Clinical trials: sponsored by Federico II University
Hodgkin Lymphoma
Brentuximab Vedotin Combined With Bendamustine Supercharge, a Low-toxicity and Efficient Salvage Regimen for Primary Refractory or First-relapsed Classic Hodgkin Lymphoma: Long-term Results of a Retrospective Monocenter Study.
This is a retrospective, monocenter and non-interventional study. Data were retrospectively collected from all patients who completed the BV-Bs scheme in the time period between 1 September 2013 and 1 September 2023.
- Trial name
- HL_PR/R-B (NCT06295211)
- Testing
- observational
- Volunteers
- 32 people
- Sponsor
- Federico II University
Heart Failure
Management of Heart Failure in Italian Outpatients Clinics: Observational Study
OPTIMA-HF is an observational, cross-sectional, multicenter, real-life study conducted in two different clinical settings: HF outpatients' clinics of Italian University Hospitals and territorial Cardiology outpatients' services.
- Trial name
- OPTIMA-HF (NCT06287164)
- Testing
- Data collection
- Where
- Italy
- Volunteers
- 4,000 people
- Sponsor
- Federico II University
Periodontal Diseases, Periodontal Inflammation
Minimally Non Surgical Periodontal Therapy Compared to Traditional Approach
This study aims to evaluate the clinical results of non-surgical periodontal therapy performed with micro-instruments compared to traditional approach (standard curettes) after 6 months of follow-up.
- Trial name
- NCT05060601
- Testing
- Gracey micro-curettes, Standard Gracey curettes
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Federico II University
Hepatobiliary Neoplasm
Holographic Augmented Reality Versus Screen Visualisation of 3D Rendering Models for the Pre-operative Evaluation and Planning of Liver Resections
The goal of this trial is to compare the evaluation of 3D liver models visualised as holograms with HoloLens 2 and on digital PDF files in HPB surgical trainees.
- Trial name
- NCT06049836
- Testing
- Holograms, PDF
- Where
- Italy
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Federico II University
Periodontal Bone Loss, Periodontal Pocket
Treatment of Intraosseous Periodontal Defects With Amelogenins
The aim of the present investigation will be evaluate the healing of periodontal intraosseous defects following Minimally Invasive Non Surgical Debridement (MINSD) and application of amelogenins, compared to MINSD alone.
- Trial name
- NCT05315804
- Testing
- MINSD and amelogenins, MINSD
- Where
- Italy
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Federico II University
Coronary Artery Disease, Acute Coronary Syndrome
Personalized Vs. Standard Duration of Dual Antiplatelet Therapy and New-generation Polymer-Free vs- Biodegradable-Polymer DES
New-generation metallic drug-eluting stents represent the standard of care among patients undergoing percutaneous coronary intervention (PCI).
- Conditions
- Coronary Artery Disease, Acute Coronary Syndrome, Chronic Coronary Syndrome, Myocardial Infarction
- Trial name
- PARTHENOPE (NCT04135989)
- Testing
- Percutaneous coronary intervention with implantation of amphilimus-eluting stents for coronary artery disease., Percutaneous coronary intervention with implantation of everolimus-eluting stents for coronary artery disease., Personalized DAPT duration
- Where
- 13 sites in Italy
- Volunteers
- 2,106 people
- Sponsor
- Federico II University
Acute Coronary Syndrome, Angiographic Evidence if Coronary Aneurysms
The Italian Coronary Artery Aneurysm and Ectasia In Patients With Acute Coronary Syndrome
The ITACA study is a prospective, observational no profit registry enrolling patients with Acute Coronary Syndrome and angiographic evidence of coronary aneurysms and/or ectasia.
- Conditions
- Acute Coronary Syndrome, Angiographic Evidence if Coronary Aneurysms, Ectasia
- Trial name
- ITACA (NCT05051917)
- Where
- 2 sites in Italy
- Volunteers
- 500 people
- Sponsor
- Federico II University
Coronary Artery Disease
Effects of Guiding Catheter on FFR and NHPR for the Assessment of Coronary Artery Stenoses (Disengage@Rest)
The DISENGAGE@rest study is a prospective registry carried out at Federico II University of Naples with the aim to evaluate the influence of the guiding catheter engagement within the coronary ostium on both FFR and…
- Trial name
- Disengage@Rest (NCT04975425)
- Testing
- Fractional Flow Reserve
- Where
- Italy
- Volunteers
- 200 people
- Sponsor
- Federico II University
Aortic Stenosis, Transcatheter Aortic Valve Replacement
EffecTAVI Registry
Aortic stenosis (AS) is the most common valvular heart disease among elderly population, with a increasing prevalence due to population ageing.
- Conditions
- Aortic Stenosis, Transcatheter Aortic Valve Replacement, TAVI
- Trial name
- NCT05235555
- Testing
- Transcatheter heart valve (THV) with CE approval
- Where
- Italy
- Volunteers
- 1,000 people
- Sponsor
- Federico II University
Acute Coronary Syndrome, Diabetes Mellitus
Platelet Aggregation in Diabetic Patients With Acute Coronary Syndrome Treated With Different Doses of Aspirin
Diabetes is an important risk factor of coronary atherosclerosis, and it's well known that platelets of diabetic patients are hyper reactive and so resistant to common antithrombotic therapy.
- Trial name
- DIABE-ASACS (NCT05293808)
- Testing
- aspirin 100 mg bis in die, aspririn 200 mg once daily, aspirin 100 mg once daily
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Federico II University
Coronary Artery Disease, Percutaneous Coronary Intervention
Naples PCI Registry
The aim of the Naples PCI registry is to collect prospective data on baseline clinical, laboratory, and angiographic characteristics of patients undergoing PCI for acute or chronic coronary artery disease.
- Conditions
- Coronary Artery Disease, Percutaneous Coronary Intervention, Myocardial Ischemia, Myocardial Infarction
- Trial name
- NCT05248165
- Testing
- PCI
- Where
- Italy
- Volunteers
- 5,000 people
- Sponsor
- Federico II University
Allergy Milk
Step Down Approach in Children With Cow Milk Allergy
Cow's milk allergy (CMA) affects up to 3% of European children. In the absence of an alternative to cow's milk, the management of CMA is based on the use of safe, affordable and nutritionally adequate formulas.
- Trial name
- SDACMA (NCT03449537)
- Testing
- extensively hydrolyzed casein formula + LGG, Hypoallergenic formula based on amino-acid based formula
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Federico II University
Allergy Milk
Tolerability of Hypoallergenic Formula in Children With Cow's Milk Allergy
Cow's milk protein allergy is defined as an immunological reaction to one or more milk proteins. A variety of symptoms can be suggestive for cow's milk protein allergy .
- Trial name
- SINEALLII (NCT03909113)
- Testing
- amino acid based formula
- Where
- Italy
- Volunteers
- 29 people
- Sponsor
- Federico II University
Type1diabetes
Management of Prolonged Aerobic exeRcise in Patients With Type 1 Diabetes on Advanced Technologies
The purpose of this study is to compare three different therapeutic and nutritional approaches during a prolonged aerobic exercise in moderately active type 1 diabetes people using advanced technologies, to identify the best…
- Trial name
- MARTA-walk (NCT05936203)
- Testing
- Insulin therapy adjustment, Nutritional adjustment, Combination of strategies
- Where
- Italy
- Volunteers
- 18 people
- Sponsor
- Federico II University
Invasiveness, Neoplasm
KLHL14 Expression as Predicting Factor of Invasiveness in pitNET
OBJECTIVE: The objective of this study is to evaluate the correlation between KLHL14 expression and its cytoplasm-nuclear localisation and pituitary adenomas biological behaviour with particular focus on its role in epithelial…
- Trial name
- NCT06247709
- Testing
- Immunohistochemical expression in pitNET cells of KLHL14
- Where
- Italy
- Volunteers
- 12 people
- Sponsor
- Federico II University
Glucose Metabolism Disorders, Overweight or Obesity
Metabolic Effects of Oral Sodium Butyrate Supplementation on Overweight Individuals
Numerous evidences suggest an important role of short-chain fatty acids, produced by the intestinal fermentation of dietary fibers by the intestinal microbiota, in the modulation of various biological functions relevant to human…
- Trial name
- NCT06247020
- Testing
- Supplementation with sodium- butyrrate
- Where
- Italy
- Volunteers
- 14 people
- Sponsor
- Federico II University
Classic Hodgkin Lymphoma
Liposomal Doxorubicin-containing Front-line Treatment in Elderly Patients With HL (HL-MVD)
Study on the use of a polychemotherapy scheme based on liposomal doxorubicin, vinblastine and dacarbazine (MVD) as first line in the therapy of elderly patients affected by classic Hodgkin lymphoma
- Trial name
- NCT06235047
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Federico II University
IBD
From Nature to Bedside- Algae Based Bio Compound for Prevention and Treatment of Inflammation, Pain and IBD
This study is part of the project funded by the Horizon2020 program for establishing the consortium Algae4IBD (https://algae4ibd.eu/), where Dept.
- Trial name
- Algae4IBD (NCT06227598)
- Testing
- Procedure: Additional biopsies collection
- Volunteers
- 90 people
- Sponsor
- Federico II University
Mild Cognitive Impairment
Effects of a Nutraceutic Compound on Cognitive Impairment
The study is designed to evaluate the effects of choline bitartrate on cognitive impairment in frailty patients. The study will analyze the impact of 4 weeks treatment randomized with a nutraceutical compound in a double-blind…
- Trial name
- ENUCCI (NCT06200883)
- Testing
- Choline Bitartrate
- Where
- Italy
- Volunteers
- 58 people
- Sponsor
- Federico II University
Type 2 Diabetes
Individual Determinants of Postprandial Glucose Response in Type 2 Diabetes
Postprandial glycemia (PPG) is a relevant determinant of glucose control in people with type 2 diabetes (T2D). Epidemiological and pathophysiological studies indicate that PPG is a better risk predictor for cardiovascular disease…
- Trial name
- DIABEST (NCT06057246)
- Testing
- Test meal with postprandial samples
- Where
- Italy
- Volunteers
- 144 people
- Sponsor
- Federico II University