title: Randomized Clinical Trial to Evaluate the Interest of a Down-scaled Treatment Strategy Using Dual Therapy (Nucleoside Analogs) in HIV Infected Patients Already Being Treated Using Triple Therapy, Who Present With a Successful Virological Control and for Which the HIV Reservoir is Low to Moderate

acronym: TRULIGHT

summary:
In the early 2000s, the "TRILEGE©" study was realized to determine if the reductive anti retroviral strategy from an initial triple therapy (based on a protease inhibitor as the third agent) towards a dual therapy of nucleoside analogs (in particular the association of "zidovudine +lamivudine") for patients infected by HIV and stabilized for at least 3 months at a threshold value of 400 copies/ml, would allow to obtain a well-controlled plasmatic viral load, with an aim to reduce the long-term side effects of the treatment.

The afore mentioned study showed that the reductive anti retroviral strategy was a failure. No study has as yet to revaluate this strategy, in particular in the current context of antiretroviral treatments.

Indeed, modern nucleoside inhibitors (Kivexa®, Truvada®) have extended half-lives as well as a superior intrinsic power as compared to treatments proposed in the initial "TRILEGE©" study. Furthermore, the better quality of current triple therapy (as compared to that used 10 years ago) has lead to substantial viral reservoir reduction.

Currently, a small number of patients is being successfully treated in the long-term (viral load < 20 copies/ml) using nucleoside analog dual therapy. The particular characteristics of these patients have yet to be thoroughly investigated.

The patients concerned were all treated prematurely before ever passing below 200 lymphocytes T CD4/mm3. It occurred that all these patients presented a low viral reservoir as measured by HIV DNA quantification (< 2,7 log copies/106 PBMC).

Therefore, by targeting patients who have (1) a strong immune restoration, (2) a low HIV DNA value and (3) a very good observance, the investigators emit the hypothesis that, reductive anti retroviral strategy that would consist in changing from a conventional triple therapy towards a Nucleoside reverse-transcriptase inhibitors dual therapy, could allow for durable control of viral replication with the concomitant benefice of reduced antiretroviral side effects and cost.

ReferenceCitation: Prazuck T, Verdon R, Le Moal G, Ajana F, Bernard L, Sunder S, Roncato-Saberan M, Ponscarme D, Etienne M, Viard JP, Pasdeloup T, Darasteanu I, Pialoux G, de la Blanchardière A, Avettand-Fènoël V, Parienti JJ, Hocqueloux L; TRULIGHT Study Team. Tenofovir disoproxil fumarate and emtricitabine maintenance strategy in virologically controlled adults with low HIV-1 DNA: 48 week results from a randomized, open-label, non-inferiority trial. J Antimicrob Chemother. 2021 May 12;76(6):1564-1572. doi: 10.1093/jac/dkab038.

name: Service des Maladies Infectieuses et Tropicales, CHR d’Orléans—La Source, Orléans, France

family: Prazuck

full_name: Thierry Prazuck

given: Thierry

name: Service des Maladies Infectieuses, CHU Côte de Nacre, Caen, France

family: Verdon

full_name: Renaud Verdon

given: Renaud

name: Service des Maladies Infectieuses, CHU La Milétrie, Poitiers, France

family: Le Moal

full_name: Gwenaël Le Moal

given: Gwenaël

name: Service des Maladies Infectieuses, CHU Lille Tourcoing, France

family: Ajana

full_name: Faïza Ajana

given: Faïza

name: Service des Maladies Infectieuses, CHU Bretonneau, Tours, France

family: Bernard

full_name: Louis Bernard

given: Louis

name: Service des Maladies Infectieuses et Tropicales, CHG de Niort, Niort, France

family: Sunder

full_name: Simon Sunder

given: Simon

name: Service des Maladies Infectieuses, Groupe Hospitalier de La Rochelle—Ré – Aunis, La Rochelle, France

family: Roncato-Saberan

full_name: Mariam Roncato-Saberan

given: Mariam

name: Service des Maladies Infectieuses, CHU Saint-Louis, Paris, France

family: Ponscarme

full_name: Diane Ponscarme

given: Diane

name: Service des Maladies Infectieuses, CHU de Rouen, Rouen, France

family: Etienne

full_name: Manuel Etienne

given: Manuel

name: Centre de Diagnostic et Thérapeutique, Hôtel-Dieu, Paris, France

family: Viard

full_name: Jean-Paul Viard

given: Jean-Paul

name: Service de Médecine Interne, CH de Saintonge, Saintes, France

family: Pasdeloup

full_name: Thierry Pasdeloup

name: Service des Maladies Infectieuses, CH de Chartres, Chartres, France

family: Darasteanu

full_name: Iuliana Darasteanu

given: Iuliana

name: Service des Maladies Infectieuses, CHU Tenon, Paris, France

family: Pialoux

full_name: Gilles Pialoux

given: Gilles

family: de la Blanchardière

full_name: Arnaud de la Blanchardière

given: Arnaud

name: Université de Paris, Faculté de Médecine, INSERM, U1016, CNRS, UMR8104, Laboratoire de Microbiologie clinique, unité de virologie, CHU Necker, Paris, France

family: Avettand-Fènoël

full_name: Véronique Avettand-Fènoël

given: Véronique

name: EA 2656 GRAM 2.0, Caen Université, Caen, France

family: Parienti

full_name: Jean-Jacques Parienti

given: Jean-Jacques

family: Hocqueloux

full_name: Laurent Hocqueloux

given: Laurent

family: Fourmy

full_name: Adeline Fourmy

given: Adeline

family: Mureau

full_name: Elody Mureau

given: Elody

family: Juteau

full_name: Nathalie Juteau

given: Nathalie

family: Giraudeau

full_name: Bruno Giraudeau

given: Bruno

family: Dargere

full_name: Sylvie Dargere

given: Sylvie

family: Michon

full_name: Jocelyn Michon

given: Jocelyn

ReferenceCitation: Hocqueloux L, Gubavu C, Prazuck T, De Dieuleveult B, Guinard J, Sève A, Mille C, Gardiennet E, Lopez P, Rouzioux C, Lefeuvre S, Avettand-Fènoël V. Genital Human Immunodeficiency Virus-1 RNA and DNA Shedding in Virologically Suppressed Individuals Switching From Triple- to Dual- or Monotherapy: Pooled Results From 2 Randomized, Controlled Trials. Clin Infect Dis. 2020 Apr 15;70(9):1973-1979. doi: 10.1093/cid/ciz511.

name: Pôle de Biopathologies, Centre Hospitalier Régional d’Orléans

name: Université Paris Descartes, Sorbonne Paris Cité

name: Centre national de la recherche scientifique

name: Institut national de la santé et de la recherche médicale U1016, Institut Cochin

name: Laboratoire de Microbiologie clinique, Hôpital Necker-Enfants Malades, Assistance Publique-Hôpitaux de Paris France

title: Genital Human Immunodeficiency Virus–1 RNA and DNA Shedding in Virologically Suppressed Individuals Switching From Triple- to Dual- or Monotherapy: Pooled Results From 2 Randomized, Controlled Trials

location_facility: Unité des Maladies Infectieuses, CHU de CAEN

location_facility: Service des Maladies Infectieuses et tropicales, APHP SAINT LOUIS

location_facility: Service d'Immunologie Clinique centre de Vaccination anti- VIH ANRS Hopital Henri- Mondor

location_facility: Service de Médecine Interne, CH de SAINTONGE- BP 326

location_facility: Service Universitaire des Maladies Infectieuses et du Voyageur, CH DRON

location_facility: Consultation Maladies Infectieuses, Chu de Poitiers, Cedex

location_facility: Service de Pneumologie, centre Hospitalier Fontenoy, CH de CHARTRES

location_facility: Service des Maladies Infectieuses, CHR Orléans La Source, ORLEANS CEDEX 2

location_facility: Centre de diagnostic et thérapeutique, Hopital Hotel Dieu

location_facility: Service de Medecine Interne et Maladies Infectieuses, CHRU BRETONNEAU, TOURS CEDEX9

location_facility: Service des maladies Infectieuses et tropicales, CH GEORGES RENON

location_facility: Service de Médecine Interne et Maladies Infectieuses, Groupe Hospitalier La Rochelle, Cedex 01


title: Safety and Efficacy of Endovascular Treatment of Unruptured Intracranial Aneurysms in the Prevention of Aneurysmal Haemorrhages: A Randomized Comparison With Indefinite Deferral of Treatment in 2002 Patients Followed for 10 Years

acronym: TEAM

summary: The management of patients with unruptured aneurysms is controversial. Patients with unruptured aneurysms may suffer intracranial hemorrhage, but the incidence of this event is still debated. Endovascular treatment can prevent rupture, but involves immediate risks; furthermore, successful treatment does not eliminate all risks. A randomized trial may be the best way to demonstrate the potential benefits of endovascular over conservative management of unruptured aneurysms.

study_start_date_type: Actual

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Raymond J, Meder JF, Molyneux AJ, Fox AJ, Johnston SC, Collet JP, Rouleau I; Trial on Endovascular Aneurysm Management (TEAM) collaborative group. Trial on endovascular treatment of unruptured aneurysms (TEAM): study monitoring and rationale for trial interruption or continuation. J Neuroradiol. 2007 Mar;34(1):33-41. Review.

ReferenceCitation: Raymond J, Meder JF, Molyneux AJ, Fox AJ, Johnston SC, Collet JP, Rouleau I; Trial On Endovascular Aneurysm Management Team Collaborative Group. Unruptured intracranial aneurysms: the unreliability of clinical judgment, the necessity for evidence, and reasons to participate in a randomized trial. J Neuroradiol. 2006 Oct;33(4):211-9. Review.

ReferenceCitation: Raymond J, Guilbert F, Weill A, Roy D. Unruptured intracranial aneurysms: a call for a randomized clinical trial. AJNR Am J Neuroradiol. 2006 Feb;27(2):242-3.

ReferenceCitation: Raymond J, Guilbert F, Weill A, Georganos SA, Juravsky L, Lambert A, Lamoureux J, Chagnon M, Roy D. Long-term angiographic recurrences after selective endovascular treatment of aneurysms with detachable coils. Stroke. 2003 Jun;34(6):1398-403. Epub 2003 May 29.

ReferenceCitation: Raymond J, Chagnon M, Collet JP, Guilbert F, Weill A, Roy D. A randomized trial on the safety and efficacy of endovascular treatment of unruptured intracranial aneurysms is feasible. Interv Neuroradiol. 2004 Jun 29;10(2):103-12. Epub 2004 Oct 22.

ReferenceCitation: Raymond J, Molyneux AJ, Fox AJ, Johnston SC, Collet JP, Rouleau I; TEAM Collaborative Group. The TEAM trial: safety and efficacy of endovascular treatment of unruptured intracranial aneurysms in the prevention of aneurysmal hemorrhages: a randomized comparison with indefinite deferral of treatment in 2002 patients followed for 10 years. Trials. 2008 Jul 16;9:43. doi: 10.1186/1745-6215-9-43.

ReferenceType: derived

ReferenceCitation: Naggara O, Raymond J, Guilbert F, Roy D, Weill A, Altman DG. Analysis by categorizing or dichotomizing continuous variables is inadvisable: an example from the natural history of unruptured aneurysms. AJNR Am J Neuroradiol. 2011 Mar;32(3):437-40. doi: 10.3174/ajnr.A2425. Epub 2011 Feb 17.

family: Naggara

full_name: O. Naggara

given: O.

sequence: first

family: Raymond

full_name: J. Raymond

given: J.

sequence: additional

family: Guilbert

full_name: F. Guilbert

given: F.

family: Roy

full_name: D. Roy

given: D.

family: Weill

full_name: A. Weill

given: A.

family: Altman

full_name: D.G. Altman

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: American Journal of Neuroradiology

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: American Society of Neuroradiology (ASNR)

title: Analysis by Categorizing or Dichotomizing Continuous Variables Is Inadvisable: An Example from the Natural History of Unruptured Aneurysms

ReferenceCitation: Raymond J. Incidental intracranial aneurysms: rationale for treatment. Curr Opin Neurol. 2009 Feb;22(1):96-102. Review.

lead_sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

location_country:
United States
United Kingdom
Canada
France

location_facility: TEAM European Coordination Centre NVRU- Radcliffe Infirmary

location_facility: TEAM France Coordination Unit - CHU Reims CRICAM

location_facility: CHUM Notre-Dame Hospital / TEAM clinical research unit (Head office)

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Unknown


title: Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation

acronym: ZERO-AF

summary: The purpose of this study is to establish the safety and effectiveness of the Blazer Open-Irrigated radiofrequency ablation catheter for the treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.

status: Completed

lead_sponsor: Boston Scientific Corporation

location_country:
United States
Sweden
Spain
France
Czechia
Australia
Portugal
Germany
United Kingdom

location_facility: Hospital of the University of Pennsylvania

location_facility: University of Texas Health Science Center

location_facility: University of North Carolina Medical Center

location_facility: Texas Cardiac Arrhythmia Research Foundation

location_facility: Strong Memorial Hospital of the University of Rochester

lead_sponsor_type: industriel

status_simplified: Completed


title: Clinical Trial Comparing Two Electroconvulsive Therapy (ECT) Application Schemas in Ultra-resistant Schizophrenia

acronym: SURECT

summary: The effects of the ECT in schizophrenia ultra-resistant were studied in short times (4-6 months in most studies with follow-up). The literature identified a high relapse rate of 32% in the weeks to months after ECT discontinuation. The use of the ECT in the prevention of the relapse is partially known. In an empirical way, experts recommend protocols of prevention of the relapse going from 6 to 12 months. Nevertheless, the profit of a long cure (12 months) compared with a short cure (6 months) was never determined. Therefore, the investigators decided to lead a prospective randomized controlled study in order to compare the response rates between the two strategies of clozapine and ECT combinations applied to URS patients. The treatment consisted either in a short therapy of six months or a longer course of therapy of twelve months. To the investigators' knowledge, it is the first study which compares two ECT strategies (both the short duration and the longer one) for the treatment of URS patients.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Moulier V, Krir MW, Dalmont M; SURECT Group, Guillin O, Rothärmel M. A prospective multicenter assessor-blinded randomized controlled study to compare the efficacy of short versus long protocols of electroconvulsive therapy as an augmentation strategy to clozapine in patients with ultra-resistant schizophrenia (SURECT study). Trials. 2021 Apr 15;22(1):284. doi: 10.1186/s13063-021-05227-3.

family: Moulier

full_name: Virginie Moulier

given: Virginie

family: Krir

full_name: Mohamed Wassim Krir

given: Mohamed Wassim

family: Dalmont

full_name: Marine Dalmont

given: Marine

family: Guillin

full_name: Olivier Guillin

given: Olivier

family: Rothärmel

full_name: Maud Rothärmel

given: Maud

currency_apc_doaj: GBP

journal_name: Trials

oa_colors: green gold

evidence: oa journal (via doaj)

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ipd_sharing: No

lead_sponsor: Centre Hospitalier du Rouvray

location_facility:
Clermont-Ferrand Hospital
CHU de Caen
Montpellier University Hospital
EPS Ville Evrard
Centre Hospitalier Henri Laborit
CHU de Nantes
Centre Hospitalier Saint Anne
Centre Hospitalier Charles Perrens
Centre Hospitalier de Cadillac
CHU de Toulouse

status_simplified: Ongoing


title: Safety and Effectiveness IDE Trial for Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation

acronym: FROZEN-AF

summary: To establish the safety and effectiveness of the Boston Scientific Cardiac Cryoablation System for treatment of symptomatic, drug refractory, recurrent, paroxysmal atrial fibrillation (AF).

status: Active, not recruiting

ipd_sharing_description: No requests for study data have been made at this time, however Boston's Scientific's policy on data sharing can be found at http://www.bostonscientific.com/en-US/data-sharing-requests.html

location_country:
Italy
United States
Hong Kong
Netherlands
Germany
France
Belgium
Canada
Taiwan

location_facility: Christus Trinity Mother Frances Health System

location_facility: Virginia Commonwealth University Health System

location_facility: Institut universitaire de Cardiologie et de Pneumologie de Quebec

location_facility: Erasmus MC- University Medical Center Rotterdam


title: Volumétrie Optimisée en Radiologie : intérêt en IRM Cérébrale pédiatrique Dans l'Exploration de l'épilepsie Focale

acronym: ORACLE

summary: Multicentre cross-sectional study with prospective recruitment comparing the detection rate of lesions on brain MRI without and with quantitative volumetry and T1 relaxometry information during the management of children with suspected focal epilepsy.

study_start_date_type: Anticipated

status: Not yet recruiting

study_type: Observational

time_perspective: Prospective

ipd_sharing: Undecided

lead_sponsor: University Hospital, Tours

location_facility:
CHU Angers
CHU Montpellier
Hôpital Clocheville
CHU Grenoble
CHU Rennes

intervention_type: Other


type: Registry Identifier

type: Other Identifier

title: Impact d'un Bilan Clinique structuré (MIDSA), de sa Restitution et de l'Accompagnement au Changement Sur l'Engagement Dans le Soin (évalué Par l'échelle URICA) d'Auteurs d'Infraction à caractère Sexuel : Essai contrôlé randomisé Multicentrique en Ouvert

acronym: EV-AICS

summary: Evaluate the effectiveness of an intervention including the clinical assessment carried out with the (Multidimensional Inventory of Development, Sex, and Aggression) MIDSA and the review of the results with the professional in charge of the subject on the adherence and commitment to the care of the sexual offenders.

primary_purpose: Health Services Research

location_facility: CH LE Vinatier - Service de Psychiatrie Légale

location_facility: CHU Montpellier Lapeyronie - CRIAVS Languedoc-Roussillon

location_facility: CHU Poitiers Henri Laborit - CRIAVS - CMP Espace Vienne - SMPR

intervention_type: Behavioral


title: The NIPA Study: A Randomized Double-blind Control Clinical Trial Naloxegol Administration to Prevent Opioids Induced Gastrointestinal Motility Disturbance in Brain Injured PAtients

acronym: NIPA

summary:
Impaired gastrointestinal transit (IGT) especially constipation, is common among patients under mechanical ventilation, occurring in up to 80 % of the patients during the first week, and has been associated with worse outcome in intensive care unit (ICU). Although IGT in critically ill patients is multifactorial and some components are due to complex disease, there is increasing evidence that exogenous opioids contribute to bowel dysmotility.

Sedatives and especially opioids are largely used in the brain injured population to control intracranial pression, reduce metabolic rate, manage or prevent seizures, and improve mechanical ventilator synchrony. Therefore, brain injured patients are particularly at risk to develop IGT. The occurrence of IGT is associated with adverse outcomes in intensive care unit. Both gastric reflux and impaired peristaltic contractions are associated with ventilator-acquired pneumonia.

The actual challenge is to prevent motility disorders before it occurs. A preventive strategy could in turn reduce the occurrence of complications related to impaired gastrointestinal transit such as ventilator-acquired pneumonia, bacteremia etc. It could also reduce the complications of feed intolerance and thus reduce morbidity and mortality in ICU.

Naloxegol is a polyethylene glycol derivative of naloxol, which is a derivative of naloxone and a peripherally acting µ-opioid receptor antagonist. Contrary to naloxone, naloxegol has a very low penetration into the central nervous system, therefore it could be a relevant option for ileus prevention without the risk of impaired sedation.

The aim of our study is to assess the efficacy of the administration of naloxegol on the onset of early constipation and early ventilator-acquired pneumonia in brain injured patients receiving opioids for analgosedation.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
CHU Clermont-Ferrand
Hôpital La Pitié Salpétrière (APHP)
CHU Bordeaux
CHU Nantes
CHU Brest

intervention_type: Drug


title: ANRS CO10 EPF - Cohort of HIV-infected Children

acronym: EPF

summary: The purpose of this study is to describe the conditions of access to early treatment of children infected with HIV, their management on the long-term, and impact on growth, clinical and immunovirological prognosis, adherence to treatment, living conditions

ReferenceType: result

ReferenceCitation: Frange P, Faye A, Avettand-Fenoël V, Bellaton E, Descamps D, Angin M, David A, Caillat-Zucman S, Peytavin G, Dollfus C, Le Chenadec J, Warszawski J, Rouzioux C, Sáez-Cirión A; ANRS EPF-CO10 Pediatric Cohort and the ANRS EP47 VISCONTI study group. HIV-1 virological remission lasting more than 12 years after interruption of early antiretroviral therapy in a perinatally infected teenager enrolled in the French ANRS EPF-CO10 paediatric cohort: a case report. Lancet HIV. 2016 Jan;3(1):e49-54. doi: 10.1016/S2352-3018(15)00232-5. Epub 2015 Dec 9.

family: Frange

full_name: Pierre Frange

given: Pierre

family: Faye

full_name: Albert Faye

given: Albert

family: Avettand-Fenoël

full_name: Véronique Avettand-Fenoël

given: Véronique

family: Bellaton

full_name: Erianna Bellaton

given: Erianna

family: Descamps

full_name: Diane Descamps

given: Diane

family: Angin

full_name: Mathieu Angin

given: Mathieu

family: David

full_name: Annie David

given: Annie

family: Caillat-Zucman

full_name: Sophie Caillat-Zucman

given: Sophie

family: Peytavin

full_name: Gilles Peytavin

given: Gilles

family: Dollfus

full_name: Catherine Dollfus

given: Catherine

family: Le Chenadec

full_name: Jerome Le Chenadec

given: Jerome

family: Warszawski

full_name: Josiane Warszawski

given: Josiane

family: Rouzioux

full_name: Christine Rouzioux

given: Christine

family: Sáez-Cirión

full_name: Asier Sáez-Cirión

given: Asier

journal_name: The Lancet HIV

oa_host_type: repository

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

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Sorbonne Paris Nord

repository_normalized: HAL

version: submittedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Ecole polytechnique

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Aupiais C, Faye A, Le Chenadec J, Rouzioux C, Bouallag N, Laurent C, Blanche S, Dollfus C, Warszawski J; ANRS EPF-CO10 French Pediatric Cohort. Interruption of cART in clinical practice is associated with an increase in the long-term risk of subsequent immunosuppression in HIV-1-infected children. Pediatr Infect Dis J. 2014 Dec;33(12):1237-45. doi: 10.1097/INF.0000000000000450.

family: Aupiais

full_name: Camille Aupiais

given: Camille

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Interruption of cART in Clinical Practice Is Associated With an Increase in the Long-Term Risk of Subsequent Immunosuppression in HIV-1-Infected Children

ReferenceCitation: Sofeu CL, Warszawski J, Ateba Ndongo F, Penda IC, Tetang Ndiang S, Guemkam G, Makwet N, Owona F, Kfutwah A, Tchendjou P, Texier G, Tchuente M, Faye A, Tejiokem MC; ANRS-PEDIACAM Study Group. Low birth weight in perinatally HIV-exposed uninfected infants: observations in urban settings in Cameroon. PLoS One. 2014 Apr 3;9(4):e93554. doi: 10.1371/journal.pone.0093554. eCollection 2014.

title: Low Birth Weight in Perinatally HIV-Exposed Uninfected Infants: Observations in Urban Settings in Cameroon

ReferenceCitation: Blanche S, Scott-Algara D, Le Chenadec J, Didier C, Montange T, Avettand-Fenoel V, Rouzioux C, Mélard A, Viard JP, Dollfus C, Bouallag N, Warszawski J, Buseyne F. Naive T lymphocytes and recent thymic emigrants are associated with HIV-1 disease history in french adolescents and young adults infected in the perinatal period: the ANRS-EP38-IMMIP study. Clin Infect Dis. 2014 Feb;58(4):573-87. doi: 10.1093/cid/cit729. Epub 2013 Nov 18.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut Pasteur

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Grenoble Ecole de Management

title: Naive T Lymphocytes and Recent Thymic Emigrants Are Associated With HIV-1 Disease History in French Adolescents and Young Adults Infected in the Perinatal Period: The ANRS-EP38-IMMIP Study

ReferenceCitation: Avettand-Fenoel V, Blanche S, Le Chenadec J, Scott-Algara D, Dollfus C, Viard JP, Bouallag N, Benmebarek Y, Rivière Y, Warszawski J, Rouzioux C, Buseyne F. Relationships between HIV disease history and blood HIV-1 DNA load in perinatally infected adolescents and young adults: the ANRS-EP38-IMMIP study. J Infect Dis. 2012 May 15;205(10):1520-8. doi: 10.1093/infdis/jis233. Epub 2012 Mar 15.

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

repository_institution: The Pennsylvania State University - CiteSeer X

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

title: Relationships Between HIV Disease History and Blood HIV-1 DNA Load in Perinatally Infected Adolescents and Young Adults: The ANRS-EP38-IMMIP Study

ReferenceCitation: Goetghebuer T, Le Chenadec J, Haelterman E, Galli L, Dollfus C, Thorne C, Judd A, Keiser O, Ramos JT, Levy J, Warszawski J; European Infant Collaboration Group. Short- and long-term immunological and virological outcome in HIV-infected infants according to the age at antiretroviral treatment initiation. Clin Infect Dis. 2012 Mar;54(6):878-81. doi: 10.1093/cid/cir950. Epub 2011 Dec 23.

name: Pediatric Department, CHU St Pierre, Brussels, Belgium

name: Inserm, U822, Le Kremlin-Bicêtre, France

name: Italian Register, Department of Paediatrics, University of Florence, Italy

name: P-HP, Hôpital Trousseau, Service d’Hématologie et d’oncologie pédiatrique, Paris, France

name: MRC Centre of Epidemiology for Child Health, Institute of Child Health, University College London

name: Collaborative HIV Paediatric Study, MRC Clinical Trials Unit, London, United Kingdom

name: Data Center of the Swiss HIV Cohort Study, Lausanne

name: Institute of Social and Preventive Medicine, University of Bern, Switzerland

name: Pediatric Department, Hospital Universitario de Getafe, Madrid, Spain

name: Université Paris-Sud, Faculté de Médecine Paris-Sud, U822, Le Kremlin-Bicêtre, France

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

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

title: Short- and Long-term Immunological and Virological Outcome in HIV-Infected Infants According to the Age at Antiretroviral Treatment Initiation

ReferenceCitation: Judd A; European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC) study group in EuroCoord. Early antiretroviral therapy in HIV-1-infected infants, 1996-2008: treatment response and duration of first-line regimens. AIDS. 2011 Nov 28;25(18):2279-87. doi: 10.1097/QAD.0b013e32834d614c.

title: Early antiretroviral therapy in HIV-1-infected infants, 1996–2008

ReferenceCitation: Pursuing Later Treatment Options II (PLATO II) project team for the Collaboration of Observational HIV Epidemiological Research Europe (COHERE), Castro H, Judd A, Gibb DM, Butler K, Lodwick RK, van Sighem A, Ramos JT, Warsawski J, Thorne C, Noguera-Julian A, Obel N, Costagliola D, Tookey PA, Colin C, Kjaer J, Grarup J, Chene G, Phillips A. Risk of triple-class virological failure in children with HIV: a retrospective cohort study. Lancet. 2011 May 7;377(9777):1580-7. doi: 10.1016/S0140-6736(11)60208-0. Epub 2011 Apr 20.

ReferenceCitation: Dollfus C, Le Chenadec J, Faye A, Blanche S, Briand N, Rouzioux C, Warszawski J. Long-term outcomes in adolescents perinatally infected with HIV-1 and followed up since birth in the French perinatal cohort (EPF/ANRS CO10). Clin Infect Dis. 2010 Jul 15;51(2):214-24. doi: 10.1086/653674.

title: Long‐Term Outcomes in Adolescents Perinatally Infected with HIV‐1 and Followed Up since Birth in the French Perinatal Cohort (EPF/ANRS CO10)

ReferenceCitation: Goetghebuer T, Haelterman E, Le Chenadec J, Dollfus C, Gibb D, Judd A, Green H, Galli L, Ramos JT, Giaquinto C, Warszawski J, Levy J; European Infant Collaboration group. Effect of early antiretroviral therapy on the risk of AIDS/death in HIV-infected infants. AIDS. 2009 Mar 13;23(5):597-604. doi: 10.1097/QAD.0b013e328326ca37.

ReferenceCitation: Collaboration of Observational HIV Epidemiological Research Europe (COHERE) Study Group, Sabin CA, Smith CJ, d'Arminio Monforte A, Battegay M, Gabiano C, Galli L, Geelen S, Gibb D, Guiguet M, Judd A, Leport C, Dabis F, Pantazis N, Porter K, Raffi F, Thorne C, Torti C, Walker S, Warszawski J, Wintergerst U, Chene G, Lundgren J. Response to combination antiretroviral therapy: variation by age. AIDS. 2008 Jul 31;22(12):1463-73. doi: 10.1097/QAD.0b013e3282f88d02.

ReferenceCitation: Warszawski J, Lechenadec J, Faye A, Dollfus C, Firtion G, Meyer L, Douard D, Monpoux F, Tricoire J, Benmebarek Y, Rouzioux C, Blanche S. Long-term nonprogression of HIV infection in children: evaluation of the ANRS prospective French Pediatric Cohort. Clin Infect Dis. 2007 Sep 15;45(6):785-94. Epub 2007 Aug 14.

location_facility: Groupe Hospitalier Cochin Tarnier Port-Royal

location_facility: Centre Hospitalier Général- Hôpital Delafontaine

location_facility: Institut d'Hématologie et Oncologie Pédiatrique


lead_sponsor: UNICANCER

acronym: TopNIVO

location_facility:
Centre Eugène Marquis
Institut Curie Saint Cloud
Centre Antoine Lacassagne
Centre Léon Bérard
Institut de Cancérologie de l'Ouest
Centre Oscar Lambret
Centre Jean Perrin
Institut Jean Godinot
Centre Paul Strauss
Institut Claudius Regaud
Institut de Cancérologie de Lorraine
CHU Bordeaux
Hopital Tenon
ICM Val d'Aurelle
Institut Curie
Centre Georges Francois Leclerc
Gustave Roussy
Centre Francois Baclesse

type: EudraCT Number

source: euctr

title: A Safety Study of Nivolumab in Patients With Recurrent and/or Metastatic Platinum-refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN)

summary:
Recurrent and/or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) are a common clinical situation and although this group of patients has very heterogeneous disease characteristics, they share a dismal prognosis with a median survival time around 6-11 months and a relatively poor quality of life.

Immunotherapy approaches have recently demonstrated clinical efficacy in more than twenty cancer types, including melanoma, renal cell carcinoma, non-small cell lung cancer (NSCLC) and SCCHN. Nivolumab demonstrated significant overall survival benefit as treatment for recurrent SCCHN in a randomized phase III Study CA209141 conducted on a cohort of 361 patients (240 in the nivolumab arm and 121 in the standard therapy arm), presenting this condition and whose disease had progressed within 6 months after platinum-based chemotherapy. In this study, treatment with nivolumab resulted in significantly longer survival than treatment with standard therapy with a median overall survival of 7.5 months vs 5.1 months (p=0.01).

The main objective of the study is to provide additional insight into the frequency of high-grade AEs related to nivolumab and their outcome, and thus supplement the growing safety database of nivolumab-treated recurrent and/or metastatic squamous cell carcinoma of the head and neck patients.


title: A Randomized Trial Testing Early vs Late Onset of EPO Alfa Treatment in Lower Risk MDS With Non RBC Transfusion Dependent Anemia and Without Del 5q

acronym: EPO-PRETAR

summary:
This is an open-label, randomized, multicenter, phase III study

Patients with baseline Hb comprised between 9 and 10.5g/dl will be randomized to receive EPO Alfa 60000 UI/week for at least 12 weeks:

Either at diagnosis Or
at the Hb threshold chosen for RBC transfusions (must be < 9g/dl)

design_allocation: Non-Randomized

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility: Centre Hospitalier Universitaire de STRASBOURG


title: Effects of Perioperative Administration of Dexamethasone on Postoperative Complications and Mortality After Non-cardiac Major Surgery : a Randomized, Multicentre, Double Blind, Study

acronym: PACMAN

summary:
Postoperative complications are major healthcare problems and are associated with a reduced short-term and long-term survival after surgery. Major surgery is associated with a predictable and usually transient Systemic Inflammatory Response (SIRS), depending on the magnitude of the surgical trauma. An excessive SIRS syndrome participates to the development of postoperative organ dysfunction, infection and mortality. Corticosteroids may decrease the postsurgical SIRS in cardiac surgery: in a large multicenter randomized trial, a single intravenous administration of high-dose dexamethasone did not reduce the incidence of a composite endpoint of adverse events but was associated with a reduced incidence of postoperative pulmonary complications and infections and with a reduction in hospital stay. However, a similar study, recently published in the Lancet was negative. Evidences from one meta-analysis, including 11 studies of moderate quality (439 patients in total), suggest that intraoperative administration of corticosteroids during major abdominal surgery decreases postoperative complications, including infectious complications, without significant risk of anastomotic leakage. At present, no large randomized controlled trial has been performed in patients undergoing major non-cardiac surgery. In acute medicine, several lines of evidence have shown that low to moderate doses of corticosteroids decrease the excessive inflammatory response, without inducing immuno suppression. However, despite the widespread use of corticosteroids to reduce postoperative nausea and vomiting and to improve analgesia, concerns continue to be raised about their safety, especially regarding an increased risk of postoperative infection.

We hypothesize that the perioperative administration of glucocorticoids would reduce postoperative morbidity after major non-cardiac surgery through dampening of the inflammatory response. Given the number of surgical patients for whom the question applies, the study is of significant clinical importance

ReferenceCitation: Asehnoune K, Le Moal C, Lebuffe G, Le Penndu M, Josse NC, Boisson M, Lescot T, Faucher M, Jaber S, Godet T, Leone M, Motamed C, David JS, Cinotti R, El Amine Y, Liutkus D, Garot M, Marc A, Le Corre A, Thomasseau A, Jobert A, Flet L, Feuillet F, Pere M, Futier E, Roquilly A; PACMAN study group. Effect of dexamethasone on complications or all cause mortality after major non-cardiac surgery: multicentre, double blind, randomised controlled trial. BMJ. 2021 Jun 2;373:n1162. doi: 10.1136/bmj.n1162.

family: Asehnoune

full_name: Karim Asehnoune

given: Karim

family: Le Moal

full_name: Charlene Le Moal

given: Charlene

family: Lebuffe

full_name: Gilles Lebuffe

family: Le Penndu

full_name: Marguerite Le Penndu

given: Marguerite

family: Josse

full_name: Nolwen Chatel Josse

given: Nolwen Chatel

family: Boisson

full_name: Matthieu Boisson

given: Matthieu

family: Lescot

full_name: Thomas Lescot

given: Thomas

family: Faucher

full_name: Marion Faucher

given: Marion

family: Jaber

full_name: Samir Jaber

given: Samir

family: Godet

full_name: Thomas Godet

family: Leone

full_name: Marc Leone

given: Marc

family: Motamed

full_name: Cyrus Motamed

given: Cyrus

full_name: Jean Stephane David

given: Jean Stephane

family: Cinotti

full_name: Raphael Cinotti

given: Raphael

family: El Amine

full_name: Younes El Amine

given: Younes

family: Liutkus

full_name: Darius Liutkus

given: Darius

family: Garot

full_name: Matthias Garot

given: Matthias

family: Marc

full_name: Antoine Marc

given: Antoine

family: Le Corre

full_name: Anne Le Corre

given: Anne

family: Thomasseau

full_name: Alexandre Thomasseau

given: Alexandre

family: Jobert

full_name: Alexandra Jobert

given: Alexandra

family: Flet

full_name: Laurent Flet

given: Laurent

family: Feuillet

full_name: Fanny Feuillet

given: Fanny

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

ReferenceCitation: Asehnoune K, Futier E, Feuillet F, Roquilly A; PACMAN group. PACMAN trial protocol, Perioperative Administration of Corticotherapy on Morbidity and mortality After Non-cardiac major surgery: a randomised, multicentre, double-blind, superiority study. BMJ Open. 2019 Mar 23;9(3):e021262. doi: 10.1136/bmjopen-2017-021262.

repository_institution: Université de Lille (University Of Lille) - LillOA

repositories:
LillOA (Lille Open Archive)
PubMed Central

location_facility: Hôpital Estaing, CHU de Clermont Ferrand

location_facility: Hôpitaux Universitaires Saint-Louis, Lariboisière, Fernand Widal


title: A Phase II Trial Evaluating Conformational Intensity Modulated Radiotherapy With Concomitant Nivolumab Followed by Nivolumab for Patients With Locally Advanced Non-small Cell Lung Cancer

acronym: AIRING

summary:
Radiotherapy (RT), at a total dose of 60-66 Gy over 6 weeks, combined with platinum-based chemotherapy, is the standard of care for stage III Non-Small Cell Lung Cancers (NSCLC) patients with unresectable or inoperable disease. However, the long-term outcomes are poor, with a 5-year overall survival (OS) rate of 15-35% for stage IIIA, and 5-10% for stage IIIB patients. The recent association of immunotherapy has been proven to improve Progression Free Survival (PFS) and OS for these patients and durvalumab consolidation following chemoradiotherapy (CT-RT) is now the new standard of care.

Compared to older technics (2Dimensions(D) and 3D-RT), intensity-modulated radiotherapy (IMRT) allows for improved organs-at-risk sparing, owing to the high dose conformation to the target volume, thus reducing toxicity rates.

In regard to the recent results of adjuvant immunotherapy, the benefits of concomitant chemotherapy with radiotherapy could be re-evaluated. With the changing landscape in the standard treatment of Local Advanced NSCLC (LA-NSCLC), the reduction in treatment-induced toxicity, while maintaining optimal tumor control, has become a priority, thereby warranting access to adjuvant immunotherapy for these patients. Due to the toxicity of the chemoradiotherapy, a large subset of patients may be unfit for the adjuvant immunotherapy. The use of immunotherapy concomitant to radiotherapy without chemotherapy may be the next step. Nevertheless, as immune cells are highly sensitive to conventional RT doses, the paradigm of the standard irradiation volumes should be reconsidered. In this context, the introduction of IMRT to spare lymphatic tissues and bone marrow deserves evaluation in prospective trials.

A strong body of evidence supports the combination of RT with immunotherapy such as a Programmed cells Death-1 (PD1) inhibitor. Radiation alone can modify the immune response in several ways to allow for synergistic effects when combined with immunotherapy.

The reduction in treatment-induced toxicity while maintaining optimal tumor control has become a priority, thereby warranting access to adjuvant immunotherapy for these patients. In this context, the introduction of IMRT to spare lymphatic tissues and bone marrow deserves evaluation in prospective trials.

The timing of administration of immunotherapy seems to be a major point. Previous data in mice showed that an improved survival benefit with concurrent anti-PD-Ligand1 (PD-L1) and RT versus sequential administration. Moreover, for sequential schedule, an improved survival outcome was found for patients receiving first dose of durvalumab within 14 days of last radiotherapy fraction compared to 14 days or greater.

Furthermore, immunotherapy combined with radiotherapy appears to be safe, without increase of the toxicity.

In summary, there is a strong rationale for testing this new paradigm of accelerated IMRT combined with concurrent and maintenance nivolumab for locally advanced non-small lung cancer, due to:

The unmet medical need for new Standard Of Care (SOC) better tolerated and " as " or " more " effective treatment than CT-RT
The need to decrease radiation-induced toxicity
The limit of CT-RT followed by durvalumab consolidation, leading to a high rate of recurrence within the 18 months (18-month PFS rate of 44.2%)
The strong rationale to combine RT and PD-1 inhibition

It is hypothesized this innovative concept to be safe in the context of this study for the following reasons:

The use of moderate accelerated intensity-modulated radiotherapy (H-IMRT) allows decreasing both the Overall Treatment Time (OTT) and the dose to the organs at risk
The decrease of the OTT (24 fractions instead of 33 fractions) combined with a decrease of the toxicity should represent a potential clinical benefit.

lead_sponsor: Center Eugene Marquis

location_facility: Centre Régional de Lutte Contre le Cancer Eugène Marquis

location_facility: Centre de Lutte Contre le Cancer François Baclesse

location_facility: Centre de Lutte contre le Cancer Oscar Lambret

intervention_type: Combination Product


title: Phase II Study to Assess the Interest of a Sequential Treatment With Gemcitabine/Nab-paclitaxel (GEMBRAX) and Then FOLFIRINOX Followed by Stereotactic Magnetic Resonance-guided Adaptive Radiotherapy in Patients With Locally Advanced Pancreatic Cancer

acronym: GABRINOX-ART

summary:
The aim of this study is to demonstrate the efficacy of intensified and sequential chemotherapy (Gabrinox) comprising Gembrax regimen (Gemcitabine-Abraxane) followed by the Folfirinox regimen (5FU, Oxaliplatin and Irinotecan) in patients with locally advanced pancreatic adenocarcinoma.

The study will also demonstrate the feasibility of combining this intensified chemotherapy with MRI-guided stereotactic radiotherapy in non-progressive patients after the chemotherapy by Gabrinox regimen.

ReferenceCitation: Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5.

ReferenceCitation: Ferlay J, Partensky C, Bray F. More deaths from pancreatic cancer than breast cancer in the EU by 2017. Acta Oncol. 2016 Sep - Oct;55(9-10):1158-1160. doi: 10.1080/0284186X.2016.1197419. Epub 2016 Aug 23.

ReferenceCitation: Conroy T, Hammel P, Hebbar M, Ben Abdelghani M, Wei AC, Raoul JL, Choné L, Francois E, Artru P, Biagi JJ, Lecomte T, Assenat E, Faroux R, Ychou M, Volet J, Sauvanet A, Breysacher G, Di Fiore F, Cripps C, Kavan P, Texereau P, Bouhier-Leporrier K, Khemissa-Akouz F, Legoux JL, Juzyna B, Gourgou S, O'Callaghan CJ, Jouffroy-Zeller C, Rat P, Malka D, Castan F, Bachet JB; Canadian Cancer Trials Group and the Unicancer-GI-PRODIGE Group. FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer. N Engl J Med. 2018 Dec 20;379(25):2395-2406. doi: 10.1056/NEJMoa1809775.

name: From the Institut de Cancérologie de Lorraine and Université de Lorraine (T.C.) and Centre Hospitalier Universitaire (L.C.), Nancy, Hôpital Beaujon and University Paris VII, Clichy (P.H., A.S.), Hôpital Huriez, Lille (M.H.), Centre Paul Strauss, Strasbourg (M.B.A.), Institut Paoli-Calmettes, Marseille (J.-L.R.), Centre Antoine-Lacassagne, Nice (E.F.), Hôpital Jean-Mermoz, Lyon (P.A.), Hôpital Trousseau, Tours (T.L.), Centre Hospitalier Universitaire de Saint-Eloi (E.A.) and Institut du Cancer de...

family: Conroy

full_name: Thierry Conroy

given: Thierry

family: Hammel

full_name: Pascal Hammel

given: Pascal

family: Hebbar

full_name: Mohamed Hebbar

given: Mohamed

family: Ben Abdelghani

full_name: Meher Ben Abdelghani

given: Meher

family: Wei

full_name: Alice C. Wei

given: Alice C.

family: Raoul

full_name: Jean-Luc Raoul

given: Jean-Luc

family: Choné

full_name: Laurence Choné

given: Laurence

family: Francois

full_name: Eric Francois

given: Eric

family: Artru

full_name: Pascal Artru

family: Biagi

full_name: James J. Biagi

given: James J.

family: Lecomte

full_name: Thierry Lecomte

family: Assenat

full_name: Eric Assenat

family: Faroux

full_name: Roger Faroux

given: Roger

family: Ychou

full_name: Marc Ychou

family: Volet

full_name: Julien Volet

given: Julien

family: Sauvanet

full_name: Alain Sauvanet

given: Alain

family: Breysacher

full_name: Gilles Breysacher

given: Gilles

family: Di Fiore

full_name: Frédéric Di Fiore

given: Frédéric

family: Cripps

full_name: Christine Cripps

given: Christine

family: Kavan

full_name: Petr Kavan

given: Petr

family: Texereau

full_name: Patrick Texereau

given: Patrick

family: Bouhier-Leporrier

full_name: Karine Bouhier-Leporrier

given: Karine

family: Khemissa-Akouz

full_name: Faiza Khemissa-Akouz

ReferenceCitation: Conroy T, Desseigne F, Ychou M, Bouché O, Guimbaud R, Bécouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardière C, Bennouna J, Bachet JB, Khemissa-Akouz F, Péré-Vergé D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.

title: FOLFIRINOX versus Gemcitabine for Metastatic Pancreatic Cancer

ReferenceCitation: Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16.

title: Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine

ReferenceCitation: Suker M, Beumer BR, Sadot E, Marthey L, Faris JE, Mellon EA, El-Rayes BF, Wang-Gillam A, Lacy J, Hosein PJ, Moorcraft SY, Conroy T, Hohla F, Allen P, Taieb J, Hong TS, Shridhar R, Chau I, van Eijck CH, Koerkamp BG. FOLFIRINOX for locally advanced pancreatic cancer: a systematic review and patient-level meta-analysis. Lancet Oncol. 2016 Jun;17(6):801-810. doi: 10.1016/S1470-2045(16)00172-8. Epub 2016 May 6. Review.

ReferenceCitation: Philip PA, Lacy J, Portales F, Sobrero A, Pazo-Cid R, Manzano Mozo JL, Kim EJ, Dowden S, Zakari A, Borg C, Terrebonne E, Rivera F, Sastre J, Bathini V, López-Trabada D, Asselah J, Saif MW, Shiansong Li J, Ong TJ, Nydam T, Hammel P. Nab-paclitaxel plus gemcitabine in patients with locally advanced pancreatic cancer (LAPACT): a multicentre, open-label phase 2 study. Lancet Gastroenterol Hepatol. 2020 Mar;5(3):285-294. doi: 10.1016/S2468-1253(19)30327-9. Epub 2020 Jan 14.

journal_name: The Lancet Gastroenterology & Hepatology

ReferenceCitation: Kim YJ, Lee WJ, Woo SM, Kim TH, Han SS, Kim BH, Moon SH, Kim SS, Koh YH, Park SJ, Kim JY, Kim DY, Park JW. Comparison of capecitabine and 5-fluorouracil in chemoradiotherapy for locally advanced pancreatic cancer. Radiat Oncol. 2013 Jul 3;8:160. doi: 10.1186/1748-717X-8-160.

ReferenceCitation: Huang J, Robertson JM, Margolis J, Balaraman S, Gustafson G, Khilanani P, Nadeau L, Jury R, McIntosh B. Long-term results of full-dose gemcitabine with radiation therapy compared to 5-fluorouracil with radiation therapy for locally advanced pancreas cancer. Radiother Oncol. 2011 May;99(2):114-9. doi: 10.1016/j.radonc.2011.05.038. Epub 2011 May 27.

ReferenceCitation: Mukherjee S, Hurt CN, Bridgewater J, Falk S, Cummins S, Wasan H, Crosby T, Jephcott C, Roy R, Radhakrishna G, McDonald A, Ray R, Joseph G, Staffurth J, Abrams RA, Griffiths G, Maughan T. Gemcitabine-based or capecitabine-based chemoradiotherapy for locally advanced pancreatic cancer (SCALOP): a multicentre, randomised, phase 2 trial. Lancet Oncol. 2013 Apr;14(4):317-26. doi: 10.1016/S1470-2045(13)70021-4. Epub 2013 Mar 6.

ReferenceCitation: Yang YF, Cao XH, Bao CE, Wan X. Concurrent radiotherapy with oral fluoropyrimidine versus gemcitabine in locally advanced pancreatic cancer: a systematic review and meta-analysis. Onco Targets Ther. 2015 Nov 9;8:3315-22. doi: 10.2147/OTT.S91292. eCollection 2015.

ReferenceCitation: Hammel P, Huguet F, van Laethem JL, Goldstein D, Glimelius B, Artru P, Borbath I, Bouché O, Shannon J, André T, Mineur L, Chibaudel B, Bonnetain F, Louvet C; LAP07 Trial Group. Effect of Chemoradiotherapy vs Chemotherapy on Survival in Patients With Locally Advanced Pancreatic Cancer Controlled After 4 Months of Gemcitabine With or Without Erlotinib: The LAP07 Randomized Clinical Trial. JAMA. 2016 May 3;315(17):1844-53. doi: 10.1001/jama.2016.4324.

name: Department of Digestive Oncology, Beaujon Hospital (AP-HP), Clichy, France

name: Department of Radiotherapy, Tenon Hospital (AP-HP), Paris, France

name: Department of Gastroenterology, Erasme University Hospital, Brussels, Belgium

name: Department of Medical Oncology, Prince of Wales Hospital, Sydney, Australia5Australasian Gastrointestinal Trials Group (AGITG), Camperdown, Australia6Prince of Wales Clinical School, University of New South Wales, Sydney, Australia

name: Department of Radiology, Oncology, and Radiation Science, University of Uppsala, Uppsala, Sweden

name: Department of Gastroenterology, Jean Mermoz Hospital, Lyon, France

name: Department of Gastroenterology, Saint-Luc University Clinics, Brussels, Belgium

name: Department of Gastroenterology, Robert Debré Hospital, Reims, France

name: Australasian Gastrointestinal Trials Group (AGITG), Camperdown, Australia6Prince of Wales Clinical School, University of New South Wales, Sydney, Australia11Department of Medical Oncology, Nepean Hospital NSW, Sydney, Australia

name: Department of Medical Oncology, Saint-Antoine Hospital (AP-HP), Paris, France

name: Department of Radiotherapy and Medical Oncology, Sainte-Catherine Institute, Avignon, France

name: Department of Medical Oncology, Franco-British Hospital Institute, Levallois-Perret, France15Oncology Multidisciplinary Research Group (GERCOR), Paris, France

name: Department of Methodology and Quality of Life in Oncology, Hospital Minjoz, Besançon, France

name: Department of Medical Oncology, Institute Mutualiste Montsouris, Paris, France

ReferenceCitation: Petrelli F, Comito T, Ghidini A, Torri V, Scorsetti M, Barni S. Stereotactic Body Radiation Therapy for Locally Advanced Pancreatic Cancer: A Systematic Review and Pooled Analysis of 19 Trials. Int J Radiat Oncol Biol Phys. 2017 Feb 1;97(2):313-322. doi: 10.1016/j.ijrobp.2016.10.030. Epub 2016 Oct 24. Review.

ReferenceCitation: Reyngold M, Parikh P, Crane CH. Ablative radiation therapy for locally advanced pancreatic cancer: techniques and results. Radiat Oncol. 2019 Jun 6;14(1):95. doi: 10.1186/s13014-019-1309-x. Review.

ReferenceCitation: Crane CH, O'Reilly EM. Ablative Radiotherapy Doses for Locally Advanced: Pancreatic Cancer (LAPC). Cancer J. 2017 Nov/Dec;23(6):350-354. doi: 10.1097/PPO.0000000000000292. Review.

ReferenceCitation: Acharya S, Fischer-Valuck BW, Kashani R, Parikh P, Yang D, Zhao T, Green O, Wooten O, Li HH, Hu Y, Rodriguez V, Olsen L, Robinson C, Michalski J, Mutic S, Olsen J. Online Magnetic Resonance Image Guided Adaptive Radiation Therapy: First Clinical Applications. Int J Radiat Oncol Biol Phys. 2016 Feb 1;94(2):394-403. doi: 10.1016/j.ijrobp.2015.10.015. Epub 2015 Oct 17. Erratum in: Int J Radiat Oncol Biol Phys. 2016 Sep 1;96(1):243.

ReferenceCitation: Fischer-Valuck BW, Henke L, Green O, Kashani R, Acharya S, Bradley JD, Robinson CG, Thomas M, Zoberi I, Thorstad W, Gay H, Huang J, Roach M, Rodriguez V, Santanam L, Li H, Li H, Contreras J, Mazur T, Hallahan D, Olsen JR, Parikh P, Mutic S, Michalski J. Two-and-a-half-year clinical experience with the world's first magnetic resonance image guided radiation therapy system. Adv Radiat Oncol. 2017 Jun 1;2(3):485-493. doi: 10.1016/j.adro.2017.05.006. eCollection 2017 Jul-Sep.

ReferenceCitation: Henke LE, Contreras JA, Green OL, Cai B, Kim H, Roach MC, Olsen JR, Fischer-Valuck B, Mullen DF, Kashani R, Thomas MA, Huang J, Zoberi I, Yang D, Rodriguez V, Bradley JD, Robinson CG, Parikh P, Mutic S, Michalski J. Magnetic Resonance Image-Guided Radiotherapy (MRIgRT): A 4.5-Year Clinical Experience. Clin Oncol (R Coll Radiol). 2018 Nov;30(11):720-727. doi: 10.1016/j.clon.2018.08.010. Epub 2018 Sep 7.

ReferenceCitation: Henke L, Kashani R, Robinson C, Curcuru A, DeWees T, Bradley J, Green O, Michalski J, Mutic S, Parikh P, Olsen J. Phase I trial of stereotactic MR-guided online adaptive radiation therapy (SMART) for the treatment of oligometastatic or unresectable primary malignancies of the abdomen. Radiother Oncol. 2018 Mar;126(3):519-526. doi: 10.1016/j.radonc.2017.11.032. Epub 2017 Dec 23.

ReferenceCitation: Boldrini L, Cusumano D, Cellini F, Azario L, Mattiucci GC, Valentini V. Online adaptive magnetic resonance guided radiotherapy for pancreatic cancer: state of the art, pearls and pitfalls. Radiat Oncol. 2019 Apr 29;14(1):71. doi: 10.1186/s13014-019-1275-3. Review.

ReferenceCitation: Bohoudi O, Bruynzeel AME, Meijerink MR, Senan S, Slotman BJ, Palacios MA, Lagerwaard FJ. Identification of patients with locally advanced pancreatic cancer benefitting from plan adaptation in MR-guided radiation therapy. Radiother Oncol. 2019 Mar;132:16-22. doi: 10.1016/j.radonc.2018.11.019. Epub 2018 Dec 20.

ReferenceCitation: El-Bared N, Portelance L, Spieler BO, Kwon D, Padgett KR, Brown KM, Mellon EA. Dosimetric Benefits and Practical Pitfalls of Daily Online Adaptive MRI-Guided Stereotactic Radiation Therapy for Pancreatic Cancer. Pract Radiat Oncol. 2019 Jan;9(1):e46-e54. doi: 10.1016/j.prro.2018.08.010. Epub 2018 Aug 25.

ReferenceCitation: Luterstein E, Cao M, Lamb J, Raldow AC, Low DA, Steinberg ML, Lee P. Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) for Locally Advanced Pancreatic Cancer: A Promising Approach. Cureus. 2018 Mar 14;10(3):e2324. doi: 10.7759/cureus.2324.

ReferenceCitation: Olberg S, Green O, Cai B, Yang D, Rodriguez V, Zhang H, Kim JS, Parikh PJ, Mutic S, Park JC. Optimization of treatment planning workflow and tumor coverage during daily adaptive magnetic resonance image guided radiation therapy (MR-IGRT) of pancreatic cancer. Radiat Oncol. 2018 Mar 24;13(1):51. doi: 10.1186/s13014-018-1000-7.

ReferenceCitation: Tyran M, Jiang N, Cao M, Raldow A, Lamb JM, Low D, Luterstein E, Steinberg ML, Lee P. Retrospective evaluation of decision-making for pancreatic stereotactic MR-guided adaptive radiotherapy. Radiother Oncol. 2018 Nov;129(2):319-325. doi: 10.1016/j.radonc.2018.08.009. Epub 2018 Aug 30.

ReferenceCitation: Rudra S, Jiang N, Rosenberg SA, Olsen JR, Roach MC, Wan L, Portelance L, Mellon EA, Bruynzeel A, Lagerwaard F, Bassetti MF, Parikh PJ, Lee PP. Using adaptive magnetic resonance image-guided radiation therapy for treatment of inoperable pancreatic cancer. Cancer Med. 2019 May;8(5):2123-2132. doi: 10.1002/cam4.2100. Epub 2019 Apr 1.

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

location_facility: Institut régional du Cancer de Montpellier


title: Evaluation of the Impact of Wearing a Millimetre Wave Bracelet for 3 Months on the Frequency in Number of Days of Migraines in Patients With Episodic Migraines Without Aura

acronym: MISTIC

summary:
Migraine is a neurovascular disease whose prevalence is estimated at almost 20% of the adult population. Currently, there is no treatment for migraine.

Millimeter stimulation of the wrist subcutaneous receptors allows the release of endorphin in the brain.

MISTIC is a prospective, controlled, multicenter, double-blind, randomized study in which the research team are investigating whether millimeter stimulation of subcutaneous wrist receptors reduces the frequency of migraine crisis.

lead_sponsor: Remedee SA

location_facility:
CH Fondation Rotschild
CHU Grenoble Alpes
CH Voiron
Cabinet Saint Ismier
Cabinet Neuralpes


title: Pre-operative Carriage of Respiratory VIRUSes, and Acute Respiratory Distress Syndrome After Heart Surgery - VIRUS-ATTAC

acronym: VIRUS-ATTAC

summary: The main objective of our study is to determine whether asymptomatic influenza virus carriage is associated with an increased risk of post-operative Acute Respiratory Distress Syndrome (ARDS) after cardiac surgery. Cardiac surgery patients are particularly at risk of developing ARDS with an estimated incidence of 5-10% based on the most recent data.

primary_purpose: Prevention

lead_sponsor: Rennes University Hospital

location_facility:
CHU Poitiers
APHP La Pitié-Salpétrière
CHU Nantes
APHP Henri Mondor
CHU Rennes

intervention_type: Diagnostic Test


title: The "Self Evaluation of Food Intake" (SEFI) as a Screening Test for Hospital Malnutrition in Children Over 10 Years

acronym: SEFI

summary: The goal is to find a simple tool that can be used by medical and paramedical staff and that is reliable to identify children at risk for malnutrition.

location_facility: APHP Trousseau Paris University Hospital


title: ICITRU : Randomized Trial of Immunonutrition With L-citrulline in Patients Hospitalized in Intensive Care for Sepsis or Septic Shock

acronym: ICITRU

summary:
Immunonutrition in intensive care has not yet demonstrated a beneficial effect on organ failure, the acquisition of nosocomial infections, or mortality. It did not correct for acquired immunosuppression in intensive care patients. Despite numerous methodological problems (use of several pharmaconutrients, very heterogeneous set of patients) and the absence of clinical data, deleterious effects have been attributed to immunonutrition in intensive care, in particular in septic patients and patients in intensive care . Arginine (ARG) is a semi-essential amino acid involved in many immunological mechanisms. It is synthesized in sufficient quantity under normal conditions but quickly becomes insufficient under catabolic conditions such as in severe sepsis. Arginine is not only the precursor of nitrogen monoxide (NO) but also an essential substrate for numerous enzymatic reactions which participate in the maintenance of immune homeostasis, in particular T lymphocyte function. Depletion of the cellular medium in arginine will induce an abnormality in the metabolism of immune cells responsible for a dysfunction of these cells (lymphopenia linked to early apoptosis) and thus expose patients to organ failure and nosocomial infections.

It has been found that hypoargininemia in intensive care patients is associated with the persistence of organ dysfunction (SOFA score), the occurrence of nosocomial infections and mortality. Also, it has been demonstrated that in these patients, enteral administration of ARG was not deleterious and increased ornithine synthesis, suggesting a preferential use of ARG via the arginases route, without significant increase in argininaemia or effect on immune functions. L-citrulline (CIT), an endogenous precursor of ARG, constitutes an interesting alternative for increasing the availability of ARG. Sponsor recent data demonstrate that the administration of CIT in intensive care is not deleterious and that it very significantly reduces mortality in an animal model of sepsis, corrects hypoargininemia, with convincing data on immunological parameters such as lymphopenia, which is associated with mortality, organ dysfunction and the occurrence of nosocomial infections. The availability of ARG directly impacts the mitochondrial metabolism of T lymphocytes and their function. Our hypothesis is therefore that CIT supplementation is more effective than administration of ARG in correcting hypoargininemia, reducing lymphocyte dysfunction, correcting immunosuppression and organ dysfunction in septic patients admitted to intensive care.

location_facility: Rennes University Hospital - Surgical ICU

location_facility: Rennes University Hospital - Medical ICU


title: Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Rectal Endometriosis

summary:
Rectal endometriosis (RE) induces lesions associated with painful symptoms that can alter quality of life. High Intensity Focused Ultrasound (HIFU) is a non-invasive ablative procedure using a high-intensity ultrasound probe to induce tissue devitalization using acoustic cavitation and thermal ablation. Focal One® is a transrectal HIFU device, which is validated to treat prostatic cancer.

The primary objective of this clinical investigation is to evaluate the safety of the HIFU treatment of rectal endometriosis with Focal One® HIFU device.

lead_sponsor: EDAP TMS S.A.

location_facility:
Clinique de Gynécologie
CHU de Angers
Hôpital BICETRE
Hopital de la Croix Rousse
Clinique Tivoli-Ducos


title: Distal Pancreatectomy, Minimally Invasive or Open, for Malignancy (DIPLOMA): a Pan-European, Randomized Controlled, Multicenter, Patient Blinded, Non-inferiority Trial

acronym: DIPLOMA

summary:
Objective: To compare MIDP with ODP regarding radical resection rate for pancreatic ductal adenocarcinoma (PDAC) in the pancreatic body or tail.

Study design: A pan-European, randomized controlled, multicenter, patient-blinded non-inferiority trial. This protocol was designed according to the SPIRIT guidelines1. Pathologists judging the primary endpoint will be blinded for the surgical approach (MIDP vs ODP). A blinded adjudication committee will assess all endpoints.

Study population: Two groups of 129 patients (258 in total) with an indication for elective distal pancreatectomy with splenectomy because of proven or highly suspected PDAC.

Intervention: Minimally invasive distal pancreatectomy (either laparoscopic or robot-assisted)

Control: Open distal pancreatectomy

primary_purpose: Other

lead_sponsor: University Hospital, Montpellier

location_facility:
Centre Hospitalier Orléans
Hôpital Paul Brousse
CHU Saint Eloi - Montpellier
Hôpital Beaujon - APHP
Institut Mutualiste Montsouris

intervention_type: Procedure


title: ExtraCorporeal Life Support (ECLS) Versus IMPELLA™ Pump as Bridge to Left Ventricular Assist Device

acronym: ECI-BLAD

summary: In this retrospective observational multicenter study the authors tested the hypothesis that the use of IMPELLA™ pump as bridge to bridge, by giving the opportunity of active rehabilitation, should improve patient's outcomes after the implantation of Left Ventricular Assist Device (LVAD).

time_perspective: Retrospective

lead_sponsor: University Hospital, Bordeaux

location_facility:
CHU de Dijon-Bourgoigne
CHU de Bordeaux
CHU de Montpellier
CHU de Rennes
CHU de Toulouse


title: Intra-nodal Injection of Gentamicin for the Treatment of Suppurated Cat Scratch Disease's Lymphadenitis: A Randomized Controlled Study

acronym: BIGG

summary: To compare effect of intra-nodal injection of gentamicin versus placebo on the outcome at 28 days of suppurated cat scratch disease's (CSD) lymphadenitis treated by oral azithromycin.

lead_sponsor: University Hospital, Toulouse

location_facility:
Amiens-Picardie Hospital
Microbiology Laboratory
Limoges University Hospital
Angers Hospital
Hospices Civils Lyon
Auch Hospital
Vendée Hospital
Bordeaux University Hospital
Tarbes Hospital
Albi Hospital
Cahors Hospital
Saint-Brieuc Hospital
Montauban Hospital
Nîmes University Hospital
Rodez Hospital
Montpellier University Hospital
Castres Hospital
Rennes Hospital
Pau Hospital
Perpignan Hospital
Saint-Nazaire Hospital


title: Safety And Effectiveness Evaluation Of COBRA PzF™ Coronary Stent System: A French Observational Postmarketing Registry

acronym: eCOBRA

summary: A multi-center, prospective, consecutive enrolled, observational registry. The population being studied includes all patients undergoing treatment of "de novo" lesions in native coronary vessels, saphenous vein graft and/or arterial bypass conduits with the COBRA PzF coronary stent system. The registry will primarily assess the rate of MACE (cardiac death, myocardial infarction and clinically driven target lesion revascularization.

lead_sponsor: CeloNova BioSciences, Inc.

location_facility:
Clinique Axium
Clinique St Hilaire
Clinique Cardiologie
Centre Hospitalier
Clinique du Millenaire
Clinique St-Martin
Polyclinique de Courlancy
Infirmerie Protestante
SCM Angioscan
Clinique des Domes
Clinique La Casamance
Clinique La Fourcade
Clinique Mutualiste
Clinique du Pont de Chaume
GCS Cardio


title: Collection of Additional Data Followed the Study "A Phase III Study of Velcade (Bortezomib) Thalidomide Dexaméthasone (VTD) Versus Velcade (Bortezomib) Cyclophosphamide Dexaméthasone (VCD) as an Induction Treatment Prior to Autologous Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma"

summary: Collection of retrospective additional data (survival, biological, disease response data) following the study IFM 2013-04.

status: Unknown status

lead_sponsor: Nantes University Hospital

location_facility: Centre Hospitalier de la région d'Annecy

location_facility: Centre Hospitalier intercommunale Meulan les mureaux


location_facility: Institut Daniel Hollard - Groupe Hospitalier Mutualiste de Grenoble

location_facility: Institut de Cancérologie de l'Ouest - Site René Gauducheau

location_facility: Institut de Cancérologie de l'Ouest - Site Paul Papin

location_facility: Centre d'Oncologie radiothérapie de Macon

location_facility: Centre Hospitalier Départemental de Vendée

location_facility: CARIO - Centre Armoricain Radiothérapie Imagerie Médicale et Oncologi

location_facility: Centre Hospitalier de Tours - Hopital Bretonneau

location_facility: Centre ONCOGARD - Institut de Cancérologie du Gard

location_facility: Centre de radiothérapie et d'oncologie médicale LE-CROME

title: Randomized, Open Label, Multicentric Phase III Trial to Evaluate the Safety and Efficacy of Palbociclib in Combination With HT Driven by ctDNA ESR1 Mutation Monitoring in ER+, HER2-negative Metastatic Breast Cancer Patients

summary: This study is a randomized, open-label, multicentric, phase III trial conducted in patients receiving aromatase inhibitor and palbociclib as first line therapy for estrogen receptor (ER)-positive HER2-negative metastatic breast cancer and which aims to evaluate, at the onset of ESR1 mutations in circulating tumor DNA, the efficacy of a change of the hormone therapy (aromatase inhibitor (AI) changed to fulvestrant) combined to palbociclib, together with the safety of hormone therapy and palbociclib combination in the overall population.


title: Evaluation of a Transfusion Therapy Using Whole Blood Versus Fractionated Blood Products in the Management of Coagulopathy in Patients Admitted to Hospital for Acute Traumatic Hemorrhage

acronym: T-STORHM

summary:
The prognosis of traumatized hemorrhages is correlated with the nature of transfusion therapy: a 50% reduction in mortality for an early and massive supply of plasma, and 20% for an early and massive supply of platelets. However, this strategy encounters logistical difficulties, particularly in a context of collective emergency (attacks). The use of whole blood, widely documented by the Armed Forces, improves the availability of plasma and platelets, and simplifies handling by the various actors in the chain.

T-STORHM is a randomized, controlled, parallel clinical trial.This study tests non-inferiority of whole blood transfusion therapy in the management of coagulopathy in patients with acute traumatic hemorrhage.

ReferenceCitation: Spinella PC. Zero preventable deaths after traumatic injury: An achievable goal. J Trauma Acute Care Surg. 2017 Jun;82(6S Suppl 1):S2-S8. doi: 10.1097/TA.0000000000001425.

ReferenceCitation: Bhangu A, Nepogodiev D, Doughty H, Bowley DM. Meta-analysis of plasma to red blood cell ratios and mortality in massive blood transfusions for trauma. Injury. 2013 Dec;44(12):1693-9. doi: 10.1016/j.injury.2012.07.193. Epub 2012 Sep 25. Review.

ReferenceCitation: Johansson PI, Oliveri RS, Ostrowski SR. Hemostatic resuscitation with plasma and platelets in trauma. J Emerg Trauma Shock. 2012 Apr;5(2):120-5. doi: 10.4103/0974-2700.96479.

ReferenceCitation: Cap A, Hunt B. Acute traumatic coagulopathy. Curr Opin Crit Care. 2014 Dec;20(6):638-45. doi: 10.1097/MCC.0000000000000158. Review.

ReferenceCitation: Cap AP, Pidcoke HF, Spinella P, Strandenes G, Borgman MA, Schreiber M, Holcomb J, Tien HC, Beckett AN, Doughty H, Woolley T, Rappold J, Ward K, Reade M, Prat N, Ausset S, Kheirabadi B, Benov A, Griffin EP, Corley JB, Simon CD, Fahie R, Jenkins D, Eastridge BJ, Stockinger Z. Damage Control Resuscitation. Mil Med. 2018 Sep 1;183(suppl_2):36-43. doi: 10.1093/milmed/usy112.

ReferenceCitation: Spahn DR, Bouillon B, Cerny V, Duranteau J, Filipescu D, Hunt BJ, Komadina R, Maegele M, Nardi G, Riddez L, Samama CM, Vincent JL, Rossaint R. The European guideline on management of major bleeding and coagulopathy following trauma: fifth edition. Crit Care. 2019 Mar 27;23(1):98. doi: 10.1186/s13054-019-2347-3.

ReferenceCitation: Godier A, Bacus M, Kipnis E, Tavernier B, Guidat A, Rauch A, Drumez E, Susen S, Garrigue-Huet D. Compliance with evidence-based clinical management guidelines in bleeding trauma patients. Br J Anaesth. 2016 Nov;117(5):592-600.

ReferenceCitation: Stanworth SJ, Davenport R, Curry N, Seeney F, Eaglestone S, Edwards A, Martin K, Allard S, Woodford M, Lecky FE, Brohi K. Mortality from trauma haemorrhage and opportunities for improvement in transfusion practice. Br J Surg. 2016 Mar;103(4):357-65. doi: 10.1002/bjs.10052. Epub 2016 Feb 3.

ReferenceCitation: Carli P, Pons F, Levraut J, Millet B, Tourtier JP, Ludes B, Lafont A, Riou B. The French emergency medical services after the Paris and Nice terrorist attacks: what have we learnt? Lancet. 2017 Dec 16;390(10113):2735-2738. doi: 10.1016/S0140-6736(17)31590-8. Epub 2017 Jul 25.

ReferenceCitation: Eastridge BJ, Mabry RL, Seguin P, Cantrell J, Tops T, Uribe P, Mallett O, Zubko T, Oetjen-Gerdes L, Rasmussen TE, Butler FK, Kotwal RS, Holcomb JB, Wade C, Champion H, Lawnick M, Moores L, Blackbourne LH. Death on the battlefield (2001-2011): implications for the future of combat casualty care. J Trauma Acute Care Surg. 2012 Dec;73(6 Suppl 5):S431-7. doi: 10.1097/TA.0b013e3182755dcc. Erratum in: J Trauma Acute Care Surg. 2013 Feb;74(2):706. Kotwal, Russell S [corrected to Kotwal, Russ S].

ReferenceCitation: Eastridge BJ, Hardin M, Cantrell J, Oetjen-Gerdes L, Zubko T, Mallak C, Wade CE, Simmons J, Mace J, Mabry R, Bolenbaucher R, Blackbourne LH. Died of wounds on the battlefield: causation and implications for improving combat casualty care. J Trauma. 2011 Jul;71(1 Suppl):S4-8. doi: 10.1097/TA.0b013e318221147b.

ReferenceCitation: Glasgow S, Davenport R, Perkins Z, Tai N, Brohi K. A comprehensive review of blood product use in civilian mass casualty events. J Trauma Acute Care Surg. 2013 Sep;75(3):468-74. doi: 10.1097/TA.0b013e318298efb9. Review.

ReferenceCitation: Doughty H, Glasgow S, Kristoffersen E. Mass casualty events: blood transfusion emergency preparedness across the continuum of care. Transfusion. 2016 Apr;56 Suppl 2:S208-16. doi: 10.1111/trf.13488. Review.

ReferenceCitation: Glasgow SM, Allard S, Rackham R, Doughty H. Going for gold: blood planning for the London 2012 Olympic Games. Transfus Med. 2014 Jun;24(3):145-53. doi: 10.1111/tme.12116. Epub 2014 Apr 18. Review.

ReferenceCitation: Glasgow SM, Allard S, Doughty H, Spreadborough P, Watkins E. Blood and bombs: the demand and use of blood following the London Bombings of 7 July 2005--a retrospective review. Transfus Med. 2012 Aug;22(4):244-50. doi: 10.1111/j.1365-3148.2012.01173.x. Review.

ReferenceCitation: Radwan ZA, Bai Y, Matijevic N, del Junco DJ, McCarthy JJ, Wade CE, Holcomb JB, Cotton BA. An emergency department thawed plasma protocol for severely injured patients. JAMA Surg. 2013 Feb;148(2):170-5. doi: 10.1001/jamasurgery.2013.414.

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.

family: de Biasi

full_name: Andreas R. de Biasi

given: Andreas R.

family: Stansbury

full_name: Lynn G. Stansbury

given: Lynn G.

family: Dutton

full_name: Richard P. Dutton

given: Richard P.

family: Stein

full_name: Deborah M. Stein

given: Deborah M.

family: Scalea

full_name: Thomas M. Scalea

given: Thomas M.

family: Hess

full_name: John R. Hess

given: John R.

journal_name: Transfusion

repository_institution: PubMed Central - Europe PMC

version: acceptedVersion

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Blood product use in trauma resuscitation: plasma deficit versus plasma ratio as predictors of mortality in trauma (CME)

ReferenceCitation: Cardenas JC, Zhang X, Fox EE, Cotton BA, Hess JR, Schreiber MA, Wade CE, Holcomb JB; PROPPR Study Group. Platelet transfusions improve hemostasis and survival in a substudy of the prospective, randomized PROPPR trial. Blood Adv. 2018 Jul 24;2(14):1696-1704. doi: 10.1182/bloodadvances.2018017699.

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.

name: Center for Translational Injury Research, Division of Acute Care Surgery, Department of Surgery, Medical School, University of Texas Health Science Center, Houston

family: Holcomb

full_name: John B. Holcomb

given: John B.

name: Division of Biostatistics, School of Public Health, University of Texas Health Science Center, Houston

family: Tilley

full_name: Barbara C. Tilley

given: Barbara C.

family: Baraniuk

full_name: Sarah Baraniuk

given: Sarah

family: Fox

full_name: Erin E. Fox

given: Erin E.

family: Wade

full_name: Charles E. Wade

given: Charles E.

family: Podbielski

full_name: Jeanette M. Podbielski

given: Jeanette M.

family: del Junco

full_name: Deborah J. del Junco

given: Deborah J.

name: Division of Trauma and Critical Care, Department of Surgery, Medical College of Wisconsin, Milwaukee22Dr Brasel is now with the Division of Trauma, Critical Care and Acute Care Surgery, School of Medicine, Oregon Health & Science University, Portland

name: Division of Trauma and Critical Care, Department of Surgery, School of Medicine, University of Washington, Seattle

name: Division of General Surgery, Department of Surgery, School of Medicine, University of California, San Francisco

name: Division of Trauma and Surgical Critical Care, Department of Surgery, College of Medicine, University of Tennessee Health Science Center, Memphis

name: Division of Trauma and Critical Care, University of Southern California, Los Angeles

name: Division of Trauma, Burns and Surgical Critical Care, Department of Surgery, School of Medicine, University of Alabama, Birmingham

name: Division of Trauma/Critical Care, Department of Surgery, College of Medicine, University of Cincinnati, Cincinnati, Ohio23Dr Muskat is now with the Division of General Surgery, Department of Surgery, School of Medicine, University of California, San Franc

name: Division of Trauma, Critical Care and Emergency Surgery, Department of Surgery, University of Arizona, Tucson

name: Trauma and Acute Care Surgery, St Michael’s Hospital, University of Toronto, Toronto, Ontario, Canada

name: Division of Trauma/Critical Care, Department of Surgery, College of Medicine, University of Cincinnati, Cincinnati, Ohio

name: R. Adams Cowley Shock Trauma Center, Program in Trauma, University of Maryland School of Medicine, Baltimore

name: Division of Trauma, Critical Care and Acute Care Surgery, School of Medicine, Oregon Health & Science University, Portland

name: Sunnybrook Research Institute, Department of Clinical Pathology, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

name: Department of Laboratory Medicine, School of Medicine, University of Washington, Seattle

name: Department of Emergency Medicine, College of Medicine, University of Cincinnati, Cincinnati, Ohio

name: Division of Critical Care and Perioperative Medicine, Department of Anesthesiology, School of Medicine, University of Alabama, Birmingham

name: American College of Surgeons, Chicago, Illinois

name: Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland

name: Department of Biostatistics, School of Public Health, University of Washington, Seattle

name: Department of Biostatistics, School of Public Health, University of Washington, Seattle21Department of Environmental and Occupational Health Sciences, School of Public Health, University of Washington, Seattle

title: 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

ReferenceCitation: Holcomb JB, del Junco DJ, Fox EE, Wade CE, Cohen MJ, Schreiber MA, Alarcon LH, Bai Y, Brasel KJ, Bulger EM, Cotton BA, Matijevic N, Muskat P, Myers JG, Phelan HA, White CE, Zhang J, Rahbar MH; PROMMTT Study Group. The prospective, observational, multicenter, major trauma transfusion (PROMMTT) study: comparative effectiveness of a time-varying treatment with competing risks. JAMA Surg. 2013 Feb;148(2):127-36.

ReferenceCitation: Cap AP, Spinella PC, Borgman MA, Blackbourne LH, Perkins JG. Timing and location of blood product transfusion and outcomes in massively transfused combat casualties. J Trauma Acute Care Surg. 2012 Aug;73(2 Suppl 1):S89-94. doi: 10.1097/TA.0b013e318260625a.

ReferenceCitation: Fox EE, Holcomb JB, Wade CE, Bulger EM, Tilley BC; PROPPR Study Group. Earlier Endpoints are Required for Hemorrhagic Shock Trials Among Severely Injured Patients. Shock. 2017 May;47(5):567-573. doi: 10.1097/SHK.0000000000000788.

ReferenceCitation: Novak DJ, Bai Y, Cooke RK, Marques MB, Fontaine MJ, Gottschall JL, Carey PM, Scanlan RM, Fiebig EW, Shulman IA, Nelson JM, Flax S, Duncan V, Daniel-Johnson JA, Callum JL, Holcomb JB, Fox EE, Baraniuk S, Tilley BC, Schreiber MA, Inaba K, Rizoli S, Podbielski JM, Cotton BA, Hess JR; PROPPR Study Group. Making thawed universal donor plasma available rapidly for massively bleeding trauma patients: experience from the Pragmatic, Randomized Optimal Platelets and Plasma Ratios (PROPPR) trial. Transfusion. 2015 Jun;55(6):1331-9. doi: 10.1111/trf.13098. Epub 2015 Mar 30.

ReferenceCitation: Daban JL, Kerleguer A, Clavier B, Salliol A, Ausset S. [Fresh whole blood transfusion for war surgery: the experience of the Kabul French combat support hospital from 2006 to 2009]. Ann Fr Anesth Reanim. 2012 Nov;31(11):850-6. doi: 10.1016/j.annfar.2012.07.014. Epub 2012 Sep 1. French.

ReferenceCitation: Esnault P, Cungi PJ, Romanat PE, D'Aranda E, Cotte J, Bordes J, Vichard A, Aguillon P, Sailliol A, Meaudre E. [Blood transfusion on battlefield. The Kabul hospital experience]. Ann Fr Anesth Reanim. 2013 Oct;32(10):670-5. doi: 10.1016/j.annfar.2013.06.007. Epub 2013 Aug 13. French.

ReferenceCitation: Ausset S, Meaudre E, Kaiser E, Sailliol A, Hugard L, Jeandel P. [Acute traumatic haemorrhagic shock and transfusion: the French army policy]. Ann Fr Anesth Reanim. 2009 Jul-Aug;28(7-8):707-9. doi: 10.1016/j.annfar.2009.05.011. Epub 2009 Jul 3. French.

ReferenceCitation: McGuigan R, Spinella PC, Beekley A, Sebesta J, Perkins J, Grathwohl K, Azarow K. Pediatric trauma: experience of a combat support hospital in Iraq. J Pediatr Surg. 2007 Jan;42(1):207-10.

ReferenceCitation: Sailliol A, Clavier B, Cap A, Ausset S. [French European military haemovigilance guidelines]. Transfus Clin Biol. 2010 Dec;17(5-6):315-7. doi: 10.1016/j.tracli.2010.09.001. Epub 2010 Nov 3. French.

ReferenceCitation: Nair PM, Pidcoke HF, Cap AP, Ramasubramanian AK. Effect of cold storage on shear-induced platelet aggregation and clot strength. J Trauma Acute Care Surg. 2014 Sep;77(3 Suppl 2):S88-93. doi: 10.1097/TA.0000000000000327.

ReferenceCitation: Pidcoke HF, Spinella PC, Ramasubramanian AK, Strandenes G, Hervig T, Ness PM, Cap AP. Refrigerated platelets for the treatment of acute bleeding: a review of the literature and reexamination of current standards. Shock. 2014 May;41 Suppl 1:51-3. doi: 10.1097/SHK.0000000000000078. Review.

ReferenceCitation: Nair PM, Pandya SG, Dallo SF, Reddoch KM, Montgomery RK, Pidcoke HF, Cap AP, Ramasubramanian AK. Platelets stored at 4°C contribute to superior clot properties compared to current standard-of-care through fibrin-crosslinking. Br J Haematol. 2017 Jul;178(1):119-129. doi: 10.1111/bjh.14751. Epub 2017 Jun 4.

ReferenceCitation: Bahr MP, Yazer MH, Triulzi DJ, Collins RA. Whole blood for the acutely haemorrhaging civilian trauma patient: a novel idea or rediscovery? Transfus Med. 2016 Dec;26(6):406-414. doi: 10.1111/tme.12329. Epub 2016 Jun 29. Review.

ReferenceCitation: Cotton BA, Podbielski J, Camp E, Welch T, del Junco D, Bai Y, Hobbs R, Scroggins J, Hartwell B, Kozar RA, Wade CE, Holcomb JB; Early Whole Blood Investigators. A randomized controlled pilot trial of modified whole blood versus component therapy in severely injured patients requiring large volume transfusions. Ann Surg. 2013 Oct;258(4):527-32; discussion 532-3. doi: 10.1097/SLA.0b013e3182a4ffa0. Erratum in: Ann Surg. 2014 Jul;260(1):178.

ReferenceCitation: Jenkins D, Stubbs J, Williams S, Berns K, Zielinski M, Strandenes G, Zietlow S. Implementation and execution of civilian remote damage control resuscitation programs. Shock. 2014 May;41 Suppl 1:84-9. doi: 10.1097/SHK.0000000000000133.

ReferenceCitation: Stubbs JR, Zielinski MD, Jenkins D. The state of the science of whole blood: lessons learned at Mayo Clinic. Transfusion. 2016 Apr;56 Suppl 2:S173-81. doi: 10.1111/trf.13501.

ReferenceCitation: Yazer MH, Jackson B, Sperry JL, Alarcon L, Triulzi DJ, Murdock AD. Initial safety and feasibility of cold-stored uncrossmatched whole blood transfusion in civilian trauma patients. J Trauma Acute Care Surg. 2016 Jul;81(1):21-6. doi: 10.1097/TA.0000000000001100.

ReferenceCitation: Seheult JN, Triulzi DJ, Alarcon LH, Sperry JL, Murdock A, Yazer MH. Measurement of haemolysis markers following transfusion of uncrossmatched, low-titre, group O+ whole blood in civilian trauma patients: initial experience at a level 1 trauma centre. Transfus Med. 2017 Feb;27(1):30-35. doi: 10.1111/tme.12372. Epub 2016 Oct 12.

ReferenceCitation: Savage SA, Zarzaur BL, Pohlman TH, Brewer BL, Magnotti LJ, Croce MA, Lim GH, Martin AC. Clot dynamics and mortality: The MA-R ratio. J Trauma Acute Care Surg. 2017 Oct;83(4):628-634. doi: 10.1097/TA.0000000000001637.

ReferenceCitation: Einersen PM, Moore EE, Chapman MP, Moore HB, Gonzalez E, Silliman CC, Banerjee A, Sauaia A. Rapid thrombelastography thresholds for goal-directed resuscitation of patients at risk for massive transfusion. J Trauma Acute Care Surg. 2017 Jan;82(1):114-119. doi: 10.1097/TA.0000000000001270.

ReferenceCitation: Gonzalez E, Moore EE, Moore HB, Chapman MP, Chin TL, Ghasabyan A, Wohlauer MV, Barnett CC, Bensard DD, Biffl WL, Burlew CC, Johnson JL, Pieracci FM, Jurkovich GJ, Banerjee A, Silliman CC, Sauaia A. Goal-directed Hemostatic Resuscitation of Trauma-induced Coagulopathy: A Pragmatic Randomized Clinical Trial Comparing a Viscoelastic Assay to Conventional Coagulation Assays. Ann Surg. 2016 Jun;263(6):1051-9. doi: 10.1097/SLA.0000000000001608.

ReferenceCitation: Ince C, Boerma EC, Cecconi M, De Backer D, Shapiro NI, Duranteau J, Pinsky MR, Artigas A, Teboul JL, Reiss IKM, Aldecoa C, Hutchings SD, Donati A, Maggiorini M, Taccone FS, Hernandez G, Payen D, Tibboel D, Martin DS, Zarbock A, Monnet X, Dubin A, Bakker J, Vincent JL, Scheeren TWL; Cardiovascular Dynamics Section of the ESICM. Second consensus on the assessment of sublingual microcirculation in critically ill patients: results from a task force of the European Society of Intensive Care Medicine. Intensive Care Med. 2018 Mar;44(3):281-299. doi: 10.1007/s00134-018-5070-7. Epub 2018 Feb 6.

ReferenceCitation: Tachon G, Harrois A, Tanaka S, Kato H, Huet O, Pottecher J, Vicaut E, Duranteau J. Microcirculatory alterations in traumatic hemorrhagic shock. Crit Care Med. 2014 Jun;42(6):1433-41. doi: 10.1097/CCM.0000000000000223.

ReferenceCitation: Tanaka S, Escudier E, Hamada S, Harrois A, Leblanc PE, Vicaut E, Duranteau J. Effect of RBC Transfusion on Sublingual Microcirculation in Hemorrhagic Shock Patients: A Pilot Study. Crit Care Med. 2017 Feb;45(2):e154-e160. doi: 10.1097/CCM.0000000000002064.

ReferenceCitation: Tanaka S, Harrois A, Nicolaï C, Flores M, Hamada S, Vicaut E, Duranteau J. Qualitative real-time analysis by nurses of sublingual microcirculation in intensive care unit: the MICRONURSE study. Crit Care. 2015 Nov 6;19:388. doi: 10.1186/s13054-015-1106-3.

ReferenceCitation: Zatta AJ, McQuilten ZK, Mitra B, Roxby DJ, Sinha R, Whitehead S, Dunkley S, Kelleher S, Hurn C, Cameron PA, Isbister JP, Wood EM, Phillips LE; Massive Transfusion Registry Steering Committee. Elucidating the clinical characteristics of patients captured using different definitions of massive transfusion. Vox Sang. 2014 Jul;107(1):60-70. doi: 10.1111/vox.12121. Epub 2014 Apr 2.

ReferenceCitation: Godier A, Samama CM, Susen S. [Management of massive bleeding in 2013: seven questions and answers]. Transfus Clin Biol. 2013 May;20(2):55-8. doi: 10.1016/j.tracli.2013.02.015. Epub 2013 Apr 12. French.

ReferenceCitation: Hamada SR, Rosa A, Gauss T, Desclefs JP, Raux M, Harrois A, Follin A, Cook F, Boutonnet M; Traumabase® Group, Attias A, Ausset S, Boutonnet M, Dhonneur G, Duranteau J, Langeron O, Paugam-Burtz C, Pirracchio R, de St Maurice G, Vigué B, Rouquette A, Duranteau J. Development and validation of a pre-hospital "Red Flag" alert for activation of intra-hospital haemorrhage control response in blunt trauma. Crit Care. 2018 May 5;22(1):113. doi: 10.1186/s13054-018-2026-9.

ReferenceCitation: Nunez TC, Voskresensky IV, Dossett LA, Shinall R, Dutton WD, Cotton BA. Early prediction of massive transfusion in trauma: simple as ABC (assessment of blood consumption)? J Trauma. 2009 Feb;66(2):346-52. doi: 10.1097/TA.0b013e3181961c35.

ReferenceCitation: Pommerening MJ, Goodman MD, Holcomb JB, Wade CE, Fox EE, Del Junco DJ, Brasel KJ, Bulger EM, Cohen MJ, Alarcon LH, Schreiber MA, Myers JG, Phelan HA, Muskat P, Rahbar M, Cotton BA; MPH on behalf of the PROMMTT Study Group. Clinical gestalt and the prediction of massive transfusion after trauma. Injury. 2015 May;46(5):807-13. doi: 10.1016/j.injury.2014.12.026. Epub 2015 Feb 4.

ReferenceCitation: Yazer MH, Delaney M, Doughty H, Dunbar NM, Al-Riyami AZ, Triulzi DJ, Watchko JF, Wood EM, Yahalom V, Emery SP. It is time to reconsider the risks of transfusing RhD negative females of childbearing potential with RhD positive red blood cells in bleeding emergencies. Transfusion. 2019 Dec;59(12):3794-3799. doi: 10.1111/trf.15569. Epub 2019 Oct 18.

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: Raux M, Le Manach Y, Gauss T, Baumgarten R, Hamada S, Harrois A, Riou B, Duranteau J, Langeron O, Mantz J, Paugam-Burtz C, Vigue B; TRAUMABASE Group. Comparison of the Prognostic Significance of Initial Blood Lactate and Base Deficit in Trauma Patients. Anesthesiology. 2017 Mar;126(3):522-533. doi: 10.1097/ALN.0000000000001490.

ReferenceCitation: Régnier MA, Raux M, Le Manach Y, Asencio Y, Gaillard J, Devilliers C, Langeron O, Riou B. Prognostic significance of blood lactate and lactate clearance in trauma patients. Anesthesiology. 2012 Dec;117(6):1276-88. doi: 10.1097/ALN.0b013e318273349d.

ReferenceCitation: Manikis P, Jankowski S, Zhang H, Kahn RJ, Vincent JL. Correlation of serial blood lactate levels to organ failure and mortality after trauma. Am J Emerg Med. 1995 Nov;13(6):619-22.

ReferenceCitation: Abramson D, Scalea TM, Hitchcock R, Trooskin SZ, Henry SM, Greenspan J. Lactate clearance and survival following injury. J Trauma. 1993 Oct;35(4):584-8; discussion 588-9.

ReferenceCitation: Smith IM, Crombie N, Bishop JR, McLaughlin A, Naumann DN, Herbert M, Hancox JM, Slinn G, Ives N, Grant M, Perkins GD, Doughty H, Midwinter MJ; RePHILL Trial Collaborators. RePHILL: protocol for a randomised controlled trial of pre-hospital blood product resuscitation for trauma. Transfus Med. 2018 Oct;28(5):346-356. doi: 10.1111/tme.12486. Epub 2017 Nov 28.

ReferenceCitation: Boutonnet M, Abback P, Le Saché F, Harrois A, Follin A, Imbert N, Cap AP, Trichereau J, Ausset S; Traumabase Group. Tranexamic acid in severe trauma patients managed in a mature trauma care system. J Trauma Acute Care Surg. 2018 Jun;84(6S Suppl 1):S54-S62. doi: 10.1097/TA.0000000000001880.

ReferenceCitation: Riou B, Thicoïpe M, Atain-Kouadio P, Carli P. Comment evaluer la gravité? In: France S de, editor. Actualités en réanimation préhospitalière, Paris: Société française d'éditions médicales; 2002.

ReferenceCitation: Duranteau J, Asehnoune K, Pierre S, Ozier Y, Leone M, Lefrant J-Y. Recommandations sur la réanimation du choc hémorragique. Anesthésie & Réanimation 2015;1:62-74. https://doi.org/10.1016/j.anrea.2014.12.007.

ReferenceCitation: Massive transfusion in trauma guidelines. American College of Surgeons. Quality improvement project: trauma resuscitation best practice guidelines. Chicago (IL): American College of Surgeons 2013.

ReferenceCitation: Miller RD. Massive blood transfusions: the impact of Vietnam military data on modern civilian transfusion medicine. Anesthesiology. 2009 Jun;110(6):1412-6. doi: 10.1097/ALN.0b013e3181a1fd54. Review.

ReferenceCitation: Brohi K, Levy H, Boffard K, Riou B, Kiepert P, Zielske D. Normalization of lactate within 8 hours or ≥20% clearance in initial 2 hours correlates with outcomes from traumatic hemorrhagic shock. Critical Care Medicine 2011;39:177.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility:
HIA Percy
CHU du Kremlin Bicêtre
CHU de Grenoble
CHU de La Cavale Blanche - Brest
HIA Sainte Anne


title: A Phase II Prospective Immune Neoadjuvant Therapy Study od Durvalumab (MEDI4736) in Early Stage Non-small Cell Lung Cancer

acronym: IONESCO

summary:
Lung cancer is still the leading cause of cancer related-deaths worldwide, with an overall all-stage 5-year survival of approximately 17%. The primary treatment of early stage (I-IIIA) NSCLC is curative surgery. Although patients treated with curative surgery have a better prognosis, the 5-year survival for patients treated with surgery alone remains low, ranging from 67% (stage IA) to 23% (stage IIIA). Several randomized trials comparing postoperative chemotherapy versus no chemotherapy have shown a significant overall survival benefit from postoperative chemotherapy in completely resected patients with NSCLC stage II and IIIA. Likewise other randomized trials have demonstrated preoperative chemotherapy improves survival and recently the analyses also based on individual patients data of 15 randomized trials showed a significant benefit of preoperative chemotherapy on survival with the same survival improvement of 5% at 5 years. Then, neoadjuvant chemotherapy has also become accepted in many countries.

Targeting of PD-1 receptors and its ligand PD-L1, and inhibiting their engagement is an attractive therapeutic option in the early stage NSCLC, which may reactivate host immune responses and enable longterm tumor control.

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility: Institut de Cancérologie de l'Ouest - site René Gauducheau


title: Evaluation of Emergency Department (ED) Staff Stress Level During COVID-19 Pandemic

acronym: COVER-PRO

summary:
In the context of the COVID-19 pandemic, Emergency Department (ED) are in front line for the reception of patients presenting COVID-19 symptoms and have to face a new situation given the expected number of patients. Staff participate in suspect patients triage, in the diagnosis and the management of Covid-19 patients, having to follow the instructions and recommendations that evolve in real time, depending on the stage, resources and means available. This situation requires that the staff immediately adaptation within this reorganization and redeployment of the activity. Then; they are subject to many stress and anxiety factors such as:

Increased activity: massive influx of patients, overload of work, lack of material and human resources
Modification of practices: training in procedures, measures isolation and prevention of contamination of other patients, replacement by professionals reassigned from other departments
Ethical dilemma: decisions to be made in an emergency, patient prioritization
Numerous, evolving information, from various sources and sometimes contradictory (national, governance, service, media)
Individual: fear of personal contamination and of those close to you, personal organization in a situation of confinement of the population, loss of usual social support
Anxiety and stress management of patients and relatives, their entourage and colleagues In this study, it is proposed to study the psychic impact of the COVID-19 pandemic on emergency department staff.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service d'accueil des urgences, Hôpital Edouard Herriot, Hospices Civlis de Lyon

location_facility: Service d'accueil des urgences, Hôpital Lyon Sud, Hospices Civils de Lyon

location_facility: Service d'accueil des urgences, Hôpital de la Croix-Rousse, Hospices Civils de Lyon


title: Assessing Long-term Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions-LEA

acronym: LEA

summary: The primary objective of this study is to evaluate long-term effectiveness of adalimumab in pediatric participants starting a treatment for Crohn's disease in real life conditions, namely to describe the time to loss of clinical benefit in a time to event approach. Main secondary objectives are to describe growth and pubertal development and to describe long-term safety. The participants will be followed-up up to 10 years.

lead_sponsor: AbbVie

location_facility: CHU Bordeaux-Hopital Pellegrin /ID# 154620

location_facility: Charles Nicolle Hosp chu rouen /ID# 158688

location_facility: Charles Nicolle Hosp chu rouen /ID# 152670

location_facility: Centre Hospitalier Universitai /ID# 155465

location_facility: CHU de Besancon - Jean Minjoz /ID# 154197

location_facility: CHU de Rennes - Hospital Sud /ID# 152730


title: Assessment of the Presence of the SARS-COV-2 Virus in the Peritoneum During an Emergency Laparoscopy Conducted on Confirmed or Suspected COVID-19 Patients

acronym: LAPTRANSCOV

summary: The purpose of this study is to determine whether the virus SARS-CoV-2, responsible for the disease COVID-19, is present in the abdominal cavity during emergency laparoscopic exploration in confirmed or suspected COVID-19 patients.

lead_sponsor: Centre Hospitalier René Dubos

location_facility: Department of Gynecology-Obstetrics, Hospital René Dubos

location_facility: Department of General and Digestive Surgery, Hospital René Dubos


title: Efficacy of Sarilumab + Azithromycin + Hydroxychloroquine, and Sarilumab Alone, for Adult Patients Hospitalized With Moderate to Severe COVID-19: a Multicenter Open-label 1:1 Randomized Controlled Trial

acronym: CORIMUNO-VIRO

summary: The overall objective of the study is to determine the therapeutic effect and tolerance of Sarilumab in combination with Azithromycin and Hydroxychloroquine, compared to Sarilumab only, patients with moderate, severe pneumonia associated with Coronavirus disease 2019 (COVID-19). Sarilumab is a human IgG1 monoclonal antibody that binds specifically to both soluble and membrane-bound IL-6Rs (sIL-6Rα and mIL-6Rα) and has been shown to inhibit IL-6-mediated signaling through these receptors. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering investigational treatments administration to patients enrolled in the CORIMUNO-19 cohort (NCT04324047). Sarilumab+Azithromycin+Hydroxychloroquine, or Sarilumab only will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation. All patients will receive standard of care along with randomized investigational treatments. Outcomes of included patients will be compared between groups as well as with outcomes of patients in the CORIMUNO-19 cohort treated with other immune modulators or standard of care.

status: Suspended

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
AP-HP Hôpital Ambroise Paré
AP-HP Hôpital Saint Antoine
AP-HP Hôpital Pitié Salpétrière
AP-HP Hôpital Avicenne
AP-HP Hôpital Beaujon