title: French and EuRopean Outcome Registry in Intensive Care Unit

acronym: FROG-ICU

summary: The purpose of this study is to identify within a cohort of ICU patients admitted for severe illness those who are at risk of death in the year following the discharge from ICU.

ReferenceCitation: Mebazaa A, Casadio MC, Azoulay E, Guidet B, Jaber S, Levy B, Payen D, Vicaut E, Resche-Rigon M, Gayat E. Post-ICU discharge and outcome: rationale and methods of the The French and euRopean Outcome reGistry in Intensive Care Units (FROG-ICU) observational study. BMC Anesthesiol. 2015 Oct 12;15:143. doi: 10.1186/s12871-015-0129-2.

family: Mebazaa

full_name: Alexandre Mebazaa

given: Alexandre

family: Casadio

full_name: Maria Chiara Casadio

given: Maria Chiara

family: Azoulay

full_name: Elie Azoulay

given: Elie

family: Guidet

full_name: Bertrand Guidet

family: Jaber

full_name: Samir Jaber

given: Samir

family: Levy

full_name: Bruno Levy

given: Bruno

family: Payen

full_name: Didier Payen

given: Didier

family: Resche-Rigon

full_name: Matthieu Resche-Rigon

given: Matthieu

family: Gayat

full_name: Etienne Gayat

given: Etienne

journal_name: BMC Anesthesiology

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Mines Nantes

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Audencia Business School

ReferenceCitation: Kimmoun A, Cariou A, Gayat E, Feliot E, Takagi K, Megarbane B, Mebazaa A, Deye N; FROG-ICU Study investigators. One-year outcome of patients admitted after cardiac arrest compared to other causes of ICU admission. An ancillary analysis of the observational prospective and multicentric FROG-ICU study. Resuscitation. 2020 Jan 1;146:237-246. doi: 10.1016/j.resuscitation.2019.10.021. Epub 2019 Oct 31.

family: Kimmoun

full_name: Antoine Kimmoun

given: Antoine

family: Cariou

full_name: Alain Cariou

given: Alain

ReferenceCitation: Cinotti R, Voicu S, Jaber S, Chousterman B, Paugam-Burtz C, Oueslati H, Damoisel C, Caillard A, Roquilly A, Feuillet F, Mebazaa A, Gayat E; FROG-ICU investigators. Tracheostomy and long-term mortality in ICU patients undergoing prolonged mechanical ventilation. PLoS One. 2019 Oct 2;14(10):e0220399. doi: 10.1371/journal.pone.0220399. eCollection 2019.

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Ecole polytechnique

ReferenceCitation: Legrand M, Hollinger A, Vieillard-Baron A, Dépret F, Cariou A, Deye N, Fournier MC, Jaber S, Damoisel C, Lu Q, Monnet X, Rennuit I, Darmon M, Zafrani L, Leone M, Guidet B, Friedman D, Sonneville R, Montravers P, Pili-Floury S, Lefrant JY, Duranteau J, Laterre PF, Brechot N, Oueslati H, Cholley B, Launay JM, Ishihara S, Sato N, Mebazaa A, Gayat E; French and euRopean Outcome reGistry in ICUs (FROG-ICU) Investigators. One-Year Prognosis of Kidney Injury at Discharge From the ICU: A Multicenter Observational Study. Crit Care Med. 2019 Dec;47(12):e953-e961. doi: 10.1097/CCM.0000000000004010.

ReferenceCitation: Hollinger A, Gayat E, Féliot E, Paugam-Burtz C, Fournier MC, Duranteau J, Lefrant JY, Leone M, Jaber S, Mebazaa A, Arrigo M; FROG ICU study investigators. Gender and survival of critically ill patients: results from the FROG-ICU study. Ann Intensive Care. 2019 Mar 29;9(1):43. doi: 10.1186/s13613-019-0514-y.

name: On behalf of the FROG ICU study investigators

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université d'Artois

ReferenceCitation: Bastian K, Hollinger A, Mebazaa A, Azoulay E, Féliot E, Chevreul K, Fournier MC, Guidet B, Michel M, Montravers P, Pili-Floury S, Sonneville R, Siegemund M, Gayat E; FROG-ICU Study Investigators. Association of social deprivation with 1-year outcome of ICU survivors: results from the FROG-ICU study. Intensive Care Med. 2018 Dec;44(12):2025-2037. doi: 10.1007/s00134-018-5412-5. Epub 2018 Oct 23.

ReferenceCitation: Gayat E, Hollinger A, Cariou A, Deye N, Vieillard-Baron A, Jaber S, Chousterman BG, Lu Q, Laterre PF, Monnet X, Darmon M, Leone M, Guidet B, Sonneville R, Lefrant JY, Fournier MC, Resche-Rigon M, Mebazaa A, Legrand M; FROG-ICU investigators. Impact of angiotensin-converting enzyme inhibitors or receptor blockers on post-ICU discharge outcome in patients with acute kidney injury. Intensive Care Med. 2018 May;44(5):598-605. doi: 10.1007/s00134-018-5160-6. Epub 2018 May 15.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Jean Moulin Lyon 3

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IN2P3

ReferenceCitation: Gayat E, Cariou A, Deye N, Vieillard-Baron A, Jaber S, Damoisel C, Lu Q, Monnet X, Rennuit I, Azoulay E, Léone M, Oueslati H, Guidet B, Friedman D, Tesnière A, Sonneville R, Montravers P, Pili-Floury S, Lefrant JY, Duranteau J, Laterre PF, Brechot N, Chevreul K, Michel M, Cholley B, Legrand M, Launay JM, Vicaut E, Singer M, Resche-Rigon M, Mebazaa A. Determinants of long-term outcome in ICU survivors: results from the FROG-ICU study. Crit Care. 2018 Jan 18;22(1):8. doi: 10.1186/s13054-017-1922-8.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

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

repository_institution: University College London - UCL Discovery

ReferenceCitation: Legrand M, Januzzi JL Jr, Mebazaa A. Critical research on biomarkers: what's new? Intensive Care Med. 2013 Oct;39(10):1824-8. doi: 10.1007/s00134-013-3008-7. Epub 2013 Jul 5.

title: Critical research on biomarkers: what’s new?

location_facility: Department of Anesthesiology and Intensive Care Unit - Lariboisiere Hospital

location_facility: St Louis hospital, department of intensive care


type: Other Identifier

title: Current Care Study of Incidence and Consequences of Swallowing Disorders After Invasive Mechanical Ventilation

acronym: Deglutube

summary: Epidemiology study for evaluation of incidence of swallowing disorders (SD) after prolonged invasive ventilation (more than seven days), using a clinical statement. All consecutive patients are screened, and clinical evaluation is performed during 48h after patient's extubation. If a SD exist, a new evaluation is realized 48h after. Three groups will be created (1.no SD, 2.transitory SD and 3.persistent SD (eg persistent after 48h)). Data complementary are notified at day 28 (pneumonia? nutritional status?)

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Beduneau G, Souday V, Richard JC, Hamel JF, Carpentier D, Chretien JM, Bouchetemble P, Laccoureye L, Astier A, Tanguy V, Mercat A, Beloncle F, Tamion F. Persistent swallowing disorders after extubation in mechanically ventilated patients in ICU: a two-center prospective study. Ann Intensive Care. 2020 Oct 14;10(1):138. doi: 10.1186/s13613-020-00752-x.

family: Beduneau

full_name: G. Beduneau

given: G.

sequence: first

family: Souday

full_name: V. Souday

given: V.

sequence: additional

family: Richard

full_name: J. C. Richard

given: J. C.

family: Hamel

full_name: J. F. Hamel

given: J. F.

family: Carpentier

full_name: D. Carpentier

given: D.

family: Chretien

full_name: J. M. Chretien

given: J. M.

family: Bouchetemble

full_name: P. Bouchetemble

given: P.

family: Laccoureye

full_name: L. Laccoureye

given: L.

family: Astier

full_name: A. Astier

given: A.

family: Tanguy

full_name: V. Tanguy

family: Mercat

full_name: A. Mercat

family: Beloncle

full_name: F. Beloncle

given: F.

family: Tamion

full_name: F. Tamion

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annals of Intensive Care

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: University Hospital, Rouen

location_facility:
service de Réanimation médicale
Service de Réanimation Médicale

lead_sponsor_type: academique

status_simplified: Completed


title: Trial Evaluating the Efficacy and Tolerance of Perioperative Chemotherapy With 5FU-Cisplatin-Cetuximab in Adenocarcinomas of the Stomach and Gastroesophageal Junction. Phase II Single Arm, Multicenter.

summary:
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, cisplatin, and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving more than one drug (combination chemotherapy) together with cetuximab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these drugs after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying the side effects of giving fluorouracil, cisplatin, and leucovorin calcium together with cetuximab and to see how well they work in treating patients with adenocarcinoma of the stomach or gastroesophageal junction.

study_type: Interventional

primary_purpose: Treatment

ReferenceType: result

ReferenceCitation: Mariette C, Dahan L, Mornex F, Maillard E, Thomas PA, Meunier B, Boige V, Pezet D, Robb WB, Le Brun-Ly V, Bosset JF, Mabrut JY, Triboulet JP, Bedenne L, Seitz JF. Surgery alone versus chemoradiotherapy followed by surgery for stage I and II esophageal cancer: final analysis of randomized controlled phase III trial FFCD 9901. J Clin Oncol. 2014 Aug 10;32(23):2416-22. doi: 10.1200/JCO.2013.53.6532. Epub 2014 Jun 30.

name: Christophe Mariette, William B. Robb, and Jean-Pierre Triboulet, ONCOLille Site de Recherche Intégrée sur le Cancer, Université Lille–Nord de France, and Lille University Hospital; Christophe Mariette, Institut National de la Santé et de la Recherche Médicale, Unités Mixtes de Recherche 837, Jean Pierre Aubert Research Center, Lille; Laetitia Dahan and Jean-François Seitz, La Timone Hospital, Aix-Marseille University; Pascal-Alexandre Thomas, Hôpital Nord, Marseille; Françoise Mornex, Pierre-Bénite...

family: Mariette

full_name: Christophe Mariette

given: Christophe

family: Dahan

full_name: Laetitia Dahan

given: Laetitia

family: Mornex

full_name: Françoise Mornex

given: Françoise

family: Maillard

full_name: Emilie Maillard

given: Emilie

family: Thomas

full_name: Pascal-Alexandre Thomas

given: Pascal-Alexandre

family: Meunier

full_name: Bernard Meunier

given: Bernard

family: Boige

full_name: Valérie Boige

given: Valérie

family: Pezet

full_name: Denis Pezet

given: Denis

family: Robb

full_name: William B. Robb

given: William B.

family: Le Brun-Ly

full_name: Valérie Le Brun-Ly

family: Bosset

full_name: Jean-François Bosset

given: Jean-François

family: Mabrut

full_name: Jean-Yves Mabrut

given: Jean-Yves

family: Triboulet

full_name: Jean-Pierre Triboulet

given: Jean-Pierre

family: Bedenne

full_name: Laurent Bedenne

given: Laurent

family: Seitz

full_name: Jean-François Seitz

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Surgery Alone Versus Chemoradiotherapy Followed by Surgery for Stage I and II Esophageal Cancer: Final Analysis of Randomized Controlled Phase III Trial FFCD 9901

ipd_sharing: No

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: Centre Hospitalier Regional et Universitaire de Lille

intervention_type: Procedure

lead_sponsor_type: industriel


title: Evaluation of the Effect of Pasireotide LAR Administration in the Lymphocele Prevention After Axillary Node Dissection for Breast Cancer

acronym: SOM 230

summary:
The principal morbidity following axillary node dissection within the scope of breast cancer surgery is the post-operative development of lymphocele. According to the literature, incidence can vary from 4 to 89% depending on the type of surgery, whether or not a drain is inserted or a compression dressing applied and the time at which the drain is removed… In our experience, the incidence is 40% [IGR (Gustave Roussy Institute) data focusing on 70 patients between November 2008 and February 2009]

Encouraging results in terms of reducing postoperative lymphoceles as well as drainage duration and volume using Octreotide have been recorded in two recent studies. A new molecule developed by Novartis Laboratories, namely pasireotide, is a somatostatin analog possessing strong affinity for several somatostatin receptors (30 to 40 times greater for sst1 and sst5, 5 times greater for sst3 and equivalent for sst2)

The purpose of this trial is to assess the efficacy of a pre-surgical injection of pasireotide LAR in reducing the postoperative incidence of symptomatic lymphoceles following axillary node dissection.

The secondary objectives are to assess the efficacy of prolonged release pasireotide on the duration of postoperative drainage, the daily drainage volume, the total drainage volume, the number of repeated lymphocele aspirations and the volume, the total volume of lymph aspirated, the incidence of postoperative febrile episodes, the length of hospital stay, and the length of time to onset of adjuvant chemotherapy. It is also to assess the safety of prolonged release pasireotide.

The primary objective of this study is to assess the efficacy of a preoperative prolonged release pasireotide injection in the reduction in the incidence of symptomatic, postoperative axillary lymphoceles following mastectomy-axillary node dissection.

design_allocation: Randomized

primary_purpose: Prevention

ReferenceCitation: Chéreau E, Uzan C, Boutmy-Deslandes E, Zohar S, Bézu C, Mazouni C, Garbay JR, Daraï E, Rouzier R. Evaluation of the Effects of Pasireotide LAR Administration on Lymphocele Prevention after Axillary Node Dissection for Breast Cancer: Results of a Randomized Non-Comparative Phase 2 Study. PLoS One. 2016 Jun 9;11(6):e0156096. doi: 10.1371/journal.pone.0156096. eCollection 2016.

family: Chéreau

full_name: Elisabeth Chéreau

given: Elisabeth

family: Uzan

full_name: Catherine Uzan

given: Catherine

family: Boutmy-Deslandes

full_name: Emmanuelle Boutmy-Deslandes

given: Emmanuelle

family: Zohar

full_name: Sarah Zohar

given: Sarah

family: Bézu

full_name: Corinne Bézu

given: Corinne

family: Mazouni

full_name: Chafika Mazouni

given: Chafika

family: Garbay

full_name: Jean-Rémi Garbay

given: Jean-Rémi

family: Daraï

full_name: Emile Daraï

given: Emile

family: Rouzier

full_name: Roman Rouzier

given: Roman

currency_apc_doaj: USD

journal_name: PLOS ONE

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

repository_institution: PubMed Central - Europe PMC

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - MINES ParisTech

repository_normalized: HAL

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

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

lead_sponsor: Alliance Pour La Recherche en Cancerologie

location_facility:
Institut Gustave ROUSSY
Tenon Hospital

intervention_type: Drug


acronym: PARALYSTIM

summary:
Psychogenic paralysis presents a real treatment challenge. Despite psychotherapy, physiotherapy, antidepressants, acupuncture or hypnosis, the outcome is not always satisfactory with persistent symptoms after long-term follow-up. In a preliminary retrospective study on 70 patients with psychogenic paralysis (44F/26M, mean age : 24.7 ± 16.6 ys), repetitive transcranial magnetic stimulation (rTMS) delivered over the motor cortex at low frequency was effective in 89% of cases (recovery: n=53, improvement: n=9), with an immediate or quasi-immediate recovery in 73% of patients (n=51).

We suggest that the dramatic improvement of psychogenic paralysis after rTMS could be due to the restoration of an appropriate cerebral connectivity by activating a suppressed motor cortex. Nevertheless, the possibility of a placebo effect cannot be ruled out.

A prospective multicentric (Rouen, Caen) randomized controlled trial versus placebo will be done for 94 patients with psychogenic paralysis, 1- to evaluate rTMS efficacy for paralysis at short and long term follow-up, and 2- to confirm rTMS safety. Two rTMS sessions will be performed at D0 and D1 (120 pulses over 2 days, delivered over the motor cortex at 2 Hz) with an active or a sham coil. Post-rTMS assessment will evaluate 1- the degree of the paralysis at D2 (quantified by a videotape) and D60 (quantified by an interview and a standardized examination), 2- the number and gravity of side effects.

If psychogenic paralysis improvement by motor cortex rTMS is confirmed, rTMS could be considered a useful early therapeutic option.

location_facility:
Rouen University Hospital
Caen University Hospital

intervention_type: Device


title: Influence of Oral Treatment With Citicoline for the Prevention of Radiation Optic Neuropathy in Patients Treated for Uveal Melanomas With Proton Beam Therapy

summary:
Proton beam irradiation is the treatment of choice for uveal melanomas. It has favorable results in causing tumor regression while preserving the eye. Optic neuropathy has emerged consistently as an irreversible cause of visual loss in proton beam irradiated eyes. No neuroprotective strategies are available at present.

Citicoline is a choline agent precursor available as a dietary supplement. Citicoline conferred acute neuroprotection and enhanced neuroplasticity in experimental stroke models. In ophthalmology, citicoline has demonstrated a significant action in improving retinal and cortical responses in patients with optic nerve diseases (glaucoma, ischemic optic neuropathy). Citicoline also exhibits a very low toxicity profile in humans.

The purpose of the study is to demonstrate whether daily oral administration of citicoline in patients treated for uveal melanomas with proton beam therapy, prevents or delays the occurrence of radiation optic neuropathy. Changes in visual acuity, Pattern ERG and visual evoked potentials are measured. The tolerability/safety of the product is also evaluated.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Ophtalmology Departement, St Roch Hopital, Nice University Hospital

intervention_type: Dietary Supplement

status_simplified: Ongoing


title: Phase I Study of the Combination of Axitinib (AX) Plus Everolimus (EV) in Patients With Malignant Advanced Solid Tumors

acronym: EVAX

summary: The aim of the study is to determine the MTD of the combination of everolimus plus axitinib in solid tumors, especially RCC.

ReferenceType: background

ReferenceCitation: Su Y, Amiri KI, Horton LW, Yu Y, Ayers GD, Koehler E, Kelley MC, Puzanov I, Richmond A, Sosman JA. A phase I trial of bortezomib with temozolomide in patients with advanced melanoma: toxicities, antitumor effects, and modulation of therapeutic targets. Clin Cancer Res. 2010 Jan 1;16(1):348-57. doi: 10.1158/1078-0432.CCR-09-2087. Epub 2009 Dec 22.

ReferenceCitation: O'Reilly T, Lane HA, Wood JM, Schnell C, Littlewood-Evans A, Brueggen J, McSheehy PM. Everolimus and PTK/ZK show synergistic growth inhibition in the orthotopic BL16/BL6 murine melanoma model. Cancer Chemother Pharmacol. 2011 Jan;67(1):193-200. doi: 10.1007/s00280-010-1307-z. Epub 2010 May 30.

ReferenceCitation: Choueiri TK. Axitinib, a novel anti-angiogenic drug with promising activity in various solid tumors. Curr Opin Investig Drugs. 2008 Jun;9(6):658-71. Review.

lead_sponsor: University Hospital, Bordeaux

location_facility:
Professeur Alain RAVAUD
Professeur Jean-Pierre DELORD


title: Impact of Cancer on Memory Functioning: Understanding Disorders Using Approaches in Neuropsychology and Neuroimaging

acronym: CANMEM

summary: The purpose of this study is to investigate memory problems in patients with cancer.

status: Terminated

design_allocation: Non-Randomized

lead_sponsor: Centre Francois Baclesse

location_facility:
Centre de recherche CYCERON
Centre François BACLESSE

status_simplified: Unknown


title: Prospective Multicenter Pilot Study Evaluating the Analgesic Effect of an Injection of Botulinum Toxin Type A in the Ganglion Impar in Patients With Chronic Proctalgia According to the Criteria of Rome III

acronym: Impartox

summary: The main objective is to evaluate the analgesic efficacy of botulinum toxin type A in refractory chronic proctalgia one month after a bilateral injection of 50 units of Botox ® in the ganglion Impar (total dose = 100 units)

lead_sponsor: Nantes University Hospital

location_facility:
Nantes University Hospital
Centre Catherine de Sienne


title: Staging Candidiasis in ICU Patients

summary: Our primary objective is to evaluate the relevance of the early determination of Candida infection status among non-neutropenic patients hospitalized over 48 hours in ICUs.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU de Montpellier
CHU de Nîmes

intervention_type: Biological


title: Positron Emission Tomography - Computed Tomography (PET/CT) Scanning for the Follow-up of Antibiotic Treatment of Infectious Osteoarthritis in the Diabetic Foot

acronym: ISEOD

summary: The investigators' primary objective is to assess the predictive power of PET/CT scanning in the evolution of infectious osteoarthritis of the diabetic diabetic after antibiotic therapy prescribed by national and international recommendations.

primary_purpose: Diagnostic

location_facility: Centre Hospitalier Universitaire de Nîmes

location_facility: CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi


title: Perineal Echography in the Delivery Room for the Detection of Anal Lesions Among Primiparous Mothers: a Randomized Study

acronym: OASIS 1

summary: The main objective of this study is to compare the rate of anal incontinence (measured by the Wexner score, qualitative and quantitative (> 4)) at 3 months post partum among primiparas with vaginal tears ≥ 2nd degree who receive a sphincter injury screening at delivery by conducting a sphincter ultrasound in the delivery room versus a similar group of women who do not benefit from screening.


ReferenceCitation: Walker SM. Pain in children: recent advances and ongoing challenges. Br J Anaesth. 2008 Jul;101(1):101-10. doi: 10.1093/bja/aen097. Epub 2008 Apr 21. Review.

family: Walker

full_name: S.M. Walker

journal_name: British Journal of Anaesthesia

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Walco GA, Dworkin RH, Krane EJ, LeBel AA, Treede RD. Neuropathic pain in children: Special considerations. Mayo Clin Proc. 2010 Mar;85(3 Suppl):S33-41. doi: 10.4065/mcp.2009.0647. Review.

family: Walco

full_name: Gary A. Walco

given: Gary A.

family: Dworkin

full_name: Robert H. Dworkin

given: Robert H.

family: Krane

full_name: Elliot J. Krane

given: Elliot J.

family: LeBel

full_name: Alyssa A. LeBel

given: Alyssa A.

family: Treede

full_name: Rolf-Detlef Treede

given: Rolf-Detlef

journal_name: Mayo Clinic Proceedings

oa_host_type: repository

title: Neuropathic Pain in Children: Special Considerations

ReferenceCitation: Garnock-Jones KP, Keating GM. Lidocaine 5% medicated plaster: a review of its use in postherpetic neuralgia. Drugs. 2009 Oct 22;69(15):2149-65. doi: 10.2165/11203220-000000000-00000. Review.

family: Garnock-Jones

full_name: Karly P. Garnock-Jones

given: Karly P.

family: Keating

full_name: Gillian M. Keating

given: Gillian M.

journal_name: Drugs

publisher_dissemination: Springer

publisher_group: Springer

title: Lidocaine 5% Medicated Plaster

ReferenceCitation: Rowbotham MC, Davies PS, Verkempinck C, Galer BS. Lidocaine patch: double-blind controlled study of a new treatment method for post-herpetic neuralgia. Pain. 1996 Apr;65(1):39-44. doi: 10.1016/0304-3959(95)00146-8.

family: Rowbotham

full_name: Michael C. Rowbotham

given: Michael C.

family: Davies

full_name: Pamela S. Davies

given: Pamela S.

family: Verkempinck

full_name: Christina Verkempinck

given: Christina

family: Galer

full_name: Bradley S. Galer

given: Bradley S.

publisher: Ovid Technologies (Wolters Kluwer Health)

location_facility: Centre Médico-chirurgical de Réadaptation des Massues

title: VERSATIS - Efficacy and Safety of Lidocaine 5% Plasters (Versatis® 5%) in Child, Adolescents and Young Adults With Neuropathic Pains or Vasoocclusive Sickle Cell Crisis Pains

summary:
Lidocaine 5% plaster (VERSATIS® 5%) showed its efficacy and safety in the post-herpetic zoster adult pains. This treatment is recommended in first intention in adult neuropathic pains with allodynia.

The purpose of this study is to assess efficacy and safety of lidocaine 5% plaster (VERSATIS® 5%) in the pediatric neuropathic pains and vasoocclusive sickle cell crises pains.


title: Phase I of Radioimmunotherapy (RIT) in MULTIPLE MYELOMA Using the Antibody B-B4 Radiolabelled With IODE 131

summary:
The first step of this protocol called step pre-treatment study the biodistribution and pharmacokinetics of a tracer dose of radiolabeled antibody. The second step called step therapy study the toxicity and antitumor effects of antibody B-B4 coupled with increasing doses of iodine 131. At least 17 patients will be included for an estimated duration of 2 years to determine the maximum tolerated dose and dose limiting toxicity. The immediate side effects, medium and long terms will be analyzed. After determining the toxic dose limit, patients will be treated at the maximum tolerated dose, for a total of 15 patients at this level, which will measure the objective tumor response to treatment. These patients will be followed for 1 year after injection therapy.

ÉcouterLire phonétiquement

lead_sponsor: Centre René Gauducheau

location_facility:
Centre René Gauducheau
Moreau


title: Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus®

summary:
Cystic fibrosis (CF) is a genetic disease characterized by mutations in CFTR (Cystic Fibrosis Transmembrane conductance Regulator) gene. Mortality and morbidity are mostly related to the respiratory affection which appears early in neonates.

The constant improvement in symptomatic treatments and care strategies allowed CF patients' life expectancy to be increased over the last decades.

Vital prognostic is related to bronchopulmonary infections. 39% of CF patients under 18 years old and 70% of adult CF patients are chronically infected by Pseudomonas aeruginosa.

Elevated concentrations of tobramycin in broncho secretions, about 1000 times the MIC, is obtained by inhaled administration of tobramycin and is active against in vitro resistant Pseudomonas aeruginosa.

Study hypotheses :

Regarding literature data and in vitro studies, the administration of Nebcinal® 150mg/3ml administered twice a day by Aeroneb® Idehaler® pocket® would deliver the same quantity of antibiotic in lung and plasma as Tobi® 300mg/5ml administered twice a day by Pari® LC Plus® in children and adult patients with CF.

Primary objective :

To compare plasma concentrations after inhalation of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket® and Tobi® 300 mg/5ml administered by Pari LC Plus®

status: Unknown status

lead_sponsor: Erempharma

location_facility: Centre de ressources et de compétences pour la mucovisidose, adultes

location_facility: Centre de ressources et de compétences pour la mucovisidose, enfants


summary: Accurate characterization of malignant cells obtained via thoracocentesis is of paramount importance in the management of cancer patients. The identification of novel biomarkers may in that regard considerably improve the diagnostic approach of these pleural effusions, guide therapeutic decisions, particularly with respect to targeted therapies, and offer helpful prognostic information. Nuclear anomalies represent the cornerstone of the cytologic and/or histopathologic diagnosis of malignant cells. The nuclear matrix is a fundamental constituent of the nuclear architecture via its interaction with the nuclear membrane, but is also directly involved with DNA and RNA processing. Prior studies have suggested that in some cancers, the lamins, a major constituent of the nuclear matrix, have different patterns of expression or nuclear localization that could potentially have prognostic implications. Our project aims at studying the constituents of the nuclear matrix of malignant cells isolated for pleural fluid in patients with metastatic disease, both of bronchogenic or non-bronchogenic origin, which, to our knowledge, has not yet been done. Both proteomic (localization by immunofluorescence and expression by Western-Blot) and genomic (microarray, CGH type) analyses will be undertaken to identify microrearrangements in the genes of interest. The primary aim is to identify specific biomarkers to more accurately characterize malignant cells in metastatic pleural disease.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille

location_facility: Assistance Publique des Hôpitaux de Marseille

intervention_type: Genetic


ipd_sharing_description: Data available upon request.

ipd_sharing: Yes

type: EudraCT Number

source: euctr

title: Randomized Study Evaluating the Efficacy and Safety of Remifentanil in a Rapid Sequence Induction for Fragile Subjects

summary: The primary objective is to determine whether, during a rapid sequence intubation by etomidate, and succinylcholine Sellick maneuver, the administration of remifentanil at 2 different dosages (0.5 and 1.0 microgram per kg body weight), reduces potentially dangerous reactional tachycardia.


title: PET / CT With 18F-FDG (18F-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography): Does it Optimize the I 123-MIBG (Iodine 123 Metaiodobenzylguanidine) Imaging Results in the Search for Discriminating Factors for the Implementation of an Implantable Defibrillator for Primary Prevention in Patients With Heart Failure of Ischemic Origin?

summary:
The main objective of this study is to determine among the patients included a subpopulation that does not need a defibrillator.

This will be done by comparing the number of discordant segments (mismatch) between patients who have a severe arrhythmia (ventricular tachycardia or ventricular fibrillation) with appropriate electrical therapy within 3 years of monitoring and others. "Mismatch" in the definition of this objective is the usual definition: score 3.4 in I123-MIBG (Iodine 123 metaiodobenzylguanidine) and PET at 0,1,2.

location_facility: Centre Hospitalier Universitaire de Montpellier

intervention_type: Other


title: Optimization of Arterial Oxygen Transport by Positive End-expiratory Pressure Variation in Acute Respiratory Distress Syndrome

acronym: OPTIPEP

summary:
Despite improving in the treatment of acute respiratory distress syndrome (ARDS), this affection keep an elevate rate of death. The strategy of mechanical ventilation is more and more under definite protocol, following large strength randomized studies. Although, it doesn't exist today element allowing to adjust the level of Positive End-Expiratory Pressure (PEEP) with improvement in patient's survival.

The investigators proposed in this study to determinate the level of PEEP adjust to obtain the better arterial oxygen transport (TaO2). The investigators going to conduct a physiologic, observational, none controlled study. All patients hospitalized in intensive care unit of Pontchaillou hospital with ARDS criteria and without specific exclusion criteria will be included. Primary objective is to looking for the optimum level of PEEP for TaO2.

lead_sponsor: Rennes University Hospital

location_facility:
Perigueux Hospital
Rennes University Hospital


title: EVALUATION OF TWO SECONDARY CARE STRATEGIES AFTER STROKE OR TRANSIENT ISCHEMIC ATTACK (TIA): ACHEIVED TARGET LDL-C TO 100 mg/dL (+/- 10,mg/dL) OR LESS THAN 70 mg/dL.

acronym: TST

summary:
The aim of this study is the evaluation of two usual care strategies after stroke or TIA : achieved target LDL-C of 100 mg/dL (+/-10 mg/dL) or less than 70 mg/dL. Investigators will use the statin and titrate the dosage to achieve the target assigned by randomization in monotherapy or in combination with ezetimibe or other drugs.

The primary end-point is the occurrence of recurrent non fatal stroke, non fatal MI, and vascular death in each group.

3760 patients will be recruited and followed for eight and a half years maximum.

ReferenceCitation: Amarenco P, Kim JS, Labreuche J, Charles H, Giroud M, Lee BC, Lavallée PC, Mahagne MH, Meseguer E, Nighoghossian N, Steg PG, Vicaut É, Bruckert E; Treat Stroke to Target Investigators; Treat Stroke to Target investigators:. Impact of Lower Versus Higher LDL Cholesterol Targets on Cardiovascular Events After Ischemic Stroke in Patients With Diabetes. Diabetes. 2021 Aug;70(8):1807-1815. doi: 10.2337/db21-0302. Epub 2021 May 12.

family: Amarenco

full_name: Pierre Amarenco

given: Pierre

family: Kim

full_name: Jong S. Kim

given: Jong S.

family: Labreuche

full_name: Julien Labreuche

given: Julien

family: Charles

full_name: Hugo Charles

given: Hugo

family: Giroud

full_name: Maurice Giroud

given: Maurice

family: Lee

full_name: Byung-Chul Lee

given: Byung-Chul

family: Lavallée

full_name: Philippa C. Lavallée

given: Philippa C.

family: Mahagne

full_name: Marie-Hélène Mahagne

given: Marie-Hélène

family: Meseguer

full_name: Elena Meseguer

given: Elena

family: Nighoghossian

full_name: Norbert Nighoghossian

given: Norbert

family: Steg

full_name: Philippe Gabriel Steg

given: Philippe Gabriel

family: Vicaut

full_name: Éric Vicaut

given: Éric

family: Bruckert

full_name: Eric Bruckert

given: Eric

journal_name: Diabetes

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

ReferenceCitation: Amarenco P, Hobeanu C, Labreuche J, Charles H, Giroud M, Meseguer E, Lavallée PC, Gabriel Steg P, Vicaut É, Bruckert E, Touboul PJ. Carotid Atherosclerosis Evolution When Targeting a Low-Density Lipoprotein Cholesterol Concentration <70 mg/dL After an Ischemic Stroke of Atherosclerotic Origin. Circulation. 2020 Aug 25;142(8):748-757. doi: 10.1161/CIRCULATIONAHA.120.046774. Epub 2020 Jun 29.

name: Department of Neurology and Stroke Center (P.A., C.H., H.C., E.M., P.C.L., P.-J.T.)

family: Hobeanu

full_name: Cristina Hobeanu

given: Cristina

name: EA 2694–Santé Publique: Épidémiologie et Qualité des Soins, Université Lille, CHU Lille, France (J.L.).

name: Department of Neurology, University Hospital of Dijon, University of Burgundy, France (M.G.).

name: Department of Cardiology (P.G.S.), APHP, Bichat Hospital, INSERM LVTS-U1148, DHU FIRE, University of Paris, France.

family: Gabriel Steg

name: Department of Biostatistics, APHP, Fernand Widal Hospital, Université Paris-Diderot, Sorbonne-Paris Cité, France (É.V.).

name: Department of Endocrinology, APHP, Pitié-Salpêtrière Hospital, Sorbonne University, Paris, France (E.B.).

ReferenceCitation: Amarenco P, Kim JS, Labreuche J, Charles H, Giroud M, Lee BC, Mahagne MH, Nighoghossian N, Gabriel Steg P, Vicaut É, Bruckert E; Treat Stroke to Target Investigators. Benefit of Targeting a LDL (Low-Density Lipoprotein) Cholesterol <70 mg/dL During 5 Years After Ischemic Stroke. Stroke. 2020 Apr;51(4):1231-1239. doi: 10.1161/STROKEAHA.119.028718. Epub 2020 Feb 20.

name: From the APHP, Department of Neurology and Stroke center, Bichat Hospital, INSERM LVTS-U1148, DHU FIRE, University of Paris, France (P.A., J.L., H.C.)

name: Asan Medical Center, Seoul, South Korea (J.S.K.)

name: Department of Neurology, Hallym University Sacred Heart Hospital, Anyang, Korea (B.-C.L.)

name: Stroke Unit, Pasteur Hospital, Nice, France (M.-H.M.)

name: Hospices Civils de Lyon, Department of Neurology and Stroke Center, Lyon University, France (N.N.)

name: APHP, Department of cardiology, INSERM LVTS-U1148, DHU FIRE, University of Paris, Hôpital Bichat, France (P.G.S.)

name: NHLI Imperial College, ICMS Royal Brompton Hospital London, United Kingdom (P.G.S.)

name: APHP, Department of Biostatistics, Université Paris-Diderot, Sorbonne-Paris Cité, Fernand Widal hospital, France (É.V.)

name: APHP, Department of Endocrinology, Pitié-Salpêtrière hospital, Sorbonne University, Paris, France (E.B.).

ReferenceCitation: Amarenco P, Kim JS, Labreuche J, Giroud M, Lee BC, Mahagne MH, Nighoghossian N, Simon T, Steg PG, Touboul PJ, Vicaut E, Yelles N, Bruckert E. Treat stroke to target trial design: First trial comparing two LDL targets in patients with atherothrombotic strokes. Eur Stroke J. 2019 Sep;4(3):271-280. doi: 10.1177/2396987319838100. Epub 2019 Mar 26.

name: Assistance Publique-Hôpitaux de Paris (APHP), Department of Neurology and Stroke Center, Bichat Hospital, INSERM LVTS-U1148, DHU FIRE, Université Paris-Diderot, Sorbonne-Paris Cité, Paris, France (Pierre Amarenco, Pierre-Jean Touboul)

name: Department of Neurology, Asan Medical Center, Seoul

name: Université Lille, CHU Lille, EA 2694 – Santé publique: épidémiologie et qualité des soins, F-59000 Lille, France (Julien Labreuche)

name: Department of Neurology, INSERM, Université Bourgogne, Dijon, France (Maurice Giroud)

name: Stroke Unit, Pasteur hospital, Nice, France (Marie-Hélène Mahagne)

name: Hospices Civils de Lyon, Department of Neurology and Stroke center, Lyon University, Lyon, France (Norbert Nighoghossian)

name: APHP, Department of Clinical Pharmacology and Clinical Research Platform of East of Paris (CRC-CRB-URC), Saint Antoine University Hospital, Paris, France ; Sorbonne University, France (Tabassome Simon)

name: APHP, Department of Cardiology, INSERM LVTS-U1148, DHU FIRE, Université Paris-Diderot, Sorbonne-Paris Cité, Hôpital Bichat, Paris, France; and NHLI Imperial College, ICMS Royal Brompton Hospital London, UK (Philippe Gabriel Steg)

name: APHP, Department of Biostatistics, Université Paris-Diderot, Sorbonne-Paris Cité, Fernand Widal hospital, Paris, France (Éric Vicaut)

name: APHP, Centre de Pharmaco-épidémiologie de l’AP-HP (CEPHEPI), Hôpital Pitié-Salpêtrière, Paris, France

name: APHP, Pitié-Salpêtrière University Hospital, Pierre and Marie Curie University, Sorbonne-Paris Cité, Paris, France

ReferenceCitation: Amarenco P, Kim JS, Labreuche J, Charles H, Abtan J, Béjot Y, Cabrejo L, Cha JK, Ducrocq G, Giroud M, Guidoux C, Hobeanu C, Kim YJ, Lapergue B, Lavallée PC, Lee BC, Lee KB, Leys D, Mahagne MH, Meseguer E, Nighoghossian N, Pico F, Samson Y, Sibon I, Steg PG, Sung SM, Touboul PJ, Touzé E, Varenne O, Vicaut É, Yelles N, Bruckert E; Treat Stroke to Target Investigators. A Comparison of Two LDL Cholesterol Targets after Ischemic Stroke. N Engl J Med. 2020 Jan 2;382(1):9. doi: 10.1056/NEJMoa1910355. Epub 2019 Nov 18.

name: From the Department of Neurology and Stroke Center (P.A., J.L., H.C., L.C., C.G., C.H., P.C.L., E.M., P.-J.T.) and the Department of Cardiology (J.A., G.D., P.G.S.), Assistance Publique–Hôpitaux de Paris (APHP), Bichat Hospital, Laboratory for Vascular Translational Science, INSERM Unité 1148, Département Hospitalo Universitaire–Fibrose Inflammation Remodelage, and the Department of Cardiology, Cochin Hospital (O.V.), University of Paris, the Department of Neurology, Foch Hospital (B.L.), Urgences...

location_facility: BICHAT HOSPITAL Departement of Neurology

location_facility: BICHAT HOSPITAL Department of neurology and stroke center


title: Are Ante-hypophyseal Dysfunctions in the Acute Phase of Moderate to Severe Traumatic Brain Injury Predictive of Long-term Ante-hypophyseal Sequelae in Children?

acronym: Endoc-TC

summary:
Annual incidence of severe traumatic brain injuries (TBI) varies from 180 to 300 out of 100.000. Mortality or severe sequelae risk is increased 8 fold after a TBI. Studies in adults showed an ante-hypophyseal deficit in 28 to 68 % of patients with a TBI. The most common deficit is Growth Hormone Deficit (GHD); followed by gonadotropic and corticotropic (AdrenoCorticoTropic Hormone (ACTH)) insufficiencies. Thyrotropic deficits (Thyroid-Stimulating Hormone (TSH)) are less frequent. From a pathophysiological point of view, the lesional mechanism responsible for hypopituitarisms would be a damage of hypophyseal vessels or hypothalamic-pituitary vessels. The frequency of pituitary deficits and the potential beneficial effects of replacement therapy on quality of life, tiredness, loss of energy and productivity, justify the systematic detection of the deficits in patients with moderate to severe TBI.

Study hypotheses :

At the present time, the lack of data in children does not give us the opportunity to affirm that one part of the symptoms showed by children with post-TBI neuropsychological sequelae, are linked to pituitary deficiency and that they can be improved with a replacement therapy.

Firstly, it is essential to better understand the natural history of post-TBI pituitary deficiencies, studying the connexion between observed deficiencies in acute and late phase of sequelae.

lead_sponsor: Hospices Civils de Lyon

location_facility:
CHU de Grenoble
Hospices Civils de Lyon


title: Safety and Efficacy of Combined Extracorporeal CO2 Removal and Renal Replacement Therapy in Patients With the Acute Respiratory Distress Syndrome and Acute Renal Failure

acronym: PARSA

summary:
In patients presenting with the acute respiratory distress syndrome (ARDS), mechanical ventilation with low tidal volume (6 ml/kg predicted body weight) is the current gold standard for supportive care. However, despite a relative low tidal volume, approximatively one third of patients will experienced tidal hyperinflation, a phenomenon known to induce pulmonary and systemic inflammatory response. A further reduction of the tidal volume to 4 ml/kg (PBW) will prevent pulmonary area from tidal hyperinflation. As a result, hypercarbia and respiratory acidosis are commonly observed with such very low tidal ventilation. Extra corporeal CO2 removal is one of a mean to normalize arterial CO2 tension.

Patients with ARDS also frequently develop acute renal failure which may required Renal Replacement Therapy. Some data suggests that starting early the RRT may favor outcome.

The investigators hypothesized that a strategy combining ECCOR and RRT early in the course of patients presenting ARDS and acute renal failure will allow the tidal volume to be further reduced, providing lung protection, while avoiding the arterial CO2 tension to be increased.

For this purpose, the investigators sought to evaluate the safety and efficacy of adding a membranel oxygenator within an hemofiltration circuit, either upstream or downstream of the hemofilter.

primary_purpose: Supportive Care

ReferenceCitation: Terragni PP, Rosboch G, Tealdi A, Corno E, Menaldo E, Davini O, Gandini G, Herrmann P, Mascia L, Quintel M, Slutsky AS, Gattinoni L, Ranieri VM. Tidal hyperinflation during low tidal volume ventilation in acute respiratory distress syndrome. Am J Respir Crit Care Med. 2007 Jan 15;175(2):160-6. Epub 2006 Oct 12.

ReferenceCitation: Terragni PP, Del Sorbo L, Mascia L, Urbino R, Martin EL, Birocco A, Faggiano C, Quintel M, Gattinoni L, Ranieri VM. Tidal volume lower than 6 ml/kg enhances lung protection: role of extracorporeal carbon dioxide removal. Anesthesiology. 2009 Oct;111(4):826-35. doi: 10.1097/ALN.0b013e3181b764d2.

family: Terragni

full_name: Pier Paolo Terragni

given: Pier Paolo

family: Del Sorbo

full_name: Lorenzo Del Sorbo

given: Lorenzo

family: Mascia

full_name: Luciana Mascia

given: Luciana

family: Urbino

full_name: Rosario Urbino

given: Rosario

family: Martin

full_name: Erica L. Martin

given: Erica L.

family: Birocco

full_name: Alberto Birocco

given: Alberto

family: Faggiano

full_name: Chiara Faggiano

given: Chiara

name: Professor of Anesthesia, Department of Anesthesiology, University of Gottingen, Gottingen, Germany.

family: Quintel

full_name: Michael Quintel

given: Michael

name: Professor of Anesthesia, Istituto di Anestesia e Rianimazione, Fondazione IRCCS – Ospedale Maggiore Policlinico, Mangiagalli, Regina Elena” di Milano, and Università degli Studi di Milano, Italy.

family: Gattinoni

full_name: Luciano Gattinoni

given: Luciano

name: Professor of Anesthesia, Dipartimento di Anestesiologia e Medicina degli Stati Critici, Università di Torino, Ospedale S. Giovanni Battista-Molinette, Torino, Italy.

family: Ranieri

full_name: V Marco Ranieri

given: V Marco

journal_name: Anesthesiology

evidence: open (via free pdf)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Tidal Volume Lower than 6 ml/kg Enhances Lung Protection

lead_sponsor: Hôpital Européen Marseille

location_facility:
Hopital Ambroise Pare
Hopital Paul Desbief


title: Coronary Flow Reserve Evaluation in PET and in MRI Scanner in Heart Transplanted Patients : Comparison With Multi-detectors Scanner

acronym: RECOPE

summary: Heart transplantation is the ultimate therapeutic option in patients with end-stage heart failure. Since advances in the treatment of acute rejection has increased early transplant survival, cardiac allograft vasculopathy (CAV) is the main factor limiting long-term survival. The prevalence of angiographically proven CAV is high, documented in 40-50% of transplant recipients 5 years after transplantation. Therefore, annual coronary angiography remains widely used to monitor transplanted patients, although pathologic studies and intravascular ultrasonography have demonstrated that coronary angiography underestimates the severity of CAV. Perfusion SPECT may underestimate allograft vasculopathy in case of diffuse coronary lesions. In this setting, the assessment of coronary reserve by means of Positron Emission Tomography (PET) and perfusion cardiac magnetic resonance imaging (CMR) have not been investigated.

lead_sponsor: University Hospital, Caen

location_facility:
CHU de Rouen
CHU de Caen - GIP Cyceron

intervention_type: Radiation


title: Comparative Study of Two Haemodialyzers "VIE 2.1" Versus "EVODIAL2.2" in a Strategy of Heparin-free Haemodialysis (HFH)

summary: The adequate anti coagulation is an absolute necessity in order to avoid the extra-corporal circuit and haemodialyzer clotting and to perform an adequate renal replacement therapy during a haemodialysis session. In the cases of multiple coagulation defects having high haemorrhagic risk factors and the patients under anti-coagulation therapy, it is recommended to reduce the heparin doses or to do heparin free haemodialysis. Several strategies of low heparin or heparin free haemodialysis have been proposed till now, without a real success. The heparin coated polyacrylonitrile haemodialyser (EVODIAL) has been reported to have 90 % successful heparin-free haemodialysis sessions. On the other hand, the vitamin E coated polysulphone (VIE) has also been reported to have an anti oxidative and anti-thrombotic properties and a capacity to improve the haemorrheological factors of human blood, hence having a promising future to perform a successful haemodialysis session with less or without heparin. This randomised, multi-centric, cross-over and open study has been designed to compare non inferiority of the haemodialyzer VIE 2,1 versus EVODIAL2,2 with a risk alfa of 5% and an absolute accepted difference of 12 %.

location_facility:
Centre Hospitalier
CHU de Nice


acronym: Infiltrations sur ATLS

location_facility:
Hospital of La Roche/Yon
Nantes Hospital

title: Involvement of Transverso-sacral- Neo- Articulations or of Transverso-iliac Articulations in Chronic Lumbago: Prospective Multicentric , Double-Blinded, Randomized of the Efficacy of corticoïd Infiltration Versus Physiological Solution Infiltration

summary: The specific aim of this study is to determine whether, when treated with corticoid infiltration, certain chronic lumbagos could be explained by the presence of a neo-articulation.The primary criteria is to determine the difference between the mean pain during the latest 24 hours preceding the infiltration and the mean pain preceding the visit S4 (visit 4 weeks after the infiltration)


title: Evaluation of Macrophagic Activation and Immunophenotypic Profile of Patients With Gaucher's Disease.

acronym: Gaucher

summary: The aim of this study is to evaluate macrophaging activity and immunologic profile of patients with Gaucher 's disease. For this, one blood sampling will be performed.

primary_purpose: Basic Science

location_facility:
CHU of Rennes
Nantes Hospital


title: Hepatic and Renal Thermography Using Magnetic Resonance Imaging

acronym: THeR-IRM

summary: Several technological challenges exist to apply Magnetic Resonance guided High Intensity Focused Ultrasound (MRgHIFU) for treatment of liver or kidney in particular challenges related to the motion of these organs. This study tests a new software to improve thermometry accuracy in mobile organs in patients with liver or kidney tumors. In the same time, the trajectory of the target in 3D is analyzed.

location_facility: Service de radiologie - Hôpital PELLEGRIN - CHU de Bordeaux

location_facility: Service of medical Imaging St André Hospital - CHU de BORDEAUX


title: Hemodynamic Assessment With Transpulmonary Thermodilution and Transesophageal Echocardiography in Patients With Early Septic Shock

acronym: HEMOSEPSIS

summary: The purpose of this study is to assess the concordance of therapeutic changes proposed after an early hemodynamic evaluation (hemodynamic profile) in septic shock patients using jointly the transpulmonary thermodilution technique and transesophageal echocardiography (TEE).

ReferenceCitation: Vignon P, Begot E, Mari A, Silva S, Chimot L, Delour P, Vargas F, Filloux B, Vandroux D, Jabot J, François B, Pichon N, Clavel M, Levy B, Slama M, Riu-Poulenc B. Hemodynamic Assessment of Patients With Septic Shock Using Transpulmonary Thermodilution and Critical Care Echocardiography: A Comparative Study. Chest. 2018 Jan;153(1):55-64. doi: 10.1016/j.chest.2017.08.022. Epub 2017 Sep 1.

family: Vignon

full_name: Philippe Vignon

given: Philippe

family: Begot

full_name: Emmanuelle Begot

given: Emmanuelle

family: Mari

full_name: Arnaud Mari

given: Arnaud

family: Silva

full_name: Stein Silva

given: Stein

family: Chimot

full_name: Loïc Chimot

given: Loïc

family: Delour

full_name: Pierre Delour

given: Pierre

family: Vargas

full_name: Frédéric Vargas

given: Frédéric

family: Filloux

full_name: Bruno Filloux

given: Bruno

family: Vandroux

full_name: David Vandroux

given: David

family: Jabot

full_name: Julien Jabot

given: Julien

family: François

full_name: Bruno François

family: Pichon

full_name: Nicolas Pichon

given: Nicolas

family: Clavel

full_name: Marc Clavel

given: Marc

family: Levy

full_name: Bruno Levy

family: Slama

full_name: Michel Slama

given: Michel

family: Riu-Poulenc

full_name: Béatrice Riu-Poulenc

given: Béatrice

journal_name: Chest

lead_sponsor: University Hospital, Limoges

location_facility:
Bordeaux UH
Toulouse UH

intervention_type: Combination Product


title: Randomized Study Comparing the Interest of a Program of Evaluation and Geriatric Intervention on the Functional Status, Quality of the Life, and Survival of Elderly Patients With Acute Myeloid Leukaemia. MLSP/IPC 2009-003

acronym: MLSP

summary:
Acute myeloid leukaemia (AML) is a disease of the elderly, with a median age at diagnosis of 65. A poor outcome in this population has been well established, with very short overall survival (OS) and disease free survival (DFS).There are numerous bad prognostic factors related to the disease itself or to the patient's medical condition.

This study will evaluate the impact of a Comprehensive Geriatric assessment (CGA) performed at diagnosis with planned interventions according to disabilities and monthly follow-up by a nurse practitioner during 6 months on functional status of older cancer patients treated for Acute myeloid leukaemia. Functional status will be assessed with the Lawson Instrumental Activities of Daily Living (IADL) scale at diagnosis and 6 months after randomisation.

lead_sponsor: Institut Paoli-Calmettes

location_facility:
Aude CHARBONNIER, MD
Christian RECHER

intervention_type: Behavioral


title: Study of Tolerance and Lipid Digestibility of a Formula in Healthy 3 Months Infants

summary: The great majority of infants formula contain fats exclusively from vegetable oil. Nevertheless, the use of both vegetable and dairy lipids is on a real interest to obtain an infant formula closer to the nutritional composition of maternal milk.

lead_sponsor: Lactalis

location_facility:
Hopital Mère-Enfants
Faculté de Médecine


title: Genetic Analysis of Familial Cases of Premature Ovarian Failure

acronym: FAMIOP

summary: The Premature ovarian failure (POF) is a rare syndrome observed in women under 40 who induced estrogen deficiency and often leads to infertility final. The etiologies of POF remain unknown in more than 85% of cases. There are 5-10 % of familial cases.The main objective of this study is to recruit, phenotype and genotype 20 families with at least two subjects with nonsyndromic POF in order to identify new loci using a single technical standard nucleotide polymorphisms (SNPs). This study will also include related population and population control.

ReferenceCitation: Lebedin YS, Gorchakov VD, Petrova EN, Kobylyansky AG, Raudla LA, Tatarsky AR, Bobkov EV, Adamova IY, Vasilov RG, Nasonov EL, et al. Ex vivo removal of IgE in atopic asthma by extracorporeal plasmoimmunoadsorption (EPIA): development of a clinical adsorbent. Int J Artif Organs. 1991 Aug;14(8):508-14.

ReferenceCitation: Knauff EA, Franke L, van Es MA, van den Berg LH, van der Schouw YT, Laven JS, Lambalk CB, Hoek A, Goverde AJ, Christin-Maitre S, Hsueh AJ, Wijmenga C, Fauser BC; Dutch POF Consortium. Genome-wide association study in premature ovarian failure patients suggests ADAMTS19 as a possible candidate gene. Hum Reprod. 2009 Sep;24(9):2372-8. doi: 10.1093/humrep/dep197. Epub 2009 Jun 9.

ReferenceCitation: Charbit B, Christin-Maître S, Démolis JL, Soustre E, Young J, Funck-Brentano C. Effects of testosterone on ventricular repolarization in hypogonadic men. Am J Cardiol. 2009 Mar 15;103(6):887-90. doi: 10.1016/j.amjcard.2008.11.041. Epub 2009 Jan 24.

ReferenceCitation: Rousseau A, Ayoubi F, Deveaux C, Charbit B, Delmau C, Christin-Maitre S, Jaillon P, Uzan G, Simon T. Impact of age and gender interaction on circulating endothelial progenitor cells in healthy subjects. Fertil Steril. 2010 Feb;93(3):843-6. doi: 10.1016/j.fertnstert.2008.10.062. Epub 2008 Dec 25.

ReferenceCitation: Warcoin M, Lespinasse J, Despouy G, Dubois d'Enghien C, Laugé A, Portnoï MF, Christin-Maitre S, Stoppa-Lyonnet D, Stern MH. Fertility defects revealing germline biallelic nonsense NBN mutations. Hum Mutat. 2009 Mar;30(3):424-30. doi: 10.1002/humu.20904.

ReferenceCitation: Madelenat P, Koskas M; Groupe de réflexion sur la contraception progestative. [Update on the progestin-only contraception]. J Gynecol Obstet Biol Reprod (Paris). 2008 Nov;37(7):637-60. doi: 10.1016/j.jgyn.2008.06.013. Epub 2008 Sep 27. French.

ReferenceCitation: Beysen D, De Jaegere S, Amor D, Bouchard P, Christin-Maitre S, Fellous M, Touraine P, Grix AW, Hennekam R, Meire F, Oyen N, Wilson LC, Barel D, Clayton-Smith J, de Ravel T, Decock C, Delbeke P, Ensenauer R, Ebinger F, Gillessen-Kaesbach G, Hendriks Y, Kimonis V, Laframboise R, Laissue P, Leppig K, Leroy BP, Miller DT, Mowat D, Neumann L, Plomp A, Van Regemorter N, Wieczorek D, Veitia RA, De Paepe A, De Baere E. Identification of 34 novel and 56 known FOXL2 mutations in patients with Blepharophimosis syndrome. Hum Mutat. 2008 Nov;29(11):E205-19. doi: 10.1002/humu.20819.

ReferenceCitation: Chakhtoura Z, Bachelot A, Samara-Boustani D, Ruiz JC, Donadille B, Dulon J, Christin-Maître S, Bouvattier C, Raux-Demay MC, Bouchard P, Carel JC, Leger J, Kuttenn F, Polak M, Touraine P; Centre des Maladies Endocriniennes Rares de la Croissance and Association Surrénales. Impact of total cumulative glucocorticoid dose on bone mineral density in patients with 21-hydroxylase deficiency. Eur J Endocrinol. 2008 Jun;158(6):879-87. doi: 10.1530/EJE-07-0887. Epub 2008 Apr 7.

ReferenceCitation: Christin-Maitre S. [Physiology of ovulation and mode of action of contraceptive pills]. Rev Prat. 2008 Jan 15;58(1):17-20. Review. French.

ReferenceCitation: Christin-Maitre S. The role of hormone replacement therapy in the management of premature ovarian failure. Nat Clin Pract Endocrinol Metab. 2008 Feb;4(2):60-1. Epub 2007 Nov 20. Review.

ReferenceCitation: Tachdjian G, Aboura A, Portnoï MF, Pasquier M, Bourcigaux N, Simon T, Rousseau G, Finkel L, Benkhalifa M, Christin-Maitre S. Cryptic Xp duplication including the SHOX gene in a woman with 46,X, del(X)(q21.31) and premature ovarian failure. Hum Reprod. 2008 Jan;23(1):222-6. Epub 2007 Nov 1.

ReferenceCitation: Vinci G, Christin-Maitre S, Pasquier M, Bouchard P, Fellous M, Veitia RA. FOXO3a variants in patients with premature ovarian failure. Clin Endocrinol (Oxf). 2008 Mar;68(3):495-7. Epub 2007 Sep 19.

ReferenceCitation: Laissue P, Christin-Maitre S, Bouchard P, Fellous M, Veitia RA. Mutations in the NOG gene are not a common cause of nonsyndromic premature ovarian failure. Clin Endocrinol (Oxf). 2007 Jun;66(6):900. Epub 2007 Mar 23.

ReferenceCitation: Zanotti-Fregonara P, Khoury A, Duron F, Keller I, Christin-Maître S, Kiffel T, Toubert ME, Devaux JY, Hindié E. Which thyroid cancer patients need periodic stimulation tests? Eur J Nucl Med Mol Imaging. 2007 Apr;34(4):541-6. Epub 2006 Nov 14.

ReferenceCitation: Roux C, Briot K, Dumarcet N, Bourgoin M, Chapurlat R, Christin-Maitre S, Cortet B, Costagliola D, Diebolt V, Lacoin F, Letombe B, Oberlin F, Orcel P, Ravaud P, Seret P, Thomas T, Vogel JY, Barna A, Nouyrigat E, Veyries ML, Yoldjian I. [Drug treatment of postmenopausal osteoporosis. What's New in 2006]. Presse Med. 2006 Oct;35(10 Pt 2):1529-39. Review. French.

ReferenceCitation: Laissue P, Christin-Maitre S, Touraine P, Kuttenn F, Ritvos O, Aittomaki K, Bourcigaux N, Jacquesson L, Bouchard P, Frydman R, Dewailly D, Reyss AC, Jeffery L, Bachelot A, Massin N, Fellous M, Veitia RA. Mutations and sequence variants in GDF9 and BMP15 in patients with premature ovarian failure. Eur J Endocrinol. 2006 May;154(5):739-44.

ReferenceCitation: De Baere E, Copelli S, Caburet S, Laissue P, Beysen D, Christin-Maitre S, Bouchard P, Veitia R, Fellous M. Premature ovarian failure and forkhead transcription factor FOXL2: blepharophimosis-ptosis-epicanthus inversus syndrome and ovarian dysfunction. Pediatr Endocrinol Rev. 2005 Jun;2(4):653-60. Review.

ReferenceCitation: Christin-Maitre S, Duron F. Fetal loss associated with excess thyroid hormone exposure. JAMA. 2004 Nov 3;292(17):2085-6; author reply 2086.

ReferenceCitation: Ouzounian S, Christin-Maitre S. [What is menopause?]. Rev Prat. 2005 Feb 28;55(4):363-8. Review. French.

ReferenceCitation: Simon T, Boutouyrie P, Gompel A, Christin-Maitre S, Laurent S, Thuillez C, Zannad F, Bernaud C, Jaillon P; CASHMERE investigators. Rationale, design and methods of the CASHMERE study. Fundam Clin Pharmacol. 2004 Feb;18(1):131-8.

ReferenceCitation: Hulot JS, Démolis JL, Rivière R, Strabach S, Christin-Maitre S, Funck-Brentano C. Influence of endogenous oestrogens on QT interval duration. Eur Heart J. 2003 Sep;24(18):1663-7.

ReferenceCitation: Christin-Maitre S, Ronci-Chaix N, Bouchard P. [Ovary genes and molecular pathology]. J Soc Biol. 2002;196(3):207-16. Review. French.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hospital Saint-Antoine, Endocrinology service


title: Study of Dopamine and Serotonin Transporters in Patients With Amyotrophic Lateral Sclerosis and Controls. Analysis With 123I-FP-CIT (Datscan) and 123I-ADAM Brain SPECT

acronym: DOSERAL

summary:
The purpose of this study is to study the transporters of serotonin and dopamine in ALS patients in relation with the clinical phenotype, i.e., patients without stiffness, patients with pyramidal stiffness, patients with mixed (pyramidal and extra pyramidal) stiffness.

For such a goal the investigators will use SPECT to compare the binding of two specific tracers in ALS patients and in matched healthy controls.

location_facility:
Salpêtrière Hospital
Bretonneau Hospital


title: Intake of Low Dose of Docosahexaenoic Acid: Effects on Platelet Functions and Redox Status in Diabetic Patients

summary:
Aim: to determine the effects of DHA supplementation:

on the platelet function through their aggregation and the pathway of arachidonic acid metabolism
on redox status on cells and plasma
on inflammation in 16 type 2 diabetic patients in a cross-over study comparing DHA (400 mg/day for 2 weeks) vs Sunflower oil (placebo). Each period is separated by a wash-out period of 6 to 9 weeks.

primary_purpose: Other

ReferenceCitation: Véricel E, Colas R, Calzada C, Lê QH, Feugier N, Cugnet C, Vidal H, Laville M, Moulin P, Lagarde M. Moderate oral supplementation with docosahexaenoic acid improves platelet function and oxidative stress in type 2 diabetic patients. Thromb Haemost. 2015 Aug;114(2):289-96. doi: 10.1160/TH14-12-1003. Epub 2015 Apr 2.

family: Colas

full_name: Romain Colas

given: Romain

family: Calzada

full_name: Catherine Calzada

given: Catherine

family: Lê

full_name: Quang Huy Lê

given: Quang Huy

family: Feugier

full_name: Nathalie Feugier

given: Nathalie

family: Cugnet

full_name: Christine Cugnet

given: Christine

family: Vidal

full_name: Hubert Vidal

given: Hubert

family: Laville

full_name: Martine Laville

given: Martine

family: Moulin

full_name: Philippe Moulin

family: Lagarde

full_name: Michel Lagarde

family: Véricel

full_name: Evelyne Véricel

given: Evelyne

journal_name: Thrombosis and Haemostasis

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

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

publisher: Georg Thieme Verlag KG

publisher_dissemination: Georg Thieme

publisher_group: Georg Thieme

publisher_normalized: Georg Thieme

location_facility: Centre de Recherche en Nutrition Humaine (CRNH) Rhône-Alpes


title: Bone Quality and Improvement of Fracture Risk Prediction

acronym: QUALYOR

summary: QUALYOR is a prospective study on the predictive value for fragility fracture of various new techniques assessing bone quality, among postmenopausal women with low bone mass.

ReferenceCitation: Chapurlat R, Pialat JB, Merle B, Confavreux E, Duvert F, Fontanges E, Khacef F, Peres SL, Schott AM, Lespessailles E. The QUALYOR (QUalité Osseuse LYon Orléans) study: a new cohort for non invasive evaluation of bone quality in postmenopausal osteoporosis. Rationale and study design. Arch Osteoporos. 2017 Dec 27;13(1):2. doi: 10.1007/s11657-017-0412-6.

family: Chapurlat

full_name: Roland Chapurlat

given: Roland

family: Pialat

full_name: Jean-Baptiste Pialat

given: Jean-Baptiste

family: Merle

full_name: Blandine Merle

given: Blandine

family: Confavreux

full_name: Elisabeth Confavreux

given: Elisabeth

family: Duvert

full_name: Florence Duvert

given: Florence

family: Fontanges

full_name: Elisabeth Fontanges

family: Khacef

full_name: Farida Khacef

given: Farida

family: Peres

full_name: Sylvie Loiseau Peres

given: Sylvie Loiseau

family: Schott

full_name: Anne-Marie Schott

given: Anne-Marie

family: Lespessailles

full_name: Eric Lespessailles

given: Eric

journal_name: Archives of Osteoporosis

location_facility:
Centre Hospitalier d'Orléans
Hospices Civils de Lyon


title: Surgery Combined With IMRT-IGRT in Locally-advanced Prostate Cancers

acronym: TARGET

summary:
Standard treatment of locally-advanced prostate cancers consists in the association of radiotherapy of prostate and seminal vesicles (SV) and androgen deprivation (AD) for 3 years. This treatment is usually preceded by pelvic lymphadenectomy to assess the possible extension to lymph nodes of prostatic cancer and to avoid irradiating the pelvis in case of no lymph node involvement. However, radiotherapy leads usually to about 30% of grade ≥2 risk of bladder and/or rectal toxicity. This risk particularly depends on the radiation volume. In the aim of lowering the toxicity, the treatment in this study will associate:

pelvic lymph node dissection and resection of seminal vesicles, allowing decreasing the radiation target volume to the prostate only (and not to irradiate the SV);
a high-precision radiotherapy technique combining Intensity Modulated Radiation Therapy (IMRT) and Image-Guided Radiation Therapy (IGRT).

location_facility: Service d'Urologie - Hôpital de Pontchaillou


title: 10 Patients Bicentric Prospective Study of Hybrid Bone Substitution With Calcium-phosphate Ceramic Biomaterial and Autologous Bone Marrow for Mandibular Osteoradionecrosis (ORN) Treatment

acronym: ORN

summary: The main objective of the study is the cure of osteoradionecrosis (ORN) at 12 months.

location_facility:
Nantes University Hospital
Rennes University Hospital


title: Phase I Trial Evaluating Continuous Infusion of Cilengitide Together With Radiochemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer

summary:
This is a two-center study which includes 24 patients maximum on 36 months : 24 months accrual - 12 months follow up.

Eligible patients are included according to a standard 3+3 design.

Patients included in the trial will be treated with a combination of radiochemotherapy (standard radiotherapy of 66 Gy, 2 Gy per daily fraction, and cisplatin and vinorelbine based chemotherapy).

Cilengitide will be administered alone as continuous infusion two weeks before the radiochemotherapy and will then be continued during radiochemotherapy as continuous infusion.

The dose levels investigated will be applied to the continuous administration (a maximum of 4 dose levels).

After the end of concomitant radiochemotherapy, cilengitide will be administered i.v. at a dose of 2000 mg twice weekly until the end of chemotherapy.

The dose of Cilengitide administered after radiotherapy will not be increased. 4 dose levels are defined:12, 18, 27 et 40 mg /hour.

lead_sponsor: Institut Claudius Regaud

location_facility:
Institut Claudius Regaud
CHU Toulouse Larrey


type: Registry Identifier

title: Trisomy of Chromosome 21 Diagnosis by High Output Sequencing of Foetal Circulating DNA in Mother Blood at First Trimester of Pregnancy.

summary: Demonstrate that the High output shotgun sequencing of the foetal DNA in the maternal blood could allow a complete discrimination between the mothers of a trisomic fetus 21 or a DISOMIQUE foetus 21 from the first quarter of the pregnancy, and so to obtain a reliable alternative in invasive procedure.

location_facility:
Chi Poissy St Germain
Necker Enfants Malades


type: Other Grant/Funding Number

title: Exercise and Myopathies. Physical Training Introduction in Lifestyle of Facioscapulohumeral Dystrophy Patients: Functional, Tissue and Quality of Life Benefits.

summary: It is now accepted that physical activity is not deleterious in myopathies, including muscular dystrophies. In patients suffering from facioscapulohumeral dystrophy (FSHD), aerobic training has been reported to be associated to physiological and functional positive effects without alteration in quality of life. The review papers from Van der Kooi et al. (2005), Cup et al. (2007) and Féasson et al. (2010) suggest that the combination of endurance and strength training is even more relevant. Only a few controlled and randomized studies have been conducted on this topic. The impact of such training programs on the skeletal muscle regenerative capacities has not been yet addressed. Moreover, due to the fact that training programs are mainly performed on short-term supervised periods, there is a lack of knowledge regarding long-term effects, patient's autonomy and whether or not regular exercise practice can be maintained in patient's daily life. Also, only a few experiments have reported an integrative view of the potential benefits of such programs on functional, biological and quality of life.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU de Grenoble
CHU de Saint-Etienne


title: Glucose Tolerance in Patients With an Idiopathic Parkinson's Disease

summary:
Dysfunction of autonomic nervous system is an important non motor feature of Parkinson' disease (PD). Lewy body formation is widely distributed in hypothalamus and in sympathetic and parasympathetic systems. Animal studies suggest a link between hypothalamus sensing of substrates and glucose metabolism. Thus, hypothalamus lesions could lead to change in glucose metabolism. Recently, we showed that fasting blood glucose level was significantly higher in PD patients than in control group suggesting that glucose tolerance may be impaired in PD. Some studies provided evidence for higher diabetes prevalence in PD patients whereas others showed no difference or a reduced risk of diabetes prevalence in PD patients compared to healthy subjects.

So, the risk that a PD patient develops a glucose intolerance or a diabetes is not clearly established and merit to be studied considering the damageable consequences for patient healthy.

The aim of this prospective study was to determine the risk that a PD patient develop a glucose intolerance or a diabetes compared to a matched control group, using an oral glucose tolerance test (OGTT).

ReferenceCitation: Marques A, Beze S, Pereira B, Chassain C, Monneyron N, Delaby L, Lambert C, Fontaine M, Derost P, Debilly B, Rieu I, Lewis SJG, Chiambaretta F, Durif F. Visual hallucinations and illusions in Parkinson's disease: the role of ocular pathology. J Neurol. 2020 Oct;267(10):2829-2841. doi: 10.1007/s00415-020-09925-x. Epub 2020 May 23.

family: Marques

full_name: Ana Marques

given: Ana

family: Beze

full_name: Steven Beze

given: Steven

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Chassain

full_name: Carine Chassain

given: Carine

family: Monneyron

full_name: Nathalie Monneyron

family: Delaby

full_name: Laure Delaby

given: Laure

family: Lambert

full_name: Celine Lambert

given: Celine

family: Fontaine

full_name: Marie Fontaine

given: Marie

family: Derost

full_name: Philippe Derost

given: Philippe

family: Debilly

full_name: Bérengère Debilly

given: Bérengère

family: Rieu

full_name: Isabelle Rieu

given: Isabelle

family: Lewis

full_name: Simon J. G. Lewis

given: Simon J. G.

family: Chiambaretta

full_name: Frédéric Chiambaretta

given: Frédéric

family: Durif

full_name: Franck Durif

given: Franck

journal_name: Journal of Neurology

title: Visual hallucinations and illusions in Parkinson’s disease: the role of ocular pathology

ReferenceCitation: Marques A, Dutheil F, Durand E, Rieu I, Mulliez A, Fantini ML, Boirie Y, Durif F. Glucose dysregulation in Parkinson's disease: Too much glucose or not enough insulin? Parkinsonism Relat Disord. 2018 Oct;55:122-127. doi: 10.1016/j.parkreldis.2018.05.026. Epub 2018 May 31.

family: Dutheil

full_name: Frédéric Dutheil

family: Durand

full_name: Elodie Durand

given: Elodie

family: Mulliez

full_name: Aurélien Mulliez

given: Aurélien

family: Fantini

full_name: Maria Livia Fantini

given: Maria Livia

family: Boirie

full_name: Yves Boirie

given: Yves

location_facility:
Chu Clermont-Ferrand
CHU Clermont-Ferrand


title: Relevance of Plasma PCSK9 Concentration as a Biomarker in Acute Coronary Syndrome.

summary:
PCSK9 (Proprotein convertase subtilisin kexin type 9) plays a key role in LDL-cholesterol (LDLC) metabolism by inhibiting LDL receptor (LDLR) at post-transcriptional level. PCSK9 loss of function mutations are associated to decreased LDLC levels and a cardiovascular protection. In this context, the development of pharmacological inhibitors of PCSK9, in association with statins treatment, represents a major therapeutic issue for LDLC modulation. It was previously shown that PCSK9 plasmatic concentration correlated with plasmatic LDLC, TG and glucose concentrations. However, no data are available on predictive value of PCSK9 plasmatic level concerning coronary disease severity.

The main objective of this study is to determine whether plasmatic PCSK9 concentration is linked to coronary damage severity in patients with acute coronary syndrome.

location_facility:
Nantes University hospital
Nantes University Hospital


title: Comparison of the Effects of Aripiprazole and Risperidone on the Pattern of Brain Activation in Schizophrenic Patients During Emotional Tasks and With Reference to Controls

summary: After an initial screening visit, including an assessment of psychiatric disorders, patients stabilized on antipsychotic medication (aripiprazole or risperidone) for at least 6 weeks and control subjects will undergo an assessment using functional magnetic resonance imaging (fMRI) of the differences of patterns of brain activation during an emotional task

lead_sponsor: Qualissima

location_facility: Hôpital de la Conception - Service du Pr Dassa -147, boulevard Baille

location_facility: Sainte-Marguerite Hospital - Psychiatric service -Service du Pr Azorin - 270 boulevard de Sainte Marguerite


title: An Open-Label, Multicenter, Single Arm QT Interval Prolongation Study of Eribulin Mesylate (E7389) in Patients With Advanced Solid Tumors

summary: The purpose of this study is to assess whether eribulin mesylate (E7389) has an impact on the electrocardiogram (ECG) with focus on cardiac repolarization, as measured by QT/QTc interval as well as through a pharmacokinetic-pharmacodynamic (PK/PD) analysis.

lead_sponsor: Eisai Limited

location_facility:
Medicale
Service d'Oncologie


title: Target Volume With a Pressure Controlled Ventilator in Obesity Hypoventilation Syndrome With Persistent Oxygen Desaturations With Continuous Positive Airway Pressure

acronym: OVO

summary: The purpose of this study is to investigate the evolution of daytime partial pressure of carbon dioxide in the blood (PaCO2) after 6 weeks of noninvasive ventilation-pressure support ventilation (NIV-PSV) with target volume versus continuous positive airway pressure (CPAP) alone versus NIV-PSV.

status: Withdrawn

lead_sponsor: Breas Medical S.A.R.L.

location_facility: GH Pitié-Salpétrière - Service de pneumologie et réanimation


title: Cardiovascular Events at One Year of Patients Hospitalized for Critical Limb Ischaemia and Aspirin Resistant Using the VerifyNow®. Aspirin Resistance and Prognosis of Patients With Critical Limb Ischaemia

acronym: Aspirine

summary:
Acetylsalicylic acid (Aspirin, ASA) is the most widely prescribed drug used in primary and secondary prevention of cardiovascular disease. However, aspirin resistance has been described, mostly in cardiac patients and is an independent predictive factor for a poor survival. Two frequent conditions in patients with cardiovascular diseases, diabetes and hypercholesterolemia, are also considered as risk factors for aspirin resistance. Among patients with peripheral arterial disease, those with critical limb ischemia have the worst cardiovascular prognosis. At one year, 23% are dead, 25% have a major cardiovascular event and 25% have a major amputation (which can be combined). Aspirin resistance is poorly studied in these patients, and to our knowledge no study has been made to assess the prognosis value of aspirin resistance on cardiovascular outcomes in critical limb ischaemia patients.

Hospitalized critical limb ischaemia patients will be tested for aspirin resistance using the bed-side point of care VerifyNow®, and will be followed during one year, including death, fatal and non-fatal acute coronary syndromes, cardiac decompensation, stroke, and major amputation.

location_facility:
UH Bordeaux
UH Toulouse


title: The ITP-RITUX Cohort: An Observational Study on Rituximab Off-label Use for Immune ThrombocytoPenia.

acronym: ITP-RITUX

summary: The primary purpose of the study is to describe by a prospective observational study the serious adverse events occurring in patients treated off-label by rituximab for Immune Thrombocytopenia.

ReferenceCitation: Khellaf M, Charles-Nelson A, Fain O, Terriou L, Viallard JF, Cheze S, Graveleau J, Slama B, Audia S, Ebbo M, Le Guenno G, Cliquennois M, Salles G, Bonmati C, Teillet F, Galicier L, Hot A, Lambotte O, Lefrère F, Sacko S, Kengue DK, Bierling P, Roudot-Thoraval F, Michel M, Godeau B. Safety and efficacy of rituximab in adult immune thrombocytopenia: results from a prospective registry including 248 patients. Blood. 2014 Nov 20;124(22):3228-36. doi: 10.1182/blood-2014-06-582346. Epub 2014 Oct 7.

name: Service de Médecine Interne, Centre de Référence Labellisé des Cytopénies Auto-Immunes de l’Adulte and

family: Khellaf

full_name: Mehdi Khellaf

given: Mehdi

name: Unité de Recherche Clinique, Centre Hospitalier Universitaire Henri-Mondor, Assistance Publique-Hôpitaux de Paris, Université Paris Est Créteil, Créteil, France;

family: Charles-Nelson

full_name: Anaïs Charles-Nelson

given: Anaïs

name: Service de Médecine Interne, Hôpital Jean-Verdier, Assistance Publique-Hôpitaux de Paris, Université Paris XIII, Bondy, France;

family: Fain

full_name: Olivier Fain

given: Olivier

name: Service de Médecine Interne, Centre Hospitalier Régional Universitaire de Lille, Lille, France;

family: Terriou

full_name: Louis Terriou

given: Louis

name: Département de Médecine Interne et Maladies Infectieuses, Centre Hospitalier Universitaire Haut Lévêque, Université de Bordeaux, Pessac, France;

family: Viallard

full_name: Jean-François Viallard

given: Jean-François

name: Service d’Hématologie Clinique, Centre Hospitalier Universitaire de la Côte de Nacre, Caen, France;

family: Cheze

full_name: Stéphane Cheze

given: Stéphane

name: Service de Médecine Interne, Centre Hospitalier Universitaire de Nantes, Nantes, France;

family: Graveleau

full_name: Julie Graveleau

given: Julie

name: Service d’Hématologie, Centre Hospitalier d’Avignon, Avignon, France;

family: Slama

full_name: Borhane Slama

given: Borhane

name: Service de Médecine Interne, Hôpital Le Bocage, Dijon, France;

family: Audia

full_name: Sylvain Audia

given: Sylvain

name: Service de Médecine Interne, Hôpital de La Conception, Assistance Publique-Hôpitaux de Marseille, Université Aix-Marseille, Marseille, France;

family: Ebbo

full_name: Mikael Ebbo

given: Mikael

name: Service de Médecine Interne, Centre Hospitalier Universitaire Estaing, Clermont Ferrand, France;

family: Le Guenno

full_name: Guillaume Le Guenno

given: Guillaume

name: Département d’Hématologie, Groupe Hospitalier de l’Institut Catholique de Lille, Lille, France;

family: Cliquennois

full_name: Manuel Cliquennois

given: Manuel

name: Service d’Hématologie, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Pierre-Bénite, University Claude Bernard Lyon 1, Lyon, France;

family: Salles

full_name: Gilles Salles

given: Gilles

name: Service d’Hématologie, Centre Hospitalier Universitaire de Nancy, Nancy, France;

family: Bonmati

full_name: Caroline Bonmati

given: Caroline

name: Département d’Immuno-Hématologie, Centre Hospitalier Universitaire Louis Mourrier, Assistance Publique-Hôpitaux de Paris, Colombes, France;

family: Teillet

full_name: France Teillet

given: France

name: Service d’Immuno-Pathologie, Centre Hospitalier Universitaire Saint-Louis, Assistance Publique-Hôpitaux de Paris, Paris, France;

family: Galicier

full_name: Lionel Galicier

given: Lionel

name: Service de Médecine Interne, Groupement Hospitalier Edouard Herriot, Lyon, France;

family: Hot

full_name: Arnaud Hot

given: Arnaud

name: Service de Médecine Interne, Centre Hospitalier Universitaire Bicêtre, Assistance Publique-Hôpitaux de Paris, Paris, France;

family: Lambotte

full_name: Olivier Lambotte

name: Service d’Hématologie, Centre Hospitalier Universitaire Necker, Assistance Publique-Hôpitaux de Paris, Paris, France;

family: Lefrère

full_name: François Lefrère

given: François

family: Sacko

full_name: Salimatou Sacko

given: Salimatou

family: Kengue

full_name: Dieudonné Kilendo Kengue

given: Dieudonné Kilendo

name: Etablissement Français du Sang, Henri-Mondor, Creteil, France; and

family: Bierling

full_name: Philippe Bierling

name: Service de Santé Publique, Centre Hospitalier Universitaire Henri-Mondor, Assistance Publique-Hôpitaux de Paris, Université Paris Est Créteil, Créteil, France

family: Roudot-Thoraval

full_name: Françoise Roudot-Thoraval

given: Françoise

family: Michel

location_facility: National Reference Center for the Study of Auto Immune Cytopenia


title: Assessment of the FLOTRAC/VIGILEO Third Generation Software to Predict Fluid Responsiveness in Critically Ill Patient With Acute Circulatory Failure

acronym: FLOVAC

summary: Acute circulatory failure may be related to hypovolemia. Fluid loading increases stroke volume in approximatively half of challenges. Determining fluid responsiveness prevents unnecessary fluid loading. Passive leg raising (PLR) provides a transient increase of 300 ml in venous return for a short time. The measurement of stroke volume (SV) before and after a PLR test allows physician to detect fluid responsiveness, when stroke volume increases is higher than 15 %. Beside thermodilution, the use of non invasive device to measure stroke volume becomes largely employed. Arterial Pressure based Cardiac Output (APCO), provided by the Flotrac/Vigileo system, does not required specific materials nor repeated calibration. The third generation software is believed to be more accurate and more precise for SV measurement. The aim of this study is to test the performance of the Flotrac/Vigileo device in a situation of rapid venous return changes induced by PLR and then by fluid loading. Patients will be classify posteriorly in responders and non responders, according to the magnitude of the fluid loading-induced SV changes measured by transthoracic echocardiography.

location_facility:
Hopital Paul Desbief
Hopital Ambroise Paré


title: Skin Fibrosis Analysis by Raman Spectroscopy in Systemic Sclerosis

acronym: RAMSES

summary:
Systemic sclerosis (SSc) is a rare connective tissue disease characterized by a high clinical heterogeneity with unpredictable evolution that could engage functional and life-threatening prognosis. Most of patients develop skin fibrosis gradually spreading. Two clinical distinct forms are described according to the extension of skin fibrosis: limited (lSSc) and diffuse (dSSc) SSc. It is now admitted that a spreading of skin fibrosis is associated with poor prognosis. This disease can be complicated by pulmonary arterial hypertension (PAH), interstitial lung disease (ILD) and scleroderma renal crisis (SRC) representing the main causes of death in SSc. Usually, PAH is associated with lSSc, and ILD and SRC are associated with dSSc. Prognosis is also different regarding skin phenotype with a higher mortality rate in dSSc.

An easy score, called modified Rodnan skin score, is commonly used in clinical practice to evaluate the spreading and severity of skin fibrosis, but this score is hardly reproducible. Ultrasound can be used to measure skin thickness and is more reproducible than the Rodnan skin score. Nevertheless, non-invasive analysis of fibrosis composition in different areas is not possible with these two technics.

Thus, in this study we will investigate Raman spectroscopy, a non-invasive technic based on the interaction of a low-intensity laser with matter.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: CHU de Reims


title: Exenteration: Quality of Life Study and Rehabilitation Rate According to the Reconstruction Technique

acronym: ETRE

summary:
Prospective monocentric quality of life study. Including all patients who have been exentered at the Institut Curie Paris, from January 2004 to December 2019, proposing to compare the reported quality of life of patients according to the reconstruction technique they have undergone.

The sponsor will evaluate the quality of life of our patients by means of two validated questionnaires, in French, in the context of ENT surgery: the FACT-G and FACT-MBIS questionnaires.

status: Recruiting

time_perspective: Retrospective

lead_sponsor: Institut Curie


title: Impact of Iron Deficiency on the Incidence of Postoperative Infections - CARIPO Observational Study

acronym: CARIPO

summary: Iron deficiency is a common state during the perioperative period. Data from literature do not allow us to conclude on how perioperative iron deficiency influences postoperative infections occurrence. This prospective observational study aims to assessed the postoperative infections incidence according to the preoperative iron-stock status.

lead_sponsor: University Hospital, Angers


title: Acceptability, Representations and Experiences of the COVID-19 Pandemic : the ARECOVID Project

acronym: ARECOVID

summary: The "ARECOVID" project is a comprehensive sociological study of what is being played out in organizational terms in the face of the COVID-19 pandemic. Through quantitative methods (questionnaires) and qualitative methods (semi-directive interviews), we would understand the essential views of the populations concerned by COVID-19, but also that of actors taking care of vulnerable elderly non-COVID. Special attention will be paid to the care pathway of elderly people with and without the virus, in a health system in full reorganization. We will try to understand the needs and experiences of all health actors (hospital/city) involved in COVID-19 and the experience of confinement and the Covid-19 of the elderly living at home, in order to reflect on a possible improvement in the health response of elderly people in the event of an epidemic health crisis.


title: Use of Cemented TFNA Nail Augmentation in the Treatment of Trochanterian Rock Fractures in Patients Over 65 Years of Age

acronym: TFNA

summary:
Intramedullary nailing is the standard treatment of trochanteric fractures. Mechanical failure such as cut-out and cut-through are associated with high rates of revision surgery, functional impairment and mortality. Augmentation of the implant have shown encouraging results in reducing the number of mechanical failures. The aim of the study was to evaluate the rate of mechanical failure of the cement augmented screws of TFNA nails.

A descriptive, retrospective, multi-operator, single-centre study was performed at our level 1 trauma centre. Patients were included if they were > 65 years of age, presented with a trochanteric fracture treated with an augmented TFNA nail. The primary outcome was fixation failure rate (cut-out or cut-through) at 3 and 6 postoperative months. Secondary endpoints were intraoperative data, clinical scores, and radiographic analysis.

ipd_sharing_description: All collected data that underlie results in a publication.

lead_sponsor: University Hospital, Brest


title: Prospective Cohort Study of Patients With Infective Endocarditis Admitted at Cardiology Institute of Pitié-Salpêtrière Hospital

acronym: EIPSL

summary:
Infective endocarditis (IE) is a severe condition associated with high mortality. Due to the relative low prevalence of IE, prospective data are lacking and current guidelines are mostly based on expert consensus with low level of evidence. IE is also associated with severe complications especially strokes that occur in about one third of the patients.

In order to improve the management and the prognosis of IE, clinical data from larges prospective cohort studies are needed.

location_facility: APHP Pitié-Salpêtrière Hospital, Department of Cardiology


title: Oral Health and Pregnancy : Relation Between Knowledge, Practices and Social Representation of Pregnant Women in the Gynecologie Department at the Montpellier's CHRU

acronym: OHAP

summary: The aim of this study is to identify the knowledge, behavior and social representation on dental health among pregnant women. This study could improve, in the future, prevention, treatments and care for them.

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Detection, Evaluation and Monitoring of Frailties in the Elderly

acronym: FRAGING

summary:
The aging of the French population is a major public health issue. Frailty is a reversible clinical state between optimal healthy aging and pathological aging. Early detection of frailty makes it possible to identify people aged 65 or over who are at risk of developing or worsen dependency and to offer them appropriate medical and/or social care adapted to their needs. The multidimensional screening program known as "ICOPE" (for "Integrated Care of Older People") promoted by the World Health Organization (WHO) aims to prevent functional decline worldwide and improve the well-being of older people. To support healthy aging, 6 intrinsic abilities are to be screened according to ICOPE: visual impairment, hearing impairment, depressive symptoms, locomotor abilities, cognitive decline and vitality. This program is intended to be developed in each country and adapted to the territories of action. The Mauriac and Vichy community health basins have a proportion of elderly people (≥60 years old) that is much higher than regional and national data, justifying the regional and national data, justifying the chosen action territories. The epidemiological characteristics of the French population and of the action territory made it possible to add to the following themes to the ICOPE recommendations: socio-economic situation, assistance to caregivers, vaccinations, drug iatrogeny, alcohol consumption, cardiovascular risk and cancer screening. The ICOPE process is organized in 5 steps: a community screening and a relay to the general practitioner to ensure a follow-up, an primary care in case of abnormality, evaluated at 3 months and then 6 months, establishment of a plan of care if necessary, possible referral to a specialist and mobilization of community resources mobilization of community resources and support for caregivers if needed.

The hypothesis is that conducting a fragility screening in a rural area (Mauriac health (Mauriac health basin) and a semi-urban area (Vichy health basin) would allow an effective would allow an effective allocation of expenses. In more detail, the costs are direct medical, direct non-medical, indirect and intangible costs, and efficiency is measured by measured by the quality of life score (LEIPAD). The hypothesis is that the early detection of people's frailties and their management improves their quality of life

primary_purpose: Screening

lead_sponsor: University Hospital, Clermont-Ferrand


title: Unplanned-extubation in the Intensive Care Unit; Incidence, Characteristics and Prognosis.

acronym: SAFE-ICU

summary: Our study consists of a national observational study assessing quantitatively (incidence) and qualitatively unscheduled extubation in intensive care unit. In addition, we will compare the outcome of patients with "success" or "failure" in the self-extubation subgroup.

lead_sponsor: Société Française d'Anesthésie et de Réanimation

location_facility: Hôpital La Pitié Salpêtrière- Département d'Anesthésie-Réanimation


title: A Prospective Pilot Study to Assess the Efficacy of Botox-A in Patients With Low Anterior Resection Syndrome (LARS>20) and Refractory Medical Treatment After Rectal Resection

acronym: BOTOX-TME

summary: After rectal resection for cancer (with or without stoma), patients may have digestive sequelae. LARS (Low Anterior Resection Syndrome) includes bowel frequency, stool fragmentation, urgency, and faecal incontinence. The goal of this study is to test intra-rectal BOTOX-A on functional outcomes and quality of life of patients with LARS refractory to medical treatment at 3 months after surgery.

lead_sponsor: University Hospital, Bordeaux


title: Analysis of Respiration-induced Deformations in Visceral and Renal Arteries Before and After Stenting During Branched Stent Treatment.

acronym: BEVAR

summary: Aneurysm of the abdominal aorta is defined by a loss of parallelism of the arterial wall. The main risk of this pathology is the rupture of the aneurysm which is life threatening and this risk increases with the size of the aneurysm. Connected stents allow the management of complex thoracoabdominal aneurysms in patients at high surgical risk and/or contraindicated for open surgery. These endovascular techniques have demonstrated their safety and efficacy, however, long-term CT follow-up remains essential to detect complications such as endo-leaks and restenosis/thrombosis of visceral and renal stents. The prognostic factors of these complications remain poorly elucidated. The type of stent to be used could be an explanation, however, no stent has been proven to be superior in this application to date. Data from the literature suggest an influence of stents on the aortic geometry and the arterial axes of the digestive tract during respiratory movements. The work of the Stanford vascular surgery team shows that the deformations and modifications of the geometry of these stents induced by the respiratory cycle could have a negative impact by migration, stenosis and thrombosis.

lead_sponsor: Centre Chirurgical Marie Lannelongue


title: Oral Health and Diabetes: Relationship Between Knowledge, Practices and Oral Health Status in Patients Followed in the Diabetes Department at the Montpellier University Hospital.

summary: The aim of this study is to assess the state of knowledge and practices in oral health of diabetic patients through the use of two questionnaires. It is also to analyse the link between the oral health status and the profile of diabetic patient, by carrying out an oral assessment for voluntary patients.


title: Systematic Screening for Primary Immunodeficiencies in Patients Admitted for Severe Infection in Pediatric Intensive Care Unit

acronym: SPYSI

summary:
Severe infections in pediatric intensive care unit are not uncommon. Historically, the diagnosis of hereditary (primary) immune deficiency required a combination of recurrent clinical signs and biological stigmas. This paradigm is currently being questioned, and grows the hypothesis of a potential underlying genetic susceptibility in any severe infection. To date, the proportion of severe infections explained by an underlying immune deficiency is unknown.

The aim of this prospective study is to assess the incidence of primary immune deficiencies in children with severe infection, regardless of their etiology.


title: A 24-month Real Life PErsistence Efficacy and Safety Study in IBD Patients in REMission Switched From Intravenous Infliximab to Subcutaneous Infliximab CT-P13 Remsima®SC

acronym: PEREM

summary:
Descriptive: A 24-month multicentre, observational, prospective cohort study. Population: IBD Patients under stable clinical and biological remission Study treatments: Patients who will be proposed to switch, or who have just switched, from the intravenous originator Remicade® or one of its biosimilars to the subcutaneous infliximab Remsima®SC as part of routine care. All consecutive patients in IBD centers participating in the study will be proposed to participate in the study during their regular outpatients' visits.

Objectives:The primary objective of PEREM study is to determine the rate of persistence of subcutaneous infliximab at 48 weeks after switching from IV infliximab to subcutaneous infliximab Remsima®SC.

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives


title: Study of the Composition and Bacterial Diversity of the Vaginal Microbiota in Healthy Versus Pathological Conditions (Bacterial Vaginosis) Using a Targeted Metagenomic Approach (RNA 16s)(CEBAM)

acronym: CEBAM

summary: It aims to determine and compare the degree of vaginal bacterial alpha diversity in the absence (healthy population) or presence of bacterial vaginosis (pathological population).

lead_sponsor: Larena SAS

intervention_type: Diagnostic Test


title: Factors Predicting the Duration of Effectiveness of Viscosupplementation in Knee Arthosis

acronym: PRESAGE

summary:
Knee osteoarthritis is a frequent condition whose prevalence is estimated at 7.6% of the French population aged 40 to 75, or approximately 2 million individuals . Viscosupplementation (VS) is a symptomatic treatment of knee osteoarthritis recommended by a large number of learned societies. It consists of the intra-articular injection (IA) of hyaluronic acid (HA), to reduce knee pain by restoring normal joint homeostasis impaired by endogenous HA deficiency.

The IA administration of HA can be performed using 2 protocols: repeated weekly injections (3, sometimes 5 injections) and single injections. To date and there is no argument to favor either protocol. Regardless of the formula used, the safety of HA is excellent (RR of adverse reaction versus saline = 1.01, 95% CI 0.96-1.07, P = 0.6). The indication for viscosupplementation is the symptomatic treatment of mild to moderate knee osteoarthritis after failure and / or intolerance of analgesics or nonsteroidal anti-inflammatory drugs (NSAIDs). In this indication, after HA injection the responder rate is in the order of 70% to 75% at 6 months and approximately 50% at 12 months. However, the predictors of the duration of effectiveness of SV are still unknown. The objective of the study is to research the factors influencing the duration of the effectiveness of SV, under real life conditions.

lead_sponsor: Hopital Nord Franche-Comte