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Sitting interruption treatment as a personalized secondary prevention strategy in patients with coronary artery disease: a randomized clinical trial

The primary aim of this study is to compare the effect of the SIT LESS intervention versus usual treatment on sedentary time in patients with coronary artery disease directly after cardiac rehabilitation.

Safety, tolerability and immunogenicity of intradermal mRNA SARS-CoV2 vaccination in patients with
Fibrodysplasia Ossificans Progressiva

This study has been transitioned to CTIS with ID 2024-518686-10-00 check the CTIS register for the current data. To describe and investigate safety and tolerability of the intradermal delivery of two fractional doses of 3/3 µg Comirnaty Original/…

The effect of low-dose rhythmic 17-β-estradiol administration on bone turnover in postmenopausal women

To investigate the effect of low-dose rhythmic transdermal 17-β-estradiol on serum P1NP (marker of bone formation) and CTX (marker for bone resorption), versus continuous low-dose and standard-dose continuous transdermal 17-β-estradiol…

Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics and pharmacodynamics of monoclonal antibody TB31F in healthy malaria-naïve adults in the Netherlands

(protocol section 2) This phase 1 study aims to assess the safety and tolerability of monoclonal antibody TB31F administered intravenously or at escalating dose levels or subcutaneously in healthy, malaria naïve, adults. This study will also…

Monitoring the effect of oral anticoagulants during cardiac catheterisation

1) to investigate if patients on chronic NOAC treatment are sufficiently anticoagulated without additional UFH during CAG/PCI, and 2) if this sufficient anticoagulation can be confirmed pre-procedure by a point-of-care test, and3) to investigate if…

Anti-COVID19 VaccinaTion AKS-452X BOOSTER Study (ACT-BOOSTER study)

Hypothesis: A booster dose of the naked (i.e. non-adjuvanted) 5x concentrated AKS-452X vaccine, will provide an enhanced immune response after vaccination with any of the registered vaccines, either as primary vaccin or booster vaccin, against COVID…

A multicenter, randomized, double-blind, placebo-controlled study of enzastaurin for the prevention of arterial events in patients with vascular Ehlers-Danlos Syndrome (vEDS) confirmed with COL3A1 mutations, followed by an open label extension (OLE)

The aim of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of enzastaurin in preventing new arterial events (rupture, dissection, pseudoaneurysm, carotid-cavernous sinus fistula, or aneurysm, fatal or not) leading 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.

An exploratory, open label, multiple dose, multicentre phase I/II trial evaluating safety and efficacy of prenatal and/or postnatal infusion of allogenic expanded fetal mesenchymal stem cells for the treatment of severe Osteogenesis Imperfecta compared with historical and untreated prospective controls.;In the Netherlands patients will not be treated. Retrospective and prospective control patients will be included

This study has been transitioned to CTIS with ID 2023-504593-38-00 check the CTIS register for the current data. The aim of this trial is to infuse multiple doses of human 1st trimester liver-derived MSC for the treatment of severe OI to determine…

A Randomized, Observer-blind, First-in-Human Phase 1/2a Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health

The sites of the Netherlands will only participate in cohort 2. Primary objectives - cohort 2: - To evaluate the safety and reactogenicity of the selected dose of ExPEC10V in participants >=60 years of age with a history of UTI in the past 5…

Understanding overweight and obesity: The end of average

This project therefore adopts an urgently needed comprehensive individualized approach. We characterize each participant in a large sample of individuals varying in bodyweight by their own baseline comprehensive profile, including person…

Combined effect of Pregabaline and Oxycodone, and Lacosamide and Oxycodone, on breathing: an exploratory study in healthy volunteers
the POLO study

The objective of the study is to quantify the effect of pregabaline and lacosamide on oxycodone-induced respiratory depression.

SoFiT: A Study on fatigue in colorectal cancer survivors, a lifestyle intervention

The objective of the study is investigate the relationship between adherence to the recommendations for cancer prevention of the WCRF and cancer-related fatigue in colorectal cancer survivors.

TURN-COVID Biobank:
The Dutch cohort study for the evaluation of the use of neutralizing monoclonal antibodies and other antiviral agents against SARS-CoV-2

This study has been transitioned to CTIS with ID 2024-515263-60-00 check the CTIS register for the current data. - A. What are the SARS-CoV-2 viral load kinetics during and after treatment with neutralizing monoclonal antibodies and other antiviral…

A Randomized, Double-blind, Placebo-controlled Trial on the Prevention of Chronic Postoperative Pain after Inguinal Hernia and Knee Surgery by Postoperative Treatment with Tapentadol.

This study has been transitioned to CTIS with ID 2024-511010-21-00 check the CTIS register for the current data. To prevent the development of chronic postoperative pain after inguinal hernia surgery and knee replacement surgery and to to further…

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Adeno-Associated
Virus Serotype 8 (AAV8)-Mediated Gene Transfer of Human Ornithine Transcarbamylase
(OTC) in Patients with Late-Onset OTC Deficiency

This study has been transitioned to CTIS with ID 2024-514337-38-00 check the CTIS register for the current data. PrimaryTo evaluate the efficacy of DTX301 on the improvement of OTC function by maintaining safe plasma ammonia levelsSecondaryTo…

Efficacy and feasibility of ketamine on acute suicidality, a multicenter double blind randomized placebo-controlled trial
(Ketamine Trial for Acute suicidality, KETA)

The aim of this study is to find a directly applicable intervention for acutely suicidal patients, so that the risk of these patients committing suicide is substantially lowered, leading to fewer actual suicides. To this end we propose a randomized…

Peri-Operative ISchemic Evaluation-3 Trial

Perioperative bleeding in the setting of noncardiac surgery is strongly associated with 30-day cardiovascular complications and mortality. Trial evidence suggests that intravenous TXA reduces perioperative bleeding and transfusion in orthopedic…

Travel-Imported Arbovirus infections and mHealth applications for outbreak Risk Assessment: ZIeKA monitor part 2

Our primary objective is to enable rapid estimation of the current and future risks of importation into the Netherlands of majorarboviral Aedes-borne diseases (Dengue, Chikunguya, Zika and Yellow Fever viruses). The possibility of (re)establishment…

A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Protein ConM SOSIP.v7 gp140 Vaccine, Adjuvanted with MPLA Liposomes, in Healthy, HIV-Uninfected Adults

The primary objective of this study is to evaluate the safety and tolerability of intramuscular administration of the HIV-1 envelope protein ConM SOSIP.v7 gp140 vaccine, adjuvanted with MPLA liposomes, in HIV-uninfected adults. The secondary…