Clinical trials: sponsored by Federico II University
Hypercholesterolemia
Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy
Evaluation of adherence, persistence and efficacy of treatment with Inclisiran in a real-life Italian population
- Trial name
- CHOLINET (NCT06287177)
- Testing
- Inclisiran
- Where
- Italy
- Volunteers
- 3,000 people
- Sponsor
- Federico II University
T2DM (Type 2 Diabetes Mellitus)
GLP1-RAs Effects on Inflammatory and Endothelial Biomarkers in T2DM
Type II diabetes mellitus (T2DM) is a chronic disease associated with a very high risk of developing cardiovascular (CV) events, especially because of its long-term effects.
- Trial name
- STABLE-GLP1 (NCT07314684)
- Testing
- semaglutide, Standard Treatment (Guideline-Based)
- Where
- 2 sites in Italy
- Volunteers
- 80 people
- Sponsor
- Federico II University
Peri-implant Mucositis, Mucositis Oral
Treatment of Peri-implant Mucositis by Sodium Hypochlorite Gel and Cross-linked Hyaluronic Acid Gel
The aim of the study is to evaluate the potential of the combination of a sodium hypochlorite-based gel and a hyaluronic acid-based gel as an adjuvant to Non-Surgical Mechanical Debridement (NSMD) in the treatment of mucositis…
- Trial name
- NCT05926297
- Testing
- Application NaOCl gel + HA gel, Non-surgical mechanical debridement
- Where
- 2 sites in Hungary, Italy
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Federico II University
Food Allergies
Nutritional Status in Children With Food Allergy: Evaluation of a New Supplement
Allergic diseases are rising globally. By 2025, over half of the European population is projected to be affected by some form of allergy, with the highest rates among infants and young children.
- Trial name
- ALLERGYSTOP (NCT06751810)
- Testing
- Food supplement
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Federico II University
Polycytemia Vera
Evaluation of Real-World Data on Ropeginterferon Alfa-2b in Patients With Polycythemia Vera: Insights From a Multicenter Study
This retrospective study aims to evaluate the effectiveness and safety of Ropeginterferon Alfa-2b (BESREMI) in patients with Polycythemia Vera (PV).
- Trial name
- MIRROR (NCT07282132)
- Testing
- Ropeginterferon alfa-2b (BESREMi®)
- Volunteers
- 150 people
- Sponsor
- Federico II University
Myoma;Uterus, Adhesion; Uterus, Internal
Incidence of Intrauterine Adhesions After Myomectomy With Intrauterine Anti-Adhesion Gel
This prospective randomized study aims to evaluate whether the application of an intrauterine anti-adhesion gel reduces the incidence of intrauterine adhesions (IUAs) following robotic-assisted laparoscopic myomectomy.
- Trial name
- NCT07280286
- Testing
- Women will receive the application of an anti-adhesion gel at the end of the myomectomy procedure
- Volunteers
- 62 people
- Sponsor
- Federico II University
Obesity, Type 2 Diabetes
Effects of Oral Sodium Butyrate Supplementation on Body Weight Reduction in Overweight/Obese Individuals With and Without Type 2 Diabetes
The goal of this clinical trial (randomized controlled trial with parallel group design) is to evaluate the effects of oral sodium butyrate supplementation for 12 weeks, compared with placebo, in addition to a moderately…
- Trial name
- ButRed (NCT07252609)
- Testing
- Sodium Butyrate (NaBut)
- Where
- Italy
- Volunteers
- 46 people
- Sponsor
- Federico II University
Rhinitis, Allergic
The ARHINASD (Allergic Rhinitis in Pediatric Subjects With Nasal Septum Deviation) Project
Allergic rhinitis is one of the most common inflammatory conditions of the upper airway mucosa, especially in the pediatric population with a prevalence of approximately 25%.
- Trial name
- NCT06139185
- Testing
- Data collection
- Where
- 2 sites in Italy
- Volunteers
- 69 people
- Sponsor
- Federico II University
Achalasia, Esophageal, Achalasia
The Use of Indocyanine Green Fluorescence (ICG) During Laparoscopic Heller- Dor
The aim this prospective observational study is to evaluate the role of Indocyanine Green Fluorescence (ICG) in patients with achalasia underwent to Heller-Dor laparoscopic.
- Conditions
- Achalasia, Esophageal, Achalasia, Indocyanine Green (ICG), Indocyanine Green
- Trial name
- NCT07181070
- Where
- Italy
- Volunteers
- 70 people
- Sponsor
- Federico II University
Type 1 Diabetes
Evaluation of Main Determinants of Postprandial Glucose Response in Type 1 Diabetes
The goal of this observational study is to explore inter- and intra-individual determinants of postprandial glucose response in patients with type 1 diabetes using continous glucose monitoring (CGM).
- Trial name
- IN-DEEP (NCT05936242)
- Where
- Italy
- Volunteers
- 200 people
- Sponsor
- Federico II University
Congenital Adrenal Hyperplasia
Congenital Adrenal Hyperplasia Once Daily Hydrocortisone Treatment
This is a controlled, open study designed to compare the effects of dual-release hydrocortisone preparations versus conventional glucocorticoid therapy on clinical, anthropometric parameters, metabolic syndrome, hormonal profile…
- Trial name
- CareOnTIME (NCT03760835)
- Testing
- Conventional Glucocorticoids (immediate release hydrocortisone, cortisone acetate, prednisone, prednisolone, dexamethasone), Dual release hydrocortisone (plenadren)
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Federico II University
VITELLIFORM LESIONS
Radiomic Analysis in OCT Imaging of Acquired Vitelliform Lesions.
Vitelliform lesions (VLs) are subretinal accumulations of yellowish material on fundoscopy that correspond to hyperautofluorescent material on fundus autofluorescence (FAF) and hyperreflective subretinal material on structural…
- Trial name
- NCT07074041
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Federico II University
Hodgkin Disease, Breast Cancer
Breast Cancer Risk Investigation in Grown-up Hodgkin Lymphoma Patients Treated With MBVD. Multicenter Retrospective Study on ≥200 Adult Female HL Patients Treated With ≥1 MBVD Cycle (NPLD, Bleomycin, Vinblastine, Dacarbazine). It Investigates Breast Cancer Incidence Post-treatment.
This is a multicenter retrospective cohort study conducted at the Hematology Unit of the University of Naples Federico II and the Hematology Department of AORN Cardarelli, Naples, Italy.
- Conditions
- Hodgkin Disease, Breast Cancer, Liposomal Doxorubicin
- Trial name
- BRIGHT-MBVD (NCT07120217)
- Volunteers
- 200 people
- Sponsor
- Federico II University
Obesity, Type2diabetes
Susceptibility to Infectious Diseases in obEsity: an endocRine trAnslational socioLogic Evaluation, "SIDERALE"
Obesity is a life-threatening disease, defined by excessive fat accumulation that increases the risk of other diseases such as cardiovascular events, hypertension, diabetes and cancer.
- Conditions
- Obesity, Type2diabetes, Lipodystrophy, Infections
- Trial name
- SIDERALE2020 (NCT06236932)
- Testing
- Mediterranean diet, Melatonin supplementation
- Where
- 4 sites in Italy
- Volunteers
- 100 people
- Sponsor
- Federico II University
Long Covid-19
LOng COvid COmorbidities: Andrological, Reproductive, Sexual Dysfunctions in Patients Recovered From COVID-19
Considering the compelling amount of studies focused on patients in the active phase of COVID-19 disease and the scarcity of studies focused on patient cured from disease aimed at evaluating the sequelae of Severe Acute…
- Trial name
- NCT05379556
- Testing
- Assessment of andrological profile of LO-COCO-ANDRO male patients, Assessment of reproductive function of LO-COCO-ANDRO male patients, Assessment of sexual function of LO-COCO-ANDRO male patients
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Federico II University
Hypertension; Heart Disease, Hypertensive
Registro Campania Salute Network on Hypertension
The Registro Campania Salute Network (RCSN) is a prospective registry aimed at improving the management of essential hypertension by integrating the activity of general practitioners (GPs) with that of the hypertension…
- Trial name
- RCSN (NCT02211365)
- Where
- Italy
- Volunteers
- 10,000 people
- Sponsor
- Federico II University
Long Covid-19
LOng COvid COmorbidities: Endocrine,Metabolic,Neuropsychiatric,Muscle,Cardiovascular,Pulmonary,Dermatologic Dysfunctions
Considering the compelling amount of studies focused on patients in the active phase of COVID-19 disease and the scarcity of studies focused on patient cured from disease aimed at evaluating the sequelae of SARS-CoV-2 infection…
- Trial name
- LO-COCO (NCT05293366)
- Testing
- Assessments of endocrinological phenotypes of LO-COCO patients, Assessment of muscular phenotypes of LO-COCO patients, Assessment of neuropsychiatric phenotypes of LO-COCO patients
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Federico II University
Percutaneous Coronary Intervention
Pharmacodynamic Effects of Cangrelor in ACS or CCS Patients Undergoing PCI (POMPEII Registry)
This prospective registry was designed to carefully investigate the pharmacodynamic (PD) effects of cangrelor in all patients undergoing percutaneous coronary intervention (PCI).
- Trial name
- POMPEII (NCT04790032)
- Testing
- Cangrelor
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Federico II University
Presence of Retinal Fluid, Changes in Macular Pigment Optical Density
Aflibercept 8 mg for nAMD: Early Anatomical and Functional Changes
Neovascular age-related macular degeneration (nAMD) is one of the main causes of irreversible vision loss in older people worldwide.
- Trial name
- NCT07074054
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- Federico II University
Basal Cell Cancer, Eyelid Tumor
Dose-Modulated Sonidegib Therapy for Periocular Basal Cell Carcinoma
The goal of this clinical trial is to evaluate the safety, tolerability, and clinical outcomes of a dose-modulation strategy of Sonidegib in adult patients with locally advanced periocular basal cell carcinoma (laBCC) who are not…
- Conditions
- Basal Cell Cancer, Eyelid Tumor, Basal Cell Carcinoma (BCC), Basal Cell Carcinoma of the Head and Neck
- Trial name
- BCC-Sonidegib (NCT07068568)
- Testing
- Sonidegib
- Where
- Italy
- Volunteers
- 12 people
- Sponsor
- Federico II University