Clinical trials: sponsored by UMC Utrecht
Hypertension, HIV
iHEART-SA Intervention Study
Using qualitative data during the formative phase the IHEART-SA research study filled deficiencies in knowledge regarding: 1) what barriers exist to integrating hypertension care within the HIV care setting in South Africa and…
- Trial name
- iHEART-SA (NCT05846503)
- Testing
- 1. Quality and info management system
- Where
- South Africa
- Volunteers
- 4,378 people, healthy volunteers welcome
- Sponsor
- University of Witwatersrand, South Africa
Focal Epilepsy, Intraoperative Monitoring
Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery. ( EpiGrid )
The objective of this prospective interventional monocentric clinical investigation is to evaluate the feasibility and performance of the flexible high-density SOFT ECoG electrode grids, manufactured by Neurosoft Bioelectronics…
- Trial name
- EpiGrid (NCT06205160)
- Testing
- SOFT ECoG subdural grid electrode
- Where
- Netherlands
- Volunteers
- 12 people
- Sponsor
- Neurosoft Bioelectronics SA
Prostatic Neoplasm
EBRT + Lu-PSMA for N1M0 Prostate Cancer
The PROQURE project aims to provide prostate cancer patients with more cure and better quality of life. The first part of this project (PROQURE-1) aims to explore an innovative combined modality treatment strategy for patients…
- Trial name
- PROQURE-1 (NCT05162573)
- Testing
- 177Lu-PSMA-617, EBRT
- Where
- 2 sites in Netherlands
- Volunteers
- 14 people
- Sponsor
- The Netherlands Cancer Institute
HIV-1-infection
Therapeutic Drug Monitoring to oPtimize ANtiretroviral regimeNs in HIV-infected Women Who wAnt to Breastfeed
This is a prospective, multi-center, longitudinal, mother-infant pair, therapeutic drug monitoring study. The aim of this study is to determine concentrations of antiretroviral drugs in plasma and breastmilk in people living with…
- Trial name
- PANNA-B TDM (NCT05642481)
- Testing
- Therapeutic drug monitoring in plasma of mother and child and in breastmilk
- Where
- 3 sites in Netherlands
- Volunteers
- 16 people
- Sponsor
- Radboud University Medical Center
Angina (Stable), Coronary Microvascular Disease
Coronary Sinus Reducer in Coronary Microvascular Disease
Coronary microvascular dysfunction (CMD) is a common cause of treatment- resistant angina that lacks evidence-based treatment options.
- Trial name
- REDUCE CMD (NCT06898541)
- Testing
- Coronary sinus reducer
- Where
- 2 sites in Netherlands
- Volunteers
- 50 people
- Sponsor
- UMC Utrecht
Locked-In Syndrome
First Study With a Brain Implant to Help Locked-in Patients Communicate at Home
In this study a new means of communication for people with locked-in syndrome will be tested. The investigators will record brain signals directly from the surface of the brain by means of a completely implantable system.
- Trial name
- UNP (NCT02224469)
- Testing
- ECoG (electrocorticography) sensing
- Where
- Netherlands
- Volunteers
- 6 people
- Sponsor
- UMC Utrecht
Laryngeal Squamous Cell Carcinoma, Hypopharynx Squamous Cell Carcinoma
Personalized Elective Neck Irradiation Guided by Sentinel Lymph Node Biopsy in Larynx and Pharynx Cancer. The PRIMO Study.
Rationale | Elective neck irradiation is performed in head and neck cancer patients treated with definitive (chemo)radiotherapy. The aim is to eradicate nodal metastases that are not detectable by pretreatment imaging techniques.
- Conditions
- Laryngeal Squamous Cell Carcinoma, Hypopharynx Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma
- Trial name
- PRIMO (NCT05333523)
- Testing
- Sentinel lymph node biopsy guided selective elective neck irradiation, Standard elective neck irradiation
- Where
- 9 sites in Netherlands
- Volunteers
- 242 people
- Sponsor
- Radboud University Medical Center
Cystic Fibrosis
Clinical Trial to Evaluate the Efficacy and Safety of Dirocaftor/Posenacaftor/Nesolicaftor in Adults With CF
CF is caused by mutations in the gene that encodes the 'Cystic Fibrosis Transmembrane Conductance Regulator (CFTR)' channel. To re-establish the function of this complex chloride channel, typically two to three drug modes of…
- Trial name
- CHOICES (NCT06468527)
- Testing
- Diponecaftor
- Where
- 16 sites in Belgium, France and 7 more
- Volunteers
- 41 people
- Sponsor
- Kors van der Ent
Head and Neck Neoplasms, Carcinoma, Squamous Cell
Uniform FDG-PET Guided Gradient Dose Prescription to Reduce Late Radiation Toxicity
The objective of the UPGRADE-RT trial is to investigate whether de-escalation of elective radiation dose and introduction of an intermediate dose-level in the treatment of head and neck cancer will results in less radiation…
- Trial name
- UPGRADE-RT (NCT02442375)
- Testing
- standard dose prescription, FDG-PET guided gradient dose prescription
- Where
- 5 sites in Netherlands
- Volunteers
- 300 people
- Sponsor
- Radboud University Medical Center
Locked-in Syndrome, Neuromuscular Diseases
Investigation on the Cortical Communication System
The goal of this clinical trial is to demonstrate communication through a brain implant in people in locked-in state, i.e. people with severe paralysis and communication problems.
- Conditions
- Locked-in Syndrome, Neuromuscular Diseases, Brainstem Stroke, Traumatic Brain Injury
- Trial name
- CortiCom (NCT06207591)
- Testing
- ECoG (electrocorticography) sensing
- Where
- Netherlands
- Volunteers
- 2 people
- Sponsor
- UMC Utrecht
COVID-19, Long COVID
CORona (COVID-19) Follow Up Study: Epidemiology, Pathophysiology, Prediction, and Communication
The CORFU study, funded by ZonMW, is a prospective, multiple, cohort study with a maximum follow-up of 24 months after COVID-19.
- Conditions
- COVID-19, Long COVID, Post COVID-19 Condition
- Trial name
- CORFU (NCT05240742)
- Testing
- no intervention, the CORFU study conducts analyses based on data which has been prospectively collected (and aggregated when possible) in 7 existing cohorts
- Where
- Netherlands
- Volunteers
- 4,291 people, healthy volunteers welcome
- Sponsor
- Maastricht University Medical Center
Schizophrenia and Related Disorders, Early Treatment-Resistance
The Effect of a Six Week Intensified Pharmacological Treatment for Schizophrenia Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.
Schizophrenia (SZ) affects approximately 4.5 million people across the European Union (EU) and is associated with annual healthcare and societal costs of 29 billion Euros.
- Trial name
- INTENSIFY SZ (NCT05958875)
- Testing
- Clozapine, Second-line Antipsychotics (treatment as usual)
- Where
- 13 sites in Austria, Germany and 3 more
- Volunteers
- 418 people
- Sponsor
- Dr. Inge Winter
Bipolar Depression
The Effect of a Six Week Intensified Pharmacological Treatment for Bipolar Depression Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.
Bipolar disorders affect approximately 4.5 million people across the European Union (EU) and are associated with high annual healthcare and societal costs.
- Trial name
- INTENSIFY BD (NCT05973786)
- Testing
- Escitalopram, Sertraline, Venlafaxine
- Where
- 13 sites in Austria, Germany and 4 more
- Volunteers
- 418 people
- Sponsor
- Dr. Inge Winter
Major Depressive Disorder, Treatment Resistant Depression
The Effect of a Six Week Intensified Pharmacological Treatment for Major Depressive Disorder Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.
Over 28 million people suffer from current depressive disorder in the European Union. Major depressive disorder (MDD) is one of the most common psychiatric illnesses.
- Trial name
- INTENSIFY MDD (NCT05973851)
- Testing
- Esketamine Nasal Product, Ketamine Hydrochloride, Esketamine hydrochloride
- Where
- 12 sites in Austria, Germany and 4 more
- Volunteers
- 418 people
- Sponsor
- Dr. Inge Winter
Telemedicine, Digital Health
Development of an International Remote Digital Care System for Accessible, Inclusive and Sustainable Pregnancy Care
Pregnancy care is under increasing pressure due to a rising number of women needing medical care, a shortage of obstetric healthcare professionals, and growing healthcare costs.
- Conditions
- Telemedicine, Digital Health, Pregnancy Complications
- Trial name
- PregnaDigit EU (NCT07191236)
- Where
- 4 sites in Netherlands, Spain and 1 more
- Volunteers
- 450 people
- Sponsor
- UMC Utrecht
Cerebral Palsy
European Newborn Study: Early Markers for a Better LifE
The goal of this observational study is to create a computer model to help doctors predict any problems occurring during development of babies after being diagnosed with brain injury.
- Trial name
- ENSEMBLE (NCT07189494)
- Where
- 8 sites in France, Germany and 3 more
- Volunteers
- 1,000 people
- Sponsor
- dr. M.J.N.L. Benders
Amputation, Surgical, Phantom Limb Pain
Prevention of PostAmputation Pain With Targeted Muscle Reinnervation
The goal of this study is to compare postamputation pain (phantom limb pain and residual limb pain) one year postoperatively in patients who received a lower extremity amputation (LEA) with standard nerve handling (neurectomy)…
- Conditions
- Amputation, Surgical, Phantom Limb Pain, Neuroma Amputation, Surgery
- Trial name
- PreventPAP (NCT06719245)
- Testing
- Targeted Muscle Reinnervation (TMR), Standard neurectomy
- Where
- 7 sites in Netherlands
- Volunteers
- 203 people
- Sponsor
- Leiden University Medical Center
Inherited Cardiac Disease
The Electronic Cardiovascular Genetics (eCG) Clinic for Presymptomatic Genetic Counselling
Inherited cardiovascular conditions generally inherit following an autosomal dominant pattern. When a mutation is detected in the proband, relatives can have predictive DNA testing, and - when they are carrier - be monitored and…
- Trial name
- eCG (NCT06431425)
- Testing
- eCG Family Clinic
- Where
- Netherlands
- Volunteers
- 170 people
- Sponsor
- UMC Utrecht
Osteogenesis Imperfecta
Boost Brittle Bones Before Birth
An exploratory, open label, multiple dose, multicentre phase I/II trial evaluating safety and efficacy of postnatal or prenatal and postnatal administration of allogeneic expanded fetal mesenchymal stem cells for the treatment of…
- Trial name
- BOOSTB4 (NCT03706482)
- Testing
- BOOST cells
- Where
- Sweden
- Volunteers
- 18 people
- Sponsor
- Karolinska Institutet
Immune Related Adverse Events, Immune-Mediated Hepatitis
Management of Immune Checkpoint Inhibition-related Hepatitis Using Low-dose Corticosteroids
This study evaluates the effectiveness of low-dose corticosteroids in managing grade 2-3 immune-related hepatitis in cancer patients treated with immune checkpoint inhibitors.
- Conditions
- Immune Related Adverse Events, Immune-Mediated Hepatitis, Cancer
- Trial name
- MIRA-HEP (NCT07167251)
- Testing
- Low-dose corticosteroids for immune-related hepatitis grade 3, Low-dose corticosteroids for immune-related hepatitis grade 2
- Where
- 2 sites in Switzerland, United Kingdom
- Volunteers
- 63 people
- Sponsor
- University Hospital, Basel, Switzerland