118 results
The ORANGE-II trial is a randomised controlled trial that will provide evidence on the merits of laparoscopic surgery in patients undergoing a left lateral hepatic sectionectomy and participating in an enhanced recovery programme.
The most important purpose of this scientific study is to determine whether the use of tivantinib is safe and effective in patients with liver cancer in which the MET-protein is present in high concentration.
This trial will be a first-in-man study. It should therefore demonstrate the feasibility and accuracy of liver tumor ablation. Since image-guided tumor ablation techniques, such as MR-HIFU, leave the coagulated tumor in situ, treatment accuracy is…
To investigate the effect of expanded adipose-derived allogeneic adult stem cells (eASCs) on the inflammatory response to intravenous LPS in humans.
Introduction of dovitinib in the neo-adjuvant setting, can provide both clinical informationabout it*s activity in patients with HCC (reduction of tumor size, influence on the tumor bloodflow as assessed by CT perfusion imaging) and (histo-)…
Project description:A controlled randomized multicentre prospective clinical trial of 12 months duration at 5 centres. To evaluate and compare appliance of porous titanium granules (PTG) during surgical treatment of peri-implant osseous defects of…
To assess efficacy and safety of temoporfin (Foscan*) photodynamic therapy in the treatment of locally advanced perihilar bile duct carcinoma without distant metastases.
The primary objective of this study is to assess the overall survival (OS) of oral linifanib given as monotherapy daily (QD) compared to sorafenib given twice daily (BID) per standard of care in subjects with advanced or metastatic HCC. The…
The primary objective is to determine the effect of oral talactoferrin alfa on 28-day (672-hour post first dose of study drug) all-cause mortality in patients with severe sepsis.The secondary efficacy objectives are to determine the effect of oral…
To reduce intraoperative blood loss and enhance tolerance of the FRL to I/R injury during right hemihepatectomy under vascular exclusion by means of in situ hypothermic perfusion with retrograde outflow (R-IHP) of the FRL.
Primary objective: The primary objective of the study is to determine the effects of GM-CSF/IFN-γ on the in vivo immunoparalysis induced by human endotoxemia. This will be determined by measuring plasma levels of various pro and anti-inflammatory…
Primary objective:1. Reduction of hospitality duration in patients with CAP treated with intravenous dexamethasone. Secondary objective:1. Reduction of the use of intravenous antibiotics in patients with CAP treated with intravenous dexamethasone.2…
Primary objective:To establish the safety and toxicity profile of treatment with Ho-166-PLLA-MS.Secondary objectives:• To evaluate tumor response. • To evaluate patient dosimetry. • To evaluate performance status.• To evaluate Quality of Life (QOL…
Part 1:- To assess tolerability, safety and PK of escalating single Intravenous (IV) doses of NI-0101 in healthy volunteers with the aim of covering a wide range of plasma concentrations up to those theoretically reflecting a potential therapeutic…
To evaluate safety and efficacy of endobiliary RFA as a treatment for biliary SEMS occlusion caused by tissue ingrowth.
To determine the influence of OATP1B inhibition, through rifampicin exposure, on the metabolism and plasma pharmacokinetics of sorafenib and its metabolites.
The primary objective is to compare the overall survival (OS; time from randomization to death) in patients with hepatocellular carcinoma (HCC) who had disease progression during or following sorafenib therapy, or were intolerant to this agent.…
- To asses the safety and toxicity of peri-ablative sorafenib given in doses of either 200 mg or 400 mg twice daily.- To asses the effect of perioperative sorafenib on the RFA induced mobilization of endothelial progenitor cells and cytokines…
Phase I- To characterize the safety and tolerability and determine the maximum tolerated dose of daily RAD001 in combination with daily sorafenibPhase II- To estimate the hazard ratio of the treatment effect as measure of anti-tumor activity of the…
To establish: 1) the effectiveness of adenoidectomy compared to a non-surgical strategy in children in terms of reduction of upper respiratory tract infections (with or without fever) and improvement in quality of life 2) the costs-effectiveness of…