title: A Randomized, Open-label, Phase 3 Study of Carfilzomib Plus Dexamethasone vs. Bortezomib Plus Dexamethasone in Patients With Relapsed Multiple Myeloma

acronym: ENDEAVOR

summary: The primary objective of this study was to compare progression-free survival in patients with multiple myeloma who relapsed after 1 to 3 prior therapies treated with carfilzomib plus dexamethasone or bortezomib plus dexamethasone.

ReferenceCitation: Moreau P, Joshua D, Chng WJ, Palumbo A, Goldschmidt H, Hájek R, Facon T, Ludwig H, Pour L, Niesvizky R, Oriol A, Rosiñol L, Suvorov A, Gaidano G, Pika T, Weisel K, Goranova-Marinova V, Gillenwater HH, Mohamed N, Aggarwal S, Feng S, Dimopoulos MA. Impact of prior treatment on patients with relapsed multiple myeloma treated with carfilzomib and dexamethasone vs bortezomib and dexamethasone in the phase 3 ENDEAVOR study. Leukemia. 2017 Jan;31(1):115-122. doi: 10.1038/leu.2016.186. Epub 2016 Jul 4.

ReferenceCitation: Chng WJ, Goldschmidt H, Dimopoulos MA, Moreau P, Joshua D, Palumbo A, Facon T, Ludwig H, Pour L, Niesvizky R, Oriol A, Rosiñol L, Suvorov A, Gaidano G, Pika T, Weisel K, Goranova-Marinova V, Gillenwater HH, Mohamed N, Feng S, Aggarwal S, Hájek R. Carfilzomib-dexamethasone vs bortezomib-dexamethasone in relapsed or refractory multiple myeloma by cytogenetic risk in the phase 3 study ENDEAVOR. Leukemia. 2017 Jun;31(6):1368-1374. doi: 10.1038/leu.2016.390. Epub 2016 Dec 27.

ReferenceCitation: Dimopoulos MA, Goldschmidt H, Niesvizky R, Joshua D, Chng WJ, Oriol A, Orlowski RZ, Ludwig H, Facon T, Hajek R, Weisel K, Hungria V, Minuk L, Feng S, Zahlten-Kumeli A, Kimball AS, Moreau P. Carfilzomib or bortezomib in relapsed or refractory multiple myeloma (ENDEAVOR): an interim overall survival analysis of an open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Oct;18(10):1327-1337. doi: 10.1016/S1470-2045(17)30578-8. Epub 2017 Aug 23. Erratum in: Lancet Oncol. 2017 Oct;18(10):e562.

ReferenceCitation: Ludwig H, Dimopoulos MA, Moreau P, Chng WJ, Goldschmidt H, Hájek R, Facon T, Pour L, Niesvizky R, Oriol A, Rosiñol L, Suvorov A, Gaidano G, Pika T, Weisel K, Goranova-Marinova V, Palumbo A, Gillenwater HH, Mohamed N, Aggarwal S, Feng S, Joshua D. Carfilzomib and dexamethasone vs bortezomib and dexamethasone in patients with relapsed multiple myeloma: results of the phase 3 study ENDEAVOR (NCT01568866) according to age subgroup. Leuk Lymphoma. 2017 Oct;58(10):2501-2504. doi: 10.1080/10428194.2017.1298755. Epub 2017 Mar 17.

ReferenceCitation: Chari A, Stewart AK, Russell SD, Moreau P, Herrmann J, Banchs J, Hajek R, Groarke J, Lyon AR, Batty GN, Ro S, Huang M, Iskander KS, Lenihan D. Analysis of carfilzomib cardiovascular safety profile across relapsed and/or refractory multiple myeloma clinical trials. Blood Adv. 2018 Jul 10;2(13):1633-1644. doi: 10.1182/bloodadvances.2017015545. Review.

ReferenceCitation: Dimopoulos M, Siegel D, White DJ, Boccia R, Iskander KS, Yang Z, Kimball AS, Mezzi K, Ludwig H, Niesvizky R. Carfilzomib vs bortezomib in patients with multiple myeloma and renal failure: a subgroup analysis of ENDEAVOR. Blood. 2019 Jan 10;133(2):147-155. doi: 10.1182/blood-2018-06-860015. Epub 2018 Nov 26.

ReferenceCitation: Facon T, Niesvizky R, Mateos MV, Siegel D, Rosenbaum C, Bringhen S, Weisel K, Ho PJ, Ludwig H, Kumar S, Wang K, Obreja M, Yang Z, Klippel Z, Mezzi K, Goldrick A, Tekle C, Dimopoulos MA. Efficacy and safety of carfilzomib-based regimens in frail patients with relapsed and/or refractory multiple myeloma. Blood Adv. 2020 Nov 10;4(21):5449-5459. doi: 10.1182/bloodadvances.2020001965.

ReferenceCitation: Hari P, Mateos MV, Abonour R, Knop S, Bensinger W, Ludwig H, Song K, Hajek R, Moreau P, Siegel DS, Feng S, Obreja M, Aggarwal SK, Iskander K, Goldschmidt H. Efficacy and safety of carfilzomib regimens in multiple myeloma patients relapsing after autologous stem cell transplant: ASPIRE and ENDEAVOR outcomes. Leukemia. 2017 Dec;31(12):2630-2641. doi: 10.1038/leu.2017.122. Epub 2017 Apr 25.

ReferenceCitation: Leleu X, Martin TG, Einsele H, Lyons RM, Durie BGM, Iskander KS, Ailawadhi S. Role of Proteasome Inhibitors in Relapsed and/or Refractory Multiple Myeloma. Clin Lymphoma Myeloma Leuk. 2019 Jan;19(1):9-22. doi: 10.1016/j.clml.2018.08.016. Epub 2018 Sep 5. Review.

ReferenceCitation: Ludwig H, Moreau P, Dimopoulos MA, Mateos MV, Kaiser M, Hajek R, Feng S, Cocks K, Buchanan J, Weisel K. Health-related quality of life in the ENDEAVOR study: carfilzomib-dexamethasone vs bortezomib-dexamethasone in relapsed/refractory multiple myeloma. Blood Cancer J. 2019 Feb 22;9(3):23. doi: 10.1038/s41408-019-0181-0.

ReferenceCitation: Mateos MV, Goldschmidt H, San-Miguel J, Mikhael J, DeCosta L, Zhou L, Obreja M, Blaedel J, Szabo Z, Leleu X. Carfilzomib in relapsed or refractory multiple myeloma patients with early or late relapse following prior therapy: A subgroup analysis of the randomized phase 3 ASPIRE and ENDEAVOR trials. Hematol Oncol. 2018 Apr;36(2):463-470. doi: 10.1002/hon.2499. Epub 2018 Feb 15.

ReferenceCitation: Moreau P, Stewart KA, Dimopoulos M, Siegel D, Facon T, Berenson J, Raje N, Berdeja JG, Orlowski RZ, Yang H, Ma H, Klippel Z, Zahlten-Kumeli A, Mezzi K, Iskander K, Mateos MV. Once-weekly (70 mg/m2 ) vs twice-weekly (56 mg/m2 ) dosing of carfilzomib in patients with relapsed or refractory multiple myeloma: A post hoc analysis of the ENDEAVOR, A.R.R.O.W., and CHAMPION-1 trials. Cancer Med. 2020 May;9(9):2989-2996. doi: 10.1002/cam4.2945. Epub 2020 Feb 28.

ReferenceCitation: Dimopoulos MA, Moreau P, Iida S, Huang SY, Takezako N, Chng WJ, Zahlten-Kumeli A, Sersch MA, Li J, Huang M, Lee JH. Outcomes for Asian patients with multiple myeloma receiving once- or twice-weekly carfilzomib-based therapy: a subgroup analysis of the randomized phase 3 ENDEAVOR and A.R.R.O.W. Trials. Int J Hematol. 2019 Oct;110(4):466-473. doi: 10.1007/s12185-019-02704-z. Epub 2019 Aug 6.

ReferenceCitation: Goldschmidt H, Moreau P, Ludwig H, Niesvizky R, Chng WJ, Joshua D, Weisel K, Spencer A, Orlowski RZ, Feng S, Iskander KS, Dimopoulos MA. Carfilzomib-dexamethasone versus subcutaneous or intravenous bortezomib in relapsed or refractory multiple myeloma: secondary analysis of the phase 3 ENDEAVOR study. Leuk Lymphoma. 2018 Jun;59(6):1364-1374. doi: 10.1080/10428194.2017.1376743. Epub 2017 Sep 22.

ReferenceCitation: Jakubowiak AJ, Houisse I, Majer I, Benedict A, Campioni M, Panjabi S, Ailawadhi S. Cost-effectiveness of carfilzomib plus dexamethasone compared with bortezomib plus dexamethasone for patients with relapsed or refractory multiple myeloma in the United States. Expert Rev Hematol. 2017 Dec;10(12):1107-1119. doi: 10.1080/17474086.2017.1391088.

ReferenceCitation: Weisel K, Mateos MV, Gay F, Delforge M, Cook G, Szabo Z, Desgraz R, DeCosta L, Moreau P. Efficacy and safety profile of deep responders to carfilzomib-based therapy: a subgroup analysis from ASPIRE and ENDEAVOR. Leukemia. 2021 Jun;35(6):1732-1744. doi: 10.1038/s41375-020-01049-5. Epub 2020 Oct 16.

ReferenceCitation: Weisel K, Majer I, DeCosta L, Oriol A, Goldschmidt H, Ludwig H, Campioni M, Szabo Z, Dimopoulos M. Carfilzomib and dexamethasone versus eight cycles of bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma: an indirect comparison using data from the phase 3 ENDEAVOR and CASTOR trials. Leuk Lymphoma. 2020 Jan;61(1):37-46. doi: 10.1080/10428194.2019.1648806. Epub 2019 Oct 22.

ReferenceCitation: Orlowski RZ, Moreau P, Niesvizky R, Ludwig H, Oriol A, Chng WJ, Goldschmidt H, Yang Z, Kimball AS, Dimopoulos M. Carfilzomib-Dexamethasone Versus Bortezomib-Dexamethasone in Relapsed or Refractory Multiple Myeloma: Updated Overall Survival, Safety, and Subgroups. Clin Lymphoma Myeloma Leuk. 2019 Aug;19(8):522-530.e1. doi: 10.1016/j.clml.2019.04.018. Epub 2019 May 2.

ReferenceCitation: Majer IM, Castaigne JG, Palmer S, DeCosta L, Campioni M. Modeling Covariate-Adjusted Survival for Economic Evaluations in Oncology. Pharmacoeconomics. 2019 May;37(5):727-737. doi: 10.1007/s40273-018-0759-6.

ReferenceCitation: Rosenthal A, Luthi J, Belohlavek M, Kortüm KM, Mookadam F, Mayo A, Fonseca R, Bergsagel PL, Reeder CB, Mikhael JR, Stewart AK. Carfilzomib and the cardiorenal system in myeloma: an endothelial effect? Blood Cancer J. 2016 Jan 15;6:e384. doi: 10.1038/bcj.2015.112.

ReferenceCitation: Dimopoulos MA, Moreau P, Palumbo A, Joshua D, Pour L, Hájek R, Facon T, Ludwig H, Oriol A, Goldschmidt H, Rosiñol L, Straub J, Suvorov A, Araujo C, Rimashevskaya E, Pika T, Gaidano G, Weisel K, Goranova-Marinova V, Schwarer A, Minuk L, Masszi T, Karamanesht I, Offidani M, Hungria V, Spencer A, Orlowski RZ, Gillenwater HH, Mohamed N, Feng S, Chng WJ; ENDEAVOR Investigators. Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): a randomised, phase 3, open-label, multicentre study. Lancet Oncol. 2016 Jan;17(1):27-38. doi: 10.1016/S1470-2045(15)00464-7. Epub 2015 Dec 5.

lead_sponsor: Amgen

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Romania
Belgium
Japan
Czechia
Poland
Austria
Australia
Russian Federation
Israel
Singapore
Slovakia
Brazil
Canada
Hungary
Germany
Bulgaria
Taiwan
Greece
New Zealand
Thailand
Korea, Republic of
France

location_facility: National Institute of Cancer, Oncohematology Department

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: MI "Dnipropetrovsk City Multifield Clinical Hospital #4" of Dnipropetrovsk Regional Council", City Hematology Center

location_facility: Chang Gung Medical Foundation-LinKou Branch

location_facility: Khmelnytsky Regional Hospital, Department of Hematology

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

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

location_facility: Irmandade da Santa Casa de Misericórdia de São Paulo

location_facility: Haematology & Oncology Clinics of Australia

location_facility: Spitalul Clinic Judetean de Urgenta Brasov (Bumbea, Horia)

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich

location_facility: Specjalistyczny Szpital Miejski im. Mikolaja Kopernika

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: Municipal Institution of Health Protection "Clinical Hospital #8"

location_facility: The Chaim Sheba Medical Center at Tel Hashomer

location_facility: Universitätsmedizin der Johannes Gutenberg Universität

location_facility: Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro

location_facility: Lviv State Oncology Regional Treatment-Prophylactic Center, Department of Chemotherapy

location_facility: Social Insurance Kyoto Hospital of All Japan Federation of Social Insurance Associations

location_facility: Kobe City Medical Center General Hospital

location_facility: Policlinica de Diagnostic Rapid SA, Compartiment Medical Oncologie-Hematologie

location_facility: GUZ Samara Regional Clinical Hospital n.a. M.I. Kalinin

location_facility: Zamojski Szpital Niepubliczny Sp. z o.o.

location_facility: Multiprofile Hospital for Active Treatment, "Sveta Marina''

location_facility: First Saint Petersburg I.P. Pavlov State Medical University

location_facility: Krankenhaus der Elisabethinen Linz, I Interne Abteilung

location_facility: City Clinical Hospital n.a. S. P. Botkin

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou

location_facility: FGU Russian Scientific Research Institute of Hematology and Transfusiology

location_facility: Queen Elizabeth II Health Science Centre

location_facility: National Hospital Organization Nishigunma National Hospital

location_facility: Hospital Universitário Clementino Fraga Filho da Universidade Federal do Rio de Janeiro

location_facility: Hospital Universitari i Politecnic La Fé de Valencia

location_facility: University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD

location_facility: Hospital Clínico Universitario de Salamanca

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Haematology and Oncology Clinics of Australia at Chermside

location_facility: Università Tor Vergata Ospedale Sant Eugenio

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Universitätsklinikum Carl Gustav Carus, Med. Klinik und Poliklinik I

location_facility: Military Medical Academy Hospital for Active Treatment

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: The Ottawa Hospital Regional Cancer Centre

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Azienda Ospedaliera Universitaria Maggiore della Carità

location_facility: Instituto Centros Oncológicos Integrados de Educação e Pesquisa

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Azienda Ospedaliero-Univesitaria San Luigi Gonzaga

location_facility: Wake Forest University Health Sciences, Section on Hematology and Oncology

location_facility: Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza

location_facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino

location_facility: Seoul National University Bundang Hospital

location_facility: Medizinische Klinik der Universität Würzburg

location_facility: Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto

location_facility: Azienda Ospedaliera Pisana Ospedale Santa Chiara

location_facility: Haematology and Oncology Clinics of Australia at Wesley

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Egyesített Szent István és Szent László Kórház-Rendelointézet

location_facility: Institute of Urgent and Reparative Surgury of Ukraine Academy of Medical Sciences

location_facility: The Cancer Institute Hospital Of Japanese Foundation For Cancer Research

location_facility: National Hospital Organization Disaster Medical Center

location_facility: Non-state Healthcare Institution "N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway

location_facility: Hopital Hotel-Dieu - Service d'Hematologie

location_facility: Azienda Ospedaliera Universitaria Senese - Policlinico S. Maria alle Scotte


type: Other Identifier

type: Registry Identifier

type: EudraCT Number

title: A Phase 1/2 Open-label Study to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of Modakafusp Alfa (TAK-573) as a Single Agent in Patients With Relapsed Refractory Multiple Myeloma

summary:
The main aims of this 3-part study are as follows:

Part 1: To determine any side effects from modakafusp alfa single treatment and how often they occur. The dose of modakafusp alfa will be increased a little at a time until the highest dose that does not cause harmful side effects is found.

Part 2: To assess clinical activity of one or more dosing schedules of modakafusp alfa alone in participants with relapsed/refractory multiple myeloma. Dexamethasone standard dose will be administered with one or more selected dose of modakafusp alfa in selected group of participants.

Part 3: To find the optimal dose with the more favorable risk-benefit profile of modakafusp alfa.

Participants will receive modakafusp alfa at one of two doses which will be given through a vein.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Takeda

location_country:
Taiwan
Spain
Greece
Ireland
Italy
United Kingdom
Canada
Korea, Republic of
United States
France
China
Israel
Norway
Japan
Germany
Puerto Rico
Turkey
Czechia

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Chonnam National University Hwasun Hospital

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

location_facility: Los Angeles Cancer Network - Glendale Adventist Medical Center

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

location_facility: British Columbia Cancer Agency Vancouver Centre

location_facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant'Orsola-Malpighi

location_facility: Sir Mortimer B. Davis Jewish General Hospital

location_facility: Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele

location_facility: The Christie - The Christie NHS Foundation Trust

location_facility: Institut de cancerologie Strasbourg Europe

location_facility: Univerzita Karlova - 1. Lekarska Fakulta

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: University Hospital - Kyoto Preferctural University of Medicine

location_facility: University Regional General Hospital of Patras

location_facility: Winship Cancer Institute of Emory University

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: USOR - Comprehensive Cancer Centers of Nevada - Central Valley

location_facility: Genesis Care Windsor - Genesis Care UK Ltd.

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: The First Affiliated Hospital of Soochow University - Suzhou First People's Hospital

location_facility: Northwestern Medicine - Northwestern Medical Group

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire de Toulouse Hopital Purpan

location_facility: Department of Medicine (DIMED) Hematology and Clinical Immunology

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Baptist Cancer Center - Memphis - Walnut Grove

location_facility: Centre Hospitalier Universitaire Nantes - Hotel Dieu

location_facility: University College London Hospitals NHS Foundation Trust

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


status: Active, not recruiting

title: A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Crohn's Disease

lead_sponsor: AbbVie

source: euctr

design_allocation: Randomized

ReferenceType: derived

ReferenceCitation: Ferrante M, Panaccione R, Baert F, Bossuyt P, Colombel JF, Danese S, Dubinsky M, Feagan BG, Hisamatsu T, Lim A, Lindsay JO, Loftus EV Jr, Panés J, Peyrin-Biroulet L, Ran Z, Rubin DT, Sandborn WJ, Schreiber S, Neimark E, Song A, Kligys K, Pang Y, Pivorunas V, Berg S, Duan WR, Huang B, Kalabic J, Liao X, Robinson A, Wallace K, D'Haens G. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial. Lancet. 2022 May 28;399(10340):2031-2046. doi: 10.1016/S0140-6736(22)00466-4.

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.

enrollment_type: Actual

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Belgium
Japan
Romania
South Africa
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Mexico
Norway
Malaysia
Singapore
Sweden
Slovakia
Egypt
Bosnia and Herzegovina
Canada
Switzerland
China
Germany
Bulgaria
Denmark
Taiwan
Belarus
Greece
Ireland
Estonia
Latvia
New Zealand
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: Yeungnam University Medical Center /ID# 158691

location_facility: Vilnius University Hospital Santaros Klinikos /ID# 162514

location_facility: Nemocnice Pardubickeho kraje, a.s. /ID# 163226

location_facility: Gastroenterologische Gemeinschaftspraxis Minden /ID# 162029

location_facility: Taichung Veterans General Hospital /ID# 160140

location_facility: West China Hospital, Sichuan University /ID# 210890

location_facility: Tongji Hospital Tongji Medical College of HUST /ID# 210858

location_facility: Fujita Health University Hospital /ID# 163234

location_facility: Fakultni Thomayerova nemocnice /ID# 162941

location_facility: CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 216474

location_facility: Universal Axon Clinical Research /ID# 165428

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 163708

location_facility: Allen Whey Khye Lim Professional Corporation /ID# 169763

location_facility: Renmin Hospital of Wuhan University /ID# 214874

location_facility: A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 155645

location_facility: Revival Research Institute, Inc /ID# 210985

location_facility: Adult Gastroenterology Associates - Gen 1 Research /ID# 208864

location_facility: UMHAT Tsaritsa Joanna - ISUL /ID# 211242

location_facility: Private Practice Dr MN Rajabally /ID# 163112

location_facility: The Jikei University Hospital /ID# 163209

location_facility: Hospital Clinic de Barcelona /ID# 157552

location_facility: QEII - Health Sciences Centre /ID# 157088

location_facility: The Chaim Sheba Medical Center /ID# 171069

location_facility: Hospital Clinico Universitario Lozano Blesa /ID# 212525

location_facility: West Tallinn Central Hospital /ID# 157075

location_facility: Hospital General Universitario Gregorio Maranon /ID# 161145

location_facility: Duplicate_AOU Ospendali Riuniti di Ancona /ID# 162436

location_facility: Omega Research Maitland, LLC /ID# 171082

location_facility: City Clinical Hospital No. 31 /ID# 208872

location_facility: Chu de Nice-Hopital L'Archet Ii /Id# 162557

location_facility: Hometown Urgent Care and Resea /ID# 170464

location_facility: Gastro Health & Nutrition - Victoria /ID# 164290

location_facility: Tokai University Hachioji Hospital /ID# 160098

location_facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 170914

location_facility: Zagazig University Hospitals /ID# 164539

location_facility: Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 201363

location_facility: ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 155639

location_facility: China Medical University Hospital /ID# 160141

location_facility: Royal Devon and Exeter NHS Trust Hospital /ID# 157544

location_facility: Oxford University Hospitals NHS Foundation Trust /ID# 158036

location_facility: Houma Digestive Health Special /ID# 158264

location_facility: Scott Shulman Medicine Professional Corporation /ID# 165906

location_facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 157423

location_facility: Baylor College of Medicine - Baylor Medical Center /ID# 158203

location_facility: Akershus universitetssykehus /ID# 169379

location_facility: Universitaetsklinikum St. Poelten /ID# 166424

location_facility: Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 159406

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 162583

location_facility: Osaka Metropolitan University Hospital /ID# 160117

location_facility: Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 157187

location_facility: Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 160673

location_facility: Royal Victoria Hospital / McGill University Health Centre /ID# 157085

location_facility: Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 213580

location_facility: Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz /ID# 167751

location_facility: National Hepatology and Tropical Medicine Research Institute /ID# 157874

location_facility: Karolinska University Hospital Solna /ID# 212025

location_facility: University Children's Hospital 'Tirsova' /ID# 211482

location_facility: Percuro Clinical Research, Ltd /ID# 161631

location_facility: Children's Hospital of Pittsburgh of UPMC /ID# 212544

location_facility: Yamanashi Prefectural Central Hospital /ID# 160094

location_facility: Kyiv Municipal Clinical Hospital #18 /ID# 162531

location_facility: Sjællands Universitetshospital /ID# 155532

location_facility: Ulyanovsk Regional Clinical Hospital /ID# 200964

location_facility: Tver Regional Clinical Hospital /ID# 206858

location_facility: Hospital Guillermo Grant Benavente de Concepción /ID# 210760

location_facility: Medical University of South Carolina /ID# 212858

location_facility: Gokeikai Ofuna Chuo Hospital /ID# 171066

location_facility: Tyler Research Institute, LLC /ID# 166797

location_facility: Digestive Disease Center Gastro /ID# 163107

location_facility: Hospital Provincial del Centenario /ID# 170886

location_facility: Vestre viken - Baerum Sykehus /ID# 212996

location_facility: Northern Care Alliance NHS Group /ID# 207766

location_facility: Regional Clinical Hospital #1 /ID# 200973

location_facility: Clinical Associates in Research Therapeutics of America, LLC /ID# 161323

location_facility: Groupe Sante CHC - Clinique du MontLegia /ID# 157404

location_facility: Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 212799

location_facility: London Health Sciences Center /ID# 157161

location_facility: Nemocnice Horovice - NH Hospital a.s /ID# 211077

location_facility: Hospital Britanico de Buenos Aires /ID# 168077

location_facility: Investigacion Biomedica para el Desarrollo de Farmacos, S.A. de C.V. /ID# 170734

location_facility: The Jikei University Kashiwa Hospital /ID# 200030

location_facility: Servicio de Salud Occidente Hospital San Juan de Dios /ID# 171122

location_facility: Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 154873

location_facility: Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 210705

location_facility: Intercity Advanced Gastroentertology Center /ID# 215205

location_facility: Hospital Universitario y Politecnico La Fe /ID# 157556

location_facility: The First Affiliated Hospital of Nanchang University /ID# 211036

location_facility: Cleveland Clinic Main Campus /ID# 209226

location_facility: Toronto Digestive Disease Asso /ID# 157158

location_facility: Sylvester Comprehensive Cancer Center /ID# 155007

location_facility: Clinical Research Center, Faculty of Medicine, Cairo university /ID# 157175

location_facility: Wojewodzki Szpital Specjalistyczny /ID# 212474

location_facility: Leeds Teaching Hospitals NHS Trust /ID# 157550

location_facility: Tokyo Medical And Dental University Hospital /ID# 160095

location_facility: The Edith Wolfson Medical Center /ID# 217331

location_facility: South Lake Pain Institute, Inc /ID# 162808

location_facility: Nagoya City University Hospital /ID# 160100

location_facility: Yamagata University Hospital /ID# 200159

location_facility: United Medical Doctors - Murrieta /ID# 158300

location_facility: 1 Wojskowy Szpital Kliniczny Z Poliklinika /Id# 210940

location_facility: University General Hospital of Ioannina /ID# 157420

location_facility: CHU Bordeaux - Hopital Haut Leveque /ID# 162558

location_facility: University Clinical Center Serbia /ID# 157047

location_facility: Yonsei University Health System Severance Hospital /ID# 158689

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie /ID# 210941

location_facility: Virginia Mason Medical Center /ID# 155556

location_facility: MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 154832

location_facility: Hayang University GuriHospital /ID# 158690

location_facility: Western Connecticut Medical Group /ID# 165879

location_facility: Louisana Research Center, LLC /ID# 162237

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 155641

location_facility: Clinical Research of West Florida, Inc /ID# 205865

location_facility: MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 159350

location_facility: Rocky Mountain Pediatric Gastroenterology /ID# 207170

location_facility: Internal Medicine Department, Faculty of Medicine, AinShams University /ID# 157506

location_facility: Wakayama Medical University Hospital /ID# 202561

location_facility: Universitaetsklinikum Magdeburg /ID# 211843

location_facility: Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 211974

location_facility: Plains Clinical Research Center, LLC /ID# 169718

location_facility: University of California, San Francisco /ID# 157127

location_facility: Universitaetsklinikum Freiburg /ID# 162030

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 159349

location_facility: Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 155530

location_facility: Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 157553

location_facility: Hospital Universitario Puerta de Hierro, Majadahonda /ID# 157573

location_facility: Yokohama City University Medical Center /ID# 163907

location_facility: NYU Langone Long Island Clinical Research Associates /ID# 154829

location_facility: Cabinet Particular Policlinic Algomed /ID# 170900

location_facility: Centro Hospitalar de Entre Douro e Vouga /ID# 160672

location_facility: Clinical Hosp Center Zvezdara /ID# 157052

location_facility: Universitatsklinikum Mannheim /ID# 162031

location_facility: Stadtisches Klinikum Braunschweig /ID# 163680

location_facility: Advanced Research Institute, Inc /ID# 161966

location_facility: The Catholic University of Korea, ST. Vincent's Hospital /ID# 158693

location_facility: Icahn School of Medicine at Mount Sinai - The Mount Sinai Medical Center /ID# 165612

location_facility: Hospital Privado Univesitario /ID# 168076

location_facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 210625

location_facility: Guangdong Provincial People's Hospital /ID# 212949

location_facility: Brandon Premier Health Care, PA/Gulf Coast Research Group, LLC /ID# 162262

location_facility: Atrium Health Carolinas Medical Center /ID# 158428

location_facility: Hepato-Gastroenterologie HK, s.r.o. /ID# 163225

location_facility: Azienda Ospedaliera San Camillo Forlanini /ID# 155644

location_facility: Asahikawa Medical University Hospital /ID# 162848

location_facility: Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 160713

location_facility: Klinicka bolnica Dubrava Zagreb /ID# 157560

location_facility: CHU Amiens-Picardie Site Sud /ID# 165058

location_facility: Cambridge University Hospitals NHS Foundation Trust /ID# 158034

location_facility: St Vincent's University Hospital /ID# 157540

location_facility: Duplicate_Rambam Medical Center /ID# 171067

location_facility: Hamilton Health Sciences - McMaster University Medical Centre /ID# 157184

location_facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212220

location_facility: Hospital Universitario de Bellvitge /ID# 208207

location_facility: Medical Center of LLC Medbud-Clinic /ID# 216998

location_facility: National Taiwan University Hospital /ID# 162190

location_facility: Great Lakes Medical Research, LLC /ID# 201770

location_facility: Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego w Lodzi /ID# 212477

location_facility: Centex Studies, Inc. - Houston /ID# 201219

location_facility: South Florida Research Ph I-IV, Inc. /ID# 161832

location_facility: CHRU Nancy - Hopitaux de Brabois /ID# 162561

location_facility: Phoenix VA Health Care System /ID# 162264

location_facility: Medizinische Universitaet Wien /ID# 158141

location_facility: Digestive Disease Specialists /ID# 170775

location_facility: Hadassah Medical Center-Hebrew University /ID# 165914

location_facility: Hyogo Medical University Hospital /ID# 160107

location_facility: Velocity Clinical Research - Salt Lake City /ID# 161778

location_facility: TX Clinical Research Institute /ID# 159404

location_facility: KL Ling Gastroenterology and Liver Clinic /ID# 205741

location_facility: Medicinkliniken, Gastroenheten /ID# 163744

location_facility: Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 211306

location_facility: Guys and St Thomas NHS Foundation Trust /ID# 157546

location_facility: The Second Hospital of Hebei Medical University /ID# 212738

location_facility: Lviv Railway Clinical Hospital of branch Healthcare Centers of Public Joint Stoc /ID# 165658

location_facility: Gastroenterology Associates, P.A. of Greenville /ID# 154904

location_facility: Inselspital, Universitätsspital Bern /ID# 163535

location_facility: Southern Star Research Institute, LLC /ID# 168773

location_facility: Krankenhaus der Barmherzigen Brueder Wien /ID# 212060

location_facility: North Estonia Medical Centre /ID# 164326

location_facility: Centre Médico Chirurgical Ambroise Paré Hartmann /ID# 249858

location_facility: Helse More og Romsdal HF, Alesund sjukehus /ID# 212810

location_facility: Aichi Medical University Hospital /ID# 160097

location_facility: Duplicate_Centrul Medical Tuculanu SRL /ID# 170903

location_facility: Soroka University Medical Center /ID# 157794

location_facility: Fondazione PTV Policlinico Tor Vergata /ID# 158022

location_facility: Cedars-Sinai Medical Center-West Hollywood /ID# 163839

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 162559

location_facility: Sahlgrenska University Hospital /ID# 163792

location_facility: GIRI Gastrointestinal Research Institute /ID# 157096

location_facility: Hospital Universitario San Vic /ID# 171486

location_facility: Calderdale and Huddersfield NHS Foundation Trust /ID# 209570

location_facility: Tzaneio general hospital of Piraeus /ID# 206443

location_facility: UMHAT Dr Georgi Stranski EAD /ID# 203976

location_facility: CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 159056

location_facility: Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 160692

location_facility: Medizinische Hochschule Hannover /ID# 162032

location_facility: The University of Chicago Medical Center /ID# 157124

location_facility: Yokkaichi Hazu Medical Center /ID# 163764

location_facility: University Multiprofile Hospit /ID# 165700

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 210840

location_facility: CHA University Bundang Medical Center /ID# 158698

location_facility: Hull University Teaching Hospitals NHS Trust /ID# 158761

location_facility: Ospedale Policlinico San Martino /ID# 162439

location_facility: Kitasato University Hospital /ID# 171065

location_facility: East Tennessee Research Institute /ID# 168739

location_facility: Universitatsklinikum Munster /ID# 159344

location_facility: University Hospitals Birmingham NHS Foundation Trust /ID# 157545

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclaw /ID# 212601

location_facility: Clinical Center University of Sarajevo /ID# 165139

location_facility: Clin Hosp Ctr Bezanijska Kosa /ID# 157050

location_facility: Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211884

location_facility: Texas Digestive Disease Consultants /ID# 209946

location_facility: Alliance Biomedical Ural Group /ID# 200972

location_facility: Tianjin Medical University General Hospital /ID# 210926

location_facility: Vanderbilt University Medical Center /ID# 157121

location_facility: Hiroshima University Hospital /ID# 160109

location_facility: Nature Coast Clinical Research - Inverness /ID# 159408

location_facility: Klinicki bolnicki centar Split /ID# 157562

location_facility: Universitair Ziekenhuis Leuven /ID# 157407

location_facility: Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 161313

location_facility: Hospital Universitario La Paz /ID# 159235

location_facility: Texas Digestive Disease Consultants /ID# 209797

location_facility: Baylor Scott & White Center for Diagnostic Medicine /ID# 204131

location_facility: Universitaetsklinikum Regensburg /ID# 163813

location_facility: Northwell Health Division of Gastroenterology at Great Neck /ID# 168738

location_facility: H-T. Centrum Medyczne - Endoterapia /ID# 212475

location_facility: Kitasato University Kitasato Institute Hospital /ID# 160105

location_facility: Hospital Garcia de Orta, EPE /ID# 160745

location_facility: Hunter Holmes McGuire VA Medical Center /ID# 159988

location_facility: Pauls Stradins Clinical University Hospital /ID# 159612

location_facility: IRCCS Ospedale Sacro Cuore Don Calabria /ID# 161299

location_facility: Inje University Haeundae Hospital /ID# 202518

location_facility: Universitaetsklinikum Erlangen /ID# 159343

location_facility: Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 164540

location_facility: Praxiszentrum fuer Gastroenterologie /ID# 211966

location_facility: DiGiovanna Institute for Medical Education & Research /ID# 171126

location_facility: Medizinische Universitaet Graz /ID# 158140

location_facility: Shiga University of Medical Science Hospital /ID# 164025

location_facility: Ashford and St Peter's Hospitals NHS Foundation Trust /ID# 207936

location_facility: Cotton-O'Neil Clinical Res Ctr /ID# 154722

location_facility: Gastrointestinal Biosciences Clinical Trials, LLC /ID# 162657

location_facility: Duplicate_Perm state medical university n.a. E.A. Vagner /ID# 207439

location_facility: Unidad de Atencion Medica e Investigacion en Salud /ID# 170732

location_facility: National Cheng Kung University Hospital /ID# 160142

location_facility: Theageneio Anticancer Hospital /ID# 163897

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 157408

location_facility: Kanazawa University Hospital /ID# 202258

location_facility: Yokohama Municipal Citizen's Hospital /ID# 207161

location_facility: Southern California Res. Ctr. /ID# 211991

location_facility: A.O. Per L'Emergenza Cannizzaro /ID# 161300

location_facility: Hospital Universitario Miguel Servet /ID# 157557

location_facility: Nishinomiya Municipal Central Hospital /ID# 210103

location_facility: Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 159237

location_facility: Duplicate_Wellington Hospital (Capital and Coast District Health Board) /ID# 167225

location_facility: CHU Grenoble - Hopital Michallon /ID# 212834

location_facility: Pusan National University Hospital /ID# 158695

location_facility: Health Pharma Professional Research S.A de C.V /ID# 170730

location_facility: Sahlgrenska University Hospital /ID# 163797

location_facility: The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 213554

location_facility: Communal Noncommercial Institution Consultative and Diagnostic Center of Desnian /ID# 165659

location_facility: Sapporo Medical University Hospital /ID# 163056

location_facility: Gomel Regional Clinical Hospital /ID# 205112

location_facility: Hospital Clinico Universitario de Valencia /ID# 209700

location_facility: Taipei Veterans General Hosp /ID# 212712

location_facility: Municipal Nonprofit Enterprise Kherson city clinical hospital n.a. Y.Y. Karabel /ID# 212399

location_facility: Rapid City Medical Center - GI Research /ID# 163838

location_facility: University of Kentucky Chandler Medical Center /ID# 157120

location_facility: CHU UCL Namur - site Godinne /ID# 157412

location_facility: Second Multiprofile Hospital f /ID# 165702

location_facility: The second Affiliated hospital of Zhejiang University school of Medicine /ID# 210724

location_facility: Communal Enterprise Volyn Regional Clinical hospital of the Volyn Regional Coun /ID# 206789

location_facility: Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 162438

location_facility: NHS Greater Glasgow and Clyde /ID# 202568

location_facility: National University Hospital /ID# 160667

location_facility: Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 200970

location_facility: Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 212028

location_facility: Gastroenterology Associates LLC - Jefferson Hwy /ID# 161963

location_facility: Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 160737

location_facility: Hospital Universitario Basurto /ID# 205190

location_facility: Agaplesion Markus Krankenhaus /ID# 159345

location_facility: Columbia Univ Medical Center /ID# 161899

location_facility: Duplicate_Institut klinicke a experimentalni mediciny (IKEM) /ID# 165465

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 156468

location_facility: General Hospital of Nikaia-Piraeus "Agios Panteleimon"- general hospital dytikis /ID# 157424

location_facility: West Virginia University Hospitals /ID# 167941

location_facility: Clinical Research of West Florida, Inc /ID# 208125

location_facility: Hospital Universitario de Salamanca /ID# 157558

location_facility: Toho University Sakura Medical Center /ID# 160099

location_facility: Tokyo Women's Medical University Hospital /ID# 205974

location_facility: Centro Hosp de Tondela-Viseu /ID# 160699

location_facility: CHU Montpellier - Hôpital Saint Eloi /ID# 215147

location_facility: Kyiv Railway Clinical Hosp No.2 /ID# 217366

location_facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 166912

location_facility: Barnsley Hospital NHS Foundation Trust /ID# 202773

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 211039

location_facility: National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 204808

location_facility: Centro Hospitalar Universitário do Algarve, EPE - Hospital de Portimão /ID# 167752

location_facility: Gastroenterology Group Naples /ID# 165204

location_facility: Instituto de Coloproctologia /ID# 158743

location_facility: King's College Hospital NHS Foundation Trust /ID# 158760

location_facility: University of Alberta - Zeidler Ledcor Centre /ID# 157099

location_facility: Duplicate_Newport Huntington Medical Group /ID# 213035

location_facility: The Second Xiangya Hospital of Central South University /ID# 211700

location_facility: Tel Aviv Sourasky Medical Center /ID# 157792

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 163582

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 155643

location_facility: ASST Rhodense/Presidio Ospedaliero di Rho /ID# 212227

location_facility: University Clinical Centre of the Republic of Srpska /ID# 164513

location_facility: Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 210528

location_facility: Clinical Neuroscience Solutions - Memphis /ID# 164180

location_facility: Transcarpathian Regional Clinical Hospital n.a. Andriy Novak /ID# 167960

location_facility: Elisabeth Tweesteden Ziekenhuis /ID# 163632

location_facility: Medizinisches Versorgunszentrum Dachau /ID# 211555

location_facility: NorthShore University HealthSystem /ID# 158265

location_facility: Kuzbass Regional Clinical Hospital /ID# 200962

location_facility: Peak Gastroenterology Associates, PC /ID# 165843

location_facility: The Chaim Sheba Medical Center /ID# 157793

location_facility: Kharkiv City Clinical Hospital No.2 n.a. Prof. O.O. Shalimov /ID# 165657

location_facility: National Hospital Organization Mito Medical Center /ID# 160092

location_facility: Klinicki bolnicki centar Sestre milosrdnice /ID# 157728

location_facility: Complejo Asistencial Dr. Sotero del Rio /ID# 169384

location_facility: Evangelisches Krankenhaus Kalk /ID# 212726

location_facility: Clinic of Scientific Research Institute of Invalid Rehabilitation /ID# 212000

location_facility: Duplicate_St. Petersburg State Pediatric Medical University /ID# 211978

location_facility: Digestive Disease Associates, LTD /ID# 208297

location_facility: Tsujinaka Hospital Kashiwanoha /ID# 213848

location_facility: Klinicki bolnicki centar Zagreb /ID# 157561

location_facility: Gastroenterology Associates of Central Georgia, LLC /ID# 154850

location_facility: Centrum Medyczne LukaMed Joanna Luka-Wendrowska /ID# 212478

location_facility: Clin Res Inst of Michigan, LLC /ID# 169179

location_facility: Vitebsk Regional Advanced Clin /ID# 206778

location_facility: Jinhua Municipal Central Hospital /ID# 215628

location_facility: Universitaetsklinikum Frankfurt /ID# 212979

location_facility: Praxis fuer Gastroenterologie /ID# 166150

location_facility: University of Nebraska Medical Center /ID# 210058

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 160096

location_facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212894

location_facility: University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 157126

location_facility: East Tallinn Central Hospital /ID# 157074

location_facility: Hospital Universitario Virgen Macarena /ID# 159967

location_facility: Duplicate_Fondazione IRCCS Policlinico S. Matteo /ID# 212031

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 160693

location_facility: Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 213447

location_facility: Duplicate_Azienda Ospedaliera Univ. Meyer /ID# 167992

location_facility: The Sixth Affiliated Hosp Sun /ID# 210784

location_facility: Odense Universitets Hospital /ID# 155531

location_facility: Grodno city clinical hospital #2 /ID# 205113

location_facility: University Clinical Center Kragujevac /ID# 157049

location_facility: Hamamatsu University Hospital /ID# 205690

location_facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 162562

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 157422

location_facility: Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 155640

summary:
The study consists of 4 sub-studies, as follows:

Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in participants with moderately to severely active Crohn's disease (CD) who responded to intravenous risankizumab induction treatment in Study M16-006 or Study M15-991;
Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in participants who responded to induction treatment in Study M16-006 or Study M15-991;
Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of risankizumab in participants who completed Sub-study 1, Sub-study 2, another AbbVie risankizumab Crohn's disease study, or participants who responded to induction treatment in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab;
Sub-study 4 (Open-label On Body Injector (OBI) administration and long-term extension study) to evaluate patient-reported outcomes, efficacy, safety, tolerability, and pharmacokinetics of risankizumab administered via OBI in participants who are receiving maintenance treatment with risankizumab.


status: Completed

title: A Phase 2, Open-Label Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2)

study_completion_date_type: Actual

lead_sponsor: Clovis Oncology, Inc.

ReferenceCitation: Green ML, Ma SC, Goble S, Giordano H, Maloney L, Simmons AD, Beltman J, Harding TC, Xiao JJ. Population pharmacokinetics of rucaparib in patients with advanced ovarian cancer or other solid tumors. Cancer Chemother Pharmacol. 2022 May;89(5):671-682. doi: 10.1007/s00280-022-04413-7. Epub 2022 Apr 10.

ReferenceCitation: Tattersall A, Ryan N, Wiggans AJ, Rogozińska E, Morrison J. Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer. Cochrane Database Syst Rev. 2022 Feb 16;2:CD007929. doi: 10.1002/14651858.CD007929.pub4. Review.

ReferenceCitation: Swisher EM, Kwan TT, Oza AM, Tinker AV, Ray-Coquard I, Oaknin A, Coleman RL, Aghajanian C, Konecny GE, O'Malley DM, Leary A, Provencher D, Welch S, Chen LM, Wahner Hendrickson AE, Ma L, Ghatage P, Kristeleit RS, Dorigo O, Musafer A, Kaufmann SH, Elvin JA, Lin DI, Chambers SK, Dominy E, Vo LT, Goble S, Maloney L, Giordano H, Harding T, Dobrovic A, Scott CL, Lin KK, McNeish IA. Molecular and clinical determinants of response and resistance to rucaparib for recurrent ovarian cancer treatment in ARIEL2 (Parts 1 and 2). Nat Commun. 2021 May 3;12(1):2487. doi: 10.1038/s41467-021-22582-6.

ReferenceCitation: Kristeleit RS, Oaknin A, Ray-Coquard I, Leary A, Balmaña J, Drew Y, Oza AM, Shapira-Frommer R, Domchek SM, Cameron T, Maloney L, Goble S, Lorusso D, Ledermann JA, McNeish IA. Antitumor activity of the poly(ADP-ribose) polymerase inhibitor rucaparib as monotherapy in patients with platinum-sensitive, relapsed, BRCA-mutated, high-grade ovarian cancer, and an update on safety. Int J Gynecol Cancer. 2019 Nov;29(9):1396-1404. doi: 10.1136/ijgc-2019-000623.

ReferenceCitation: Swisher EM, Lin KK, Oza AM, Scott CL, Giordano H, Sun J, Konecny GE, Coleman RL, Tinker AV, O'Malley DM, Kristeleit RS, Ma L, Bell-McGuinn KM, Brenton JD, Cragun JM, Oaknin A, Ray-Coquard I, Harrell MI, Mann E, Kaufmann SH, Floquet A, Leary A, Harding TC, Goble S, Maloney L, Isaacson J, Allen AR, Rolfe L, Yelensky R, Raponi M, McNeish IA. Rucaparib in relapsed, platinum-sensitive high-grade ovarian carcinoma (ARIEL2 Part 1): an international, multicentre, open-label, phase 2 trial. Lancet Oncol. 2017 Jan;18(1):75-87. doi: 10.1016/S1470-2045(16)30559-9. Epub 2016 Nov 29.

location_country:
Spain
United Kingdom
Australia
Canada
United States
France

location_facility: Washington University School of Medicine

location_facility: Crown Princess Mary Cancer Centre (Westmead Hospital)

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: University of Cincinnati Physicians Company

location_facility: New York University Langone Medical Center

location_facility: Flinders Cancer Clinic - Flinders Medical Centre (FMC)

location_facility: The Ohio State University Wexner Medical Center

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: University of Miami Hospital & Clinics Sylvester Comprehensive Cancer Center

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Imperial College Healthcare NHS Trust - Hammersmith Hospital

location_facility: Centre Hospitalier de L'Universite de Montreal

location_facility: Vancouver Cancer Centre, British Columbia Cancer Agency (BCCA)

location_facility: Sir Bobby Robson Cancer Trials Research Centre, Northern Centre for Cancer Care

summary: The purpose of this study is to determine which patients with ovarian, fallopian tube, and primary peritoneal cancer will best respond to treatment with rucaparib.

status_simplified: Completed


intervention_type: Radiation

title: A Randomized, Placebo Controlled Phase 3 Study of ABT-414 With Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance1)

ReferenceCitation: Lassman AB, van den Bent MJ, Gan HK, Reardon DA, Kumthekar P, Butowski N, Lwin Z, Mikkelsen T, Nabors LB, Papadopoulos KP, Penas-Prado M, Simes J, Wheeler H, Walbert T, Scott AM, Gomez E, Lee HJ, Roberts-Rapp L, Xiong H, Ansell PJ, Bain E, Holen KD, Maag D, Merrell R. Safety and efficacy of depatuxizumab mafodotin + temozolomide in patients with EGFR-amplified, recurrent glioblastoma: results from an international phase I multicenter trial. Neuro Oncol. 2019 Jan 1;21(1):106-114. doi: 10.1093/neuonc/noy091.

ReferenceCitation: Gan HK, Reardon DA, Lassman AB, Merrell R, van den Bent M, Butowski N, Lwin Z, Wheeler H, Fichtel L, Scott AM, Gomez EJ, Fischer J, Mandich H, Xiong H, Lee HJ, Munasinghe WP, Roberts-Rapp LA, Ansell PJ, Holen KD, Kumthekar P. Safety, pharmacokinetics, and antitumor response of depatuxizumab mafodotin as monotherapy or in combination with temozolomide in patients with glioblastoma. Neuro Oncol. 2018 May 18;20(6):838-847. doi: 10.1093/neuonc/nox202.

ReferenceCitation: Reardon DA, Lassman AB, van den Bent M, Kumthekar P, Merrell R, Scott AM, Fichtel L, Sulman EP, Gomez E, Fischer J, Lee HJ, Munasinghe W, Xiong H, Mandich H, Roberts-Rapp L, Ansell P, Holen KD, Gan HK. Efficacy and safety results of ABT-414 in combination with radiation and temozolomide in newly diagnosed glioblastoma. Neuro Oncol. 2017 Jul 1;19(7):965-975. doi: 10.1093/neuonc/now257.

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 and 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.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
South Africa
Czechia
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Mexico
Singapore
Brazil
Canada
Switzerland
China
Germany
Taiwan
Ireland
New Zealand
Korea, Republic of
France
Colombia
Netherlands

location_facility: Linkou Chang Gung Memorial Ho /ID# 143941

location_facility: St. Josephs Hospital and Med Center /ID# 144149

location_facility: Royal Victoria Hospital / McGill University Health Centre /ID# 144187

location_facility: Duplicate_Univ Hosp Ostrava-Poruba /ID# 143883

location_facility: State budgetary healthcare institution Republican Clinical Oncology Dispensary /ID# 141706

location_facility: Tel Aviv Sourasky Medical Center /ID# 143956

location_facility: University of Free State, Universitas Annex (National Hospital Grounds) /ID# 144064

location_facility: Baylor Sammons Cancer Center /ID# 155542

location_facility: Hospital Santa Creu i Sant Pau /ID# 143900

location_facility: Regional Clinical Hospital of Kaliningrad region /ID# 141702

location_facility: Maastricht Universitair Medisch Centrum /ID# 143585

location_facility: Centro Medico Imbanaco de Cali /ID# 143882

location_facility: Duplicate_Canterbury District Health Boa /ID# 143861

location_facility: Duplicate_Xiangya Hospital Central South University /ID# 166791

location_facility: Krajska nemocnice Liberec, a.s. /ID# 142024

location_facility: Leeds Teaching Hospitals NHS Trust /ID# 141653

location_facility: Univ of Colorado Cancer Center /ID# 148194

location_facility: Highlands Oncology Group Springdale /ID# 142050

location_facility: The Chaim Sheba Medical Center /ID# 143960

location_facility: Northwestern University Feinberg School of Medicine /ID# 147895

location_facility: Duplicate_Hospital Maisonneuve-Rosemont /ID# 149315

location_facility: Duplicate_Huashan Hospital of Fudan University /ID# 159999

location_facility: AP-HM - Hopital de la Timone /ID# 143911

location_facility: Duplicate_Yonsei University Health System, Severance hospital. /ID# 141846

location_facility: Vrije Universiteit Medisch Centrum /ID# 143889

location_facility: Duplicate_Royal Marsden Hospital /ID# 142827

location_facility: NorthShore University HealthSystem /ID# 144017

location_facility: Penn State University and Milton S. Hershey Medical Center /ID# 147525

location_facility: Institut de Cancérologie de l'Ouest René Gauducheau /ID# 143914

location_facility: Duplicate_Duplicate_AOU Citta della Salute Scienza /ID# 141801

location_facility: Virginia Commonwealth University Medical Center Main Hospital /ID# 149014

location_facility: Hospital Universitario 12 de Octubre /ID# 143930

location_facility: The First Affiliated Hospital of Soochow University /ID# 165596

location_facility: Gastroenterology Institute, Division of Medicine /ID# 143958

location_facility: GEMC - European Medical Center /ID# 141703

location_facility: Duplicate_Scott and White Medical Center /ID# 160743

location_facility: Levine Cancer Ins, Carolina Me /ID# 144124

location_facility: Sverdlovsk Regional Oncology Dispensary /ID# 141700

location_facility: Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 141939

location_facility: Beijing Tian Tan Hospital, Capital Medical University /ID# 167160

location_facility: Taipei Veterans General Hosp /ID# 143955

location_facility: Associated Neurologists of Sou /ID# 147701

location_facility: Duplicate_Medizinische Universitat Innsbruck,Universitatsklinik fur Innere Mediz /ID# 141984

location_facility: Administradora del Country_S.A-Clinica Del Country /ID# 143881

location_facility: Rutgers Cancer Institute of New Jersey /ID# 148190

location_facility: Cedars-Sinai Medical Center-West Hollywood /ID# 148472

location_facility: The University of Chicago Medical Center /ID# 144158

location_facility: Universitaetsklinikum Leipzig /ID# 143962

location_facility: University of Southern California /ID# 147543

location_facility: University Hospitals Birmingham NHS Foundation Trust /ID# 154592

location_facility: Centro Medico Zambrano Hellion /ID# 143845

location_facility: Emory Midtown Infectious Disease Clinic /ID# 144015

location_facility: Universitaetsklinikum Tuebingen /ID# 143926

location_facility: SanboBrain Hospital Capital Medical University /ID# 166422

location_facility: Dana-Farber Cancer Institute /ID# 148475

location_facility: Instituto do Câncer do Estado de São Paulo - ICESP /ID# 144031

location_facility: Virginia Mason Medical Center /ID# 144022

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 141844

location_facility: Boca Raton Regional Hospital /ID# 163659

location_facility: Sun Yat-Sen University Cancer Center /ID# 143919

location_facility: Medizinische Universitaet Graz /ID# 141982

location_facility: Medizinische Universitaet Wien /ID# 141981

location_facility: Duplicate_The Second Affiliated Hospital of ZUSM /ID# 165593

location_facility: Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbH /ID# 143961

location_facility: Universitaetsklinik Heidelberg /ID# 143927

location_facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 163820

location_facility: Univ of Wisconsin Hosp/Clinics /ID# 144167

location_facility: Duplicate_Cancer Care Manitoba /ID# 149253

location_facility: Hospital Clinic de Barcelona /ID# 143906

location_facility: Inselspital, Universitätsspital Bern /ID# 141886

location_facility: MD Anderson Cancer Center at Cooper - Camden /ID# 145891

location_facility: Washington University-School of Medicine /ID# 144174

location_facility: Duplicate_The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 141999

location_facility: Princess Margaret Cancer Centre /ID# 166277

location_facility: Duplicate_Shengjing Hospital of China Medical University /ID# 167016

location_facility: Duplicate_Regina Elena National Cancer I /ID# 141795

location_facility: Froedtert Memorial Lutheran Hospital /ID# 144139

location_facility: University of Texas MD Anderson Cancer Center /ID# 144018

location_facility: National Taiwan University Hospital /ID# 143940

location_facility: Hospital Clinico Universitario San Carlos /ID# 143901

location_facility: Liga Norte Riograndense Contra o Câncer /ID# 143878

location_facility: University of California, Los Angeles /ID# 149239

location_facility: Maine Medical Partners Neurolo /ID# 160864

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 142830

location_facility: Duplicate_Tianjin Med Univ General Hosp /ID# 143923

location_facility: University of Nebraska Medical Center /ID# 145899

location_facility: Univ California, San Francisco /ID# 145889

location_facility: Duplicate_EOC Ospedale Regionale di Bellinzona e Valli /ID# 143936

location_facility: Medical University of South Carolina /ID# 144141

location_facility: University College London Hospitals NHS Foundation Trust /ID# 142658

location_facility: Kepler Universitätsklinikum GmbH - Neuromed Campus /ID# 141983

location_facility: Duplicate_Jewish General Hospital /ID# 144029

location_facility: Duplicate_Centre Hospitalier Jolimont /ID# 143873

location_facility: Cleveland Clinic Main Campus /ID# 144023

location_facility: Duplicate_Wellington Hospital (Capital and Coast District Health Board) /ID# 143890

location_facility: Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 147223

location_facility: Calvary North Adelaide Hospita /ID# 143866

location_facility: National Medical Research Center for Neurosurgery n.a. N. N. Burdenko /ID# 141701

location_facility: St Vincent's Hospital Melbourne /ID# 143858

location_facility: Duplicate_Instituto Med Alex Flem /ID# 142884

location_facility: University of Pennsylvania Medical Center - Shadyside /ID# 144159

location_facility: The University of Texas Health Science Center at Houston /ID# 144013

location_facility: Southern Medical Day Care Centre /ID# 143868

location_facility: Universitair Ziekenhuis Leuven /ID# 143872

location_facility: Duplicate_St. John's Health Center /ID# 148192

location_facility: CCA Braga - Hospital de Braga /ID# 141940

location_facility: Duplicate_The Prince of Wales Hospital /ID# 144882

location_facility: QE II Health Sciences Centre /ID# 151600

location_facility: CHU de Quebec-Universite Laval /ID# 144189

location_facility: Federal State Budgetary Scientific Institution N.N. Blokhin /ID# 141707

location_facility: Guy's and St Thomas' NHS Foundation Trust /ID# 142652

location_facility: Hospital Universitario HM Sanchinarro /ID# 143496

location_facility: Peking Union Medical College Hospital /ID# 157430

location_facility: Velindre University NHS Trust /ID# 141996

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 143915

location_facility: Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 141941

location_facility: Intermountain Medical Center /ID# 144142

location_facility: Netcare Oncology Intervent Ctr /ID# 143951

location_facility: Federal State Treatment and Rehabilitation center /ID# 141704

location_facility: Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 143877

location_facility: Northwestern Medicine Cancer Center - Warrenville /ID# 148476

location_facility: St John Of God Subiaco Hospital /ID# 143869

location_facility: National Cancer Ctr Singapore /ID# 143932

location_facility: Duplicate_St. Joseph Mercy Hospital /ID# 144143

location_facility: Duplicate_Univ Hosp Cleveland /ID# 144153

location_facility: Columbia University Medical Center /ID# 144020

location_facility: Universitair Medisch Centrum Utrecht /ID# 141406

location_facility: Univ Kansas Cancer Ctr - Overl /ID# 145895

location_facility: Duplicate_Cape Town Oncology Trials /ID# 143948

location_facility: Universitair Medisch Centrum Groningen /ID# 141408

location_facility: Hospital General Universitario de Valencia /ID# 143903

location_facility: National University Hospital /ID# 143933

location_facility: The First Affiliated Hospital of Fujian Medical University /ID# 159166

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 141800

location_facility: Christiana Care Health Service /ID# 144127

location_facility: Seoul National University Hospital /ID# 143886

location_facility: Massachusetts General Hospital /ID# 144145

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 143876

location_facility: Ottawa Hospital Research Institute /ID# 150120

summary:
This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide (TMZ) followed by combination of ABT-414 with adjuvant TMZ prolongs overall survival (OS) among participants with newly diagnosed glioblastoma (GBM) with epidermal growth factor receptor (EGFR) amplification.

In addition, there is a Phase 1, open-label, multicenter sub-study to assess the pharmacokinetics, safety and tolerability of ABT-414 in participants with newly diagnosed EGFR-amplified GBM who have mild or moderate hepatic impairment.


title: A Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of 24 Weeks Treatment With REN001 in Patients With Primary Mitochondrial Myopathy

acronym: STRIDE

summary: This is a randomized, double-blind, placebo-controlled, parallel group, multi-centre, study designed to investigate the efficacy and safety of REN001 administered once daily over a 24-week period to patients with PMM.

ipd_sharing: No

lead_sponsor: Reneo Pharma Ltd

location_country:
Denmark
Spain
Italy
United Kingdom
Australia
New Zealand
Canada
Hungary
United States
France
Belgium
Germany
Czechia

location_facility: Myology Institute, University of Florida

location_facility: Centre Hospitalier Universitaire d' Angers

location_facility: University of Texas SouthWestern Medical Center

location_facility: University of Pécs Clinical Centre, Department of Neurology

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Neurophysiopathology Unit

location_facility: A.O.U Policlinico di Messina U.O.C Neurologia e Malattie Neuromuscolari

location_facility: Queen Square Centre for Neuromuscular Diseases

location_facility: Fondazione IRCCS Istituto Neurologico "Carlo Besta" UOC Genetica Medica e Neurogenetica

location_facility: University Hospital Bonn Clinic and Polyclinic for Neurology

location_facility: Semmelweis University Insitute of Genomics and Rare Disorders

location_facility: Rigshospitalet, University of Copenhagen

location_facility: IRCCS Ospedale Pediatrico Bambino Gesù, UOC Malattie Muscolari e Neurodegenerative

location_facility: M.A.G.I.C. Clinic (Metabolics and Genetics in Calgary)

location_facility: Azienda Ospedaliero-Universitaria Pisana Dipartimento di specialita' mediche UOC Neurologia

location_facility: Columbia University Irving Medical Center

location_facility: Medical Center of the University of Munich Friedrich Baur Institute at the Neurological Clinic and Polyclinic

location_facility: Centre for the Treatment of Pediatric Neurodegenerative Disease, University of Texas McGovern Medical School

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Adult Metabolic Diseases Clinic, Vancouver General Hospital

location_facility: Hospital Universitari i Politècnic La Fe


title: Measure of Vaccine Effectiveness to Prevent Hospitalizations for Viral Respiratory Infections in Adults

acronym: RESPIVAC

summary: This study is a prospective, multicentric, observational test negative design study on adults hospitalized for Severe Acute Respiratory Infection (SARI), regardless of their vaccination status.

study_start_date_type: Anticipated

status: Not yet recruiting

study_type: Observational

time_perspective: Prospective

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility:
Hôpital Gui de Chauliac
Groupement hospitalier Edouard Herriot
Hôpital Cochin
CHU
Hôpital Bichat

lead_sponsor_type: academique


title: COVID-19 and Rare Skin Diseases. European Observational Study (Data Research) During an Epidemic

summary: This is a European observational cohort study (data research) involving multiple centres to look at the potential impact of COVID infection on patients with rare skin diseases examining factors such as comorbidity, protection factors, and clinical and/or therapeutic factors. The data collected may provide additional information on the situation of patients and, on a wider basis, provide useful data applicable to the general population.

time_perspective: Other

lead_sponsor: Imagine Institute

location_country: Italy Lithuania France Germany Czechia

location_facility: Städtisches Klinikum Dessau, Dessau Medical Center

location_facility: University Hospital Brno - EB Centrum CR Dermatolog

location_facility: University Hospital of Erlangen - ZSEER - Zentrum für Seltene Erkrankungen Erlangen

location_facility: Hôpital Necker - Enfants malades (AP-HP)

location_facility: Hospital of Lithuanian University of Health Sciences Kauno Klinikos

location_facility: IRCCS Ca' Granda Ospedale Maggiore Policlinico


title: A Multicenter, Interventional, Open-label Study to Monitor the Evolution of Motor Function in SMA Type II Adults Patients Treated With SPINRAZA®

acronym: SMAII

summary: SPINRAZA® (Nusinersen) is the first intrathecal administered drug which was approved by the FDA to treat SMA children and adults (2016). The aim is to monitor the evolution of the Motor Function Measure-32 for SMA type II adult patients treated with SPINRAZA® (Nusinersen).

primary_purpose: Other

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CHU de Nice
CHU de Lyon
APHP
CHU de Toulouse
Hopital de la Timone - APHM
CHU de Montpellier
CHRU de Lille

intervention_type: Other


title: "Effect of the Consumption of a Fermented Dairy Product on Gastrointestinal Well-being in a Healthy Population of Women With Minor Digestive Symptoms"

summary: The purpose of this study is to evaluate the effect of a commercially available fermented dairy product containing probiotics (4 weeks, twice a day) on the improvement of gastrointestinal well being and digestive symptoms in adult women reporting minor digestive troubles among the general population.

primary_purpose: Prevention

lead_sponsor: Danone Research


title: PREVALENCE STUDY OF FIBROMUSCULAR DYSPLASIA IN PATIENTS WITH HAEMATOMA OR SPONTANEOUS CORONARY ARTERY DISSECTION

acronym: DISCO

summary:
Spontaneous Coronary Artery Dissection (SCAD) is a rare and often misdiagnosed cause of Acute Coronary Syndrome (ACS) affecting predominantly young women without cardiovascular risk factors. The origin of SCAD remains uncertain but a strong and frequent association with Fibromuscular Dysplasia (FMD) has been recently reported based on imaging evidence only.

The aim of our study is to assess the presence of FMD and its genetic determinants i in a sample for haematoma or spontaneous coronary artery dissection.

From May 2016 to 2018 we plan to include prospectively and retrospectively 200 patients admitted for ACS with confirmed diagnosis of SCAD. This study will be conducted in more than 30 French interventional cardiology centers. Coronary angiograms or intracoronary imaging data will be reviewed by two experienced interventional cardiologist experts in SCAD diagnosis.

For each patient a genetic analysis will be performed. A systematic screening for FMD will be realized by computed tomographic or MRI angiography of renal, cerebrovascular and iliac arteries and reviewed by two experienced radiologists. A one year follow-up is expected.

This study aims to confirm the presumed association of FMD and SCAD through the exploration of several artery beds and the study of confirmed genetic determinants, which has never been described previously to our knowledge.

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Procedure


title: Essure Removal for Device-attributed Symptoms: Quality of Life Evaluation Before and After Surgical Removal

acronym: ESSURE

summary:
In recent years, several symptoms have been attributed to Essure, including pelvic pain and other general symptoms. Consequently, an increasing number of patients request Essure removal for alleged adverse reactions to the device.

Study Objective: To evaluate the quality of life of patients who underwent Essure_ device removal and morbidity of this surgery.

Design: Prospective observational cohort study. Setting: Academic hospitals of La Conception, Marseille, and Arnaud-de-Villeneuve, Montpellier, France.

Patients: Women who underwent Essure_ device removal by salpingectomy, between February 2017 and August 2018.

Methods : The following information have been collected during preoperative clinics: demographic data, medical history, clinical symptoms attributed to the Essure device, time between Essure sterilization and early symptoms, time between the beginning of symptoms and surgical removal. Follow-up visits have benne scheduled at one month and three months post-operation. The evolution of symptoms was collected during the follow-up visit at three months based on clinical reports and a dedicated questionnaire. Evaluation of Quality of life have been evaluated thanks to SF36 and HAD questionnaires. Alle these patients will be contacted by phone call to assess to evolution of symptoms and to complete SF 36 and HAD questionnaires.

Hypothesis : Recovery of symptoms due to ESSURE device and improvement of quality of life after surgery.

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: A Retrospective Non-interventional Descriptive Epidemiology Study for Patients With Paraphilia Sex Offenders Receiving Androgen Antagonists Treatment

acronym: EPIPARA

summary:
The main objective of the study is to describe the french population of individuals with paraphilia who have committed a sexual offence in whom androgen antagonists was prescribed. The secondary objectives are the description of social demographic profiles, the personal and family histories,psychiatric co-morbidities, the side effects of androgen antagonists treatment. This study, the first of its kind in France, may allow to better understand the social demographic and clinical profile of sexual offenders with paraphilias treated with androgen antagonists.

To be included, the subject must have committed a sexual offense and must present a diagnosis of paraphilia with an indication of treatment with androgen antagonists. Paraphilia is defined by the Diagnostic and Statistical Manual as a sexual behavior disorder characterized by "sexually arousing fantasies, needs or recurrent and intense sexual behaviors generally involving (1) of non-human objects, (2) the suffering or humiliation of oneself or partner, (3) children or other persons without their consent, occurring during a period of at least six months "(Criterion A). This disorder is responsible for sexual behavior which is "clinically significant disturbances in social, occupational or other important areas of functioning" (Criterion B).

The inclusion of approximately 200 subjects is expected in this study. The inclusion period will last for 12 months.

Data will be codified and only a few investigators will have access to these data. The statistical analyse will use the usual descriptive parameters: mean, standard deviation, median, interquartile range and range for quantitative variables, frequencies and cumulative frequencies (if applicable) for qualitative variables.

time_perspective: Retrospective

lead_sponsor: University Hospital, Rouen


title: Study of the Factors Favoring the Transition From Prediabetes to Diabetes on Reunion Island. Impact of the "Say No to Diabetes" Intervention.

acronym: PREDIABRUN

summary:
The management of diabetes and its complications in Reunion island is one of the priority areas of health. Indeed, the impact of diabetes on the health of the Reunion island population is major: the prevalence of diabetes treated in Reunion island is the highest in France (10% of the population), and gestational diabetes is found in 10% of pregnancies. Reunionese diabetics develop severe complications, in particular cardiovascular (strokes, myocardial infarction).

This results in 3 times higher mortality linked to diabetes on Reunion Island, in particular among those under 65 years of age. Despite all the screening and prevention programs put in place, the weight of diabetic disease continues to increase in our island, and this is more accelerated than in the other French departments with 4,300 new cases of diabetes / year, 95% of which type 2 diabetics (T2D). The presentation of type 2 diabetic patients in Reunion island also differs from the Metropolis with subjects more often female (56%), thinner and younger at the discovery of diabetes. These data highlight the need to better understand the factors underlying the diabetes "epidemic" in Reunion island.

The rise in blood sugar until the onset of diabetes is a continuous phenomenon reflecting the progressive suffering of the organs used to maintain carbohydrate homeostasis. Thus, we talk about fasting hyperglycemia when the fasting blood sugar is between 1.10 and 1.25 g / L (6.1-6.9 mmol / l) and glucose intolerance when the blood sugar 2 hours after taking 75 g of glucose is between 1.40 and 1.99 g / L (7.8-11.0 mmol / l). Subjects with fasting hyperglycemia or glucose intolerance constitute the target population at very high risk of developing diabetes (up to 70% of these subjects). They have an increased risk of developing diabetes at 1 year multiplied by 5 to 10 compared to normoglycemic subjects, hence the name "prediabetic subjects". This great variability in the risk of developing diabetes highlights the presence of associated risk / protective factors which it is important to find in order to adapt the monitoring and management. It is important in Reunion island, in view of the specificities presented by our population, to understand the pre-diabetes / diabetes transition and the risk and protective factors.

lead_sponsor: Centre Hospitalier Universitaire de la Réunion


title: Study of Food Preferences After Bariatric Surgery

summary:
Bariatric surgery is currently considered the most effective treatment for achieving significant, sustained weight loss and reducing comorbidities associated with obesity. Every year in France, more than 55,000 undergo this surgery and nearly 450 000 French have a history of surgery for obesity. The mechanisms of action of bariatric surgery are multiple and are not limited to caloric restriction. Neuro-hormonal effects, changes in the anatomy of the digestive tract, vagal changes or bile circulation have been identified as contributing factors to weight loss and postoperative improvement of comorbidities. In addition, post-operative changes in dietary preferences have also been described, which could contribute to initial weight loss and its maintenance over time (aversion to lipid and sugar products).

The counterpart of the rapid and durable efficacy of bariatric surgery is the exposure of patients to a significant risk of protein-energy malnutrition. It should be noted that the protein intake, very limited in the first months after surgery, remains well below the recommended intake after the first postoperative year. Spontaneous consumption of meat and vegetable protein is significantly reduced during the first postoperative month and up to one year after surgery. Apart from the limitation of gastric volume induced by surgery, clinical experience indicates that many patients turn away from protein consumption by aversion. A parallel was made between the significant drop in protein consumption during the first months and the initial loss of lean mass. Thus changes in dietary preferences induced by bariatric surgery could also contribute to postoperative nutritional risk (protein aversion).

At the same time, it is noted that olfactory and taste modifications have been reported in previous studies that could be associated with these changes in food preferences.

The hypotheses of the current study are that the type of surgery may affect dietary preferences differently after obesity surgery and that surgical failure may be associated with preferences for high fat, high sweet and low protein foods postoperatively for both types of surgery.

As far as the investigating team is aware, no study compares dietary preferences between sleeve gastrectomy and gastric bypass using this approach.

time_perspective: Cross-Sectional

lead_sponsor: Hospices Civils de Lyon


title: Efficacy and Toxicity of Blinatumomab in the French Compassionate Use Program (ATU) for Adult Patients With B-cell Precursor Acute Lymphoblastic Leukemia (BCP-ALL) Refractory, in Relapse, or With Positive Minimal Residual Disease.

acronym: FRENCH-CYTO

summary:
The outcome of young adults (18-60 years) with ALL has been dramatically improved by the use of pediatric-inspired trials. About 60% of these young adult patients will be cured at 5 years. In this context, early evaluation of minimal residual disease (MRD) at complete remission has been shown to be one of the most powerful prognostic factor, but also predictive of the benefit of allogeneic stem cell transplantation (ASCT). Despite this global improvement, about 30% of patients experience a relapse and will be exposed to be refractory to salvage therapy or to early disease escape. In adult ALL, the most important prognostic factors at relapse are : the time from first CR to relapse, the achievement of a second complete remission (CR), and the feasibility of ASCT.

Blinatumomab is a bispecific T-cell engager that recruits T-cell on CD19 positive blast cells and induces anti-leukemic cytotoxicity. In a phase 3 trial in relapse/refractory Philadelphia-negative (Ph-) ALL, 43% of patients achieved a CR or CR with partial hematological recovery (CRh), with the majority of responses occurring within the first cycle. In patients with positive MRD (MRD+) BCP-ALL, blinatumomab resulted in complete MRD response in 78% of patients after one cycle.

Between 2012 and 2016, blinatumomab was available in France for R/R and MRD+ ALL adult patients through the French Compassionate Use Program. About 92 adult ALL were treated at different stages of the disease in 27 centers.

status: Unknown status

ReferenceType: background

ReferenceCitation: Dombret H, Cluzeau T, Huguet F, Boissel N. Pediatric-like therapy for adults with ALL. Curr Hematol Malig Rep. 2014 Jun;9(2):158-64. doi: 10.1007/s11899-014-0210-9. Review.

ReferenceCitation: Dhédin N, Huynh A, Maury S, Tabrizi R, Beldjord K, Asnafi V, Thomas X, Chevallier P, Nguyen S, Coiteux V, Bourhis JH, Hichri Y, Escoffre-Barbe M, Reman O, Graux C, Chalandon Y, Blaise D, Schanz U, Lhéritier V, Cahn JY, Dombret H, Ifrah N; GRAALL group. Role of allogeneic stem cell transplantation in adult patients with Ph-negative acute lymphoblastic leukemia. Blood. 2015 Apr 16;125(16):2486-96; quiz 2586. doi: 10.1182/blood-2014-09-599894. Epub 2015 Jan 13.

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lead_sponsor: Group for Research in Adult Acute Lymphoblastic Leukemia

status_simplified: Unknown


title: Evaluation of Safety and Efficacy of the FRED and FRED JR Devices for Intracranial Aneurysm Treatment

summary: A French, multicenter, prospective, observational, "real-world" assessment of the safety and efficacy of FRED and FRED Jr devices in the treatment of intracranial aneurysms

lead_sponsor: Microvention-Terumo, Inc.

intervention_type: Device


title: Osteoporosis Awareness Survey of Women in Champagne Ardenne

acronym: MPCosteoporose

summary:
Osteoporosis is characterized by low bone mineral density and alterations in bone microarchitecture, leading to bone fragility and high risk of fractures. In the peri-menopausal period and during menopause, estrogen deficiency is responsible for an acceleration of bone remodeling. It is therefore important to sensitize women to this pathology at the beginning of menopause.

Osteoporosis is a public health issue with more than 3 million women in France suffering from almost ¼ of the population over 50 years old. Paradoxically, the number of bone densitometry and prescribed osteoporosis drugs are decreasing. There is an under-screening and a disinterest of the pathology on the part of the medical world and the patients.

The investigators hypothesize that women lack knowledge about osteoporosis. This study will identify these gaps, and put in place appropriate strategies to improve this knowledge.

For this purpose, a descriptive cross-sectional observational study will carry out, through the fulfillment of self-administered questionnaire for women over 30 years old. The main objective is to assess the knowledge of women, about osteoporosis and its consequences. The judgment criterion is based on a percentage of correct answers per question. The interests of the study are to identify gaps in knowledge, to optimize the investigator's therapeutic education, to fight patient wait-and-see and false beliefs, and finally to improve adherence and longer-term adherence.

lead_sponsor: CHU de Reims


title: Bone Health in Adolescents and Young Adults With Oral Macro-progestin Treatment : Observational Study

acronym: MACROS

summary:
Many factors are known to influence the acquisition of bone capital, especially estrogens in women. Estrogens have a major role in bone growth and the acquisition of bone mass peaks during puberty. This peak of bone mass is an important determinant of the risk of osteoporotic fracture in adulthood.

It is known that estrogen deficiency increases the rate of bone remodeling and engenders an imbalance between resorption and bone formation, which can lead to osteoporosis.

Oral estroprogestin contraceptives have an anti-gonadotropic effect and suppress estrogen secretion by the ovaries.

However, studies in adolescents and young adults are rare and evidence of an effect on bone is still inconclusive, although there is increasing evidence that oral estroprogestin contraceptives in teenage girls may compromise the performance of the bone mass.

Macro progestins treatments are prescribed in France to patients with contraindications to estroprogestin treatments. This practice is french and few recommendations exist on the use of these molecules by the oral route. There are no studies that describe the impact of these oral treatments on the bone health of young women treated.

The Department of endocrinology, gynecology and pediatric diabetes of Necker-Enfants Malades hospital, follows many young girls taking a macro progestin treatment. This study is exclusively descriptive and will focus on the clinical and medical datas available on the bone health of these patients.

status: Withdrawn

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Non-respiratory Comorbidities Observed in Pulmonary French Transplant Patients With Cystic Fibrosis - Exploratory Study From the French Cohort on 2004-2014.

acronym: MUCO TRANSPLAN

summary:
Pulmonary transplantation is the reference treatment for chronic terminal respiratory failure in patients with cystic fibrosis. These are mainly bi-pulmonary transplants (cardiopulmonary transplants are exceptional). The annual number of pulmonary transplants in France for cystic fibrosis is about 90. In 2013, the transplant involves a total of more than 600 patients with cystic fibrosis. The average age at the time of the transplant is 28.5 years (2013 data, French cystic fibrosis register), compared to 58 years for patients transplanted to all pathologies. Cystic fibrosis accounts for 25% of adult bi-pulmonary grafts. Pediatric transplants are currently very rare.

The median survival after pulmonary transplantation in cystic fibrosis is currently 8.5 years (and 10 years when considering patients surviving 3 months, ie excluding early mortality). Cystic fibrosis is the pathology associated with better survival after pulmonary transplantation given the young age of patients (28.5 years on average).

The non-respiratory comorbidities associated with transplantation, all underlying pathologies combined, and referenced in the Registry of the International Society for Heart and Lung Transplantation (ISHLT) are: hypertension, diabetes, renal insufficiency, Dyslipidemia, cancers. Their frequency increases with the survival time of transplanted patients. Cystic fibrosis is associated with non-respiratory comorbidities, the frequency of which increases with age - diabetes, osteoporosis, renal insufficiency, hepatopathy, neoplastic pathologies - and may become worse after transplantation.

The main objective is to estimate the incidence of non-respiratory co-morbidities after lung transplantation in the cohort of patients with cystic fibrosis grafted in the Rhône-Alpes region.

location_facility: Service de médecine interne Centre Hospitalier Lyon Sud, Hospices Civils de Lyon


title: Evaluation of Pneumococcal Vaccine Coverage

acronym: SAUVAC

summary:
Pneumococcal infections are frequent and serious. Streptococcus pneumoniae is the leading cause of community-acquired pneumonia in adults. In metropolitan France, there are 6000 to 7000 bacteremic pneumococcal infections each year, with a mortality rate of 10 to 30% in adults.

To fight against these bacterial infections, vaccines have been developed. At a time when antibiotic savings and the fight against antimicrobial resistance are major public health issues, vaccination is a first choice option to slow the development of pneumococcal resistance. Thus, after these different actions, the proportions of pneumococci with decreased susceptibility to penicillin G fell from 53 to 22%.

While there is a significant decrease in invasive pneumococcal disease in children since the use of conjugate vaccines (vaccination of up to 94% of children), the rate of invasive Pneumococcal disease in adults has decreased less significantly.

In March 2017, the High Council of Public Health (HCSP) proposed the vaccination of all non-immunocompromised adults at risk and immunocompromised patients.

Awareness-raising among vaccinating physicians seems essential, especially in recent years when the value of vaccination is threatened by speculation about its efficacy and toxicity. However, the investigators know that vaccination aims not only to protect the individual, but also the population, especially children and the elderly and the fragile people.

Thus, in the context of pneumococcal vaccination, identifying one or more profiles of patients at risk in the absence of vaccination could be particularly beneficial. Indeed, if the physician knows about the population at risk of not being vaccinated, it will be better able to identify patients at risk of not being protected against pneumococcus.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Rapid Diagnosis of COVID-19 by Chemical Analysis of Exhaled Air

acronym: COVIDAIR

summary:
Since the start of 2020, the new SARS-CoV-2 coronavirus is causing a real global health crisis.

In France, nasopharyngeal swabs are used to obtain the sample needed for respiratory infection screening. There are three major difficulties with this type of sampling:

I) It is really unpleasant for the patient because the device has to be pushed into the nostril to reach the nasopharynx. It causes some patients to bleed or even feel uncomfortable.

II) It is not easily accepted by children. III) It is dependent on the availability of swabs. Faced with these difficulties linked to the initial sampling, new methods are being studied to enable a rapid and non-invasive diagnosis of COVID-19 based on the instantaneous identification of metabolites or volatile organic compounds (VOCs).

Due to their sensitivity and the wealth of information that can be provided, the most promising techniques are based on mass spectrometry coupled with a soft ionisation system. For example, on-line exhaled air analysis is capable of detecting a very large number of VOCs. Various tests on metabolites in the exhaled air have already been carried out without being totally conclusive because the existing instruments suffer from various limitations:

I) poor repeatability/accuracy in the chemical characterisation of exhaled air ; II) too high specificity (detection of only part of the emitted compounds); III) too limited sensitivity; IV) and poor adaptation to be deployed in a clinic.

In order to overcome these various limitations, we propose the use of a new generation of mass spectrometer: Vocus PTR-TOF. The Vocus PTR-TOF is a Proton Transfer Mass Spectrometer (PTR-MS) developed for the detection, in real time, of trace VOCs in industrial environments, laboratories or directly in the environment. This new generation of instrument offers the following advantages:

I) unequalled sensitivity :

II) a robust ionisation system not affected by environmental conditions (relative humidity...) ; III) a high mass resolution allowing precise identification of compounds ; IV) a compact and durable architecture allowing deployment in a constrained environment such as hospital, airport… The sensitivity and speed of measurement allow the expiration process to be monitored in real time, bringing an additional dimension to the measurement and the chances of success.

location_facility: Centre de prélèvement COVID-19 HCL et Métropole de Lyon

intervention_type: Diagnostic Test