ReferenceCitation: Galsky MD, Hoimes CJ, Necchi A, Shore N, Witjes JA, Steinberg G, Bedke J, Nishiyama H, Fang X, Kataria R, Sbar E, Jia X, Siefker-Radtke A. Perioperative pembrolizumab therapy in muscle-invasive bladder cancer: Phase III KEYNOTE-866 and KEYNOTE-905/EV-303. Future Oncol. 2021 Aug;17(24):3137-3150. doi: 10.2217/fon-2021-0273. Epub 2021 May 19.

name: Department of Medicine, Icahn School of Medicine at Mount Sinai, NY 10029, USA

family: Galsky

full_name: Matthew D Galsky

given: Matthew D

name: Department of Medicine, Duke University, Durham, NC 27710, USA

family: Hoimes

full_name: Christopher J Hoimes

given: Christopher J

name: Department of Medical Oncology, Vita-Salute San Raffaele University & IRCCS San Raffaele Hospital, Milan, 20132, Italy

family: Necchi

full_name: Andrea Necchi

given: Andrea

name: Department of Urology, Carolina Urologic Research Center, Myrtle Beach, SC 29577, USA

family: Shore

full_name: Neal Shore

given: Neal

name: Department of Urology, Radboud University, Nijmegen Heyendaal 6500, The Netherlands

family: Witjes

full_name: J Alfred Witjes

given: J Alfred

name: Department of Urology, NYU Langone Health, NY 10017, USA

family: Steinberg

full_name: Gary Steinberg

given: Gary

name: Department of Urology, Eberhard Karls Universität Tübingen, Tübingen, 72076, Germany

family: Bedke

full_name: Jens Bedke

given: Jens

name: Department of Urology, University of Tsukuba, Ibaraki, 305-8575, Japan

family: Nishiyama

full_name: Hiroyuki Nishiyama

given: Hiroyuki

name: Department of Clinical Research, Merck & Co., Inc., Kenilworth, NJ 07033, USA

family: Fang

full_name: Xiao Fang

given: Xiao

family: Kataria

full_name: Ritesh Kataria

given: Ritesh

family: Sbar

full_name: Eric Sbar

given: Eric

family: Jia

full_name: Xieyang Jia

given: Xieyang

name: Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA

family: Siefker-Radtke

full_name: Arlene Siefker-Radtke

given: Arlene

journal_name: Future Oncology

oa_host_type: publisher

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

intervention_type: Procedure

location_country:
Belgium
Australia
Russian Federation
Denmark
Ukraine
France
Japan
Poland
Thailand
Canada
Korea, Republic of
Sweden
Hungary
Ireland
United States
Germany
United Kingdom
Italy
Mexico
Israel
Spain
Turkey

location_facility: Fondazione Salvatore Maugeri IRCCS. ( Site 0554)

location_facility: Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi ( Site 0904)

location_facility: Europejskie Centrum Zdrowia Otwock ( Site 1057)

location_facility: Cherkasy Regional Oncology Dispensary ( Site 0959)

location_facility: Sunnybrook Research Institute ( Site 0110)

location_facility: Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0502)

location_facility: Tokushima University Hospital ( Site 1514)

location_facility: Seoul National University Hospital ( Site 1352)

location_facility: UNM Comprehensive Cancer Center-Clinical Research Office ( Site 0045)

location_facility: Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0901)

location_facility: Providence Saint John's Health Center ( Site 0075)

location_facility: Omsk Clinical Oncology Dispensary ( Site 0865)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0910)

location_facility: Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 0969)

location_facility: Clinical Hospital Saint Luka ( Site 0867)

location_facility: CNPE "Regional Center of Oncology" ( Site 0958)

location_facility: Odense Universitetshospital ( Site 0403)

location_facility: Inova Schar Cancer Institute ( Site 0007)

location_facility: Osaka City University Hospital ( Site 1512)

location_facility: Tallaght University Hospital ( Site 0710)

location_facility: Instituto Valenciano de Oncologia - IVO ( Site 0662)

location_facility: Mid North Coast Cancer Institute ( Site 1256)

location_facility: University Hospital Waterford ( Site 0723)

location_facility: National Cancer Institute of the MoH of Ukraine ( Site 0962)

location_facility: Kingston Health Sciences Centre ( Site 0103)

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0021)

location_facility: Georgetown University Medical Center ( Site 0022)

location_facility: CHU de Bordeaux- Hopital Saint Andre ( Site 0456)

location_facility: Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 0951)

location_facility: Imperial College Healthcare NHS Trust ( Site 0721)

location_facility: Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 0725)

location_facility: Hadassah Ein Kerem Medical Center ( Site 0810)

location_facility: Hospital San Pedro de Alcantara ( Site 0654)

location_facility: Northwest Medical Specialties, PLLC ( Site 0061)

location_facility: Assaf Harofeh Medical Center ( Site 0805)

location_facility: CHU de Montpellier - Hopital Saint-Eloi ( Site 0469)

location_facility: Hospital Universitario San Carlos ( Site 0663)

location_facility: Policlinico Gemelli di Roma ( Site 0558)

location_facility: Azienda Ospedaliera Santa Maria Terni ( Site 0557)

location_facility: Hospital Nuestra Sra. de Valme ( Site 0658)

location_facility: New England Cancer Specialists ( Site 0070)

location_facility: Faculty of Medicine Siriraj Hospital ( Site 1452)

location_facility: Korea University Anam Hospital ( Site 1351)

location_facility: Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 1068)

location_facility: Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0033)

location_facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori ( Site 0552)

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1002)

location_facility: Clinic of Bashkortostan State Medical University ( Site 0869)

location_facility: Institut de Cancerologie de l Ouest Site Paul Papin ( Site 0453)

location_facility: Central Clinical Hospital with outpatient Clinic ( Site 0856)

location_facility: Universitaetsklinikum Magdeburg A.o.R. ( Site 0516)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 1006)

location_facility: University of Tsukuba Hospital ( Site 1503)

location_facility: Central Texas Veterans Healthcare System ( Site 0057)

location_facility: National Cancer Center Hospital East ( Site 1504)

location_facility: Princess Margaret Cancer Centre ( Site 0107)

location_facility: Bayandin Murmansk Regional Clinical Hospital ( Site 0859)

location_facility: Kyiv City Clinical Oncology Center ( Site 0960)

location_facility: Regional Oncological Hospital ( Site 0956)

location_facility: Seoul National University Bundang Hospital ( Site 1356)

location_facility: Southside Cancer Care Centre ( Site 1252)

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0906)

location_facility: Kent and Canterbury Hospital ( Site 0709)

location_facility: Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0512)

location_facility: Universitaetsklinikum Erlangen ( Site 0505)

location_facility: Azienda Ospedaliera San Camillo Forlanini ( Site 0560)

location_facility: UMass Memorial Medical Center ( Site 0051)

location_facility: Centre Armoricain de Radiotherapie Imagerie medicale et Oncologie ( Site 0457)

location_facility: The Royal Marsden Foundation Trust ( Site 0702)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 1012)

location_facility: SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 1010)

location_facility: Charleston Area Medical Center ( Site 0023)

location_facility: Instituto Nacional de Cancerologia ( Site 0256)

location_facility: Hacettepe Universitesi Tıp Fakultesi ( Site 0911)

location_facility: Volga District Medical Center Federal Medical and Biological Agency ( Site 0857)

location_facility: New York University Perlmutter Cancer Center ( Site 0008)

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1062)

location_facility: Lviv Regional Clinical Hospital ( Site 0955)

location_facility: Hirosaki University Hospital ( Site 1502)

location_facility: Nova Scotia Health Authority ( Site 0109)

location_facility: Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0866)

location_facility: Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 1001)

location_facility: Hospital Universitario Ramon y Cajal ( Site 0660)

location_facility: Istituto Nazionale Studio e Cura dei Tumori ( Site 0551)

location_facility: Sakarya Universitesi Tip Fakultesi ( Site 0913)

location_facility: Saitama Medical University International Medical Center ( Site 1505)

location_facility: Maharaj Nakorn Chiangmai Hospital ( Site 1453)

location_facility: Indiana University Melvin and Bren Simon Cancer Center ( Site 0004)

location_facility: Charite Universitaetsmedizin Berlin ( Site 0515)

location_facility: Leningrad Regional Oncology Center ( Site 0868)

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0909)

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1007)

location_facility: Centro Estatal de Cancerologia de Chihuahua ( Site 0253)

location_facility: H. de Gerona Dr. Josep Trueta ( Site 0651)

location_facility: MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 0963)

location_facility: Peninsula Health Frankston Hospital ( Site 1258)

location_facility: Kursk Regional Clinical Oncology Dispensary ( Site 0854)

location_facility: Nara Medical University Hospital ( Site 1510)

location_facility: FSBI ""United Hospital with Polyclinic"" of the Administrative Department of the President of the Ru

location_facility: Shaare Zedek Medical Center ( Site 0809)

location_facility: Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 0254)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0861)

location_facility: AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0005)

location_facility: Hospital Universitario La Paz ( Site 0661)

location_facility: Ivanovo Regional Oncology Dispensary ( Site 0852)

location_facility: Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. ( Site 0300)

location_facility: Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1060)

location_facility: Rigshospitalet University Hospital ( Site 0401)

location_facility: Luxmed Onkologia sp. z o. o. ( Site 1051)

location_facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0105)

location_facility: Sapporo Medical University Hospital ( Site 1501)

location_facility: Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0967)

location_facility: Hiroshima City Hiroshima Citizens Hospital ( Site 1513)

location_facility: CHU UCL Namur Site de Godinne ( Site 0354)

location_facility: University Hospitals Cleveland Medical Center ( Site 0038)

location_facility: Tokyo Medical and Dental University Hospital ( Site 1517)

location_facility: Hospital Universitario Quiron Madrid ( Site 0657)

location_facility: A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico ( Site 0559)

location_facility: CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0111)

location_facility: Universitaetsklinikum Carl Gustav Carus ( Site 0519)

location_facility: Herlev og Gentofte Hospital. ( Site 0402)

title: A Phase 3, Randomized, Double-blind Study to Evaluate Perioperative Pembrolizumab (MK-3475) + Neoadjuvant Chemotherapy Versus Perioperative Placebo + Neoadjuvant Chemotherapy in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-866)

summary: A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients.


design_allocation: Randomized

intervention_type: Other

status: Recruiting

study_start_date_type: Actual

study_type: Interventional

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

lead_sponsor: AstraZeneca

enrollment_type: Anticipated

primary_purpose: Treatment

location_country:
Peru
Australia
Russian Federation
Taiwan
India
France
Japan
Poland
Thailand
Canada
Korea, Republic of
Hong Kong
Vietnam
Philippines
Singapore
Puerto Rico
China
United States
Germany
Italy
Austria
Brazil
Egypt
Turkey

ipd_sharing: Yes

study_completion_date_type: Anticipated

type: EudraCT Number

source: euctr

title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi Center Study of Durvalumab Monotherapy or in Combination With Bevacizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation

summary: A global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab alone in patients with hepatocellular carcinoma who are at high risk of recurrence.

lead_sponsor_type: industriel

status_simplified: Ongoing


title: An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

summary: The main objective is to assess long term tolerability and safety of treatment with oral nintedanib in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who have complete (and did not prematurely discontinue trial medication in) the phase III parent trial, INBUILD® (trial 1199.247).

status: Active, not recruiting

enrollment_type: Actual

ipd_sharing_description:
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

lead_sponsor: Boehringer Ingelheim

location_country:
Italy
United States
Chile
Spain
Germany
France
Japan
Poland
Belgium
Argentina
Russian Federation
China
Canada
United Kingdom
Korea, Republic of

location_facility: The First Hospital of Chinese Medical University

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: University of Florida College of Medicine

location_facility: Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

location_facility: Norbert Barlicki University Clinical Hospital No.1, Lodz

location_facility: Leszek Giec Upper-Silesian Med.Cent.Silesian Med.Univ.

location_facility: NewYork-Presbyterian/Weill Cornell Medical Center

location_facility: Instituto Médico de la Fundación Estudios Clínicos

location_facility: University of Utah Health Sciences Center

location_facility: Clinical Hospital No. 1, n.a. Prof. Szyszko from Silesian MA

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Seoul National University Bundang Hospital

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

location_facility: National Hospital Organization Himeji Medical Center

location_facility: Azienda Ospedaliera Policlinico di Modena

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente"

location_facility: Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Central Scientific Research Insitute of Tuberculosis

location_facility: Kobe City Medical Center General Hospital

location_facility: Pulmonary and Critical Care Associates of Baltimore

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Moscow 1st State Med.Univ.n.a.I.M.Sechenov

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Tokyo Medical and Dental University Hospital

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

location_facility: Emergency Clinical Hospital n. a. N. V. Solovyev, Yaroslavl

location_facility: CEMER-Centro Medico De Enfermedades Respiratorias

location_facility: Columbia University Medical Center-New York Presbyterian Hospital

location_facility: University of Texas Southwestern Medical Center

intervention_type: Drug


type: Other Identifier

type: Registry Identifier

title: Effect of Semaglutide Versus Placebo on the Progression of Renal Impairment in Subjects With Type 2 Diabetes and Chronic Kidney Disease

acronym: FLOW

summary: The researchers are doing this study to see if semaglutide can slow down the growth and worsening of chronic kidney disease in people with type 2 diabetes. Participants will get semaglutide (active medicine) or placebo ('dummy medicine'). This is known as participants' study medicine - which treatment participants get is decided by chance. Semaglutide is a medicine, doctors can prescribe in some countries for the treatment of type 2 diabetes. Participants will get the study medicine in a pen. Participants will use the pen to inject the medicine in a skin fold once a week. The study will close when there is enough information collected to show clear result of the study. The total time participants will be in this study is about 3 to 5 years, but it could be longer.

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

lead_sponsor: Novo Nordisk A/S

location_country:
Malaysia
Greece
Belgium
Australia
Russian Federation
Ukraine
India
France
Japan
Poland
Slovakia
Thailand
Argentina
Canada
South Africa
Netherlands
Bulgaria
Hungary
China
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Israel
Spain
Turkey


title: A Randomized Double-blind Placebo-controlled Multicenter Phase 3 Study of Efficacy and Safety of AR-301 as Adjunct Therapy to Antibiotics in the Treatment of Ventilator-Associated Pneumonia (VAP) Caused by S. Aureus

summary: AR-301 is being evaluated as an adjunctive treatment of ventilator-associated pneumonia (VAP) due to Staphylococcus aureus (S. aureus) in combination with standard of care (SOC) antibiotic therapy in patients with confirmed S. aureus infection.

status: Unknown status

ipd_sharing: No

lead_sponsor: Aridis Pharmaceuticals, Inc.

location_country:
Brazil
South Africa
India
Serbia
Mexico
France
Israel
Georgia
Belgium
Russian Federation
Belarus
Estonia
United States
Latvia
Turkey
Ukraine

location_facility: CHRU de Lille-Urgence Respiratoire et Réanimation Médicale

location_facility: Hospital Civil de Guadalajara "Fray Antonio Alcalde"

location_facility: Health Institution Vitebsk City Clinical Emergency Hospital

location_facility: Railway Clinical Hospital of JSC Russian Railways

location_facility: I.I. Dzhanelidze Research Institute of Emergency Medicine

location_facility: Clinical-Hospital Centre Bezanijska Kosa - Pulmonology Department

location_facility: Ltd Archangel St. Michael Multiprofile Clinical Hospital

location_facility: CHRU de Tours - Hopital Bretonneau- Médecine Intensive et Réanimation

location_facility: Clinical Center of Serbia_Emergency Center

location_facility: Ltd Academician O.Gudushauri National Medical Center

location_facility: Riga East Clinical University Hospital Clinic "Gailezers"

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: Ltd Academician Z. Tskhakaia West Georgian National Center of Interventional Medicine

location_facility: Regional Communal Establishment "Emergency Medicine Hospital"

location_facility: Kharkiv City Clinical Hospital No 2 n.a. prof. O.O.Shalimov

location_facility: State Institution Institute of General and Emergency Surgery named after V.T. Zaitsev of the National Academy of Medical Sciences of Ukraine

location_facility: Tartu University Hospital Intensive Care Department

location_facility: Railway Clinical Hospital on Station Chelyabinsk of JSC Russian Railways

location_facility: Clinical Center of Serbia_Clinic for Digestive Surgery

location_facility: Riga East Clinical University Hospital Clinic "Bikernieki"

location_facility: Republic Scientific and Practical Center of Pulmonology and Tuberculosis

location_facility: CHD Vendee-Service de Médecine Intensive-Réanimation

location_facility: Centro de Estudos Clínicos do Interior Paulista - CECIP

location_facility: Faculdade de Medicina de S. J. Do Rio Preto (FAMERP)- Hospital de Base de São José do Rio Preto

location_facility: Hospital e Maternidade Celso Pierro-PUC-Campinas

location_facility: Health Institution Mogilev Regional anti-Tuberculosis Dispensary

location_facility: Hadassah Medical Center Kiryiat Hadassah

location_facility: Hospices Civils de Lyon - Hôpital Pierre Wertheimer Service Anesthésie/Réanimation

location_facility: CHU UCL Namur - site Mont-Godinne - Soins Intensifs

location_facility: linical Center Kragujevac Center for Anaesthesiology and Reanimation

location_facility: Istanbul Medipol Universitesi Tıp Fakultesi Hastanesi

location_facility: СHRU de Nîmes -Hôpital Carémeau-Service des Réanimations

location_facility: CHU de Rennes-Pavillon Clémenceau-Hôpital Pontchaillou

location_facility: KLES Dr. Prabhakar Kore Hospital& Medical Research centre

location_facility: CHU de Nantes, Service de Réanimation Chirurgicale Polyvalente

location_facility: Ltd Academician Vakhtang Bochorishvili clinic

location_facility: State Institution V.T. Zaitsev institute of General and Emergency Surgery of National Academy of Medical Sciences of Ukraine

location_facility: Institute of Pulmonary Diseases of Vojvodina

status_simplified: Unknown


ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

location_country:
Italy
Brazil
United States
India
Hong Kong
Mexico
Spain
Vietnam
France
Japan
Thailand
Singapore
Australia
Russian Federation
China
Canada
Korea, Republic of
Taiwan

title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Transarterial Chemoembolization (TACE) in Combination With Either Durvalumab Monotherapy or Durvalumab Plus Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma (EMERALD-1)

summary: A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma


status: Completed

lead_sponsor: Egetis Therapeutics

primary_purpose: Prevention

location_country:
Italy
United States
Hong Kong
France
Czechia
Japan
Hungary
Belgium
Spain
Germany
United Kingdom
Korea, Republic of
Taiwan

acronym: POLAR-M

location_facility: Centre Hospitalier Départemental de Vendée - Unité de recherche clinique

location_facility: Hôpital Nord Franche-Comté Site du Mittan

location_facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelőintézet

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház

location_facility: KMUH: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Mid Florida Hematology and Oncology Center

location_facility: Azienda Ospedaliero - Universitaria di Modena Policlinico

location_facility: Chonnam National University Hwasun Hospital

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Scott & White Vasicek Cancer Treatment Center

location_facility: Seoul National University Bundang Hospital

location_facility: NCKUH: National Cheng Kung University Hospital

location_facility: St. Marianna University School of Medicine Hospital

study_completion_date_type: Actual

title: A Phase 3, Double-blind, Multicenter, Placebo-controlled Study of PledOx Used on Top of Modified FOLFOX6 (5-FU/FA and Oxaliplatin) to Prevent Chemotherapy Induced Peripheral Neuropathy (CIPN) in Patients With First-line mCRC

summary: This study evaluates the investigational drug PledOx in the prevention of chronic chemotherapy induced peripheral neuropathy (CIPN) induced by the drug oxaliplatin.

status_simplified: Completed


title: A Phase I/II Study of Paclitaxel Plus Carboplatin and Durvalumab (MEDI4736) With or Without Oleclumab (MEDI9447) for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer

acronym: SYNERGY

summary:
The combination of chemotherapy with PD-1 immune checkpoint blockade agents demonstrated promising results especially in the neo-adjuvant and early metastatic setting in TNBC. However, a substantial proportion of patients do not derive benefit from this approach.

CD73 is an adenosine-generating enzyme overexpressed in several cancers and associated with poor prognosis and reduced anti-tumor immunity in TNBC. Monoclonal antibodies directed against CD73 could help to reprogram the tumor microenvironement by decreasing the adenosine mediated immunosuppression, particularly as a synergistic immunotherapeutic combination with immune checkpoint blockade.

The SYNERGY trial investigates the role of an anti-CD73 (MEDI9447) in a randomized phase II trial evaluating the efficacy and safety of the combination of chemotherapy (paclitaxel + carboplatin) with immunotherapy (durvalumab [anti-PD-L1] +/- MEDI9447 [anti-CD73]) in previously untreated locally recurrent inoperable or metastatic TNBC.

A large translational research program is planned including baseline and dynamic biomarkers

lead_sponsor: Jules Bordet Institute

location_country: Belgium France

location_facility: Institut Régional du Cancer de Montpellier


lead_sponsor: Bristol-Myers Squibb

location_country:
Romania
Belgium
Australia
Russian Federation
Denmark
Taiwan
Ukraine
Croatia
France
Japan
Poland
Slovakia
Canada
Korea, Republic of
Sweden
Switzerland
Netherlands
Hungary
Ireland
China
Portugal
United States
Germany
United Kingdom
Italy
Brazil
Mexico
Czechia
Israel
Spain

acronym: LATTICE

location_facility: Fondazione Policlinico Universitario Agostino Gemelli - Presidio Columbus

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Jadwiga Miecz

location_facility: Centrum Medyczne Szpital Swietej Rodziny

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Spring Gastroenterology Associates - Houston

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: University of Mississippi Medical Center

location_facility: Republican Clinical Hospital Ministry of Health Republic of Tatarstan

location_facility: National Hospital Organization Sendai Medical Center

location_facility: National Hospital Organization Kyoto Medical Center

location_facility: South Edmonton Gastroenterology Research Clinic

location_facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

location_facility: Centre Hospitalier Universitaire de Saint-Etienne - Hopital Nord

location_facility: University of Iowa Hospitals and Clinics

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Hunter Holmes McGuire Veterans Administration Medical Center

location_facility: New York-Presbyterian Columbia University Medical Center

location_facility: Florida Medical Clinic - Clinical Research Division

location_facility: Faculdade de Medicina de Sao Jose do Rio Preto Hospital de Base

location_facility: National Hospital Organization Hirosaki National Hospital

location_facility: Eurolatino Juiz de Fora Pesquisas Medicas

location_facility: Vanderbilt Inflammatory Bowel Disease Clinic

location_facility: Digestive Disease Specialists - Ambulatory Endoscopy Center - North

location_facility: Semmelweis Egyetem I.sz. Belgyogyaszati Klinika

location_facility: Gastroenterology Associates of Western Michigan

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico SantOrsola-Malpighi

location_facility: ASST Santi Paolo e Carlo - Ospedale San Paolo Polo Universitario

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: H-T. Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia

location_facility: Hospital da Senhora da Oliveira - Guimaraes

location_facility: Kaiser Permanente Colorado Institute for Health Research

location_facility: Centro Hospitalar de Entre o Douro e Vouga

location_facility: Shiga University of Medical Science Hospital

location_facility: Desarrollo Etico en Investigacion Clinica

location_facility: Indiana University Health University Hospital

location_facility: Centro Multidisciplinar de Estudos Clinicos

location_facility: Gastroenterology Research of San Antonio

location_facility: Clinical Research of West Florida - Tampa

location_facility: Multidisciplinary Consultative and Diagnostic Center

location_facility: Advanced Research Institute - New Port Richey

location_facility: Blackpool Teaching Hospitals NHS Foundation Trust

location_facility: New York Langone Long Island Clinical Research Associates

location_facility: Istituto Clinico Humanitas Humanitas Cancer Center

location_facility: Centre Hospitalier Universitaire Universite Catholique de Louvain Site Godinne

location_facility: Saint Petersburg State Budgetary Institution of Health City Hospital of the Holy Martyr Elizabeth

location_facility: Azienda Ospedaliero-Universitaria Mater Domini

location_facility: Abertawe Bro Morgannwg University Health Board

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

location_facility: Vancouver Coastal Health Research Institute

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel

location_facility: Hospital Universitari de Girona Doctor Josep Trueta

location_facility: Southern Star Research Institute - Medical Center Office

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Gastroenterologische Gemeinschaftspraxis am Germania Campus

location_facility: Hospital General Universitario de Alicante

location_facility: Digestive Health Associates of Texas - Richardson

location_facility: Centro de Investigacion en Gastroenterologia

location_facility: Intesto Gastroenterologische Praxis & Crohn-Colitis-Zentrum Bern

location_facility: Azienda Ospedaliero Universitaria di Cagliari - Monserrato

location_facility: The Medical Research Center of Connecticut

location_facility: University of Florida Health - Jacksonville

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil

location_facility: Clinica Medica Azienda Ospedaliera Universitaria

location_facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie

location_facility: Hospital Universitario Clementino Fraga Filho

location_facility: SER - Servicos Especializados em Reumatologia da Bahia

location_facility: Warrington and Halton Hospitals NHS Foundation Trust

location_facility: University of Miami Miller School of Medicine

location_facility: Penn State Health Milton S. Hershey Medical Center

location_facility: Szegedi Tudomanyegyetem - Altalanos Orvostudomanyi Kar

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Novosibirsk State Regional Clinical Hospital

location_facility: Uniwersytecki Szpital Kliniczny Number 1 im. Norberta Barlickiego

location_facility: Hospital das Clinicas da Faculdade de Medicina de Botucatu

location_facility: Donald Guthrie Foundation for Education and Research

location_facility: Polo Universitario - LAzienda Ospedaliera Luigi Sacco

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz

title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Crohn's Disease

summary: The purpose of this study is to assess the safety and effectiveness of BMS-986165 compared to placebo in participants with moderately to severely active Crohn's Disease.


lead_sponsor: Eisai Inc.

location_country:
Australia
Russian Federation
Taiwan
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Colombia
Ireland
United States
Germany
United Kingdom
Italy
Brazil
Mexico
Israel
New Zealand
Spain
Turkey

location_facility: Pomorski Uniwersytet Medyczny w Szczecinie

location_facility: Investigacion Onco Farmaceutica S de RL de CV

location_facility: Szpital Kliniczny im Ks Anny Mazowieckiej

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

location_facility: Florence Nightingale Gayrettepe Hastanesi

location_facility: SPb SBHI City Clinical Oncological Dispensary

location_facility: Azienda Ospedaliera per l Emergenza Cannizzaro

location_facility: Centro de Oncologia e Investigacion Buenos Aires COIBA

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Fundacion Colombiana de Cancerologia Clinica Vida

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: Hospital General Universitari Vall d Hebron

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM

location_facility: Kaohsiung Chang Gung Memorial Hospital of the C.G.M.F.

location_facility: Institut Regional du Cancer de Montpellier - ICM

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Georgia Cancer Center at Augusta University

location_facility: Basken Adana Dr.Turgut Noyan Uygulama ve Arastirma Merkezi

location_facility: Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Hospital Universitario y Politecnico La Fe de Valencia

location_facility: FSBI National Medical Oncology Research Center n.a. N.N. Blokhina

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Alivia Clinica de Alta Especialidad S.A. de C.V.

location_facility: Clinica Colsanitas S.A. - Sede Clinica Universitaria Colombia

location_facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont

location_facility: John Theurer Cancer Center at Hackensack University Med Ctr

location_facility: Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals

location_facility: Centre de Lutte Contre le Cancer Francois Baclesse

location_facility: Tomsk National Research Medical Center of Russian Academy of Sciences

location_facility: Instituto do Cancer de Sao Paulo - ICESP

location_facility: Mordovia Republican Oncological Dispensary

location_facility: Faculdade de Medicina da Universidade Federal de Minas Gerais

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: Groupe Hospitalier Broca Cochin Hotel Dieu

location_facility: Szpital Morski im. PCK Szpitale Wojewodzkie w Gdyni Sp. z o.o.

location_facility: Texas Oncology-San Antonio Medical Center

location_facility: Centre Armoricain de Radiotherapie Imagerie medicale et Oncologie

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH

location_facility: Barts Health NHS Trust - St Bartholomew s Hospital

location_facility: Instituto de Investigaciones Metabolicas

location_facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs

location_facility: Centrum Onkologii. Instytut im. Marii Sklodowskiej-Curie

location_facility: FSBI-FRCC of Special Types Med. Care & Technologies FMBA of Russia

location_facility: CHU de Quebec-Universite Laval-Hotel Dieu de Quebec

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej Curie

location_facility: Beskidzkie Centrum Onkologii im. Jana Pawla II

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Chang Gung Medical Foundation. Linkou Branch

title: A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer

summary: This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib (E7080) versus treatment of physician's choice (doxorubicin or paclitaxel) for the treatment of advanced endometrial cancer. Participants will be randomly assigned to receive either pembrolizumab and lenvatinib or treatment of physician's choice. The primary study hypothesis is that pembrolizumab in combination with lenvatinib prolongs progression free survival (PFS) and overall survival (OS) when compared to treatment of physician's choice.


title: A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients With Primary FSGS

acronym: DUPLEX

summary: To determine the long-term nephroprotective potential of treatment with sparsentan as compared to an angiotensin receptor blocker in patients with primary and genetic focal segmental glomerulosclerosis (FSGS).

lead_sponsor: Travere Therapeutics, Inc.

location_country:
Belgium
Australia
Denmark
Taiwan
Croatia
France
Poland
Argentina
Canada
Korea, Republic of
Sweden
Hong Kong
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Czechia
New Zealand
Spain
Estonia


title: A Two-Year, Two-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients With Visual Impairment Due to Diabetic Macular Edema

acronym: KITE

summary: The purpose of this study is to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular edema (DME).

ipd_sharing: Undecided

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Malaysia
Belgium
Russian Federation
Denmark
Taiwan
India
France
Poland
Lithuania
Slovakia
Norway
Korea, Republic of
Turkey
Sweden
Switzerland
Bulgaria
Singapore
Hungary
Germany
Lebanon
Czechia
Estonia
Latvia


title: A Randomized Phase 3 Comparison of IMO-2125 With Ipilimumab Versus Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma (ILLUMINATE-301)

summary: A Phase 3 comparison of ipilimumab with and without IMO-2125 in advanced melanoma

status: Terminated

lead_sponsor: Idera Pharmaceuticals, Inc.

location_country:
Italy
United States
Sweden
Netherlands
Germany
France
Czechia
Australia
Spain
Canada
United Kingdom

location_facility: Alberta Health Services Cross Cancer Institute

location_facility: Medizinische Hochschule Hannover - Klinik for Dermatologie, Allergologie und Venerologie

location_facility: University of Florida Health Cancer Center - Orlando Health

location_facility: University of Alabama at Birmingham (UAB)

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

location_facility: Mount Sinai Medical Center of Florida, Inc.

location_facility: Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari

location_facility: The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James)

location_facility: Fakultni nemocnice Olomouc - Oncology clinic

location_facility: Azienda Ospedaliero Universitaria Senese

location_facility: Istituto Nazionale di Tumori IRCCS "Fondazione Sen. G. Pascale"

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Hospital Universitari Quiron Dexeus Barcelona

location_facility: Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie, Universität Würzburg

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino IST

location_facility: Fondazione Policlinico Universitario A. Gemelli - Universita Cattolica del Sacro Cuore

location_facility: Consorci Hospital General Universitari de Valencia

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Azienda Ospedaliero-Universitaria di Modena

location_facility: Cancer Treatment Centers of America (CTCA) - Western Regional Medical Center

location_facility: University of California, San Diego (UCSD) - Moores Cancer Center

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: University of California, Los Angeles (UCLA)


title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of Gantenerumab in Patients With Early (Prodromal to Mild) Alzheimer's Disease

summary: This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of gantenerumab versus placebo in participants with early (prodromal to mild) AD. All participants must show evidence of beta-amyloid pathology. Eligible participants will be randomized 1:1 to receive either subcutaneous (SC) injection of gantenerumab or placebo. The primary efficacy assessment will be performed at the end of the double blind period at week 116. Participants will then be offered to enter into an open-label extension (OLE). Participants not willing to go to the OLE will participate in a long term follow-up period for up to 50 weeks after the last gantenerumab dose.

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

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Brazil
United States
Peru
Spain
Germany
France
Japan
Lithuania
Hungary
Australia
Russian Federation
China
Canada
Taiwan
Colombia

location_facility: PANAKEIA - Arzneimittelforschung Leipzig GmbH

location_facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine

location_facility: China Medical University Hospital; Neurology

location_facility: Ambulates Gesundheitszentrum der Charité GmbH; MVZ Neurologie Campus Benjamin Franklin

location_facility: UVaMID Hospital Santa Caterina;; Servicio de Neurología

location_facility: Huashan Hospital Affiliated to Fudan University

location_facility: NeuroCentrum Odenwald; Dres. Reifschneider, Unsorg, Ries, Schumann, Hoffmann, Knoblich

location_facility: Hospital Vall d'Hebron; Servicio de Neurología

location_facility: The Second Affiliated Hospital, Zhejiang University

location_facility: Josephson Wallack Munshower Neurology PC

location_facility: Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: Groupement Hospitalier Est - Hôpital Neurologique; Neurologie A (U502)

location_facility: University of Mississippi Medical Center

location_facility: Hospital Ruber Internacional; Servicio de Neurología

location_facility: Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie

location_facility: City Psychiatric Hospital #3 of Skvortsov-Stepanov

location_facility: Universitätsklinikum Hamburg-Eppendorf Zentrum f.Psychosoz.Medizin Klinik f.Psychiatrie

location_facility: IRCCS Ospedale San Raffaele; Centro Disturbi della Memoria

location_facility: SBHI SR Region Specialized Psychiatric Hospital #2

location_facility: Guangdong Provincial People's Hospital; Breast

location_facility: Chang Gung Memorial Foundation - Linkou - Neurology

location_facility: Hospital Universitari de Bellvitge; Servicio de Neurologia

location_facility: Policlinico Universitario Agostino Gemelli; UOC Neurologia

location_facility: The Second Affiliated Hospital to Nanchang University

location_facility: Tianjin Medical University General Hospital

location_facility: California Neuroscience Research Medical Group, Inc

location_facility: Hôpital Avicenne; Centre de Recherche Clinique

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Neurología

location_facility: Global Medical Institues, LLC; Central Miami Medical Institute

location_facility: Central Clinical Hospital #2 N.A. Semashko OAO RJHD

location_facility: Ospedale San Giovanni Calibita Fatebenefratell;Neurologia

location_facility: Casa di Cura Policlinico; Dipartimento di Scienze Neuroriabilitative

location_facility: The First Affiliated Hospital of Wenzhou Medical College

location_facility: St. Josef-Hospital, Klinik für Neurologie

location_facility: Hospital Universitario Reina Sofia; Servicio de Neurologia

location_facility: Zhongda Hospital Affiliated to Southeast University

location_facility: Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

location_facility: Center for Diagnosis and Research on Alzheimer's disease

location_facility: Alzheimer's Research and Treatment Center

location_facility: NHO Shizuoka Institute of Epilepsy and Neurological Disorders

location_facility: Hospital Nacional Cayetano Heredia; Servicio de Neurologia

location_facility: Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría

location_facility: City Clinical Hospital # 2 n.a. V.I. Razumovsky

location_facility: Hospital Nossa Senhora das Graças; Setor de Pesquisa em Neurologia

location_facility: Hospital Universitari Quiron Dexeus;; Servicio Neurología

location_facility: ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic

location_facility: Australian Alzheimer's Research Foundation

location_facility: National Hospital Organization Chiba-East Hospital

location_facility: National Clinical Research Inc.-Richmond

location_facility: Universidade Federal de Sao Paulo - UNIFES

location_facility: Servicio de Neurología Hospital Viamed Montecanal.

location_facility: Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre

location_facility: Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion

location_facility: Sun Yat-sen Memorial Hospital; Neurology

location_facility: Tangdu Hospital, The Fourth Military Medical University; Neurology Department

location_facility: Neurology Specialists of Monmouth County, PA

location_facility: Umberto I Policlinico di Roma-Università di Roma La Sapienza

location_facility: The Medical Arts Health Research Group - West Vancouver

location_facility: Centro de Investigaciones y Proyectos en Neurociencias CIPNA

location_facility: Oregon Center for Clinical Investigations, Inc

location_facility: Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie

location_facility: Semmelweis University; Department of Neurology

location_facility: Universitätsklinikum des Saarlandes Klinik f. Psychiatrie und Psychotherapie

location_facility: Medical Corporation Hakuyokai Kashiwado Hospital

location_facility: Institute Universitaire de Geriatrie de Montreal

location_facility: Beijing Tian Tan Hospital,Capital Medical University

location_facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: Research Center for Clinical Studies, Inc.

location_facility: AO Città della Salute e della Scienza Osp.S.Giov.Battista Molinette; SC Geriatria

location_facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

location_facility: Neurological Associates of Long Island, PC

location_facility: Guangzhou First Municipal People's Hospital

location_facility: Universitätsmedizin derJohannes Gutenberg-Universität Mainz;Klinik für Psychiatrie und Psychotherapi

location_facility: University of California, Davis; Alzheimers Disease Center, Department of Neurology

location_facility: Hospital das Clinicas - FMUSP_X; Neurologia

location_facility: IRCCS "Centro S. Giovanni di Dio" Fatebenefratelli -UO Alzheimer

location_facility: Vilnius University Hospital Santariskiu Clinics; Neurology

location_facility: State Autonomous Healthcare Institution "Republican Clinical Neurological Center

location_facility: Hospital Ramon y Cajal; Servicio de Neurologia

location_facility: Universitätsklinikum Köln; Klinik und Poliklinik für Psychiatrie und Psychotherapie

location_facility: Universitätsklinikum Rostock Zentrum für Nervenheilkunde

location_facility: Dipartimento delle Patologie Emergenti; Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

location_facility: Gerontopole; Centre de Recherche clinique

location_facility: Taipei Veterans General Hospital-Neurology

location_facility: Hospital Clinic i Provincial; Servicio de Neurologia

location_facility: Hospital General De Catalunya; Servicio de Neurologia

location_facility: Universitätsklinikum Essen, Elisabeth-Krankenhaus, Klinik für Geriatrie, Haus Berge, Contilia GmbH

location_facility: Hospital General Universitario de Albacete; Servicio de Neurología

location_facility: Chang Gung Memorial Foundation - Kaohsiung - Neurology

location_facility: Kaohsiung Medical University Hospital; Neurology

location_facility: Hospital San Pedro; Servicio de Neurología

location_facility: Advanced Memory Research Institute of NJ

location_facility: Russian Medical Military Academy n.a. S.M.Kirov; Neurology Department

location_facility: IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA

location_facility: Tokyo Bay Advanced Medical and Makuhari Clinic

location_facility: HM Universitario Puerta del Sur CINAC (C.Integ.Neuroc);; Servicio de Psiquiatría

location_facility: Universitätsklinikum Ulm; Klinik für Neurologie

location_facility: Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz

location_facility: Ente Ospedaliero Ospedali Galliera; Ambulatorio di Neurologia

location_facility: FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency

location_facility: Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

location_facility: HammondCare Aged Psychiatry Clinical Trials

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: Hospital Virgen del Rocío; Servicio de Neurología

location_facility: Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie

location_facility: State autonomous institution of healthcare Inter-regional clinical and diagnostic center

location_facility: Neurology Consultants of Dallas; Research Department

location_facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia

location_facility: Center for Advanced Research & Education

location_facility: Clinica Internacional; Unidad De Investigacion

location_facility: Oregon Health and Science University, Layton Aging and Alzheimer's Disease Center

location_facility: Universitätsklinikum Düsseldorf; Klinik für Neurologie

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia

location_facility: National Center of Neurology and Psychiatry

location_facility: Fondazione Santa Lucia IRCCS; Neurologia e Riabilitazione Neurologica

location_facility: CHU de la Timone - Hopital d Adultes; Service de Neurologie

location_facility: Fujian Medical University Union Hospital

location_facility: Hospital Universitario Dr. Peset; Servicio de Neurologia

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia

location_facility: National Taiwan University Hospital; Neurology

location_facility: Ohio State University; College of Medicine

location_facility: Southern Illinois University, School of Medicine

location_facility: Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica - Dipartimento di Neuroscienze


title: A Phase 2 Placebo-Controlled, Double-Blind, Enriched Enrollment Randomized Withdrawal Study to Evaluate the Efficacy and Safety of BIIB074 (Vixotrigine) in Treating Pain Experienced by Subjects With Confirmed Small Fiber Neuropathy That is Idiopathic or Associated With Diabetes Mellitus

summary:
The primary objective of this study is to evaluate the efficacy of BIIB074 in treating pain experienced by participants with confirmed small fiber neuropathy (SFN) that is idiopathic or associated with diabetes mellitus. A secondary endpoint that relates to the primary objective is the change from Randomization to Week 12 of the double-blind period in mean average daily pain score.

The secondary objectives of this study are to evaluate the effect on worst pain, neuropathic pain quality, sleep interference due to pain, patient global impression, use of rescue medication, and SFN symptoms in participants treated with BIIB074; to investigate the safety and tolerability of BIIB074 in participants with SFN; and to characterize the pharmacokinetics (PK) of BIIB074 in participants with SFN.

lead_sponsor: Biogen

location_country:
Italy
Switzerland
Netherlands
Germany
France
Czechia
Bulgaria
Greece
Poland
Hungary
Spain
Denmark
Canada
United Kingdom

location_facility: Hôpital Ambroise Paré - Boulogne-Billancourt

location_facility: Nemocnice Pardubickeho kraje a.s. Pardubicka nemocnice

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Groupement Hospitalier Sud - Hôpital Bicêtre

location_facility: Hospital General Universitario de Alicante

location_facility: Azienda Ospedaliero Univeraitaria Pisana

location_facility: CHU Clermond Ferrand - Hopital Gabriel Montpied

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: CHUV - Centre Hospitalier Universitaire Vaudois

location_facility: Hausarzt- und Diabetologische Schwerpunktpraxis

location_facility: Regionalna Poradnia Diabetologiczna Zytkiewicz-Jaruga,Stasinska

location_facility: Gemeinschaftspraxis Diabeteszentrum Dortmund Dr.med. Klaus Busch

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz


title: A Phase 3 Randomized, Open-label, Multicenter Study Assessing the Clinical Benefit of Isatuximab (SAR650984) in Combination With Bortezomib (Velcade®), Lenalidomide (Revlimid®) and Dexamethasone Versus Bortezomib, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma (NDMM) Not Eligible for Transplant

acronym: IMROZ

summary:
Primary Objective:

To demonstrate the benefit of isatuximab (I) in combination with bortezomib (V), lenalidomide (R) and dexamethasone (d) in the prolongation of progression free survival (PFS) as compared with bortezomib, lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma (NDMM) not eligible for transplant.

Secondary Objectives:

To evaluate in both randomized arms: very good partial response (VGPR) or better rate as defined by the International Myeloma Working Group (IMWG) criteria, minimal residual disease (MRD) negativity rate in patients with complete response (CR) or VGPR, CR rate per IMWG criteria, time to progression (TTP) and overall by MRD status, PFS in MRD negative patients, duration of response (DOR) and overall by MRD status, time to first response (TT1R), time to best response (TTBR), PFS on next line of therapy (PFS2), overall survival (OS), overall response rate (ORR) per IMWG criteria (including crossover arm), safety (including crossover arm), and to assess disease-specific and generic health-related quality of life (HRQL)
To determine the pharmacokinetic (PK) profile of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone (excluding crossover arm)
To evaluate the immunogenicity of isatuximab in patients receiving isatuximab (including crossover arm)

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

lead_sponsor: Sanofi

location_country:
Greece
Belgium
Australia
Russian Federation
Denmark
Taiwan
France
Japan
Lithuania
Poland
Sweden
China
Portugal
Germany
United States
Italy
Mexico
Czechia
New Zealand
Spain
Turkey

location_facility:
Investigational Site Number :1560006
Investigational Site Number :3800003
Investigational Site Number :7240001
Investigational Site Number :2500012
Investigational Site Number :3920008
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Investigational Site Number :0360002
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Investigational Site Number :6160004
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Investigational Site Number :0360005
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Investigational Site Number :3920005
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Investigational Site Number :6430001
Investigational Site Number :1560002
Investigational Site Number :0360003
Investigational Site Number :1580002
Investigational Site Number :2500007
Investigational Site Number :2080004
Investigational Site Number :4840001
Investigational Site Number :5540001
Investigational Site Number :7520001
Investigational Site Number :2030006
Investigational Site Number :6200005
Investigational Site Number :2500004
Investigational Site Number :1560009
Investigational Site Number :2030003
Investigational Site Number :2080002
Investigational Site Number :1560001
Investigational Site Number :1560003
Investigational Site Number :1560011
Investigational Site Number :6200001
Investigational Site Number :2030004
Investigational Site Number :2760001
Investigational Site Number :6160003
Investigational Site Number :7920004
Investigational Site Number :8400005
Investigational Site Number :2760004
Investigational Site Number :6200003
Investigational Site Number :3920003
Investigational Site Number :3800002
Investigational Site Number :3000003
Investigational Site Number :3920010
Investigational Site Number :8400007
Investigational Site Number :0560001
Investigational Site Number :2500005
Investigational Site Number :7920008
Investigational Site Number :0360006
Investigational Site Number :2500001
Investigational Site Number :7240004
Investigational Site Number :2760005
Investigational Site Number :7520002
Investigational Site Number :2500009
Investigational Site Number :2030002
Investigational Site Number :7920001
Investigational Site Number :7920006
Investigational Site Number :2030007
Investigational Site Number :2500010
Investigational Site Number :4400002
Investigational Site Number :6160002
Investigational Site Number :7240003
Investigational Site Number :6200002
Investigational Site Number :0360007
Investigational Site Number :6160001
Investigational Site Number :1560014
Investigational Site Number :4400001
Investigational Site Number :7920003
Investigational Site Number :3000002
Investigational Site Number :3920006
Investigational Site Number :6430002
Investigational Site Number :2500006
Investigational Site Number :8400001
Investigational Site Number :7920007
Investigational Site Number :1580003
Investigational Site Number :3800001
Investigational Site Number :0360004
Investigational Site Number :3920002
Investigational Site Number :2080003
Investigational Site Number :1560005
Investigational Site Number :3920009
Investigational Site Number :6200006
Investigational Site Number :3920004
Investigational Site Number :7920002
Investigational Site Number :1560007
Investigational Site Number :1560004
Investigational Site Number :1560012
Investigational Site Number :3920001
Investigational Site Number :1580001
Investigational Site Number :5540002
Investigational Site Number :0360001
Investigational Site Number :2500003
Investigational Site Number :3800004
Investigational Site Number :1560008
Investigational Site Number :2500008
Investigational Site Number :2760003
Investigational Site Number :2500002
Investigational Site Number :1560013
Investigational Site Number :8400006
Investigational Site Number :3800005


location_country:
Finland
Malaysia
Greece
Australia
Belgium
Denmark
India
France
Japan
Poland
Thailand
Norway
Argentina
Canada
Chile
Sweden
Switzerland
Netherlands
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
Spain

acronym: SENSCIS (TM)-ON

location_facility: A.O Universitaria - Università degli Studi della Campania Luigi Vanvitelli

location_facility: Clinical Rheumatology Research Center Sahlgrenska

location_facility: Azienda Universitaria-Universita' La Sapienza

location_facility: The First Hospital of Chinese Medical University

location_facility: University of Florida College of Medicine

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

location_facility: University of Iowa Hospitals and Clinics

location_facility: B.J. Medical College and Sasoon General Hospital

location_facility: Centro Hospitalar Universitário São João,EPE

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: EMED, Center of Medical Services,Private Prac,Rzeszow

location_facility: University of Minnesota Masonic Cancer Center

location_facility: Institute of Rheumatology Tokyo Women's Medical University

location_facility: Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

location_facility: University of Utah Health Sciences Center

location_facility: Vanderbilt University Medical Center - Vanderbilt Lung Institute at 100 Oaks

location_facility: The University of Texas Health Science Center at Houston

location_facility: Oslo Universitetssykehus HF, Rikshospitalet

location_facility: Washington University School of Medicine

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: National Hospital Organization Himeji Medical Center

location_facility: Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente"

location_facility: ULSAM, EPE - Hospital Conde de Bertiandos

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: Froedtert and The Medical College of Wisconsin

location_facility: CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: Postgraduate Institute of Medical Education And Research

location_facility: St. Marianna University School of Medicine Hospital

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Leids Universitair Medisch Centrum (LUMC)

location_facility: CEMER-Centro Medico De Enfermedades Respiratorias

location_facility: Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas

location_facility: Columbia University Medical Center-New York Presbyterian Hospital

location_facility: Specialist Allergy-Internist Center ALL-MED

location_facility: University of Texas Southwestern Medical Center

title: An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With 'Systemic Sclerosis Associated Interstitial Lung Disease' (SSc-ILD)

summary: The main objective is to assess long term safety of treatment with oral nintedanib in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD).


lead_sponsor: Genentech, Inc.

location_country:
Italy
United States
Sweden
Netherlands
Germany
France
Poland
Belgium
Australia
Spain
Denmark
Canada
United Kingdom

location_facility: The Alfred Hospital, Melbourne; Thrombosis and Haemostasis Unit

location_facility: The National Hospital for Neurology & Neurosurgery

location_facility: Sahlgrenska Univ Hospital Mölndal; Department of Nephrology

location_facility: Ospedale San Giovanni Calibita Fatebenefratell;Neurologia

location_facility: Hospital Universitario Reina Sofia; Servicio de Neurologia

location_facility: Neuropsychiatric Research; Center of Southwest Florida

location_facility: Alzheimer's Research and Treatment Center

location_facility: Hospital de Cruces; Servicio de Neurologia

location_facility: Universitätsklinik Tübingen; Psychiatrie und Psychotherapie

location_facility: Klinikum Bayreuth; Krankenhaus Hohe Warte

location_facility: CHU Hautepierre; ACTR Association Recherche Clinique Rhumatologie

location_facility: Hospital de Cantoblanco; Servicio de Geriatria

location_facility: Studienambulanz emovis GmbH; St. Joseph Krankenhaus

location_facility: Umberto I Policlinico di Roma-Università di Roma La Sapienza

location_facility: Clinical Neuroscience Research Associates, Inc.

location_facility: KI Health Partners, LLC; New England Institute for Clinical Research

location_facility: Neurologisch-psychiatrische Praxis am Brosepark

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Skane University Hospital Malmo/Lund, Dept.of Hematology and Coagulation Disorders

location_facility: JBN Medical Diagnostic Services; Clinical Trials Division

location_facility: Klinikum rechts der Isar der TU München; Klinik & Poliklinik für Neurologie

location_facility: Parkwood Institute, Mental Health Care Building

location_facility: Senior Sp. Z O.O. Poradnia Psychogeriatryczna

location_facility: Advanced Memory Research Institute of NJ

location_facility: Hospital Perpetuo Socorro, Servicio de Geriatria

location_facility: IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA

location_facility: Groupe Hospitalier Pellegrin; Service de Neurologie - 3ème étage

location_facility: Empire Neurology PC; MS Center of Northeastern NY

location_facility: Eastern Clinical Research Unit; Pharmacy

location_facility: Universitätsklinikum Ulm; Klinik für Neurologie

location_facility: Az. Osp. C. Panico; Rep. Ematologia E Trapianto

location_facility: Stanford Neuroscience Health Center (SNHC)

location_facility: Health Partners Institute for Education and Research

location_facility: HammondCare Aged Psychiatry Clinical Trials

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta

location_facility: Center For Clinical and Basic Research (Ccbr); Site Management Organisation

location_facility: Clinica Universitaria de Navarra; Servicio de Neurología

location_facility: Azienda Ospedaliero Universitaria San Martino; Dip. di Neuroscienze Oftalmologia e Genetica

location_facility: CHU de la Timone - Hopital d Adultes; Service de Neurologie

location_facility: Hospital Universitario Dr. Peset; Servicio de Neurologia

location_facility: New Orleans Center For Clinical Research

location_facility: Southern Illinois University, School of Medicine

location_facility: PALLMED Sp. z o.o. prowadząca NZOZ DOM SUE RYDER

title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of MTAU9937A in Patients With Prodromal to Mild Alzheimer's Disease

summary: This is a phase II, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of Semorinemab in participants with prodromal to mild Alzheimer's disease. An optional 96-week open-label extension period will be available to participants who complete the double-blind treatment period and who, in the judgment of the investigator, would potentially benefit from open-label Semorinemab treatment.


title: Prospective, Randomized, Controlled, Double-blind, Multi-centre, Multinational Study on the Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery

acronym: PHOENICS

summary: The aim of the study is to investigate the safety of a 6% HES (Hydroxyethyl Starch) solution (Volulyte 6%) versus an electrolyte solution (Ionolyte) in patients undergoing elective abdominal surgery.

ReferenceType: derived

ReferenceCitation: Chappell D, Jacob M. Should hydroxyethyl starch be banned? Lancet. 2018 Jul 14;392(10142):118. doi: 10.1016/S0140-6736(18)31174-7.

family: Chappell

full_name: Daniel Chappell

given: Daniel

sequence: first

family: Jacob

full_name: Matthias Jacob

given: Matthias

sequence: additional

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The Lancet

evidence: open (via free pdf)

license_normalized: no license

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Should hydroxyethyl starch be banned?

lead_sponsor: Fresenius Kabi

location_country: Austria Netherlands Croatia Czechia France Poland Romania Belgium Spain Germany

location_facility: Karol Marcinkowski Medical University in Poznań

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: Jagiollonian University Hospital Medical College

location_facility: Hospital Universitario de Gran Canaria Dr. Negrín

location_facility: Social Medical Center East - Donauspital

location_facility: Hospital Universitari i Politecnic la Fe

location_facility: University Hospital Schleswig-Holstein Campus Kiel

location_facility: University Medical Center (UMC) Maastricht


title: A Multi-centre, Open-label, Randomized Clinical Trial Comparing the Efficacy and Safety of the Antibody-drug Conjugate SYD985 to Physician's Choice in Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer

acronym: TULIP

summary: The purpose of this study is to demonstrate that SYD985 [(vic-)trastuzumab duocarmazine] is superior to physician's choice in prolonging progression free survival.

lead_sponsor: Byondis B.V.

location_country:
Italy
United States
Sweden
Netherlands
France
Singapore
Belgium
Spain
Denmark
Canada
United Kingdom

location_facility: BC Cancer Agency Centre for the Southern Interior

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Hospital Clinico Universitario de Valencia

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Texas Oncology- Baylor Charles A. Sammor

location_facility: Texas Oncology PA (Texas Oncology-Dallas Presbyterian Hospital)

location_facility: Hospital General Universitario de Alicante

location_facility: Hospital Universitari Vall d'Hebron Vall d' Hebron Institute of Oncology (VHIO)

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: Istituto Nazionale dei Tumori Regina Elena


title: Phase III Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of the Addition of Crenolanib to Salvage Chemotherapy Versus Salvage Chemotherapy Alone in Subjects ≤ 75 Years of Age With Relapsed/Refractory FLT3 Mutated Acute Myeloid Leukemia

summary: This is a randomized, multi-center, double-blind, placebo-controlled study designed to evaluate the efficacy of crenolanib administered following salvage chemotherapy, consolidation chemotherapy, post bone marrow transplantation and as maintenance in relapsed/refractory AML subjects with FLT3 activating mutation.

lead_sponsor: Arog Pharmaceuticals, Inc.

location_country:
Italy
United States
France
Spain
Germany
Canada

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Ospedale Santa Maria delle Croci di Ravenna

location_facility: Hospital Center of Versailles (Le Chesnay)

location_facility: Institut Universitaire du Cancer Toulouse

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: IRCCS Foundation Ca 'Granda Ospedale Maggiore Policlinico

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

location_facility: Hospital Universitario Central de Asturias (HUCA)

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Hospital Gregorio Maranon Servicio de Hematologia y Hemoterapia

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: A.O.U. Città della Salute e della Scienza di Torino

location_facility: Policlinico GB Rossi, University Hospital Verona

location_facility: AO Ospedali Riuniti Villa Sofia-Cervello


ReferenceCitation: Bang YJ, Van Cutsem E, Fuchs CS, Ohtsu A, Tabernero J, Ilson DH, Hyung WJ, Strong VE, Goetze TO, Yoshikawa T, Tang LH, Hwang PMT, Webb N, Adelberg D, Shitara K. KEYNOTE-585: Phase III study of perioperative chemotherapy with or without pembrolizumab for gastric cancer. Future Oncol. 2019 Mar;15(9):943-952. doi: 10.2217/fon-2018-0581. Epub 2019 Feb 19.

name: Seoul National University College of Medicine, 101 Daehak-ro, Ihwa-Dong, Seoul, Republic of Korea

family: Bang

full_name: Yung-Jue Bang

given: Yung-Jue

name: University Hospitals Gasthuisberg Leuven & KU Leuven, 49 Herestraat, Leuven 3001, Belgium

family: Van Cutsem

full_name: Eric Van Cutsem

name: Yale Cancer Center and Smilow Cancer Hospital, 333 Cedar Street, New Haven, CT 06510, USA

family: Fuchs

full_name: Charles S Fuchs

given: Charles S

name: National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba 277-8577, Japan

family: Ohtsu

full_name: Atsushi Ohtsu

given: Atsushi

name: Vall d'Hebron University Hospital & Institute of Oncology (VHIO), Vall d'Hebron 119–129, 08035 Universitat Autònoma de Barcelona, Barcelona, Spain

family: Tabernero

full_name: Josep Tabernero

given: Josep

name: Memorial Sloan Kettering Cancer Center, 300 East 66th Street, BAIC 1031, New York, NY 10065, USA

family: Ilson

full_name: David H Ilson

given: David H

name: Yonsei Cancer Hospital, Yonsei University Health System, 50-1 Yonsei-Ro Seodaemun-gu, Seoul 03722, Republic of Korea

family: Hyung

full_name: Woo Jin Hyung

given: Woo Jin

name: Memorial Sloan Kettering Cancer Center, 1275 York Ave, New York, NY 10065, USA

family: Strong

full_name: Vivian E Strong

given: Vivian E

name: Institute of Clinical Cancer Research, UCT University Cancer Center Frankfurt, Steinbacher Hohl 2-26, Frankfurt 60488, Germany

family: Goetze

full_name: Thorsten Oliver Goetze

given: Thorsten Oliver

name: National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan

family: Yoshikawa

full_name: Takaki Yoshikawa

given: Takaki

family: Tang

full_name: Laura H Tang

given: Laura H

name: Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA

family: Hwang

full_name: Peggy May Tan Hwang

given: Peggy May Tan

family: Webb

full_name: Nancy Webb

given: Nancy

family: Adelberg

full_name: David Adelberg

given: David

family: Shitara

full_name: Kohei Shitara

given: Kohei

oa_colors: green other

oa_host_type: publisher;repository

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

host_type: repository

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

version: submittedVersion

lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Guatemala
Malaysia
Belgium
Russian Federation
Taiwan
Ukraine
France
Japan
Lithuania
Poland
Canada
Korea, Republic of
Chile
Philippines
Singapore
China
United States
Germany
United Kingdom
Italy
Brazil
Israel
Estonia
Latvia

acronym: NAC/Adj GEJ Adenocarcinoma with Chemo (XP/FP) vs Chemo + Pembro Study

location_facility: Osaka Medical College Hospital ( Site 0168)

location_facility: Kliniken Essen Mitte Gmbh Evang. Huyssens Stiftung ( Site 0445)

location_facility: Chonnam National University Hwasun Hospital ( Site 0083)

location_facility: Ninewells Hospital and Medical School ( Site 0406)

location_facility: Virginia Cancer Specialists, PC ( Site 0010)

location_facility: Osaka General Medical Center ( Site 0159)

location_facility: Hokkaido University Hospital ( Site 0160)

location_facility: Toyama Prefectural Central Hospital ( Site 0163)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 0186)

location_facility: Ibaraki Prefectural Central Hospital ( Site 0177)

location_facility: Seoul National University Hospital -SNUH- ( Site 0080)

location_facility: Roswell Park Cancer Institute ( Site 0001)

location_facility: Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0018)

location_facility: The Royal Marsden Foundation Trust ( Site 0405)

location_facility: A.O.U. Santa Maria della Misericordia di Udine ( Site 0434)

location_facility: Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0469)

location_facility: Kumamoto University Hospital ( Site 0164)

location_facility: Hospital Clinico Universidad de Chile ( Site 0287)

location_facility: Riga East Clinical University Hospital ( Site 0550)

location_facility: Wojewodzki Szpital Specjalistyczny we Wroclawiu ( Site 0358)

location_facility: Tomsk Scientific Research Institute of Oncology ( Site 0337)

location_facility: Kochi Health Sciences Center ( Site 0189)

location_facility: Vilniaus Universiteto Ligonine Santaros Klinikos ( Site 0568)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0305)

location_facility: Tokyo Metropolitan Komagome Hospital ( Site 0183)

location_facility: Blokhin National Medical Oncology ( Site 0494)

location_facility: Korea University Anam Hospital ( Site 0084)

location_facility: Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 0354)

location_facility: CHU Poitiers - Pole Regional de Cancerologie ( Site 0467)

location_facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 0591)

location_facility: Haematologisch-Onkologische Praxis Eppendorf Facharztzentrum Eppendorf - Hope ( Site 0454)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 0172)

location_facility: University Hospitals Bristol NHS Foundation Trust ( Site 0407)

location_facility: Kyiv City Clinical Oncology Center ( Site 0590)

location_facility: Szpital Uniwersytecki w Krakowie ( Site 0352)

location_facility: IRCCS Istituto Oncologico Veneto ( Site 0431)

location_facility: Kyungpook National University Chilgok Hospital ( Site 0089)

location_facility: Medizinische klinilk und Poliklinik Johannes Gutenberg Univ ( Site 0455)

location_facility: CHU Reims - Hopital Robert Debre ( Site 0465)

location_facility: Universitaetsklinikum Freiburg ( Site 0450)

location_facility: Klinikum der Universitaet in Muenchen ( Site 0446)

location_facility: CISSS de la Monteregie-Centre ( Site 0039)

location_facility: National University Hospital ( Site 0095)

location_facility: MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council ( Site 0589)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0286)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0344)

location_facility: National Cancer Institute of the MoH of Ukraine ( Site 0319)

location_facility: Royal Marsden NHS Foundation Trust ( Site 0400)

location_facility: St. Marianna University School of Medicine Hospital ( Site 0187)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 0176)

location_facility: University of Utah, Huntsman Cancer Institute ( Site 0012)

location_facility: Chang Gung Medical Foundation. Linkou ( Site 0064)

location_facility: National Cancer Centre Singapore ( Site 0097)

location_facility: Hiroshima City Hiroshima Citizens Hospital ( Site 0171)

location_facility: Institut Mutualiste Montsouris ( Site 0463)

location_facility: Instituto do Cancer do Ceara ( Site 0311)

location_facility: The Cancer Institute Hospital of JFCR ( Site 0185)

location_facility: Taipei Medical University Shuang Ho Hospital ( Site 0068)

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0301)

location_facility: Instituto Nacional Do Cancer Jose Alencar Gomes Da Silva ( Site 0307)

location_facility: The University of Chicago Medical Center ( Site 0004)

location_facility: The Christie NHS Foundation Trust ( Site 0397)

location_facility: Koo Foundation Sun Yat-Sen Cancer Center ( Site 0066)

location_facility: Centro Medico Integral De Cancerología (CEMIC) ( Site 0260)

location_facility: CHRU Lille - Hopital Claude Huriez ( Site 0461)

location_facility: City clinical oncological dispensary ( Site 0336)

location_facility: National Cheng Kung University Hospital ( Site 0067)

location_facility: CHU UCL Namur Site de Godinne ( Site 0485)

location_facility: Leningrad Regional Oncology Center ( Site 0335)

location_facility: CHU Brest - Institut de Cancerologie et d Hematologie ( Site 0474)

location_facility: Medizinische Hochschule Hannover ( Site 0449)

location_facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0040)

location_facility: SBHI Leningrad Regional Clinical Hospital ( Site 0496)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0430)

location_facility: CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0035)

location_facility: Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 0448)

location_facility: Kobe City Medical Center General Hospital ( Site 0181)

location_facility: Institut du Cancer de Montpellier ( Site 0473)

location_facility: Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 0353)

location_facility: Seoul National University Bundang Hospital ( Site 0085)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0285)

location_facility: National Taiwan University Hospital ( Site 0063)

location_facility: IRCCS Policlinico San Donato ( Site 0433)

location_facility: Kaluga Regional Clinical Oncology Center ( Site 0345)

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0308)

location_facility: National Medical and Surgical Center n.a. N.I.Pirogov ( Site 0338)

location_facility: Ivano-Frankivsk Regional Oncology Clinical Dispensary ( Site 0321)

location_facility: SA Pohja-Eesti Regionaalhaigla ( Site 0526)

location_facility: National Cancer Center Hospital East ( Site 0178)

location_facility: Aichi Cancer Center Hospital ( Site 0165)

location_facility: CEPON - Centro de Pesquisas Oncologicas ( Site 0302)

location_facility: Imperial College Healthcare NHS Trust ( Site 0402)

location_facility: Moncton Hospital - Horizon Health Network ( Site 0038)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0361)

location_facility: Gachon University Gil Medical Center ( Site 0087)

location_facility: National Cancer Center Hospital ( Site 0179)

location_facility: Severance Hospital Yonsei University Health System ( Site 0081)

location_facility: Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0429)

location_facility: Royal Free London NHS Foundation Trust ( Site 0403)

location_facility: Nacionalinis Vezio Institutas ( Site 0569)

location_facility: City Clinical Hosp.4 of DCC ( Site 0325)

location_facility: Mazowiecki Szpital Onkologiczny ( Site 0363)

location_facility: Sunnybrook Research Institute ( Site 0032)

location_facility: CHU de Quebec - Hotel-Dieu de Quebec ( Site 0042)

location_facility: Hadassah Medical Center. Ein Kerem ( Site 0383)

location_facility: Instituto Clinico del Sur. ICOS ( Site 0290)

location_facility: SMG-SNU BORAMAE Medical Center ( Site 0086)

location_facility: Osaka International Cancer Institute ( Site 0161)

location_facility: University Malaya Medical Centre ( Site 0143)

location_facility: Hospital de Base de Sao Jose de Rio Preto ( Site 0304)

location_facility: Istituto Clinico Humanitas Research Hospital ( Site 0432)

location_facility: Hospital Israelita Albert Einstein ( Site 0309)

location_facility: CHU Toulouse - Hopital Rangueil ( Site 0470)

location_facility: Weill Cornell Medical Center ( Site 0023)

location_facility: Iwate Medical University Hospital ( Site 0184)

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 0351)

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0019)

location_facility: Hospital Regional Rancagua Libertador Bernardo O Higgins ( Site 0299)

location_facility: Kansai Medical University Hospital ( Site 0190)

location_facility: Niigata Cancer Center Hospital ( Site 0169)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0349)

title: A Phase III, Randomized, Double-Blind, Clinical Trial of Pembrolizumab (MK-3475) Plus Chemotherapy (XP or FP) Versus Placebo Plus Chemotherapy (XP or FP) as Neoadjuvant/Adjuvant Treatment for Subjects With Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma (KEYNOTE-585)

summary:
The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.

The primary study hypotheses are that:

Neoadjuvant and adjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab is superior to neoadjuvant and adjuvant placebo plus chemotherapy, followed by adjuvant placebo in terms of Event-free Survival (EFS) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), and
Neoadjuvant pembrolizumab plus chemotherapy is superior to neoadjuvant placebo plus chemotherapy in terms of rate of Pathological Complete Response (pathCR) at the time of surgery.


ReferenceCitation: Marconi L, Sun M, Beisland C, Klatte T, Ljungberg B, Stewart GD, Dabestani S, Choueiri TK, Bex A. Prevalence, Disease-free, and Overall Survival of Contemporary Patients With Renal Cell Carcinoma Eligible for Adjuvant Checkpoint Inhibitor Trials. Clin Genitourin Cancer. 2021 Apr;19(2):e92-e99. doi: 10.1016/j.clgc.2020.12.005. Epub 2021 Jan 7.

family: Marconi

full_name: Lorenzo Marconi

given: Lorenzo

family: Sun

full_name: Maxine Sun

given: Maxine

family: Beisland

full_name: Christian Beisland

given: Christian

family: Klatte

full_name: Tobias Klatte

given: Tobias

family: Ljungberg

full_name: Boerje Ljungberg

given: Boerje

family: Stewart

full_name: Grant D. Stewart

given: Grant D.

family: Dabestani

full_name: Saeed Dabestani

given: Saeed

family: Choueiri

full_name: Toni K. Choueiri

given: Toni K.

family: Bex

full_name: Axel Bex

given: Axel

journal_name: Clinical Genitourinary Cancer

location_country:
Romania
Australia
Belgium
Russian Federation
France
Japan
Poland
Argentina
Canada
Colombia
Chile
Switzerland
Netherlands
Singapore
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Spain
Turkey

acronym: CheckMate 914

location_facility: Integrated Clinical Oncology Network Pty Ltd (ICON)

location_facility: Instituto do Cancer do Estado de Sao Paulo ICESP

location_facility: Klinikum Nuernberg Nord, Urologische Klinik

location_facility: Instituto Nacional de Cancerología-Clinical Oncology

location_facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia

location_facility: PERSONAL Oncologia de Precisao e Personalizada

location_facility: Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli

location_facility: Meridan Health System-Jersey Shore Medical Center

location_facility: Centro Polivalente de Asistencia e Investigacion Clinica CER San Juan

location_facility: Fundacao Pio Xii Hosp Cancer De Barretos

location_facility: Erlanger Oncology & Hematology - Univ. of TN

location_facility: California Pacific Medical Center Research Institute

location_facility: Fondazione Policlinico Universitario A. Gemelli

title: A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab vs Placebo in Participants With Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse

summary: The purpose of this study is to determine whether nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in participants who have experienced partial or entire removal of a kidney.


ReferenceCitation: Stratigos AJ, Sekulic A, Peris K, Bechter O, Prey S, Kaatz M, Lewis KD, Basset-Seguin N, Chang ALS, Dalle S, Orland AF, Licitra L, Robert C, Ulrich C, Hauschild A, Migden MR, Dummer R, Li S, Yoo SY, Mohan K, Coates E, Jankovic V, Fiaschi N, Okoye E, Bassukas ID, Loquai C, De Giorgi V, Eroglu Z, Gutzmer R, Ulrich J, Puig S, Seebach F, Thurston G, Weinreich DM, Yancopoulos GD, Lowy I, Bowler T, Fury MG. Cemiplimab in locally advanced basal cell carcinoma after hedgehog inhibitor therapy: an open-label, multi-centre, single-arm, phase 2 trial. Lancet Oncol. 2021 Jun;22(6):848-857. doi: 10.1016/S1470-2045(21)00126-1. Epub 2021 May 14.

family: Stratigos

full_name: Alexander J Stratigos

given: Alexander J

family: Sekulic

full_name: Aleksandar Sekulic

given: Aleksandar

family: Peris

full_name: Ketty Peris

given: Ketty

family: Bechter

full_name: Oliver Bechter

given: Oliver

family: Prey

full_name: Sorilla Prey

given: Sorilla

family: Kaatz

full_name: Martin Kaatz

given: Martin

family: Lewis

full_name: Karl D Lewis

given: Karl D

family: Basset-Seguin

full_name: Nicole Basset-Seguin

given: Nicole

family: Chang

full_name: Anne Lynn S Chang

given: Anne Lynn S

family: Dalle

full_name: Stèphane Dalle

given: Stèphane

family: Orland

full_name: Almudena Fernandez Orland

given: Almudena Fernandez

family: Licitra

full_name: Lisa Licitra

given: Lisa

family: Robert

full_name: Caroline Robert

given: Caroline

family: Ulrich

full_name: Claas Ulrich

given: Claas

family: Hauschild

full_name: Axel Hauschild

family: Migden

full_name: Michael R Migden

given: Michael R

family: Dummer

full_name: Reinhard Dummer

given: Reinhard

family: Li

full_name: Siyu Li

given: Siyu

family: Yoo

full_name: Suk-Young Yoo

given: Suk-Young

family: Mohan

full_name: Kosalai Mohan

given: Kosalai

family: Coates

full_name: Ebony Coates

given: Ebony

family: Jankovic

full_name: Vladimir Jankovic

given: Vladimir

family: Fiaschi

full_name: Nathalie Fiaschi

given: Nathalie

family: Okoye

full_name: Emmanuel Okoye

given: Emmanuel

family: Bassukas

full_name: Ioannis D Bassukas

given: Ioannis D

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

ReferenceCitation: Li R, Lee G, Huang M, El-Sherief A. Rare basal cell metastasis of a basal-squamous skin collision tumour to the lung and axillary lymph node. BMJ Case Rep. 2019 Oct 3;12(10). pii: e231487. doi: 10.1136/bcr-2019-231487.

location_country:
Italy
Austria
United States
Switzerland
Germany
France
Greece
Belgium
Spain
Canada

location_facility: James Cancer Hospital and Solove Research Institute

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: UCSF Helen Dillion Family Cancer Care Center

location_facility: University General Hospital of Ioannina - Dermatology and Venereology Department

location_facility: Centre Hospitalier Lyon-Sud -Hospices Civils de Lyon Groupement Hospitalier Sud

location_facility: U.O.S.C Di Oncologia Medica E Terapie Innovative

location_facility: H Lee Moffitt Cancer Center and Research Institute

location_facility: Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Saint-André - Hôpital Saint-André

location_facility: The University of Arizona Cancer Centre at Dignity Health

location_facility: University of Colorado Hospital, Anschutz Outpatient Pavilion

location_facility: Hauttumorcentrum der Charite (HTCC)-Charite Universitatsmedizin Berlin

location_facility: Washington University School of Medicine

location_facility: Mayo Clinic Arizona - Mayo Clinic Hospital

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Odette Cancer Center-Sunnybrook Health Sciences Centre

location_facility: National and Kapodistrian University of Athens - School of Health Sciences - Faculty of Medicine

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Hospital Clinic I Provincialde Barcelona

location_facility: U.O.Dermatologia Azienda Sanitaria Firenze Universita' Firenze

location_facility: Clinical Research Center of the Carolinas

location_facility: Medizinische Universitaet Innsbruck, Universitaetsklinik fuer Dermatologie, Venerologie und Allergologie

location_facility: London Regional Cancer Program, London Hsc

location_facility: Policlinico S.Orsola-Malpighi U.O. Dermatologia - University of Bologna

location_facility: Andreas Sygros Hosptial-University of Athen

location_facility: Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Stanford Medicine Outpatient Center - Stanford Dermatology Clinic-Stanford University School of Medicine

location_facility: Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: New York University School Of Medicine, Kaplan Comprehensive Cancer Center

location_facility: Atlantic Health System / Morristown Medical Center

location_facility: Klinik Fur Dermatologie Und Allergollogie

title: A Phase 2 Study of REGN2810, a Fully Human Monoclonal Antibody to Programmed Death-1, in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy

summary: The primary objective is to estimate the objective response rate (ORR) for metastatic Basal Cell Carcinoma (BCC) (group 1) and for unresectable locally advanced BCC (group 2) when treated with cemiplimab as a monotherapy


lead_sponsor: Janssen-Cilag Ltd.

location_country:
Italy
Sweden
Netherlands
Spain
France
Czechia
Slovakia
Belgium
Portugal
Denmark
Germany
United Kingdom

acronym: STARDUST

location_facility: Gastroenterology and Hepatology Center Nitra, KM Management spol. s r.o.

location_facility: Azienda Sanitaria Universitaria Integrata di Udine

location_facility: County Durham and Darlington NHS Foundation Trust

location_facility: St George's University Hosptial NHS Foundation Trust

location_facility: Centro Hospitalar e Universitário do Algarve

location_facility: Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum

location_facility: Azienda Ospedaliera G.Salvini Ospedale di Rho

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Centro Hospitalar Lisboa Central, EPE - Hospital Santo Antonio dos Capuchos

location_facility: Gastroenterology Department GASTROMART s.r.o.

location_facility: Centro Hospitalar Lisboa Norte, EPE/Hosp. Santa Maria

location_facility: Gastroenterology Department ENDOMED, s.r.o.

location_facility: Policlinico di Bari Ospedale Giovanni XXIII

location_facility: Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar

location_facility: University Hospital in Bratislava, St. Cyril and Method Hospital

location_facility: Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus

location_facility: Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: Fondazione Policlinico Gemelli Università Cattolica

title: Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With Ustekinumab

summary: The purpose of this study is to evaluate the efficacy of a treat to target strategy coupled with early endoscopic assessment versus a clinically driven (routine care) approach in achieving endoscopic response.