Clinical trials: sponsored by University Medical Center Groningen
Peyronie's Disease
Assessment of the Value of FAPI and FDG-PET-CT in Diagnosis of Acute Phase Peyronie's Disease
The goal of this clinical trial is to learn if FAPI-PET/CT and/or FDG-PET/CT scan is able to detect active fibroblast tissue and inflammation in patients with acute or chronic phase PD.
- Trial name
- Hippocrates (NCT07903987)
- Testing
- 68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor)
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- University Medical Center Groningen
End-stage Liver Disease (ESLD), Acute Liver Failure
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
Machine perfusion (MP) has become routine clinical practice in liver transplantation. However, as the field has matured, direct randomized comparisons between distinct MP modalities have become increasingly impractical, given…
- Conditions
- End-stage Liver Disease (ESLD), Acute Liver Failure, Liver Cirrhosis, Liver Transplantation
- Trial name
- REFRAME-MP (NCT07585890)
- Testing
- Endischemic hypothermic oxygenated machine perfusion (any device), Endischemic (back-to-base) normothermic machine perfusion (any device), Continuous (device-to-donor) normothermic machine perfusion (any device)
- Where
- 37 sites in Austria, Belgium and 8 more
- Volunteers
- 10,000 people
- Sponsor
- University Medical Center Groningen
Type 1 Diabetes Mellitus With Diabetic Nephropathy
dApagliflozin SC0062 and Prevention of Renal Injury; a Randomized Evaluation
The aim of this study is to test the hypothesis that dapagliflozin (SGLT2 inhibitor) and SC0062 (ERA) combination therapy augments nephroprotection and mitigates fluid retention and ketogenesis in people with T1D through…
- Trial name
- ASPIRE-1 (NCT06072326)
- Testing
- Dapagliflozin (Forxiga®), SC0062 strength 10mg, SC0062 and dapagliflozin
- Where
- 5 sites in Denmark, Finland
- Volunteers
- 36 people
- Sponsor
- University Medical Center Groningen
Oropharyngeal Carcinoma
Off-line Adaptive Proton Therapy
This prospective in-silico study evaluates a novel Off-line Adaptive Proton Therapy (o-APT) workflow for patients with oropharyngeal cancer receiving proton therapy.
- Trial name
- o-APT (NCT07866547)
- Testing
- Off-line Adaptive Proton Therapy (o-APT) Workflow Evaluation
- Where
- Netherlands
- Volunteers
- 100 people
- Sponsor
- University Medical Center Groningen
Kidney Disease, Chronic, Renal Transplant Failure
The RENAL LIFECYCLE Trial: A RCT to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Severe CKD
Rationale: Sodium glucose co transporter 2 (SGLT2) inhibitors are a relatively new class of agents, originally developed as oral antihyperglycemic drugs.
- Conditions
- Kidney Disease, Chronic, Renal Transplant Failure, Heart Failure, Kidney Failure
- Trial name
- NCT05374291
- Testing
- Dapagliflozin 10 mg/day (oral)
- Where
- 101 sites in Australia, Belgium and 4 more
- Volunteers
- 1,750 people
- Sponsor
- University Medical Center Groningen
NHL, DLBCL - Diffuse Large B Cell Lymphoma
Comparison of Point-of-care Produced CAR T-cell With Commercial CAR T-cells in Patients With R/R LBCL
A phase II, multi-center study to compare the feasibility, and clinical efficacy of local manufacturing of CD19-directed CAR T-cells (ARI-0001 CAR T-cells) with commercial produced CAR T-cells (for example axicabtagene…
- Trial name
- HOVON161 (NCT05641428)
- Testing
- ARI-0001, Axi-cel
- Where
- 7 sites in Netherlands
- Volunteers
- 340 people
- Sponsor
- University Medical Center Groningen
Atrial Fibrillation
EHRA-PATHS: Clinical and Health Economic Evaluation of New Care Pathways
In elderly atrial fibrillation (AF) patients, AF is usually a manifestation of risk factors and comorbidities not only limited to cardiovascular diseases. Especially in elderly often more than two comorbidities are present.
- Trial name
- EHRA-PATHS (NCT05773768)
- Testing
- EHRA-PATHS software tool
- Where
- Netherlands
- Volunteers
- 703 people
- Sponsor
- University Medical Center Groningen
Chronic Kidney Disease
Optimizing Albuminuria Treatment in CKD With Finerenone and Semaglutide
The FINESSE-CKD trial investigates a personalized approach to the treatment of chronic kidney disease (CKD) by comparing the effects of finerenone and semaglutide on albuminuria.
- Trial name
- FINESSE-CKD (NCT07819227)
- Testing
- Finerenone (BAY 94-8862), Semaglutide 14 MG [Rybelsus], Finerenone and Semaglutide
- Where
- 6 sites in Denmark, Italy and 2 more
- Volunteers
- 41 people
- Sponsor
- University Medical Center Groningen
Noninvasive Ventilation
The Effects of Nocturnal Non-invasive Ventilation in Stable COPD
Rationale: Application of long-term non-invasive ventilation (NIV) in chronic obstructive pulmonary disease (COPD) patients with chronic hypercapnic respiratory failure (CHRF) has recently been shown to improve outcomes.
- Trial name
- RECAPTURE (NCT03053973)
- Testing
- nocturnal noninvasive ventilation, Standard Care
- Where
- Netherlands
- Volunteers
- 116 people
- Sponsor
- University Medical Center Groningen
Asthma (Diagnosis), Inhaler Technique
Using a Digital Spacer for Inhaler Technique Education in Pediatric Asthma
This pilot study evaluates the feasibility, usability, and potential effect of the aflo™ Smart Spacer platform in children aged 6-18 with uncontrolled asthma using pMDIs and spacers.
- Conditions
- Asthma (Diagnosis), Inhaler Technique, Pediatric Asthma
- Trial name
- INSPIRE-KIDS (NCT07803042)
- Testing
- Aflo™ Smart Spacer
- Where
- Netherlands
- Volunteers
- 12 people
- Sponsor
- University Medical Center Groningen
ADPKD
HYDROchlorothiazide to PROTECT Polycystic Kidney Disease Patients and Improve Their Quality of Life
Autosomal dominant polycystic kidney disease (ADPKD) is characterized by progressive formation of renal cysts which ultimately lead to a loss of renal function.
- Trial name
- HYDRO-PROTECT (NCT05373264)
- Testing
- Hydrochlorothiazide 25 mg
- Where
- 25 sites in Austria, Belgium and 5 more
- Volunteers
- 300 people
- Sponsor
- University Medical Center Groningen
Head and Neck Cancer
Predictive Models for Radiation-induced Side Effects in Head and Neck Cancer Based on Single Nucleotide Polymorphisms (SNP)
Background of the study: Swallowing dysfunction and xerostomia are the most frequently reported radiation-induced side effects (RISE) after (chemo) radiation ((CH) RT) in head and neck cancer (HNC) patients and have a major…
- Trial name
- HANS (NCT02489084)
- Testing
- Blood sampling
- Where
- Netherlands
- Volunteers
- 2,000 people
- Sponsor
- University Medical Center Groningen
Pituitary Tumor, Visual Fields Hemianopsia
Perimetry Based on Eye-movements in Patients With (Supra)Sellar Tumors
The purpose of this study is to assess wether the SONDA visual field test is suitable for patients with a supra sellar tumour.
- Trial name
- NCT06266949
- Testing
- SONDA
- Where
- Netherlands
- Volunteers
- 30 people
- Sponsor
- University Medical Center Groningen
Microtia, Congenital, Auricular Reconstruction
Social Perception of Microtia
Rationale: Microtia is a congenital craniofacial condition characterized by the underdevelopment of the external ear. Children with microtia become aware of their deformity at a young age, and this awareness intensifies in…
- Trial name
- NCT07721805
- Where
- Netherlands
- Volunteers
- 1,271 people, healthy volunteers welcome
- Sponsor
- University Medical Center Groningen
COPD
Respiratory Muscles in End-stage Lung Disease: Pathophysiological Processes & Clinical Consequences
Rationale: In patients with chronic lung diseases, the role of respiratory muscle dysfunction has been underestimated. Also, current treatment options, like chronic NIV and lung transplantation (LTx), might also have deleterious…
- Trial name
- Re-MAP (NCT06935825)
- Where
- 4 sites in Netherlands
- Volunteers
- 60 people
- Sponsor
- University Medical Center Groningen
Myalgic Encephalomyelitis / Chronic Fatigue Syndrome
PEM, a Starting Point to Investigate ME/CFS
Exercise is an important contributor to general health and is considered a potential remedy for chronic diseases. This is in strong contrast with the observation that in most myalgic encephalomyelitis (ME/CFS) patients exercise…
- Trial name
- PEM_CFS (NCT07715838)
- Testing
- No intervention is planned
- Where
- Netherlands
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University Medical Center Groningen
Tuberculosis
A Phase I Study Investigating the Local Tolerability and Pharmacokinetics of Isoniazid (INH) Inhalation by Wet Nebulization in Patients With Tuberculosis
Rationale: To halt the global tuberculosis (TB) crisis, and particular the ongoing threat of drug-resistant TB (DR-TB), it is essential to reduce transmission.
- Trial name
- INHalation-01 (NCT07708779)
- Testing
- Isoniazid
- Where
- Netherlands
- Volunteers
- 8 people
- Sponsor
- University Medical Center Groningen
Metastatic Triple Negative Breast Cancer, Metastatic Testicular Cancer
The TASTY-steering Study
This is a multicentre non-blinded randomised intervention trial with a parallel cluster design. The multicentre study will be performed at 12 hospitals in the Netherlands.
- Conditions
- Metastatic Triple Negative Breast Cancer, Metastatic Testicular Cancer, Stage II-IV Diffuse Large B Cell Lymphoma
- Trial name
- TASTY-steering (NCT07258563)
- Testing
- Taste steering
- Where
- 11 sites in Netherlands
- Volunteers
- 201 people
- Sponsor
- University Medical Center Groningen
Stage III Non-small Cell Lung Cancer, Unresectable Stage III NSCLC
In Vivo Fluorescence Molecular Bronchoscopy of Durvalumab-680LT in Patients With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) After Chemoradiotherapy
PulmoPrint is a clinical study at the University Medical Center Groningen (UMCG) that investigates why some patients with unresectable stage III lung cancer don't respond to immunotherapy after chemoradiotherapy.
- Trial name
- PulmoPrint (NCT07653438)
- Testing
- Fluorescence molecular imaging during bronchoscopy with durvalumab-680LT
- Volunteers
- 20 people
- Sponsor
- University Medical Center Groningen
Oncological Patients, Tyrosine Kinase Inhibitor
The TASTY-training Study
A multicentre non-blinded randomised intervention trial with a parallel cluster design. The multicentre study will be performed at 12 hospitals in the Netherlands.
- Trial name
- TASTY-training (NCT07258589)
- Testing
- Taste and smell training
- Where
- 11 sites in Netherlands
- Volunteers
- 90 people
- Sponsor
- University Medical Center Groningen