title: Development and Validation of a Specific Scale of Life'Quality for Children With Low-flow Vascular Malformations Aged 11 to 15 Years-old.

acronym: MVFL

summary:
The low-flow malformations include venous and lymphatic malformations. The malformation often affects the skin and can extend deep to the muscles and bone, as well as to deep organs. Children with low-flow vascular malformation and their family have difficulty living with their illness and have an impact on their life quality.

In this context, the aim of the study is to develope life quality test for the children between 11 to 15 years old.

lead_sponsor: University Hospital, Toulouse

location_facility: UHChambray UHNantes UHBordeaux

intervention_type: Behavioral


title: Effects on the Pain of an Infiltration by Acid Hyaluronic Association and Corticoids Versus Only Corticoids in the Rhizarthrosis.

acronym: RHIZ'ART

summary:
The rhizarthrosis, or the degenerative osteoarthritis of the trapezo-metacarpal joint, is a frequent degenerative osteoarthritis.

The treatment associates not pharmacological measures, such as resting relative of the joint, the orthosis of rest, glazing and pharmacological measures such analgesic, anti-inflammatory not steroidal per bones or premises, even infiltrations cortisone or by hyaluronic acid.

No study has, for the moment, tested the interest of the combination of cortisone and hyaluronic acid in rhizarthrosis. In view of the current publications, we propose to carry out a study on two arms, with corticosteroids in reference arm; the experimental arm is the combination of hyaluronic acid and cortisone.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Cormier G, Le Goff B, Denis A, Varin S, Auzanneau L, Dimet J, Le Thuaut A. Corticosteroids injections versus corticosteroids with hyaluronic acid injections in rhizarthrosis: the randomised multicentre RHIZ'ART trial study protocol. BMJ Open. 2019 Jan 9;9(1):e022553. doi: 10.1136/bmjopen-2018-022553.

family: Cormier

full_name: Grégoire Cormier

given: Grégoire

sequence: first

family: Le Goff

full_name: Benoit Le Goff

given: Benoit

sequence: additional

family: Denis

full_name: Amélie Denis

given: Amélie

family: Varin

full_name: Stéphane Varin

given: Stéphane

family: Auzanneau

full_name: Lucie Auzanneau

given: Lucie

family: Dimet

full_name: Jérôme Dimet

given: Jérôme

family: Le Thuaut

full_name: Aurélie Le Thuaut

given: Aurélie

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

title: Corticosteroids injections versus corticosteroids with hyaluronic acid injections in rhizarthrosis: the randomised multicentre RHIZ’ART trial study protocol

ipd_sharing: No

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility:
CHU Nantes
CH Le Mans
CHD Vendée

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Ongoing


title: Therapeutic Drug Monitoring of Kinase Inhibitors and Study of Circulating Tumor DNA in Patients With Mutated BRAF Metastatic Cutaneous Melanoma and Treated With Anti-BRAF and Anti-MEK Kinase Inhibitors

acronym: OPTIMEL

summary: BRAF V600-mutant metastatic melanoma are commonly treated using a combination of anti-BRAF and anti-MEK tyrosine kinase inhibitors (TKIs). The OPTIMEL trial aims to study the interest of therapeutic drug monitoring (TDM) of TKIs and circulating tumor DNA (ctDNA) detected in plasma of patients with metastatic melanoma for disease monitoring. 35 patients with metastatic melanoma and treated with dabrafenib and trametinib will be enrolled in this trial. Blood samples will be collected for the determination of TKIs concentration and ctDNA detection.

status: Recruiting

primary_purpose: Other

enrollment_type: Anticipated

lead_sponsor: Institut de Cancérologie de Lorraine

location_facility: Institut de Cancérologie de Lorraine (ICL)

intervention_type: Other

lead_sponsor_type: industriel


title: Reference Curve on Bone Mineral Density in Men

summary: In men, the hope of lower life, the absence of equivalent of menopause and the existence of a higher peak bone mass are the three factors that explain the lower incidence of osteoporosis in men.

ReferenceType: background

ReferenceCitation: Abrahamsen B, Hansen TB, Jensen LB, Hermann AP, Eiken P. Site of osteodensitometry in perimenopausal women: correlation and limits of agreement between anatomic regions. J Bone Miner Res. 1997 Sep;12(9):1471-9.

ReferenceCitation: Smotherman MS, Narins PM. Effect of temperature on electrical resonance in leopard frog saccular hair cells. J Neurophysiol. 1998 Jan;79(1):312-21.

ReferenceCitation: Baumgartner RN. Body composition in elderly persons: a critical review of needs and methods. Prog Food Nutr Sci. 1993 Jul-Sep;17(3):223-60. Review.

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility:
Hopital Lariboisiere
CHU de Saint Etienne
CHU Amiens

intervention_type: Diagnostic Test


title: TOXODIAG: New Diagnostic Approach for Congenital Toxoplasmosis

acronym: TOXODIAG

summary:
Caused by Toxoplasma gondii, toxoplasmosis is mostly asymptomatic except in immunocompromised individuals and infants infected in utero. Congenital toxoplasmosis (CT) results from the transplacental passage of the parasite, which occurs in 30% of cases of primary infection during pregnancy. Neonatal biological diagnosis of toxoplasmosis is essential in the case of (i) suggestive clinical signs in the newborn with no information on the serological status of the mother, (ii) seroconversion diagnosed during pregnancy, (iii) not or poorly followed pregnancy, and (iiii) for enhanced effectiveness of treatments administered as soon as possible to the newborn. Given the limitations of current diagnostic tests, the characterization of specific immunoglobulin (Ig)G neo-synthesized by the newborn would be of great help for an early diagnosis of CT.

The main objective of the TOXODIAG project is to validate and evaluate the ELISPOT (Enzyme-Linked Immunosorbent SPOT assay) method for detecting, in the newborn, B lymphocytes (LyB) sensitized in utero to produce T. gondii specific immunoglobulins (Ig) following a primary infection of the mother during the pregnancy. More precisely, the detection and quantification of LyB secreting IgG and IgM specific for T. gondii using the ELISPOT method will be applied i) to mononuclear cells of women in seroconversion following a toxoplasmic primo-infection during pregnancy and ii) to cord blood mononuclear cells of newborns suspected of CT, in comparison to positive and negative infection controls.

To reach this goal, TOXODIAG is a diagnostic, multicentric, prospective, non-randomized, comparative and controlled study. It will be performed in 3 parallel groups of pregnant women performing prenatal follow-up and giving birth in the maternity wards of 3 hospitals of the AP-HP (Louis MOURIER, Bichat-Claude Bernard and Cochin) which ensure mother/child follow-up and biological sampling, with great gynecology and obstetrics expertise. Sixty women will be selected and included into 3 groups according to toxoplasmic seroconversion during pregnancy (n=30), positive (n=15) or negative (n=15) toxoplasma serology. The necessary biological material will consist in additional blood tubes which will be taken at the same time as those performed for the usual pregnancy follow-up examinations and will correspond to maternal peripheral blood at inclusion, seroconversion and delivery as well as cord blood.

status: Unknown status

design_allocation: Non-Randomized

primary_purpose: Diagnostic

ipd_sharing: Undecided

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Hopital Bichat
Hopital Cochin
Hopital Louis Mourier

intervention_type: Biological

status_simplified: Unknown


title: Retrospective Analysis of the Determinants of Air Leakage in a Population of Obstructive Sleep Apnea Syndrome Treated With Continuous Positive Airway Pressure

summary:
The software embedded in recent continuous positive pressure devices enables the analysis of the level of leakage that occurs during treatment around the mask or from the mouth. However, there is no clear threshold defining when it would be appropriate to implement means for correcting these leaks. In addition, the calculation methods used to detect/measure leaks and the terminology used vary according to the manufacturers of continuous pressure devices, which also complicates the clinical interpretation of the leakage reports provided by the various devices.

In daily practice, when a patient complains of unintentional leakage, technicians adjust the mask, replace the nasal-mask by an oro-nasal mask or install a chinstrap. Nevertheless, those strategies are not always effective in reducing leakage or patient's complaints. A better understanding of the mechanisms beyond leak appearance for a given patient could lead to individualised leak-treatment solutions. Pressure level, mandibular behaviour, respiratory effort, sleep position or sleep stages may contribute to leak emergence.

A recent exploratory study has proposed a genuine analysis method of determining factors of unintentional-leaks using polysomnographic recordings in OSA patients treated with automatic Continuous Positive Airway Pressure (auto-CPAP). Based on the same methodology, the NOMICS company (Liège, Belgium) has developed a polygraphic device (Brizzy®) recording unintentional leakage during auto-CPAP treatment and providing an etiological analysis of unintentional-leaks via a software named APIOS.

Due to the innovative nature of the analysis, it appears necessary to validate it onto a population of OSA patients treated with auto-CPAP. Also, to our knowledge, there is no descriptive data of the distribution of the determinants of unintentional leaks in such a population. From this perspective, the investigators aim to retrospectively analyse some polygraphic recordings that have been performed with the Brizzy® on OSA patients treated with auto-CPAP.

The primary objective of this study is to identify and describe the determinants of unintentional leaks for a population of patients with OSA and treated with an auto-CPAP device

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

ReferenceType: result

ReferenceCitation: Lebret M, Arnol N, Martinot JB, Lambert L, Tamisier R, Pepin JL, Borel JC. Determinants of Unintentional Leaks During CPAP Treatment in OSA. Chest. 2018 Apr;153(4):834-842. doi: 10.1016/j.chest.2017.08.017. Epub 2017 Aug 26.

family: Lebret

full_name: Marius Lebret

given: Marius

family: Arnol

full_name: Nathalie Arnol

given: Nathalie

family: Martinot

full_name: Jean-Benoît Martinot

given: Jean-Benoît

family: Lambert

full_name: Loïc Lambert

given: Loïc

family: Tamisier

full_name: Renaud Tamisier

given: Renaud

family: Pepin

full_name: Jean-Louis Pepin

given: Jean-Louis

family: Borel

full_name: Jean-Christian Borel

given: Jean-Christian

journal_name: Chest

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Lebret M, Jaffuel D, Suehs CM, Mallet JP, Lambert L, Rotty MC, Pépin JL, Matzner-Lober E, Molinari N, Borel JC. Feasibility of Type 3 Polygraphy for Evaluating Leak Determinants in CPAP-Treated OSA Patients: A Step Toward Personalized Leak Management. Chest. 2020 Nov;158(5):2165-2171. doi: 10.1016/j.chest.2020.05.593. Epub 2020 Jun 13.

family: Jaffuel

full_name: Dany Jaffuel

given: Dany

family: Suehs

full_name: Carey M. Suehs

given: Carey M.

family: Mallet

full_name: Jean-Pierre Mallet

given: Jean-Pierre

family: Rotty

full_name: Marie-Caroline Rotty

given: Marie-Caroline

family: Pépin

full_name: Jean-Louis Pépin

family: Matzner-Lober

full_name: Eric Matzner-Lober

given: Eric

family: Molinari

full_name: Nicolas Molinari

given: Nicolas

lead_sponsor: University Hospital, Montpellier

location_facility:
Polyclinic Saint-Privat
University Hospital of Grenoble
Hôpital Arnaud de Villeneuve

intervention_type: Device

status_simplified: Completed


title: A Prospective RegistrY of Cardiac Echographic Loops

acronym: ARYEL

summary:
CARDIAWAVE, a French start-up founded in 2014, aims to develop a new non-invasive therapy to treat patients suffering from Aortic Valve Stenosis (AS) who are not candidates to validated treatment of AS, i.e. TAVI (Transcatheter Aortic Valve Implantation) or SAVR (Surgical Aortic Valve Replacement). This therapy consists in focusing ultrasound on aortic valve transthoracically and use high energy to soften calcification from the target valve. In order to do so, we develop a device able to deliver high energy ultrasounds to a targeted valve thanks to the synchronization of patient hearts live imaging and therapy in real time.

Live imaging will use an algorithm to realize 'valve tracking': an automatic detection of aortic valve position and shape as fast as image acquisition time. In order to develop and validate this 'valve tracking' algorithm, CARDIAWAVE requires cardiac echographic loops of patients with aortic valve calcification, with 30 seconds or 60 seconds recording.

The objective of the present study is to develop and validate the 'valve tracking' processing algorithm of CARDIAWAVE.

ARYEL is a prospective, multicenter, non-interventional study.

time_perspective: Prospective

lead_sponsor: Cardiawave SA

location_facility:
Hôpital Charles Nicolle
CHU de Caen
Hôpital Européen Georges Pompidou


title: Innovative Strategies for Perinatal Infectious Risk Reduction

acronym: InSPIRe

summary: The purpose of the protocol is to validate a novel point of care multiplex system to detect and characterize microorganisms responsible for neonatal sepsis, as well as biomarkers of infection, from a simple vaginal sample, in order to improve the prevention of perinatal bacterial infections.

primary_purpose: Screening

ReferenceCitation: Joubrel C, Tazi A, Six A, Dmytruk N, Touak G, Bidet P, Raymond J, Trieu Cuot P, Fouet A, Kernéis S, Poyart C. Group B streptococcus neonatal invasive infections, France 2007-2012. Clin Microbiol Infect. 2015 Oct;21(10):910-6. doi: 10.1016/j.cmi.2015.05.039. Epub 2015 Jun 5.

ReferenceCitation: Dussaux C, Senat MV, Bouchghoul H, Benachi A, Mandelbrot L, Kayem G. Preterm premature rupture of membranes: is home care acceptable? J Matern Fetal Neonatal Med. 2018 Sep;31(17):2284-2292. doi: 10.1080/14767058.2017.1341482. Epub 2017 Jul 6.

ReferenceCitation: Kayem G, Batteux F, Girard N, Schmitz T, Willaime M, Maillard F, Jarreau PH, Goffinet F. Predictive value of vaginal IL-6 and TNFα bedside tests repeated until delivery for the prediction of maternal-fetal infection in cases of premature rupture of membranes. Eur J Obstet Gynecol Reprod Biol. 2017 Apr;211:8-14. doi: 10.1016/j.ejogrb.2017.01.013. Epub 2017 Jan 12.

ReferenceCitation: Lorthe E, Ancel PY, Torchin H, Kaminski M, Langer B, Subtil D, Sentilhes L, Arnaud C, Carbonne B, Debillon T, Delorme P, D'Ercole C, Dreyfus M, Lebeaux C, Galimard JE, Vayssiere C, Winer N, L'Helias LF, Goffinet F, Kayem G. Impact of Latency Duration on the Prognosis of Preterm Infants after Preterm Premature Rupture of Membranes at 24 to 32 Weeks' Gestation: A National Population-Based Cohort Study. J Pediatr. 2017 Mar;182:47-52.e2. doi: 10.1016/j.jpeds.2016.11.074. Epub 2017 Jan 9.

ReferenceCitation: Delorme P, Goffinet F, Ancel PY, Foix-L'Hélias L, Langer B, Lebeaux C, Marchand LM, Zeitlin J, Ego A, Arnaud C, Vayssiere C, Lorthe E, Durrmeyer X, Sentilhes L, Subtil D, Debillon T, Winer N, Kaminski M, D'Ercole C, Dreyfus M, Carbonne B, Kayem G. Cause of Preterm Birth as a Prognostic Factor for Mortality. Obstet Gynecol. 2016 Jan;127(1):40-48. doi: 10.1097/AOG.0000000000001179.

ReferenceCitation: Plainvert C, El Alaoui F, Tazi A, Joubrel C, Anselem O, Ballon M, Frigo A, Branger C, Mandelbrot L, Goffinet F, Poyart C. Intrapartum group B Streptococcus screening in the labor ward by Xpert® GBS real-time PCR. Eur J Clin Microbiol Infect Dis. 2018 Feb;37(2):265-270. doi: 10.1007/s10096-017-3125-2. Epub 2017 Oct 29.

ReferenceCitation: Six A, Firon A, Plainvert C, Caplain C, Bouaboud A, Touak G, Dmytruk N, Longo M, Letourneur F, Fouet A, Trieu-Cuot P, Poyart C. Molecular Characterization of Nonhemolytic and Nonpigmented Group B Streptococci Responsible for Human Invasive Infections. J Clin Microbiol. 2016 Jan;54(1):75-82. doi: 10.1128/JCM.02177-15. Epub 2015 Oct 21. Erratum in: J Clin Microbiol. 2016 Jul;54(7):1932.

location_facility:
Hopital Bichat
Hôpital Cochin
Hopital Louis Mourier


title: SArcopenia, Mobility, PHYsical Activity and Post-operative Risk of Bladder Carcinoma in the Elderly

acronym: SAMPHYR

summary:
Sarcopenia is associated with lower prognosis in solid tumors, but this has not been studied in bladder carcinoma requiring cystectomy.

According to EWGSOP recommendations, the diagnosis of sarcopenia is based on walking speed, grip strength and muscle mass. These three elements can easily be measured (specially muscle mass measurement by bioimpedencemetry or tomodensitometry).

This cohort study will collect clinical complementary elements to better understand the associated factors present with sarcopenia, in order to prepare an interventional preoperative physical reconditioning study.

The mobility measurement will be carried out by the QAPPA questionnaire (validated in French in the elderly) and the quantitative measurement of activity and rest hours during a week by a wrist actimeter.

Standardized geriatric data will also be collected: ADL, IADL for autonomy, MMSE for cognitive status, nutritional status (% weight loss, BMI), pain, GDS15 for depression screening, updated Charlson Comorbidity Index to identify polypathology and The STOPP tool for potentially inappropriate medication.

Post-operative morbidity mortality at 30 days will be evaluated according to Clavien-Dindo classification. Investigators will also evaluate 6 months geriatric complications : falls, loss of autonomy and decreased mobility and physical activity, cognitive degradation, undernutrition, institutionalization

ReferenceCitation: Audisio RA, Bozzetti F, Gennari R, Jaklitsch MT, Koperna T, Longo WE, Wiggers T, Zbar AP. The surgical management of elderly cancer patients; recommendations of the SIOG surgical task force. Eur J Cancer. 2004 May;40(7):926-38.

ReferenceCitation: Huisman MG, van Leeuwen BL, Ugolini G, Montroni I, Spiliotis J, Stabilini C, de'Liguori Carino N, Farinella E, de Bock GH, Audisio RA. "Timed Up & Go": a screening tool for predicting 30-day morbidity in onco-geriatric surgical patients? A multicenter cohort study. PLoS One. 2014 Jan 24;9(1):e86863. doi: 10.1371/journal.pone.0086863. eCollection 2014. Erratum in: PLoS One. 2014;9(7):e103907. de'Liguori Carino, Nicola [corrected to Carino, Nicola de'Liguori]. PLoS One. 2016;11(1):e0147993.

family: Huisman

full_name: Monique G. Huisman

given: Monique G.

family: van Leeuwen

full_name: Barbara L. van Leeuwen

given: Barbara L.

family: Ugolini

full_name: Giampaolo Ugolini

given: Giampaolo

family: Montroni

full_name: Isacco Montroni

given: Isacco

family: Spiliotis

full_name: John Spiliotis

given: John

family: Stabilini

full_name: Cesare Stabilini

given: Cesare

family: de’Liguori Carino

full_name: Nicola de’Liguori Carino

given: Nicola

family: Farinella

full_name: Eriberto Farinella

given: Eriberto

family: de Bock

full_name: Geertruida H. de Bock

given: Geertruida H.

family: Audisio

full_name: Riccardo A. Audisio

given: Riccardo A.

bso_classification: Biology (fond.)

currency_apc_doaj: USD

journal_name: PLoS ONE

license: cc-by

license_normalized: cc-by

endpoint_id: fhisxppmrqpajgzqkvft

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

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

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

title: "Timed Up & Go": A Screening Tool for Predicting 30-Day Morbidity in Onco-Geriatric Surgical Patients? A Multicenter Cohort Study

ReferenceCitation: Shachar SS, Williams GR, Muss HB, Nishijima TF. Prognostic value of sarcopenia in adults with solid tumours: A meta-analysis and systematic review. Eur J Cancer. 2016 Apr;57:58-67. doi: 10.1016/j.ejca.2015.12.030. Epub 2016 Feb 13. Review.

family: Shachar

full_name: Shlomit Strulov Shachar

given: Shlomit Strulov

family: Williams

ReferenceCitation: Psutka SP, Carrasco A, Schmit GD, Moynagh MR, Boorjian SA, Frank I, Stewart SB, Thapa P, Tarrell RF, Cheville JC, Tollefson MK. Sarcopenia in patients with bladder cancer undergoing radical cystectomy: impact on cancer-specific and all-cause mortality. Cancer. 2014 Sep 15;120(18):2910-8. doi: 10.1002/cncr.28798. Epub 2014 May 19.

name: Department of Urology; Mayo Clinic; Rochester Minnesota

name: Department of Radiology; Mayo Clinic; Rochester Minnesota

name: Department of Health Services Research; Mayo Clinic; Rochester Minnesota

name: Department of Pathology; Mayo Clinic; Rochester Minnesota

title: Sarcopenia in patients with bladder cancer undergoing radical cystectomy: Impact on cancer-specific and all-cause mortality

ReferenceCitation: Smith AB, Deal AM, Yu H, Boyd B, Matthews J, Wallen EM, Pruthi RS, Woods ME, Muss H, Nielsen ME. Sarcopenia as a predictor of complications and survival following radical cystectomy. J Urol. 2014 Jun;191(6):1714-20. doi: 10.1016/j.juro.2013.12.047. Epub 2014 Jan 11.

name: Multidisciplinary Genitourinary Oncology, Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina

name: Department of Urology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina

name: Biostatistics and Clinical Data Management Core, Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina

name: Department of Radiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina

name: Geriatric Oncology, Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina

name: Department of Hematology/Oncology, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina

name: Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Sarcopenia as a Predictor of Complications and Survival Following Radical Cystectomy


title: A Phase II Trial Aiming to Evaluate the Clinical Interest of ABEMACICLIB Monotherapy in Patients With Locally Advanced/Metastatic Head and Neck Cancer After Failure of Platinum and Cetuximab or Anti-EGFR-based Therapy and Harboring an Homozygous Deletion of CDKN2A, and/or an Amplification of CCND1 and/or of CDK6

acronym: ABORL

summary:
This trial is an open-label, single arm, Phase II study using an A'Hern single stage design.

The molecular prescreening step will allow to defined HPV tumor status as well as molecular status CDKN2A, CCND1 and CDK6. Following this centralized molecular screening, only patients with HPV negative status and with tumor harboring CDKN2A homozygous deletion and/or CCND1 amplification and/or CDK6 amplification could initiate abemaciclib at time of documented radiological progression. Patients will be treated with ABEMACICLIB, 400 mg/day with 2 doses of 200 mg 12 hour apart (QH12). A cycle is defined as an interval of 28 days. For each 28-day cycle, a total of 56 doses of study drug will be dispensed.

ReferenceCitation: Vokes EE, Weichselbaum RR, Lippman SM, Hong WK. Head and neck cancer. N Engl J Med. 1993 Jan 21;328(3):184-94. Review.

ReferenceCitation: Molin Y, Fayette J. Current chemotherapies for recurrent/metastatic head and neck cancer. Anticancer Drugs. 2011 Aug;22(7):621-5. doi: 10.1097/CAD.0b013e3283421f7c. Review.

ReferenceCitation: Vermorken JB, Trigo J, Hitt R, Koralewski P, Diaz-Rubio E, Rolland F, Knecht R, Amellal N, Schueler A, Baselga J. Open-label, uncontrolled, multicenter phase II study to evaluate the efficacy and toxicity of cetuximab as a single agent in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck who failed to respond to platinum-based therapy. J Clin Oncol. 2007 Jun 1;25(16):2171-7.

ReferenceCitation: Vermorken JB, Mesia R, Rivera F, Remenar E, Kawecki A, Rottey S, Erfan J, Zabolotnyy D, Kienzer HR, Cupissol D, Peyrade F, Benasso M, Vynnychenko I, De Raucourt D, Bokemeyer C, Schueler A, Amellal N, Hitt R. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med. 2008 Sep 11;359(11):1116-27. doi: 10.1056/NEJMoa0802656.

family: Vermorken

full_name: Jan B. Vermorken

given: Jan B.

family: Mesia

full_name: Ricard Mesia

given: Ricard

family: Rivera

full_name: Fernando Rivera

given: Fernando

family: Remenar

full_name: Eva Remenar

given: Eva

family: Kawecki

full_name: Andrzej Kawecki

given: Andrzej

family: Rottey

full_name: Sylvie Rottey

given: Sylvie

family: Erfan

full_name: Jozsef Erfan

given: Jozsef

family: Zabolotnyy

full_name: Dmytro Zabolotnyy

given: Dmytro

family: Kienzer

full_name: Heinz-Roland Kienzer

given: Heinz-Roland

family: Cupissol

full_name: Didier Cupissol

given: Didier

family: Peyrade

full_name: Frederic Peyrade

given: Frederic

family: Benasso

full_name: Marco Benasso

given: Marco

family: Vynnychenko

full_name: Ihor Vynnychenko

given: Ihor

family: De Raucourt

full_name: Dominique De Raucourt

given: Dominique

family: Bokemeyer

full_name: Carsten Bokemeyer

given: Carsten

family: Schueler

full_name: Armin Schueler

given: Armin

family: Amellal

full_name: Nadia Amellal

given: Nadia

family: Hitt

full_name: Ricardo Hitt

given: Ricardo

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Platinum-Based Chemotherapy plus Cetuximab in Head and Neck Cancer

ReferenceCitation: Fayette J, Montella A, Chabaud S, Bachelot T, Pommier P, Girodet D, Racadot S, Montbarbon X, Favier B, Zrounba P. Paclitaxel is effective in relapsed head and neck squamous cell carcinoma: a retrospective study of 66 patients at a single institution. Anticancer Drugs. 2010 Jun;21(5):553-8. doi: 10.1097/CAD.0b013e3283388e60.

ReferenceCitation: Sherr CJ. Cancer cell cycles. Science. 1996 Dec 6;274(5293):1672-7. Review.

ReferenceCitation: Ortega S, Malumbres M, Barbacid M. Cyclin D-dependent kinases, INK4 inhibitors and cancer. Biochim Biophys Acta. 2002 Mar 14;1602(1):73-87. Review.

ReferenceCitation: Shapiro GI. Cyclin-dependent kinase pathways as targets for cancer treatment. J Clin Oncol. 2006 Apr 10;24(11):1770-83. Review.

ReferenceCitation: Sherr CJ, Roberts JM. CDK inhibitors: positive and negative regulators of G1-phase progression. Genes Dev. 1999 Jun 15;13(12):1501-12. Review.

ReferenceCitation: Michalides RJ, van Veelen NM, Kristel PM, Hart AA, Loftus BM, Hilgers FJ, Balm AJ. Overexpression of cyclin D1 indicates a poor prognosis in squamous cell carcinoma of the head and neck. Arch Otolaryngol Head Neck Surg. 1997 May;123(5):497-502.

ReferenceCitation: Akervall JA, Michalides RJ, Mineta H, Balm A, Borg A, Dictor MR, Jin Y, Loftus B, Mertens F, Wennerberg JP. Amplification of cyclin D1 in squamous cell carcinoma of the head and neck and the prognostic value of chromosomal abnormalities and cyclin D1 overexpression. Cancer. 1997 Jan 15;79(2):380-9.

ReferenceCitation: Liggett WH Jr, Sewell DA, Rocco J, Ahrendt SA, Koch W, Sidransky D. p16 and p16 beta are potent growth suppressors of head and neck squamous carcinoma cells in vitro. Cancer Res. 1996 Sep 15;56(18):4119-23.

ReferenceCitation: Kothari V, Mulherkar R. Inhibition of cyclin D1 by shRNA is associated with enhanced sensitivity to conventional therapies for head and neck squamous cell carcinoma. Anticancer Res. 2012 Jan;32(1):121-8.

ReferenceCitation: Chung CH, Zhang Q, Kong CS, Harris J, Fertig EJ, Harari PM, Wang D, Redmond KP, Shenouda G, Trotti A, Raben D, Gillison ML, Jordan RC, Le QT. p16 protein expression and human papillomavirus status as prognostic biomarkers of nonoropharyngeal head and neck squamous cell carcinoma. J Clin Oncol. 2014 Dec 10;32(35):3930-8. doi: 10.1200/JCO.2013.54.5228. Epub 2014 Sep 29.

location_facility:
Hôpital Saint-André
Centre Antoine Lassagne
Centre Léon Bérard


title: Orthoptic Rehabilitation for Low Vision People With Innovative Mechanisms (Eye Tracker and Tactile Device)

acronym: VISIONUM

summary:
This project is working on orthoptic rehabilitation for low vision people. The aim of the project is to assess the interest and integration of this rehabilitation device used at home, in low-vision private practice and at the hospital. It leads to develop and evaluate an innovative device to integrate and adjust monitoring of patients according to their need and their progress, to create new interactions with the patient, enabling the orthoptist to stay in touch with his patient at home between rehabilitation sessions and to obtain a more fine and objective analysis of the exercises done by the patient.

Using an eye tracker and a digital tactile screen with data uploads allows the practitioner to observe the progress objectively. It also leads the patient to a better understanding of his/her visual behavior and of the effects of rehabilitation. Therefore, it will be easier to adopt better strategies.

status: Terminated

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts


title: Impact of New Biomarkers on the Maintenance of Sinus Rhythm After Cardioversion or Ablation of Atrial Fibrillation

acronym: Biorhythm

summary: The Biorhythm study aims to investigate the utility of new biomarkers (e.g. MR proANP, ST2) measured pre-procedure for the prediction of procedural success in patients with atrial fibrillation undergoing cardioversion or ablation.

ReferenceCitation: Badoz M, Serzian G, Favoulet B, Sellal JM, De Chillou C, Hammache N, Laurent G, Mebazaa A, Ecarnot F, Bardonnet K, Seronde MF, Schiele F, Meneveau N. Impact of Midregional N-Terminal Pro-Atrial Natriuretic Peptide and Soluble Suppression of Tumorigenicity 2 Levels on Heart Rhythm in Patients Treated With Catheter Ablation for Atrial Fibrillation: The Biorhythm Study. J Am Heart Assoc. 2021 Jul 6;10(13):e020917. doi: 10.1161/JAHA.121.020917. Epub 2021 Jun 30.

name: Department of CardiologyUniversity Hospital Besançon Besançon France

name: EA3920University of Burgundy Franche‐Comté Besançon France

family: Badoz

full_name: Marc Badoz

given: Marc

family: Serzian

full_name: Guillaume Serzian

given: Guillaume

family: Favoulet

full_name: Baptiste Favoulet

given: Baptiste

name: Department of Cardiology Centre Hospitalier Régional Universitaire de NancyUniversité de Lorraine Nancy France

name: IADIINSERM U1254Université de Lorraine Nancy France

family: Sellal

full_name: Jean‐Marc Sellal

given: Jean‐Marc

family: De Chillou

full_name: Christian De Chillou

given: Christian

family: Hammache

full_name: Néfissa Hammache

given: Néfissa

name: Department of Cardiology University Hospital François Mitterand Dijon France

family: Laurent

full_name: Gabriel Laurent

given: Gabriel

name: Department of Anesthesiology and Critical Care Medicine Assistance Publique ‐ Hôpitaux de ParisSaint Louis Lariboisière University Hospitals Paris France

family: Mebazaa

full_name: Alexandre Mebazaa

given: Alexandre

family: Ecarnot

full_name: Fiona Ecarnot

given: Fiona

name: Department of BiochemistryUniversity Hospital Besançon Besançon France

family: Bardonnet

full_name: Karine Bardonnet

given: Karine

family: Seronde

full_name: Marie‐France Seronde

given: Marie‐France

family: Schiele

full_name: François Schiele

given: François

family: Meneveau

full_name: Nicolas Meneveau

given: Nicolas

journal_name: Journal of the American Heart Association

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Impact of Midregional N‐Terminal Pro–Atrial Natriuretic Peptide and Soluble Suppression of Tumorigenicity 2 Levels on Heart Rhythm in Patients Treated With Catheter Ablation for Atrial Fibrillation: The Biorhythm Study

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
University Hospital Jean Minjoz
CHU Brabois
CHU François Mitterand

intervention_type: Procedure


title: Diagnostic Value of the CardioSecur Connected EcG in General Care: The Connected EGG-study.

acronym: CARDIOSECUR

summary: Heart disease symptoms are a frequent reason of consultation in general medical practice. Only a few general practitioners are equipped with a 12 lead Electrocardiography (ECG) whereas this test is extremely useful for diagnosis orientation in cases of cardiac diseases.Cardiosecur allows the realization of a 15 or 22 leads ECG with only 4 electrodes connected to a smartphone or a tablet with an automatic interpretation function. The goal of the study is to evaluate the diagnostic value of Cardiosecur device regarding cardiac symptoms in family practice.

time_perspective: Cross-Sectional

lead_sponsor: Lille Catholic University


title: TNF in Melanoma Patients Treated With Immunotherapy

acronym: MELANFα

summary:
This trial is a translational proof-of-concept, open-label, prospective cohort study of 60 patients aiming to identify the clinical markers and/or biomarkers associated with therapeutic response to immune checkpoints inhibitors, in patients with advanced melanoma.

The study will be conducted on a population of patients treated with ICI in the context of routine care, separated in two subgroups:

Subgroup 1: patients treated with anti-PD-1 alone (nivolumab or pembrolizumab)
Subgroup 2: patients treated with the combined treatment anti-PD-1+anti-CTLA-4 (nivolumab + ipilimumab)

For each included patient, blood samples will be collected during baseline visit and during treatment period (at Week 6 Day 1 and Week 12 Day 1).

If feasible, tumor biopsy (of primary tumor or metastasis) will be performed during baseline and on Week 12 Day 1 visit (predose). If tumor biopsy is not feasible, available archived tumor specimen (frozen or FFPE block) may be collected for the study.

All included patients will be followed-up for tumor status and/or survival status every 3 months until a maximum duration of 1 year from the first study dose.

lead_sponsor: Institut Claudius Regaud

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole


title: Evaluation of Intestinal Bacterial and Fungal Translocation and Intestinal Microbiota in Febrile Neutropenic Patients in Pediatric Onco-hematology

acronym: TRANSNEUTROFEB

summary: This pilot study aims to study intestinal bacterial and fungal translocation and the evolution of the intestinal microbiota in patients over the course of their medical surveillance to search for a link between dysbiosis and bacterial/fungal translocation, but also to better understand the elements involved in febrile episodes in these patients (lack of detection of blood microorganisms, translocation of constituent elements of these microorganisms, etc.). We hypothesize that the composition of the intestinal microbiota as well as the phenomenon of intestinal microbial translocation will have an influence on the occurrence of fever and/or bacteremia in neutropenic patients hospitalized in pediatric onco-hematology.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: UFR de Pharmacie Laboratoire de Parasitologie et Mycologie Médicale


title: A Randomized, Controlled, Multicenter, Prospective, Open Study Evaluating the Efficiency of the IsereADOM Home-care Service Package in the Prevention of Unplanned Hospitalizations of Patients With Cancer

acronym: IsereADOM

summary: The main objective of the project is to compare the effectiveness and efficiency of innovative care through the IsereADOM home-care service package versus standard care in the prevention of unplanned hospitalizations in patients with cancer treatment. In accordance with the recommendations of the French High Authority of Health (HAS), a cost-utility analysis (ACU) will be implemented

primary_purpose: Prevention

lead_sponsor: Centre Leon Berard

location_facility:
Institut Daniel Hollard
Centre Léon Bérard
CHU Grenoble Alpes


type: EudraCT Number

title: Clinical Trial Assessing the Efficacy of Capsaicin Patch (Qutenza®) in Cancer Patients With Neuropathic Pain

acronym: CAPSONCO

summary: In the oncology area, neuropathic pains are relatively frequent and can be induced by surgery, radiotherapy, or chemotherapy. In usual practice, some units are using qutenza in order to reduce neuropathic pain even though using of this patch for a population of cancer patients has never been demonstrated so far in a prospective study. The present prospective study proposes to evaluate the qutenza efficacy in peripheric neuropathic pain in cancer patients.

lead_sponsor: Institut de Cancérologie de la Loire

location_facility: Institut de Cancérologie Lucien Neuwirth


title: Reference Curve on Bone Mineral Density in Young Adult: French Multicenter Study

acronym: COURDO

summary: In men, the hope of lower life, the absence of equivalent of menopause and the existence of a higher peak bone mass are three factors that explain the lower incidence of osteoporosis in men. Epidemiological data indicate a prevalence of 15% among men aged over 50 years (Szulc et al. 2000). According to global analyzes, the number of fractures of the upper end of the femur in humans will increase from 400 000 to 800 000 per year between 2000 and 2025 (Kanis et al. 2004). Furthermore the mortality due to major osteoporotic fractures when they occur in humans than that seen in women (Johnell and al.2001).The main goal of this study is to establish reference curves in elderly male volunteers from 20 to 30 years through the assessment of bone mineral density of the spine, hip, and the measurement of body composition (fat mass, lean mass). This study will allow us to establish the mean and standard deviation of the value of the young adults of the same sex, which will eventually be applied in the calculation of the "T-score" for older people.

ReferenceCitation: Abrahamsen B, Hansen TB, Jensen LB, Hermann AP, Eiken P. Site of osteodensitometry in perimenopausal women: correlation and limits of agreement between anatomic regions. J Bone Miner Res. 1997 Sep;12(9):1471-9.

ReferenceCitation: Ahmed AI, Blake GM, Rymer JM, Fogelman I. Screening for osteopenia and osteoporosis: do the accepted normal ranges lead to overdiagnosis? Osteoporos Int. 1997;7(5):432-8.

ReferenceCitation: Baumgartner RN. Body composition in elderly persons: a critical review of needs and methods. Prog Food Nutr Sci. 1993 Jul-Sep;17(3):223-60. Review.

location_facility:
CHRU Lyon
Chru Lille
CHR Orléans


title: Circulating Tumor DNA as an Early Marker of Recurrence and Treatment Efficacy in Ovarian Carcinoma

acronym: CIDOC

summary: Prospective multicentre assay to assess ctDNA value for ovarian cancer monitoring and disease recurrence after front-line treatment.

primary_purpose: Basic Science

lead_sponsor: Institut Paoli-Calmettes

location_facility:
Centre Jean Perrin
Institut Du Cancer de Montpellier
Centre Oscar Lambret


title: A Phase-I Study of Nivolumab in Association With Radiotherapy and Cisplatin in Locally Advanced Cervical Cancers Followed by Adjuvant Nivolumab for up to 6 Months. NiCOL

acronym: NiCOL

summary: To date, the majority of clinical trials on checkpoint inhibitors have tested these agents as monotherapy, and the next logical step is to evaluate rational therapeutic associations. The aim of the NiCOL study is to assess the safety of nivolumab in association with chemoradiation therapy and to gain initial insight into its efficacy in association with the current standard of care, including chemoradiation.

lead_sponsor: Institut Curie

location_facility:
Institut Curie Hopital René Huguenin
Institut Curie
Hopital Européen Georges Pompidou

intervention_type: Radiation


title: Descriptive Assessment of Practice in Anaesthesia : Lidocaine 1% Adrenaline Under in Axillary Block Realization

acronym: fLACON

summary:
Axillary block is the good anesthetic technique for upper limb surgery without exceeding a certain total dose injected of Local Anesthetic (AL).

The maximal recommended dose of Lidocaine adrenaline in the upper limb is 500 mg. The use of ultrasound helps guiding the locoregional anesthesia, and allows to decrease the AL concentration, thus decreasing the risks.

No previous study estimated a concentration of lidocaine lower than 1,5 % to realize upper limb surgery by axillary block.

The literature overestimating probably the rate of failure of the locoregional anesthesia under ultrasound-guidance, we suggest to estimate the rate of failure of the axillary block ultrasound-guided with the lidocaine 1 % adrenaline for realizing upper limb surgery in standard practice.

lead_sponsor: University Hospital, Brest

location_facility: Centre Hospitalier Intercommunal de Cornouaille


title: Kinetics of Perioperative Circulating DNA in Cancer Surgery

acronym: Periop ctDNA

summary: The aim of this study was to determine the kinetics of perioperative circulating DNA in three types of cancer. This first step will enable further studies comparing the potential impact of certain techniques or anesthetic products on cancer surgery.

location_facility:
Institut de Cancérologie Montpellier
CHU Montpellier
CHU Nimes


title: Comparison of the Prevalence of Sleep Disorders in Transient Ischemic Attack and Stroke

acronym: SOMN'AIC

summary: Sleep disorders in the setting of stroke are numerous, including sleep-related breathing disorders, insomnia, excessive daytime sleepiness and restless legs syndrome. Consequences of theses sleep disturbances include impaired functional outcome and quality of life, anxious and depressive troubles and increased cardio-vascular morbi-mortality. Mechanisms underlying sleep disorders in the setting of stroke are complex and still partly elucidated. They probably involve the consequences of the ischemic lesion and of the handicap, but also of associated vascular risk factors and more generally pre-existent medical history, or they could represent themselves a risk factor for stroke. Transient ischemic attack (TIA) is a particular condition in which risk factors and background of patients are similar to that observed in stroke, without any cerebral lesion and no persistent neurological deficit. The main objective of the SOMN'AIC study is to compare the prevalence of sleep disorders in stroke and in transient ischemic attack (TIA). The study hypothesis is that the prevalence of sleep disorders may be higher in stroke than in TIA patients, reflecting the consequences of the lesion and the associated handicap.

lead_sponsor: Hospices Civils de Lyon

location_facility: Sleep Medicine Center, Croix-Rousse Hospital, Hospices Civils de Lyon

location_facility: Service de Neurologie Vasculaire Groupement Hospitalier Est

location_facility: Service de MPR- Hôpital Henry Gabrielle - Groupement Sud


title: Assessment Study to Evaluate Specific Immune Response in Locally Advanced Cervix Cancer After Radio-chemotherapy (IMMUVIX)

acronym: IMMUVIX

summary:
Perspectives:

To set-up another clinical trial with this specific phenotype as the main stratification factor. Therefore a more aggressive or a more specific systemic treatment (with or without an immunomodulator) could be proposed to those selected patients in the field of personalized medicine.
To evaluate the use of the smear as a surrogate non-invasive technique to biopsy for immunomonitoring.
To use the CTC/PD-L1 assay as a liquid biopsy in future clinical trials for stratification and monitoring of cancer patients undergoing immune checkpoint treatments. This specific subset of CTCs might represent metastatic cells with a high potential to escape T cell-mediated lysis and might therefore be the actual targets of immunotherapy.

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ReferenceCitation: Piersma SJ, Jordanova ES, van Poelgeest MI, Kwappenberg KM, van der Hulst JM, Drijfhout JW, Melief CJ, Kenter GG, Fleuren GJ, Offringa R, van der Burg SH. High number of intraepithelial CD8+ tumor-infiltrating lymphocytes is associated with the absence of lymph node metastases in patients with large early-stage cervical cancer. Cancer Res. 2007 Jan 1;67(1):354-61.

ReferenceCitation: de Vos van Steenwijk PJ, Ramwadhdoebe TH, Goedemans R, Doorduijn EM, van Ham JJ, Gorter A, van Hall T, Kuijjer ML, van Poelgeest MI, van der Burg SH, Jordanova ES. Tumor-infiltrating CD14-positive myeloid cells and CD8-positive T-cells prolong survival in patients with cervical carcinoma. Int J Cancer. 2013 Dec 15;133(12):2884-94. doi: 10.1002/ijc.28309. Epub 2013 Jul 5.

ReferenceCitation: Sznol M, Chen L. Antagonist antibodies to PD-1 and B7-H1 (PD-L1) in the treatment of advanced human cancer. Clin Cancer Res. 2013 Mar 1;19(5):1021-34. doi: 10.1158/1078-0432.CCR-12-2063.

ReferenceCitation: Karim R, Jordanova ES, Piersma SJ, Kenter GG, Chen L, Boer JM, Melief CJ, van der Burg SH. Tumor-expressed B7-H1 and B7-DC in relation to PD-1+ T-cell infiltration and survival of patients with cervical carcinoma. Clin Cancer Res. 2009 Oct 15;15(20):6341-7. doi: 10.1158/1078-0432.CCR-09-1652. Epub 2009 Oct 13.

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ReferenceCitation: Bastid J, Cottalorda-Regairaz A, Alberici G, Bonnefoy N, Eliaou JF, Bensussan A. ENTPD1/CD39 is a promising therapeutic target in oncology. Oncogene. 2013 Apr 4;32(14):1743-51. doi: 10.1038/onc.2012.269. Epub 2012 Jul 2. Review.

ReferenceCitation: Bastid J, Regairaz A, Bonnefoy N, Déjou C, Giustiniani J, Laheurte C, Cochaud S, Laprevotte E, Funck-Brentano E, Hemon P, Gros L, Bec N, Larroque C, Alberici G, Bensussan A, Eliaou JF. Inhibition of CD39 enzymatic function at the surface of tumor cells alleviates their immunosuppressive activity. Cancer Immunol Res. 2015 Mar;3(3):254-65. doi: 10.1158/2326-6066.CIR-14-0018. Epub 2014 Nov 17.

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ReferenceCitation: Steinert G, Schölch S, Niemietz T, Iwata N, García SA, Behrens B, Voigt A, Kloor M, Benner A, Bork U, Rahbari NN, Büchler MW, Stoecklein NH, Weitz J, Koch M. Immune escape and survival mechanisms in circulating tumor cells of colorectal cancer. Cancer Res. 2014 Mar 15;74(6):1694-704. doi: 10.1158/0008-5472.CAN-13-1885. Epub 2014 Mar 5.

ReferenceCitation: Mazel M, Jacot W, Pantel K, Bartkowiak K, Topart D, Cayrefourcq L, Rossille D, Maudelonde T, Fest T, Alix-Panabières C. Frequent expression of PD-L1 on circulating breast cancer cells. Mol Oncol. 2015 Nov;9(9):1773-82. doi: 10.1016/j.molonc.2015.05.009. Epub 2015 Jun 9.

ReferenceCitation: Golden EB, Apetoh L. Radiotherapy and immunogenic cell death. Semin Radiat Oncol. 2015 Jan;25(1):11-7. doi: 10.1016/j.semradonc.2014.07.005. Review.

ReferenceCitation: Delgado FG, Martínez E, Céspedes MA, Bravo MM, Navas MC, Cómbita Rojas AL. Increase of human papillomavirus-16 E7-specific T helper type 1 response in peripheral blood of cervical cancer patients after radiotherapy. Immunology. 2009 Apr;126(4):523-34. doi: 10.1111/j.1365-2567.2008.02912.x. Epub 2008 Sep 5.

ReferenceCitation: Lim K, Small W Jr, Portelance L, Creutzberg C, Jürgenliemk-Schulz IM, Mundt A, Mell LK, Mayr N, Viswanathan A, Jhingran A, Erickson B, De los Santos J, Gaffney D, Yashar C, Beriwal S, Wolfson A, Taylor A, Bosch W, El Naqa I, Fyles A; Gyn IMRT Consortium. Consensus guidelines for delineation of clinical target volume for intensity-modulated pelvic radiotherapy for the definitive treatment of cervix cancer. Int J Radiat Oncol Biol Phys. 2011 Feb 1;79(2):348-55. doi: 10.1016/j.ijrobp.2009.10.075. Epub 2010 May 14.

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

location_facility:
Clinique Beausoleil
CHRU Montpellier
ICM Val d'Aurelle

intervention_type: Combination Product


type: Other Identifier

title: Respiratory Outcome According to Early Maternal Vitamin D Status During Pregnancy in Children Aged 5 to 6 Years Old

acronym: RESPIFEPED

summary: Early lung function deficits represent a significant risk factor for the evolution toward chronic obstructive pulmonary disease later in life. Prematurity and in utero tobacco smoke exposure are already known to predispose children to develop a non-reversible obstructive ventilatory defect in adulthood. The role of vitamin D status during pregnancy is less certain. In humans, low vitamin D concentrations during pregnancy are associated to an increased risk of asthma in children. In murine models, low vitamin D concentrations during pregnancy are associated to structural abnormalities of the airways in mouse pups. Investigators hypothesized that vitamin D play a role in early airways development, from the first trimester of pregnancy. To bring arguments to this hypothesis, the investigators will study the association of airway resistance in children aged 5 to 6 years old with the concentration of vitamin D during the first trimester of pregnancy in their mothers.

ReferenceCitation: Chawes BL, Bønnelykke K, Stokholm J, Vissing NH, Bjarnadóttir E, Schoos AM, Wolsk HM, Pedersen TM, Vinding RK, Thorsteinsdóttir S, Arianto L, Hallas HW, Heickendorff L, Brix S, Rasmussen MA, Bisgaard H. Effect of Vitamin D3 Supplementation During Pregnancy on Risk of Persistent Wheeze in the Offspring: A Randomized Clinical Trial. JAMA. 2016 Jan 26;315(4):353-61. doi: 10.1001/jama.2015.18318.

ReferenceCitation: Litonjua AA, Carey VJ, Laranjo N, Harshfield BJ, McElrath TF, O'Connor GT, Sandel M, Iverson RE Jr, Lee-Paritz A, Strunk RC, Bacharier LB, Macones GA, Zeiger RS, Schatz M, Hollis BW, Hornsby E, Hawrylowicz C, Wu AC, Weiss ST. Effect of Prenatal Supplementation With Vitamin D on Asthma or Recurrent Wheezing in Offspring by Age 3 Years: The VDAART Randomized Clinical Trial. JAMA. 2016 Jan 26;315(4):362-70. doi: 10.1001/jama.2015.18589.

ReferenceCitation: Wolsk HM, Harshfield BJ, Laranjo N, Carey VJ, O'Connor G, Sandel M, Strunk RC, Bacharier LB, Zeiger RS, Schatz M, Hollis BW, Weiss ST, Litonjua AA. Vitamin D supplementation in pregnancy, prenatal 25(OH)D levels, race, and subsequent asthma or recurrent wheeze in offspring: Secondary analyses from the Vitamin D Antenatal Asthma Reduction Trial. J Allergy Clin Immunol. 2017 Nov;140(5):1423-1429.e5. doi: 10.1016/j.jaci.2017.01.013. Epub 2017 Mar 9.

ReferenceCitation: Gazibara T, den Dekker HT, de Jongste JC, McGrath JJ, Eyles DW, Burne TH, Reiss IK, Franco OH, Tiemeier H, Jaddoe VW, Duijts L. Associations of maternal and fetal 25-hydroxyvitamin D levels with childhood lung function and asthma: the Generation R Study. Clin Exp Allergy. 2016 Feb;46(2):337-46. doi: 10.1111/cea.12645.

ReferenceCitation: Lange P, Celli B, Agustí A, Boje Jensen G, Divo M, Faner R, Guerra S, Marott JL, Martinez FD, Martinez-Camblor P, Meek P, Owen CA, Petersen H, Pinto-Plata V, Schnohr P, Sood A, Soriano JB, Tesfaigzi Y, Vestbo J. Lung-Function Trajectories Leading to Chronic Obstructive Pulmonary Disease. N Engl J Med. 2015 Jul 9;373(2):111-22. doi: 10.1056/NEJMoa1411532.

ReferenceCitation: Postma DS, Bush A, van den Berge M. Risk factors and early origins of chronic obstructive pulmonary disease. Lancet. 2015 Mar 7;385(9971):899-909. doi: 10.1016/S0140-6736(14)60446-3. Epub 2014 Aug 11. Review.

ReferenceCitation: Belgrave DC, Buchan I, Bishop C, Lowe L, Simpson A, Custovic A. Trajectories of lung function during childhood. Am J Respir Crit Care Med. 2014 May 1;189(9):1101-9. doi: 10.1164/rccm.201309-1700OC.

location_facility:
Robert Debré Hospital
Armand Trousseau Hospital
Necker Enfants-malades Hospital


title: Efficacy of a Cold, Vibration, and Distraction Based Medical Device on the Prevention of Health Care Induced Pediatric Pain: a Comparative, Controlled, Randomized and Multicentric Study

acronym: DOLVAX

summary:
In vaccination centers, venipunctures and vaccinations are sources of pain and anxiety in pediatric patients. Prior painful experiences can reduce the acceptance of later health care, hence making it more difficult for both patients and nurses.

The topical anesthetic cream (lidocaine, prilocaine) and the non-pharmacological (distraction and relaxation) interventions which are usually used for prevention of procedural pain impose certain constraints on families and on vaccination centers.

A distraction and local anesthesia (cold and vibration) based medical device (Buzzy®) could overcome these constraints and could be an interesting alternative for healthcare management in vaccination centers and, in a broader perspective, in other medical services.

Research on this device has been scarce to date. Three of them have shown an efficacy of Buzzy® in comparison to the absence of prevention of vaccination and venipuncture induced pain. An ongoing study will assess the Buzzy® device in comparison to a topical anesthetic cream, but will be set in an emergency department context. To date, no study has compared Buzzy® to topical anesthetic cream on healthy children in a vaccination center.

The research team has formulated the following hypothesis: the Buzzy® device will allow to get a not lower or an equivalent level of pain compared to the level of pain obtained with the usual topical anesthetic cream. The aim of this study is to evaluate the efficacy of the device Buzzy® on vaccination and venipuncture induced pain in a vaccination center.

primary_purpose: Supportive Care

lead_sponsor: Nantes University Hospital

location_facility:
La Roche sur Yon University Hospital
Nantes University Hospital
Le Mans University Hospital


title: Home Respiratory Rehabilitation in Patients With Lung Cancer Non-small Cell Advanced or Metastatic Treated With Oral Targeted Therapy

summary:
The feasibility and impact of respiratory rehabilitation (RR) in patients with advanced or metastatic (EGF-R WT or mutated) non-small cell lung cancer treated with oral targeted therapy including Inhibitors of EGF-R tyrosine kinases (TKI) and ALK inhibitors.

These patients will benefit, at the beginning of the chemotherapy whatever the treatment line, of a respiratory rehabilitation. The respiratory rehabilitation takes place at the patient's home with the HAD's cooperation 3 hours per week, divided into 2 or 3 sessions. There is associated educational, nutritional and psychological support for a total duration of 8 weeks.

lead_sponsor: University Hospital, Lille

location_facility:
Centre hospitalier Victor Provo
Hôpital privé La Louvière
Hôpital Calmette, CHRU


title: Ultrasound Assessment of Residual Gastric Content in Critically Ill Patients

acronym: GastrICU

summary: This prospective observational study aims to assess whether ultrasound assessment of gastric content may be useful for the monitoring of the gastric residual content in critically ill patients

ReferenceCitation: Bouvet L, Zieleskiewicz L, Loubradou E, Alain A, Morel J, Argaud L, Chassard D, Leone M, Allaouchiche B; AzuRea CAR'Echo collaborative networks. Reliability of gastric suctioning compared with ultrasound assessment of residual gastric volume: a prospective multicentre cohort study. Anaesthesia. 2020 Mar;75(3):323-330. doi: 10.1111/anae.14915. Epub 2019 Dec 4.

name: Department of Anaesthesia and Intensive Care Hospices Civils de Lyon Hôpital Femme Mère Enfant Lyon France

name: Department of Anaesthesia and Intensive Care APCSe VetAgro Sup UPSP 2016.A101 Marcy‐l'Etoile France

family: Bouvet

full_name: L. Bouvet

given: L.

name: Department of Anaesthesia and Intensive Care Hôpital Nord Assistance Publique –Hôpitaux de Marseille Marseille France

family: Zieleskiewicz

full_name: L. Zieleskiewicz

family: Loubradou

full_name: E. Loubradou

given: E.

family: Alain

full_name: A. Alain

given: A.

name: Department of Anaesthesia and Intensive Care Centre Hospitalier Universitaire de Saint‐Étienne Saint‐Étienne France

family: Morel

full_name: J. Morel

given: J.

name: Department of Anaesthesia and Intensive Care Civils de Lyon Groupement Hospitalier Centre Lyon France

family: Argaud

full_name: L. Argaud

family: Chassard

full_name: D. Chassard

given: D.

family: Leone

full_name: M. Leone

given: M.

name: Department of Anaesthesia and Intensive Care Hospices Civils de Lyon Groupement Hospitalier Sud Pierre‐Bénite Cedex France

family: Allaouchiche

full_name: B. Allaouchiche

given: B.

name: the AzuRea CAR'Echo collaborative networks

journal_name: Anaesthesia

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Hôpital Edouard Herriot

location_facility:
Hôpital Nord
Centre Hospitalier Lyon Sud
CHU Saint Etienne


title: French Aquablation Clinical Investigation Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue

summary: Single arm, multi-center prospective clinical trial to determine the safety and effectiveness of the AQUABEAM System in the treatment of benign prostatic hyperplasia (BPH) in men 45 to 80 years of age.

lead_sponsor: PROCEPT BioRobotics

location_facility:
Clinique Pasteur
CHU de Limoges
Hôpital Cochin


title: A Systematic Ultrasound Assessment During Intubation Procedure to Predict Cardiovascular Collapse Related to Intubation in the Intensive Care Unit: a Prospective, Multiple-center Study

acronym: EPIC

summary:
In the operating room, most intubation procedures (IP) are scheduled and performed on hemodynamically stable patients. In the ICU, IP is frequently performed in emergent patients, because of unstable hemodynamics and/or acute respiratory failure, and complicated by a subsequent cardiovascular collapse. Transthoracic echocardiography (TTE) has become readily available in most ICUs for several years. Echocardiography enables to perform a noninvasive hemodynamic evaluation (cardiac function and volemia status).

We hypothesized that performing a TTE prior to IP may help to predict cardiovascular collapse and its components.

ReferenceCitation: Jaber S, Jung B, Corne P, Sebbane M, Muller L, Chanques G, Verzilli D, Jonquet O, Eledjam JJ, Lefrant JY. An intervention to decrease complications related to endotracheal intubation in the intensive care unit: a prospective, multiple-center study. Intensive Care Med. 2010 Feb;36(2):248-55. doi: 10.1007/s00134-009-1717-8. Epub 2009 Nov 17.

location_facility: Hôpital d'Instruction des Armées Clermont Tonnerre


title: Performance Assessment of 7 Biomarkers for the Diagnosis of Severe Bacterial Infections in Children Aged From 7 Days to 36 Months.

acronym: ANTOINE

summary:
ANTOINE is a prospective trial which aims to assess diagnostic performance of 7 biomarkers for the diagnosis of severe bacterial infections (SBI) in children aged from 7 days to 36 months.

Fever is a frequent cause of consultation in pediatric emergency departments. Clinical diagnostic tools are rare and discrimination between severe bacterial infection and viral infection is difficult to confidently state. The prevalence of severe bacterial infections (IBS) varies from 10 to 25% according to the studies. Biological markers such as procalcitonin (PCT) and C-reactive protein (CRP) are commonly used in clinical practice. These markers have bacterial specificity but share a wide range of values with viral infections and do not make it possible to exclude or to confirm definitively the diagnosis of IBS. The use of new markers to improve the diagnosis of bacterial and viral infections is increasingly studied in adults. The diagnostic value of these new markers has been demonstrated by associating their dosage with that of CRP for example. This is the case for IP-10, TRAIL or MxA. However, very few pediatric studies have been carried out to date on these new biomarkers. However, in pediatrics, these diagnostic tools based on the combination of biomarkers to discriminate against viral and bacterial infections could be a major help in the suspicions of IBS. 7 biomarkers were selected to be evaluated in this study. This study is designed to determine the best biomarkers combination for the SBI diagnosis on a cohort of 800 patients.

ReferenceCitation: Trouillet-Assant S, Viel S, Ouziel A, Boisselier L, Rebaud P, Basmaci R, Droz N, Belot A, Pons S, Brengel-Pesce K, Gillet Y, Javouhey E; Antoine Study Group. Type I Interferon in Children with Viral or Bacterial Infections. Clin Chem. 2020 Jun 1;66(6):802-808. doi: 10.1093/clinchem/hvaa089.

name: Joint Research Unit Hospices Civils de Lyon-bioMérieux, Hospices Civils de Lyon, Lyon Sud Hospital, Pierre-Bénite, France

name: Virologie et Pathologie Humaine - Virpath Team, Centre International de Recherche en Infectiologie (CIRI), INSERM U1111, CNRS UMR5308, ENS Lyon, Claude Bernard Lyon University, Lyon, France

family: Trouillet-Assant

full_name: Sophie Trouillet-Assant

given: Sophie

name: Immunoly Laboratory, Hospices Civils de Lyon, Lyon Sud Hospital, Pierre-Bénite, France

name: Immunité innée dans les maladies infectieuses et autoimmunes team, Centre International de Recherche en Infectiologie (CIRI), INSERM U1111, CNRS UMR5308, ENS Lyon, Claude Bernard Lyon University, Lyon, France

name: National Referee Centre for Rheumatic and AutoImmune and Systemic diseases in childrEn (RAISE), Lyon, France

family: Viel

full_name: Sébastien Viel

given: Sébastien

name: Pediatric Emergency Unit, Hôpital Femme Mère Enfants, Hospices Civils of Lyon, Lyon, France

family: Ouziel

full_name: Antoine Ouziel

given: Antoine

family: Boisselier

full_name: Lucille Boisselier

given: Lucille

name: Pediatric Emergency Unit, Hôpital Nord-Ouest, CH de Villefranche-sur-Saône, Gleizé, France

family: Rebaud

full_name: Philippe Rebaud

given: Philippe

name: Pediatric Emergency Unit, AP-HP, Louis-Mourier Hospital, Colombes, France

name: Paris University, INSERM, Infection, Antimicrobiens, Modélisation, Evolution (IAME), Paris, France

family: Basmaci

full_name: Romain Basmaci

given: Romain

family: Droz

full_name: Nina Droz

given: Nina

name: Pediatric Nephrology, Rheumatology, Dermatology Unit, Hospices Civils de Lyon, Lyon, France

family: Belot

full_name: Alexandre Belot

family: Pons

full_name: Sylvie Pons

given: Sylvie

family: Brengel-Pesce

full_name: Karen Brengel-Pesce

given: Karen

family: Gillet

full_name: Yves Gillet

given: Yves

name: EA7426: Pathophysiology of Injury-Induced Immunosuppression, University of Lyon, Lyon, France

family: Javouhey

full_name: Etienne Javouhey

given: Etienne

family: Mommert

full_name: Marine Mommert

given: Marine

family: Guichard

full_name: Audrey Guichard

given: Audrey

family: Bartolo

full_name: François Bartolo

family: Generenaz

full_name: Laurence Generenaz

given: Laurence

family: Pachot

full_name: Alexandre Pachot

family: Capella

full_name: Claire Capella

given: Claire

family: Hees

full_name: Laure Hees

given: Laure

family: Mezgueldi

full_name: Ellia Mezgueldi

given: Ellia

family: Toumi

full_name: Chadia Toumi

given: Chadia

family: Bouchiat-Sarabi

full_name: Coralie Bouchiat-Sarabi

given: Coralie

family: Casalegno

full_name: Jean-sebastien Casalegno

given: Jean-sebastien

repository_institution: St George's University of London - St George's Online Research Archive

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

location_facility:
Hôpital Nord Ouest
Hospices Civils de Lyon
Hôpital Louis Mourier - APHP


title: Study of the Correlation Between UltraSonography and Dual-Energy Computed Tomography Assessment of Urate Deposit in Urate Lowering Therapy Initiators

acronym: GOUT

summary: The objective of this research is to evaluate the correlation between DECT and US explorations performed in a routine clinical setting for the measurement of change in tophus size in gout patients after 24 months of treatment.

location_facility: Hospital Group of the Catholic Institute


title: Alpha-synuclein Level in the Saliva as a Potential Diagnostic Aid to Differentiate Between Idiopathic Parkinson Disease and Iatrogenic Parkinsonian Syndrome

acronym: PARKSYN

summary: The aim of this study is to determine whether a significant reduction in the total level of alpha-synuclein and significant increase in the oligomeric form of alpha-synuclein and therefore the ratio oligomeric:total alpha-synuclein occurs in patients with Parkinson disease compared to patients with drug-induced parkinsonian syndrome.

location_facility:
Hôpital Gui de Chauliac
CHU Nimes
Hôpital St Eloi


title: Efficacy and Safety of a 0.1% Tacrolimus Nasal Ointment as a Treatment for Epistaxis in Hemorrhagic Hereditary Telangiectasia (HHT) - A Double Blind, Randomized, Placebo-controlled, Multicenter Trial

acronym: TACRO

summary:
The recognized manifestations of HHT are all due to abnormalities in vascular structure. Epistaxis due to telangiectases formation is spontaneous, very variable, recurrent in 90% of patients, and associated with severe anemia in 2-10%. They also significantly reduce quality of life.

Improvement in epistaxis has been shown in HHT patients after a liver transplantation. It was hypothesized that the immunosuppressive treatment (FK506) used to prevent rejection may have an anti-angiogenic effect.

The results of Albiñana et al suggest that the mechanism of action of FK506 involves a partial correction of endoglin and ALK1 haplosufficiency, genes responsible for 90% of HHT case.

Tacrolimus ointment is available on the market for the treatment of eczema and can therefore readily be used as it is for nasal administration. Topical nasal administration of tacrolimus may be an easy local ENT treatment that is non-aggressive and results in little trauma for the patient in relation to other first line treatment possibilities.

The main objective of this trial is to evaluate, at 6 weeks after the end of the treatment, the efficacy on the duration of nosebleeds, of 6 weeks tacrolimus nasal ointment application, in patients with HHT complicated by nosebleeds (30 min/6 weeks). Secondary objectives are to evaluate the tolerance throughout the study, the efficacy on anemia and on clinical parameters (nosebleeds, quality of life, epistaxis severity score questionnaire and blood transfusions) and the systemic absorption of nasal administration.

This is a multicenter prospective and double blinded phase I/II trial. A total of 48 patients will be randomized versus placebo using an allocation ratio of 1:1. The ointment (Protopic® at 0.1% or placebo) will be self-administered by the patient with one administration in each nostril twice a day for 6 consecutive weeks.

location_facility:
CHU de Montpellier
CHU Estaing
Hôpital Femme Mère Enfant


title: Exhaustive Genetic and Immunological Characterization of Colon, Kidney and Liver Tumors to Define Potential Targets of Targeted and/or Immunomodulatory Therapies

acronym: ExhauCRF

summary:
Over the last 10 years, technological advances in molecular biology enabled a more accurate genomic characterization of tumors. For each tumor location, this led to the identification of subgroups with similar molecular characteristics. This identification allowed the development of targeted therapies and thus to improve the patient prognosis. This molecular characterization has also revealed the tumor heterogeneity. It may be the cause of treatment resistance and therefore of relapses. Additionally, tumor cells are in constant dialogue with their microenvironment composed of different immune or non immune cells. This microenvironment is now targeted in cancer treatment.

To date, there are few studies that combine a deep genomic characterization of both tumor and tumor microenvironment of the patient. Combining the two types of studies on the same tumor should help to define new therapeutic targets and should allow a combination of targeted and immunomodulatory therapies. To this end, our project is to conduct an exhaustive integrated exploratory analysis at genomic, transcriptomic and immunological levels of 3 tumor types (in colon, kidney and liver cancer).

study_start_date_type: Anticipated

time_perspective: Other

ipd_sharing_description: The IPD (individual participant data) will not be shared. To protect confidentiality and integrity of patient information, only investigators of the study will have a regulated access to data with authorizations.

lead_sponsor: European Georges Pompidou Hospital

location_facility: AP-HP European Georges Pompidou Hospital


title: Prevention of Pain Caused by the Oro-gastric Tube Laying in Neonatology

acronym: DOLATSONG

summary: Subject of research : Evaluation of a technique of care to reduce the pain caused by the laying of the gastric tube in the newborn

lead_sponsor: Centre Hospitalier Sud Francilien

location_facility:
Centre Hospitalier de Saint-Denis
Groupe Hospitalier Paris Saint-Joseph
Centre Hospitalier Sud Francilien


title: Sit-to-stand Test Use in Children and Adolescents With Cystic Fibrosis : Correlations With 6-Minute Walking Test, Quadriceps and Respiratory Muscle Strength and Health Related Quality of Life

summary:
Cystic fibrosis (CF) is a chronic hereditary respiratory disease. Exercise testing is part of CF patients regular assessment.

Cardio-Pulmonary Exercise Testing (CPET) is currently considered as the gold standard to assess physical capacities. However, simple field tests are emerging. These tests are easier to perform especially in a population of CF children and adolescents.

The 1minute Sit-To-Stand test have recently been evaluated in CF adults. This test correlates with maximal oxygen consumption during CPET.

The investigators hypothesized that this test also correlates with 6-Minute Walking distance (during a 6-min Walk Test), quadriceps strength, respiratory muscles strength and health-related quality of life.

ReferenceCitation: Radtke T, Puhan MA, Hebestreit H, Kriemler S. The 1-min sit-to-stand test--A simple functional capacity test in cystic fibrosis? J Cyst Fibros. 2016 Mar;15(2):223-6. doi: 10.1016/j.jcf.2015.08.006. Epub 2015 Sep 9.

ReferenceCitation: Ozalevli S, Ozden A, Itil O, Akkoclu A. Comparison of the Sit-to-Stand Test with 6 min walk test in patients with chronic obstructive pulmonary disease. Respir Med. 2007 Feb;101(2):286-93. Epub 2006 Jun 27.

ReferenceCitation: Hussey J, Gormley J, Leen G, Greally P. Peripheral muscle strength in young males with cystic fibrosis. J Cyst Fibros. 2002 Sep;1(3):116-21.

ReferenceCitation: Combret Y, Boujibar F, Gennari C, Medrinal C, Sicinski S, Bonnevie T, Gravier FE, Laurans M, Marguet C, Le Roux P, Lamia B, Prieur G, Reychler G. Measurement properties of the one-minute sit-to-stand test in children and adolescents with cystic fibrosis: A multicenter randomized cross-over trial. PLoS One. 2021 Feb 12;16(2):e0246781. doi: 10.1371/journal.pone.0246781. eCollection 2021.

family: Combret

full_name: Yann Combret

given: Yann

family: Boujibar

full_name: Fairuz Boujibar

given: Fairuz

family: Gennari

full_name: Charlotte Gennari

given: Charlotte

family: Medrinal

full_name: Clément Medrinal

given: Clément

family: Sicinski

full_name: Sophie Sicinski

given: Sophie

family: Bonnevie

full_name: Tristan Bonnevie

given: Tristan

family: Gravier

full_name: Francis-Edouard Gravier

given: Francis-Edouard

family: Laurans

full_name: Muriel Laurans

given: Muriel

family: Marguet

full_name: Christophe Marguet

given: Christophe

family: Le Roux

full_name: Pascal Le Roux

given: Pascal

family: Lamia

full_name: Bouchra Lamia

given: Bouchra

family: Prieur

full_name: Guillaume Prieur

given: Guillaume

family: Reychler

full_name: Grégory Reychler

given: Grégory

journal_name: PLOS ONE

lead_sponsor: Groupe Hospitalier du Havre

location_facility:
CHU de Rouen
Hôpital Côte de Nacre
Le Havre Hospital


title: Quantitative Ultrasound Assessment of Gastric Volume in Diabetic and Non Diabetic Patients Scheduled for a General Anesthesia

acronym: ECHODIABETE

summary: The main objective is to compare the frequency of a " full stomach " in diabetic patients compared with a control population, all the patients having followed the instructions of preoperative fast.

lead_sponsor: Hopital Foch

location_facility: Fondation Ophtalmologique Adolphe de Rotschild


title: Efficacy of Tools Associated With a Multifaceted Education Intervention Directed to Health Professionals to Reduce Medication Preparation and Administration Error Rates in Neonatal Intensive Care Units

acronym: OREANE

summary: The purpose of this study is to determine whether an educational program for caregivers associated with convenient tools is effective to reduce medication preparation and administration errors in the Neonatal Intensive Care Units (NICU).

lead_sponsor: University Hospital, Bordeaux

location_facility: Service de pédiatrie - Hôpital Pellegrin


title: Efficacy and Safety of Early Administration of Tranexamic Acid in Cirrhotic Patients Presenting With Acute Upper Gastrointestinal Bleeding: a Multicenter, Randomized, Double Blind, Placebo-controlled Trial (Modified by amendment1)

acronym: EXARHOSE

summary:
Upper digestive bleeding. Upper gastrointestinal haemorrhage is a common cause of decompensated cirrhosis and is associated with a high mortality rate among cirrhotic patients. Its leading cause is the rupture of gastro-esophageal varices due to portal hypertension. In cirrhotic patients, the management of acute gastrointestinal haemorrhage is challenging as they often present with coagulation (or haemostasis abnormalities) abnormalities such as hyperfibrinolysis, especially when the cirrhosis is decompensated. Beyond life support measures, therapeutic modalities of upper gastrointestinal bleeding rely on both endoscopic and pharmacological interventions. Tranexamic acid (TA) is an antifibrinolytic that may help control the bleeding in this setting, as it showed an unquestionable benefit in other indications. TA has previously been studied in both upper gastrointestinal haemorrhage from any causes and in liver transplantation of cirrhotic patients. However, there is a lack of data to conclude on its effectiveness (or efficiency) in the early treatment of acute bleeding in cirrhotic patients.

Investigators hypothesize that, when given early, TA would be beneficial for cirrhotic patients presenting with acute upper gastrointestinal haemorrhage , by controlling the haemorrhage, avoiding rebleeding episodes and reducing mortality within 5 days after its administration. Moreover, TA could prevent early cirrhosis complications (such as hepatic encephalopathy, sepsis and ascites liquid infection, hepatorenal syndrome), could reduce indications to transjugular portosystemic shunt (TIPS), shorten the length of stay in intensive care unit and the length of hospitalization, and decrease late relapses and one-year mortality.

ReferenceCitation: Heidet M, Amathieu R, Audureau E, Augusto O, Nicolazo de Barmon V, Rialland A, Schmitz D, Pierrang F, Marty J, Chollet-Xémard C, Thirion O, Jacob L. Efficacy and tolerance of early administration of tranexamic acid in patients with cirrhosis presenting with acute upper gastrointestinal bleeding: a study protocol for a multicentre, randomised, double-blind, placebo-controlled trial (the EXARHOSE study). BMJ Open. 2018 Aug 10;8(8):e021943. doi: 10.1136/bmjopen-2018-021943.

family: Heidet

full_name: Matthieu Heidet

given: Matthieu

family: Amathieu

full_name: Roland Amathieu

given: Roland

family: Audureau

full_name: Etienne Audureau

given: Etienne

family: Augusto

full_name: Oriane Augusto

given: Oriane

family: Nicolazo de Barmon

full_name: Violaine Nicolazo de Barmon

given: Violaine

family: Rialland

full_name: Amandine Rialland

given: Amandine

family: Schmitz

full_name: David Schmitz

given: David

family: Pierrang

full_name: François Pierrang

given: François

family: Marty

full_name: Jean Marty

given: Jean

family: Chollet-Xémard

full_name: Charlotte Chollet-Xémard

family: Thirion

full_name: Olivier Thirion

given: Olivier

family: Jacob

full_name: Line Jacob

given: Line

ReferenceCitation: Heidet M, Mermet É, Vaux J, Jérémie R, Audureau É, Marty J. Simulated EMS response times until patients located in public train stations: A geospatial model to improve on-foot accessibility. Resuscitation. 2018 Oct;131:e3-e5. doi: 10.1016/j.resuscitation.2018.07.031. Epub 2018 Aug 2.

family: Mermet

full_name: Éric Mermet

given: Éric

family: Vaux

full_name: Julien Vaux

given: Julien

location_facility:
Jean Verdier Hospital
Henri Mondor Hospital
Marc Jacquet Hospital


title: Reliability and Validity of the Elderly Mobility Scale for Frailty People Living at Home, French Version

summary: This study evaluates the reliability of the French version of the "elderly mobility scale" and its correlation with the "frailty elderly scale "

ReferenceCitation: Crocker T, Forster A, Young J, Brown L, Ozer S, Smith J, Green J, Hardy J, Burns E, Glidewell E, Greenwood DC. Physical rehabilitation for older people in long-term care. Cochrane Database Syst Rev. 2013 Feb 28;(2):CD004294. doi: 10.1002/14651858.CD004294.pub3. Review.

ReferenceCitation: Lihavainen K, Sipilä S, Rantanen T, Kauppinen M, Sulkava R, Hartikainen S. Effects of comprehensive geriatric assessment and targeted intervention on mobility in persons aged 75 years and over: a randomized controlled trial. Clin Rehabil. 2012 Apr;26(4):314-26. doi: 10.1177/0269215511423269. Epub 2011 Oct 17.

ReferenceCitation: Daniels R, Metzelthin S, van Rossum E, de Witte L, van den Heuvel W. Interventions to prevent disability in frail community-dwelling older persons: an overview. Eur J Ageing. 2010 Feb 9;7(1):37-55. doi: 10.1007/s10433-010-0141-9. eCollection 2010 Mar. Review.

ReferenceCitation: Clegg A, Barber S, Young J, Forster A, Iliffe S. The Home-Based Older People's Exercise (HOPE) trial: study protocol for a randomised controlled trial. Trials. 2011 Jun 8;12:143. doi: 10.1186/1745-6215-12-143.

ReferenceCitation: Clegg AP, Barber SE, Young JB, Forster A, Iliffe SJ. Do home-based exercise interventions improve outcomes for frail older people? Findings from a systematic review. Rev Clin Gerontol. 2012 Feb;22(1):68-78. Epub 2012 Aug 24.

ReferenceCitation: Morley JE, Vellas B, van Kan GA, Anker SD, Bauer JM, Bernabei R, Cesari M, Chumlea WC, Doehner W, Evans J, Fried LP, Guralnik JM, Katz PR, Malmstrom TK, McCarter RJ, Gutierrez Robledo LM, Rockwood K, von Haehling S, Vandewoude MF, Walston J. Frailty consensus: a call to action. J Am Med Dir Assoc. 2013 Jun;14(6):392-7. doi: 10.1016/j.jamda.2013.03.022.

ReferenceCitation: Guralnik JM, Ferrucci L, Simonsick EM, Salive ME, Wallace RB. Lower-extremity function in persons over the age of 70 years as a predictor of subsequent disability. N Engl J Med. 1995 Mar 2;332(9):556-61.

ReferenceCitation: Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls in community-dwelling older adults using the Timed Up & Go Test. Phys Ther. 2000 Sep;80(9):896-903.

ReferenceCitation: Downs S, Marquez J, Chiarelli P. Normative scores on the Berg Balance Scale decline after age 70 years in healthy community-dwelling people: a systematic review. J Physiother. 2014 Jun;60(2):85-9. doi: 10.1016/j.jphys.2014.01.002. Epub 2014 Jun 13. Review.

ReferenceCitation: C. for R. O. R. Rehabilitation Institute of Chicago, " Rehab Measures : Barthel Index Rehabilitation Measures Database ", 2014. [En ligne]. Disponible sur: http://www.rehabmeasures.org/Lists/RehabMeasures/PrintView.aspx?ID=916.

ReferenceCitation: Karpman C, Lebrasseur NK, Depew ZS, Novotny PJ, Benzo RP. Measuring gait speed in the out-patient clinic: methodology and feasibility. Respir Care. 2014 Apr;59(4):531-7. doi: 10.4187/respcare.02688. Epub 2013 Aug 27.

ReferenceCitation: Stineman MG, Shea JA, Jette A, Tassoni CJ, Ottenbacher KJ, Fiedler R, Granger CV. The Functional Independence Measure: tests of scaling assumptions, structure, and reliability across 20 diverse impairment categories. Arch Phys Med Rehabil. 1996 Nov;77(11):1101-8.

ReferenceCitation: C. Flahault, C. Généraux, A. Colvez, V. Royer, et S. Berthié-mourgaud, " ETUDE DE LA FIABILITE DE L ' INSTRUMENT AGGIR Reproductibilité ( test / re-test ) entre évaluateurs Dispersion des temps d ' aide requise entre Groupes Iso Ressources Enquête dans cinq départements Travail réalisé par Dans l ' Hérault Dans les Alpes marit ", 2005

ReferenceCitation: S. C. B. Ennie, K. A. B. Runer, et A. L. D. Izon, " Measurements of Balance : Comparaison of the Timed "up and Go" Test and Functional Reach Test with the Berg Balance Scale ", J. Phys. Ther. Sci., vol. 15, p. 93-97, 2003.

ReferenceCitation: Yu MS, Chan CC, Tsim RK. Usefulness of the Elderly Mobility Scale for classifying residential placements. Clin Rehabil. 2007 Dec;21(12):1114-20.

ReferenceCitation: Rolland Y, Benetos A, Gentric A, Ankri J, Blanchard F, Bonnefoy M, de Decker L, Ferry M, Gonthier R, Hanon O, Jeandel C, Nourhashemi F, Perret-Guillaume C, Retornaz F, Bouvier H, Ruault G, Berrut G. [Frailty in older population: a brief position paper from the French society of geriatrics and gerontology]. Geriatr Psychol Neuropsychiatr Vieil. 2011 Dec;9(4):387-90. French.

ReferenceCitation: Has, " Comment repérer la fragilité en soins ambulatoires ? ", Points clés Solut. Organ. des Parcour., 2013.

ReferenceCitation: Studenski S, Perera S, Patel K, Rosano C, Faulkner K, Inzitari M, Brach J, Chandler J, Cawthon P, Connor EB, Nevitt M, Visser M, Kritchevsky S, Badinelli S, Harris T, Newman AB, Cauley J, Ferrucci L, Guralnik J. Gait speed and survival in older adults. JAMA. 2011 Jan 5;305(1):50-8. doi: 10.1001/jama.2010.1923.

family: Studenski

full_name: Stephanie Studenski

given: Stephanie

journal_name: JAMA

oa_colors: green hybrid

evidence: open (via free pdf)

version: acceptedVersion

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

title: Gait Speed and Survival in Older Adults

ReferenceCitation: Abellan van Kan G, Rolland Y, Andrieu S, Bauer J, Beauchet O, Bonnefoy M, Cesari M, Donini LM, Gillette Guyonnet S, Inzitari M, Nourhashemi F, Onder G, Ritz P, Salva A, Visser M, Vellas B. Gait speed at usual pace as a predictor of adverse outcomes in community-dwelling older people an International Academy on Nutrition and Aging (IANA) Task Force. J Nutr Health Aging. 2009 Dec;13(10):881-9. Review.

ReferenceCitation: Collard RM, Boter H, Schoevers RA, Oude Voshaar RC. Prevalence of frailty in community-dwelling older persons: a systematic review. J Am Geriatr Soc. 2012 Aug;60(8):1487-92. doi: 10.1111/j.1532-5415.2012.04054.x. Epub 2012 Aug 6. Review.

family: Collard

full_name: Rose M. Collard

given: Rose M.

name: Department of Epidemiology; University Medical Center Groningen; University of Groningen; Groningen; the Netherlands

family: Boter

full_name: Han Boter

given: Han

name: University Center of Psychiatry & Interdisciplinary Center of Psychiatric Epidemiology; University Medical Center Groningen; University of Groningen; Groningen; the Netherlands

family: Schoevers

full_name: Robert A. Schoevers

given: Robert A.

family: Oude Voshaar

full_name: Richard C. Oude Voshaar

given: Richard C.

journal_name: Journal of the American Geriatrics Society

title: Prevalence of Frailty in Community-Dwelling Older Persons: A Systematic Review

ReferenceCitation: A. Cherubini, L. Demougeot, A. Cruz Jentoft, A. Curgunlu, J. P. Michel, H. Roberts, A. Aihie Sayer, T. Strandberg, E. Topinkova, F. M. Trotta, D. Z. B. Van Asselt, B. Vellas, D. Zekry, et M. Cesari, " Relationship between the Gérontopole Frailty Screening Tool and the frailty phenotype in primary care ", Eur. Geriatr. Med., vol. 6, no 6, p. 518-522, 2015.

ReferenceCitation: Chiu AY, Au-Yeung SS, Lo SK. A comparison of four functional tests in discriminating fallers from non-fallers in older people. Disabil Rehabil. 2003 Jan 7;25(1):45-50.

ReferenceCitation: Wrisley DM, Kumar NA. Functional gait assessment: concurrent, discriminative, and predictive validity in community-dwelling older adults. Phys Ther. 2010 May;90(5):761-73. doi: 10.2522/ptj.20090069. Epub 2010 Apr 1.

name: D.M. Wrisley, PT, PhD, NCS, is Assistant Professor, Department of Rehabilitation Science, State University of New York, University at Buffalo, 515 Kimball Tower, 3435 Main St, Buffalo, NY 14214 (USA).

family: Wrisley

full_name: Diane M. Wrisley

given: Diane M.

name: N.A. Kumar, PT, PhD, is Assistant Professor, Department of Rehabilitation Science, Texas Tech University Health Sciences Center, Odessa, Texas.

family: Kumar

full_name: Neeraj A. Kumar

given: Neeraj A.

journal_name: Physical Therapy

oa_host_type: publisher

title: Functional Gait Assessment: Concurrent, Discriminative, and Predictive Validity in Community-Dwelling Older Adults

ReferenceCitation: Smith, " Validation and Reliability of the Elderly Mobility Scale ", Physiotherapy, vol. 80 (11), no June 2012, p. 744-747, 1994.

ReferenceCitation: Thomas JI, Lane JV. A pilot study to explore the predictive validity of 4 measures of falls risk in frail elderly patients. Arch Phys Med Rehabil. 2005 Aug;86(8):1636-40.

location_facility:
Cabinet medical
Cabinet de kinésithérapie


title: GEriatric Determinants of Curative RAdiotherapy Scheme Choice for Breast Cancer ELderly Patient Treatment Compliance and Tolerance : GERABEL Study

acronym: GERABEL

summary: This study proposes an onco geriatric evaluation (Activities of Daily Living, Instrumental Activities Of Daily Living, Mini Mental State Examination, mini Geriatric Depression Scale, Mini Nutritional Assessment, Cumulative Illness Rating Scale-Geriatric, and " timed get up and go " tests) for elderly breast cancer patients. The score obtained at this evaluation will determine the radiotherapy scheme.

location_facility: Groupement Hospitalier Portes de Provence

location_facility: Institut de Cancérologie Lucien Neuwirth


title: Pharmacokinetics Study of Mycophenolic Acid in Patients With an Autoimmune Bullous Dermatose, Pemphigus or Cicatricial Pemphigoid.

acronym: PEMPA

summary: The main autoimmune bullous dermatoses are pemphigus and cicatricial pemphigoid. Pemphigus is an autoimmune dermatological disease characterized by the production of anti-desmoclesin antibodies 1 and 3, affecting the skin and mucous membranes.The cicatricial pemphigoid is an autoimmune dermatological disease, characterized by the production of anti-zone antibodies of the basal membrane and characterized by a predominant mucosal involvement. Mycophenolic acid (MPA) is an increasingly used form of corticosteroid. Despite its increasing use, pharmacokinetics in autoimmune bullous dermatosis remain little studied.

lead_sponsor: University Hospital, Limoges

location_facility:
CHU de Bordeaux
Hôpital Avicenne - AP-HP
CHU de Rouen


title: Brain Derived Neurotrophic Factor Serum Levels Evolution During the Six Months Following After Alcohol Withdrawal in Alcohol-dependent Subjects in Relation to Abstinence

summary:
Alcohol dependence is accompanied by several neurological mechanisms involving neuronal plasticity and neoneurogenesis, requiring Brain Derived Neurotrophic factor (BDNF) synthesis.

The investigators found that serum BDNF levels in alcohol-dependent subjects increased to a greater extent in subjects who had remained abstinent at 6 months after withdrawal than in subjects who had relapse.

To verify if the BDNF serum levels variation is linked to the way that abstinence is installed, wthe investigators will measure BDNF serum levels in alcohol dependent subjects at the moment of withdrawal, and 14, 28 days, and 2, 4, and 6 months after to establish its evolution in relation to alcohol consumption, and other clinical characteristics : depression intensity, anxiety, alcohol craving, biological markers of alcohol consumption or toxicity. Monitoring serum BDNF concentrations in link with other clinical data could help to characterize alcohol dependence profiles in clinical practice, help predict relapses, and assist in adjusting care to prevent difficulties in alcohol withdrawal.

ReferenceCitation: Costa MA, Girard M, Dalmay F, Malauzat D. Brain-derived neurotrophic factor serum levels in alcohol-dependent subjects 6 months after alcohol withdrawal. Alcohol Clin Exp Res. 2011 Nov;35(11):1966-73. doi: 10.1111/j.1530-0277.2011.01548.x. Epub 2011 Aug 16.

ReferenceCitation: Pareaud M, Girard M, Nubukpo P. Factors for Maintaining Abstinence at 2 and 6 Months After Alcohol Withdrawal. J Psychiatr Pract. 2021 Jan 21;27(1):2-13. doi: 10.1097/PRA.0000000000000522.

family: PAREAUD

full_name: MARINE PAREAUD

given: MARINE

family: GIRARD

full_name: MURIELLE GIRARD

given: MURIELLE

family: NUBUKPO

full_name: PHILIPPE NUBUKPO

given: PHILIPPE

bso_classification: Social sciences

journal_name: Journal of Psychiatric Practice

lead_sponsor: Centre Hospitalier Esquirol

location_facility:
Clinique Saint Maurice
Centre Hospitalier de Vauclaire
Centre Hospitalier Esquirol
Centre Hospitalier La Vallette