title: A Phase 2b, Multicenter, Double-blind, Active-controlled, Randomized Study to Investigate the Efficacy and Safety of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection

lead_sponsor: Janssen Sciences Ireland UC

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

location_country:
Poland
Brazil
Hong Kong
Spain
Italy
Russian Federation
United Kingdom
Canada
Thailand
Korea, Republic of
United States
France
China
Malaysia
Belgium
Japan
Germany
Turkey
Czechia

location_facility: Washington University School of Medicine

location_facility: Fundação De Medicina Tropical Doutor Heitor Vieira Dourado

location_facility: Azienda Ospedaliero-Universitaria di Modena, Ospedale di Baggiovara

location_facility: Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza w Bydgoszczy

location_facility: Universita degli Studi di Roma 'La Sapienza' - Umberto I Policlinico di Roma

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: Hospital das Clinicas da Universidade Federal da Bahia

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Karadeniz Teknik University Medical Faculty

location_facility: The Hospital of Hyogo College of Medicine

location_facility: Sverdlovsk Regional Clinical Hospital #1

location_facility: St. Petersburg City Center for AIDS and Infectious Diseases Treatment and Prophylaxis

location_facility: Vancouver ID Research and Care Centre Society

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Krasnoyarsk Regional Center For AIDS And Infectious Diseases Treatment And Prophylaxis

location_facility: Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Tokyo Medical and Dental University Hospital

location_facility: NHS Greater Glasgow and Clyde - Gartnavel General Hospital

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1

location_facility: St George's, University of London and St George's University Hospitals NHS Foundation Trust

location_facility: University of Alberta - Faculty of Medicine & Dentistry

location_facility: Ege University Medical of Faculty, Department of Gastroenterology

location_facility: Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: Neutrum Lekarze M.Hlebowicz i Partnerzy spolka partnerska

location_facility: Clinical Infectious Diseases Hospital n. a. S.P. Botkin

summary: The purpose of this study is to establish the dose-response relationship for antiviral activity of 3 dose levels of JNJ-73763989+nucleos(t)ide analog (NA) and to evaluate the efficacy of combination regimens of JNJ-73763989+NA (with and without JNJ-56136379) and of JNJ-56136379+NA.


title: An Open-label, Phase 2 Study of ACP-196 in Subjects With Mantle Cell Lymphoma

summary: The purpose of this study is to characterize the safety and efficacy profile of ACP-196 (acalabrutinib) in subjects with relapsed or refractory Mantle Cell Lymphoma (MCL).

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Wang M, Rule S, Zinzani PL, Goy A, Casasnovas O, Smith SD, Damaj G, Doorduijn J, Lamy T, Morschhauser F, Panizo C, Shah B, Davies A, Eek R, Dupuis J, Jacobsen E, Kater AP, Le Gouill S, Oberic L, Robak T, Covey T, Dua R, Hamdy A, Huang X, Izumi R, Patel P, Rothbaum W, Slatter JG, Jurczak W. Acalabrutinib in relapsed or refractory mantle cell lymphoma (ACE-LY-004): a single-arm, multicentre, phase 2 trial. Lancet. 2018 Feb 17;391(10121):659-667. doi: 10.1016/S0140-6736(17)33108-2. Epub 2017 Dec 11.

ipd_sharing: Yes

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. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: Acerta Pharma BV

location_country:
Poland
Spain
Italy
United Kingdom
Australia
United States
France
Belgium
Netherlands
Czechia

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase II, Multi-Center, Single-Arm, Global Study of MEDI4736 Monotherapy in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

summary: Primary Objective: To assess the efficacy of MEDI4736 monotherapy in terms of ORR

status: Completed

study_completion_date_type: Actual

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

location_country:
Taiwan
Spain
United Kingdom
Georgia
Canada
Hungary
Korea, Republic of
France
United States
Israel
Malaysia
Belgium
Germany
Czechia

status_simplified: Completed


title: AdaptResponse Clinical Trial

summary: The purpose of this clinical study is to test the hypothesis that market released Cardiac Resynchronization Therapy (CRT) devices which contain the AdaptivCRT® (aCRT) algorithm have a superior outcome compared to standard CRT devices in CRT indicated patients with normal atrio-ventricular (AV) conduction and left bundle branch block (LBBB).

design_allocation: Randomized

enrollment_type: Anticipated

ReferenceCitation: Wilkoff BL, Birnie D, Gold MR, Hersi AS, Jacobs S, Gerritse B, Kusano K, Leclercq C, Mullens W, Filippatos G. Differences in clinical characteristics and reported quality of life of men and women undergoing cardiac resynchronization therapy. ESC Heart Fail. 2020 Oct;7(5):2972-2982. doi: 10.1002/ehf2.12914. Epub 2020 Aug 13.

ReferenceCitation: Filippatos G, Birnie D, Gold MR, Gerritse B, Hersi A, Jacobs S, Kusano K, Leclercq C, Mullens W, Wilkoff BL; AdaptResponse Investigators. Rationale and design of the AdaptResponse trial: a prospective randomized study of cardiac resynchronization therapy with preferential adaptive left ventricular-only pacing. Eur J Heart Fail. 2017 Jul;19(7):950-957. doi: 10.1002/ejhf.895. Review.

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Saudi Arabia
Italy
Spain
United Kingdom
United States
Belgium
Japan
Poland
Portugal
Austria
Australia
Russian Federation
Puerto Rico
India
Mexico
Norway
Sweden
Slovakia
Canada
Switzerland
Hungary
Germany
Denmark
Taiwan
Finland
Korea, Republic of
France
Netherlands

location_facility: Washington University School of Medicine

location_facility: University of South Florida Health (USF)

location_facility: Almazov National Medical Research Centre

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Scripps Green Hospital Scripps Clinic Torrey Pines

location_facility: Amphia Ziekenhuis - Locatie Molengracht Breda

location_facility: Prairie Education and Research Cooperative

location_facility: Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach

location_facility: Weill Medical College of Cornell University

location_facility: Centennial Heart Cardiovascular Consultants LLC

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Märkische Gesundheitsholding GmbH & Co. KG - Klinikum Lüdenscheid

location_facility: Centre Hospitalier Universitaire de Grenoble-Hopital Albert Michallon

location_facility: CHI St. Luke's Heath Baylor College of Medicine Medical Center

location_facility: Helse Bergen HF - Haukeland Universitetssjukehus

location_facility: University Hospitals Case Medical Center

location_facility: CHRU de Montpellier - Hôpital Arnaud de Villeneuve

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied

location_facility: National Taiwan University Hospital Hsin Chu Branch

location_facility: Hôpital de la Timone - Centre Hospitalier Universitaire de Marseille

location_facility: Immanuel Diakonie Group - Evangelisch-Freikirchlichen Krankenhaus und Herzzentrum Brandenburg

location_facility: University of Minnesota Medical Center Fairview

location_facility: Medical University of South Carolina (MUSC)

location_facility: Saitama Medical Center Jichi Medical University

location_facility: Wojewódzki Szpital Zespolony im. Ludwika Perzyny w Kaliszu

location_facility: Cardiovascular Research Center of South Florida

location_facility: Centre Hospitalier Universitaire de Amiens - Hôpital SU

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

location_facility: groupe Hospitalier de L'Institut Catholique de Lille - Hôpital Saint-Philibert

location_facility: Manchester University NHS Foundation Trust - Wythenshawe Hospital

location_facility: Klinikum der Universität München - Campus Großhadern

location_facility: Glacier View Research Institute Cardiology

location_facility: Ziekenhuis Oost Limburg - Campus St.-Jan

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

location_facility: The University of Texas (UT) Southwestern Medical Center

location_facility: Kliniken Maria Hilf GmbH Mönchengladbach - Krankenhaus St. Franziskus

location_facility: Stredoslovensky ustav srdcovych a cievnych chorob a.s

location_facility: London Health Sciences Centre - University Campus

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: Unidade Local de Saude do Baixo Alentejo, EPE - Hospital José Joaquim Fernandes

location_facility: Wake Forest Baptist Health High Point Medical Center

location_facility: Azienda Ospedaliero-Universitaria di Parma

location_facility: Universitätsklinikum Schleswig-Holstein - Campus Lübeck

location_facility: Massachusetts General Hospital (Boston MA)

location_facility: MVZ am Küchwald GmbH ambulantes Herz Zentrum Chemnitz

location_facility: National Cerebral and Cardiovascular Center

location_facility: Royal Brompton & Harefield NHS Foundation Trust - Royal Brompton Hospital

location_facility: University of Pittsburgh Medical Center UPMC Presbyterian

location_facility: Berufsgenossenschaftliche Universitätsklinik Bergmannsheil GmbH

location_facility: Golden Jubilee National Hospital - NHS Trust

location_facility: Saint Francis Medical Group Indiana Heart Physician

location_facility: Seoul National University Bundang Hospital

location_facility: Otto von Guericke Universität - Universitätsklinikum Magdeburg A.ö.R.

location_facility: Universitätsklinikum Jena - Friedrich Schiller Universität

location_facility: Keimyung University Dongsan Medical Center

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Virginia Commonwealth University Health System

location_facility: EN Meshalkin National medical research center of the Ministry of Health of the Russian Federation

location_facility: Liverpool Heart and Chest Hospital NHS Foundation Trust

location_facility: Complexo Hospitalario Universitario de Vigo - Hospital Xeral Cíes

location_facility: CAMC Health Education & Research Institute Inc

location_facility: Praxisklinik Herz und Gefässe - Akademische Lehrpraxisklinik der TU Dresden

location_facility: AV Vishnevsky Institute of Surgery of the Ministry of Health of the Russian Federation

location_facility: The College of Medicine & King Khalid University Hospital, King Saud University

location_facility: Hospital Universitario Nuestra Señora de Candelaria

location_facility: Oklahoma Heart Hospital Research Foundation

location_facility: Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum

location_facility: University Hospitals of North Midlands NHS Trust - Royal Stoke University Hospital

location_facility: The University of Vermont Medical Center Inc

location_facility: Cardiology Institute of Northwest Florida

location_facility: AdventHealth Cardiovascular Research Institute

location_facility: Landeskrankenhaus Innsbruck - Universitätskliniken

location_facility: Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego

location_facility: Phoenix Cardiovascular Research Group, LLC

location_facility: North Memorial Heart and Vascular Institute

intervention_type: Device


acronym: ARAMIS

title: A Multinational, Randomised, Double-blind, Placebo-controlled, Phase III Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer

lead_sponsor: Bayer

type: EudraCT Number

source: euctr

ReferenceCitation: Chowdhury S, Oudard S, Uemura H, Joniau S, Dearden L, Capone C, Van Sanden S, Diels J, Hadaschik BA. Apalutamide Compared with Darolutamide for the Treatment of Non-metastatic Castration-Resistant Prostate Cancer: Efficacy and Tolerability in a Matching-Adjusted Indirect Comparison. Adv Ther. 2022 Jan;39(1):518-531. doi: 10.1007/s12325-021-01885-6. Epub 2021 Nov 19.

ReferenceCitation: Fizazi K, Blue I, Nowak JT. Darolutamide and survival in nonmetastatic, castration-resistant prostate cancer: a patient perspective of the ARAMIS trial. Future Oncol. 2021 May;17(14):1699-1707. doi: 10.2217/fon-2020-1291. Epub 2021 Feb 8. Erratum in: Future Oncol. 2022 Jan;18(2):275.

ReferenceCitation: Fizazi K, Shore N, Tammela TL, Ulys A, Vjaters E, Polyakov S, Jievaltas M, Luz M, Alekseev B, Kuss I, Le Berre MA, Petrenciuc O, Snapir A, Sarapohja T, Smith MR; ARAMIS Investigators. Nonmetastatic, Castration-Resistant Prostate Cancer and Survival with Darolutamide. N Engl J Med. 2020 Sep 10;383(11):1040-1049. doi: 10.1056/NEJMoa2001342.

ReferenceCitation: Shore N, Zurth C, Fricke R, Gieschen H, Graudenz K, Koskinen M, Ploeger B, Moss J, Prien O, Borghesi G, Petrenciuc O, Tammela TL, Kuss I, Verholen F, Smith MR, Fizazi K. Evaluation of Clinically Relevant Drug-Drug Interactions and Population Pharmacokinetics of Darolutamide in Patients with Nonmetastatic Castration-Resistant Prostate Cancer: Results of Pre-Specified and Post Hoc Analyses of the Phase III ARAMIS Trial. Target Oncol. 2019 Oct;14(5):527-539. doi: 10.1007/s11523-019-00674-0.

ReferenceCitation: Fizazi K, Shore N, Tammela TL, Ulys A, Vjaters E, Polyakov S, Jievaltas M, Luz M, Alekseev B, Kuss I, Kappeler C, Snapir A, Sarapohja T, Smith MR; ARAMIS Investigators. Darolutamide in Nonmetastatic, Castration-Resistant Prostate Cancer. N Engl J Med. 2019 Mar 28;380(13):1235-1246. doi: 10.1056/NEJMoa1815671. Epub 2019 Feb 14. Erratum in: N Engl J Med. 2022 Sep 1;387(9):860.

location_country:
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Peru
Belgium
Japan
Romania
South Africa
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Sweden
Slovakia
Brazil
Canada
Hungary
Germany
Bulgaria
Taiwan
Belarus
Latvia
Estonia
Finland
Korea, Republic of
France
Colombia

summary: The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in patients with non-metastatic castration-resistant prostate cancer.


title: An Open-Label Study to Assess the Anti-Tumor Activity and Safety of REGN1979, an Anti CD20 x Anti-CD3 Bispecific Antibody, in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

summary:
Primary objective is to assess the anti-tumor activity of single agent odronextamab as measured by the objective response rate (ORR) according to the Lugano Classification of response in malignant lymphoma (Cheson, 2014) and as assessed by independent central review in each of the following B-cell non-Hodgkin lymphoma (B-NHL) subgroups:

In patients with follicular lymphoma (FL) grade 1-3a *1,2
In patients with diffuse large B-cell lymphoma (DLBCL) *1,2
In patients with mantle cell lymphoma (MCL) that has relapsed after or is refractory to a BTK inhibitor. This cohort will also include patients who have relapsed or have disease refractory to prior systemic therapy, or patients who have demonstrated intolerance to BTK inhibitor therapy, and who have progressed after other systemic therapy.
In patients with marginal zone lymphoma (MZL) *1
In patients with other B-NHL subtypes *1

Secondary objectives are:

To assess the anti-tumor activity of single agent odronextamab in each of 5 disease-specific cohorts, as measured by:
ORR according to the Lugano Classification and as assessed by local investigator evaluation
Complete response (CR) rate according to the Lugano Classification and as assessed local by local investigator evaluation and independent central review
Progression-free survival (PFS)*3
Overall survival (OS)
Duration of response (DOR)*3
Disease control rate (DCR)*3
To evaluate the safety and tolerability of odronextamab
To assess the pharmacokinetics (PK) of odronextamab
To assess the immunogenicity of odronextamab

To assess the effect of odronextamab on patient reported outcomes, including health-related quality of life (HRQL), as measured by the validated instruments European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym), and EuroQoL 5 Dimensions 3 Levels (EQ-5D-3L)

1 that has relapsed after or is refractory to at least 2 prior lines of systemic therapy
2 including an anti-CD20 antibody and an alkylating agent
3 according to Lugano Classification and as assessed by independent central review and local investigator evaluation

status: Recruiting

design_allocation: Non-Randomized

ipd_sharing_description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

lead_sponsor: Regeneron Pharmaceuticals

location_country:
Poland
Taiwan
Spain
Italy
United Kingdom
Australia
Canada
Korea, Republic of
United States
France
China
Singapore
Japan
Germany

location_facility: " University Hospital Kyoto Prefectural University of Medicine"

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

location_facility: National Hospital Organization National Kyushu Cancer Center

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: University/Academic Hospital Mayo Clinic

location_facility: Fundacion Jimenez Diaz University Hospital

location_facility: Fondazione IRCCS Ca' Grande Ospedale Maggiore Policlinico

location_facility: SC Ematologia Dip to Oncologico e Tecnologie Avanzate_ IRCCS - Arcispedale Santa Maria Nuova

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

location_facility: Peking University Cancer Hospital (Beijing Cancer Hospital) (Beijing Institute for Cancer Research)

location_facility: Kobe City Medical Center General Hospital

location_facility: Harbin Medical University Cancer Hospital

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Taipei Medical University - Shuang-Ho Hospital

location_facility: Penninsula & South Eastern Haemotology and Oncology Group

location_facility: Border Medical Oncology, Albury Wodonga Regional Cancer Centre

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

location_facility: Second Affiliated Hospital of Army Medical University, PLA

location_facility: The First Bethune Hospital Of Jilin University

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Sun Yat-Sen University Cancer Center (Cancer Prevention and Treatment Center, Sun Yat-sen University)

location_facility: Tianjin Medical University Cancer Institute & Hospital

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

location_facility: Apteka IHiT (Instytut Hematologii I Transfuzjologii

location_facility: Saitama Medical University International Medical Center

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Japanese Red Cross Nagasaki Genbaku Hospital

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Koo Foundation Sun Yat Sen Cancer Center

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: West China Hospital of Sichuan University

location_facility: Klinikum Chemnitz gGmbH Klinik fuer Innere Medizin III

location_facility: Keimyung University Dongsan Medical Center

location_facility: Hospital Universitario Quiron Salud Madrid

location_facility: Centre Hospitalier Universitaire (CHU) de Poitiers

location_facility: Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

location_facility: Hospital Universitari i Politecnic La Fe

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

location_facility: Klinik fur Innere Medizin II Schwarzwald Baar Klinikum

location_facility: Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

location_facility: John Theurer Cancer Center Hackensack University Medical Center

location_facility: Struttura Complessa di Ematologia e Trapianto di cellule staminali emopoietiche _ IRCCS Casa Sollievo della Sofferenza


title: A Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study With an Open-Label Extension Phase to Confirm Safety and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease

acronym: Clarity AD

summary: This study will be conducted to evaluate the efficacy of lecanemab in participants with early Alzheimer's disease (EAD) by determining the superiority of lecanemab compared with placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment in the Core Study. This study will also evaluate the long-term safety and tolerability of lecanemab in participants with EAD in the Extension Phase and whether the long-term effects of lecanemab as measured by the CDR-SB at the end of the Core Study is maintained over time in the Extension Phase.

ipd_sharing_description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

lead_sponsor: Eisai Inc.

location_country:
Spain
Italy
Russian Federation
Australia
United Kingdom
Canada
Sweden
Korea, Republic of
United States
France
China
Singapore
Japan
Germany

location_facility: Neurological Associates of Tucson dba Center for Neurosciences

location_facility: Universita' Sapienza di Roma - Dipartimento di Neuroscienze Umane

location_facility: Allied Biomedical Research (Clinical Trial)

location_facility: MoCA Clinic and Institute/NeuroSearch Developpements Inc.

location_facility: National Clinical Research Inc.-Richmond

location_facility: North Bay Neuroscience Research Institute

location_facility: Alzheimer's Research and Treatment Center

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

location_facility: Central Adelaide Local Health Network, The Queen Elizabeth Hospital and the Royal Adelaide Hospital

location_facility: Ospedale S. Maria della Misericordia, S. Andrea delle Fratte

location_facility: Sun Yat-Sent Memorial Hospital of Sun Yat-Sen University

location_facility: The Prince Charles Hospital/Internal Medicine & Dementia Research Unit

location_facility: Banner Alzheimer's Institute- Clinical Trials Department

location_facility: HammondCare Malvern Clinical Trials Unit

location_facility: Prima Clinica Neurologica, Primo Policlinico AOU "L. Vanvitelli"

location_facility: Fondazione Policlinico Agostino Gemelli - UCSC

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Kawartha Centre - Redefining Healthy Aging

location_facility: Associated Neurologists of Southern Connecticut

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Seoul National University Boramae Medical Center

location_facility: Emory University Cognitive Neurology Clinic & ADRC

location_facility: Advanced Memory Research Institute of NJ, PC

location_facility: Neuropsychiatric Research Center of Southwest FL

location_facility: ANI Neurology, PLLC d/b/a Alzheimer's Memory Center

location_facility: Xuanwu Hospital Capital Medical University

location_facility: The Second Hospital of Hebei Medical University

location_facility: Institute for Neurodegenerative Disorders

location_facility: Australian Alzheimer's Research Foundation

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Alliance for Multispecialty Research LLC, New Orleans Center for Clinical Research / Volunteer Research Group, an AMR company

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Nanjing Brain Hospital, Affiliated to Nanjing Medical University

location_facility: Clinica Neurologica, IRCCS Ospedale Policlinico San Martino, Genova

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico - U.O.S.D. Malattie Neurodegenerative

location_facility: Recherches Neuro-Hippocampe, Inc., d/b/a Ottawa Memory Clinic

location_facility: True North Clinical Research Halifax, Inc.

location_facility: Butler Hospital - Memory and Aging Program

location_facility: Beijing Tiantan Hospital, Capital Medical University

location_facility: Austin Health - Medical and Cognitive Research Unit

location_facility: Baylor College of Medicine AD and Memory Disorders Center

location_facility: Memory Clinic, Malmö University Hospital

location_facility: Raleigh Neurology Associates, P.A. - Research Department

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Research Center for Clinical Studies, Inc.

location_facility: Seoul National University Bundang Hospital

location_facility: University of Kansas Medical Center Research Institute

location_facility: True North Clinical Research Kentville, Inc.

location_facility: The First Bethune Hospital of Jilin University

location_facility: St Vincent's Hospital - Translational Research Centre

location_facility: Cleveland Clinic Lou Ruvo Center for Brain Health

location_facility: Memory Assessment & Research Centre (MARC),

location_facility: Renji Hospital Shanghai Jiaotong Universtiy School of Medicine

location_facility: Xiangya Hospital Central South University

location_facility: Beijing Friendship Hospital, Capital Medical University

location_facility: New York University Medical Center PRIME

location_facility: First Moscow State Medical University n.a. I.M. Sechenov

location_facility: Centre de Recherche Clinique du Gérontopôle

location_facility: Recherches Neuro-Hippocampe Inc. d/b/a Clinique de la Mémoire de l'Outaouais

location_facility: Toronto Memory Program (Neurology Research Inc.)

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


intervention_type: Biological

title: A Phase 3 Double-blinded, Two-arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) Versus Placebo as Adjuvant Therapy in Participants With Hepatocellular Carcinoma and Complete Radiological Response After Surgical Resection or Local Ablation (KEYNOTE-937)

lead_sponsor: Merck Sharp & Dohme LLC

type: Other Identifier

type: Registry Identifier

ReferenceCitation: Verset G, Borbath I, Karwal M, Verslype C, Van Vlierberghe H, Kardosh A, Zagonel V, Stal P, Sarker D, Palmer DH, Vogel A, Edeline J, Cattan S, Kudo M, Cheng AL, Ogasawara S, Daniele B, Chan SL, Knox JJ, Qin S, Siegel AB, Chisamore M, Hatogai K, Wang A, Finn RS, Zhu AX. Pembrolizumab Monotherapy for Previously Untreated Advanced Hepatocellular Carcinoma: Data from the Open-Label, Phase II KEYNOTE-224 Trial. Clin Cancer Res. 2022 Jun 13;28(12):2547-2554. doi: 10.1158/1078-0432.CCR-21-3807.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
Poland
Hong Kong
Russian Federation
Australia
Argentina
Israel
Turkey
Norway
Malaysia
Sweden
Brazil
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Ireland
New Zealand
Thailand
Korea, Republic of
France

location_facility: Istituto Tumori Giovanni Paolo II ( Site 0543)

location_facility: MTZ Clinical Research Sp. z o. o. ( Site 0608)

location_facility: Taipei Veterans General Hospital ( Site 0331)

location_facility: University of Massachusetts Worcester ( Site 0017)

location_facility: Peking University People's Hospital ( Site 0191)

location_facility: University Malaya Medical Centre ( Site 0288)

location_facility: James Graham Brown Cancer Center ( Site 0088)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0211)

location_facility: Universitaetsklinikum Frankfurt ( Site 0467)

location_facility: Kagawa Prefectural Central Hospital ( Site 0122)

location_facility: Hiroshima University Hospital ( Site 0117)

location_facility: Hospital Universitario de Donostia ( Site 0671)

location_facility: Princess Alexandra Hospital ( Site 0228)

location_facility: St Vincents Hospital Melbourne ( Site 0227)

location_facility: Fundación favaloro para la Docencia e Investigación Médica ( Site 0808)

location_facility: Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0828)

location_facility: Saitama Medical University Hospital ( Site 0104)

location_facility: Hospital Universiti Sains Malaysia ( Site 0295)

location_facility: National Cheng Kung University Hospital ( Site 0334)

location_facility: University of Cincinnati Medical Center ( Site 0084)

location_facility: Hopital Claude Huriez CHRU LILLE ( Site 0440)

location_facility: Affiliated Tumor Hospital of Xinjiang Medical University ( Site 0157)

location_facility: First Moscow State Medical University n.a. I.M.Sechenov ( Site 0661)

location_facility: Izerskie Centrum Pulmonologii i Chemioterapii IZER-MED Spolka z o.o. ( Site 0607)

location_facility: Hospital Central de Asturias ( Site 0667)

location_facility: National Cancer Institute of the MoH of Ukraine ( Site 0779)

location_facility: Anhui Provincil Hospital South District ( Site 0181)

location_facility: Namik Kemal Universitesi Tip Fakultesi ( Site 0738)

location_facility: Hospital Britanico de Buenos Aires ( Site 0792)

location_facility: Hospital de Cancer de Pernambuco ( Site 0815)

location_facility: Norrlands Universitetssjukhus ( Site 0687)

location_facility: The Beatson West of Scotland Cancer Centre ( Site 0750)

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0757)

location_facility: University Medical Center New Orleans ( Site 0014)

location_facility: CI City Clinical Hospital # 3 ( Site 0783)

location_facility: Universitatsklinikum Carl Gustav Carus ( Site 0459)

location_facility: Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0174)

location_facility: Hospital Universitari Parc Tauli ( Site 0681)

location_facility: Complex Cancer Center Plovdiv-First Medical Oncology Department ( Site 0982)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0826)

location_facility: Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 0102)

location_facility: CHUV (centre hospitalier universitaire vaudois) ( Site 0712)

location_facility: Shalimov s NI of Surgery and Transplantation ( Site 0781)

location_facility: University Hospital Antwerp (UZA) ( Site 0374)

location_facility: Pamela Youde Nethersole Eastern Hospital ( Site 0271)

location_facility: Japanese Red Cross Osaka Hospital ( Site 0113)

location_facility: Yokohama City University Medical Center ( Site 0110)

location_facility: Nova Scotia Health Authority QEII-HSC ( Site 0208)

location_facility: Sahlgrenska Universitetssjukhuset ( Site 0691)

location_facility: Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0335)

location_facility: City Clinical Oncology Center ( Site 0646)

location_facility: Staedtisches Klinikum Dresden ( Site 0471)

location_facility: Institut Kanser Negara - National Cancer Institute ( Site 0294)

location_facility: Fujian Provincial Cancer Hospital ( Site 0165)

location_facility: Haddassah Medical Organization - Ein Kerem ( Site 0519)

location_facility: Regional Clinical Onco Dispensary_ State Medical University ( Site 0782)

location_facility: Virginia Mason Medical Center ( Site 0028)

location_facility: Gulhane Egitim ve Arastirma Hastanesi ( Site 0741)

location_facility: Altay Regional Oncology Dispensary ( Site 0919)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0540)

location_facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 0483)

location_facility: The University of Tokyo Hospital ( Site 0105)

location_facility: Klinikum rechts der Isar der Technischen Universitaet ( Site 0470)

location_facility: The Third Xiangya Hospital of Central South University ( Site 0167)

location_facility: Debreceni Egyetem Klinikai Kozpont Onkologiai Tanszek ( Site 0481)

location_facility: Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0604)

location_facility: The University of Arizona Cancer Center - North Campus ( Site 0039)

location_facility: Hospital Universitario Puerta de Hierro ( Site 0678)

location_facility: Hospital Universitario Miguel Servet-Gastroenterology ( Site 0682)

location_facility: Inonu University Faculty of Medicine ( Site 0729)

location_facility: West China Hospital of Sichuan University ( Site 0162)

location_facility: The First Affiliated Hospital of Xi an Jiaotong University ( Site 0164)

location_facility: Royal Prince Alfred Hospital AW ( Site 0225)

location_facility: Hospital de Clinicas de Porto Alegre ( Site 0824)

location_facility: Zhongshan Hospital affiliated to Fudan University ( Site 0153)

location_facility: Aarhus Universitets hospital ( Site 0420)

location_facility: Musashino Red Cross Hospital ( Site 0107)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 0676)

location_facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 0469)

location_facility: Azienda Ospedaliero Universitaria Careggi ( Site 0549)

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello ( Site 0547)

location_facility: Saga-Ken Medical Centre Koseikan ( Site 0120)

location_facility: SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 0606)

location_facility: Southern Medical University Nanfang Hospital ( Site 0172)

location_facility: Universitaetsklinikum Duesseldorf ( Site 0461)

location_facility: Samara Regional Clinical Oncology Center ( Site 0656)

location_facility: Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 0550)

location_facility: Russian Scientific Center of Radiology and Surgical Technologies ( Site 0665)

location_facility: Hadassah Medical-Clinical Research Department ( Site 0920)

location_facility: Bezmialem Vakif University School of Medicine ( Site 0732)

location_facility: Beth Israel Deaconess Medical Ctr. ( Site 0033)

location_facility: Universitaetsklinikum Wuerzburg ( Site 0468)

location_facility: Baylor Scott & White Medical Center - Temple ( Site 0089)

location_facility: Universitaetsklinikum Koeln ( Site 0463)

location_facility: Nottingham University Hospitals NHS Trust ( Site 0756)

location_facility: Banner MD Anderson Cancer Center ( Site 0026)

location_facility: Chang Gung Medical Foundation. Linkou ( Site 0332)

location_facility: Seoul National University Bundang Hospital ( Site 0313)

location_facility: Oslo Universitetssykehus HF. Ulleval ( Site 0433)

location_facility: Azienda Ospedaliera Ordine Mauriziano di Torino ( Site 0542)

location_facility: Leeds Teaching Hospitals NHS Trust ( Site 0751)

location_facility: Konya Necmettin Erbakan University Medical Faculty ( Site 0736)

location_facility: Hospital Provincial del Centenario ( Site 0794)

location_facility: Road Hospital JSC Russian railways ( Site 0649)

location_facility: Indiana University Simon Cancer Center ( Site 0075)

location_facility: Hunan Provincial People Hospital ( Site 0192)

location_facility: Siberian Clinical Center of FMBA ( Site 0918)

location_facility: McGill University Health Centre ( Site 0207)

location_facility: National Hospital Organization Kyushu Medical Center ( Site 0118)

location_facility: National Taiwan University Hospital ( Site 0330)

location_facility: Osaka Metropolitan University Hospital. ( Site 0114)

location_facility: Massachusetts General Hospital ( Site 0062)

location_facility: Tomsk Scientific Research Institute of Oncology ( Site 0657)

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie ( Site 0620)

location_facility: China Medical University Hospital ( Site 0333)

location_facility: Regional Oncology Center of Kharkiv ( Site 0777)

location_facility: Charite - Campus Virchow Klinikum ( Site 0457)

location_facility: Zhongshan Hospital Fudan University ( Site 0193)

location_facility: Fudan University Shanghai Cancer Center ( Site 0161)

location_facility: Cancer Hospital Chinese Academy of Medical Sciences ( Site 0156)

location_facility: University Hospital, Kyoto Prefectural University of Medicine ( Site 0112)

location_facility: City Clinical Hospital 1 na. NI. Pirogov ( Site 0662)

location_facility: SLK-Kliniken Heilbronn GmbH ( Site 0460)

location_facility: SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 0482)

location_facility: Kings College Hospital NHS Foundation Trust ( Site 0758)

location_facility: University Hospital Coventry and Warwickshire NHS Trust ( Site 0754)

location_facility: Tallaght University Hospital ( Site 0499)

location_facility: St Vincent's University Hospital ( Site 0498)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0730)

location_facility: Medical Center Dobrobut Clinic ( Site 0785)

location_facility: Toranomon Hospital Kajigaya ( Site 0109)

location_facility: Adnan Menderes University Medical Faculty ( Site 0737)

location_facility: Miami Valley Hospital South ( Site 0093)

location_facility: Hospital Universitario Austral ( Site 0795)

location_facility: Seoul National University Hospital ( Site 0312)

location_facility: CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0813)

location_facility: Karolinska Universitetssjukhuset, Huddinge ( Site 0689)

location_facility: Blokhin National Medical Oncology ( Site 0645)

location_facility: Cambridge University Hospitals NHS Trust ( Site 0755)

location_facility: Complejo Hospitalario Universitario de Santiago ( Site 0668)

location_facility: Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0820)

location_facility: Azienda Ospedaliero Universitaria Pisana ( Site 0546)

location_facility: City of Hope Medical Center ( Site 0027)

location_facility: Wakayama Medical University Hospital ( Site 0115)

location_facility: Universitaetsklinikum Tuebingen ( Site 0466)

location_facility: Baskent Unv. Adana Uyg. ve Arast. Hastanesi ( Site 0733)

location_facility: Medizinische Hochschule Hannover ( Site 0458)

location_facility: Kanazawa University Hospital ( Site 0111)

location_facility: North Shore-Long Island Jewish Health System ( Site 0068)

location_facility: The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0315)

location_facility: Henry Ford Hospital-GI/Hepatology Research ( Site 0047)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0648)

location_facility: Severance Hospital Yonsei University Health System ( Site 0309)

location_facility: Smilow Cancer Hospital at Yale New Haven ( Site 0042)

location_facility: Instituto COI de Pesquisa Educacao e Gestao ( Site 0825)

location_facility: MI Odessa Regional Oncological Centre ( Site 0776)

location_facility: A O U Policlinico di Modena ( Site 0548)

location_facility: AOU di Bologna Policliico S. Orsola-Malpighi ( Site 0541)

location_facility: National Medical Research Radiological Centre ( Site 0660)

location_facility: Odense Universitets Hospital ( Site 0422)

location_facility: Privolzhsky District Medical Center ( Site 0655)

location_facility: Clinica de nefrologia urologia y enfermedades cardiovasculares ( Site 0802)

location_facility: Clinica de Oncologia Reichow ( Site 0818)

location_facility: Hospital Universitario Virgen del Rocio ( Site 0670)

location_facility: Maharaj Nakorn Chiangmai Hospital ( Site 0353)

location_facility: Hospital Universitario La Paz ( Site 0677)

location_facility: Casa de Saude Santa Marcelina ( Site 0821)

location_facility: Universal Clinic Oberig-Oncology Center ( Site 0786)

location_facility: Hopitaux Universitaires de Geneve HUG ( Site 0711)

location_facility: Hospital Universitari Vall d Hebron ( Site 0674)

location_facility: Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 0484)

location_facility: Vanderbilt Ingram Cancer Center ( Site 0006)

summary: This study will evaluate the safety and efficacy of pembrolizumab (MK-3475) versus placebo as adjuvant therapy in participants with hepatocellular carcinoma (HCC) and complete radiological response after surgical resection or local ablation. The primary hypotheses of this study are that adjuvant pembrolizumab is superior to placebo with respect to: 1) recurrence-free survival (RFS) as assessed by blinded independent central review (BICR); and 2) overall survival (OS).


title: A Phase II Randomized, Double-blinded, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of BI 425809 Once Daily With Adjunctive Computerized Cognitive Training Over 12 Week Treatment Period in Patients With Schizophrenia

summary:
This is a study in adults with schizophrenia. The study tests whether a medicine called BI 425809 together with brain training improves mental abilities.

Participants take study medication once a day for 12 weeks. At the start of the study, the participants are put into 2 groups. It is decided by chance who gets into which group. One group gets BI 425809 tablets every day. The other group gets placebo tablets every day. Placebo tablets look like the BI 425809 tablets, but contain no medicine. During the study, all participants do brain training using a computer.

The doctors regularly test mental abilities of the participants. The results of the mental ability tests are compared between the groups. The doctors also check the general health of the patients.

ReferenceCitation: Harvey PD, Bowie CR, McDonald S, Podhorna J. Evaluation of the Efficacy of BI 425809 Pharmacotherapy in Patients with Schizophrenia Receiving Computerized Cognitive Training: Methodology for a Double-blind, Randomized, Parallel-group Trial. Clin Drug Investig. 2020 Apr;40(4):377-385. doi: 10.1007/s40261-020-00893-8.

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:
United Kingdom
New Zealand
Australia
Canada
United States
France

location_facility: Jerome Golden Center for Behavioral Health

location_facility: Monash Alfred Psychiatry Research Centre

location_facility: Collaborative Neuroscience Network, LLC (CNS)

location_facility: IUSMM Institut Universitaire en Sante Mentale de Montreal

location_facility: BC Mental Health and Addictions Research Institute (University of British Columbia)

location_facility: Centre for Addiction and Mental Health (CAMH)

location_facility: UNC Center for Excellence in Community Mental Health, North Carolina Psychiatric Research Center


title: AXITINIB IN ADVANCED / METASTATIC RENAL CELL CARCINOMA - A NON-INTERVENTIONAL STUDY OF REAL WORLD TREATMENT OUTCOMES IN PATIENTS RECEIVING 2ND LINE AXITINIB AFTER 1ST LINE SUNITINIB (ADONIS)

acronym: ADONIS

summary: This is an international, multi-centre, prospective (partly retrospective), observational study to evaluate treatment patterns and clinical outcomes in patients with advanced or metastatic RCC treated with sunitinib in first line and/or receiving axitinib in second line post sunitinib. The study is designed to enroll approximately 750 patients over the course of an enrollment period of approximately 36 months.

study_type: Observational

time_perspective: Other

ipd_sharing: No

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
Spain
Italy
Austria
Greece
United Kingdom
France
Belgium
Netherlands

location_facility: Institut Sainte Catherine, Department Oncologie, Medecine Interene

location_facility: Universitasklinik für Urologie und Andrologie

location_facility: Centre Hospitalier De Bourg En Bresse - Hopital Fleyriat

location_facility: Algemeen Ziekenhuis Sint-Lucas, Dienst Oncologie

location_facility: Hospital Clinico Universitario de Valencia

location_facility: H. U. de Vigo- Hospital Álvaro Cunqueiro/Servicio de Oncologia Medica

location_facility: Divisione di Oncologia, AORN Antonio Cardarelli

location_facility: Groupe Hospitalier Intercommunal le Raincy Montfermeil

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Centro Sanitario Hospital Universitario y Politecnico La Fe

location_facility: Hopital de Hautepierre-Service Oncologie at Hematologie

location_facility: Institut Catala Oncologia - Hospital Universitari de Girona Dr Josep Trueta

location_facility: Istituto Nazionale Tumori, Oncologia Medica B

location_facility: C.H.G. Antoine Gayraud, Medecine Interne

location_facility: Centre Antoine Lacassagne, Service d'Oncologie

location_facility: Centre Rene Gauducheau - Service Oncologie Medicale

location_facility: Complexo Hospitalario Universitario A Coruña. Hospital Teresa Herrera

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

location_facility: Hospital General Universitario de Alicante

location_facility: Krankenhaus der Barmherzigen Schwestern Linz Abteilung fuer Urologie

location_facility: Royal Marsden Hospital, Royal Marsden NHS Foundation Trust

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Centre d'Oncologie et de Radiotherapie du pays Basque

location_facility: Cl Armoricaine Radiologie / Radiotherapie

location_facility: AKH - Universitaetsklinik fuer Innere Medizin I

location_facility: Centre Hospitalier Lyon Sud - Service d oncologie medicale

location_facility: General Hospital of Chest Diseases of Athens "Sotiria"

location_facility: Hopital Jean BERNARD - Tours - 7eme etage

location_facility: Divisione di Oncologia Medica, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: AKH-Universitat Klinik fur Innere Medizin I

intervention_type: Other


title: A Phase 2a, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of EYP001a in Patients With Nonalcoholic Steatohepatitis

lead_sponsor: Enyo Pharma

ReferenceCitation: Ratziu V, Harrison SA, Loustaud-Ratti V, Bureau C, Lawitz E, Abdelmalek M, Alkhouri N, Francque S, Girma H, Darteil R, Couchoux H, Wolf M, Sanyal A, Vonderscher J, Scalfaro P. Hepatic and renal improvements with FXR agonist vonafexor in individuals with suspected fibrotic NASH. J Hepatol. 2022 Nov 2. pii: S0168-8278(22)03160-9. doi: 10.1016/j.jhep.2022.10.023. [Epub ahead of print]

location_country:
United Kingdom
Puerto Rico
United States
France
Belgium

location_facility:
ENYO PHARMA Investigative site 0304
ENYO PHARMA Investigative site 0419
ENYO PHARMA Investigative site 0411
ENYO PHARMA Investigative site 0412
ENYO PHARMA Investigative site 0105
ENYO PHARMA Investigative site 0103
ENYO PHARMA Investigative site 0407
ENYO PHARMA Investigative site 0409
ENYO PHARMA Investigative site 0207
ENYO PHARMA Investigative site 0422
ENYO PHARMA Investigative site 0401
ENYO PHARMA Investigative site 0205
ENYO PHARMA Investigative site 0203
ENYO PHARMA Investigative site 0402
ENYO PHARMA Investigative site 0414
ENYO PHARMA Investigative site 0415
ENYO PHARMA Investigative site 0101
ENYO PHARMA Investigative site 0421
ENYO PHARMA Investigative site 0416
ENYO PHARMA Investigative site 0302
ENYO PHARMA Investigative site 0202
ENYO PHARMA Investigative site 0301
ENYO PHARMA Investigative site 0417
ENYO PHARMA Investigative site 0303
ENYO PHARMA Investigative site 0406
ENYO PHARMA Investigative site 0204
ENYO PHARMA Investigative site 0410
ENYO PHARMA Investigative site 0424
ENYO PHARMA Investigative site 0201
ENYO PHARMA Investigative site 0404
ENYO PHARMA Investigative site 0403
ENYO PHARMA Investigative site 0423
ENYO PHARMA Investigative site 0429
ENYO PHARMA Investigative site 0413
ENYO PHARMA Investigative site 0104
ENYO PHARMA Investigative site
ENYO PHARMA Investigative site 0305
ENYO PHARMA Investigative site 0206
ENYO PHARMA Investigative site 0418
ENYO PHARMA Investigative site 0405
ENYO PHARMA Investigative site 0420
ENYO PHARMA Investigative site 0408

summary: The purpose of this study is to assess the effects of EYP001a with respect to safety, tolerability, pharmacokinetics and on markers of liver inflammation in patients with NASH


title: An Eighteen-Month, 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 Macular Edema Secondary to Branch Retinal Vein Occlusion

acronym: RAPTOR

summary: The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of patients with macular edema (ME) secondary to branch retinal vein occlusion (BRVO).

status: Terminated

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 www.clinicalstudydatarequest.com

lead_sponsor: Novartis Pharmaceuticals

location_country:
Denmark
Taiwan
Hong Kong
Spain
Italy
Austria
Russian Federation
United Kingdom
Canada
Switzerland
Puerto Rico
United States
France
China
Israel
Japan
Germany
Slovakia
Czechia

status_simplified: Unknown


acronym: COSMOS

title: Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Alpha (Anti-TNFα) Therapy

lead_sponsor: Janssen Pharmaceutica N.V., Belgium

ReferenceCitation: Coates LC, Gossec L, Theander E, Bergmans P, Neuhold M, Karyekar CS, Shawi M, Noël W, Schett G, McInnes IB. Efficacy and safety of guselkumab in patients with active psoriatic arthritis who are inadequate responders to tumour necrosis factor inhibitors: results through one year of a phase IIIb, randomised, controlled study (COSMOS). Ann Rheum Dis. 2022 Mar;81(3):359-369. doi: 10.1136/annrheumdis-2021-220991. Epub 2021 Nov 24.

ipd_sharing_description:
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials\transparency.

As noted on this site, requests for access to the study data can be submitted through Yale open Access (YODA) Project site at yoda.yale.edu

location_country:
Poland
Portugal
Spain
Greece
Italy
Russian Federation
United Kingdom
Ukraine
Hungary
France
Israel
Belgium
Germany
Bulgaria

location_facility: Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv

location_facility: Barts Health NHS Trust Whipps Cross University Hospital NHS Trust

location_facility: Diagnostic - Consulting Center II-Pleven

location_facility: Municipal Non-commercial Enterprise 'Ternopil University Hospital' of Ternopil Regional Council

location_facility: Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital

location_facility: Samara Regional Clinical Hospital Named After V.D.Seredavin

location_facility: WroMedica I.Bielicka, A.Strzałkowska s.c.

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktatokorhaz

location_facility: ME 'Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil'

location_facility: Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz

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

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Guy's and St Thomas' NHS Foundation Trust - Rheumatoid Arthritis (RA) Clinic

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: Tula Regional Clinical Dermatovenerological Dispensary

location_facility: Centrum Terapii Wspolczesnej J. M. Jasnorzewska J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

location_facility: Communal Noncommercial Enterprise 'Cherkasy Regional Hospital of Cherkasy Regional Council'

location_facility: Ivano-Frankivsk National Medical University, Ivano-Frankivsk City Clinical Hospital

location_facility: City Multifield Hospital #18, Mechnikov Institute of Microbiology and Immunology of NAMS

location_facility: Hopital Pellegrin Tripode - CHU de Bordeaux

location_facility: Medical Center LTD Health Clinic Department of Cardiology and Rheumatology

location_facility: Multiprofile Hospital for Active Treatment - Plovdiv

location_facility: Ryazan Regional Clinical Dermatovenerological Dispensary

location_facility: SI 'National Scientific Center Institute of Cardiology of M.D. Strazhesko' of NAMS of Ukraine

location_facility: Royal National Hospital for Rheumatic Diseases

location_facility: Municipal institution Central Clinical Hospital #1 Zhytomir

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz

location_facility: Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source

location_facility: Republican Clinical Hospital - G.G. Kuvatov

location_facility: Kyiv City Clinical Hospital #3, National Medical University

location_facility: Smolensk regional hospital on Smolensk railway station

location_facility: Vital Medical Center Orvosi es Fogaszati Kozpont

location_facility: Rostov Regional Clinical Dermatovenerological Dispensary

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

location_facility: Mazowieckie Centrum Reumatologii i Osteoporozy

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

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Purpan

location_facility: Krasnodar Clinical Dermatovenerologic Dispensary

location_facility: Kyiv Railway Station Clinical Hospital #2

location_facility: VNMUn.af.Pyrogova,CNE Vinnytsia Regional Clinical Hospital n.af.Pyrogova Vinnytsia Regional Council

summary: The purpose of this study is to evaluate guselkumab efficacy versus placebo in participants with active psoriatic arthritis (PsA) and an inadequate response to Anti-Tumor Necrosis Factor Alpha (TNF-alpha) therapy by assessing the reduction in signs and symptoms of joint disease.


title: An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination With PD1 Blockade in Patients With Solid Tumors

acronym: IGNYTE

summary: RPL-001-16 is a Phase 1/2, open label, dose escalation and expansion clinical study of RP1 alone and in combination with nivolumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.

ReferenceCitation: Thomas S, Kuncheria L, Roulstone V, Kyula JN, Mansfield D, Bommareddy PK, Smith H, Kaufman HL, Harrington KJ, Coffin RS. Development of a new fusion-enhanced oncolytic immunotherapy platform based on herpes simplex virus type 1. J Immunother Cancer. 2019 Aug 10;7(1):214. doi: 10.1186/s40425-019-0682-1.

ipd_sharing: Undecided

lead_sponsor: Replimune Inc.

location_country:
United Kingdom
Spain
United States
France
Germany

location_facility: University Hospital Essen, Klinik für Dermatologie

location_facility: Hospital General Universitario de Valencia

location_facility: Institut Catala D'Oncologia - Hospital Duran I

location_facility: Service de Dermatologie et Cancerologie Cutanee Hopital de la Timone

location_facility: University of Kiel (UKSH), Dep. of Dermatology

location_facility: University of Iowa-Cancer Center Research

location_facility: Seattle Cancer Care Alliance- University of Washington

location_facility: James Graham Brown Cancer Center- University of Louisville

location_facility: University of Wisconsin-Carbone Cancer Center

location_facility: Intermountain Cancer Center- Saint George Cancer Center

location_facility: Eccles Outpatient Care Center- Oncology Clinical Trials

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: New York University Clinical Cancer Center

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Sylvester Comprehensive Cancer Center- University of Miami


title: Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as Add on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes

acronym: SUSTAIN™ 4

summary: This trial is conducted in Africa, North and South America, Asia and Europe. The purpose of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in insulin-naïve subjects with type 2 diabetes.

ReferenceType: background

ReferenceCitation: Rodbard HW, Bellary S, Hramiak I, Seino Y, Silver R, Damgaard LH, Nayak G, Zacho J, Aroda VR. GREATER COMBINED REDUCTIONS IN HbA(1C) ≥1.0% AND WEIGHT ≥5.0% WITH SEMAGLUTIDE VERSUS COMPARATORS IN TYPE 2 DIABETES. Endocr Pract. 2019 Jun;25(6):589-597. doi: 10.4158/EP-2018-0444. Epub 2019 Mar 13.

ReferenceType: result

ReferenceCitation: Aroda VR, Bain SC, Cariou B, Piletič M, Rose L, Axelsen M, Rowe E, DeVries JH. Efficacy and safety of once-weekly semaglutide versus once-daily insulin glargine as add-on to metformin (with or without sulfonylureas) in insulin-naive patients with type 2 diabetes (SUSTAIN 4): a randomised, open-label, parallel-group, multicentre, multinational, phase 3a trial. Lancet Diabetes Endocrinol. 2017 May;5(5):355-366. doi: 10.1016/S2213-8587(17)30085-2. Epub 2017 Mar 23.

ReferenceCitation: Kapitza C, Dahl K, Jacobsen JB, Axelsen MB, Flint A. Effects of semaglutide on beta cell function and glycaemic control in participants with type 2 diabetes: a randomised, double-blind, placebo-controlled trial. Diabetologia. 2017 Aug;60(8):1390-1399. doi: 10.1007/s00125-017-4289-0. Epub 2017 May 19.

ReferenceCitation: Warren M, Chaykin L, Trachtenbarg D, Nayak G, Wijayasinghe N, Cariou B. Semaglutide as a therapeutic option for elderly patients with type 2 diabetes: Pooled analysis of the SUSTAIN 1-5 trials. Diabetes Obes Metab. 2018 Sep;20(9):2291-2297. doi: 10.1111/dom.13331. Epub 2018 Jun 7.

ReferenceCitation: Ahrén B, Atkin SL, Charpentier G, Warren ML, Wilding JPH, Birch S, Holst AG, Leiter LA. Semaglutide induces weight loss in subjects with type 2 diabetes regardless of baseline BMI or gastrointestinal adverse events in the SUSTAIN 1 to 5 trials. Diabetes Obes Metab. 2018 Sep;20(9):2210-2219. doi: 10.1111/dom.13353. Epub 2018 Jun 12.

ReferenceCitation: DeVries JH, Desouza C, Bellary S, Unger J, Hansen OKH, Zacho J, Woo V. Achieving glycaemic control without weight gain, hypoglycaemia, or gastrointestinal adverse events in type 2 diabetes in the SUSTAIN clinical trial programme. Diabetes Obes Metab. 2018 Oct;20(10):2426-2434. doi: 10.1111/dom.13396. Epub 2018 Jul 9.

ReferenceCitation: Aroda VR, Ahmann A, Cariou B, Chow F, Davies MJ, Jódar E, Mehta R, Woo V, Lingvay I. Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes: Insights from the SUSTAIN 1-7 trials. Diabetes Metab. 2019 Oct;45(5):409-418. doi: 10.1016/j.diabet.2018.12.001. Epub 2019 Jan 4. Review.

ReferenceCitation: Husain M, Bain SC, Holst AG, Mark T, Rasmussen S, Lingvay I. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Cardiovasc Diabetol. 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4.

ReferenceCitation: Capehorn M, Ghani Y, Hindsberger C, Johansen P, Jódar E. Once-Weekly Semaglutide Reduces HbA(1c) and Body Weight in Patients with Type 2 Diabetes Regardless of Background Common OAD: a Subgroup Analysis from SUSTAIN 2-4 and 10. Diabetes Ther. 2020 May;11(5):1061-1075. doi: 10.1007/s13300-020-00796-z. Epub 2020 Mar 19.

ReferenceCitation: Husain M, Bain SC, Jeppesen OK, Lingvay I, Sørrig R, Treppendahl MB, Vilsbøll T. Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk. Diabetes Obes Metab. 2020 Mar;22(3):442-451. doi: 10.1111/dom.13955. Epub 2020 Feb 5.

ReferenceCitation: DeSouza C, Cariou B, Garg S, Lausvig N, Navarria A, Fonseca V. Efficacy and Safety of Semaglutide for Type 2 Diabetes by Race and Ethnicity: A Post Hoc Analysis of the SUSTAIN Trials. J Clin Endocrinol Metab. 2020 Feb 1;105(2). pii: dgz072. doi: 10.1210/clinem/dgz072.

ReferenceCitation: Jendle J, Birkenfeld AL, Polonsky WH, Silver R, Uusinarkaus K, Hansen T, Håkan-Bloch J, Tadayon S, Davies MJ. Improved treatment satisfaction in patients with type 2 diabetes treated with once-weekly semaglutide in the SUSTAIN trials. Diabetes Obes Metab. 2019 Oct;21(10):2315-2326. doi: 10.1111/dom.13816. Epub 2019 Jul 12.

lead_sponsor: Novo Nordisk A/S

location_country:
Croatia
Romania
Slovenia
United Kingdom
Netherlands
Argentina
North Macedonia
Puerto Rico
United States
France
India
South Africa
Mexico
Germany
Slovakia


title: Sub-cutaneous Rituximab-miniCHOP Versus Sub-cutaneous Rituximab-miniCHOP + Lenalidomide (R2-miniCHOP) in Diffuse Large B Cell Lymphoma for Patients of 80 Years Old or More. A Multicentric Phase III Study of the LYSA Association

summary: The purpose of this study is to compare the efficacy of R2-miniCHOP (Sub-cutaneous Rituximab-miniCHOP + lenalidomide) and R-miniCHOP (Sub-cutaneous Rituximab-miniCHOP) in patients aged 80 years old or more with not previously treated cluster of differentiation antigen 20 positive (CD20+) diffuse large B-cell lymphoma as measured by the overall survival (OS).The SENIOR trial will evaluate the tolerance and efficacy of the combination of the R2-miniCHOP regimen and compare this experimental arm to the standard R-miniCHOP regimen.The statistical plan is based on the hypothesis of an increase by 15% of the 2y-OS in favor of the experimental arm, as compared to the reference arm (R-miniCHOP).

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: France Belgium

location_facility: Université Catholique de Louvain Saint Luc


title: A Long-term Follow up Study to Evaluate the Safety and Efficacy in Transplant Recipients Treated With Modified Release Tacrolimus, FK506E (MR4), Based Immunosuppression Regimen

summary: The purpose of this study was to offer patients who had participated in one of the phase II PK or phase III studies on FK506E (MR4) the possibility to continue FK506E (MR4) until commercial availability of the drug and to record long term efficacy and safety data.

ipd_sharing_description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

lead_sponsor: Astellas Pharma Europe Ltd.

location_country:
Spain
Italy
United Kingdom
United States
South Africa
Belgium
Czechia
Poland
Austria
Australia
Mexico
Sweden
Brazil
Canada
Switzerland
Hungary
Germany
Denmark
Ireland
New Zealand
Finland
France
Netherlands

location_facility: Vancouver Hospital & Health Sciences Centre

location_facility: Hospital General Universitario Gregorio Maranón

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Univ. Klinik und Poliklinik fuer Urologie

location_facility: University of Stellenbosch, Tygerberg Hospital

location_facility: Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: Azienda Ospedaliera Policlinico di Modena

location_facility: Unita Operativa Trapianto di Fegato e Multiorgano

location_facility: Centre Hospitalier de l'Universite de Montreal (CHUM)

location_facility: Unita Operativa Complessa di Chirurgia dei Trapianti

location_facility: Instituto Mexicano de Transplantes Cuernava

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Azienda Ospedaliera Ospedale Maggiore di Milano


title: Phase 3B, Randomized Trail of Revlimid® (Lenalidomide) Versus Placebo Maintenance Therapy Following Melphalan Prednisone Velcade (Bortezomib) Induction Therapy In Newly Diagnosed Multiple Myeloma

acronym: ARUMM

summary:
The purpose of this study is to compare the safety and efficacy of Lenalidomide versus Placebo maintenance following melphalan, prednisone and velcade induction therapy in newly diagnosed multiple myeloma.

After the study is unblinded, subjects in treatment Arm A (Len 10 mg) will remain on study therapy at the Investigator's discretion and subjects in treatment Arm B (placebo), will be discontinued from study treatment. Subjects who discontinued from study treatment for any reason will enter the LTFU Phase.

ReferenceCitation: Ailawadhi S, Jacobus S, Sexton R, Stewart AK, Dispenzieri A, Hussein MA, Zonder JA, Crowley J, Hoering A, Barlogie B, Orlowski RZ, Rajkumar SV. Disease and outcome disparities in multiple myeloma: exploring the role of race/ethnicity in the Cooperative Group clinical trials. Blood Cancer J. 2018 Jul 6;8(7):67. doi: 10.1038/s41408-018-0102-7.

ReferenceCitation: Dumontet C, Hulin C, Dimopoulos MA, Belch A, Dispenzieri A, Ludwig H, Rodon P, Van Droogenbroeck J, Qiu L, Cavo M, Van de Velde A, Lahuerta JJ, Allangba O, Lee JH, Boyle E, Perrot A, Moreau P, Manier S, Attal M, Roussel M, Mohty M, Mary JY, Civet A, Costa B, Tinel A, Gaston-Mathé Y, Facon T. A predictive model for risk of early grade ≥ 3 infection in patients with multiple myeloma not eligible for transplant: analysis of the FIRST trial. Leukemia. 2018 Jun;32(6):1404-1413. doi: 10.1038/s41375-018-0133-x. Epub 2018 Apr 26.

ReferenceCitation: Jain T, Sonbol MB, Firwana B, Kolla KR, Almader-Douglas D, Palmer J, Fonseca R. High-Dose Chemotherapy with Early Autologous Stem Cell Transplantation Compared to Standard Dose Chemotherapy or Delayed Transplantation in Patients with Newly Diagnosed Multiple Myeloma: A Systematic Review and Meta-Analysis. Biol Blood Marrow Transplant. 2019 Feb;25(2):239-247. doi: 10.1016/j.bbmt.2018.09.021. Epub 2018 Sep 20.

ReferenceCitation: Gambella M, Omedé P, Spada S, Muccio VE, Gilestro M, Saraci E, Grammatico S, Larocca A, Conticello C, Bernardini A, Gamberi B, Troia R, Liberati AM, Offidani M, Rocci A, Palumbo A, Cavo M, Sonneveld P, Boccadoro M, Oliva S. Minimal residual disease by flow cytometry and allelic-specific oligonucleotide real-time quantitative polymerase chain reaction in patients with myeloma receiving lenalidomide maintenance: A pooled analysis. Cancer. 2019 Mar 1;125(5):750-760. doi: 10.1002/cncr.31854. Epub 2018 Dec 18.

ReferenceCitation: Pegourie B, Karlin L, Benboubker L, Orsini-Piocelle F, Tiab M, Auger-Quittet S, Rodon P, Royer B, Leleu X, Bareau B, Cliquennois M, Fuzibet JG, Voog E, Belhadj-Merzoug K, Decaux O, Rey P, Slama B, Leyronnas C, Zarnitsky C, Boyle E, Bosson JL, Pernod G; IFM Group. Apixaban for the prevention of thromboembolism in immunomodulatory-treated myeloma patients: Myelaxat, a phase 2 pilot study. Am J Hematol. 2019 Jun;94(6):635-640. doi: 10.1002/ajh.25459. Epub 2019 Apr 1.

lead_sponsor: Celgene

location_country: Spain Italy Greece France Belgium

location_facility: Institut Universitaire du Cancer IUCT - Oncopole

location_facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale

location_facility: Centre Hospitalier de la Region d'Annecy

location_facility: Ematologia ed Immunologia, Azienda Ospedaliera Vito Fazzi di Lecce

location_facility: Dipartimento Medicina ed Oncologia Sperimentale - Divisione Universitaria di Ematologia Azienda Ospe

location_facility: Unità Operativa di Oncoematologia, Ospedale di Matera

location_facility: Cliniques Universitaires UCL de Mont-Godine

location_facility: Theagenio Anticancer Hospital of Thessaloniki

location_facility: Clinica Ematologica, A.O.U. San Martino di Genova

location_facility: U.O. di Ematologia e Trapianto di Midollo Osseo

location_facility: Centre Hospitalier Sud Francilien - Site Gilles de Corbeil

location_facility: Centre Hospitalier EpiCURA - Clinique Louis Caty de Baudour

location_facility: Policlinico San Matteo Universita Di Pavia

location_facility: Centre Hospitalier Regional Metz-Thionville Hopital de Mercy


title: Treatment of Brain AVMs (TOBAS) Study: A Randomized Controlled Trial and Registry

acronym: TOBAS

summary:
The objectives of this study and registry are to offer the best management possible for patients with brain arteriovenous malformations (AVMs) (ruptured or unruptured) in terms of long-term outcomes, despite the presence of uncertainty. Management may include interventional therapy (with endovascular procedures, neurosurgery, or radiotherapy, alone or in combination) or conservative management.

The trial has been designed to test a) whether medical management or interventional therapy will reduce the risk of death or debilitating stroke (due to hemorrhage or infarction) by an absolute magnitude of about 15% (over 10 years) for unruptured AVMs (from 30% to 15%); and, b) to test if endovascular treatment can improve the safety and efficacy of surgery or radiation therapy by at least 10% (80% to 90%).

As for the nested trial on the role of embolization in the treatment of Brain AVMs by other means: the pre-surgical or pre-radiosurgery embolization of cerebral AVMs can decrease the number of treatment failures from 20% to 10%. In addition,embolization of cerebral AVMs can be accomplished with an acceptable risk, defined as permanent disabling neurological complications of 8%.

ReferenceCitation: Fleetwood IG, Steinberg GK. Arteriovenous malformations. Lancet. 2002 Mar 9;359(9309):863-73. Review.

ReferenceCitation: Wedderburn CJ, van Beijnum J, Bhattacharya JJ, Counsell CE, Papanastassiou V, Ritchie V, Roberts RC, Sellar RJ, Warlow CP, Al-Shahi Salman R; SIVMS Collaborators. Outcome after interventional or conservative management of unruptured brain arteriovenous malformations: a prospective, population-based cohort study. Lancet Neurol. 2008 Mar;7(3):223-30. doi: 10.1016/S1474-4422(08)70026-7. Epub 2008 Feb 1.

ReferenceCitation: Brown RD Jr, Wiebers DO, Torner JC, O'Fallon WM. Frequency of intracranial hemorrhage as a presenting symptom and subtype analysis: a population-based study of intracranial vascular malformations in Olmsted Country, Minnesota. J Neurosurg. 1996 Jul;85(1):29-32.

ReferenceCitation: Brown RD Jr, Wiebers DO, Forbes G, O'Fallon WM, Piepgras DG, Marsh WR, Maciunas RJ. The natural history of unruptured intracranial arteriovenous malformations. J Neurosurg. 1988 Mar;68(3):352-7.

ReferenceCitation: Wilkins RH. Natural history of intracranial vascular malformations: a review. Neurosurgery. 1985 Mar;16(3):421-30. Review.

ReferenceCitation: da Costa L, Wallace MC, Ter Brugge KG, O'Kelly C, Willinsky RA, Tymianski M. The natural history and predictive features of hemorrhage from brain arteriovenous malformations. Stroke. 2009 Jan;40(1):100-5. doi: 10.1161/STROKEAHA.108.524678. Epub 2008 Nov 13.

ReferenceCitation: Gross BA, Du R. Natural history of cerebral arteriovenous malformations: a meta-analysis. J Neurosurg. 2013 Feb;118(2):437-43. doi: 10.3171/2012.10.JNS121280. Epub 2012 Nov 30. Review.

ReferenceCitation: Hernesniemi JA, Dashti R, Juvela S, Väärt K, Niemelä M, Laakso A. Natural history of brain arteriovenous malformations: a long-term follow-up study of risk of hemorrhage in 238 patients. Neurosurgery. 2008 Nov;63(5):823-9; discussion 829-31. doi: 10.1227/01.NEU.0000330401.82582.5E.

ReferenceCitation: Hartmann A, Mast H, Mohr JP, Koennecke HC, Osipov A, Pile-Spellman J, Duong DH, Young WL. Morbidity of intracranial hemorrhage in patients with cerebral arteriovenous malformation. Stroke. 1998 May;29(5):931-4.

ReferenceCitation: Hartmann A, Mast H, Mohr JP, Pile-Spellman J, Connolly ES, Sciacca RR, Khaw A, Stapf C. Determinants of staged endovascular and surgical treatment outcome of brain arteriovenous malformations. Stroke. 2005 Nov;36(11):2431-5. Epub 2005 Oct 13.

ReferenceCitation: Hartmann A, Stapf C, Hofmeister C, Mohr JP, Sciacca RR, Stein BM, Faulstich A, Mast H. Determinants of neurological outcome after surgery for brain arteriovenous malformation. Stroke. 2000 Oct;31(10):2361-4.

ReferenceCitation: Cockroft KM, Chang KE, Lehman EB, Harbaugh RE. AVM Management Equipoise Survey: physician opinions regarding the management of brain arteriovenous malformations. J Neurointerv Surg. 2014 Dec;6(10):748-53. doi: 10.1136/neurintsurg-2013-011030. Epub 2013 Dec 6.

ReferenceCitation: Cockroft KM. Unruptured brain arteriovenous malformations should be treated conservatively: no. Stroke. 2007 Dec;38(12):3310-1. Epub 2007 Oct 25.

ReferenceCitation: Stapf C, Mohr JP. Unruptured brain arteriovenous malformations should be treated conservatively: yes. Stroke. 2007 Dec;38(12):3308-9. Epub 2007 Oct 25.

ReferenceCitation: van Beijnum J, van der Worp HB, Buis DR, Al-Shahi Salman R, Kappelle LJ, Rinkel GJ, van der Sprenkel JW, Vandertop WP, Algra A, Klijn CJ. Treatment of brain arteriovenous malformations: a systematic review and meta-analysis. JAMA. 2011 Nov 9;306(18):2011-9. doi: 10.1001/jama.2011.1632. Review.

ReferenceCitation: Davies JM, Yanamadala V, Lawton MT. Comparative effectiveness of treatments for cerebral arteriovenous malformations: trends in nationwide outcomes from 2000 to 2009. Neurosurg Focus. 2012 Jul;33(1):E11. doi: 10.3171/2012.5.FOCUS12107.

ReferenceCitation: Morgan MK, Davidson AS, Koustais S, Simons M, Ritson EA. The failure of preoperative ethylene-vinyl alcohol copolymer embolization to improve outcomes in arteriovenous malformation management: case series. J Neurosurg. 2013 May;118(5):969-77. doi: 10.3171/2012.11.JNS112064. Epub 2013 Jan 25.

ReferenceCitation: Pierot L, Fiehler J, Cognard C, Söderman M, Spelle L. Will a randomized trial of unruptured brain arteriovenous malformations change our clinical practice? AJNR Am J Neuroradiol. 2014 Mar;35(3):416-7. doi: 10.3174/ajnr.A3867. Epub 2014 Jan 16.

ReferenceCitation: Raymond J; TEAM collaborative group. Reflections on the TEAM trial: why clinical care and research should be reconciled. Can J Neurol Sci. 2011 Mar;38(2):198-202.

ReferenceCitation: Saatci I, Geyik S, Yavuz K, Cekirge HS. Endovascular treatment of brain arteriovenous malformations with prolonged intranidal Onyx injection technique: long-term results in 350 consecutive patients with completed endovascular treatment course. J Neurosurg. 2011 Jul;115(1):78-88. doi: 10.3171/2011.2.JNS09830. Epub 2011 Apr 8.

ReferenceCitation: Spetzler RF, Martin NA. A proposed grading system for arteriovenous malformations. J Neurosurg. 1986 Oct;65(4):476-83.

ReferenceCitation: Darsaut TE, Magro E, Bojanowski MW, Chaalala C, Nico L, Bacchus E, Klink R, Iancu D, Weill A, Roy D, Sabatier JF, Cognard C, Januel AC, Pelissou-Guyotat I, Eker O, Roche PH, Graillon T, Brunel H, Proust F, Beaujeux R, Aldea S, Piotin M, Cornu P, Shotar E, Gaberel T, Barbier C, Corre ML, Costalat V, Jecko V, Barreau X, Morandi X, Gauvrit JY, Derrey S, Papagiannaki C, Nguyen TN, Abdalkader M, Tawk RG, Huynh T, Viard G, Gevry G, Gentric JC, Raymond J; TOBAS Collaborative Group; List of participating TOBAS centers and physicians . Surgical treatment of brain arteriovenous malformations: clinical outcomes of patients included in the registry of a pragmatic randomized trial. J Neurosurg. 2022 Sep 9:1-9. doi: 10.3171/2022.7.JNS22813. [Epub ahead of print]

ReferenceCitation: Magro E, Gentric JC, Batista AL, Kotowski M, Chaalala C, Roberge D, Weill A, Stapf C, Roy D, Bojanowski MW, Darsaut TE, Klink R, Raymond J. The Treatment of Brain AVMs Study (TOBAS): an all-inclusive framework to integrate clinical care and research. J Neurosurg. 2018 Jun;128(6):1823-1829. doi: 10.3171/2017.2.JNS162751. Epub 2017 Sep 1.

ReferenceCitation: Magro E, Gentric JC, Darsaut TE, Batista AL, Chaalala C, Roberge D, Weill A, Roy D, Bojanowski MW, Raymond J. [Treatment of brain AVMS (TOBAS): A randomized controlled trial and registry]. Neurochirurgie. 2016 Aug;62(4):197-202. doi: 10.1016/j.neuchi.2015.12.008. Epub 2016 May 25. French.

ReferenceCitation: Darsaut TE, Magro E, Gentric JC, Batista AL, Chaalala C, Roberge D, Bojanowski MW, Weill A, Roy D, Raymond J. Treatment of Brain AVMs (TOBAS): study protocol for a pragmatic randomized controlled trial. Trials. 2015 Nov 4;16:497. doi: 10.1186/s13063-015-1019-0.

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

location_country:
Brazil
Canada
United States
Chile
France

location_facility: Assistance Publique - Hôpitaux de Marseille

location_facility: CHRU de Brest (Brest University Hospital)

location_facility: Centre Hospit Régional Universitaire de Besançon

location_facility: Centre Hospitalier Universitaire de Lyon

location_facility: Centre Hospitalier Universitaire Hôpitaux de Rouen

location_facility: Centre Hospitalier Régional Universitaire de Tours

location_facility: Centre Hospitalier Régional Universitaire de Nancy

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: University of New Mexico Health Sciences Center

location_facility: Les Hôpitaux Universitaires de Strasbourg

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: Centre Hospitalier de l'Université de Montréal

location_facility: Centre Hospitalier Universitaire de Rennes

intervention_type: Radiation

lead_sponsor_type: academique


title: 2017-01: Blood Sample Collection to Evaluate Biomarkers for Hepatocellular Carcinoma

summary: The primary objective of this study is to obtain de-identified, clinically-characterized whole blood specimens for use in developing and evaluating the performance of new biomarker assays for detection of hepatocellular carcinoma (HCC).

time_perspective: Prospective

ReferenceCitation: Chalasani NP, Porter K, Bhattacharya A, Book AJ, Neis BM, Xiong KM, Ramasubramanian TS, Edwards DK 5th, Chen I, Johnson S, Roberts LR, Kisiel JB, Reddy KR, Singal AG, Olson MC, Bruinsma JJ. Validation of a Novel Multitarget Blood Test Shows High Sensitivity to Detect Early Stage Hepatocellular Carcinoma. Clin Gastroenterol Hepatol. 2022 Jan;20(1):173-182.e7. doi: 10.1016/j.cgh.2021.08.010. Epub 2021 Aug 13.

ReferenceCitation: Chalasani NP, Ramasubramanian TS, Bhattacharya A, Olson MC, Edwards V DK, Roberts LR, Kisiel JB, Reddy KR, Lidgard GP, Johnson SC, Bruinsma JJ. A Novel Blood-Based Panel of Methylated DNA and Protein Markers for Detection of Early-Stage Hepatocellular Carcinoma. Clin Gastroenterol Hepatol. 2021 Dec;19(12):2597-2605.e4. doi: 10.1016/j.cgh.2020.08.065. Epub 2020 Sep 2.

ipd_sharing_description: Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include text, tables, figures, and appendices. The study protocol, statistical analysis plan, informed consent form, and clinical study report will also be shared.

lead_sponsor: Exact Sciences Corporation

location_country:
Taiwan
Spain
Italy
Thailand
United States
France
Germany

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Hospital of the University of Pennsylvania

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Bon Secours Liver Institute of Hampton Roads

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Methodist Healthcare University Hospital

location_facility: Universidad Autonoma de Madrid - Hospital Universitario La Paz


title: Evaluation of an Immunomodulatory Maintenance Treatment in Patients With Metastatic Colorectal Cancer With Tumor Reduction During Induction Treatment

acronym: IMPALA

summary: The purpose of this this trial is to prove the efficacy and safety of MGN1703 as a maintenance therapy after first-line chemotherapeutic treatment of metastatic colorectal cancer.

status: Unknown status

lead_sponsor: Mologen AG

location_country:
Spain
Italy
Austria
Estonia
United Kingdom
France
Belgium
Germany

location_facility: Ospedale Civile SS Annunziata, U.O.C. Oncologia Medica

location_facility: Oxford University Hospitals NHS Trust - Churchill Hospital

location_facility: Hôpital Européen Georges Pompidou (HEGP)

location_facility: The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust - Royal Bournemouth Hospital

location_facility: York Teaching Hospitals NHS Fondation Trust, Research and Development department

location_facility: HELIOS Klinikum Wuppertal Medizinische Klinik I

location_facility: Klinikum Mittelbaden Medizinische Klinik II

location_facility: Hospital General Universitario Gregorio Marañón

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

location_facility: Medizinisches Versorgungszentrum Osthessen GmbH

location_facility: Medizinisches Versorgungszentrum Ärzteforum Seestrasse

location_facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia

location_facility: Ospedale Infermi di Rimini, U.O. Oncologia

location_facility: Universitätsklinikum Gießen und Marburg, Standort Gießen

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Onkologie Dreiländereck - Onkologische Schwerpunktpraxis Lörrach

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: DIAKO Ev. Diakonie-Krankenhaus gemeinnützige GmbH

location_facility: Hospital Universitario Arnau de Vilanova

location_facility: Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Clinique Saint Anne, Strasbourg Oncologie Liberale

location_facility: Hospital Universitario Central de Asturias

location_facility: St. Josef-Hospital im Katholischen Klinikum Bochum

location_facility: Complexo Hospitalario Universitario A Coruña


title: A Phase 2 Study of INCMGA00012 in Participants With Squamous Carcinoma of the Anal Canal Who Have Progressed Following Platinum-Based Chemotherapy (POD1UM-202)

summary: The purpose of this study is to assess the efficacy of INCMGA00012 in participants with locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) who have progressed after platinum-based chemotherapy.

ReferenceCitation: Rao S, Anandappa G, Capdevila J, Dahan L, Evesque L, Kim S, Saunders MP, Gilbert DC, Jensen LH, Samalin E, Spindler KL, Tamberi S, Demols A, Guren MG, Arnold D, Fakih M, Kayyal T, Cornfeld M, Tian C, Catlett M, Smith M, Spano JP. A phase II study of retifanlimab (INCMGA00012) in patients with squamous carcinoma of the anal canal who have progressed following platinum-based chemotherapy (POD1UM-202). ESMO Open. 2022 Aug;7(4):100529. doi: 10.1016/j.esmoop.2022.100529. Epub 2022 Jul 8.

lead_sponsor: Incyte Corporation

location_country:
Denmark
Spain
Italy
United Kingdom
United States
France
Belgium
Norway
Germany

location_facility: A.O.U. Policlinico V. Emanuele G. Rodolico

location_facility: Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau

location_facility: Irccs Azienda Ospedaliera Universitaria San Martino

location_facility: Centre Hospitalier Universitaire de Besancon

location_facility: Hospital General Universitari Vall D Hebron

location_facility: Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

location_facility: University Medical Centre Hamburg-Eppendorf, Centre of Oncology

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti

location_facility: Texas Oncology-Baylor Charles A. Sammons

location_facility: The Royal Marsden Nhs Foundation Trust - Chelsea


acronym: Measure Up 1

title: A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis

lead_sponsor: AbbVie

ReferenceCitation: Mendes-Bastos P, Ladizinski B, Guttman-Yassky E, Jiang P, Liu J, Prajapati VH, Simpson EL, Vigna N, Teixeira HD, Barbarot S. Characterization of acne associated with upadacitinib treatment in patients with moderate-to-severe atopic dermatitis: A post hoc integrated analysis of 3 phase 3 randomized, double-blind, placebo-controlled trials. J Am Acad Dermatol. 2022 Oct;87(4):784-791. doi: 10.1016/j.jaad.2022.06.012. Epub 2022 Jun 15.

ReferenceCitation: Simpson EL, Papp KA, Blauvelt A, Chu CY, Hong HC, Katoh N, Calimlim BM, Thyssen JP, Chiou AS, Bissonnette R, Stein Gold LF, Wegzyn C, Hu X, Liu M, Liu J, Tenorio AR, Chu AD, Guttman-Yassky E. Efficacy and Safety of Upadacitinib in Patients With Moderate to Severe Atopic Dermatitis: Analysis of Follow-up Data From the Measure Up 1 and Measure Up 2 Randomized Clinical Trials. JAMA Dermatol. 2022 Apr 1;158(4):404-413. doi: 10.1001/jamadermatol.2022.0029.

ReferenceCitation: Guttman-Yassky E, Teixeira HD, Simpson EL, Papp KA, Pangan AL, Blauvelt A, Thaçi D, Chu CY, Hong HC, Katoh N, Paller AS, Calimlim B, Gu Y, Hu X, Liu M, Yang Y, Liu J, Tenorio AR, Chu AD, Irvine AD. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised controlled phase 3 trials. Lancet. 2021 Jun 5;397(10290):2151-2168. doi: 10.1016/S0140-6736(21)00588-2. Epub 2021 May 21. Erratum in: Lancet. 2021 Jun 5;397(10290):2150.

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

location_country:
Croatia
United Kingdom
Italy
Ukraine
United States
Romania
Japan
Russian Federation
Australia
Argentina
Puerto Rico
Turkey
Malaysia
Bosnia and Herzegovina
Canada
Switzerland
China
Germany
Bulgaria
Denmark
Estonia
New Zealand
Finland
France
Colombia

location_facility: University Hospital Kyoto Prefectural University of Medicine /ID# 201876

location_facility: North Eastern Health Specialists /ID# 205802

location_facility: Erciyes University Medical Fac /ID# 204098

location_facility: A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 200741

location_facility: Dr. David Gratton Dermat Inc. /ID# 200309

location_facility: Psoriahue Med Interdisciplinar /ID# 202451

location_facility: Hospital Raja Permaisuri Bainun /ID# 204375

location_facility: Gazi Universitesi Tip Fakultes /ID# 204176

location_facility: California Allergy and Asthma Medical Group /ID# 200727

location_facility: Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 208598

location_facility: Chelyabinsk Regional Clinical Dermatovenerologic Dispensary /ID# 201996

location_facility: Clinical Center University of Sarajevo /ID# 202668

location_facility: Northwestern University Feinberg School of Medicine /ID# 201644

location_facility: Duplicate_Klinicki bolnicki centar Osijek /ID# 201523

location_facility: Instituto de Neumonología y Dermatología /ID# 203444

location_facility: Universitaetsklinikum Frankfurt /ID# 202089

location_facility: CMS3 Company for Medical Study /ID# 205193

location_facility: Ponce Medical School Foundation /ID# 201821

location_facility: Hopital Saint Vincent de Paul /ID# 218253

location_facility: Cabinet Medical de Dermatovenerologie Dr. Remus Orasan /ID# 205862

location_facility: UMHAT Dr Georgi Stranski EAD /ID# 201521

location_facility: Leavitt Medical Associates of Florida /ID# 200880

location_facility: Alliance Dermatology and MOHs /ID# 200375

location_facility: Peking University Third Hospital /ID# 202612

location_facility: Holdsworth House Medical Practice /ID# 211236

location_facility: University of Yamanashi Hospital /ID# 204174

location_facility: Hacettepe University Faculty of Medicine /ID# 204099

location_facility: Herlev and Gentofte Hospital /ID# 200736

location_facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 208597

location_facility: Care Access Research - Walnut Creek /ID# 200940

location_facility: Ural Research Institute of dermatovenerology and immunopathology /ID# 201593

location_facility: Northern Care Alliance NHS Group /ID# 201194

location_facility: Integrated Dermatology of Massachusetts, LLC /ID# 209468

location_facility: Saratov State Medical University n.a. V.I. Razumovskiy /ID# 201595

location_facility: Coastal Clinical Research Center of the Carolinas /ID# 200402

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 205192

location_facility: Forest Hills Dermatology Group /ID# 209244

location_facility: Confido Private Medical Clinic /ID# 200846

location_facility: North Estonia Medical Centre /ID# 200951

location_facility: Dermdox Dermatology Centers, PC /ID# 213782

location_facility: Dr. Wei Jing Loo Medicine Prof /ID# 206051

location_facility: Medizinische Hochschule Hannover /ID# 202091

location_facility: Clinical Dermatovenerology Dispensary /ID# 203439

location_facility: Military Hospital of Military-Medical Clinical Center of Southern Region /ID# 201962

location_facility: Klinika za dječje bolesti Zagreb /ID# 203151

location_facility: Dermatology Specialists of Spokane /ID# 202068

location_facility: Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara /ID# 200695

location_facility: Ctr Int de Reum del Caribe SAS /ID# 201620

location_facility: Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 204100

location_facility: Medical Cooperation Kojinkai Sapporo Skin Clinic /ID# 201239

location_facility: Advanced Dermatology of the Midlands /ID# 201689

location_facility: Dermatology Ottawa Research Centre /ID# 200319

location_facility: Duplicate_George Washington Univ Med /ID# 200364

location_facility: Bakersfield Derma & Skin Cance /ID# 200433

location_facility: Clear Dermatology & Aesthetics Center /ID# 201256

location_facility: Klinicki bolnicki centar Zagreb /ID# 201879

location_facility: Oregon Medical Res Center PC /ID# 200428

location_facility: Aichi Medical University Hospital /ID# 202833

location_facility: Allergy & Asthma Associates of Southern California /ID# 200733

location_facility: Clinical Trials Management, LLC - Covington /ID# 212658

location_facility: Integrated Clinical Research LLC /ID# 200900

location_facility: Clin Res Inst of Michigan, LLC /ID# 208019

location_facility: National Medical Research Center for Children's Health /ID# 203440

location_facility: Florida International Rsrch cr /ID# 218507

location_facility: Inselspital, Universitätsspital Bern /ID# 201598

location_facility: Guy's and St Thomas' NHS Foundation Trust /ID# 201192

location_facility: Modern Research Associates, PL /ID# 200705

location_facility: Klinicki bolnicki centar Split /ID# 201527

location_facility: University Clinical Centre of the Republic of Srpska /ID# 202667

location_facility: Clinical Center University of Sarajevo /ID# 202669

location_facility: Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers /ID# 202891

location_facility: Lynn Health Science Institute (LHSI) /ID# 212676

location_facility: The second Affiliated hospital of Zhejiang University school of Medicine /ID# 202608

location_facility: Icahn School of Medicine at Mount Sinai /ID# 200370

location_facility: Fundacion Centro de Excelencia en Enfermedades Cronicas no Transmisibles - FUNCE /ID# 201905

location_facility: Dermatology Research Institute Inc. /ID# 200318

location_facility: Clinical Research Consortium /ID# 200734

location_facility: CHUV, Centre hospitalier universitaire vaudois /ID# 206505

location_facility: CHUV, Centre hospitalier universitaire vaudois /ID# 200910

location_facility: The South Bend Clinic Center /ID# 200371

location_facility: University Clinical Centre of the Republic of Srpska /ID# 202666

location_facility: Chelsea and Westminster Hospital NHS Foundation Trust9 /ID# 201971

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 202255

location_facility: Massachusetts General Hospital /ID# 200474

location_facility: Hamilton Health Sciences - McMaster University Medical Centre /ID# 200313

location_facility: Universitaetsklinikum Muenster /ID# 202085

location_facility: Clinical Research Puerto Rico /ID# 203309

location_facility: CHU Toulouse - Hopital Larrey /ID# 201528

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 202554

location_facility: Hôpitaux Universitaires Genève /ID# 201600

location_facility: San Luis Derm and Laser Clinic /ID# 200372

location_facility: ME "Rivne Regional Dermatology and Venereology Dispensary" of RRC /ID# 210504

location_facility: Fondazione PTV Policlinico Tor Vergata /ID# 201136

location_facility: Multi-Speciality Research Associates /ID# 213254

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 206377

location_facility: The First Hospital of China Medical University /ID# 202615

location_facility: Dermatology Physicians of Connecticut /ID# 200928

location_facility: A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 200746

location_facility: Dre Angelique Gagne-Henley M.D. inc. /ID# 200326

location_facility: Dr. Chih-ho Hong Medical Inc. /ID# 200311

location_facility: Oregon Health and Science University /ID# 200992

location_facility: Peking University People's Hospital /ID# 202549

location_facility: Klinicki bolnicki centar Rijeka /ID# 217423

location_facility: Azienda Ospedaliera Universitaria Federico II /ID# 200750

location_facility: Fundacion Hospital San Vicente de Paul - Rionegro /ID# 202043

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 200692

location_facility: West Middlesex University Hospital /ID# 202273

location_facility: The Third Affiliated Hospital Of Sun Yat-Sen University /ID# 202548

location_facility: Center for Clinical Studies - Webster TX /ID# 203185

location_facility: Arlington Research Center, Inc /ID# 200391

location_facility: Clinical Trials Management, LLC - Metairie /ID# 212659

location_facility: Bispebjerg and Frederiksberg Hospital /ID# 200979

location_facility: UMHAT Professor Stoyan Kirkovich /ID# 201522

location_facility: Huashan Hospital of Fudan University /ID# 205760

location_facility: Duplicate_Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 202087

location_facility: Wiseman Dermatology Research /ID# 200323

summary: The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.