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A double-blind, randomized-withdrawal, placebo-controlled study to evaluate the efficacy and safety of human plasma-derived C1-esterase inhibitor as add-on to standard of care for the treatment of refractory antibody mediated rejection in adult renal transplant recipients

The primary objective of the study is to evaluate the efficacy of C1-INH in the treatment of refractory AMR in renal allograft recipients.The secondary objectives of the study are:1. To further evaluate the efficacy of C1-INH in the treatment of…

Influence of saltintake on Microcirculation and immune System

In this study we aim to elucidate effects of dietary sodium intake on:1. Body weight and blood pressure2. Microcirculation by studying the capillary network during high and low sodium conditions.3. Adaptive and innate immune system by studying…

A Phase 3, Randomized, Open-Label, Multicenter Study, to Compare
T-Guard to Ruxolitinib for the Treatment of Patients with Grade III or IV Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD)

To assess the rate of complete response (CR) in Grades III and IV SR-aGVHD participants on Day 28 postrandomization.

Explorative study to the effect of BCG booster methods on the induction of trained innate immunity

The objective of the study is to determine the effect of BCG revaccination and high dose BCG vaccination on the induction and course of innate immune memory.

PILOT STUDY: WEB-BASED TREATMENT OF SEVERE FATIGUE AMONG ADOLESCENT PATIENTS WITH AN IMMUNE DYSREGULATION DISORDER: A SINGLE-CASE EXPERIMENTAL DESIGN WITH MULTIPLE MEASUREMENTS.

1. To investigate the feasibility of web-based cognitive CBT among severely fatigued adolescent patients with an immune dysregulation disorder, and 2. To estimate intervention effects on reducing fatigue, associated chronic pain and fatigue related…

Randomized, double-blind, placebo-controlled study to characterize the immune response after repeated KLH immunizations in healthy volunteers

Primary To characterize systemic and local KLH-specific B and T cell responses by repeated KLH immunizationsSecondaryTo characterize the molecular basis of the KLH-driven skin response (acute versus delayed response, Th1 versus Th2 response)To…

A phase 1, double-blind, randomised, placebo-controlled multiple dose study investigating the immunopharmacology of EDP1815 with multiple formulations

* To evaluate the effect of EDP1815 on the systemic immune system.* To evaluate the safety and tolerability of EDP1815 in multiple formulations.

A phase 1, double-blind, randomised, placebo-controlled multiple dose study investigating the immunopharmacology of EDP1066 with multiple formulations

Primary* To evaluate the effect of EDP1066 in multiple formulations on the systemic immune system.Secondary* To evaluate the safety and tolerability of EDP1066 in multiple formulations.

Neutrophil viability in surgical patients and its relationship with neutrophil functionality

This study aims to further investigate neutrophil viability as marker for neutrophil cell dead in patients with a decreased leukocyte viability factor and investigate its impact on neutrophil functioning.

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…

Enhancing the BCG-induced trained immunity response by addition of bisphosphonate or MMR vaccine: a possible preventive approach against COVID-19 (BCG-PLUS)

To investigate the effect of bisphosphonates and the MMR vaccine on BCG-induced trained immunity as a possible preventive approach against COVID-19

Understanding colchicine resistance in Familial Mediterranean Fever; exploring pathophysiological mechanisms and therapeutic options

The primary objective is to identify what causes colchicine resistance in FMF. Additionally, we will try to identify potential interventions to overcome resistance

Deuterated water labelling of specialized T cell subsets

Primary Objective:1. Turnover rate of antigen-specific cells (group I)2. Turnover rate of functional T-cell subsets (group II)Secondary Objective(s):• Determining absolute numbers of antigen (poliovirus, measles, Hepatitis A and Hepatitis B)…

COBRA re-KAI study: COVID-19 vaccination in patients with reduced B-cell and T-cell immunity: response after re-vaccination of a kaleidoscopic group of hematological patients: what*s the impact?

To answer the following questions: 1. Who are the patients that need to be revaccinated?2. How many vaccinations are needed to restore SARS-CoV-2 immunity?3. Can the number of vaccinations needed to restore SARS-CoV-2 immunity be predicted?To answer…

Vaccinations in the Immunocompromised population: paramount and paradox.

The objective of this study is to determine the immune response after hepatitis A and pneumococcal vaccination in different groups of ICPs. The overarching aim of the study is to improve vaccine regimens and to optimize guideline recommendations…

Immunity to varicella-zoster virus in immunocompromised renal disease patients

More knowledge on immunity to VZV in these patient groups is necessary to be able to design preventive strategies to VZV infections in the future. To reach these goals, the proposed study is divided into two parts. The first part aims to determine…

Prevalence of clinical characteristics of patients with a (probable) Behçet*s syndrome in the Netherlands, a follow up cohort study.

Main objective is to collect longitudinal follow up data of all patients with (suspected) Behçet*s syndrome. In order to study prevalance and incidence of clinical disease manifestations.Secondary objectives: 1. What is the prevalence of various…

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo- And Active-Controlled Study Followed By A Placebo-Controlled Maintenance Period And Open-Label Follow-Up To Evaluate The Efficacy And Safety Of Certolizumab Pegol In Subjects With Moderate To Severe Chronic Plaque Psoriasis

(Protocol v1.0 25Jul2014 p.18) The primary objective of the study is to compare the efficacy of certolizumab pegol (CZP) administered subcutaneously at the doses of CZP 400mg every two weeks and CZP 200mg every two weeks after a loading dose of CZP…

Does a deregulated PI3K/Akt-pathway affect the immune system in children with Down syndrome?

1. To examine whether the PI3K-AKT pathway is overly activated in children with Down syndrome compared to healthy age-matched controls. 2. To determine the rate of exhaustion and the apoptosis of lymphocytes in children with DS. 3. To determine the…

T cells and innate lymphoid cells (ILCs) in cutaneous graft-versus-host disease

The overall aim of the study is to improve our understanding of the role of T cells and ILCs in cutaneous GvHD, to lay the foundation for the development of better therapies to treat cutaneous GvHD.1. T cells in GvHDThe dominant cell population in…