acronym: COTTONWOOD

title: An Open-Label Extension and Safety Monitoring Study of Moderate to Severe Ulcerative Colitis Patients Previously Enrolled in Etrolizumab Phase II/III Studies

ReferenceCitation: Sandborn WJ, Vermeire S, Tyrrell H, Hassanali A, Lacey S, Tole S, Tatro AR; Etrolizumab Global Steering Committee. Etrolizumab for the Treatment of Ulcerative Colitis and Crohn's Disease: An Overview of the Phase 3 Clinical Program. Adv Ther. 2020 Jul;37(7):3417-3431. doi: 10.1007/s12325-020-01366-2. Epub 2020 May 22.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Belgium
Romania
South Africa
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Norway
Malaysia
Singapore
Slovakia
Brazil
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
Greece
Latvia
Estonia
New Zealand
Korea, Republic of
France
Colombia
Netherlands

location_facility: Innovative Medical Research of South Florida, Inc.

location_facility: University of North Carolina at Chapel Hill

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely

location_facility: FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the MoD of the RF; Therapy

location_facility: SBEI of HPE "Omsk SMA" Ministry of healthcare of RF"

location_facility: University Hospital - London Health Sciences Centre

location_facility: Royal Melbourne Hospital; Department of Colorectal Medicine and Genetics

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Cotton-O'Neil Clinical Research Center, Digestive Health

location_facility: SBEI HPE "Voronezh State Medical University n.a. N.N. Burdenko" of the MoH of the RF

location_facility: Gastroenterology Center of the Midsouth, P.C.

location_facility: University of Chicago Medical Center; Medicine, Section of Pulmonary

location_facility: Fundacion Hospital de Alcorcon; Servicio de Digestivo

location_facility: Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH

location_facility: CHA Bundang Medical Centre; CHA university

location_facility: Atlanta Gastroenterology Specialists, PC

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Hospital Universitari de Girona Dr Josep Trueta

location_facility: CI UDH Dept of Ther SHEI Fac of PGE&Pre-Univ Training

location_facility: RCI Chernivtsi RCH Gastroenterology Bukovinsky SMU

location_facility: Centro Integral en Reumatología S.A. de C.V. (CIRSA)

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

location_facility: Gemeinschaftspraxis Dres. Joachim Mueller und Steffi Appelt

location_facility: Vilnius University Hospital Santariskiu Clinic, Public Institution; Cardiology

location_facility: UC Health Clinical Trials Office; Division of Digestive Diseases

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

location_facility: Seoul National University Bundang Hospital

location_facility: Keimyung University Dongsan Medical Center

location_facility: CI Kherson Afanasii and Olha Tropiny City Clinical Hospital

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: LLC International Medical Centre "SOGAZ"

location_facility: Specjalistyczna Praktyka Lekarska Dr med. Marek Horynski; endoskopia

location_facility: Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)

location_facility: S. R. Kalla Memorial Gastro & General Hospital

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta

location_facility: FSBI "State Scientific Centre of Coloproctology" of the MoH of RF; Gastroenterology

location_facility: Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"

location_facility: Hamburgisches Forschungsinstitut fuer CED

location_facility: King Edward Memorial Hospital Research Centre

location_facility: GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine

location_facility: FFSBI "The Nikiforov Russian Center of Emergency and Radiation Medicine"; Pulmonology

location_facility: GZA Ziekenhuizen - Campus Sint-Vincentius

location_facility: Fondazione Poliambulanza Istituto Ospedaliero

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh

location_facility: Cliniques Universitaires Saint-Luc; Pharmacy

location_facility: Pusat Perubatan Universiti Kebangsaan Malaysia

location_facility: M.V. Sklifosovskyi Poltava RCH Dept of Gastroenterology HSEIU UMSA

location_facility: Texas Digestive Disease Consultants - Southlake

location_facility: Gastroenterology Associates of Central Georgia

location_facility: K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre

location_facility: Medical Center of Limited Liability Company Medical Clinic Blagomed

location_facility: M.V. Sklifosovskyi Poltava RCH Outpatient UMSA HSEIU Ukrainian Medical Stomatological Academy

location_facility: CI of Kyiv RC Regional Clinical Hospital #2

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León

location_facility: Phylasis Clinicas Research S de RL de CV

location_facility: Asheville Gastroenterology Associates, P.A.

location_facility: SBHI of NN region "RCH of NN n.a. N.A.Semashko"

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital Universitario Prof Edgar Santos-Ufba; Ambulatorio Magalhaes Neto 3Andar- Dermatologia

location_facility: CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC

location_facility: Centre de santé et de services sociaux Champlain-Charles-Le Moyne

location_facility: UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

location_facility: Northwestern University Feinberg School Of Medicine

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

location_facility: Deccan College of Medical Sciences and Allied Hospitals; Department of Gastroenterology

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Pauls Stradins Clinical University Hospital

location_facility: University of California, Irvine Medical Center

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: Gazi University Medical Faculty; Gastroenterology

location_facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte

location_facility: Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital

location_facility: Uniwersyteckie Centrum Kliniczne im. prof. K. Gibinskiego SUM

location_facility: CI of SRC Sumy RCH Dept of Gasroenterology Sumy SU MI

location_facility: Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie

location_facility: Hospital Raja Perempuan Zainab II; Department of Medicine

location_facility: Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: Rigshospitalet; Medicinsk gastroenterologisk klinik

location_facility: CI of Kyiv RC Kyiv Regional Clinical Hospital

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: Queen Elizabeth II Health Sciences Centre; Gastroenterology Research

location_facility: Oblastni nemocnice Kladno, a.s., nemocnice Stredoces. kraje; Endoskopicke centrum

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

location_facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Diagnostic Consultation Center CONVEX EOOD

location_facility: Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital

location_facility: Hospital da Senhora da Oliveira Guimarães

location_facility: SBEI HPE Altai StateMedicalUniversityofMoH andSD

location_facility: Nottingham University Hospitals; QMC Campus

location_facility: Texas Digestive Disease Consultants - Dallas

location_facility: Fakultni nemocnice u sv. Anny v Brne; I.Interni kardioangiologicka klinika

location_facility: Medical Center "Nov Rehabilitatsionen Tsentar", EOOD

location_facility: SI Dnipropetrovsk MA of MOHU SI Institute of gastroenterology of AMSU

location_facility: FSBEI HE "Stavropol State Medical University" of Ministry of Healthcare of Russian Federation

location_facility: 7 Szpital Marynarki Wojennej z Przychodnia SPZOZ im. W. Lasinskiego

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Rocky Mountain Gastroenterology Associates

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: Wojewodzki Specjalistyczny Szpital w Olsztynie

location_facility: Stavropol Regional Clinical Diagnostic Consultative Center

location_facility: BHI of Omsk region Clinical Oncology Dispensary

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej SONOMED

location_facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda

location_facility: Klinikum Mannheim GmbH Universitätsklinikum

location_facility: West Central Gastroenterology d/b/a Gastro Florida

location_facility: M. S. Ramaiah Medical College and Hospital

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Zespó Przychodni Specjalistycznych PRIMA

location_facility: Kocaeli Universitesi Tip Fakultesi; Infectious Diseases

location_facility: DCC Sv. Pantaleymon OOD; II-nd Clinic of Neurology

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner

location_facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

location_facility: Hospital Universitario Walter Cantidio - UFC

location_facility: M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU

location_facility: Hospital do Servidor Público Estadual/HSPE-SP

location_facility: Markhot Ferenc Oktato Korhaz es Rendelointezet

location_facility: MHAT 'Sv. Marina', EAD; First Children's Clinic

location_facility: University General Hospital of Heraklion

location_facility: Universitaetsklinikum Jena; Apotheke des Uniersitätsklinikums Jena

location_facility: Clinical Hospital Sveti Duh; Department of Neurology

location_facility: Bnai Zion Medical Center; Internal Medicine

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

location_facility: Ålborg Universitets Hospital; Gastromedicinsk

location_facility: Klaipeda Seamen's Hospital, Public Institution

location_facility: University of California at San Francisco

location_facility: IRCCS Ospedale Casa Sollievo della Soffenza; Stru Comp di Gastroenterologia ed Endoscopia digest

location_facility: Irkutsk State Medical Academy of Continuing Education

location_facility: Private Small Enterprise Medical Center Pulse

location_facility: Massachusetts General Hospital; Crohn's & Colitis Center

location_facility: Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont

location_facility: Medizinisches Zentrum Klinikum Lueneburg

location_facility: Chaim Sheba Medical Center; Pediatrics B North and Pediatric Endocrinology Unit

location_facility: McGuire Research Institute; Gastroenterology

location_facility: A.Novak Transcarpathian Regional Clinical Hospital

location_facility: Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology

location_facility: Haydarpasa Numune Training and Research Hospital; Medical Oncology

location_facility: CECIP - Centro de Estudos Clínicos do Interior Paulista

location_facility: University of California San Diego Medical Center

location_facility: Launceston General Hospital; Gastroenterology Research

location_facility: Great Lakes Gastroenterology Research, LLC

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska

location_facility: Kyungpook National University Medical Center

location_facility: FSBI "Scientific Research Institute of Physyology and Basic Medicine" under the SB of RAMS

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Azienda Ospedaliera Fatebenefratelli e Oftalmico

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: University of Mississippi Medical Center

location_facility: Ospedale di Circolo; Neuropsichiatria Infantile

location_facility: Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)

location_facility: CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv

location_facility: Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni

location_facility: Centro Regiomontano de Estudios Clínicos Roma S.C.

location_facility: Allmedica Badania Kliniczne Sp z o.o. Sp K.

location_facility: Medical and Sanitary Division of Severstal

location_facility: CAEP - Centro Avancado de Estudos e Pesquisas Ltda.

location_facility: Rabin Medical Center-Beilinson Campus; Gaucher Clinic, Genetics Institute

location_facility: SPb SBIH "City Multy-field Hospital # 2"; Intensive Pulmonology and Thoracal Surgery

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: Hospital Universitario Clementino Fraga Filho - UFRJ

summary: This two-part, part 1: open-label extension (OLE) and part 2: safety monitoring (SM) study will examine the efficacy and safety of continued etrolizumab treatment in moderate to severe ulcerative colitis (UC) participants previously enrolled in etrolizumab Phase II/III studies. Participants with moderate to severe UC who were enrolled in the Phase II OLE study (GA27927 [NCT01461317]) or the Phase III studies (GA28948 [NCT02163759], GA28949 [NCT02171429], GA28950 [NCT02100696], GA29102 [NCT02165215], and GA29103 [NCT02136069]) were included. Participants from the Phase II OLE study or the Phase III studies who are not eligible or willing to receive etrolizumab in the OLE-SM study, and who have completed the 12-week safety follow-up period will be enrolled in Part 2. Part 1 of OLE-SM will continue for up to 9 years after the first participant is enrolled into the study. Following Part 1, participants will enter Part 2 for a period of 92 weeks.


type: Other Identifier

title: Etude du Dosage Des d-dimères sériques Pour le Diagnostic d'Exclusion Des Thrombi Intra-atriaux Avant Ablation Endocavitaire de Fibrillation Atriale

summary: The purpose of this study is to determine whether D-dimer dosage allow to exclude risk of intraatrial thrombus before performing an ablation of atrial fibrillation

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Actual

lead_sponsor: Groupe Hospitalier de la Rochelle Ré Aunis

location_facility: Service de cardiologie, HP Les Franciscaines

location_facility: Service de cardiologie, Polyclinique Vauban

location_facility: Service de cardiologie, CHU Clermont Ferrand

location_facility: Service de cardiologie, CHI Aix Pertuis CHPA-CHIAP

location_facility: Service de cardiologie, CH de la Région d'Annecy

location_facility: Service de cardiologie, CHU Saint Etienne

location_facility: Service de cardiologie, Clinique Saint Joseph

location_facility: Service de cardiologie, CHR Metz Thionville

location_facility: Service de cardiologie, CHU Toulouse Hôtel Dieu St Jacques

location_facility: Service de cardiologie, Clinique Saint Gatien

location_facility: Service de cardiologie, HCL Groupement Est

location_facility: Service de cardiologie, Institut Mutualiste Montsouris

location_facility: Service de cardiologie, CHI Le Raincy Montfermeil

location_facility: Service de cardiologie, Hôpital Saint Joseph

location_facility: Service de cardiologie, AP Hôpital Henri Mondor

location_facility: Service de cardiologie, Nouvelles Cliniques Nantaises

location_facility: Service de cardiologie, AP Hôpital la Pitié Salpêtrière

location_facility: Service de cardiologie, Centre Cardiologique du Nord

location_facility: Service de cardiologie, APM Hôpital de La Timone

location_facility: Service de cardiologie, Groupe Hospitalier Bichat Claude Bernard

location_facility: Service de cardiologie, Institut Jacques Cartier

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


type: Other Grant/Funding Number

title: Analgesia of Acute Coronary Syndromes With ST-segment Elevation in a Pre-hospital Setting. Randomized Non-inferiority Trial of the Association MEOPA + Paracetamol Versus Morphine.

acronym: SCADOLII

summary: In the management of acute coronary syndromes with ST-segment elevation (STEMI), early analgesia reduces the effects of hyperadrenalism which increases the size of myocardial infarction. In order to reduce pain intensity, the recommendations advocate emergency use of morphine. In STEMI patients, other analgesic treatments could provide analgesia that is at least as effective as morphine. The equimolar oxygen/nitrous oxide mixture (MEOPA) is widely used in emergency medicine and has minor secondary effects that are very rapidly reversible when inhalation is discontinued. Used in association with paracetamol, it could be an at least equally effective alternative to the use of morphine.

study_start_date_type: Actual

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: background

ReferenceCitation: Danchin N, Puymirat E, Aissaoui N, Adavane S, Durand E. [Epidemiology of acute coronary syndromes in France and in Europe]. Ann Cardiol Angeiol (Paris). 2010 Dec;59 Suppl 2:S37-41. doi: 10.1016/S0003-3928(10)70008-1. French.

ReferenceCitation: Myocardial infarction redefined--a consensus document of The Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. Eur Heart J. 2000 Sep;21(18):1502-13. Review.

ReferenceCitation: Task Force for Diagnosis and Treatment of Non-ST-Segment Elevation Acute Coronary Syndromes of European Society of Cardiology, Bassand JP, Hamm CW, Ardissino D, Boersma E, Budaj A, Fernández-Avilés F, Fox KA, Hasdai D, Ohman EM, Wallentin L, Wijns W. Guidelines for the diagnosis and treatment of non-ST-segment elevation acute coronary syndromes. Eur Heart J. 2007 Jul;28(13):1598-660. Epub 2007 Jun 14.

ReferenceCitation: Van de Werf F, Bax J, Betriu A, Blomstrom-Lundqvist C, Crea F, Falk V, Filippatos G, Fox K, Huber K, Kastrati A, Rosengren A, Steg PG, Tubaro M, Verheugt F, Weidinger F, Weis M; ESC Committee for Practice Guidelines (CPG). Management of acute myocardial infarction in patients presenting with persistent ST-segment elevation: the Task Force on the Management of ST-Segment Elevation Acute Myocardial Infarction of the European Society of Cardiology. Eur Heart J. 2008 Dec;29(23):2909-45. doi: 10.1093/eurheartj/ehn416. Epub 2008 Nov 12.

ReferenceCitation: Canadian Cardiovascular Society; American Academy of Family Physicians; American College of Cardiology; American Heart Association, Antman EM, Hand M, Armstrong PW, Bates ER, Green LA, Halasyamani LK, Hochman JS, Krumholz HM, Lamas GA, Mullany CJ, Pearle DL, Sloan MA, Smith SC Jr, Anbe DT, Kushner FG, Ornato JP, Pearle DL, Sloan MA, Jacobs AK, Adams CD, Anderson JL, Buller CE, Creager MA, Ettinger SM, Halperin JL, Hunt SA, Lytle BW, Nishimura R, Page RL, Riegel B, Tarkington LG, Yancy CW. 2007 focused update of the ACC/AHA 2004 guidelines for the management of patients with ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2008 Jan 15;51(2):210-47. doi: 10.1016/j.jacc.2007.10.001. Review. Erratum in: J Am Coll Cardiol. 2008 Mar 4;51(9):977.

ReferenceType: derived

ReferenceCitation: Charpentier S, Galinski M, Bounes V, Ricard-Hibon A, El-Khoury C, Elbaz M, Ageron FX, Manzo-Silberman S, Soulat L, Lapostolle F, Gérard A, Bregeaud D, Bongard V, Bonnefoy-Cudraz E; SCADOL II investigators. Nitrous oxide/oxygen plus acetaminophen versus morphine in ST elevation myocardial infarction: open-label, cluster-randomized, non-inferiority study. Scand J Trauma Resusc Emerg Med. 2020 May 12;28(1):36. doi: 10.1186/s13049-020-00731-y.

lead_sponsor: University Hospital, Toulouse

location_country: France Réunion

location_facility: Centre Hospitalier Poulon la Seyne-sur-mer

location_facility: Centre Hospitalier Départemental La Roche/Yon

location_facility: Groupe hospitamier Lariboisière-Fernand Widal-St-Louis

intervention_type: Drug


title: A Phase II Trial of SGI-110 in Patients With IPSS High and Int 2 Myelodysplastic Syndrome, Acute Myeloid Leukemia With 20-30% Marrow Blasts or Chronic Myelomonocytic Leukemia Type 2 Not Responding to Azacitidine or Decitabine After at Least 6 Courses or Relapsing After a Response

summary: Treatment of patients with WHO defined IPSS int 2 and high risk MDS , AML with 20-30% marrow blasts and CMML type 2, after failure of azacitidine or decitabine exposure for at least 6 courses, or relapse after initial response.

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility: Centre Hospitalier de la région d'Annecy

location_facility: Hopital Purpan Service d'Hématologie Clinique

lead_sponsor_type: industriel


title: Multicenter, Randomized Study, Evaluation of Adapted Physical Activity Program in Patients With Unresectable, Locally Advanced or Metastatic Pancreatic Cancer

summary:
Adapted Physical Activity (APA) program may provide an opportunity to improve symptoms for patients with unresectable pancreatic cancer.

Thereby, it is proposed to conduct an open trial to assess effects of the APA program in such population

status: Unknown status

study_completion_date_type: Anticipated

primary_purpose: Basic Science

enrollment_type: Anticipated

ReferenceCitation: Neuzillet C, Vergnault M, Bonnetain F, Hammel P. Rationale and design of the Adapted Physical Activity in advanced Pancreatic Cancer patients (APACaP) GERCOR (Groupe Coopérateur Multidisciplinaire en Oncologie) trial: study protocol for a randomized controlled trial. Trials. 2015 Oct 12;16:454. doi: 10.1186/s13063-015-0983-8.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
CHU Robert Debré
Centre Georges François Leclerc
CH Saint Joseph Saint Luc
Institut de cancérologie de Lorraine
CHU Morvan
Hôpital Saint Antoine
Hôpital Européen
Hôpital Cochin
Centre Léon Bérard
Hôpital Beaujon
Polyclinique Bordeaux Nord Aquitaine
CHD Vendée
Institut Hospitalier Franco-Britannique
Hôpital FOCH
Centre Hospitalier de Belfort
Hôpital Henri Mondor
CH Mont de Marsan

status_simplified: Unknown


title: Evaluation of ONYX in ENDOVASCULAR Treatment of Cerebral AVMs. Prospective, Multi-center and Observational French Study

acronym: cAVM

summary: To assess safety and efficacy of ONYX treatment for cAVM:

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

ipd_sharing_description: No individual participant data will be available

lead_sponsor: Medtronic Neurovascular Clinical Affairs

location_facility:
CHU Besançon
CHU Nantes
Hôpital Bicêtre
CHU Strasbourg
HIA Sainte Anne
CHRU Tours
CHU Pontchaillou
CHU Toulouse
Hôpital Beaujon
Chu Pellegrin
CHU Côte de Nacre
Hôpital GUI DE CHAULLAC
CHI Dijon
Fondation Ophtamoligique Rothschild
Groupe Hospitalier Pitier Salpetrière
CHU Gabriel Montpied
CHP Clairval


title: Longitudinal Study of Brain Amyloid imaGing in MEMENTO

acronym: MEMENTOAmyGing

summary: A Multicenter national longitudinal cohort study including at least 800 individuals consecutively recruited from French Research Memory Centers and followed-up over 24 month and included in Memento.

design_allocation: Non-Randomized

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Saint-Etienne - Hôpital de la charité

location_facility: CHU de Bordeaux - Hôpital Xavier-Arnozan


title: Non Interventional Study Dealing With the Use of Trabectedin (Yondelis®)-Pegylated Liposomal Doxorubicin (Caelyx®) in Patient With Platinum-sensitive Relapse

summary: The French cooperative group GINECO proposes to implement an observational study to describe a real situation, in daily practice tolerance and methods of administration of trabectedin (Yondelis®)-Pegylated liposomal doxorubicin(Caelyx)®, in ovarian platinum sensitive cancer relapse.

ReferenceType: result

ReferenceCitation: Selle F, Heudel PE, Hardy-Bessard AC, Pozet A, Meunier J, Gladieff L, Lotz JP, Provansal M, Augereau P, Berton D, Bonichon-Lamichhane N, Orfeuvre H, Pautier P, Kalbacher E, Tazi Y, Spaeth D. GINECO Prospective Non-interventional PROSPECTYON Study: Trabectedin Plus Pegylated Liposomal Doxorubicin for Platinum-sensitive Recurrent Ovarian Cancer. Anticancer Res. 2020 Jul;40(7):3939-3945. doi: 10.21873/anticanres.14385.

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility: Hôpital de la Milétrie - Centre Hospitalier Universitaire de Poitiers - Pôle Régional de Cancérologie

location_facility: Hôpital Privé Drôme Ardèche - Clinique Pasteur

location_facility: Cabinet d'Oncologie - Hôpital Privé Sainte Marie

location_facility: Centre de Radiothérapie - Clinique Sainte-Anne

location_facility: Hôpital Morvan - Centre Hospitalier Universitaire

location_facility: Centre Hospitalier Universitaire Dupuytren


title: Multicentric, Randomized, Phase III Trial Comparing 2 Strategies in Patients With Non-squamous Non-small Cell Lung Cancer With Asymptomatic Brain Metastases

summary:
The patients carrying a complicated primary lung cancer brain metastases die in less than 3 months of delay disease in the absence of treatment. The median survival of these patients is approximately six months when the treatment associated with radiotherapy chemotherapy based on cisplatin is now the standard treatment. In most studies the patients die of their brain disease in one case only two, so it is likely that some patients do not require brain irradiation (prognosis in this case is linked to extra-cerebral disease ). The benefits for patients in group B (without systematic irradiation) are not to suffer the side effects of this radiation. The risks are in the same group to see brain metastases become symptomatic.

The role of cerebral radiotherapy in the patients treated with chemotherapy is unclear: should all patients be irradiated systematically (since the "reference" treatment is involved and with the aim of obtaining better control of the brain lesions and maintaining a better neurological status) or should only the patients showing cerebral progression be irradiated (avoidance of possibly useless brain radiotherapy and its side effects). The aim of this study is to better determine the position of cerebral radiotherapy in this context.

Main objective:

determine whether there is a difference in terms of progression-free survival between a therapeutic strategy with initial systematic brain radiotherapy followed by chemotherapy cis-platine/alimta + / - Bevacizumab and strategy with an initial chemotherapy cis-platine/alimta + / - Bevacizumab associated with brain radiotherapy only in cases of cerebral progression in patients with NSCLC with asymptomatic brain metastases

status: Terminated

primary_purpose: Other

ReferenceCitation: Monnet I, Vergnenègre A, Robinet G, Berard H, Lamy R, Falchero L, Vieillot S, Schott R, Ricordel C, Chouabe S, Thomas P, Gervais R, Madroszyk A, Abdiche S, Chiappa AM, Greillier L, Decroisette C, Auliac JB, Chouaïd C; GFPC 02-13 (METAL2) investigators. Phase III randomized study of carboplatin pemetrexed with or without bevacizumab with initial versus "at progression" cerebral radiotherapy in advanced non squamous non-small cell lung cancer with asymptomatic brain metastasis. Ther Adv Med Oncol. 2021 Apr 16;13:17588359211006983. doi: 10.1177/17588359211006983. eCollection 2021.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre Hospitalier Intercommunal de Cornouaille

location_facility: Hopital d'Instruction des Armées Sainte Anne

location_facility: Centre d'Oncologie et de Radiothérapie du Pays Basque

location_facility: Institut de Cancérologie de la Loire (I.C.L)

location_facility: Centre Hospitalier de la Région d'Annecy (CHRA)

intervention_type: Radiation


title: Pharmaco-epidemiological Study on the Effect of Retacrit® on Chemotherapy Induced Anaemia in Standard Oncology and Haematology Practice: Impact of Concomitant Iron Supplementation

acronym: SYNERGY

summary: The aim of this study is to describe, in a real-life context, the impact of an epoetin alpha biosimilar, Retacrit®, on anaemia in patients receiving chemotherapy, according to concomitant iron supplementation.

lead_sponsor: Hospira, now a wholly owned subsidiary of Pfizer

location_facility:
CHU Purpan
Clinique St Faron
Inst. Claudius Regaud
H.I.A Saint Anne
HARTMANN
Centre Oscar Lambret
Clinique des Bonnettes
Chu Gabriel Montpied
Clinique CONVERT
CHRA
Chu Timone
Chu Rennes
Hpt Rene Dubos
Chu Grenoble
Clinique des Dentellieres
CH Jacques Monod
Saint Antoine
Chu Estaing
Ch Duffaut
CHU du BOCAGE
Saint Louis
CH Boulogne-sur-Mer
Clinique St Laurent
Clinique de l'Ormeau
Chu Hopital Civil
Clinique Ste Marie
Hopital Foch
MEDIPOLE
Clinique Pasteur
Chp St Greg
Cac Jean Godinot
Chi Frejus - St Raphael
Hopital Des Courses
Victor Hugo
Hopital Louis Pasteur
CH Emile Muller
CHG St Gaudens
CAC Paul Strauss
TENON
Hopital Troyes
Hopital A.Pare
Chu St Eloi
CHR
CH Sainte Musse
CHG
Ico Angers
Clinique Vitalia Desertines
CHU SUD
CHG William MOREY
Victor Dubos
BEAUJON
Ch St Malo
Hopital Franco Britannique
IPC
Hopital Mignot
Clinique Rambot
Icl St Etienne
Ch Chambery
Ch Valence
Pole Sante Republique
Ch Le Mans
Hopital St Quentin
CHG Cahors
CHU Caremeau
Clinique Belvédère
Fondation Saint Joseph
Ch Du Pays D'Aix


title: Clinical Evaluation of Integrative Practices Units Infant and Child Care for Unit Children With Typical or Atypical Autism (AUTISM)

acronym: AUTISM

summary: The research project is part of the evaluation of the therapeutic approaches in mental health. Its framework infant and juvenile units that have developed "integrative devices," taking into account recent advances in knowledge and providing care, education and pedagogical approach. The evolution of autistic children receiving these integrative devices is studied to determine the validity of the devices mentioned. The methodology is based on case studies in a natural situation. Clinicians are committed to network among themselves and with researchers in a multicenter study.

ReferenceCitation: Bettencourt C, Garret-Gloanec N, Pellerin H, Péré M, Squillante M, Roos-Weil F, Ferrand L, Pernel AS, Apter G, Cohen D. Migration is associated with baseline severity and progress over time in autism spectrum disorder: Evidence from a French prospective longitudinal study. PLoS One. 2022 Oct 6;17(10):e0272693. doi: 10.1371/journal.pone.0272693. eCollection 2022.

lead_sponsor: Nantes University Hospital

location_facility: Unité de soins précoces HJ René Diatkine ASM13

intervention_type: Behavioral


acronym: HICKORY

title: Phase III, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Etrolizumab During Induction and Maintenance in Patients With Moderate to Severe Active Ulcerative Colitis Who Have Been Previously Exposed to TNF Inhibitors

lead_sponsor: Hoffmann-La Roche

type: EudraCT Number

source: euctr

ReferenceCitation: Peyrin-Biroulet L, Hart A, Bossuyt P, Long M, Allez M, Juillerat P, Armuzzi A, Loftus EV Jr, Ostad-Saffari E, Scalori A, Oh YS, Tole S, Chai A, Pulley J, Lacey S, Sandborn WJ; HICKORY Study Group. Etrolizumab as induction and maintenance therapy for ulcerative colitis in patients previously treated with tumour necrosis factor inhibitors (HICKORY): a phase 3, randomised, controlled trial. Lancet Gastroenterol Hepatol. 2022 Feb;7(2):128-140. doi: 10.1016/S2468-1253(21)00298-3. Epub 2021 Nov 17.

location_country:
Spain
Italy
United Kingdom
Lithuania
United States
Romania
Belgium
Czechia
Poland
Austria
Australia
Argentina
Israel
Mexico
Brazil
Canada
Switzerland
Hungary
Germany
Denmark
Greece
Korea, Republic of
France
Netherlands

location_facility: LKH - Universitätsklinikum der PMU Salzburg

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

location_facility: Queen Elizabeth II Health Sciences Centre; Gastroenterology Research

location_facility: Ålborg Universitets Hospital; Gastromedicinsk

location_facility: University of North Carolina at Chapel Hill

location_facility: Hadassah University Hospital - Ein Kerem; Neurosurgery

location_facility: University of California at San Francisco

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

location_facility: Fakultni nemocnice Brno; Interni kardiologicka klinika

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz; II. Belgyogyaszat

location_facility: Massachusetts General Hospital; Crohn's & Colitis Center

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely

location_facility: CHU Amiens - Hopital Sud; Pharmacie - Secteur des Essais cliniques

location_facility: Nottingham University Hospitals; QMC Campus

location_facility: Cliniques Universitaires Saint-Luc; Nephrology

location_facility: McGuire Research Institute; Gastroenterology

location_facility: Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology

location_facility: Cotton-O'Neil Clinical Research Center, Digestive Health

location_facility: Klinikum Klagenfurt am Wörtersee; Acute geriatric care

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Hamburgisches Forschungsinstitut fuer CED

location_facility: Rocky Mountain Gastroenterology Associates

location_facility: Gastroenterology Center of the Midsouth, P.C.

location_facility: Gastroenterology Associates of Central Georgia

location_facility: Fundacion Hospital de Alcorcon; Servicio de Digestivo

location_facility: Weill Cornell Medical College-New York Presbyterian Hospital

location_facility: University of California San Diego Medical Center

location_facility: University of Michigan; Michigan Institute for Clinical and Health Research (MICHR)

location_facility: Launceston General Hospital; Gastroenterology Research

location_facility: EuroMediCare Szpital Specjalistyczny z Przychodnią we Wrocławiu

location_facility: Great Lakes Gastroenterology Research, LLC

location_facility: Atlanta Gastroenterology Specialists, PC

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej SONOMED

location_facility: Digestive and Liver Disease Specialists, Ltd.

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda

location_facility: Klinikum Mannheim GmbH Universitätsklinikum

location_facility: Hospital Universitari de Girona Dr Josep Trueta

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

location_facility: Northwestern University Feinberg School Of Medicine

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

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Ospedale di Circolo; Neuropsichiatria Infantile

location_facility: Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner

location_facility: Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

location_facility: Seoul National University Bundang Hospital

location_facility: Hôpital Nord - CHU Marseille; Gastroenterology and Hepatology

location_facility: Vilnius University Hospital Santariskiu Clinic Public Insti

location_facility: Centro Regiomontano de Estudios Clínicos Roma S.C.

location_facility: Inselspital-Universitaetsspital Bern; Institut fuer Spitalpharmazie

location_facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN

location_facility: CAEP - Centro Avancado de Estudos e Pesquisas Ltda.

location_facility: Markhot Ferenc Oktato Korhaz es Rendelointezet

location_facility: Anticancer Hospital of Thessaliniki " Theagenio"

location_facility: Rabin Medical Center-Beilinson Campus; Gaucher Clinic, Genetics Institute

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo

location_facility: Rocky Mountain Gastroenterology Associates, P.L.L.C.; Gastroenterology

location_facility: Kyungpook National University Hospital; Opthalmology

location_facility: Rigshospitalet; Medicinsk gastroenterologisk klinik

location_facility: Hospital Universitario Clementino Fraga Filho - UFRJ

location_facility: Universitätsklinikum Freiburg; Innere Medizin I; Hämatologie, Onkologie und Stammzelltransplantation

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: Clinical Applications Laboratories, Inc.

location_facility: University of Calgary; Heritage Medical Research Clinic

summary: This Phase III, double-blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission compared with placebo in the treatment of participants with moderately to severely active ulcerative colitis (UC) who have been previously exposed to TNF inhibitors.


title: Pilot Study to Assess Efficacy and Safety of a Quadruple Therapy With Asunaprevir, Daclatasvir, Ribavirin and Pegylated Interferon Alpha-2a in HCV Genotype 4-infected Patients Non-responders to Pegylated Interferon-Ribavirin Regimen

summary:
Success rates, after retreatment with Peg-Interferon/Ribavirin bitherapy, in patients infected with HCV (hepatitis C virus) genotype 4 and non-responders to a first standard treatment, are disappointing. The association of Asunaprevir and Daclatasvir in combination with the standard-of-care bitherapy has been shown to increase the efficacy of the treatment in non-responders genotype 1-infected patients.

Given the absence of current solutions and urgent therapeutic needs for HCV genotype 4-infected patients previously treated with pegylated Interferon/Ribavirin, this pilot study aims to evaluate the efficacy and safety of a quadritherapy associating Asunaprevir, Daclatasvir, pegylated Interferon alpha-2a and Ribavirin, in this very difficult to treat population.

60 subjects will be enrolled.

The primary endpoint will be the rate of sustained virological response (SVR), defined by an undetectable HCV RNA, at Week 36 (12 weeks after the end of a 24 weeks quadritherapy).

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility:
Hôpital Henri Mondor
Hôpital AVICENNE
Hôpital Cochin
Hôpital Pontchaillou
Hôpital Paul Brousse
Hôpital Pitié Salpêtrière
Hôpital Charles Nicolle
Hôpital de Haut Lévêque
Hôpital Beaujon
Hôpital Albert Michallon
Hôpital Claude Huriez
Fondation Hôpital Saint Joseph
Hôpital Dupuytren
Hôpital Saint Antoine
Centre Hospitalier Intercommunal
Hôpital Tenon
Institut Arnault Tzank
Hôpital Purpan
Hôpital de Brabois
Hôpital de La Source
Hôpital de l'Archet
Hôpital Jean Verdier
Hôpital Saint Eloi
Hôpital de l'Hôtel Dieu
Hôpital de la Croix Rousse


title: Evaluation of the Non-inferiority of TulleGras M.S.® Versus Urgotul® in Pain Associated With Removal of Wound Dressing During Care of Venous Leg Ulcer. An Open-label, Multicenter, Randomized, Controlled, Crossover Study With Blinded Reading of Healing Criteria.

summary: Evaluation of the non-inferiority of TulleGras M.S.® versus Urgotul® in pain associated with removal of wound dressing during care of venous leg ulcer

lead_sponsor: Mylan Inc.

location_facility:
Research facility ID ORG-001081
Research facility ID ORG-000835
Research Facility ID ORG-000859
Research facility ID ORG-001083
Research Facility ID ORG-000869
Research facility ID ORG-000981
Research Facility ID ORG-000850
Research facility ID ORG-000836
Research facility ORG-001362
Research facility ID ORG-000853
Research Facility ID ORG-000862
Research facility ID ORG-000845
Research facility ID ORG-001215
Research facility ID ORG-001216
Research facility ID ORG-000831
Research Facility ID ORG-001183
Research facility ID ORG-000855
Research Facility ID ORG-000857
Research Facility ID ORG-001182
Research facility ID ORG-000856
Research Facility ID ORG-000844
Research Facility ID ORG-001181
Research facility ID ORG-000865
Research Facility ID ORG-000832
Research Facility ID ORG-000830
Research facility ORG-001361
Research facility ID ORG-001082

intervention_type: Device


title: RONNIE - A Multi-Center, Multi-National, Retrospective Medical Record Review to Describe Treatment Patterns and Outcomes for Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

summary: This multi-center, observational study involves reviewing the medical records of approximately 100 adult participants diagnosed with advanced BCC from 01 January 2005 until 31 December 2010. Participant records will be analyzed to identify participant characteristics, treatment patterns and clinical outcomes.

time_perspective: Retrospective

location_country:
Germany
France
United Kingdom
Italy

location_facility: Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie

location_facility: Klinikum der LMU München; Klinik und Poliklinik für Dermatologie und Allergologie

location_facility: Klinikum Dorothea Ch.Erxleben; Klinik für Dermatologie und Allergologie

location_facility: Hôpital Albert Michallon; Derm Phlebologie Allergologie

location_facility: Arcispedale Santa Maria Nuova; Dermatologia

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR, Hautklinik und Poliklinik

location_facility: HELIOS Klinikum Erfurt, Klinik für Hautkrankheiten und Allergologie

location_facility: Azienda Sanitaria di Firenze Presidio Palagi - SC Dermatologia II e Fisioterapia Dermatologica

location_facility: SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie

location_facility: A.O. Univ. Senese Policlinico S. Maria alle Scotte; Dip. Medicina clinica e Scienze Immunologiche

location_facility: Hopital Saint Vincent; Consult Dermatologie Enfants

location_facility: Chi Emile Durkheim Site Epinal; Oncologie

location_facility: Klinikum Mannheim Klinik fuer Dermatologie, Venerologie und Allergologie

location_facility: Hopital Timone Adultes; Radiotherapie Oncologie

location_facility: Western Infirmary; Division of Cardiovascular and Medical Sciences

location_facility: Universitätsmedizin Greifswald; Klinik für Mund-Kiefer-Gesichtschirurgie/Plastische Operationen

location_facility: Centre Hospitalier Lyon Sud; Dermatologie

location_facility: Hopital de Haut-Leveque; Dermatologie Serv.

location_facility: Manchester Royal Infirmary; Department Of Medicine

location_facility: Hôpital St Jacques de Besançon; (Dermatology)

location_facility: Policlinico Le Molinette; Clinica Dermatologica

location_facility: Hopital Saint Andre CHU De Bordeaux; Dermatologie

location_facility: Hopital Bichat Claude Bernard; Sce Dermatologie

location_facility: Università del Piemonte Orientale; Dipartimento di Dermatologia

location_facility: Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie


title: Contention Alone Versus Anticoagulation for Symptomatic Calf Vein Thrombosis Diagnosed by Ultrasonography

acronym: CACTUS-PTS

summary: CACTUS-PTS is a randomized, placebo-controlled, double-blind study which aims primarily to determine the effectiveness of a 6 week course of therapeutic-dose LMWH (nadroparine) injections vs. placebo in patients with a first symptomatic isolated distal (calf) deep-vein thrombosis (IDDVT), as measured by rate of proximal DVT and symptomatic PE at 6 weeks. Additionally, the study aims to determine if the 6 week course of treatment with therapeutic-dose LMWH (nadroparine) injections, compared to placebo, decreases the frequency of post-thrombotic syndrome (PTS) at 1 year.

ReferenceCitation: Righini M, Robert-Ebadi H, Glauser F, Blondon M, Ouvry P, Diamand JM, Tissot A, Frappe P, Quere I, Kahn SR, Galanaud JP, Le Gal G. Effect of anticoagulant treatment on pain in distal deep vein thrombosis: an ancillary analysis from the cactus trial. J Thromb Haemost. 2019 Mar;17(3):507-510. doi: 10.1111/jth.14387. Epub 2019 Feb 3.

ReferenceCitation: Righini M, Galanaud JP, Guenneguez H, Brisot D, Diard A, Faisse P, Barrellier MT, Hamel-Desnos C, Jurus C, Pichot O, Martin M, Mazzolai L, Choquenet C, Accassat S, Robert-Ebadi H, Carrier M, Le Gal G, Mermilllod B, Laroche JP, Bounameaux H, Perrier A, Kahn SR, Quere I. Anticoagulant therapy for symptomatic calf deep vein thrombosis (CACTUS): a randomised, double-blind, placebo-controlled trial. Lancet Haematol. 2016 Dec;3(12):e556-e562. doi: 10.1016/S2352-3026(16)30131-4. Epub 2016 Nov 8.

ReferenceCitation: Guanella R, Righini M. Serial limited versus single complete compression ultrasonography for the diagnosis of lower extremity deep vein thrombosis. Semin Respir Crit Care Med. 2012 Apr;33(2):144-50. doi: 10.1055/s-0032-1311793. Epub 2012 May 30. Review.

lead_sponsor: University Hospital, Geneva

location_country: Canada Switzerland France

location_facility:
Montpellier University Hospital
Hopital Maisonneuve-Rosemont
Hamilton General Hospital
Jewish General Hospital
Ottawa General Hospital
University Hospital of Geneva
Royal University Hospital


acronym: MYELAXAT

title: Evaluation of the Use of an Oral Direct Anti-Xa Anticoagulant, Apixaban, in Prevention of Venous Thromboembolic Disease in Patients Treated With IMiDs During Myeloma : a Pilot Study

lead_sponsor: University Hospital, Grenoble

ReferenceCitation: Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Porcari A, Raskob GE, Weitz JI; AMPLIFY-EXT Investigators. Apixaban for extended treatment of venous thromboembolism. N Engl J Med. 2013 Feb 21;368(8):699-708. doi: 10.1056/NEJMoa1207541. Epub 2012 Dec 8.

ReferenceCitation: Anagnostopoulos A, Weber D, Rankin K, Delasalle K, Alexanian R. Thalidomide and dexamethasone for resistant multiple myeloma. Br J Haematol. 2003 Jun;121(5):768-71.

ReferenceCitation: Attal M, Lauwers-Cances V, Marit G, Caillot D, Moreau P, Facon T, Stoppa AM, Hulin C, Benboubker L, Garderet L, Decaux O, Leyvraz S, Vekemans MC, Voillat L, Michallet M, Pegourie B, Dumontet C, Roussel M, Leleu X, Mathiot C, Payen C, Avet-Loiseau H, Harousseau JL; IFM Investigators. Lenalidomide maintenance after stem-cell transplantation for multiple myeloma. N Engl J Med. 2012 May 10;366(19):1782-91. doi: 10.1056/NEJMoa1114138.

ReferenceCitation: Barlogie B, Desikan R, Eddlemon P, Spencer T, Zeldis J, Munshi N, Badros A, Zangari M, Anaissie E, Epstein J, Shaughnessy J, Ayers D, Spoon D, Tricot G. Extended survival in advanced and refractory multiple myeloma after single-agent thalidomide: identification of prognostic factors in a phase 2 study of 169 patients. Blood. 2001 Jul 15;98(2):492-4.

ReferenceCitation: Baz R, Li L, Kottke-Marchant K, Srkalovic G, McGowan B, Yiannaki E, Karam MA, Faiman B, Jawde RA, Andresen S, Zeldis J, Hussein MA. The role of aspirin in the prevention of thrombotic complications of thalidomide and anthracycline-based chemotherapy for multiple myeloma. Mayo Clin Proc. 2005 Dec;80(12):1568-74.

ReferenceCitation: Blom JW, Doggen CJ, Osanto S, Rosendaal FR. Malignancies, prothrombotic mutations, and the risk of venous thrombosis. JAMA. 2005 Feb 9;293(6):715-22.

ReferenceCitation: Carrier M, Le Gal G, Tay J, Wu C, Lee AY. Rates of venous thromboembolism in multiple myeloma patients undergoing immunomodulatory therapy with thalidomide or lenalidomide: a systematic review and meta-analysis. J Thromb Haemost. 2011 Apr;9(4):653-63. doi: 10.1111/j.1538-7836.2011.04215.x. Review.

ReferenceCitation: Cavo M, Zamagni E, Tosi P, Cellini C, Cangini D, Tacchetti P, Testoni N, Tonelli M, de Vivo A, Palareti G, Tura S, Baccarani M. First-line therapy with thalidomide and dexamethasone in preparation for autologous stem cell transplantation for multiple myeloma. Haematologica. 2004 Jul;89(7):826-31.

ReferenceCitation: Chen C, Reece DE, Siegel D, Niesvizky R, Boccia RV, Stadtmauer EA, Abonour R, Richardson P, Matous J, Kumar S, Bahlis NJ, Alsina M, Vescio R, Coutre SE, Pietronigro D, Knight RD, Zeldis JB, Rajkumar V. Expanded safety experience with lenalidomide plus dexamethasone in relapsed or refractory multiple myeloma. Br J Haematol. 2009 Jul;146(2):164-70. doi: 10.1111/j.1365-2141.2009.07728.x. Epub 2009 May 26.

ReferenceCitation: Cohen AT, Davidson BL, Gallus AS, Lassen MR, Prins MH, Tomkowski W, Turpie AG, Egberts JF, Lensing AW; ARTEMIS Investigators. Efficacy and safety of fondaparinux for the prevention of venous thromboembolism in older acute medical patients: randomised placebo controlled trial. BMJ. 2006 Feb 11;332(7537):325-9. Epub 2006 Jan 26.

ReferenceCitation: Cohen AT, Spiro TE, Büller HR, Haskell L, Hu D, Hull R, Mebazaa A, Merli G, Schellong S, Spyropoulos AC, Tapson V; MAGELLAN Investigators. Rivaroxaban for thromboprophylaxis in acutely ill medical patients. N Engl J Med. 2013 Feb 7;368(6):513-23. doi: 10.1056/NEJMoa1111096.

ReferenceCitation: Connolly SJ, Eikelboom J, Joyner C, Diener HC, Hart R, Golitsyn S, Flaker G, Avezum A, Hohnloser SH, Diaz R, Talajic M, Zhu J, Pais P, Budaj A, Parkhomenko A, Jansky P, Commerford P, Tan RS, Sim KH, Lewis BS, Van Mieghem W, Lip GY, Kim JH, Lanas-Zanetti F, Gonzalez-Hermosillo A, Dans AL, Munawar M, O'Donnell M, Lawrence J, Lewis G, Afzal R, Yusuf S; AVERROES Steering Committee and Investigators. Apixaban in patients with atrial fibrillation. N Engl J Med. 2011 Mar 3;364(9):806-17. doi: 10.1056/NEJMoa1007432. Epub 2011 Feb 10.

ReferenceCitation: Dimopoulos M, Spencer A, Attal M, Prince HM, Harousseau JL, Dmoszynska A, San Miguel J, Hellmann A, Facon T, Foà R, Corso A, Masliak Z, Olesnyckyj M, Yu Z, Patin J, Zeldis JB, Knight RD; Multiple Myeloma (010) Study Investigators. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med. 2007 Nov 22;357(21):2123-32. Erratum in: N Engl J Med. 2009 Jul 30;361(5):544.

ReferenceCitation: Facon T, Mary JY, Hulin C, Benboubker L, Attal M, Pegourie B, Renaud M, Harousseau JL, Guillerm G, Chaleteix C, Dib M, Voillat L, Maisonneuve H, Troncy J, Dorvaux V, Monconduit M, Martin C, Casassus P, Jaubert J, Jardel H, Doyen C, Kolb B, Anglaret B, Grosbois B, Yakoub-Agha I, Mathiot C, Avet-Loiseau H; Intergroupe Francophone du Myélome. Melphalan and prednisone plus thalidomide versus melphalan and prednisone alone or reduced-intensity autologous stem cell transplantation in elderly patients with multiple myeloma (IFM 99-06): a randomised trial. Lancet. 2007 Oct 6;370(9594):1209-18.

ReferenceCitation: Goldhaber SZ, Leizorovicz A, Kakkar AK, Haas SK, Merli G, Knabb RM, Weitz JI; ADOPT Trial Investigators. Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients. N Engl J Med. 2011 Dec 8;365(23):2167-77. doi: 10.1056/NEJMoa1110899. Epub 2011 Nov 13.

ReferenceCitation: Heit JA, Silverstein MD, Mohr DN, Petterson TM, O'Fallon WM, Melton LJ 3rd. Risk factors for deep vein thrombosis and pulmonary embolism: a population-based case-control study. Arch Intern Med. 2000 Mar 27;160(6):809-15.

ReferenceCitation: Hussein MA. Thromboembolism risk reduction in multiple myeloma patients treated with immunomodulatory drug combinations. Thromb Haemost. 2006 Jun;95(6):924-30. Review.

ReferenceCitation: Johnson DC, Corthals S, Ramos C, Hoering A, Cocks K, Dickens NJ, Haessler J, Goldschmidt H, Child JA, Bell SE, Jackson G, Baris D, Rajkumar SV, Davies FE, Durie BG, Crowley J, Sonneveld P, Van Ness B, Morgan GJ. Genetic associations with thalidomide mediated venous thrombotic events in myeloma identified using targeted genotyping. Blood. 2008 Dec 15;112(13):4924-34. doi: 10.1182/blood-2008-02-140434. Epub 2008 Sep 19.

ReferenceCitation: Kristinsson SY, Pfeiffer RM, Björkholm M, Goldin LR, Schulman S, Blimark C, Mellqvist UH, Wahlin A, Turesson I, Landgren O. Arterial and venous thrombosis in monoclonal gammopathy of undetermined significance and multiple myeloma: a population-based study. Blood. 2010 Jun 17;115(24):4991-8. doi: 10.1182/blood-2009-11-252072. Epub 2010 Mar 18. Erratum in: Blood. 2011 Apr 7;117(14):3938.

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ReferenceCitation: Zufferey P, Laporte S, Quenet S, Molliex S, Auboyer C, Decousus H, Mismetti P. Optimal low-molecular-weight heparin regimen in major orthopaedic surgery. A meta-analysis of randomised trials. Thromb Haemost. 2003 Oct;90(4):654-61.

location_facility:
Clinique Victor Hugo
Ch Lyon Sud
Ch La Cote Basque
Chu Grenoble
Centre Hospitalier
Chru Hopital Huriez
Chu Hopital Henri Mondor
Hopital St Vincent - Ghicl
Hopital de L'Archet
Chu Bordeaux
Chu Poitiers
Ch de Perigueux
Hopital Pitie Salpetriere
Chru de Tours
Centre Leon Berard
Groupe Hospitalier Du Havre
Chd Vendee
Hia Percy
CHRA

summary:
To evaluate:

the incidence of venous thromboembolic event (VTE)
the incidence of hemorrhagic complications, In a population of patients with myeloma who are treated with IMiDs and require thromboprophylaxis for 6 months, using an oral anti-Xa anticoagulant, Apixaban, in a preventive scheme, 2.5 mg x2/day


summary: This observational study will evaluate patients' perception of treatment with erythropoiesis-stimulating agents in patients with chronic kidney disease not on dialysis. Eligible patients initiated on treatment with Mircera (methoxy polyethylene glycol-epoetin beta) will be followed for 6 months.


title: Risk Factors for Thromboembolic and Infectious Complications Related to Percutaneous Central Venous Catheters in Cancer - Prospective Multicenter Study

acronym: ONCOCIP

summary: The purpose of this study is to identify risk factors for thromboembolic and /or infectious complications in 3,000 patients with solid tumor and receiving a Percutaneous Central Venous Catheter (PCVC). A better understanding of the risk factors for these complications in this population would then allow interventional studies to be proposed to assess the benefit of prophylactic procedures in a sub-group of patients at most risk.

ReferenceCitation: Agnelli G, George DJ, Kakkar AK, Fisher W, Lassen MR, Mismetti P, Mouret P, Chaudhari U, Lawson F, Turpie AG; SAVE-ONCO Investigators. Semuloparin for thromboprophylaxis in patients receiving chemotherapy for cancer. N Engl J Med. 2012 Feb 16;366(7):601-9. doi: 10.1056/NEJMoa1108898.

ReferenceCitation: Debourdeau P, Farge D, Beckers M, Baglin C, Bauersachs RM, Brenner B, Brilhante D, Falanga A, Gerotzafias GT, Haim N, Kakkar AK, Khorana AA, Lecumberri R, Mandala M, Marty M, Monreal M, Mousa SA, Noble S, Pabinger I, Prandoni P, Prins MH, Qari MH, Streiff MB, Syrigos K, Büller HR, Bounameaux H. International clinical practice guidelines for the treatment and prophylaxis of thrombosis associated with central venous catheters in patients with cancer. J Thromb Haemost. 2013 Jan;11(1):71-80. doi: 10.1111/jth.12071. Review.

ReferenceCitation: Saber W, Moua T, Williams EC, Verso M, Agnelli G, Couban S, Young A, De Cicco M, Biffi R, van Rooden CJ, Huisman MV, Fagnani D, Cimminiello C, Moia M, Magagnoli M, Povoski SP, Malak SF, Lee AY. Risk factors for catheter-related thrombosis (CRT) in cancer patients: a patient-level data (IPD) meta-analysis of clinical trials and prospective studies. J Thromb Haemost. 2011 Feb;9(2):312-9. doi: 10.1111/j.1538-7836.2010.04126.x.

ReferenceCitation: Akl EA, Kamath G, Yosuico V, Kim SY, Barba M, Sperati F, Cook DJ, Schünemann HJ. Thromboprophylaxis for patients with cancer and central venous catheters: a systematic review and a meta-analysis. Cancer. 2008 Jun;112(11):2483-92. doi: 10.1002/cncr.23479. Review.

ReferenceCitation: Mollee P, Jones M, Stackelroth J, van Kuilenburg R, Joubert W, Faoagali J, Looke D, Harper J, Clements A. Catheter-associated bloodstream infection incidence and risk factors in adults with cancer: a prospective cohort study. J Hosp Infect. 2011 May;78(1):26-30. doi: 10.1016/j.jhin.2011.01.018. Epub 2011 Apr 2.

ReferenceCitation: Chaukiyal P, Nautiyal A, Radhakrishnan S, Singh S, Navaneethan SD. Thromboprophylaxis in cancer patients with central venous catheters. A systematic review and meta-analysis. Thromb Haemost. 2008 Jan;99(1):38-43. doi: 10.1160/TH07-07-0446. Review.

ReferenceCitation: Khorana AA, Francis CW, Blumberg N, Culakova E, Refaai MA, Lyman GH. Blood transfusions, thrombosis, and mortality in hospitalized patients with cancer. Arch Intern Med. 2008 Nov 24;168(21):2377-81. doi: 10.1001/archinte.168.21.2377.

ReferenceCitation: Schwarz RE, Groeger JS, Coit DG. Subcutaneously implanted central venous access devices in cancer patients: a prospective analysis. Cancer. 1997 Apr 15;79(8):1635-40.

ReferenceCitation: Decousus H, Bourmaud A, Fournel P, Bertoletti L, Labruyère C, Presles E, Merah A, Laporte S, Stefani L, Piano FD, Jacquin JP, Meyer G, Chauvin F; ONCOCIP Investigators. Cancer-associated thrombosis in patients with implanted ports: a prospective multicenter French cohort study (ONCOCIP). Blood. 2018 Aug 16;132(7):707-716. doi: 10.1182/blood-2018-03-837153. Epub 2018 Jul 6.

lead_sponsor: Institut de Cancérologie de la Loire

location_facility: CHU Saint-Etienne Service de Gastroentérologie

location_facility: CHU Saint-Etienne Service de Gynécologie


title: A Phase I/II Randomized Study to Determine the Maximum Tolerated Dose, Safety, Pharmacokinetics and Antitumor Activity of Debio 1143 Combined With Concurrent Chemo-Radiation Therapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck.

summary:
The use of multiple drugs in a single clinical trial or as a therapeutic strategy has become common, particularly in the treatment of cancer. Because traditional trials are designed to evaluate one agent at a time, the evaluation of therapies in combination requires specialized trial designs. In place of the traditional separate phase I and II trials, this trial uses a single phase I/II clinical trial to evaluate simultaneously the safety and efficacy of combination dose levels, and select the optimal combination dose.

Therefore, this is a two part trial of Debio 1143 combined with concurrent cisplatin and radiotherapy (CRT) in participants with previously untreated stage III, IVa or IVb head and neck cancer. The trial begins with an initial period of dose escalation (Phase I) to investigate the maximum tolerated dose (MTD) of Debio 1143 that can safely be given in combination with CRT.

Using the MTD determined in the Phase I portion, the randomized phase II trial in 94 participants compares Debio 1143 to placebo, both with concomitant CRT. The aim is to evaluate the efficacy and safety of Debio 1143.

ReferenceCitation: Sun XS, Tao Y, Le Tourneau C, Pointreau Y, Sire C, Kaminsky MC, Coutte A, Alfonsi M, Boisselier P, Martin L, Miroir J, Ramee JF, Delord JP, Clatot F, Rolland F, Villa J, Magne N, Elicin O, Gherga E, Nguyen F, Lafond C, Bera G, Calugaru V, Geoffrois L, Chauffert B, Zubel A, Zanna C, Brienza S, Crompton P, Rouits E, Gollmer K, Szyldergemajn S, Bourhis J. Debio 1143 and high-dose cisplatin chemoradiotherapy in high-risk locoregionally advanced squamous cell carcinoma of the head and neck: a double-blind, multicentre, randomised, phase 2 study. Lancet Oncol. 2020 Sep;21(9):1173-1187. doi: 10.1016/S1470-2045(20)30327-2. Epub 2020 Aug 3.

lead_sponsor: Debiopharm International SA

location_country: France Switzerland

location_facility: Institut de Cancérologie de l'Ouest (ICO) René Gauducheau

location_facility: Institut de Cancérologie Lucien Neuwirth (ICLN)

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Inselspital Bern, Universitätsklinik für Radio-Onkologie, Freiburgstrasse 4

location_facility: Centre Hospitalier de Bretagne Sud - HÔPITAL DU SCORFF

location_facility: L'Institut de Cancérologie de Lorraine (ICL) Alexis Vautrin