Clinical trials: active, 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
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
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
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
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
Cardiovascular Diseases
Proactive Population Health Management of Cardiovascular Disease in Primary Care Using the PROSPERA-program.
The PROSPERA-program is a complex multilevel approach that includes training for healthcare providers, a risk assessment process, and decision support tools to help match patients with the appropriate treatment based on their…
- Trial name
- PROSPERA (NCT06593704)
- Testing
- PROSPERA-program
- Where
- Netherlands
- Volunteers
- 848 people
- Sponsor
- Leiden University Medical Center
Venous Thromboembolism, Venous Thromboses
inDividual, Targeted thrombosIS Prophylaxis Versus the Standard 'One Size Fits All' Approach in Patients Undergoing Total hIp or Total kNee replaCemenT
After hip or knee replacement all patients receive a standardized treatment with blood thinners, this medication is called thrombosis prophylaxis.
- Conditions
- Venous Thromboembolism, Venous Thromboses, Pulmonary Embolism, Deep Vein Thrombosis
- Trial name
- DISTINCT (NCT06581965)
- Testing
- Short duration prophylaxis, Higher intensity and longer duration prophylaxis, Control
- Where
- 13 sites in Netherlands
- Volunteers
- 10,078 people
- Sponsor
- Leiden University Medical Center
Adverse Drug Reaction
Personalised Therapeutics @LUMC
In PT@LUMC 2000 patients will be randomized between a PGx-guided dosing group and a standard of care group. The patients will be followed for one year in which they will be asked to report adverse drug reactions at one, three…
- Trial name
- PT@LUMC (NCT05508763)
- Testing
- Genetic test for 14 pharmacogenes
- Where
- Netherlands
- Volunteers
- 2,000 people
- Sponsor
- Leiden University Medical Center
Type 1 Diabetes
Making Diabetes Care Fit for Young Adults Living With Type 1 Diabetes: Observations, Reflections and Expert Opinions
The goal of this clinical study is to assess differences in collaborative efforts to make care fit between clinical encounters in usual care and those using the Making Care Fit tool among young adults with type 1 diabetes and…
- Trial name
- NCT07498738
- Testing
- Making Care Fit tool, Care as usual
- Where
- 2 sites in Netherlands
- Volunteers
- 60 people
- Sponsor
- Leiden University Medical Center
Longevity, Familial Longevity
Longevity Families of the Netherlands
The demographic life expectancy enhancement of the past 150 years imposes an urgent challenge in Western and economically growing societies to stimulate the healthy lifespan that is lagging behind.
- Conditions
- Longevity, Familial Longevity, Extreme Longevity, Aging
- Trial name
- LOF-NL (NCT06374069)
- Where
- Netherlands
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Leiden University Medical Center
Glioma
Seizure Treatment in Glioma
Currently, treatment with a specific anti-epileptic drug mainly depends on the physicians' preference, as there are no studies supporting the use of one specific anticonvulsant in glioma patients.
- Trial name
- STING (NCT03048084)
- Testing
- Levetiracetam, Valproic Acid
- Where
- 5 sites in Netherlands
- Volunteers
- 120 people
- Sponsor
- Leiden University Medical Center
Aneurysm Abdominal, Cerebral Aneurysm Ruptured
Occurrence of Abdominal Aortic Aneurysms in Patients With Aneurysmal Subarachnoid Hemorrhage
Rationale: Aneurysms of different types are known to be associated. In literature, concurrence of intracranial- and aortic aneurysms is described.
- Trial name
- TRACE-aSAH (NCT07312565)
- Where
- Netherlands
- Volunteers
- 233 people
- Sponsor
- Leiden University Medical Center
Chronic Cluster Headache
Efficacy, Safety and Tolerability of Low Sodium Oxybate for Nocturnal Cluster Headache Attacks
The goal of this clinical trial is to evaluate the efficacy of low sodium oxybate (LXB) (brand name Xywav) in the treatment of (nocturnal) cluster headache attacks in subjects with chronic cluster headache.
- Trial name
- SUNCET (NCT06950281)
- Testing
- Low Sodium Oxybate
- Volunteers
- 52 people
- Sponsor
- Leiden University Medical Center
Infant, Premature, Diseases, Birth, Preterm
The NEU - CAP Trial
The aim of NEU-CAP is to investigate the clinical impact of using a colorimetric carbon dioxide (CO₂) detector during non-invasive ventilation (NIV). Infants born before 32 weeks of gestation will be included in this trial.
- Conditions
- Infant, Premature, Diseases, Birth, Preterm, Respiratory Distress Neonatal
- Trial name
- NEU-CAP (NCT07754032)
- Testing
- Local standard care of monitoring non-invasive ventilation, CO₂-guided Non-Invasive Ventilation
- Volunteers
- 1,860 people
- Sponsor
- Leiden University Medical Center
Pilot Study
How Differences in the Composition of Microorganisms in the Soil Affect the Microorganisms in the Human Gut, Through the Vegetables That Grow in it: a Process Pilot Study With Healthy Participants
There are two objectives for this clinical trial. The first is to test whether, with the current logistics and study setup it is possible to perform the study well and see where there might be bottlenecks we couldn't predict.
- Trial name
- HUMANITAS (NCT07742319)
- Testing
- Low diversity vegetable smoothie, High diversity vegetable smoothie
- Where
- Netherlands
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Leiden University Medical Center
Leakage, Anastomotic, Colon Cancer
COLOFLOW: Laser Speckle Contrast Imaging Versus Near-infrared Fluorescence Imaging With Indocyanine Green
COLOFLOW is a prospective observational study investigating whether Laser Speckle Contrast Imaging (LSCI), a dye-free and objective perfusion imaging technique, corresponds with the currently used subjective assessment of…
- Conditions
- Leakage, Anastomotic, Colon Cancer, Colon Anastomosis, Colon and Rectal Cancer
- Trial name
- COLOFLOW (NCT07720505)
- Testing
- Laser Speckle Contrast Imaging
- Volunteers
- 30 people
- Sponsor
- Leiden University Medical Center
Acute Stroke, MRI Imaging
Low-Field MRI in Stroke Code Patients
This study evaluates the accuracy and feasibility of a portable low-field MRI (Hyperfine) device in patients presenting to the emergency department with suspected acute stroke.
- Trial name
- LFMIS (NCT07702968)
- Testing
- Low-field MRI
- Where
- Netherlands
- Volunteers
- 80 people
- Sponsor
- Leiden University Medical Center
Myasthenia Gravis, Fatigue
Interventions Against Fatigue in Patients With Myasthenia Gravis
A prospective assessor-blinded randomized clinical trial investigating the effect of aerobic exercise therapy or cognitive behavioural therapy on fatigue in patients with myasthenia gravis.
- Trial name
- FIT to ACT-MG (NCT06659627)
- Testing
- Aerobic exercise therapy, Cognitive behavioural therapy, Usual care
- Where
- Netherlands
- Volunteers
- 60 people
- Sponsor
- Leiden University Medical Center
Myasthenia Gravis, Fatigue
Capturing Key MG-symptoms Using Smartphone Recordings.
This study will make use of a cross-sectional design of MG patients and non-MG participants to quantitatively assess key MG symptoms, and to explore the applicability of machine learning algorithms to their measurement.
- Trial name
- CAPTURE - MG (NCT06743490)
- Where
- 2 sites in Netherlands
- Volunteers
- 225 people, healthy volunteers welcome
- Sponsor
- Leiden University Medical Center