title: Non-Comparative, Open-Label, Multiple Cohort, Phase 1/2 Study of Nivolumab Monotherapy and Nivolumab Combination Therapy in Subjects With Virus-Positive and Virus-Negative Solid Tumors

summary:
The purpose of this study to investigate the safety and effectiveness of nivolumab, and nivolumab combination therapy, to treat patients who have virus-associated tumors. Certain viruses have been known to play a role in tumor formation and growth. This study will investigate the effects of the study drugs, in patients who have the following types of tumors:

Anal canal cancer-No longer enrolling this tumor type
Cervical cancer
Epstein Barr Virus (EBV) positive gastric cancer-No longer enrolling this tumor type
Merkel Cell Cancer
Penile cancer-No longer enrolling this tumor type
Vaginal and vulvar cancer-No longer enrolling this tumor type
Nasopharyngeal Cancer - No longer enrolling this tumor type
Head and Neck Cancer - No longer enrolling this tumor type

ReferenceCitation: Ferris RL, Spanos WC, Leidner R, Gonçalves A, Martens UM, Kyi C, Sharfman W, Chung CH, Devriese LA, Gauthier H, Chiosea SI, Vujanovic L, Taube JM, Stein JE, Li J, Li B, Chen T, Barrows A, Topalian SL. Neoadjuvant nivolumab for patients with resectable HPV-positive and HPV-negative squamous cell carcinomas of the head and neck in the CheckMate 358 trial. J Immunother Cancer. 2021 Jun;9(6). pii: e002568. doi: 10.1136/jitc-2021-002568. Erratum in: J Immunother Cancer. 2021 Aug;9(8):.

family: Ferris

full_name: Robert L Ferris

given: Robert L

family: Spanos

full_name: William C Spanos

given: William C

family: Leidner

full_name: Rom Leidner

given: Rom

family: Gonçalves

full_name: Anthony Gonçalves

family: Martens

full_name: Uwe M Martens

given: Uwe M

family: Kyi

full_name: Chrisann Kyi

given: Chrisann

family: Sharfman

full_name: William Sharfman

given: William

family: Chung

full_name: Christine H Chung

given: Christine H

family: Devriese

full_name: Lot A Devriese

given: Lot A

family: Gauthier

full_name: Helene Gauthier

given: Helene

family: Chiosea

full_name: Simon I Chiosea

given: Simon I

family: Vujanovic

full_name: Lazar Vujanovic

given: Lazar

family: Taube

full_name: Janis M Taube

given: Janis M

family: Stein

full_name: Julie E Stein

given: Julie E

family: Li

full_name: Jun Li

given: Jun

full_name: Bin Li

given: Bin

family: Chen

full_name: Tian Chen

given: Tian

family: Barrows

full_name: Adam Barrows

given: Adam

family: Topalian

full_name: Suzanne L Topalian

given: Suzanne L

journal_name: Journal for ImmunoTherapy of Cancer

ReferenceCitation: Topalian SL, Bhatia S, Amin A, Kudchadkar RR, Sharfman WH, Lebbé C, Delord JP, Dunn LA, Shinohara MM, Kulikauskas R, Chung CH, Martens UM, Ferris RL, Stein JE, Engle EL, Devriese LA, Lao CD, Gu J, Li B, Chen T, Barrows A, Horvath A, Taube JM, Nghiem P. Neoadjuvant Nivolumab for Patients With Resectable Merkel Cell Carcinoma in the CheckMate 358 Trial. J Clin Oncol. 2020 Aug 1;38(22):2476-2487. doi: 10.1200/JCO.20.00201. Epub 2020 Apr 23.

name: Johns Hopkins Bloomberg∼Kimmel Institute for Cancer Immunotherapy, Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD

name: University of Washington, Seattle Cancer Care Alliance, Seattle, WA

name: Levine Cancer Institute, Atrium Healthcare, Charlotte, NC

name: Winship Cancer Institute of Emory University, Atlanta, GA

name: Université de Paris, INSERM U976, and Dermatology and CIC, AP-HP, Saint Louis Hospital, Paris, France

name: Institut Claudius Regaud, IUCT-Oncopole, Toulouse, France

name: Memorial Sloan Kettering Cancer Center, New York, NY

name: H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL

name: SLK-Clinics, MOLIT Institute, Heilbronn, Germany

name: University of Pittsburgh Medical Center Hillman Cancer Center, Pittsburgh, PA

name: University Medical Center Utrecht, Cancer Center, Utrecht, the Netherlands

name: University of Michigan Comprehensive Cancer Center, Ann Arbor, MI

publisher: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Naumann RW, Hollebecque A, Meyer T, Devlin MJ, Oaknin A, Kerger J, López-Picazo JM, Machiels JP, Delord JP, Evans TRJ, Boni V, Calvo E, Topalian SL, Chen T, Soumaoro I, Li B, Gu J, Zwirtes R, Moore KN. Safety and Efficacy of Nivolumab Monotherapy in Recurrent or Metastatic Cervical, Vaginal, or Vulvar Carcinoma: Results From the Phase I/II CheckMate 358 Trial. J Clin Oncol. 2019 Nov 1;37(31):2825-2834. doi: 10.1200/JCO.19.00739. Epub 2019 Sep 5.

name: Levine Cancer Institute, Atrium Health, Charlotte, NC

name: UCL Cancer Institute, London, United Kingdom

name: Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology, Barcelona, Spain

name: Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium

name: Clínica Universidad de Navarra, Navarra, Spain

name: Institut Roi Albert II, Service d’Oncologie Médicale, Cliniques Universitaires Saint-Luc and Institut de Recherche Clinique et Expérimentale (IREC, Pole MIRO), UCLouvain, Brussels, Belgium

name: University of Glasgow, Glasgow, United Kingdom

name: START Madrid Centro Integral Oncológico Clara Campal, Madrid, Spain

name: Johns Hopkins Bloomberg-Kimmel Institute for Cancer Immunotherapy and Kimmel Cancer Center, Baltimore, MD

name: Stephenson Cancer Center at the University of Oklahoma, Oklahoma City, OK, and Sarah Cannon Research Institute, Nashville, TN

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

repository_institution: Universidad De Navarra - Deposito Academico Digital Universidad De Navarra

repository_institution: University College London - UCL Discovery

repository_institution: Consorci de Serveis Universitaris de Catalunya - RECERCAT

repository_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Appelbaum J, Wells D, Hiatt JB, Steinbach G, Stewart FM, Thomas H, Nghiem P, Kapur RP, Thompson JA, Bhatia S. Fatal enteric plexus neuropathy after one dose of ipilimumab plus nivolumab: a case report. J Immunother Cancer. 2018 Aug 31;6(1):82. doi: 10.1186/s40425-018-0396-9.

location_country:
United States
Mexico
Netherlands
France
Japan
Belgium
Spain
Germany
United Kingdom
Korea, Republic of
Taiwan

location_facility: Memorial Sloan-Kettering Cancer Center-Breast Center

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: Centro de Atencion e Investigacion Clinica en Oncologia SCP

location_facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

location_facility: University Of Michigan Comprehensive Cancer Center

location_facility: COI Centro Oncologico Internacional S.A.P.I. de C.V.


title: Description of an Immune Activation Profile Linked to Insulin Resistance in Subjects Aged 55-69

acronym: METACTIV

summary: The aim of the study is to describe an immune activation profile of people at risk of insulin resistance based on a wide range of markers which will allow easy identification of patients at risk.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Centre d'examen de santé de la Sécurité Sociale de Nîmes

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Evaluation of Biomarkers Combination Performance for the Diagnosis of Neonatal Sepsis in NICU Hospitalized Newborns

acronym: EMERAUDE

summary:
Late-onset neonatal sepsis (LOS), occurring in newborn of at least 7 days of life, is frequently observed in Neonatal Intensive Care Units (NICUs) and potentially severe (mortality, neurologic and respiratory impairments).

Despite its high prevalence, a reliable diagnostic remains difficult. Currently, nonspecific clinical signs that might be linked to other neonatal conditions, such as prematurity and birth defects are used to determine the diagnosis of LOS. Laboratory results of biological markers, such as C-Reactive Protein (CRP) and Procalcitonin (PCT) are often delayed in comparison with LOS onset. Blood culture results are too late and lack sensitivity.

Excessive antibiotic use is observed in a large proportion of NICU hospitalized newborns. This results in an increased antibiotic resistance, microbiota modification, neonatal complications (pulmonary, ophthalmologic and neurologic) and mortality.

The primary objective is to identify, on a cohort of 200 patients, the optimal biomarker combination with good diagnostic performance (i.e. with maximal Area Under the ROC Curve) to early exclude a LOS diagnostic in newborns of at least 7 days of life with suggestive signs.

This identification will be carried out, as a secondary objective, with a sub-group of pre-term neonates whose birth weight is less than 1500 grams. The diagnostic value of the clinical signs that are suggestive of LOS will also be determined (sensitivity, specificity, negative and positive predictive values).

Once identified, the biomarker combination is expected to reduce unjustified antibiotic use.

study_type: Interventional

primary_purpose: Diagnostic

ipd_sharing: No

lead_sponsor: Hospices Civils de Lyon

location_facility:
Hospices Civils de Lyon
CHU de Nantes

intervention_type: Biological


type: Other Identifier

title: Phages Dynamics and Influences During Human Gut Microbiome Establishment

acronym: METAKIDS

summary: Microbial communities are key components of human environment. Consequently, human gut microbiome have been extensively studied providing a better understanding of the relations between bacterial populations and host physiology. However, a typical analysis tends to elude the complexity of the mixes in term of species, strains, as well as extra-chromosomal DNA molecules such as and phages. MetaKids project aims at bringing, at an unprecedented resolution, a new view of those populations and the internal relationships during human gut establishment, a crucial step with long-term impacts on host health. This project relies on the ability of Meta3C, a newly technique developed in the lab, to identify the bacterial host genomes of the different phages the investigators will detect thanks to the physical collision these molecules experience. Given the role that human gut phages may play in shaping the development of host microbiomes, their potential for application is of great interest.

status: Terminated

lead_sponsor: Institut Pasteur

location_facility:
Crèche La Farandole
Crèche du Parc

status_simplified: Unknown


title: Efficacy and Safety of Plitidepsin in Patients With Advanced Unresectable or Metastatic, Relapsed/Refractory, Dedifferentiated Liposarcoma (DLPS): an Exploratory Phase II Multicenter Trial

acronym: APLIPO

summary: Liposarcomas are soft tissue sarcomas most frequent. We distinguish three subtypes on the basis of their histological and cytogenetic characteristics: well-differentiated liposarcoma / dedifferentiated, myxoid liposarcoma and / or round cell liposarcoma and pleomorphic. Dedifferentiated liposarcomas (LDD) represent 20% of liposarcomas and are characterized by well-differentiated component associated with a contingent sarcomatous differentiation and fat-usually high grade. The LDD are most often rétropértionéal seat. Thus, their development is very long asymptomatic. At diagnosis, tumor volume is often very important making surgical removal impossible in a high proportion of cases. Operable tumors have also a risk of local recurrence by about 50% and about 20% metastatic. Chemotherapy is the only treatment of these advanced forms. However, the currently available drugs (adriamycin, ifosfamide) have only very limited effectiveness. Progression-free survival of patients does not exceed 2 months. The LDD is characterized cytogenetically by the constant presence of two amplicons (1p32 and 6q23) respectively targeting genes MAP3K5 and JUN. These two genes encode proteins involved in the signaling pathway Jun N-terminal kinase (JNK). Activation of JNK is involved in the loss of adipose differentiation and tumor aggressiveness of LDD. The plitidepsin is a drug capable of inducing apoptosis of tumor cells carrying a functional activation of the JNK pathway. This drug has such a pro-apoptotic and anti-proliferative in vitro models of LDD. plitidepsin could represent the treatment of choice for patients with advanced LDD. The objective of this study is to evaluate the anti-tumor activity of plitidepsin patients with locally advanced dedifferentiated liposarcomas and / or metastatic.

primary_purpose: Treatment

ReferenceType: result

ReferenceCitation: Toulmonde M, Le Cesne A, Piperno-Neumann S, Penel N, Chevreau C, Duffaud F, Bellera C, Italiano A. Aplidin in patients with advanced dedifferentiated liposarcomas: a French Sarcoma Group Single-Arm Phase II study. Ann Oncol. 2015 Jul;26(7):1465-70. doi: 10.1093/annonc/mdv195. Epub 2015 Jun 3.

family: Toulmonde

full_name: M. Toulmonde

given: M.

sequence: first

family: Le Cesne

full_name: A. Le Cesne

given: A.

sequence: additional

family: Piperno-Neumann

full_name: S. Piperno-Neumann

given: S.

family: Penel

full_name: N. Penel

given: N.

family: Chevreau

full_name: C. Chevreau

given: C.

family: Duffaud

full_name: F. Duffaud

given: F.

family: Bellera

full_name: C. Bellera

family: Italiano

full_name: A. Italiano

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annals of Oncology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: publishedVersion

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

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Institut Bergonié

location_facility:
Centre Léon Bérard
Centre Oscar Lambret
Hôpital de la Timone
Institut Claudius Regaud
Institut Curie
Institut Gustave Roussy

intervention_type: Drug

lead_sponsor_type: industriel


title: Interest of a Treatment With the alpha1-blocker Tamsulosin in the Elimination of Pelvis Ureteral Stones

acronym: TAMSULOSINE

summary: Ureteral stones have an important place in daily urological practice, usually causing acute episodes of ureteral colic by obstructing the urinary tract. The aim of the study is to evaluate whether repeated administration of tamsulosin, a drug routinely used in the treatment of lower urinary tract symptoms, could lower the delay of elimination of the stone in patients with pelvis ureterolithiasis.

design_allocation: Randomized

ReferenceType: background

ReferenceCitation: Resim S, Ekerbicer H, Ciftci A. Effect of tamsulosin on the number and intensity of ureteral colic in patients with lower ureteral calculus. Int J Urol. 2005 Jul;12(7):615-20.

ReferenceCitation: Wilde MI, McTavish D. Tamsulosin. A review of its pharmacological properties and therapeutic potential in the management of symptomatic benign prostatic hyperplasia. Drugs. 1996 Dec;52(6):883-98. Review.

ReferenceType: derived

ReferenceCitation: Vincendeau S, Bellissant E, Houlgatte A, Doré B, Bruyère F, Renault A, Mouchel C, Bensalah K, Guillé F; Tamsulosin Study Group. Tamsulosin hydrochloride vs placebo for management of distal ureteral stones: a multicentric, randomized, double-blind trial. Arch Intern Med. 2010 Dec 13;170(22):2021-7. doi: 10.1001/archinternmed.2010.447.

family: Vincendeau

full_name: Sébastien Vincendeau

given: Sébastien

journal_name: Archives of Internal Medicine

oa_host_type: publisher

evidence: open (via free pdf)

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

title: Tamsulosin Hydrochloride vs Placebo for Management of Distal Ureteral Stones

lead_sponsor: Rennes University Hospital

location_facility: Service d'Urologie - Hôpital de La Milétrie

location_facility: Service d'Urologie- Hôpital Robert Debré

location_facility: Service d'Urologie- Hôpital Pontchaillou

location_facility: Service d'Urologie- Hôpital du Val de Grâce


title: Cerebral Autoregulation in Pediatric ECMO (ECMOX 2) : Autoregul ECMO - ECMOX2

summary: Children supported by Extra-Corporeal Membrane Oxygenation (ECMO) present a high risk of neurological complications and cerebral autoregulation (CA) impairment may be a risk factor. The first objective is to investigate the association between CA impairments and neurological outcome assessed by the onset of an ANE. The secondary objective is to study the underlying mechanisms influencing CA.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Nantes University Hospital

location_country: Italy France

location_facility:
Giannina Gaslini Institute (IRCCS)
AP-HP Necker Hospital
AP-HP Trousseau Hospital
CHU de Nantes

status_simplified: Ongoing


title: French Post-Inscription Study on Sacral Neuromodulation in the Treatment of Fecal Incontinence

summary:
The aim of this observational study is to evaluate the utilization in the clinical practice, effectiveness, explantation and re-intervention rate, complications and adverse events of InterStim system in patients indicated to Sacral Neuromodulation therapy for fecal incontinence.

This study will provide additional data about safety and effectiveness of the usage of InterStim system in fecal incontinence environment and at the same time will confirm that results from clinical trials can be transposed to clinical practice.

ReferenceCitation: Matzel KE, Kamm MA, Stösser M, Baeten CG, Christiansen J, Madoff R, Mellgren A, Nicholls RJ, Rius J, Rosen H. Sacral spinal nerve stimulation for faecal incontinence: multicentre study. Lancet. 2004 Apr 17;363(9417):1270-6.

ReferenceCitation: Jarrett ME, Varma JS, Duthie GS, Nicholls RJ, Kamm MA. Sacral nerve stimulation for faecal incontinence in the UK. Br J Surg. 2004 Jun;91(6):755-61.

ReferenceCitation: Uludağ O, Koch SM, van Gemert WG, Dejong CH, Baeten CG. Sacral neuromodulation in patients with fecal incontinence: a single-center study. Dis Colon Rectum. 2004 Aug;47(8):1350-7.

ReferenceCitation: Altomare DF, Rinaldi M, Lobascio P, Marino F, Giuliani RT, Cuccia F. Factors affecting the outcome of temporary sacral nerve stimulation for faecal incontinence. The value of the new tined lead electrode. Colorectal Dis. 2011 Feb;13(2):198-202. doi: 10.1111/j.1463-1318.2009.02088.x.

ReferenceCitation: Mellgren A, Wexner SD, Coller JA, Devroede G, Lerew DR, Madoff RD, Hull T; SNS Study Group. Long-term efficacy and safety of sacral nerve stimulation for fecal incontinence. Dis Colon Rectum. 2011 Sep;54(9):1065-75. doi: 10.1097/DCR.0b013e31822155e9.

ReferenceCitation: Altomare DF, Ratto C, Ganio E, Lolli P, Masin A, Villani RD. Long-term outcome of sacral nerve stimulation for fecal incontinence. Dis Colon Rectum. 2009 Jan;52(1):11-7. doi: 10.1007/DCR.0b013e3181974444.

ReferenceCitation: Wexner SD, Coller JA, Devroede G, Hull T, McCallum R, Chan M, Ayscue JM, Shobeiri AS, Margolin D, England M, Kaufman H, Snape WJ, Mutlu E, Chua H, Pettit P, Nagle D, Madoff RD, Lerew DR, Mellgren A. Sacral nerve stimulation for fecal incontinence: results of a 120-patient prospective multicenter study. Ann Surg. 2010 Mar;251(3):441-9. doi: 10.1097/SLA.0b013e3181cf8ed0.

ReferenceCitation: Tjandra JJ, Chan MK, Yeh CH, Murray-Green C. Sacral nerve stimulation is more effective than optimal medical therapy for severe fecal incontinence: a randomized, controlled study. Dis Colon Rectum. 2008 May;51(5):494-502. doi: 10.1007/s10350-007-9103-5. Epub 2008 Feb 16.

ReferenceCitation: Leroi AM, Parc Y, Lehur PA, Mion F, Barth X, Rullier E, Bresler L, Portier G, Michot F; Study Group. Efficacy of sacral nerve stimulation for fecal incontinence: results of a multicenter double-blind crossover study. Ann Surg. 2005 Nov;242(5):662-9.

ReferenceCitation: Tan E, Ngo NT, Darzi A, Shenouda M, Tekkis PP. Meta-analysis: sacral nerve stimulation versus conservative therapy in the treatment of faecal incontinence. Int J Colorectal Dis. 2011 Mar;26(3):275-94. doi: 10.1007/s00384-010-1119-y. Epub 2011 Jan 29.

ReferenceCitation: Matzel KE, Lux P, Heuer S, Besendörfer M, Zhang W. Sacral nerve stimulation for faecal incontinence: long-term outcome. Colorectal Dis. 2009 Jul;11(6):636-41. doi: 10.1111/j.1463-1318.2008.01673.x. Epub 2008 Aug 21.

ReferenceCitation: Meurette G, Siproudhis L, Leroi AM, Damon H, Urs Josef Keller D, Faucheron JL; French Faecal Registry Study Group. Sacral neuromodulation with the InterStim™ system for faecal incontinence: results from a prospective French multicentre observational study. Colorectal Dis. 2021 Jun;23(6):1463-1473. doi: 10.1111/codi.15507. Epub 2021 Mar 12.

family: Meurette

full_name: Guillaume Meurette

given: Guillaume

family: Siproudhis

full_name: Laurent Siproudhis

given: Laurent

name: Hôpital Charles Nicolle CHU de Rouen Rouen France

family: Leroi

full_name: Anne‐Marie Leroi

given: Anne‐Marie

name: Hôpital Edouard Herriot CHU de Lyon Lyon France

family: Damon

full_name: Henri Damon

given: Henri

name: Medtronic Tolochenaz Tolochenaz Switzerland

family: Urs Josef Keller

full_name: David Urs Josef Keller

given: David

name: Hôpital Michallon CHU Grenoble Alpes France

family: Faucheron

full_name: Jean‐Luc Faucheron

given: Jean‐Luc

family: Lehur

full_name: Paul A. Lehur

given: Paul A.

family: Orsoni

full_name: Pierre Charles Orsoni

given: Pierre Charles

family: Bridoux

full_name: Valerie Bridoux

given: Valerie

family: Zerbib

full_name: Philippe Zerbib

given: Philippe

family: Dubois

full_name: Anne Dubois

given: Anne

family: Rohr

full_name: Serge Rohr

given: Serge

family: Barussaud

full_name: Marie‐line Barussaud

given: Marie‐line

family: Mathonnet

full_name: Muriel Mathonnet

given: Muriel

family: Loriau

full_name: Jérôme Loriau

given: Jérôme

family: Etienney

full_name: Isabelle Etienney

given: Isabelle

family: Gravie

full_name: Jean Francois Gravie

given: Jean Francois

family: Portier

full_name: Guillaume Portier

family: Escartin

full_name: Michel Escartin

given: Michel

journal_name: Colorectal Disease

publisher: Wiley

location_facility:
CHU Hautepierre
Clinique St Jean du Languedoc
CHU Grenoble - Hôpital Michallon
Polyclinique Pays Basque Sud
CHU La Milétrie
GH Diaconesses Croix St Simon
CHU Dupuytren
CHU Toulouse - Hotel Dieu PURPAN
CHRU Lille - Hôpital Claude Huriez
CHU Estaing
Hopital Edouard Herriot
Hôpital Saint Joseph
CHU Rennes - Hôpital Pontchaillou
CHU Charles Nicolle
CHU Nantes - Hotel Dieu
APM Hopital Nord


title: Immuno-Génétique, Inflammation, Retro-Virus, Environnement

acronym: I-Give

summary:
Immunology combined to neurobiology now offer prominent tools to yield biomarkers, so far missing in psychiatry, and to design innovative treatment approaches based on the discovery of new molecular and cellular targets. As Bipolar Disorder and Schizophrenia are now known to be significantly associated with neuro-inflammation, the project I-GIVE will combine multidisciplinary approaches (clinical, viral, immunological, genetic) to explore a global hypothesis placing the Human Endogenous Retro-Virus, HERV-W, at the crossroads between susceptibility to environmental factors (such as winter-spring births, infections, urbanicity…) and genetic factors controlling immune responses.

Thus I-GIVE will allow identification of new biomarkers and their correlation with clinical profiles and immuno-inflammatory/immuno-genetic markers, and description of patho-physiological mechanisms of a psychiatric disorder. In addition, I-GIVE should help to design innovative treatments and foster personalized psychiatry tailored to the needs of each patient. Notably, monoclonal antibodies anti-HERV-W Env will be assessed in a preclinical model for their ability to slow, stop, or even reverse the progression of the psychosis in patients. I-GIVE project should thus lead to major results that will have strong impacts on the scientific community, pharmaceutical industries and, in a longer term, on improvement of patients suffering Bipolar Disorder or Schizophrenia and their family.

status: Unknown status

design_allocation: Non-Randomized

primary_purpose: Basic Science

lead_sponsor: Pr. Marion Leboyer

location_facility: Clinical Investigations Center of Mondor Hospital

location_facility: Psychiatry Department of Mondor Hospital

location_facility: Psychiatry Department of Perrens Hospital

location_facility: Psychiatry Department of R. Dubos Hospital

intervention_type: Genetic


title: Phase I/II Study of LY2228820 With Radiotherapy Plus Concomitant TMZ in the Treatment of Newly Diagnosed Glioblastoma

acronym: GLYRad

summary:
Glioblastomas are extremely resistant to treatment, including radiotherapy and/or chemotherapy. Mitogen-activated protein kinase (MAPK) cascades are key signaling pathways involved in the regulation of normal cell proliferation, survival and differentiation. Activation of p38 MAPK has been associated with a poor prognosis among patients with glioblastoma during the temozolomide (TMZ) era and represents a compensatory response by tumor cell to environmental stress such as radiation or chemotherapy.

LY2228820 is a potent and selective inhibitor of p38 MAPK, and reduces phosphorylation of its cellular target, MAPK-activated protein kinase 2 (MAPKAPK-2) . LY2228820 is a good candidate to target malignant glioma resistance to the gold standard treatment combining radiation and TMZ by acting on both tumor and stromal cells.

The primary objectives of this study were to determine the recommended dose of LY2228820 in combination with TMZ and radiotherapy during chemoradiotherapy period (phase I) and to estimate the 6-month progression free survival (PFS) rate of patients treated with LY2228820 when administered at the recommended dose in combination with radiotherapy and concomitant TMZ (phase II)

lead_sponsor: Centre Jean Perrin

location_facility:
Centre François Baclesse
CHU Amiens Sud-Salouel
Centre Georges François Leclerc
Centre Jean Perrin
Centre Paul Strauss
Institut Bergonié

intervention_type: Radiation


title: Acrobat Coronary Stent System Effectiveness European Study (European Multicenter Effectiveness Randomized Study of Svelte Medical Systems Acrobat Stent on a Wire Compared to Other BMS PCI in de Novo Coronary Lesions) ACES Trial

acronym: ACES

summary: The purpose of this randomized controlled trial (RCT) is to demonstrate the clinical benefit and impact on resource utilization of percutaneous coronary interventions (PCI) with the Svelte Acrobat Stent System compared to any other CE marked bare metal stent (BMS) implantable via direct stenting or after lesion pre-dilation, in patients with coronary lesions that are eligible for direct stenting and who are recruited and treated so as to reflect real-life routine practice.

ReferenceCitation: Piscione F, Piccolo R, Cassese S, Galasso G, D'Andrea C, De Rosa R, Chiariello M. Is direct stenting superior to stenting with predilation in patients treated with percutaneous coronary intervention? Results from a meta-analysis of 24 randomised controlled trials. Heart. 2010 Apr;96(8):588-94. doi: 10.1136/hrt.2009.183277. Review.

ReferenceCitation: Shao C, Stella PR, Agostoni P. Complex made easy: left anterior descending artery trifurcation lesion completely treated with a single device. J Invasive Cardiol. 2012 Aug;24(8):E164-6.

ReferenceCitation: de Ribamar Costa J, Abizaid A, Stella P, Fernandez A, Granada J, Feres F, Serruys P. Preliminary results of the svelte trial: first-in-man assessment of the novel acrobat™ SOAW (Stent-On-A-Wire) coronary system. J Am Coll Cardiol. 2011;57(14s1):E1658-E1658. doi:10.1016/S0735-1097(11)61658-6

lead_sponsor: Svelte Medical Systems Europe

location_country: Belgium France Spain

location_facility: CHU Bordeaux Sud - Hôpital Cardiologique Haut Lévêque

intervention_type: Device


title: Evaluation of a Strategy Guided by Imaging Versus Systematic Coronary Angiography in Elderly Patients With Ischemia: a Multicentric Randomized Non Inferiority Trial.

acronym: EVAOLD

summary:
The WHO predicts that cardiovascular morbi-mortality will increase by 120-137% within 20 years due to the aging population. Myocardial infarction without ST segment elevation (NSTEMI) is the most common form of infarction. However, its treatment among elderly patients remains a challenging question.

Indeed, the risk benefit balance of revascularization remains unclear, and complications related to revascularization are more frequent in the elderly, including MI, heart failure, stroke, renal failure and bleeding according to National Cardiovascular Network data.The last randomized controlled trial "After Eighty Study", showed a reduction of major cardio-cerebrovascular events (MACCEs) in NSTEMI patients with an invasive strategy (systematic coronary angiography - CA) compared to a conservative strategy (medical treatment alone). Nevertheless, this study presented several limitations of which a major one was the lack of a definition of frailty at inclusion. Moreover, the "After Eighty Study" has shown that percutaneous revascularization in the invasive arm was only performed for 1 in 2 patients showing an inadequacy in the strategy for selecting candidates for revascularization.

Consequently, despite European Society of Cardiology (ESC) guidelines, the management of NSTEMI in elderly patients is not yet evidence based, and current recommendations do not provide any clear clinical decision rule indicating one strategy over another.

For fragile patients, an alternative strategy consists of selecting candidates for a guided CA according to the extent of myocardial ischemia, identified by non-invasive imaging. Single-photon emission computed tomography or dobutamine stress echocardiograms are currently the reference methods with well-defined interpretation of ischemia. According to our experience, this strategy avoids CA for one third of patients and improves the rate of revascularization.

The aim of our study is to compare 1-year morbidity and mortality in NSTEMI patients over 80 years, assigned to guided versus systematic-CA. Our hypothesis is that the guided strategy will not be inferior on MACE rates at 1 year, and will be cost-effective by reducing iatrogenic complications.

ReferenceCitation: Batchelor WB, Anstrom KJ, Muhlbaier LH, Grosswald R, Weintraub WS, O'Neill WW, Peterson ED. Contemporary outcome trends in the elderly undergoing percutaneous coronary interventions: results in 7,472 octogenarians. National Cardiovascular Network Collaboration. J Am Coll Cardiol. 2000 Sep;36(3):723-30.

ReferenceCitation: Bauer T, Koeth O, Jünger C, Heer T, Wienbergen H, Gitt A, Zahn R, Senges J, Zeymer U; Acute Coronary Syndromes Registry (ACOS) Investigators. Effect of an invasive strategy on in-hospital outcome in elderly patients with non-ST-elevation myocardial infarction. Eur Heart J. 2007 Dec;28(23):2873-8. Epub 2007 Nov 2.

ReferenceCitation: Rosengren A, Wallentin L, Simoons M, Gitt AK, Behar S, Battler A, Hasdai D. Age, clinical presentation, and outcome of acute coronary syndromes in the Euroheart acute coronary syndrome survey. Eur Heart J. 2006 Apr;27(7):789-95. Epub 2006 Feb 7.

ReferenceCitation: Wiviott SD, Braunwald E, McCabe CH, Montalescot G, Ruzyllo W, Gottlieb S, Neumann FJ, Ardissino D, De Servi S, Murphy SA, Riesmeyer J, Weerakkody G, Gibson CM, Antman EM; TRITON-TIMI 38 Investigators. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2007 Nov 15;357(20):2001-15. Epub 2007 Nov 4.

ReferenceCitation: Alexander KP, Anstrom KJ, Muhlbaier LH, Grosswald RD, Smith PK, Jones RH, Peterson ED. Outcomes of cardiac surgery in patients > or = 80 years: results from the National Cardiovascular Network. J Am Coll Cardiol. 2000 Mar 1;35(3):731-8.

ReferenceCitation: Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators, Freij A, Thorsén M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.

family: Wallentin

full_name: Lars Wallentin

given: Lars

family: Becker

full_name: Richard C. Becker

given: Richard C.

family: Budaj

full_name: Andrzej Budaj

given: Andrzej

family: Cannon

full_name: Christopher P. Cannon

given: Christopher P.

family: Emanuelsson

full_name: Håkan Emanuelsson

given: Håkan

family: Held

full_name: Claes Held

given: Claes

family: Horrow

full_name: Jay Horrow

given: Jay

family: Husted

full_name: Steen Husted

given: Steen

family: James

full_name: Stefan James

given: Stefan

family: Katus

full_name: Hugo Katus

given: Hugo

family: Mahaffey

full_name: Kenneth W. Mahaffey

given: Kenneth W.

family: Scirica

full_name: Benjamin M. Scirica

given: Benjamin M.

family: Skene

full_name: Allan Skene

given: Allan

family: Steg

full_name: Philippe Gabriel Steg

given: Philippe Gabriel

family: Storey

full_name: Robert F. Storey

given: Robert F.

family: Harrington

full_name: Robert A. Harrington

given: Robert A.

journal_name: New England Journal of Medicine

oa_host_type: repository

repository_institution: University of Debrecen - University of Debrecen Electronic Archive

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Ticagrelor versus Clopidogrel in Patients with Acute Coronary Syndromes

ReferenceCitation: Wallentin L, Lagerqvist B, Husted S, Kontny F, Ståhle E, Swahn E. Outcome at 1 year after an invasive compared with a non-invasive strategy in unstable coronary-artery disease: the FRISC II invasive randomised trial. FRISC II Investigators. Fast Revascularisation during Instability in Coronary artery disease. Lancet. 2000 Jul 1;356(9223):9-16.

ReferenceCitation: Lagerqvist B, Husted S, Kontny F, Ståhle E, Swahn E, Wallentin L; Fast Revascularisation during InStability in Coronary artery disease (FRISC-II) Investigators. 5-year outcomes in the FRISC-II randomised trial of an invasive versus a non-invasive strategy in non-ST-elevation acute coronary syndrome: a follow-up study. Lancet. 2006 Sep 16;368(9540):998-1004.

ReferenceCitation: Fox KA, Clayton TC, Damman P, Pocock SJ, de Winter RJ, Tijssen JG, Lagerqvist B, Wallentin L; FIR Collaboration. Long-term outcome of a routine versus selective invasive strategy in patients with non-ST-segment elevation acute coronary syndrome a meta-analysis of individual patient data. J Am Coll Cardiol. 2010 Jun 1;55(22):2435-45. doi: 10.1016/j.jacc.2010.03.007. Epub 2010 Mar 30. Review.

family: Fox

full_name: Keith A.A. Fox

given: Keith A.A.

family: Clayton

full_name: Tim C. Clayton

journal_name: Journal of the American College of Cardiology

title: Long-Term Outcome of a Routine Versus Selective Invasive Strategy in Patients With Non–ST-Segment Elevation Acute Coronary Syndrome

ReferenceCitation: Savonitto S, Cavallini C, Petronio AS, Murena E, Antonicelli R, Sacco A, Steffenino G, Bonechi F, Mossuti E, Manari A, Tolaro S, Toso A, Daniotti A, Piscione F, Morici N, Cesana BM, Jori MC, De Servi S; Italian Elderly ACS Trial Investigators. Early aggressive versus initially conservative treatment in elderly patients with non-ST-segment elevation acute coronary syndrome: a randomized controlled trial. JACC Cardiovasc Interv. 2012 Sep;5(9):906-16. doi: 10.1016/j.jcin.2012.06.008.

title: Early Aggressive Versus Initially Conservative Treatment in Elderly Patients With Non–ST-Segment Elevation Acute Coronary Syndrome

ReferenceCitation: Tegn N, Abdelnoor M, Aaberge L, Endresen K, Smith P, Aakhus S, Gjertsen E, Dahl-Hofseth O, Ranhoff AH, Gullestad L, Bendz B; After Eighty study investigators. Invasive versus conservative strategy in patients aged 80 years or older with non-ST-elevation myocardial infarction or unstable angina pectoris (After Eighty study): an open-label randomised controlled trial. Lancet. 2016 Mar 12;387(10023):1057-1065. doi: 10.1016/S0140-6736(15)01166-6. Epub 2016 Jan 13.

ReferenceCitation: Afilalo J, Alexander KP, Mack MJ, Maurer MS, Green P, Allen LA, Popma JJ, Ferrucci L, Forman DE. Frailty assessment in the cardiovascular care of older adults. J Am Coll Cardiol. 2014 Mar 4;63(8):747-62. doi: 10.1016/j.jacc.2013.09.070. Epub 2013 Nov 27. Review.

title: Frailty Assessment in the Cardiovascular Care of Older Adults

ReferenceCitation: Ekerstad N, Swahn E, Janzon M, Alfredsson J, Löfmark R, Lindenberger M, Carlsson P. Frailty is independently associated with short-term outcomes for elderly patients with non-ST-segment elevation myocardial infarction. Circulation. 2011 Nov 29;124(22):2397-404. doi: 10.1161/CIRCULATIONAHA.111.025452. Epub 2011 Nov 7.

name: From the Center for Medical Technology Assessment/Department of Medical and Health Sciences, Linköping University, Linköping (N.E., P.C.); Division of Cardiovascular Medicine, Department of Medicine and Health Sciences, Faculty of Health Sciences, Linköping University, and Department of Cardiology, University Hospital of Linköping, County Council of Östergötland, Linköping (E.S., M.J., J.A.); Department of Medical Ethics, LIME, Karolinska Institutet, Stockholm (R.L.); Department of Medicine, Ryhov...

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Frailty Is Independently Associated With Short-Term Outcomes for Elderly Patients With Non–ST-Segment Elevation Myocardial Infarction

ReferenceCitation: Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S. [2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC)]. G Ital Cardiol (Rome). 2016 Oct;17(10):831-872. doi: 10.1714/2464.25804. Italian.

ReferenceCitation: Task Force Members, Montalescot G, Sechtem U, Achenbach S, Andreotti F, Arden C, Budaj A, Bugiardini R, Crea F, Cuisset T, Di Mario C, Ferreira JR, Gersh BJ, Gitt AK, Hulot JS, Marx N, Opie LH, Pfisterer M, Prescott E, Ruschitzka F, Sabaté M, Senior R, Taggart DP, van der Wall EE, Vrints CJ; ESC Committee for Practice Guidelines, Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers, Knuuti J, Valgimigli M, Bueno H, Claeys MJ, Donner-Banzhoff N, Erol C, Frank H, Funck-Brentano C, Gaemperli O, Gonzalez-Juanatey JR, Hamilos M, Hasdai D, Husted S, James SK, Kervinen K, Kolh P, Kristensen SD, Lancellotti P, Maggioni AP, Piepoli MF, Pries AR, Romeo F, Rydén L, Simoons ML, Sirnes PA, Steg PG, Timmis A, Wijns W, Windecker S, Yildirir A, Zamorano JL. 2013 ESC guidelines on the management of stable coronary artery disease: the Task Force on the management of stable coronary artery disease of the European Society of Cardiology. Eur Heart J. 2013 Oct;34(38):2949-3003. doi: 10.1093/eurheartj/eht296. Epub 2013 Aug 30. Erratum in: Eur Heart J. 2014 Sep 1;35(33):2260-1.

ReferenceCitation: Thygesen K, Alpert JS, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction. Universal definition of myocardial infarction. J Am Coll Cardiol. 2007 Nov 27;50(22):2173-95.

ReferenceCitation: Manrique A, Marie PY, Agostini D, Maunoury C, Acar P; Groupe de travail Cardiologie nucléaire et IRM. [Update of recommendations for nuclear cardiology stress tests in adults and children]. Arch Mal Coeur Vaiss. 2002 Sep;95(9):851-72. French.

ReferenceCitation: Furber A, Berdagué P, Cadiou C, David N, Faraggi M, Fourquet N, Hélias J, Le Guludec D, Marie PY, Ouhayoun E, Pézard P, Vanzetto G, Weinmann P; Groupe de travail Cardiologie nucléaire et IRM. [Recommendations of the French Society of Cardiology concerning the practice of ischemia provocation tests in adult nuclear cardiology]. Arch Mal Coeur Vaiss. 2000 Nov;93(11):1309-32. French.

ReferenceCitation: Manrique A, Marie PY; Nuclear Cardiology MRI Group. [Recommendations for the performance and interpretation of myocardial perfusion tomoscintigraphy]. Arch Mal Coeur Vaiss. 2003 Jun;96(6):695-711. French.

ReferenceCitation: Verberne HJ, Acampa W, Anagnostopoulos C, Ballinger J, Bengel F, De Bondt P, Buechel RR, Cuocolo A, van Eck-Smit BL, Flotats A, Hacker M, Hindorf C, Kaufmann PA, Lindner O, Ljungberg M, Lonsdale M, Manrique A, Minarik D, Scholte AJ, Slart RH, Trägårdh E, de Wit TC, Hesse B; European Association of Nuclear Medicine (EANM). EANM procedural guidelines for radionuclide myocardial perfusion imaging with SPECT and SPECT/CT: 2015 revision. Eur J Nucl Med Mol Imaging. 2015 Nov;42(12):1929-40. doi: 10.1007/s00259-015-3139-x. Epub 2015 Aug 21.

journal_name: European Journal of Nuclear Medicine and Molecular Imaging

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repository_institution: Lund University - Lund University Publications

ReferenceCitation: Cerqueira MD, Weissman NJ, Dilsizian V, Jacobs AK, Kaul S, Laskey WK, Pennell DJ, Rumberger JA, Ryan T, Verani MS; American Heart Association Writing Group on Myocardial Segmentation and Registration for Cardiac Imaging. Standardized myocardial segmentation and nomenclature for tomographic imaging of the heart. A statement for healthcare professionals from the Cardiac Imaging Committee of the Council on Clinical Cardiology of the American Heart Association. Int J Cardiovasc Imaging. 2002 Feb;18(1):539-42. Review.

ReferenceCitation: Sicari R, Nihoyannopoulos P, Evangelista A, Kasprzak J, Lancellotti P, Poldermans D, Voigt JU, Zamorano JL; European Association of Echocardiography. Stress Echocardiography Expert Consensus Statement--Executive Summary: European Association of Echocardiography (EAE) (a registered branch of the ESC). Eur Heart J. 2009 Feb;30(3):278-89. doi: 10.1093/eurheartj/ehn492. Epub 2008 Nov 11. Review.

name: on behalf of the European Association of Echocardiography

ReferenceCitation: Lang RM, Bierig M, Devereux RB, Flachskampf FA, Foster E, Pellikka PA, Picard MH, Roman MJ, Seward J, Shanewise JS, Solomon SD, Spencer KT, Sutton MS, Stewart WJ; Chamber Quantification Writing Group; American Society of Echocardiography's Guidelines and Standards Committee; European Association of Echocardiography. Recommendations for chamber quantification: a report from the American Society of Echocardiography's Guidelines and Standards Committee and the Chamber Quantification Writing Group, developed in conjunction with the European Association of Echocardiography, a branch of the European Society of Cardiology. J Am Soc Echocardiogr. 2005 Dec;18(12):1440-63.

ReferenceCitation: Authors/Task Force members, Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Jüni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29.

ReferenceCitation: Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449.

name: The BARC represents a collaboration of independent academic research organizations (Cardialysis, Rotterdam, the Netherlands; Cardiovascular Research Foundation, New York City, NY; Duke Clinical Research Institute, Durham, NC; TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, and Harvard Medical School, Boston, MA; Harvard Clinical Research Institute, Boston, MA; Green Lane Coordinating Centre, Auckland, New Zealand; Cleveland Clinic Coordinating Center for Clinical Research,...

title: Standardized Bleeding Definitions for Cardiovascular Clinical Trials

ReferenceCitation: Lakatos E, Lan KK. A comparison of sample size methods for the logrank statistic. Stat Med. 1992 Jan 30;11(2):179-91.

ReferenceCitation: Com-Nougue C, Rodary C, Patte C. How to establish equivalence when data are censored: a randomized trial of treatments for B non-Hodgkin lymphoma. Stat Med. 1993 Jul 30;12(14):1353-64.

ReferenceCitation: Rothmann M, Li N, Chen G, Chi GY, Temple R, Tsou HH. Design and analysis of non-inferiority mortality trials in oncology. Stat Med. 2003 Jan 30;22(2):239-64.

ReferenceCitation: Fleming TR, Harrington DP, O'Brien PC. Designs for group sequential tests. Control Clin Trials. 1984 Dec;5(4):348-61.

ReferenceCitation: Chevalier J, de Pouvourville G. Valuing EQ-5D using time trade-off in France. Eur J Health Econ. 2013 Feb;14(1):57-66. doi: 10.1007/s10198-011-0351-x. Epub 2011 Sep 21.

journal_name: The European Journal of Health Economics

title: Valuing EQ-5D using Time Trade-Off in France

ReferenceCitation: Manca A, Hawkins N, Sculpher MJ. Estimating mean QALYs in trial-based cost-effectiveness analysis: the importance of controlling for baseline utility. Health Econ. 2005 May;14(5):487-96.

ReferenceCitation: Sullivan SD, Mauskopf JA, Augustovski F, Jaime Caro J, Lee KM, Minchin M, Orlewska E, Penna P, Rodriguez Barrios JM, Shau WY. Budget impact analysis-principles of good practice: report of the ISPOR 2012 Budget Impact Analysis Good Practice II Task Force. Value Health. 2014 Jan-Feb;17(1):5-14. doi: 10.1016/j.jval.2013.08.2291. Epub 2013 Dec 13.

title: Budget Impact Analysis—Principles of Good Practice: Report of the ISPOR 2012 Budget Impact Analysis Good Practice II Task Force

location_facility:
Clinique Mutualiste
University Hospital Grenoble


title: Chair Rise Tests for a Simplified Evaluation of Functional Response After a Rehabilitation Program in Patients COPD.

summary:
Improvement in the functional functioning and dyspnea of COPD patients after a rehabilitation program (RHB) is assessed by exercise tests and questionnaires difficult to replicate outside specialized centers.

In order to monitor the eventual decline of patients in the course of their RHB management, Chair Rise Tests (3CRT-1CRT-5STS) and short questionnaires were developed (CAT-DIRECT). The goal of this prospective, multicenter, real-life study is to compare the change in several functional function tests and questionnaires of quality of life and dyspnea related to daily activities. In addition, MCIDs of the 3CRT and the DIRECT questionnaire (Disability Related to COPS Tool) were specified.

ReferenceCitation: Lévesque J, Antoniadis A, Li PZ, Herengt F, Brosson C, Grosbois JM, Bernady A, Bender A, Favre M, Guerder A, Surpas P, Similowski T, Aguilaniu B. Minimal clinically important difference of 3-minute chair rise test and the DIRECT questionnaire after pulmonary rehabilitation in COPD patients. Int J Chron Obstruct Pulmon Dis. 2019 Jan 22;14:261-269. doi: 10.2147/COPD.S187567. eCollection 2019.

family: Lévesque

full_name: Jonathan Lévesque

given: Jonathan

family: Antoniadis

full_name: Anestis Antoniadis

given: Anestis

family: Li

full_name: Pei Zhi Li

given: Pei Zhi

family: Herengt

full_name: Frédéric Herengt

given: Frédéric

family: Brosson

full_name: Christophe Brosson

given: Christophe

family: Grosbois

full_name: Jean-Marie Grosbois

given: Jean-Marie

family: Bernady

full_name: Alain Bernady

given: Alain

family: Bender

full_name: Anthony Bender

given: Anthony

family: Favre

full_name: Murielle Favre

given: Murielle

family: Guerder

full_name: Antoine Guerder

given: Antoine

family: Surpas

full_name: Pascale Surpas

given: Pascale

family: Similowski

full_name: Thomas Similowski

given: Thomas

family: Aguilaniu

full_name: Bernard Aguilaniu

given: Bernard

currency_apc_doaj: USD

journal_name: International Journal of Chronic Obstructive Pulmonary Disease

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

lead_sponsor: University Hospital, Lille

location_facility:
Centre Hospitalier Universitaire
Hôpital Calmette, CHRU

intervention_type: Diagnostic Test


title: Prognostic Factors and the Impact of Various Management of Acute Myeloid Leukemia in Real Life Condition at Toulouse and Bordeaux University Hospital

acronym: LAM-BDD

summary: The treatment of older patients with acute myeloid leukemia that is secondary to previous myelodysplastic syndrome, myeloproliferative neoplasm, or prior cytotoxic exposure remains unsatisfactory. We compared patients treated with intensive chemotherapy or azacitidine within two centres.

status: Active, not recruiting

time_perspective: Retrospective

lead_sponsor: University Hospital, Toulouse

location_facility:
University Hospital Bordeaux
University Hospital Toulouse


title: Effects of Dapagliflozin on Lipoprotein Kinetics in Patients With Type 2 Diabetes

acronym: Cinétique DAPA

summary:
This study will make it possible to better understand the mechanisms responsible for the increase in bad cholesterol levels observed in patients with type 2 diabetes treated with Dapagliflozin, an antidiabetic treatment made by Astrazeneca.

The information will:

reveal what is not working properly
make it possible to choose the most appropriate treatments against cholesterol to compensate for this impaired functioning

This biomedical research will take place at the University Hospitals of DIJON and NANTES.

28 patients will take part: 20 patients will be given Dapagliflozin and 8 patients will be given the placebo.
The study treatment will be randomised: patients will be given either Dapagliflozin or the placebo. The treatment duration is 6 months.
Moreover, during the inclusion visit and at the end of the study (6 months after the start of treatment), a kinetics study, to follow the production and elimination of cholesterol, will be conducted. This will involve administering amino acids that have been specifically synthesised for this purpose.
Participation in the study will last 6 months and include 4 protocol visits.

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility:
CHU Dijon Bourgogne
CHU de Nantes


ReferenceCitation: Minard-Colin V, Aupérin A, Pillon M, Burke GAA, Barkauskas DA, Wheatley K, Delgado RF, Alexander S, Uyttebroeck A, Bollard CM, Zsiros J, Csoka M, Kazanowska B, Chiang AK, Miles RR, Wotherspoon A, Adamson PC, Vassal G, Patte C, Gross TG; European Intergroup for Childhood Non-Hodgkin Lymphoma; Children's Oncology Group. Rituximab for High-Risk, Mature B-Cell Non-Hodgkin's Lymphoma in Children. N Engl J Med. 2020 Jun 4;382(23):2207-2219. doi: 10.1056/NEJMoa1915315.

name: From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke’s...

family: Minard-Colin

full_name: Véronique Minard-Colin

given: Véronique

family: Aupérin

full_name: Anne Aupérin

given: Anne

family: Pillon

full_name: Marta Pillon

given: Marta

family: Burke

full_name: G.A. Amos Burke

given: G.A. Amos

family: Barkauskas

full_name: Donald A. Barkauskas

given: Donald A.

family: Wheatley

full_name: Keith Wheatley

given: Keith

family: Delgado

full_name: Rafael F. Delgado

given: Rafael F.

family: Alexander

full_name: Sarah Alexander

given: Sarah

family: Uyttebroeck

full_name: Anne Uyttebroeck

family: Bollard

full_name: Catherine M. Bollard

given: Catherine M.

family: Zsiros

full_name: József Zsiros

given: József

family: Csoka

full_name: Monika Csoka

given: Monika

family: Kazanowska

full_name: Bernarda Kazanowska

given: Bernarda

family: Chiang

full_name: Alan K. Chiang

given: Alan K.

family: Miles

full_name: Rodney R. Miles

given: Rodney R.

family: Wotherspoon

full_name: Andrew Wotherspoon

given: Andrew

family: Adamson

full_name: Peter C. Adamson

given: Peter C.

family: Vassal

full_name: Gilles Vassal

given: Gilles

family: Patte

full_name: Catherine Patte

given: Catherine

family: Gross

full_name: Thomas G. Gross

given: Thomas G.

oa_colors: green other

evidence: open (via free article)

version: acceptedVersion

title: Rituximab for High-Risk, Mature B-Cell Non-Hodgkin’s Lymphoma in Children

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_country:
Italy
Netherlands
Spain
France
Poland
Hungary
Belgium
China
Canada
United Kingdom

location_facility: The University of Hong Kong (Clinical Trials Centre)

location_facility: Sociedad Española de Hematología y Oncología Pediátricas

location_facility: Associazione Italiana di Ematologia ed Oncologia Pediatrica

location_facility: 2nd Dept. of Pediatrics Semmelweis Univ.

location_facility: Children Oncology Group Operations centres

title: Intergroup Trial for Children or Adolescents With B-Cell Non Hodgkin Lymphoma or B-Acute Leukemia: Evaluation of Rituximab Efficacy and Safety in High Risk Patients - Phase III Trial

summary: The aim of the trial is to test whether adding 6 injections of rituximab to standard "Lymphome malin B" LMB chemotherapy regimen improves the Event Free Survival (EFS) compared with LMB chemotherapy alone in children / adolescents with advanced stage B-cell Non-Hodgkin Lymphoma (NHL) / B-Acute Leukemia (B-AL)(stage III and LDH > Nx2, any stage IV or B-AL).


lead_sponsor: Sanofi

primary_purpose: Prevention

location_country:
Romania
Australia
Russian Federation
Czech Republic
Ukraine
India
France
Lithuania
Canada
Korea, Republic of
Netherlands
Hungary
United States
Germany
United Kingdom
Italy
Austria
Mexico
New Zealand
Spain
Estonia
Latvia

acronym: SAVE-VEMED

location_facility: sanofi-aventis Australia & New Zealand administrative office

type: EudraCT Number

source: euctr

title: A Multinational, Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of AVE5026 With Enoxaparin for the Primary Prevention of Venous Thromboembolism in Acutely Ill Medical Patients With Restricted Mobility

summary:
The primary objective was to compare the efficacy of once daily [q.d] subcutaneous [s.c.] injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for the primary prevention of Venous Thromboembolic Events [VTE] in patients hospitalized for acute medical illness.

The secondary objectives were to evaluate the safety of AVE5026 and to document AVE5026 exposure in this population.


title: Phase II Study of Iberdomide (Cc220) Maintenance After Autologous Stem Cell Transplantation in Newly Diagnosed Multiple Myeloma Patients

summary: This is a phase II study to evaluate the efficacy and safety of different doses of iberdomide continuous therapy as maintenancetreatment after transplant.

lead_sponsor: European Myeloma Network

location_country: Italy France Netherlands Greece

location_facility: Vrije Universiteit Medical Center (VUMC)

location_facility: Alexandra General Hospital -Department of Clinical Therapeutics N.K. Univ. of Athens

location_facility: CHU Hôtel-Dieu, 1, place Alexis Ricordeau, 44093 NANTES Cedex 1, FRANCE

location_facility: Ospedale Generale Regionale-Divisione di Ematologia e Centro Trapianto Midollo Osseo


title: Impact of a Personalized Video in Oral Hygiene Motivation

acronym: GOPERIO

summary: Impact of a personalized video in oral hygiene motivation: The study hypothesis is that the use of a personalized oral hygiene video, made available to the patient via a cloud-based system, in conjunction with a text-based two-way recall system will increase patient compliance, hence leading to improvement or oral hygiene.

ReferenceCitation: Garyga V, Pochelu F, Thivichon-Prince B, Aouini W, Santamaria J, Lambert F, Maucort-Boulch D, Gueyffier F, Gritsch K, Grosgogeat B. GoPerio - impact of a personalized video and an automated two-way text-messaging system in oral hygiene motivation: study protocol for a randomized controlled trial. Trials. 2019 Dec 10;20(1):699. doi: 10.1186/s13063-019-3738-0.

apc_source: openAPC

family: Garyga

full_name: Valentin Garyga

given: Valentin

family: Pochelu

full_name: Florian Pochelu

given: Florian

family: Thivichon-Prince

full_name: Béatrice Thivichon-Prince

given: Béatrice

family: Aouini

full_name: Walid Aouini

given: Walid

family: Santamaria

full_name: Julie Santamaria

given: Julie

family: Lambert

full_name: France Lambert

given: France

family: Maucort-Boulch

full_name: Delphine Maucort-Boulch

given: Delphine

family: Gueyffier

full_name: Francois Gueyffier

given: Francois

family: Gritsch

full_name: Kerstin Gritsch

given: Kerstin

family: Grosgogeat

full_name: Brigitte Grosgogeat

given: Brigitte

currency_apc_doaj: GBP

journal_name: Trials

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

location_country: Belgium France

location_facility: Hospices Civils de Lyon - Service de Consultations et de Traitements Dentaires


title: Correlation Between Tissue and Plasmatic EGFR in CBNPC With EGFR Mutation or Predictive Factor of EGFR Mutation

acronym: CONCORDE

summary: Condorde main objective is to evaluate the correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed on ctDNA after liquid biopsy. EGFR status will be assessed by real time PCR (rtPCR), digital PCR (dPCR) and Next Generation Sequencing (NGS) in patients with chemotherapy naive lung carcinoma.

lead_sponsor: Centre Oscar Lambret

location_facility:
CHRU Lille
Centre Oscar Lambret

intervention_type: Procedure


title: Genomic Screening for Hereditary Erythrocytosis and Related Diseases

acronym: GENRED

summary:
Unexplained polycythemias are rare diseases, and therefore, the collection of data inherent to these diseases will not only improve their characterisation, but also allow stratification according to the risks and the course of the disease. The objective of this project is to constitute a database on the disease which will allow us to better understand it and in due course improve its management.

The GENRED project thus bears uniquely on the collection of information, which will be gathered throughout the usual management of patients for this type of disease.

location_facility:
CHU Dijon Bourgogne
CHU de NANTES


title: Impact of Preoperative Martial Deficiency on the Level of Blood Transfusion in Programmed Cardiac Surgery (CARMATS)

acronym: CARMATS

summary: Observational study.

location_facility:
Brest University Hospital
Rennes University Hospital


title: Hypertension Disorders During Pregnancy and Multi-exposure to Environmental Noise and Atmospheric Pollution in an Urban Setting: Case-control Study in Women Who Gave Birth at Dijon and Besançon CHUs Between 2005 and 2009

acronym: HTA-BQuA

summary:
This retrospective study aimed to analyse the relationship between multi-exposure to noise and air pollution the onset of hypertension disorders during pregnancy

It will be conducted in 2650 mothers who gave birth at Dijon or Besançon CHU between 2005 and 2009 split into two groups:

530 cases (women who experienced hypertension disorders during pregnancy
2120 controls (women who did not experience a hypertension disorder during pregnancy)

location_facility:
CHU de BESANCON
CHU Dijon Bourgogne


title: Combined Therapy of Hypnosis Kinesitherapy and MEOPA in Patients With Regional Painful Syndrome Complex

acronym: ProHKM-SDRC

summary: Relation between hypnosis and MEOPA on algodystrophy.

primary_purpose: Supportive Care

ReferenceCitation: Oerlemans HM, Oostendorp RA, de Boo T, Perez RS, Goris RJ. Signs and symptoms in complex regional pain syndrome type I/reflex sympathetic dystrophy: judgment of the physician versus objective measurement. Clin J Pain. 1999 Sep;15(3):224-32.

location_facility:
Croix du Sud
University Hospital of Toulouse


title: Randomized Prospective Phase II Clinical Trial Using Post-Transplantation Cyclophosphamide for Prevention of GVHD in Haploidentical and HLA-9/10 Mismatched Unrelated Donors Hematopoietic Stem Cell Transplant

acronym: ALTERGREF

summary:
The primary objective of this study is to compare the 2-year progression free survival without acute graft versus host disease (GvHD) (aGvHD) grade III-IV or without moderate or severe chronic (cGVHD) after transplant from haploidentical hematopoietic stell cell transplant (HSCT) or from an unrelated Human Leukocyte Antigen (HLA)-9/10 mismatched unrelated donor (MMUD).

It will use a Phase II, multicenter, prospective, randomized clinical trial.

By setting a power of 80% and a type I error rate of 5% for a two-sided log-rank test (hypotheses tested: probability of event-free survival at 2 years 50% vs. 30 %), 92 patients need to be recruited in each arm, for a total of 184 patients.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Service Hématologie Clinique
Saint Louis hospital


title: Depression, Stress and Vulnerability Factors in Drug Resistant Focal Epilepsies

summary:
Psychiatric disturbances, notably depression, occur frequently as co-morbid conditions with epilepsy. A complex, probably bidirectional relationship between epilepsy and depression has been postulated. Both epilepsy and depression also interact with stressful life events, but only some patients develop these disorders after a stressful event, indicating the possibility of a "vulnerable" population. Animal and human studies have looked at the role of brain derived neurotrophic factor (BDNF) in this context. Low serum and/or CSF levels of BDNF are associated with higher incidence of depression, and thus indicate the vulnerable population.

Animal studies of BDNF have looked specifically at the relation between epilepsy and depression using a novel "double hit" design. After chronic stress exposure, measurement of BDNF levels allowed identification of 2 sub-groups: a vulnerable population and non-vulnerable population. A "second hit" of kainic acid induced status epilepticus (SE) was then applied to both the vulnerable and non-vulnerable populations. Only the vulnerable population exposed to SE developed a depression-like profile.

In a proof of concept approach we propose studying the relation between epilepsy, depression, anxiety and stressful life events, using serum BDNF levels in patients with pharmacoresistant epilepsy. Evaluation of epilepsy type and co-morbid psychiatric profile will be performed in 150 subjects. By comparing BDNF levels for different epilepsy subgroups to BDNF levels for healthy subjects and for depressed subjects without epilepsy, we hope to identify whether risk of co-morbid depression and/or anxiety in epilepsy may be predicted using BDNF levels. In addition, in a subgroup of 25 patients, we propose a pilot study in which cortisol and C-reactive protein will be measured in addition to BDNF.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille

intervention_type: Behavioral


title: Constitution of a Biological Cohort Following Bone Marrow Sampling From MDS or AML Patients and Age-matched Healthy Donors (COSMOS)

acronym: COSMOS

summary: It is of clinical significance to better characterize the intrinsic defects harbored by mesenchymal stromal cells (MSC) in Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) context, as compared to physiological conditions. Such research initiative aims to dissect the cross-talk between malignant hematopoietic stem cells (HSC) and their bone marrow (BM) partners in crime, further prospecting for innovative stromal-directed strategies for the treatment of Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML).

lead_sponsor: Institut de Cancérologie de la Loire

location_facility: Institut de Cancérologie Lucien Neuwirth


lead_sponsor: University Hospital, Montpellier

acronym: IRON KID

location_facility:
University Hospital of Angers
University Hospital of Montpellier

title: Comparison of the Rate of Preoperative Haemoglobin After Administration of Epoetin Alpha Associated With an Oral Medical Supplementation Versus Intravenous Before Surgery of Craniosynostosis at the Child

summary: Oral iron is commonly used in conjunction with EPO preoperatively for hemorrhagic surgeries in children and especially in the surgery of craniosynostosis. The bioavailability of oral iron is low and compliance with treatment is inconsistent. The aim of this study is to evaluate whether the use of ferric carboxymaltose by injection, which has a much better bioavailability, would make it possible to increase the preoperative hemoglobin level more effectively and thus reduce the risk of perioperative blood transfusion .


title: Impact of Early Low-Calorie Low-Protein Versus Standard-Calorie Standard-Protein Feeding on Outcomes of Ventilated Adults With Shock: a Randomised, Controlled, Multicentre, Open-label, Parallel-group Study (NUTRIREA-3)

summary: Among critically ill patients requiring mechanical ventilation and catecholamines for shock, nearly 40% to 50% die, and functional recovery is often delayed in survivors. International guidelines include early nutritional support (≤48 h after admission), 20-25 kcal/kg/d at the acute phase, and 1.2-2 g/kg/d protein. These targets are rarely achieved in patients with severe critically illnesses. Recent data challenge the wisdom of providing standard amounts of calories and protein during the acute phase of critical illness. Studies designed to improve enteral nutrition delivery showed no outcome benefits with higher intakes. Instead, adding parenteral nutrition to increase intakes was associated with longer ICU stays and more infectious complications. Studies suggest that higher protein intakes during the acute phase may be associated with greater muscle wasting and ICU-acquired weakness. The optimal calorie and protein supply at the acute phase of severe critical illness remains unknown. NUTRIREA-3 will be the first trial to compare standard calorie and protein feeding complying with guidelines to low-calorie low-protein feeding potentially associated with improved muscle preservation, translating into shorter mechanical ventilation and ICU-stay durations, lower ICU-acquired infection rates, lower mortality, and better long-term clinical outcomes. This multicentre, randomized, controlled, open trial will compare, in patients receiving mechanical ventilation and treated with vasoactive agent for shock two strategies for initiating nutritional support at the acute phase of ICU management (D0-D7): early calorie/protein restriction (6 kcal/kg/d/0.2-0.4 g/kg/d, Low group) or standard calorie/protein targets (25 kcal/kg/d/1.0-1.3 g/kg/d, Standard group). Patients in both groups will receive enteral or parenteral nutrition appropriate for their critical illness. Two alternative primary end-points will be evaluated: all-cause mortality by day 90 and time to discharge alive from the ICU. Second end-points will be calories and proteins delivered, nosocomial infections, gastro-intestinal complications, glucose control, liver dysfunctions, muscle function at the time of readiness for ICU discharge and quality of life at 3 months and 1 year after study inclusion.

ReferenceCitation: Reignier J, Le Gouge A, Lascarrou JB, Annane D, Argaud L, Hourmant Y, Asfar P, Badie J, Nay MA, Botoc NV, Brisard L, Bui HN, Chatellier D, Chauvelot L, Combes A, Cracco C, Darmon M, Das V, Debarre M, Delbove A, Devaquet J, Voicu S, Aissaoui-Balanant N, Dumont LM, Oziel J, Gontier O, Groyer S, Guidet B, Jaber S, Lambiotte F, Leroy C, Letocart P, Madeux B, Maizel J, Martinet O, Martino F, Mercier E, Mira JP, Nseir S, Picard W, Piton G, Plantefeve G, Quenot JP, Renault A, Guérin L, Richecoeur J, Rigaud JP, Schneider F, Silva D, Sirodot M, Souweine B, Reizine F, Tamion F, Terzi N, Thévenin D, Thiéry G, Thieulot-Rolin N, Timsit JF, Tinturier F, Tirot P, Vanderlinden T, Vinatier I, Vinsonneau C, Maugars D, Giraudeau B. Impact of early low-calorie low-protein versus standard-calorie standard-protein feeding on outcomes of ventilated adults with shock: design and conduct of a randomised, controlled, multicentre, open-label, parallel-group trial (NUTRIREA-3). BMJ Open. 2021 May 11;11(5):e045041. doi: 10.1136/bmjopen-2020-045041.

family: Reignier

full_name: Jean Reignier

given: Jean

family: Le Gouge

full_name: Amélie Le Gouge

given: Amélie

family: Lascarrou

full_name: Jean-Baptiste Lascarrou

given: Jean-Baptiste

family: Annane

full_name: Djillali Annane

given: Djillali

family: Argaud

full_name: Laurent Argaud

given: Laurent

family: Hourmant

full_name: Yannick Hourmant

given: Yannick

family: Asfar

full_name: Pierre Asfar

given: Pierre

family: Badie

full_name: Julio Badie

given: Julio

family: Nay

full_name: Mai-Anh Nay

given: Mai-Anh

family: Botoc

full_name: Nicolae-Vlad Botoc

given: Nicolae-Vlad

family: Brisard

full_name: Laurent Brisard

family: Bui

full_name: Hoang-Nam Bui

given: Hoang-Nam

family: Chatellier

full_name: Delphine Chatellier

family: Chauvelot

full_name: Louis Chauvelot

given: Louis

family: Combes

full_name: Alain Combes

given: Alain

family: Cracco

full_name: Christophe Cracco

given: Christophe

family: Darmon

full_name: Michael Darmon

given: Michael

family: Das

full_name: Vincent Das

given: Vincent

family: Debarre

full_name: Matthieu Debarre

given: Matthieu

family: Delbove

full_name: Agathe Delbove

given: Agathe

family: Devaquet

full_name: Jérôme Devaquet

given: Jérôme

family: Voicu

full_name: Sebastian Voicu

given: Sebastian

family: Aissaoui-Balanant

full_name: Nadia Aissaoui-Balanant

given: Nadia

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

location_facility: Hôpital de Hautepierre CHU de Strasbourg

location_facility: Centre Hospitalier Bretagne Atlantique - Vannes Auray


title: Characteristics of the Intestinal Microbiota in Patients With Cancer (Catalogue-Onco)

acronym: Catalogue-Onco

summary:
In order to understand how the intestinal microbiota plays a role in the effectiveness of an anti-cancer treatment by an immune control point inhibitor, this study aims to constitute a catalog of microbial genes of a patient with cancer. This catalog will help to characterize the intestinal microbiota of cancer patients and to be able to use this catalog as a reference tool for screening the microbiota of patients treated with immune control point inhibitors. To produce this catalog, five types of cancer were selected: non-small cell lung cancer, colorectal cancer, hepatocellular carcinoma, breast cancer and prostate cancer.

The metagenomic analysis of a group of five different types of cancers introduces a lot of heterogeneity which is favorable to the richness of a catalog. For non-small cell lung cancer treated with immune control point inhibitors, two stool collections will be performed per patient (one stool collection before setting up an immune control point inhibitor and one collection after one month of being inhibited Of immune control point) to assess the impact of the immune control point inhibitor on the microbiota (pilot study). For this study, two stool collection tubes containing different preservative solutions will be used (one RNAlater tube and one DMSO-EDTA tube for Dimethylsulfoxide-Ethylene diamine tetraacetic acid).

In parallel, we will also collect samples of serum and plasma to evaluate, in a second step, protein markers in circulating blood.

lead_sponsor: Centre Georges Francois Leclerc

location_facility:
Centre Georges-François Leclerc
Hopital Universitaire Paul Brousse


title: Evaluation of Efficacy of Two Therapeutic Strategies for Cervical Maturation Before Medical Termination: Mechanical Plus Medicinal Maturation vs Medicinal Maturation Alone

acronym: IMEGYN

summary: Reducing the time patients spend in the labor and delivery room saves money and reduces patient discomfort as well and reducing complications. We will compare two methods for inducing cervical maturation in order to shorten the time taken between administration of drugs and delivery.

primary_purpose: Other

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU de Montpellier
CHU Nimes


title: Analysis of Inhaled Corticoid Prescriptions in General Medicine

acronym: COMEGE

summary:
Chronic obstructive pulmonary disease (COPD) and asthma are frequent and disabling pathologies. The general practitioner is often at the front line vis-a-vis screening, diagnosis and treatment of these pathologies. There are currently many treatments available, in particular inhaled corticosteroids, and although the recommendations for management appear to be well codified in theory, the adaptation of drug therapy remains complex in general practice.

The prescription of inhaled corticosteroids, often initiated during a general medicine consultation, is not simple. The aim of this study is to analyze the relevance of the prescription of inhaled corticosteroids in primary care and to identify the criteria necessary for the prescription of inhaled corticosteroids available in general practice.

The main objective of our study is to evaluate the rate of consultations where all the elements required for guiding the prescription of an inhaled corticoid are available.

The secondary objectives are:

Identify other factors associated with decision-making
Identify the causes of inhaled corticosteroid stopping (de-prescription)

time_perspective: Cross-Sectional


title: Proteomic Analysis of Amniotic Fluid in the Case of Diaphragmatic Hernia: Search for Prognostic Expression Profiles

acronym: pro-CDH

summary:
Congenital diaphragmatic hernia (CDH) is a severe congenital malformation, related to a developmental defect of the diaphragm. The incidence of CDH is approximated at 1 in 3,000 live births. Although advances in surgery and neonatal intensive care have improved the prognosis, mortality remains high, around 30-50% related to severe lung hypoplasia and persistent pulmonary hypertension. Prenatal evaluation with observed/expected Lung over Head Ratio (o/e LHR), liver position and total lung volume measured by magnetic resonance, have been shown to correlate with neonatal mortality . However, the preponderant factor of persistent pulmonary hypertension remains difficult to predict prenatally. In patients with isolated diaphragmatic hernia (without associated malformations or karyotype abnormalities), prognosis is evaluated indirectly on pulmonary development from pulmonary volume measurements. Apart from the most caricatural cases with extremely good or very pejorative values, for a large proportion of fetuses with diaphragmatic dome hernia the prognosis remains uncertain.

The aim of the proposal is to investigate whether the analysis of the proteom of the amniotic fluid of the fetuses with CDH could give information of a prognostic character. The objective of the study is to identify, from the proteomic profile of the amniotic fluid of mothers whose fetus has CDH, prognostic markers candidates for death at 2 months of the infant. The first step is to carry out an exploratory and non-interventional study on a small sample (n = 10) of the target population. This is a preliminary step before considering, if the results are encouraging, a large-scale study from a biological collection to determine candidate proteins (new biomarkers) which relative expression levels could be used as surrogate marker of pulmonary hypoplasia.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
CHU de Dijon
CHU de Besançon


title: Recording Facial and Vocal Emotional Productions in Children With Autism as Part of the JEMImE Project

summary:
The purpose of the JEMImE project is to create a serious game to help children with Autism and Pervasive Developmental Disorder (PDD) develop facial and vocal emotions in context.

The objective of this study is to record facial and vocal emotional productions in children with autism and PDD in order to create an algorithm for the recognition of facial emotional expressions implemented in the serious game JEMImE.

lead_sponsor: Fondation Lenval

location_facility: Fondation Lenval Hôpitaux Pédiatriques de Nice CHU-LENVAL


title: Feasibility of DNA Analysis From Isolated Cardiomyocytes in the Molecular Diagnosis of Arrhythmogenic Right Ventricular Cardiomyopathy/Dysplasia

summary: The main objective of this study is to assess if it is possible, at the end of endocardial voltage mapping, to accurately collect intact cardiomyocytes and to isolate high quality DNA allowing molecular testing of selected genes involved in arrhythmogenic right ventricular cardiomyopathy/dysplasia.

location_facility: University Hospital Toulouse - Cardiology Department


title: Experience of Chronic (Non-malignant) Musculoskeletal Pain of French Adolescent and Young Adult: a Qualitative Research With Their Physicians and Non-medical Practitioners

acronym: DMS-AJA

summary:
The purpose of this study is to explore the perspectives of health professionals on chronic (non-malignant) musculoskeletal pain in adolescence and young adulthood. The prevalence of this pain symptom is rising for ten years, and most of the time the diagnosis is complex. Health professionals have to differentiate between the continuing activity of a somatic problem, some painful sequelae, a low threshold for the perception of pain, and psychological symptoms with somatic expression. Diagnosis in this case takes time, and is a matter of trained specialists. No protocol exists to assess the sub-clinical symptoms which will be used to help doing this complex task.

This qualitative study will elicit the perspectives of trained specialists on this diagnosis: how do they deal with these patients? What signs and symptoms helps them? The results will present their clinical experiences. The overall goal is to construct the first chronic musculoskeletal pain multidimensional scale that will help the practitioners with this complex diagnosis.

ReferenceCitation: Goodman JE, McGrath PJ. The epidemiology of pain in children and adolescents: a review. Pain. 1991 Sep;46(3):247-264. doi: 10.1016/0304-3959(91)90108-A. Review.

ReferenceCitation: De Inocencio J. Epidemiology of musculoskeletal pain in primary care. Arch Dis Child. 2004 May;89(5):431-4.

ReferenceCitation: Anthony KK, Schanberg LE. Pediatric pain syndromes and management of pain in children and adolescents with rheumatic disease. Pediatr Clin North Am. 2005 Apr;52(2):611-39, vii. Review.

ReferenceCitation: Petty RE, Southwood TR, Manners P, Baum J, Glass DN, Goldenberg J, He X, Maldonado-Cocco J, Orozco-Alcala J, Prieur AM, Suarez-Almazor ME, Woo P; International League of Associations for Rheumatology. International League of Associations for Rheumatology classification of juvenile idiopathic arthritis: second revision, Edmonton, 2001. J Rheumatol. 2004 Feb;31(2):390-2.

ReferenceCitation: Jaremko JL, Liu L, Winn NJ, Ellsworth JE, Lambert RG. Diagnostic utility of magnetic resonance imaging and radiography in juvenile spondyloarthritis: evaluation of the sacroiliac joints in controls and affected subjects. J Rheumatol. 2014 May;41(5):963-70. doi: 10.3899/jrheum.131064. Epub 2014 Mar 15.

ReferenceCitation: Bell DS, Bell KM, Cheney PR. Primary juvenile fibromyalgia syndrome and chronic fatigue syndrome in adolescents. Clin Infect Dis. 1994 Jan;18 Suppl 1:S21-3.

ReferenceCitation: McGhee JL, Burks FN, Sheckels JL, Jarvis JN. Identifying children with chronic arthritis based on chief complaints: absence of predictive value for musculoskeletal pain as an indicator of rheumatic disease in children. Pediatrics. 2002 Aug;110(2 Pt 1):354-9.

ReferenceCitation: Sherry DD, McGuire T, Mellins E, Salmonson K, Wallace CA, Nepom B. Psychosomatic musculoskeletal pain in childhood: clinical and psychological analyses of 100 children. Pediatrics. 1991 Dec;88(6):1093-9.

ReferenceCitation: Kashikar-Zuck S, Goldschneider KR, Powers SW, Vaught MH, Hershey AD. Depression and functional disability in chronic pediatric pain. Clin J Pain. 2001 Dec;17(4):341-9.

ReferenceCitation: - Lachal J, Speranza M, Schmitt A, Spodenkiewicz M, Falissard B, Moro MR, Revah-Levy A. Depression in adolescent from qualitative research to measurement. Adolescent Psychiatry 2012,2(4):296-308.

ReferenceCitation: - Smith J. Interpretative phenomenological analysis. In: Qualitative Psychology: A Practical Guide to Research Methods. 2e éd. Sage Publications Ltd; 2008.

ReferenceCitation: Taïeb O, Bricou O, Baubet T, Gaboulaud V, Gal B, Mouthon L, Dhote R, Guillevin L, Rose Moro M. Patients' beliefs about the causes of systemic lupus erythematosus. Rheumatology (Oxford). 2010 Mar;49(3):592-9. doi: 10.1093/rheumatology/kep430. Epub 2009 Dec 29.

ReferenceCitation: Smith JA, Michie S, Stephenson M, Quarrell O. Risk Perception and Decision-making Processes in Candidates for Genetic Testing for Huntington's Disease: An Interpretative Phenomenological Analysis. J Health Psychol. 2002 Mar;7(2):131-44. doi: 10.1177/1359105302007002398.

ReferenceCitation: Chapman E, Smith JA. Interpretative phenomenological analysis and the new genetics. J Health Psychol. 2002 Mar;7(2):125-30. doi: 10.1177/1359105302007002397.

ReferenceCitation: Lefèvre H, Loisel A, Meunier BB, Deslandre C, Lemoine N, Moro MR, Quartier P, Lachal J. Chronic idiopathic musculoskeletal pain in youth: a qualitative study. Pediatr Rheumatol Online J. 2019 Dec 27;17(1):86. doi: 10.1186/s12969-019-0389-3.

family: Lefèvre

full_name: Hervé Lefèvre

given: Hervé

family: Loisel

full_name: Alexandra Loisel

given: Alexandra

family: Meunier

full_name: Brigitte Bader Meunier

given: Brigitte Bader

family: Deslandre

full_name: Chantal Deslandre

given: Chantal

family: Lemoine

full_name: Noémie Lemoine

given: Noémie

family: Moro

full_name: Marie Rose Moro

given: Marie Rose

family: Quartier

full_name: Pierre Quartier

family: Lachal

full_name: Jonathan Lachal

given: Jonathan

journal_name: Pediatric Rheumatology

location_facility:
Cochin hospital
Necker Hospital


title: Evaluation of a Video-ludic Re-education of the Paretic Upper Limb in Chronic Hemipartic Patients Post Cerebral Vascular Accident

acronym: ERGOTACT

summary: The aim of this randomized controlled study with stroke patients is to demonstrate that a re-education with interactive table with instrumented objects delivering sensory feedback and serious game improve certain motor functions of the paretic upper limb than rehabilitation based on a standardized self-rehabilitation program.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805

location_facility:
Hopital Raymond Poincare
Nicolas ROCHE, Md PhD


title: Assessment of a New Fluorescence Imaging Technique Using Biopsies From Prostate Resection

acronym: Bio-Prost

summary:
In this study, we aim to evaluate the feasibility of anti-PSMA labelling to detect post-operative prostatic tissues by two ex vivo fluorescence techniques. We will evaluate the feasibility and detection of anti-PSMA labelling by:

/ the FEMTO-ST institute medical device,
/ the confocal microscope that will be used to measure fluorescence spectra of biological samples.

lead_sponsor: University Hospital, Grenoble

location_facility: Grenoble Alpes University Hospital - Urology department


title: Is Variation of Plasmatic Protein Concentration During Continuous Renal Replacement Therapy Predictive of Hypovolemia in Intensive Care Unit?

summary: The aim of the study is to analyze if blood protein concentration variation during continuous renal replacement therapy (CRRT) with fluid removal can predict a decrease of 15 % of cardiac index in intensive care unit (ICU) patients. Blood protein concentration, clinical data describing hemodynamic status (providing data from Pulsion medical system PiCCO2 ® monitoring), including preload dependency evaluation with passive leg raising, are collected at different times: before initiation of fluid removal, and after the first episode of hypotension or one hour after initiation of fluid removal.

ReferenceCitation: Lamia B, Ochagavia A, Monnet X, Chemla D, Richard C, Teboul JL. Echocardiographic prediction of volume responsiveness in critically ill patients with spontaneously breathing activity. Intensive Care Med. 2007 Jul;33(7):1125-1132. doi: 10.1007/s00134-007-0646-7. Epub 2007 May 17.

ReferenceCitation: Monnet X, Marik P, Teboul JL. Passive leg raising for predicting fluid responsiveness: a systematic review and meta-analysis. Intensive Care Med. 2016 Dec;42(12):1935-1947. doi: 10.1007/s00134-015-4134-1. Epub 2016 Jan 29. Review.

family: Monnet

full_name: Xavier Monnet

given: Xavier

family: Marik

full_name: Paul Marik

given: Paul

family: Teboul

full_name: Jean-Louis Teboul

given: Jean-Louis

journal_name: Intensive Care Medicine

ReferenceCitation: Monnet X, Cipriani F, Camous L, Sentenac P, Dres M, Krastinova E, Anguel N, Richard C, Teboul JL. The passive leg raising test to guide fluid removal in critically ill patients. Ann Intensive Care. 2016 Dec;6(1):46. doi: 10.1186/s13613-016-0149-1. Epub 2016 May 20.

family: Cipriani

full_name: Flora Cipriani

given: Flora

family: Camous

full_name: Laurent Camous

given: Laurent

family: Sentenac

full_name: Pierre Sentenac

given: Pierre

family: Dres

full_name: Martin Dres

given: Martin

family: Krastinova

full_name: Evguenia Krastinova

given: Evguenia

family: Anguel

full_name: Nadia Anguel

family: Richard

full_name: Christian Richard

given: Christian

journal_name: Annals of Intensive Care

ReferenceCitation: Bitker L, Bayle F, Yonis H, Gobert F, Leray V, Taponnier R, Debord S, Stoian-Cividjian A, Guérin C, Richard JC. Prevalence and risk factors of hypotension associated with preload-dependence during intermittent hemodialysis in critically ill patients. Crit Care. 2016 Feb 23;20:44. doi: 10.1186/s13054-016-1227-3.

lead_sponsor: Hopital Louis Pradel

location_facility:
Hôpital Cardiologique Louis Pradel
Matthias Jacquet-Lagreze


title: Assessment of the Evolution of Force and Endurance of Inspiratory Muscles in Intubated and Mechanically-ventilated ICU Patients With Difficult Weaning

acronym: EFES

summary:
Ventilator-induced diaphragmatic dysfunction appears to contribute to slow weaning from mechanical ventilation. Several trials of inspiratory muscle training to facilitate weaning in intensive care have been performed, with inconsistent results, utilizing different methods of IMT in different populations.

To perform the best IMT program, we need to know the physio-pathology of the diaphragm in difficult to wean patients.

This study proposes to discriminate the two main characteristics of the inspiratory muscles: strength and endurance.

By analyzing the evolution of strength and endurance during all the weaning period, we want to know which characteristic has the more deficiency to adapt in a second time an effective program of IMT.

lead_sponsor: University Hospital, Bordeaux

location_facility:
Hôpital Pellegrin
Hôpital Haut-Lévêque


title: Safety Acceptability and Benefits of Tracking Cardiac Pacemakers by Carelink Express

acronym: SAFECARE

summary: Follow-up strategy for patients implanted with a pacemaker.

primary_purpose: Device Feasibility

lead_sponsor: University Hospital, Brest

location_facility:
CH Lorient
CHRU Brest


title: The 4th Month Oral Consultation at Pregnant Women : Investigation Carried in Pregnant Women and Health Care Professionals of Nantes and Brest

summary: Epidemiological studies have suggested that maternal periodontitis affects the fetal-placental unit, with an increased risk of adverse pregnancy outcome. Indeed, it has been suggested that the direct or indirect action of parodontopathogenic bacteria induces an inflammatory cascade that leads to spontaneous premature labor. Also, non-treatment of caries and periodontal disease can lead to acute pain and stress. This may promote self-medication and the inappropriate use of analgesic medications, potentially harmful to the health of the fetus. As part of the prevention of complications of pregnancy associated with oral diseases, the National Agency for Accreditation and Evaluation in Health (ANAES) has set up a system that allows any pregnant woman to consult between the 4th and 7th month of pregnancy, an oral health professional to carry out a complete assessment and free care. This study aims at evaluating this device among pregnant women and healthcare professionals 4 years after its implementation. On the other hand, it will make it possible to look for a possible link between the realization of an oral prenatal follow-up and the outcome of the pregnancy.

lead_sponsor: Nantes University Hospital

location_facility:
Nantes University Hospital
Brest University Hospital


title: SPPLAASH Study : a Randomized Study Aiming at Evaluating the Incidence of Post Lumbar Puncture Headache (PLPH) With the Use of Atraumatic Needles in Hematology

acronym: SPPLAASH

summary: Lumbar punctures are implemented for the diagnosis of patients with hematologic symptoms as well as for the intrathecal chemotherapy injections. Post lumbar puncture headache is a common complication for patients and is characterized by the occurrence of a headache with an orthostatic component, with additional symptoms such as nausea. Some studies in neurology, anesthesia and gynecology have previously shown a decreased incidence for post lumbar puncture headache while using atraumatic needles as compared to standard needles. In this context, it is necessary to better document the incidence of post lumbar puncture headache with the use of atraumatic needles in hematologic patients.


title: Prospective, Randomized, Single-blind, Multinational, Long-term Study for the Evaluation of the Clinical Outcome, Oxidation Profile and Wear Analysis of Medium Cross-linked Polyethylene With and Without Vitamin E for Total Knee Arthroplasty

acronym: VIKEP

summary: Prospective, randomized, single-blind, multinational, long-term study for the evaluation of the clinical outcome, oxidation profile and wear analysis of medium cross-linked Polyethylene with and without Vitamin E for total knee arthroplasty

lead_sponsor: Aesculap AG

location_country: Germany France

location_facility: Universitätsklinikum Rostock, Klinik für Orthopädie


title: Positron Emission Tomography Imaging of Brain Reorganisation of the Central Auditory Cortex in Asymetrical Profound Deaf Patient With a Cochlear Implantation

acronym: UniTEP

summary: Our main objective is to study how the extent of reorganization of the central auditory system is related to the binaural integration in cochlear implanted subjects with asymmetric hearing loss. Subjects with asymmetric hearing loss treated with a cochlear implant and a control group of normal hearing subjects will perform two tests for binaural integration (speech recognition in noise and spatial localization) and two tasks of non-linguistic sounds perception.

ReferenceCitation: Deggouj N, Gersdorff M, Garin P, Castelein S, Gérard JM. Today's indications for cochlear implantation. B-ENT. 2007;3(1):9-14. Review.

ReferenceCitation: Devocht EM, Dees G, Arts RA, Smits JJ, George EL, van Hoof M, Stokroos RJ. Revisiting Place-Pitch Match in CI Recipients Using 3D Imaging Analysis. Ann Otol Rhinol Laryngol. 2016 May;125(5):378-84. doi: 10.1177/0003489415616130. Epub 2015 Dec 1.

ReferenceCitation: Shannon RV, Zeng FG, Kamath V, Wygonski J, Ekelid M. Speech recognition with primarily temporal cues. Science. 1995 Oct 13;270(5234):303-4.

ReferenceCitation: Fu QJ, Shannon RV, Wang X. Effects of noise and spectral resolution on vowel and consonant recognition: acoustic and electric hearing. J Acoust Soc Am. 1998 Dec;104(6):3586-96.

ReferenceCitation: Munson B, Nelson PB. Phonetic identification in quiet and in noise by listeners with cochlear implants. J Acoust Soc Am. 2005 Oct;118(4):2607-17.

ReferenceCitation: Rouger J, Lagleyre S, Fraysse B, Deneve S, Deguine O, Barone P. Evidence that cochlear-implanted deaf patients are better multisensory integrators. Proc Natl Acad Sci U S A. 2007 Apr 24;104(17):7295-300. Epub 2007 Apr 2.

ReferenceCitation: Rouger J, Fraysse B, Deguine O, Barone P. McGurk effects in cochlear-implanted deaf subjects. Brain Res. 2008 Jan 10;1188:87-99. Epub 2007 Oct 26.

ReferenceCitation: Marx M, James C, Foxton J, Capber A, Fraysse B, Barone P, Deguine O. Speech prosody perception in cochlear implant users with and without residual hearing. Ear Hear. 2015 Mar-Apr;36(2):239-48. doi: 10.1097/AUD.0000000000000105.

ReferenceCitation: Strelnikov K, Rouger J, Demonet JF, Lagleyre S, Fraysse B, Deguine O, Barone P. Does brain activity at rest reflect adaptive strategies? Evidence from speech processing after cochlear implantation. Cereb Cortex. 2010 May;20(5):1217-22. doi: 10.1093/cercor/bhp183. Epub 2009 Oct 5.

ReferenceCitation: Strelnikov K, Rouger J, Lagleyre S, Fraysse B, Démonet JF, Déguine O, Barone P. Increased audiovisual integration in cochlear-implanted deaf patients: independent components analysis of longitudinal positron emission tomography data. Eur J Neurosci. 2015 Mar;41(5):677-85. doi: 10.1111/ejn.12827.

ReferenceCitation: Strelnikov K, Rouger J, Demonet JF, Lagleyre S, Fraysse B, Deguine O, Barone P. Visual activity predicts auditory recovery from deafness after adult cochlear implantation. Brain. 2013 Dec;136(Pt 12):3682-95. doi: 10.1093/brain/awt274. Epub 2013 Oct 17.

ReferenceCitation: Rouger J, Lagleyre S, Démonet JF, Fraysse B, Deguine O, Barone P. Evolution of crossmodal reorganization of the voice area in cochlear-implanted deaf patients. Hum Brain Mapp. 2012 Aug;33(8):1929-40. doi: 10.1002/hbm.21331. Epub 2011 May 6.

ReferenceCitation: Giraud AL, Truy E, Frackowiak RS, Grégoire MC, Pujol JF, Collet L. Differential recruitment of the speech processing system in healthy subjects and rehabilitated cochlear implant patients. Brain. 2000 Jul;123 ( Pt 7):1391-402.

ReferenceCitation: Giraud AL, Price CJ, Graham JM, Truy E, Frackowiak RS. Cross-modal plasticity underpins language recovery after cochlear implantation. Neuron. 2001 Jun;30(3):657-63.

ReferenceCitation: Vannson N, James C, Fraysse B, Strelnikov K, Barone P, Deguine O, Marx M. Quality of life and auditory performance in adults with asymmetric hearing loss. Audiol Neurootol. 2015;20 Suppl 1:38-43. doi: 10.1159/000380746. Epub 2015 May 19.

ReferenceCitation: Scheffler K, Bilecen D, Schmid N, Tschopp K, Seelig J. Auditory cortical responses in hearing subjects and unilateral deaf patients as detected by functional magnetic resonance imaging. Cereb Cortex. 1998 Mar;8(2):156-63.

ReferenceCitation: Ponton CW, Vasama JP, Tremblay K, Khosla D, Kwong B, Don M. Plasticity in the adult human central auditory system: evidence from late-onset profound unilateral deafness. Hear Res. 2001 Apr;154(1-2):32-44.

ReferenceCitation: Massida Z, Belin P, James C, Rouger J, Fraysse B, Barone P, Deguine O. Voice discrimination in cochlear-implanted deaf subjects. Hear Res. 2011 May;275(1-2):120-9. doi: 10.1016/j.heares.2010.12.010. Epub 2010 Dec 16.

ReferenceCitation: Guerreiro MJ, Erfort MV, Henssler J, Putzar L, Röder B. Increased visual cortical thickness in sight-recovery individuals. Hum Brain Mapp. 2015 Dec;36(12):5265-74. doi: 10.1002/hbm.23009. Epub 2015 Sep 29.

ReferenceCitation: Collett E, Marx M, Gaillard P, Roby B, Fraysse B, Deguine O, Barone P. Categorization of common sounds by cochlear implanted and normal hearing adults. Hear Res. 2016 May;335:207-219. doi: 10.1016/j.heares.2016.03.007. Epub 2016 Apr 2.

ReferenceCitation: Strelnikov K, Rouger J, Lagleyre S, Fraysse B, Deguine O, Barone P. Improvement in speech-reading ability by auditory training: Evidence from gender differences in normally hearing, deaf and cochlear implanted subjects. Neuropsychologia. 2009 Mar;47(4):972-9. doi: 10.1016/j.neuropsychologia.2008.10.017. Epub 2008 Oct 30.

lead_sponsor: University Hospital, Toulouse

location_facility:
CHU de Toulouse - Hôpital Purpan
CERCO


title: Observational, Longitudinal, Prospective, French, Multicentre Study Conducted on Adult and Paediatric Patients Treated With Micafungin in Prophylaxis and Followed Over a 3 Months' Period in Routine Medical Practice

acronym: OLYMPE

summary: The purpose of this observational study is to describe the actual conditions of prescription of micafungin in antifungal prophylaxis in French haematological and onco-haematological units. The efficacy and the safety outcomes will be described.

ipd_sharing_description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

lead_sponsor: Astellas Pharma S.A.S.