Clinical trials: sponsored by Mario Negri Institute for Pharmacological Research
Glomerulopathy, C3G
Pilot STUDY to Monitor Ex-vivo the Biological Effects of the C3 Inhibitor, PEGCETACOPLAN, on Activation of Complement in Fluid Phase and on Podocytes in Patients With C3G and Primary IC-MPGN
This is a prospective, multicenter, non-interventional, observational pharmacological real-world study to characterize longitudinal changes in ex vivo biomarkers of complement activation in patients with C3G and primary IC-MPGN…
- Conditions
- Glomerulopathy, C3G, Membranoproliferative Glomerulonephritis (MPGN)
- Trial name
- COMPASS (NCT07904338)
- Testing
- Blood sample
- Where
- Italy
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Mario Negri Institute for Pharmacological Research
Breast Cancer, Interstitial Lung Disease (ILD)
Premedication With Dexamethasone for Preventing Interstitial Lung Disease in Patients With Breast Cancer Treated With Trastuzumab Deruxtecan
Trastuzumab deruxtecan (T-DXd) has recently received approval as an antibody-drug conjugate for treating patients with metastatic breast cancer (BC) who have HER-2 protein expression as determined by immunohistochemistry…
- Trial name
- MARGARET (NCT07828054)
- Testing
- Dexamethasone, antiemetic premedication, T-DXd
- Volunteers
- 244 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Brain Injuries, Acute
Severe Acquired Brain Injuries: Prognostic Factors and Quality of Care
The main purpose of this project is to identify the medium-term prognostic factors for patients with Severe Acquired Brain Injuries and evaluate their impact.
- Trial name
- NCT04905264
- Where
- 27 sites in Italy
- Volunteers
- 2,500 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Cardiovascular (CV) Risk, Inflammation
RESOLving INflammation Through Diet for Health (RESOLVIN)
Hyperlipidemia is the main driver of atherosclerotic cardiovascular disease (ASCVD), both through direct effects and as trigger of the chronic inflammation behind a cardiovascular health-to-disease transition.
- Conditions
- Cardiovascular (CV) Risk, Inflammation, Omega 3
- Trial name
- RESOLving (NCT07331103)
- Testing
- Fish Oil, Camelina oil, Vitamin E
- Where
- 9 sites in Italy
- Volunteers
- 324 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Emergency Medicine
Propensity to Hospitalize Patients From the ED in European Centers.
The peer-to-peer comparison means center-to-center comparison, which requires adjusting for possible differences among centers to be fair and convincing.
- Trial name
- eCREAM-UC1 (NCT06354764)
- Testing
- no intervention
- Where
- 2 sites in Italy
- Volunteers
- 162,000 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Emergency Medicine
Development of a Multipurpose Dashboard to Monitor the Situation of Emergency Departments
An emergency department (ED) is a healthcare service that provides the first clinical assessment and treatment to patients with various acute conditions.
- Trial name
- eCREAM-UC2 (NCT06372379)
- Testing
- no intervention
- Where
- 2 sites in Italy
- Volunteers
- 162,000 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Emergency Departments
Emergency and Urgent Care Indicators in Piedmont
The Emergency Department represents the main entry point to the hospital and a key setting for the management of urgent healthcare needs in the population.
- Trial name
- PRIME (NCT07606209)
- Where
- Italy
- Volunteers
- 650,000 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Emergency Departments
Mild TBI in the Emergency Department
Mild TBI is one of the main causes of admission to the Emergency Department (ED). Brain computed tomography (CT) is one of the most widely used diagnostic tools to assess the presence of intracranial lesions.
- Trial name
- NCT07021118
- Where
- 59 sites in Italy, Switzerland
- Volunteers
- 2,500 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Amyotrophic Lateral Sclerosis
Trial on the Biological and Clinical Effects of Acetyl-L-carnitine in ALS
Phase II/III multicenter, randomized, double-blind, placebo-controlled trial on acetyl-L-carnitine (ALCAR) in subjects living with amyotrophic lateral sclerosis (ALS).
- Trial name
- ALCALS (NCT06126315)
- Testing
- Acetyl-l-carnitine
- Where
- 19 sites in Australia, Italy
- Volunteers
- 246 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Membranous Nephropathy
Obinutuzumab in Primary MN
Primary membranous nephropathy (MN) is an antibody-mediated autoimmune glomerular disease, that represents one of the most frequent causes of nephrotic syndrome in adults.
- Trial name
- ORION (NCT05050214)
- Testing
- Obinutuzumab
- Where
- 2 sites in Italy
- Volunteers
- 20 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Ovarian Cancer
Implementation of New Models of Ovarian Carcinoma Resistant to Therapy
The project focuses on developing new experimental models of ovarian cancer that accurately reflect patients who do not respond to first-line platinum-based treatments and who are resistant to PARP inhibitors (PARPi).
- Trial name
- NCT07757711
- Testing
- Platinum drugs and PARPi
- Volunteers
- 50 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Emergency Medicine
Development of a Natural Language Processing Tool to Enable Clinical Research in Emergency Medicine
The goal of this retrospective cohort study is to develop and validate a language model that can interpret the contents of emergency department electronic medical records and extract relevant information for research purposes in…
- Trial name
- NLP-DeVal (NCT06240572)
- Testing
- no intervention
- Where
- 8 sites in Italy
- Volunteers
- 300,000 people, healthy volunteers welcome
- Sponsor
- Mario Negri Institute for Pharmacological Research
Membranous Nephropathy
MOR202 for Refractory MN
Membranous nephropathy (MN) - the leading cause of nephrotic syndrome (NS) in adults - is an immune-mediated disease that results from the deposition of immunoglobulins and complement components onto the sub-epithelial layer of…
- Trial name
- MONET (NCT04893096)
- Testing
- MOR202
- Where
- 2 sites in Italy
- Volunteers
- 10 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Traumatic Brain Injury
Trauma Molecular Processes
The TRAUMAP study will function as a brain tissue repository for biopsy specimens from patients with traumatic brain injury undergoing brain surgery for contusion removal.
- Trial name
- TRAUMAP (NCT07683169)
- Where
- 2 sites in Italy
- Volunteers
- 500 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Carcinoma, Ovarian Epithelial
First Line Treatment With Olaparib in Combination With Bevacizumab in HRD Positive Patients
The goal of this prospective, phase IV, multi-centre clinical trial is to to define the proportion of patients with advanced high grade epithelial ovarian cancer (EOC) HRD-positive who will be treated at first line with olaparib…
- Trial name
- IOLANTHE (NCT06121401)
- Testing
- Olaparib, Bevacizumab
- Where
- 14 sites in Italy
- Volunteers
- 190 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Chronic Kidney Disease (Stages 4 and 5)
Thyroid Hormones in CKD
This is a retrospective, observational, study evaluating circulating thyroid hormone profiles in patients with severe chronic kidney disease (CKD stages G4-G5, non-dialysis).
- Trial name
- THYROID-CKD (NCT07663773)
- Testing
- Laboratory measurements
- Where
- Italy
- Volunteers
- 51 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Emergency Department, Crowding
A New Crowding Indicator in the Emergency Department
Fenice has proposed a new indicator to measure the level of crowding in the ER. The aim of this study is to evaluate, in a national multicenter context, the degree of agreement between the Fenice indicator and the perception of…
- Trial name
- NCT07111624
- Where
- 52 sites in Italy
- Volunteers
- 828 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Quality of Care, Evaluation
Evaluation of the Quality of Care in the Emergency Department by Studying the Appropriateness of Admissions of Patients Accessing the Emergency Department (Fondazione IRCCS Ca' Granda Ospedale Maggione Policlinico)
The aim of this study is to develop, study and validate a rigorous and sustainable method for assessing the clinical appropriateness of the decision taken in the Emergency Department to admit or not to admit patients.
- Conditions
- Quality of Care, Evaluation, Emergency Department, Appropriateness
- Trial name
- NCT06345352
- Where
- Italy
- Volunteers
- 1,200 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Semi-intensive Care Unit, Evaluation
Health-care Quality in Semi-intensive Care Units
The main aim of this study is to realize a system of continuous evaluation of healthcare quality in semi-intensive care units.
- Conditions
- Semi-intensive Care Unit, Evaluation, Quality
- Trial name
- NCT04676347
- Where
- 18 sites in Italy
- Volunteers
- 39,000 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Aging, Inflammation
Mitigating Mitochondrial RNA Release During Aging to Control Inflammation and Senescence
The MIRACLE study aims to investigate age-related mitochondrial dysfunction, mitochondrial RNA (mtRNA) release, inflammation, and cellular senescence in adult participants across three age groups.
- Conditions
- Aging, Inflammation, Healthy Ageing
- Trial name
- MIRACLE (NCT07596615)
- Testing
- Skin biopsy and venous blood sampling
- Where
- 2 sites in Italy
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Mario Negri Institute for Pharmacological Research