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. No abstract available.

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. No abstract available.

ReferenceCitation: Brohi K, Singh J, Heron M, Coats T. Acute traumatic coagulopathy. J Trauma. 2003 Jun;54(6):1127-30. doi: 10.1097/01.TA.0000069184.82147.06.

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. No abstract available.

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. 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.

ReferenceType: result

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, Negrier 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. doi: 10.1097/TA.0b013e3181271ba3.

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.

version: acceptedVersion

publisher_dissemination: Wolters Kluwer Health

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.

publisher_dissemination: American Medical Association

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. doi: 10.1111/j.1538-7836.2007.02319.x. Epub 2006 Nov 16.

ReferenceCitation: Jost D, Lemoine S, Lemoine F, Derkenne C, Beaume S, Lanoe V, Maurin O, Louis-Delauriere E, Delacote M, Dang-Minh P, Franchin-Frattini M, Bihannic R, Savary D, Levrat A, Baudouin C, Trichereau J, Salome 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.

license: cc-by

license_normalized: cc-by

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENS-LYON

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

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, Salome 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.

collaborators: Bataillon des marins pompiers de Marseille, France

collaborators: Military Hospital Laveran,Marseille, France

collaborators: Fire Brigade Of Paris Emergency Medicine Dept

collaborators: Institut de Recherche Biomedicale des Armees

collaborators: Military Hospital Percy , Clamart, France

collaborators: Military Hospital Begin, Saint-Mandé, France

collaborators: Centre de transfusion sanguine des Armées, Clamart, France

collaborators: Samu of Beaujon, Clichy-La-Garenne, France

location_facility: Hopital d'Instruction des Armées LAVERAN

location_facility: Centre de Transfusion Sanguine des Armées

location_facility: Bataillon des marins-pompiers de Marseille

location_facility: Hopital des Instructions des Armées BEGIN


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: Institut de Recherches Internationales Servier

summary: The purpose of this study was to evaluate the efficacy and the safety of bumetanide/S95008 in the improvement of Autism Spectrum Disorder core symptoms.

location_facility: Centro Hospitalar e Universitario de Coimbra Hospital Pediatrico

location_facility: Universidade Federal de São Paulo, Escola Paulista de Medicina

location_facility: Hospital Universitário Walter Cantídio - Universidade Federal do Ceará

location_facility: Centre Hospitalier du Rouvray Centre de Ressources pour l'Autisme

location_facility: Hôpital Robert Debré Service de Psychiatrie de l'enfant et de l'adolescent

location_facility: Centre Hospitalier Charles Perrens CRA Aquitaine

location_facility: Forward Thinking Birmingham_Birmingham Women's and Children's NHS Foundation Trust

location_facility: Klinik für Psychiatrie und Psychotherapie des Kindes- und Jugendalters am Zentralinstitut für Seelische Gesundheit

location_facility: Trial Tech em Pesquisas com Medicamentos Ltda

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden, Klinik und Poliklinik für Kinder- und Jugendpsychiatrie und

location_facility: Neuro Riabilitazione/Psicopatologia dell'età evolutiva Istituto Scientifico Medea - Bosisio Parini

location_facility: U.O. di Neuropsichiatria Infantile Azienda Ospedaliera Universitaria Senese

location_facility: Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza Ospedale Pediatrico-Microcitemico

location_facility: Szegedi Tudományegyetem Szent-Gyorgy Albert Klinikai Kozpont Gyermekgyógyászati Klinika Gyermek es Ifjusagpszichiátriai o

location_facility: U.O.C. Psichiatria dello Sviluppo IRCCS Fondazione Stella Maris

location_facility: Universitätsklinikum Freiburg, Zentrum für Psychische Erkrankungen, Klinik für Psychiatrie, Psychotherapie und Psychosomatik im Kindes- und Jugendalter

location_facility: Hôpitaux Universitaires de Strasbourg Service de Psychiatrie de l'Enfant et de l'Adolescent

location_facility: Hospital General Universitario de Alicante

location_facility: Programma Interdipartimentale "Autismo 0-90" A.O.U. Policlinico "Gaetano Martino"

location_facility: Centrum Badań Klinicznych PI-House sp. z o.o

location_facility: Hôpital Le Vinatier CRA Rhône-Alpes, Bat 211

location_facility: Bekes Megyei Kozponti Korhaz Gyermek es ifjusagpszichiatriai osztaly

location_facility: NAVICULA Centrum Diagnozy i Terapii Autyzmu w Łodzi

location_facility: Unità Semplice di Psichiatria Infantile Policlinico Universitario di Napoli - Università Federico II

location_facility: Faculdade de Medicina da Universidade de São Paulo - Departamento de Psiquiatria

location_facility: U.O. di Neuropsichiatria Infantile Fondazione Istituto Neurologico Nazionale Casimiro Mondino Istituto di Ricovero e Cura a Carattere Scientifico

location_facility: Niepubliczny Zakład Opieki Zdrowotnej Gdańskie Centrum Zdrowia Sp. z o.o.

location_facility: Samodzielny Publiczny Dziecięcy Szpital Kliniczny w Warszawie Oddział Kliniczny Psychiatrii Wieku Rozwojowego

status: Terminated

title: A 6-month Randomised, Double-blind, Placebo Controlled Multicentre Parallel Group Study to Evaluate Efficacy and Safety of Bumetanide 0.5mg Twice a Day Followed by an Open Label Active 6-month Treatment Period With Bumetanide (0.5mg Twice a Day) and a 6 Weeks Discontinuation Period After Treatment Stop.

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Germany
Italy
Poland
Portugal
Hungary
United Kingdom
Brazil
Netherlands
Spain
France

study_type: Interventional

ipd_sharing: Yes

lead_sponsor_type: industriel

status_simplified: Unknown


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.

status: Completed

ReferenceType: background

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.

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license_normalized: no license

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

host_type: repository

repository_institution: Queen's University Belfast - Research Portal

unpaywall_oa_status: bronze

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.

ReferenceCitation: Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2014 Mar 6;370(10):980. doi: 10.1056/NEJMc1400293. No abstract available.

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. doi: 10.1001/jama.282.1.54.

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, Guerin 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: Guerin 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.

oa_host_type: publisher

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publisher_dissemination: Massachusetts Medical Society

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

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. doi: 10.1007/s001340051196.

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. doi: 10.1097/00000542-200204000-00004.

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: Guldner 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.

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.

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.

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.

ReferenceType: derived

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 Gonzalez A, 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.

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

repository_institution: University of Ferrara - Institutional Research Information System University of Ferrara

repository_institution: Nova Science Publishers, Inc. - Nova Science Publishers

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unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

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.

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: PubMed Central - Europe PMC

repository_institution: University of Milano-Bicocca - BOA - Bicocca Open Archive

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

lead_sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

collaborators: European Society of Intensive Care Medicine

location_country:
Germany
Italy
United Kingdom
China
Spain
Greece
France

location_facility: UNIVERSITÄTSKLINIKUM Schleswig-Holstein Campus Kiel

location_facility: Barking, Havering and Redbridge Hospital


title: APEX-AMI - Pexelizumab in Conjunction With Angioplasty

summary: In the setting of reperfusion therapy in an acute myocardial infarction using primary percutaneous intervention (PCI), the body's own inflammatory system involving the complement cascade may be harmful. This study will test the safety and efficacy of a novel complement inhibitor, pexelizumab to reduce mortality at 30 days.

ReferenceCitation: Bagai A, Armstrong PW, Stebbins A, Mahaffey KW, Hochman JS, Weaver WD, Patel MR, Granger CB, Lopes RD. Prognostic implications of left ventricular end-diastolic pressure during primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: Findings from the Assessment of Pexelizumab in Acute Myocardial Infarction study. Am Heart J. 2013 Nov;166(5):913-9. doi: 10.1016/j.ahj.2013.08.006. Epub 2013 Sep 24.

oa_host_type: closed

ReferenceCitation: Guptill JT, Mehta RH, Armstrong PW, Horton J, Laskowitz D, James S, Granger CB, Lopes RD. Stroke after primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction: timing, characteristics, and clinical outcomes. Circ Cardiovasc Interv. 2013 Apr;6(2):176-83. doi: 10.1161/CIRCINTERVENTIONS.112.000159. Epub 2013 Apr 2.

ReferenceCitation: Westerhout CM, Pieper KS, James SK, Mahaffey KW, de Werf FV, Califf RM, Granger CB, Armstrong PW. Dynamic modeling of 90-day mortality in ST-elevation myocardial infarction patients undergoing primary percutaneous coronary intervention. Am Heart J. 2013 Mar;165(3):354-62.e2. doi: 10.1016/j.ahj.2012.12.001. Epub 2013 Jan 15.

ReferenceCitation: Patel MR, Westerhout CM, Granger CB, Brener SJ, Fu Y, Siha H, Kim RJ, Armstrong PW. Aborted myocardial infarction after primary percutaneous coronary intervention: magnetic resonance imaging insights from the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial. Am Heart J. 2013 Feb;165(2):226-33. doi: 10.1016/j.ahj.2012.10.028. Epub 2012 Nov 24.

ReferenceCitation: Truffa AA, Granger CB, White KR, Newby LK, Mehta RH, Hochman JS, Patel MR, Pieper KS, Al-Khalidi HR, Armstrong PW, Lopes RD. Serious infection after acute myocardial infarction: incidence, clinical features, and outcomes. JACC Cardiovasc Interv. 2012 Jul;5(7):769-76. doi: 10.1016/j.jcin.2012.03.018.

ReferenceCitation: Martel C, Granger CB, Ghitescu M, Stebbins A, Fortier A, Armstrong PW, Bonnefoy A, Theroux P. Pexelizumab fails to inhibit assembly of the terminal complement complex in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention. Insight from a substudy of the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial. Am Heart J. 2012 Jul;164(1):43-51. doi: 10.1016/j.ahj.2012.04.007. Epub 2012 Jun 15.

ReferenceCitation: van Diepen S, Widimsky P, Lopes RD, White KR, Weaver WD, Van de Werf F, Ardissino D, van't Hof AW, Armstrong PW, Granger CB. Transfer times and outcomes in patients with ST-segment-elevation myocardial infarction undergoing interhospital transfer for primary percutaneous coronary intervention: APEX-AMI insights. Circ Cardiovasc Qual Outcomes. 2012 Jul 1;5(4):437-44. doi: 10.1161/CIRCOUTCOMES.112.965160. Epub 2012 May 15.

ReferenceCitation: Hudson MP, Armstrong PW, O'Neil WW, Stebbins AL, Weaver WD, Widimsky P, Aylward PE, Ruzyllo W, Holmes D, Mahaffey KW, Granger CB. Mortality implications of primary percutaneous coronary intervention treatment delays: insights from the Assessment of Pexelizumab in Acute Myocardial Infarction trial. Circ Cardiovasc Qual Outcomes. 2011 Mar;4(2):183-92. doi: 10.1161/CIRCOUTCOMES.110.945311. Epub 2011 Feb 8.

ReferenceCitation: Huber K, Holmes DR Jr, van 't Hof AW, Montalescot G, Aylward PE, Betriu GA, Widimsky P, Westerhout CM, Granger CB, Armstrong PW. Use of glycoprotein IIb/IIIa inhibitors in primary percutaneous coronary intervention: insights from the APEX-AMI trial. Eur Heart J. 2010 Jul;31(14):1708-16. doi: 10.1093/eurheartj/ehq143. Epub 2010 May 25.

ReferenceCitation: Alhadramy O, Westerhout CM, Brener SJ, Granger CB, Armstrong PW; APEX AMI Investigators. Is visual interpretation of coronary epicardial flow reliable in patients with ST-elevation myocardial infarction undergoing primary angioplasty? Insights from the angiographic substudy of the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial. Am Heart J. 2010 May;159(5):899-904. doi: 10.1016/j.ahj.2010.02.028.

ReferenceCitation: Patel MR, Worthley SG, Stebbins A, Dill T, Rademakers FE, Valeti US, Barsness GW, Van de Werf F, Hamm CW, Armstrong PW, Granger CB, Kim RJ. Pexelizumab and infarct size in patients with acute myocardial infarction undergoing primary percutaneous coronary Intervention: a delayed enhancement cardiac magnetic resonance substudy from the APEX-AMI trial. JACC Cardiovasc Imaging. 2010 Jan;3(1):52-60. doi: 10.1016/j.jcmg.2009.09.014. Epub 2010 Jan 12. Erratum In: JACC Cardiovasc Imaging. 2010 Jul;3(7):796. Velleti, Uma S [corrected to Valeti, Uma S].

ReferenceCitation: Trendelenburg M, Theroux P, Stebbins A, Granger C, Armstrong P, Pfisterer M. Influence of functional deficiency of complement mannose-binding lectin on outcome of patients with acute ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention. Eur Heart J. 2010 May;31(10):1181-7. doi: 10.1093/eurheartj/ehp597. Epub 2010 Jan 19.

ReferenceCitation: Brener SJ, Westerhout CM, Fu Y, Todaro TG, Moliterno DJ, Wagner GS, Granger CB, Armstrong PW; APEX-AMI Investigators. Contribution of angiographic and electrocardiographic parameters of reperfusion to prediction of mortality and morbidity after acute ST-elevation myocardial infarction: Insights from the Assessment of Pexelizumab in Acute Myocardial Infarction trial. Am Heart J. 2009 Nov;158(5):755-60. doi: 10.1016/j.ahj.2009.09.009. Epub 2009 Oct 3.

ReferenceCitation: Armstrong PW, Fu Y, Westerhout CM, Hudson MP, Mahaffey KW, White HD, Todaro TG, Adams PX, Aylward PE, Granger CB. Baseline Q-wave surpasses time from symptom onset as a prognostic marker in ST-segment elevation myocardial infarction patients treated with primary percutaneous coronary intervention. J Am Coll Cardiol. 2009 Apr 28;53(17):1503-9. doi: 10.1016/j.jacc.2009.01.046.

ReferenceCitation: Buller CE, Fu Y, Mahaffey KW, Todaro TG, Adams P, Westerhout CM, White HD, van 't Hof AW, Van de Werf FJ, Wagner GS, Granger CB, Armstrong PW. ST-segment recovery and outcome after primary percutaneous coronary intervention for ST-elevation myocardial infarction: insights from the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial. Circulation. 2008 Sep 23;118(13):1335-46. doi: 10.1161/CIRCULATIONAHA.108.767772. Epub 2008 Sep 8.

ReferenceCitation: APEX AMI Investigators; Armstrong PW, Granger CB, Adams PX, Hamm C, Holmes D Jr, O'Neill WW, Todaro TG, Vahanian A, Van de Werf F. Pexelizumab for acute ST-elevation myocardial infarction in patients undergoing primary percutaneous coronary intervention: a randomized controlled trial. JAMA. 2007 Jan 3;297(1):43-51. doi: 10.1001/jama.297.1.43.

lead_sponsor: Procter and Gamble

location_country:
Germany
Italy
Poland
Portugal
New Zealand
Denmark
Australia
Sweden
Netherlands
Austria
Belgium
Switzerland
United States
Spain
Czechia
Canada
France

location_facility: I. Interni klinika, Fakultni nemocnice Hradec

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: MultiCare Medical Center (Tacoma General Hospital)

location_facility: Kardiologicke odd. Nemocnice Ceske Budejovice as

location_facility: II. Interni klinika, Vseobecna fakultni nemocnice

location_facility: Universitatsklinik der Ruhr-Universitat Bochum

location_facility: Saint John Regional Hospital - New Brunswick Heart Centre

location_facility: I. Interni klinika, Fakultni nemocnice Plzen

location_facility: Hopital d'adultes de Brabois (CHU de Nancy)

location_facility: Kardiologicke odd., Nemocnice Na Homoice

location_facility: Montreal Heart Institute/Research Centre

location_facility: Centre Hospitale de'Universite de Montreal (Pav Notre-Dame)_

location_facility: Health First Holmes Regional Medical Center

location_facility: Kardiocentrum, Fakultni nemocnice Kralovske Vinohrady

location_facility: Universitiy of Virginia Health Science Center

location_facility: South Texas Veterans Health Care System Audie L. Murphy Division

location_facility: A.O. della Regione Lombardia Presidio Ospedaliero Sant'Anna

location_facility: Ciutat Sanitaria i Universitaria de Bellvitge

location_facility: Kardiologicke oddeleni, Masarykova nemocnice

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: I. interni kardioangiologicka klinika, Fakultni nemocnice u Sv. Anny

location_facility: Hospital of the University of Pennsylvania

location_facility: Hospital Garcia de Orta - Servico de Cardiologia

location_facility: Azienda Ospedaliera di Parma - Ospedale Maggiore

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: University of Oklahoma Health Sciences Center

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Interni kardiologicka klinika, Fakultni nemocnice Brno

location_facility: Hospital Sao Joao - Servico de Cardiologia

location_facility: University of Missouri Health Sciences Center

location_facility: Kardiologicke odd., Krajska neocnice Liberec

location_facility: Sunnybrook & Women's Health Sciences Centre

location_facility: SPZOZ Dolnoslaski Szpital Specjalistyczny

location_facility: Kardio-Troll sro and Krajska nemocnice Pardubice

location_facility: A.O. SS. Antonio e Biagio e Cesare Arrigo

status_simplified: Completed


lead_sponsor: Novartis Pharmaceuticals

summary: This study will assess the efficacy and safety of nilotinib in adult patients with newly diagnosed Philadelphia chromosome positive/BCR-ABL positive chronic myeloid leukaemia in chronic phase. The aim of the study is to confirm the rates of complete molecular remission (CMR) of nilotinib in newly diagnosed CML chronic phase patients in a pan-European population using the EUTOS standardized laboratories.

ReferenceCitation: Gullaksen SE, Skavland J, Gavasso S, Tosevski V, Warzocha K, Dumrese C, Ferrant A, Gedde-Dahl T, Hellmann A, Janssen J, Labar B, Lang A, Majeed W, Mihaylov G, Stentoft J, Stenke L, Thaler J, Thielen N, Verhoef G, Voglova J, Ossenkoppele G, Hochhaus A, Hjorth-Hansen H, Mustjoki S, Sopper S, Giles F, Porkka K, Wolf D, Gjertsen BT. Single cell immune profiling by mass cytometry of newly diagnosed chronic phase chronic myeloid leukemia treated with nilotinib. Haematologica. 2017 Aug;102(8):1361-1367. doi: 10.3324/haematol.2017.167080. Epub 2017 May 18.

license: cc-by-nc

license_normalized: cc-by-nc

repositories_concat: PubMed Central;medlib.mef.hr

unpaywall_oa_status: gold

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Thielen N, Richter J, Baldauf M, Barbany G, Fioretos T, Giles F, Gjertsen BT, Hochhaus A, Schuurhuis GJ, Sopper S, Stenke L, Thunberg S, Wolf D, Ossenkoppele G, Porkka K, Janssen J, Mustjoki S. Leukemic Stem Cell Quantification in Newly Diagnosed Patients With Chronic Myeloid Leukemia Predicts Response to Nilotinib Therapy. Clin Cancer Res. 2016 Aug 15;22(16):4030-8. doi: 10.1158/1078-0432.CCR-15-2791. Epub 2016 Mar 22.

oa_host_type: repository

evidence: oa repository (via page says license)

version: submittedVersion

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

repository_institution: University of Illinois at Chicago - INDIGO

unpaywall_oa_status: green

publisher_dissemination: American Association for Cancer Research

title: A Phase IIIb, Multicentre, Open-label Study of Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome and/or BCR-ABL Positive CML in Chronic Phase

location_country:
Finland
Germany
Poland
Croatia
France
Czech Republic
Lithuania
Slovenia
Portugal
Slovakia
Hungary
Denmark
Switzerland
Latvia
Romania
Belgium
Estonia
Italy
Norway
United Kingdom
Netherlands
Austria
Spain
Greece
Bulgaria
Sweden


title: Long Term Follow-up of Twisted Fallopian Tubes Among Young Girl. International Study

acronym: Tubes

summary:
Isolated tubal torsion is a very rare event already in adults (1: 1.5 million women), it remains exceptional in children without being able to find a prevalence in the literature. The causes can be malformative or idiopathic, but even that remains unknown.

Because of the scarcity, surgical treatment is not standardized and left to the good care of the surgeon in charge.

study_start_date_type: Anticipated

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Retrospective

enrollment_type: Anticipated

lead_sponsor: Hospices Civils de Lyon

location_country: Italy Romania Lebanon Turkey France

location_facility: APHM, Hôpital La Timone Enfants et Hôpital Nord

location_facility: ASP Trapani - presidio ospedaliero "S. Antonio Abate

location_facility: Azienda Ospedaliera Universitaria di Padova

location_facility: Institute for Maternal and Child Health IRCCS G. Gaslini, Genova

location_facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo

location_facility: Ege University Faculty of Medicine Children's Hospital

location_facility: Centre Hospitalier Universitaire de Angers

intervention_type: Procedure

lead_sponsor_type: academique


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

acronym: CACTUS-PTS

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

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

license: publisher-specific-oa

license_normalized: publisher-specific

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

evidence: open (via crossref license, author manuscript)

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

lead_sponsor: University Hospital, Geneva

collaborators: Canadian Institutes of Health Research (CIHR)

location_country: Canada Switzerland France

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


title: Randomized Control Study : Evaluation of the Benefits of Glucose Drinks During Childbirth

acronym: SOLISO

summary:
Fear of full stomach when emergency general anaesthesia is required is the origin of fastening when giving birth. This behaviour does not warranty perfect security for the general anaesthesia. In addition, well being for women and new born is affected. Giving birth is finally compared to a sportive competition with high-energy needs. As Intravenous energy intake is not regulated by physiologic digestion, it can induce metabolic disorders for the mother that can be amplified for the foetus.

Oral glucose drinks could offer some benefits:

gastric acidity would be decreased without significant increase in volumes.
energy intake would further more active and more efficiency labour
an increase in foetus well being

However, it has never been shown yet that such behaviour could offer those benefits. Also, it seems that there is not more vomiting, but most of the studies compared oral glucose intake to waterborne intake with the same volumes The expected efficacy is a reduction in labour duration and a reduction in percentage of extraction. Previous studies said that the lack of statistical power due to small number of subjects caused the absence of statistical significant relationship.

In addition, even though newborn have less acidosis, there is no clinical relationship proven.

The investigators propose a randomised multicentre study to assess efficacy of oral glucose drinks in comparison to traditional fastening when giving birth.

Main objective is to significantly reduce instrumental extraction rates. 5400 women will be included in the study in 2 years.

lead_sponsor: University Hospital, Caen

location_facility: Centre Hospitalier Mémorial France Etats-Unis

intervention_type: Other


title: Solitaire™ With the Intention For Thrombectomy Plus Intravenous t-PA Versus DIRECT Solitaire™ Stent-retriever Thrombectomy in Acute Anterior Circulation Stroke

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, Ijas P, Preterre 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. 2023 Nov;15(e2):e232-e239. doi: 10.1136/jnis-2022-019585. Epub 2022 Nov 17.

evidence: open (via page says license)

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

publisher_dissemination: British Medical Journal

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, Raty 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. 2023 Sep;15(e1):e102-e110. doi: 10.1136/jnis-2022-019207. Epub 2022 Jul 28.

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

repository_institution: Georg-August-Universität Göttingen - GoeScholar  The Publication Server of the Georg-August-Universität Göttingen

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

repository_institution: University of Zurich - Zurich Open Repository and Archive

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

ReferenceCitation: Fischer U, Kaesmacher J, Strbian D, Eker O, Cognard C, Plattner PS, Butikofer 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, Hernandez-Perez 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, Butikofer 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.

publisher_dissemination: SAGE Publications

ipd_sharing: No

lead_sponsor: Insel Gruppe AG, University Hospital Bern

location_country:
Finland
Germany
United Kingdom
Switzerland
Austria
Spain
Canada
France

location_facility: GHU Paris Psychiatrie et Neurosciences, Sainte Anne

location_facility: Dept. of Neurology, Bern University Hospital

location_facility: Dept. of Neuroradiology, UniversitätsSpital Zürich

location_facility: Fondation Ophtalmologique A. de Rothschild

location_facility: St George's University Hospitals NHS Foundation Trust

location_facility: Royal University Hospital, University of Saskatchewan

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

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Universitätsmedizin Mannheim, Universität Heidelber

location_facility: Dept. of Neurology, Ospedale Civo of Lugano

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

location_facility: Universitätsklinikum Knappschaftskrankenhaus GmbH Bochum

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: University of Calgary, Alberta Health Services

location_facility: Klinikum rechts der Isar der Technischen Universität München

intervention_type: Device


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.

time_perspective: Prospective

lead_sponsor: Lille Catholic University

sponsor_collaborators:
Lille Catholic University
UNEOS

location_facility: Hôpital Neurologique Pierre Wertheimer - Hospices Civils de Lyon

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Hôpital Edouard Herriot - Hospices Civils de Lyon


title: Interest of the Smartphone Application "MonCœur" in the Follow-up of Patients With Heart Failure

acronym: APPLIMONCOEUR

summary: Heart failure is a chronic disease that requires careful monitoring and therapeutic education. Smartphones have made their appearance in patients lives and allow close contact with them. The possibility of using a digital application dedicated to patients with heart failure concerning the symptoms to be monitored, treatments, diet, appointments, physical activity could improve the monitoring and the prognosis of patients following their hospitalization.

primary_purpose: Supportive Care

lead_sponsor: French Cardiology Society

location_facility:
Hôpital Européen Georges Pompidou
Hôpital Universitaire Pitié Salpêtrière
CHU Arnaud de Villeneuve
Hôpital Sainte Musse de Toulon
CHU de Poitiers
CHU Amiens - Picardie - Site Sud
CHRU de Strasbourg
CHU de Toulouse
Hôpital Lariboisière
CHRU de Lille
CHU de Grenoble
Hospices Civils de Lyon
CHU Henri Mondor
Hôpital Bicêtre
Groupe Hospitalier Sud Ile de France
CHU de ROUEN - Hôpital Charles Nicolle


title: Efficacy of Captopril Nebulization in Covid-19 Patients Suffering of SARS CoV-2 Pneumonia. A Randomized Phase II Study

acronym: CAPTOCOVID

summary: Captopril being an effective drug available in liquid preparation, administration by nebulization could be of interest for maximizing lung action and minimizing systemic side effects. Such a treatment might be used for "Covid-19" patients with pneumonia in order to avoid ARDS.

ReferenceCitation: Gurwitz D. Angiotensin receptor blockers as tentative SARS-CoV-2 therapeutics. Drug Dev Res. 2020 Aug;81(5):537-540. doi: 10.1002/ddr.21656. Epub 2020 Mar 4.

ReferenceCitation: Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

license: unspecified-oa

license_normalized: unspecified-oa

repository_normalized: medRxiv

repositories:
PubMed Central
medRxiv

repositories_concat: PubMed Central;medRxiv

ReferenceCitation: Li F, Li W, Farzan M, Harrison SC. Structure of SARS coronavirus spike receptor-binding domain complexed with receptor. Science. 2005 Sep 16;309(5742):1864-8. doi: 10.1126/science.1116480.

ReferenceCitation: Imai Y, Kuba K, Rao S, Huan Y, Guo F, Guan B, Yang P, Sarao R, Wada T, Leong-Poi H, Crackower MA, Fukamizu A, Hui CC, Hein L, Uhlig S, Slutsky AS, Jiang C, Penninger JM. Angiotensin-converting enzyme 2 protects from severe acute lung failure. Nature. 2005 Jul 7;436(7047):112-6. doi: 10.1038/nature03712.

ReferenceCitation: Zhang H, Penninger JM, Li Y, Zhong N, Slutsky AS. Angiotensin-converting enzyme 2 (ACE2) as a SARS-CoV-2 receptor: molecular mechanisms and potential therapeutic target. Intensive Care Med. 2020 Apr;46(4):586-590. doi: 10.1007/s00134-020-05985-9. Epub 2020 Mar 3. No abstract available.

repositories_concat: PubMed Central;frl.publisso.de

publisher_dissemination: Springer-Nature

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
CHRU de Tours, Hôpital Bretonneau
Hôpital Avicenne
Hôpital Antoine Béclère
Hôpital Tenon
CH Victor Dupuy- Argenteuil
Groupe hospitalier Sud Ile de France
Hôpital Avicenne,
Hôpital de Tours
Hôpital de la Pitié- Salpêtrière
CH de Compiègne-Noyon


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: Institut François Calot/Centre Hélio-Marin

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

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

location_facility: Hotel Dieu De France Hospital Youssef Souda

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

location_facility: Groupe Hospitalier Sud Réunion Terre Rouge Boissy


title: A Multicentre, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GFT505 Once Daily on Steatohepatitis in Patients With Non-Alcoholic Steatohepatitis (NASH).

summary:
Abdominal obesity and type-2 Diabetes are associated with chronic liver disorders resulting from the accumulation of fat in the liver (steatosis), which may progress towards hepatitis and possibly lead to cirrhosis and liver cancer. NAFLD (Non Alcoholic Fatty Liver Disease) is considered as the most common form of chronic liver disease in adults in the United States, Australia, Asia and Europe. In the USA, the estimated prevalence of NAFLD is 20-30% of the adult population.

Non-alcoholic Steatohepatitis (NASH) is a progressing form of NAFLD, which corresponds to hepatic steatosis associated with inflammation and liver cell injury upon microscopic examination of a liver biopsy. This condition may lead to advanced fibrosis and cirrhosis and deserves serious medical management. Up to now, there is no effective drug which has clearly demonstrated therapeutic efficacy which may help lifestyle and dietary recommendations in the resolution of NASH.

In this context, GENFIT is developing a new liver targeted drug candidate, GFT505, for the treatment of NASH and the reduction of multiple cardiometabolic risk factors associated with the metabolic syndrome and type 2 Diabetes.

This phase IIb study will evaluate the efficacy and safety of GFT505 80mg and 120mg once daily for 52 weeks on the reversal of NASH without worsening of fibrosis, based on liver biopsy assessments.

ReferenceCitation: Ratziu V, Harrison SA, Francque S, Bedossa P, Lehert P, Serfaty L, Romero-Gomez M, Boursier J, Abdelmalek M, Caldwell S, Drenth J, Anstee QM, Hum D, Hanf R, Roudot A, Megnien S, Staels B, Sanyal A; GOLDEN-505 Investigator Study Group. Elafibranor, an Agonist of the Peroxisome Proliferator-Activated Receptor-alpha and -delta, Induces Resolution of Nonalcoholic Steatohepatitis Without Fibrosis Worsening. Gastroenterology. 2016 May;150(5):1147-1159.e5. doi: 10.1053/j.gastro.2016.01.038. Epub 2016 Feb 11. Erratum In: Gastroenterology. 2017 Jun;152(8):2084.

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

repository_institution: Radboud University - Radboud Repository

repository_institution: Newcastle Univesity - Newcastle University ePrints

repository_institution: University of Turin - Institutional Research Information System University of Turin

evidence: oa repository (semantic scholar lookup)

repositories_institution: Nova Science Publishers, Inc. - Nova Science Publishers

lead_sponsor: Genfit

collaborators:
Naturalpha
Premier Research Group plc

sponsor_collaborators:
Genfit
Naturalpha
Premier Research Group plc

location_country:
Germany
Italy
United Kingdom
Romania
Netherlands
Belgium
United States
Spain
France

location_facility:
Site 901
Site 107
Site 801
Site 913
Site 101
Site 204
Site 203
Site 902
Site 503
Site 707
Site 507
Site 927
Site 903
Site 924
Site 205
Site 302
Site 603
Site 104
Site 908
Site 912
Site 916
Site 303
Site 923
Site 930
Site 911
Site 705
Site 917
Site 501
Site 504
Site 602
Site 201
Site 701
Site 202
Site 802
Site 103
Site 921
Site 114
Site 404
Site 919
Site 906
Site 106
Site 111
Site 703
Site 706
Site 808
Site 112
Site 920
Site 102
Site 113
Site 109
Site 601
Site 909
Site 108
Site 803
Site 405
Site 931


lead_sponsor: Shire

summary: The main aim of this study is to see if giving LDX to children and adolescents aged 6-17 years with ADHD decreases symptoms of ADHD.

ReferenceCitation: Coghill D, Banaschewski T, Lecendreux M, Soutullo C, Johnson M, Zuddas A, Anderson C, Civil R, Higgins N, Lyne A, Squires L. European, randomized, phase 3 study of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder. Eur Neuropsychopharmacol. 2013 Oct;23(10):1208-18. doi: 10.1016/j.euroneuro.2012.11.012. Epub 2013 Jan 15.

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories_concat: Zenodo

ReferenceCitation: Coghill DR, Banaschewski T, Lecendreux M, Zuddas A, Dittmann RW, Otero IH, Civil R, Bloomfield R, Squires LA. Efficacy of lisdexamfetamine dimesylate throughout the day in children and adolescents with attention-deficit/hyperactivity disorder: results from a randomized, controlled trial. Eur Child Adolesc Psychiatry. 2014 Feb;23(2):61-8. doi: 10.1007/s00787-013-0421-y. Epub 2013 May 25.

repository_institution: University of Dundee - Discovery Research Portal

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;discovery.dundee.ac.uk;iris.unica.it;www.repositoriosalud.es

publisher_dissemination: Springer

ReferenceCitation: Banaschewski T, Soutullo C, Lecendreux M, Johnson M, Zuddas A, Hodgkins P, Adeyi B, Squires LA, Coghill D. Health-related quality of life and functional outcomes from a randomized, controlled study of lisdexamfetamine dimesylate in children and adolescents with attention deficit hyperactivity disorder. CNS Drugs. 2013 Oct;27(10):829-40. doi: 10.1007/s40263-013-0095-5.

ReferenceCitation: Setyawan J, Yang H, Cheng D, Cai X, Signorovitch J, Xie J, Erder MH. Developing a Risk Score to Guide Individualized Treatment Selection in Attention Deficit/Hyperactivity Disorder. Value Health. 2015 Sep;18(6):824-31. doi: 10.1016/j.jval.2015.06.005. Epub 2015 Aug 20.

location_facility: Università degli Studi di Cagliari, Dipartimento di Neuroscienze

location_facility: Hospital Marítimo, Unidad de Salud Mental Infanto-Juvenil (USMI-J), Carretera del Sanatorio s/n

location_facility: Victoria Hospital, Paediatric Unit, Hayfield Road

location_facility: Praxis für Neuropädiatrie, Schomburgstrasse 120

location_facility: Klinikum der Johannes Gutenberg-Universität Mainz, Klinik und Poliklinik für Kinder-und Jugendpsychiatrie und-psychotherapie,

location_facility: Lighthouse Child Development Centre, Snakes Lane

location_facility: Praxis Dr. med. Friedrich Kaiser und Dr. med. Ingrid Marinesse

location_facility: Hôpital Robert Debré, Service de Psychopathologie de l'Enfant et de l'Adolescent

location_facility: Tayside Childrens Hospital, Clinical Research Facility, Level 4

location_facility: Schwerpunktpraxis für Entwicklung und Lernen, Heinrichsdamm 6

location_facility: Universität Würzburg, Klinik und Poliklinik fuer Kinder-und Jugendpsychiatrie und Psychotherapie

location_facility: ZiekenhuisNetwerk Antwerpen, Commandant Weynsstraat 165, Campus Hoge Beuken

location_facility: Szpital Uniwersytecki im. dr. Antoniego Jurasza w Bydgoszczy

location_facility: Hospital Universitario de Canarias C/Ofra

location_facility: Ryegate Children's Centre, Tapton Crescent Road

location_facility: Azienda Ospedaliera della 2 Universita di Napoli

location_facility: Afdeling Psychiatrie, UZ Herestraat 49, Bus 07003

location_facility: Utvecklingsneurologiska Enheten (UNE), BUC, Lockerudsv 12

location_facility: Gyermek és Ifjúságpszichiátriai Szakrendelés és Gondozó

location_facility: Universitair Ziekenhuis Gent, Kinder-en Jeugdpsychiatrie, De Pintelaan 185

location_facility: Universitair Medisch Centrum Sint Radboud, Reinier Postlaan 10

location_facility: Centre Hospitalier Charles Perrens, Bordeaux, Service de Psychiatrie de l'Enfant et de l'Adolescent

location_facility: Hôpital Gui de Chauliac, 80, avenue Augustin Fliche

location_facility: Samodzielny Publiczny Dzieciecy Szpital Kliniczny

location_facility: Astrid Lindgren Children's Hospital, Karolinska University Hospital

location_facility: Zentralinstitut für Seelische Gesundheit Mannheim, Klinik für Psychiatrie und Psychotherapie des Kindes-und Jug, J4/J5

location_facility: Hospital Ramón y Cajal, Servicio de psiquiatría

location_facility: Wojewodzki Osrodek Lecznictwa Psychiatrycznego

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: Complejo Hospitalario Universitario de Badajoz

location_facility: Medizinisches Studienzentrum Würzburg, Augustinerstrasse 10

location_facility: Universitatsklinikum Gießen und Marburg GmbH, Hans-Sachs-Strasse 4

location_facility: Basildon Hospital, Child Developement Centre, Nethermayne

location_facility: Clínica Universitaria de Navarra, Unidad de Psiquiatría Infantil y Adolescente, Dept. de Psiquiatría y Psicología Médica

location_facility: Barn och Ungdomsmedicin klinik Mölnlycke, Ekdalavägen 2,Box 9

title: A Phase III, Randomised, Double-Blind, Multicentre, Parallel-Group, Placebo- and Active-Controlled, Dose-Optimisation Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Sweden
Netherlands
Belgium
Spain
France


title: InSaKa Trial: Insulin Dextrose Infusion Versus Nebulized Salbutamol Versus Combination of Salbutamol and Insulin Dextrose in Acute Hyperkalemia: a Randomized Clinical Trial

acronym: InSaKa

summary:
Hyperkalemia is a common electrolyte disorder, especially among patients with chronic kidney disease, diabetes mellitus, or heart failure. Globally, the reported incidence of hyperkalemia varies from 1.1 to 10 per 100 hospitalizations, depending on the patient cohort and comorbidities. Hyperkalemia is a potentially life-threatening electrolyte disturbance that can be fatal if left untreated. Several studies have established the association between hyperkalemia and all-cause mortality. Because of the deleterious cardiac effects of hyperkalemia, its management is an emergency intervention. However, robust evidence is lacking to guide the emergency management of patients with hyperkalemia. Emergency treatment approaches are largely based on small studies, anecdotal experience, and traditionally accepted practice patterns within institutions. Therefore, a rigorous evaluation of the first-line treatments of hyperkalemia in emergency departments is needed and a large scale randomized clinical trial is warranted before robust recommendations for clinical practice can be made. Our clinical trial will improve the safety of patients with acute hyperkalemia and will help clinicians in their day by day practice to choose the treatment that significantly reduces morbidity and mortality during acute hyperkalemia management. Our results will be delivered in a timely fashion, owing to the high prevalence of hyperkalemia in the emergency department setting and to the commitment of the INI-CRCT network of Excellence, along with ED specialists used to work jointly.

the primary objective of our trial is to compare insulin/dextrose intravenous infusion, nebulized salbutamol or combination of nebulized salbutamol and insulin/dextrose intravenous infusion to reduce serum potassium concentration at 60 minutes, as first-line treatment, in emergency departments.

status: Recruiting

ReferenceCitation: Montassier E, Lemoine L, Hardouin JB, Rossignol P, Legrand M. Insulin glucose infusion versus nebulised salbutamol versus combination of salbutamol and insulin glucose in acute hyperkalaemia in the emergency room: protocol for a randomised, multicentre, controlled study (INSAKA). BMJ Open. 2020 Aug 26;10(8):e039277. doi: 10.1136/bmjopen-2020-039277.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Francois Rabelais - Tours

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

repository_institution: University of California - eScholarship University of California

repositories:
HAL
PubMed Central
escholarship.org

repositories_concat: HAL;PubMed Central;escholarship.org

ipd_sharing_description: Trial data are not publicly available owing to data privacy, but access to the anonymised dataset can be obtained from the corresponding author on reasonable request.

lead_sponsor: Nantes University Hospital

location_facility: La Pitié Salpêtrière University Hospital

status_simplified: Ongoing

appel_a_projets: PHRCN

region: Pays de la Loire

nom_etablissement: CHU DE NANTES

type_etablissement: CH

acronyme: InSaKa

discipline_principale: emergency medicine

nom_porteur: MONTASSIER

prenom_porteur: Emmanuel


acronym: BERGAMOT

lead_sponsor: Hoffmann-La Roche

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.

ReferenceCitation: Sandborn WJ, Panes J, Danese S, Sharafali Z, Hassanali A, Jacob-Moffatt R, Eden C, Daperno M, Valentine JF, Laharie D, Baia 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. 2023 Jan;8(1):43-55. doi: 10.1016/S2468-1253(22)00303-X. Epub 2022 Oct 12.

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 alpha4beta7 and alphaEbeta7 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.

repositories_concat: PubMed Central;escholarship.org

repositories_institution: University of California - eScholarship University of California

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.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

location_facility: Digestive Care Associates, A Medical Corporation

location_facility: Clinical Hospital Center Sestre Milosrdnice

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

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

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

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

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej SONOMED

location_facility: University of North Carolina At Chapel Hill

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

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

location_facility: McGuire Research Institute; Gastroenterology

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

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

location_facility: Digestive Disease Institute; Virginia Mason Medical Center

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: CI of Kyiv RC Regional Clinical Hospital #2

location_facility: Innovative Medical Research of South Florida

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: The University of Chicago Medical Center

location_facility: SBEI HPE Altai StateMedicalUniversityofMoH andSD

location_facility: Zespó Przychodni Specjalistycznych PRIMA

location_facility: Tel Aviv Sourasky Medical Center; Pharmacy

location_facility: University Hospital Medical Center Bezanijska kosa

location_facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza

location_facility: Zuyderland Medisch Centrum - Sittard Geleen

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Irkutsk State Medical Academy of Continuing Education

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

location_facility: Texas Digestive Disease Consultants - Southlake

location_facility: Elblaski Szpital Specjalistyczny z Przychodnia SP ZOZ

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska

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

location_facility: Royal Wolverhampton hospital; McHale Building

location_facility: Queen Elizabeth II Health Sciences Centre; Gastroenterology Research

location_facility: Azienda Ospedaliera San Camillo Forlanini

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

location_facility: University of California San Diego Medical Center

location_facility: Hospital Universitario Puerta de Hierro Majadahonda; Hepatology studies

location_facility: Texas Digestive Disease Consultants - Dallas

location_facility: Charite-Campus Virchow Klinikum; Hepatologie und Gastroenterologie

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

location_facility: Medizinische Hochschule Hannover; Gastroenterology and Hepatology dept

location_facility: Riga East Clinical University Hospital; Clinic Gailezers

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

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

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: Hospital de Base de Sao Jose do Rio Preto

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

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

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

location_facility: Gastroenterology Center of the MidSouth PC

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

location_facility: Private Small Enterprise Medical Center Pulse

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

location_facility: SBEIHPE Novosibirsk State Medical University

location_facility: University of Texas Southwestern Medical Center; Internal Medicne

location_facility: Baylor College of Medicine; Gastroenterology

location_facility: Gastroenterology Associates of Central Georgia

location_facility: Hacettepe University Medical Faculty; Gastroenterology

location_facility: Wolfson Medical Center; Obstetrics and Gynecology

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

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

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

location_facility: Hospital do Servidor Público Estadual/HSPE-SP

location_facility: University of Florida College of Medicine

location_facility: Kocaeli Universitesi Tip Fakultesi; Infectious Diseases

location_facility: Hospital Universitario Clementino Fraga Filho - UFRJ; Gastroenterologia

location_facility: Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH

location_facility: Southwest Gastroenterology; DM Clinical Research

location_facility: Hospital Clínic i Provincial; Servicio de Farmacia

location_facility: EuroMediCare Szpital Specjalistyczny z Przychodnią we Wrocławiu

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

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

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

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: Policlinico Universitario Agostino Gemelli; Farmacia

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

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Acibadem Kozyatagi Hospital; Gastroenterology

location_facility: Nottingham University Hospitals Queen's Medical Centre

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: Haydarpasa Numune Training and Research Hospital; Medical Oncology

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

location_facility: BHI of Omsk region Clinical Oncology Dispensary

location_facility: Klinikum Mannheim GmbH Universitätsklinikum

location_facility: University Hospital - London Health Sciences Centre

location_facility: Hospital Universitari i Politecnic La Fe

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

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

location_facility: L2IP -Instituto de Pesquisas Clínicas Ltda.

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

location_facility: CHA Bundang Medical Centre; CHA university

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

location_facility: Seoul National University Bundang Hospital

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

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Asst Fatebenefratelli Sacco (Fatebenefratelli)

location_facility: Peak Gastroenterology Associates; Gastroenterology

location_facility: McGill University Health Centre - Glen Site

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: University of Mississippi Medical Center; Division of Gastroenterology

location_facility: Medical Center of Limited Liability Company Medical Clinic Blagomed

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: Great Lakes Gastroenterology Research, LLC

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

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

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


acronym: COTTONWOOD

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

location_facility: Hospital Raja Perempuan Zainab II; Department of Medicine

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

location_facility: Nottingham University Hospitals; QMC Campus

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

location_facility: A.Novak Transcarpathian Regional Clinical Hospital

location_facility: CI Kherson Afanasii and Olha Tropiny City Clinical Hospital

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

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

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

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

location_facility: Medical Center "Nov Rehabilitatsionen Tsentar", EOOD

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej SONOMED

location_facility: Gemeinschaftspraxis Dres. Joachim Mueller und Steffi Appelt

location_facility: University of California, Irvine Medical Center

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

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta

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

location_facility: McGuire Research Institute; Gastroenterology

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

location_facility: Azienda Ospedaliero Universitaria San Martino

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

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

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

location_facility: Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont

location_facility: University of North Carolina at Chapel Hill

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

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: Azienda Ospedaliera Fatebenefratelli e Oftalmico

location_facility: Ålborg Universitets Hospital; Gastromedicinsk

location_facility: CI of Kyiv RC Regional Clinical Hospital #2

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: Pusat Perubatan Universiti Kebangsaan Malaysia

location_facility: Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy

location_facility: SBEI HPE Altai StateMedicalUniversityofMoH andSD

location_facility: Gazi University Medical Faculty; Gastroenterology

location_facility: Zespó Przychodni Specjalistycznych PRIMA

location_facility: Atlanta Gastroenterology Specialists, PC

location_facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza

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

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

location_facility: Fundacion Hospital de Alcorcon; Servicio de Digestivo

location_facility: University of Mississippi Medical Center

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

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

location_facility: Diagnostic Consultation Center CONVEX EOOD

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Bnai Zion Medical Center; Internal Medicine

location_facility: Irkutsk State Medical Academy of Continuing Education

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

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska

location_facility: Texas Digestive Disease Consultants - Southlake

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

location_facility: Hospital Universitari de Girona Dr Josep Trueta

location_facility: Queen Elizabeth II Health Sciences Centre; Gastroenterology Research

location_facility: Medical and Sanitary Division of Severstal

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Azienda Ospedaliera San Camillo Forlanini

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

location_facility: University of California San Diego Medical Center

location_facility: CECIP - Centro de Estudos Clínicos do Interior Paulista

location_facility: Wojewodzki Specjalistyczny Szpital w Olsztynie

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

location_facility: Keimyung University Dongsan Medical Center

location_facility: Texas Digestive Disease Consultants - Dallas

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

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

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

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

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

location_facility: LLC International Medical Centre ?SOGAZ?

location_facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

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

location_facility: Cliniques Universitaires Saint-Luc; Pharmacy

location_facility: Fondazione Poliambulanza Istituto Ospedaliero

location_facility: Azienda Ospedaliera Universitaria Careggi

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

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

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel

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

location_facility: Private Small Enterprise Medical Center Pulse

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

location_facility: Rigshospitalet; Medicinsk gastroenterologisk klinik

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

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

location_facility: Asheville Gastroenterology Associates, P.A.

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

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Gastroenterology Associates of Central Georgia

location_facility: Clinical Hospital Sveti Duh; Department of Neurology

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

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

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

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

location_facility: Medizinisches Zentrum Klinikum Lueneburg

location_facility: Hamburgisches Forschungsinstitut fuer CED

location_facility: Pavlov First Saint Petersburg State Medical University

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

location_facility: Hospital do Servidor Público Estadual/HSPE-SP

location_facility: Hospital Universitario Clementino Fraga Filho - UFRJ

location_facility: Innovative Medical Research of South Florida, Inc.

location_facility: Kocaeli Universitesi Tip Fakultesi; Infectious Diseases

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

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

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

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

location_facility: Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH

location_facility: Phylasis Clinicas Research S de RL de CV

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

location_facility: University of California at San Francisco

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

location_facility: Universitaetsklinikum Jena; Apotheke des Uniersitätsklinikums Jena

location_facility: King Edward Memorial Hospital Research Centre

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Stavropol Regional Clinical Diagnostic Consultative Center

location_facility: M. S. Ramaiah Medical College and Hospital

location_facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: Hospital Universitario Walter Cantidio - UFC

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

location_facility: Haydarpasa Numune Training and Research Hospital; Medical Oncology

location_facility: GZA Ziekenhuizen - Campus Sint-Vincentius

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

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

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

location_facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Kyungpook National University Medical Center

location_facility: RCI Chernivtsi RCH Gastroenterology Bukovinsky SMU

location_facility: BHI of Omsk region Clinical Oncology Dispensary

location_facility: Hospital da Senhora da Oliveira Guimarães

location_facility: Klinikum Mannheim GmbH Universitätsklinikum

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

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

location_facility: Klaipeda Seamen's Hospital, Public Institution

location_facility: University Hospital - London Health Sciences Centre

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

location_facility: Hospital Universitari i Politecnic La Fe

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

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

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

location_facility: Azienda Ospedaliero Universitaria di Parma

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

location_facility: Markhot Ferenc Oktato Korhaz es Rendelointezet

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

location_facility: University General Hospital of Heraklion

location_facility: CI of Kyiv RC Kyiv Regional Clinical Hospital

location_facility: Launceston General Hospital; Gastroenterology Research

location_facility: Ospedale di Circolo; Neuropsichiatria Infantile

location_facility: Rocky Mountain Gastroenterology Associates

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

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

location_facility: Northwestern University Feinberg School Of Medicine

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh

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

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

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

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