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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.

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.…

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.

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…

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…

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.

A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY OF TIVANTINIB (ARQ 197) IN SUBJECTS WITH MET DIAGNOSTIC-HIGH INOPERABLE HEPATOCELLULAR CARCINOMA (HCC) TREATED WITH ONE PRIOR SYSTEMIC THERAPY

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.

Phase I, randomized, parallel group, placebo control, unicentric, interventional study to assess the effect of expanded human allogeneic adipose-derived mesenchymal adult stem cells on the human response to lipopolysaccharide in human volunteers

To investigate the effect of expanded adipose-derived allogeneic adult stem cells (eASCs) on the inflammatory response to intravenous LPS in humans.

Regenerative surgical treatment of peri-implantosseous defects - a multicenter randomized prospective clinical study

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…

An Open-label, Randomized Phase 3 Study of the Efficacy and Tolerability of Linifanib (ABT-869) versus Sorafenib in Subjects with Advanced Hepatocellular Carcinoma (HCC)

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…

OASIS: A Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients with Severe Sepsis

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…

Retrograde in situ hypothermic perfusion of the liver during right hemihepatectomy

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.

The effects of immunostimulation with GM-CSF or IFN-γ on immunoparalysis following
human endotoxemia.
A parallel randomised double-blind placebo-controlled study

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…

Dexamethasone infusion in community-acquired pneumonia

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…

A randomized, double-blind, placebo-controlled PK/PD guided, phase I study in healthy volunteers given escalating, single intravenous doses of NI-0101 in the absence or presence of a systemic LPS challenge.

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…

A Multicenter, Randomized, Double-Blind, Phase 3 Study of Ramucirumab (IMC-1121B) Drug Product and Best Supportive Care (BSC) Versus Placebo and BSC as Second-Line Treatment in Patients With Hepatocellular Carcinoma Following First-Line Therapy With Sorafenib

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.…

A Phase I open label/ Phase II randomized, double-blind, multicenter study investigating the combination of RAD001 and sorafenib (Nexavar®) in patients with advanced hepatocellular carcinoma

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…

Effectiveness of adenoidectomy in children with recurrent upper respiratory tract infections

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…