acronym: eMonarcHER

title: eMonarcHER: A Randomized, Double Blind, Placebo-Controlled Phase 3 Study of Abemaciclib Plus Standard Adjuvant Endocrine Therapy in Participants With High-Risk, Node-Positive, HR+, HER2+ Early Breast Cancer Who Have Completed Adjuvant HER2-Targeted Therapy

lead_sponsor: Eli Lilly and Company

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Austria
Australia
Argentina
Puerto Rico
Israel
Mexico
Sweden
Brazil
Switzerland
Hungary
China
Germany
Taiwan
Greece
Finland
Korea, Republic of
France

location_facility: IBCC - Instituto Brasileiro de Controle do Câncer

location_facility: The First Afflilated Hospital of Bengbu Medical College

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

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

location_facility: Koo Foundation Sun Yan-Sen Cancer Center

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Walter Reed National Military Medical Center

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

location_facility: Policlinico Gemelli - Università Cattolica del Sacro Cuore

location_facility: Klinikum Mannheim gGmbH Universitätsmedizin

location_facility: ÜBAG-Med. Versorgungszentrum - VK&K Studien GbR

location_facility: Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer

location_facility: Instituto de Pesquisa Notredame Intermedica

location_facility: Euromedica - General Clinic of Thessaloniki

location_facility: California Cancer Associates in Research and Excellence

location_facility: South Broward Hospital District - Memorial Healthcare System

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

location_facility: Inova Dwight and Martha Schar Center Institute

location_facility: COI Centro Oncológico Intl. S.A.P.I. de C.V._ S.F.

location_facility: Dwight D. Eisenhower Army Medical Center, Hem/Onc Svc

location_facility: Instituto de Investigaciones Clínicas Mar del Plata

location_facility: Instituto de Ensino e Pesquisas São Lucas - IEP Hemomed

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: St. Vincenz-Krankenhaus Frauen- und Kinderklinik

location_facility: Complexo Hospitalario Universitario A Coruña, CHUAC

location_facility: Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Instituto de Educação, Pesquisa e Gestão em Saúde

location_facility: General Oncology Hospital of Kifissia "Agioi Anargiroi"

location_facility: Banner MD Anderson Cancer Center at North Colorado Medical Center

location_facility: University of Texas Health Science Center - San Antonio

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: New England Cancer Specialists - Scarborough

location_facility: Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan

location_facility: West China Hospital of Sichuan University

location_facility: TRIO-US (Translational Research in Oncology-US)

location_facility: Fundación CORI para la Investigación y Prevención del Cáncer

location_facility: Seoul National University Bundang Hospital

location_facility: Karolinska Universitetssjukhuset i Solna

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Xinjiang Medical University Cancer Hospital

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Xiangya Hospital Central South University

location_facility: Institut de Cancérologie de Lorraine Alexis Vautrin

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Baylor Scott & White Medical Center - Temple

location_facility: Cancer Trtmt Ctrs of Am, SE Reg Med Ctr., Inc.

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

summary: The main purpose of this study is to measure how well abemaciclib works in participants with early breast cancer who are taking hormone therapy after surgery. Participants must have breast cancer that is hormone receptor positive (HR+) and human epidermal receptor 2 positive (HER2+). Your participation could last up to 10 years depending on how you and your tumor respond.


title: A 52-week, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Study of the Efficacy and Safety of GSK3511294 Adjunctive Therapy in Adult and Adolescent Participants With Severe Uncontrolled Asthma With an Eosinophilic Phenotype

summary: This is a multi-center, randomized, placebo-controlled, double-blind, parallel group study that aims to assess the efficacy and safety of GSK3511294 (Depemokimab) in participants with severe uncontrolled asthma with an eosinophilic phenotype

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline

location_country:
Poland
Spain
Ireland
Italy
Russian Federation
United Kingdom
Canada
United States
France
China
Germany
Czechia

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Ongoing


type: EudraCT Number

type: Other Identifier

title: Single-arm, Phase 2 Study of Valemetostat Tosylate Monotherapy in Subjects With Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)

summary: This study will characterize the safety and clinical benefit of valemetostat tosylate in participants with relapsed/refractory peripheral T-cell lymphoma, including relapsed/refractory adult T-cell leukemia/lymphoma.

status: Active, not recruiting

design_allocation: Non-Randomized

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

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

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

location_facility: Fondazione Pascale, IRCCS, Istituto Nazionale dei Tumori

location_facility: Washington University School of Medicine

location_facility: University Health Network Princess Margaret Hospital

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Universitätsklinikum Halle (Saale) - Klinik und Poliklinik für Innere Medizin IV

location_facility: Leids Universitair Medisch Centrum (LUMC) (Leiden University Medical Center)

location_facility: Centre Hospitalier Lyon Sud - Hématologie

location_facility: ASST Papa Giovanni XXIII - Medicina Trasfusionale ed Ematologia - Bergamo

location_facility: Universiteit Maastricht Academisch Ziekenhuis Maastricht

location_facility: National Cheng Kung University Hospital - Internal Medicine

location_facility: Stanford University Medical Center - Cancer Clinical Trials Office - ONCOLOGY

location_facility: Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-Oncopole)

location_facility: Hokkaido University Hospital - Medical Oncology Center

location_facility: University of Pennsylvania Perelman Center for Advanced Medicine

location_facility: University Hospital - Kyoto Prefectural University of Medicine

location_facility: Seoul National University Hospital - Department of Internal

location_facility: National Taiwan University Hospital - Hematology And Oncology

location_facility: Memorial Sloan-Kettering Cancer Center at Memorial Hospital

location_facility: Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology

location_facility: Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Hematology and Oncology - Hematology and Oncology

location_facility: Northwestern University - Feinberg School of Medicine

location_facility: Nottingham City Hospital - Clinical Haematology

location_facility: CHRU de Lille - Hôpital Claude Huriez - Maladies du Sang

location_facility: Hackensack University Medical Center - John Theurer Cancer Center

location_facility: Samsung Medical Center - Hematology-Oncology

location_facility: Emory University Hospital - Winship Cancer Institute

location_facility: National Hospital Organization Nagoya Medical Center - Hematology

location_facility: Ospedale S.Maria della Misericordia, AO di Perugia, Università degli Studi di Perugia

location_facility: Hospital Universitario Fundación Jiménez Díaz

intervention_type: Drug


title: A Randomized, Open-Label, Phase 3 Trial of Tisotumab Vedotin vs Investigator's Choice Chemotherapy in Second- or Third-Line Recurrent or Metastatic Cervical Cancer

acronym: innovaTV 301

summary:
This trial is being done to find out whether tisotumab vedotin works better than chemotherapy to treat cervical cancer. People in this study have cervical cancer that has spread to other parts of the body (metastatic) or has come back after being treated (recurrent).

Participants in this trial will be randomly assigned to one of two groups. One group will be treated with tisotumab vedotin. Participants in the other group will get one of five different chemotherapy drugs (topotecan, vinorelbine, gemcitabine, pemetrexed, or irinotecan). Participants and their doctors will know which group they are in. Participants in the chemotherapy group will decide with their study doctor which drug they will take.

lead_sponsor: Seagen Inc.

location_country:
Spain
Italy
United Kingdom
United States
Peru
Belgium
Japan
Czechia
Austria
Argentina
Mexico
Norway
Singapore
Sweden
Brazil
Canada
Hungary
Germany
Denmark
Taiwan
Finland
Korea, Republic of
France
Netherlands

location_facility: Medical and Health Science Centre Debrecen Institution of Internal Medicine

location_facility: University of California Irvine Medical Center

location_facility: Soon Chun Hyang University Hospital Seoul

location_facility: Trondheim University Hospital, Trondheim

location_facility: British Columbia Cancer Agency - Vancouver Centre

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Centro de Pesquisaem Oncologia - HSL-PUCRS

location_facility: Fakultni Nemocnice Olomouc (Fnol) - Onkologicka Klinika

location_facility: Sungkyunkwan University of Medicine - Samsung Changwon Hospital

location_facility: Willis-Knighton Physician Network/Gynecologic Oncology Associates

location_facility: Fondazione Policlinico Universitario Agostino

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: University Health Network, Princess Margaret Hospital

location_facility: Institut de cancerologie Strasbourg Europe

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: National University Cancer Institute, Singapore

location_facility: National Hospital Organization Kure Medical Center and Chugoku Cancer Center

location_facility: Fundação Natonio Prudente (AC Camargo Cancer Center)

location_facility: Instituto Brasileiro de Controle do Cancer

location_facility: Institute Cancer De Lorraine (ICL) - Alexis Vautrin

location_facility: Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz

location_facility: UNC Lineberger Comprehensive Cancer Center / University of North Carolina

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Uppsala University Hospital (Akademiska Sjukhuset)

location_facility: Royal Devon and Exeter NHS Foundation Trust

location_facility: IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.l

location_facility: Nippon Medical School Musashi Kosugi Hospital

location_facility: Oslo University Hospital, Radiumhospitalet

location_facility: Gynecological Cancer Institute of Chicago, LLC

location_facility: Seoul National University Bundang Hospital

location_facility: Keimyung University Dongsan Medical Center

location_facility: Virginia Commonwealth University Medical Center

location_facility: CARIO - Centre Armoricain De Radiothérapie, D'imagerie Médicale Et D'oncologie

location_facility: New York University (NYU) Cancer Institute

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Skanes University Hospital - Universitetssjukhus

location_facility: Ohio State University Clinical Trials Management Office

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon - Site Avron (Hopital de la Croix Saint-Simon)

location_facility: Carbone Cancer Center / University of Wisconsin

location_facility: University of Alberta / Cross Cancer Institute


ipd_sharing: No

acronym: EPCORE™ NHL-2

title: A Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Combination With Other Agents in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)

lead_sponsor: Genmab

source: euctr

location_country:
Denmark
Spain
Italy
United Kingdom
Australia
Finland
Sweden
United States
France
Belgium
Norway
Netherlands
Czechia

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

location_facility: UMPC Hillman Cancer Center Cancer Pavillion

location_facility: Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia

location_facility: John Theurer Cancer Center at Hackensack UMC

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Oslo Universitetssykehus HF, Radiumhospitalet

location_facility: Fondazione del Piemonte per l Oncologia Istituto di Candiolo IRCCS

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Universitair Medisch Centrum Groningen (UMCG)

summary: A phase 1b/2, open-label, multinational, interventional trial to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics/biomarkers, immunogenicity, and preliminary efficacy of epcoritamab in combination with other standard of care (SOC) agents in subjects with B-cell Non-Hodgkin Lymphoma (B-NHL).


title: A Randomized, Open Label Phase 2/3 Study Comparing Cobolimab + Dostarlimab + Docetaxel To Dostarlimab + Docetaxel To Docetaxel Alone In Participants With Advanced Nonsmall Cell Lung Cancer Who Have Progressed On Prior Anti-PD-(L)1 Therapy And Chemotherapy (COSTAR Lung)

acronym: COSTAR Lung

summary: This is a multi-center, parallel group treatment, Phase 2/3 open label study evaluating cobolimab in combination with dostarlimab and docetaxel in participants with advanced Non-small cell Lung Cancer (NSCLC) who have progressed on prior anti-PD-(L)1 therapy and chemotherapy.

location_country:
Poland
Brazil
Romania
Spain
Italy
Russian Federation
Australia
Netherlands
Argentina
Canada
United Kingdom
Sweden
Korea, Republic of
United States
France
Mexico
Germany


title: A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adolescent Patients 12 to 17 Years of Age With Chronic Migraine - the REBUILD-2 Study

location_country:
Denmark
Spain
Italy
Netherlands
Puerto Rico
India
United States
France
Mexico
Japan
Germany

location_facility: CHRU de Lille - Service de neuropédiatrie

location_facility: P.D. Hinduja Hospital and Medical Research Centre

location_facility: Cincinnati Childrens Hospital Medical Center

location_facility: PanAmerican Clinical Research S.A.de C.V. Guadalajara

location_facility: 21st Century Neurology, a division of Xenoscience

location_facility: Houston Neurology Clinical & Diagnostic Consultants

location_facility: Hospital Infantil de Mexico Federico Gomez

location_facility: All India Institute of Medical Sciences - Nagpur

location_facility: University of Miami Don Suffer Clinical Research Building

location_facility: Children Mercy Pediatric Clinical Research Unit

location_facility: University of Texas Southwestern Medical Center at Dallas

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

location_facility: MemorialCare Health System - Long Beach Medical Center

location_facility: Clinica De Enfermedades Cronicas y Procedimientos Especiales

location_facility: Centre Hospitalier Universitaire Estaing

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Barrow Neurological Institute at Phoenix Children's Hospital

location_facility: University of Kentucky College of Medicine

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Orange County Research Institute - Ontario

location_facility: Centro de Investigacion Medica Aguascalientes

location_facility: Praxis Dr. med. Astrid Gendolla Praxis für Neurologie, Psychosomatik,Nervenheilkunde, Psychotherapieund Spezielle Schmerztherapie

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Northwell Health- Division of Pediatric Neurology

location_facility: Mangala Hospital & Mangala Kidney Foundation

location_facility: Central India Cardiology and Research Institute

location_facility: G.B. Pant Institute of Postgraduate Medical Education & Research

summary: The main purpose of this study is to evaluate the efficacy and safety of galcanezumab for the preventive treatment of chronic migraine in participants 12 to 17 years of age. The primary objective is to demonstrate the superiority of galcanezumab versus placebo in the reduction of monthly migraine headache days across the 3-month double-blind treatment period.


title: A Phase IIa Efficacy and Safety Trial With Intravenous S95011 in Primary Sjögren's Syndrome Patients: An International, Multicentre, Randomised, Double-blind, Placebo-controlled Study

summary: The purpose of this study is to assess the effect of multiple intravenous infusions of S95011 compared to placebo in reducing disease activity in patients with primary Sjögren's syndrome.

ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH).

The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

lead_sponsor: Institut de Recherches Internationales Servier

location_country:
Spain
United Kingdom
Australia
Canada
Hungary
United States
France
Germany

location_facility: Szent-Györgyi Albert Klinikai Központ, Remautológiai és Immunológiai Klinika

location_facility: Southampton General Hospital, University Hospital Southampton NHS Trust

location_facility: Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust

location_facility: Debreceni Egyetem Orvos és Egészségtudományi Centrum Belgyógyászat C épület - Klinikai Immunológiai Tanszék

location_facility: Universitätsklinikum Erlangen Medizinische Klinik 3 Rheumatologie und Immunologie

location_facility: CLINICA SAGRADA FAMILIA Servicio de Reumatología y Unidad de Ensayos Clínicos

location_facility: Hospital Infanta Luisa Quirón Salud Servicio de Reumatología

location_facility: The Queen Elizabeth Hospital Rheumatology Unit

location_facility: Vita Verum Medical Bt. Berényi u. 72-100. 95. számú épület 16. Rendelő

location_facility: CLINICAL GAIAS SANTIAGO Servicio de Reumatología

location_facility: Dél-Pesti Centrumkórház, Országos Hematológiai és Infektológiai Intézet, Infektológia

location_facility: Békés Megyei Központi Kórház, Pándy Kálmán Tagkórház, Infektológia-Hepatológia

location_facility: Universitätsklinikum Freiburg Department Innere Medizin Klinik für Rheumatologie und Klinische Immunologie

location_facility: Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust


title: A Phase III Multicenter Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Adult Patients With Relapsing Multiple Sclerosis

acronym: FENhance

summary: A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS. Eligible participants will be randomized 1:1 to either fenebrutinib or teriflunomide. Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.

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

lead_sponsor: Hoffmann-La Roche

location_country:
Denmark
Poland
Brazil
United Kingdom
Greece
Austria
Italy
Russian Federation
Canada
Guatemala
Korea, Republic of
United States
France
India
Puerto Rico
Mexico
Turkey
Bulgaria

location_facility: Hopital européen de Marseille; Neurologie

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos

location_facility: Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B

location_facility: Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.

location_facility: The Ottawa Hospital - General Campus; Department of Neurology - Multiple Sclerosis

location_facility: Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari; Neuroscienze e Organi di Senso

location_facility: Hospital Eginition; First Department of Neurology

location_facility: Wayne State University; Department of Neurology

location_facility: University General Hospital of Ioannina; Neurology Clinic

location_facility: Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis

location_facility: Hospital Santa Marcelina; AME - Ambulatório de Especialidades Médicas

location_facility: Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

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

location_facility: State Novosibirsk Regional Clinical Hospital

location_facility: Selcuk University Medical Faculty; Norology department

location_facility: Clinica Neurologica; Neurocirurgica de Joinville

location_facility: Karadeniz Tecnical Uni. Med. Fac.; Neurology

location_facility: Ospedale Binaghi; Centro Sclerosi Multipla

location_facility: Ospedale Civile di Montichiari; Centro Sclerosi Multipla

location_facility: Stanford University Medical Center; Stanford Neuroscience Health Center

location_facility: AOU Policlinico Giaccone; UOC Neurologia e Neurofisiopatologia-Amb Sclerosi Multipla

location_facility: UMHAT Dr. Georgi Stranski; 2nd Neurology Clinic, Occupational Diseases

location_facility: NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek

location_facility: A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche

location_facility: Mersin University Medical Faculty; Neurology

location_facility: Regional clinical hospital named after prof. S.V. Ochapovsky

location_facility: Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie

location_facility: Neuro Institute of New England P.C.; Research

location_facility: Unidad de investigacion en salud (UIS); Neurociencias

location_facility: Kepler Universitätskliniken GmbH - Med Campus III; Neurologie & Psychiatrie

location_facility: IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla

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

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

location_facility: Gazi University Medical Faculty; Departmant of Neurology.

location_facility: MUCH - Montreal Neurological Institute & Hospital

location_facility: Sydvestjysk Sygehus Esbjerg; Neurologisk Afd., Skleroseklinikken

location_facility: IBISMED Wielospecjalistyczne Centrum Medyczne

location_facility: IRCCS Istituto Neurologico C. Mondino-Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla

location_facility: Sancaktepe Training and Research Hospital; Neurology

location_facility: Santa Casa de Misericordia; de Belo Horizonte

location_facility: Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

location_facility: L2 Ip Instituto de Pesquisas Clinicas Ltda ME; Centro Medico Hospitalar

location_facility: University General Hospital of Larisa; Neurology Clinic

location_facility: Policlinico Universitario A. Gemelli; UOC Neurologia - Centro Sclerosi Multipla

location_facility: Hacettepe University Medical Faculty; Neurology

location_facility: Universita' G. D'Annunzio; Dipartimento di Neuroscienze, Imaging e Scienze Cliniche

location_facility: Malopolskie Centrum Diagnostyczne MEDICAL Sp. z o. o.

location_facility: Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari

location_facility: Federal center of brain research and neurotechnologies

location_facility: Ondokuz Mayis University School of Medicine; Neurology

location_facility: Los Angeles Biomedical Research Institute at Harbor-UCLA

location_facility: AHEPA Univ. General Hospital of Thessaloniki; B' Neurology Dept.

location_facility: CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital

location_facility: Keimyung University Dongsan Medical Center

location_facility: University of Cincinnati; Department of Neurology

location_facility: Hôpital Charles Nicolle; Service de Neurologie

location_facility: Unidad de Investigación en Salud; Psiquiatria

location_facility: Rigshospitalet; Neurologisk Klinik Glostrup

location_facility: Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali

location_facility: Regional Clinical Hospital N.A. Semashko; Neurology

location_facility: Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Badań Klinicznych

location_facility: Medizinische Universität Wien; Univ.Klinik fuer Neurologie

location_facility: Kocaeli University Hospital; Department of Neurology

location_facility: Van Yuzuncu Yil University Hospital; Neurology

location_facility: Deenanath Mangeshkar Hospital & Research Centre

location_facility: Aalborg Universitetshospital; Neurologisk Afdeling og Neurofysiologisk Afdeling; Skleroseamb.

location_facility: National Center of Social Significant Disease

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

location_facility: Hospital Universitario Clementino Fraga Filho - UFRJ

location_facility: Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico; UOSD Malattie Neurodegenerative

location_facility: Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik; Neurology

location_facility: Hjerne- og nervesygdomme, Ambulatorium, Skleroseklinikken

location_facility: CHU toulouse - Hôpital Purpan; Departement de Neurologie

location_facility: Ospedale S.Camillo Forlanini; UOSD Day Hospital Neurologico e Neurochirurgico


title: A Phase IIIb Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Peru
Belgium
Czechia
Poland
Portugal
Russian Federation
Australia
Argentina
Israel
Turkey
Mexico
Brazil
Canada
Switzerland
Hungary
Germany
Denmark
Greece
France
Netherlands

location_facility: MS and Neuromuscular Center of Excellence

location_facility: Studienzentrum für Neurologie und Psychiatrie

location_facility: Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften

location_facility: Washington University School of Medicine

location_facility: Universitätsklinikum Jena, Klinik für Neurologie

location_facility: Mountain Neurological Research Center; Roaring Fork Neurologt, P.C.

location_facility: Austin Hospital; Department of Neurology

location_facility: St. Josef-Hospital, Klinik für Neurologie

location_facility: PANAKEIA - Arzneimittelforschung Leipzig GmbH

location_facility: Fakultni nemocnice Motol; Neurologicka klinika

location_facility: Hospital de Santa Maria; Servico de Neurologia

location_facility: Barzilai Medical Center; Neurology Department

location_facility: Hospital Puerta del Mar; Sevicio de Neurologia

location_facility: Tel Aviv Sourasky Medical Center; Department of Neurology

location_facility: The Ottawa Hospital - General Campus; Department of Neurology - Multiple Sclerosis

location_facility: Fraser Health Authority - Fraser Health Multiple Sclerosis

location_facility: Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari; Neuroscienze e Organi di Senso

location_facility: Regional Clinical Hospital; Neurology Department

location_facility: Universität Leipzig; Innere Medizin, Neurologie, Dermatologie

location_facility: A.O. Universitaria S. Luigi Gonzaga Di Orbassano

location_facility: Municipal Institution Cherkasy Regional Hospital of Cherkasy Regional Council

location_facility: Inselspital Bern Medizin Neurologie; Neurologische Poliklinik

location_facility: Hospital Alvaro Cunqueiro; Servicio de Neurologia

location_facility: Foothills Medical Centre; Centre Dept of Medical Clinical Neuroscience

location_facility: Wayne State University; Department of Neurology

location_facility: Medizinische Hochschule Hannover, Klinik für Neurologie

location_facility: University General Hospital of Ioannina; Neurology Clinic

location_facility: Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

location_facility: Nemocnice Jihlava; NEU-Neurologicke oddeleni

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia

location_facility: Hospital Beatriz Angelo; Servico de Neurologia

location_facility: Rigshospitalet Glostrup; Neurologisk Klinik

location_facility: Universitätsklinikum Ulm; Klinik für Neurologie

location_facility: Zuyderland Medisch Centrum - Sittard Geleen

location_facility: National Hospital for Neurology and Neurosurgery,; MRC Centre for Neuromuscular Diseases

location_facility: Selcuk University Medical Faculty; Norology department

location_facility: Clinica Neurologica; Neurocirurgica de Joinville

location_facility: The NeuroMedical Clinic of Central Louisiana

location_facility: Gemeinschaftspraxis für Neurologie; Dr. Katrin Schulte, Dr. Nils Richter, Dr. Margarete Capito

location_facility: Karadeniz Tecnical Uni. Med. Fac.; Neurology

location_facility: Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C.

location_facility: Istanbul University Istanbul Medical Faculty; Neurology

location_facility: Mun.Med.Proph.Inst."Chernihiv Reg.Hosp."; Neurology Department

location_facility: Stanford University Medical Center; Stanford Neuroscience Health Center

location_facility: Universitätsklinikum Tübingen, Zentrum für Neurologie

location_facility: Wojskowy Instytut Medyczny Centralny Szpital Kliniczny MON

location_facility: Neurology Associates, PA; Research Department

location_facility: Saratov State Medical University of RosZdrav; Neurology

location_facility: Mersin University Medical Faculty; Neurology

location_facility: AOU Seconda Università degli Studi; Dip.Assistenziale Integrato Medicina Int-I Clinica Neurologica

location_facility: Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie

location_facility: Centre Hospitalier Affilie Universitaire de Quebec - Hopital de L'Enfant Jesus

location_facility: IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla

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

location_facility: Ospedale Regionale di Lugano - Civico; Neurologia

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

location_facility: Instituto Nacional de Ciencias Neurológicas - Hospital Mogrovejo; Peru

location_facility: Zaporizhia City Multispecialty Clinical Hospital #9

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

location_facility: Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion

location_facility: AOU Seconda Università degli Studi; Dip. Assistenziale Integrato Medicina Int-II Clinica Neurologica

location_facility: Hopital Cote De Nacre; Unite Neurologie Generale

location_facility: Sancaktepe Training and Research Hospital; Neurology

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz; Department of Neurology

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

location_facility: Krankenhaus Martha-Maria Hallo-Dölau, Klinik für Neurologie

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Neurologia

location_facility: Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

location_facility: University General Hospital of Larisa; Neurology Clinic

location_facility: Universitaetsklinikum Marburg; Klinik fuer Neurologie

location_facility: Policlinico Umberto I; Centro Sclerosi Multipla DAI Neuroscienze e Salute Mentale

location_facility: Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY

location_facility: Universita' G. D'Annunzio; Dipartimento di Neuroscienze, Imaging e Scienze Cliniche

location_facility: State institution of health care - Territorial Clinical Hospital

location_facility: Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari

location_facility: Federal center of brain research and neurotechnologies

location_facility: Fakultni nemocnice u sv. Anny; Neurologicka klinika

location_facility: Deutsche Klinik für Diagnostik; DKD Helios Klinik Wiesbaden, Abt. Neurologie

location_facility: Ondokuz Mayis University School of Medicine; Neurology

location_facility: Hospital Regional Universitario de Malaga - Hospital General; Servicio de Neurologia

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Cleveland Clinic Lou Ruvo; Center for Brain Research

location_facility: Medical Center of Private Execution First Private Clinic

location_facility: Fondazione IRCCS CA GRANDA Ospedale Maggiore Policlinico; Centro Dino Ferrari, Div. di Neurologia

location_facility: CHU de Besancon Hopital Jean Minjoz; Service de Neurologie

location_facility: City Clinical Hospital #24; Multipal Sclerosis department

location_facility: AHEPA Univ. General Hospital of Thessaloniki; B' Neurology Dept.

location_facility: KSMU Interregional Clinical Diagnostic Centre

location_facility: N.P. Bechtereva Institute of the Human Brain

location_facility: Nemocnice Teplice; Neurologicke Oddeleni - Ms Centrum

location_facility: Hospital Nacional Carlos Alberto Seguin Escobedo

location_facility: Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E)

location_facility: SHI Sverdlovsk Regional Clinical Hospital #1;Neurology

location_facility: Hôpital Charles Nicolle; Service de Neurologie

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

location_facility: CHU Hopital Gabriel Montpied; Service de Neurologie

location_facility: The Chaim Sheba Medical Center; Multiple Sclerosis Center

location_facility: CHU Brest Hopital La Cavale Blanche; Neurologie

location_facility: Centro Hospitalar de Lisboa Ocidental - Hospital Egas Moniz; Neurologia

location_facility: Clinica Internacional; Unidad De Investigacion

location_facility: City Hospital #40 of Kurortniy Administrative District

location_facility: St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU; Dept. of Neuroinfection and Multiply Sclerosis

location_facility: Krajska Nemocnice Pardubice Neurologicka Klinika

location_facility: NSHI "Central Clinical Hospital #2 of JSC "Russian Railways" n.a. N.A. Semashko"

location_facility: Universitätsspital Basel Medizin Neurologie; Neurologische Poliklinik

location_facility: Neurologische Gemeinschaftspraxis Kassel und Vellmar, Ch. Lassek, Dres. Ammerbach, Fetzer, M. Fische

location_facility: SPZOZ Uniwersytecki Szp. Klin. nr1 im.N.Barlickiego UM;Oddzial Kliniczny Neurologii

location_facility: University of California Davis Medical Center

location_facility: Krankenhaus der Barmherzigen Brüder Trier; Neurologie, Neurophysiol. neurolog.Reha/Schlaganfalleinh

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

location_facility: Hospital Quiron de Madrid; Servicio de Neurologia

location_facility: Kantonsspital Aarau AG Medizin Neurologie; Neurologie

location_facility: Universitätsklinikum Schleswig-Holstein; Klinik für Neurologie

location_facility: Charles University, Medical faculty, Hradec Kralove ;Department of Neurology

location_facility: Oklahoma Medical Research Foundation; MS Center of Excellence

location_facility: Gesundheitszentrum St. Johannes Hospital; Neurolog. Gemeinschaftspraxis Dres. Schmidt, Neudecker etc

location_facility: 401 Military Hospital of Athens; Neurology Department

location_facility: Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla

summary: This is a randomized, double blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and pharmacokinetics of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks in participants with RMS, in comparison to the approved 600 mg dose of ocrelizumab.


acronym: Ravulizumab in TMA after HSCT

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Ravulizumab in Adult and Adolescent Participants Who Have Thrombotic Microangiopathy (TMA) After Hematopoietic Stem Cell Transplant (HSCT)

lead_sponsor: Alexion Pharmaceuticals

location_country:
Poland
Spain
Greece
Italy
Australia
Netherlands
Canada
United Kingdom
Sweden
Korea, Republic of
United States
France
Israel
Belgium
Japan
Germany

location_facility:
Clinical Study Site
Clinical Trial Site
Clinical Trial Manager

summary: This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab in adult and adolescent participants with hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). In Stage 1, an open-label, single-arm period, the dosing regimen will be confirmed. In Stage 2, participants will be randomized to receive either blinded ravulizumab plus best supportive care or matching placebo plus best supportive care. The treatment period is 26 weeks (open-label for Stage 1, and randomized, double-blind, and placebo-controlled for Stage 2) followed by a 26-week follow-up period.


acronym: MESSINA

title: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo Controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis

lead_sponsor: AstraZeneca

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.

enrollment_type: Actual

location_country:
Poland
Spain
Italy
Russian Federation
Netherlands
United Kingdom
Canada
United States
Israel
France
Japan
Germany

summary: The aim of this Phase 3 study is to investigate the use of benralizumab as a treatment for patients with EoE. The effect of doses of benralizumab on EoE histologic signs and symptoms will be assessed over a 52-week treatment period (including a 24-week double-blind placebo-controlled treatment period and a 28-week open-label treatment period). It is proposed that benralizumab will deplete eosinophils from GI tissue(s), improve the symptoms of dysphagia, and improve endoscopy scores as well as other markers of disease activity. Upon completion of the initial 52-week treatment period, patients will be offered an additional Open Label Extension period of at least 1 year, with benralizumab treatment and ongoing study assessments.


title: A Registry to Collect the Natural History of Solid Tumour Cancers in Patients Profiled With a Next-Generation Sequencing Test (WAYFIND-R)

summary: WAYFIND-R is a registry that aims to capture high-quality real-world data linking next-generation sequencing, treatments and outcomes from cancer patients diagnosed with a solid tumour. The WAYFIND-R has three main overarching objectives: 1. To provide a platform to support the design and conduct of clinical and epidemiological research; 2. To develop an evidence-generation platform to better understand health outcomes and cancer care processes; and 3. To characterize the treatments and clinical course of solid tumor cancers in patients who have undergone NGS testing.

study_type: Observational

time_perspective: Prospective

ipd_sharing_description: Qualified researchers may be granted access to individual patient-level data through the data sharing environment of the Registry.

location_country:
Serbia
Spain
South Africa
Poland
Portugal
Slovenia
Argentina
Israel
Turkey
Mexico
Slovakia
Brazil
Canada
Germany
Taiwan
Greece
Ireland
Estonia
Thailand
France
Chile
Colombia

location_facility: Medizinische Hochschule Hannover; Klinik für Gastroenterologie, Hepatologie und Endokrinologie

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

location_facility: Hospital Universitario Son Espases; Servicio de Oncologia

location_facility: East Tallinn Central Hospital; Clinic of Internal Medicine

location_facility: HELIOS Klinikum Bad Saarow; Klinik Hämatologie, Onkologie und Palliativmedizin, Sarkomzentrum

location_facility: Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Oddzial Badan Wczesnych Faz

location_facility: Fundacion Jimenez Diaz; Servicio de Oncologia

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

location_facility: Sourasky / Ichilov Hospital; Dept. of Oncology

location_facility: HM Sanchinarro - CIOCC; Servicio de Oncologia

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: Medicana International Atasehir Hospital

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: North Estonia Medical Centre Foundation; Oncology Center

location_facility: Medical Oncology Centre of Rosebank; Oncology

location_facility: Bağcılar Medipol Mega Üniversite Hastanesi; Oncology

location_facility: Clínica Integral Internacional de Oncología S de RL de CV

location_facility: Katharinenhospital Stuttgart; Klinik für Hämatologie, Onkologie und Palliativmedizin

location_facility: Metropolitan Hospital Fourth Oncology Clinic

location_facility: Institut Hospitalier Franco-Britannique; Cancerologie

location_facility: Marien-Hospital Wesel; Klinik für Gastro., Onko. + Häma., Diabetologie und Rheumatologie

location_facility: Acıbadem Adana Hospital, Oncology Department

location_facility: Narodny Onkologicky Ustav; Oddelenie klinickej onkologie A

location_facility: Hospital da Luz; Departamento de Oncologia Medica


title: An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined With Ruxolitinib in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV-MF), Or Post-Essential Thrombocythemia MF (Post ET-MF) Who Have a Suboptimal Response to Ruxolitinib

summary: This is a phase 1b/2 study of KRT-232 combined with ruxolitinib in subjects with MF who have a suboptimal response after at least 18 weeks of treatment with ruxolitinib. The primary objective of the study is to determine a recommended phase 2 dose (RP2D) of KRT 232 in combination with ruxolitinib.

lead_sponsor: Kartos Therapeutics, Inc.

location_country:
Poland
Spain
Italy
Australia
United States
France
Israel
Germany
Bulgaria

location_facility: d'Hebron University Hospital in Barcelona

location_facility: University Mutiprofile Hospital Alexandrovska

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

location_facility: Ospedale di Circolo e Fondazione MacchiASST Sette Laghi

location_facility: Universitätsklinikum Aachen Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation

location_facility: Szpital Wojewódzki w Opolu Sp zooOddzial Kliniczny Hematologii

location_facility: Department für Innere Medizin Universitätsklinik und Poliklinik für Innere Medizin IV Hämatologie/Onkologie

location_facility: UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz III. Med. Klinik und Poliklinik

location_facility: Bologna University Hospital, Institute of Hematology

location_facility: Oddział Kliniczny Hematologii Szpitala Uniwersyteckiego w Krakowie

location_facility: Hospital Universitario Germans Trias i Pujol


title: A Phase 3 Randomized, Open-label Study to Evaluate the Efficacy and Safety of Olaparib Alone or in Combination With Bevacizumab Compared to Bevacizumab With a Fluoropyrimidine in Participants With Unresectable or Metastatic Colorectal Cancer Who Have Not Progressed Following First-line Induction (LYNK-003)

lead_sponsor: Merck Sharp & Dohme LLC

type: Registry Identifier

ReferenceType: derived

ReferenceCitation: Kim TW, Taieb J, Gurary EB, Lerman N, Cui K, Yoshino T. Olaparib with or without bevacizumab or bevacizumab and 5-fluorouracil in advanced colorectal cancer: Phase III LYNK-003. Future Oncol. 2021 Dec;17(36):5013-5022. doi: 10.2217/fon-2021-0899. Epub 2021 Nov 15.

location_country:
Spain
Colombia
Latvia
Australia
Russian Federation
Canada
Lithuania
Ukraine
Hungary
Korea, Republic of
United States
Chile
France
South Africa
Belgium
Japan
Germany
Turkey

location_facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 1304)

location_facility: Peninsula Health Frankston Hospital ( Site 0056)

location_facility: Severance Hospital Yonsei University Health System ( Site 0951)

location_facility: Medical center Medikal Plaza of Ecodnipro LLC ( Site 1317)

location_facility: Hospital Universitario Gregorio Maranon ( Site 1152)

location_facility: Hacettepe University Faculty of Medicine ( Site 1200)

location_facility: Medical Center Asklepion LLC ( Site 1309)

location_facility: Zala Megyei Szent Rafael Korhaz ( Site 1429)

location_facility: Baylor Scott & White Medical Center - Temple ( Site 1397)

location_facility: Dr. Everett Chalmers Regional Hospital ( Site 0204)

location_facility: Sandton Oncology Medical Group PTY LTD ( Site 0900)

location_facility: Daugavpils Regional Hospital ( Site 1502)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 0655)

location_facility: University Cancer & Blood Center, LLC ( Site 1381)

location_facility: West Cancer Center - East Campus ( Site 1396)

location_facility: Seoul National University Hospital ( Site 0950)

location_facility: Trakya Universitesi Tip Fakultesi ( Site 1210)

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1427)

location_facility: Instituto Nacional de Cancerologia E.S.E ( Site 0362)

location_facility: Hopital Cite de la Sante de Laval ( Site 0203)

location_facility: Allegheny Singer Research Institute ( Site 1364)

location_facility: Administradora Country SA - Clinica del Country ( Site 0350)

location_facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0353)

location_facility: New England Cancer Specialists ( Site 1422)

location_facility: Aichi Cancer Center Hospital ( Site 0658)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 0654)

location_facility: Medical center of the Limited Liability Company Yulis ( Site 1314)

location_facility: St. Vincent Frontier Cancer Center-Research ( Site 1414)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 0652)

location_facility: The Cancer Institute Hospital of JFCR ( Site 0659)

location_facility: MEDSI Clinical Hospital on Pyatnitsky Highway-Departmentof Antitumor Drug therapy ( Site 1129)

location_facility: Kyungpook National University Chilgok Hospital ( Site 0956)

location_facility: GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 1130)

location_facility: Kartal Dr. Lutfi Kirdar Egitim ve Arast Hast ( Site 1211)

location_facility: Hospital Universitario Central de Asturias ( Site 1153)

location_facility: C.H.U. de Strasbourg Hopital de Hautepierre ( Site 0464)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1121)

location_facility: UC Health Memorial Hospital ( Site 1401)

location_facility: Ege Universitesi Tip Fakultesi Tulay Aktas Onkoloji Hastanesi ( Site 1204)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 1426)

location_facility: Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0504)

location_facility: First Moscow State Medical University n.a. I.M.Sechenov ( Site 1127)

location_facility: National Cancer Center Hospital ( Site 0651)

location_facility: Vilniaus Universiteto Ligonine Santaros Klinikos ( Site 1526)

location_facility: St. Marianna University School of Medicine Hospital ( Site 0657)

location_facility: National Cancer Center Hospital East ( Site 0650)

location_facility: Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 1432)

location_facility: Providence Saint Joseph Medical Center, Disney Family Cancer ( Site 1392)

location_facility: Providence Portland Medical Center ( Site 1400)

location_facility: The Catholic University of Korea St. Mary s Hospital ( Site 0953)

location_facility: Poudre Valley Health System ( Site 1402)

location_facility: P. Stradina Clinical University Hospital ( Site 1500)

location_facility: McGill University Health Centre ( Site 0207)

location_facility: National Medical and Surgical Center n.a. N.I.Pirogov ( Site 1126)

location_facility: Inonu Universitesi Medical Fakultesi ( Site 1207)

location_facility: Hospital 12 de Octubre de Madrid ( Site 1150)

location_facility: Gazi Universitesi Tip Fakultesi ( Site 1215)

location_facility: Cancer Partners of Nebraska ( Site 1353)

location_facility: Vanderbilt University Medical Center ( Site 1362)

location_facility: University Medical Center New Orleans ( Site 1365)

location_facility: Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 1319)

location_facility: Princess Margaret Cancer Centre ( Site 0209)

location_facility: MROI n.a. P.A. Herzen - branch of FSBI NMICR of MoH of Russia ( Site 1128)

location_facility: Washington University in St. Louis ( Site 1384)

location_facility: Hopital Europeen Georges Pompidou ( Site 0452)

location_facility: Cancer & Hematology Centers of Western Michigan ( Site 1358)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 1214)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1202)

location_facility: Hattiesburg Clinic Hematology/Oncology ( Site 1418)

location_facility: Korea University Anam Hospital ( Site 0955)

location_facility: Centro Investigación del Cáncer James Lind ( Site 0251)

location_facility: Hospital General Universitario de Elche ( Site 1155)

location_facility: Shalimov s NI of Surgery and Transplantation ( Site 1321)

location_facility: Clínica San Carlos de Apoquindo Red Salud UC Christus ( Site 0252)

location_facility: Moncton Hospital - Horizon Health Network ( Site 0201)

location_facility: James Graham Brown Cancer Center ( Site 1393)

location_facility: St. Josef und St. Elisabeth Hospital gGmbH-Hematology, oncology and palliative medicine ( Site 0503)

location_facility: St Joseph Heritage Healthcare-Oncology ( Site 1383)

location_facility: Oregon Health & Science University ( Site 1411)

location_facility: Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0455)

location_facility: Orszagos Onkologiai Intezet ( Site 1431)

location_facility: City Clinical Oncology Center ( Site 1114)

location_facility: Cancercare Rondebosch Oncology ( Site 0904)

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 1203)

location_facility: CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0202)

location_facility: Nacionalinis Vezio Institutas ( Site 1527)

location_facility: Riga East Clinical University Hospital ( Site 1501)

location_facility: Arkhangelsk Clinical Oncological Dispensary ( Site 1113)

location_facility: Baskent University Adana Training Hospital ( Site 1205)

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás Ce

location_facility: Prof. Dr. Cemil Tascioglu Sehir Hastanesi ( Site 1216)

location_facility: Royal Brisbane and Women s Hospital ( Site 0054)

location_facility: Fundacion Cardiovascular de Colombia ( Site 0360)

summary: This is an efficacy and safety study of olaparib alone or in combination with bevacizumab being compared to bevacizumab with a fluoropyrimidine in participants with unresectable or metastatic colorectal cancer who have not progressed following first-line induction. The primary hypotheses are: Olaparib + Bevacizumab is superior to a fluoropyrimidine + Bevacizumab with respect to progression-free survival (PFS) using Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR); Olaparib is superior to a fluoropyrimidine + Bevacizumab with respect to PFS using RECIST 1.1 as assessed by BICR. As of amendment 5 study enrollment is being discontinued and study participants randomized to one of the two experimental arms (olaparib plus bevacizumab or olaparib monotherapy) must discontinue study intervention. Participants who are still on study treatment will no longer have tumor response assessments by BICR.


acronym: REEF-IT

title: A Phase 2, Randomized, Open-label, Multicenter Study to Evaluate Efficacy, Pharmacokinetics, Safety, and Tolerability of Treatment With JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog With or Without JNJ-56136379 in Treatment-naive Patients With HBeAg Positive Chronic Hepatitis B Virus Infection

lead_sponsor: Janssen Research & Development, LLC

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

location_country:
Taiwan
Spain
United Kingdom
Russian Federation
Canada
United States
France
Turkey
Japan
Germany

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: Ege University Medical of Faculty, Department of Gastroenterology

location_facility: Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: NHS Greater Glasgow and Clyde - Gartnavel General Hospital

location_facility: Karadeniz Teknik University Medical Faculty

location_facility: Republic Clinical Infectious Hospital n.a. AF Agafonov

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

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

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

summary: The purpose of this study is to evaluate the efficacy of a treatment regimen of JNJ-73763989 + pegylated interferon alpha-2a (PegIFN-alpha-2a) + nucleos(t)ide analog (NA).


title: A Phase 3 Randomized Study of Loncastuximab Tesirine Combined With Rituximab Versus Immunochemotherapy in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (LOTIS-5)

acronym: LOTIS 5

summary: The purpose of this study is to evaluate the efficacy of loncastuximab tesirine (ADCT-402) combined with rituximab compared to standard immunochemotherapy.

lead_sponsor: ADC Therapeutics S.A.

location_country:
Poland
Spain
Italy
United Kingdom
Canada
Switzerland
United States
France
China
Israel
Belgium
Czechia

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Medical College of Wisconsin Cancer Center Clinical Trials Office

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas

location_facility: Centre de Lutte Contre le Cancer - Centre Henri-Becquerel

location_facility: Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan

location_facility: Comprehensive Cancer Centers of Nevada - Henderson

location_facility: University of California San Diego Moores Cancer Center

location_facility: Zhujiang Hospital of Southern Medical University

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

location_facility: Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

location_facility: Centre Hospitalier Regional Universitaire Brest

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

location_facility: Institute of Hematology and Blood Diseases Hospital of CAMS - PUMC

location_facility: Centre Hospitalier Universitaire Universite Catholique de Louvain

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Algemeen Ziekenhuis Delta - Campus Rumbeke

location_facility: Szpitale Pomorskie Spółka Z Ograniczoną Odpowiedzialnością

location_facility: Samson Assuta Ashdod University Hospital

location_facility: Istituto Oncologico della Svizzera Italiana

location_facility: Kaiser Permanente Interstate Medical Office Central

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Research Institute of the McGill University Health Centre

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

location_facility: CHU Dijon Bourgogne - Hôpital François Mitterrand


status: Completed

title: An Adaptive Phase 3, Randomized, Double-blind, Placebo-controlled Study Assessing Efficacy and Safety of Sarilumab for Hospitalized Patients With COVID19

study_completion_date_type: Actual

lead_sponsor: Sanofi

ReferenceCitation: Lescure FX, Honda H, Fowler RA, Lazar JS, Shi G, Wung P, Patel N, Hagino O; Sarilumab COVID-19 Global Study Group. Sarilumab in patients admitted to hospital with severe or critical COVID-19: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2021 May;9(5):522-532. doi: 10.1016/S2213-2600(21)00099-0. Epub 2021 Mar 4.

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

location_country:
Brazil
Spain
Italy
Russian Federation
Argentina
Canada
France
Chile
Israel
Japan
Germany

location_facility:
Investigational Site Number 6430002
Investigational Site Number 2500002
Investigational Site Number 0760005
Investigational Site Number 1520004
Investigational Site Number 2500003
Investigational Site Number 0320003
Investigational Site Number 3800002
Investigational Site Number 3920002
Investigational Site Number 3760002
Investigational Site Number 2500001
Investigational Site Number 1520002
Investigational Site Number 3760001
Investigational Site Number 3800006
Investigational Site Number 2760002
Investigational Site Number 3920003
Investigational Site Number 1240003
Investigational Site Number 1520003
Investigational Site Number 2500007
Investigational Site Number 2500006
Investigational Site Number 2500005
Investigational Site Number 1240005
Investigational Site Number 0760003
Investigational Site Number 3920001
Investigational Site Number 1520001
Investigational Site Number 1240001
Investigational Site Number 6430003
Investigational site number 3760003
Investigational Site Number 7240003
Investigational Site Number 7240001
Investigational Site Number 0760002
Investigational Site Number 0760004
Investigational Site Number 2500004
Investigational Site Number 3800003
Investigational Site Number 6430001
Investigational Site Number 0320001
Investigational Site Number 3800005
Investigational Site Number 3800004
Investigational Site Number 1240002
Investigational Site Number 0760001
Investigational Site Number 7240002
Investigational Site Number 1240004
Investigational Site Number 2760001
Investigational Site Number 3800001
Investigational Site Number 2760004
Investigational Site Number 7240004
Investigational Site Number 0320004
Investigational Site Number 7240005

summary:
Primary Objective:

To evaluate the clinical efficacy of sarilumab relative to the control arm in adult participants hospitalized with severe or critical Coronavirus Disease 2019 (COVID-19).

Secondary Objectives:

Evaluate the 28-day survival rate.
Evaluate the clinical efficacy of sarilumab compared to the control arm by clinical severity.
Evaluate changes in the National Early Warning Score 2.
Evaluate the duration of predefined symptoms and signs (if applicable).
Evaluate the duration of supplemental oxygen dependency (if applicable).
Evaluate the incidence of new mechanical ventilation use during the study.
Evaluate the duration of new mechanical ventilation use during the Study.
Evaluate the proportion of participants requiring rescue medication during the 28-day period.
Evaluate need for admission into intensive care unit.
Evaluate duration of hospitalization (days).

The secondary safety objectives of the study were to evaluate the safety of sarilumab through hospitalization (up to Day 29 if participant was still hospitalized) compared to the control arm as assessed by incidence of:

Serious adverse events.
Major or opportunistic bacterial or fungal infections in participants with grade 4 neutropenia.
Grade greater than or equal to (>=) 2 infusion related reactions.
Grade >=2 hypersensitivity reactions.
Increase in alanine transaminase (ALT) >=3X upper limit of normal (ULN) (for participants with normal baseline) or greater than 3X ULN AND at least 2-fold increase from baseline value (for participants with abnormal baseline).
Major or opportunistic bacterial or fungal infections.

status_simplified: Completed


acronym: COVACTA

title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia

ReferenceCitation: Rosas IO, Bräu N, Waters M, Go RC, Malhotra A, Hunter BD, Bhagani S, Skiest D, Savic S, Douglas IS, Garcia-Diaz J, Aziz MS, Cooper N, Youngstein T, Sorbo LD, Zerda DJ, Ustianowski A, Gracian AC, Blyth KG, Carratalà J, François B, Benfield T, Haslem D, Bonfanti P, van der Leest CH, Rohatgi N, Wiese L, Luyt CE, Bauer RN, Cai F, Lee IT, Matharu B, Metcalf L, Wildum S, Graham E, Tsai L, Bao M. Tocilizumab in patients hospitalised with COVID-19 pneumonia: Efficacy, safety, viral clearance, and antibody response from a randomised controlled trial (COVACTA). EClinicalMedicine. 2022 May;47:101409. doi: 10.1016/j.eclinm.2022.101409. Epub 2022 Apr 21.

ReferenceCitation: Tom J, Bao M, Tsai L, Qamra A, Summers D, Carrasco-Triguero M, McBride J, Rosenberger CM, Lin CJF, Stubbings W, Blyth KG, Carratalà J, François B, Benfield T, Haslem D, Bonfanti P, van der Leest CH, Rohatgi N, Wiese L, Luyt CE, Kheradmand F, Rosas IO, Cai F. Prognostic and Predictive Biomarkers in Patients With Coronavirus Disease 2019 Treated With Tocilizumab in a Randomized Controlled Trial. Crit Care Med. 2022 Mar 1;50(3):398-409. doi: 10.1097/CCM.0000000000005229.

ReferenceCitation: Rosas IO, Bräu N, Waters M, Go RC, Hunter BD, Bhagani S, Skiest D, Aziz MS, Cooper N, Douglas IS, Savic S, Youngstein T, Del Sorbo L, Cubillo Gracian A, De La Zerda DJ, Ustianowski A, Bao M, Dimonaco S, Graham E, Matharu B, Spotswood H, Tsai L, Malhotra A. Tocilizumab in Hospitalized Patients with Severe Covid-19 Pneumonia. N Engl J Med. 2021 Apr 22;384(16):1503-1516. doi: 10.1056/NEJMoa2028700. Epub 2021 Feb 25.

ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the clinical study data request platform https://vivli.org.

Further details on Roche's criteria for eligible studies are available here: https://vivli.org.

For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here: (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm

location_country:
Denmark
Spain
Italy
United Kingdom
Netherlands
Canada
United States
France
Germany

location_facility: Rigshospitalet Copenhagen University Hospital

location_facility: University of Miami Miller School of Medicine

location_facility: Centre Hospitalier et Universitaire de Limoges

location_facility: Azienda Ospedaliera San Gerardo di Monza

location_facility: Cleveland Clinic Foundation; Pulmonary, Allergy & Critical Care Medicine

location_facility: Hospital Universitario HM Sanchinarro-CIOCC

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Fondazione IRCCS Policlinico San Matteo di Pavia; S.S. Fisiopatologia Respiratoria

location_facility: James J Peters Veterans Administration Medical Center - NAVREF

location_facility: Centre Hospitalier Departemental de Vendee

location_facility: Universitätsklinikum Köln; Innere Medizin I; Onkologie, Hämatologie

location_facility: Robert Wood Johnson University Hospital/Rutgers

summary: This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of tocilizumab (TCZ) compared with a matching placebo in combination with standard of care (SOC) in hospitalized patients with severe COVID-19 pneumonia.


title: A Phase III, Randomized, Double-Blinded, Placebo-Controlled Study of Tiragolumab, an Anti-Tigit Antibody, in Combination With Atezolizumab Compared With Placebo in Combination With Atezolizumab in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer

summary: The purpose of the study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in participants with previously untreated locally advanced, unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. Eligible participants will be randomized in a 1:1 ratio to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab.

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

location_country:
Serbia
Spain
Italy
Ukraine
United States
Peru
Japan
Poland
Austria
Australia
Russian Federation
Argentina
Turkey
Mexico
Brazil
Switzerland
Hungary
China
Germany
Denmark
Taiwan
Greece
Thailand
Korea, Republic of
France
Netherlands

location_facility: CEMER Centro Medico de Enfermedades Respiratorias

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

location_facility: Chonnam National University Hwasun Hospital

location_facility: Kantonsspital St.Gallen Medizin Onkologie; Klinik fuer Onkologie und Haematologie

location_facility: Warminsko-Mazurskie Centrum Chorób Płuc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii

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

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

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica

location_facility: Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga; SSD Oncologia Polomonare (II PAD. IV PIANO)

location_facility: University Hospital Medical Center Bezanijska kosa

location_facility: Istanbul University Cerrahpasa Faculty of Medicine

location_facility: Ivano-Frankivsk Regional Oncology Center

location_facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin I

location_facility: Northwest Cancer Specialists - Vancouver

location_facility: Chang Gung Memorial Hospital - Linkou Branch

location_facility: Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine

location_facility: Harbin Medical University Cancer Hospital

location_facility: Cancer Center of Guangzhou Medical University

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy

location_facility: Taipei Medical University -Shuang Ho Hospital

location_facility: Institute for pulmonary diseases of Vojvodina

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

location_facility: A.O. Universitaria Di Parma; Oncologia Medica

location_facility: Beijing Chest Hospital; Oncology Department

location_facility: Sjællands Universitetshospital, Roskilde; Klinisk Onkologisk Afdeling og Palliativ Enhed

location_facility: Uzhgorod Nat. University Central Municip Hosp; Onc Center

location_facility: Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

location_facility: Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie

location_facility: Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia

location_facility: University Hospital of Larissa;Department of Medical Oncology

location_facility: SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein; Onk & Pal

location_facility: National Cheng Kung Uni Hospital; Dept of Hematology and Oncology

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

location_facility: Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology

location_facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház; Onkológiai Osztály

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

location_facility: National Taiwan University Hospital; Oncology

location_facility: Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory

location_facility: Taichung Veterans General Hospital; Dept of Internal Medicine

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Hospital 12 de Octubre; Servicio de Digestivo

location_facility: Klinik Schillerhöhe; Pneumologische Onkologie

location_facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University

location_facility: The 1st Affiliated Hospital of Nanchang Unversity

location_facility: Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi

location_facility: Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

location_facility: SMZ - Baumgartner Hohe, Otto-Wagner-Spital; 2.Interne Lungenabteilung

location_facility: Instituto Regional de Enfermedades Neoplásicas del Sur; Centro de Inv. de Medicina Oncológica

location_facility: Hospital General Universitario de Alicante

location_facility: Severance Hospital, Yonsei University Health System

location_facility: US oncology research at Minnesota Oncology

location_facility: Univ General Hosp Heraklion; Medical Oncology

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

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: St. Petersburg Clinical Scientific Center of special services medical assis (oncology)

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: St. Petersburg Med Univ; n.a. I.P. Pavlov; Pulmonology Research

location_facility: Centre Georges Francois Leclerc; Recherche Clinique

location_facility: Centre Hospitalier Intercommunal; Service de Pneumologie

location_facility: Inselspital Bern; Universitätsklinik für medizinische Onkologie

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: Main Military Clinical Hospital named after N.N. Burdenko

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

location_facility: Seoul National University Bundang Hospital

location_facility: Austin Hospital Olivia Newton John Cancer Centre

location_facility: Hospital Regional Universitario de Malaga

location_facility: Sir Run Run Shaw Hospital Zhejiang University

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica

location_facility: Institut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest

location_facility: Virginia Cancer Specialists (Fairfax) - USOR

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

location_facility: Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia

location_facility: Inonu University Medical Faculty of Medicine; Medical Oncology Department

location_facility: Veszprem Megyei Onkormanyzat Tudogyogyintezete; Tudogyogyaszati Ambulancia

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet

location_facility: Adana Baskent University Hospital; Medical Oncology

location_facility: Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology

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

location_facility: Hospital Universitario Germans Trias i Pujol


title: Development and Validation of a Multidimensional System to Dynamically Predict Graft Survival After Kidney Transplantation

acronym: DYNAKT

summary:
The incidence of end stage renal disease (ESRD) is rapidly increasing, now affecting an estimated 7.4 million people worldwide. Numerous parameters such as demographic, clinical and functional factors drive the deterioration of the kidney, ultimately leading to ESRD. Although some ESRD prediction models have been derived in the past years, none of these models are dynamic: they do not integrate the repeated measurements recorded throughout individuals' follow-up.

As highlighted in several studies, kidney function repeated measurements (i.e., trajectories) are highly associated with graft survival after kidney transplantation. The investigators made the hypothesis that these trajectories may bring relevant information in the context of graft survival risk prediction model. Hence, combining these trajectories with standard graft survival risk factors may enhance prediction performance. This could permit to derive a robust tool that could be updated over time by continuously capturing patient' personal evolution.

ReferenceCitation: Raynaud M, Aubert O, Divard G, Reese PP, Kamar N, Yoo D, Chin CS, Bailly É, Buchler M, Ladrière M, Le Quintrec M, Delahousse M, Juric I, Basic-Jukic N, Crespo M, Silva HT Jr, Linhares K, Ribeiro de Castro MC, Soler Pujol G, Empana JP, Ulloa C, Akalin E, Böhmig G, Huang E, Stegall MD, Bentall AJ, Montgomery RA, Jordan SC, Oberbauer R, Segev DL, Friedewald JJ, Jouven X, Legendre C, Lefaucheur C, Loupy A. Dynamic prediction of renal survival among deeply phenotyped kidney transplant recipients using artificial intelligence: an observational, international, multicohort study. Lancet Digit Health. 2021 Dec;3(12):e795-e805. doi: 10.1016/S2589-7500(21)00209-0. Epub 2021 Oct 28.

lead_sponsor: Paris Translational Research Center for Organ Transplantation

location_country:
Croatia
Brazil
Spain
Argentina
United States
Chile
France

location_facility: Division of Transplantation, Department of Surgery, Feinberg School of Medicine, Northwestern University

location_facility: Albert Einstein College of Medicine, Renal Division Montefiore Medical Center, Kidney Transplantation Program

location_facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Renal Transplantation Service

location_facility: Department of Nephrology, Centre Hospitalier Universitaire de Montpellier

location_facility: Department of Medicine, Division of Nephrology, Comprehensive Transplant Center, Cedars Sinai Medical Center

location_facility: Nephrology Dialysis Transplantation Department, University of Lorraine, Centre Hospitalier Universitaire de Nancy

location_facility: Department of Transplantation, Nephrology and Clinical Immunology, Hôpital Foch

location_facility: Department of Surgery, Johns Hopkins University School of Medicine

location_facility: William J. von Liebig Center for Transplantation and Clinical Regeneration, Mayo Clinic

location_facility: Department of Nephrology and Organ Transplantation, Centre Hospitalier Universitaire Rangueil

location_facility: Department of Nephrology, Arterial Hypertension, Dialysis and Transplantation, University Hospital Centre Zagreb, School od Medicine University of Zagreb

location_facility: Kidney Transplant Department, Necker Hospital, Assistance Publique - Hôpitaux de Paris

location_facility: Bretonneau Hospital, Nephrology and Immunology Department

location_facility: Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris

location_facility: Department of Nephrology, Hospital del Mar

location_facility: Unidad de Trasplante Renopáncreas, Centro de Educación Médica e Investigaciones Clínicas

location_facility: Universidade Federal de São Paulo, Hospital do Rim, Escola Paulista de Medicina

intervention_type: Other


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

acronym: BE HEARD I

summary: The purpose of the study is to evaluate the efficacy and safety of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

lead_sponsor: UCB Biopharma SRL

location_country:
Denmark
Spain
Greece
Italy
Australia
Netherlands
Canada
Switzerland
United States
France
Israel
Turkey
Belgium
Norway
Germany


acronym: DOR/ISL Open-Label Switch

title: A Phase 3 Randomized, Active-Controlled, Open-Label Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL) Once-Daily in Participants With HIV-1 Virologically Suppressed on Antiretroviral Therapy

location_country:
Poland
Spain
Italy
Russian Federation
Australia
New Zealand
Canada
United Kingdom
Switzerland
United States
Chile
France
South Africa
Colombia
Japan

location_facility: CHU de Bordeaux- Hopital Saint Andre ( Site 2015)

location_facility: Universitaetsspital Zuerich ( Site 3300)

location_facility: FGU Republican Clinical Infectious Hospital of Roszdrav ( Site 1700)

location_facility: Desmond Tutu HIV Foundation Clinical Trial Unit ( Site 1414)

location_facility: Hospital Universitari Germans Trias i Pujol ( Site 1606)

location_facility: Melbourne Sexual Health Centre ( Site 2305)

location_facility: Krasnoyarsk Regional Center for Prevention and Control of AIDS ( Site 1712)

location_facility: Brighton and Sussex University Hospital NHS Trust ( Site 1908)

location_facility: Tokyo Medical University Hospital ( Site 2404)

location_facility: Federal Scientific Methodological AIDS Prevention and Control Center ( Site 1703)

location_facility: ASST Fatebenefratelli-Ospedale Sacco ( Site 2200)

location_facility: Policlinico Gemelli Instituto di Clinica Chirurgica ( Site 2206)

location_facility: Vancouver ID Research and Care Centre Society ( Site 1100)

location_facility: Clinique de Medecine Urbaine du Quartier Latin ( Site 1104)

location_facility: Kansas City CARE Health Center ( Site 1008)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 1603)

location_facility: Saint Petersburg Center for Prophylactic of AIDS and Inf. Diseases ( Site 1701)

location_facility: Hospital Dr. Hernan Henriquez Aravena ( Site 1305)

location_facility: National Hospital Organization Nagoya Medical Center ( Site 2403)

location_facility: Tokyo Metropolitan Komagome Hospital ( Site 2406)

location_facility: Center Hospital of the National Center for Global Health and Medicine ( Site 2401)

location_facility: Infectious Clinical Hospital #2 ( Site 1719)

location_facility: Centro de Investigacion Clinica UC CICUC ( Site 1303)

location_facility: Royal Brisbane and Womens Hospital- Infectious Diseases Unit ( Site 2309)

location_facility: Hopital Francois Mitterrand ( Site 2019)

location_facility: SP ZOZ Wojewodzki Szpital Zakazny ( Site 1505)

location_facility: Inselspital Universitaetsspital Bern ( Site 3303)

location_facility: CHU de Toulouse - Hopital Purpan ( Site 2004)

location_facility: North Texas ID Consultants, PA ( Site 1003)

location_facility: A.P.H. Paris, Hopital Saint Louis ( Site 2014)

location_facility: Kemerovo Regional Center for the Prevention and Control of AIDS ( Site 1713)

location_facility: Saint Hope Foundation, Inc. ( Site 1037)

location_facility: Texas Centers for Infectious Disease Associates P.A. ( Site 1022)

location_facility: Midway Immunology and Research ( Site 1030)

location_facility: EMC Instytut Medyczny SA Przychodnia przy ul. Lowieckiej we Wroclawiu ( Site 1500)

location_facility: Wroclawskie Centrum Zdrowia SP ZOZ ( Site 1507)

location_facility: Regional Center for Prevent. and Control of AIDS and Inf. Diseases ( Site 1715)

location_facility: Hospital Universitario La Paz ( Site 1604)

location_facility: Ospedale Regionale di Lugano Civico ( Site 3305)

location_facility: Hopitaux Universitaires de Geneve HUG. ( Site 3304)

location_facility: North Manchester General Hospital ( Site 1902)

location_facility: Wojewodzki Szpital Specjalistyczny im. dr. Wladyslawa Bieganskiego ( Site 1503)

location_facility: Hospital Universitario Fundacion Jimenez Diaz ( Site 1602)

location_facility: University of North Carolina at Chapel Hill ( Site 1042)

location_facility: Hospital Universitario Infanta Leonor ( Site 1601)

location_facility: Republican Clinical Hospital of Infectious Diseases n. a. A.F.Agafonov ( Site 1707)

location_facility: Hospital Clinic i Provincial ( Site 1600)

location_facility: National Hospital Organization Osaka National Hospital ( Site 2402)

location_facility: Kings College Hospital NHS Foundation Trust ( Site 1907)

location_facility: A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 2208)

location_facility: Toronto General Hospital - University Health Network ( Site 1105)

location_facility: The Crofoot Research Center, Inc. ( Site 1005)

location_facility: Triple O Research Institute, P.A. ( Site 1026)

location_facility: Holdsworth House Medical Practice ( Site 2300)

location_facility: Georgetown University Hospital ( Site 1018)

location_facility: Southern Alberta HIV Clinic ( Site 1108)

location_facility: Chatham County Health Department ( Site 1043)

summary: This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected participants virologically suppressed on a protocol-specified background antiretroviral regimen. The primary hypothesis is that a switch to MK-8591A will be non-inferior to continued treatment with baseline antiretroviral therapy (ART) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48.


acronym: PACIFIC-AF

title: Multicenter, Randomized, Active Comparator-controlled, Double-blind, Double-dummy, Parallel Group, Dose-finding Phase 2 Study to Compare the Safety of the Oral FXIa Inhibitor BAY2433334 to Apixaban in Patients With Atrial Fibrillation

lead_sponsor: Bayer

ReferenceCitation: Piccini JP, Caso V, Connolly SJ, Fox KAA, Oldgren J, Jones WS, Gorog DA, Durdil V, Viethen T, Neumann C, Mundl H, Patel MR; PACIFIC-AF Investigators. Safety of the oral factor XIa inhibitor asundexian compared with apixaban in patients with atrial fibrillation (PACIFIC-AF): a multicentre, randomised, double-blind, double-dummy, dose-finding phase 2 study. Lancet. 2022 Apr 9;399(10333):1383-1390. doi: 10.1016/S0140-6736(22)00456-1. Epub 2022 Apr 3.

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

location_country:
Spain
Italy
Austria
Latvia
United Kingdom
Canada
Switzerland
Sweden
Hungary
France
Belgium
Japan
Netherlands
Czechia

location_facility: University of Semmelweis/ Semmelweis Egyetem

location_facility: Institut universitaire de cardiologie et de pneumologie

location_facility: Riga East Clinical University Hospital "Gailezers"

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Ciutat Sanitària i Universitaria de la Vall d'Hebron

location_facility: Hôpital Cantonal Universitaire de Genève

location_facility: Institut Klinicke a Experimentalni Mediciny

location_facility: Hyogo Prefectural Harima-Himeji General Medical Center

location_facility: Medifarma-98 Egeszsegugyi, Kereskedelmi es Szolgaltato Kft.

location_facility: P. Stradins Clinical University Hospital

location_facility: Uniklinikum Salzburg - Landeskrankenhaus

location_facility: Csongrad-Csanad Megyei Dr. Bugyi Istvan Korhaz

location_facility: Ciutat Sanitària i Universitària de Bellvitge

location_facility: Centre Hospitalier Régional - Saint Brieuc

location_facility: Hospital de la Santa Creu i de Sant Pau | Cardiología

summary:
The purpose of this study is to try to find the best dose of the new drug BAY 2433334 to give to participants and to look at how well BAY 2433334 works in patients with irregular heartbeat (atrial fibrillation) that can lead to blood clots, stroke and other heart-related complications. In addition researchers want to compare the safety of the study drug to apixaban, a non-vitamin K oral anticoagulant (NOAC) in patients with atrial fibrillation. This study is also done to learn how the drug in this study moves into, through and out of the body. BAY 2433334, works by blocking a step of the blood clotting process in our body and thins the blood and is a so called oral FXIa inhibitor.

Apixaban, works by reducing the production of blood clotting factors in our body and thins the blood and is a so called non-vitamin K oral anticoagulant (NOAC). Thinning the blood can prevent you from blood clots which can cause a stroke.


title: An Open-label, Phase 2 Study Treating Subjects With First or Second Relapse of Multiple Myeloma With Carfilzomib, Pomalidomide, and Dexamethasone (KPd)

acronym: SELECT

summary: A Study Evaluating Treatment of Multiple Myeloma with Carfilzomib in Combination with Pomalidomide and Dexamethasone

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

lead_sponsor: Amgen

location_country:
Denmark
Spain
Greece
Italy
Estonia
United States
France
Germany

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

location_facility: Theagenion Cancer Hospital of Thessaloniki

location_facility: University General Hospital of Evros-Alexandroupolis District

location_facility: United States Oncology Regulatory Affairs Corporate Office

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino Ospedale Molinette

location_facility: General University Hospital of Patras Panagia i Voithia

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hôpital Haut Lévêque

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: US Oncology Research Investigational Products Center

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II

location_facility: Baylor Charles A Sammons Cancer Center at Dallas

location_facility: Institut Universitaire du Cancer Toulouse Oncopole

location_facility: General Hospital of Thessaloniki Georgios Papanikolaou

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

location_facility: Rocky Mountain Cancer Centers Denver Midtown


ipd_sharing: Undecided

acronym: ADVANCE

title: A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX 113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia (ITP)

lead_sponsor: argenx

location_country:
Poland
Spain
Italy
Austria
Georgia
Netherlands
Russian Federation
United Kingdom
Ukraine
Hungary
United States
France
Turkey
Belgium
Japan
Germany
Bulgaria
Czechia

location_facility:
Investigator Site 4200001
Investigator Site 0340009
Investigator site 0810016
Investigator Site 9950007
Investigator Site 0900003
Investigator Site 0430002
Investigator Site 0330019
Investigator Site 0010034
Investigator Site 0490010
Investigator Site 9950009
Investigator Site 0430003
Investigator Site 0320015
Investigator Site 0010045
Investigator Site 0330009
Investigator Site 4200008
Investigator Site 0900017
Investigator Site 0900014
Investigator Site 0480014
Investigator Site 0070007
Investigator Site 0390010
Investigator Site 9950006
Investigator Site 0900008
Investigator Site 0340014
Investigator Site 0480011
Investigator Site 0390009
Investigator Site 0390016
Investigator Site 0340015
Investigator Site 0430004
Investigator Site 0810024
Investigator Site 0490008
Investigator Site 0390015
Investigator Site 0330018
Investigator Site 0340006
Investigator site 3800006
Investigator Site 3800022
Investigator Site 0320014
Investigator site 0810018
Investigator Site 0480030
Investigator Site 0900009
Investigator Site 0900005
Investigator Site 0360015
Investigator Site 0340030
Investigator Site 0480012
Investigator Site 0440008
Investigator Site 0440010
Investigator Site 0360014
Investigator Site 0010046
Investigator Site 0010042
Investigator Site 0390019
Investigator Site 0340013
Investigator Site 9950012
Investigator site 0480026
Investigator Site 0070012
Investigator Site 4200006
Investigator Site 0390021
Investigator site 0360010
Investigator Site 0330015
Investigator Site 0340004
Investigator Site 0010038
Investigator site 0320002
Investigator Site 0390020
Investigator Site 0480013
Investigator Site 0390011
Investigator Site 0900018
Investigator Site 0900013
Investigator Site 0320020
Investigator Site 0070013
Investigator Site 0010040
Investigator Site 3590001
Investigator Site 0010049
Investigator Site 0480015
Investigator Site 0340007
Investigator Site 0900002
Investigator Site 0810021
Investigator Site 0900010
Investigator site 0340012
Investigator Site 0310005
Investigator site 0810017
Investigator Site 3590002
Investigator Site 0390018
Investigator Site 0390012
Investigator site 0010037
Investigator Site 0330008
Investigator Site 0360004
Investigator Site 0330016
Investigator site 0810014
Investigator Site 0900015
Investigator Site 0390017
Investigator Site 0330017
Investigator site 0310006
Investigator site 0810011
Investigator Site 4200007
Investigator Site 0440012
Investigator Site 0810025
Investigator Site 0440014
Investigator Site 0810023
Investigator site 0070010
Investigator site 0070006
Investigator site 0810020
Investigator Site 0810015
Investigator Site 0310007
Investigator Site 0390014
Investigator Site 0360006
Investigator Site 0900004
Investigator Site 0480008
Investigator Site 0010041
Investigator Site 0900007
Investigator Site 0340011
Investigator Site 0900006
Investigator Site 0810010
Investigator Site 0480016
Investigator Site 0320012
Investigator Site 9950011
Investigator Site 0900016
Investigator Site 0900019
Investigator Site 0810022
Investigator Site 0480010
Investigator Site 0490012
Investigator Site 0320011
Investigator Site 0070015
Investigator Site 9950008

summary: This is a randomized, double-blind placebo-controlled multicenter phase 3 trial to evaluate the efficacy and safety of ARGX-113 in patients with primary ITP.