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A nationwide cohort study on benign liver tumors and cysts in the Netherlands

Benign liver tumors and cysts carry a significant burden on the quality of life in some cases. Apart from impairing symptoms, psychological burden might provide sufficient ground for surgical intervention. There is a variable approach to them…

Costs of Implant-supported Over-Dentures (IOD) can be halved using a digital workflow

Our goal is to manufacture a 3D-IOD which is designed digitally, and subsequently 3D-printed. Such 3D-IOD, can be made cheaper, faster and more patient friendly. To prove such a statement, patients should at least be even satisfied about their 3D-…

A prospective, multicenter, randomized, open-label, active-controlled, phase III study to compare efficacy and safety of masitinib to imatinib at 400 or 600 mg in treatment of patients with gastro-intestinal stromal tumour in first line medical treatment

Safety and efficacy objectives:The objective is to compare the safety and efficacy of masitinib at 6 of 7.5 mg/kg/day to imatinib at 400 or 600 mg, in patients with gastro-intestinal stromal tumour in first line medical treatment.

Short and long term effects of clinical DBT-PE for patients with severe posttraumatic stress disorder and co-morbid psychopathology

The current study aims to determine the effect of a 12-week residential DBT-PE program on a range of different outcomes, including the severity of PTSD, dissociation, personality disorders, and social functioning; The study also aims to predict…

Implantation of an auditory brainstem implant for the treatment of incapacitating unilateral tinnitus

To evaluate the efficacy of an ABI for the suppression of unilateral, intractable tinnitus and to establish the safety of the ABI for this new indication.

Randomized Controlled Trial of Laparoscopic Primary Crural Repair versus Primary Repair with Circular Bio-absorbable Hiatal Mesh Reinforcement in Hiatal Hernia Repair

To define the optimum laparoscopic hiatus hernia repair, ensuring long-term effect with minimal postoperative side effects.

Which approach for primary total hip arthroplasty results in faster short-term recovery? A comparison of the direct anterior approach with the posterior approach.

The purpose of this study is to compare short-term postoperative recovery following THA between patients operated via the direct anterior approach and the posterior approach, using patient-reported and objective performance-based outcome measures.

MyLeg P1: The functional evaluation of a ankle prosthesis prototype for osseointegrated transfemural amputees

To evaluate the performance of the newly-developed prosthesis (prototype) during walking in people with a transfemoral osseointegration implant. This will be done using lab-based measurement, evaluating metabolic cost, walking capacity, gait pattern…

IMPROVE: Evaluation of a combined lifestyle intervention program to improve quality of life in long-term ICU-survivors

Evaluation of the effects of a integrative lifestyle intervention program on health related quality of life after ICU-admission.

The RACC trial -Robot-assisted Approach to Cervical Cancer. A multi-centre open-label randomised non-inferiority trial of robotassisted laparoscopic surgery versus laparotomy in women with early stage cervical cancer.

We aim to demonstrate that robot-assisted laparoscopic radical hysterectomy is non-inferior to conventional laparotomy in recurrence free survival of patients with early stage cervical cancer (stage 1B1, 1B2 and 2A1).

Nocturnal Non-Invasive ventilation in COPD patients with stable hypercapnic respiratory failure: why and in which patient might this be effective?

Objectives: 1) To investigate change in FEV1 after 3 months nocturnal NIV in stable hypercapnic COPd patients as compared to standard care2) To investigate the relationship between FEV1 change and modification of systemic and airway inflammation and…

Balloon Expandable vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis

To compare safety and efficacy of EVOLUT R/Pro vs. SAPIEN3 Ultra for the treatment of a failing surgical aortic bioprosthesis

The Swallowing Exercise Aid in Total Laryngectomy: Feasibility, Adherence and a Multidimensional Assessment of Functional-, Physical-, and Patient-reported outcomes

The primary objective is to evaluate the feasibility and adherence of 6 weeks of rehabilitation with the SEA in participants who underwent TL. The secondary objective is to examine if the SEA is an effective tool to improve swallowing function and…

An open label, multi-center roll-over study to assess long-term effect in pediatric patients treated with Tafinlar (dabrafenib) and/or Mekinist (trametinib)

This study has been transitioned to CTIS with ID 2023-509276-42-00 check the CTIS register for the current data. Primary:To assess the long-term safety of treatment with dabrafenib, trametinib or the combination.Secondary:To assess the long-term…

A phase IIIb, multi-center, open-label, randomized study of tolerability and efficacy of oral asciminib versus nilotinib in patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (CABL001J12302)

This study has been transitioned to CTIS with ID 2024-510947-71-00 check the CTIS register for the current data. Primary:To assess the tolerability of asciminib versus nilotinib with respect to the time to discontinuation of study treatment due to…

Surgery and exercise versus exercise only for chronic patellofemoral pain syndrome: a randomised controlled trial.

Zie het onderzoeksprotocol 2: "Objectives".

Inducing optimism to enhance exposure effects in chronic pain patients

This project aims to investigate the additive value of an optimism intervention to an existing rehabilitation protocol for pain patients. It is expected that including an optimism module in an exposure in vivo treatment or a graded activity…

Withdrawal of Tiratricol Treatment in Males with Monocarboxylate Transporter 8 Deficiency (MCT8 Deficiency): A Double-blind, Randomized, Placebo-controlled Study

This study has been transitioned to CTIS with ID 2024-516124-34-00 check the CTIS register for the current data. Primary Objective:• To evaluate the effects of withdrawal of tiratricol treatment (placebo group) on serum total triiodothyronine (T3)…

An open-label, single arm, multicenter extension study to evaluate long-term safety and tolerability of inclisiran in participants with heterozygous or homozygous familial hypercholesterolemia who have completed the adolescent ORION-16 or ORION-13 studies (VICTORION-PEDS-OLE)

This study has been transitioned to CTIS with ID 2023-507278-41-00 check the CTIS register for the current data. The primary objective of the study is to evaluate the long-term safety and tolerability of inclisiran in participants with HeFH or HoFH

Phase 2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Sotatercept (MK-7962) in Children from 1 to Less Than 18 Years of Age With PAH on Standard of Care

This study has been transitioned to CTIS with ID 2023-504861-22-00 check the CTIS register for the current data. This study will assess the safety and tolerability of sotatercept in pediatric participants with PAH WHO Group 1 who receive PAH…