Clinical trials: sponsored by Radboud University Medical Center
Crohn Disease in Remission, Crohn Disease
Lengthening Adalimumab Dosing Interval in Quiescent Crohn's Disease Patients
Crohn's disease is a chronic inflammatory bowel disease. This disease can be treated with, among other things, biologicals such as adalimumab.
- Trial name
- LADI (NCT03172377)
- Testing
- Lengthening adalimumab dosing interval
- Where
- 22 sites in Netherlands
- Volunteers
- 174 people
- Sponsor
- Radboud University Medical Center
Intracerebral Hemorrhage, Surgical Procedures, Minimally Invasive
Dutch Intracerebral Hemorrhage Surgery Trial Pilot Study
Background: Intracerebral hemorrhage (ICH) accounts for 15-20% of all strokes in Western Europe, and contributes profoundly to mortality and disability.
- Trial name
- DIST pilot (NCT03608423)
- Testing
- Minimally-invasive endoscopy-guided surgery
- Where
- 10 sites in Netherlands
- Volunteers
- 169 people
- Sponsor
- Radboud University Medical Center
Sepsis, Endotoxemia, Immunosuppression
The Effects of Human Endotoxemia on Functional Capacity of Hematopoietic Stem and Progenitor Cells
We will investigate whether human endotoxemia induces changes in human bone marrow cells and their downstream effector cells. To comprehensively investigate underlying mechanisms behind functional and transcriptional changes in…
- Trial name
- LPS-BM (NCT05570643)
- Testing
- LPS
- Where
- Netherlands
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Pregnancy
Placental Passage and Disposition of Drugs: A Physiology-based Approach
The investigators aim to integrate the outcomes in physiology-based pharmacokinetic (PBPK) models to put the generated data into context with medical conditions that require maternal or fetal drug therapy (e.g. HIV).
- Trial name
- PIANO (NCT02438631)
- Where
- Netherlands
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
HIV Infections, Bariatric Surgery Candidate
The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine
a multicentre phase IV study to collect evidence that a doravirine-based regimen can be safely and effectively administered to virologically suppressed HIV-infected patients undergoing bariatric suregery.
- Trial name
- LABRADOR (NCT05536466)
- Testing
- bariatric surgery
- Volunteers
- 8 people
- Sponsor
- Radboud University Medical Center
Sepsis, Septic Shock
Pharmacokinetics of Amikacin and Cefuroxime in Critically Ill Patients.
Infections in critically ill patients are a major healthcare problem and an important source of morbidity and mortality. Since critically ill patients often have altered pharmacokinetics (PK) compared to non-critically ill…
- Conditions
- Sepsis, Septic Shock, Infection, Bacterial, Critically Ill
- Trial name
- PHARAOH (NCT04470973)
- Testing
- Cefuroxime, Amikacin
- Where
- Netherlands
- Volunteers
- 40 people
- Sponsor
- Radboud University Medical Center
Testicular Cancer
Determining the Clinical Relevance of the inTeraction Between AprepitaNt aNd EtoposiDe
Rationale: In pharmacokinetic studies, aprepitant was shown to be a moderate inhibitor of CYP3A4 activity. Etoposide is metabolised by CYP3A4.
- Trial name
- TANNED (NCT04935255)
- Testing
- Blood sampling - Pharmacokinetic assessment
- Where
- Netherlands
- Volunteers
- 17 people
- Sponsor
- Radboud University Medical Center
Clinical Deterioration
Clinical Outcomes After Implementation of COntinuous Vital Sign Monitoring On the General Ward.
In 2018, continuous monitoring (CM) of 5 vital signs with a wearable device, including automated MEWS calculation within the EMR were introduced on the surgical and internal medicine ward of our hospital.
- Trial name
- COCOMO (NCT04189653)
- Testing
- Continuous Monitoring
- Where
- Netherlands
- Volunteers
- 3,896 people
- Sponsor
- Radboud University Medical Center
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
Societal Merit of Intervention on Hearing Loss Evaluation
The primary objective of this study is to determine the (long term) effect of intervention with a CI in adult participants with progressive postlingual moderate/severe-to-profound sensorineural hearing loss on societal related…
- Conditions
- Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Hearing Loss, Adult-Onset, Hearing Loss, Bilateral Sensorineural, Progressive
- Trial name
- SMILE (NCT05525221)
- Where
- 5 sites in Netherlands
- Volunteers
- 156 people
- Sponsor
- Radboud University Medical Center
Surgery, Abdominal Adhesion
Predicting Abdominal Reoperation
Nationwide retrospective study, to predict the risk of abdominal reoperation.
- Trial name
- NCT05516420
- Volunteers
- 72,270 people
- Sponsor
- Radboud University Medical Center
Paroxysmal Nocturnal Hemoglobinuria, Eculizumab
The Pharmacokinetics and Pharmacodynamics of Eculizumab in Patients With Paroxysmal Nocturnal Hemoglobinuria
Because of the inter and intra individual variability in pharmacokinetics and pharmacodynamics of eculizumab in PNH patients, a tailored treatment approach for the individual is probably preferable.
- Conditions
- Paroxysmal Nocturnal Hemoglobinuria, Eculizumab, PK-PD
- Trial name
- PREPARE (NCT04079257)
- Testing
- Blood collection for measurement of eculizumab peak concentrations
- Where
- Netherlands
- Volunteers
- 27 people
- Sponsor
- Radboud University Medical Center
Autism Spectrum Disorder, Regulation, Self
Development of Self-regulation by Dialectial Behavioural Therapy in Adults With Autism
Individuals with autism spectrum disorder (ASD) are at risk to develop more pervasive emotion-dysregulation. In this study experiences of adults with ASD and severe emotion dysregulation with Integrative Dialectical Behaviour…
- Trial name
- DASHBOARD (NCT05502484)
- Testing
- Integrative Dialectical Behavioural Therapy (DBT)
- Where
- Netherlands
- Volunteers
- 30 people
- Sponsor
- Radboud University Medical Center
Salivary Gland Cancer, Salivary Duct Carcinoma
PSMA-PET Imaging Before and After ADT in Advanced SDC Patients
Explorative study, which evaluates the effect of androgen deprivation therapy (ADT) on the PSMA ligand uptake on 68Ga-PSMA-PET/CT in salivary duct carcinoma patients.
- Trial name
- ADT-SCAN (NCT04214353)
- Testing
- 68Ga-PSMA-PET/CT, 18FDG-PET/CT
- Where
- Netherlands
- Volunteers
- 14 people
- Sponsor
- Radboud University Medical Center
Glioblastoma
MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma
Objective: In preparation of a randomized controlled trial, the investigators aim to assess pilot data on technical feasibility and safety of laser interstitial thermal therapy (LITT) at Radboud University Medical centre and to…
- Trial name
- EMITT (NCT04596930)
- Testing
- Laser ablation thermal therapy
- Where
- Netherlands
- Volunteers
- 15 people
- Sponsor
- Radboud University Medical Center
Psoriasis, Psoriatic Arthritis
Discovery of Arthritis in Psoriasis Patients for Early Rheumatological Referral
Rationale: Psoriasis (PsO) is a common inflammatory skin disease. Besides the skin, it is recognized that this disease can affect multiple domains such as nails, joints and entheses.
- Conditions
- Psoriasis, Psoriatic Arthritis, Psoriasis Vulgaris, Psoriatic Nail
- Trial name
- DAPPER (NCT03816917)
- Testing
- cutaneous parameters of psoriasis (exposure), comorbidity (exposure), family history (exposure)
- Where
- Netherlands
- Volunteers
- 304 people
- Sponsor
- Radboud University Medical Center
Colonic Neoplasms, Neoplasm Recurrence, Local
Incidence, Risk Factor, Treatment and Overall Survival of Locoregionally Recurrent Colon Cancer
Data on disease recurrence was collected for all primary colon cancer patients diagnosed in the Netherlands over the first six months of 2015.
- Trial name
- NCT05475288
- Volunteers
- 3,554 people
- Sponsor
- Radboud University Medical Center
Acute Coronary Syndrome
Pre-hospital Rule-out of Acute Coronary Syndrome
Patients with chest pain suspected for non ST-segment elevation acute coronary syndrome (NSTE-ACS) are routinely transferred to the emergency department (ED).
- Trial name
- ARTICA (NCT05466591)
- Testing
- Pre-hospital rule-out strategy
- Where
- Netherlands
- Volunteers
- 866 people
- Sponsor
- Radboud University Medical Center
Ataxia Telangiectasia, ATM Gene Mutation
Effects of Vitamin B3 in Patients With Ataxia Telangiectasia
This clinical trial investigates the effects of nicotinamide riboside (vitamin B3) on the disease course of patients with ataxia telangiectasia.
- Trial name
- NCT03962114
- Testing
- Vitamin B3
- Where
- Netherlands
- Volunteers
- 24 people
- Sponsor
- Radboud University Medical Center
Mindfulness, Randomized Controlled Trial
Mindful Prevention of Psychopathology in Healthcare Workers During the COVID-19 Crisis (COVID-19 MindPreP)
The current study will be a randomized controlled trial (RCT) investigating an adapted online Mindfulness-Based Stress Reduction (MBSR) program versus daily online self-help mindfulness exercises, in preventing incident/prevalent…
- Conditions
- Mindfulness, Randomized Controlled Trial, Psychopathology, Health Personnel
- Trial name
- NCT04720404
- Testing
- Mindfulness-Based Stress Reduction, Self-help mindfulness/compassion exercises, Support as usual
- Where
- Netherlands
- Volunteers
- 201 people
- Sponsor
- Radboud University Medical Center
Parkinson Disease
Asleep MRI-guided Versus Awake Microelectrode Recording Guided Deep Brain Stimulation in Parkinson's Disease: A Comparative Effectiveness Trial
Rationale: Bilateral deep brain stimulation (DBS) of the subthalamic nucleus (STN) is a well-accepted treatment for Parkinson's disease (PD).
- Trial name
- ACCURATE (NCT05453331)
- Testing
- bilateral STN deep brain stimulation
- Volunteers
- 158 people
- Sponsor
- Radboud University Medical Center