title: Evaluation of Predictive Factors for Ruptures of Meije Duo ™ Size 1 and 2 Femoral Stems in Hip Replacement Surgery

acronym: MEIJE

summary:
A normative development concerning the mechanical resistance tests of the the femoral stems led to contraindicate, in September 2014, to implant Meije Duo ™ femoral stems size 1 or 2 in patients weighing more than 60 kg due to an assumed risk of femoral stem breakage.

This contraindication is based on standardized mechanical tests which may have not taken into account the changes in patient weight that may occur after the intervention.

To date, investigators have not been aware of any Meije Duo ™ size 1/2 brakeage in our patients implanted with this type of prosthesis regardless of their weights before 2014. However, it is possible that some of them have had a prostheses failure and consulted another hospital. In the absence of a clinical study on this problem, investigators decided to set up a health care assessment study collecting retrospective and prospective information from our patients.

primary_purpose: Health Services Research

ReferenceCitation: Wroblewski BM, Siney PD, Fleming PA. Increasing patients' body mass. Are the criteria for testing stemmed femoral components in total hip arthroplasty still valid? Proc Inst Mech Eng H. 2007 Nov;221(8):959-61.

ReferenceCitation: Silva M, Shepherd EF, Jackson WO, Dorey FJ, Schmalzried TP. Average patient walking activity approaches 2 million cycles per year: pedometers under-record walking activity. J Arthroplasty. 2002 Sep;17(6):693-7.

ReferenceCitation: Westerman AP, Moor AR, Stone MH, Stewart TD. Hip stem fatigue: : The implications of increasing patient mass. Proc Inst Mech Eng H. 2018 May;232(5):520-530. doi: 10.1177/0954411918767200. Epub 2018 Apr 2.

name: School of Mechanical Engineering, Faculty of Engineering, University of Leeds, Leeds, UK

family: Westerman

full_name: Ashley P Westerman

given: Ashley P

family: Moor

full_name: Andrew R Moor

given: Andrew R

name: Joint Replacement Technologies Group, Leeds Biomedical Research Centre, Leeds, UK

name: Department of Orthopaedics, Chapel Allerton Hospital, Leeds, UK

family: Stone

full_name: Martin H Stone

given: Martin H

family: Stewart

full_name: Todd D Stewart

given: Todd D

journal_name: Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine

oa_host_type: repository

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

lead_sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon

location_facility: Groupe Hospitalier Diaconesses Croix saint Simon

location_facility: Groupe Hospitalier Dianconesses croix saint Simon


title: Carriage Clearance of Emerging Highly Resistant Bacteria in Chronic Dialysis Patients

acronym: DIACOBHR

summary:
The propias, and more recently the update of the recommendations relating to the control of the spread of bacteria highly resistant to emerging antibiotics issued by the High Council of Public Health (December 2019), recommend the implementation of measures to maintain the rate of Carbapenemase-producing Enterobacteriaceae (EPC) such as Klebsiella pneumoniae (K. pneumoniae) isolated from bacteremia in healthcare establishments in France at less than 1%, and that of Vancomycin Resistant Enterococcus (VRE) belonging to Enterococci Resistant to Glycopeptides (ERG) such as Enterococcus faecium isolated from bacteremia in health establishments in France at less than 1% also. At the same time, the prevalence of colonized patients is increasing. One of the recommended measures concerns the fight against cross transmission.

Due to the high technicality of the treatments, the risks of cross-transmission are very high and present at each stage of the dialysis procedure. Screening and isolation of patients colonized with emerging Highly Resistant Bacteria (BHRe) is essential to avoid their spread and the risk of infection with these germs.

Screening is done using rectal swabs. If the patient is found to be a carrier of BHRe, he should be isolated. Isolation is made more difficult in the hemodialysis room due to their architectural configuration, the organization of care and the chronicity of the patients. Patients have a monthly sample.

The isolation is allowed after obtaining six consecutive negative rectal swabs, the number of which has been arbitrarily defined. Indeed, the negativation of the samples does not confirm the disappearance of the carriage (that is to say the presence of BHRe), hence the need to repeat them. Persistence of colonization at a rate below the detection limit is possible. With for corollaries:

Isolation which could be lifted more quickly in the event of real disappearance of the strain since the investigators know that a prolonged period of isolation can lead to a loss of opportunity for the patient and the investigators know its impact for the patient, on the operation of the service and its cost, with in particular the increase in withdrawals.
Isolation lifted too early in the event of persistent carriage with risk of secondary transmission.

The interest of this study is to determine the clearance of the carriage of BHRe, i.e. their disappearance, in the chronic dialysis patient and to define, secondly, the factors associated with the prolonged carriage corresponding to the presence of bacteria for more than 3 months. , and elements of answer concerning the early disappearance of the EPC in the event of co-colonization by ERG and EPC. The follow-up of this carriage for 1 year will make it possible to evaluate the relapse corresponding to the reappearance of the bacteria previously identified, the recolonization corresponding to the acquisition of a new BHR, or the reinfection corresponding to an infection with a new highly resistant bacterium.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Other

enrollment_type: Anticipated

ReferenceType: result

ReferenceCitation: Fournier S, Brossier F, Fortineau N, Gillaizeau F, Akpabie A, Aubry A, Barbut F, Chedhomme FX, Kassis-Chikhani N, Lucet JC, Robert J, Seytre D, Simon I, Vanjak D, Zahar JR, Brun-Buisson C, Jarlier V. Long-term control of vancomycin-resistant Enterococcus faecium at the scale of a large multihospital institution: a seven-year experience. Euro Surveill. 2012 Jul 26;17(30). pii: 20229.

ReferenceCitation: Davido B, Moussiegt A, Dinh A, Bouchand F, Matt M, Senard O, Deconinck L, Espinasse F, Lawrence C, Fortineau N, Saleh-Mghir A, Caballero S, Escaut L, Salomon J. Germs of thrones - spontaneous decolonization of Carbapenem-Resistant Enterobacteriaceae (CRE) and Vancomycin-Resistant Enterococci (VRE) in Western Europe: is this myth or reality? Antimicrob Resist Infect Control. 2018 Aug 13;7:100. doi: 10.1186/s13756-018-0390-5. eCollection 2018.

family: Davido

full_name: Benjamin Davido

given: Benjamin

sequence: first

family: Moussiegt

full_name: Aurore Moussiegt

given: Aurore

sequence: additional

family: Dinh

full_name: Aurélien Dinh

given: Aurélien

family: Bouchand

full_name: Frédérique Bouchand

given: Frédérique

family: Matt

full_name: Morgan Matt

given: Morgan

family: Senard

full_name: Olivia Senard

given: Olivia

family: Deconinck

full_name: Laurene Deconinck

given: Laurene

family: Espinasse

full_name: Florence Espinasse

given: Florence

family: Lawrence

full_name: Christine Lawrence

given: Christine

family: Fortineau

full_name: Nicolas Fortineau

given: Nicolas

family: Saleh-Mghir

full_name: Azzam Saleh-Mghir

given: Azzam

family: Caballero

full_name: Silvia Caballero

given: Silvia

family: Escaut

full_name: Lelia Escaut

given: Lelia

family: Salomon

full_name: Jérome Salomon

given: Jérome

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Antimicrobial Resistance & Infection Control

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

host_type: repository

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: publishedVersion

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Zahar JR, Garrouste-Orgeas M, Vesin A, Schwebel C, Bonadona A, Philippart F, Ara-Somohano C, Misset B, Timsit JF. Impact of contact isolation for multidrug-resistant organisms on the occurrence of medical errors and adverse events. Intensive Care Med. 2013 Dec;39(12):2153-60. doi: 10.1007/s00134-013-3071-0. Epub 2013 Aug 31.

family: Zahar

full_name: J. R. Zahar

given: J. R.

family: Garrouste-Orgeas

full_name: M. Garrouste-Orgeas

given: M.

family: Vesin

full_name: A. Vesin

given: A.

location_facility:
AURA Paris Site de Saint Ouen
AURA Corentin Celton
AURA Paris Plaisance
AURA Bichat
Groupe Hospitalier Paris Saint-Joseph


title: Underreporting of Occupational Blood Exposure (OBE) Among Medical Staff at an University Hospital Center (UHC) in 2017

summary: Regarding 30 to 50% of occupational blood exposure (OBE) are underreporting among health professionals, it's to highlight that the part of medical professionals in OBE reporting is among the lowest (1996 to 2016). The current study is aiming to evaluate the underreporting of this specific occupational accident among medical staff for the year 2017. The investigators are supposing this is declining and the part of OBE reporting is better than before. So the current situation concerning OBE underreporting for medical staff in an University Hospital Center (UHC), 20 years after the first study, is our main purpose.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Cross-Sectional

enrollment_type: Actual

lead_sponsor: Hospices Civils de Lyon

location_facility:
CHU Grenoble Alpes
Groupement Hospitalier Sud
CHU de Saint-Etienne
CHU Clermont-Ferrand

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Prospective, Controlled, Multicenter Cohort Study Evaluating the Benefit of Allogeneic Haematopoietic Stem Cells in Cutaneous T-cell Lymphomas Epidermotropic With Advanced Stage and Poor Prognosis

acronym: CUTALLO

summary: Epidermotropic T-cell lymphomas (ETCL), i.e. mycosis fungoides (MF) and its leukemic variant, Sézary syndrome, are the most frequent subtypes of cutaneous T-cell lymphomas. MF typically runs an indolent course in its early stages. By contrast, advanced-stage ETCLs share a very bad prognosis: Patients usually show early relapses after chemotherapy, prolonged complete remissions exceptionally occur and quality of life is severely affected. Several publications have reported durable responses following allogeneic hematopoietic stem cell transplantation (HSCT) in advanced-stage ETCLs. This study aims to investigate the role of allogeneic HSCT in treating advanced-stage ETCLs. An observational, prospective, multicenter, controlled study will compare the outcomes of patients who receive reduced-intensity conditioned allogeneic HSCT from a sibling or 10/10 HLA-matched unrelated donor to those of patients who receive standard of care in patients with advanced-stage ETCL with poor prognostic features, will be performed. Patients are included at the time of donor search irrespective of the results, and compared on a donor versus no donor basis. It is an observational study since no intervention is made except the comparison of outcomes of groups that receive usual care (HSCT if donor available, or not).

time_perspective: Prospective

lead_sponsor: Assistance Publique - Hôpitaux de Paris

status_simplified: Ongoing


title: Primary Prevention of Infections Related to Chambers Implantable Catheter by a Taurolodine Lock in Patients With Cancer Receiving Parenteral Nutrition

summary:
The therapeutic management of patients with cancer often requires the establishment of a chamber implantable catheter. Infections are the main complication of these catheters. These infections may be responsible for a significant impairment of quality of life for patients, and may increase the frequency and duration of hospitalizations. The rate of mortality from these infections is about 17%. The objective of this study is to evaluate the efficacy of a 1.35% taurolidine lock / 4% citrate (TauroLock®) in the primary prevention of infections related to chambers implantable catheter (IRCIC) in cancer patients receiving parenteral nutrition.

This is a, randomized, double-blind clinical trial comparing the incidence of IRCIC in patients receiving Taurolidine lock or concession the usual procedure of rinsing with saline (placebo) (pulsed rinsing with 20 mL of serum physiological and clamping catheter positive pressure). The lock will be instilled after the end of the session IV treatment (chemotherapy, parenteral nutrition, transfusion) before closing the catheter. The primary endpoint will be the rate IRCIC in both groups.

status: Unknown status

design_allocation: Randomized

primary_purpose: Prevention

location_facility:
Hôpital Edouard Herriot
Hôpital de la Croix Rousse
Groupement Hospitalier Lyon Sud

intervention_type: Device

status_simplified: Unknown


type: Other Identifier

title: Optimization of the Preservation of Muscle Mass and / or Its Recovery by a Protein-energy Chrononutrition Approach Dissociated From Meals

acronym: CARBOPTIMUS

summary:
Muscle wasting has a multifactorial origin, including decreased physical activity, malnutrition, loss of post-incident muscle recovery abilities, and decreased ability to regenerate muscle. Among the strategies tested to improve the production of proteins and thus muscle is the supplementation of whey proteins. However this strategy does not seem sufficient and optimal to avoid muscle wasting and it must be complemented by a complementary action.

Muscle protein degradation also occurs during the nocturnal fasting periods to provide amino acids for energy purposes and to produce glucose, essential for vital organs. The preservation of the benefit of whey intake during meals could therefore be optimized by reducing the use of muscle proteins for energy purposes during the night.

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
EHPAD Cité des Aînés
EHPAD Le Val Dorlay
EHPAD Le Soleil
EHPAD Les Myosotis
EHPAD Valbenoite
EHPAD Bernadette
Chu Saint-Etienne
EHPAD La Cerisaie
EHPAD Bellevue
EHPAD Les Tilleuls
EHPAD L'Adret

intervention_type: Dietary Supplement


title: Comparison of Efficacity of Simple Aspiration Versus Standard Drainage in the Management of Large Size Primary Spontaneous Pneumothorax

acronym: EXPRED

summary: Management of primary spontaneous pneumothorax (PSP) remains unclear. Primary therapeutic goals for PSP include removal of air from the pleural space an prevention of recurrences. The absence of generally accepted and methodologically sound recommendations may account for the extensive variation in practice for air evacuation techniques. Air evacuation may be achieved by simple aspiration (exsufflation) or conventional chest tube drainage. Chest tube thoracotomy remains the most popular technique.Aspiration is a more simple technique, that allows possibility of ambulatory management. The purpose of the present study is to compare simple aspiration performed with a specific thoracentesis device, versus conventional chest tube drainage. Comparison will be performed on immediate efficacity of resolution of the pneumothorax.The hypothesis is that simple aspiration performed with a specific device is not inferior to chest tube drainage for management of a first episode of large size primary spontaneous pneumothorax. A second goal is to measure the efficacy at one week, and the recidive at one year. The trial is randomized, controlled and will include 200 patients for each group. The patients will be enrolled in 29 hospitals in France. Emergency department, thoracic surgery and pulmonary departments of each hospital were primarily contacted for agreement to participate to the study.

primary_purpose: Treatment

ReferenceType: background

ReferenceCitation: Desmettre T, Meurice JC, Kepka S, Dalphin JC. [Treatment of first spontaneous pneumothorax: drainage or exsufflation?]. Rev Mal Respir. 2011 Jan;28(1):5-8. doi: 10.1016/j.rmr.2010.10.028. Epub 2011 Jan 12. Review. French.

ReferenceCitation: Desmettre T, Meurice JC, Mauny F, Woronoff MC, Tiffet O, Schmidt J, Ferretti G, Dalphin JC. [Comparison of simple aspiration versus standard drainage in the treatment of large primary spontaneous pneumothorax]. Rev Mal Respir. 2011 Mar;28(3):336-43. doi: 10.1016/j.rmr.2010.10.030. Epub 2011 Mar 10. French.

ReferenceCitation: Desmettre T, Meurice JC, Tapponnier R, Pretalli JB, Dalphin JC. [The EXPRED study: where are we?]. Rev Mal Respir. 2013 Jan;30(1):18-21. doi: 10.1016/j.rmr.2012.09.019. Epub 2012 Nov 13. French.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Intercommunal de la Haute Saône

intervention_type: Procedure


title: European Ambispective Cohort of Rectal Cancer Patient Who Underwent Robotic Low Anterior Resection

summary: The laparoscopic approach for total mesorectal excision (L-TME) results improved short-term outcomes. However this approach has technical limitations when the pelvis is narrow and deep. Indeed there is a limited mobility of straight laparoscopic instruments and associated loss of dexterity, unstable camera view and compromised ergonomics for the surgeon. Robotic technology was developed to reduce these limitations and offers the advantages of intuitive manipulation of laparoscopic instruments with wrist articulation, a 3-dimensional field of view, a stable camera platform with zoom magnification, dexterity enhancement and an ergonomic operating environment. A major advantage of the robotic approach is the surgeon's simultaneous control of the camera and of the two or three additional instruments. This advantage facilitates traction and counter-traction. The technological advantages of robotic surgery should also allow a finer dissection in a narrow pelvic cavity.

status: Active, not recruiting

ReferenceCitation: Green BL, Marshall HC, Collinson F, Quirke P, Guillou P, Jayne DG, Brown JM. Long-term follow-up of the Medical Research Council CLASICC trial of conventional versus laparoscopically assisted resection in colorectal cancer. Br J Surg. 2013 Jan;100(1):75-82. doi: 10.1002/bjs.8945. Epub 2012 Nov 6.

ReferenceCitation: van der Pas MH, Haglind E, Cuesta MA, Fürst A, Lacy AM, Hop WC, Bonjer HJ; COlorectal cancer Laparoscopic or Open Resection II (COLOR II) Study Group. Laparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes of a randomised, phase 3 trial. Lancet Oncol. 2013 Mar;14(3):210-8. doi: 10.1016/S1470-2045(13)70016-0. Epub 2013 Feb 6.

family: van der Pas

full_name: Martijn HGM van der Pas

given: Martijn HGM

family: Haglind

full_name: Eva Haglind

given: Eva

family: Cuesta

full_name: Miguel A Cuesta

given: Miguel A

family: Fürst

full_name: Alois Fürst

given: Alois

family: Lacy

full_name: Antonio M Lacy

given: Antonio M

family: Hop

full_name: Wim CJ Hop

given: Wim CJ

family: Bonjer

full_name: Hendrik Jaap Bonjer

given: Hendrik Jaap

journal_name: The Lancet Oncology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Rouanet P, Mourregot A, Azar CC, Carrere S, Gutowski M, Quenet F, Saint-Aubert B, Colombo PE. Transanal endoscopic proctectomy: an innovative procedure for difficult resection of rectal tumors in men with narrow pelvis. Dis Colon Rectum. 2013 Apr;56(4):408-15. doi: 10.1097/DCR.0b013e3182756fa0.

ReferenceCitation: Fernández-Hevia M, Delgado S, Castells A, Tasende M, Momblan D, Díaz del Gobbo G, DeLacy B, Balust J, Lacy AM. Transanal total mesorectal excision in rectal cancer: short-term outcomes in comparison with laparoscopic surgery. Ann Surg. 2015 Feb;261(2):221-7. doi: 10.1097/SLA.0000000000000865.

ReferenceCitation: Sylla P, Rattner DW, Delgado S, Lacy AM. NOTES transanal rectal cancer resection using transanal endoscopic microsurgery and laparoscopic assistance. Surg Endosc. 2010 May;24(5):1205-10. doi: 10.1007/s00464-010-0965-6. Epub 2010 Feb 26.

ReferenceCitation: Atallah S, Martin-Perez B, Albert M, deBeche-Adams T, Nassif G, Hunter L, Larach S. Transanal minimally invasive surgery for total mesorectal excision (TAMIS-TME): results and experience with the first 20 patients undergoing curative-intent rectal cancer surgery at a single institution. Tech Coloproctol. 2014 May;18(5):473-80. doi: 10.1007/s10151-013-1095-7. Epub 2013 Nov 23.

ReferenceCitation: D'Annibale A, Pernazza G, Monsellato I, Pende V, Lucandri G, Mazzocchi P, Alfano G. Total mesorectal excision: a comparison of oncological and functional outcomes between robotic and laparoscopic surgery for rectal cancer. Surg Endosc. 2013 Jun;27(6):1887-95. doi: 10.1007/s00464-012-2731-4. Epub 2013 Jan 5.

ReferenceCitation: Kwak JM, Kim SH, Kim J, Son DN, Baek SJ, Cho JS. Robotic vs laparoscopic resection of rectal cancer: short-term outcomes of a case-control study. Dis Colon Rectum. 2011 Feb;54(2):151-6. doi: 10.1007/DCR.0b013e3181fec4fd.

ReferenceCitation: Park JS, Choi GS, Lim KH, Jang YS, Jun SH. Robotic-assisted versus laparoscopic surgery for low rectal cancer: case-matched analysis of short-term outcomes. Ann Surg Oncol. 2010 Dec;17(12):3195-202. doi: 10.1245/s10434-010-1162-5. Epub 2010 Jun 30.

ReferenceCitation: Patel CB, Ragupathi M, Ramos-Valadez DI, Haas EM. A three-arm (laparoscopic, hand-assisted, and robotic) matched-case analysis of intraoperative and postoperative outcomes in minimally invasive colorectal surgery. Dis Colon Rectum. 2011 Feb;54(2):144-50. doi: 10.1007/DCR.0b013e3181fec377.

ReferenceCitation: Bianchi PP, Ceriani C, Locatelli A, Spinoglio G, Zampino MG, Sonzogni A, Crosta C, Andreoni B. Robotic versus laparoscopic total mesorectal excision for rectal cancer: a comparative analysis of oncological safety and short-term outcomes. Surg Endosc. 2010 Nov;24(11):2888-94. doi: 10.1007/s00464-010-1134-7. Epub 2010 Jun 5.

ReferenceCitation: Popescu I, Vasilescu C, Tomulescu V, Vasile S, Sgarbura O. The minimally invasive approach, laparoscopic and robotic, in rectal resection for cancer. A single center experience. Acta Chir Iugosl. 2010;57(3):29-35.

ReferenceCitation: Lin S, Jiang HG, Chen ZH, Zhou SY, Liu XS, Yu JR. Meta-analysis of robotic and laparoscopic surgery for treatment of rectal cancer. World J Gastroenterol. 2011 Dec 21;17(47):5214-20. doi: 10.3748/wjg.v17.i47.5214.

ReferenceCitation: Trastulli S, Farinella E, Cirocchi R, Cavaliere D, Avenia N, Sciannameo F, Gullà N, Noya G, Boselli C. Robotic resection compared with laparoscopic rectal resection for cancer: systematic review and meta-analysis of short-term outcome. Colorectal Dis. 2012 Apr;14(4):e134-56. doi: 10.1111/j.1463-1318.2011.02907.x. Review.

family: Trastulli

full_name: S. Trastulli

given: S.

family: Farinella

full_name: E. Farinella

given: E.

family: Cirocchi

full_name: R. Cirocchi

given: R.

family: Cavaliere

full_name: D. Cavaliere

given: D.

family: Avenia

full_name: N. Avenia

given: N.

family: Sciannameo

full_name: F. Sciannameo

given: F.

family: Gullà

full_name: N. Gullà

family: Noya

full_name: G. Noya

given: G.

family: Boselli

full_name: C. Boselli

given: C.

journal_name: Colorectal Disease

publisher: Wiley

publisher_dissemination: Wiley

ReferenceCitation: Memon S, Heriot AG, Murphy DG, Bressel M, Lynch AC. Robotic versus laparoscopic proctectomy for rectal cancer: a meta-analysis. Ann Surg Oncol. 2012 Jul;19(7):2095-101. doi: 10.1245/s10434-012-2270-1. Epub 2012 Feb 16.

ReferenceCitation: Yang Y, Wang F, Zhang P, Shi C, Zou Y, Qin H, Ma Y. Robot-assisted versus conventional laparoscopic surgery for colorectal disease, focusing on rectal cancer: a meta-analysis. Ann Surg Oncol. 2012 Nov;19(12):3727-36. doi: 10.1245/s10434-012-2429-9. Epub 2012 Jul 3.

title: Robot-Assisted Versus Conventional Laparoscopic Surgery for Colorectal Disease, Focusing on Rectal Cancer: A Meta-analysis

ReferenceCitation: González Fernández AM, Mascareñas González JF. [Total laparoscopic mesorectal excision versus robot-assisted in the treatment of rectal cancer: a meta-analysis]. Cir Esp. 2012 Jun-Jul;90(6):348-54. doi: 10.1016/j.ciresp.2012.03.004. Epub 2012 Apr 24. Spanish.

ReferenceCitation: Ortiz-Oshiro E, Sánchez-Egido I, Moreno-Sierra J, Pérez CF, Díaz JS, Fernández-Represa JÁ. Robotic assistance may reduce conversion to open in rectal carcinoma laparoscopic surgery: systematic review and meta-analysis. Int J Med Robot. 2012 Sep;8(3):360-70. doi: 10.1002/rcs.1426. Epub 2012 Mar 22. Review.

ReferenceCitation: Xiong B, Ma L, Zhang C, Cheng Y. Robotic versus laparoscopic total mesorectal excision for rectal cancer: a meta-analysis. J Surg Res. 2014 May 15;188(2):404-14. doi: 10.1016/j.jss.2014.01.027. Epub 2014 Jan 22.

ReferenceCitation: Son GM, Kim JG, Lee JC, Suh YJ, Cho HM, Lee YS, Lee IK, Chun CS. Multidimensional analysis of the learning curve for laparoscopic rectal cancer surgery. J Laparoendosc Adv Surg Tech A. 2010 Sep;20(7):609-17. doi: 10.1089/lap.2010.0007.

ReferenceCitation: Kim HJ, Choi GS, Park JS, Park SY. Multidimensional analysis of the learning curve for robotic total mesorectal excision for rectal cancer: lessons from a single surgeon's experience. Dis Colon Rectum. 2014 Sep;57(9):1066-74. doi: 10.1097/DCR.0000000000000174.

ReferenceCitation: Jiménez-Rodríguez RM, Díaz-Pavón JM, de la Portilla de Juan F, Prendes-Sillero E, Dussort HC, Padillo J. Learning curve for robotic-assisted laparoscopic rectal cancer surgery. Int J Colorectal Dis. 2013 Jun;28(6):815-21. doi: 10.1007/s00384-012-1620-6. Epub 2012 Dec 15.

ReferenceCitation: Kuo LJ, Lin YK, Chang CC, Tai CJ, Chiou JF, Chang YJ. Clinical outcomes of robot-assisted intersphincteric resection for low rectal cancer: comparison with conventional laparoscopy and multifactorial analysis of the learning curve for robotic surgery. Int J Colorectal Dis. 2014 May;29(5):555-62. doi: 10.1007/s00384-014-1841-y. Epub 2014 Feb 23.

ReferenceCitation: Baek JH, Pastor C, Pigazzi A. Robotic and laparoscopic total mesorectal excision for rectal cancer: a case-matched study. Surg Endosc. 2011 Feb;25(2):521-5. doi: 10.1007/s00464-010-1204-x. Epub 2010 Jul 7.

ReferenceCitation: Park YA, Kim JM, Kim SA, Min BS, Kim NK, Sohn SK, Lee KY. Totally robotic surgery for rectal cancer: from splenic flexure to pelvic floor in one setup. Surg Endosc. 2010 Mar;24(3):715-20. doi: 10.1007/s00464-009-0656-3. Epub 2009 Aug 18.

ReferenceCitation: Speicher PJ, Englum BR, Ganapathi AM, Nussbaum DP, Mantyh CR, Migaly J. Robotic Low Anterior Resection for Rectal Cancer: A National Perspective on Short-term Oncologic Outcomes. Ann Surg. 2015 Dec;262(6):1040-5. doi: 10.1097/SLA.0000000000001017.

ReferenceCitation: Tuech JJ, Karoui M, Lelong B, De Chaisemartin C, Bridoux V, Manceau G, Delpero JR, Hanoun L, Michot F. A step toward NOTES total mesorectal excision for rectal cancer: endoscopic transanal proctectomy. Ann Surg. 2015 Feb;261(2):228-33. doi: 10.1097/SLA.0000000000000994.

ReferenceCitation: Wolthuis AM, de Buck van Overstraeten A, D'Hoore A. Dynamic article: transanal rectal excision: a pilot study. Dis Colon Rectum. 2014 Jan;57(1):105-9. doi: 10.1097/DCR.0000000000000008.

ReferenceCitation: Dumont F, Goéré D, Honoré C, Elias D. Transanal endoscopic total mesorectal excision combined with single-port laparoscopy. Dis Colon Rectum. 2012 Sep;55(9):996-1001. doi: 10.1097/DCR.0b013e318260d3a0.

ReferenceCitation: Zorron R, Phillips HN, Coelho D, Flach L, Lemos FB, Vassallo RC. Perirectal NOTES access: "down-to-up" total mesorectal excision for rectal cancer. Surg Innov. 2012 Mar;19(1):11-9. doi: 10.1177/1553350611409956. Epub 2011 Jul 7.

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

location_facility: Institut régional du cancer de Montpellier


title: TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis

acronym: TOTEM-RRMS

summary:
Centra nervous system (CNF) damage in multiple sclerosis (MS), are mainly attributed to myelin destruction, axonal abnormalities and subsequent degeneration, and are responsible for serious deficiencies. Current therapies are focused on the treatment of inflammation with several types of anti-inflammatory agents. However, there is an urgent need for innovative therapies promoting neuroregeneration and particularly myelin repair.

It has been demonstrated that testosterone can act through neural androgen receptors to promote proliferation and differentiation of oligodendrocyte precursors into mature oligodendrocytes in a cuprizone-induced animal model of demyelination. The rare clinical trials on testosterone are mainly exploratory. Here, we sought to demonstrate an effect of testosterone supplementation in testosterone-deficient patients in a multicenter, randomized, parallel-group, double-blind, placebo-controlled phase 2 trial.

The main objective will be to determine the neuroprotective and remyelinating effects of testosterone using tensor diffusion imaging techniques and thalamic atrophy analyzes.

As secondary objectives, we would like to study the impact of testosterone supplementation on other conventional and unconventional MRI parameters and on clinical outcomes (cognition, fatigue, quality of life, impact on work / activity and anxiety / depression).

ReferenceType: derived

ReferenceCitation: Metzger-Peter K, Kremer LD, Edan G, Loureiro De Sousa P, Lamy J, Bagnard D, Mensah-Nyagan AG, Tricard T, Mathey G, Debouverie M, Berger E, Kerbrat A, Meyer N, De Seze J, Collongues N. The TOTEM RRMS (Testosterone Treatment on neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis) trial: study protocol for a randomized, double-blind, placebo-controlled trial. Trials. 2020 Jun 29;21(1):591. doi: 10.1186/s13063-020-04517-6.

family: Metzger-Peter

full_name: Katline Metzger-Peter

given: Katline

family: Kremer

full_name: Laurent Daniel Kremer

given: Laurent Daniel

family: Edan

full_name: Gilles Edan

given: Gilles

family: Loureiro De Sousa

full_name: Paulo Loureiro De Sousa

given: Paulo

family: Lamy

full_name: Julien Lamy

given: Julien

family: Bagnard

full_name: Dominique Bagnard

given: Dominique

family: Mensah-Nyagan

full_name: Ayikoe-Guy Mensah-Nyagan

given: Ayikoe-Guy

family: Tricard

full_name: Thibault Tricard

given: Thibault

family: Mathey

full_name: Guillaume Mathey

given: Guillaume

family: Debouverie

full_name: Marc Debouverie

given: Marc

family: Berger

full_name: Eric Berger

given: Eric

family: Kerbrat

full_name: Anne Kerbrat

given: Anne

family: Meyer

full_name: Nicolas Meyer

given: Nicolas

family: De Seze

full_name: Jérôme De Seze

given: Jérôme

family: Collongues

full_name: Nicolas Collongues

currency_apc_doaj: GBP

journal_name: Trials

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

lead_sponsor: University Hospital, Strasbourg, France

location_facility:
CHU Nancy
CHRU de Strasbourg
CHU de Rennes/Pontchaillou
CHU de Besançon

intervention_type: Behavioral


title: Apparent Life Threatening Events, Sudden Infant Death Syndrome and Muscarinic Receptors

acronym: iALTE

summary: Apparent Life-Threatening Events (ALTE) in infants often lead to severe neurological complications or to sudden death. In such situations, cardio-pediatricians and intensive care physicians have no specific diagnosis or treatment. In a recent translational research (INSERM-DHOS), our team has reported a myocardiac abnormality in a rabbit model of vagal hyperreactivity which is also present in the human hearts of infants deceased from sudden death, i.e. increased M2 muscarinic receptors (M2R) density associated with compensative increased enzymatic activity and overexpression of acetylcholine esterase (AchE). In a recent PHRC-I study (article in preparation), these abnormalities have also been observed in the blood of patients, infants as well as adults, exhibiting severe vagal syncopes. We observed, even more importantly, similar abnormalities in infants under 1 year of age with very severe idiopathic ALTE (iALTE) compared with normal subjects and with patients who presented ALTE with identified etiologies (JAMA Pediatric, 2016 May). The aim of this present study is to validate the overexpression of M2R as a marker of risk of iALTE in infant under 1 year.

primary_purpose: Basic Science

location_facility: Pediatric intensive care unit/ Pediatric unit- Strasbourg University Hospital - Hautepierre Hospital

location_facility: Pediatric unit - Maison Blanche Hospital - Reims University Hospital

location_facility: Pediatric Intensive Care unit/Emergency unit - Besançon University Hospital

location_facility: Pediatric Intensive Care Unit - Brabois Hospital - Nancy University Hospital

intervention_type: Biological


title: Interest Balance Auto-immune Population in Patients With Focal Epilepsy of Unknown Cause, Not Structural, Not Genetics, Newly Diagnosed

acronym: IBADEPIF

summary:
The knowledge of encephalitis associated with antibodies targeting intracellular antigens, and neuronal surface antibody syndromes has expanded considerably in recent times.

The primary purpose of the investigators protocole is to determine the incidence of anti-neuronal antibodies (blood and CSF) in a population of patients suffering from focal epilepsy of unknown cause to guide the management of these patients.

The investigators hypothesis is that dysimmune encephalitis is more common than is suggested by the current literature, and that sometimes forms of encephalitis dysimmune "at minimum" can be observed only in the form of focal epilepsy without further manifestation associated.

location_facility: Les Hôpitaux Universitaires de Strasbourg


title: Clinical Implication of the Molecular Diagnostic Retinitis Pigmentosa Molecular Diagnostic Using High Throughput Sequencing (RP-SEQ-HD)

acronym: RP-SEQ-HD

summary:
The retinitis pigmentosa (RP) are genetic conditions that cause retinal degeneration leading to severe low vision and is the leading cause of consultation in reference centers dedicated to the ophthalmic genetics. These rare diseases are characterized by a triple heterogeneity (clinical, genetic and molecular), which made them unreachable by traditional molecular diagnostic sequencing technology by the large number of genes to be tested (> 190).

The advent of high-throughput sequencing (NGS) and targeted capture has opened unexpected possibilities of investigation and ultimately to improve the care of patients. This project aims to study the genetic and molecular epidemiology of an interregional french (grand EST) cohort of patients. Patients receive a detailed retinal phenotype (visual acuity, visual field, photographs of the fundus and ERG). Their DNA will be analyzed by NGS targets the 190 known genes (https://sph.uth.edu/retnet/).

This research will provide a molecular epidemiological cohort study compared to prior publications on the frequency of genes involved. The benefit for patients is important to: establish a mode of transmission of the disease and optimize genetic counseling (currently very empirical); establish phenotype-genotype correlations in the French population (very few studies to date) and from the data of international literature; identify patients likely to be included in future therapeutic protocols of research; identify patients with significant potential for future projects to identify new genes.

The primary purpose of the protocol is to use high throughput sequencing to identify pathogenic variants in genes involved in RP.

The secondary purposes will be the following:

Determining the diagnostic yield
Study the genotype-phenotype correlation.

The secondary purposes will be the following:

Determining the diagnostic yield
Study the genotype-phenotype correlation

location_facility: Service d'Ophtalmologie, Hôpital Robert Debré, CHR

location_facility: Service d'Ophtalmologie CHU Hôpital Général

location_facility: Affections Rares en Génétique Ophtalmologique (CARGO) Hôpital Civil, Hôpitaux Universitaires de Strasbourg


title: Study of the Interactions Between Dientamoba Fragilis and the Gut Microbiota

summary: D.fragilis is an intestinal protozoon that feeds by phagocytosis of intestinal bacteria. The study aim to determine if the carriage of the intestinal parasite D.fragilis is associated to changes of gut microbiota in subjects presenting with or without intestinal symptoms.

status: Terminated

location_facility: Service d'hépato gastro-entérologie et assistance nutritive Hôpital Hautepierre

location_facility: Médecine interne, maladies tropicales et infectieuses Hôpital Civil

location_facility: Service de Médecine Interne - Diabète et Maladies métaboliques Hôpital Civil

location_facility: Laboratoire de Parasitologie et de Mycologie Médicale du Plateau Technique de Microbiologie des Hôpitaux Universitaires de Strasbourg


title: Impact of Starting a Dolutegravir-based Regimen on HIV-1 Proviral DNA Reservoir Of Treatment Naïve and Experienced Patients

acronym: DRONE

summary: This is a multi-center prospective study. The primary objective of DRONE study is to investigate the change of the size of HIV-1 DNA reservoir in blood from baseline to week 48 (W48) in participants treated by DTG-based regimen. Secondary objectives include: DTG pharmacokinetic and analysis of biomarkers of immune activation from baseline to W48.

location_facility: Centre hospitalier de Belfort-Montbéliard


title: Metabolomic Analysis of Systemic Sclerosis

acronym: SCLEROMICS

summary:
Currently investigators do not have diagnostic and prognostic markers for SSc which almost always starts with a vascular disease (Raynaud's disease) isolated for several years.

The primary purpose is to highlight discriminating metabolic profiles depending on the characteristics of the disease, allowing early diagnosis of SSc at the onset of vascular lesions, by comparing the profiles of SSc beginners (<3 years) to established forms (> 3 years).

Secondary purposes:

Prognosis: to study the metabolomics profile of SSc when a visceral complication occurs
Diagnosis: to compare the metabolomics profile of SSc to undifferentiated connective tissue disease (UCDT), Raynaud's disease (RD), vascular disease (VD) and healthy controls
Exploratory: to compare the metabolomics profile of blood, urine and skin of SSc patients

location_facility:
CHU
Hôpitaux privés de Metz


title: Protective Effects of Ischemic Preconditioning on Cardiac, Renal, Pulmonary and Muscular Functions After Aortic Clamping

summary: Open surgery for aneurysmal aortic disease can lead to cardiac, renal, pulmonary or muscular complications, essentially due to the aortic clamping. Ischemic preconditioning can be useful in order to decrease these complications. The investigators would like to use an ischemic preconditioning protocol during open surgery of aortic aneurysm in order to decrease these complications.

location_facility: Service de Chirurgie Vasculaire, CH Jean Minjoz

location_facility: Service de Chirurgie Vasculaire, CHU le Bocage

location_facility: Service de Chirurgie Vasculaire, Hôpitaux Privés de Metz, Site de Mercy

location_facility: Service de Chirurgie vasculaire et transplantation rénale, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg


title: Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding After Major Hepatectomy : a Prospective Randomized Double-blinding Study

summary: Blood loss was reported as a prognostic risk factor of morbidity and overall survival after hepatic resection. The aim of this study prospective randomized was compare the efficacy of the administration of tranexamic acid versus placebo to reduce perioperative bleeding after major hepatectomy (> 3 hepatic segments).

location_facility: Chirurgie Viscérale et transplantation, Hôpital de Hautepierre , CHU Strasbourg

location_facility: CHU de Bordeaux (Hôpital Haut- Lévêque et Hôpital Saint-André)

location_facility: Chirurgie digestive et transplantation, Hôpital de Besançon

intervention_type: Drug


title: Effects of Early Rehabilitation in Chronic Obstructive Pulmonary Disease Patients Under Mechanical Ventilation for Acute Respiratory Failure in Intensive Care Unit.

summary: Twenty per cent of the intensive care patients mechanically ventilated suffer from chronic obstructive pulmonary disease (COPD). These patients stay longer in Intensive Care which is more costly and they are more prone to nosocomial infection.In addition, they are longer bedridden and they develop muscular weakness.Prolonged inactivity results in respiratory and skeletal muscle weakness which curtails simple daily activity.The principal purpose of this study is to compare two types of muscular rehabilitation (electrical stimulation of the thigh and/or cycloergometer training) to classic passive mobilization of the leg.The second purpose is to analyse the effects of each type of rehabilitation on muscular fiber (structural and functional analysis) by muscular biopsies.Two hundred forty COPD patients admitted in the intensive care unit for acute respiratory failure will be randomized in 4: 1 fashion to receive passive mobilization of the legs(group 1, n=60), electrical stimulation of the thigh (group 2, n=60), cycloergometer training (group 3, n=60) or electrical stimulation of the thigh and cycloergometer training(group 4, n=60).The rehabilitation program will last 4 weeks with 5 sessions per week.In each group of patients, muscular biopsies will be done under local anaesthesia at the beginning and end of the rehabilitation programme and when they are discharged from the service.

location_facility: Service de Médecine Physique et de Réadaptation, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

location_facility: Service de Réanimation Médicale, Hôpital Civil, Hôpitaux Universitaires de Strasbourg

location_facility: Service des Explorations Fonctionnelles Respiratoires, Hôpital Civil, Hôpitaux Universitaires de Strasbourg

location_facility: Service de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg


title: Treatment of Severe Hypertension During Pre-Eclampsia.A Preliminary Equivalence Study Between URAPIDIL and NICARDIPINE

summary:
The aim of this study is to confirm that URAPIDIL is as efficient and as safe as NICARDIPINE to correct severe hypertension in pre-eclamptic patients.

efficacy endpoint : mean arterial blood pressure corrected to 105-125 mmHg after 120 min of study drug administration.
safety endpoints : clinical, biological and ultrasound observation for any side effect.All infants will be observed in the neonatology unit (during 48h).

ReferenceCitation: Diemunsch P, Garcia V, Lyons G, Pottecher J, Emmanuel S. Urapidil versus nicardipine in preeclamptic toxaemia: A randomised feasibility study. Eur J Anaesthesiol. 2015 Nov;32(11):822-3. doi: 10.1097/EJA.0000000000000303.

family: Diemunsch

full_name: Pierre Diemunsch

given: Pierre

family: Garcia

full_name: Vincent Garcia

given: Vincent

family: Lyons

full_name: Gordon Lyons

given: Gordon

family: Pottecher

full_name: Julien Pottecher

family: Emmanuel

full_name: Samain Emmanuel

given: Samain

journal_name: European Journal of Anaesthesiology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

location_facility: Service d'Anesthésie et de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg


title: Comparison of Cliavist Enhancement in Infectious and Degenerative Diseases of the Spine

summary: USPIO contrast enhancement results from intracellular trapping of the iron particles in reactive cells, especially macrophages. 17FDG-PET studies have demonstrated that macrophages are present in spine infectious diseases but are absent in spine degenerative diseases. The aim of this work is to compare the enhancement induced by CLIAVIST in both diseases. The absence of macrophages in degenerative lesions should help to differentiate them from infectious lesions, who should present contrast enhancement in relation to the presence of macrophages.

primary_purpose: Diagnostic

location_facility: Service de Neuroradiologie - Hôpital Central

location_facility: Service de Rhumatologie - Hôpital de Hautepierre

location_facility: Service de Radiologie 2 - Hôpital de Hautepierre


title: TWIST Human Gene and Cleft Lips and Palates

summary: This study uses a sequence analysis for TWIST and other craniofacial development genes, among patients presenting with facial clefting.

location_facility: Service de Consultation de la Face, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

location_facility: Centre d'Investigations Cliniques, Hôpital Civil, Hôpitaux Universitaires de Strasbourg

location_facility: Centre de Soins , d'Enseignement et de Recherche Dentaire (CESRD), Hôpital Civil, Hôpitaux Universitaires de Strasbourg

location_facility: Service de Chirurgie Infantile, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg


title: Prevention of Pneumococcal Infections: Impact Collaborative Medico-pharmaceutical Care Structured to Improve Vaccination Coverage of Patients at Risk.

acronym: OPTIVACC

summary: In France, Streptococcus pneumoniae is the leading agent bacterial involved in community lung disease and meningitis. The frequency of these infections and their mortality increase significantly in those at risk such as patients with certain chronic diseases, immunocompromised or on immunosuppressive therapy. This population, despite regular monitoring, has a limited pneumococcal vaccine coverage of around 20%. By carrying out a reconciliation of treatments upon admission to hospital, the clinical pharmacist can detect those without up to date pneumococcal vaccination status. The goal of this management is to make the patient aware of the need for vaccination and organization upon return home. Thus, this limited pneumococcal vaccination coverage would benefit from intervention by regional clinical pharmacy activities. The study investigators want to study the impact of a structured medico-pharmaceutical collaboration on pneumococcal vaccination of patients with risk on discharge from hospital. The investigators hypothesize that this collaboration in patients at risk of infection with pneumococcus could significantly increase their anti-pneumococcal vaccination coverage

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CH de Perpignan
CH Comminges Pyrénées
CH de Bagnols sur Cèze
CH du Bassin de Thau
CHU de Montpellier
CHU de Nimes
CH Alès Cévennes
CH de Montauban
CHU de Toulouse


title: Multicentre Prospective Cohort Study of Patients With Chronic Alcoholic and/or Metabolic Liver Disease

acronym: CALMET

summary:
Chronic alcoholic and metabolic liver diseases are the two main liver diseases in France. The long-term prognosis of these two diseases are not well known because main studies are retrospective and with only alcoholic patients. The knowledge of the natural history of these diseases should improve the management of patients with such diseases.

The aim of this prospective cohort is to describe the natural history of patients with chronic liver disease due to alcohol or metabolic disease and to identify factors associated with complications of these liver diseases (cirrhosis, hepatocellular carcinoma, ascites. ..).

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: CHU de Bordeaux - Hôpital du Haut-Lévêque

location_facility: CHRU de Strasbourg - Nouvel Hôpital Civil

location_facility: CHU de Brest - Hôpital La Cavale Blanche


title: Predicting Severe Toxicity of Targeted Therapies in Elderly Patients With Cancer

acronym: PreToxE

summary: In order to assess the important issue of the safety of antiangiogenic TKI in geriatric population we set up this project which aims to identify, among clinical, biological, pharmacokinetic data, predictive factors for severe toxicity of antiangiogenic TKI (sunitinib, sorafenib, pazopanib, regorafenib, axitinib) in patients over 70 year-old.

ReferenceCitation: Lebreton C, Cantarel C, Toulza E, Desgrippes R, Bozec L, Saada E, Ducoulombier A, Tardy M, Paillaud E, Lalet C, Bellera C, Italiano A. Incidence and prognostic factors of clinically meaningful toxicities of kinase inhibitors in older patients with cancer: The PreToxE study. J Geriatr Oncol. 2021 May;12(4):668-671. doi: 10.1016/j.jgo.2020.09.020. Epub 2020 Sep 23.

lead_sponsor: Institut Bergonié

location_facility:
Institut Bergonié
Centre Léon Bérard

lead_sponsor_type: industriel


title: Assessment of the Comparative Effect of Donepezil 10mg/d and Placebo on Clinical and Radiological Markers in Patients With Mild Cognitive Disorders

summary: The purpose of this study is to demonstrate that donepezil slows the progression of Alzheimer's disease (AD) using magnetic resonance imaging (MRI) of the brain to measure the volume of the hippocampus in patients with pre-dementia Alzheimer's disease.

ReferenceCitation: Cavedo E, Dubois B, Colliot O, Lista S, Croisile B, Tisserand GL, Touchon J, Bonafe A, Ousset PJ, Rouaud O, Ricolfi F, Vighetto A, Pasquier F, Galluzzi S, Delmaire C, Ceccaldi M, Girard N, Lehericy S, Duveau F, Chupin M, Sarazin M, Dormont D, Hampel H; Hippocampus Study Group. Reduced Regional Cortical Thickness Rate of Change in Donepezil-Treated Subjects With Suspected Prodromal Alzheimer's Disease. J Clin Psychiatry. 2016 Dec;77(12):e1631-e1638. doi: 10.4088/JCP.15m10413.

family: Cavedo

full_name: Enrica Cavedo

given: Enrica

family: Dubois

full_name: Bruno Dubois

given: Bruno

family: Colliot

full_name: Olivier Colliot

given: Olivier

family: Lista

full_name: Simone Lista

given: Simone

family: Croisile

full_name: Bernard Croisile

given: Bernard

family: Tisserand

full_name: Guy Louis Tisserand

given: Guy Louis

family: Touchon

full_name: Jacques Touchon

given: Jacques

family: Bonafe

full_name: Alain Bonafe

given: Alain

family: Ousset

full_name: Pierre J. Ousset

given: Pierre J.

family: Rouaud

full_name: Olivier Rouaud

family: Ricolfi

full_name: Fréderic Ricolfi

given: Fréderic

family: Vighetto

full_name: Alain Vighetto

family: Pasquier

full_name: Florence Pasquier

given: Florence

family: Galluzzi

full_name: Samantha Galluzzi

given: Samantha

family: Delmaire

full_name: Christine Delmaire

given: Christine

family: Ceccaldi

full_name: Mathieu Ceccaldi

given: Mathieu

family: Girard

full_name: Nadine Girard

given: Nadine

family: Lehericy

full_name: Stéphane Lehericy

given: Stéphane

family: Duveau

full_name: Françoise Duveau

given: Françoise

family: Chupin

full_name: Marie Chupin

given: Marie

family: Sarazin

full_name: Marie Sarazin

family: Dormont

full_name: Didier Dormont

given: Didier

family: Hampel

full_name: Harald Hampel

given: Harald

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

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

title: Reduced Regional Cortical Thickness Rate of Change in Donepezil-Treated Subjects With Suspected Prodromal Alzheimer’s Disease

ReferenceCitation: Teipel SJ, Cavedo E, Grothe MJ, Lista S, Galluzzi S, Colliot O, Chupin M, Bakardjian H, Dormont D, Dubois B, Hampel H; Hippocampus Study Group. Predictors of cognitive decline and treatment response in a clinical trial on suspected prodromal Alzheimer's disease. Neuropharmacology. 2016 Sep;108:128-35. doi: 10.1016/j.neuropharm.2016.02.005. Epub 2016 Feb 10.


title: Autosomal Dominant Retinitis Pigmentosa: Prevalence of Known Genes Identification of New Loci / Genes

summary: Identify new genes responsible for autosomal dominant retinitis pigmentosa (ADRP), one of the most common causes of hereditary diseases of the retina, and thus better understand the mechanisms involved of the disease."

ReferenceCitation: Audo I, Manes G, Mohand-Saïd S, Friedrich A, Lancelot ME, Antonio A, Moskova-Doumanova V, Poch O, Zanlonghi X, Hamel CP, Sahel JA, Bhattacharya SS, Zeitz C. Spectrum of rhodopsin mutations in French autosomal dominant rod-cone dystrophy patients. Invest Ophthalmol Vis Sci. 2010 Jul;51(7):3687-700. doi: 10.1167/iovs.09-4766. Epub 2010 Feb 17.

name: From INSERM, U968, Paris, France; 2CNRS, UMR_7210, Paris, France; 3UPMC Univ Paris 06, UMR_S 968, Institut de la Vision, Paris, France; 4Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts, INSERM-DHOS CIC 503, Paris, France; 5Department of Mole

family: Audo

full_name: Isabelle Audo

given: Isabelle

family: Manes

full_name: Gaël Manes

given: Gaël

family: Mohand-Saïd

full_name: Saddek Mohand-Saïd

given: Saddek

name: Institut de Génétique et de Biologie Moléculaire et Cellulaire, Illkirch, France;

family: Friedrich

full_name: Anne Friedrich

given: Anne

family: Lancelot

full_name: Marie-Elise Lancelot

given: Marie-Elise

family: Antonio

full_name: Aline Antonio

given: Aline

family: Moskova-Doumanova

full_name: Veselina Moskova-Doumanova

given: Veselina

family: Poch

full_name: Oliver Poch

given: Oliver

name: Service Exploration Fonctionnelle de la Vision et Centre basse vision de la Clinique Sourdille, Nantes, France;

family: Zanlonghi

full_name: Xavier Zanlonghi

given: Xavier

name: U583, INSERM, Institute for Neurosciences de Montpellier, Montpellier, France; 9Centre Hospitalier Régional et Universitaire, Centre de Référence Maladies Sensorielles Génétiques, Montpellier, France; and

family: Hamel

full_name: Christian P. Hamel

given: Christian P.

family: Sahel

full_name: José-Alain Sahel

given: José-Alain

name: From INSERM, U968, Paris, France; 2CNRS, UMR_7210, Paris, France; 3UPMC Univ Paris 06, UMR_S 968, Institut de la Vision, Paris, France; 5Department of Molecular Genetics, Institute of Ophthalmology, London, UK;

family: Bhattacharya

full_name: Shomi S. Bhattacharya

given: Shomi S.

family: Zeitz

full_name: Christina Zeitz

given: Christina

journal_name: Investigative Opthalmology & Visual Science

version: acceptedVersion

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

repository_normalized: HAL

version: submittedVersion

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

repositories:
HAL
PubMed Central

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

publisher: Association for Research in Vision and Ophthalmology (ARVO)

title: Spectrum of Rhodopsin Mutations in French Autosomal Dominant Rod–Cone Dystrophy Patients

lead_sponsor: University Hospital, Montpellier

intervention_type: Genetic


title: Real World Effectiveness of Natalizumab Extended Interval Dosing in Relapsing-Remitting Multiple Sclerosis in a French Cohort

acronym: RELEVANT

summary:
Natalizumab (NTZ) use in Multiple Sclerosis (MS) in highly active patients has been largely established during the last Rationale 10 years in both clinical trials and real-world practice. Along with its efficacy, NTZ use has been limited by potential risk of progressive multifocal leukoencephalopathy (PML). Thus, several studies have tried to assess how to minimize this risk.

One suggested approach is to move from the standard interval dose (SID) of 4 weeks to an extended interval dose (EID) of 5 weeks or longer. Extending the dosing interval of NTZ has been practiced by some physicians with the intention of improving the benefit/risk of the treatment by reducing the exposure-dependent risk of progressive multifocal leukoencephalopathy (PML) while maintaining efficacy. We propose to retrospectively analyze data from clinical records coming from RRMS patients treated in France at 5 different centers; Caen, Nice, Bobigny and Toulouse hospitals as well as Percy Military Hospital, to evaluate the effectiveness of natalizumab EID in subjects who have previously been treated with natalizumab SID for 12 months, in relation to continued SID treatment. In the clinical practice of these centers, patients are shifted after minimum 12 months under SID to an EID of 6 weeks regardless antibody JC serum status. Clinical, magnetic resonance imaging (MRI) and serum anti-JCV antibody status data are collected when available.

The objective of this study is to assess the efficacy in term of ARR and safety.

time_perspective: Retrospective

lead_sponsor: University Hospital, Caen

location_facility: Department of Neurology, Percy Military Hospital

location_facility: Department of Neurology, CHU Bobigny-Avicenne

location_facility: Department of Neurology, CHU Toulouse Purpan


title: "EVALUATION CLINIQUE D'UNE CAPSULE A GUIDAGE MAGNETIQUE POUR L'EXPLORATION GASTRIQUE "Capsule Dirigée Versus Gastroscopie à Haute Définition""

summary: A capsule steered by magnetic field force developed by Siemens and Olympus has recently been evaluated in a pilot series in man with encouraging results (Rey JF, Ogata H, Hosoe N, Ohtsuka K, Ogata N, Ikeda K, Aihara H, Pangtay I, Hibi T, Kudo S, Tajiri H. Feasibility of stomach exploration with a guided capsule endoscope. Endoscopy. 2010;42:541-5. Epub 2010 Jun 30.18). This blinded prospective study investigates the accuracy of the magnetically guided capsule (MGCE) compared to gastroscopy in patients with focal lesions and / or gastric symptoms and indication for upper GI Endoscopy.

ReferenceCitation: Rey JF, Ogata H, Hosoe N, Ohtsuka K, Ogata N, Ikeda K, Aihara H, Pangtay I, Hibi T, Kudo SE, Tajiri H. Blinded nonrandomized comparative study of gastric examination with a magnetically guided capsule endoscope and standard videoendoscope. Gastrointest Endosc. 2012 Feb;75(2):373-81. doi: 10.1016/j.gie.2011.09.030. Epub 2011 Dec 9.

ReferenceCitation: Rey JF, Ogata H, Hosoe N, Ohtsuka K, Ogata N, Ikeda K, Aihara H, Pangtay I, Hibi T, Kudo S, Tajiri H. Feasibility of stomach exploration with a guided capsule endoscope. Endoscopy. 2010 Jul;42(7):541-5. doi: 10.1055/s-0030-1255521. Epub 2010 Jun 30.

ReferenceCitation: Denzer UW, Rösch T, Hoytat B, Abdel-Hamid M, Hebuterne X, Vanbiervielt G, Filippi J, Ogata H, Hosoe N, Ohtsuka K, Ogata N, Ikeda K, Aihara H, Kudo SE, Tajiri H, Treszl A, Wegscheider K, Greff M, Rey JF. Magnetically guided capsule versus conventional gastroscopy for upper abdominal complaints: a prospective blinded study. J Clin Gastroenterol. 2015 Feb;49(2):101-7. doi: 10.1097/MCG.0000000000000110.

family: Denzer

full_name: Ulrike W. Denzer

given: Ulrike W.

family: Rösch

full_name: Thomas Rösch

given: Thomas

family: Hoytat

full_name: Bilal Hoytat

given: Bilal

family: Abdel-Hamid

full_name: Mohammed Abdel-Hamid

given: Mohammed

family: Hebuterne

full_name: Xavier Hebuterne

family: Vanbiervielt

full_name: Geoffroy Vanbiervielt

given: Geoffroy

family: Filippi

full_name: Jérôme Filippi

given: Jérôme

family: Ogata

full_name: Haruiko Ogata

given: Haruiko

family: Hosoe

full_name: Naoki Hosoe

given: Naoki

family: Ohtsuka

full_name: Kazuo Ohtsuka

given: Kazuo

full_name: Noriyuki Ogata

given: Noriyuki

family: Ikeda

full_name: Keiichi Ikeda

given: Keiichi

family: Aihara

full_name: Hiroyuki Aihara

given: Hiroyuki

family: Kudo

full_name: Shin-Ei Kudo

given: Shin-Ei

family: Tajiri

full_name: Hisao Tajiri

given: Hisao

family: Treszl

full_name: Andras Treszl

given: Andras

family: Wegscheider

full_name: Karl Wegscheider

given: Karl

family: Greff

full_name: Michel Greff

given: Michel

family: Rey

full_name: Jean-Francois Rey

given: Jean-Francois

journal_name: Journal of Clinical Gastroenterology

title: Magnetically Guided Capsule Versus Conventional Gastroscopy for Upper Abdominal Complaints

lead_sponsor: Universitätsklinikum Hamburg-Eppendorf

location_facility: Institut Arnault Tzanck , Avenue du Docteur Maurice Donat


title: Etude Comparative Multicentrique Prospective évaluant la Prise en Charge Chirurgicale associée à Une cautérisation Chimique Par Acide TCA Par Rapport à la Prise en Charge Chirurgicale Standard Dans le Traitement de l'Ongle incarné

summary:
Ingrown toenail is a very common disease in the general population that touches young adults. There are lots of treatments from local care of pedicure to surgery with matricectomy. Gold standard of symptomatic and painful ingrown toenail is the simple surgery with matricectomy and with suture or directed healing pad.

For many years chemical cauterisation with phenolic acid is used, a method with very few relapses and with a more simple pad. However, because of a lack of information about this phenolic acid, the pharmaceutical laboratory withdrew it from the market.

The new method to replace phenolic acid is trichloroacetic acid, used mainly in cosmetics for peeling. This method was already compared to phenolic acid and showed equal results with fewer laps of application and a low cost. The comparison between acid trichloroacetic method and the gold standard surgery was never done and will be the goal of this study.

It's an open, non randomised, comparative, multicentric (2 centers) study with two groups : common surgery and surgery with chemical cauterisation For this study the investigators will compare between the two groups : gain of quality of life at one month after surgery, difference of pain between before, one week and one month after surgery, the occurrence of adverse events and number of relapses at one year.

location_facility: Centre hospitalier universitaire de CAEN

location_facility: Centre hospitalier Mémorial France Etats Unis


title: A 3-month, Prospective, Multicentre, Investigator-masked, Parallel-group, Active-controlled, Randomised, Non-inferiority Study to Compare the Efficacy & Tolerability of CATIONORM PRO® & VISMED® in Patients With Mod-to-severe Dry Eye Disease

acronym: PROSIKA

summary:
This study is a prospective, multicentre, parallel-group, active-controlled, non-inferiority study conducted in adult patients with moderate-to-severe dry eye disease (DED) related to keratitis or keratoconjunctivitis. This study is to be conducted in France, Poland and Spain.

The patients will be randomised to receive Cationorm Pro® or the reference treatment, VISMED® (ratio 1:1) in an investigator-masked fashion

lead_sponsor: Santen SAS

location_country: Spain France Poland

location_facility: Klinika Okulistyki i Onkologii Okulistycznej

location_facility: El Instituto Ofalmológico Quirónsalud Zaragoza

location_facility: 5th MILITARY CLINICAL HOSPITAL IN KRAKOW


title: Short 3-week Antibiotic Treatment Versus 6 Weeks in Adults With Septic Arthritis of Native Joint: a Randomized, Open Label, Non-inferiority Trial

acronym: SHASAR

summary: In France, the incidence of native joint infections is about 10 per 100 000 person-years, most commonly caused by S.aureus followed by b-haemolytic streptococci. French and international antibiotic guidelines, based on expert advice and retrospective studies, recommend intravenous antibiotics for two weeks, then oral for 4 weeks without evident link between intravenous, prolonged oral treatment and cure. Long term exposure to antibiotics increases bacterial resistance, a major problem of public health. Several studies show that serious infectious can be treated safely by a shorter treatment and with oral antibiotics. There is no randomized controlled trial to establish the duration of antibiotics in native joint infections. Moreover, no consensus prevails on the administration route and duration of antimicrobial therapy. Although most clinicians acknowledge the interest of oral antibiotics and shorter treatment duration, randomized controlled trials are necessary to evaluate this practice. The SHASAR project aims to evaluate whether a shorter antibiotic treatment (3 week treatment) is safe and not inferior to the conventional 6 week treatment in native joint infections. If successful, this would represent a major advance in terms of patients' quality of life; decreased rate of health-care-related infections and complications, bacterial resistance and cost.

location_facility: Hôpital Saint Antoine - Service de Rhumatologie

location_facility: Hôpital Avicenne - Service de Rhumatologie

location_facility: Hopital Bicêtre, Service de Maladies Infectieuses et Tropicales

location_facility: Hôpital Ambroise Paré - Service de Rhumatologie

location_facility: CHG Pontoise - Centre Hospitalier René Dubos - Service de Rhumatologie

location_facility: Hôpital Pitié Salpetrière - Service de Rhumatologie

location_facility: Hôpital Necker - Service de Maladies Infectieuses

location_facility: Hôpital Henri Mondor - Service de Rhumatologie

location_facility: Hôpital Raymond Poincaré - Service de Maladies Infectieuses

location_facility: Hôpital Tenon - Service de Maladies Infectieuses

location_facility: Hôpital Bichat - Service de Rhumatologie

location_facility: Hôpital Bichat - Service de Maladies Infectieuses

location_facility: Hôpital Lariboisière Service de Rhumatologie

location_facility: Hôpital Cochin - Service de Rhumatologie

location_facility: Hôpital Avicenne - Service de Maladies Infectieuses

location_facility: Hôpital Henri Mondor - Service de Maladies Infectieuses

location_facility: Hôpital Pitié Salpetrière - Service de Maladies Infectieuses

location_facility: Hôpital Cochin - Service de Maladies Infectieuses

location_facility: Hôpital Antoine Béclère - Service de Maladies Infectieuses


title: A Randomized Study of Fludarabine in Part of Induction and Postremission Treatment for de Novo Acute Myeloid Leukaemia in Elderly Patients

summary: In this study, patients were randomly assigned to either receive fludarabine or not (20 mg/m2/d) in addition to induction chemotherapy, consolidation chemotherapy and the 3 subsequent re-induction courses during maintenance.

lead_sponsor: French Innovative Leukemia Organisation


title: Post-stenting Assessment of Reendothelialization With OFDI After CTO Procedure

acronym: PERFECTO

summary: The objective of PERFECTO is to assess the reendothelialization at 3 months after successfully CTO percutaneous intervention (PCI) with new generation drug eluting stent (DES) by OFDI analysis. Designed as a multicentric, observational and prospective study which will be conducted at University Hospital of Poitiers (France), a systematic OFDI analysis will be realized immediately after CTO-PCI and at 3 months. Known as major predictive factors of stent thrombosis, percentages of malapposition, uncovered struts and neointimal hyperplasia proliferation will be measured over the entire length of each stent implanted combining in a composite primary endpoint.

lead_sponsor: Poitiers University Hospital

location_facility:
CHU Poitiers
CHU de Clermont-Ferrand
Institut A.Tzanck
Bressollette
CHU de Nimes
GHM de Grenoble
CHU de Toulouse


summary:
Increasing cesarean rate in France is worrying. Different methods are described for ripening labor : the use of prostaglandins is described but maybe dangerous for patients with scarred uterus and is not recommended.

Intracervical balloon is an efficient alternative methods which as already been tested for unfavorable cervix ripening on nulliparous women.

But it was rarely tested on women with scared uterus and unfavorable cervix (bishop score <4).

The investigators propose a prospective randomised trial comparing cervix ripening with intracervical balloon inflated by 50 ml sterile water during 12 hours versus ocytocin (reference method).

The investigators expect to demonstrate what it's a safe method to increase vaginal delivery for women with previous cesarean section who need an induction of labour.

location_facility: Service Gynécologie Obstétrique et médecine de la reproduction


title: High Flow Nasal Cannula Versus Standard Oxygen Therapy in Children With Status Asthmaticus: a Randomized Controlled Trial

acronym: CANULASTHM

summary: In France, over 2.5 million people suffer from asthma, including one-third of children. This is the chronic respiratory disease leading to the highest rate of hospitalization. The conventional oxygen delivery means in children are the non-rebreather face mask or low flow nasal cannula (standard oxygen therapy - SOT). New non-invasive ventilatory support systems such as High Flow Nasal Cannula (HFNC) are emerging. These are nasal cannulas allowing the delivery of a high air (or oxygen) flow, exceeding the inspiratory flow of patients with acute respiratory failure, allowing to deliver a slight positive expiratory pressure while ensuring humidification and warming of the airways. Aerosol administration is also possible with excellent efficiency and without interrupting respiratory assistance. Physiological data and clinical studies in other pathologies suggest the interest of this technique during the asthma attack, but no comparative study currently exists in this indication. The HFNCs could have their place upstream of Non Invasive Ventilation (NIV), thus replacing non-rebreather face mask sometimes not tolerated by the children. The investigators's hypothesis is that HFNCs could improve patients' health faster, reduce the use of other ventilatory assistance (NIV, invasive ventilation) and reduce the duration of hospitalization in intensive care units or continuous monitoring units (CMU).

location_facility:
CH Annecy Genevois
CHU Strasbourg,
CHU de Dijon
CHU Arnaud de Villeneuve
CHU de Nantes
Chu Lenval
CH Villefranche sur Saône,
Hôpital Necker Enfants Malades
Hôpital Femme-Mère-Enfant
Hôpital Armand Trousseau
Hôpital Robert Debré
CHU de Grenoble Alpes
Hôpital Bicêtre
Hôpital Timone 2


title: Evaluation of Length of Stay and Predisposing Factors of Late Discharge After Transfemoral Transcatheter Aortic Valve Implantation Using the SAPIEN-3 Prosthesis: A French Multicenter Prospective Observational Trial

acronym: FAST-TAVI

summary:
Transcatheter aortic valve implantation (TAVI) has been rapidly adopted worldwide since the first-in-man TAVI performed in 2002. With increasing experience and improvements in valve design, the "minimalist" approach to transfemoral TAVI (using local anesthesia and fluoroscopic guidance) has become an attractive concept, and the technical feasibility of this approach has been well documented.

While earlier data showed prolonged length of stay after TF-TAVI [10.5 ± 8.1 days in the FRANCE 2 registry and 10.2 ± 11.1 days in the PARTNER Cohort A data, the UK TAVI registry (reference) showed a decline in post-TAVI length of stay from 10 days to 8 days over the time period of 2007 to 2012. More contemporary data from other centers has been published showing that 23% of TF-TAVI patients were discharged within 3 days after TAVI. With an increasingly minimalist approach to TF-TAVI, the duration of monitoring required post-procedure remains indeterminate with a lack of formal consensus.

Early discharge (within 3 days of TAVI) is hypothesized to have multiple potential advantages, including reduction in unnecessarily lengthy hospitalization of frail and elderly patients in addition to cost-saving benefits. Rouen University Hospital has previously published a retrospective study on the feasibility and safety of early discharge, in which discharge within 72 hours of uncomplicated TF-TAVI was safe and attained in 36% of our patients. Pre-existing pacemaker and the absence of acute kidney injury were independent predictors of a successful early discharge. Moreover, in a prospective study, Rouen University Hospital recently shown that early discharge afterelective TF-TAVI with SAPIEN-XT/SAPIEN-3 prostheses was attainable in a large proportion of patients (59%) with no evident compromise in safety. Factors associated with failure of early discharge were postprocedural blood transfusion and permanent pacemaker implantation. But currently, there are no guidelines for the length of stay after a TF-TAVI.

lead_sponsor: University Hospital, Rouen

location_facility:
Brest University Hospital
Rennes University Hospital
AP-HP Bichat - Claude Bernard Hospital
Rouen University Hospital
Jacques Cartier Private Hospital


title: Post Traumatic Early Use of High Flow Oxygenation Versus Standard Oxygen for Management of Moderately Hypoxemic Thoracic Trauma: TrOMaTho Study

acronym: TrOMaTho

summary: In France, the average incidence of thoracic trauma is 10,000 to 15,000 each year. These patients are at risk of early and late post traumatic respiratory complications as follows: pneumonia, Acute Respiratory Distress Syndrome (ARDS), hypoxemia. Main issues of thoracic trauma management were recently published by French anesthesiologist and intensivist experts. Non-invasive ventilation (NIV) was recommended in case of severe hypoxemia (PaO2/FiO2 < 200). In comparison to conventional oxygenation or mechanical ventilation, NIV reduced length of stay, incidence of complications and mortality in case of severe hypoxemia. For mild or moderate hypoxemic patients, no devices were tested to prevent respiratory complications. At the moment, low-flow oxygenation is administered to these patients in the absence of severe hypoxemia. Recently, many studies have found promising results with high-flow oxygenation delivered by nasal cannula. This device has many physiological advantages: wash out the naso-pharyngeal dead space, increase end expiratory lung volume, deliver a moderate or low level of Positive end-expiratory pressure (PEEP), improve work of breathing and confort. Several randomized controlled trials tested this device in many clinical settings, but there are no studies on its use after thoracic trauma. A comparative trial is needed to evaluate early prophylactic administration of high-flow oxygenation after thoracic trauma.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility: Kremlin Bicêtre university hospital (APHP)


title: Evaluation of the Use of the Atalante Exoskeleton in Patients Presenting an Hemiplegia Due to Cerebrovascular Accident

acronym: INSPIRE

summary:
The INSPIRE study is interventional, European, prospective, open, multicentric, each patient being his/her own control.

It is conducted to assess the safety and performance of the Atalante exoskeleton system in patients presenting an hemiplegia due to cerebrovascular accident. The primary endpoint is defined by the reported adverse events.

The study will include 40 patients and takes place in six rehabilitation centers (4 in France, 1 in Luxembourg, 1 in Belgium).

lead_sponsor: Wandercraft

location_country: Luxembourg Belgium France

location_facility: Hôpital La Musse, La Renaissance Sanitaire

location_facility: Centre de Médecine Physique et de Réadaptation

location_facility: Centre mutualiste de Rééducation et de Réadaptation de Kerpape


title: Randomized Trial to Assess the Efficacy of a High-intensity Physical Activity Program on Renal Function Decline in High Risk Patients With Type 2 Diabetes

acronym: ACTIDIANE

summary:
Type 2 diabetes is a chronic condition whose prevalence is increasing globally. Kidney disease is a key complication of diabetes and is among the most common cause of end-stage renal disease, requiring renal replacement therapy.

It has been shown that the trajectory of renal function (estimated glomerular filtration rate - eGFR) is of great prognostic value for renal and cardiovascular endpoints in diabetic patients. However the clinical use of this prognostic marker is not associated to date with a clear therapeutic intervention, effective in patients with type 2 diabetes identified with this biomarker.

In France, type 2 diabetes patients have twice less physical activity than non-diabetic persons. Recently, it has been published that physical activity was associated with an improvement of renal risk in patients with type 2 diabetes, recruited from the LOOK-AHEAD study. It was demonstrated that high-intensity physical activity (HIPA) can have several additional advantages over moderate-intensity, on blood pressure improvement, and cardiovascular risk profile modification. In addition, this procedure was shown to be safe in patients with high cardiovascular risk.

We plan to perform a randomized intervention comparing a structured program of high-intensity physical activity (HIPA) vs standard recommendations for physical activity on renal function decline (primary outcome) and mortality, renal and cardiovascular endpoints, patients' safety and quality of life (secondary outcomes). Study participants will be patients with established type 2 diabetes and a high renal risk, identified by rapid renal function decline, defined as a eGFR slope below -5ml/min per 1.73 m2/yr. The intervention is planned to last for 2 years.

ipd_sharing_description: sharing policy is under the responsibility of the scientific committee who will organise this point Any request can be posted to the PI in the meantime.

location_country: Belgium France

location_facility:
CHU Strasbourg
CHU Toulouse
Poitiers University Hospital
Chu de Lyon
Besançon Hospital
Bichat University Hospital
CHG Sud Francilien
CHU de TOURS
CHRU
Hospital of Liège
Hôpital Pitié Salpétrière
CHU Dijon
Caen University Hospital
CHU Nancy
CH Chartres
La Riboisière Hospital
CHU Lille
Bordeaux University Hospital
Chu de Nice
Clermont Ferrand University Hospital


title: National Registry of rFVIIa (Novoseven) in Haemorrhagic Traumatology

summary:
The rFVIIa (Novoseven) has been tested in traumatic hemorrhage but its efficiency has not been proven yet in this context. A national register has been set up in France identifying the patients which received rFVIIa.

Those patients had persistent and active bleeding after severe trauma despite surgery and/or interventional radiology embolization.

The aim of this present study is to report the first clinical results in those situations of patients treated with rFVIIa.

ReferenceCitation: Boffard KD, Riou B, Warren B, Choong PI, Rizoli S, Rossaint R, Axelsen M, Kluger Y; NovoSeven Trauma Study Group. Recombinant factor VIIa as adjunctive therapy for bleeding control in severely injured trauma patients: two parallel randomized, placebo-controlled, double-blind clinical trials. J Trauma. 2005 Jul;59(1):8-15; discussion 15-8.

ReferenceCitation: Martinowitz U, Kenet G, Segal E, Luboshitz J, Lubetsky A, Ingerslev J, Lynn M. Recombinant activated factor VII for adjunctive hemorrhage control in trauma. J Trauma. 2001 Sep;51(3):431-8; discussion 438-9.

ReferenceCitation: Rizoli SB, Boffard KD, Riou B, Warren B, Iau P, Kluger Y, Rossaint R, Tillinger M; NovoSeven Trauma Study Group. Recombinant activated factor VII as an adjunctive therapy for bleeding control in severe trauma patients with coagulopathy: subgroup analysis from two randomized trials. Crit Care. 2006;10(6):R178.

ReferenceCitation: Harrison TD, Laskosky J, Jazaeri O, Pasquale MD, Cipolle M. "Low-dose" recombinant activated factor VII results in less blood and blood product use in traumatic hemorrhage. J Trauma. 2005 Jul;59(1):150-4.

ReferenceCitation: Delannoy B, Levrat A, Chamouard V, Aulagner G, Perdrix JP, Négrier C, Allaouchiche B. [Off label use of recombinant activated factor VII: a practice survey]. Ann Fr Anesth Reanim. 2007 Sep;26(9):774-9. Epub 2007 Jul 16. French.

lead_sponsor: University Hospital, Grenoble

location_facility:
MIQUET
NADJI
DAVID
DEBIEN
LEPOUSE
ICHAI
MEROUANI
SEDILLOT
JAULT
COOK
DECLETY
MOREL
MEAUDRE
PEASE
LEBAS
GARRIGUE
FREYS
BULEON
GUITARD
CHARBIT
FAVIER
OLIVIER
Nanadoumgar
LEFRANT
YUNG
Duranteau
Mateo A Loris
LAIGLE
Bleichner
GUELON
GARCIN
SANTRE
AUDIBERT
JOURNOIS
MARTIN
LANGERON
FLOCARD
Vinsiniti
CHUPIN


title: Randomized Controlled Trial Evaluating the Efficacy of an Adapted Physical Activity Program Using a Connected Device With Activity Trackers and a Therapeutic Education Program Among Women With Localized Breast Cancer

acronym: DISCO

summary: The 3-year DISCO study aims to systematically implement physical activity in breast cancer patients. The primary objective is to investigate the efficacy of a connected device (personalized non-supervised exercise program including a wristband as activity tracker, a smartphone application, and a website) and the efficacy of a therapeutic education program on the physical activity level of patients at the end of the 6-month programs. The research hypothesis is that patients participating in the intervention with the connected device or in the therapeutic education program will achieve the international recommendations in terms of physical activity, compared to women receiving only physical activity recommendations.

primary_purpose: Supportive Care

ReferenceCitation: Beasley JM, Kwan ML, Chen WY, Weltzien EK, Kroenke CH, Lu W, Nechuta SJ, Cadmus-Bertram L, Patterson RE, Sternfeld B, Shu XO, Pierce JP, Caan BJ. Meeting the physical activity guidelines and survival after breast cancer: findings from the after breast cancer pooling project. Breast Cancer Res Treat. 2012 Jan;131(2):637-43. doi: 10.1007/s10549-011-1770-1. Epub 2011 Sep 21.

ReferenceCitation: Beg MS, Gupta A, Stewart T, Rethorst CD. Promise of Wearable Physical Activity Monitors in Oncology Practice. J Oncol Pract. 2017 Feb;13(2):82-89. doi: 10.1200/JOP.2016.016857. Review.

ReferenceCitation: Cadmus-Bertram LA, Marcus BH, Patterson RE, Parker BA, Morey BL. Randomized Trial of a Fitbit-Based Physical Activity Intervention for Women. Am J Prev Med. 2015 Sep;49(3):414-8. doi: 10.1016/j.amepre.2015.01.020. Epub 2015 Jun 10.

ReferenceCitation: Ferguson T, Rowlands AV, Olds T, Maher C. The validity of consumer-level, activity monitors in healthy adults worn in free-living conditions: a cross-sectional study. Int J Behav Nutr Phys Act. 2015 Mar 27;12:42. doi: 10.1186/s12966-015-0201-9.

ReferenceCitation: Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.

ReferenceCitation: Ibrahim EM, Al-Homaidh A. Physical activity and survival after breast cancer diagnosis: meta-analysis of published studies. Med Oncol. 2011 Sep;28(3):753-65. doi: 10.1007/s12032-010-9536-x. Epub 2010 Apr 22.

ReferenceCitation: Lahart IM, Metsios GS, Nevill AM, Carmichael AR. Physical activity, risk of death and recurrence in breast cancer survivors: A systematic review and meta-analysis of epidemiological studies. Acta Oncol. 2015 May;54(5):635-54. doi: 10.3109/0284186X.2014.998275. Epub 2015 Mar 9. Review.

ReferenceCitation: Sullivan AN, Lachman ME. Behavior Change with Fitness Technology in Sedentary Adults: A Review of the Evidence for Increasing Physical Activity. Front Public Health. 2017 Jan 11;4:289. doi: 10.3389/fpubh.2016.00289. eCollection 2016. Review.

ReferenceCitation: Thariat J, Creisson A, Chamignon B, Dejode M, Gastineau M, Hébert C, Boissin F, Topfer C, Gilbert E, Grondin B, Guennoc H, Mari V, Buzzo S, Saja D, Duboue N, Boulahssass R, Tosi A, Verne S, Ducray J, Benard-Thiery I, Ferrero JM. [Integrating patient education in your oncology practice]. Bull Cancer. 2016 Jul-Aug;103(7-8):674-90. doi: 10.1016/j.bulcan.2016.04.007. Epub 2016 Jun 7. Review. French.

ReferenceCitation: Tudor-Locke C, Hatano Y, Pangrazi RP, Kang M. Revisiting "how many steps are enough?". Med Sci Sports Exerc. 2008 Jul;40(7 Suppl):S537-43. doi: 10.1249/MSS.0b013e31817c7133.

ReferenceCitation: Touillaud M, Fournier B, Pérol O, Delrieu L, Maire A, Belladame E, Pérol D, Perrier L, Preau M, Leroy T, Fassier JB, Fillol F, Pascal S, Durand T, Fervers B. Connected device and therapeutic patient education to promote physical activity among women with localised breast cancer (DISCO trial): protocol for a multicentre 2×2 factorial randomised controlled trial. BMJ Open. 2021 Sep 13;11(9):e045448. doi: 10.1136/bmjopen-2020-045448.

lead_sponsor: Centre Leon Berard

location_facility:
Centre Léon Bérard
CHRU Besançon
Institut Sainte-Catherine


title: Comparison of Accidents and Their Circumstances With Oral Anticoagulants. The CACAO Study

acronym: CACAO

summary:
Differences in efficacy and safety between new oral anticoagulants (NOAC) and vitamin K antagonist (VKA) in real practice remain uncertain.

The few existing ambulatory studies did not answer all NOAC specific issues, such as prescription habits and motives, patients characteristics, biological monitoring, as well as the occurrence of major and minor thromboembolic events, especially in France where warfarin is less frequently prescribed.

Therefore, in order to describe clinical and follow up characteristics of patients receiving oral anticoagulants, the investigators will set up a national prospective cohort to compare the occurrence of thromboembolic events between VKA and NOAC in primary care.

ReferenceCitation: Kearon C. Natural history of venous thromboembolism. Circulation. 2003 Jun 17;107(23 Suppl 1):I22-30. Review.

ReferenceCitation: You JJ, Singer DE, Howard PA, Lane DA, Eckman MH, Fang MC, Hylek EM, Schulman S, Go AS, Hughes M, Spencer FA, Manning WJ, Halperin JL, Lip GYH. Antithrombotic therapy for atrial fibrillation: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e531S-e575S. doi: 10.1378/chest.11-2304.

ReferenceCitation: Mantilla CB, Horlocker TT, Schroeder DR, Berry DJ, Brown DL. Frequency of myocardial infarction, pulmonary embolism, deep venous thrombosis, and death following primary hip or knee arthroplasty. Anesthesiology. 2002 May;96(5):1140-6. Erratum in: Anesthesiology 2002 Aug;97(2):531.

ReferenceCitation: Galanaud JP, Sevestre-Pietri MA, Bosson JL, Laroche JP, Righini M, Brisot D, Boge G, van Kien AK, Gattolliat O, Bettarel-Binon C, Gris JC, Genty C, Quere I; OPTIMEV-SFMV Investigators. Comparative study on risk factors and early outcome of symptomatic distal versus proximal deep vein thrombosis: results from the OPTIMEV study. Thromb Haemost. 2009 Sep;102(3):493-500. doi: 10.1160/TH09-01-0053.

ReferenceCitation: Douketis J, Tosetto A, Marcucci M, Baglin T, Cosmi B, Cushman M, Kyrle P, Poli D, Tait RC, Iorio A. Risk of recurrence after venous thromboembolism in men and women: patient level meta-analysis. BMJ. 2011 Feb 24;342:d813. doi: 10.1136/bmj.d813. Review.

ReferenceCitation: Ruff CT, Giugliano RP, Braunwald E, Hoffman EB, Deenadayalu N, Ezekowitz MD, Camm AJ, Weitz JI, Lewis BS, Parkhomenko A, Yamashita T, Antman EM. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet. 2014 Mar 15;383(9921):955-62. doi: 10.1016/S0140-6736(13)62343-0. Epub 2013 Dec 4.

ReferenceCitation: Miller CS, Grandi SM, Shimony A, Filion KB, Eisenberg MJ. Meta-analysis of efficacy and safety of new oral anticoagulants (dabigatran, rivaroxaban, apixaban) versus warfarin in patients with atrial fibrillation. Am J Cardiol. 2012 Aug 1;110(3):453-60. doi: 10.1016/j.amjcard.2012.03.049. Epub 2012 Apr 24. Review.

ReferenceCitation: Adam SS, McDuffie JR, Ortel TL, Williams JW Jr. Comparative effectiveness of warfarin and new oral anticoagulants for the management of atrial fibrillation and venous thromboembolism: a systematic review. Ann Intern Med. 2012 Dec 4;157(11):796-807. Review.

ReferenceCitation: Uchino K, Hernandez AV. Dabigatran association with higher risk of acute coronary events: meta-analysis of noninferiority randomized controlled trials. Arch Intern Med. 2012 Mar 12;172(5):397-402. doi: 10.1001/archinternmed.2011.1666. Epub 2012 Jan 9. Review.

ReferenceCitation: Larsen TB, Rasmussen LH, Skjøth F, Due KM, Callréus T, Rosenzweig M, Lip GY. Efficacy and safety of dabigatran etexilate and warfarin in "real-world" patients with atrial fibrillation: a prospective nationwide cohort study. J Am Coll Cardiol. 2013 Jun 4;61(22):2264-73. doi: 10.1016/j.jacc.2013.03.020. Epub 2013 Apr 3.

ReferenceCitation: Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4.

ReferenceCitation: Frappé P, Cogneau J, Gaboreau Y, Abenhaïm N, Bayen M, Guichard C, Jacquet JP, Lacoin F, Liébart S, Bertoletti L, Bosson JL; CACAO study investigators. Anticoagulants' Safety and Effectiveness in General Practice: A Nationwide Prospective Cohort Study. Ann Fam Med. 2020 Mar;18(2):131-138. doi: 10.1370/afm.2495.

family: Frappé

full_name: Paul Frappé

given: Paul

family: Cogneau

full_name: Joël Cogneau

given: Joël

family: Gaboreau

full_name: Yoann Gaboreau

given: Yoann

family: Abenhaïm

full_name: Nathan Abenhaïm

given: Nathan

family: Bayen

full_name: Marc Bayen

given: Marc

family: Guichard

full_name: Claude Guichard

given: Claude

family: Jacquet

full_name: Jean-Pierre Jacquet

given: Jean-Pierre

family: Lacoin

full_name: François Lacoin

given: François

family: Liébart

full_name: Sandra Liébart

given: Sandra

family: Bertoletti

full_name: Laurent Bertoletti

given: Laurent

family: Bosson

full_name: Jean-Luc Bosson

given: Jean-Luc

journal_name: The Annals of Family Medicine

oa_colors: green other

evidence: open (via free pdf)

repository_institution: University of Geneva - Archive ouverte UNIGE

publisher: Annals of Family Medicine

publisher_dissemination: Annals of Family Medicine

publisher_group: Annals of Family Medicine

publisher_normalized: Annals of Family Medicine

title: Anticoagulants’ Safety and Effectiveness in General Practice: A Nationwide Prospective Cohort Study

ReferenceCitation: Frappé P, Cogneau J, Gaboreau Y, Abenhaïm N, Bayen M, Calafiore M, Guichard C, Jacquet JP, Lacoin F, Bertoletti L; CACAO study investigators. Areas of improvement in anticoagulant safety. Data from the CACAO study, a cohort in general practice. PLoS One. 2017 Apr 6;12(4):e0175167. doi: 10.1371/journal.pone.0175167. eCollection 2017.

location_facility:
Office-based general practitioner
Office-based general practioner
Office-based practitioner


title: "Comparison of Two Methods of Securing Endotracheal Tubes in Intensive Care : Elastic Adhesive Strips vs Lace In A Protective Sheath. A Randomized Multicenter, Cluster and Crossover Controlled Study. FIXATUB"

acronym: FIXATUB

summary:
Every year, in France, nearly 100,000 patients hospitalized in intensive care more than 48 hours require invasive respiratory assistance via an endotracheal tube.

Appropriate tube fixation is essential to ensure effective ventilation while minimizing potential complications such as accidental extubations. However, the fixation system chosen may lead to peribuccal lesions such as bedsores, shearing or cutaneous-mucous tear. These lesions are painful for patients and often unsightly as scar may remain.

There are no formal recommendations for the use of any type of fixing system. Thus, systems used to secure the endotracheal tube vary from one ICU to another.

The objective of this study is to demonstrate that the fixing strategy by elastic adhesive tape reduces the risk of developing a peribuccal lesion during the time of the endotracheal tube's maintenance.

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility:
Hôpital Nord Laennec
Centre Hopitalier La Rochelle
CH Victor Dupouy
CHU La Réunion GHSR
CHI Poissy - Saint-Germain-en-Laye
CHU de Poitiers
CHU Nantes Hôtel Dieu
CHU de Tours
Centre Hospitalier d'Angoulême
Centre Hospitalier Régional d'Orléans
Groupe Hospitalier Bretagne Sud
CH Saint-Nazaire
Centre Hospitalier Le Mans


title: Two-years Follow-up of Melanoma Patients Treated by Nivolumab During the French ATU Program

acronym: Post-ATU

summary:
Nivolumab obtained European Marketing authorization in June 2015. Before this date, a Temporary Authorization for Use (ATU) Program in France for nivolumab was set up between September 2014 and August 2015. This program enrolled approximately 600 melanoma patients (unresectable or metastatic).

It appears relevant to conduct a study on patients treated during the ATU to assess thoroughly patient characteristics, efficacy, safety, and patterns of use of nivolumab in real-life conditions.

lead_sponsor: Nantes University Hospital

location_facility:
AP-HP Hôpital Ambroise Paré
Centre Léon Bérard de Lyon
Hôpitaux de Marseille
CH de PAU
Ch Valence
Chu Dijon
CH du Mans
Chu Amiens
CHU de Rouen
CHU NICE
CHU de Grenoble
Chu Toulouse
Chru Lille
Hospices Civils de Lyon: Lyon Sud
Hopital St andré-CHU DE Bordeaux
Institut Gustave Roussy
Chu Clermont-Ferrand


title: Phase III Study of Monotherapy by Gemcitabine or Vinorelbine Comparing to Doublet by Carboplatin and Paclitaxel Among Elderly Patients With Stage IIIB/IV NSCLC (Obligatory Second-line by Erlotinib)

summary: The last ASCO recommendations in 2003 for the treatment of a CBNPC of stage IIIB/IV of elderly people, are to manage a monochemotherapy. Paclitaxel in association with carboplatin is feasible in elderly patients and the retrospective analysis of two studies of the comparing SWOG, one this association with that of cisplatine and vinorelbine and the other cisplatine only with cisplatine and vinorelbine, showed among 117 the 70 years old patients and more, the absence of significant difference of survival and toxicity compared to the younger patients. The study recently published of Lilenbaum and Al shows that among patients with bad PS, association carboplatine and paclitaxel do better than the paclitaxel only. The paclitaxel managed in weekly form is likely of a better activity by exposing the cancerous cells in a repeated way with shorter intervals without allowing the emergence of resistant clones and by allowing an increase in the intensity of amount. This mode of administration appeared at the same time effective and tolerated very well among patients of more than 70 years. The weekly association of carboplatin and paclitaxel was tested in phase II and showed a rate of response of 14% and one survival 1 year from 31% a randomized test (not dedicated to the old person) of phase II to 3 arms was led by Belani et al.. The best combination of carboplatine + paclitaxel weekly proved to be that associating paclitaxel 100mg/m² 3 weeks out of 4 and carboplatine AUC 6 in J1 with J1 = J29. A test of phase II dedicated the 70 years old to patients and more was carried out in France taking again this association carboplatine (AUC 6) every 4 weeks and paclitaxel weekly (90 mg/m² J1, J8 and J15). This test having included 51 patients highlighted a median of 10,42 months survival (IC 95%: 7,29-17,05)

ReferenceCitation: Pujol JL, Milleron B, Molinier O, Quoix E, Depierre A, Breton JL, Gervais R, Debieuvre D, Hominal S, Namouni F, Tonelli D. Weekly paclitaxel combined with monthly carboplatin in elderly patients with advanced non-small cell lung cancer: a multicenter phase II study. J Thorac Oncol. 2006 May;1(4):328-34.

ReferenceCitation: Quoix E, Zalcman G, Oster JP, Westeel V, Pichon E, Lavolé A, Dauba J, Debieuvre D, Souquet PJ, Bigay-Game L, Dansin E, Poudenx M, Molinier O, Vaylet F, Moro-Sibilot D, Herman D, Bennouna J, Tredaniel J, Ducoloné A, Lebitasy MP, Baudrin L, Laporte S, Milleron B; Intergroupe Francophone de Cancérologie Thoracique. Carboplatin and weekly paclitaxel doublet chemotherapy compared with monotherapy in elderly patients with advanced non-small-cell lung cancer: IFCT-0501 randomised, phase 3 trial. Lancet. 2011 Sep 17;378(9796):1079-88. doi: 10.1016/S0140-6736(11)60780-0. Epub 2011 Aug 8.

family: Quoix

full_name: Elisabeth Quoix

given: Elisabeth

family: Zalcman

full_name: Gérard Zalcman

given: Gérard

family: Oster

full_name: Jean-Philippe Oster

given: Jean-Philippe

family: Westeel

full_name: Virginie Westeel

given: Virginie

family: Pichon

full_name: Eric Pichon

given: Eric

family: Lavolé

full_name: Armelle Lavolé

given: Armelle

family: Dauba

full_name: Jérôme Dauba

given: Jérôme

family: Debieuvre

full_name: Didier Debieuvre

given: Didier

family: Souquet

full_name: Pierre-Jean Souquet

given: Pierre-Jean

family: Bigay-Game

full_name: Laurence Bigay-Game

given: Laurence

family: Dansin

full_name: Eric Dansin

family: Poudenx

full_name: Michel Poudenx

family: Molinier

full_name: Olivier Molinier

given: Olivier

family: Vaylet

full_name: Fabien Vaylet

given: Fabien

family: Moro-Sibilot

full_name: Denis Moro-Sibilot

given: Denis

family: Herman

full_name: Dominique Herman

given: Dominique

family: Bennouna

full_name: Jaafar Bennouna

given: Jaafar

family: Tredaniel

full_name: Jean Tredaniel

given: Jean

family: Ducoloné

full_name: Alain Ducoloné

given: Alain

family: Lebitasy

full_name: Marie-Paule Lebitasy

given: Marie-Paule

family: Baudrin

full_name: Laurence Baudrin

family: Laporte

full_name: Silvy Laporte

given: Silvy

family: Milleron

full_name: Bernard Milleron

given: Bernard

ReferenceCitation: Quoix E, Westeel V, Moreau L, Pichon E, Lavolé A, Dauba J, Debieuvre D, Souquet PJ, Bigay-Game L, Dansin E, Poudenx M, Molinier O, Vaylet F, Moro-Sibilot D, Herman D, Sennelart H, Tredaniel J, Mennecier B, Morin F, Baudrin L, Milleron B, Zalcman G; Intergroupe Francophone de Cancérologie Thoracique. Second-line therapy in elderly patients with advanced nonsmall cell lung cancer. Eur Respir J. 2014 Jan;43(1):240-9. doi: 10.1183/09031936.00048213. Epub 2013 Oct 10.

name: on behalf of Intergroupe Francophone de Cancerologie Thoracique

location_facility:
CHU - Pneumologie
Hôpital Tenon - Pneumologie
CHU Besancon - Pneumologie
CHU
CH - Pneumologie