acronym: MARIPOSA

title: A Phase 3, Randomized Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib Versus Lazertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer.

ReferenceCitation: Cho BC, Felip E, Hayashi H, Thomas M, Lu S, Besse B, Sun T, Martinez M, Sethi SN, Shreeve SM, Spira AI. MARIPOSA: phase 3 study of first-line amivantamab + lazertinib versus osimertinib in EGFR-mutant non-small-cell lung cancer. Future Oncol. 2022 Feb;18(6):639-647. doi: 10.2217/fon-2021-0923. Epub 2021 Dec 16.

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical- trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
Poland
Portugal
Russian Federation
Australia
Argentina
Puerto Rico
India
Israel
Turkey
Mexico
Malaysia
Brazil
Canada
Hungary
China
Germany
Taiwan
Thailand
Korea, Republic of
France
Netherlands

location_facility: Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie

location_facility: Washington University School of Medicine

location_facility: UPCO Unidade de Pesquisa Clinica em Oncologia

location_facility: Orszagos Koranyi Tbc es Pulmonologiai Intezet

location_facility: Tianjin Medical University General Hospital

location_facility: Private Specialist Hospitals - MedPolonia

location_facility: Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4

location_facility: Fundação Antônio Prudente - A.C. Camargo Cancer Center

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH

location_facility: Fundação Faculdade de Medicina - Instituto do Cancer do Estado de São Paulo

location_facility: The Second Affiliated Hospital of Zhejiang University College of Medicine

location_facility: IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado

location_facility: União Brasileira de Educação e Assistência-Hospital São Lucas da PUCRS

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: Thoraxklinik am Universitätsklinikum Heidelberg

location_facility: Grand Hôpital de Charleroi, site Notre Dame

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Centrum Onkologii im. Prof. F. Lukaszczyka

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktatokorhaz

location_facility: Mexico Centre for Clinical Research, S.A. de C.V.

location_facility: Hospital Evangélico de Cachoeiro de Itapemirim

location_facility: Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal

location_facility: National Hospital Organization Iwakuni Clinical Center

location_facility: Hospital Privado Centro Medico de Cordoba

location_facility: Nizhny Novgorod Regional Oncological Dispensary

location_facility: Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'

location_facility: Second Affiliated Hospital, School of Medicine, Zhejiang University

location_facility: Centro Hospitalar Universitario do Porto, EPE

location_facility: TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology

location_facility: Başkent University Medical Faculty Adana Application and Research Center

location_facility: Centro Oncologico Riojano Integral (Cori)

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Municipal non-profit enterprise 'Regional Center of Oncology'

location_facility: Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda

location_facility: Oncology Medical Clinics AV Medical group

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: Ministerio da Saude - Instituto Nacional do Cancer

location_facility: CIMOVA, Morals Vargas Centro de Investigación SC

location_facility: Pan American Center for Oncology Trials LLC

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Severance Hospital, Yonsei University Health System

location_facility: N.N. Petrov Research Institute Of Oncology

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: National Hospital Organization Yamaguchi Ube Medical Center

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Shengjing Hospital of China Medical University

location_facility: Sun Yat-Sen Memorial Hospital Sun Yat-sen University

location_facility: The First Affiliated Hospital, Sun Yat-sen University

location_facility: The First People's Hospital Of Changzhou

location_facility: Tambov Regional Oncology Clinical Dispansary

location_facility: Instituto D'Or de Pesquisa e Ensino (IDOR)

location_facility: Cancer Hospital of Xinjiang Medical University

location_facility: Seoul National University Bundang Hospital

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: Yaroslavl Regional Clinical Oncology Hospital

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd

location_facility: National Hospital Organization Shibukawa Medical Center

location_facility: Centro Hospitalar Lisboa Norte EPE - Hospital Pulido Valente

location_facility: Nottingham University Hospitals NHS Trust

location_facility: T.C. Saglik Bakanlıgi Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi

location_facility: Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Beijing Chest hospital, Capital medical university

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: Harbin medical university cancer hospital

location_facility: Beijing Friendship Hospital, Capital Medical University

location_facility: Necmettin Erbakan University Meram Medical Faculty

location_facility: Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken München-Gauting

location_facility: Ruijin Hospital, Shanghai Jiao Tong University

location_facility: Krasnoyarsk Regional Oncology Dispensary

location_facility: Phramongkutklao Hospital and Medical College

location_facility: Ospedale San Giuseppe Moscati di Avellino

location_facility: National Hospital Organization Osaka Toneyama Medical Center

location_facility: Songklanagarind Hospital, Prince of Songkla University

location_facility: Taipei Medical University Shuang Ho Hospital

location_facility: Robert-Bosch-Krankenhaus - Klinik Schillerhoehe

location_facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

location_facility: National Hospital Organization Himeji Medical Center

summary: The purpose of this study is to assess the efficacy of the amivantamab and lazertinib combination, compared with osimertinib, in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions [Exon 19del] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).


type: Registry Identifier

type: EudraCT Number

title: A Phase 1/2, Multicenter, Open-label Study to Assess Safety, Pharmacokinetics, and Preliminary Efficacy of CC-220, Alone and in Combination With an Anti-CD20 Monoclonal Antibody (mAb) in Subjects With Relapsed or Refractory Lymphomas.

summary:
This Phase 1/2, multicenter, open-label study to evaluate CC-220 alone, as well as in combination with an anti-CD20 mAb (rituximab or obinutuzumab) in subjects with relapsed or refractory (R/R) lymphoma. Subjects must have received at least 2 prior lines of therapy, and have at least one measurable lesion according to Lugano 2014 classification.

Study will consist of two parts: Part 1 (Dose Escalation) which will be followed by Part 2 (Dose Expansion).

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

lead_sponsor: Celgene

location_country:
Taiwan
Italy
Korea, Republic of
United States
France
Germany

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Charite - Universitaetsmedizin Berlin Charité - Campus Benjamin Franklin

location_facility: AO di Rilievo Nazionale e di Alta Secializzazione Garibaldi

location_facility: Chang Gung Memorial Hospital - Kaohsiung

location_facility: Weill Cornell Medical College - New York Presbyterian Hospital

location_facility: A.O.U. di Bologna Policlinico S.Orsola-Malpighi

location_facility: AOU Integrata Verona - Ospedale Policlinico Giambattista Rossi di Borgo Roma

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase 3 Multicenter, Randomized, Double Masked, Sham- Controlled Clinical Trial to Assess the Safety and Efficacy of Intravitreal Administration of Zimura (Complement C5 Inhibitor) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

summary: The objectives of this study are to evaluate the safety and efficacy of Zimura intravitreal administration in patients with geographic atrophy secondary to age-related macular degeneration (AMD)

status: Active, not recruiting

design_allocation: Randomized

enrollment_type: Actual

lead_sponsor: IVERIC bio, Inc.

location_country:
Croatia
Poland
Brazil
Spain
Colombia
Austria
Australia
Estonia
Argentina
Canada
Italy
Latvia
Hungary
United States
France
Israel
Belgium
Germany
Czechia

location_facility: Northern California Retina Vitreous Associates

location_facility: Centro de Diagnóstico y Cirugía Ocular "Oftalmólogos Especialistas"

location_facility: Organización Médica de Investigación S.A.

location_facility: Medizinische Universitaet Innsbruck - Universitaetsklinik fuer Augenheilkunde und Optometrie

location_facility: Azienda Sanitaria Universitaria Integrata

location_facility: Centre Ophtalmologique d'Imagerie et de Laser

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Retina-Vitreous Associates Medical Group

location_facility: Szabolcs-Szatmar-Bereg County Hospital and University Teaching Hospital

location_facility: Retina Research Institute at New England Retinal Consultants

location_facility: Debrecen University Clinical Center, Dept of Ophthalmology

location_facility: Retina Consultants of Southern California

location_facility: Fundacion OJlalmologica Nacional - FUNDONAL

location_facility: Semmelweis University, Dept of Ophthalmology

location_facility: Azienda Ospedaliero Universitaria di Ferrara

location_facility: AOU Universita degli Studi della Campania Luigi Vanvitelli UOC Oculistica

location_facility: Scheie Eye Institute, University of Pennsylvania

location_facility: University of Bonn, Dept of Ophthalmology

location_facility: Canadian Centre for Advanced Eye Therapeutics Inc.

location_facility: Medizinische Universitaet Graz - Augenklinik

location_facility: Nuovo Arcispedale Sant' Anna (A.O.U. di Ferrara)

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego

location_facility: Markusovszky Egyetemi Oktatokorhaz Szerneszeti Osztalya

location_facility: University of Utah, John A. Moran Eye Center

location_facility: Department of Ophthalmology, Rabin Medical Center

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Centro Medico Micro Diagnostico y Microcirugla Ocular

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Retina and Vitreous Center of Southern Oregon

location_facility: Instituto Clinico Quirurgico de Oftalmologia

location_facility: Southern California Desert Retina Consultants

location_facility: Centro Privado de Oftalmologia - OFTAR Mendoza SRL

location_facility: Pauls Stradinis Clinical University Hospital

location_facility: Klinika Okulistyczna OFT ALMIKA Sp. z o. o.

location_facility: Azienda Ospedaliera di Padova Unità Operativa Complessa di Clinica Oculistica

location_facility: Magyar Honvedseg EgeszsegUgyi Kozpont. Szemeszeti Osztaly

location_facility: Jules Stein Eye Institute/David Geffen School of Medicine

location_facility: Centre d'exploration ophtalmologique de l'Odeon

location_facility: Retina Vitreous Surgeons of Central New York, PC

location_facility: Ospedale Clinicizzato Universita di Chieti "Ss Annunziata"

location_facility: Retina Consultants of Southern Colorado, P.C.


title: A Global Multicenter Randomized Placebo-Controlled Phase 3 Trial To Compare The Efficacy And Safety Of Fruquintinib Plus Best Supportive Care To Placebo Plus Best Supportive Care In Patients With Refractory Metastatic Colorectal Cancer

summary: This is a global, randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial to compare the efficacy and safety of fruquintinib plus best supportive care (BSC) versus placebo plus BSC in patients with refractory metastatic colorectal cancer (mCRC). 691 patients were randomized to one of the following treatment arms in a 2:1 ratio, fruquintinib plus BSC or placebo plus BSC.

ReferenceType: derived

ReferenceCitation: Dasari A, Sobrero A, Yao J, Yoshino T, Schelman W, Yang Z, Chien C, Kania M, Tabernero J, Eng C. FRESCO-2: a global Phase III study investigating the efficacy and safety of fruquintinib in metastatic colorectal cancer. Future Oncol. 2021 Aug;17(24):3151-3162. doi: 10.2217/fon-2021-0202. Epub 2021 May 17.

ipd_sharing: No

lead_sponsor: Hutchison Medipharma Limited

location_country:
Poland
Spain
Italy
Austria
Australia
Estonia
United Kingdom
Hungary
United States
France
Belgium
Japan
Germany
Czechia

location_facility: Tartu University Hospital Clinic of Haematology and Oncology

location_facility: Sarah Cannon Research Institute-Pan-Tallahassee (FCS Panhandle)

location_facility: Ordensklinikum Linz Barmherzige Schwestern

location_facility: Medical College of Wisconsin/ Froedtert Hospital

location_facility: Zentrum für Hämatologie und Onkologie MVZ GmbH

location_facility: Hospital General Universitario Gregorio Maranon HGUGM

location_facility: Bekes Megyei Kozponti Korhaz, Pandy Kalman Tagkorhaz, Megyei Onkologiai Kozpont

location_facility: Sihtasutus Pohja-Eesti Regionaalhaigla (PERH) (North Estonia Medical Centre)

location_facility: Zala Megyei Szent Rafael Korhaz, Onkologiai Osztaly, F epulet 3. em.

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Vseobecna Fakultni Nemocnice VFN, Onkologicka Klinika

location_facility: East Tallinn Central Hospital Centre of Oncology

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Centre Hospitalier Universitaire CHU de Rennes - Hopital de Pontchaillou

location_facility: City of Hope Comprehensive Cancer Center

location_facility: Haematologisch-Onkologische Praxis Hamburg Eppendorf

location_facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

location_facility: CHU de Lige - Domaine Universitaire du Sart Tilman

location_facility: Institut de cancerologie Strasbourg-Europe

location_facility: Integrated Clinical Oncology Network Pty Ltd (Icon)

location_facility: Bialostockie Centrum Onkologii im. Marii Skodowskiej-Curie

location_facility: Szabolcs-Szatmar-Bereg megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Masaryk Memorial Cancer Institute, Hematoonkologie

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Del-Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet, Szent Laszlo Korhaz

location_facility: XCancer / New Mexico Oncology & Hematology Consultants

location_facility: Wiener Gesundheitsverbund - Klinik Ottakring

location_facility: Institut fr Klinisch Onkologische ForschungKrankenhaus Nordwest GmbH

location_facility: The George Washington University Medical Center

location_facility: M Sklodowska Curie Memorial Cancer Center, Klinika Gastroenterologii Onkologicznej

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: Ospedale San Bortolo Azienda ULSS8 Berica - Distretto Est

location_facility: Universitaetsmedizin Mannheim- III. Medizinische Klinik

location_facility: Onze-Lieve-Vrouwziekenhuis OLV - Campus Aalst

location_facility: Fakultni nemocnice Olomouc, Onkologicka klinika

location_facility: University of Louisville - James Brown Cancer Center

location_facility: Sarah Cannon Research Institute-S-Ft. Myers (FCS South)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Hospital ClÃ-nico Universitario de Santiago-CHUS

location_facility: Asklepios Tumorzentrum Hamburg AK Altona

location_facility: Hospital Universitario Central de Asturias

location_facility: Sarah Cannon Research-E-WPB (Florida Cancer Specialists-FCS East)

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz, Klinikai Onkologiai Osztaly

location_facility: Sarah Cannon Research Institute-N-St Pete (FCS North)


title: ENHANCE: A Randomized, Double-blind, Multicenter Study Comparing Magrolimab in Combination With Azacitidine Versus Azacitidine Plus Placebo in Treatment-naïve Patients With Higher Risk Myelodysplastic Syndrome

acronym: ENHANCE

summary: The primary objective of this study is to evaluate the efficacy of magrolimab in combination with azacitidine compared to that of azacitidine plus placebo in previously untreated participants with intermediate/high/very high risk myelodysplastic syndrome (MDS) by Revised International Prognostic Scoring System (IPSS-R) as measured by complete remission (CR) and overall survival (OS).

lead_sponsor: Gilead Sciences

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Turkey
Norway
Canada
Switzerland
Hungary
Germany
New Zealand
Finland
France
Netherlands

location_facility: University of Arkansas for Medical Sciences IRB

location_facility: University of North Carolina at Chapel Hill

location_facility: Petz Aladar Egyetemi Oktato Korhaz II. Belgyogyaszat - Hematologial Osztaly

location_facility: Centro Hospitalar Universitario Sao Joao. E.P.E

location_facility: The University of Chicago Medical Center

location_facility: U.O.C Ematologia - Dipartimento di Medicina Interna, Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

location_facility: Semmelweis Egyetem Belgyógyászati és Hematológiai Kilnika

location_facility: University of Minnesota Medical Center, Fairview

location_facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: Tekirdag Namik Kemal Universitesi Tip Fakultesi

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: S. C. Ematologia Azienda Ospedaliero - Universitaria Maggiore Della Carita

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Columbia University Medical Center - Herbert Irving Pavilion

location_facility: SC di Oncoematologia - Azienda Ospedaliera Santa Maria

location_facility: Huntsman Cancer Institute/University of Utah

location_facility: The Ohio State University Wexner Medical Center / James Cancer Hospital

location_facility: Marien hospital, klinik fur onkologie, hamatologie und palliavmedizin

location_facility: Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center

location_facility: Centro Clinico Academico de Braga, Hospital de Braga, E.P.E

location_facility: Weill Cornell Medicine-New York Presbyterian Hospital

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord

location_facility: The Chinese University of Hong Kong, Prince of Wales Hospital

location_facility: Hospital of the University of Pennsylvania

location_facility: University of Miami Hospital and Clinics / Sylvester Comprehensive Cancer Center

location_facility: Istituto Oncologico Della Svizzera Italiana- IOSI, EOC, Clinica di Ematologia

location_facility: Haukeland Universitetssjukehus, seksjon for blodsjukdommar- klinisk studieteam

location_facility: Complejo Asistencial Universitario de Salamanca- Hospital Clinico Universitario de Salamanca

location_facility: Hospital Universitario Quironsalud Madrid. Servico de Hematologica y Hemoterapia

location_facility: U.O Ematologica- ASST degli Spedali Civili di Brescia

location_facility: Texas Oncology - Baylor Charles A. Simmons Cancer Center

location_facility: Barwon Health, University Hospital Geelong

location_facility: University of Oklahoma Health Sciences Center

location_facility: Hospital Universitario La Paz, Edificio General, 6 Planta. Despacho de Hematologia

location_facility: U.O di Ematologia, Ospedale San Gerardo- ASST Monza

location_facility: Centro Hospitalar Vila Nova de Gaia/Espinho

location_facility: Hanusch kranhenkaus, 3. Medizinische Abteilung

location_facility: Centro Hospitalar Universitario Sao Joao

location_facility: Universitaetsspital Zurich - Klinik fur Medizinische Onkologie und Hematologie

location_facility: Fakultni nemocnice Ostrava, Klinika hemato-onkologicka

location_facility: Dokuz Eylul Universitesi Tip Fakultesi Onkoloji Enstitusu

location_facility: Froedtert Hospital & the Medical College of Wisconsin

location_facility: Kent and Canterbury Hospital- East Kent Hospitals University NHS Foundation Trust

location_facility: Universitatsmedizin der Johannes Gutenberg Universitat Mainz, III. Medizinische Klinik und Poliklinik

location_facility: University of Kansas Clinical Research Center

location_facility: Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Hospital Regional Universitario de Malaga

location_facility: Thomas Jefferson University, Sidney Kimmel Cancer Center; Clinical Research Organization

location_facility: SC Ematologica, ASST Sette Laghi, Ospedale di Circolo e Fondazione Macchi

location_facility: Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli

location_facility: Washington University School of Medicine - Siteman Cancer Center

location_facility: Institut Catala d'Oncologia, Hospital Duran i Reynals

location_facility: Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

location_facility: University of Maryland, Greenebaum Comprehensive Cancer Center

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: University of California, Davis Comprehensive Cancer Center

location_facility: CHU de Poitiers - Hopital de la Miletrie

location_facility: Oregon Health & Science University Pharmacy Services

location_facility: OSI Araba, Hospital Universitario de Alava, Hospital Txagorritxu

location_facility: Fakultni nemocnice Olomouc, Hemato-onkologicka klinika

location_facility: SC Ematologica- Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo

location_facility: Robert-Bosch-Krankenhaus, GmBH, Hamatologie, Onkologie und Palliativmedizin

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Hematologii

location_facility: Area Sanitaria de Santiago de Compostela y Barbanza. Complejo Hospitalario Universitario de SantiagoD

intervention_type: Biological


acronym: AcceleRET-Lung

title: A Phase III, Randomized, Open-Label Study of Pralsetinib Versus Standard of Care for First-Line Treatment of RET Fusion-Positive, Metastatic Non-Small Cell Lung Cancer

lead_sponsor: Hoffmann-La Roche

source: euctr

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Spain
Italy
United Kingdom
United States
Costa Rica
Belgium
Japan
Poland
Portugal
Australia
Israel
Panama
Turkey
Mexico
Norway
Sweden
Canada
Switzerland
Germany
Denmark
Ireland
New Zealand
Finland
Korea, Republic of
France
Netherlands

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Klinikum der Universität München; Campus Großhadern; Med. Klinik und Poliklinik V

location_facility: UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

location_facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

location_facility: Hospital Univ. Central de Asturias; Servicio de Oncologia

location_facility: Helsinki University Central Hospital; Dept of Oncology

location_facility: Hôpital Louis Pradel, Hospices Civils de Lyon

location_facility: Institut Paoli Calmettes; Oncologie Medicale

location_facility: Institut Jules Bordet; Pulmonary Oncology

location_facility: Karolinska Universitetssjukhuset, Solna; Kliniska prövningsenheten Z:4:01

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

location_facility: CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique

location_facility: Università degli Studi della Campania Luigi Vanvitelli

location_facility: Hospital General Universitario de Valencia; Servicio de oncologia

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: COI Centro Oncologico Internacional SAPI de CV

location_facility: CHRU Lille Service de Pneumologie et Oncologie Thoracique

location_facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center

location_facility: Hôpital Ambroise Paré - Boulogne-Billancourt

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

location_facility: Oslo universitetssykehus HF, Ullevål, Kreftsenteret

location_facility: Hemato Oncología de Panamá Especializada

location_facility: Rigshospitalet, Onkologisk Klinik; Klinisk Forskningsenhed

location_facility: Hosp Clinico Univ Lozano Blesa; División De Oncología Médica

location_facility: Hospital de Braga; Serviço de Pneumologia

location_facility: University of Texas Health Science Center

location_facility: Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare

location_facility: Klinik Schillerhöhe; Pneumologische Onkologie

location_facility: Pius-Hospital; Klinik fuer Haematologie und Onkologie

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Institut universitaire de cardiologie et de pneumologie de Québec (Hôpital Laval)

location_facility: Hopital Bichat Claude Bernard; Oncologie Serv.

location_facility: Hospital Garcia de Orta; Servico de Pneumologia

location_facility: Centro Hospitalar de Vila Nova de Gaia / Espinho E.P.E

location_facility: University College Hospital; Department of Oncology

location_facility: Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers

location_facility: Sylvester Comprehensive Cancer Center; University of Miami School of Medicine

location_facility: Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica

location_facility: IRCCS Giovanni Paolo II Istituto Oncologico

location_facility: Guys & St Thomas Hospital; Department of Oncology

location_facility: Millennium Research & Clinical Development

location_facility: Hospital Regional Universitario de Malaga

location_facility: Royal North Shore Hospital; Department of Medical Oncology

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Hopital de Pontchaillou; Service de Pneumologie

location_facility: Sourasky / Ichilov Hospital; Dept. of Oncology

location_facility: AZ. Ospedaliera San Giovanni - Addolorata

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: Shaare Zedek Medical Center; Oncology Dept

location_facility: National Hospital Organization Yamaguchi - Ube Medical Center

location_facility: Auckland City Hospital, Cancer and Blood Research

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Leopoldina-Krankenhaus Medizinische Klinik II

location_facility: Universitätsklinikum Carl Gustav Carus, Medizinische Klinik I, Pneumologie MK1-A13

location_facility: Leicester Royal Infirmary; Dept. of Medical Oncology

location_facility: Medipol Mega Üniversite Hastanesi Göztepe

location_facility: University of Maryland Marlene and Stewart Greenebaum Cancer Center

location_facility: Adana Baskent University Hospital; Medical Oncology

location_facility: A.O.U. INTEGRATA DI VERONA-Ospedale Civile Maggiore Borgo Trento; U.O.C. Oncologia

location_facility: National Hospital Organization Himeji Medical Center

location_facility: Hospital Universitario Germans Trias i Pujol

summary: This is an international, randomized, open-label, Phase 3 study designed to evaluate whether the potent and selective RET inhibitor, pralsetinib, improves outcomes when compared to a platinum chemotherapy-based regimen chosen by the Investigator from a list of standard of care treatments, as measured primarily by progression free survival (PFS), for participants with RET fusion-positive metastatic NSCLC who have not previously received systemic anticancer therapy for metastatic disease. Participants who have centrally confirmed progressive disease on the control arm have the option to crossover to pralsetinib.


title: A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Plus ADT Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (KEYNOTE-991)

lead_sponsor: Merck Sharp & Dohme LLC

type: Other Identifier

location_country:
Spain
Italy
United Kingdom
United States
Peru
Japan
Poland
Austria
Australia
Russian Federation
Israel
Turkey
Mexico
Brazil
Canada
Switzerland
China
Germany
Denmark
Taiwan
Ireland
New Zealand
Finland
Thailand
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: Ordensklinikum Linz GmbH Elisabethinen ( Site 0901)

location_facility: Vrije Universiteit Medisch Centrum ( Site 1601)

location_facility: Royal Marsden NHS Foundation Trust ( Site 1318)

location_facility: Zhejiang Provincial People's Hospital ( Site 0809)

location_facility: Hacettepe Universitesi Tıp Fakultesi ( Site 2105)

location_facility: Institucion Prestadora de Servicios de Salud Clinica de la Costa LTDA ( Site 2504)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1810)

location_facility: Carolina Urologic Research Center ( Site 0259)

location_facility: Szpital Uniwersytecki nr 1 im. Dr. Antoniego Jurasza w Bydgoszczy ( Site 1720)

location_facility: Hospital Virgen de la Macarena ( Site 1904)

location_facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud ( Site 1102)

location_facility: Istituto Nazionale dei Tumori ( Site 1510)

location_facility: Hospital Universitario Lucus Augusti ( Site 1905)

location_facility: Hospital de Clinicas de Porto Alegre ( Site 2304)

location_facility: Radomskie Centrum Onkologii ( Site 1701)

location_facility: Nippon Medical School Hospital ( Site 0738)

location_facility: Hadassah Ein Kerem Medical Center ( Site 1404)

location_facility: Saitama Medical University International Medical Center ( Site 0737)

location_facility: Taipei Veterans General Hospital ( Site 0501)

location_facility: Universitaetsklinikum Magdeburg A.o.R. ( Site 1211)

location_facility: Nasz Lekarz Przychodnie Medyczne ( Site 1718)

location_facility: Velindre Cancer Centre Hospital ( Site 1322)

location_facility: Clinica Peruano Americana S.A. ( Site 2702)

location_facility: Szpital Uniwersytecki w Krakowie ( Site 1707)

location_facility: CHU de Brest -Site Hopital Morvan ( Site 1103)

location_facility: Instituto Catalan de Oncologia - ICO ( Site 1901)

location_facility: Omsk Clinical Oncology Dispensary ( Site 1809)

location_facility: Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Pozna

location_facility: Universitaetsklinikum Freiburg ( Site 1200)

location_facility: Comprehensive Cancer Centers of Nevada ( Site 0269)

location_facility: Weill Cornell Medical College ( Site 0263)

location_facility: Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 2102)

location_facility: The First Affiliated Hospital of Wenzhou Medical University ( Site 0834)

location_facility: Centro Investigación del Cáncer James Lind ( Site 2401)

location_facility: Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 1717)

location_facility: Azienda Ospedaliera Cannizzaro ( Site 1501)

location_facility: Centro Estatal de Cancerologia de Chihuahua ( Site 2608)

location_facility: Centre D Oncologie de Gentilly ( Site 1107)

location_facility: Centro Oncologico Internacional. SEDNA ( Site 2609)

location_facility: Institut Jean Godinot-Clinical Research Unit ( Site 1118)

location_facility: St Vincents University Hospital ( Site 1300)

location_facility: A.O. Verona-Ospedale Civile Maggiore Borgo-Trento ( Site 1504)

location_facility: Seoul National University Hospital ( Site 0405)

location_facility: CISSS de la Monteregie-Centre ( Site 0105)

location_facility: Szpital Wojewodzki im. Mikolaja Kopernika ( Site 1709)

location_facility: IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 1509)

location_facility: Centre Georges Francois Leclerc ( Site 1112)

location_facility: Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 2706)

location_facility: Chulalongkorn Hospital, Medical Oncology Unit ( Site 0600)

location_facility: Odense Universitetshospital ( Site 1003)

location_facility: Aalborg Universitetshospital ( Site 1000)

location_facility: Gallipoli Medical Research Foundation ( Site 0309)

location_facility: Volga District Medical Center Federal Medical and Biological Agency ( Site 1805)

location_facility: CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0101)

location_facility: Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 2700)

location_facility: St. Vincent Frontier Cancer Center-Research ( Site 0213)

location_facility: Hospital Clinico San Carlos ( Site 1906)

location_facility: Winship Cancer Institute of Emory University ( Site 0209)

location_facility: Faculty of Medicine Siriraj Hospital ( Site 0602)

location_facility: Springfield Clinic [Springfield, IL] ( Site 0240)

location_facility: City of Hope Medical Center ( Site 0217)

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0270)

location_facility: Tokyo Women's Medical University Hospital ( Site 0739)

location_facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 2509)

location_facility: University Hospital Waterford ( Site 1303)

location_facility: Seattle Cancer Care Alliance ( Site 0258)

location_facility: Hartford HealthCare Medical Group ( Site 0212)

location_facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 1212)

location_facility: Fundacao Dr Amaral Carvalho ( Site 2302)

location_facility: Pontificia Universidad Catolica de Chile ( Site 2402)

location_facility: The Sidney Kimmel Comprehensive Cancer Center ( Site 0204)

location_facility: Kitasato University Hospital ( Site 0734)

location_facility: Hospital Nacional Guillermo Almenara Irigoyen ( Site 2708)

location_facility: Hospital Universitario Ramon y Cajal ( Site 1902)

location_facility: Clinica de Oncologia Reichow ( Site 2308)

location_facility: Sociedad Medica Aren y Bachero Limitada ( Site 2403)

location_facility: John Flynn Hospital & Medical Centre ( Site 0308)

location_facility: Instituto Nacional de Cancerologia E.S.E ( Site 2506)

location_facility: Universitaetsklinikum der Technischen Universitaet Dresden ( Site 1204)

location_facility: Associated Medical Professionals of NY ( Site 0251)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0109)

location_facility: Tri-State Urologic Services PSC, Inc. ( Site 0253)

location_facility: Alaska Clinical Research Center ( Site 0274)

location_facility: Kaohsiung Chang Gung Memorial Hospital ( Site 0504)

location_facility: Hospital Sao Vicente de Paulo ( Site 2303)

location_facility: Riverina Cancer Care Center ( Site 0302)

location_facility: Toho University Sakura Medical Center ( Site 0732)

location_facility: Krankenhaus der Barmherzigen Brüder Wien ( Site 0904)

location_facility: Klinikum der Universitaet Muenchen - Grosshadern ( Site 1210)

location_facility: Kyungpook National University Chilgok Hospital ( Site 0404)

location_facility: Instituto de Cancer e Transplante de Curitiba ICTR ( Site 2306)

location_facility: Providence Alaska Medical Center ( Site 0276)

location_facility: Russian Scientific Center of Roentgenoradiology ( Site 1800)

location_facility: Hospital 12 de Octubre de Madrid ( Site 1903)

location_facility: Niagara Health System - St. Catharines ( Site 0107)

location_facility: Severance Hospital Yonsei University Health System ( Site 0402)

location_facility: Centro Di Riferimento Oncologico ( Site 1511)

location_facility: National Taiwan University Hospital ( Site 0500)

location_facility: Osaka City University Hospital ( Site 0741)

location_facility: Universitaetsspital Zuerich ( Site 2001)

location_facility: Smilow Cancer Center at Yale-New Haven ( Site 0250)

location_facility: Landeskrankenhaus Salzburg - Universitatklinikum der PMU ( Site 0900)

location_facility: Franciscus Gasthuis en Vlietland ( Site 1605)

location_facility: Keski-Suomen keskussairaala ( Site 1017)

location_facility: Hamamatsu University Hospital ( Site 0748)

location_facility: Isala Klinieken, Locatie Sophia ( Site 1604)

location_facility: Azienda Ospedaliera Santa Maria ( Site 1502)

location_facility: Urology Associates [Nashville, TN] ( Site 0233)

location_facility: Seoul National University Bundang Hospital ( Site 0401)

location_facility: SBIH City clinical hospital named after D.D. Pletniov ( Site 1813)

location_facility: Fondazione Policlinico Universitario A. Gemelli ( Site 1512)

location_facility: University College London Hospitals NHS Foundation Trust ( Site 1320)

location_facility: Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1114)

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 2607)

location_facility: Medizinische Universitaet Wien ( Site 0903)

location_facility: Konya Necmettin Erbakan University Medical Faculty ( Site 2104)

location_facility: CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0106)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 2305)

location_facility: Istituto Clinico Humanitas Research Hospital ( Site 1500)

location_facility: Herlev og Gentofte Hospital. ( Site 1004)

location_facility: Chang Gung Medical Foundation. Linkou ( Site 0502)

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1716)

location_facility: CHUV (centre hospitalier universitaire vaudois) ( Site 2002)

location_facility: Staedtisches Klinikum Braunschweig gGmbH ( Site 1217)

location_facility: National Cheng Kung University Hospital ( Site 0503)

location_facility: Ankara Universitesi Tip Fakultesi. ( Site 2101)

location_facility: Twoja Przychodnia - Szczeciskie Centrum Medyczne ( Site 1721)

location_facility: Tampereen yliopistollinen sairaala ( Site 1022)

location_facility: Assaf Harofeh Medical Center ( Site 1405)

location_facility: C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 1117)

location_facility: Yokohama City University Medical Center ( Site 0735)

location_facility: Royal Cornwall Hospitals NHS Trust ( Site 1317)

location_facility: Clinica Universidad Catolica del Maule ( Site 2407)

location_facility: Sapporo Medical University Hospital ( Site 0730)

location_facility: Radboud University Medical Center ( Site 1606)

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 1503)

location_facility: Dokkyo Medical University Saitama Medical Center ( Site 0736)

location_facility: Hospital San Lucas Cardiologica del Sureste ( Site 2606)

location_facility: Chonnam National University Hwasun Hospital ( Site 0406)

location_facility: Istanbul Uni. Cerrahpasa Tip Fakultesi ( Site 2100)

location_facility: Administradora Country SA - Clinica del Country ( Site 2507)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1508)

location_facility: Charite Universitaetsmedizin Berlin ( Site 1201)

location_facility: Peter MacCallum Cancer Centre ( Site 0306)

location_facility: Yamaguchi University Hospital ( Site 0746)

location_facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1700)

location_facility: Boca Raton Clinical Research QTO ( Site 2611)

location_facility: Cotton-O'Neil Cancer Center ( Site 0228)

location_facility: Tallaght University Hospital ( Site 1301)

location_facility: UCLA Hematology/Oncology - Santa Monica ( Site 0241)

location_facility: TYKS T-sairaala Syopatautien pkl ( Site 1019)

location_facility: Nara Medical University Hospital ( Site 0744)

location_facility: University of Colorado, Anschutz Cancer Pavilion ( Site 0236)

location_facility: Port Macquarie Base Hospital ( Site 0301)

location_facility: Antoni van Leeuwenhoek Ziekenhuis ( Site 1603)

location_facility: University Hospital Limerick ( Site 1305)

location_facility: Hospital Militar Central [Lima, Peru] ( Site 2704)

location_facility: Peking University First Hospital ( Site 0800)

summary: This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus ADT versus placebo plus enzalutamide plus ADT in participants with mHSPC. The primary hypothesis is that in participants with mHSPC, the combination of pembrolizumab plus enzalutamide plus ADT is superior to placebo plus enzalutamide plus ADT with respect to 1) radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) and 2) overall survival (OS).


title: A Prospective, Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Transcatheter Aortic Valve Implantation in Female Patients Who Have Severe Symptomatic Aortic Stenosis Requiring Aortic Valve Replacement

acronym: RHEIA

summary: Purpose of this prospective, randomized, controlled, multi-center study is to evaluate the safety and efficacy of Transcatheter Aortic Valve Implantation (TAVI) as compared to surgical aortic valve replacement (SAVR) in female patients with severe symptomatic aortic stenosis. Patients will be randomized 1:1 to receive either TAVI or SAVR aortic valve replacement. For TAVI procedure, Edwards SAPIEN 3 THV system Model 9600 TFX (20, 23, 26 and 29 mm) or SAPIEN 3 Ultra THV system Model 9750 TFX (20, 23, 26) with the associated transfemoral delivery systems will be sued, for SAVR any commercially available surgical bioprosthetic valve. Patients will undergo the following visits: Screening, Procedure, Post Procedure, Discharge, 30 day, 6 months (telephone contact) and 1 year.

primary_purpose: Other

ReferenceCitation: Eltchaninoff H, Bonaros N, Prendergast B, Nietlispach F, Vasa-Nicotera M, Chieffo A, Pibarot P, Bramlage P, Sykorova L, Kurucova J, Bax JJ, Windecker S, Dumonteil N, Tchetche D. Rationale and design of a prospective, randomized, controlled, multicenter study to evaluate the safety and efficacy of transcatheter heart valve replacement in female patients with severe symptomatic aortic stenosis requiring aortic valve intervention (Randomized researcH in womEn all comers wIth Aortic stenosis [RHEIA] trial). Am Heart J. 2020 Oct;228:27-35. doi: 10.1016/j.ahj.2020.06.016. Epub 2020 Jun 30.

lead_sponsor: SSS International Clinical Research GmbH

location_country:
Poland
United Kingdom
Greece
Austria
Ireland
Italy
Finland
Netherlands
Switzerland
Sweden
France
Belgium
Germany
Cyprus
Czechia

location_facility: CHU de Bordeaux - Hôpital cardiologique du Haut-Lévêqu

location_facility: Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco"

location_facility: CHU de Nantes - Hôpital Guillaume et René Laënnec

location_facility: Universitätsklinikum St. Pölten - Lilienfeld

location_facility: Universitätsklinik der Ruhr-Universität Bochum

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Górnośląskie Centrum Medyczne SUM Katowice

location_facility: CHU Clermont-Ferrand - Hôpital Gabriel Montpied

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

location_facility: Oxford University Hospitals - John Radcliffe hospital

location_facility: Universitäres Herz- und Gefäßzentrum UKE Hamburg GmbH

location_facility: IKEM (Institut Klinické a Experimentální Medicíny)

intervention_type: Procedure


title: A Phase IIIb Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis

acronym: O'HAND

summary: This study will evaluate the efficacy and safety of ocrelizumab ( Ocrevus®) compared with placebo in participants with primary progressive multiple sclerosis (PPMS), including participants later in their disease course. This study focuses on upper limit disability progression. This study will consist of the following phases: screening, double-blind treatment, follow-up 1 (FU1), an optional open-label extension (OLE), follow-up 2 (FU2), and B-cell monitoring (BCM).

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Romania
Belgium
Poland
Portugal
Austria
Australia
Russian Federation
Mexico
Egypt
Canada
Hungary
Germany
Bulgaria
Ireland
Georgia
New Zealand
France
Colombia

location_facility: Walton Centre For Neurology and Neurosurgery

location_facility: AOU dell'Università degli Studi della Campania Luigi Vanvitelli

location_facility: MS and Neuromuscular Center of Excellence

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga

location_facility: Clinica Colsanitas S.A. sede Clinica Universitaria Colombia

location_facility: Queen Elizabeth University Hospital - PPDS

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Centro Hospitalar do Porto - Hospital de Santo António

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Centro de Diagnostico Neurofisiologico S.C

location_facility: ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS

location_facility: Hopital Pierre Wertheimer - Hopital Neurologique

location_facility: City Clinical Hospital #15 n.a. N.F. Filatov

location_facility: Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: Miedzyleski Szpital Specjalistyczny w Warszawie

location_facility: Centre Hospitalier de Colmar - Hopital Louis Pasteur; Service de Neurologie

location_facility: Spitalul Municipal Dr.Alexandru Simionescu Hunedoara

location_facility: State University of New York at Buffalo; Department of Neurology

location_facility: Dalhousie Multiple Sclerosis Research Unit

location_facility: Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

location_facility: Multiprofile Hospital For Active Treatment Avis Medica

location_facility: Complejo Hospitalario Universitario de Vigo

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

location_facility: Wellington Hospital; Department of Neurology

location_facility: CHU de Nimes - Hopital Universitaire Caremeau

location_facility: Azienda Ospedaliera di Padova; Clinica Neurologica

location_facility: FSBIH Siberian Regional Medical Centre of FMBA of Russia

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh

location_facility: Hospital Universitario HM Sanchinarro-CIOCC

location_facility: Maxine Mesinger MS Clinic/Baylor College of Medicine; Neurology

location_facility: Clinical Research Center Sp. z o.o. MEDIC-R Spółka Komandytowa

location_facility: Municipal Institution Vinnytsia Regional Psychoneurological Hospital n.a. O.I. Yushchenko

location_facility: ASST degli Spedali Civili di Brescia - Presidio Ospedaliero di Montichiari

location_facility: Siberian State Medical University of Roszdrav

location_facility: COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddział Neurologiczny

location_facility: Complejo Asistencial Universitario de Salamanca - H. Clinico

location_facility: Sociedad de Cirugia de Bogota Hospital San Jose

location_facility: Medical Center of LLC Medical Clinic Blagomed

location_facility: Zaporizhia City Multispecialty Clinical Hospital #9

location_facility: Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital

location_facility: Hopital Saint Vincent de Paul - GHICL Lille - Parent

location_facility: City Center of MS Treatment based on Saint-Petersburg City Clinical Hospital #31

location_facility: Hospital Universitario Virgen de La Arrixaca

location_facility: The National Hospital for Neurology & Neurosurgery

location_facility: Peninsula College of Medicine and Dentistry

location_facility: Unidad de Investigacion en Salud de Chihuahua

location_facility: City Out Patient Clinic For Rehabilitation Treatment #7

location_facility: Medical Clinical Research Center of Medical Center LLC Health Clinic

location_facility: Alexandria University Hospital; New University Hospitlal Building;Clinical Research Center CRC

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: SPSK Nr 1 Im Prof S Szyszko Slaskiego Uniwersytetu Medcznego

location_facility: Republican Clinical Hospital For Rehabilitation Treatment

location_facility: Centre Hospitalier Universitaire de Clermont Ferrand

location_facility: LLC Medical Center Family Medicine Clinic

location_facility: Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital

location_facility: Hospital Regional Universitario de Malaga - Hospital General

location_facility: Medical Centre of PE First Private Clinic

location_facility: M.A. - LEK A. M. Maciejowscy SC. Centrum Terapii SM

location_facility: Sayed Galal University Hospital; Neurology Department

location_facility: Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD

location_facility: Targu Mures Clinical Emergency County Hospital

location_facility: Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital

location_facility: ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council

location_facility: City Hospital #40 of Kurortniy Administrative District

location_facility: Clinical Associates in Research Therapeutics of Americas-Mexico CARTA-MEX

location_facility: Regional State Budget Institution of Healthcare Tver Regional Clinical Hospital

location_facility: State Healthcare Institution Territorial Clinical Hospital

location_facility: SBHI of Nizhny Novgorod region City Clinical Hospital #3; neurology department

location_facility: SP ZOZ Szpital Uniwersytecki w Krakowie; Oddzial Kliniczny Kliniki Neurologii

location_facility: Samara Regional Clinical Hospital named after V.D. Seredavina

location_facility: Rejdak Konrad Indywidualna Praktyka Lekarska dr hab. Konrad Rejdak

location_facility: Nizhegorodskaya Regional Clinical Hospital n.a. Semashko

location_facility: Moscow Regional Research Clinical Institute Na Mfvladimirskiy


title: Personalized Therapy Study - Attain Stability Quad Post-Approval Study

acronym: ASQ

summary: The purpose of this Post-Approval Study (PAS) is to evaluate the long-term performance of the Model 4798 Left Ventricular (LV) lead in a real-world patient population. Patients will be followed for the duration of the PAS. This study is required by FDA as a condition of approval of the Model 4798 LV lead and is integrated within the Product Surveillance Registry (PSR).

study_type: Observational

time_perspective: Prospective

lead_sponsor: Medtronic

location_country:
Portugal
Spain
Italy
Greece
United Kingdom
Switzerland
United States
France

location_facility: Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"

location_facility: New York-Presbyterian Hospital/Weill Cornell Medical Center

location_facility: Centro Hospitalar Universitário de São João

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela

location_facility: Cardiovascular Consultants Medical Group (Van Nuys)

location_facility: UPMC Heart and Vascular Institute at UPMC Hamot

location_facility: Hospital da Senhora da Oliveira - Guimarães

location_facility: The James Cook University Hospital - South Tees Hospitals NHS

location_facility: University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

location_facility: Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists

location_facility: Sheffield Vascular Institute, Sheffield Teaching Hospitals NHS - Northern General

location_facility: Centre Hospitalier Universitaire Saint Étienne - Hôpital Nord

location_facility: Imperial College Healthcare NHS Trust - Hammersmith Hospital

location_facility: Générale de Santé - Hôpital Privé Saint Martin

location_facility: CHRU Brest - Hôpital de la Cavale Blanche

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Liverpool Heart and Chest Hospital NHS Foundation Trust

location_facility: Cardiovascular Institute of Northwest Florida

location_facility: Central Manchester University Hospitals NHS - Manchester Royal Infirmary

location_facility: Hospital Universitario Nuestra Señora de Candelaria

location_facility: Azienda ospedaleria Santa Maria della Misericordia di Udine

location_facility: Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE

location_facility: Presidio Ospedaliero Centrale - SS. Annunziata

location_facility: Hospital Universitario Clínico San Cecilio

location_facility: Texas Cardiac Arrhythmia Research Foundation

location_facility: Blackpool, Fylde and Wyre Hospitals NHS Foundation Trust - Blackpool Victoria Hospital

location_facility: Cardiology Associates of Northeast Arkansas

location_facility: CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol

location_facility: Azienda Ospedaliera Ospedale Niguarda Ca Granda

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: North Memorial Heart and Vascular Institute

location_facility: New York-Presbyterian Hospital/Columbia University Medical Center

intervention_type: Device


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 Established Cardiovascular Disease

acronym: Lp(a)HORIZON

summary: This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)

ReferenceCitation: Tsimikas S, Reeves RR, Patel MP. Always Present, But Now Rediscovered: Lp(a) as a Predictor of Long-Term Outcomes in PCI. JACC Cardiovasc Interv. 2021 Sep 27;14(18):2069-2072. doi: 10.1016/j.jcin.2021.08.032.

ReferenceCitation: Plakogiannis R, Sorbera M, Fischetti B, Chen M. The Role of Antisense Therapies Targeting Lipoprotein(a). J Cardiovasc Pharmacol. 2021 Jul 1;78(1):e5-e11. doi: 10.1097/FJC.0000000000001045. Review.

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient -level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with the applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Italy
United Kingdom
United States
Peru
Belgium
Iceland
Japan
Romania
South Africa
Czechia
Poland
Hong Kong
Portugal
Slovenia
Austria
Australia
Russian Federation
Argentina
Puerto Rico
India
Israel
Turkey
Mexico
Norway
Sweden
Slovakia
Brazil
Canada
Switzerland
Guatemala
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Greece
Korea, Republic of
France
Chile
Colombia
Netherlands


title: A Phase 3 Randomized, Open-Label, Multicenter Study Comparing Zanubrutinib (BGB-3111) Plus Rituximab Versus Bendamustine Plus Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation

lead_sponsor: BeiGene

ReferenceCitation: Dreyling M, Tam CS, Wang M, Smith SD, Ladetto M, Huang H, Novotny W, Co M, Romano A, Holmgren E, Huang J, Gouill SL. A Phase III study of zanubrutinib plus rituximab versus bendamustine plus rituximab in transplant-ineligible, untreated mantle cell lymphoma. Future Oncol. 2021 Jan;17(3):255-262. doi: 10.2217/fon-2020-0794. Epub 2020 Sep 28.

location_country:
Poland
Taiwan
Romania
Spain
Ireland
Austria
Australia
Italy
Canada
Lithuania
New Zealand
Ukraine
United Kingdom
United States
France
China
Belgium
Japan
Germany

location_facility: Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli

location_facility: Pratia Małopolskie Centrum Medyczne (MCM) Kraków

location_facility: University Hospital, Kyoto Prefectural Univ of Medicine

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

location_facility: Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez

location_facility: Hospital Regional Universitario de Málaga - Hospital General

location_facility: Specjalistyczny Szpital im. dr Alfreda Sokolowskiego

location_facility: Azienda Ospedaliero Universitaria Maggiore della Carità di Novara

location_facility: Centre Hospitalier Intercommunal de Cornouaille - Hôpital Laënnec

location_facility: Wojewodzki Szpital Specjalistyczny w Legnicy

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: Szpital Uniwersytecki Nr. 2 im Dr. Jana Biziela w Bydgoszczy

location_facility: MUW - AKH - Universitaetsklinik fuer Innere Medizin II

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Centro Ricerche Cliniche di Verona (CRC)

location_facility: East Carolina University - Brody School of Medicine

location_facility: Sc Ematologia, Azienda Unita' Sanitaria Locale Irccs

location_facility: Tri-Service General Hospital - Neihu Branch - Hematology

location_facility: Hospital Universitari de Girona Dr Josep Trueta

location_facility: SALK- US- Universitatsklinik fuer Innere Medizin II, Kardiologie und internistische Intensivmedizin

location_facility: Silesian Healthy Blood Clinic Grosicki, Grosicka Sp. j.

location_facility: Harbor-UCLA Medical Center- The Liu Center for the Study and Treatment of Pulmonary Hypertension

location_facility: Joe Arrington Cancer Research and Treatment Center (JACC)

location_facility: Rush University Medical Center - Rush University Gastroenterologists

location_facility: Uniwersytet Medyczny im. Piastów Śląskich we Wrocławiu

location_facility: University Hospital Limerick - Mid Western Cancer Centre

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Institut Catalia d'oncologia- l'Hospitalet

location_facility: Copernicus Podmiot Leczniczy Wojewódzkiego Centrum Onkologii

location_facility: Uniwersytet Medyczny w Lodzi - Klinika Hematologii

location_facility: Centre Hospitalier Universitaire (CHU) de Liege - Site du Sart Tilman

location_facility: Centre Hospitalier Universitaire Universite Catholique de Louvain Site Godinne

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Centre Hospitalier Universitaire Nantes - Hotel Dieu

summary: This is a randomized study to compare the efficacy and safety of zanubrutinib plus rituximab versus bendamustine plus rituximab in previously untreated participants with mantle cell lymphoma (MCL) who are not eligible for stem cell transplantation.


title: A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Moderate-to-Severe Atopic Dermatitis

summary: Long-Term Safety and Efficacy of Nemolizumab in Subjects with Moderate-to-Severe Atopic Dermatitis Description

status: Enrolling by invitation

lead_sponsor: Galderma R&D

location_country:
Spain
Italy
United Kingdom
Lithuania
United States
Belgium
Czechia
Poland
Austria
Australia
Singapore
Canada
Hungary
Germany
Bulgaria
Latvia
Georgia
Estonia
New Zealand
Korea, Republic of
France
Netherlands

location_facility:
Galderma Investigational Site 8828
Galderma Investigational Site 8807
Galderma Investigational Site 8620
Galderma Investigational Site 8329
Galderma Investigational Site 6024
Galderma Investigational Site 6245
Galderma Investigational Site 8795
Galderma Investigational Site 5469
Galderma Investigational Site 8224
Galderma Investigational Site 8802
Galderma Investigational Site 6136
Galderma Investigational Site 6058
Galderma Investigational Site 6052
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Galderma Investigational Site 8142
Galderma Investigational Site 5137
Galderma Investigational Site 6231
Galderma Investigational Site 8206
Galderma Investigational Site 8816
Galderma Investigational Site 8805
Galderma Investigational Site 8870
Galderma Investigational Site 8618
Galderma Investigational Site 6095
Galderma Investigational Site 6163
Galderma Investigational Site 6083
Galderma Investigational Site 8721
Galderma Investigational Site 8880
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Galderma Investigational Site 6036
Galderma Investigational Site 8862
Galderma Investigational Site 6254
Galderma Investigational Site 6168
Galderma Investigational Site 5707
Galderma Investigational Site 6038
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Galderma Investigational Site 8718
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Galderma Investigational Site 8674
Galderma Investigational Site 8617
Galderma Investigational Site 8722
Galderma Investigational Site 8772
Galderma Investigational Site 6039
Galderma Investigational Site 6150
Galderma Investigational Site 8242
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Galderma Investigational Site 8719
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Galderma Investigational Site 8810
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Galderma Investigational Site 6222
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Galderma Investigational Site 8777
Galderma Investigational Site 6085
Galderma Investigational Site 6071
Galderma Investigational Site 8238
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Galderma Investigational Site 6235
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Galderma Investigational Site 5368
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Galderma Investigational Site 6157
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Galderma Investigational Site 8739
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Galderma Investigational Site 5513
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Galderma Investigational Site 6223
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Galderma Investigational Site 6237
Galderma Investigational Site 8109
Galderma Investigational Site 6063
Galderma Investigational Site 8670
Galderma Investigational Site 6051
Galderma Investigational Site 8905
Galderma Investigational Site 6105
Galderma Investigational Site 8817
Galderma Investigational Site 6088
Galderma Investigational Site 6146
Galderma Investigational Site 6057
Galderma Investigational Site 6021
Galderma Investigational Site 5407
Galderma Investigational Site 5570
Galderma Investigational Site 6056
Galderma Investigational Site 6082
Galderma Investigational Site 5382
Galderma Investigational Site 8831
Galderma Investigational Site 8336
Galderma Investigational Site 6055
Galderma Investigational Site 8804
Galderma Investigational Site 5363
Galderma Investigational Site 6037
Galderma Investigational Site 8000
Galderma Investigational Site 6167
Galderma Investigational Site 6155
Galderma Investigational Site 6035
Galderma Investigational Site 6086
Galderma Investigational Site 6244
Galderma Investigational Site 6203
Galderma Investigational Site 9916
Galderma Investigational Site 6053
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Galderma Investigational Site 6194
Galderma Investigational Site 6238
Galderma Investigational Site 8749
Galderma Investigational Site 8664
Galderma Investigational Site 6119
Galderma Investigational Site 6099
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Galderma Investigational Site 8737
Galderma Investigational Site 5638
Galderma Investigational Site 8692
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Galderma Investigational Site 8780
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Galderma Investigational Site 6073
Galderma Investigational Site 6022
Galderma Investigational Site 8712
Galderma Investigational Site 8506
Galderma Investigational Site 6198
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Galderma Investigational Site 8212
Galderma Investigational Site 6046
Galderma Investigational Site 8125
Galderma Investigational Site 6165
Galderma Investigational Site 6131
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Galderma Investigational Site 8744
Galderma Investigational Site 6101
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Galderma Investigational Site 6214
Galderma Investigational Site 6216
Galderma Investigational Site 9934
Galderma Investigational Site 8901
Galderma Investigational Site 8713
Galderma Investigational Site 6251
Galderma Investigational Site 8671
Galderma Investigational Site 6132
Galderma Investigational Site 6078
Galderma Investigational Site 6090
Galderma Investigational Site 8702
Galderma Investigational Site 8728
Galderma Investigational Site 6041
Galderma Investigational Site 8003
Galderma Investigational Site 6250
Galderma Investigational Site 8586
Galderma Investigational Site 6197
Galderma Investigational Site 5918
Galderma Investigational Site 6236
Galderma Investigational Site 6121
Galderma Investigational Site 6156
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Galderma Investigational Site 8813
Galderma Investigational Site 6077
Galderma Investigational Site 8161
Galderma Investigational Site 8747
Galderma Investigational Site 6154
Galderma Investigational Site 8904
Galderma Investigational Site 8833
Galderma Investigational Site 6116
Galderma Investigational Site 6106
Galderma Investigational Site 6111
Galderma Investigational Site 5566
Galderma Investigational Site 6108
Galderma Investigational Site 8839
Galderma Investigational Site 6208
Galderma Investigational Site 8447
Galderma Investigational Site 5453
Galderma Investigational Site 8711
Galderma Investigational Site 8610
Galderma Investigational Site 6110
Galderma Investigational Site 6126
Galderma Investigational Site 6138
Galderma Investigational Site 6212
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Galderma Investigational Site 5021
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Galderma Investigational Site 6093
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Galderma Investigational Site 8771
Galderma Investigational Site 6129
Galderma Investigational Site 6161
Galderma Investigational Site 6097
Galderma Investigational Site 5551
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Galderma Investigational Site 8637
Galderma Investigational Site 8801
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Galderma Investigational Site 8726
Galderma Investigational Site 6049
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Galderma Investigational Site 8686
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Galderma Investigational Site 6027
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Galderma Investigational Site 8636
Galderma Investigational Site 5842
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Galderma Investigational Site 6147
Galderma Investigational Site 8903
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Galderma Investigational Site 6033
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Galderma Investigational Site 8126
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Galderma Investigational Site 6075
Galderma Investigational Site 6025
Galderma Investigational Site 6228
Galderma Investigational Site 6112
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Galderma Investigational Site 6102
Galderma Investigational Site 6094
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Galderma Investigational Site 6045
Galderma Investigational Site 6104
Galderma Investigational Site 6069
Galderma Investigational Site 5482
Galderma Investigational Site 8521
Galderma Investigational Site 8608
Galderma Investigational Site 6124
Galderma Investigational Site 6190
Galderma Investigational Site 6061
Galderma Investigational Site 6186
Galderma Investigational Site 8155
Galderma Investigational Site 8748
Galderma Investigational Site 8826
Galderma Investigational Site 8391
Galderma Investigational Site 8806
Galderma Investigational Site 8658
Galderma Investigational Site 5367
Galderma Investigational Site 5567
Galderma Investigational Site 8799
Galderma Investigational Site 6133
Galderma Investigational Site 6080
Galderma Investigational Site 8731
Galderma Investigational Site 6166
Galderma Investigational Site 8888
Galderma Investigational Site 6240
Galderma Investigational Site 6084
Galderma Investigational Site 8893
Galderma Investigational Site 8656

status_simplified: Unknown


title: A Randomized, Double-Blind, Controlled Phase 3 Study of Cabozantinib in Combination With Nivolumab and Ipilimumab Versus Nivolumab and Ipilimumab in Subjects With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma of Intermediate or Poor Risk

summary: This is a multicenter, randomized, double-blinded, controlled Phase 3 trial of cabozantinib in combination with nivolumab and ipilimumab versus nivolumab and ipilimumab in combination with matched placebo. Approximately 840 eligible subjects with intermediate- or poor-risk advanced or metastatic RCC by IMDC criteria will be randomized in a 1:1 ratio at approximately 180 sites.

ReferenceCitation: Labriola MK, George DJ. Setting a new standard for long-term survival in metastatic kidney cancer. Cancer. 2022 Jun 1;128(11):2058-2060. doi: 10.1002/cncr.34177. Epub 2022 Apr 5.

ReferenceCitation: Mar N, Kaakour D, Rezazadeh Kalebasty A. Renal Cell Carcinoma-Lessons in Diversity, Breakthroughs, and Challenges. JCO Oncol Pract. 2022 Mar;18(3):197-199. doi: 10.1200/OP.21.00446. Epub 2021 Sep 22.

ReferenceCitation: Hofmann F, Hwang EC, Lam TB, Bex A, Yuan Y, Marconi LS, Ljungberg B. Targeted therapy for metastatic renal cell carcinoma. Cochrane Database Syst Rev. 2020 Oct 14;10:CD012796. doi: 10.1002/14651858.CD012796.pub2.

lead_sponsor: Exelixis

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Czechia
Poland
Hong Kong
Austria
Australia
Argentina
Israel
Mexico
Singapore
Brazil
Canada
Hungary
Germany
Taiwan
New Zealand
Finland
Korea, Republic of
France
Chile
Netherlands

location_facility:
Exelixis Clinical Site #29
Exelixis Clinical Site #31
Exelixis Clinical Site #7C
Exelixis Clinical Site #13
Exelixis Clinical Site #160
Exelixis Clinical Site #85
Exelixis Clinical Site #136
Exelixis Clinical Site #4
Exelixis Clinical Site #1
Exelixis Clinical Site #112
Exelixis Clinical Site #60
Exelixis Clinical Site #127
Exelixis Clinical Site #91
Exelixis Clinical Site #99
Exelixis Clinical Site #135
Exelixis Clinical Site #18
Exelixis Clinical Site #73
Exelixis Clinical Site #132
Exelixis Clinical Site #32
Exelixis Clinical Site #74
Exelixis Clinical Site #37
Exelixis Clinical Site #137
Exelixis Clinical Site #134
Exelixis Clinical Site #120
Exelixis Clinical Site #53
Exelixis Clinical Site #10
Exelixis Clinical Site #105
Exelixis Clinical Site #88
Exelixis Clinical Site #126
Exelixis Clinical Site #42
Exelixis Clinical Site #25
Exelixis Clinical Site #161
Exelixis Clinical Site #69
Exelixis Clinical Site #166
Exelixis Clinical Site #47
Exelixis Clinical Site #92
Exelixis Clinical Site #9
Exelixis Clinical Site #116
Exelixis Clinical Site #154
Exelixis Clinical Site #131
Exelixis Clinical Site #52
Exelixis Clinical Site #61
Exelixis Clinical Site #95
Exelixis Clinical Site #39
Exelixis Clinical Site #128
Exelixis Clinical Site #5
Exelixis Clinical Site #111
Exelixis Clinical Site #72
Exelixis Clinical Site #7A
Exelixis Clinical Site #20
Exelixis Clinical Site #138
Exelixis Clinical Site #163
Exelixis Clinical Site #94
Exelixis Clinical Site #58B
Exelixis Clinical Site #41
Exelixis Clinical Site #55
Exelixis Clinical Site #27
Exelixis Clinical Site #158
Exelixis Clinical Site #107
Exelixis Clinical Site #58A
Exelixis Clinical Site #19
Exelixis Clinical Site #96
Exelixis Clinical Site #64
Exelixis Clinical Site #117
Exelixis Clinical Site #139
Exelixis Clinical Site #167
Exelixis Clinical Site #153
Exelixis Clinical Site #119
Exelixis Clinical Site #104
Exelixis Clinical Site #142
Exelixis Clinical Site #45
Exelixis Clinical Site #90
Exelixis Clinical Site #81
Exelixis Clinical Site #115
Exelixis Clinical Site #59
Exelixis Clinical Site #35
Exelixis Clinical Site #40
Exelixis Clinical Site #143
Exelixis Clinical Site #113
Exelixis Clinical Site #38
Exelixis Clinical Site #28
Exelixis Clinical Site #150
Exelixis Clinical Site #26
Exelixis Clinical Site #22
Exelixis Clinical Site #54
Exelixis Clinical Site #57
Exelixis Clinical Site #118
Exelixis Clinical Site #84
Exelixis Clinical Site #65
Exelixis Clinical Site #172
Exelixis Clinical Site #98
Exelixis Clinical Site #144
Exelixis Clinical Site #12
Exelixis Clinical Site #46
Exelixis Clinical Site #114
Exelixis Clinical Site #34
Exelixis Clinical Site #162
Exelixis Clinical Site #44
Exelixis Clinical Site #121
Exelixis Clinical Site #151
Exelixis Clinical Site #159
Exelixis Clinical Site #141
Exelixis Clinical Site #124
Exelixis Clinical Site #30
Exelixis Clinical Site #68
Exelixis Clinical Site #7B
Exelixis Clinical Site #43
Exelixis Clinical Site #77
Exelixis Clinical Site #86
Exelixis Clinical Site #15
Exelixis Clinical Site #173
Exelixis Clinical Site #102
Exelixis Clinical Site #24
Exelixis Clinical Site #2
Exelixis Clinical Site #168
Exelixis Clinical Site #67
Exelixis Clinical Site #164
Exelixis Clinical Site #80
Exelixis Clinical Site #50
Exelixis Clinical Site #122
Exelixis Clinical Site #6
Exelixis Clinical Site #3
Exelixis Clinical Site #63
Exelixis Clinical Site #140
Exelixis Clincal Site #129
Exelixis Clinical Site #17
Exelixis Clinical Site #100
Exelixis Clinical Site #70
Exelixis Clinical Site #155
Exelixis Clinical Site #71
Exelixis Clinical Site #49
Exelixis Clinical Site #66
Exelixis Clinical Site #89
Exelixis Clinical Site #23
Exelixis Clinical Site #146
Exelixis Clinical Site #110
Exelixis Clinical Site #62
Exelixis Clinical Site #8
Exelixis Clinical Site #14
Exelixis Clinical Site #11
Exelixis Clinical Site #125
Exelixis Clinical Site #36
Exelixis Clinical Site #171
Exelixis Clinical Site #83
Exelixis Clinical Site #56
Exelixis Clinical Site #109
Exelixis Clinical Site #78
Exelixis Clinical Site #97
Exelixis Clinical Site #152
Exelixis Clinical Site #51
Exelixis Clinical Site #123
Exelixis Clinical Site #169
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Exelixis Clinical Site #148
Exelixis Clinical Site #93
Exelixis Clinical Site #75
Exelixis Clinical Site #147
Exelixis Clinical Site #33
Exelixis Clinical Site #101
Exelixis Clinical Site #76


acronym: PRIMIS

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Subjects With Primary Sclerosing Cholangitis

location_country:
Denmark
Spain
Italy
Austria
Australia
New Zealand
Canada
Finland
Switzerland
United Kingdom
United States
France
Israel
Belgium
Japan
Germany

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Ca'Granda Ospedale Maggiore Policlinico UOC Gastroenterologia ed Epatologia

location_facility: University Hospital Birmingham NHS Foundation Trust

location_facility: Hospital Clinico Universitario Santiago de Compostela

location_facility: Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Turku University Hospital, Gastroenterology Outpatient Clinic

location_facility: Walter Reed National Military Medical Center

location_facility: University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre (WMC)

location_facility: Copenhagen University Hospital - Hvidovre

location_facility: Vanderbilt University Medical Center - Digestive Disease Center

location_facility: IRCCS Ospedale Sollievo della Sofferenza

location_facility: Baylor Scott & White Medical Center at Fort Worth

location_facility: Universitätsmedizin Mannheim, II. Medizinische Klinik

location_facility: Aintree University Hospitals NHS Foundation Trust

location_facility: Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM)

location_facility: Hospital General Universitario de Valencia

location_facility: Sutter Pacific Medical Foundation - California Pacific Medical Center

location_facility: Dipartimento Gastroenterologico e dei Trapianti

location_facility: Intermountain Medical Center - Transplant Services

location_facility: Istituto Clinico Humanitas - Unita Operativa di Epatologia

location_facility: Annette & Harold C. Simmons Transplant Institute @ Baylor University Medical Center at Dallas

location_facility: Baylor College of Medicine - Advanced Liver Therapies

location_facility: Northwell Health Center for Liver Diseases and Transplantation

location_facility: The University of NC at Chapel Hill, Clinical and Translational Research Center (CTRC)

location_facility: National University Corporation Tohoku University Tohoku University Hospital

location_facility: University of Chicago Medical Center (outpatient clinic)

location_facility: CHU de Strasbourg - Nouvel Hôpital Civil

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Azienda Ospedaliero Universitaria di Moderna, Ospedale di Baggiovara

location_facility: Chronic Viral Illness Service/McGill University Health Centre (MUHC)

location_facility: William Osler Health System - Brampton Civic Hospital

location_facility: Carolinas Medical Center - Center for Liver Disease

location_facility: Gordon and Leslie Diamond Health Care Centre, Vancouver General Hospital, UBC Division of Gastroenterology

location_facility: Michigan Medicine - University of Michigan

location_facility: Center for Liver Disease and Transplantation, Columbia University Medical Center

location_facility: Helsinki University Hospital, Endoscopy Unit, Gastroenterology Outpatient clinic, Meilahden tomisairaala

location_facility: Altman Clinical and Translational Research Institute (Clinic)

location_facility: Hospital General Universitario de Alicante

location_facility: Azienda Ospedaliero-Universitaria Pisana - Unità Operativa Epatologia

location_facility: Chelsea and Westminster Hospital NHS Foundation Trust

location_facility: University of Calgary Liver Unit - Heritage Medical Research Clinic (HMRC)

location_facility: Azienda Ospedaliera Universitaria Policlinico P. Giaccone

location_facility: Penn State Health Milton S. Hershey Medical Center

location_facility: Northwestern Memorial Hospital; Clinical Research Unit

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: Landeskrankenanstalten-Betriebsgesellscaft - KABEG, Klinikum Klagenfurt am Wörthersee

location_facility: University of Colorado Denver and Hospital

location_facility: Southern Therapy and Advanced Research LLC

location_facility: The Liver Institute at Methodist Dallas Medical Center

location_facility: The University of Vermont Medical Center

location_facility: Icahn School of Medicine at Mount Sinai Beth Israel

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez

location_facility: Schiff Center for Liver Diseases/University of Miami

location_facility: Hospital Universitari Politecnic La Fe de Valencia

location_facility: University of California, San Francisco Liver Clinic

location_facility: Coral Sea Clinical Research Institute - Mackay

location_facility: Universitätsklinikum des Saarlandes, Klinik für Innere Medizin II, Gastroenterologie und Hepatologie

location_facility: University of California, Davis Medical Center (study visits)

location_facility: Nottingham University Hospitals NHS Trust

location_facility: San Antonio Military Medical Center, Gastro/Hepatology

location_facility: Centre Hospitalier Universitaire de Liège Site Sart Tilman

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

location_facility: Saint Louis University, Gastroenterology & Hepatology

location_facility: Rutgers New Jersey Medical School - Doctors Office Center

location_facility: Hopital Robert Debré - Centre Hospitalier Universitaire de Reims

location_facility: University of Manitoba/Health Sciences Centre

location_facility: Toronto General Hospital - Toronto Centre for Liver Disease (TCLD)

location_facility: Virginia Commonwealth University Clinical Research Services Unit

summary: The primary objective of this study is to evaluate whether cilofexor reduces the risk of fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC).


acronym: Étude de non-infériorité PK portant sur le ravulizumab SC comparé au ravulizumab IV.

title: A Phase 3, Randomized, Parallel-Group, Multicenter, Open-Label, Pharmacokinetic, Noninferiority Study of Ravulizumab Administered Subcutaneously Versus Intravenously in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With Eculizumab

lead_sponsor: Alexion Pharmaceuticals

ReferenceCitation: Yenerel MN, Sicre de Fontbrune F, Piatek C, Sahin F, Füreder W, Ortiz S, Ogawa M, Ozol-Godfrey A, Sierra JR, Szer J. Phase 3 Study of Subcutaneous Versus Intravenous Ravulizumab in Eculizumab-Experienced Adult Patients with PNH: Primary Analysis and 1-Year Follow-Up. Adv Ther. 2022 Oct 22. doi: 10.1007/s12325-022-02339-3. [Epub ahead of print]

location_country:
Brazil
Spain
Italy
Austria
Australia
Russian Federation
Canada
Finland
Sweden
United States
France
Turkey
Belgium
Netherlands

summary: The primary objective of this study is to evaluate pharmacokinetics (PK) of ravulizumab administered subcutaneously via an on-body delivery system (OBDS) compared with intravenously administered ravulizumab in adult participants with PNH who are clinically stable on eculizumab for at least 6 months.


title: A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long Term Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis LUCENT 3

summary: This study is designed to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (UC).

ipd_sharing_description:
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

lead_sponsor: Eli Lilly and Company

location_country:
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Belgium
Japan
Romania
Czechia
Poland
Austria
Australia
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Malaysia
Slovakia
Canada
Switzerland
Hungary
China
Germany
Moldova, Republic of
Denmark
Taiwan
Ireland
Georgia
Latvia
Korea, Republic of
France
Netherlands

location_facility: Renji Hospital Shanghai Jiao Tong University School of Medicine

location_facility: Nizhny Novgorod Regional Hospital N.A. Semashko

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital

location_facility: Ivano-Frankivsk State Medical University

location_facility: Pusat Perubatan University Kebangsaan Malaysia

location_facility: HaFCED - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen

location_facility: M S Ramaiah Medical College and Hospitals

location_facility: Cotton-O'Neil Clinical Research Center, Digestive Health

location_facility: Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"

location_facility: Clinical Center Kragujevac Gastroenterohepatology Clinic

location_facility: National Hospital Organization Takasaki General Medical Centar

location_facility: Hospital Universitari de Girona Dr. Josep Trueta

location_facility: Gastroenterology Associates of Western Michigan, P.L.C.

location_facility: Fakultna nemocnica s poliklinikou Roosevelta Banska Bystrica

location_facility: Care Access Research LLC - Salt Lake City

location_facility: Gastroenterology Research of San Antonio

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

location_facility: Pauls Stradins Clinical Univeristy Hospital

location_facility: National Hospital Organization Kyoto Medical Center

location_facility: AKH - Gastroenterologie und Hepatologie - Interne Medizin III

location_facility: University of North Carolina Center for Inflammatory Bowel Disease

location_facility: SR Kalla Memorial Gastro & General Hospital

location_facility: Multidisciplinary Medical Clinic "Anthurium"

location_facility: SE Belgyogyaszati és Hematologiai Klinika

location_facility: Diaservis - Medical and Diagnostic Center

location_facility: Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU

location_facility: Ishida Clinic of IBD and Gastroenterology

location_facility: International Institute of Clinical Trials LLC

location_facility: Centre for Liver Research & Diagnostics, Deccan College of Medical Sciences, Owaisi Hospital & Research Centre

location_facility: GOU VPO St-Petersburg SMA n/a Mechnikov Fed. Agen of Health

location_facility: Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy

location_facility: Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho

location_facility: Centrum Medyczne Lux Med Poradnia Gastroenterologii

location_facility: Hospital Universitario Juan Ramon Jimenez

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: Gastroenterology Associates of Pensacola, PA

location_facility: Center Hospital of the National Center for Global Health and Medicine

location_facility: Communal Enterprise "Odesa Regional Clinical Hospital"

location_facility: The Catholic University of Korea, Daejeon St. Mary's Hospital

location_facility: Vinnytsia M.I. Pyrogov NMU Ch of internal medicine #1

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Kocaeli University Medical Faculty Hospital

location_facility: Research Associates of South Florida, LLC

location_facility: The Affiliated Hospital of Qingdao University

location_facility: Riga Eastern Clinical University Hospital

location_facility: Academician I.P. Pavlov First St-Petersburg State Medical University

location_facility: Clinical Applications Laboratories, Inc.

location_facility: A. Novak Transcarpathian Regional Clinical Hospital

location_facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

location_facility: Galilee Medical Center Department of Internal Medicine A

location_facility: Policlinico Gemelli - Università Cattolica del Sacro Cuore

location_facility: Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech

location_facility: Karelia Republican Hospital V.A. Baranova

location_facility: Medical Center of Limited Liability Company "Medical Center "Consilium Medical"

location_facility: Communal City Clinical Emergency Hospital, Danylo Galytskyy Lviv National Medical University

location_facility: Poona Medical Foundation. Ruby Hall Clinic

location_facility: Shanghai Jiaotong University School of Medicine Ruijin Hospital

location_facility: Vilniaus Universiteto Ligonines Santariskiu Klinikos

location_facility: Showa University Northern Yokohama Hospital

location_facility: Wojewodzki Specjalistyczny Szpital w Olsztynie

location_facility: Private Healthcare Institution Clinical Hospital Russian Railways - Medicine of Nizhniy Novgorod

location_facility: The Gordon and Leslie Diamond Health Care Centre

location_facility: National Hospital Organization Hirosaki National Hospital

location_facility: Centre hospitalier universitaire de Haut Leveque

location_facility: The Sixth Affiliated Hospital, Sun Yat-Sen University

location_facility: Gastroenterologische Praxis Balsiger, Seibold & Partner

location_facility: SHI of Yaroslavl Region Clinical Hospital #8

location_facility: Nanjing Medical University - Nanjing Jiangning Hospital

location_facility: The First People's Hospital of Yunnan Province

location_facility: The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university

location_facility: Carolina Digestive Diseases and Endoscopy Center

location_facility: Xiangya Hospital Central South University

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: Hospital Universitario Central de Asturias

location_facility: Apollo Research and Innovations, Apollo Hospitals International Ltd

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Scientific Centre of Reconstructive and Restorative Surgery

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz IV. Belgyogyaszat

location_facility: MNGI Digestive Health - Plymouth Endoscopy Center & Clinic

location_facility: Communal Non-Commercial Enterprise of Lviv Regional Council

location_facility: Centro de Investigaciones Médicas Tucuman

location_facility: University Medical Center "Bezanijska kosa"

location_facility: Regional Hospital Dr Radivoj Simonovic Sombor

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Endomedix Diagnosztikai Központ - Miskolc

location_facility: Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Intezet

location_facility: Encore Borland-Groover Clinical Research

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: University of Oklahoma Health Sciences Center

location_facility: CHU Amiens Picardie Site Sud - Service d'Hepato-gastro-entérologie

location_facility: Centro Para el Desarrollo de la Medicina y de Asistencia Medica S.C

location_facility: Azienda Ospedlaliero-Univeristaria Pisana - Ospedale di Cisanello - Gastroenterologia

location_facility: Tokyo Medical and Dental University Hospital

location_facility: The First Hospital Affiliated to AMU (Southwest Hospital)

location_facility: West China Hospital of Sichuan University

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Centre Hospitalier de Wallonie Picarde - Site Notre Dame

location_facility: Datta Meghe Institute of Medical Sciences (DU), Acharya Vinoba Bhave Rural Hospital

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas

location_facility: Gastromed Kopoń Zmudziński I Wspólnicy Spółka Jawna Specjalistyczne Centrum Gastrologii I Endoskopii

location_facility: First Affiliated Hosp of College of Med, Zhejiang University