Clinical trials: sponsored by Federico II University
Sacroiliitis, Low Back Pain
Neurolyser XR for the Treatment of Sacroiliitis
Our study aims to investigate the safety and efficacy of high intensity focused ultrasound in the management of low back pain due to sacroiliitis.
- Trial name
- NCT07647757
- Testing
- Patients treated with high intensity focused ultrasound
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Federico II University
Glycogen Storage Disease Type I
Use of Continuous Glucose Monitoring to Evaluate Postprandial Response to Raw Cornstarch Supplementation in Adult Glycogen Storage Disease Type I
The aim of this observational study is to evaluate the impact of raw cornstarch supplementation on postprandial glycemic response in adult patients with Glycogen Storage Disease type I (GSD I), using continuous glucose monitoring…
- Trial name
- NCT07645898
- Where
- Italy
- Volunteers
- 8 people
- Sponsor
- Federico II University
Squamous Cell Carcinoma of Oropharynx
Patients With Human Papillomavirus-associated Head and Neck Cancer for the Discovery of Predictive Biomarkers to Guide Clinical Intervention
Prospective pilot study, non-interventional, of a biological/radiological nature, which involves the collection of tissue samples, and blood from patients suffering from squamous cell carcinoma of the oropharynx OPSCC for…
- Trial name
- NCT06821243
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- Regina Elena Cancer Institute
Hypoxic-Ischemic Encephalopathy, Asphyxia Perinatal
Identification of a Pool of miRNA to Improve Early Management of Perinatal Asphyxia and Hypoxic Ischemic Encephalopathy
Hypoxic-ischemic encephalopathy is the most common cause of neurological damage in the neonatal period. It has an incidence of about 1.5-2.5% of livebirths in developed countries.
- Trial name
- NCT05986994
- Testing
- Metabolic acidosis, microRNA, Hypothermia
- Where
- 2 sites in Italy
- Volunteers
- 45 people
- Sponsor
- Ospedale Buon Consiglio Fatebenefratelli
Intracerebral Hemorrhage, Brain Hematoma
Microplastics in Brain Hematomas and Neurological Outcomes After Intracerebral Hemorrhage
This observational study investigates the presence of micro- and nanoplastics in surgically removed intracerebral hematomas and their association with neurological outcomes in patients with spontaneous intracerebral hemorrhage.
- Trial name
- PARTENOPE (NCT07580326)
- Testing
- Observational Analysis
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- University of Campania Luigi Vanvitelli
Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Crohn Disease (CD)
Eating Disorders in Patients With IBD
Inflammatory bowel diseases (IBD) may influence eating habits and lead some patients to adopt restrictive dietary behaviours to control gastrointestinal symptoms.
- Conditions
- Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Crohn Disease (CD), Ulcerative Colitis (UC), ARFID
- Trial name
- NCT07610694
- Where
- Italy
- Volunteers
- 355 people
- Sponsor
- Federico II University
Heart Failure
Validation of the Italian SCHFI v.8 and the CC-SCHFI v.3
This observational study aims at validating the Italian Self-care of Heart Failure Index (SCHFI) v.8 and the Caregiver Contribution to Self-care of Heart Failure Index (CC-SCHFI) v.3
- Trial name
- NCT07608393
- Testing
- Administration of the Italian version of the SCHFI and the CC-SCHFI, plus other self-reported ouctome measures
- Volunteers
- 1,000 people
- Sponsor
- Centro Cardiologico Monzino
Breast Cancer, HER2 Negative Breast Cancer
Shared Decision Making for Patients With HER2-negative Metastatic Breast Cancer (SDM-01)
Background and Purpose: Deciding on the best treatment for HER2-negative metastatic breast cancer (MBC) is a complex process. Patients often have unique values and preferences regarding their care and quality of life.
- Conditions
- Breast Cancer, HER2 Negative Breast Cancer, Metastatic Breast Cancer
- Trial name
- SDM-01 (NCT07578415)
- Testing
- Shared Decision Making (SDM) Support Program
- Volunteers
- 120 people
- Sponsor
- Federico II University
Sebum Production, Acne Scars
SMosE Safety and Efficacy Evaluation as a Skin Adaptogen
This study evaluates the biological activity, safety, and clinical efficacy of SMosE (Shiitake Mushroom Oil-Soluble Extract), a topical cosmetic ingredient developed to support skin barrier function, adaptogenic responses, and…
- Conditions
- Sebum Production, Acne Scars, Skin Barrier to Water Loss
- Trial name
- SMosE (NCT06338046)
- Testing
- Corthellus Shiitake(Mushroom) Extract
- Where
- Italy
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Federico II University
Delphi Process, Delphi Study
TRacheostomy in DElphi for iNTensive Care' (TRiDENT)
The aim of this study is to develop international consensus-based recommendations for tracheostomy care in critically ill patients.
- Trial name
- TRiDENT (NCT07481435)
- Testing
- Delphi Consensus Process
- Volunteers
- 40 people
- Sponsor
- Universita degli Studi di Genova
Autoimmune Hyperthyroidism, Children
Autoimmune Hyperthyroidism in Prepubertal Children
The investigators propose a multicenter retrospective study to assess clinical, biochemical, and auxological characteristics at diagnosis and during follow-up in a cohort of Caucasian pediatric patients diagnosed with autoimmune…
- Trial name
- IPER6 (NCT07544290)
- Testing
- restrospective observational study
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- IRCCS Ospedale San Raffaele
Cow Milk Allergy
Epigenetic Effects in Children With Cow's Milk Allergy Treated With Different Formulas
Lactobacillus GG (LGG) is able to exert long lasting effects in children with atopic disorders. Nutramigen LGG accelerates tolerance acquisition in infants with cow's milk allergy.
- Trial name
- EPICMA II (NCT04184700)
- Testing
- EHCF+LGG, RHF, SF
- Where
- Italy
- Volunteers
- 90 people
- Sponsor
- Federico II University
Diabetic Retinopathy, DR
Epivascular Glia Regression and Macular Pigment Restoration After Faricimab in Diabetic Retinopathy
The aim of the study is to evaluate in diabetic patients affected by diabetic retinopathy epivascular glia regression and macular pigment restoration after faricimab injection in diabetic retinopathy in a 1 year follow up
- Trial name
- GLIA-MAC (NCT07526857)
- Testing
- Faricimab Injection [Vabysmo], Aflibercept (2.0 mg)
- Where
- Italy
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Federico II University
Atopic Dermatitis
Therapeutic Efficacy of Cutaneous Application of Postbiotic N-(1-carbamoyl-2-phenyl-ethyl) Butyramide (FBA) in Pediatric Subjects Affected by Atopic Dermatitis
Atopic dermatitis (AD) is a chronic, multifactorial inflammatory skin disease characterized by eczematous skin and pruritus and it's due to an alteration of the skin barrier and of the intestinal and skin microbiome (SM), which…
- Trial name
- BuPAD (NCT07016087)
- Testing
- Cosmetic formulation experimental, Cosmetic formulation usual
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Federico II University
Acute Coronary Syndrome, Gender
Prospective Multicenter Registry of Gender, Diversity and Inclusion (GEDI) of Women With Acute Coronary Syndrome
Create a multicenter prospective registry that collects information from women affected by acute coronary syndrome (ACS). This registry aims to understand the diversity in the presentation of women with ACS.
- Conditions
- Acute Coronary Syndrome, Gender, Genetic Predisposition
- Trial name
- ACS GEDI (NCT06441942)
- Where
- 4 sites in Italy
- Volunteers
- 100 people
- Sponsor
- IRCCS San Raffaele
Oncologic Disease, Urgent Surgery
Dynamic Postoperative Trends for Early Detection of Complications After Gastrointestinal Surgery
Postoperative complications after gastrointestinal (GI) surgery remain a major source of morbidity, mortality, prolonged hospitalisation, and healthcare costs.
- Trial name
- DYNAMIC-GI (NCT07509710)
- Testing
- blood sampling
- Volunteers
- 1,500 people
- Sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
NASH With Fibrosis, Diabete Type 2
Non-invasive Tests for Non-alcoholic Steato-hepatitis
The main objective is to study and validate a new approach for NASH and liver fibrosis diagnosis and personalized follow-up based on monocyte biomarkers and plasma metabolites.
- Conditions
- NASH With Fibrosis, Diabete Type 2, Obesity
- Trial name
- TEIRESEAS (NCT07502755)
- Testing
- Administration of Deuterated water
- Where
- Italy
- Volunteers
- 828 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Type 2 Diabetes
Characterization of Cardiovascular Risk Profile and Therapeutic Management in Patients With Type 2 Diabetes Mellitus in Italy
CardioMET is an observational, multicenter, real-life registry, intending to collect data on patients with Type 2 Diabetes Mellitus, attending internal medicine and cardiology outpatient clinics.
- Trial name
- CardioMET (NCT07375069)
- Testing
- data collection
- Where
- Italy
- Volunteers
- 3,000 people
- Sponsor
- Federico II University
Multiple Sclerosis
Using Motor Imagery-based Brain-computer Interface With Multiple Sclerosis Patients.
The goal of this clinical trial is to evaluate the effectiveness of a wearable brain-computer interface (BCI)-based neurofeedback system using motor imagery (MI) to support upper limb motor rehabilitation in patients with…
- Trial name
- BCI_MI_SM_2026 (NCT07472556)
- Testing
- Brain Computer Interface
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- Pasquale Arpaia
STEMI (ST Elevation MI)
Inhibition of Late Sodium Current (INa) to Prevent Coronary MICROvascular Dysfunction in Patients Presenting With ST-Elevation Myocardial Infarction and Multivessel Disease: INaMICRON Study
This is a Phase IIb, multicentric, prospective, randomized (1:1 ratio), open label, and no profit study, with the aim of evaluating the efficacy of late INa current inhibition to improve coronary microcirculation in patients…
- Trial name
- INaMICRON (NCT07380919)
- Testing
- Ranolazine
- Where
- 3 sites in Italy
- Volunteers
- 100 people
- Sponsor
- Federico II University