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Evaluation of the additional effect of continuous ultrasound bladder monitoring in urotherapy for children with functional daytime urinary incontinence. The SENS-U trial

To evaluate cost effectiviness of the SENS-U (continuous ultrasonic bladder monitoring) in urotherapy for children with functional daytime urinary incontinence.

Model Informed preciSion doSIng tO iNdividualise and optimize pharmacotherapeutic treatment (MISSION) - Appendix 1: Prospective evaluation of Model informed precision dosing (MIPD) for tacrolimus and mycophenolic acid in paediatric patients with a kidney disease

Overall objective:To improve the existing drug prescribing and treatment monitoring process.Objective appendix 1: To prospectively evaluate the predictive performance of the MIPD strategy for tacrolimus and mycophenolic acid in paediatric patients…

The beneficial value of 18F FDG PET/CT in the follow-up of stage III non-small cell lung cancer patients

Primary Objective The primary objective of this study is to compare the 3-year overall survival of stage III NSCLC patients during follow-up surveillance with 18F FDG PET/CT versus follow-up with conventional CT surveillance. Secondary…

A prospective, randomized study comparing chemotherapy versus chemotherapy plus immunotherapy in patients with advanced non-small cell lung cancer with low TMB and oncogenic driver, STK11, KEAP1 or NFE2L2 mutation and a PD-L1 TPS

To compare the objective response rate between patients with metastatic non-small cell lung cancer characterized by PDL-1 TPS<50% and low TMB and either actionable mutation, inactivating STK11, KEAP1 or NFE2L2 mutations, treated by…

A Pre-Market, First-In-Human, Pilot, Interventional, Clinical Investigation to Evaluate the Safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) in premenopausal women with Abnormal Uterine Bleeding (AUB).

Primary ObjectiveTo evaluate the safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS).Secondary Objectives1. To evaluate the change of menstrual blood loss (MBL).2. To evaluate the effect of MBL on the quality of life (…

An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination with Pembrolizumab Versus Chemotherapy in Subjects with Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma that Expresses HER2 (IHC 1+ and Greater)

Primary Objectives:Associated pharmaceutical trial:To compare the efficacy of disitamab vedotin in combination with pembrolizumab to chemotherapy as first-line treatment in participants with advanced UC that expresses HER2Clinical…

Dolphin CONTINUE: A nutritional intervention aimed at improving neurodevelopmental outcome in infants at risk for or with early life brain injury

The main objective is to study the effect of the nutritional intervention versus the control product on white matter development (as assessed using tract based spatial statistics of fractional anisotropy) using a DTI scan at the corrected age of…

Non-invasive electrophysiological monitoring on the obstetric high

To investigate the effect of implementing continuous antepartum eCTG monitoring at the OHC, on perinatal and maternal outcomes and obstetric care

Clinical outcomes and cost-effectiveness of a diagnostic and treatment strategy of upfront CTCA plus selective non-invasive functional imaging compared with standard care in patients with chest pain and suspected coronary artery disease

This strategy will result in a reduction reduce the incidence of major adverse cardiovascular events (MACE) defined as death or non-fatal myocardial infarction and appear more efficient than care as usual.

Clinical Investigation of Clinical Safety and Performance of the SP-GRIPFLOW, Selective Cerebral Perfusion Catheter when used for Cerebral Perfusion During Aortic Arch Repair

The primary objective and hypothesis is to assess whether the SP-GRIPFLOW Catheter is safe and performs as intended. The primary hypothesis is that blood flow through the catheters and cerebral perfusion during open surgical repair of the distal…

Evaluating the Feasibility of a Gamified Lifestyle Change Intervention for Patients with Symptomatic Atrial Fibrillation (EHRA Class IIb or Higher): GAMES4CARE.

The primary objective of this study is to evaluate the adherence to a 3-month gamification intervention integrated with a recently developed platform for continuous lifestyle monitoring (Care-On) in patients with recurrent atrial…

Evaluation of popliteal artery entrapment in healthy individuals

To investigate in healthy individuals not having ELP whether DUS and dynamic MRI may reveal a compressed popliteal artery in rest and during provocative testing (pointing, plantar foot flexion).

Enhancing effect of dual interventions versus conventional TMS in the treatment of
depression

rTMS is an intensive but effective treatment that could benefit from further optimization. Cognitive control training (CCT) engages the same underlying neural circuitry as rTMS and has been shown to improve therapeutic response (Koster et al., 2017…

Thrombectomy in high-Risk Pulmonary Embolism - Device
versus thrombolysis Netherlands: TORPEDO-NL

To determine whether CDT in high-risk PE relative to systemic thrombolysis is:- more effective and safer in terms of a reduction of the composite endpoint on all-cause mortality and adverse events defined as treatment failure, major&…

UNIFAI

To generate a large, international Friedreich*s ataxia patient database (including healthy controls), alongside an integrated clinical and natural history database, which is linked to a biological samples and imaging repository, hereby creating a…

Optimizing parasite transmission to laboratory-reared mosquitoes following controlled human malaria infection with Plasmodium vivax asexual blood stage parasites in malaria-naïve healthy volunteers in the Netherlands

Main objective: Develop a protocol to reproducibly infect mosquitoes with blood from human study participants undergoing asexual blood stage CHMI with the P. vivax clone PvW1.Secondary objectives: Maximize mosquito infection rate with PvW1 by I)…

An Observational Study in Participants with Ryanodine Receptor 1-Related Myopathies (RYR1-RM) to Determine Optimal Endpoint Measurements.

Primary objective* To determine the extent to which muscle strength is affected in patients with RYR1-RM with autosomal dominantmutations and describe measurements over time.Secondary objectives* To determine the extent to which fatigue and…

Lifestyle Self-Monitoring of Individualized Multiple Risk Factor Management towards Disease Modification of Dementia and other Age-related Diseases ;Pilot Study: DEVELOPMENT OF A PERSONALIZED MULTI COMPONENT LIFESTYLE INTERVENTION AND TESTING OF THE BAM-COG TOOL AGAINST COGNITIVE DECLINE.

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BioZ - study
Biologics during pregnancy
Immune profiling of peripheral and endometrial immune cells of women with psoriasis treated with biologics

To identify the effect of psoriasis and the treatment with biologics on the pre-pregnancy uterine immune environment of psoriasis patients.

Multifactorial eye diseases

The purpose of this protocol amendment is to meet the current and future needs of the MacTel Project’s collaborating investigators and continue meeting initial objectives. In addition, a third objective is to understand the mechanisms involved in…