title: Assessment of Quality of Global and Sexual Life and Impact of Surgical and Non Surgical Vaginal Aplasia in Patients With a Rokitansky Syndrome

acronym: MRKH

summary:
The principal objective is to assess the general health status and the sexual health status of women with Rokitansky syndrome having received a surgical or non surgical treatment.

The secondary purpose is to assess the anatomical aspect and the quality of sexual life. To search a correlation between the anatomical result, the general and sexual quality of life. To compare the different techniques of medical follow-up in terms of anatomic results, general quality of life, sexual quality of life, complications and morbidities.

To evaluate social inclusion of these women with their family situation, social and professional category and their job.

At the same time, we propose an evaluation with a psychologist to study the impact of the announcement of the diagnosis. This impact study is conducted at a distance from diagnosis.

ReferenceCitation: Cheikhelard A, Bidet M, Baptiste A, Viaud M, Fagot C, Khen-Dunlop N, Louis-Sylvestre C, Sarnacki S, Touraine P, Elie C, Aigrain Y, Polak M; French MRKH Study Group. Surgery is not superior to dilation for the management of vaginal agenesis in Mayer-Rokitansky-Küster-Hauser syndrome: a multicenter comparative observational study in 131 patients. Am J Obstet Gynecol. 2018 Sep;219(3):281.e1-281.e9. doi: 10.1016/j.ajog.2018.07.015. Epub 2018 Jul 21.

location_facility: Service d'Endocrinologie et Gynécologie Pédiatriques Hôpital Necker Enfants Malades


title: Multicenter Observational Study on Myocardial Iron Overload in 3 Multitransfused Populations

acronym: SUFEMYO

summary: The investigators' primary objective is to study prevalences of myocardial iron overload, defined as a cardiac T2*< 20 ms, in 3 populations of multiply transfused patients, affected with thalassemia, sickle cell disease, and myelodysplasia.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Biological

lead_sponsor_type: academique

status_simplified: Completed


type: Other Identifier

title: TRESTIS: Multicentric Study With a Curative Endoscopic Treatment of Superficial Neoplasia of a Digestive Tract by Endoscopic Submucosal Dissection: Evaluation of a New Water Jet System Injecting Glycerol Mix

summary: safety evaluation of endoscopic sub-mucosal dissection with nestis enki2 system. This system is a new water jet system which allows to perform Endoscopic submucosal dissection with a bifunctional catheter (injection and cutting).

study_type: Interventional

primary_purpose: Treatment

lead_sponsor: Hôpital Edouard Herriot

intervention_type: Procedure


type: Other Grant/Funding Number

title: Learning Mechanisms of Food Preferences in 2-3 y. o. Toddlers in Nurseries

summary: The aim of this study is to understand the formation of food preferences from an early age.

lead_sponsor: Centre des Sciences du Goût et de l'Alimentation

lead_sponsor_type: industriel


summary: To evaluate response rate of cisplatin - metronomic cyclophosphamide treatment.

status: Terminated

lead_sponsor: Centre Jean Perrin

intervention_type: Drug

status_simplified: Unknown


summary: Study assessing efficacy of a Cisplatine- Métronomic cyclophosphamide treatment in Patients with Metastatic Triple Negative breast Cancer Secondary Resistant to Anthracyclines and Taxanes.


title: Sodium-Lactate Versus Mannitol in the Treatment of Intracranial Hypertensive Episodes in Severe Traumatic Brain Injured Patients

summary: The purpose of this study is to compare the effect of bolus of either sodium-lactate or mannitol on the evolution of intracranial pressure (ICP) during intracranial hypertensive episodes (IHE)

design_allocation: Randomized

lead_sponsor: Institut d'Anesthesiologie des Alpes Maritimes


title: Primary Organoid Models and Combined Nucleic Acids Therapeutics for Innovative Anti-HPV Treatments in Cervico-vaginal Cancers and Precancerous Lesions

acronym: ORGANOIDES

summary:
Human papilloma virus (HPV) is responsible of the most common sexually transmitted infection. It can cause severe cancer lesions, of the cervix, vulva, vagina, penis and oropharynx. The International Agency for Cancer Research of World Health Organization (WHO) classified a dozen of HPV related high-risk cancer types, and recognized cervical cancer as the most common HPV-related disease. HPV 16 and 18 are responsible for 70% of cervical cancers.

Due to the few symptoms of cervical cancer, women are often diagnosed with advanced state. Current treatments imply cervical conisation or hysterectomy, with or without lymphadenectomy and or radiotherapy, or chemotherapy.

However, few pharmacological options are available against oncogenic papilloma viruses and thus against recurrences The aim of this project is to develop relevant organoids models from patient biopsies that will be used to identify biomarkers and evaluate in a closest preclinical setting novel nucleic acids based therapeutic strategy for HPV-cervical-vaginal dysplasia and cancers.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

primary_purpose: Basic Science

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Ngamkham J, Boonmark K, Phansri T. Detection and Type-Distribution of Human Papillomavirus in Vulva and Vaginal Abnormal Cytology Lesions and Cancer Tissues from Thai Women. Asian Pac J Cancer Prev. 2016;17(3):1129-34.

ReferenceCitation: Duke P, Godwin M, Ratnam S, Dawson L, Fontaine D, Lear A, Traverso-Yepez M, Graham W, Ravalia M, Mugford G, Pike A, Fortier J, Peach M. Effect of vaginal self-sampling on cervical cancer screening rates: a community-based study in Newfoundland. BMC Womens Health. 2015 Jun 10;15:47. doi: 10.1186/s12905-015-0206-1.

ReferenceCitation: Koo YJ, Min KJ, Hong JH, Lee JK. Efficacy of Poly-Gamma-Glutamic Acid in Women with High-Risk Human Papillomavirus-Positive Vaginal Intraepithelial Neoplasia: an Observational Pilot Study. J Microbiol Biotechnol. 2015 Jul;25(7):1163-9. doi: 10.4014/jmb.1503.03106.

ReferenceCitation: Mollers M, King AJ, Knol MJ, Scherpenisse M, Meijer CJ, van der Klis FR, de Melker HE. Effectiveness of human papillomavirus vaccine against incident and persistent infections among young girls: Results from a longitudinal Dutch cohort study. Vaccine. 2015 May 28;33(23):2678-83. doi: 10.1016/j.vaccine.2015.04.016. Epub 2015 Apr 14.

ReferenceCitation: Wang KD, Xu DJ, Wang BY, Yan DH, Lv Z, Su JR. Inhibitory Effect of Vaginal Lactobacillus Supernatants on Cervical Cancer Cells. Probiotics Antimicrob Proteins. 2018 Jun;10(2):236-242. doi: 10.1007/s12602-017-9339-x.

lead_sponsor: Centre Hospitalier Régional d'Orléans

status_simplified: Ongoing


title: Valedia Dietary Supplement Tolerance Study Based on Blood, Urinary and Hemodynamic Biological Parameters

summary:
The objectives of this clinical study are to determine the tolerance of dietary supplement Valedia (blend of plant extracts) through the evaluation of several parameters :

Various blood biological parameters for tolerance (preprandial): blood glucose, insulin, fructosamine, total cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol, oxidized LDL, us-CRP, creatinine, ASAT, ALAT, gGT, phosphatase alcaline, bilirubine, urea.
Urinary parameters: urea, creatinine.
Hemodynamic parameters: heart rate and blood pressure.
Cardiac function: ECG.
Weight.

ipd_sharing: Yes

lead_sponsor: Valbiotis

intervention_type: Dietary Supplement


ipd_sharing: No

title: Single-agent Rituximab as Maintenance Treatment Versus Observation After Combined Induction Immunochemotherapy With Fludarabine, Cyclophosphamide and Rituximab in Patients Older Than 65 Years With Previously Untreated Chronic Lymphocytic Leukemia: a Phase III Trial of FILO

lead_sponsor: University Hospital, Tours

type: EudraCT Number

source: euctr

ReferenceType: derived

ReferenceCitation: Dartigeas C, Van Den Neste E, Léger J, Maisonneuve H, Berthou C, Dilhuydy MS, De Guibert S, Leprêtre S, Béné MC, Nguyen-Khac F, Letestu R, Cymbalista F, Rodon P, Aurran-Schleinitz T, Vilque JP, Tournilhac O, Mahé B, Laribi K, Michallet AS, Delmer A, Feugier P, Lévy V, Delépine R, Colombat P, Leblond V; CLL 2007 SA investigators; French Innovative Leukemia Organization (FILO). Rituximab maintenance versus observation following abbreviated induction with chemoimmunotherapy in elderly patients with previously untreated chronic lymphocytic leukaemia (CLL 2007 SA): an open-label, randomised phase 3 study. Lancet Haematol. 2018 Feb;5(2):e82-e94. doi: 10.1016/S2352-3026(17)30235-1. Epub 2017 Dec 20.

summary:
RATIONALE: Classical chemotherapy does not cure advanced chronic lymphocytic leukemia (CLL) despite new drugs. Rituximab is a monoclonal antibody directed against CD20 surface antigen on B lymphocytes and leads to apoptosis of CD20 positive B lymphocytes. The highest response rate yet published in the treatment of first-line CLL has been obtained by the association of fludarabine, cyclophosphamide and rituximab (FCR). Now, the question is whether this response can be improved, as some trials showed that eradication of minimal residual disease (MRD) in CLL is associated with a longer treatment-free and overall survival. Maintenance therapy using rituximab has been recently approved as a means of prolonging remission in patients with indolent non Hodgkin's lymphoma. Maintenance therapy with rituximab could be of interest in treatment of MRD in CLL and prolonging remission and survival times.

PURPOSE: The overall purpose of the study is to determine the value of immunotherapy maintenance with single agent rituximab in comparison with no further treatment (observation ) for previously untreated chronic lymphocytic leukaemia in elderly (>65 years) patients who respond to induction immunochemotherapy with FCR.


title: The Influence of Metabolic Syndrome and Circulating Bile Acid Levels on the Development of Hepatocellular Carcinoma and Biliary Tract Cancers

acronym: METSLIVER

summary:
Increasing rates of highly malignant hepatocellular carcinoma (HCC) and biliary tract cancers (GBTC) observed in Western populations may be related to obesogenic lifestyle factors and their metabolic consequences, such as metabolic syndrome (MetS), inflammation and altered production of bile acids (BA). Such lifestyle behaviours may induce changes in the gut microflora which in turn affect BA profiles, increasing their carcinogenicity. Some elevated BA may be oncogenic in exposed liver, bile ducts and gall bladder. Vertical sleeve gastrectomy may change bile acid composition.

The aims of this study are:

whether specific presurgical bila acid profiles are predictive of efficacy of vertical sleeve gastrectomy, reflective of liver function and metabolic dysfunction;
whether specific presurgical bile acid profiles are predictive of the efficacy of sleeve gastrectomy


title: Study of Bipolar Disorders and Retinal Electrophysiological Markers

acronym: BIMAR

summary:
The BIMAR study aims to compare electrophysiological data measured with electroretinogram (ERG) and electroencephalogram (EEG) between a group of euthymic patients with bipolar disorder (BD) and a group of healthy controls subjects.

Secondarily, the investigators also want to:

Compare combined electrophysiological measurements with ERG and EEG between the two groups.
Identify relations between clinical, neuropsychological and circadian phenotypes in patients with BD and electrophysiological measurements measured with ERG and EEG.

The main hypothesis of the investigators is that differences exist in the ERG and EEG measurements between subjects with BD and healthy subjects. Those differences could be identified as candidate markers for BD which, if confirmed in later studies, could be used in current practice to guide the management of patients with BD.

design_allocation: Non-Randomized

primary_purpose: Diagnostic

ReferenceCitation: Schwitzer T, Schwan R, Bubl E, Lalanne L, Angioi-Duprez K, Laprevote V. Looking into the brain through the retinal ganglion cells in psychiatric disorders: A review of evidences. Prog Neuropsychopharmacol Biol Psychiatry. 2017 Jun 2;76:155-162. doi: 10.1016/j.pnpbp.2017.03.008. Epub 2017 Mar 20.

ReferenceCitation: Tan A, Schwitzer T, Conart JB, Angioi-Duprez K. Study of retinal structure and function in patients with major depressive disorder, bipolar disorder or schizophrenia: A review of the literature. J Fr Ophtalmol. 2020 May;43(5):e157-e166. doi: 10.1016/j.jfo.2020.04.004. Epub 2020 May 4.

ReferenceCitation: Hébert M, Mérette C, Gagné AM, Paccalet T, Moreau I, Lavoie J, Maziade M. The Electroretinogram May Differentiate Schizophrenia From Bipolar Disorder. Biol Psychiatry. 2020 Feb 1;87(3):263-270. doi: 10.1016/j.biopsych.2019.06.014. Epub 2019 Jun 27.

ReferenceCitation: Gross G, Tursini K, Albuisson E, Angioi-Duprez K, Conart JB, Louis Dorr V, Schwan R, Schwitzer T. Bipolar disorders and retinal electrophysiological markers (BiMAR): Study protocol for a comparison of electroretinogram measurements between subjects with bipolar disorder and a healthy control group. Front Psychiatry. 2022 Sep 8;13:960512. doi: 10.3389/fpsyt.2022.960512. eCollection 2022.

lead_sponsor: Centre Psychothérapique de Nancy

intervention_type: Behavioral


primary_purpose: Supportive Care

title: Reaching Protein Target With SmofKabiven® Extra Nitrogen Versus Olimel N9E: A Prospective, Randomised, Active-controlled, Patient-blinded, Multicentre Clinical Trial During the Early Phase of Acute Critical Illness

lead_sponsor: Fresenius Kabi

location_country: Germany Poland France

location_facility: SP ZOZ Wojewódzki Szpital Zespolony im. J. Śniadeckiego

location_facility: Klinikum rechts der Isar, Klinik für Anaesthesiologie

location_facility: Hôpital Saint-Antoine, Département d'Anesthésie-Réanimation

summary: The main focus of the study is to show that SmofKabiven® extra Nitrogen, in a realistic clinical setting, enables to meet high protein requirements in patients during the first week after onset of critical illness, without risk of overfeeding with energy.


title: Assessment of Prostatic Tissue Concentration of Ertapenem After a Pre-operative Administration

acronym: ERTAPRO

summary: The purpose of this study is to demonstrate the prostatic diffusion in significant concentration of ertapenem achieved after a pre-operative single administration.

primary_purpose: Prevention

ReferenceCitation: Alhambra A, Cuadros JA, Cacho J, Gómez-Garcés JL, Alós JI. In vitro susceptibility of recent antibiotic-resistant urinary pathogens to ertapenem and 12 other antibiotics. J Antimicrob Chemother. 2004 Jun;53(6):1090-4. Epub 2004 Apr 29.

ReferenceCitation: Tomera KM, Burdmann EA, Reyna OG, Jiang Q, Wimmer WM, Woods GL, Gesser RM; Protocol 014 Study Group. Ertapenem versus ceftriaxone followed by appropriate oral therapy for treatment of complicated urinary tract infections in adults: results of a prospective, randomized, double-blind multicenter study. Antimicrob Agents Chemother. 2002 Sep;46(9):2895-900.

ReferenceCitation: Jimenez-Cruz F, Jasovich A, Cajigas J, Jiang Q, Imbeault D, Woods GL, Gesser RM; Protocol 021 Study Group. A prospective, multicenter, randomized, double-blind study comparing ertapenem and ceftriaxone followed by appropriate oral therapy for complicated urinary tract infections in adults. Urology. 2002 Jul;60(1):16-22.

ReferenceCitation: Wells WG, Woods GL, Jiang Q, Gesser RM. Treatment of complicated urinary tract infection in adults: combined analysis of two randomized, double-blind, multicentre trials comparing ertapenem and ceftriaxone followed by appropriate oral therapy. J Antimicrob Chemother. 2004 Jun;53 Suppl 2:ii67-74.


title: Evaluation of the Prevalence of an Hyperactivation of NCC Cotransporter Three Months After Kidney Transplantation in Recipients Treated by Calcineurin Inhibitors

acronym: MANGUE

summary: Hypertension is common disorder after renal transplantation and is associated with mortality. Calcineurin Inhibitor (CNI), by activating NCC cotransporter, may be a major determinant of hypertension, included in a "Gordon like" syndrome. However, prevalence of NCC activation by CNI is unknown. Our objective is to determine the prevalence of NCC activation three months after transplantation in patient treated by CNI.

lead_sponsor: University Hospital, Bordeaux

location_country: France Réunion

location_facility: Hopital Pellegrin - Service Néphrologie, transplantation, dialyse et aphérèse

location_facility: Hopital Felix Guyon - Service d'Explorations Fonctionnelles Rénales

intervention_type: Other


title: Gentamicine-EDTA, a New Anti-biofilm Strategy for the Conservative Treatment of Catheter-related Infections

acronym: CATH-GE

summary: Catheter-related infections are frequent. Treatment without catheter removal is difficult because of the presence of biofilm. The association of gentamicin and EDTA is active in vitro and in vivo against biofilms formed by Gram positive and Gram negative bacteria.

ipd_sharing: Undecided

lead_sponsor: Institut Pasteur

location_facility:
Hôpital Saint-Louis
Hôpital Cochin
Hôpital Beaujon
Hôpital Henri Mondor
HEGP


type: Registry Identifier

title: Transcranial Magnetic Stimulation (rTMS) and Autism.Implication of the Superior Temporal Sulcus in Normal and Abnormal Social Perception

acronym: TMSAUTISME

summary: In this protocol we aim to use rTMS to better characterize STS role in normal and abnormal social cognition. With that purpose, we will measure the effect of inhibitory and excitatory rTMS on the fixation time on social scenes (using eye-tracking methodology) or on the ability to recognize human voice/sounds.

intervention_type: Device


title: Withings Study to Analyse the Accuracy of Screening Small Fiver Neuropathy With a Bathroom Scale

acronym: WISUDO

summary: The aim of this study is to evaluate the diagnostic performance of Withings WBS08 to screen small fiber neuropathy.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Withings

location_facility:
Henri-Mondor Hospital
Lariboisière Hospital
Cochin Hospital
Bichat-Claude Bernard Hospital

intervention_type: Diagnostic Test


title: REtinal and VIsual Cortical Response in Early PSYchosis

acronym: REVIPSY

summary: The purpose of the REVIPSY study is to measure retinal and the visual cortical electrophysiological responses in situations at risk of psychosis in patients who have experienced a first psychotic episode. A perspective of this project will be to create new electrophysiological biomarkers predictive of the risk of conversion to psychosis

ReferenceCitation: Laprevote V, Heitz U, Di Patrizio P, Studerus E, Ligier F, Schwitzer T, Schwan R, Riecher-Rössler A. [Why and how to treat psychosis earlier?]. Presse Med. 2016 Nov;45(11):992-1000. doi: 10.1016/j.lpm.2016.07.011. Epub 2016 Aug 21. Review. French.

ReferenceCitation: Demmin DL, Davis Q, Roché M, Silverstein SM. Electroretinographic anomalies in schizophrenia. J Abnorm Psychol. 2018 May;127(4):417-428. doi: 10.1037/abn0000347.

ReferenceCitation: Moghimi P, Torres Jimenez N, McLoon LK, Netoff TI, Lee MS, MacDonald A 3rd, Miller RF. Electoretinographic evidence of retinal ganglion cell-dependent function in schizophrenia. Schizophr Res. 2020 May;219:34-46. doi: 10.1016/j.schres.2019.09.005. Epub 2019 Oct 12.

ReferenceCitation: Tan A, Schwitzer T, Conart JB, Angioi-Duprez K. [Retinal investigations in patients with major depressive disorder, bipolar disorder or schizophrenia: A review of the literature]. J Fr Ophtalmol. 2020 Sep;43(7):586-597. doi: 10.1016/j.jfo.2019.10.029. Epub 2020 Jul 4. Review. French.

ReferenceCitation: Butler PD, Martinez A, Foxe JJ, Kim D, Zemon V, Silipo G, Mahoney J, Shpaner M, Jalbrzikowski M, Javitt DC. Subcortical visual dysfunction in schizophrenia drives secondary cortical impairments. Brain. 2007 Feb;130(Pt 2):417-30. Epub 2006 Sep 19.

ReferenceCitation: Knebel JF, Javitt DC, Murray MM. Impaired early visual response modulations to spatial information in chronic schizophrenia. Psychiatry Res. 2011 Sep 30;193(3):168-76. doi: 10.1016/j.pscychresns.2011.02.006. Epub 2011 Jul 20.

ReferenceCitation: Kim DW, Shim M, Song MJ, Im CH, Lee SH. Early visual processing deficits in patients with schizophrenia during spatial frequency-dependent facial affect processing. Schizophr Res. 2015 Feb;161(2-3):314-21. doi: 10.1016/j.schres.2014.12.020. Epub 2014 Dec 29.


title: Genes Modulating the Severity of Aortic Aneurysms (MSF1-TGFBR2)

summary:
This project concerns a population at risk of sudden death by dissection of the thoracic aorta. Its interest is to make it possible to recognize the genes that protect or worsen the evolution of aneurysms, to better understand the mechanisms involved, to detect and treat aneurysms of the thoracic aorta, wich is a pathology that is completely silent clinically until life-threatening complications.

The variability in the severity of the disease within the same family is related to modifier genes.

The objective is to find the modifying factors that account for the variability in the severity of the progression of aneurysms of the thoracic aorta.

lead_sponsor: French Cardiology Society


title: Efficacy of Tacrolimus Ointment 0.1% Versus Placebo in Adults With Facial Non-segmental Vitiligo: a Randomized Double-blind Controlled Study

acronym: VITAC

summary: Multicentric French parallel double-blind randomized versus placebo study

ReferenceCitation: Seneschal J, Duplaine A, Maillard H, Passeron T, Andreu N, Lassalle R, Favary C, Droitcourt C, Taïeb A, Ezzedine K. Efficacy and Safety of Tacrolimus 0.1% for the Treatment of Facial Vitiligo: A Multicenter Randomized, Double-Blinded, Vehicle-Controlled Study. J Invest Dermatol. 2021 Jul;141(7):1728-1734. doi: 10.1016/j.jid.2020.12.028. Epub 2021 Feb 4.

location_facility: University Hospital Center of Rennes - Hôpital Pontchaillou

location_facility: University Hospital of Bordeaux - St André Hospital

location_facility: University Hospital Center of Nice - Hôpital de l'Archet


title: Phase II Open-label Randomized Multicenter Trial to Compare the Efficacy and Safety of Two Different Doses of Raltegravir and Efavirenz, All in Combination With Tenofovir and Lamivudine, in Naive HIV-1-infected Patients Receiving Rifampin for Active Tuberculosis

summary:
Raltegravir is a potent antiretroviral agent that could be used as an alternative to efavirenz in HIV-1 infected patients with tuberculosis. However due to pharmacokinetic interactions, the optimal dose of raltegravir to be used in combination with rifampin is currently unknown.

This phase II open-label randomized multicenter trial is designed to estimate the antiviral efficacy of two doses of raltegravir and one dose of efavirenz at week 24, in HIV-1 naive patients co-infected with active tuberculosis (TB) treated with rifampin.

ReferenceCitation: Grinsztejn B, De Castro N, Arnold V, Veloso VG, Morgado M, Pilotto JH, Brites C, Madruga JV, Barcellos NT, Santos BR, Vorsatz C, Fagard C, Santini-Oliveira M, Patey O, Delaugerre C, Chêne G, Molina JM; ANRS 12 180 Reflate TB study group. Raltegravir for the treatment of patients co-infected with HIV and tuberculosis (ANRS 12 180 Reflate TB): a multicentre, phase 2, non-comparative, open-label, randomised trial. Lancet Infect Dis. 2014 Jun;14(6):459-67. doi: 10.1016/S1473-3099(14)70711-X. Epub 2014 Apr 9. Erratum in: Lancet Infect Dis. 2014 Jun;14(6):448.

lead_sponsor: ANRS, Emerging Infectious Diseases

location_country: France Brazil

location_facility:
Hospital Sanatorio Pertenon
CHI Villeneuve Saint Georges
Hospitral Universitario Pr Edgar Santos
Hospital Nossa Senhora da Coceiçao
STD/AIDS department
Hospital Genral de Nova Iguaçu
Ipec/Fiocruz
Hôpital Saint-Louis
Hôpital Lariboisière


title: The Clinical and Socio-demographic Characteristics of Young People Aged 12 to 25 Consulting on Ambulatory Structures in the Seine Saint-Denis

summary:
A prospective study of the clinical and socio-demographic characteristics of young people aged 12 to 25 consulting on ambulatory structures in the Seine Saint-Denis.

This research project, intersectoral and inter-institutional, built in a territorial logic, is therefore intended to study longitudinally over a year the population of young consultants in the different units participating in it, to highlight their common profiles and differences.

This will be the first clinical research work concerning adolescents and young adults using mental health services in the Seine Saint Denis Ouest.

status: Unknown status

primary_purpose: Other

lead_sponsor: Januel

location_facility:
CMP Adulte Saint-Denis
Relais Collégiens-Lycéens
CASADO
URC Ville Evrard
CMP Adulte Saint-Ouen


title: Clinical Significance of Heterozygosity for Mutations of the SLC12A3 Gene Coding for the Thiazide Sensitive Na-Cl Cotransporter

acronym: HEPHYGI

summary: Gitelman syndrome is a salt wasting tubulopathy caused by mutations in the SLC12A3 gene coding for the thiazide sensitive sodium chloride cotransporter. This disease mimics the chronic treatment with thiazide diuretics and is characterized by renal hypokalemia, low to normal blood pressure, hypocalciuria and hypomagnesemia. The purpose of this study is to determine whether the heterozygous carriers present the metabolic risks and/or the benefits of this disease.

ReferenceCitation: Tago N, Kokubo Y, Inamoto N, Naraba H, Tomoike H, Iwai N. A high prevalence of Gitelman's syndrome mutations in Japanese. Hypertens Res. 2004 May;27(5):327-31.

ReferenceCitation: Fava C, Montagnana M, Rosberg L, Burri P, Almgren P, Jönsson A, Wanby P, Lippi G, Minuz P, Hulthèn LU, Aurell M, Melander O. Subjects heterozygous for genetic loss of function of the thiazide-sensitive cotransporter have reduced blood pressure. Hum Mol Genet. 2008 Feb 1;17(3):413-8. Epub 2007 Nov 1.

ReferenceCitation: Ji W, Foo JN, O'Roak BJ, Zhao H, Larson MG, Simon DB, Newton-Cheh C, State MW, Levy D, Lifton RP. Rare independent mutations in renal salt handling genes contribute to blood pressure variation. Nat Genet. 2008 May;40(5):592-599. doi: 10.1038/ng.118. Epub 2008 Apr 6.

ReferenceCitation: Hsu YJ, Yang SS, Chu NF, Sytwu HK, Cheng CJ, Lin SH. Heterozygous mutations of the sodium chloride cotransporter in Chinese children: prevalence and association with blood pressure. Nephrol Dial Transplant. 2009 Apr;24(4):1170-5. doi: 10.1093/ndt/gfn619. Epub 2008 Nov 25.

ReferenceCitation: Ren H, Qin L, Wang W, Ma J, Zhang W, Shen PY, Shi H, Li X, Chen N. Abnormal glucose metabolism and insulin sensitivity in Chinese patients with Gitelman syndrome. Am J Nephrol. 2013;37(2):152-7. doi: 10.1159/000346708. Epub 2013 Jan 31.

ReferenceCitation: Cruz DN, Simon DB, Nelson-Williams C, Farhi A, Finberg K, Burleson L, Gill JR, Lifton RP. Mutations in the Na-Cl cotransporter reduce blood pressure in humans. Hypertension. 2001 Jun;37(6):1458-64.

location_facility: Clinical Research Center. Assistance Publique Hôpitaux de Paris, Hôpital Européen Georges Pompidou.

location_facility: Department of Functional Investigations. Hospices Civils de Lyon, Hôpital Edouard Herriot.

location_facility: Department of Functional Investigations. Assistance Publique Hôpitaux de Paris, Hôpital Tenon

location_facility: Department of Functional Investigations. Centre Hospitalier Universitaire, Hôpital de Rangueil.

location_facility: Nephrology Department. Centre Hospitalier Universitaire, Hôpital Dupuytren


title: Capillary Glycerolemia Evolution During Physical Exercise

acronym: LSEEGLYCEROL

summary:
Maximum fatty acid oxidation is known to occur at exercise intensities between 45 and 65% VO2max and in the fasting state.

However, the optimal level may depend on various unknown factors. Glycerolemia is a good marker of the fatty acid metabolism but its evolution remains poorly described, maybe due to the difficulty of the measure.

A new device allows an easy measurement of glycerolemia during exercise and could enable personalization strategies to optimize exercise efficacy.

In this study, the investigators plan to test three different exercise types and three different fasting conditions with three replicates each to evaluate the variability of glycerolemia and its evolution during exercise.


title: Chest CT-scan for the Diagnosis of Community-acquired Pneumonia in Patients Visiting the Emergency Department

acronym: PACSCAN

summary:
Primary objective : to estimate impact of CT-scan on diagnostic for emergency department (ED) patients with suspected Community-acquired Pneumonia (CAP).

Secondary objective: to estimate impact of CT-scan on treatment (antimicrobial therapy) and site of care for ED patients with suspected CAP.

ReferenceCitation: Tubiana S, Epelboin L, Casalino E, De Saint Aurin BG, Naccache JM, Feydy A, Khalil A, Hausfater P, Duval X, Claessens YE; ESCAPED study group. Effect of diagnosis level of certainty on adherence to antibiotics' guidelines in ED patients with pneumonia: a post-hoc analysis of an interventional trial. Eur J Emerg Med. 2022 Jun 27. doi: 10.1097/MEJ.0000000000000954. [Epub ahead of print]

ReferenceCitation: Le Bel J, Pelaccia T, Ray P, Mayaud C, Brun AL, Hausfater P, Casalino E, Benjoar M, Claessens YE, Duval X; ESCAPED study group. Impact of emergency physician experience on decision-making in patients with suspected community-acquired pneumonia and undergoing systematic thoracic CT scan. Emerg Med J. 2019 Aug;36(8):485-492. doi: 10.1136/emermed-2018-207842. Epub 2019 Jun 24.

ReferenceCitation: Le Bel J, Hausfater P, Chenevier-Gobeaux C, Blanc FX, Benjoar M, Ficko C, Ray P, Choquet C, Duval X, Claessens YE; ESCAPED study group. Diagnostic accuracy of C-reactive protein and procalcitonin in suspected community-acquired pneumonia adults visiting emergency department and having a systematic thoracic CT scan. Crit Care. 2015 Oct 16;19:366. doi: 10.1186/s13054-015-1083-6.

ReferenceCitation: Claessens YE, Debray MP, Tubach F, Brun AL, Rammaert B, Hausfater P, Naccache JM, Ray P, Choquet C, Carette MF, Mayaud C, Leport C, Duval X. Early Chest Computed Tomography Scan to Assist Diagnosis and Guide Treatment Decision for Suspected Community-acquired Pneumonia. Am J Respir Crit Care Med. 2015 Oct 15;192(8):974-82. doi: 10.1164/rccm.201501-0017OC.

ReferenceCitation: Das D, Le Floch H, Houhou N, Epelboin L, Hausfater P, Khalil A, Ray P, Duval X, Claessens YE, Leport C; ESCAPED Study Group. Viruses detected by systematic multiplex polymerase chain reaction in adults with suspected community-acquired pneumonia attending emergency departments in France. Clin Microbiol Infect. 2015 Jun;21(6):608.e1-8. doi: 10.1016/j.cmi.2015.02.014. Epub 2015 Feb 20.

location_facility:
Bichat Hospital
Cochin Hospital
La Pitié Salpêtrière Hospital
Tenon Hospital


title: Transcultural and Psychometric Validation of SUSHI and HOOS-12 Scores in Patients With Coxofemoral Pathologies

acronym: HIP

summary:
The management of coxofemoral pathologies is constantly increasing.

In addition to degenerative hip pathology, the orthopedic surgeon is now confronted with pathologies such as femoro-acetabular conflict, pathologies of the gluteus medius and pathologies of the labrum whose early management limits arthritis degeneration. These pathologies are mainly encountered in young subjects (<60 years).

Self-questionnaires play an important role in understanding patients' point of view on the impact of their coxofemoral pathologies and also allow an assessment of their condition after treatment.

For the evaluation of coxofemoral pathologies in the young subject (<60 years) the Super Simple Hip score (SUSHI-score) was developed and validated.

In the elderly subject with hip osteoarthritis, the HOOS score has the advantage of specifically measuring pain, symptoms, function and quality of life, but is made up of 40 items and is often considered rather heavy to submit. However, it has recently been simplified and the HOOS-12 (HOOS score with 12 items) has been developed and validated.

These two scores are useful in current clinical practice but they are only validated in English.

lead_sponsor: University Hospital Center of Martinique

location_country: France Martinique

location_facility:
Centre Hospitalier Privé Saint-Grégoire
Hôpital Lariboisière - AP-HP
CHU of Martinique


title: A Prospective, Multicenter Observational Trial Assessing the Safety and Efficacy of Gammanorm® in Autoimmune Diseases

summary: This observational trial assesses the safety and efficacy of Gammanorm® in autoimmune diseases.

lead_sponsor: Octapharma

location_facility: CHU de la Martinique- Hopital Pierre Zobda Quitman


title: Assessment of the Prognosis of Persistent Left Bundle Branch Block (LBBB) After Transcatheter Aortic Valve Implantation (TAVI ) by an Electrophysiological and Remote Monitoring Risk-adapted Algorithm

acronym: LBBB-TAVI

summary:
The replacement of the aortic valve by percutaneous approach (called TAVI) is a therapy which is booming in the management of aortic stenosis. It concerns patients who have a high surgical risk presenting comorbidity, for whom a classic approach by surgery of valvular replacement seems unreasonable. Beyond its feasibility, the implantation of a TAVI is less invasive and improves the patient's morbi-mortality. The appearance of a Left Bundle Branch Block (LBBB) is one of the most frequent complications of this procedure and represents an important risk of atrio-ventricular (AV) high grade conductive disorders requiring permanent pacing in 5 in 15 % of the cases in 1 year.

De novo LBBB is associated with a more important morbi-mortality in post-TAVI situation. However, there are no predictive elements of these conductive disorders. Besides, the incidence and the deadline of appearance of this AV disorders are not established. It seems relevant to propose a new stratification based on ECG and endocavitary data. The monitoring of the conductive disorders is allowed by remote monitoring thanks to the implantation of a pacemaker or an implantable holter allowing to determine the incidence and the deadline of appearance of high grade AV conduction disorders.

ReferenceCitation: Massoullié G, Bordachar P, Irles D, Caussin C, Da Costa A, Defaye P, Jean F, Mechulan A, Mondoly P, Souteyrand G, Pereira B, Ploux S, Eschalier R. Prognosis assessment of persistent left bundle branch block after TAVI by an electrophysiological and remote monitoring risk-adapted algorithm: rationale and design of the multicentre LBBB-TAVI Study. BMJ Open. 2016 Oct 26;6(10):e010485. doi: 10.1136/bmjopen-2015-010485.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Comparing the Impact of Weight Loss Induced by Bariatric Surgery or Through a Standard Nutritional Management on Sexual Function and Sperm Quality in Men With Severe Obesity - Multicenter, Prospective

acronym: SexOb

summary: Study of the impact of weight loss induced by surgery (interventional group) or optimal nutritional management (control group) on sexual function in men with severe obesity

lead_sponsor: University Hospital, Lille

location_facility:
Chu Rouen
CHRU, Hôpital Claude Huriez
Chu de Caen Normandie


title: Effectiveness of Two Stress Management Programs in the Adaptation Disorder With Anxiety (ADA) : Computer-based or Face- to -Face to Face Versus Control Group.Open Multicenter Prospective Randomized Controlled Therapeutic 3 Parallel Groups

summary: The aim of this study was to assess the effects of a 5-week standardized cognitive behavioral treatment of stress management conducted via e-learning or face-to-face on patients responding to the diagnosis of adjustment disorder with anxiety (ADA) according to the DSM- 5 (Diagnostic and Statistical Manual of Mental Disorders Fifth Edition) criteria .

ReferenceCitation: Day V, McGrath PJ, Wojtowicz M. Internet-based guided self-help for university students with anxiety, depression and stress: a randomized controlled clinical trial. Behav Res Ther. 2013 Jul;51(7):344-51. doi: 10.1016/j.brat.2013.03.003. Epub 2013 Mar 28.

ReferenceCitation: Drozd F, Raeder S, Kraft P, Bjørkli CA. Multilevel growth curve analyses of treatment effects of a Web-based intervention for stress reduction: randomized controlled trial. J Med Internet Res. 2013 Apr 22;15(4):e84. doi: 10.2196/jmir.2570.

ReferenceCitation: Eisen KP, Allen GJ, Bollash M, Pescatello LS. Stress management in the workplace: A comparison of a computer-based and an in-person stress-management intervention. Comput Hum Behav. 2008 Mar;24(2):486-96.

ReferenceCitation: Grime PR. Computerized cognitive behavioural therapy at work: a randomized controlled trial in employees with recent stress-related absenteeism. Occup Med (Lond). 2004 Aug;54(5):353-9.

ReferenceCitation: Rose RD, Buckey JC Jr, Zbozinek TD, Motivala SJ, Glenn DE, Cartreine JA, Craske MG. A randomized controlled trial of a self-guided, multimedia, stress management and resilience training program. Behav Res Ther. 2013 Feb;51(2):106-12. doi: 10.1016/j.brat.2012.11.003. Epub 2012 Nov 21.

ReferenceCitation: Ruwaard J, Lange A, Bouwman M, Broeksteeg J, Schrieken B. E-mailed standardized cognitive behavioural treatment of work-related stress: a randomized controlled trial. Cogn Behav Ther. 2007;36(3):179-92.

ReferenceCitation: Servant D, Rougegrez L, Barasino O, Demarty AL, Duhamel A, Vaiva G. [Interest of computer-based cognitive behavioral stress management. Feasability of the Seren@ctif program]. Encephale. 2016 Oct;42(5):415-420. doi: 10.1016/j.encep.2016.03.010. Epub 2016 Apr 25. French.

ReferenceCitation: Leterme AC, Behal H, Demarty AL, Barasino O, Rougegrez L, Labreuche J, Duhamel A, Vaiva G, Servant D. A blended cognitive behavioral intervention for patients with adjustment disorder with anxiety: A randomized controlled trial. Internet Interv. 2020 May 25;21:100329. doi: 10.1016/j.invent.2020.100329. eCollection 2020 Sep.

ReferenceCitation: Servant D, Leterme AC, Barasino O, Rougegrez L, Duhamel A, Vaiva G. Efficacy of Seren@ctif, a Computer-Based Stress Management Program for Patients With Adjustment Disorder With Anxiety: Protocol for a Controlled Trial. JMIR Res Protoc. 2017 Oct 2;6(10):e190. doi: 10.2196/resprot.7976.

location_facility:
Centre Pinel
Centre Esquirol CHU de Caen
CHRU , Hôpital FONTAN


title: Evaluation of Brain Opioid Receptor Activity in Anorexia Nervosa : a PET [11C]Diprenorphine Study

summary: The place of opioid system in anorexia nervosa (AN) physiopathology is still unclear. Conflicting results were published on cerebral spinal fluid or peripheral levels in anorexia nervosa. However, no data have been reported on opioid cerebral activity. Diprenorphine is a ligand with non-selective binding to opiate receptors µ, κ and δ capable to assess the interaction between endogenous opioids and their receptors.

ReferenceCitation: Galusca B, Traverse B, Costes N, Massoubre C, Le Bars D, Estour B, Germain N, Redouté J. Decreased cerebral opioid receptors availability related to hormonal and psychometric profile in restrictive-type anorexia nervosa. Psychoneuroendocrinology. 2020 Aug;118:104711. doi: 10.1016/j.psyneuen.2020.104711. Epub 2020 May 19.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU Clermont Ferrand
CNRH
CHU Saint-Etienne


title: Interest of Morphometric Analysis of Sputum Cytology for Lung Cancer Screening in Workers Highly Exposed to Asbestos - Exploratory Analysis of Biomarkers Predictive for Lung Cancer

acronym: AMORCE-CBP

summary:
Workers exposed to asbestos are at high risk of lung cancer. Medical follow-up of this population relies on repeated CT-scans which are more accurate for detection of peripheral lesions, and expose to X-rays and to risk of false-positives. Analysis of sputum using automate cytometry may be of interest in this population, alone or in combination with CT-scan.

An ancillary study will evaluate the interest of blood predictive biomarkers.

primary_purpose: Screening

lead_sponsor: University Hospital, Caen

location_facility:
Caen University Hospital
Rouen University Hospital
Le Havre Hospital


title: Assessment of Blood Loss With a Point Of Care Device During Hip/Knee Surgery Performed On Dual/Single Antiplatelet Therapy

acronym: BLOOD

summary: Main Objective: The purpose of this study is to demonstrate whether there is a correlation between perioperative blood loss and the degree of platelet inhibition assessed by a point of care assay in patients undergoing hip or knee arthroplasty and treated by antiplatelet mono/bi-therapy

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: pôle Anesthesie -Réanimation- CHU Pitie -Salpetrière

location_facility: Institute of cardiology - Pitié Salpêtrière Hospital

location_facility: CHU Toulouse - Hôpital de Rangueil - Anésthésie-Réanimation


title: Curative Efficacy of Pravastatine in Patients Presented Delayed Cutaneous and Subcutaneous Radio-induced Fibrosis

acronym: PRAVACUR

summary:
Molecular mechanisms involved in radio-induced fibrosis are assessed in UPRES EA 27-10 since 10 years. Besides the canonical TGFbeta/ Smad pathway involved in radio-induced fibrosis (RIF), the Rho/ROCK/CTGF cascade has been shown to be also implicated in molecular mechanisms of RIF. Curative administration of Pravastatin or ROCK specific inhibitors inhibits the chronically activated Rho/ROCK/CTGF pathway in vitro in human cells lines and ex vivo in human samples. In addition, the curative administration of Pravastatin improves established RIF in vivo. The investigators data suggest that the pravastatin-based strategy is an efficient and safe antifibrotic therapy, easily transferable into the clinic to improve the quality of life of long-term cancer survivors without interfering with prior anticancer treatment.

This clinical trial evaluates the curative efficacy of Pravastatine in patients who presented a cutaneous and/ or subcutaneous fibrosis (grade >= 2 according to NCI-CTCAE v4 toxicities scale) and who were treated by radiotherapy for a head and neck cancer. Patients will be treated by Pravastatin during 12 months. An intermediate evaluation of efficacy by ultrasound will be assessed at 6 months and at last, at the end of the treatment. Patients assessment will be performed at 6 and 12 months after the end of the treatment to look at a potential rebound effect.

Objective(s) of the clinical study

Main objective: To assess Pravastatin efficacy in established cutaneous and subcutaneous radio-induced fibrosis revealed from 6 to 24 months after head and neck radiotherapy.

Second objective: To evaluate radio-induced fibrosis regression during the year following treatment stop.

ReferenceCitation: Bourgier C, Auperin A, Rivera S, Boisselier P, Petit B, Lang P, Lassau N, Taourel P, Tetreau R, Azria D, Bourhis J, Deutsch E, Vozenin MC. Pravastatin Reverses Established Radiation-Induced Cutaneous and Subcutaneous Fibrosis in Patients With Head and Neck Cancer: Results of the Biology-Driven Phase 2 Clinical Trial Pravacur. Int J Radiat Oncol Biol Phys. 2019 Jun 1;104(2):365-373. doi: 10.1016/j.ijrobp.2019.02.024. Epub 2019 Feb 15.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility:
Institut Gustave Roussy
Centre Val d'Aurelle
Hôpital Européen Georges Pompidou


title: Adaptation of Lipid and Energy Metabolism During a Lipid Overnutrition in Constitutional Thinness

acronym: Surnutrition

summary: For a given food intake, fat and energy metabolism in adipose tissue and muscle adapt to nutrient intakes. This adaptation to nutrition may be impaired in susceptible individuals or in obese patients by promoting weight gain, either in constitutional thinness (MC) by blocking it. The MC is a little known entity. These patients wish to grow for her and others. Can they? We have demonstrated abnormalities of hormones regulating appetite (ghrelin, PYY, GLP1 and leptin) that may participate in thinness. Furthermore, this thinness is associated with osteoporosis in 25% of true MC who is 25 years old.

location_facility:
CHU de Saint-Etienne
CRNH Auvergne
CRNH Rhône-Alpes


title: Evaluation of a Simplified Method for Diagnosis of Sleep Apnea in Children and Adults With Down Syndrome

summary:
People with Down syndrome are at increased risk of sleep apnea, not only from obstruction of the upper airway, but also of central origin. According to published data, sleep apnea may occur in at least 40% of children and adults with Down syndrome. Consequences of these sleep apnea are numerous : failure to thrive, cognitive decline, high blood pressure, heart disease, accident due to day sleepiness, fatigue. This condition is treatable in people with Down syndrome, as it is in ordinary people.

Diagnosis of sleep apnea in people with Down syndrome is therefore a major concern. In addition, data regarding age of apparition of this complication are missing, making repeated screening necessary.

Polysomnography is the method of choice for the diagnosis of sleep apnea. Unfortunately, it is time consuming and sleep departments are heavily busy.

location_facility:
Hospices Civiles de lyon
CHU de Saint-Etienne
CHU de Grenoble


title: Interest of Real Time Measurement of Autonomous Nervous System for the Detection of Brain Death: the MEANS Study

acronym: MEANS

summary:
Context: A major lack of organ donors is a serious public health problem. It determines a prolonged delay before a transplant can be performed and thus a significant number of deaths of patients waiting for transplantation. The aim of this project is to reduce the delay of the diagnosis of brain death, and also to improve its diagnosis in the Intensive Care Unit.

The diagnosis of brain death is strictly defined by the law and relies either on two consecutive flat electroencephalograms recorded at an interval of four hours, or on the lack of cerebral circulation during a brain angiography performed after suspecting brain death on the clinical exam. However, in usual practice, it is difficult to have all the needed clinical arguments, and their interpretation can be difficult in the pathological context. This may participate in the delay and the lack of patients potentially donors.

Pre-study: In a pilot study, fifty subjects with severe cerebral lesions, had a continuous ECG recording. The investigators could find that a decrease in autonomic nervous system activity, as measured through the ECG, was correlated to the transition to brain death assessed by cerebral angiography. The loss of cardiac variability was always observed between two cerebral angiographies, one before and the second after brain death. This study allowed the investigators to calculate the threshold values of sympathetic and parasympathetic activities to confirm brain death.

location_facility:
CHU de Dijon
CHU de Saint-Etienne
CH Roanne


title: Restoration of the Radial Length in Compound Wrist Fractures Using Anterior Locking Plates

summary:
The fractures of the wrist, affecting the distal end of the radius are frequent, in particular in the old subject and/or osteoporotic. Beside the simple fractures treated by mini-invasive surgical methods, there is a considerable number of strong comminuted fractures for which no method of osteosynthesis proves completely satisfactory, especially on osteoporotic bone. However, the restitution of the anatomy remains the principal concern of the surgeon eager to ensure a good functional result to its patient, with the proviso that the least aggressive possible method is used.

Until now, it is of use to rather largely use the external fixer bridging the radiocarpal articulation to maintain the length of the radius, more or less associated with an another method of internal osteosynthesis with minima. The major disadvantage of this kind of assembly is the high rate of neuroalgodystrophic syndromes of the wrist and losses of reduction, sometimes generators of painful after-effects and serious stiffening. These after-effects which are sometimes definitive can be very disabling when they occur among active people, a fortiori when they touch the dominant side.

The recent alternative to the use of the external fixer is the use of the plates with locking screws, affixed on the foreface of the radius, maintaining the length of the radius but not bridging the articulation. Thus, this kind of osteosynthesis does not generate ligamentary distraction nor of the radiocarpal capsule, factors which would be prevalent in the release of the algodystrophy and of the stiffening. On the other hand, this method of osteosynthesis is more invasive than the installation of an external fixer, because it requires the access of the foreface of the radius and cannot be practised in a percutaneous way. At present, there is any randomized comparative study, the published studies being only comparative retrospective and not controlled, carried out on nonhomogeneous series of fractures.

The principal objective of our study is to evaluate the interest of the locking plates in the maintenance of the radial length in the comminuted fractures of the distal end of the radius.

It is about a prospective, multicentric, randomized study in 2 parallel groups carried out patients from 40 to 80 years hospitalized in a service of Osseous Surgery.

Patients: articular displaced fractures of the lower end of the radius with strong metaphysar comminution (groups M3 and M4 of the classification MEC) with an important shortening of the radius, measured by a radio-ulnar index higher than 4 mm compared to the opposite side. Are excluded the articular explosions type E4. The patients of more than 40 years, autonomous and active, able to give an assent for the participation in a clinical study are included.

Treatment. The first group of patients would be treated by fore locked plate possibly associated with pins. The immobilization would be limited to a antibrachiopalmar splint for 45 days. If, peroperatively, a sufficient stability of the fracture cannot be obtained by the plate alone, and that a complementary stabilization by fixer proves to be necessary, then the case will be entered like a failure of stabilization by locked plate.

The second group of patients would be treated by external radiocarpal fixer in neutralization possibly associated with an internal osteosynthesis with minima (percutaneous pins). The fixer would be left in place during 45 days.

The reeducation would consist in the 2 groups of an active mobilization of the fingers at the beginning, then of an active reeducation of the wrist in flexion/extension and pronosupination starting from the 45th day.

About fifty patients should be included in each group, with a collection of the clinical and radiographic results at 21 days, 45 days, 3 months and 6 months.

lead_sponsor: University Hospital, Angers

location_facility:
UH of Besancon
UH of Angers
UH of Tours


title: Assessment of Subthalamic Nucleus Stimulation in Drug Resistant Epilepsy Associated With Dopaminergic Metabolism Deficit. A Randomized, Double Blind, Controlled Trial.

summary:
The aim of this study is to evaluate the effectiveness and the safety of deep brain stimulation in drug resistant epilepsy.

This is a double blind, controlled and randomized clinical trial with two cross-over groups and four phases.

Phase 1 : base line, open phase consisting of follow-up of patients with their standard treatment.

Phase 2 : Randomisation, lead implantation, followed by 3 months wash out period with the stimulator switch OFF.

Phase 3 : cross-over, double blind phase : 3 months with stimulator switch ON or OFF depending on randomization allocation, followed by 3 months with the stimulator switch on the opposite position. The placebo consisting of turn OFF the stimulator.

Phase 4 : open phase, one year follow-up of all patients with the stimulator switch ON.

ReferenceCitation: Alexander GE, Crutcher MD. Functional architecture of basal ganglia circuits: neural substrates of parallel processing. Trends Neurosci. 1990 Jul;13(7):266-71. Review.

ReferenceCitation: Ardouin C, Pillon B, Peiffer E, Bejjani P, Limousin P, Damier P, Arnulf I, Benabid AL, Agid Y, Pollak P. Bilateral subthalamic or pallidal stimulation for Parkinson's disease affects neither memory nor executive functions: a consecutive series of 62 patients. Ann Neurol. 1999 Aug;46(2):217-23.

ReferenceCitation: Benabid AL, Koudsie A, Benazzouz A, Vercueil L, Fraix V, Chabardes S, Lebas JF, Pollak P. Deep brain stimulation of the corpus luysi (subthalamic nucleus) and other targets in Parkinson's disease. Extension to new indications such as dystonia and epilepsy. J Neurol. 2001 Sep;248 Suppl 3:III37-47. Review.

ReferenceCitation: Benabid AL, Minotti L, Koudsié A, de Saint Martin A, Hirsch E. Antiepileptic effect of high-frequency stimulation of the subthalamic nucleus (corpus luysi) in a case of medically intractable epilepsy caused by focal dysplasia: a 30-month follow-up: technical case report. Neurosurgery. 2002 Jun;50(6):1385-91; discussion 1391-2.

ReferenceCitation: Chabardès S, Kahane P, Minotti L, Koudsie A, Hirsch E, Benabid AL. Deep brain stimulation in epilepsy with particular reference to the subthalamic nucleus. Epileptic Disord. 2002 Dec;4 Suppl 3:S83-93.

ReferenceCitation: Chkhenkeli SA, Chkhenkeli IS. Effects of therapeutic stimulation of nucleus caudatus on epileptic electrical activity of brain in patients with intractable epilepsy. Stereotact Funct Neurosurg. 1997;69(1-4 Pt 2):221-4.

ReferenceCitation: Cooper IS, Amin I, Gilman S. The effect of chronic cerebellar stimulation upon epilepsy in man. Trans Am Neurol Assoc. 1973;98:192-6.

ReferenceCitation: DeLong MR. Primate models of movement disorders of basal ganglia origin. Trends Neurosci. 1990 Jul;13(7):281-5. Review.

ReferenceCitation: Dematteis M, Kahane P, Vercueil L, Depaulis A. MRI evidence for the involvement of basal ganglia in epileptic seizures: an hypothesis. Epileptic Disord. 2003 Sep;5(3):161-4.

lead_sponsor: University Hospital, Grenoble

location_facility:
University Hospital of Rennes
University Hospital of Strasbourg
University Hospital of Grenoble


title: Effect of N-3 Polyunsaturated Fatty Acids Supplementation on the Human Milk Composition of Lactating Women: Nutritional Intervention With Rapeseed Oil and n-3 Margarine Compared to Standard Olive Oil

acronym: Oméga 3

summary: We propose to measure the LCPUFA human milk (linolenic acid, linoleic acid, docosahexaenoic acid, arachidonic acid) according to fatty acids nature and quantities consumed by lactating women

ReferenceCitation: Lauritzen L, Hansen HS, Jørgensen MH, Michaelsen KF. The essentiality of long chain n-3 fatty acids in relation to development and function of the brain and retina. Prog Lipid Res. 2001 Jan-Mar;40(1-2):1-94. Review.

ReferenceCitation: Sauerwald TU, Hachey DL, Jensen CL, Chen H, Anderson RE, Heird WC. Intermediates in endogenous synthesis of C22:6 omega 3 and C20:4 omega 6 by term and preterm infants. Pediatr Res. 1997 Feb;41(2):183-7.

ReferenceCitation: Cunnane SC, Francescutti V, Brenna JT, Crawford MA. Breast-fed infants achieve a higher rate of brain and whole body docosahexaenoate accumulation than formula-fed infants not consuming dietary docosahexaenoate. Lipids. 2000 Jan;35(1):105-11. Review.

ReferenceCitation: Innis SM, Gilley J, Werker J. Are human milk long-chain polyunsaturated fatty acids related to visual and neural development in breast-fed term infants? J Pediatr. 2001 Oct;139(4):532-8.

ReferenceCitation: Jørgensen MH, Hernell O, Hughes E, Michaelsen KF. Is there a relation between docosahexaenoic acid concentration in mothers' milk and visual development in term infants? J Pediatr Gastroenterol Nutr. 2001 Mar;32(3):293-6.

ReferenceCitation: Simmer K, Patole SK, Rao SC. Long-chain polyunsaturated fatty acid supplementation in infants born at term. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD000376. doi: 10.1002/14651858.CD000376.pub2. Review. Update in: Cochrane Database Syst Rev. 2011;(12):CD000376.

ReferenceCitation: Uauy R, Hoffman DR, Mena P, Llanos A, Birch EE. Term infant studies of DHA and ARA supplementation on neurodevelopment: results of randomized controlled trials. J Pediatr. 2003 Oct;143(4 Suppl):S17-25. Review.

ReferenceCitation: Hoffman DR, Birch EE, Castañeda YS, Fawcett SL, Wheaton DH, Birch DG, Uauy R. Visual function in breast-fed term infants weaned to formula with or without long-chain polyunsaturates at 4 to 6 months: a randomized clinical trial. J Pediatr. 2003 Jun;142(6):669-77.

ReferenceCitation: SanGiovanni JP, Berkey CS, Dwyer JT, Colditz GA. Dietary essential fatty acids, long-chain polyunsaturated fatty acids, and visual resolution acuity in healthy fullterm infants: a systematic review. Early Hum Dev. 2000 Mar;57(3):165-88. Review.

ReferenceCitation: Innis SM, Adamkin DH, Hall RT, Kalhan SC, Lair C, Lim M, Stevens DC, Twist PF, Diersen-Schade DA, Harris CL, Merkel KL, Hansen JW. Docosahexaenoic acid and arachidonic acid enhance growth with no adverse effects in preterm infants fed formula. J Pediatr. 2002 May;140(5):547-54.

ReferenceCitation: Jensen CL, Voigt RG, Prager TC, Zou YL, Fraley JK, Rozelle JC, Turcich MR, Llorente AM, Anderson RE, Heird WC. Effects of maternal docosahexaenoic acid intake on visual function and neurodevelopment in breastfed term infants. Am J Clin Nutr. 2005 Jul;82(1):125-32.

ReferenceCitation: Helland IB, Smith L, Saarem K, Saugstad OD, Drevon CA. Maternal supplementation with very-long-chain n-3 fatty acids during pregnancy and lactation augments children's IQ at 4 years of age. Pediatrics. 2003 Jan;111(1):e39-44.

ReferenceCitation: Fidler N, Sauerwald T, Pohl A, Demmelmair H, Koletzko B. Docosahexaenoic acid transfer into human milk after dietary supplementation: a randomized clinical trial. J Lipid Res. 2000 Sep;41(9):1376-83.

ReferenceCitation: Birch EE, Garfield S, Hoffman DR, Uauy R, Birch DG. A randomized controlled trial of early dietary supply of long-chain polyunsaturated fatty acids and mental development in term infants. Dev Med Child Neurol. 2000 Mar;42(3):174-81.

ReferenceCitation: Innis SM. Human milk: maternal dietary lipids and infant development. Proc Nutr Soc. 2007 Aug;66(3):397-404. Review.

ReferenceCitation: Koletzko B, Lien E, Agostoni C, Böhles H, Campoy C, Cetin I, Decsi T, Dudenhausen JW, Dupont C, Forsyth S, Hoesli I, Holzgreve W, Lapillonne A, Putet G, Secher NJ, Symonds M, Szajewska H, Willatts P, Uauy R; World Association of Perinatal Medicine Dietary Guidelines Working Group. The roles of long-chain polyunsaturated fatty acids in pregnancy, lactation and infancy: review of current knowledge and consensus recommendations. J Perinat Med. 2008;36(1):5-14. doi: 10.1515/JPM.2008.001.

ReferenceCitation: Yuhas R, Pramuk K, Lien EL. Human milk fatty acid composition from nine countries varies most in DHA. Lipids. 2006 Sep;41(9):851-8.

ReferenceCitation: Gibson RA, Neumann MA, Makrides M. Effect of increasing breast milk docosahexaenoic acid on plasma and erythrocyte phospholipid fatty acids and neural indices of exclusively breast fed infants. Eur J Clin Nutr. 1997 Sep;51(9):578-84.

ReferenceCitation: Billeaud C, Bouglé D, Sarda P, Combe N, Mazette S, Babin F, Entressangles B, Descomps B, Nouvelot A, Mendy F. Effects of preterm infant formula supplementation with alpha-linolenic acid with a linoleate/alpha-linolenate ratio of 6: a multicentric study. Eur J Clin Nutr. 1997 Aug;51(8):520-6.

ReferenceCitation: Francois CA, Connor SL, Wander RC, Connor WE. Acute effects of dietary fatty acids on the fatty acids of human milk. Am J Clin Nutr. 1998 Feb;67(2):301-8.

ReferenceCitation: Moltó-Puigmartí C, Castellote AI, Carbonell-Estrany X, López-Sabater MC. Differences in fat content and fatty acid proportions among colostrum, transitional, and mature milk from women delivering very preterm, preterm, and term infants. Clin Nutr. 2011 Feb;30(1):116-23. doi: 10.1016/j.clnu.2010.07.013. Epub 2010 Aug 25.

location_facility: Lactarium Institut de Puériculture de Paris et de Périnatalogie

location_facility: Lactarium CHU La Croix Rousse Lyon Néonatologie et Réanimation Néonatale

location_facility: Lactarium Hôpital Pellegrin Enfants CHU Bordeaux


title: Comparison Between Manual Versus Closed-loop Titration of Propofol and Remifentanil Guided by the qCon and qNox Indexes During Induction and Maintenance of General Anesthesia in Adult Patients: a Multicentre Randomized Controlled Study

acronym: Conox-loop

summary: This study compares automated administration of propofol and remifentanil versus manual administration during general anesthesia for a surgery. The closed-loop coadministration of propofol and remifentanil is guided by qCon and qNox indexes from the Conox monitor.

ReferenceType: result

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.

ReferenceCitation: Jensen EW, Valencia JF, López A, Anglada T, Agustí M, Ramos Y, Serra R, Jospin M, Pineda P, Gambus P. Monitoring hypnotic effect and nociception with two EEG-derived indices, qCON and qNOX, during general anaesthesia. Acta Anaesthesiol Scand. 2014 Sep;58(8):933-41. doi: 10.1111/aas.12359. Epub 2014 Jul 4.

lead_sponsor: CMC Ambroise Paré

location_facility: Service d'Anesthésie Réanimation Chirurgicale, CHU Besançon


title: Avoiding Anticoagulation After IntraCerebral Haemorrhage

summary:
Randomised controlled trials (RCTs) demonstrate a substantial benefit from oral anticoagulant drugs for the prevention of stroke and systemic embolism in non-valvular atrial fibrillation (AF). However, these RCTs excluded patients with prior intracerebral haemorrhage (ICH). Therefore, guidelines are unable to recommend whether oral anticoagulant drugs, in particular non-vitamin K antagonist (called direct OAC) - can be used for patients with AF after an intracerebral haemorrhage.

Roughly 30% of adults with ICH have AF but in 2017 it remains unclear whether they should start oral anticoagulant drugs, be treated with left atrial appendage closure (LAAC) or avoid anticoagulation and LAAC.

ReferenceCitation: Li L, Poon MTC, Samarasekera NE, Perry LA, Moullaali TJ, Rodrigues MA, Loan JJM, Stephen J, Lerpiniere C, Tuna MA, Gutnikov SA, Kuker W, Silver LE, Al-Shahi Salman R, Rothwell PM. Risks of recurrent stroke and all serious vascular events after spontaneous intracerebral haemorrhage: pooled analyses of two population-based studies. Lancet Neurol. 2021 Jun;20(6):437-447. doi: 10.1016/S1474-4422(21)00075-2. Erratum in: Lancet Neurol. 2021 Jun 9;:.

ipd_sharing_description: Prof Cordonnier (chief investigator of A3ICH) is a member of the international Collaboration Of Controlled Randomised trials of Oral Antithrombotic drugs after intraCranial Haemorrhage (COCROACH - coordination Prof Rustam Al-Shahi Salman, UK) working towards a pre-planned individual patient data meta-analysis

location_facility:
GHICL
Hôpital Roger Salengro, CHU
CH De Tourcoing


title: Description of the Use of fidAxomicin in Hospitalized Patients With Documented Clostridium diFficile iNfection and of the managEment of These Patients (DAFNE Study)

acronym: DAFNE

summary: The study aims to describe the characteristics and the methods of management and follow-up of patients treated with fidaxomicin for Clostridium difficile infection (CDI).

ReferenceCitation: Guery B, Berger P, Gauzit R, Gourdon M, Barbut F; DAFNE study group, Dafne Study Group, Bémer P, Bessède E, Camou F, Cattoir V, Couzigou C, Descamps D, Dinh A, Laurans C, Lavigne JP, Lechiche C, Leflon-Guibout V, Le Monnier A, Levast M, Mootien JY, N'Guyen Y, Piroth L, Prazuck T, Rogeaux O, Roux AL, Vachée A, Vernet Garnier V, Wallet F. A prospective, observational study of fidaxomicin use for Clostridioides difficile infection in France. J Int Med Res. 2021 Jun;49(6):3000605211021278. doi: 10.1177/03000605211021278.

lead_sponsor: Astellas Pharma S.A.S.


title: Study of the Efficacy and the Safety of First Line Treatment With CHOP Plus Rituximab (R-CHOP) in Patients Aged 60 to 80 Years With Previously Untreated T-cell Angioimmunoblastic Lymphoma (AIL).

summary: To evaluate the efficacy and the safety of a front-line treatment combining CHOP regimen and rituximab in patients aged 60 to 80 years with previously untreated AIL.

ReferenceCitation: Attygalle A, Al-Jehani R, Diss TC, Munson P, Liu H, Du MQ, Isaacson PG, Dogan A. Neoplastic T cells in angioimmunoblastic T-cell lymphoma express CD10. Blood. 2002 Jan 15;99(2):627-33.

ReferenceCitation: Lome-Maldonado C, Canioni D, Hermine O, Delabesse E, Damotte D, Raffoux E, Gaulard P, Macintyre E, Brousse N; French Groupe d'Etude des Lymphomes de l'Adulte (GELA). Angio-immunoblastic T cell lymphoma (AILD-TL) rich in large B cells and associated with Epstein-Barr virus infection. A different subtype of AILD-TL? Leukemia. 2002 Oct;16(10):2134-41.

ReferenceCitation: Zettl A, Lee SS, Rüdiger T, Starostik P, Marino M, Kirchner T, Ott M, Müller-Hermelink HK, Ott G. Epstein-Barr virus-associated B-cell lymphoproliferative disorders in angloimmunoblastic T-cell lymphoma and peripheral T-cell lymphoma, unspecified. Am J Clin Pathol. 2002 Mar;117(3):368-79.

ReferenceCitation: Gisselbrecht C, Gaulard P, Lepage E, Coiffier B, Brière J, Haioun C, Cazals-Hatem D, Bosly A, Xerri L, Tilly H, Berger F, Bouhabdallah R, Diebold J. Prognostic significance of T-cell phenotype in aggressive non-Hodgkin's lymphomas. Groupe d'Etudes des Lymphomes de l'Adulte (GELA). Blood. 1998 Jul 1;92(1):76-82.

lead_sponsor: Lymphoma Study Association

location_facility: Service d'Hématologie - Centre Hospitalier Lyon-Sud


title: A 96-Week, Prospective, Multicenter, Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare Efficacy and Safety of Masitinib Dose Titration to 4.5 mg/kg/Day Versus Placebo in the Treatment of Patients With Primary Progressive or Secondary Progressive Multiple Sclerosis Without Relapse

summary: To evaluate the efficacy and safety of oral masitinib versus placebo in the treatment of patients with primary progressive or secondary progressive multiple sclerosis without relapse.

ReferenceCitation: Vermersch P, Brieva-Ruiz L, Fox RJ, Paul F, Ramio-Torrenta L, Schwab M, Moussy A, Mansfield C, Hermine O, Maciejowski M; AB07002 Study Group. Efficacy and Safety of Masitinib in Progressive Forms of Multiple Sclerosis: A Randomized, Phase 3, Clinical Trial. Neurol Neuroimmunol Neuroinflamm. 2022 Feb 21;9(3). pii: e1148. doi: 10.1212/NXI.0000000000001148. Print 2022 May.

ReferenceCitation: Vermersch P, Benrabah R, Schmidt N, Zéphir H, Clavelou P, Vongsouthi C, Dubreuil P, Moussy A, Hermine O. Masitinib treatment in patients with progressive multiple sclerosis: a randomized pilot study. BMC Neurol. 2012 Jun 12;12:36. doi: 10.1186/1471-2377-12-36.

ReferenceCitation: Latham BD, Oskin DS, Crouch RD, Vergne MJ, Jackson KD. Cytochromes P450 2C8 and 3A Catalyze the Metabolic Activation of the Tyrosine Kinase Inhibitor Masitinib. Chem Res Toxicol. 2022 Sep 19;35(9):1467-1481. doi: 10.1021/acs.chemrestox.2c00057. Epub 2022 Sep 1.

lead_sponsor: AB Science

location_facility: Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg

location_facility: Centre Hospitalier Universitaire de Strasbourg


title: A Phase I Study to Evaluate the Safety and Determine the Maximum Tolerated Dose (MTD) of Debio 1143 Combined With Carboplatin and Paclitaxel in Patients With Squamous Non-Small Cell Lung Cancer (NSCLC), Platinum-refractory Ovarian Cancer, and Basal-like/Claudin Low Triple Negative Breast Cancer (TNBC)

summary:
This is a two-part trial in patients with squamous non-small cell lung cancer (NSCLC), platinum (Pt)-refractory ovarian cancer, and basal-like/claudin low triple negative breast cancer (TNBC).

The primary objective of Part A is to determine the maximum tolerated dose (MTD) of Debio 1143 when administered to these patients in combination with full doses of paclitaxel and carboplatin.

The primary objective of Part B is to consolidate the safety profile of the recommended dose of Debio 1143 when administered to these patients in combination with full doses of paclitaxel and carboplatin.

lead_sponsor: Debiopharm International SA

location_facility:
Centre Léon Bérard
Institut Claudius Regaud
Institut Curie
Centre Georges François Leclerc


title: Treatment of Major Depression by Magnetic Stimulation Repeated Transcranial on Prefrontal Cortex: Study of Underlying Mechanisms

acronym: DEPSTIM

summary: The study aims to evaluate the impact of repeated Transcranial Magnetic Stimulation (rTMS) on underlying neuronal mechanisms of adults suffering from major depression disorder (MDD). Short- and long-term effects are assessed by High-Resolution electroencephalography (HR-EEG) or Magnetic Resonance Imaging (MRI) records, experimental tasks and self-rated scales.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Autism Spectrum Disorders: Double Blind Randomized Placebo-control Active Pilot Study of Transcranial Magnetic Stimulation Applied to the Superior Temporal Sulcus

acronym: STIMAUT

summary: Difficulties in social interactions are the core feature of autism spectrum disorder (ASD) and are characterized by abnormal social perception, mainly concerning eye gaze. Anatomo-functional abnormalities within the superior temporal sulcus (STS), a key region of the social brain, have been described in ASD. The investigators had recently shown that it is possible to modulate the neural activity of the STS with transcranial magnetic stimulation (TMS) with an impact on social perception, measured by eye-tracking. In the context of ASD, stimulation of the STS with excitatory TMS could lead to an improvement in social perception, which would open up new therapeutic strategies. The purpose of this double-blind, randomized, placebo-controlled study is to apply a therapeutic TMS protocol (10 daily sessions) at the right STS in young adults with ASD to improve their social behavior, objectively measured using eye-tracking.

location_facility: Hôpital Necker Enfants Malades - Service de radiologie pédiatrique


title: Pain of Patients, Suffering of Caregivers: Evaluation of the Benefit of Full Consciousness Meditation in Oncology to Improve Stress and Quality of Life With Joint Participation of "Witness / Patient / Caregivers"

acronym: IMPLIC

summary: The study is based on the realization of a meditation program associating patients, caregivers and control subjects

ReferenceCitation: Prevost V, Lefevre-Arbogast S, Leconte A, Delorme C, Benoit S, Tran T, Clarisse B. Shared meditation involving cancer patients, health professionals and third persons is relevant and improves well-being: IMPLIC pilot study. BMC Complement Med Ther. 2022 May 18;22(1):138. doi: 10.1186/s12906-022-03599-w.

ReferenceCitation: Prevost V, Clarisse B, Leconte A, Delorme C, Benoit S, Tran T. Meditation involving people with cancer, medical staff and witnesses: a pilot study exploring improvement in wellness and connectedness. BMJ Open. 2021 Nov 12;11(11):e048164. doi: 10.1136/bmjopen-2020-048164.

lead_sponsor: Centre Francois Baclesse


acronym: ACABII

summary:
Cerebrovascular accident (CVA) constitutes a major health public problem. This represents the second cardiovascular death cause. CVA is ischemic in 80% of cases. Atheroma of large arteries, mainly carotid, is involved in about 20% of cases.

After several high grade studies (NASCET, ECST, ACAS, ACST), carotid surgery is based on stenosis calculation by Doppler ultrasound, CT angiography, MRI angiography or arteriography.

The composition of the plaque, showing its vulnerability, is associated with embolic risk and stroke. The therapeutic strategy based only on the narrowing of the arterial lumen is not satisfactory enough to prevent the occurrence of a transient ischemic attack (TIA) or an ipsilateral stroke due to carotid stenosis. Thus, new techniques emerge, to evaluate in vivo the inflammation of the plaque, its embolic consequences or the mechanical stress it undergoes. These techniques are: High Resolution MRI (HR MRI), evaluation of the Gray Scale Median (GSM) level, study of the plaque vascularization with Contrast Enhanced ultrasound (CEUS), High Intensity Transient Signals (HITS) by transcranial Doppler, micro RNA profile (mi RNA). These different modalities must be combined in order to increase the efficiency.

Based on these encouraging results, the investigator aim at evaluating the ability of different methods or their combination to predict the occurrence of ischemic stroke or TIA due to emboli from a carotid atherosclerotic plaque. Before considering a cohort study, he investigator want to evaluate the performance of each of these new methods in the characterization of carotid plaque instability. Performance evaluation will allow us to choose secondarily the most relevant association.

The investigator propose, as a first step, to make a case-control study with these methods, the cases are patients who had an ischemic stroke (authenticated by both the clinical exam and brain MRI) on the same side as the carotid stenosis and the controls are patients with carotid stenosis but without ischemic stroke. This study is a cross-sectional study because it simultaneously measures the occurrence of the event (ischemic stroke) and the characteristics of the atheromatous plaque.

Over a 2 year period, 45 symptomatic patients and 105 asymptomatic patients will be included with a carotid stenosis with at least a 50% caliber constriction according to NASCET criteria. (North American Symptomatic Carotid Endarterectomy Trial).

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Service de radiologie


title: Benefits of the Involvement of Nurses in Meetings Between Physicians and the Families of Patients in the ICU.

acronym: NEWS

summary:
When a patient is admitted to the ICU this often happens so suddenly that this can create a significant amount of stress and anxiety for family members for several reasons. Firstly, the family does not have a pre existing relationship with the ICU team. Secondly, the urgency of the situation and the technic it requires is often such that minimal information can be given to family members. And finally, as a result of the unpredictability of each patient's condition, it can be difficult to predict outcome for family members. Together, these factors compound the stress and anxiety of family members. This anxiety is natural and it is important for health caregivers to be able to offer the best support possible. A high quality communication provided by structured information given by physicians and nurses as well could improve support to the families and lead to greater satisfaction.

Giving information to families during meetings is crucial at 3 moments: at the first day when the patient is admitted, at day 3, weekly and each time important news is given (surgery, deterioration in condition, end-of-life).

The purpose of this project is to evaluate if the involvement of nurses during those meetings could improve quality in communication which is assessed by mixed methods. Families and healthcare workers satisfaction will be assessed by qualitative methodology. Family peritraumatic stress, symptoms of anxiety and depression and PTSD will be assessed using validated scales.

Training of healthcare workers will be done by role play. Information to the families is delivered using a framework for physicians and nurses. All the meetings of the study will be audited by a psychologist.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

location_facility: Groupe Hospitalier Paris Saint Joseph - Service de Réanimation Polyvalente


title: Prognostic Value of Human Papillomavirus (HPV) Detection in Cervical Intra-epithelial Neoplasia (CIN) Recurrence After Conization: Prospective Study With Virological Follow-up on 24 Months (SUIVICOL)

acronym: SUIVICOL

summary: CIN2/3 have been increased for many years and mainly concern women aged 25-29 years. They are subsequent to a persistent HPV infection and are classically treated by conization. Recurrences occur in 7 to 18 % of cases, mainly after CIN3 management during the first 2 years of follow-up. Follow-up is crucial to detect and treat recurrence and to select high risk women who might develop cervical cancer. Colposcopy and cytology have been recommended since 1989 by French ANAES, but these methods have poor sensitivity and specificity. However, DNA HPV testing is more sensitive and has demonstrated a very high negative predictive value, while specificity and positive predictive value remain average. Other HPV markers like genotyping, viral load and integration begin to be used in screening but have not been investigated in CIN2/3 follow-up to assess the values of various HPV markers which predict CIN2/3 recurrence after conization. The primary objective is to describe HPV expression (genotyping, viral load, mRNA E6 and E7) at the time of conization and during the follow-up period (6, 12, 24 months) and to assess the prognostic value of HPV 16 expression (viral load, mRNA E6 and E7) to determine the risk of CIN2/3 recurrence after conization, compared to the other clinical and virological risk factors.

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Toulouse, Hôpital Paule de Viguier


title: The "BCB-sarcomes" Database: the Database of the French Sarcoma Group Dedicated to the Collection of Clinical and Biological Data for All Sarcomas

acronym: BCB-Sarcomes

summary:
The BCB SARCOMES database is a clinical and biological national database dedicated to sarcoma that contains 3 main databases with specific aims: the first is the pathology database (French expert network dedicated to the management of bone sarcomas [RESOS] / French expert network dedicated to the pathology of sarcomas [RREPS]), dedicated to systematic review of mesenchymal tumor diagnostics nationwide; the second is clinical (RESOS / French expert clinical network for sarcomas [NETSARC]), collecting multidisciplinary tumor boards (MDTB) data of patients nationwide, and the third (CONTICABASE / BONE / GIST) is dedicated to collecting patients longitudinal/follow up data, with a focus on treatments of every events, and a catalogue of associated samples.

Primary objectives of BCB-SARCOMES are the following: description of the patterns of care and treatment outcomes, assessment of the prognostic factors of patients' outcomes.

With the financial support of the French National Cancer Institute [Institut National du cancer [INCa]).

ReferenceCitation: Savina M, Le Cesne A, Blay JY, Ray-Coquard I, Mir O, Toulmonde M, Cousin S, Terrier P, Ranchere-Vince D, Meeus P, Stoeckle E, Honoré C, Sargos P, Sunyach MP, Le Péchoux C, Giraud A, Bellera C, Le Loarer F, Italiano A. Patterns of care and outcomes of patients with METAstatic soft tissue SARComa in a real-life setting: the METASARC observational study. BMC Med. 2017 Apr 10;15(1):78. doi: 10.1186/s12916-017-0831-7.

ReferenceCitation: Toulmonde M, Bonvalot S, Méeus P, Stoeckle E, Riou O, Isambert N, Bompas E, Jafari M, Delcambre-Lair C, Saada E, Le Cesne A, Le Péchoux C, Blay JY, Piperno-Neumann S, Chevreau C, Bay JO, Brouste V, Terrier P, Ranchère-Vince D, Neuville A, Italiano A; French Sarcoma Group. Retroperitoneal sarcomas: patterns of care at diagnosis, prognostic factors and focus on main histological subtypes: a multicenter analysis of the French Sarcoma Group. Ann Oncol. 2014 Mar;25(3):735-742. doi: 10.1093/annonc/mdt577.

ReferenceCitation: Blay JY, Soibinet P, Penel N, Bompas E, Duffaud F, Stoeckle E, Mir O, Adam J, Chevreau C, Bonvalot S, Rios M, Kerbrat P, Cupissol D, Anract P, Gouin F, Kurtz JE, Lebbe C, Isambert N, Bertucci F, Toumonde M, Thyss A, Piperno-Neumann S, Dubray-Longeras P, Meeus P, Ducimetière F, Giraud A, Coindre JM, Ray-Coquard I, Italiano A, Le Cesne A. Improved survival using specialized multidisciplinary board in sarcoma patients. Ann Oncol. 2017 Nov 1;28(11):2852-2859. doi: 10.1093/annonc/mdx484.

lead_sponsor: Institut Bergonié

location_facility: Institut Bergonié, Comprehensive Cancer Center

location_facility: Institut Gustave Roussy, Comprehensive Cancer Center

intervention_type: Radiation


acronym: REMOMEPO

title: Airway Remodeling Changes Induced by Mepolizumab in Severe Eosinophil Asthma

summary: Chronic airway changes, such as smooth muscle hypertrophy/hyperplasia, reticular basement membrane (RBM) thickening, goblet cells hyperplasia characterize severe asthma. Chronic inflammation, and especially eosinophilia and T2 cytokines are involved in these structural changes. The aim of this prospective observational study is to assess airway changes, assessed by bronchial biopsies before treatment, then after 6 months and 12 months, induced by mepolizumab in 40 severe asthma patients who will receive the treatment as part of their standard care. Changes in RBM thickening, in airway smooth muscle (ASM) area, in the number of PGP9 sections will be assessed on bronchial biopsies after 6 months and 12 months of mepolizumab treatment. Bronchoalveolar lavage (BAL) levels of inflammatory and remodeling mediators and of extra-cellular matrix (ECM) components will be measured after 6 months and 12 months of mepolizumab treatment. Relationship between clinical response to mepolizumab and remodeling changes after 6 months and 12 months will be assessed.


title: Preliminary Study of the Quality of the Oral Flora in Parkinson's Patients

acronym: PARKIDENT

summary: This is a prospective interventional clinical study whose main objective is to determine the impact of oral hygiene guidance on the oral health status of patients with Parkinson disease


title: Stimuli Sociaux et Non-sociaux du système de récompense : Une étude en IRM Chez Des Sujets Avec Trouble du Spectre de l'Autisme et Des Sujets Avec un Trouble Addictif à l'Alimentation. - RESYSTAA

acronym: RESYSTAA

summary: An MRI Study in Subjects with Autism Spectrum Disorder and Subjects with Food Addictive Disorder compared to healthy volunteers.

lead_sponsor: University Hospital, Tours

location_facility: University Addictology Service, Liaison Team and Addictology Care

location_facility: University Hospital, Medical Imaging Service

location_facility: Center-Val de Loire Region Autism Resource Center


acronym: OREX

title: Severe Decrease of Growth Velocity in Children With Anorexia Nervosa. Therapeutic Trial of Growth Hormone

ReferenceCitation: Léger J, Fjellestad-Paulsen A, Bargiacchi A, Pages J, Chevenne D, Alison M, Alberti C, Guilmin-Crepon S. One Year of GH Treatment for Growth Failure in Children With Anorexia Nervosa: A Randomized Placebo-Controlled Trial. J Clin Endocrinol Metab. 2021 Jun 16;106(7):e2535-e2546. doi: 10.1210/clinem/dgab203.

summary: Anorexia nervosa may be responsible for a catch- down or even an interruption of growth, delayed puberty and osteopenia with failure of acquisition of bone mass. The recovery of normal nutrition usually leads to a resumption of growth and pubertal development. However, despite a therapeutic nutritional and psychotherapeutic satisfactory approach, some patients have a significant short stature with reduced adult final height and a deficit of bone mass. The main objective is to evaluate the effect of growth hormone (hGH) treatment on the growth velocity in prepubertal children or children in early puberty with anorexia nervosa and significant reduction of height velocity. This is a single-center, controlled, randomized and double-blind clinical trial evaluating the efficacy of hGH treatment for 1 year against a placebo, on the growth velocity of prepubertal or children in early puberty with Anorexia nervosa and major catch-down.This period is followed by the evaluation of the hGH treatment in children receiving placebo and continued hGH treatment in the treatment arm for 1 year, in total 2 years of study for each child. This second period corresponds to an ethical consideration giving secondarily access to treatment for patients in the placebo group.


title: A Comparison of Symbicort Single Inhaler and Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents and Adults - a 26-week, Randomised, Open, Parallel Group Multicentre Study

summary: The purpose of the study is to compare the efficacy of a flexible dose of Symbicort with conventional stepwise treatment according to asthma treatment guidelines in patients with persistent asthma.

lead_sponsor: AstraZeneca

location_facility:
Research Sites
Research site
Research Site


title: Systemic Inflammation and Obstructive Sleep Apnea Syndrome: Effect of Atorvastatin

acronym: StatinflaSAS

summary:
The aim of this clinical trial is to evaluate the effect of Atorvastatin on the endothelial function improvement during the obstructive sleep apnea syndrome (OSAS) after 3 months of treatment, by a double-blind, randomized, placebo-controlled, multi-center study.

An interim analysis will be performed when 25 patients per group will be included.

ReferenceCitation: Bergeron C, Kimoff J, Hamid Q. Obstructive sleep apnea syndrome and inflammation. J Allergy Clin Immunol. 2005 Dec;116(6):1393-6.

ReferenceCitation: Jullian-Desayes I, Tamisier R, Zarski JP, Aron-Wisnewsky J, Launois-Rollinat SH, Trocme C, Levy P, Joyeux-Faure M, Pepin JL. Impact of effective versus sham continuous positive airway pressure on liver injury in obstructive sleep apnoea: Data from randomized trials. Respirology. 2016 Feb;21(2):378-85. doi: 10.1111/resp.12672. Epub 2015 Nov 16.

ReferenceCitation: Joyeux-Faure M, Tamisier R, Baguet JP, Dias-Domingos S, Perrig S, Leftheriotis G, Janssens JP, Trzepizur W, Launois SH, Stanke-Labesque F, Lévy PA, Gagnadoux F, Pepin JL. Response to statin therapy in obstructive sleep apnea syndrome: a multicenter randomized controlled trial. Mediators Inflamm. 2014;2014:423120. doi: 10.1155/2014/423120. Epub 2014 Aug 25.

location_country: France Switzerland

location_facility:
Universitary Hospital of Angers
Hospital of Annemasse
University Hospital of Grenoble
Universitary Hospital of Geneva


title: An Open, Phase II Trial Assessing the Objective Response Rate After Combination of Arimidex® 1mg Per os/Day and Zoladex® 3.6 mg Sub Cut/Monthly as 1st Treatment for Premenopausal Receptor Positive Advanced or Metastatic Breast Cancer

summary: The purpose of this study is to determine the efficacy and tolerance of the association of two drugs already marketed and used to treat your disease: Arimidex® 1 Mg per day per os and Zoladex® 3,6 Mg in injections under cutaneous once per month in subjects with breast cancer.


title: Characterization of the Effect of Tocilizumab in Vivo and in Vitro on T Follicular Helper Cells in Rheumatoid Arthritis Patients and Consequence on B Cells Maturation

acronym: Tocihelper

summary:
Naïve CD4+ helper T (Th) cells, upon encountering their cognate antigens presented on professional antigen-presenting cells, differentiate into different effector cells:

Th1 cells produce Interferon-γ and regulate antigen presentation and immunity against intracellular pathogens;
Th2 cells produce IL-4 (Interleukin-4), IL-5 and IL-13, and mediate humoral responses and immunity against parasites;
Th17 cells produce IL-17, IL-17F and IL-22 and regulate inflammatory responses by tissue cells.

An additional TH subset called follicular helper T (Tfh) cells has recently been identified in germinal centers and also in whole blood (circulating Tfh cells). These cells regulate B-cell maturation and immunoglobulin production during normal immune responses. They produce factors essential for B cell selection and maturation into memory B-cells or long-lived antibody-secreting plasma cells. Furthermore, they also seem to favor pathogenic autoantibody production in systemic autoimmunity, and therefore could potentially represent a novel therapeutic target in autoimmune diseases. Indeed, rheumatoid arthritis synovium is characterized by the presence of ectopic lymphoid structures, resembling germinal centers. Potentially, Tfh cells from these nonlymphoid tissues could promote B-cell maturation and synthesis of pathogenic autoantibody production, thus potentiating tissue injury. Interestingly, production of IL-21 by Tfh cells is implicated in B cell activation, and the same cytokine have been associated with rheumatoid arthritis (RA) pathogenesis.

IL-6 blocking therapy significantly reduces signs and symptoms as well as radiological progression in RA. However, so far, it has not been determined which of the pleiotropic IL-6 effects impact the observed clinical response. Recently, Samson et al have demonstrated that Tocilizumab (TCZ) corrects the imbalance between Th17 cells and Treg cells in patients with RA. More interestingly, the group of Hans-Peter Tony has reported the impact of TCZ on B cell compartment. They showed a significant reduction in the frequency of peripheral pre-switch and post-switch memory B cells but also a reduction of serum immunoglobulin levels, that could be the reflect of TCZ on Tfh cells development, circulation and/or function.

Most of the work studying the role of IL-6 on Tfh cells development has been performed in mice. They showed that optimal Tfh cells formation requires IL-21 and IL-6, and that cytokines alone are insufficient to drive Tfh cells differentiation.

To better understand the impact of IL-6 on human Tfh cells, the investigators would like to conduct a prospective study in patients with active RA and investigated the effects of blocking IL-6 with TCZ on circulating Tfh cells levels and Tfh cells subsets over a 12-week study period. Furthermore, the impact of TCZ treatment on Tfh cells generation will be explored in vitro.

lead_sponsor: Association Aquitaine de Recherche Clinique en Rhumatologie

location_facility: Rheumatology department - Bordeaux University Hospital


title: Modulation of Lactase Expression by a New Synthetic PPARgamma Ligand in Ex-vivo Cultures of Duodenal Biopsies

summary: This study is designed to assess the effect of a new PPARgamma modulator on the expression and activity of the lactase enzyme in human intestinal epithelial cells. Based on their previous experimental results, the investigators hypothesized that modulating intestinal PPARgamma activity is a new pharmacological mechanism allowing the control of lactase expression and activity in the gut

lead_sponsor: University Hospital, Lille


title: Effects Rehabilitation Programme in Adapted Physical Activity (APA) Among Type 2 Diabetics Persons

summary: The principal objective is to assess and analyze the effects of a six month programme in Adapted Physical Activity (APA) on physical activity, compliance, and insulin resistance among type 2 diabetics.

ReferenceCitation: Bouvard S, Faure P, Roucard C, Favier A, Halimi S. Characterization of free radical defense system in high glucose cultured HeLa-tat cells: consequences for glucose-induced cytotoxicity. Free Radic Res. 2002 Sep;36(9):1017-22.

ReferenceCitation: Halimi S, Wion-Barbot N, Lambert S, Benhamou P. [Self-monitoring of blood glucose in type 2 diabetic patients. What could we propose according to their treatment?]. Diabetes Metab. 2003 Apr;29(2 Pt 2):S26-30. Review. French.

ReferenceCitation: Halimi S. [Therapeutic strategies for type 2 diabetes]. Rev Prat. 2003 May 15;53(10):1079-85. Review. French.

ReferenceCitation: Halimi S. [Is a new therapeutic class justified in the treatment of type 2 diabetes?]. Ann Endocrinol (Paris). 2002 Apr;63(2 Pt 2):1S7-11. Review. French.

ReferenceCitation: Halimi S, Charpentier G, Grimaldi A, Grenier JL, Baut F, Germain B, Magnette J. Effect on compliance, acceptability of blood glucose self-monitoring and HbA(1c) of a self-monitoring system developed according to patient's wishes. The ACCORD study. Diabetes Metab. 2001 Dec;27(6):681-7.

location_facility: Endocrinology, Diabetology and Nutrition - University Hospital of Grenoble

location_facility: Department of Endocrinology, Diabetology and Nutrition

location_facility: Endocrinology, Diabetology and Nutrition Department - University Hospital of Grenoble


title: Diagnostic Accuracy of Lung MRI to Detect Allergic Broncho-pulmonary Aspergillosis in Cystic Fibrosis

acronym: MRAB

summary: In this diagnostic study, the aim is at evaluating the diagnostic accuracy of MRI (Magnetic Resonance Imaging) to detect allergic broncho-pulmonary aspergillosis in patients with cystic fibrosis.

lead_sponsor: Hôpital Haut Lévêque


title: Multicentric Observational National Analysis of Listeriosis and Listeria : Evaluation of the Neurological Consequences of Perinatal Listeriosis Infection

acronym: MONALISABABY

summary: The purpose of the study is to determine whether perinatal listeriosis is associated with long-term neurological consequences, and to evaluate the respective contribution of perinatal sepsis, of prematurity and of the known neurological tropism of the involved pathogen, Listeria monocytogenes.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: A Phase 2 Study of Velcade™ in Subjects With Relapsed or Refractory Follicular B-Cell Lymphoma

summary:
This is a prospective, randomized, sequential, international, multicentric, 2-arm, non-comparative, open-label, 2-stage clinical study to determine disease response rates to Velcade™ therapy in subjects who have relapsed or refractory follicular B-cell lymphoma.

Qualitative comparisons of the 2 treatment arms based on safety, efficacy and dosing convenience will be made in order to recommend a dose schedule for further clinical study.

ReferenceCitation: O'Connor OA, Wright J, Moskowitz C, Muzzy J, MacGregor-Cortelli B, Stubblefield M, Straus D, Portlock C, Hamlin P, Choi E, Dumetrescu O, Esseltine D, Trehu E, Adams J, Schenkein D, Zelenetz AD. Phase II clinical experience with the novel proteasome inhibitor bortezomib in patients with indolent non-Hodgkin's lymphoma and mantle cell lymphoma. J Clin Oncol. 2005 Feb 1;23(4):676-84. Epub 2004 Dec 21.

ReferenceCitation: Goy A, Younes A, McLaughlin P, Pro B, Romaguera JE, Hagemeister F, Fayad L, Dang NH, Samaniego F, Wang M, Broglio K, Samuels B, Gilles F, Sarris AH, Hart S, Trehu E, Schenkein D, Cabanillas F, Rodriguez AM. Phase II study of proteasome inhibitor bortezomib in relapsed or refractory B-cell non-Hodgkin's lymphoma. J Clin Oncol. 2005 Feb 1;23(4):667-75. Epub 2004 Dec 21.

location_country: France Belgium

location_facility: Groupe d'Etude des Lymphomes de l'adulte

location_facility: Service d'Hématologie - Centre Hospitalier Lyon-Sud


title: Comparison of the Effects Noted in The ApoB/ApoA-I Ratio Using Rosuvastatin and Atorvastatin in Patients With acUte Coronary Syndrome - CENTAURUS

summary: The purpose of this study is to see if rosuvastatin compared to Atorvastatin is effective in treating ACS by decreasing the ApoB/ApoA-1 ratio and if starting statin within 24 h following the onset of the first symptoms is beneficial compared to placebo.

ReferenceCitation: Lablanche JM, Leone A, Merkely B, Morais J, Alonso J, Santini M, Eha J, Demil N, Licour M, Tardif JC; CENTAURUS investigators. Comparison of the efficacy of rosuvastatin versus atorvastatin in reducing apolipoprotein B/apolipoprotein A-1 ratio in patients with acute coronary syndrome: results of the CENTAURUS study. Arch Cardiovasc Dis. 2010 Mar;103(3):160-9. doi: 10.1016/j.acvd.2010.01.005. Epub 2010 Apr 8.

location_country: Portugal Spain Greece Ireland Estonia Italy Canada Tunisia Hungary France Belgium

location_facility:
Research site
Research Site


title: Genetic and Environmental Risk Factors of Type 1 Autoimmune Diabetes and Its Early Complications. French Multicentric Cohort of Diabetic Patients.

acronym: ISIS-DIAB

summary:
The aim of this study is to complete the identification of genetic factors (G) and to undertake the search of environmental factors (E) predisposing to type 1 diabetes (T1D) by constituting a cohort of 3500 T1D patients and a control cohort. We will use the base of G analysis (whole genome genotyping done once a patient using methods conually updated at Centre National de Genotype) and innovative E analysis to develop the following long term objectives :

Identify G and E factors influencing the process of remaining beta cells' destruction during the first 3 years after diagnosis (subgroup of T1D patients with a 0-3 years diabetes duration);
Identify G factors (pharmacogenomics) of the individual response to insulin using the effective insulin dose as a phenotype over a period of 2 years (subgroup of T1D patients with negative C-peptide and well managed diabetes);
Undertake a prospective research of G and E risk factors of "death in bed" syndrome in diabetic adolescents;
Undertake a prospective research of G and E risk factors of incipient glomerular microangiopathy (regule measurement of microalbuminuria).

ReferenceCitation: Balazard F, Le Fur S, Valtat S, Valleron AJ, Bougnères P; Isis-Diab collaborative group, Thevenieau D, Chatel CF, Desailloud R, Bony-Trifunovic H, Ducluzeau PH, Coutant R, Caudrelier S, Pambou A, Dubosclard E, Joubert F, Jan P, Marcoux E, Bertrand AM, Mignot B, Penformis A, Stuckens C, Piquemal R, Barat P, Rigalleau V, Stheneur C, Fournier S, Kerlan V, Metz C, Fargeot-Espaliat A, Reznic Y, Olivier F, Gueorguieva I, Monier A, Radet C, Gajdos V, Terral D, Vervel C, Bendifallah D, Signor CB, Dervaux D, Benmahammed A, Loeuille GA, Popelard F, Guillou A, Benhamou PY, Khoury J, Brossier JP, Bassil J, Clavel S, Le Luyer B, Bougnères P, Labay F, Guemas I, Weill J, Cappoen JP, Nadalon S, Lienhardt-Roussie A, Paoli A, Kerouedan C, Yollin E, Nicolino M, Simonin G, Cohen J, Atlan C, Tamboura A, Dubourg H, Pignol ML, Talon P, Jellimann S, Chaillous L, Baron S, Bortoluzzi MN, Baechler E, Salet R, Zelinsky-Gurung A, Dallavale F, Larger E, Laloi-Michelin M, Gautier JF, Guérin B, Oilleau L, Pantalone L, Lukas C, Guilhem I, De Kerdanet M, Wielickzo MC, Priou-Guesdon M, Richard O, Kurtz F, Laisney N, Ancelle D, Parlier G, Boniface C, Bockel DP, Dufillot D, Razafimahefa B, Gourdy P, Lecomte P, Pepin-Donat M, Combes-Moukhovsky ME, Zymmermann B, Raoulx M, Dumont AG. Association of environmental markers with childhood type 1 diabetes mellitus revealed by a long questionnaire on early life exposures and lifestyle in a case-control study. BMC Public Health. 2016 Sep 29;16(1):1021.