acronym: TAO

lead_sponsor: Sanofi

summary:
Primary Objective:

To demonstrate the superior efficacy (composite of all-cause death + Myocardial Infarction (MI)) of Otamixaban to Unfractionated Heparin (UFH) + Eptifibatide

Secondary Objectives:

To demonstrate the superior efficacy (composite of all-cause death + MI + any stroke) of Otamixaban as compared to UFH + Eptifibatide
To document the effect of Otamixaban on rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia/myocardial infarction as compared to UFH + eptifibatide
To document the effect on mortality (all cause death) of Otamixaban as compared to UFH + eptifibatide
To document the safety of Otamixaban as compared to UFH + eptifibatide
To document the effect of Otamixaban on thrombotic procedural complications during the index Percutaneous Coronary Intervention (PCI) as compared to UFH + eptifibatide

ReferenceCitation: Steg PG, Mehta SR, Pollack CV Jr, Bode C, Gaudin C, Fanouillere K, Moryusef A, Wiviott SD, Sabatine MS. Design and rationale of the treatment of acute coronary syndromes with otamixaban trial: a double-blind triple-dummy 2-stage randomized trial comparing otamixaban to unfractionated heparin and eptifibatide in non-ST-segment elevation acute coronary syndromes with a planned early invasive strategy. Am Heart J. 2012 Dec;164(6):817-24.e13. doi: 10.1016/j.ahj.2012.10.001. Epub 2012 Nov 7.

ReferenceCitation: Steg PG, Mehta SR, Pollack CV Jr, Bode C, Cohen M, French WJ, Hoekstra J, Rao SV, Ruzyllo W, Ruiz-Nodar JM, Sabate M, Widimsky P, Kiss RG, Navarro Estrada JL, Hod H, Kerkar P, Guneri S, Sezer M, Ruda M, Nicolau JC, Cavallini C, Ebrahim I, Petrov I, Kim JH, Jeong MH, Ramos Lopez GA, Laanmets P, Kovar F, Gaudin C, Fanouillere KC, Minini P, Hoffman EB, Moryusef A, Wiviott SD, Sabatine MS; TAO Investigators. Anticoagulation with otamixaban and ischemic events in non-ST-segment elevation acute coronary syndromes: the TAO randomized clinical trial. JAMA. 2013 Sep 18;310(11):1145-55. doi: 10.1001/jama.2013.277165.

repository_institution: University of Zurich - Zurich Open Repository and Archive

publisher_dissemination: American Medical Association

ReferenceCitation: Abtan J, Wiviott SD, Sorbets E, Popovic B, Elbez Y, Mehta SR, Sabatine MS, Bode C, Pollack CV, Cohen M, Moccetti T, Laanmets P, Faxon D, Okreglicki A, Ducrocq G, Steg PG; TAO investigators. Prevalence, clinical determinants and prognostic implications of coronary procedural complications of percutaneous coronary intervention in non-ST-segment elevation myocardial infarction: Insights from the contemporary multinational TAO trial. Arch Cardiovasc Dis. 2021 Mar;114(3):187-196. doi: 10.1016/j.acvd.2020.09.005. Epub 2021 Jan 29.

license: publisher-specific-oa

license_normalized: publisher-specific

ReferenceCitation: Dillinger JG, Ducrocq G, Elbez Y, Cohen M, Bode C, Pollack C Jr, Petrauskiene B, Henry P, Dorobantu M, French WJ, Wiviott SD, Sabatine MS, Mehta SR, Steg PG. Sex Differences in Ischemic and Bleeding Outcomes in Patients With Non-ST-Segment-Elevation Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: Insights From the TAO Trial. Circ Cardiovasc Interv. 2021 Jan;14(1):e009759. doi: 10.1161/CIRCINTERVENTIONS.120.009759. Epub 2021 Jan 12.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Dillinger JG, Ducrocq G, Elbez Y, Cohen M, Bode C, Pollack C Jr, Nicolau JC, Henry P, Kedev S, Wiviott SD, Sabatine MS, Mehta SR, Steg PG. Activated Clotting Time to Guide Heparin Dosing in Non-ST-Segment-Elevation Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention and Treated With IIb/IIIa Inhibitors: Impact on Ischemic and Bleeding Outcomes: Insights From the TAO Trial. Circ Cardiovasc Interv. 2018 Jun;11(6):e006084. doi: 10.1161/CIRCINTERVENTIONS.118.006084.

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title: Randomized, Double-blind, Triple-dummy Trial to Compare the Efficacy of Otamixaban With Unfractionated Heparin + Eptifibatide, in Patients With Unstable Angina/Non ST Segment Elevation Myocardial Infarction Scheduled to Undergo an Early Invasive Strategy


title: A Randomised Double-blind Cross-over Patient Preference Study of Pazopanib Versus Sunitinib in Treatment naïve Locally Advanced or Metastatic Renal Cell Carcinoma.

acronym: PISCES

summary: This is a randomised, double-blind, cross-over study of pazopanib versus sunitinib in patients with locally advanced or metastatic renal cell carcinoma (mRCC) who have received no prior systemic therapy for advanced or metastatic RCC. Approximately 160 eligible patients will be stratified based on the ECOG performance status (0 vs. 1) and number of metastatic sites of disease (0 and 1 vs. >=2). The study consists of two treatment periods of 10 weeks with a 2-week wash-out period between the two treatment periods. Patients will receive pazopanib and sunitinib treatment sequentially in a double-blinded fashion. The primary objective of the study is to assess how the tolerability and safety differences between pazopanib and sunitinib translate into patient preference, defined by the patient's stated preference for which drug they may prefer to continue treatment with at end of study. The secondary objectives are to evaluate the reason for patient preference as assessed by a patient preference questionnaire; to evaluate fatigue as assessed by FACIT-Fatigue and quality of life as assessed by EuroQoL EQ-5D; to evaluate dose modifications and time to dose modification; and to evaluate safety.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Oudard S, Benhamouda N, Escudier B, Ravel P, Tran T, Levionnois E, Negrier S, Barthelemy P, Berdah JF, Gross-Goupil M, Sternberg CN, Bono P, Porta C, De Giorgi U, Parikh O, Hawkins R, Highley M, Wilke J, Decker T, Tanchot C, Gey A, Terme M, Tartour E. Decrease of Pro-Angiogenic Monocytes Predicts Clinical Response to Anti-Angiogenic Treatment in Patients with Metastatic Renal Cell Carcinoma. Cells. 2021 Dec 22;11(1):17. doi: 10.3390/cells11010017.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: MDPI

ReferenceCitation: Lai JS, Beaumont JL, Diaz J, Khan S, Cella D. Validation of a short questionnaire to measure symptoms and functional limitations associated with hand-foot syndrome and mucositis in patients with metastatic renal cell carcinoma. Cancer. 2016 Jan 15;122(2):287-95. doi: 10.1002/cncr.29655. Epub 2015 Oct 12.

oa_host_type: publisher

evidence: open (via free article)

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Wiley

ReferenceCitation: Escudier B, Porta C, Bono P, Powles T, Eisen T, Sternberg CN, Gschwend JE, De Giorgi U, Parikh O, Hawkins R, Sevin E, Negrier S, Khan S, Diaz J, Redhu S, Mehmud F, Cella D. Randomized, controlled, double-blind, cross-over trial assessing treatment preference for pazopanib versus sunitinib in patients with metastatic renal cell carcinoma: PISCES Study. J Clin Oncol. 2014 May 10;32(14):1412-8. doi: 10.1200/JCO.2013.50.8267. Epub 2014 Mar 31.

evidence: open (via free pdf)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

lead_sponsor: Novartis Pharmaceuticals

location_country:
Finland
Italy
Germany
United Kingdom
France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: Registry Identifier

type: Other Identifier

title: An Exploratory Trial to Assess Naturalistic Safety and Efficacy Outcomes in Patients With Moderate to Severe Plaque Psoriasis Transitiioned to Ustekinumab From Previous Methotrexate Therapy (TRANSIT)

acronym: TRANSIT

summary: This purpose of this study is to assess the safety of ustekinumab in psoriasis patients who receive ustekinumab following an inadequate response to methotrexate therapy. The study will provide information for doctors on how to manage the transfer from methotrexate to the biologic agent ustekinumab. The study is designed to compare two methods of transferring patients from methotrexate to ustekinumab. The two methods being compared are discontinuation of methotrexate with immediate initiation of ustekinumab versus initiation of ustekinumab with overlap and gradual dose reduction of methotrexate over 4 weeks.

lead_sponsor: Janssen-Cilag International NV

location_country:
Finland
Germany
Poland
France
Lithuania
Portugal
Slovakia
Hungary
Denmark
Belgium
Norway
United Kingdom
Sweden
Netherlands
Austria
Spain
Greece
Bulgaria
Israel


lead_sponsor: Hoffmann-La Roche

summary: This randomized, two-arm study evaluated the efficacy and safety of a combination of trastuzumab and capecitabine with or without pertuzumab in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. The study population consisted of female patients, whose disease had progressed during or following previous trastuzumab therapy for metastatic disease. All patients in Arm A and Arm B received trastuzumab (8 mg/kg iv as loading dose and then 6 mg/kg iv every 3 weeks thereafter) and capecitabine oral twice daily for 14 days every 3 weeks (1250 mg/m2 twice daily in Arm A and 1000 mg/m2 twice daily in Arm B). In addition, patients in Arm B received pertuzumab (840 mg iv as loading dose and then 420 mg iv thereafter) every 3 weeks. Study treatment continued until disease progression or unacceptable toxicity.

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: S.-Peterburg Pavlov State Medical University ; Haematology

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Phramongkutklao Hospital;Dept Surgery/Surgical Oncology Unit

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: Az. Osp. S. Orsola Malpighi; Istituto Di Oncologia Seragnoli

location_facility: Tartu University Hospital; Clinic of Hematology and Oncology

location_facility: Klinikum Frankfurt Höchst GmbH; Klinik für Gynäkologie und Geburtshilfe

location_facility: Fövárosi Önkormányzat Bajcsy-Zsilinszky Kórház; Onkológiai Osztály

location_facility: Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

location_facility: ASST DI CREMONA; Dipartimento Aziendale Oncologico

location_facility: Wojewodzki Sziptal Specjalistyczny Im. Janusza Korczaka; Oddzial Onkologiczny, Oddzial Chemioterapii

location_facility: Kaposi Mor County Hospital; Dept. of Oncology

location_facility: Masarykuv onkologicky ustav; Oncology II

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

location_facility: Municipal Clinical Hospital Filantropia; Oncology

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

location_facility: CHU Henri Mondor; Service d'Oncologie Medicale

location_facility: Centre Henri Becquerel; Oncologie Medicale

location_facility: Ospedale Mater Salutis; Dept of Oncology

location_facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

location_facility: Asst Papa Giovanni XXIII; Oncologia Medica

location_facility: A.Ö. Landesschwerpunktkrankenhaus Krems; Abtl. F. Innere Med.

location_facility: Hospital Ruber Internacional;Servicio de Oncologia

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

location_facility: Istituto Regina Elena; Oncologia Medica A

location_facility: Institut für Versorgungsforschung in der Onkologie GbR Koblenz

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

location_facility: Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology

location_facility: Josa Andras Korhaz; Dept of Oncoradiology

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

location_facility: Klinik Fulda, Medizinisches Versorgungszentrum Osthessen GmbH

location_facility: Queen Elizabeth Hospital; Clinical Oncology

location_facility: Hospital of Aladar Petz; Dept of Oncoradiology

location_facility: Hospital de Sagunto; Servicio de Oncologia

location_facility: Regional Oncology Hospital of Krasnodar; Oncology

location_facility: Klinikum Dortmund gGmbH Klinikzentrum Mitte

location_facility: Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek

location_facility: C.H. Du Pays D'aix En Provence Service du Dr Blanc

location_facility: Complejo Hospitalario Torrecardenas; Servicio de Oncologia

location_facility: St. Vincenz-Elisabeth-Hospital; Katholisches Klinikum Mainz

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

location_facility: Uni Hospital For Tumours; Dept of Medical Oncology

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

location_facility: Hospital Juan Ramon Jimenez;Servicio de Oncologia

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

location_facility: Clinica Anglo Americana - Centro de Investigacion Oncologia CAA

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

location_facility: Ospedale Infermi Di Rimini; Unità Operativa di Oncologia e Oncoematologia

location_facility: Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

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

location_facility: Seoul National University Hosp; Dept Internal Med Hem Onc

location_facility: Ospedale Umberto I ASL di Ravenna Presidio Ospedaliero di Lugo

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

location_facility: Wojewodzki Szpital Zespolony; Oddzial Chemioterapii

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie

location_facility: Royal Bournemouth General Hospital; Oncology

location_facility: Korea University Guro Hospital; Oncology

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Srinagarind Hospital; Department of Surgery

location_facility: Semashko Central Clinical Hospital; Dept of Chemotherapy

location_facility: Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie

location_facility: Spitalul Clinic Sf. Maria; Departmental De Oncologie

location_facility: Songklanagarind Hospital; Department of Surgery

location_facility: Centro Oncológico Estatal; ISSSEMYM Oncología

location_facility: Blokhin Cancer Research Center; Combined Treatment

location_facility: Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology

location_facility: Fundacion Hospital de Alcorcon; Servicio de Oncologia

location_facility: ARNAS-Ospedale Civico Maurizio Ascoli; Unità Operativa di Oncologia Medica

location_facility: Municipal Hospital of Uzsoki Utca; Centre of Oncoradiology

location_facility: Ospedale Cervesi di Cattolica ; Unità Operativa di Oncologia ed Oncoematologia

location_facility: Unidad de Investigacion Oncologia Clinica - Piura; Unidad de Oncología Clínica

location_facility: SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary

location_facility: Great Western Hospital; Clinical Oncology

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

location_facility: CAMPUS CHARITÉ MITTE; Tagesklinik für Onkologie u.Hämatologie

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

location_facility: Fejér Megyei Szent György Kórház; Onkológiai Osztály

location_facility: University Hospital of North Durham; Oncology

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Istituto Tumori Fondazione Pascale; Endocrinologia Oncologica

location_facility: Hospital Clinic i Provincial; Servicio de Farmacia

location_facility: Ramathibodi Hospital; Department of Surgery/Breast and Endocrine Unit

location_facility: Cluj Clinical County Hospital; Oncology Dept

location_facility: Complejo Hospitalario de Pontevedra; Servicio de Oncologia

location_facility: Centre Antoine Lacassagne; Hopital De Jour A2

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

location_facility: Peterborough City Hospital, Edith Cavell Campus; Oncology Department

location_facility: Saint-Petersburg City Clinical Oncology Dispensary

location_facility: Royal Cornwall Hospital; Dept of Clinical Oncology

location_facility: Vu Medisch Centrum; Afdeling Maag-, Darm- En Leverziekte

location_facility: Klinikum rechts der Isar der TU München; Frauenklinik & Poliklinik

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Christie Hospital; Breast Cancer Research Office

location_facility: Oncologia Sul Capixaba Servicos Medicos - Oncosul

location_facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

location_facility: Complejo Asistencial Universitario de Leon; Servicio de Oncologia

location_facility: Hospital de Basurto; Servicio de Oncologia

location_facility: Ausl Ravenna-Osp.Infermi; Day Hospital Oncologia Medica

location_facility: Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika

location_facility: Uni Cattolica Policlinico Gemelli; Oncologia Medica Ist. Medicina Interna

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly

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

location_facility: ViDia Christliche Kliniken Karlsruhe, Vincentius-Diakonissen-Kliniken gAG; Frauenklinik

location_facility: COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej

location_facility: North Estonia Medical Centre Foundation; Oncology Centre

location_facility: Centre Hospitalier Fleyriat; Oncologie/Hematologie

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

location_facility: Institute Of Oncology Bucharest; Medical Oncology

location_facility: Instituto de Investigaciones Clínicas Quilmes

location_facility: Azienda ospedaliero-universitaria careggi, Sezione di radioterapia del dipartimento di fisiopatolo

location_facility: IRCCS Fondazione Maugeri; Oncologia Medica II

location_facility: Institut Jean Godinot; Oncologie Medicale

location_facility: Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

location_facility: Hospital Nacional Edgardo Rebagliati Martins

location_facility: Lekarske Fakulty Univerzity Karlovy Fakultni Nemocnice Na Bulovce; Ustav Radiacni Onkologie

location_facility: University Hospital; Oncology and Radiotherapy

location_facility: Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny

location_facility: Klinikum Bremen-Mitte gGmbH; Frauenklinik

location_facility: Fundacion Jimenez Diaz; Servicio de Oncologia

location_facility: Pécsi Tudományegyetem Áok; Onkoterapias Intezet

location_facility: Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

location_facility: Centre Rene Huguenin; CONSULT SPECIALISEES

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Hopital Hautepierre; Hematologie Oncologie

location_facility: Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe

title: A Multicenter Randomized Phase III Study to Compare the Combination Trastuzumab and Capecitabine, With or Without Pertuzumab, in Patients With HER2-Positive Metastatic Breast Cancer That Have Progressed After One Line of Trastuzumab-Based Therapy in the Metastatic Setting (PHEREXA)

type: EudraCT Number

source: euctr

location_country:
Germany
Poland
Argentina
Brazil
Thailand
Croatia
Czechia
Canada
France
Hungary
Hong Kong
Romania
Belgium
Peru
Estonia
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Russian Federation


acronym: Triptocare

lead_sponsor: Ipsen

summary: The purpose of this study is to evaluate the effect of an initial hormonal treatment gonadotrophin-releasing hormone (GnRH Agonist) on 2 biomarkers (PCA3 and TMPRSS2-ERG), in patients with histologically confirmed and advanced stages of prostate cancer. Their characteristics, according to risk factors such as PSA and Gleason score will be determined at baseline and 1, 3 and 6 month post-treatment.

location_facility: IRCCS Fondazione S. Raffaele del Monte Tabor

title: Prostate Cancer Antigen-3 (PCA-3) and TMPRSS2-ERG (T2-ERG) Score Changes During Initiation of Androgen Deprivation Therapy (ADT) With Triptorelin 22.5mg in Patients With Advanced Prostate Cancer (PCA): A Phase III, Single Arm Multicentre Study

primary_purpose: Diagnostic

location_country:
Italy
Lithuania
United Kingdom
Denmark
Romania
Netherlands
Belgium
Latvia
Spain
France


title: A Randomized, Double-blind, Parallel Group, Placebo Controlled, Multi-center Study of Fixed Dose Combinations of Solifenacin Succinate (6 mg and 9 mg) With Tamsulosin Hydrochloride OCAS 0.4 mg and Tamsulosin Hydrochloride OCAS 0.4 mg Monotherapy, in Male Subjects With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) With a Substantial Storage Component

acronym: Neptune

summary: Clinical study to examine the efficacy, safety and tolerability of combination therapy of tamsulosin hydrochloride and solifenacin succinate compared to monotherapy of tamsulosin hydrochloride in the treatment of males with LUTS associated with BPH with a substantial storage component.

ReferenceType: background

ReferenceCitation: van Kerrebroeck P, Chapple C, Drogendijk T, Klaver M, Sokol R, Speakman M, Traudtner K, Drake MJ; NEPTUNE Study Group. Combination therapy with solifenacin and tamsulosin oral controlled absorption system in a single tablet for lower urinary tract symptoms in men: efficacy and safety results from the randomised controlled NEPTUNE trial. Eur Urol. 2013 Dec;64(6):1003-12. doi: 10.1016/j.eururo.2013.07.034. Epub 2013 Aug 3.

ipd_sharing: Yes

ipd_sharing_description: Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Europe B.V.

location_country:
Germany
Belarus
Italy
Poland
Slovakia
Hungary
United Kingdom
Netherlands
Austria
Belgium
Czech Republic
Russian Federation
France


acronym: ACE

lead_sponsor: Daiichi Sankyo, Inc.

summary: AC220 will be administered as a once daily oral solution given continuously as 28-day treatment cycles, without any rest periods, until disease progression, relapse, intolerance to the drug, or elective allogeneic hematopoietic stem cell transplantation (HSCT).

ReferenceCitation: Cortes J, Perl AE, Dohner H, Kantarjian H, Martinelli G, Kovacsovics T, Rousselot P, Steffen B, Dombret H, Estey E, Strickland S, Altman JK, Baldus CD, Burnett A, Kramer A, Russell N, Shah NP, Smith CC, Wang ES, Ifrah N, Gammon G, Trone D, Lazzaretto D, Levis M. Quizartinib, an FLT3 inhibitor, as monotherapy in patients with relapsed or refractory acute myeloid leukaemia: an open-label, multicentre, single-arm, phase 2 trial. Lancet Oncol. 2018 Jul;19(7):889-903. doi: 10.1016/S1470-2045(18)30240-7. Epub 2018 May 31.

oa_host_type: repository

version: acceptedVersion

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

repository_institution: California Digital Library - eScholarship

version: submittedVersion

repositories_concat: PubMed Central;escholarship.org

unpaywall_oa_status: green

publisher_dissemination: Elsevier

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Uniklinik Essen, Westdeutsches Tumorzentrum

location_facility: Hospital Universitario de Salamanca, Hospital Clinico, Servicio de Hematologia

location_facility: Universita Degli Studi di Roma Tor Vergata

location_facility: Centre Hospitalier Universitaire Grenoble

location_facility: Utrecht University Medical Centre, Dept. of Hematology

location_facility: Instituto Catalan de Oncologia-Hospital Universitari de Girona

location_facility: Institut Catala d'Oncologia del Hospital Universitari Germans

location_facility: Universitatsklinikum Leipzig Selbstandige Abteilung fur Hamatologie

location_facility: Centre Hospitalier Universitaire Limoges

location_facility: Centre Henry Becquerel, Service d'Hematologie

location_facility: Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine, Clinica Ematologica

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Azienda Ospedaliera-Universitaria Vittorio Emanuele-Ferrarotto

location_facility: Saint James University Hospital, Institute of Oncology

location_facility: Unita Trapianti di Midollo Osseo per Adulti

location_facility: Dolnoslaskie Centrum Transplantacji Komorkowych z

location_facility: Centre Hospitalier Regional Universitaire, Hopital de Hautepierre

location_facility: Universitatsklinikum Regensburg Abteilung fur Hamatologie

location_facility: Klinikum der Johann Wolfgang Goethe Universitat

location_facility: Presidio Ospedaliero "A. Businco" - Centro di Riferimento Oncologico Regionale

location_facility: Centre Hospitalier Universitaire Brabois

location_facility: Hospital de la Princesa, Servicio de Hematologia

location_facility: Hanmmersmith Hospital, Dept. of Hematology

location_facility: Instituto Di Ematologia "L.Ea. Seragnoli"

location_facility: University of Iowa Hospitals and Clinics

location_facility: Institut Paoli Calmettes Centre Regional de Lutte Contre le Cancer

location_facility: Klinikum rechts der Isar, Technische Universitat Munchen

location_facility: Azienda Ospedaliero Universitaria Senese

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Centre Hospitalier Universitaire d'Angers

title: Phase 2 Open-Label, AC220 Monotherapy Efficacy (ACE) Study in Patients With Acute Myeloid Leukemia (AML) With and Without FLT3-ITD Activating Mutations

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

design_allocation: Non-Randomized

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


title: Add-on Study of Hydrochlorothiazide in Patients With Moderate to Severe Hypertension Not Achieving Target Blood Pressure on Olmesartan/Amlodipine Alone

summary:
Both Olmesartan (OLM)/Amlodipine (AML) combination and Hydrochlorothiazide (HCTZ) have proven to be efficacious and safe in lowering blood pressure, but may not always be sufficient. This study is to test efficacy and safety of the combination of OLM/AML and HCTZ in hypertensive patients whose blood pressure is not adequately controlled with OLM/AML alone. The following treatments will be included in the trial: OLM 40mg/AML 10mg; OLM 40mg/AML 10 mg/HCTZ 12.5 mg; OLM 40 mg/AML 10 mg/HCTZ 25 mg. The trial has four periods. The treatments that will be used are as follows:

Period 1 - OLM 40mg/AML 10mg; Period 2 - OLM 40mg/AML 10mg or OLM 40mg/AML 10 mg/HCTZ 12.5 mg or OLM 40 mg/AML 10 mg/HCTZ 25 mg; Period 3 - OLM 40mg/AML 10 mg/HCTZ 12.5 mg; Period 4 - Period 3 responders: OLM 40mg/AML 10 mg/HCTZ 12.5 mg; Period 4 - Period 3 non-responders: OLM 40mg/AML 10 mg/HCTZ 12.5 mg or OLM 40 mg/AML 10 mg/HCTZ 25 mg

location_country:
Germany
Poland
Slovakia
Denmark
Romania
Netherlands
Austria
Belgium
Spain
Czechia
Bulgaria
Ukraine
Russian Federation
France


summary: This study is designed to assess the safety and efficacy of RAD001 monotherapy in patients with advanced gastric cancer which has progressed after one or two lines of prior chemotherapy.

ReferenceCitation: Ohtsu A, Ajani JA, Bai YX, Bang YJ, Chung HC, Pan HM, Sahmoud T, Shen L, Yeh KH, Chin K, Muro K, Kim YH, Ferry D, Tebbutt NC, Al-Batran SE, Smith H, Costantini C, Rizvi S, Lebwohl D, Van Cutsem E. Everolimus for previously treated advanced gastric cancer: results of the randomized, double-blind, phase III GRANITE-1 study. J Clin Oncol. 2013 Nov 1;31(31):3935-43. doi: 10.1200/JCO.2012.48.3552. Epub 2013 Sep 16.

oa_colors: green other

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

repository_institution: PubMed Central - Europe PMC

location_facility: University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(4)

location_facility: University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology

location_facility: University of Washington Cancer Care Seattle Cancer Alliance

location_facility: Highlands Oncology Group DeptofHighlandsOncologyGrp(2)

location_facility: Loma Linda Oncology Medical Group Loma Linda

location_facility: Henry Ford Hospital Dept. of Henry Ford Hospital

location_facility: The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD(2)

title: A Randomized, Double-blind, Multi-center Phase III Study Comparing Everolimus (RAD001) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Patients With Advanced Gastric Cancer After Progression on 1 or 2 Prior Systemic Chemotherapy

location_country:
Germany
New Zealand
Argentina
Australia
Japan
Thailand
Canada
France
Hong Kong
United States
Belgium
China
Peru
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel


summary: This open label study was designed to evaluate Lapatinib effect on incidence of brain metastases in ErbB2 (HER2) positive metastatic breast cancer patients exposed to prior taxanes or anthracyclines.

ReferenceCitation: Pivot X, Manikhas A, Zurawski B, Chmielowska E, Karaszewska B, Allerton R, Chan S, Fabi A, Bidoli P, Gori S, Ciruelos E, Dank M, Hornyak L, Margolin S, Nusch A, Parikh R, Nagi F, DeSilvio M, Santillana S, Swaby RF, Semiglazov V. CEREBEL (EGF111438): A Phase III, Randomized, Open-Label Study of Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in Patients With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer. J Clin Oncol. 2015 May 10;33(14):1564-73. doi: 10.1200/JCO.2014.57.1794. Epub 2015 Jan 20.

title: A Randomized, Multicentre, Open-Label, Phase III Study of Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in Patients With Anthracycline- or Taxane-Exposed ErbB2-Positive Metastatic Breast Cancer

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

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Denmark
Sweden
Belgium
United States
Spain
Thailand
Greece
Russian Federation
France

ipd_sharing: Undecided


title: Randomized Placebo-controlled Study of Two Treatment Strategies Based on Tocilizumab (TCZ) With or Without Methotrexate (MTX) and Possible Addition of Other Disease-modifying Anti-rheumatic Drugs (DMARDs) in Patients...

summary: This 2 arm study will compare 2 treatment strategies based on tocilizumab in combination with methotrexate or placebo in patients with moderate to severe rheumatoid arthritis. Patients receiving methotrexate treatment will be randomized to receive either a) tocilizumab 8 mg intravenous (iv) every 4 weeks + methotrexate orally (po) weekly or b) tocilizumab 8 mg iv every 4 weeks + placebo po weekly. After the first 24 weeks of blinded treatment, treatment adjustments (increase or decrease of treatment intensity) may be introduced at intervals, based on response. The anticipated time on study treatment is up to 3 years, and the target sample size is approximately 470 patients.

ReferenceType: result

ReferenceCitation: Dougados M, Kissel K, Sheeran T, Tak PP, Conaghan PG, Mola EM, Schett G, Amital H, Navarro-Sarabia F, Hou A, Bernasconi C, Huizinga TW. Adding tocilizumab or switching to tocilizumab monotherapy in methotrexate inadequate responders: 24-week symptomatic and structural results of a 2-year randomised controlled strategy trial in rheumatoid arthritis (ACT-RAY). Ann Rheum Dis. 2013 Jan;72(1):43-50. doi: 10.1136/annrheumdis-2011-201282. Epub 2012 May 5.

ReferenceCitation: Dougados M, Kissel K, Conaghan PG, Mola EM, Schett G, Gerli R, Hansen MS, Amital H, Xavier RM, Troum O, Bernasconi C, Huizinga TW. Clinical, radiographic and immunogenic effects after 1 year of tocilizumab-based treatment strategies in rheumatoid arthritis: the ACT-RAY study. Ann Rheum Dis. 2014 May;73(5):803-9. doi: 10.1136/annrheumdis-2013-204761. Epub 2014 Jan 28.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: University of Bern - Bern Open Repository and Information System

repository_institution: Kooperativer Bibliotheksverbund Berlin-Brandenburg (KOBV), on behalf of the Universitätsbibliothek Erlangen-Nürnberg - OPUS FAU - Online-Publikationssystem der Friedrich-Alexander-Universität Erlangen-Nürnberg

repository_institution: University of Oxford - Oxford Academic Notes & Queries

unpaywall_oa_status: hybrid

publisher_dissemination: British Medical Journal

ReferenceCitation: Dougados M, Huizinga TW, Choy EH, Bingham CO 3rd, Aassi M, Bernasconi C. Evaluation of the Disease Activity Score in Twenty-Eight Joints-Based Flare Definitions in Rheumatoid Arthritis: Data From a Three-Year Clinical Trial. Arthritis Care Res (Hoboken). 2015 Dec;67(12):1762-6. doi: 10.1002/acr.22633.

evidence: open (via crossref license)

repositories_concat: PubMed Central;boris.unibe.ch

ReferenceCitation: Huizinga TW, Conaghan PG, Martin-Mola E, Schett G, Amital H, Xavier RM, Troum O, Aassi M, Bernasconi C, Dougados M. Clinical and radiographic outcomes at 2 years and the effect of tocilizumab discontinuation following sustained remission in the second and third year of the ACT-RAY study. Ann Rheum Dis. 2015 Jan;74(1):35-43. doi: 10.1136/annrheumdis-2014-205752. Epub 2014 Aug 28.

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

repository_normalized: dnet

location_country:
Germany
Brazil
Thailand
Croatia
Serbia
France
Denmark
United States
Latvia
Romania
Estonia
Italy
Norway
United Kingdom
Sweden
Netherlands
Spain
Greece
Russian Federation
Israel


title: A Multicenter, Randomized, Open-label, Active-controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin-naïve Type 2 Diabetic Patients Inadequately Controlled With Metformin and Sulphonylurea Combination Therapy

summary: This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared to insulin glargine in patients with insulin-naive type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea combination therapy. Patients will be randomized to receive taspoglutide (10 mg once weekly, or 10mg once weekly for 4 weeks followed by 20mg once weekly) or insulin glargine (starting dose 10 IU/day) in a ratio of 1:1:1 in addition to continued prestudy metformin treatment. The anticipated time on study treatment is 2+ years, and the target sample size if 500+ individuals.

ReferenceCitation: Nauck M, Horton E, Andjelkovic M, Ampudia-Blasco FJ, Parusel CT, Boldrin M, Balena R; T-emerge 5 Study Group. Taspoglutide, a once-weekly glucagon-like peptide 1 analogue, vs. insulin glargine titrated to target in patients with Type 2 diabetes: an open-label randomized trial. Diabet Med. 2013 Jan;30(1):109-13. doi: 10.1111/dme.12003.

location_country:
Finland
Germany
Poland
New Zealand
Australia
Brazil
Thailand
Canada
Serbia
France
Czech Republic
Portugal
Hungary
Hong Kong
United States
Belgium
Peru
Puerto Rico
Italy
Guatemala
United Kingdom
Austria
Mexico
Korea, Republic of
Spain
Greece
Russian Federation


title: An International Randomised Controlled Trial to Establish the Effects of Early Intensive Blood Pressure Lowering in Patients With Intracerebral Haemorrhage.

summary: The purpose of this academic lead study is to determine if a treatment strategy of early intensive blood pressure (BP) lowering compared to conservative BP lowering policy in patients with elevated blood pressure within 6 hours of acute intracerebral haemorrhage (ICH) improves the outcome of death and disability at 3 months after onset.

ReferenceCitation: Anderson CS, Huang Y, Wang JG, Arima H, Neal B, Peng B, Heeley E, Skulina C, Parsons MW, Kim JS, Tao QL, Li YC, Jiang JD, Tai LW, Zhang JL, Xu E, Cheng Y, Heritier S, Morgenstern LB, Chalmers J; INTERACT Investigators. Intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT): a randomised pilot trial. Lancet Neurol. 2008 May;7(5):391-9. doi: 10.1016/S1474-4422(08)70069-3. Epub 2008 Apr 7.

ReferenceCitation: Delcourt C, Huang Y, Wang J, Heeley E, Lindley R, Stapf C, Tzourio C, Arima H, Parsons M, Sun J, Neal B, Chalmers J, Anderson C; INTERACT2 Investigators. The second (main) phase of an open, randomised, multicentre study to investigate the effectiveness of an intensive blood pressure reduction in acute cerebral haemorrhage trial (INTERACT2). Int J Stroke. 2010 Apr;5(2):110-6. doi: 10.1111/j.1747-4949.2010.00415.x.

ReferenceCitation: Malavera A, You S, Zheng D, Delcourt C, Anderson CS; INTERACT2 Investigators. Prognostic significance of early pyrexia in acute intracerebral haemorrhage: The INTERACT2 study. J Neurol Sci. 2021 Apr 15;423:117364. doi: 10.1016/j.jns.2021.117364. Epub 2021 Feb 26.

oa_host_type: closed

ReferenceCitation: Sandset EC, Wang X, Carcel C, Sato S, Delcourt C, Arima H, Stapf C, Robinson T, Lavados P, Chalmers J, Woodward M, Anderson CS. Sex differences in treatment, radiological features and outcome after intracerebral haemorrhage: Pooled analysis of Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage trials 1 and 2. Eur Stroke J. 2020 Dec;5(4):345-350. doi: 10.1177/2396987320957513. Epub 2020 Sep 20.

publisher_dissemination: SAGE Publications

ReferenceCitation: Song L, Wang X, Ouyang M, Sun L, Chen X, Arima H, Sandset EC, Delcourt C, Wang J, Chen G, Robinson T, Lindley RI, Chalmers J, Anderson CS; INTERACT2 Investigators. Associations of an Abnormal Physiological Score With Outcomes in Acute Intracerebral Hemorrhage: INTERACT2 Study. Stroke. 2021 Jan;52(2):722-725. doi: 10.1161/STROKEAHA.120.030435. Epub 2021 Jan 11.

ReferenceCitation: Wang X, Moullaali TJ, Li Q, Berge E, Robinson TG, Lindley R, Zheng D, Delcourt C, Arima H, Song L, Chen X, Yang J, Chalmers J, Anderson CS, Sandset EC. Utility-Weighted Modified Rankin Scale Scores for the Assessment of Stroke Outcome: Pooled Analysis of 20 000+ Patients. Stroke. 2020 Aug;51(8):2411-2417. doi: 10.1161/STROKEAHA.119.028523. Epub 2020 Jul 9.

repository_institution: University of Edinburgh - Edinburgh Research Explorer

ReferenceCitation: You S, Zheng D, Delcourt C, Sato S, Cao Y, Zhang S, Yang J, Wang X, Lindley RI, Robinson T, Anderson CS, Chalmers J. Determinants of Early Versus Delayed Neurological Deterioration in Intracerebral Hemorrhage. Stroke. 2019 Jun;50(6):1409-1414. doi: 10.1161/STROKEAHA.118.024403. Epub 2019 Apr 18.

ReferenceCitation: Wang X, Sandset EC, Moullaali TJ, Chen G, Song L, Carcel C, Delcourt C, Woodward M, Robinson T, Chalmers J, Arima H, Anderson CS; INTERACT2 Investigators. Determinants of the high admission blood pressure in mild-to-moderate acute intracerebral hemorrhage. J Hypertens. 2019 Jul;37(7):1463-1466. doi: 10.1097/HJH.0000000000002056.

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

ReferenceCitation: Chen R, Wang X, Anderson CS, Robinson T, Lavados PM, Lindley RI, Chalmers J, Delcourt C. Infratentorial Intracerebral Hemorrhage. Stroke. 2019 May;50(5):1257-1259. doi: 10.1161/STROKEAHA.118.023766.

ReferenceCitation: Moullaali TJ, Wang X, Martin RH, Shipes VB, Qureshi AI, Anderson CS, Palesch YY. Statistical analysis plan for pooled individual patient data from two landmark randomized trials (INTERACT2 and ATACH-II) of intensive blood pressure lowering treatment in acute intracerebral hemorrhage. Int J Stroke. 2019 Apr;14(3):321-328. doi: 10.1177/1747493018813695. Epub 2018 Nov 12.

ReferenceCitation: Delcourt C, Sato S, Zhang S, Sandset EC, Zheng D, Chen X, Hackett ML, Arima H, Hata J, Heeley E, Al-Shahi Salman R, Robinson T, Davies L, Lavados PM, Lindley RI, Stapf C, Chalmers J, Anderson CS; INTERACT2 Investigators. Intracerebral hemorrhage location and outcome among INTERACT2 participants. Neurology. 2017 Apr 11;88(15):1408-1414. doi: 10.1212/WNL.0000000000003771. Epub 2017 Feb 24.

repository_institution: University of Melbourne - Minerva Access

repository_normalized: University of Melbourne - Minerva Access

repository_institution: University of Leicester - Leicester Research Archive

repository_institution: University of Central Lancashire - CLOK - Central Lancashire Online Knowledge

repositories: University of Melbourne - Minerva Access

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;clok.uclan.ac.uk;iris.uniroma1.it;lra.le.ac.uk;pure.ed.ac.uk;repository.ubn.ru.nl

repositories_institution: University of Leicester - Leicester Research Archive

repositories_institution: University of Melbourne - Minerva Access

ReferenceCitation: Delcourt C, Zheng D, Chen X, Hackett M, Arima H, Hata J, Heeley E, Al-Shahi Salman R, Woodward M, Huang Y, Robinson T, Lavados PM, Lindley RI, Stapf C, Davies L, Chalmers J, Anderson CS, Sato S; INTERACT Investigators. Associations with health-related quality of life after intracerebral haemorrhage: pooled analysis of INTERACT studies. J Neurol Neurosurg Psychiatry. 2017 Jan;88(1):70-75. doi: 10.1136/jnnp-2016-314414. Epub 2016 Oct 21.

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

repositories_institution: La Trobe University - OPAL (Open@LaTrobe)

ReferenceCitation: Munoz Venturelli P, Wang X, Zahuranec DB, Lavados PM, Stapf C, Lindley R, Delcourt C, Chalmers J, Anderson CS, Robinson TG, Robinson TG; INTERACT2 Investigators. Withdrawal of active treatment after intracerebral haemorrhage in the INTERACT2 study. Age Ageing. 2017 Mar 1;46(2):329-332. doi: 10.1093/ageing/afw187.

ReferenceCitation: Song L, Sandset EC, Arima H, Heeley E, Delcourt C, Chen G, Yang J, Wu G, Wang X, Lavados PM, Huang Y, Stapf C, Wang J, Robinson TG, Chalmers J, Lindley RI, Anderson CS; INTERACT2 Investigators. Early blood pressure lowering in patients with intracerebral haemorrhage and prior use of antithrombotic agents: pooled analysis of the INTERACT studies. J Neurol Neurosurg Psychiatry. 2016 Dec;87(12):1330-1335. doi: 10.1136/jnnp-2016-313246. Epub 2016 May 13.

ReferenceCitation: Qiu M, Sato S, Zheng D, Wang X, Carcel C, Hirakawa Y, Sandset EC, Delcourt C, Arima H, Wang J, Chalmers J, Anderson CS; INTERACT Investigators*. Admission Heart Rate Predicts Poor Outcomes in Acute Intracerebral Hemorrhage: The Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial Studies. Stroke. 2016 Jun;47(6):1479-85. doi: 10.1161/STROKEAHA.115.012382. Epub 2016 May 10.

ReferenceCitation: Carcel C, Wang X, Sato S, Stapf C, Sandset EC, Delcourt C, Arima H, Robinson T, Lavados P, Chalmers J, Anderson CS; INTERACT2 Investigators*. Degree and Timing of Intensive Blood Pressure Lowering on Hematoma Growth in Intracerebral Hemorrhage: Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial-2 Results. Stroke. 2016 Jun;47(6):1651-3. doi: 10.1161/STROKEAHA.116.013326. Epub 2016 May 3.

ReferenceCitation: Delcourt C, Zhang S, Arima H, Sato S, Al-Shahi Salman R, Wang X, Davies L, Stapf C, Robinson T, Lavados PM, Chalmers J, Heeley E, Liu M, Lindley RI, Anderson CS; INTERACT2 investigators. Significance of Hematoma Shape and Density in Intracerebral Hemorrhage: The Intensive Blood Pressure Reduction in Acute Intracerebral Hemorrhage Trial Study. Stroke. 2016 May;47(5):1227-32. doi: 10.1161/STROKEAHA.116.012921. Epub 2016 Apr 12.

ReferenceCitation: Munoz-Venturelli P, Wang X, Lavados PM, Stapf C, Robinson T, Lindley R, Heeley E, Delcourt C, Chalmers J, Anderson CS; INTERACT2 Investigators. Prophylactic heparin in acute intracerebral hemorrhage: a propensity score-matched analysis of the INTERACT2 study. Int J Stroke. 2016 Jul;11(5):549-56. doi: 10.1177/1747493016641113. Epub 2016 Mar 23.

ReferenceCitation: Zheng D, Arima H, Sato S, Gasparrini A, Heeley E, Delcourt C, Lo S, Huang Y, Wang J, Stapf C, Robinson T, Lavados P, Chalmers J, Anderson CS; INTERACT2 investigators. Low Ambient Temperature and Intracerebral Hemorrhage: The INTERACT2 Study. PLoS One. 2016 Feb 9;11(2):e0149040. doi: 10.1371/journal.pone.0149040. eCollection 2016.

repository_institution: Monash University - Monash University Research Portal

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repository_institution: University of Illinois at Chicago - INDIGO

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;figshare.com;lra.le.ac.uk;monash.edu;repository.ubn.ru.nl;researchonline.lshtm.ac.uk

repositories_institution: University of Illinois at Chicago - INDIGO

ReferenceCitation: Sato S, Delcourt C, Heeley E, Arima H, Zhang S, Al-Shahi Salman R, Stapf C, Woo D, Flaherty ML, Vagal A, Levi C, Davies L, Wang J, Robinson T, Lavados PM, Lindley RI, Chalmers J, Anderson CS; INTERACT2 Investigators. Significance of Cerebral Small-Vessel Disease in Acute Intracerebral Hemorrhage. Stroke. 2016 Mar;47(3):701-7. doi: 10.1161/STROKEAHA.115.012147. Epub 2016 Feb 4.

ReferenceCitation: Saxena A, Anderson CS, Wang X, Sato S, Arima H, Chan E, Munoz-Venturelli P, Delcourt C, Robinson T, Stapf C, Lavados PM, Wang J, Neal B, Chalmers J, Heeley E; INTERACT2 Investigators. Prognostic Significance of Hyperglycemia in Acute Intracerebral Hemorrhage: The INTERACT2 Study. Stroke. 2016 Mar;47(3):682-8. doi: 10.1161/STROKEAHA.115.011627. Epub 2016 Jan 26.

ReferenceCitation: Yu S, Arima H, Heeley E, Delcourt C, Krause M, Peng B, Yang J, Wu G, Chen X, Chalmers J, Anderson CS; INTERACT2 Investigators. White blood cell count and clinical outcomes after intracerebral hemorrhage: The INTERACT2 trial. J Neurol Sci. 2016 Feb 15;361:112-6. doi: 10.1016/j.jns.2015.12.033. Epub 2015 Dec 22.

ReferenceCitation: Moullaali TJ, Sato S, Wang X, Rabinstein AA, Arima H, Carcel C, Chen G, Robinson T, Heeley E, Chan E, Delcourt C, Stapf C, Cordonnier C, Lindley RI, Chalmers J, Anderson CS; INTERACT Investigators. Prognostic significance of delayed intraventricular haemorrhage in the INTERACT studies. J Neurol Neurosurg Psychiatry. 2017 Jan;88(1):19-24. doi: 10.1136/jnnp-2015-311562. Epub 2016 Jan 8.

ReferenceCitation: Wang X, Arima H, Yang J, Zhang S, Wu G, Woodward M, Munoz-Venturelli P, Lavados PM, Stapf C, Robinson T, Heeley E, Delcourt C, Lindley RI, Parsons M, Chalmers J, Anderson CS; INTERACT2 Investigators. Mannitol and Outcome in Intracerebral Hemorrhage: Propensity Score and Multivariable Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial 2 Results. Stroke. 2015 Oct;46(10):2762-7. doi: 10.1161/STROKEAHA.115.009357. Epub 2015 Aug 11.

ReferenceCitation: Sato S, Arima H, Heeley E, Hirakawa Y, Delcourt C, Lindley RI, Robinson T, Huang Y, Morgenstern L, Stapf C, Wang J, Chalmers J, Anderson CS; INTERACT2 Investigators. Off-Hour Admission and Outcomes in Patients with Acute Intracerebral Hemorrhage in the INTERACT2 Trial. Cerebrovasc Dis. 2015;40(3-4):114-20. doi: 10.1159/000434690. Epub 2015 Jul 18.

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

ReferenceCitation: Heeley E, Anderson CS, Woodward M, Arima H, Robinson T, Stapf C, Parsons M, Lavados PM, Huang Y, Wang Y, Crozier S, Parry-Jones A, Wang J, Chalmers J; INTERACT2 Investigators. Poor utility of grading scales in acute intracerebral hemorrhage: results from the INTERACT2 trial. Int J Stroke. 2015 Oct;10(7):1101-7. doi: 10.1111/ijs.12518. Epub 2015 Jun 4.

ReferenceCitation: Wang X, Arima H, Al-Shahi Salman R, Woodward M, Heeley E, Stapf C, Lavados PM, Robinson T, Huang Y, Wang J, Delcourt C, Anderson CS. Rapid Blood Pressure Lowering According to Recovery at Different Time Intervals after Acute Intracerebral Hemorrhage: Pooled Analysis of the INTERACT Studies. Cerebrovasc Dis. 2015;39(3-4):242-8. doi: 10.1159/000381107. Epub 2015 Mar 25.

ReferenceCitation: Wang X, Arima H, Heeley E, Delcourt C, Huang Y, Wang J, Stapf C, Robinson T, Woodward M, Chalmers J, Anderson CS; INTERACT2 Investigators. Magnitude of blood pressure reduction and clinical outcomes in acute intracerebral hemorrhage: intensive blood pressure reduction in acute cerebral hemorrhage trial study. Hypertension. 2015 May;65(5):1026-32. doi: 10.1161/HYPERTENSIONAHA.114.05044. Epub 2015 Mar 23.

ReferenceCitation: Yang J, Arima H, Wu G, Heeley E, Delcourt C, Zhou J, Chen G, Wang X, Zhang S, Yu S, Chalmers J, Anderson CS; INTERACT Investigators. Prognostic significance of perihematomal edema in acute intracerebral hemorrhage: pooled analysis from the intensive blood pressure reduction in acute cerebral hemorrhage trial studies. Stroke. 2015 Apr;46(4):1009-13. doi: 10.1161/STROKEAHA.114.007154. Epub 2015 Feb 24.

ReferenceCitation: Chan E, Anderson CS, Wang X, Arima H, Saxena A, Moullaali TJ, Heeley E, Delcourt C, Wu G, Wang J, Chen G, Lavados PM, Stapf C, Robinson T, Chalmers J, Huang Y; INTERACT2 Investigators. Significance of intraventricular hemorrhage in acute intracerebral hemorrhage: intensive blood pressure reduction in acute cerebral hemorrhage trial results. Stroke. 2015 Mar;46(3):653-8. doi: 10.1161/STROKEAHA.114.008470. Epub 2015 Feb 12.

ReferenceCitation: Priglinger M, Arima H, Anderson C, Krause M; INTERACT Investigators. No relationship of lipid-lowering agents to hematoma growth: pooled analysis of the intensive blood pressure reduction in acute cerebral hemorrhage trials studies. Stroke. 2015 Mar;46(3):857-9. doi: 10.1161/STROKEAHA.114.007664. Epub 2015 Feb 5.

ReferenceCitation: Sato S, Heeley E, Arima H, Delcourt C, Hirakawa Y, Pamidimukkala V, Li Z, Tao Q, Xu Y, Hennerici MG, Robinson T, Tzourio C, Lindley RI, Chalmers J, Anderson CS; INTERACT Investigators; Anderson CS, Huang Y, Wang JG, Arima H, Neal B, Peng B, Heeley E, Skulina C, Parsons MW, Kim JS, Tao QL, Li YC, Jiang JD, Tai LW, Zhang LJ, Xu E, Cheng Y, Heritier S, Morgenstern LB, Chalmers J. Higher mortality in patients with right hemispheric intracerebral haemorrhage: INTERACT1 and 2. J Neurol Neurosurg Psychiatry. 2015 Dec;86(12):1319-23. doi: 10.1136/jnnp-2014-309870. Epub 2015 Jan 14.

ReferenceCitation: Wang X, Arima H, Al-Shahi Salman R, Woodward M, Heeley E, Stapf C, Lavados PM, Robinson T, Huang Y, Wang J, Delcourt C, Anderson CS; INTERACT Investigators. Clinical prediction algorithm (BRAIN) to determine risk of hematoma growth in acute intracerebral hemorrhage. Stroke. 2015 Feb;46(2):376-81. doi: 10.1161/STROKEAHA.114.006910. Epub 2014 Dec 11.

ReferenceCitation: Radholm K, Arima H, Lindley RI, Wang J, Tzourio C, Robinson T, Heeley E, Anderson CS, Chalmers J; INTERACT2 Investigators. Older age is a strong predictor for poor outcome in intracerebral haemorrhage: the INTERACT2 study. Age Ageing. 2015 May;44(3):422-7. doi: 10.1093/ageing/afu198. Epub 2014 Dec 13.

ReferenceCitation: Manning L, Hirakawa Y, Arima H, Wang X, Chalmers J, Wang J, Lindley R, Heeley E, Delcourt C, Neal B, Lavados P, Davis SM, Tzourio C, Huang Y, Stapf C, Woodward M, Rothwell PM, Robinson TG, Anderson CS; INTERACT2 investigators. Blood pressure variability and outcome after acute intracerebral haemorrhage: a post-hoc analysis of INTERACT2, a randomised controlled trial. Lancet Neurol. 2014 Apr;13(4):364-73. doi: 10.1016/S1474-4422(14)70018-3. Epub 2014 Feb 13.

ReferenceCitation: Chen G, Arima H, Wu G, Heeley E, Delcourt C, Zhang P, Rabinstein AA, Robinson T, Stapf C, Huang Y, Song L, Yang J, Wang X, Li Q, Chen X, Chalmers J, Anderson C; INTERACT2 Investigators. Subarachnoid extension of intracerebral hemorrhage and 90-day outcomes in INTERACT2. Stroke. 2014 Jan;45(1):258-60. doi: 10.1161/STROKEAHA.113.003524. Epub 2013 Oct 22.

ReferenceCitation: Anderson CS, Heeley E, Huang Y, Wang J, Stapf C, Delcourt C, Lindley R, Robinson T, Lavados P, Neal B, Hata J, Arima H, Parsons M, Li Y, Wang J, Heritier S, Li Q, Woodward M, Simes RJ, Davis SM, Chalmers J; INTERACT2 Investigators. Rapid blood-pressure lowering in patients with acute intracerebral hemorrhage. N Engl J Med. 2013 Jun 20;368(25):2355-65. doi: 10.1056/NEJMoa1214609. Epub 2013 May 29.

repository_institution: The University of Sydney - The Sydney eScholarship Repository

repository_institution: University of Newcastle, Australia - NOVA

repository_institution: UWA - UWA Profiles and Research Repository

repositories_institution: UWA - UWA Profiles and Research Repository

repositories_institution: University of Newcastle, Australia - NOVA

ReferenceCitation: Delcourt C, Stapf C, Tzourio C, Heritier S, Anderson C. [The second (main) phase of an open, randomised, multicentre study to investigate the effectiveness of an INTEnsive blood pressure Reduction in Acute Cerebral hemorrhage Trial (INTERACT2): protocol and baseline characteristics of patients included in France]. Rev Neurol (Paris). 2012 Apr;168(4):321-7. doi: 10.1016/j.neurol.2011.08.010. Epub 2011 Nov 29. French.

collaborators: National Health and Medical Research Council, Australia

location_country:
Finland
Germany
Argentina
Australia
Brazil
Pakistan
Chile
France
Portugal
Hong Kong
Switzerland
United States
India
Belgium
China
Italy
United Kingdom
Austria
Spain

location_facility: Universitatsklinikum Ulm, Oberer Eselsberg

location_facility: Regional Coordinating Centre India: The George Institute India

location_facility: Regional Coordinating Centre Europe: Unite de recherche clinique Lariboisiere

location_facility: Royal Brisbane and Women's Hospital Health Service District

location_facility: Regional Coordinating Centre China: The George Institute China

location_facility: Regional Coordinating Centre United Kingdom

location_facility: Regional Coordinating and Monitoring Centre: Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai Institute of Hypertension, Shanghai Second Medical University

location_facility: Hospital General Universitario de Albacete


acronym: LEAD

summary: The purpose of the study is to assess the efficacy of an extended injection interval schedule of lanreotide Autogel 120 mg in acromegalic subjects who are biochemically controlled on long term treatment with octreotide LAR 10 or 20 mg

location_facility: Hôpital Cochin - Saint-Vincent-de-Paul - La-Roche-Guyon

location_facility: University of Medicine and Pharmacy Iuliu Hatieganu

location_facility: Erasmus Medical Centre - Department of Endocrinology

location_facility: CHU de Tours - Hopital Bretonneau - Service Endocrinologie-Diabétologie Medecine B

location_facility: Hôpital Haut Lévêque - Unité de soins normalisés

location_facility: I.M. Sechenov Moscow Medical Academy - Endocrinology Department

location_facility: Federal State Institution "Endocrinology Research Centre - Federal agency of high-tech medical care" - Neuroendocrinology & Osteopathy Department

location_facility: Hospital das Clínicas de São Paulo - Internal Medicine - Neuroendocrine Unit - Division of Endocrinology and Metabolism

location_facility: Hôpital Archet 1 - Service d'Endocrinologie

location_facility: Clinic for Endocrinology, Diabetes and Metabolic Disorders, Clinical Center of Vojvodina, Hajduk Veljkova 3-9

location_facility: Sungkyunkwan University Samsung Medical Center

location_facility: Metaxa Hospital - Department of Endocrinology

location_facility: Skane University Hospital, Department of Endocrinology

location_facility: Hôpital Du Cluzeau - Service de Médecine B

location_facility: Karolinska University Hospital, Dpt of Endocrinology, Metabolism & Diabetology, Solna

location_facility: Righospitalet - University Department of Endocrinology & Internal Medicine P

location_facility: University Hospital in Krakow, Dept. of Endocrinology, Kopernika Str. 17

location_facility: Polykliniki Hospital - Department of Endocrinology

location_facility: Arhus University Hospital - Department of Medicinsk AVd M

location_facility: Hôpital du Bocage Sud - Service d'Endocrinologie

location_facility: Swietorkryskie Centrum Onkologii, UL. Artwinskiego 3 - Department of endocrinology and Nuclear Medecine

location_facility: Clinical Centre of Serbia - Institute for Endocrinology, Diabetes and Metabolic Diseases, - Dr Subotica Street n°13

location_facility: UMC Utrecht - Department of Endocrinology, Heidelberglaan 100

location_facility: Odense University Hospital - Department of Endocrinology

location_facility: Kuopio University Hospital - Department of Medicine, Internal Medicine/Endocrinology and Diabetology Division

location_facility: Yonsei University Severance Hospital - Department of Endocrinology and Metabolism

location_facility: Hopital Pitié-Salpêtrière - Service d'Endocrinologie

location_facility: Universidade Federal do Rio de Janeiro - Department of Internal Medicine - Section of Endocrinology - Neuroendocrine Research Center

location_facility: Hôpital Avicenne - Bâtiment Madeleine Breis

location_facility: Seoul National University hospital, 28 Yongon-dong Chongno-gu

location_facility: Department of Medicine, Haukeland Hospital Jonas Lies

location_facility: Hôpital Neurologique - Pierre Wertheimer

location_facility: Hôpital Lariboisière - Service Médecine Interne - Endocrinologie - Nutrition

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1, Ul. Pasteura 4

location_facility: Evangelismos Hospital - Department of Endocrinology

location_facility: Hôpital de Hautepierre, Service de Médecine Interne et Nutrition

location_facility: Helsinki University Central Hospital - (HUCH) Division of Endocrinology - Department of Medicine

location_facility: CH La Rochelle - Hopital Saint Louis - Service de Médecine interne - Endocrinologie - Maladies Métaboliques- Nutrition

location_facility: B IKA Panagia Hospital - Department of Endocrinology

location_facility: P. Stradins Clinical University Hospital - Department of Endocrinology

title: A Prospective, International, Multi-centric, Open-label Study to Assess the Efficacy of an Extended Injection Interval Schedule of Lanreotide Autogel 120 mg in Acromegalic Subjects Who Are Biochemically Controlled on the Long Term Treatment With Octreotide LAR 10 or 20 mg

location_country:
Finland
Poland
Norway
Denmark
Romania
Brazil
Netherlands
Sweden
Korea, Republic of
Latvia
Greece
Serbia
Russian Federation
France