ReferenceCitation: Jung KH, Ataseven B, Verrill M, Pivot X, De Laurentiis M, Al-Sakaff N, Lauer S, Shing M, Gligorov J, Azim HA. Adjuvant Subcutaneous Trastuzumab for HER2-Positive Early Breast Cancer: Subgroup Analyses of Safety and Active Medical Conditions by Body Weight in the SafeHer Phase III Study. Oncologist. 2018 Oct;23(10):1137-1143. doi: 10.1634/theoncologist.2018-0065. Epub 2018 Jul 17.

name: Asan Medical Center, University of Ulsan College of MedicineSeoul Korea

family: Jung

full_name: Kyung Hae Jung

given: Kyung Hae

name: Department of Obstetrics and Gynecology, University HospitalLMU MunichMunichGermany

family: Ataseven

full_name: Beyhan Ataseven

given: Beyhan

name: Northern Centre for Cancer CareNewcastle upon Tyne UK

family: Verrill

full_name: Mark Verrill

given: Mark

name: Centre Paul Strauss, I'Institut Régional du CancerStrasbourg France

family: Pivot

full_name: Xavier Pivot

given: Xavier

name: Istituto Nazionale Tumori “Fondazione G. Pascale”Naples Italy

family: De Laurentiis

full_name: Michelino De Laurentiis

given: Michelino

name: F. Hoffmann‐La Roche LtdBasel Switzerland

family: Al‐Sakaff

full_name: Nedal Al‐Sakaff

given: Nedal

family: Lauer

full_name: Sabine Lauer

given: Sabine

name: Genentech, Inc.South San Francisco California USA

family: Shing

full_name: Mona Shing

given: Mona

name: APHP‐Tenon; IUC-Sorbonne UniversityParis France

family: Gligorov

full_name: Joseph Gligorov

given: Joseph

name: Oncology Department, School of Medicine, Cairo UniversityCairo Egypt

family: Azim

full_name: Hamdy A. Azim

given: Hamdy A.

journal_name: The Oncologist

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free article)

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

title: Adjuvant Subcutaneous Trastuzumab for HER2‐Positive Early Breast Cancer: Subgroup Analyses of Safety and Active Medical Conditions by Body Weight in the SafeHer Phase III Study

ReferenceCitation: Gligorov J, Ataseven B, Verrill M, De Laurentiis M, Jung KH, Azim HA, Al-Sakaff N, Lauer S, Shing M, Pivot X; SafeHer Study Group. Safety and tolerability of subcutaneous trastuzumab for the adjuvant treatment of human epidermal growth factor receptor 2-positive early breast cancer: SafeHer phase III study's primary analysis of 2573 patients. Eur J Cancer. 2017 Sep;82:237-246. doi: 10.1016/j.ejca.2017.05.010. Epub 2017 Jun 16.

full_name: J. Gligorov

given: J.

full_name: B. Ataseven

given: B.

full_name: M. Verrill

given: M.

full_name: M. De Laurentiis

full_name: K.H. Jung

full_name: H.A. Azim

family: Al-Sakaff

full_name: N. Al-Sakaff

given: N.

full_name: S. Lauer

given: S.

full_name: M. Shing

full_name: Quirine Clementine van Rossum-Schornagel

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

location_country:
Peru
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Greece
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Australia
Russian Federation
Taiwan
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Ecuador
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Spain
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location_facility: Heartlands Hospital; Department Of Medicine

location_facility: IFO - Istituto Regina Elena; Oncologia Medica

location_facility: Complejo Hospitalario Universitario de Albacete; Servicio de Oncologia

location_facility: Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia

location_facility: Ospedale Civile SS Annunziata; oncologia medica

location_facility: Akdeniz University Medical Faculty; Medical Oncology Department

location_facility: Masarykův onkologický ústav; Klinika komplexní onkologické péče

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Ch Lyon Sud; Onco Secteur Jules Courmont

location_facility: Uni Hospital of Alexandroupoli; Dept. of Oncology - Duth

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

location_facility: Forth Valley Royal Hospital ; Oncology Department

location_facility: Katholische Hospitalvereinigung Ostwestfalen gGmbH

location_facility: Maasstad ziekenhuis; Afdeling oncologie hematologie

location_facility: Clinique Radio Des Dentellieres; Chimiotherapie Radiotherapie

location_facility: IRCCS Istituto Clinico Humanitas; Oncologia

location_facility: Clinical Centre Nis, Clinic for Oncology

location_facility: Kyiv City Clinical Oncological Center; Chemotherapy Department

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Hospital Pulau Pinang; Jabatan Radioterapi & Onkologi

location_facility: Oncology Unit, Faculty of Medicine, Vajira Hospital; Department of Medicine

location_facility: Institut of Oncology Al. Trestioreanu Bucharest; Oncology Department

location_facility: Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Prince of Wales Hosp; Dept. Of Clinical Onc

location_facility: Hospital Lluis Alcanys; Servicio de Oncologia

location_facility: NZOZ Onko-Dent SP. P. G. L. Slomian, Poradnia Onkologiczna

location_facility: Ausl Frosinone - Ospedale Umberto I; Divisione Di Oncologia

location_facility: Instituto De Investigaciones Clinicas Zarate

location_facility: Klinikum Leverkusen; Med. Klinik III / Onkologie

location_facility: National Cancer Centre; Medical Oncology

location_facility: Christie Hospital; Breast Cancer Research Office

location_facility: Chp Saint Gregoire; Cancerologie Radiotherapie

location_facility: Leopoldina Krankenhaus der Stadt Schweinfurt GmbH

location_facility: King Faisal Specialist Hospital & Research Centre

location_facility: British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

location_facility: Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia

location_facility: Helse Stavanger HF, Stavanger Universitetssjukehus; Klinikk for Blod og kreftsykdommer

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Instituto Nacional de Cancerologia; Oncology

location_facility: Catharina Ziekenhuis; Dept of Internal Medicin

location_facility: University Medical Centre Maribor; Depart. of Gynecology & Breast Oncology

location_facility: Clinical Hospital Center Bezanijska kosa; Clinic for Oncology

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial

location_facility: Hospital of Lithuanian University of Health. Sciences Kaunas Clinics

location_facility: Università degli Studi Federico II; Clinica di Oncologia Medica

location_facility: Tauranga Hospital, Clinical Trials Unit; BOP Clinical School

location_facility: Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde

location_facility: Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika

location_facility: Kantonsspital Frauenfeld, Frauenklinik Thurgau

location_facility: Caritas Klinik St. Theresia -Frauenklinik Brustzentrum

location_facility: Hospital de Basurto; Servicio de Oncologia

location_facility: City Clinical Oncology Dispensary, SPb SBIH CCOD

location_facility: Tri-Service General Hospital, Division of General Surgery

location_facility: Complex Oncology Center - Plovdiv First Internal Chemotherapy Department

location_facility: Kocaeli University Faculty of Medicine; Medical oncology

location_facility: Hopitaux Du Leman Site Thonon; Maternite Gynecologie

location_facility: Papageorgiou General Hospital; Medical Oncology

location_facility: Consultorio de Medicina Especializada; Dentro de Condominio San Francisco

location_facility: Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia

location_facility: Centre Georges-François Lecler; Ctr de Lutte Contre le Canc

location_facility: Spaarne Ziekenhuis; Inwendige Geneeskunde

location_facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

location_facility: Istanbul Uni of Medicine Faculty; Oncology Dept

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital

location_facility: Hopital Augustin Morvan; Federation De Cancerologie

location_facility: Waterford Regional Hospital; Department Of Medical Oncology

location_facility: ASST DI CREMONA; Unità di Patologia Mammaria Senologia e Breast Unit

location_facility: Pramongkutklao Hospital; Medicine - Medical Oncology Unit

location_facility: Beaumont Hospital; Cancer Clinical Trials Unit

location_facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

location_facility: Department of Surgery, King Chulalongkorn Memorial Hospital

location_facility: Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1

location_facility: Hospital Quiron de Madrid; Servicio de Oncologia

location_facility: CMCO De La Cote D Opale; Auberge De Jour

location_facility: Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine

location_facility: Alexandras General Hospital of Athens; Oncology Department

location_facility: Peninsula and South Eastern Haematology and Oncology Group

location_facility: Hôpital Saint Joseph; Oncologie Medicale

location_facility: Martini Ziekenhuis; Dept of Internal Medicine

location_facility: Kreiskrankenhaus Torgau; Abt.Gynäkologie und Geburtshilfe

location_facility: Institut National D'oncologie Sidi Med Benabdellah

location_facility: Lahn-Dill Kliniken GmbH Klinikum Wetzlar Gynäkologie/Geburtshilfe

location_facility: Fakultna nemocnica s poliklinikou J.A. Reimana Presov

location_facility: Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia

location_facility: Ospedale Oncologico A.Businco; Div. Oncologia Medica II

location_facility: Grupo Oncológico Cooperativo Uruguayo; Hospital de Clínicas - Dpto. de Oncología

location_facility: MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie

location_facility: Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia

location_facility: Skånes University Hospital, Skånes Department of Onclology

location_facility: MHAT Serdika; Department of medical oncology

location_facility: Clinic of Oncology, University Clinical Center Sarajevo

location_facility: National Cheng Kung Uni Hospital; Surgery

location_facility: Ziekenhuis Gelderse Vallei; Inwendige Geneeskunde

location_facility: King Abdul Aziz Medical City, King Fahd National Guard; Oncology

location_facility: Klinikum Meiningen Klinik f.Gynäkologie und Geburtshilfe

location_facility: IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia

location_facility: Hopital Clinique Claude Bernard; Oncologie Medicale

location_facility: National Cancer Institute - Comenius University; Dept. Clinical Oncology

location_facility: St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe

location_facility: Institut de Cancerologie de La Loire; Pneumologie

location_facility: State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis

location_facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

location_facility: Freeman Hospital; Northern Centre For Cancer Care

location_facility: S.C. Life Search S.R.L; Medical Oncology Clinic

location_facility: Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

location_facility: Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach

location_facility: Kantonsspital Winterthur; Medizinische Onkologie

location_facility: University Clinical Center of the Republic of Srpska

location_facility: Hopital Cochin; Unite Fonctionnelle D Oncologie

location_facility: Ospedale Vito Fazzi; Div. Oncoematologia

location_facility: GRN-Klinik Weinheim; Abt.Gynäkologie und Geburtshilfe

location_facility: Ospedale Garibaldi Nesima; Biomedicina Clinica e Molecolare

location_facility: Glan Clwyd Distr Gen Hospital;Nth Wales Cancer Treatment Ctr

location_facility: State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department

location_facility: Universitätsklinikum Jena; Klinik und Poliklinik für Frauenheilkunde und Fortpflanzungsmedizin

location_facility: Klinikum Ludwigsburg; Klinik für Frauenheilkunde und Geburtshilfe

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

location_facility: Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche

location_facility: Ruppiner Kliniken, Klinik fuer Gynaekologie und Geburtshilfe

location_facility: University Malaya Medical Centre; Clinical Oncology Unit,

location_facility: Centro Médico Docente La Trinidad; Unidad de Protocolos Clínicos

location_facility: Vivantes Klinikum Am Urban; Zentrum für Brusterkrankungen

location_facility: Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Philippine General Hospital; Section Of Medical Oncology

location_facility: Solca Guayaquil- Sociedad de Lucha Contra El Cáncer; Oncology

location_facility: Vlietland Ziekenhuis, Locatie Schiedam; Interne Geneeskunde

location_facility: Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum

location_facility: Policlinica Sfanta Maria - Oncology; Medical Oncology

location_facility: Ch Du Mans; Medecine Hematologie Oncologie

location_facility: Derriford Hospital; Plymouth Oncology Centre

location_facility: Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica

location_facility: Universitätsklinikum Hamburg-Eppendorf; Zentrum für operative Medizin Klinik für Gynäkologie

location_facility: Yonsei University Severance Hospital; Medical Oncology

location_facility: Az. Osp. Ospedale Civile; U.O. Di Oncologia Medica Ed Ematologia

location_facility: Aga Khan University; Department of Oncology

location_facility: Klinikum St. Georg GmbH; Franziskus-Hospital Harderberg; Klinik für Gynaekologie und Geburtshilfe

location_facility: Hospital General de Elda; Servicio de Oncologia

location_facility: Internist; Praxis Für Haemotologie & Onkologie

location_facility: Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia

location_facility: The Clatterbridge Cancer Ctr For Oncolgy

location_facility: Krankenhaus St. Elisabeth und St. Barbara, Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Hasan Sadikin Hospital; Internal Medicine

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

location_facility: Gemeinschaftspraxis Dr. Bueckner und Dr. Nueckel

location_facility: Poradnia Onkologiczna oraz Oddzial Kliniczny Onkologii SPZOZ Szpital Uniwersytecki

location_facility: Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg

location_facility: Fakultna nemocnica Trencín; Onkologicke odd.

location_facility: Centre Antoine Lacassagne; B3 Medecine Conventionnelle

location_facility: Gelre Ziekenhuis Apeldoorn, Lokatie Lukas; Afdeling Interne Geneeskunde

location_facility: Sociedad de Investigaciones Medicas Ltda (SIM)

location_facility: Royal Shrewsbury Hospital; Pharmacy Department

location_facility: medius KLINIK OSTFILDERN-RUIT; Brustzentrum

location_facility: Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Centro Estatal de Cancerologia de Nayarit

location_facility: Hospital de Cabueñes; Servicio de Oncologia

location_facility: Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.

location_facility: Asst Papa Giovanni XXIII; Oncologia Medica

location_facility: Mcgill University - Royal Victoria Hospital; Oncology

location_facility: Shifa International Hospital; Department of Oncology

location_facility: Princess Alexandra Hospital; Division of Cancer Services

location_facility: Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Albert Schweitzer Ziekenhuis - loc Dordrecht

location_facility: Hospital de Sao Joao; Servico de Oncologia

location_facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Ospedale Oncologico Regionale; U.O. Oncologia Medica Ed Ematologia

location_facility: Mater Misericordiae Uni Hospital; Oncology

location_facility: Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia

location_facility: IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia

location_facility: Hospital de Navarra; Servicio de Oncologia

location_facility: Kliniken der Stadt Köln gGmbH Krankenhaus Holweide; Brustzentrum

location_facility: DONAU ISAR Klinikum Deggendorf; Frauenklinik

location_facility: Laiko General Hospital; 1St Pathological Clinic

location_facility: Shaukat Khanum Memorial Cancer Hospital; Department of Oncology

location_facility: Rijnstate Ziekenhuis; Inwendige Geneeskunde

location_facility: Hospital General Univ. de Alicante; Servicio de Oncologia

location_facility: Complejo Asistencial Universitario De Burgos; Servicio de Oncologia

location_facility: Sardjito Hospital; Instalasi Kanker Tulip

location_facility: Clinical Hospital 1 Craiova; Medical Oncology

location_facility: Centro Clinico Champalimaud; Oncologia Medica

location_facility: Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia

location_facility: Oslo universitetssykehus HF, Ullevål, Kreftsenteret

location_facility: Inselspital Bern; Universitätsklinik für medizinische Onkologie

location_facility: Queen Elizabeth Hospital; Medical Oncology

location_facility: Praxis Dr. Prechtl & Dr. Kowolik; Frauenklinik

location_facility: Royal Hampshire County Hospital; Winchester & Andover Breast Unit

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Josa Andras Korhaz; Dept of Oncoradiology

location_facility: A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica

location_facility: Centro Oncológico Sixtino / Centro Oncológico SA

location_facility: University Hospital Birmingham Queen Elizabeth Hospital

location_facility: Bashkirian Republican Clinical Oncology Dispensary

location_facility: Instituto de Cáncer SOLCA Cuenca; Oncología

location_facility: Hospital San Pedro De Alcantara; Servicio de Oncologia

location_facility: Prof. Dr. I. Chiricuta Institute of Oncology

location_facility: Princess Alexandra Hospital; Oncology Department

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: Skaraborgs sjukhus Skoevde, Dept of surgery

location_facility: Clinical Hospital Osijek; Dept For Oncology & Radiotherapy

location_facility: Hameed Latif Hospital; Department of Oncology

location_facility: Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Szent Margit Hospital; Dept. of Oncology

location_facility: China Medical University Hospital; Surgery

location_facility: Centre Azureen De Cancerologie; Cons externes

location_facility: Ch Francois Mitterrand; Medecine Oncologie

location_facility: Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy

location_facility: Hospital Do Meixoeiro; Servicio de Oncologia

location_facility: Royal Perth Hospital; Department of Medical Oncology

location_facility: University Hospital of Larissa; Oncology

location_facility: CH Bretagne Sud Site Bodelio; Oncologie Radiotherapie

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori; S. C. Oncologia Medica 2

location_facility: Ankara Uni School of Medicine; Medical Oncology

location_facility: Atrium Medisch Centrum Parkstad, Heerlen

location_facility: Queen Elizabeth Hospital; Clinical Oncology

location_facility: Cluj Clinical County Hospital; Oncology Dept

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii

location_facility: The Royal Wolverhampton Hospitals NHS Trust

location_facility: Ospedale Regionale Di Parma; Divisione Di Oncologia Medica

location_facility: Hospital Pereira Rossell; Oncology Department

location_facility: Clinique Sainte Marguerite; Oncologie Medicale

location_facility: Fakultní Nemocnice V Motole; Radioterapeuticko-Onkologicke Oddeleni

location_facility: Gemeinschaftspraxis Prof. Dr.med. Christoph Salat und Dr.med. Oliver J. Stötzer

location_facility: Ch Bretagne Sud Site Scorff; Oncologie Medicale

location_facility: Emergency University Bucharest Hospital; Oncology Department

location_facility: Gesellschaft für Medizinische Studien Würselen

location_facility: Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Maxima Medisch Centrum; Inwendige Geneeskunde

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding

location_facility: Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica

location_facility: Hospital da Luz; Departamento de Oncologia Medica

location_facility: National Taiwan Uni Hospital; General Surgery

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Johanniter-Krankenhaus Genthin-Stendal; Klinik Für Frauenheilkunde & Geburtshilfe

location_facility: Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care

location_facility: ASKLEPIOS KREISKRANKENHÄUSER WEIßENFELS-HOHENMÖLSEN GMBH

location_facility: Marmara Uni Faculty of Medicine; Medical Oncology

location_facility: Hopital Claude Huriez; Medecine Interne Oncologie

location_facility: 19 Mayis University Medical Faculty; Medical Oncology Department

location_facility: Great Western Hospital, Swindon Cancer Research Unit; Osprey Unit Level 3

location_facility: University "Mother Theresa" Hospital Center; Oncology Department

location_facility: Azienda USL di Ravenna; Unità Operativa di Oncologia Medica

location_facility: Cross Cancer Institute ; Dept of Medical Oncology

location_facility: Hospital Carlos Van Buren, Servicio de Oncologia

location_facility: Periph. University General Hospital of Heraklion Crete; Oncology Department

location_facility: Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia

location_facility: Debreceni Egyetem Klinikai Kozpont ; Department of Oncology

location_facility: Complejo Asistencial Universitario de Leon; Servicio de Oncologia

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem

location_facility: Ch De Brive La Gaillarde; Radiotherapie Oncologie

location_facility: CiptoMangunkusumo Hospital; Internal Medicine

location_facility: Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2

location_facility: IRRCCS San Matteo; Dip Oncoematologico ; Divisione Oncologia

title: A Phase III Prospective, Two-Cohort Non-Randomized, Multi-Centre, Multinational, Open-Label Study to Assess the Safety of Assisted- and Self-Administered Subcutaneous Trastuzumab as Therapy in Patients With Operable HER2-Positive Early Breast Cancer

summary: This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in participants with early HER2-positive breast cancer following tumor excision. Participants will receive Herceptin 600 milligrams (mg) SC every 3 weeks for 18 cycles, either by an assisted administration using a conventional syringe and needle/vial formulation (Cohort A) or with assisted and self-administration using a single-use injection device (SID) in selected participants (Cohort B).


type: EudraCT Number

type: Other Identifier

title: Adjuvant Systemic Treatment for Oestrogen-receptor (ER)-Positive HER2-negative Breast Carcinoma in Women Over 70 According to Genomic Grade (GG): Chemotherapy + Endocrine Treatment Versus Endocrine Treatment. A French UNICANCER Geriatric Oncology Group (GERICO) and Breast Group (UCBG) Multicentre Phase III Trial

acronym: ASTER 70s

summary: The purpose of the study is to evaluate the benefit of adjuvant chemotherapy on overall survival for elderly patients with breast cancer, in a sub group with a high risk of relapse according to Genomic Grade test.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: UNICANCER

location_country: Belgium France

location_facility: Groupement Hospitalier Public du Sud de l'Oise - site de Creil

location_facility: Centre Hôspitalier de Wallonie Picarde (CHWAPI)

location_facility: Institut Curie - Hôpital Claudius Regaud

location_facility: Groupe Hospitalier des Diaconesses - Croix Saint Simon

location_facility: Cliniques universitaires Saint-Luc - UCL

location_facility: RISSA Sarcelles (GCS Recherche & Innovation Santé Sarcelles)

location_facility: Centre d'oncologie et de radiothérapie du Parc

location_facility: Centre Hospitalier Intercommunal de Meulan - Les Mureaux

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Global Multi-centre Observational Study in RA Patients Who Are Non Responders or Intolerant to a Single TNF Inhibitor.

summary: This multicenter, prospective, observational study will assess the efficacy of MabThera/Rituxan (rituximab) and alternative TNF-inhibitors in patients with rheumatoid arthritis who are non-responders or intolerant to a single previous TNF-inhibitor. Data will be collected from each patient from the time of change in biologic therapy for 12 months.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
United Kingdom
Mexico
Spain
France
Greece
Norway
Portugal
Germany
Monaco
Canada
Colombia

status_simplified: Completed


title: A Phase III Clinical Trial of Intra-arterial TheraSphere® in the Treatment of Patients With Unresectable Hepatocellular Carcinoma (HCC)

acronym: STOP-HCC

summary: The safety and effectiveness of TheraSphere will be evaluated in patients with unresectable hepatocellular carcinoma in whom treatment with standard-of-care sorafenib is planned. All patients receive the standard-of-care sorafenib with or without the addition of TheraSphere.

ReferenceType: derived

ReferenceCitation: Chauhan N, Bukovcan J, Boucher E, Cosgrove D, Edeline J, Hamilton B, Kulik L, Master F, Salem R. Intra-Arterial TheraSphere Yttrium-90 Glass Microspheres in the Treatment of Patients With Unresectable Hepatocellular Carcinoma: Protocol for the STOP-HCC Phase 3 Randomized Controlled Trial. JMIR Res Protoc. 2018 Aug 15;7(8):e11234. doi: 10.2196/11234.

family: Chauhan

full_name: Nikhil Chauhan

given: Nikhil

sequence: first

family: Bukovcan

full_name: Janet Bukovcan

given: Janet

sequence: additional

family: Boucher

full_name: Eveline Boucher

given: Eveline

family: Cosgrove

full_name: David Cosgrove

given: David

family: Edeline

full_name: Julien Edeline

given: Julien

family: Hamilton

full_name: Bonnie Hamilton

given: Bonnie

family: Kulik

full_name: Laura Kulik

given: Laura

family: Master

full_name: Fayaz Master

given: Fayaz

family: Salem

full_name: Riad Salem

given: Riad

bso_classification: Medical research

currency_apc_doaj: USD

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: JMIR Research Protocols

oa_colors: green gold

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: JMIR Publications Inc.

publisher_dissemination: JMIR Publications

publisher_group: JMIR Publications

publisher_normalized: JMIR Publications

lead_sponsor: Boston Scientific Corporation

location_country:
Italy
United States
Netherlands
Germany
France
Singapore
Belgium
Spain
Canada
United Kingdom
Korea, Republic of

location_facility: University College London Cancer Institute

location_facility: Universitätsklinikum Leipzig, Klinik für Diagnostische und Interventionelle Radiologie

location_facility: Azienda Ospedaliero -Universitaria di Bologna

location_facility: Banner - University Medical Center Phoenix

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: Servicio de Radiología, Hospital Universitario Virgen de la Arrixaca.

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: McGill University Health Centre / Royal Victoria Hospital

location_facility: Seattle Cancer Care Alliance/University of Washington Medical Center

location_facility: Hosptal Universitario Central de Asturias (nuevo HUCA)

location_facility: Hospital Clínico Universitario Lozano Blesa

location_facility: Keimyung University Dongsan Medical Center

location_facility: Universitätsklinikum Tübingen, Diagnostische und Interventionelle Radiologie

intervention_type: Device


ReferenceCitation: Conroy T, Hammel P, Hebbar M, Ben Abdelghani M, Wei AC, Raoul JL, Choné L, Francois E, Artru P, Biagi JJ, Lecomte T, Assenat E, Faroux R, Ychou M, Volet J, Sauvanet A, Breysacher G, Di Fiore F, Cripps C, Kavan P, Texereau P, Bouhier-Leporrier K, Khemissa-Akouz F, Legoux JL, Juzyna B, Gourgou S, O'Callaghan CJ, Jouffroy-Zeller C, Rat P, Malka D, Castan F, Bachet JB; Canadian Cancer Trials Group and the Unicancer-GI-PRODIGE Group. FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer. N Engl J Med. 2018 Dec 20;379(25):2395-2406. doi: 10.1056/NEJMoa1809775.

name: From the Institut de Cancérologie de Lorraine and Université de Lorraine (T.C.) and Centre Hospitalier Universitaire (L.C.), Nancy, Hôpital Beaujon and University Paris VII, Clichy (P.H., A.S.), Hôpital Huriez, Lille (M.H.), Centre Paul Strauss, Strasbourg (M.B.A.), Institut Paoli-Calmettes, Marseille (J.-L.R.), Centre Antoine-Lacassagne, Nice (E.F.), Hôpital Jean-Mermoz, Lyon (P.A.), Hôpital Trousseau, Tours (T.L.), Centre Hospitalier Universitaire de Saint-Eloi (E.A.) and Institut du Cancer de...

family: Conroy

full_name: Thierry Conroy

given: Thierry

family: Hammel

full_name: Pascal Hammel

given: Pascal

family: Hebbar

full_name: Mohamed Hebbar

given: Mohamed

family: Ben Abdelghani

full_name: Meher Ben Abdelghani

given: Meher

family: Wei

full_name: Alice C. Wei

given: Alice C.

family: Raoul

full_name: Jean-Luc Raoul

given: Jean-Luc

family: Choné

full_name: Laurence Choné

given: Laurence

family: Francois

full_name: Eric Francois

given: Eric

family: Artru

full_name: Pascal Artru

family: Biagi

full_name: James J. Biagi

given: James J.

family: Lecomte

full_name: Thierry Lecomte

family: Assenat

full_name: Eric Assenat

family: Faroux

full_name: Roger Faroux

given: Roger

family: Ychou

full_name: Marc Ychou

given: Marc

family: Volet

full_name: Julien Volet

family: Sauvanet

full_name: Alain Sauvanet

given: Alain

family: Breysacher

full_name: Gilles Breysacher

given: Gilles

family: Di Fiore

full_name: Frédéric Di Fiore

given: Frédéric

family: Cripps

full_name: Christine Cripps

given: Christine

family: Kavan

full_name: Petr Kavan

given: Petr

family: Texereau

full_name: Patrick Texereau

given: Patrick

family: Bouhier-Leporrier

full_name: Karine Bouhier-Leporrier

given: Karine

family: Khemissa-Akouz

full_name: Faiza Khemissa-Akouz

given: Faiza

family: Legoux

full_name: Jean-Louis Legoux

given: Jean-Louis

family: Juzyna

full_name: Béata Juzyna

given: Béata

location_facility: CancerCare Manitoba, St. Boniface General Hospital

location_facility: Fondation Ambroise Paré / Hôpital Européen

location_facility: The Royal Victoria Hospital - Cancer Care Program

location_facility: Department of Medical Oncology Health Sciences North

location_facility: General Surgery - TGH Site, Univ. Health Network

location_facility: Algoma District Cancer Program, Sault Area Hospital

location_facility: Juravinski Cancer centre at Hamilton Health Sciences

location_facility: Cancer Centre of Southeastern Ontario at Kingston General Hospital

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: Saskatoon Cancer Centre, University of Saskatchewan

location_facility: McGill University (Department of Oncology)

title: Multicentric Randomized Phase III Trial Comparing Adjuvant Chemotherapy With Gemcitabine Versus 5-fluorouracil, Leucovorin, Irinotecan and Oxaliplatin (mFolfirinox) in Patients With Resected Pancreatic Adenocarcinoma

summary: This is a multicentric randomized phase III trial comparing adjuvant chemotherapy with gemcitabine versus 5-fluorouracil, leucovorin, irinotecan and oxaliplatin (mFolfirinox) in patients with resected pancreatic adenocarcinoma.


title: Medtronic Product Surveillance Registry

acronym: PSR

summary: The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.

status: Recruiting

enrollment_type: Anticipated

ReferenceCitation: Garg A, Koneru JN, Fagan DH, Stromberg K, Padala SK, El-Chami MF, Roberts PR, Piccini JP, Cheng A, Ellenbogen KA. Morbidity and mortality in patients precluded for transvenous pacemaker implantation: Experience with a leadless pacemaker. Heart Rhythm. 2020 Dec;17(12):2056-2063. doi: 10.1016/j.hrthm.2020.07.035. Epub 2020 Aug 4.

family: Garg

full_name: Aatish Garg

given: Aatish

family: Koneru

full_name: Jayanthi N. Koneru

given: Jayanthi N.

family: Fagan

full_name: Dedra H. Fagan

given: Dedra H.

family: Stromberg

full_name: Kurt Stromberg

given: Kurt

family: Padala

full_name: Santosh K. Padala

given: Santosh K.

family: El-Chami

full_name: Mikhael F. El-Chami

given: Mikhael F.

family: Roberts

full_name: Paul R. Roberts

given: Paul R.

family: Piccini

full_name: Jonathan P. Piccini

given: Jonathan P.

family: Cheng

full_name: Alan Cheng

given: Alan

family: Ellenbogen

full_name: Kenneth A. Ellenbogen

given: Kenneth A.

journal_name: Heart Rhythm

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Singh JP, Cha YM, Lunati M, Chung ES, Li S, Smeets P, O'Donnell D. Real-world behavior of CRT pacing using the AdaptivCRT algorithm on patient outcomes: Effect on mortality and atrial fibrillation incidence. J Cardiovasc Electrophysiol. 2020 Apr;31(4):825-833. doi: 10.1111/jce.14376. Epub 2020 Feb 28.

name: Cardiology DivisionMassachusetts General Hospital Boston Massachusetts

family: Singh

full_name: Jagmeet P. Singh

given: Jagmeet P.

name: Department of Cardiovascular MedicineMayo Clinic Rochester Minnesota

family: Cha

full_name: Yong‐Mei Cha

given: Yong‐Mei

name: Department of Cardiology/Cardiac‐Thoracic‐Vascular SurgeryOspedale Niguarda Niguarda Italy

family: Lunati

full_name: Maurizio Lunati

given: Maurizio

name: The Lindner Clinical Research CenterThe Heart and Vascular Center at the Christ Hospital Cincinnati Ohio

family: Chung

full_name: Eugene S. Chung

given: Eugene S.

family: Li

full_name: Shelby Li

given: Shelby

name: Medtronic Bakken Research Center Maastricht Netherlands

family: Smeets

full_name: Pascal Smeets

given: Pascal

name: Department of ElectrophysiologyGenesisCare Heidelberg Victoria Australia

family: O'Donnell

full_name: David O'Donnell

given: David

journal_name: Journal of Cardiovascular Electrophysiology

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

title: Real‐world behavior of CRT pacing using the AdaptivCRT algorithm on patient outcomes: Effect on mortality and atrial fibrillation incidence

ReferenceCitation: Stearns LM, Abd-Elsayed A, Perruchoud C, Spencer R, Hammond K, Stromberg K, Weaver T. Intrathecal Drug Delivery Systems for Cancer Pain: An Analysis of a Prospective, Multicenter Product Surveillance Registry. Anesth Analg. 2020 Feb;130(2):289-297. doi: 10.1213/ANE.0000000000004425.

publisher: Ovid Technologies (Wolters Kluwer Health)

location_country:
Finland
Malaysia
Greece
Australia
Belgium
Russian Federation
Denmark
Iceland
India
Spain
France
Japan
Poland
Slovakia
Kuwait
Norway
Argentina
Canada
Slovenia
Korea, Republic of
Colombia
South Africa
Chile
Sweden
United Arab Emirates
Saudi Arabia
Hong Kong
Netherlands
Switzerland
Hungary
Puerto Rico
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Czechia
Israel
Kazakhstan
Turkey


title: LUX-Lung 8: A Randomized, Open-label Phase III Trial of Afatinib Versus Erlotinib in Patients With Advanced Squamous Cell Carcinoma of the Lung as Second-line Therapy Following First-line Platinum-based Chemotherapy

summary: This randomised, open-label phase III trial will be performed in patients with advanced squamous cell carcinoma of the lung requiring second-line treatment after receiving first-line platinum-based chemotherapy. The primary objective of this trial is to compare the efficacy of BIBW 2992 to erlotinib as second-line treatment in this group of patients.

ReferenceCitation: Lu S, Li W, Zhou C, Hu CP, Qin S, Cheng G, Feng J, Wang J, Cseh A, Peil B, Gibson N, Ehrnrooth E, Zhang L. Afatinib vs erlotinib for second-line treatment of Chinese patients with advanced squamous cell carcinoma of the lung. Onco Targets Ther. 2018 Nov 30;11:8565-8573. doi: 10.2147/OTT.S161506. eCollection 2018.

family: Lu

full_name: Shun Lu

given: Shun

full_name: Wei Li

given: Wei

family: Zhou

full_name: Caicun Zhou

given: Caicun

family: Hu

full_name: Cheng-Ping Hu

given: Cheng-Ping

family: Qin

full_name: Shukui Qin

given: Shukui

full_name: Gang Cheng

given: Gang

family: Feng

full_name: Jifeng Feng

given: Jifeng

family: Wang

full_name: Jie Wang

given: Jie

family: Cseh

full_name: Agnieszka Cseh

given: Agnieszka

family: Peil

full_name: Barbara Peil

given: Barbara

family: Gibson

full_name: Neil Gibson

given: Neil

family: Ehrnrooth

full_name: Eva Ehrnrooth

given: Eva

family: Zhang

full_name: Li Zhang

given: Li

journal_name: OncoTargets and Therapy

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Goss GD, Felip E, Cobo M, Lu S, Syrigos K, Lee KH, Göker E, Georgoulias V, Li W, Guclu S, Isla D, Min YJ, Morabito A, Ardizzoni A, Gadgeel SM, Fülöp A, Bühnemann C, Gibson N, Krämer N, Solca F, Cseh A, Ehrnrooth E, Soria JC. Association of ERBB Mutations With Clinical Outcomes of Afatinib- or Erlotinib-Treated Patients With Lung Squamous Cell Carcinoma: Secondary Analysis of the LUX-Lung 8 Randomized Clinical Trial. JAMA Oncol. 2018 Sep 1;4(9):1189-1197. doi: 10.1001/jamaoncol.2018.0775.

name: Division of Medical Oncology, The Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada

family: Goss

full_name: Glenwood D. Goss

given: Glenwood D.

name: Department of Medical Oncology, Vall d’Hebron University Hospital, Barcelona, Spain

family: Felip

name: Department of Medical Oncology, Hospital Universitario Málaga General, Instituto de Investigación Biomédica de Málaga, Málaga, Spain

name: Shanghai Chest Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China

name: Oncology Unit GPP, Athens School of Medicine, Athens, Greece

name: Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, South Korea

name: Ege University Faculty of Medicine, Izmir, Turkey

name: Department of Medical Oncology, University Hospital of Heraklion, Heraklion, Crete, Greece

name: Cancer Center, First Hospital Affiliated to Jilin University, Jilin, China

name: Chest Diseases Clinic, Izmir Chest Diseases Research Hospital, Izmir, Turkey

name: Medical Oncology Department, University Hospital Lozano Blesa, Zaragoza, Spain

name: Department of Medicine, Ulsan University Hospital, Ulsan, South Korea

name: Medical Oncology Unit, Thoraco-Pulmonary Department, Istituto Nazionale Tumori-IRCCS-“Fondazione G. Pascale,” Naples, Italy

name: Division of Medical Oncology, Sant’Orsola-Malpighi University Hospital, Bologna, Italy

name: Department of Oncology, Karmanos Cancer Institute/Wayne State University, Detroit, Michigan

name: National Koranyi Institute, Budapest, Hungary

name: Staburo GmbH, Munich, Germany, on behalf of Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany

name: Boehringer Ingelheim RCV GmbH & Co KG, Vienna, Austria

name: Boehringer Ingelheim, Danmark A/S, Denmark

name: Department of Medical Oncology, Gustave Roussy Cancer Campus and University Paris-Sud, Paris, France

ReferenceCitation: Gadgeel S, Goss G, Soria JC, Felip E, Georgoulias V, Lu S, Cobo M, Syrigos K, Lee KH, Göker E, Guclu SZ, Isla D, Morabito A, Dupuis N, Bühnemann C, Krämer N, Solca F, Ehrnrooth E, Ardizzoni A. Evaluation of the VeriStrat(®) serum protein test in patients with advanced squamous cell carcinoma of the lung treated with second-line afatinib or erlotinib in the phase III LUX-Lung 8 study. Lung Cancer. 2017 Jul;109:101-108. doi: 10.1016/j.lungcan.2017.05.010. Epub 2017 May 11.

title: Evaluation of the VeriStrat ® serum protein test in patients with advanced squamous cell carcinoma of the lung treated with second-line afatinib or erlotinib in the phase III LUX-Lung 8 study

ReferenceCitation: Soria JC, Felip E, Cobo M, Lu S, Syrigos K, Lee KH, Göker E, Georgoulias V, Li W, Isla D, Guclu SZ, Morabito A, Min YJ, Ardizzoni A, Gadgeel SM, Wang B, Chand VK, Goss GD; LUX-Lung 8 Investigators. Afatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung (LUX-Lung 8): an open-label randomised controlled phase 3 trial. Lancet Oncol. 2015 Aug;16(8):897-907. doi: 10.1016/S1470-2045(15)00006-6. Epub 2015 Jul 5.

repository_institution: Borys Grinchenko Kyiv University - Медицинский Совет

location_country:
Greece
Denmark
Taiwan
India
France
Argentina
Canada
Korea, Republic of
Chile
Netherlands
Singapore
Hungary
Ireland
China
Portugal
United States
Germany
United Kingdom
Italy
Austria
Mexico
Spain
Turkey

location_facility: General Hospital of Chest Diseases Sotiria

location_facility: Paris Cancer Center (PCC), Texas Oncology

location_facility: Aladar Petz County Teaching Hospital, Dept. Pulmonology

location_facility: Instituto de Terapias Oncologicas Providencia

location_facility: University of Pecs, 1st internal Med. Dept., Pulmonology

location_facility: The Ohio State University Wexner Medical Center

location_facility: Ege Universitesi Tip Fakultesi Tibbi Onkoloji Bilim Dali

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Johns Hopkins Singapore International Medical Centre

location_facility: National Koranyi TBC and Pulm. Internal Med. Clinic

location_facility: Centro Internacional de Estudios Clinicos - CIEC

location_facility: Gaziantep Univ. Tip Fakultesi Tibbi Onkoloji Bilim Dali

location_facility: University Hospital of Larisa, Oncology Clinic

location_facility: P.O. Bellaria IRCCS Istituto delle scienze Neurologiche di Bologna

location_facility: St. Antonius ziekenhuis, locatie Nieuwegein

location_facility: Oncology Hematology Associates of Norhtern Pennsylvania, PC

location_facility: Lung Hospital of Matra, Dept. Pulmonology

location_facility: Boca Raton Reginl Hospital-Lynn Cancer Institute

location_facility: Ospedale Molinette, AO Città della Salute e della

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: Cancer Center of Cookeville Regional Medical Center

location_facility: Washington University School of Medicine

location_facility: Xiangya Hospital, Central South University

location_facility: Seoul National University Bundang Hospital

location_facility: Sri Ramachandra Medical College & Research Institute

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Istituto Nazionale Tumori Fondazione Pascale

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

location_facility: Maidstone Hospital, Kent Oncology Centre

location_facility: B. P .Poddar Hospital & Medical Research Ltd.

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: Pest County Lung Hospital, Department No. 3

location_facility: Pulmonology Institute of Veszprem County, Farkasgyepu

location_facility: SMZ Baumgartner Hoehe Otto Wagner Spital

location_facility: Institute of Chest Diseases Csongrad County,Dpt. Pulmonology

location_facility: Hospital Regional Universitario de Málaga

location_facility: West Jefferson General Hospital and Cancer Clinic

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

location_facility: Uludag Universitesi Tip Fakultesi, Bursa

location_facility: Koo Foundation Sun Yet-Sen Cancer Center

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

location_facility: METC Academisch Ziekenhuis Maastricht/Universiteit van Maastricht

location_facility: University General Hospital of Heraklion

location_facility: "Hippokratio" Hospital of Athens, 2nd Internal Medicine Clin

location_facility: Centro Hemato-Oncologico Privado de Toluca S.A. de C.V.


title: An Observational, Non-Interventional, Multi-Center, Multi-National Study of Patients With Atypical Hemolytic-Uremic Syndrome (aHUS Registry)

summary: Post-marketing safety data on patients treated and untreated with eculizumab or ravulizumab.

time_perspective: Other

ReferenceCitation: Woodward L, Johnson S, Walle JV, Beck J, Gasteyger C, Licht C, Ariceta G; aHUS Registry SAB. An innovative and collaborative partnership between patients with rare disease and industry-supported registries: the Global aHUS Registry. Orphanet J Rare Dis. 2016 Nov 21;11(1):154. Review.

ReferenceCitation: Licht C, Ardissino G, Ariceta G, Cohen D, Cole JA, Gasteyger C, Greenbaum LA, Johnson S, Ogawa M, Schaefer F, Vande Walle J, Frémeaux-Bacchi V. The global aHUS registry: methodology and initial patient characteristics. BMC Nephrol. 2015 Dec 10;16:207. doi: 10.1186/s12882-015-0195-1.

family: Licht

full_name: Christoph Licht

given: Christoph

family: Ardissino

full_name: Gianluigi Ardissino

given: Gianluigi

family: Ariceta

full_name: Gema Ariceta

given: Gema

family: Cohen

full_name: David Cohen

family: Cole

full_name: J. Alexander Cole

given: J. Alexander

family: Gasteyger

full_name: Christoph Gasteyger

family: Greenbaum

full_name: Larry A. Greenbaum

given: Larry A.

family: Johnson

full_name: Sally Johnson

given: Sally

family: Ogawa

full_name: Masayo Ogawa

given: Masayo

family: Schaefer

full_name: Franz Schaefer

given: Franz

family: Vande Walle

full_name: Johan Vande Walle

given: Johan

family: Frémeaux-Bacchi

full_name: Véronique Frémeaux-Bacchi

given: Véronique

currency_apc_doaj: GBP

journal_name: BMC Nephrology

repository_institution: Heidelberg University - heiDOK - The Heidelberg Document Repository

repository_institution: Ghent University - Ghent University Academic Bibliography

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: Newcastle Univesity - Newcastle University ePrints

publisher: Springer Science and Business Media LLC

ReferenceCitation: Belingheri M, Possenti I, Tel F, Paglialonga F, Testa S, Salardi S, Ardissino G. Cryptic activity of atypical hemolytic uremic syndrome and eculizumab treatment. Pediatrics. 2014 Jun;133(6):e1769-71. doi: 10.1542/peds.2013-2921. Epub 2014 May 19.

title: Cryptic Activity of Atypical Hemolytic Uremic Syndrome and Eculizumab Treatment

ReferenceCitation: Ardissino G, Possenti I, Tel F, Testa S, Paglialonga F. Time to change the definition of hemolytic uremic syndrome. Eur J Intern Med. 2014 Feb;25(2):e29. doi: 10.1016/j.ejim.2013.12.002. Epub 2013 Dec 21.

location_country:
Italy
United States
Germany
France
Poland
Israel
Belgium
Australia
Russian Federation
Spain
Denmark
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: U O Nefrologia e Dialisi Pediatrica Ospedale Giovanni XXIII

location_facility: Cliniques Universitaires Saint-Luc (adult)

location_facility: Severance Hospital Yonsei University Health System

location_facility: HEGP - Hopital Europeen Georges Pompidou

location_facility: Pad Croff Nefrologia Ospedale Maggiore Policlinico

location_facility: Pusan National University Yangsan Hospital

location_facility: Cliniques Universitaires Saint-Luc (Pediatric)

location_facility: Le Centre Hospitialier Universitarie de Nice Hopital Pasteur

location_facility: Medizinische Hochschule Hannover Adult Nephrology

location_facility: CHRU de Caen Hopital Clemenceau Service de Nephrologie

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Klinkzny

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

location_facility: CHU de Liege - Clinique de l'Esperance (pediatric)

location_facility: Fondazione IRCCS Ca Granda, Ospedale Maggiore Policlinico

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Washington University School of Medicine

location_facility: Dipartmento di Nefrologia e Urologia Ospedale Pediatrico Bambin Gesu

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Emory Children's Center Emory University

location_facility: S C Nefrologia - A O Ospedale Niguarda-Ca Granda

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: University of Florida, Division of Nephrology

location_facility: National Taiwan University Hospital (NTUH)

location_facility: Children's City Clinical Hospital of Saint Vladimir

location_facility: Sverdlovsk Regional Clinical Hospital No. 1

location_facility: Veteran's General Hospital - Kaohsiung (VGH-KS)

location_facility: Hopital Robert Debre Service de Nephrologie Pediatrique

location_facility: China Medical University Hospital (CMUH)

location_facility: Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: Royal Devon & Exeter NHS Foundation Trust

location_facility: Centre Hospitialier Regional de Chambery

location_facility: Hopital Necker, Enfants Malades Service de Nephrologie Pediatrique

location_facility: Chang Cung Memorial Hospital - LK (CGMH-LK)

location_facility: Medizinische Hochschule Hannover Pediatric Nephrology


title: A Multinational, Randomised, Open-labelled, Parallel Group Four Months Comparison of Twice Daily Biphasic Human Insulin 30 and Thrice Daily Biphasic Insulin Aspart 50 and 70 in Subjects With Type 1 or Type 2 Diabetes

summary: This trial is conducted in Europe. The aim of this trial is to compare the glycaemic control of biphasic insulin aspart (BIAsp) 70 and/or BIAsp 50 with biphasic human insulin (BHI) 30 treatment.

ReferenceType: result

ReferenceCitation: Clements MR, Tits J, Kinsley BT, Råstam J, Friberg HH, Ligthelm RJ. Improved glycaemic control of thrice-daily biphasic insulin aspart compared with twice-daily biphasic human insulin; a randomized, open-label trial in patients with type 1 or type 2 diabetes. Diabetes Obes Metab. 2008 Mar;10(3):229-37. doi: 10.1111/j.1463-1326.2006.00687.x.

family: Clements

full_name: M. R. Clements

given: M. R.

family: Tits

full_name: J. Tits

given: J.

family: Kinsley

full_name: B. T. Kinsley

given: B. T.

family: Råstam

full_name: J. Råstam

family: Friberg

full_name: H. H. Friberg

given: H. H.

family: Ligthelm

full_name: R. J. Ligthelm

given: R. J.

journal_name: Diabetes, Obesity and Metabolism

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Novo Nordisk A/S

location_country:
Netherlands
France
Ireland
Belgium
United Kingdom


title: A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma

acronym: IMAGE

summary: The purpose of this study is to examine the safety of Ipilimumab and patterns of use in the treatment of unresectable or metastatic melanoma in the post-approval setting.

status: Unknown status

ReferenceCitation: Dalle S, Mortier L, Corrie P, Lotem M, Board R, Arance AM, Meiss F, Terheyden P, Gutzmer R, Buysse B, Oh K, Brokaw J, Le TK, Mathias SD, Scotto J, Lord-Bessen J, Moshyk A, Kotapati S, Middleton MR. Long-term real-world experience with ipilimumab and non-ipilimumab therapies in advanced melanoma: the IMAGE study. BMC Cancer. 2021 May 29;21(1):642. doi: 10.1186/s12885-021-08032-y.

family: Dalle

full_name: Stéphane Dalle

given: Stéphane

family: Mortier

full_name: Laurent Mortier

given: Laurent

family: Corrie

full_name: Pippa Corrie

given: Pippa

family: Lotem

full_name: Michal Lotem

given: Michal

family: Board

full_name: Ruth Board

given: Ruth

family: Arance

full_name: Ana María Arance

given: Ana María

family: Meiss

full_name: Frank Meiss

given: Frank

family: Terheyden

full_name: Patrick Terheyden

given: Patrick

family: Gutzmer

full_name: Ralf Gutzmer

given: Ralf

family: Buysse

full_name: Brian Buysse

given: Brian

family: Oh

full_name: Kelly Oh

given: Kelly

family: Brokaw

full_name: Jane Brokaw

given: Jane

family: Le

full_name: T. Kim Le

given: T. Kim

family: Mathias

full_name: Susan D. Mathias

given: Susan D.

family: Scotto

full_name: Julie Scotto

given: Julie

family: Lord-Bessen

full_name: Jennifer Lord-Bessen

given: Jennifer

family: Moshyk

full_name: Andriy Moshyk

given: Andriy

family: Kotapati

full_name: Srividya Kotapati

given: Srividya

family: Middleton

full_name: Mark R. Middleton

given: Mark R.

journal_name: BMC Cancer

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

repository_institution: Université de Lille (University Of Lille) - LillOA

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central
ora.ox.ac.uk

location_country:
Austria
Switzerland
Germany
France
Poland
Greece
Israel
Ireland
Argentina
Australia
Belgium
Spain
United States
United Kingdom
Canada

location_facility:
Local Institutio
Local Institution
Local institution


status: Terminated

lead_sponsor: Spectrum Pharmaceuticals, Inc

location_country:
Italy
Austria
United States
Netherlands
France
Israel
Ireland
Australia
Belgium
Puerto Rico
Spain
Canada
United Kingdom

acronym: Zevalin in patients with Diffuse Large B-cell Lymphoma

location_facility: CH de la Côte Basque, Service d'Hématologie

location_facility: University of Iowa Hospitals and Clinics

location_facility: Spaarne Ziekenhuis, Internal Medicine/Ocology

location_facility: Service d'Hématologie Centre Henri Becquerel

location_facility: Department of Haematology Bristol Royal Infirmary

location_facility: Oncology Research-Park Nicollet Institute

location_facility: Hackensack UMC / John Theurer Cancer Center

location_facility: Policlinico S Orsola Malpighi, Istituto di Ematologia ''L.e A. Seragnoli''

location_facility: University Medical Centre Groningen (UMCG)

location_facility: Thunder Bay Regional Health Sciences Centre-Regional Cancer Care

location_facility: Northwestern University Feinberg School of Medicine

location_facility: St. Luke's Mountain States Tumor Institute (MSTI)

location_facility: Azienda Ospedaliera San. Giovanni Battista di Torino, Dipartimento di Oncologia U.O.A Ematologia, Le Molinette,

location_facility: Decatur Memorial Hospital Cancer Care Specialists of Central Illinois

location_facility: Nuclear Medicine Physician, Jules Bordet Institute

location_facility: The Christie NHS Foundation Trust, The Christie Hospital,

location_facility: York Cancer Center / Cancer Care Associates of York

location_facility: University Medical Center Radboud Nijmegen

location_facility: New Ematologia dell'Ospedale "Spedali Civili" di Brescia

location_facility: The University of Texas M.D. Anderson Cancer Center

location_facility: Centre François Baclesse, Comite Hématologie

source: euctr

title: A Phase 3, Open-label, Multicenter, Randomized Study of Sequential Zevalin (Ibritumomab Tiuxetan) Versus Observation in Patients at Least 60 Years of Age With Newly Diagnosed Diffuse Large B-cell Lymphoma in PET-negative Complete Remission After R-CHOP or R-CHOP-like Therapy

summary: The purpose of this study is to evaluate the efficacy and safety of Zevalin compared with observation alone in patients who are in PET-negative complete remission after first-line R-CHOP or R-CHOP like therapy.

status_simplified: Unknown


title: A Multicenter, Multinational, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra® When Used In Routine Medical Practice (LIBERATE)

acronym: LIBERATE

summary: The primary objective of the study is to collect additional safety data including the incidence rate of seizure and other specific Adverse Events (AEs) of interest from participants taking Fampyra in routine clinical practice. The secondary objectives of this study are to characterize utilization patterns of Fampyra in routine clinical practice, to assess the effectiveness of risk minimization measures as described in the risk management plan for Fampyra, to assess the change over time in participant self-reported evaluation of the physical and psychological impact of Multiple Sclerosis (MS) while taking Fampyra and to assess the change over time in physician assessment of walking ability in participants taking Fampyra (MS participants only).

ReferenceCitation: Castelnovo G, Gerlach O, Freedman MS, Bergmann A, Sinay V, Castillo-Triviño T, Kong G, Koster T, Williams H, Gafson AR, Killestein J. Safety, Patient-Reported Well-Being, and Physician-Reported Assessment of Walking Ability in Patients with Multiple Sclerosis for Prolonged-Release Fampridine Treatment in Routine Clinical Practice: Results of the LIBERATE Study. CNS Drugs. 2021 Sep;35(9):1009-1022. doi: 10.1007/s40263-021-00840-x. Epub 2021 Jul 28.

family: Castelnovo

full_name: Giovanni Castelnovo

given: Giovanni

family: Gerlach

full_name: Oliver Gerlach

given: Oliver

family: Freedman

full_name: Mark S. Freedman

given: Mark S.

family: Bergmann

full_name: Arnfin Bergmann

given: Arnfin

family: Sinay

full_name: Vladimiro Sinay

given: Vladimiro

family: Castillo-Triviño

full_name: Tamara Castillo-Triviño

given: Tamara

family: Kong

full_name: George Kong

given: George

family: Koster

full_name: Thijs Koster

given: Thijs

family: Williams

full_name: Heather Williams

given: Heather

family: Gafson

full_name: Arie R. Gafson

given: Arie R.

family: Killestein

full_name: Joep Killestein

given: Joep

journal_name: CNS Drugs

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Biogen

location_country:
United Arab Emirates
Lebanon
Netherlands
Spain
France
Czechia
Israel
Norway
Ireland
Argentina
Portugal
Germany
Canada

location_facility:
Research Site
Research site
Rsearch Site
Reasearch Center
Site Research


title: A Prospective Randomised Phase III Trial to Evaluate Optimal Treatment Duration of First-line Bevacizumab in Combination With Carboplatin and Paclitaxel in Patients With Primary Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer

acronym: BOOST

summary: The purpose of this study is to determine whether the early and continuous addition of bevacizumab for up to 30 months to the standard chemotherapy is more effective than the early and continuous addition of bevacizumab for up to 15 months.

ipd_sharing: No

lead_sponsor: AGO Study Group

location_country: Sweden Finland France Norway Denmark Germany

intervention_type: Other


ReferenceCitation: Theodore-Oklota C, Humphrey L, Wiesner C, Schnetzler G, Hudgens S, Campbell A. Validation of a treatment satisfaction questionnaire in non-Hodgkin lymphoma: assessing the change from intravenous to subcutaneous administration of rituximab. Patient Prefer Adherence. 2016 Sep 13;10:1767-1776. eCollection 2016.

ReferenceCitation: Rule S, Collins GP, Samanta K. Subcutaneous vs intravenous rituximab in patients with non-Hodgkin lymphoma: a time and motion study in the United Kingdom. J Med Econ. 2014 Jul;17(7):459-68. doi: 10.3111/13696998.2014.914033. Epub 2014 May 7.

family: Rule

full_name: Simon Rule

given: Simon

family: Collins

full_name: Graham P. Collins

given: Graham P.

family: Samanta

full_name: Kunal Samanta

given: Kunal

journal_name: Journal of Medical Economics

publisher: Informa Healthcare

location_country:
Greece
Romania
Russian Federation
Ecuador
France
Lithuania
Slovakia
Norway
Argentina
Slovenia
Colombia
Sweden
Switzerland
Bulgaria
Hungary
Germany
United Kingdom
Italy
Austria
Brazil
Albania
Egypt
Spain
Turkey

acronym: MabCute

location_facility: St. Olavs Hospital HF, Kreftavdelingen, Gastrosentret

location_facility: BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie

location_facility: Ch Du Mans; Medecine Hematologie Oncologie

location_facility: Centro de Tratamento Oncologico - CETRON

location_facility: Centre Hospitalier de La Cote Basque; Hematologie

location_facility: Dres. Andreas Hübner, Andreas Lück und Petra Bruhn

location_facility: Spitalul Clinic municipal de Urgenta Timisoara; Clinica de Hematologie

location_facility: Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol

location_facility: Centre Hospitalier Uni Ire; Service Des Maladies Du Sang

location_facility: Uni Di Verona Policlinico G.B. Rossi; Divisione E Cattedra Di Ematologia

location_facility: National Institute of Oncology, A Dept of Internal Medicine

location_facility: N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis

location_facility: Churchill Hospital; Oxford Cancer and Haematology Centre

location_facility: Instituto de Ensino e Pesquisa Sao Lucas - IEP

location_facility: UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Hämatologie & Hämostaseologie

location_facility: Hospital Quiron de Madrid; Servicio de Hematologia

location_facility: Hacettepe Uni Medical Faculty; Hematology

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: County Clinical Emergency Hospital Brasov

location_facility: Birmingham Heartlands Hospital; Department of Haematology

location_facility: Gemeinschaftspraxis Dr. Bueckner und Dr. Nueckel

location_facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica

location_facility: Klinikum rechts der Isar der TU München; III. Medizinischen Klinik (Hämatologie/Onkologie)

location_facility: Instituto Nacional de Cancerologia; Hematology

location_facility: Hospital Univ. Central de Asturias; servicio de Hematologia

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

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Hematologia

location_facility: Hospital Royo Villanova; Servicio de Hematologia

location_facility: Gemeinschaftspraxis Dr. med. J. Mohm und Dr. med. G. Prange-Krex; Fachaerzte fuer Innere Medizin

location_facility: A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna

location_facility: Royal Liverpool Uni Hospital; Haematology

location_facility: Södersjukhuset, Medicinkliniken/Sektionen för Hematologi

location_facility: Klinik der Uni Regensburg; Hämatologie/Onkologie, Studienzentrale

location_facility: Uni Hospital ; Dept. of Haematol. & Transfusion Medicine

location_facility: Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik

location_facility: Västmanlands sjukhus Västerås, Onkologmottagningen

location_facility: Dres. Emil Höring Matthias Respondek und Ulrike Schwinger

location_facility: Norfolk & Norwich Hospital; Dept of Haematology

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Hematologia

location_facility: Uni Hospital of Wales; Dept of Haematology

location_facility: Hospital Duran i Reynals; Servicio de Hematologia

location_facility: A.O. Universitaria Federico II Di Napoli; Oncologia Ed Endocrinologia Clinica

location_facility: Kent & Canterbury Hospital; Clinical Haematology

location_facility: Complejo Hospitalario Universitario de Ourense, Servicio de Hematologia

location_facility: University Hospital of Ioannina; Hematology

location_facility: Internistisch-Onkologische Gemeinschaftspraxis; Dres. Rohrberg, Hurtz, Schma usw.

location_facility: A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1

location_facility: Hôpital Lapeyronie; Hématologie Oncologie Médicale

location_facility: Spitalul Clinic Coltea; Clinica de Hematologie

location_facility: Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia

location_facility: Uni of Debrecen; 2Nd Clinic of Internal Medicine

location_facility: University of Pecs, I st Dept of Internal Medicine

location_facility: Kasr Eieny Uni Hospital; Oncology (Nemrock)

location_facility: Semmelweis University, First Dept of Medicine

location_facility: Helse Stavanger HF, Stavanger Universitetssjukehus; Klinikk for Blod og kreftsykdommer

location_facility: Hospital General Universitario de Elche; Servicio de Oncologia

location_facility: Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora

location_facility: Ospedale Cardarelli; Divisione Di Ematologia

location_facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie

location_facility: Teodoro Maldonado Carbo Hospital; Oncology Service

location_facility: The Royal Marsden Hospital; Dept of Medicine

location_facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio Hematologia

location_facility: Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine

location_facility: Royal Marsden Hospital; Dept. of Medicine

location_facility: Hopital Pitie Salpetriere; Hematologie Clinique

location_facility: Dres. Barbara Tschechne Stefanie Luft und Wolf-Oliver Jordan

location_facility: Hospital das Clinicas - FMUSP; Hematologia

location_facility: Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach

location_facility: Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

location_facility: Hospital de Jerez de la Frontera; Servicio de Hematologia

location_facility: Hamatol Onkol Praxisgemeinschaft Dres H H-D Schick/D Schick

location_facility: Centre Hospitalier Departemental Les Oudairies

location_facility: University Hospital of Larissa; Hematology Dept.

location_facility: St. Johannes Hospital; Abt. für Hämatologie und Onkologie

location_facility: Royal Bournemouth General Hospital; Haematology

location_facility: A.O. Universitaria S. Martino Di Genova; Ematologia 1

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

location_facility: Az. Osp. Di Careggi; Divisione Di Ematologia

location_facility: Hopital De Haut Leveque; Hematologie Clinique

location_facility: Hospital Arnau de Vilanova (Valencia) Servicio de Hematologia

location_facility: Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica

location_facility: Marmara University Pendik Training and Research Hospital, Hematology Department

location_facility: Capio, S:T Gorans Hospital; Dept of Medicine

location_facility: Complejo Hospitalario de Jaen- Hospital Universitario Medico Quirurgico; Servicio de Hematologia

location_facility: Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia

location_facility: CH Henri Mondor; Med Interne Neuro Endocrinologie

location_facility: Ch Sud Francilien; Hematologie Oncologie

location_facility: Kepler Universitätskliniken GmbH - Med Campus III; III. Medizinische Abteilung

location_facility: Ospedale Santa Chiara; Unita Operativa Di Ematologia

location_facility: Ospedale Ferrarotto; Divisione Di Ematologia

location_facility: Institut d'Hématologie de Basse Normandie

location_facility: University "Mother Theresa" Hospital Center; Oncology Department

location_facility: Dres. Richard Hansen Susanne Pfitzner-Dempfle und Manfred Reeb

location_facility: Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie

location_facility: Complejo Hospitalario Zamora- H. Virgen de la Concha; Servicio de Hematología

location_facility: A.O.U. Policlinico di Modena-Dipartimento di Medicina Diagnostica, Clinica e di Sanità pubblica

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia

location_facility: Centre Antoine Lacassagne;B4 Hematologie Cancerologie

location_facility: Rus Med Academy for Postgraduate Education; Oncology Department

location_facility: Hôpital Albert Michallon; Hematologie Clinique

location_facility: Nottingham City Hospital; Dept of Haematology

location_facility: Tokuda Hospital Sofia; Hematology department

location_facility: Klinikum Darmstadt GmbH; Med. Klinik V; Onkologie & Hämatologie

location_facility: Dres. Michael Maasberg Marion Schmitz und Maria Theresia Keller

location_facility: University Hospital Of Patras; Dept. Of Internal Medicine-Hematology Division

location_facility: Hopital Andre Mignot; Hematologie - Oncologie

location_facility: Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica

location_facility: Hospital San Pedro De Alcantara; Servicio de Hematologia

location_facility: Istanbul Uni Capa Medical Faculty; Inst. of Oncology

location_facility: Leicester Royal Infirmary; Dept of Haematology

location_facility: Oslo Universitetssykehus HF; Radiumhospitalet

location_facility: Chu Estaing; Hematologie Clinique Adultes

location_facility: General Hospital of Athens Evangelismos; Hematology

location_facility: Staedtisches Krankenhaus Muenchen-Schwabing, Haematologie & Onkolgie

location_facility: Lkh-Univ. Klinikum Graz; Klin. Abt. Für Hämatologie

location_facility: Azienda Sanitaria Di Bolzano; Ematologia E Centro Trapianto Mid.Osseo

location_facility: National Oncology Inst. ; Dept. of Haematology

location_facility: Hospital Universitario San Cecilio; Servicio de Oncologia

location_facility: Hospital Universitario de Canarias;servicio de Hematologia

location_facility: Hopital Hotel Dieu Et Hme; Clinique Dermatologique

location_facility: University College London, Department of Haematology

title: A Randomized Study Comparing Maintenance Therapy With Subcutaneous Rituximab Continued Until Progression With Observation Only in Patients With Relapsed or Refractory, Indolent Non-Hodgkin's Lymphoma Who Completed and Responded to Rituximab-based Immunochemotherapy Induction and Initial 2-year Rituximab Maintenance Therapy Administered Subcutaneously

summary: This multicenter, randomized, open-label, parallel-group study will evaluate the efficacy and safety of subcutaneously administered rituximab in comparison with observation only as maintenance therapy in participants with relapsed or refractory indolent Non-Hodgkin's lymphoma (NHL). All participants will receive induction therapy with rituximab (375 milligrams per square meter [mg/m^2] intravenously [IV] in Cycle 1, then 1400 mg subcutaneous [SC] every 3-4 weeks) plus standard chemotherapy for 6-8 months; followed by 24 months of maintenance I period with rituximab (1400 mg SC every 8 weeks). Participants completing therapy and showing partial or complete response will be randomized to receive either rituximab (1400 mg SC every 8 weeks) or observation with no treatment during maintenance II period and will be followed for at least 15 months. Anticipated time on study treatment is until disease progression, unacceptable toxicity or end of study, whichever occurs first.


title: International, Prospective, Open-label, Multicenter, Pharmacoepidemiological Study to Determine Predictors of Clinical Outcomes in Chemotherapy-treated Cancer Patients at Risk for Febrile Neutropenia and Treated Prophylactically With Filgrastim Biosimilar.

acronym: Monitor-GCSF

summary: This international, prospective, observational, open-label, pharmaco-epidemiologic study observes cancer patients at risk for chemotherapy-induced febrile neutropenia (FN) who are receiving filgrastim biosimilar (EP2006) for primary or secondary FN prophylaxis to better describe the patient population at risk for FN and treated prophylactically in physician's best clinical judgement with filgrastim biosimilar (EP2006), to describe prophylaxis patterns involving filgrastim biosimilar (EP2006), and to evaluate hematology levels and variability in hematological outcomes, impact on chemotherapy delivery, radiotherapy, surgery, and mortality. Additionally the study aims to identify patient cohorts who are vulnerable to poor response to FN prophylaxis and experience break-through episodes of FN, understand the differences between prophylaxis responders and non-responders, and describe the degree to which prophylaxis of FN is in congruence with guideline recommendations.

lead_sponsor: Sandoz

location_country:
Italy
Austria
Switzerland
United Kingdom
France
Poland
Romania
Hungary
Belgium
Spain
Germany
Czech Republic


title: Non-Interventional Cohort Study on the Utilization and Impact of Dual and Triple Therapies Based on Pegylated Interferon for the Treatment of Chronic Hepatitis C

summary: This prospective, multicenter, observational cohort study will evaluate the efficacy and safety of pegylated interferon alfa (peginterferon alfa) (e.g. Pegasys) plus ribavirin and treatment regimens containing direct-acting antivirals in participants with chronic hepatitis C who are treatment-naïve or treatment-experienced and HIV HCV co-infected. Data will be collected from participants receiving treatment according to current Summary of Product Characteristics (SPC) and local labeling for the duration of their treatment and a 24-week follow-up.

location_country: Macedonia, The Former Yugoslav Republic of


title: Electronic Assessment of Quality of Life in Patients With Symptomatic Chemotherapy-induced Anaemia: An International Prospective Observational Study (eAQUA)

summary:
This is a multicenter, international, prospective, observational study of patients who are receiving systemic chemotherapy for solid tumour cancers (breast, colorectal, ovarian, prostate, lung, bladder, endometrial, renal, pancreatic, esophageal or gastric) and who are receiving darbepoetin alfa (Aranesp®) or other erythropoiesis-stimulating agent (ESA) to treat symptomatic anaemia.

Quality of Life will be assessed electronically with the aim of estimating improvement in quality of life for those patients receiving darbepoetin alfa (Aranesp®) who also have an increase in haemoglobin (Hb) of ≥1 g/dL

ReferenceType: background

ReferenceCitation: Mouysset JL, Freier B, van den Bosch J, Levaché CB, Bols A, Tessen HW, Belton L, Bohac GC, Terwey JH, Tonini G. Hemoglobin levels and quality of life in patients with symptomatic chemotherapy-induced anemia: the eAQUA study. Cancer Manag Res. 2016 Jan 21;8:1-10. doi: 10.2147/CMAR.S88110. eCollection 2016.

lead_sponsor: Amgen

location_country: Italy Austria Netherlands France Poland Greece Romania Belgium Germany


acronym: ISIS-ICD

summary: ISIS- ICD study has been designed to evaluate the impact of PARAD+ algorithm on inappropriate shocks, in a general population implanted for primary or secondary prevention with a dual or tri chamber device at one year follow-up

ReferenceCitation: Ruiz-Granell R, Dovellini EV, Dompnier A, Khalighi K, García-Campo E, Olivier A, Barcelo A, Ritter P. Algorithm-based reduction of inappropriate defibrillator shock: Results of the Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination-Implantable Cardioverter Defibrillator Study. Heart Rhythm. 2019 Sep;16(9):1429-1435. doi: 10.1016/j.hrthm.2019.03.016. Epub 2019 Mar 22.

family: Ruiz-Granell

full_name: Ricardo Ruiz-Granell

given: Ricardo

family: Dovellini

full_name: Emilio Vincenzo Dovellini

given: Emilio Vincenzo

family: Dompnier

full_name: Antoine Dompnier

given: Antoine

family: Khalighi

full_name: Koroush Khalighi

given: Koroush

family: García-Campo

full_name: Enrique García-Campo

given: Enrique

family: Olivier

full_name: Audrey Olivier

given: Audrey

family: Barcelo

full_name: Aina Barcelo

given: Aina

family: Ritter

full_name: Philippe Ritter

given: Philippe

oa_host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

title: Algorithm-based reduction of inappropriate defibrillator shock: Results of the Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination–Implantable Cardioverter Defibrillator Study

lead_sponsor: MicroPort CRM

location_country:
Italy
United States
France
Japan
Spain
Germany
United Kingdom

location_facility: Southern California Electrophysiology Associates

location_facility: Centre Hospitalier Universitaire de La Timone

location_facility: Universitatsklinikum Schleswig-Holstein Campus Lübeck

location_facility: Tokyo Medical and Dental University Hospital

location_facility: CHU Groupe Hospitalo-universitaire Caremeau

location_facility: Klinik für Kardiologie Städtisches Klinikum Lüneburg gGmbH

location_facility: Centre Hospitalier Universitaire D'Amiens

location_facility: Kardiologische Praxis Dr. med Taggeselle

location_facility: Pitt Memeorial Hospital Heart Rhythm Associates

location_facility: CHRU du Morvan Hôpital la Cavale Blanche

location_facility: Policlinico Consorziale di Bari U.O Cardiologia Universitaria


title: Randomized Phase III Study of a Treatment Driven by Early PET Response Compared to a Treatment Not Monitored by Early PET in Patients With Ann Arbor Stage III-IV or High Risk IIB Hodgkin Lymphoma

summary:
All study treatments have proven efficacy in the treatment in Hodgkin lymphoma (HL). It is hoped that patients will achieve a good response to both induction therapies consisting either of 4 cycles of BEACOPPesc (Bleomycin, Etoposide, Doxorubicin, Cyclophosphamide, Vincristine, Procarbazine, and Prednisone) or 2 cycles of BEACOPPesc plus 2 cycles of ABVD (Adriamycine, Bléomycine, Vinblastine, Décarbazine).

The use of F-FDG Position Emission Tomography performed after 2 cycles of chemotherapy (PET2) in the experimental arm will help to stratify patients in order to restrict the BEACOPPesc therapy continuation to those patients who achieved only a partial response after 2 BEACOPPesc regimen and to allow a conventional dose ABVD chemotherapy strategy for PET2 negative patients. For all patients included in the trial the achievement of a good response to induction treatment will be checked after four cycles of induction treatment including a centrally reviewed PET assessment

Patients will be randomized after verification of eligibility and before the start of the protocol treatment.Patients will be randomly assigned to the standard treatment arm not monitored by early PET, or the experimental treatment arm driven by the PET2 result.

ReferenceCitation: Demeestere I, Racape J, Dechene J, Dupuis J, Morschhauser F, De Wilde V, Lazarovici J, Ghesquieres H, Touati M, Sibon D, Alexis M, Gac AC, Moatti H, Virelizier E, Maisonneuve H, Pranger D, Houot R, Fornecker LM, Tempescul A, André M, Casasnovas RO. Gonadal Function Recovery in Patients With Advanced Hodgkin Lymphoma Treated With a PET-Adapted Regimen: Prospective Analysis of a Randomized Phase III Trial (AHL2011). J Clin Oncol. 2021 Oct 10;39(29):3251-3260. doi: 10.1200/JCO.21.00068. Epub 2021 Jun 22.

name: Research Laboratory on Human Reproduction and Fertility Clinic, CUB-Erasme, Université Libre de Bruxelles, Brussels, Belgium

family: Demeestere

full_name: Isabelle Demeestere

given: Isabelle

name: Research Center in Epidemiology, Biostatistics and Clinical Research, School of Public Health, and Biomedical Research Department, CUB-Erasme, Université Libre de Bruxelles, Brussels, Belgium

family: Racape

full_name: Judith Racape

given: Judith

name: Research Laboratory on Human Reproduction, Université Libre de Bruxelles, Brussels, Belgium

family: Dechene

full_name: Julie Dechene

given: Julie

name: Department of Haematology, Hopital H. Mondor, Creteil, France

family: Dupuis

full_name: Jehan Dupuis

given: Jehan

name: Department of Hematology, University of Lille, CHU Lille, EA 7365—GRITA—Groupe de Recherche sur les formes Injectables et les Technologies Associées, Lille, France

family: Morschhauser

full_name: Franck Morschhauser

given: Franck

name: Department of Haematology, CUB-Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium

family: De Wilde

full_name: Virginie De Wilde

given: Virginie

name: Department of Haematology Gustave Roussy, Université Paris-Saclay, Villejuif, France

family: Lazarovici

full_name: Julien Lazarovici

given: Julien

name: Department of Haematology, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, et Université Claude Bernard Lyon-1, Pierre Bénite, France

family: Ghesquieres

full_name: Hervé Ghesquieres

given: Hervé

name: Department of Haematology, CHU Limoges, Limoges, France

family: Touati

full_name: Mohamed Touati

given: Mohamed

name: Department of Haematology, Hopital Necker, Paris, France

family: Sibon

full_name: David Sibon

given: David

name: Department of Haematology, CH Orleans, Orleans, France

family: Alexis

full_name: Magda Alexis

given: Magda

name: Department of Haematology, Institut d'hématologie de basse normandie, Caen, France

family: Gac

full_name: Anne-Claire Gac

given: Anne-Claire

name: Department of Haematology, APHP, Hopital Saint Louis, Paris, France

family: Moatti

full_name: Hannah Moatti

given: Hannah

name: Department of Haematology, Centre L. Bérard, Lyon, France

family: Virelizier

full_name: Emmanuelle Virelizier

given: Emmanuelle

name: Department of Haematology, Hopital departemental de Vendée, La Roche sur Yon, France

family: Maisonneuve

full_name: Hervé Maisonneuve

name: Department of Haematology, Grand Hopital de Charleroi, Charleroi, Belgium

family: Pranger

full_name: Delphine Pranger

given: Delphine

name: Department of Hematology, University Hospital of Rennes, Rennes, France

family: Houot

full_name: Roch Houot

given: Roch

name: Department of Hematology, University Hospital of Strasbourg, Strasbourg, France

family: Fornecker

full_name: Luc-Matthieu Fornecker

given: Luc-Matthieu

name: Department of Hematology, University Hospital of Brest, Brest, France

family: Tempescul

full_name: Adrian Tempescul

given: Adrian

name: Department of Haematology, CHU UCL Namur, Université catholique de Louvain, Yvoir, Belgium

family: André

full_name: Marc André

given: Marc

name: Department of Haematology, University Hospital F Mitterrand and Inserm UMR1231, Dijon, France

family: Casasnovas

full_name: René-Olivier Casasnovas

given: René-Olivier

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Casasnovas RO, Bouabdallah R, Brice P, Lazarovici J, Ghesquieres H, Stamatoullas A, Dupuis J, Gac AC, Gastinne T, Joly B, Bouabdallah K, Nicolas-Virelizier E, Feugier P, Morschhauser F, Delarue R, Farhat H, Quittet P, Berriolo-Riedinger A, Tempescul A, Edeline V, Maisonneuve H, Fornecker LM, Lamy T, Delmer A, Dartigues P, Martin L, André M, Mounier N, Traverse-Glehen A, Meignan M. PET-adapted treatment for newly diagnosed advanced Hodgkin lymphoma (AHL2011): a randomised, multicentre, non-inferiority, phase 3 study. Lancet Oncol. 2019 Feb;20(2):202-215. doi: 10.1016/S1470-2045(18)30784-8. Epub 2019 Jan 15.

family: Bouabdallah

full_name: Reda Bouabdallah

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Lille

location_facility: Institut Curie - Hopital Claudius Régaud

location_facility: CHU de Strasbourg-Hopital de Hautepierre

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: CHU Haut Leveque - Centre François Magendie

location_facility: Hopitaux Civil de Colmar - Hopital Pasteur


title: A 30 Day International, Randomized, Parallel-group, Double-blind, Placebo-controlled Phase IV Study to Evaluate Efficacy and Safety of Pre-hospital vs. In-hospital Initiation of Ticagrelor Therapy in STEMI Patients Planned for PCI.

acronym: ATLANTIC

summary:
The aim of this study is to determine whether initiation of ticagrelor as early as in the ambulance setting leads to a rapid reperfusion of the infarct-related artery therefore facilitating the Percutaneous Coronary Intervention (PCI) and optimizing the outcome for the patient.

The study will assess the efficacy and safety of pre-hospital compared to in-hospital administration of ticagrelor in co-administration with aspirin, on restoring the blood flow in the occluded heart artery and improving the myocardial perfusion in patients suffering from myocardial infarction and planned to have a PCI. Patients can be randomised in either one of the 2 arms:

re-hospital ticagrelor arm: Patients will receive a loading dose of 180 mg ticagrelor for the pre-hospital administration and placebo for in-hospital administration.

or In-hospital ticagrelor arm: Patients will receive a placebo for pre-hospital administration and 180 mg ticagrelor loading dose for in-hospital administration.

Patients are initially managed by ambulance physician/personnel in pre hospital settings. They are then transferred into a Catheterization room to undergo a PCI.

After the administration of the loading dose of ticagrelor (double blind), patients will continue on ticagrelor 90 mg bid and be followed in study for 30 days post randomisation.

ReferenceCitation: Montalescot G, van 't Hof AW, Lapostolle F, Silvain J, Lassen JF, Bolognese L, Cantor WJ, Cequier A, Chettibi M, Goodman SG, Hammett CJ, Huber K, Janzon M, Merkely B, Storey RF, Zeymer U, Stibbe O, Ecollan P, Heutz WM, Swahn E, Collet JP, Willems FF, Baradat C, Licour M, Tsatsaris A, Vicaut E, Hamm CW; ATLANTIC Investigators. Prehospital ticagrelor in ST-segment elevation myocardial infarction. N Engl J Med. 2014 Sep 11;371(11):1016-27. doi: 10.1056/NEJMoa1407024. Epub 2014 Sep 1.

family: Montalescot

full_name: Gilles Montalescot

given: Gilles

family: van 't Hof

full_name: Arnoud W. van 't Hof

given: Arnoud W.

family: Lapostolle

full_name: Frédéric Lapostolle

given: Frédéric

family: Silvain

full_name: Johanne Silvain

given: Johanne

family: Lassen

full_name: Jens Flensted Lassen

given: Jens Flensted

family: Bolognese

full_name: Leonardo Bolognese

given: Leonardo

family: Cantor

full_name: Warren J. Cantor

given: Warren J.

family: Cequier

full_name: Ángel Cequier

given: Ángel

family: Chettibi

full_name: Mohamed Chettibi

family: Goodman

full_name: Shaun G. Goodman

given: Shaun G.

family: Hammett

full_name: Christopher J. Hammett

given: Christopher J.

family: Huber

full_name: Kurt Huber

given: Kurt

family: Janzon

full_name: Magnus Janzon

given: Magnus

family: Merkely

full_name: Béla Merkely

given: Béla

family: Storey

full_name: Robert F. Storey

given: Robert F.

family: Zeymer

full_name: Uwe Zeymer

given: Uwe

family: Stibbe

full_name: Olivier Stibbe

given: Olivier

family: Ecollan

full_name: Patrick Ecollan

given: Patrick

family: Heutz

full_name: Wim M.J.M. Heutz

given: Wim M.J.M.

family: Swahn

full_name: Eva Swahn

given: Eva

family: Collet

full_name: Jean-Philippe Collet

given: Jean-Philippe

family: Willems

full_name: Frank F. Willems

given: Frank F.

family: Baradat

full_name: Caroline Baradat

given: Caroline

repository_institution: Consorci de Serveis Universitaris de Catalunya - RECERCAT

title: Prehospital Ticagrelor in ST-Segment Elevation Myocardial Infarction

ReferenceCitation: Lapostolle F, Van't Hof AW, Hamm CW, Stibbe O, Ecollan P, Collet JP, Silvain J, Lassen JF, Heutz WMJM, Bolognese L, Cantor WJ, Cequier A, Chettibi M, Goodman SG, Hammett CJ, Huber K, Janzon M, Merkely B, Storey RF, Ten Berg J, Zeymer U, Licour M, Tsatsaris A, Montalescot G; ATLANTIC Investigators. Morphine and Ticagrelor Interaction in Primary Percutaneous Coronary Intervention in ST-Segment Elevation Myocardial Infarction: ATLANTIC-Morphine. Am J Cardiovasc Drugs. 2019 Apr;19(2):173-183. doi: 10.1007/s40256-018-0305-0.

journal_name: American Journal of Cardiovascular Drugs

ReferenceCitation: Fabris E, Van't Hof A, Hamm CW, Lapostolle F, Lassen JF, Goodman SG, Ten Berg JM, Bolognese L, Cequier A, Chettibi M, Hammett CJ, Huber K, Janzon M, Merkely B, Storey RF, Zeymer U, Cantor WJ, Kerneis M, Diallo A, Vicaut E, Montalescot G; ATLANTIC investigators. Pre-hospital administration of ticagrelor in diabetic patients with ST-elevation myocardial infarction undergoing primary angioplasty: A sub-analysis of the ATLANTIC trial. Catheter Cardiovasc Interv. 2019 Jun 1;93(7):E369-E377. doi: 10.1002/ccd.27921. Epub 2018 Oct 9.

name: Cardiology Department; Isala Heart Center; Zwolle the Netherlands

name: Cardiovascular Department; University of Trieste; Trieste Italy

name: Department of Cardiology; Maastricht University Medical Center; Maastricht the Netherlands

name: Department of Cardiology; Zuyderland Hospital; Heerlen the Netherlands

name: Kerckhoff Heart and Thorax Center; Bad Nauheim Germany

name: SAMU 93 Hôpital Avicenne; Bobigny France

name: Department of Cardiology B; Aarhus University Hospital; Aarhus Denmark

name: Canadian Heart Research Centre, Division of Cardiology; St. Michael's Hospital, University of Toronto; Toronto Canada

name: Department of Cardiology; St. Antonius Hospital Nieuwegein; Nieuwegein the Netherlands

name: Cardiovascular and Neurological Department; Azienda Ospedaliera Arezzo; Arezzo Italy

name: Heart Disease Institute; Hospital Universitario de Bellvitge, University of Barcelona; Spain

name: Centre Hospito-universitaire Frantz Fanon; Blida Algeria

name: Department of Cardiology; Royal Brisbane and Women's Hospital; Brisbane Queensland Australia

name: 3rd Department of Medicine, Cardiology and Intensive Care Medicine; Wilhelminen hospital and Sigmund Freud University, Medical School; Vienna Austria

name: Department of Cardiology and Department of Medical and Health Sciences; Linköping University; Linköping Sweden

name: Heart and Vascular Center; Semmelweis University; Budapest Hungary

name: Department of Infection, Immunity and Cardiovascular Disease; University of Sheffield; Sheffield United Kingdom

name: Klinikum Ludwigshafen and Institut für Herzinfarktforschung; Ludwigshafen Germany

name: Southlake Regional Health Centre; University of Toronto; Ontario Canada

name: Sorbonne Université, ACTION Study Group; Hospital Pitie-Salpetriere (AP-HP); Paris France

name: Hospital Lariboisiere; ACTION Study Group; Paris France

journal_name: Catheterization and Cardiovascular Interventions

ReferenceCitation: Bagai A, Goodman SG, Cantor WJ, Vicaut E, Bolognese L, Cequier A, Chettibi M, Hammett CJ, Huber K, Janzon M, Lapostolle F, Lassen JF, Merkely B, Storey RF, Ten Berg JM, Zeymer U, Diallo A, Hamm CW, Tsatsaris A, El Khoury J, Van't Hof AW, Montalescot G. Duration of ischemia and treatment effects of pre- versus in-hospital ticagrelor in patients with ST-segment elevation myocardial infarction: Insights from the ATLANTIC study. Am Heart J. 2018 Feb;196:56-64. doi: 10.1016/j.ahj.2017.10.021. Epub 2017 Nov 4.

ReferenceCitation: Kilic S, Fabris E, Van't Hof AWJ, Hamm CW, Lapostolle F, Lassen JF, Tsatsaris A, Diallo A, Vicaut E, Montalescot G; ATLANTIC Investigators. Thrombus aspiration and prehospital ticagrelor administration in ST-elevation myocardial infarction: Findings from the ATLANTIC trial. Am Heart J. 2018 Feb;196:1-8. doi: 10.1016/j.ahj.2017.09.018. Epub 2017 Oct 3.

ReferenceCitation: Venetsanos D, Sederholm Lawesson S, Alfredsson J, Janzon M, Cequier A, Chettibi M, Goodman SG, Van't Hof AW, Montalescot G, Swahn E. Association between gender and short-term outcome in patients with ST elevation myocardial infraction participating in the international, prospective, randomised Administration of Ticagrelor in the catheterisation Laboratory or in the Ambulance for New ST elevation myocardial Infarction to open the Coronary artery (ATLANTIC) trial: a prespecified analysis. BMJ Open. 2017 Sep 21;7(9):e015241. doi: 10.1136/bmjopen-2016-015241.

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

ReferenceCitation: Cayla G, Lapostolle F, Ecollan P, Stibbe O, Benezet JF, Henry P, Hammett CJ, Lassen JF, Storey RF, Ten Berg JM, Hamm CW, Van't Hof AW, Montalescot G; ACTION study group. Pre-hospital ticagrelor in ST-segment elevation myocardial infarction in the French ATLANTIC population. Int J Cardiol. 2017 Oct 1;244:49-53. doi: 10.1016/j.ijcard.2017.06.009. Epub 2017 Jun 9.

ReferenceCitation: Lupi A, Schaffer A, Lazzero M, Tessitori M, De Martino L, Rognoni A, Bongo AS, Porto I. Pre-hospital ticagrelor in patients with ST-segment elevation myocardial infarction with long transport time to primary PCI facility. Cardiovasc Revasc Med. 2016 Dec;17(8):528-534. doi: 10.1016/j.carrev.2016.08.005. Epub 2016 Aug 20.

ReferenceCitation: Silvain J, Storey RF, Cayla G, Esteve JB, Dillinger JG, Rousseau H, Tsatsaris A, Baradat C, Salhi N, Hamm CW, Lapostolle F, Lassen JF, Collet JP, Ten Berg JM, Van't Hof AW, Montalescot G. P2Y12 receptor inhibition and effect of morphine in patients undergoing primary PCI for ST-segment elevation myocardial infarction. The PRIVATE-ATLANTIC study. Thromb Haemost. 2016 Aug 1;116(2):369-78. doi: 10.1160/TH15-12-0944. Epub 2015 May 19.

ReferenceCitation: Montalescot G, van 't Hof AW, Bolognese L, Cantor WJ, Cequier A, Chettibi M, Collet JP, Goodman SG, Hammett CJ, Huber K, Janzon M, Lapostolle F, Lassen JF, Licour M, Merkely B, Salhi N, Silvain J, Storey RF, Ten Berg JM, Tsatsaris A, Zeymer U, Vicaut E, Hamm CW; ATLANTIC Investigators. Effect of Pre-Hospital Ticagrelor During the First 24 h After Primary Percutaneous Coronary Intervention in Patients With ST-Segment Elevation Myocardial Infarction: The ATLANTIC-H²⁴ Analysis. JACC Cardiovasc Interv. 2016 Apr 11;9(7):646-56. doi: 10.1016/j.jcin.2015.12.024. Epub 2016 Mar 5.

ReferenceCitation: Montalescot G, Lassen JF, Hamm CW, Lapostolle F, Silvain J, ten Berg JM, Cantor WJ, Goodman SG, Licour M, Tsatsaris A, van't Hof AW. Ambulance or in-catheterization laboratory administration of ticagrelor for primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: rationale and design of the randomized, double-blind Administration of Ticagrelor in the cath Lab or in the Ambulance for New ST elevation myocardial Infarction to open the Coronary artery (ATLANTIC) study. Am Heart J. 2013 Apr;165(4):515-22. doi: 10.1016/j.ahj.2012.12.015. Epub 2013 Feb 13.

title: Ambulance or in-catheterization laboratory administration of ticagrelor for primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: Rationale and design of the randomized, double-blind Administration of Ticagrelor in the cath Lab or in the Ambulance for New ST elevation myocardial Infarction to open the Coronary artery (ATLANTIC) study

location_country:
Italy
Austria
Sweden
Netherlands
Germany
France
Hungary
Australia
Algeria
Spain
Denmark
Canada
United Kingdom


title: A Randomised, Double-blind Study to Evaluate the Efficacy and Safety of Avastin Plus Roferon Compared With Placebo Plus Roferon on Overall Survival and Tumor Assessment in Nephrectomised Patients With Metastatic Clear Cell Renal Cell Carcinoma

summary: This 2-arm study will evaluate the efficacy and safety of Avastin versus placebo in combination with Roferon as first-line treatment in participants with metastatic renal cell cancer (clear cell type) who have had nephrectomy. The anticipated time of study treatment is 1-2 years, and the target sample size is greater than (>)500 individuals.

location_country:
Italy
Switzerland
Netherlands
Spain
United Kingdom
Finland
France
Poland
Israel
Norway
Hungary
Belgium
Australia
Russian Federation
Singapore
Germany
Czech Republic
Taiwan