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Standard versus Pre-emptive Antibiotic Treatment to Reduce the Rate of Infectious Outcomes after Whipple procedure (SPARROW): a multicenter, randomized controlled trial

This study has been transitioned to CTIS with ID 2024-510766-16-00 check the CTIS register for the current data. This trial evaluates the additional value of pre-emptive antibiotic treatment on clinically relevant OSIs in patients undergoing…

an open label, randomised, phase 2 study to evaluate the safety and efficacy of mtl-cebpa administered in combination with sorafenib or sorafenib alone, in TKI naïve participants with previously treated advanced hepatocellular carcinoma (HCC) and hepatitis B or hepatitis C virus (outreach2)

We compare the efficacy and safety of the new medication MTL-CEBPA in combination with sorafenib with the efficacy and safety of sorafenib alone. Sorafenib is already being used for the treatment of HCC.

LIVACOR Trial: Minimally invasive LIVer And simultaneous COlorectal Resection

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…

PLASOMA Efficacy & Technology Health study.
A post-market randomised controlled efficacy study of PLASOMA on wound healing in chronic venous leg ulcers.

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…

Right Dose, Right Now: Randomized Controlled Clinical Trial

To assess the influence of dosing guided by AutoK on achieving PK targets and clinical endpoints in intensive care patients with sepsis.

Adjuvant chemotherapy with gemcitabine and cisplatin compared to
standard of care after curative intent resection of cholangiocarcinoma and muscle invasive gallbladder carcinoma (ACTICCA-1 trial)

This study has been transitioned to CTIS with ID 2024-517340-61-00 check the CTIS register for the current data. The primary objective of this study is to evaluate the efficacy of gemcitabine and cisplatin compared with standard of care (adjuvant…

Paediatric Hepatic International Tumour Trial

This study has been transitioned to CTIS with ID 2024-516110-38-00 check the CTIS register for the current data. Primary Objectives:-To evaluate if the treatment of Low Risk HB can be reduced (Group B1)-To compare different induction treatment…

Consequences of early-life antibiotic exposure on antimicrobial gene selection: what regimen causes least harm?

Primary Objective: 1) To assess the short- and long-term prevalence of AMR genes in the microbiome of the gut in infants exposed to broad-spectrum antibiotics in the first week of life compared to controls. 2) To investigate the short- and long-term…

A prospective, multicentre, randomised, controlled study evaluating SIR-Spheres® Y-90 resin microspheres preceding standard cisplatin-gemcitabine (CIS-GEM) chemotherapy versus CIS-GEM chemotherapy alone as first-line treatment of patients with unresectable intrahepatic CholangioCArcinoma.

This study will assess the benefit of adding SIRT to a standard regimen of cisplatin and gemcitabine (CIS-GEM) systemic chemotherapy in unresectable liver-only or liver predominant intrahepatic cholangiocarcinoma.Patients will be offered the…

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients with Nonalcoholic Steatohepatitis (NASH) and fibrosis

Primary objectives * surrogate endpoint (at interim analysis)To evaluate the efficacy of elafibranor QD for 72 weeks versus placebo on resolution of NASH without worsening of fibrosis.* Resolution of NASH is defined as the disappearance of…

ERCP brush cytology of pancreatobiliary strictures - Infinity versus Boston Scientific RX cytology brush: a randomized controlled trial

To compare the sensitivity of ERCP brush cytology between standard RX cytology brush and Inifinity brush in patients with pancreatobiliary strictures suspicious for malignancy.

A Phase III Clinical Trial of Intra-arterial TheraSphere® in the Treatment of Patients with Unresectable Hepatocellular Carcinoma (HCC).

The objective of the study is to evaluate TheraSphere in the treatment of patients with unresectablehepatocellular carcinoma in whom treatment with standard-of-care sorafenib therapy is planned.

A Double-Blind, Placebo-Controlled, Randomized, Multicenter, Proof of Concept and Dose-Finding Phase II Clinical Trial to Investigate the Safety, Tolerability and Efficacy of ADRECIZUMAB in Patients with Septic Shock and Elevated Adrenomedullin

Patients will be evaluated for safety and tolerability of the therapy, but also for signs of clinical efficacy. As long as the patients are on the ICU, measurements of clinical signs and laboratory data will be collected for safety reasons and for…

Safety and Performance Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the reduction of pathogen load from the blood in septic patients with suspected, life-threatening bloodstream infection.

The primary objectives are to demonstrate the safety and performance of the Exthera Medical Seraph 100 Microbind Affinity Blood Filter in the reduction of pathogen load from the blood in septic patients with suspected, life-threatening bloodstream…

Protocol ALL-11:Treatment study protocol of the Dutch Childhood Oncology Group for children and adolescents (1-19 year) with newly diagnosed acute lymphoblastic leukemia

1. To improve the overall outcome as compared to the previous protocols of the DCOG, especially ALL-9 and ALL-10.This is aimed for by decreasing therapy for part of the patients (TEL/AML1, Down syndrome, PPR only), increasing therapy for IKZF1…

A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) vs Placebo in Subjects with Hepatocellular Carcinoma Who Have Received Prior Sorafenib

The objective of this study is to evaluate the effect of cabozantinib compared with placebo on overall survival in subjects with advanced HCC previously treated with sorafenib.

The relationship between contrast media volume and tube voltage in computed tomography of the liver, for optimal enhancement based on total body weight: A randomized controlled trial. [COMpLEx trial]

The aim of present study is to investigate if adapting the dosing factor based on TBW and therefore the CM volume to the tube voltage used, results in a more homogeneous liver enhancement. We hope to find a more homogeneous enhancement between…

Goal-directed versus restricted fluid management during major hepatic surgery; a double blind randomized controlled pilot trial

The aim of this double-blinded pilot randomized controlled trial (RCT) is to compare the effects of a conventional LCVP vs. a GDFT protocol in open liver surgery on surgical and anesthesiological conditions and its relation to outcome. Primary…

The DRAGON-PLC trial: An international multicentre randomised controlled trial to compare combined Portal and Hepatic Vein Embolisation (PVE/HVE) with PVE alone in patients with primary liver cancers.

To evaluate the effect of combined PVE/HVE compared to PVE alone on resectability and overall survival in patients with primary liver cancers.