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Promozione della Salute, Materno-Infantile, di Medicina Interna e Specialistica di Eccellenza “G. D’Alessandro”

Studi Clinici Osservazionali

Trial in corso

[Dati estratti dai DB internazionali www.clinicaltrials.gov e www.clinicaltrialsregister.eu]

[L'elenco considera tutti i Trial che sono in corso di svolgimento nell'anno corrente, cioè la cui scadenza effettiva/stimata cade nell'anno corrente o in anno successivo]

[#TOT Trial in corso: 125] - [ultimo aggiornamento: 26/01/2026]

Title	A prospective, observational cohort study to evaluate the clinical impact of novel monoclonal antibodies (MAB) in B-cell Non-Hodgkin Lymphoma (NHL) in Italian clinical practice. Studio di coorte osservazionale prospettico per valutare nei pazienti con linfoma non-Hodgkin a cellule B l’impatto clinico dei nuovi anticorpi monoclonali MAB nella pratica clinica italiana.
NCT number	NCT06008691 FIL-MAB
Conditions	Non-Hodgkin Lymphoma, B-cell
Interventions	Drug: "novel" MAB (alone or in combination)
Sponsor	Fondazione Italiana Linfomi - ETS
Gender	Female; Male
Age	18 Years and older (Adult, Older Adult )
Phases
Enrollment	1500
Study Type	Observational
Study Designs	Observational Model : Cohort Time Perspective: Prospective
Start Date	27/12/2023
Completion Date	31/10/2038
Locations	Italy - A.O.U. Policlinico P. Giaccone Palermo, U.O.C. di Ematologia, Dott.^ssa Salvatrice Mancuso
URL	https://clinicaltrials.gov/study/NCT06008691

Study Title	Randomised Evaluation of COVID-19 Therapy (RECOVERY)
NCT Number	NCT04381936 Other Ids NDPHRECOVERY \| 2020-001113-21 \| 2023-507441-29-00 \| ISRCTN50189673
Conditions	Severe Acute Respiratory Syndrome
Interventions	DRUG: Lopinavir-Ritonavir\|DRUG: Corticosteroid\|DRUG: Hydroxychloroquine\|DRUG: Azithromycin\|BIOLOGICAL: Convalescent plasma\|DRUG: Tocilizumab\|BIOLOGICAL: Immunoglobulin\|DRUG: Synthetic neutralising antibodies\|DRUG: Aspirin\|DRUG: Colchicine\|DRUG: Baricitini
Sponsor	University of Oxford UK Research and Innovation\|National Institute for Health Research, United Kingdom\|Wellcome Trust \| Bill and Melinda Gates Foundation \| Department for International Development, United Kingdom \| Health Data Research UK \| Medical Research Council Population Health Research Unit \| NIHR Health Protection Research Unit in Emerging and Zoonotic Infections \| Flu Lab
Sex	ALL
Age	CHILD, ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	70000
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED \| Intervention Model: FACTORIAL \| Masking: NONE \| Primary Purpose: TREATMENT
Start Date	19/03/2020
Completion Date	30/06/2036
Locations	Prof. Antonio Cascio, UOC di Malattie Infettive - AOU Policlinico "P. Giaccone"
Study URL	https://clinicaltrials.gov/study/NCT04381936

Study Title	ConTempoRary Cardiac Stimulation in Clinical practicE: lEft, BivEntriculAr, Right, and conDuction System Pacing
NCT Number	NCT06324682 Other IDs: 825/2022/Oss/AOUFe
Conditions	Arrhythmias, Cardiac\|Atrioventricular Block\|Reduced Systolic Function\|Atrial Fibrillation\|Bradyarrhythmia\|Ventricular Tachycardia\|Ventricular Dysfunction\|Ventricular Fibrillation\|Ventricular Arrythmia\|Atrioventricular Nodal Disease\|Atrioventricular Conduction Defects\|Atrioventricular Block Complete\|Atrioventricular Block Incomplete\|Atrioventricular Junctional Rhythm\|Bundle-Branch Block\|Left Bundle-Branch Block\|Heart Failure, Systolic\|Block;Atrioventricular\|Block; Arrhythmic\|Block; Mobitz\|Block, Heart\|Block, Fascicular\|Block Branch Bundle Left\|Heart Failure，Congestive\|Heart Arrhythmia
Interventions	DEVICE: Cardiac pacing - Conventional RV pacing\|DEVICE: Cardiac pacing - Conduction System Pacing\|DEVICE: Cardiac pacing - Cardiac resynchronization therapy (pacing - CRTP - or defibrillation - CRTD)\|DEVICE: Cardiac pacing - Epicardial pacing\|DEVICE: Cardiac pacing - Leadless pacing
Sponsor	University Hospital of Ferrara
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases
Enrollment	8400
Study Type	OBSERVATIONAL
Study Design	Observational Model: \|Time Perspective: p
Start Date	01/01/2023
Completion Date	31/12/2034
Locations	Ospedale Civico, azienda Ospedaliera di Palermo, Palermo, Italy\| Policlinico Paolo Giaccone, Palermo, Italy, Giuseppe Coppola (docente Ente convenzionato PROMISE)
Study URL	https://clinicaltrials.gov/study/NCT06324682

Study Title	Lynch Syndrome X-Talk of Enteral Mucosa With Immune System
NCT Number	NCT06708429 Other IDs: LYNX EYE 2023
Conditions	Lynch Syndrome\|Lynch Syndrome I\|Lynch Syndrome II\|Lynch Syndrome I (Site-specific Colonic Cancer)\|HNPCC\|HNPCC Gene Mutation\|Hereditary Cancer Syndrome\|Hereditary Cancer\|MLH1 Gene Mutation\|MLH1 Gene Deletion+Duplication\|MLH1 Loss of Expression\|MLH1 Gene Inactivation\|MSH2 Gene Mutation\|MSH2 Gene Deletion+Duplication\|MSH2 Loss of Expression\|MSH2 Gene Inactivation\|MSH6 Gene Mutation\|MSH6 Loss of Expression\|MSH6 Gene Inactivation\|PMS2 Gene Mutation\|PMS2 Gene Inactivation\|PMS2 Loss of Expression
Interventions	DIAGNOSTIC_TEST: LYNX EYE (Lynch syndrome X-Talk of Enteral mucosa with Immune System)
Sponsor	San Raffaele University
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases
Enrollment	300
Study Type	OBSERVATIONAL
Study Design	Observational Model: \|Time Perspective: p
Start Date	06/01/2023
Completion Date	06/01/2034
Locations	Dipartimento di controllo qualità e rischio chimico biologico, AOOR Villa Sofia Cervello, Palermo, PM, Italy, Francesca Di Gaudio
Study URL	https://clinicaltrials.gov/study/NCT06708429

Title	Multicenter, Nationwide, Observational, Prospective Study Based on the Development of a Primary Sclerosing Cholangitis Patients Database Linked to a Biological Sample Storage
NCT Number	NCT05618145 PSC_Database
Conditions	Primary Sclerosing Cholangitis
Interventions	Other: Clinical information
Sponsor	University of Milano Bicocca
Gender	All
Age	17 Years and older (Child, Adult, Older Adult)
Phases
Enrollment	6000 participants
Study Type	Observational
Study Designs	Cohort
Start Date	21/10/2022
Completion Date	21/10/2032
Locations	A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. Gastroenterologia, prof.^ssa Vincenza Calvaruso
URL	https://www.clinicaltrials.gov/ct2/show/NCT05618145

Study Title	A Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Who Are Ineligible for Autologous
NCT Number	NCT06679101 214828\|2024-516030-35 (TI-NDMM) DREAMM-10
Conditions	Multiple Myeloma\|Newly Diagnosed Multiple Myeloma
Interventions	DRUG: Belantamab mafodotin\|DRUG: Lenalidomide\|DRUG: Dexamethasone\|DRUG: Daratumumab
Sponsor	Glaxo Smith Kline
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	520
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: NONE\|Primary Purpose: TREATMENT
Start Date	27/12/2024
Completion Date	06/04/2032
Locations	A.O.U. Policlinico P. Giaccone Palermo, Dott. Cirino Botta, U.O.C. di Ematologia, GSK Investigational Site, Ancona, Italy\|GSK Investigational Site, Meldola FC, 47014, Italy\|GSK Investigational Site, Roma, 00161, Italy
Study URL	https://clinicaltrials.gov/study/NCT06679101

Title	A Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Navitoclax in Combination with Ruxolitinib Versus Best Available Therapy in Subjects with Relapsed/Refractory Myelofibrosis (TRANSFORM-2) Studio Clinico Randomizzato, In Aperto di Fase 3 per Valutare l’Efficacia e la Sicurezza di Navitoclax in Combinazione con Ruxolitinib rispetto alla Miglior Terapia Disponibile in Soggetti Affetti da Mielofibrosi Recidivante/Refrattaria
EudraCT number	2020-000557-27 TRANSFORM-2 M20-178
Conditions	Myelofibrosis Mielofibrosi
Interventions
Sponsor	ABBVIE DEUTSCHLAND GMBH & CO. KG
Gender	Female; Male
Age	Adults; Elderly;
Phases	Phase III
Enrollment	330
Study Type	Therapeutic confirmatory (Phase III)
Study Designs	Controlled; Randomised; Open; Parallel group;
Start Date	27/10/2020
Completion Date	23/01/2032
Locations	United Kingdom Italy: A.O.U. Policlinico P. Giaccone Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL	https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-000557-27/IT

Study Title	Italian Anderson Fabry Disease Cardiovascular Registry
NCT Number	NCT06806813 Other IDs: RICMAF
Conditions	Fabry Disease
Interventions
Sponsor	IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sex	ALL
Age	CHILD, ADULT, OLDER_ADULT
Phases
Enrollment	800
Study Type	OBSERVATIONAL
Study Design	Observational Model: \|Time Perspective: p
Start Date	26/01/2022
Completion Date	31/12/2031
Locations	Antonino Tuttolomondo, U.O.C. Medicina Interna con Stroke Care, Policlinico P. Giaccone, Palermo, Sicilia/Palermo, 90127, Italy\|
Study URL	https://clinicaltrials.gov/study/NCT06806813

Study Title	LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis
NCT Number	NCT06632444 Other IDs: 1404-0044, AOUP P. Giaccone, Delibera n. 85-2025 - Prot. 6551-2025 2024-513739-25-00 U1111-1306-9071
Conditions	Metabolic Dysfunction Associated Steatohepatitis (MASH)\|Liver Fibrosis
Interventions	DRUG: Survodutide\|DRUG: Placebo
Sponsor	Boehringer Ingelheim
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	1800
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)\|Primary Purpose: TREATMENT
Start Date	14/10/2024
Completion Date	27/12/2031
Locations	Salvatore Petta, U.O.C. di Gastroenterologia e Epatologia, Policlinico "Paolo Giaccone", Palermo, 90127, Italy
Study URL	https://clinicaltrials.gov/study/NCT06632444

Title	A Phase 3 Randomized Study Comparing Teclistamab Monotherapy versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib,Dexamethasone (Kd) in Participants with Relapsed or Refractory Multiple Myeloma who have Received 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Monoclonal Antibody and Lenalidomide Uno studio randomizzato di fase 3 che confronta Teclistamab in monoterapia con pomalidomide, bortezomib, desametasone (PVd) o carfilzomib, desametasone (Kd) in partecipanti con mieloma multiplo recidivante o refrattario che hanno ricevuto da 1 a 3 linee terapeutiche precedenti, incluso un anticorpo monoclonale anti-CD38 e lenalidomide
EudraCT number	2022-000928-37 NCT05572515 6400795MMY3006 / MajesTEC-9 CR109244
Conditions	Multiple myeloma Mieloma multiplo
Interventions	Drug: Teclistamab Drug: Pomalidomide Drug: Bortezomib Drug: Dexamethasone Drug: Carfilzomib
Sponsor	JANSSEN CILAG INTERNATIONAL NV
Gender	Female; Male
Age	Adults; Elderly;
Phases	Phase III
Enrollment	650
Study Type	Therapeutic confirmatory (Phase III)
Study Designs	Controlled; Randomised; Open;
Start Date	02/09/2023
Completion Date	31/08/2031
Locations	A.O.U. Policlinico P. Giaccone Palermo, Dott. Cirino Botta, U.O.C. di Ematologia
URL	https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-000928-37/IT https://clinicaltrials.gov/study/NCT05572515

Study Title	A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
NCT Number	NCT06419374 2023-510395-31-00 BIO89-100-132 ORG-100030362
Conditions	Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
Interventions	BIOLOGICAL: Pegozafermin\|DRUG: Placebo
Sponsor	89bio, Inc.
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	762
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date	24/05/2024
Completion Date	01/08/2031
Locations	Salvatore Petta, U.O.C. di Gastroenterologia e Epatologia, Policlinico "Paolo Giaccone" Spain, Poland, Hungary, France, Netherlands, Italy, Germany, Bulgaria, Belgium
Study URL	https://clinicaltrials.gov/study/NCT06419374

Study Title	Study of Oral Navitoclax Tablet in Combination With Oral Ruxolitinib Tablet to Assess Change in Spleen Volume in Adult Participants With Relapsed/Refractory Myelofibrosis
NCT Number	NCT04468984 Other IDs: M20-178\|2020-000557-27
Conditions	Myelofibrosis (MF)
Interventions	DRUG: Navitoclax\|DRUG: Ruxolitinib\|DRUG: Best Available Therapy (BAT)
Sponsor	AbbVie
Gender	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	330
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: NONE\|Primary Purpose: TREATMENT
Start Date	31/08/2020
Completion Date	01/02/2031
Locations	U.O.C. di Ematologia, Prof. Sergio Siragusa, Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 221078, Palermo, 90127, Italy\|
Study URL	https://clinicaltrials.gov/study/NCT04468984

Study Title	Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
NCT Number	NCT06051617 Other Ids: CB8025-41837 \| 2024-516525-31-00
Conditions	Primary Biliary Cholangitis
Interventions	DRUG: Seladelpar\|DRUG: Placebo
Sponsor	Gilead Sciences
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	318
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)\|Primary Purpose: TREATMENT
Start Date	07/09/2023
Completion Date	01/08/2030
Locations	Prof.ssa Vincenza Calvaruso, A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. Gastroenterologia \| A.O.U. Pisana, U.O. Epatologia, Pisa, 56124, Italy
Study URL	https://clinicaltrials.gov/study/NCT06051617

Study Title	A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis
NCT Number	NCT06470048 CVAY736S12201 2024-511933-36-00
Conditions	Diffuse Cutaneous Systemic Sclerosis
Interventions	DRUG: Placebo\|DRUG: Ianalumab
Sponsor/Collaborators	Novartis Pharmaceuticals
Gender	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE2
Enrollment	200
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date	09/10/2024
Completion Date	15/07/2030
Locations	Azienda Ospedaliero Universitaria Policlinico P. Giaccone, Palermo, UOC di Reumatologia, Prof.^ssa Giuliana Guggino
Study URL	https://clinicaltrials.gov/study/NCT06470048

Study Title	A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)
NCT Number	NCT01848561 Other IDs: P11-282
Conditions	Ulcerative Colitis (UC)
Interventions
Sponsor	AbbVie
Gender	ALL
Age	ADULT, OLDER_ADULT
Phases
Enrollment	8250
Study Type	OBSERVATIONAL
Study Design	Observational Model: \|Time Perspective: p
Start Date	29/04/2013
Completion Date	24/06/2030
Locations	Dott.ssa Maria Cappello, Gastroenterologia , Direttore Prof. Calogero Cammà, Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 141397, Palermo, 90127, Italy\| A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 141392, Palermo, 90146, Italy\|
Study URL	https://clinicaltrials.gov/study/NCT01848561

Study Title	AutoInflammatory Disease Alliance Registry (AIDA)
NCT Number	NCT05200715 Other IDs: AIDA V.04 19.05.2021
Conditions	Hereditary Autoinflammatory Diseases\|Schnitzler Syndrome\|Behcet Syndrome\|PFAPA Syndrome\|Still Disease\|Autoinflammatory Syndrome, Unspecified\|Uveitis\|Scleritis\|Vexas Syndrome
Interventions	OTHER: No intervention is foreseen by the protocol.
Sponsor	University of Siena
Gender	ALL
Age	CHILD, ADULT, OLDER_ADULT
Phases
Enrollment	3500
Study Type	OBSERVATIONAL
Study Design	Observational Model: \|Time Perspective: p
Start Date	08/06/2020
Completion Date	08/06/2030
Locations	ARNAS Ospedale Civico di Cristina Benfratelli, Palermo, Italy\| Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy\| prof.^ssa Maria Cristina Maggio, University Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties (PROMISE) “G. D’Alessandro”, University of Palermo, Palermo, Italy\|
Study URL	https://clinicaltrials.gov/study/NCT05200715 https://aidanetwork.org/it/

Study Title	Nipocalimab in Moderate to Severe Sjogren's Disease (DAFFODIL)
NCT Number	NCT06741969 Other IDs 80202135SJS3001 \| 80202135SJS3001 \| 2024-513965-38-00 \| DAFFODIL
Conditions	Sjogrens Syndrome
Interventions	DRUG: Nipocalimab\|DRUG: Placebo\|DRUG: Standard of care treatment
Sponsor	Janssen Research & Development, LLC
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	600
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date	04/12/2024
Completion Date	17/04/2030
Locations	Prof.ssa Giuliana Guggino, Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone, Palermo, 90127, Italy Ospedale San Raffaele, Milan, 20132, Italy\|Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO, Milan, 20122, Italy\|Azienda Ospedali
Study URL	https://clinicaltrials.gov/study/NCT06741969

Study Title	A Combination of Rituximab and CC-99282 as Front-line Therapy for Older Frail Patients With Diffuse Large B-cells Non-Hodgkin Lymphoma Evaluated With a Simplified Geriatric Assessment (sGA): a Phase II Study of the Fondazione Italiana Linfomi (FIL)
NCT Number	NCT06835530 Other IDs: FIL_RICCO\|2023-506206-38-00
Conditions	Diffuse Large B Cell Non-Hodgkin Lymphoma
Interventions	DRUG: Rituximab + Golcadomide (CC-99282)
Sponsor	Fondazione Italiana Linfomi - ETS
Sex	ALL
Age	OLDER_ADULT
Phases	PHASE2
Enrollment	47
Study Type	INTERVENTIONAL
Study Design	Allocation: NA\|Intervention Model: SINGLE_GROUP\|Masking: NONE\|Primary Purpose: TREATMENT
Start Date	01/04/2025
Completion Date	01/04/2030
Locations	Prof.ssa Salvatrice Mancuso, Policlinico Giaccone - Ematologia, Palermo, Italy
Study URL	https://clinicaltrials.gov/study/NCT06835530

Study Title	Phase III Study of Rilvegostomig in Combination With Bevacizumab With or Without Tremelimumab as First-line Treatment of Hepatocellular Carcinoma
NCT Number	NCT06921785 Other Ids: D7029C00001; EUCT: 2024-518210-81-00
Conditions	Hepatocellular Carcinoma
Interventions	DRUG: Tremelimumab\|DRUG: Rilvegostomig\|DRUG: Bevacizumab\|DRUG: Atezolizumab
Sponsor/Collaborators	AstraZeneca
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	1220
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: SINGLE (OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date	06/05/2025
Completion Date	14/03/2030
Locations	Prof. Calogero Camma', UO gastroenterologia, Azienda Ospedaliera Universitaria Paolo Giaccone, Research Site, Palermo, 90127, Italy
Study URL	https://clinicaltrials.gov/study/NCT06921785

Study Title	Real-World Mapping Antithrombotic Regimens in MM Patients on Treatment
NCT Number	NCT06028087 Other IDs GIMEMA ET0123 \| MARMMOT
Conditions	Multiple Myeloma \| Diagnosis
Interventions
Sponsor	GIMEMA - Gruppo Italiano Malattie EMatologiche dell'Adulto
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases
Enrollment	736
Study Type	OBSERVATIONAL
Study Design	Observational Model: \|Time Perspective: p
Start Date	10/03/2025
Completion Date	01/03/2030
Locations	Prof. Sergio Siragusa, U.O.C. di Ematologia, Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 221078, Palermo, 90127, Italy Fondazione Policlinico Universitario A. Gemelli IRCCS UOC Servizio e DH di Ematologia, Roma, Italy
Study URL	https://clinicaltrials.gov/study/NCT06028087

Study Title	Fosfomycin I.v. for Treatment of Severely Infected Patients
NCT Number	NCT02979951 Other IDs: FORTRESS
Conditions	Bacterial Infections\|Bone Diseases, Infectious\|Osteomyelitis\|Central Nervous System Bacterial Infections\|Meningitis, Bacterial\|Encephalitis\|Brain Abscess\|Urinary Tract Infections\|Respiratory Tract Infections\|Pneumonia, Bacterial\|Skin Diseases, Bacterial\|Soft Tissue Infections\|Intraabdominal Infections\|Sepsis\|Bacteremia\|Endocarditis, Bacterial
Interventions
Sponsor	Sponsor: Infectopharm Arzneimittel GmbH - Collaborators: INPADS GmbH\|Dr. Oestreich + Partner GmbH
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases
Enrollment	1000
Study Type	OBSERVATIONAL
Study Design	Observational Model: \|Time Perspective: p
Start Date	12/01/2016
Completion Date	12/01/2030
Locations	Istituto Mediterraneo per i Trapianti Ismett IRCCS, Palermo, Italy\| Policlinico Paolo Giaccone, Palermo, Italy, Antonio Cascio
Study URL	https://clinicaltrials.gov/study/NCT02979951

Study Title	Shortened vs Standard Chemotherapy Combined With Immunotherapy for the Initial Treatment of Patients With High Tumor Burden Follicular Lymphoma
NCT Number	NCT05058404 Other IDs: FIL_FOLL19
Conditions	Follicular Lymphoma
Interventions	DRUG: Immunochemotherapy regimen: Rituximab-bendamustine (Arm A)\|DRUG: Immunochemotherapy regimen: Rituximab-bendamustine (Arm B)\|DRUG: Immunochemotherapy regimen: R-CHOP (Arm A)\|DRUG: Immunochemotherapy regimen: R-CHOP (Arm B)\|DRUG: Immunochemotherapy regimen: G-bendamustine (Arm A)\|DRUG: Immunochemotherapy regimen: G-bendamustine (Arm B)\|DRUG: Immunochemotherapy regimen: G-CHOP (Arm A)\|DRUG: Immunochemotherapy regimen: G-CHOP (Arm B)\|DRUG: Immunochemotherapy regimen: G-CVP (Arm A)\|DRUG: Immunochemotherapy regimen: G-CVP (Arm B)
Sponsor	Fondazione Italiana Linfomi - ETS
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	602
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: NONE\|Primary Purpose: TREATMENT
Start Date	12/01/2021
Completion Date	07/01/2030
Locations	AOU Policlinico Giaccone - Ematologia, Palermo, 90127, Italy, Salvatrice Mancuso, MD\| A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia, Palermo, 90146, Italy
Study URL	https://clinicaltrials.gov/study/NCT05058404

Study Title	A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease
NCT Number	NCT07064473 Other IDs: 1378-0041\|U1111-1319-9064\|2025-521188-11-00
Conditions	Diabetes Mellitus, Type 2\|Hypertension\|Cardiovascular Diseases
Interventions	DRUG: Vicadrostat\|DRUG: Empagliflozin\|DRUG: Placebo matching Vicadrostat
Sponsor/Collaborators	Boehringer Ingelheim
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	11800
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date	22/07/2025
Completion Date	21/12/2029
Locations	Prof. Antonino Tuttolomondo, U.O.C. Medicina Interna con Stroke Care, Policlinico P. Giaccone, Palermo, Sicilia/Palermo, 90127, Italy
Study URL	https://clinicaltrials.gov/study/NCT07064473

Study Title	Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes
NCT Number	NCT06008756 Other IDs: 0616-015\|jRCT2071230064\|2022-502781-24-00\|U1111-1285-4245
Conditions	Arteriosclerosis\|Hypercholesterolaemia
Interventions	DRUG: Enlicitide Decanoate\|DRUG: Placebo
Sponsor	Merck Sharp & Dohme LLC
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	14550
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date	09/10/2023
Completion Date	29/11/2029
Locations	Palermo, Sicilia, Italy, 90129, A.O.U. Policlinico Paolo Giaccone ( Site 1815) Contact : Prof. Angelo Baldassare Cefalù Study Coordinator: 0039-0916554338
Study URL	https://clinicaltrials.gov/study/NCT06008756

Title	Shortened vs standard chemotherapy combined with immunotherapy for the initial treatment of patients with high tumor burden Follicular Lymphoma. A randomized, open label, phase III study by Fondazione Italiana Linfomi. Trattamento combinato di immunochemioterapia standard vs immunoterapia standard e chemioterapia a ridotto numero di cicli per il trattamento in prima linea di pazienti con Linfoma Follicolare ad elevato carico tumorale. Studio randomizzato in aperto di fase III della Fondazione Italiana Linfomi.
EudraCT number	2020-003277-22 FIL FOLL 19
Conditions	High tumor burden Follicular Lymphoma Linfoma Follicolare ad elevato carico tumorale
Interventions
Sponsor	FONDAZIONE ITALIANA LINFOMI ONLUS
Gender	Female; Male
Age	Adults; Elderly;
Phases	Phase III
Enrollment	602
Study Type	Therapeutic confirmatory (Phase III)
Study Designs	Controlled; Randomised; Open;
Start Date	10/04/2021
Completion Date	25/10/2029
Locations	Italy - A.O.U. Policlinico P. Giaccone Palermo, U.O.C. di Ematologia, Dott.^ssa Salvatrice Mancuso
URL	https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-003277-22/IT

Study Title	LIVERAGE - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis
NCT Number	NCT06632457 1404-0064 2024-513741-36-00 U1111-1307-0227
Conditions	Metabolic Dysfunction Associated Steatohepatitis
Interventions	DRUG: Survodutide DRUG: Placebo matching survodutide
Sponsor	Boehringer Ingelheim
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	1590
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)\|Primary Purpose: TREATMENT
Start Date	12/11/2024
Completion Date	05/06/2029
Locations	A.O.U. Policlinico P. Giaccone Palermo, Prof. Salvatore Petta, U.O.C. di Gastroenterologia
Study URL	https://clinicaltrials.gov/study/NCT06632457

Study Title	Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH)
NCT Number	NCT04822181 NN9931-4553 U1111-1244-3678 2019-004594-44 jRCT2031210033
Conditions	Non-alcoholic Steatohepatitis
Interventions	DRUG: Semaglutide\|DRUG: Placebo
Sponsor	Novo Nordisk A/S
Gender	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	1200
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)\|Primary Purpose: TREATMENT
Start Date	04/01/2021
Completion Date	25/04/2029
Locations	AOUP Giaccone Palermo, Palermo, 90127, Italy\|
Study URL	https://clinicaltrials.gov/study/NCT04822181

Study Title	Study to Check the Safety of Fazirsiran and Learn if Fazirsiran Can Help People With Liver Disease and Scarring (Fibrosis) Due to an Abnormal Version of Alpha-1 Antitrypsin Protein Studio di fase 3, randomizzato, in doppio cieco, controllato con placebo, per valutare l'efficacia e la sicurezza di Fazirsiran nel trattamento della malattia epatica associata a deficit di alfa 1-antitripsina con fibrosi di stadio METAVIR da F2 a F4
NCT Number	NCT05677971 Protocollo: TAK-999-3001 2022-501943-34-00
Conditions	Alpha1-Antitrypsin Deficiency
Interventions	DRUG: Fazirsiran Injection\|OTHER: Placebo
Sponsor	Takeda Development Center Americas, Inc.
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	160
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date	06/03/2023
Completion Date	31/03/2029
Locations	A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. Gastroenterologia, prof.^ssa Vincenza Calvaruso
Study URL	https://clinicaltrials.gov/study/NCT05677971

Study Title	Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
NCT Number	NCT04954859 206882 2023-506867-33-01
Conditions	Hepatitis B
Interventions	DRUG: Bepirovirsen\|DRUG: Placebo
Sponsor	GlaxoSmithKline
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE2
Enrollment	450
Study Type	INTERVENTIONAL
Study Design	Allocation: NON_RANDOMIZED\|Intervention Model: PARALLEL\|Masking: NONE\|Primary Purpose: TREATMENT
Start Date	14/12/2021
Completion Date	08/02/2029
Locations	A.O.U. Policlinico P. Giaccone Palermo, prof.Vito Di Marco GSK Investigational Site, Milan, 20122, Italy\|GSK Investigational Site, Milan, 20157, Italy\|GSK Investigational Site, Modena, 40126, Italy\|
Study URL	https://clinicaltrials.gov/study/NCT04954859

Title	A randomised, double-blind, placebo-controlled, multicentre, Phase 3 study evaluating long-term efficacy and safety of lanifibranor in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosis Studio di Fase 3, randomizzato, in doppio cieco, controllato con placebo, multicentrico, per la valutazione dell’efficacia e della sicurezza a lungo termine di lanifibranor in pazienti adulti affetti da steatoepatite non alcolica (NASH) non cirrotica e da fibrosi epatica di stadio 2 (F2) e di stadio 3 (F3)
EudraCT number	2020-004986-38
Conditions	Non-alcoholic Steatohepatitis (NASH) Steatoepatite non alcolica (NASH)
Interventions
Sponsor/Collaborators	INVENTIVA S.A.
Gender	Female; Male
Age	Adults; Elderly;
Phases	Phase III
Enrollment	2000
Study Type	Therapeutic confirmatory (Phase III)
Study Design	Controlled; Randomised; Parallel group;
Start Date	05/02/2022
Completion Date	03/02/2029
Locations	France - A.O.U. Policlinico P. Giaccone Palermo, PETTA SALVATORE
URL	https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-004986-38/IT

Study Title	A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
NCT Number	NCT06318169 Other Ids: BIO89-100-131; EUCT: 2023-509912-27-00
Conditions	Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
Interventions	BIOLOGICAL: Pegozafermin\|OTHER: Placebo
Sponsor/Collaborators	89bio, Inc.
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	1350
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date	13/03/2024
Completion Date	01/02/2029
Locations	Prof. Salvatore Petta, U.O.C. di Gastroenterologia e Epatologia, Policlinico "Paolo Giaccone", 89bio Clinical Study Site, Palermo, 90127, Italy
Study URL	https://clinicaltrials.gov/study/NCT06318169

Study Title	National Database on Primary Biliary Cholangitis
NCT Number	NCT05151809
Conditions	Primary Biliary Cholangitis
Interventions	OTHER: Clinical information
Sponsor	University of Milano Bicocca
Gender
Age
Phases
Enrollment	6000
Study Type	OBSERVATIONAL
Study Design	Observational Model: \|Time Perspective: p
Start Date	19/09/2019
Completion Date	24/01/2029
Locations	UO gastroenterologia, Policlinico Paolo Giaccone, Palermo, Italy, prof. Calogero Cammà
URL	https://clinicaltrials.gov/study/NCT05151809

Study Title	A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis
NCT Number	NCT06016842 CLIN-60190-454 2023-505251-43-00
Conditions	Primary Biliary Cholangitis (PBC)
Interventions	DRUG: Elafibranor\|OTHER: Matched 80 mg placebo
Sponsor	Ipsen
Gender	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	276
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date	31/08/2023
Completion Date	05/01/2029
Locations	prof.^ssa Vincenza Calvaruso, U.O.C. Gastroenterologia, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo, Italy\|
Study URL	https://clinicaltrials.gov/study/NCT06016842

Study Title	A Real-life Observational Study in Severe Eosinophilic Asthma Adult Participant Treated With Benralizumab in Italy
NCT Number	NCT07214753 Other Ids: D3250R00141
Conditions	Severe Eosinophilic Asthma
Interventions	BIOLOGICAL: benralizumab
Sponsor/Collaborators	AstraZeneca
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases
Enrollment	335
Study Type	OBSERVATIONAL
Study Design	Observational Model: \|Time Perspective: p
Start Date	20/12/2025
Completion Date	31/12/2028
Locations	Dott.ssa Alida Benfante, A O U Policlinico P. Giaccone, U.O.C. Pneumologia, Palermo, 90127, Italy
Study URL	https://clinicaltrials.gov/study/NCT07214753

Study Title	The AIRTIVITY® Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis
NCT Number	NCT06872892 Other IDs: 1397-0014\|2024-518589-29-00\|U1111-1317-2315
Conditions	Bronchiectasis
Interventions	DRUG: BI 1291583\|DRUG: Placebo matching BI 1291583
Sponsor	Boehringer Ingelheim
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	1680
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date	16/06/2025
Completion Date	10/12/2028
Locations	Nicola Scichilone, U.O. Pneumologia, Policlinico "Paolo Giaccone", Palermo, 90127, Italy\|
Study URL	https://clinicaltrials.gov/study/NCT06872892

Title	ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)
NCT Number	NCT03301506 - CB8025-31731 - Prot. Cb8025-31731-Re - Codice Eudract: 2020-005198-29
Conditions
Interventions	Parallel Assignment
Sponsor	CymaBay Therapeutics, Inc. Promotore: CymaBay Therapeutics, Inc. CRO: PPD Italy s.r.l.
Gender	All
Age	18 Years to 75 Years (Adult, Older Adult)
Phases
Enrollment	500 participants
Study Type	Interventional (Clinical Trial)
Study Designs	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Start Date	12/12/2017
Completion Date	30/11/2028
Locations	Sperimentatore: Prof.^ssa V. Calvaruso; Centro: U.O.C. di Gastroenterologia ed Epatologia A.O.U. Policlinico P. Giaccone di Palermo
URL	https://clinicaltrials.gov/ct2/show/NCT03301506

Study Title	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Retatrutide on the Incidence of Major Adverse Cardiovascular Events and Major Adverse Kidney Events in Participants with Body Mass Index ≥27 kg/m2 and Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease
NCT Number	NCT05882045 18582 J1I-MC-GZBM U1111-1297-5097 2023-503659-88-00 2023-508630-34-00
Conditions	Obesity\|Cardiovascular Diseases
Interventions	DRUG: Retatrutide\|DRUG: Placebo
Sponsor	Eli Lilly and Company
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	1800
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)\|Primary Purpose: TREATMENT
Start Date	30/05/2023
Completion Date	07/11/2028
Locations	Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Dipartimento Assistenziale Integrato Medico, Prof. Silvio Buscemi
Study URL	https://clinicaltrials.gov/study/NCT05882045

Title	Efficacy of a Wheat-free Diet in Autoimmune Diseases: a Pilot Therapeutic Study in Sjogren's Disease
NCT Number	NCT05644795
Conditions	Sjogren's Syndrome Non-celiac Gluten Sensitivity
Interventions	Dietary Supplement: Wheat/milk free diet (W/MFD) group Dietary Supplement: Rice/turkey free diet (R/TFD) group
Sponsor	Pasquale Mansueto, University of Palermo
Gender	All
Age	18 Years to 65 Years (Adult, Older Adult)
Phases
Enrollment	30
Study Type	Interventional (Clinical Trial)
Study Designs	Parallel Assignment
Start Date	01/01/2023
Completion Date	30/01/2026
Locations	A.O.U. Policlinico P. Giaccone di Palermo, Pasquale Mansueto, University of Palermo (Responsible Party)
URL	https://www.clinicaltrials.gov/ct2/show/NCT05644795

Study Title	Observational Study on Long-term Use of Pegunigalsidase Alfa in Fabry Patients in a Real-world Setting
NCT Number	NCT07109375 Other IDs: CHIT-2401
Conditions	Fabry Disease
Interventions	DRUG: pegunigalsidase alfa
Sponsor/Collaborators	Chiesi Italia
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases
Enrollment	75
Study Type	OBSERVATIONAL
Study Design	Observational Model: \|Time Perspective: p
Start Date	01/01/2026
Completion Date	01/11/2028
Locations	Prof. Antonino Tuttolomondo, , U.O.C. Medicina Interna con Stroke Care, Policlinico P. Giaccone, Palermo, Sicilia/Palermo, 90127, Italy \| AOU Federico II, Dipartimento di Nefrologia, Napoli, Italy
Study URL	https://clinicaltrials.gov/study/NCT07109375

Title	Efficacy and Safety of Luspatercept for the Treatment of Anemia Due to Myelodysplastic Syndromes With del5q, Refractory/Resistant/Intolerant to Prior Treatments, Who Require Red Blood Cell Transfusions
NCT Number	NCT05924100
Conditions	Myelodysplastic Syndromes Del(5Q) Anemia Transfusion-dependent Anemia
Interventions	Drug: Luspatercept Injection [Reblozyl]
Sponsor	Associazione Qol-one
Gender	All
Age	18 Years and older (Adult, Older Adult)
Phases	Phase 2
Enrollment	22 participants
Study Type	Interventional (Clinical Trial)
Study Designs	Single Group Assignment
Start Date	03/11/2022
Completion Date	03/11/2028
Locations	A.O.U. Policlinico P. Giaccone di Palermo, prof. Sergio Siragusa
URL	https://www.clinicaltrials.gov/ct2/show/NCT05924100

Study Title	Achievement of LLDAS5 in Patients With Systemic Lupus Erythematosus Treated With Anifrolumab
NCT Number	NCT07330245 Other IDs: D3461R00093
Study Status	RECRUITING
Conditions	Lupus Erythematosus, Systemic
Interventions	BIOLOGICAL: Anifrolumab
Sponsor/Collaborators	AstraZeneca
Sex	ALL
Age	CHILD, ADULT, OLDER_ADULT
Phases
Enrollment	218
Study Type	OBSERVATIONAL
Study Design	Observational Model: \|Time Perspective: p
Start Date	31/12/2025
Completion Date	30/09/2028
Locations	Prof.ssa Giuliana Guggino, UOC di Reumatologia, Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone", Palermo, 90127, Italy
Study URL	https://clinicaltrials.gov/study/NCT07330245

Title	LOWER: Lomitapide Observational Worldwide Evaluation Registry
NCT Number	NCT02135705 AEGR-733-025
Conditions	Homozygous Familial Hypercholesterolemia
Interventions	Parallel Assignment
Sponsor	Amryt Pharma
Gender	All
Age	Child, Adult, Older Adult
Phases
Enrollment	300
Study Type	Observational [Patient Registry]
Study Designs	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment
Start Date	18/03/2014
Completion Date	01/09/2028
Locations	A.O.U. Policlinico P. Giaccone di Palermo, Prof. Angelo Baldassare Cefalù, Principal Investigator
URL	https://clinicaltrials.gov/ct2/show/NCT02135705

Study Title	Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia (SHASTA-10)
NCT Number	NCT06822790 Other IDs AROAPOC3-3006 \| SHASTA-10
Conditions	Hypertriglyceridemia
Interventions	DRUG: Plozasiran Injection
Sponsor	Arrowhead Pharmaceuticals
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	840
Study Type	INTERVENTIONAL
Study Design	Allocation: NA\|Intervention Model: SINGLE_GROUP\|Masking: NONE\|Primary Purpose: TREATMENT
Start Date	09/04/2025
Completion Date	01/07/2028
Locations	Palermo, Sicilia, Italy, 90129, A.O.U. Policlinico Paolo Giaccone ( Site 1815) Contact : Prof. Angelo Baldassare Cefalù
Study URL	https://clinicaltrials.gov/study/NCT06822790

Title	Efficacy and Safety of Luspatercept for the Treatment of Anemia Due to Myelodysplastic Syndromes with del5q refractory/resistant/intolerant to Prior Treatments, Who Require Red Blood Cell Transfusion. Efficacia e Sicurezza del Luspatercept per il Trattamento dell’Anemia dovuta alle Sindromi Mielodisplastiche con del5q refrattarie/resistenti/intolleranti a precedenti Trattamenti e che richiedono Trasfusioni di Globuli Rossi.
EudraCT number	2021-001538-20
Medical condition	Anemia due to MDS with del5q with IPSS-R very low, low, or intermediate risk MDS and a bone marrow blast count of < 5% , Refractory or intolerant to, or ineligible for, prior ESA treatment and for prior lenalidomide treatment and who require RBC transfusions. Anemia dovuta a MDS con del5q con IPSS-R MDS a rischio molto basso, basso o intermedio e una conta dei blasti del midollo osseo < 5% , refrattari o intolleranti o non idonei ad un precedente trattamento con agenti stimolanti eritropoietici (ESA) e ad un precedente trattamento con Lenalidomide e che richiedono trasfusioni di RBC
Interventions
Sponsor/Collaborators	ASSOCIAZIONE QOL-ONE
Gender	Female; Male
Age	Adults; Elderly;
Phases	Phase II
Enrollment	22
Study Type	Therapeutic exploratory (Phase II)
Study Design
Start Date	07/04/2022
Completion Date	05/04/2028
Locations	Italy - A.O.U. Policlinico P. Giaccone Palermo, SIRAGUSA SERGIO
URL	https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-001538-20/IT

Title	An Open-Label Extension Study of AKCEA-APOCIII-LRx Administered Subcutaneously to Patients With Familial Chylomicronemia Syndrome (FCS)
NCT Number	NCT05130450 - (EudraCT Number: 2021-003280-95)
Conditions	Familial Chylomicronemia Syndrome
Interventions	Drug: Olezarsen
Sponsor	Ionis Pharmaceuticals, Inc.
Gender	All
Age	18 Years and older (Adult, Older Adult)
Phases	Phase 3
Enrollment	60
Study Type	Interventional
Study Designs	Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Start Date	18/11/2021
Completion Date	29/02/2028
Locations	Italy UOC di Farmacia AOUP PAOLO GIACCONE - Palermo, Italy, 90127 Prof. Angelo Baldassare Cefalù, Principal Investigator and other 11 international study locations
URL	https://ClinicalTrials.gov/show/NCT04568434

Study Title	A Non-Interventional Clinical Study to Evaluate Long-Term Safety and Effectiveness of HUMIRA (Adalimumab) in Pediatric Patients With Moderately to Severely Active Crohn's Disease (CD)
NCT Number	NCT02130362 Other IDs: P11-292
Conditions	Crohn's Disease
Interventions
Sponsor	AbbVie
Gender	ALL
Age	CHILD
Phases
Enrollment	1446
Study Type	OBSERVATIONAL
Study Design	Observational Model: \|Time Perspective: p
Start Date	28/08/2014
Completion Date	03/02/2028
Locations	U.O. Gastroenterologia - Malattie Infiammatorie Croniche Intestinali, Prof. Calogero Cammà, Policlinico Paolo Giaccone /ID# 138410, Palermo, Sicilia, 90127, Italy\| A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 152684, Palermo, 90146, Italy\|
Study URL	https://clinicaltrials.gov/study/NCT02130362

Study Title	A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
NCT Number	NCT06686615 DSE-BMP-01-24-EU
Conditions	Primary Hypercholesterolemiia\|Mixed Dyslipidemia
Interventions	DRUG: Bempedoic acid\|DRUG: Ezetimibe\|DRUG: Rosuvastatin\|DRUG: Atorvastatin
Sponsor	Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases
Enrollment	2000
Study Type	OBSERVATIONAL
Study Design	Observational Model: \|Time Perspective: p
Start Date	12/02/2025
Completion Date	31/01/2028
Locations	Prof. Angelo Baldassare Cefalù, A.O.U. Policlinico P. Giaccone Palermo, UOC di Astanteria MCAU \| Policlinico Umberto I, Rome, 00161, Italy
Study URL	https://clinicaltrials.gov/study/NCT06686615

Study Title	Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
NCT Number	NCT04526665 Other IDs: GFT505B-319-1\|2019-004941-34
Conditions	Primary Biliary Cirrhosis
Interventions	DRUG: Elafibranor 80mg\|DRUG: Placebo
Sponsor	Ipsen
Gender	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	161
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date	24/09/2020
Completion Date	12/01/2028
Locations	Azienda Ospedaliera Universitaria Policlinico P. Giaccone, UOC di Gastroenterologia - Dip.Medicina Interna e Specialistica, Palermo, 90127, Italy
Study URL	https://clinicaltrials.gov/study/NCT04526665

Study Title	Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia
NCT Number	NCT02735707 Other IDs: U1111-1189-1653\|2015-002340-14\|602525\|16/631\|APP1101719\|158584\|2023-507889-89-00\|965313
Conditions	Community-acquired Pneumonia, Influenza, COVID-19
Interventions	DRUG: Ceftriaxone\|DRUG: Moxifloxacin or Levofloxacin\|DRUG: Piperacillin-tazobactam\|DRUG: Ceftaroline\|DRUG: Amoxicillin-clavulanate\|DRUG: Standard course macrolide\|DRUG: Extended course macrolide\|OTHER: No systemic corticosteroid\|DRUG: Fixed-duration Hydrocortisone\|DRUG: Shock-dependent hydrocortisone\|DRUG: Fixed-duration higher dose Hydrocortisone\|OTHER: No antiviral agent for influenza\|DRUG: Five-days oseltamivir\|DRUG: Ten-days oseltamivir\|OTHER: No antiviral agent for COVID-19\|DRUG: Lopinavir / Ritonavir\|DRUG: Hydroxychloroquine\|DRUG: Hydroxychloroquine + lopinavir/ritonavir\|DRUG: Ivermectin\|OTHER: No immune modulation for COVID-19\|DRUG: Interferon beta-1a\|DRUG: Anakinra\|DRUG: Tocilizumab\|DRUG: Sarilumab\|DRUG: Local standard venous thromboprophylaxis\|DRUG: Therapeutic dose anticoagulation\|DRUG: Conventional low dose thromboprophylaxis\|DRUG: Intermediate dose thromboprophylaxis\|DRUG: Continuation of therapeutic dose anticoagulation\|OTHER: No immunoglobulin\|BIOLOGICAL: Convalescent plasma\|BIOLOGICAL: Delayed administration of convalescent plasma\|OTHER: No vitamin C\|DRUG: Vitamin C\|OTHER: No antiplatelet\|DRUG: Aspirin\|DRUG: P2Y12 inhibitor\|OTHER: No simvastatin\|DRUG: Simvastatin\|DRUG: Eritoran\|DRUG: Apremilast\|PROCEDURE: Clinician-preferred mechanical ventilation strategy\|PROCEDURE: Protocolised mechanical ventilation strategy\|OTHER: No renin-angiotensin system inhibitor\|DRUG: Angiotensin converting enzyme inhibitor\|DRUG: Angiotensin Receptor Blockers\|DRUG: ARB + DMX-200\|OTHER: No cysteamine\|DRUG: Cysteamine\|DRUG: Fixed-duration dexamethasone\|DRUG: Baloxavir Marboxil\|DRUG: Five-days oseltamivir + baloxavir marboxil\|DRUG: Ten-days oseltamivir + baloxavir marboxil\|OTHER: No endothelial modulator\|DRUG: Imatinib\|OTHER: No Immune Modulator for Influenza\|DRUG: Tocilizumab\|DRUG: Baricitinib\|OTHER: No antiviral agent for COVID-19\|DRUG: Nirmatrelvir/ritonavir\|DRUG: Remdesivir\|DRUG: Nirmatrelvir/ritonavir + remdesivir
Sponsor	Sponsor: UMC Utrecht Collaborators: Australian and New Zealand Intensive Care Research Centre\|Medical Research Institute of New Zealand\|Unity Health\|Berry Consultants\|Global Coalition for Adaptive Research\|University of Pittsburgh Medical Center\|Intensive Care National Audit & Research Centre\|St. Marianna University School of Medicine\|Nat Intensive Care Surveillance - MORU\|National University Hospital, Singapore
Gender	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	20000
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: FACTORIAL\|Masking: NONE\|Primary Purpose: TREATMENT
Start Date	04/11/2016
Completion Date	02/01/2028
Locations	Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo, 90127, Italy
Study URL	https://clinicaltrials.gov/study/NCT02735707

Study Title	A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis
NCT Number	NCT03900429
Conditions	NASH - Nonalcoholic Steatohepatitis
Interventions	DRUG: MGL-3196\|DRUG: Placebo
Sponsor	Madrigal Pharmaceuticals, Inc.
Gender
Age
Phases	PHASE3
Enrollment	1759
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date	28/03/2019
Completion Date	01/01/2028
Locations	Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone, Palermo, Italy\| Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT), Palermo, Italy\|
URL	https://clinicaltrials.gov/study/NCT03900429

Study Title	MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)
NCT Number	NCT06152575 Other Ids C1071032\|MAGNETISMM-32\|2023-507871-23-00
Conditions	Multiple Myeloma
Interventions	DRUG: Elranatamab\|DRUG: Elotuzumab\|DRUG: Pomalidomide\|DRUG: Dexamethasone\|DRUG: Bortezomib\|DRUG: Carfilzomib
Sponsor	Pfizer
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	492
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: NONE\|Primary Purpose: TREATMENT
Start Date	08/02/2024
Completion Date	30/12/2027
Locations	U.O.C. di Ematologia, A.O.U. Policlinico Paolo Giaccone, Palermo, Sicily, 90127, Italy, Prof. Cirino Botta IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Emilia-Romagna, 47014, Italy\|P.O. San Carlo Borromeo- ASST SANTI PAOLO E CARLO, Milan, Lombardy, 20153, Italy\|Azienda Socio Sanitaria Ovest milanese, Legnano, Milano, 20025, Italy\|Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Piedmont, 10126, Italy\| \| Azienda Ospedaliero Universitaria delle Marche, Ancona, The Marches, 60126, Italy\|Azienda Ospedaliera Universitaria Careggi, Florence, Tuscany, 50134, Italy\|Azienda Ospedaliero Universitaria Pisana, Pisa, Tuscany, 56126, Italy\|IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola, Bologna, 40138, Italy\|Istituto Europeo di Oncologia IRCCS, Milan, 20141, Italy\|Ospedale Civile dello Spirito Santo, Pescara, 65124, Italy
Study URL	https://clinicaltrials.gov/study/NCT06152575

Title	A Double-blind Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients with Primary Biliary Cholangitis with Inadequate Response or Intolerance to Ursodeoxycholic Acid Studio in doppio cieco, randomizzato e controllato con placebo con estensione a lungo termine in aperto volto a valutare l'efficacia e la sicurezza di elafibranor 80 mg in pazienti affetti da colangite biliare primitiva con risposta inadeguata o intolleranza all'acido ursodesossicolico
EudraCT number	2019-004941-34
Medical condition	Primary Biliary Cholangitis colangite biliare primitiva
Interventions
Sponsor/Collaborators	GENFIT
Gender	Female; Male
Population Age	Adults; Elderly;
Phases	Phase III
Enrollment	150
Trial type	Therapeutic confirmatory (Phase III)
Design of the trial	Controlled; Randomised;
Start Date	03/05/2021
Completion Date	28/12/2027
Locations	prof.ssa Calvaruso Vincenza, A.O.U. Policlinico P. Giaccone Palermo
URL	https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-004941-34/IT

Study Title	Evaluation of the Effects of a Nutritional Intervention of Ketogenic Medium-chain Triglycerides and B-vitamins on Cognitive Functioning in Older Adults With Mild Cognitive Impairment (COGNIKET-MCI)
NCT Number	NCT06347315 Other IDs: 2302.CLI
Conditions	Mild Cognitive Impairment
Interventions	DIETARY_SUPPLEMENT: BrainXpert\|OTHER: Placebo
Sponsor	Société des Produits Nestlé (SPN)
Gender	ALL
Age	ADULT, OLDER_ADULT
Phases	NA
Enrollment	380
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)\|Primary Purpose: OTHER
Start Date	24/05/2024
Completion Date	15/12/2027
Locations	Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone", Palermo, Italy\|
Study URL	https://clinicaltrials.gov/study/NCT06347315

Title	Assessment of Guselkumab (Tremfya) and IL-17 Inhibitor Therapies in Patients With Psoriatic Arthritis in Routine Clinical Practice; A Prospective, Observational Cohort Study
NCT Number	NCT05049798
Conditions	Arthritis, Psoriatic
Interventions	Drug: Guselkumab Drug: IL-17i
Sponsor	Janssen Pharmaceutica N.V., Belgium
Gender	All
Age	18 Years and older (Adult, Older Adult)
Phases
Enrollment	1300 participants
Study Type	Observational
Study Designs	Cohort
Start Date	25/08/2021
Completion Date	07/12/2027
Locations	A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. Dermatologia, Prof.^ssa Maria Rita Bongiorno
URL	https://www.clinicaltrials.gov/ct2/show/NCT05049798

Title	A Phase 3, Randomized, Double-blind, Active-Control Study of CPI-0610 and Ruxolitinib vs. Placebo and Ruxolitinib in JAKi Treatment Naive MF Patients Studio di fase 3, randomizzato, in doppio cieco, con controllo attivo di CPI-0610 e Ruxolitinib rispetto a placebo e Ruxolitinib nei pazienti con MF naïve al trattamento con JAKi
EudraCT number	2020-001989-10 MANIFEST-2 CPI 0610-04 NCT04603495
Conditions	Myelofibrosis Mielofibrosi
Interventions
Sponsor Name	Constellation Pharmaceuticals, Inc.
Gender	Female; Male
Age	Adults; Elderly;
Phases	Phase III
Enrollment	310
Study Type	Therapeutic confirmatory (Phase III)
Study Designs	Controlled; Randomised; Parallel group; Il crossover è possibile per il braccio di controllo dopo il trattamento in doppio cieco Crossover is possible for control arm after double-blind treatment
Start Date	02/11/2021
Completion Date	01/12/2027
Locations	United States - A.O.U. Policlinico P. Giaccone Palermo, U.O.C. di Ematologia, Dott. Marco Santoro
URL	https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001989-10/IT

Title	The cardiovascular safety of cagrilintide 2.4 mg s.c. in combination with semaglutide 2.4 mg s.c. (CagriSema 2.4 mg/2.4 mg s.c.) once-weekly in participants with obesity and established cardiovascular disease Sicurezza cardiovascolare di cagrilintide 2,4 mg in combinazione con semaglutide 2,4 mg (CagriSema 2,4 mg/2,4 mg) da assumere per via sottocutanea una volta alla settimana in partecipanti con obesità e malattia cardiovascolare accertata
EudraCT number	2021-005855-35 NN9838-4942
Conditions	Atherosclerotic cardiovascular disease and Obesity Malattia cardiovascolare aterosclerotica e obesità
Interventions
Sponsor	NOVO NORDISK. S.P.A.
Gender	Female; Male
Age	Adults; Elderly;
Phases	Phase III
Enrollment	4000
Study Type	Therapeutic confirmatory (Phase III)
Study Designs	Controlled; Randomised; Parallel group;
Start Date	01/10/2023
Completion Date	29/11/2027
Locations	Italy - A.O.U. Policlinico P. Giaccone Palermo, Prof. Silvio Buscemi;
URL	https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-005855-35/IT

Title	A Randomized, Open-Label, Parallel-Group, Two-Arm, Phase 4 Study to Evaluate the Long-Term Efficacy and Safety of Tirzepatide Compared With Intensified Conventional Care in Adults When Initiating Treatment Early in the Course of Type 2 Diabetes
NCT Number	NCT05433584 17205 I8F-MC-GPHE ( Other Identifier ) (OTHER: Eli Lilly and Company) 2022-000130-42 ( EudraCT Number ) 2022-5010733-40-00 ( Other Identifier ) (OTHER: EU Trial Number) U1111-1282-0263 ( Registry Identifier ) (REGISTRY: World Health Organization)
Conditions	Type 2 Diabetes
Interventions	Drug: Tirzepatide Drug: Antihyperglycemic medication
Sponsor	Eli Lilly and Company
Gender	All
Age	18 Years and older (Adult, Older Adult)
Phases	Phase 4
Enrollment	780 participants
Study Type	Interventional (Clinical Trial)
Study Designs	Parallel Assignment
Start Date	01/08/2022
Completion Date	29/11/2027
Locations	A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. Malattie Endocrine, del Ricambio e della Nutrizione, prof.^ssa Carla Giordano
URL	https://www.clinicaltrials.gov/ct2/show/NCT05433584

Study Title	Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma
NCT Number	NCT06676319 Other IDs: ACT18301\|2024-513959-33
Conditions	Asthma
Interventions	DRUG: Lunsekimig\|DRUG: Short-Acting Beta Agonists (SABA)\|DRUG: Placebo\|DRUG: Fluticasone/salmeterol\|DRUG: Budesonide/formoterol
Sponsor	Sanofi
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE2
Enrollment	1000
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date	07/11/2024
Completion Date	12/11/2027
Locations	Nicola Scichilone, U.O. Pneumologia, Policlinico "Paolo Giaccone", Palermo, 90127, Italy
Study URL	https://clinicaltrials.gov/study/NCT06676319

Study Title	REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels
NCT Number	NCT05669755 Other IDs: NN9838-4942\|U1111-1270-0943\|2021-005855-35\|jRCT2031220672
Conditions	Cardiovascular Disease
Interventions	DRUG: Cagrilintide\|DRUG: Semaglutide\|DRUG: Placebo
Sponsor	Novo Nordisk A/S
Gender	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	7000
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date	03/01/2023
Completion Date	13/10/2027
Locations	prof. Silvio Buscemi, Unità funzionale di Nutrizione Clinica, Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone", Palermo, 90127, Italy\|
Study URL	https://clinicaltrials.gov/study/NCT05669755

Title	A Phase 3, Randomized, Double-blind, Placebo-Controlled Study to Investigate the Effect of Tirzepatide on the Reduction of Morbidity and Mortality in Adults With Obesity
NCT Number	NCT05556512
Conditions	Obesity Overweight
Interventions	Drug: Tirzepatide Drug: Placebo
Sponsor	Eli Lilly and Company
Gender	All
Age	40 Years and older (Adult, Older Adult)
Phases	Phase 3
Enrollment	15000 participants
Study Type	Interventional (Clinical Trial)
Study Designs	Parallel Assignment
Start Date	11/10/2022
Completion Date	07/10/2027
Locations	A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. Nutrizione Clinica, Obesità e Metabolismo, prof. Silvio Buscemi
URL	https://www.clinicaltrials.gov/ct2/show/NCT05556512

Study Title	A Study of Guselkumab in Participants With Active Psoriatic Arthritis
NCT Number	NCT04882098
Conditions	Arthritis, Psoriatic
Interventions	DRUG: Guselkumab\|DRUG: Placebo
Sponsor	Janssen Research & Development, LLC
Gender
Age
Phases	PHASE3
Enrollment	950
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)\|Primary Purpose: TREATMENT
Start Date	17/06/2021
Completion Date	12/08/2027
Locations	Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone, Palermo, 90127, Italy\|
URL	https://clinicaltrials.gov/study/NCT04882098

Title	Obicetrapib and Cardiovascular Outcomes: A Placebo-Controlled, Double- Blind, Randomized Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With Atherosclerotic Cardiovascular Disease (ASCVD) Who are Not Adequately Controlled Despite Maximally Tolerated Lipid-Modifying Therapies Obicetrapib ed esiti cardiovascolari: Studio di fase 3 randomizzato, in doppio cieco, controllato con placebo per valutare l’effetto di 10 mg di Obicetrapib in partecipanti affetti da malattia cardiovascolare aterosclerotica (ASCVD) non adeguatamente controllati nonostante le terapie modificanti i lipidi alla dose massima tollerata
EudraCT number	2021-005092-39 TA8995-304
Medical condition	Atherosclerotic cardiovascular disease (ASCVD) Malattia cardiovascolare aterosclerotica (ASCVD)
Interventions
Sponsor/Collaborators	NewAmsterdam Pharma B.V.
Gender	Female; Male
Population Age	Adults; Elderly;
Phases	Phase III
Enrollment	9000
Trial type	Therapeutic confirmatory (Phase III)
Design of the trial	Controlled; Randomised;
Start Date	04/12/2022
Completion Date	31/07/2027
Locations	A.O.U. Policlinico P. Giaccone Palermo, UOC di Astanteria MCAU, Prof. Angelo Baldassare Cefalù
URL	https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-005092-39/IT

Study Title	Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide
NCT Number	NCT07220642 Other IDs: NN9833-8242\|U1111-1314-8906\|2024-519530-24
Conditions	Obesity\|Overweight
Interventions	DRUG: Cagrilintide\|DRUG: Placebo
Sponsor/Collaborators	Novo Nordisk A/S
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	300
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date	05/11/2025
Completion Date	14/07/2027
Locations	Prof. Silvio Buscemi, AOUP Giaccone Palermo, Palermo, Sicily, 90127, Italy
Study URL	https://clinicaltrials.gov/study/NCT07220642

Study Title	A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis
NCT Number	NCT05050136 Other Ids: VLX-601; EUCT: 2021-00138939
Conditions	Primary Biliary Cholangitis\|PBC
Interventions	DRUG: Volixibat\|DRUG: Placebo
Sponsor/Collaborators	Mirum Pharmaceuticals, Inc.
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE2
Enrollment	260
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)\|Primary Purpose: TREATMENT
Start Date	22/09/2021
Completion Date	01/07/2027
Locations	Prof.ssa Vincenza Calvaruso, A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. Gastroenterologia
Study URL	https://clinicaltrials.gov/study/NCT05050136

Study Title	A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
NCT Number	NCT05878769 GB43374
Conditions	Chronic Obstructive Pulmonary Disease
Interventions	DRUG: Astegolimab
Sponsor/Collaborators	Hoffmann-La Roche Società PPD Global Ltd., per la conduzione della sperimentazione clinica su medicinali
Gender	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	2000
Study Type	INTERVENTIONAL
Study Design	Allocation: NA\|Intervention Model: SINGLE_GROUP\|Masking: NONE\|Primary Purpose: TREATMENT
Start Date	28/06/2023
Completion Date	30/06/2027
Locations	Azienda Ospedaliero Universitaria Policlinico P. Giaccone, Palermo, UOC di Pneumologia, Prof. Nicola Scichilone
Study URL	https://clinicaltrials.gov/study/NCT05878769

Title	17 beta-Hydroxysteroid Dehydrogenase type 13 Minimization for the treatment of NASH (HORIZON): A Double-Blind, Placebo-Controlled Phase 2b Study to Evaluate the Efficacy and Safety of GSK4532990 in Adults with Pre-Cirrhotic Non-Alcoholic Steatohepatitis Studio in doppio cieco, controllato verso placebo, di Fase 2b per valutare l’efficacia e la sicurezza di GSK4532990 in adulti con steatoepatite pre-cirrotica non alcolica (Non-Alcoholic Steatohepatitis – NASH)
EudraCT number	2022-002538-14 - 2023-507503-62-00 - NCT05583344 - 218672
Conditions	Nonalcoholic steatohepatitis (NASH) Steatoepatite pre-cirrotica non alcolica (NASH)
Interventions	Drug: GSK4532990 Drug: Placebo
Sponsor/Collaborators	GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT
Gender	Female; Male
Age	Adults; Elderly;
Phases	Phase II
Enrollment	246
Study Type	Therapeutic exploratory (Phase II)
Study Design	Controlled; Randomised; Parallel group;
Start Date	27/01/2023
Completion Date	05/04/2027
Locations	A.O.U. Policlinico P. Giaccone Palermo, Prof. Salvatore Petta, U.O.C. di Gastroenterologia
URL	https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-002538-14/IT

Title	Phase 3 Study to Assess Gemtuzumab, in Combination With Standard Chemotherapy, on MRD Levels, and the Role of Glasdegib as a Post-transplant Maintenance, in Adult, 18-60 Years, With Previously Untreated de Novo Fav-interm Risk AML
NCT Number	NCT04168502 AML1819 2019-003871-20
Conditions	Favorable-intermediate-risk Acute Myeloid Leukemia (AML) Leucemia Mieloide Acuta (LMA) a rischio favorevole o intermedio
Interventions	Parallel Assignment
Sponsor	Fondazione GIMEMA; Pfizer S.R.L.
Gender	All
Age	18 Years to 60 Years (Adult)
Phases	III
Enrollment	414 participants
Study Type	Interventional (Clinical Trial)
Study Designs	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Start Date	24/09/2020
Completion Date	01/04/2027
Locations	A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa, Dott.^ssa Mitra
URL	https://clinicaltrials.gov/ct2/show/NCT04168502

Study Title	Clairleafᵀᴹ: A Study to Test Long-term Treatment With BI 1291583 in People With Bronchiectasis Who Took Part in a Previous Study With This Medicine
NCT Number	NCT05846230 Other IDs: 1397-0017\|2023-503290-38-00\|U1111-1292-0921
Conditions	Bronchiectasis
Interventions	DRUG: BI 1291583\|DRUG: Placebo matching BI 1291583
Sponsor	Boehringer Ingelheim
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE2
Enrollment	269
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date	09/08/2023
Completion Date	31/03/2027
Locations	Salvatore Battaglia, Nicola Scichilone, U.O. Pneumologia, Policlinico "Paolo Giaccone", Palermo, 90127, Italy\|
Study URL	https://clinicaltrials.gov/study/NCT05846230

Study Title	A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
NCT Number	NCT05595642 Other IDs: GB44332
Conditions	Chronic Obstructive Pulmonary Disease (COPD)
Interventions	DRUG: Astegolimab\|DRUG: Placebo
Sponsor	Hoffmann-La Roche
Gender	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	1290
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)\|Primary Purpose: TREATMENT
Start Date	29/12/2022
Completion Date	11/03/2027
Locations	prof. Nicola Scichilone, U.O.C. di Pneumologia, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo, Sicilia, 90127, Italy\|
Study URL	https://clinicaltrials.gov/study/NCT05595642

Study Title	Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery
NCT Number	NCT05936580 Other IDs: GENA-23
Conditions	Hemophilia A
Interventions	DRUG: Nuwiq
Sponsor	Octapharma
Gender	FEMALE
Age	CHILD, ADULT, OLDER_ADULT
Phases	PHASE4
Enrollment	28
Study Type	INTERVENTIONAL
Study Design	Allocation: NA\|Intervention Model: SINGLE_GROUP\|Masking: NONE\|Primary Purpose: TREATMENT
Start Date	01/04/2024
Completion Date	28/02/2027
Locations	Policlinico "P. Giaccone", Palermo, Italy\|
Study URL	https://clinicaltrials.gov/study/NCT05936580

Title	TRANSFORM: A 52-week, Randomized, Placebo-controlled, Double-blind, Adaptive Phase 2b/3 Trial of Setanaxib With a 52-week Extension Phase in Patients With Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness
NCT Number	NCT05014672 GSN000350 2021-001810-13 ( EudraCT Number )
Conditions	Primary Biliary Cholangitis Liver Stiffness
Interventions	Parallel Assignment
Sponsor	Calliditas Therapeutics Suisse SA Promotore: Genkyotex Suisse SA CRO: Pharmaceutical Research Associates Italy S.r.l.
Gender	All
Age	18 Years and older (Adult, Older Adult)
Phases	Phase 2 Phase 3
Enrollment	318 participants
Study Type	Interventional (Clinical Trial)
Study Designs	Allocation: Randomized \| Intervention Model: Parallel Assignment \| Intervention Model Description: Placebo-controlled 1:1:1 in double blind treatment period with 1:1 reassignment to setanaxib in extension period \| Masking: Double (Participant, Investigato
Start Date	14/02/2022
Completion Date	09/01/2027
Locations	Sperimentatore: Dott.^ssa V. Calvaruso Centro: U.O.C. di Gastroenterologia
URL	https://clinicaltrials.gov/ct2/show/NCT05014672

Title	The Role of Gut-skin Axis in Psoriasis: a Randomized Placebo-controlled Dietary Approach to Assess Clinical Efficacy in Mild-to-moderate Psoriasis
NCT Number	NCT05644782 - ACPM30
Conditions	Psoriasis Gluten Sensitivity
Interventions	Other: Open wheat challenge Other: Placebo challenge
Sponsor	Pasquale Mansueto, University of Palermo
Gender	All
Age	18 Years to 65 Years (Adult, Older Adult)
Phases
Enrollment	82 participants
Study Type	Interventional (Clinical Trial)
Study Designs	Parallel Assignment
Start Date	01/01/2023
Completion Date	01/01/2027
Locations	A.O.U. Policlinico P. Giaccone di Palermo, prof. Pasquale Mansueto, prof.^ssa Maria Rita Bongiorno, prof. Antonio Carroccio
URL	https://www.clinicaltrials.gov/ct2/show/NCT05644782

Title	Potential Role of Sodium Glucose Cotransporter 2 Inhibitors in the Treatment of Ascites in Cirrhotic Patients
NCT Number	NCT05999773
Conditions	Intervention/treatment Ascites Hepatic Cirrhosis, Liver Diabete Type 2
Interventions	Drug: SGLT2 inhibitor
Sponsor
Gender	All
Age	18 Years to 80 Years (Adult, Older Adult)
Phases
Enrollment	40 participants
Study Type	Observational
Study Designs	Case-Control
Start Date	15/06/2023
Completion Date	31/12/2026
Locations	A.O.U. Policlinico P. Giaccone di Palermo, Lydia Giannitrapani, Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello, Aurelio Seidita
URL	https://www.clinicaltrials.gov/ct2/show/NCT05999773

Study Title	Observational Study on the Use of Ropeginterferon Alfa-2b in Polycythemia Vera (ROPEG-PV)
NCT Number	NCT06506084 Other IDs: ROPEG-PV
Conditions	Polycythemia Vera
Interventions	DRUG: Ropeginterferon alfa-2b
Sponsor	FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Gender	ALL
Age	ADULT, OLDER_ADULT
Phases
Enrollment	319
Study Type	OBSERVATIONAL
Study Design	Observational Model: \|Time Perspective: p
Start Date	09/08/2022
Completion Date	31/12/2026
Locations	Azienda Ospedaliera Universitaria Policlinico "P. Giaccone", Divisione di Ematologia, Palermo, Italy\|
Study URL	https://clinicaltrials.gov/study/NCT06506084

Title	Urinary Gluten Detection in Patients With Non-celiac Gluten/Wheat Sensitivity
NCT Number	NCT04219813 ACPM24
Conditions	Non-celiac Gluten/Wheat Sensitivity
Interventions	Other: Urinary test
Sponsor	Pasquale Mansueto, University of Palermo
Gender	All
Age	18 Years to 75 Years (Adult, Older Adult)
Phases
Enrollment	40 participants
Study Type	Interventional (Clinical Trial)
Study Designs	Single Group Assignment
Start Date	01/01/2021
Completion Date	31/12/2026
Locations	A.O.U. Policlinico P. Giaccone di Palermo, Pasquale Mansueto, University of Palermo (Responsible Party)
URL	https://www.clinicaltrials.gov/ct2/show/NCT04219813

Title	HoFH, the International Clinical Collaborators - A Global HoFH Data-sharing Platform
NCT Number	NCT04815005 - HICC
Conditions	Homozygous Familial Hypercholesterolemia
Interventions	Parallel Assignment
Sponsor	University of Pennsylvania
Gender	All
Age	Child, Adult, Older Adult
Phases
Enrollment	1000 participants
Study Type	Observational [Patient Registry]
Study Designs	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment
Start Date	24/01/2017
Completion Date	31/12/2026
Locations	A.O.U. Policlinico P. Giaccone di Palermo, Prof. Maurizio Averna, Prof. Angelo Baldassare Cefalù
URL	https://clinicaltrials.gov/ct2/show/NCT04815005 https://www.centerwatch.com/clinical-trials/listings/270143/hofh-the-international-clinical-collaborators-registry/

Study Title	Safety and Effectiveness of BMS-986263 in Adults With Compensated Cirrhosis (Liver Disease) From Nonalcoholic Steatohepatitis (NASH)
NCT Number	NCT04267393 IM025-017 2019-003932-22 U1111-1241-4762
Conditions	Nonalcoholic Steatohepatitis (NASH)
Interventions	DRUG: BMS-986263\|OTHER: Placebo
Sponsor	Bristol-Myers Squibb
Gender	All
Age	21 Years to 75 Years (Adult, Older Adult )
Phases	PHASE2
Enrollment	124
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date	17/03/2021
Completion Date	28/12/2026
Locations	A.O.U. Policlinico Paolo Giaccone-Dep. Of Internal Medicine and Specialistic, Palermo, 90127, Italy\|
URL	https://clinicaltrials.gov/study/NCT04267393

Title	A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Olpasiran on Major Cardiovascular Events in Participants With Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein(a)
NCT Number	NCT05581303 AMG 20180244
Conditions	Atherosclerotic Cardiovascular Disease
Interventions	Parallel Assignment
Sponsor	Amgen
Gender	All
Age	18 Years to 85 Years (Adult, Older Adult)
Phases	Phase 3
Enrollment	6000 participants
Study Type	Interventional (Clinical Trial)
Study Designs	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment
Start Date	14/12/2022
Completion Date	16/12/2026
Locations	A.O.U. Policlinico P. Giaccone di Palermo, Prof. Angelo Baldassare Cefalù, Principal Investigator
URL	https://clinicaltrials.gov/ct2/show/NCT05581303 https://www.amgentrials.com/study/?id=20180244

Title	Obicetrapib and Cardiovascular Outcomes: A Placebo-Controlled, Double- Blind, Randomized Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With Atherosclerotic Cardiovascular Disease (ASCVD) Who are Not Adequately Controlled Despite Maximally Tolerated Lipid-Modifying Therapies
NCT Number	2021-005092-39 (EudraCT)
Conditions	atherosclerotic cardiovascular disease (ASCVD)
Interventions
Sponsor	NewAmsterdam Pharma B.V.
Gender	All
Age	18 years of age at Screening (Visit 1)
Phases	Phase 3
Enrollment	9000 participants
Study Type	Therapeutic confirmatory (Phase III)
Study Designs	Controlled Randomised Double blind
Start Date	12/04/2022
Completion Date	07/12/2026
Locations	A.O.U. Policlinico P. Giaccone di Palermo, Prof. Angelo Baldassare Cefalù, Principal Investigator
URL	https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-005092-39/IT

Study Title	IRI-EXPLORE: A Study to Test Whether BI 765845 Helps People Who Have Had a Heart Attack
NCT Number	NCT06139328 Other Ids: 1478-0002\|U1111-1291-6320\|2022-502788-39-00
Conditions	Myocardial Infarction
Interventions	DRUG: BI 765845\|DRUG: Placebo matching BI 765845
Sponsor	Boehringer Ingelheim
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE2
Enrollment	160
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)\|Primary Purpose: TREATMENT
Start Date	05/12/2023
Completion Date	03/12/2026
Locations	Prof. Alfredo Ruggero Galassi, AOU Giaccone, Palermo, Italy Ospedale San Paolo-Bari-18924, Bari, 70124, Italy\|Azienda Ospedaliera Cannizzaro, Catania, 95126, Italy\|Azienda Ospedaliera Universitaria Arcispedale Sant'Anna, Cona (FE), 44124, Italy\|Osp. Pediatrico Apuano Pasquinucci, Massa, 54100, Italy\|A.O. San Gerardo di Monza, Monza, 20900, Italy\|Ospedale Mauriziano di Torino, Torino, 10128, Italy
Study URL	https://clinicaltrials.gov/study/NCT06139328

Study Title	Inflammatory Back Pain and Gluten Free Diet
NCT Number	NCT03017716 Other IDs ACPM14
Conditions	Inflammatory Back Pain
Interventions	OTHER: Gluten free diet
Sponsor/Collaborators	University of Palermo
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases	NA
Enrollment	50
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: NONE\|Primary Purpose: TREATMENT
Start Date	01/07/2025
Completion Date	01/12/2026
Locations	Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca, Sciacca, Agrigento, 92019, Italy prof. Antonio Carroccio, prof. Pasquale Mansueto, Department of Internal Medicine, University Hospital of Palermo, Palermo, 90129, Italy
Study URL	https://clinicaltrials.gov/study/NCT03017716

Study Title	Response to Different Wheat Genotypes in Not-celiac Wheat Sensitivity
NCT Number	NCT03024775 - Other Ids ACPM16
Conditions	Non-celiac Wheat Sensitivity
Interventions	DIETARY_SUPPLEMENT: Wheat flour\|DIETARY_SUPPLEMENT: Placebo
Sponsor	University of Palermo
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases	NA
Enrollment	50
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: CROSSOVER\|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: OTHER
Start Date	01/01/2017
Completion Date	01/12/2024
Locations	Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca, Sciacca, Agrigento, 92019, Italy prof. Antonio Carroccio, prof. Pasquale Mansueto, Department of Internal Medicine, University Hospital of Palermo, Palermo, 90129, Italy
Study URL	https://clinicaltrials.gov/study/NCT03024775

Title	Not-celiac Wheat Sensitivity (NCWS) in Patients With Irritable Bowel Syndrome. Randomized Double-Blind Placebo-Controlled Trial (Wheat vs Placebo) for Bio-markers Identification of NCWS and Understanding Its Pathogenetic Mechanisms.
NCT Number	NCT01762579
Conditions	Not-celiac Wheat Sensitivity
Interventions	Parallel Assignment Dietary Supplement: wheat flour Dietary Supplement: Xylose
Sponsor	Pasquale Mansueto, University of Palermo
Gender	All
Age	18 Years to 65 Years (Adult, Older Adult)
Phases
Enrollment	100 participants
Study Type	Interventional (Clinical Trial)
Study Designs	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Diagnostic
Start Date	01/01/2012
Completion Date [*]	01/12/2026
Locations	Internal Medicine, University Hospital Palermo, Italy, 90100 Contact: Antonio Carroccio, PHD Contact: Pasquale Mansueto, MD Sub-Investigator: Alberto D'Alcamo, MD Sub-Investigator: Giusi Randazzo, MD Sub-Investigator: Miriam Carta, MD Sub-Investigator: Giuseppe Taormina, MD
URL	https://clinicaltrials.gov/ct2/show/NCT01762579

Title	Tolerability of an Ancient Grain in Patients With Non-Celiac Wheat Sensitivity. A Clinical Study and a Search for Diagnostic Biomarkers.
NCT Number	NCT06191432
Conditions	Non-celiac Gluten Sensitivity
Interventions	Dietary Supplement: Administration of Triticum Monococcum flour Dietary Supplement: Administration of Triticum Aestivum flour
Sponsor/Collaborators	University of Palermo
Gender	All
Age	18 Years to 65 Years (Adult, Older Adult)
Phases
Enrollment	68 participants
Study Type	Interventional (Clinical Trial)
Study Designs	Allocation: RANDOMIZED\|Intervention Model: CROSSOVER\|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: DIAGNOSTIC
Start Date	05/01/2024
Completion Date	30/11/2026
Locations	A.O.U. Policlinico P. Giaccone di Palermo, Pasquale Mansueto, Antonio Carroccio
URL	https://www.clinicaltrials.gov/ct2/show/NCT06191432

Study Title	A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.
NCT Number	NCT06383403 Other IDs: CLIN-60190-463\|2024-510695-20-00
Conditions	Primary Biliary Cholangitis
Interventions	DRUG: Elafibranor\|OTHER: Placebo
Sponsor	Ipsen
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	69
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date	07/09/2024
Completion Date	31/10/2026
Locations	Calogero Cammà, UO Gastroenterologia, Policlinico Paolo Giaccone, Palermo, Italy
Study URL	https://clinicaltrials.gov/study/NCT06383403

Title	Observational Study on the Diagnosis and Management of Chronic Lymphocytic Leukemia (CLL) in Italy by Gruppo Italiano Malattie EMatologiche Dell'Adulto (GIMEMA)
NCT Number	NCT04867915 CLL2121
Conditions	Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma MBL-CLL - Monoclonal B-Cell Lymphocytosis Chronic Lymphocytic Leukaemia-Type
Interventions
Sponsor	Gruppo Italiano Malattie EMatologiche dell'Adulto
Gender	All
Age	18 Years and older (Adult, Older Adult)
Phases
Enrollment	12500 participants
Study Type	Observational
Study Designs	Case-Only
Start Date	13/10/2021
Completion Date	31/10/2026
Locations	A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL	https://www.clinicaltrials.gov/ct2/show/NCT04867915

Title	Eltrombopag for the Treatment of Thrombocytopenia Due to Low- and Intermediate Risk Myelodysplastic Syndromes (EQoL-MDS)
NCT Number	NCT02912208
Conditions	Myelodysplastic Syndromes Thrombocytopenia
Interventions
Sponsor	Associazione Qol-one
Gender	All
Age	18 Years and older (Adult, Older Adult)
Phases	Phase 2
Enrollment	174 participants
Study Type	Interventional (Clinical Trial)
Study Designs	Parallel Assignment
Start Date	11/06/2011
Completion Date	31/10/2026
Locations	A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL	https://www.clinicaltrials.gov/ct2/show/NCT02912208

Title	Patient-Reported Outcomes in PHiladelphia-nEgative Cytogenetic mYeloproliferative Neoplasms (PROPHECY): A GIMEMA Observational Registry for Italian MPN Patients
NCT Number	NCT04378855 QoL MPN0118
Conditions	Myeloproliferative Neoplasm Other: Questionnaire
Interventions
Sponsor	Gruppo Italiano Malattie EMatologiche dell'Adulto
Gender	All
Age	18 Years and older (Adult, Older Adult)
Phases	Phase 2
Enrollment	576 participants
Study Type	Observational
Study Designs	Cohort
Start Date	30/09/2020
Completion Date	31/10/2026
Locations	A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL	https://www.clinicaltrials.gov/ct2/show/NCT04378855

Study Title	Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia
NCT Number	NCT04579367 - Other IDs: DSE-BMP-01-20-EU
Conditions	Hypercholesterolemia\|Mixed Dyslipidemia
Interventions	DRUG: Bempedoic acid and/or its fixed-dose combination with ezetimibe
Sponsor	Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Gender	ALL
Age	ADULT, OLDER_ADULT
Phases
Enrollment	5000
Study Type	OBSERVATIONAL
Study Design	Observational Model: \|Time Perspective: p
Start Date	15/01/2021
Completion Date	30/10/2026
Locations	prof. Maurizio Averna, Medicina Interna e Dislipidemie Genetiche, Dir. Prof. Carlo Maria Barbagallo, A.O.U. Policlinico "P. Giaccone", Palermo, 90127, Italy\| Casa di Cura Triolo Zancla Hospital, Palermo, 90133, Italy\|
Study URL	https://clinicaltrials.gov/study/NCT04579367

Study Title	Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76)
NCT Number	NCT05712200 Other IDs: ANT-010\|2023-503224-66-00
Conditions	Atrial Fibrillation (AF)
Interventions	BIOLOGICAL: Abelacimab\|DRUG: Placebo
Sponsor	Anthos Therapeutics, Inc.
Sex	ALL
Age	OLDER_ADULT
Phases	PHASE3
Enrollment	1900
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)\|Primary Purpose: TREATMENT
Start Date	27/12/2022
Completion Date	01/10/2026
Locations	Prof. Angelo Baldassare Cefalù, AOU Policlinico, Palermo, Italy, 90127 Anthos Investigative Site 8017
Study URL	https://clinicaltrials.gov/study/NCT05712200

Title	Prospective Observational Study to Identify and Describe Predictive Factors for Thromboembolic Events in Patients With High-risk Polycythemia Vera
NCT Number	NCT05548062 CINC424BIT01
Conditions	Polycythemia Vera
Interventions	Other: Hydroxyurea Other: Ruxolitinib
Sponsor	Novartis ( Novartis Pharmaceuticals )
Gender	All
Age	18 Years to 99 Years (Adult, Older Adult)
Phases
Enrollment	300 participants
Study Type	Observational
Study Designs	Cohort
Start Date	02/03/2023
Completion Date	30/09/2026
Locations	A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL	https://www.clinicaltrials.gov/ct2/show/NCT05548062

Study Title	A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )
NCT Number	NCT04849728
Conditions	NASH - Nonalcoholic Steatohepatitis
Interventions	DRUG: IVA337\|DRUG: Placebo
Sponsor	Inventiva Pharma
Gender
Age
Phases	PHASE3
Enrollment	1000
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date	19/08/2021
Completion Date	30/09/2026
Locations	Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo, Italy\|
URL	https://clinicaltrials.gov/study/NCT04849728

Study Title	CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG) Studio in estensione in aperto di olezarsen (ISIS 678354) somministrato per via sottocutanea ipertrigliceridemia (SHTG)
NCT Number	NCT05681351 ISIS 678354-CS15 Codice EU CT: 2022-501999-26-00
Conditions	Severe Hypertriglyceridemia
Interventions	DRUG: Olezarsen
Sponsor/Collaborators	Ionis Pharmaceuticals, Inc. - Medpace Clinical Research LLC
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	800
Study Type	INTERVENTIONAL
Study Design	Allocation: NA\|Intervention Model: SINGLE_GROUP\|Masking: NONE\|Primary Purpose: TREATMENT
Start Date	13/12/2022
Completion Date	01/09/2026
Locations	Prof. Angelo Baldassare Cefalù, UOC di Astanteria MCAU, Azienda Ospedaliera Universitaria Policlinico, Palermo, 90127, Italy
Study URL	https://clinicaltrials.gov/study/NCT05681351

Study Title	Multidimensional Approach for COPD and High Complexity
NCT Number	NCT04986332
Conditions	Chronic Obstructive Pulmonary Disease\|Heart Failure\|Chronic Disease
Interventions	BEHAVIORAL: Physical activity program\|OTHER: Global therapeutic remodeling
Sponsor	Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Gender
Age
Phases
Enrollment	300
Study Type	INTERVENTIONAL
Study Design	Allocation: NON_RANDOMIZED\|Intervention Model: PARALLEL\|Masking: NONE\|Primary Purpose: TREATMENT
Start Date	01/09/2021
Completion Date	01/09/2026
Locations	prof. Domenico Di Raimondo, Palermo, 90127, Italy
URL	https://clinicaltrials.gov/study/NCT04986332

Study Title	A Proof-of-Concept Study to Assess the Efficacy, Safety and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Non-cystic Fibrosis Bronchiectasis
NCT Number	NCT06280391 Other Ids: ACT18018\|U1111-1295-3237\|2023-508663-70
Conditions	Bronchiectasis
Interventions	DRUG: Itepekimab (SAR440340)\|DRUG: Placebo
Sponsor/Collaborators	Sanofi/Regeneron Pharmaceuticals
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE2
Enrollment	300
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)\|Primary Purpose: TREATMENT
Start Date	20/02/2024
Completion Date	11/08/2026
Locations	Investigational Site Number : 3800001, Milan, Lombardia, 20122, Italy\|Investigational Site Number : 3800002, Rozzano, Milano, 20089, Italy\|Investigational Prof. Salvatore Battaglia, U.O. Pneumologia, Policlinico "Paolo Giaccone", Site Number : 3800004, Pa
Study URL	https://clinicaltrials.gov/study/NCT06280391

Study Title	A Study to Evaluate the Effect of Venglustat Tablets on Neuropathic and Abdominal Pain in Male and Female Adult Participants With Fabry Disease
NCT Number	NCT05206773
Conditions	Fabry Disease
Interventions	DRUG: Venglustat (GZ402671)\|DRUG: Placebo
Sponsor	Genzyme, a Sanofi Company
Gender
Age
Phases	PHASE3
Enrollment	114
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)\|Primary Purpose: TREATMENT
Start Date	03/11/2022
Completion Date	07/08/2026
Locations	Azienda Ospedaliera Universitaria_Investigational Site Number: 3800003, Palermo, 90127, Italy, Prof. Antonino Tuttolomondo
URL	https://clinicaltrials.gov/study/NCT05206773

Title	A Phase 2b, Open-label, Multicenter, Randomized, Controlled, 2-Arm Study to Assess the Efficacy and Safety of Orally Administered NS-018 versus Best Available Therapy in Subjects with Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis with Severe Thrombocytopenia (Platelet Count <50,000/µL) Studio di Fase 2b, in aperto, multicentrico, randomizzato, controllato, a 2 bracci per valutare l’efficacia e la sicurezza di NS-018 somministrato per via orale rispetto alla migliore terapia disponibile in soggetti con mielofibrosi primaria, mielofibrosi post-policitemia vera o mielofibrosi post-trombocitemia essenziale con trombocitopenia grave (conta piastrinica <50.000/µl)
EudraCT number	2021-000369-34 NS-018-201
Conditions	Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis with Severe Thrombocytopenia Mielofibrosi primaria, mielofibrosi post-policitemia vera o mielofibrosi posttrombocitemia essenziale con grave trombocitopenia
Interventions
Sponsor/Collaborators	NS Pharma, Inc, IQVIA Biotech
Gender	Female; Male
Age	Adults; Elderly;
Phases	Phase II
Enrollment	120
Study Type	Therapeutic exploratory (Phase II)
Study Design	Controlled; Randomised; Open;
Start Date	02/07/2023
Completion Date	01/07/2026
Locations	A.O.U. Policlinico P. Giaccone Palermo, Prof. Sergio Siragusa, U.O.C. di Ematologia
URL	https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-000369-34/IT

Study Title	A Study Evaluating the Effect of Filgotinib in Participants With Active Axial Spondyloarthritis
NCT Number	NCT05785611 Other IDs: GLPG0634-CL-336 \| 2022-501354-10-01
Conditions	Axial Spondyloarthritis
Interventions	DRUG: Filgotinib\|DRUG: Placebo
Sponsor	Alfasigma S.p.A. Galapagos NV
Gender	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	495
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)\|Primary Purpose: TREATMENT
Start Date	05/04/2023
Completion Date	01/07/2026
Locations	Prof.^ssa Giuliana Guggino, UOC Reumatologia, Policlinico Paolo Giaccone, Palermo, 90127, Italy\|
Study URL	https://clinicaltrials.gov/study/NCT05785611

Title	Non-Interventional Study of the Change in Joint Health in Adult Patients With Haemophilia A After Switching to Prophylaxis With Turoctocog Alfa Pegol (N8-GP)
NCT Number	NCT05621746 - NN7088-4928
Conditions	Intervention/treatment Haemophilia A Drug: Esperoct
Interventions
Sponsor	Novo Nordisk A/S
Gender	Male
Age	18 Years and older (Adult, Older Adult)
Phases
Enrollment	100 participants
Study Type	Observational
Study Designs	Cohort
Start Date	23/11/2022
Completion Date	30/06/2026
Locations	A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. Ematologia, prof.^ssa Mariasanta Napolitano
URL	https://www.clinicaltrials.gov/ct2/show/NCT05621746

Study Title	A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab
NCT Number	NCT04770896 Othr ID: MO42541
Conditions	Unresectable Hepatocellular Carcinoma
Interventions	DRUG: Atezolizumab\|DRUG: Lenvatinib\|DRUG: Sorafenib
Sponsor	Hoffmann-La Roche - Collaborators:
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	554
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: NONE\|Primary Purpose: TREATMENT
Start Date	26/04/2021
Completion Date	23/09/2024
Locations	A.O.U. Policlinico Paolo Giaccone; Gastroenterologia ed Epatologia, Palermo, Sicilia, 90127, Italy\|
Study URL	https://clinicaltrials.gov/study/NCT04770896

Title	ZEUS - Effects of ziltivekimab versus placebo on cardiovascular outcomes in participants with established atherosclerotic cardiovascular disease, chronic kidney disease and systemic inflammation ZEUS - Effetti di ziltivekimab versus placebo sugli esiti cardiovascolari in soggetti con malattia cardiovascolare aterosclerotica accertata, patologia renale cronica e infiammazione sistemica
EudraCT number	2020-004853-59 - NCT05021835 - EX6018-4758
Conditions	Atherosclerotic cardiovascular disease Chronic kidney disease Systemic inflammation Malattia cardiovascolare aterosclerotica Malattia renale cronica Infiammazione sistemica
Interventions
Sponsor/Collaborators	NOVO NORDISK. S.P.A.
Gender	Female; Male
Age	Adults; Elderly;
Phases	Phase III
Enrollment	6200
Study Type	Therapeutic confirmatory (Phase III)
Study Design	Controlled; Randomised; Parallel group;
Start Date	20/08/2021
Completion Date	26/06/2026
Locations	A.O.U. Policlinico P. Giaccone Palermo, TUTTOLOMONDO ANTONINO
URL	https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-004853-59/IT

Title	Real-world Effectiveness and Treatment Patterns of Upadacitinib in Monotherapy or Used in Combination With Methotrexate in Active Psoriatic Arthritis Patients
NCT Number	NCT05616871 P22-897
Conditions	Psoriatic Arthritis
Interventions
Sponsor	AbbVie
Gender	All
Age	18 Years and older (Adult, Older Adult)
Phases
Enrollment	450 participants
Study Type	Observational
Study Designs	Cohort
Start Date	15/12/2022
Completion Date	14/06/2026
Locations	A.O.U. Policlinico P. Giaccone di Palermo, Prof.^ssa Giuliana Guggino, U.O.C. di Reumatologia
URL	https://www.clinicaltrials.gov/ct2/show/NCT05616871

Title	A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Subcutaneously Administered Guselkumab in Improving the Signs and Symptoms and Inhibiting Radiographic Progression in Participants with Active Psoriatic Arthritis. Studio multicentrico di fase 3b, randomizzato, in doppio cieco, controllato con placebo per valutare l’efficacia e la sicurezza di guselkumab somministrato per via sottocutanea nel migliorare i segni e sintomi e nell’inibire la progressione radiografica nei partecipanti con artrite psoriasica attiva.
EudraCT number	2020-004981-20
Medical condition	Psoriatic arthritis (PsA) Artrite psoriasica (AP)
Interventions
Sponsor/Collaborators	JANSSEN CILAG INTERNATIONAL NV
Gender	Female; Male
Population Age	Adults; Elderly;
Phases	Phase III
Enrollment	950
Trial type	Therapeutic confirmatory (Phase III)
Design of the trial	Controlled; Randomised;
Start Date	15/09/2021
Completion Date	11/06/2026
Locations	A.O.U. Policlinico P. Giaccone Palermo, U.O.C. Dermatologia, Prof.ssa Maria Rita Bongiorno
URL	https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-004981-20/IT

Study Title	Can Gluten/wheat or Other Foods Be Responsible for FMF Attacks
NCT Number	NCT06338891 - Other Ids ACPM34
Conditions	Familial Mediterranean Fever\|Non-celiac Gluten Sensitivity
Interventions	OTHER: Main questionnaire\|OTHER: Secondary questionnaire
Sponsor	University of Palermo
Sex	ALL
Age	CHILD, ADULT, OLDER_ADULT
Phases
Enrollment	60
Study Type	OBSERVATIONAL
Study Design
Start Date	01/05/2024
Completion Date	01/05/2026
Locations	University Hospital of Palermo, Palermo, Sicily, 90127, Italy, Contact: Antonio Carroccio, Pasquale Mansueto
Study URL	https://clinicaltrials.gov/study/NCT06338891

Title	Phase 3 Multicenter, Randomized, Double-Blind, Study to Assess the Efficacy and Safety of Treatment with Bepirovirsen in HBeAg-negative Nucleos(t)ide Analogue-treated Participants with Chronic Hepatitis B Virus (B-Well 2) Studio di Fase 3, multicentrico, randomizzato, in doppio cieco, per valutare l’efficacia e la sicurezza del trattamento con bepirovirsen in partecipanti con infezione cronica da virus dell’epatite B negativi per HBeAg trattati con analoghi nucleosidici o nucleotidici (B-Well 2).
EudraCT number	2022-002268-53
Conditions	Chronic Hepatitis B infection Infezione cronica da Epatite B
Interventions
Sponsor/Collaborators	GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT
Gender	Female; Male
Age	Adults; Elderly;
Phases	Phase III
Enrollment	534
Study Type	Therapeutic confirmatory (Phase III)
Study Design	Controlled; Randomised;
Start Date	28/11/2022
Completion Date	27/03/2026
Locations	United Kingdom - A.O.U. Policlinico P. Giaccone Palermo, DI MARCO VITO
URL	https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-002268-53/IT

Title	A Phase 2, prospective, multi-center intervention trial in patients with acute myeloid leukemia secondary to myeloproliferative neoplasms unfit for intensive chemotherapy investigating a treatment combination including decitabine and venetoclax. ENABLE (vENetoclax plus decitAbine treatment in Blastic phase of myeLoproliferative nEoplasms) Studio interventistico di fase II, prospettico, multicentrico, in pazienti affetti da leucemia mieloide acuta secondaria a neoplasie mieloproliferative non eleggibili per chemioterapia intensiva, per valutare una terapia di combinazione con decitabina e venetoclax.
EudraCT number	2020-006114-20 AML2420; ENABLE
Conditions	Acute Myeloid Leukemia secondary to myeloproliferative neoplasms Leucemia Mieloide Acuta secondaria a neoplasie mieloproliferative
Interventions
Sponsor Name	FONDAZIONE GIMEMA (GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL' ADULTO) FRANCO MANDELLI ONLUS
Gender	Female; Male
Age	Adults; Elderly;
Phases	Phase II
Enrollment	101
Study Type	Therapeutic exploratory (Phase II)
Study Designs	Controlled; Open;
Start Date	17/09/2021
Completion Date	15/03/2026
Locations	Italy - A.O.U. Policlinico P. Giaccone Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL	https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-006114-20/IT

Title	An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined with Ruxolitinib in Patients with Primary Myelofibrosis (PMF), Post–Polycythemia Vera MF (Post–PV-MF), Or Post–Essential Thrombocythemia MF (Post-ET-MF) Who Have a Suboptimal Response to Ruxolitinib Studio di fase 1b/2 in aperto, multicentrico per valutare la sicurezza e l’efficacia di KRT-232 in combinazione con ruxolitinib in pazienti con mielofibrosi primaria (PMF), MF post-policitemia vera (Post-PV-MF) o MF post-trombocitemia essenziale (Post-ET-MF) che rispondono a ruxolitinib in maniera subottimale
EudraCT number	2019-004554-29 - NCT04485260 - KRT-232-109
Conditions	Primary Myelofibrosis (PMF), Post–Polycythemia Vera MF (Post–PV-MF), Or Post–Essential Thrombocythemia MF (Post-ET-MF) Mielofibrosi primaria (PMF), Post – Policitemia Vera MF (Post – PV-MF) o Trombocitemia post-essenziale MF (Post-ET-MF)
Interventions
Sponsor Name	Kartos Therapeutics, Inc
Gender	Female; Male
Age	Adults; Elderly;
Phases	Phase II
Enrollment	78
Study Type	Therapeutic exploratory (Phase II)
Study Designs	Sicurezza ed efficacia di KRT-232 con Ruxolitinib nei pazienti con PMF, Post – PV-MF, Post-ET-MF Safety and Efficacy of KRT-232 with Ruxolitinib in Patients with PMF, Post–PV-MF, Post-ET-MF
Start Date	11/03/2020
Completion Date	10/03/2026
Locations	United States Italy: A.O.U. Policlinico P. Giaccone Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL	https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-004554-29/IT https://www.clinicaltrials.gov/ct2/show/NCT04485260

Study Title	Functional Assessment in Elderly MI Patients With Multivessel Disease
NCT Number	NCT03772743 Other IDs: 56/2019/Sper/AOUFe
Conditions	Myocardial Infarction
Interventions	OTHER: Culprit-only revascularization\|OTHER: Complete functionally-guided revascularization
Sponsor	Consorzio Futuro in Ricerca
Gender	ALL
Age	OLDER_ADULT
Phases	NA
Enrollment	1445
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: NONE\|Primary Purpose: TREATMENT
Start Date	15/07/2019
Completion Date	10/03/2026
Locations	prof. A.R. Galassi, AOUP P. Giaccone, Palermo, Italy
Study URL	https://clinicaltrials.gov/study/NCT03772743

Study Title	A Clinical Study of Efinopegdutide in Participants With Precirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-6024-013)
NCT Number	NCT05877547 Other IDs: 6024-013\|2022-502647-35-00\|MK-6024-013\|jRCT2031230187
Conditions	Non-alcoholic Fatty Liver Disease\|Fatty Liver, Nonalcoholic\|NAFLD\|Nonalcoholic Fatty Liver Disease\|Nonalcoholic Steatohepatitis
Interventions	DRUG: Efinopegdutide\|DRUG: Semaglutide\|DRUG: Placebo
Sponsor	Merck Sharp & Dohme LLC
Gender	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE2
Enrollment	300
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date	23/06/2023
Completion Date	13/02/2026
Locations	A.O.U. Policlinico Paolo Giaccone-Dep. Of Internal Medicine and Specialistic (Site 1402), Palermo, Sicilia, 90127, Italy\|
Study URL	https://clinicaltrials.gov/study/NCT05877547

Study Title	A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)
NCT Number	NCT06077864 Other IDs: 1404-0040\|2022-502442-27-00\|U1111-1289-0174
Conditions	Obesity
Interventions	DRUG: survodutide\|DRUG: Placebo
Sponsor	Boehringer Ingelheim
Gender	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	4935
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date	17/11/2023
Completion Date	04/02/2026
Locations	A.O. Univ. Policlinico "Paolo Giaccone", Palermo, 90127, Italy\|
Study URL	https://clinicaltrials.gov/study/NCT06077864

Study Title	Lifestyles Implemented-Survivorship Care Plan in Lymphoma Survivors
NCT Number	NCT05934084 Other IDs: FIL_Lymphoma-SCP
Conditions	Classical Hodgkin Lymphoma Diffuse Large B Cell Lymphoma (DLBCL) Primary Mediastinal Large B-cell Lymphoma (PMBCL)
Interventions	Behavioral: Lifestyles Implemented-Survivorship Care Plan (LS-SCP)
Sponsor	Fondazione Italiana Linfomi - ETS IRCCS Istituto Tumori Giovanni Paolo II di Bari
Gender	ALL
Age	18 Years to 50 Years (Adult )
Phases
Enrollment	552
Study Type	INTERVENTIONAL
Study Design	Primary Purpose : Other Allocation : Randomized Interventional Model : Parallel Assignment Interventional Model Description: It's a longitudinal study with two time-points (6 months and 12 months) after baseline (time 0) and the data will be evaluated by means of ANOVA for repeated measures, considering as baseline the global QoL of 75. Masking : None (Open Label)
Start Date	26/02/2024
Completion Date	01/02/2026
Locations	A.O. Univ. Policlinico "Paolo Giaccone", Ematologia, prof.^ssa Salvatrice Mancuso
Study URL	https://www.clinicaltrials.gov/study/NCT05934084

Title	Quality Of Life On Elderly Patients With Low Grade Non-Hodgkin Lymphoma Treated With Immunotherapy Or Immunochemotherapy And/Or Radiotherapy: An Observational Prospective Study Of The Fondazione Italiana Linfomi
NCT Number	NCT05524298 - FIL_QoL-ELDIND
Conditions	Low Grade Non-Hodgkin's Lymphoma, Adult
Interventions
Sponsor	Fondazione Italiana Linfomi ONLUS
Gender	All
Age	70 Years and older (Older Adult)
Phases
Enrollment	150 participants
Study Type	Observational
Study Designs	Cohort
Start Date	01/09/2022
Completion Date	01/02/2026
Locations	A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Dott.^ssa Salvatrice Mancuso
URL	https://www.clinicaltrials.gov/ct2/show/NCT05524298

Study Title	Study for Elderly (≥ 65 Years) Patients With Classical Hodgkin Lymphoma Undergoing CGA at Diagnosis Raccolta prospettica di dati di pazienti anziani (≥65 aa) con linfoma di Hodgkin di tipo classico sottoposti al momento della diagnosi a valutazione geriatrica multidimensionale (VGM)
NCT Number	NCT03552003 Other IDs: FIL_ELDHL
Conditions	Classical Hodgkin Lymphoma
Interventions	Other: Treatment for clinical practise
Sponsor	Fondazione Italiana Linfomi - ETS
Gender	ALL
Age	65 Years and older (Older Adult)
Phases
Enrollment	400
Study Type	Observational
Study Design	Observational Model : Cohort Time Perspective: Prospective Biospecimen Retention: Samples Without DNA Biospecimen Description: Mandatory: paraffin block for diagnosis review Optional: paraffin block for TISSUE MICRO ARRAYS analyses 3ml blood adsorbed on a swab tip for IMMUNO SENESCENCE AND FRAILTY evaluation 3ml blood adsorbed on a swab tip for IMMUNO SENESCENCE AND TORQUE TENO VIRUS evaluation
Start Date	10/08/2018
Completion Date	31/01/2026
Locations	A.O. Univ. Policlinico "Paolo Giaccone", Ematologia, prof.^ssa Salvatrice Mancuso
Study URL	https://clinicaltrials.gov/study/NCT03552003

Study Title	A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor
NCT Number	NCT06065540 Other IDs: NN9388-4896\|U1111-1283-0427\|2022-502678-18
Conditions	Type 2 Diabetes Mellitus
Interventions	DRUG: Cagrilintide\|DRUG: Semaglutide\|DRUG: Placebo cagrilintide\|DRUG: Placebo semaglutide
Sponsor	Novo Nordisk A/S
Gender	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	2700
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date	27/09/2023
Completion Date	14/01/2026
Locations	AOUP Giaccone Palermo, Palermo, 90127, Italy\| Dip. di Medicina Interna Policlinico Universitario Palermo, Palermo, 90127, Italy\|
Study URL	https://clinicaltrials.gov/study/NCT06065540

Study Title	Cardiovascular Outcome Study to Evaluate the Effect of Obicetrapib in Patients With Cardiovascular Disease
NCT Number	NCT05202509 Other IDs: TA-8995-304
Conditions	Atherosclerotic Cardiovascular Disease
Interventions	DRUG: Obicetrapib\|DRUG: Placebo
Sponsor	NewAmsterdam Pharma
Gender	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	9000
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date	02/07/2022
Completion Date	12/01/2026
Locations	Prof. Giuseppina Novo, Cardiologia, Centro per la Diagnosi Precoce di Aterosclerosi Preclinica e Pluridistrettuale per la Prevenzione Secondaria, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo, 90127, Italy
Study URL	https://clinicaltrials.gov/study/NCT05202509

Study Title	Ketogenic Diet in MASLD-related cACLD
NCT Number	NCT06537466 Other IDs: KETOMASH
Conditions	Steatohepatitis, Nonalcoholic\|Steatosis of Liver\|Cirrhosis, Liver
Interventions	DIETARY_SUPPLEMENT: Mediterranean diet\|DIETARY_SUPPLEMENT: Very Low Ketogenic Diet
Sponsor	University of Palermo
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases	NA
Enrollment	50
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: NONE\|Primary Purpose: TREATMENT
Start Date	11/01/2024
Completion Date	11/01/2026
Locations	Calogero Cammà, Section of Gastroenterology, PROMISE, University of Palermo, Palermo, Italy
Study URL	https://clinicaltrials.gov/study/NCT06537466

Study Title	Study of Plozasiran (ARO-APOC3) in Adults With Severe Hypertriglyceridemia
NCT Number	NCT06347003 Other IDs: AROAPOC3-3003\|2023-509300-14
Conditions	Severe Hypertriglyceridemia
Interventions	DRUG: Plozasiran Injection\|DRUG: Placebo
Sponsor	Arrowhead Pharmaceuticals
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	405
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date	22/07/2024
Completion Date	10/01/2026
Locations	Prof. Angelo Baldassare Cefalù, UOC di Astanteria MCAU, A.O.U. Policlinico, Palermo, 90127, Italy
Study URL	https://clinicaltrials.gov/study/NCT06347003

Study Title	Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia
NCT Number	NCT06347133 Other IDs: AROAPOC3-3009\|2023-509302-30
Conditions	Hypertriglyceridemia
Interventions	DRUG: Plozasiran Injection\|DRUG: Placebo
Sponsor	Arrowhead Pharmaceuticals
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	1328
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date	21/05/2024
Completion Date	10/01/2026
Locations	Calogero Cammà, Section of Gastroenterology, PROMISE, University of Palermo, Palermo, Italy
Study URL	https://clinicaltrials.gov/study/NCT06347133

Study Title	Multidimensional Approach for COPD and High Complexity
NCT Number	NCT04986332 Other IDs: MACH Study
Conditions	Chronic Obstructive Pulmonary Disease\|Heart Failure\|Chronic Disease
Interventions	BEHAVIORAL: Physical activity program\|OTHER: Global therapeutic remodeling
Sponsor	Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Gender	ALL
Age	ADULT, OLDER_ADULT
Phases	NA
Enrollment	300
Study Type	INTERVENTIONAL
Study Design	Allocation: NON_RANDOMIZED\|Intervention Model: PARALLEL\|Masking: NONE\|Primary Purpose: TREATMENT
Start Date	09/01/2021
Completion Date	09/01/2026
Locations	Domenico Di Raimondo, Palermo, 90127, Italy
Study URL	https://clinicaltrials.gov/study/NCT04986332

Title	A Phase II, Multicenter, Double-Blind, Randomised, Placebo-Controlled Study and Open-Label Long Term Extension to Evaluate the Safety and Efficacy of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis (PSC)
EudraCT number	2022-002695-37 NCT05627362 CLIN-60190-453
Conditions	Adults patients with Primary Sclerosing Cholangitis (PSC) Pacientes adultos con colangitis esclerosante primaria (CEP)
Interventions
Sponsor	Ipsen Bioscience, Inc.
Gender	Female; Male
Age	Adults; Elderly;
Phases	Phase II
Enrollment	61
Study Type	Therapeutic exploratory (Phase II)
Study Designs	Controlled; Randomised; Parallel group;
Start Date	13/02/2023
Completion Date	08/01/2026
Locations	Italy - A.O.U. Policlinico P. Giaccone Palermo, UOC di Gastroenterologia, Prof.^ssa Vincenza Calvaruso
URL	https://www.clinicaltrials.gov/ct2/show/NCT05627362 https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-002695-37/ES

Study Title	Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera
NCT Number	NCT06093672 Other IDs: DSC/08/2357/32
Conditions	Polycythemia Vera
Interventions	DRUG: Givinostat\|DRUG: Hydroxyurea
Sponsor	Italfarmaco
Sex	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	220
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: SINGLE (OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date	26/03/2024
Completion Date	07/01/2026
Locations	A.O.U. Policlinico P. Giaccone Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
Study URL	https://clinicaltrials.gov/study/NCT06093672

Study Title	A Multicenter Observational Registry to Evaluate Safety and Performance of Vivo ISAR (SECURE Global Registry)
NCT Number	NCT06412250 Other IDs: TL/SECURE/VIVO/2023-01
Conditions	Cardiovascular Diseases
Interventions
Sponsor	Sponsor: Translumina Therapeutics LLP - Collaborators: Iqvia Pty Ltd
Gender	ALL
Age	ADULT, OLDER_ADULT
Phases
Enrollment	2000
Study Type	OBSERVATIONAL
Study Design	Observational Model: \|Time Perspective: p
Start Date	01/10/2024
Completion Date	05/01/2026
Locations	Dr. Salvatore Evola, Prof.^ssa GIUSEPPINA NOVO, Cardiologia, Aoup Paolo Giaccone, Palermo, 90127, Italy\|
Study URL	https://clinicaltrials.gov/study/NCT06412250

Study Title	A Study of Oral Ladarixin in Recent Onset Type 1 Diabetes and a Low Residual β-cell Function
NCT Number	NCT04628481 Other IDs: LDX0319\|2020-001926-71
Conditions	New-onset type1 Diabetes
Interventions	DRUG: Ladarixin\|DRUG: Placebo
Sponsor	Dompé Farmaceutici S.p.A
Gender	ALL
Age	CHILD, ADULT
Phases	PHASE3
Enrollment	327
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date	21/12/2020
Completion Date	03/01/2026
Locations	prof.^ssa Carla Giordano, U.O. Malattie Endocrine, del Ricambio e della Nutrizione, Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone", Palermo, 90127, Italy\|
Study URL	https://clinicaltrials.gov/study/NCT04628481

Study Title	Oxygen-ozone Therapy Plus Antibiotic Therapy in the Treatment of Infections Secondary to Implant of Orthopaedic Devices
NCT Number	NCT04787575 Other IDs: sOO3T1 Study
Conditions	Infection
Interventions	PROCEDURE: Oxygen-ozone therapy
Sponsor	Società Scientifica Internazionale di Ossigeno Ozono Terapia
Gender	ALL
Age	ADULT, OLDER_ADULT
Phases	NA
Enrollment	186
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: NONE\|Primary Purpose: TREATMENT
Start Date	24/01/2024
Completion Date	01/01/2026
Locations	Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone di Palermo, Palermo, Italy\|
Study URL	https://clinicaltrials.gov/study/NCT04787575

Title	An 18-month Low-interventional Prospective, Multicentre Study to Assess Joint Outcomes in Patients With Haemophilia A or B on Prophylaxis With Efmoroctocog Alfa or Eftrenonacog Alfa
NCT Number	NCT05856266
Conditions	Hemophilia A Hemophilia B
Interventions	Procedure: Haemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) Other: Haemophilia Joint Health Score (HJHS)
Sponsor	Swedish Orphan Biovitrum
Gender	All
Age	6 Years and older (Child, Adult, Older Adult)
Phases	Phase 4
Enrollment	250 participants
Study Type	Interventional (Clinical Trial)
Study Designs	Single Group Assignment
Start Date	24/07/2023
Completion Date	01/01/2026
Locations	A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. Ematologia, prof.^ssa Mariasanta Napolitano
URL	https://www.clinicaltrials.gov/ct2/show/NCT05856266