title: Musical Intervention in the ICU: Effect on Tolerance and Acceptance of Non-invasive Ventilation

acronym: Mus-IRA

summary: Non-invasive ventilation (NIV) might be associated with anxiety, thus leading to NIV failure, and intubation. Music therapy has been used in various clinical context, including in ICU patients under mechanical ventilation. We aim to evaluate the effect of a musical intervention on respiratory comfort during NIV for acute respiratory failure.

ReferenceCitation: Messika J, Hajage D, Panneckoucke N, Villard S, Martin Y, Renard E, Blivet A, Reignier J, Maquigneau N, Stoclin A, Puechberty C, Guétin S, Dechanet A, Fauquembergue A, Gaudry S, Dreyfuss D, Ricard JD. Effect of a musical intervention on tolerance and efficacy of non-invasive ventilation in the ICU: study protocol for a randomized controlled trial (MUSique pour l'Insuffisance Respiratoire Aigue - Mus-IRA). Trials. 2016 Sep 13;17(1):450. doi: 10.1186/s13063-016-1574-z.

family: Messika

full_name: Jonathan Messika

given: Jonathan

family: Hajage

full_name: David Hajage

given: David

family: Panneckoucke

full_name: Nataly Panneckoucke

given: Nataly

family: Villard

full_name: Serge Villard

given: Serge

family: Martin

full_name: Yolaine Martin

given: Yolaine

family: Renard

full_name: Emilie Renard

given: Emilie

family: Blivet

full_name: Annie Blivet

given: Annie

family: Reignier

full_name: Jean Reignier

given: Jean

family: Maquigneau

full_name: Natacha Maquigneau

given: Natacha

family: Stoclin

full_name: Annabelle Stoclin

given: Annabelle

family: Puechberty

full_name: Christelle Puechberty

given: Christelle

family: Guétin

full_name: Stéphane Guétin

given: Stéphane

family: Dechanet

full_name: Aline Dechanet

given: Aline

family: Fauquembergue

full_name: Amandine Fauquembergue

given: Amandine

family: Gaudry

full_name: Stéphane Gaudry

family: Dreyfuss

full_name: Didier Dreyfuss

given: Didier

family: Ricard

full_name: Jean-Damien Ricard

given: Jean-Damien

journal_name: Trials

title: Effect of a musical intervention on tolerance and efficacy of non-invasive ventilation in the ICU: study protocol for a randomized controlled trial (MUSique pour l’Insuffisance Respiratoire Aigue - Mus-IRA)

location_facility:
Institut Gustave Roussy
Hôpital Louis Mourier
CHD Vendée


title: Postoperative Radiotherapy According to Molecular Analysis of Surgical Margins of Early Stages Oral and Oropharyngeal Squamous Cell Carcinomas: A Prospective Study

summary: There is no consensus on the indication of postoperative radiotherapy for early stages oral and oropharyngeal squamous cell carcinoma with complete pathological resection and no neck node metastasis, but most of the institutions do not give any post-operative treatment. Loco-regional control rates range between 80-85% at five years. Surgical margins molecular analysis for microsatellite instability (MSI) marker could help to select the high-risk patients who should receive postoperative radiotherapy. We expect to include 120 patients in five years and have 60 informative tumors for MSI marker. Patients with positive molecular margins will receive postoperative radiotherapy (50 Gy). Patients with negative molecular margins will not receive radiotherapy.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility:
Institut Gustave Roussy
Hôpital de la Croix Rousse
Centre Alexis Vautrin
Centre Francois Baclesse

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Unknown


title: Clinical Trial to Assess the Tolerance and the Safety of a Duodenal Tube Monitoring the Microcirculation in 10 Critically Ill Patients.

acronym: MC Monitor

summary:
For Intensive Care Units (ICU) patients, Multiple Organ Dysfunction Syndrome (MODS) is a very common complication yielding high morbidity and mortality. Inadequate regional perfusion of certain organs (gut, kidney, liver, etc) often caused by shock is the main cause of MODS. Current practice uses cardiac output data and blood pressure to manage shock but there are still lacks of information about the regional perfusion. This leads to late MODS diagnostics preventing the implementation of adequate treatment.

Gut perfusion monitoring seems to be a good target to assess the microcirculation but, nowadays, no practical methods or devices are available to measure the gut perfusion, and the current monitoring methods are not specific (CO, BP, OPS-SDF, PCO2, etc).

"MC Monitor" trial is a prospective, multi-center pilot study, enrolling 10 patients.

The probe will be used by intensivists on ICU patients with a risk of shock and requiring mechanical ventilation.

The probe will be placed in the patient with an endoscopic procedure by a gastroenterologist (standard procedure for post-pyloric tubes placement). This procedure will be used to assess the status of the gut mucosa prior to the placement of the APD probe.

status: Completed

study_completion_date_type: Actual

lead_sponsor: Advanced Perfusion Diagnostics

location_facility: CHU Estaing - Service réanimation adultes

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Completed


title: Impact of Drainage of Subglottic Secretions on Ventilator-Associated Pneumonia:a Randomised Multicentre Trial

summary: The purpose of this study is to determine whether drainage of subglottic secretions is effective to reduce the incidence of pneumonia acquired under mechanical ventilation in ICU's patients.

design_allocation: Randomized

primary_purpose: Prevention

ReferenceType: derived

ReferenceCitation: Lacherade JC, De Jonghe B, Guezennec P, Debbat K, Hayon J, Monsel A, Fangio P, Appere de Vecchi C, Ramaut C, Outin H, Bastuji-Garin S. Intermittent subglottic secretion drainage and ventilator-associated pneumonia: a multicenter trial. Am J Respir Crit Care Med. 2010 Oct 1;182(7):910-7. doi: 10.1164/rccm.200906-0838OC. Epub 2010 Jun 3.

family: Lacherade

full_name: Jean-Claude Lacherade

given: Jean-Claude

sequence: first

family: De Jonghe

full_name: Bernard De Jonghe

given: Bernard

sequence: additional

family: Guezennec

full_name: Pierre Guezennec

given: Pierre

family: Debbat

full_name: Karim Debbat

given: Karim

family: Hayon

full_name: Jan Hayon

given: Jan

family: Monsel

full_name: Antoine Monsel

given: Antoine

family: Fangio

full_name: Pascal Fangio

given: Pascal

family: Appere de Vecchi

full_name: Corinne Appere de Vecchi

given: Corinne

family: Ramaut

full_name: Cédric Ramaut

given: Cédric

family: Outin

full_name: Hervé Outin

given: Hervé

family: Bastuji-Garin

full_name: Sylvie Bastuji-Garin

given: Sylvie

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: American Journal of Respiratory and Critical Care Medicine

publisher: American Thoracic Society

publisher_dissemination: American Thoracic Society

publisher_group: American Thoracic Society

publisher_normalized: American Thoracic Society

title: Intermittent Subglottic Secretion Drainage and Ventilator-associated Pneumonia

lead_sponsor: Poissy-Saint Germain Hospital

location_facility:
Poissy Saint-Germain Hospital
Avignon Hospital
Poisyy Saint-Germain Hospital
André Mignot Hospital


title: Evaluation of Different Analysis Methods for Circulating Tumor Cells, Circulating Endothelial Cell, and Circulating Tumor DNA in Patient Followed for a Tumoral Pathology

acronym: CTC-CEC-ADN

summary: Fifteen cohorts will be opened. Each cohort will explore one analysis method and/or tumoral type. Up to 50 patient can be included into each cohort.

primary_purpose: Diagnostic

enrollment_type: Anticipated

lead_sponsor: Institut Curie

location_facility:
Institut Curie
Institut Mutualiste Montsouris


title: Benefits of the Endovascular Treatment in the Early Management of Proximal Sylvian Artery Thrombosis in Patients Refractory or Ineligible to Intravenous Fibrinolysis : a Multicenter Controled Randomized Trial

acronym: EASY

summary:
This trial aims at comparing two strategies currently used to address acute ischemic stroke of the middle cerebral artery : medical treatment without endovascular treatment on the one hand, and medical treatment plus endovascular treatment on the other hand. The efficiency of the strategies will be assessed in terms of early neurological clinical recovery.

The study will focus on three particular situations : (1) tandem internal carotid and middle cerebral artery occlusion, (2) situations where patient cannot benefit from fibrinolysis because of high risk of haemorrhage, (3) situations where fibrinolysis is not recommended because of a delay superior to 4.5 hours.

The hypothesis to be tested is that medical approach plus endovascular treatment is superior to medical treatment alone

study_start_date_type: Actual

status: Terminated

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

intervention_type: Other


title: Evaluation of cccDNA and Total HBV DNA Kinetics in Lymphocytes, Total Blood and Serum in Chronic Hepatitis B Patients Treated With Adefovir Dipivoxil and Peg Interferon Alpha 2a

acronym: DNA-EVAL

summary:
Serum HBV DNA is a referent but insufficient marker of therapeutic follow-up in chronic hepatitis B treatment. Intra hepatic cccDNA disappearance reflects HBV eradication in the liver.

Intra lymphocyte cccDNA could be a new marker of HBV eradication after treatment.

The major interest of this marker is that it can be measured by a simple blood test instead of a liver biopsy.

study_type: Observational

time_perspective: Prospective

lead_sponsor: University Hospital, Limoges

location_facility: Service des Maladies Infectieuses et Tropicales


title: Indication and Response to Immunosuppressive Treatment in Membranous Nephropathy : Role of Anti-mouse PLA2R1 ELISA

acronym: SOURIS

summary: Membranous Nephropathy (MN) is an auto-immune kidney disease and a common cause of nephrotic syndrome. About 30% of MN patients progress to end-stage kidney disease (ESKD) while 30% undergo spontaneous remission. The phospholipase A2 receptor (PLA2R1) is the major auto-antigen in idiopathic MN. Anti-PLA2R1 autoantibodies are found during the active phase of MN. Predictors of disease progression include high titers of anti-PLA2R1 autoantibodies and serum creatinine levels at presentation, as well as decline in renal function during the first six months of follow-up. Investigators identified new prognostic factors in a cohort of 41 idiopathic MN patients with nephrotic syndrome and anti-PLA2R1 autoantibodies at the time of presentation. During a follow-up of at least 36 months, 21 patients had a persistent nephrotic syndrome (group A) and 20 showed partial or total remission (group R). We first measured the cross-reactivity of their sera at the time of presentation to human, rabbit and mouse recombinant PLA2R1 by western blot. All patients exhibited reactivity against human and rabbit PLA2R1, but only some of them did against mouse PLA2R1. These results suggest the presence of distinct epitopes that are differentially conserved among PLA2R1 orthologs.Investigators then set-up three parallel ELISAs using human, rabbit and mouse recombinant PLA2R1. All 41 MN patients showed activity in human and rabbit ELISAs at presentation but only 32 of them (78%) in mouse ELISA.They finally analyzed the association between anti-PLA2R1 titers at presentation in the different ELISAs and the subsequent clinical outcome. The mean anti-PLA2R1 activity was significantly different between group A and R in mouse ELISA but not in human and rabbit ELISA. Patients with anti-mouse PLA2R1 activity over 605 RU (relative unit)/ml showed a significantly lower survival without doubling of serum creatinine or ESKD , but patients in the highest tertile of anti-PLA2R1 activity in rabbit and human ELISA did not show a significant increased risk of renal failure progression. The results suggest that the specific detection of particular anti-PLA2R1 autoantibodies using the novel anti-mouse PLA2R1 ELISA can identify MN patients at risk for ESKD. The aim is to confirm these result on a prospective cohort.

primary_purpose: Basic Science

ReferenceCitation: Teisseyre M, Cremoni M, Boyer-Suavet S, Crepin T, Benzaken S, Zorzi K, Esnault V, Brglez V, Seitz-Polski B. Rituximab Immunomonitoring Predicts Remission in Membranous Nephropathy. Front Immunol. 2021 Oct 13;12:738788. doi: 10.3389/fimmu.2021.738788. eCollection 2021.

family: Teisseyre

full_name: Maxime Teisseyre

given: Maxime

family: Cremoni

full_name: Marion Cremoni

given: Marion

family: Boyer-Suavet

full_name: Sonia Boyer-Suavet

given: Sonia

family: Crepin

full_name: Thomas Crepin

given: Thomas

family: Benzaken

full_name: Sylvia Benzaken

given: Sylvia

family: Zorzi

full_name: Kévin Zorzi

given: Kévin

family: Esnault

full_name: Vincent Esnault

given: Vincent

family: Brglez

full_name: Vesna Brglez

given: Vesna

family: Seitz-Polski

full_name: Barbara Seitz-Polski

given: Barbara

currency_apc_doaj: USD

journal_name: Frontiers in Immunology

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

ReferenceCitation: Seitz-Polski B, Dahan K, Debiec H, Rousseau A, Andreani M, Zaghrini C, Ticchioni M, Rosenthal A, Benzaken S, Bernard G, Lambeau G, Ronco P, Esnault VLM. High-Dose Rituximab and Early Remission in PLA2R1-Related Membranous Nephropathy. Clin J Am Soc Nephrol. 2019 Aug 7;14(8):1173-1182. doi: 10.2215/CJN.11791018. Epub 2019 Jul 24.

family: Dahan

full_name: Karine Dahan

given: Karine

family: Debiec

full_name: Hanna Debiec

given: Hanna

family: Rousseau

full_name: Alexandra Rousseau

given: Alexandra

family: Andreani

full_name: Marine Andreani

given: Marine

family: Zaghrini

full_name: Christelle Zaghrini

given: Christelle

family: Ticchioni

full_name: Michel Ticchioni

given: Michel

family: Rosenthal

full_name: Alessandra Rosenthal

given: Alessandra

journal_name: Clinical Journal of the American Society of Nephrology

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Nephrology Department, Nice University Hospital


title: Multicentre Evaluation of Bucco-dental Health in Patients With Schizophrenia in Côte d'Or

acronym: BUCCODOR

summary:
The aim of this study is to know the bucco-dental status of patients with schizophrenia in Côte d'Or.

Participation in this study will last only as long as it takes to:

carry out a bucco-dental examination: evaluation of dental plaque and calculus
take a blood sample to assess needs in vitamin C (only for patients included at DIJON CHU and CHS Chartreuse)
complete a 30-minute questionnaire: clinical data and answers to questions concerning dental hygiene and eating habits.

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility:
CHS La Chartreuse
CH Semur-en-Auxois
CHU de DIJON


title: Criteria for Hospitalization or Outpatient Management of Patients With Pulmonary Embolism, Hestia Rule Versus Simplified PESI Score : an Open-label Controlled Randomized International Trial (HOME-PE)

acronym: HOME-PE

summary:
Several studies have demonstrated the possibility of outpatient management or early discharge for certain patients presenting acute pulmonary embolism (PE), providing a suitable structure is in place.

The approach featured in the most recent guidelines on acute PE of the European Society of Cardiology, refers to an all-cause mortality risk assessment using the Pulmonary Embolism Severity Index (PESI) score or the simplified PESI score (sPESI). The sPESI takes into account demographics (age), patient history (cancer, cardiac or respiratory disease), and clinical data (systolic blood pressure, heart rate, oxygen saturation). Outpatient care is offered to low-risk patients, providing that all the conditions pertaining to start anticoagulant treatment and follow-up at home are met.

An alternative approach based on a list of simple criteria has been developed as the one used in HESTIA study. The main criteria included in the HESTIA rule consist of absence of the following: hemodynamic instability, need for oxygen therapy, high-risk of hemorrhage, renal or liver failure, or other medical or social conditions requiring hospitalization.

The investigators hereby propose comparing these two approaches in an open-label, controlled randomized international trial with blinded adjudication of endpoints.

The main objective is to demonstrate, in normotensive PE patients, that a strategy based on the HESTIA rule compared to a strategy based on the simplified PESI score is at least as safe as regards the 30-day-rate of adverse events (recurrent VTE, major bleeding or death).

The major secondary objectives are to demonstrate, in normotensive PE patients, that a strategy based on the HESTIA rule compared to a strategy based on the simplified PESI score is more effective :

As regards the rate of patients eventually managed as outpatients.
As regards the rate of patients, in theory, eligible for outpatient care,

primary_purpose: Other

ReferenceType: background

ReferenceCitation: Piran S, Le Gal G, Wells PS, Gandara E, Righini M, Rodger MA, Carrier M. Outpatient treatment of symptomatic pulmonary embolism: a systematic review and meta-analysis. Thromb Res. 2013 Nov;132(5):515-9. doi: 10.1016/j.thromres.2013.08.012. Epub 2013 Aug 28. Review.

ReferenceCitation: Zondag W, Kooiman J, Klok FA, Dekkers OM, Huisman MV. Outpatient versus inpatient treatment in patients with pulmonary embolism: a meta-analysis. Eur Respir J. 2013 Jul;42(1):134-44. doi: 10.1183/09031936.00093712. Epub 2012 Oct 25.

ReferenceCitation: Konstantinides SV, Torbicki A, Agnelli G, Danchin N, Fitzmaurice D, Galiè N, Gibbs JS, Huisman MV, Humbert M, Kucher N, Lang I, Lankeit M, Lekakis J, Maack C, Mayer E, Meneveau N, Perrier A, Pruszczyk P, Rasmussen LH, Schindler TH, Svitil P, Vonk Noordegraaf A, Zamorano JL, Zompatori M; Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). 2014 ESC guidelines on the diagnosis and management of acute pulmonary embolism. Eur Heart J. 2014 Nov 14;35(43):3033-69, 3069a-3069k. doi: 10.1093/eurheartj/ehu283. Epub 2014 Aug 29. Erratum in: Eur Heart J. 2015 Oct 14;36(39):2666. Eur Heart J. 2015 Oct 14;36(39):2642.

ReferenceCitation: Aujesky D, Roy PM, Verschuren F, Righini M, Osterwalder J, Egloff M, Renaud B, Verhamme P, Stone RA, Legall C, Sanchez O, Pugh NA, N'gako A, Cornuz J, Hugli O, Beer HJ, Perrier A, Fine MJ, Yealy DM. Outpatient versus inpatient treatment for patients with acute pulmonary embolism: an international, open-label, randomised, non-inferiority trial. Lancet. 2011 Jul 2;378(9785):41-8. doi: 10.1016/S0140-6736(11)60824-6. Epub 2011 Jun 22.

family: Aujesky

full_name: Drahomir Aujesky

given: Drahomir

family: Roy

full_name: Pierre-Marie Roy

given: Pierre-Marie

family: Verschuren

full_name: Franck Verschuren

given: Franck

family: Righini

full_name: Marc Righini

given: Marc

family: Osterwalder

full_name: Joseph Osterwalder

given: Joseph

family: Egloff

full_name: Michael Egloff

given: Michael

family: Renaud

full_name: Bertrand Renaud

given: Bertrand

family: Verhamme

full_name: Peter Verhamme

given: Peter

family: Stone

full_name: Roslyn A Stone

given: Roslyn A

family: Legall

full_name: Catherine Legall

given: Catherine

family: Sanchez

full_name: Olivier Sanchez

given: Olivier

family: Pugh

full_name: Nathan A Pugh

given: Nathan A

family: N'gako

full_name: Alfred N'gako

given: Alfred

family: Cornuz

full_name: Jacques Cornuz

given: Jacques

family: Hugli

full_name: Olivier Hugli

family: Beer

full_name: Hans-Jürg Beer

given: Hans-Jürg

family: Perrier

full_name: Arnaud Perrier

given: Arnaud

family: Fine

full_name: Michael J Fine

given: Michael J

family: Yealy

full_name: Donald M Yealy

given: Donald M

journal_name: The Lancet

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Zondag W, Mos IC, Creemers-Schild D, Hoogerbrugge AD, Dekkers OM, Dolsma J, Eijsvogel M, Faber LM, Hofstee HM, Hovens MM, Jonkers GJ, van Kralingen KW, Kruip MJ, Vlasveld T, de Vreede MJ, Huisman MV; Hestia Study Investigators. Outpatient treatment in patients with acute pulmonary embolism: the Hestia Study. J Thromb Haemost. 2011 Aug;9(8):1500-7. doi: 10.1111/j.1538-7836.2011.04388.x.

ReferenceCitation: Roy PM, Penaloza A, Hugli O, Klok FA, Arnoux A, Elias A, Couturaud F, Joly LM, Lopez R, Faber LM, Daoud-Elias M, Planquette B, Bokobza J, Viglino D, Schmidt J, Juchet H, Mahe I, Mulder F, Bartiaux M, Cren R, Moumneh T, Quere I, Falvo N, Montaclair K, Douillet D, Steinier C, Hendriks SV, Benhamou Y, Szwebel TA, Pernod G, Dublanchet N, Lapebie FX, Javaud N, Ghuysen A, Sebbane M, Chatellier G, Meyer G, Jimenez D, Huisman MV, Sanchez O; HOME-PE Study Group. Triaging acute pulmonary embolism for home treatment by Hestia or simplified PESI criteria: the HOME-PE randomized trial. Eur Heart J. 2021 Aug 31;42(33):3146-3157. doi: 10.1093/eurheartj/ehab373.

name: Emergency Department, CHU Angers, 4 rue Larrey, Angers, France, F-49000

name: Univ. Angers, INSERM, CNRS, MITOVASC, Equipe CARME, SFR ICAT, Angers, France

name: Emergency Department, Cliniques Universitaires Saint-Luc, Brussels, Belgium

name: Emergency Department, University Hospital of Lausanne, Lausanne, Switzerland

name: Department of Medicine – Thrombosis and Hemostasis, DTN, Leiden University Medical Center, Leiden, the Netherlands

name: Computing, Statistics and Public Health & CIC1418, Hôpital Européen Georges Pompidou, APHP, Paris, France

name: Department of Cardiology and Vascular Medicine, CH Sainte Musse – Toulon, Toulon, France

name: Department of Internal Medicine and Chest Disease, CHU Brest, Brest, France

name: EA3878-GETBO, CIC-INSERM1412, Univ-Brest, Brest, France

name: Emergency Department, CHU Rouen, Normandy Univ, UNIROUEN, Rouen, France

name: Emergency Department, Sart Tilman University Hospital, Liège, Belgium

name: Department of Internal Medicine, Rode Kruis Hospital, Beverwijk, DTN, the Netherlands

name: Department of Pneumology and Intensive Care, Hôpital Europeen Georges Pompidou, APHP, Paris, France

name: University of Paris, INSERM UMR-S 1140 Innovaties Therapies in Haemostasis, Paris, France

name: Emergency Department, Hôpital Cochin, APHP, Paris, France

name: Emergency Department, CHU Grenoble Alpes, Grenoble, France

name: HP2 INSERM U 1042 Laboratory, University of Grenoble-Alpes, Grenoble, France

name: Emergency Department, CHU Clermont-Ferrand, University of Clermont Auvergne, Clermont-Ferrand, France

name: Emergency Department, CHU Toulouse, Toulouse, France

name: Internal Medicine Department, HU Paris Nord, Louis Mourier Hospital, APHP, Colombes, France

name: Inserm UMR_S1140 Hemostasis Therapeutical Innovations, University of Paris, Colombes, France

name: Department of Internal Medicine, Tergooi Hospital, Hilversum, the Netherlands

name: Emergency Department, Saint-Pierre Hospital, Brussels, Belgium

name: Vascular Medicine Department, CHU Montpellier, EA2992, CIC 1001, University of Montpellier, Montpellier, France

name: Vascular Medicine Department, CHU Dijon, Dijon, France

name: Department of Cardiology, CH Le Mans, Le Mans, France

name: Emergency Department, Cliniques Universitaires Saint-Luc, UCLouvain, Brussels, Belgium

name: Department of Medicine – Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands

name: Department of Internal Medicine, CHU Charles Nicolle, Rouen, France

name: Normandie University, UNIROUEN, INSERM U1096 EnVI, Rouen, France

name: Department of Internal Medicine, Cochin Hospital, APHP, Paris, France

name: Department of Vascular Medicine, CHU Grenoble Alpes, Grenoble, France

name: University Grenoble Alpes, CNRS / TIMC-IMAG UMR 5525 / Themas, Grenoble, France

name: Vascular Medicine Department, CHU Toulouse, Toulouse, France

name: Emergency Department, CréAk, Louis Mourier Hospital, APHP, University of Paris, Colombes, France

name: Emergency Department, Lapeyronie Hospital, CHU Montpellier, University of Montpellier, Montpellier, France

name: Respiratory Department and Medicine Department, Ramon y Cajal Hospital IRYCIS Alcal de Henares University, Madrid, Spain

name: Pneumology Department and Intensive Care, Hôpital Européen Georges Pompidou, APHP, 20-40 rue Leblanc, Paris, France, F-75908

location_country: Switzerland Netherlands France Belgium Spain

location_facility: Leiden University Medical Center Leiden,


title: A Randomized, Double-blind, Placebo-controlled Phase 2 (2a and 2b) Study to Evaluate the Safety and Efficacy of XAV-19 in Patients With COVID-19 Induced Moderate Pneumonia

acronym: POLYCOR

summary:
Early inhibition of entry and replication of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a very promising therapeutic approach. Polyclonal neutralizing antibodies offers many advantages such as providing immediate immunity, consequently blunt an early pro-inflammatory pathogenic endogenous antibody response and lack of drug-drug interactions1-3.

Because a suboptimal endogenous early antibody response with regard to SARS-CoV-2 replication in severe cases is observed, neutralising antibody treatment can be very interesting for patient with COVID-19 induced moderate pneumonia4,5. Convalescent plasma to treat infected patients is therefore an interesting therapeutic option currently under evaluation. However, the difficulties of collecting plasma and its safety aspects are not adapted to many patients.

A new polyclonal humanized anti-SARS-CoV2 antibodies (XAV-19) is being developed by Xenothera, which can be administered as intravenous treatment. XAV-19 is a heterologous swine glyco-humanized polyclonal antibody (GH-pAb) raised against the spike protein of SARS-CoV-2, inhibiting infection of ACE-2 positive human cells with SARS-CoV-2. Pharmacokinetic and pharmacodynamic studies have been performed in preclinical models including primates and a First In Human study with another fully representative GH-pAb from Xenothera is ongoing in volunteer patients recipients of a kidney graft. These studies indicated that 5 consecutive administrations of GH-pAbs can be safely performed in humans.

The objective of this 2-steps phase 2 randomized double-blind, placebo-controlled study is 1) to define the optimal and safety XAV-19 dose to administrate in patients with COVID-19 induced moderate pneumonia ; 2) to show the clinical benefit of selected dose of XAV-19 when administered to patients with COVID-19 induced moderate pneumonia.

status: Active, not recruiting

ReferenceCitation: Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9:CD013825. doi: 10.1002/14651858.CD013825.pub2. Review.

name: Cochrane Haematology, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

family: Kreuzberger

full_name: Nina Kreuzberger

given: Nina

family: Hirsch

full_name: Caroline Hirsch

given: Caroline

name: Transfusion Research Unit, School of Public Health and Preventive Medicine; Monash University; Melbourne Australia

family: Chai

full_name: Khai Li Chai

given: Khai Li

name: Population Health Sciences, Bristol Medical School; University of Bristol; Bristol UK

family: Tomlinson

full_name: Eve Tomlinson

given: Eve

family: Khosravi

full_name: Zahra Khosravi

given: Zahra

name: Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine; University Hospital Wuerzburg; Wuerzburg Germany

family: Popp

full_name: Maria Popp

given: Maria

family: Neidhardt

full_name: Miriam Neidhardt

given: Miriam

family: Piechotta

full_name: Vanessa Piechotta

given: Vanessa

name: Laboratory of Experimental Immunology, Institute of Virology; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

family: Salomon

full_name: Susanne Salomon

given: Susanne

name: Jon J van Rood Center for Clinical Transfusion Research; Sanquin/Leiden University Medical Center; Leiden Netherlands

family: Valk

full_name: Sarah J Valk

given: Sarah J

family: Monsef

full_name: Ina Monsef

given: Ina

name: Department of Nephrology; Technical University of Munich, School of Medicine, Klinikum rechts der Isar; Munich Germany

family: Schmaderer

full_name: Christoph Schmaderer

given: Christoph

family: Wood

full_name: Erica M Wood

given: Erica M

name: Erasmus Medical Centre; Rotterdam Netherlands

family: So-Osman

full_name: Cynthia So-Osman

given: Cynthia

name: Systematic Review Initiative; NHS Blood and Transplant; Oxford UK

family: Roberts

full_name: David J Roberts

given: David J

family: McQuilten

full_name: Zoe McQuilten

given: Zoe

name: Haematology/Transfusion Medicine; NHS Blood and Transplant; Oxford UK

family: Estcourt

full_name: Lise J Estcourt

given: Lise J

name: Cochrane Cancer, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf; Faculty of Medicine and University Hospital Cologne, University of Cologne; Cologne Germany

family: Skoetz

full_name: Nicole Skoetz

given: Nicole

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Gaborit B, Dailly E, Vanhove B, Josien R, Lacombe K, Dubee V, Ferre V, Brouard S, Ader F, Vibet MA, Le Thuaut A, Danger R, Flet L, Omnes A, Berly L, Chiffoleau A, Jobert A, Duvaux O, Raffi F; POLYCOR Trial Group. Pharmacokinetics and Safety of XAV-19, a Swine Glyco-humanized Polyclonal Anti-SARS-CoV-2 Antibody, for COVID-19-Related Moderate Pneumonia: a Randomized, Double-Blind, Placebo-Controlled, Phase IIa Study. Antimicrob Agents Chemother. 2021 Aug 17;65(9):e0123721. doi: 10.1128/AAC.01237-21. Epub 2021 Aug 17.

name: Department of Infectious Disease, Nantes University Hospital, Nantes, France

name: INSERM CIC1413, Nantes University Hospital, Nantes, France

family: Gaborit

full_name: Benjamin Gaborit

given: Benjamin

name: Clinical Pharmacology Department, CHU Nantes, Nantes, France

family: Dailly

full_name: Eric Dailly

given: Eric

family: Vanhove

name: Laboratoire d’Immunologie, CIMNA, CHU Nantes, Nantes, France

name: Centre de Recherche en Transplantation et Immunologie UMR 1064, INSERM, Université de Nantes, ITUN, CHU Nantes, Nantes, France

name: Institut Pierre Louis d’Epidémiologie et de Santé Publique, Sorbonne Université, INSERM, AP-HP, Hôpital Saint-Antoine, Service des Maladies Infectieuses et Tropicales, Paris, France

name: Service de Maladies Infectieuses et Tropicales, Centre Hospitalier Universitaire d’Angers, Angers, France

name: Virology Laboratory University Hospital, Nantes, France

name: Centre International de Recherche en Infectiologie (CIRI), Inserm 1111, Université Claude Bernard Lyon 1, CNRS, UMR5308, Ecole Normale Supérieure de Lyon, Université Lyon, Lyon, France

name: Département des Maladies Infectieuses et Tropicales, Hospices Civils de Lyon, Lyon, France

name: CHU Nantes, Sponsor Department, Nantes, France

name: CHU Nantes, Pharmacy Department, Nantes, France

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

ReferenceCitation: Gaborit B, Vanhove B, Vibet MA, Le Thuaut A, Lacombe K, Dubee V, Ader F, Ferre V, Vicaut E, Orain J, Le Bras M, Omnes A, Berly L, Jobert A, Morineau-Le Houssine P, Botturi K, Josien R, Flet L, Degauque N, Brouard S, Duvaux O, Poinas A, Raffi F; POLYCOR study group. Evaluation of the safety and efficacy of XAV-19 in patients with COVID-19-induced moderate pneumonia: study protocol for a randomized, double-blinded, placebo-controlled phase 2 (2a and 2b) trial. Trials. 2021 Mar 9;22(1):199. doi: 10.1186/s13063-021-05132-9.

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

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

location_facility:
CHU Strasbourg
CH Le Mans
APHP - Hôpital Avicennes
CH de La Rochelle
CHU Martinique
CHU Nantes
CH René Dubos
CH Avignon
Hospices Civils Lyon
CHRU Lille
Hôpital Saint Antoine
CHU Amiens Picardie
CHU Reims
CHU La Réunion
Hôpital FOCH
Hôpital Privé d'Antony
CHU Limoges
CHRU Nancy
CHU Nîmes
CH Colmar
CHD Vendée
CH de la Côte Basque
CH de Mont de Marzan
CH Sud Francilien
CHU Angers
CH Cornouaille
CH Métropole Savoie
CHR Orléans La Source
CHU Caen
APHP - Hôpital Tenon
CHU Saint Etienne
GHR Mulhouse Sud-Alsace
CHU Nice
CH Bretagne Atlantique


title: Serum Neurofilament-light Chain and Glial Fibrillary Acidic Proten (GFAP) Levels in Patients From the OFSEP Cohort at Different Landmarks of Multiple Sclerosis

acronym: NeurofilMS

summary:
The investigators hypothesize that serum neurofilament-light chain (NfL) levels can provide information about the level of activity and progression of Multiple Sclerosis at different stages and landmarks of the disease.

In addition, Glial Fibrillary Acidic Protein (GFAP) has also been identified as another serum biomarker of disability in MS.

status: Recruiting

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_country: Martinique France

location_facility:
CHU de Strasbourg
CHU d'Amiens
Hopital Henri Mondor
Hopital Pitie Salpetriere
CHU de Tours
CHU de Montpellier
CH de Poissy
CHU de Rennes
CHU de Saint Etienne
CHU de Toulouse
CHU de Nancy
CHU de Potiers
CHU de Bordeaux
CHU de Besancon
CHU de Grenoble
Hopital Timone
CHU de Caen
CHU de Clermont Ferrand
CHU de Dijon
CHU de Lille
CHU de Nice
Fondation Rothschild
CHU de Martinique
CHU de Rouen
Hopital Saint Antoine
CHU de Limoges
CHU de Nimes
CHU de Lyon

intervention_type: Diagnostic Test

status_simplified: Ongoing


type: Other Identifier

title: French Registry for Monitoring Pregnancies and Children of Women With Multiple Sclerosis Within The Observatoire Français de la Sclérose en Plaque (OFSEP) Cohort

acronym: RESPONSE

summary:
The influence of pregnancy on the course of multiple sclerosis (MS) has long been a controversial topic. After the publication of the first large prospective study of pregnancy and MS in 1998, counselling of women with MS has radically changed and many patients have been able to fulfill their desire of motherhood. However, there are still some challenges for the neurologist, who has to face old unanswered questions or new issues, regarding the use of disease modifying drugs (DMDs) in this period of life, effects on the short and long term outcome of the mother (in terms of relapses and disability) and the child, role of breast-feeding and locoregional analgesia.

To set up a national prospective pregnancy registry for patients with MS, nested within the Observatoire Français de la Sclérose en Plaque (OFSEP) cohort, owing to a better knowledge of interactions between MS and pregnancy-related issues (pregnancy itself, locoregional analgesia, breastfeeding, impact of using or stopping DMDs on women/children…)

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre Hospitalier de Versailles Hôpital Andre Mignot


title: Open-label, Randomised and Multi-center Study Evaluating the Efficacy and Safety of an Optimised Background Antiretroviral Regimen (OB) Compared to OB Associated With Enfuvirtide in Previously Treated HIV-1 Infected Patients in Virological Success After a 28-week Induction Treatment With Enfuvirtide Plus OB

summary: This is an open-label, randomized and multi-center study to compare the efficacy and safety of continued enfuvirtide (Fuzeon) plus (+) OB therapy versus OB alone in participants with HIV-1 infection. Participants will receive an initial 28 week induction treatment with enfuvirtide + OB. After 28 weeks participants with a plasma viral load less than or equal to (</=) 400 copies/milliliter (mL) at Week 16 and less than (<) 50 copies/mL at Week 24 will be randomized in the ratio 1:1 to receive either enfuvirtide + OB or OB alone for another 24 weeks (up to Week 52).

lead_sponsor: Hoffmann-La Roche

intervention_type: Drug


title: Study of Immune Thrombocytopenia Pathogenesis: a Multicenter, Open and Controlled Study.

acronym: PTI PARI

summary:
Immune thrombocytopenia (ITP) is an autoimmune disease characterized by a low platelet count responsible for bleedings. The disease is mostly mediated by antiplatelet antibodies produced by specific B cells. However, T cells are also involved but their role is not completely understood.

The aim of this study is to determine the implication of T cells in the pathogenesis of ITP, notably regulatory T cells (Treg, CD4+CD25highFoxp3+), cytotoxic T cells (CD3+CD8+) and T follicular helper cells (TFH, CD3+CD4+CXCR5+PD-1+ICOS+), in blood and in the spleen of primary ITP patients, compared to healthy controls.

location_facility:
CHU de METZ
CHU de Dijon
CHU de Besançon


ReferenceCitation: Ducloy-Bouthors AS, Mercier FJ, Grouin JM, Bayoumeu F, Corouge J, Le Gouez A, Rackelboom T, Broisin F, Vial F, Luzi A, Capronnier O, Huissoud C, Mignon A; FIDEL working group. Early and systematic administration of fibrinogen concentrate in postpartum haemorrhage following vaginal delivery: the FIDEL randomised controlled trial. BJOG. 2021 Oct;128(11):1814-1823. doi: 10.1111/1471-0528.16699. Epub 2021 Apr 7.

name: Pole anesthésie réanimation, maternité Jeanne de Flandre CHRU Lille Lille France

family: Ducloy‐Bouthors

full_name: AS Ducloy‐Bouthors

given: AS

name: Hôpital Antoine BéclèreAssistance Publique Hôpitaux de Paris Clamart France

family: Mercier

full_name: FJ Mercier

given: FJ

name: Inserm U1219, Population Health Bordeaux France

family: Grouin

full_name: JM Grouin

given: JM

name: Hôpital Paule de ViguierCHU Toulouse Toulouse France

family: Bayoumeu

full_name: F Bayoumeu

given: F

family: Corouge

full_name: J Corouge

given: J

family: Le Gouez

full_name: A Le Gouez

given: A

name: Hôpital CochinAssistance Publique Hôpitaux de Paris Paris France

family: Rackelboom

full_name: T Rackelboom

given: T

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

family: Broisin

full_name: F Broisin

name: Maternité Adolphe PinardCHU de Nancy Nancy France

family: Vial

full_name: F Vial

family: Luzi

full_name: A Luzi

family: Capronnier

full_name: O Capronnier

given: O

name: INSERM U846 Stem Cell and Brain Research Institute Bron France

family: Huissoud

full_name: C Huissoud

given: C

family: Mignon

full_name: A Mignon

family: Amar‐Millet

full_name: Annie Amar‐Millet

given: Annie

family: Barre‐Drouard

full_name: Catherine Barre‐Drouard

given: Catherine

family: Bonnet

full_name: Francis Bonnet

given: Francis

family: Bonnin

full_name: Martine Bonnin

given: Martine

family: Boulesteix

full_name: Gilles Boulesteix

given: Gilles

family: Castel

full_name: Adeline Castel

given: Adeline

family: Cattenoz

full_name: Mathilde Cattenoz

given: Mathilde

family: Chassard

full_name: Dominique Chassard

given: Dominique

family: Chonow

full_name: Laurent Chonow

given: Laurent

family: Copin‐Eliat

full_name: Catherine Copin‐Eliat

family: Diemunsch

full_name: Pierre‐Auguste Diemunsch

given: Pierre‐Auguste

family: Fischler

full_name: Marc Fischler

given: Marc

journal_name: BJOG: An International Journal of Obstetrics & Gynaecology

lead_sponsor: Laboratoire français de Fractionnement et de Biotechnologies

location_facility: CHU de Lille, Maternité Jeanne de Flandre

location_facility: Hôpital Saint-Joseph / Pôle Parents - Enfants

location_facility: Maternité Régionale Universitaire de Nancy

location_facility: Les Hôpitaux de Chartres (Hôpital Pasteur)

title: Study on the Efficacy and Safety of a Therapeutic Strategy of PPH Comparing Early Administration of Human Fibrinogen vs Placebo in Patients Treated With IV Prostaglandins Following Vaginal Delivery

summary: The purpose of the study is to assess the benefits of a therapeutic strategy that associates an early administration of human fibrinogen concentrate in the management of PPH on the reduction of bleeding after the initiation of prostaglandins intravenous infusion, following vaginal delivery.


title: F-choline PET in Early Response Assessment for Castration Resistant Prostatic Cancer Treated by Abiraterone Acetate or Enzalutamide

acronym: PRECHOL

summary:
Until today no current diagnostic tool exists to identify an early objective response when patients with castration-resistant prostate cancer were treated by abiraterone acetate or enzalutamide. According to the Prostate Cancer Working Group, the investigators have to wait 12 weeks before the first evaluation. To know soon that the treatment is effective will be decisive for the oncologist, even more in palliative situation where second effects can't be imposed to patients.

In post-docetaxel, the F-choline PET-CT could be used to assess the response of this new therapy. Moreover, the investigators suppose that we can assess an early stage if there is an objective therapeutic response, at 6 weeks of treatment, in order to avoid unnecessarily and expansive treatment.

The aim of this study is to assess if it is possible to determine early (6 weeks of treatment)if a F-choline PET-CT could predict the response to abiraterone acetate or enzalutamide in post-docetaxel.

ReferenceCitation: Jemal A, Siegel R, Ward E, Hao Y, Xu J, Murray T, Thun MJ. Cancer statistics, 2008. CA Cancer J Clin. 2008 Mar-Apr;58(2):71-96. doi: 10.3322/CA.2007.0010. Epub 2008 Feb 20.

ReferenceCitation: Townsend DW. Dual-modality imaging: combining anatomy and function. J Nucl Med. 2008 Jun;49(6):938-55. doi: 10.2967/jnumed.108.051276. Epub 2008 May 15. Review.

ReferenceCitation: Jadvar H. Prostate cancer: PET with 18F-FDG, 18F- or 11C-acetate, and 18F- or 11C-choline. J Nucl Med. 2011 Jan;52(1):81-9. doi: 10.2967/jnumed.110.077941. Epub 2010 Dec 13. Review.

ReferenceCitation: de Jong IJ, Pruim J, Elsinga PH, Vaalburg W, Mensink HJ. 11C-choline positron emission tomography for the evaluation after treatment of localized prostate cancer. Eur Urol. 2003 Jul;44(1):32-8; discussion 38-9.

ReferenceCitation: Scattoni V, Picchio M, Suardi N, Messa C, Freschi M, Roscigno M, Da Pozzo L, Bocciardi A, Rigatti P, Fazio F. Detection of lymph-node metastases with integrated [11C]choline PET/CT in patients with PSA failure after radical retropubic prostatectomy: results confirmed by open pelvic-retroperitoneal lymphadenectomy. Eur Urol. 2007 Aug;52(2):423-9. Epub 2007 Mar 20.

ReferenceCitation: Rinnab L, Mottaghy FM, Blumstein NM, Reske SN, Hautmann RE, Hohl K, Möller P, Wiegel T, Kuefer R, Gschwend JE. Evaluation of [11C]-choline positron-emission/computed tomography in patients with increasing prostate-specific antigen levels after primary treatment for prostate cancer. BJU Int. 2007 Oct;100(4):786-93.

ReferenceCitation: Giovacchini G, Picchio M, Coradeschi E, Bettinardi V, Gianolli L, Scattoni V, Cozzarini C, Di Muzio N, Rigatti P, Fazio F, Messa C. Predictive factors of [(11)C]choline PET/CT in patients with biochemical failure after radical prostatectomy. Eur J Nucl Med Mol Imaging. 2010 Feb;37(2):301-9. doi: 10.1007/s00259-009-1253-3. Epub 2009 Sep 15.

ReferenceCitation: Giovacchini G, Picchio M, Briganti A, Cozzarini C, Scattoni V, Salonia A, Landoni C, Gianolli L, Di Muzio N, Rigatti P, Montorsi F, Messa C. [11C]choline positron emission tomography/computerized tomography to restage prostate cancer cases with biochemical failure after radical prostatectomy and no disease evidence on conventional imaging. J Urol. 2010 Sep;184(3):938-43. doi: 10.1016/j.juro.2010.04.084.

ReferenceCitation: Breeuwsma AJ, Pruim J, van den Bergh AC, Leliveld AM, Nijman RJ, Dierckx RA, de Jong IJ. Detection of local, regional, and distant recurrence in patients with psa relapse after external-beam radiotherapy using (11)C-choline positron emission tomography. Int J Radiat Oncol Biol Phys. 2010 May 1;77(1):160-4. doi: 10.1016/j.ijrobp.2009.04.090. Epub 2009 Sep 23.

ReferenceCitation: Heinisch M, Dirisamer A, Loidl W, Stoiber F, Gruy B, Haim S, Langsteger W. Positron emission tomography/computed tomography with F-18-fluorocholine for restaging of prostate cancer patients: meaningful at PSA < 5 ng/ml? Mol Imaging Biol. 2006 Jan-Feb;8(1):43-8.

ReferenceCitation: Bolla M, de Reijke TM, Van Tienhoven G, Van den Bergh AC, Oddens J, Poortmans PM, Gez E, Kil P, Akdas A, Soete G, Kariakine O, van der Steen-Banasik EM, Musat E, Piérart M, Mauer ME, Collette L; EORTC Radiation Oncology Group and Genito-Urinary Tract Cancer Group. Duration of androgen suppression in the treatment of prostate cancer. N Engl J Med. 2009 Jun 11;360(24):2516-27. doi: 10.1056/NEJMoa0810095.

ReferenceCitation: Bolla M, Collette L, Blank L, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Mattelaer J, Lopez Torecilla J, Pfeffer JR, Lino Cutajar C, Zurlo A, Pierart M. Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): a phase III randomised trial. Lancet. 2002 Jul 13;360(9327):103-6.

ReferenceCitation: Messing EM, Manola J, Yao J, Kiernan M, Crawford D, Wilding G, di'SantAgnese PA, Trump D; Eastern Cooperative Oncology Group study EST 3886. Immediate versus deferred androgen deprivation treatment in patients with node-positive prostate cancer after radical prostatectomy and pelvic lymphadenectomy. Lancet Oncol. 2006 Jun;7(6):472-9.

ReferenceCitation: Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Théodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA; TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1502-12.

ReferenceCitation: Petrylak DP, Tangen CM, Hussain MH, Lara PN Jr, Jones JA, Taplin ME, Burch PA, Berry D, Moinpour C, Kohli M, Benson MC, Small EJ, Raghavan D, Crawford ED. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1513-20.

ReferenceCitation: de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, Chi KN, Jones RJ, Goodman OB Jr, Saad F, Staffurth JN, Mainwaring P, Harland S, Flaig TW, Hutson TE, Cheng T, Patterson H, Hainsworth JD, Ryan CJ, Sternberg CN, Ellard SL, Fléchon A, Saleh M, Scholz M, Efstathiou E, Zivi A, Bianchini D, Loriot Y, Chieffo N, Kheoh T, Haqq CM, Scher HI; COU-AA-301 Investigators. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011 May 26;364(21):1995-2005. doi: 10.1056/NEJMoa1014618.

family: de Bono

full_name: Johann S. de Bono

given: Johann S.

family: Logothetis

full_name: Christopher J. Logothetis

given: Christopher J.

family: Molina

full_name: Arturo Molina

given: Arturo

family: Fizazi

full_name: Karim Fizazi

given: Karim

family: North

full_name: Scott North

given: Scott

family: Chu

full_name: Luis Chu

given: Luis

family: Chi

full_name: Kim N. Chi

given: Kim N.

family: Jones

full_name: Robert J. Jones

given: Robert J.

family: Goodman

full_name: Oscar B. Goodman

given: Oscar B.

suffix: Jr.

family: Saad

full_name: Fred Saad

given: Fred

family: Staffurth

full_name: John N. Staffurth

given: John N.

family: Mainwaring

full_name: Paul Mainwaring

given: Paul

family: Harland

full_name: Stephen Harland

given: Stephen

family: Flaig

full_name: Thomas W. Flaig

given: Thomas W.

family: Hutson

full_name: Thomas E. Hutson

given: Thomas E.

family: Cheng

full_name: Tina Cheng

given: Tina

family: Patterson

full_name: Helen Patterson

given: Helen

family: Hainsworth

full_name: John D. Hainsworth

given: John D.

family: Ryan

full_name: Charles J. Ryan

given: Charles J.

family: Sternberg

title: Abiraterone and Increased Survival in Metastatic Prostate Cancer

ReferenceCitation: Trump DL. Commentary on "Abiraterone in metastatic prostate cancer without previous chemotherapy." Ryan CJ, Smith MR, de Bono JS, Molina A, Logothetis CJ, de Souza P, Fizazi K, Mainwaring P, Piulats JM, Ng S, Carles J, Mulders PF, Basch E, Small EJ, Saad F, Schrijvers D, Van Poppel H, Mukherjee SD, Suttmann H, Gerritsen WR, Flaig TW, George DJ, Yu EY, Efstathiou E, Pantuck A, Winquist E, Higano CS, Taplin ME, Park Y, Kheoh T, Griffin T, Scher HI, Rathkopf DE; COU-AA-302 Investigators, Genitourinary Medical Oncology Program, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA. N Engl J Med 2013;368(2):138-48 [Epub 2012 Dec 10]; N Engl J Med 2013;368(6):584. Urol Oncol. 2013 Nov;31(8):1846. doi: 10.1016/j.urolonc.2013.08.012.

ReferenceCitation: Scher HI, Halabi S, Tannock I, Morris M, Sternberg CN, Carducci MA, Eisenberger MA, Higano C, Bubley GJ, Dreicer R, Petrylak D, Kantoff P, Basch E, Kelly WK, Figg WD, Small EJ, Beer TM, Wilding G, Martin A, Hussain M; Prostate Cancer Clinical Trials Working Group. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol. 2008 Mar 1;26(7):1148-59. doi: 10.1200/JCO.2007.12.4487.

ReferenceCitation: Scher HI, Morris MJ, Basch E, Heller G. End points and outcomes in castration-resistant prostate cancer: from clinical trials to clinical practice. J Clin Oncol. 2011 Sep 20;29(27):3695-704. doi: 10.1200/JCO.2011.35.8648. Epub 2011 Aug 22. Review.

ReferenceCitation: Colloca G. Prostate-specific antigen kinetics as a surrogate endpoint in clinical trials of metastatic castration-resistant prostate cancer: a review. Cancer Treat Rev. 2012 Dec;38(8):1020-6. doi: 10.1016/j.ctrv.2012.03.008. Epub 2012 Apr 12. Review.

ReferenceCitation: Effert PJ, Bares R, Handt S, Wolff JM, Büll U, Jakse G. Metabolic imaging of untreated prostate cancer by positron emission tomography with 18fluorine-labeled deoxyglucose. J Urol. 1996 Mar;155(3):994-8.

ReferenceCitation: Fuccio C, Castellucci P, Schiavina R, Guidalotti PL, Gavaruzzi G, Montini GC, Nanni C, Marzola MC, Rubello D, Fanti S. Role of 11C-choline PET/CT in the re-staging of prostate cancer patients with biochemical relapse and negative results at bone scintigraphy. Eur J Radiol. 2012 Aug;81(8):e893-6. doi: 10.1016/j.ejrad.2012.04.027. Epub 2012 May 22.

ReferenceCitation: Beheshti M, Vali R, Waldenberger P, Fitz F, Nader M, Loidl W, Broinger G, Stoiber F, Foglman I, Langsteger W. Detection of bone metastases in patients with prostate cancer by 18F fluorocholine and 18F fluoride PET-CT: a comparative study. Eur J Nucl Med Mol Imaging. 2008 Oct;35(10):1766-74. doi: 10.1007/s00259-008-0788-z. Epub 2008 May 9.

ReferenceCitation: Fuccio C, Schiavina R, Castellucci P, Rubello D, Martorana G, Celli M, Malizia C, Profitos MB, Marzola MC, Pettinato V, Fanti S. Androgen deprivation therapy influences the uptake of 11C-choline in patients with recurrent prostate cancer: the preliminary results of a sequential PET/CT study. Eur J Nucl Med Mol Imaging. 2011 Nov;38(11):1985-9. doi: 10.1007/s00259-011-1867-0. Epub 2011 Jul 6.

ReferenceCitation: Guide pour la rédaction de protocoles pour la tomographie par émission de positons (TEP) à la [18F]-Fluorocholine ([18F]-FCH). Médecine Nucléaire. 2012;36(6):353-9.

ReferenceCitation: IRSN. Doses délivrées au patient en scannographie et en radiologie conventionelle - Résultats d'une enquête multicentrique en secteur public. Rapport DRPH/SER N°2010-12. 2010.

ReferenceCitation: Daut RL, Cleeland CS, Flanery RC. Development of the Wisconsin Brief Pain Questionnaire to assess pain in cancer and other diseases. Pain. 1983 Oct;17(2):197-210. doi: 10.1016/0304-3959(83)90143-4.

location_facility: Service d'Oncologie Médicale, Institut Daniel Hollard, Groupement Hospitalier Mutualiste

location_facility: Clinique Universitaire de Médecine Nucléaire, CHU de Grenoble

location_facility: Clinique Universitaire d'Oncologie Médicale, CHU de Grenoble


title: Phase II Study: Individualization of Dosage of Irinotecan in the FOLFIRI According to the Genetic Polymorphism of UGT1A1 in the First Line Treatment of Metastatic Colorectal Cancer

acronym: IriGen

summary: This prospective, non randomized multicenter phase II study, will determine the feasibility of individualized dose of irinotecan with the UGT1A1 polymorphism, in patients with metastatic colorectal cancer treated with FOLFIRI.

lead_sponsor: Centre Jean Perrin

location_facility:
Clinique de la Châtaigneraie
Centre Jean Perrin
CHU Estaing


type: EudraCT Number

title: Multicentric, Randomized, Double-blind Versus Placebo Study Evaluating the Efficacy of Treatment With Cholecalciferol (Vitamin D3) for Delaying the Diagnosis of Multiple Sclerosis (MS) After a Clinically Isolated Syndrome (CIS). Comparison of Conversion Rates After 2 Years.

acronym: D-Lay-MS

summary: The main objective of this study is to evaluate the efficacy and tolerance of 2 years of treatment with cholecalciferol (vitamin D3) in patients with a clinically isolated syndrome at high risk for MS (CIS).

location_facility: Fondation Ophtalmologique Adolphe Rothschild

location_facility: CHU de Martinique - Hôpital Pierre Zobda-Quitman

location_facility: MAILLART Elisabeth - La Pitié Salpétrière

location_facility: CHU de Clermont Ferrand - Hôpital Gabriel-Montpied

location_facility: Groupe Hospitalier de l'Institut Catholique de Lille

location_facility: CHU de Montpellier - Hôpital Gui de Chauliac

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CH de Cornouaille - Site Quimper - Hôpital Laennec


title: Assessment of Probe Based Confocal Laser Endo-microscopy for In-vivo Diagnosis of Peripheral Lung Nodules and Masses. "NODIVEM" Study

acronym: NODIVEM

summary:
Solitary pulmonary nodule has become a major challenge in respiratory clinical practice. According to published guidelines, their management often requires close CT follow up, PET CT and invasive procedures to obtain a definite histology. In this context, innovative endoscopic techniques refered as navigational bronchoscopy have proved to be efficient, for the localization and sampling of peripheral lung nodules. However, these techniques are unable to differentiate malignant lesions from benign ones, in-vivo, in real time. Confocal endo-microscopy (CELLVIZIO) of the distal lung - also refered as distal lung probe based confocal laser endo-microscopy or alveolar lung endo-microscopy - allows in-vivo imaging of the distal lung structures in real time.

This prospective trial we will assess confocal endoscopy as a tool to localize the peripheral lung nodules and to differentiate benign from tumoral lesions.

Objective(s)

To demonstrate that confocal endo-microscopy is not inferior to navigational endoscopy for the localisation of peripheral lung nodule
To demonstrate that confocal endoscopy can differentiate benign from malignant tumors

Experimental design:

Multicentric prospective controlled trial, conducted in three academic centers, specialized in interventional bronchoscopy, equipped with both navigational bronchoscopy and probe based confocal endo-microscopy.

Subjects with peripheral lung nodule requiring navigational bronchoscopy will be explored using both Confocal endoscopy AND navigational bronchoscopy. Confocal probe will be inserted in the same catheter as used for the navigational bronchoscopy and confocal images will be recorded before sampling. An ancillary study using topical methylene blue as in situ will be conducted at the Rouen University Center.

An ancillary protocol includes the use of in situ methylene blue deposition and 660 confocal endo-microscopy analysis.

lead_sponsor: University Hospital, Rouen

location_facility:
UHRouen
CHU Toulouse
CHU Saint Etienne


title: Verifying Anal Sphincter Integrity in the Delivery Room Using a Specific Perineal Ultrasound: Impact on Immediate Care and Postpartum Anal Incontinence Rates in Mothers Undergoing Vaginal Birth

acronym: OASIS 2

summary: The main objective of this study is to compare post partum rates of anal sphincter rupture (that is to say the rate of sutures) diagnosed in women with ≥ 2nd degree vaginal tears between two groups: (1) women who are screened just after delivery by performing a perineal ultrasound versus a similar group of women who did not receive screening. This study was not designed to evaluate ultrasound as a diagnostic test but to compare the rate of perineal surgical procedures in each arm.

location_facility: CHU de Montpellier - Hôpital Arnaud de Villeneuve


title: Initial and Long-term Evaluation of Patients With Behavioural Symptoms and Hospitalized in Cognitive and Behavioural Units

summary: Cognitive and behavioral units (CBUs) have been created between 2008 and 2012 French National Alzheimer plan for the management of behavior problems of patients suffering from Alzheimer's disease or other related disorders and necessitating hospitalisation. This Alzheimer plan is promoting the evaluation of these units through the observation of the behavioral and psychological symptoms of dementia (BPSD) evolution. As these units are new, it appears important to assess their long-term impact on patients care.

ReferenceCitation: Pongan E, Freulon M, Delphin-Combe F, Dibie-Racoupeau F, Martin-Gaujard G, Federico D, Waissi A, Richard G, Jacqueline S, Fabre F, Trombert-Paviot B, Krolak-Salmon P, Laurent B, Rouch I. Initial and long-term evaluation of patients with Alzheimer's after hospitalization in cognitive and behavioural units: the EVITAL study design. BMC Psychiatry. 2014 Nov 15;14:308. doi: 10.1186/s12888-014-0308-6.

family: Pongan

full_name: Elodie Pongan

given: Elodie

family: Freulon

full_name: Magalie Freulon

given: Magalie

family: Delphin-Combe

full_name: Floriane Delphin-Combe

given: Floriane

family: Dibie-Racoupeau

full_name: Florence Dibie-Racoupeau

given: Florence

family: Martin-Gaujard

full_name: Géraldine Martin-Gaujard

given: Géraldine

family: Federico

full_name: Denis Federico

given: Denis

family: Waissi

full_name: Aziza Waissi

given: Aziza

family: Richard

full_name: Gaëlle Richard

given: Gaëlle

family: Jacqueline

full_name: Sophie Jacqueline

given: Sophie

family: Fabre

full_name: Florence Fabre

family: Trombert-Paviot

full_name: Béatrice Trombert-Paviot

given: Béatrice

family: Krolak-Salmon

full_name: Pierre Krolak-Salmon

given: Pierre

family: Laurent

full_name: Bernard Laurent

given: Bernard

family: Rouch

full_name: Isabelle Rouch

given: Isabelle

currency_apc_doaj: GBP

journal_name: BMC Psychiatry

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

repository_institution: PubMed Central - Europe PMC

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

title: Initial and long-term evaluation of patients with Alzheimer’s after hospitalization in cognitive and behavioural units: the EVITAL study design

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU de Saint Etienne
CH Saint Jean de Dieu
Hospices Civils de Lyon

intervention_type: Behavioral


title: Mycobacterium Tuberculosis Infection Diagnosis in Patients Above 75 Years Old/ Performance of Interferon Gamma Releasing Assays (IGRA)

acronym: IGRage

summary:
Background: Diagnosis and screening for latent tuberculosis in old patients is of special interest in regards of the morbidity-mortality of this disease in that context.

TB-infection diagnosis based on immunological memory detection can be impaired with age. New blood tests (QFTB-G and T-SPOT.TB) specific for MTB infection have not been evaluated in those old patients.The primary endpoint of this study is the evaluation of the IGRAS for active TB diagnosis in patients above 75 years old.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service de Médecine Interne, Diabete et Maladies Métaboliques

location_facility: Servive de Médecine Interne (Pr S. Herson)


title: Assessment of Cognitive Function After Surgery in Two Types of Anesthesia (General Anesthesia Hypnosedation or Traditional) in Patients Operated for Breast Cancer

acronym: HYPNOSEIN

summary:
The emergence of cognitive disorders after surgery under general anesthesia (GA) is the second leading cause of patient complaints (after dental debris caused by intubation techniques). These cognitive disorders can range from simple reversible confusion (26%) with postoperative cognitive dysfunction without actual recovery (10%).

The hypnosedation is an ancient technique of anesthesia expanding its effects on cognitive function remain to this day unknown, but appear promising.

lead_sponsor: Institut Bergonié

location_facility:
Institut Bergonié
Centre Oscar Lambret
Centre Paul Strauss


title: Phase II Study Evaluating the Combination Pegylated Liposomal Doxorubicin and Dexamethasone for the Treatment of Immunocompetent Patients With Cerebral Lymphoma Relapsed or Refractory to First-line Chemotherapy Containing High Dose Methotrexate (MTXHD) and / or High-dose Cytarabine.

acronym: MYLY

summary:
The protocol is to assess the overall response rate (complete response and partial response) of treatment with non-pegylated liposomal doxorubicin at a dose of 50 mg / m² in combination with dexamethasone in immunocompetent adult patients with primary brain lymphoma large B-cell refractory or relapsed after first-line treatment MTXHD and high-dose cytarabine, excluding strict eye lymphomas.

This is a Phase II, open, prospective, multicenter, non-comparative with direct individual benefit.

lead_sponsor: University Hospital, Brest

location_facility:
Hôpital Pitié Salpêtrière
CHU de Rennes Hôpital Pontchaillou
CHRU de Brest


title: Creation and Setting up of Therapeutic Programs, Interprofessional Communication, Patients' Education and Counseling: a Qualitative Study in 3 Physical Therapy and Rehabilitation Departments

acronym: EMCIQUAL

summary: The purpose of this study is to suggest system for improving patients' management through a detail analysis of physical therapy departments functioning

ReferenceCitation: Coudeyre E, Rannou F, Tubach F, Baron G, Coriat F, Brin S, Revel M, Poiraudeau S. General practitioners' fear-avoidance beliefs influence their management of patients with low back pain. Pain. 2006 Oct;124(3):330-337. doi: 10.1016/j.pain.2006.05.003. Epub 2006 Jun 5.

ReferenceCitation: Coudeyre E, Tubach F, Rannou F, Baron G, Coriat F, Brin S, Revel M, Poiraudeau S. Effect of a simple information booklet on pain persistence after an acute episode of low back pain: a non-randomized trial in a primary care setting. PLoS One. 2007 Aug 8;2(8):e706.

ReferenceCitation: Poiraudeau S, Rannou F, Le Henanff A, Coudeyre E, Rozenberg S, Huas D, Martineau C, Jolivet-Landreau I, Revel M, Ravaud P. Outcome of subacute low back pain: influence of patients' and rheumatologists' characteristics. Rheumatology (Oxford). 2006 Jun;45(6):718-23. Epub 2005 Dec 23.

ReferenceCitation: Ravaud P, Flipo RM, Boutron I, Roy C, Mahmoudi A, Giraudeau B, Pham T. ARTIST (osteoarthritis intervention standardized) study of standardised consultation versus usual care for patients with osteoarthritis of the knee in primary care in France: pragmatic randomised controlled trial. BMJ. 2009 Feb 23;338:b421. doi: 10.1136/bmj.b421.

family: Ravaud

full_name: P Ravaud

given: P

family: Flipo

full_name: R-M Flipo

given: R-M

family: Boutron

full_name: I Boutron

given: I

family: Roy

full_name: C Roy

given: C

family: Mahmoudi

full_name: A Mahmoudi

given: A

family: Giraudeau

full_name: B Giraudeau

given: B

family: Pham

full_name: T Pham

given: T

journal_name: BMJ

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646-56. Epub 2003 Nov 14. Review.

ReferenceCitation: Coudeyre E, Demaille-Wlodyka S, Poizat S, Burton K, Hamonet MA, Revel M, Poiraudeau S. Could a simple educational intervention modify beliefs about whiplash? A preliminary study among professionals working in a rehabilitation ward. Ann Readapt Med Phys. 2007 Oct;50(7):552-7, 545-51. Epub 2007 Jun 18. English, French.

ReferenceCitation: Coudeyre E, Givron P, Vanbiervliet W, Benaïm C, Hérisson C, Pelissier J, Poiraudeau S. [The role of an information booklet or oral information about back pain in reducing disability and fear-avoidance beliefs among patients with subacute and chronic low back pain. A randomized controlled trial in a rehabilitation unit]. Ann Readapt Med Phys. 2006 Nov;49(8):600-8. Epub 2006 May 26. French.

location_facility: CHU Raymond Poincaré- Groupement hospitalier universitaire Ouest


title: Multicentric Evaluation of Two Telematics Systems (PDA Phone and IVS)in Type 2 Diabetics Patients in Failure of Oral Treatment and Having to Start a Treatment by Basal Insulin, Compared to a Conventional Care. National, Multicentric, Comparative Randomized Study

summary:
TELEDIAB-2 is a national, multicenter, controlled, randomised trial. The primary objective of the study is to show that during the initiation of a basal insulin treatment , a computerized decision-making system of adaptation of the insulin, coupled to a distance follow-up (thanks to PDAphone or an interactive vocal server (IVS)), is able to improve metabolic control at the end of 4 mouths as compared with conventional care.

Main judgment criteria: comparison of HbA1c means of the 2 groups profiting from a telemonitoring system compared to the reference group at 4 months.

primary_purpose: Supportive Care

lead_sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

location_facility: Centre Hospitalier de Belfort Montbéliard

location_facility: Centre Hospitalier Intercommunal Alençon-Mamers


title: Laparoscopic Hysterectomy Via a Single Port, Peri-umbilical Technique Versus a Conventional Laparoscopic Technique : a Prospective, Randomized, Multicenter Study Evaluating the Length of Hospital Stay

acronym: HOT

summary: The main objective of the study is the comparison of the effective duration of hospitalization following laparoscopic hysterectomy via a single-port peri-umbilical technique versus an conventional multi-port technique.


title: A Randomized, Open-label Study Evaluating the Antiviral Activity and Safety of 3 Month Fuzeon Induction With an Optimized Background Antiretroviral Regimen Versus OB Alone, in Fuzeon-naive HIV-1 Infected Patients With Virological Failure.

summary:
This 2 arm study will assess the efficacy and safety of a new regimen of Fuzeon

+ optimized background antiretroviral treatment, in Fuzeon-naive HIV-1 infected patients with virological failure. Eligible patients will be randomized to recei ve either new optimized treatment alone, or optimized treatment + Fuzeon 90mg s.

c. twice daily, to determine the effect of 3 month induction with Fuzeon.It will be possible for a patient to receive several additional 3 month periods with F uzeon, in the case of new virological failure. The anticipated time on study tre atment is 3-12 months, and the target sample size is <100 individuals.


title: Therapeutic Alliance is it Associated With Better Compliance Amongst Children With Juvenile Idiopathic Arthritis ?

acronym: ALLIANCE

summary: to evalute if therapeutic alliance is related to adherence in JIA

location_facility:
CHU Angers
Hôpital Bicêtre - APHP
CHRU Brest
CHRU Lille
CHU Nîmes
CHU Poitiers
CHRU Besançon
Hôpital Femme-Mère-Enfant - HCL
Hôpital Nord Franche Comté
CH Mulhouse
CHRU Strasbourg
CHU Bordeaux
CHU Martinique
CHU Dijon
CHU Rennes
CHU Nancy
Hôpital Necker-Enfants Malades - APHP


type: Registry Identifier

title: Effects Of Consumption Of A Highly Mineralized Sodium Bicarbonated Water On Blood Lipid Profile

summary: The aim of the study is to assess the beneficial effect of the short term consumption of the highly mineralized bicarbonated sodium water on blood lipid parameters compared to a low mineralized water.

lead_sponsor: Neptune

location_facility: OPTIMED Naturalpha Biofortis


title: Recto Colonic Endoscopic Mucosal Resection and Polypectomy Under Clopidogrel: the "MEDOC"Study.

acronym: MEDOC

summary:
The endoscopic management of patients on anti platelet agents (APA) is a wide problem, with prevalence of patients on this type of therapy steadily increasing. The benefit / risk balance to stop or continue the APA for the digestive endoscopic procedure confronts us every day in clinical practice to another: the relationship thrombosis / hemorrhage.

Molecules most commonly used today are aspirin and clopidogrel. Current recommendations from the European Society of Gastrointestinal Endoscopy (ESGE) allow the maintenance of aspirin for the polypectomy. Some preliminary data show that the risk of bleeding during endoscopic mucosal resection (EMR) with aspirin is not significantly higher than polypectomy. The concept of polypectomy / EMR without stopping aspirin is progressively accepted and returned gradually to the usual practice. However, these procedures are still not allowed under clopidogrel, or in a dual APA therapy, in the absence of relevant data on the subject in the literature.

It is necessary to achieve a large national multicenter study, to clarify the risk of post recto colonic EMR and polypectomy bleeding in patients under clopidogrel alone or in combination (aspirin and clopidogrel) taking into account the endoscopic preventive measures used in daily practice by endoscopists in expert centers (clip, ligature and loop devices, preventive adrenalin injection).

The aim of the "MEDOC" study is to determine the incidence of immediate and delayed bleeding after colonic polypectomy and / or EMR for patients on clopidogrel.

It is expected in this work an incidence of post-polypectomy bleeding close to that observed during the implementation of these actions in the population without any anti platelet agents.

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Centre Hospitalier Universitaire de Brest

location_facility: Centre Hospitalier Universitaire de Nice


title: EXPLORATION OF THE SOCIAL COGNITION IN ADOLESCENTS WITH A Dissociative Disorder OR AUTISM SPECTRUM

summary:
The schizophrenic disorders and pervasive developmental disorders are neurodevelopmental disorders distinct origin who share common challenges to engage and maintain social relationships and mutual disturbances of affective contact. An important issue of research is to determine the cognitive and brain mechanisms underlying social disability in these two pathologies. Several lines of social cognition have been systematically explored: the perception of emotions, the ability to attribute intentionality and mental states to others (theory of mind), the understanding of social situations in different contexts. We made the observation today that research findings clearly in the field of autism and schizophrenic disorders that converge on common patterns neurocognitive abnormalities. Consequently, many programs support published today use the same therapeutic targets and the same tools in both pathologies. This raises two questions of science: (1) whether the disorders of social cognition reported in the field of autism and schizophrenia are "specific deficit" and not "specific condition", that is to say they are inherent social disadvantage whatever condition or (2) if these disorders of social cognition is a pattern common to autism and schizophrenia but are the result of specific neurocognitive mechanisms and different in each these pathologies. Systematic exploration of these issues is a current issue for understanding the pathophysiological borders between the two neurodevelopmental disorders but also to better define the potential targets of therapeutic strategies, psycho-educational and remediation of disorders of social cognition in autism and schizophrenia.

Main objective: To compare clinical cognitive profiles in adolescents with a schizophrenic disorder, autistic or healthy in the three areas of social cognition: perception of emotions, attribution of intentions to others (theory of mind) and style attribution. We shall constitute three population groups of patients, a group of patients meeting the diagnosis of schizophrenia, a group of patients with autism and a control group (healthy subjects).

location_facility: Centre Hospitalier d'Antibes Juans les Pins


title: VERVE* PROJECT: Study of the Acceptability of a Virtual Reality System on the Cognitive Stimulation of Patients With Alzheimer's Disease or Related Conditions. (*Vanquishing Apathy Through E-inclusion Using Realistic Virtual Environment)

acronym: VERVE

summary:
Virtual environments and information communication technologies (ICT) offer large perspectives in the field of assistive care and rehabilitation.

As potentially endless, the scenarios and environment used using 3D can provide immersive social and interactive context for enjoyable and therapeutic exercises in the aging population. In addition it is also possible to use this type of serious game and scenario in very easy to use devices such as lap top or tablet.

Social exclusion has many causes, Apathy as one of the most common behavioural disturbances found in old adults populations alters significantly social and emotional interaction.

Even though, progress in VR has been made over the past year, the presence of such technology in daily living space is still at the embryonic stage.

The European e-Inclusion policy stresses the importance of ICT in improving the quality of life in potentially disadvantaged groups, including older people and persons.

The VERVE project is developing ICT tools to support the treatment of people who are at risk of social exclusion due to apathy associated with a disability.

As people aged and autonomy worsen fear for safety and comfortable means to maintain social and Health Related Quality of Life (HRQL) status are public health issues.

Moreover, even though older adults would like to perform some activities such as walking in the streets some are reluctant to go out of their homes as the external environment is perceived as potentially unsafe.

Apathy, the most common behavioural symptoms in aging population is characterized by symptoms of reduced initiation and responsiveness to environmental interactions. The syndrome of Apathy takes form of diminished goal-directed behaviour, characterised by emotional blunting, loss of initiative and loss of interest. Apathy along with the nosological characteristics of dementia induces impairment in autonomy level and therefore dependence as cognitive impairments worsened.

The importance of stimulation could be related to the concept of engagement defined as the act of being occupied or involved with an external stimulus. Engaging older person with or without Alzheimer's disease and related disorders in appropriate activities has been shown to yield beneficial HRQL effects such increasing positive emotion, improving cognition, functional autonomy and quality of life.

Accordingly, enriched environments with high definition virtual representation of cities and activities of interest have the potentials not only to encourage patients to get active in a safe and interactive environment but also to create access to enjoyable and stimulating settings for the more severe patients.

The VR setting from VERVE proposed personalised and populated environments available on two different, but interlinked hardware platforms: 1/: standard gaming set-up in the home, nursing home or day hospital therapy group; and 2/ mobile tracked internet devices (e.g.,IPad). The system will ensure maximum openness and dissemination by using 3D Web technologies.

primary_purpose: Health Services Research

location_facility:
EHPAD Valrose
EHPAD Villa Hélios Saint Jean
CHU de Nice


acronym: TOCIDYS

location_facility: Service de rhumatologie, Hôpital Lariboisière

location_facility: Service de Rhumatologie, Groupe Hospitalier Pellegrin

location_facility: Service de rhumatologie, Hopital Edouard Herriot, HCL

source: euctr

title: TREATMENT OF FIBROUS DYSPLASIA OF BONE WITH TOCILIZUMAB AMONG PATIENTS WHO DO NOT RESPOND TO BISPHOSPHONATES. THE TOCIDYS TRIAL.

summary: Bone pain due to fibrous dysplasia of bone is usually treated with bisphosphonates. A small proportion of patients fail to respond adequately. Mutated bone cells produce large amounts of Interleukin-6 (IL-6), with increased bone resorption as a result. Inhibition of IL-6 may be of interest to reduce bone resorption and therefore bone pain. TOCIDYS is a placebo-controlled randomized cross-over trial to test the hypothesis that tocilizumab can reduce bone resorption in those patients with fibrous dysplasia who have already received bisphosphonates.


title: Assessment of Autonomic Neuronal Changes During Moderate Rise of Intracranial Pressure in Human

acronym: CESNA

summary: The purpose of this project is to determine during moderate rise of intracranial pressure (ICP) in awake patient, the change in autonomic function and its influence on cerebral and systemic haemodynamics.

lead_sponsor: University Hospital, Toulouse

location_facility:
University Hospital
University Hospital Toulouse
University Hospital of Toulouse


title: Incidence of Macular Edema After Panretinal Photocoagulation (PRPC) Performed in a Single Session Versus Four Sessions in Diabetic Patients.

acronym: Pascal

summary: The aim of this study is to show that PRPC performed in a single session using a Pascal laser leads to better management of the disease (better rate of regression of neovessels, lower risk of a loss of visual acuity in the long term related to macular edema), a saving of time and better comfort for both patient and doctor.

location_facility:
CHU de la Croix Rousse
CHU Dijon
Hôpital Lariboisière


title: Development of the Glycemic Control Algorithm, in Prandial and Physical Effort Situations.

summary:
The main objective is to assess if the Diabeloop algorithm provides better glycemic control than a "manual" usual algorithm of patients with type 1 diabetes treated by insulin pump during meals, and during activity qualified "moderate" to "severe" by the patients.

The study will be conducted in 18 patients. The investigation centers are: CHSF (for Diabeloop algorithm test during activity), CHU of Grenoble and CHU of Toulouse (for Diabeloop algorithm test during meals.

location_facility:
University Hospital of Toulouse
University Hospital of Grenoble
Centre Hospitalier Sud Francilien


title: Open Trial, Not Randomized Study Evaluating the Efficacy and the Tolerance of RD94 in Patients Needing Endodontic Care, Medical Device Class III

summary:
TRIAL TITLE Open trial, not randomized study evaluating the efficacy and the tolerance of RD94 in patients needing endodontic care, medical device class III.

SPONSOR:

SEPTODONT, 58 rue de Pont de Créteil, 94107 Saint Maur des Fossés cedex Tel : + 33 1-49-76-74-26, Fax. : + 33 1- 49-76-71-91

Reference protocol: 09/001

PRODUCT NAME: Biodentine™ (RD94)

MEDICAL DEVICE:

Class: Bioactive dental substitute (Tricalcium silicate) Dose: not applicable Application : one single time

DEVELOPMENTAL PHASE: not applicable (medical device class III)

lead_sponsor: Ascopharm Groupe Novasco

location_facility: Cabinet de Chirurgie Dentaire rue Saint Didier

location_facility: Service d'endodontie de la Pitié Salpêtrière Hôpital de la Pitié Salpêtrière

location_facility: Service d'Odontologie Hôpital Rothschild


title: Phase II Open 24 Weeks Study to Evaluate Effect and Safety of Tocilizumab as the First Line Therapy in Subjects With Polymyalgia Rheumatica (PMR)

acronym: TENOR

summary:
Phase 1:

Patients are treated with infusions of Tocilizumab (TCZ) for 3 months. Clinical evaluation is performed using PMR-AS.

The PMR-AS is computed by summing the 5 variables after multiplying by 0.1 for weighting purposes: PMR-AS (activity scale = AS) = C reactive protein (CRP) (mg/dl) + patient scale (VASp) (0-10 scale) + physician scale (VASph) (0-10 scale) + morning stiffness(MST) [min]×0.1) + elevation of upper limbs (EUL) (0-3 scale).

At the end of the phase 1,the patients stop TCZ and entered in phase 2 at week 12.

Phase 2:

All the patients are included in the phase 2 and treated with glucocorticoid (GC)for 3 months. Two arms are possible according to the PMR-AS. Either the classical GC treatment (0.3mg/kg), either a low dose group of GC(0.15mg/kg) .

ReferenceCitation: Carvajal Alegria G, Garrigues F, Bettacchioli E, Loeuille D, Saraux A, Cornec D, Devauchelle-Pensec V, Renaudineau Y. Tocilizumab controls bone turnover in early polymyalgia rheumatica. Joint Bone Spine. 2021 May;88(3):105117. doi: 10.1016/j.jbspin.2020.105117. Epub 2020 Dec 7.

family: Carvajal Alegria

full_name: Guillermo Carvajal Alegria

given: Guillermo

family: Garrigues

full_name: Florent Garrigues

given: Florent

family: Bettacchioli

full_name: Eleonore Bettacchioli

given: Eleonore

family: Loeuille

full_name: Damien Loeuille

given: Damien

family: Saraux

full_name: Alain Saraux

given: Alain

family: Cornec

full_name: Divi Cornec

given: Divi

family: Devauchelle-Pensec

full_name: Valérie Devauchelle-Pensec

given: Valérie

family: Renaudineau

full_name: Yves Renaudineau

given: Yves

journal_name: Joint Bone Spine

ReferenceCitation: Laporte JP, Garrigues F, Huwart A, Jousse-Joulin S, Marhadour T, Guellec D, Cornec D, Devauchelle-Pensec V, Saraux A. Localized Myofascial Inflammation Revealed by Magnetic Resonance Imaging in Recent-onset Polymyalgia Rheumatica and Effect of Tocilizumab Therapy. J Rheumatol. 2019 Dec;46(12):1619-1626. doi: 10.3899/jrheum.180958. Epub 2019 Mar 15.

family: Laporte

full_name: Jean-Patrick Laporte

given: Jean-Patrick

family: Huwart

full_name: Anaïs Huwart

given: Anaïs

family: Jousse-Joulin

full_name: Sandrine Jousse-Joulin

given: Sandrine

family: Marhadour

full_name: Thierry Marhadour

given: Thierry

family: Guellec

full_name: Dewi Guellec

given: Dewi

journal_name: The Journal of Rheumatology

oa_host_type: publisher

evidence: open (via free pdf)

publisher: The Journal of Rheumatology

publisher_dissemination: The Journal of Rheumatology

publisher_group: The Journal of Rheumatology

publisher_normalized: The Journal of Rheumatology

ReferenceCitation: Devauchelle-Pensec V, Berthelot JM, Cornec D, Renaudineau Y, Marhadour T, Jousse-Joulin S, Querellou S, Garrigues F, De Bandt M, Gouillou M, Saraux A. Efficacy of first-line tocilizumab therapy in early polymyalgia rheumatica: a prospective longitudinal study. Ann Rheum Dis. 2016 Aug;75(8):1506-10. doi: 10.1136/annrheumdis-2015-208742. Epub 2016 Feb 29.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

location_facility:
CHR d'Orléans
Nantes University Hospital
Brest University Hospital


title: National Survey on GERD Patients (Adults and Children)

acronym: RGO à trav

summary: To describe GERD digestive expression according to ages: - children (from 0 to 23 months) and (24 months and more)- adults (from 18 to 29 years old), (from 30 to 39 years old), (from 40 to 49 years old), (from 50 to 59 years old), (more than 60 years old)

time_perspective: Cross-Sectional

lead_sponsor: AstraZeneca


title: Phase I Trial of Afatinib in Combination With 3 Weekly Trastuzumab in Patients With Tumours Overexpressing HER2. Once the MTD of Afatinib With 3 Weekly Trastuzumab Was Established the Safety of This Dose Will be Assessed Also in Combination With Weekly Trastuzumab.

summary: The aim of the study is to determine the Maximum Tolerated Dose (MTD) of afatinib in combination with 3-weekly trastuzumab in HER2 overexpressing cancer and to assess the efficacy of afatinib given at the MTD dosage, with 3-weekly trastuzumab in HER2 overexpressing metastatic breast cancer.

lead_sponsor: Boehringer Ingelheim

location_facility:
INS Claudius Regaud
CTR Georges-François Leclerc
CTR René Gauducheau, Onco, St Herblain


acronym: HYDRAREA

summary: The aim of this study is to compare bicarbonates versus saline for prevention of contrast induced acute kidney injury in critically ill patients.

lead_sponsor: University Hospital, Caen

location_facility:
Intensive care unit
Surgical Intensive Care Unit
Medical Intensive Care Unit


acronym: LYLO

summary: Alzheimer's disease (AD) has a prolonged prodromal phase before the stage of dementia. Subtle executive cognitive function deficits can be detected at this early pre-dementia phase, more than 10 years before dementia. Among them, the digit symbol substitution task (DSST) has been shown to be altered very early, up to 13 years before dementia. This test, as many others executive function tests, requires a fine control of visuomotor coordination. Like executive functions, eye movements, particularly voluntary-guided saccades, are under the control of the frontal lobe and fronto-parietal networks. Previous studies have shown a deterioration of voluntary saccades in AD using various paradigms. There are no data in prodromal AD, although the pathological process of the disease affects very early brain structures implicated in saccades execution (eg. caudate nucleus and pre-cuneus).

lead_sponsor: University Hospital, Bordeaux

location_facility:
Lyon UniversityHospital
AP-HM
CHU de Bordeaux Hôpital Haut Lévêque


title: Living Conditions and Breast Cancer

summary: The main objective of this study is to estimate of the link (odds ratio) between the precariousness defined by the score SPICE (2 groups: precarious and insecure) and stage at diagnosis (2 groups: CAS: stages 1 or 2 the "good prognosis "versus the witnesses: stage 3 or 4 bad prognosis).

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: IURC - Laboratoire de Biostatistique d'Epidémiologie et de Recherche Clinique


ReferenceCitation: Thibault G, Paintaud G, Legendre C, Merville P, Coulon M, Chasseuil E, Ternant D, Rostaing L, Durrbach A, Di Giambattista F, Büchler M, Lebranchu Y. CD25 blockade in kidney transplant patients randomized to standard-dose or high-dose basiliximab with cyclosporine, or high-dose basiliximab in a calcineurin inhibitor-free regimen. Transpl Int. 2016 Feb;29(2):184-95. doi: 10.1111/tri.12688. Epub 2015 Oct 8.

name: Laboratoire d'Immunologie; Bretonneau Hospital; CHRU de Tours; CNRS; GICC UMR 7292; Université François-Rabelais de Tours; Tours France

family: Thibault

full_name: Gilles Thibault

given: Gilles

name: Laboratoire de Pharmacologie-Toxicologie; Bretonneau Hospital; CHRU de Tours; CNRS; GICC UMR 7292; Université François-Rabelais de Tours; Tours France

family: Paintaud

full_name: Gilles Paintaud

name: Service de Nephrologie-Transplantation; Hôpital Necker; Assistance Publique-Hôpitaux de Paris; Université Paris Descartes; INSERM U 845; Paris France

family: Legendre

full_name: Christophe Legendre

given: Christophe

name: Department of Nephrology, Transplantation and Dialysis; CHU Bordeaux; Pellegrin Hospital; UMR-CNRS 5164; Bordeaux University; Bordeaux France

family: Merville

full_name: Pierre Merville

given: Pierre

family: Coulon

full_name: Maxime Coulon

given: Maxime

family: Chasseuil

full_name: Elodie Chasseuil

given: Elodie

family: Ternant

full_name: David Ternant

given: David

name: Department of Nephrology, Dialysis and Organ Transplantation; Rangueil Hospital; Toulouse France

family: Rostaing

full_name: Lionel Rostaing

given: Lionel

name: Department of Nephrology; INSERM UMR 1197; Kremlin Bicetre Hospital; Le Kremlin-Bicêtre France

family: Durrbach

full_name: Antoine Durrbach

given: Antoine

name: Novartis Pharma SAS; Rueil-Malmaison France

family: Di Giambattista

full_name: Fabienne Di Giambattista

given: Fabienne

name: Department of Nephrology and Clinical Immunology; Bretonneau Hospital; CHRU de Tours; EA4245, Université François-Rabelais de Tours; Tours France

family: Büchler

full_name: Matthias Büchler

given: Matthias

family: Lebranchu

full_name: Yvon Lebranchu

given: Yvon

journal_name: Transplant International

evidence: open (via free article)

lead_sponsor: Novartis Pharmaceuticals

acronym: IDEALE

title: Prospective, Multicenter, Randomized, Open-label, Phase 2, Lasting 12 Weeks, Evaluating the Pharmacodynamics, Efficacy and Safety of Basiliximab in de Novo Adult Renal Transplant Patients at Low Risk Receiving Either a Cumulative Dose of Basiliximab of 40 or 80 mg in Combination With Cyclosporine Microemulsion, or a Cumulative Dose of 80 mg of Basiliximab Without Calcineurin Inhibitor, With Additional Follow-up of 12 Weeks

summary:
The aims of this study are to extensively study the levels of CD25-Receptors saturation and expression obtained with 2 different doses of Simulect® in combination with Neoral® (i.e to demonstrate that saturation and expression vary according to the dose of Simulect® given), and to study the levels of CD25-Receptors saturation without Neoral® and compare them to the data with Neoral®.

It will be conducted in low risk de novo adult renal transplant recipients until 12 weeks post-transplant, receiving either a cumulative dose of 40 or 80 mg of Simulect® in combination with Neoral®, or a cumulative dose of 80 mg of Simulect® in a calcineurin inhibitor free immunosuppressant therapy.


title: Subchondral Microfracture of Tibia After Arthroscopic Anterior Cruciate Ligament Surgery Reconstruction With Two Different Drilling Techniques. Correlation With Postoperative Pain

summary: The arthroscopic anterior cruciate (ACL) ligament reconstruction surgery is widespread. The creation of the tibial tunnel, retrograde or antegrade, is not consensual. A cadaveric study demonstrated tibial subchondral microfractures in the group "antegrade tibial tunnel" unlike group "retrograde tibial tunnel." To our knowledge, no clinical evaluation was performed. The investigators hypothesize that retrograde drilling will cause less local bone injury than antegrade drilling in creation of the tibial tunnel for ACL reconstruction.

lead_sponsor: Hospital Ambroise Paré Paris

location_facility:
Ambroise Paré Hospital
Polyclinique de L'Europe
Hôtel-Dieu CHU Nantes


title: Intravascular Ultrasound (IVUS) Assessment of the Atherosclerotic Plaque Causing an Acute Coronary Syndrome: One-year Changes Under Optimal Secondary Prevention Drug Treatment

acronym: OPTIVUS

summary: Coronary angioplasty is rather frequently performed in such situations, presumably because, changes in the atherosclerotic plaque under drug treatment, have remained poorly described so far. Intravascular ultrasound (IVUS) enables a precise description of coronary atheroma, better than the one provided by coronary angiography.

location_facility:
UH Limoges
UH Bordeaux Haut-Lévêque
UH Toulouse


title: Medico-economic Comparison of Robot-assisted Radical Prostatectomy Using the da Vinci System Versus Radical Prostatectomy Via Laparotomy

acronym: RoboProstate

summary: The main objective of the study is to estimate and compare the overall cost of care of patients over 24 months of follow-up between two groups: (1) patients undergoing robot-assisted radical prostatectomy using the Da Vinci system versus (2) patients undergoing robot-assisted radical prostatectomy via laparotomy.

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Observational and Prospective Multicenter Study to Evaluate the Long-term (10 Years) Performance and Safety (10 Years) of ATF Implants and Lapé Médical Devices Implanted During Total Hip Arthroplasty or Hemiarthroplasty.

summary: Observational and prospective multicenter study to evaluate the long-term (10 years) performance and safety (10 years) of ATF Implants and Lapé Médical devices implanted during total hip arthroplasty or hemiarthroplasty.

lead_sponsor: ATF Implants

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon


title: EValuation of Systemic Atherothrombosis in Patients With ARTerial Disease of the Lower Limbs

acronym: EVART

summary: The purpose of this study is to determine the prevalence and risk factors, at the time of the diagnosis of PAD, for asymptomatic carotid stenosis and abdominal aortic aneurysm.

lead_sponsor: Institut de l'Atherothrombose

location_country: Belgium France

location_facility: Office-based Specialist in vascular medecine


title: Follow-Up of Fully Resected Stage II or III Colorectal Cancer. Phase III Multicentric Prospective Randomised Study

acronym: SURVEILLANCE

summary:
RATIONALE: Diagnostic procedures, such as ultrasound, x-ray, colonoscopy, CT scan, and CEA assessment, may help monitor a patient's response to surgery. It is not yet known which follow-up regimen is more effective in patients who have undergone surgery for colorectal cancer.

PURPOSE: This randomized phase III trial is comparing two types of follow-up care with or without CEA assessments to see how well they work in patients who have undergone surgery for stage II or stage III colorectal cancer.

ReferenceCitation: Lepage C, Phelip JM, Cany L, Faroux R, Manfredi S, Ain JF, Pezet D, Baconnier M, Deguiral P, Terrebone E, Adenis A, Le Malicot K, Bedenne L, Bouché O. Effect of 5 years of imaging and CEA follow-up to detect recurrence of colorectal cancer: The FFCD PRODIGE 13 randomised phase III trial. Dig Liver Dis. 2015 Jul;47(7):529-31. doi: 10.1016/j.dld.2015.03.021. Epub 2015 Apr 2.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_country: Martinique Belgium France

location_facility: Centre Médical National MGEN Alfred Leune

location_facility: Centre d'oncologie et de radiothérapie du Pays Basque

location_facility: Clinique du Cléret et Clinique Saint Joseph

location_facility: Clinique Mutualiste de l'Estuaire - Cité Sanitaire

location_facility: Centre de Radiothérapie et d'oncologie médicale


title: Observational Prospective Multi-center International Study on the Use of Injectable Calcium Phosphate Cements for the Treatment of Bone Defects in Adults.

acronym: CPC

summary: CPC REGISTRY is a multi-center, international, prospective, open-label, observational study on the use of injectable calcium phosphate cements for the treatment of bone defects in adults. All patients will be treated with any of the two injectable calcium phosphate bone substitutes (GRAFTYS®HBS/GRAFTYS®Quickset or their private labels) according to standard clinical practice and according to the information provided by GRAFTYS manufacturer in respective device Instructions For Use (IFU).

lead_sponsor: Graftys SA

location_country: Italy Switzerland France Martinique Germany


title: Study of a Scale Predicting the Feasibility of Chemotherapy in Patients Aged 75 Years or Older With Solid Tumour

acronym: OLD

summary:
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This clinical trial is studying how well combination chemotherapy works in treating older patients with solid tumour.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Centre Hospitalier d'Ardeche Meridionale

location_facility: Centre Hospitalier Intercommunal des Alpes du Sud

location_facility: Centre Medico-Chirurgical et Obstetrique d'Evry

location_facility: Centre Hospitalier Villeneuve Saint Georges

location_facility: Centre Radiotherapie Oncologie Moyenne Garonne


ReferenceCitation: Milési C, Baleine J, Mura T, Benito-Castro F, Ferragu F, Thiriez G, Thévenot P, Combes C, Carbajal R, Cambonie G. Nasal midazolam vs ketamine for neonatal intubation in the delivery room: a randomised trial. Arch Dis Child Fetal Neonatal Ed. 2018 May;103(3):F221-F226. doi: 10.1136/archdischild-2017-312808. Epub 2017 Aug 17.

family: Milési

full_name: Christophe Milési

family: Baleine

full_name: Julien Baleine

given: Julien

family: Mura

full_name: Thibault Mura

given: Thibault

family: Benito-Castro

full_name: Fernando Benito-Castro

given: Fernando

family: Ferragu

full_name: Félicie Ferragu

given: Félicie

family: Thiriez

full_name: Gérard Thiriez

given: Gérard

family: Thévenot

full_name: Pierre Thévenot

family: Combes

full_name: Clémentine Combes

given: Clémentine

family: Carbajal

full_name: Ricardo Carbajal

given: Ricardo

family: Cambonie

full_name: Gilles Cambonie

journal_name: Archives of Disease in Childhood - Fetal and Neonatal Edition

lead_sponsor: University Hospital, Montpellier

location_facility:
Centre Hospitalier Général
Centre Hospitalier Universitaire

title: Intranasal Midazolam Versus Intranasal Ketamine to Sedate Newborns for Intubation in Delivery Room.

summary:
Anesthesia is rarely used to intubate newborns in delivery room because of the very difficulty of accessing veins. The investigators hypothesized that intranasal administration of sedative would be an effective alternative. -Midazolam and Ketamine are two drugs used during neonates' intubation. They are also used intranasally in the absence of venous access-In a pilot study the investigators have demonstrated that sedation with Midazolam was effective in 67% of the patients. Efficiency was defined by a specific pain score: FANS < 4 (Faceless Acute Neonatal Pain Scale) and by an impedancemetric Pain monitor < 0.2 spike/s.

The investigators hypothesized that intranasal ketamine would increase procedure effectiveness from 67 to 90%.

Main objective: To compare newborns sedation quality as they are sedated either by intranasal Midazolam or by intranasal Ketamine during intubation in delivery room.
Secondary Objectives: To compare intubation quality, hemodynamic and respiratory tolerance, and neurological outcomeat 2 years within the two groups.