Clinical trials: sponsored by UMC Utrecht
HIV/AIDS
The Intensified Treatment Monitoring Strategy to Prevent Accumulation of Drug Resistance (ITREMA) Trial
The ITREMA trial is an open-label randomized controlled trial (RCT) in which HIV-1 infected patients initiating first-line ART and already on first-line ART will be enrolled.
- Trial name
- ITREMA (NCT03357588)
- Testing
- Intensified monitoring, Standard of care monitoring
- Where
- South Africa
- Volunteers
- 501 people
- Sponsor
- UMC Utrecht
Rheumatoid Arthritis
Tolerogenic Dendritic Cell Therapy for Rheumatoid Arthritis
Rationale: In rheumatoid arthritis, immune cells cause joint inflammation and destruction in response to autoantigens. Immunosuppressive therapies offer relief but fail to induce tolerance to autoantigens.
- Trial name
- TOLERANT (NCT05251870)
- Testing
- autologous mature tolerogenic monocyte-derived Dendritic Cells loaded with the B29 peptide of HSP70
- Where
- 3 sites in Netherlands
- Volunteers
- 18 people
- Sponsor
- UMC Utrecht
Down Syndrome, SARS-CoV-2 Vaccination
Prospective Monitoring of Antibody Response Following COVID-19 Vaccination in Patients With Down Syndrome.
The risk of severe course of SARS-CoV-2 infection in people with Down Syndrome is substantially increased. The risk of death is 3-10 fold higher than in healthy people.
- Trial name
- PRIDE (NCT05145348)
- Testing
- Immune response to Sars-CoV-2 vaccinations; including COVID-19 vaccin Moderna, Comirnaty (Pfizer) and Vaxzevria (AstraZeneca)
- Where
- Netherlands
- Volunteers
- 640 people, healthy volunteers welcome
- Sponsor
- UMC Utrecht
Endomyocardial Fibrosis, Pulmonary Valve Stenosis
Right Ventricle Remodeling After Pulmonary Valve Replacement and Percutaneous Pulmonary Valve Insertion
This study investigates damage of the right cardiac chamber in adult patients with a congenital heart defect involving the pulmonary valve (the heart valve between the right cardiac chamber and the lungs).
- Conditions
- Endomyocardial Fibrosis, Pulmonary Valve Stenosis, Pulmonary Valve Insufficiency
- Trial name
- RV-REPAIR (NCT05090228)
- Where
- Netherlands
- Volunteers
- 26 people
- Sponsor
- UMC Utrecht
Infertility
PC Protocol: Preconceptional Screening
Background: Despite considerable progress in the field of assisted reproductive technology (ART) maximum pregnancy rates generally do not exceed 30%.
- Trial name
- PC (NCT02309073)
- Where
- Netherlands
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- UMC Utrecht
Anovulation
The Cycle Disturbances, OLigomenorrhea and Amenorrhea (COLA) Study & Biobank
Through the COLA Study and Biobank the investigators hope to enable further identification of phenotype, endocrine, ethnic, and metabolic characteristics associated with menstrual cycle disturbances; and: the identification of…
- Trial name
- COLA (NCT02309047)
- Where
- Netherlands
- Volunteers
- 5,000 people
- Sponsor
- UMC Utrecht
Cancer, Squamous Cell Carcinoma
Esophagectomy for Patients With Esophageal Cancer and Cervical Lymph Node Metastases
There is no world-wide consensus on the oncological benefit versus increased morbidity associated with three field lymphadenectomy in patients with esophageal cancer and cervical lymph node metastases.
- Conditions
- Cancer, Squamous Cell Carcinoma, Adenocarcinoma, Malignancy
- Trial name
- Node (NCT02426879)
- Testing
- esophagectomy with three-field lymphnode dissection
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- UMC Utrecht
E. Coli Infection
Study to Collect Information About Invasive Disease Caused by Extraintestinal Pathogenic Escherichia Coli-2 (EXPECT-2)
The purpose of this study is to collect information from study participants who are hospitalized with an invasive disease caused by Extraintestinal pathogenic E. coli (ExPEC).
- Trial name
- EXPECT-2 (NCT04117113)
- Where
- 8 sites in United States, Canada and 6 more
- Volunteers
- 238 people
- Sponsor
- UMC Utrecht
Inflammatory Bowel Disease, Colorectal Cancer
Risk Factors for Colorectal Cancer in Patients With Inflammatory Bowel Disease Undergoing Surveillance: a Prospective Cohort Study
Both ulcerative colitis and Crohn's colitis are associated with an increased risk of developing colorectal cancer (CRC). Although the increased risk of CRC in colitis patients is well established, several studies show that the…
- Trial name
- NCT01464151
- Where
- 4 sites in Netherlands
- Volunteers
- 613 people
- Sponsor
- UMC Utrecht
Wheezing
Bronchodilators for Wheeze in Young Children Presenting to Primary Care: a Randomised, Placebo-controlled, Multicentre, Parallel Group Trial
Ten percent of infants are prescribed short-acting bronchodilators (i.e. salbutamol) for wheezing every year, yet evidence to support this treatment in children younger than two years old is scarce.
- Trial name
- KIWI (NCT04584034)
- Testing
- Salbutamol
- Sponsor
- UMC Utrecht
Delirium
DeltaScan Validation Study for the Assessment of Delirium in the ICU and on Wards
Rationale: Delirium is associated with prolonged hospitalization, an increased risk of dementia, institutionalization and mortality, as well as increased costs.
- Trial name
- Val3 (NCT03966274)
- Where
- Netherlands
- Volunteers
- 434 people
- Sponsor
- UMC Utrecht
RSV Infection, Respiratory Syncytial Virus Infections
RESCEU Study: Defining the Burden of Disease of Respiratory Syncytial Virus in Europe in Infants
The REspiratory Syncytial virus Consortium in EUrope (RESCEU) is an Innovative Medicine Initiative (IMI) effort funded by the EU under the H2020 framework to define and understand the burden of disease caused by human respiratory…
- Conditions
- RSV Infection, Respiratory Syncytial Virus Infections, RSV Bronchiolitis
- Trial name
- NCT03627572
- Testing
- No intervention
- Where
- 5 sites in Finland, Netherlands and 2 more
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- UMC Utrecht
Gastric Cancer, Staging
Evaluation of PET and Laparoscopy in STagIng Advanced Gastric Cancer
Objective: To evaluate the impact and cost-effectiveness of FDG-PET/CT (PET) and diagnostic laparoscopy (DLS) in addition to initial staging by CT and gastroscopy in patients with advanced gastric cancer.
- Conditions
- Gastric Cancer, Staging, FDG-PET/CT, Diagnostic Laparoscopy
- Trial name
- PLASTIC (NCT03208621)
- Where
- Netherlands
- Volunteers
- 394 people
- Sponsor
- UMC Utrecht
Diastolic Heart Failure, Hypertension
Denervation of the renAl sympathetIc nerveS in hearT Failure With nOrmal Lv Ejection Fraction
Increasing evidence suggests an important role of activation of the sympathetic nervous system (SNS) in the clinical phenomena of heart failure with normal left ventricular ejection fraction and hypertension.
- Trial name
- DIASTOLE (NCT01583881)
- Testing
- renal denervation
- Where
- 2 sites in Netherlands
- Volunteers
- 60 people
- Sponsor
- UMC Utrecht
Staphylococcus Aureus, Surgical Wound Infection
Advanced Understanding of Staphylococcus Aureus Infections in Europe - Surgical Site Infections
ASPIRE-SSI is a prospective, observational, multicentre cohort study among adult surgical patients, which aims to determine the incidence of healthcare-associated S. aureus infections, particularly S.
- Trial name
- ASPIRE-SSI (NCT02935244)
- Where
- 33 sites in Belgium, Czechia and 8 more
- Volunteers
- 5,004 people
- Sponsor
- UMC Utrecht
Cerebral Hemorrhage, Atrial Fibrillation
Apixaban After Anticoagulation-associated Intracerebral Haemorrhage in Patients With Atrial Fibrillation
There is a marked lack of evidence on the optimal prevention of ischaemic stroke in patients with atrial fibrillation and a recent intracerebral haemorrhage (ICH) during treatment with oral anticoagulation.
- Trial name
- APACHE-AF (NCT02565693)
- Testing
- Apixaban, Aspirin, Carbasalate calcium
- Where
- 16 sites in Netherlands
- Volunteers
- 101 people
- Sponsor
- UMC Utrecht
Breast Cancer
MRI-guided Single Dose Preoperative Radiotherapy in Low-risk Breast Cancer
This study aims to evaluate the pathologic response at 12 months after single dose preoperative partial breast irradiation in early stage breast cancer patients. Furthermore, the aim is to collect data on response monitoring.
- Trial name
- ABLATIVE-2 (NCT03863301)
- Testing
- MR-guided single dose preoperative PBI
- Where
- Netherlands
- Sponsor
- UMC Utrecht
Primary Aldosteronism Due to Aldosterone Producing Adenoma, Primary Aldosteronism
Predicting Reduction of Hypertension After Adrenalectomy for Primary Aldosteronism: a Multicenter Analysis
Primary aldosteronism (PA) is the excessive endogenous production of the mineralocorticoid aldosterone. Although various rare forms of PA exist, the vast majority of cases are accounted by either an aldosterone-producing adenoma…
- Conditions
- Primary Aldosteronism Due to Aldosterone Producing Adenoma, Primary Aldosteronism, Primary Aldosteronism Due to Conn Adenoma
- Trial name
- NCT04761354
- Testing
- Unilateral adrenalectomy
- Where
- 14 sites in United States, Australia and 3 more
- Volunteers
- 514 people
- Sponsor
- UMC Utrecht
Metastatic Breast Cancer, Breast Cancer
Image-guided Targeted Doxorubicin Delivery With Hyperthermia to Optimize Loco-regional Control in Breast Cancer
In this phase I feasibility study, the investigators evaluate the combination of lyso-thermosensitive liposomal doxorubicin (LTLD, ThermoDox) with local hyperthermia and cyclophosphamide (C), for the local treatment of the…
- Conditions
- Metastatic Breast Cancer, Breast Cancer, Breast Neoplasms, Stage IV Breast Cancer
- Trial name
- i-GO (NCT03749850)
- Testing
- LTLD, MR-HIFU induced hyperthermia, Cyclophosphamide
- Where
- Netherlands
- Volunteers
- 12 people
- Sponsor
- UMC Utrecht
Renal Cell Carcinoma
Ablative tReatment of Inoperable REnal Cell Carcinoma Using STereotactic Body Radiotherapy (ARREST-study)
Phase II study (n=30) to evaluate the safety and feasibility of stereotactic body radiation therapy (SBRT) with fiducial markers in inoperable patients with renal cell carcinoma (RCC).
- Trial name
- ARREST (NCT02853162)
- Testing
- ARREST-study
- Where
- Netherlands
- Volunteers
- 30 people
- Sponsor
- UMC Utrecht