Clinical trials: sponsored by Federico II University
Breast Cancer, Breast Cancer Invasive
Metabolic Parameters and Quality of Life in Women on Neo-/Adjuvant Therapy for Breast Cancer
The present trial aims to compare the effectiveness of an "intensive" vs a "standard" nutritional intervention on body weight regulation and some metabolic parameters in women on adjuvant/neoadjuvant therapy for breast cancer.
- Trial name
- NCT07044791
- Testing
- Nutritional counseling. No drug treatment will be administered in this study.
- Where
- Italy
- Volunteers
- 120 people
- Sponsor
- Federico II University
Lupus Nephritis (LN), ANCA Associated Vasculitis (AAV)
SGLT-2 Inhibitors on Albuminuria in Chronic Kidney Disease Patients With Lupus Nephritis and ANCA- Associated Vasculitis
The goal of this clinical trial is to investigate the effect of the glifozines on albuminuria in chronic kidney disease patients affected by lupus nephritis and ANCA associated renal vasculitis.
- Trial name
- NCT07035834
- Testing
- Gliflozin
- Volunteers
- 40 people
- Sponsor
- Federico II University
Cancer
The ICT Based Prescription of Physical Activity for Oncology Patients at Their Home
Study evaluating the efficacy of ICT-based prescription of physical activity in oncology patients
- Trial name
- EASYDOM (NCT07021196)
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Federico II University
the Presence of Subretinal Fluid (SRF)
Green Subthreshold Laser Therapy for Chronic Central Serous Chorioretinopathy.
Chronic Central Serous Chorioretinopathy (CSCR) is a vision-threatening retinal disorder characterized by persistent subretinal fluid due to choroidal vascular hyperpermeability and retinal pigment epithelium (RPE) dysfunction.
- Trial name
- NCT07020793
- Testing
- green subthreshold laser therapy
- Where
- Italy
- Volunteers
- 12 people
- Sponsor
- Federico II University
Glycemic and Insulinemic Response, Type 1 Diabetes (T1D)
Glycemic Response to Carbob-Enriched Pasta in Healthy and With Type 1 Diabetes People
Carob (Ceratonia siliqua) is a fruit traditionally used in various Mediterranean countries for the preparation of sweets and beverages.
- Trial name
- GR-CEP (NCT06994403)
- Testing
- Durum wheat pasta enriched with carob flour, Standard durum wheat pasta, White bread reference meal
- Where
- Italy
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Federico II University
Food Allergy in Children
The Naples Pediatric Food Allergy (NAPFA) Score
Food Allergy (FA) is one of the most expensive allergic disorders in the pediatric age, and affecting up to 10% of children worldwide, it is recognized as a global health problem.
- Trial name
- NAPFA (NCT05707858)
- Testing
- Development of the NAPFA score
- Where
- Italy
- Volunteers
- 600 people
- Sponsor
- Federico II University
Femur Fracture, Peripheral Nerve Block
Peripheral Nerve Blocks vs Selective Spinal Anesthesia in Patients With Femur Fracture
Proximal Femur Fractures (PFF) represent one of the most common orthopedic injuries worldwide, affecting especially elderly patients with potentially disabling outcomes and a marked impairment of quality of life.
- Conditions
- Femur Fracture, Peripheral Nerve Block, Spinal Anesthesia
- Trial name
- NCT06155903
- Testing
- Selective Spinal Anesthesia, Peripheral nerve blocks, Anesthesiological mixtures (Spinal anesthesia)
- Where
- Italy
- Volunteers
- 78 people
- Sponsor
- Federico II University
Allergy
Virtual Reality During Skin Prick Test
Skin prick testing (SPT) is a cornerstone diagnostic procedure for identifying allergic sensitizations in pediatric patients. Despite being minimally invasive, it often provokes considerable anxiety, fear, and pain, potentially…
- Trial name
- NCT06952192
- Testing
- Virtual reality
- Where
- Italy
- Volunteers
- 108 people
- Sponsor
- Federico II University
Aortoiliac Aneurysm, Iliac Aneurysm
CAMpania PugliA bRanch Iliaco
Spontaneus Multicentric Observational registry to investigate the medium and long-term performances of the Iliac E-liac Branch Device from Artivion for treatment of Aortoiliac aneurysms in a real-world consecutive patients cohort.
- Trial name
- CAMPARI (NCT06946381)
- Testing
- Evar
- Where
- 2 sites in Italy
- Volunteers
- 200 people
- Sponsor
- Federico II University
Stage 3 AMD
Lutein by Scleral Iontophoresis in AMD
The objective of the clinical investigation is to evaluate the performance, safety and degree of tolerability resulting from the use of the iontophoresis medical device in adult subjects diagnosed with AMD stage 3 (AREDS…
- Trial name
- NCT06925893
- Where
- Italy
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Federico II University
Diabetes Mellitus Type 2
Medium-term Effects of a Polyphenol-rich Beverage Based on Red Grape Pomace Extract on Non-alcoholic Fatty Liver Disease, Cardiometabolic Risk Profile and Gut Microbiota in Subjects with Type 2 Diabetes
Nonalcoholic fatty liver disease (NAFLD) is a liver disease characterized by an abnormal accumulation of fat not due to alcohol or drug consumption that can evolve into steatohepatitis (NASH), fibrosis and cirrhosis.
- Trial name
- PoLiFat (NCT06895018)
- Testing
- Supplementation with Polyphenol Rich Drink
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- Federico II University
Ischemia, Myocardial, Non-Obstructive Coronary Atherosclerosis
INOCA-NA a Local Prospective Registry
The present study has the following objectives: 1. To investigate the prevalence of INOCA in patients referring for a clinically indicated coronary angiography (CA) c/o Division of Cardiology - Federico II University Hospital; 2.
- Conditions
- Ischemia, Myocardial, Non-Obstructive Coronary Atherosclerosis, Microcirculatory Status, Coronary Microvascular Dysfunction (CMD)
- Trial name
- INOCA-NA (NCT06588244)
- Where
- Italy
- Volunteers
- 250 people
- Sponsor
- Federico II University
Coronary Artery Disease
Effects of Cangrelor on MIcRovAscular Disfunction During Elective Percutaneous CORonary Intervention
Dual Antiplatelet Therapy represents the main therapy for patients presenting with chronic coronary syndromes and undergoing elective PCI.
- Trial name
- MIRACOR (NCT06089577)
- Testing
- Cangrelor 50 MG
- Where
- 2 sites in Italy
- Volunteers
- 80 people
- Sponsor
- Federico II University
Congenital Hypothyroidism
Quality of Life and Long-term Outcome of Adequately Treated Congenital Hypothyroidism
The primary objective of this observational study is the evaluation of the quality of life and long-term outccome of young-adult patients with congenital hypothyroidism diagnosed by neonatal screening receiving replacement…
- Trial name
- CHQoL (NCT06864039)
- Testing
- SF36 test, WAIS IV test, SCL-90 psychopathological screening questionnaire
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Federico II University
Classic Hodgkin Lymphoma, Advanced Hodgkin Lymphoma
Brentuximab Vedotin with Adriamycin, Vinblastine and Dacarbazine for Patients Aged 18-59 Years with Untreated Advanced-stage Classical Hodgkin Lymphoma: a Real-life Experience
Classical Hodgkin lymphoma (cHL) is commonly diagnosed in young adults and adults (YP\&A) defined by the National Cancer Institute as 18 to 59 years of age.
- Trial name
- FED_RealBV (NCT06857500)
- Where
- Italy
- Volunteers
- 200 people
- Sponsor
- Federico II University
Acute Cardiovascular Disease, Acute Coronary Syndrome
Naples Federico II Intensive Cardiac Care Unit Registry (Naples FED2-ICCU Registry)
This protocol proposes to prospectively evaluate current epidemiology, pharmacologic and invasive management and clinical outcomes of patients with acute cardiovascular diseases admitted at our ICCU.
- Conditions
- Acute Cardiovascular Disease, Acute Coronary Syndrome, Acute Heart Failure, Cardiogenic Shock
- Trial name
- NCT06162247
- Where
- Italy
- Volunteers
- 5,000 people
- Sponsor
- Federico II University
Migration of Implant or Internal Device
Ultrasound to Investigate Tip Dislodgment of Epicutaneous-caval Catheter.
This is a non-pharmacological, non-profit, prospective, observational multicenter study. Primarily, the study aims to demonstrate the feasibility of ultrasound methodology to study the secondary malposition of epicutaneous-caval…
- Trial name
- DISLOTIP (NCT06438289)
- Where
- Italy
- Volunteers
- 217 people, healthy volunteers welcome
- Sponsor
- Federico II University
Rhinitis Viral
The ELYAR (Elysium Against Rhinitis) Project
Acute rhinitis is an inflammatory process that primarily affects the nasal mucosa, with a high incidence in the pediatric population and a morbidity rate of 6-8 episodes annually during the first two years of schooling (1).
- Trial name
- ELYAR (NCT06757179)
- Testing
- Elysium Naso Gola
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Federico II University
Prostate Inflammation, Prostate Disease
The Role of Butirprost® in Combination With Antibiotics in Chronic Bacterial Prostatitis (CBP) Treatment
Bacterial prostatitis (BP) is a common prostatic infection characterized by pain and urinary symptoms, often with negative bacterial cultures from prostatic secretions.
- Conditions
- Prostate Inflammation, Prostate Disease, Chronic Bacterial Prostatitis
- Trial name
- NCT06684626
- Testing
- Sodium Hyaluronate, Levofloxacin 500mg
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Federico II University
Diabetes, Pre-diabetes
Effect of Oral L-arginine 3.32 g a Day on Oxidative Stress Influencing Beta Cell Function and Insulin Resistance.
The objective of this clinical trial is to explore whether L-arginine supplementation with 3.32g/day may enhance antioxidant defenses in overweight and obese patients with pre-diabetes and metabolic syndrome, possibly providing…
- Conditions
- Diabetes, Pre-diabetes, Metabolic Syndrome
- Trial name
- L-BIOARG (NCT06686069)
- Testing
- bioarginina zero
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Federico II University