Clinical trials: sponsored by Copenhagen University Hospital, Rigshospitalet
Bloodstream Infection, Bloodstream Infection Due to Central Venous Catheter
Oral Switch in Bloodstream Infections in Immunocompromised Children
This nationwide, multicenter, randomized non-inferiority trial aims to determine whether an switch to oral antibiotic therapy (experimental arm) is non-inferior to standard intravenous antibiotic therapy (control arm) with…
- Conditions
- Bloodstream Infection, Bloodstream Infection Due to Central Venous Catheter, Immunocompromised Patients, Bacteremia Sepsis
- Trial name
- Oral_Switch (NCT07923266)
- Testing
- Oral antibiotic therapy, Standard IV antibiotic therapy
- Where
- 4 sites in Denmark
- Volunteers
- 114 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Coronary Artery Disease, Chest Syndrome
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
The purpose of the DYNAMITE trial (Dynamic CT stress myocardial perfusion, CT fractional flow reserve (FFR-CT) and coronary CT angiography for optimized treatment strategy in patients with chest pain syndromes) is to determine…
- Conditions
- Coronary Artery Disease, Chest Syndrome, Acute Myocardial Infarction, Heart Failure
- Trial name
- DYNAMITE (NCT04709900)
- Testing
- CT angiography, FFR-CT and stress CT myocardial perfusion
- Where
- Denmark
- Volunteers
- 2,000 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Brain Tumor, Pediatric, Cancer-related Fatigue
Methylphenidate in Pediatric Brain Tumor Survivors With Cancer-related Fatigue
Cancer-related fatigue is a common and debilitating late effect in pediatric brain tumor survivors. Currently, evidence-based recommendations to ameliorate this condition are lacking.
- Conditions
- Brain Tumor, Pediatric, Cancer-related Fatigue, Methylphenidate
- Trial name
- EMBRAIN (NCT06905587)
- Testing
- Methylphenidate (MPH)
- Where
- 4 sites in Denmark
- Volunteers
- 50 people
- Sponsor
- Odense University Hospital
Obesity, Overweight
FutureShape Family
The number of adults and children living with obesity is increasing worldwide. Once childhood obesity has developed, more than 80% of children carry the obesity into adulthood, with a high risk of cardiometabolic disease, poor…
- Trial name
- NCT07872904
- Testing
- Family Care, Standard Care, Semaglutide (administered by PDS290 pen-injector)
- Where
- Denmark
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Signe Torekov
Preterm Birth, Artificial Intelligence (AI) in Diagnosis
Does AI Make Clinicians More Appropriately Confident? A Randomized Study in Preterm Birth Prediction
The goal of this randomized questionnaire-based study is to evaluate how different presentations of artificial intelligence (AI) decision support influence clinical judgment among medical doctors working in obstetrics and…
- Trial name
- NCT07402668
- Testing
- AI prediction (binary), AI risk estimate (%)
- Where
- 18 sites in Denmark
- Volunteers
- 246 people, healthy volunteers welcome
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Spasticity, Muscle
Effect of Treatment Dairy for Spasticity
1. Assessing whether the treatment diary can help optimize the overall treatment of patients. 2. To assess whether the patient finds the treatment diary useful and worth spending time on.
- Trial name
- NCT03384927
- Where
- Denmark
- Volunteers
- 96 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Bloodstream Infection, Bacteremia Sepsis
Oral Switch in Pediatric Bloodstream Infections
This nationwide, multicenter, randomized, non-inferiority trial of children and adolescents with uncomplicated bloodstream infections aims to investigate if early-oral antibiotic switch (experimental arm) is non-inferior to…
- Trial name
- Oral_Switch (NCT07791914)
- Testing
- Oral antibiotic therapy, Standard IV antibiotic therapy
- Where
- 18 sites in Denmark
- Volunteers
- 150 people
- Sponsor
- Ulrikka Nygaard
Neonatal Resuscitation, Apnea Neonatal
Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates
Many extremely premature infants require immediate help with breathing after birth. Positive pressure ventilation (PPV) using a device called a T-piece resuscitator is a common method.
- Trial name
- MVP (NCT06849596)
- Testing
- Ventilator derived positive pressure ventilation - V-PPV, T-piece resuscitator (TPR)
- Where
- 11 sites in United States, Canada and 1 more
- Volunteers
- 780 people
- Sponsor
- Michelle Baczynski
Sarcoma
Paediatric Sarcoma, Hybrid Imaging & FAPI - Raising the Diagnostic Standard for Paediatric Sarcoma Patients, Combining Novel Radiotracer FAPI and Whole-body PET/MRI
The goal of this clinical trial is to evaluate [68Ga]FAPI-46 whole-body PET/MRI as a diagnostic tool to improve tumour lesion examination at primary staging, during treatment control and at relapse in paediatric sarcoma patients.
- Trial name
- PsiFI (NCT07861217)
- Testing
- FAPI tracer
- Where
- Denmark
- Volunteers
- 40 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Preterm, Father-Child Relations
The SUPPORTED Study - First-time Fathers of Preterm Infants.
The purpose is to support first-time fathers of premature infants in early parenthood by promoting early paternal-infant relationships.
- Trial name
- NCT06116747
- Testing
- Intervention
- Where
- Denmark
- Volunteers
- 915 people, healthy volunteers welcome
- Sponsor
- Hvidovre University Hospital
Neuromuscular Blockade
Neuromuscular Monitoring in Children (6 Months - 2 Years) With Electromyography and Acceleromyography
The aim of this study is to compare AMG and EMG (Philips IntelliVue NMT module and Senzime TetraGraph) in the objective monitoring of neuromuscular blocking in children between the age of 6 months and 2 years.The monitoring will…
- Trial name
- NCT06409260
- Testing
- Acceleromyography (AMG), Electromyography (EMG)
- Where
- Denmark
- Volunteers
- 107 people, healthy volunteers welcome
- Sponsor
- Matias Vested
Congenital Hyperinsulinism (CHI)
Umbilical Cord Glucose
Congenital hyperinsulinism (HI) causes persistent neonatal hypoglycemia that, if untreated, can lead to neurodevelopmental impairments (NDI) such as cognitive delays, cerebral palsy, epilepsy, and blindness.
- Trial name
- Save The Brain (NCT07795047)
- Testing
- For the screening, the interventions will be glucose measurements (and possibly G-BOBH), while follow-up assessments will include Bayley testing, EEG, and MRI.
- Volunteers
- 50 people
- Sponsor
- Odense University Hospital
Emergence Delirium
MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children
Postoperative agitation and emergence delirium describe a spectrum of symptoms of early postoperative negative behavior, in which the child experiences a variety of behavioral disturbances including crying, thrashing, and…
- Trial name
- MELA-PAED (NCT05541276)
- Testing
- Melatonin, Isotonic sodium chloride solution
- Where
- Denmark
- Volunteers
- 676 people
- Sponsor
- Arash Afshari
Emergence Delirium
The PREVENT AGITATION Trial II - Children ≤1 Year
Emergence agitation is a clinical condition in which the child experiences a variety of behavioural disturbances including crying, thrashing, and disorientation during early awakening from anaesthesia.
- Trial name
- NCT05091242
- Testing
- Clonidine, Sodium chloride
- Where
- 2 sites in Australia, Denmark
- Volunteers
- 336 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Limb Girdle Muscular Dystrophy
MRI-phenotyping of Patients With Pathogenic Anoctamin 5 Variants
A large cohort of MRI scans from patients with pathogenic variants in the anoctamin 5 gene will be collected through an international collaboration to better describe muscle involvement.
- Trial name
- ANO5 MRI (NCT05102799)
- Testing
- No intervention
- Where
- Denmark
- Volunteers
- 200 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Infratentorial Neoplasms, Mutism
Cerebellar Mutism Syndrome Study
The purpose of this study is to determine why up to 25% of the pediatric patients who have surgery for a tumor in the posterior fossa develops the Cerebellar Mutism Syndrome (CMS).
- Trial name
- NCT02300766
- Where
- 32 sites in Austria, Belgium and 12 more
- Volunteers
- 2,000 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Fetal Growth Abnormalities, Fetal Weight
Impact of AI Feedback on Ultrasound Biometry Accuracy Across the Expertise Levels
Objective: To evaluate the impact of real-time AI feedback on fetal biometry accuracy and investigate the Expertise Reversal Effect-whether AI benefits diminish as user experience increases.
- Trial name
- NCT07476638
- Testing
- AI interventional group
- Where
- 3 sites in Denmark
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Copenhagen Academy for Medical Education and Simulation
Fetal Growth, Obstetric Ultrasonography
Clinicians' Trust in AI-Based Fetal Growth Estimates
This study examines how clinicians trust and use artificial intelligence (AI) when estimating fetal weight during pregnancy. Accurate assessment of fetal growth is important for identifying growth problems that may affect…
- Conditions
- Fetal Growth, Obstetric Ultrasonography, Pregnancy, Clinical Decision-making
- Trial name
- NCT07401368
- Testing
- Intervention - AI Performance Information
- Where
- Denmark
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Vascular Malformations
Bleomycin Electrosclerotherapy (BEST) for Slow-flow Vascular Malformations
Slow-flow vascular malformations consist of abnormally formed veins, capillaries, lymphatic vessels, or a combination of these. They can cause pain, swelling, functional limitations, and concerns about appearance and may…
- Trial name
- NCT07720570
- Testing
- Bleomycin electrosclerotherapy (BEST)
- Where
- Denmark
- Volunteers
- 60 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Congenital Cytomegalovirus, Cytomegalovirus Infections
Protein Biomarkers and Host RNA Expression Profiles in Congenital Cytomegalovirus Infection
This study seeks to identify and test host protein biomarkers and RNA expression profiles in dried blood spot samples as novel diagnostic markers of congenital cytomegalovirus sequelae and to improve the understanding of the…
- Conditions
- Congenital Cytomegalovirus, Cytomegalovirus Infections, Neonatal Infection, Sensorineural Hearing Loss
- Trial name
- NCT07635368
- Where
- 2 sites in Denmark
- Volunteers
- 630 people, healthy volunteers welcome
- Sponsor
- Copenhagen University Hospital, Rigshospitalet