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The promote study, a pilot: The characterization of the microbiome in pregnancy and prediction of pregnancy outcomes.

Research question: Is maternal microbiome dysbiosis in MOB an underlying mechanism in the pathophysiology of adverse maternal pregnancy and offspring outcome?Objectives: Analyse the differences between the gut and vaginal microbiome, maternal and…

Exploring new imaging opportunities using a large axial field of view PET-CT system

To explore the feasibility and opportunities for new imaging procedures, of relevance of Amsterdam UMC prioritized areas, that a ultra-high sensitivity total body PET-CT system can offer for improving diagnosis and dose reduction.The protocol…

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…

Endometrial waves in women with suspected gynaecological malignancy

Objective: Evaluate uterine contraction features (frequency, amplitude, direction, and coordination) using a dedicated speckle-tracking algorithm by 2D transvaginal ultrasound measurement in postmenopausal women presenting with vaginal bleeding or…

SIMBA study: Seven Tesla Imaging Biomarkers of Cognitive Outcomes after Treatment for Pediatric Brain Tumor

The primary objective is to examine relationships between neurocognitive performance and MRI parameters of brain vasculature, metabolism, and white matter diffusion in children who have been treated for posterior fossa tumor. Secondary objectives…

Repetitive Transcranial Magnetic Stimulation (rTMS) versus sham rTMS in
Body Dysmorphic Disorder

The main objective of this study is to investigate whether rTMS treatment will improve clinical outcomes in body dysmorphic disorder, by reducing BDD YBOCS outcomes. Furthermore to improve localization and rTMS treatment in the dorsolateral…

Prospective Hounsfield Unit measurements of intercorporal bone grafts remodelling towards spinal fusion.

This study has three specific objectives:1) to explore how the participants* intercorporal bone grafts HU develop over time in the first two years after fusion surgery.2) to explore the interobserver reliability of the HU measurements.3) to explore…

An open, prospective, multicenter investigation to evaluate the clinical outcome of PrimeTaper
EV implant in extraction sockets and healed ridges - A 5 year follow-up

1. Primary objectiveThe primary objective of this clinical investigation is to evaluate implant survival rate 1 year afterpermanent restoration (PR), i.e. implant in place 1 year after PR, Yes/No.2. Secondary objectivesThe secondary objectives are…

Functional MRI and Doppler ultrasound of living kidney donors and recipients: a longitudinal trajectory from donor to recipient

Through the utilization of fMRI and DUS we aim to illustrate the physiological change a kidney graft undergoes during a transplantation trajectory from donor to recipient. Secondarily, we intend to establish a baseline reference for normal…

Shifting the interpretation bias and attention bias with an online training in borderline personality disorder

The purpose of the current study is to test the effectiveness of both trainings (IBT and ABT) in a non-clinical and clinical sample, with the future goal of making the training available to all patients with BPS. The central objectives for this…

A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Patients 6 to 17 Years of Age with Episodic Migraine - the REBUILD-1

This study has been transitioned to CTIS with ID 2023-505836-36-00 check the CTIS register for the current data. Main Objective:To demonstrate the superiority of galcanezumab versus placebo in the prevention of migraine in (at least) 1 of the…

HEalthy Living in Inflammatory Arthritis (HELIA trial): a randomized controlled trial comparing efficacy between an interactive, online lifestyle intervention program and general nutrition recommendations

Lifestyle intervention programs reduce inflammatory activity and might, therefore, be of added value in the management of patients with an inflammatory arthritis. Therefore, the aims of this randomized controlled trial are: 1. To compare the…

A randomized controlled trial to investigate the (cost)effectiveness of oral immunotherapy with different allergens in young children with an established food allergy.

What is the clinical- and cost-effectiveness of early low-dose oral immunotherapy aimed at long-term tolerance induction in children under the age of 30 months with an established food allergy compared to routine care?What is the effect of early low…

Prospective clinical evaluation of Stargardt disease patients with the
appropriate genotype for development of antisense oligonucleotide therapy

The goal of this study is to characterize the natural history of STGD1 patients with the appropriate genotype for AON therapy and to identify the best clinical outcomes to measure therapeutic efficacy in clinical trials following completion of this…

Prospective, Post-market Evaluation of Safety and Efficacy of a Local Osteo-Enhancement Procedure (LOEP) in the Proximal Femur of Women in Europe With Osteoporosis

The primary objective of the study is to evaluate the post-market safety and BMD improvement of AGN1 LOEP in patients with osteoporosis in at least one hip. The secondary objective is to evaluate the post-market functional measures of clinical…

Real-time Pressure volume Loop monitoring as a guide for enhanced Understanding of changes in elemental cardiovascular physiology during Therapeutic strategies aiming for hemodynamic Optimization. Cohort II: Structural heart interventions (PLUTO-II).

The primary objective of this study is to describe and to quantify the change in cardiac mechanoenergetics, expressed by PVL monitoring (reflected by the parameters stroke work, potential energy and pressure-volume area), in patients undergoing…

The effect of virtual reality on postoperative pain and anxiety in cardiac surgery. (VRECOVERY trial)

The objective of this study is to investigate the effect of VR on post-operative pain and anxiety management in cardiac surgery patients undergoing a coronary artery bypass grafting (CABG) procedure.

An Open-Label Uncontrolled Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Activity of Nipocalimab in Children Aged 2 to less than 18 years with Generalized Myasthenia Gravis

This study has been transitioned to CTIS with ID 2022-502539-21-00 check the CTIS register for the current data. The purpose of this study is to determine the effect of nipocalimab on total serum immunoglobulin G (IgG) in pediatric participants 2 to…

Brain INvolvement in Dystrophinopathies: BIND: Deep functional phenotyping of Duchenne Muscular Dystrophy and Becker Muscular Dystrophy patients (WP5) Part 2

The primary objective of the second part of the study, which is the focus of this application, is to perform a comparative analysis of the cognitive profile and MRI outcomes of DMD/BMD patients.

Brain structure and neurocognitive development in sickle cell disease; a longitudinal cohort study (BRICK study)

The primary objective is to evaluate longitudinal developmental changes in brain structure in patients aged 6-18 years with SCD. The secondary objective is to analyze the longitudinal relations between biomarkers, demographic characteristics, brain…