Trial in corso
Ascolta
[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: 121] - [ultimo aggiornamento: 25/11/2024]
| 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 6400795MMY3006 |
| Medical condition | Multiple myeloma Mieloma multiplo |
| Interventions | |
| Sponsor | JANSSEN CILAG INTERNATIONAL NV |
| Gender | Female; Male |
| Population Age | Adults; Elderly; |
| Phases | Phase III |
| Enrollment | 590 |
| Trial type | Therapeutic confirmatory (Phase III) |
| Design of the trial | 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 |
| 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 |
| Sex | 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 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 |
| Sex | 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 |
| Sex | 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 |
| 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 | Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH) |
| NCT Number | NCT04822181 Other IDs: NN9931-4553|U1111-1244-3678|2019-004594-44|jRCT2031210033 |
| Conditions | Non-alcoholic Steatohepatitis |
| Interventions | DRUG: Semaglutide|DRUG: Placebo |
| Sponsor | Novo Nordisk A/S |
| Sex | 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 |
| 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 |
| Medical condition | Non-alcoholic Steatohepatitis (NASH) Steatoepatite non alcolica (NASH) |
| Interventions | |
| Sponsor/Collaborators | INVENTIVA S.A. |
| Gender | Female; Male |
| Population Age | Adults; Elderly; |
| Phases | Phase III |
| Enrollment | 2000 |
| Trial type | Therapeutic confirmatory (Phase III) |
| Design of the trial | 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 Other IDs: CLIN-60190-454|2023-505251-43-00 |
| Conditions | Primary Biliary Cholangitis (PBC) |
| Interventions | DRUG: Elafibranor|OTHER: Matched 80 mg placebo |
| Sponsor | Ipsen |
| Sex | 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 |
| Population Age | Adults; Elderly; |
| Phases | Phase II |
| Enrollment | 22 |
| Trial type | Therapeutic exploratory (Phase II) |
| Design of the trial | |
| 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 |
| Sex | 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 |
| Sex | 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 |
| Sex | 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) |
| Sex | 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 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 |
| 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 |
| 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 |
| Sex | 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 | 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 |
| Sex | 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 |
| Conditions | Nonalcoholic Steatohepatitis (NASH) |
| Interventions | DRUG: BMS-986263|OTHER: Placebo |
| Sponsor | Bristol-Myers Squibb |
| Gender | |
| Age | |
| 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 | 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 |
| Medical condition | 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 |
| Population Age | Adults; Elderly; |
| Phases | Phase II |
| Enrollment | 120 |
| Trial type | Therapeutic exploratory (Phase II) |
| Design of the trial | 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 |
| 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 |
| Medical condition | Chronic Hepatitis B infection Infezione cronica da Epatite B |
| Interventions | |
| Sponsor/Collaborators | GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT |
| Gender | Female; Male |
| Population Age | Adults; Elderly; |
| Phases | Phase III |
| Enrollment | 534 |
| Trial type | Therapeutic confirmatory (Phase III) |
| Design of the trial | 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 |
| Sex | 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 |
| Sex | 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 |
| Sex | 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 | 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 |
| Sex | 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 |
| Sex | 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 |
| Sex | 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 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 | Galapagos NV |
| Sex | 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 | 04/05/2023 |
| Completion Date | 07/01/2026 |
| Locations | Prof.ssa Giuliana Guggino, Reumatologia, Policlinico Paolo Giaccone, Palermo, 90127, Italy| |
| Study URL | https://clinicaltrials.gov/study/NCT05785611 |
| 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 |
| Sex | 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 |
| Sex | 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 |
| Sex | 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 |
| Medical condition | Thyroid Eye Disease (TED) Oftalmopatia tiroidea (TED) attiva |
| Interventions | |
| Sponsor/Collaborators | Immunovant Sciences GmbH |
| Gender | Female; Male |
| Population Age | Adults; Elderly; |
| Phases | Phase III |
| Enrollment | 100 |
| Trial type | Therapeutic confirmatory (Phase III) |
| Design of the trial | 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 |
| Medical condition | Non-cirrhotic non-alcoholic steatohepatitis with fibrosis Steatoepatite non alcolica non cirrotica con fibrosi |
| Interventions | |
| Sponsor/Collaborators | ASTRAZENECA AB |
| Gender | Female; Male |
| Population Age | Adults; Elderly; |
| Phases | Phase II |
| Enrollment | 318 |
| Trial type | Therapeutic exploratory (Phase II) |
| Design of the trial | 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 |
| Medical condition | 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 |
| Population Age | Adults; Elderly; |
| Phases | Phase III |
| Enrollment | 6200 |
| Trial type | Therapeutic confirmatory (Phase III) |
| Design of the trial | 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 |
| Medical condition | Thyroid Eye Disease (TED) Oftalmopatia tiroidea (TED) |
| Interventions | |
| Sponsor/Collaborators | Immunovant Sciences GmbH |
| Gender | Female; Male |
| Population Age | Adults; Elderly; |
| Phases | Phase III |
| Enrollment | 180 |
| Trial type | Therapeutic confirmatory (Phase III) |
| Design of the trial | |
| 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 |
| Medical condition | Nonalcoholic steatohepatitis (NASH) Steatoepatite pre-cirrotica non alcolica (NASH) |
| Interventions | |
| Sponsor/Collaborators | GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT |
| Gender | Female; Male |
| Population Age | Adults; Elderly; |
| Phases | Phase II |
| Enrollment | 246 |
| Trial type | Therapeutic exploratory (Phase II) |
| Design of the trial | 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 |
| Sex | 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 |
| Medical condition | 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 |
| Population Age | Adults; Elderly; |
| Phases | Phase II |
| Enrollment | 270 |
| Trial type | Therapeutic exploratory (Phase II) |
| Design of the trial | Controlled; Randomised; Parallel group; |
| Start Date | 26/04/2021 |
| Completion Date | 20/01/2025 |
| Locations | Belgium - A.O.U. Policlinico P. Giaccone Palermo, 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 |
| Sex | 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 |
| Sex | 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 |
| Sex | 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 |
| Sex | 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: |
| Sex | 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 |
| Sex | 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 |
| 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 | 31/12/2024 |
| 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 |
| Title | Efficacy and Tolerability of a Composition Comprising of HMO in a Supplement Format on Colic Management: a Double-blind, Randomized, Placebo-controlled Trial |
| NCT Number | NCT05554991 20.28.INF |
| Conditions | Colic |
| Interventions | Dietary Supplement: HMO Dietary Supplement: Placebo Behavioral: Parental reassurance and support |
| Sponsor | Société des Produits Nestlé (SPN) |
| Gender | All |
| Age | 2 Weeks to 12 Weeks (Child) |
| Phases | |
| Enrollment | 144 participants |
| Study Type | Interventional (Clinical Trial) |
| Study Designs | Parallel Assignment |
| Start Date | 24/06/2022 |
| Completion Date | 31/12/2024 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. Neonatologia e Nido, prof. Mario Giuffrè |
| URL | https://www.clinicaltrials.gov/ct2/show/NCT05554991 |
| Title | Impact of Extra Virgin Olive Oil (EVOO) With Health Properties in Improving the Overall Health Status and Preventing Cardiovascular Risk in Metabolic Syndrome |
| NCT Number | NCT05282316 |
| Conditions | Metabolic Syndrome |
| Interventions | Dietary Supplement: EVOO polyphenols enriched Dietary Supplement: EVOO standard |
| Sponsor | University of Palermo |
| Gender | All |
| Age | 18 Years and older (Adult, Older Adult) |
| Phases | Phase 3 |
| Enrollment | 90 |
| Study Type | Interventional |
| Study Designs | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Double-blind placebo-controlled Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Masking Description: Same organoleptic features of the two different kind of EVOO (polyphenols enriched and standard). Primary Purpose: Prevention |
| Start Date | 18/02/2022 |
| Completion Date | 31/12/2024 |
| Locations | Italy Department of Internal Medicine, University Hospital of Palermo Recruiting Palermo, Italy, 90127 Contact: Aurelio Seidita, MD +390916554710 aurelio.seidita@unipa.it Contact: Maurizio Soresi, MD +390916554710 maurizio.soresi@unipa.it Sub-Investigator: Lydia Giannitrapani, MD |
| URL | https://ClinicalTrials.gov/show/NCT05282316 |
| Title | A Multicentre, Prospective, Non-Interventional, Single-Arm Study Investigating Glycaemic Control and Patient-Reported Outcomes in Type 2 Diabetes Patients, Uncontrolled on DPP4i Treatment and Who Switch to Oral Semaglutide in a Real-World Setting in Italy |
| NCT Number | NCT05755360 NN9924-7508 U1111-1274-4674 ( Other Identifier ) (OTHER: World Health Organization (WHO)) |
| Conditions | Intervention/treatment Diabetes Mellitus, Type 2 Drug: Semaglutide |
| Interventions | |
| Sponsor/Collaborators | Novo Nordisk A/S |
| Gender | All |
| Age | 18 Years and older (Adult, Older Adult) |
| Phases | |
| Enrollment | 390 participants |
| Study Type | Observational |
| Study Designs | Cohort |
| Start Date | 21/02/2023 |
| Completion Date | 31/10/2024 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo, Prof. Mario Barbagallo, U.O.C. di Geriatria |
| URL | https://www.clinicaltrials.gov/ct2/show/NCT05755360 |
| Study Title | A Study to Test Whether Two Different Doses of BI 685509 Help People With Liver Cirrhosis and High Blood Pressure in the Portal Vein (Main Vessel Going to the Liver) |
| NCT Number | NCT05161481 Other IDs: 1366-0021|2021-001285-38 |
| Conditions | Hypertension, Portal |
| Interventions | DRUG: BI 685509|DRUG: Placebo matching BI 685509 |
| Sponsor | Boehringer Ingelheim |
| Sex | ALL |
| Age | ADULT, OLDER_ADULT |
| Phases | PHASE2 |
| Enrollment | 78 |
| Study Type | INTERVENTIONAL |
| Study Design | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date | 02/03/2022 |
| Completion Date | 24/10/2024 |
| Locations | prof.ssa Vincenza Calvaruso, , U.O.C. Gastroenterologia, A.O. Univ. Policlinico "Paolo Giaccone", Palermo, 90127, Italy| |
| Study URL | https://clinicaltrials.gov/study/NCT05161481 |
| Study Title | A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes |
| NCT Number | NCT04255433 Other IDs: 17073|I8F-MC-GPGN|2019-002735-28 |
| Conditions | Type 2 Diabetes Mellitus |
| Interventions | DRUG: Tirzepatide|DRUG: Dulaglutide |
| Sponsor | Eli Lilly and Company |
| Sex | ALL |
| Age | ADULT, OLDER_ADULT |
| Phases | PHASE3 |
| Enrollment | 13299 |
| Study Type | INTERVENTIONAL |
| Study Design | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date | 29/05/2020 |
| Completion Date | 17/10/2024 |
| Locations | U.O.C. Malattie Endocrine, del Ricambio e della Nutrizione, prof.ssa Carla Giordano, A.O.U. Policlinico Paolo Giaccone, Palermo, Sicilia, 90129, Italy |
| Study URL | https://clinicaltrials.gov/study/NCT04255433 |
| Study Title | Study to Evaluate the Efficacy and Safety of HepaStem in Patients With Acute on Chronic Liver Failure (ACLF) |
| NCT Number | NCT04229901 Other IDs: HEP102 |
| Conditions | Acute on Chronic Liver Failure |
| Interventions | DRUG: HepaStem|DRUG: Placebo |
| Sponsor | Cellaion SA |
| Sex | ALL |
| Age | ADULT, OLDER_ADULT |
| Phases | PHASE2 |
| Enrollment | 133 |
| Study Type | INTERVENTIONAL |
| Study Design | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date | 21/01/2020 |
| Completion Date | 05/10/2024 |
| Locations | prof.ssa Vincenza Calvaruso, U.O.C. Gastroenterologia, Azienda Ospedaliera Universitaria Policlinico, Palermo, 90127, Italy |
| Study URL | https://clinicaltrials.gov/study/NCT04229901 |
| Study Title | A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH) |
| NCT Number | NCT04166773 Other IDs: 17361|I8F-MC-GPHR|2019-001550-26 |
| Conditions | Nonalcoholic Steatohepatitis |
| Interventions | DRUG: Tirzepatide|DRUG: Placebo |
| Sponsor | Eli Lilly and Company |
| Sex | ALL |
| Age | ADULT, OLDER_ADULT |
| Phases | PHASE2 |
| Enrollment | 196 |
| Study Type | INTERVENTIONAL |
| Study Design | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date | 19/11/2019 |
| Completion Date | 01/10/2024 |
| Locations | Prof. Salvatore Petta, U.O.C. di Gastroenterologia, A.O.U. Policlinico Paolo Giaccone, Palermo, Sicilia, 90127, Italy |
| Study URL | https://clinicaltrials.gov/study/NCT04166773 |
| Title | An Open-Label Study in Adolescent and Adult Severe (Coagulation Factor Activity <1%) Hemophilia A or B Patients With or Without Inhibitors Comparing Standard Treatment to PF-06741086 Prophylaxis Studio in aperto in pazienti adolescenti e adulti affetti da grave emofilia A o B (attività del fattore di coagulazione <1%) con o senza inibitori volto a confrontare la terapia standard con la profilassi con PF-06741086 |
| EudraCT number | 2018-003660-31 NCT03938792 |
| Conditions | Hemophilia A or B Emofilia A o B |
| Interventions | |
| Sponsor | PFIZER INC |
| Gender | Male |
| Age | Adolescents (12-17 years); Adults; Elderly; |
| Phases | Phase III |
| Enrollment | 145 |
| Study Type | Therapeutic confirmatory (Phase III) |
| Study Designs | Controlled; Open; Unidirezionale One way |
| Start Date | 24/09/2020 |
| Completion Date | 27/09/2024 |
| Locations | United States - A.O.U. Policlinico P. Giaccone Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa |
| URL | https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-003660-31/IT https://www.clinicaltrials.gov/ct2/show/NCT03938792 |
| 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 | The BASA Study: Breath Analysis for Severe Asthma Patients. A New, Non-invasive Approach for the Monitoring of Inflammation in Severe Asthma Patients on Biologics |
| NCT Number | NCT05946421 |
| Conditions | Intervention/treatment Severe Asthma |
| Interventions | Device: exhaled breath analysis |
| Sponsor | |
| Gender | All |
| Age | 18 Years and older (Adult, Older Adult) |
| Phases | |
| Enrollment | 100 participants |
| Study Type | Observational |
| Study Designs | Cohort |
| Start Date | 04/07/2023 |
| Completion Date | 04/09/2024 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo, Nicola Scichilone, Stefania Principe, Carmen Durante |
| URL | https://www.clinicaltrials.gov/ct2/show/NCT05946421 |
| Study Title | A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease |
| NCT Number | NCT03819153 Other IDs: NN9535-4321|U1111-1217-6259|2018-002878-50|JapicCTI-194843 |
| Conditions | Diabetes Mellitus, Type 2 |
| Interventions | DRUG: Semaglutide|DRUG: Placebo (semaglutide) |
| Sponsor | Novo Nordisk A/S |
| Sex | ALL |
| Age | ADULT, OLDER_ADULT |
| Phases | PHASE3 |
| Enrollment | 3508 |
| Study Type | INTERVENTIONAL |
| Study Design | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date | 17/06/2019 |
| Completion Date | 01/09/2024 |
| Locations | AOU Pol.Giaccone, U.O.C. Malattie Endocrine, del Ricambio e della Nutrizione, prof.ssa Carla Giordano, Palermo, PA, 90127, Italy| |
| Study URL | https://clinicaltrials.gov/study/NCT03819153 |
| Title | Copanlisib in combination with Rituximab-Bendamustine in patients with Relapsed-Refractory Diffuse Large B-cell Lymphoma: a multicentric Phase II trial Copanlisib in combinazione con Rituximab e Bendamustina per il trattamento di pazienti con Linfoma Diffuso a Grandi Cellule B ricaduto o refrattario: studio multicentrico di fase II |
| EudraCT number | 2019-004898-63 FIL COPA RB |
| Conditions | Patients with Relapsed-Refractory Diffuse Large B-cell Lymphoma Pazienti con Linfoma Diffuso a Grandi Cellule B ricaduto o refrattario |
| Interventions | |
| Sponsor | FONDAZIONE ITALIANA LINFOMI ONLUS |
| Gender | Female; Male |
| Age | Adults; Elderly; |
| Phases | Phase II |
| Enrollment | 81 |
| Study Type | Therapeutic exploratory (Phase II) |
| Study Designs | Studio di fase II, braccio singolo, in aperto Phase II, single arm, open label clinical trial |
| Start Date | 18/08/2020 |
| Completion Date | 17/08/2024 |
| 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/2019-004898-63/IT |
| Title | A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Lenvatinib in First-line Therapy of Participants With Advanced Hepatocellular Carcinoma (LEAP-002) |
| NCT Number | NCT03713593 MK 7902-002 |
| Conditions | Carcinoma, Hepatocellular |
| Interventions | |
| Sponsor | Merck Sharp & Dohme LLC |
| Gender | All |
| Age | 18 Years and older (Adult, Older Adult) |
| Phases | Phase 3 |
| Enrollment | |
| Study Type | Interventional (Clinical Trial) |
| Study Designs | Parallel Assignment |
| Start Date | 31/12/2018 |
| Completion Date | 29/08/2024 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. Gastro-enterologia, Prof. Antonio Craxì |
| URL | https://www.clinicaltrials.gov/ct2/show/NCT03713593 |
| Title | Semaglutide Cardiovascular Outcomes Trial in Patients With Type 2 Diabetes |
| NCT Number | NCT03914326 EX9924-4473 2018-003141-42 ( Registry Identifier: European Medicines Agency (EudraCT) ) U1111-1218-5368 ( Other Identifier: World Health Organization (WHO) ) |
| Conditions | Diabetes Mellitus, Type 2 |
| Interventions | Parallel Assignment |
| Sponsor | Novo Nordisk A/S |
| Gender | All |
| Age | 50 Years and older (Adult, Older Adult) |
| Phases | Phase 3 |
| Enrollment | 9642 participants |
| Study Type | Interventional (Clinical Trial) |
| Study Designs | Allocation: Randomized | Intervention Model: Parallel Assignment | Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) | Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures |
| Start Date | 17/06/2019 |
| Completion Date | 29/07/2024 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo |
| URL | https://clinicaltrials.gov/ct2/show/NCT03914326 |
| 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 | 30/06/2024 |
| 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 | A Study to Test Whether Different Doses of BI 1291583 Help People With Bronchiectasis |
| NCT Number | NCT05238675 Other IDs: 1397-0012|2021-003304-41 |
| Conditions | Bronchiectasis |
| Interventions | DRUG: BI 1291583|DRUG: Placebo |
| Sponsor | Boehringer Ingelheim |
| Sex | ALL |
| Age | ADULT, OLDER_ADULT |
| Phases | PHASE2 |
| Enrollment | 240 |
| Study Type | INTERVENTIONAL |
| Study Design | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date | 21/03/2022 |
| Completion Date | 13/06/2024 |
| Locations | Prof. Salvatore Battaglia, Pneumologia, Dir. Prof. Nicola Scichilone, A.O. Univ. Policlinico "Paolo Giaccone", Palermo, 90127, Italy| |
| Study URL | https://clinicaltrials.gov/study/NCT05238675 |
| Title | Phase III Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of the Addition of Crenolanib to Salvage Chemotherapy Versus Salvage Chemotherapy Alone in Subjects <= 75 Years of Age with Relapsed/Refractory FLT3 Mutated Acute Myeloid Leukemia |
| EudraCT Number | 2017-001600-29 |
| Conditions | Relapsed/Refractory FLT3 Mutated Acute Myeloid Leukemia (AML) |
| Interventions | |
| Sponsor Name | Arog Pharmaceuticals, Inc. |
| Gender | Male, Female |
| Age | Adults, Elderly |
| Phases | III |
| Enrollment | 322 |
| Study Type | Therapeutic confirmatory (Phase III) |
| Study Designs | Controlled; Randomised; Double blind; Parallel group |
| Start Date | 13/06/2018 |
| Completion Date | 11/06/2024 |
| Locations | U.O.C. di Ematologia, AOUP P. Giaccone, Palermo, Prof. Sergio Siragusa |
| URL | https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-001600-29/IT |
| Title | A Phase 3, Randomized, Placebo-controlled, Observer-blind, Multi-country Study to Demonstrate the Efficacy of a Single Dose and Annual Revaccination Doses of GSK's RSVPreF3 OA Investigational Vaccine in Adults Aged 60 Years and Above |
| NCT Number | NCT04886596 212494 2020-000753-28 ( EudraCT Number ) |
| Conditions | Respiratory Syncytial Virus Infections |
| Interventions | Parallel Assignment |
| Sponsor | GlaxoSmithKline |
| Gender | All |
| Age | 60 Years and older (Adult, Older Adult) |
| Phases | |
| Enrollment | 5000 |
| Study Type | Interventional (Clinical Trial) |
| Study Designs | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Masking Description: This is an observer blind study. |
| Start Date | 25/05/2021 |
| Completion Date | 31/05/2024 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo |
| URL | https://clinicaltrials.gov/ct2/show/NCT04886596 |
| Study Title | Effect of AIRVO Heated Humidification in Bronchiectasis |
| NCT Number | NCT04102774 Other IDs: AIRVO-BX |
| Conditions | Bronchiectasis Adult |
| Interventions | DEVICE: Over-night treatment with myAIRVO2 |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico - Collaborators: Azienda Ospedaliera San Gerardo di Monza|ASST Fatebenefratelli Sacco|Fondazione IRCCS Policlinico San Matteo di Pavia|Ospedale Maggiore Di Trieste|Azienda Ospedaliero-Universitaria di Modena|Fondazione Policlinico Universitario Agostino Gemelli IRCCS|Fondazione Salvatore Maugeri|Università degli Studi di Ferrara|Azienda Ospedaliero, Universitaria Pisana|IRCCS Azienda Ospedaliero-Universitaria di Bologna|Ospedale San Paolo|Universita degli Studi di Catania|Azienda Ospedaliera di Padova|University of Palermo|Azienda Ospedaliero-Universitaria di Parma|University of Foggia|Monaldi Hospital|Fondazione Don Carlo Gnocchi Onlus|Ospedale San Donato |
| Sex | ALL |
| Age | ADULT, OLDER_ADULT |
| Phases | NA |
| Enrollment | 130 |
| Study Type | INTERVENTIONAL |
| Study Design | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date | 20/06/2019 |
| Completion Date | 31/05/2024 |
| Locations | Dipartimento Biomedico di Medicina Interna e Specialistica, Università degli Studi di Palermo, Palermo, Italy| |
| Study URL | https://clinicaltrials.gov/study/NCT04102774 |
| Title | Effects of Liraglutide on Glycemic Control, Markers of Inflammation and Endothelial Dysfunction Compared to Scheme Insulin Basal Bolus, in a Population of Diabetic Inpatients and Possible Correlation With Intra-hospital Mortality Rates |
| NCT Number | NCT05360537 U Palermo |
| Conditions | Diabetes Mellitus, Type 2 |
| Interventions | Parallel Assignment |
| Sponsor | Antonino Tuttolomondo, University professor of Palermo |
| Gender | All |
| Age | 18 Years to 90 Years (Adult, Older Adult) |
| Phases | Phase 4 |
| Enrollment | 5000 |
| Study Type | Interventional (Clinical Trial) |
| Study Designs | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Parallel Assignment Masking: Double (Participant, Care Provider) |
| Start Date | 01/04/2021 |
| Completion Date | 31/05/2024 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo |
| URL | https://clinicaltrials.gov/ct2/show/NCT05360537 |
| Study Title | A Study of Oral Upadacitinib Tablets to Assess Treatment Patterns, Achievement of Treatment Targets and Maintenance of Response in Adult Participants With Moderate to Severe Rheumatoid Arthritis |
| NCT Number | NCT04497597 Other IDs: P20-095 |
| Conditions | Rheumatoid Arthritis (RA) |
| Interventions | |
| Sponsor | AbbVie |
| Sex | |
| Age | ADULT, OLDER_ADULT |
| Phases | |
| Enrollment | 1532 |
| Study Type | OBSERVATIONAL |
| Study Design | Observational Model: |Time Perspective: p |
| Start Date | 16/10/2020 |
| Completion Date | 15/05/2024 |
| Locations | Azienda Ospedaliera Civico Di Cristina Benfratelli- P.O. Civico /ID# 228912, Palermo, 90127, Italy | Prof.ssa Giuliana Guggino, Reumatologia, Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 228160, Palermo, 90127, Italy| |
| Study URL | https://clinicaltrials.gov/study/NCT04497597 |
| Title |
A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogrens Syndrome (pSS) Studio multicentrico, randomizzato, controllato con placebo, in doppio cieco per valutare l’efficacia e la sicurezza di nipocalimab in adulti affetti da sindrome di Sjogrens primaria (SSp) |
| EudraCT number | 2021-000665-32 |
| Conditions | Primary Sjogrens Syndrome sindrome di Sjogrens primaria |
| Interventions | |
| Sponsor | JANSSEN CILAG INTERNATIONAL NV |
| Gender | Female; Male |
| Age | Adults; Elderly; |
| Phases | Phase II |
| Enrollment | 150 |
| Study Type | Therapeutic exploratory (Phase II) |
| Study Designs | Controlled; Randomised; Parallel group; |
| Start Date | 11/10/2021 |
| Completion Date | 08/05/2024 |
| Locations | Italy - A.O.U. Policlinico P. Giaccone Palermo |
| URL | https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-000665-32/IT |
| Study Title | Study to Assess Efficacy and Safety of NS-018 Compared to BAT in Patients With Myelofibrosis |
| NCT Number | NCT04854096 Other IDs: NS-018-201 |
| Conditions | Primary Myelofibrosis|Post-essential Thrombocythemia Myelofibrosis|Post-polycythemia Vera Myelofibrosis |
| Interventions | DRUG: NS-018|DRUG: Best Available Therapy |
| Sponsor | NS Pharma, Inc. - Collaborators: Nippon Shinyaku Co., Ltd. |
| Sex | ALL |
| Age | ADULT, OLDER_ADULT |
| Phases | PHASE2 |
| Enrollment | 120 |
| Study Type | INTERVENTIONAL |
| Study Design | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date | 31/01/2023 |
| Completion Date | 24/04/2024 |
| Locations | Polycytemia Vera Unit, Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone, Palermo, 90127, Italy| |
| Study URL | https://clinicaltrials.gov/study/NCT04854096 |
| Title | Reparixin 1200 mg TID as add-on to SoC to Limit Disease Progression in Hospitalised Patients With COVID-19 and Other Community-Acquired Pneumonia. A Multicentre, Randomised, Double-blinded, Placebo-controlled, Phase III Trial (REPAVID-22) |
| NCT Number | NCT05254990 |
| Conditions | Infectious Pneumonia Severe COVID-19 |
| Interventions | Parallel Assignment |
| Sponsor | Dompé Farmaceutici S.p.A. |
| Gender | All |
| Age | 18 Years and older (Adult, Older Adult) |
| Phases | Phase 3 |
| Enrollment | 526 participants |
| Study Type | Interventional (Clinical Trial) |
| Study Designs | Allocation: Randomized | Intervention Model: Parallel Assignment | Intervention Model Description: male and female patients >18 years, hospitalised for COVID-19, will be assigned (1:1) to receive either oral reparixin (treatment group) or matched placebo (control group) three times a day (TID) for up to 21 days. | Masking: Triple (Participant, Care Provider, Investigator) |
| Start Date | 06/04/2022 |
| Completion Date | 01/03/2024 |
| Locations | Sperimentatore: Prof. N. Scichilone Centro: U.O.C. di Pneumologia |
| URL | https://clinicaltrials.gov/ct2/show/NCT05254990 |
| Title | Prospective Randomized Study on the Feasibility of Allogeneic Stem Cell Transplantation in Higher-risk-myelodysplastic Syndromes, Performed Upfront or Preceded by Azacitidine or Conventional Chemotherapy According to the BM-blast Proportion |
| NCT Number | NCT04184505 MDS 0519 Codice Eudract: 2019-003997-25 |
| Conditions | High-risk MDS |
| Interventions | Parallel Assignment |
| Sponsor | Gruppo Italiano Malattie EMatologiche dell'Adulto |
| Gender | All |
| Age | 18 Years to 70 Years (Adult, Older Adult) |
| Phases | Phase 3 |
| Enrollment | 274 participants |
| Study Type | Interventional (Clinical Trial) |
| Study Designs | Allocation: Randomized | Intervention Model: Parallel Assignment | Masking: None (Open Label) | Primary Purpose: Treatment |
| Start Date | 27/11/2020 |
| Completion Date | 01/03/2024 |
| Locations | Sperimentatore: Prof. S. Siragusa Centro: U.O.C. di Ematologia Sponsor: Fondazione GIMEMA Franco Mandelli Onlus |
| URL | https://clinicaltrials.gov/ct2/show/NCT04184505 |
| Title | A Retrospective and Prospective Multicentre Observational Study for the Evaluation of Incidence of Familial AML/MDSs in Patients With Myeloid Neoplasms (AML/MDS) |
| NCT Number | NCT04460950 AML2120 |
| Conditions | Acute Myeloid Leukemia Familial Acute Myeloid Leukemia Myelodysplastic Syndromes |
| Interventions | |
| Sponsor | Gruppo Italiano Malattie EMatologiche dell'Adulto |
| Gender | All |
| Age | 18 Years and older (Adult, Older Adult) |
| Phases | |
| Enrollment | 237 participants |
| Study Type | Observational |
| Study Designs | Case-Only |
| Start Date | 16/12/2020 |
| Completion Date | 31/03/2024 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa, Dott.ssa Mitra |
| URL | https://www.clinicaltrials.gov/ct2/show/NCT04460950 |
| Title | Prospective randomized study on the feasibility of allogeneic stem cell transplantation in higher-risk-myelodysplastic syndromes, performed upfront or preceded by azacitidine or conventional chemotherapy, according to the BM-blast proportion (ACROBAT trial) Studio randomizzato, prospettico, sulla fattibilità del trapianto allogenico di cellule staminali in pazienti affetti da Sindrome mielodisplastica ad alto rischio, eseguito upfront o preceduto da azacitidina o chemioterapia convenzionale, secondo la percentuale di blasti midollari |
| EudraCT number | 2019-003997-25 NCT04184505 |
| Conditions | Higher-risk-myelodysplastic syndromes Sindrome mielodisplastica ad alto rischio |
| Interventions | |
| Sponsor | FONDAZIONE GIMEMA (GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL' ADULTO) FRANCO MANDELLI ONLUS |
| Gender | Female; Male |
| Age | Adults; Elderly; |
| Phases | Phase III |
| Enrollment | 274 |
| Study Type | Therapeutic confirmatory (Phase III) |
| Study Designs | Controlled; Randomised; Open; Parallel group; |
| Start Date | 06/10/2020 |
| Completion Date | 01/03/2024 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa |
| URL | https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-003997-25/IT https://www.clinicaltrials.gov/ct2/show/NCT04184505 |
| Title | Epidemiology of COVID-19 Infection in Patients With Hematological Malignancies: A European Haematology Association Survey |
| NCT Number | NCT04733729 |
| Conditions | COVID-19 Infection in Hematological Malignancies Patients |
| Interventions | |
| Sponsor | LIVIO PAGANO, Catholic University of the Sacred Heart |
| Gender | All |
| Age | 18 Years to 99 Years (Adult, Older Adult) |
| Phases | |
| Enrollment | 3000 participants |
| Study Type | Observational [Patient Registry] |
| Study Designs | Cohort |
| Start Date | 01/03/2020 |
| Completion Date | 31/03/2024 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa, Dott.ssa Mitra |
| URL | https://www.clinicaltrials.gov/ct2/show/NCT04733729 |
| Title | AN INTERVENTIONAL, EFFICACY AND SAFETY, PHASE 2, RANDOMIZED, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE A REPEAT 5-DAY COURSE OF NIRMATRELVIR/RITONAVIR COMPARED TO PLACEBO/RITONAVIR IN PARTICIPANTS AT LEAST 12 YEARS OF AGE WITH REBOUND OF COVID-19 SYMPTOMS AND RAPID ANTIGEN TEST POSITIVITY |
| NCT Number | NCT05567952 C4671042 2022-002827-36 ( EudraCT Number ) |
| Conditions | COVID-19 |
| Interventions | Drug: nirmatrelvir Drug: ritonavir Drug: placebo for nirmatrelvir |
| Sponsor | Pfizer |
| Gender | All |
| Age | 12 Years and older (Child, Adult, Older Adult) |
| Phases | Phase 2 |
| Enrollment | 436 |
| Study Type | Interventional (Clinical Trial) |
| Study Designs | Parallel Assignment |
| Start Date | 19/10/2022 |
| Completion Date | 15/02/2024 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo |
| URL | https://www.clinicaltrials.gov/ct2/show/NCT05567952 |
| Study Title | EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin) |
| NCT Number | NCT03594110 Other IDs: 1245-0137|2017-002971-24 |
| Conditions | Chronic Kidney Disease |
| Interventions | DRUG: Empagliflozin|DRUG: Matching placebo |
| Sponsor | Sponsor: Boehringer Ingelheim - Collaborators: Medical Research Council Population Health Research Unit, CTSU, University of Oxford (academic lead)|Eli Lilly and Company |
| Sex | ALL |
| Age | ADULT, OLDER_ADULT |
| Phases | PHASE3 |
| Enrollment | 6609 |
| Study Type | INTERVENTIONAL |
| Study Design | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date | 31/01/2019 |
| Completion Date | 07/02/2024 |
| Locations | A.O. Univ. Policlinico "Paolo Giaccone", Palermo, 90127, Italy| |
| Study URL | https://clinicaltrials.gov/study/NCT03594110 |
| Study Title | ADVATE/ ADYNOVI Hemophilia A Outcome Database (AHEAD) |
| NCT Number | NCT02078427 Other IDs: 061001 |
| Conditions | Hemophilia A |
| Interventions | BIOLOGICAL: ADVATE|BIOLOGICAL: ADYNOVI |
| Sponsor | Baxalta now part of Shire - Collaborators: Baxalta Innovations GmbH, now part of Shire |
| Sex | ALL |
| Age | CHILD, ADULT, OLDER_ADULT |
| Phases | |
| Enrollment | 955 |
| Study Type | OBSERVATIONAL |
| Study Design | Observational Model: |Time Perspective: |
| Start Date | 29/06/2011 |
| Completion Date | 16/01/2024 |
| Locations | U.O.C. di Ematologia, Prof. Sergio Siragusa, AOUP P. Giaccone, Palermo, 90133, Italy| |
| Study URL | https://clinicaltrials.gov/study/NCT02078427 |
| Study Title | An Online-platform to Improve Patient-centered Care During the COVID-19 Pandemic: a GIMEMA Surveillance Program in Hematologic Malignancies |
| NCT Number | NCT04581187 Othr ID: GIMEMA-ALLIANCE Platform |
| Conditions | Hematologic Malignancies |
| Interventions | OTHER: Quality of life assessment |
| Sponsor | Gruppo Italiano Malattie EMatologiche dell'Adulto |
| Sex | ALL |
| Age | ADULT, OLDER_ADULT |
| Phases | |
| Enrollment | 400 |
| Study Type | OBSERVATIONAL |
| Study Design | Observational Model: |Time Perspective: p |
| Start Date | 12/02/2020 |
| Completion Date | 12/01/2024 |
| Locations | AO Ospedali Riuniti Villa Sofia Cervello - Palermo - UO Ematologia Con Utmo, Palermo, Italy | AOU Policlinico P. Giaccone - UO Ematologia, Dipartimento Biomedico di Medicina Interna e Specialistica, Palermo, Italy| |
| Study URL | https://clinicaltrials.gov/study/NCT04581187 |
| Study Title | Clinical Decision-making, Prognosis, Quality of Life and Satisfaction in Relapsed/Refractory Multiple Myeloma |
| NCT Number | NCT03190525 Othr ID: QoL-MM1016 |
| Conditions | Multiple Myeloma |
| Interventions | OTHER: Quality of life questionnaires |
| Sponsor | Gruppo Italiano Malattie EMatologiche dell'Adulto - Collaborators: |
| Sex | ALL |
| Age | ADULT, OLDER_ADULT |
| Phases | |
| Enrollment | 520 |
| Study Type | OBSERVATIONAL |
| Study Design | Observational Model: |Time Perspective: p |
| Start Date | 13/11/2017 |
| Completion Date | 12/01/2024 |
| 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/NCT03190525 |
| Study Title | Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML |
| NCT Number | NCT03250338 Other IDs: ARO-013|2017-001600-29 |
| Conditions | Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations |
| Interventions | DRUG: Crenolanib|DRUG: Cytarabine|DRUG: Mitoxantrone|DRUG: Placebo Oral Tablet|DRUG: Fludarabine|DRUG: Idarubicin|DRUG: G-CSF |
| Sponsor | Arog Pharmaceuticals, Inc. |
| Sex | ALL |
| Age | ADULT, OLDER_ADULT |
| Phases | PHASE3 |
| Enrollment | 322 |
| Study Type | INTERVENTIONAL |
| Study Design | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date | 06/05/2018 |
| Completion Date | 10/01/2024 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa | AO Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy| |
| Study URL | https://clinicaltrials.gov/study/NCT03250338 |
| Study Title | Accelerating COVID-19 Therapeutic Interventions and Vaccines 4 ACUTE |
| NCT Number | NCT04505774 Other IDs: ACTIV-4 ACUTE|1OT2HL156812-01 |
| Conditions | Covid19 |
| Interventions | DRUG: theraputic heparin|DRUG: prophylactic heparin|DRUG: P2Y12|DRUG: Crizanlizumab Injection|DRUG: SGLT2 inhibitor |
| Sponsor | Matthew Neal MD - Collaborators: National Heart, Lung, and Blood Institute (NHLBI) |
| Sex | ALL |
| Age | ADULT, OLDER_ADULT |
| Phases | PHASE4 |
| Enrollment | 880 |
| Study Type | INTERVENTIONAL |
| Study Design | Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date | 09/04/2020 |
| Completion Date | 06/01/2024 |
| Locations | U.O.C. di Malattie Infettive, Prof. Antonio Cascio, AOU Policlinico di Palermo, Palermo, Palermo, Italy| |
| Study URL | https://clinicaltrials.gov/study/NCT04505774 |
| Study Title | Early DOlutegravir/LAmivudine Switching After Virological Suppression (EDOLAS Study) |
| NCT Number | NCT04979468 Other IDs: 2019-004241-32 |
| Conditions | HIV-1-infection |
| Interventions | DRUG: DOVATO |
| Sponsor | Societa' Italiana Di Malattie Infettive E Tropicali |
| Sex | ALL |
| Age | ADULT, OLDER_ADULT |
| Phases | PHASE3 |
| Enrollment | 440 |
| Study Type | INTERVENTIONAL |
| Study Design | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER |
| Start Date | 23/03/2021 |
| Completion Date | 04/01/2024 |
| Locations | A.O.U. Policlinico "Paolo Giaccone", Palermo, PA, 90127, Italy| |
| Study URL | https://clinicaltrials.gov/study/NCT04979468 |
| Study Title | A Study to Assess Efficacy/Safety of Ladarixin in Type 1 Diabetes Patients With Preserved ß-cell Function at Baseline. |
| NCT Number | NCT04899271 Other IDs: LDX0419|2020-002966-15 |
| Conditions | New-onset Type 1 Diabetes |
| Interventions | DRUG: Ladarixin|OTHER: Placebo |
| Sponsor | Dompé Farmaceutici S.p.A |
| Sex | ALL |
| Age | ADULT |
| Phases | PHASE2 |
| Enrollment | 25 |
| Study Type | INTERVENTIONAL |
| Study Design | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date | 14/12/2020 |
| Completion Date | 04/01/2024 |
| Locations | prof.ssa Carla Giordano, U.O.C. Malattie Endocrine, del Ricambio e della Nutrizione, Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone", Palermo, 90127, Italy| |
| Study URL | https://clinicaltrials.gov/study/NCT04899271 |
| Study Title | Sequential Chemotherapy and Blinatumomab to Improve MRD Response and Survival in Acute Lymphoblastic Leukemia |
| NCT Number | NCT03367299 Other IDs: LAL2317 |
| Conditions | Acute Lymphoid Leukemia|Philadelphia Chromosome-Negative B-Cell Precursor |
| Interventions | DRUG: Chemotherapy + Blinatumomab |
| Sponsor | Gruppo Italiano Malattie EMatologiche dell'Adulto |
| Sex | ALL |
| Age | ADULT, OLDER_ADULT |
| Phases | PHASE2 |
| Enrollment | 149 |
| Study Type | INTERVENTIONAL |
| Study Design | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date | 06/08/2018 |
| Completion Date | 02/01/2024 |
| Locations | Ospedali Riuniti "Villa Sofia-Cervello", Palermo, Italy | Prof. Sergio Siragusa, Dott.ssa Maria Enza Mitra, U.O. di Ematologia con trapianto - Centro di Riferimento Regionale per le coagulopatie rare nel bambino e nell'adulto - A.U. Policlinico "Paolo Giaccone", Palermo, Italy| |
| Study URL | https://clinicaltrials.gov/study/NCT03367299 |
| Study Title | Sustained Treatment-free Remission in BCR-ABL+ Chronic Myeloid Leukemia |
| NCT Number | NCT02602314 Other IDs: CML1415 |
| Conditions | Chronyc Myeloid Leukemia |
| Interventions | DRUG: Imatinib|DRUG: Nilotinib |
| Sponsor | Gruppo Italiano Malattie EMatologiche dell'Adulto |
| Sex | ALL |
| Age | ADULT, OLDER_ADULT |
| Phases | PHASE4 |
| Enrollment | 450 |
| Study Type | INTERVENTIONAL |
| Study Design | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date | 11/11/2016 |
| Completion Date | 02/01/2024 |
| Locations | Ospedali Riuniti "Villa Sofia-Cervello", Palermo, Italy| Prof. Sergio Siragusa, Dott.ssa Maria Enza Mitra, 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/NCT02602314 |