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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/presunta cade nell'anno corrente o in anno successivo]

[#TOT Trial in corso: 93] - [ultimo aggiornamento: 28/03/2025]

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	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

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

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	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	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	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

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

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	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

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

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

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

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	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	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	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

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	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
Conditions
Interventions	Parallel Assignment
Sponsor
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	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

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

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

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 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\|
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	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	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, AOU 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

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	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	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

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	31/12/2025
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/

Title	A Phase 3, Multi-center, Randomized, Quadruple-masked, Placebo-controlled Study of Batoclimab for the Treatment of Participants with Active Thyroid Eye Disease (TED) Studio controllato con placebo di fase 3, multicentrico, randomizzato, in quadruplo cieco di batoclimab per il trattamento di partecipanti affetti da oftalmopatia tiroidea (TED) attiva
EudraCT number	2022-002787-68
Conditions	Thyroid Eye Disease (TED) Oftalmopatia tiroidea (TED) attiva
Interventions
Sponsor/Collaborators	Immunovant Sciences GmbH
Gender	Female; Male
Age	Adults; Elderly;
Phases	Phase III
Enrollment	100
Study Type	Therapeutic confirmatory (Phase III)
Study Design	Controlled; Randomised;
Start Date	02/10/2023
Completion Date	30/12/2025
Locations	Switzerland - A.O.U. Policlinico P. Giaccone Palermo, GUARNOTTA VALENTINA
URL	https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-002787-68/IT

Title	A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ISIS 678354 Administered Subcutaneously to Patients With Severe Hypertriglyceridemia
NCT Number	NCT05079919 - (EudraCT Number: 2021-002192-19)
Conditions	Severe Hypertriglyceridemia
Interventions	Drug: Olezarsen Drug: Placebo
Sponsor	Ionis Pharmaceuticals, Inc.
Gender	All
Age	18 Years and older (Adult, Older Adult)
Phases	Phase 3
Enrollment	540
Study Type	Interventional
Study Designs	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment
Start Date	25/10/2021
Completion Date	13/12/2025
Locations	Italy Ospdale E. Bassini - Milano, Italy, 20092 A.O. Policlinico Universitario P. Giaccone - Palermo, Italy, 90127 Policlinico Umberto - Roma, Italy, 00161 and other 94 international study locations
URL	https://ClinicalTrials.gov/show/NCT05079919

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.
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	01/12/2025
Locations	Sperimentatore: Prof.^ssa V. Calvaruso; Centro: U.O.C. di Gastroenterologia ed Epatologia A.O.U. Policlinico P. Giaccone di Palermo; Promotore: CymaBay Therapeutics, Inc. CRO: PPD Italy s.r.l.
URL	https://clinicaltrials.gov/ct2/show/NCT03301506

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	Pasquale Mansueto, 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	Crossover Assignment
Start Date	05/01/2024
Completion Date	30/11/2025
Locations	A.O.U. Policlinico P. Giaccone di Palermo, Pasquale Mansueto, Antonio Carroccio
URL	https://www.clinicaltrials.gov/ct2/show/NCT06191432

Title	A Randomised, Double-blind, Placebo-Controlled, Multi-Center Phase 2b Study to Evaluate the Efficacy, Safety and Tolerability of AZD2693 in Participants with Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH) with Fibrosis Who Are Carriers of the PNPLA3 rs738409 148M Risk Allele Studio di fase IIb randomizzato, multicentrico, in doppio cieco, controllato con placebo volto a valutare l’efficacia, la sicurezza e la tollerabilità di AZD2693 in pazienti affetti da steatoepatite non alcolica non cirrotica (NASH) con fibrosi e portatori dell’allele di rischio di PNPLA3 rs738409 148M
EudraCT number	2022-001629-65 D7830C00004
Conditions	Non-cirrhotic non-alcoholic steatohepatitis with fibrosis Steatoepatite non alcolica non cirrotica con fibrosi
Interventions
Sponsor/Collaborators	ASTRAZENECA AB
Gender	Female; Male
Age	Adults; Elderly;
Phases	Phase II
Enrollment	318
Study Type	Therapeutic exploratory (Phase II)
Study Design	Controlled; Randomised; Parallel group;
Start Date	13/03/2023
Completion Date	08/10/2025
Locations	A.O.U. Policlinico P. Giaccone Palermo, Prof. Salvatore Petta, U.O.C. di Gastroenterologia
URL	https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-001629-65/IT

Title	A Phase 3, prospective, randomized multi-center intervention trial of early intensification in AML patients bearing FLT3 mutations based on peripheral blast clearance. A MYNERVA-GIMEMA study. AMELIORATE (AML Early IntensificatiOn based on peRipheral blAsT clEarance)
EudraCT Number	2019-003936-21 AML1919/AMELIORATE
Conditions	Acute Myeloid Leukemia (LMA) with FLT3 mutation
Interventions
Sponsor Name	FONDAZIONE GIMEMA (GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL' ADULTO) FRANCO MANDELLI ONLUS
Gender	All
Age	Adults, Elderly
Phases	III
Enrollment	172
Study Type	Therapeutic confirmatory (Phase III)
Study Designs	Controlled, Randomised, Open, Parallel group, Comparison of standard therapy vs. experimental therapeutic approach
Start Date	09/04/2020
Completion Date	05/10/2025
Locations	A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa, Dott.^ssa Mitra
URL	https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-003936-21/IT

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 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	18/09/2025
Locations	Denmark - A.O.U. Policlinico P. Giaccone Palermo, TUTTOLOMONDO ANTONINO
URL	https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-004853-59/IT

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
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, Investigator)
Start Date	14/02/2022
Completion Date	15/09/2025
Locations	Sperimentatore: Dott.^ssa V. Calvaruso Centro: U.O.C. di Gastroenterologia Promotore: Genkyotex Suisse SA CRO: Pharmaceutical Research Associates Italy S.r.l.
URL	https://clinicaltrials.gov/ct2/show/NCT05014672

Title	An Open-label Extension Study for Participants who Completed Study IMVT-1401-3201 or Study IMVT-1401-3202 to Assess the Efficacy and Safety of Batoclimab for the Treatment of Thyroid Eye Disease (TED) Studio di estensione in aperto per partecipanti che hanno completato lo studio IMVT-1401-3201 o lo studio IMVT-1401-3202 per valutare l’efficacia e la sicurezza di batoclimab per il trattamento dell’oftalmopatia tiroidea (TED)
EudraCT number	2022-002839-66
Conditions	Thyroid Eye Disease (TED) Oftalmopatia tiroidea (TED)
Interventions
Sponsor/Collaborators	Immunovant Sciences GmbH
Gender	Female; Male
Age	Adults; Elderly;
Phases	Phase III
Enrollment	180
Study Type	Therapeutic confirmatory (Phase III)
Study Design
Start Date	23/02/2023
Completion Date	22/07/2025
Locations	Switzerland - A.O.U. Policlinico P. Giaccone Palermo, GUARNOTTA VALENTINA
URL	https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-002839-66/IT

Title	A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study of Olezarsen (ISIS 678354) in Patients With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), or With Severe Hypertriglyceridemia
NCT Number	NCT05610280 ISIS 678354-CS9 2022-501486-53 ( EudraCT Number )
Conditions	Hypertriglyceridemia Cardiovascular Diseases Atherosclerosis
Interventions	Drug: Olezarsen Drug: Placebo
Sponsor	Ionis Pharmaceuticals, Inc.
Gender	All
Age	18 Years and older (Adult, Older Adult)
Phases
Enrollment	1312 participants
Study Type	Interventional (Clinical Trial)
Study Designs	Parallel Assignment
Start Date	21/11/2022
Completion Date	01/06/2025
Locations	A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. Astanteria/MCAU, prof. Angelo Baldassare Cefalù
URL	https://www.clinicaltrials.gov/ct2/show/NCT05610280

Title	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of TAK-062 for the Treatment of Active Celiac Disease in Subjects Attempting a Gluten-Free Diet
NCT Number	NCT05353985 TAK-062-2001 2020-005438-14 ( EudraCT Number )
Conditions	Celiac Disease
Interventions	Drug: TAK-062 Dietary Supplement: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-Bar Drug: TAK-062 Placebo Dietary Supplement: Simulated Inadvertent Gluten Exposure (SIGE) Gluten-free Bar
Sponsor	Takeda
Gender	All
Age	12 Years and older (Child, Adult, Older Adult)
Phases	Phase 2
Enrollment	377 participants
Study Type	Interventional (Clinical Trial)
Study Designs	Parallel Assignment
Start Date	30/06/2022
Completion Date	06/05/2025
Locations	A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. Geriatria, prof. Pasquale Mansueto
URL	https://www.clinicaltrials.gov/ct2/show/NCT05353985

Title	An Observational, Multicenter Study to Evaluate the Use and Effectiveness of Doptelet® (Avatrombopag) in Adult Patients With Immune Thrombocytopenia (ITP)
NCT Number	NCT04943042 Sobi.Doptelet-001
Conditions	Intervention/treatment Immune Thrombocytopenia ITP
Interventions	Drug: Avatrombopag
Sponsor/Collaborators	Swedish Orphan Biovitrum - CRO: Syneos Health Italy S.r.l.
Gender	All
Age	18 Years and older (Adult, Older Adult)
Phases
Enrollment	150 participants
Study Type	Observational
Study Designs	Cohort
Start Date	22/02/2022
Completion Date	01/05/2025
Locations	A.O.U. Policlinico P. Giaccone di Palermo, Prof.^ssa Mariasanta Napolitano, U.O.C. di Ematologia
URL	https://www.clinicaltrials.gov/ct2/show/NCT04943042

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	30/04/2025
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

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 218672
Conditions	Nonalcoholic steatohepatitis (NASH) Steatoepatite pre-cirrotica non alcolica (NASH)
Interventions
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	25/02/2025
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

Study Title	Levels of Inflammation in People With Cardiovascular Disease (POSEIDON)
NCT Number	NCT06122961 Other IDs: NN6018-7527\|U1111-1286-3420
Conditions	Cardiovascular Risk\|Heart Failure\|Chronic Kidney Disease
Interventions	OTHER: No treatment given
Sponsor	Novo Nordisk A/S
Gender	ALL
Age	ADULT, OLDER_ADULT
Phases
Enrollment	21504
Study Type	OBSERVATIONAL
Study Design	Observational Model: \|Time Perspective: p
Start Date	23/11/2023
Completion Date	17/02/2025
Locations	A.O.U. Policlinico Giaccone, Palermo, 90127, Italy\|
Study URL	https://clinicaltrials.gov/study/NCT06122961

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	14/02/2025
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

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	01/02/2025
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

Title	Integrated Multiomics and Multilevel Characterization of Haematological Disorders and Malignancies
NCT Number	NCT04298892
Conditions	Intervention/treatment Haematologic Disease Haematological Malignancy Other: clinical data and sample collection
Interventions
Sponsor	Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Gender	All
Age	18 Years and older (Adult, Older Adult)
Phases
Enrollment	2000 participants
Study Type	Observational [Patient Registry]
Study Designs	Cohort
Start Date	07/01/2020
Completion Date	01/02/2025
Locations	A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa
URL	https://www.clinicaltrials.gov/ct2/show/NCT04298892

Title	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Dose Phase 2 Study to Evaluate the Efficacy and Safety of BMS-986263 in Adults with Compensated Cirrhosis from Nonalcoholic Steatohepatitis (NASH) Studio di Fase 2, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli, a dosi multiple per valutare l’efficacia e la sicurezza di BMS-986263 in soggetti adulti con cirrosi compensata dovuta a steatoepatite non alcolica (NASH)
EudraCT number	2019-003932-22
Conditions	Compensated Cirrhosis from Nonalcoholic Steatohepatitis (NASH) Cirrosi compensata dovuta a steatoepatite non alcolica (NASH)
Interventions
Sponsor/Collaborators	BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
Gender	Female; Male
Age	Adults; Elderly;
Phases	Phase II
Enrollment	270
Study Type	Therapeutic exploratory (Phase II)
Study Design	Controlled; Randomised; Parallel group;
Start Date	26/04/2021
Completion Date	20/01/2025
Locations	A.O.U. Policlinico P. Giaccone Palermo, PRof. Petta Salvatore
URL	https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-003932-22/IT

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	08/01/2024
Completion Date	12/01/2025
Locations	Policlinico "P. Giaccone", Palermo, Italy\|
Study URL	https://clinicaltrials.gov/study/NCT05936580

Study Title	A Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
NCT Number	NCT04442022 Other IDs: XPORT-DLBCL-030\|2020-000605-84
Conditions	Relapsed/Refractory Diffuse Large B-cell Lymphoma
Interventions	DRUG: Selinexor (combination therapy)\|DRUG: Selinexor (combination therapy)\|DRUG: Selinexor (combination therapy)\|DRUG: Placebo matching for Selinexor (combination therapy)\|DRUG: Rituximab (combination therapy)\|DRUG: Rituximab (combination therapy)\|DRUG: Gemcitabine (combination therapy)\|DRUG: Dexamethasone (combination therapy)\|DRUG: Cisplatin (combination therapy)\|DRUG: Selinexor (continuous therapy)\|DRUG: Placebo matching for Selinexor (continuous therapy)
Sponsor	Karyopharm Therapeutics Inc
Gender	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE2\|PHASE3
Enrollment	501
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: SEQUENTIAL\|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)\|Primary Purpose: TREATMENT
Start Date	09/03/2020
Completion Date	12/01/2025
Locations	Ospedali Riuniti "Villa Sofia-Cervello", Palermo, Italy\| U.O. di Ematologia con trapianto - Centro di Riferimento Regionale per le coagulopatie rare nel bambino e nell'adulto Dipart. Biomedico di Medicina Interna - A.U. Policlinico "Paolo Giaccone", Palermo, Italy\|
Study URL	https://clinicaltrials.gov/study/NCT04442022

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	09/01/2025
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	AML Patients Bearing FLT3 Mutations Based on Peripheral Blast Clearance
NCT Number	NCT04174612 Other IDs: AML1919
Conditions	Acute Myeloid Leukemia With FLT3/ITD Mutation
Interventions	DRUG: Cytarabine\|DRUG: Daunorubicin\|DRUG: Midostaurin\|DRUG: Cytarabine HD
Sponsor	Gruppo Italiano Malattie EMatologiche dell'Adulto
Gender	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE3
Enrollment	172
Study Type	INTERVENTIONAL
Study Design	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: NONE\|Primary Purpose: TREATMENT
Start Date	24/04/2020
Completion Date	08/01/2025
Locations	Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo, Palermo, Italy\| dott.^ssa Maria Enza Mitra, Ematologia, Dir. Prof. Sergio Mario Siragusa, Aou Policlinico P. Giaccone - Palermo - UO Ematologia, Palermo, Italy\|
Study URL	https://clinicaltrials.gov/study/NCT04174612

Study Title	Ofatumumab & Ibrutinib + Allogeneic Bone Marrow Transplant or Consolidation in High Risk Chronic Lymphocytic Leukemia
NCT Number	NCT02388048 Othr ID: LLC1215\|2015-000684-13
Conditions	Leukemia, Lymphoblastic, Chronic
Interventions	DRUG: Ibrutinib + ofatumumab
Sponsor	Gruppo Italiano Malattie EMatologiche dell'Adulto - Collaborators:
Gender	ALL
Age	ADULT, OLDER_ADULT
Phases	PHASE2
Enrollment	19
Study Type	INTERVENTIONAL
Study Design	Allocation: NA\|Intervention Model: SINGLE_GROUP\|Masking: NONE\|Primary Purpose: TREATMENT
Start Date	10/01/2015
Completion Date	08/01/2025
Locations	U.O. di Ematologia con trapianto - Centro di Riferimento Regionale per le coagulopatie rare nel bambino e nell'adulto Dipart. Biomedico di Medicina Interna - A.U. Policlinico "Paolo Giaccone", Palermo, Italy\|
Study URL	https://clinicaltrials.gov/study/NCT02388048

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	06/01/2025
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