Clinical trials: sponsored by Radboud University Medical Center
Traumatic Brain Injury, Severe Traumatic Brain Injury
Optimal Cerebral Perfusion Pressure Guided Therapy: Assessment of Target Effectiveness - II
After severe traumatic brain injury, adequate blood flow to the brain is essential for recovery. This depends on arterial blood pressure, yet intensive care units apply fixed targets to all patients - treating every brain and…
- Conditions
- Traumatic Brain Injury, Severe Traumatic Brain Injury, Intracranial Pressure, Cerebral Perfusion Pressure
- Trial name
- Cogitate II (NCT07287358)
- Testing
- Optimal cerebral perfusion pressure
- Where
- 4 sites in Netherlands
- Volunteers
- 62 people
- Sponsor
- Maastricht University Medical Center
Tuberculosis
Evaluation and Demonstration of New Tuberculosis Diagnostics for Indonesia
The goal of this cluster-randomised controlled trial (CRCT) is to learn whether the use of new non-sputum-based diagnostic tests and other intervention components for tuberculosis (TB) diagnosis in healthcare facilities (HCF) can…
- Trial name
- EVIDENT (NCT07293455)
- Testing
- nPOC Testing Intervention Package
- Where
- Indonesia
- Volunteers
- 40,000 people
- Sponsor
- Universitas Padjadjaran
Malaria
Safety, Tolerability, Pharmacokinetics, and Mosquitocidal Activity of Lotilaner in Healthy Participants in Mali.
This is a Phase 1b, single-cente, randomized, double-blind, placebo-controlled proof-of-concept study evaluating the safety, tolerability, pharmacokinetics and mosquitocidal activity of single oral doses of lotilaner in healthy…
- Trial name
- NCT07758985
- Testing
- Cohort 1 low dose lotilaner with a high-fat meal, Cohort 2 high dose lotilaner in fasted state, Cohort 3 high dose lotilaner with a high-fat meal
- Where
- Mali
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Ulcerative Colitis
Feasibility of a Multimodal Intervention Program to Optimize Treatment Outcomes in Ulcerative Colitis
This is a prospective, interventional pilot study to assess the feasibility and optimal timing of a multimodal intervention program in Ulcerative Colitis (UC) patients with active disease as well as in patients in remission.
- Trial name
- OPTIMIZE-UC (NCT05743153)
- Testing
- Multimodal intervention program
- Where
- Netherlands
- Volunteers
- 30 people
- Sponsor
- Radboud University Medical Center
HIV/TB Coinfection
Efficacy, Safety and Pharmacokinetics of DTG With RIF
The overall aim of the project is to evaluate optimal DTG dose for the combined treatment of TB and HIV infections with RIF based anti-TB therapy.
- Trial name
- NCT03731559
- Testing
- DTG 50 mg OD with food, DTG 50 mg BID
- Where
- 10 sites in Thailand
- Volunteers
- 123 people
- Sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
Prostate Cancer
Standard Moderately Hypofractionated RT vs. Ultra-hypofractionated Focal Lesion Ablative Microboost in Prostate Cancer
EBRT is one of the standard treatment options for patients with localized PCA. Based on the outcome of randomized trials, moderately hypofractionated RT(19-25 fractions of 2.5-3.4Gy) is considered equivalent to conventional…
- Trial name
- NCT05705921
- Testing
- Radiotherapy standard, Radiotherapy Hypo-FLAME
- Where
- Netherlands
- Volunteers
- 484 people
- Sponsor
- The Netherlands Cancer Institute
Mycobacterium Avium Complex Pulmonary Disease
A Prospective, Multicenter, Single-arm MAC-PD Cohort: a NTM-NET and ESGMYC Collaborative Study
To gain insight in the effectiveness of, adherence and adjustments to guideline-based three-drug antimycobacterial therapy in patients with Mycobacterium avium complex pulmonary disease (MAC-PD) during the first 6 months of…
- Trial name
- MAC-PD cohort (NCT05906316)
- Where
- 11 sites in United States, Belgium and 8 more
- Volunteers
- 100 people
- Sponsor
- Radboud University Medical Center
Nontuberculous Mycobacterial Lung Disease, Mycobacterium Avium Complex
Hypertonic Saline Inhalation for Mycobacterium Avium Complex Pulmonary Disease
The SALINE trial will investigate the effect of Hypertonic Saline inhalation plus best supportive care on burden of symptoms, clearance of mycobacteria and functional capacities in participants with Mycobacterium avium complex…
- Trial name
- SALINE (NCT05192057)
- Testing
- Hypertonic Saline inhalation
- Where
- Netherlands
- Volunteers
- 30 people
- Sponsor
- Radboud University Medical Center
Diaphragm Dysfunction, Weaning Invasive Mechanical Ventilation
Diaphragm Hibernation and Its Driving Factors in Mechanically Ventilated ICU Patients
Rationale: Patients with invasive mechanical ventilation (IMV) frequently develop diaphragm dysfunction and experience difficult weaning.
- Conditions
- Diaphragm Dysfunction, Weaning Invasive Mechanical Ventilation, Respiratory Failure, ICU
- Trial name
- DISSECT (NCT07819864)
- Where
- Netherlands
- Volunteers
- 112 people
- Sponsor
- Radboud University Medical Center
Trauma (Including Fractures), Multiple Trauma/Injuries
Affordable, Tailored Therapy for Financially Vulnerable People With Trauma-related Injuries
Financially vulnerable people experience higher rates of trauma-related injuries and often face barriers to accessing physical therapy services.
- Conditions
- Trauma (Including Fractures), Multiple Trauma/Injuries, Rehabilitation
- Trial name
- AFTER-TRAUMA (NCT07819877)
- Volunteers
- 17 people
- Sponsor
- Radboud University Medical Center
Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Chronic Fatigue
Modafinil for Debilitating Fatigue in Quiescent Inflammatory Bowel Disease MODIFI-IBD Trial)
The goal of this clinical trial is to learn if modafinil can treat severe fatigue in adults aged 18 to 75 years with quiescent inflammatory bowel disease (IBD).
- Trial name
- MODIFI-IBD (NCT07582458)
- Testing
- Modafinil
- Where
- 2 sites in Netherlands
- Volunteers
- 60 people
- Sponsor
- Radboud University Medical Center
Non ST Segment Elevation Acute Coronary Syndrome
Pre Hospital Triage of Patients at Intermediate and High Risk for ACS
RESEARCH QUESTION: Is a treatment strategy that includes direct referral to a PCI center for intermediate to high-risk patients with non-ST elevation acute coronary syndrome (NSTE-ACS), both cost-effective and non-inferior for…
- Trial name
- ARTICA-2 (NCT07252245)
- Testing
- Integrating the HEAR score and hs POC troponin into pre hospital triage decision-making:
- Where
- 3 sites in Netherlands
- Volunteers
- 1,048 people
- Sponsor
- Cyril Camaro
High Risk Localized Prostate Cancer, Synchronous Metastatic Hormone-Sensitive Prostate Cancer
Prospective Prostate Cancer Infrastructure
The goal of this observational study is to collect detailed long-term real-world data and biomaterials from men with high-risk localized prostate cancer and synchronous metastatic hormone-sensitive prostate cancer.
- Trial name
- ProPCI (NCT07560748)
- Where
- Netherlands
- Volunteers
- 700 people
- Sponsor
- Radboud University Medical Center
Neuroendocrine Tumor of Pancreas, Multiple Endocrine Neoplasia Type 1
Precision Radiotherapy Using MR-linac for Pancreatic Neuroendocrine Tumours in MEN1 Patients
Patients with the Multiple Endocrine Neoplasia type 1 (MEN1) syndrome are genetically predisposed for developping multiple pancreatic neuro-endocrine tumours (pNET).
- Trial name
- PRIME (NCT05037461)
- Testing
- High-dose-high precision MR-guided radiotherapy
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- J.M. de Laat
Abdominal Pain, Gallstone; Colic
RELIEF-pathway in Patients With Upper Abdominal Pain
Upper abdominal pain (UAP) is a common symptom and frequently the reason to visit the hospital. The prevalence of epigastric pain in the Dutch population is estimated to be as high as 37%.
- Conditions
- Abdominal Pain, Gallstone; Colic, Dyspepsia, Irritable Bowel Syndrome
- Trial name
- RELIEF (NCT06002516)
- Testing
- RELIEF-pathway
- Where
- Netherlands
- Volunteers
- 471 people
- Sponsor
- Radboud University Medical Center
Nociceptive Pain, Anesthesia
Comparison of the Surgical Pleth Index and the Nociception Level Index in the Pediatric Population
This observational study aims to compare two nociception monitoring methods. The Nociception Level (NOL) index and the Surgical Pleth Index (SPI) in the pediatric population during general anesthesia.
- Conditions
- Nociceptive Pain, Anesthesia, Pediatric Anesthesia, Nociception Monitoring
- Trial name
- NOLvsSPI (NCT07084935)
- Testing
- Connecting all patients to the nociception level index(NOL) and the surgical pleth index (SPI), All patient will receive a tetanic stimuli (60mA, 100hz) of 5 seconds before start of incision
- Where
- Netherlands
- Volunteers
- 40 people
- Sponsor
- Radboud University Medical Center
Osteoarthritis,Knee, Osteoarthritis Knees Both
Coach2Move: Physical Therapy to Improve Physical Activity in Individuals With Chronic MSK Conditions
Chronic musculoskeletal conditions (chronic low back pain, knee osteoarthritis, hip osteoarthritis) are the most common causes of long-term disability resulting in a loss of quality-of life for affected individuals and high costs…
- Conditions
- Osteoarthritis,Knee, Osteoarthritis Knees Both, Osteoarthritis Hip, Low Back Pain
- Trial name
- Coach2Move (NCT07806318)
- Testing
- motivational enhancement and planning
- Where
- United States
- Volunteers
- 94 people
- Sponsor
- University of Utah
Carcinoma Nasal Vestibule
Brachytherapy (Interventional Radiotherapy) for Squamous Cell Carcinomas of the Nasal Vestibule: Optimization of Dose and Technique
Rationale: Primary brachytherapy (also known as Interventional Radiotherapy, IRT) achieves high cure rates in cancer of the nasal vestibule (CNV) while preserving nasal aesthetics and function.
- Trial name
- BRAVO (NCT07801690)
- Where
- Netherlands
- Volunteers
- 300 people
- Sponsor
- Radboud University Medical Center
Pancreatic Disease, Pancreatic Cancer
The Effectiveness of Adding Braun Anastomosis to Standard Child Reconstruction After Pancreatoduodenectomy
The goal of this clinical trial (REMBRANDT) is to evaluate the effectiveness of adding an extra connection (i.e. 'Braun anastomosis') after standard reconstruction in pancreatic head resection in reducing the incidence of delayed…
- Conditions
- Pancreatic Disease, Pancreatic Cancer, Delayed Gastric Emptying
- Trial name
- REMBRANDT (NCT05709197)
- Testing
- Braun anastomosis, Standard Child reconstruction
- Where
- 12 sites in Netherlands
- Volunteers
- 256 people
- Sponsor
- Radboud University Medical Center
Advanced Solid Tumor
Dose Escalation Study of Immunomodulatory Nanoparticles
PRECIOUS-01 is an immunomodulating agent composed of the invariant natural killer T cell (iNKT) activator threitolceramide-6 (ThrCer6, IMM60) and the New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1) cancer-testis antigen…
- Trial name
- PRECIOUS-01 (NCT04751786)
- Testing
- PRECIOUS-01
- Where
- Netherlands
- Volunteers
- 15 people
- Sponsor
- Radboud University Medical Center
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