lead_sponsor: Galecto Biotech AB

summary: This is a randomized, double-blind, placebo-controlled phase 2b trial in subjects with IPF (idiopathic pulmonary fibrosis) investigating the efficacy and safety of GB0139.

ReferenceCitation: Rebelo AL, Chevalier MT, Russo L, Pandit A. Role and therapeutic implications of protein glycosylation in neuroinflammation. Trends Mol Med. 2022 Apr;28(4):270-289. doi: 10.1016/j.molmed.2022.01.004. Epub 2022 Feb 1.

ReferenceCitation: Park AM, Khadka S, Sato F, Omura S, Fujita M, Hsu DK, Liu FT, Tsunoda I. Galectin-3 as a Therapeutic Target for NSAID-Induced Intestinal Ulcers. Front Immunol. 2020 Sep 23;11:550366. doi: 10.3389/fimmu.2020.550366. eCollection 2020.

publisher_dissemination: Frontiers

sponsor_collaborators:
Galecto Biotech AB
Syneos Health
bioRASI, LLC

location_facility: Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

location_facility: Pulmonary Institute Rabin Medical Center

location_facility: Aintree Unversity Hospital NHS Foundation Trust

location_facility: Centre Hospitalier Rgional et Universitaire - Hopital Bretonneau

location_facility: Klinikum Grossadern der Ludwig-Maximilians-Universitaet Muenchen

location_facility: University of Texas Health Sciences Center at Houston

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: CHU de la Réunion Site SUD (Terre Sainte)

location_facility: University-Hospital Policlinico Vittorio Emanuele

location_facility: National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovsky

location_facility: ZMS Zentrum für medizinische Studien GmbH

location_facility: Advanced Research for Health Improvement

location_facility: Lungenfachklinik Immenhausen Department for Clinical Studies

location_facility: Instytut Gruzlicy i Chorob Pluc, I Klinika Chorob Pluc

location_facility: University Hospital of Mondena-AOU - Policlinico di Modena

location_facility: LaPorte County Institute for Clinical Research

location_facility: Oddział Kliniczny Pulmonologii i Alergologii Szpitala Uniwersyteckiego w Krakowie

location_facility: Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

location_facility: National Research Centre for Radiation Medicine of The National Academy of Medical Sciences of UKR

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital (RHH)

location_facility: Klifeck GmbH Praxis Med. Gerald Eckhardt

location_facility: Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT)

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Clinical Research Centre - Respiratory North Bristol NHS Trust Southmead Hospital

location_facility: University of Texas Health Centre at Houston

location_facility: Centre Hospitalier Universitaire de Rennes Hopital Pontchaillou

location_facility: Jasper Summit Research, LLC Pulmonary & Sleep Associates

location_facility: AOU Città della Salute e della Scienza, PO Molinette

location_facility: Ospedale San Giuseppe Clinica Malattie dell Apparato Respiratorio

location_facility: Firestone Institute for Respiratory Health

location_facility: Studienzentrum Dr.med Falk Brunner FA fuer Innere Medizin und Pneumologie

location_facility: Hospital Universitario Central de Asturias

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Hopitaux Universitaires de Strasborg Service de Pneumologie Nouvel Hopital Civil

location_facility: Universitaetsklinikum Leipzig Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie, P

location_facility: Institute for Respiratory Health Sir Charles Gairdner Hospital

location_facility: University of Utah Health Scieces Center

location_facility: Harvard Medical School - Brigham and Womens Hospital (BWH)

location_facility: Groupe Hospitalier Hopitaux Universitaires Paris-Seine-Saint-Denis-Hopital Avicenne

location_facility: Piedmont Healthcare Pulmonary and Critical Care Research

location_facility: Dr Anees Medicine Professional Corporation

title: GALACTIC-1 -A Randomized, Double-blind, Multicentre, Parallel, Placebo-controlled Phase 2b Study in Subjects With Idiopathic Pulmonary Fibrosis (IPF) Investigating the Efficacy and Safety of GB0139, an Inhaled Galectin-3 Inhibitor Administered Via a Dry Powder Inhaler Over 52 Weeks

location_country:
Germany
Ireland
Italy
Poland
Israel
United Kingdom
Australia
Belgium
United States
Spain
Ukraine
Canada
Georgia
France

collaborators:
Syneos Health
bioRASI, LLC


type: Other Identifier

type: Registry Identifier

type: EudraCT Number

title: A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) in Participants With Treatment-naïve, Metastatic Nonsmall Cell Lung Cancer (NSCLC) Whose Tumors Have a Tumor Proportion Score (TPS) Greater Than or Equal to 1% (LEAP-007)

summary:
The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) in treatment-naïve adults with no prior systemic therapy for their metastatic non-small cell lung cancer (NSCLC) whose tumors have a programmed cell death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) greater than or equal to 1%.

The primary study hypotheses are that: 1) the combination of pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1); and 2) the combination of pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Overall Survival (OS).

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Taylor MH, Schmidt EV, Dutcus C, Pinheiro EM, Funahashi Y, Lubiniecki G, Rasco D. The LEAP program: lenvatinib plus pembrolizumab for the treatment of advanced solid tumors. Future Oncol. 2021 Feb;17(6):637-648. doi: 10.2217/fon-2020-0937. Epub 2020 Dec 10.

oa_host_type: publisher

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Future Science Ltd

ipd_sharing: Yes

lead_sponsor: Merck Sharp & Dohme LLC

sponsor_collaborators:
Merck Sharp & Dohme LLC
Eisai Inc.

location_country:
Poland
Australia
Japan
Turkey
Canada
France
Colombia
Hungary
United States
Ukraine
China
Malaysia
Estonia
Italy
Mexico
Korea, Republic of
Taiwan
Russian Federation
Israel

location_facility: The First Hospital of Jilin University ( Site 0110)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0266)

location_facility: Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 0233)

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 0321)

location_facility: National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0027)

location_facility: Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0318)

location_facility: Oregon Health Sciences University ( Site 0544)

location_facility: Taipei Veterans General Hospital ( Site 0089)

location_facility: Hospital Tengku Ampuan Afzan ( Site 0062)

location_facility: Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 0323)

location_facility: The First Affiliated Hospital of Anhui Medical University ( Site 0113)

location_facility: Oaxaca Site Management Organization SC ( Site 0389)

location_facility: SPZOZ USK nr 1 im. Norberta Barlickiego UM w Lodzi ( Site 0256)

location_facility: Ironwood Cancer & Research Centers ( Site 0541)

location_facility: Ukranian Center of TomoTherapy ( Site 0344)

location_facility: Institut Kanser Negara - National Cancer Institute ( Site 0063)

location_facility: Chungbuk National University Hospital ( Site 0079)

location_facility: Fundacion Centro de Investigacion Clinica CIC ( Site 0366)

location_facility: Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi ( Site 0314)

location_facility: Szpital Uniwersytecki im. Karola Marcinkowskiego ( Site 0247)

location_facility: 2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0114)

location_facility: Centro di Riferimento Oncologico CRO ( Site 0235)

location_facility: Juntendo University Hospital ( Site 0029)

location_facility: Tudogyogyintezet Torokbalint ( Site 0205)

location_facility: Central Texas Veterans Healthcare System ( Site 0533)

location_facility: Ospedale Santa Maria delle Croci ( Site 0232)

location_facility: Ballarat Oncology and Haematology Services ( Site 0008)

location_facility: St John of God Murdoch Medical Clinic ( Site 0001)

location_facility: Park Nicollet Frauenshuh Cancer Center ( Site 0554)

location_facility: University Malaya Medical Centre ( Site 0061)

location_facility: Okayama University Hospital ( Site 0020)

location_facility: City Clinical Oncology Center ( Site 0260)

location_facility: Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0207)

location_facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 0262)

location_facility: SBHI Samara Regional Clinical Oncology Dispensary ( Site 0265)

location_facility: Windsor Regional Cancer Program ( Site 0404)

location_facility: Xiangya Hospital of Central South University ( Site 0115)

location_facility: Azienda Ospedaliera San Giuseppe Moscati ( Site 0234)

location_facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 0381)

location_facility: Instituto Nacional de Cancerologia. ( Site 0382)

location_facility: National Cheng Kung University Hospital ( Site 0086)

location_facility: Northwest Georgia Oncology Centers PC ( Site 0518)

location_facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 0250)

location_facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0243)

location_facility: Taipei Medical University Shuang Ho Hospital ( Site 0090)

location_facility: MI Precarpathian Clinical Oncology Center ( Site 0346)

location_facility: Beijing Chest Hospital Capital Medical University ( Site 0111)

location_facility: Aichi Cancer Center Hospital ( Site 0018)

location_facility: SBHI Leningrad Regional Clinical Hospital ( Site 0263)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 0213)

location_facility: Peking Union Medical College Hospital ( Site 0105)

location_facility: National Taiwan University Hospital Hsin-Chu Branch ( Site 0087)

location_facility: Consultorios de Medicina Especializada del Sector Privado ( Site 0388)

location_facility: Samsun Medical Park Hastanesi ( Site 0320)

location_facility: Regional Centre of Oncology-Thoracic organs ( Site 0337)

location_facility: Nippon Medical School Hospital ( Site 0024)

location_facility: Wollongong Private Hospital ( Site 0005)

location_facility: Zhongshan Hospital Fudan University ( Site 0100)

location_facility: William Osler Health System (Brampton Civic Hospital) ( Site 0402)

location_facility: Antalya Memorial Hospital Department of Medical Oncology ( Site 0324)

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0203)

location_facility: Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz ( Site 0202)

location_facility: Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0185)

location_facility: West China Hospital of Sichuan University ( Site 0117)

location_facility: Policlinico Gemelli di Roma ( Site 0237)

location_facility: 1st Affil Hosp of Med College of Xi'an Jiaotong University ( Site 0103)

location_facility: Seoul National University Bundang Hospital ( Site 0075)

location_facility: McGill University Health Centre ( Site 0418)

location_facility: Hospital General de Medellin Luz Castro de Gutierrez ( Site 0368)

location_facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0374)

location_facility: Kyiv City Clinical Oncology Centre ( Site 0339)

location_facility: University of Missouri Health Care ( Site 0555)

location_facility: Akdeniz Universitesi Tip Fakultesi ( Site 0322)

location_facility: MI Odessa Regional Oncological Centre ( Site 0333)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 0369)

location_facility: Centre hospitalier Toulon Sainte-Musse ( Site 0172)

location_facility: Billings Clinic Cancer Center ( Site 0508)

location_facility: Kanagawa Cardiovascular and Respiratory Center ( Site 0026)

location_facility: Osaka International Cancer Institute ( Site 0019)

location_facility: Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0341)

location_facility: Hangzhou First People's Hospital ( Site 0109)

location_facility: National Taiwan University Hospital ( Site 0088)

location_facility: Centre Hospitalier de la Cote Basque ( Site 0173)

location_facility: Gulhane Egitim ve Arastirma Hastanesi ( Site 0316)

location_facility: Podillya Regional Center of Oncology ( Site 0343)

location_facility: SA Pohja-Eesti Regionaalhaigla ( Site 0162)

location_facility: Koo Foundation Sun Yat-Sen Cancer Center ( Site 0091)

location_facility: Presidio Ospedaliero San Vincenzo ( Site 0231)

location_facility: Cone Health Cancer Center at Alamance Regional ( Site 0527)

location_facility: City Clinical Hosp.4 of DCC ( Site 0338)

location_facility: The First Affiliated Hospital Zhejiang University ( Site 0106)

location_facility: Centrum Medyczne Pratia Ostroleka ( Site 0242)

location_facility: University of Kentucky School of Medicine & Hospitals ( Site 0517)

location_facility: The Prince Charles Hospital ( Site 0011)

location_facility: SMG-SNU Boramae Medical Center ( Site 0078)

location_facility: Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 0331)

location_facility: Anne Arundel Medical Center Oncology and Hematology ( Site 0514)

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 0217)

location_facility: National Hospital Organization Kyushu Medical Center ( Site 0015)

location_facility: Baskent Universitesi Ankara Hastanesi ( Site 0319)

location_facility: SA Tartu Ulikooli Kliinikum ( Site 0160)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0269)

location_facility: Alaska Clinical Research Center ( Site 0511)

location_facility: CHU de Grenoble - Hopital Michallon ( Site 0169)

location_facility: Institut Curie - Centre Rene Huguenin ( Site 0181)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0252)

location_facility: Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 0253)

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


acronym: Pembrolizumab plus Lenvatinib as First-line Intervention for Advanced Melanoma

summary:
The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) as first-line treatment in adults with no prior systemic therapy for their advanced melanoma.

The primary study hypotheses are that: 1) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), and 2) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Overall Survival (OS). For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.

location_facility: SRH Wald-Klinikum Gera GmbH ( Site 0042)

location_facility: LKH Universitatsklinikum Graz ( Site 0776)

location_facility: Istituto Nazionale Tumori Fondazione Pascale ( Site 0061)

location_facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0278)

location_facility: Cape Town Oncology Trials Pty Ltd ( Site 0803)

location_facility: Institut Claudius Regaud IUCT Oncopole ( Site 0003)

location_facility: Hopital Ambroise Pare Boulogne ( Site 0007)

location_facility: Tianjin Medical University Cancer Institute & Hospital ( Site 0606)

location_facility: Hospital Universitario Carlos Haya ( Site 0186)

location_facility: CHRU Lille - Hopital Claude Huriez ( Site 0004)

location_facility: Hadassah Ein Karem Hebrew University Medical Center ( Site 0305)

location_facility: Fujian Provincial Cancer Hospital ( Site 0612)

location_facility: Cancer Care Langenhoven Drive Oncology Centre ( Site 0805)

location_facility: OHSU Center for Health & Healing ( Site 0731)

location_facility: Hospital Universitario Ramon y Cajal ( Site 0183)

location_facility: St. Vincent Frontier Cancer Center ( Site 0724)

location_facility: Minnesota Oncology Specialist, PA ( Site 0766)

location_facility: University of Colorado Cancer Center ( Site 0708)

location_facility: Fudan University Shanghai Cancer Center ( Site 0607)

location_facility: Hospital Sao Vicente de Paulo ( Site 0396)

location_facility: Baptist MD Anderson Cancer Center ( Site 0767)

location_facility: Hospital de Caridade de Ijui ( Site 0391)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 0191)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0652)

location_facility: CHU de la Miletrie Poitiers ( Site 0011)

location_facility: McGill University Health Centre ( Site 0651)

location_facility: Instituto Nacional de Cancer Hospital do Cancer II ( Site 0394)

location_facility: Shamir Medical Center-Assaf Harofeh ( Site 0308)

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 0272)

location_facility: Universitaetsklinikum Wuerzburg-Department of Dermatology ( Site 0036)

location_facility: Inova Schar Cancer Institute ( Site 0739)

location_facility: Universitaetsklinikum Leipzig ( Site 0040)

location_facility: Sun Yat-Sen University Cancer Center ( Site 0602)

location_facility: Klinik fur Dermatologie Allergologie und Venerologie ( Site 0035)

location_facility: BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 0661)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0421)

location_facility: Hospital Universitario Insular de Gran Canaria ( Site 0189)

location_facility: Hospital Duran i Reinals ICO de Hospitalet ( Site 0187)

location_facility: Norrlands Universitetssjukhus ( Site 0216)

location_facility: Complejo Hospitalario Universitario A Coruna. CHUAC ( Site 0182)

location_facility: Kyungpook National University Chilgok Hospital ( Site 0553)

location_facility: Hospital Clinic i Provincial Barcelona ( Site 0190)

location_facility: The Angeles Clinic and Research Institute ( Site 0707)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0422)

location_facility: Seoul National University Hospital ( Site 0554)

location_facility: Sunnybrook Research Institute ( Site 0654)

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 0033)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0064)

location_facility: Sahlgrenska Universitetssjukhuset ( Site 0212)

location_facility: University of North Carolina - Cancer Hospital ( Site 0751)

location_facility: Sociedad Medica Aren y Bachero Limitada ( Site 0426)

location_facility: Sandton Oncology Medical Group PTY LTD ( Site 0802)

location_facility: Severance Hospital Yonsei University Health System ( Site 0552)

location_facility: Nanjing Drum Tower Hospital ( Site 0609)

location_facility: Medizinische Universitat Wien ( Site 0778)

location_facility: Guys and St Thomas NHS Foundation Trust ( Site 0126)

location_facility: Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 0273)

location_facility: Hospital Universitario La Paz ( Site 0184)

location_facility: Melanoma Institute Australia ( Site 0452)

location_facility: Karolinska Universitetssjukhuset ( Site 0211)

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0397)

location_facility: Centre Hospitalier Victor Dupouy ( Site 0012)

location_facility: Azienda Ospedaliera Universitaria Senese ( Site 0065)

location_facility: PERSONAL - Oncologia de Precisao e Personalizada ( Site 0399)

location_facility: Princess Alexandra Hospital ( Site 0454)

location_facility: Universitaetsklinikum Carl Gustav Carus ( Site 0041)

location_facility: Uniwersyteckie Centrum Kliniczne ( Site 0281)

location_facility: Universitaetsspital Zuerich ( Site 0092)

location_facility: Istituto Europeo di Oncologia ( Site 0067)

location_facility: California Pacific Medical Center Research Institute ( Site 0705)

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0704)

location_facility: Universitaetsklinikum Erlangen ( Site 0044)

location_facility: John Wayne Cancer Institute ( Site 0706)

location_facility: Centro Investigación del Cáncer James Lind ( Site 0425)

location_facility: The First Hospital Of Jilin University ( Site 0603)

location_facility: Hospital Universitario Marques de Valdecilla ( Site 0181)

title: A Phase 3 Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) and Lenvatinib (E7080/MK-7902) Versus Pembrolizumab Alone as First-line Intervention in Participants With Advanced Melanoma (LEAP-003)

source: euctr

location_country:
Germany
Italy
Poland
Israel
United Kingdom
Australia
Brazil
Sweden
Austria
Switzerland
United States
China
Korea, Republic of
Spain
South Africa
Chile
Canada
France


title: A Non-interventional Cross-sectional Study to Capture the Prevalence of Cardiovascular Disease in Patients With Type 2 Diabetes in Selected Countries in Europe

acronym: EU-CAPTURE

summary: The purpose of the study is to register the occurrence of cardiovascular disease among type 2 diabetes (T2DM) patients across five selected countries in Europe. Participants will be asked to give information about their health. Participants will continue their normal way of life and will not get any medication other than what has been prescribed to them by their doctor. Participants' participation will be one day/one visit at study doctor. The study will last for about 3 months in total.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

ReferenceType: result

ReferenceCitation: Mosenzon O, Alguwaihes A, Leon JLA, Bayram F, Darmon P, Davis TME, Dieuzeide G, Eriksen KT, Hong T, Kaltoft MS, Lengyel C, Rhee NA, Russo GT, Shirabe S, Urbancova K, Vencio S; CAPTURE Study Investigators. CAPTURE: a multinational, cross-sectional study of cardiovascular disease prevalence in adults with type 2 diabetes across 13 countries. Cardiovasc Diabetol. 2021 Jul 27;20(1):154. doi: 10.1186/s12933-021-01344-0.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repository_institution: University of Szeged - SZTE Publicatio Repozitórium - SZTE - Repository of Publications

version: acceptedVersion

repositories:
HAL
PubMed Central
publicatio.bibl.u-szeged.hu

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Vencio S, Vianna AGD, da Silva MACF, Precoma DB. Contemporary (2019) prevalence of cardiovascular disease in adults with type 2 diabetes in Brazil: the cross-sectional CAPTURE study. Diabetol Metab Syndr. 2022 Jan 10;14(1):5. doi: 10.1186/s13098-021-00775-9.

evidence: oa repository (via page says license)

repository_normalized: Research Square

version: submittedVersion

repositories:
PubMed Central
Research Square

repositories_concat: PubMed Central;Research Square

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S

location_country: Czechia Italy France

intervention_type: Other

status_simplified: Completed


title: Open-label Extension Study of Relamorelin for the Treatment of Diabetic Gastroparesis

summary: This open-label study is to assess the safety of continued treatment with relamorelin for participants who previously completed the RLM-MD-03 [NCT03420781] or RLM-MD-04 [NCT03383146] study and to provide treatment for these participants until relamorelin becomes commercially available or the Sponsor terminates development.

status: Terminated

ipd_sharing: No

lead_sponsor: Allergan

location_country:
Germany
Poland
Argentina
Australia
Brazil
Thailand
Canada
France
Colombia
Hungary
Denmark
United States
Latvia
Ukraine
India
Romania
Belgium
Malaysia
Philippines
Italy
United Kingdom
Singapore
Austria
Mexico
Korea, Republic of
Spain
South Africa
Bulgaria
Russian Federation
Israel

location_facility: Szpital Uniwestytetu Medycznego w Bialymstoku

location_facility: Regional Public Organization Chernivtsi Regional Endocrinology Center

location_facility: Universita degli Studi di Napoli Federico II

location_facility: Municipal Institution Lutsk City Clinical Hospital

location_facility: Carolina Digestive Health Associates, PA

location_facility: ClinTrial Medical Center, Pulmonology Department

location_facility: Chopda Medicare & Research Centre Pvt.Ltd, Magnum Heart Institute

location_facility: North-Western State Medical University named after I. I. Mechnikov

location_facility: Regional municipal institution "Chernivtsi's regional clinical hospital", gastroenterological department, Higher state educational establishment of Ukraine "Bukovinian state medical university", department of internal medicine and infectious diseases, c.C

location_facility: San Juan De Dios Educational Foundation, Inc.

location_facility: Pauls Stradins Clinical University Hospital, Endokrinologijas nodala

location_facility: Long Island Gastrointestinal Research Group LLP

location_facility: Gruppo Humanitas - Humanitas Research Hospital

location_facility: Hospices Civils de Lyon - Hôpital Edouard Herrriot

location_facility: University of North Carolina at Chapel Hill

location_facility: Woodholme Gastroenterology Associates, P.A.

location_facility: S.P.Medical College & Group of Hospitals Bikaner

location_facility: Municipal nonprofit entity "Chernigiv city hospital #2" of Chernigiv municipal council, therapeutic department

location_facility: Rocky Mountain Diabetes and Osteoporosis Center, PA

location_facility: Municipal nonprofit entity "Vinnytsia's city clinical hospital #1", gastroenterological department, Vinnytsia National Pirogov Memorial Medical University, department of propedeutics of internal medicine, c. Vinnytsia

location_facility: New Orleans Research Institute - Metropolitan Gastroenterology Associates

location_facility: Eternal Hospital, Unit of Eternal Heart Care Centre and Research Institute Pvt. Ltd.

location_facility: Unidad de Investigación Clínica Cardiometabolica de Occidente

location_facility: Digestive Health Specialist of the South East

location_facility: Faculty of Medicine, Siriraj Hospital, Mahidol University

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie

location_facility: SU Clinic of medical academy of SI Dnepropetrovsk medical cacadamy of MoH of Ukraine

location_facility: Innovative Research of West Florida, Inc.

location_facility: Clinical Endocrinology of SI V.Danilevsky Institute for endocrine pathology problems National Academy of Medical sciences of Ukraine

location_facility: Centro Especializado en Investigación Clínica S.C.

location_facility: Institute of Endocrinology and Metabolism im. V. P. Komisarenka NAMS Ukraine

location_facility: "Kryvyi Rih City Hospital #3" of Dnipropetrovsk Regional Council

location_facility: Grant Medical Foundation Ruby Hall Clinic

location_facility: Millitary-medical Academy, department of hospital therapy

location_facility: Centex Studies, Inc. - Lake Charles- Clinical Trials of SWLA, LLC

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion

location_facility: NZOZ Vita - Diabetica Malgorzata Buraczyk, Diabetes Clinic,

location_facility: NYU Winthrop Hospital, Clinical Trials Center

location_facility: Ternopil University Hospital, Regional Center for Gastroenterology with Hepatology, Department of Gastroenterology

location_facility: Specjalistyczny Gabinet Neurologiczny Marta Banach

location_facility: Unidad de Investigación clínica y atención Médica HEPA S.C.

location_facility: Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

location_facility: Family Medical Associates, Research Department

location_facility: Scientific Institute of Clinical and Experimental Lymphology

location_facility: Azienda Ospedaliera Rilievo Nazionale Alta Specialita (ARNAS) Garibaldi

location_facility: Dr. Anil K. Gupta Medicine Professional Corporation

location_facility: Markhot Ferenc Oktatokorhaz es Rendelointezet

location_facility: Southern Illinois University School of Medicine

location_facility: Private Small-Scale Enterprise Medical Center Pulse

location_facility: Kindred Medical Institute for Clinical Trials, LLC

location_facility: S.R. Kalla Memorial Gastro and General Hospital

location_facility: Texas Tech University Health Sciences, Center Division of Gastroenterology

location_facility: IRCCS S.Matteo Hospital Foundation, University of Pavia

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

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

location_facility: Toronto Western Hospital, University Health Network

location_facility: 6th City Clinical Hospital, c. Zaporizhzhia

location_facility: State Institution Ukrainian State Research Institute

location_facility: Connecticut Clinical Research Foundation

location_facility: Municipal nonprofit entity "City clinical hospital #2 n.a. Prof.O.O.Shalimov" of Kharkiv municipal council, department of endocrinology

location_facility: Biopharma Informatic Inc., Research Center

location_facility: Lifecare Clinic and Research Centre - Internal Med/Diabetolo

location_facility: Universitätsklinikum Giessen und Marburg GmbH

location_facility: Medical Center Universal Clinic OberigMedical Center Universal Clinic Oberig / Medical Center "Universal Clininc "Oberig" of LLC "Capital", Gastroenterological Center, c. Kyiv

location_facility: Hospital Universitário João de Barros Barreto - UFPA

location_facility: Oddzial Gastroenterologii Mazowieckie Centrum Rehabilitacji Stocer sp. Z o.o.

location_facility: West Visayas State University Medical Center

location_facility: Victoria Hospital Bangalore Medical College and Research Ins

location_facility: Professional Research Network of Kansas, LLC

location_facility: Instituto de Estudos e Pesquisas Clínicas do Ceará - IEP/CE - Oncology

location_facility: Odessa Railway Clinical Hospital of Branch of HC JSC Ukrzaliznytsia, Odessa National Medical University

location_facility: DRRI-Vinnytsia National Pirogov Memorial Medical University

location_facility: Hospital Universitario Principe de Asturias

location_facility: Limited Liability Company "Medical and Diagnostic Center "ADONIS Plus", outpatient department, c. Kyiv

location_facility: Policlinico Gemelli, Divisione di Endocrinologia e Malattie del Metabolismo

location_facility: Hospital Clinico Universitario San Carlos

location_facility: Instituto Catarinense de Endocrinologia e Diabetes (ICED)

location_facility: Clinical Applications Laboratories, Inc.

location_facility: Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research

location_facility: Synexus Helderberg Clinical Research Centre

location_facility: "State Institution "National Institute of Therapy named after. L.T. Maloi NAMNU" / Government Institution "L.T.Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine", Department of the study of diseases of the digestive

location_facility: B. J. Government Medical College and Sassoon General Hospitals

location_facility: Troy Gastroenterology, PC dba Center for Digestive Health

location_facility: Medical Center Asklepion - Humane Medicine Research EOOD

location_facility: Instituto de Investigaciones Clínicas de Rosario

location_facility: CIADEN (Centro de Investigación y Atención de Diabetes, Endocrinología y Nutrición)

location_facility: First Department of Medicine, University of Szeged

location_facility: Medical Center of the Limited Liability Company "Health Clinic", Medical Clinical Research Center, Department of Gastroenterology, Hepatology and Endocrinology

location_facility: The Ohio State University, Wexner Medical Center

location_facility: Torrance Clinical Research Institute, Inc.

location_facility: M. S. Ramaiah medical College and Hospitals - Gastroenterolo

location_facility: Centre Hospitalier de l'Universite de Montreal - CHUM

location_facility: Dr. Jivraj Mehta Smarak Health Foundation Bakeri Medical Res

location_facility: Vinnytsia Regional Clinical highly specialized Endocrinology Centre

location_facility: Instituto de hematología y medicina clínica "Dr. Rubén Dávoli"

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino

location_facility: Polyclinic of medical services and rehabilitation department of State Joint-Stock Holding Company Artem, day-patient unit

location_facility: Maffei Centro Medico-Investigacion Clinica Aplicada

location_facility: Service d'hépato-gastroentérologie - 7°D

location_facility: Centro Universitario de Investigacion en Farmacologia Clinic

location_facility: Family Practice Center of Wadsworth, Inc. DBA New Venture Medical Research

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

location_facility: Municipal Institution-Zaporizhzhia Regional Clinical Hospital

location_facility: Gastroenterology Associates of Western Michigan

location_facility: Nizhegorodsky Regional Clinical Hospital named after N. A. Semashko

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: "Municipal Institution ""City Hospital #7"", polyclinic department, c. Zaporizhzhia"

location_facility: Baylor College of Medicine Medical Center

location_facility: Oö. Gesundheits- und Spitals-AG/LKH Steyr

location_facility: SAGACT PLLC., San Antonio Gastroenterology Associates, PA

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Medical Research Center of Connecticut, LLC

location_facility: Surat Institute of Digestive Sciences Hospitals

location_facility: Mid Essex Hospital Services NHS Trust Broomfield Hospital

location_facility: Sanggye Paik Hospital, Inje University College of Medicine

location_facility: Ivano-Frankivsk National Medical University

location_facility: Ivano-Frankivsk Central City Clinical Hospital

location_facility: Centro de Investigacion Morales Vargas - CIMOVA

location_facility: Gastroenterology Associates of Fairfield County, P.C.

location_facility: Kyiv Railway Clinical Hospital #2 of Branch Healthcare Center of the PJSC Ukranian Railway, Endocrynology Department

location_facility: Madras Medical College & Rajiv Gandhi Govt. General Hospital

location_facility: Indiana University Health University Hospital

location_facility: Universita' Di Salerno- Aou Ruggi D'aragona

location_facility: Moscow Regional Research Clinical Institute named by MF Vladimirski

location_facility: Diabetes and Endocrinology Consultants, PC

location_facility: Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,

location_facility: Saint-Petersburg City Pokrovskaya Hospital

location_facility: Valley View Wellness and Medical Center - VVCRD Clinical Research

location_facility: Preferred Primary Care Physicians, Jacob Murphy

location_facility: Communal Institution Kherson City Clinical Hospital

location_facility: City Hospital #1, department of endocrinology, c. Mykolayiv

location_facility: Universidade de Sao Paulo (USP) - Hospital das Clinicas da F

location_facility: Instituto de Diabetes Obesidad y Nutrición SC

location_facility: M.V. Hospital for Diabetes & Diabetes Research Centre

location_facility: Royal Adelaide Hospital - Central Adelaide Local Health Network Incorporated

location_facility: Kyiv city clinical endocrinology center, department of general endocrine pathology and metabolism, c. Kyiv

location_facility: Instituto de Pesquisa Clínica em Campinas

location_facility: Communal Institution "Odesa Regional Clinical Hospital", Out-patient department

location_facility: FSBI National medical endocrinology research centre

status_simplified: Unknown


title: A Phase 3 Multicenter, Open-Label, Randomized, Controlled Study of Oral Infigratinib Versus Gemcitabine With Cisplatin in Subjects With Advanced/Metastatic or Inoperable Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations: The PROOF Trial

summary: Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor (FGFR) 2 and is being developed to treat participants with FGFR2 mutated cholangiocarcinoma. The purpose of the study is to evaluate the efficacy and safety of the investigational agent oral infigratinib vs standard of care chemotherapy (gemcitabine plus cisplatin) in first-line treatment of participants with unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion/rearrangement. Subjects will be randomized 2:1 to receive infigratinib or gemcitabine plus cisplatin.

ReferenceCitation: Makawita S, K Abou-Alfa G, Roychowdhury S, Sadeghi S, Borbath I, Goyal L, Cohn A, Lamarca A, Oh DY, Macarulla T, T Shroff R, Howland M, Li A, Cho T, Pande A, Javle M. Infigratinib in patients with advanced cholangiocarcinoma with FGFR2 gene fusions/translocations: the PROOF 301 trial. Future Oncol. 2020 Oct;16(30):2375-2384. doi: 10.2217/fon-2020-0299. Epub 2020 Jun 25.

oa_host_type: closed

ipd_sharing: Undecided

lead_sponsor: QED Therapeutics, Inc.

sponsor_collaborators:
QED Therapeutics, Inc.
Helsinn Healthcare SA

location_country:
Germany
Italy
Portugal
United Kingdom
Australia
Belgium
United States
China
Korea, Republic of
Spain
Thailand
Taiwan
Canada
Puerto Rico
France

location_facility: Hospital Universitario Vall d'Hebrón - PPDS

location_facility: Chang Gung Memorial Hospital - Kaohsiung

location_facility: Centro Hospitalar E Universitário de Coimbra EPE

location_facility: Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST

location_facility: Severance Hospital Yonsei University Health System

location_facility: Policlinico Universitario Campus Biomedico Di Roma

location_facility: University of Texas Southwestern Medical Center

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: The Christie NHS Foundation Trust - PPDS

location_facility: Hospital Oncologico, Puerto Rico Medical Center

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Maharaj Nakorn Chiang Mai Chiang Mai University

location_facility: Azienda Socio Sanitaria Territoriale di Cremona (ASST)

location_facility: Hopital Claude Huriez Rue Michel Polonovski (CHRU) Lille

location_facility: Cancer and Hematology Centers of Western Michigan

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

location_facility: Instituto Catalan de Oncologio ICO I'Hospitalet

location_facility: University of Arkansas for Medical Sciences

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Frederick Regional Healthcare Systems/James M. Stockman Cancer Institute

location_facility: Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Barbara Ann Karmanos Cancer Institute - Lawrence and Idell Weisberg Cancer Treatment Center

location_facility: Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.

location_facility: Seoul National University Bundang Hospital

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS

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

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Ohio State University Comprehensive Cancer Center

location_facility: Hospital Universitario HM Sanchinarro - CIOCC

location_facility: Instituto Português de Oncologia Francisco Gentil Centro Regional de Oncologia de Coimbra EPE

location_facility: University of Texas MD Anderson Cancer Center

location_facility: National Taiwan University Hospital - YunLin Branch

location_facility: Songklanagarind Hospital, Prince of Songkla University

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: UF Health Cancer Center at Orlando Health

location_facility: Complejo Asistencial Universitario de Salamanca - Hospital Clinico

location_facility: Peninsula & South Eastern Haematology and Oncology Group

location_facility: Centro Hospitalar do Porto - Hospital de Santo António


title: An Open Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (IMbrella B)

acronym: IMbrella B

summary: This is an open-label, multicenter, extension study. Patients who are receiving clinical benefit from atezolizumab monotherapy or atezolizumab in combination with other agent(s) or comparator agent(s) during participation in a Genentech or Roche-sponsored study (the parent study), who are eligible to continue treatment and who do not have access to the study treatment locally, may continue to receive study treatment in this extension study following roll-over from the parent study.

status: Recruiting

enrollment_type: Anticipated

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Poland
Australia
Brazil
Japan
Thailand
Chile
Czechia
Canada
France
Portugal
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
Latvia
Ukraine
Romania
Belgium
Italy
Guatemala
Norway
Singapore
United Kingdom
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Yale University School Of Medicine; Yale Cancer Center

location_facility: Levine Cancer Institute-Carolinas Medical Center

location_facility: Russian Oncology Research Center n.a. N.N. Blokhin

location_facility: Hôpital d'Instruction des Armées de Sainte Anne; Service de Pneumologie

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: Multiprofile Hospital for Active Treatment Serdika EOOD; Medical Oncology Department

location_facility: Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii

location_facility: Multiprofile Hospital for Active Treatment Central Onco Hospital OOD; Dept. of Medical Oncology

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Przychodnia Lekarska KOMED, Roman Karaszewski

location_facility: MI of the Lviv Regional Council Lviv Oncology Regional Treatment and Diagnostic Centre; Chemotherapy

location_facility: Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary; Sumy State Uni, Med Inst

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: Országos Onkológiai Intézet; Onkológiai Képalkotó és Invazív Diagnosztikai Központ

location_facility: Seoul National University College of Medicine, Liver Research Institute

location_facility: Orszagos Onkologiai Intezet; Borgyogyaszati Osztaly

location_facility: Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii

location_facility: St. Joseph Mercy Hospital; Cancer Care Center.

location_facility: University of Pittsburgh Medical Center Cancer Center; Investigational Drug Service

location_facility: Szegedi Tudományegyetem; Onkoterápiás Klinika

location_facility: Pecsi Tudomanyegyetem AOK; Borgyogyaszati Klinika

location_facility: Centro Integral Oncologico Clara Campal; Servicio de Oncología

location_facility: Phylasis Clinicas Research S de RL de CV; Sucursal Toluca

location_facility: Fort Wayne Medical Oncology and Hematology, Inc

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: University Of Chicago Medical Center; Section Of Hematology/Oncology

location_facility: Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia

location_facility: Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs

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

location_facility: University of Arkansas for Medical Sciences; Winthrop Rockefeller Cancer Institute

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz; Pulmonologiai Osztaly

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: University of Texas Health Sciences Center in San Antonio

location_facility: HonorHealth Research Institute - Pima - Virginia G. Piper Cancer Care Network

location_facility: Niigata University Medical & Dental Hospital

location_facility: Hospital Lucus Augusti; Servicio de Oncologia

location_facility: Riga's East Hosp Latvian Oncol; Medical Oncology

location_facility: University Hospital of Larissa; Oncology

location_facility: Pontificia Universidad Catolica de Chile; Centro Del Cáncer

location_facility: Petz Aladar Megyei Oktato Korhaz; Pulmonologiai Osztaly

location_facility: Hopital d'Instruction des Armees de Begin

location_facility: Hospital General Universitario Gregorio Mara

location_facility: CHU Timone; Centre d'Essais Précoces en Cancérologie de Marseille (CEPCM)

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Orszagos Onkologiai Intezet; "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály

location_facility: HM Sanchinarro ? CIOCC; Servicio de Oncologia

location_facility: Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca; Oncologie Medicala

location_facility: Narodny Onkologicky Ustav; Oddelenie klinickej onkologie A

location_facility: Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine

location_facility: St Georges University Hospitals NHS Foundation Trust

location_facility: Lungenfachklinik Immenhausen; Zentrum fur Pneumologie

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Ivanovo Regional Oncology Dispensary; Chemotherapy Department

location_facility: P.A. Herzen Oncological Inst. ; Oncology

location_facility: Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology

location_facility: Institutul Regional de Oncologie Iasi; Clinica de Hematologie

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii

location_facility: SCRI Florida Cancer Specialists North; Research Office North Region.

location_facility: Washington University School of Medicine

location_facility: The Prince Charles Hospital; Oncology Dept.

location_facility: Uniwersytecki Szpital Kliniczny w Poznaniu

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: University of Colorado; Anschutz Cancer Pavilion

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Asan Medical Center; Internal Dept / Gastorenterology

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: National Cancer Institute MOH of Ukraine

location_facility: Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii

location_facility: Asklepios-Fachklinik Muenchen-Gauting; Klinik Für Pneumologie

location_facility: ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department

location_facility: Univ of Alabama at Birmingham; UAB Comprehensive Cancer Ctr

location_facility: Mercy Hospital, a Campus of Plantation General Hospital

location_facility: SRH Wald-Klinikum Gera; Zentrum fur klinische Studien (ZKS)

location_facility: Municipal Institution Podilskiy Regional Center of Oncology; Department of Chemotherapy

location_facility: Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

location_facility: Masaryk?v onkologický ústav; Klinika komplexní onkologické pé?e

location_facility: SLK-Kliniken Heilbronn GmbH; Klinik für Innere Medizin III; Schwerpunkt Häma./Onko./Palliativm.

location_facility: Hospital Clínico Universitario de Valencia; Medical Oncology

location_facility: Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

location_facility: University Hospital Bratislava; Department of Oncology

location_facility: University of Washington - Seattle Cancer Care Alliance; Medical Oncology

location_facility: Memorial Sloan Kettering - Basking Ridge

location_facility: Krankenhaus Barmherzige Bruder Regensburg

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

location_facility: Universitätsklinikum Freiburg;Klinik für Innere Medizin I

location_facility: Universitätsklinik Tübingen; Frauenklinik & Poliklinik


acronym: PINTA

lead_sponsor: Galapagos NV

summary: This is a randomized, double-blind, parallel-group, placebo-controlled, multicenter, exploratory Phase 2 study including participants with Idiopathic Pulmonary Fibrosis (IPF), investigating GLPG1205 in addition to the local standard of care (defined as receiving nintedanib, pirfenidone, or neither nintedanib nor pirfenidone).

ReferenceType: background

ReferenceCitation: Strambu IR, Fagard L, Ford P, Van Der Aa T, De Haas-Amatsaleh A, Santermans E, Seemayer C. (2020). Idiopathic pulmonary fibrosis (IPF): observations from a Phase 2 trial of GLPG1205 (PINTA). Abstract for European Respiratory Society International Congress 7-9 September 2020.

location_facility: Spitalul Clinic de Pneumoftiziologie Iasi

location_facility: Institutul de Pneumoftiziologie Marius Nasta

location_facility: Klinički Bolnički Centar Zagreb - Klinika Za Plućne Bolesti Jordanovac

location_facility: Dnipropetrovsk State Medical Academy - Dnipropetrovsk City Clinical Hospital No. 6

location_facility: National Oncology Centre - The Royal Hospital Muscat

location_facility: Municipal Institution "Kherson city clinical hospital named after E.E. Karabelesh"

location_facility: Spitalul Clinic De Pneumoftiziologie Leon Daniello Cluj-Napoca

location_facility: Acibadem City Clinic Tokuda Hospital, EAD

location_facility: Vinnitsa Regional Clinical Hospital im. N.I. Pirogov

location_facility: SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.

location_facility: Akademiska Sjukhuset - Uppsala Centrum for Cystisk Fibros

location_facility: Helsinki University Hospital Heart and Lung Center

location_facility: Specialized Hospital for Active Treatment Pleven

location_facility: Hôpital Européen Georges Pompidou (HEGP)

location_facility: Communal Nonprofit Enterprise City Clinical Hospital

location_facility: Hôpitaux Prives de Metz (HPMetz) - Hôpital Robert Schuman

location_facility: The Ivano-Frankivsk National Medical Univeristy

location_facility: National Institute of Phthisiology and Pulmonology named after F.G. Yanovskyi of NAMS of Ukraine

location_facility: National Institute of Tuberculosis, Pulmonary Diseases and Chest Surgery

title: A Phase II Randomized, Double-blind, Placebo-controlled, 26-week Study to Evaluate the Efficacy, Safety and Tolerability of GLPG1205 in Subjects With Idiopathic Pulmonary Fibrosis

location_country: Finland Slovakia Romania Sweden Croatia Oman Bulgaria Ukraine France


acronym: DESTINATION

lead_sponsor: AstraZeneca

summary: Subjects who completed either D5180C00007 or D5180C00009 will be offered the opportunity to consent for the Multicentre, Double-blind, Randomized, Placebo Controlled, Parallel Group, Phase 3, Safety Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma. The study consists of a treatment phase, followed by a follow-up phase where subjects will not receive IP. The length of the follow up phase is determined by which study the subject had previously completed.

ReferenceCitation: Menzies-Gow A, Ponnarambil S, Downie J, Bowen K, Hellqvist A, Colice G. DESTINATION: a phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the long-term safety and tolerability of tezepelumab in adults and adolescents with severe, uncontrolled asthma. Respir Res. 2020 Oct 21;21(1):279. doi: 10.1186/s12931-020-01541-7.

repositories_concat: PubMed Central

sponsor_collaborators: AstraZeneca Amgen

title: A Multicentre, Double-blind, Randomized, Placebo Controlled, Parallel Group, Phase 3, Safety Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe Uncontrolled Asthma (DESTINATION)

location_country:
Germany
Poland
Israel
Argentina
Australia
Brazil
Austria
United States
Korea, Republic of
Saudi Arabia
Vietnam
South Africa
Turkey
Taiwan
Canada
Ukraine
Russian Federation
France


acronym: SPROUT

lead_sponsor: Amgen

summary:
This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in pediatric subjects with moderate to severe plaque psoriasis.

At least 230 pediatric subjects (ages 6 through 17 years) will be randomized 2:1 to receive either apremilast or placebo for the first 16 weeks and then all subjects will receive apremilast during the 36 week Extension Phase for a total of 52 weeks. Randomization to apremilast arm or placebo arm will be stratified by age group (6 to 11 years or 12 to 17 years). Subjects will receive apremilast treatment of either 20 mg twice daily (BID) or 30 mg BID, depending on weight. This Phase 3 study is being conducted to evaluate the safety and efficacy of apremilast in the treatment of pediatric subjects.

location_facility: J Woodson Dermatology and Associates Ltd

location_facility: Centre Hospitalier Universitaire Saint Pierre

location_facility: Azienda Ospedaliera di Reggio Emilia Arcispedale Santa Maria Nuova

location_facility: University of South Florida Health Morsani Center for Advanced Healthcare

location_facility: Ural Scientific Research Institute of Dermatovenereology and Immunopathology

location_facility: Saint Petersburg State Pediatric Medical University

location_facility: Clinical Dispensary of Dermatology and Venereology of Krasnodar Territory of the Ministry of Health

location_facility: Cincinnati Childrens Hospital Medical Center

location_facility: Azienda Ospedaliero Universitaria Di Bologna Policlinico S Orsola Malpighi

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

location_facility: State Scientific Center for Dermatovenereology and Cosmetology

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: Pierre Wolkenshtein Skin Diseases Clinic LLC

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: National Medical Research Center for Children's Health

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Moscow Scientific Practical Center of Dermatology Venerology and Cosmetology

location_facility: Hospital General Universitario de Alicante

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Azienda Ospedaliera Universitaria di Cagliari

location_facility: Chelyabinsk Regional Clinical Skin and Venereal Dispensary

location_facility: Centre Hospitalier de Cornouaille - Hopital Laennec

location_facility: Hospital Universitari Germans Trias i Pujol Can Ruti

location_facility: Istituto Dermatologico San Gallicano IRCCS Dermatologia Clinica

location_facility: Republican Clinical Dermatology and Venerology Dispensary

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Centre Hospitalier Victor Dupouy Argenteuil

title: A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN PEDIATRIC SUBJECTS FROM 6 THROUGH 17 YEARS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

location_country:
Italy
Israel
Netherlands
Belgium
United States
Spain
Czechia
Canada
Russian Federation
France


summary: This study will evaluate the efficacy, safety, and pharmacokinetics of baloxavir marboxil in combination with a standard-of-care (SOC) neuraminidase inhibitor (NAI) (i.e., oseltamivir, zanamivir, or peramivir) compared with a matching placebo in combination with a SOC NAI in hospitalized patients with influenza.

ReferenceCitation: Stannard HL, Mifsud EJ, Wildum S, Brown SK, Koszalka P, Shishido T, Kojima S, Omoto S, Baba K, Kuhlbusch K, Hurt AC, Barr IG. Assessing the fitness of a dual-antiviral drug resistant human influenza virus in the ferret model. Commun Biol. 2022 Sep 28;5(1):1026. doi: 10.1038/s42003-022-04005-4.

ReferenceCitation: Kumar D, Ison MG, Mira JP, Welte T, Hwan Ha J, Hui DS, Zhong N, Saito T, Katugampola L, Collinson N, Williams S, Wildum S, Ackrill A, Clinch B, Lee N. Combining baloxavir marboxil with standard-of-care neuraminidase inhibitor in patients hospitalised with severe influenza (FLAGSTONE): a randomised, parallel-group, double-blind, placebo-controlled, superiority trial. Lancet Infect Dis. 2022 May;22(5):718-730. doi: 10.1016/S1473-3099(21)00469-2. Epub 2022 Jan 24.

publisher_dissemination: Elsevier

ReferenceCitation: Young B, Tan TT, Leo YS. The place for remdesivir in COVID-19 treatment. Lancet Infect Dis. 2021 Jan;21(1):20-21. doi: 10.1016/S1473-3099(20)30911-7. Epub 2020 Nov 26. No abstract available.

oa_colors: green other

evidence: open (via free pdf)

unpaywall_oa_status: bronze

location_facility: Regional Municipal Institution Sumy Regional Infectious Clinical Hospital n.a. Z.Y. Krasovytskyi

location_facility: Hospital Universitario Fundacion Jimenez Diaz.

location_facility: Multiprofile Hospital for Active Treatment - Samokov EOOD

location_facility: Uniklinik Koln; Klinik I fur Innere Medizin

location_facility: Hospital Universitario Marques de Valdecilla

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

location_facility: Japan Community Health care Organization Nihonmatsu hospital

location_facility: National Hospital Organization Minami Kyoto Hospital

location_facility: Kuopion Yliopistollinen Sairaala; Silmätaudit

location_facility: Spitalul Clinic de Boli Infectioase "Sfanta Parascheva" Iasi

location_facility: University Mulitiprofile Hospital for Active Treatment Sveti Georgi EAD; Pharmacy

location_facility: Regional Municipal Institution Chernivtsi Regional Clinical Hospital

location_facility: Royal Brisbane & Womens Hospital; Pharmacy Department

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases Dr. D. Gramatikov - Ruse

location_facility: Canisius Wilhelmina Ziekenhuis; Department Hematology

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: Sf. Ioan cel Nou Emergency County Hospital

location_facility: Skånes Universitetssjukhus Malmö; Infektionskliniken

location_facility: Hopital Erasme; Chest Medicine, Cardiac & Thoracic Surgery

location_facility: Salem Veterans Affairs Medical Center - NAVREF; Pharmacy

location_facility: Froedtert and The Medical College of Wisconsin

location_facility: Hallym University Kangnam Sacred Heart Hospital

location_facility: Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)

location_facility: Hospital General Universitario Reina Sofia; Servicio de Nefrologia

location_facility: Fifth Multiprofile Hospital for Active Treatment - Sofia EAD; Pharmacy

location_facility: MI Vinnytsia Regional Clinical Children's Infectious Hospital; Infectiuos Box department

location_facility: Municipal Institution City Clinical Infectious Diseases Hospital

location_facility: Communal Non-Commercial Enterprise "Vinnytsia City Clinical Hospital №1"; Infectious Department

location_facility: Cliniques Universitaires Saint-Luc; Hematology

location_facility: Prof. Dr. Matei Bals Institute of Infectious Diseases

location_facility: Royal Children's Hospital Melbourne - PIN

location_facility: New York-Presbyterian Brooklyn Methodist Hospital; Department of Emergency Medicine

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Hospital Civil Fray Antonio Alcalde; Instituto de Patologia Infecciosa

location_facility: Klinikum Mannheim GmbH Universitätsklinikum

location_facility: Multiprofile Hospital For Active Treatment - Dr. Bratan Shukerov AD; Pharmacy

location_facility: General Hospital Dr Radivoj Simonovic Sombor

location_facility: Multiprofile Hospital For Active Treatment Sveta Ekaterina Dimitrovgrad EOOD; Internal Diseases

location_facility: Clinical Center Nis; Clinic for Pulmonary Diseases and Tuberculosis Knez Selo

location_facility: London Health Sciences Center; Pharmacy Dept.

location_facility: Chaim Sheba Medical Center; Allergy and Clinical Immunology Unit

location_facility: Sibiu Emergency Clinical County Hospital

location_facility: National Hospital Organization Ibarakihigashi National Hospital; Center for Clinical Research

location_facility: Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases-Vratsa; Pharmacy

location_facility: Social Corporation Keigakukai Minamiosaka Hosupital

location_facility: Groupe Hospitalier Pitie Salpetriere; Service De Pneumologie

location_facility: Hospital Universitario Dr. Jose Eleuterio González; Enfermedades Pulmonares Crónicas

location_facility: Toronto East General Hospital; Main Pharmacy G Wing Basement

location_facility: Kyiv Oleksandrivska Clinical Hospital; Infectious Box Department #2

location_facility: Local incorporated administrative agency Shizuoka City Shizuoka Hospital

location_facility: Washington University School of Medicine

location_facility: Seoul National University Bundang Hospital

location_facility: Specialized Hospital for Active Treatment of Pneumophthisiatric Diseases - Haskovo EOOD

location_facility: National Multiprofile Transport Hospital Tzar Boris Ill; Clinic of Internal Diseases

location_facility: Hospital Nacional Adolfo Guevara Velasco - ESSALUD; Servicio de Cardiología

location_facility: Santa Casa de Misericordia; de Belo Horizonte

location_facility: Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran; Hamatologia y Oncologia

location_facility: Multiprofile Hospital For Active Treatment Sliven То Military Hospital Sofia; Pharmacy

location_facility: Oulun Yliopistollinen Sairaala; Teho-osasto

location_facility: Ternopil City Municipal Emergency Hospital; Infectious Department

location_facility: St. Josefskrankenhaus - Freiburg; Klinik fur Pneumologieund Beatmungsmedizin

location_facility: Temple University Hospital ; Lung Center

location_facility: National Hospital Organaization Shibukawa Medical Center

location_facility: Selcuk University Medical Faculty; Internal Medicine

location_facility: Hospital Sant Joan de Deu - PIN; Unitat de Recerca - Farmacia

location_facility: Multiprofile District Hospital for Active Treatment Dr. Stefan Cherkezov AD; Pharmacy

location_facility: Tel Aviv Sourasky Medical Center; Pharmacy

location_facility: Atlanta Institute For Medical Research, Inc; DeKalb Medical Pharmacy

location_facility: Nagata Hospital; Department of pulmonary medicine

location_facility: Sf.Cuv. Parascheva Infectious Diseases Clinical Hospital

location_facility: Centro de Estudos Clinicos do Interior Paulista

location_facility: Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika

location_facility: Centre Hospitalier Departemental de Vendee

location_facility: Beijing Ditan Hospital Capital Medical University

location_facility: National Hospital Organization Kanazawa Medical Center

location_facility: Zuyderland Medisch Centrum - Sittard Geleen

location_facility: Institut Universitaire de Cardiologie et de Pneumologie

location_facility: Beijing Youan Hospital, Capital Medical University; Center for Infectious Diseases

location_facility: First Multiprofile Hospital for Active Treatment - Sofia EAD

location_facility: Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia; Pharmacy

location_facility: Baruch Padeh Poria Medical Center; Pharmacy

location_facility: ZIV Medical Center; Department Of Internal Medicine A

location_facility: MI Dnipropetrovsk City Clinical Hospital #21 n.a. Prof. Popkova of DRC; The First Department

location_facility: Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai

location_facility: Krankenhaus Donaustauf der LVA Niederbayern Oberpfalz

location_facility: The First Affiliated Hospital of College of Medicine, Zhejiang University

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Karadeniz Technical University Faculty of Medicine

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

location_facility: The 1st Affiliated Hospital of Nanchang Unversity

location_facility: Leids Universitair Medisch Centrum; C5-P Stafcentrum Hartziekten

location_facility: Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I

location_facility: Dr. Victor Babes Clinical Hospital For Tropical and Infectious Diseases

location_facility: Rambam Health Corporation; Oncology Institute

title: A Phase III, Randomized, Double-Blind Placebo-Controlled, Multicenter Study To Evaluate the Efficacy and Safety of Baloxavir Marboxil in Combination With Standard-of-Care Neuraminidase Inhibitor in Hospitalized Participants With Severe Influenza

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:
Finland
Germany
New Zealand
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
Serbia
France
Hong Kong
United States
Ukraine
Romania
Belgium
China
Peru
Estonia
Singapore
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
Bulgaria
Israel


title: A Phase 3, Multicenter, Randomized, Double-blind Study of the Efficacy and Safety of Rezafungin for Injection vs. Intravenous Caspofungin Followed by Oral Fluconazole Step Down in the Treatment of Subjects With Candidemia and/or Invasive Candidiasis

acronym: ReSTORE

summary: The purpose of this pivotal study is to determine if intravenous Rezafungin is efficacious and safe in the treatment of candidemia and/or invasive candidiasis when compared to caspofungin (followed by optional oral fluconazole).

ReferenceCitation: Ham YY, Lewis JS 2nd, Thompson GR 3rd. Rezafungin: a novel antifungal for the treatment of invasive candidiasis. Future Microbiol. 2021 Jan;16(1):27-36. doi: 10.2217/fmb-2020-0217.

lead_sponsor: Cidara Therapeutics Inc.

location_country:
Germany
Italy
Colombia
Israel
Argentina
Singapore
Australia
Belgium
United States
China
Korea, Republic of
Spain
Greece
Thailand
Turkey
Taiwan
Bulgaria
France

location_facility: Integrated University Health Authority of Trieste

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Centre Hospitalier Victor Dupouy - Argenteuil

location_facility: University Hospital Vall d'Hebron (HUVH)

location_facility: Johannes Gutenberg University Medical Center

location_facility: Marmara University Pendik Training and Research Hospital

location_facility: Paris University Hospitals Center - Cochin Hospital

location_facility: Polyclinic S. Orsola-Malpighi, Dept. of Organ Impairment and Transplants

location_facility: University Hospital Germans Trias i Pujol

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: University Multiprofile Hospital for Active Treatment and Emergency Medicine N.I. Pirogov EAD, Sofia, Clinic of Purulent-Septic Surgery

location_facility: University Polyclinic Hospital "Paolo Giaccone" Palermo, Infectious Disease Department, ICU

location_facility: Marseille University Hospital Center - North Hospital

location_facility: University of Pittsburgh Falk Medical Center

location_facility: General Hospital of Athens "Laikon", Infectious Diseases Unit

location_facility: University and Polytechnic Hospital La Fe

location_facility: University Polyclinic Foundation Agostino Gemelli - IRCCS

location_facility: University of Milano-Bicocca - San Gerardo Hospital

location_facility: General Hospital of Athens "Evangelismos", 5th Department of Internal Medicine and Infectious Diseases Unit

location_facility: Alexander Fleming Specialized Medical Institute

location_facility: Multiprofile Hospital for Active Treatment Puls

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Tours University Hospital Center, Bretonneau Hospital

location_facility: Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

location_facility: Hotel Dieu Hospital Nantes University Hospital Center

location_facility: University Hospitals Leuven, Campus Gasthuisberg

location_facility: General Hospital of Thessaloniki Ippokratio

location_facility: University Polyclinic Hospital of Modena

location_facility: Amiens Picardie University Hospital - South

location_facility: Hospital del Mar, Department of Infectious Diseases

location_facility: General University Hospital Gregorio Maranon

location_facility: The Second Xiangya Hospital of Central South University

location_facility: Huashan Hospital Affiliated Fudan University

location_facility: General Hospital of Tianjin Medical University

location_facility: ASST Large Metropolitan Hospital Niguarda, Infectious Diseases Department

location_facility: The First Affiliated Hospital of Bengbu Medical College

location_facility: University of Mississippi Medical Center

location_facility: The University of Texas Health Science Center at San Antonio

location_facility: The Second Hospital of Anhui Medical University

location_facility: Integrated University Hospital "Santa Maria della Misericordia" of Udine

location_facility: University Hospital Puerta de Hierro Majadahonda


title: A Randomized Clinical Trial of Andexanet Alfa in Acute Intracranial Hemorrhage in Patients Receiving an Oral Factor Xa Inhibitor

summary: Randomized, controlled clinical trial evaluating the efficacy and safety of andexanet alfa versus usual care in patients with intracranial hemorrhage anticoagulated with a direct oral FXa anticoagulant

lead_sponsor: Alexion Pharmaceuticals, Inc.

location_country:
Finland
Germany
Poland
Czechia
Canada
France
Lithuania
Portugal
Hungary
Denmark
Switzerland
United States
Latvia
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Spain
Greece
Israel


title: GRAVITAS-309: A Phase 2/3 Study of Itacitinib and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

summary: The purpose of this study is to assess the efficacy and safety of itacitinib in combination with corticosteroids as first-line treatment for moderate or severe chronic graft-versus-host disease (cGVHD).

ipd_sharing_description:
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a 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 applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

lead_sponsor: Incyte Corporation

location_country:
Finland
Germany
Italy
Poland
Israel
United Kingdom
Denmark
Sweden
Switzerland
Austria
Belgium
United States
Spain
Greece
Canada
France

location_facility: Hadassah Hebrew University Medical Center Ein Karem Hadassah

location_facility: Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

location_facility: L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA ï¿½ MALPIGHI

location_facility: Fondazione Irccs Ca Granda Ospedale Maggiore

location_facility: Hospital Universitario Y Politcnico de La Fe

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: University of Maryland - Greenebaum Cancer Center

location_facility: Chru Hopitaux de Tours Hospital Bretonneau

location_facility: Texas Oncology - Baylor Sammons Cancer Center

location_facility: Selbststandige Abteilung Fur Hamatologie Und Internistische Onkologie

location_facility: University of Rochester, James P. Wilmot Cancer Center

location_facility: General Hospital of Thessaloniki G. Papanikolaou

location_facility: Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza

location_facility: Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele

location_facility: University of Arizona Cancer Center - Out Pt.

location_facility: University Hospitals Cleveland Medical Center

location_facility: St. George'S University Hospitals Nhs Foundation Trust

location_facility: Chu de Grenoble - Hopital Albert Michallon

location_facility: Szpital Kliniczny Przemienienia Panskiego

location_facility: University of Miami Sylvester Comprehensive Cancer Center

location_facility: Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu

location_facility: Nottingham University Hospitals Nhs Trust

location_facility: Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo

location_facility: University of Pennsylvania Abramson Cancer Center

location_facility: Universitaetsklinikum Erlangen - Medizinische Klinik 5

location_facility: Hospital Clinico de Santiago de Compostela

location_facility: Azienda Ospedaliera Ospedali Riuniti "Villa Sofia - Cervello"

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: University Hospital of West Attica - Attikon

location_facility: Winship Cancer Institute of Emory University

location_facility: Iii Medizinische Klinik Und Poliklinik Klinikum Rechts Der Isar Technische Universitat Munchen

location_facility: CENTRE HOSPITALIER UNIVERSITAIRE DE LIï¿½GE - SART TILMAN

location_facility: I.R.C.C.S. Casa Sollievo Della Sofferenza

location_facility: Imperial College Healthcare Nhs Trust - Hammersmith Hospital

location_facility: Advocate Lutheran General Hospital - Oncology Specislists Sc

location_facility: Hospital Regional Universitario de Malaga

location_facility: King'S College Hospital (Nhs Foundation)

location_facility: Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

location_facility: Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial W Gliwi

location_facility: Universita Degli Studi Di Roma La Sapienza - Umberto I Policlinico Di Roma - Centro Di Ematologia

location_facility: The Royal Marsden Nhs Foundation Trust - Sutton

location_facility: University Medical Centre Hamburg-Eppendorf Centre of Oncology

location_facility: University of Arkansas For Medical Sciences - Winthrop P Rockefeller Cancer Institute

location_facility: Hospital Clinico Universitario de Valencia

location_facility: University of California San Diego Medical Center, Moores Cancer Center

location_facility: Azienda Ospedaliera Bianchi-Melacrino-Morelli Ospedali Riuniti

location_facility: Hospital Universitario Virgen de Las Nieves

location_facility: Universitaire Ziekenhuis Leuven - Gasthuisberg

location_facility: Augusta University - Medical College of Georgia

location_facility: University Clinic Carl Gustav Carus Technical University Dresden

location_facility: Azienda Ospedaliero-Universitaria Santa Maria Della Misericordia

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Centro Ricerche Cliniche Di Verona (Crc)

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Barts Health Nhs Trust - St Bartholomews Hospital

location_facility: CLINICA DI EMATOLOGIA, UNIVERSITï¿½ POLITECNICA DELLE MARCHE

location_facility: Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

location_facility: University of Minnesota, Masonic Cancer Center

location_facility: Indiana University Melvin and Bren Simon Cancer Center


title: A Phase 3, Multicenter, Randomized, Open Label Study of Venetoclax and Dexamethasone Compared With Pomalidomide and Dexamethasone in Subjects With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma

summary: A study designed tocompare progression-free survival (PFS) in participants with t(11;14)-positive MM treated with venetoclax in combination with dexamethasone versus pomalidomide in combination with dexamethasone.

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

lead_sponsor: AbbVie

sponsor_collaborators: AbbVie Roche-Genentech

location_country:
Germany
Australia
Japan
Turkey
Czechia
Canada
France
Denmark
United States
Ukraine
China
Italy
United Kingdom
Singapore
Sweden
Korea, Republic of
Spain
Greece
Russian Federation
Israel

location_facility: Research Institute of Fundamental and Clinical Immunology /ID# 223594

location_facility: Yonsei University Health System Severance Hospital /ID# 202709

location_facility: The First Affiliated Hospital of Soochow University /ID# 216094

location_facility: VA Central California Health Care System /ID# 200047

location_facility: Ege University Medical Faculty /ID# 222697

location_facility: The Queen Elizabeth Hospital /ID# 202432

location_facility: CHU Reims - Hôpital Robert Debre /ID# 233907

location_facility: Hospital Universitario Virgen del Rocio /ID# 171286

location_facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 171255

location_facility: Istanbul University Istanbul Medical Faculty /ID# 201953

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 212498

location_facility: Universitaetsklinikum Hamburg-Eppendorf /ID# 215495

location_facility: Bagcilar Medipol Mega Universite Hastanesi /ID# 222914

location_facility: Manchester University NHS Foundation Trust /ID# 171440

location_facility: Imperial College Healthcare NHS Trust /ID# 171446

location_facility: Tianjin Medical University Cancer Institute & Hospital /ID# 223550

location_facility: Nottingham University Hospitals NHS Trust /ID# 223292

location_facility: Duplicate_Universitetssjukhuset Linköping /ID# 200789

location_facility: Beijing Chaoyang Hospital,Capital Medical University /ID# 216014

location_facility: The First Affiliated Hospital of Wenzhou Medical University /ID# 218953

location_facility: Peking University Third Hospital /ID# 216371

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 201830

location_facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 213982

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 170950

location_facility: Assuta Ashdod Medical Center /ID# 222968

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi /ID# 201956

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust /ID# 171447

location_facility: Japanese Red Cross Osaka Hospital /ID# 171493

location_facility: Duplicate_Duplicate_Lewisham and Greenwich NHS Trust /ID# 171445

location_facility: Iwate Medical University Hospital /ID# 222849

location_facility: Universitaetsklinikum Tuebingen /ID# 238646

location_facility: University Gen Hosp of Patra /ID# 201691

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 234045

location_facility: Universitaetsklinikum Wuerzburg /ID# 200055

location_facility: Tokushima University Hospital /ID# 202571

location_facility: Kobe City Medical Center General Hospital /ID# 170992

location_facility: VA Puget Sound Health Care System /ID# 222708

location_facility: Odense Universitets Hospital /ID# 223217

location_facility: Moscow State budget healthcare /ID# 169685

location_facility: Hospital Universitario Canarias /ID# 238452

location_facility: Barbara Ann Karmanos Cancer In /ID# 201377

location_facility: Gazi University Medical Faculty /ID# 222698

location_facility: Tula Regional Clinical Hospital /ID# 223226

location_facility: Shengjing Hospital of China Medical University /ID# 223435

location_facility: The First Hospital of China Medical University /ID# 215996

location_facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 216041

location_facility: Guangdong Provincial People's Hospital /ID# 215860

location_facility: Peking Union Medical College Hospital /ID# 216040

location_facility: Rocky Mountain Regional VA Medical Center/Eastern Colorado Health Care System /ID# 222904

location_facility: Vseobecna fakultni nemocnice v Praze /ID# 221166

location_facility: University of California, Los Angeles /ID# 171524

location_facility: Soroka University Medical Center /ID# 218768

location_facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215989

location_facility: Gachon University Gil Medical Center /ID# 202827

location_facility: Azienda Ospedaliera Santa Maria Terni /ID# 170948

location_facility: The Lady Davis Carmel Medical Center /ID# 222969

location_facility: Nagoya City University Hospital /ID# 170880

location_facility: Columbia University Medical Center /ID# 200715

location_facility: Hospital Universitari Son Espases /ID# 222889

location_facility: National University Hospital /ID# 203988

location_facility: CISSS-CA (Centre Integre de sante et de services sociaux de Chaudiere-Appalache) /ID# 218887

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 201952

location_facility: Seoul National University Hospital /ID# 202711

location_facility: Hospital Universitario y Politecnico La Fe /ID# 234019

location_facility: General Hospital of Thessaloniki George Papanikolaou /ID# 201692

location_facility: A.O.U. Citta della Salute e della Scienza di Torino /ID# 170962

location_facility: Theageneio Anticancer Hospital /ID# 213983

location_facility: MNI Khmelnytskyi Regional Hospital of Khmelnytskyi Regional Council /ID# 223942

location_facility: Japanese Red Cross Medical Center /ID# 171256

location_facility: CHU Grenoble - Hopital Michallon /ID# 223182

location_facility: Leningrad Regional Clinical Hospital /ID# 202776

location_facility: Fairview Hospital - Moll Pavilion /ID# 208919

location_facility: Sun Yat-Sen University Cancer Center /ID# 223828

location_facility: Instituto Catalan de Oncologia (ICO) Girona /ID# 171311

location_facility: Beijing Chaoyang Hospital, Capital Medical University(West campus) /ID# 234033

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 216643

location_facility: Almazov National Medical Research Centre /ID# 169681

location_facility: Hospital Universitario 12 de Octubre /ID# 171288

location_facility: West China Hospital, Sichuan University /ID# 216647

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 171304

location_facility: Communal Nonprofit Enterprise Cherkasy Regional Oncology Dispensary /ID# 223943

location_facility: University College London Hospitals NHS Foundation Trust /ID# 171428

location_facility: A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 222988

location_facility: Communal non-profit enterprise Regional Center of Oncology /ID# 223945

location_facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 218691

location_facility: ICON Cancer Care - Townsville /ID# 206565

location_facility: Hospital General Universitario de Toledo Complejo Hosp. de Toledo /ID# 222887

location_facility: Complejo Hospitalario Universitario Ourense /ID# 222876

location_facility: The Jikei University Kashiwa Hospital /ID# 223031

location_facility: Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 200051

location_facility: Hospital Universitario La Paz /ID# 218107

location_facility: University of Arizona Cancer Center - North Campus /ID# 218407

location_facility: Tel Aviv Sourasky Medical Center /ID# 169437

location_facility: NHS Greater Glasgow and Clyde /ID# 202199

location_facility: SI Institute of Blood Pathology and Transfusion Medicine of NAMS of Ukraine /ID# 223941

location_facility: Portsmouth Hospitals University NHS Trust /ID# 171444

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 222879

location_facility: MD Anderson Cancer Center at Texas Medical Center /ID# 200060

location_facility: The First Affiliated Hospital of Nanchang University /ID# 216954

location_facility: Izmir Ekonomi Universitesi Ozel Medicalpoint Hastanesi /ID# 201954

location_facility: Cambridge University Hospitals NHS Foundation Trust /ID# 223097

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 170952

location_facility: Cukurova Universitesi Tip Fakultesi /ID# 201955

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 202213

location_facility: CHRU Nancy - Hopitaux de Brabois /ID# 201076

location_facility: University of Maryland School of Medicine /ID# 217422

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 200099

location_facility: The Chaim Sheba Medical Center /ID# 169778

location_facility: University Hospitals of North Midlands NHS Trust /ID# 218355

location_facility: National Hospital Organization Mito Medical Center /ID# 171187

location_facility: The Jikei University Hospital /ID# 239014

location_facility: QE II Health Sciences Centre /ID# 218883

location_facility: Yamagata University Hospital /ID# 238329

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 218213

location_facility: Royal Berkshire NHS Foundation Trust /ID# 217835

location_facility: Cleveland Clinic Main Campus /ID# 202247

location_facility: Hospital Universitario de Salamanca /ID# 171294

location_facility: Fakultni nemocnice Hradec Kralove /ID# 221291

location_facility: Hospital Universitario Vall d'Hebron /ID# 218106

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 215850


title: A Phase III Multicenter Open-label Randomized Trial to Evaluate Efficacy and Safety of Folfirinox (FFX) Versus Combination of CPI-613 With Modified Folfirinox (mFFX) in Patients With Metastatic Adenocarcinoma of the Pancreas

summary: A prospective, multicenter, open label, randomized phase III study to evaluate efficacy and safety of FFX versus CPI-613 + mFFX in patients with metastatic adenocarcinoma of the pancreas with age range of 18 to 75 years

ReferenceCitation: Philip PA, Buyse ME, Alistar AT, Rocha Lima CM, Luther S, Pardee TS, Van Cutsem E. A Phase III open-label trial to evaluate efficacy and safety of CPI-613 plus modified FOLFIRINOX (mFFX) versus FOLFIRINOX (FFX) in patients with metastatic adenocarcinoma of the pancreas. Future Oncol. 2019 Oct;15(28):3189-3196. doi: 10.2217/fon-2019-0209. Epub 2019 Sep 12.

oa_host_type: repository

unpaywall_oa_status: green

lead_sponsor: Cornerstone Pharmaceuticals

location_country:
Germany
France
Belgium
United States
Korea, Republic of
Israel

location_facility: Cleveland Clinic - Taussig Cancer Center

location_facility: Smilow Cancer Hospital at Yale-New Haven

location_facility: Severance Hospital - Yonsei Cancer Center

location_facility: The Chaim Sheba Medical Center - Sheba Cancer Research Center (SCRC)

location_facility: Northwestern Memorial Hospital - Arkes Family Pavilion

location_facility: University of Virginia Cancer Center - Emily Couric Clinical Cancer Center

location_facility: The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)

location_facility: Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH

location_facility: University of Pittsburgh-Hillman cancer ceter

location_facility: University of Cincinnati Cancer Institute

location_facility: New York University Langone Medical Center

location_facility: Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center-Henry-Joyce Cancer Clinic

location_facility: Seoul National University Bundang Hospital

location_facility: CHU Hopitaux de Bordeaux - Hôpital Saint-André

location_facility: University Hospitals - Seidman Cancer Center

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: University of Massachusetts Memorial Medical Center

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Gustave Roussy Cancer Campus Grand Paris (Institut de Cancerologie Gustave-Roussy)

location_facility: The University of Kansas Cancer Center - Clinical Research Center - Fairway Office Park

location_facility: Centre Hospitalier Départemental Vendée - Hôpital de la Roche-sur-Yon

location_facility: UNC Lineberger Comprehensive Cancer Center

location_facility: L'ICM, Institut régional du Cancer de Montpellier


acronym: PROMIS-II

lead_sponsor: Zambon SpA

summary: The primary objective of the trial was to investigate the effect of the use of inhaled colistimethate sodium (CMS), administered twice a day (b.i.d.) via a specific nebulizer for 12 months, compared to placebo in subjects with non-cystic fibrosis bronchiectasis (NCFB) chronically infected with P. aeruginosa on the annualised frequency of pulmonary exacerbations.

location_facility:
Zambon Investigative Site
ZambonInvestigative Site
Zambon Investgative Site
Zambon investigative Site
Zambon investigative site

title: Efficacy and Safety of 12 Months of Therapy With Inhaled Colistimethate Sodium in Subjects With Non-cystic Fibrosis Bronchiectasis Chronically Infected With P. Aeruginosa

primary_purpose: Prevention

location_country:
Germany
Italy
Poland
Portugal
New Zealand
Israel
Argentina
Australia
United States
Greece
Canada
France


acronym: A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis

lead_sponsor: Corbus Pharmaceuticals Inc.

summary:
This is a Phase 2 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of cystic fibrosis in patients 12 years of age or older. Approximately 415 subjects will be enrolled in this study at about 100 sites in North America, and Europe. The planned duration of treatment with study drug is 28 weeks.

Study drug will be lenabasum 20 mg BID, lenabasum 5 mg BID, and placebo in a 2:1:2 ratio.

sponsor_collaborators:
Corbus Pharmaceuticals Inc.
Cystic Fibrosis Foundation

location_facility: Diagnostic Children Hospital, Department of Pediatrics and Adolescent Medicine, Department of Pediatric Pulmonary, Allergology and Endocrinology

location_facility: Dartmouth-Hitchcock Medical Center (main location)

location_facility: Dartmouth-Hitchcock Manchester (satellite site)

location_facility: First St. Petersburg State Pavlov Medical University

location_facility: Institute for Child and Youth Health Care of Vojvodina

location_facility: Clinical for Pulmonary Diseases, Clinical Center of Serbia

location_facility: Institute for Mother and Child, Department of CF for Children's and Youth

location_facility: Bács-Kiskun County Hospital, Teaching Hospital of the University of Szeged

location_facility: Royal Brompton & Harefield NHS Foundation Trust

location_facility: The University of Texas Health Science Center at Tyler

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Azienda Ospedaliera Universitaria Verona

location_facility: Scientfic Research Institute of Pulmonology

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Oddzial Pediatrii z Pododdzialem Leczenia Mukowiscydozy

location_facility: Royal Papworth Hospital NHS Foundation Trust

location_facility: Wolfson Cystic Fibrosis Centre City Hospital Campus

location_facility: Cystic Fibrosis Centre Innsbruck Medical University of Innsbruck, Dept. for Child and Adolescent Health, University Clinic for Paediatrics, Cardiology, Pneumology, Allergology, Cystic Fibrosis

location_facility: Institute for Pulmonary Disease of Vojvodina

location_facility: Centre hospitalier de l'Université de Montréal (CHUM)

location_facility: Instytut Matki I Dziecka, Centrum Leczenia Mukowiscydozy - Oddzial Chorob Pluc

location_facility: University of Arkansas for Medical Sciences

location_facility: Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center

location_facility: Rutgers Robert Wood Johnson Medical School

location_facility: Pediatric Pulmonology, Törökbálint, Hungary

location_facility: Birmingham Women's and Children's NHS Foundation Trust

location_facility: University of Debrecen - Kenezy Gyula University Hospital

location_facility: National Koranyi Institute of Pulmonology, Department of Cystic Fibrosis

location_facility: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

location_facility: Instytut Gruzlicy I Chorob Pluc Oddzial Terenowy im Jana I Ireny Rudnikow

location_facility: Moritz Kaposi General Hospital, Mosdós, Department of Pediatric Pulmonary Rehabilitation

location_facility: Service de Pediatrie Medico-Chirurgicale et Genetique

location_facility: University Medicine Essen Ruhrlandklinik

location_facility: Milton S. Hershey Medical Center / Penn State College of Medicine

location_facility: Cardiff and Vale University Health Board

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: Centre de Recherche en Explorations Fonctionnelles (CREF)

location_facility: General Hospital of Thessaloniki Ippokratio

location_facility: Klinikum der Ludwig Maximilian Universität München

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Catholic Hospital Bochum - St. Josef-Hospital

location_facility: Centro Regionale Toscano di Riferimento per la Fibrosi Cistica

location_facility: University Hospital and UW Health Clinics

location_facility: Medial Center for Ambulatory Diagnosis and Treatment

location_facility: Service de Pneumologie, Allergologie, Mucoviscidose; Hôpital Femme-Mère-Enfant

location_facility: Unidad de Fibrosis Quistica y Transplante Pulmonar

location_facility: Children's faculty hospital with polyclinic Banska Bystrica

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis

location_country:
Germany
Poland
Czechia
Canada
Serbia
France
Portugal
Slovakia
Hungary
United States
Romania
Belgium
Italy
United Kingdom
Netherlands
Austria
Spain
Greece
Bulgaria
Russian Federation
Sweden