Clinical trials: sponsored by Odense University Hospital
Kidney Transplant Recipient, Sodium Glucose Co-Transporter 2 Inhibitors
SGLT2i Effect on PTDM Development and Kidney Allograft Function in Non-diabetic Kidney Transplant Recipients: A Randomized, Doubleblind, Placebo Controlled, National Multicenter Trial
The goal of this clinical trial is to find out whether 12 months of treatment with the SGLT2 inhibitor Forxiga® (dapagliflozin 10 mg once daily), compared with placebo, can reduce the risk of developing post-transplant diabetes…
- Conditions
- Kidney Transplant Recipient, Sodium Glucose Co-Transporter 2 Inhibitors, Non-Diabetic Patients, Randomized Controlled Trial (RCT)
- Trial name
- SGL-TX-PTDM (NCT07682350)
- Testing
- SGLT2i
- Where
- 3 sites in Denmark
- Volunteers
- 184 people
- Sponsor
- Odense University Hospital
Hysteroscopy, Assessment Methods in Medical Training
Assessment of Hysteroscopy Skills With a New Assessment Tool
Objective To investigate validity of the hysteroscopy assessment tool (HYSAT) for assessment of competence in a clinical environment.
- Conditions
- Hysteroscopy, Assessment Methods in Medical Training, Medical Education, Diagnostic Hysteroscopy
- Trial name
- NCT07672288
- Testing
- Evaluation score based on assessment tool
- Where
- 2 sites in Canada, Denmark
- Volunteers
- 24 people
- Sponsor
- Odense University Hospital
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
Postoperative Cognitive Dysfunction (POCD), Cognitive Change
Early Cognitive Changes After Same-day Discharge Hip and Knee Arthroplasty
The goal of this observational study is to explore early cognitive changes in patients aged 70 years or older undergoing same-day discharge after hip or knee replacement surgery.
- Conditions
- Postoperative Cognitive Dysfunction (POCD), Cognitive Change, Total Knee Arthroplasty, Unicompartmental Knee Arthroplasty
- Trial name
- NCT07598552
- Where
- Denmark
- Volunteers
- 48 people
- Sponsor
- Odense University Hospital
Diabetes Mellitus, Pregnancy Complications
Educational TOolS for Pregnant Women With Diabetes Mellitus
A randomized controlled trial evaluating whether a patient-centered virtual educational tool based on small videos focusing on optimization of mental health, diet, physical activity, self-adjustment of insulin dose and use of…
- Trial name
- ETOS-DM (NCT06250192)
- Testing
- Video-based education
- Where
- Denmark
- Volunteers
- 621 people
- Sponsor
- Odense University Hospital
Prostate Cancer, Oligo-metastatic Prostate Carcinoma
MR-guided Single-fraction SBRT for Nodal Oligorecurrent Prostate Cancer (PINPOINT)
This single-arm phase 2 trial investigates whether a single high-dose radiotherapy treatment can safely treat men whose prostate cancer has come back in a small number of lymph nodes in the pelvis or abdomen after curative…
- Conditions
- Prostate Cancer, Oligo-metastatic Prostate Carcinoma, Oligometastatic Cancer, Nodal Oligorecurrent Prostate Cancer
- Trial name
- PINPOINT (NCT07635108)
- Testing
- Single-fraction SBRT
- Where
- Denmark
- Volunteers
- 48 people
- Sponsor
- Odense University Hospital
Lung Cancer, Peripheral Lung Lesions
Diagnosing peRipheral Lung Lesions With CRYO Biopsies
Lung cancer is the leading course of cancer related deaths world-wide. Lung cancer screening will increase the number of small lung lesion in need of biopsy to confirm the diagnosis.
- Trial name
- DR CRYO (NCT06844344)
- Testing
- forceps biopsies, Cryo biosies
- Where
- 2 sites in Denmark
- Volunteers
- 100 people
- Sponsor
- Odense University Hospital
Hypo- and Hyperglycemia Following Bariatric Surgery, Association Between Glucose Excursions, Fetal Growth and Neonatal Body Composition
The BAMBI II Study
Background Bariatric surgery (BS) is an efficient treatment of severe obesity and diseases like female infertility. Almost half of the population having BS are women of reproductive age, and BMI above 35 kg/m2 and infertility…
- Trial name
- NCT07578597
- Testing
- CGM, Activity tracker, Blood samples
- Where
- Denmark
- Volunteers
- 225 people
- Sponsor
- Odense University Hospital
Gestational Diabetes Mellitus (GDM), Type 2 Diabetes (T2DM)
Women With Previous GDM and the Effects of HIIT.
The goal of this clinical trial is to investigate if women with previous gestational diabetes (pGDM) are characterized with unique metabolic and molecular alterations compared to women without pGDM.
- Conditions
- Gestational Diabetes Mellitus (GDM), Type 2 Diabetes (T2DM), High-intensity Interval Training
- Trial name
- GDM-HIIT (NCT07566845)
- Testing
- High-intensity interval training
- Where
- Denmark
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Odense University Hospital
Physical Disability, Physical Activity
Frame Running for Exercise and Participation for Children and Young People With Physical Disabilities
The goal of this quasi-experimental single-arm trial is to evaluate whether a structured Frame Running training program can improve functional ability, participation, and quality of life in children and young people with physical…
- Conditions
- Physical Disability, Physical Activity, Physical Function, Quality of Life
- Trial name
- FRAME-EX (NCT07543614)
- Testing
- Frame Running Training
- Where
- Denmark
- Volunteers
- 35 people
- Sponsor
- Odense University Hospital
Ankle Fracture, Rehabilitation
Bracing After Ankle Fracture
Ankle fractures are common, debilitating and usually treated with immobilisation using a foot-ankle brace (walker). Emerging evidence suggests that a less restrictive brace may reduce recovery time without increasing the risk of…
- Conditions
- Ankle Fracture, Rehabilitation, Recovery
- Trial name
- BAF (NCT07163091)
- Testing
- ankel stirrup, Foot-ankel brace (walker)
- Where
- 16 sites in Denmark, Faroe Islands
- Volunteers
- 1,400 people
- Sponsor
- Odense University Hospital
Acute Respiratory Disease
Positioning of Children With Acute Respiratory Insufficiency
Acute respiratory insufficiency is one of the most common causes of hospitalization and death among young children. It often affects small children who, due to infections with RSV (respiratory syncytial virus), other cold…
- Trial name
- NCT07170085
- Testing
- positioning
- Where
- Denmark
- Volunteers
- 40 people
- Sponsor
- Odense University Hospital
Back Pain Lower Back Chronic, Insomnia
Melatonin fOr CHronic bAck Pain (The MOCHA Trial)
According to the World Health Organization (WHO) Global Burden of Disease study, back pain is one of the conditions impacting disability the most worldwide.Pain medication use in patients with chronic back pain is substantial…
- Trial name
- MOCHA (NCT06476392)
- Testing
- Melatonin 10 MG
- Where
- Denmark
- Volunteers
- 220 people
- Sponsor
- Odense University Hospital
Chronic Pain, Insomnia
Digital CBT-I for Patients With Chronic Pain and Insomnia
Chronic pain constitutes an increasing health and social burden. More than 50% of patients with chronic pain report insomnia, and patients with comorbid insomnia often report stronger and widespread pain, compared to those who…
- Trial name
- Back2Sleep (NCT06361914)
- Testing
- Digital CBT-I, Digital Sleep hygiene education
- Where
- Denmark
- Volunteers
- 140 people
- Sponsor
- Odense University Hospital
Breast Cancer Detection
FAP PET/CT for Staging Patients With Breast Cancer
This study aims to evaluate the clinical utility of [68Ga]Ga-FAP-2268 PET/CT for disease staging and assessment in patients with high-risk primary breast cancer.
- Trial name
- NCT07523607
- Testing
- 68Ga-FAP-2286
- Volunteers
- 65 people
- Sponsor
- Odense University Hospital
Diabetes Distress, Diabetes Mellitus Type 1
Type 1 Diabetes and Diabetes Distress
The goal of this clinical trial is to reduce diabetes distress in emerging adults (18-35 years) with type 1 diabetes and moderate-to-severe diabetes distress.
- Trial name
- ACTnow (NCT06936280)
- Testing
- ACTnow
- Where
- 3 sites in Denmark
- Volunteers
- 100 people
- Sponsor
- Odense University Hospital
Postmenopausal Women
Everolimus and/or Exercise to Prevent Bone Loss in Postmenopausal Women
It is estimated that women lose around 20-25% of bone mass during the 5-10 years period of postmenopausal transition, and menopause is considered a major risk factor for osteoporotic fragility fracture.
- Trial name
- RapaLoad (NCT06789900)
- Testing
- Everolimus (Afinitor®), Football Fitness Concept
- Where
- Denmark
- Volunteers
- 136 people, healthy volunteers welcome
- Sponsor
- Odense University Hospital
Calciphylaxis, Calcific Uremic Arteriolopathy
Calciphylaxis in Patients With Chronic Kidney Disease - A Study of the Danish Calciphylaxis Research Initiative (DanCaRI)
Calciphylaxis is a rare yet life-threatening condition involving pronounced calcification in small blood vessels of the skin. Knowledge about its underlying mechanisms and contributing risk factors remains limited.
- Conditions
- Calciphylaxis, Calcific Uremic Arteriolopathy, End Stage Renal Disease (ESRD), Chronic Kidney Diseases
- Trial name
- NCT07511283
- Where
- Denmark
- Volunteers
- 860 people, healthy volunteers welcome
- Sponsor
- Odense University Hospital
Healthy, Osteopenia
Resistance Training and Rapamycin to Enhance Bone Formation in Postmenopausal Women
The aim of the present clinical trial is to examine the effects of everolimus, resistance training, or their combination on bone and muscle health formation in elderly women aged 60-75 years.
- Conditions
- Healthy, Osteopenia, Osteoporosis Risk
- Trial name
- StrongBone (NCT07191353)
- Testing
- Everolimus, Resistance training
- Where
- 2 sites in Denmark
- Volunteers
- 148 people, healthy volunteers welcome
- Sponsor
- Odense University Hospital
Colorectal Cancer
Camera Capsule Endoscopy in the Routine Diagnostic Pathway for Colorectal Diseases
The Department of Surgery at Odense University Hospital (OUH) carries out approximately 10,000 colonoscopies each year, and this number is continuously increasing.
- Trial name
- DanCap (NCT06475560)
- Testing
- CCE arm, CC arm
- Where
- Denmark
- Volunteers
- 800 people
- Sponsor
- Odense University Hospital