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Prospective randomized multi-center controlled clinical investigation comparing PFO outcomes of the Occlutech Flex II PFO Occluder to standard of care PFO occlusion.

The purpose of this clinical study is the assessment of the safety and effectiveness of the Flex II PFO Occluder in the treatment of subjects 18 years of age or older who have had a cryptogenic stroke due to a presumed paradoxical embolism as…

Daily electrical stimulation to prevent recurring pressure ulcers in patients with a spinal cord injury compared to usual care

To investigate whether daily electrical stimulation of gluteal and hamstring muscles combined with usual care is more effective than only usual in individuals with chronic SCI who often have PU*s and/or are at high of recurring PU*s regarding: 1)…

Aspin: Neurosurgical Aspirin Intervention Prognostic Study; perioperative continuation versus discontinuation of aspirin in spinal surgery, a randomized controlled, noninferiority trial.

Co-primary objectives:Hemorrhagic complicationsPerioperative blood lossPerioperative blood loss is determined by measuring blood recovered in the suction device during surgery and weighting of blood saturated gauzes used during surgery. In case a…

Non-invasive vagus nerve stimulation in acute ischemic stroke.

The main objective will be to investigate whether treatment with nVNS on top of best medical practice in acute ischemic stroke patients results in smaller infarct volumes compared with the infarct volumes of patients not treated with nVNS.

A 12-month prospective, randomized, interventional, global, multi-center, active-controlled study comparing sustained benefit of two treatment paradigms (erenumab qm vs. oral prophylactics) in adult episodic migraine patients

The purpose of this study is to determine the sustained benefit on safety and efficacy of AMG 334 compared to oral prophylactics in episodic migraine patients who have previously failed 1 to 2 prophylactic migraine treatments and therefore have a…

A 12-month, open-label, multicenter, randomized, safety, efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) study of two regimens of anti-CD40 monoclonal antibody, CFZ533 vs. standard of care control, in adult de novo liver transplant recipients with a 12-month additional follow-up and a long-term extension (CONTRAIL I).

This study will allow the assessment of the ability of CFZ533 to replace calcineurin inhibitors (CNIs) in terms of anti-rejection efficacy, while providing potentially better renal function with an expected similar safety and tolerability profile.…

AMYPAD Prognostic and Natural History Study (PNHS), an open label, prospective, multicentre, cohort study in individuals without dementia to evaluate the additional value of quantitative amyloid imaging in determining Alzheimer*s Disease (AD) dementia risk

The aim of this study is to evaluate the additional value of quantitative amyloid imaging analysis for modelling and assessing Alzheimer*s Disease (AD) dementia risk in individuals without dementia, compared to a range of existing cognitive, imaging…

Darbepoetin for Ischemic Neonatal Stroke to Augment Regeneration

This study has been transitioned to CTIS with ID 2024-513042-12-01 check the CTIS register for the current data. To perform a double-blind randomized placebo controlled multicenter study with darbepoetin in infants with MRI confirmed PAIS and to…

*A prospective randomized multicenter study to demonstrate the superiority of the Barricaid® to discectomy for primary lumbar disc herniation*: Extended Follow-Up of the Barricaid® Annular Closure Device (ACD) Randomized Control Trial (RCT) Postmarket Cohort for Lumbar Disc Herniation and Interaction with Other Risk Factors

The purpose of this post-approval protocol amendment is to extend the follow-up of subjects who were originally enrolled in theRCT, EUBARD-CP_001 protocol. This study extension will examine the long-term survivorship of the Barricaid® ACD when…

Slow-SPEED-NL: Slowing Parkinson's Early through Exercise Dosage-Netherlands

The primary objective is to determine the feasibility of a remote intervention study to promote physical activity in people with iRBD. The secondary objectives are to determine the longitudinal effect of an exercise intervention in people with iRBD…

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy, Safety, and Tolerability of Subcutaneous Administration of Fremanezumab Versus Placebo for the Preventive Treatment of Chronic Migraine in Pediatric Patients 6 to 17 Years of Age

Main objective:The primary objective of the trial is to evaluate the efficacy of test investigational medicinal product (IMP) as compared to placebo IMP for the preventive treatment of chronic migraine (CM). Secondary objectives:To evaluate the…

The effect of hilotherapy on chemotherapy-induced peripheral neuropathy in the treatment of breast cancer with Paclitaxel.

Investigate the effect of hilotherapy on the severity of CIPN and nail toxicity, and its influence on treatment management and quality of life in patients with breast cancer during, and three and six months after treatment with Paclitaxel.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy, Safety, and Tolerability of Subcutaneous Administration of Fremanezumab Versus Placebo for the Preventive Treatment of Episodic Migraine in Pediatric Patients 6 to 17 Years of Age

Main objective:To evaluate the efficacy of fremanezumab as compared to placebo for the preventive treatment of episodic migraine (EM)Secondary objectives:-To evaluate the safety and tolerability of fremanezumab in the preventive treatment of…

A Multicenter, Open-Label Study Evaluating the Long-Term Safety, Tolerability, and Efficacy of Monthly Subcutaneous Administration of Fremanezumab for the Preventive Treatment of Episodic and Chronic Migraine in Pediatric Patients 6 to 17 Years of Age

This study has been transitioned to CTIS with ID 2024-512837-34-00 check the CTIS register for the current data. Main objective:To evaluate the long-term safety and tolerability of subcutaneous test IMP in the preventive treatment of migraine in…

Determination of the sleep improving effects of phenolics from an orange peel extract

The present study aims to determine whether hesperidin or a hesperidin/apigenin combined preparation can improve objective sleep duration and/or sleep quality, and/or improve perceived sleep quality and feelings of rest.

Insight into the prevalence of unruptured intracranial aneurysms in a targeted risk-factor population: towards targeted screening

Primary objective:- Determine the number of unruptured IAs in smoking women aged 50-60 years in the Dutch population in a cohort of 55 participants. Secondary objectives:- Evaluate the possible changes in quality of life associated with a screening…

Randomized, double-blind, sham-controlled trial to investigate combined occipital and supra-orbital neuromodulation in resistant migraine. The RECLAIM study.

To evaluate the safety and performance, including clinical benefit, of the PRIMUS System for the treatment of Resistant Migraine.