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The use of perioperative antibiotic prophylaxis in the treatment of acute cholecystitis, a randomized, multicenter, non-inferiority trial

To provide high level of evidence that omitting perioperative antibiotic prophylaxis does not increase the postoperative infection rate, in patients with acute calculous cholecystitis undergoing laparoscopic cholecystectomy.

A multi-center randomized, open label, controlled study in primary liver transplantation comparing long term renal function in recipients treated with standard dose extended release tacrolimus alone and recipients treated with a combination of low dose extended-release tacrolimus and low dose sirolimus.

To evaluate the effectiveness and safety of concentration controlled combination of once daily dosed low-dose sirolimus (trough levels: 3-5 ng/ml) and extended-release tacrolimus (trough levels:3-5 ng/ml), in order to provide superior renal function…

Transjugular Intrahepatic Porto-systemic Shunt (TIPS) with Gore-tex covered stent-graft versus endoscopic treatment for acute bleeding of esophageal varices.

The aim of this study is to compare the new (covered) TIPS stent with the standard treatment, local band ligation and/or sclerosing of the bleeding vessel under endoscopic guidance, in patients with acute bleeding of esophageal varices, with regard…

A randomised, controlled clinical trial assessing the efficacy of;Lanreotide to halt disease progression in ADPKD

First, to demonstrate whether Lanreotide attenuates progression of the renal phenotype in ADPKD patients as measured by change in rate of renal function decline and change in renal volume. Second, to demonstrate whether Lanreotide modifies…

MAGNITUDE-A Phase 3 Evaluation of the Safety and Efficacy of Lambda/RBV/DCV in Treatment Naïve Subjects with Chronic HCV Infection, who have Underlying Mild or Moderate Hemophilia or Patients who are Prior Relapsers to Pegylated interferon alfa/RBV;Revised Protocol 01 Incorporates Amendment 02 and Administrative Letter 01 and 02;+ Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0, dated 11-Sep-12)

Primary Objectives:The primary objective for this study is to evaluate the proportion of subjects who achieve SVR12 (HCV RNA < LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects with GT-1b, -4 and GT-2, -3.Secondary…

Augmenting response to entecavir using a temporary peginterferon alpha-2a add-on strategy for the treatment of HBeAg-positive chronic hepatitis B (ARES study)
- Long-term follow-up of a peginterferon alpha-2a add-on strategy in chronic hepatitis B patients treated with entecavir

To investigate the use of a temporary peginterferon alpha-2a add-on strategy during entecavir therapy in patients with HBeAg-positive chronic hepatitis B by comparing the efficacy of this regimen versus entecavir monotherapy.To evaluate the long-…

Effect of bile drainage and rifampicin, a pregnane X receptor agonist, on clinical and biochemical recovery of patients with obstructive cholestasis

To study the effect of alleviation of obstructive cholestasis by biliary drainage with or without rifampicin on serum bilirubin levels, quality of life, itch intensity, and serum and/or biliary bile salt, ATX, LPA, FGF-19 and biliary HCO3- levels in…

Extension study to the multicenter, open-label, randomized, controlled study CRAD001H2304 to evaluate the long-term efficacy and safety of concentrationcontrolled
everolimus in liver transplant recipients.

To evaluate the long-term safety and efficacy of two concentration-controlled everolimus regimen in de novo liver transplant recipients at Month 36 post-transplantation.

Group training for Hepatitis C patients to improve quality of life

The objective of the study is to improve quality of life of patients with Hepatitis C, by teaching patients psychological skills that aid in coping with the consequences of the disease.

Lowering viral load with nucleos(t)ide analogues prior to peg-interferon alfa-2b treatment to increase sustained response in HBeAg-positive chronic hepatitis B (PADD-study)

To investigate sustained HBeAg response to peg-interferon alfa-2b in chronic HBeAg-positive hepatitis B patients who are pretreated with nucleos(t)ide analogues, thereby lowering viral loadDetermine the effect of PEG-IFNa on NK cell function and…

Perioperative antibiotic use in the treatment of acute calculous cholecystitis

To demonstrate that extended postoperative antibiotic treatment does not decrease the infectious complication rate in laparoscopic cholecystectomy for acute cholecystitis.

LOWERING VIRAL LOAD WITH NUCLEOS(T)IDE ANALOGUES PRIOR TO PEGINTERFERON ALFA-2B TREATMENT TO INCREASE SUSTAINED RESPONSE IN HBEAG-POSITIVE CHRONIC HEPATITIS B (PEGON-STUDY)

To investigate sustained HBeAg response to peg-interferon alfa-2b in chronic HBeAg-positive hepatitis Bpatients who are pretreated with nucleos(t)ide analogues, thereby lowering viral load

A 24 month, multi-center, open-label, randomized, controlled study to evaluate the efficacy and safety of concentration controlled everolimus to eliminate or to reduce tacrolimus compared to tacrolimus in de novo liver transplant recipients.

To evaluate the use of concentration-controlled everolimus, with the reduction or the elimination of tacrolimus, to provide superior renal function and to provide non-inferior rates of the composite efficacy endpoint compared to the tacrolimus…

Pancreatitis of biliary origin, Optimal timiNg of CHOlecystectomy (PONCHO)

To compare the outcome of early laparoscopic cholecystectomy (<72 hrs after randomization) with interval laparoscopic cholecystectomy (25-30 days after randomization) after mild biliary pancreatitis.

The effects of preventive versus on demand nutritional advice and support on the nutritional status of patients during antiviral therapy for hepatitis C

Primary:Assessment of the effect of preventive versus on demand nutritional advice and a nutritional supplement (a daily energy- and protein-rich evening snack) on weight loss of patients receiving standard antiviral therapy with PEG-interferon in…

Everolimus added to long acting octreotide as a volume reducing treatment of polycystic livers.

Reduction of polycystic liver volume by treating with octreotide, whether or not combined with everolimus. Assessing whether combination therapy of everolimus and octreotide gives a bigger reduction of polycystic liver volume than octreotide…

A twelve-month, multicenter, randomized, open-label study of safety, tolerability and efficacy of Certican-based regimen versus calcineurin inhibitor-based regimen in de novo liver transplant recipient

The study is designed to show that Certican® initiation together with reduction and thereafter discontinuation of calcineurin inhibitor (CNI) will improve significantly renal function in de novo liver transplant recipients as compared to…

A Modified Case Control Study To Identify Pharmacogenomic Factors Associated With Hepatocellular Injury Following Exposure To Lapaquistat Acetate

To examine the genetic contribution to the mechanism of lapaquistat acetate induced hepatic abnormalities.

A randomized open-label prospective trial for comparing combination therapy Peg-Interferon alfa-2a (PEGASYS®) and Adefovir dipivoxil (Hepsera®) and combination therapy Peg-Interferon alfa-2a (PEGASYS®) and Tenofovir disoproxil fumarate (Viread®) versus no treatment in HBeAg negative chronic hepatitis B patients with low viral load*

The aim of this study is to investigate what proportion of HBeAg negative, inactive carriers of the hepatitis B virus with low (< 20,000 IU/mL) load will lose HBsAg when treated with nucleot(s)ide analogue/Peg-IFN combination therapy.

TIPS with PTFE covered stents vs paracentesis + albumin infusion for the treatment of refractory ascites in patients with cirrhosis: a randomized trial comparing survival, quality of life and nutritional status.

The aim of this study is to compare the new covered TIPS-stent with paracentesis with albumin infusion with regard to nutritional status, quality of life and survival. The theory is that when ascites is treated in an earlier stage of liver cirrhosis…