title: CIQTP Prolongation : Role and Mechanism in Sudden Cardiac Death

acronym: IQARE-SCD

summary:
Despite major progress in molecular and phenotypic characterization of primary electrical disorders, many (aborted) sudden cardiac deaths (SCD) occur in young victims without identifiable abnormalities. Investigator recently identified, in 4 families presenting unexplained SCD, a new arrhythmia entity (catecholamine-induced QT prolongation; CIQTP) characterized by normal QT duration at rest but major QT lengthening during mental stress test (MST).

Investigators aim to determine the prevalence of this new phenotype in unexplained SCD and identify its underlying pathophysiological mechanism.

More specifically, investigators aim to:

determine the prevalence of CIQTP in unexplained SCD and identify new affected families;
identify the role of mental stress in QT prolongation;
identify the genetics basis underlying this life threatening disease;
perform transcriptomic and electrophysiological profiling of induced pluripotent stem cell-derived cardiomyocytes (iPSC-CM) from CIQTP patients to identify putative biomarkers and pathophysiological mechanisms.

MST will be performed, additionally to the conventional screening, in families affected by unexplained SCD or long QT syndrome (LQTS) referred to university hospitals of Nantes, Rennes, Tours and Brest. Relevance of the MST on the different type of LQTS will be evaluated and compared to conventional provocative tests (epinephrine, exercise).

Whole-genome sequencing will first be performed in 3 distantly affected relatives within each of the 4 largest families identified. As previously performed in Nantes, analysis of the shared rare variants will allow identifying gene(s) associated with the disease.

Transcriptomic (high-throughput 3' Digital Gene Expression mRNA sequencing) and electrophysiological (96-well automated optical recordings of action potentials and patch-clamp recordings of ionic currents, using specific ion channel activators and inhibitors) profiling will be performed on iPSC-CMs from 2 affected and one unaffected first-degree relatives of these 4 large families.

location_facility:
Nantes University Hospital
Tours University Hospital
Brest University Hospital
Rennes University Hospital


title: Open Label Phase II Study on Glufosfamide Administered as a 60 Minute Infusion Every 3 Weeks in Advanced Non Small Cell Lung Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Hydration with saline solution may protect kidney cells from the side effects of chemotherapy.

PURPOSE: Randomized phase II trial to study the effectiveness of glufosfamide with or without hydration in treating patients who have advanced non-small cell lung cancer.

status: Completed

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Giaccone G, Smit EF, de Jonge M, Dansin E, Briasoulis E, Ardizzoni A, Douillard JY, Spaeth D, Lacombe D, Baron B, Bachmann P, Fumoleau P; EORTC-New Drug Development Group. Glufosfamide administered by 1-hour infusion as a second-line treatment for advanced non-small cell lung cancer; a phase II trial of the EORTC-New Drug Development Group. Eur J Cancer. 2004 Mar;40(5):667-72.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: French Observatory of Congenital Ventricular Septal Defect With Pulmonary Overload

acronym: FRANCISCO

summary:
Ventricular septal defects (VSD) are the most common cardiac congenital heart defect (about 1/3 of patients with congenital heart disease). VSD management is related to hemodynamics and anatomical localization and the occurrence of complications. Small perimembranous VSD without pulmonary hypertension and without significant left to right shunting are tolerated, whereas large VSD with pulmonary hypertension require early surgical management in the first months of life. The management uncertainties concern the medium-sized perimembranous VSD causing a significant left-right shunt but without pulmonary hypertension, which are of variable treatment (surgical correction, percutaneous treatment, medical or abstention). There are no recommendations or consensus on the preferred indication of a therapeutic attitude.

The Pediatric and Congenital Cardiology Subsidiary, within the French Society of Cardiology, set up an observatory of perimembranous VSD with significant shunting, without pulmonary hypertension the objectives of this study are:

To study the incidence of cardiovascular events in perimembranous VSD and search for predictive anatomical markers of events.
To study the evolution of echocardiographic and functional data of patients having percutaneous or surgical closure compared to patient managed medically.

This observatory will provide a better understanding of the therapeutic algorithm in the management of VSD with pulmonary overload without pulmonary hypertension.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Karonis T, Scognamiglio G, Babu-Narayan SV, Montanaro C, Uebing A, Diller GP, Alonso-Gonzalez R, Swan L, Dimopoulos K, Gatzoulis MA, Li W. Clinical course and potential complications of small ventricular septal defects in adulthood: Late development of left ventricular dysfunction justifies lifelong care. Int J Cardiol. 2016 Apr 1;208:102-6. doi: 10.1016/j.ijcard.2016.01.208. Epub 2016 Jan 23.

ReferenceCitation: Videbæk J, Laursen HB, Olsen M, Høfsten DE, Johnsen SP. Long-Term Nationwide Follow-Up Study of Simple Congenital Heart Disease Diagnosed in Otherwise Healthy Children. Circulation. 2016 Feb 2;133(5):474-83. doi: 10.1161/CIRCULATIONAHA.115.017226. Epub 2015 Dec 18.

ReferenceCitation: Odemis E, Saygi M, Guzeltas A, Tanidir IC, Ergul Y, Ozyilmaz I, Bakir I. Transcatheter closure of perimembranous ventricular septal defects using Nit-Occlud(®) Lê VSD coil: early and mid-term results. Pediatr Cardiol. 2014 Jun;35(5):817-23. doi: 10.1007/s00246-013-0860-8. Epub 2014 Jan 12.

ReferenceCitation: Chungsomprasong P, Durongpisitkul K, Vijarnsorn C, Soongswang J, Lê TP. The results of transcatheter closure of VSD using Amplatzer® device and Nit Occlud® Lê coil. Catheter Cardiovasc Interv. 2011 Dec 1;78(7):1032-40. doi: 10.1002/ccd.23084. Epub 2011 Jun 6.

ipd_sharing: No

lead_sponsor: French Cardiology Society

location_facility:
Hopital Europeen Georges Pompidou
Chu Toulouse - Hopital Des Enfants
Gh Sud Hopital Haut Leveque
Centre Chirurgical Marie Lannelongue

status_simplified: Ongoing


title: Pedopsychiatric and Multidisciplinary Research (Public Health, Psychodynamics, Neuroscience and Human and Social Sciences) Devoted to Children Exposed to the Attack in Nice on July 14, 2016

summary:
On July 14, 2016, in Nice, children and their families were attacked by the organization "EI". In Nice, 86 deaths, including 10 children, the youngest at 4, were recorded. A number of children, still difficult to assess exactly but over 100, was bereaved.

After a traumatic event, multiple clinical consequences may appear in children. Among these consequences, the most common is Post-Traumatic Stress Disorder (PTSD). The aim of the study is to characterize the psycho-social factors of risk and / or protection interfering in the children's future, following the mass trauma of 14 July 2016 in Nice on a sample of pediatric population exposed in comparison of children controls.

Ancillary study, entilted "The Physalis Child", prospectively observe the presence or not of non-psychotic acousto-verbal hallucinations (AVH) in the population with PTSD from the "Program 14-7". The main objective of this ancillary study will be to identify factors of social and emotional cognition linked to the presence of non-psychotic HAV within the cohort of children exposed to the mass trauma of July 14, 2016 in Nice but also to any type of individual trauma

design_allocation: Non-Randomized

primary_purpose: Diagnostic

ReferenceType: derived

ReferenceCitation: Gindt M, Thümmler S, Soubelet A, Guenolé F, Battista M, Askenazy F. Methodology of "14-7" Program: A Longitudinal Follow-Up Study of the Pediatric Population and Their Families Exposed to the Terrorist Attack of Nice on July 14(th), 2016. Front Psychiatry. 2019 Sep 12;10:629. doi: 10.3389/fpsyt.2019.00629. eCollection 2019.

family: Gindt

full_name: Morgane Gindt

given: Morgane

sequence: first

family: Thümmler

full_name: Susanne Thümmler

given: Susanne

sequence: additional

family: Soubelet

full_name: Andréa Soubelet

given: Andréa

family: Guenolé

full_name: Fabian Guenolé

given: Fabian

family: Battista

full_name: Michèle Battista

given: Michèle

family: Askenazy

full_name: Florence Askenazy

given: Florence

bso_classification: Medical research

currency_apc_doaj: USD

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Frontiers in Psychiatry

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 OAI-PMH doi match)

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

title: Methodology of “14–7” Program: A Longitudinal Follow-Up Study of the Pediatric Population and Their Families Exposed to the Terrorist Attack of Nice on July 14th, 2016

lead_sponsor: Fondation Lenval

location_facility: Hôpitaux pédiatriques de Nice CHU-Lenval

intervention_type: Other


type: Other Identifier

title: ILLUMENATE GLOBAL and ISR: Prospective, Single-Arm, Global Multi-Center Study to Evaluate Treatment of Obstructive Superficial Femoral Artery (SFA) and/or Popliteal Lesions With a Novel Paclitaxel-Coated Percutaneous Angioplasty (PTA) Balloon and in In-Stent Restenosis

acronym: ILLUMENATE

summary: Cohort 1: Single-Arm, multicenter study to continue to assess the safety and performance of the Cardiovascular Ingenuity (CVI) Paclitaxel-Coated PTA Balloon Catheter in the treatment of de novo or restenotic lesions in the superficial femoral and/or popliteal arteries Cohort 2: To evaluate this patient population for treatment of in-stent restenotic lesions

status: Active, not recruiting

ReferenceCitation: Gray WA, Jaff MR, Parikh SA, Ansel GM, Brodmann M, Krishnan P, Razavi MK, Vermassen F, Zeller T, White R, Ouriel K, Adelman MA, Lyden SP. Mortality Assessment of Paclitaxel-Coated Balloons: Patient-Level Meta-Analysis of the ILLUMENATE Clinical Program at 3 Years. Circulation. 2019 Oct;140(14):1145-1155. doi: 10.1161/CIRCULATIONAHA.119.040518. Epub 2019 Sep 30.

name: Lankenau Heart Institute/Main Line Health, Philadelphia, PA (W.A.G.).

family: Gray

full_name: William A. Gray

given: William A.

family: Jaff

full_name: Michael R. Jaff

given: Michael R.

name: New York Presbyterian Hospital, Columbia University Irving Medical Center (S.A.P.).

family: Parikh

full_name: Sahil A. Parikh

given: Sahil A.

name: OhioHealth Heart and Vascular Physicians, Columbus (G.M.A.).

family: Ansel

full_name: Gary M. Ansel

given: Gary M.

name: Medical University Graz, Austria (M.B.).

family: Brodmann

full_name: Marianne Brodmann

given: Marianne

family: Krishnan

full_name: Prakash Krishnan

given: Prakash

family: Razavi

full_name: Mahmood K. Razavi

given: Mahmood K.

name: Ghent University Hospital, Belgium (F.V.).

family: Vermassen

full_name: Frank Vermassen

given: Frank

name: Universitäts – Herzzentrum, Freiburg, Germany (T.Z.).

family: Zeller

full_name: Thomas Zeller

given: Thomas

name: Syntactx, New York (R.W., K.O., M.A.A.).

family: White

full_name: Roseann White

given: Roseann

family: Ouriel

full_name: Kenneth Ouriel

given: Kenneth

family: Adelman

full_name: Mark A. Adelman

given: Mark A.

family: Lyden

full_name: Sean P. Lyden

given: Sean P.

journal_name: Circulation

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Ghent University - Ghent University Academic Bibliography

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Spectranetics Corporation

location_country:
Italy
Austria
France
Poland
Australia
Belgium
New Zealand
Spain
Germany
United Kingdom

location_facility: UCL Division of Surgery and Interventional Science

location_facility: CHU de Clermont-Ferrand, Hôpital Gabriel Montpied

location_facility: The Wesley St. Andrew Research Institute Ltd.

location_facility: Monash Medical Centre at Dandenong Campus

location_facility: S.C. Chirurgia Vascolare ed Endovascolare

location_facility: Centre d'Atencio Integral Hospital Dos de Maig

location_facility: Klinikum Immenstadt, Herz-und Gefässzentrum Oberallgäu-Kempten

location_facility: Regionaal Ziekenhuis Heilig Hart Tienen, Campus Mariëndal - MCT, Vascular Surgery Department

location_facility: Medizinische Universität Graz - Univ. Klinik für Innere Medizin

location_facility: Imperial College Academic and Healthcare NHS Trust, St. Mary's Hospital

location_facility: Universitatsklinik, Abteilung Für Diagnostische und Inverventionelle Radiologie

location_facility: Universitats-Herzzentrum Freiburg - Bad Krozingen

intervention_type: Device


title: Acute Necrotizing Pancreatitis and Infected Pancreatic Necrosis: Can we Predict Primary Drainage Failure?

acronym: PANIC

summary: Acute necrotizing pancreatitis is a frequent and potentially lethal disease, especially in case of infected pancreatic necrosis (IPN). IPN usually occurs after the first week of evolution. The step up approach is now widely recommended for the management of IPN. In fact, in case of suspicion of IPN, a drainage percutaneous or transgastric is recommended at first, supported by probabilist antibiotherapy. 1/3 of patients won't require any other interventions. For 2/3 of patients, an additional necrosectomy is necessary. Necrosectomy was formally realized by open laparotomy. Since de last decade, mini-invasive technics have emerged: transgastric necrosectomy, video-assist retroperitoneal debridement. laparoscopy and permitted a decreased of morbidity and mortality. Recently, Hollemans et al. developed a nomogram based on 4 variables (sex, multi-organ failure, % of necrosis and collections heterogeneity) which are negative predictors for success of catheter drainage in IPN with an receiver operating characteristic (ROC) curve at 0.76. The aim of this study is to validate on a large retrospective cohort Hollemans nomogram in predicting catheter drainage success. Secondary aims are to evaluate possible others predictors for success of catheter drainage in IPN and to evaluate the impact of antibiotherapy on microbiological results and on the need for an additional necrosectomy regarding its type and duration, as well as the emergence of multiresistance organism.

study_start_date_type: Anticipated

status: Unknown status

time_perspective: Retrospective

ipd_sharing: Undecided

lead_sponsor: Nantes University Hospital

location_facility:
Angers University Hospital
Nantes University Hospital
Brest University Hospital
Rennes University Hospital

lead_sponsor_type: academique

status_simplified: Unknown


type: EudraCT Number

title: A Phase II Study of Efficacy and Tolerance of Azacitidine (AZA) In MDS-associated Steroid Dependent/Refractory Systemic Auto-immune and Inflammatory Disorders (SAID)

summary: This study is a phase II of effcicacy and tolerance of azacitidine in patients with myelodysplatic syndrome and steroid dependent or resistent systemic auto-immune and inflammatory disorders

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility: Groupe Hospitalier de la Rochelle Ré Aunis

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: CHRU de Montpellier - Service de Médecine Interne

location_facility: Hôpital Saint Antoine - Service d'Hématologie Clinique

location_facility: Hôpital Saint Antoine - Service de Médecine Interne

location_facility: CHU de Montpellier - Service d'hématologie Oncologie


ReferenceCitation: McNamara PJ, Abbassi M. Neonatal exposure to drugs in breast milk. Pharm Res. 2004 Apr;21(4):555-66. Review.

ReferenceCitation: Goldman AS, Hopkinson JM, Rassin DK. Benefits and risks of breastfeeding. Adv Pediatr. 2007;54:275-304. Review.

ReferenceCitation: Marcus SM, Flynn HA, Blow FC, Barry KL. Depressive symptoms among pregnant women screened in obstetrics settings. J Womens Health (Larchmt). 2003 May;12(4):373-80.

ReferenceCitation: Bennett HA, Einarson A, Taddio A, Koren G, Einarson TR. Prevalence of depression during pregnancy: systematic review. Obstet Gynecol. 2004 Apr;103(4):698-709. Review. Erratum in: Obstet Gynecol. 2004 Jun;103(6):1344.

ReferenceCitation: Poobalan AS, Aucott LS, Ross L, Smith WC, Helms PJ, Williams JH. Effects of treating postnatal depression on mother-infant interaction and child development: systematic review. Br J Psychiatry. 2007 Nov;191:378-86. Review.

ReferenceCitation: di Scalea TL, Wisner KL. Pharmacotherapy of postpartum depression. Expert Opin Pharmacother. 2009 Nov;10(16):2593-607. doi: 10.1517/14656560903277202. Review.

ReferenceCitation: Sie SD, Wennink JM, van Driel JJ, te Winkel AG, Boer K, Casteelen G, van Weissenbruch MM. Maternal use of SSRIs, SNRIs and NaSSAs: practical recommendations during pregnancy and lactation. Arch Dis Child Fetal Neonatal Ed. 2012 Nov;97(6):F472-6. doi: 10.1136/archdischild-2011-214239. Review. Erratum in: Arch Dis Child Fetal Neonatal Ed. 2013 Mar;98(2):F180.

ReferenceCitation: Horstmann S, Binder EB. Pharmacogenomics of antidepressant drugs. Pharmacol Ther. 2009 Oct;124(1):57-73. doi: 10.1016/j.pharmthera.2009.06.007. Epub 2009 Jun 27. Review.

ReferenceCitation: Baumann P, Eap CB. Enantiomeric antidepressant drugs should be considered on individual merit. Hum Psychopharmacol. 2001 Dec;16(S2):S85-S92.

ReferenceCitation: Panchaud A, Garcia-Bournissen F, Csajka C, Kristensen JH, Taddio A, Ilett KF, Begg EJ, Ito S. Prediction of infant drug exposure through breastfeeding: population PK modeling and simulation of fluoxetine exposure. Clin Pharmacol Ther. 2011 Jun;89(6):830-6. doi: 10.1038/clpt.2011.23. Epub 2011 Apr 27.

ReferenceCitation: Lobo ED, Quinlan T, O'Brien L, Knadler MP, Heathman M. Population pharmacokinetics of orally administered duloxetine in patients: implications for dosing recommendation. Clin Pharmacokinet. 2009;48(3):189-97. doi: 10.2165/00003088-200948030-00005. Erratum in: Clin Pharmacokinet. 2011 Oct 1;50(10):687-8.

ReferenceCitation: Weisskopf E, Guidi M, Fischer CJ, Bickle Graz M, Beaufils E, Nguyen KA, Morisod Harari M, Rouiller S, Rothenburger S, Gaucherand P, Kassai-Koupai B, Borradori Tolsa C, Epiney M, Tolsa JF, Vial Y, Hascoët JM, Claris O, Eap CB, Panchaud A, Csajka C. A population pharmacokinetic model for escitalopram and its major metabolite in depressive patients during the perinatal period: Prediction of infant drug exposure through breast milk. Br J Clin Pharmacol. 2020 Aug;86(8):1642-1653. doi: 10.1111/bcp.14278. Epub 2020 Apr 14.

name: Center for Research and Innovation in Clinical Pharmaceutical Sciences, Institute of Pharmaceutical Sciences of Western Switzerland, Lausanne University Hospital and University of LausanneUniversity of Geneva Switzerland

family: Weisskopf

full_name: Etienne Weisskopf

given: Etienne

name: Service of Clinical PharmacologyLausanne University Hospital Lausanne Switzerland

family: Guidi

full_name: Monia Guidi

given: Monia

name: Clinic of NeonatologyLausanne University Hospital Lausanne Switzerland

family: Fischer

full_name: Céline J. Fischer

given: Céline J.

family: Bickle Graz

full_name: Myriam Bickle Graz

given: Myriam

name: Department of ObstetricsHospices Civils de Lyon Lyon France

family: Beaufils

full_name: Etienne Beaufils

name: Department of NeonatologyHospices Civils de Lyon Lyon France

name: Department of PharmacotoxicologyCHU Lyon Lyon France

family: Nguyen

full_name: Kim An Nguyen

given: Kim An

name: Division of Child and Adolescent PsychiatryLausanne University Hospital Lausanne Switzerland

family: Morisod Harari

full_name: Mathilde Morisod Harari

given: Mathilde

name: Service of Gynecology and ObstetricsEnsemble hospitalier de la Côte Morges Switzerland

family: Rouiller

full_name: Sylvie Rouiller

given: Sylvie

name: Department of Obstetrics and GynecologyMaternité, CHRU Nancy Nancy France

family: Rothenburger

full_name: Sophie Rothenburger

given: Sophie

family: Gaucherand

full_name: Pascal Gaucherand

given: Pascal

family: Kassai‐Koupai

full_name: Behrouz Kassai‐Koupai

given: Behrouz

name: Division of Child Development and GrowthGeneva University Hospital Geneva Switzerland

family: Borradori Tolsa

full_name: Cristina Borradori Tolsa

given: Cristina

name: Department of Gynecology and ObstetricsGeneva University Hospital Geneva Switzerland

family: Epiney

full_name: Manuella Epiney

given: Manuella

family: Tolsa

full_name: Jean‐François Tolsa

given: Jean‐François

name: Department of Gynecology, Obstetrics and GeneticsLausanne University Hospital Lausanne Switzerland

family: Vial

full_name: Yvan Vial

given: Yvan

name: Department of Neonatology, Maternité RégionaleUniversité de Lorraine Nancy France

family: Hascoët

full_name: Jean‐Michel Hascoët

given: Jean‐Michel

name: Claude Bernard University P2S 4129 Lyon France

family: Claris

full_name: Olivier Claris

given: Olivier

name: Unit of Pharmacogenetics and Clinical Psychopharmacology, Department of PsychiatryLausanne University Hospital Lausanne Switzerland

family: Eap

full_name: Chin B Eap

given: Chin B

name: Pharmacy ServiceLausanne University Hospital Lausanne Switzerland

family: Panchaud

full_name: Alice Panchaud

given: Alice

family: Csajka

full_name: Chantal Csajka

given: Chantal

journal_name: British Journal of Clinical Pharmacology

evidence: open (via free article)

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

location_facility: Service d'Obstétrique, Service de Pédiatrie; Ensemble Hospitalier de la Côte (EHC)

location_facility: Service d'Obstétrique, Service du Développement et de la Croissance; Hopitaux Universitaires Genevois (HUG)

location_facility: Division de Pharmacologie Clinique, Service d'Obstétrique, Service de Néonatologie, Service de Pédopsychiatrie de liaison, Unité de Pharmacogénétique et Psychopharmacologie Clinique; Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Service d'Obstétrique, Service de Néonatologie; Hospices civiles de Lyon (HCL)

location_facility: Service d'Obstétrique, Service de Néonatologie; Centre Hospitalier Universitaire Nancy

title: Antidepressant Treatments During Pregnancy and Lactation: Prediction of Drug Exposure Through Breastfeeding and Evaluation of Drug Effect on the Neonatal Adaptation and the Development of the Young Child

summary:
Background: The childbearing years are a time of increased vulnerability to the onset of mood disorders in women and a high prevalence of exposure to antidepressant drugs during pregnancy and postpartum has been reported. However, the lack of information regarding the milk transfer and the safety of these drugs in breastfed infants and the related fear of adverse events for the sucking infant are some of the factors responsible for stopping prematurely breast-feeding or avoiding drug therapy. Selective serotonin reuptake inhibitors (SSRI) and selective serotonin and noradrenaline reuptake inhibitors (SNRI) are the most frequently prescribed antidepressant drugs during pregnancy and the post-partum period. They exhibit a wide interpatient variability in their concentration profiles that has been related to numerous environmental, stereochemical, demographic and genetic influences that might alter the level of exposure of breastfed newborns. Limited information is available regarding the safety of use of these antidepressant drugs during lactation, and is generally derived from small studies. A comprehensive description of their distribution and quantification in milk in a larger cohort of patients under various influences and the resulting impact on milk concentrations is lacking.

Objectives: The current proposal addresses the primary objectives of quantifying the range of concentration to citalopram, escitalopram, sertraline, fluoxetine, paroxetine, fluvoxamine, duloxetine and venlafaxine in mother plasma and breast milk in relation to genetic polymorphisms, stereochemistry, demographics and environmental factors in a large cohort of depressive mothers. This will enable to derive the exposure to the breast-fed child taking into account this variability and therefore better adjust treatment to potential influences. As secondary objectives, we will examine the neurodevelopmental outcome of a sub-set of infants subjected to SSRI/SNRI in utero and/or during breastfeeding at birth, 6, 18 and 36 months, and compared to that of a control population of infants not subjected to this treatment.

Expected Results: The proposed strategy will offer new information regarding the expected level of drug exposure associated with each or with a combination of risk factors and help for optimizing the security and rationalizing the use of antidepressant treatment in lactating women. Hence, research on the safety of use of these drugs for the developing child is an area of great public health significance.


title: Dolutegravir + Rilpivirine Switch Study (DORISS): Pilot and Noninferiority Trial Comparing Dolutegravir + Rilpivirine vs. Continued HAART (Highly Active Antiretroviral Therapy) in Patients With Plasma HIV RNA ≤ 50 Copies/mL for at Least 2 Years

acronym: DORISS

summary:
The primary objective of the study is to evaluate the capacity of Dolutegravir + Rilpivirine vs. continued triple combination HAART to maintain plasma HIV RNA ≤ 50 copies/ml throughout 24 weeks in patients with plasma HIV RNA ≤ 50 copies/mL for at least 2 years under conventional HAART (2 NNRTI + 3rd agent).

The main secondary objectives are the following:

% of virologic success (plasma viral load ≤ 50 copies/mL) at W24 and W48
% of patients who maintain a plasma viral load ≤ 50 copies / ml from D0 to W48
% of virological failure defined by two consecutive plasma viral load > 50 copies/mL
Profile of genotypic resistance in case of virological failure.

The trial will be conducted according to the design below, in 3 steps:

Step 1: enrollment of 80 patients (40 in each arm)
Step 2: enrollment on hold until W16 data from the 40 patients enrolled in the intervention arm have been analyzed.
Step 3: resumption and completion of enrollment if conditions for resuming enrollment at the end of step 2 are fulfilled, i.e. if the percentage of patients randomized to the intervention arm who have a plasma viral load ≤ 50 copies/mL from D0 to W16 is significantly > 70%, which translates in a maximum of 6 virologic failures.

status: Withdrawn

location_facility:
CHU de Strasbourg
Hôpital Necker - enfants Malades
CHU Kremlin Bicêtre
CHRU de Tours
Hôpital La Pitié Salpêtrière
CHU de Nancy
CHU de Bordeaux
CHU de Fort de France
Hôpital Perpetuel Secours
Hôpital Jean Verdier
CHU BICHAT - Claude Bernard
CHU Guadeloupe
Hôpital FOCH
CH Delafontaine
CHU Toulouse
CHU de Rennes - Hôpital Pontchaillou
Chu Jean Minjoz
CHU de Nantes
CHU Hôtel Dieu Paris
Hôpital Avicenne
Hôpital Saint Louis
CHU Saint Etienne
CHU de DIJON
CHD La Roche sur Yon
Hôpital Européen Georges Pompidou


title: A Phase II, Double-blind, Randomised Study to Assess the Efficacy of AZD6244 in Combination With Dacarbazine Compared With Dacarbazine Alone in First Line Patients With BRAF Mutation Positive Advanced Cutaneous or Unknown Primary Melanoma

summary: To assess the efficacy in terms of overall survival of AZD6244 in combination with dacarbazine, compared with dacarbazine alone, in first line patients with BRAF mutation positive advanced cutaneous or unknown primary melanoma

study_completion_date_type: Actual

ReferenceCitation: Robert C, Dummer R, Gutzmer R, Lorigan P, Kim KB, Nyakas M, Arance A, Liszkay G, Schadendorf D, Cantarini M, Spencer S, Middleton MR. Selumetinib plus dacarbazine versus placebo plus dacarbazine as first-line treatment for BRAF-mutant metastatic melanoma: a phase 2 double-blind randomised study. Lancet Oncol. 2013 Jul;14(8):733-40. doi: 10.1016/S1470-2045(13)70237-7. Epub 2013 Jun 2.

family: Robert

full_name: Caroline Robert

given: Caroline

family: Dummer

full_name: Reinhard Dummer

given: Reinhard

family: Gutzmer

full_name: Ralf Gutzmer

given: Ralf

family: Lorigan

full_name: Paul Lorigan

given: Paul

family: Kim

full_name: Kevin B Kim

given: Kevin B

family: Nyakas

full_name: Marta Nyakas

given: Marta

family: Arance

full_name: Ana Arance

given: Ana

family: Liszkay

full_name: Gabriella Liszkay

given: Gabriella

family: Schadendorf

full_name: Dirk Schadendorf

given: Dirk

family: Cantarini

full_name: Mireille Cantarini

given: Mireille

family: Spencer

full_name: Stuart Spencer

given: Stuart

family: Middleton

full_name: Mark R Middleton

given: Mark R

journal_name: The Lancet Oncology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: AstraZeneca

location_country:
Brazil
Sweden
Switzerland
Netherlands
United Kingdom
Germany
France
Norway
Hungary
Spain
United States
Czech Republic


title: A Phase 1b/2, Open-Label, Multi-Center Study of Tivozanib in Combination With Nivolumab in Subjects With Metastatic Renal Cell Carcinoma

summary:
This study will evaluate the safety, tolerability, dose-limiting toxicities, MTD, and preliminary anti-tumor activity of tivozanib in combination with nivolumab in subjects with metastatic renal cell cancer. This will use a standard '3+3' dose-escalation trial design. A cohort of 3 subjects will be enrolled at each dose level. If 1 of 3 subjects experiences a DLT during Cycle 1, that dose level will be expanded to 6 subjects. If 0 of 3 or ≤ 1 of 6 subjects experience a DLT during Cycle 1, escalation to the next dose will occur. If ≥ 2 of 6 subjects experience a DLT during Cycle 1, dose escalation will stop and the prior dose will be considered the MTD. This is a validated trial design for Phase 1 trials.

Following completion of the dose-escalation cohorts and determination of MTD, an expansion cohort of up to 20 subjects may be enrolled at MTD to further evaluate safety, tolerability, and preliminary anti-tumor activity of tivozanib in combination with nivolumab in the same target population.

ReferenceCitation: Albiges L, Barthélémy P, Gross-Goupil M, Negrier S, Needle MN, Escudier B. TiNivo: safety and efficacy of tivozanib-nivolumab combination therapy in patients with metastatic renal cell carcinoma. Ann Oncol. 2021 Jan;32(1):97-102. doi: 10.1016/j.annonc.2020.09.021. Epub 2020 Sep 30.

family: Albiges

full_name: L. Albiges

given: L.

family: Barthélémy

full_name: P. Barthélémy

given: P.

family: Gross-Goupil

full_name: M. Gross-Goupil

given: M.

family: Negrier

full_name: S. Negrier

given: S.

family: Needle

full_name: M.N. Needle

family: Escudier

full_name: B. Escudier

given: B.

journal_name: Annals of Oncology

oa_host_type: publisher

evidence: open (via crossref license)

lead_sponsor: AVEO Pharmaceuticals, Inc.

location_facility: Bordeaux Hospital University Center (CHU)


title: Multicenter Prospective Evaluation of Radiofrequency for Anal Fistulas

acronym: RADIOFIST

summary:
Anal fistula treatment is associated with increasing risk of anal incontinence until 40% of cases. New and alternative treatments (glue, advancement flap, plug…) decrease this risk, but with fistula efficacy treatment in 40 to 60% of cases. Radiofrequency might destroy fistula tract without lesion of anal sphincter.

Objective : Fistula healing rate and anal continence, 6 and 12 months after radiofrequency procedure.

Methods : Clinical and MRI evaluation before, 6 and 12 months after treatment. Patients : 50 patients with low, high, complex and Crohn disease fistula. An intermediate analysis is expected after the first 20 patients, to verify morbidity.

Evaluations :

Fistula clinical healing 6 and 12 months after procedure
Fistula MRI healing 12 months after procedure
Anal continence before and after procedure
Feasibility og radiofrequency procedure
Morbidity
Success and failure prognostics factors of this procedure

primary_purpose: Other

lead_sponsor: F Care Systems NV

location_facility:
Clinique Blomet
Hopital Bagatelle
CHU Pontchaillou
Chu Nantes

intervention_type: Procedure


title: Predictive Value of a Postural Test on Pulse Pressure Variation During Labor With Epidural Analgesia on Fetal Heart Rate Abnormalities

acronym: PP-PERI

summary: Fetal heart rate abnormalities are common. Miller et al. have demonstrated that new onset fetal heart rate abnormalities after initial labor epidural dosing occur more frequently in women with a low admission pulse pressure than those with a normal admission pulse. The aim of the present study is to look for a statistical link between the occurrence of a fetal heart abnormality requiring an intervention and maternal hemodynamic factors (blood pressure, pulse pressure, and cardiac output) measured before epidural analgesia in two positions: dorsal decubitus position and in the left lateral decubitus.

ReferenceCitation: Miller NR, Cypher RL, Nielsen PE, Foglia LM. Maternal pulse pressure at admission is a risk factor for fetal heart rate changes after initial dosing of a labor epidural: a retrospective cohort study. Am J Obstet Gynecol. 2013 Oct;209(4):382.e1-8. doi: 10.1016/j.ajog.2013.05.049. Epub 2013 Jun 13.

lead_sponsor: Hopital Foch

location_facility:
Hopital Foch
AP-HP Hopital Antoine Beclere
Institut Hospitalier Franco-Britannique
Institut Mutualiste Montsouris


title: Evaluation of the DIABEO System in Poorly Controlled DM1 or DM2 Patients Treated With a Basal-bolus Insulin Regimen

acronym: TELESAGE

summary:
The aim of the TELESAGE study is to demonstrate

the superiority of follow up with the DIABEO system (software alone) versus usual follow up in terms of improvement in HbA1c after 1 year in DM1 or DM2 patients treated with a basal-bolus insulin regimen.
the superiority of follow up with the DIABEO system (software + telemonitoring) compared to usual follow up in terms of improvement in HbA1c after 1 year in DM1 or DM2 patients treated with a basal-bolus insulin regimen.

The DIABEO software alone is an electronic diary system incorporating an immediate automatic aid to calculating the insulin dose according to the prescription given by the doctor, and a data processing, automated analysis message and secure internet data transfer system.

The DIABEO software added by paramedical telemonitoring is the electronic diary combined with remote paramedical monitoring of data (telemeonitoring)

ReferenceCitation: Jeandidier N, Chaillous L, Franc S, Benhamou PY, Schaepelynck P, Hanaire H, Catargi B, Farret A, Fontaine P, Guerci B, Reznik Y, Penfornis A, Borot S, Serusclat P, Kherbachi Y, D'Orsay G, Detournay B, Simon P, Charpentier G. DIABEO App Software and Telemedicine Versus Usual Follow-Up in the Treatment of Diabetic Patients: Protocol for the TELESAGE Randomized Controlled Trial. JMIR Res Protoc. 2018 Apr 19;7(4):e66. doi: 10.2196/resprot.9154.

family: Jeandidier

full_name: Nathalie Jeandidier

given: Nathalie

family: Chaillous

full_name: Lucy Chaillous

given: Lucy

family: Franc

full_name: Sylvia Franc

given: Sylvia

family: Benhamou

full_name: Pierre-Yves Benhamou

given: Pierre-Yves

family: Schaepelynck

full_name: Pauline Schaepelynck

given: Pauline

family: Hanaire

full_name: Hélène Hanaire

given: Hélène

family: Catargi

full_name: Bogdan Catargi

given: Bogdan

family: Farret

full_name: Anne Farret

given: Anne

family: Fontaine

full_name: Pierre Fontaine

given: Pierre

family: Guerci

full_name: Bruno Guerci

given: Bruno

family: Reznik

full_name: Yves Reznik

given: Yves

family: Penfornis

full_name: Alfred Penfornis

given: Alfred

family: Borot

full_name: Sophie Borot

given: Sophie

family: Serusclat

full_name: Pierre Serusclat

family: Kherbachi

full_name: Yacine Kherbachi

given: Yacine

family: D'Orsay

full_name: Geneviève D'Orsay

given: Geneviève

family: Detournay

full_name: Bruno Detournay

family: Simon

full_name: Pierre Simon

family: Charpentier

full_name: Guillaume Charpentier

given: Guillaume

journal_name: JMIR Research Protocols

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

location_facility: Centre hospitalier de Bigorre site La Gespe


title: Safety Evaluation of a Combination of Brain Radiation Therapy and Bevacizumab (Avastin®) for Treatment of Brain Metastasis

summary:
This phase I pilot study aims to define the safety of a combined treatment of bevacizumab and whole brain radiation therapy for the treatment of patients with brain metastasis of solid tumors. If this therapeutic scheme confirms it's safety profile, the investigators can expect:

first, to allow that all patients can receive bevacizumab for their advanced and/or metastatic cancer if necessary, even in case of brain metastasis.
Secondly, if this trial confirm a synergic effect of the combination of angiogenesis inhibitors and brain radiotherapy for local control of brain metastasis, an improvement of the therapeutic results for these patients which have a poor hope of survival and for which none innovative approach is currently suggested.

Moreover, the investigators hope that the analysis of the different data of MRI evaluation - morphological and functional - will allow better definition of radiological evaluation of the therapeutic effect of angiogenesis inhibitors on brain metastasis.

ReferenceCitation: Lévy C, Allouache D, Lacroix J, Dugué AE, Supiot S, Campone M, Mahe M, Kichou S, Leheurteur M, Hanzen C, Dieras V, Kirova Y, Campana F, Le Rhun E, Gras L, Bachelot T, Sunyach MP, Hrab I, Geffrelot J, Gunzer K, Constans JM, Grellard JM, Clarisse B, Paoletti X. REBECA: a phase I study of bevacizumab and whole-brain radiation therapy for the treatment of brain metastasis from solid tumours. Ann Oncol. 2014 Dec;25(12):2351-2356. doi: 10.1093/annonc/mdu465. Epub 2014 Oct 1. Erratum in: Ann Oncol. 2015 Nov;26(11):2359.

family: Lévy

full_name: C. Lévy

given: C.

family: Allouache

full_name: D. Allouache

given: D.

family: Lacroix

full_name: J. Lacroix

given: J.

family: Dugué

full_name: A.E. Dugué

family: Supiot

full_name: S. Supiot

given: S.

family: Campone

full_name: M. Campone

given: M.

family: Mahe

full_name: M. Mahe

family: Kichou

full_name: S. Kichou

family: Leheurteur

full_name: M. Leheurteur

family: Hanzen

full_name: C. Hanzen

family: Dieras

full_name: V. Dieras

given: V.

family: Kirova

full_name: Y. Kirova

given: Y.

family: Campana

full_name: F. Campana

given: F.

family: Le Rhun

full_name: E. Le Rhun

given: E.

family: Gras

full_name: L. Gras

given: L.

family: Bachelot

full_name: T. Bachelot

given: T.

family: Sunyach

full_name: M.-P. Sunyach

family: Hrab

full_name: I. Hrab

given: I.

family: Geffrelot

full_name: J. Geffrelot

family: Gunzer

full_name: K. Gunzer

given: K.

family: Constans

full_name: J.-M. Constans

family: Grellard

full_name: J.-M. Grellard

family: Clarisse

full_name: B. Clarisse

given: B.

family: Paoletti

full_name: X. Paoletti

given: X.

location_facility:
Centre Léon Bérard
Centre François Baclesse
Centre Oscar Lambret
Institut Curie
Centre René Gauducheau
Centre Henri Becquerel


title: SHIVA02 - Evaluation of the Efficacy of Targeted Therapy Based on Tumor Molecular Profiling in Patients With Advanced Cancer Using Each Patient as Its Own Control

summary: The study will evaluate the efficacy of targeted therapy based on tumor molecular profiling versus conventional chemotherapy in patients with advanced cancer using each patient as its own control. This study is a study involving patients with advanced cancer. All types of solid tumors will be allowed in the study.

primary_purpose: Screening

ReferenceCitation: Dupain C, Masliah-Planchon J, Gu C, Girard E, Gestraud P, Du Rusquec P, Borcoman E, Bello D, Ricci F, Hescot S, Sablin MP, Tresca P, de Moura A, Loirat D, Frelaut M, Vincent-Salomon A, Lecerf C, Callens C, Antonio S, Franck C, Mariani O, Bièche I, Kamal M, Le Tourneau C, Servois V. Fine-needle aspiration as an alternative to core needle biopsy for tumour molecular profiling in precision oncology: prospective comparative study of next-generation sequencing in cancer patients included in the SHIVA02 trial. Mol Oncol. 2021 Jan;15(1):104-115. doi: 10.1002/1878-0261.12776. Epub 2020 Sep 15.

name: Department of Drug Development and Innovation (D3i) Institut Curie Paris & Saint‐Cloud France

family: Dupain

full_name: Célia Dupain

given: Célia

name: Department of Genetics Institut Curie PSL Research University Paris France

family: Masliah‐Planchon

full_name: Julien Masliah‐Planchon

given: Julien

name: Department of Pathology Institut Curie PSL Research University Paris France

family: Gu

full_name: Céline Gu

given: Céline

name: INSERM U900 Research Unit Institut Curie Saint‐Cloud France

family: Girard

full_name: Elodie Girard

given: Elodie

family: Gestraud

full_name: Pierre Gestraud

given: Pierre

family: Du Rusquec

full_name: Pauline Du Rusquec

given: Pauline

family: Borcoman

full_name: Edith Borcoman

given: Edith

family: Bello

full_name: Diana Bello

given: Diana

family: Ricci

full_name: Francesco Ricci

given: Francesco

family: Hescot

full_name: Ségolène Hescot

given: Ségolène

family: Sablin

full_name: Marie‐Paule Sablin

given: Marie‐Paule

family: Tresca

full_name: Patricia Tresca

given: Patricia

family: Moura

full_name: Alexandre Moura

given: Alexandre

family: Loirat

full_name: Delphine Loirat

given: Delphine

family: Frelaut

full_name: Maxime Frelaut

given: Maxime

family: Vincent‐Salomon

full_name: Anne Vincent‐Salomon

given: Anne

family: Lecerf

full_name: Charlotte Lecerf

given: Charlotte

family: Callens

full_name: Céline Callens

family: Antonio

full_name: Samantha Antonio

given: Samantha

family: Franck

full_name: Coralie Franck

given: Coralie

family: Mariani

full_name: Odette Mariani

given: Odette

name: INSERM U1016 Faculty of Pharmaceutical and Biological Sciences Paris Descartes University Paris France

family: Bièche

full_name: Ivan Bièche

given: Ivan

family: Kamal

full_name: Maud Kamal

given: Maud

family: Le Tourneau

name: Department of Radiology Institut Curie PSL Research University Paris & Saint‐Cloud France

title: Fine‐needle aspiration as an alternative to core needle biopsy for tumour molecular profiling in precision oncology: prospective comparative study of next‐generation sequencing in cancer patients included in the SHIVA02 trial

location_facility:
Institut Bergonié
Institut Curie
Institut Curie Hôpital René Huguenin
Centre LEON BERARD


title: Interest of Auriculotherapy in Prophylaxis of Migraine and Headache in Patients With Migraines

acronym: Migauric

summary: The aim of the study is to show that auriculotherapy decreases the number of days with painful episodes of migraine and headache after 3 months of treatment

location_facility:
Hopital Foch
GHP Saint Joseph
Centre Médical de L'Olivier
Cabinet Médical


title: Auditory Nerve Monitoring Using Intra-cochlear Stimulation in Subjects With Acoustic Neuroma : Feasibility Study

acronym: NeuriStim

summary: The aim of this study is to assess the auditory nerve functionality with an intraoperative approach following a surgical removal of acoustic neuroma in patients with severe to profound sensorineural hearing disabilities.

lead_sponsor: Oticon Medical

location_facility: University Hospital Lyon - Edouard Herriot

location_facility: University Hospital Bordeaux - Pellegrin

location_facility: University Hospital Grenoble - A. Michallon


title: Modalities of Respiratory Care, Vital and Respiratory Prognosis in Neuromuscular Patients Admitted to an Intensive Care Unit for Respiratory Failure

summary:
Retrospective multicentric observational study exploring the population of adult neuromuscular patients presenting a respiratory distress requiring their admission in an Intensive Care Unit (ICU) for ventilatory support.

Research of markers associated with long term mortality and ventilatory status.

lead_sponsor: Hospices Civils de Lyon

location_facility:
CHU Clermont Ferrand
Hôpital de la Croix Rousse
CHU Grenoble
Hôpital Nord CHU St Etienne


title: A Phase III, Open-label, Randomized Study of Osimertinib With or Without Platinum Plus Pemetrexed Chemo, as First-line Treatment in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation Positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLAURA2).

summary:
The reason for the study is to find out if an experimental combination of an oral medication called osimertinib (TAGRISSO®) when used in combination with chemotherapy is more effective than giving osimertinib alone for the treatment of locally advanced or metastatic non-small cell lung cancer. Some lung cancers are due to mutations in the Deoxyribonucleic acid (DNA) which, if known, can help physicians decide the best treatment for their patients. One type of mutation can occur in the gene that produces a protein on the surface of cells called the Epidermal Growth Factor Receptor (EGFR).

Osimertinib is an Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor (TKI) that targets Epidermal Growth Factor Receptor (EGFR) mutations. Unfortunately, despite the benefit observed for patients treated with osimertinib, the vast majority of cancers are expected to develop resistance to the drug over time. The exact reasons why resistance develops are not fully understood but based upon clinical research it is hoped that combining osimertinib with another type of anti-cancer therapy known as chemotherapy will delay the onset of resistance and the worsening of a patient's cancer.

In total the study aims to enroll approximately 586 patients, consisting of approximately 30 patients who will participate in a safety run-in component of the trial, and approximately 556 who will receive osimertinib alone or osimertinib in combination with chemotherapy in the main trial. In the main part of the trial there is a one in two chance of receiving osimertinib alone, and the treatment is decided at random by a computer.

The study involves a Screening Period, Treatment Period, and Follow up Period. Whilst receiving study medication, it is expected patients will attend, on average, approximately 15 visits over the first 12 months and then approximately 4 visits per year afterwards. Each visit will last about 2 to 6 hours depending on the arrangement of medical assessments by the study centre.

ReferenceCitation: Planchard D, Feng PH, Karaseva N, Kim SW, Kim TM, Lee CK, Poltoratskiy A, Yanagitani N, Marshall R, Huang X, Howarth P, Jänne PA, Kobayashi K. Osimertinib plus platinum-pemetrexed in newly diagnosed epidermal growth factor receptor mutation-positive advanced/metastatic non-small-cell lung cancer: safety run-in results from the FLAURA2 study. ESMO Open. 2021 Oct;6(5):100271. doi: 10.1016/j.esmoop.2021.100271. Epub 2021 Sep 17.

family: Planchard

full_name: D. Planchard

given: D.

family: Feng

full_name: P.-H. Feng

family: Karaseva

full_name: N. Karaseva

given: N.

family: Kim

full_name: S.-W. Kim

full_name: T.M. Kim

family: Lee

full_name: C.K. Lee

family: Poltoratskiy

full_name: A. Poltoratskiy

given: A.

family: Yanagitani

full_name: N. Yanagitani

family: Marshall

full_name: R. Marshall

given: R.

family: Huang

full_name: X. Huang

given: X.

family: Howarth

full_name: P. Howarth

given: P.

family: Jänne

full_name: P.A. Jänne

family: Kobayashi

full_name: K. Kobayashi

given: K.

currency_apc_doaj: EUR

journal_name: ESMO Open

title: Osimertinib plus platinum–pemetrexed in newly diagnosed epidermal growth factor receptor mutation-positive advanced/metastatic non-small-cell lung cancer: safety run-in results from the FLAURA2 study

ReferenceCitation: White MN, Piotrowska Z, Stirling K, Liu SV, Banwait MK, Cunanan K, Sequist LV, Wakelee HA, Hausrath D, Neal JW. Combining Osimertinib With Chemotherapy in EGFR-Mutant NSCLC at Progression. Clin Lung Cancer. 2021 May;22(3):201-209. doi: 10.1016/j.cllc.2021.01.010. Epub 2021 Jan 27.

family: White

full_name: Maya N White

given: Maya N

family: Piotrowska

full_name: Zofia Piotrowska

given: Zofia

family: Stirling

full_name: Kevin Stirling

given: Kevin

family: Liu

full_name: Stephen V Liu

given: Stephen V

family: Banwait

full_name: Mandeep K Banwait

given: Mandeep K

family: Cunanan

full_name: Kristen Cunanan

ReferenceCitation: Asahina H, Tanaka K, Morita S, Maemondo M, Seike M, Okamoto I, Oizumi S, Kagamu H, Takahashi K, Kikuchi T, Isobe T, Sugio K, Kobayashi K. A Phase II Study of Osimertinib Combined With Platinum Plus Pemetrexed in Patients With EGFR-Mutated Advanced Non-Small-cell Lung Cancer: The OPAL Study (NEJ032C/LOGIK1801). Clin Lung Cancer. 2021 Mar;22(2):147-151. doi: 10.1016/j.cllc.2020.09.023. Epub 2020 Oct 16.

title: A Phase II Study of Osimertinib Combined With Platinum Plus Pemetrexed in Patients With EGFR-Mutated Advanced Non–Small-cell Lung Cancer: The OPAL Study (NEJ032C/LOGIK1801)

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

location_country:
Peru
Australia
Russian Federation
Taiwan
India
France
Japan
Thailand
Slovakia
Argentina
Canada
Korea, Republic of
South Africa
Chile
Vietnam
Philippines
China
United States
United Kingdom
Brazil
Czechia


title: Fetal Heart Rate Variability Analysis for the Early Detection of Chorioamnionitis During Preterm Premature Rupture of Membranes

acronym: AiRPM

summary: All included patients will have their fetal heart rate recording performed with an EDAN F3 fetal monitor that allowed the back up recording of the fetal heart rate beat to beat detection. Fetal heart rate variability analysis will be performed using Matalb® software.

lead_sponsor: Rennes University Hospital

location_facility:
CHU Rennes Hôpital Sud
Service de Gynecologie obstétrique
Service de Gynecologie Obstétrique
Service de gynecologique-obstétrique


title: GENetic & Immunologic Abnomalies in Systemic Lupus Erythematosus

acronym: GENIAL

summary:
Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease for which the aetiology includes genet-ic and environmental factors. It is rare in children as compared to adults. The severity may be related to greater involvement of genetic factors in children. The impact of genetics in the development of SLE is important, and the risk of recurrence in siblings evaluated by lambda S ratio is 30 in SLE, while it is 15 for type-1 diabetes and 8 rheumatoid arthritis, thereby indicating high impact of genetics in SLE.

Recently, the group of Professor Yanick Crow in Manchester and other teams has identified new forms of lupus Mendelian genetics. The TREX1 and genes involved in the SAMHD1 frostbite lupus.

Nearly 2 % of all adult subjects with SLE have a heterozygous mutation in the TREX1 gene, which therefore represents the first genetic cause of SLE. The team of Professor Crow also identified the ACP5 gene that is responsible for SLE associated with Spondylo-epiphyseal enchondro-epiphyseal dysplasia (syndromic lupus). Other groups have identified mutations in two genes encoding a DNAse (DNAse1 and DNAse1L3) responsible for familial monogenic forms of SLE. These new genes SLE were identified through research of germ-line mutations in cases of lupus syndromic or family. In collaboration with Professor Crow, we are currently undergoing characterization of a novel gene of SLE in a family and we have identified a second locus identified in another family. The identification of these genes provides a better understanding of the mechanisms regulating immune tolerance in humans. The frequency of these genetic forms is not known. There is very little data on the immunological phenotype of these patients.

This is a clinical study to investigate the genetic and immunological abnormalities associated with pediatric SLE. The aim are to:

study the genetics of pediatric SLE (or syndromic or family) and to search for mutations in the known genetic lupus or new genes in collaboration with Professor Yanick Crow.
study the lymphocyte subpopulations and serum cytokines in pediatric patients with SLE (or syndromic or family) in the large Rhône- Alpes- Auvergne area.

ReferenceCitation: Weill O, Decramer S, Malcus C, Kassai B, Rouvet I, Ginhoux T, Crow YJ, Rieux-Laucat F, Soulas-Sprauel P, Pagnier A, Koné-Paut I, Piram M, Galeotti C, Samaille C, Reumaux H, Lanteri A, Dubois SM, Lefebvre H, Burtey S, Maurier F, Carbasse A, Lemelle I, Meinzer U, Despert V, Flodrops H, Fabien N, Ranchin B, Hachulla E, Bader-Meunier B, Belot A. Familial and syndromic lupus share the same phenotype as other early-onset forms of lupus. Joint Bone Spine. 2017 Oct;84(5):589-593. doi: 10.1016/j.jbspin.2016.12.008. Epub 2016 Dec 28.

family: Weill

full_name: Olivia Weill

given: Olivia

family: Decramer

full_name: Stéphane Decramer

given: Stéphane

family: Malcus

full_name: Christophe Malcus

given: Christophe

family: Kassai

full_name: Behrouz Kassai

given: Behrouz

family: Rouvet

full_name: Isabelle Rouvet

given: Isabelle

family: Ginhoux

full_name: Tiphanie Ginhoux

given: Tiphanie

family: Crow

full_name: Yanick J. Crow

given: Yanick J.

family: Rieux-Laucat

full_name: Fredéric Rieux-Laucat

given: Fredéric

family: Soulas-Sprauel

full_name: Pauline Soulas-Sprauel

given: Pauline

family: Pagnier

full_name: Anne Pagnier

given: Anne

family: Koné-Paut

full_name: Isabelle Koné-Paut

family: Piram

full_name: Maryam Piram

given: Maryam

family: Galeotti

full_name: Caroline Galeotti

given: Caroline

family: Samaille

full_name: Charlotte Samaille

given: Charlotte

family: Reumaux

full_name: Héloïse Reumaux

given: Héloïse

family: Lanteri

full_name: Aurélia Lanteri

given: Aurélia

family: Dubois

full_name: Sandrine Morell Dubois

given: Sandrine Morell

family: Lefebvre

full_name: Hélène Lefebvre

given: Hélène

family: Burtey

full_name: Stéphane Burtey

family: Maurier

full_name: François Maurier

given: François

family: Carbasse

full_name: Aurélia Carbasse

family: Lemelle

full_name: Irène Lemelle

given: Irène

family: Meinzer

full_name: Ulrich Meinzer

given: Ulrich

location_facility: Service de Néphrologie et Rhumatologie Pédiatrique

location_facility: Service de médecine interne - Hôpitaux privés de Metz

location_facility: Service de pédiatrie - CHU Fort de France

location_facility: Service d'hématologie / oncologie pédiatrique - CHU

location_facility: Service de néphrologie - médecine interne - Hypertension pédiatrique - Hôpital des enfants

location_facility: Service de néphrologie, endocrinologie, maladie métabolique et hématologie bénigne pédiatriques - Hôpital Jeanne de Flandre

location_facility: édiatrie générale, urgences et maladies infectieuses, Hôpital Salengro

location_facility: Service de pédiatrie générale - Hôpital Robert-Debré

location_facility: Service de Rhumatologie Pédiatrique - Hôpital de Bicêtre

location_facility: Service de néphrologie pédiatrique - CHU de Nantes

location_facility: Service pédiatrie grands enfants-adolescents - CHU Hôpital Sud

location_facility: Service de Néphrologie - Hôpital Edouard Herriot

location_facility: Service de médecine infantile- Hôpital Nord

location_facility: Médecine Interne Adulte - Centre Hospitalier Lyon Sud

location_facility: Service de médecine interne - Centre de référence des maladies rares

location_facility: Service d'immunologie et rhumatologie pédiatrique - Centre de référence de maladies rhumatologiques et inflammatoires rares en pédiatrie-Hôpital Necker-Enfants malades

location_facility: Service de médecine interne - Hôpital Saint Antoine

location_facility: Service de Rhumatologie - Centre Hospitalier Lyon Sud

location_facility: ervice d'urgence et post-urgences pédiatriques - CHU Arnaud de Villeneuve

location_facility: Service de Pédiatrie Générale - CHU Réunion

location_facility: Centre de néphrologie et de transplantation rénale - Hôpital de la conception


title: Immuno Nutrition by L-citrulline for Critically Ill Patients

acronym: Immunocitre

summary: The main objective of this study is to demonstrate that the only administration of L-citrulline, can improve immune functions in critically ill patients at high risk of nosocomial infection.

primary_purpose: Prevention

location_facility:
CHU Angers
Paris - HEGP
Rennes Hospital University
CHU Nantes


title: Predictive Value of Biomarkers of the Alzheimer's Disease (AD) in Elderly Patients With New-onset Epilepsy

acronym: BIOMALEPSIE

summary:
Beyond 60 years, the prevalence of epilepsy is estimated at approximately 1% and increases with age. In these patients, the etiology of epilepsy is unknown in 25% of cases, even up to 55% after 65 years. Although new-onset epilepsy in the elderly is associated with a vascular disease in 50% of cases, the hypothesis of an ongoing neurodegenerative process, including an Alzheimer's disease (AD), is also common. However, investigators do not have any marker that might help to identify the patients who develop epilepsy after 60 years and who might be, despite a normal cognitive functioning, already engaged in the pathophysiological process of AD.

A number of data suggest a link between the pathophysiological process of AD and epileptogenesis:

(i) a third of patients with epilepsy develops MA, (ii) the occurrence of epilepsy in AD is an aggravating factor for cognition, (iii) in animal models of AD, the relationship between neuronal hyperexcitability and amyloid deposits is bidirectional, the amyloid protein has a pro-seizure effect and the presence of epilepsy increases the amyloid deposits, (iv) in these models, the administration of an antiepileptic drug protects from deterioration of cognition, (v) the close relationship between amyloid and neuronal hyperexcitability might be mediated by the inflammatory processes associated with AD, and particularly the microglial activation which role in epileptogenesis has been shown elsewhere.

Investigators hypothesize that in a subgroup of patients who develop epilepsy after 60 years, the occurrence of epilepsy might reflect the presence of an ongoing amyloid pathology. Our goal is to identify through biomarkers of AD in the cerebrospinal fluid of patients who develop an epilepsy after 60 years with normal MRI and normal cognition those at high risk of later developing clinically defined AD.

Identifying patients with amyloid pathology which would be expressed through epilepsy before the onset of cognitive dysfunction might help to adapt both the management of seizures and of the cognitive dysfunction.

location_facility:
Hospices Civils de Lyon
CHU Hôpital Nord
CHU des Alpes
CHU Gabriel- Montpied

intervention_type: Biological


title: Role of Prophylaxis by Oral Fluid Supplementation in Prevention of Postdural Puncture Headache: A Non-inferiority Randomized Controlled Trial

acronym: PROPHYDRA

summary:
Postdural puncture headache (PDPH) is defined, according to the International Headache Society, as any headache develops within 5 days after a lumbar puncture. It worsens within 15 minutes after sitting or standing and improves within 15 minutes after lying.

For preventing PDPH, there are some uncomfortable practices for patients (fluid supplementation and bed rest) and expensive for hospital (time spend for information and management of fluid intake). Patients are usually advised by nurses. If "bed rest" is not effective in prevention of PDPH, "fluid supplementation" is not an advice based on any evidence but only on routine. By this trial, the investigators want to evaluate the scientific value of this advice, in the standard patient care.

The primary objective of this study is to compare oral hyperhydration (2 liters during 2 hours after lumbar puncture - the most common routine according to an internal pilot survey) versus no advice about the fluid intake to prevent the PDPH.

The second objective is to observe the day of apparition of PDPH, between day 0 and day 5.

ReferenceCitation: Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658.

ReferenceCitation: Arevalo-Rodriguez I, Ciapponi A, Roqué i Figuls M, Muñoz L, Bonfill Cosp X. Posture and fluids for preventing post-dural puncture headache. Cochrane Database Syst Rev. 2016 Mar 7;3:CD009199. doi: 10.1002/14651858.CD009199.pub3. Review.

ReferenceCitation: Armon C, Evans RW; Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Addendum to assessment: Prevention of post-lumbar puncture headaches: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2005 Aug 23;65(4):510-2.

ReferenceCitation: Dieterich M, Brandt T. Incidence of post-lumbar puncture headache is independent of daily fluid intake. Eur Arch Psychiatry Neurol Sci. 1988;237(4):194-6.

location_facility:
Hospital centre CORNOUAILLE
University Hospital NANTES
Hospital centre CHD VENDEE
Hospital centre LE MANS


title: Study of Predictive Immunological Parameters of Molecular Complete Remission in Patients With Chronic Myelogenous Leukemia in Chronic Phase and Treated With Tyrosine Kinase Inhibitor

summary:
The investigators recently identified promiscuous HLA-DR-derived epitopes from the human telomerase reverse transcriptase (TERT) called universal cancer peptides (UCP), to study tumor-specific CD4+ T cell responses.

The aim of this prospective preliminary study is to evaluate the presence of UCP-specific Th1 responses in patients in complete remission of CML two years after end of Tyrosine Kinase Inhibitor (TKi) treatments.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Régional Universitaire de Besançon


title: Targeting Leukemic Stem Cell Expressing the IL-1RAP Protein in Chronic Myelogenous Leukemia (CML)

acronym: CAR-LMC

summary:
The tyrosine kinase inhibitor therapy (iTKs) is the first-line treatment of chronic myelogenous leukemia (CML).

Its effectiveness in controlling the progression of the disease is such that it is possible today to consider stopping treatment in patients with deep molecular response (> RM4.0).

Only in about 50% of cases, patients relapse. It has been shown in these patients that hematopoietic stem cells (HSCs) are persistant, quiescent and insensitive to iTKs. These cells are probably at the origin of relapse. It is therefore necessary to develop complementary therapies to cure the disease and consider discontinuation iTKs The development of anti-tumor immunotherapy approach using genetically modified T cells to express a chimeric antigen receptor (CAR) and specifically targeting CML CSH + could address this issue. The membrane expression of the IL-1-RAP protein could be an interesting target.


title: Evaluation of the Diagnostic Value of Level of Bone Marrow Tryptase in Adult Systemic Mastocytosis

acronym: EvaTryMS

summary:
The hypothesis of the study is that Bone Marrow Tryptase (MT) level is a diagnostic marker of Systemic Mastocytosis (SM). Determination of the bone marrow tryptase in Bone Marrow Aspirate (BMA) could be a new diagnostic criteria for systemic mastocytosis with sensitivity close to 100% and a low false negative rate. This new test could be useful to improve the ability to diagnose accurately systemic mastocytosis (in particular the indolent forms). Because of its limited invasiveness compared to bone marrow biopsy, it could also be considered as a test performed before bone marrow biopsy. Only patients with high bone marrow tryptase would then undergo bone marrow biopsy.

In the future and if validated by this study, bone marrow tryptase could be a useful marker of mast cell load and help to monitor the efficacy of treatment in systemic mastocytosis.

ReferenceCitation: Valent P, Horny HP, Escribano L, Longley BJ, Li CY, Schwartz LB, Marone G, Nuñez R, Akin C, Sotlar K, Sperr WR, Wolff K, Brunning RD, Parwaresch RM, Austen KF, Lennert K, Metcalfe DD, Vardiman JW, Bennett JM. Diagnostic criteria and classification of mastocytosis: a consensus proposal. Leuk Res. 2001 Jul;25(7):603-25. Review.

ReferenceCitation: Valent P, Akin C, Escribano L, Födinger M, Hartmann K, Brockow K, Castells M, Sperr WR, Kluin-Nelemans HC, Hamdy NA, Lortholary O, Robyn J, van Doormaal J, Sotlar K, Hauswirth AW, Arock M, Hermine O, Hellmann A, Triggiani M, Niedoszytko M, Schwartz LB, Orfao A, Horny HP, Metcalfe DD. Standards and standardization in mastocytosis: consensus statements on diagnostics, treatment recommendations and response criteria. Eur J Clin Invest. 2007 Jun;37(6):435-53. Review.

ReferenceCitation: Akin C, Valent P, Metcalfe DD. Mast cell activation syndrome: Proposed diagnostic criteria. J Allergy Clin Immunol. 2010 Dec;126(6):1099-104.e4. doi: 10.1016/j.jaci.2010.08.035. Epub 2010 Oct 28.

ReferenceCitation: Alvarez-Twose I, González de Olano D, Sánchez-Muñoz L, Matito A, Esteban-López MI, Vega A, Mateo MB, Alonso Díaz de Durana MD, de la Hoz B, Del Pozo Gil MD, Caballero T, Rosado A, Sánchez Matas I, Teodósio C, Jara-Acevedo M, Mollejo M, García-Montero A, Orfao A, Escribano L. Clinical, biological, and molecular characteristics of clonal mast cell disorders presenting with systemic mast cell activation symptoms. J Allergy Clin Immunol. 2010 Jun;125(6):1269-1278.e2. doi: 10.1016/j.jaci.2010.02.019.

ReferenceCitation: Barete S, Assous N, de Gennes C, Grandpeix C, Feger F, Palmerini F, Dubreuil P, Arock M, Roux C, Launay JM, Fraitag S, Canioni D, Billemont B, Suarez F, Lanternier F, Lortholary O, Hermine O, Francès C. Systemic mastocytosis and bone involvement in a cohort of 75 patients. Ann Rheum Dis. 2010 Oct;69(10):1838-41. doi: 10.1136/ard.2009.124511. Epub 2010 Jun 22.

ReferenceCitation: Paul C, Sans B, Suarez F, Casassus P, Barete S, Lanternier F, Grandpeix-Guyodo C, Dubreuil P, Palmérini F, Mansfield CD, Gineste P, Moussy A, Hermine O, Lortholary O. Masitinib for the treatment of systemic and cutaneous mastocytosis with handicap: a phase 2a study. Am J Hematol. 2010 Dec;85(12):921-5. doi: 10.1002/ajh.21894.

lead_sponsor: University Hospital, Toulouse

location_country: Martinique France

location_facility: CHU Lyon Sud, service de médecine interne

location_facility: CHU Toulouse, Hôpital Larrey, service de dermatologie

location_facility: CHU Bordeaux Hôpital Haut-Lévêque, service de dermatologie

location_facility: CHU Fort de France, service de dermatologie


title: Agreement Between Oral and Cervical Human Papillomavirus Infection in a French Cohort of Women Infected With Cervical HPV

acronym: PAPILLOR

summary:
Human papillomaviruses (HPVs) are the most common of sexually transmitted viral agents and they are associated with genital and oral diseases.

Agreement between cervical and oral HPV infection has been described from a small group of patient. Our study, performed on a greater number of patients, will provide a good estimation of this link, between cervical and oral infection, in a French population of women with a primary cervical HPV infection.

primary_purpose: Health Services Research

lead_sponsor: Institut de Cancérologie de Lorraine

location_facility: Maternité Régionale Universitaire de Nancy


type: Other Grant/Funding Number

title: Inter-regional Cohort of Neonatal and Infant Cholestasis in the Greater Southwest Region

acronym: CHOLESTASE

summary: The goal of the study is to characterize the epidemiologic data of the neonatal and infant cholestasis.

status: Terminated

location_facility:
UH Limoges
UH Bordeaux
UH Toulouse
UH Montpellier


title: Filling Bone Erosions: a Longitudinal Multicentric HR-pQCT Study of 12 Months Subcutaneous Tocilizumab in Rheumatoid Arthritis Phase IV Prospective Multicentrique Study

acronym: REPAIR

summary:
Rheumatoid arthritis (RA) is a chronic inflammatory disease mediated by the production of several cytokines, which leads to the destruction of bone and cartilage tissue in multiple joints and to bone loss. Conventional radiographs (CR) are considered as the gold standard for diagnosis and follow up of joint changes in RA. But this method has low sensitivity to detect early erosive changes and is unable to evaluate periarticular bone loss.

High Resolution peripheral QCT (HRpQCT) enables the detection of erosions less than 0.5 mm in width or depth at metacarpo-phalangeal (MCP) joints. Using 3-D high resolution analysis of cortical bone erosions, this one is also able to evaluate the volumes of erosion and the evolution under treatments IL6 (6- interleukin) plays a major role in inflammatory process and bone damages related to RA. Tocilizumab (TCZ) is a humanized anti-IL-6R monoclonal antibody, developed and investigated in several clinical trials in RA. This biotherapy, in association with methotrexate (MTX) or given in monotherapy, is efficient in RA with inadequate response to MTX or anti-TNF b (tumor necrosis factor). TCZ reduces dramatically systemic inflammation, structural progression and improves clinical symptoms and quality of life.

Tocilizumab may help reducing bone erosions, periarticular osteopenia and systemic bone loss.

ReferenceCitation: Boutroy S, Bouxsein ML, Munoz F, Delmas PD. In vivo assessment of trabecular bone microarchitecture by high-resolution peripheral quantitative computed tomography. J Clin Endocrinol Metab. 2005 Dec;90(12):6508-15. Epub 2005 Sep 27.

ReferenceCitation: Stach CM, Bäuerle M, Englbrecht M, Kronke G, Engelke K, Manger B, Schett G. Periarticular bone structure in rheumatoid arthritis patients and healthy individuals assessed by high-resolution computed tomography. Arthritis Rheum. 2010 Feb;62(2):330-9. doi: 10.1002/art.27252.

ReferenceCitation: Fouque-Aubert A, Boutroy S, Marotte H, Vilayphiou N, Bacchetta J, Miossec P, Delmas PD, Chapurlat RD. Assessment of hand bone loss in rheumatoid arthritis by high-resolution peripheral quantitative CT. Ann Rheum Dis. 2010 Sep;69(9):1671-6. doi: 10.1136/ard.2009.114512. Epub 2010 Jun 4.

ReferenceCitation: Ellouz R, Chapurlat R, van Rietbergen B, Christen P, Pialat JB, Boutroy S. Challenges in longitudinal measurements with HR-pQCT: evaluation of a 3D registration method to improve bone microarchitecture and strength measurement reproducibility. Bone. 2014 Jun;63:147-57. doi: 10.1016/j.bone.2014.03.001. Epub 2014 Mar 12.

ReferenceCitation: Møller Døhn U, Boonen A, Hetland ML, Hansen MS, Knudsen LS, Hansen A, Madsen OR, Hasselquist M, Møller JM, Østergaard M. Erosive progression is minimal, but erosion healing rare, in patients with rheumatoid arthritis treated with adalimumab. A 1 year investigator-initiated follow-up study using high-resolution computed tomography as the primary outcome measure. Ann Rheum Dis. 2009 Oct;68(10):1585-90. doi: 10.1136/ard.2008.097048. Epub 2008 Nov 19.

ReferenceCitation: Finzel S, Rech J, Schmidt S, Engelke K, Englbrecht M, Stach C, Schett G. Repair of bone erosions in rheumatoid arthritis treated with tumour necrosis factor inhibitors is based on bone apposition at the base of the erosion. Ann Rheum Dis. 2011 Sep;70(9):1587-93. doi: 10.1136/ard.2010.148395. Epub 2011 May 27.

ReferenceCitation: Døhn UM, Ostergaard M, Bird P, Boonen A, Johansen JS, Møller JM, Hansen MS. Tendency towards erosive regression on magnetic resonance imaging at 12 months in rheumatoid arthritis patients treated with rituximab. Ann Rheum Dis. 2009 Jun;68(6):1072-3. doi: 10.1136/ard.2008.098962.

ReferenceCitation: Døhn UM, Ejbjerg B, Boonen A, Hetland ML, Hansen MS, Knudsen LS, Hansen A, Madsen OR, Hasselquist M, Møller JM, Ostergaard M. No overall progression and occasional repair of erosions despite persistent inflammation in adalimumab-treated rheumatoid arthritis patients: results from a longitudinal comparative MRI, ultrasonography, CT and radiography study. Ann Rheum Dis. 2011 Feb;70(2):252-8. doi: 10.1136/ard.2009.123729. Epub 2010 Oct 26.

ReferenceCitation: Finzel S, Rech J, Schmidt S, Engelke K, Englbrecht M, Schett G. Interleukin-6 receptor blockade induces limited repair of bone erosions in rheumatoid arthritis: a micro CT study. Ann Rheum Dis. 2013 Mar;72(3):396-400. doi: 10.1136/annrheumdis-2011-201075. Epub 2012 May 14.

ReferenceCitation: Garnero P, Thompson E, Woodworth T, Smolen JS. Rapid and sustained improvement in bone and cartilage turnover markers with the anti-interleukin-6 receptor inhibitor tocilizumab plus methotrexate in rheumatoid arthritis patients with an inadequate response to methotrexate: results from a substudy of the multicenter double-blind, placebo-controlled trial of tocilizumab in inadequate responders to methotrexate alone. Arthritis Rheum. 2010 Jan;62(1):33-43. doi: 10.1002/art.25053.

family: Garnero

full_name: Patrick Garnero

given: Patrick

family: Thompson

full_name: Elizabeth Thompson

given: Elizabeth

family: Woodworth

full_name: Thasia Woodworth

given: Thasia

family: Smolen

full_name: Josef S. Smolen

given: Josef S.

journal_name: Arthritis & Rheumatism

evidence: open (via free pdf)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Rapid and sustained improvement in bone and cartilage turnover markers with the antiâinterleukin-6 receptor inhibitor tocilizumab plus methotrexate in rheumatoid arthritis patients with an inadequate response to methotrexate: Results from a substudy of the multicenter double-blind, placebo-controlled trial of tocilizumab in inadequate responders to methotrexate alone

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility:
Hopital Nord CHU de SAint ETIENNE
Chu Toulouse
Hopital Edouard HERIOT
CHR d'ORLEANS


title: Measuring Auto-fluorescence of White Corpuscles for the Early Diagnosis and the Monitoring of Pneumonia in Intensive Care Units

acronym: BIONAGA

summary: The diagnosis of pneumonia is challenging in Intensive Care Unit. The auto-fluorescence of white corpuscles is altered during pneumonia. In presence of bacterial growth on lung samples, the measure of autofluorescence of white corpuscles could help the clinicians to discriminate bacterial colonization from acute infection.

ReferenceCitation: Monsel A, Lécart S, Roquilly A, Broquet A, Jacqueline C, Mirault T, Troude T, Fontaine-Aupart MP, Asehnoune K. Analysis of autofluorescence in polymorphonuclear neutrophils: a new tool for early infection diagnosis. PLoS One. 2014 Mar 21;9(3):e92564. doi: 10.1371/journal.pone.0092564. eCollection 2014.

location_facility:
Vannes Hospital
Saint-NazaireHospital
Saint-Brieuc Hospital
Blois Hospital


title: DNA Repair Enzyme Signature Associated With Response to Chemo- and Radio-therapy in Head and Neck Cancer: ChemRadAssay

acronym: CHEMRAD

summary:
Squamous cell carcinoma (HNSCC) is the most frequent form of head and neck cancer. The therapeutic choice depends on the stage of the disease and the habits of the medical teams. Surgery, radiotherapy and chemotherapy can be used, alone or combined. However, none of the existing strategies has proven its superiority.

Chemotherapy and radiotherapy induce DNA damages in the tumor cells. However, cells have the ability to induce DNA reparation, capable of causing treatment resistance. DNA reparation in non-tumor tissues can also explain the toxicity of cancer treatments.

Investigation of DNA repair pathways involved in chemo- or radiation resistance could offer a good strategy for identifying biomarkers or indicators of treatment response. This study will explore the capacity of a comprehensive functional approach that addresses several pathways, based on the use of three innovative patented technologies, to classify the tumor response of HNSCC patients to treatments according to their DNA Repair Enzyme Signature.

Our hypothesis is that taking into account various clinical parameters (e.g. patient and tumor characteristics), treatment strategy and measuring the DNA Repair Enzyme Signature would create patients' profiles and optimize their management.

location_facility: Hospices Civils de Lyon - Hôpital de la Croix Rousse


title: SALTO -2 ( Long Term Monitoring In Oncology ) : Getting Long-term Management of Adult Children Cured of Childhood Cancer in Rhône-Alpes, Multicentric Study

summary:
Children cancers are rare and survival rate are around 75%. 1 French adult out of 850 is estimated as a children-cancer-survivor. Chemotherapy, radiotherapy or surgical complications can lead to a late risk of death. A regularly support, a therapeutic education, a support of the psychological difficulties have a positive impact on the quality of life and on long-term health for patients surviving to a cancer.

The ARCERRA exists, registering around 150 new cases a year. They coordinated, from 2011 to 2014, a multicentric study with a long term follow up in oncology (SALTO). 150 patients diagnosed between 1987 and 1992 were included, and the study demonstrated the feasibility and utility for patients and their physicians of a long-term follow-up coupled with an interview with a psychologist in Rhône-Alpes-Auvergne.

The primary objective of SALTO-2 project is to know the becoming of young adults that survived to pediatric cancer, diagnosed in Rhône-Alpes between 1993 and 1999. The second objective is in one hand to study the psychological becoming and on another hand, to ameliorate their lifestyle thanks to different documents created specially for them.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
Chu Grenoble
IHOP1 de Lyon
CH Lyon Sud - Pierre Bénite
Chu Saint Etienne


title: SALTO-BIO (Long Term Follow up in Oncology) - PanCareLIFE. Long Term Support for Pediatric Cancer Survivors in Rhône-Alpes. Evaluation of Women Fertility.

acronym: SALTO-BIO

summary:
PanCareLIFE Study is a cohort study of patients treated for cancer in childhood, and biological case-control study nested in the cohort (WP4) is coordinated by Erasmus MC-Sophia Children's Hospital in Holland.

Ensure optimal patient quality of life throughout his life is a priority for the research teams. PanCareLIFE Study also aims to identify the factors that predispose to impaired quality of life. It is in this light that will be offered to patients a quality of life questionnaires during the period of treatment and then periodically during long-term follow-up.

location_facility:
IHOP 1 Lyon
Chu Grenoble
CHU Saint-Etienne
CH Lyon Sud


title: Study of the Involvement of IL-17 / IL-22 Pathway in Bacterial Exacerbations of COPD

summary: Chronic obstructive pulmonary disease (COPD) is a worldwide chronic inflammatory disease of the airways linked to environmental exposure. The chronic course of COPD is often interrupted by acute exacerbations which have a major impact on the morbidity and mortality of COPD patients. A bacterial etiology for these exacerbations is common (almost 50%). Moreover, airway bacterial colonization linked to an increased susceptibility is observed in COPD patients. Effective Th17 immune response is needed to develop a good response against bacteria. Thus, this study aims to demonstrate that there is a defective IL-17/ IL-22 response to bacteria in COPD leading to airway bacterial colonization and infection.

primary_purpose: Basic Science

lead_sponsor: University Hospital, Lille

location_facility:
Tourcoing hospital
University hospital of Lille
Roubaix hospital
Seclin hospital


title: Uterine Allotransplantations Using Uterine Grafts From Brain-dead Female Donors

acronym: ATU

summary:
Uterus transplantation may enable women with uterine factor infertility to become pregnant and give birth.

This study will explore the feasibility of a uterine transplant and eight subjects will undergo deceased donor uterine transplantation at CHU de Limoges.

There phases involved in this study: Primary, Secondary and Tertiary Screening, Medical Evaluation, IVF, Transplantation, Embryo Transfer, Pregnancy/Delivery and Follow up.

status: Suspended

lead_sponsor: University Hospital, Limoges

location_facility:
Service de Pharmacologie
Service de gynécologie
Service de néphrologie
Service de réanimation


title: Circulating Tumor DNA and Follow-up of BRCA1 Mutation Carriers (CirCa 01)

summary: BRCA1 carriers who are at high risk of developing either a relapse and/or a new cancer growth will be included. These patients will be followed up during 30 months (2,5 years) with mutated TP53 mutation detection or during 42 months (3,5 years) with mutated TP53 mutation detection and circulating tumor cells detection (CTC) performed at each hospital visit (for technical reason only patients included at Institut Curie will be proposed to participate to the CTC substudy).

lead_sponsor: Institut Curie

location_facility:
Hôpital René Huguenin - Institut Curie
Institut Gustave ROUSSY
Centre Léon Bérard
Institut Curie


title: AVAD: Asthma With Small Airways Dysfunction. Clinical, Immunobiological, Tomodensitometric Description, Genetic Signature Compared With Asthmatic Population With Proximal Airways Obstruction

acronym: AVAD

summary:
The aim of the study is to describe asthma phenotype with small airways dysfunction, in a multiparametric manner, with clinical, biological, morphological and genetic elements compared with asthma with proximal airways obstruction.

The objective of this study is also to complete the clinical, immunobiological and morphological analysis of asthma with small airways dysfunction.

location_facility: CABINETS DE PNEUMOLOGIE LIBERALE HIA Desgenettes

intervention_type: Genetic


title: End Of Life in the Critically Ill patiEnt

acronym: EOLE

summary: The purpose of this multicentric study is to evaluate the perception of the quality of the end of life in intensive care units seen from the side of the caregivers, trough the CAESAR scale.

ReferenceCitation: SRLF Trial Group. End of life in the critically ill patient: evaluation of experience of end of life by caregivers (EOLE study). Ann Intensive Care. 2021 Nov 26;11(1):162. doi: 10.1186/s13613-021-00944-z.

family: Aissaoui

full_name: Nadia Aissaoui

given: Nadia

family: Amilien

full_name: Virginie Amilien

given: Virginie

family: Antier

full_name: Nadiejda Antier

given: Nadiejda

family: Auvet

full_name: Adrien Auvet

given: Adrien

family: Azoulay

full_name: Elie Azoulay

given: Elie

family: Barbar

full_name: Saber Davide Barbar

given: Saber Davide

family: Bavozet

full_name: Florent Bavozet

given: Florent

family: Berger

full_name: Asael Berger

given: Asael

family: Blidi

full_name: Sami Blidi

given: Sami

family: Boissier

full_name: Florence Boissier

given: Florence

family: Bouju

full_name: Pierre Bouju

given: Pierre

family: Brunin

full_name: Yannick Brunin

given: Yannick

family: Canoville

full_name: Bertrand Canoville

given: Bertrand

family: Chalies

full_name: Maguelone Chalies

given: Maguelone

family: Chemouni

full_name: Frank Chemouni

given: Frank

family: Couret

full_name: David Couret

given: David

family: Danguy

full_name: Marc Danguy

given: Marc

family: Daubin

full_name: Cédric Daubin

given: Cédric

family: Decormeille

full_name: Guillaume Decormeille

given: Guillaume

family: Demoule

full_name: Alexandre Demoule

given: Alexandre

family: Duvivier

full_name: Julien Duvivier

given: Julien

family: Ehrmann

full_name: Stephan Ehrmann

given: Stephan

family: Escudier

full_name: Etienne Escudier

given: Etienne

location_facility: Centre Hospitalier Communal des Alpes du Sud

location_facility: Centre Hospitalier Lucie et Raymond Aubrac


title: Study of Characteristics of Medically Unexplained Chronic Pain in Children and Adolescents.

acronym: PEDOUL

summary:
Medically unexplained chronic pain - without identifiable somatic origin - is yet an insufficiently known and explored field in children and adolescents by international clinical works. This research aims to characterize somatic, psychological, psychopathological and environmental (particularly attachment styles and family functioning) processes trough an observational study with three pain management centers.

The study concerns children and adolescents from 7 to 17 years old, suffering of medically unexplained chronic pain and their parents who are referred to a pain center. It is composed of a somatic, psychological and family functioning assessment on the one hand and psychopathological and attachment evaluation on the other hand.

location_facility:
Hopital NECKER
CHU de SAINT-ETIENNE
Hospices Civils de LYON
Hopital TROUSSEAU


title: Bergonie Institut Profiling : Fighting Cancer by Matching Molecular Alterations and Drugs in Early Phase Trials

acronym: BIP

summary:
This is a biology driven, monocentric study designed to identify actionable molecular alterations in cancer patients with advanced disease.

In this trial, high throughput analysis will be carried out using next generation sequencing, and immunological profiling.

Patients included in the BIP study and for whom a targetable genomic alteration had been identified might be subsequently included in an early phase trials running at Institut Bergonie or another French hospital.

lead_sponsor: Institut Bergonié

location_facility:
Centre Hospitalier de Pau
Centre Hospitalier de la Côte Basque
Clinique Marzet
Institut Bergonie


title: Influence of the Modality of General Anesthesia Guided by the Bispectral Index (Manual or Automated) on the Occurrence of a Loss of Capability in Elderly Patients (> 70 Yrs): a Randomized Multicenter Study

acronym: FRAGIL

summary: The first aim of this study is to compare two methods of administration of intravenous anesthetics to obtain the same level of depth (bispectral index between 40 and 60): manual or automated and to determine a mid-term (6 months) influence of the frail phenotype on self-sufficient elderly patients after general anesthesia.

ReferenceCitation: Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56.

ReferenceCitation: Liu N, Chazot T, Hamada S, Landais A, Boichut N, Dussaussoy C, Trillat B, Beydon L, Samain E, Sessler DI, Fischler M. Closed-loop coadministration of propofol and remifentanil guided by bispectral index: a randomized multicenter study. Anesth Analg. 2011 Mar;112(3):546-57. doi: 10.1213/ANE.0b013e318205680b. Epub 2011 Jan 13.

family: Liu

full_name: Ngai Liu

given: Ngai

family: Chazot

full_name: Thierry Chazot

given: Thierry

family: Hamada

full_name: Sophie Hamada

given: Sophie

family: Landais

full_name: Alain Landais

given: Alain

family: Boichut

full_name: Nathalie Boichut

given: Nathalie

family: Dussaussoy

full_name: Corinne Dussaussoy

given: Corinne

family: Trillat

full_name: Bernard Trillat

given: Bernard

family: Beydon

full_name: Laurent Beydon

given: Laurent

family: Samain

full_name: Emmanuel Samain

given: Emmanuel

family: Sessler

full_name: Daniel I. Sessler

given: Daniel I.

family: Fischler

full_name: Marc Fischler

journal_name: Anesthesia & Analgesia

title: Closed-Loop Coadministration of Propofol and Remifentanil Guided by Bispectral Index

ReferenceCitation: Le Guen M, Herr M, Bizard A, Bichon C, Boichut N, Chazot T, Liu N, Ankri J, Fischler M. Frailty Related to Anesthesia guided by the Index "bispectraL" (FRAIL) study: study protocol for a randomized controlled trial. Trials. 2017 Mar 16;18(1):127. doi: 10.1186/s13063-017-1868-9.

family: Le Guen

full_name: Morgan Le Guen

given: Morgan

family: Herr

full_name: Marie Herr

given: Marie

family: Bizard

full_name: Antoine Bizard

given: Antoine

family: Bichon

full_name: Caroline Bichon

given: Caroline

family: Ankri

full_name: Joel Ankri

given: Joel

title: Frailty Related to Anesthesia guided by the Index “bispectraL” (FRAIL) study: study protocol for a randomized controlled trial

location_facility:
Hopital Jean Minjoz
Centre Clinical
Hopital Foch
Institut Hopsitalier Franco-Britannique


title: Descriptive Analysis of Non Steroidal Antiinflammatory Drugs Use in Patients Diagnosed With Community Acquired Pneumonia

acronym: ALPAJ

summary: To investigate exposure to nonsteroidal antiinflammatory drugs (NSAIDs) during outpatient management at the early stage of community-acquired pneumonia (CAP) requiring hospital consultation. Non-interventional observational study.

ReferenceCitation: Voiriot G, Dury S, Parrot A, Mayaud C, Fartoukh M. Nonsteroidal antiinflammatory drugs may affect the presentation and course of community-acquired pneumonia. Chest. 2011 Feb;139(2):387-394. doi: 10.1378/chest.09-3102. Epub 2010 Aug 19.

ReferenceCitation: Messika J, Sztrymf B, Bertrand F, Billard-Pomares T, Barnaud G, Branger C, Dreyfuss D, Ricard JD. Risks of nonsteroidal antiinflammatory drugs in undiagnosed intensive care unit pneumococcal pneumonia: younger and more severely affected patients. J Crit Care. 2014 Oct;29(5):733-8. doi: 10.1016/j.jcrc.2014.05.021. Epub 2014 Jun 4. Review.

lead_sponsor: Hôpital Louis Mourier

location_facility:
Louis Mourier Hospital
Tenon Hospital
Centre Hospitalier Victor Dupouy
Hôpital Max Fourestier


title: High Flow Nasal Oxygen for Bronchoscopy With Bronchoalveolar Lavage in Acute Respiratory Failure Patients: the OptiBAL Study.

acronym: Optibal

summary: Bronchoscopy with bronchoalveolar lavage (BAL) is at risk for worsening hypoxemia in patients with acute respiratory failure (ARF). High-flow nasal cannula oxygen (HFNC) improves hypoxemia in ARF patients . We investigated its efficacy and tolerance in intensive care unit patients admitted for ARF requiring BAL.

ReferenceCitation: Messika J, Ben Ahmed K, Gaudry S, Miguel-Montanes R, Rafat C, Sztrymf B, Dreyfuss D, Ricard JD. Use of High-Flow Nasal Cannula Oxygen Therapy in Subjects With ARDS: A 1-Year Observational Study. Respir Care. 2015 Feb;60(2):162-9. doi: 10.4187/respcare.03423. Epub 2014 Nov 4.

ReferenceCitation: Ricard JD. High flow nasal oxygen in acute respiratory failure. Minerva Anestesiol. 2012 Jul;78(7):836-41. Epub 2012 Apr 24. Review.

ReferenceCitation: Sztrymf B, Messika J, Bertrand F, Hurel D, Leon R, Dreyfuss D, Ricard JD. Beneficial effects of humidified high flow nasal oxygen in critical care patients: a prospective pilot study. Intensive Care Med. 2011 Nov;37(11):1780-6. doi: 10.1007/s00134-011-2354-6. Epub 2011 Sep 27.

ReferenceCitation: Simon M, Braune S, Frings D, Wiontzek AK, Klose H, Kluge S. High-flow nasal cannula oxygen versus non-invasive ventilation in patients with acute hypoxaemic respiratory failure undergoing flexible bronchoscopy--a prospective randomised trial. Crit Care. 2014 Dec 22;18(6):712. doi: 10.1186/s13054-014-0712-9.

family: Simon

full_name: Marcel Simon

given: Marcel

family: Braune

full_name: Stephan Braune

given: Stephan

family: Frings

full_name: Daniel Frings

given: Daniel

family: Wiontzek

full_name: Ann-Kathrin Wiontzek

given: Ann-Kathrin

family: Klose

full_name: Hans Klose

given: Hans

family: Kluge

full_name: Stefan Kluge

given: Stefan

currency_apc_doaj: GBP

journal_name: Critical Care

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

title: High-flow nasal cannula oxygen versus non-invasive ventilation in patients with acute hypoxaemic respiratory failure undergoing flexible bronchoscopy - a prospective randomised trial

ReferenceCitation: Lucangelo U, Vassallo FG, Marras E, Ferluga M, Beziza E, Comuzzi L, Berlot G, Zin WA. High-flow nasal interface improves oxygenation in patients undergoing bronchoscopy. Crit Care Res Pract. 2012;2012:506382. doi: 10.1155/2012/506382. Epub 2012 May 20.

name: Department of Perioperative Medicine, Intensive Care and Emergency, Cattinara Hospital, Trieste University School of Medicine, Strada di Fiume 447, 34149 Trieste, Italy

family: Lucangelo

full_name: Umberto Lucangelo

given: Umberto

name: Department of Pneumology, Cattinara Hospital, 34149 Trieste, Italy

family: Vassallo

full_name: Fabio Giuseppe Vassallo

given: Fabio Giuseppe

family: Marras

full_name: Emanuele Marras

given: Emanuele

family: Ferluga

full_name: Massimo Ferluga

given: Massimo

family: Beziza

full_name: Elena Beziza

given: Elena

family: Comuzzi

full_name: Lucia Comuzzi

given: Lucia

family: Berlot

full_name: Giorgio Berlot

given: Giorgio

name: Carlos Chagas Filho Institute of Biophysics, Federal University of Rio de Janeiro, 21949-900 RJ Rio de Janeiro, Brazil

family: Zin

full_name: Walter Araujo Zin

given: Walter Araujo

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

repository_institution: University of Trieste https://www.units.it/ - ArTS Archivio della ricerca di Trieste

title: High-Flow Nasal Interface Improves Oxygenation in Patients Undergoing Bronchoscopy

ReferenceCitation: Maitre B, Jaber S, Maggiore SM, Bergot E, Richard JC, Bakthiari H, Housset B, Boussignac G, Brochard L. Continuous positive airway pressure during fiberoptic bronchoscopy in hypoxemic patients. A randomized double-blind study using a new device. Am J Respir Crit Care Med. 2000 Sep;162(3 Pt 1):1063-7.

ReferenceCitation: La Combe B, Messika J, Labbé V, Razazi K, Maitre B, Sztrymf B, Dreyfuss D, Fartoukh M, Ricard JD. High-flow nasal oxygen for bronchoalveolar lavage in acute respiratory failure patients. Eur Respir J. 2016 Apr;47(4):1283-6. doi: 10.1183/13993003.01883-2015. Epub 2016 Feb 11.

location_facility:
Hopital Antoine Béclère
Hopital Henri Mondor
Louis Mourier Hospital
Hôpital Tenon


title: Assessment of the Efficacy on the Reduction of Nocturnal Hypoglycemia in Children With Type 1 Diabetes of a Closed-loop Insulin Therapy (Artificial Pancreas) Compared to Insulin Pump Therapy Combined With Continuous Glucose Monitoring With Threshold Low Glucose Suspend of Infusion in Home-like Conditions

acronym: SHAN

summary: The objective of this study is to assess the efficacy of an Artificial Pancreas system which includes a Control-To-Range algorithm, versus standard Insulin Pump Therapy with Threshold Low glucose Suspend feature. 24 Children aged from 7 to 12 will be recruted in 4 clinical centres. After a 2 week run-in period, they will attend two investigational sessions of 65 hours in home-like settings. During each session, the CTR algorithm or the TLGS feature will be activated, depending on the randomization. The main endpoint is the time spent below 70mg/dL between 22:00 and 07:00.

ReferenceCitation: Renard E, Tubiana-Rufi N, Bonnemaison-Gilbert E, Coutant R, Dalla-Vale F, Farret A, Poidvin A, Bouhours-Nouet N, Abettan C, Storey-London C, Donzeau A, Place J, Breton MD. Closed-loop driven by control-to-range algorithm outperforms threshold-low-glucose-suspend insulin delivery on glucose control albeit not on nocturnal hypoglycaemia in prepubertal patients with type 1 diabetes in a supervised hotel setting. Diabetes Obes Metab. 2019 Jan;21(1):183-187. doi: 10.1111/dom.13482. Epub 2018 Aug 21.

name: Department of Endocrinology, Diabetes, Nutrition; Montpellier University Hospital; Montpellier France

name: INSERM Clinical Investigation Centre 1411; Montpellier France

name: Institute of Functional Genomics; University of Montpellier; Montpellier France

family: Renard

full_name: Eric Renard

given: Eric

name: Department of Pediatric Endocrinology and Diabetology; Robert Debré University Hospital, Assistance Publique-Hôpitaux de Paris, University of Paris Diderot Sorbonne Paris Cité; Paris France

family: Tubiana-Rufi

full_name: Nadia Tubiana-Rufi

given: Nadia

name: Department of Pediatrics; Tours University Hospital; Tours France

family: Bonnemaison-Gilbert

full_name: Elisabeth Bonnemaison-Gilbert

given: Elisabeth

name: Department of Endocrinology and Diabetology, Pediatrics Federation; Angers University Hospital; Angers France

family: Coutant

full_name: Régis Coutant

given: Régis

name: Department of Pediatrics; Montpellier University Hospital, University of Montpellier; Montpellier France

family: Dalla-Vale

full_name: Fabienne Dalla-Vale

given: Fabienne

family: Farret

full_name: Anne Farret

given: Anne

family: Poidvin

full_name: Amélie Poidvin

given: Amélie

family: Bouhours-Nouet

full_name: Natacha Bouhours-Nouet

given: Natacha

family: Abettan

full_name: Charlotte Abettan

given: Charlotte

family: Storey-London

full_name: Caroline Storey-London

family: Donzeau

full_name: Aurelie Donzeau

given: Aurelie

family: Place

full_name: Jerome Place

given: Jerome

name: Center for Diabetes Technology, University of Virginia; Charlottesville Virginia

family: Breton

full_name: Marc D. Breton

given: Marc D.

journal_name: Diabetes, Obesity and Metabolism

lead_sponsor: University Hospital, Montpellier

location_facility:
CHU Montpellier - Hôpital Lapeyronie
CHU d'Angers
AP-HP, Hôpital Robert Debré
CHU de Tours, Hôpital Clocheville