22 results
Part 1: Dose-Escalation Stage (not in The Netherlands)Primary objective:* Safety and tolerability of HBM4003Secondary objectives:* Preliminary anti-tumor activities of HBM4003 in advanced solid tumors* Pharmacokinetics (PK) of HBM4003Other…
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 explore feasibility and efficacy of endoscopic unilateral drainage of patients with presumed perihilar cholangiocarcinoma eligible for major liver resection using a novel fully covered metal stent with a retrieval string.
The objective of the PoCoMiMo study is to compare the abundance, and hepatic clearance of microbiota-derived molecules in the portal venous circulation between patients suffering from a primary hepatic malignancy versus those with pancreatic cancer…
Primary objective: To investigate the feasibility of using intraarterial ICG preoperatively to allow for liver segment visualization during anatomical liver resection.Secondary Objective(s): 1. To investigate the dosage which provides sufficient…
To show that this EMF exposure activates neutrophils in a group of subjects with diversity in age and gender.
To determine the accuracy with which patients with probable or proven invasive pulmonary aspergillosis and neutropenic controls can be discriminated from each other, as measured by the values of the sensitivity, specificity and accuracy.
Primary objective:The objective of this randomized phase 2 study is to demonstrate efficacy of RE in terms of PFS in colorectal cancer patients with liver-only metastases who are candidates for palliative systemic treatment with capecitabine plus…
Over recent years, post-processing software has become available that allows co-registration of pre- and post-ablation CECT. This allows three-dimensional quantitative assessment of ablation margins. Such quantification of ablation margin would…
Primary objective:To establish the safety and toxicity profile of individualized 166Ho-RE in patients with hepatocellular carcinoma. Secondary objectives:• To evaluate efficacy of individualized 166Ho-RE.• To evaluate biodistribution / dosimetry.•…
Primary: Associate acquisition of pneumococcal colonisation with levels of pre-existing polysaccharide specific memory B cells. Secondary: a) To validate the use of synthetic absorptive matrices (SAM) for detection of other (non-pneumococcal)…
Primary Objective:To establish the maximum tolerated healthy liver-absorbed dose of 166Ho-microspheres in patients with HCC who receive RL as a bridge to resection.Secondary Objective(s): 1) To establish dose-response relationships between:a. The…
This study has been transitioned to CTIS with ID 2024-512622-29-00 check the CTIS register for the current data. To determine the maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D) of RLY-4008 and to determine RLY-4008's safety…
The aim of the current study is to assess whether MI combined liver and colorectal resection for CRLMs and primary colorectal tumor can result in shorter time to functional recovery and hereby results indirectly in a lower postoperative complication…
Primary Objectives:Our primary objectives are:1. To evaluate the safety, tolerability and pharmacokinetics of intravenously (IV) administered M6229 in critically ill patients with sepsis with specific attention to anti-coagulation effects (based on…
This study is designed to examine beneficial effects of PLASOMA treatment compared to the standard of care on chronic venous leg ulcers (VLU) that match the size of the plasma area of the pad.The intention is that the data obtained with this study…
The aim of this study is to describe the PK/PD characteristics of frequently used beta-lactam antibiotics in PICU patients. The main objective is to identify whether current antibiotic dosing regimens of the selected beta-lactams achieve defined…
Our proposal builds on 12 years of sustained EU funding, a consortium covering 11 European countries and 27partners (with non-EU sites in African and two Asian populations to provide a global perspective) and our cuttingedge new research, which has…
The main aim of the proposed study is to 1) assess the habitual consumption of raw cow*s milk among a large population of adult dairy farmers; 2) assess the association between raw cow*s milk consumption and inflammation-related, auto-immune and…
The primary objective of this study is to validate the accuracy of FebriDx to discriminate between viral and/or bacterial respiratory infections. Besides this, the predictive value (negative predictive value (NPV) and positive predictive value (PPV…