25 results
This study has been transitioned to CTIS with ID 2023-506637-30-00 check the CTIS register for the current data. The main objective of this study is to determine whether lowering estrogen and progesterone levels with leuprorelin decreases liver…
The primary aim of the study is to assess the prevalence of MDRO carriage in patients undergoing ERCPs. This will be performed in four different countries with expected significantly different prevalence rates of MDRO carriage, namely: India, United…
To establish the effectiveness and safety of EUS-CD as the primary drainage strategy in patients with malignant distal biliary obstruction.
To compare the in vitro potency of commonly used antiplatelet drugs in the blood of patients with various stages of fibrosis due to MAFLD, compared to that in blood of individuals without underlying liver disease.
The main objective is to compare laparoscopic fenestration and aspiration sclerotherapy in patients with large symptomatic hepatic cysts on patient-reported outcomes. This information can be used to assess cost-effectiveness in both treatments.
Primary Objective: • Efficacy: To evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on alkalinephosphatase (ALP) and total bilirubin at 12 months of treatment compared to placebo• Safety:…
To investigate:- Whether a harm reduction strategy with education and counseling is effective in reducing the use of AAS by amateur athletes. - The harm reduction potential of an additional online consultation with a well-known fitness expert. -…
The aim of this study is to compare the effectiveness of TAC with MMF as a second line treatment for AIH. Proportion of patients with CR after 12 months of treatment will be the primary outcome parameter to determine effectivity.
The overall aim of the study is to gain more insight in as well as understand and map the pharmacokinetics of tacrolimus during pregnancy. Therefore, we will study tacrolimus concentrations in maternal whole blood (routine care) and via area under…
The trial will compare two doses of BI 685509 (2 mg and 3 mg BID) with placebo, on top of standard of care, in patients with CSPH in compensated alcohol-related cirrhosis. The primary objective is to estimate the mean difference between treatment…
Primary objective:1. To determine the association between insulin-stimulated hepatic glucose uptake rate measured by dynamic [18F]-FDG PET and hepatic fat content in overweight/obese subjects. Exploratory objectives:1. To compare insulin-stimulated…
Are the elevated levels of oxylipins seen in itching cholestatic patients responsible for typical itch by activating TRPA1?
In this study we will investigate how quickly and to what extend the approved compounds repaglinide, tolbutamide, midazolam or caffeine are absorbed and eliminated from the body when it is given together with PXL770. This study is a drug-drug…
To characterize the immune response and gene expression profiles in blood of chronic HBV patients who present with a flare after treatment with antiviral therapy in order to be able to predict spontaneous resolution of flares in the future.
The primary objective of this observational study is:- to determine if patients with Chronic Liver Disease (CLD) mount comparable humoral immune responses to healthy controls at 8-months following SARS-CoV-2 vaccination.Secondary objectives of this…
This study has been transitioned to CTIS with ID 2024-511753-22-00 check the CTIS register for the current data. Primary:• To evaluate the long-term safety and tolerability of seladelparSecondary:• To evaluate the long-term efficacy of seladelpar•…
The main trial objectives are to demonstrate a non-flat dose response curve, to evaluate the size of the treatment effect (using the absolute difference in proportions of patients with histological improvement between BI 456906 and placebo at week…
In this study we will investigate how safe the new compound INT-787 is and how well it is tolerated when it is used by healthy participants.We also investigate how quickly and to what extent multiple doses of INT-787 are absorbed, transported,…
To compare the median time-to-symptom-onset in patients with an internal external PTBD catheter without daily flushing compared to median time-to-symptom-onset in patients with an internal external PTBD catheter who daily flush the catheter.Symptoms…
Primary objective: To establish the safety of acquiring 2D and 3D hybrid images using IXSI in an interventional setting. Secondary objectives: To evaluate dosimetry of SPECT/CBCT acquired by IXSI. To image the (hemo-)dynamic processes influencing…