR, followed by 5 more weekly instillations with (arm B) or without (arm A) monthly instillations for 1 year. Smoking habit was investigated at diagnosis through a structured questionnaire. Multivariat…
One-year results from the DETOUR I trial of the PQ Bypass DETOUR System for percutaneous femoropopliteal bypass
2019
The objective of this study was to evaluate the 1-year safety and effectiveness outcomes associated with the PQ Bypass DETOUR System (PQ Bypass, Milpitas, Calif) for the percutaneous bypass of long-segment femoropopliteal occlusive disease.This prospective, single-arm, multicenter trial enrolled patients with long-segment femoropopliteal arterial disease. The DETOUR System percutaneously deploys modular stent grafts to bypass femoropopliteal lesions through a transvenous route. Eligible patients included those with TransAtlantic Inter-Society Consensus C and D lesions100 mm in length. The primary safety end point was the major adverse event (MAE) rate through 1 month, defined as the composi…
Response and remission of subjective well-being in patients suffering from schizophrenia spectrum disorders.
2009
AbstractBackgroundPurpose of this study was to assess subjective well-being in schizophrenia inpatients and to find variables predictive for response and remission of subjective well-being.MethodThe subjective well-being under neuroleptic treatment scale (SWN-K) was used in 232 schizophrenia patients within a naturalistic multicenter trial. Early response was defined as a SWN-K total score improvement of 20% and by at least 10 points within the first 2 treatment weeks, response as an improvement in SWN-K total score of at least 20% and by at least 10 points from admission to discharge and remission in subjective well-being as a total score of more or equal to 80 points at discharge. Logisti…