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Predicting efficacy of neuromodulation in epilepsy

We started to evaluated the feasibility of subcutaneous EEG electrodes in epilepsy patients undergoing VNS therapy in a pilot study. This part is currently finished.Currenrly, we are extending the cohort and aim to identify biomarkers to predict…

Faecal Metabolomics and Microbiota as Non-Invasive Biomarkers for Disease Activity and to Predict Treatment Response in Paediatric Inflammatory Bowel Disease

It is aimed to develop fecal microbiota-metabolomics based algorithms for diagnostics, monitoring and predicting therapy response in IBD which can be applied in daily clinical practice and to identify predictive factors for outcome and treatment…

Patient satisfaction with a new smart and cost-effective Insulin Patch Pump System in type 1 diabetes patients using CSII and CGM or Flash glucose monitoring system

To perform a patient satisfaction study on the Equil patch pump in T1DM patients that currently already use CSII in combination with CGM or Flash glucose monitoring.

A Phase 1 First-in-Human Study with ABBV-155 Alone and in Combination with Taxane Therapy in Adults with Relapsed and/or Refractory Tumors

This study has been transitioned to CTIS with ID 2024-513625-23-00 check the CTIS register for the current data. Primary objectives:•To determine the maximum-tolerated dose (MTD) and recommended Phase 2 dose (RPTD) of ABBV-155 administered as…

A Phase 2b Study to Evaluate the Safety and Efficacy of IMR-687 in Subjects with Sickle Cell Disease

* To evaluate the fetal hemoglobin (HbF) response to IMR-687 versus placebo * To evaluate the safety of IMR-687 versus placebo

An exploratory study of durvalumab (MEDI4736) uptake during concurrent chemoradiotherapy in stage III NSCLC patients using 89Zr-labeled durvalumab PET

Primary Objectives:* To study early (1 week after start of cCRT) and late changes (after finishing cCRT) in durvalumab (MEDI4736) uptake in tumor and metastatic lymph nodes during cCRT * To study early and late changes in durvalumab (MEDI4736)…

De-escalation of treatment for Papillary Thyroid Cancer followed by Active Surveillance - a pilot study

Primary Objective: The aim of this pilot study is to determine the willingness of patients to participate in a RCT regarding de-escalation of treatment of PTC and to observe adherence to this less aggressive approach. This will be accomplished by…

Setup and intra-fractional motion measurements using surface scanning in head and neck cancer patients

The aim of the study is to investigate the clinical feasibility of irradiation without a mask for head and neck cancer patients. Optical surface scanning will be used and the set-up accuracy, intra-fractional motion, patient friendliness, and…

Randomized, placebo-controlled, double blind, multi-centre Phase IIb study to evaluate the efficacy and safety of HepaStem in patients with acute on chronic liver failure (ACLF).

The primary objective is:to demonstrate the efficacy of 2 infusions (intravenous [i.v.]) of HepaStem at 1.0 million of cells/kg body weight (BW) (7 days apart) on the overall survival proportion at 90 days post first infusion.The secondary…

Prospective diagnosis of Covid-19 infection using exhaled breath analysis by electronic nose

Objective: The overall aim of this pilot study is to determine the diagnostic accuracy of exhaled breath analysis by eNose for the discrimination between patients and health care workers with and without Covid-19 at point of care.

A Phase IIIb, Randomized, Multicenter, Active-controlled, Parallelgroup, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine administered every two months from a Bictegravir/emtricitabine/tenofovir alfenamide Single Tablet Regimen in HIV-1 Infected Adults who are Virologically Suppressed

Primary:To demonstrate the non-inferior antiviral activity of CAB LA + RPV LA every two months compared to a BIK single tablet regimen administered once daily over 12 months in suppressed HIV-1 infected antiretroviral therapy (ART)-experienced…

A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active
Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety.

Main objective:To demonstrate superior efficacy with evobrutinib compared to Teriflunomide in terms of Annualized Relapse Rate (ARR) Secondary objectives:a.To demonstrate the efficacy of evobrutinib relative to that of Teriflunomide on disability…

Unraveling tumor response and resistance to combined chemotherapy and PD-L1 inhibition with minimal invasive techniques in patients with advanced NSCLC with targetable disease

The primary objective of this study is to identify biomarkers predictive for response to chemo-immunotherapy in patients with lungcancer with a known driver mutation.Secondary endpoints are overall survival; time to biological progression, defined…

Serial plaque changes predicting cardiovascular events

Evaluate the natural history of coronary artery disease and evaluate whether mid- to long-term plaque progression and changes measured with CCTA imaging can effectively predict CV events.

Pulmonary damage after hospitalization for acute COVID-19,
an exploratory prospective cohort study.

The primary aim of this study is to determine types and prevalence of residual pulmonary damage after hospital admission for acute COVID-19. In particular, we aim at determining the prevalence of clinically *silent* pulmonary perfusion abnormalities…

AN OPEN-LABEL, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ECULIZUMAB IN PEDIATRIC PATIENTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS

The primary objectiveTo evaluate the efficacy of eculizumab in the treatment of pediatric refractory generalized myasthenia gravis (gMG) based on change from Baseline in the Quantitative Myasthenia Gravis score for disease severity (QMG).The…

COntinuation Versus Interruption of Immunomodulating Drugs in case of an Infectious disease in immune mediated inflammatory disease (IMID) patients, with special attention for COVID-19

1) To assess the effect of continuation of IA treatment in IMID patients during an infection compared to temporary interruption of the IA treatment with regard to serious infection.2) to study the incidence and risk factors for infection in IMID…

Sleep and fatigue assessment in the home environment with digital technology

The objective is to find the most promising digital / objective sleep and fatigue parameters, which can be assessed with digital technologies in the home environment.

The rate of developing a biopsy-bases diagnosis of High-Grade Dysplasia or Esophageal Adenocarcinoma in patients with Barrett*s esophagus, after an extensive baseline evaluation with random biopsies and Wide Area Transepithelial Sample Esophageal brush combined with Computer Assisted 3-Dimensional Tissue Analysis (WATS3D): The WATS-EURO2 Pilot study;The WATS-EURO2 Pilot study

To assess the feasibility of our study logistics and infrastructure, sample processing and online study database.

Impact of COVID-19 on children and adolescents with autism spectrum disorder (ASD) and their families

Our goals are to investigate 1) the impact of COVID-19 on families with children with ASD, 2) the risk and protective factors of functioning and 3) care and information needs. Our results can inform clinical care, parents, and the government on how…