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Drug-COated Balloon Coronary Angioplasty versus Stenting for Treatment of Disease Adjacent to a Chronic Total Occlusion - The Co-CTO Trial.

The aim of the study is to investigate the value of DCB treatment in the residual disease of the coronary artery after successful recanalization and stenting of the actual CTO body as compared with complete stenting in a randomized fashion.

EEG controlled triage in the ambulance for acute ischemic stroke

To determine the diagnostic accuracy of dry electrode cap EEG for diagnosis of LVO-a, when performed by paramedics in the ambulance in patients with a suspected AIS.

Positive end-expiratory pressure levels during resuscitation of preterm infants at birth

The specific trial aim is to establish whether the use of a high, dynamic 8-12 cmH2O PEEP level strategy to support the lung during stabilisation at birth, compared with a static 5-6 cmH2O PEEP level strategy, increases the rate of survival without…

Chronotherapy in Inflammatory Arthritis (ChronIA trial): a randomized controlled trial comparing the effectiveness of morning and evening dosing of tofacitinib extended-release

This study has been transitioned to CTIS with ID 2024-517865-17-00 check the CTIS register for the current data. We hypothesize that the timing of treatment in IA, also known as chronotherapy, matters and that the efficacy of tofacitinib XR depends…

A 3-Part, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate Safety and Efficacy of Avapritinib (BLU-285), a Selective KIT Mutation-Targeted Tyrosine Kinase Inhibitor, in Indolent and Smoldering Systemic Mastocytosis with Symptoms Inadequately Controlled with Standard Therapy

This study has been transitioned to CTIS with ID 2024-512585-34-00 check the CTIS register for the current data. Primary: Part 1 • To determine the RP2D of avapritinib in patients with ISM for use in Part 2 and Part 3 of the study.Part 2 • To…

An Open-Label, Multicenter, Phase 1/2 Trial of GEN3014 (HexaBody®-CD38) in Relapsed or Refractory Multiple Myeloma and Other Hematologic Malignancies

Dose escalation phase:Primary• Determine the RP2D and if reached, the MTD of GEN3014• Evaluate the safety and tolerability of GEN3014 Secondary:• Characterize the PK properties of GEN3014• Characterize the pharmacodynamic properties of GEN3014•…

A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects with Moderate to Severe Atopic Dermatitis

This study has been transitioned to CTIS with ID 2022-502936-38-00 check the CTIS register for the current data. The objective of the study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult subjects with…

4D-IRECT Pilot Trial (4 Dimensional - Impairment of posttraumatic forearm Rotation Evaluated with Computed Tomography)

First, to develop a 4D computer-assisted diagnostic method for estimating the cause of posttraumatic impairment of the forearm. This method is intended to allow differentiation of motion patterns reflecting mutual impingement of radius and ulna from…

Pilot study of FAPI PET/CT for locoregional (re)staging of lymph nodes in colorectal carcinoma

To describe the accuracy of FAPI PET/CT in the detection of regional lymph node metastases in patients with colorectal cancer in comparison with standard diagnostic imaging and (in operated patients) histopathology, aiming to provide early evidence…

Transdiagnostic processes in (comorbid) anxiety disorder(s), post-traumatic stress disorder, obsessive-compulsive disorder and depression (TAPOD)

This project aims to 1) investigate transdiagnostic processes in patients with anxiety disorders, PTSD, OCD and depressive disorders with and without comorbidity, 2) relate these processes to severity of symptoms, treatment progress, and relapse.…

The Impact of Telemonitoring on correct drug Use, complications and quality of life among patients with Multiple Myeloma (MM);(ITUMM)

The main objective of the project is to study difference between compliance by pill count after 3 months by newly diagnosed multiple myeloma (NDMM) patients with an innovative e-coach, in order to improve treatment compliance by the intervention…

Investigating the immune response to COVID-19 Vaccination in Lung Transplantation patients (COVALENT study)

To investigate the humoral and cellular immune response, and the development of immunological memory to the COVID-19 vaccination in lung transplantation patients. To clarify firstly if immunity develops in these patients and secondly, if the immune…

Leiden Thrombosis Recurrence Risk Prevention: Tailored treatment after a first venous thromboembolism: (L-TRRiP study)

To determine which patients, individually classified for VTE ánd bleeding risk, will benefit from prolonged anticoagulant treatment without being unnecessarily exposed to its risks.

Evaluating the effects of acute LPS exposure on Energy metabolism and Substrate utilization as well as markers reflecting lipid and glucose metabolism: The LES trial

The main objective for the current project is to investigate the effect of acute systemic inflammation - induced by LPS exposure - on energy metabolism, measured as resting metabolic rate (RMR), in apparently healthy volunteers.

A randomised controlled trial investigating the effect of virtual reality on labour analgesia use

The aim of this study is to investigate whether VR will decrease the request for labour analgesia. Primary outcome measure:* Request for labour analgesiaSecondary outcome measures:* Patient tolerability, feasibility and satisfaction of VR use (VR-…

Personalized Use of Resources study

This study has been transitioned to CTIS with ID 2024-515542-16-02 check the CTIS register for the current data. Primary objective:The objective is to evaluate if the LCPT dose can be reduced in comparison with tacrolimus-ER and still achieve…

The efficacy of the addition of TRAstuzumab and Pertuzumab to neoadjuvant chemoradiation: a randomized multi-center study in resectable HER2 overexpressing adenocarcinoma of the esophagus or gastroesophageal junction. The TRAP-2 study.

This study has been transitioned to CTIS with ID 2024-513797-22-00 check the CTIS register for the current data. In the so-called adenocarcinoma of the esophagus, the HER2 receptor can be detected in about 15% of the tumors. Based on the phase II…

The Impact of Early Delirium Detection with DeltaScan on Management of Underlying Delirium Causes in Critically Ill Patients. A randomized controlled trial.

This randomized controlled trial aims to study the effect of implementation of EEG based encephalopathy detection (DeltaScan, Prolira, Utrecht, The Netherlands, hereafter: DeltaScan) on relevant clinical endpoints (ICU length of stay) as well as the…

A nationwide multicentre, open-label study of six months avelumab maintenance treatment in patients with locally advanced or metastatic urothelial cancer whose disease did not progress after at least 4 cycles of first-line platinum-containing chemotherapy and the opportunity to re-treat

This study has been transitioned to CTIS with ID 2024-512975-11-01 check the CTIS register for the current data. To demonstrate benefit of maintenance treatment with avelumab for a maximum of six months avelumab in increasing overall survival (OS)…

The effects of intra uterine exposure to Tumor Necrosis Factor alpha inhibitors in infants on the development of the immune system

Primary ObjectiveIn order to assess the effects of anti TNFα on the development of adaptive and innate immunity, children exposed to anti TNFα (with or without other immunosuppressive drugs) will be compared to children exposed to immunosuppressive…