ReferenceCitation: Awada A, Colomer R, Inoue K, Bondarenko I, Badwe RA, Demetriou G, Lee SC, Mehta AO, Kim SB, Bachelot T, Goswami C, Deo S, Bose R, Wong A, Xu F, Yao B, Bryce R, Carey LA. Neratinib Plus Paclitaxel vs Trastuzumab Plus Paclitaxel in Previously Untreated Metastatic ERBB2-Positive Breast Cancer: The NEfERT-T Randomized Clinical Trial. JAMA Oncol. 2016 Dec 1;2(12):1557-1564. doi: 10.1001/jamaoncol.2016.0237.

name: Medical Oncology Clinic, Institut Jules Bordet, Université Libre de Bruxelles, Bruxelles, Belgium

family: Awada

full_name: Ahmad Awada

given: Ahmad

name: Division of Medical Oncology, Hospital Universitario La Princesa, Madrid, Spain

family: Colomer

full_name: Ramon Colomer

given: Ramon

name: Division of Breast Oncology, Saitama Cancer Center, Ina, Japan

family: Inoue

full_name: Kenichi Inoue

given: Kenichi

name: Dnepropetrovsk State Medical Academy, Dnepropetrovsk, Ukraine

family: Bondarenko

full_name: Igor Bondarenko

given: Igor

family: Badwe

full_name: Rajendra A. Badwe

given: Rajendra A.

name: University of the Witwatersrand Department of Medical Oncology and Wits Donald Gordon Medical Centre, Johannesburg, South Africa

family: Demetriou

full_name: Georgia Demetriou

given: Georgia

name: National University Cancer Institute, Singapore, Singapore

family: Lee

full_name: Soo-Chin Lee

given: Soo-Chin

name: Central India Cancer Research Institute, Nagpur, India

family: Mehta

full_name: Ajay O. Mehta

given: Ajay O.

name: Asan Medical Center, University of Ulsan, Seoul, South Korea

full_name: Sung-Bae Kim

given: Sung-Bae

family: Bachelot

full_name: Thomas Bachelot

given: Thomas

name: B.P. Poddar Hospital and Medical Research Ltd, Kolkata, India

family: Goswami

full_name: Chanchal Goswami

given: Chanchal

name: Institute Rotary Cancer Hospital, AIIMS, New Delhi, India

family: Deo

full_name: Suryanarayan Deo

given: Suryanarayan

name: Washington University School of Medicine, St Louis, Missouri

family: Bose

full_name: Ron Bose

given: Ron

name: Puma Biotechnology Inc, Los Angeles, California

family: Wong

full_name: Alvin Wong

given: Alvin

family: Xu

full_name: Feng Xu

given: Feng

family: Yao

full_name: Bin Yao

given: Bin

family: Bryce

full_name: Richard Bryce

given: Richard

name: Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill

family: Carey

full_name: Lisa A. Carey

given: Lisa A.

lead_sponsor: Puma Biotechnology, Inc.

location_country:
Malaysia
Romania
Belgium
Australia
Denmark
Taiwan
Ukraine
India
Spain
Croatia
France
Japan
Lithuania
Poland
Canada
Korea, Republic of
South Africa
Hong Kong
Switzerland
Bulgaria
Malta
Hungary
Singapore
China
Bahamas
Portugal
Germany
United States
United Kingdom
Italy
Serbia
Israel
Belarus
Turkey
Latvia

acronym: NEFERTT

location_facility: Hematology Oncology Associates of Treasure Coast

location_facility: Szegedi Tudomanyegyetem Onkoterapias Klinika

location_facility: Orszagos Onkologiai Intezet "B" Belgyogyaszati osztaly

location_facility: Deenanath Mangeshkar Hospital and Research Centre

location_facility: Institution of Healthcare Grodno Regional Clinical Hospital

location_facility: Tokyo Metropolitan Cancer and Infectious Disease Center, Komagome Hospital

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Semmelweis Egyetem Radiologiai és Onkoterapias Klinika

location_facility: Complejo Hospitalario Universitario Santiago de Compostela

location_facility: Washington University School of Medicine Siteman Cancer Center

location_facility: Gaston Hematology and Oncology Associates

location_facility: Tazuke Kofukai Medical Research Institute Kitano Hospital

location_facility: Yonsei University Health System Severance Hospital

location_facility: Komunalnyy Zaklad Cherkasskyy Oblasnyy Onkologichnyy Dyspanser

location_facility: CHU Strasbourg Departement Oncologie & Hematologie Hopital Civil

location_facility: Meenakshi Mission Hospital and Research Centre

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

location_facility: Policlinico di Modena Oncologia ed Ematologia

location_facility: Sozialstiftung Bamberg Klinik fuer Haematologie und internistische Onkologie

location_facility: Piejuras Hospital, Liepajas Oncological Clinic

location_facility: Hakuaikai Medical Corporation Sagara Hospital

location_facility: Pauls Stradiņš Clinical University Hospital

location_facility: National Hospital Organization Mito Medical Center

location_facility: Chang Gung Medical Foundation, Linkou Branch

location_facility: UNIMED Medical Institute, Comprehensive Centre for Breast Diseases

location_facility: Hopital Charles, LeMoyne Le Centre Intégré de Cancérologie de la Montérégie

location_facility: Centre Leon Berard Departement de Cancerologie Medicale

location_facility: Bacs-Kiskun Megyei Onkormanyzat Korhaza Onkoradiologiai Kozpont

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: Institutul Oncologic Prof. Dr. Ion Chiricuţă

location_facility: Policlinico Universitario Campus Bio-Medico

location_facility: N.N. Aleksandrov National Cancer Center of Belarus

location_facility: Hospital da Luz Servico de Oncologia Medica

location_facility: Palm Beach Institute of Hematology and Oncology

location_facility: Rigshospitalet, Copenhagen, Onkologisk Klinik

location_facility: National Cancer Center, Center for Breast Cancer

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: Kaposi Mor Oktato Korhoz Onkologiai Centrum

location_facility: Kurume Daiichi Social Insurance Hospital

location_facility: Zakład Opieki Zdrowotnej MSW z Warmińsko, Mazurskim Centrum Onkologii

location_facility: Samaritan Hematology and Oncology Consultants

location_facility: Cancer Hospital, Chinese Academy of Medical Sciences

location_facility: Hospital Madrid Norte Sanchinarro Centro Integral Oncológico Clara Campal Ensayos Clínicos

location_facility: S.P. Grigoreva Institute of Medical Radiology Department of Chemotherapy

location_facility: Hospital of Lithuanian University of Health sciences

location_facility: Healthcare Institution Vitebsk Regional Clinical Oncology Dispensary

location_facility: Chinese People's Liberation Army General Hospital

location_facility: Institution Gomel Regional Clinical Oncology Dispensary

location_facility: Kantonsspital Winterthur Medizinische Onkologie

location_facility: National Hospital Organization Osaka National Hospital

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: National Institute of Cancer Department of Conseravtive Methods of Treatment

location_facility: Ege Universitesi Tip Fakultesi Tulay Aktas Onkoloji Hastanesi

location_facility: Donetsk Regional Antitumor Center Department of Pretumor Diseases and Tumor Treatment

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: Hopital Hotel Dieu, Service d'Oncologie Medicale, Bat B2, 5ieme

location_facility: State Oncological Regional Treatment and Diagnostic Center

location_facility: Chernivtsi Regional Oncology Centre Outpatient Department Bukovynian State Medical University Department of Oncology and Radiology

location_facility: Centre Hospitalier Régional de Trois-Rivières

location_facility: National University Hospital, National Cancer Institute

location_facility: Charleston Area Medical Center, Health, Education, and Research Institute

location_facility: Specialised Hospital of ActiveTreatment in Oncology, Clinic of Chemotherapy

location_facility: Peking Union Medical College Hospital of Chinese Academy of Medical Sciences

location_facility: Service d'Oncologie et de Radiotherapie, Polyclinique Francheville

location_facility: Guy's and St Thomas NHS Foundation Trust Management Offices 4th Floor Bermondsey Wing Guy's Hospital

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Southern Medical University Nanfang Hospital

location_facility: Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház

location_facility: North Broward Medical Center Cancer Center

location_facility: Ospedale San Giovanni Battista-Molinette

location_facility: The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army

location_facility: Fovarosi Onkormanyzat Szent Imre Korhaz Klinikai Onkologiai Profil

location_facility: University of Witwatersrand Oncology, Donald Gordon Medical Centre

location_facility: Groupe Hospitalier Paris Saint Joseph, Oncologie medicale

location_facility: Nacionalinis Vezio Institutas, Vilniaus Universiteto Onkologijos Institutas

location_facility: National Hospital Organization Beppu Medical Center

location_facility: Kobe City Medical Center General Hospital

location_facility: Medical University of South Carolina Hollings Cancer Center

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Ventura County Hematology-Oncology Specialists

location_facility: Spital STS AG Onkologiezentrum Thun - Berner Oberland

location_facility: Centre de Radiothérapie, Clinique Sainte Anne, Service d'Oncologie Libérale

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: Clinical Hospital Osijek, Department of Radiotherapy and Oncology

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Wojewodzki Oddzial

location_facility: District Dispensary for Oncology Diseases Internal Unit- Sofia EOOD

location_facility: District Dispensary for Oncology Diseases Internal Unit- Plovdiv EOOD

location_facility: Osaka Medical Center for Cancer and Cardiovascular Diseases

location_facility: The Valley Hospital, Luckow Pavilion Office of Oncology Clinical Trials

location_facility: Hospital Universitario Fundación Alcorcón

title: A Randomized, Open-Label, Two-Arm Study Of Neratinib Plus Paclitaxel Versus Trastuzumab Plus Paclitaxel As First-Line Treatment For ErbB-2-Positive Locally Recurrent Or Metastatic Breast Cancer

summary: This study is investigating the effects of an experimental drug (neratinib) in combination with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of women who have not received previous treatment for erbB-2-positive locally recurrent or metastatic breast cancer. The study will compare the effectiveness of each regimen in shrinking tumors and extending the lives of women with erbB-2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and as well as the quality of life of subjects receiving either regimen.


title: MEDICI - t(11;14) and BCL2 Expression in Patients With Multiple Myeloma: Prevalence, Stability Across Lines of Therapy and Concordance Across Sample Types

acronym: MEDICI

summary:
Multiple myeloma (MM) is a rare cancer caused by abnormal survival of plasma cells (blood cells). Most trial participants with MM relapse (cancer has come back) or become non- responsive to treatment and remission gets shorter after each line of treatment. This is a study to assess t(11;14) and BCL2 expression in adult participants with newly diagnosed and relapsed/refractory (R/R) MM.

Approximately 500 adult participants with newly confirmed or relapsed/refractory (R/R) multiple myeloma (MM) will be enrolled in around 15-20 countries.

Participants will receive standard of care while participating in this study. No drug will be administered as a part of this study.

Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide bone marrow and blood samples.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: AbbVie

location_country:
Greece
Romania
Australia
Taiwan
Croatia
France
Poland
Norway
Argentina
Canada
Slovenia
Saudi Arabia
Netherlands
Ireland
United States
Germany
Italy
Brazil
Czechia
Israel
Spain
Turkey

location_facility: Hospital Clinico Universitario de Salamanca /ID# 224803

location_facility: Hospital Italiano de Buenos Aires /ID# 224153

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 225749

location_facility: Hadassah Medical Center-Hebrew University /ID# 224884

location_facility: Princess Noorah Oncology Center /ID# 224968

location_facility: Taichung Veterans General Hospital /ID# 227084

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Mar /ID# 227038

location_facility: Bagcilar Medipol Mega Universite Hastanesi /ID# 225515

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 228919

location_facility: ASST Grande Ospedale Metropolitano Niguarda /ID# 224608

location_facility: Hospital de Clinicas de Porto Alegre /ID# 224274

location_facility: Hospital Clinic de Barcelona /ID# 224804

location_facility: Hospital Universitario 12 de Octubre /ID# 225617

location_facility: CHU Reims - Hôpital Robert Debre /ID# 231131

location_facility: Instituto COI de Educacao e Pesquisa /ID# 224245

location_facility: Hospital Israelita Albert Einstein/Farmacia da Oncologia /ID# 224303

location_facility: Fakultni nemocnice Hradec Kralove /ID# 224089

location_facility: University of Texas Southwestern Medical Center /ID# 223865

location_facility: Hospital Universitario Germans Trias i Pujol /ID# 229281

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 229524

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 223702

location_facility: Klinicki bolnicki centar Zagreb /ID# 226969

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 224690

location_facility: Beneficencia Portuguesa de Sao Paulo /ID# 224305

location_facility: Maastricht Universitair Medisch Centrum /ID# 224694

location_facility: Instytut Hematologii i Transfuzjologii /ID# 227039

location_facility: Tel Aviv Sourasky Medical Center /ID# 224883

lead_sponsor_type: industriel

status_simplified: Ongoing


type: EudraCT Number

title: A Phase I/II Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Subjects With Relapsed or Refractory Multiple Myeloma

summary:
The phase 1 primary objectives of this study are to assess the safety profile, characterize pharmacokinetics (PK) and determine the dosing schedule, maximum tolerated dose (MTD), and recommended phase 2 dose (RPTD) of ABT-199 (venetoclax) when administered in participants with relapsed or refractory multiple myeloma. This study will also assess the safety profile and PK of venetoclax in combination with dexamethasone in participants with t(11;14)-positive multiple myeloma.

The phase 2 primary objective is to further evaluate the objective response rate (ORR) and very good partial response or better rate (VGPR+) in participants with t(11;14)-positive multiple myeloma.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Kumar S, Kaufman JL, Gasparetto C, Mikhael J, Vij R, Pegourie B, Benboubker L, Facon T, Amiot M, Moreau P, Punnoose EA, Alzate S, Dunbar M, Xu T, Agarwal SK, Enschede SH, Leverson JD, Ross JA, Maciag PC, Verdugo M, Touzeau C. Efficacy of venetoclax as targeted therapy for relapsed/refractory t(11;14) multiple myeloma. Blood. 2017 Nov 30;130(22):2401-2409. doi: 10.1182/blood-2017-06-788786. Epub 2017 Oct 10.

family: Kumar

full_name: Shaji Kumar

given: Shaji

sequence: first

name: Winship Cancer Institute of Emory University, Atlanta, GA;

family: Kaufman

full_name: Jonathan L. Kaufman

given: Jonathan L.

sequence: additional

name: Hematologic Malignancies & Cellular Therapy, Duke University, Durham, NC;

family: Gasparetto

full_name: Cristina Gasparetto

given: Cristina

family: Mikhael

full_name: Joseph Mikhael

given: Joseph

name: Washington University School of Medicine, St. Louis, MO;

family: Vij

full_name: Ravi Vij

given: Ravi

name: Centre Hospitalier Universitaire, Grenoble, France;

family: Pegourie

full_name: Brigitte Pegourie

given: Brigitte

name: Centre Hospitalier Regional Universitaire, Tours, France;

family: Benboubker

full_name: Lofti Benboubker

given: Lofti

name: Centre Hospitalier Regional Universitaire Lille, Hopital Huriez, Lille, France;

family: Facon

full_name: Thierry Facon

given: Thierry

name: Centre Hospitalier Universitaire de Nantes, INSERM, Université de Nantes, France;

family: Amiot

full_name: Martine Amiot

given: Martine

family: Moreau

full_name: Philippe Moreau

given: Philippe

name: Genentech Inc., South San Francisco, CA; and

family: Punnoose

full_name: Elizabeth A. Punnoose

given: Elizabeth A.

family: Alzate

full_name: Stefanie Alzate

given: Stefanie

family: Dunbar

full_name: Martin Dunbar

given: Martin

full_name: Tu Xu

given: Tu

family: Agarwal

full_name: Suresh K. Agarwal

given: Suresh K.

family: Enschede

full_name: Sari Heitner Enschede

given: Sari Heitner

family: Leverson

full_name: Joel D. Leverson

given: Joel D.

family: Ross

full_name: Jeremy A. Ross

given: Jeremy A.

family: Maciag

full_name: Paulo C. Maciag

given: Paulo C.

family: Verdugo

full_name: Maria Verdugo

given: Maria

family: Touzeau

full_name: Cyrille Touzeau

given: Cyrille

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Blood

oa_host_type: publisher

evidence: open (via free article)

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

location_facility: Medical College of Wisconsin /ID# 205229

location_facility: Duplicate_University Hospital Leuven /ID# 170715

location_facility: Washington University-School of Medicine /ID# 76094

location_facility: Swedish Cancer Institute - Edmonds /ID# 170006

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 74995

location_facility: University of Nebraska Medical Center /ID# 169158

location_facility: Duplicate_CHU Grenoble - Hopital Michallon /ID# 126658

location_facility: CHRU Tours - Hopital Bretonneau /ID# 126639

location_facility: University of Arkansas for Medical Sciences /ID# 170002

location_facility: Emory University, Winship Cancer Institute /ID# 74993

location_facility: University Hospitals - Seidman Cancer Center /ID# 204502

location_facility: Baylor University Medical Ctr. /ID# 170056

location_facility: Univ of Wisconsin Hosp/Clinics /ID# 200246

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 75033

location_facility: University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 170007


title: FIGHT: A Phase 2 Randomized, Double-Blind, Controlled Study Evaluating Bemarituzumab (FPA144) and Modified FOLFOX6 in Patients With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer: Phase 2 Preceded by Dose-Finding in Phase 1

acronym: FIGHT

summary: This is a global, randomized, double-blind, controlled study to evaluate the efficacy of bemarituzumab (FPA144) + mFOLFOX6 versus placebo + mFOLFOX6 in patients with FGFR2 selected Gastric Cancer (as determined by prospective IHC FGFR2b overexpression and/or a ctDNA blood assay demonstrating FGFR2 gene amplification)

status: Active, not recruiting

design_allocation: Randomized

ReferenceCitation: Xiang H, Liu L, Gao Y, Ahene A, Macal M, Hsu AW, Dreiling L, Collins H. Population pharmacokinetic analysis of phase 1 bemarituzumab data to support phase 2 gastroesophageal adenocarcinoma FIGHT trial. Cancer Chemother Pharmacol. 2020 Nov;86(5):595-606. doi: 10.1007/s00280-020-04139-4. Epub 2020 Sep 23.

family: Xiang

full_name: Hong Xiang

given: Hong

family: Liu

full_name: Lucy Liu

given: Lucy

family: Gao

full_name: Yuying Gao

given: Yuying

family: Ahene

full_name: Ago Ahene

given: Ago

family: Macal

full_name: Monica Macal

given: Monica

family: Hsu

full_name: Amy W. Hsu

given: Amy W.

family: Dreiling

full_name: Lyndah Dreiling

given: Lyndah

family: Collins

full_name: Helen Collins

given: Helen

journal_name: Cancer Chemotherapy and Pharmacology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ipd_sharing: No

lead_sponsor: Five Prime Therapeutics, Inc.

location_country:
Italy
Spain
Germany
France
Japan
Poland
Thailand
Romania
Hungary
Belgium
Australia
China
Turkey
United States
United Kingdom
Korea, Republic of
Taiwan
Portugal

location_facility: Hopital Nord France Comte - Site Le Mittan

location_facility: Hyogo College of Medicine College Hospital

location_facility: Utah Cancer Specialists (Intermountain Hematology - Oncology Associates) UCS Cancer Center

location_facility: Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

location_facility: Universitatsmedizin Manheim, II. Medizinische Klinik

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

location_facility: Northwestern Medicine Cancer Center Warrenville

location_facility: Institut Catala d'Oncologia - Hospital Doctor Josep Trueta

location_facility: Harbin Medical University Cancer Hopsital

location_facility: UCLA Medical Centre - Santa Monica Hematology and Oncology

location_facility: Cukurova University Faculty of Medicine Paediatric Nephrology

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Fourth Hospital of Hebei Medical University

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: SP ZOZ Ministerstwa Spraw Wewnetrznych z Warminsko - Mazurskim Centrum Onkologii

location_facility: Institutul Clinic Fundeni - Clinica Pediatrie

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: Marin Cancer Care, Inc-California Cancer Care A Medical Group, Inc

location_facility: Gaziantep Universitesi Tip Fakultesi, Sahinbey Onkoloji Hastanesi

location_facility: Hospital Universitario Mutua de Terrassa

location_facility: A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette

location_facility: Lekarz Beata Madej Mruk I Partner. Spolka Partnerska Oddzial nr 1 w Rzesowie

location_facility: Del-Pesti Centrumkorhaz - Orszangos Hematologiai es Infektologiai Intezet, Onkologiai Osztaly

location_facility: The Second Affiliated Hospital of Soochow University

location_facility: Chungnam National University Hospital (CNUH)

location_facility: ASST della Valtellina e dell'Alto Lario - PO di Sondrio

location_facility: Azienda Socio-Sanitaria Territoriale di Cremona

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: Josephine Ford Cancer Center-Henry Ford Cancer Center

location_facility: Institutul Oncologic, Prof. Dr. I. Chiricuta Cluj-Napoca

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im. F. Chopina

location_facility: Westchester Institute For Treatment Of Cancer & Blood Disorders

location_facility: Sino Japanese Friendship Hospital of Jilin University

location_facility: University of Pecs, Clinic of Oncotherapy

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie

location_facility: Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny Ministerstwa Obronty Narodowej

location_facility: Cancer Hospital of Shantou University Medical College

location_facility: University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center)

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Istanbul Madeniyet Universitesi Tip Fakultesi

location_facility: Hospital Duran I Reynals - Instituto Catalan de Oncologia

location_facility: Krankenhaus Nordwest gGmbH, Institut fur Klinisch-Onkologische Forschung

location_facility: Adnan Menderes Universitesi Uygulama ve Arastirma Hastanesi

location_facility: Centro Hospitalar de Entre o Douro e Vouga EPE

location_facility: Ruijin Hospital Affiliated to Shanghai Jiatong University School of Medicine

location_facility: Fondazione IRCSS Casa Sollievo Della Sofferenza

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

location_facility: Ankara Oncology Education and Research Hospital

location_facility: Servizio Oncologia Medica ed Ematologia, AOU dell'Universita

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

location_facility: Seoul National University Bundang Hospital

location_facility: Ondokuz Mayis University Medicine Faculty

location_facility: Instituto Portugues de Oncologia do Porto Francisco Gentil E.P.E

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Szpital Specjalistyczny w Brzozowie, Podkarpacki Osrodek Onkologiczny

location_facility: Inonu Universitesi Tip Fakultesi Turgut Ozal Tip Merkezi

location_facility: Summit Medical Group. Morristown Oncology

location_facility: Faculty of Medicine, Prince of Sonkla University

location_facility: Klinikum Ostalb, Stauferklinikum Schwabisch Gmund, Zentrum fur Innere Medizin

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico - IRCCS di Candiolo

location_facility: Azienda Ospedaliero Universitaria Caregg - I S.O.D. Oncologia Medica

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Unidade Local de Saude de Matosinhos EPE

location_facility: Centro Hospitalar Universitario do Porto E.P.E

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Spitalul Clinic Judetean de Urgenta ,,Sf. Apostol Andrei" Constanta, Clinica Oncologie Medicala

location_facility: Kliniken Nordoberpfalz AG, Klinikum Weiden, Medizinische Klinik I

location_facility: Xiangya Hospital of Central South University

location_facility: Sugarterapias es Klinikai Onkologaiai Intezet B-A-Z Megyei Korhaz

location_facility: Hartford Healthcare Cancer Institute at The Hospital of Central Connecticut

location_facility: Faculty of Medicine, Chulalongkorn University

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: Azienda Sanitaria Universitaria Integrata de Udine

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie Klinika Onkologi I Radioterapii

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Japan Community Health Care Organization Kyushu Hospital

location_facility: St. Luke's Physician Group - St. Luke's Cancer Care Associates

location_facility: Policlinico Universitario Campus Bio-Medico di Roma

location_facility: Beskidzkie Centrum Onkologii - Szpital Miejski im. Jana Pawla II w Bielsku-Bialej

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendelointezet

location_facility: Ospedale Generale Mater Salutis" - Azienda ULSS n. 21 di Legnago

location_facility: Innovative Clinical Research Institute (ICRI)

location_facility: S.C. Centrul de Oncologie Sf. Nectarie S.R.L., Oncologie Medicala

location_facility: Centre de Radiotherapie - Clinique Sainte Anne

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

location_facility: Klinik fur Innere Medizin, Shwerpunkt Gastroenterologie, Hamatologie, Onkologie, Nephrologie

intervention_type: Drug


title: Status Epilepticus in the Critically Ill Patients

summary:
Convulsive and Non Convulsive Status Epilepticus (SE) and Pseudo Status Epilepticus prospective registry.

Data collection using a standardized form : demographic data and data related to the SE, including circumstances of onset, dates and times of onset and of seizure control, on-scene clinical findings, clinical features of the seizures, pre-hospital and hospital care providers, timing of antiepileptic and supportive treatments, results of etiological investigations, cause of SE, type and dosage of antiepileptic drugs. Dates and times of EEG monitoring, EEG results. Outcomes including vital status and Glasgow Outcome Scale score at ICU and hospital discharge, day-90 and 1-year after SE and determined based on data in the ICU and/or neurologist charts and/or patients phone interview.

lead_sponsor: Ictal Group

location_facility: CH de Bethune - Service de Réanimation et Surveillance continue

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Groupe Hospitalier Sud Ile de France - Service de Réanimation - Médecin intensive

location_facility: Hôpital privé Jacques Cartier - Service de réanimation médico chirurgicale

location_facility: Centre Hospitalier Universitaire Régional

location_facility: Centre hospitalier de Roanne - Service de Réanimation - Soins continus

location_facility: CH de La Rochelle - Service de réanimation - USC

location_facility: CH de Beauvais - Service de réanimation polyvalente

location_facility: Groupe Hospitalier Paris Saint Joseph - Service de réanimation médico chirurgicale

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: CH Angouleme - Service de réanimation polyvalente

location_facility: CH Brive La Gaillarde - Service de réanimation - USC

location_facility: Intensive Care Unit - Versailles Hospital

location_facility: CH Public du Cotentin - Service de Réanimation - Médecin intensive

location_facility: Hopitaux Universitaires Henri Mondor - Service d'anesthésie et des réanimations chirurgicales, Unité d'anesthésie-réanimation chirurgical cardiovasculaire

location_facility: HP Claude Galien - Service de Réanimation Polyvalente


type: U.S. NIH Grant/Contract

type: Registry Identifier

title: A Randomized, Open-Label, Phase III, International Study of Subcutaneous Recombinant IL-2 in Patients With HIV-1 Infection and CD4+ Cell Counts 300/mm^3 or Greater: Evaluation of Subcutaneous Proleukin in a Randomized International Trial

acronym: ESPRIT

summary:
The purpose of this study is to see if it is effective to give HIV positive patients recombinant interleukin-2 (rIL-2) in addition to anti-HIV therapy. Patients will be followed over a minimum of 4 years to study the long-term effects of rIL-2 on their HIV disease progression.

Anti-HIV therapy has been very successful in treating HIV positive patients and in keeping viral load (level of HIV in the blood) low. However, anti-HIV drugs cannot completely rid the body of the virus, and the immune system is never completely restored in HIV positive patients. Doctors hope that giving patients recombinant interleukin-2 (rIL-2) in addition to their anti-HIV therapy will help improve their immune systems and keep them healthier over a longer period of time. rIL-2 is a hormone naturally produced by the body during an immune response to a microbial infection.

ReferenceType: background

ReferenceCitation: Chun TW, Engel D, Mizell SB, Hallahan CW, Fischette M, Park S, Davey RT Jr, Dybul M, Kovacs JA, Metcalf JA, Mican JM, Berrey MM, Corey L, Lane HC, Fauci AS. Effect of interleukin-2 on the pool of latently infected, resting CD4+ T cells in HIV-1-infected patients receiving highly active anti-retroviral therapy. Nat Med. 1999 Jun;5(6):651-5.

ReferenceCitation: Connors M, Kovacs JA, Krevat S, Gea-Banacloche JC, Sneller MC, Flanigan M, Metcalf JA, Walker RE, Falloon J, Baseler M, Feuerstein I, Masur H, Lane HC. HIV infection induces changes in CD4+ T-cell phenotype and depletions within the CD4+ T-cell repertoire that are not immediately restored by antiviral or immune-based therapies. Nat Med. 1997 May;3(5):533-40.

ReferenceCitation: Emery S, Abrams DI, Cooper DA, Darbyshire JH, Lane HC, Lundgren JD, Neaton JD; ESPRIT Study Group. The evaluation of subcutaneous proleukin (interleukin-2) in a randomized international trial: rationale, design, and methods of ESPRIT. Control Clin Trials. 2002 Apr;23(2):198-220.

ReferenceType: result

ReferenceCitation: Arduino RC, Nannini EC, Rodriguez-Barradas M, Schrader S, Losso M, Ruxrungtham K, Allende MC, Emery S, Fosdick L, Neaton J, Tavel JA, Davey RT, Lane HC; Evaluation of Subcutaneous Proleukin in a Randomized International Trial (ESPRIT) Vanguard Group; ESPRIT Executive Committee. CD4 cell response to 3 doses of subcutaneous interleukin 2: meta-analysis of 3 Vanguard studies. Clin Infect Dis. 2004 Jul 1;39(1):115-22. Epub 2004 Jun 14.

ReferenceCitation: INSIGHT-ESPRIT Study Group; SILCAAT Scientific Committee, Abrams D, Lévy Y, Losso MH, Babiker A, Collins G, Cooper DA, Darbyshire J, Emery S, Fox L, Gordin F, Lane HC, Lundgren JD, Mitsuyasu R, Neaton JD, Phillips A, Routy JP, Tambussi G, Wentworth D. Interleukin-2 therapy in patients with HIV infection. N Engl J Med. 2009 Oct 15;361(16):1548-59. doi: 10.1056/NEJMoa0903175.

journal_name: New England Journal of Medicine

oa_host_type: repository

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

repository_institution: The University of Queensland - Queensland's institutional digital repository

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

repository_normalized: HAL

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

repository_institution: PubMed Central - Europe PMC

version: acceptedVersion

repository_institution: University of Sussex - Sussex Research Online

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

repositories_institution: University of Sussex - Sussex Research Online

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Interleukin-2 Therapy in Patients with HIV Infection

ReferenceCitation: Larson GS, Carey C, Grarup J, Hudson F, Sachi K, Vjecha MJ, Gordin F; INSIGHT Group. Lessons learned: Infrastructure development and financial management for large, publicly funded, international trials. Clin Trials. 2016 Apr;13(2):127-36. doi: 10.1177/1740774515625974. Epub 2016 Feb 8.

name: Coordinating Centers for Biometric Research, Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA

family: Larson

full_name: Gregg S Larson

given: Gregg S

name: The Kirby Institute, University of New South Wales, Sydney, NSW, Australia

family: Carey

full_name: Cate Carey

given: Cate

name: Copenhagen HIV Programme, University of Copenhagen, Copenhagen, Denmark

family: Grarup

full_name: Jesper Grarup

given: Jesper

family: Hudson

full_name: Fleur Hudson

given: Fleur

name: Sponsored Projects Administration, University of Minnesota, Minneapolis, MN, USA

family: Sachi

full_name: Karen Sachi

given: Karen

name: Veterans Affairs Medical Center, Washington, DC, USA

family: Vjecha

full_name: Michael J Vjecha

given: Michael J

family: Gordin

full_name: Fred Gordin

given: Fred

journal_name: Clinical Trials

ReferenceCitation: Nordell AD, McKenna M, Borges ÁH, Duprez D, Neuhaus J, Neaton JD; INSIGHT SMART, ESPRIT Study Groups; SILCAAT Scientific Committee. Severity of cardiovascular disease outcomes among patients with HIV is related to markers of inflammation and coagulation. J Am Heart Assoc. 2014 May 28;3(3):e000844. doi: 10.1161/JAHA.114.000844.

name: Department of Infectious Diseases, Rigshospitalet and Copenhagen HIV Programme, University of Copenhagen, Copenhagen, Denmark

name: Cardiovascular Division, University of Minnesota, Minneapolis, MN

name: the INSIGHT SMART, ESPRIT Study Groups, and SILCAAT Scientific Committee

journal_name: Journal of the American Heart Association

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

repository_institution: Griffith University, Queensland, Australia - Griffith Research Online

repository_institution: University of Copenhagen - Research at the University of Copenhagen

repositories_institution: Griffith University, Queensland, Australia - Griffith Research Online

repositories_institution: University of Copenhagen - Research at the University of Copenhagen

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Severity of Cardiovascular Disease Outcomes Among Patients With HIV Is Related to Markers of Inflammation and Coagulation

ReferenceCitation: Mocroft A, Neuhaus J, Peters L, Ryom L, Bickel M, Grint D, Koirala J, Szymczak A, Lundgren J, Ross MJ, Wyatt CM; INSIGHT SMART Study Group; ESPRIT Study Group. Hepatitis B and C co-infection are independent predictors of progressive kidney disease in HIV-positive, antiretroviral-treated adults. PLoS One. 2012;7(7):e40245. Epub 2012 Jul 20.

ReferenceCitation: Pett SL, Carey C, Lin E, Wentworth D, Lazovski J, Miró JM, Gordin F, Angus B, Rodriguez-Barradas M, Rubio R, Tambussi G, Cooper DA, Emery S; INSIGHT-ESPRIT Study Group. Predictors of bacterial pneumonia in Evaluation of Subcutaneous Interleukin-2 in a Randomized International Trial (ESPRIT). HIV Med. 2011 Apr;12(4):219-27. doi: 10.1111/j.1468-1293.2010.00875.x. Epub 2010 Aug 31.

lead_sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

location_country:
Australia
Belgium
Denmark
Morocco
France
Japan
Poland
Thailand
Norway
Argentina
Canada
Sweden
Switzerland
Netherlands
Singapore
Ireland
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Israel
Spain

location_facility: New Jersey Community Research Initiative, Jeffrey Bomser Clinic CRS

location_facility: Harlem Hospital Ctr./Columbia University CRS (Gordin CTU)

location_facility: John Hunter Hosp., Immunology & Infectious Diseases Unit CRS

location_facility: Univ. of Tokyo, Research Hosp. of the Institute of Medical Science CRS

location_facility: Univ. of Colorado Health Science Ctr. CRS

location_facility: Univ. College London Med. School, Ctr. for Sexual Health & HIV Research CRS

location_facility: Univ. of Wuerzburg, Medizinische Poliklinik, Schwerpunkt Hepatologie/Infektiologie CRS

location_facility: Klinik I fur Innere Medizin der Universitat zu Koln, Studienburo fur Infektiologie u. HIV CRS

location_facility: Szpital Specjalistyczny, Osrodek Diagnostyki i Terapii AIDS CRS

location_facility: Hospital Nacional Professor Alejandro Posadas CRS

location_facility: C.H.U. Bichat - Claude Bernard Service des Maladies Infectieuses et Tropicales CRS

location_facility: Univ. Clinical Research Ctr., Memorial Hermann Hosp. CRS

location_facility: St. Joseph's Health Ctr. of London, HIV Care Programme CRS

location_facility: Hosp. de Santa Maria, Servico de Doencas Infecciosas CRS

location_facility: Civili di Brescia, 1st Division of Infectious Diseases CRS

location_facility: Newcastle Gen. Hosp., Dept of Infection & Tropical Medicine CRS

location_facility: Hosp. 12 de Octubre, Pabellon de Medicina Communitaria CRS

location_facility: Lakeshore Infectious Disease Associates CRS

location_facility: Walter Reed Army Med. Ctr., Infectious Disease Clinic CRS

location_facility: McMaster Univ. Med. Ctr. Hamiton Health Sciences, SIS Clinic CRS

location_facility: Positive Health Practice West/ Dr. Steve Deeks CRS

location_facility: San Matteo Hospital - University of Pavia, Division of Infectious and Tropical Diseases CRS

location_facility: Royal Victoria Hosp. Dept. of Genitourinary Medicine CRS

location_facility: Multnomah County Health Dept., HIV Health Services Ctr. CRS

location_facility: Civili di Brescia, Dept of Infectious & Tropical Disease, Hosp.Spedali Civili of Brescia CRS

location_facility: Osaka National Hosp. AIDS Ctr., Clinical Research Institute CRS

location_facility: Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS

location_facility: Hosp. Gen. de Agudos Juan A. Fernandez CRS

location_facility: King's College Hosp., Caldecot Ctr. Dept. of Sexual Health CRS

location_facility: St. Thomas' Hosp., Dept. of GU Medicine CRS

location_facility: Cathedral Healthcare System, St. Michael's Med. Ctr. CRS

location_facility: Univ. of Alberta Hosp., Clinical Research Office CRS

location_facility: Hopital de Bicetre, Service de Medecine Interne CRS

location_facility: Hopital Gui de Chauliac, Service des Maladies Infectieuses et Tropicales CRS

location_facility: Chonburi Regional Hosp., Dept. of Internal Medicine CRS

location_facility: Hosp. Santa Creu i Sant Pau, Servicio de Medicina Interna CRS

location_facility: Hvidovre Univ. Hosp., Dept. of Infectious Diseases CRS

location_facility: William Beaumont Hosp., Infectious Disease Research CRS

location_facility: Kaiser Immune Deficiency Clinic of Portland CRS

location_facility: Hosp. Italiano de Buenos Aires, Infectious Diseases Section CRS

location_facility: Hopital de l'Archet 1, Service de Medecine Interne 2 Hematologie Clinique CRS

location_facility: Edith Cavell Hosp. Dept. of Sexual Health, Clinic E CRS

location_facility: Heartlands Hosp. Dept. of Infection & Tropical Disease Outpatients CRS

location_facility: Jacobi Med. Ctr., Ambulatory Care Pavillion CRS

location_facility: Infectious Disease Specialists of N.J., North Jersey Community Research Initiative CRS

location_facility: Aalborg Hosp., Dept. of Infectious Diseases CRS

location_facility: Rambam Med. Ctr., Immunology, Allergy & AIDS Institute, B. Rappaport Faculty of Medicine, Technion

location_facility: Univ. Hosp. Heidelberg, Dept. of Dermatology CRS

location_facility: Hosp. Universitari Germans Trias i Pujol, HIV Unit and Retrovirology Lab. CRS

location_facility: Skejby Sygehus, Department of Infectious Diseases Q (ambulatoriet) CRS

location_facility: St. George's Hosp. Clinical Infection UnitCRS

location_facility: Univ. of Milan, Ospedale Luigi Sacco, Institute of Infectious and Tropical Diseases CRS

location_facility: Pomeranian Academy of Medicine (PAM), Dept. of Infectious Diseases and Hepatology CRS

location_facility: St. Joseph's Hosp. & Med. Ctr. of New Jersey CRS

location_facility: The Research & Education Group-Portland CRS

location_facility: UCSF PHP, Gen. Internal Medicine Practice CRS

location_facility: Ctr. Hospitalier Universitaire, St Pierre, Div. of Infectious Diseases (PL5) CRS

location_facility: Hospital Interzonal de Agudos Oscar Alende, Sala de Infectologia CRS

location_facility: Hopital de la Conception, Service des Maladies Infectieuses CRS

location_facility: Royal Victoria Hosp., Montreal Chest Institute CRS

location_facility: Oregon Health & Sciences Univ. Internal Medicine (L-475) CRS

location_facility: Western Gen. Hosp., Regional Infectious Diseases Unit CRS

location_facility: Hosp. Gen. de Agudos JM Ramos Mejia, Servicio de Inmunocomprometidos CRS

location_facility: Ctr. for HIV & Hepatogastroenterology, HIV Specialised Practice (Private Practice) CRS

location_facility: Q.E. II Health Sciences Ctr., Captial District Authority, Victoria Gen. Hosp. CRS

location_facility: Med. Ctr. of Louisiana at New Orleans, HIV Outpatient Clinics CRS

location_facility: Tulane University Health Sciences Center, Louisiana Community AIDS Research Program(LaCARP) CRS

location_facility: Hopital Saint-Jacques, Service des Maladies Infectieuses et Tropicales CRS

location_facility: Leicester Royal Infirmary, Dept. of Infection & Tropical Medicine CRS

location_facility: Kaplan Med. Ctr., Ben Ari Institute of Clinical Immunology CRS

location_facility: Denver Infectious Diseases Consultants CRS

location_facility: Hopital Louis Mourier, Service de Medecine Interne CRS

location_facility: The Early Intervention Program at Kennedy Hosp. CRS

location_facility: Medizinische Universitaetsklinik - Bonn, Immunologische Ambulanz CRS

location_facility: Hopital Necker, Service des Maladies Infectieuses CRS

location_facility: Hopital Foch, Service de Medecine Interne CRS

location_facility: Univ. Hosp. Ctr. of the Med. School of Casablanca, Infectious Diseases Unit CRS

location_facility: Univ. of Miami, Infectious Diseases Clinical Research Unit CRS

location_facility: Tel Aviv Sourasky Med. Ctr., Clinical Immunology Unit and AIDS Ctr. CRS

location_facility: Hosp. Interzonal de Agudos San Juan de Dios CRS

location_facility: Univ. of Vienna Med. School, Div. of Allergy, Immunology & Infectious Diseases - Sued B CRS

location_facility: Universita La Sapienza, Clinica Universita La Sapienza CRS

location_facility: Hosp. de Clinicas Jose de San Martin, Div. Infectologia CRS

location_facility: Royal Hallamshire Hosp., Dept. of GU Medicine Communicable Diseases Unit CRS

location_facility: Hopital Tenon, Service de Maladies Infectieuses et Tropicales CRS

location_facility: Centre Hospitalier Universitaire de Quebec - CHUL, Centre de Recherche en Indectiologie CRS

location_facility: Hopital Saint-Antoine, Service de Maladies Infectieuses CRS

location_facility: Canberra Hosp., Canberra Sexual Health Clinic CRS

location_facility: Tan Tock Seng Hosp., Infectious Diseases Research Ctr. CRS

location_facility: St. John Hosp. & Med. Ctr., Infectious Diseases Dept. CRS

location_facility: South Texas Veterans Health Care System, Immunosuppression Clinic CRS

location_facility: Ospedale S. Maria Annunziata, U.O. Malattie Infettive CRS

location_facility: Centro de Referencia e Treinamento em DST/AIDS - Sao Paulo CRS

location_facility: Regional Hosp. of Lugano (Sede Civico), Ospedale Civico di Lugano, Infectious Diseases Unit CRS

location_facility: Toronto Gen. Hosp. Infectious Diseases CRS

location_facility: The Alfred Hosp., Clinical Research - Infectious Diseases Unit CRS

location_facility: Hopital Avicenne, Service de Medecine B CRS

location_facility: San Francisco VAMC, Infectious Diseases Clinic CRS

location_facility: Ospedale San Raffaele, Centro San Luigi - Divisione Malattie Infettive CRS

location_facility: Hopital Raymond Poincare - Vidal 2, Service des Maladies Infectieuses et Tropicales CRS

location_facility: CHUS - Hopital Fleurimont, Centre de Recherche Clinique CRS

location_facility: St. Mary's Hosp. of London, Imperial College School of Medicine CRS

location_facility: VA Greater Los Angeles Healthcare System, Infectious Diseases Section CRS

location_facility: CHRU d'Angers, Service de Maladies Infectieuses CRS

location_facility: Univ. Hosp. Charite, Dept of Infectious Diseases CRS

location_facility: George Washington Univ. Med. Ctr. Infectious Diseases - Clinical Trials Unit CRS

location_facility: Centro de Investigacion Carlos III, Infectious Diseases Dept. CRS

location_facility: Legacy Community Health Services, Inc., Montrose Clinic, Inc.

location_facility: The HAVEN Program, Sudbury Regional Hosp., Laurentian Site CRS

location_facility: Windsor Regional Hosp., HIV Care Program CRS

location_facility: Groningen Univ. Hosp., Department of Internal Medicine CRS

location_facility: Karolinska Univ. Hosp. Huddinge, Dept. of Infectious Diseases CRS

location_facility: Hosp. Juan Canalejo, Dept. of Internal Medicine CRS

location_facility: Venhalsan, Soder Hosp., Dept. of Infectious Diseases, Karolinska Univ. Hosp. CRS

location_facility: SMZ Baumgartner Hoehe, Immunambulanz Pavillion Wienerwald Parterre CRS

location_facility: Hosp. del Mar, Internal Medicine-Infectious Diseases CRS

location_facility: Raritan Bay Med. Ctr., Perth Amboy Division CRS

location_facility: Rigshospitalet, Department of Infectious Diseases, M5112 CRS

location_facility: Royal London Hosp., Ambrose King Ctr. CRS

location_facility: Hosp. Gen. de Agudos 'Teodoro Alvarez' CRS

location_facility: Universidade Federal de Sao Paulo,IDIPA-Instituto Paulista de Doencas Infecciosas e Parasitarias CRS

location_facility: Hopital Europeen Georges Pompidou, Service d'Immunologie Clinique CRS

location_facility: Ulleval Hosp., Dept. of Infectious Diseases CRS

location_facility: Hopital Henri Mondor, Immunopathologie Clinique CRS

location_facility: Hosp. Severo Ochoa, Internal Medicine and Infectious Diseases CRS

location_facility: Instituto de Infectologia Emilio Ribas CRS

location_facility: Hosp. Virgen del Rocio, Infectious Diseases Service CRS

location_facility: Siriraj Hosp., Mahidol Univ. INSIGHT CRS

location_facility: Brighton & Sussex Univ. Hosp. NHS Trust, HIV Research Office CRS

location_facility: Hopital Cochin, Service de Medecine Interne 2 CRS

location_facility: Univ. of Illinois Family Ctr. for Infectious Disease CRS

location_facility: Royal Free Hosp., Dept. of Infection & Immunity, Ian Charleson Day Ctr. CRS

location_facility: Royal Melbourne Hosp., Victorian Infectious Diseases Service CRS

location_facility: Cairns Base Hosp., Sexual Health Services CRS

location_facility: Hosp. Universitario Gregorio Maranion, Microbiology & Infectious Diseases Unit CRS

location_facility: National Naval Med. Ctr., Infectious Diseases Special Immunology Clinic CRS

location_facility: Khon Kaen Univ., Srinagarind Hosp., Div. of Infectious Diseases & Tropical Medicine, Dept. of Medici

location_facility: OLVG -- locatie Prinsengracht, Dept. of Internal Medicine II CRS

location_facility: Virginia Commonwealth Univ. Medical Ctr. CRS

location_facility: Wroclaw Univ., School of Med., Dept. of Infectious Diseases, Liver Diseases and AIDS CRS

location_facility: Chulalongkorn Univ. Hosp., HIV-NAT Research Collaboration CRS

location_facility: Hospital de Cascais, HDDI, Departamento Medicina Interna CRS

location_facility: Providence Portland Med. Ctr., Ambulatory Care and Education Ctr. CRS

location_facility: Chelsea & Westminster Hosp., St. Stephens Ctr. CRS

location_facility: Hopital Maisonneuve-Rosemont, Dept. de Microbiologie CRS

location_facility: Universita degli Studi di Modena e Reggio Emilia, Clinica delle Malattie Infettive e Tropicali CRS

location_facility: Klinikum Innenstadt, Infektionsambulanz und Tagesklinik CRS

location_facility: Northwestern Memorial Physicians Group CRS

location_facility: Hosp. la Princesa, Internal Medicine and Infectious Diseases Service CRS

location_facility: Ruhr-Univ., Interdiszipl. Immunolog. Ambulanz CRS

location_facility: Hosp. Universitario Morales Meseguer CRS

location_facility: Positive Health Program Clinic (San Francisco Gen. Hosp.) CRS

location_facility: Hosp. Universitario Principe de Asturias CRS

location_facility: Abbott Northwestern Hosp., Clinic 42 CRS

location_facility: Hanover Med. Park (Mechanicsville, VA) CRS

location_facility: Royal Devon & Exeter NHS Foundation Trust, Heavitree Hosp., Dept. of GU Medicine CRS

location_facility: Hopital Antoine Beclere Service d'Immunologie Clinique CRS

location_facility: Stichting Medisch Centrum Jan van Goyen, Dept. of Internal Medicine CRS

location_facility: Centre Hospitalier de la Region Annecienne, Service des Maladie Infectieuses CRS

location_facility: Hopital Sainte Marguerite, CISIH Hopital de Jour CRS

location_facility: Hopital de La Salpetriere, Service de Medecine Interne CRS

location_facility: St. Bartholomew's Hosp., Infection & Immunity Clinical Group CRS

location_facility: Hosp. de Egas Moniz, Servicio de Infecciologia e Medicina Tropical CRS

location_facility: Johann Wolfgang Goethe Univ. Hosp., Infektionsambulanz CRS


type: Other Identifier

title: A Prospective, Multinational Study of Real-life Current Standards of Care in Patients With Relapsed and/or Refractory Multiple Myeloma Who Received at Least 3 Prior Lines of Therapy Including PI, IMID, and CD38 Monoclonal Antibody Treatment

acronym: LocoMMotion

summary: The purpose of this study is to assess the safety and clinical response including overall response rate (ORR) of real-life standard-of-care (SOC) treatments under routine clinical practice, over a 24-month period, in patients with relapsed/refractory multiple myeloma (RRMM).

lead_sponsor: Janssen-Cilag Ltd.

location_country:
Italy
United States
Netherlands
France
Poland
Belgium
Russian Federation
Spain
Germany
United Kingdom

location_facility: A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette

location_facility: Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik

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

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: Universita degli Studi di Padova - Azienda Ospedaliera di Pa

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

location_facility: Washington University School of Medicine

location_facility: U.O. Ematologia Istituto Tumori Giovanni Paolo II

location_facility: U.O. Ematologia con Trapianto- AOU Policlinico di Bari

location_facility: Grand Hôpital de Charleroi, site Notre Dame

location_facility: Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi

location_facility: Azienda Ospedaliera Universitaria Careggi

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

location_facility: Klinikum der Eberhard-Karls-Universität/Abt. für innere Med. II/Hämatologie/Onkologie-Germany

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego

location_facility: The Cancer Institute at St. Francis Hospital

location_facility: Fondazione Policlinico Universitario A. Gemelli IRCCS

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Oncology Hematology Assoc of Central Illinois, P.C. d.b.a. Illinois CancerCare, P.C.

location_facility: Oncology Institute of Hope and Innovation

location_facility: IRCCS Azienda Ospedaliera San Martino - IST

location_facility: S.P. Botkin Moscow City Clinical Hospital

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Nizhniy Novgorod Region Clinical Hospital

location_facility: North Shore Hematology Oncology Associates, P.C.

location_facility: Clinical Research Institute of Hematology and Transfusiology

intervention_type: Other


title: A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma

summary: The purpose of this study is to compare the efficacy of teclistamab-daratumumab (Tec-Dara) with daratumumab subcutaneously (SC) in combination with pomalidomide and dexamethasone (DPd) or daratumumab SC in combination with bortezomib and dexamethasone (DVd).

ipd_sharing: Yes

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

lead_sponsor: Janssen Research & Development, LLC

location_country:
Italy
United States
Brazil
Sweden
Netherlands
Spain
Germany
France
Greece
Belgium
Argentina
Russian Federation
China
Denmark
Canada
United Kingdom
Korea, Republic of
Taiwan
Ukraine

location_facility: Instituto COI de Pesquisa, Educacao e Gestao

location_facility: State Institution 'National Scientific Center for Radiation Medicine of NAMS of Ukraine'

location_facility: University of Athens - Evaggelismos Hospital (Evangelismos Hospital)

location_facility: Municipal Enterprise 'Poltava Reg. Clinical Hospital N.A. Sklifosovsky of The Poltava Reg. Council'

location_facility: U.O. Ematologia con Trapianto- AOU Policlinico di Bari

location_facility: St.-Petersburg City Clinical Hospital nr 31

location_facility: Anticancer Hospital of Thessaloniki 'Theageneio'

location_facility: First affiliated Hospital of Zhejiang University

location_facility: Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'

location_facility: Federal Center of Heart, Blood and Endocrinology

location_facility: A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette

location_facility: Sint Antonius Ziekenhuis - Afd.Interne - INT

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Chonnam National University Hwasun Hospital

location_facility: Blackpool Teaching Hospitals NHS Foundation Trust

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Saint-Petersburg State Pavlov University

location_facility: Institut de Cancérologie Strasbourg Europe (ICANS)

location_facility: University of Wisconsin Carbone Cancer Center

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

location_facility: Hospital Privado - Centro Medico de Cordoba

location_facility: National Cancer Institute, Dept. of chemotherapy of hemoblastosis

location_facility: Princess Margaret Cancer Centre University Health Network

location_facility: Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,

location_facility: Università di Roma 'La Sapienza' - Ospedale Umberto 1°

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

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel

location_facility: Institute of Blood Pathology and Transfusion Medicine of AMS of Ukraine

location_facility: University of Texas Southwestern Medical Center


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

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

location_facility: Narodowy Instytut Onkologii im.Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz. w Gliwicach

location_facility: Klinikum der Eberhard-Karls-Universität/Abt. für innere Med. II/Hämatologie/Onkologie-Germany

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego

location_facility: Karolinska Universitetssjukhuset Huddinge, Hematologiska Kliniken, Huddinge

location_facility: Attikon University General Hospital of Attica

location_facility: A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Institut Universitaire du cancer de Toulouse-Oncopole

location_facility: Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna

location_facility: Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

location_facility: Universitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden

location_facility: Washington University School of Medicine

location_facility: University Hospital Kyoto Perfectural University of Medicine

location_facility: Ospedale San Raffaele HSR Istituto Scientifico Universitario San Raffaele

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: University of Miami Leonard M. Miller School of Medicine - Sylvester Comprehensive Cancer Center

source: euctr

title: A Phase 3 Randomized Study Comparing JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA, Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects With Relapsed and Lenalidomide-Refractory Multiple Myeloma

summary: The purpose of this study is to compare the efficacy of JNJ-68284528 (ciltacabtagene autoleucel [cilta-cel]) with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd).


title: A Phase IIIb, Randomized, Open-label Study of the Safety and Efficacy of GSK1349572 (Dolutegravir, DTG) 50 mg Once Daily Compared to Darunavir/Ritonavir (DRV/r) 800 mg/100 mg Once Daily Each Administered With Fixed-dose Dual Nucleoside Reverse Transcriptase Inhibitor Therapy Over 96 Weeks in HIV-1 Infected Antiretroviral naïve Adult Subjects

acronym: FLAMINGO

summary: This study will be conducted in approximately 468 HIV-1 infected antiretroviral therapy (ART)-naïve subjects. Subjects will be randomized 1:1 to receive dolutegravir (DTG) 50 mg once daily (approximately 234 subjects) or darunavir/ritonavir (DRV/r) 800 mg/100 mg once daily (approximately 234 subjects), each in combination with fixed-dose dual nucleoside reverse transriptase inhibitor (NRTI) therapy (either abacavir/lamivudine (ABC/3TC) or tenofovir/emtricitabine (TDF/FTC). Subjects will be stratified by screening HIV-1 RNA and background NRTI selection. The primary analysis will take place after the last subject completes 48 weeks on therapy; an additional analysis will be conducted after the last subject completes Week 96 on study.

ReferenceCitation: Molina JM, Clotet B, van Lunzen J, Lazzarin A, Cavassini M, Henry K, Kulagin V, Givens N, de Oliveira CF, Brennan C; FLAMINGO study team. Once-daily dolutegravir versus darunavir plus ritonavir for treatment-naive adults with HIV-1 infection (FLAMINGO): 96 week results from a randomised, open-label, phase 3b study. Lancet HIV. 2015 Apr;2(4):e127-36. doi: 10.1016/S2352-3018(15)00027-2. Epub 2015 Mar 10. Erratum in: Lancet HIV. 2015 Apr;2(4):e126.

family: Molina

full_name: Jean-Michel Molina

given: Jean-Michel

family: Clotet

full_name: Bonaventura Clotet

given: Bonaventura

family: van Lunzen

full_name: Jan van Lunzen

given: Jan

family: Lazzarin

full_name: Adriano Lazzarin

given: Adriano

family: Cavassini

full_name: Matthias Cavassini

given: Matthias

family: Henry

full_name: Keith Henry

given: Keith

family: Kulagin

full_name: Valeriv Kulagin

given: Valeriv

family: Givens

full_name: Naomi Givens

given: Naomi

family: de Oliveira

full_name: Carlos Fernando de Oliveira

given: Carlos Fernando

family: Brennan

full_name: Clare Brennan

given: Clare

journal_name: The Lancet HIV

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Clotet B, Feinberg J, van Lunzen J, Khuong-Josses MA, Antinori A, Dumitru I, Pokrovskiy V, Fehr J, Ortiz R, Saag M, Harris J, Brennan C, Fujiwara T, Min S; ING114915 Study Team. Once-daily dolutegravir versus darunavir plus ritonavir in antiretroviral-naive adults with HIV-1 infection (FLAMINGO): 48 week results from the randomised open-label phase 3b study. Lancet. 2014 Jun 28;383(9936):2222-31. doi: 10.1016/S0140-6736(14)60084-2. Epub 2014 Apr 1. Erratum in: Lancet. 2015 Jun 27;385(9987):2576.

family: Feinberg

full_name: Judith Feinberg

given: Judith

family: Khuong-Josses

full_name: Marie-Aude Khuong-Josses

given: Marie-Aude

family: Antinori

full_name: Andrea Antinori

given: Andrea

family: Dumitru

full_name: Irina Dumitru

given: Irina

family: Pokrovskiy

full_name: Vadim Pokrovskiy

given: Vadim

family: Fehr

full_name: Jan Fehr

family: Ortiz

full_name: Roberto Ortiz

given: Roberto

family: Saag

full_name: Michael Saag

given: Michael

family: Harris

location_country:
Italy
United States
Switzerland
France
Romania
Puerto Rico
Russian Federation
Spain
Germany


title: Outcomes in Patients With Acute Encephalopathy and SARS-Cov-2 Infection

summary:
Infection with SARS-CoV-2 or severe acute respiratory syndrome coronarvirus type 2 was highlighted in December 2019 in the city of Wuhan in China, responsible for an pandemic evolution since March 11, 2020. The infection affects all ages of life, although affecting children in a very small proportion of cases. The typical presentation of the disease combines fever (98%), cough (76%), myalgia and asthenia (18%) as well as leukopenia (25%) and lymphopenia (63%). Upper airway involvement rare.

The main clinical presentation requiring hospitalization of infected patients is that of atypical pneumonia which may require critical care management (27%), and progress to an acute respiratory distress syndrome (67%) involving life-threatening conditions in almost 25% of patients diagnosed with SARS-CoV-2 infection. Other organ damage have been reported, mainly concerning kidney damage (29%) which may require renal replacement therapy in approximately 17% of patients.

Neurological damage has been very rarely studied, yet reported in 36% of cases in a study including patients of varying severity.

Finally, the mortality associated with this emerging virus is high in patients for whom critical care management is necessary, reported in 62% of patients.

We therefore propose a prospective observational study which aim at reporting the prevalence of acute encephalopathy at initial management in Critical/Intensive care or Neurocritical care , to report its morbidity and mortality and to identify prognostic factors.

location_country:
Brazil
Mexico
France
Egypt
Spain
United States
Colombia

location_facility: Grand Hôpital de l'Est Francilien - Site de Marne-la-Vallée

location_facility: Centre Hospitalier Universitaire Louis Mourier

location_facility: Jackson Memorial Health System; University of Miami, Miller School of Medicine

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Centre Hospitalier Universitaire Beaujon

location_facility: Centre Hospitalier Régional Universitaire de Brest

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Centre Hospitalier Universitaire de Tours

location_facility: Fundación Valle del Lili, University Hospital

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Hospital Regional De Alta Especialidad Del Bajío

location_facility: Centre Hospitalier Universitaire Hôpital Edouard Herriot

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Centre Hospitalier Universitaire Ambroise Paré


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:
Italy
Austria
Brazil
Peru
Mexico
Spain
France
Bulgaria
Greece
Poland
Romania
Hungary
Argentina
Russian Federation
Portugal
Turkey
United States
Canada
Colombia
Ukraine

acronym: Study of Romiplostim for CIT in in Adult Subjects with Gastrointestinal or Colorectal Cancer.

location_facility: Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej

location_facility: Mid Florida Hematology and Oncology Centers PA

location_facility: Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi

location_facility: Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

location_facility: CHRISTUS Highland Cancer Treatment Center

location_facility: State Institution of Public Health Oncology Dispensary 2 of Public Health Krasnodar Region

location_facility: Prof. Dr. Cemil Tascioglu Sehir Hastanesi

location_facility: Centro de Investigaciones Clínicas Clínica Viedma

location_facility: Fundacion Colombiana de Cancerologia Clinica Vida

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

location_facility: Colorado West Healthcare System dba Grand Valley Oncology

location_facility: Centro de Atencion e Investigacion Cardiovascular del Potosi Sc

location_facility: Oncology and Hematology Associates of West Broward, PA

location_facility: Omsk Regional Clinical Oncology Dispensary

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Hospital Universitario Madrid Sanchinarro

location_facility: Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi

location_facility: Szpital Kliniczny im Heliodora Swiecickiego Uniwersytetu Medycznego im Karola Marcinkowskiego w Pozn

location_facility: Leningrad Regional Oncology Dispensary na L D Roman

location_facility: SBHI of Arkhangelsk region Arkhangelsk clinical oncology dispensary

location_facility: Autonomic SHI Republican clinical oncology dispensary of MoH of the Republic of Tatarstan

location_facility: Universitaetsklinikum Allgemeines Krankenhaus Wien

location_facility: Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

location_facility: Clinical hospital 2, Group of companies medsi

location_facility: State budget institution of public health Pyatigorsk oncology dispensary

location_facility: General Oncology Hospital of Kifissia Agioi Anargyroi

location_facility: American Oncology Partners of Maryland, PA

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

location_facility: Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria

location_facility: Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi

location_facility: Grand River Regional Cancer Centre at Grand River Hospital

location_facility: Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano

location_facility: Hospital Clinico Universitario San Cecilio

location_facility: Spitalul Clinic al Cailor Ferate Cluj Napoca

location_facility: Massachusetts General Hospital Cancer Center

location_facility: Fundeni Clinical Institute for Digestive Disorders and Liver Transplantation

location_facility: FSBI Scientific and Research Oncology Institute named after N N Petrov

location_facility: Cape Breton Cancer Centre, Nova Scotia Health Authority

location_facility: Hospital Universitario Arnau de Vilanova Lleida

location_facility: University of California at Irvine Medical Center

location_facility: Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio

location_facility: The Center for Cancer and Blood Disorders

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

location_facility: Loema Instituto de Pesquisa Clinica & Consultores Ltda

location_facility: Specialized Hospital for Active Treatment of Oncology EAD

location_facility: Centro de Pesquisa da Serra Gaucha - Cepesg

location_facility: Kocaeli Universitesi Arastirma ve Uygulama Hastanesi

location_facility: State Institution of Public Health Tambov Regional Oncology Dispensary

location_facility: Transcarpathian Regional Clinical Oncological Dispensary

location_facility: Istanbul Universitesi Onkoloji Enstitusu

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: Powiatowe Centrum Zdrowia w Brzezinach Sp Z o o

location_facility: Hospital Universitario Fundacion Favaloro

location_facility: Centre Hospitalier Universitaire de Brest

location_facility: Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Szent Gyorgyi Albert Klinikai Kozpont

location_facility: Communal Institution Chernivtsi Regional Clinical Oncological Dispensary

title: RECITE: A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy- Induced Thrombocytopenia in Patients Receiving Oxaliplatin-based Chemotherapy for Treatment of Gastrointestinal, Pancreatic, or Colorectal Cancer

summary: Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects with Gastrointestinal, Pancreatic, or Colorectal Cancer


ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinicaltrials/ 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:
United States
Netherlands
Spain
France
Poland
Israel
Belgium
China
Germany
Korea, Republic of

location_facility: First Affiliated Hospital, SooChow University

location_facility: Severance Hospital, Yonsei University Health System

location_facility: University of Arkansas for Medical Sciences

location_facility: Washington University School of Medicine

location_facility: Narodowy Instytut Onkologii im.Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz. w Gliwicach

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

location_facility: Emory University - Winship Cancer Institute

location_facility: Klinikum Großhadern der Ludwig-Maximilians-Universität

location_facility: Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli

location_facility: CHU de Liège - Domaine Universitaire du Sart Tilman

location_facility: Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science

location_facility: First affiliated Hospital of Zhejiang University

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego

location_facility: The Ohio State University Wexner Medical Center - James Cancer Hospital

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

location_facility: Chonnam National University Hwasun Hospital

location_facility: First Affiliated Hospital of Xi'an Jiaotong University School of Medicine

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

location_facility: University of Texas, MD Anderson Cancer Center

title: A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma

summary: The purpose of this study is to evaluate the efficacy of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2Ds) (Part 3).


title: A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Teclistamab, a Humanized BCMA x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma

summary: The purpose of this study is evaluate the efficacy of teclistamab at the recommended Phase 2 dose (RP2D).

location_country:
Italy
United States
Sweden
Netherlands
Spain
Germany
France
Belgium
China
Canada
United Kingdom

location_facility: University Health Network (UHN) Princess Margaret Cancer Centre

location_facility: West China Hospital, Si Chuan University

location_facility: A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: University of Michigan Comprehensive Cancer Center

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

location_facility: Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi

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

location_facility: Winship Cancer Institute Emory University

location_facility: Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,

location_facility: University of Texas Southwestern Medical Center


title: WATCHMAN FLX Versus NOAC for Embolic ProtectION in in the Management of Patients With Non-Valvular Atrial Fibrillation

acronym: CHAMPION-AF

summary: The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation.

primary_purpose: Prevention

lead_sponsor: Boston Scientific Corporation

location_country:
Italy
United States
Switzerland
Netherlands
Germany
France
Japan
Poland
Belgium
Spain
Denmark
Canada
United Kingdom

location_facility: Memorial Hermann Memorial City Medical Center

location_facility: Memorial Health University Medical Center

location_facility: Institut universitaire de Cardiologie et de Pneumologie de Quebec

location_facility: Columbia University Medical Center/New York Presbyterian Hospital

location_facility: University of Iowa Hospitals and Clinics

location_facility: St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH

location_facility: University of Massachusetts Memorial Medical Center

location_facility: University Hospital of Lord's Transfiguration

location_facility: Novant Health Presbyterian Medical Center

location_facility: Sparrow Health System - Sparrow Hospital

location_facility: Christus Trinity Mother Frances Health System

location_facility: Providence Regional Medical Center Everett

intervention_type: Device


title: A Multicenter, Prospective, Observational, Non-Interventional Cohort Study Evaluating On-Treatment Predictors of Response in Subjects With HBeAg Positive and HBeAg Negative Chronic Hepatitis B Receiving Therapy With PEGASYS(R) (Peginterferon Alfa-2a 40KD)

summary: This observational, non-interventional cohort study will evaluate predictors of response in patients with chronic hepatitis B receiving standard of care Pegasys therapy. Efficacy and safety parameters will also be evaluated. Patients included in the study will be followed for the duration of their treatment and for up to 3 years thereafter.

lead_sponsor: Hoffmann-La Roche

location_country: Macedonia, The Former Yugoslav Republic of

location_facility: Universitätsklinikum S.-H. Campus Kiel Klinik für Innere Medizin I Gastroenterologie Hepotologie

location_facility: Specjalistyczny Szpital Wojewódzki im. Biegańskiego; Klinika Chorób Zakaźnych i Hepatologii UM

location_facility: Dow University of Health Sciences; Department of Medicine

location_facility: Klinikum rechts der Isar der TU München; II. Medizinische Klinik & Poliklinik

location_facility: Huashan Hospital Affiliated to Fudan University

location_facility: Universitätsklinikum Bonn Med. Klinik u. Poliklinik I

location_facility: Hopital Du Haut-Leveque; Gastro-Enterologie

location_facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck, Med. Klinik I, Transplantationszentrum

location_facility: Dr. Soetomo Hospital; Kidney and Hipertansion

location_facility: Hopital Purpan;Gastro Enterologie Hepatologie

location_facility: überörtl.Gem.Praxis Dres. Stephan Dupke Axel Baumgarten

location_facility: St. Georges Uni of London; Gastroenterology & Hepatology

location_facility: The Second Affiliated Hospital, Chongqing Medical University

location_facility: Campus Virchow-Klinikum Charité Centrum 13; Medizinische Klinik; Abt.Hepatologie u.Gastroenterologie

location_facility: Hopital De La Croix Rousse; Hepatologie Gastro Enterologie

location_facility: The 1st Affiliated Hospital of Harbin Medical University

location_facility: Hopital Jacques Monod; Gastro-Enterologie

location_facility: A.Ö. Krankenhaus Der Elisabethinen Linz; Iv. Med. Abtl.

location_facility: Infektionsmedizinisches Centrum Hamburg ICH Grindel

location_facility: Hospital For Infectious Diseases; Infectiology

location_facility: Manchester Royal Infirmary; Department Of Medicine

location_facility: Clinical Center Sarajevo; Gastroenterohepatology

location_facility: Universitätsklinikum Jena; Klinik für Innere Medizin II

location_facility: Hopital Saint Antoine; Hepatologie-Gastr-Enterologie

location_facility: Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.

location_facility: Hopital Hotel Dieu; Medecine Interne & D'Hepatologie

location_facility: Universitätsklinikum Klinik f. Gastroenterologie Hepatologie und Infektiologie

location_facility: Hopital Charles Nicolle; Gastro Enterologie

location_facility: Universitätsklinikum Münster Klinik und Poliklinik für Transplantationsmedizin

location_facility: Hopital De La Conception; Gastro Enterologie Endoscopie 2E Nord

location_facility: Hopital Jean Verdier; Gastro Enterologie

location_facility: Central Army Hospital Rspad Gatot Soebroto; Pulmonology

location_facility: King Fahad Medical City; Gastroentrology

location_facility: The First Affiliated Hospital of Wenzhou Medical College

location_facility: Cantonal Hospital Zenica; Department for Infective Diseases

location_facility: Yonsei Uni College of Medicine, Severance Hospital; Internal Medicine Dept.

location_facility: Hopital Trousseau; Gastro Enterologie A Et B

location_facility: Hopital Cote De Nacre; Gastro Enterologie

location_facility: Charité Universitätsmedizin Berlin; Campus Mitte, Centrum 12, Medizinische Poliklinik

location_facility: Cipto Mangunkusumo General Hospital; Hematology & Oncology

location_facility: Hotel-Dieu de France Hospital; Gastroenterology

location_facility: Hospital de Sao Joao; Servico de Gastrenterologia

location_facility: Medanta -The Medicity; Department of Digestive and Hepatobiliary Sciences

location_facility: Hull Royal Infirmary; Department Hepatology and Gastroenterology

location_facility: Spitalul Clinic de Boli Infectioase si Tropicale Dr. Victor; INFECTIOUS DISEASE

location_facility: Fondation Institut Arthur Vernes; Institut Arthur Vernes

location_facility: Hopital Robert Debre; Gastro Enterologie

location_facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

location_facility: NZOZ Lubuska Specjalistyczna Poradnia Chorob Watroby

location_facility: Ch Victor Dupouy; Hepato Gastro Medecine Interne

location_facility: Hopital Albert Michallon; Gastro Enterologie

location_facility: Clinical Center Banja Luka; Department for Infective Diseases

location_facility: Prince Hamzeh Hospital; Internal Medicine

location_facility: Holy Family Hospital; Department of Medicine

location_facility: Medical Uni of Bialystok; Infectious Diseases

location_facility: Clinical Infectious Diseases Hospital Victor Babes

location_facility: Sheikh Zayed Hospital; Department of Gastroentrology

location_facility: Wojewodzki Szpital; Specjalistyczny Chorob Zakaznych

location_facility: Medizinische Universitätsklinik; Med. Klinik Ii, Infektiologie

location_facility: St.Marien-Hospital Klinik Knappenstraße Klinik f.Gastroenterologie

location_facility: The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)

location_facility: Hopital Saint Andre; Hepato-Gastro-Enterologie

location_facility: Auckland Hospital; New Zealand Liver Transplant Unit

location_facility: Liver Clinic Lab-Aid Specialized Hospital

location_facility: University Clinical Center Tuzla; Clinic for Gastroenterology

location_facility: Hopital Hotel Dieu Et Hme; Hepatologie Gastro Enterologie

location_facility: The Eighth People's Hospital of Guangzhou

location_facility: CH Pitie Salpetriere; Hepathologie Gastro Enterologie

location_facility: MHAT Tokuda Hospital Sofia; Department of Gastroenterology at Clinic of Internal Deseases

location_facility: Universitätsklinikum Erlangen; Medizinische Klinik 1

location_facility: Nanjing No.2 Hospital; Liver Disease Department

location_facility: CAMPUS VIRCHOW-KLINIKUM; Charité Centrum 13; Med. Klinik Abt. Hepatologie u. Gastroenterologie

location_facility: Mater Misericordiae University Hospital;Gastrointestinal Unit/Center for Liver Disease

location_facility: Dres.Dietrich Hüppe Gisela Felten und Heinz Hartmann

location_facility: Yehia Elshazly Clinic for Hepatology and Gastroentrology

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II; Oddzial Wirusowego Zapalenia Watroby

location_facility: Salmaniya Medical Complex; Gastroenterology

location_facility: CHU Hassan 2; Service Gastro Enterologie Pr IBRAHIMI

location_facility: University Clinical Center Tuzla; Clinic for Infective Diseases

location_facility: Universitätsklinikum Magdeburg Klinik für Gastroenterologie und Hepatologie

location_facility: Dres. Andreas Schaffert Andreas Trein und Edith Ißler u.w.

location_facility: Tuen Mun Hospital; Medicine & Geriatrics

location_facility: Hasan Sadikin Hospital; Digestive Surgery

location_facility: Chiang Mai Uni Hospital; Faculty of Medicine

location_facility: Wilhelminenspital; Iv. Medizinische Abt.

location_facility: Hopital Antoine Beclere; Hepatologie Gastro Enterologie

location_facility: King Faisal Specialist Hospital & Research Centre; Oncology

location_facility: Ch Sud Francilien; Cons Gastro Enterologie

location_facility: The Hospital of Tropical and Infectious Disease Victor Babes

location_facility: Combined Military Hospital; Department of Medicine

location_facility: American University of Beirut - Medical Center

location_facility: Kyungpook National Uni Hospital; Internal Medicine

location_facility: Dr.med.Heiner W.Busch und Stefan Christensen

location_facility: Beijing 302 Hospital; No. 2 Infectious Disease Section

location_facility: Hopital Emile Muller; Gastro Enterologie

location_facility: Songklanagarind Hospital; Division of Gastroenterology

location_facility: Uni Heidelberg Med. Klinik; Innere Medizin IV

location_facility: The Third Hospital of Hebei Medical University

location_facility: Inst. of Infectious & Parasitic Diseases; Clinic of Hepatology & Aquired Immunodeficiencies

location_facility: Hopital Bichat Claude Bernard; Hepatologie Gastro Enterologie

location_facility: Institutul De Boli Infectioase Matei Bals; Sectia Clinica II Boli Infectioase Adulti

location_facility: Hopitaux de Brabois - Gastro-Entereologie

location_facility: Samsung Medical Centre; Division of Hematology/Oncology

location_facility: Clinical Center Skopje; Gastroenterohepatology

location_facility: King Fahad University Hospital; Internal Medicine

location_facility: Medical Uni of Lodz; Infectious Diseases

location_facility: Mhat Sveta Marina; Clinic of Gastroenterology

location_facility: Clinical Center Skopje; Infectious Diseases

location_facility: Centralny Szpital Kliniczny MSWiA; Oddzial Chorob Wewnetrznych i Hepatologii

location_facility: Klinikum Salzgitter-Lebenstedt Medizinische Klinik I

location_facility: Clinique De La Sauvegarde; Exploration Gastro Proctologie

location_facility: Hopital Paul Brousse; Centre Hepatologie Biliaire

location_facility: Universitätsklinikum Gießen und Marburg GmbH Standort Gießen Medizinische Klinik II

location_facility: Xinjiang Uygur Autonomous Region Hospital of Chinese Traditional Medicine

location_facility: Clinical Hospital Mostar; Department for Gastroenterology

location_facility: Hopital Henri Mondor; Hepatologie Gastro Enterologie

location_facility: Hospital Geral de Santo Antonio; Servico de Gastrenterologia

location_facility: Szpital Specjalistyczny; Oddzial Obserwacyjno - Zakayny

location_facility: Centre Hospitalier Universitaire Ibn Sina; Service de Gastro-entérologie Essaid

location_facility: Mitra International Jatinegara Hospital; Hepatology

location_facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Klinische Abt. Für Gaströnterologie & Hepatologie

location_facility: Hopital de Pontchaillou; Medicine Interne - Hepatologie

location_facility: Ch De Lagny Sur Marne; Gastro Enterologie

location_facility: Cantacuzino Clinical Hospital;Gastroenterology Department

location_facility: North West Armed Forces Hospital; Internal Medicine

location_facility: Charité - Campus Benjamin Franklin; Zentrum fuer Innere Medizin, Med. Klinik I

location_facility: Universitätsklinikum Freiburg Medizinische Klinik Innere Medizin I

location_facility: Pomorskie Centrum Chorob Zakaznych i Gruzlicy

location_facility: Hospital de Santa Maria; Servico de Gastrenterologia e Hepatologia

location_facility: Sree Gokulam Medical College and Research Foundation

location_facility: Universitaetsklinikum Essen, Innere Klinik und Poliklinik fuer Tumorforschung

location_facility: Bintaro International Hospital, Hepatology

location_facility: Wojewódzki specjalistyczny szpital im. Bieganskiego; Oddział Obserwacyjno-Zakazny i Chorob Watroby

location_facility: Hopital Nord; Reseau Hepatologie Picardie

location_facility: Medizinische Hochschule Zentrum Innere Medizin Abt.Gastroenterologie, Endokrinologie und Hepatologie

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin III - Gastroenterologie & Hepatologie

location_facility: Shengjing Hospital of China Medical University

location_facility: Institut Arnault Tzanck; Medecine I Gastro Enterologie

location_facility: Cantonal Hospital Bihac; Department for Infective Diseses

location_facility: Hopital Claude Huriez;Gastro Enterologie

location_facility: Fondation Hopital Saint Joseph; Gastro-Enterologie

location_facility: Bethune International Peace Hospital of PLA

location_facility: Santosa Bandung International Hospital; Hepatology

status_simplified: Completed


title: A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA Versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

summary: The purpose of this study is to compare the efficacy of Bortezomib, Lenalidomide and Dexamethasone (VRd) induction followed by a single administration of ciltacabtagene autoleucel (cilta-cel) versus VRd induction followed by Lenalidomide and Dexamethasone (Rd) maintenance in newly diagnosed multiple myeloma participants for whom ASCT is not planned as initial therapy in terms of Progression Free Survival (PFS).

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

location_country:
Finland
Greece
Australia
Belgium
Denmark
France
Japan
Poland
Norway
Argentina
Canada
Korea, Republic of
Sweden
Switzerland
Netherlands
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Czechia
Israel
Spain

location_facility: A.O. Universitaria Ospedali Riuniti di Ancona

location_facility: Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria

location_facility: Medizinische Universität Graz, LKH-Univ.Klinikum Graz, Klinische Abteilung für Hämatologie

location_facility: Narodowy Instytut Onkologii im.Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz. w Gliwicach

location_facility: Medical University of Vienna,Universitätsklinik für Innere Medizin I

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

location_facility: Klinikum der Eberhard-Karls-Universität/Abt. für innere Med. II/Hämatologie/Onkologie-Germany

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego

location_facility: Attikon University General Hospital of Attica

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Institut Universitaire du cancer de Toulouse-Oncopole

location_facility: Harvard Medical School-Beth Israel Deaconess Medical Center

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

location_facility: Chonnam National University Hwasun Hospital

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

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

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

location_facility: Princess Margaret Cancer Centre University Health Network

location_facility: Oslo universitetssykehus HF, Rikshospitalet

location_facility: University Hospitals Birmingham NHS Trust,

location_facility: Instituto Catalan Deoncologia Hospital Duran I Reynals

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: University Hospital Kyoto Perfectural University of Medicine

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Hospital Privado Universitario de Córdoba

location_facility: IRCCS Azienda Ospedaliera San Martino - IST

location_facility: University of Texas Southwestern Medical Center


title: A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

summary:
The purpose of this Phase 2, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of an oral treatment regimen of CC-220 versus placebo in adult subjects with active systemic lupus erythematosus.

Approximately 280 subjects with a documented diagnosis of SLE will be randomized 2:2:1:2 to receive CC-220 (0.45 mg QD, 0.3 mg QD or 0.15 mg QD) or identically appearing placebo.

ReferenceCitation: Nakayama Y, Kosek J, Capone L, Hur EM, Schafer PH, Ringheim GE. Aiolos Overexpression in Systemic Lupus Erythematosus B Cell Subtypes and BAFF-Induced Memory B Cell Differentiation Are Reduced by CC-220 Modulation of Cereblon Activity. J Immunol. 2017 Oct 1;199(7):2388-2407. doi: 10.4049/jimmunol.1601725. Epub 2017 Aug 28.

ReferenceCitation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3:CD007478. doi: 10.1002/14651858.CD007478.pub2.

name: Dermatologist, Masters of Public Health Program; Harvard School of Public Health; Boston Massachusetts USA

family: Hannon

full_name: Cora W Hannon

given: Cora W

name: Department of Dermatology; Royal Victoria Hospital; Belfast UK

family: McCourt

full_name: Collette McCourt

given: Collette

name: Department of Dermatology, Clinical Unit for Research Trials and Outcomes in Skin (CURTIS); Massachusetts General Hospital; Boston Massachusetts USA

family: Lima

full_name: Hermenio C Lima

given: Hermenio C

name: Emory University Hospital; Emory Healthcare; Atlanta Georgia USA

family: Chen

full_name: Suephy Chen

given: Suephy

name: Office of Research and Innovation; Royal College of Surgeons in Ireland Coláiste Ríoga na Máinleá in Éirinn; Dublin Ireland

family: Bennett

full_name: Cathy Bennett

given: Cathy

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Celgene

location_country:
Italy
United States
Brazil
Serbia
Mexico
Germany
France
Poland
Hungary
Belgium
Argentina
Russian Federation
Spain
Canada
Colombia

location_facility: Hospital Privado Centro Medico de Cordoba

location_facility: University of Pittsburgh UPMC Lupus Center of Excellence

location_facility: University of Florida College of Medicine

location_facility: Voronezh Regional Clinical Hopsital #1, Voronezh State Medical Academy

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Reumatologii i Ukladowych Chorob Tkanki Laczne

location_facility: University of Maryland - School of Medicine

location_facility: Integral Rheumatology and Immunology Specialists

location_facility: Centro de Investigacion en Artritis y Osteoporosis

location_facility: Hospital Universitario Araba - Txagorritxu

location_facility: Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg

location_facility: Institution of the Russian Academy of Medical Sciences Research Institute of Rheumatology of the Ru

location_facility: Clinical and Translational Research Center of Alabama, PC

location_facility: University of California San Diego Medical Center

location_facility: Consultora Integral de Salud Centro Médico Privado

location_facility: Reumalab - Centro Integral de Reumatologia

location_facility: Centro de Estudos em Terapias Inovadoras LTDA

location_facility: Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy

location_facility: Assistance Publique - Hopitaux de Paris - Hopital Universitaire Pitie Salpetriere

location_facility: Centre For Rheumatology, Immun. And Arthritis

location_facility: University of Ferrara, Azienda Ospedaliera-Universitaria S.Anna

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Centro de Imunoterapia de Ipanema (CITIPA)

location_facility: Arthritis and Osteoporosis Associates of New Mexico

location_facility: Saint Petersburg Research Institute for Emergency Medical Care

location_facility: IPS Centro Integral de Reumatologia del Caribe Circaribe S.A.S.

location_facility: Santa Casa de Misericórdia de Belo Horizonte

location_facility: Centro de Alta Especialidad en Reumatología e Investigación del Potosí S.C.

location_facility: Egyesitett Szent Istvan es Szent Laszlo Korhaz - Rendelointezet

location_facility: Clinica Integral de Osteoporosis y Artitis Reumatoide CLINOSAR

location_facility: Advanced Rheumatology & Arthritis Research Center, PC

location_facility: Clinique de Rhumatologie Du Centre Du Quebec

location_facility: Centro de Investigación y Tratamiento Reumatológico

location_facility: University of Pennsylvania Department of Dermatology

location_facility: Hospital General de Agudos Dr. Jose Maria Ramos Mejia

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o.

location_facility: Unidad de Atencion Medica e Investigacion en Salud, S.C.

location_facility: Azienda Ospedaliero - Universitaria di Cagliari

location_facility: Centro Integral en Reumatología, S.A. de C.V.

location_facility: North Shore-LIJ Health System-Division of Rheumatology

location_facility: Samodzielny Publiczny Zespól Opieki Zdrowotnej w Koscianie Szpital im. Teodora Dunina

location_facility: Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S. - Cireem S.A.S

location_facility: Instituto de Investigaciones Clinicas de Quilmes