Clinical trials: sponsored by Radboud University Medical Center
Pulmonary Tuberculoses, Other Specified Pulmonary Tuberculosis
BTZ-043 - Multiple Ascending Dose (MAD) to Evaluate Safety, Tolerability and Early Bactericidal Activity (EBA)
This is a prospective, open label, two-centre, randomized, controlled, two-stage, phase Ib/IIa study to evaluate the safety, tolerability, PK, drug-drug interaction and bactericidal activity of BTZ-043 administered orally once…
- Trial name
- NCT04044001
- Testing
- BTZ-043, Rifafour e-275®, Probe Drug Cocktail
- Where
- 2 sites in South Africa
- Volunteers
- 78 people
- Sponsor
- Michael Hoelscher
Quality of Life, PROMs
Affordable, Tailored Physical Therapy for Financially Vulnerable People With Trauma-related Injuries (AFTER-TRAUMA)
SUMMARY Rationale: In the Netherlands, trauma-related injuries affect more than 700,000 people annually, and many require rehabilitation.
- Trial name
- AFTER-TRAUMA (NCT07795216)
- Testing
- Questionnaires
- Where
- Netherlands
- Volunteers
- 153 people
- Sponsor
- Radboud University Medical Center
Male Subfertility
The Impact of a Nutritional Supplement (Impryl®) on Male Fertility
Infertility is a worldwide problem and about 10%-15% of all couples will be affected by the inability to have children. In approximately 50% of infertile couples a male factor is involved.
- Trial name
- SUMMER (NCT03337360)
- Testing
- Impryl
- Where
- 21 sites in Netherlands
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
HIV Infection
An Adaptive Platform Trial for Evaluation of Novel Treatment Regimens in Children and Adolescents With HIV in Africa
The goal of the CHAPAS-5 clinical trial is to find out how well different HIV treatments work in children and young people (from 4 weeks up to under 15 years old) living with HIV, including those starting treatment for the first…
- Trial name
- CHAPAS-5 (NCT07792096)
- Testing
- Dolutegravir (DTG), Abacavir (ABC), Lamivudine (3TC)
- Volunteers
- 800 people
- Sponsor
- University College, London
Oncology
Promoting Response to IMmunotherapy by Exercise in Patients With Advanced Renal Cell Carcinoma
The primary aim of this study is to evaluate the feasibility of a supervised high intensity interval training (HIIT) program during first-line dual immune checkpoint inhibitor (ICI) therapy (nivolumab plus ipilimumab) in patients…
- Trial name
- PRIMER (NCT07680556)
- Testing
- HIIT
- Where
- 2 sites in Netherlands
- Volunteers
- 30 people
- Sponsor
- Radboud University Medical Center
Lyme Borreliosis, Nervous System
Doxycycline Boosted Therapy in Lyme Borreliosis: DoBo Study.
The goal of this clinical trial is to learn if hydroxychloroquine works to treat long-term complaints attributed to Lyme borreliosis in adults.
- Trial name
- DoBo (NCT07230028)
- Testing
- Hydroxychloroquin, Doxycycline
- Volunteers
- 50 people
- Sponsor
- Radboud University Medical Center
Aortic Valve Disease, Aortic Valve Stenosis
Colchicine and Inflammation in Aortic Stenosis
Aortic stenosis (AS) is the most common valvular heart disease in the developed world. Once symptomatic, untreated patients have a poor prognosis with five-year survival rate of 25%.
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Calcification, Inflammation
- Trial name
- CHIANTI (NCT05162742)
- Testing
- Colchicine
- Where
- Netherlands
- Volunteers
- 150 people
- Sponsor
- Radboud University Medical Center
Parkinson Disease, Prodromal Stage
Slow-SPEED-NL: Slowing Parkinson's Early Through Exercise Dosage-Netherlands
The goal of this clinical trial is to investigate the feasibility if a remotely administered smartphone app can increase the volume and intensity of physical activity in daily life in patients with isolated Rapid Eye Movement…
- Conditions
- Parkinson Disease, Prodromal Stage, Neurodegenerative Diseases, Parkinsonian Disorders
- Trial name
- Slow-SPEED-NL (NCT06193252)
- Testing
- Increase of physical activity volume and intensity with the use of a motivational smartphone application
- Where
- Netherlands
- Volunteers
- 110 people
- Sponsor
- Radboud University Medical Center
Atrial Fibrillation (AF)
Pulsed Field Ablation for Atrial Fibrillation Using the VARIPULSE™ Catheter
Rationale: Effectiveness of thermal ablation techniques for pulmonary vein isolation, to treat atrial fibrillation (AF), are hampered by frequent pulmonary vein reconnection and risks of collateral tissue injury.
- Trial name
- VARI-POWER (NCT07779369)
- Testing
- Pulsed Field Ablation (PFA) with the VARIPULSE™ catheter
- Volunteers
- 40 people
- Sponsor
- Radboud University Medical Center
Post-ERCP Acute Pancreatitis
An European Multi-centre Cohort Study for Unravelling Pharmacokinetic and Genetic Factors Underlying Post-ERCP Pancreatitis
Endoscopic retrograde cholangiopancreatography (ERCP) comes with a risk for post-ERCP pancreatitis (PEP), which accounts for considerable morbidity, high healthcare expenditure, and death.
- Trial name
- G-PEP (NCT05267379)
- Testing
- Take blood samples
- Where
- Netherlands
- Volunteers
- 700 people
- Sponsor
- Radboud University Medical Center
Pancreatic Cancer
Micro-Tech FNB Needle to Obtain Tissue Specimens of Pancreas Malignancy for Personalized Based Chemotherapy
Systemic chemotherapy can improve disease-related symptoms and/or prolong survival in patients with pancreatic cancer. Before the start of chemotherapy, the diagnosis pancreatic carcinoma must be confirmed by tumor tissue…
- Trial name
- MT-FNB (NCT05249075)
- Where
- Netherlands
- Volunteers
- 138 people
- Sponsor
- Radboud University Medical Center
Multi-organ Metastatic Colorectal Cancer
Chemotherapy and Maximal Tumor Debulking of Multi-organ Colorectal Cancer Metastases
The purpose of this study is to compare overall survival rates of colorectal cancer patients with multi-organ metastases with an indication for first line systemic treatment randomized for treatment with combination chemotherapy…
- Trial name
- ORCHESTRA (NCT01792934)
- Testing
- XELOX regimen according to standard procedures, FOLFOX regimen according to standard procedures, Surgery
- Where
- 29 sites in Netherlands, United Kingdom
- Volunteers
- 478 people
- Sponsor
- Radboud University Medical Center
HIV -1 Infection
Early Neutralizing Antibodies in Infants Living With HIV to Enhance Their Life (2)
The goal of this clinical trial is to learn if subcutaneous ePGT121v1-LS and VRC07-523-LS added to standard antiretroviral therapy (ART) is safe and helps improve HIV viral suppression in infants living with HIV in Mozambique and…
- Trial name
- ENABLE 2 (NCT07655141)
- Testing
- Broadly neutralizing antibody (bNAb) ePGT121v1-LS, Saline (0.9% NaCl), Broadly neutralizing antibody (bNAb) VRC07-523-LS
- Volunteers
- 73 people
- Sponsor
- Hospital Universitario 12 de Octubre
Agitation,Psychomotor
A Multicomponent Intervention Program to Prevent and Reduce ICU Agitation and Physical Restraint Use
Despite deleterious effects, physical restraints are still commonly used in (expected to become) agitated patients in Dutch ICUs (20-25%).
- Trial name
- PRAISE (NCT05783505)
- Testing
- Multicomponent intervention program
- Where
- 5 sites in Netherlands
- Volunteers
- 480 people
- Sponsor
- Radboud University Medical Center
Treatment Resistant Depression
Dutch-Depression Outcome Trial Comparing 5 Day Multi Daily Neuronavigated Theta Burst Sessions With 6 Weeks rTMS
INTRODUCTION Recent findings from three small studies (total n=59) suggest that three changes in repetitive Transcranial Magnetic Stimulation (rTMS) protocols, called the Stanford Neuromodulation Therapy (SNT) protocol…
- Trial name
- DDOTT (NCT05900271)
- Testing
- rTMS, iTBS
- Where
- 4 sites in Netherlands
- Volunteers
- 108 people
- Sponsor
- Amsterdam UMC, location VUmc
HIV -1 Infection
Early Neutralizing Antibodies in Infants Living With HIV to Enhance Their Life
The goal of this clinical trial is to learn if subcutaneous ePGT121v1-LS added to standard antiretroviral therapy (ART) is safe and helps improve HIV viral suppression in infants living with HIV in South Africa.
- Trial name
- ENABLE 1 (NCT07655128)
- Testing
- Broadly neutralizing antibody (bNAb) ePGT121v1-LS, Saline (0.9% NaCl)
- Volunteers
- 87 people
- Sponsor
- Hospital Universitario 12 de Octubre
Lynch Syndrome
Preventive Dendritic Cell Vaccination for Lynch Syndrome
The aim of this study is to assess safety, immunogenicity and feasibility of vaccination with neopeptide-loaded dendritic cells in Lynch Syndrome subjects who are known to be carrier of a germline MMR-gene mutation without signs…
- Trial name
- PREVENT-Lynch (NCT07412197)
- Testing
- DC vaccination
- Where
- Netherlands
- Volunteers
- 16 people
- Sponsor
- Radboud University Medical Center
Carotid Artery Plaque
Carotid Artery Plaque Vulnerability Assessment Using Ultrafast Ultrasound Techniques
Objective: To explore the association between spatio-temporal blood flow velocities (peak systole and end-diastole at prior-stenosis, at maximum stenosis, and post-stenosis) and carotid plaque vulnerability defined by histology…
- Trial name
- CAP-VALUE (NCT05218421)
- Testing
- Carotid ultrasound, Biospecimen collection and examination, Blood sample collection
- Where
- 2 sites in Netherlands
- Volunteers
- 70 people
- Sponsor
- Radboud University Medical Center
Chronic Pulmonary Aspergillosis
Deposition of Inhaled Liposomal Amphotericin B in Chronic Pulmonary Aspergillosis (CPA)
This study evaluates and aims to optimize inhalation treatment with nebulized liposomal amphotericin B in patients with chronic pulmonary aspergillosis.
- Trial name
- NIMBUS (NCT07530263)
- Testing
- 12 mg of nebulised 99mTc-liposomal amphotericin B, 24 mg of nebulised 99mTc-liposomal amphotericin B, SPECT/CT scan
- Where
- Netherlands
- Volunteers
- 18 people
- Sponsor
- Radboud University Medical Center
HER2 Positive Solid Tumor
TGW211 for Click-Cleavable Imaging in HER2-Positive Cancers.
In recent years, there is increasing interest in antibodies for imaging, antibody-drug conjugates (ADC) and targeted radionuclide therapy (TRT).
- Trial name
- CleavHER (NCT07009184)
- Testing
- [111In]In-DOTA-TCO-trastuzumab, Small molecule tetrazine trigger component
- Where
- Netherlands
- Volunteers
- 19 people
- Sponsor
- Radboud University Medical Center
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