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THE EFFECT OF EXTERNAL LEG COMPRESSION ON THE REDUCTION OF FLUID DEMAND IN MECHANICALLY VENTILATED PATIENTS WITH SEVERE SEPSIS OR SEPTIC SHOCK

To study the effect of ELC during mechanical ventilation (MV) on fluid balance in severe sepsis or septic shock.

Holmium-166-radioembolization in patients with unresectable hepatocellular carcinoma; a multi-center, interventional, non-randomized, non-comparative, open label, early phase II study: HEPAR Primary

Primary objective:To establish the safety and toxicity profile of 166Ho-RE in patients with hepatocellular carcinoma. Secondary objectives:* To evaluate efficacy of 166Ho-RE in hepatocellular carcinoma without curative treatment options in a non-…

The ORANGE II PLUS - Trial: An international multicentre randomized controlled trial of open versus laparoscopic liver surgery (hemihepatectomy and postero-superior liver segment resection).

Hypotheses: - For patients undergoing a laparoscopic left or right hemihepatectomy (with or without the need for one additional hepatic wedge resection or metastasectomy), time to functional recovery is reduced by 2 days in comparison with patients…

COLDFIRE-2 study: Colorectal metastatic liver disease: efficacy of irreversible electroporation (IRE) - a phase II clinical trial

The primary objective of this project is to evaluate the primary and secondary technique effectiveness of IRE for centrally located colorectal liver metastases that are neither amenable for resection nor for other local ablation methods due to the…

Neo-adjuvant chemotherapy followed by surgery versus surgery alone in high-risk patients with resectable colorectal liver metastases ;The CHARISMA randomized multicenter clinical trial

The primary study objective is to compare the efficacy, as assessed by overall survival, of surgery and neo-adjuvant chemotherapy to surgery alone in patients with resectable liver metastases of colorectal cancer and a high clinical risk score.…

Phase II trial with melphalan for percutaneous chemosaturation (CS-PHP-Mephalan) in treating unresectable liver metastases of uveal melanoma

Primary objective • To determine the overall response rate of two PHP with an at least 6 week interval and 3 mg/kg melphalan in irresectable liver metastases patients. • To determine the percentage of patients qualifying for resection. Secondary…

Adjuvant hepatic Holmium-166-radioembolization in patients with unresectable liver metastases of neuroendocrine origin, who have been treated with Lutetium-177-dotatate; a single center, interventional, non-randomized, non-comparative, open label, phase II study

Primary objectives:* To evaluate efficacy of adjuvant 166Ho-radioembolization (166Ho-RE) after systemic 177Lu-dotatate in a non-comparative phase II study Secondary objectives:* To establish the safety and toxicity profile of adjuvant 166Ho-RE after…

A treatment algorithm for Hepatic Angiomyolipomas: a long-term follow-up study and a systematic review

The aim of this study is to get insight into the long-term clinical course of HAML*s in order to develop a treatment algorithm. Primary Objective: The main study parameters are recurrence, growth or development of new HAML tumors.

A Phase 3 Randomized, Placebo-Controlled, Blinded Study to Investigate the Safety and Efficacy of a Topical Gentamicin-Collagen Sponge in Combination with Systemic Antibiotic Therapy in Diabetic Patients with an Infected Foot Ulcer

Primary Objective:To determine the effect of the Topical Gentamicin-Collagen Sponge (gentamicin-sponge) in combination with systemic antibiotic therapy compared to placebo-sponge and no-sponge, both in combination with systemic antibiotic therapy on…

Transarterial Chemoembolization with Drug-Eluting Beads (standard arm) versus Stereotactic Body Radiation Therapy (experimental arm) for hepatocellular carcinoma:
A multicenter randomized phase II trial *The TRENDY trial*

To assess the time to progression after TACE-DEB and after SBRT in a comparable population of patients diagnosed with HCC.

Cone-beam CT guided Stereotactic Radiation Therapy for Locally Advanced and Locally Recurrent Pancreatic Cancer

To determine safety and technical feasibility of stereotactic radiotherapy for locally advanced and locally recurrent pancreatic carcinoma.

A Randomized, Double-Blind, Placebo-Controlled, Four-Arm, Parallel-Group, Proof of Concept, and Dose-Finding Adaptive Phase 2a/2b Study to Investigate the Safety, Tolerability and Efficacy and Effect on Quality of Life of Human Recombinant Alkaline Phosphatase in the Treatment of Patients With Sepsis-Associated Acute Kidney Injury.

The primary objectives of the study are as follows:• To investigate the effect of recAP on renal function and related clinical parameters in patients with SA-AKI.• To determine the therapeutic dose(s) of recAP to support the pivotal Phase 3 program.…

MOSAIC-2 Study: MOdel to Study upper Airway Immunity upon Cholera vaccination

To investigate whether raw milk, pasteurized milk or ultra-heat treated (UHT) milk is able to enhance the systemic immune response as induced by oral cholera vaccination, in comparison to regular vaccination. Oral vaccination can also induce an…

Population pharmacokinetics and pharmacodynamics of sorafenib in hepatocellular carcinoma patients with Child Pugh B liver cirrhosis

1. To optimize sorafenib treatment in patients with HCC and CP-B liver cirrhosis by exploration of sorafenib exposure, its variability and predictive factors .Secondary:2. To assess the relation between sorafenib exposure and both toxicity and…

Pilot-study: Investigation of the safety of irreversible electroporation (IRE) as novel treatment for colorectal liver metastases - a phase I clinical study

The primary objective of this study is to evaluate the safety in terms of complication rate of IRE in the treatment of colorectal liver metastasis/es <3,5 cm in patients undergoing surgical resection (metastatectomy, segmental liver resection…

Transarterial RAdioembolization versus ChemoEmbolization for the treatment of HCC:
a multicenter randomized controlled trial

The overall goal of this RCT is to compare the efficacy of 90Y-RE to TACE-DEB, for patients with intermediate stage HCC. Time to progression, overall survival, tumor response, adverse events, treatment related effect on total liver function, quality…

Irreversible Electroporation for treatment of unresectable, locally advanced pancreatic cancer in the Leiden University Medical Centre: a phase I/II study.

Main objectiveTo investigate feasibility and safety of tumor ablation using IRE in patients with irresectable locally advanced pancreatic head carcinomas.Secondary objective(s)To investigate tumor downstaging efficacy, pain perception and hospital…

External beam radiotherapy for unresectable hepatocellular carcinoma. A multicenter phase I/II trial.

Trial objectivesThe objective of the phase I is to assess the feasibility and safety of radiotherapy (RT) in hepatocellularcarcinoma (HCC).The objective of the phase II is to assess the efficacy and safety of RT in HCC.Additional research…

A multicenter, open label, phase I / II study to evaluate safety, pharmacokinetics and efficacy of BIBF 1120 in comparison with oral sorafenib for advanced hepatocellular carcinoma patients.

To evaluate the efficacy and safety of BIBF 1120 in HCC patients without prior systemic treatment as compared to Sorafenib.

Radioactive holmium microspheres for the treatment of patients with unresectable liver metastases; a single center, interventional, non-randomized, phase II efficacy (HEPAR II) trial.

Primary objective:To determine target lesions tumour response.Secondary objectives:* To determine overall tumour response.* To determine the liver specific progression-free survival.* To determine non-liver specific progression-free survival.* To…