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The use of Virtual Reality for Cognitive Rehabilitation Following Acquired Brain Injury

Primary objective: Inpatient Group: The primary objective of the research with the inpatient group is to assess whether there is a treatment effect in cognition (at T2) compared to baseline (T1) using conventional rehabilitation, as compared to…

Precision Radiation treatment for Epilepsy

Objectives: Primary: to determine whether SRT reduces the seizure frequency resulting in a reduction of at least 75% (RAEC I-III) in patients with drug-resistant focal epilepsy when compared to standard of care. Secondary: Assess quality of life (…

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study with an Open-Label Extension to Evaluate the Efficacy and Safety of Oral Rilzabrutinib (PRN1008) in Adults and Adolescents with Persistent or Chronic Immune Thrombocytopenia (ITP)

Primary Efficacy Objective (Blinded Treatment Period)• To demonstrate the efficacy of rilzabrutinib versus placebo in participants with refractory/relapsed ITP, based on the durability of platelet response during the last12 weeks of the 24-week…

Autobiographical memory in refugees with PTSD: a multiple baseline study on the effects of the Memory Specificity Training (MEST) and a sleep protocol (SLEE-P) as a preparation for Narrative Exposure Therapy (NET)

The primary objectives of the current study are 1) to investigate the effect of the MEST and SLEE-P on targeting overgeneral autobiographical memory, sleep disturbance, and posttraumatic stress symptoms in refugees with PTSD, and 2) to explore…

A study on the effectiveness of a guided e-health sleep and biological clock intervention in university students (i-Sleep & BioClock)

The aim of this randomized controlled trial is to assess the effectiveness of a guided e-health sleep and biological clock intervention on sleep, mental health symptoms (depression and anxiety), functioning, and quality of life in university…

Effect of low dose galacto-oligosaccharides (GOS) on faecal gut microbiota in adult women

The primary objective is to investigate the effect of a 3 week intervention with either 1.,3 gram or 2 gram of GOS on the abundance of the genus Bifidobacterium in faecal samples in healthy women of 40 - 70 years old. The secondary objective is to…

The Dutch Parkinson GBA Ambroxol trial (DUPARG-AMBROXOL):
A randomised, double-blind, placebo-controlled, single-center trial with Ambroxol in Parkinson patients with a GBA mutation

The primary objective is to compare the effectiveness of ambroxol versus placebo on the MDS-UPDRS part III motor sub-score in the *practically defined OFF-medication state* in patients with moderate PD, carrying a GBA mutation. The hypothesis is…

Clinical Validation of the C-Arm Rotational View (CARV): Study Protocol of a Prospective Randomized Controlled Trial

To assess whether the application of CARV for intra-medullary nailing of tibial shaft fractures results in a more accurate rotationalalignment of the tibia in comparison to conventional (e.g., eyeballing of the surgeon according to current practice…

Minimally Invasive versus Open Lumbar Interbody Fusion Trial (MIOLIFT): a randomized controlled trial for surgical treatment of lumbar spondylolisthesis and foraminal stenosis

Currently, available literature on costs and clinical effectiveness of MITLIF compared to OTLIF for patients with lumbar spondylolisthesis and degenerative foraminal stenosis is not sufficient. With a steep increase in the number of instrumented…

Kairos-study: Sleep interventions in night shift workers

The current study aims to investigate two types of sleep interventions in night shift workers: a split sleep intervention strategy and a short sleep episode (powernap, max. 20 min) during a night shift. It will assess the effects of the two…

PT-STRESS study: a two-phase randomized study aimed at predicting and coping with non-response in the treatment of PTSD; the latter by alternating recommended trauma-focused treatments (EMDR/T-CBT), or by switching to interpersonal therapy (IPT).

The aim of the current study is to increase understanding of the effectiveness and efficiency of psychological treatment for patients with PTSD and to better personalize differential therapeutics.Key questions:1. Which generic predictors of…

A Partially Double-Blinded Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics of AST-004 as a Short Loading Intravenous infusion Followed by AST-004 as a Continuous Infusion in Healthy Adult Subjects.

Primary objective:• To evaluate the safety and tolerability profile of single intravenous doses of AST-004 given as a short loading intravenous infusion followed by a 6-hour continuous intravenous (IV) infusion in healthy adult subjects.Secondary…

*A personalized lifestyle approach for abdominal pain in Irritable Bowel Syndrome and inflammatory bowel disease: a proof of concept study using Experience Sampling Method (ESM) and a digital food diary (Traqq).'

Apart from its use to provide insight in IBS disease courses and in clinical research, ESM can provide patients with feedback about individual triggers of their symptoms, and thereby function as part of a personalized therapeutic strategy. This is…

Personalized Risk-Adapted Therapy in Post-Pubertal Patients with Newly Diagnosed Medulloblastoma (PersoMed-I)

The hypothesis is that personalised and risk-adapted treatment will improve outcome and reduce toxicity in post-pubertal patients with medulloblastoma.A further hypothesis is that clinical, magnetic resonance imaging (MRI) and voxel-based…

Affective touch; reducing pain in Parkinson patients study 2

To determine whether CT-optimal touch can reduce pain experience in patients with Parkinson.

The effect of acute stress on executive functioning and decision-making in healthy military personnel.

To study if acute stress has a significant effect on executive functioning scores in healthy military personnel.

A Phase 1b/2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Nebulized Bacteriophage Treatment in Outpatient Adult Cystic Fibrosis (CF) Subjects with Chronic Pseudomonas aeruginosa (PsA) Pulmonary Infection

Primary Objective:To evaluate the safety and tolerability of nebulized BX004-A in CF subjects with chronic PsA pulmonary infection.Exploratory Objective:To evaluate the effect of BX004-A on sputum PsA burden, lung function, frequency of APEs, and…

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Pharmacodynamics of Intravenously Administered Prothrombin Complex Concentrate (PCC) in Combination with a Selected FXa Direct Oral Anticoagulant (FXa DOAC) in Healthy Subjects.

Primary objective:• To assess, in healthy subjects, the pharmacodynamic (PD) properties of PCC in the presence and absence of selected DOACs.Secondary objectives:• To assess, in healthy subjects, the safety and tolerability of PCC in the presence…

A randomized, single-blind, placebo-controlled study to evaluate an oral cholera vaccination with intranasal rechallenge as adaptive immune challenge model

• To characterize the systemic response to mucosal immunization with an oral cholera vaccination challenge.• To characterize the local response to intranasal rechallenge after cholera vaccination as outcome measure for nasal mucosal immunity.• To…

Sodium-oxybate as a potential new treatment for catatonia in patients with depression, bipolar disorder or a psychotic disorder, a randomized controlled trial. The Laborit study.

We aim to investigate whether sodium oxybate can be used as a novel treatment in psychiatric patients with catatonia. Our primary objective is: To determine if sodium oxybate is effective as a novel treatment in psychiatric patients with catatonia…