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Investigation of DNA medication passport for antidepressants in primary care.

Investigate the effect of having CYP2C19 and CYP2D6 genotypes at start of antidepressant therapy and it’s cost-effectiveness in the primary care setting.

Heart rate registration in neonates using a PPG-integrated cap

Primary Objective: To assess the agreement between the heart rate assessed with a dedicated cap with integrated PPG-leads and standard ECG monitoring using regular neonatal thoracic electrodes as reference technique.Secondary objectives:Does…

Blink reflex changes after GON-injection in cluster headache: Clinical and pathophysiological implications.

To investigate if the GON-injection affects trigeminal threshold and transmission using the R2 component of the blink reflex.

The treatment of venous thromboembolism with edoxaban in patients with cirrhosis, a pharmacokinetic study.

To assess the safety and effect of edoxaban in Chil-Pugh B cirrhosis.

DIStal gastriC bypass Outcome in Revision SurgEry after roux-en-y gastric bypass

The aim of this study is to investigate the effect of two distalisation techniques of a gastric bypass in revisional surgery with standardised limb lengths in total weight loss (TWL) and the need for treatment for protein calorie malnutrition (PCM…

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Glioblastoma, Optimizing Logistics and Dose (GOLD).

To test whether extremely hypofractionated radiotherapy (6 x 6 Gy) is non-inferior to standard radiotherapy (30 x 2 Gy) in terms of overall survival in patients with newly diagnosed GBM. Secondary objectives are to establish and compare health…

First-in-human Phase I dose escalation study assessing safety, tolerability and preliminary efficacy of immunomodulatory nanoparticles

The primary objectives of this trial are:- To determine the safety and tolerability of increasing doses of PRECIOUS-01 after intravenous (i.v.) administration in subjects with solid tumors;- To assess the effect of increasing doses of PRECIOUS-01 on…

A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Single Agent Belantamab Mafodotin Compared to Pomalidomide plus Low-dose Dexamethasone (pom/dex) in Participants with Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM 3)

This study has been transitioned to CTIS with ID 2023-508962-14-00 check the CTIS register for the current data. Primary objective:To compare the efficacy with belantamab mafodotin vs pomalidomide plus low dose dexamethasone (pom/dex) in…

Sustained employability in cancer patients and their partners (STEPS)

(1) To evaluate the (cost-)effectiveness of an individual rehabilitation program on RTW and continuation of work in cancer patients with an employment contract, compared to care as usual (CAU). In addition, we will investigate the effect of the…

Neo-adjuvant nivolumab or nivolumab with ipilimumab in advanced cutaneous squamous cell carcinoma patients prior to standard of care surgery; the MATISSE trial

Herewith, we present a research protocol for a phase II trial that allows us to examine the efficacy (histopathological response rate) of ICI in the form of nivolumab or nivolumab plus ipilimumab prior to SOC in patients with resectable stage III-…

A prospective Phase I/IIa, open-label, multicenter trial to evaluate the safety and efficacy of oNKord®, an off-the-shelf, ex vivo-cultured allogeneic NK cell preparation, in subjects with acute myeloid leukemia who are in morphologic complete remission with measurable residual disease and who are currently not proceeding to allogeneic hematopoietic stem cell transplantation.

Primary ObjectivesThe primary objectives are:• The primary safety objective is to evaluate the safety and tolerability of the infusion of up to three doses of oNKord®• The primary efficacy objective is to assess the cumulative incidence of MRD…

AN OPEN-LABEL, PHASE I STUDY OF NEO-PTC-01 IN PATIENTS WITH ADVANCED OR METASTATIC MELANOMA

This study has been transitioned to CTIS with ID 2023-508524-35-00 check the CTIS register for the current data. The primary objective of this study are 1) to evaluate the safety and determine the highest tolerable dose of NEO-PTC-01 in patients…

Tiratricol treatment of children with Monocarboxylate Transporter 8 deficiency: Triac Trial II

This study has been transitioned to CTIS with ID 2024-516123-13-00 check the CTIS register for the current data. Part I:Primary Objective: Evaluate the effects of tiratricol on neurodevelopment in young MCT8 deficiency patients, as measured by the…

SURGERY FOR ADENOCARCINOMA OF THE GASTROESOPHAGEAL JUNCTION (GEJ) TYPE II: TRANSTHORACIC ESOPHAGECTOMY VS. TRANSHIATAL EXTENDED GASTRECTOMY (CARDIA trial)

The aim of the study is to compare transthoracic esophagectomy versus transhiatal extended gastrectomy in patients with GEJ type II tumors. It is hypothesized that esophagectomy allows for a higher rate of radical resections and a more complete…

Dose reduction of the new generation biologics (IL17 and IL23 inhibitors) in psoriasis: A pragmatic, multicentre, randomized, controlled, non-inferiority study - BeNeBio study

The primary goal is to investigate whether controlled dose reduction of IL17 or IL23 inhibiting biologics is not inferior compared to usual care. This is measured by comparing the proportion of long-term disease flares between the two groups (dose…

Lutetium-177-PSMA in Oligo-metastatic Hormone Sensitive Prostate Cancer.

This study has been transitioned to CTIS with ID 2023-509881-39-00 check the CTIS register for the current data. The aim of this study is to evaluate the difference in the fraction of patients that have disease progression within 6 months after…

A randomized, placebo-controlled, double-blind trial evaluating the efficacy, tolerability and safety of ESO-101 in adult patients with active eosinophilic esophagitis

To evaluate the efficacy based on the histological response

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk For or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene

This study has been transitioned to CTIS with ID 2023-506873-36-00 check the CTIS register for the current data. The primary objective of this study is: Part 1: To evaluate the efficacy of AL001 compared with placebo as measured by CDR® plus NACC…

An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475
(Pembrolizumab) in Children and Young Adults with Newly Diagnosed Classical Hodgkin
Lymphoma with Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE
667).

This study has been transitioned to CTIS with ID 2023-504821-38-00 check the CTIS register for the current data. Goal of this study is to determine the optimal balance between maintaining high rates of OS in this group and avoiding the long-term…