Trial conclusi
Ascolta
| Title | A Randomised, Open-Label, Multicentre Clinical Study To Evaluate The Efficacy And Safety Of Topical Applications Of the System VULNOFAST® Plus / VULNOLIGHT® In Addition To The Usual Care Versus Usual Care Alone For The Treatment Of Infected Foot Ulcers In Diabetic Patients (PHOTOFINISH) |
| NCT Number | NCT05613985 MOLT-2019-01 |
| Conditions | Diabetic Foot Infection |
| Interventions | Other: Usual Care alone Device: System VULNOFAST® plus / VULNOLIGHT® in addition to Usual Care |
| Sponsor | L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A. |
| Gender | All |
| Age | 18 Years and older (Adult, Older Adult) |
| Phases | |
| Enrollment | 146 participants |
| Study Type | Interventional (Clinical Trial) |
| Study Designs | Parallel Assignment |
| Start Date | 14/09/2021 |
| Completion Date | 31/12/2023 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Malattie Endocrine, del Ricambio e della Nutrizione, Prof.ssa Carla Giordano |
| URL | https://www.clinicaltrials.gov/ct2/show/NCT05613985 |
| Title | ICT Tools for the Diagnosis of Autoimmune Diseases in the Mediterranean Area - CAPITALISATION PROJECT |
| NCT Number | NCT05715970 ACPM32 |
| Conditions | Celiac Disease |
| Interventions | Diagnostic Test: PoCT+questionnaire administration |
| Sponsor | Pasquale Mansueto, University of Palermo |
| Gender | All |
| Age | 12 Years and older (Child, Adult, Older Adult) |
| Phases | |
| Enrollment | 25000 participants |
| Study Type | Interventional (Clinical Trial) |
| Study Designs | Single Group Assignment |
| Start Date | 01/06/2023 |
| Completion Date | 31/12/2023 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo, prof. Pasquale Mansueto, prof. Antonio Carroccio |
| URL | https://www.clinicaltrials.gov/ct2/show/NCT05715970 |
| Title | The Role of Gut-skin Axis in Psoriasis: a Randomized Placebo-controlled Dietary Approach to Assess Clinical Efficacy in Mild-to-moderate Psoriasis |
| NCT Number | NCT05644782 ACPM30 |
| Conditions | Psoriasis Gluten Sensitivity |
| Interventions | Other: Open wheat challenge Other: Placebo challenge |
| Sponsor | Pasquale Mansueto, University of Palermo |
| Gender | All |
| Age | 18 Years to 65 Years (Adult, Older Adult) |
| Phases | |
| Enrollment | 82 participants |
| Study Type | Interventional (Clinical Trial) |
| Study Designs | Parallel Assignment |
| Start Date | 01/01/2023 |
| Completion Date | 31/12/2023 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo, prof. Pasquale Mansueto, prof.ssa Maria Rita Bongiorno, prof. Antonio Carroccio |
| URL | https://www.clinicaltrials.gov/ct2/show/NCT05644782 |
| Title | Urinary Gluten Detection in Patients With Non-celiac Gluten/Wheat Sensitivity |
| NCT Number | NCT04219813 ACPM24 |
| Conditions | Non-celiac Gluten/Wheat Sensitivity |
| Interventions | Other: Urinary test |
| Sponsor | Pasquale Mansueto, University of Palermo |
| Gender | All |
| Age | 18 Years to 75 Years (Adult, Older Adult) |
| Phases | |
| Enrollment | 40 participants |
| Study Type | Interventional (Clinical Trial) |
| Study Designs | Single Group Assignment |
| Start Date | 01/01/2021 |
| Completion Date | 31/12/2023 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo, Pasquale Mansueto, University of Palermo (Responsible Party) |
| URL | https://www.clinicaltrials.gov/ct2/show/NCT04219813 |
| Title | Adaptive, Randomized, Non-inferiority Trial on the Use of Monoclonal Antibodies or Antivirals in Outpatients With Mild or Moderate COVID-19 |
| NCT Number | NCT05321394 MANTICO 2 2021-002612-31 ( EudraCT Number ) |
| Conditions | COVID-19 |
| Interventions | Drug: Sotrovimab Drug: Tixagevimab Cilgavimab Drug: Nirmatrelvir Ritonavir |
| Sponsor | Evelina Tacconelli, Azienda Ospedaliera Universitaria Integrata Verona |
| Gender | All |
| Age | 50 Years and older (Adult, Older Adult) |
| Phases | Phase 3 |
| Enrollment | 1095 participants |
| Study Type | Interventional (Clinical Trial) |
| Study Designs | Parallel Assignment |
| Start Date | 07/03/2022 |
| Completion Date | 30/12/2023 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Malattie Infettive, Prof. Antonio Cascio |
| URL | https://www.clinicaltrials.gov/ct2/show/NCT05321394 |
| Title | A Study of Guselkumab in Naive or Bio-experienced Participants With Regional (Facial and Genital) Psoriasis |
| NCT Number | NCT04439526 Other IDs: CR108761|CNTO1959PSO4013 |
| Conditions | Psoriasis |
| Interventions | DRUG: Guselkumab |
| Sponsor | Janssen-Cilag S.p.A. |
| Sex | ALL |
| Age | ADULT, OLDER_ADULT |
| Phases | |
| Enrollment | 400 |
| Study Type | OBSERVATIONAL |
| Study Design | Observational Model: |Time Perspective: p |
| Start Date | 06/10/2020 |
| Completion Date | 30/12/2023 |
| Locations | Dermatologia, Prof.ssa Maria Rita Bongiorno, Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone, Palermo, 90127, Italy| |
| Study URL | https://clinicaltrials.gov/study/NCT04439526 |
| Title | A phase 2, randomized, open-label, multicenter study to evaluate safety and efficacy of single agent selinexor versus treatment of physician's choice in patients with previously treated myelofibrosis Studio multicentrico di fase 2, randomizzato, in aperto, per valutare la sicurezza e l’efficacia di selinexor come singolo agente rispetto al trattamento scelto dal medico in pazienti con mielofibrosi precedentemente trattata |
| EudraCT number | 2020-003809-60 XPORT - MF-035 |
| Conditions | Myelofibrosis Mielofibrosi |
| Interventions | |
| Sponsor Name | KARYOPHARM THERAPEUTICS, INC. |
| Gender | Female; Male |
| Age | Adults; Elderly; |
| Phases | Phase II |
| Enrollment | 112 |
| Study Type | Therapeutic exploratory (Phase II) |
| Study Designs | Controlled; Randomised; Open; Parallel group; |
| Start Date | 31/08/2021 |
| Completion Date | 29/12/2023 |
| Locations | United States Italy: A.O.U. Policlinico P. Giaccone Palermo,U.O.C. di Ematologia, Dott. Marco Santoro |
| URL | https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-003809-60/IT |
| Title | A randomized double-blind, placebo-controlled, multicenter trial assessing the impact of lipoprotein (a) lowering with pelacarsen (TQJ230) on major cardiovascular events in patients with establishe... |
| EudraCT Number | 2019-001076-11 |
| Conditions | Cardiovascular Disease, Atherosclerosis |
| Interventions | |
| Sponsor Name | Novartis Pharma AG |
| Gender | Male, Female |
| Age | Adults, Elderly |
| Phases | |
| Enrollment | |
| Study Type | |
| Study Designs | |
| Start Date | 19/12/2019 |
| Completion Date | 19/12/2023 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo Prof. Angelo Baldassare Cefalù, Principal Investigator |
| URL | https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-001076-11/IT |
| Title | SELECT - Semaglutide effects on cardiovascular outcomes in people with overweight or obesity SELECT - Effetti di semaglutide sugli esiti cardiovascolari in persone obese o in sovrappeso |
| EudraCT number | 2017-003380-35 |
| Conditions | Overweight Obesity Sovrappeso Obesita |
| Interventions | |
| Sponsor | NOVO NORDISK. S.P.A. |
| Gender | Female; Male |
| Age | Adults; Elderly; |
| Phases | Phase III |
| Enrollment | 17500 |
| Study Type | Therapeutic confirmatory (Phase III) |
| Study Designs | Controlled; Randomised; Parallel group; |
| Start Date | 13/12/2018 |
| Completion Date | 12/12/2023 |
| Locations | Italy - A.O.U. Policlinico P. Giaccone Palermo |
| URL | https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-003380-35/IT |
| Title | RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA) |
| NCT Number | NCT04620733 - Other IDs: CB8025-32048 |
| Conditions | Primary Biliary Cholangitis |
| Interventions | DRUG: Seladelpar 10 mg|DRUG: Placebo|DRUG: Seladelpar 5 mg |
| Sponsor | CymaBay Therapeutics, Inc. |
| Sex | ALL |
| Age | ADULT, OLDER_ADULT |
| Phases | PHASE3 |
| Enrollment | 193 |
| Study Type | INTERVENTIONAL |
| Study Design | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date | 21/04/2021 |
| Completion Date | 08/11/2023 |
| Locations | Prof.ssa Vincenza Calvaruso, U.O.C. di Gastroenterologia, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo, 90127, Italy| |
| Study URL | https://clinicaltrials.gov/study/NCT04620733 |
| Title | A Multi-centre, Prospective, Non-interventional Single-arm Study Investigating Clinical Parameters Associated With the Use of Once-daily Oral Semaglutide in a Real-world Adult Population With Type 2 Diabetes in Italy |
| NCT Number | NCT05230615 |
| Conditions | Diabetes Mellitus, Type 2 |
| Interventions | Drug: Oral semaglutide |
| Sponsor | Novo Nordisk A/S |
| Gender | All |
| Age | age above or equal to 18 years |
| Phases | |
| Enrollment | 462 |
| Study Type | Observational |
| Study Designs | Observational Model: Cohort Time Perspective: Prospective |
| Start Date | 01/04/2022 |
| Completion Date | 03/11/2023 |
| Locations | Sperimentatore: Prof. ssa Carla Giordano Centro: U.O.C. di Endocrinologia Sponsor: Novo Nordisk A/S CRO: IQVIA |
| URL | https://clinicaltrials.gov/ct2/show/NCT05230615 |
| Title | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of AKCEA-APOCIII-LRx Administered Subcutaneously to Patients With Familial Chylomicronemia Syndrome (FCS) |
| NCT Number | NCT04568434 - (EudraCT Number: 2020-002536-67) |
| Conditions | Familial Chylomicronemia Syndrome |
| Interventions | Drug: Olezarsen Drug: Placebo |
| Sponsor | Sponsor: Ionis Pharmaceuticals, Inc. Collaborator: Akcea Therapeutics |
| Gender | All |
| Age | 18 Years and older (Adult, Older Adult) |
| Phases | Phase 3 |
| Enrollment | 66 |
| Study Type | Interventional |
| Study Designs | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
| Start Date | 16/11/2020 |
| Completion Date | 31/10/2023 |
| Locations | Italy ASST Grande Ospedale Metropolitano Niguarda - Milano, Italy, 20162 Azienda Ospedaliera Universitaria Federico II - Napoli, Italy, 80131 Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone - Palermo, Italy, 90127 Prof. Angelo Baldassare Cefalù, Principal Investigator Azienda Ospedaliero Universitaria Policlinico Umberto I - Roma, Italy, 00161 and other 48 international study locations |
| URL | https://ClinicalTrials.gov/show/NCT04568434 |
<td >Controlled; Randomised;
| 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 UNO STUDIO DI FASE 2, INTERVENTISTICO, RANDOMIZZATO, IN DOPPIO CIECO, A DUE BRACCI, PER VALUTARE L’EFFICACIA E LA SICUREZZA DI UN CICLO RIPETUTO DI 5 GIORNI DI NIRMATRELVIR/RITONAVIR RISPETTO A PLACEBO/RITONAVIR IN PARTECIPANTI DI ALMENO 12 ANNI DI ETÀ CON RICOMPARSA DEI SINTOMI DI COVID-19 E POSITIVITÀ AL TEST ANTIGENICO RAPIDO |
| EudraCT number | 2022-002827-36 C4671042 |
| Medical condition | SARS-CoV-2 Infection Infezione da SARS-CoV-2 |
| Interventions | |
| Sponsor/Collaborators | PFIZER INC |
| Gender | Female; Male |
| Population Age | Adolescents (12-17 years); Adults; Elderly; |
| Phases | Phase II |
| Enrollment | 411 |
| Trial type | Therapeutic exploratory (Phase II) |
| Design of the trial | |
| Start Date | 20/02/2023 |
| Completion Date | 18/10/2023 |
| Locations | United States - A.O.U. Policlinico P. Giaccone Palermo, Prof. Antonio Cascio, U.O.C. Malattie Infettive |
| URL | https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-002827-36/IT |
| Title | A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis |
| NCT Number | NCT04594707 Other IDs: WA42294|2020-001429-30 |
| Conditions | Idiopathic Pulmonary Fibrosis |
| Interventions | DRUG: PRM-151 (Zinpentraxin Alfa) |
| Sponsor | Hoffmann-La Roche |
| Sex | ALL |
| Age | CHILD, ADULT, OLDER_ADULT |
| Phases | PHASE3 |
| Enrollment | 117 |
| Study Type | INTERVENTIONAL |
| Study Design | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date | 30/08/2021 |
| Completion Date | 02/10/2023 |
| Locations | prof. Nicola Scichilone, U.O.C. di Pneumologia, Az. Osp. Univ. P. Giaccone, Palermo, Sicilia, 90127, Italy| Ismett Istituto Mediterraneo Trapianti E Terapie Alta Specializzazione;Pneumologia, Palermo, Sicilia, 90127, Italy| |
| Study URL | https://clinicaltrials.gov/study/NCT04594707 |
| Title | A Study to Evaluate the Efficacy and Safety of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis |
| NCT Number | NCT04552899 Other IDs: WA42293|2020-000791-38 |
| Conditions | Idiopathic Pulmonary Fibrosis |
| Interventions | DRUG: PRM-151 (Zinpentraxin Alfa)|DRUG: Placebo |
| Sponsor | Hoffmann-La Roche |
| Sex | ALL |
| Age | ADULT, OLDER_ADULT |
| Phases | PHASE3 |
| Enrollment | 665 |
| Study Type | INTERVENTIONAL |
| Study Design | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date | 19/03/2021 |
| Completion Date | 02/10/2023 |
| Locations | prof. Nicola Scichilone, U.O.C. di Pneumologia, Az. Osp. Univ. P. Giaccone, Palermo, Sicilia, 90127, Italy| Ismett Istituto Mediterraneo Trapianti E Terapie Alta Specializzazione;Pneumologia, Palermo, Sicilia, 90127, Italy| |
| Study URL | https://clinicaltrials.gov/study/NCT04552899 |
| Title | Contribution of KIR Genes on the Genetic Predisposition to Non-Celiac Wheat Sensitivity |
| NCT Number | NCT05469971 |
| Conditions | Non-celiac Wheat Sensitivity |
| Interventions | Genetic: KIR genotyping |
| Sponsor | Pasquale Mansueto, University of Palermo |
| Gender | All |
| Age | 18 Years to 65 Years (Adult, Older Adult) |
| Phases | |
| Enrollment | 150 participants |
| Study Type | Observational |
| Study Designs | Observational Model: Case-Control Time Perspective: Retrospective |
| Start Date | 01/11/2022 |
| Completion Date | 30/09/2023 |
| Locations | prof. Pasquale Mansueto, University of Palermo |
| URL | https://clinicaltrials.gov/ct2/show/NCT05469971 |
| Title | Retro-prospective Observational Study on Risk of Progression in Chronic Phase-Chronic Myeloid Leukemia Patients Eligible for Tyrosine Kinase Inhibitor Discontinuation (TFR - PRO) |
| NCT Number | NCT04621851 TFR-PRO |
| Conditions | Chronic Myeloid Leukemia |
| Interventions | |
| Sponsor | CARLO GAMBACORTI PASSERINI, University of Milano Bicocca |
| Gender | All |
| Age | 18 Years and older (Adult, Older Adult) |
| Phases | |
| Enrollment | 3000 participants |
| Study Type | Observational [Patient Registry] |
| Study Designs | Cohort |
| Start Date | 30/09/2020 |
| Completion Date | 30/09/2023 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa, dott. Accurso |
| URL | https://www.clinicaltrials.gov/ct2/show/NCT04621851 |
| Title | Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment |
| NCT Number | NCT02548351 Other IDs: 747-303 |
| Conditions | Non Alcoholic Steatohepatitis (NASH) |
| Interventions | DRUG: Obeticholic Acid|DRUG: Placebo |
| Sponsor | Intercept Pharmaceuticals |
| Sex | ALL |
| Age | ADULT, OLDER_ADULT |
| Phases | PHASE3 |
| Enrollment | 2480 |
| Study Type | INTERVENTIONAL |
| Study Design | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date | 22/09/2015 |
| Completion Date | 15/09/2023 |
| Locations | Prof. Salvatore Petta, Gastroenterologia, Dir. Prof. Calogero Cammà, Policlinico Paolo Giaccone di Palermo, Palermo, 90127, Italy| |
| Study URL | https://clinicaltrials.gov/study/NCT02548351 |
| Title | An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) Studio di estensione in aperto per valutare la sicurezza, la tollerabilità e l’efficacia a lungo termine di rozanolixizumab in soggetti con trombocitopenia immune (ITP) primaria persistente o cronica |
| EudraCT number | 2019-000883-40 |
| Conditions | Primary Immune Thrombocytopenia Trombocitopenia immune primaria |
| Interventions | |
| Sponsor | UCB Biopharma SRL |
| Gender | Female; Male |
| Age | Adults; Elderly; |
| Phases | Phase III |
| Enrollment | 210 |
| Study Type | Therapeutic confirmatory (Phase III) |
| Study Designs | |
| Start Date | 14/12/2020 |
| Completion Date | 11/08/2023 |
| Locations | Germany Italy - A.O.U. Policlinico P. Giaccone Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa |
| URL | https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-000883-40/IT |
| Title | Burden of Hepatitis D Virus (HDV) Infection in Italy: a Prospective/Observational Multicenter Study to Define Demographic, Clinical and Virological Features |
| NCT Number | NCT05723068 IN-IT-980-6382 |
| Conditions | Chronic Hepatitis D |
| Interventions | |
| Sponsor | University of Turin, Italy |
| Gender | All |
| Age | 18 Years and older (Adult, Older Adult) |
| Phases | |
| Enrollment | 500 participants |
| Study Type | Observational |
| Study Designs | Cohort |
| Start Date | 24/08/2022 |
| Completion Date | 01/07/2023 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo, prof. Antonio Craxì |
| URL | https://www.clinicaltrials.gov/ct2/show/NCT05723068 |
| Title | Randomised, Open-label and Parallel Group Trial to Investigate the Effects of Oral BI 685509 Alone or in Combination With Empagliflozin on Portal Hypertension After 8 Weeks Treatment in Patients With Clinically Significant Portal Hypertension (CSPH) in Compensated Cirrhosis |
| NCT Number | NCT05282121 1366-0029 2021-005171-40 ( EudraCT Number ) |
| Conditions | Liver Diseases Hypertension, Portal |
| Interventions | Parallel Assignment |
| Sponsor | Boehringer Ingelheim |
| Gender | All |
| Age | 18 Years to 75 Years (Adult, Older Adult) |
| Phases | Phase 2 |
| Enrollment | 80 participants |
| Study Type | Interventional (Clinical Trial) |
| Study Designs | Allocation: Randomized | Intervention Model: Parallel Assignment | Masking: None (Open Label) | Primary Purpose: Treatment |
| Start Date | 26/05/2022 |
| Completion Date | 28/07/2023 |
| Locations | Sperimentatore: Prof.ssa V. Calvaruso Centro: U.O.C. di Gastroenterologia |
| URL | https://clinicaltrials.gov/ct2/show/NCT05282121 |
| Title | Italian adult Immune ThrombocytoPenia (ITP) Registry Investigation on a Dynamic Cohort of Italian Patients With Active ITP |
| NCT Number | NCT03465020 |
| Conditions | Intervention/treatment Idiopathic Thrombocytopenic Purpura Other: Observation |
| Interventions | |
| Sponsor | Gruppo Italiano Malattie EMatologiche dell'Adulto |
| Gender | All |
| Age | 18 Years and older (Adult, Older Adult) |
| Phases | |
| Enrollment | 861 participants |
| Study Type | Observational [Patient Registry] |
| Study Designs | Cohort |
| Start Date | 15/10/2018 |
| Completion Date | 01/07/2023 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo - UO Ematologia, Prof. Sergio Siragusa |
| URL | https://www.clinicaltrials.gov/ct2/show/NCT03465020 |
| Title | Effect of Totum-63 on Glucose and Lipid Homeostasis in Subjects With Dysglycemia (REVERSE-IT) |
| NCT Number | NCT04423302 Other IDs: PEC16075|2020-A00604-35 |
| Conditions | Prediabetic State|Diabetes type2|Dysglycemia |
| Interventions | DIETARY_SUPPLEMENT: TOTUM-63 3 intakes per day|DIETARY_SUPPLEMENT: Placebo 3 intakes per day|DIETARY_SUPPLEMENT: TOTUM-63 2 intakes per day |
| Sponsor | Valbiotis - Collaborators: Biofortis Mérieux NutriSciences |
| Sex | ALL |
| Age | ADULT, OLDER_ADULT |
| Phases | NA |
| Enrollment | 636 |
| Study Type | INTERVENTIONAL |
| Study Design | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION |
| Start Date | 07/08/2020 |
| Completion Date | 23/06/2023 |
| Locations | prof. Silvio Buscemi, U.O.C. Nutrizione Clinica, Obesità e Metabolismo, Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone", Palermo, 90127, Italy| |
| Study URL | https://clinicaltrials.gov/study/NCT04423302 |
| Title | A Study to Test Safety and Efficacy of BI456906 in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3) |
| NCT Number | NCT04771273 Other IDs: 1404-0043|2020-002723-11 |
| Conditions | Non-alcoholic Steatohepatitis (NASH) |
| Interventions | DRUG: BI 456906|DRUG: Placebo |
| Sponsor | Boehringer Ingelheim |
| Sex | ALL |
| Age | ADULT, OLDER_ADULT |
| Phases | PHASE2 |
| Enrollment | 295 |
| Study Type | INTERVENTIONAL |
| Study Design | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date | 27/04/2021 |
| Completion Date | 12/06/2023 |
| Locations | Prof. Salvatore Petta, Gastroenterologia, Dir. Prof. Calogero Cammà, A.O. Univ. Policlinico "Paolo Giaccone", Palermo, 90127, Italy| |
| Study URL | https://clinicaltrials.gov/study/NCT04771273 |
| Title | A Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease (AD) |
| NCT Number | NCT04374253 Other IDs: WN42171|2020-000766-42 |
| Conditions | Alzheimer Disease |
| Interventions | DRUG: Gantenerumab|DRUG: Gantenerumab |
| Sponsor | Hoffmann-La Roche |
| Sex | ALL |
| Age | CHILD, ADULT, OLDER_ADULT |
| Phases | PHASE3 |
| Enrollment | 1379 |
| Study Type | INTERVENTIONAL |
| Study Design | Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date | 02/01/2021 |
| Completion Date | 03/06/2023 |
| Locations | Prof. Mario Barbagallo, UOC Geriatria, Dipartimento delle Patologie Emergenti; Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo, Sicilia, 90127, Italy| |
| Study URL | https://clinicaltrials.gov/study/NCT04374253 |
| Title | A Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-Experienced Adults 50 Years of Age or Older |
| NCT Number | NCT05420961 V116-006 jRCT2071220025 ( Registry Identifier: jRCT ) 2021-006679-41 ( EudraCT Number ) |
| Conditions | Pneumonia, Pneumococcal |
| Interventions | Parallel Assignment |
| Sponsor | Merck Sharp & Dohme LLC |
| Gender | All |
| Age | 50 Years and older (Adult, Older Adult) |
| Phases | Phase 3 |
| Enrollment | 700 participants |
| Study Type | Interventional (Clinical Trial) |
| Study Designs | Allocation: Randomized | Intervention Model: Parallel Assignment | Masking: Double (Participant, Investigator) | Masking Description: Cohorts 1 and 2: participants, investigator, Sponsor Cohort 3: no blinding |
| Start Date | 12/07/2022 |
| Completion Date | 18/05/2023 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo: Claudio Costantino (MED/42), Francesco Vitale (MED/42), Carmelo Massimo Maida (MED/42), Fabio Tramuto (MED/42), Vincenzo Restivo (MED/42) |
| URL | https://clinicaltrials.gov/ct2/show/NCT05420961 |
| Title | A Multicenter, Cross-sectional Study to Characterize the Distribution of Lipoprotein(a) Levels Among Patients With Documented History of Atherosclerotic Cardiovascular Disease |
| NCT Number | NCT05378529 - AMG 20210057 |
| Conditions | Atherosclerotic Cardiovascular Disease |
| Interventions | Other: Lp(a) Screening |
| Sponsor | Amgen |
| Gender | All |
| Age | 18 Years to 85 Years (Adult, Older Adult) |
| Phases | Not Applicable |
| Enrollment | 40000 |
| Study Type | Interventional |
| Study Designs | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
| Start Date | 19/04/2022 |
| Completion Date | 22/05/2023 |
| Locations | Italy Azienda Ospedaliero Universitaria di Bologna Policlinico S Orsola Malpighi - Bologna, Italy, 40138 Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia - Brescia, Italy, 25123 Azienda Ospedaliera Sant Anna e San Sebastiano - Caserta, Italy, 81100 Azienda Ospedaliera Universitaria di Ferrara Arcispedale Sant Anna - Ferrara, Italy, 44124 Ospedale Policlinico San Martino IRCCS - Genova, Italy, 16132 IRCCS Centro Cardiologico Monzino - Milano, Italy, 20138 Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda - Milano, Italy, 20162 Azienda Ospedaliera Universitaria Maggiore della Carita - Novara, Italy, 28100 Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone - Palermo, Italy, 90127 Prof. Angelo Baldassare Cefalù, Principal Investigator Fondazione Policlinico Tor Vergata - Roma, Italy, 00133 IRCCS Istituto Clinico Humanitas - Rozzano MI, Italy, 20089 Azienda Ospedaliera Ordine Mauriziano di Torino - Torino, Italy, 10128 and other 607 international study locations |
| URL | https://ClinicalTrials.gov/show/NCT05378529 https://www.amgentrials.com/study/?id=20210057 |
| Title | A Double-blind, Randomized, Placebo-controlled Phase 2 Study to Evaluate Efficacy, Safety, and Tolerability of Olpasiran (AMG 890) in Subjects With Elevated Lipoprotein(a) |
| NCT Number | NCT04270760 20180109 2019-003688-23 ( EudraCT Number ) |
| Conditions | |
| Interventions | Parallel Assignment |
| Sponsor | Amgen |
| Gender | All |
| Age | 18 Years to 80 Years (Adult, Older Adult) |
| Phases | |
| Enrollment | 700 participants |
| Study Type | Interventional (Clinical Trial) |
| Study Designs | Allocation: Randomized | Intervention Model: Parallel Assignment | Masking: Double (Participant, Investigator) | Primary Purpose: Treatment |
| Start Date | 28/07/2020 |
| Completion Date | 18/05/2023 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo |
| URL | https://clinicaltrials.gov/ct2/show/NCT04270760 |
| Title | Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies |
| NCT Number | NCT02118584 Other IDs: GA28951|2013-004435-72 |
| Conditions | Ulcerative Colitis |
| Interventions | DRUG: Etrolizumab |
| Sponsor | Hoffmann-La Roche |
| Sex | ALL |
| Age | ADULT, OLDER_ADULT |
| Phases | PHASE3 |
| Enrollment | 1822 |
| Study Type | INTERVENTIONAL |
| Study Design | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date | 15/09/2014 |
| Completion Date | 10/05/2023 |
| Locations | Prof. Sergio Peralta, Gastroenterologia, Dir. Prof. Calogero Cammà, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo, Sicilia, 90127, Italy| |
| Study URL | https://clinicaltrials.gov/study/NCT02118584 |
| Title | Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Rheumatoid Arthritis (RA) |
| NCT Number | NCT04888585 Other IDs: M20-466|2020-005303-39 |
| Conditions | Rheumatoid Arthritis (RA) |
| Interventions | DRUG: ABBV-154|DRUG: Placebo |
| Sponsor | AbbVie |
| Sex | ALL |
| Age | ADULT, OLDER_ADULT |
| Phases | PHASE2 |
| Enrollment | 473 |
| Study Type | INTERVENTIONAL |
| Study Design | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date | 06/02/2021 |
| Completion Date | 08/04/2023 |
| Locations | Prof.ssa Giuliana Guggino, Reumatologia, Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 228583, Palermo, 90127, Italy| |
| Study URL | https://clinicaltrials.gov/study/NCT04888585 |
| Title | The Benefit/Risk Profile of Pegylated Proline-Interferon Alpha-2b (AOP2014) Added to the Best Available Strategy Based on Phlebotomies in Low-risk Patients With Polycythemia Vera (PV). The Low-PV Randomized Trial |
| NCT Number | NCT03003325 Low-PV |
| Conditions | Polycythemia Vera |
| Interventions | |
| Sponsor | Fondazione per la Ricerca Ospedale Maggiore |
| Gender | All |
| Age | 18 Years to 60 Years (Adult) |
| Phases | Phase 2 |
| Enrollment | |
| Study Type | Interventional (Clinical Trial) |
| Study Designs | Parallel Assignment |
| Start Date | 02/02/2017 |
| Completion Date | 31/03/2023 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa |
| URL | https://www.clinicaltrials.gov/ct2/show/NCT03003325 |
| Title | Efficacy and Safety Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD) |
| NCT Number | NCT03444870 Other IDs: WN29922|2017-001364-38 |
| Conditions | Alzheimer Disease |
| Interventions | DRUG: Gantenerumab|DRUG: Placebo |
| Sponsor | Hoffmann-La Roche |
| Sex | ALL |
| Age | ADULT, OLDER_ADULT |
| Phases | PHASE3 |
| Enrollment | 1054 |
| Study Type | INTERVENTIONAL |
| Study Design | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date | 06/06/2018 |
| Completion Date | 17/02/2023 |
| Locations | Prof. Mario Barbagallo, UOC Geriatria, Dipartimento delle Patologie Emergenti; Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo, Sicilia, 90127, Italy| |
| Study URL | https://clinicaltrials.gov/study/NCT03444870 |
| Title | EU SolidAct: An Adaptive Pandemic and Emerging Infection Platform Trial |
| NCT Number | NCT04891133 Other IDs: EU SolidAct|2022-500385-99-00 |
| Conditions | COVID-19|Emerging Infectious Disease |
| Interventions | DRUG: Baricitinib|DRUG: Placebo |
| Sponsor | Oslo University Hospital - Collaborators: Institut National de la Santé Et de la Recherche Médicale, France|Epidemiological and Clinical Research Information Network |
| Sex | ALL |
| Age | ADULT, OLDER_ADULT |
| Phases | PHASE2|PHASE3 |
| Enrollment | 290 |
| Study Type | INTERVENTIONAL |
| Study Design | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date | 06/03/2021 |
| Completion Date | 23/01/2023 |
| Locations | U.O.C. di Malattie Infettive, Prof. Antonio Cascio, AOU Policlinico "P. Giaccone", Palermo, 90127, Italy| |
| Study URL | https://clinicaltrials.gov/study/NCT04891133 |
| Title | Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis |
| NCT Number | NCT04023396 Other IDs: ABX464-104 |
| Conditions | Ulcerative Colitis |
| Interventions | DRUG: ABX464 |
| Sponsor | Abivax S.A. |
| Sex | ALL |
| Age | ADULT, OLDER_ADULT |
| Phases | PHASE2 |
| Enrollment | 217 |
| Study Type | INTERVENTIONAL |
| Study Design | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date | 13/01/2020 |
| Completion Date | 03/01/2023 |
| Locations | Dott.ssa Maria Cappello, Gastroenterologia , Direttore Prof. Calogero Cammà, Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone, Palermo, Italy| |
| Study URL | https://clinicaltrials.gov/study/NCT04023396 |
| Title | Activity and Risk Profile of Ponatinib in Chronic Phase Patients With Chronic Myeloid Leukemia Resistant to Imatinib |
| NCT Number | NCT02398825 Other IDs: CML1315|2015-001102-34 |
| Conditions | Chronic Myeloid Leukemia|Chronic Phase|Adults |
| Interventions | DRUG: Ponatinib |
| Sponsor | Gruppo Italiano Malattie EMatologiche dell'Adulto |
| Sex | ALL |
| Age | ADULT, OLDER_ADULT |
| Phases | PHASE2 |
| Enrollment | 16 |
| Study Type | INTERVENTIONAL |
| Study Design | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date | 23/06/2016 |
| Completion Date | 02/01/2023 |
| Locations | AO Ospedali Riuniti Villa Sofia Cervello - Palermo - UO Ematologia con UTMO, Palermo, Italy| Dott. Vincenzo Accurso, Ematologia, Dir. Prof. Sergio Mario Siragusa,AOU Policlinico P. Giaccone - Palermo, Palermo, Italy| |
| Study URL | https://clinicaltrials.gov/study/NCT02398825 |
| Title | Not-celiac Wheat Sensitivity (NCWS) in Patients With Irritable Bowel Syndrome. Randomized Double-Blind Placebo-Controlled Trial (Wheat vs Placebo) for Bio-markers Identification of NCWS and Understanding Its Pathogenetic Mechanisms. |
| NCT Number | NCT01762579 |
| Conditions | Not-celiac Wheat Sensitivity |
| Interventions | Parallel Assignment Dietary Supplement: wheat flour Dietary Supplement: Xylose |
| Sponsor | Pasquale Mansueto, University of Palermo |
| Gender | All |
| Age | 18 Years to 65 Years (Adult, Older Adult) |
| Phases | |
| Enrollment | 100 participants |
| Study Type | Interventional (Clinical Trial) |
| Study Designs | Allocation: Randomized | Intervention Model: Parallel Assignment | Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) | Primary Purpose: Diagnostic |
| Start Date | 01/01/2012 |
| Completion Date | 01/01/2023 |
| Locations | Internal Medicine, University Hospital Palermo, Italy, 90100 Contact: Antonio Carroccio, PHD Contact: Pasquale Mansueto, MD Sub-Investigator: Alberto D'Alcamo, MD Sub-Investigator: Giusi Randazzo, MD Sub-Investigator: Miriam Carta, MD Sub-Investigator: Giuseppe Taormina, MD |
| URL | https://clinicaltrials.gov/ct2/show/NCT01762579 |
| Full title | Real-world Use of Carfilzomib Among Multiple Myeloma Patients in Europe Who Have Received at Least One Prior Therapy. |
| NCT Number | NCT03091127 |
| Conditions | Multiple Myeloma |
| Sponsor/Collaborators | Amgen |
| Gender | All |
| Age | 18 Years and older (Adult, Older Adult) |
| Phases | |
| Enrollment | 705 participants |
| Study Type | Observational |
| Study Designs | Cohort |
| Start Date | 14/03/2017 |
| Completion Date | 12/12/2022 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Dott. Cirino Botta |
| URL | https://www.clinicaltrials.gov/ct2/show/NCT03091127 |
| Title | A 78-week Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Glargine 100 Units/mL, Both in Combination With Non-insulin Anti-diabetic Treatment, in Insulin naïve Subjects With Type 2 Diabetes |
| NCT Number | NCT04460885 NN1436-4477 U1111-1247-3878 ( Other Identifier: World Health Organization (WHO) ) 2020-000442-34 ( EudraCT Number ) |
| Conditions | Diabetes Mellitus, Type 2 |
| Interventions | Parallel Assignment |
| Sponsor/Collaborators | Novo Nordisk A/S |
| Gender | All |
| Age | 18 Years and older (Adult, Older Adult) |
| Phases | Phase 3 |
| Enrollment | 5000 participants |
| Study Type | Interventional (Clinical Trial) |
| Study Designs | Allocation: Randomized | Intervention Model: Parallel Assignment | Masking: None (Open Label) | Primary Purpose: Treatment |
| Start Date | 25/11/2020 |
| Completion Date | 01/12/2022 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo |
| URL | https://clinicaltrials.gov/ct2/show/NCT04460885 |
| Title | Liver Investigation: Testing Marker Utility in Steatohepatitis (LITMUS): Assessment & Validation of Imaging Modality Performance Across the NAFLD Spectrum in a Prospectively Recruited Cohort |
| NCT Number | NCT05479721 IRAS ID 250344 18/LO/1953 (Other Identifier: NHS Health Research Authority) |
| Conditions | NAFLD NASH NASH - Nonalcoholic Steatohepatitis Fibrosis, Liver Steatosis of Liver |
| Interventions | |
| Sponsor/Collaborators | University of Oxford |
| Gender | All |
| Age | 18 Years to 100 Years (Adult, Older Adult) |
| Phases | |
| Enrollment | 450 participants |
| Study Type | Observational |
| Study Designs | Cohort |
| Start Date | 04/09/2019 |
| Completion Date | 31/10/2022 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. Gastroenterologia, prof. Salvatore Petta |
| URL | https://www.clinicaltrials.gov/ct2/show/NCT05479721 |
| Title | Safety, Tolerability, and Immunogenicity of Vaxelis™ in Children Previously Vaccinated With Vaxelis™ or Hexyon™ (V419-016) |
| NCT Number | NCT05289271 - (EudraCT Number: 2021-004053-23) |
| Conditions | Vaccines, Combined Hexavalent Vaccine |
| Interventions | Biological: Vaxelis™ |
| Sponsor/Collaborators | Merck Sharp & Dohme LLC |
| Gender | All |
| Age | 11 Months to 13 Months (Child) |
| Phases | Phase 4 |
| Enrollment | 169 |
| Study Type | Interventional |
| Study Designs | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
| Start Date | 25/03/2022 |
| Completion Date | 30/08/2022 |
| Locations |
A.O.U. Policlinico Paolo Giaccone ( Site 0102) - Palermo, Sicilia, Italy, 90127 |
| URL | https://ClinicalTrials.gov/show/NCT05289271 |
| Title | Follow Up of acuTe Heart failUre: a pRospective Echocardiographic and Clinical Study (FUTURE) |
| NCT Number | NCT05204238 |
| Conditions | Heart Failure|Heart Failure With Preserved Ejection Fraction|Heart Failure With Mid Range Ejection Fraction|Heart Failure With Reduced Ejection Fraction |
| Interventions | Diagnostic Test: Transthoracic Echocardiography |
| Sponsor/Collaborators | University of Siena|European Association of Cardiovascular Imaging |
| Gender | All |
| Age | 18 Years and older (Adult, Older Adult) |
| Phases | |
| Enrollment | 998 |
| Study Type | Observational |
| Study Designs | Observational Model: Cohort|Time Perspective: Prospective |
| Start Date | 01/09/2020 |
| Completion Date | 30/11/2022 |
| Locations | Italy|Cardiology Unit, Department of Excellence of Sciences for Health Promotion and Mothernal-Child Care, Internal Medicine and Specialities (ProMISE), University of Palermo, University Hospital Paolo Giaccone, Palermo |
| URL | https://ClinicalTrials.gov/show/NCT05204238 |
| Title | SARS-CoV-2 Infection in Patients With Hematological Malignancies: the Italian Hematology Alliance |
| NCT Number | NCT04352556 HM-COVID 19-ITALY |
| Conditions | SARS-CoV-2 Infection Hematological Malignancies |
| Sponsor/Collaborators | Francesco Passamonti, Ospedale di Circolo - Fondazione Macchi |
| Gender | All |
| Age | 18 Years and older (Adult, Older Adult) |
| Phases | |
| Enrollment | 250 participants |
| Study Type | Observational |
| Study Designs | Cohort |
| Start Date | 07/04/2020 |
| Completion Date | 01/10/2022 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa |
| URL | https://www.clinicaltrials.gov/ct2/show/NCT04352556 |
| Title | REFINE: Regorafenib Observational Study in Hepatocellular Carcinoma |
| NCT Number | NCT03289273 |
| Conditions | Intervention/treatment Liver Neoplasms Drug: Regorafenib (Stivarga, BAY73-4506) |
| Sponsor/Collaborators | Bayer |
| Gender | All |
| Age | Child, Adult, Older Adult |
| Phases | |
| Enrollment | |
| Study Type | Observational |
| Study Designs | Cohort |
| Start Date | 13/09/2017 |
| Completion Date | 27/07/2022 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Gastroenterologia ed Epatologia, Prof. Vito Di Marco |
| URL | https://www.clinicaltrials.gov/ct2/show/NCT03289273 |
| Title | Retrospective Observational Study on Dalbavancin Real-life Utilization in Diabetic Patients Suffering From Infections - DALBADIA Study |
| NCT Number |
NCT04959799 146(Z)PO20094 |
| Conditions | Intervention/treatment Diabetes Infection |
| Interventions | Drug: Dalbavancin |
| Sponsor/Collaborators | Aziende Chimiche Riunite Angelini Francesco S.p.A |
| Gender | All |
| Age | 18 Years and older (Adult, Older Adult) |
| Phases | |
| Enrollment | 98 |
| Study Type | Observational |
| Study Designs | Cohort |
| Start Date | 02/01/2022 |
| Completion Date | 31/05/2022 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Malattie Infettive, Prof. Antonio Cascio |
| URL | https://www.clinicaltrials.gov/ct2/show/NCT04959799 |
| Title | A Randomized, Double-Blind, Active-Controlled Phase 3 Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH) |
| NCT Number | NCT03818607 ABP959 |
| Conditions | Paroxysmal Nocturnal Hemoglobinuria |
| Sponsor/Collaborators | Amgen |
| Gender | All |
| Age | 18 Years and older (Adult, Older Adult) |
| Phases | Phase 3 |
| Enrollment | |
| Study Type | Interventional (Clinical Trial) |
| Study Designs | Crossover Assignment |
| Start Date | 24/04/2019 |
| Completion Date | 12/07/2022 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa |
| URL | https://www.clinicaltrials.gov/ct2/show/NCT03818607 |
| Title | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) Studio multicentrico di fase 3, randomizzato, in doppio cieco, controllato verso placebo per valutare l’efficacia, la sicurezza e la tollerabilità di rozanolixizumab in soggetti adulti con trombocitopenia immune primaria (ITP) persistente o cronica |
| EudraCT number | 2019-003451-11 TP-0006 |
| Medical condition | Primary Immune Thrombocytopenia trombocitopenia immune primaria |
| Sponsor/Collaborators | UCB Biopharma SRL |
| Gender | Female; Male |
| Population Age | Adults; Elderly; |
| Phases | Phase III |
| Enrollment | 105 |
| Trial type | Therapeutic confirmatory (Phase III) |
| Design of the trial | Controlled; Randomised; Parallel group; |
| Start Date | 05/04/2020 |
| Completion Date | 05/05/2022 |
| Locations | Germany - A.O.U. Policlinico P. Giaccone Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa |
| URL | https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-003451-11/IT |
| Title | A Multicenter, Non-Interventional Study to Evaluate Physical Activity, Bleeding Incidence and Health Related Quality of Life, in Patients With Haemophilia A Without Inhibitors Receiving Standard of Care Treatment |
| NCT Number | NCT04165135 |
| Conditions | Severe Hereditary Factor VIII Deficiency Disease Without Inhibitor Moderate Hereditary Factor VIII Deficiency Disease Without Inhibitor Haemophilia A |
| Interventions | Drug: Standard of Care for Haemophilia A |
| Sponsor/Collaborators | Hoffmann-La Roche |
| Gender | All |
| Age | 12 Years to 50 Years (Child, Adult) |
| Phases | |
| Enrollment | 107 |
| Study Type | Observational |
| Study Designs | Cohort |
| Start Date | 24/02/2020 |
| Completion Date | 28/04/2022 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa |
| URL | https://www.clinicaltrials.gov/ct2/show/NCT04165135 |
| Title | Evaluate the Efficacy of Sorafenib in Renal Cell Carcinoma Patients After a Radical Resection of the Metastases |
| NCT Number | NCT01444807 |
| Conditions | Metastatic Renal Cell Carcinoma |
| Interventions | Drug: sorafenib |
| Sponsor/Collaborators | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
| Gender | All |
| Age | 18 Years and older (Adult, Older Adult) |
| Phases | Phase 2 |
| Enrollment | 132 |
| Study Type | Interventional |
| Study Designs | Allocation: Randomized|Intervention Model: Single Group Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment |
| Start Date | 01/12/2011 |
| Completion Date | 01/03/2022 |
| Locations | Italy|Vittorio Gebbia, Palermo |
| URL | https://ClinicalTrials.gov/show/NCT01444807 |
| Title | Immunogenicity and Safety of DTaP-IPV-HB-PRP~T Combined Vaccine Given at 3, 5, and 12 Monhs of Age Concomitantly or Sequentially 4CMenB Vaccine in Italian Infants Immunogenicità e sicurezza del vaccino combinato DTaP-IPVHB-PRP~T somministrato a 3, 5 e 12 mesi di età in concomitanza o in sequenza al vaccino 4CMenB a infanti italiani |
| EudraCT number | 2019-002585-12 |
| Medical condition | Haemophilus influenzae type b immunisation Immunizzazione Haemophilus influenzae di tipo B |
| Sponsor/Collaborators | SANOFI PASTEUR |
| Gender | Female; Male |
| Population Age | Infants and toddlers (28 days-23 months); |
| Phases | Phase IV |
| Enrollment | 396 |
| Trial type | Therapeutic use (Phase IV) |
| Design of the trial | Controlled; Randomised; Open; Parallel group; Disegno complesso (vaccino somministrato in concomitanza o in sequenza) Complex design (vaccine administrated concomitantly or sequentially) |
| Start Date | 08/03/2020 |
| Completion Date | 03/11/2021 |
| Locations | Italy - A.O.U. Policlinico P. Giaccone Palermo |
| URL | https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-002585-12/IT |
| Title | The Role of Benralizumab on airway Remodeling Assessed by HRCT in severe asthma (BREATH Study) Il ruolo del Benralizumab sul rimodellamento delle vie aeree nell'asma grave valutato tramite HRCT (Studio BREATH) |
| NCT Number | 2018-002498-23 (EudraCT) - ESR-16-12340 (Sponsor's Protocol Code Number) |
| Conditions | SEVERE ASTHMA |
| Interventions | |
| Sponsor/Collaborators | A.O.U. POLICLINICO “PAOLO GIACCONE” DI PALERMO |
| Gender | All |
| Age | Adults, Elderly |
| Phases | Phase 3 |
| Enrollment | |
| Study Type | Therapeutic confirmatory (Phase III) |
| Study Designs |
Controlled Single-center, randomized, double-bind, placebo-controlled, longitudinal, parallel group study |
| Start Date | 17/07/2019 |
| Completion Date | 17/07/2021 |
| Locations | Prof. Nicola Scichilone, A.O.U. Policlinico P. Giaccone di Palermo |
| URL | https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-002498-23/IT |
| Title | Intestinal preparation with new 1 L Peg + Asc solution or with gold standard 4 L Peg in split dose. Multicenter randomized controlled trial (OVER). Preparazione intestinale con la nuova soluzione 1 L Peg + Asc o con la standard 4 L Peg in split dose. Studio multicentrico randomizzato controllato (OVER). |
| EudraCT number | 2018-004543-24 |
| Medical condition | Screening or surveillance or diagnostic colonoscopy. Colonscopia di screening o sorveglianza o diagnostica. |
| Sponsor/Collaborators | Provincia Religiosa di S.Pietro Ordine Ospedaliero San Giovanni di Dio Fatebenefratelli |
| Gender | Female; Male |
| Population Age | Adults; Elderly; |
| Phases | Phase IV |
| Enrollment | 400 |
| Trial type | Therapeutic use (Phase IV) |
| Design of the trial | Controlled; Randomised; Single blind; Parallel group; |
| Start Date | 29/01/2021 |
| Completion Date | 29/04/2021 |
| Locations | Italy - A.O.U. Policlinico P. Giaccone Palermo |
| URL | https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-004543-24/IT |
| Full Title | A phase II, single-arm, multicenter study of full treatment-free remission in patients with chronic myeloid leukemia in chronic phase treated with nilotinib in first-line therapy who have achieved a sustained deep molecular response for at least 1 year: DANTE study Studio di fase II, multicentrico, con singolo braccio di trattamento, sulla remissione totale libera da trattamento in pazienti con leucemia mieloide cronica in fase cronica trattati con nilotinib in terapia di prima linea che hanno ottenuto una risposta molecolare profonda sostenuta per almeno un anno: studio DANTE |
| EudraCT number | 2018-002898-21 CAMN 107 AIT 15 (DANTE) |
| Medical condition | Patients with chronic myeloid leukemia in chronic phase treated with nilotinib in first-line therapy who have achieved a sustained, deep molecular response for at least 1 year. Pazienti con leucemia mieloide cronica in fase cronica trattati con nilotinib in terapia di prima linea che hanno ottenuto una risposta molecolare profonda sostenuta per almeno un anno. |
| Sponsor/Collaborators | NOVARTIS FARMA S.P.A. |
| Gender | Female; Male |
| Population Age | Adults; Elderly; |
| Phases | Phase II |
| Enrollment | 136 |
| Trial type | Therapeutic exploratory (Phase II) |
| Start Date | 25/10/2018 |
| Completion Date | 23/03/2021 |
| 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/2018-002898-21/IT |
| Full Title | A randomized Phase III study to compare arsenic trioxide (ATO) combined to ATRA and idarubicin versus standard ATRA and anthracycLines-based chemotherapy (AIDA regimen) for patient with newLy diagnosed, high-risk acute prOmyelocytic leukemia A randomized Phase III study to compare arsenic trioxide (ATO) combined to ATRA and idarubicin versus standard ATRA and anthracycLines-based chemotherapy (AIDA regimen) for patient with newLy diagnosed, high-risk acute prOmyelocytic leukemia |
| EudraCT number |
2015-001151-68 TUD-APOLLO-064 |
| Medical condition | Acute promyelocytic leukemia Leucemia promielocitica acuta |
| Sponsor Name | TECHNISCHE UNIVERSITäT DRESDEN |
| Gender | Female; Male |
| Population Age | Adults; |
| Phases | Phase III |
| Enrollment | 280 |
| Trial type | Therapeutic confirmatory (Phase III) |
| Design of the trial | Controlled; Randomised; Open; Parallel group; |
| Start Date | 25/08/2015 |
| Completion Date | 19/02/2021 |
| Locations | Germany Italy - A.O.U. Policlinico P. Giaccone Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa, Dott.ssa Mitra |
| URL | https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-001151-68/IT |
| Full title | Use of Direct Oral Anticoagulants (DOACs) in Patients With Ph-negative Myeloproliferative Neoplasms |
| NCT Number | NCT04192916 |
| Conditions | ntervention/treatment Myeloproliferative Neoplasm Drug: DOACs |
| Sponsor/Collaborators | Fondazione per la Ricerca Ospedale Maggiore |
| Gender | All |
| Age | 18 Years and older (Adult, Older Adult) |
| Phases | Phase 2 |
| Enrollment | 237 participants |
| Study Type | Observational |
| Study Designs | Cohort |
| Start Date | 01/09/2019 |
| Completion Date | 31/12/2020 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa |
| URL | https://www.clinicaltrials.gov/ct2/show/NCT04192916 |
| Title | A SINGLE-ARM, MULTICENTER PHASE IIIB CLINICAL TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF PROPHYLACTIC EMICIZUMAB IN HEMOPHILIA A PATIENTS WITH INHIBITORS STUDIO CLINICO DI FASE IIIB, A SINGOLO BRACCIO, MULTICENTRICO, PER LA VALUTAZIONE DELLA SICUREZZA E DELLA TOLLERABILIT¿ DELLA PROFILASSI CON EMICIZUMAB IN PAZIENTI AFFETTI DA EMOFILIA A CON INIBITORI |
| EudraCT number | 2016-004366-25 NCT03191799 |
| Medical condition | Hemophilia A Emofilia A |
| Sponsor/Collaborators | F. HOFFMANN - LA ROCHE LTD. |
| Gender | Female; Male |
| Population Age | Adolescents (12-17 years); Adults; Elderly; |
| Phases | Phase III |
| Enrollment | 200 |
| Trial type | Therapeutic confirmatory (Phase III) |
| Design of the trial | Controlled; Open; |
| Start Date | 27/07/2017 |
| Completion Date | 26/07/2020 |
| Locations | Switzerland Italy - A.O.U. Policlinico P. Giaccone Palermo, U.O.C. di Ematologia, Prof. Sergio Siragusa |
| URL | https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-004366-25/IT https://www.clinicaltrials.gov/ct2/show/NCT03191799 |
| Title | A double blind, double dummy, multicenter, randomized, placebo- and active-controlled clinical trial to evaluate effectiveness of Tricortin 1000 in patients affected by chronic low back pain Studio clinico multicentrico, randomizzato, in doppio cieco,doppio dummy, controllato verso placebo e verso farmaco attivo, con lo scopo di valutare l'efficacia di Tricortin 1000 in pazienti affetti da LBP cronico |
| EudraCT number | 2018-002003-33 |
| Medical condition | Low Back Pain Lombalgia, lombocruralgia, lombosciatalgia |
| Interventions | |
| Sponsor/Collaborators | FIDIA FARMACEUTICI S.P.A. |
| Gender | Female; Male |
| Population Age | Adults; Elderly; |
| Phases | Phase IV |
| Enrollment | 300 |
| Trial type | Therapeutic use (Phase IV) |
| Design of the trial | Controlled; Randomised; Parallel group; Doppio dummy Double dummy |
| Start Date | 12/12/2018 |
| Completion Date | 11/03/2020 |
| Locations | Italy - A.O.U. Policlinico P. Giaccone Palermo |
| URL | https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-002003-33/IT |
| Title |
Open-label study to evaluate the safety, tolerability, and efficacy of LOmitapide for the treatment of patients with Familial CHylomicroNEmia Syndrome Studio in aperto per valutare sicurezza, tollerabilità ed efficacia di Lomitapide per il trattamento di pazienti affetti da Sindrome Chilomicronemica Familiare |
| NCT Number | 2018-002911-80 (EudraCT) - LOCHNES (Sponsor's Protocol Code Number) |
| Conditions | Familial Chylomicronemia Syndrome Sindrome Chilomicronemica Familiare |
| Interventions | |
| Sponsor/Collaborators | A.O.U. POLICLINICO “PAOLO GIACCONE” DI PALERMO |
| Gender | All |
| Age | Adults, Elderly |
| Phases | Phase 3 |
| Enrollment | |
| Study Type | Therapeutic confirmatory (Phase III) |
| Study Designs |
Studio in aperto |
| Start Date | 18/12/2018 |
| Completion Date | 18/06/2019 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo |
| URL | https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-002498-23/IT |
| Title |
Study to Investigate the Efficacy of elbasvir/grazoprevir Fixed-Dose Combination for 8 Weeks in G1b Treatment-Naive, HCV-Infected Patients With non-severe Fibrosis, with or without glucose abnormalities EGG 18. Studio per valutare l'efficacia del trattamento di Elbasvir/Grazoprevir, in dose fissa combinata, per 8 settimane in pazienti con infezione da HCV Naive al trattamento G1b con fibrosi non severa e con o senza anormalità glucidica e EGG 18 |
| NCT Number | 2017-003710-58 (EudraCT Number) |
| Conditions | Vaccines, Combined Hexavalent Vaccine |
| Interventions | Biological: Vaxelis™ |
| Sponsor/Collaborators | A.O.U. POLICLINICO “PAOLO GIACCONE” DI PALERMO |
| Gender | All |
| Age | Adults, Elderly |
| Phases | Phase 3 |
| Enrollment | 169 |
| Study Type | Therapeutic confirmatory (Phase III) |
| Study Designs | Open |
| Start Date | 17/07/2018 |
| Completion Date | 17/05/2019 |
| Locations |
A.O.U. POLICLINICO “PAOLO GIACCONE” DI PALERMO |
| URL | https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-003710-58/IT |
| Title | Randomized Study of the Treatment of Primary Immune Thrombocytopenic Purpura (ITP) in Newly Diagnosed Untreated Adult Patients. Comparison of Standard Dose Prednisone Versus High-dose Dexamethasone. |
| NCT Number | NCT00657410 |
| Conditions | Nonneoplastic Condition |
| Interventions | |
| Sponsor/Collaborators | Gruppo Italiano Malattie EMatologiche dell'Adulto |
| Gender | All |
| Age | 18 Years to 80 Years (Adult, Older Adult) |
| Phases | Phase 3 |
| Enrollment | |
| Study Type | Interventional (Clinical Trial) |
| Study Designs | Parallel Assignment |
| Start Date | 14/04/2008 |
| Completion Date | 20/02/2017 |
| Locations | A.O.U. Policlinico P. Giaccone di Palermo - Divisione di Ematologia con trapianto di midollo - prof. Sergio Siragusa |
| URL | https://www.clinicaltrials.gov/ct2/show/NCT00657410 |
|
Title |
Metabolic Effects of Furosemide +HSS in Refractory Ascites |
| NCT Number | NCT02821377 |
| Conditions | Ascites|Cirrhosis |
| Interventions | Drug: intravenous furosemide|Drug: Hypertonic saline solutions|Procedure: Seriated paracentesis |
| Sponsor/Collaborators | University of Palermo |
| Gender | All |
| Age | 18 Years to 80 Years (Adult, Older Adult) |
| Phases | Phase 2 |
| Enrollment | 40 |
| Study Type | Interventional |
| Study Designs | Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| Start Date | 01/12/2013 |
| Completion Date | 01/04/2016 |
| Locations | Antonino Tuttolomondo, Palermo, Italy|Internal Medicine Ward of Palermo University Hospital, Palermo, Italy|Internal Medicine Ward, University of Palermo, Palermo, Italy |
| URL | https://ClinicalTrials.gov/show/NCT02821377 |
| Title | Nickel Allergy and Systemic Nickel Allergy Syndrome in Non Celiac Wheat Sensitivity |
| NCT Number | NCT02750735 |
| Conditions | Non Celiac Wheat Sensitivity |
| Interventions | |
| Sponsor/Collaborators | University of Palermo |
| Gender | All |
| Age | 18 Years and older (Adult, Older Adult) |
| Phases | |
| Enrollment | 200 |
| Study Type | Observational |
| Study Designs | Observational Model: Case-Only |
| Start Date | 01/01/2001 |
| Completion Date | 01/03/2016 |
| Locations | Antonio Carroccio, Sciacca, Agrigento, Italy|Pasquale Mansueto, Palermo, Italy |
| URL | https://ClinicalTrials.gov/show/NCT02750735 |
| Title | Nickel Allergy and Systemic Nickel Allergy Syndrome in Non Celiac Wheat Sensitivity |
| NCT Number | NCT02750735 |
| Conditions | Non Celiac Wheat Sensitivity |
| Interventions | |
| Sponsor/Collaborators | University of Palermo |
| Gender | All |
| Age | 18 Years and older (Adult, Older Adult) |
| Phases | |
| Enrollment | 200 |
| Study Type | Observational |
| Study Designs | Observational Model: Case-Only |
| Start Date | 01/01/2001 |
| Completion Date | 01/03/2016 |
| Locations | Antonio Carroccio, Sciacca, Agrigento, Italy|Pasquale Mansueto, Palermo, Italy |
| URL | https://ClinicalTrials.gov/show/NCT02750735 |
| Title | Fermented Milk on the Appearance of Common Winter Infectious Diseases |
| NCT Number | NCT02367612 |
| Conditions | Acute Gastroenteritis|Upper Respiratory Tract Infections |
| Interventions | Dietary Supplement: Fermented milk|Dietary Supplement: Placebo |
| Sponsor/Collaborators | Federico II University |
| Gender | All |
| Age | 12 Months to 48 Months (Child) |
| Phases | Phase 2 |
| Enrollment | 140 |
| Study Type | Interventional |
| Study Designs | Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Prevention |
| Start Date | 01/12/2014 |
| Completion Date | 01/06/2015 |
| Locations | Fabio Mosca, Milan, Italy|university of naples federico II, Naples, Italy|Giovanni Corsello, Palermo, Italy |
| URL | https://ClinicalTrials.gov/show/NCT02367612 |
| Title | Troponin I Release After High Diuretic Doses |
| NCT Number | NCT01419132 |
| Conditions | ADHF |
| Interventions | Drug: Furosemide |
| Sponsor/Collaborators | University of Palermo |
| Gender | All |
| Age | 18 Years to 95 Years (Adult, Older Adult) |
| Phases | Phase 4 |
| Enrollment | 60 |
| Study Type | Interventional |
| Study Designs | Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment |
| Start Date | 01/08/2011 |
| Completion Date | 01/09/2011 |
| Locations | Department of Internal and Specialty Medicine, Palermo, Italy|Gaspare Parrinello, Palermo, Italy|GF Ingrasasia Hospital, Palermo, Italy |
| URL | https://ClinicalTrials.gov/show/NCT01419132 |
| Title | Absence of Residual Vein Thrombosis Permits to Withdrawn Oral Anticoagulants |
| NCT Number | NCT00623987 |
| Conditions | Deep Vein Thrombosis |
| Interventions | Drug: warfarin accordingly INR value |
| Sponsor/Collaborators | Azienda Ospedaliera Universitaria Policlinico |
| Gender | All |
| Age | 18 Years and older (Adult, Older Adult) |
| Phases | Phase 4 |
| Enrollment | 500 |
| Study Type | Interventional |
| Study Designs | Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| Start Date | 01/06/1999 |
| Completion Date | 01/01/2008 |
| Locations | Sergio Siragusa, Palermo, Italy |
| URL | https://ClinicalTrials.gov/show/NCT00623987 |