type: Other Identifier

title: Genomic and Proteomic Study of Richter Syndrome

acronym: CGPSR

summary:
Biological study on Richter Syndrome (RS), an agressive lymphoma that arises from Chronic Lymphocytice Leukemia (CLL). RS presents with the same histological aspect as primitive Diffuse Large B-Cell Lymphoma (DLBCL), but is associated with a poor prognosis, due to chemorefractoriness.

This study aims at understanding the biological determinants of chemotherapy resistance in Richter Syndrome.

ReferenceCitation: Rossi D, Spina V, Forconi F, Capello D, Fangazio M, Rasi S, Martini M, Gattei V, Ramponi A, Larocca LM, Bertoni F, Gaidano G. Molecular history of Richter syndrome: origin from a cell already present at the time of chronic lymphocytic leukemia diagnosis. Int J Cancer. 2012 Jun 15;130(12):3006-10. doi: 10.1002/ijc.26322. Epub 2011 Aug 25.

ReferenceCitation: Ferreira PG, Jares P, Rico D, Gómez-López G, Martínez-Trillos A, Villamor N, Ecker S, González-Pérez A, Knowles DG, Monlong J, Johnson R, Quesada V, Djebali S, Papasaikas P, López-Guerra M, Colomer D, Royo C, Cazorla M, Pinyol M, Clot G, Aymerich M, Rozman M, Kulis M, Tamborero D, Gouin A, Blanc J, Gut M, Gut I, Puente XS, Pisano DG, Martin-Subero JI, López-Bigas N, López-Guillermo A, Valencia A, López-Otín C, Campo E, Guigó R. Transcriptome characterization by RNA sequencing identifies a major molecular and clinical subdivision in chronic lymphocytic leukemia. Genome Res. 2014 Feb;24(2):212-26. doi: 10.1101/gr.152132.112. Epub 2013 Nov 21.

ReferenceCitation: Rossi D, Cerri M, Capello D, Deambrogi C, Rossi FM, Zucchetto A, De Paoli L, Cresta S, Rasi S, Spina V, Franceschetti S, Lunghi M, Vendramin C, Bomben R, Ramponi A, Monga G, Conconi A, Magnani C, Gattei V, Gaidano G. Biological and clinical risk factors of chronic lymphocytic leukaemia transformation to Richter syndrome. Br J Haematol. 2008 Jun;142(2):202-15. doi: 10.1111/j.1365-2141.2008.07166.x. Epub 2008 May 19.

family: Rossi

full_name: Davide Rossi

given: Davide

family: Cerri

full_name: Michaela Cerri

given: Michaela

family: Capello

full_name: Daniela Capello

given: Daniela

family: Deambrogi

full_name: Clara Deambrogi

given: Clara

full_name: Francesca Maria Rossi

given: Francesca Maria

family: Zucchetto

full_name: Antonella Zucchetto

given: Antonella

family: De Paoli

full_name: Lorenzo De Paoli

given: Lorenzo

family: Cresta

full_name: Stefania Cresta

given: Stefania

family: Rasi

full_name: Silvia Rasi

given: Silvia

family: Spina

full_name: Valeria Spina

given: Valeria

family: Franceschetti

full_name: Silvia Franceschetti

family: Lunghi

full_name: Monia Lunghi

given: Monia

family: Vendramin

full_name: Chiara Vendramin

given: Chiara

family: Bomben

full_name: Riccardo Bomben

given: Riccardo

family: Ramponi

full_name: Antonio Ramponi

given: Antonio

family: Monga

full_name: Guido Monga

given: Guido

family: Conconi

full_name: Annarita Conconi

given: Annarita

family: Magnani

full_name: Corrado Magnani

given: Corrado

family: Gattei

full_name: Valter Gattei

given: Valter

family: Gaidano

full_name: Gianluca Gaidano

given: Gianluca

journal_name: British Journal of Haematology

ReferenceCitation: Parikh SA, Rabe KG, Call TG, Zent CS, Habermann TM, Ding W, Leis JF, Schwager SM, Hanson CA, Macon WR, Kay NE, Slager SL, Shanafelt TD. Diffuse large B-cell lymphoma (Richter syndrome) in patients with chronic lymphocytic leukaemia (CLL): a cohort study of newly diagnosed patients. Br J Haematol. 2013 Sep;162(6):774-82. doi: 10.1111/bjh.12458. Epub 2013 Jul 11.

name: Division of Hematology; Department of Medicine; Mayo Clinic; Rochester; MN; USA

name: Division of Biomedical Statistics & Informatics; Mayo Clinic; Rochester; MN; USA

name: Department of Hematology and Oncology; Mayo Clinic; Phoenix; AZ; USA

name: Division of Hematopathology; Department of Laboratory Medicine and Pathology; Mayo Clinic; Rochester; MN; USA

ReferenceCitation: Rossi D, Spina V, Deambrogi C, Rasi S, Laurenti L, Stamatopoulos K, Arcaini L, Lucioni M, Rocque GB, Xu-Monette ZY, Visco C, Chang J, Chigrinova E, Forconi F, Marasca R, Besson C, Papadaki T, Paulli M, Larocca LM, Pileri SA, Gattei V, Bertoni F, Foà R, Young KH, Gaidano G. The genetics of Richter syndrome reveals disease heterogeneity and predicts survival after transformation. Blood. 2011 Mar 24;117(12):3391-401. doi: 10.1182/blood-2010-09-302174. Epub 2011 Jan 25.

name: Division of Hematology, Department of Clinical and Experimental Medicine, Amedeo Avogadro University of Eastern Piedmont, Novara, Italy;

name: Institute of Hematology, Catholic University of the Sacred Heart, Rome, Italy;

name: G. Papanicolaou Hospital, Thessaloniki, Greece;

name: Pathology, Fondazione IRCCS Policlinico San Matteo, University of Pavia, Pavia, Italy;

name: Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI;

name: Department of Hematopathology, The University of Texas M. D. Anderson Cancer Center, Houston, TX;

name: Department of Hematology, San Bortolo Hospital, Vicenza, Italy;

name: Oncology Institute of Southern Switzerland-IOSI, Bellinzona, Switzerland;

name: Division of Hematology, University of Siena, Siena, Italy;

name: Division of Hematology, University of Modena and Reggio Emilia, Modena, Italy;

name: Institute of Pathology, Catholic University of the Sacred Heart, Rome, Italy;

name: Haematopathology, Department L. & A. Seragnoli, University of Bologna, Bologna, Italy;

name: Centro di Riferimento Oncologico, Aviano, Italy; and

name: Division of Hematology, Department of Cellular Biotechnologies and Hematology, Sapienza University, Rome, Italy

ReferenceCitation: Fangazio M, De Paoli L, Rossi D, Gaidano G. Predictive markers and driving factors behind Richter syndrome development. Expert Rev Anticancer Ther. 2011 Mar;11(3):433-42. doi: 10.1586/era.10.237. Review.

title: Predictive markers and driving factors behind Richter syndrome development

ReferenceCitation: Rossi D, Rasi S, Spina V, Fangazio M, Monti S, Greco M, Ciardullo C, Famà R, Cresta S, Bruscaggin A, Laurenti L, Martini M, Musto P, Forconi F, Marasca R, Larocca LM, Foà R, Gaidano G. Different impact of NOTCH1 and SF3B1 mutations on the risk of chronic lymphocytic leukemia transformation to Richter syndrome. Br J Haematol. 2012 Aug;158(3):426-9. doi: 10.1111/j.1365-2141.2012.09155.x. Epub 2012 May 10.

name: Division of Haematology; Department of Translational Medicine; Amedeo Avogadro University of Eastern Piedmont; Novara; Italy

name: Institute of Haematology; Catholic University of the Sacred Heart; Rome; Italy

name: Pathology; Catholic University of the Sacred Heart; Rome; Italy

name: Onco-Haematology Department; Istituto di Ricovero e Cura a carattere Scientifico (IRCCS); Centro di Riferimento Oncologico della Basilicata; Rionero in Vulture; Italy

name: Division of Haematology; Department of Oncology and Haematology; University of Modena and Reggio Emilia; Modena; Italy

ReferenceCitation: Fabbri G, Rasi S, Rossi D, Trifonov V, Khiabanian H, Ma J, Grunn A, Fangazio M, Capello D, Monti S, Cresta S, Gargiulo E, Forconi F, Guarini A, Arcaini L, Paulli M, Laurenti L, Larocca LM, Marasca R, Gattei V, Oscier D, Bertoni F, Mullighan CG, Foá R, Pasqualucci L, Rabadan R, Dalla-Favera R, Gaidano G. Analysis of the chronic lymphocytic leukemia coding genome: role of NOTCH1 mutational activation. J Exp Med. 2011 Jul 4;208(7):1389-401. doi: 10.1084/jem.20110921. Epub 2011 Jun 13.

name: Institute for Cancer Genetics and the Herbert Irving Comprehensive Cancer Center, Department of Biomedical Informatics and Center for Computational Biology and Bioinformatics, Department of Pathology and Cell Biology, and Department of Genetics and Development, Columbia University, New York, NY 10032

name: Division of Hematology, Department of Clinical and Experimental Medicine and Interdisciplinary Research Center on Autoimmune Diseases, Amedeo Avogadro University of Eastern Piedmont, 28100 Novara, Italy

name: Department of Pathology, St. Jude Children’s Research Hospital, Memphis, TN 38105

name: Division of Hematology, University of Siena, 53100 Siena, Italy

name: Division of Hematology, Department of Cellular Biotechnologies and Hematology, Sapienza University, 00161 Rome, Italy

name: Division of Hematology, Department of Hematology Oncology, University of Pavia Medical School, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy

name: Institute of Pathology, University of Pavia, 27100 Pavia, Italy

name: Institute of Hematology and Institute of Pathology, Catholic University of the Sacred Heart, 00618 Rome, Italy

name: Division of Hematology, Department of Oncology and Hematology, University of Modena and Reggio Emilia, 41124 Modena, Italy

name: Clinical and Experimental Onco-Hematology, Centro di Riferimento Ocologico, Istituto di Ricovero e Cura a Carattere Scientifico, 33081 Aviano, Italy

name: Department of Hematology, Royal Bournemouth Hospital, Bournemouth BH7 7DW, UK

name: Oncology Institute of Southern Switzerland, CH-6500 Bellinzona, Switzerland

ReferenceCitation: Chigrinova E, Rinaldi A, Kwee I, Rossi D, Rancoita PM, Strefford JC, Oscier D, Stamatopoulos K, Papadaki T, Berger F, Young KH, Murray F, Rosenquist R, Greiner TC, Chan WC, Orlandi EM, Lucioni M, Marasca R, Inghirami G, Ladetto M, Forconi F, Cogliatti S, Votavova H, Swerdlow SH, Stilgenbauer S, Piris MA, Matolcsy A, Spagnolo D, Nikitin E, Zamò A, Gattei V, Bhagat G, Ott G, Zucca E, Gaidano G, Bertoni F. Two main genetic pathways lead to the transformation of chronic lymphocytic leukemia to Richter syndrome. Blood. 2013 Oct 10;122(15):2673-82. doi: 10.1182/blood-2013-03-489518. Epub 2013 Sep 4.

name: Lymphoma and Genomics Research Program, IOR Institute of Oncology Research, Bellinzona, Switzerland;

name: Oncology Institute of Southern Switzerland (IOSI), Bellinzona, Switzerland;

name: Dalle Molle Institute for Artificial Intelligence (IDSIA), Manno, Switzerland;

name: Swiss Institute of Bioinformatics, Lausanne, Switzerland;

name: Division of Hematology, Department of Translational Medicine, Amedeo Avogadro University of Eastern Piedmont, Novara, Italy;

name: Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, United Kingdom;

name: Haematology, Royal Bournemouth Hospital, Bournemouth, United Kingdom;

name: Hematology Department and HCT Unit, G. Papanicolaou Hospital, Thessaloniki, Greece;

name: Institute of Applied Biosciences, CERTH, Thessaloniki, Greece;

name: Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Université Lyon 1, Lyon, France;

name: Department of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, TX;

name: Department of Genetics and Pathology, Rudbeck Laboratory, Uppsala University, Uppsala, Sweden;

name: Department of Pathology and Microbiology, University of Nebraska Medical Center, Omaha, NE;

name: Department of Hematology Oncology, Hematology Unit and Division of Pathology, University of Pavia, Fondazione Istituto Di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia, Italy;

name: Department of Pathology, Center for Experimental Research and Medical Studies (CeRMS), University of Turin, Turin, Italy;

name: Division of Hematology, University of Turin, A.O.U. San Giovanni Battista, Turin, Italy;

name: Pathology, St. Gallen Hospital, St. Gallen, Switzerland;

name: Department of Molecular Genetics, Institute of Hematology and Blood Transfusion, Prague, Czech Republic;

name: Division of Hematopathology, Department of Pathology, University of Pittsburgh School of Medicine, Pittsburgh, PA;

name: Department of Internal Medicine III, Ulm University, Ulm, Germany;

name: Hospital Universitario Marques de Valdecilla, Santander, Spain;

name: 1st Department of Pathology and Experimental Cancer Research, Faculty of Medicine, Semmelweis University, Budapest, Hungary;

name: Department of Pathology, PathWest Laboratory Medicine WA, Nedlands, Australia;

name: Hematology Research Center of Russia, Moscow, Russian Federation;

name: Department of Pathology, University of Verona, Verona, Italy;

name: Clinical and Experimental Onco-Hematology Unit, Centro di Riferimento Oncologico, Aviano, Italy;

name: Columbia University Medical Center and New York Presbyterian Hospital, New York, NY; and

name: Department of Clinical Pathology, Robert-Bosch-Krankenhaus, and Dr. Margarete Fischer-Bosch Institute of Clinical Pharmacology, Stuttgart, Germany

ReferenceCitation: Scandurra M, Rossi D, Deambrogi C, Rancoita PM, Chigrinova E, Mian M, Cerri M, Rasi S, Sozzi E, Forconi F, Ponzoni M, Moreno SM, Piris MA, Inghirami G, Zucca E, Gattei V, Rinaldi A, Kwee I, Gaidano G, Bertoni F. Genomic profiling of Richter's syndrome: recurrent lesions and differences with de novo diffuse large B-cell lymphomas. Hematol Oncol. 2010 Jun;28(2):62-7. doi: 10.1002/hon.932.

ReferenceCitation: Fabbri G, Khiabanian H, Holmes AB, Wang J, Messina M, Mullighan CG, Pasqualucci L, Rabadan R, Dalla-Favera R. Genetic lesions associated with chronic lymphocytic leukemia transformation to Richter syndrome. J Exp Med. 2013 Oct 21;210(11):2273-88. doi: 10.1084/jem.20131448. Epub 2013 Oct 14.

name: Institute for Cancer Genetics, Herbert Irving Comprehensive Cancer Center, Department of Pathology and Cell Biology, Departments of Genetics and Development and of Microbiology and Immunology and Department of Biomedical Informatics and Center for Computational Biology and Bioinformatics, Columbia University, New York, NY 10032

name: Division of Hematology, Department of Hematology and Cellular Biotechnologies, Sapienza University, 00161 Roma, Italy

ReferenceCitation: Alizadeh AA, Eisen MB, Davis RE, Ma C, Lossos IS, Rosenwald A, Boldrick JC, Sabet H, Tran T, Yu X, Powell JI, Yang L, Marti GE, Moore T, Hudson J Jr, Lu L, Lewis DB, Tibshirani R, Sherlock G, Chan WC, Greiner TC, Weisenburger DD, Armitage JO, Warnke R, Levy R, Wilson W, Grever MR, Byrd JC, Botstein D, Brown PO, Staudt LM. Distinct types of diffuse large B-cell lymphoma identified by gene expression profiling. Nature. 2000 Feb 3;403(6769):503-11.

ReferenceCitation: Moulin C, Guillemin F, Remen T, Bouclet F, Hergalant S, Quinquenel A, Dartigeas C, Tausch E, Lazarian G, Blanchet O, Lomazzi S, Chapiro E, Schneider C, Nguyen-Khac F, Davi F, Hunault M, Tomowiak C, Roos-Weil D, Siebert R, Thieblemont C, Cymbalista F, Laribi K, Béné MC, Stilgenbauer S, Guièze R, Feugier P, Broséus J. Clinical, biological, and molecular genetic features of Richter syndrome and prognostic significance: A study of the French Innovative Leukemia Organization. Am J Hematol. 2021 Sep 1;96(9):E311-E314. doi: 10.1002/ajh.26239. Epub 2021 Jun 2.

name: Department of Hematology University Hospital of Nancy  Nancy France

name: Inserm, CHRU, University of Lorraine, CIC Clinical Epidemiology  Nancy France

name: Methodology, Data Management and Statistic Unit, MPI Department University Hospital of Nancy  Nancy France

name: Hematology Department, Clermont‐Ferrand University Hospital, Clermont Auvergne University  Clermont‐Ferrand France

name: Inserm UMRS1256 Nutrition‐Génétique et Exposition aux Risque Environnementaux (N‐GERE), University of Lorraine  Nancy France

name: University Hospital of Reims, Hôpital Robert Debré, Reims Champagne‐Ardenne University, Unité de Formation et de Recherche (UFR) Médecine  Reims France

name: Haematology Division University Hospital of Tours  Tours France

name: Department of Internal Medicine III Ulm University  Ulm Germany

name: Laboratoire d'hématologie, Hôpital Avicenne Assistance Publique‐Hôpitaux de Paris  Paris France

name: Biological Resource Center of Angers University Hospital of Angers  Angers France

name: Biological Resource Center of Nancy  Nancy France

name: Hematology Department Hôpital de la Pitié‐Salpêtrière, AP‐HP  Paris France

name: Department of Hematology University Hospital of Angers  Angers France

name: Department of Hematology CHU Poitiers  Poitiers France

name: CIC1402 Inserm Poitiers  Poitiers France

name: Department of Hematology Hôpital de la Pitié‐Salpêtrière, APHP  Paris France

name: Institute of Human Genetics Ulm University & Ulm University Medical Center  Ulm Germany

name: Department of Hematology Hôpital Saint‐Louis  Paris France

name: Department of Hematology Centre Hospitalier Le Mans  Le Mans France

name: Service d'Hématologie Biologique Pôle Laboratoires, CHU de Nantes  Nantes France

name: Université de Lorraine, CHRU‐Nancy, service d'hématologie biologique, pôle laboratoires  Nancy France


type: Registry Identifier

title: Search of Susceptibility Genes in Autism Spectrum Disorders

summary: The main objective of the study is to define, for Autism Spectrum Disorder, the extent of genetic variation in synaptic pathways that may be targeted for therapeutic development. For this purpose the investigators will take advantage of large, well-characterized cohorts of patients with Autism Spectrum Disorder for genetic screenings. Targeted sequencing of selected synaptic genes, previously associated with Autism Spectrum Disorder, will be carried out in these cohorts with deep coverage of coding regions and a strong focus on previously untested regulatory regions. Genomic data from Copy Number Variant, whole genome sequencing and exome sequencing, available for some of these patients, will be integrated in the overall analysis. The investigators will strongly emphasize the establishment of comprehensive genotype/phenotype correlations and set up an induced Pluripotent Stem Cells collection from selected patients with synaptic mutations for functional and expression analysis.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Delorme R, Ey E, Toro R, Leboyer M, Gillberg C, Bourgeron T. Progress toward treatments for synaptic defects in autism. Nat Med. 2013 Jun;19(6):685-94. doi: 10.1038/nm.3193. Epub 2013 Jun 6. Review.

family: Delorme

full_name: Richard Delorme

given: Richard

sequence: first

family: Ey

full_name: Elodie Ey

given: Elodie

sequence: additional

family: Toro

full_name: Roberto Toro

given: Roberto

family: Leboyer

full_name: Marion Leboyer

given: Marion

family: Gillberg

full_name: Christopher Gillberg

given: Christopher

family: Bourgeron

full_name: Thomas Bourgeron

given: Thomas

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Nature Medicine

oa_host_type: repository

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

host_type: repository

license_normalized: no license

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

repository_normalized: HAL

version: submittedVersion

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

ReferenceType: derived

ReferenceCitation: Latimier A, Kovarski K, Peyre H, Fernandez LG, Gras D, Leboyer M, Zalla T. Trustworthiness and Dominance Personality Traits' Judgments in Adults with Autism Spectrum Disorder. J Autism Dev Disord. 2019 Nov;49(11):4535-4546. doi: 10.1007/s10803-019-04163-1.

family: Latimier

full_name: Alice Latimier

given: Alice

family: Kovarski

full_name: Klara Kovarski

given: Klara

family: Peyre

full_name: Hugo Peyre

given: Hugo

family: Fernandez

full_name: Laura Gabriela Fernandez

given: Laura Gabriela

family: Gras

full_name: Doriane Gras

given: Doriane

family: Zalla

full_name: Tiziana Zalla

given: Tiziana

bso_classification: Social sciences

journal_name: Journal of Autism and Developmental Disorders

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

title: Trustworthiness and Dominance Personality Traits’ Judgments in Adults with Autism Spectrum Disorder

ReferenceCitation: Gréa H, Scheid I, Gaman A, Rogemond V, Gillet S, Honnorat J, Bolognani F, Czech C, Bouquet C, Toledano E, Bouvard M, Delorme R, Groc L, Leboyer M. Clinical and autoimmune features of a patient with autism spectrum disorder seropositive for anti-NMDA-receptor autoantibody. Dialogues Clin Neurosci. 2017 Mar;19(1):65-70.

lead_sponsor: Institut National de la Santé Et de la Recherche Médicale, France

location_facility:
Albert Chenevier Hospital
Robert Debré Hospital

lead_sponsor_type: academique

status_simplified: Unknown


title: A Prospective Study for the Treatment of Severe Pulmonary Embolism With Pharmacodynamic Thrombectomy

acronym: RESPIRE

summary:
The mortality of severe pulmonary embolisms admitted to the resuscitation department for circulatory failure remains in the range of 30-40% at the acute phase. Hemodynamic failure is the leading cause of death. These patients frequently have a contraindication to thrombolysis. Surgical pulmonary arterial desobstruction still leads to significant hospital mortality and can't be implemented in all hospitals. Concerning advanced hemodynamic support techniques, they can't always reduce mortality on themselves. There is therefore a need for developing alternative approaches for less invasive pulmonary arterial desobstruction. Data on the efficacy and safety of percutaneous methods of desobstruction are still too limited to implement them in current practice.

AngioJet ™ PE is a device CE marked for intra-arterial desobstruction of pulmonary arteries. It has been successfully tested in more than 25 patients with pulmonary embolism in France. Before considering a request for reimbursement from the HAS it is necessary to have propective data of sufficient quality. This phase 2a prospective study is proposed to evaluate the efficacy and safety of the AngioJet ™ PE catheter use. The resulting data will allow us to submit a Phase 3 controlled study to an upcoming PHRC-type project call.

study_start_date_type: Actual

status: Recruiting

study_type: Interventional

primary_purpose: Treatment

ipd_sharing: Yes

ipd_sharing_description: Individual participant data that underlie results in publication could be shared Individual participant data detailed in meta analysis protocol could be shared

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: AP-HP - Hôpital Européen Georges-Pompidou Paris

intervention_type: Device

status_simplified: Ongoing


title: Electric Neuromodulation in Refractory Obsessive-compulsive Disorder : the Montpellier Experience (France)

acronym: NEP-TOC

summary:
Obsessive-compulsive disorder (OCD) is a neuropsychiatric disease characterised by intrusive, recurrent and persistent thoughts, urges or images (obsessions) and the resulting excessive repetitive behaviours or mental acts according to rigid rules unrealistically aimed at reducing distress (compulsions).

Its lifetime prevalence in the general population is usually estimated between 1 - 3% (Ruscio, Mol Psychiatry, 2010). Despite appropriate pharmacological and cognitive-behavioural treatments, it is commonly estimated that 10% of patients are therapy-refractory and that among improved or recovered patients, sustained efficacy is uncertain.

For treatment refractory OCD patients, a neurosurgical treatment by deep brain stimulation (DBS), has emerged in the late 1990s as a new therapeutic option (Nuttin et al, Lancet, 1999).

The objective of the current study is to report the long-term treatment effects (safety and effectiveness) of DBS from the cohort of six severe and therapy-refractory OCD patients implanted at the French university hospital of Montpellier since 2003.

status: Completed

study_completion_date_type: Actual

time_perspective: Retrospective

enrollment_type: Actual

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

intervention_type: Procedure

status_simplified: Completed


title: 3 Dimensional Study of Lower Limbs and Feet of Children in Standing Position

summary:
The study will be in 3 parts: first one will be to address the key question of the lower limb frontal alignment based on both three-dimensional measurements of low-dose bi-planar X-rays and foot morphology assessment. Indeed, a major issue in the management of lower limb disorders is the ability to correctly assess abnormal development and decide on the most adapted treatment option. In particular, the link between lower limb disorders and foot morphology remain unclear. Recently, quantitative 3D measurement of the lower limb in children has been successfully assessed using low-dose biplanar X-rays.

Second part will be to assess the reproducibility of the 3dimensional reconstructions whether they are made by a radiology technician, or by a so-called expert through collecting datas from 3 centers of pediatric surgery where EOS Imaging system is daily used to get spine or lower limb X-Rays.

Last part will be to work on the recently developed weight-bearing foot 3D reconstruction method for clinical use using the Parametric Personalized Modelling approach (PPM). This will allow having a better understanding and evaluation of foot's anatomy and patho-anatomy.

primary_purpose: Diagnostic

lead_sponsor: Fondation Lenval

location_facility:
Hôpital Necker enfants Malades
Fondation Lenval

intervention_type: Other

lead_sponsor_type: industriel


title: Burnout Determinants Among Pediatric Psychiatry Workers During COVID-19 Epidemic in Occitanie Region in France

summary:
Burnout among health workers is at core of our current preoccupations because of the health crisis we're going trough. Indeed, COVID-19 epidemic had terrible consequences not only on global mental health both in adults and children, but also on Health workers mental health. The investigators chose to consider Pediatric Psychiatry workers because of their particular position in this crisis.

The aim of the study is to point out burnout determining factors among Pediatric Psychiatry workers in Occitanie during COVID-19 crisis, by the use of an online questionnaire including the Copenhagen Burnout Inventory.


title: Is There A LIfe for DES After Discontinuation of Clopidogrel:The ITALIC PLUS Trial

acronym: ITALICplus

summary: The ITALIC PLUS Trial was designed with the objective of extending to other countries the enrollment of patients into the ITALIC trial initially conducted in France, in order to achieve statistical significance by pooling the data of both trials.

ReferenceCitation: Gilard M, Barragan P, Noryani AAL, Noor HA, Majwal T, Hovasse T, Castellant P, Schneeberger M, Maillard L, Bressolette E, Wojcik J, Delarche N, Blanchard D, Jouve B, Ormezzano O, Paganelli F, Levy G, Sainsous J, Carrie D, Furber A, Berland J, Darremont O, Le Breton H, Lyuycx-Bore A, Gommeaux A, Cassat C, Kermarrec A, Cazaux P, Druelles P, Dauphin R, Armengaud J, Dupouy P, Champagnac D, Ohlmann P, Endresen K, Benamer H, Kiss RG, Ungi I, Boschat J, Morice MC. 6- versus 24-month dual antiplatelet therapy after implantation of drug-eluting stents in patients nonresistant to aspirin: the randomized, multicenter ITALIC trial. J Am Coll Cardiol. 2015 Mar 3;65(8):777-786. doi: 10.1016/j.jacc.2014.11.008. Epub 2014 Nov 16.

family: Gilard

full_name: Martine Gilard

given: Martine

family: Barragan

full_name: Paul Barragan

given: Paul

family: Noryani

full_name: Arif A.L. Noryani

given: Arif A.L.

family: Noor

full_name: Hussam A. Noor

given: Hussam A.

family: Majwal

full_name: Talib Majwal

given: Talib

family: Hovasse

full_name: Thomas Hovasse

family: Castellant

full_name: Philippe Castellant

given: Philippe

family: Schneeberger

full_name: Michel Schneeberger

given: Michel

family: Maillard

full_name: Luc Maillard

given: Luc

family: Bressolette

full_name: Erwan Bressolette

given: Erwan

family: Wojcik

full_name: Jaroslaw Wojcik

given: Jaroslaw

family: Delarche

full_name: Nicolas Delarche

given: Nicolas

family: Blanchard

full_name: Didier Blanchard

given: Didier

family: Jouve

full_name: Bernard Jouve

given: Bernard

family: Ormezzano

full_name: Olivier Ormezzano

given: Olivier

family: Paganelli

full_name: Franck Paganelli

given: Franck

family: Levy

full_name: Gilles Levy

given: Gilles

family: Sainsous

full_name: Joël Sainsous

given: Joël

family: Carrie

full_name: Didier Carrie

family: Furber

full_name: Alain Furber

given: Alain

family: Berland

full_name: Jacques Berland

given: Jacques

family: Darremont

full_name: Oliver Darremont

given: Oliver

family: Le Breton

full_name: Hervé Le Breton

given: Hervé

family: Lyuycx-Bore

journal_name: Journal of the American College of Cardiology

title: 6- Versus 24-Month Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stents in Patients Nonresistant to Aspirin


title: Pilot Observational and Analytic Study of Practices and Organizations Related to Emerging Occupations of Care Coordination in Oncology: Modeling the Concept of Care Coordination in Oncology (EPOCK)

acronym: EPOCK

summary: Several stakeholders are implied in cancer care pathways and there is a need for coordinating their actions. New occupations of care coordination have thus emerged. However, the conditions of their efficiency have been too few reported and included discrepancies between reports. In this context, the main objective is to propose a modeling of care coordination and associated emerging occupations (nurse-based) by comparing theoretical expected outcomes to professionals, patients and caregivers representations.

time_perspective: Cross-Sectional

ReferenceCitation: Colombani F, Sibé M, Kret M, Quintard B, Ravaud A, Saillour-Glénisson F. EPOCK study protocol: a mixed-methods research program evaluating cancer care coordination nursing occupations in France as a complex intervention. BMC Health Serv Res. 2019 Jul 12;19(1):483. doi: 10.1186/s12913-019-4307-7.

family: Colombani

full_name: F. Colombani

given: F.

family: Sibé

full_name: M. Sibé

given: M.

family: Kret

full_name: M. Kret

family: Quintard

full_name: B. Quintard

given: B.

family: Ravaud

full_name: A. Ravaud

given: A.

family: Saillour-Glénisson

full_name: F. Saillour-Glénisson

currency_apc_doaj: GBP

journal_name: BMC Health Services Research

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Universite de Bordeaux - Oskar-Bordeaux

evidence: oa repository (via pmcid lookup)

repositories_institution:
PubMed Central - Europe PMC
Universite de Bordeaux - Oskar-Bordeaux

ipd_sharing: No

lead_sponsor: University Hospital, Bordeaux

location_facility:
Clinique Tiivoli Ducos
CHU de Bordeaux
HAD Bagatelle
Institut Claudius Regaud
Institut Curie
CH de Libourne
Institut Sainte Catherine
CH Sud Gironde
Institut de Cancérologie de la Loire
CHU de Toulouse

intervention_type: Behavioral


title: Immune Response After COVID19 Vaccination in a Multicenter Cohort of In-center Haemodialysis Patients in France

acronym: COVADIAL

summary: COVID-19 is a severe disease with poor prognosis in patients receiving in-center haemodialysis (HD). A population-based registry of >4,000 patients with a diagnosis of COVID-19 receiving kidney replacement therapy (either haemodialysis or kidney transplant recipient) highlighted a 21.1 fold higher 28-day mortality risk among patients on dialysis (n = 3,285), than the expected 1.2% mortality of propensity-score matched historical controls. Vulnerability in uraemic patients is a combination of intrinsic frailty, increased risk of infection and a high burden of comorbidities. In patients on HD, abnormalities in the immune response may contribute to relative hyporesponsiveness to vaccines. However, patients on HD appear to seroconvert at a similar rate compared to the general population after SARS-CoV-2 infection, suggesting a likelihood of vaccine efficacy but this population has been excluded from vaccine trials. The primary aim of this study is to evaluate antibody synthesis induced after Covid-19 vaccination in a French adult multicentric cohort of in-center haemodialysis patients. The second aim of this study is to identify vaccine non-responders among HD patients and to assess the clinical and biological risk factors associated with non-response.

ReferenceType: result

ReferenceCitation: Jager KJ, Kramer A, Chesnaye NC, Couchoud C, Sánchez-Álvarez JE, Garneata L, Collart F, Hemmelder MH, Ambühl P, Kerschbaum J, Legeai C, Del Pino Y Pino MD, Mircescu G, Mazzoleni L, Hoekstra T, Winzeler R, Mayer G, Stel VS, Wanner C, Zoccali C, Massy ZA. Results from the ERA-EDTA Registry indicate a high mortality due to COVID-19 in dialysis patients and kidney transplant recipients across Europe. Kidney Int. 2020 Dec;98(6):1540-1548. doi: 10.1016/j.kint.2020.09.006. Epub 2020 Oct 15.

family: Jager

full_name: Kitty J. Jager

given: Kitty J.

family: Kramer

full_name: Anneke Kramer

given: Anneke

family: Chesnaye

full_name: Nicholas C. Chesnaye

given: Nicholas C.

family: Couchoud

full_name: Cécile Couchoud

given: Cécile

family: Sánchez-Álvarez

full_name: J. Emilio Sánchez-Álvarez

given: J. Emilio

family: Garneata

full_name: Liliana Garneata

given: Liliana

family: Collart

full_name: Fréderic Collart

given: Fréderic

family: Hemmelder

full_name: Marc H. Hemmelder

given: Marc H.

family: Ambühl

full_name: Patrice Ambühl

given: Patrice

family: Kerschbaum

full_name: Julia Kerschbaum

given: Julia

family: Legeai

full_name: Camille Legeai

given: Camille

family: del Pino y Pino

full_name: María Dolores del Pino y Pino

given: María Dolores

family: Mircescu

full_name: Gabriel Mircescu

given: Gabriel

family: Mazzoleni

full_name: Lionel Mazzoleni

given: Lionel

family: Hoekstra

full_name: Tiny Hoekstra

given: Tiny

family: Winzeler

full_name: Rebecca Winzeler

given: Rebecca

family: Mayer

full_name: Gert Mayer

given: Gert

family: Stel

full_name: Vianda S. Stel

given: Vianda S.

family: Wanner

full_name: Christoph Wanner

given: Christoph

family: Zoccali

full_name: Carmine Zoccali

given: Carmine

family: Massy

full_name: Ziad A. Massy

given: Ziad A.

journal_name: Kidney International

oa_colors: green hybrid

evidence: open (via crossref license)

ReferenceCitation: ERA-EDTA Council; ERACODA Working Group. Chronic kidney disease is a key risk factor for severe COVID-19: a call to action by the ERA-EDTA. Nephrol Dial Transplant. 2021 Jan 1;36(1):87-94. doi: 10.1093/ndt/gfaa314.

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

ReferenceCitation: Eleftheriadis T, Antoniadi G, Liakopoulos V, Kartsios C, Stefanidis I. Disturbances of acquired immunity in hemodialysis patients. Semin Dial. 2007 Sep-Oct;20(5):440-51. Review.

ReferenceCitation: Mahalingasivam V, Tomlinson L. The seroprevalence of SARS-CoV-2 in patients on haemodialysis. Nat Rev Nephrol. 2021 Apr;17(4):225-226. doi: 10.1038/s41581-020-00379-y.


title: Impact of Auditory Stimulation in Eating Pleasure : Multicentric Study With Biscuits With Crunchy Texture vs Soft Texture in 100 Seniors Affected or at Risk of Presbyacusis

acronym: EDERE 2021

summary:
Background. Decreased taste and smell contribute to loss of appetite (anorexia), and the resulting protein-energy malnutrition increases the frailty of the elderly. The risk of falls, disability, infections and depression often requires them to be institutionalized. Elderly, undernourished and toothless patients often complain about the monotony of a soft, mixed-texture diet. In a previous study, some participants highlighted the pleasure of crunching cookies that have a solid texture that can be eaten in any dental condition. However, the age-related decrease in hearing (presbyacusis) is frequent and progressive from the age of 60. The hypothesis of this work is that older patients may perceive a crunchy food crunching in their mouth, despite presbycusis. If the hypothesis is verified, this would make geriatric caregivers aware of the possibility of diversifying the texture of food, in order to stimulate the pleasure of eating and increase the dietary intake in this population of patients who are often undernourished, dysphagic, edentulous and hearing impaired. The originality of this study is to share the expertise of geriatricians and specialists in mastication/swallowing (dental surgeon, speech-language pathologist), hearing (ENT doctor, hearing care professional) and nutrition (dietician).

Type of study. Type of study MR-004 "Research not involving the human person". Protocol. Compare the noise and pleasure of crunching between two hyperprotein nutritional supplements: a soft filled cookie (Nutra Cake™, Délical, France) and a crunchy cookie of the Breton type (Protibis™, Solidages, France). Blind study impossible: each subject will eat a cookie then the other in a random order and will be his own control. The tests will be performed without the possible hearing aids, but with or without the dentures according to the patient's preference. Indeed, some patients have dental prostheses that are no longer suitable for chewing, and that they wear only for aesthetics. Objective. Validate the evaluation criteria "Do you hear the biscuit crunch?" and "Is it a pleasure?" If so, encourage diversification with crunchy foods with a suitable texture, as well as dental and prosthetic rehabilitation of dependent elderly people.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Evaluation of Indices of Body Composition During Ultramarathon : Measure by Body Bioelectrical Impedance

acronym: IMPETRAIL

summary: Prospective cohort, monocentric non-randomized and interventional clinical study in ICU assessing the evolution of body composition using bioelectrical impedance analysis.

design_allocation: Non-Randomized

lead_sponsor: University Hospital, Clermont-Ferrand


title: Assessing the Impact of the COVID-19 Lockdown on Metabolic Control and Access to Health Care in Patients With Diabetes: a Monocentric Cross-sectional Study

acronym: CONFI-DIAB

summary:
The outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the COVID-19 (Coronavirus Disease-2019) in December 2019 has led to an unprecedented international health situation. Exceptional measures have been taken by public authorities worldwide in order to slow the spread of the virus and prevent healthcare systems from becoming overloaded. In France, a national lockdown has been established during approximately 2 months to increase social distancing and restrict population movements. Hospital routine care appointments have been cancelled, in order to reallocate medical resources towards COVID-19 units and limit contacts between patients within hospitals or waiting rooms. While the virus itself, the disease and potential treatments are currently extensively studied, little data are available on the effect of these public health decisions on the management of a chronic condition such as diabetes.

The French regional CONFI-DIAB study aims at assessing the collateral impact of routine care cancellation during the national lockdown due to COVID-19 in patients with a chronic condition such as diabetes. Special attention will be given to metabolic control and access to health care.

This cross-sectional study should provide information on the consequences of a global lockdown and the associated routine care cancellation on the management of diabetes, and inform future decision making in the event of a new pandemic.

study_start_date_type: Anticipated

ReferenceCitation: Ludwig L, Scheyer N, Remen T, Guerci B. The Impact of COVID-19 Lockdown on Metabolic Control and Access to Healthcare in People with Diabetes: the CONFI-DIAB Cross-Sectional Study. Diabetes Ther. 2021 Aug;12(8):2207-2221. doi: 10.1007/s13300-021-01105-y. Epub 2021 Jul 9.

family: Ludwig

full_name: Lisa Ludwig

given: Lisa

family: Scheyer

full_name: Nicolas Scheyer

given: Nicolas

family: Remen

full_name: Thomas Remen

given: Thomas

family: Guerci

full_name: Bruno Guerci

given: Bruno

journal_name: Diabetes Therapy

license: cc-by-nc

license_normalized: cc-by-nc

lead_sponsor: Central Hospital, Nancy, France


title: Non-interventional Study Evaluating Plerixafor-based Mobilization for Salvage Autologous Hematopoietic Stem Cell Transplantation in Relapsed Myeloma

summary:
Multiple myeloma (MM) is an incurable disease that is characterized by the accumulation of clonal plasma cells in the bone marrow. While MM patients with relapsed disease may achieve responses to subsequent antimyeloma therapies, the duration of response decreases with successive relapses until resistant disease develops. Until recently, the median survival following relapse after induction therapy was approximately one year. The relatively recent US Food and Drug Administration (FDA) approvals of bortezomib (2003) and combination lenalidomide plus dexamethasone (2006) therapies for the treatment of previously treated MM has provided effective therapeutic options that give patients with relapsed or refractory MM the prospect for a prolongation of overall and progression-free survival times. However, MM remains an incurable disease. A clear unmet medical need still exists for additional novel therapeutic options for the treatment of previously treated MM.

Plerixafor reversibly inhibits CXCR4 binding to stromal cell derived factor (SDF)-1alpha and was recently discovered to be an effective agent to mobilize CD34+ cells into the peripheral blood. In normal volunteers, administering Plerixafor after 4-5 days of G-CSF resulted in a 3-3.5 fold increase in circulating CD34+ cells. Two phases 3 studies demonstrated that the combination of G-CSF and Plerixafor is superior to G-CSF alone for mobilizing hematopoietic progenitor cells in front-line or as salvage therapy in patients with multiple myeloma.

Nevertheless, almost all patients ultimately relapse, and no plateau is observed in the survival curves. At the time of disease recurrence, there is not one standard salvage approach, but instead, various therapeutic options are available, including novel agents-based therapy, administered for a fixed duration of time or until progression. In the pivotal trial for the approval of bortezomib as monotherapy in relapsed and refractory MM, the median PFS was 7 months, whereas in the pivotal trials for the approval of lenalidomide in combination with dexamethasone in the same group of patients, the median time to progression was approximately 11 months. A more recent prospective, randomized, phase 3 study has shown that a triplet combination of bortezomib, thalidomide and dexamethasone (VTD) achieved superior results compared to thalidomide dexamethasone (TD) alone in patients relapsing following ASCT, with a median time to progression of 19.5 versus 13.8 months, respectively. This study suggests that combinations consisting of both an IMiD and a proteasome inhibitor are a valuable option at the time of relapse.

However, when a frozen graft is available, it is also possible to repeat high-dose therapy in patients who previously responded to the frontline application of high-dose melphalan and ASCT. Over time, several reports have demonstrated the feasibility of this salvage strategy. The majority of data are available from retrospective studies and are based on single-centre experiences with small numbers of selected patients. In this setting, PFS has been shown to range from 7 to 22 months, and the treatment-related mortality (TRM) was acceptable, ranging from 0 to 8%. Various prognostic factors for prolonged PFS have been described, such as the duration of response to the first high-dose therapy, or the number of lines of therapy prior to salvage ASCT.

With this background, this prospective non-interventional multicentre study will aim to collect data on the feasibility of salvage ASCT using a Plerixafor-based stem cell mobilization in relapsed MM, according to Plerixafor label in France.

This is a non-interventional study; visit will be performed as usual, according to each center practices. No additional visits will be requested for the study purpose. The date for each visit and any data generated must be recorded on the appropriate eCRF.

The study will consist of 3 periods:

An early screening period
Autologous stem cell mobilization period
High dose melphalan therapy and autologous graft infusion and follow-up for12 months after salvage ASCT Inclusion visit

This visit may occur up to 28 days before Mozobil® administration. This visit will be performed during the visit of pre-transplant assessment. For the pre-transplant assessment, the procedures are performed routinely before ASCT even if the patient is not included in the study:

Stem cell mobilization phase The stem cell mobilization phase is performed according to standard practice of each participating centre.

Follow-up visits High dose melphalan administration and autologous graft infusion will be performed according to each centre standard practice. Patients will be followed according to each center practices. The follow-up of this non-interventional study will end 12 months after ASCT.

Subjects will be enrolled over a 2 years period. The total duration of the study will be 36 months

lead_sponsor: Association for Training, Education, and Research in Hematology, Immunology, and Transplantation

location_facility: Hématologie Clinique, Hôpital Saint Antoine


title: PREPARE Work Package 3 -Development of a Serocorrelate of Protection Against GBS - Protocol Harmonisation.

summary: A multicentre, international case-control study to develop a biobank of sera from 150 cases of serotype III GBS disease and associated clinical information from seven countries (Malawi, Uganda, UK, the Netherlands, Italy and France), with 3:1 (450) serotype matched healthy controls.

lead_sponsor: St George's, University of London

location_country:
Italy
Netherlands
France
Uganda
United Kingdom
Malawi

location_facility: Azienda Ospedaliero-Universitaria di Modena (AOU)

location_facility: Queen Elizabeth Central Hospital College of Medicine, P.O. Box 30096 Chichiri,

location_facility: Assistance Publique Hopitaux de Paris (AP-HP)

location_facility: MUJHU - Makerere University Johns Hopkins University Research Collaboration/MUJHU Care Ltd

location_facility: Academisch Medisch Centrum,Universiteit van Amsterdam


title: REACT AGAINST STROKE

acronym: AVC - REACT

summary:
Acute stroke management represents a true medical emergency that requires prompt diagnosis and urgent treatment. In a previous exhaustive cohort study conducted in the Rhône region, France (AVC69) the investigators observed that only a small percentage of patients could access to thrombolysis in time. In this cohort of 1306 patients treated in one of the emergency department of the Rhone region for a suspected stroke, 84% of patients reached hospital through an emergency department instead of going directly to a stroke unit. Among those patients, only 8% were finally thrombolysed, because of extended management times.. Our hypothesis was that public awareness campaign designed to improve public's knowledge and skills would consequently reduce prehospital time and favour call to prehospital emergency medical services (EMS).

The investigators will conduct an awareness campaign aimed at the general population, using different communication media, the content will be developed based on the results of a qualitative study with focus groups (Quali-AVC), and using a diffusion plan established with communications professionals. To assess the effects of this campaign, a comparative quasi-experimental before-after study will be conducted. A control region where no awareness stroke program has been set up has been selected, data will be collected in the two regions. The assessment of the impact of the campaign will focus on the comparison of the evolution of indicators between these two regions. Three assessment time will be provided: before starting the program, at 3 months and at the end of the program.

ReferenceCitation: Haesebaert J, Laude C, Termoz A, Bravant E, Perreton N, Bony T, Trehard H, Porthault S, Derex L, Nighoghossian N, Schott AM. Impact of a theory-informed and user-centered stroke information campaign on the public's behaviors, attitudes, and knowledge when facing acute stroke: a controlled before-and-after study. BMC Public Health. 2020 Nov 16;20(1):1712. doi: 10.1186/s12889-020-09795-y.

apc_source: openAPC

family: Haesebaert

full_name: Julie Haesebaert

given: Julie

family: Laude

full_name: Caroline Laude

given: Caroline

family: Termoz

full_name: Anne Termoz

given: Anne

family: Bravant

full_name: Estelle Bravant

given: Estelle

family: Perreton

full_name: Nathalie Perreton

given: Nathalie

family: Bony

full_name: Thomas Bony

family: Trehard

full_name: Hélène Trehard

given: Hélène

family: Porthault

full_name: Sylvie Porthault

given: Sylvie

family: Derex

full_name: Laurent Derex

given: Laurent

family: Nighoghossian

full_name: Norbert Nighoghossian

given: Norbert

family: Schott

full_name: Anne-Marie Schott

given: Anne-Marie

journal_name: BMC Public Health

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

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

evidence: oa repository (via page says license)

repository_normalized: Research Square

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

repository_institution: Research Square - Research Square

title: Impact of a theory-informed and user-centered stroke information campaign on the public’s behaviors, attitudes, and knowledge when facing acute stroke: a controlled before-and-after study

location_facility: Pôle Information Médicale, Evaluation, Recherche 162 avenue Lacassagne


title: "Prospective Multicenter Observational Study for the Evaluation of the Efficacy of the Cordis Enterprise(TM) Self-expanding Intracranial Stent: Enterprise Stent Aneurysm Treatment (ESAT) Study

acronym: ESAT

summary: The purpose of this study is to evaluate the morbidity, mortality, and efficacy of use of the Enterprise(TM) stent for the treatment of (ruptured or non-ruptured) intracranial aneurysms.

lead_sponsor: Codman & Shurtleff

location_facility:
Albert Michallon Hospital
Pitie Salpetriere Hospital
Purpan Hospital
Timone Hospital
Jean Minjoz Hospital
La Pitie Salpetriere Hospital
La Pitie Salpetiere Hospital
White House Hospital
Pellegrin Hospital
Lariboisiere Hospital
Rothschild Foundation
Beaujon Hospital
Roger Salengro Hospital
CHU Amiens


title: An Open-Label Study to Examine the Safety and Efficacy, of WR 279,396 (Paromomycin + Gentamicin Topical Cream) for the Treatment of Cutaneous Leishmaniasis in France

acronym: PAGELEC

summary: The objectives of the study are to evaluate the safety and efficacy of open label treatment with WR 279,396 (topical paromomycin & gentamicin) in patients with non-complicated, non-severe cutaneous leishmaniasis (CL).

location_facility: Centre d'investigations cliniques- Hopital Robert Debré

intervention_type: Drug


title: Pharmacists in Detecting Opioid Misuse Using the Prescription Opioid Misuse Index (POMI): Survey in a Region in the South of France, Occitanie-Est

summary:
Opioid use is increasing in Western countries and is associated with harms as hospitalization, addiction and deaths(1). Community pharmacists interact frequently with patients, giving them the opportunity to identify and prevent the risk of prescribed opioid misuse. The purpose of this study was therefore to assess the risk of prescribed opioids misuse in ambulatory patients with chronic non-cancer pain (CNCP) seen in community pharmacies.

Method: A questionnaire (including the Prescription Opioid Misuse POMI(2)) have been proposed to patients with opioid prescription by pharmacy students, in 86 pharmacies of Occitanie-Est, in April 2019. Eligible patients were adults with CNCP that consented to participate.

A total of 414 patients (62.4% women, mean age 58 ± 16.00) have been included. The main pains were spinal (37.3%) and osteoarticular (33.1%). The median visual analog scale (VAS) was 7 [IQR25-75: 5-8]. The prescribed opioids are mainly weak opioids (73.2%): paracetamol/tramadol (35%), paracetamol/codeine (17.4%), paracetamol/opium (16.8%). Strong opioids (32.6%) were oxycodone (11.95%), fentanyl (9%), and morphine (9%). The median morphine milligram equivalent (MME) was 40 mg/day [IQR25-75: 20-80].

POMI score was superior to 2/6 in 45.4% and superior to 4 in 16%. The main positive question were feel high (40.3%), take the opioid more often (39.3%), take more medication (36.6), and need to early renew opioid medication earlier (30.8%).

Patients with POMI score > 4 were younger (49 years versus 55.9; p<0.01), more urban (78.1% versus 69.2%; p=0.03), had higher VAS (7.3 versus 6.2; p<0.01), received higher median MME (112 mg versus 64.9 mg; p<0.01), and consumed more strong opioid (45.3% versus 27.3%; p=0.04).


title: Use of the French Healthcare Insurance Database to Evaluate How Early Diagnosis of Hepatocellular Carcinomas is Implemented in France: SAMHEPAT Study

acronym: SAMHEPAT

summary: Hepatocellular carcinoma (HCC) has become the second most common cause of cancer death in the world, estimated responsible for nearly 745,000 deaths in 2012 (9.1% of all cancer deaths).

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Quantitative and Prognostic Evaluation of Dense Red Blood Cells in Sickle Cell Children: Single-center Study From the Creteil (France) Pediatric Cohort

acronym: DREPADENSE

summary: Quantitative and prognostic evaluation of dense red blood cells in sickle cell children: preliminary single center study from the Creteil pediatric cohort.

status: Terminated

ReferenceCitation: Miller ST, Sleeper LA, Pegelow CH, Enos LE, Wang WC, Weiner SJ, Wethers DL, Smith J, Kinney TR. Prediction of adverse outcomes in children with sickle cell disease. N Engl J Med. 2000 Jan 13;342(2):83-9.

ReferenceCitation: Benkerrou M, Alberti C, Couque N, Haouari Z, Ba A, Missud F, Boizeau P, Holvoet L, Ithier G, Elion J, Baruchel A, Ducrocq R. Impact of glucose-6-phosphate dehydrogenase deficiency on sickle cell anaemia expression in infancy and early childhood: a prospective study. Br J Haematol. 2013 Dec;163(5):646-54. doi: 10.1111/bjh.12590. Epub 2013 Oct 10.

ReferenceCitation: Quinn CT, Shull EP, Ahmad N, Lee NJ, Rogers ZR, Buchanan GR. Prognostic significance of early vaso-occlusive complications in children with sickle cell anemia. Blood. 2007 Jan 1;109(1):40-5. Epub 2006 Aug 29.

ReferenceCitation: Bernaudin F, Verlhac S, Arnaud C, Kamdem A, Chevret S, Hau I, Coïc L, Leveillé E, Lemarchand E, Lesprit E, Abadie I, Medejel N, Madhi F, Lemerle S, Biscardi S, Bardakdjian J, Galactéros F, Torres M, Kuentz M, Ferry C, Socié G, Reinert P, Delacourt C. Impact of early transcranial Doppler screening and intensive therapy on cerebral vasculopathy outcome in a newborn sickle cell anemia cohort. Blood. 2011 Jan 27;117(4):1130-40; quiz 1436. doi: 10.1182/blood-2010-06-293514. Epub 2010 Nov 10.

ReferenceCitation: Bartolucci P, Brugnara C, Teixeira-Pinto A, Pissard S, Moradkhani K, Jouault H, Galacteros F. Erythrocyte density in sickle cell syndromes is associated with specific clinical manifestations and hemolysis. Blood. 2012 Oct 11;120(15):3136-41. doi: 10.1182/blood-2012-04-424184. Epub 2012 Aug 23. Erratum in: Blood. 2014 Mar 20;123(12):1972.

ReferenceCitation: Thornburg CD, Files BA, Luo Z, Miller ST, Kalpatthi R, Iyer R, Seaman P, Lebensburger J, Alvarez O, Thompson B, Ware RE, Wang WC; BABY HUG Investigators. Impact of hydroxyurea on clinical events in the BABY HUG trial. Blood. 2012 Nov 22;120(22):4304-10; quiz 4448. doi: 10.1182/blood-2012-03-419879. Epub 2012 Aug 22. Erratum in: Blood. 2016 Dec 15;128(24):2869.

ReferenceCitation: Yawn BP, Buchanan GR, Afenyi-Annan AN, Ballas SK, Hassell KL, James AH, Jordan L, Lanzkron SM, Lottenberg R, Savage WJ, Tanabe PJ, Ware RE, Murad MH, Goldsmith JC, Ortiz E, Fulwood R, Horton A, John-Sowah J. Management of sickle cell disease: summary of the 2014 evidence-based report by expert panel members. JAMA. 2014 Sep 10;312(10):1033-48. doi: 10.1001/jama.2014.10517. Review. Erratum in: JAMA. 2014 Nov 12;312(18):1932. JAMA. 2015 Feb 17;313(7):729.

lead_sponsor: Centre Hospitalier Intercommunal Creteil


title: Chronic Effects of Local Vibration on Neuromuscular Reconditioning After Anterior Cruciate Ligament Reconstruction

summary:
These last years, it has been proven that the solicitation of a muscle using vibration may lead to positive effects on the neuromuscular function. Thus, the aim of the current study is to assess if the addition of local vibration training sessions on the quadriceps muscle to the classic readaptation program (i.e. physiotherapist sessions) may allow a better recuperation 2 months after the surgery and the reconstruction of the anterior cruciate ligament.

The aim of the vibration training proposed in the current study is to allow a better recuperation 2 months after the anterior cruciate ligament reconstruction when compared with conventional physiotherapy alone.

design_allocation: Randomized

ReferenceCitation: Coulondre C, Souron R, Rambaud A, Dalmais É, Espeit L, Neri T, Pinaroli A, Estour G, Millet GY, Rupp T, Feasson L, Edouard P, Lapole T. Local vibration training improves the recovery of quadriceps strength in early rehabilitation after anterior cruciate ligament reconstruction: A feasibility randomised controlled trial. Ann Phys Rehabil Med. 2021 Nov 13;65(4):101441. doi: 10.1016/j.rehab.2020.08.005. [Epub ahead of print]

family: Coulondre

full_name: Claire Coulondre

given: Claire

family: Souron

full_name: Robin Souron

given: Robin

family: Rambaud

full_name: Alexandre Rambaud

given: Alexandre

family: Dalmais

full_name: Étienne Dalmais

given: Étienne

family: Espeit

full_name: Loïc Espeit

given: Loïc

family: Neri

full_name: Thomas Neri

family: Pinaroli

full_name: Alban Pinaroli

given: Alban

family: Estour

full_name: Gilles Estour

given: Gilles

family: Millet

full_name: Guillaume Y. Millet

given: Guillaume Y.

family: Rupp

full_name: Thomas Rupp

family: Feasson

full_name: Léonard Feasson

given: Léonard

family: Edouard

full_name: Pascal Edouard

given: Pascal

family: Lapole

full_name: Thomas Lapole

journal_name: Annals of Physical and Rehabilitation Medicine

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU de SAINT-ETIENNE
CEPART


title: Determination of the Prevalence of ESBL-producing Enterobacteriaceae as Carbapenem-resistant Enterobacteriaceae in Nursing Homes in Franche-Comté (France).

acronym: R'EHPAD

summary: This study evaluates individual and collective factors of ESBL and CRE carriage in nursing homes.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

intervention_type: Diagnostic Test


title: Confocal Laser Endomicroscopy in the Digestive Tract: A Multicentre French Pilot Study.

summary: Confocal laser endomicroscopy (CLE) is a new diagnostic technique that allows microscopic examination of the digestive mucosa during ongoing endoscopy. Different types of tissue and diseases can be diagnosed immediately, and analysis of the in vivo microarchitecture is helpful to better target standard biopsies and reduce the number of biopsies required. CLE necessitates an intravenous injection of a fluorescent marker, e.g. fluorescein, to obtain 'optical biopsies' with a high level of magnification (up to 1000 fold). To date, more than 1000 endomicroscopy procedures have been performed in the world and different publications have shown the safety, feasibility and excellent diagnostic yield of CLE. No complication related to IV injection of fluorescein has been reported. However, all these data come from a very limited number of expert centres and need to be confirmed and validated at the multicenter level. The aims of this multicenter trial are: 1) to standardize CLE in all centres equipped in France, 2) to ensure the safety of intravenous fluorescein injection, 3) to test the diagnostic value of CLE in various conditions representative of the large spectrum of different cancerous and non-cancerous digestive diseases.

lead_sponsor: Nantes University Hospital

location_facility: Service d'Hépato-Gastroentérologie, Centre Hospitalier Lyon Sud

location_facility: Service d'Hépato-Gastroentérologie, Institut Paoli Calmettes

location_facility: Service d'Hépato-Gastroentérologie, CHU Nantes

location_facility: Service d' hépato-gastro-entérologie, CHU de ROUEN


title: Parasympathetic Activity Evaluation by Newborn Infant Parasympathetic Evaluation (NIPE) Monitor (MDMSTM, Loos, France) During Routine General Anesthesia in Children

acronym: OMNIPED

summary: Description of the standard values and fluctuations of the new NIPE index during routine pediatric anesthesia. NIPE monitor connected to anesthesia monitor, displays an instantaneous value ranging from 0 to 100. NIPE values described at different time points during anesthesia: beginning of induction, intubation, extubation, skin incision, opioid administration, vasopressors or atropine administration, transfusion, volume expansion. In addition, NIPE values during hemodynamic events (heart rate or blood pressure increase greater than 20%) will be recorded.

lead_sponsor: University Hospital, Lille


title: PREhospital Routage of Acute STroke Patients With Suspected Large Vessel Occlusion: Mothership Versus Drip and Ship, a Randomized Control Study in France (PRESTO-F)

acronym: PRESTO-F

summary:
Background: The outcome of ischemic stroke is related to the brain lesion volume and this volume of infarction is directly related to the time to reperfusion, which therefore depends on the time to initiation of therapy. Acute ischemic stroke is treated medically with the administration of intravenous rtPA, but recent randomized controlled trials have shown the efficacy of mechanical thrombectomy and is now the new gold standard in ischemic stroke. This new therapeutic strategy has created two possibilities for pre-hospital decision-making: i/ transport the patient directly to the nearest stroke unit to receive alteplase and then if indicated perform a thrombectomy (drip and ship) or ii/ bypassing thrombolysis centres in favour of endovascular thrombectomy (mothership).

Objective: To compare cost/effectiveness of transfer to the closest local stroke centre or telemedicine hub to direct transfer to the comprehensive stroke cent(CSC) in patients acute stroke with suspected large vessel occlusion.

Medical and economic expected impact: We hypothesize that direct transportation to CSC is associated with better clinical outcome in case of acute ischaemic stroke due to intracranial large vessel occlusion. However, we have to demonstrate that this approach is not associated with time from onset harm in patients not eligible to mechanical thrombectomy.

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Caen


title: Rôle de la SMA Dans la préparation Des Mouvements Uni et Bi-manuels: le Paradigme Des Mouvements en Miroir

summary:
The aim of the project is to study the role of secondary motor area (more precisely the supplementary motor area, or SMA) during unimanual and bimanual voluntary movements externally (cue) or internally (subject's choice) triggered. In that view, we will study 3 experimental groups :

a group of healthy volunteers (control group)
the same group of healthy volunteers after a transient inactivation of the SMA (by the aim of repetitive trans cranial magnetic stimulation or TMS)
a group of patients suffering from congenital mirror movements who are suspected to present a dysfunction of the SMA (according to our previous results) In each of these groups, by the aim of a serial reaction time task, we will study the influence of a SMA stimulation on the excitability of the primary motor cortex (M1) during the preparation of a voluntary movement (unimanual or bimanual). This will allow us to assess the communication between the SMA and M1 during movement preparation. Using the same task in functional imagery, we will study the activation's pattern of primary and secondary motor areas during movement preparation. This multimodal approach should allow us to better understand the synergistic functioning of these different structures involved in movement preparation. An other interesting aspect will be to determine the role of these structures in movement lateralization. Eventually, our results might allow us to precise to role of the motor preparation's dysfunction in the genesis of congenital mirror movements.

In the first place, this study aims at a better understanding of the cerebral physiology of movement preparation (which is not well known) using the mirror movements paradigm as a dysfunction model (according to our previous results). According to our hypothesis, there is a strong link between the SMA and M1 during movement preparation. This hypothesis will be assessed by the use of the same experimental task with combined neurophysiological and neuroimaging approaches, thus increasing the validity of the results obtained.

A secondary aim of this protocol is to precise the role of motor planning dysfunction in patients with congenital mirror movements. A better understanding of the mechanisms responsible for this condition is necessary in a medium-term therapeutic prospect.

primary_purpose: Basic Science

lead_sponsor: Institut National de la Santé Et de la Recherche Médicale, France

location_facility: Fédération des Maladies du Système Nerveux, Hôpital Pitié Salpétrière Paris, France 75013


title: Cryotherapy Under Interventional Radiology Combined With in Situ Ipilimumab and a Flat Dose of Nivolumab in Stage IIIB/C Melanoma. Prospective Proof of Concept Study.

acronym: CRIRIN

summary:
Melanoma is the deadliest form of skin cancer and its incidence has doubled every 20 years in France, where this cancer is responsible of more than 1600 deaths each year.

Patients with early diagnosis have good prognosis and can be generally cured by surgery only. Advanced melanoma however has a very bad prognosis.

Loco-regional lymph nodes are usually the first distant localization in metastatic melanoma. Lymph node dissection is then the recommended treatment, although it's impact on survival has never been proven.

In the same way, the benefit risk profile of interferon as adjuvant treatment after lymph node dissection is still much debated.

Recently, new treatments either with immunotherapy (ipilimumab, nivolumab) or by the targeted therapy dabrafenib/trametinib in patients with BRAF mutation have shown an impact on survival in the adjuvant setting after lymph node dissection.

But, it has not yet been established if this strategy has a benefit gain compared to starting those treatments only in the metastatic setting after watchful follow-up.

Moreover, if these novel therapies (targeted therapies: TT, immunotherapies : IT) demonstrated for the first time a real benefit in terms of survival or of responses rates in melanoma, physicians and patients had to address new problems, such as the management of unusual adverse events.

Partial and dissociated responses can also be seen with those new treatments. Some patients will have complete response in some lesions, stabilization in others and progression in a few. It is to be expected that one of the real key points of this therapy is to be found here, as this situation is commonly seen, and it would probably be a poor choice to stop a treatment that is globally effective for progression of only 1 or 2 lesions, in a patient otherwise stabilized.

That is the context in which interventional radiology (IR) should be considered as an extremely efficient option. IR is a real medical revolution in the last 2 decades.

It provides not only the opportunity to determine the characteristics of residual lesion (fibrosis, necrosis, metastasis, or sarcoidosis,…) by biopsy, but allows also their targeted destruction through different technics (cryotherapy, radiofrequency, laser,…).

The investigators are fortunate to have in their institution one of the best IR department of the world (headed by Prof. Afshin GANGI), with a technical platform unique in Europe that allows IR through ultrasound, scan, petscan and MRI.

To the best of their knowledge, Immunotherapy associated with IR has not been performed so far.

This association could in theory:

Combine immunotherapy with tumoral necrosis, which inherently increases the effects of immunotherapy by massive tumoral leakage of danger signals and tumoral antigens;
Allow direct injection in targeted zones, where the beneficial effect is desired, and thus increase the expected immune response;
Reduce side effects related to immunotherapy, by reducing quantities injected; which seems particularly important in the (neo)-adjuvant setting.

That's why the investigators are willing to conduct this pilot project, the objectives of which are:

Providing a proof of the feasibility of this association,
Obtaining preliminary insights on the effects on non-targeted lesions,
Adding a translational research to establish the effect on tumor antigenic expression and the immune response.

status: Active, not recruiting

primary_purpose: Other

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Clinique Dermatologique/Radiologie Interventionnelle/Urologie/Gynécologie-Hôpitaux Universitaires de Strasbourg


title: The Influence of Age on Bispectral Index Associated With Propofol-induced Sedation

summary:
The bispectral index (BIS) is commonly used in anesthesia to evaluate the depth of sedation. Numerous studies in adults have shown good correlation between bispectral index values and depth of sedation regardless of the hypnotic drug used. Requirements of intravenous and inhalational hypnotic agents to suppress consciousness decrease with age. A study showed that the loss of consciousness (LOC) was obtained with lower concentrations of sevoflurane in elderly than in young adults, but at identical BIS values, so that BIS would predict depth of sedation better than drug monitoring. This result incited the use of bispectral index monitoring to overcome the significant pharmacological variability, especially in elderly. Nevertheless, another research with a comparable methodology during propofol-induced anaesthesia provided higher BIS values at LOC in elderly compared to younger patients. In these two trials, LOC was defined differently: either by absence of verbal response corresponding to loss of eyelash reflex (LOER) or by absence of response to prodding [(OAA/S) <2)]. Otherwise electromyographic activity (EMG) was not taken in account. As high EMG level (greater than 50 decibels) could create subtle artifact signal pollution without necessarily being displayed as artifacts, this would be misinterpreted by the BIS algorithm as EEG activity and assigned a spuriously increased BIS value.

The main objective of our study was to specifically evaluate BIS values according to age during propofol-induced sedation. LOC was measured by obtaining an OAA/S score <2 (OAA/S2), or a deeper sedation criterion: loss of eyelash reflex (LOER). The secondary objective was to specify the influence of EMG on the displayed BIS values and its age-related modifications.

primary_purpose: Screening


title: Evaluation à Six Mois du système de dénervation rénale Chez Les Patients Atteints d'Insuffisance Cardiaque

acronym: DENRENIC

summary:
Management of chronic heart failure (CHF) is a major public health problem. It is associated with high mortality, frequent hospitalization and represents a large cost to the health care system. Both pharmacological and non-pharmacological intervention haven't shown to be effective in reducing morbidity and mortality of these patients when able to modulate the activity of neuro-hormonal systems among them the sympathetic nervous system. Recent data have emphasized the potential role of sympathetic renal denervation in patient with hypertension. CHF per se but even more CHF associated with comorbity lead to significant increase level of sympathetic tone. This is largely induced by autonomic dysfunction such as chemo or baroflex abnormalities. These patients usually suffer from conditions which do not allow upgrading and adapting drugs to their sympathetic condition. Hence CHF patient with chronic kidney disease, anemia or both have markedly high sympathetic activity and cannot be exposed to higher level of RAS Blockers or beta blocker due to their renal dysfunction, they thus remain with an elevated sympathetic activity worsening symptoms and prognosis. Chronic heart failure affects around 100 million people worldwild imposing a significant burden on health care system throughout the world. Even though symptoms are improved by heart failure therapy, they remain significantly disabling for many patients. Chronic over activation of the sympathetic nervous system is a major component of heart failure and involves efferent and afferent pathways between brain and many organs. A new therapy directly targeting nerve traffic-renal artery denervation- has been shown to be effective in drug resistant hypertension, with an average drop in blood pressure of 33/12 mm hg.

The cardiologists team of the private hospital Arnault Tzanck is willing therefore to conduct a study in 12 patients with chronic systolic heart failure undergoing bilateral renal denervation with an intensive protocol of observation and assessment compring a 3 day hospital stay post procedure 3 and 6 months of regular outpatient follow-up.

lead_sponsor: Institute Arnault Tzanck, France


title: Circulating and Pulmonary Microparticles for Early Diagnosis of Bronchiolitis Obliterans Syndrome After Lung Transplantation

acronym: MIBO

summary:
The main long-term complication of lung transplantation is chronic lung allograft dysfunction (CLAD). Bronchiolitis obliterans syndrome (BOS) is the most frequent presentation of CLAD. BOS leads to a progressive loss of lung allograft function, with recurrence of dyspnea and airflow limitation. In some advanced cases, patients need a lung re transplantation. The mechanisms of BOS are not completely elucidated, and there are no early markers or specific treatment available for this condition.

Microparticles (MPs) are submicron plasma membrane fragments released into the vascular compartment or the pericellular space in response to cell activation, injury or apoptosis. Broncho alveolar and circulating MPs may reflect cellular insults of the lung allografts. Therefore, MPs could be viewed either as biomarkers or as effectors of the chronic inflammatory or procoagulant processes leading to bronchiolitis obliterans syndrome.

The investigators plan to include 60 patients before lung transplantation at our centre in Strasbourg (France). Follow-up will be requested at the base of usual care (spirometry, blood sampling, bronchoscopy with broncho-alveolar lavage [BAL]). The investigators will measure at one month, one, two and three year post transplantation, the total concentration of MPs in plasma and BAL and characterize their phenotype.

The investigators objective is to demonstrate correlation between total MPs concentration in broncho-alveolar lavage fluid (BALF) and the occurrence of bronchiolitis obliterans syndrome at three years post lung transplantation.


title: Cost-effectiveness Analysis Associated With the Use of Resorbable Biosynthetic Parietal Prostheses Compared to Biological Prostheses in Contaminated (mVHWG Grade 3) Abdominal Wall Reconstruction

summary:
Eventration corresponds to the dehiscence of the abdominal wall, with passage of peritoneum and / or intra-abdominal viscera, through an acquired orifice of the abdominal wall. It is secondary to an old incision and occurs in 10 to 20% of cases after a laparotomy. At present, if there is no debate on the type of prosthesis to implant in case of clean surgery: it is a synthetic prosthesis. But in the case of contaminated surgery (modified Ventral Hernia Working Group grade 3), there is no consensus.

Since the 1990s, biological prostheses have been recommended, but they represent significant expenses for health facilities. They are very numerous, and their prices vary between 3 000 € and 12 000 €. The choice is therefore difficult for the surgeon.

In 2016 the Strasbourg University Hospital general surgery team made the choice to use biosynthetic prostheses. This attitude does not seem consensual and is not based on any recommendations at present, either in France or internationally. The homogenization of practices requires the availability of clinical and medico-economic data, particularly in view of the price differences that exist between different types of prostheses.

The main objective of this study will be to compare the use of biosynthetic prostheses with biological prostheses in the treatment of curative surgical treatment of mVHWG grade 3 incisional hernias in terms of cost and serious complications at 6 months.

The secondary objective of the study will be to estimate the number of early recurrences at 6 months avoided, thanks to the use of biosynthetic prostheses compared to biological prostheses.

location_facility: Service de Chirurgie générale et digestive


title: Staphylococcal Acute Post-Operative Prosthetic Joint Infection Treated With 'DAIR' (Debridement and Implant Retention) And Impact Of Rifampin: A Retrospective Cohort Study In France

acronym: IPASTAPH

summary: S. aureus and coagulase-negative staphylococci are the most frequent bacteria responsible for PJI (prosthetic joint infection). The aim of this study is to describe the use of rifampicin.

lead_sponsor: Hospices Civils de Lyon


title: Heart Rate, Baroreflex Sensitivity and Cardiovascular Morbidity and Mortality in the Population. The Paris Prospective Study III

acronym: PPSIII

summary: The aim of the present PPS3 study is (1) to assess the determinants of the regulation of heart rate and blood pressure variations and carotid properties (under different physiologic stimulations) and (2) to evaluate the respective contribution of heart rate, blood pressure variations and carotid properties to cardiovascular morbidity and mortality including sudden death during 10 years at least in healthy considered subjects.

ReferenceCitation: Jouven X, Empana JP, Schwartz PJ, Desnos M, Courbon D, Ducimetière P. Heart-rate profile during exercise as a predictor of sudden death. N Engl J Med. 2005 May 12;352(19):1951-8.

ReferenceCitation: Jouven X, Zureik M, Desnos M, Courbon D, Ducimetière P. Long-term outcome in asymptomatic men with exercise-induced premature ventricular depolarizations. N Engl J Med. 2000 Sep 21;343(12):826-33.

ReferenceCitation: Briet M, Bozec E, Laurent S, Fassot C, London GM, Jacquot C, Froissart M, Houillier P, Boutouyrie P. Arterial stiffness and enlargement in mild-to-moderate chronic kidney disease. Kidney Int. 2006 Jan;69(2):350-7.

ReferenceCitation: Kornet L, Hoeks AP, Janssen BJ, Houben AJ, De Leeuw PW, Reneman RS. Neural activity of the cardiac baroreflex decreases with age in normotensive and hypertensive subjects. J Hypertens. 2005 Apr;23(4):815-23.

ReferenceCitation: Empana JP, Sykes DH, Luc G, Juhan-Vague I, Arveiler D, Ferrieres J, Amouyel P, Bingham A, Montaye M, Ruidavets JB, Haas B, Evans A, Jouven X, Ducimetiere P; PRIME Study Group. Contributions of depressive mood and circulating inflammatory markers to coronary heart disease in healthy European men: the Prospective Epidemiological Study of Myocardial Infarction (PRIME). Circulation. 2005 May 10;111(18):2299-305. Epub 2005 May 2.

ReferenceCitation: Lisan Q, Tafflet M, Charles MA, Thomas F, Boutouyrie P, Guibout C, Haba-Rubio J, Périer MC, Pannier B, Marques-Vidal P, Jouven X, Empana JP. Self-reported body silhouette trajectories across the lifespan and excessive daytime sleepiness in adulthood: a retrospective analysis. The Paris Prospective Study III. BMJ Open. 2018 Mar 27;8(3):e020851. doi: 10.1136/bmjopen-2017-020851.

family: Lisan

full_name: Quentin Lisan

given: Quentin

family: Tafflet

full_name: Muriel Tafflet

given: Muriel

family: Charles

full_name: Marie-Aline Charles

given: Marie-Aline

family: Thomas

full_name: Frédérique Thomas

given: Frédérique

family: Boutouyrie

full_name: Pierre Boutouyrie

given: Pierre

family: Guibout

full_name: Catherine Guibout

given: Catherine

family: Haba-Rubio

full_name: José Haba-Rubio

given: José

family: Périer

full_name: Marie Cécile Périer

given: Marie Cécile

family: Pannier

full_name: Bruno Pannier

given: Bruno

family: Marques-Vidal

full_name: Pedro Marques-Vidal

given: Pedro

family: Jouven

full_name: Xavier Jouven

given: Xavier

family: Empana

full_name: Jean-Philippe Empana

given: Jean-Philippe

journal_name: BMJ Open

repository_institution: Université de Lausanne - SERVAL

repositories_institution:
PubMed Central - Europe PMC
Université de Lausanne - SERVAL

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Simon M, Boutouyrie P, Narayanan K, Gaye B, Tafflet M, Thomas F, Guibout C, Périer MC, Pannier B, Jouven X, Empana JP. Sex disparities in ideal cardiovascular health. Heart. 2017 Oct;103(20):1595-1601. doi: 10.1136/heartjnl-2017-311311. Epub 2017 Jul 28.

family: Simon

full_name: Marie Simon

ReferenceCitation: Empana JP, Perier MC, Singh-Manoux A, Gaye B, Thomas F, Prugger C, Plichart M, Wiernik E, Guibout C, Lemogne C, Pannier B, Boutouyrie P, Jouven X. Cross-sectional analysis of deprivation and ideal cardiovascular health in the Paris Prospective Study 3. Heart. 2016 Dec 1;102(23):1890-1897. doi: 10.1136/heartjnl-2016-309502. Epub 2016 Jun 27.

location_facility: Investigations Pré cliniques et Preventives de Paris


title: A Randomized Trial of Deferred Versus Fresh Embryo Transfers in Infertile Women Undergoing IVF-ICSI

acronym: DEFETOSE

summary: Controlled ovarian stimulation (COS) enhances the efficacy of ART (Assisted reproductive technology) by permitting multiple-oocyte yields, but also alters endometrial receptivity (ER) by an advancement of endometrial development which contributes to diminished pregnancy chances. Previous reports suggest that pregnancy rates are increased following deferred frozen embryo transfers. In addition as compared to fresh embryo transfers, frozen embryo transfers seem to be associated with less affected perinatal outcomes, in particular lower risk of preterm birth, small for gestational age and caesarean section. Unfortunately, most of the current evidence is based only on preliminary reports, needing further scientific evidence. Thus, whether differing embryo transfers could restore optimal ER leading to higher live birth rate (LBR) and better obstetrical outcomes as compared to fresh embryo transfers, is actually still under investigation.

ReferenceCitation: Zaat T, Zagers M, Mol F, Goddijn M, van Wely M, Mastenbroek S. Fresh versus frozen embryo transfers in assisted reproduction. Cochrane Database Syst Rev. 2021 Feb 4;2:CD011184. doi: 10.1002/14651858.CD011184.pub3.

name: Amsterdam UMC, University of Amsterdam; Center for Reproductive Medicine, Amsterdam Reproduction & Development Research Institute; Amsterdam Netherlands

family: Zaat

full_name: Tjitske Zaat

given: Tjitske

family: Zagers

full_name: Miriam Zagers

given: Miriam

family: Mol

full_name: Femke Mol

given: Femke

family: Goddijn

full_name: Mariëtte Goddijn

given: Mariëtte

family: van Wely

full_name: Madelon van Wely

given: Madelon

family: Mastenbroek

full_name: Sebastiaan Mastenbroek

given: Sebastiaan

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Assistance Publique - Hôpitaux de Paris


type: U.S. NIH Grant/Contract

title: Parkin Mutations and Their Functional Consequences

summary:
Parkinson's disease (PD) is the most frequent neurodegenerative disease with a prevalence of 2% over 65 years and because of this high prevalence as the population ages, it is a major problem of public health.

An exhaustive repertory of not only parkin mutations in autosomal recessive forms of PD but also in other known genes such as DJ-1, PINK1 and LRRK2, is of major importance for both genetic counseling in families affected with PD and physiopathological approaches to this disease.

Through a French network for the study of Parkinson's disease genetics and extended collaborations with European, Mediterranean and other various countries, a total of 2934 subjects including 1683 patients and 1251 unaffected individuals has been collected since 2002. These samples consisted of 122 families with autosomal recessive PD, 285 cases of isolated early onset PD, 110 autosomal recessive and 129 autosomal dominant families with late onset PD, 201 isolated late onset PD cases and 250 matched controls.

DNAs from all subjects are now available, lymphocytes and lymphoblastoid cell lines have been stored for most patients from France and recently, fresh fibroblasts have been obtained for some individuals.

The genetic approach to autosomal recessive PD is focused on the identification of mutations in the parkin gene but also on the screening of DJ-1, PINK1 and LRRK2 genes.

ReferenceCitation: Rawal N, Periquet M, Lohmann E, Lücking CB, Teive HA, Ambrosio G, Raskin S, Lincoln S, Hattori N, Guimaraes J, Horstink MW, Dos Santos Bele W, Brousolle E, Destée A, Mizuno Y, Farrer M, Deleuze JF, De Michele G, Agid Y, Dürr A, Brice A; French Parkinson's Disease Genetics Study Group; European Consortium on Genetic Susceptibility in Parkinson's Disease. New parkin mutations and atypical phenotypes in families with autosomal recessive parkinsonism. Neurology. 2003 Apr 22;60(8):1378-81.

ReferenceCitation: Periquet M, Latouche M, Lohmann E, Rawal N, De Michele G, Ricard S, Teive H, Fraix V, Vidailhet M, Nicholl D, Barone P, Wood NW, Raskin S, Deleuze JF, Agid Y, Dürr A, Brice A; French Parkinson's Disease Genetics Study Group; European Consortium on Genetic Susceptibility in Parkinson's Disease. Parkin mutations are frequent in patients with isolated early-onset parkinsonism. Brain. 2003 Jun;126(Pt 6):1271-8.

ReferenceCitation: Ibáñez P, Lohmann E, Pollak P, Durif F, Tranchant C, Agid Y, Dürr A, Brice A; French Parkinson's Disease Genetics Study Group. Absence of NR4A2 exon 1 mutations in 108 families with autosomal dominant Parkinson disease. Neurology. 2004 Jun 8;62(11):2133-4.

ReferenceCitation: Ibáñez P, De Michele G, Bonifati V, Lohmann E, Thobois S, Pollak P, Agid Y, Heutink P, Dürr A, Brice A; French Parkinson's Disease Genetics Study Group. Screening for DJ-1 mutations in early onset autosomal recessive parkinsonism. Neurology. 2003 Nov 25;61(10):1429-31.

ReferenceCitation: Lücking CB, Chesneau V, Lohmann E, Verpillat P, Dulac C, Bonnet AM, Gasparini F, Agid Y, Dürr A, Brice A. Coding polymorphisms in the parkin gene and susceptibility to Parkinson disease. Arch Neurol. 2003 Sep;60(9):1253-6.

ReferenceCitation: Lohmann E, Periquet M, Bonifati V, Wood NW, De Michele G, Bonnet AM, Fraix V, Broussolle E, Horstink MW, Vidailhet M, Verpillat P, Gasser T, Nicholl D, Teive H, Raskin S, Rascol O, Destée A, Ruberg M, Gasparini F, Meco G, Agid Y, Durr A, Brice A; French Parkinson's Disease Genetics Study Group; European Consortium on Genetic Susceptibility in Parkinson's Disease. How much phenotypic variation can be attributed to parkin genotype? Ann Neurol. 2003 Aug;54(2):176-85.

ReferenceCitation: Lesage S, Dürr A, Tazir M, Lohmann E, Leutenegger AL, Janin S, Pollak P, Brice A; French Parkinson's Disease Genetics Study Group. LRRK2 G2019S as a cause of Parkinson's disease in North African Arabs. N Engl J Med. 2006 Jan 26;354(4):422-3.

ReferenceCitation: Ibáñez P, Lesage S, Lohmann E, Thobois S, De Michele G, Borg M, Agid Y, Dürr A, Brice A; French Parkinson's Disease Genetics Study Group. Mutational analysis of the PINK1 gene in early-onset parkinsonism in Europe and North Africa. Brain. 2006 Mar;129(Pt 3):686-94. Epub 2006 Jan 9.

ReferenceCitation: Lesage S, Janin S, Lohmann E, Leutenegger AL, Leclere L, Viallet F, Pollak P, Durif F, Thobois S, Layet V, Vidailhet M, Agid Y, Dürr A, Brice A; French Parkinson's Disease Genetics Study Group, Bonnet AM, Borg M, Broussolle E, Damier P, Destée A, Martinez M, Penet C, Rasco O, Tison F, Tranchan C, Vérin M. LRRK2 exon 41 mutations in sporadic Parkinson disease in Europeans. Arch Neurol. 2007 Mar;64(3):425-30.

ReferenceCitation: Leutenegger AL, Salih MA, Ibáñez P, Mukhtar MM, Lesage S, Arabi A, Lohmann E, Dürr A, Ahmed AE, Brice A. Juvenile-onset Parkinsonism as a result of the first mutation in the adenosine triphosphate orientation domain of PINK1. Arch Neurol. 2006 Sep;63(9):1257-61.

ReferenceCitation: Lesage S, Magali P, Lohmann E, Lacomblez L, Teive H, Janin S, Cousin PY, Dürr A, Brice A; French Parkinson Disease Genetics Study Group. Deletion of the parkin and PACRG gene promoter in early-onset parkinsonism. Hum Mutat. 2007 Jan;28(1):27-32.

ReferenceCitation: Brice A, Lohmann E, Ibanez P, Periquet M, Laine S, Debarges B, Lesage S, Dürr A. Phenotype/genotype correlations in Parkinson's disease. In: Relationships in Neurodegenerative Diseases, Cummings, Hardy, Poncet and Christen (Eds), Springer-Verlag Berlin Heidelberg Eds, 153-64, 2005.

ReferenceCitation: Lohmann E, Dürr A, Ruberg M, Brice A. Parkin. In: Parkinson's Disease: Genetic and Pathogenesis, Dawson Eds, in press, 2006.

ReferenceCitation: Brice A. [What can we learn from genes responsible for familial forms of Parkinson's disease?]. Bull Acad Natl Med. 2006 Feb;190(2):485-96; discussion 497-8. Review. French.

ReferenceCitation: Ishihara L, Warren L, Gibson R, Amouri R, Lesage S, Dürr A, Tazir M, Wszolek ZK, Uitti RJ, Nichols WC, Griffith A, Hattori N, Leppert D, Watts R, Zabetian CP, Foroud TM, Farrer MJ, Brice A, Middleton L, Hentati F. Clinical features of Parkinson disease patients with homozygous leucine-rich repeat kinase 2 G2019S mutations. Arch Neurol. 2006 Sep;63(9):1250-4.

ReferenceCitation: Foroud T, Pankratz N, Martinez M; PROGENI/GSPD-European Consortium. Chromosome 5 and Parkinson disease. Eur J Hum Genet. 2006 Oct;14(10):1106-10. Epub 2006 May 31.


title: Oral Manifestations of Systemic Sclerosis: Toward the Identification of New Prognostic Markers

summary:
Systemic sclerosis (SSc) is a rare multisystem connective-tissue disorder characterized by three major pathological hallmarks: widespread fibrosis, vasculopathy and immunological abnormalities. As all connective tissues can be affected, this condition has multiple effects on the orofacial region. Indeed, the latter is involved in approximately 80% of SSc patients. Oral manifestations have a major impact on quality of life and require specific treatments that should be performed as early as possible.

Widening of the periodontal ligament space, that seems to be linked to an increased collagen synthesis, is one of the most common dental radiographic finding. However, this radiologic sign has been mostly studied on two-dimensional radiographs. The investigators have recently described in a patient suffering from SSc the existence of calcifications within the periodontal ligament space using Cone Beam Computed Tomography (CBCT) approach (Jung et al., Oral Surg Oral Med Oral Pathol Oral Radiol 2013). Such calcifications, that have never been observed before, could be part of the phenotypic spectrum of the disease, in particular when dystrophic calcinosis is associated. They could furthermore constitute a specific feature of SSc. However, this radiographic sign requires to be investigated in a largest number of patients.

Several cytokines have been implicated in SSc pathogenesis. A recent study has revealed that elevated CXCL4 serum levels correlate with disease complications, suggesting that this molecule could be used as a prognostic biomarker. Increased IL-6 serum levels also correlate with SSc severity. Gingival crevicular fluid can be easily collected from the gingival crevice surrounding the teeth and constitute an indicator of local but also systemic inflammation. Analysis of gingival crevicular fluid cytokine profile could contribute to the identification of specific SSc biomarkers and allow a better comprehension of oral manifestations pathogenesis.

The aim of this case-control study is to characterize precisely the oral manifestations associated with SSc within the National Referral Center for Rare Autoimmune Diseases (Strasbourg, France) patient cohort in order to identify specific radiological, clinical and/or biological signs. Some of them could be correlated to the severity or to the prognosis of the disease. To the investigators knowledge it is the first study using tridimensional CBCT approach.

intervention_type: Radiation


title: Utility of Quantitative Polymerase Chain Reaction to Predict Clinical Outcome of Leptospirosis in French West Indies

acronym: LEPTO

summary:
Leptospirosis is a zoonosis of worldwide distribution whose incidence is higher in the tropics, where conditions for transmissions are favorable. The disease is endemic in Martinique and Guadeloupe, two Caribbean islands of the French West Indies. In tropical areas, many wild and domestic animals serve as reservoirs for pathogenic Leptospira strains and contaminate the environment by shedding the organisms in their urine. Humans are usually infected through abraded skin or mucous membrane contact with water contaminated by the urine of animal reservoirs, and less frequently by direct contact with animals or their urine. The mean incubation period is 10 days, with a usual range of 2-20 days. Clinical manifestations are protean and the spectrum of symptoms range from subclinical or mild anicteric febrile illness to acute renal failure and respiratory distress syndrome which are associated with high mortality rates.

The microscopic agglutination test (MAT) and culture are the reference standard test for diagnosis of leptospirosis, but they are only available in reference laboratories and their conclusive results requires convalescent sample or prolonged incubation. At present, only direct detection methods using PCR might provide rapid diagnosis during the early acute stage of the illness, when treatment is likely to have the greatest benefit.

Quantitative PCR also offers the ability to measure level of leptospiremia in clinical samples. Using qPCR based diagnosis, the investigators have the opportunity to study the association of level of leptospiremia and clinical manifestations in French West Indies. All qPCR-positive samples will be used for molecular typing.

lead_sponsor: University Hospital Center of Martinique

location_facility:
CHU Pointe-à-Pitre Abymes
CHU Martinique


title: Efficacy Assessment of Early Osteopathic Manipulative Treatment (OMT) in the Management of Suboptimal Breastfeeding Behaviour in Healthy Newborns. A Prospective Monocentric Randomized Double-blinded Study.

acronym: NEOSTEO

summary:
Breastfeeding is one of the prime factors of long-term health protection in newborns, for nutritional, immunological and developmental reasons. In France there is a wide inter-regional variability of breastfeeding rates at discharge. This variability associates different factors involving both, mothers, birth conditions, newborns and mother-child couple. Some approaches, including osteopathy, aim to support early breastfeeding difficulties. As many others non-conventional medicines, there is a huge and growing interest for this alternative therapy and a spontaneous recourse in the first months of life. Nevertheless, neither efficacy nor the benefits have been studied. Thus, our objective is to evaluate for the first time in France, in a randomized, double-blinded design, the efficacy of early osteopathic manipulative treatment (OMT), in suboptimal breastfeeding behaviour healthy newborns.

128 couples mother-child will be randomized in two groups: with or without osteopathic intervention on the newborn.

ReferenceCitation: Danielo Jouhier M, Boscher C, Roze JC, Cailleau N, Chaligne F, Legrand A, Flamant C, Muller JB; NEOSTEO osteopath study group. Osteopathic manipulative treatment to improve exclusive breast feeding at 1 month. Arch Dis Child Fetal Neonatal Ed. 2021 Nov;106(6):591-595. doi: 10.1136/archdischild-2020-319219. Epub 2021 Mar 31.

family: Danielo Jouhier

full_name: Marie Danielo Jouhier

given: Marie

family: Boscher

full_name: Cécile Boscher

given: Cécile

family: Roze

full_name: Jean-Christophe Roze

given: Jean-Christophe

family: Cailleau

full_name: Nicolas Cailleau

given: Nicolas

family: Chaligne

full_name: Frédéric Chaligne

given: Frédéric

family: Legrand

full_name: Arnaud Legrand

given: Arnaud

family: Flamant

full_name: Cyril Flamant

given: Cyril

family: Muller

full_name: Jean-Baptiste Muller

given: Jean-Baptiste

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

location_facility: Centre Hospitalier Universitaire de Nantes - Hôpital Mère-Enfant