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Randomized study with a run-in feasibility phase to assess the added value of Clofarabine in combination with standard remission-induction chemotherapy in patients aged 18-65 years with previously untreated acute myeloid leukemia (AML) or myelodysplasia (MDS) (RAEB with IPSS â*¥ 1.5)

Primary objectivesFor part A of the study: -To determine the feasibility of Clofarabine when given at three possible dose levels together with standard induction cycles I and II in patients with AML/ RAEB with IPSS>=1.5 in a prospective…

Fecal Microbiota Transplantation to Restore Residual Beta Cell Function In Patients With Long-Duration Type 1 Diabetes Mellitus

To investigate whether fecal microbial transplantation (FMT) from either allogenic (individuals with type 1 diabetes and a highly preserved beta cell fraction) or autologous (own) donor, administered every 8 weeks during 6 months through a small…

SLEEP DEEP: sleep deepening as treatment augmentation for post-traumatic stress disorder

The primary objective of this study is to test whether deepening post-treatment sleep each night of a 5-day treatment program for PTSD using EEG-guided acoustic stimulation, will result an augmented overall treatment effect. In addition, two…

The effects of a colon-delivered multivitamin supplement on vigilance and cognitive performance under stressful working conditions in military subjects

This current study aims to examine the effects of a 6-week colon-delivered multi-vitamin supplement intervention on cognitive performance and stress levels in military under real-life, stressful working conditions.

Mean arterial pressure alarm compared to hypotension prediction index in preventing intraoperative hypotension

Primary Objective: The performance in preventing intraoperative hypotension of a MAP treatment alarm of 72 mmHg compared to the performance of the HPI alarm. Secondary Objectives: - The correlation between the MAP signal and HPI signal - The…

Early mobilization in the Intensive and Medium care unit by the use of mobile monitoring: a single center randomized trial

The aim of the study is to investigate whether the use of telemetry monitoring leads to the promotion of early mobilization, by an improvement in mobilization and strength measurements, in rehabilitating ICU/MCU patients. Secondary goal is whether…

Neural plasticity and recovery after early and intensive upper extremity motor training in people with cervical spinal cord injury.

This project aims to investigate peripheral and central neuroplasticity following an early (<13 weeks after injury) and intensive (8 weeks of 6 hours of additional therapy) upper extremity motor training program (EIUMT)…

Vision-MR Ablation Catheter 2.0 for Treatment of Ventricular Tachycardia

The purpose of the VISABL-VT clinical investigation is to demonstrate safety and efficacy of RF ablation of ventricular tachycardia (VT) attributable to ischemic cardiomyopathy (ICM) with the Vision-MR Ablation Catheter 2.0. Data collected from this…

Sodium channel mutations (SCN9A, SCN10A) in anterior cutaneous nerve entrapment syndrome (ACNES)

Our primary objective is to determine if there are (gain-of-function) mutations of Nav1.7 and Nav1.8 in patients with ACNES.Our secondary objective is to see if there is a difference between patients with and without mutations, and:- Known…

Neuromodulation of the Dorsal Genital Nerve in Patiënts with Persistent Genital Arousal Disorder

The primary aim is to investigate the effect of neuromodulation (via UCon) on the symptoms of patients with PGAD. The hypothesis we want to test is whether neuromodulation of the DGN reduces the severity of symptoms of PGAD.

Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP547 in Subjects with Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis

Primary objective* To assess the efficacy of EP547 compared to placebo on pruritus as assessed by the Worst Itch Numeric Rating Scale (WI-NRS)Secondary* To assess the efficacy of EP547 compared to placebo on the following:* Pruritus-related quality…

A 2-Part, Randomized, Double-blind, Double-Dummy, Placebo- and Active Comparator-controlled, Repeat Dose Study to Establish Proof-of-Concept of GRX-917 in Experimentally Induced Panic and to Further Characterize its Repeated Dose Pharmacokinetics and Pharmacodynamics in Healthy Subjects

Part 1:Primary Objective- To investigate whether repeated dose GRX-917 reduces panic symptoms elicited by an experimental 35% CO2 -induced fear challenge administered in healthy CO2-sensitive subjects. Secondary Objectives- To investigate whether…

Treatment of the fifth metatarsal shaft fractures: a randomised controlled trial.

The main objective is to determine function/clinical outcome, measured by the NRS-11 score for pain, 3 months after intervention and compare this between the surgery and conservative group. Secondary objectives are functional outcome as measured by…

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.

Ethanol submandibular duct ligation for drooling in children with neurodisabilities

the primary aim of this study is to evaluate the safety (adverse events and complaints) of submandibular duct ligation right after intraductal ethanol infusion into the submandibular salivary gland (Ethanol two-duct ligation [E-2DL] in order to…

Pilot study to validate scRNA sequencing and CyTOF analysis in intestinal biopsies from patients with inflammatory bowel disease

In this pilot study we will validate intestinal mucosa biopsies for usage in scRNA sequencing and CyTOF analysis for future research in patients with CD and UC. Key in this validation is the number of viable cells in mucosal biopsies and the number…

Glycocalyx restoration in chronic heart failure: a proof of concept, randomized, double-blind,
placebo-controlled study

To assess the efficacy of treatment with Endocalyx for chronic heart failure.

SUperiority of Perineoplasty as concomitant surgical procedure during Pelvic Organ prolapse Repair: a comparative cohort Trial (SUPPORT)

This study aims to demonstrate superiority of the research intervention (over standard of care) in [1] surgical success and [2] cost-effectiveness and non-inferiority in morbidity

Effect of cyclic versus continuous enteral nutrition on circadian rhythms in critical illness: the CIRCLES study

The primary objective is to evaluate whether cyclic daytime enteral feeding can decrease the disruption of circadian rhythms in critically ill patients compared to continuous enteral feeding. Secondary objectives are to evaluate the effect of cyclic…

A Phase 1, Randomized, Double-blind, Placebo-controlled Trial to Determine the Pharmacodynamics and Pharmacokinetics of OPC-214870 Following Repeated Oral Administration to Healthy Subjects

- To assess the CNS functional effects of OPC-214870 following dosing using Neurocart test battery