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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.

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…

Become Active in Beating osteoarthritiS (BABS): A randomized controlled trial on the effectiveness of a promotional campaign in improving the management of osteoarthritis and quality of care

An information campaign was developed targeting early-stage KHOA patients and healthcare professionals (HCPs) to optimise timing of referral to secondary care.

DE INVLOED VAN PREOPERATIEF EMOTIONEEL EN GEDRAGSMATIG FUNCTIONEREN VAN KINDEREN TUSSEN 6 EN 12 JAAR OP POSTOPERATIEVE PIJN NA ADENOTONSILLECTOMIE IN DAGZIEKENHUIS.EEN PROSPECTIEF COHORT ONDERZOEK.

The purpose of this research is to acquire a better understanding of the pain experience and the recovery of children between 6 and 12 years old who underwent a tonsillectomy/adenotonsillectomy. Primary research question:What is the…

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…

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…

A multicenter, international, randomized, placebo controlled, double-blind, parallel group and event driven Phase 3 study of the oral FXIa inhibitor asundexian (BAY 2433334) for the prevention of ischemic stroke in male and female participants aged 18 years and older after an acute non-cardioembolic ischemic stroke or high-risk TIA

This study has been transitioned to CTIS with ID 2023-503793-20-00 check the CTIS register for the current data. The main purpose of this study is to learn whether asundexian works better than placebo at reducing ischemic strokes in participants who…

A Two Part Phase IIa/b Multicentre, Randomised, Double-Blind,
Placebo-Controlled, Parallel Group Dose-ranging Study to Assess
Efficacy, Safety, and Tolerability of the Combination of
Zibotentan and Dapagliflozin, and Dapagliflozin Monotherapy
Versus Placebo in Participants with Cirrhosis with Features of
Portal Hypertension

This study has been transitioned to CTIS with ID 2023-505405-17-00 check the CTIS register for the current data. The main objective of this Phase IIa/b study is to demonstrate the effectof zibotentan on HVPG, and that dapagliflozin can mitigate…

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

Zie het onderzoeksprotocol 2: "Objectives".

Interventional, randomized, double-blind, parallel-group, placebo-controlled study of add-on eptinezumab treatment to brief educational intervention for the preventive treatment of migraine in patients with dual diagnosis of migraine and Medication Overuse Headache

This study has been transitioned to CTIS with ID 2024-510729-24-00 check the CTIS register for the current data. Primary Objective• To evaluate the efficacy of eptinezumab as add-on to BI for the prevention of migraine and treatment of MOHSecondary…

Transfer of feces in ulcerative colitis 2; improving efficacy

To study the efficacy and safety of FMT augmented by donor selection and repetitive dual route administration.To study microbiota composition, functional and metabolic changes as a result of dietary modulation and FMT.

The effects of antipsychotic maintenance therapy on brain volume: randomized (dis)continuation after remission of a first psychotic episode.

The aim of the proposed study is to investigate the effects of antipsychotic medication on total brain volume and specific brain structures known to be affected in schizophrenia, such as hippocampus, thalamus, caudate, parietal and prefrontal cortex…

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.

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.

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).

PROtective ventilation with high versus low PEEP during one-lung ventilation for THORacic surgery - PROTHOR: A randomized controlled trial

To compare a strategy using high PEEP (10 cmH2O) with recruitment maneuvers versus low PEEP (5 cmH2O) without recruitment maneuvers, during thoracic surgery under standardized one lung ventilation with low VT (5 mL/kg predicted body weight - PBW) in…

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.

Preoperative sodium glucose cotransporter 2 inhibitors for prevention of postoperative acute kidney injury in cardiac surgery patients - a randomized, placebo-controlled, multi-centre, phase IV clinical trial

This study has been transitioned to CTIS with ID 2024-515260-31-00 check the CTIS register for the current data. To investigate the potential of preoperative initiation and perioperative continuation until day 2 after surgery of the SGLT2 inhibitor…

Tirzepatide Study of Renal Function in People with Overweight or Obesity and
Chronic Kidney Disease with or without Type 2 Diabetes: Focus on Kidney
Hypoxia in Relation to Fatty Kidney Disease using Multiparametric Magnetic
Resonance Imaging (TREASURE-CKD)

This study has been transitioned to CTIS with ID 2023-506082-60-00 check the CTIS register for the current data. The objective of this study is to investigate the mechanism(s) of action of tirzepatide in the kidney, in participants who are…