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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…

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.…

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.

Evaluation of Sorafenib in combination with local micro-therapy guided by Gd-EOB-DTPA enhanced MRI in patients with inoperable hepatocellular carcinoma

Treatment strategy in early HCC aims at the local removal of the tumor and represents a potentially curative treatment option (resection, liver transplantation, PEI, RFA, BT). Patients in intermediate and advanced stage of HCC receive treatment with…

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…

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.…

GRACE (Genomics to combat Resistance against Antibiotics in Community-acquired LRTI in Europe).Workpackage 10: Antibiotic Trial One

The aim is to understand which individuals benefit from antibiotics.

Self-reported influenza-like symptoms among elderly

Primary Objective: • To determine the efficacy of 13vPnC in preventing a first episode of self-reported ILI.Secondary Objectives: • To determine the efficacy of 13vPnC in preventing a first episode of self-reported LRTI.• To determine the incidence…

Exposure of human volunteers to live malaria sporozoites under chloroquine prophylaxis

Primary objective (parasitological): To induce protection against malaria by exposure to infectious mosquito bites under chloroquine prophylaxis. Secondary objectives (immunological): 1. To induce an effective immune response against natural malaria…

The Impact of glutamine suppletion on outcome in patients undergoing high-risk cardiothoracic surgery.

Aim of the study is to assess the effects of supplemental parenteral L-alanyl-L-glutamine treatment on infectious, cardiac, cerebral, pulmonary and gastro-intestinal morbidity during the ICU- (Intensive Care Unit) and hospital stay in patients after…

Infection prevention and immune modulation by bacterial lysates in patients with asthma: gaining insight into the mechanism of an old therapy

To diminish the number of asthma exacerbations with the regular use of a bacterial lysate.

A randomized double-blind placebo-controlled phase I study on the safety, tolerability and pharmacokinetics/-dynamics of escalating single intravenous doses of ADRECIZUMAB (HAM8101) in healthy male subjects during experimental endotoxemia.

Primary Objective:1. To assess the safety and tolerability of single escalating doses of Adrecizumab in healthy male volunteers during experimental endotoxemia.Secondary Objectives:2. To determine the pharmacokinetics of single escalating doses of…

Xylitol/saline nasal irrigations in patients with CRS without polyps, a multicenter double-blind, randomized study in 66 subjects with CRS without polyps

In this study we will compare the therapeutic value of saline only versus xylitol/saline nasal irrigations in patients with CRS without nasal polyposis (CRSsNP). We will investigate several parameters by means of 2 different questionnaires and…

A randomized, placebo-controlled, double-blind, multi-center Phase 2/3 trial to assess efficacy and safety of octreotide subcutaneous depot (CAM2029) in patients with symptomatic polycystic liver disease

This study has been transitioned to CTIS with ID 2023-505313-24-00 check the CTIS register for the current data. To evaluate the treatment effect of CAM2029 compared to placebo on liver volume in patients with polycystic liver disease (PLD)

A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants with Advanced and/or Unresectable Biliary Tract Carcinoma (KEYNOTE 966)

This study has been transitioned to CTIS with ID 2023-506657-38-00 check the CTIS register for the current data. To compare pembrolizumab plus gemcitabine plus cisplatin to placebo plus gemcitabine plus cisplatin with respect to overall survival (OS…

A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) with Pembrolizumab (MK-3475) in Combination with Transarterial Chemoembolization (TACE) Versus TACE in Participants with Incurable/Non-metastatic Hepatocellular Carcinoma (LEAP-012)

To compare pembrolizumab plus lenvatinib in combination with TACE versus placebo plus TACE with regard to progression-free survival (PFS) per RECIST 1.1 assessed by blinded, independent central review (BICR)

Study of EMF Neutrophil Activation effects phase 1

To show that this EMF exposure activates neutrophils in a group of subjects with diversity in age and gender.