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Sustained employability in cancer patients and their partners (STEPS)

(1) To evaluate the (cost-)effectiveness of an individual rehabilitation program on RTW and continuation of work in cancer patients with an employment contract, compared to care as usual (CAU). In addition, we will investigate the effect of the…

A Phase 4, Multicenter Study to Evaluate Discontinuation and Re-Treatment in Subjects with Tenosynovial Giant Cell Tumor (TGCT) Previously Treated with Pexidartinib

Main objective: Proportion of subjects who remain treatment-free.Secondary objectives: - Change from Baseline in Patient Reported Outcomes (PROs) (PROMISPF, EQ-5D-5L)- Safety: Total number of subjects in the safety analysis set with any AEcollected…

Neo-adjuvant nivolumab or nivolumab with ipilimumab in advanced cutaneous squamous cell carcinoma patients prior to standard of care surgery; the MATISSE trial

Herewith, we present a research protocol for a phase II trial that allows us to examine the efficacy (histopathological response rate) of ICI in the form of nivolumab or nivolumab plus ipilimumab prior to SOC in patients with resectable stage III-…

Effectiveness of methylphenidate in children and adults with Smith Magenis syndrome and attention-deficit/hyperactivity disorder: An N-of-1 series

The primary objective is to determine the efficacy of methylphenidate on ADHD symptoms in Smith Magenis syndrome.The secondary objectives include the efficacy of methylphenidate on emotion dysregulation and specific goals that are important to the…

A PHASE I/II, MULTICENTER, OPEN-LABEL, MULTI-ARM STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PRELIMINARY ACTIVITY OF IDASANUTLIN IN COMBINATION WITH EITHER CHEMOTHERAPY OR VENETOCLAX IN THE TREATMENT OF PEDIATRIC AND YOUNG ADULT PATIENTS WITH RELAPSED/REFRACTORY ACUTE LEUKEMIAS OR SOLID TUMORS.

This study will evaluate the safety, tolerability, and pharmacokinetics of idasanutlin as a single agent and the safety, tolerability, pharmacokinetics, and preliminary efficacy of idasanutlin in combination with either chemotherapy or venetoclax in…

The Effect of Tirzepatide versus Dulaglutide on Major Adverse Cardiovascular Events in Patients with Type 2 Diabetes (SURPASS-CVOT)

This study has been transitioned to CTIS with ID 2023-507846-96-00 check the CTIS register for the current data. The main reason for conducting this study is to help in answering the following research question:• How tirzepatide compares to…

A confirmatory, prospective, open-label, single-arm, reader-blinded multi-centre phase 3 study to assess the diagnostic accuracy of Ferumoxtran-10-enhanced Magnetic Resonance Imaging (MRI) and unenhanced MRI in reference to histopathology in newly-diagnosed prostate cancer (PCA) patients, scheduled for radical prostatectomy (RP) with extended pelvic lymph node dissection (ePLND)

Primary Objectives1. To confirm superiority of Ferrotran®-enhanced MRI over unenhanced MRI in sensitivity to detect metastases in normal size pelvic lymph nodes in using histopathology after lymph node dissection as established reference method (…

Decoding words with 7 Tesla functional MRI

The overall goal of this study is to assess the detection and discrimination of individual silently or attempted spoken words from the brain area that represents articulation of speech.To address this goal, we defined three primary objectives:1) To…

A randomized clinical trial to evaluate the efficacy of polyethylene glycol vs psyllium fiber to prevent rebleeding in patients hospitalized with bleeding diverticular disease.

To evaluate the efficacy of laxatives (polyethylene glycol) versus supplementation of fibers on the incidence of rebleeding in patients hospitalized for colonic diverticular bleeding.

Prediction of REsPonse to Antipsychotics using electRoEncephalography

The aim of this study is to validate EEG prediction markers of antipsychotic treatment outcome in patients with psychosis. *

A prospective Phase I/IIa, open-label, multicenter trial to evaluate the safety and efficacy of oNKord®, an off-the-shelf, ex vivo-cultured allogeneic NK cell preparation, in subjects with acute myeloid leukemia who are in morphologic complete remission with measurable residual disease and who are currently not proceeding to allogeneic hematopoietic stem cell transplantation.

Primary ObjectivesThe primary objectives are:• The primary safety objective is to evaluate the safety and tolerability of the infusion of up to three doses of oNKord®• The primary efficacy objective is to assess the cumulative incidence of MRD…

Ex vivo genetic correction of LAMA2 mutations in myogenic stem cells of patients with merosin-deficient congenital muscle dystrophy type 1a (MDC1a)

This study aims to isolate and culture myogenic stem cells called mesoangioblasts from the muscle biopsies to explore if genetic correction of LAMA2 mutations using CRISPR-Cas9 can be achieved and subsequently assess the effect in vitro, as a first…

Systematic Hospital-based Assessment of Rotterdam*s critically Ill children,
their Neurodevelopment and Growth

The main objective of this longitudinal study is to gain insight into the neurodevelopmental trajectories following neonatal critical illness, from the perinatal period to school-age compared to healthy controls. This insight may lead to the…

Nervus X- Atrial Fibrillation trial (NX-AF)

The primary objective is to examine the impact of t-LLVS on electrophysiological properties of the atria and ventricles. Secondary objectives are:- to elucidate the correlation between proteostasis marker levels in serum and atrial tissue, and the…

Clinical study of comfort, pain and time to return to previous activities with conservative treatment of clavicle fractures with a 2 point-sling or broad arm sling

ObjectivesThe aim of this study is to measure if there is a significant difference in comfort, pain and recovery of function between treatment with a broad arm sling or a 2 points-sling in patients with a collarbone fracture, treated conservatively.…

B-Fine: An open label, single arm study to mechanistically interrogate the therapeutic effect of GSK3228836 in patients with Chronic Hepatitis B via intrahepatic immunophenotyping

Primary objective:To assess the effect of 12 weeks of GSK3228836 on serum hepatitis B virus surface antigen (HBsAg) levels in participants with CHBSecondaryEfficacy: To assess sustainability of serum HBsAg loss by GSK3228836 for up to 24 weeks off-…

Intensive Care Unit specific Virtual Reality for family members (ICU-VR-F) of patients in the ICU.

Our primary objective is to determine the effect of ICU-VR-F on symptoms of depression, anxiety and PTSD, and the health-related quality of life (HRQoL) in family members of ICU patients. The secondary objective is to determine the effect of ICU-VR-…

Evaluation of pessary placement on the anatomy of the pelvic organs in patients with pelvic organ prolapse using imaging techniques

This protocol describes a framework that will be used to create multiple studies, which are based on the secondary objectives. The outcomes of the studies together will provide more insight in the primary objective. Primary Objective: Investigate…

A multicenter, open-label post authorization safety study to evaluate the effect of LysaKare® infusion on serum potassium levels in GEP-NET patients eligible for Lutathera® treatment

Primary objective(s): To assess the effect of LysaKare® administration on serum potassium concentration in GEP-NET patients eligible for Lutathera® treatmentSecondary objective(s): To confirm the safety profile of LysaKare® infusion in GEP-NET…

AN OPEN-LABEL, PHASE I STUDY OF NEO-PTC-01 IN PATIENTS WITH ADVANCED OR METASTATIC MELANOMA

This study has been transitioned to CTIS with ID 2023-508524-35-00 check the CTIS register for the current data. The primary objective of this study are 1) to evaluate the safety and determine the highest tolerable dose of NEO-PTC-01 in patients…