Search results for "Randomized Controlled Trial"

Cost Effectiveness of Peginterferon ??-2a Plus Ribavirin versus Interferon ??-2b Plus Ribavirin as Initial Therapy for Treatment-Naive Chronic Hepati…

2004

Introduction: In adults with previously untreated chronic hepatitis C (CHC), the combination of peginterferon α-2a plus ribavirin produces a higher rate of sustained virological response (SVR) than interferon α-2b plus ribavirin, but it is still unproven whether this increase is cost effective. The objective of this study was to determine if the gain in SVR with peginterferon α-2a plus ribavirin is worth the incremental cost. Methods: We constructed a Markov model of disease progression in which cohorts of patients received peginterferon α-2a plus ribavirin or interferon α-2b plus ribavirin for 48 weeks (hepatitis C virus [HCV] genotype 1 and non-1 patients with fibrosis) or 24 weeks (genot…

Optimizing the treatment of chronic hepatitis due to hepatitis C virus genotypes 2 and 3: a review

2009

Recently several randomized trials involving exclusively HCV 2 and 3 patients have explored the possibility of reducing the duration of therapy with PEG IFNs and ribavirin to 12–16 weeks. Among these, the largest studies (ACCELERATE, NORTH-C and NORDynamIC) have failed to demonstrate, by intention-to-treat analysis, that short treatment is non-inferior to the standard duration of 24 weeks originated by phase 3 trials. Even though obtaining univocal conclusions from these studies are difficult to obtain due to some critical differences (trial design, genotypes 2/3 ratio, rate of cirrhosis at baseline, ribavirin dose, assays to detect HCV-RNA etc), all have proved that a rapid virological res…

Enoxaparin Prevents Portal Vein Thrombosis and Liver Decompensation in Patients With Advanced Cirrhosis

2012

BACKGROUND & AIMS: We performed a randomized controlled trial to evaluate the safety and efficacy of enoxaparin, a low-molecular-weight heparin, in preventing portal vein thrombosis (PVT) in patients with advanced cirrhosis. METHODS: In a nonblinded, single-center study, 70 outpatients with cirrhosis (Child-Pugh classes B7-C10) with demonstrated patent portal veins and without hepatocellular carcinoma were assigned randomly to groups that were given enoxaparin (4000 IU/day, subcutaneously for 48 weeks; n = 34) or no treatment (controls, n = 36). Ultrasonography (every 3 months) and computed tomography (every 6 months) were performed to check the portal vein axis. The primary outcome was pre…

Atherosclerosis, degenerative aortic stenosis and statins

2009

Aortic stenosis is the most common valvular heart disease among adult subjects in western countries The current treatment for aortic stenosis is aortic valve replacement. The possibility of a medical treatment that can slow the progression of aortic stenosis is very fascinating and statins have been tested to reduce the progression of degenerative aortic stenosis (DAS). The rationale for statin treatment in DAS has a deep pathophysiological substrate, in fact inflammation and lipid infiltration constitute the same histopathological pattern of both aortic stenosis and atherosclerosis and these two conditions have the same risk factors. Whether retrospective studies have shown some efficacy o…

The treatment of portal hypertension: a meta-analytic review.

1995

The necessity of placebo application in psychotropic drug trials.

1990

Randomized Controlled Trials

2011

Background In clinical research, randomized controlled trials (RCTs) are the best way to study the safety and efficacy of new treatments. RCTs are used to answer patient-related questions and are required by governmental regulatory bodies as the basis for approval decisions.

Feasibility and Safety of Laparoscopic Complete Mesocolic Excision (CME) for Right-sided Colon Cancer

2020

OBJECTIVE The aim of this prospective clinical study is to compare short-term outcome of laparoscopic right hemicolectomy using the Complete Mesocolic Excision (CME group) with patients who underwent conventional right-sided colonic resection (NCME group). SUMMARY BACKGROUND DATA Although CME with central vascular ligation in laparoscopic right hemicolectomy is associated with a significant decrease in local recurrence rates and improvements in cancer-related 5-year survival, there may be additional risks associated with this technique because of increased surgical complications. As a result, there is controversy surrounding its use. METHODS In this randomized controlled trial, several prim…

Current state of dynamic surgery. A literature review.

2021

Background Recently, dental implant technology has been widely used for oral reconstruction. Dental implants are the treatment of choice for those patients with dental absences. An optimal implant placement is based on the prosthetic driven concept in order to achieve an aesthetic and functional restoration with a long-term prognosis. There are two types of guided implant surgery that are described in the literature: Static Guided Surgery (SGS) and Dynamic Guided Surgery (DGS). The aim of this study is to be aware of the current state of dynamic surgery and compare in the literature the discrepancies between planning and placement of dental implants. Material and Methods The study consists …

Guidelines for time-to-event end point definitions in sarcomas and gastrointestinal stromal tumors (GIST) trials: results of the DATECAN initiative (…

2015

ABSTRACT The DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials) aims to provide recommendations for definitions of time-to-event end points in cancer randomized controlled trials. We relied on a consensus method based on a multidisciplinary panel of experts to develop these guidelines for trials on sarcomas and gastrointestinal stromal tumors. Background The use of potential surrogate end points for overall survival, such as disease-free survival (DFS) or time-to-treatment failure (TTF) is increasingly common in randomized controlled trials (RCTs) in cancer. However, the definition of time-to-event (TTE) end points is rarely precise and lacks unif…