title: PROPHYLACTIC TREATMENT FOR CHEMO-INDUCED NEUTROPENIA. USE OF G-CSF BIOSIMILAR (NIVESTIM(REGISTERED)) ACCORDING TO THE CHEMOTHERAPY CONTEXT: ADJUVANT VERSUS METASTATIC.

acronym: VISTA

summary: The aim of this study is to describe in real-life conditions the determinants of use of GCSF (Granulocyte Colony-Stimulating Factor) Nivestim® in primary or secondary prophylaxis and in patients receiving chemotherapy for solid tumour according to the chemotherapy context: adjuvant or metastatic setting.

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_facility: Centre Hospitalier de Cholet Service d' Oncologie Médicale

location_facility: CHU de Dijon - Hôpital du Bocage Service Hépato-Gastro-Entérologie

location_facility: CHI Fréjus Saint Raphaël Service d'Oncologie Médicale

location_facility: Hôpital de Saint-Avold Service Oncologie II

location_facility: Hôpital Rangueil Service d'Oncologie Médicale Digestive et Gynécologique

location_facility: CHU de Nantes - Hôpital Laënnec Service d'Oncologie Médicale

location_facility: Centre Hospitalier Service de Pneumologie

location_facility: Clinique Rambot La Provençale Tour d'Aygosi

location_facility: CHU - Hôpital Hôtel Dieu Unité de Gastroentérologie

location_facility: Hôpital Européen Georges Pompidou Service Oncologie Médicale - 4e étage (ascenseur B)

location_facility: Hôpital Avicenne Service Gastro-Entérologie

location_facility: Hôpital Louis Pasteur Service de Pneumologie - Médecine F

location_facility: Centre Léon Bérard Service d'Oncologie Médicale

location_facility: CHP du Cotentin - Site de Cherbourg Service d'Oncologie

location_facility: Centre Hospitalier Privé Clairval Service de Cancérologie

location_facility: Centre Hospitalier de Cholet Service d'Hepato-Gastro-Enterologie

location_facility: Clinique du Dr Maymard Service d'Oncologie

location_facility: CHU - Hôpital Jean Minjoz Service Oncologie Médicale

location_facility: CHU Dupuytren Limoges Service d'Oncologie

location_facility: Institut Mutualiste Montsouris Service Oncologie Médicale

location_facility: Polyclinique de Gentilly Service Oncologie Médicale

location_facility: CHI des Alpes du sud Site de Gap Muret Hôpital de Jour - Oncologie

location_facility: Hôpital de Thionville Service Oncologie Médicale

location_facility: Centre Hospitalier du Pays d'Aix Service d'Hématologie - Oncologie

location_facility: Clinique Clementville Service d'Oncologie

location_facility: Centre Hospitalier de Belfort-Montbéliard Site du Mittan-Oncologie et radiothérapie

location_facility: Institut Franco Britannique Service Oncologie Médicale

location_facility: Hôpital Tenon Service d'oncologie médicale

location_facility: Clinique Hartman Service de Radiothérapie

location_facility: Centre Hospitalier Service de Médecine 2 - Hôpital de jour

location_facility: Centre Hospitalier Privé Saint-Grégoire Service d'Oncologie - Radiothérapie

location_facility: CH de Cornouaille Service d'Oncologie Médicale

location_facility: Centre Hospitalier Service Onco-Hématologie

location_facility: ICO Centre Paul Papin Service d'Oncologie Médicale

location_facility: Centre Hospitalier de Carcassonne Service d'Oncologie

location_facility: Centre Marie Curie A l'attention de Laëtitia

location_facility: Hôpital Louis Pradel Service Pneumologie - Centre des Maladies Orphelines

location_facility: CH Saint-Joseph et Saint-Luc Service de Gastro-Entérologie

location_facility: Centre de Radiothérapie SCP Strasbourg Oncologie Libérale

location_facility: CHU Montpellier - Hôpital Arnaud de Villeneuve Service de Cancérologie

location_facility: Hôpital Européen Georges Pompidou Service d'Oncologie Médicale

location_facility: Hôpital Augustin Morvan Institut de Cancérologie et d'Hématologie

location_facility: CH William Morey Service d'Oncologie Médicale

location_facility: Hôpital Privé Jean Mermoz Service d'Oncologie Médicale

location_facility: Clinique Chirurgicale Pasteur Service Oncologie Médicale

location_facility: Clinique Alleray Labrouste Service d'Oncologie Médicale

location_facility: Clinique Claude Bernard Service Chimiothérapie

location_facility: Hôpital Bichat Claude Bernard Service Hépato-Gastroentérologie et Cancérologie Digestive

location_facility: Hôpital de Falconaja Furiani Service d'Oncologie

location_facility: Centre François Baclesse Oncologie Médicale. Pathologie Mammaire et Recherche Clinique

location_facility: CHRU Lille - Hôpital Huriez Unité d'Oncologie Médicale

location_facility: Hôpital Nord Service d'Oncologie Multidisciplinaires et Innovations Thérapeutiques

location_facility: Centre Hospitalier de la region d'Annecy Pole Medecine

location_facility: CHU - Hôtel-Dieu Service Hépato-Gastro-entérologie

location_facility: Hôpital Bretonneau Service d'Oncologie Médicale

location_facility: Centre Hospitalier Layne Service d'Oncologie

location_facility: Centre Clinical Service d'Oncologie-Radiothérapie

location_facility: CH de Mulhouse - Hôpital Emile Muller Hôpital de Jour - Oncologie

location_facility: Clinique Pasteur Lanroze Service Oncologie

location_facility: Centre Hospitalier Philippe le Bon Service de Medecine Interne - 3e Etage

location_facility: Centre Hospitalier Privé Saint Grégoire Service d'Oncologie - Radiothérapie

location_facility: Centre hospitalier Louis Pasteur Service de Pneumologie

location_facility: Hôpital Morvan - CHU Institut de Cancérologie et d'Hématologie

location_facility: Clinique Claude Bernard Service de Chimiothérapie

location_facility: Centre Hospitalier de Narbonne Oncologie / Hématologie

location_facility: Centre Hospitalier de la Dracénie Service d'Oncologie

location_facility: Centre Hospitalier Emile Durkheim Service Oncologie

location_facility: Centre Hospitalier Annecy Genevois Service Pneumologie


title: A 6-month, Open Label, Randomised, Efficacy Study to Evaluate Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) Inhalation Powder Delivered Once Daily Via the Dry Powder Inhaler ELLIPTA™ Compared With Usual ICS/LABA Maintenance Therapy Delivered by Dry Powder Inhaler in Subjects With Persistent Asthma

summary: The combination of FF, an ICS and VI, an orally inhaled LABA has been developed as a once-daily combination therapy for the long-term maintenance treatment of asthma in adults and children >=12 years of age. Pivotal phase III studies have demonstrated the safety and efficacy of FF/VI in asthma. However, it is increasingly acknowledged that randomised clinical trials tend to be highly controlled and enrol a more highly selected subject population than is expected to be prescribed the medication post-approval. There is a need for data in a more representative population in close to a 'real life' conditions, where physicians have the ability to choose the best treatment in their view for any individual subject and adapt treatments to subjects' characteristics and response. This multi-center, open-label, randomized, parallel group study will evaluate the efficacy and safety of FF/VI compared with two usual ICS/LABA fixed combination (fluticasone propionate/salmeterol [FP/S] or budesonide/formoterol [BUD/F]) in subjects with persistent asthma, in a "close to real life" settings. FF/VI will be administered once-daily (QD) via ELLIPTA dry powder inhaler (DPI) and FP/S or BUD/F will be administered twice daily (BID) via DISKUS™ and TURBUHALER™ DPI respectively. ELLIPTA is a new powder inhaler designed to be easy to use. The total duration of subject participation will be approximately 6 months (24 weeks). ELLIPTA and DISKUS are registered trademarks of the GSK group of companies. TURBUHALER is a registered trademark of AstraZeneca.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Devillier P, Humbert M, Boye A, Zachgo W, Jacques L, Nunn C, West S, Nicholls A, Antoun Z, Spinu L, Grouin JM. Efficacy and safety of once-daily fluticasone furoate/vilanterol (FF/VI) versus twice-daily inhaled corticosteroids/long-acting β(2)-agonists (ICS/LABA) in patients with uncontrolled asthma: An open-label, randomized, controlled trial. Respir Med. 2018 Aug;141:111-120. doi: 10.1016/j.rmed.2018.06.009. Epub 2018 Jun 9.

lead_sponsor: GlaxoSmithKline

location_country: Germany France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized Trial of Delayed Radiotherapy in Patients With Newly Diagnosed 1p/19q Codeleted Anaplastic Oligodendroglial Tumors: the POLCA Trial.

acronym: POLCA

summary: Patients with 1p/19q-codeleted anaplastic gliomas treated with RT + PCV are at risk of neurocognitive deterioration. Treating these patients with PCV alone (could reduce the risk of neurocognitive deterioration without impairing overall survival.

status: Active, not recruiting

study_completion_date_type: Anticipated

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris

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

location_facility: IUCT Oncopole - CLCC Institut Claudius Regaud

location_facility: GH Est-Institut d'hématologie et d'oncologie pédiatrique IHOP

location_facility: ICM, Institut régional du Cancer de Montpellier

location_facility: Centre Hospitalier de Bretagne Sud - Hôpital du Scorff

lead_sponsor_type: academique

status_simplified: Ongoing


title: A Post-authorization, Non-interventional, Safety Study Study of Patients With Myelodysplastic Syndromes (MDS) Treated With Lenalidomide.

acronym: PASS MDS del5q

summary:
This registry is a prospective, non-interventional, post authorisation safety study for patients diagnosed with Transfusion Dependent, IPSS low or intermediate-1-Risk Myelodysplastic Syndrome (MDS), associated to a single abnormality of the chromosome 5 [del(5q)].

The purpose of this study is to collect additional data about the safety of an oral drug (lenalidomide, Revlimid®) that may have been prescribed to relieve anemia and decrease the need of blood transfusions. However, also patients affected by the MDS del(5q) who receive other treatments different from lenalidomide can be included in this study, if they agree.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Celgene

location_country:
Denmark
Luxembourg
Spain
Greece
Italy
United Kingdom
Sweden
United States
France
Belgium
Norway
Germany

location_facility: Lund University Hospital - Lasarettsgatan 23

location_facility: Kreiskrankenhaus St. Elisabeth - Von Werth-Str.

location_facility: Hospital Universitario central de Asturias

location_facility: Praxis, Onkologische Schwerpunktpraxis Dres. Verpoort

location_facility: H.U.Marq.Valdecilla, Hospital Universitario Marqués de Valdecilla. Hematología

location_facility: Hopital de Hautepierre CHRU de Strasbourg

location_facility: Abteilung Hämatologie, Internistische Onkologie, Universitatklinikum Leipzig

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Hospital del Mar,Hematologia Hemotheropia

location_facility: Hospital Universitario de Gran Canaria Servicio de Hematología y

location_facility: Radcliffe Hospitals and University - Headley Way, Headington

location_facility: AOU Policlinico Tor Vergata, Università Roma Tor Vergata

location_facility: III. Medizinische Klinik, Hämatologie und internistische Onkologie , Univesitatsmedizin Mannheim

location_facility: AOU Ospedali Riuniti Umberto I G.M. Lancisi G. Salesi

location_facility: Azienda Ospedaliera Papa Giovanni XX111 Piazza OMS

location_facility: ZENTRUM FÜR INNERE MEDIZIN, Universitatklinikum Wurzburg

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Hämatologie und Onkologie, Klinikum Chemnitz gGmbH International Patient Center

location_facility: Azienda Ospedaliera Universitaria di Sassari

location_facility: Institut für Versorgungsforschung in der Onkologie

location_facility: Broomfield Hospital - Mid-Essex Hospitals NHS Trust

location_facility: Uniklinikum Düsseldorf, Klinik für Hämatologie, Onkologie und Klinische Immunologie

location_facility: Hospital Universitario fundacion Jiminez Diaz

location_facility: Department of Hematology, Hospital Duran i Reynals

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie

location_facility: Centre Hospitalier D'Avignon - Hopital Henri Duffaut

location_facility: Policlinico S.Orsola Malpighi, AOU di Bologna

location_facility: III. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München

location_facility: Centre Hospitalier Universitaire De Limoges - Hopital Dupuyt

location_facility: Aberdeen Royal Infirmary - Foresterhill Road

location_facility: CHRU De Lille - Hôpital Claude - Rue Michel Polonovski

location_facility: Gemeinschaftspraxis fur Hamatologie und Onkologie, Onkologisches zentrum Lebach

location_facility: Innere Medizin II - Onkologie, Hämatologie, Univesitatklinikum Tubingen

location_facility: CHU Nancy Brabois Adultes - 58 Allee dy morvan


title: A Multicomponent Intervention to Reduce Perceived Discomforts in Critically Ill Patients: a Randomized Controlled Trial

summary: Since critically ill patients are exposed to stressful conditions, the investigators evaluated the effectiveness of a multicomponent program to reduce perceived discomforts in the Intensive Care Unit (ICU) .

primary_purpose: Supportive Care

ReferenceType: background

ReferenceCitation: Kalfon P, Mimoz O, Auquier P, Loundou A, Gauzit R, Lepape A, Laurens J, Garrigues B, Pottecher T, Mallédant Y. Development and validation of a questionnaire for quantitative assessment of perceived discomforts in critically ill patients. Intensive Care Med. 2010 Oct;36(10):1751-1758. doi: 10.1007/s00134-010-1902-9. Epub 2010 May 26.

ReferenceCitation: Kalfon P, Boucekine M, Estagnasie P, Geantot MA, Berric A, Simon G, Floccard B, Signouret T, Fromentin M, Nyunga M, Audibert J, Ben Salah A, Mauchien B, Sossou A, Venot M, Robert R, Follin A, Renault A, Garrouste-Orgeas M, Collange O, Levrat Q, Villard I, Thevenin D, Pottecher J, Patrigeon RG, Revel N, Vigne C, Azoulay E, Mimoz O, Auquier P, Baumstarck K; IPREA Study Group. Risk factors and events in the adult intensive care unit associated with pain as self-reported at the end of the intensive care unit stay. Crit Care. 2020 Dec 7;24(1):685. doi: 10.1186/s13054-020-03396-2.

ReferenceCitation: Baumstarck K, Boucekine M, Estagnasie P, Geantot MA, Berric A, Simon G, Floccard B, Signouret T, Fromentin M, Nyunga M, Sossou A, Venot M, Robert R, Follin A, Audibert J, Renault A, Garrouste-Orgeas M, Collange O, Levrat Q, Villard I, Thevenin D, Pottecher J, Patrigeon RG, Revel N, Vigne C, Azoulay E, Mimoz O, Auquier P, Kalfon P; IPREA Study group. Assessment of patients' self-perceived intensive care unit discomforts: Validation of the 18-item version of the IPREA. Health Qual Life Outcomes. 2019 Feb 7;17(1):29. doi: 10.1186/s12955-019-1101-5.

ReferenceCitation: Kalfon P, Baumstarck K, Estagnasie P, Geantot MA, Berric A, Simon G, Floccard B, Signouret T, Boucekine M, Fromentin M, Nyunga M, Sossou A, Venot M, Robert R, Follin A, Audibert J, Renault A, Garrouste-Orgeas M, Collange O, Levrat Q, Villard I, Thevenin D, Pottecher J, Patrigeon RG, Revel N, Vigne C, Azoulay E, Mimoz O, Auquier P; IPREA Study group. A tailored multicomponent program to reduce discomfort in critically ill patients: a cluster-randomized controlled trial. Intensive Care Med. 2017 Dec;43(12):1829-1840. doi: 10.1007/s00134-017-4991-x. Epub 2017 Nov 27.

ReferenceCitation: Kalfon P, Mimoz O, Loundou A, Geantot MA, Revel N, Villard I, Amour J, Azoulay E, Garrouste-Orgeas M, Martin C, Sharshar T, Baumstarck K, Auquier P. Reduction of self-perceived discomforts in critically ill patients in French intensive care units: study protocol for a cluster-randomized controlled trial. Trials. 2016 Feb 16;17:87. doi: 10.1186/s13063-016-1211-x.

ipd_sharing: Yes

lead_sponsor: Dr Pierre KALFON

location_facility: CHU Hôpital Européen Georges Pompidou APHP

intervention_type: Other


title: Phase II/III Randomized Study to Improve Overall Survival in 18 to 60 Year-old Patients, Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens, High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens, and Standard Versus Mycophenolate Mofetil Prophylaxis of Graft Versus Host Disease in Allografted Patients in First CR : a Backbone InterGroup-1 Trial

summary: This open label, multicenter phase II/III study with multiple randomization phases at differents stages of AML treatment (induction, consolidation and HSCT where applicable) is designed to improve OS in younger (18 to 60 year-old) patients, with AML risk-adapted patient strategies. Within the intermediate risk AML group, optimal GvHD prophylaxis following allogeneic SCT in first CR, after either myeloablative (MAC) or reduced intensity (RIC) conditioning, will also be evaluated. With an adaptative design, this clinical trial could test up to 3 novel AML agents of interest.

status: Recruiting

enrollment_type: Anticipated

lead_sponsor: University Hospital, Angers

location_facility: Institut de Cancérologie Lucien Neuwirth


primary_purpose: Prevention

intervention_type: Biological

title: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), in Children With Hemodynamically Significant Congenital Heart Disease

lead_sponsor: MedImmune LLC

source: euctr

location_country:
Denmark
Poland
Spain
United Kingdom
Austria
Lebanon
Russian Federation
Canada
Czech Republic
Sweden
Hungary
United States
France
Israel
Belgium
Germany
Bulgaria

location_facility: Washington University School of Medicine

location_facility: Specialized Hospital for Active Treatment of Pediatric Diseases

location_facility: Nemours Children's Clinic Biomedical Research Department

location_facility: Gottsegen Gyorgy Orszagos Kardiologiai Intezet, Gyermeksziv Kozpont

location_facility: Children's and Women's Hospital of BC, Room #1R11

location_facility: University Hospitals of Leicester NHS Trust

location_facility: Schneider Children's Medical Center of Israel

location_facility: University Mulitiprofile Hospital for Active Treatment "St.Georgi"

location_facility: Research Cardiology Institute of Tomsk Scientific Center

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

location_facility: Veszprém Megyei Önkormányzat - Csolnoky Ferenc Kórház

location_facility: Universitätsklinik für Kinder- und Jugendheilkunde

location_facility: Meshalkin Research Institue of Blood circulation

location_facility: Samodzielny Publiczny Szpital Akademii Medycznej

location_facility: Instytut "Pomnik - Centrum Zdrowia Dziecka"

location_facility: American University of Beirut Medical Center

location_facility: Dzieciecy Szpital Kliniczny im. Prof. Antoniego Gebal Poliklinika

location_facility: Specialized Hospital for Active Treatment of Cardio-vascular Diseases

location_facility: Royal Belfast Hospital for Sick Children

location_facility: James Whitcomb Riley Hospital for Children

location_facility: Ziekenhuisnetwerk Antwerpen - Koningin Paola Kinderziekenhuis

location_facility: University Multifunctional Hospital for Active Treatment

location_facility: Children's Hospital and Research Center at Oakland

location_facility: Hospital Infantil Universitario Virgen del Rocío

location_facility: Ginekologiczno-Poloznicy Szpital Kliniczny Uniwersytetu Medycznego w Poznaniu

location_facility: Regional Dispensary for Pulmonary Diseases with Inpatient sector-Rousse

location_facility: Tulane University Health Sciences Center

location_facility: Saint Petersburg State Pediatric Medical Academy

location_facility: Hospital Universitario Virgen de Las Nieves

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 im. Tadeusza Sokolowskiego Pomorskiej AM w Szczecinie

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Wojewodzki Szpital im. dr Jana Biziela w Bydgoszczy

location_facility: Wojewodzki Szpital Dzieciecy W Bydgoszczy

location_facility: Szpital Kliniczny Uniwersytetu Medycznego im. Karola Jonschera

location_facility: St. Petersburg City Children's Hospital #1

location_facility: Multifunctional Hospital for Active Treatment - Pleven

location_facility: University of California Davis Medical Center

location_facility: Szegedi Tudomanyegyetem AOK, Gyermekgyogyaszati Klinika

location_facility: Suny At Stony Brook University Medical Center

location_facility: Hospital Universitario Virgen de la Arrixaca

summary: The primary goal was to describe the safety of the investigational product when given monthly to prevent serious respiratory infection among children with significant heart disease.


type: EudraCT Number

title: A Multicentre, Randomised, Double-blind, Controlled, Phase IIIb Study to Assess the Efficacy and Safety of Rivaroxaban 10mg od Versus Enoxaparin 4000 UI for VTE PROphylaxis in NOn Major Orthopaedic Surgery

acronym: PRONOMOS

summary:
PRONOMOS is an international multicentre, interventional, parallel, randomised, double-blind non-inferiority study comparing rivaroxaban 10mg od to an active comparator, enoxaparin 4000 UI od in 4040 valid subjects requiring orthopaedic surgery (except low risk such material removal foot surgery or hallux valgus without patient risk factor [6], and major orthopaedic surgeries for femoral neck and trochanteric fractures, THR, TKR)

Pre-randomization treatment with LMWH anticoagulant is allowed for a maximum duration of 24 hours. However, only a single pre-randomization dose of LMWH is allowed. After randomization, patients allocated to the rivaroxaban arm will receive rivaroxaban 10 mg once-daily started 6-10 hours provided haemostasis has been established after surgery or 24h hours after LMWH injection if needed for the intended treatment duration of 2 to 12 weeks based on medical judgment (according to immobilization). Patients allocated to the comparator arm will receive enoxaparin once daily for the same intended treatment duration. All patients will have a 30-day observational period after cessation of treatment.

status: Terminated

ReferenceCitation: Samama CM, Laporte S, Rosencher N, Girard P, Llau J, Mouret P, Fisher W, Martínez-Martín J, Duverger D, Deygas B, Presles E, Cucherat M, Mismetti P; PRONOMOS Investigators. Rivaroxaban or Enoxaparin in Nonmajor Orthopedic Surgery. N Engl J Med. 2020 May 14;382(20):1916-1925. doi: 10.1056/NEJMoa1913808. Epub 2020 Mar 29.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Hôpitaux Universitaires de Strasbourg C.C.O.M

location_facility: CHU Toulouse - Hôpital Pierre-Paul Riquet

status_simplified: Unknown


acronym: REGOBONE

title: A Randomized Phase II, Placebo-controlled, Multicenter Study Evaluating Efficacy and Safety of Regorafenib in Patients With Metastatic Bone Sarcomas

lead_sponsor: UNICANCER

ReferenceCitation: Duffaud F, Italiano A, Bompas E, Rios M, Penel N, Mir O, Piperno-Neumann S, Chevreau C, Delcambre C, Bertucci F, Boudou-Rouquette P, Cancel M, Perrin C, Saada-Bouzid E, Monard L, Schiffler C, Chaigneau L, Hervieu A, Collard O, Bouvier C, Vidal V, Chabaud S, Blay JY; French Sarcoma Group. Efficacy and safety of regorafenib in patients with metastatic or locally advanced chondrosarcoma: Results of a non-comparative, randomised, double-blind, placebo controlled, multicentre phase II study. Eur J Cancer. 2021 Jun;150:108-118. doi: 10.1016/j.ejca.2021.03.039. Epub 2021 Apr 22.

ReferenceCitation: Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14. Review.

ReferenceCitation: Duffaud F, Mir O, Boudou-Rouquette P, Piperno-Neumann S, Penel N, Bompas E, Delcambre C, Kalbacher E, Italiano A, Collard O, Chevreau C, Saada E, Isambert N, Delaye J, Schiffler C, Bouvier C, Vidal V, Chabaud S, Blay JY; French Sarcoma Group. Efficacy and safety of regorafenib in adult patients with metastatic osteosarcoma: a non-comparative, randomised, double-blind, placebo-controlled, phase 2 study. Lancet Oncol. 2019 Jan;20(1):120-133. doi: 10.1016/S1470-2045(18)30742-3. Epub 2018 Nov 23.

ipd_sharing_description: no individual participant data is shared

location_facility: Institut de Cancérologie Lucien Neuwirth (ICLN)

location_facility: Institut de cancerologie de l'ouest site Rene Gauducheau

location_facility: Institut de cancerologie de lorraine alexis Vautrin

summary:
INDICATION:

Metastatic bone sarcomas: conventional high grade osteosarcoma, Ewing sarcoma of bone, intermediate or high-grade chondrosarcomas and chordomas and either bone or soft tissue metastatic CIC-rearranged sarcomas


title: Phase II Randomized Trial Evaluting Aflibercept Associated With LV5FU2 Regimen as First Line Treatment of Non-resectalbe Metastatic Colorectal Cancers

acronym: FOLFA

summary: This is what the FFCD 11-01 - PRODIGE 25 trial proposes to study, as a preliminary for strategic studies evaluating the usefulness of including targeted therapeutics from the first line with aflibercept +/- LV5FU2.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: Institut de cancérologie de Bourgogne - GRRECC


title: PRessure suppOrT vEntilation + Sigh in aCuTe hypoxemIc respiratOry Failure patieNts (PROTECTION): a Pilot Randomized Controlled Trial

acronym: PROTECTION

summary:
Mortality of intubated acute hypoxemic respiratory failure (AHRF) and acute respiratory distress syndrome (ARDS) patients remains considerably high (around 40%) (Bellani 2016). Early implementation of a specific mechanical ventilation mode that enhances lung protection in patients with mild to moderate AHRF and ARDS on spontaneous breathing may have a tremendous impact on clinical practice.

Previous studies showed that the addition of cyclic short recruitment maneuvers (Sigh) to assisted mechanical ventilation: improves oxygenation without increasing ventilation pressures and FiO2; decreases the tidal volumes by decreasing the patient's inspiratory drive; increases the EELV by regional alveolar recruitment; decreases regional heterogeneity of lung parenchyma; decreases patients' inspiratory efforts limiting transpulmonary pressure; improves regional compliances. Thus, physiologic studies generated the hypothesis that addition of Sigh to pressure support ventilation (PSV, the most common assisted mechanical ventilation mode) might decrease ventilation pressures and FiO2, and limit regional lung strain and stress through various synergic mechanisms potentially yielding decreased risk of VILI, faster weaning and improved clinical outcomes.

The investigators conceived a pilot RCT to verify clinical feasibility of the addition of Sigh to PSV in comparison to standard PSV.

The investigators will enrol 258 intubated spontaneously breathing patients with mild to moderate AHRF and ARDS admitted to the ICU.

Patients will be randomized through an online automatic centralized and computerized system to the following study groups (1:1 ratio):

PSV group: will be treated by protective PSV settings until day 28 or death or performance of spontaneous breathing trial (SBT);
PSV+Sigh group: will be treated by protective PSV settings with the addition of Sigh until day 28 or death or performance of spontaneous breathing trial (SBT).

Indications on ventilation settings, weaning, spontaneous breathing trial and rescue treatment will be specified.

ReferenceCitation: Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291. Erratum in: JAMA. 2016 Jul 19;316(3):350. JAMA. 2016 Jul 19;316(3):350.

ReferenceCitation: Matthay MA, Ware LB, Zimmerman GA. The acute respiratory distress syndrome. J Clin Invest. 2012 Aug;122(8):2731-40. doi: 10.1172/JCI60331. Epub 2012 Aug 1. Review.

ReferenceCitation: Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2014 Mar 6;370(10):980. doi: 10.1056/NEJMc1400293.

ReferenceCitation: Mauri T, Foti G, Zanella A, Bombino M, Confalonieri A, Patroniti N, Bellani G, Pesenti A. Long-term extracorporeal membrane oxygenation with minimal ventilatory support: a new paradigm for severe ARDS? Minerva Anestesiol. 2012 Mar;78(3):385-9.

ReferenceCitation: Ranieri VM, Suter PM, Tortorella C, De Tullio R, Dayer JM, Brienza A, Bruno F, Slutsky AS. Effect of mechanical ventilation on inflammatory mediators in patients with acute respiratory distress syndrome: a randomized controlled trial. JAMA. 1999 Jul 7;282(1):54-61.

ReferenceCitation: Hussain SN, Cornachione AS, Guichon C, Al Khunaizi A, Leite Fde S, Petrof BJ, Mofarrahi M, Moroz N, de Varennes B, Goldberg P, Rassier DE. Prolonged controlled mechanical ventilation in humans triggers myofibrillar contractile dysfunction and myofilament protein loss in the diaphragm. Thorax. 2016 May;71(5):436-45. doi: 10.1136/thoraxjnl-2015-207559. Epub 2016 Mar 31.

ReferenceCitation: Papazian L, Forel JM, Gacouin A, Penot-Ragon C, Perrin G, Loundou A, Jaber S, Arnal JM, Perez D, Seghboyan JM, Constantin JM, Courant P, Lefrant JY, Guérin C, Prat G, Morange S, Roch A; ACURASYS Study Investigators. Neuromuscular blockers in early acute respiratory distress syndrome. N Engl J Med. 2010 Sep 16;363(12):1107-16. doi: 10.1056/NEJMoa1005372.

ReferenceCitation: Guérin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.

ReferenceCitation: Kallet RH, Matthay MA. Hyperoxic acute lung injury. Respir Care. 2013 Jan;58(1):123-41. doi: 10.4187/respcare.01963. Review.

ReferenceCitation: Bellani G, Guerra L, Musch G, Zanella A, Patroniti N, Mauri T, Messa C, Pesenti A. Lung regional metabolic activity and gas volume changes induced by tidal ventilation in patients with acute lung injury. Am J Respir Crit Care Med. 2011 May 1;183(9):1193-9. doi: 10.1164/rccm.201008-1318OC. Epub 2011 Jan 21.

ReferenceCitation: Yoshida T, Uchiyama A, Matsuura N, Mashimo T, Fujino Y. The comparison of spontaneous breathing and muscle paralysis in two different severities of experimental lung injury. Crit Care Med. 2013 Feb;41(2):536-45. doi: 10.1097/CCM.0b013e3182711972.

ReferenceCitation: Foti G, Cereda M, Sparacino ME, De Marchi L, Villa F, Pesenti A. Effects of periodic lung recruitment maneuvers on gas exchange and respiratory mechanics in mechanically ventilated acute respiratory distress syndrome (ARDS) patients. Intensive Care Med. 2000 May;26(5):501-7.

ReferenceCitation: Patroniti N, Foti G, Cortinovis B, Maggioni E, Bigatello LM, Cereda M, Pesenti A. Sigh improves gas exchange and lung volume in patients with acute respiratory distress syndrome undergoing pressure support ventilation. Anesthesiology. 2002 Apr;96(4):788-94.

ReferenceCitation: Nacoti M, Spagnolli E, Bonanomi E, Barbanti C, Cereda M, Fumagalli R. Sigh improves gas exchange and respiratory mechanics in children undergoing pressure support after major surgery. Minerva Anestesiol. 2012 Aug;78(8):920-9. Epub 2012 Apr 27.

ReferenceCitation: Mauri T, Eronia N, Abbruzzese C, Marcolin R, Coppadoro A, Spadaro S, Patroniti N, Bellani G, Pesenti A. Effects of Sigh on Regional Lung Strain and Ventilation Heterogeneity in Acute Respiratory Failure Patients Undergoing Assisted Mechanical Ventilation. Crit Care Med. 2015 Sep;43(9):1823-31. doi: 10.1097/CCM.0000000000001083.

ReferenceCitation: Tabuchi A, Nickles HT, Kim M, Semple JW, Koch E, Brochard L, Slutsky AS, Pries AR, Kuebler WM. Acute Lung Injury Causes Asynchronous Alveolar Ventilation That Can Be Corrected by Individual Sighs. Am J Respir Crit Care Med. 2016 Feb 15;193(4):396-406. doi: 10.1164/rccm.201505-0901OC.

ReferenceCitation: Güldner A, Braune A, Carvalho N, Beda A, Zeidler S, Wiedemann B, Wunderlich G, Andreeff M, Uhlig C, Spieth PM, Koch T, Pelosi P, Kotzerke J, de Abreu MG. Higher levels of spontaneous breathing induce lung recruitment and reduce global stress/strain in experimental lung injury. Anesthesiology. 2014 Mar;120(3):673-82. doi: 10.1097/ALN.0000000000000124.

ReferenceCitation: Moraes L, Santos CL, Santos RS, Cruz FF, Saddy F, Morales MM, Capelozzi VL, Silva PL, de Abreu MG, Garcia CS, Pelosi P, Rocco PR. Effects of sigh during pressure control and pressure support ventilation in pulmonary and extrapulmonary mild acute lung injury. Crit Care. 2014 Aug 12;18(4):474. doi: 10.1186/s13054-014-0474-4.

ReferenceCitation: Goligher EC, Kavanagh BP, Rubenfeld GD, Ferguson ND. Physiologic Responsiveness Should Guide Entry into Randomized Controlled Trials. Am J Respir Crit Care Med. 2015 Dec 15;192(12):1416-9. doi: 10.1164/rccm.201410-1832CP. Review.

ReferenceCitation: Riker RR, Fugate JE; Participants in the International Multi-disciplinary Consensus Conference on Multimodality Monitoring. Clinical monitoring scales in acute brain injury: assessment of coma, pain, agitation, and delirium. Neurocrit Care. 2014 Dec;21 Suppl 2:S27-37. doi: 10.1007/s12028-014-0025-5. Review.

ReferenceCitation: Goligher EC, Kavanagh BP, Rubenfeld GD, Adhikari NK, Pinto R, Fan E, Brochard LJ, Granton JT, Mercat A, Marie Richard JC, Chretien JM, Jones GL, Cook DJ, Stewart TE, Slutsky AS, Meade MO, Ferguson ND. Oxygenation response to positive end-expiratory pressure predicts mortality in acute respiratory distress syndrome. A secondary analysis of the LOVS and ExPress trials. Am J Respir Crit Care Med. 2014 Jul 1;190(1):70-6. doi: 10.1164/rccm.201404-0688OC.

ReferenceCitation: Girard TD, Kress JP, Fuchs BD, Thomason JW, Schweickert WD, Pun BT, Taichman DB, Dunn JG, Pohlman AS, Kinniry PA, Jackson JC, Canonico AE, Light RW, Shintani AK, Thompson JL, Gordon SM, Hall JB, Dittus RS, Bernard GR, Ely EW. Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised controlled trial. Lancet. 2008 Jan 12;371(9607):126-34. doi: 10.1016/S0140-6736(08)60105-1.

ReferenceCitation: Xirouchaki N, Kondili E, Vaporidi K, Xirouchakis G, Klimathianaki M, Gavriilidis G, Alexandopoulou E, Plataki M, Alexopoulou C, Georgopoulos D. Proportional assist ventilation with load-adjustable gain factors in critically ill patients: comparison with pressure support. Intensive Care Med. 2008 Nov;34(11):2026-34. doi: 10.1007/s00134-008-1209-2. Epub 2008 Jul 8.

ReferenceType: result

ReferenceCitation: Peek GJ, Mugford M, Tiruvoipati R, Wilson A, Allen E, Thalanany MM, Hibbert CL, Truesdale A, Clemens F, Cooper N, Firmin RK, Elbourne D; CESAR trial collaboration. Efficacy and economic assessment of conventional ventilatory support versus extracorporeal membrane oxygenation for severe adult respiratory failure (CESAR): a multicentre randomised controlled trial. Lancet. 2009 Oct 17;374(9698):1351-63. doi: 10.1016/S0140-6736(09)61069-2. Epub 2009 Sep 15. Erratum in: Lancet. 2009 Oct 17;374(9698):1330.

ReferenceCitation: Mauri T, Foti G, Fornari C, Grasselli G, Pinciroli R, Lovisari F, Tubiolo D, Volta CA, Spadaro S, Rona R, Rondelli E, Navalesi P, Garofalo E, Knafelj R, Gorjup V, Colombo R, Cortegiani A, Zhou JX, D'Andrea R, Calamai I, Vidal González Á, Roca O, Grieco DL, Jovaisa T, Bampalis D, Becher T, Battaglini D, Ge H, Luz M, Constantin JM, Ranieri M, Guerin C, Mancebo J, Pelosi P, Fumagalli R, Brochard L, Pesenti A; PROTECTION Trial Collaborators. Sigh in Patients With Acute Hypoxemic Respiratory Failure and ARDS: The PROTECTION Pilot Randomized Clinical Trial. Chest. 2021 Apr;159(4):1426-1436. doi: 10.1016/j.chest.2020.10.079. Epub 2020 Nov 13.

ReferenceCitation: Mauri T, Foti G, Fornari C, Constantin JM, Guerin C, Pelosi P, Ranieri M, Conti S, Tubiolo D, Rondelli E, Lovisari F, Fossali T, Spadaro S, Grieco DL, Navalesi P, Calamai I, Becher T, Roca O, Wang YM, Knafelj R, Cortegiani A, Mancebo J, Brochard L, Pesenti A; Protection Study Group. Pressure support ventilation + sigh in acute hypoxemic respiratory failure patients: study protocol for a pilot randomized controlled trial, the PROTECTION trial. Trials. 2018 Aug 29;19(1):460. doi: 10.1186/s13063-018-2828-8.

lead_sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

location_country:
Spain
Italy
Greece
United Kingdom
France
China
Germany

location_facility: UNIVERSITÄTSKLINIKUM Schleswig-Holstein Campus Kiel

location_facility: Barking, Havering and Redbridge Hospital

intervention_type: Procedure


title: Initiation of Non- Invasive Ventilation at Home Versus Hospital Among Patients With Overlap Syndrome: Randomized Controlled Non-inferiority Study

acronym: OVNI-Dom

summary: The study is based on the assumption that in the Overlap Syndrome, the introduction at home of the NIV is as effective in terms of compliance and clinical and gazometric improvement, and life quality, that setting hospital start up. The investigators will study the initiation of NIV at home versus in hospital in two randomized Overlap Syndrome patient groups. The main objective of the study is to demonstrate the non-inferiority of the initiation of the NIV at home versus hospital in terms of compliance.

status: Unknown status

lead_sponsor: IP Santé Domicile

location_facility: CHU de Grenoble site Nord - Hôpital Albert Michallon


title: A Double-Blind, Randomized, Placebo-controlled Multicenter Trial of GRanulocyte-Macrophage Colony-stimulating Factor Administration to Decrease ICU Acquired Infections in Sepsis-induced ImmunoDepression

acronym: GRID

summary:
The concept of acquired immunodeficiency after a first severe infection in the ICU is widely described in the literature. There is a dual risk: increased mortality and increased secondary infections. Several approaches of immunostimulatory treatments have been proposed in the literature. The treatment proposed by this study consists of the administration of Granulocyte-macrophage colony-stimulating factor (GM-CSF), colony stimulating factor widely used particularly in the USA where it is marketed. A phase 2 clinical trial was conducted in Germany in 2009.

The main objective is to measure the incidence of ICU-acquired infections in 2 groups of patients treated by GM-CSF or placebo. ICU patients at risk are defined as surviving at D3 from a severe sepsis or septic shock and presenting a sepsis associated immunodepression. The detection of immunosuppressed patients will be achieved by measuring the HLA-DR (Human Leucocyte Antigen DR)with a threshold of less to 8000 sites.

Our hypothesis is that the number of secondary infections (primary endpoint) will be significantly reduced in the treated group.

lead_sponsor: Hospices Civils de Lyon

location_facility: CHU Estaing 1 place Lucie et Raymond Aubrac


title: Randomised Phase II Study in Metastatic Pancreatic Cancer Evaluating FOLFIRINOX +/- LV5FU2 in Maintenance Versus Firgem in First-line

acronym: PANOPTIMOX

summary:
The pancreas cancer is the 4th cause of death. All stage confused, the survival at 5 years is note over 5 %. At metastatic stage, the pancreatic adenocarcinoma is an incurable disease with the survival median of 2-4 months without chemotherapy.

Up to 2011, gemcitabine was the only reference treatment of this type of cancer. But until, the FOLFIRINOX could permitted to improve significantly the overall survival (6,8 months with gemcitabine vs 11,1 months with FOLFIRINOX) and the progression free survival (3,3 months with gemcitabine vs 6,4 months with FOLFIRINOX) for patients under 76 years. Main toxicities of this treatment are hematological, gastrointestinal and neuropathy with apparition of sensitive neuropathy, reversible, related to oxaliplatin.

These results are on a population under 76 years old. In this study, the median age of patients at inclusion was 61 years old and FOLFIRINOX was still beneficial for patients more than 65 years old. Given the increase of proportion of patients than more of 65 years old with pancreatic cancer and given the increase of life expected, it is important to know the effectiveness and tolerance of such treatment for patient older than 65 years and 76 years.

FIRGEM is an original strategic sequential treatment witch alternates, every 2 month, 4 cycles of FOLFIRI.3 and 2 cycles of 3 injections of gemcitabine. There is no cross resistance known between this 2 treatments witch limit toxicities and preserve quality of life of patients. A Phase II trial testing this treatment regimen to classical regimen of gemecitabine, showed an overall survival of 11 months in the FIRGEM regimen and an overall survival of 8,2 months in the gemcitabine regimen. The rate of progression was 45% near of progression rate with FOLFIRINOX. Tolerance is close to that FOLFIRINOX regimen but this strategic doesn't induce limiting neurotoxicities and allow to use oxaliplatin in 2de line of treatment.

The trial propose to evaluate the effectiveness and tolerance of FOLFIRINOX regimen (8 cycles) with LV5FU2 in maintenance (that could increase the FOLFIRINOX tolerable without decrease efficiency), to FIRGEM regimen and to FOLFIRINOX (12 cycles) which is the reference regimen.

ReferenceCitation: Dahan L, Williet N, Le Malicot K, Phelip JM, Desrame J, Bouché O, Petorin C, Malka D, Rebischung C, Aparicio T, Lecaille C, Rinaldi Y, Turpin A, Bignon AL, Bachet JB, Seitz JF, Lepage C, François E; PRODIGE 35 Investigators/Collaborators. Randomized Phase II Trial Evaluating Two Sequential Treatments in First Line of Metastatic Pancreatic Cancer: Results of the PANOPTIMOX-PRODIGE 35 Trial. J Clin Oncol. 2021 Oct 10;39(29):3242-3250. doi: 10.1200/JCO.20.03329. Epub 2021 Jul 21.

ipd_sharing: Undecided

location_facility: CHU AP - HP - Hôpital Européen Georges Pompidou

location_facility: Institut Daniel Hollard / Groupe Hospitalier Mutualiste

location_facility: Hôpital de la Source -service HGE et cancérologie digestive

location_facility: Hôpital de la Source- service d'oncologie


title: Multicenter Prospective and Observational Cohort of Respiratory Failure Patients Treated for the First Time With Non-invasive Ventilation (NIV) at Home

summary:
The effectiveness of NIV is clearly demonstrated but no recent studies describe the prescription based on clinical data and the conditions of using NIV at home according the various respiratory diseases.

The investigators' purpose is that a better knowledge of NIV practices could improve both the quality to support patients at home and the efficacy of the treatment.

The main objective of this study is to analyze the clinical data justifying the prescription of NIV advice according respiratory disease. The secondary objectives are to study comorbidities, treatment failures, survival rate during the study period.

lead_sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

location_facility:
CH de Cannes
Hôpital Edouard Rist
CHU de Rouen
Hôpital Robert Schuman
Garches
CHU d'Angers
CHU de Grenoble
CHU de Dijon
CHD de la Réunion
CHU de Nancy
CHU de Strasbourg
CHU de Toulouse
CHU de Limoges
CHU de Lille
AP-HP Pitié-Salpêtrière
CHU de Besançon

intervention_type: Device


acronym: EUROPE

title: PROSPECTIVE VALIDATION OF A PREDICTIVE MODEL OF RESPONSE TO ROMIPLOSTIM IN PATIENTS WITH IPSS LOW OR INTERMEDIATE-1 RISK MYELODYSPLASTIC SYNDROME (MDS) AND THROMBOCYTOPENIA - THE EUROPE-TRIAL

lead_sponsor: Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

design_allocation: Non-Randomized

location_facility: Marienhospital Düsseldorf GmbH / Innere Medizin u. Hämatologie

location_facility: Rems-Murr-Kliniken Winnenden / Hämatologie, Onkologie

location_facility: Universitätsklinikum Ulm / Klinik Innere Medizin III

location_facility: Universitätsklinikum Halle (Saale) / Klinik für Innere Medizin IV

location_facility: Universitätsklinikum Dresden / Medizinische Klinik I

location_facility: Universitätsklinikum Mannheim / Klinik III / Hämatologie, Onkologie

location_facility: MVZ Onkologischer Schwerpunkt am Oskar-Helene-Heim

location_facility: Klinikum Chemnitz gGmbH / Klinik für Innere Medizin III

location_facility: Klinikum Rechts der Isar, Tumortherapiezentrum

location_facility: Universitätsklinikum Hamburg-Eppendorf /Onkologisches Zentrum

location_facility: Vivantes Klinikum am Urban / Hämatologie Onkologie

location_facility: Medizinische Hochschule Hannover / Hämatologie u. Onkologie

summary: There are currently no licensed drugs in the EU to treat thrombocytopenia in MDS patients classified as IPSS low/int-1. Prior studies with romiplostim (a TPO receptor agonist) in MDS found that baseline concentration of TPO as well as transfusion history were predictive of subsequent response in a retrospective model. The current prospective study has the aim to explore whether both pretreatment variables (endogenous TPO, TPO-level, platelet transfusion history) can predict the response to subsequent short-term treatment with romiplostim.


type: Other Identifier

title: Multicentre, Randomized, Parallel Group, Non-inferiority, Open-label Study Aiming at Comparing the Healing Rates (With Blinded Assessment Based on Photographs) of TULLEGRAS M.S.® With URGOTUL® in the Treatment of Surgical Acute Wounds.

summary: Evaluation of non-inferiority on healing rates of two dressings Urgotul and TulleGras MS in the treatment of surgical acute wounds.

lead_sponsor: Mylan Inc.

location_facility:
Research facility ORG-001093
Research facility ID ORG-001220
Research facility ORG-001090
Research facility ORG-001089
Research facility ORG-001088
Research facility ID ORG-001263
Research facility ORG-001133
Research facility ORG-001360
Research facility ORG-001099
Research facility ORG-001097
Research facility ID ORG-001105
Research facility ID ORG-001099
Research facility ORG-001107
Research facility ID ORG-001088
Research facility ID ORG-001134
Research facility ORG-001136
Research facility ID ORG-001276
Research facility ORG-001105
Research facility ID ORG-001190
Research facility ID ORG-001189
Research facility ID ORG-001278
Research facility ID ORG-001265
Research facility ORG-001166
Research facility ID ORG-001221
Research facility ORG-001096
Research facility ID ORG-001133
Research facility ID ORG-001223
Research facility ORG-001137
Research facility ID ORG-001264
Research facility ORG-001132
Research facility ORG-001102
Research facility ORG-001101
Research facility ID ORG-001222


title: Interest of Pre-hospital Administration of Lyophilized Plasma to Prevent or Treat Coagulopathy Associated With Post-traumatic Hemorrhagic Shock (PREHO-PLYO Study )

acronym: PREHO-PLYO

summary:
In severe bleeding due to trauma, a decrease in coagulation factors maintains and promotes bleeding. The plasma allows, through its contribution of coagulation factors, early prevention or correction of this post-trauma induced coagulopathy. This study aims to measure the effectiveness of pre-hospital FLYP administration in case of traumatic hemorrhagic shock, in the occurrence or the treatment of a post traumatic induced coagulopathy.

Study Design

This is a randomized controlled multicenter open label study in two parallel groups.

Eligibility criteria : adult, victim of a hemorrhagic shock of traumatic origin with [systolic blood pressure <70 mmHg] or Shock Index >1.1 The patients will receive either FLYP either the usual treatment as given in the recommendations for best practice.

The primary endpoint is the International Normalized Ratio (INR) at hospital admission.

The study must confirm the link between causality of early administration of plasma in improving post-traumatic coagulopathy. The study must show safe usage in out-of-hospital situations and the ability of medical staff to meet the requirements of the health authorities in terms of product use as well as in terms of traceability of the victims and the treatment they received.

ReferenceCitation: Boutonnet M, Pasquier P, Salvadori A, Auroy Y, Tourtier JP. Advocacy to extend the use of continuous noninvasive hemoglobin measurement. Crit Care Med. 2011 Dec;39(12):2783-4; author reply 2784-5. doi: 10.1097/CCM.0b013e31822b3a22.

ReferenceCitation: Pasquier P, Boutonnet M, Giraud N, Salvadori A, Tourtier JP. Hypotension redefined, shock index and massive transfusion. J Trauma. 2011 Sep;71(3):784-5. doi: 10.1097/TA.0b013e318228b83d.

ReferenceCitation: Brohi K, Singh J, Heron M, Coats T. Acute traumatic coagulopathy. J Trauma. 2003 Jun;54(6):1127-30.

ReferenceCitation: Martinaud C, Tourtier JP, Pasquier P, Ausset S, Sailliol A. The French freeze-dried plasma. J Trauma. 2011 Oct;71(4):1091-2. doi: 10.1097/TA.0b013e31822a8fd5.

ReferenceCitation: Martinaud C, Ausset S, Deshayes AV, Cauet A, Demazeau N, Sailliol A. Use of freeze-dried plasma in French intensive care unit in Afghanistan. J Trauma. 2011 Dec;71(6):1761-4; discussion 1764-5. doi: 10.1097/TA.0b013e31822f1285.

ReferenceCitation: Sailliol A, Martinaud C, Cap AP, Civadier C, Clavier B, Deshayes AV, Mendes AC, Pouget T, Demazeau N, Chueca M, Martelet FR, Ausset S. The evolving role of lyophilized plasma in remote damage control resuscitation in the French Armed Forces Health Service. Transfusion. 2013 Jan;53 Suppl 1:65S-71S. doi: 10.1111/trf.12038.

ReferenceCitation: Martinaud C, Civadier C, Ausset S, Verret C, Deshayes AV, Sailliol A. In vitro hemostatic properties of French lyophilized plasma. Anesthesiology. 2012 Aug;117(2):339-46. doi: 10.1097/ALN.0b013e3182608cdd.

ReferenceCitation: Glassberg E, Nadler R, Gendler S, Abramovich A, Spinella PC, Gerhardt RT, Holcomb JB, Kreiss Y. Freeze-dried plasma at the point of injury: from concept to doctrine. Shock. 2013 Dec;40(6):444-50. doi: 10.1097/SHK.0000000000000047. Review. Erratum in: Shock. 2014 Feb;41(2):172.

ReferenceCitation: Brown JB, Guyette FX, Neal MD, Claridge JA, Daley BJ, Harbrecht BG, Miller RS, Phelan HA, Adams PW, Early BJ, Peitzman AB, Billiar TR, Sperry JL. Taking the Blood Bank to the Field: The Design and Rationale of the Prehospital Air Medical Plasma (PAMPer) Trial. Prehosp Emerg Care. 2015 Jul-Sep;19(3):343-50. doi: 10.3109/10903127.2014.995851. Epub 2015 Feb 6.

ReferenceCitation: Kim BD, Zielinski MD, Jenkins DH, Schiller HJ, Berns KS, Zietlow SP. The effects of prehospital plasma on patients with injury: a prehospital plasma resuscitation. J Trauma Acute Care Surg. 2012 Aug;73(2 Suppl 1):S49-53. doi: 10.1097/TA.0b013e31826060ff.

ReferenceCitation: Chapman MP, Moore EE, Moore HB, Gonzalez E, Morton AP, Chandler J, Fleming CD, Ghasabyan A, Silliman CC, Banerjee A, Sauaia A. The "Death Diamond": Rapid thrombelastography identifies lethal hyperfibrinolysis. J Trauma Acute Care Surg. 2015 Dec;79(6):925-9. doi: 10.1097/TA.0000000000000871.

ReferenceCitation: Floccard B, Rugeri L, Faure A, Saint Denis M, Boyle EM, Peguet O, Levrat A, Guillaume C, Marcotte G, Vulliez A, Hautin E, David JS, Négrier C, Allaouchiche B. Early coagulopathy in trauma patients: an on-scene and hospital admission study. Injury. 2012 Jan;43(1):26-32. doi: 10.1016/j.injury.2010.11.003. Epub 2010 Nov 26.

ReferenceCitation: Borgman MA, Spinella PC, Perkins JG, Grathwohl KW, Repine T, Beekley AC, Sebesta J, Jenkins D, Wade CE, Holcomb JB. The ratio of blood products transfused affects mortality in patients receiving massive transfusions at a combat support hospital. J Trauma. 2007 Oct;63(4):805-13.

ReferenceCitation: de Biasi AR, Stansbury LG, Dutton RP, Stein DM, Scalea TM, Hess JR. Blood product use in trauma resuscitation: plasma deficit versus plasma ratio as predictors of mortality in trauma (CME). Transfusion. 2011 Sep;51(9):1925-32. doi: 10.1111/j.1537-2995.2010.03050.x. Epub 2011 Feb 18.

ReferenceCitation: Peltan ID, Vande Vusse LK, Maier RV, Watkins TR. An International Normalized Ratio-Based Definition of Acute Traumatic Coagulopathy Is Associated With Mortality, Venous Thromboembolism, and Multiple Organ Failure After Injury. Crit Care Med. 2015 Jul;43(7):1429-38. doi: 10.1097/CCM.0000000000000981.

ReferenceCitation: Holcomb JB, Tilley BC, Baraniuk S, Fox EE, Wade CE, Podbielski JM, del Junco DJ, Brasel KJ, Bulger EM, Callcut RA, Cohen MJ, Cotton BA, Fabian TC, Inaba K, Kerby JD, Muskat P, O'Keeffe T, Rizoli S, Robinson BR, Scalea TM, Schreiber MA, Stein DM, Weinberg JA, Callum JL, Hess JR, Matijevic N, Miller CN, Pittet JF, Hoyt DB, Pearson GD, Leroux B, van Belle G; PROPPR Study Group. Transfusion of plasma, platelets, and red blood cells in a 1:1:1 vs a 1:1:2 ratio and mortality in patients with severe trauma: the PROPPR randomized clinical trial. JAMA. 2015 Feb 3;313(5):471-82. doi: 10.1001/jama.2015.12.

ReferenceCitation: Sunde GA, Vikenes B, Strandenes G, Flo KC, Hervig TA, Kristoffersen EK, Heltne JK. Freeze dried plasma and fresh red blood cells for civilian prehospital hemorrhagic shock resuscitation. J Trauma Acute Care Surg. 2015 Jun;78(6 Suppl 1):S26-30. doi: 10.1097/TA.0000000000000633.

ReferenceCitation: Moore HB, Moore EE, Morton AP, Gonzalez E, Fragoso M, Chapman MP, Dzieciatkowska M, Hansen KC, Banerjee A, Sauaia A, Silliman CC. Shock-induced systemic hyperfibrinolysis is attenuated by plasma-first resuscitation. J Trauma Acute Care Surg. 2015 Dec;79(6):897-903; discussion 903-4. doi: 10.1097/TA.0000000000000792.

ReferenceCitation: Rugeri L, Levrat A, David JS, Delecroix E, Floccard B, Gros A, Allaouchiche B, Negrier C. Diagnosis of early coagulation abnormalities in trauma patients by rotation thrombelastography. J Thromb Haemost. 2007 Feb;5(2):289-95. Epub 2006 Nov 16.

ReferenceCitation: Jost D, Lemoine S, Lemoine F, Derkenne C, Beaume S, Lanoë V, Maurin O, Louis-Delaurière E, Delacote M, Dang-Minh P, Franchin-Frattini M, Bihannic R, Savary D, Levrat A, Baudouin C, Trichereau J, Salomé M, Frattini B, Ha VHT, Jouffroy R, Seguineau E, Titreville R, Roquet F, Stibbe O, Vivien B, Verret C, Bignand M, Travers S, Martinaud C, Arock M, Raux M, Prunet B, Ausset S, Sailliol A, Tourtier JP; Prehospital Lyophilized Plasma (PREHO-PLYO) Study Group. Prehospital Lyophilized Plasma Transfusion for Trauma-Induced Coagulopathy in Patients at Risk for Hemorrhagic Shock: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jul 1;5(7):e2223619. doi: 10.1001/jamanetworkopen.2022.23619.

ReferenceCitation: Jost D, Lemoine S, Lemoine F, Lanoe V, Maurin O, Derkenne C, Franchin Frattini M, Delacote M, Seguineau E, Godefroy A, Hervault N, Delhaye L, Pouliquen N, Louis-Delauriere E, Trichereau J, Roquet F, Salomé M, Verret C, Bihannic R, Jouffroy R, Frattini B, Hong Tuan Ha V, Dang-Minh P, Travers S, Bignand M, Martinaud C, Garrabe E, Ausset S, Prunet B, Sailliol A, Tourtier JP; PREHO-PLYO Study Group. French lyophilized plasma versus normal saline for post-traumatic coagulopathy prevention and correction: PREHO-PLYO protocol for a multicenter randomized controlled clinical trial. Trials. 2020 Jan 22;21(1):106. doi: 10.1186/s13063-020-4049-1.

lead_sponsor: French Defence Health Service

location_facility: Hopital d'Instruction des Armées LAVERAN

location_facility: Hopital des Instructions des Armées BEGIN

location_facility: Fire Brigade Of Paris Emergency Medicine Dept

location_facility: Bataillon des marins-pompiers de Marseille

location_facility: Centre de Transfusion Sanguine des Armées


title: A Multicenter Open Label Phase 2 Study of Carfilzomib Weekly Plus Melphalan and Prednisone in Untreated Symptomatic Elderly Multiple Myeloma

summary: IFM 2012-03 protocol is a Phase 2 multicenter nonrandomized open in elderly patients with multiple myeloma at diagnosis. Study primary objectives are in the first step to determine Maximum tolerated dose (MTD) of Carfilzomib Weekly based on definition of Dose-limiting toxicities (DLTs) and in the second step to expanded cohort, to determine the VGPR (Very Good Partial Response) + CR (Complete Response) rate of Carfilzomib Weekly at the MTD in combination with Melphalan Prednisone at the end of the 9 induction cycles.

lead_sponsor: University Hospital, Lille

location_facility: Hématologie Clinique, CHU, Hôpital d'Enfants

location_facility: Hématologie Clinique, Hôpital Robert Debré, CHU Reims

location_facility: Unité de Recherche Clinique - CH Perigueux

location_facility: Centre hospitalier départemental La Roche sur Yon


title: PERSONALIZED MEDICINE GROUP / UCBG UC-0105/1304: SAFIR02_Breast - Evaluation of the Efficacy of High Throughput Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer

ReferenceCitation: Mosele F, Stefanovska B, Lusque A, Tran Dien A, Garberis I, Droin N, Le Tourneau C, Sablin MP, Lacroix L, Enrico D, Miran I, Jovelet C, Bièche I, Soria JC, Bertucci F, Bonnefoi H, Campone M, Dalenc F, Bachelot T, Jacquet A, Jimenez M, André F. Outcome and molecular landscape of patients with PIK3CA-mutated metastatic breast cancer. Ann Oncol. 2020 Mar;31(3):377-386. doi: 10.1016/j.annonc.2019.11.006. Epub 2020 Jan 24.

location_facility: Institut Régional du Cancer Montpellier Val d'Aurelle

location_facility: Hopitaux Universitaire de Strasbourg - Hopital Civil

location_facility: Institut de Cancérologie de l'Ouest/ René Gauducheau

location_facility: Institut de Cancérologie de l'Ouest/Paul Papin

summary: Open label multicentric phase II randomized trial, using high throughput genome analysis as a therapeutic decision tool, which aims at comparing a targeted treatment administered according to the identified molecular anomalies of the tumor with maintenance chemotherapy (targeted substudy 1) as well as immunotherapy with maintenance chemotherapy in patients without actionable genomic alterations or non eligible to substudy 1 (immune substudy 2).


title: Evolution of Neuropathies Associated With Necrotizing Vasculitis: Prospective, Non-interventional, Multicentric Study

acronym: NERF-VASC

summary:
Necrotizing Vasculitis are inflammatory diseases of the wall of vessels. Neurological damage of the peripheral nerve varies from 7% to 50% of cases depending on the type of Necrotizing Vasculitis.

Peripheral neurological impairment is rarely life threatening (except when associated with other visceral impairment which, in turn, require urgent management with a severity score defined by the Five Factor Score) but impacts the functional outcome by sequelae evaluated by the Vascular Disease Index (VDI).

Four retrospective studies were published with low number of participants, and also mix subgroups of vasculitis Anti-Neutrophil Cytoplasmatic Antibodies (ANCA)+/- GPA (Granulomatosis with polyangiitis), Eosinophilic granulomatosis with polyangiitis (EGPA), Microscopic polyangiitis (MPA), Polyarteritis nodosa (PAN), and Non Systemic Vasculitic Neuropathy (NSVN) and Systemic Vasculitic Neuropathy (SVN).

Overall, management of Necrotizing Vasculitis has evolved significantly over the last two decades, with a dramatic improvement in survival, thanks to new therapeutic strategies and medications. Five-year survival increased from 85% for diagnoses made between 1990 and 1999 to 94.5% for diagnoses made after 2010 Evaluation of relapses of vasculitis, late macro vascular complications, medical-economic evaluation of therapeutic strategies and functional impairment of neuropathies are at the heart of current medical concerns with a view to improve vital and functional prognosis.

Various tests for the evaluation of peripheral neurological damage appear to be relevant tools in vasculitis, although they are not specific: Muscular force scale Medical research council (MRC), Rasch-built overall disability scale (RODS), Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, Construction and validation of the chronic acquired polyneuropathy patient-reported index (CAP-PRI), Health-Related Quality of Life (HR QOL), Medical Interview Satisfaction Scale (MISS), Neuropsychological Impairment Scale (NIS) associated to results of repeated Electromyography.

In this study, MRC, NIS and RODS measurements were chosen for their reproducibility and practicality.

In addition to the immediate or relapse mortality factors assessed by the five-factor score (FFS), a functional morbidity score specific to neuropathies related to necrotizing vasculitis must be developed, as well as the determination of the neurosensory disorders and macro-vascular complications. Therefore it is proposed in this observational study to determine the factors that can be predictive of the functional evolution, in order to build a risk score.

lead_sponsor: Lille Catholic University

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Hôpital Edouard Herriot - Hospices Civils de Lyon

location_facility: Hôpital Neurologique Pierre Wertheimer - Hospices Civils de Lyon


title: Retrospective Multicenter Observational Study in NSCLC Patients With Epidermal Growth Factor Receptor (EGFR) Activating Mutation Treated First Line by Tyrosine Kinase Inhibitor (TKI)

acronym: EGFR-RETRO

summary: The purpose of our retrospective study is to describe which circumstances EGFR TKI is continued despite progression according to the usual Response Evaluation CrIteria in Solid Tumours (RECIST) in patients with EGFR activating mutations and acquired resistance to EGFR TKI .We will collect their social and demographic data (age, sex), first Progression Free Survival ( PFS) - from start of EGFR TKI to 1st progression PFS 1- and - from first progression according to RECIST to second progression : PFS2- , Overall Survival (OS) - from diagnosis OS 1 and from first progression OS 2 -, mutational status. We will analyze more closely the mode of progression (site), the therapeutic approach at disease progression. We will define two subgroups: those for whom EGFR TKI was continued at least three months despite progression defined according to RECIST criteria, and those for whom a second-line treatment (chemotherapy without EGFR TKI) was chosen at disease progression. It will be individualized the subgroup of patients in whom it was continued TKI after progression.

time_perspective: Retrospective

ReferenceCitation: Auliac JB, Fournier C, Audigier Valette C, Perol M, Bizieux A, Vinas F, Decroisette Phan van Ho C, Bota Ouchlif S, Corre R, Le Garff G, Fournel P, Baize N, Lamy R, Vergnenegre A, Arpin D, Marin B, Chouaid C, Gervais R. Impact of Continuing First-Line EGFR Tyrosine Kinase Inhibitor Therapy Beyond RECIST Disease Progression in Patients with Advanced EGFR-Mutated Non-Small-Cell Lung Cancer (NSCLC): Retrospective GFPC 04-13 Study. Target Oncol. 2016 Apr;11(2):167-74. doi: 10.1007/s11523-015-0387-4.

lead_sponsor: Groupe Francais De Pneumo-Cancerologie

location_facility:
Site 19
Site 32
Site 25
Centre François Baclesse
Centre Hospitalier Universitaire
Site 12
Site 14
Centre Hospitalier Les Oudairies
Site 20
Centre Hospitalier du Morvan
Site 11
Site 00
Site 04
Hôpital Yves Le Foll
Site 01
Site 06
Centre Hospitalier René Dubos
Site 18
Site 33
Site 17
Centre Hospitalier D Argenteuil
Site 07
Hospital du Cluzeau
Centre Hospitalier Régional


title: Impact of the Choice of the Distal Vertebral When Posterior Instrumentation in the Surgery of the Thoracic Adolescent Idiopathic Scoliosis

acronym: VD-SIA

summary:
The problem of choosing the supporting vertebra was the subject of several studies. They do not suggest as regards the techniques that are not currently used or with insufficient setback.

The need to have a sufficient number of files with a minimum decline of 5 years for proposing a multicenter study that will be conducted within the framework of the Scoliosis Research Group (SRG) and will result in a roundtable at the next congress GES in March 2015. the GES gathers most of the teams that support this pathology.

primary_purpose: Other

lead_sponsor: Fondation Lenval

location_country: Lebanon France

location_facility: Hotel Dieu De France Hospital Youssef Souda

location_facility: Clinique Chirurgicale Infantile, Hôpital Charles Nicolle, CHU de Rouen

location_facility: Institut François Calot/Centre Hélio-Marin

location_facility: Groupe Hospitalier Sud Réunion Terre Rouge Boissy

location_facility: Chirurgie infantile, Hôpital mère-enfant pédiatrie, CHU Nantes

location_facility: Centre du rachis, Maison de Spécialistes de Trélazé, sur le site du Village Santé Angers Loire

location_facility: Fondation LENVAL, Hôpitaux Pédiatriques de Nice CHU-LENVAL


acronym: SWIFT DIRECT

summary:
Intravenous thrombolysis with recombinant tissue-type plasminogen activator (IV t-PA) has been the only proven therapy for acute ischemic stroke (AIS) for almost 20 years. Whether IV t-PA prior to endovascular clot retrieval is beneficial for AIS patients with a proximal vessel occlusion in the anterior circulation has currently become a matter of debate and is a relevant unanswered question in clinical practice.

The main objective is to determine whether subjects experiencing an AIS due to large intracranial vessel occlusion in the anterior circulation will have non-inferior functional outcome at 90 days when treated with direct mechanical thrombectomy (MT) compared to subjects treated with combined IV t-PA and MT.

The secondary objectives are to study causes of mortality, dependency and quality of life in these AIS patients.

ReferenceCitation: Mujanovic A, Eker O, Marnat G, Strbian D, Ijäs P, Préterre C, Triquenot A, Albucher JF, Gauberti M, Weisenburger-Lile D, Ernst M, Nikoubashman O, Mpotsaris A, Gory B, Tuan Hua V, Ribo M, Liebeskind DS, Dobrocky T, Meinel TR, Buetikofer L, Gralla J, Fischer U, Kaesmacher J; SWIFT DIRECT investigators. Association of intravenous thrombolysis and pre-interventional reperfusion: a post hoc analysis of the SWIFT DIRECT trial. J Neurointerv Surg. 2022 Nov 17. pii: jnis-2022-019585. doi: 10.1136/jnis-2022-019585. [Epub ahead of print]

ReferenceCitation: Meinel TR, Kaesmacher J, Buetikofer L, Strbian D, Eker OF, Cognard C, Mordasini P, Deppeler S, Mendes Pereira V, Albucher JF, Darcourt J, Bourcier R, Guillon B, Papagiannaki C, Costentin G, Sibolt G, Räty S, Gory B, Richard S, Liman J, Ernst M, Boulanger M, Barbier C, Mechtouff L, Zhang L, Marnat G, Sibon I, Nikoubashman O, Reich A, Consoli A, Weisenburger D, Requena M, Garcia-Tornel A, Saleme S, Moulin S, Pagano P, Saliou G, Carrera E, Janot K, Boix M, Pop R, Della Schiava L, Luft A, Piotin M, Gentric JC, Pikula A, Pfeilschifter W, Arnold M, Siddiqui A, Froehler MT, Furlan AJ, Chapot R, Wiesmann M, Machi P, Diener HC, Kulcsar Z, Bonati L, Bassetti C, Escalard S, Liebeskind D, Saver JL, Fischer U, Gralla J; SWIFT-DIRECT investigators. Time to treatment with bridging intravenous alteplase before endovascular treatment:subanalysis of the randomized controlled SWIFT-DIRECT trial. J Neurointerv Surg. 2022 Jul 28. pii: neurintsurg-2022-019207. doi: 10.1136/jnis-2022-019207. [Epub ahead of print]

ReferenceCitation: Fischer U, Kaesmacher J, Strbian D, Eker O, Cognard C, Plattner PS, Bütikofer L, Mordasini P, Deppeler S, Pereira VM, Albucher JF, Darcourt J, Bourcier R, Benoit G, Papagiannaki C, Ozkul-Wermester O, Sibolt G, Tiainen M, Gory B, Richard S, Liman J, Ernst MS, Boulanger M, Barbier C, Mechtouff L, Zhang L, Marnat G, Sibon I, Nikoubashman O, Reich A, Consoli A, Lapergue B, Ribo M, Tomasello A, Saleme S, Macian F, Moulin S, Pagano P, Saliou G, Carrera E, Janot K, Hernández-Pérez M, Pop R, Schiava LD, Luft AR, Piotin M, Gentric JC, Pikula A, Pfeilschifter W, Arnold M, Siddiqui AH, Froehler MT, Furlan AJ, Chapot R, Wiesmann M, Machi P, Diener HC, Kulcsar Z, Bonati LH, Bassetti CL, Mazighi M, Liebeskind DS, Saver JL, Gralla J; SWIFT DIRECT Collaborators. Thrombectomy alone versus intravenous alteplase plus thrombectomy in patients with stroke: an open-label, blinded-outcome, randomised non-inferiority trial. Lancet. 2022 Jul 9;400(10346):104-115. doi: 10.1016/S0140-6736(22)00537-2.

ReferenceCitation: Fischer U, Kaesmacher J, S Plattner P, Bütikofer L, Mordasini P, Deppeler S, Cognard C, Pereira VM, Siddiqui AH, Froehler MT, Furlan AJ, Chapot R, Strbian D, Wiesmann M, Bressan J, Lerch S, Liebeskind DS, Saver JL, Gralla J; SWIFT DIRECT study investigators. SWIFT DIRECT: Solitaire™ With the Intention For Thrombectomy Plus Intravenous t-PA Versus DIRECT Solitaire™ Stent-retriever Thrombectomy in Acute Anterior Circulation Stroke: Methodology of a randomized, controlled, multicentre study. Int J Stroke. 2022 Jul;17(6):698-705. doi: 10.1177/17474930211048768. Epub 2021 Oct 14.

lead_sponsor: University Hospital Inselspital, Berne

location_country:
Spain
United Kingdom
Austria
Finland
Canada
Switzerland
France
Germany

location_facility: Dept. of Neurology, Ospedale Civo of Lugano

location_facility: Universitätsmedizin Mannheim, Universität Heidelber

location_facility: Medizinische Fakultät der Otto-von-Guericke-Universität Magdeburg

location_facility: St George's University Hospitals NHS Foundation Trust

location_facility: Dept. of Neuroradiology, UniversitätsSpital Zürich

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Dept. of Neurology, Centre hospitalier universitaire vaudois (CHUV)

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Royal University Hospital, University of Saskatchewan

location_facility: University of Calgary, Alberta Health Services

location_facility: Dept. of Neurology, Bern University Hospital

location_facility: Fondation Ophtalmologique A. de Rothschild

location_facility: Universitätsklinikum Knappschaftskrankenhaus GmbH Bochum

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: GHU Paris Psychiatrie et Neurosciences, Sainte Anne


acronym: BERGAMOT

title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Etrolizumab as an Induction And Maintenance Treatment For Patients With Moderately to Severely Active Crohn's Disease

lead_sponsor: Hoffmann-La Roche

ReferenceCitation: Sandborn WJ, Panés J, Danese S, Sharafali Z, Hassanali A, Jacob-Moffatt R, Eden C, Daperno M, Valentine JF, Laharie D, Baía C, Atreya R, Panaccione R, Rydzewska G, Aguilar H, Vermeire S; BERGAMOT Study Group. Etrolizumab as induction and maintenance therapy in patients with moderately to severely active Crohn's disease (BERGAMOT): a randomised, placebo-controlled, double-blind, phase 3 trial. Lancet Gastroenterol Hepatol. 2022 Oct 11. pii: S2468-1253(22)00303-X. doi: 10.1016/S2468-1253(22)00303-X. [Epub ahead of print]

ReferenceCitation: Dai B, Hackney JA, Ichikawa R, Nguyen A, Elstrott J, Orozco LD, Sun KH, Modrusan Z, Gogineni A, Scherl A, Gubatan J, Habtezion A, Deswal M, Somsouk M, Faubion WA, Chai A, Sharafali Z, Hassanali A, Oh YS, Tole S, McBride J, Keir ME, Yi T. Dual targeting of lymphocyte homing and retention through α4β7 and αEβ7 inhibition in inflammatory bowel disease. Cell Rep Med. 2021 Aug 17;2(8):100381. doi: 10.1016/j.xcrm.2021.100381. eCollection 2021 Aug 17.

ReferenceCitation: Reinisch W, Mishkin DS, Oh YS, Schreiber S, Hussain F, Jacob R, Hassanali A, Daperno M. Impact of various central endoscopy reading models on treatment outcome in Crohn's disease using data from the randomized, controlled, exploratory cohort arm of the BERGAMOT trial. Gastrointest Endosc. 2021 Jan;93(1):174-182.e2. doi: 10.1016/j.gie.2020.05.020. Epub 2020 May 25.

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
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Mexico
Slovakia
Brazil
Canada
Switzerland
Hungary
Germany
Bulgaria
Latvia
Estonia
New Zealand
Korea, Republic of
France
Netherlands

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: Queen Elizabeth II Health Sciences Centre; Gastroenterology Research

location_facility: Southwest Gastroenterology; DM Clinical Research

location_facility: Acibadem Kozyatagi Hospital; Gastroenterology

location_facility: CI of Healthcare Kharkiv Reg Clin Hosp-Center of Med Emergency & Accident Medicine

location_facility: The University of Chicago Medical Center

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

location_facility: Private Small Enterprise Medical Center Pulse

location_facility: Irkutsk State Medical Academy of Continuing Education

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

location_facility: Nottingham University Hospitals Queen's Medical Centre

location_facility: Clinical Hospital Center Sestre Milosrdnice

location_facility: Railway Transport Odesa CH of Healthcare Ctr Branch of PJSC Ukrainian Railway Dept of Therapy #2

location_facility: Medeniyet University Goztepe Training and Research Hospital; Chest Diseases

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza

location_facility: Digestive Disease Institute; Virginia Mason Medical Center

location_facility: University Hospital - London Health Sciences Centre

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

location_facility: University Hospital Medical Center Bezanijska kosa

location_facility: University of Texas Southwestern Medical Center; Internal Medicne

location_facility: SBEI HPE Altai StateMedicalUniversityofMoH andSD

location_facility: Zuyderland Medisch Centrum - Sittard Geleen

location_facility: Kyiv CCH #18 Dept of Proctology O. O. Bogomolets NMU

location_facility: McGuire Research Institute; Gastroenterology

location_facility: Texas Digestive Disease Consultants - Dallas

location_facility: Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A

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

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

location_facility: Haydarpasa Numune Training and Research Hospital; Medical Oncology

location_facility: Texas Digestive Disease Consultants - Southlake

location_facility: Gastroenterology Associates of Central Georgia

location_facility: Hospital Universitario Clementino Fraga Filho - UFRJ; Gastroenterologia

location_facility: Digestive Care Associates, A Medical Corporation

location_facility: SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego

location_facility: University of California San Diego Medical Center

location_facility: University of North Carolina At Chapel Hill

location_facility: Charlotte Gastroenterology and Hepatology, P.L.L.C

location_facility: Medical Center of Limited Liability Company Medical Clinic Blagomed

location_facility: Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH

location_facility: CHA Bundang Medical Centre; CHA university

location_facility: Elblaski Szpital Specjalistyczny z Przychodnia SP ZOZ

location_facility: BHI of Omsk region Clinical Oncology Dispensary

location_facility: EuroMediCare Szpital Specjalistyczny z Przychodnią we Wrocławiu

location_facility: Royal Wolverhampton hospital; McHale Building

location_facility: CI of Kyiv RC Regional Clinical Hospital #2

location_facility: Great Lakes Gastroenterology Research, LLC

location_facility: Kremenchuk first city hospital n.a. O.T. Bohaievskyi; Gastroenterology department

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej SONOMED

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Baylor College of Medicine; Gastroenterology

location_facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda

location_facility: Klinikum Mannheim GmbH Universitätsklinikum

location_facility: University of California at San Francisco (PARENT); Gastroenterology, Hepatology & Nutrition

location_facility: Northwestern University-Feinberg School of Medicine; Division of Gastroenterology and Hepatology

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska

location_facility: Riga East Clinical University Hospital; Clinic Gailezers

location_facility: Gastroenterology Associates of Western Michigan, P.L.C.

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital São Vicente de Paulo; Institute of Education and Reseach / Cardiovascular Research Unit

location_facility: University of Florida College of Medicine

location_facility: Asst Fatebenefratelli Sacco (Fatebenefratelli)

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

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Zespó Przychodni Specjalistycznych PRIMA

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

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Kocaeli Universitesi Tip Fakultesi; Infectious Diseases

location_facility: Hacettepe University Medical Faculty; Gastroenterology

location_facility: CHI Prof.O.O.Shalimov Kharkiv City Clinical Hospital #2

location_facility: Charite-Campus Virchow Klinikum; Hepatologie und Gastroenterologie

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

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

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Gastroenterology Center of the MidSouth PC

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

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: North-Western Medical University n.a. I.I. Mechnikov; Rheumatology

location_facility: Wolfson Medical Center; Obstetrics and Gynecology

location_facility: Medizinische Hochschule Hannover; Gastroenterology and Hepatology dept

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital Clínic i Provincial; Servicio de Farmacia

location_facility: Innovative Medical Research of South Florida

location_facility: Tel Aviv Sourasky Medical Center; Pharmacy

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

location_facility: The Ottawa Hospital - Riverside Campus; Gastrointestinal Clinical Research Unit

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

location_facility: Hospital do Servidor Público Estadual/HSPE-SP

location_facility: SBEIHPE Novosibirsk State Medical University

location_facility: Policlinico Universitario Agostino Gemelli; Farmacia

location_facility: L2IP -Instituto de Pesquisas Clínicas Ltda.

location_facility: Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj

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

location_facility: Federal State Military Educational Institution; High Professional Education Military Medical Acad

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

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

location_facility: Peak Gastroenterology Associates; Gastroenterology

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: Hospital Universitario Puerta de Hierro Majadahonda; Hepatology studies

location_facility: McGill University Health Centre - Glen Site

location_facility: Gastrointestinal Specialists of Georgia, PC

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

location_facility: University of Mississippi Medical Center; Division of Gastroenterology

location_facility: Royal Devon and Exeter Hospital (Wonford)

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

summary:
This is a multicenter, Phase 3, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of etrolizumab compared with placebo during induction and maintenance treatment of moderately to severely active Crohn's Disease (CD). The target population includes participants with CD who are refractory or intolerant to corticosteroids (CS) and/or immunosuppressant (IS) therapy and who have either not received prior anti-tumor necrosis factor (anti-TNF) therapy (TNF-naive) or who have had prior exposure to anti-TNF therapies and demonstrated inadequate responses or intolerance to anti-TNFs.

The study period will consist of a Screening Phase (up to 35 days) plus (+) a 14-week Induction Phase + a 52-week Maintenance Phase + a 12-week Safety Follow-up Phase. At Week 14 (end of Induction Phase), participants achieving a decrease from baseline of at least 70 points in the Crohn's Disease Activity Index (CDAI) score (CDAI-70 response) without the use of rescue therapy will continue to the Maintenance Phase.


title: Randomized, Multicenter, Phase II/III Study, Evaluating Fractionated Cisplatin Chemotherapy/Gemcitabine Versus Carboplatin/Gemcitabine in the Treatment of Advanced or Metastatic Urothelial Cancer With Impaired Renal Function.

acronym: VEFORA

summary:
This is a phase II/III, multicenter, randomized study which includes 420 patients on six years + 3 years follow up. 92 patients will be included during the phase II ; additional 328 patients will be included.

Patients with an advanced or metastatic urothelial cancer with impaired renal function will be randomized in one of the two following chemotherapy arm:

Fractionated Cisplatin + Gemcitabine.
Carboplatin + Gemcitabine.

The main objective of the part II study will be to evaluate the efficacy and the safety of a chemotherapy with a doublet platinum salt compound/Gemcitabine with fractionated Cisplatin or Carboplatin in this population.

The main objective of the part III study will be to compare the efficacy in terms of overall survival of a chemotherapy with a doublet platinum salt/Gemcitabine with fractionated Cisplatin or Carboplatin in this population.

lead_sponsor: Institut Claudius Regaud

location_facility: Institut de Cancerologie Lucien Neuwirth

location_facility: INSTITUT DE CANCEROLOGIE DE L'OUEST - Site René Gauducheau

location_facility: INSTITUT DE CANCEROLOGIE DE L'OUEST - Site Paul Papin


title: Evaluation of the Efficacy and Safety of an Infant Formula Containing Synbiotics and Its Effects on the Incidence of Infectious Diseases in the Infant Gut : a Double-blind, Randomized, Controlled Interventional Study

acronym: GOLFIII

summary: The primary objective of this study is to demonstrate that a synbiotic formula, fed for the duration of the first year of life (infant and follow-on formula) reduces the incidence rate of episodes of infectious diarrhea in infants during the first year of life compared to a standard infant formula.

lead_sponsor: HiPP GmbH & Co. Vertrieb KG

location_facility: C.I.C pédiatrique - C.H.U. de Nantes - Hôpital Mère-Enfant

location_facility: C.I.C Pédiatrique - C.H.U. de Grenoble - Hôpital Couple-Enfant

intervention_type: Dietary Supplement


acronym: MS-ON

title: Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis: a Pivotal Randomized Double Masked Placebo Controlled Study

lead_sponsor: MedDay Pharmaceuticals SA

ReferenceCitation: Tourbah A, Gout O, Vighetto A, Deburghgraeve V, Pelletier J, Papeix C, Lebrun-Frenay C, Labauge P, Brassat D, Toosy A, Laplaud DA, Outteryck O, Moreau T, Debouverie M, Clavelou P, Heinzlef O, De Sèze J, Defer G, Sedel F, Arndt C. MD1003 (High-Dose Pharmaceutical-Grade Biotin) for the Treatment of Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis: A Randomized, Double-Blind, Placebo-Controlled Study. CNS Drugs. 2018 Jul;32(7):661-672. doi: 10.1007/s40263-018-0528-2.

location_country:
France
United Kingdom

location_facility: Centre hospitalier national d'ophtalmologie des Quinze Vingts

location_facility: Centre hospitalier Intercommunal Poissy/Saint-Germain-en-Laye

summary: The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the visual improvement of patients suffering from chronic visual loss resulting from multiple sclerosis related optic neuritis.


title: A Randomized Phase III Study of Decitabine (DAC) With or Without Hydroxyurea (HY) Versus HY in Patients With Advanced Proliferative Chronic Myelomonocytic Leukemia (CMML)

acronym: GFM-DAC-CMML

summary:
This is a phase III, two-arm, randomized, stratified, multicenter, open-label study with individual therapeutic benefit aim:

Decitabine (DAC) with or without Hydroxyurea (HY) versus HY in patients with advanced proliferative Chronic Myelomonocytic Leukemia (CMML)

The primary objective of the study is to compare between the two arms Event-free Survival (EFS).

Secondary objectives are to compare between both arms:

Overall Survival (OS) Cumulative incidence of AML Overall and Complete Response Rates at 3 and 6 cycles according to IWG 2006 criteria modified for CMML Response duration Toxicity (hematological and non hematological) Prognostic factors

ReferenceCitation: Pleyer L, Leisch M, Kourakli A, Padron E, Maciejewski JP, Xicoy Cirici B, Kaivers J, Ungerstedt J, Heibl S, Patiou P, Hunter AM, Mora E, Geissler K, Dimou M, Jimenez Lorenzo MJ, Melchardt T, Egle A, Viniou AN, Patel BJ, Arnan M, Valent P, Roubakis C, Bernal Del Castillo T, Galanopoulos A, Calabuig Muñoz M, Bonadies N, Medina de Almeida A, Cermak J, Jerez A, Montoro MJ, Cortés A, Avendaño Pita A, Lopez Andrade B, Hellstroem-Lindberg E, Germing U, Sekeres MA, List AF, Symeonidis A, Sanz GF, Larcher-Senn J, Greil R. Outcomes of patients with chronic myelomonocytic leukaemia treated with non-curative therapies: a retrospective cohort study. Lancet Haematol. 2021 Feb;8(2):e135-e148. doi: 10.1016/S2352-3026(20)30374-4.

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility: IUCT Oncopole - Département d'hématologie


acronym: ECULISHU

title: Early Treatment With the Monoclonal C5 Antibody Eculizumab in Pediatric Patients Affected by Shiga-toxin Related Hemolytic and Uremic Syndrome: A Phase III Prospective Randomized Controlled Therapeutic Trial Versus Placebo

lead_sponsor: University Hospital, Toulouse

type: Other Grant/Funding Number

ReferenceCitation: Groussolles M, Winer N, Sentilhes L, Biquart F, Massoud M, Vivanti AJ, Bouchghoul H, Rozenberg P, Olivier P, Desbriere R, Chauleur C, Perrotin F, Coatleven F, Fuchs F, Bretelle F, Tsatsaris V, Salomon LJ, Sananes N, Kayem G, Houflin-Debarge V, Schmitz T, Benoist G, Arnaud C, Ehlinger V, Vayssière C; Groupe de Recherche en Gynecologie Obstétrique. Arabin pessary to prevent adverse perinatal outcomes in twin pregnancies with a short cervix: a multicenter randomized controlled trial (PESSARONE). Am J Obstet Gynecol. 2022 Aug;227(2):271.e1-271.e13. doi: 10.1016/j.ajog.2022.01.038. Epub 2022 Feb 3.

ReferenceCitation: Imdad A, Mackoff SP, Urciuoli DM, Syed T, Tanner-Smith EE, Huang D, Gomez-Duarte OG. Interventions for preventing diarrhoea-associated haemolytic uraemic syndrome. Cochrane Database Syst Rev. 2021 Jul 5;7:CD012997. doi: 10.1002/14651858.CD012997.pub2.

ReferenceCitation: Matrat L, Bacchetta J, Ranchin B, Tanné C, Sellier-Leclerc AL. Pediatric atypical hemolytic-uremic syndrome due to auto-antibodies against factor H: is there an interest to combine eculizumab and mycophenolate mofetil? Pediatr Nephrol. 2021 Jun;36(6):1647-1650. doi: 10.1007/s00467-021-05025-8. Epub 2021 Mar 28.

ReferenceCitation: Muff-Luett M, Sanderson KR, Engen RM, Zahr RS, Wenderfer SE, Tran CL, Sharma S, Cai Y, Ingraham S, Winnicki E, Weaver DJ, Hunley TE, Kiessling SG, Seamon M, Woroniecki R, Miyashita Y, Xiao N, Omoloja AA, Kizilbash SJ, Mansuri A, Kallash M, Yu Y, Sherman AK, Srivastava T, Nester CM. Eculizumab exposure in children and young adults: indications, practice patterns, and outcomes-a Pediatric Nephrology Research Consortium study. Pediatr Nephrol. 2021 Aug;36(8):2349-2360. doi: 10.1007/s00467-021-04965-5. Epub 2021 Mar 10.

location_facility:
Robert Debré Hospital
Anne de Bretagne University Hospital
Purpan Children Hospital
Necker Hospital
University Hospital
Clocheville Hospital
La Timone Hospital
Pellegrin Hospital
Jeanne de Flandre Hospital
Mother and Child Hospital
Morvan Hospital
Trousseau Hospital
Women, Mother and Child Hospital

summary:
The investigators aim to perform the first controlled randomized prospective study using ECZ in pediatric STEC-HUS. This is of great interest as there is still no efficient specific therapy in that potentially devastating disease.

Furthermore, published data concerning the use of ECZ in STEC-HUS are controversial, reflecting statistical bias in retrospective or uncontrolled studies, thus emphasizing the need for prospective studies.


acronym: JUNIPER

title: An Open-Label Extension and Safety Monitoring Study of Patients With Moderately to Severely Active Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Protocol GA29144

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: Queen Elizabeth II Health Sciences Centre; Gastroenterology Research

location_facility: University of North Carolina at Chapel Hill

location_facility: Acibadem Kozyatagi Hospital; Gastroenterology

location_facility: CI of Healthcare Kharkiv Reg Clin Hosp-Center of Med Emergency & Accident Medicine

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

location_facility: Private Small Enterprise Medical Center Pulse

location_facility: Irkutsk State Medical Academy of Continuing Education

location_facility: Nottingham University Hospitals Queen's Medical Centre

location_facility: Clinical Hospital Center Sestre Milosrdnice

location_facility: Railway Transport Odesa CH of Healthcare Ctr Branch of PJSC Ukrainian Railway Dept of Therapy #2

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza

location_facility: Universidade Federal de Sao Paulo - UNIFES

location_facility: Digestive Disease Institute; Virginia Mason Medical Center

location_facility: University Hospital - London Health Sciences Centre

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

location_facility: University of Texas Southwestern Medical Center; Internal Medicne

location_facility: Szt Janos Korhaz es EbudaiEgyesitettKorhazak

location_facility: Vidant Medical Group, LLC DBA Vidant Multispeciality Clinic-Kinston

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Amsterdam UMC, Locatie VUMC; Gastroenterology

location_facility: Medeniyet University Goztepe Training and Research Hospital.

location_facility: SBEI HPE Altai StateMedicalUniversityofMoH andSD

location_facility: Riga East Clinical University Hospital, clinic "Gailezers"; Department of Endoscopy

location_facility: Zuyderland Medisch Centrum - Sittard Geleen

location_facility: McGuire Research Institute; Gastroenterology

location_facility: Texas Digestive Disease Consultants - Dallas

location_facility: Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A

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

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

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

location_facility: ULB Hopital Erasme; Service de Néphrologie

location_facility: Texas Digestive Disease Consultants - Southlake

location_facility: Gastroenterology Associates of Central Georgia

location_facility: Digestive Care Associates, A Medical Corporation

location_facility: Weill Cornell Medical College-New York Presbyterian Hospital

location_facility: SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego

location_facility: University of California San Diego Medical Center

location_facility: Medical Center of Limited Liability Company Medical Clinic Blagomed

location_facility: Charlotte Gastroenterology and Hepatology, P.L.L.C

location_facility: Uni. of California at San Francisco; Dept Pediatric, Div. of Gastroenterology, Hepatology & Nutri

location_facility: Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH

location_facility: CHA Bundang Medical Centre; CHA university

location_facility: Elblaski Szpital Specjalistyczny z Przychodnia SP ZOZ

location_facility: BHI of Omsk region Clinical Oncology Dispensary

location_facility: CI of Kyiv RC Regional Clinical Hospital #2

location_facility: Great Lakes Gastroenterology Research, LLC

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej SONOMED

location_facility: Hospital de Base de Sao Jose do Rio Preto

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: Federal State Military Educational Inst. of High Prof. Edu Military Medical Acad; Therapy department

location_facility: RCI Chernivtsi RCH Dep of Surgery Bukovinian SMU

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska

location_facility: SBEIHPE Novosibirsk State Medical University

location_facility: Gastroenterology Associates of Western Michigan, P.L.C.

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

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

location_facility: Vilnius University Hospital Santariskiu Clinics, Public Inst; Department of Clinical Pharmacology

location_facility: University of Florida College of Medicine

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

location_facility: Asst Fatebenefratelli Sacco (Fatebenefratelli)

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Zespó Przychodni Specjalistycznych PRIMA

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

location_facility: Kocaeli Universitesi Tip Fakultesi; Infectious Diseases

location_facility: Hacettepe University Medical Faculty; Gastroenterology

location_facility: Leids Universitair Medisch Centrum; Cardiology

location_facility: University of Mississippi Medical Center

location_facility: Winnipeg Regional Health Authority; Neurosurgery Department

location_facility: Charite-Campus Virchow Klinikum; Hepatologie und Gastroenterologie

location_facility: Haydarpasa Numune Training and Research Hospital; Gastroenterology

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

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Northwestern Uni-Feinberg School of Medicine

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: North-Western Medical University n.a. I.I. Mechnikov; Rheumatology

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital Clínic i Provincial; Servicio de Farmacia

location_facility: Innovative Medical Research of South Florida

location_facility: Tel Aviv Sourasky Medical Center; Pharmacy

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

location_facility: Debreceni Egyetem Klinikai Központ; Bőrgyógyászati Klinika

location_facility: The Ottawa Hospital - Riverside Campus; Gastrointestinal Clinical Research Unit

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

location_facility: Hospital do Servidor Público Estadual/HSPE-SP

location_facility: Policlinico Universitario Agostino Gemelli; Farmacia

location_facility: Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj

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

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: Charité Campus Virchow-Klinikum; Department of Cardiology

location_facility: LEC at SBIH of Moscow "City Clinical Hospital # 24"; Gastroenterology

location_facility: Hospital Universitario Clementino Fraga Filho - UFRJ

summary: This open-label extension and safety monitoring study is composed of two parts: Part 1 will evaluate the long-term safety and efficacy of continued etrolizumab treatment in participants with moderately to severely active Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144 (NCT02394028) and who meet eligibility criteria for enrollment into Part 1. In Part 2, participants who have stopped etrolizumab treatment (either by exiting Part 1 of this study or by entering directly from Study GA29144 [NCT02394028]) will be monitored for 92 weeks for progressive multifocal leukoencephalopathy (PML) and other safety events.