Clinical trials: sponsored by Radboud University Medical Center
Cardiovascular Diseases
High-fat Challenge Induced Trained Innate Immunity (SHAKE Study)
The goal of this randomized controlled cross-over trial is to investigate whether a single high-fat challenge can induce trained innate immunity in healthy volunteers.
- Trial name
- NCT05682456
- Testing
- High-fat shake, Reference shake
- Where
- Netherlands
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Oesophageal Cancer, Esophageal Stent Stenosis
Esophageal Multisegmented FCSEMS for Malignant Strictures
Objective: To assess the safety and feasibility of the implementation of the esophageal multisegmented fully covered self-expandable metal stent (SEMS) for the palliation of patients with malignant dysphagia.
- Trial name
- EATERS (NCT04415463)
- Testing
- Multisegmented fully covered self-expandable metal stent
- Where
- Netherlands
- Volunteers
- 23 people
- Sponsor
- Radboud University Medical Center
Ulcerative Colitis Flare
Local and Systemic Immunoprofiling of Patients Diagnosed With Ulcerative Colitis
Immune-mediated diseases are extremely diverse - patients with the same diagnosis may see the disease progress in very different ways, and respond differently to treatments.
- Trial name
- ImmUniverse (NCT05680883)
- Where
- Netherlands
- Volunteers
- 40 people
- Sponsor
- Radboud University Medical Center
Inflammatory Bowel Diseases
Treatment Outcomes of Advanced Neoplasia in IBD
In this study, we aimed to (1) compare cumulative incidences of synchronous and metachronous colorectal neoplasia as well as mortality following AN in CD and UC patients who underwent proctocolectomy, (sub)total colectomy…
- Trial name
- NCT05674773
- Testing
- Endoscopic or surgical resection
- Where
- Netherlands
- Volunteers
- 189 people
- Sponsor
- Radboud University Medical Center
Dementia, Nursing Home Resident
Video Feedback Intervention in Nursing Home Residents With Dementia and Severe Challenging Behavior.
The purpose of this study is to evaluate how, under what circumstances and for whom the video feedback intervention works for (the caregivers of) people with dementia and severe challenging behavior in a nursing home setting.
- Conditions
- Dementia, Nursing Home Resident, Challenging Behavior
- Trial name
- NCT05658666
- Testing
- Video feedback intervention (in Dutch: Video Interventie Ouderenzorg)
- Where
- Netherlands
- Volunteers
- 25 people
- Sponsor
- Radboud University Medical Center
Sepsis, Immune Deficiency
Assessing the Effects of CytoSorb Hemoperfusion on the Development on Immunoparalysis
In this randomized, open-label study, the investigators will assess whether CytoSorb hemoperfusion will prevent or attenuate the development of immunoparalysis in healthy volunteers undergoing repeated experimental endotoxemia.
- Conditions
- Sepsis, Immune Deficiency, Hemoperfusion, Blood Purification
- Trial name
- EndoSorb (NCT04643639)
- Testing
- CytoSorb hemoperfusion
- Where
- Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Glioblastoma
Glioblastoma Imaging Using a Strong Iron-like Bloodpool Contrast Medium?
Rationale: Visualization of tumor spread is of crucial importance when treating patients suffering from glioblastoma (GBM) as the success of tumor resection depends strongly on the extent of tumor infiltration.
- Trial name
- NCT05656300
- Testing
- MRI scan using USPIO particles
- Volunteers
- 15 people
- Sponsor
- Radboud University Medical Center
Non-small Cell Lung Cancer
Imaging Tumor-infiltrating T-cells in Non-small Cell Lung Cancer
This is an interventional study, to assess feasibility and safety of durvalumab (MEDI4736) in neo-adjuvant setting in patients with resectable NSCLC. Additional analyses of potential imaging biomarkers, e.g.
- Trial name
- Donan (NCT03853187)
- Testing
- Zr-89 labelled durvalumab PET/CT, Durvalumab (MEDI4736)
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- Radboud University Medical Center
Depressive Disorder, Major
Pharmacogenetics Informed Tricyclic Antidepressant Dosing (PITA)
Tricyclic Antidepressants (TCA's) are the cornerstone of treatment for patients with severe Major Depressive Disorder (sMDD). Current dosing is guided by repeated measurements of blood levels.
- Trial name
- PITA (NCT03548675)
- Testing
- TCA treatment
- Where
- Netherlands
- Volunteers
- 125 people
- Sponsor
- Radboud University Medical Center
GLUT1 Deficiency Syndrome, GLUT1DS1
Sodium Lactate Infusion in GLUT1DS Patients
This study investigates the effect of lactate infusion on epileptic discharges on EEG and seizure frequency in glucose transporter 1 deficiency syndrome (GLUT1DS) patients.
- Conditions
- GLUT1 Deficiency Syndrome, GLUT1DS1, GLUT1DS2, Epilepsy
- Trial name
- NCT04112862
- Testing
- sodiumlactate
- Where
- Netherlands
- Volunteers
- 2 people
- Sponsor
- Radboud University Medical Center
Prostate Cancer, Prostate Neoplasm
Addition of a Focal Boost in External Beam Radiotherapy for Locally Advanced Prostate Cancer by Online Adaptive MR-guided Radiotherapy
The AFFIRM trial tests the safety and clinical feasibility of MR-guided hypofractionated focal boost radiotherapy for patients with locally advanced prostate cancer.
- Trial name
- AFFIRM (NCT05373316)
- Testing
- Ultrahypofractionated MR-guided radiotherapy boost
- Where
- 2 sites in Netherlands
- Volunteers
- 95 people
- Sponsor
- Radboud University Medical Center
Burnout, Professional, Caregiver Exhaustion
Effect of Implementation of a Moral Case Delibration Meetings on the Prevalence of Burn-out Syndrome in the ICU
Burnout syndrome (BOS) has a high prevalence in critical care nurses and physicians. Both personal characteristics and work-related factors have been associated with BOS.
- Trial name
- MCDIC (NCT04442438)
- Testing
- Monthly moral case deliberation
- Where
- 2 sites in Netherlands
- Volunteers
- 435 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Diabete Type 2, Obesity
The GATE Study: Endoscopic Sutured Gastroplasty in Type 2 Diabetic, Obese Patients Using the Endomina Device
Rationale: Diabetes mellitus is a chronic disease that is often associated with long-term macrovascular and microvascular complications and decreased life expectancy.
- Trial name
- GATE (NCT05599477)
- Testing
- Endoscopic sutured gastroplasty with endomina
- Volunteers
- 40 people
- Sponsor
- Radboud University Medical Center
Drug-drug Interaction
Determining the Clinical Relevance of the Interaction Between Enzalutamide and the Opioid Morphine and the DOAC Edoxaban
Enzalutamide is one of the oncolytic drugs that showed efficacy and safety in most of the features of prostate cancer. Approximately 17% of the patients treated with enzalutamide need pain control.
- Trial name
- MIND THE GAP (NCT05339672)
- Testing
- Blood sampling - Pharmacokinetic assessment
- Where
- 3 sites in Netherlands
- Volunteers
- 26 people
- Sponsor
- Radboud University Medical Center
Prostate Neoplams, Magnetic Resonance Imaging, Laser Ablation
MRI-guided Focal Laser Ablation Prostate Cancer
Prostate cancer is the most frequent malignancy in the male population of developed countries and has a substantial socio-economic impact.
- Trial name
- NCT05370482
- Testing
- Focal laser ablation
- Where
- Netherlands
- Volunteers
- 10 people
- Sponsor
- Radboud University Medical Center
Stem Cell Transplant Complications, Oral Complication
Oral Complications After Haematopoietic Stem Cell Transplantation: a Retrospective Study
Haematopoietic stem cell transplantation (HSCT) is a potentially lifesaving treatment option for various diseases. It involves infusion of stem cells after a conditioning regimen of chemotherapy with or without total body…
- Trial name
- RadboudStem (NCT05595070)
- Testing
- Haematopoietic stem cell transplantation
- Where
- Netherlands
- Volunteers
- 200 people
- Sponsor
- Radboud University Medical Center
Invasive Fungal Infections, Pharmacokinetics
Pharmacokinetics of Isavuconazole in Patients in the Intensive Care Unit
20 patients admitted to the ICU department and receiving isavuconazole as part of standard care for the treatment of fungal infections will be included in the study.
- Conditions
- Invasive Fungal Infections, Pharmacokinetics, Intensive Care Unit
- Trial name
- ICONIC (NCT04777058)
- Where
- 4 sites in Belgium, Netherlands
- Volunteers
- 20 people
- Sponsor
- Radboud University Medical Center
Invasive Fungal Infections
Pharmacokinetics of Fluconazole in Children (2-18 Years)
30 pediatric patients aged 2-18 years receiving fluconazole as part of standard care for the treatment or prophylaxis of an invasive fungal infection will be included in the study.
- Trial name
- FOCUS (NCT05130723)
- Where
- 2 sites in Netherlands
- Volunteers
- 30 people
- Sponsor
- Radboud University Medical Center
Head and Neck Squamous Cell Carcinoma
SPIO-enhanced MRI in Oral Cancer for Sentinel Lymph Node Identification
To explore the feasibility of sentinel lymph node identification by SPIO injection followed by MRI in head-and-neck cancer patients.
- Trial name
- MAG-NODE (NCT04803331)
- Testing
- SPIO-enhanced MRI
- Where
- Netherlands
- Volunteers
- 10 people
- Sponsor
- Radboud University Medical Center
Head and Neck Squamous Cell Carcinoma
Validation of USPIO-enhanced MRI for Detection of Lymph Node Metastases in Head and Neck Carcinoma
This study evaluates the diagnostic accuracy of USPIO enhanced MRI for the detection of lymph node metastases in head-and-neck squamous cell carcinoma (SCC) using histopathology as a gold standard.
- Trial name
- USPIO-NECK (NCT03817307)
- Testing
- USPIO-enhanced MRI
- Where
- Netherlands
- Volunteers
- 25 people
- Sponsor
- Radboud University Medical Center