Clinical trials: sponsored by Leiden University Medical Center
Liver Disease (Alcoholic or Not), Transplantation
In-situ vs Ex-situ Liver Preservation
The goal of this Randomized Controlled Trial is to learn what machine preservation method is most clinically effective for liver transplantation (LTx) after donation after circulatory death (DCD).
- Trial name
- INSPIRE-NL (NCT07899853)
- Testing
- In-situ perfusion: aNRP, Ex-situ perfusion: DHOPE/DHOPE-COR-NMP
- Where
- 3 sites in Netherlands
- Volunteers
- 752 people
- Sponsor
- Leiden University Medical Center
Knee Osteoarthritis
The Effect of Theory-driven Physiotherapy on Physical Activity in Knee OA.
Knee osteoarthritis (OA) is a leading cause of pain, disability, and reduced physical functioning worldwide. Although physiotherapy and physical activity are recommended as first-line treatments, many individuals with knee OA do…
- Trial name
- EXPLOR (NCT07901881)
- Testing
- EXPLOR-3
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- Mark van Loo
Pulmonary Embolism Acute
Reduced-Dose Versus Full-Dose Alteplase for High-Risk Pulmonary Embolism
High-risk pulmonary embolism is a life-threatening condition requiring immediate reperfusion therapy. Full-dose systemic thrombolysis is recommended as first-line treatment, but its use is limited by the risk of major bleeding…
- Trial name
- REDSTEM (NCT07816978)
- Testing
- Reduced-dose alteplase, Full-dose alteplase
- Where
- 23 sites in Denmark, Norway and 1 more
- Volunteers
- 400 people
- Sponsor
- Sahlgrenska University Hospital
Empyema, Pleural, Pleural Infections
VATS or Intrapleural Enzymatic Therapy for Patients With Empyema.
A parapneumonic pleural infection is a frequently encountered and serious medical emergency with high morbidity and mortality in specific patient groups (especially in the elderly and immunocompromised).
- Trial name
- VIETS (NCT07886541)
- Testing
- VATS group, IET
- Where
- Netherlands
- Volunteers
- 164 people
- Sponsor
- Amsterdam UMC
Reconstructive Surgery, Flap Monitoring
Flap Assessment With Regional Oximetry for Early Detection of Compromise in Free Flap Reconstructive Surgery - FLARE Study
After some operations in which tissue is removed, it is necessary to repair the defect with a piece of tissue from another location in the body.
- Trial name
- FLARE (NCT07887256)
- Testing
- Elective free flap surgery, INVOS monitoring
- Where
- 3 sites in Netherlands
- Volunteers
- 100 people
- Sponsor
- Leiden University Medical Center
Ovarian Cancer, Ovarian Tumor
AI Analysis of CT Scans to Classify Ovarian Tumours as Benign, Borderline or Malignant Before Surgery
The goal of this observational study is to learn if a computer program can tell what type of ovarian tumour a person has from a CT scan taken before surgery. The program uses artificial intelligence (AI).
- Conditions
- Ovarian Cancer, Ovarian Tumor, Borderline Ovarian Tumor
- Trial name
- OvaClass (NCT07883551)
- Where
- 7 sites in Belgium, Netherlands
- Volunteers
- 1,300 people
- Sponsor
- Catharina Ziekenhuis Eindhoven
Endometrial Cancer
Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER
This protocol tests de-escalated adjuvant treatment in patients with POLE-mutated or p53wt/NSMP (p53 wildtype/no specific molecular profile) early-stage endometrial cancer (EC).
- Trial name
- NCT05640999
- Testing
- Vaginal brachytherapy, Adjuvant radiotherapy (EBRT +/- brachytherapy), Observation
- Where
- 123 sites in United States, Australia and 7 more
- Volunteers
- 393 people
- Sponsor
- Canadian Cancer Trials Group
Astrocytoma, Ependymoma
Proton Therapy Research Infrastructure- ProTRAIT- Neuro-oncology
The first proton therapy treatments in the Netherlands have taken place in 2018. Due to the physical properties of protons, proton therapy has tremendous potential to reduce the radiation dose to the healthy, tumour-surrounding…
- Conditions
- Astrocytoma, Ependymoma, Ganglioglioma, Oligodendroglioma
- Trial name
- NCT04648462
- Testing
- ProTRAIT
- Where
- 3 sites in Netherlands
- Volunteers
- 1,500 people
- Sponsor
- Maastricht Radiation Oncology
Locally Advanced Pancreatic Carcinoma (LAPC)
Surgery Versus Stereotactic Ablative Radiotherapy for Patients With Locally Advanced Pancreatic Cancer With Favourable Biological Response Following Induction Chemotherapy
The primary objective of this study is to assess the added value of surgical exploration with intention for resection compared to MRI guided stereotactic ablative radiotherapy (SABR) in improving overall survival in patients with…
- Trial name
- PREOPANC-4 RCT (NCT07867873)
- Testing
- Pancreatic surgery, MRI guided stereotactic ablative radiotherapy
- Volunteers
- 230 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Acromegaly Due to Pituitary Adenoma, Hyperglycemia
Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
Rationale: Pasireotide is a second line medical treatment for acromegaly that can add value for patients with insufficient control of disease on 1st generation SRL, or 1st generation SRL + pegvisomant.
- Conditions
- Acromegaly Due to Pituitary Adenoma, Hyperglycemia, Ketogenic Diet, Standard Care Control
- Trial name
- PasiAcroKeto (NCT07866846)
- Testing
- Ketogenic diet, Diabetes Medication
- Where
- Netherlands
- Volunteers
- 30 people
- Sponsor
- Leiden University Medical Center
Endometrial Cancer
Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features
RAINBO MMRd-GREEN is an international, multicenter, phase III randomised trial wherein adjuvant pelvic external beam radiotherapy combined with and followed by durvalumab for one year is compared to adjuvant pelvic external beam…
- Trial name
- RAINBO-GREEN (NCT05255653)
- Testing
- Pelvic external beam radiotherapy, Chemotherapy, Durvalumab
- Where
- 60 sites in Belgium, Canada and 5 more
- Volunteers
- 316 people
- Sponsor
- Leiden University Medical Center
Lupus Erythematosus, Systemic
Synergetic B-cell Immunomodulation in SLE - 2nd Study.
In follow-up of the previous SynBioSe Study the present study is a randomized controlled trial designed to further investigate the long-term clinical and imunological efficacy of combination B-cell targeting by starting treatment…
- Trial name
- SynBioSe-2 (NCT03747159)
- Testing
- Belimumab Injection
- Where
- 4 sites in Netherlands
- Volunteers
- 71 people
- Sponsor
- Leiden University Medical Center
Rheumatoid Arthritis
MethMax Trial: MAXimising the METHotrexate Therapy Potential in Patients With Active Rheumatoid Arthritis
The MethMax trial is a prospective, international, multicentre, randomised, assessor-blinded, parallel-group, low intervention study.
- Trial name
- MethMax (NCT06649136)
- Testing
- Methotrexate
- Where
- Austria
- Volunteers
- 182 people
- Sponsor
- Medical University of Vienna
Non Small Cell Lung Cancer, Immunotherapy
RADICAL-IO: thRee Cycles of immunotherApy Without raDical Therapy In mediCALly InOperable Stage I Non-small Cell Lung Cancer
Traditionally, chemotherapy and/or immunotherapy are combined with surgery or radiotherapy to cure patients with lung cancer. However, some patients treated with immunotherapy appear to be cured before surgery or radiotherapy.
- Trial name
- RADICAL-IO (NCT07808138)
- Testing
- Cemiplimab 350 mg IV
- Where
- 2 sites in Netherlands
- Volunteers
- 30 people
- Sponsor
- The Netherlands Cancer Institute
Constipation, Opioid-Induced
Prevention of Opioid-induced Constipation in Patients With Advanced Cancer
More than 70% of patients with cancer in the palliative phase have pain that often requires treatment with opioids (morphine-like agents). Constipation occurs in 59% of patients treated with opioids.
- Trial name
- OMAMA (NCT05216328)
- Testing
- Macrogol Only Product in Oral Dose Form, Magnesium hydroxide 724mg
- Where
- 13 sites in Netherlands
- Volunteers
- 258 people
- Sponsor
- Amsterdam UMC, location VUmc
Fasting, Dietary Fibre
Combining Fasting and Fibre Interventions to Optimise Their Gut Microbiome-mediated Health Benefits
This study builds on the knowledge that fasting provides metabolic health benefits and that prebiotic interventions can enhance the gut microbiome's metabolic output to likewise improve host health.
- Conditions
- Fasting, Dietary Fibre, Gut Microbiome, Metabolism Changes
- Trial name
- CoFFIe (NCT07691736)
- Testing
- Fibre Arm, Control Arm
- Where
- Germany
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Buchinger Wilhelmi Development & Holding GmbH
Wheezing, LRTI
Protecting Preterm Infants From Respiratory Tract Infections and Wheeze by Using Bacterial Lysates.
The primary objective of this study is to reduce respiratory tract infections and wheezing in moderate-late preterms in the first years of life by bacterial lysate administration.
- Conditions
- Wheezing, LRTI, Premature
- Trial name
- PROTEA (NCT05063149)
- Testing
- Broncho-Vaxom
- Where
- Netherlands
- Volunteers
- 500 people
- Sponsor
- Franciscus Gasthuis
Vascular Disease，Peripheral
SPECTATOR: Perfusion Monitoring Before, During and After Lower Extremity Revascularization With Laser Speckle Contrast Imaging
This study aims to evaluate the feasibility of Laser Speckle Contrast Imaging for perioperative perfusion assessment of the lower extremity before, during, and after revascularization.
- Trial name
- SPECTATOR (NCT07558174)
- Testing
- Laser Speckle Contrast Imaging
- Where
- Netherlands
- Volunteers
- 30 people
- Sponsor
- Leiden University Medical Center
Cardiometabolic Diseases, Postmenopause
Exercise and Prolonged Fasting to Improve Brown Adipose Tissue Function in Postmenopausal Women
Type of Study: Clinical Trial Goal: The goal of this clinical trial is to investigate mitochondrial function in interscapular brown adipose tissue (iBAT) in postmenopausal women and determine whether aerobic exercise, prolonged…
- Trial name
- EMPOWER-BAT (NCT07837752)
- Testing
- Aerobic exercise, Prolonged fasting
- Where
- Spain
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Universidad de Almeria
Kidney Transplant Rejection
Belimumab to Mobilise Memory B-cells From Secondary Lymhoid Organs to Improve Memory B-cell HLA-specificity Profiling to Support Delisting for Transplant Access in Highly-sensitized
The goal of this clinical trial is to determine whether belimumab can improve detection of circulating HLA-specific memory B cells to support safer and more effective donor organ allocation in highly sensitized kidney transplant…
- Trial name
- BE-MOBILYZED (NCT07539857)
- Testing
- Belimumab Prefilled Syringe [Benlysta]
- Where
- Netherlands
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Leiden University Medical Center