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Efficacy of Pectoral Nerve (PECS II) Block with Liposomal Bupivacaine versus Levobupivacaine for Patients undergoing a Mastectomy: A Prospective Randomized Controlled Trial.

This study has been transitioned to CTIS with ID 2024-515183-30-00 check the CTIS register for the current data. The aim of this prospective randomized, double blind study is to evaluate the analgesic effects of pre-operative PECS II-block with (…

Hollands-midden Acute Regional Triage - cardiology (HART-c): point-of-care high-sensitivity cardiac Troponin I study

To determine the effectiveness of the HEART (History, Electrocardiogram (ECG), Age, Risk factors, Troponin) score with POC hs-cTnI testing by ambulance nurses in safely ruling out ACS and increasing the number of patients left at home after…

Dupuytren*s disease Evaluation of Preventative or Adjuvant Radiation Therapy

Primary objective: To show a meaningful reduction in progression of DD with the application of radiotherapy both in the early stages as well as following local treatment in the later stages.Secondary objectives: 1. Report physician graded toxicity…

An Open-Label, 2-Arm, Multicenter, Randomized Phase 3 Study To Evaluate The Efficacy And Safety of Elranatamab (PF-06863135) + Daratumumab + Lenalidomide Versus Daratumumab + Lenalidomide + Dexamethasone in Transplant-Ineligible Participants With Newly-Diagnosed Multiple Myeloma

This study has been transitioned to CTIS with ID 2024-514139-50-00 check the CTIS register for the current data. Part 1PrimaryTo assess dose limiting toxicities (DLTs) of EDR to select an RP3D for the combination to be used in Part 2 of this study.…

Randomized Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF): The CORCINCH-HF
Study

The objective of this study is to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with symptomaticheart failure with reduced ejection fraction (HFrEF).

Can molecular imaging predict outcome to firstline endocrine treatment ± CDK 4/6 inhibition in
advanced ER+ breast cancer?

Based on the data as described above, we hypothesize that the FES-PET heterogeneity score can predict progression free survival (PFS) in individual patients prior to start of 1st line endocrine treatment and CDK 4/6 inhibition in ER+ advanced breast…

Peroperative Administration of Tranexamic acid in Roux-en-Y and one-anastomosis gastric bypass to reduce hemorrhage rates (PATRY study): a randomized controlled trial

This study has been transitioned to CTIS with ID 2024-513570-22-00 check the CTIS register for the current data. This trial aims to investigate whether peroperative administration of TXA reduces haemorrhage rates in patients who undergo metabolic…

Phase 3, Multicenter, Randomized, Double-Masked, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Tinlarebant in the Treatment ofStargardt Disease in Adolescent Subjects

This study has been transitioned to CTIS with ID 2024-513483-26-00 check the CTIS register for the current data. To assesses the efficacy of Tinlarebant in slowing the rate of growth of atrophic lesion(s) in adolescent subjects with STGD1.

CHIP-AML22 Master protocol: An open label complex clinical trial in newly diagnosed pediatric de novo AML patients - a study by the NOPHO-DBSHIP consortium

This study has been transitioned to CTIS with ID 2023-504999-25-00 check the CTIS register for the current data. To investigate wether the treatment of children and adolescents with AML can be improvedby means of:1) improved risk-group adapted…

International cooperative Phase III trial of the HIT-HGG study group for the treatment of high grade glioma, diffuse intrinsic pontine glioma, and gliomatosis cerebri in children and adolescents < 18 years.

Primary objective:-To confirm that the Event-Free Survival (EFS) in patients &gt;= 3 years of age with WHO grade IV/CNS WHO grade 4 and WHO grade III/CNS WHOgrade 3 diffuse high grade gliomas as well as diffuse high grade gliomas without a…

A Phase 3, Randomized, International Multicenter Trial of DAY101 Monotherapy Versus Standard of Care Chemotherapy in Patients with Pediatric Low-Grade Glioma Harboring an Activating RAF Alteration Requiring First-Line Systemic Therapy

This study has been transitioned to CTIS with ID 2024-510742-13-00 check the CTIS register for the current data. The primary objective is to compare the objective response rate (ORR) assessed per Response Assessment in Neuro Oncology for low-grade…

COLLISION RELAPSE trial - Recurrent colorectal liver metastases: repeat local treatment +/- neoadjuvant systemic therapy - a phase III prospective randomized controlled trial

This study has been transitioned to CTIS with ID 2024-515341-41-01 check the CTIS register for the current data. The primary objective is to demonstrate superiority of neoadjuvant systemic therapy followed by repeat local treatment as compared to…

A multicentre randomised open-label phase III study of stereotactic radiosurgery, in addition to standard systemic therapy for patients with metastatic melanoma or newly diagnosed metastatic NSCLC and asymptomatic or oligosymptomatic brain metastases.

The primary objective of the study is to assess the efficacy in terms of CNS-specific PFS ofthe combination of standard systemic treatment plus SRS versus standard systemictreatment alone in patients with newly diagnosed and untreated (except for…

An Operationally Seamless, Randomized Phase 2/3 Study Consisting of a Phase 2 Single Blind, Dose-Evaluation Phase and a Phase 3 Double-Blind, Placebo-controlled Phase to Assess the Efficacy and Safety of Setrusumab in Subjects with Osteogenesis Imperfecta

This study has been transitioned to CTIS with ID 2024-510919-29-00 check the CTIS register for the current data. OBJECTIVES - Phase 2 (not to be conducted in NL):Phase 2 Primary Objective:- Identify a setrusumab dosing strategy in subjects with OI…

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Mitapivat in Pediatric Subjects With Pyruvate Kinase Deficiency Who Are Not Regularly Transfused, Followed by a 5-Year Open-label Extension Period

This study has been transitioned to CTIS with ID 2024-515025-28-00 check the CTIS register for the current data. To determine the efficacy of treatment with mitapivat compared with placebo, as assessed by the increase in Hb concentrations in…

Excitability Modeling And Correction of Hyperactive Brain Networks in Alzheimer*s disease

The overall objective is to perform simulations in a computer model of the human brain to map out the optimal parameters for non-invasive brain stimulation in AD. Simulations will be performed in both general and personalised models, the latter…

Effectiveness of focal therapy in men with prostate cancer (ENFORCE)

We hypothesize that a significant proportion of the patients will benefit more from focal therapy as compared to usual care in terms of morbidity and quality of life, without compromising oncological effectiveness. Primary objective: To study the…

The cardiovascular safety of efficacy cagrilintide 2.4 mg s.c. in combination with semaglutide 2.4 mg s.c. (CagriSema 2.4 mg/2.4 mg s.c.) once-weekly in participants established cardiovascular disease

This study has been transitioned to CTIS with ID 2023-506924-94-00 check the CTIS register for the current data. Primary: to confirm non-inferiority of CagriSema 2.4 mg/2.4 mg versus placebo with respect to time to first major adverse cardiovascular…

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel, Multicenter Study to Evaluate the Safety and Efficacy of ALXN1720 in Adults with Generalized Myasthenia Gravis.

This study has been transitioned to CTIS with ID 2023-508284-77-00 check the CTIS register for the current data. The purpose of this study is to evaluate the safety and efficacy of ALXN1720 for the treatment of gMG in adults with autoantibodies…

An Open-label Randomized Phase 3 Study of Tucatinib in Combination with Trastuzumab and mFOLFOX6 versus mFOLFOX6 given with or without either Cetuximab or Bevacizumabas First-line Treatment for Subjects with HER2+Metastatic Colorectal Cancer

To evaluate the efficacy and safety of tucatinib in combination with trastuzumab and mFOLFOX6 in comparison to mFOLFOX6 given with or without either bevacizumab or cetuximab as first-line (1L) treatment in adults with HER2 positive (HER2+)…