Clinical trials: sponsored by Federico II University
Atopic Dermatitis
The Potential Role of Compounds Derived From Ultra-processed Foods in the Pathogenesis of Atopic Dermatitis in Pediatric Age
Atopic dermatitis (AD) is a common chronic inflammatory skin condition, primarily affecting children in urban and high-income areas.
- Trial name
- UPAD Project (NCT06996327)
- Testing
- Evaluation of dietary consumption of UPFs
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Federico II University
Esophagitis, Eosinophilic
The Potential Role of Compounds Derived From Ultra-processed Foods in Pathogenesis of Eosinophilic Esophagitis
Eosinophilic esophagitis (EoE) is a chronic antigen-mediated inflammatory disease of the esophagus that affects both children and adults.
- Trial name
- NCT06093204
- Testing
- Dietary evaluation
- Where
- 2 sites in Italy
- Volunteers
- 100 people
- Sponsor
- Federico II University
Autism Spectrum Disorder
Probiotics for Autism Spectrum Disorders: a Randomized Controlled Trial (The PASD Study)
Autism spectrum disorders (ASD) are a group of severe neurodevelopmental conditions characterized by impaired communication and social interaction, as well as repetitive/stereotyped behaviors deriving from a combination of…
- Trial name
- PASD (NCT07345585)
- Testing
- Lactobacillus rhamnosus GG
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Federico II University
Breast Cancer, Triple Negative Breast Cancer (TNBC)
Circulating Tumor DNA Dynamics to Optimize Neoadjuvant Therapy in HER2-Positive and Triple-Negative Breast Cancer
The purpose of this non-interventional, observational study is to evaluate the clinical utility of circulating tumor DNA (ctDNA) utility-specifically how quickly tumor DNA disappears from the bloodstream (ctDNA clearance)-to help…
- Conditions
- Breast Cancer, Triple Negative Breast Cancer (TNBC), HER2 + Breast Cancer
- Trial name
- NEOSHED (NCT07662252)
- Volunteers
- 186 people
- Sponsor
- Federico II University
Overweight and Obesity
Dietary Intervention With Probiotic Pasta and Evaluation of the Effects on Metabolic and Inflammatory Status
This study aims to investigate the effects of daily consumption for 4 weeks of a probiotic durum wheat pasta vs a conventional durum wheat pasta without probiotics on fasting metabolic parameters and inflammatory status, on gut…
- Trial name
- ProPas (NCT04962633)
- Testing
- Probiotic Pasta, Control Pasta
- Where
- Italy
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- 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
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
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
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
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
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
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
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
Fall Risk, Fall Prevention, Fall Risk
Fall Prevention in Older Adults in an Italian Cohort
Proximal femoral fractures are associated with increased mortality in older adults and may contribute to loss of functional independence, resulting in a higher risk of long-term institutionalization.
- Conditions
- Fall Risk, Fall Prevention, Fall Risk, Accidental Falls
- Trial name
- NCT07437690
- Testing
- Khymeia
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Federico II University
Asthma Acute, Allergic Rhinitis
Immune Nutrition in Pediatric Respiratory Allergy
Respiratory allergic diseases, namely asthma and allergic rhinitis (AR), are among the most common chronic pediatric conditions with prevalence continuing to rise over last decades and are leading healthcare costs.
- Trial name
- INAPRA (NCT07308288)
- Testing
- AllergySTOP
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- Federico II University
Hypercholesterolaemia
Evaluation of Adherence, Persistence and Efficacy of Treatment With Alirocumab 300mg in Italy
Evaluation of adherence, persistence and efficacy of treatment with alirocumab 300 mg in a real-life Italian population.
- Trial name
- ALINET (NCT07375225)
- Testing
- Praluent (Alirocumab)
- Where
- Italy
- Volunteers
- 1,500 people
- Sponsor
- Federico II University
Hypercholesterolemia
Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Bempedoic Acid in Italy
Evaluation of adherence, persistence, and efficacy of treatment with Bempedoic acid in a real-life Italian population.
- Trial name
- BEMPENET (NCT07374861)
- Testing
- Bempedoic acid
- Where
- Italy
- Volunteers
- 1,500 people
- Sponsor
- Federico II University
Hypercholesterolemia
Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy
Evaluation of adherence, persistence and efficacy of treatment with PCSK9 inhibitors in a real-life Italian population.
- Trial name
- AT-TARGET-IT (NCT05430828)
- Testing
- Repatha (evolocumab); Praluent (alirocumab)
- Where
- 27 sites in Italy
- Volunteers
- 5,000 people
- Sponsor
- Federico II University