Clinical trials: sponsored by UMC Utrecht
Congenital Heart Disease, Executive Dysfunction
Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With Critical CHD
Advances in prenatal and neonatal care have improved outcomes in children with critical congenital heart disease (CCHD). With the increase in survival, neurocognitive problems such as executive functioning (EF) impairments have…
- Trial name
- LbH (NCT06267430)
- Testing
- Kleuter Extra training program
- Where
- 3 sites in Netherlands
- Volunteers
- 103 people
- Sponsor
- Erasmus Medical Center
Respiratory Tract Diseases, Influenza (Pandemic)
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
REMAP-CAP is a randomised, embedded, multifactorial, adaptive platform trial for community-acquired pneumonia. The purpose of this study is to evaluate the effect of a range of interventions to improve outcome of hospitalised…
- Conditions
- Respiratory Tract Diseases, Influenza (Pandemic), Influenza, Community Acquired Pneumonia
- Trial name
- REMAP-CAP (NCT02735707)
- Testing
- Ceftriaxone + Macrolide, Moxifloxacin or Levofloxacin, Piperacillin-tazobactam + Macrolide
- Where
- 408 sites in United States, Australia and 27 more
- Volunteers
- 20,000 people
- Sponsor
- UMC Utrecht
Acute Respiratory Infection, Acute Respiratory Tract Infection
POS-ARI-ER Observational Study of Acute Respiratory Infections
Acute respiratory infections (ARI) are one of the most frequent reasons for hospital admission and antibiotic use, and can be caused by a broad range of pathogens, including respiratory viruses with proven epidemic potential…
- Trial name
- POS-ARI-ER (NCT05814237)
- Testing
- Data collection
- Where
- 27 sites in Belgium, Croatia and 8 more
- Volunteers
- 11,750 people
- Sponsor
- European Clinical Research Alliance for Infectious Diseases (ECRAID)
Perinatal Arterial Ischemic Stroke, Perinatal Asphyxia
Intranasal Stem Cells to Treat Perinatal Brain Injury to Combat Cerebral Palsy
Hypoxic-ischemic brain injury (HIBI) is a leading cause of death and lifelong disability in near-term and term infants, most often caused by perinatal arterial ischemic stroke (PAIS, incidence approximately 1:5000 live births) or…
- Conditions
- Perinatal Arterial Ischemic Stroke, Perinatal Asphyxia, Hypoxic-Ischemic Brain Injury, PAIS
- Trial name
- iSTOP-CP (NCT07831746)
- Testing
- MSC, marrow
- Volunteers
- 162 people
- Sponsor
- UMC Utrecht
Traumatic Brain Injury (TBI)
Prognostic Model for Predicting Outcome After Moderate to Severe Paediatric Traumatic Brain Injury
Due to ethical and logistical challenges related to paediatric research, there is limited age-appropriate evidence for managing paediatric traumatic brain injury (pTBI).
- Trial name
- PROMPT (NCT07538440)
- Where
- United Kingdom
- Volunteers
- 2,000 people
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust
Acute Respiratory Tract Infection
A Long-term Observational Study Evaluating the Presentation and Management of Acute Respiratory Tract Infections in Primary Care Across Europe
Acute respiratory infection (ARI) is the commonest reason for consulting in community care. Furthermore, new and re-emerging pathogens are often first noticed in primary care (PC).
- Trial name
- POS-ARI-PC (NCT06282718)
- Where
- 3 sites in Belgium, France and 1 more
- Volunteers
- 2,000 people
- Sponsor
- European Clinical Research Alliance for Infectious Diseases (ECRAID)
Acute Otitis Media, Pain
Analgesic Ear Drops for Children With Acute Otitis Media
This trial aims to investigate whether analgesic ear drops added to usual care provide superior ear pain relief over usual care alone in children presenting to primary care with AOM.
- Trial name
- OPTIMA (NCT05651633)
- Testing
- lidocaine hydrochloride 5mg/g
- Where
- Netherlands
- Volunteers
- 29 people
- Sponsor
- UMC Utrecht
Appendicitis Acute, Acute Abdomen in Children
The Impact of a Diagnostic Strategy for Acute Appendicitis in Children With Acute Abdominal Pain in Primary Care
BACKGROUND Acute appendicitis (AA) in an early stage is difficult to distinguish from other (self-limiting) causes of acute abdominal pain (e.g.
- Trial name
- ISAAK (NCT06762275)
- Testing
- Diagnostic strategy
- Where
- Netherlands
- Volunteers
- 566 people
- Sponsor
- University Medical Center Groningen
Neonatal Hyperbilirubinemia, Treatment Decisions
Bilirubin Thresholds in Preterm Infants on Neonatal Intensive CarE Units: The B-NICE Trial
Rationale: Neonatal hyperbilirubinemia is highly prevalent in very preterm infants born <30 weeks. Since 2008, uniform Dutch phototherapy thresholds for preterm infants have been used nationwide, largely based on consensus.
- Conditions
- Neonatal Hyperbilirubinemia, Treatment Decisions, Neurodevelopmental Outcome, Phototherapy
- Trial name
- B-NICE (NCT07674537)
- Testing
- Phototherapy, Exchange Transfusion
- Where
- Netherlands
- Volunteers
- 680 people
- Sponsor
- University Medical Center Groningen
Refractory Epilepsy in Children, Refractory Epilepsy
Cannabidiol as add-on Therapy for Children With Refractory Epilepsy (CBD-uN1que), a High-quality Individualized Approach: a Series of N-of-1 Trials
The goal of this clinical trial is to learn if cannabidiol ("CBD-oil") works to treat severe epilepsy in children. It will also learn about the safety of cannabidiol.
- Conditions
- Refractory Epilepsy in Children, Refractory Epilepsy, Epilepsy
- Trial name
- CBD-uN1que (NCT07668856)
- Testing
- Cannabidiol (CBD) oral solution
- Where
- Netherlands
- Volunteers
- 50 people
- Sponsor
- UMC Utrecht
Bone Metastases in Subjects With Advanced Cancer, Radiotherapy
Timely Integration of Palliative Care in Oncology Care for Patients Referred for Palliative Radiotherapy on Bone Metastases: A Randomized Trial
Rationale: With improvements in systemic tumour-directed treatments for primary tumours, survival rates for patients with bone metastases are improving.
- Trial name
- TIPZO-RT (NCT06805396)
- Testing
- Palliative Care Consult
- Where
- 5 sites in Netherlands
- Volunteers
- 246 people
- Sponsor
- Roxanne Gal
Cleft Palate Children, Cleft Alveolar Ridge
Alveolar Cleft Repair Using Osteoinductive Ceramics
In this study, patients with unilateral cleft lip and palate are enrolled in a multicenter stepped wedge randomized trial ithat compares alveolar cleft closure using autologous bone harvested form the mandibular symphysis with an…
- Conditions
- Cleft Palate Children, Cleft Alveolar Ridge, Cleft Lip and Palate
- Trial name
- ACROSTIC (NCT05331456)
- Testing
- Unilateral alveolar cleft repair
- Where
- 4 sites in Netherlands
- Volunteers
- 84 people
- Sponsor
- UMC Utrecht
Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Network Adaptive Platform Trial
The Staphylococcus aureus Network Adaptive Platform (SNAP) trial is an International Multi-Centered Randomised Adaptive Platform Clinical Trial to evaluate a range of interventions to reduce mortality for patients with…
- Trial name
- SNAP (NCT05137119)
- Testing
- Cefazolin, Penicillin, Clindamycin
- Where
- 161 sites in United States, Australia and 11 more
- Volunteers
- 8,000 people
- Sponsor
- University of Melbourne
Breast Cancer
Cancer Of the BReast Asanas Study (COBRA)
Rationale: Women with hormone-receptor positive breast cancer are usually prescribed endocrine therapy for a period of 5-10 years. This treatment reduces the risk of recurrence and improves overall survival in these women.
- Trial name
- COBRA (NCT06480513)
- Testing
- live yoga, live remote yoga
- Where
- Netherlands
- Volunteers
- 140 people
- Sponsor
- UMC Utrecht
Haemophilia, Hemophilia A
Synovial Proliferation on Routine Ultrasound: Active or Inactive?
There is cumulating evidence for the presence of non-observed or subclinical joint bleeding in patients with haemophilia. Early detection of active subclinical synovial proliferation would allow early intervention in order to…
- Conditions
- Haemophilia, Hemophilia A, Hemophilia B
- Trial name
- 2BEGIN (NCT06809972)
- Testing
- Ultrasound imaging
- Where
- Netherlands
- Volunteers
- 46 people
- Sponsor
- Van Creveldkliniek
Diffuse Midline Glioma, H3 K27-Altered
Focused Ultrasound Blood-Brain Barrier Opening in Pontine Diffuse Midline Glioma to Enhance Temozolomide Therapy: Pilot Feasibility Study (FIDES)
This study is for people (children and adults) with a rare and aggressive brain tumor called H3K27-altered diffuse midline glioma (DMG) located in the pons, a deep part of the brainstem.
- Trial name
- FIDES (NCT07562971)
- Testing
- Focused Ultrasound (FUS) Blood-Brain Barrier Opening, Temozolomide (TMZ)
- Where
- 2 sites in Netherlands
- Volunteers
- 20 people
- Sponsor
- UMC Utrecht
Adolescence Idiopathic Scoliosis
A Randomized Intra-Patient Controlled Trial of MagnetOs™ Putty vs Autograft in Instrumented Posterolateral Spinal Fusion in Idiopathic Scoliosis Patients
SUMMARY Rationale: Delayed union is a problem in adolescent idiopathic scoliosis (AIS) surgery, especially at the distal end of the construct.
- Trial name
- MAIS (NCT07512336)
- Testing
- MagnetOs putty 2.5cc, autograft
- Volunteers
- 140 people
- Sponsor
- UMC Utrecht
Infection, Bacterial, Infection Prevention
Optimising Kangaroo Care to Reduce Neonatal Severe Infection/Sepsis and Resistant Bacterial Colonisation Among High-risk Infants in NICU.
NeoDeco is a pragmatic, multicenter, parallel-group, cluster-randomised hybrid effectiveness-implementation trial designed to evaluate the impact of implementing optimised Kangaroo Care (KC) at the unit level compared to standard…
- Trial name
- NeoDeco (NCT05993442)
- Testing
- Optimised kangaroo care
- Where
- 24 sites in Greece, Italy and 3 more
- Volunteers
- 3,080 people
- Sponsor
- PENTA Foundation
Subarachnoid Hemorrhage, Spontaneous
Multicenter Registry of Patients With Subarachnoid Hemorrhage
The purpose of this registry is to collect detailed information on the characteristics, treatment, and outcomes of patients with a subarachnoid hemorrhage.
- Trial name
- MEASURE (NCT07482124)
- Testing
- None, observational study
- Where
- 9 sites in Netherlands
- Volunteers
- 1,000 people
- Sponsor
- UMC Utrecht
Cystic Fibrosis (CF), CFTR-related Disorders
A Prospective Study of Advanced Diagnostics in People With an Unclear Diagnosis of Cystic Fibrosis
Sometimes it is very difficult to tell if someone has cystic fibrosis (CF), especially when they have rare CF genes. Without this certainty, they are unlikely to get the correct treatment so their health may be affected.
- Trial name
- ADVANCE-CFTR (NCT07402434)
- Testing
- Rectal Biopsy, Rectal biopsy taken opportunistically during endoscopy procedure for other reasons., Blood test for CFTR Genotyping
- Where
- United Kingdom
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Royal Brompton & Harefield NHS Foundation Trust