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Trial conclusi

13-dic-2022

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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
Randomised
Double blind
Parallel group

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
Open Label
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