title: Phase II Study, Multicenter, Randomized, Stratified, Evaluating the Efficacity of Weekly Paclitaxel, With or Without Bevacizumab in the Treatment of Metastatic or Locally Advanced Angiosarcomas Not Accessible to Surgery Treatment.

acronym: ANGIO-TAX+

summary: Efficacity of Paclitaxel in association or not with Bevacizumab in treatment of angiosarcoma

ReferenceCitation: Lebellec L, Bertucci F, Tresch-Bruneel E, Ray-Coquard I, Le Cesne A, Bompas E, Blay JY, Italiano A, Mir O, Ryckewaert T, Toiron Y, Camoin L, Goncalves A, Penel N, Le Deley MC. Prognostic and predictive factors for angiosarcoma patients receiving paclitaxel once weekly plus or minus bevacizumab: an ancillary study derived from a randomized clinical trial. BMC Cancer. 2018 Oct 11;18(1):963. doi: 10.1186/s12885-018-4828-1.

family: Lebellec

full_name: Loïc Lebellec

given: Loïc

family: Bertucci

full_name: François Bertucci

given: François

family: Tresch-Bruneel

full_name: Emmanuelle Tresch-Bruneel

given: Emmanuelle

family: Ray-Coquard

full_name: Isabelle Ray-Coquard

given: Isabelle

family: Le Cesne

full_name: Axel Le Cesne

given: Axel

family: Bompas

full_name: Emmanuelle Bompas

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

family: Italiano

full_name: Antoine Italiano

given: Antoine

family: Mir

full_name: Olivier Mir

given: Olivier

family: Ryckewaert

full_name: Thomas Ryckewaert

given: Thomas

family: Toiron

full_name: Yves Toiron

given: Yves

family: Camoin

full_name: Luc Camoin

given: Luc

family: Goncalves

full_name: Anthony Goncalves

given: Anthony

family: Penel

full_name: Nicolas Penel

given: Nicolas

family: Le Deley

full_name: Marie-Cécile Le Deley

given: Marie-Cécile

journal_name: BMC Cancer

repository_normalized: LillOA (Lille Open Archive)

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

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central

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

location_facility:
Centre Antoine Lacassagne
Centre Léon Bérard
Centre François Baclesse
Institut Gustave Roussy
Centre Val d'Aurelle
Centre Oscar Lambret
Centre Georges François Leclerc
Centre Jean Perrin
Institut Claudius Regaud
Institut Curie
Centre René Gauducheau
Institut Bergonié
Institut de Cancérologie de la Loire


type: Registry Identifier

title: Exogenous Surfactant in Very Preterm Neonates Presenting With Severe Respiratory Distress in Prevention of Bronchopulmonary Dysplasia

acronym: CURDYS

summary: Advances in perinatal care have made it possible to improve the survival of the most immature neonates, but at the cost of an increase in the population at risk of developing bronchopulmonary dysplasia (BPD). Measures that have attempted to limit the development of BPD are not always effective, or related to major side effects. The physiopathological factors that are identified in BPD should, in theory, respond to surfactant. Therefore, the use of an exogenous surfactant in neonates presenting with pulmonary disease requiring mechanical ventilation, leading to a significant risk of BPD, should allow earlier extubation and thus promote pulmonary healing and growth.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: result

ReferenceCitation: Hascoët JM, Picaud JC, Ligi I, Blanc T, Moreau F, Pinturier MF, Zupan V, Guilhoto I, Hamon IR, Alexandre C, Bouissou A, Storme L, Patkai J, Pomedio M, Rouabah M, Coletto L, Vieux R. Late Surfactant Administration in Very Preterm Neonates With Prolonged Respiratory Distress and Pulmonary Outcome at 1 Year of Age: A Randomized Clinical Trial. JAMA Pediatr. 2016 Apr;170(4):365-72. doi: 10.1001/jamapediatrics.2015.4617.

name: Maternite Regionale Universitaire, EA 3450 Devah, Université de Lorraine, Nancy, France

family: Hascoët

full_name: Jean-Michel Hascoët

given: Jean-Michel

sequence: first

name: Hôpital de la Croix-Rousse, Hospices Civils de Lyon, Lyon, France

family: Picaud

full_name: Jean-Charles Picaud

given: Jean-Charles

sequence: additional

name: Assistance Publique-Hopitaux Marseille, Marseille, France

family: Ligi

full_name: Isabelle Ligi

name: Centre Hospitalier Universitaire Rouen, Rouen, France

family: Blanc

full_name: Thierry Blanc

given: Thierry

name: Centre Hospitalier Universitaire Amiens, Amiens, France

family: Moreau

full_name: Francois Moreau

given: Francois

name: Centre Hospitalier Montreuil, Montreuil, France

family: Pinturier

full_name: Marie-Frederique Pinturier

given: Marie-Frederique

name: Assistance Publique-Hopitaux Clamart, Clamart, France

family: Zupan

full_name: Véronique Zupan

given: Véronique

family: Guilhoto

full_name: Isaura Guilhoto

given: Isaura

family: Hamon

full_name: Isabelle R. M. Hamon

given: Isabelle R. M.

name: Centre Hospitalier Universitaire Caen, Caen, France

family: Alexandre

full_name: Ceneric Alexandre

given: Ceneric

name: Centre Hospitalier Universitaire Tours, Tours, France

family: Bouissou

full_name: Antoine Bouissou

name: Centre Hospitalier Universitaire Lille, Lille, France

family: Storme

full_name: Laurent Storme

given: Laurent

name: Assistance Publique-Hopitaux Paris Port Royal, Paris, France

family: Patkai

full_name: Juliana Patkai

given: Juliana

name: Centre Hospitalier Universitaire Reims, Reims, France

family: Pomedio

full_name: Mickael Pomedio

given: Mickael

family: Rouabah

full_name: Mahmoud Rouabah

given: Mahmoud

family: Coletto

full_name: Ludivine Coletto

given: Ludivine

name: Maternite Regionale Universitaire, EA 4360 APEMAC, Université de Lorraine, Nancy, France

family: Vieux

full_name: Rachel Vieux

given: Rachel

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: JAMA Pediatrics

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

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

repository_normalized: HAL

publisher: American Medical Association (AMA)

ReferenceCitation: Hascoët JM, Picaud JC, Ligi I, Blanc T, Daoud P, Zupan V, Moreau F, Guilhoto I, Rouabah M, Alexandre C, Saliba E, Storme L, Patkai J, Pomedio M, Hamon I. Review shows that using surfactant a number of times or as a vehicle for budesonide may reduce the risk of bronchopulmonary dysplasia. Acta Paediatr. 2018 Jul;107(7):1140-1144. doi: 10.1111/apa.14171. Epub 2017 Dec 22. Review.

name: DevAH; University of Lorraine; Maternité Régionale; CHRU; Nancy France

name: Neonatal Unit; Hôpital de la croix rousse; Hospices Civils; Lyon France

location_facility:
CHU Hopital Clemenceau
CHU Hopital Jeanne de Flandre
CHI Andre Gregoire
AP-HP Hopital Port Royal
Centre Hospitalier
CHU Hopital de la Croix Rousse
CHU hopital d'enfants
CHU Hopital Gatien de Clocheville
CHU Hopital Nord
Maternite Regionale Universitaire
CHU
APHM hopital de la conception


title: Multicenter, Randomised Open Trial Comparing the Efficacy of a Medical Treatment With Sandostatin LP 30 mg Performed Before Surgery to a Prime Line transsphenoïdal Surgery in Previously Untreated Acromegalic Patients With Either a Micro or a Macro Pituitary Adenoma

acronym: SAPORO

summary: The aim of the study is to evaluate the interest of a six month pre-operative treatment with a long-acting somatostatin analog (Sandostatin LP) versus surgery alone in patients with a pituitary adenoma responsible for acromegaly.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: University Hospital, Rouen

location_facility:
Paris XI University Hospital
Strasbourg University Hospital
Lyon University Hospital
Besançon University Hospital
Lille University Hospital
Grenoble University Hospital
Rouen University Hospital
Marseille University Hospital
Toulouse Universtiy Hospital
Caen University Hospital
Angers University Hospital
Bordeaux University Hospital
University Hospital of Limoges

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Completed


title: Open Comparative Study With a Cross-over According to Patients'Preference Receiving Xeloda or UFT With Folinic Acid in Advanced or Metastatic Colo-rectal Cancer

acronym: COLOCROSS

summary:
The scope of the trial is to determine the preference of patients, after randomization and cross-over, for one of the two treatments.

Another objective of the trial is to assess and compare the safety of each treatment.

lead_sponsor: Centre Oscar Lambret

location_facility:
Centre Joliot-Curie
Centre Hospitalier de CHOLET
Centre Leonard de Vinci
Centre Paul Papin
Centre Oscar Lambret
Centre Hospitalier
Centre Hospitalier Regional
Centre Hospitalier de Béthune
Hopital Saint Vincent de Paul
Clinique des Dentellieres
Polyclinique du Bois

lead_sponsor_type: industriel


title: Treatment of Acute Severe Alcoholic Hepatitis With Corticoids Plus N Acetyl Cysteine Versus Corticoids Alone: a French Multicentre Randomized Controlled Study.

acronym: HAA-NAC

summary: 35% of Acute Alcoholic Hepatitis patients (AAH) do not respond to corticoids and died after 6 months. Chronic alcohol abuse depletes glutathione in the hepatocytes and makes the latter more sensitive to excessive TNFα levels. Re-establishment of a stock of antioxidants by administration of a precursor (N-acetyl cysteine, NAC) in combination with corticoids (C) could make the hepatocytes more resistant and improve survival. The investigators' study's primary endpoint was improvement of survival at 6 months. The secondary endpoints were survival at 1 and 3 months, tolerance of NAC and a drop in blood bilirubin levels at D7

ReferenceType: derived

ReferenceCitation: Nguyen-Khac E, Thevenot T, Piquet MA, Benferhat S, Goria O, Chatelain D, Tramier B, Dewaele F, Ghrib S, Rudler M, Carbonell N, Tossou H, Bental A, Bernard-Chabert B, Dupas JL; AAH-NAC Study Group. Glucocorticoids plus N-acetylcysteine in severe alcoholic hepatitis. N Engl J Med. 2011 Nov 10;365(19):1781-9. doi: 10.1056/NEJMoa1101214.

family: Nguyen-Khac

full_name: Eric Nguyen-Khac

given: Eric

family: Thevenot

full_name: Thierry Thevenot

family: Piquet

full_name: Marie-Astrid Piquet

given: Marie-Astrid

family: Benferhat

full_name: Saïd Benferhat

given: Saïd

family: Goria

full_name: Odile Goria

given: Odile

family: Chatelain

full_name: Denis Chatelain

given: Denis

family: Tramier

full_name: Blaise Tramier

given: Blaise

family: Dewaele

full_name: François Dewaele

given: François

family: Ghrib

full_name: Salah Ghrib

given: Salah

family: Rudler

full_name: Marika Rudler

given: Marika

family: Carbonell

full_name: Nicolas Carbonell

given: Nicolas

family: Tossou

full_name: Hervé Tossou

given: Hervé

family: Bental

full_name: Abdeslam Bental

given: Abdeslam

family: Bernard-Chabert

full_name: Brigitte Bernard-Chabert

given: Brigitte

family: Dupas

full_name: Jean-Louis Dupas

given: Jean-Louis

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Glucocorticoids plusN-Acetylcysteine in Severe Alcoholic Hepatitis

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: Centre Hospitalier Universitaire de Reims

location_facility: Centre Hospitalier Universitaire de Besançon

location_facility: Centre Hospitalier Universitaire Pitié-Salpétrière

location_facility: Centre Hospitalier Universitaire de Rouen


title: Randomized Trial Comparing Liver Transplantation to Alternative Therapies for Patients With Pugh B Alcoholic Cirrhosis

acronym: TRANSCIAL

summary: Liver transplantation has been universally recognized to improve survival of patients suffering from end-stage (Pugh C) alcoholic cirrhosis. However, for Pugh B patients, the benefit of liver transplantation remains to be demonstrated. The aim of the present study was to compare the outcome of Pugh B patients with alcoholic cirrhosis randomly assigned for immediate liver transplantation (group 1) or standard treatments (group 2).

ReferenceCitation: Vanlemmens C, Di Martino V, Milan C, Messner M, Minello A, Duvoux C, Poynard T, Perarnau JM, Piquet MA, Pageaux GP, Dharancy S, Silvain C, Hillaire S, Thiefin G, Vinel JP, Hillon P, Collin E, Mantion G, Miguet JP; TRANSCIAL Study Group. Immediate listing for liver transplantation versus standard care for Child-Pugh stage B alcoholic cirrhosis: a randomized trial. Ann Intern Med. 2009 Feb 3;150(3):153-61.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre d'épidémiologie de population EPI 106

location_facility: CHRU CAEN - Service d'hépato-gastroentérologie

location_facility: Hôpital Pitié-Salpétrière - Hépato-gastroentérologie

location_facility: Clinique des maladies du foie Hôpital Pontchailloux

location_facility: Hôpital Beaujon - Hépato-gastroentérologie

location_facility: Hôpital Purpan - Hépato-gastroentérologie

location_facility: Hôpital Bon secours - Hépato-gastroentérologie

location_facility: CHU Henri Mondor - Hépato-gastroentérologie

location_facility: Hôpital Saint-Eloi - Hépato-gastroentérologie

intervention_type: Other


title: Neoadjuvant Treatment for Operable Esophageal Cancer With 5-fluorouracil, Cisplatin, and Cetuximab and Concurrent Radiotherapy: Phase I/II Study

summary:
RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving fluorouracil and cisplatin together with cetuximab and radiation therapy may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of fluorouracil and cisplatin when given together with cetuximab and radiation therapy in treating patients with esophageal cancer that can be removed by surgery.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: Centre Hospital Universitaire Hop Huriez

intervention_type: Procedure


title: A Randomized Multicenter Study of More Intensive Versus Less Intensive Post-Remission Therapy in Elderly Patients With Acute Myelogenous Leukemia (AML) or Transformed Refractory Anemia With Excess Blasts (RAEB-t).

summary: In this ALFA-9803 trial in AML patients aged 65 years or more, we randomly compared idarubicin or daunorubicin throughout the study (first randomization) and two different post-remission strategies (second randomization): one single intensive consolidation course similar to induction versus six ambulatory cycles with one dose of idarubicin/daunorubicin (day 1) and 2x60 mg/m2/d cytarabine SC (day 1 to 5) delivered in out-patients on a monthly basis. Primary endpoint was 2-year overall survival (OS). Study hypotheses were equivalence for the idarubicin/daunorubicin comparison and a 15% difference in 2-year OS for the post-remission therapy comparison.

status: Terminated

ReferenceCitation: Sarkozy C, Gardin C, Gachard N, Merabet F, Turlure P, Malfuson JV, Pautas C, Micol JB, Thomas X, Quesnel B, Celli-Lebras K, Preudhomme C, Terré C, Fenaux P, Chevret S, Castaigne S, Dombret H. Outcome of older patients with acute myeloid leukemia in first relapse. Am J Hematol. 2013 Sep;88(9):758-64. doi: 10.1002/ajh.23498. Epub 2013 Aug 7.

family: Sarkozy

full_name: Clémentine Sarkozy

given: Clémentine

name: Hematology Department, Hôpital Avicenne, AP-HP; University Paris 13; Bobigny; France

family: Gardin

full_name: Claude Gardin

given: Claude

name: Hematology Department, Hôpital Dupuytren; University Limoges; Limoges; France

family: Gachard

full_name: Nathalie Gachard

given: Nathalie

name: Hematology Department, Hôpital Mignot; University Versailles - Saint Quentin; Le Chesnay; France

family: Merabet

full_name: Fathia Merabet

given: Fathia

family: Turlure

full_name: Pascal Turlure

given: Pascal

name: Hematology Department; Hôpital d'Instruction des Armées; Clamart; France

family: Malfuson

full_name: Jean-Valère Malfuson

given: Jean-Valère

name: Hematology Department, Hôpital Henri Mondor, AP-HP; University Paris 12; Créteil; France

family: Pautas

full_name: Cécile Pautas

given: Cécile

name: Hematology Department, Hôpital Saint-Louis, Assistance Publique - Hôpitaux de Paris (AP-HP); University Paris 7; EA 3518; Paris; France

family: Micol

full_name: Jean-Baptiste Micol

given: Jean-Baptiste

name: Hematology Department; Hôpital Lyon Sud; Pierre-Bénite; France

family: Thomas

full_name: Xavier Thomas

given: Xavier

name: Hematology Department, Hôpital Claude Huriez; University Lille; Lille; France

family: Quesnel

full_name: Bruno Quesnel

given: Bruno

family: Celli-Lebras

full_name: Karine Celli-Lebras

given: Karine

family: Preudhomme

full_name: Claude Preudhomme

family: Terré

full_name: Christine Terré

given: Christine

family: Fenaux

full_name: Pierre Fenaux

given: Pierre

name: Department of Biostatistics, Hôpital Saint-Louis, AP-HP; University Paris 7; Paris; France

family: Chevret

full_name: Sylvie Chevret

given: Sylvie

family: Castaigne

full_name: Sylvie Castaigne

family: Dombret

full_name: Hervé Dombret

journal_name: American Journal of Hematology

oa_host_type: publisher

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Gardin C, Chevret S, Pautas C, Turlure P, Raffoux E, Thomas X, Quesnel B, de Revel T, de Botton S, Gachard N, Renneville A, Boissel N, Preudhomme C, Terré C, Fenaux P, Bordessoule D, Celli-Lebras K, Castaigne S, Dombret H. Superior long-term outcome with idarubicin compared with high-dose daunorubicin in patients with acute myeloid leukemia age 50 years and older. J Clin Oncol. 2013 Jan 20;31(3):321-7. doi: 10.1200/JCO.2011.40.3642. Epub 2012 Dec 17.

name: Claude Gardin and Pierre Fenaux, Hôpital Avicenne, Assistance Publique–Hôpitaux de Paris (AP-HP), Université Paris 13, Bobigny; Sylvie Chevret, Emmanuel Raffoux, Nicolas Boissel, Karine Celli-Lebras, and Hervé Dombret, Hôpital Saint-Louis, AP-HP, Université Paris 7, Paris; Cécile Pautas, Hôpital Henri Mondor, AP-HP, Université Paris 12, Créteil; Pascal Turlure, Nathalie Gachard, and Dominique Bordessoule, Hôpital Dupuytren, Université de Limoges, Limoges; Xavier Thomas, Hôpital Edouard Herriot,...

publisher: American Society of Clinical Oncology (ASCO)

title: Superior Long-Term Outcome With Idarubicin Compared With High-Dose Daunorubicin in Patients With Acute Myeloid Leukemia Age 50 Years and Older

ReferenceCitation: Itzykson R, Gardin C, Pautas C, Thomas X, Turlure P, Raffoux E, Terré C, Fenaux P, Castaigne S, Dombret H, Boissel N; Acute Leukemia French Association (ALFA). Impact of post-remission therapy in patients aged 65-70 years with de novo acute myeloid leukemia: a comparison of two concomitant randomized ALFA trials with overlapping age inclusion criteria. Haematologica. 2011 Jun;96(6):837-44. doi: 10.3324/haematol.2010.036921. Epub 2011 Apr 1.

name: for the Acute Leukemia French Association (ALFA)

publisher: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Malfuson JV, Etienne A, Turlure P, de Revel T, Thomas X, Contentin N, Terré C, Rigaudeau S, Bordessoule D, Vey N, Gardin C, Dombret H; Acute Leukemia French Association (ALFA). Risk factors and decision criteria for intensive chemotherapy in older patients with acute myeloid leukemia. Haematologica. 2008 Dec;93(12):1806-13. doi: 10.3324/haematol.13309. Epub 2008 Oct 6.

location_facility:
Hopital Avicenne
CH
Hopital Henri Mondor
Hopital Pitie-Salpetriere
Hopital Edouard Herriot
CNLCC
Hopital Saint-Louis
CHU
Hopital Percy
IGR


title: National Multicenter Randomized Trial, Comparing Two Treatments of Myocardial Infarction Complicated With Cardiogenic Shock: Standard Treatment vs Standard Treatment Plus ECLS (Extracorporeal Life Support)

summary:
Cardiogenic shock is currently the main cause of death after myocardial infarction and 50% of deaths occur within the first 48 hours. To limit the extent of the myocardial necrosis is the primary objective of the treatment in this context. The symptomatic treatment of the ventricular failure alone does not allow a reduction of mortality. The immediate prognosis is not significantly improved by the current standard of care, including early revascularisation and intra-aortic balloon counterpulsation.

In order to improve the immediate prognosis, it seems necessary to limit the irreversible myocardial lesions and the systemic inflammatory response induced by an extended myocardial infarction (complement activation, cytokines production, iNOS expression, etc.). These objectives may be reached by a more extended utilization and availability of circulatory assistance methods.

The investigators propose to compare, in a randomised multicenter study, two treatments of the myocardial infarction with cardiogenic shock among 44 patients:

Standard Treatment versus ECLS-Impella +/- standard treatment.

In June 2007, an amendment replaced the device ECMO by the use of Impella intra-thoracic pump.

This amendment has been approved by the Ethic Committee on July 7, 2007. In March 2009, a new amendment has been approved by the EC. This amendment allowed to revise the number of patients to enroll (reduced to 44) and this lead us to modify also the primary endpoint : variation of BNP levels between H0 and H24 (H0 defined as the nearest value of BNP level obtained before the randomization).Showing a more important BNP levels decrease in the experimental group compared to standard treatment group, the investigators obtain an indirect argument to show a superior efficacy of the tested strategy.

lead_sponsor: University Hospital, Caen

location_facility:
Mulhouse Hospital
Clermont-Ferrand University Hospital
Brest University Hospital
Paris Sud Cardiovascular Institute
Hôpital de la Timone
Hôpital Charles Nicolle
Cochin Hospital
Hôpital Haut-Lévèque
Caen University Hospital
Pitié-Salpétrière Hospital
Hôpital de la Croix Rousse
Toulouse University Hospital
Centre Cardiologique du Nord

intervention_type: Device

status_simplified: Unknown


type: Other Identifier

title: Pharmaco-epidemiological Study of COVID 19 Vaccines in Patients Undergoing Immunotherapy for Cancer. A Retrospective Open Cohort Study.

acronym: IVACOV

summary: The investigators wish to set up a pharmaco-epidemiological cohort within the Hospital Territorial Groups of the Cévennes-Gard Camargue, East-Hérault and Haute-Garonne and West Tarn on a specific population, patients undergoing immunotherapy for cancer, as currently there is no data available under "real life" conditions following anti-COVID vaccination19. The hypothesis is that patients undergoing immunotherapy will not develop more vaccine-related adverse events than those observed in the efficacy and safety validation studies of the BNT162b2 mRNA Covid-19, mRNA-1273 SARS CoV-2, Oxford/AstraZeneca and Ad26COV2.S, JMJ Vaccine or J & J COVID-19 Vaccine.

status: Recruiting

study_type: Observational

time_perspective: Retrospective

ReferenceType: background

ReferenceCitation: Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, Diemert D, Spector SA, Rouphael N, Creech CB, McGettigan J, Khetan S, Segall N, Solis J, Brosz A, Fierro C, Schwartz H, Neuzil K, Corey L, Gilbert P, Janes H, Follmann D, Marovich M, Mascola J, Polakowski L, Ledgerwood J, Graham BS, Bennett H, Pajon R, Knightly C, Leav B, Deng W, Zhou H, Han S, Ivarsson M, Miller J, Zaks T; COVE Study Group. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2021 Feb 4;384(5):403-416. doi: 10.1056/NEJMoa2035389. Epub 2020 Dec 30.

ReferenceCitation: Knoll MD, Wonodi C. Oxford-AstraZeneca COVID-19 vaccine efficacy. Lancet. 2021 Jan 9;397(10269):72-74. doi: 10.1016/S0140-6736(20)32623-4. Epub 2020 Dec 8.

ReferenceCitation: Voysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK, Angus B, Baillie VL, Barnabas SL, Bhorat QE, Bibi S, Briner C, Cicconi P, Collins AM, Colin-Jones R, Cutland CL, Darton TC, Dheda K, Duncan CJA, Emary KRW, Ewer KJ, Fairlie L, Faust SN, Feng S, Ferreira DM, Finn A, Goodman AL, Green CM, Green CA, Heath PT, Hill C, Hill H, Hirsch I, Hodgson SHC, Izu A, Jackson S, Jenkin D, Joe CCD, Kerridge S, Koen A, Kwatra G, Lazarus R, Lawrie AM, Lelliott A, Libri V, Lillie PJ, Mallory R, Mendes AVA, Milan EP, Minassian AM, McGregor A, Morrison H, Mujadidi YF, Nana A, O'Reilly PJ, Padayachee SD, Pittella A, Plested E, Pollock KM, Ramasamy MN, Rhead S, Schwarzbold AV, Singh N, Smith A, Song R, Snape MD, Sprinz E, Sutherland RK, Tarrant R, Thomson EC, Török ME, Toshner M, Turner DPJ, Vekemans J, Villafana TL, Watson MEE, Williams CJ, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021 Jan 9;397(10269):99-111. doi: 10.1016/S0140-6736(20)32661-1. Epub 2020 Dec 8. Erratum in: Lancet. 2021 Jan 9;397(10269):98.

ReferenceCitation: Sadoff J, Gray G, Vandebosch A, Cárdenas V, Shukarev G, Grinsztejn B, Goepfert PA, Truyers C, Fennema H, Spiessens B, Offergeld K, Scheper G, Taylor KL, Robb ML, Treanor J, Barouch DH, Stoddard J, Ryser MF, Marovich MA, Neuzil KM, Corey L, Cauwenberghs N, Tanner T, Hardt K, Ruiz-Guiñazú J, Le Gars M, Schuitemaker H, Van Hoof J, Struyf F, Douoguih M; ENSEMBLE Study Group. Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19. N Engl J Med. 2021 Jun 10;384(23):2187-2201. doi: 10.1056/NEJMoa2101544. Epub 2021 Apr 21.

ReferenceCitation: Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Pérez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Türeci Ö, Nell H, Schaefer A, Ünal S, Tresnan DB, Mather S, Dormitzer PR, Şahin U, Jansen KU, Gruber WC; C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 31;383(27):2603-2615. doi: 10.1056/NEJMoa2034577. Epub 2020 Dec 10.

ReferenceCitation: Anderson EJ, Rouphael NG, Widge AT, Jackson LA, Roberts PC, Makhene M, Chappell JD, Denison MR, Stevens LJ, Pruijssers AJ, McDermott AB, Flach B, Lin BC, Doria-Rose NA, O'Dell S, Schmidt SD, Corbett KS, Swanson PA 2nd, Padilla M, Neuzil KM, Bennett H, Leav B, Makowski M, Albert J, Cross K, Edara VV, Floyd K, Suthar MS, Martinez DR, Baric R, Buchanan W, Luke CJ, Phadke VK, Rostad CA, Ledgerwood JE, Graham BS, Beigel JH; mRNA-1273 Study Group. Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults. N Engl J Med. 2020 Dec 17;383(25):2427-2438. doi: 10.1056/NEJMoa2028436. Epub 2020 Sep 29.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
Centre Hospitalier de Toulouse
Clinique Claude Bernard
CH d'Auch
CH de Bagnols sur Cèze
CH de Cahors
Clinique des Cèdres - Capio
Institut de Cancer de Montpellier
Centre Hospitalier d'Albi
Centre Hospitalier d'Alès
Centre Hospitalier du bassin de Thau
CH de Bigorre
Clinique La Croix du Sud

status_simplified: Ongoing


title: Randomized, Multicentre, Phase II Study Evaluating the Interest of Imatinib Treatment Maintenance or Interruption After at Least 10 Years of Treatment in Patients With Locally Advanced/Metastatic Gastrointestinal Stromal Tumors (GISTs)

summary:
This is a 2 arms study concerning patients under imatinib treatment for at least 10 years of treatment with locally advanced/metastatic GIST.

In the first arm, patients will discontinue Imatinib treatment. This arm will allow to determine if the re-introduction of Imatinib at relapse is still an efficient treatment for the control of disease.

In the second arm, patients will continue Imatinib treatment, allowing to determine if the continuation of this treatment is efficient for disease control, by the rate of non-progression disease.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Centre Leon Berard

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

location_facility: Institut de Cancérologie Lucien NEUWIRTH


title: Endodontic Post-operative Pain Evaluation of Patients After Using Endomethasone N or Endomethasone SP Root Canal Sealer: a Prospective, Comparative Randomized Clinical Trial

acronym: EndoPOP

summary:
The study is a post-marketing performance and safety study, designed as a comparative, prospective, multicenter, simple-blind, randomized clinical trial. 300 subjects requiring a primary or a secondary root canal treatment will be enrolled in 2 groups (150 in each group). The aim of the study is to demonstrate the superiority of the hydrocortisone-containing root canal sealer Endomethasone N RCS, compared to the hydrocortisone-free root canal sealer Endomethasone SP RCS, with regard to reduction of the maximum post-operative spontaneous pain during the 7 days following the root canal treatment.

Root canal treatment procedures will be in accordance with the allocation by randomisation of Endomethasone N RCS or Endomethasone SP RCS. The spontaneous and the Masticatory pain will be record at predefined times, a phone call will be done at 48h and a visit will be realized at day 7 (max Day 14).

ipd_sharing: No

lead_sponsor: Septodont

location_facility:
Cabinet Dentaire
Cabinet dentaire
Centre de santé dentaire Chevaleret
Centre dentaire Flandre


title: A Controlled, Randomised Multicenter Study Comparing the Effectiveness of EndoRotor (New Treatment Technique) Versus Radiofrequency (Reference Technique) in Treating Barrett's Esophagus Complicated by Dysplasia

acronym: ENDOBARRETT

summary:
Barrett Esophagus is a common pathology, with an estimated prevalence of 1.6% at risk of progression to precancerous mucosa (low to high grade dysplasia). The incidence of adenocarcinoma on BE is 0.5% per year. In the event of dysplasia or cancer in situ, it is currently recommended at international and particularly European level to eradicate BE. The treatment techniques used to date carry out thermal destruction of the BE, in particular by radiofrequency. Eradication of dysplasia is achieved in 81% to 100% and disappearance of BE in 73% to 87% of cases. It requires an average of 3 destruction sessions. RF does not allow histological analysis after destruction of BE, but the risk of progression to neoplasia is estimated at 7.8/1000 persons per year. This risk could be due to the presence of glands buried in the esophageal mucosa. Indeed, these glands are not destroyed by thermal ablation methods, and remain invisible during endoscopic controls.

A new treatment technique using the Endorotor® system allows mechanical resection of the entire mucosa in one session of treatment. In addition, the cost of these thermal destruction techniques currently limits their wider diffusion. It is therefore legitimate to propose a less expensive and probably more effective alternative technique.

ipd_sharing: Undecided

lead_sponsor: University Hospital, Angers

location_facility:
University Hospital of Bordeaux
University Hospital of Brest
University Hospital of Lille
University Hospital of Rennes
Edouard Herriot Hospital
Georges Pompidou European Hospital
Cochin Hospital
University Hospital of Nice
University Hospital of Poitiers
University Hospital of Tours
University Hospital of Nantes
University Hospital of Limoges


title: Impact of Primary Care COPD Screening Strategies on the Smoking Cessation Process at 2 Years Follow-up of the Randomized, Multicenter, Clustered Controlled Trial DISCO

acronym: DISCO-SET

summary:
The general practitioner is confronted with unselected smokers whose attempts to quit smoking are often repeated over time before leading to a definitive cessation.

Each year, 3-5% of smokers succeed in quitting in the general population. The corollary is that the majority of smokers are in a situation of failure in their attempt to quit: 33% declared during the 2019 French Health Barometer to have made an attempt of at least 7 days in the past year. Thus, this status of "smoker" can cover a wide variety of situations: no attempt to stop smoking, attempt(s) of more or less clinical significance, previous support or not by a health professional, etc. Currently, the HAS recommendations do not determine a specific course of action for these smokers, whose experiences may be very different. It could therefore be interesting to objectivize the smoking cessation process of these patients who have or have not succeeded in quitting, in order to deduce profiles of smokers according to their previous smoking cessation experiences. Furthermore, the choice and relevance of the cessation criteria used are debated.

Following the randomized controlled trial DISCO on COPD screening interventions in primary care (3 intervention arms, 1 control arm), the investigators will carry out a pilot cross-sectional survey on the cessation process of smokers during the 2 years following their participation, evaluating the incidence and modalities of cessation attempts of smokers belonging to an age group at risk of COPD (40-80 years) and who initially consulted their general practitioner for any reason 2 years ago at the time of their inclusion.

The impact on future management could be the personalization of cessation advice given to smokers according to quantitative and qualitative indicators specific to their experience, their previous history of smoking cessation, their health situation and socio-demographic characteristics. Eventually, a gradation of the levels of support offered to patients in general practice on the basis of predictive factors of smoking cessation could be studied.

The investigators hypothesize that participation in COPD screening with the GP may be associated with patient progress in quitting smoking. This pilot study will be conducted on a random sample of 120 participants from the subgroup of 544 patients who were smokers at inclusion in DISCO.

time_perspective: Cross-Sectional

lead_sponsor: Rennes University Hospital

location_facility:
Marie BROSSET
Marieke SALACROUP
Laurent LENOBLE
Jean-Philippe DUGUEY
Hoël CHARBONNEL
Romain NIFENECKER
Anna JARNO-JOSSE
Lucie MURGALE
Emmanuelle FOURE-AMELOT
Antoine MOUTEL
Lucie DELATTE
Béatrice NEGARET


ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

lead_sponsor: Novartis Pharmaceuticals

location_country: Germany France Spain

acronym: STHENOS

ipd_sharing: Yes

type: EudraCT Number

source: euctr

title: Open-Label Rater-Blind Randomized Multi-Center Parallel-Arm Active- Comparator Study to Assess the Efficacy and Tolerability of Ofatumumab 20mg SC Monthly vs. First Line DMT - Physician's Choice in the Treatment of Newly Diagnosed RMS

summary: This study will compare ofatumumab vs. European approved platform first line self-administered disease modifying therapy (DMT) in newly diagnosed MS patients


title: Ezabenlimab (BI 754091) and mDCF (Docetaxel, Cisplatin and 5-fluorouracil) Followed by Chemoradiotherapy in Patients With Stage III Squamous Cell Anal Carcinoma. A Phase II Study

acronym: INTERACT-ION

summary:
Squamous cell carcinoma of the anus (SCCA) is a rare cancer, however its incidence is increasing worldwide. SCCA is mostly induced by human papillomavirus (HPV) infections (high-risk types such as HPV-16 and -18) and HPV-related oncoproteins (E6 and E7) are expressed in more than 90% of cases. T stage and N stage are recognized prognostic factors for local and/or distant recurrence in SCCA patients treated by CRT. In fact, ≥T3 or ≥N1 anal cancers are associated with as high as 50% disease recurrence rate at 2 years.

Since 1996 when concomitant radiotherapy and MMC (mytomicin C) and 5-FU-based chemotherapy demonstrated superiority to radiotherapy alone, no significant progress has been achieved in patients with locally advanced SCCA. Still, phase III study by James et al. reported in 2013 showed that prognosis of SCCA patients treated with this regimen can be improved probably due to a better tumor classification, more precise radiological methods, known as "Will Rogers phenomenon".

Based on the above, investigators have designed this phase II trial assessing the feasibility and efficacy of Ezabenlimab (BI 754091) and mDCF chemotherapy combination followed by:

standard chemoradiotherapy in case of low response to induction treatment (<30% by RECIST criteria) or
additional 2 cycles of mDCF and 1 cycle of Ezabenlimab (BI 754091) followed by hypofractionated radiotherapy in case of high response (≥ 30% by RECIST criteria)

in SCCA patients with high-risk locally advanced (stage III) disease.

In summary, the first innovative aspect of this research program is to provide a valuable proof of concept study evaluating the feasibility to combine radiotherapy, chemotherapies (docetaxel, cisplatin and 5-fluorouracil) and Ezabenlimab (BI 754091) in patients with stage III squamous cell anal carcinoma. INTERACT-ION study will provide evidence that Ezabenlimab (BI 754091) acts in synergy with mDCF to improve complete response rate, and both with hypofractionated radiotherapy to improve the disease-free survival enhancing TH1 and CD8 T cell immunity.

ReferenceCitation: Kim S, François E, André T, Samalin E, Jary M, El Hajbi F, Baba-Hamed N, Pernot S, Kaminsky MC, Bouché O, Desrame J, Zoubir M, Ghiringhelli F, Parzy A, De La Fouchardiere C, Smith D, Deberne M, Spehner L, Badet N, Adotevi O, Anota A, Meurisse A, Vernerey D, Taieb J, Vendrely V, Buecher B, Borg C. Docetaxel, cisplatin, and fluorouracil chemotherapy for metastatic or unresectable locally recurrent anal squamous cell carcinoma (Epitopes-HPV02): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2018 Aug;19(8):1094-1106. doi: 10.1016/S1470-2045(18)30321-8. Epub 2018 Jul 2.

family: Kim

full_name: Stefano Kim

given: Stefano

family: François

full_name: Eric François

given: Eric

family: André

full_name: Thierry André

given: Thierry

family: Samalin

full_name: Emmanuelle Samalin

given: Emmanuelle

family: Jary

full_name: Marine Jary

given: Marine

family: El Hajbi

full_name: Farid El Hajbi

given: Farid

family: Baba-Hamed

full_name: Nabil Baba-Hamed

given: Nabil

family: Pernot

full_name: Simon Pernot

given: Simon

family: Kaminsky

full_name: Marie-Christine Kaminsky

given: Marie-Christine

family: Bouché

full_name: Olivier Bouché

given: Olivier

family: Desrame

full_name: Jérôme Desrame

given: Jérôme

family: Zoubir

full_name: Mustapha Zoubir

given: Mustapha

family: Ghiringhelli

full_name: François Ghiringhelli

given: François

family: Parzy

full_name: Aurélie Parzy

given: Aurélie

family: De La Fouchardiere

full_name: Christelle De La Fouchardiere

given: Christelle

family: Smith

full_name: Denis Smith

given: Denis

family: Deberne

full_name: Mélanie Deberne

given: Mélanie

family: Spehner

full_name: Laurie Spehner

given: Laurie

family: Badet

full_name: Nicolas Badet

given: Nicolas

family: Adotevi

full_name: Olivier Adotevi

family: Anota

full_name: Amélie Anota

given: Amélie

family: Meurisse

full_name: Aurélia Meurisse

given: Aurélia

family: Vernerey

full_name: Dewi Vernerey

given: Dewi

ReferenceCitation: Kim S, Meurisse A, Spehner L, Stouvenot M, François E, Buecher B, André T, Samalin E, Jary M, Nguyen T, El Hajbi F, Baba-Hamed N, Pernot S, Kaminsky MC, Bouché O, Desrame J, Zoubir M, Ghiringhelli F, Parzy A, de la Fouchardiere C, Boulbair F, Lakkis Z, Klajer E, Jacquin M, Taieb J, Vendrely V, Vernerey D, Borg C. Pooled analysis of 115 patients from updated data of Epitopes-HPV01 and Epitopes-HPV02 studies in first-line advanced anal squamous cell carcinoma. Ther Adv Med Oncol. 2020 Dec 4;12:1758835920975356. doi: 10.1177/1758835920975356. eCollection 2020.

location_facility: Centre Hospitalier Universitaire de Besançon


title: TALazoparib and Avelumab as Maintenance Therapy in Platinum-Sensitive Metastatic or Locally Advanced URothelial Carcinoma: A Single-arm Phase 2 Trial

acronym: TALASUR

summary: The main objectif is to determine the efficacy of a maintenance treatment combining Talazoparib and Avelumab after platinum-based chemotherapy in patients with locally advanced/metastatic urothelial carcinoma.

lead_sponsor: Centre Francois Baclesse

location_facility:
Centre François baclesse
Centre George-François Leclerc
Centre Antoine Lacassagne
Centre Léon Bérard
Croix Saint-Simon Diaconesses
Institut de Cancérologie de l'Ouest
Centre Eugène Marquis
Centre Jean Perrin
IUCT
CHU Jean Minjoz
Hopital Tenon


title: Real-life Evaluation of the Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection in Patients Receiving Long-term Treatment for Systemic Lupus Erythematosus and/or Gougerot's Disease

acronym: PREPCOV

summary: There is a pandemic in the world by COVID-19. Currently, the pharmacological curative or prophylactic treatments for this infection are not known. Recent studies have suggested that Hydroxy-Chloroquine could be effective in vitro and in vivo against COVID-19. The main objective of this study is to assess in patients with autoimmune disease treated with long course Hydroxy-Chloroquine initiated before the pandemic COVID-19 had an independent protective effect on the risk or the severity of infection with COVID-19.

design_allocation: Non-Randomized

primary_purpose: Other

ReferenceCitation: Liu J, Cao R, Xu M, Wang X, Zhang H, Hu H, Li Y, Hu Z, Zhong W, Wang M. Hydroxychloroquine, a less toxic derivative of chloroquine, is effective in inhibiting SARS-CoV-2 infection in vitro. Cell Discov. 2020 Mar 18;6:16. doi: 10.1038/s41421-020-0156-0. eCollection 2020.

ReferenceCitation: Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum in: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.

family: Zhou

full_name: Fei Zhou

given: Fei

family: Yu

full_name: Ting Yu

given: Ting

family: Du

full_name: Ronghui Du

given: Ronghui

family: Fan

full_name: Guohui Fan

given: Guohui

family: Liu

full_name: Ying Liu

given: Ying

full_name: Zhibo Liu

given: Zhibo

family: Xiang

full_name: Jie Xiang

given: Jie

family: Wang

full_name: Yeming Wang

given: Yeming

family: Song

full_name: Bin Song

given: Bin

family: Gu

full_name: Xiaoying Gu

given: Xiaoying

family: Guan

full_name: Lulu Guan

given: Lulu

family: Wei

full_name: Yuan Wei

given: Yuan

family: Li

full_name: Hui Li

given: Hui

family: Wu

full_name: Xudong Wu

given: Xudong

family: Xu

full_name: Jiuyang Xu

given: Jiuyang

family: Tu

full_name: Shengjin Tu

given: Shengjin

family: Zhang

full_name: Yi Zhang

given: Yi

family: Chen

full_name: Hua Chen

given: Hua

family: Cao

full_name: Bin Cao

journal_name: The Lancet

ReferenceCitation: Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.

name: From the Chinese Center for Disease Control and Prevention, Beijing (Q.L., X.W., L.Z., R.R., N.X., C.L., D.L., J.Z., W.T., L.J., Q.W., R.W., Y.Z., G. Shi, G.F.G., Z.F.), the Hubei Provincial Center for Disease Control and Prevention, Wuhan, Hubei (X.G., Y.T., X.X., Y.W., Q.C., M.L., C.C., R.Y., S.Z., Y. Luo, B.Y.), the World Health Organization Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, University of Hong Kong, Hong Kong (P.W., K.S.M.L., E.H.Y.L., J.Y.W...

title: Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus–Infected Pneumonia

location_facility: Toulouse University Hospital - Rhumatologie

location_facility: University hospital Toulouse - Purpan Médecine interne

location_facility: Toulouse university Hospital - Larrey Dermatologie

location_facility: Joseph Ducuing Hospital - Médecine interne

location_facility: Pitié Salpêtrière Hospital - Médecine interne

location_facility: Haut-Lévêque Hospital - Médecine interne

location_facility: Pitié Salpêtrière Hospital - Hépatologie

location_facility: Haut-Lévêque Hospital - Gastro-entérologie

location_facility: University Hospital of Toulouse - Rangueil Médecine interne


title: Does Optical Coherence Tomography Optimise Results of Stenting of the Left Main Stem

acronym: DOCTORS-LM

summary: The DOCTORS-LM study will investigate the impact of using optical coherence tomography (OCT) to guide the procedure in angioplasty of lesions of the left main stem responsible for myocardial ischemia.

ReferenceCitation: Meneveau N, Souteyrand G, Motreff P, Caussin C, Amabile N, Ohlmann P, Morel O, Lefrançois Y, Descotes-Genon V, Silvain J, Braik N, Chopard R, Chatot M, Ecarnot F, Tauzin H, Van Belle E, Belle L, Schiele F. Optical Coherence Tomography to Optimize Results of Percutaneous Coronary Intervention in Patients with Non-ST-Elevation Acute Coronary Syndrome: Results of the Multicenter, Randomized DOCTORS Study (Does Optical Coherence Tomography Optimize Results of Stenting). Circulation. 2016 Sep 27;134(13):906-17. doi: 10.1161/CIRCULATIONAHA.116.024393. Epub 2016 Aug 29.

name: From Department of Cardiology, EA3920, University Hospital Jean Minjoz, Besançon, France (N.M., N.B., R.C., M.C., F.E., H.T., F.S.); University Hospital Gabriel Montpied, and Université d’Auvergne UMR 6284, Clermont Ferrand, France (G.S., P.M.); Institut Mutualiste Montsouris, Paris, France (C.C., N.A.); Nouvel Hôpital Civil, Strasbourg, France (P.O., O.M.); Centre Hospitalier, Belfort, France (Y.L.); Centre Hospitalier, Chambéry, France (V.D.-G.); Sorbonne Université - Univ Paris 06 (UPMC), ACTION...

family: Meneveau

full_name: Nicolas Meneveau

given: Nicolas

family: Souteyrand

full_name: Geraud Souteyrand

given: Geraud

family: Motreff

full_name: Pascal Motreff

given: Pascal

family: Caussin

full_name: Christophe Caussin

given: Christophe

family: Amabile

full_name: Nicolas Amabile

family: Ohlmann

full_name: Patrick Ohlmann

given: Patrick

family: Morel

full_name: Olivier Morel

given: Olivier

family: Lefrançois

full_name: Yoann Lefrançois

given: Yoann

family: Descotes-Genon

full_name: Vincent Descotes-Genon

given: Vincent

family: Silvain

full_name: Johanne Silvain

given: Johanne

family: Braik

full_name: Nassim Braik

given: Nassim

family: Chopard

full_name: Romain Chopard

given: Romain

family: Chatot

full_name: Marion Chatot

given: Marion

family: Ecarnot

full_name: Fiona Ecarnot

given: Fiona

family: Tauzin

full_name: Hélène Tauzin

given: Hélène

family: Van Belle

full_name: Eric Van Belle

given: Eric

family: Belle

full_name: Loïc Belle

given: Loïc

family: Schiele

full_name: François Schiele

given: François

journal_name: Circulation

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Optical Coherence Tomography to Optimize Results of Percutaneous Coronary Intervention in Patients with Non–ST-Elevation Acute Coronary Syndrome

location_facility: Centre Hospitalier de Chartres - Hôpital Louis Pasteur


title: Host-pathogen Interactions During Paediatric and Adult SARS-CoV-2 Infection (COVID-19)

summary:
The new Severe acute respiratory syndrome coronavirus (SARS-CoV-2) named coronavirus disease 2019 (COVID-19) is currently responsible for a pandemic spread of febrile respiratory infections, responsible for a veritable global health crisis.

In adults, several evolutionary patterns are observed: i) a/pauci-symptomatic forms; ii) severe forms immediately linked to rare extensive viral pneumonia; and iii) forms of moderate severity, some of which progress to secondary aggravation (Day 7-Day 10). Children can be affected, but are more rarely symptomatic and severe pediatric forms are exceptional.

Like some other coronaviruses (SARS-CoV and Middle East respiratory syndrome coronavirus (MERS-CoV)), these differences in clinical expression could be based on a variability in the immunological response, notably either via inhibition of the type I interferon (IFN-I) response, or on the contrary an immunological dysregulation responsible for a "cytokine storm" associated with the aggravation. Little is known about the impact of these innate immune response abnormalities on the adaptive response. In addition, certain genetic factors predisposing to a state of "hyper-fragility" and certain viral virulence factors could also be predictive of the clinical response.

In this context, the main hypothesis is that the virological analysis and the initial biological and immunological profiles are correlated with the initial clinical presentation of COVID-19 infection. In particular, children forms and pauci-symptomatic disease in adults may be linked to a more robust innate immune response, including better production of IFN-I.

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre Hospitalo-Universitaire de Grenoble


title: Embolization of the Middle Meningeal Artery for the Prevention of Chronic Subdural Hematoma Recurrence in High Risk Patients, a Randomized Controlled Trial

acronym: EMPROTECT

summary: Standard of care for the management of symptomatic chronic subdural hematomas (SDHs) is neurosurgical burr-hole evacuation followed by drainage. Post-operative recurrence rates may be as high as 10 to 20 %. In particular, recurrence rate increases with antiplatelet and anticoagulant therapy. Middle meningeal artery (MMA) embolization has been proposed as a novel treatment of chronic SDH. The aim of this study is to assess the efficacy of MMA embolization in reducing the risk of chronic SDH recurrence at 6 months after burr-hole surgery as compared with standard medical post-operative treatment in patients at high risk of post-operative recurrence.

ipd_sharing_description:
Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital d'instruction des armées de Percy


acronym: IMMUNONCOVID

location_facility: Institut de cancérologie Strasbourg Europe (ICANS)

title: A Prospective, Controlled, Randomized, Multicenter Study of the Efficacy of an Autophagy Inhibitor (GNS561), an Anti-NKG2A (Monalizumab) and an Anti-C5aR (Avdoralimab) Compared to the Standard of Care in Patients With Advanced or Metastatic Cancer and SARS-CoV-2 (COVID-19) Infection.

summary:
A prospective, controlled, randomized, multicenter study whose goal is to compare the efficacy of an autophagy inhibitor (GNS561), an anti-NKG2A (monalizumab) and an anti-C5aR (avdoralimab) versus standard of care in patients with advanced or metastatic cancer who have Sars-CoV-2 infection not eligible to a resuscitation unit.

According to their severity level at the time of enrolment, eligible patients will be randomized into 2 different cohorts:

COHORT 1 (mild symptoms or asymptomatic): GNS561 vs anti-NKG2A vs standard of care (randomization ratio 1:1:1).
COHORT 2 (moderate/severe symptoms): anti-C5aR vs standard of care (randomization ratio 1:1).


title: Mise en Place d'un Plan Pharmaceutique Personnalisé Chez Les Patients transplantés rénaux ou hépatiques : Essai randomisé en Cluster de Type Stepped-wedge.

acronym: GREPH

summary: The main objective of the study is to evaluate the impact of the Personalized Pharmaceutical Plan on the therapeutic adherence to immunosuppressive treatments one year after liver or kidney transplantation.

primary_purpose: Supportive Care

ReferenceCitation: Pourrat X, Berthy E, Dupuis A, Barbier L, Buchler M, Guillon LG, Monmousseau F, Ruspini E, Salamé E, Houdard SB, Giraudeau B. Implementing a personalized pharmaceutical plan in kidney or liver transplant patients: study protocol for a stepped-wedge cluster randomized trial (GRePH). Trials. 2021 Nov 8;22(1):782. doi: 10.1186/s13063-021-05749-w.

family: Pourrat

full_name: Xavier Pourrat

given: Xavier

family: Berthy

full_name: Elise Berthy

given: Elise

family: Dupuis

full_name: Antoine Dupuis

given: Antoine

family: Barbier

full_name: Louise Barbier

given: Louise

family: Buchler

full_name: Matthias Buchler

given: Matthias

family: Guillon

full_name: Leslie Grammatico Guillon

given: Leslie Grammatico

family: Monmousseau

full_name: Fanny Monmousseau

given: Fanny

family: Ruspini

full_name: Eric Ruspini

family: Salamé

full_name: Ephrem Salamé

given: Ephrem

family: Houdard

full_name: Solène Brunet Houdard

given: Solène Brunet

family: Giraudeau

full_name: Bruno Giraudeau

given: Bruno

currency_apc_doaj: GBP

journal_name: Trials

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: University Hospital, Tours

location_facility: APHM - Service de Pharmacie Clinique; Hôpital de la Timone

location_facility: CHU-BREST - Pharmacie clinique La Cavale Blanche

location_facility: CHU-Montpellier Service Pharmacie Lapeyronie

location_facility: CHU-STRASBOURG Service Pharmacie, Hôpital Hautepierre

location_facility: CHU-REIMS Service de Pharmacie -Robert Debré

location_facility: APHM Service Pharmacie- Hôpital de la Conception

location_facility: CHU-RENNES Pôle Pharmacie, Unité de pharmacie clinique

intervention_type: Behavioral


title: Ocular Surface in Patients With Soft Contact Lenses

summary:
Contact lenses modify the structure of the tear film by biophysical and biochemical interactions. These changes may explain more common dry eye symptoms and may sometimes cause lens failure or discontinuation.

In recent years, the investigators have various objective non-invasive methods of tear film evaluation such as the non-invasive break up time, interferometry, and tears meniscus height. These measurements are performed in clinical practice during consultation by devices such as LACRYDIAG.

The improvement of lens comfort requires a better knowledge of the ocular surface in patients with contact lenses. But currently none of these objective parameters have been accurately described.

Therefore, the investigators would like to build a database to describe the different parameters of ocular surface in patients with soft contact lenses.

status: Unknown status

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Centre hospitalier national d'ophtalmologie des Quinze-Vingts


title: A Prospective Clinical Study of Biomarkers of Mild Traumatic BRAIN Injury

acronym: BRAINI

summary: Patients with mild traumatic brain injury (mTBI) represent a burden of patients admitted to the emergency department. According to the guidelines, a cerebral CT scan is indicated after mTBI according to the specific conditions. However, variability exists regarding the respect of these CT scan indications, and less than 10% of patients will have visible brain lesions on CT scan. Recently, serum Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) biomarkers have shown ability to differentiate normal and abnormal CT scan findings after mTBI. These encouraging results prompted us to launch a prospective study using automated and quick measurements of GFAP and UCH-L1 biomarkers to validate these findings.

time_perspective: Prospective

ReferenceCitation: Richard M, Lagares A, Bondanese V, de la Cruz J, Mejan O, Pavlov V, Payen JF; BRAINI investigators. Study protocol for investigating the performance of an automated blood test measuring GFAP and UCH-L1 in a prospective observational cohort of patients with mild traumatic brain injury: European BRAINI study. BMJ Open. 2021 Feb 25;11(2):e043635. doi: 10.1136/bmjopen-2020-043635.

family: Richard

full_name: Marion Richard

family: Lagares

full_name: Alfonso Lagares

given: Alfonso

family: Bondanese

full_name: Victor Bondanese

given: Victor

family: de la Cruz

full_name: Javier de la Cruz

given: Javier

family: Mejan

full_name: Odile Mejan

given: Odile

family: Pavlov

full_name: Vladislav Pavlov

given: Vladislav

family: Payen

full_name: Jean-François Payen

given: Jean-François

journal_name: BMJ Open

oa_colors: green gold

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: University Hospital, Grenoble

location_country: France Spain

location_facility: Hôpital Nord Ouest de Villefranche sur Saône


title: "In Population" Study of Medical and Surgical Management of Patients With Brain Metastases

acronym: CEREMET-LR

summary: The integrated cancer research site (SIRIC) of Montpellier proposes to develop a prospective and regional Clinical Database Project and regional biological collection (blood and tumor samples), which is an expanding data collection designed to contribute to a better understand the patient's management with brain metastases including quality of life and neuropsychological/cognitive aspects.

ReferenceCitation: Davis FG, Dolecek TA, McCarthy BJ, Villano JL. Toward determining the lifetime occurrence of metastatic brain tumors estimated from 2007 United States cancer incidence data. Neuro Oncol. 2012 Sep;14(9):1171-7. doi: 10.1093/neuonc/nos152. Epub 2012 Aug 16.

ReferenceCitation: Fox BD, Cheung VJ, Patel AJ, Suki D, Rao G. Epidemiology of metastatic brain tumors. Neurosurg Clin N Am. 2011 Jan;22(1):1-6, v. doi: 10.1016/j.nec.2010.08.007. Review.

ReferenceCitation: Smedby KE, Brandt L, Bäcklund ML, Blomqvist P. Brain metastases admissions in Sweden between 1987 and 2006. Br J Cancer. 2009 Dec 1;101(11):1919-24. doi: 10.1038/sj.bjc.6605373. Epub 2009 Oct 13.

ReferenceCitation: Kocher M, Soffietti R, Abacioglu U, Villà S, Fauchon F, Baumert BG, Fariselli L, Tzuk-Shina T, Kortmann RD, Carrie C, Ben Hassel M, Kouri M, Valeinis E, van den Berge D, Collette S, Collette L, Mueller RP. Adjuvant whole-brain radiotherapy versus observation after radiosurgery or surgical resection of one to three cerebral metastases: results of the EORTC 22952-26001 study. J Clin Oncol. 2011 Jan 10;29(2):134-41. doi: 10.1200/JCO.2010.30.1655. Epub 2010 Nov 1.

name: From the University of Cologne, Cologne; University Hospital, Leipzig, Germany; Azienda Ospedaliera San Giovanni Battista di Torino and University of Torino, Torino; Istituto Nazionale Neurologico Carlo Besto, Milano, Italy; Marmara University Hospital, Istanbul, Turkey; Hospital Universitari Germans Trías, Institut Català d'Oncologia, Badalona, Spain; Centre Haute Energie, Nice; Centre Leon Bérard, Lyon; Centre Eugène Marquis-Rennes, Rennes, France; Maastricht University Medical Centre, Maastricht, the...

family: Kocher

full_name: Martin Kocher

given: Martin

family: Soffietti

full_name: Riccardo Soffietti

given: Riccardo

family: Abacioglu

full_name: Ufuk Abacioglu

given: Ufuk

family: Villà

full_name: Salvador Villà

given: Salvador

family: Fauchon

full_name: Francois Fauchon

given: Francois

family: Baumert

full_name: Brigitta G. Baumert

given: Brigitta G.

family: Fariselli

full_name: Laura Fariselli

given: Laura

family: Tzuk-Shina

full_name: Tzahala Tzuk-Shina

given: Tzahala

family: Kortmann

full_name: Rolf-Dieter Kortmann

given: Rolf-Dieter

family: Carrie

full_name: Christian Carrie

given: Christian

family: Hassel

full_name: Mohamed Ben Hassel

given: Mohamed Ben

family: Kouri

full_name: Mauri Kouri

given: Mauri

family: Valeinis

full_name: Egils Valeinis

given: Egils

family: van den Berge

full_name: Dirk van den Berge

given: Dirk

family: Collette

full_name: Sandra Collette

given: Sandra

full_name: Laurence Collette

given: Laurence

family: Mueller

full_name: Rolf-Peter Mueller

given: Rolf-Peter

journal_name: Journal of Clinical Oncology

oa_host_type: repository

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: American Society of Clinical Oncology (ASCO)

title: Adjuvant Whole-Brain Radiotherapy Versus Observation After Radiosurgery or Surgical Resection of One to Three Cerebral Metastases: Results of the EORTC 22952-26001 Study

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

location_facility: Centre d'Anatomie et Cytologie Pathologiques de Grabels

location_facility: Centre hospitalier régional et universitaire de Montpellier

location_facility: Centre hospitalier régional et universitaire de Nîmes

location_facility: Laboratoire d'anatomo-pathologie de Nîmes


title: Randomized Controlled Trial Evaluating the Impact of Therapeutic Patient Education on the Toxicity of Immune Checkpoint Inhibitors in Oncology

acronym: EDHITO

summary: The aim of this therapeutic education program is to reduce the apparition of immune-related Adverse Event with patients treated with ICI

primary_purpose: Prevention

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility: Centre D'Oncologie Et de Radiotherapie 37


title: MELROSE: Phase 2 Study Evaluating MEchanisms of Resistance on Tumor Tissue and Liquid Biopsy in Patients With EGFR Mutated Nonpretreated Advanced Lung Cancer Receiving OSimErtinib Until and Beyond Radiological Progression : the MELROSE Trial

acronym: MELROSE

summary:
Osimertinib is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that is selective for both EGFR-TKI sensitizing and T790M resistance mutations in patients with non-small-cell lung cancer.

The AURA 3 study (T790M-positive advanced non-small-cell lung cancer in progression after first-line EGFR-TKI therapy, shown that the median duration of progression-free survival was significantly longer with osimertinib than with platinum therapy plus pemetrexed (10.1 months vs. 4.4 months p<0.001).

In addition, clinical data show that patients with mutated EGFR NSCLC receiving osimertinib in first line, presented an objective response rate of 77 % with a disease control rate of 98 % and a median PFS was 19.3 months.

Finally, The FLAURA study randomized phase 3 study clearly demonstrated the superiority of osimertinib compared with erlotinib or gefitinib in EGFR mutated nonpretreated NSCLC (median PFS of 18.9 months versus 10.2 months).

However, several issues remain unknown or debated :

What are the mechanisms of resistance to osimertinib prescribed in first-line?
What are the consequences of prolonged exposure to osimertinib on the expression of markers of response to immunotherapy?
Is there an association between kinetic parameters of ctDNA (circulating tumor DNA) and prediction of response to osimertinib and/ or and prediction of therapeutic escape under osimertinib? In order to respond to all these questions, this phase II trial will be the first to systemically analyze the mechanisms of resistance to Osimertinib based on the analysis of biopsy, and collection of plasma from all patients during the course of treatment.

ReferenceCitation: Bennouna J, Girard N, Audigier-Valette C, le Thuaut A, Gervais R, Masson P, Marcq M, Molinier O, Cortot A, Debieuvre D, Cadranel J, Lena H, Moro-Sibilot D, Chouaid C, Mennecier B, Urban T, Sagan C, Perrier L, Barlesi F, Denis MG. Phase II Study Evaluating the Mechanisms of Resistance on Tumor Tissue and Liquid Biopsy in Patients With EGFR-mutated Non-pretreated Advanced Lung Cancer Receiving Osimertinib Until and Beyond Radiologic Progression: The MELROSE Trial. Clin Lung Cancer. 2020 Jan;21(1):e10-e14. doi: 10.1016/j.cllc.2019.09.007. Epub 2019 Oct 1.

family: Bennouna

full_name: Jaafar Bennouna

given: Jaafar

family: Girard

full_name: Nicolas Girard

given: Nicolas

family: Audigier-Valette

full_name: Clarisse Audigier-Valette

given: Clarisse

family: le Thuaut

full_name: Aurélie le Thuaut

given: Aurélie

family: Gervais

full_name: Radj Gervais

given: Radj

family: Masson

full_name: Philippe Masson

given: Philippe

family: Marcq

full_name: Marie Marcq

given: Marie

family: Molinier

full_name: Olivier Molinier

given: Olivier

family: Cortot

full_name: Alexis Cortot

given: Alexis

family: Debieuvre

full_name: Didier Debieuvre

given: Didier

family: Cadranel

full_name: Jacques Cadranel

given: Jacques

family: Lena

full_name: Hervé Lena

given: Hervé

family: Moro-Sibilot

full_name: Denis Moro-Sibilot

given: Denis

family: Chouaid

full_name: Christos Chouaid

given: Christos

family: Mennecier

full_name: Bertrand Mennecier

given: Bertrand

family: Urban

full_name: Thierry Urban

given: Thierry

family: Sagan

full_name: Christine Sagan

given: Christine

family: Perrier

full_name: Ludivine Perrier

given: Ludivine

family: Barlesi

full_name: Fabrice Barlesi

given: Fabrice

family: Denis

full_name: Marc G. Denis

given: Marc G.

journal_name: Clinical Lung Cancer

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Nantes University Hospital

location_facility: CH DU MOENCHSBERG - Hôpital Emile Muller


title: Simultaneous Portal and Hepatic Vein Embolization Versus Portal Vein Embolization for Hypertrophy of the Future Liver Remnant Before Major Hepatectomy of Non-cirrhotic Liver : a Multicentric Comparative Randomized Phase II Trial

summary: The hypothesis is that liver venous deprivation (LVD) could strongly improve hypertrophy of the future remnant liver (FRL) at 3 weeks, as compared to portal vein embolization (PVE) in patient with liver metastases from colo-rectal origin considered as resectable.

ReferenceCitation: Deshayes E, Piron L, Bouvier A, Lapuyade B, Lermite E, Vervueren L, Laurent C, Pinaquy JB, Chevallier P, Dohan A, Rode A, Sengel C, Guillot C, Quenet F, Guiu B. Study protocol of the HYPER-LIV01 trial: a multicenter phase II, prospective and randomized study comparing simultaneous portal and hepatic vein embolization to portal vein embolization for hypertrophy of the future liver remnant before major hepatectomy for colo-rectal liver metastases. BMC Cancer. 2020 Jun 19;20(1):574. doi: 10.1186/s12885-020-07065-z.

family: Deshayes

full_name: Emmanuel Deshayes

given: Emmanuel

family: Piron

full_name: Lauranne Piron

given: Lauranne

family: Bouvier

full_name: Antoine Bouvier

given: Antoine

family: Lapuyade

full_name: Bruno Lapuyade

given: Bruno

family: Lermite

full_name: Emilie Lermite

given: Emilie

family: Vervueren

full_name: Laurent Vervueren

given: Laurent

family: Laurent

full_name: Christophe Laurent

given: Christophe

family: Pinaquy

full_name: Jean-Baptiste Pinaquy

given: Jean-Baptiste

family: Chevallier

full_name: Patrick Chevallier

given: Patrick

family: Dohan

full_name: Anthony Dohan

given: Anthony

family: Rode

full_name: Agnès Rode

given: Agnès

family: Sengel

full_name: Christian Sengel

given: Christian

family: Guillot

full_name: Chloé Guillot

given: Chloé

family: Quenet

full_name: François Quenet

given: François

family: Guiu

full_name: Boris Guiu

given: Boris

lead_sponsor: University Hospital, Montpellier

location_facility:
Centre Léon Berard
Hospices Civils de Lyon
Institut Gustave Roussy
CHU de Dijon
CHU d'Angers
CHU de Nice
APHP - Cochin hospital
Hôpital Paul Brousse
CHU de Montpellier
CHU de Poitiers
CHU de Grenoble
Bordeaux University Hospital


title: A Randomized Phase III Trial Assessing a Regorafenib-irinotecan Combination (REGIRI) Versus Regorafenib Alone in Metastatic Colorectal Cancer Patients After Failure of Standard Therapies, According to the A/A Genotype of Cyclin D1

acronym: NEXT-REGIRI

summary: Patients with metastatic colorectal cancer (mCRC) who have received all approved standard treatments (except Regorafenib and TAS 102) no longer have treatment options available while maintaining a good performance status which would allow them to receive a new treatment

ReferenceCitation: Samalin E, Bouché O, Thézenas S, Francois E, Adenis A, Bennouna J, Taieb J, Desseigne F, Seitz JF, Conroy T, Galais MP, Assenat E, Crapez E, Poujol S, Bibeau F, Boissière F, Laurent-Puig P, Ychou M, Mazard T. Sorafenib and irinotecan (NEXIRI) as second- or later-line treatment for patients with metastatic colorectal cancer and KRAS-mutated tumours: a multicentre Phase I/II trial. Br J Cancer. 2014 Mar 4;110(5):1148-54. doi: 10.1038/bjc.2013.813. Epub 2014 Jan 9.

family: Samalin

full_name: E Samalin

given: E

family: Bouché

full_name: O Bouché

given: O

family: Thézenas

full_name: S Thézenas

given: S

family: Francois

full_name: E Francois

family: Adenis

full_name: A Adenis

given: A

family: Bennouna

full_name: J Bennouna

given: J

family: Taieb

full_name: J Taieb

family: Desseigne

full_name: F Desseigne

given: F

family: Seitz

full_name: J F Seitz

given: J F

family: Conroy

full_name: T Conroy

given: T

family: Galais

full_name: M P Galais

given: M P

family: Assenat

full_name: E Assenat

family: Crapez

full_name: E Crapez

family: Poujol

full_name: S Poujol

family: Bibeau

full_name: F Bibeau

family: Boissière

full_name: F Boissière

family: Laurent-Puig

full_name: P Laurent-Puig

given: P

family: Ychou

full_name: M Ychou

given: M

family: Mazard

full_name: T Mazard

journal_name: British Journal of Cancer

evidence: open (via page says license)

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

ReferenceCitation: Lu F, Gladden AB, Diehl JA. An alternatively spliced cyclin D1 isoform, cyclin D1b, is a nuclear oncogene. Cancer Res. 2003 Nov 1;63(21):7056-61.

ReferenceCitation: Alt JR, Cleveland JL, Hannink M, Diehl JA. Phosphorylation-dependent regulation of cyclin D1 nuclear export and cyclin D1-dependent cellular transformation. Genes Dev. 2000 Dec 15;14(24):3102-14.

ReferenceCitation: Grothey A, Van Cutsem E, Sobrero A, Siena S, Falcone A, Ychou M, Humblet Y, Bouché O, Mineur L, Barone C, Adenis A, Tabernero J, Yoshino T, Lenz HJ, Goldberg RM, Sargent DJ, Cihon F, Cupit L, Wagner A, Laurent D; CORRECT Study Group. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2013 Jan 26;381(9863):303-12. doi: 10.1016/S0140-6736(12)61900-X. Epub 2012 Nov 22.

location_facility:
Hôpital Saint-Jean
Centre Antoine Lacassagne
Centre Léon Bérard
Centre François Baclesse
Hôpital Pontchaillou
Hôpital Morvan
Hôpital Robert Debré
Hôpital Européen Georges Pompidou
Institut Godinot
Institut Gustave Roussy
Hôpital privé Jean Mermoz
CRLC Val d'Aurelle-Paul Lamarque


title: Evaluation of the Benefits of Decompressive Craniectomy for Severe Traumatic Brain Injury in Children With Refractory Intracranial Hypertension

acronym: RANDECPED

summary:
Severe traumatic brain injury (TBI) is the leading cause of mortality and severe disability in the pediatric population. The prognosis of these patients depends on the severity of the initial lesions but also on the effectiveness of the therapies used to prevent or at least limit secondary lesions mainly intracranial hypertension (HTIC).

The medical therapeutic strategy for the control of HTIC in children with TBI is well codified: starting with hyperosmolar therapy, then hyperventilation and ultimately the use of barbiturates to deepen sedation. However, these therapies are not devoid of adverse effects (hypernatremia, cerebral hypoxemia, systemic vasodilation) and, for some, their efficacy is diminished over time. When these treatments are insufficient to lower intracranial pressure (ICP), decompressive craniectomy is proposed. Decompressive craniectomy is used in a well-coded manner in malignant ischemic stroke in adults.

In TBI, to date, there are two randomized studies in adults and one in children but with a small number of patients, evaluating the benefit of decompressive craniectomy. None of them showed significantly superiority of the surgery compared to the maximal medication treatment on the functional prognosis in the medium term.

However, these studies have many biases, including a significant cross-over from the conservative treatment group to the surgery arm.

Nevertheless, the pediatric literature on the subject seems to yield better results on neurological prognosis in the long term. There are guidelines on the medical management of childhood TBI published by the National Institute of Health in 2012, which emphasize the need for controlled and randomized studies to define the place of decompressive craniectomy in children. That is why the investigators are proposing this national multicentre study.

lead_sponsor: Fondation Lenval

location_facility: Hôpitaux pédiatriques de Nice CHU-Lenval


title: Transcranial Direct Current Stimulation (tDCS) Cost-utility-analysis in Medical Care on Depressive Episode With One Drug Therapy Failure.

acronym: DISCO

summary:
The purpose of this study is to determine the transcranial direct current stimulation (tDCS) cost-utility in the depression therapy.

This is a 3 years medico-economics study with 1 year follow-up period involving patients with 1 or 2 depression treatment(s) failed.

Eligible subject will be randomized in 2 groups, usual care with tDCS cure (arm A) or only usual care (arm B).

ReferenceCitation: Sauvaget A, Lagalice L, Schirr-Bonnans S, Volteau C, Péré M, Dert C, Rivalland A, Tessier F, Lepage A, Tostivint A, Deschamps T, Thomas-Ollivier V, Robin A, Pineau N, Cabelguen C, Bukowski N, Guitteny M, Beslot A, Simons L, Network H, Vanelle JM, D'Urso G, Bulteau S, Riche VP; DISCO investigators group. Cost-utility analysis of transcranial direct current stimulation (tDCS) in non-treatment-resistant depression: the DISCO randomised controlled study protocol. BMJ Open. 2020 Jan 13;10(1):e033376. doi: 10.1136/bmjopen-2019-033376.

family: Sauvaget

full_name: Anne Sauvaget

given: Anne

family: Lagalice

full_name: Lydie Lagalice

given: Lydie

family: Schirr-Bonnans

full_name: Solène Schirr-Bonnans

given: Solène

family: Volteau

full_name: Christelle Volteau

given: Christelle

family: Péré

full_name: Morgane Péré

given: Morgane

family: Dert

full_name: Cécile Dert

given: Cécile

family: Rivalland

full_name: Annabelle Rivalland

given: Annabelle

family: Tessier

full_name: Fabienne Tessier

given: Fabienne

family: Lepage

full_name: Adeline Lepage

given: Adeline

family: Tostivint

full_name: Agathe Tostivint

given: Agathe

family: Deschamps

full_name: Thibault Deschamps

given: Thibault

family: Thomas-Ollivier

full_name: Véronique Thomas-Ollivier

given: Véronique

family: Robin

full_name: Alison Robin

given: Alison

family: Pineau

full_name: Noémie Pineau

given: Noémie

family: Cabelguen

full_name: Clémence Cabelguen

given: Clémence

family: Bukowski

full_name: Nicolas Bukowski

given: Nicolas

family: Guitteny

full_name: Marie Guitteny

given: Marie

family: Beslot

full_name: Auxane Beslot

given: Auxane

family: Simons

full_name: Luc Simons

given: Luc

family: Network

full_name: HUGOPSY Network

given: HUGOPSY

family: Vanelle

full_name: Jean-Marie Vanelle

given: Jean-Marie

family: D'Urso

full_name: Giordano D'Urso

given: Giordano

family: Bulteau

full_name: Samuel Bulteau

given: Samuel

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Toulouse - Jean Jaurès

location_facility: Centre hospitalier Guillaume Regnier Rennes


title: Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU) vs Surgery: A Prospective Randomized Study

summary: This is a multi-center, crossover study with cluster randomization and a planned accrual of 300 patients with diagnosed breast fibroadenoma (One fibroadenoma treated per patient). This is a trial based prospective cost consequence study. Costs will be estimated from the viewpoint of the healthcare system and from the patient's perspective

lead_sponsor: Theraclion

location_facility:
CHU Strasbourg
Hopital Pitié-salpêtrière
Clinique Mutualiste LA SAGESSE
Hopital TENON
Hopital Européen
Hopital Saint Louis
Polyclinique de l'Atlantique
Centre Hospitalier
CHU de Montpellier
American Hospital of Paris
Polyclinique Majorelle
Groupe Hospitaliler Diaconesses


title: A Prospective, Multicentre Phase II Study of the Efficacy of Lenvatinib Combined With Denosumab in the Treatment of Patients With Predominant Bone Metastatic Radioiodine Refractory Differentiated Thyroid Carcinomas (LENVOS)

acronym: LENVOS

summary: This study evaluates the combination of lenvatinib with denosumab in bone-predominant metastatic Radioiodine Refractory Differentiated Thyroid Carcinomas. All patients will receive this combination of treatments.

lead_sponsor: Centre Leon Berard

location_facility: Hospices Civils de Lyon - Groupement Hospitalier Est

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole


title: Toward a Risk-adapted Strategy to Cure Myeloma : An Intensive Program With Lenalidomide, Ixazomib, and Dexamethasone Plus Daratumumab as Extended Induction and Consolidation Followed by Lenalidomide Maintenance in Newly Diagnosed Standard Risk Multiple Myeloma Patients Eligible for Autologous Stem Cell Transplant : a Phase II Study of the Intergroupe Francophone du Myélome (IFM)

summary:
The main objective of this study is to evaluate the minimal residual disease-negativity rate after administration of the combination of Lenalidomide, Ixazomib, Dexamethasone and Daratumumab as induction and consolidation therapy in an intensive program in newly diagnosed standard risk multiple myeloma patients.

For the induction therapy, each patient received 6 cycles of Lenalidomide, Ixazomib, Dexamethasone and Daratumumab, then peripheral blood stem cell harvest, intensification with autologous stem cell transplantation, consolidation therapy and maintenance.

lead_sponsor: University Hospital, Toulouse

location_facility:
CHU de Caen
Hospices Civils de Lyon
CHU de Dijon
CHU de Nantes
CHRU de Lille
CHU de Tours
CHU de Grenoble
CHU Bordeaux
Institut Paoli Calmettes
University Hosptial Toulouse
CHU de Rennes
CHRU de Nancy


title: Automation Oxygen Flow Titration in Spontaneously Breathing Infants Less Than One Year of Age During a First Episode of Bronchiolitis

summary:
The objective of this study is to assess the efficacy of the FreeO2 device in shortening the hospital length of stay during a first episode of hypoxemic bronchiolitis in infants less than 1 year of age.

FreeO2Bronchio study is a multicenter, prospective, controlled, randomized, open-label study.

lead_sponsor: University Hospital, Brest

location_facility: La-Roche-Sur-Yon, Departmental Hospital Center


title: An Intensive Program With Quadruplet Induction and Consolidation Plus Tandem Autologous Stem Cell Transplantation in Newly Diagnosed High Risk Multiple Myeloma Patients: a Phase II Study of the Intergroupe Francophone du Myélome "IFM 2018-04"

summary: According to international guidelines, upfront therapy for transplant eligible myeloma patients should include triplet induction containing proteasome inhibitor and immunomodulatory agent, autologous stem cell transplant, PI+Imid based triplet consolidation and lenalidomide maintenance. Despite this approach, virtually all MM patients experience disease relapse, especially those with High Risk disease defined by adverse cytogenetic abnormalities (i.e. del(17p), or t(14;16) or t(4;14)) detected by FISH and/or SNP arrays. Indeed, HR myeloma is associated with poorer progression free survival and overall survival and frontline therapy should therefore be improved for this subset of HR patients. The primary objective of this prospective multicenter, open label, interventional phase 2 trial is to evaluate the feasibility of an intensive program including quadruplet induction and consolidation, tandem autologous stem cell transplantation and maintenance in newly diagnosed multiple myeloma patients presenting with HR cytogenetic. Quadruplet induction and consolidation include carfilzomib, lenalidomide, dexamethasone and daratumumab. Maintenance will include lenalidomide and daratumumab. Secondary objectives will include efficacy parameters (i.e. response rate, minimal residual disease, safety, progression free survival, overall survival).

ReferenceCitation: Pawlyn C. High-risk myeloma: a challenge to define and to determine the optimal treatment. Lancet Haematol. 2021 Jan;8(1):e4-e6. doi: 10.1016/S2352-3026(20)30361-6. Epub 2020 Dec 22.

family: Pawlyn

full_name: Charlotte Pawlyn

given: Charlotte

journal_name: The Lancet Haematology

location_facility:
CHRU Dijon
CHRU Bretonneau
CHU Toulouse
CHRU - Hôpital de Pontchaillou
CHU de Nantes
CHRU - Hôpitaux de Brabois
CH de Lyon Sud
CHRU - Hôpital A.Michallon
CHU Caen
CHD Vendée
CHRU Hôpital du Haut Lévêque
CHRU - Hôpital Claude Huriez


title: Prospective Multicenter Randomized Controlled Double-blind Label Study of the Prophylaxis of Recurrent Pouchitis After Fecal Microbiota Transplant in UC With Ileo-anal Anastomosis

acronym: POCA

summary:
Ulcerative colitis (UC) is a chronic inflammatory digestive (IBD) disease medically treated with corticosteroids, aminosalicylates, immunomodulators, and biologics. Almost one third of UC patients will require surgical interventions because of fulminant colitis, dysplasia, cancer, or medical refractory diseases. Restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the current standard surgical intervention. Anastomotic leak, pouch failure, pelvic sepsis, and pouch ischemia can occur after the procedure, but the most common long-term complication is pouchitis, an idiopathic inflammatory condition involving the ileal reservoir. Symptoms of pouchitis are increased stool frequency, urgency, incontinence, bloody stools, abdominal or pelvic discomfort, fatigue, malaise, and fever. The prevalence of pouchitis ranges from 23 to 46 %, with an annual incidence up to 40 %. Though the majority of initial cases of pouchitis are easily managed with a short course of antibiotics, in about 5 to 15 % of cases, inflammation of the pouch becomes chronic with very few treatments available.

Fecal microbiota transplantation (FMT) is a novel therapy to transfer normal intestinal flora from a healthy donor to a patient with a medical condition potentially caused by disrupted homeostasis of intestinal microbiota or dysbiosis. FMT has been widely used in refractory Clostridium difficile infection (CDI) and recently it has gained popularity for treatment of inflammatory bowel disease (IBD). Previous studies suggested that manipulating the composition of intestinal flora through antibiotics, probiotics, and prebiotic achieved significant results for treating acute episodes of UC-associated pouchitis. However, currently there is no established effective treatment for chronic antibiotic dependent pouchitis. Our project aims to evaluate the delay of relapse in chronic recurrent pouchitis after FMT versus sham transplantation.

ReferenceCitation: Trang-Poisson C, Kerdreux E, Poinas A, Planche L, Sokol H, Bemer P, Cabanas K, Hivernaud E, Biron L, Flet L, Montassier E, Le Garcasson G, Chiffoleau A, Jobert A, Lepelletier D, Caillon J, Le Pape P, Imbert BM, Bourreille A. Impact of fecal microbiota transplantation on chronic recurrent pouchitis in ulcerative colitis with ileo-anal anastomosis: study protocol for a prospective, multicenter, double-blind, randomized, controlled trial. Trials. 2020 Jun 3;21(1):455. doi: 10.1186/s13063-020-04330-1.

family: Trang-Poisson

full_name: Caroline Trang-Poisson

given: Caroline

family: Kerdreux

full_name: Elise Kerdreux

given: Elise

family: Poinas

full_name: Alexandra Poinas

given: Alexandra

family: Planche

full_name: Lucie Planche

given: Lucie

family: Sokol

full_name: Harry Sokol

given: Harry

family: Bemer

full_name: Pascale Bemer

given: Pascale

family: Cabanas

full_name: Karine Cabanas

given: Karine

family: Hivernaud

full_name: Eliane Hivernaud

given: Eliane

family: Biron

full_name: Laetitia Biron

given: Laetitia

family: Flet

full_name: Laurent Flet

given: Laurent

family: Montassier

full_name: Emmanuel Montassier

given: Emmanuel

family: Le Garcasson

full_name: Ghislaine Le Garcasson

given: Ghislaine

family: Chiffoleau

full_name: Anne Chiffoleau

given: Anne

family: Jobert

full_name: Alexandra Jobert

family: Lepelletier

full_name: Didier Lepelletier

given: Didier

family: Caillon

full_name: Jocelyne Caillon

given: Jocelyne

family: Le Pape

full_name: Patrice Le Pape

given: Patrice

family: Imbert

full_name: Berthe-Marie Imbert

given: Berthe-Marie

family: Bourreille

full_name: Arnaud Bourreille

given: Arnaud

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

repositories_institution:
PubMed Central - Europe PMC
Research Square - Research Square

location_facility: Groupe Hospitalier Sud- Hopital Haut-lévêque


title: Guadecitabine SGI-110 and Donor Lymphocyte Infusions (Dli) After Allogeneic Stem Cell Transplantation (Allo Sct) in Very High Risk MDS or AML Patients

summary: High risk MDS (Myelodysplastic Syndrome) patients will be treated with SGI-110 after Allogeneic Stem Cell Transplantation in the hypothesis that SGI-110 maintenance given early after HSCT can prevent relapse without increasing non-relapse mortality translating in an improved disease-free survival.

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility:
Hôpital Necker
Hôpital St Louis
CHU Toulouse - IUCT Oncopole
Hôpital Archet 1
CHU d'Angers
CHU de Haut-Lévèque
CHU Estaing
Centre Hospitalier Lyon-Sud
CHU Brabois
CHU Nantes
Hôpital Pitié-Salpêtrière
Hôpital St Vincent de Paul


title: Multicentric Study Determining the Benefit of the Use of 3D Models and Tools in Hepatectomy Planning for Hepatocarcinomas

summary: The aim of this study is to assess the benefit of 3D models in the planning of hepatic resection by comparing the changes in the surgical plan based on the analysis of conventional preoperative images (CT-scan and MRI), compared to the surgical plan based on the analysis of 3D reconstruction.

primary_purpose: Diagnostic

ReferenceCitation: Gauss T, Merckx P, Brasher C, Kavafyan J, Le Bihan E, Aussilhou B, Belghiti J, Mantz J. Deviation from a preoperative surgical and anaesthetic care plan is associated with increased risk of adverse intraoperative events in major abdominal surgery. Langenbecks Arch Surg. 2013 Feb;398(2):277-85. doi: 10.1007/s00423-012-1028-3. Epub 2012 Nov 13.

ReferenceCitation: Couinaud C. [Errors in the topographic diagnosis of liver diseases]. Ann Chir. 2002 Jun;127(6):418-30. Review. French.

ReferenceCitation: Mutter D, Dallemagne B, Bailey Ch, Soler L, Marescaux J. 3D virtual reality and selective vascular control for laparoscopic left hepatic lobectomy. Surg Endosc. 2009 Feb;23(2):432-5. doi: 10.1007/s00464-008-9931-y. Epub 2008 Apr 29.

ReferenceCitation: Mutter D, Soler L, Marescaux J. Recent advances in liver imaging. Expert Rev Gastroenterol Hepatol. 2010 Oct;4(5):613-21. doi: 10.1586/egh.10.57. Review.

lead_sponsor: IHU Strasbourg

location_facility: Service de Chirurgie Digestive - Hôpital Beaujon

location_facility: Service de Chirurgie Digestive et Transplantation - Hôpital Claude Huriez

location_facility: Institut de Chirurgie Viscérale - Clinique de l'Orangerie

location_facility: Service de Chirurgie Digestive Hôpital Charles Nicolle - CHU Rouen

location_facility: Chirurgie Digestive, Hépato-bilio-pancréatique et Transplantation - La Pitié Sâlpêtrière

location_facility: Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil

location_facility: Centre Hépato-Biliaire - Hôpital Paul Brousse

location_facility: Chirurgie Viscérale et Digestive - Polyclinique de Gentilly

location_facility: Service de Chirurgie Digestive - CHU Robert Debré

location_facility: Hôpital Henri Mondor - Service de Chirurgie Digestive et Hépatobiliaire -

location_facility: Service de Chirurgie Digestive et Transplantation Hépatique - Hôpital universitaire de la Croix-Rousse

location_facility: Service de Chirurgie Digestive - CH Emile Muller


title: Treatment of Steroid Refractory Gastro-intestinal Acute Graft-versus-Host disEase afteR AllogeneiC Hematopoietic Stem celL Transplantation With fEcal Microbiota tranSfer

acronym: HERACLES

summary: Patients who have a gastrointestinal acute Graft versus host disease (GVHD) received a first-line standard treatment of corticosteroids. For patients who do not respond or progress after an initial response have a high mortality. There is an interest in identifying effective second line therapy for these patients corticosteroid-resistant acute GVHD. Fecal microbiota transfer might be a beneficial treatment in this clinical situation with a poor prognosis and limited therapeutic options.

lead_sponsor: MaaT Pharma

location_country: Italy France Poland

location_facility:
CHU Angers
University Clinical hospital
Hôpital Henri Mondor
CHRU Lille
CHU Limoges
Hôpital Saint Antoine
CHU Strasbourg
Centre Hospitalier Lyon Sud
CHRU Besançon
Gemelli Hospital
Klinika Hematologii i Transplantologii
Public Clinic Hospital
IUCT Oncopole
CHU Nantes
Institut de Cancérologie de la Loire
CHU Amiens


title: Intravenous Subdissociative-dose Ketamine Versus Morphine for Prehospital Analgesia a Randomized Controlled Trial

acronym: KETAMORPH

summary: This is a prospective, randomized, single-blind trial evaluating prehospital patients experiencing moderate to severe acute pain, defined as a numeric rating scale score greater than or equal to 5. Patients will be randomized to receive ketamine at or morphine by intravenous push.

ReferenceCitation: Le Cornec C, Lariby S, Brenckmann V, Hardouin JB, Ecoffey C, Le Pottier M, Fradin P, Broch H, Kabbaj A, Auffret Y, Deciron F, Longo C, Javaudin F, Le Bastard Q, Jenvrin J, Montassier E. Is intravenously administered, subdissociative-dose KETAmine non-inferior to MORPHine for prehospital analgesia (the KETAMORPH study): study protocol for a randomized controlled trial. Trials. 2018 May 2;19(1):260. doi: 10.1186/s13063-018-2634-3.

family: Le Cornec

full_name: Clément Le Cornec

given: Clément

family: Lariby

full_name: Said Lariby

given: Said

family: Brenckmann

full_name: Vivien Brenckmann

given: Vivien

family: Hardouin

full_name: Jean Benoit Hardouin

given: Jean Benoit

family: Ecoffey

full_name: Claude Ecoffey

given: Claude

family: Le Pottier

full_name: Marion Le Pottier

given: Marion

family: Fradin

full_name: Philippe Fradin

given: Philippe

family: Broch

full_name: Hélène Broch

given: Hélène

family: Kabbaj

full_name: Amine Kabbaj

given: Amine

family: Auffret

full_name: Yannick Auffret

given: Yannick

family: Deciron

full_name: Florence Deciron

given: Florence

family: Longo

full_name: Céline Longo

given: Céline

family: Javaudin

full_name: François Javaudin

given: François

family: Le Bastard

full_name: Quentin Le Bastard

given: Quentin

family: Jenvrin

full_name: Joël Jenvrin

given: Joël

location_facility:
University Hospital of Bordeaux
Rennes University Hospital
Hospital of Saint Nazaire
La Roche sur Yon Hospital
Hospital of Chateaubriant
Quimper Hospital
CH de Gonesse
Grenoble University Hospital
Le Mans University Hospital
Tours University Hospital
Angers University Hospital
Nantes University Hospital


title: Changes in Pulse Pressure Variations Induced by Passive Leg Raising Test to Predict Fluid Responsiveness in ICU

acronym: VPP-ImPRoVE

summary:
The passive leg raising (PLR) test is a reversible preload challenge of around 300 mL of blood that can be repeated as frequently as required without infusing a drop of fluid. Two recent meta-analyses of many studies have confirmed the reliability of the PLR test to predict fluid responsiveness in patients with acute circulatory failure. Nevertheless, the effects of the PLR must be assessed by the direct measurement of cardiac output since changes in arterial pressure do not allow the assessment of the PLR hemodynamic effects with reliability. Moreover, cardiac output must be measured continuously and in real time.

In clinical practice, cardiac output measurement can be difficult for different reasons such as the unavailability of the echocardiography machine, or the absence of any continuous cardiac output monitoring technique at the time of acute circulatory failure occurrence.

Recently, it was shown that the decrease in pulse pressure variation (PPV) induced by the mini-fluid challenge (100 mL of colloid solution infused in 1 min) was able to predict fluid responsiveness with reliability in patients ventilated with low tidal volume (<8 mL/kg of ideal body weight).

Therefore, the investigators hypothesize that the changes in PPV induced by PLR test could be able to predict fluid responsiveness with reliability in mechanically ventilated patients with acute circulatory failure.

ReferenceCitation: Monnet X, Marik P, Teboul JL. Passive leg raising for predicting fluid responsiveness: a systematic review and meta-analysis. Intensive Care Med. 2016 Dec;42(12):1935-1947. doi: 10.1007/s00134-015-4134-1. Epub 2016 Jan 29. Review.

family: Monnet

full_name: Xavier Monnet

given: Xavier

family: Marik

full_name: Paul Marik

given: Paul

family: Teboul

full_name: Jean-Louis Teboul

given: Jean-Louis

journal_name: Intensive Care Medicine

ReferenceCitation: Cherpanath TG, Hirsch A, Geerts BF, Lagrand WK, Leeflang MM, Schultz MJ, Groeneveld AB. Predicting Fluid Responsiveness by Passive Leg Raising: A Systematic Review and Meta-Analysis of 23 Clinical Trials. Crit Care Med. 2016 May;44(5):981-91. doi: 10.1097/CCM.0000000000001556. Review.

family: Cherpanath

full_name: Thomas G. V. Cherpanath

given: Thomas G. V.

family: Hirsch

full_name: Alexander Hirsch

given: Alexander

family: Geerts

full_name: Bart F. Geerts

given: Bart F.

family: Lagrand

full_name: Wim K. Lagrand

given: Wim K.

family: Leeflang

full_name: Mariska M. Leeflang

given: Mariska M.

family: Schultz

full_name: Marcus J. Schultz

given: Marcus J.

family: Groeneveld

full_name: A. B. Johan Groeneveld

given: A. B. Johan

journal_name: Critical Care Medicine

ReferenceCitation: Mallat J, Meddour M, Durville E, Lemyze M, Pepy F, Temime J, Vangrunderbeeck N, Tronchon L, Thevenin D, Tavernier B. Decrease in pulse pressure and stroke volume variations after mini-fluid challenge accurately predicts fluid responsiveness†. Br J Anaesth. 2015 Sep;115(3):449-56. doi: 10.1093/bja/aev222. Epub 2015 Jul 6.

family: Mallat

full_name: J. Mallat

given: J.

family: Meddour

full_name: M. Meddour

given: M.

family: Durville

full_name: E. Durville

given: E.

family: Lemyze

full_name: M. Lemyze

family: Pepy

full_name: F. Pepy

given: F.

family: Temime

full_name: J. Temime

family: Vangrunderbeeck

full_name: N. Vangrunderbeeck

given: N.

family: Tronchon

full_name: L. Tronchon

given: L.

family: Thevenin

title: Decrease in pulse pressure and stroke volume variations after mini-fluid challenge accurately predicts fluid responsiveness †

location_facility: Centre Hospitalier de Lens - Anesthésie-Réanimation

location_facility: CHU d'Amiens - Réanimation Cardio-Thoracique-Vasculaire

location_facility: Centre Hospitalier de Lens - Réanimation