title: A Double Blind, Randomized, Placebo-controlled, Parallel Group, Multicenter Phase 3 Pivotal Study to Assess the Safety and Efficacy of 1mg/kg/Day Intravenous DP-b99 Over 4 Consecutive Days Versus Placebo When Initiated Within Nine Hours of Acute Ischemic Stroke Onset

acronym: MACSI

summary: The purpose of this trial is to determine if intravenous administration of the metal ion trapping agent DP-b99 up to 9 hours following acute ischemic stroke onset, and then for 3 additional days (4 consecutive days in total) is effective in improving long term outcome. Patients will be followed up for 3 months after the stroke.

ReferenceCitation: Diener HC, Schneider D, Lampl Y, Bornstein NM, Kozak A, Rosenberg G. DP-b99, a membrane-activated metal ion chelator, as neuroprotective therapy in ischemic stroke. Stroke. 2008 Jun;39(6):1774-8. doi: 10.1161/STROKEAHA.107.506378. Epub 2008 Apr 10.

ReferenceCitation: Rosenberg G, Angel I, Kozak A. Clinical pharmacology of DP-b99 in healthy volunteers: first administration to humans. Br J Clin Pharmacol. 2005 Jul;60(1):7-16.

ReferenceCitation: Barkalifa R, Hershfinkel M, Friedman JE, Kozak A, Sekler I. The lipophilic zinc chelator DP-b99 prevents zinc induced neuronal death. Eur J Pharmacol. 2009 Sep 15;618(1-3):15-21. doi: 10.1016/j.ejphar.2009.07.019. Epub 2009 Jul 19.

ReferenceCitation: Rosenberg G, Bornstein N, Diener HC, Gorelick PB, Shuaib A, Lees K; MACSI investigators. The Membrane-Activated Chelator Stroke Intervention (MACSI) Trial of DP-b99 in acute ischemic stroke: a randomized, double-blind, placebo-controlled, multinational pivotal phase III study. Int J Stroke. 2011 Aug;6(4):362-7. doi: 10.1111/j.1747-4949.2011.00608.x. Epub 2011 Jun 6.

ReferenceCitation: Rosenberg G, Marshall LS, Caraco Y. The neuroprotective agent DP-b99 does not interact with s-warfarin in vivo despite significant CYP2C9 inhibition in vitro. Basic Clin Pharmacol Toxicol. 2011 Apr;108(4):289-92. doi: 10.1111/j.1742-7843.2010.00654.x. Epub 2010 Dec 16.

lead_sponsor: D-Pharm Ltd.

location_country:
Italy
Austria
Brazil
South Africa
Switzerland
Netherlands
Spain
Germany
France
Korea, Republic of
Poland
Israel
Slovakia
Hungary
Portugal
United States
Czech Republic
Canada

location_facility: Kenezy Korhaz Rendelointezet Egezsegugyi Szolgaltato Nonprofit Kft.

location_facility: Georg-August-Universitat Gottingen Neurologische Klinik

location_facility: Evangelische Kliniken Gelsenkirchen GmbH Klinik für Neurologie und Klinische Neurophysiologie

location_facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto Unidade de Emergência Centro de Estudos

location_facility: Johannes Gutenberg Universitat, Klinik und Poliklinik fur Neurologie

location_facility: Memorial Health University Medical Center

location_facility: Klinikum Köln Merheim, Department of Neurology

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Pomerania Traumatology Center, Regional Specialist Hospital im. Nicolaus Copernicus

location_facility: Universitätsklinikum Essen, Klinik und Poliklinik für Neurologie

location_facility: Neurology Clinic, Faculty Hospital in Martin

location_facility: Klinikum Chemnitz GmbH Chefarzt Klinik für Neurologie

location_facility: Santa Casa de Misericórdia de Porto Alegre Policlinica Santa Clara Sala de Neurologia

location_facility: Hospital Clinico Universitario De Valladolid

location_facility: Samodzielny Publiczny Zespol Zakladow Opieki Zdrowotnej w Sandomierzu

location_facility: County Hospital Pardubice Clinic of Neurology

location_facility: Consorcio Hospital General Universitario Valencia

location_facility: Medical University of Warsaw, Department of Neurology

location_facility: Clinic of Neurology, Stroke Center, Charles University

location_facility: Borsod-Abaúj-Zemplén County Hospital Miskolc

location_facility: Universitätsspital Zürich, Klinik für Neurologie

location_facility: Wojewodzki Szpital Specjalistyczny Nr 1 im. Prof. Jozefa Gasinskiego

location_facility: Universität Rostock Chefarzt Abteilung Neurologie

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

location_facility: Istituto Scientifico San Raffaele - Stroke Unit

location_facility: Klinikum der Otto-von-Guericke-Universität Magdeburg, Neurologische Universitätsklinik

location_facility: Marien-Krankenhaus gGmbH, Abteilung für Neurologie

location_facility: Centro de Estudos Egas Moniz - Hospital de Santa Maria

location_facility: Universitätsklinikum Ulm, Abteilung für Neurologie im RKU

location_facility: Hôpital Lariboisière - Service Neurologie

location_facility: Santa Casa de Misericordia de Belo Horizonte Departamento de Neurologia

location_facility: Dipartimento di Neuroscienze, Ospedale di Brotzu

location_facility: DRK Kliniken Berlin, Klinik fuer Neurologie

location_facility: Vivantes Klinikum Neukölln, Klinik für Neurologie, Stroke Unit

location_facility: University of Louisville, Kentucky Neuroscience Research

location_facility: Universitätsklinikum Leipzig AöR, Klinik und Poliklinik für Neurologie

location_facility: Instytut Psychiatrii i Neurologii Oddział Neurologiczny z Pododdziałem Udarowym

location_facility: Szpital Wolski im. dr Anny Gostyńskiej Samodzielny Publiczny Zakład Opieki Zdrowotnej, Oddział Neurologii

location_facility: Hospital Clinico Universitario de Santiago

location_facility: The University of Kentucky The Methodist Hospital

location_facility: Ärztlicher Direktor Neurologische Klinik, Neurologische Klink GmbH der Rhoen-Klinikum AG

location_facility: Wojskowy Instytut Medyczny, Oddział Neurologii

location_facility: Neurological Dept. Edith Wolfson Medical Center

location_facility: Szpital Powiatowy im. Marii Curie - Skłodowskiej w Skarżysku-Kamiennej

location_facility: Seoul National University Bundang Hospital

location_facility: University Hospital Hradec Kralove, Clinic of Neurology

location_facility: Fővárosi Önkormányzat Péterfy Sándor utcai Kórház- Rendelőintézet és Baleseti Központ

location_facility: Capital Health Regional Medical Center Neuroscience Institute

location_facility: Azienda Ospedaliera Universitaria "Santa Maria della Misericordia" Stroke Unit

location_facility: Medical University of Lublin, Department of Neurology, Stroke Unit

location_facility: Azienda Ospedaliera Sant'Andrea, Stroke Unit

location_facility: Universitätsklinikum Erlangen, Neurologische klinik

location_facility: Neurologische Universitätsklinik Freiburg, Neurozentrum

location_facility: Klinikum Bremerhaven-Reinkenheide gGmbH, Neurologische Klinik

location_facility: University Hospital Motol Clinic of Neurology

location_facility: Hospital Professor Doutor Fernando Fonseca, EPE

location_facility: Università di Roma "La Sapienza" - Stroke Unit

location_facility: Medisch Spectrum Twente Hoofd Afdeling Vasculaire Neurologie

location_facility: University of Debrecen, Medical and Health Science Center

location_facility: Hospitais da Universidadde de Coimbra, EPE

location_facility: Università di Perugia, Division of Internal and Cardiovascular Medicine - Stroke Unit


type: EudraCT Number

title: A Randomized, Open-Label Phase III Trial to Evaluate the Efficacy and Safety of Bexarotene (Targretin) Capsules Combined With PUVA, Compared to PUVA Treatment Alone in Patients With Mycosis Fungoides

summary:
RATIONALE: Ultraviolet light therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. It is not yet known whether ultraviolet light therapy is more effective with or without bexarotene in treating mycosis fungoides.

PURPOSE: Randomized phase III trial to compare the effectiveness of ultraviolet light therapy using methoxsalen with or without bexarotene in treating patients who have mycosis fungoides.

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Whittaker S, Ortiz P, Dummer R, Ranki A, Hasan B, Meulemans B, Gellrich S, Knobler R, Stadler R, Karrasch M. Efficacy and safety of bexarotene combined with psoralen-ultraviolet A (PUVA) compared with PUVA treatment alone in stage IB-IIA mycosis fungoides: final results from the EORTC Cutaneous Lymphoma Task Force phase III randomized clinical trial (NCT00056056). Br J Dermatol. 2012 Sep;167(3):678-87. doi: 10.1111/j.1365-2133.2012.11156.x.

family: Whittaker

full_name: S. Whittaker

given: S.

sequence: first

family: Ortiz

full_name: P. Ortiz

given: P.

sequence: additional

family: Dummer

full_name: R. Dummer

given: R.

family: Ranki

full_name: A. Ranki

given: A.

family: Hasan

full_name: B. Hasan

given: B.

family: Meulemans

full_name: B. Meulemans

family: Gellrich

full_name: S. Gellrich

family: Knobler

full_name: R. Knobler

family: Stadler

full_name: R. Stadler

family: Karrasch

full_name: M. Karrasch

given: M.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: British Journal of Dermatology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Efficacy and safety of bexarotene combined with psoralen-ultraviolet A (PUVA) compared with PUVA treatment alone in stage IB-IIA mycosis fungoides: final results from the EORTC Cutaneous Lymphoma Task Force phase III randomized clinical trial 21011 (NCT00

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Italy
Austria
Switzerland
Netherlands
Finland
France
Israel
Hungary
Belgium
Spain
Denmark
Germany
United Kingdom

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg

location_facility: Southwest German Cancer Center at Eberhard-Karls-University

location_facility: Allgemeines Krankenhaus - Universitatskliniken

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Hospital Universitario Nuestra Senora de la Candelaria

location_facility: Royal Infirmary of Edinburgh at Little France

intervention_type: Procedure

lead_sponsor_type: industriel

status_simplified: Unknown


ReferenceType: result

ReferenceCitation: Campbell P, Thomas CM. Belinostat for the treatment of relapsed or refractory peripheral T-cell lymphoma. J Oncol Pharm Pract. 2017 Mar;23(2):143-147. doi: 10.1177/1078155216634178. Epub 2016 Jun 23. Review.

name: Department of Pharmacy, NewYork-Presbyterian Hospital, University Hospital of Columbia and Cornell, New York, USA

family: Campbell

full_name: Peter Campbell

given: Peter

name: Department of Clinical Health Professions, College of Pharmacy, St. John’s University, New York, USA

family: Thomas

full_name: Christan M Thomas

given: Christan M

journal_name: Journal of Oncology Pharmacy Practice

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

intervention_type: Drug

status: Completed

study_start_date_type: Actual

lead_sponsor: Spectrum Pharmaceuticals, Inc

location_country:
Italy
United States
South Africa
Netherlands
Germany
Croatia
France
Poland
Israel
Slovakia
Hungary
Belgium
Russian Federation
Spain
Denmark
Canada
United Kingdom

acronym: PTCL

location_facility: Wojewódzki Szpital Specjalistyczny im M. Kopernika w Łodzi Oddział Hematologii - Klinika Hematologii

location_facility: Illinois Cancer Specialists/Cancer Care & Hematology Specialists of Chicagoland

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Wojskowy Instytut Medyczny Klinika Chorób/Wewnętrznych i Hematologii Centralnego Szpitala

location_facility: Russian Cancer Research Centre named after N.N. Blokhin of Russian Academy of Medical Sciences

location_facility: Cliniques Universitaires UCL Mont Godinne, Service Hématologie

location_facility: H:S Rigshospitalet, The Finsen Centre, KAT, Haematology Department 4241

location_facility: Klinika Hematologie a Onkohematologie FNLP a LF UPJS

location_facility: Hadassah University Hospital Sharet Building Department of Hematology

location_facility: Belgyógyászati Klinika es Kardiologial Központ

location_facility: State Therapeutical and Prophylactic Institution Chelyabinsk Regional Clinical Oncology Dispensary

location_facility: University of Tennessee Cancer Institute

location_facility: University of Liege, Divisions of Hematology and Medical Oncology

location_facility: The UT Health Science Centre at San Antonio

location_facility: Erie County Medical Center (Roswell Park)

location_facility: Medical Oncology 2nd Floor Radiotherapy building Steve Biko Academic Hospital

location_facility: Instytut Hematologii i Transfuzjologii Klinika Hematologii

location_facility: St James's Institute of Oncology Bexley Wing

location_facility: Groupe Hospitalier Sud Réunion, Site Saint-Pierre

location_facility: Hôpital de l'Archet, Centre Hospitalier Universitaire (CHU) de Nice, Hématologie Clinique

location_facility: University Medical Center Groningen UMCG, Department of Haematologie

location_facility: Accelerated Community Oncology Reseaerch Network, Inc. (ACORN)

location_facility: VU Medical Center, Department of Haematology

location_facility: Universitätsklinikum (AöR) der Martin-Luther-Universität Halle-Wittenberg

location_facility: Clinique Universitaire Saint Luc, Service Hématologie

location_facility: The Royal Marsden Haemato-Oncology Wards

location_facility: Ospedale Sant'Orsola, Instituto di Ematologia e Oncologia Medica

location_facility: Klinik Essen Süd, Evangelisches Krankenhaus

location_facility: Uniwersyteckie Centrum Kliniczne Klinika Hematologii i Transplantologii

location_facility: Hospital Universitario Central de Asturias

location_facility: Klinika Nowotworów Ukladu Chlonnego Centrum Onkologii Instytut Marii Sklodowskiej-Curie

location_facility: Isala Clinics, Department of Haematololgy

location_facility: Yale Cancer Center-Section of Medical Oncology

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Leitender Oberarzt/Klinik für Onkologie und Hämatologie

location_facility: Washington University School of Medicine

location_facility: Institute of Cancer/ Centre for Medical Oncology/Barts and The London School of Medicine and Dentistry

location_facility: Universitätsmedizin der johannes Gutenberg -Universität Mainz

location_facility: Pretoria Academic Hospital, Department of Radiation Oncology

location_facility: Fred Hutchinson Cancer Research Center - Seattle Cancer Care Alliance

location_facility: Hospital General Universitario Gregorio Maranón

location_facility: Northern Centre for Cancer Care, Freeman Hospital

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

location_facility: Universität Göttingen, Abteilung Hämatologie und Onkologie

location_facility: Szpital Wojewódzki w Opolu/Oddział Hematologii

location_facility: Tygerberg Hospital, Department of Radiation Oncology

location_facility: Münchner Studienzentrum Klinikum Rechts der Isar

location_facility: Rambam Medical Center Department of Hematology

ipd_sharing: No

source: euctr

title: A Multicenter, Open-Label Trial of Belinostat in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma

summary: The purpose of this study is to assess efficacy and safety of belinostat in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL), who failed at least one prior systemic therapy.

status_simplified: Completed


title: Expanded Access Program Using Uromune for Patients With Recurrent Urinary Tract Infections (rUTI)

summary: An Expanded Access Program for UROMUNE® for patients suffering from recurrent/chronic urinary tract infections of diverse etiology. This is for individuals for whom antibiotic therapy has failed, but of consideration in all cases, taking into account antibiotic-induced adverse reactions and increasing antibiotic resistance.

status: Available

study_type: Expanded Access

ReferenceType: background

ReferenceCitation: Benito-Villalvilla C, Cirauqui C, Diez-Rivero CM, Casanovas M, Subiza JL, Palomares O. MV140, a sublingual polyvalent bacterial preparation to treat recurrent urinary tract infections, licenses human dendritic cells for generating Th1, Th17, and IL-10 responses via Syk and MyD88. Mucosal Immunol. 2017 Jul;10(4):924-935. doi: 10.1038/mi.2016.112. Epub 2016 Dec 14.

ReferenceCitation: Yang B, Foley S. First experience in the UK of treating women with recurrent urinary tract infections with the bacterial vaccine Uromune(®). BJU Int. 2018 Feb;121(2):289-292. doi: 10.1111/bju.14067. Epub 2017 Nov 23.

family: Yang

full_name: Bob Yang

given: Bob

family: Foley

full_name: Stephen Foley

given: Stephen

journal_name: BJU International

title: First experience in the UK of treating women with recurrent urinary tract infections with the bacterial vaccine Uromune®

ReferenceCitation: Lorenzo-Gómez MF, Padilla-Fernández B, García-Cenador MB, Virseda-Rodríguez ÁJ, Martín-García I, Sánchez-Escudero A, Vicente-Arroyo MJ, Mirón-Canelo JA. Comparison of sublingual therapeutic vaccine with antibiotics for the prophylaxis of recurrent urinary tract infections. Front Cell Infect Microbiol. 2015 Jun 3;5:50. doi: 10.3389/fcimb.2015.00050. eCollection 2015.

full_name: MarÃa F. Lorenzo-GÃ³mez

given: MarÃa F.

family: Padilla-FernÃ¡ndez

full_name: BÃ¡rbara Padilla-FernÃ¡ndez

given: BÃ¡rbara

family: GarcÃa-Cenador

full_name: MarÃa B. GarcÃa-Cenador

given: MarÃa B.

family: Virseda-RodrÃguez

full_name: Ãlvaro J. Virseda-RodrÃguez

given: Ãlvaro J.

family: MartÃn-GarcÃa

full_name: Isidoro MartÃn-GarcÃa

given: Isidoro

family: SÃ¡nchez-Escudero

full_name: Alfonso SÃ¡nchez-Escudero

given: Alfonso

family: Vicente-Arroyo

full_name: Manuel J. Vicente-Arroyo

given: Manuel J.

full_name: JosÃ© A. MirÃ³n-Canelo

given: JosÃ© A.

currency_apc_doaj: USD

journal_name: Frontiers in Cellular and Infection Microbiology

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 OAI-PMH doi match)

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

ReferenceCitation: Ramírez Sevilla C, Gómez Lanza E, Manzanera JL, Martín JAR, Sanz MÁB. Active immunoprophyilaxis with uromune® decreases the recurrence of urinary tract infections at three and six months after treatment without relevant secondary effects. BMC Infect Dis. 2019 Oct 28;19(1):901. doi: 10.1186/s12879-019-4541-y.

family: Ramírez Sevilla

full_name: Cristóbal Ramírez Sevilla

given: Cristóbal

family: Gómez Lanza

full_name: Esther Gómez Lanza

given: Esther

family: Manzanera

full_name: Juan Llopis Manzanera

given: Juan Llopis

family: Martín

full_name: Jose Antonio Romero Martín

given: Jose Antonio Romero

family: Sanz

full_name: Miguel Ángel Barranco Sanz

given: Miguel Ángel Barranco

location_country: Luxembourg Sweden Serbia Netherlands Finland France Czechia Slovakia Norway Romania Belgium Turkey Denmark Germany Slovenia

location_facility:
Luxembourg
Sweden
Serbia
The Netherlands
Finland
France
Slovakia
Slovenia
Norway
Romania
Belgium
Turkey
Denmark
Germany
Czech Republic


title: A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of 40 mg Glatiramer Acetate Injection in Subjects With Amyotrophic Lateral Sclerosis (ALS)

summary: Teva is developing 40 mg/ml Glatiramer Acetate (GA) Injection , administered once daily under the skin, for the treatment of ALS. The study drug is a higher dose formulation of Copaxone® (20 mg/ml GA), a marketed medication, approved for the treatment of relapsing-remitting multiple sclerosis. GA is an immunomodulating drug that has anti inflammatory and neuroprotective properties, which are believed to be of therapeutic value in ALS. The study treatment duration is 1 year (52 weeks).

lead_sponsor: Teva Pharmaceutical Industries, Ltd.

location_country:
Italy
France
Israel
Belgium
Germany
United Kingdom

location_facility:
Teva UK
Teva Germany
Teva Benelux
Teva Italy
Teva Israel
Teva France


title: Prospective LongitudinAl Trial of FFRct: Outcome and Resource IMpacts

acronym: PLATFORM

summary: The objective of the PLATFORM Study is to compare clinical outcomes, resource utilization, and quality of life (QOL) of FFRCT-guided evaluation versus standard practice evaluation in patients with suspected CAD in order to further inform patients, health care providers, and other stakeholders about which technologies are most effective and efficient in the diagnosis of CAD

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Douglas PS, De Bruyne B, Pontone G, Patel MR, Norgaard BL, Byrne RA, Curzen N, Purcell I, Gutberlet M, Rioufol G, Hink U, Schuchlenz HW, Feuchtner G, Gilard M, Andreini D, Jensen JM, Hadamitzky M, Chiswell K, Cyr D, Wilk A, Wang F, Rogers C, Hlatky MA; PLATFORM Investigators. 1-Year Outcomes of FFRCT-Guided Care in Patients With Suspected Coronary Disease: The PLATFORM Study. J Am Coll Cardiol. 2016 Aug 2;68(5):435-445. doi: 10.1016/j.jacc.2016.05.057.

family: Douglas

full_name: Pamela S. Douglas

given: Pamela S.

family: De Bruyne

full_name: Bernard De Bruyne

given: Bernard

family: Pontone

full_name: Gianluca Pontone

given: Gianluca

family: Patel

full_name: Manesh R. Patel

given: Manesh R.

family: Norgaard

full_name: Bjarne L. Norgaard

given: Bjarne L.

family: Byrne

full_name: Robert A. Byrne

given: Robert A.

family: Curzen

full_name: Nick Curzen

given: Nick

family: Purcell

full_name: Ian Purcell

given: Ian

family: Gutberlet

full_name: Matthias Gutberlet

given: Matthias

family: Rioufol

full_name: Gilles Rioufol

given: Gilles

family: Hink

full_name: Ulrich Hink

given: Ulrich

family: Schuchlenz

full_name: Herwig Walter Schuchlenz

given: Herwig Walter

family: Feuchtner

full_name: Gudrun Feuchtner

given: Gudrun

family: Gilard

full_name: Martine Gilard

given: Martine

family: Andreini

full_name: Daniele Andreini

given: Daniele

family: Jensen

full_name: Jesper M. Jensen

given: Jesper M.

family: Hadamitzky

full_name: Martin Hadamitzky

given: Martin

family: Chiswell

full_name: Karen Chiswell

given: Karen

family: Cyr

full_name: Derek Cyr

given: Derek

family: Wilk

full_name: Alan Wilk

given: Alan

family: Wang

full_name: Furong Wang

given: Furong

family: Rogers

full_name: Campbell Rogers

given: Campbell

family: Hlatky

full_name: Mark A. Hlatky

given: Mark A.

journal_name: Journal of the American College of Cardiology

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repository_institution: University of Southampton - ePrints Soton

title: 1-Year Outcomes of FFR CT -Guided Care in Patients With Suspected Coronary Disease

ReferenceCitation: Hlatky MA, De Bruyne B, Pontone G, Patel MR, Norgaard BL, Byrne RA, Curzen N, Purcell I, Gutberlet M, Rioufol G, Hink U, Schuchlenz HW, Feuchtner G, Gilard M, Andreini D, Jensen JM, Hadamitzky M, Wilk A, Wang F, Rogers C, Douglas PS; PLATFORM Investigators. Quality-of-Life and Economic Outcomes of Assessing Fractional Flow Reserve With Computed Tomography Angiography: PLATFORM. J Am Coll Cardiol. 2015 Dec 1;66(21):2315-2323. doi: 10.1016/j.jacc.2015.09.051. Epub 2015 Oct 14.

location_country:
Italy
Austria
Germany
France
Belgium
Denmark
United States
United Kingdom

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Freeman Hospital - Therapeutics & Cardiac Research Team

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Duke University Clinical Research Institution

location_facility: Cardiovascular Hospital -Interventional Cardiology Dept, Hospices Civils de Lyon and Claude Bernard University France

location_facility: Innsbruck Medical University, Department of Radiology II

location_facility: Deutsches Herzzentrum München - ISAResearch Centre

location_facility: LKH-GRAZ-West - Department of Cardiology


ReferenceCitation: Buyse GM, Voit T, Schara U, Straathof CSM, D'Angelo MG, Bernert G, Cuisset JM, Finkel RS, Goemans N, McDonald CM, Rummey C, Meier T; DELOS Study Group. Efficacy of idebenone on respiratory function in patients with Duchenne muscular dystrophy not using glucocorticoids (DELOS): a double-blind randomised placebo-controlled phase 3 trial. Lancet. 2015 May 2;385(9979):1748-1757. doi: 10.1016/S0140-6736(15)60025-3. Epub 2015 Apr 20.

family: Buyse

full_name: Gunnar M Buyse

given: Gunnar M

family: Voit

full_name: Thomas Voit

given: Thomas

family: Schara

full_name: Ulrike Schara

given: Ulrike

family: Straathof

full_name: Chiara S M Straathof

given: Chiara S M

family: D'Angelo

full_name: M Grazia D'Angelo

given: M Grazia

family: Bernert

full_name: Günther Bernert

given: Günther

family: Cuisset

full_name: Jean-Marie Cuisset

given: Jean-Marie

family: Finkel

full_name: Richard S Finkel

given: Richard S

family: Goemans

full_name: Nathalie Goemans

given: Nathalie

family: McDonald

full_name: Craig M McDonald

given: Craig M

family: Rummey

full_name: Christian Rummey

given: Christian

family: Meier

full_name: Thomas Meier

journal_name: The Lancet

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Meier T, Rummey C, Leinonen M, Spagnolo P, Mayer OH, Buyse GM; DELOS Study Group. Characterization of pulmonary function in 10-18 year old patients with Duchenne muscular dystrophy. Neuromuscul Disord. 2017 Apr;27(4):307-314. doi: 10.1016/j.nmd.2016.12.014. Epub 2017 Jan 6.

family: Leinonen

full_name: Mika Leinonen

given: Mika

family: Spagnolo

full_name: Paolo Spagnolo

given: Paolo

family: Mayer

full_name: Oscar H. Mayer

given: Oscar H.

full_name: Gunnar M. Buyse

given: Gunnar M.

full_name: G. Bernert

given: G.

family: Knipp

full_name: F. Knipp

given: F.

full_name: G.M. Buyse

full_name: N. Goemans

given: N.

family: Van den Hauwe

full_name: M. Van den Hauwe

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

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

repository_institution: University College London - UCL Discovery

title: Characterization of pulmonary function in 10–18 year old patients with Duchenne muscular dystrophy

location_country:
Italy
Austria
Sweden
Switzerland
Netherlands
Germany
France
Belgium
Spain
United States

location_facility: Azienda Ospedaliera Niguarda Ca' Granda Centro Clinico Nemo

location_facility: University of California Davis Medical Center

location_facility: Carolinas Medical Center, Neurosciences and Spine Institute

location_facility: Monroe Carell, Jr. Children's Hospital at Vanderbilt

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: Universitätsklinik Freiburg Zentrum für Kinderheilkunde und Jugendmedizin

location_facility: University Hospitals Leuven- Children Hospital

location_facility: University of Texas Southwestern Medical Center

location_facility: Azienda Ospedaliera Universitaria della Seconda Università degli Studi di Napoli

location_facility: Universitätsklinikum Essen, Zentrum für Kinderheikunde

title: A Phase III Double-Blind, Randomised, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Idebenone in 10-18 Year Old Patients With Duchenne Muscular Dystrophy

summary: The aim of this Phase III study was to assess the efficacy of idebenone on pulmonary function, motor function, muscle strength and quality of life in patients with DMD. Furthermore, the safety and tolerability of idebenone was assessed.


title: A Randomized, Double-Blind, Placebo-Controlled, Stratified, Parallel-Group, Multicenter, Dose-Ranging Study Evaluating Four Oral Doses of TCH346 (1.0, 2.5, 7.5 and 15 mg) Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis

summary: This is a global multicenter study designed to evaluate the safety and clinical effects of 4 oral doses of TCH346 (1.0, 2.5, 7.5, and 15 mg) compared to placebo in patients with mild or mild to moderate stages of ALS. The study consists of 3 phases: screening (up to 2 weeks), run-in (16 weeks), and a double-blind treatment phase of variable duration (at least 24 weeks).

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United States
Switzerland
Netherlands
Germany
France
Belgium
Canada
United Kingdom

location_facility:
Novartis Netherlands
Novartis UK
Novartis France
Novartis Italy
Novartis Belgium
Novartis Switzerland
Novartis USA
Novartis CANADA
Novartis Germany


type: Other Identifier

title: Evaluation of the Impact of Emotional Skills of Young Women (≤ 45 Years), With Non-metastatic Breast Cancer, and Their Partner on Adjustment to Cancer

summary: The KALICOU 3 study will evaluate the effect of emotional skills of patients and their partners on their individual disease subjective experience during care pathways, from chemotherapy to surveillance.

status: Unknown status

study_completion_date_type: Anticipated

primary_purpose: Other

enrollment_type: Anticipated

lead_sponsor: Centre Oscar Lambret

location_facility: Unité d'Oncologie et d'hématologie ONCOSUD

location_facility: Centre Pierre Curie - SCP de radiologie et d'imagerie médicale

location_facility: Le Confluent - Centre Catherine de Sienne

intervention_type: Other


type: Registry Identifier

title: Réseau Structurant Sur le Cancer de la Prostate du Grand Ouest

acronym: RESCAP

summary:
The project aims at developing and structuring a network of clinicians, pathologists, and scientists, from the "Grand Ouest" area, most of them already involved in prostate cancer management and research.

Patients treated by radical prostatectomy will be recruited within the ReSCaP network of clinicians, with centralized database and standardized bio-resource collection, including prostate and adipose tissue samples. Seven clinical centers will participate to the network, 6 recruiting mainly Caucasian patients, and 1 from the French West Indies recruiting mainly African Caribbean patients. After 18 months, 1000 patients will be included.

The main goal is to study the relationships between adipose tissue/lipids and prostate cancer aggressiveness. In fact, adipose tissue is likely to be involved in cancer progression at many levels: abdominal obesity has been associated with aggressive disease, and poly-unsaturated fatty acids (PUFAs), as well as cytokines produced by adipocytes (adipokines) have an impact on cancer cells growth and migration in vitro. Moreover, adipose tissue is the preferential site of storage of persistent organic pollutants with estrogenic properties, which could impact cancer progression.

The study will analyze the association between adipose tissue (distant from the prostate) composition and cancer aggressiveness. Among the 1000 patients, 100 aggressive tumors will be selected according to the d'Amico criteria (Gleason score 8 or more and/or pT3 tumors). They will be matched with 100 potentially indolent prostate cancers (Gleason 6 or less, and PSA less than 10, and pT2 stage on the surgical specimen). These 200 adipose tissue samples will be analyzed for 1/ the lipid profile, including the fatty acid composition, particularly PUFAs, that reflects past dietary fat intake, 2/ adipokine expression, and 3/ tissue concentrations of persistent organic pollutants belonging to the class of organochlorine pesticides with hormone-like activity.

lead_sponsor: University Hospital, Tours

location_country: France Guadeloupe

location_facility:
University Hospital
Uniersity Hospital
Urology CHRU-TOURS

lead_sponsor_type: academique


title: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. A 52 Weeks Double Blind Study With 500mcg Roflumilast Once Daily Versus Placebo. Ratio-Study.

summary: The purpose of this study is to investigate the effect of 500mcg roflumilast vs placebo on exacerbation rate and pulmonary function as well as quality of life in patients with chronic obstructive pulmonary disease (COPD).

ReferenceCitation: Facius A, Krause A, Claret L, Bruno R, Lahu G. Modeling and Simulation of Pivotal Clinical Trials Using Linked Models for Multiple Endpoints in Chronic Obstructive Pulmonary Disease With Roflumilast. J Clin Pharmacol. 2017 Aug;57(8):1042-1052. doi: 10.1002/jcph.885. Epub 2017 Apr 17.

name: Takeda Pharmaceuticals International GmbH; Glattpark-Opfikon (Zürich) Switzerland

family: Facius

full_name: Axel Facius

given: Axel

name: Pharsight Consulting Services; Pharsight, a Certara Company; Mountain View CA USA

family: Krause

full_name: Andreas Krause

given: Andreas

family: Claret

full_name: Laurent Claret

given: Laurent

family: Bruno

full_name: Rene Bruno

given: Rene

family: Lahu

full_name: Gezim Lahu

given: Gezim

journal_name: The Journal of Clinical Pharmacology

ReferenceCitation: Rennard SI, Calverley PM, Goehring UM, Bredenbröker D, Martinez FJ. Reduction of exacerbations by the PDE4 inhibitor roflumilast--the importance of defining different subsets of patients with COPD. Respir Res. 2011 Jan 27;12:18. doi: 10.1186/1465-9921-12-18.

family: Rennard

full_name: Stephen I Rennard

given: Stephen I

family: Calverley

full_name: Peter MA Calverley

given: Peter MA

family: Goehring

full_name: Udo M Goehring

given: Udo M

family: Bredenbröker

full_name: Dirk Bredenbröker

given: Dirk

family: Martinez

full_name: Fernando J Martinez

given: Fernando J

currency_apc_doaj: GBP

journal_name: Respiratory Research

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

title: Reduction of exacerbations by the PDE4 inhibitor roflumilast - the importance of defining different subsets of patients with COPD

lead_sponsor: AstraZeneca

location_country:
Italy
Austria
South Africa
Switzerland
Netherlands
Spain
France
Poland
Hungary
Australia
Russian Federation
Portugal
Canada
United Kingdom


title: Tear Analysis by Isoelectric Focusing in Clinically Isolated Syndrome as Multiple Sclerosis Criterion Among Patients With or Without Lesions at the Magnetic Resonance Imaging (Oligoclonal Profile of Tears)

acronym: POLAR

summary: This is a multicentric and prospective study for the validation of a diagnostic method in multiple sclerosis. Our hypothesis is that there is a characteristic profile of tears that can be recognized in order to help in the diagnosis of this pathology and that could possibly replace the lumbar punction which is an invasive method. Semi-automatic and automatic techniques of isoelectric focusing will be developed for analyzing data from tears. These results will help in the identification of markers of this disease.

primary_purpose: Diagnostic

lead_sponsor: Lille Catholic University

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre Hospitalier Régional Universitaire de Strasbourg

location_facility: Groupe Hospitalier de l'Institut Catholique de Lille

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Centre Hospitalier Intercommunal Poissy-St-Germain

location_facility: Centre Hospitalier Univetrsitaire de Rouen

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Centre Hospitalier Universitaire de Lyon

location_facility: Centre Hospitalier Régional Universitaire de Lille


title: Tear Analysis in the Diagnosis of Primary Progressive Forms of Multiple Sclerosis

acronym: LARMES

summary: In the primary progressive multiple sclerosis, the detection of oligoclonal bands in cerebrospinal fluid is critical for the diagnosis. However, lumbar puncture for cerebrospinal fluid collection is considered relatively invasive. Our hypothesis is that oligoclonal bands detection in tears is possible and useful for the diagnosis of multiple sclerosis.

location_facility: Centre hospitalier régional universtaire

location_facility: Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)

location_facility: Centre hospitalier universitaire (CHU), Nice

location_facility: Assistance Publique - Hôpitaux de Marseille

location_facility: Centre hospitalier régional universitaire


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (50 mg, 100 mg) of Desvenlafaxine Sustained-Release Tablets in Adult Outpatients With Major Depressive Disorder

summary: The primary objective is to compare the antidepressant efficacy, safety, and tolerability of DVS SR versus placebo in subjects with Major Depressive Disorder. Additional objectives include testing both general and functional quality-of-life outcomes and satisfaction with therapy reported by the subject.

ReferenceCitation: Zilcha-Mano S, Wang X, Wajsbrot DB, Boucher M, Fine SA, Rutherford BR. Trajectories of Function and Symptom Change in Desvenlafaxine Clinical Trials: Toward Personalized Treatment for Depression. J Clin Psychopharmacol. 2021 Sep-Oct 01;41(5):579-584. doi: 10.1097/JCP.0000000000001435.

family: Zilcha-Mano

full_name: Sigal Zilcha-Mano

given: Sigal

family: Wang

full_name: Xuemei Wang

given: Xuemei

family: Wajsbrot

full_name: Dalia B. Wajsbrot

given: Dalia B.

family: Boucher

full_name: Matthieu Boucher

given: Matthieu

family: Fine

full_name: Stuart A. Fine

given: Stuart A.

family: Rutherford

full_name: Bret R. Rutherford

given: Bret R.

journal_name: Journal of Clinical Psychopharmacology

oa_colors: green other

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Soares CN, Zhang M, Boucher M. Categorical improvement in functional impairment in depressed patients treated with desvenlafaxine. CNS Spectr. 2019 Jun;24(3):322-332. doi: 10.1017/S1092852917000633. Epub 2017 Nov 15.

family: Soares

full_name: Claudio N. Soares

given: Claudio N.

family: Zhang

full_name: Min Zhang

given: Min

bso_classification: Social sciences

journal_name: CNS Spectrums

oa_colors: green hybrid

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

publisher: Cambridge University Press (CUP)

publisher_dissemination: Cambridge University Press

publisher_group: Cambridge University Press

publisher_normalized: Cambridge University Press

ReferenceCitation: McIntyre RS, Fayyad R, Mackell JA, Boucher M. Effect of metabolic syndrome and thyroid hormone on efficacy of desvenlafaxine 50 and 100 mg/d in major depressive disorder. Curr Med Res Opin. 2016;32(3):587-99. doi: 10.1185/03007995.2015.1136603. Epub 2016 Jan 13.

name: University of Toronto, Toronto, ON, Canada;

family: McIntyre

full_name: Roger S. McIntyre

given: Roger S.

family: Fayyad

full_name: Rana Fayyad

given: Rana

ReferenceCitation: McIntyre RS, Fayyad RS, Guico-Pabia CJ, Boucher M. A Post Hoc Analysis of the Effect of Weight on Efficacy in Depressed Patients Treated With Desvenlafaxine 50 mg/d and 100 mg/d. Prim Care Companion CNS Disord. 2015 Jun 4;17(3). doi: 10.4088/PCC.14m01741. eCollection 2015.

journal_name: The Primary Care Companion For CNS Disorders

ReferenceCitation: Thase ME, Fayyad R, Cheng RF, Guico-Pabia CJ, Sporn J, Boucher M, Tourian KA. Effects of desvenlafaxine on blood pressure in patients treated for major depressive disorder: a pooled analysis. Curr Med Res Opin. 2015 Apr;31(4):809-20. doi: 10.1185/03007995.2015.1020365. Epub 2015 Mar 26.

ReferenceCitation: Soares CN, Endicott J, Boucher M, Fayyad RS, Guico-Pabia CJ. Predictors of functional response and remission with desvenlafaxine 50 mg/d in patients with major depressive disorder. CNS Spectr. 2014 Dec;19(6):519-27. doi: 10.1017/S1092852914000066. Epub 2014 Feb 26.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country:
South Africa
Finland
Croatia
France
Lithuania
Poland
Slovakia
Romania
Estonia
Latvia


design_allocation: Non-Randomized

status: Recruiting

lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Austria
Sweden
Germany
France
Poland
Ireland
Russian Federation
New Zealand
Denmark
United States
United Kingdom
Canada
Taiwan
Ukraine

acronym: Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in mCRPC (KEYNOTE-365)

location_facility: Call for Information (Investigational Site 0016)

location_facility: Call for Information (Investigational Site 2075)

location_facility: Call for Information (Investigational Site 2038)

location_facility: Call for Information (Investigational Site 0007)

location_facility: Call for Information (Investigational Site 2018)

location_facility: Call for Information (Investigational Site 2065)

location_facility: Call for Information (Investigational Site 2002)

location_facility: Call for Information (Investigational Site 0010)

location_facility: Call for Information (Investigational Site 0005)

location_facility: Call for Information (Investigational Site 0015)

ipd_sharing: Yes

title: Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365)

summary: The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combination therapy in patients with metastatic castrate resistant prostate cancer (mCRPC). There will be nine cohorts in this study: Cohort A will receive pembrolizumab + olaparib, Cohort B will receive pembrolizumab + docetaxel + prednisone, Cohort C will receive pembrolizumab + enzalutamide, Cohort D will receive pembrolizumab + abiraterone + prednisone Cohort E will receive pembrolizumab+lenvatinib, Cohort F will receive pembrolizumab+lenvatinib, Cohort G will receive pembrolizumab/vibostolimab coformulation (MK-7684A), Cohort H will receive pembrolizumab/vibostolimab coformulation, and Cohort I will receive pembrolizumab+carboplatin+etoposide in Arm 1 and carboplatin+etoposide in Arm 2. Outcome measures will be assessed individually for each cohort.

status_simplified: Ongoing


title: A Randomized, Open Label Multi-Center Study of XRP6258 at 25 mg/m^2 in Combination With Prednisone Every 3 Weeks Compared to Mitoxantrone in Combination With Prednisone For The Treatment of Hormone Refractory Metastatic Prostate Cancer Previously Treated With A Taxotere®-Containing Regimen

acronym: TROPIC

summary: This is a randomized, open-label, multi-center study comparing the safety and efficacy of XRP6258 plus prednisone to mitoxantrone plus prednisone in the treatment of hormone refractory metastatic prostate cancer previously treated with a Taxotere®-containing regimen. The primary objective is overall survival. Secondary objectives include progression free survival, overall response rate, prostate-specific antigen (PSA) response/progression, pain response/progression, overall safety, and pharmacokinetics. Patients will be treated until disease progression, death, unacceptable toxicity, or for a maximum of 10 cycles. Patients will have long-term follow-up for a maximum of up to 2 years.

ReferenceCitation: Lorente D, Mateo J, Templeton AJ, Zafeiriou Z, Bianchini D, Ferraldeschi R, Bahl A, Shen L, Su Z, Sartor O, de Bono JS. Baseline neutrophil-lymphocyte ratio (NLR) is associated with survival and response to treatment with second-line chemotherapy for advanced prostate cancer independent of baseline steroid use. Ann Oncol. 2015 Apr;26(4):750-755. doi: 10.1093/annonc/mdu587. Epub 2014 Dec 23.

family: Lorente

full_name: D. Lorente

given: D.

family: Mateo

full_name: J. Mateo

given: J.

family: Templeton

full_name: A.J. Templeton

family: Zafeiriou

full_name: Z. Zafeiriou

given: Z.

family: Bianchini

full_name: D. Bianchini

family: Ferraldeschi

full_name: R. Ferraldeschi

given: R.

family: Bahl

full_name: A. Bahl

given: A.

family: Shen

full_name: L. Shen

given: L.

family: Su

full_name: Z. Su

family: Sartor

full_name: O. Sartor

given: O.

family: de Bono

full_name: J.S. de Bono

journal_name: Annals of Oncology

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

title: Baseline neutrophil–lymphocyte ratio (NLR) is associated with survival and response to treatment with second-line chemotherapy for advanced prostate cancer independent of baseline steroid use

ReferenceCitation: Bahl A, Oudard S, Tombal B, Ozgüroglu M, Hansen S, Kocak I, Gravis G, Devin J, Shen L, de Bono JS, Sartor AO; TROPIC Investigators. Impact of cabazitaxel on 2-year survival and palliation of tumour-related pain in men with metastatic castration-resistant prostate cancer treated in the TROPIC trial. Ann Oncol. 2013 Sep;24(9):2402-8. doi: 10.1093/annonc/mdt194. Epub 2013 May 30.

family: Oudard

full_name: S. Oudard

given: S.

family: Tombal

full_name: B. Tombal

given: B.

family: Özgüroĝlu

full_name: M. Özgüroĝlu

given: M.

family: Hansen

full_name: S. Hansen

family: Kocak

full_name: I. Kocak

given: I.

family: Gravis

full_name: G. Gravis

given: G.

family: Devin

full_name: J. Devin

ReferenceCitation: Pouessel D, Oudard S, Gravis G, Priou F, Shen L, Culine S. [Cabazitaxel for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: the TROPIC study in France]. Bull Cancer. 2012 Jul-Aug;99(7-8):731-41. doi: 10.1684/bdc.2012.1608. French.

title: Cabazitaxel dans le cancer de la prostate métastatique résistant à la castration ayant progressé pendant ou après traitement par docétaxel : l'expérience française de l'essai TROPIC

ReferenceCitation: de Bono JS, Oudard S, Ozguroglu M, Hansen S, Machiels JP, Kocak I, Gravis G, Bodrogi I, Mackenzie MJ, Shen L, Roessner M, Gupta S, Sartor AO; TROPIC Investigators. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010 Oct 2;376(9747):1147-54. doi: 10.1016/S0140-6736(10)61389-X.

location_country:
Finland
Belgium
Russian Federation
Denmark
Czech Republic
Taiwan
India
France
Slovakia
Argentina
Canada
Korea, Republic of
South Africa
Chile
Sweden
Netherlands
Singapore
Hungary
United States
Germany
United Kingdom
Italy
Brazil
Mexico
Spain
Turkey

location_facility:
sanofi-aventis Slovakia
sanofi-aventis Argentina
sanofi-aventis Taiwan
sanofi-aventis Russia
sanofi-aventis Turkey
sanofi-aventis Singapore
sanofi-aventis South Korea
sanofi-aventis Belgium
sanofi-aventis Canada
sanofi-aventis Finland
sanofi-aventis Spain
sanofi-aventis Italy
sanofi-aventis Denmark
sanofi-aventis South Africa
sanofi-aventis Chile
sanofi-aventis Netherlands
sanofi-aventis Germany
sanofi-aventis Mexico
sanofi-aventis UK
sanofi-aventis Sweden
sanofi-aventis Czech Republic
sanofi-aventis France
sanofi-aventis Brazil
sanofi-aventis US
Sanofi-Aventis Hungaria
sanofi-aventis India


title: International, Multicenter, Randomized, Parallel Group, Double-blind Study, in Patients With Acute Symptomatic Deep Vein Thrombosis of the Lower Limbs, Demonstrating the Bioequipotency at Steady State of Equimolar Doses of SSR126517E (3.0 mg) Once a Week and SR34006 (2.5 mg) Once a Week, Documenting the Safety and Efficacy of Both Compounds During a 6-month Treatment, and Demonstrating the Neutralizing Effect of SSR29261 on the SSR126517E-induced Anti-Xa Activity

acronym: EQUINOX

summary:
The three purposes of this study are the following:

To compare during a 6-month treatment the safety and effectiveness of idrabiotaparinux (SSR126517) with that of idraparinux (SR34006), taking into account new events of deep venous thrombosis (DVT) and pulmonary embolism (PE), and bleeding risk;
To compare the activities of idrabiotaparinux and idraparinux directly in blood during and after a 6-month treatment;
To check the ability of avidin (SSR29261) to reverse the blood thinning activity of idrabiotaparinux at the end of a 6-month treatment period.

ReferenceCitation: Equinox Investigators. Efficacy and safety of once weekly subcutaneous idrabiotaparinux in the treatment of patients with symptomatic deep venous thrombosis. J Thromb Haemost. 2011 Jan;9(1):92-9. doi: 10.1111/j.1538-7836.2010.04100.x.

journal_name: Journal of Thrombosis and Haemostasis

evidence: open (via free pdf)

ReferenceCitation: Trellu M, Fau JB, Cortez P, Cheng S, Paty I, Boëlle E, Donat F, Sanderink GJ. Bioequipotency of idraparinux and idrabiotaparinux after once weekly dosing in healthy volunteers and patients treated for acute deep vein thrombosis. Br J Clin Pharmacol. 2013 May;75(5):1255-64. doi: 10.1111/bcp.12009.

name: Research and Development; Sanofi; Chilly-Mazarin; France

family: Trellu

full_name: Marc Trellu

given: Marc

family: Fau

full_name: Jean-Baptiste Fau

given: Jean-Baptiste

name: Research and Development; Sanofi; Montpellier; France

family: Cortez

full_name: Pierre Cortez

given: Pierre

name: Research nd Development; Sanofi-aventis; Bridgewater; NJ; USA

family: Cheng

full_name: Sue Cheng

given: Sue

family: Paty

full_name: Isabelle Paty

given: Isabelle

name: Research and Development; Sanofi; Antony; France

family: Boëlle

full_name: Emmanuelle Boëlle

given: Emmanuelle

family: Donat

full_name: François Donat

given: François

family: Sanderink

full_name: Ger-Jan Sanderink

given: Ger-Jan

journal_name: British Journal of Clinical Pharmacology

oa_host_type: repository

ReferenceCitation: Paty I, Trellu M, Destors JM, Cortez P, Boëlle E, Sanderink G. Reversibility of the anti-FXa activity of idrabiotaparinux (biotinylated idraparinux) by intravenous avidin infusion. J Thromb Haemost. 2010 Apr;8(4):722-9. doi: 10.1111/j.1538-7836.2010.03746.x. Epub 2010 Jan 17.

family: PATY

full_name: I. PATY

family: TRELLU

full_name: M. TRELLU

family: DESTORS

full_name: J.-M. DESTORS

family: CORTEZ

full_name: P. CORTEZ

given: P.

family: BOËLLE

full_name: E. BOËLLE

given: E.

family: SANDERINK

full_name: G. SANDERINK

location_country:
Italy
Austria
Brazil
South Africa
Mexico
Netherlands
Spain
France
Poland
Israel
Argentina
Australia
Belgium
New Zealand
Russian Federation
Denmark
United States
Czech Republic
Canada
Turkey

location_facility:
sanofi-aventis France
Sanofi-Aventis
sanofi-aventis Israel
sanofi-aventis Mexico
sanofi-aventis Turkey
Sanofi-aventis
sanofi-aventis, Netherlands


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Design Study to Evaluate the Efficacy and Safety of Teriflunomide in Reducing the Frequency of Relapses and Delaying the Accumulation of Physical Disability in Subjects With Multiple Sclerosis With Relapses

acronym: TEMSO

summary:
The primary objective was to determine the effect of teriflunomide on the frequency of relapses in patients with relapsing multiple sclerosis (MS).

Secondary objectives were:

to evaluate the effect of teriflunomide on the accumulation of disability as measured by Expanded Disability Status Scale [EDSS], the burden of disease as measured by Magnetic Resonance Imaging [MRI] and patient-reported fatigue;
to evaluate the safety and tolerability of teriflunomide.

ReferenceCitation: O'Connor P, Wolinsky JS, Confavreux C, Comi G, Kappos L, Olsson TP, Benzerdjeb H, Truffinet P, Wang L, Miller A, Freedman MS; TEMSO Trial Group. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med. 2011 Oct 6;365(14):1293-303. doi: 10.1056/NEJMoa1014656.

family: O'Connor

full_name: Paul O'Connor

given: Paul

family: Wolinsky

full_name: Jerry S. Wolinsky

given: Jerry S.

family: Confavreux

full_name: Christian Confavreux

given: Christian

family: Comi

full_name: Giancarlo Comi

given: Giancarlo

family: Kappos

full_name: Ludwig Kappos

given: Ludwig

family: Olsson

full_name: Tomas P. Olsson

given: Tomas P.

family: Benzerdjeb

full_name: Hadj Benzerdjeb

given: Hadj

family: Truffinet

full_name: Philippe Truffinet

given: Philippe

family: Wang

full_name: Lin Wang

given: Lin

family: Miller

full_name: Aaron Miller

given: Aaron

family: Freedman

full_name: Mark S. Freedman

given: Mark S.

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Randomized Trial of Oral Teriflunomide for Relapsing Multiple Sclerosis

ReferenceCitation: Comi G, Freedman MS, Meca-Lallana JE, Vermersch P, Kim BJ, Parajeles A, Edwards KR, Gold R, Korideck H, Chavin J, Poole EM, Coyle PK. Prior treatment status: impact on the efficacy and safety of teriflunomide in multiple sclerosis. BMC Neurol. 2020 Oct 6;20(1):364. doi: 10.1186/s12883-020-01937-4.

family: Meca-Lallana

full_name: José E. Meca-Lallana

given: José E.

family: Vermersch

full_name: Patrick Vermersch

given: Patrick

family: Kim

full_name: Byoung Joon Kim

given: Byoung Joon

family: Parajeles

full_name: Alexander Parajeles

given: Alexander

family: Edwards

full_name: Keith R. Edwards

given: Keith R.

family: Gold

full_name: Ralf Gold

given: Ralf

family: Korideck

full_name: Houari Korideck

given: Houari

ReferenceCitation: Freedman MS, Wolinsky JS, Comi G, Kappos L, Olsson TP, Miller AE, Thangavelu K, Benamor M, Truffinet P, O'Connor PW; TEMSO and TOWER Study Groups. The efficacy of teriflunomide in patients who received prior disease-modifying treatments: Subgroup analyses of the teriflunomide phase 3 TEMSO and TOWER studies. Mult Scler. 2018 Apr;24(4):535-539. doi: 10.1177/1352458517695468. Epub 2017 Mar 17.

name: University of Ottawa and The Ottawa Hospital Research Institute, The Ottawa Hospital, Ottawa, ON, Canada

name: Multiple Sclerosis Research Group and MRI-Analysis Center, McGovern Medical School, UTHealth, Houston, TX, USA

name: Department of Neurology, University Vita-Salute San Raffaele, Milan, Italy

name: Neurology and Department of Biomedicine, University Hospital Basel, Basel, Switzerland

name: Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden

name: The Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Icahn School of Medicine at Mount Sinai, New York, NY, USA

name: University of Toronto, Toronto, ON, Canada

ReferenceCitation: Miller AE, O'Connor P, Wolinsky JS, Confavreux C, Kappos L, Olsson TP, Truffinet P, Wang L, D'Castro L, Comi G, Freedman MS; Teriflunomide Multiple Sclerosis Trial Group. Pre-specified subgroup analyses of a placebo-controlled phase III trial (TEMSO) of oral teriflunomide in relapsing multiple sclerosis. Mult Scler. 2012 Nov;18(11):1625-32. doi: 10.1177/1352458512450354. Epub 2012 Jun 21.

name: University of Texas Health Science Center, USA

name: University Claude Bernard Lyon 1, France

name: University Vita-Salute San Raffaele, Italy

name: for the Teriflunomide Multiple Sclerosis Trial Group

location_country:
Finland
Russian Federation
Denmark
Czech Republic
Ukraine
Estonia
France
Poland
Norway
Canada
Chile
Sweden
Switzerland
Netherlands
Portugal
Germany
United Kingdom
United States
Italy
Austria
Turkey

location_facility:
sanofi-aventis France
Sanofi-Aventis
sanofi-aventis Finland
sanofi-aventis, Canada
Sanofi-Aventis Austria
sanofi-aventis Poland
Sanofi-Aventis Administrative Office
sanofi-aventis Turkey
sanofi-aventis UK
Sanofi-Aventis Switzerland
sanofi-aventis Denmark
Sanofi-Aventis Deutschland GmbH


title: A Randomized Dose Ranging Study of Hexadecasaccharide Including Active Control, in Patients With Unstable Angina or Non-ST-Segment Elevation Myocardial Infarction Scheduled to Undergo Percutaneous Coronary Intervention (SHINE)

acronym: SHINE

summary: The purpose of this study is to test whether SR123781A is a possible treatment for patients with acute coronary syndromes (heart attack) who are scheduled to undergo a percutaneous coronary intervention (PCI) within 48 hours after inclusion in the study. Two doses of SR123781A are currently tested, each in a group of about 180 patients per group to find which is the most adequate, versus heparin and glycoprotein IIbIIIa (GPIIBIIIA) antagonist.

lead_sponsor: Sanofi

location_country:
Brazil
Chile
India
Mexico
Netherlands
Spain
France
Korea, Republic of
Poland
Belgium
Argentina
Australia
Portugal
Russian Federation
Turkey
United States
Czech Republic
Canada

location_facility:
Sanofi-Aventis
Sanofi-aventis
Sanofi-Aventis France


title: LIVACOR Trial: Minimally Invasive LIVer And Simultaneous COlorectal Resection

acronym: LIVACOR

summary: The LIVACOR - Trial is a European wide, randomized controlled, open-label, multicenter trial. Patients with synchronous colorectal liver metastases (CRLMs) and primary colorectal tumor are considered eligible and will be randomized between minimally invasive (MI) combined or staged colorectal resection (all colectomies, including high anterior resection) and liver resection of up to three segments.

ReferenceCitation: van der Poel MJ, Tanis PJ, Marsman HA, Rijken AM, Gertsen EC, Ovaere S, Gerhards MF, Besselink MG, D'Hondt M, Gobardhan PD. Laparoscopic combined resection of liver metastases and colorectal cancer: a multicenter, case-matched study using propensity scores. Surg Endosc. 2019 Apr;33(4):1124-1130. doi: 10.1007/s00464-018-6371-1. Epub 2018 Aug 1.

ReferenceCitation: Pan L, Tong C, Fu S, Fang J, Gu Q, Wang S, Jiang Z, Juengpanich S, Cai X. Laparoscopic procedure is associated with lower morbidity for simultaneous resection of colorectal cancer and liver metastases: an updated meta-analysis. World J Surg Oncol. 2020 Sep 21;18(1):251. doi: 10.1186/s12957-020-02018-z.

ReferenceCitation: Boudjema K, Locher C, Sabbagh C, Ortega-Deballon P, Heyd B, Bachellier P, Métairie S, Paye F, Bourlier P, Adam R, Merdrignac A, Tual C, Le Pabic E, Sulpice L, Meunier B, Regimbeau JM, Bellissant E; METASYNC Study group. Simultaneous Versus Delayed Resection for Initially Resectable Synchronous Colorectal Cancer Liver Metastases: A Prospective, Open-label, Randomized, Controlled Trial. Ann Surg. 2021 Jan 1;273(1):49-56. doi: 10.1097/SLA.0000000000003848.

ReferenceCitation: Gavriilidis P, Sutcliffe RP, Hodson J, Marudanayagam R, Isaac J, Azoulay D, Roberts KJ. Simultaneous versus delayed hepatectomy for synchronous colorectal liver metastases: a systematic review and meta-analysis. HPB (Oxford). 2018 Jan;20(1):11-19. doi: 10.1016/j.hpb.2017.08.008. Epub 2017 Sep 7.

ipd_sharing: Undecided

lead_sponsor: Fondazione Poliambulanza Istituto Ospedaliero

location_country:
Italy
Luxembourg
Netherlands
France
Norway
Belgium
Russian Federation
Spain
Germany
United Kingdom

location_facility: Klinikum Saarbrücken, Klinik für Allgemein-, Viszeral- und Thoraxchirurgie, Chirurgische Onkologie

location_facility: University Hospital Birmingham NHS Foundation Trust

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Manchester University NHS Foundation Trust

location_facility: Liverpool University Hospitals NHS Foundation Trust

location_facility: Azienda Ospedaliero-Universitaria di Modena

location_facility: University of Navarrra Hospital (Clinica Universitaria)

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS


title: A Multicenter, Double-blind, Randomized, Parallel-group Study to Evaluate the Safety, Tolerability, and Efficacy of Once Daily Amlodipine/Valsartan 5/80 mg as Compared to Amlodipine/Valsartan 5/40 mg or to Amlodipine 5 mg Once Daily in Elderly Patients With Essential Hypertension Not Adequately Controlled After Four Weeks on Amlodipine 5 mg Once Daily

summary: To characterize the safety, tolerability, and efficacy profile of amlodipine/valsartan 5/80 mg as compared to amlodipine/valsartan 5/40 mg (with optional titration to 5/80 mg) and amlodipine 5 mg monotherapy in elderly patients (≥ 65 years of age) with essential hypertension. All three regimens are expected to be well tolerated.

location_country:
Italy
Sweden
Finland
France
Poland
Slovakia
Hungary
Spain
Germany
Czech Republic

location_facility:
Investigative site Slovakia
Investigative site Czech Republic
Novartis Investigative site
Investigative site Hungary
Investigative sites Czech Republic
Investigative site Italy
Investigative site Spain
Investigative site Czech Repbulic
Sites in Czech Republic
Investigative site France
Investigative site Germany
Investigative sites Czech Repbulic
Investigative site Sweden
Investigative site Poland
Investigative site Finland


title: Third Prospective, Observational, International, Multicenter Study on Mechanical Ventilation

acronym: ISMV

summary:
The objective of this study is to obtain a better understanding of the spectrum of use of mechanical ventilation in intensive care units:

Main analysis: To know the all-cause mortality rate in mechanically ventilated patients

Secondary analyses:

To know the current status of mechanical ventilation in the intensive care unit and determine the number and percentage of patients who are admitted to an intensive care unit and require mechanical ventilation.
To compare the results with prior data collected in previous observational studies (1998 and 2004)
Non-invasive positive pressure ventilation
Weaning
Use of adjuvant therapies as steroids or selective digestive decontamination
Sedation including prevalence of delirium in mechanically ventilated patients
Prediction of the duration of mechanical ventilation
Other

ReferenceCitation: Esteban A, Anzueto A, Frutos F, Alía I, Brochard L, Stewart TE, Benito S, Epstein SK, Apezteguía C, Nightingale P, Arroliga AC, Tobin MJ; Mechanical Ventilation International Study Group. Characteristics and outcomes in adult patients receiving mechanical ventilation: a 28-day international study. JAMA. 2002 Jan 16;287(3):345-55.

ReferenceCitation: Esteban A, Ferguson ND, Meade MO, Frutos-Vivar F, Apezteguia C, Brochard L, Raymondos K, Nin N, Hurtado J, Tomicic V, González M, Elizalde J, Nightingale P, Abroug F, Pelosi P, Arabi Y, Moreno R, Jibaja M, D'Empaire G, Sandi F, Matamis D, Montañez AM, Anzueto A; VENTILA Group. Evolution of mechanical ventilation in response to clinical research. Am J Respir Crit Care Med. 2008 Jan 15;177(2):170-7. Epub 2007 Oct 25. Review.

ReferenceCitation: Nin N, Muriel A, Peñuelas O, Brochard L, Lorente JA, Ferguson ND, Raymondos K, Ríos F, Violi DA, Thille AW, González M, Villagomez AJ, Hurtado J, Davies AR, Du B, Maggiore SM, Soto L, D'Empaire G, Matamis D, Abroug F, Moreno RP, Soares MA, Arabi Y, Sandi F, Jibaja M, Amin P, Koh Y, Kuiper MA, Bülow HH, Zeggwagh AA, Anzueto A, Sznajder JI, Esteban A; VENTILA Group. Severe hypercapnia and outcome of mechanically ventilated patients with moderate or severe acute respiratory distress syndrome. Intensive Care Med. 2017 Feb;43(2):200-208. doi: 10.1007/s00134-016-4611-1. Epub 2017 Jan 20.

family: Nin

full_name: Nicolas Nin

given: Nicolas

family: Muriel

full_name: Alfonso Muriel

given: Alfonso

family: Peñuelas

full_name: Oscar Peñuelas

given: Oscar

family: Brochard

full_name: Laurent Brochard

given: Laurent

family: Lorente

full_name: José Angel Lorente

given: José Angel

family: Ferguson

full_name: Niall D. Ferguson

given: Niall D.

family: Raymondos

full_name: Konstantinos Raymondos

given: Konstantinos

family: Ríos

full_name: Fernando Ríos

given: Fernando

family: Violi

full_name: Damian A. Violi

given: Damian A.

family: Thille

full_name: Arnaud W. Thille

given: Arnaud W.

family: González

full_name: Marco González

given: Marco

family: Villagomez

full_name: Asisclo J. Villagomez

given: Asisclo J.

family: Hurtado

full_name: Javier Hurtado

given: Javier

family: Davies

full_name: Andrew R. Davies

given: Andrew R.

family: Du

full_name: Bin Du

given: Bin

family: Maggiore

full_name: Salvatore M. Maggiore

given: Salvatore M.

family: Soto

full_name: Luis Soto

given: Luis

family: D’Empaire

full_name: Gabriel D’Empaire

given: Gabriel

family: Matamis

full_name: Dimitrios Matamis

given: Dimitrios

family: Abroug

full_name: Fekri Abroug

given: Fekri

family: Moreno

full_name: Rui P. Moreno

given: Rui P.

family: Soares

full_name: Marco Antonio Soares

given: Marco Antonio

family: Arabi

full_name: Yaseen Arabi

repository_institution: RCAAP Project by FCT - Portuguese National Funding Agency for Science, Research and Technology - RCAAP Search Portal

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

repositories:
PubMed Central
dnet
repositorio.chlc.min-saude.pt

ReferenceCitation: Esteban A, Frutos-Vivar F, Muriel A, Ferguson ND, Peñuelas O, Abraira V, Raymondos K, Rios F, Nin N, Apezteguía C, Violi DA, Thille AW, Brochard L, González M, Villagomez AJ, Hurtado J, Davies AR, Du B, Maggiore SM, Pelosi P, Soto L, Tomicic V, D'Empaire G, Matamis D, Abroug F, Moreno RP, Soares MA, Arabi Y, Sandi F, Jibaja M, Amin P, Koh Y, Kuiper MA, Bülow HH, Zeggwagh AA, Anzueto A. Evolution of mortality over time in patients receiving mechanical ventilation. Am J Respir Crit Care Med. 2013 Jul 15;188(2):220-30. doi: 10.1164/rccm.201212-2169OC.

journal_name: American Journal of Respiratory and Critical Care Medicine

title: Evolution of Mortality over Time in Patients Receiving Mechanical Ventilation

location_country:
Peru
Greece
Australia
Russian Federation
Denmark
Taiwan
Ecuador
India
Morocco
Spain
Uruguay
France
Japan
Panama
Poland
Argentina
Canada
Korea, Republic of
Colombia
Chile
Saudi Arabia
Netherlands
Vietnam
Hungary
Puerto Rico
China
Portugal
Germany
United States
Italy
Brazil
Mexico
Bolivia
Venezuela
Tunisia
Egypt
New Zealand
Turkey

location_facility: Ermstalklinik Staedtisches Krankenhaus Sindelfingen

location_facility: Fundación Hospital Universitario de Alcorcón

location_facility: Policlinico "Agostino Gemelli", Università Cattolica Del Sacro Cuore

location_facility: Fondazione IRCCS "Cà Grande" Ospedale Maggiore Policlinico, Università Di Milano

location_facility: Hospital Clinic-IDIBAPS (ICU medical & ICU respiratory)

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: Calcutta medical research institute (CMRI)

location_facility: Hospital Universitario de Nuevo León 'Dr. Eleuterio González'

location_facility: Hospital General de Jerez de la Frontera

location_facility: Samsung Medical Center, Sungkyunkwan University

location_facility: Clínica Privada de Especialidades de Villa María

location_facility: Hospital Fattouma Bourguina (ICU medical & ICU surgical)

location_facility: Ospedale Policlinico, Università Di Bari

location_facility: Hospital General de Agudos Dalmacio Vélez Sársfield

location_facility: Clínica Medellín & Universidad Pontificia Bolivariana

location_facility: Karol Marcinkowski University Of Medical Sciences

location_facility: Charité Universitaetsklinikum (ICU medical-surgical & ICU other)

location_facility: Medical Faculty of Yuzuncu Yil University

location_facility: Centre Hospitalier de Châlons en Champagne

location_facility: Hospital Universitario Doctor Josep Trueta

location_facility: Hospital General de Agudos Juan A. Fernandez

location_facility: Chongqing Medical University 1st Hospital

location_facility: University of Iowa Hospitals and Clinics

location_facility: Hospital Universitário da Universidade Federal de Juiz de Fora

location_facility: Hospital Pusan National University of Yangsan

location_facility: King Saud Bin Abdulaziz University for Health Sciences

location_facility: Ospedale Policlinico "Federico II", Università Di Napoli

location_facility: Vanderbilt University School Of Medicine

location_facility: Hospital Chuncheon Sacred Heart Hospital, Hallym University Medical Center

location_facility: Complejo Hospitalario de Santiago de Compostela

location_facility: Hospital de SOLCA (ICU medical surgical & ICU medical)

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Santa Casa de Misericórdia de Ouro Preto

location_facility: Centro Hospitalar Trás-Os-Montes E Alto Douro

location_facility: Hospital Interzonal de Agudos San Martin

location_facility: University Of Texas Medical Branch at Galveston

location_facility: Universitaetsklinikum Bonn (ICU medical-surgical & ICU surgical)

location_facility: Policlinico "P. Giaccone", Università Di Palermo

location_facility: Ospedale Maggiore Della Carità, Università Del Piemonte Orientale "Amedeo Avogadro"

location_facility: Vrije Universiteit Medisch Centrum (VUMC) (Three units)

location_facility: University of Louisville School of Medicine

location_facility: Hospital General de Agudos Bernardino Rivadavia

location_facility: Universitaetsklinikum der Martin-Luther-Universitaet Halle-Wittenberg

location_facility: Policlinico Universitario "S. Orsola-Malpighi"

location_facility: Umae Hospital De Especialidades Dr. Antonio Fraga Mouret

location_facility: Hospital Severance, Yonsei University Health System

location_facility: University Hospital San Antonio and South Texas Veterans Health Care System

location_facility: Staedtisches Krankenhaus Martha-Maria Halle-Doelau gGmbH

location_facility: Hospital Interzonal General de Agudo Profesor Dr .Luis Guemes

location_facility: Evangelisches Krankenhaus Elisabethenstift gGmbH

location_facility: Hospital Regional de Alta Especialidad de la Mujer

location_facility: Fondazione IRCCS Policlinico "S. Matteo", Università Di Pavia (ICU 1 & ICU 2)

location_facility: Evangelisches Waldkrankenhaus Bad Godesberg gGmbH

location_facility: Hospital de Pronto Socorro Risoleta Tolentino Neves

location_facility: Ospedale "Arnas Civico, Di Cristina, Benfratelli"

location_facility: Instituto Português de Oncología Francisco Gentil

location_facility: Bombay Hospital Institute of Medical Sciences

location_facility: Hospital Universitario, Universidad Abierta Interamericana

location_facility: Centro Hospitalar Do Porto - Hospital Geral De Santo António

location_facility: Hospital General de Agudos donación Francisco Santojanni

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Hôpital Militaire D'Instruction Mohamed V

location_facility: Instituto Nacional De Ciencias Médicas y Nutrición Salvador Zubirán

location_facility: Hospital de Santo Antonio dos Capuchos, Centro Hospitalar de Lisboa Central, E.P.E.

location_facility: Katholische Stiftung Marienhospital Aachen

location_facility: Hospital Yonsei University Wonju Christian

location_facility: Ospedale "San Giovanni Battista - Molinette", Università Di Torino

location_facility: Policlinico "Umberto I", Università La Sapienza

location_facility: National Institute Of Surgery Named After A.V. Vishnevskij

location_facility: Grupo Cimca Hospital de San José (medical ICU)

location_facility: Asan Medical Center, University of Ulsan

location_facility: Oklahoma University Health Science Center & VA medical Center

location_facility: Ospedale "San Gerardo", Università Di Milano Bicocca


title: A Randomised,Double Blind, Placebo Controlled, Multicentre Trial of Abagovomab Maintenance Therapy in Patients With Epithelial Ovarian Cancer After Complete Response to First Line Chemotherapy

acronym: MIMOSA

summary: The purpose of this study is to evaluate the benefit of vaccination with Abagovomab, an experimental immunotherapy in ovarian cancer patients. The benefit will be evaluated in terms of time the remission status is kept as well as prolongation of life expectancy.

ReferenceCitation: Reinartz S, Köhler S, Schlebusch H, Krista K, Giffels P, Renke K, Huober J, Möbus V, Kreienberg R, DuBois A, Sabbatini P, Wagner U. Vaccination of patients with advanced ovarian carcinoma with the anti-idiotype ACA125: immunological response and survival (phase Ib/II). Clin Cancer Res. 2004 Mar 1;10(5):1580-7.

ReferenceCitation: Wagner U, Köhler S, Reinartz S, Giffels P, Huober J, Renke K, Schlebusch H, Biersack HJ, Möbus V, Kreienberg R, Bauknecht T, Krebs D, Wallwiener D. Immunological consolidation of ovarian carcinoma recurrences with monoclonal anti-idiotype antibody ACA125: immune responses and survival in palliative treatment. See The biology behind: K. A. Foon and M. Bhattacharya-Chatterjee, Are solid tumor anti-idiotype vaccines ready for prime time? Clin. Cancer Res., 7:1112-1115, 2001. Clin Cancer Res. 2001 May;7(5):1154-62.

ReferenceCitation: Pfisterer J, du Bois A, Sehouli J, Loibl S, Reinartz S, Reuss A, Canzler U, Belau A, Jackisch C, Kimmig R, Wollschlaeger K, Heilmann V, Hilpert F. The anti-idiotypic antibody abagovomab in patients with recurrent ovarian cancer. A phase I trial of the AGO-OVAR. Ann Oncol. 2006 Oct;17(10):1568-77.

ReferenceCitation: Sabbatini P, Dupont J, Aghajanian C, Derosa F, Poynor E, Anderson S, Hensley M, Livingston P, Iasonos A, Spriggs D, McGuire W, Reinartz S, Schneider S, Grande C, Lele S, Rodabaugh K, Kepner J, Ferrone S, Odunsi K. Phase I study of abagovomab in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer. Clin Cancer Res. 2006 Sep 15;12(18):5503-10.

ReferenceCitation: Buzzonetti A, Fossati M, Catzola V, Scambia G, Fattorossi A, Battaglia A. Immunological response induced by abagovomab as a maintenance therapy in patients with epithelial ovarian cancer: relationship with survival-a substudy of the MIMOSA trial. Cancer Immunol Immunother. 2014 Oct;63(10):1037-45. doi: 10.1007/s00262-014-1569-0. Epub 2014 Jun 21.

family: Buzzonetti

full_name: Alexia Buzzonetti

given: Alexia

family: Fossati

full_name: Marco Fossati

family: Catzola

full_name: Valentina Catzola

given: Valentina

family: Scambia

full_name: Giovanni Scambia

given: Giovanni

family: Fattorossi

full_name: Andrea Fattorossi

given: Andrea

family: Battaglia

full_name: Alessandra Battaglia

given: Alessandra

journal_name: Cancer Immunology, Immunotherapy

title: Immunological response induced by abagovomab as a maintenance therapy in patients with epithelial ovarian cancer: relationship with survival—a substudy of the MIMOSA trial

ReferenceCitation: Sabbatini P, Harter P, Scambia G, Sehouli J, Meier W, Wimberger P, Baumann KH, Kurzeder C, Schmalfeldt B, Cibula D, Bidzinski M, Casado A, Martoni A, Colombo N, Holloway RW, Selvaggi L, Li A, del Campo J, Cwiertka K, Pinter T, Vermorken JB, Pujade-Lauraine E, Scartoni S, Bertolotti M, Simonelli C, Capriati A, Maggi CA, Berek JS, Pfisterer J. Abagovomab as maintenance therapy in patients with epithelial ovarian cancer: a phase III trial of the AGO OVAR, COGI, GINECO, and GEICO--the MIMOSA study. J Clin Oncol. 2013 Apr 20;31(12):1554-61. doi: 10.1200/JCO.2012.46.4057. Epub 2013 Mar 11.

name: Paul Sabbatini, Memorial Sloan-Kettering Cancer Center, New York, NY; Philipp Harter, Kliniken Essen-Mitte; Pauline Wimberger, Universitaetsklinikum Essen, Essen; Jalid Sehouli, Charité-Campus Virchow Klinikum, Berlin; Werner Meier, Evangelisches Krankenhaus, Dusseldorf; Klaus H. Baumann, Universitätsklinikum Gießen und Marburg, Marburg; Christian Kurzeder, Klinikum der Universität Ulm, Frauenklinik und Poliklinik, Ulm; Barbara Schmalfeldt, Klinikum Rechts der Isar der Technischen Universität München,...

family: Sabbatini

full_name: Paul Sabbatini

given: Paul

family: Harter

full_name: Philipp Harter

given: Philipp

family: Sehouli

full_name: Jalid Sehouli

given: Jalid

family: Meier

full_name: Werner Meier

given: Werner

family: Wimberger

full_name: Pauline Wimberger

given: Pauline

family: Baumann

full_name: Klaus H. Baumann

given: Klaus H.

family: Kurzeder

full_name: Christian Kurzeder

given: Christian

family: Schmalfeldt

full_name: Barbara Schmalfeldt

given: Barbara

family: Cibula

full_name: David Cibula

given: David

family: Bidzinski

full_name: Mariusz Bidzinski

given: Mariusz

family: Casado

full_name: Antonio Casado

given: Antonio

family: Martoni

full_name: Andrea Martoni

publisher: American Society of Clinical Oncology (ASCO)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

publisher_group: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

title: Abagovomab As Maintenance Therapy in Patients With Epithelial Ovarian Cancer: A Phase III Trial of the AGO OVAR, COGI, GINECO, and GEICO—The MIMOSA Study

location_country:
Italy
United States
France
Poland
Hungary
Belgium
Spain
Germany
Czech Republic

location_facility: Klinikum der Stadt Wolfsburg-FrauenklinikWolfsburg

location_facility: Fővárosi Önkormányzat Szent Margit Kórháza, Onkológia

location_facility: Unità Operativa Ginecologia e Ostetricia 2^, Università degli studi di Bari, Policlinico

location_facility: Ospedale S. Orsola Malpighi, Oncologia Medica

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Azienda Ospedaliera - Universitaria Careggi

location_facility: Universtita' Cattolica del Sacro Cuore Dipartimento di Oncologia

location_facility: Martin-Luther-Universität Halle-Wittenberg, Klinikum der Medizinischen Fakultät

location_facility: Hospital Universitario Arnau de Vilanova, Servicio de Oncologia

location_facility: Semmelweis Egyetem II. sz. Szülészeti és Nőgyógyászati Klinika

location_facility: Azienda Ospedaliera San Carlo - Oncologia Medica

location_facility: Hospital Son Dureta, Servicio de Oncología

location_facility: Hospital Vall d'Hebrón, Servicio de Oncologia

location_facility: DH Oncologico U.O. Medicina Oncologica Ospedale Ramazzini

location_facility: Istituto Nazionale per lo studio e la cura dei tumori "Fondazione Pascale" Oncologia Medica

location_facility: Petz Aladar Megyei Oktató Kórház, Onkoradiológia

location_facility: Oddzial Chemioterapii ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie

location_facility: Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Kórháza, Szülészet-Nőgyógyászati Osztály

location_facility: Universitätsklinikum Schleswig-Holstein Campus Kiel

location_facility: Instituto Catalán de Oncología - Hospital Universitari de Girona "Dr. Josep Trueta". Oncologia Medica

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie, Klinika Nowotworów Narządów Płciowych Kobiecych

location_facility: Oncologia Medica Ospedale di Faenza - AUSL di Ravenna

location_facility: Klinika Onkologii, Oddzial Chemioterapii Akademii Medycznej w Poznaniu

location_facility: Ospedali Riuniti Bianchi-Melacrino-Morelli - Oncologia Medica

location_facility: SPZOZ Wojewodzki Szpital Specjalistyczny Nr 3, Oddzial Onkologii

location_facility: Universitair Ziekenhuis Gent Medische Oncologie 4B-Z

location_facility: Wojewodzkie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej

location_facility: Azienda Ospedaliera San Martino - Padiglione Malattie Complesse, Dipartimento di Oncologia Medica

location_facility: Policlinico di Modena, Dipartimento di Oncologia ed Ematologia

location_facility: University of California, Los Angeles (UCLA)

location_facility: Gynekologicko-porodnicka klinika FN Plzen

location_facility: AZ Sint Augustinus, Oncologisch Centrum GVA

location_facility: Hackensack University Medical Center, Obstetrics and Gynecology Oncology

location_facility: Semmelweis Egyetem, I sz. Szülészeti és Nőgyógyászati Klinika

location_facility: Hospital Clinico de Malaga. Servicio de Oncologia

location_facility: Policlinico Umberto I D.H. Oncologico Oncologia Medica

location_facility: Curtis and Elizabeth Anderson Cancer Institute

location_facility: Hospital General Universitario de Valencia

location_facility: Krajska nemocnice Liberec, oddeleni gynekologicko porodnicke

location_facility: Komárom-Esztergom Megyei Onkormanyzat Szent Borbála Kórház, Szülészet-Nőgyógyászati Osztály

location_facility: Hospital Clinic i Provincial de Barcelona, Servicio de Oncologia

location_facility: Oddzial Onkologii Wojewódzki Szpital Specjalistyczny

location_facility: Pécsi Tudományegyetem, ÁOK Szülészeti és Nőgyógyászati Klinika

location_facility: Klinikum der Universität München-Innenstadt

location_facility: Dipartimento di Ginecologia ed Ostetricia Policlinico Universitario Gemelli

location_facility: Hospital Clinico San Carlos, Servicio de Oncología Medica

location_facility: Centralny Szpital Kliniczny MSWiA, Klinika Onkologii, Hematologii i Chorob Wewnetrznych

location_facility: Ospedale Casa Sollievo della Sofferenza - Unita' Operativa di Ostetricia e Ginecologia

location_facility: Debreceni Egyetem Orvos és Egészségtudományi Centrum, Szülészetl es Nőgyógyászatl Klinika

location_facility: Wojskowy Instytut Medyczny; Klinika Onkologii Centralnego Szpitala Klinicznego MON

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Klinikum Südstadt der Hansestadt Rostock

location_facility: Klinika Chemioterapii Nowotworów Akademii Medycznej w Łodzi, Regionalny Osrodek Onkologiczny

location_facility: Wojewodzki Szpital Zespolony, Oddzial Onkologii Klinicznej

location_facility: Istituto Europeo di Oncologia - Divisione di Ginecologia

location_facility: Dipartimento di Discipline Ginecologiche e Ostetriche - Universita degli Studi di Torino - Azienda ospedaliera O.I.R.M.-S'Anna

location_facility: Harry and Jeanette Weinberg Cancer Institute at Franklin Square

location_facility: Arcispedale Santa Maria Nuova, Oncologia Medica

location_facility: "Centrum Onkologii, Instytut im. M. Skłodowskiej-Curie, Oddział w Krakowie,

location_facility: Klinikum der Stadt Villingen-Schwenningen GmbH

location_facility: Women and Infants Hospital of Rhode Island

location_facility: Centro Oncológico Regional de Galicia, Servicio de Oncologia Medica


title: Open-Label Study to Determine How Prior Therapy With Alendronate or Risedronate in Postmenopausal Women With Osteoporosis Influences the Clinical Effectiveness of Teriparatide

summary: To determine how prior therapy with alendronate or risedronate in postmenopausal women with osteoporosis influences the clinical effectiveness of teriparatide; The primary objective of the study is to compare the teriparatide (human, recombinant PTH[1-34])-associated change from baseline in a marker of bone formation, N-terminal propeptide of type I collagen (P1NP), between subjects previously treated with risedronate and those previously treated with alendronate.

ReferenceCitation: Miller PD, Delmas PD, Lindsay R, Watts NB, Luckey M, Adachi J, Saag K, Greenspan SL, Seeman E, Boonen S, Meeves S, Lang TF, Bilezikian JP; Open-label Study to Determine How Prior Therapy with Alendronate or Risedronate in Postmenopausal Women with Osteoporosis Influences the Clinical Effectiveness of Teriparatide Investigators. Early responsiveness of women with osteoporosis to teriparatide after therapy with alendronate or risedronate. J Clin Endocrinol Metab. 2008 Oct;93(10):3785-93. doi: 10.1210/jc.2008-0353. Epub 2008 Aug 5.

name: Colorado Center for Bone Research (P.D.M.), Lakewood, Colorado 80227

family: Miller

full_name: Paul D. Miller

given: Paul D.

name: Institut National de la Santé et de la Recherche Médicale Research Unit 831 (P.D.D.) and Claude Bernard University Lyon 1, 69372 Lyon, France

family: Delmas

full_name: Pierre D. Delmas

given: Pierre D.

name: Regional Bone Center (R.L.), Helen Hayes Hospital, West Haverstraw, New York 10993

family: Lindsay

full_name: Robert Lindsay

given: Robert

name: University of Cincinnati Bone Health and Osteoporosis Center (N.B.W.), Cincinnati, Ohio 45219

family: Watts

full_name: Nelson B. Watts

given: Nelson B.

name: St. Barnabas Osteoporosis Center (M.L.), Livingston, New Jersey 07039

family: Luckey

full_name: Marjorie Luckey

given: Marjorie

name: St. Joseph’s Healthcare (J.A.), McMaster University, Hamilton, Ontario, Canada L8S4L8

family: Adachi

full_name: Jonathan Adachi

given: Jonathan

name: Division of Clinical Immunology and Rheumatology (K.S.), University of Alabama at Birmingham, Birmingham, Alabama 35233

family: Saag

full_name: Kenneth Saag

given: Kenneth

name: University of Pittsburgh Medical Center (S.L.G.), Pittsburgh, Pennsylvania 15213

family: Greenspan

full_name: Susan L. Greenspan

given: Susan L.

name: Endocrinology Department (E.S.), Austin Health, University of Melbourne, Victoria 3010, Australia

family: Seeman

full_name: Ego Seeman

given: Ego

name: Bone Research Unit (S.B.), Leuven University, Department of Experimental Medicine, B-3000 Leuven, Belgium

family: Boonen

full_name: Steven Boonen

given: Steven

name: sanofi-aventis (S.M.), Bridgewater, New Jersey 08807

family: Meeves

full_name: Suzanne Meeves

given: Suzanne

name: Department of Radiology (T.F.L.), Center for Molecular and Functional Imaging, University of California at San Francisco, San Francisco, California 94107

family: Lang

full_name: Thomas F. Lang

given: Thomas F.

name: Division of Endocrinology (J.P.B.), Metabolic Bone Diseases Unit, Columbia University College of Physicians and Surgeons, New York, New York 10021

family: Bilezikian

full_name: John P. Bilezikian

given: John P.

name: for the Open-label Study to Determine How Prior Therapy with Alendronate or Risedronate in Postmenopausal Women with Osteoporosis Influences the Clinical Effectiveness of Teriparatide Investigators

journal_name: The Journal of Clinical Endocrinology & Metabolism

publisher: The Endocrine Society

publisher_dissemination: The Endocrine Society

publisher_group: The Endocrine Society

publisher_normalized: The Endocrine Society

title: Early Responsiveness of Women with Osteoporosis to Teriparatide After Therapy with Alendronate or Risedronate

location_country:
United States
Netherlands
France
Belgium
Australia
Canada
United Kingdom

location_facility:
sanofi-aventis, US
sanofi-aventis, Belgium
sanofi-aventis, France
sanofi-aventis, Canada
sanofi-aventis, Australia
sanofi-aventi, UK
sanofi-aventis, Netherlands


title: Randomized, Multicenter, Double-Blind, Placebo-Controlled, Two-Arm Parallel Group Trial of Rimonabant 20-mg od, for Inhibition of Atherosclerosis Progression Assessed by IVUS (IntraVascular UltraSounds), in Overweight Patients With Clustering Risk Factors

summary: The purpose of this study is to determine if rimonabant 20 mg once daily (od) administered during 18-20 months will reduce progression of coronary atherosclerosis as assessed by intravascular ultrasound (IVUS) when administered on top of standard behavioral and pharmacological therapy given as needed, in patients with abdominal obesity associated with current smoking and/or metabolic syndrome.

ReferenceCitation: Nissen SE, Nicholls SJ, Wolski K, Rodés-Cabau J, Cannon CP, Deanfield JE, Després JP, Kastelein JJ, Steinhubl SR, Kapadia S, Yasin M, Ruzyllo W, Gaudin C, Job B, Hu B, Bhatt DL, Lincoff AM, Tuzcu EM; STRADIVARIUS Investigators. Effect of rimonabant on progression of atherosclerosis in patients with abdominal obesity and coronary artery disease: the STRADIVARIUS randomized controlled trial. JAMA. 2008 Apr 2;299(13):1547-60. doi: 10.1001/jama.299.13.1547. Epub 2008 Apr 1.

family: Nissen

full_name: Steven E. Nissen

given: Steven E.

family: Nicholls

full_name: Stephen J. Nicholls

given: Stephen J.

family: Wolski

full_name: Kathy Wolski

given: Kathy

family: Rodés-Cabau

full_name: Josep Rodés-Cabau

given: Josep

family: Cannon

full_name: Christopher P. Cannon

given: Christopher P.

family: Deanfield

full_name: John E. Deanfield

given: John E.

family: Després

full_name: Jean-Pierre Després

given: Jean-Pierre

family: Kastelein

full_name: John J. P. Kastelein

given: John J. P.

family: Steinhubl

full_name: Steven R. Steinhubl

given: Steven R.

family: Kapadia

full_name: Samir Kapadia

given: Samir

family: Yasin

full_name: Muhammad Yasin

given: Muhammad

family: Ruzyllo

full_name: Witold Ruzyllo

given: Witold

family: Gaudin

full_name: Christophe Gaudin

given: Christophe

family: Job

full_name: Bernard Job

given: Bernard

family: Hu

full_name: Bo Hu

given: Bo

family: Bhatt

full_name: Deepak L. Bhatt

given: Deepak L.

family: Lincoff

full_name: A. Michael Lincoff

given: A. Michael

family: Tuzcu

full_name: E. Murat Tuzcu

given: E. Murat

family: STRADIVARIUS Investigators

full_name: for the STRADIVARIUS Investigators

given: for the

journal_name: JAMA

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

title: Effect of Rimonabant on Progression of Atherosclerosis in Patients With Abdominal Obesity and Coronary Artery Disease

location_country:
Italy
United States
Netherlands
France
Poland
Belgium
Australia
Spain
Canada

location_facility:
sanofi-aventis, Belgium
sanofi-aventis, France
The Cleveland Clinic Foundation
sanofi-aventis Spain
Sanofi-Aventis Administrative Office
sanofi-aventis, Australia
sanofi-aventis Italy
sanofi-aventis Poland
sanofi-aventis, Netherlands


title: A 24-week, Double Blind, Randomized Study to Investigate the Effect of 500 µg Roflumilast Tablets Once Daily Versus Placebo on Parameters Indicative of Hyperinflation in Patients With Chronic Obstructive Pulmonary Disease

summary: The purpose of this trial is to study the effects of roflumilast on lung function parameters indicative of hyperinflation in patients with COPD.

location_country:
South Africa
France
Poland
Spain
United States
United Kingdom
Canada


title: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. A 52-week, Multicenter, Double-blind Study With 500 mcg Roflumilast Once Daily Versus Placebo.

summary: The purpose of this study is to determine whether roflumilast is effective in the treatment of exacerbations in patients with chronic obstructive pulmonary disease (COPD).

ReferenceCitation: Facius A, Krause A, Claret L, Bruno R, Lahu G. Modeling and Simulation of Pivotal Clinical Trials Using Linked Models for Multiple Endpoints in Chronic Obstructive Pulmonary Disease With Roflumilast. J Clin Pharmacol. 2017 Aug;57(8):1042-1052. doi: 10.1002/jcph.885. Epub 2017 Apr 17.

name: Takeda Pharmaceuticals International GmbH; Glattpark-Opfikon (Zürich) Switzerland

family: Facius

full_name: Axel Facius

given: Axel

name: Pharsight Consulting Services; Pharsight, a Certara Company; Mountain View CA USA

family: Krause

full_name: Andreas Krause

given: Andreas

family: Claret

full_name: Laurent Claret

given: Laurent

family: Bruno

full_name: Rene Bruno

given: Rene

family: Lahu

full_name: Gezim Lahu

given: Gezim

ReferenceCitation: Rennard SI, Calverley PM, Goehring UM, Bredenbröker D, Martinez FJ. Reduction of exacerbations by the PDE4 inhibitor roflumilast--the importance of defining different subsets of patients with COPD. Respir Res. 2011 Jan 27;12:18. doi: 10.1186/1465-9921-12-18.

family: Rennard

full_name: Stephen I Rennard

given: Stephen I

family: Calverley

full_name: Peter MA Calverley

given: Peter MA

family: Goehring

full_name: Udo M Goehring

given: Udo M

family: Bredenbröker

full_name: Dirk Bredenbröker

given: Dirk

family: Martinez

full_name: Fernando J Martinez

given: Fernando J

title: Reduction of exacerbations by the PDE4 inhibitor roflumilast - the importance of defining different subsets of patients with COPD

location_country:
United States
South Africa
France
Poland
Germany
Canada


title: Efficacy and Safety of Aflibercept in Combination With FOLFIRI Chemotherapy as 1st Line Treatment for Patients With Metastatic Colorectal Cancer

summary:
One of the treatments generally used to treat this disease is a chemotherapy called FOLFIRI. The purpose of this study is to improve the efficacy of the chemotherapy by adding a protein, similar to immunoglobulins, aflibercept, and to assess their tolerance.

Aflibercept is a protein that has already been studied in the treatment of metastatic colorectal cancers, in combination with a chemotherapy involving irinotecan in addition to 5FU (fluoropyrimidine) ( (FOLFIRI) as 2nd line treatment. It is marketed in Europe and it is authorized in the United States. Its addition to this chemotherapy combination has in fact brought about a benefit in terms of progression-free survival and overall survival.

The purpose of the study is to evaluate the efficacy and tolerance of this combination rather in the initial approach to the treatment of metastatic colorectal cancers and hence to evaluate it as 1st line treatment

ReferenceCitation: Lapeyre-Prost A, Pernot S, Sigrand J, Le Malicot K, Mary F, Aparicio T, Dahan L, Caroli-Bosc FX, Lecomte T, Doat S, Marthey L, Desrame J, Lepage C, Taieb J. Aflibercept in Combination With FOLFIRI as First-line Chemotherapy in Patients With Metastatic Colorectal Cancer (mCRC): A Phase II Study (FFCD 1302). Clin Colorectal Cancer. 2020 Dec;19(4):285-290. doi: 10.1016/j.clcc.2020.06.003. Epub 2020 Jun 12.

family: Lapeyre-Prost

full_name: Alexandra Lapeyre-Prost

given: Alexandra

family: Pernot

full_name: Simon Pernot

given: Simon

family: Sigrand

full_name: Julie Sigrand

given: Julie

family: Le Malicot

full_name: Karine Le Malicot

given: Karine

family: Mary

full_name: Florence Mary

given: Florence

family: Aparicio

full_name: Thomas Aparicio

given: Thomas

family: Dahan

full_name: Laetitia Dahan

given: Laetitia

family: Caroli-Bosc

full_name: François-Xavier Caroli-Bosc

given: François-Xavier

family: Lecomte

full_name: Thierry Lecomte

given: Thierry

family: Doat

full_name: Solène Doat

given: Solène

family: Marthey

full_name: Lysianne Marthey

given: Lysianne

family: Desrame

full_name: Jérôme Desrame

given: Jérôme

family: Lepage

full_name: Come Lepage

given: Come

family: Taieb

full_name: Julien Taieb

given: Julien

journal_name: Clinical Colorectal Cancer

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: Hôpital Européen Geaorge Pompidou (HEGP)


title: A Randomized, Cross-over Study to Compare Quality of Life and Satisfaction in Primary Immunodeficient Patients Treated With Subcutaneous Injections of Gammanorm® 165 mg/mL According to the Delivery Device: Injections Using Pump or Rapid Push.

summary: The purpose of this study is to compare satisfaction (LQI questionnaire, factor I: treatment interference) in PID patients receiving subcutaneous injections of Gammanorm® 165 mg/mL according to the delivery device.

ReferenceCitation: Bienvenu B, Cozon G, Mataix Y, Lachaud D, Alix A, Hoarau C, Antier D, Hachulla E, Brice S, Viallard JF, Tamisier S, Fauchais AL, Renon-Carron F, Clerson P, Fardini Y, Crave JC, Miossec P. Rapid Push vs Pump-Infused Subcutaneous Immunoglobulin Treatment: a Randomized Crossover Study of Quality of Life in Primary Immunodeficiency Patients. J Clin Immunol. 2018 May;38(4):503-512. doi: 10.1007/s10875-018-0507-x. Epub 2018 May 31.

family: Bienvenu

full_name: Boris Bienvenu

given: Boris

family: Cozon

full_name: Grégoire Cozon

given: Grégoire

family: Mataix

full_name: Yves Mataix

given: Yves

family: Lachaud

full_name: Dominique Lachaud

given: Dominique

family: Alix

full_name: Antoine Alix

given: Antoine

family: Hoarau

full_name: Cyrille Hoarau

given: Cyrille

family: Antier

full_name: Daniel Antier

given: Daniel

family: Hachulla

full_name: Eric Hachulla

given: Eric

family: Brice

full_name: Sylvie Brice

given: Sylvie

family: Viallard

full_name: Jean-François Viallard

given: Jean-François

family: Tamisier

full_name: Stéphanie Tamisier

given: Stéphanie

family: Fauchais

full_name: Anne-Laure Fauchais

given: Anne-Laure

family: Renon-Carron

full_name: Françoise Renon-Carron

given: Françoise

family: Clerson

full_name: Pierre Clerson

given: Pierre

family: Fardini

full_name: Yann Fardini

given: Yann

family: Crave

full_name: Jean-Charles Crave

given: Jean-Charles

family: Miossec

full_name: Pierre Miossec

journal_name: Journal of Clinical Immunology

publisher_dissemination: Springer-Nature

location_facility:
University Hospital of Lille
Haut-Leveque Hospital
University Hospital of Caen
University Hospital of Toulouse
Clinique Mutualiste
University Hospital of Reims
University Hospital of Tours
Hospital Dupuytren


title: Vibration Response Imaging (VRI) in Patients That Are Undergoing Pulmonary Interventional Procedure

summary:
Vibration response imaging (VRI) technology, provides a radiation-free dynamic image of the lung, by visualizing vibration energy emitted during the respiration cycle (lung sounds). Airflow in the lungs during the respiration cycle creates vibrations that propagate through the lung tissue; these vibrations are affected by the structural properties of the lungs and may vary in space, time and frequency. Moreover, any structural alteration, such as a bronchial obstruction or space occupying infiltration, is reflected in a corresponding modification of the vibration response.

As obstructions that occur in airways alter airflow, the VRI may provide additional lung function information prior to treatment for airway obstruction and during follow-up. Moreover, the VRI may provide the physician immediate evaluation of the improvement of air flow distribution, quantitative and qualitative measurements. Furthermore, the VRI is a non-invasive, radiation free procedure which is simple and doesn't require the level of patient effort required for lung function test and other evaluation.

ReferenceCitation: Dellinger RP, Parrillo JE, Kushnir A, Rossi M, Kushnir I. Dynamic visualization of lung sounds with a vibration response device: a case series. Respiration. 2008;75(1):60-72. Epub 2007 Jun 4.

ReferenceCitation: Ernst A, Feller-Kopman D, Becker HD, Mehta AC. Central airway obstruction. Am J Respir Crit Care Med. 2004 Jun 15;169(12):1278-97. Review.

lead_sponsor: Deep Breeze

location_country:
Germany
United States
France
Japan

location_facility: National Jewish Medical and Research Center


title: A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Trial Using CD133 Enriched Bone Marrow Cells Following Primary Angioplasty for Acute Myocardial Infarction

acronym: SELECT-AMI

summary: An international, multi-centre, double-blind, randomised, placebo-controlled clinical trial with central core lab analyses to determine the safety of intra-coronary infusion of enriched CD133+, bone marrow-derived, autologous progenitor cells in patients 5-10 days after acute percutaneous coronary revascularization (primary PCI) for ST-segment elevation myocardial infarction (STEMI).

lead_sponsor: Jozef Bartunek

location_country:
United Kingdom
Belgium
France
Netherlands

location_facility:
Catharina Ziekenhuis
King's College University Hospital
Hôpital Cardiologique
CHU ST-Pierre
OLVZ Aalst